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UT 4000F Pro

Multi-parameter Patient Monitor

M3.01E

OPERATOR’S MANUAL

Shenzhen Goldway Industrial, Inc.


UT4000F PRO Shenzhen Goldway Industrial, Inc

TABLE OF CONTENTS

SECTION 1 INTRODUCTION ........................................................................................................... 1-1

1.1 GENERAL ..................................................................................................................................... 1-1


1.2 WARRANTY .................................................................................................................................. 1-1
1.3 CUSTOMER SUPPORT .................................................................................................................... 1-1
1.4 IMPORTATNT INFORMATION .......................................................................................................... 1-1

SECTION 2 SAFETY .......................................................................................................................... 2-1

2.1 SAFETY ....................................................................................................................................... 2-1


2.2 SAFETY REQUIREMENTS .............................................................................................................. 2-1
2.3 LABELING ................................................................................................................................... 2-3

SECTION 3 CONTROLS AND CONNECTORS............................................................................... 3-1

3.1 FRONT PANEL ............................................................................................................................... 3-1


3.2 SIDE PANEL .................................................................................................................................. 3-2
3.3 REAR PANEL ................................................................................................................................. 3-3
3.4 POWER SUPPLY ............................................................................................................................. 3-4
3.5 KEYS AND BUTTONS ..................................................................................................................... 3-5
3.6 MENU ..................................................................................................................................... 3-5
3.7 PRINT(OPTIONAL) ................................................................................................................... 3-7
3.8 INSTALLATION AND CONNECTION................................................................................................. 3-8
3.9 DISPLAY SCREEN .......................................................................................................................... 3-8
3.10 ACCESSORIES ........................................................................................................................... 3-10

SECTION 4 ALARM SETUP .............................................................................................................. 4-1

SECTION 5 MONITORING SYSTEM SETUP .................................................................................. 5-1

5.1 ECG WAVEFORM RECALL SETUP .................................................................................................... 5-1


5.2 TREND DISPLAY............................................................................................................................ 5-3
5.3 DEMO MODE................................................................................................................................. 5-4
5.4 DISPLAY SETUP............................................................................................................................. 5-5
5.5 PATIENT SETUP ............................................................................................................................. 5-6
5.6 DATE AND TIME SETUP ................................................................................................................. 5-7
5.7 PRINT SETUP ................................................................................................................................ 5-7
5.8 VOLUME AND BRIGHTNESS SETUP ................................................................................................ 5-9
5.9 DRUG CALCULATION .................................................................................................................... 5-9
5.10 DEFAULT SETTINGS ...................................................................................................................5-11
5.11 HR/PR PRIORITY SETUP ..............................................................................................................5-11
5.12 DISPLAY INTERFACE SELECTION .............................................................................................. 5-12
5.13 CENTRAL STATION COMMUNICATION PORT ............................................................................... 5-12
5.14 ABOUT…. ................................................................................................................................ 5-12
5.15 CHOOSE LANGUAGE…. ............................................................................................................ 5-13
5.16 SYSTEM MAINTENANCE ........................................................................................................... 5-13

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SECTION 6 ECG MONITORING....................................................................................................... 6-1

6.1 MONITORING PREPARATION.......................................................................................................... 6-1


6.2 ECG SETUP ................................................................................................................................... 6-2
6.3 PRECAUTIONS .............................................................................................................................. 6-5
6.4 TROUBLESHOOTING ..................................................................................................................... 6-6

SECTION 7 NIBP MONITORING...................................................................................................... 7-1

7.1 PREPRATION BEFORE NIBP MONITORING ....................................................................................... 7-1


7.2 NIBP SETUP ................................................................................................................................. 7-1
7.3 ALARM MESSAGE ......................................................................................................................... 7-6
7.4 MAINTENANCE ............................................................................................................................. 7-6

SECTION 8 IBP MONITORING (OPTIONAL) ................................................................................. 8-1

8.1 IBP SETUP ..................................................................................................................................... 8-1


8.2 TRANSDUCER CONNECTION ......................................................................................................... 8-4
8.3 TRANSDUCER ZEROING ................................................................................................................ 8-5
8.4 TROUBLESHOOTING ..................................................................................................................... 8-6
8.5 PRECAUTIONS .............................................................................................................................. 8-6

SECTION 9 SPO2 MONITORING ..................................................................................................... 9-1

9.1 GENERAL INFORMATION ............................................................................................................... 9-1


9.2 SPO2 SENSOR ............................................................................................................................... 9-2
9.3 PRECAUTIONS .............................................................................................................................. 9-2
9.4 TROUBLESHOOTING ..................................................................................................................... 9-3

SECTION 10 TEMPERATURE MONITORING .............................................................................. 10-1

SECTION 11 CO2 MONITORING(OPTIONAL)……….…………………………………………………...11-1

SECTION 12 RESPIRATION MONITORING ................................................................................. 12-1

SECTION 13 ARRHYTHMIA ANALYSIS(OPTIONAL) ................................................................ 13-1

SECTION 14 MULTI-GAS MONITORING (OPTIONAL) ............................................................. 14-1

SECTION15 CARDIAC OUTPUT (OPTIONAL) …………………………………………… … …15-1

APPENDIX I PRODUCT SPECIFICATIONS……………………….……………..…………… . .Ⅰ-1

APPENDIX II MAINTENANCE...................................................................................................... .Ⅱ-1

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SECTION 1 INTRODUCTION

1.1 General

Welcome to use UT 4000F Pro portable patient monitor! This manual includes detailed
information on the performance specifications, operation and maintenance. Please read
the manual carefully before using the monitor in order to use the monitor correctly and
ensure monitor’s performance according to the specifications and in conformity with
the safety standards.

1.2 Warranty

The warranty does not apply if the product:


 has been damaged from improper operation (misuse).
 has been damaged because of improper connection to other devices.
 has been damaged by accident.
 has been modified without written authorization of the Company.
 has had the serial number removed or defaced.

