Академический Документы
Профессиональный Документы
Культура Документы
MRI Patient Monitoring System
Model 3160
SERVICE MANUAL
*989803173851*
REF 989803173851
Proprietary Information
This document contains proprietary information, which is protected by copyright.
Manufacturer
Invivo Corporation
Orlando, FL 32826
www.invivocorp.com
For service on your Invivo products, call 1‐877‐468‐4861.
Warranty
The information contained in this document is subject to change without notice. Invivo Corporation
makes no warranty of any kind with regard to this material, including, but not limited to, the implied
warranties or merchantability and fitness for a particular purpose. Invivo Corporation shall not be liable
for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this material.
Limits of Liability
Invivo has taken care to ensure the accuracy of this document. However, Invivo assumes no liability for
errors or omissions and reserves the right to make changes without further notice to any products
herein to improve reliability, function, or design. Invivo may make improvements or changes in the
product(s) or program(s) described in this document at any time.
Printing History
New revisions of this document will incorporate all material updated since the previous revision. Update
packages may be issued between revisions and contain replacement and additional pages to be merged
by a revision date at the bottom of the page. The documentation part number (REF) and revision
indicate the current edition.
REF 989803173851 Rev. A, February 2011
Copyright © 2011, Invivo Corporation
All rights reserved. Printed in U.S.A.
Contents
1.0—INTRODUCTION ........................................................................................................................... 1
1.1 About this Manual ......................................................................................................................... 1
1.2 Text Conventions ........................................................................................................................... 2
2.0—UNPACKING THE SYSTEM............................................................................................................. 3
3.0—SYSTEM OVERVIEW ................................................................................................................... 11
3.1 CART............................................................................................................................................. 12
3.1.1 Overview ....................................................................................................................... 12
3.1.2 CART Rear Panel Connections:.......................................................................................... 13
3.1.3 CART Patient Connections: ............................................................................................... 14
3.2 CRD............................................................................................................................................... 15
3.2.1 Overview ........................................................................................................................... 15
3.2.2 Rear Panel Connections: ................................................................................................... 15
3.3 WECG & WSPO2 Wireless Modules ............................................................................................. 16
3.2.1 Overview ........................................................................................................................... 16
3.3 WECG & WSPO2 Patient Connections: ................................................................................ 16
4.0—SYSTEM POWER......................................................................................................................... 17
4.1 DC Power...................................................................................................................................... 17
4.1.1 CART Battery Operation.................................................................................................... 17
4.1.2 CART Battery Installation and Removal ............................................................................ 17
4.1.3 CART Battery Charging Instructions .................................................................................. 18
4.1.4 WECG and WSpO2 Module Battery Operation................................................................. 18
4.1.5 Module Battery Installation and Removal ........................................................................ 18
4.1.6 Module Battery Charger.................................................................................................... 19
4.1.7 Safe Battery Use................................................................................................................ 22
4.1.8 Battery Disposal Instructions ............................................................................................ 22
4.2 AC POWER.................................................................................................................................... 23
4.2.1 CART AC Power Converter (REF 989803168201) .............................................................. 24
4.2.2 CRD AC Power Adapter ..................................................................................................... 25
5.0—SYSTEM SETUP........................................................................................................................... 27
5.1 CART............................................................................................................................................. 27
5.1.1 Initial Power Up................................................................................................................. 29
i
5.1.2 CART SERVICE(BIO‐MED) Feature ..................................................................................... 29
5.2 CRD............................................................................................................................................... 38
5.2.1 Initial Power Up................................................................................................................. 38
5.2.2 CRD SERVICE(BIO‐MED) Feature. ...................................................................................... 38
6.0—TEST AND INSPECTION ............................................................................................................... 47
6.1 When to Test................................................................................................................................ 47
6.2 Test and Inspection Matrix Checklist ........................................................................................... 47
6.3 Performance Assurance Test Checklist........................................................................................ 48
6.4 Recommended Frequency of Testing .......................................................................................... 49
6.5 Preventative Maintenance........................................................................................................... 49
6.6 Test Process Description and Requirements ............................................................................... 49
Test Equipment Requirements: .................................................................................................. 49
Additional Test Equipment (required ONLY for Bench Repair):.................................................. 50
Required Accessories: ................................................................................................................. 50
6.7 Test Process ................................................................................................................................. 51
Test Part I.0: Initial Setup ........................................................................................................... 51
Test Part 2.0: Power ON Test ..................................................................................................... 53
Test Part 3.0: Communication Verification and Power Icon Check ........................................... 54
Test Part 4.0: Keypad Verification.............................................................................................. 56
Test Part 5.0: Sound Verification ............................................................................................... 56
Test Part 6.0: Time and Date Verification .................................................................................. 56
Test Part 7.0: WECG Verification ............................................................................................... 56
Test Part 8.0: WSPO2 Verification.............................................................................................. 57
Test Part 9.0: PRINTER Verification (CRD).................................................................................. 58
Test Part 10.0: NIBP Verification................................................................................................ 59
Test Part 11.0: INVASIVE PRESSURE Verification ....................................................................... 64
Test Part 12.0: ANESTHETIC AGENTS Verification...................................................................... 65
Test Part 13.0: LOW‐FLOW ETCO2 Verification ......................................................................... 66
Test Part 14.0: RESPIRATION Verification .................................................................................. 67
Test Part 15.0: TEMPERATURE Verification ............................................................................... 68
Test Part 16.0: GATING Verification........................................................................................... 68
Test Part 17.0: RF TEST Verification ........................................................................................... 75
ii
APPENDIX A—CHANGING THE NETWORK NUMBER ........................................................................... 77
Changing the CART or CRD Network Number .................................................................................... 77
Changing the Wireless Modules Network Number ............................................................................ 78
APPENDIX B—SOFTWARE PROGRAM UPDATE ................................................................................... 81
Part 1—Determining Software Revision............................................................................................. 81
Part 2—Downloading the Software.................................................................................................... 82
Part 3—Software Upgrade.................................................................................................................. 83
3.1 CRD Program Update ........................................................................................................... 83
3.2 CRD Cold Start ...................................................................................................................... 85
3.3 CRD Program Recovery ........................................................................................................ 85
3.4 CART Program Update ......................................................................................................... 87
3.5 CART Cold Start .................................................................................................................... 89
3.6 CART Program Recovery ...................................................................................................... 90
APPENDIX C—REPLACEABLE EXTERNAL COMPONENTS ...................................................................... 91
CART DC Fuse...................................................................................................................................... 91
CART Water Trap ................................................................................................................................ 92
CART Disposable O2 Cell (REF 989803162051) .................................................................................. 93
CART / CRD Antenna (REF 453564060151)......................................................................................... 96
CART AC Power Adapter (REF 989803168201)................................................................................... 99
APPENDIX D—BATTERY TESTS.......................................................................................................... 103
CART Battery (REF 989803169491) +14.4 VDC Test ......................................................................... 103
Wireless Module Battery (REF 989803152881) +4.1 VDC Test ........................................................ 104
APPENDIX E—GATING...................................................................................................................... 105
APPENDIX F—TROUBLESHOOTING................................................................................................... 107
ANESTHETIC AGENTS ........................................................................................................................ 107
ECG .................................................................................................................................................. 110
ETCO2................................................................................................................................................ 120
IBP .................................................................................................................................................. 121
NIBP .................................................................................................................................................. 122
SPO2.................................................................................................................................................. 124
TEMPERATURE .................................................................................................................................. 127
KEYPAD FUNCTIONS.......................................................................................................................... 128
COMMUNICATION ............................................................................................................................ 130
APPENDIX G—CRD DATA OUTPUT ................................................................................................... 137
iii
iv
1.0—INTRODUCTION
This service manual is intended for use by qualified service personnel for the repair and
maintenance of the Precess MRI Patient Monitoring System (Model 3160—REF 865323 and
865485). This manual contains information regarding the installation, intended use,
accessories, and troubleshooting of a fully equipped Precess MRI Patient Monitoring System.
The terms “CART” and “CRD” are used throughout this document to refer to the configurations
of the Precess MRI Patient Monitoring System. Specific differences between configurations,
where applicable, are noted in the text. Some information in this manual may depict
monitoring features that your system does not contain. For information on features not
included in your system, contact Invivo or your Invivo sales representative. For additional
information about your accessories, please consult the documentation that accompanied the
accessory.
1.1 About this Manual
This manual contains the following sections:
Section 1: Introduction, page 1–2.
Section 2: Unpacking the System, pages 3–8.
Section 3: System Overview, pages 9–14.
Section 4: System Power, pages 15–26.
Section 5: System Installation, pages 27–46.
Section 6: Test and Inspection, pages 47–76.
Appendix A: Changing Network Number, pages 77‐80.
Appendix B: Software Program Update, pages 81‐92.
Appendix C: Replaceable External Components, pages 93‐104.
Appendix D: Battery Tests, pages 105‐106.
Appendix E: Gating, pages 107‐108.
Appendix F: Troubleshooting and Accuracy Checks, pages 109‐138.
Appendix G: CRD Data Output, pages 139‐142.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
1
REF 989803173851 SECTION 1.0: INTRODUCTION
Appendix H: Determining System Configuration, pages 143‐146.
Appendix I: Disassembly, pages 147‐156.
Appendix J: Interconnect Diagrams, pages 157‐162.
Appendix K: Service Parts, pages 163‐170.
Appendix L: Service Tags and Serial Number Labels and Locations, pages 171‐172.
Appendix M: Repair, Warranty, and Regulatory, pages 173‐174.
Appendix N: List of Symbols, pages 175‐178.
Appendix N: Product Specifications, pages 179‐183.
1.2 Text Conventions
The manual uses the following conventions for Warnings, Cautions, and Notes:
WARNING: A Warning calls attention to a condition or possible situation that could cause injury
to the user and/or patient.
CAUTION: A Caution calls attention to a condition or possible situation that could damage or
destroy the product or the user’s work.
Note: A Note calls attention to notable details or to conventions used within this text.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
2
2.0—UNPACKING THE SYSTEM
WARNING: To reduce the possibility of damage to the equipment or injury to patient/personnel,
perform all tests and repairs outside of the MR system room.
This section provides instructions regarding the unpacking and inspection of the Precess MRI Patient
Monitoring System. Remove the system components from the shipping container(s). Verify the
presence of all ordered items against the included packing list and purchase request. Carefully examine
all components for any damage that may have occurred during shipment. Save the packing materials
and related shipping documents, as these will be required to process a claim with the carrier if damage
during shipment occurred. To resolve any issues or concerns with your order or product, or to report
shipping damage, contact Invivo Customer Service; see Warranty.
CAUTION: The Precess MRI Patient Monitoring System must be used and stored according to the
environmental specifications in Appendix A of the Instructions for Use (IFU) manual.
Failure to follow these specifications can affect the accuracy of the Precess MRI Patient
Monitoring System.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
3
REF 989803173851 SECTION 2: UNPACKING THE SYSTEM
865323 (3160 Precess) CART
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
4
REF 989803173851 SECTION 2: UNPACKING THE SYSTEM
Step Action
1. Open the 4 Snaps that secure the lid to the crate. Remove the lid (A) from the crate.
2. Remove the Accessories Box (B).
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
5
REF 989803173851 SECTION 2: UNPACKING THE SYSTEM
3. Remove the Foam Inserts (C) & (D).
4. Carefully raise the crate (E), unlock the wheels and then roll out the CART. Remove the
remaining Inserts (F) & (G) from the CART.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
6
REF 989803173851 SECTION 2: UNPACKING THE SYSTEM
Installing the Module Holder (Kit REF 989803174561)
Install the module holder onto the CART as follows:
Step Action
1. Slide the Module Holder (A) onto the Support pole (see illustration below) and align the top
screw hole.
2. Install the #4‐40 x 1/4 Flat Head Hex Screw (B) in the top hole.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
7
REF 989803173851 SECTION 2: UNPACKING THE SYSTEM
3. Securely tighten the screw with the Hex Key (C).
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
8
REF 989803173851 SECTION 2: UNPACKING THE SYSTEM
865485 (3160 Precess) CRD
Step Action
1 Open the shipping box and remove Spacer (A), Accessories Box (B), and lift CRD out and
remove Foam Inserts (C).
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
9
REF 989803173851 SECTION 2: UNPACKING THE SYSTEM
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
10
3.0—SYSTEM OVERVIEW
System Configuration
The base configuration consists of the following primary components:
One Wireless Processing Unit (CART) with Display, plus NIBP accessories
Two CART Batteries
AC Line Cord
Additional components that are available:
Control Room Display (CRD), plus AC Adapter
Wireless ECG Module, with battery and accessories
Wireless SPO2 Module, with battery and accessories
Module Battery Charger, plus AC Adapter
Optional Parameters that are available:
Anesthetic Agents
Low‐Flow ETCO2
Dual Channel Invasive Pressures
Surface Temperature
Respiration
Printer (CRD ONLY)
Language (Keypad and Menus): English, German, Spanish, French, Italian, Portuguese, Danish,
Swedish, Norwegian, Dutch
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
11
REF 989803173851 SECTION 3.0: SYSTEM OVERVIEW
3.1 CART
3.1.1 Overview
The Precess MRI Patient Monitoring System Cart is MR conditional and features a wheeled pedestal
design with integrated display panel, connection, processing and power units. As illustrated in the front
and rear views above, this self‐contained monitoring solution includes holders and hooks provide
storage for modules, cables and sample lines.
The display panel on the Cart provides monitoring information and control inside the MR system room.
The display panel contains controls for complete patient monitoring.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
12
REF 989803173851 SECTION 3.0: SYSTEM OVERVIEW
3.1.2 CART Rear Panel Connections:
Item# Description Comments
Located behind the Access Door is the USB port and the DC Fuse.
The USB programming port provides for the attachment of an
Invivo flash drive unit for performing automatic (SmartBoot)
Hinged Maintenance
1 reprogramming of the CART’s operating software. This port does
Access Door
not support any other USB device. The FU39 5A, 32V power fuse
provides over current protection for the +18 Vdc input power
from the AC Power Adapter.
The waste gas exhaust port is used for release of waste gas. It is
Waste Gas Exhaust
2 constructed to allow for connection into any existing Gas
Port
Scavenge system.
The Gating port provides for the connection of a cardiac / pulse
3 Gating Port synchronization interface to an MRI scanner equipped with gating
capability.
4 DC Inlet
5 Power Indicator
6 DC Outlet
7 Shield Cap
8 DC Cord
The disposable oxygen sensor (located behind the rear access
panel) is used when the monitor is equipped with the anesthetic
9 Oxygen Sensor
agent option to measure concentration of oxygen in the room air
and to/from the patient.
10 AC Inlet
11 Strain Relief
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
13
REF 989803173851 SECTION 3.0: SYSTEM OVERVIEW
3.1.3 CART Patient Connections:
Item# Description Comments
The water trap is used when a Gas Option is installed. The Gas
Gas Input Port and
1 Input Port allows for measurement of the optional EtCO2/
Water Trap
Anesthetic Agent patient parameter.
The NIBP ports provide for the connection of the NIBP patient
2 NIBP Ports
cuff.
EtCO2 Zero The EtCO2 Zero port is used for zeroing of the optional
3
Connection EtCO2/Anesthetic Agent Gas module.
P1/D1 and P2/D2 IBP The IBP ports provide for the connection of two IBP probes for
4
Connections taking patient invasive blood pressure measurements.
The Temperature port provides for the connection of a FISO
Temperature
5 Temperature probe for taking patient surface temperature
Connector
measurements.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
14
REF 989803173851 SECTION 3.0: SYSTEM OVERVIEW
3.2 CRD
3.2.1 Overview
The Control Room Display (CRD) panel provides information and control for remote operations from
inside the MR control room. The display panel contains controls for complete patient monitoring,
though the CRD differs slightly from the CART display as noted throughout this document and the IFU.
3.2.2 Rear Panel Connections:
Note: The battery release buttons that are shown are “dummy” buttons. No batteries are
installable in the CART display or the CRD.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
15
REF 989803173851 SECTION 3.0: SYSTEM OVERVIEW
Behind Access Panel:
RS‐232 Serial Connection.
USB Programming Port. The USB programming port provides for the attachment of an Invivo
flash drive unit for performing automatic (SmartBoot) reprogramming of the CRD’s operating
software. This port does not support any other USB device.
3.3 WECG & WSPO2 Wireless Modules
3.2.1 Overview
The wireless modules are battery operated and communicate through a bidirectional 2.4 GHz link, which
is automatically established upon system power‐up. Status indications are described below.
3.3 WECG & WSPO2 Patient Connections:
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
16
4.0—SYSTEM POWER
4.1 DC Power
4.1.1 CART Battery Operation
The CART has two batteries (REF 989803169491) located on the underside of the unit.
The lower portion of the CART display or CRD contains the System Status area, dedicated to
displaying the battery and wireless communication status; see Test Part 3.0 in Section 6.0. (Refer to
Precess Instruction for Use (IFU) manual for a full explanation of the Battery Status Display).
Maximum operation time of the CART batteries is approximately 8 hours when anesthetic Agents
and CO2 are turned off, and NIBP, ECG, and SpO2 parameters are running at 5‐minute intervals.
Battery operation time will be reduced by up to 2 hours when performing certain operations such as
anesthetic agents monitoring, or running short automatic NIBP cycle times.
When the AC mains power is interrupted and batteries in the Cart are inserted, the Precess
automatically switches to internal batteries.
Note: To prevent unintentional power interruption, Invivo recommends keeping the batteries
inserted in the equipment, even when operating under AC mains power.
4.1.2 CART Battery Installation and Removal
WARNING: The batteries used within the CART contain some ferrous materials that are attracted
to the MR magnetic field. DO NOT install or remove the batteries from the devices
when these units are closer than the 1,000 Gauss (0.1 T) field line as measured from
the center line of the MR bore. The batteries will be attracted to the magnetic field,
possibly causing patient or user injury.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
17
REF 989803173851 SECTION 4.0: SYSTEM POWER
CAUTION: Never force a battery into the battery compartment; damage to the battery or the
Precess MRI Patient Monitoring System will occur.
To install batteries into the CART, the batteries must be oriented properly to latch into place in the
battery compartments, as the battery contours fit the device geometry. Slide the batteries into their
respective compartments and they will automatically latch into place. If the battery does not latch
automatically when fully inserted into the battery compartment, then the battery is not positioned
properly. In this case, reorient the battery then retry installation.
To remove batteries from the CART, press the battery eject button on the device and the battery will
partially eject for easy removal.
4.1.3 CART Battery Charging Instructions
Charge the CART batteries before use. When installing the system for the first time, all batteries
must be charged at least 12 hours with AC power to the Precess turned off so that the batteries are
fully charged and conditioned for operation.
The CART batteries are charged by integrated intelligent battery chargers. These intelligent charging
devices automatically provide the appropriate profile needed to efficiently charge and condition the
batteries. When the CART is plugged into AC power and turned off, the battery charger is functional
and will automatically charge the batteries. When the CART is turned ON, it operates from AC power
and charges the batteries simultaneously.
4.1.4 WECG and WSpO2 Module Battery Operation
The WSpO2 and WECG modules have interchangeable 9065 batteries (REF 989803152881). These
batteries slide and latch into the battery slots in the WECG and WSpO2 modules.
4.1.5 Module Battery Installation and Removal
CAUTION: The 9065 Battery and wireless module should not be placed in the Field of View to
minimize the chance of image artifact.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
18
REF 989803173851 SECTION 4.0: SYSTEM POWER
Note: The WECG and WSpO2 module batteries are non‐magnetic and can be removed and
replaced from the modules while in the MR room.
To install batteries into the WSpO2 and WECG modules, slide a battery into the battery slot in the
module until the battery latches (on each side) into place.
To remove batteries from the WSpO2 or WECG modules, simultaneously press the latches on both
sides of the battery then slide the battery out of the module.
4.1.6 Module Battery Charger
The Wireless ECG and SpO2 module batteries must be charged by the stand‐alone supplied battery
charger (REF 9023). Indications of battery capacity are also available via the CART DCU display or the
CRD; see the Precess Operations manual. The minimum battery voltage value for normal operation
is 3.4V.
The Invivo Wireless Module Battery Charger (9023) is used offline to charge the 9065 batteries that
power the WECG and WSPO2 modules and can be mounted or placed on the desktop outside of the
MR Room.
WARNING: Do not use the Module battery Charger (REF 9023) and the Power Module
(453564152341) inside the MR system room. These devices are magnetic and will be
pulled into the MR system.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
19
REF 989803173851 SECTION 4.0: SYSTEM POWER
(Item 1) ‐ Battery Charger Power Indicator. This green LED indicates that +5 Vdc input power is
being supplied to the battery charger from the Power Module (453564152341).
(Item 2) ‐ Battery Bay Indicator – 4 ea. These LEDs indicates the charging status of the battery
when inserted into the Battery Bays.
Solid Green ‐ Indicates the associated battery is fully recharged and ready for
reuse.
Flashing Green ‐ Indicates the associated battery currently has a medium charge
and is successfully recharging.
Flashing Yellow ‐ Indicates the associated battery currently has a low charge
and is successfully recharging.
Solid Red ‐ Indicates a faulty or dead battery (properly dispose the associated
battery).
Solid Blue ‐ Indicates the battery in the lower, left‐hand battery bay is currently
in a reconditioning discharge cycle.
Flashing Blue ‐ Indicates the associated battery requires reconditioning. (The
battery must be inserted into the lower, left‐hand battery bay to be
reconditioned.)
Extinguished ‐ Indicates no battery is inserted in the associated battery bay.
(Item 3) ‐ Battery Bay – 4 ea. Each Battery Bay provides for the insertion of Part Number 9065
Lithium Battery for recharging purposes.
(Item 4) ‐ Reconditioning Button. The Reconditioning Button is provided to allow the user to
accept reconditioning of Part Number 9065 Lithium Battery when there is a flashing
blue LED indicator. Reconditioning will result in a longer down time for the battery
being reconditioned.
The Invivo Wireless Module Battery Charger system consists of four separate charger bays. When a
battery is inserted into the charger, the associated LED will light to indicate the status of the battery.
This charge indicator will change colors as the status of the battery changes during the charging
cycle. The battery indicator will remain lit with a solid green LED when the battery is charged to
within 5% of the full value (4.2 VDC). See the table below for the list of LED indications.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
20
REF 989803173851 SECTION 4.0: SYSTEM POWER
LED Condition LED Indication
YELLOW FLASHING Low battery charging. Battery capacity < 70%.
GREEN FLASHING Medium battery charging. Battery capacity > 70%.
GREEN SOLID Charge complete. Battery capacity > 95%.
Charger malfunction.
RED FLASHING** Charge control has been lost.
Remove battery.
Battery fault.
RED SOLID*
A charging parameter of current, voltage, temperature, or
time has exceeded limits.
Battery capacity reconditioning requested.
BLUE FLASHING***
The battery Smart Chip requests a re‐assessment of battery
capacity.
BLUE SOLID Reconditioning in progress.
NO COLOR No battery detected.
If the indicator is showing a RED LED, remove power from the battery charger to allow it to
reset and then re‐apply power and use as normal. If after resetting the battery charger the LED
again shows RED, then there is a fault in the battery or battery bay.
* If the indicator is showing a SOLID RED LED, this is indicating a fault in the battery. If the
battery has been removed and re‐inserted into the same battery bay or another bay, and during
the charge cycle again shows SOLID RED, then the battery needs to be replaced.
** If the indicator shows a RED FLASHING LED, this is indicating that there may be a fault in that
battery bay. Remove and re‐insert the battery into the battery bay. If during the charge cycle
the indicator again shows FLASHING RED, then that battery bay is no longer usable. Try
inserting the battery into another bay. If the indicator on the alternate bay shows that it is
charging normally, then when the LED is SOLIDGREEN, the battery is completely charged and
usable.
*** During the first 15 seconds of inserting the battery, if the indicator shows a BLUE FLASHING
LED, the chip in the battery is requesting that the battery be reconditioned. If this is ignored,
the battery will go through its normal recharge cycle, but the Invivo MRI Monitor may not give
the correct indication of battery life. To recondition the battery, it must be moved to Battery
Bay 3 and the Reconditioning Button pressed. Reconditioning takes 8 hours.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
21
REF 989803173851 SECTION 4.0: SYSTEM POWER
4.1.7 Safe Battery Use
The following warnings, cautions, and notes shall be observed to ensure the safety of operators and
patients.
WARNING: Stop using any battery that exhibits abnormal heat, odor, color, deformation or is in
an abnormal condition. If a battery is punctured or liquid leaks onto your skin or
clothing, wash skin and clothing with fresh water immediately. If liquid leaks from a
battery and gets into your eyes, do not rub your eyes. Wash eyes well with clean
water and consult a doctor immediately.
CAUTION: If the battery terminals become dirty, wipe them with a clean dry cloth before use.
Keep the battery terminals away from metal objects.
Note: Batteries have life cycles. If the time that the battery is powering the equipment becomes
much shorter than usual, the battery life is at an end. Remove a battery with an expired
life cycle from the equipment immediately. Replace the battery with a new Invivo specified
battery.