1.3 Customer Support

Please contact your local dealer in case product failure happens and provide the
following information:
 Failure phenomenon or the part number of the defective component
 The model number and serial number of the patient monitor

1.4 Important Information

 Please keep the manual to be easily accessible to the operators.


 The product is made under the ISO9001 and EN46001 quality system certified
by TUVPS.

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SECTION 2 SAFETY

2.1 Safety

2.1.1 Intended Use

This patient monitor is used to provide continuous monitoring, display and recording
of ECG, non-invasive blood pressure, pulse oximetry, temperature of patients from
adults to neonates. This device is for use only by trained medical personnel.

2.1.2 The following warnings, cautions, notes are used to alert operators to pay
attention to during operations.

Warning: If not avoided, it may lead to death or serious injury.

Caution: If not avoided, it may lead to minor injury to human body or damage to
product.

Note: Useful information provided to ensure more efficient and convenient operation
of the product.

2.1.3 Safety

The safety requirements in this chapter very general. Specific requirements are stated in
the following sections one by one.

The importance of safety requirements has no relation to the sequence.

2.2 Safety Requirements

 UT 4000F PRO is not intended to be used as an apnea monitor.


WARNING  Do not use it during MRI or CT scan.
 Please do not rely on the alarm functions of the patient monitor. The
alarm limits may be improperly set or alarm may be disabled
 Alarm functions of the patient monitor must be checked regularly.
 Do not use cables with exposed conductor at both ends.Before using the cables,
please check the cable and connectors. If any damage is found, replace it
immediately.
 Electro-surgery circuit must be connected properly to prevent burns or even death.
 When several devices are used on the same patient, leakage current may increase and
lead to danger to the patient. Before using, please consult professional people to do
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leakage current test and make sure the leakage current is within safety limits.
 When defibrillator is used, make sure patient will not get in touch with the ground of
metal or other conductor or device. During defibrillation, never get in touch with
patient, table or the device.
 When electrosurgery unit is used, make sure the patient lead and cable shall be far
away from the operating table to reduce the risk of burns caused by poor connection.
 Do not use the monitor in the environment of flammable anesthesia gases.
 Operator shall not touch the patient and the patient monitor signal input or output
terminal.
 Before changing to another patient, make sure all the previous monitoring data are
cleared to avoid confusion.
 Before using the patient monitor, make sure the device is in normal working
conditions.

 USA and Canadian Federal Law restricts the sale and use of the device to, or
CAUTION on the order of, a licensed practitioner.
 Use properly grounded power sockets and ensure adequate
grounding. If there is any doubts about the grounding, please use
battery operation.
 Check accessories on regular basis and discard damaged accessories properly.
 To ensure patient’s safety and performance of the product, use only the manufacturer
recommended accessories.
 ECG electrodes are disposable and only for single patient use.
 Service parts must be in conformity with IEC 60601 standards.
 Even not being used, the battery may also discharge. So check the battery level every
month.
 ECG cable socket is for connecting ECG leadwires only. Please do not connect it to
other signal source. Pay attention to the color label and marks of ECG leadwires.
 Please clean the patient monitor and accessories according to the instructions.
Always unplug the power cord before cleaning.
 EMC — The device is in conformity with the requirements of IEC 60601-1-2 and
related EMC standards. But when electromagnetic power is extremely high, it may
cause interference. Please ensure the devices close to the patient monitor meet the
related EMC requirements. Do not use cell phone or personal telecommunication
devices.
 Unknown EMI may be caused by radio transmitter or TV. Please remove the patient
monitor or add shielding materials.
 Loss of data — When the device incidentally loses data, please keep patient under
close attention until the device returns to normal.
 Other devices connecting to the device shall meet IEC standards (for example, data
processing device shall meet IEC 950 and medical device shall meet IEC60601-1)
and the whole system shall meet the latest version of IEC60601-1-1 standards.
 Packaging plastic bags and other packaging materials shall be keep away from
children or disposed in accordance with related regulations.

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 After the device or the accessories are at the end of life cycle, please dispose them
according to the local laws and regulations.

2.3 Labeling

Note: Because the configurations are different, perhaps your patient monitor does not
have certain labels .

BF applied part: Type F applied part meet the requirements of IEC60601-1


standards . Shock protection level is higher than Type B applied part

Defibrillation protection Type CF applied part: Type F applied part, in


conformity with IEC 60601-1 standards. Shock protection level higher than BF
applied part

Note: Please check accompanying documents

Fuse

Equipotentiality

Power ON/OFF(Press-Press)

~ AC

Protective Earth

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SECTION 3 CONTROLS AND CONNECTORS

3.1 Front Panel

The front panel of UT 4000F PRO multi-parameter patient monitor is as shown in


Fig. 3-1:

Fig. 3-1 UT4000F PRO Front Panel

(1) Power indicator When the patient monitor is working, the green LED indicator
lights up. When the patient monitor is plugged into AC socket
but not turned on, yellow LED indicator lights up, indicating
battery is being charged.

(2) Display TFT display for displaying waveform, menu, alarm status and
vital signs.

(3) Alarm Indicator Red/Yellow dual-color alarm indicator. Red LED flashes at the
time of emergency alarm (life is endangered). Yellow LED
flashes at the time of warning alarm. Yellow LED continues on
at the time of alerting alarm.

(4) Main Menu : Press the key to enter main menu.

(5) Freeze/Restore : When waveform is swept, press the key to


freeze the waveform. When waveform is frozen, press
the key to unfreeze the waveform sweep.

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(6) Start/ Stop BP : Press the key to start blood pressure


measurement, press it again to stop blood pressure
measurement.

(7) Silence : Press the key to enable /disable the alarm sound.

(8) Start/Stop Printing : Press the key to activate the recorder

to start printing. Press it again to stop printing. If not


operated after being activated , the recorder will print 90
seconds and automatically stop (except for alarm
triggered printing).

(9) System Setup Menu : Press the key system setup menu
will be displayed on the screen. Press it again, the menu
will disappear.

(10) Knob Under menu display, rotate the knob, the required function
will appear at the bottom of the screen. When the arrow
points to a certain function, press the knob, you can select
the function. Then rotate the knob to change the function.
At the end, press the knob again, you can confirm the
selection.

(11) Power Switch When patient monitor is plugged into AC socket, press and
hold the key, you can turn on or off the patient monitor.

3.2 Side Panel

There are eight receptacles on the side panel. See Fig. 3-2.

ECG/RESP: To accept ECG cable

TEMP1/2: To accept temperature probe extension cable

CO2: To accept CO2 Cable (optional)

NIBP: To accept cuff hose

Fig. 3-2 SpO2: To accept SpO2 extension cable

IBP1/2: To accept IBP cable(optional).

Please check precautions of each parameter in the related sections.


Parameters like IBP1/2、CO2 are optional.

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On the right side panel, built-in recorder is installed.

To load thermal paper: Slightly press the panel of the recorder as the arrow points, then
the panel will eject and place paper inside (see recorder panel diagram for the recorder
paper orientation. And pull a section of paper (about 10cm)out and restore the panel.

3.3 Rear Panel

The rear panel of UT 4000F PRO patient monitor is as shown in Fig. 3-3.

Fig. 3-3 UT4000F PRO Rear View

1 Fuse 1 2 110-230VAC, 50/60Hz power supply socket


3 Fuse 2 4 Equipotentiality
5 Fan(for heat dissipation) 6 RS422(Central Station Interface)
7 External display port 8 Handle

The pins of the Central Station Port RS422 is defined as follows:


1 N.C.(no sign connection) 4 TXD+ (B)(signal output+)
2 N.C. (no signal connection) 5 TXD- (A) (Signal output-)
3 N.C. (no signal connection) 6 RXD- (A)(Signal input-)
7 N.C. (no signal connection) 8 RXD+ (B) (Signal input +)

Devices connecting to the patient monitor shall meet IEC standards. Data
processing device shall meet IEC950 and medical devices shall meet IEC60601-1.

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The complete system shall meet the latest valid standards of IEC60601-1-1.

3.4 Power Supply

3.4.1 AC Power

When AC power is used, UT4000F PRO may be turned on at any time. Before plug it
into line power, check the power with the requirements of the device. On the rear panel,
you can see the voltage and frequency requirements.

After confirming all cables are properly connected, press the power switch on the front
panel. The system will start self-test which lasts about 35 seconds. If the power
indicator on the front panel is green, it shows that the device in normal working
conditions and can be used for vital sign monitoring, communication and battery
charging.

When the device is plugged in to AC power and turned off, the power indicator on the
front panel is yellow, showing the monitor is in standby condition and only battery is
charged.

3.4.1.1 Battery Power Supply


.

When AC power is cut off, UT4000F PRO can still work with the internal battery.
Before use, battery must be charged. Whenever the device is plugged into AC power,
battery will automatically be charged. The battery shall be charged at least for 8 hours
before it becomes full. To ensure battery is fully charged, it is recommended to plug the
device in AC power even the device is not used.

Fully charged battery can support the device continuously working for 1.5-2 hours
while NIBP measurement and printing may accelerate the consumption of battery
power. When the battery power is almost used up, the battery mark at the lower right
corner of the screen will flash, alerting user to plug the device in AC power as soon as
possible. When battery power is not enough to support normal working of the device,
the device will be turned off automatically and will not start to work until being turned
on after plugged into AC power.

WARNING: Even when the device is not working, battery power will be
discharged slowly.

 When the device is being stored for a long time, make sure the battery is full.
 Check the battery status at least every month and recharge it.

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3.5 Keys and Buttons

The buttons of the device are divided into two types:


3.5.1. Function keys

Main Menu

Freeze/Restore

Start/Stop BP

Silence

Start/Stop Print

System Setup Menu

3.5.2 Knob Located at the lower right of the front panel, can be used to move left or
right and confirm (press it). It is used to select functions.

3.6 Menu

Menu offers different selections. The Main Menu key is used to activate the main
menu of the device. The contents of the menu change with the channel setup:

In the main menu line, rotate the knob to point a key (see above IBP2), press the knob,
you can enter the sub-menu operations.

After entering sub-menu, rotate the knob to point to a key and press the knob, you can
enter the next menu or select a function directly and press the knob to confirm the
selection. In the end, rotate the knob to BACK and press the knob to confirm to exit.
Then the setting is validated.

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Volume/Brightness menu may also be displayed by directly pressing the hot key as
follows:

Alarm sound volume has 7 selections. Heart rate sound volume has 8 selections.
Display brightness can be adjusted. Under Normal mode, the screen is bright, suitable
for monitoring in day time. Nights mode is added for specific requirements of the users.
When Nights mode is selected, the screen is darker, suitable for monitoring in night
time.

NOTE: If any alarm occur, the Night mode will be end up.
NOTE: System forbidden to enter Nights mode during alarming process.

NOTE:
1.Under system setup menu, press you can
return to the normal monitoring screen.
2. Under sub-menu mode, press , you can
return to the previous menu.
If continuously press the key, you can return to the
original normal monitoring screen directly.

When user has not done any operations for over 30


seconds, the menu display will automatically
disappear and return to full screen.

System setup menu is as shown on the left. Rotate the


knob to select the menu and press it to confirm, you
can enter the next menu or screen. For example:

1. “ECG Review” showing after being selected, ECG waveform review screen is
entered.

2. “ Demo” mode: After selecting a text, the item will be checked“√ ”, indicating
monitoring mode is changed into Demo mode. Press the knob again, the item will be
unchecked and the operation returns to normal monitoring mode.