4.1.8 Battery Disposal Instructions
The Precess MRI Patient Monitoring System uses lithium‐polymer and lithium‐ion batteries that are
subject to strict disposal regulations for user and environmental safety.
CAUTION: Never heat or throw the battery into a fire. Heating the battery will damage the safety
circuitry, which can cause rupture or ignition of the battery.
Batteries must be stored in a dry place, at a temperature between 0°C to 40°C.
The Precess MRI Patient Monitoring System uses rechargeable batteries that contain
hazardous material. These batteries must be recycled or disposed of properly. Refer to
disposal guidelines listed below. Do not disassemble or incinerate the battery.
Guidelines in Europe
The European Community (EC) has issued two directives regarding battery disposal:
91/157/EEC and 93/86/EEC. Each member country implements these independently. Thus,
in each country the manufacturers, importers, and users are responsible for the proper
disposal or recycling of batteries. Confirm proper disposal requirements with your healthcare
facility or distributor.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
22
REF 989803173851 SECTION 4.0: SYSTEM POWER
Guidelines in the United States
The U.S. Federal Environmental Protection Agency (EPA) hazardous waste regulations, as conveyed
by the Resources Conservation and Recovery Act (RCRA), neither specifically list nor exempt lithium
batteries. The only metal of possible concern in the battery is the lithium metal that is not listed or
characterized as a toxic hazardous waste. Significant amount of spent cells and batteries that are
untreated and not fully discharged are considered as reactive hazardous waste. Thus, hazardous
waste of spent cells and batteries can be disposed after they are first neutralized through an
approved secondary treatment prior to disposal (as required by U.S. Land Ban Restriction of the
Hazardous and Solid Waste Amendments of 1984). Disposal of spent batteries must be performed
by authorized, professional disposal company, which has the knowledge in the requirements of the
Federal, the State and the Local authorities regarding hazardous materials, transportation, and
waste disposal. Confirm proper disposal requirements with your healthcare facility, distributor,
and/or local EPA office.
4.2 AC POWER
Primary Power Distribution Diagram
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
23
REF 989803173851 SECTION 4.0: SYSTEM POWER
4.2.1 CART AC Power Converter (REF 989803168201)
CAUTION: Performance of the Precess MRI Patient Monitoring System and any other devices
within the room may be degraded if the ground terminal is used against Invivo’s
intended use.
CAUTION: Avoid use of electrical extension cords or Multiple Portable Socket Outlets which may
create a safety hazard by compromising the grounding integrity of the Precess MRI
Patient Monitoring System.
If longer distances are required, only use approved AC electrical extension cord, REF
989803168221 (25 ft jumper cord). Avoid use of extension cords or multiple portable
socket outlets, which may create a safety hazard by compromising the grounding
integrity of the MRI Patient Monitoring System.
WARNING: Cover the unused output with the Shield Cap in order to prevent noise artifacts from
appearing on the MR image.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
24
REF 989803173851 SECTION 4.0: SYSTEM POWER
4.2.2 CRD AC Power Adapter
CRD AC Power Adapter Kit REF 453564123631
Or individually
AC Power Adapter REF 453563464761
Power Adapter Cable REF 453564109681
WARNING: Do not use the CRD inside the MR system room. The device is magnetic and will be
pulled into the MR system. Never take the CRD into the MR system room.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
25
REF 989803173851 SECTION 4.0: SYSTEM POWER
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
26
5.0—SYSTEM SETUP
3160 Monitor Overall Block Diagram
5.1 CART
This section provides instructions regarding the installation of the Precess MRI Patient Monitoring
System. Observe the following warnings, cautions and notes when installing, setting up, and using the
Precess MRI Patient Monitoring System.
Observe the following warnings, cautions, notes, and instructions when installing, setting up, and
using the CART configuration for the Precess MRI Patient Monitoring System.
WARNING: Do not use the Precess MRI Patient Monitoring System in the presence of flammable
anesthetics.
Always verify proper communication of the Precess with the corresponding CRD (if
applicable) prior to patient use.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
27
REF 989803173851 SECTION 5.0: SYSTEM SETUP
CAUTION: Avoid the use of cellular phones or other radio‐frequency transmitters in the proximity of
an operating Precess MRI Patient Monitoring System. A minor but noticeable degradation
in the Wireless ECG and Wireless SpO2 radio communications will occur in the presence of
high powered radios.
Where the integrity of the external protective conductor in the installation or its
arrangement is in doubt, the system shall be operated from batteries.
WARNING: The Precess MRI Patient Monitoring System CART can be used inside the MR
system room in a location at or outside the 5,000 (5,000 or less) Gauss
(0.15T) field line of the MR system, as measured from the center line of the
MR bore. Failure to properly place the Precess and its accessories in the MR
system room will result in system or accessory failure, and possible patient
or user injury.
Always secure the CARTs wheel locks when the unit is placed within
the MR system room.
CAUTION: If the Precess MRI Patient Monitoring System Cart rolls to the face of the MR system
due to magnetically induced pull force, DO NOT ATTEMPT TO DISLODGE THE PRECESS
BY PULLING FROM THE HANDLE AT THE TOP OF THE CART DISPLAY. Dislodge the
Precess by gently pulling from the base of the system at its lowest point. This will
prevent the base of the unit from experiencing higher MR pull forces in the vertical
direction.
Field strength variations in a particular MR system room (which may be due to active
shielding technology, manufacturer variability, future enhancements, etc) can make
distinguishing the 5,000 Gauss level (as measured from the center line of the MR bore)
difficult. These variations may require moving the CART away from the MR system if
system abnormalities or malfunctions are observed. Prior to clinical use, ensure that
the allowable distance of the Precess components from the MR system is maintained
for proper operation.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
28
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.1.1 Initial Power Up
Complete the following actions to install the CART:
Step Action
1. Install the batteries into the CART.
2. Attach the AC Power Cord to the AC Input of the AC Power Converter.
3. Position the Cart within the parameters specified (in the warnings and cautions, above) and
then lock the wheels.
4. Plug the AC Power Cord into the AC outlet.
5. Turn ON the power switch located on the lower left side of the CART Display.
6. Verify successful boot up of the system.
Note: Complete system test will be in Section 6 of this manual.
5.1.2 CART SERVICE(BIO‐MED) Feature
Selecting the SERVICE(BIO‐MED) option from the SETUPS menu will bring up the CART SERVICE(BIO‐
MED) Menu. The CART SERVICE(BIO‐MED) Menu provides the operator with the ability to identify
the Software Revision level, place the system into a Simulation Mode (used for
training/demonstration purposes only), perform NIBP tests, calibrate the O2 cell (if available),
calibrate NIBP and adjust the configuration of the system.
CART SERVICE(BIO‐MED) Menu
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
29
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.1.2.1 S/W REV
Selecting this menu item brings up another window which contains detailed information about
the operating software of the CART. This Software Revision Screen contains the revision level
and date of build along with other technical information concerning the CART software. To exit
this window, select the OK button on the window or the NORMAL SCREEN button on the
monitor front panel.
Note: The contents of the Software Revision Screen will vary depending on the options and latest
software/upgrade installed in the monitor.
Sample of CART Software Revision Screen
5.2.2.2 SIMULATION MODE
This menu option allows the operator to turn the Simulation Mode ON. Selecting this menu
option will first bring up a YES/NO selection screen to ensure that this menu was not selected by
accident. When YES is selected, the monitor enters the Simulation Mode of operation. While in
the Simulation Mode the displayed patient information is computer generated and not actual
patient determinations. As a safety feature, while in the Simulation Mode the message
“SIMULATION” is displayed in the center of the screen and, when printing any strip or chart,
“SIMULATION” will also appear on the printout. To exit the Simulation Mode, the monitor must
be powered OFF.
WARNING: The Simulation Mode will display real‐looking waveforms which are computer
generated. The monitor will not monitor patients while in the Simulation Mode. To
exit the Simulation Mode, the monitor must be powered OFF
Do not activate the Simulation Mode with the monitor attached to a patient.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
30
REF 989803173851 SECTION 5.0: SYSTEM SETUP
CART SIMULATION MODE YES/NO Screen
Note: The contents of the SIMULATION MODE screen will vary depending on the options installed
or parameters that are turned on in the CART.
Sample of the CARTs SIMULATION Screen
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
31
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.2.2.3 NIBP TESTS
Selecting this menu option will bring up the CART NIBP TESTS Menu.
NIBP TESTS Menu via the CART
The following options are provided in this menu:
CALIBRATE (Available via the CART ONLY). Selecting this menu option will display the NIBP
CAL window. This window can display Offset Pressure (OFFSET PRESS) and Actual Pressure
(PRESS READING) values in the CART NIBP CAL Screen. When the NIBP CAL window is
displayed, the dump valve is closed so that the window may be used in a manometer
capacity. This window is used to verify and calibrate the internal NIBP primary and secondary
transducers. To display these readings, highlight the CALIBRATE menu option and press the
Rotary Knob; to exit this screen, press the Rotary Knob a second time.
CART NIBP CAL Screen
WARNING: NEVER initiate a Leak Test with an NIBP cuff attached to a patient. Continuous cuff
pressure could lead to patient injury.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
32
REF 989803173851 SECTION 5.0: SYSTEM SETUP
LEAK TEST. Selecting this menu option will display the NIBP LEAK TEST Screen with the Peak
(beginning) Pressure and Final (current) Pressure displayed, along with the number of Passes
and Failures of the test, to determine the leak rate of the NIBP system. Running the LEAK
TEST is explained in the NIBP portion of Section 6.
.
CART NIBP LEAK TEST Screen
RETURN. Selecting this menu option returns the monitor to the Normal Screen
5.1.2.4 GAS CAL (Agents Option Only).
Selecting this menu option will bring up the CART GAS CAL Menu.
CART GAS CAL Menu
The following menu options are provided in this menu:
ZERO CAL. Selecting this menu option will cause the monitor to perform a Zero Cal of the
EtCO2 or Agent System.
SPAN CAL. When the Agents or Low‐Flow ETCO2 option is installed, selecting this menu
option will bring up a Password Entry Box requiring a five (5) digit service code to access the
CART SPAN CAL Menu.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
33
REF 989803173851 SECTION 5.0: SYSTEM SETUP
Note: The SPAN CAL menu is for Production and Repair Center Use ONLY. This is not for Field
repair.
O2 CAL (Agents Option Only). Selecting this menu option will cause the monitor to perform a
ten (10) second calibration of the O2 Sensor. (During calibration, the patient GAS Input Port
must not be connected to an oxygen source.)
A 10 second zero shall be required for the following reasons:
If the O2 concentration ever exceeds 103%;
If the O2 value remains above 22% for 12 hours.
Once the user confirms the O2 calibration, a dialog box shall be displayed indicating that the
Agents parameter must be on for a minimum of 10 minutes (only if the parameter has not
been turned on yet).
This dialog box appears reminding that there should not be any connection to the sample line
and that the unit needs to sample room air for 10 seconds.
During O2 calibration, the message ‘READJUSTING O2 ZERO’ shall be displayed at the top
center of the display.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
34
REF 989803173851 SECTION 5.0: SYSTEM SETUP
GAS MONITOR (Agents Option Only). Selecting this menu option brings up the CART Gas
Monitor Screen.
Note: This box contains Gas Sensor Calibration characteristics related to Anesthetic Agents and
Gases, for use by Engineering ONLY in developing and testing agent‐related software and
hardware.
CART GAS MONITOR Screen
RETURN. Selecting this menu option returns the monitor to the Normal Screen.
5.1.2.5 MONITOR CAL (Agents Option Only‐Production and Engineering
purposes ONLY).
Selecting this menu option will first bring up a YES/NO selection screen to ensure that this menu
was not selected by accident. When YES is selected a second screen with Calibration Information
on various operational aspects of the monitor appears. If this display should be selected, exit by
turning the monitor off. It is important to note that if the Escape option is selected, the monitor
will return control of the monitor to the operator but the Calibration Screen will remain on the
display; to remove the Calibration Screen turn the monitor off.
CART MONITOR CAL YES/NO Screen
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
35
REF 989803173851 SECTION 5.0: SYSTEM SETUP
CART MONITOR CAL Information Screen
5.1.2.6 SERVICE UTILITES
(For Engineering and Design use ONLY—Password Protected)
Selecting this menu option will bring up the CART SERVICE UTILITES menu.
CART SERVICE UTILITIES Log In Screen
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
36
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.1.2.7 SYSTEM CONFIG
The SYSTEM CONFIG menu shall be displayed by selecting the SYSTEM CONFIG menu option. The
SYSTEM CONFIG menu shall provide a facility through which the various options of the monitor
can be enabled, disabled, or configured. For options that are password protected, selecting the
option shall display a warning message accompanied with a means of providing a password. The
SYSTEM CONFIG settings of the DCUs shall be synchronized with those of the WPU.
Note: The password is for Philips personnel only and can be obtained by calling Technical Support.
CART SYSTEM CONFIG Screen
In both the CART and CRD, the SYSTEM CONFIG menu is used to describe the hardware,
software, and features that are available in the system. The items in this menu are set to specific
settings to reflect the unit’s capabilities prior to a unit being used by a customer. This menu may
be displayed and items listed in it changed on each unit. The settings on this menu are used by
each system to determine the unit’s behavior in various ways. For example, the CART and CRD
user interfaces will not allow a vital sign to be turned on if the system configuration information
states that the hardware to support that vital sign is not available in the system.
Because the CART and CRD are distinctly different in the hardware that is available and the
capabilities that each unit has, certain items on this menu are applicable to only either the CART
or the CRD. For example, the PRINTER item is applicable to only the CRD, since only a CRD is
capable of possessing strip chart recorder hardware.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
37
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.2 CRD
5.2.1 Initial Power Up
Observe the following instructions to operate the CRD using AC power.
Step Action
1. Install Antenna.
2. Position the CRD and AC power adapter in the MR control room or holding area, near an
approved AC outlet, and then connect to that AC outlet.
3. Attach the input cable from the AC power adapter to the rear of the CRD.
4. Turn ON the power switch located on the lower left side of the CRD Display.
5. Verify successful boot up of the CRD.
Note: Complete system test will be in Section 6 of this manual.
Additional Installation Options
Only the CRD is configured with input/output ports that permit connections to external equipment:
Connection to facility information systems.
5.2.2 CRD SERVICE(BIO‐MED) Feature.
Selecting the SERVICE(BIO‐MED) option from the SETUPS menu will bring up the CRD SERVICE(BIO‐
MED) Menu. The CRD SERVICE(BIO‐MED) Menu provides the operator with the ability to identify
the Software Revision level, place the system into a Simulation Mode (used for
training/demonstration purposes only), perform NIBP tests, calibrate the O2 cell (if available), and
adjust the configuration of the system.
CRD SERVICE(BIO‐MED) Menu
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
38
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.2.2.1 S/W REV
Selecting this menu item brings up another window which contains detailed information about
the operating software of the CRD. This Software Revision Screen contains the revision level and
date of build along with other technical information concerning the CRD software. To exit this
window, select the OK button on the window or the NORMAL SCREEN button on the monitor
front panel.
Note: The contents of the Software Revision Screen will vary depending on the options and
latest software/upgrade installed in the monitor.
Sample of CRD Software Revision Screen when not communicating with a CART
Sample of CRD Software Revision Screen while communicating with the CART
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
39
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.2.2.2 SIMULATION MODE
Note: The SIMULATION waveforms and numerics are generated from the CART and will only be
displayed if the CRD is communicating with a CART.
This menu option allows the operator to turn the Simulation Mode ON. Selecting this menu
option will first bring up a YES/NO selection screen to ensure that this menu was not selected by
accident. When YES is selected, the monitor enters the Simulation Mode of operation. While in
the Simulation Mode the displayed patient information is computer generated and not actual
patient determinations. As a safety feature, while in the Simulation Mode the message
“SIMULATION” is displayed in the center of the screen and, when printing any strip or chart,
“SIMULATION” will also appear on the printout. To exit the Simulation Mode, the monitor must
be powered OFF.
WARNING: The Simulation Mode will display real‐looking waveforms which are computer
generated. The monitor will not monitor patients while in the Simulation Mode. To
exit the Simulation Mode, the monitor must be powered OFF
Do not activate the Simulation Mode with the monitor attached to a patient.
CRD SIMULATION MODE YES/NO Screen
Note: The contents of the SIMULATION MODE screen will vary depending on the parameters
that are turned on in the CRD.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
40
REF 989803173851 SECTION 5.0: SYSTEM SETUP
Sample of the CRDs SIMULATION Screen
Sample of SIMULATION Strip Chart Recording
5.2.2.3 NIBP TESTS
Selecting this menu option will bring up the CART NIBP TESTS Menu.
NIBP TESTS Menu via the CRD
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
41
REF 989803173851 SECTION 5.0: SYSTEM SETUP
The following options are provided in this menu:
WARNING: NEVER initiate a Leak Test with an NIBP cuff attached to a patient. Continuous cuff
pressure could lead to patient injury.
LEAK TEST. Selecting this menu option will display the NIBP LEAK TEST Screen with the Peak
(beginning) Pressure and Final (current) Pressure displayed, along with the number of Passes and
Failures of the test, to determine the leak rate of the NIBP system. To begin this test, highlight
the LEAK TEST menu option and press the Rotary Knob; to stop a test in progress, press the
Rotary Knob a second time
.
CRD NIBP LEAK TEST Screen
RETURN. Selecting this menu option returns the monitor to the Normal Screen
5.2.2.4 GAS CAL (Agents Option Only).
Selecting this menu option will bring up the CART GAS CAL Menu.
CRD GAS CAL Menu
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
42
REF 989803173851 SECTION 5.0: SYSTEM SETUP
The following menu options are provided in this menu:
ZERO CAL. Selecting this menu option will cause the monitor to perform a Zero Cal of the EtCO2
or Agent System.
O2 CAL (Agents Option Only). Selecting this menu option will cause the monitor to perform a ten
(10) second calibration of the O2 Sensor. (During calibration, the patient GAS Input Port must not
be connected to an oxygen source.)
A 10 second zero shall be required for the following reasons:
If the O2 concentration ever exceeds 103%;
If the O2 value remains above 22% for 12 hours.
Once the user confirms the O2 calibration, a dialog box shall be displayed indicating that the
Agents parameter must be on for a minimum of 10 minutes (only if the parameter has not been
turned on yet).
This dialog box appears reminding that there should not be any connection to the sample line
and that the unit needs to sample room air for 10 seconds.
During O2 calibration, the message ‘READJUSTING O2 ZERO’ shall be displayed at the top center
of the display.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
43
REF 989803173851 SECTION 5.0: SYSTEM SETUP
5.1.2.6 SERVICE UTILITES
(For Engineering and Design use ONLY—Password Protected)
Selecting this menu option will bring up the CART SERVICE UTILITES menu.
CRD SERVICE UTILITIES Log In Screen
5.1.2.7 SYSTEM CONFIG
The SYSTEM CONFIG menu shall be displayed by selecting the SYSTEM CONFIG menu option. The
SYSTEM CONFIG menu shall provide a facility through which the various options of the monitor
can be enabled, disabled, or configured. For options that are password protected, selecting the
option shall display a warning message accompanied with a means of providing a password. The
SYSTEM CONFIG settings of the DCUs shall be synchronized with those of the WPU.
Note: The password is for Philips personnel only and can be obtained by calling Technical Support.
CRD SYSTEM CONFIG Screen
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
44
REF 989803173851 SECTION 5.0: SYSTEM SETUP
In both the CART and CRD, the SYSTEM CONFIG menu is used to describe the hardware,
software, and features that are available in the system. The items in this menu are set to specific
settings to reflect the unit’s capabilities prior to a unit being used by a customer. This menu may
be displayed and items listed in it changed on each unit. The settings on this menu are used by
each system to determine the unit’s behavior in various ways. For example, the CART and CRD
user interfaces will not allow a vital sign to be turned on if the system configuration information
states that the hardware to support that vital sign is not available in the system.
Because the CART and CRD are distinctly different in the hardware that is available and the
capabilities that each unit has, certain items on this menu are applicable to only either the CART
or the CRD. For example, the PRINTER item is applicable to only the CRD, since only a CRD is
capable of possessing strip
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
45
REF 989803173851 SECTION 5.0: SYSTEM SETUP
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
46
6.0—TEST AND INSPECTION
This section details test and inspection instructions to verify system operations.
6.1 When to Test
Service Event Test Required
(When performing… …Complete these tests)
Installation Perform Visual Inspection and Power On
Perform Visual Inspection, Power On, and Performance Assurance
Preventative Maintenance
Tests
Perform Visual Inspection, Power On, and Performance Assurance
All Repairs
Tests
Perform Visual Inspection, Power On, and Performance Assurance
Upgrade
Tests
Perform Visual Inspection, Power On, and Performance Assurance
All other service events
Tests
6.2 Test and Inspection Matrix Checklist
Test or Inspection
Test Block Expected Test Results Record the Results *
to be Performed
Inspect the unit and cables for If NO damage, then
Visual V:P or V:F
damage. Visual test passed.
Expected answer is
Perform Power On Test in (Part “yes”.
Power On I, below). Do all the steps in PO:P or PO:F
Part I pass? If so, Power On test
passed.
No safety test is required on
Safety N/A S:N/A
this system.
*Where P = Pass, F = Fail, and N/A = Not Applicable
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
47
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
6.3 Performance Assurance Test Checklist
Performance Assurance
Record the Results
Test or Inspection to be Performed Expected Test Results
(P=pass and F=fail)
Do all the steps in 1.0 pass?
PA1:P: or PA1:F:
1.0 Perform INITIAL SETUP The expected answer is “yes”.
___________
If so, Initial Setup is passed.
Do all the steps in 2.0 pass?
PA2:P: or PA2:F:
2.0 Perform POWER ON Verification Expected answer is “yes”.
___________
If so, Power ON is passed.
Do all the steps in 3.0 pass?
PA3:P: or PA3:F:
3.0 Perform COMMUNICATION Verification. Expected answer is “yes”.
________
If so, Communication is passed.
Do all the steps in 4.0 pass?
PA4:P: or PA4:F:
4.0 Perform KEYPAD Verification. Expected answer is “yes”.
________
If so, Keypad is passed.
Do all the steps in 5.0 pass?
PA5:P: or PA5:F:
5.0 Perform SOUND ADJUST Verification. Expected answer is “yes”.
________
If so, Sound Adjust Verification is passed.
Do all the steps in 6.0 pass?
PA6:P: or PA6:F:
6.0 Perform TIME and DATE Verification. Expected answer is “yes”.
________
If so, TIME & DATE Verification is passed.
Do all the steps in 7.0 pass?
PA7:P: or PA7:F:
7.0 Perform WECG COMM Verification. Expected answer is “yes”.
________
If so, WECG COMM Verification is passed.
Do all the steps in 8.0 pass?
PA8:P: or PA8:F:
8.0 Perform WSPO2 COMM Verification. Expected answer is “yes”.
________
If so, WSPO2 COMM Verification is passed.
Do all the steps in 9.0 pass? PA9:P: or PA9:F:
9.0 Perform PRINTER Verification.
Expected answer is “yes”. ________
If Printer option is not installed, do not perform.
If so, Printer is passed. or N/A=not performed
PA10:P: or PA10:F:
Do all the steps in 10.0 pass?
________
10.0 Perform NIBP Verification. Expected answer is “yes”.
PRI reading______
If so, NIBP Verification is passed.
SEC reading______
Do all the steps in 11.0 pass? PA11:P: or PA11:F:
11.0 Perform IBP Verification.
Expected answer is “yes”. ________
If IBP option is not installed, do not perform.
If so, IBP Verification is passed. or N/A=not performed
PA12:P: or PA12:F:
Do all the steps in 12.0 pass? ________
12.0 Perform AGENTS Verification.
Expected answer is “yes”. or N/A=not performed
If AGENTS option is not installed, do not perform.
If so, AGENTS Verification is passed. CO2 reading______
N2O reading______
PA13:P: or PA13:F:
Do all the steps in 13.0 pass? ________
13.0 Perform ETCO2 Verification.
Expected answer is “yes”. or N/A=not performed
If ETCO2 option is not installed, do not perform.
If so ETCO2 Verification is passed. CO2 reading______
N2O reading______
Do all the steps in 14.0 pass? PA14:P: or PA14:F:
14.0 Perform RESP Verification.
Expected answer is “yes”. ________
If Respiration option is not installed, do not perform.
If so, Respiration Verification is passed. or N/A=not performed
Do all the steps in 15.0 pass? PA15:P: or PA15:F:
15. 0 Perform TEMP Verification.
Expected answer is “yes”. ________
If Temperature option is not installed, do not perform.
If so, Temperature Verification is passed. or N/A=not performed
16.0 Perform GATING Test. Do all the steps in 16.0 pass? PA16:P: or PA16:F:
If a Gating cable is not available from customer, option was Expected answer is “yes”. ________
not installed, do not perform. If so, GATING Test is passed. or N/A=not performed
Do all the steps in 17.0 pass?