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3. At the right side of “HR/PR Priority”, there is a mark “►”, indicating after the knob
is pressed, the next menu will be entered.

3.7 Printing (Optional)

3.7.1 Recorder

The device uses a built-in thermal array recorder

3.7.1.1 Manually controlled printing

Press Start/Stop Print , you can print the history data or waveform of monitoring. Press
the key again, you can stop the printing.

3.7.1.2 Alarm triggered printing

When alarm triggered printing is on, the monitor will automatically trigger printing
when alarm occurs and the monitoring waveform starting from 3 (2 or 1, or 0 which is
selectable) seconds before the alarm occurs can be automatically printed out. The
alarm triggered printing time can be set to print the waveforms of 10s, 15s, 20s or 30s
after alarm occurs and also can be stopped by pressing Start/Stop Print.

3.7.1.3 Timed printing

The recorder can be set to print every 15 minutes /30 minutes/1 hour/4 hours/8 hours/12
hours.

3.7.1.4 Printing annotations

The following annotations can be printed: date, time, speed, parameter setting, blood
pressure scale and data. Every time when printing is started, the above information will
be printed.

3.7.1.5 Printer Paper

It is required to use thermal paper of 50mm width. Keep the paper in cool and dry
environment and avoid direct sun light or heat. Use photocopies for long-time storage.

3.7.1.6 Printing setup

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See Item 7 Printing Setup in Section 5 Monitor System Setup.

3.8 Installation and Connection

3.8.1 Place the device in a well-ventilated environment and make sure observation
and operation are easy.
3.8.2 Make sure the environment is in conformity with the specifications (see
Appendix I)
3.8.3 Plug the power cord into AC power socket
3.8.4 Press the power switch to turn on the monitor.
3.8.5 After self-test is finished, monitoring screen will be displayed.

3.9 Display Screen

Under normal monitoring mode, the display screen is as shown in Fig. 3-4.

Fig. 3-4 Monitoring Screen

Display screen features: Data display is clear, up to 6 or 8 channel waveforms and data
(ECG1, ECG2, SpO2, Resp, CO2, IBP1, IBP2 and NIBP data group) and temperature
data are displayed.

Note: On the bottom line of the ECG waveform channel, a point appears every second forming a
time scale for the ease of observation and diagnosis.

3.9.1. Waveform Channel

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Waveform Channel 1 displays ECG1:ECG waveform and the current lead and ECG
amplitude above the waveform.

Waveform Channel 2-8 can be selected to display:

ECG2/ECG3/ECG4/SpO2/IBP1/IBP2/NIBP/Resp/CO2/Expansion Channel

Note: Expansion channel is used only for displaying expanded ECG waveform and not
for other parameters.

NIBP data group includes DATE (measurement date), TIME (measurement time), HR
(heart rate), ST (ST segment), SpO2, , SYS/DIA(MAP), RESP(respiration rate),
TEMP1 and TEMP2. Blood pressure unit is in (m) for mmHg,Or (k)for kPa.
Temperature unit is in C for Celsius or F or Fahrenheit.

The system records 600-group of blood pressure measurement results but in this
channel, only 3 or 4 groups of data can be display each time in this channel. At the right
side of the data, a status bar indicates the current position being observed. Rotate the
knob, you can observe the previous or next pages.

Note: If ECG, SpO2 or IBP channels shows “ no signal received”, please turn off the machine and
turn it on again and the system will return to normal after restart. If such prompt still exists, please
contact your dealer.

3.9.2 Parameter Display

In the parameter area, the real-time data of the following parameters are displayed:: ♥
(HR/PR), ST, SpO2, Respiration Rate, NIBP, IBP1, IBP2, CO2, Temp1, and Temp2.

NIBP parameters displayed in red color are the systolic and diastolic values and the
blue reading above is mean value. When patient is “adult/child/neonate” and
measurement method is “Manual/Auto/Stat” and blood pressure scale are displayed
close to “NIBP”.

At the right side of SpO2 data display area, there is a red bar, directly showing the
signal strength of SpO2.

When an artery pressure is measured, IBP parameter area displays the systolic and
diastolic readings in red color, mean pressure in blue color. When CVP is measured, in
IBP parameter area, mean pressure is displayed in red color and its systolic and
diastolic pressure readings are displayed in blue. The display position can also be
exchanged.

3.9.3 Status Display

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Status box includes battery power indictor, AC/DC power mark and alarm status.
① Alarm Status: The mark is used to indicate the alarm sound switch ON/OFF
(For details, see Section 4 Alarm Setup).

② Battery power: The mark is used to indicate the battery power. The more
segments, the more power remains.

a) When only two segments remain, the mark starts flash and alarm sound
indicates battery power is low.

b) When only one or no segment remains, the mark turns to red and flashes with
audible alarm, alerting that the power is being used up and the monitor will be powered
off within five minutes if not recharged.

c) When AC power plug icon appears in the position of the battery, it indicates that the
monitor is being powered by AC power and the internal battery is being charged.

3.9.4 Waveform Speed

The unit of waveform speed is mm/s. The speed selections for respiration waveform
and CO2 waveform are 6.25, 12.5 and 25mm/s. For other waveforms, the selections are
12.5, 25 or 50mm/s.

3.9.5 Time Display Area

In this area, the time of monitoring is displayed. YY-MM-DD, Hour:Min.: Sec.

3.10 Accessories

Recommendations: It is recommended to use the accessories listed in the following


table, or accessories with CE mark or in conformity with IEC60601-1 standards.
Otherwise the performances of the patient monitor may be degraded and the
patient safety may be endangered.

Description Manufactuer Model/Part No.


Cuff Welch Allyn / V-Lok Adult/Child/Neonate
Temperature Probe YSI YSI 401/ YSI 409B
SpO2 Sensor BCI 3444 Finger Sensor
ECG Cable Changke SMD 780A
Electrodes CONMED REF 1700-030

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Watertrap w/ sampling line Welch Allyn REF 008-0782


(Low Humidity)
Watertrap w/ Adult Nasal Welch Allyn REF 008-0789
sampling line
IBP Cable Medex MX90014/ MX95014
IBP Transducer Medex MX860/ MX9504T
IBP Dome Medex MX848

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SECTION 4 ALARM SETUP

Alarm is to give alert when the monitoring results are abnormal. It is audible and visual
with LED indicators and flashing readings.

Alarm has three degrees: Emergency alarm, warning alarm, alert alarm. Emergency
alarm has 5 beeps, warning alarm 3 beeps and alert alarm 1 beep.

On the front panel of the patient monitor, there are red/yellow alarm LED indicators. At
emergency alarm, red LED flashes, at warning alarm, yellow LED flashes, and at alert
alarm, yellow LED is continuously on.

Emergency Alarm: Asystole, SYS-DIA is too low, Apnea Alarm;


Warning Alarm: Parameters out of alarm limits;
Alert Alarm: Low battery power.

Warning alarm conditions are as follows:

LEAD OFF LOOSE CUFF


PROBE OFF AIR LEAK
CUFF POSITION ERROR OVERPRESSURE
RANGE EXCEEDED OTHER ERROR
NO WATERTRAP FILTER OCCLUSION
CALIBRATION ERROR OCCLUSION
LOW SIGNAL

When sensors or probes are unplugged, the screen will display “Probe off” “ No sensor”
and give alarm.

Note: When “Asystole” is displayed on the sceen, please check for the ECG Gain of
the relative channel to see if it is too low to detect for its heart rate, if so, user can switch
the ECG lead or change the ECG detect source’s channel.

To effectively control the system alarm function, the monitor has alarm ON/OFF and
sound volume selection, which can be set through Alarm Setup .

Rotate the knob in main menu, when arrow points to Alarm Setup , press the knob to
enter alarm setup menu.

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4.1 Alarm On/Off

( 1 ) Press the key on the front panel Silence , you can turn on the system
alarm sound or silence the alarm within a period of time. The alarm has the following 4
statuses:

Alarm sound is on.

Alarm sound is off ( To turn off alarm sound must be done in the alarm setup
menu)

Alarm sound is turned off for 2 minutes. The time is counted down. But new
alarm event may turn the alarm on again.

Alarm sound is turned off for 1 minute. The time is counted down. But new
alarm event may turn the alarm on again.

Note:Press the Silence key on the front panel and at the same time, pay attention to the time display
at the lower part of the status area until the desired time duration of silence is reached. The alarm
switch of different parameters may turned off or on in the parameter setup menus.

During the time of silence, new alarm event may trigger the alarm sound and silence
will become invalid. Within 10 seconds, alarm tone is for the new alarm. Afterwards it
will automatically change according the alarm degrees.

Low battery power alarm is not affected by silence key. It will always alarm whenever
battery power is low.

(2)To turn on or off alarm sound, operate the knob as follows,

 Rotate the Knob Alarm Setup  Press the Knob  Alarm on/off 

Press the Knob On/Off Rotate the Knob Press the Knob

When alarm is off (disabled), you will not hear any sound when new alarm events occur.
Alarm can be enabled through the alarm setup menu or pressing the Silence key on the
front panel.

4. 2 Alarm Limits

Alarm limits including high and low limits. Alarm will be triggered no matter high or

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low limits are exceeded.

The alarm limits are user adjustable.

The alarm setup of parameters are in the parameter setup menus. In the main menu,
rotate the knob to select the parameter and press the knob to confirm. Rotate the knob
again to look for the soft key and press the knob. The original alarm reading turns into
yellow. Now turn the knob left or right, you may increase or decrease the reading until
desired reading is obtained. Then press the knob to confirm.

When NIBP SYS and DIA values are lower than the alarm limits, the device will give
emergency alarm. So in NIBP setup menu, there is Alarm △Bp limit, with range from
0 to 40mmHg. System default is 20 mmHg and will be saved after power off. If the
monitor detects that the SYS and DIA are lower than the limit, the system will give
emergency alarm.

Note: After alarm limits of parameters are set, they will remain in the system after power off until
next setup.

4.3 Alarm Sound Volume

To meet the needs of different users, the main menu offers selection of
Volume & Brightness as follows:

 Rotate the knob Volume & Brightness  Press the knob

Alarm Volume  Press the knob Rotate the knob 1/2/3/4/5/6/7  Press the knob

Or directly press the knob and enter Volume & Brightness menu to adjust the alarm
volume.

4.4 Default Alarm Limits

To return to the factory alarm setting, that is default alarm limits, follow the following
steps to return to the factory alarm limits for adults, children and neonates.

 Rotate the knob Default Setup  Press the knob Rotate the knob

Adult/Child/Neo Default  Press the knob

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The default alarm limits of the patient monitor are as follows,

Parameter Upper limit Lower limit


HR/PR (bpm) 120 40
ST (mV) +0.30 -0.30
SpO2(%) 100 90
NIBP SYS 160 mmHg/21.3kPa 100 mmHg/13.3kPa
NIBP DIA 100 mmHg/13.3kPa 60 mmHg/8.0kPa
Resp(brpm) 4 6
Temp( ℃) 42.0 30.0
IBP SYS 160 mmHg/21.3kPa 100 mmHg/13.3kPa
IBP DIA 100 mmHg/13.3kPa 60 mmHg/8.0kPa
EtCO2(mmHg) 50 8
InCO2(mmHg) 8 0

4.5 Alarm Mode

The device provides two alarm modes, standard and auto, which can be set in the alarm
setup menu.