PA17:P: or PA17:F:
17.0 Perform RF Test. Expected answer is “yes”.
________
If so, RF Test is passed.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
48
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
6.4 Recommended Frequency of Testing
Suggested Testing Timetable
Test Frequency
Recommended once per year (or as specified by local
Performance Assurance.
laws) and after any type of repair of the unit.
Regular Preventative Maintenance. Recommended once per year.
6.5 Preventative Maintenance
Preventive Perform the blocks below as part of preventative maintenance:
Maintenance:
Visual Inspection
Power On
Performance Assurance Test
6.6 Test Process Description and Requirements
The system under test must be handled in compliance with ESD procedures and as detailed
below.
Test Equipment Requirements:
1. Patient Simulator (Metron PS‐416M or MedSim 300 model) or equivalent (with
ECG/Simulator Patient ECG Cable)
2. Invasive Pressure Simulator capable of producing static pressure values of 0, 40, 100, 200 &
250mmhg (with IBP/Simulator Adapter cable)
3. TSI Model 4140 Flowmeter (453564178121 or 453563230731), or OMEGA FL‐211
Flowmeter or equivalent (with appropriate tubing: SBR, 0.250”x 0.125”x 0.0625”; quantity
2 feet)
4. Baumanometer (Manometer) or equivalent with Invivo adapter (connector with 1/8 Hose x
5/17‐24 fitting)
5. Patient Simulator (Metron PS‐416M or MedSim 300 model) or equivalent (with
ECG/Simulator Patient ECG Cable)
6. Digital Multimeter (DMM) (5.5 digit accuracy or better)
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
49
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
Additional Test Equipment (required ONLY for Bench Repair):
1. 20 MHz Dual Channel Oscilloscope
2. RF Test Station
3. Agent Calibration Station (If Agents option is installed)
Required Accessories:
The following accessories are necessary to perform this Test and Inspection procedure. In most
cases the customer’s accessories are preferable and should be used in testing and verifying the
system. However, the following is a list of the recommended part numbers.
Parameter Description (Invivo REF) Commercial REF
ECG Standard ECG lead/cable set (9224) 989803152301)
Quick Connect SPO2 Cable 989803161991
SPO2
Adult Quick Connect Clip Sensor 989803166531
Adult Hose 989803169411
Adult Cuff 989803169451
NIBP
Neonatal Hose 989803169421
Neonatal cuff (size #3) 989803170401
TEMP Probe, Fiber Optic Surface Temp (9320) 989803152801
RESP Chest Pneumograph sensor (bellows)(94023) 989803152791
AGENTS CAL GAS, AEROSOL CO‐2 (9010F) 989803152641
ETCO2 CANNULA, DISP, ADULT (9012) 989803152561
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
50
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
6.7 Test Process
Test Part I.0: Initial Setup
1.1 Insert 2 batteries (REF 989803169491) into the CART.
1.2 Connect the CART to normal AC power and verify the Power Indicator LED on the AC Power
Converter mounted under the CART is illuminated GREEN.
1.3 If applicable, connect AC Adapter Kit (REF 453564123631) to the CRD. Connect the AC Adapter
to normal AC power. Verify that the LED on the keypad is illuminated GREEN and is blinking
slowly.
Note: ETCO2 or AGENTS option must remain active during test. Interruptions should not occur
from power up to ETCO2 or AGENTS testing so that temperature is at optimal range. Verify
the unit does not display ETCO2 HW FAIL after the ETCO2 WARMUP message disappears at
the top center of the CART display.
1.4 CART configured with a GAS parameter, if not proceed to Test Part 2.0:
1.4.a ETCO2 OPTION ONLY: Attach the Low Flow ETCO2 Water Trap (clear with a blue band) to
the PCU and the blue sample line only to the water trap.
(REF 94020) (REF 94021)
LOW‐FLOW ETCO2 Water Trap and Sample Line
Note: Even though the AGENTS option can also monitor ETCO2, only the CLEAR Water Trap and
CLEAR Sample Line can be used.
LOW‐FLOW ETCO2 and AGENTS accessories are not interchangeable.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
51
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
1.4.b AGENTS OPTION ONLY: Attach the Clear Agents Water Trap to the PCU and the clear
sample line only to the water trap. Verify that an O2 Cell is also installed. (See Appendix
C for O2 Cell removal and replacement).
(REF 94012) (REF 94018)
AGENTS Water Trap and Sample Line
Typical Pneumatic Circuit for AGENTS or LOW‐FLOW ETCO2
1. Water Trap 3. Sample Line 5. Nasal Cannula
2. Water Trap port fitting 4. Patient Airway Adapter
Note: All fittings are the Luer Lock type.
Do not connect items 4 or 5 above until the message “CO2 WARMING UP” is no longer
displayed.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
52
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
Test Part 2.0: Power ON Test
2.1 Turn the CART power switch ON and verify the unit has successfully powered up and the CART
Power Indicator LED (located on the keypad) is now SOLID.
LED Indication System Status
Color Solid Power Status Power Switch
Not on external power
No Color
N/A (batteries may or may not be OFF
(Not lit)
inserted)
On battery power, and
Red Yes battery voltage falls below ON
14.2±0.2V.
CART Keypad Power LED Indications
2.2 If applicable, turn the CRD power switch ON and verify the unit has successfully powered up
and the CRD Power Indicator LED (located on the keypad) is now ON.
Note: “Blinking Slow” is defined as blinking once every 2.5 seconds.
“Blinking Fast” is defined as blinking once every 0.6 seconds.
For states when the power switch is ON, the CRD communication status will be valid when
the CRD has completed its power on sequence.
LED Indication System Status
Power CRD Communication
Color Solid/Blinking Power Status
Switch Status
No Color Not on external
N/A OFF Not applicable
(Not lit) power
Green Blinking Slow On external power OFF Not applicable
No communication
Green Blinking Fast On external power ON
with the CART
Communication is good
Green Solid On external power ON
with the CART
CRD Power/Communication LED Indications
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
53
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
Note: After power up verify that the CART and CRD are set to the same network assignment for
each unit. Below are the numbers and corresponding colors/shapes for the 5 available
networks.
Yellow Green Teal White Magenta
2.3 Insert 9065 batteries into the WECG and WSPO2 modules. Verify both the Power Indicator
LEDs on the modules are illuminated GREEN and not blinking. Also verify that the modules are
set to the correct network assignment as the CART and CRD.
Test Part 3.0: Communication Verification and Power Icon Check
3.1 With the CART and CRD powered up and booted on AC power with batteries installed (CART
only), verify communication (COMM) between the CART, CRD, and the WECG and WSPO2
remotes (icons shown in Row 1 of Table 2 and Table 3 below).
3.2 With the system setup as in step 3.1, verify power icons between the CART, CRD, and the WECG
and WSPO2 remotes (icons shown in row 2 of Table 1, below).
3.3. With the system setup as in step 3.1, remove AC power from the CART so that the CART is
running on DC power only. Verify power icons between the CART, CRD, and the WECG and
WSPO2 remotes (as shown in row 1 of Table 1, below).
3.4 Reconnect AC power to the CART and remove the batteries so that the CART is running on AC
power ONLY. Verify power icons between the CART, CRD, and the WECG and WSPO2 remotes
(as shown in row 3 of Table 1, below).
3.5 Skip this step if no CRD. Return power and communication as in step 3.1. Turn the CRD off and
verify COMM is lost between the CART and CRD (CRD status icon shown in Table 2 Row 2).
Remove the batteries from the WECG and WSPO2 modules. Verify Comm is lost between the
CART and the Wireless Modules (WECG and WSPO2 status icons shown in Row 2 of Table 2
below).
3.6 Skip this step if no CRD. Return power and communication as in step 3.1. Turn the CART off
and verify COMM is lost between the CART, CRD, and the WIRELESS modules. Verify the CART
and Wireless Modules status icons reflect no COMM (as shown in Row 2 of Table 3 below).
Return power as in step 3.1.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
54
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
Table 1
System Icons
Conditions
Row Displayed on Displayed on Displayed on CART Displayed on CART
Tested
CRD CART & CRD & CRD
DC Power
1 (Batteries
Only)
AC Power
w/
2
Batteries
Installed
AC Power
w/o
3
Batteries
Installed
Table 1: System Icons
Table 2
Conditions CART Icons
Row
Tested CRD Status ECG Status SPO2 Status
1 COMM
2 No COMM
Table 2: CART Icons
Table 3
Conditions CRD Icons
Row
Tested CART Status ECG Status SPO2 Status
1 COMM
2 No COMM
Table 3: CRD Icons
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
55
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
3.7 Skip this step if no CRD. If more than one (1) CRD is available, check dual communication
between the CART and CRDs. Return power and communication as in step 3.1. Press the NIBP
START/STOP button on the CRD and verify that the CART NIBP starts pumping. Press the button
again to stop the pump. Repeat with the 2nd CRD. Next, turn any available parameter not
already displayed on the CRD display. Verify that the parameter automatically appears on the
2nd CRD. On the 2nd CRD, turn that same parameter back off and verify that that parameter on
the 1st CRD is now no longer is displayed.
3.8 Referring to step 1.4, if the Agents or ETCO2 parameter is not displayed after power up, enter
the SETUPS / PARAMETER SELECTION menu to turn AGENTS or ETCO2 ON. Verify that the
“WARMING UP” message is displayed at the top center of the CART display.
Note: ETCO2 or AGENTS option must remain active during test. Interruptions should not occur
from power up to ETCO2 or AGENTS testing so that temperature is at optimal range. Verify
the unit does not display ETCO2 HW FAIL after the ETCO2 WARMUP message disappears at
the top center of the CART display.
Test Part 4.0: Keypad Verification
During the course of the T & I, verify the function of the keypad.
Test Part 5.0: Sound Verification
5.1 Press the SETUP function key to open the SETUPS menu and select SOUNDADJUST, then select
ALARM VOLUME. Set the ALARM VOLUME level to 1 and verify an audible tone is produced.
Set the ALARM VOLUME level to 10 and verify a loud tone free of speaker crackling and
excessive distortion. Set the ALARM VOLUME level to 4.
5.2 Repeat for PULSE VOLUME and CLICK TONE VOLUME. Select RETURN when finished.
Test Part 6.0: Time and Date Verification
6.1 Return to the SETUPS menu, select SET TIME and verify current time and date.
Test Part 7.0: WECG Verification
7.1 With 9065 battery inserted into the WECG module and communicating to the 3160 system,
connect the ECG cable to the WECG module. Connect the ECG leads to the Patient Simulator as
indicated in Table 4 below (as a reference Table 5 illustrates the ECG Leads to Lead
Wires/Colors Scheme):
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
56
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
Table 4
Lead Color Code from ECG Cable Patient Simulator Terminals
GREEN RL
WHITE RA
BLACK LA
RED LL
Patient Simulator ECG Lead Attachments
Table 5
ECG Trace A/B Leads(s) Patient Simulator Terminals
I RA, LA
II RA, LL
III LA, LL
Patient Simulator Terminal Selections
7.2 Set the Patient Simulator to output a 1 mV QRS pulse at 60BPM (NORMAL SINUS mode)
7.3 Within the ECG menu:
Set TRACE A LEAD to I
Set TRACE B LEAD to OFF
Set SCALE of 10 mm/mV
FILTER MODE set to MON
Set HR TONE SOURCE and select QRS
7.4 With the SETUPS Menu, verify PATIENT is set to ADULT.
7.5 Verify the following:
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 60 BPM 1BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
7.6 Disconnect ECG cable from the module and simulator.
Test Part 8.0: WSPO2 Verification
8.1 With battery inserted into the WSPO2 module and communicating to the 3160 system, connect
a SPO2 probe to the module.
8.2 Verify PROBE OFF is displayed in the SPO2 box when there is no finger inserted into the probe.
8.3 Within the SPO2 menu press the rotary/selector knob and select HR TONE SOURCE. Within the
HR TONE SOURCE select SPO2.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
57
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
8.4 Place tip of operator’s finger inside probe.
8.5 Verify the following:
A SPO2 (pulse) waveform with each heat rate count.
A reasonable SPO2 number (95 to 100%) displayed inside the SPO2 label at the right edge of
the screen.
A smooth waveform without steps.
8.7 Disconnect the SPO2 probe from the WSPO2 module.
Test Part 9.0: PRINTER Verification (CRD)
(N/A if CRD is not available or the CRD does not have the Printer option installed)
CRD REMOTE PRINT ICONS
Icon
Meaning Icon displayed on….
Displayed
CART communicating with CRD with a CART
printer installed—printer is ready
Remote printing is currently in progress. CART and CRD
A print cycle countdown (in seconds) (Icon will only appear
will be displayed while the printer is on the CRD during the
running. Cycle is approx. 30 seconds. print cycle)
Printer not installed in the CRD or the CART
CART is not communicating with a CRD.
Printer is unable to print—printer door
open or out of paper. If a print CART
command is sent while in this state, the
icon shown will blink approx. 5 times.
Perform the following procedure to verify proper operation of the CRDs printing system:
9.1 Connect an ECG Patient Simulator to the ECG input on the PCU front panel. Set the Patient
Simulator to output a 1 mV square wave at 2 Hz.
9.2 Setup the ECG as follows:
TRACE A LEAD to II
TRACE B LEAD to OFF
SCALE of 10 mm/mV
FILTER MODE set to MON
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
58
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
9.3 Press the RECORDER SETUP button and setup the Recorder as follows:
TRACE 1 to ECG I
TRACE 2 to OFF
SWEEP SPEED of 25 mm/s
9.4 Press the PRINT button, wait five (5) seconds and press the PRINT button a second time.
9.5 LOW SPEED VERIFICIATION
The paper comes out smoothly with all printing performed clearly
The printout has a deflection of 10 mm (2 blocks) 1 mm
The LO speed printout is a full cycle of 15 mm (2.5 blocks) 1 mm
9.6 Press the RECORDER SETUP button and setup the Recorder as follows
Change the SWEEP SPEED to 50 mm/s
9.7 Press the PRINT button, wait five (5) seconds and press the PRINT button a second time.
9.8 HIGH SPEED VERIFICIATION
The paper comes out smoothly with all printing performed clearly
The HI speed printout is a full cycle of 30 mm (5 blocks) 1 mm
Test Part 10.0: NIBP Verification
Note: A number of tests in this section utilize the NIBP CAL window. Due to a hardware timer,
the NIBP CAL window should not be displayed for a period longer than 3 minutes at a
time. The NIBP CAL window can be closed via any means within this 3 minute period to
reset the timer. In the event the NIBP CAL window is displayed for longer than 3 minutes,
the NIBP hardware timer will disable the NIBP parameter and the CART will need to be
power cycled to reset the NIBP hardware. Verify that all parameters from the initial setup
(step 1.0) are turned back on.
10.1 PNEUMATIC LEAK TEST
10.1.a LEAK TEST Setup
Within the SETUPS menu, set PATIENT to ADULT.
Connect an Adult cuff and hose to the 3160 NIBP ports and tightly wrap the cuff around a fixed
object, approx. 6” in diameter.
Within the SETUPS menu, select SERVICE(BIO‐MED). Next, select NIBP TESTS and then select
LEAK TEST. The pump will start automatically and cycle approximately every 30 seconds.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
59
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
10.1.b LEAK TEST Verification
Verify that at the end of each leak test cycle (a minimum of two cycles), the difference between
PEAK and FINAL is 10. The PNEUMATIC LEAK test must be performed for both High (1st row)
and Low (2nd row) pressure leaks.
Press the selector knob to exit the LEAK TEST cycle and disconnect the leak hose.
10.2 NIBP OFFSET
10.2.a NIBP OFFSET Setup
Press the SETUPS button Select SERVICE(BIO‐MED), then NIBP TESTS, then CALIBRATE.
10.2.b NIBP OFFSET Verification
Without any pressure applied, verify the offset reading on the primary (PRI) and secondary (SEC)
is within 10±2 in the NIBP CAL window.
Record the PRI and SEC offset readings in acceptance column.
10.3 PRI & SEC CALIBRATION ACCURACY CHECK
10.3.a SEC CALIBRATION ACCURACY Setup
While still in the NIBP CAL window, connect a Manometer and hand bulb to the NIBP Pump
(right) port and close the valve on the Manometer hand bulb. Slowly increase the pressure until
the Manometer reads 250mmHg.
10.3.b SEC CALIBRATION ACCURACY Verification
Verify the PRESS READING of the SEC transducer reads 250 5mmHg.
10.3.c PRI CALIBRATION ACCURACY Setup
Close the NIBP CAL window by pressing the Rotary Knob. Open the valve on the Manometer
hand bulb.
Connect the Manometer to the NIBP Sense (left) port and close the valve on the Manometer
hand bulb. Display the NIBP CAL window once again. Slowly increase the pressure until the
Manometer reads 250mmHg.
10.3.d PRI CALIBRATION ACCURACY Verification
Verify the PRESS READING of the PRI transducer reads 250 5mmHg. Close the NIBP CAL
window and open the Manometer hand bulb valve.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
60
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
10.4 OVER PRESSURE‐‐ADULT
10.4.a ADULT OVER PRESSURE (SEC) Setup
Connect a Manometer and hand‐bulb to the NIBP Pump (right) port. Close the hand‐bulb valve.
Press the SETUP button. Within the SETUPS menu select the SERVICE(BIO‐MED) and then select
NIBP TEST. From the NIBP TEST select CALIBRATE and verify NIBP CAL window is displayed.
Squeeze the hand‐bulb until SEC: PRESS READING equals 295mmHg in the NIBP CAL window.
10.4.b ADULT OVER PRESSURE (SEC) Verification
Verify over‐pressure occurs (as indicated by pressure fall) at 295 4mmHg and “OVER PRES” is
displayed in the Error Message Display area. Press the STANDBY button, then press STANDBY
again to remove message.
10.4.c ADULT OVER PRESSURE (PRI) Setup
Switch/connect the Manometer to the NIBP Sense (left) port. Display the NIBP CAL window.
Close the hand‐bulb valve; squeeze the hand‐bulb until PRI: PRESS READING equals 285
4mmHg.
10.4.d ADULT OVER PRESSURE (PRI) Verification
Verify “OVER PRES” is displayed in the Error Message Display area. Press STANDBY, then press
STANDBY again to remove message. Note: Pressure will not fall during this test step.
10.5 OVER PRESSURE‐‐NEONATAL
10.5.a NEO OVER PRESSURE (SEC) Setup
Connect a Manometer and hand‐bulb to the NIBP Pump (right) port. Close the hand‐bulb valve.
Within the SETUPS menu change the PATIENT option from ADULT to NEO. Display the NIBP CAL
window. (NIBP CAL window must be displayed).
Squeeze the hand‐bulb until SEC: PRESS READING equals 150mmHg.
10.5.b NEO OVER PRESSURE (SEC) Verification
Verify over‐pressure occurs (as indicated by pressure fall) at 150 4mmHg and “OVER PRES” is
displayed in the Error Message Display area. Press the STANDBY button, then STANDBY again to
remove message. Open the Manometer hand‐bulb valve.
Repeat the above step to verify that if the pressure reading is >142 but <150mmHg, the “OVER
PRES” alarm will activate within 15 seconds. Open the Manometer hand‐bulb valve.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
61
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
10.5.c NEO OVER PRESSURE (PRI) Setup
Switch/connect the Manometer to the NIBP Sense (left) port. Display the NIBP CAL window.
Close the hand‐bulb valve; squeeze the hand‐bulb until PRI: PRESS READING equals 156
4mmHg.
10.5.d NEO OVER PRESSURE (PRI) Verification
Verify “OVER PRES” is displayed in the Error Message Display area. Press STANDBY, then press
STANDBY again to remove message. Note: Pressure will not fall during this test step.
Repeat the above step to verify that if the pressure reading is >142 but <150mmHg, the “OVER
PRES” alarm will activate within 15 seconds. Open the Manometer hand‐bulb valve.
10.6 ADULT VERIFICATION
10.6.a ADULT VERIFICATION Setup
Connect a hose and adult cuff to the NIBP ports and place cuff on arm. Within the SETUPS
menu set the PATIENT option to ADULT. Press the NIBP START/STOP function key
10.6.b ADULT VERIFICATION
Verify cuff inflates to approximately 170mmhg and the cuff deflates when a blood pressure
determination has been reached.
Verify those systolic, mean and diastolic pressure numerics are present in the NIBP menu.
Remove cuff from arm.
10.6.c ADULT DEAD MAN CUFF Setup
With the Adult cuff still connected; place cuff around a fixed object, approx. 6” in diameter arm.
Press the NIBP START/STOP function key.
10.6.d ADULT DEAD MAN Verification
Verify the unit displays a Zero reading at the end of the NIBP cycle. Disconnect the adult cuff.
10.7 NEONATAL VERIFICATION
10.7.a NEO VERIFICATION Setup
Connect a hose and neonate cuff to the NIBP ports and place cuff on finger. Within the SETUPS
menu set the PATIENT option to NEO. Press the NIBP START/STOP function key. Hold hand
with cuffed finger above shoulder height to insure measured blood pressure is below 100mmHg.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
62
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
10.7.b NEO VERIFICATION
Verify cuff inflates to approximately 130mmHg and the cuff deflates when a blood pressure
determination has been reached.
Verify that systolic, mean, and diastolic pressure numeric are present in the NIBP menu and
values are normal for the operator’s neo finger pressure. Remove cuff from finger.
10.7.c NEO DEAD MAN CUFF Setup
With the neo cuff still connected, placed cuff around fixed object, approx. 1” in diameter. Press
the NIBP START/STOP function key.
10.7.d NEO DEAD MAN Verification
Verify the unit displays a Zero reading at the end of the NIBP cycle. Disconnect the neo cuff.
Set the SETUPS/PATIENT option back to ADULT.
10.8 LEAK TIME‐OUT
10.8.a LEAK TIME‐OUT Setup
Remove any cuff connections. Turn the pump on with the NIBP START / STOP function key. The
NIBP Sense (left) port must remain open without any external connection while the pump runs
freely.
10.8.b LEAK LIME‐OUT Verification
Verify that the pump shuts off within 6 seconds 1.5 seconds and that the error message NOT
INFLATING is displayed in the NIBP menu. Set the SETUPS / PATIENT option to NEO.
Repeat test and verify that the pump shuts off within 6 seconds 1.5 seconds.
10.9 CALIBRATE ERROR
Note: The CART must NOT be in STANDBY mode during this test.
10.9.a CALIBRATE ERROR Setup
Connect a Manometer to the NIBP Sense (left) port. Inflate the mercury column to 15mmHg.
Press the NIBP START/STOP key.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
63
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
10.9.b CALIBRATE ERROR Verification
Verify that the pump does not start and CALIB message appears within 30 seconds. Release the
pressure from the Manometer and disconnect it from the NIBP port.
Test Part 11.0: INVASIVE PRESSURE Verification
(N/A if option is not installed)
11.1 Within the SETUPS/PARAMETER SELECTION menu turn P1 and P2 ON. Select RETURN
to exit and press the NORMAL SCREEN function key. Connect the output of the
Pressure Simulator to 3160 P1 port.
11.2 Set the Pressure Simulator to output 000mmHg. Using the selector knob on the CART
display, enter the P1 menu and select ZERO SET. ZEROING Pressure channel 1 box
appears displaying P1 DONE and OK. Wait for the ZEROING Pressure channel 1 box to
disappear.
11.3 Verify the P1 numeric shows 0 1 count.
11.4 Set the Pressure Simulator to output 200 mmHg. Verify the P1 numeric increase in a
positive direction and stabilize at 2002.
11.5 Set the Pressure Simulator to output 000mmHg. Using the selector knob on the CART
display, enter the P1 menu and select ZERO SET. Verify the P1 numeric and waveform
return to zero.
11.6 Set the simulator to output the pressures as outlined in table 6. Verify the Table 6
pressures are displayed within the listed tolerances.
11.7 Verify pressure selections of 250 and above causes OVR to be displayed.
11.8 Unplug the Pressure Simulator output cable from 3160 P1 and reconnect to P2.
11.9 Set the Pressure Simulator to output 000mmHg. Using the selector knob on the CART
display, enter the P2 menu and select ZERO SET. ZEROING Pressure channel 2 box
appears displaying P2 DONE and OK. Wait for the ZEROING Pressure channel 2 box to
disappear.
11.10 Verify the P2 numeric and waveform return to zero.
11.11 Set the simulator to output 200 mmHg. Verify the P2 numeric increase in a positive
direction and stabilize at 200 2.
11.12 Set the Pressure Simulator to output 000mmHg. Using the selector knob, enter the P2
menu and select ZERO SET.
11.13 Verify the P2 numeric and waveform return to zero.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
64
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
11.14 Set the simulator to output the pressures as outlined in table 6.
Note: The systolic, diastolic and mean values should read within ±1mmHg of one another.
11.15 Verify the Table 6 pressures are displayed within the listed tolerances.
11.16 Verify pressure selections of 250 and above causes OVR to be displayed.
11.17 Unplug the Pressure Simulator output cable from 3160 P2 port.
Table 6
Pressure Transducer Simulator Trace P1 (P2) Numeric Display
0 0 1
200 200 2
0 0 1
40 40 1
100 100 1
200 200 2
250 OVR
Note: The systolic, diastolic and mean values should read within ±1mmHg of one another.
Test Part 12.0: ANESTHETIC AGENTS Verification
(N/A if option is not installed)
Note: Even though AGENTS can also measure ETCO2, verify that the AGENTS option is installed by
going into the S/W REV screen. Under GAS, “AR” =AGENTS.
12.1 FLOW MEASUREMENT Verification
12.1.a With the AGENTS parameter already turned ON, the Water Trap and sample tubing
attached, and O2 cell installed (as stated in step 1.4.b of this section), verify the ETCO2
WARM‐UP message is no longer displayed and the exhaust port is open.
12.1.b Connect a Flowmeter to the end of the clear sample line. Verify that the flow is
200ml/min 20ml/min.
12.1.c Press the SETUP function key to enter the SETUPS menu and set PATIENT to NEO. Verify
that the flow is 150ml/min + 15ml/min. Return patient type to ADULT.
12.1.d Remove the water trap and place the Flowmeter on the left port (looking at the
monitor) in the water trap well while leaving the right port open. Verify that the flow is
within 35ml/min 15ml/min.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
65
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
12.1.e Place the Flowmeter on the right port (looking at the monitor) in the water trap well
while leaving the left port open. Verify that the flow is 165ml/min 15ml/min. Remove
the flowmeter and re‐connect the water trap to the water trap well. Reconnect sample
line to the water trap.
12.2 OCCLUSION Verification
12.2.a Plug the sample line input with a fingertip and verify “CO2 OCCLUSION” is displayed
within 30 seconds.
12.2.b Verify READJUSTING CO2 ZERO is displayed at the top of the CART display.
12.3 GAS MEASUREMENT Verification
12.3.a Connect 9010F (10%CO2/ 50%N2O) check gas to agent sample line. Apply 9010F check
gas.
12.3.b Verify the unit detects CO2 and measures 76mmHg 9mmHg, also verify the unit
detects N2O and measures 50% 5%. The check gas flow should be flowing for at least
2 minutes before a CO2 reading is recorded. Disconnect the check gas.
12.3.c Record CO2 and N2O readings in the acceptance column.
Test Part 13.0: LOW‐FLOW ETCO2 Verification
(N/A if option is not installed)
Note: To verify that the ETCO2 option is installed, enter into the S/W REV screen. Under GAS,
“PEC” =ETCO2.
Note: The message “ETCO2: LOW FLOW” will appear when sample line and or the water trap is
not attached.
13.1 FLOW MEASUREMENT Verification
13.1.a With the ETCO2 parameter already turned ON, the Water Trap and sample tubing
attached (as stated in step 1.1.a of this section), verify the ETCO2 WARM‐UP message is
no longer displayed and the exhaust port is open.
13.1.b Highlight the ETCO2 box and press the rotary knob to bring up the ETCO2 menu and
select ZERO CAL.
13.1.c Verify READJUSTING CO2 ZERO is displayed at the top center of the CART display screen.
Wait until message disappears.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
66
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
13.1.d Connect a flowmeter to the end of the blue sample line. Verify that the flow is
80ml/min 16ml/min.
13.1.e Remove the water trap and place the flowmeter on the left port (looking at the monitor)
in the water trap well while leaving the right port open. Verify that the flow is within
10ml/min 8ml/min.
13.1.f Place the flowmeter on the right port (looking at the monitor) in the water trap well
while leaving the left port open. Verify that the flow is 80ml/min 16ml/min. Remove
the flowmeter and re‐connect the water trap to the water trap well. Reconnect sample
line to the water trap.
13.1.g Place the flowmeter on the zero port (under the left edge of the Patient Connection
box). Bring up the ETCO2 menu again and select ZERO CAL. Verify that the flow is
within 80ml/min 16ml/min. Disconnect the flowmeter.
13.1.h Place the flowmeter on the end of the sample line and block off exhaust port (rear of
CART base). Verify that the flow drops to 0ml/min. Disconnect the flowmeter.
13.2 OCCLUSION Verification
13.2.a Plug the sample line input with a fingertip and verify “CO2 OCCLUSION” is displayed
within 30 seconds.
13.2.b Verify READJUSTING CO2 ZERO is displayed at the top of the CART display.
13.3 CO2 MEASUREMENT Verification
13.3.a Connect a nasal cannula to the CO2 sample line. Place the cannula on self and breathe
normally through nose.
13.3.b Verify the CART detects CO2 and measures 34 and 43 mmHg. Also verify the ETCO2
waveform is consistent with the operator’s normal respiration rate. Typical
measurement is 10‐16 BPM.
13.3.c Record CO2 reading in the acceptance column.
Test Part 14.0: RESPIRATION Verification
(N/A if option is not installed)
14.1. Within the SETUPS / PARAMETER SELECTION menu, turn on RESPIRATION.
14.2. Connect the respiration bellows tubing connection to the Respiration port on the
WSPO2 module and the bellows portion to the operator’s chest/stomach region.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
67
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
14.3. With breathing normally, verify the CART displays a RESP rate consistent with the
operator’s normal respiration rate. Typical measurement is 10‐16 BPM.
Test Part 15.0: TEMPERATURE Verification
(N/A if option is not installed)
15.1. Within the SETUPS / PARAMETER SELECTION menu, turn on TEMPERATURE.
15.2. Connect the FISO Temperature Probe (REF 9320) to the CART Temperature port.
15.3. Verify that the ambient temperature reading is displayed. Disconnect the probe.
Test Part 16.0: GATING Verification
(N/A if customer cannot provide the gating cable. This will indicate that the option was not purchased.)
16.1 FIELD SERVICE Verification
16.1.a Connect the gating cable to the WPU. Connect the other end of the gating cable to the
gating interface on the magnet.
16.1.b. Within the ECG menu, select ECG TEST SIGNAL, select ECG.
16.1.c Verify a 1mV pulse signal with a QRS count of 60BPM.
16.1.d Have the MR Tech select (Third Party) on the MR console and confirm a gating pulse is
observed at the MR console.
16.2 BENCH REPAIR Verification
Note: “TFxxxx” are part numbers for the Test Fixtures located at the Repair Center ONLY and are
not available for purchase.
16.2.1 ECG 5 VOLT DIGITAL PULSE Verification
16.2.1.a Connect the WECG leads to their corresponding lead‐binding posts of the medSim
300B (the patient simulator).
16.2.1.b Turn on the patient simulator, select ECG, select BASE, select BPM, and then
select 60. The number 60 should be flashing. The simulator is now outputting an
ECG signal of 60 BPM.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
68
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
16.2.1.c Connect TF0240 into PA558A of the WPU gating port. A digital scope probe
ground connected to TF0240 pin B (common), and probe to TF0240 pin A (signal).
16.2.1.d Adjust the digital scope vertical scale to 1Volt/Div and adjust the horizontal scale
to 500 ms/Div.
16.2.1.e On the 3160 DCU screen, select the ECG icon and make sure, set if necessary, the
GATING SOURCE is ECG.
16.2.1.f Observe that the digital scope displays a positive pulse train of approximately 5
Volts in amplitude as shown in the following figure:
ECG 5 VOLT DIGITAL PULSE
16.2.2 ECG NEGATIVE 5 VOLT DIGITAL PULSE Verification
16.2.2.a Retain the WECG lead connections and the patient simulator settings as described
above.
16.2.2.b TF0240 connected to PA558A. A digital scope probe ground connected to TF0240
pin B (common), and probe to TF0240 pin F (signal).
16.2.2.c Adjust the digital scope vertical scale to 1Volt/Div and adjust the horizontal scale
to 500 ms/Div. Adjust the vertical position of the baseline so that it is in the upper
portion of the screen.
16.2.2.d From ECG box display on DCU display or remote display, select ECG as the GATING
SOURCE.
16.2.2.e Observe that the digital scope displays a negative pulse train of approximately ‐5
Volts in amplitude as shown in the following figure:
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
69
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
ECG NEGATIVE 5 VOLT DIGITAL PULSE
16.2.3 ECG 1 VOLT ANALOG SIGNAL Verification
16.2.3.a Retain the above settings except for the horizontal scale setting for the scope. Set
this value to 250 ms per division.
16.2.3.b TF0240 connected to PA558A. A digital scope probe ground connected to TF0240
pin B (common), and probe to TF0240 pin D (signal).
16.2.3.c Observe that the digital scope displays an analog signal of approximately 1 Volt in
amplitude as shown in the following figure:
ECG 1 VOLT ANALOG SIGNAL
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
70
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
16.2.4 ECG 1mV ANALOG SIGNAL Verification
16.2.4.a Retain the above settings except for the vertical scale setting of the scope. Set this
value to the lowest possible scale (2 mV/Div).
16.2.4.b Install the AS131 adapter in between scope channel (e.g. channel 1) input and the
scope probe. This is necessary for the scope to display signals of low amplitude.
Make sure X1 probe is used for this test.
16.2.4.c TF0240 connected to PA558A. A digital scope probe ground connected to TF0240
pin B (common), and probe to TF0240 pin H (signal).
16.2.4.d Observe that the digital scope displays an analog signal of approximately 1 mV in
amplitude as shown in the following figure:
ECG 1mV ANALOG SIGNAL
16.2.5 IBP 200 mV ANALOG SIGNAL Verification
16.2.5.a Verify that P1 is turned on and displayed on the CART display.
16.2.5.b Connect an IBP cable from the medSim 300B (the simulator) BP1 output to P1
input of the 3160 Interface Unit (IU).
16.2.5.c On the simulator, select BP, channel 1, WAVE, then “atm”.
16.2.5.d On the CART, select P1 icon then ZERO SET. Make sure the operation is successful.
Select “art” on the simulator. The CART display should show an IBP
waveform within a short period of time.
16.2.5.e Set the scope vertical scale to a value between 100 – 500 mV.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
71
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
16.2.5.f TF0240 connected to PA558A. A digital scope probe ground connected to TF0240
pin B (common), and probe to TF0240 pin E (signal).
16.2.5.g Observe that the digital scope displays an analog signal of approximately 200 mV
in amplitude as shown in the following figure:
IBP 200 mV ANALOG SIGNAL
16.2.6 SPO2 20 mV ANALOG SIGNAL Verification
16.2.6.a If one is used, power on the Bapco, select PULSE OXIMETRY then set the simulated
SPO2 level to a value greater than 90% and heart rate to a value between 60 and
120 BPM.
16.2.6.b Connect the SPO2 sensor to the Bapco finger (or other SPO2 source). Turn power
ON the WSPO2 module. Observe that within a few seconds, the SPO2 waveform
is displayed on the DCU screen.
16.2.6.c Set the digital scope vertical scale to 20 mV/Div.
16.2.6.d Install the AS131 adapter in between the scope channel (e.g. channel 1) input and
the scope probe.
16.2.6.e TF0240 connected to PA558A. A digital scope probe ground connected to TF0240
pin B (common), and probe to TF0240 pin G (signal).
16.2.6.f Observe that the digital scope displays an analog signal of approximately 20 mV in
amplitude as shown in the following figure:
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
72
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
SPO2 20 mV ANALOG SIGNAL
16.2.7 SPO2 2 VOLT ANALOG SIGNAL Verification
16.2.7.a Retain the above SPO2 connections and settings.
16.2.7.b Remove the AS131 adapter. Connect the probe directly to channel 1 input of the
scope.
16.2.7.c Set the digital scope vertical scale to 1 V/Div.
16.2.7.d TF0240 connected to PA558A. A digital scope probe ground connected to TF0240
pin B (common), and probe to TF0240 pin J (signal).
16.2.7.e Observe that the digital scope displays an analog signal of approximately 2 V in
amplitude as shown in the following figure:
SPO2 2 VOLT ANALOG SIGNAL
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
73
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
16.2.8 RESPIRATION 1 VOLT ANALOG SIGNAL Verification
16.2.8.a Verify that the 3160 SPO2 and RESP parameters are ON.
16.2.8.b Connect the respiration sensor (the bellows) line to the resp input of the
WSPO2. Install a battery to power on the module. A signal baseline should
appear on the SPO2 slot of the DCU display.
16.2.8.c Squeeze/release or tap the bellows in an even pressure and at approximately
once every 2 seconds to produce a respiration reading of about 30 BPM as
shown by the numeric indicator in the RESP icon. A QRS audible count signal
may be used as a guide.
16.2.8.d TF0240 to PA558A. A digital scope probe ground connected to TF0240 pin B
(common), and probe to TF0240 pin C (signal).
16.2.8.e Adjust the digital scope vertical scale to 1Volt/Div and adjust the horizontal
scale to 500 ms/Div.
16.2.8.f Observe that the digital scope displays an analog signal of approximately 1 V in
amplitude (amplitude may vary depending on the force applied) as shown in
the following figure:
RESPIRATION 1 VOLT ANALOG SIGNAL
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
74
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
Test Part 17.0: RF TEST Verification
17.1 FIELD SERVICE Verification
RF Test with MR system available (Onsite)
Work with the MR Tech to position the CART inside MR room. Turn ON the 3160 System
and verify communication. Have the MR Tech run a MRI Test Scan and verify no noise
on image.
17.2 BENCH REPAIR Verification
17.2.a At the RF Test station, ensure that all equipment is turned on including 1)
Agilent 34970A Data Acquisition / Switch Unit, 2) HP 8560E Spectrum
Analyzer, 3) Agilent 8447D Amplifier (inside of shield room), 4) test computer,
5) display and 6) printer.
17.2.b On the computer display, double click the “Shortcut to RF Test.vi” icon. This
brings up the LabView Test main window.
17.2.c Place the UUT (unit under test) in the shield room so that the wheels are
properly aligned with the notches on the plywood floor system. This ensures
that the test is conducted uniformly across all units tested. Connect the unit
to AC power and turn it ON. Verify a successful power up. Close shield room
door and lock with handle.
17.2.d On the main window, click the “START TEST” icon. This brings up another
widow so that the following information can be added for documentation:
‐UUT model # (enter the 6NC number of the unit under test)
‐UUT serial #
‐operator’s initials
17.2.e When finished adding this information, select “DONE”. The test will start from
this point and run through a number of frequency spectrums checking for
acceptable noise levels.
17.2.f A test report will be printed automatically upon completion. This report will
say “PASS” or “FAIL” along with the information added in step 17.2.d. If a unit
fails, it will also include all portions of the test that did not pass.
17.2.g Attach report with system documentation.
Note: See Appendix F for complete accuracy check for the ECG, SPO2, NIBP, and Keypad.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
75
REF 989803173851 SECTION 6.0: TEST AND INSPECTION
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
76
APPENDIX A—CHANGING THE NETWORK NUMBER
Changing the CART or CRD Network Number
4. Highlight the desired number and press the rotary knob to select it, then scroll down and
select RETURN.
5. Verify that the Network Number selected above is shown at the bottom right corner of the
display screen:
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
77
REF 989803173851 APPENDIX A: CHANGING NETWORK NUMBERS
Changing the Wireless Modules Network Number
Step Action
1. If the module is currently ON, turn OFF the module by removing its battery.
2. Turn ON the module by inserting a 9065 battery. The network icons will flash briefly and then
the current network icon will illuminate (for example, Network 3 in the illustration below).
3. Enter the network change mode. After the current network icon has been illuminated (and
within 15 seconds from module power up) press and hold the network selection button until
the current network icon begins blinking rapidly then release the button.
Note: If the network change sequence was not started with 15 seconds after the module has been
turned ON, network changes will not be allowed. In this case, you must cycle module power
and restart the sequence.
5. Changing the network, press down again on the button until the icon stops blinking, then
release the button. When you do this, the next network icon in the sequence will blink
rapidly. (In other words, if the module was originally using network “2,” now the “3” icon will
be blinking.) Repeat this sequence of pressing down and releasing the button until the icon of
the network you prefer is rapidly blinking. If you pass the desired network, simply continue
pressing and releasing the button until the desired network is blinking again.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
78
REF 989803173851 APPENDIX A: CHANGING NETWORK NUMBERS
6. When you reach the desired network, press and hold the button for approximately 5 seconds to
lock and save the new network. The selected network's icon will turn OFF while the button is
depressed. Then it will illuminate (not blink) when the new network setting is saved. Once
illuminated, release the button. The module will begin using the selected network.
Note: Any part of the above sequence not completed will cause the module to revert to the
network previously set 30 seconds after the network selection button was last released.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
79
REF 989803173851 APPENDIX A: CHANGING NETWORK NUMBERS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
80
APPENDIX B—SOFTWARE PROGRAM UPDATE
CAUTION: Power can not be interrupted while the USB flash drive is reprogramming the CRD or
CART. Do not turn power off or remove the flash drive from the USB port during a
software update. If reprogramming is interrupted, refer to the CRD or CART PROGRAM
RECOVERY Section of this Appendix to determine if the program can be recovered or
the CRD or CART must be returned to the localized Repair Center for internal
programming.
Perform the following procedure to Update/Upgrade the 3160 Precess 865323 CART & 865485 CRD
software using the Invivo USB flash drive.
Part 1—Determining Software Revision
Step Action
1. Turn the CRD or CART on and let it boot normally.
2. Press the SETUP key and scroll down and select SERVICE(BIO‐MED), then Select S/W REV.
The DCU number and the WPU number shown will determine if the software is at current
revision.
S/W REV screen shown from a CRD communicating with a CART.
3. DCU, WPU, XIO, and DSP are the revisions updated from the flash drive.
4. Turn both the CART and CRD off.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
81
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
Part 2—Downloading the Software
Step Action
1. First obtain an Invivo certified USB flash drive (REF 453564158421) via SPS.
2. Insert the drive into a network connected PC equipped with a USB slot and a mouse, running
the Windows XP operating system.
3. Format the USB flash drive as follows:
Open windows explorer and ensure that the “Folders” view is visible.
Right‐Click on the drive letter of the inserted USB drive. Select “Format...” from the
menu that appears.
In the format dialog under “File System”, select “Fat”. Do not select “Fat 32” or any
other choice.
Click the “Start” button. If asked to confirm formatting, click “OK” or “YES” as
appropriate.
Click “OK” when the format is complete. Close the format dialog.
4. Access InCenter and download the current revision of software:
3160 Precess 865323 and CRD 865485 REF ET53633
Note: Only one revision of the software can be loaded onto the USB Flash Drive at a
time.
Each REF shown above will include the updates for both the WPU/CART and
DCU/CRD for each system.
5. Remove the USB drive from the computer.
6. Follow the below instructions to load the software. The USB flash drive can be used as many
times as needed until the next software update is released.
The CART & CRD are programmed independently and should not be
communicating with each other during the update.
If one unit at a facility is being upgraded to the current revision, it is mandatory
that all units at the facility be upgraded in case the CRDs are swapped around
among the CARTs.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
82
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
Part 3—Software Upgrade
3.1 CRD Program Update
Updating the programmable elements of the CRD is accomplished through the use of the USB flash
memory drive which contains the software and other data used by the CRD. During the reprogramming
process, the CRD will not function as a patient monitoring device. Patient monitoring capability will be
restored only once the reprogramming process has successfully completed and the CRD has been
powered off and then back on, and is once again communicating with a CART containing a compatible
program.
WARNING: The CART & CRD are programmed independently and should not be communicating
with each other during the update.
Step Action
1. Turn the CART OFF.
2. Remove the antenna from the rear of the CRD.
3. Remove the three (3) screws from the service panel on the rear of the CRD.
4. Connect the AC Power Adapter of the CRD to facility power.
5. Turn on the DCU and wait until it fully boots.
6. Insert the USB Device containing the desired program into the USB connector on the rear of
the CRD.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
83
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
7. The DCU will display the DCU Program Update Window.
8. With the Rotary Knob, highlight and select YES to proceed.
9. During reprogramming, the DCU Program Update Dialog will change to show the current
progress.
10. Once the DCU has been reprogrammed with all applicable program elements, the DCU
Program Update Dialog will reflect this.
11. Turn the DCU OFF and remove the USB flash drive. Re‐secure the service panel to the rear of
the unit.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
84
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
12. Perform the COLD START procedure below (step 3.2).
13. After COLD START, press the SETUP key. Select SERVICE (BIO‐MED), then select S/W REV
and verify the software revision that was just updated is shown.
3.2 CRD Cold Start
Perform the following COLD START procedure to the DCU unit after any Software Updates or if user
wishes to erase any stored USER settings:
Step Action
1. Set the Power Switch on the DCU to the OFF ( ) position.
2. Press and hold the Rotary Knob while turning the DCU Power Switch to ON ( ).
3. When the blinking cursor on the left side of the displays jumps up to the upper left corner of
the display (in approximately 10‐15 seconds), release the Rotary Knob, then immediately
press and hold the NORMAL SCREEN Control Key.
4. When the Cold Start banner is momentarily displayed, release the NORMAL SCREEN Control
Key. The unit will continue to boot to the normal screen.
5. If the COLD START banner is not displayed, repeat steps 1 thru 4.
3.3 CRD Program Recovery
If the reprogramming of a CRD is interrupted or halted due to the CRD losing power or the removal of
the USB program update device, it is possible that the unit may no longer function properly. To
determine if the CRD is still functional when this has happened, perform the procedure below:
Step Action
1. If the CRD is currently powered ON, turn it OFF.
2. If the USB program update device is still inserted into the CRD, remove it.
3. Turn the CRD ON. If the Normal Screen does not appear within one minute, the CRD is no
longer functional.
4. If the CRD is functional, repeat the normal CRD Program Update procedure to ensure that the
CRD is currently reprogrammed with all necessary program elements on the USB program
update device.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
85
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
5. If the CRD is NOT functional, perform the following procedure:
Turn the CRD OFF.
Insert the USB program update device into the USB connector on the rear of the CRD.
Turn the CRD ON. The Invivo splash screen will appear, and then the following text
will be displayed:
DCU OPERATIONAL PROGRAM UPDATE IN PROGRESS.
DO NOT REMOVE USB DRIVE FROM DCU!
0 . . . 1 . . . . 2 . . . . 3 . . . . 4
The unit will begin reprogramming the operational software from the USB device. A
series of “X” characters will appear below the number scale, indicating the progress
of reprogramming. Do not turn off the CRD, and do not remove the USB device from
the unit while reprogramming is in progress.
When reprogramming is complete, the following text will be displayed:
DCU OPERATIONAL PROGRAM UPDATE COMPLETE.
TURN DCU OFF, THEN REMOVE USB DRIVE.
When this text appears, turn OFF the CRD and remove the USB device from the rear
of the unit.
Turn the CRD back ON, verify that the Normal Screen is displayed, and proceed to the
last step in this section. If the Normal Screen does not appear after one minute,
contact Invivo Technical Support for further assistance.
To ensure that the CRD is reprogrammed with all necessary program elements on the
USB program update device, repeat the normal CRD Program Update procedure.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
86
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
3.4 CART Program Update
Updating the programmable elements of the CART is accomplished through the use of the USB flash
memory drive which contains the software and other data used by the CART. During the
reprogramming process, the CART will not function as a patient monitoring device. Patient monitoring
capability will be restored only once the reprogramming process has successfully completed and the
CART has been powered off and then back on.
WARNING: The CART & CRD are programmed independently and should not be communicating
with each other during the update.
Step Action
1. Connect the AC Power Adapter to the CART and insert at least one (1) fully charged battery
into the battery compartment.
2. Turn the CART ON and wait until the Normal Screen is displayed.
3. Open the service panel on the rear of the CART.
4. Insert the USB Program Update Device containing the desired program into the USB
connector on the rear of the CART.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
87
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
5. WPU Program Update Window.
6. With the Rotary Knob, highlight and select YES to proceed.
7. During reprogramming, the WPU Program Update Dialog will change to show the current
progress.
8. Once the CART has been reprogrammed with all applicable program elements, the WPU
Program Update Dialog will reflect this.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
88
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
9. Turn the CART OFF and remove the USB flash drive. Re‐secure the service panel to the rear
of the unit.
10. Perform the COLD START procedure below (step 3.5).
11. After COLD START, press the SETUP key. Select SERVICE (BIO‐MED), then select S/W REV
and verify the software revision that was just updated is shown.
Note: The WPU Program Update Dialog will display this update window if the WPU already has
the same revisions as on the Program Update Device.
3.5 CART Cold Start
Perform the following COLD START procedure to the CART unit after any Software Updates or if user
wishes to erase any stored USER settings:
Step Action
1. Set the Power Switch on the CART to the OFF ( ) position.
2. Press and hold the Rotary Knob while turning the CART Power Switch to ON ( ).
3. When the blinking cursor on the left side of the displays jumps up to the upper left corner of
the display (in approximately 10‐15 seconds), release the Rotary Knob, then immediately
press and hold the NORMAL SCREEN Control Key.
4. When the Cold Start banner is momentarily displayed, release the NORMAL SCREEN Control
Key. The unit will continue to boot to the normal screen.