 Rotate the knob Alarm Setup  Press the knob Rotate the knob

Alarm mode  Press the knob Rotate the knob Standard/Auto  Press the knob

(1)Standard Alarm Mode


When abnormal event happens, and all alarm functions are on, alarm will persist until a
response is received.
(2)Auto Alarm Mode
When abnormal event happens, and all alarm functions are on, alarm will last for 30
seconds and display alert message in a proper position.
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When blood pressure and temperature values are abnormal (out of limits) and all the
alarm functions are on, the alarm sound will last for 30 seconds and automatically turns
off but the readings will continue flashing.
When HR/PR, SpO2 or respiration readings are abnormal (out of limits), and all alarm
functions are on, the device will give real-time sound and flashing reading alarm.
After all alarm setup is completed, rotate the knob to Back , and press the knob to exit

alarm setup.

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SECTION 5 MONITORING SYSTEM SETUP

Patient monitor setup includes: ECG waveform recall, Trend


display, VPC Analysis, Demo mode, Channel setup, Patient
information setting, Date and time setting, Print setup, Volume
and brightness setting, Drug calculation, Default setup, Alarm
setup, HR/PR priority, Select interface, Choose language, and
system maintenance. The system setup menu is as follows,

5.1 ECG Waveform Recall

The past 12-minute ECG waveform can be recalled. When a


patient’s ECG waveform is abnormal, it can be used to review the
waveform. The recalled ECG data are from the channel where
heart rate is detected.

Following the steps below to recall ECG waveform:

 Rotate the knob ECG Recall…  Press the knob

In the above figure, you can see “ECG waveform recall” on the top of the screen. The
status bar at the right side indicates the position and length of the waveform recall. The
five time data at the left side are the start times of every three line of recalled waveform.

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The first line is 24 seconds, including 3 segments, each segment is 6 seconds. The
segment in red at the bottom of the screen is magnified with lead mode and amplitude
marked out. The two time data at the bottom respectively indicate the start and end time
of ECG waveform recall.

The ECG waveform recall speed changes with the current sweep speed.

In the process of ECG waveform recall, rotate the knob, you can scroll up and down the
ECG waveform in memory. Press “Waveform Sweep”, the waveform sweep status is
displayed.

Press “ECG Analysis”, ECG waveform analysis can be done. See figure below:

Press “Measure Position”, a base point can be set on the magnified ECG waveform.

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Then rotate the knob, the cursor will move along the waveform. At the same time, the
screen will be as shown in the figure below. Move the cursor to change the relative time
and amplitude of the point and realize EGC waveform analysis.
Rotate the knob to Exit , and press the knob to return to system setup menu.

5.2 Trend Display

The device provides up to 120-hour monitoring history data, which can be displayed
through trend display function. Follow the steps below to enter trend display:

Rotate the knob Trend Display… Press the knob

In the “Trend Display”, the text at the left side for example “HR/PR” in the above
figure are the high and low alarm limits of the parameters of the trend.

Except for NIBP, TEMP, CO2 and IBP, all other parameters have two horizontal lines
respectively indicating the high and low alarm limits.

In the time status box under the trend graph, the time data at left and right sides indicate
the start and end time of the trend graph. The time in the middle indicate the time where
the cursor is. When the actual monitoring time is not enough to be displayed in the full
screen, the time at the right side indicates the last trend record time and the time at the
left side indicates the start time of monitoring.

The display status bar at the right side of the trend graph shows if all the trend is
displayed on the single page. If yes, the status bar is full. If not, it indicates that the trend

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is not completely displayed and you can press Up/Down to display the trend in the
next page. The functions of the menu items are as follows:

Move scale : To move the scale and observe different time

Up/Down : To move the trend up and down

Left/Right : To display previous or next trend

Zoom : To set the time duration of trend display


(2 hours→4 hours→8 hours→24 hours→48 hours→72 hours→96 hours→120 hours)
Priority Display : To select to display the parameter waveform of the trend.

Note: 1. When press the knob to confirm


Priority Display , the cursor enters the parameter

box at the left side in the above figure. Rotate


the knob to select the parameter to be changed
and press the knob, then the cursor enters into
the options at the right side: SpO2, IBP1, IBP2,
CO2, RR, NIBP, Temp, and you can rotate and
press the knob to select the parameter of the
trend to be observed. When ready, press
Confirm and then the trend graph will display
the trend of the set parameter.

2. In the Temp trend display, Temp1 is displayed in blue, Temp2 in green.

3. In the IBP trend display, blue line indicates SYS, green line indicates DIA, pink line
indicates MEAN. The display range of IBP trend is from -30 to 300mmHg.

In the end, press the Main Menu key on the front panel to exit the trend display and
return to the main menu screen.

5.3 Demo Mode

For the purpose of training, the device provides the Demo mode function.

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Never use this function during patient monitoring!

To enter demo mode:

Main Menu Rotate knob System Setup Press knobRotate knob Demo

Mode Press knob


A dialog box will pop up at this time as follows, you should input the password “8727”
then choose “ok” to enter Demo mode.

When the device is in Demo mode, you will see “DEMO MODE” on the screen.
To return to normal monitoring mode:

Main Menu Rotate knob System Setup Press knobRotate knob Demo

Mode Press knob

5.4 Display Setup

The display setup menu can be entered from the system main menu, mainly for setting
the bed mode, channel mode and the parameters of the channels.

Waveform Channel 1 displays ECG1: ECG waveform and indicates the current led and
ECG amplitude above the waveform.

Waveform Channel 2-8 can be selected to display:


ECG2/ECG3/ECG4/SpO2/Resp/IBP1/IBP2/CO2/NIBP/Expansion channel.
Temperature parameter is displayed at the bottom in the parameter area.

Note: Expansion channel is only used for display ECG waveform, not any other parameter
waveform.