5. If the COLD START banner is not displayed, repeat steps 1 thru 4.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
89
REF 989803173851 APPENDIX B: SOFTWARE PROGRAM UPDATE
3.6 CART Program Recovery
If the reprogramming of a CART is interrupted or halted due to the CART losing power or the removal of
the USB program update device, it is possible that the unit may no longer function properly. To
determine if the CART is still functional when this has happened, perform the procedure below:
Step Action
1. If the CART is currently powered ON, turn it OFF.
2. If the USB program update device is still inserted into the CART, remove it.
3. Turn the CART ON. If the Normal Screen does not appear within one minute, the CART is no
longer functional.
4. If the CART is functional, repeat the normal CART Program Update procedure to ensure that
the CART is currently reprogrammed with all necessary program elements on the USB
program update device.
5. If the CART is NOT functional, perform the following procedure:
Turn the CART OFF.
Insert the USB program update device into the USB connector on the rear of the
CART.
Turn the CART ON. The Invivo splash screen will appear, and then the following text
will be displayed:
WPU OPERATIONAL PROGRAM UPDATE IN PROGRESS.
DO NOT REMOVE USB DRIVE FROM WPU!
0 . . . . 1 . . . . 2 . . . . 3 . . . . 4
The unit will begin reprogramming the operational software from the USB device. A
series of “X” characters will appear below the number scale, indicating the progress
of reprogramming. Do not turn off the CART, and do not remove the USB device
from the unit while reprogramming is in progress.
When reprogramming is complete, the following text will be displayed:
WPU OPERATIONAL PROGRAM UPDATE COMPLETE.
TURN WPU OFF, THEN REMOVE USB DRIVE.
When this text appears, turn OFF the CART and remove the USB device from the rear
of the unit.
Turn the CART back ON, verify that the Normal Screen is displayed, and proceed to
the last step in this section. If the Normal Screen does not appear after one minute,
contact Invivo Technical Support for further assistance.
To ensure that the CART is reprogrammed with all necessary program elements on
the USB program update device, repeat the normal CART Program Update
procedure.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
90
APPENDIX C—REPLACEABLE EXTERNAL COMPONENTS
CART DC Fuse (REF FU39)
Remove the in‐line DC fuse as follows:
Step Action
1. Remove AC Power and remove batteries.
2. Loosen the captive screws that secure the hinged access panel on the rear of the CART.
3. Pull the 5A, 32V fuse out of the fuse housing on the rear panel of the CART base.
4. Reverse the above step to install a replacement fuse. Re-secure rear panel.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
91
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
CART Water Trap
Note: ONLY Anesthetic Agents‐equipped systems utilize the CEAR water trap (REF 94012) and
CLEAR tubing (REF 94018) for all procedures.
(REF 94012) (REF 94018)
ONLY Low‐Flow ETCO2‐equipped systems utilizes the BLUE water trap (REF 94020) and BLUE
tubing (REF 94021) for all procedures
(REF 94020) (REF 94021)
Always use Invivo‐supplied cannulas. (See “Accessories” in the IFU manual for details.)
Step Action
1. Water Trap Installation
2. Water Trap Removal.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
92
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
CART Disposable O2 Cell (REF 989803162051)
Note: The O2 Cell has a 15 month shelf life if kept sealed inside of the “can”. Life of the O2 Cell
installed in the CART will vary depending on usage of the Agents parameter. See IFU for
further information.
Expiration Date Label Locations
Outer packaging.
Labeled on the can.
On the O2 Cell itself.
There is no need to turn the CART off, just the Agent parameter. Turn OFF the Agents vital sign
parameter from SETUPS / PARAMETER SELECTION menu. Access to the oxygen (O2) sensor is provided
on the rear panel of the CART.
Note: In order to ensure the stability of the oxygen sensor, the manufacturer recommends waiting
at least 1 hour, after the package has been opened, before using the sensor.
To avoid this wait time, we recommend removing the oxygen sensor from the packaging as
soon as it received or prior to beginning monitoring. Always make note of the manufacture
date (as printed on the can), the sensor expires 15 months from the date of manufacture.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
93
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
Step Action
1. Remove the 2 screws securing the O2 cover plate on the rear of the CART.
2. Remove the oxygen sensor located at the rear of the CART by using the O2 sensor installation
tool (Part Number 989803162961) attached to the oxygen sensor port e the hinged access
panel on the rear of the CART.
3. Place the tool into the sensor slot and turn counterclockwise until the sensor is disengaged.
Pull out to remove.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
94
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
4. Thread the replacement O2 sensor into the sensor port, then using the O2 sensor tool, rotate
the sensor clockwise until it fits securely in port. Re‐secure O2 Cell cover plate.
5. Assure that ONLY the clear sampling line is connected to the water trap. The gas sampling
line must not be connected to the patient or any other gas source during oxygen sensor
replacement.
6. Turn ON the Agents parameter and allow the system to run until the message “ETCO2
WARMING UP” is no longer displayed at the top center of the Display screen.
7. Initiate an O2 pressure calibration by performing the following steps:
Press SETUP on the Display keypad
Rotate the knob to highlight the SERVICE(BIO‐MED) menu item, then press the knob
to select GAS CAL.
Select the O2 CAL menu item. A dialog will be displayed that reads: FLOW ROOM AIR
FOR 10 SECONDS, Do you wish to continue?
Once the user confirms the O2 calibration, a dialog box shall be displayed indicating
that the Agents parameter must be on for a minimum of 10 minutes (only if the
parameter has not been turned on yet).
This dialog box appears reminding that there should not be any connection to the
sample line and that the unit needs to sample room air for 10 seconds.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
95
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
Rotate the knob to highlight YES (it should already be highlighted by default) and
press the knob to select this choice. The message READJUSTING CO2 ZERO will be
shown near the top of the display. When this message disappears, O2 pressure
calibration is complete.
CART / CRD Antenna (REF 453564060151)
Remove the CRD Antenna as follows:
Step Action
1. Unscrew the Antenna from the threaded connection mounted on the chassis frame.
2. Reverse the above step to install a replacement antenna.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
96
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
Remove the CART Antenna as follows:
Step Action
1. Disconnect the AC line Cord from the AC Power Adapter mounted underneath the CART and
remove the 9989803169491 batteries from the CART.
2. Disconnect the DC Cord. Loosen the two (2) captive screws securing the O2 cell plastic cover.
Remove cover plate.
3. Lay unit on its back and remove the outer 4 small screws on the underside of CART base, next
to the wheels. Bring the CART back upright.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
97
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
4. Lift cover off of the base and put aside.
5. Unscrew the Antenna from the Electronics Box.
6. Slide the Antenna mast out from the plastic antenna holder.
7. Reverse steps 6 back to step 1 to reassemble.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
98
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
CART AC Power Adapter (REF 989803168201)
Step Action
1. Disconnect the AC line Cord from the AC Power Adapter mounted underneath the
CART and remove the 989803169491 batteries from the CART.
2. Disconnect the DC Cord. Loosen the two (2) captive screws securing the O2 cell
plastic cover. Remove cover plate.
3. Lay unit on its back and remove the outer 4 small screws on the underside of CART
base, next to the wheels. Bring the CART back upright.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
99
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
4. Lift cover off of the base and put aside.
5. Lay the CART back on its back again and remove the 4 larger inner screws. Hold the
Electronics box in place as the CART is brought upright again.
6. Slightly slide the Electronics box forward. Be careful not to pinch or strain any of the
wires, cables, or tubing.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
100
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
7. Using a long shafted Phillips screwdriver. Come in from the top of the O2 cell bracket
and remove the 2 flat headed screws holding the bracket to the chassis. Remove
bracket.
8. Remove the MR POWER CONVERTER from the packaging and remove the 4 round
labels covering the threaded holes of the new converter.
Note: Have the new converter ready as soon as you remove the old converter.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
101
REF 989803173851 APPENDIX C: REPLACEABLE EXTERNAL COMPONENTS
IF POSSIBLE, HAVE A 2ND PERSON AVAILABLE TO HELP IN THE NEXT 2 STEPS.
9. Support the pole in place and carefully loosen the four flat head screws holding the pole to
the chassis. These screws hold the MR Power Converter to the chassis bottom. Keep the
pole in place and loosen one screw at a time. Hold the MR Power Converter while removing
the last 2 screws.
10. Remove the Power Converter. Lift one screw at a time and apply blue loctite to the threads
of the screw and insert each screw back into the holes.
11. Lift the new MR POWER CONVERTER up and align the threaded insert with one of the flat
head screws. Do not tighten all of the way. Align the opposite flat head screw and slightly
tighten. Align the pole so that it is straight and finish threading the 2 remaining screws.
Tighten all 4 screws.
12. Reverse steps 7 back to step 1 to reassemble the CART.
NOTE: Step 6: After sliding the Electronics box back into place, verify that all cables, wires,
and tubing are free of any kinks and not pinched and all are attached properly.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
102
APPENDIX D—BATTERY TESTS
CART Battery (REF 989803169491) +14.4 VDC Test
When the CART batteries are removed from the system, the user can determine battery capacity by
pressing the battery’s Power Level button then observing the LEDs. The LEDs indicate the battery
capacity, in 20 percent increments, from 20 – 100 percent. Indications of battery capacity are also
available via the CART display and the CRD display. The minimum battery voltage value for normal
operation is 14.8V.
Perform the 989803169491 monitor battery test for the CART Assembly as indicated below:
Step Action
1. Turn the CART OFF and remove batteries.
2. Press the “POWER LEVEL” button located on each battery and perform the indicated action:
If all power level LED indicators are extinguished or the right‐most LED flashes
(voltage reading bad), replace the battery. (Dispose of used battery pack(s) as
specified in the Section 4 of this manual.)
If less than three (3) of the adjacent power level LED indicators on the battery are
illuminated solid (voltage reading low), reinstall the battery into the CART battery
compartment, connect the AC power to the CART and allow the battery to recharge
for a minimum of 8 hours.
If three (3) or more of the adjacent power level LED indicators on the battery are
illuminated solid (voltage reading good), reinstall the batteries into the CART battery
compartments.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
103
REF 989803173851 APPENDIX D: BATTERY TESTS
Wireless Module Battery (REF 989803152881) +4.1 VDC Test
Perform the battery test for the WECG / WSPO2 modules as indicated below:
Step Action
Remove the batteries from the WECG and/or WSPO2 transmitter module battery
1.
compartments (the batteries are interchangeable).
2. Connect a DMM across the exposed battery terminals.
If the battery is dead (fully depleted), replace the battery. (Dispose of used battery pack(s) as
3.
specified in the Section 4 of this manual.)
If the voltage measured is ≤ +3.3 Vdc (voltage reading low), recharge the battery in the
4.
Patient Module battery charger (Invivo Part Number 9023) for a minimum of 8 hours.
If the voltage measured is > +3.3 Vdc (voltage reading good), reinstall the batteries in the
5.
transmitter modules.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
104
APPENDIX E—GATING
The gating feature in the 3160 Precess outputs data and discrete signals to the MRI scanner system
resulting from the collection and processing of data from a monitored parameter. The scanner uses
these signals and data to precisely control the times that it collects MR image data from the patient.
There are two types of data output by the gating facility in the 3160 Precess:
Analog waveform are analog electronic representations of waveforms collected from
monitored parameters;
Gating pulses are discrete electronic signals that indicate that some physiological event
associated with a monitored parameter has occurred.
A connector to supply gating outputs and other signals shall be located at the rear of the CART. Cable
assemblies are available to interface this gating output connector to each manufacturer’s MRI system
(GE Horizon LX, Siemens Harmony, Siemens Symphony, Siemens Alvanto, Philips Intera, etc.).
Gating outputs at the CART will be available through an RF shielded I/O connector.
GATING CONNECTOR PIN SPECIFICATIONS
Pin Wire
Name Descriptions and Characteristics
Designator Color
ECG/SPO2 digital gating pulse.
A Orange Digital Gating Pulse Peak to peak voltage: 3.3V to 5.0V
Pulse duration: 10 3ms
B Black Signal Ground Return voltage reference for all other signal pins.
Analog respiration gating waveform signal.
Maximum output voltage: 5V
C Violet RESP 1 V Analog
Maximum current: 5mA
Peak‐to‐peak signal voltage: 1V
Analog ECG 1‐Volt waveform signal.
Output signal scaling: 1V/mV
D Red ECG 1 V Analog
Maximum output voltage: 5 V
Maximum current: 5mA
Analog IBP gating waveform signal.
E Green IBP 200mV Analog
Maximum output voltage: 200mV
ECG/SPO2 negative digital gating pulse.
Peak to peak voltage: 3.3V to 5.0V
F White Negative Gating Pulse
All other signal characteristics are identical
to Pin A (Digital Gating Pulse)
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
105
REF 989803173851 APPENDIX E: GATING
SPO2 IR/Red analog gating waveform signal.
G Blue SPO2 40mV Analog Signal scaling: 1 V/mV
Maximum output voltage: 40mV
H Yellow ECG 1mV Analog ECG analog gating waveform signal.
Signal scaling: 1mV/mV
Maximum output voltage: 20mV
Maximum current: 5mA
J White SPO2 2 V Analog SPO2 IR/Red analog gating waveform signal.
Signal scaling: 2
K,L,M,N,O N/A Unused Unused pins.
Analog Gating
To receive the analog ECG gating waveform through the gating connector, ensure that all of the
following conditions have been met:
1. That the system is communicating with the WECG module,
2. That the WECG module is properly attached to the patient, and
3. That a Lead Fail condition does not exist for the measured ECG signal.
Digital Gating
To receive the digital ECG gating pulse through the gating connector, ensure that all of the following
conditions have been met:
1. That the system is communicating with the WECG module,
2. That the WECG module is properly attached to the patient,
3. That a Lead Fail condition does not exist for the measured ECG signal,
4. That the ECG parameter has been activated in the menu system, and
5. That the ECG signal has been selected as the digital pulse source, as follows:
a. Turn the control knob until the ECG Vital Sign Numerics box is highlighted, and then press
the knob.
b. Turn the control knob to GATING SOURCE and then press the knob.
c. Turn the control knob to ECG and then press the knob.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
106
APPENDIX F—TROUBLESHOOTING
Refer to the IFU (Instructions for Use manual) for additional information
ANESTHETIC AGENTS
Refer to Test Part 1.0 Initial Setup in SECTION 6 for proper Water Trap and Sampling Line Preparation.
WARNING: Use only Invivo sampling lines and accessories, as other sampling lines will cause
inaccurate readings and malfunctions.
Replace the sampling line, replace the airway adapter, and inspect the water trap
between each patient use.
CAUTION: DO NOT over‐tighten the sampling line connection to the water trap. A half‐turn is all
that should be needed. Over‐tightening this connection may damage the water trap
and cause failure of the trap assembly.
Regularly Inspect gas exhaust/waste line for deterioration. Replace the line as needed.
WARM‐UP PERIOD
The Anesthetic Gas Sensor (AGS) requires a warm‐up period to thermally stabilize to achieve accurate
gas identification and measurement. The warm‐up period begins when the AGENTS or CO2 vital sign is
activated. Once this happens, the AGS will become fully operational according to the following
sequence:
1. During the warm‐up period, the message “CO2 WARMING UP” will be displayed, flashing in red
and white text.
2. Within 45 seconds of activation, the AGS will be able to identify gases and give gas
concentrations with ISO‐level accuracy. Wait during this period, as the vital sign numeric values
in the AGENTS, GAS, and CO2 Vital Sign numerics boxes will be displayed in the “No Data
Available” state (‐ ‐ ‐).
3. Within 10 minutes of activation, the AGS will be able to operate at full accuracy.
Determining if there is a Leak in the System
1. Perform test step 12.2 OCCLUSION Verification in SECTION 6. If the system will not occlude,
perform the following steps:
2. Remove the sample line first and block off patient port at the Water Trap. If the system
occludes, replace sample line.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
107
REF 989803173851 APPENDIX F: TROUBLESHOOTING
3. If a leak is still present, remove the Water Trap and block both Water Trap ports off. If the
system occludes, replace the Water Trap.
4. If a leak is still present, remove the cover off of the lower portion of the CART. Trace tubing to
the electronic box and remove tubing and block port. If the system occludes, open up the CART
Patient Connection box and verify good tubing connection between the Water Trap ports to the
Electronics box.
5. If a leak is still present, contact Technical Support.
Note: These text strings are abbreviations for the specific identified agents gas(es) detected:
• DES – Desflurane
• ENF – Enflurane
• HAL – Halothane
• ISO – Isoflurane
• SEV – Sevoflurane
Oxygen Sensor Depletion
The oxygen sensor uses galvanic technology and has a life of 15 months from the date of manufacture.
Therefore, you should note the manufacture date (printed on the oxygen sensor can) before installing
the sensor and plan accordingly for the time when the sensor should be replaced. If the O2 sensor
reaches the point where replacement is necessary, the message “TURN OFF CO2, REPLACE O2 SENSOR”
will be displayed. Replace the sensor as described in Appendix C.
AGENTS ACCURACY VERIFICATION:
(Performed on TF0160 Calibration Station at the Repair Center)
1. Apply M199 (5%CO2 with 60%N2O mix) from gas test fixture. Verify CO2 ±3mmHg and N2O
±3.0%. Turn M199 off.
2. Apply M237 (5%CO2) from gas test fixture. Verify CO2 ±2.0mmHg. Turn M237off.
3. Set GAS fixture with M243 (0.3% ISO with 5.0% CO2 / 60.0% N2O MIX). Verify ISO reading is
within ±0.25%. Turn M243 off.
Repeat for M229 (2.5% ±0.30%), and M230 (5.0% ±0.30%) ISO. Select purge function on the
test fixture until the monitor reads ZERO.
4. Set GAS Test Fixture with M244 (0.3% HAL with 5.0% CO2 / 50.0% N2O MIX). Verify reading is
within ±0.25%. Turn M244 off.
Repeat for M231 (2.5% ±0.30%), and M232 (5.0% ±0.30%) HAL
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
108
REF 989803173851 APPENDIX F: TROUBLESHOOTING
Select purge function on the test fixture until the monitor reads ZERO.
5. Set GAS Test Fixture with M245 (0.3% ENF with 10.0% CO2 / 50.0% N2O MIX). Verify reading is
within ±0.25%. Turn M245 off.
Repeat for M233 (2.5% ±0.30%), and M234 (5.0% ±0.30%) ENF. Select purge function on the
test fixture until the monitor reads ZERO.
6. Set GAS Test Fixture M246 (0.3% SEVO with 5 CO2 / 60.0% N2O MIX). Verify reading is within
±0.25%. Turn M246 off.
Repeat for M235 (2.5% ±0. 20%), and M236 (5.0% ±0.20%) SEVO. Select purge function on the
test fixture until the monitor reads ZERO.
7. Set GAS Test Fixture M242 (0.5% DES with 10.0% CO2 / 60.0% N2O MIX). Verify reading is
within ±0.25%. Turn M242 off.
Repeat for M226 (7.0% ±0. 50%), and M228 (17.0% ±1.10%) DES. Select purge function on the
test fixture until the monitor reads ZERO. Disconnect TF0160 output line from 3160P intake
port.
Parameter Messages:
Agents
Message Probable Cause Recommended Action
AGENT HW FAIL – A hardware failure associated with the O2 Ensure that the Agent O2 Sensor has not
O2 SENSOR sensor has occurred. become loose or dislodged; if so, tighten it with
the O2 Sensor tool.
If the condition remains, contact Tech Support
or Invivo (Philips)‐authorized service personnel
TURN OFF CO2, The O2 sensor has expired. Replace the O2 sensor. See Appendix C for
REPLACE O2 SENSOR replacement and calibration.
AGENT MOTOR SPEED 1) The system is too close to the magnet and Move the system away from the magnetic field.
ERROR agents operation is impacted. If the condition remains, contact Tech Support
2) A problem is detected in the agents or Invivo (Philips)‐authorized service personnel.
hardware.
CO2 OCCLUSION 1) The message “CO2 OCCLUSION” will be 1) Check the Patient Sampling Line for any
displayed when a sample line occlusion is bends, kinks or debris. If any are observed,
detected and flow is <40 ml/min. replace the Patient Sampling Line.
2) The water trap may be full of fluid. 2) Replace the water trap. If the condition
remains contact Tech Support or Invivo (Philips)‐
authorized service personnel.
CO2: HW FAIL The system CO2/Agents hardware has failed. Discontinue use of the CO2/Agents monitoring
and contact Tech Support or Invivo (Philips)‐
authorized service personnel.
CO2: LOW FLOW 1) Sampling line flow is reduced 10 percent from Checks the patient sampling line for any bends,
nominal. kinks or debris; and, if observed, replace the
2) This message may appear when a sampling line.
line is first connected. If the condition remains contact Tech Support or
Invivo (Philips)‐authorized service personnel.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
109
REF 989803173851 APPENDIX F: TROUBLESHOOTING
CO2 WARMING UP The message “ETCO2 WARMING UP” is No Action Needed
displayed until the agent bench is ready for use.
During that time agent readings will not be
displayed.
MAGNETIC FIELD TOO The system is too close to the magnet and Move the system away from the magnetic field.
HIGH agents operation is impacted. If the condition remains, contact Tech Support
or Invivo (Philips)‐authorized service personnel.
MULTIPLE AGENTS In the event of a mixed agent condition, the No Action Needed
message “MULTIPLE AGENTS” will be displayed.
No audible alarm
OCCLUSION WHILE A sample line occlusion was detected by the 1) Check the patient sampling line for any bends,
ZEROING: system at start up. kinks or debris; and, if observed, replace the
ATTEMPTING TO line.
RESTART 2) Replace the water trap.
If the condition remains, contact Tech Support
or Invivo (Philips)‐authorized service personnel.
READJUSTING CO2 Agent hardware is performing an automatic Zero No Action Needed
ZERO adjustment
WARNING: Unable to The agents function is unable to start properly Move the Cart away from the magnetic field.
monitor patient airway due to the presence of a high magnetic field. If the condition remains, contact Tech Support
gases, temporarily or Invivo (Philips)‐authorized service personnel.
move WPU away from
magnet
ECG
Patient Preparation:
1. Verify Wireless ECG Module is set to the correct network and is communicating with the CART.
2. Check the expiration date of the Quadtrode electrode.
3. Shave any hair from the application site.
4. Abrade the skin:
Apply a sufficient amount of Prep Gel (9009) to a gauze pad or cloth;
Rub the site (skin may turn pink);
Wipe off any excess gel.
WARNING: DO NOT USE ALCOHOL TO PREP THE SKIN. THIS TENDS TO DRY OUT THE SKIN AND
THE PREP GEL IS USED TO GET RID OF ANY DEAD OR DRY SKIN.
5. Apply the Quadtrode electrode
6. Attach ECG cable between the ECG module and patient
Keep the wireless module outside the field of view.
Avoid “U” or “S” shaped loops, this can increase the risk of heating.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
110
REF 989803173851 APPENDIX F: TROUBLESHOOTING
How to Measure Signal Strength
Evaluate each patient before they enter the scanner. It is the best time to correct any problem.
Minimum Signal Qualification
Note: Scale settings only change how the QRS complex is displayed, reducing of amplifying the
signal but also any noise.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
111
REF 989803173851 APPENDIX F: TROUBLESHOOTING
Common causes of noise:
Customer using alcohol‐based products during prep procedure
Expired or dried Quadtrodes
Wrong or damaged leads
Improper placement of Quadtrode
Unit is inside the 5000 gauss line
System is set to “monitor mode” during a diffusion sequence
Note: Another ECG NOISE troubleshooting tip is to use the “Advanced Filter” CV ECG Cable, REF
989803170121. This cable is approximately 3 feet long and can bring the ECG Module
outside of the bore. It is used with CV Quadtrodes ONLY.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
112
REF 989803173851 APPENDIX F: TROUBLESHOOTING
FILTER MODE
Allows you to set the ECG filter used during the MRI sequences
Monitor Provides filtering characteristics that meet
the specification of the Association for the
Advancement of Medical Instrumentation
(AAMI). Note that this filter will not provide
optimum performance during active MRI
sequences.
MRI 0.15–1.5T (A) Provides optimum performance, utilizing an
adaptive filter scheme for removal of
gradient artifacts, on 0.15 to 1.5 Tesla MR
systems during non‐ Cardiovascular (CV)
MRI sequences (default).
MRI 0.15–1.5T (B) Provides optimum performance, utilizing an
adaptive filter scheme for removal of
gradient artifacts, on 0.15 to 1.5 Tesla MR
systems during Echo Train MRI sequences.
Cardiac 1.5–3.0T Provides the optimum ECG performance,
utilizing an adaptive filter scheme for
removal of gradient artifacts, during
Cardiovascular (CV) MRI procedures that
involve steady state free precession imaging
with balanced gradient (True‐FISP, FIESTA,
or Balanced FFE) sequences on 1.5 and 3.0
Tesla MR systems.
3.0T Provides optimum performance, utilizing an
adaptive filter scheme for removal of
gradient artifacts, on 3.0 Tesla MR systems
during non‐Cardiovascular (CV) MRI
sequences.
Note: Due to the variety of MRI sequence characteristics, the filter mode recommendations
above may not provide optimum performance in all cases; therefore, in situations where
the recommended mode does not provide the best results, the selection of other filter
modes may improve ECG performance.
ECG performance can be affected by the ECG electrode placement, the MRI procedure, the
image slice angle, and the image slice thickness. In situations where ECG performance is
not optimal, select the ECG lead (I, II, III, AVL, AVR or AVF) that provides the best ECG
performance.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
113
REF 989803173851 APPENDIX F: TROUBLESHOOTING
Note: Some pediatrics have a narrow QRS wave which may not be
detected by the heart rate counter with Adult patient type selected.
Pediatric ECG is automatically enabled when the patient type is set
to Neonatal or Pediatric. And is optional when Adult is selected.
It may be necessary to cycle filters and/or lead views through an
exam to account for system variability and/or scan sequence.
For cases requiring cardiac gating, start with the Cardiac
filter in Lead II and switch filters if gradient noise is noticed.
If gradient artifact is still present, check the signal
amplitude and try Lead I or Lead III.
For cases not requiring gating, start with the MRI 0.15‐
1.5T(B) filter and switch filters if gradient noise is noticed.
If gradient artifact is still present, check the signal strength
and try Lead I or Lead III.
Parameter Messages:
ECG
Message Probable Cause Recommended Action
LEAD FAIL A faulty or disconnected ECG lead or electrode / Ensure that all leads are connected to the
Quadtrode application is detected by the system. patient electrodes or Quadtrodes and that the
ECG lead set is connected to the WECG module.
Ensure proper application of ECG electrodes or
Note: An inoperative ECG parameter or
Quadtrodes. (Refer to ECG Patient Site
WECG module is indicated by
Preparation and Electrode Connections, in the
absence of an ECG waveform
IFU.).
and simultaneous Lead Fail
alarm.
If the problem persists, replace ECG leads
and/or electrodes / Quadtrodes with another
set of Invivo‐recommended ECG accessories:
see Accessories in the IFU.
WARNING Failure to respond to a Lead Fail alarm will cause a lapse in the monitoring
of the patient.
LEAD SATURATION The DC voltage offset of the ECG input signal is Adjust the electrode or Quadtrode placement.
too large for the system to process and display (Refer to Electrode Site Selection in IFU.)
the waveform.
Note: Until corrected, the ECG numeric
A saturation condition shall be reported by the values are removed from the
system within 10 seconds of the loss of the ECG Vital Sign Numeric box and an
waveform. alarm tone is generated.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
114
REF 989803173851 APPENDIX F: TROUBLESHOOTING
OVERSCALE The scale of the ECG waveform is too large. The Reduce the scale by accessing the SCALE menu
tops of the ECG waveforms are “clipped” (that is, option in the ECG menu.
the waveform peaks are cut off).
Note: This condition will not generate an
alarm tone.
ECG ACCURACY VERIFICATION:
1.0 ECG Trace A
1.a LEAD II setup (at 0.5mV output at 60 BPM)
With 9065 battery inserted into the WECG module and communicating to the 3160 system,
connect the ECG cable to the WECG module. Connect the ECG leads to the Patient Simulator as
indicated in Table 4 below (as a reference Table 5 illustrates the ECG Leads to Lead Wires/Colors
Scheme):
Table 4
LEAD COLOR CODE from ECG CABLE PATIENT SIMULATOR TERMINALS
GREEN RL
WHITE RA
BLACK LA
RED LL
Patient Simulator ECG Lead Attachments
Set the Patient Simulator to output a 0.5mV QRS pulse at 60BPM (NORMAL SINUS mode)
Within the ECG menu:
Set TRACE A LEAD to II
Set TRACE B LEAD to OFF
Set SCALE of 10 mm/mV
FILTER MODE set to MON
Set HR TONE SOURCE and select QRS
With the SETUPS Menu, verify PATIENT is set to ADULT.
1.b LEAD II Verification
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 60 BPM 1BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
115
REF 989803173851 APPENDIX F: TROUBLESHOOTING
1.c LEAD III Setup
Within the ECG menu, change TRACE A LEAD to III.
Keep the remaining settings as in step 7.1.a.
1.d LEAD III Verification
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 60 BPM 1BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
1.e LEAD I Setup
Within the ECG menu, change TRACE A LEAD to I.
Keep the remaining settings as in step 7.1.a.
1.f LEAD I Verification
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 60 BPM 1BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
1.g LEAD II Setup (at 2mV output at 60 BPM)
Set the Patient Simulator to output a 2mV QRS pulse at 60BPM (NORMAL SINUS mode).
Within the ECG menu, set TRACE A LEAD to II.
Keep the remaining settings as in step 7.1.a.
1.h LEAD II Verification
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 60 BPM 1 BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
1.i LEAD II Setup (at 2mV output at 120 BPM)
Set the Patient Simulator to output a 2mV QRS pulse at 120 BPM (NORMAL SINUS mode).
Keep the remaining settings as in step 7.1.a.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
116
REF 989803173851 APPENDIX F: TROUBLESHOOTING
1.j LEAD II Verification
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 120 BPM 1 BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
1.k LEAD II Setup (at 2mV output at 240 BPM)
Set the Patient Simulator to output a 2mV QRS pulse at 240 BPM (NORMAL SINUS mode).
Keep the remaining settings as in step 7.1.a.
1.l LEAD II Verification
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 240 BPM 5 BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
1.m LEAD II Setup (at 2mV output at 300 BPM)
Set the Patient Simulator to output a 2mV QRS pulse at 300 BPM (NORMAL SINUS mode).
Keep the remaining settings as in step 7.1.a.
1.n LEAD II Verification
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 250 BPM and OVR.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
1.o ECG SIGNAL TEST Setup
Within the ECG menu, select ECG SIGNAL TEST.
1.p ECG SIGNAL TEST Verification
TRACE A shows a calibration waveform at a rate of 1mV at 1 Hz and 10% duty cycle.
ECG numerics show a count of 60 BPM 1 BPM.
Within the ECG menu, turn the ECG SIGNAL TEST off.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
117
REF 989803173851 APPENDIX F: TROUBLESHOOTING
1.q TRACE A LEAD FAIL Setup
Set the Patient Simulator to output a 1.5mV QRS pulse at 60BPM (NORMAL SINUS mode)
Within the ECG menu:
Set TRACE A LEAD to I
Set TRACE B LEAD to OFF
Set SCALE of 10 mm/mV
FILTER MODE set to MON
Set HR TONE SOURCE and select QRS
With the SETUPS Menu, verify PATIENT is set to ADULT.
1.r TRACE A LEAD FAIL Verification
Remove one wire at a time (that pertains to the selected lead—see Table 5). (Example: For
LEAD I, remove RA (White Wire), then after LEAD FAIL message is displayed, reattach the wire.
After the waveform returns, remove LA (Black Wire). Rate Tone is present with NO double
tones.
Table 5
ECG Trace A/B Leads(s) Patient Simulator Terminals
I RA, LA
II RA, LL
III LA, LL
AVL, AVR, AVF RA, LA, LL
Patient Simulator Terminal Selections
In each case verify that within 25 seconds of removal of each wire that the "LEAD FAIL" message
appears to the right of the selected lead at the top left of the display screen and that there is no
QRS Tone or Number displayed. Verify that the trace recovery time is within 25 seconds of Lead
Fail Correction.
1.s ECG NEONATE SENSITIVITY Setup
Set the Patient Simulator to output a 0.15mV QRS pulse at 80BPM (NORMAL SINUS mode)
Within the ECG menu:
Set TRACE A LEAD to III
Set TRACE B LEAD to OFF
With the SETUPS Menu, verify PATIENT is set to ADULT.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
118
REF 989803173851 APPENDIX F: TROUBLESHOOTING
1.t ECG NEONATE SENSITIVITY Verification
Verify while still in ADULT mode, there is no QRS Tone and numeric count of 0 BPM is displayed
in the ECG icon box.
Within the SETUPS menu, change the PATIENT to NEO and verify the following:
TRACE A shows a waveform sequence of moving QRS pulses without jittering.
ECG numerics show a count of 80 BPM 1 BPM.
The QRS Symbol (flashing heart) is present.
QRS HR Rate Tone is present with NO double tones.
No LEAD FAIL message is displayed in the MESSAGE AREA.
2.0 DUAL LEAD TRACE B
2.a LEAD II Setup (at 0.5mV output at 60 BPM)
Set the Patient Simulator to output a 0.5mV QRS pulse at 60BPM (NORMAL SINUS mode)
Within the ECG menu:
Set TRACE A LEAD to OFF
Set TRACE B LEAD to II
Set SCALE of 10 mm/mV
FILTER MODE set to MON
Set HR TONE SOURCE and select QRS
With the SETUPS Menu, verify PATIENT is set to ADULT.
2.b ECG TRACE B LEAD II Verification
Repeat steps 7.1.b thru 7.1.1p for TRACE B Verification.
2.c ECG TRACE B LEAD FAIL
Repeat steps 7.1.q thru 7.1.r for TRACE B LEAD FAIL Verification
2.d ECG TRACE B NEONATE SENSITIVITY
Repeat steps 7.1.s thru 7.1.t for TRACE B NEONATE SENSITIVITY Verification
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
119
REF 989803173851 APPENDIX F: TROUBLESHOOTING
ETCO2
Refer to Test Part 1.0 Initial Setup in SECTION 6 for proper Water Trap and Sampling Line Preparation.
Warm‐Up Period
The low flow CO2 requires a warm‐up period to thermally stabilize to achieve accurate gas identification
and measurement. The warm‐up period begins when the CO2 vital sign is activated. Once this happens,
the AGS will become fully operational according to the following sequence:
1. During the warm‐up period, the message “CO2 WARMING UP” will be displayed.
2. Wait during this period, as the vital sign numeric values in the CO2 Vital Sign Numerics box will
be displayed in the “No Data Available” state (‐ ‐ ‐).
3. Within 2 minutes of activation, CO2 will be able to operate at full accuracy.
Determining if there is a Leak in the System
1. Perform test step 12.2 OCCLUSION Verification in SECTION 6. If the system will not occlude,
perform the following steps:
2. Remove the sample line first and block off patient port at the Water Trap. If the system
occludes, replace sample line.
3. If a leak is still present, remove the Water Trap and block both Water Trap ports off. If the
system occludes, replace the Water Trap.
4. If a leak is still present, remove the cover off of the lower portion of the CART. Trace tubing to
the electronic box and remove tubing and block port. If the system occludes, open up the CART
Patient Connection box and verify good tubing connection between the Water Trap ports to the
Electronics box.
5. If a leak is still present, contact Technical Support.
Parameter Messages:
ETCO2
Message Probable Cause Recommended Action
CO2 OCCLUSION 1) The message “CO2 OCCLUSION” will be 1) Check the Patient Sampling Line for any
displayed when a sample line occlusion is bends, kinks or debris. If any are observed,
detected and flow is <40 ml/min. replace the Patient Sampling Line.
2) The water trap may be full of fluid. 2) Replace the water trap. If the condition
remains contact Tech Support or Invivo (Philips)‐
authorized service personnel.
CO2: HW FAIL The system ETCO2 hardware has failed. Discontinue use of the ETCO2/Agents
monitoring option and contact Tech Support or
Invivo (Philips)‐authorized service personnel.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
120
REF 989803173851 APPENDIX F: TROUBLESHOOTING
CO2 WARMING UP The message “ETCO2 WARMING UP” is Wait until ready. No Action Needed
displayed until the ETCO2 hardware is ready for
use. During that time ETCO2 readings will not
be displayed.
READJUSTING CO2 Agent hardware is performing an automatic Wait until ready. No Action Needed
ZERO Zero adjustment
ECO2: LOW FLOW The alarm message indicates a low flow 1) Check for proper sample line (Invivo REF
condition usually caused by: 94021) connected to the water trap.
1) A missing sample line or the wrong type of 2) Check to be sure the sample line is not kinked
sample line. 3) Ensure the gas exhaust port, sample line, and
2) It can also be caused by an obstruction in the water trap is not obstructed.
sample line, water trap, or at the exhaust port.
IBP
Invivo recommends using the following transducer and adapter cables with the system:
Edwards Lifesciences Transducer, Model PX260
Please contact Edwards Lifesciences for an adapter cable that is compatible with Invivo devices; and, for
additional questions, please contact your sales representative.
Note: If the transducer will not zero and an error condition occurs, verify that the transducer is
used as described in the Invasive Pressure Transducer Kit instructions. Press RETRY to
attempt zeroing again. If the transducer still does not zero, try another transducer and/or
cable; and, if condition persists, contact Technical Support or authorized service personnel.
Use only Invivo recommended pressure transducers and cables, as listed stated above.
Follow the safe use instructions that are supplied with the pressure transducer.
Parameter Messages:
IBP
Message Probable Cause Recommended Action
DONE Zeroing was successfully completed. No Action Needed
ERR: UNSTABLE 1) Unstable pressure or vibration during zero Verify there is no unstable pressure present
2) Faulty transducer connection during zero. Check the transducer for faulty
connection. If the condition remains, contact
Tech Support or Invivo (Philips)‐authorized
service personnel.
ZERO CAL ERR (LO) 1) The system has detected that the invasive Verify that a pressure transducer is connected to
pressure offset is too low for an IBP channel to the pressure channel connector. Replace
be zeroed. adapter cable and try again. If this fails,
2) No transducer is connected to the pressure exchange the transducer and retry. If the
channel connector. condition persists, contact Tech Support or
Invivo (Philips)‐authorized service personnel.
ZEROING ALL Selecting this menu initiates the zeroing all No Action Needed
PRESSURE CHANNELS pressure channels collectively.
ZEROING PRESSURE Selecting this menu initiates the zeroing of a No Action Needed
CHANNEL single invasive pressure channel.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
121
REF 989803173851 APPENDIX F: TROUBLESHOOTING
NIBP
Parameter Messages:
NIBP
Message Probable Cause Recommended Action
CALIB 1) Verify the hose and cuff are totally deflated
This message is displayed if a pressure offset is
detected in the NIBP system when a new before initiating a new NIBP measurement.
measurement is initiated. The message may 2) If the message is still displayed, then
take up to 25 seconds to be displayed. An offset disconnect the hose from the monitor and start
can be caused by the following: a new reading. If the message is still displayed
1) existing pressure in the system with the hoses disconnected, then contact Tech
2) NIBP hardware that is out of calibration. Support or Invivo (Philips)‐authorized service
personnel.
CHANGE NIBP CUFF This message is displayed for 30 seconds No action needed.
whenever the patient mode is switched
between Adult, Pediatric, or Neo as a reminder
to use the proper cuff.
CUFF LEAK 1) A leak in the cuff or hose was detected 1) Check the cuff and hoses for leaks.
2) Too much patient movement causing 2) Make sure the hose fittings are tight.
excessive pressure changes to the cuff during 3) Try to minimize patient movement during the
the measurement. measurement.
4) For assistance, contact Tech Support or Invivo
(Philips)‐authorized service personnel.
CUFF=XXX Displays the cuff pressure during the NIBP No action needed
determination.
ET=XXX Displays the elapsed time since the last NIBP No action needed
measurement was completed.
HW FAIL NIBP hardware failure or another fatal error has If the failure persists, immediately remove the
occurred. system from service and contact Invivo for
repair, as the system must not be used on any
patient requiring NIBP measurement.
LONG PRESS 1) Displayed when cuff pressure remains the 1) Verify there are no kinks or obstructions in
same during a measurement for more then 30 the cuff and hoses.
seconds 2) Usually if the LONG PRESS message is
2) Displayed if a measurement has been in displayed at the upper time limit, it means the
progress for more then 150 seconds for Adult / system was having difficulty in making the
Pediatric or 80 seconds for Neo. measurement. Check to be sure the patient
type selected is appropriate for the patient and
cuff. Be sure the cuff is fitted well and placed
properly. Try to minimize patient movement
during the measurement.
NOT INFLATING Displayed if the cuff inflation cycle is longer then 1) Check to be sure the proper cuff size is being
30 seconds for Adult / Pediatric or 6 seconds in used for the selected patient mode.
Neo 2) Make sure the hose fittings are tight.
3) Make sure there are no leaks in the cuff or
hoses.
4) For assistance contact Tech Support or Invivo
(Philips)‐authorized service personnel.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
122
REF 989803173851 APPENDIX F: TROUBLESHOOTING
OVER PRES Displayed if the cuff pressure exceeds 285 1) Check to be sure the proper cuff size is being
mmHg for Adult / Pediatric mode or 150 mmHg used for the selected patient mode.
for Neo mode. This condition can be caused by
the following: 2) For assistance contact Tech Support or Invivo
1) A hose restriction, wrong cuff size (Philips)‐authorized service personnel.
2) The patient shifting their weight onto the cuff
when the cuff pressure is near the upper limit.
RESIDUAL PRES Displayed if the NIBP system detects that cuff Check the NIBP hose and cuff hoses for kinks or
pressure remains above 20 mmHg for more then obstructions that would restrict the cuff from
150 seconds. deflating.
WRONG CUFF Displayed if the NIBP system detects that an Select the appropriate patient mode for the
incorrect cuff is being used for the selected patient and use the correct cuff size for specified
patient mode. patient mode.
Note: STANDBY MODE: Pressing the STANDBY key will place the monitor into Standby Mode.
While in Standby Mode, the monitor will continue to track and update the active patient
parameters, but 3 key features will be DISABLED:
1) All audible alarms are disabled: The fact that Alarms are disabled is indicated on the display
screen by an “X” through the Alarms Status symbol. It is also important to note that the
parameter waveform and/or numeric display continue to operate normally and will turn RED
if any active parameter violates its alarm limits.
2) Automatic NIBP measurements are suspended (if active, the current measurement will
abort).
No automatic printout is generated: When NIBP measurements are resumed, the initial reading will be
taken at the default inflation pressure that is used for all initial NIBP measurements.
If an NIBP Analyzer is available, perform the NIBP Range and Accuracy Verification as follows:
Adult Range and Accuracy Verification
Systolic Diastolic Mean Tolerance
45 15 (25) ±5mmHg
80 50 (62) ±5mmHg
120 80 (90) ±10mmHg
150 100 (115) ±10mmHg
245 185 (205) ±10mmHg
Neonatal Range and Accuracy Verification
Systolic Diastolic Mean Tolerance
45 15 (25) ±5mmHg
80 50 (62) ±5mmHg
120 80 (90) ±10mmHg
150 100 (115) ±10mmHg
190 140 (155) ±10mmHg
Note: The uncertainty specifications of the NIBP Analyzer must be added to the 3160 tolerances
for proper accuracy verification.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
123
REF 989803173851 APPENDIX F: TROUBLESHOOTING
SPO2
Patient Preparation:
1. Verify Wireless SPO2 Module is set to the correct network and is communicating with the CART.
2. Attach the appropriate SPO2 cable to the sensor.
3. If present, remove any colored nail polish from the application site.
4. Attach sensor to patient.
5. Check that the light emitter and the photodetector are directly opposite each other, as the light
from the emitter must pass through the patient’s tissue to the photodetector for proper
operation.
WARNING: • GENERAL SENSOR FIT: If a sensor is too loose, it might compromise the optimal
alignment or dislocate. If the sensor is too tight (for example, if the application site is
too large or becomes large due to edema), excessive pressure may be applied
resulting in venous congestion distal from the application site, which could lead to
interstitial edema, hypoxemia, tissue malnutrition, and inaccurate measurements.
Skin irritations may occur as a result of the sensor being attached to one location for
too long. Periodically inspect the sensor application site and change the application
site at least every four hours. Exercise care when using tape to secure the sensor, as
the stretch memory properties of most tapes can apply unintended pressure to the
sensor site easily.
• EXTREMITIES TO AVOID: Avoid placing the sensor on extremities with an arterial
catheter, intravascular venous infusion line, or inflated blood pressure cuff. Failure
to do so may result in inaccurate readings or false alarm indications.
Module Placement
1. Place the module on or near the patient as close as possible to the bore iso‐center (considering
the scan to be performed). Keep the wireless module outside the field of view.
2. Place the module as close as possible to the bore opening. (If the module can be placed outside
the bore, positioning at the iso center is not necessary.)
3. Place the module on a cushioned surface to minimize MR vibrations.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
124
REF 989803173851 APPENDIX F: TROUBLESHOOTING
WARNING: • Always shield the SpO2 sensor (for example, cover the sensor with opaque
material) from extraneous incidental light sources, as such light can cause erroneous
SpO2 readings or pulse detection errors.
• SpO2 monitoring requires the detection of valid pulses to correctly determine SpO2
and heart rate values. Any of the following items can lead to inaccuracies of the
SpO2 readings and/or prolonged measurement time: Ambient light (including
photodynamic therapy), physical movement (patient and imposed motion),
arrhythmias and/or erratic heart beats, diagnostic testing, electromagnetic
interference, electrosurgical units, dysfunctional hemoglobin, intravascular dyes,
presence of dyes or pigments at the application site, and inappropriate positioning of
the pulse oximeter probe. If questionable readings are obtained, check the patient’s
vital signs by alternate means before administering medication.
• Sensor movement, ambient light (especially strobe lights or flashing lights), or
electromagnetic interference can give unexpected intermittent readings when the
sensor is not attached to a patient. Bandage and grip sensor designs are particularly
sensitive to minimal sensor movement that might occur when the sensor is dangling,
not attached to the patient. Unapplied sensors may cause readings to be displayed
on the monitor. To avoid misdiagnosis, verify sensor is applied to patient correctly.
The 3160 Precess CART (REF 865323) does not contain a SpO2 board and ninety‐five
Note:
percent of the SpO2 failures are the SpO2 module or sensor.
Parameter Messages:
SPO2
Message Probable Cause Recommended Action
BAD PROBE The monitor has sensed a shorted or open Try another SPO2 sensor and cable. If problem
connector in the sensor or cable. persists, contact Tech Support or Invivo (Philips)‐
qualified service personnel for repair.
ERRATIC The SpO2 sensor is not properly applied to the 1) Reposition probe.
patient, is not properly positioned, or the probe 2) Replace probe.
is faulty. 3) Contact Tech Support or Invivo (Philips)‐
qualified service personnel for repair
HW FAIL A hardware or other fatal error has occurred in Try another Wireless SpO2 Module. If the failure
the SpO2 hardware inside the SpO2 Wireless persists, remove the system from service
Module or in the CART. immediately and contact Tech Support or Invivo
(Philips)‐qualified service personnel for repair.
The system must not be used on any patient
that requires SpO2 measurement.
INTRFERNCE The probe light sources may not be aligned with 1) Check to see if patient is moving, especially if
the probe light receivers, or the probe may be the motion is occurring at the monitored site.
poorly positioned. 2) Ensure that the probe is positioned such that
the emitters or photodiodes are not exposed to
excessive levels of ambient light.
3) Try a different limb or site.
4) Try using a different probe.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
125
REF 989803173851 APPENDIX F: TROUBLESHOOTING
LOW PERFUSION The tissue at the site may be too opaque and/or If the sensor is positioned on the finger, check
thick. the fingernails for nail polish, long or artificial
fingernails. Remove any fingernail polish
completely. For artificial nails, try another
location, like a toe.
NO PROBE No probe is connected to the wireless module, Check probe connection to the wireless module.
or the probe is not properly connected to the If connection appears sound, try another probe.
module.
NON‐PULSAT The patient pulse is too weak for the system to 1) Check probe position and alignment on the
report reliable SpO2 saturation and pulse patient and re‐position or re‐apply as necessary.
measurements. 2) Try a different limb or site.
NOISE Excessive patient motion or electrical 1) Check to see if patient is moving, especially if
interference. the motion is occurring at the monitored site.
2) Ensure that the probe is positioned such that
the emitters or photodiodes are not exposed to
excessive levels of ambient light.
PROBE OFF The SpO2 sensor is not properly applied to the Check probe position and alignment on the
patient such that a recognizable SpO2 signal patient and reposition or re‐apply as necessary.
cannot be detected, or the probe has simply
come off of the patient.
PULSE? The probe may not be applied optimally, or the 1) Check probe position and alignment on the
tissue at the applied site may too opaque. patient and re‐position or re‐apply as necessary.
2) Try a different limb or site.
SEARCHING The system is searching for a good pulse. The If the probe was just applied, give the system
probe was just applied to the patient, or the time to lock onto a good pulse. This usually
probe has shifted position since being applied. takes less than 20 seconds. Otherwise, check
the probe position and reposition if necessary.
WRONG PROBE The probe connected to the module is wrong. Attach a correct SpO2 sensor and cable to the
module.
The 3160 Precess (865323) does not contain a SpO2 board and ninety‐five percent of the
Note:
SpO2 failures are the SpO2 module or sensor.