In the process of setup, when a parameter setup of a channel is the same with that of
another channel, then the original parameter will be displayed in exchange. The
parameter displayed in the main menu changes with the display channel setup.

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 Rotate Knob Display Channel Setup Press Knob Channel Mode Press
knob

Through the above operations, the screen display is as follows. Channel mode can be
set to 6 or 8- channel mode.

When display setup is completed, rotate the knob to Confirm , and press the knob to
exit display setup.

5.5 Patient Setup

In the monitoring process, patient information can be entered for the ease of
observation but it will not remain after power off. To enter the patient setup dialog box:

Rotate the knob Patient Setup  Press the Knob

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In the above dialog box, when a setup box is selected, the screen will immediately pop
up the above box. Patient name, ID number, bed number can be entered through
rotating and pressing the knob. Then select sex, mode and whether new patient or old
patient (whether to clear original data).

5.6 Date and Time Setup

The device displays the real date and time. Each time the device is turned on, it will
display the current date and time.

To enter time setup:

Rotate knob Date/Time Setup Press knob

Rotate the knob and press the knob, you can change the date and time. When date and
time are set, please rotate to Confirm and press the knob to exit the setup. Then the
device will display the updated date and time otherwise it will be regarded as change is
canceled. If a change is completed and you want to cancel it, then rotate the knob to
Cancel , press the knob and exit. Then the screen will still display the original date and
time.

5.7 Printing Setup

Printer setup is used to select printing contents, printing speed, printing channels and
setup alarm triggered printing, prepositioned time, printing duration and printing
interval.

The device can be used to print the history data or dual-channel monitoring waveform.
To select printing contents:

Rotate the knob Printing Setup Press the knobRotate the knob Printing

Contents  Press the knob Data/Waveform Rotate the knob Press the knob

When data printing is selected, the monitor will print the previous 20 records of the
current NIBP data window.

The printing speed options include: Auto/12.5/25.0/50.0 mm/S. If Auto is selected, then
the printing speed is the same with the ECG waveform speed. To select printing speed:

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Rotate the knob Printing Setup Press the knobRotate the knob Printing

Speed Press the knob Auto/12.5/25.0/50.0 mm/S Rotate the knobPress the
knob

Printing channel 1 can be selected to print ECG1, ECG2, ECG3 or ECG4 waveform.
Printing channel 2 can be selected to print RESP, CO2, IBP1, IBP2 or SpO2 waveform.
But the two channels cannot be selected to print the same waveform. Follow the steps
below,
Rotate the knob Printing Setup Press the knobRotate the

knob Waveform Channel 1 Press the knobRotate the knobPress the knob

Auto /Default printing mode can also be selected as follows,

 Rotate the knob Printing Setup Press the knobRotate the

knob Printing Mode Press the knobRotate the knobPress the knob

When out-of-limit alarm occurs, the device can automatically activate the printer to
print the waveform out. Alarm triggered printing ON/OFF setup procedures are as
follows,
Rotate the knob Printing Setup Press the knobRotate the knob

Alarm Trigger Press the knob

When alarm triggered printing is set to ON , the alarm triggered printing time can be set
to printing 10s, 15s, 20s or 30s after alarm (the record start time is 3/2/0 second before
alarm). Follow the steps below:

Rotate the knob Printing Setup Press the knobRotate the knob Alarm

printing duration Press the knobRotate the knob 10S/15S/20S/30S Press the
knob
When press Print to start printing or alarm triggered printing, the system will print
starting from a few second before start. The time can be set as follows:

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Rotate the knob Printing Setup Press the knobRotate the knob

Prepositioned Time Press the knob Rotate the knob 3/2/1/0 sec  Press the
knob

Note: 1. Alarm triggered printing is only used to print waveform.


2. ECG waveform printed under auto gain mode is not calibration significant.

After printing setup is completed, rotate the knob to Exit , and press the knob to
confirm and exit the printing setup.

5.8 Volume and Brightness Setup

Volume & Brightness Setup menu can also be displayed when the knob is pressed at
the following hot keys:

Alarm sound volume has 1-7 total 7 levels. Heart rate sound volume has 0-7 total 8
levels for users to make adjustments according to the actual needs. Brightness
adjustment is used to adjust the screen brightness. When “Standard” is selected, the
screen is bright, suitable for monitoring in day time. When “Soft” is selected, the screen
is slightly dark, suitable for monitoring during night time.

5.9 Drug calculation

Monitor can calculate and output titration chart according to the drug consistence input
by medical personnel, and display the injecting speed and time.
Select Drug calculation in the system setup menu,

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1. Patient name: should be input with letters;


2. Patient No.: should be input with letters and
numbers;
3. Patient Type selection: Adult/ Child/ Neonate;
4. Drug name selection: Dopamine/dobutamine/
epinephrine/aminophylline/nipride/nitroglycerin/
heparin/diazepam/penicillin/pitocin/heparin/insulin
/lidocaline/fentany1/procainamide/cephalothin-cef
obid/drug A/drug B/drug C/ drug D/drug E.
5. Body weight: the unit should be kg.
6. Total dose: unit selection include g, mg, mcg, mEq,
unit, k unit, m unit.
7. SOL volume:Diluted solution volume.
8. Drug concent: Diluted solution consistence, unit is
mg/ml. Consistence= Total Dose/ SOL volume.
9. Dosage Unit:/kg/min, /kg /hr.
10. Dosage:Drug input in time unit.
11. Perfu Rate: Transfusion speed, unit is ml/hr.
12. Titra. Rate: Titration speed, unit is GTT/min.
13. Drop Volume : Volume per drop, 15 or 20 GTT/ml can be select.
14. Medica. time:Dose time, unit is hour, Dose time=Total dose / Dosage.
Note:
①Patient name and patient number are not necessary to fill in, they can be kept blank.
②Patient type, drug name and body weight must be filled in before inputting other
information.
③If patient is neonate, then Transfusion speed and Drop Volume is useless.
④After inputting Patient type, drug name, body weight and dosage, system will pop-up
a dialog box for confirming the data, in order to avoid inputting error.
⑤Doctor can define Drug A/B/C/D/E, but should pay attention to the settled unit of each
drug’s total dose.
Drug A/B unit is g、mg、mcg;
Drug C/D unit is unit、k unit、m unit;
Drug E unit is mEq.