Accuracy Check:
If an SPO2 Simulator is available, verify the accuracy of Oxygen Saturation Value with Invivo probes as
follows:
Oxygen Saturation Tolerance
90‐100% ±2
80‐90% ±2.2
70‐80% ±2.5
60‐70% ±3
Note: The uncertainty specifications of the SPO2 Simulator must be added to the 3160
tolerances for proper accuracy verification.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
126
REF 989803173851 APPENDIX F: TROUBLESHOOTING
TEMPERATURE
Patient Preparation:
1. Inspect the temperature probe for damage.
2. Determine the application site in the auxilary location, then thoroughly clean that site.
3. Position the probe at the application site and place FiberTEMP Sensor Applicator over the probe.
4. Check that the light emitter and the photodetector are directly opposite each other, as the light
from the emitter must pass through the patient’s tissue to the photodetector for proper
operation.
Probe Placement/Connection
1. Position the probe at the application site and place FiberTEMP Sensor Applicator over the probe.
2. Insert the probe into the Surface Temperature Probe connection until a click is heard.
3. Allow time for the temperature to stabilize.
Note: The accuracy of the thermometer portion of this equipment can be verified by using a
temperature bath.
The minimum measuring time to obtain accurate readings at a specific body site is 130
seconds.
Routinely inspect cables and sensor assemblies for cracks, holes, tears, cuts, etc., that can
affect system accuracy.
Always discard defective temperature probes.
Parameter Messages:
TEMP
Message Probable Cause Recommended Action
UND The temperature has fallen below 20.0°C Check the patient condition. If the condition
(69.8°F) or, the probe, the temperature module remains, contact Tech Support or Invivo
or both have become inoperative. (Philips)‐authorized service personnel.
OVR The temperature has risen above 44.0°C Check the patient condition. If the condition
(111.2°F) or, the probe, the temperature module remains, contact Tech Support or Invivo
or both have become inoperative. (Philips)‐authorized service personnel.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
127
REF 989803173851 APPENDIX F: TROUBLESHOOTING
KEYPAD FUNCTIONS
Verify that when pressing the FREEZE button once, that
TRACE A freezes and a blue box frames the waveform.
Pressing the FREEZE button once again unfreezes TRACE A
and clears the blue frame.
(N/A if Recorder option is not installed). Verify that when the
EVENT MARK button is pressed that a marker is printed on
There is no pop‐up window.
the ECG recorder strip when the recorder is running. (If the
printer is not running, pressing this key has no effect).
Verify that when pressing the ZERO ALL button, a dialog box is
displayed to alert the operator that no invasive pressures are
enabled.
Verify that when pressing the MONITOR SETUP button, that
the SETUP menu is displayed. Press the NORMAL SCREEN
and the SETUPS menu is removed from the display.
Verify that when pressing the ALARMS SETUP button, that
the ALARMS menu is displayed. Press the NORMAL SCREEN
and the ALARMS menu is removed from the display.
Verify that when pressing the PRINTER SETUP button, that
the PRINTER menu is displayed. Press the NORMAL SCREEN
and the PRINTER menu is removed from the display.
From CRD
From CART
Connect a NIBP cuff to the NIBP ports and verify that when
pressing the NIBP START/STOP button, that the monitor
There is no pop‐up window.
attempts to take a NIBP measurement. Pressing the NIBP
START/STOP will cause to NIBP pump to turn off.
Verify that when pressing the TRENDS button, that the
HISTORY menu is displayed. Press the NORMAL SCREEN and
the HISTORY menu is removed from the display.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
128
REF 989803173851 APPENDIX F: TROUBLESHOOTING
Verify that when pressing the NIBP INTERVAL button, that the
INTERVAL menu is displayed. Press the NORMAL SCREEN and
the INTERVAL menu is removed from the display.
Verify that when pressing the CLEAR TRENDS button, that a
WARNING dialog box appears. Use the Rotary knob to select
YES. Verify that the WARNING prompt is removed from the
display and all trend and patient data are erased.
Verify that when pressing the NIBP STAT button, that the
monitor attempts to take a NIBP measurement. Pressing the There is no pop‐up window.
NIBP START/STOP will cause to NIBP pump to turn off.
(N/A if Recorder option is not installed). Verify that when the
PRINT button is pressed that the recorder on the left side of
the CRD begins to print. Pressing the PRINT button again
There is no pop‐up window.
from the CRD will cause the Recorder to stop printing after
printing the Patient Information area. If pressing PRINT from
the CART , the CRD will run the full print cycle
Verify that pressing the NORMAL SCREEN button returns the
monitor to the “Normal Screen” when any menu is displayed.
(Pressing this key has no effect if no menu is displayed.) There is no pop‐up window.
Verify that all audible alarms are disabled, the disabled alarms
are indicated on the display screen by an “X” through the bell
shaped Alarm Status Symbol, and active NIBP automatic
measurements are suspended. Press the STANDBY button a
second time and verify that all audible alarms are enabled,
the “X” through the bell shaped Alarm Status Symbol is
removed, and active NIBP automatic measurements are
resumed after selection of the NIBP START/STOP button.
Verify that pressing this ALARM SILENCE button stops the ALARM
alarm tone when an alarm is active. (Pressing this key has no SILENCED
effect when audio alarms are disabled.) or
SOUND
ON HOLD
xxx
(x = a number from 0 to 9)
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
129
REF 989803173851 APPENDIX F: TROUBLESHOOTING
COMMUNICATION
Key Component locations to use for Communication Troubleshooting
Step Action
1. Apply power to the CART, CRD and insert batteries into modules. Turn on the CART and DCU
and insert batteries into the modules. Verify that all of the Power LEDs are illuminated
SOLID and are not blinking. (Only the CRD & module LEDs are capable of blinking)
2. After the CART and CRD are fully booted, verify that the network numbers in the lower right
corner of the display are the same and that the Power Icons for the CART, CRD, and modules
are not X’d out.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
130
REF 989803173851 APPENDIX F: TROUBLESHOOTING
3. Example of the CART, CRD and modules are all communicating with each other.
4. Example of the CART not communicating to a CRD or the modules.
Communication loss here is indicated by “Xs” through the Remote Print Icon, SPO2 and ECG
Icons along with loss of the associated SPO2 and ECG waveforms and numerics.
5. If the voltage measured is > +3.3 Vdc (voltage reading good), reinstall the batteries in the
transmitter modules.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
131
REF 989803173851 APPENDIX F: TROUBLESHOOTING
Examples of Waveform Gaps:
Multiple Parameters indicates CART or CART
to CRD comm loss
Examples of the Display showing different communication scenarios:
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
132
REF 989803173851 APPENDIX F: TROUBLESHOOTING
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
133
REF 989803173851 APPENDIX F: TROUBLESHOOTING
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
134
REF 989803173851 APPENDIX F: TROUBLESHOOTING
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
135
REF 989803173851 APPENDIX F: TROUBLESHOOTING
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
136
APPENDIX G—CRD DATA OUTPUT
Introduction
The CRD has the ability to send vital sign data over an RS232 null serial communications link. This can be
accomplished by using the DB9 connector (COM6/COM2) located inside the rear access panel of the
CRD. When the user connects a serial cable, a stream of data shall be sent to a computer that records
the parameter data stream.
Protocol: 9600 Baud, 8 data bits, no parity, and 1 stop bit, no flow control
All values are in ASCII character format, whether the data is textual or numeric in nature. Each data
item is separated from the next by a comma and contains no extraneous spaces. The Data Output items
are in the order, format, and units as given in the table below. Each of the items in the table are sent as
a single record at the rate of once per second (1Hz).
Month/Day/Year, Hour:Minute:Second, Heart Rate, Heart Rate Source, IP1 Systolic, IP1 Mean,
IP1 Diastolic, IP2 Systolic, IP2 Mean, IP2 Diastolic, NIBP Systolic, NIBP Mean, NIBP Diastolic,
SpO2, RESP Rate, EtCO2, Inspired CO2, N2O, FiO2, Primary Expired Agent %, Primary Inspired
Agent %, Primary Agent Type (HAL,ISO,ENF,SEV,DES), TEMP
Values that can have selectable units (such as invasive pressures in kPa or mmHg) are sent in the units
that are currently selected. Non‐numeric data is sent as it appears on the display of the CRD; it will not
be trimmed of any leading or trailing blanks. Unless noted, the numeric data that is output have the
same format and value as what is displayed on the CRD.
There are two different formats that can be selected through the SYSTEM CONFIG menu for the serial
data output. The difference between the two formats is primarily how they handle over and under
conditions.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
137
REF 989803173851 APPENDIX G: CRD DATA OUTPUT
The INVIVO format prints one number outside of the maximum or minimum number in the range when
the display shows OVR and UND. If the parameter has no value to display (displayed as “‐‐‐“ in the menu
box on the display) or when the parameter is turned off or not installed, the output will be “0” for the
value (0.0 for those with floating points).
The OVR‐UND format prints an O after the upper range value and a U after the lower range value when
the display show OVER or UND. If the parameter has no value to display (displayed as “‐‐‐“ in the menu
box on the display) or when the parameter is turned off or not installed, the output will be “‐” for the
value.
CRD Data Output Format
Item
Data Item Format Units Notes
#
mm/dd/yyyy
Where as mm=the month, dd=the day,
1 Date None
yyyy=the year. Months and days are
preceded by a leading 0 if <10.
hh:mm:ss
2 Time Where as hh=hours (in Military format of None
00 to 23), mm=minutes, ss=seconds.
3 Heart Rate Integer BPM
4 Heart Rate Source Character string None
5 P1, Systolic Number (Integer for Floating Point) mmHg or kPa
6 P1, Mean Number (Integer for Floating Point) mmHg or kPa
7 P1, Diastolic Number (Integer for Floating Point) mmHg or kPa
8 P2, Systolic Number (Integer for Floating Point) mmHg or kPa
9 P2, Mean Number (Integer for Floating Point) mmHg or kPa
10 P2, Diastolic Number (Integer for Floating Point) mmHg or kPa
11 NIBP, Systolic Number (Integer for Floating Point) mmHg or kPa
12 NIBP, Mean Number (Integer for Floating Point) mmHg or kPa
13 NIBP, Diastolic Number (Integer for Floating Point) mmHg or kPa
14 SPO2 Integer %
15 RESP Rate Integer Breaths/Min
16 CO2 Integer mmHg
17 Inspired CO2 Integer mmHg
18 N2O Integer %
19 FiO2 Integer %
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
138
REF 989803173851 APPENDIX G: CRD DATA OUTPUT
Sample of INVIVO Serial Data (only ECG, SPO2, FiO2 displaying readings):
01/28/2011,16:30:37,60,ECG,0,0,0,0,0,0,0,0,0,99,0,0,0,0,21,0.0,0.0,X,0.0
01/28/2011,16:30:38,60,ECG,0,0,0,0,0,0,0,0,0,99,0,0,0,0,21,0.0,0.0,X,0.0
01/28/2011,16:30:39,60,ECG,0,0,0,0,0,0,0,0,0,99,0,0,0,0,21,0.0,0.0,X,0.0
01/28/2011,16:30:40,60,ECG,0,0,0,0,0,0,0,0,0,99,0,0,0,0,21,0.0,0.0,X,0.0
Sample of OVR‐UND Serial Data (only ECG (over), SPO2, FiO2 displaying readings):
01/28/2011,16:30:42,250O,ECG,60,ECG,‐,‐,‐,‐,‐,‐,‐,‐,‐,99,‐,‐,‐,‐,21,‐,‐,‐,‐
01/28/2011,16:30:43,250O,ECG,60,ECG,‐,‐,‐,‐,‐,‐,‐,‐,‐,99,‐,‐,‐,‐,21,‐,‐,‐,‐
01/28/2011,16:30:44,60,ECG,60,ECG,‐,‐,‐,‐,‐,‐,‐,‐,‐,99,‐,‐,‐,‐,21,‐,‐,‐,‐
01/28/2011,16:30:45,60,ECG,60,ECG,‐,‐,‐,‐,‐,‐,‐,‐,‐,99,‐,‐,‐,‐,21,‐,‐,‐,‐
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
139
REF 989803173851 APPENDIX G: CRD DATA OUTPUT
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
140
APPENDIX H—DETERMINING SYSTEM CONFIGURATION
Visual Inspection
Step Action
1. Check the keypad overlay and menus for language that the CART is configured to.
2. If the CART can boot, check the lower left corner of the display for the network number.
If the CART is not bootable, check the wireless modules for network setting.
3. Using the CART Patient Connections diagram below, determine what optional parameters
are installed. NOTE: All basic CART configurations with have NIBP ports.
Item# Description Comments
The water trap is used when a Gas Option is installed. The Gas
Gas Input Port and
1 Input Port allows for measurement of the optional EtCO2/
Water Trap
Anesthetic Agent patient parameter.
2 NIBP Ports The NIBP ports provide for the connection of the NIBP patient cuff.
EtCO2 Zero The EtCO2 Zero port is used for zeroing of the optional
3
Connection EtCO2/Anesthetic Agent Gas module.
P1/D1 and P2/D2 IBP The IBP ports provide for the connection of two IBP probes for
4
Connections taking patient invasive blood pressure measurements.
The Temperature port provides for the connection of a FISO
Temperature
5 Temperature probe for taking patient surface temperature
Connector
measurements.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
141
REF 989803173851 APPENDIX H: DETERMINING CONFIGURATION
Revision Information
Step Action
4. Press the SETUPS button on the CART display keypad. Scroll down and select SERVICE(BIO‐
MED), then select S/W REV menu.
5. In the REVISION INFORMATION window below, the information next to the areas highlighted
in RED is required when calling in for Technical Support and/or the CART is being sent in for
repair and a loaner is requested.
Under GAS, if “PEC” is displayed, then the CART has the Low‐Flow ETCO2 option installed.
Note:
If “AR” is displayed, then the Anesthetic Agents option is installed.
The WPU software “WPUC__” will vary depending on the last time the CART software was
Note:
upgraded.
CRD
Visual Inspection
Step Action
1. Check the keypad overlay and menus for language that the CRD is configured to.
2. On the left side of the CRD, is there a recorder installed?
3. If the CRD can boot, check the lower left corner of the display for the network number.
If the CRD is not bootable, check the CART or wireless modules for network setting.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
142
REF 989803173851 APPENDIX H: DETERMINING CONFIGURATION
Revision Information
Step Action
4. Press the SETUPS button on the CRD display keypad. Scroll down and select SERVICE(BIO‐
MED), then select S/W REV menu.
5. In the REVISION INFORMATION window below, the information next to the areas
highlighted in RED is required when calling in for Technical Support and/or the CRD is being
sent in for repair and a loaner is requested.
The DCU software “DCUC__” will vary depending on the last time the CRD software was
Note:
upgraded.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
143
REF 989803173851 APPENDIX H: DETERMINING CONFIGURATION
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
144
APPENDIX I—DISASSEMBLY
CART
The 3160 Patient Monitors contain Static Sensitive circuits. Proper handling procedures must be
followed when touching any Printed Circuit Board (PCB) as static voltages usually present on clothing
and personnel present great risk of damage to the circuits.
All Service Procedures MUST be performed by Properly Grounded Personnel at a Static‐Free Work
Station outside of the MR system room.
Step Action
1. Disconnect the AC line Cord from the AC Power Adapter mounted underneath the CART and
remove the 9989803169491 batteries from the CART.
2. Disconnect the DC Cord. Loosen the two (2) captive screws securing the O2 cell plastic
cover. Remove cover plate.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
145
REF 989803173851 APPENDIX I: DISASSEMBLY
3. Lay unit on its back and remove the outer 4 small screws on the underside of CART base,
next to the wheels. Bring the CART back upright.
4. Lift cover off of the base and put aside.
5. To open up the electronic box, remove the 25 screws around the perimeter of the
Electronics Assembly (including the screws holding the plastic antenna holder).
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
146
REF 989803173851 APPENDIX I: DISASSEMBLY
CART Key Component Locations
# Description 12NC
1 Diversity Antenna Boards (Qty. 2) 453564155461
2 Radio Boards (Qty. 2) 453564060171
3 Radio (HE97B) 453564151931
4 FISO Temperature Assy 453564060191
5 External I/O (located behind NIBP / GAS Assy) 453564060241
6 NIBP Assy 453564088651
7 Location of either Agents Assy 453564082991
or or
Low‐Flow ETCO2 Assy 453564153401
8 Power Supply 453564229031
9 USB Module (under GAS Assy) 453564060561
10 NIBP Transducer 453564160681
11 Motherboard (mounted on chassis floor) 453564206611
12 Antenna 453564060151
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
147
REF 989803173851 APPENDIX I: DISASSEMBLY
CART Patient Connection Disassembly
Step Action
1. Disconnect the AC line Cord from the AC Power Adapter mounted underneath the CART
and remove the 9989803169491 batteries from the CART.
2. Remove the 4 screws on the backside of the “PCU” and remove cover.
3. Remove the 4 screws on the inside. Be careful since the front panel might fall forward. (See
“Key Component Locations” picture)
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
148
REF 989803173851 APPENDIX I: DISASSEMBLY
CART Patient Connections Key Component Locations
# Description 12NC
1. IBP Quiet Box 453564172771
2. Water Trap Mount 453564060001
3. IBP Connector Assy 453564137941
4. Temperature Data Cable 453564215151
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
149
REF 989803173851 APPENDIX I: DISASSEMBLY
CART Display Disassembly
Step Action
1. Disconnect the AC line Cord from the AC Power Adapter mounted underneath the CART and
remove the 9989803169491 batteries from the CART.
2. Remove the 9 parameter screws on the rear of the CART Display
3. Remove the screw under the front of the bezel.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
150
REF 989803173851 APPENDIX I: DISASSEMBLY
4. Roll CART up against a work bench or table of appropriate height and gently lay the front
bezel assembly on a protected surface on the tabletop.
CART Display Key Component Locations
# Description 12NC
1 Encoder Switch 453564186591
2 LCD Panel (under shield) 453564196541
3 Upper LVDS 453564177091
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
151
REF 989803173851 APPENDIX I: DISASSEMBLY
CRD
CRD Disassembly
Step Action
1. Disconnect the AC Power Adapter from the rear of the CRD.
2. Open recorder door (if printer is installed) and remove paper and loosen the 2 captive
screws inside recorder and slide it out.
3. Remove the 10 parameter screws on the rear of the CRD.
4. Split the CRD into two and lay pieces opposite from each other.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
152
REF 989803173851 APPENDIX I: DISASSEMBLY
CRD Key Component Locations
# Description 12NC
1 USB Module 453564060561
2 Motherboard 453564206621
3 Motherboard to Power Supply Interface 453564155601
4 Keypad Interface 453564060481
5 Encoder Switch 453564060451
6 LCD Panel 453564196541
7 Radio (HE97B) 453564151931
8 LCD Panel Adapter 453564196551
9 Antenna Cable 453564060671
10 Printer 453564060741
11 Opto Coupler 453564060721
12 Power Supply 453564229031
13 Printer Energy Storage Assy 453564085431
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
153
APPENDIX J—INTERCONNECT DIAGRAMS
Interconnect Wiring Diagrams
Drawing Number Description Page
D‐865323‐90007, Sheet 1 of 3 CART with Agents, IBP and TEMP 155
D‐865323‐90007, Sheet 2 of 3 CART with ETCO2, IBP and TEMP 156
D‐865323‐90007, Sheet 3 of 3 CART Display and Patient Connections 157
D‐865485‐90001. Sheet 1 of 2 CRD with Printer 158
D‐865485‐90001. Sheet 2 of 2 CRD without Printer 159
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL, WITHOUT PERMISSION, IS A
VIOLATION OF LAW.
154
REF 989803173851 APPENDIX J: INTERCONNECT DIAGRAMS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL, WITHOUT PERMISSION, IS A
VIOLATION OF LAW.
155
REF 989803173851 APPENDIX J: INTERCONNECT DIAGRAMS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL, WITHOUT PERMISSION, IS A
VIOLATION OF LAW.
156
REF 989803173851 APPENDIX J: INTERCONNECT DIAGRAMS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL, WITHOUT PERMISSION, IS A
VIOLATION OF LAW.
157
REF 989803173851 APPENDIX J: INTERCONNECT DIAGRAMS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL, WITHOUT PERMISSION, IS A
VIOLATION OF LAW.
158
REF 989803173851 APPENDIX J: INTERCONNECT DIAGRAMS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL, WITHOUT PERMISSION, IS A
VIOLATION OF LAW.
159
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL, WITHOUT PERMISSION, IS A
VIOLATION OF LAW.
160
APPENDIX K—SERVICE PARTS
CART
Non‐Exchange Service Parts
CART SERVICE PARTS
Part Number Part Number
Description
(12NC/CMS #) (12NC/CMS #)
404019 453564059981 NIBP, 5/16 THD‐1/8 BARB AS
453564082991 453564082991 AION MR MULTIGAS ANALYZER
453564085411 453564085411 Assembly, Battery Interface, WPU, 3160/P
453564087661 453564087661 LABEL,RADIO NETWORK ID CHAN. 1, NF, 3160
453564087671 453564087671 LABEL,RADIO NETWORK ID CHAN. 2, NF, 3160
453564087681 453564087681 LABEL,RADIO NETWORK ID CHAN. 3, NF, 3160
453564087691 453564087691 LABEL,RADIO NETWORK ID CHAN. 4, NF, 3160
453564087701 453564087701 LABEL,RADIO NETWORK ID CHAN. 5, NF, 3160
453564088651 453564088651 Assy, NIBP Pneumatics, WPU
453564095931 453564095931 CABLE, GAS ANALYZER, WPU
453564098551 453564098551 CAB, GROUND, AB280, WPU 3160/P
453564122151 453564122151 GASKET,EMI,CABLE,CART
453564153401 453564153401 ETCO2 Assembly
453564155461 453564155461 PCA,WPU DIVERSITY ANTENNA, 3160P
453564155601 453564155601 PCA, AB160 to AB280 Interface Assem.,DCU
453564159211 453564159211 ASSY.SHIELD BOX,POWER,WPU,3160P
453564172771 453564172771 ASSY,BOX,IBP,PCU,3160
453564177081 453564177081 PCA,LVDS Lower
453564177091 453564177091 PCA,LVDS Upper
453564177481 453564177481 Cable, Center Pole
453564177491 453564177491 External DC Power Cable
453564177521 453564177521 CBL,RIBBON,24P,.025 CTRS,15.00
453564186101 453564186101 CABLE, COAXIAL Aircom, 50 Ohm (100ft)
453564186591 453564186591 ENCODER,OPTICAL,24POS,PB,MINIw/8"cable
453564186671 453564186671 DOOR,CONN.PANEL,WPU
453564189361 453564189361 DISPLAY WINDOW, LCD, DCU
453564196541 453564196541 LCD, 12.1", DCU
453564196691 453564196691 OVERLAY,KEYPAD,MR CART, ENG
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
161
REF 989803173851 APPENDIX K: SERVICE PARTS
453564197511 453564197511 OVERLAY, KEYPAD,MR DCU,GERMAN
453564197531 453564197531 OVERLAY,KEYPAD, MR DCU, FRENCH
453564197551 453564197551 OVERLAY,KEYPAD,MR DCU, SPANISH
453564197591 453564197591 OVERLAY, KEYPAD, MR DCU, DANISH
453564197621 453564197621 OVERLAY,KEYPAD, MR DCU, ITALIAN
453564197641 453564197641 OVERLAY, KEYPAD, MR DCU, PORTUGUESE
453564197931 453564197931 CABLE, ADAPTER BOARD, LCD
453564198921 453564198921 POLE,SUPPORT,3160C‐
453564199501 453564199501 SHIPPING CONTAINER,CART,3160
453564200831 453564200831 OVERLAY, KEYPAD, MR DCU, DUTCH
453564200851 453564200851 OVERLAY,KEYPAD,MR DCU, NORWEGIAN
453564200891 453564200891 OVERLAY,KEYPAD,MR DCU,SWEDISH
453564205311 453564205311 OVERLAY,WPU,3160
453564206611 453564206611 PCA,MOTHERBOARD,CART
453564215151 453564215151 CABLE, FISO, POLE, 3160C‐
453564217021 453564217021 ASSY.SHIELD BOX,POWER,WPU,3160C‐
453564218661 453564218661 CABLE, FISO, WPU, 3160C‐
453564228001* 453564228001* WIRELESS ECG MODULE
453564228011* 453564228011* WIRELESS SPO2 MODULE
453564229031 453564229031 PCA,POWER SUPPLY 3160 Family
9010F 989803152641 CAL GAS,AEROSOL CO‐2
9023 989803152891 ASSY,3.7V BATTERY CHARGER,3160
9059 989803152871 ASSY,PSSIVE ANT.SYSTEM,2.4GHZ
9065 989803152881 BATTERY,3.7V,WRLS.PAT.MDLE.
94018 989803152661 KIT,SAMPLE,AGENTS,3160
94021 989803152541 KIT,SAMPLE,ETCO2,3160
989803162051 989803162051 Oxygen (O2) Sensor
989803162961 989803162961 Oxygen (O2) Sensor, Installation Tool
989803168201 989803168201 MR Compatible Power Converter
989803168211 989803168211 North American Line Cord
989803169491 989803169491 BATTERY,MRI,14.8V,5.08 AH
AB195 453564060171 PCA,DUAL RADIO,WPU,3160
AB211 453564060241 PCA,EXTRNL I/O WPU 3160
AB227 453564160681 PCA,NIBP TRANSDUCER,WPU,3160
AB228 453564060561 PCA,USB MODULE,DCU,3160
AB231 453564060631 PCA,USB ADAPTER,DCU/WPU,3160
AB249 453564137941 PCA,CONN.ADPTR,IBP,3160
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
162
REF 989803173851 APPENDIX K: SERVICE PARTS
AB251A 453564060261 PCA,LOW FLOW ETCO2 MODULE,3160
AC474 453564060531 CAB,RIBBON,16P,.050 CTRS,2
AC479E3 453564137301 CAB,F.O.,IBP,WPU,3160
AC524 453564060511 CAB,RIBBON,26P,.039 CTRS,3.50
AC529B 453564137321 CAB,RIBBON,30P,.025 CTRS,21.00
AC529C 453564137211 CAB,RIBBON,30P,.025 CTRS,15.00
AC529D 453564137251 CAB,RIBBON,30P,.025 CTRS,4.50
AC538 453564060401 CAB,FILTER,PWR.SWITCH,DCU,3160
AC539 453564060641 CAB,USB PORT,DCU/WPU,3160
AC543 453564060671 CAB,ANTENNA,15.00 LG.
AC553 453564138111 CAB,DATA,TEMP MODULE, WPU, 3160
AC560 453564137591 CAB,BATTERY POWER,WPU,3160
AC562 453564137601 CAB,GATING,WPU,3160
AC566 453564134451 CAB,EXT.POWER INPUT,WPU,3160
AC574 453564134461 CABLE,GATING,FILTERED,WPU,3160
AC579 453564137241 CABLE,FIBER OPT,TEMP,WPU,3160
AC580 453564138231 CABLE, F.O., IBP, PCU, 3160
AC602 453564060041 CABLE,INTERCONNECT,IBP,3160
AS222 453564136641 ASSY,CONN.BATTERY,WPU,3160
FU39 453564060691 FUSE,5AMP,ATO BLADE
H096 453564134471 MOUNT,CABLE TIE,ADHESIV BA
H162‐021SS 453564136931 STRIP,RF,PNL.GSKT,1.995
H162‐023CC 453564060371 STRIP,RF,PNL.GSKT,2.185,CH
H162‐027SS 453564136941 STRIP,RF,PNL.GSKT,2.565
H162‐056CC 453564060361 STRIP,RF.PNL.GSKT,5.32,CHM
H162‐085CC 453564060381 STRIP,RF,PNL.GSKT,8.075,CHMF
H162‐112A 453564060341 STRIP,RF,GSKT,10.64,CHMF C
H162‐138A 453564060351 STRIP,RF,GSKT,13.11,CHMF,C
H162‐144A 453564060331 STRIP,RF,GSKT,13.68,CHMF,C
H163 453564060571 DISPLAY WINDOW,SHLDED,DCU,
HC19 453564177771 TIE,CAB,3.1"
HC20 453564134131 CAB,CLAMP,NYLON
HC40 453564137661 CLAMP,CABLE,ADJUSTABLE,SNA
HE107 453564138761 CONNECTOR, N‐CONN, MALE, COAX
HE109 453564138771 CONNECTOR, BNC, MALE, COAX
HE113 453564060191 PCA,TEMP.SENSOR,FIBER OPTI
HE124 453564060421 SPEAKER,PIEZO,105DB
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
163
REF 989803173851 APPENDIX K: SERVICE PARTS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
164
REF 989803173851 APPENDIX K: SERVICE PARTS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
165
REF 989803173851 APPENDIX K: SERVICE PARTS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
166
REF 989803173851 APPENDIX K: SERVICE PARTS
CRD
Non‐Exchange Service Parts
CRD SERVICE PARTS
Part Number Part Number
Description
(12NC/CMS #) (12NC/CMS #)
453564085421 453564085421 CABLE, PRINTER ENERGY STORAGE, DCU, 3160
453564085431 453564085431 ASSEMBLY, PRINTER ENERGY STORAGE,DCU
453564085831 453564085831 SHIPPING CONTAINER, DCU, 3160
453564087661 453564087661 LABEL,RADIO NETWORK ID CHAN. 1, NF, 3160
453564087671 453564087671 LABEL,RADIO NETWORK ID CHAN. 2, NF, 3160
453564087681 453564087681 LABEL,RADIO NETWORK ID CHAN. 3, NF, 3160
453564087691 453564087691 LABEL,RADIO NETWORK ID CHAN. 4, NF, 3160
453564087701 453564087701 LABEL,RADIO NETWORK ID CHAN. 5, NF, 3160
453564094091 453564094091 CASTING,PANEL,REAR,DCU,3160C
453564155601 453564155601 PCA, AB160 to AB280 Interface Assem,DCU
453564186661 453564186661 OVERLAY, KEYPAD,CRD, ENGLISH
453564189361 453564189361 DISPLAY WINDOW, LCD, DCU
453564196541 453564196541 LCD, 12.1", DCU
453564196551 453564196551 PCA, ADAPTER BOARD, LCD
453564197521 453564197521 OVERLAY, KEYPAD,CRD,GERMAN
453564197541 453564197541 OVERLAY, KEYPAD, CRD, FRENCH
453564197561 453564197561 OVERLAY,KEYPAD,CRD, SPANISH
453564197611 453564197611 OVERLAY, KEYPAD, CRD, DANISH
453564197631 453564197631 OVERLAY, KEYPAD, CRD, ITALIAN
453564197651 453564197651 OVERLAY, KEYPAD, CRD, PORTUGUESE
453564197931 453564197931 CABLE, ADAPTER BOARD, LCD
453564200841 453564200841 OVERLAY, KEYPAD, CRD, DUTCH
453564200861 453564200861 OVERLAY,KEYPAD,CRD, NORWEGIAN
453564200901 453564200901 OVERLAY, KEYPAD, CR, DCU, SWEDISH
453564206621 453564206621 PCA, MOTHERBOARD, CRD
453564215011 453564215011 PANEL, FRONT, CR DCU, 3160C‐
453564229031 453564229031 PCA,POWER SUPPLY 3160 FAMILY
989803168211 989803168211 North American Line Cord
AB181 453564060481 PCA,KEYBOARD INTERFACE,3550
AB228 453564060561 PCA,USB MODULE,DCU,3160
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
167
REF 989803173851 APPENDIX K: SERVICE PARTS
AB231 453564060631 PCA,USB ADAPTER,DCU/WPU,3160
AB238 453564060651 PCA,COMM.PORT,DCU/WPU,3160
AB240 453564060721 PCA,OPTO.COUPLER,DCU,3160
AB241 453564060711 PCA,AR42 RCRDR.INTRFC,DCU,
AC474 453564060531 CAB,RIBBON,16P,.050 CTRS,2
AC529C 453564137211 CAB,RIBBON,30P,.025 CTRS,15.00
AC539 453564060641 CAB,USB PORT,DCU/WPU,3160
AC543 453564060671 CAB,ANTENNA,15.00 LG.
FE10 453564060621 FOOT,BLACK,PUSH RIVOT,.354H
H166 453564138531 PLUNGER,MOUNTING FOOT,3160
HC19 453564177771 TIE,CAB,3.1"
HE61 453564060151 ANTENNA,2.4GHZ,RA,MALE
HE124 453564060421 SPEAKER,PIEZO,105DB
HE97B 453564151931 TRANSCEIVER,2.4 GHZ,460 KB
HM79BY1 453564222771 KNOB, 3160
HM90A1 453564060411 BOX,SPEAKER,3160DCU
HM90AF 453564220491 BRKTBRKT,PRINTER COVER, DCU, 3160
HM90AG 453564220211 COVECOVER,PRINTER HOLE, DCU, 3160
HM90AM 453564137691 BRKT,USB SUPPORT,WPU,DCU,3160
HS42 453564139531 STANDOFF,HEX,F/F,4‐40 X.5
HS77 453564177901 STNDF,.25 HEX,M/F,4‐40X.875,BR
HS87 453564136631 STANDOFF,SCW.MOUNT,CIRCUIT
HT18 453564060741 PRINTER,THRM,GSI GROUP,AR42
L2036A 453564060751 LABEL,PRINTER DOOR,LT. GRA
L2100A 453564136601 SWITCHPAD,MEMBRANE,3160
M007 453564138431 ADHESIVE,LOCTITE 262,RED,T
M050 453564138561 ADHESIVE,LOCTITE 425,BLU,A
N002N 453564139301 NUT,HEX,#4‐40,SS,NM
N009 453564136361 NUT,HEX,#4‐40,NY
NS111N 453564139541 SCR,#6‐32X 1/2LG,FHMS‐XR,N
NS185N 453564137061 SCR,CAPT,#6‐32X9/16LG,PH‐X
NS49N 453564137071 SCR,#2‐56 X 1/4 LG,PHMS‐XR
NW11N 453564133441 WASHER,FLAT,#6X.312X.048,S
S035 453564060451 ENCODER,OPTICAL,24 POS,PB,
WT01 453564136651 HEAT SHRINK 1/8" ID BLACK ‐ 1 pce = 4ft
WT04 453564136761 HEAT SHRINK 3/32" ID BLACK ‐ 1 pce = 4ft
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
168
REF 989803173851 APPENDIX K: SERVICE PARTS
System Preventative Maintenance Parts & Schedule
The following Preventative Maintenance parts are available.
Invivo
(12NC/CMS #) Description Qty
REF
9010F 989803152641 CAL GAS,AEROSOL CO‐2 REF 9010F (if any gas option is installed) 1
HP169 453564060011 WATER TRAP,DSPSBL,AGENTS,3160 (if Agent option is installed) 1
94018 989803152661 KIT,SAMPLE,AGENTS,3160 (if Agent option is installed) 1
HP174 453564060021 WATER TRAP,DSPSBL,ETCO2,3160 (if ETCO2 option is installed) 1
94021 989803152541 KIT,SAMPLE,ETCO2,3160 (if ETCO2 option is installed) 1
N/A 989803162051 ANESTHETIC.OXYGEN SENSOR,DISP. (if Agent option is installed) 1
N/A 989803169491 BATTERY,MRI,14.8V,5.08 AH 2
9065 989803152881 BATT.3.7V,WRLS.PAT.MDLE. 2
HE61 453564060151 ANTENNA,2.4GHZ,RA,MALE 2*
*Quantity may vary if more than one (1) CRD is with the system.
Preventive Maintenance Schedule
Preventive maintenance procedures are those procedures recommended for performance on a periodic
basis in order to minimize equipment failure and prevent unnecessary repairs on the monitor. The
following subparagraphs describe the various periodic maintenance tasks for the monitor, and prescribe
the frequency with which each task should optimally be performed.
Patient Module Battery Charging (Every 8 Hours of Use). Charge the Patient Module battery(ies).
Monitor Verification (Every 6 Months). Perform the Verification Procedure for the monitor.
Monitor Cleaning ‐ External (Every 6 Months).
Battery Tests (Every 12 Months). Perform the Battery Tests (see Page 7‐18, paragraph 7.10).
Consumable Parts (Every 12 Months). Replace the following consumable items with new parts:
a. CART 14.4V Lithium Ion Battery (2 each unit).
b. WECG/WSPO2 Patient Module 4.1V LI Batteries (1 each).
c. Water Trap (Agent Option or ETCO2 Option Only).
d. Disposable Anesthetic Oxygen Sensor (Agent Option Only)
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
169
REF 989803173851 APPENDIX K: SERVICE PARTS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
170
APPENDIX L—SERVICE TAGS & SERIAL LABEL LOCATIONS
Anytime a call is placed to the Call Center (for Field
Service Request, Bench Repair, Parts order,
Troubleshooting), use the SERVICE # and SN only from
the Service Tag Label to create a case number:
Do not use the information off of the Serial Number
Label:
For the CART and the CRD, the Service Tag and Serial
Number Labels are located on the right rear side of the
Display unit.
For the WECG and WSPO2 modules, the Service Tag
with Serial Number is located inside of the battery
compartment.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
171
REF 989803173851 APPENDIX L: SERVICE TAG & SERAIL LABEL LOCATIONS
Service Tag
Part PMS Service Tag
Description
Number Number Number
865323 865323 Precess MRI Patient Monitor (w/ Agents, IBP, Temp)
865323 865323 Precess MRI Patient Monitor (w/ Agents, IBP)
453564214941
865323 865323 Precess MRI Patient Monitor (w/ Agents, Temp)
865323 865323 Precess MRI Patient Monitor (w/ Agents)
865323 865323 Precess MRI Patient Monitor (w/ ETCO2, IBP, Temp)
865323 865323 Precess MRI Patient Monitor (w/ ETCO2, IBP)
865323 865323 Precess MRI Patient Monitor (w/ ETCO2, Temp)
865323 865323 Precess MRI Patient Monitor (w/ ETCO2)
453564214921
865323 865323 Precess MRI Patient Monitor (Basic w/ IBP, Temp)
865323 865323 Precess MRI Patient Monitor (Basic w/ IBP)
865323 865323 Precess MRI Patient Monitor (Basic w/ Temp)
865323 865323 Precess MRI Patient Monitor (Basic)
865485 865485 Precess Control Room Display w/ Printer, Non‐MR, 3160
865485
865485 865485 Precess Control Room Display w/o Printer, Non‐MR, 3160
989803172431 989803172431 MODULE,WIRELESS SPO2 453564228011
989803172441 989803172441 MODULE,WIRELESS ECG 453564228001
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
172
APPENDIX M—REPAIR, WARRANTY, & REGULATORY
Repair
All repairs on products under warranty must be performed by Philips personnel or returned to an
authorized Centralized Service and Repair Center. Unauthorized repairs will void the warranty.
CAUTION: Annual preventative maintenance is recommended unless stated otherwise in the
service manual. For proper equipment maintenance, perform the service procedures at
the recommended intervals as described in this manual.
If a Precess MRI Patient Monitoring System fails to function properly or requires
maintenance, contact Technical Support during normal business hours EST or 24‐hour
emergency technical assistance. Internationally, please contact your Key Market.
Technical Support will ensure that your system is operational again in the shortest
possible period of time.
CAUTION: No repair of Invivo patient monitoring systems. Only replace damaged parts with
components manufactured or sold by Invivo. Contact the Technical Service and Repair
Center for service and technical assistance.
CAUTION: This product, or any of its parts, must not be repaired other than in accordance with
written instructions provided by Invivo (Philips), or altered without prior written
approval of Invivo Corporation.
CAUTION: The user of this product shall have the sole responsibility for any malfunction which
results from improper use, faulty maintenance, improper repair, damage, or alteration
by anyone other than Invivo (Philips), or its authorized service personnel.
CAUTION: A Caution calls attention to a condition or possible situation that could damage or
destroy the product or the user’s work.
Note: Dispose of the system and parts thereof according to local regulations
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
173
REF 989803173851 APPENDIX M: REPAIR, WARRANTY, REGULATORY INFORMATION
Warranty
Invivo warrants this product, other than its consumable parts, to be free from defects in materials and
workmanship for a period of twelve (12) months from the date of original delivery to the buyer or to
buyer's order, provided that same is properly operated under conditions of normal use, and that
periodic maintenance and service is performed. This same warranty is made for a period of ninety (90)
days on consumable parts. This warranty shall become null and void if the Precess MRI Patient
Monitoring System has been repaired by someone other than Invivo (Philips) or if the product has been
subject to misuse, accident, negligence or abuse.
Invivo's sole obligation under this warranty is limited to repairing a Precess MRI Patient Monitoring
System which has been reported to the Technical Service Center during normal business hours and
shipped transportation prepaid. Invivo (Philips) shall not be liable for any damages including but not
limited to incidental damages, consequential damages or special damages.
This warranty is in lieu of any other warranties, guarantees or conditions, including merchantability or
fitness for a particular purpose. The remedies under this warranty are exclusive and Invivo (Philips)
neither assumes nor authorizes anyone to assume for it any other obligation in connection with the sale
or repair of its products.
INVIVO PRODUCTS CONTAIN PROPRIETARY COPY WRITTEN MATERIAL.
ALL RIGHTS ARE RESERVED BY INVIVO CORP.
Regulatory Information
European Union Declaration of Conformity
To obtain a copy of the Declaration of Conformity to the European Union Medical Device Directive
(93/42/EEC) and Radio & Telecommunications Terminal Equipment Directive (1999/5/EC), contact the
Regulatory Affairs Department at Invivo:
407‐275‐3220
‐or‐
1‐800‐331‐3220 (toll‐free)
Internationally, please contact your key market. For a current listing, go to www.invivocorp.com
Authorized Representative
The Authorized Representative for the European Union (as required by the Medical Device Directive,
93/42/EEC) is as follows:
Philips Medical Systems Boblingen
GmbH, Hewlett‐Packard‐Str. 2
71034, Boblingen Germany
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
174
APPENDIX N—LIST OF SYMBOLS
The symbols defined in the list below may be found in this document or located on the shipping
containers, the system, and accessories of the unit.
Symbol Meaning Symbol Meaning Symbol Meaning
Warning Breathing Effort MR Conditional
Detected
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
175
REF 989803173851 APPENDIX N: LIST OF SYMBOLS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
176
REF 989803173851 APPENDIX N: LIST OF SYMBOLS
Symbol Meaning Symbol Meaning Symbol Meaning
Potential Serial Fiber Optic
restrictions for Communications Temperature
equipment Port
including radios
may apply within
one or more
European (EU)
member states.
Do Not Adjust Radio Network Hardwire Link
Without (Wireless
Referring Modules)
To Service
Manual
Network 1 Waste Gas Cardiac (ECG)
Output Gating Output
Network 2 End‐Tidal CO2 / MR Conditional
O2 / Anesthetic
Agents Input
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
177
REF 989803173851 APPENDIX N: LIST OF SYMBOLS
Symbol Meaning Symbol Meaning Symbol Meaning
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
178
APPENDIX O—PRODUCT SPECIFICATIONS
GENERAL
PATIENT SAFETY
Conforms to UL STD 60601‐1. Certified to CAN/CSA STD C22.2 No. 601.1
Defibrillator protection up to 5 KV.
CART POWER REQUIREMENTS
Operating Voltage/Current/Frequency 100‐240 VAC @ 50/60 Hz, 1.4A (RMS)
Range
Power Consumption, Maximum < 100 Watts
CRD POWER REQUIREMENTS
Operating Voltage/Current/Frequency 100‐240 VAC @ 50/60 Hz, 2A (RMS)
Range
Power Consumption, Maximum < 30 Watts
CART/MODULE BATTERY OPERATION
Battery Type CART: Lithium‐Ion and Module: lithium polymer
Battery Voltage CART: 14.4 Vdc and Module: 4.1 Vdc
Operation Time CART: As indicated by battery status display, the maximum
operation time of battery is approximately 8 hours when
ECG and SpO2 parameters are ON, CO2 and agents are OFF,
and NIBP is ON and running at a 5 minute measurement
interval. (Battery operation may be reduced by up to 2
hours under certain conditions such as having the agent
parameter ON, and running short NIBP cycles.)
Module: Approximate operation time of the battery is 8
hours.
Battery Charge Time CART: Time required to recharge a fully discharged battery is
approximately 12 hours with the system turned OFF.
Module: Time required to recharge a fully discharged
battery is approximately 3 hours.
DC Fuse: CART Rear Panel 5A, 32 V ATO Blade ‐ Invivo Part Number FU39
ENVIRONMENT
Operating Temperature 15 to 35° C (59 to 95° F)
Storage Temperature Batteries (REF 989803169491): 0°C to 40°C (32°F to 104°F)
Anesthetic Oxygen (O2) Sensor (REF 989803162051): ‐40°C
to 35°C (‐40°F to 95°F)
CART, CRD, Wireless Modules, and additional accessories:
‐20°C to 60°C (‐4°F to 140°F)
When storing the system in temperatures beyond the ranges
mentioned above, remove the designated component and
store it appropriately.
Relative Humidity 15 to 80%, non‐condensing
Transport Temperature CART, CRD, wireless modules, and additional accessories:
‐20°C to 60°C (‐4°F to 140°F)
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
179
REF 989803173851 APPENDIX O: PRODUCT SPECIFICATIONS
DIMENSIONS
Height CART: 48.5 ± 0.5 inches (123.2 ± 1.3 cm)
CRD: 10.4 inches (26.4 cm)
Width CART: 17.5 ± 0.5 inches (44.5 ± 1.3 cm)
CRD: 15.3 inches (38.9 cm)
Depth CART: 17.5 ± 0.5 inches (44.5 ± 1.3 cm)
CRD: 4.6 inches (11.7 cm)
Weight CART: 75 ± 0.5 pounds (34 ± 0.2 Kg)
CRD: 20 pounds (9.1 Kg)
DISPLAY
Type 800 x 600 pixel color LCD
Screen Size 12 inch (30.5 cm) diagonal
Sweep Speed 25 or 50 mm/S gives 9.2 S or 4.6 S of display respectively.
For respiration, a speed of .33, 1.56, 3.13, 6.25, 12.5 or 25 mm/S
is used.
Waveform Display Mode Fixed Trace, Moving Erase Bar
Waveform Display Height ≥ 19 mm
"Full‐Screen" Display Height ≥ 75 mm
Display Bandwidth 33 Hz
WECG WIRELESS ECG MODULE
Compatibility 1.5 and 3.0 Tesla
Lead Fail Passive, sensing signal imbalance
Pulse Range 30 to 240 bpm (Adult)
30 to 300 bpm (Neonate, Pediatric)
Accuracy Plus or minus 1 percent or ±1 bpm, whichever is greater, in the
absence of a MRI gradient artifact.
Resolution 1 bpm
Input Voltage Range ‐5 mV to +5 mV
Sensitivity Adult > 200 V; Pediatric and Neonate > 100 V
Pacemaker Pulse Rejection The system should be designed to meet requirements of AAMI
EC13‐1983 standard for cardiac monitors (Pacer Reject Mode).
DIMENSIONS
Height 4.7 inches (11.9 cm)
Width 2.5 inches (6.4 cm)
Depth 0.91 inches (2.3 cm)
Weight 5.4 ounces (158.8 gm)
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
180
REF 989803173851 APPENDIX O: PRODUCT SPECIFICATIONS
WSPO2 WIRELESS SPO2 MODULE
Module not to be placed inside of bore. Compatible up to face of bore.
Compatibility 1.5 and 3.0 Tesla
Saturation Range 0 to 100%
Saturation Accuracy Plus or minus 3 percent at 70 – 100 percent (The specified
accuracy is the root‐mean square [RMS] difference between the
measured values and the reference values.)
Pulse Range 30 bpm to 250 bpm
Pulse Accuracy Plus or minus 2 percent or 1 bpm, whichever is greater
RESPIRATION
Respiration Rate 0 to 60 breaths/minute. The alarm limits go up to 150.
Accuracy ±1 breath/minute
Sensor Type Chest bellows; Pressure Transducer
DIMENSIONS
Height 5.5 inches (13.9 cm)
Width 2.5 inches (6.4 cm)
Depth 0.91 inches (2.3 cm)
Weight 5.4 ounces (158.8 gm)
WECG/WSPO2 3.7V Battery Charger (9023)
POWER REQUIREMENTS
Input Voltage (to AC adapter) Universal AC; 85 to 265VAC @ 47 to 63Hz
Input Power 40W without power factor correction
Grounding Connection Hospital Grade (with earth ground)
Protection Over/under voltage, reverse voltage, under current
DC Connector 5 Vdc
ENVIRONMENT
Location Console Room (outside of MRI magnet room)
Operating Temperature 0 to 40° C (32 to 104° F)
CHARGING CHARACTERISTICS
Battery Charge Time 8 hours maximum from fully discharged to fully charged.
Battery Presence Detection Microswitch; charging and LED indication start immediately
upon detection.
Battery Type 3.7V lithium ion, 0.64+ Amp‐Hours.
Battery Charge Control Constant current/constant voltage format, “wake‐up” charge on
fully discharged batteries, battery data communication
verification.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
181
REF 989803173851 APPENDIX O: PRODUCT SPECIFICATIONS
DIMENSIONS
Height 3.23 inches (8.20cm)
Width 7.98 inches (20.27cm)
Depth 5.54 inches (14.07cm)
RECORDER (HT18 Thermal Array Recorder)
Chart Speed 25 or 50 mm/second
Paper Type and Size Non‐Grid Thermal Paper, 50 mm wide
Alphanumeric annotation of date, time delay, paper speed, scales, lead configuration, patient type, heart
rate, SpO2, EtCO2, respiration rate (bellows), respiration rate (CO2), (NIBP (systolic, mean, diastolic), invasive
pressure P1 and P2 (systolic, mean, diastolic), temperature, primary agent Et and Fi, and O2.
Automatic activation on alarm with alarm parameter printed at the beginning of trace.
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
182
REF 989803173851 APPENDIX O: PRODUCT SPECIFICATIONS
WARNING: THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND/OR PROPRIETARY. ANY RELEASE OR DISTRIBUTION
OF THIS MATERIAL, WITHOUT PERMISSION, IS A VIOLATION OF LAW.
183