Click “Titration chart” in above figure after inputting above information, the titration chart will be
showed as follow,

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List different transfusion speed corresponding different dosage in above chart, to


convenient for medical personnel.

Step:to select display step, range is 1、2、3 ~ 10;


Scroll:press this key to look over next page’s titration chart.
Print:press this key to print current page’s titration chart.

5.10 Default Settings

The device has different default settings for different patients, i.e. adults, children and
neonates. To return to the default settings of the factory, follow the following steps:

Rotate the knob Default Setting Press the knob

Adult/Pediatric/Neonate Default  Rotate the knob  Press the knob

Alarm setting defaults are not controlled by system default settings. After default setting, wait for
over 5 seconds before turning the monitor off.

Note: When monitor is incidentally powered off during monitoring (due to power failure or
disconnection of power plug), please turn of the machine immediately and do not turn on the
machine until power returns to normal. History data (trend graph and waveform recall) are lost when
power off.

5.11 HR/PR Priority Setup

 Rotate the knob HR/PR Priority  Press the knob 1st Priority/2nd Priority
Rotate the knobPress the knob

Where, 1st priority includes ECG/SpO2/IBP and 2nd priority includes SpO2/ECG/IBP.

When 1st priority is selected, heart rate (HR) is first displayed in the parameter area in
priority. When ECG is not detected, the parameter area displays SpO2 pulse rate(PR)
or IBP pulse rate(PR). When no heart rate or pulse rate is detected, the parameter area
displays“——”.

When 2nd priority is selected, the parameter area first displays SpO2 pulse rate (PR).
When SpO2 sensor is not connected, the parameter area will display heart rate (HR) or
IBP pulse rate (PR). When no heart rate or pulse rate is detected, the parameter area will
display“——”.

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5.12 Display Interface Selection

 Rotate the knob Select interface Press the knob Rotate the knob

 Enhanced waveform/ Big Font Press the knob

Display interface can be selected Enhanced Waveform/Big font (shown as above), this
two kind of interface convenient for medical personnel to observe from long distance.
User also can select both or neither of them.

The other method to setup “Big Font” interface: Press the knob, the menu as follow
shown will pop-up in the screen, rotate the knob and select “Big Font”.

5.13 Central Station Communication Port

The monitor communicate with the central station through Serial Port.

5.14 About…

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Enter “About…” from the system setup menu, the screen will display the product’s
model, software version and manufacturer’s name.

5.15 Choose Language

If Language is setup to be English in the System Maintenance menu, then here can only
select English. System display interface will be English version.

If Language is setup to be Polish in the System Maintenance menu, then here can
select Polish or English. System display interface can be switched between English
version and Polish version.

5.16 System Maintenance

Rotate the knob System Maintenance…  Press the knob

Then, the screen will display the following:

To prevent other people misuse the machine, we set a password for the system. User
should enter the correct password and press confirm before you can enter the following
system maintenance menu:

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User can do Factory Setup, Pressure Compensation, VPC ON/OFF, Bed Mode ON/OFF,
Central Station Communication port Selection and Language Chosen in this menu.

Note : System maintenance menu is not suggested to be used by operator, it is


convenient for service engineer and for monitor’s setup before leaving factory.

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SECTION 6 ECG MONITORING

Continuous ECG waveform and heart rate are monitored for accurate evaluation on
patient’s physical status. To obtain correct measurement values, sufficient preparations
must be made.

6.1 Preparations

6.1.1 Skin Preparation

ECG signal quality relies on the signal from ECG electrodes. To obtain good signal,
skin must be cleaned before applying electrodes. It is recommended to:
(1)Shave the hair on the position where electrode will be applied.
(2)Gently rub the skin to remove the cutin.
(3)Clean the skin with alcohol or soap water.
(4)Apply electrodes when skin is completely dry.

6.1.2 Monitoring Preparation

(1)Apply electrodes to the skin which has been cleaned. The correct positions of
electrode application are as follows: RA, LA, RL, LL, and V:

(2)Connect the ECG leads to the electrodes, then connect the leads to the ECG cable.
Ensure the leads are in the correct position. The ECG leads and patient cable
connector are color-coded according to the AAMI standard for ECG leads. Refer
to the ECG 5-lead Electrode Identification table as follows,

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Table: ECG 5-lead Electrode Identification

ELECTRODE LABEL LOCATION COLOR


RA Right Arm White
RL Right Leg Green
LA Left Arm Black
LL Left Leg Red
V 4th Intercostal Space Brown

(3)Plug the ECG cable into the socket at the side panel of the monitor.

On the ECG socket mark indicates signal input part is highly insulated and
defibrillation protected and patient safety can be ensured. In the same time, in the
defibrillation and electrosurgical procedures, monitor will not be damaged.

(4)Make sure the labels of the 5 leads are correct.


(5)When necessary, ECG setting shall be adjusted. For the setting methods, see 6.2
ECG Setup.
(6)To set the ECG alarm limits, please see Section 4 Alarm Setup.

6.2 ECG Setup

Press ECG1 , the screen displays ECG setup menu A as follows. If press ECG2 , the
screen will pop up setup menu B as follows. Rotate the knob, you can select the
functions displayed below and press the knob to confirm before doing another setup.

ECG Setup Menu A ECG Setup Menu B

Lead Mode : The lead mode include Three Lead / Five Lead.

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ECG Lead : If lead mode select Three Lead, the lead selections available areⅠ/Ⅱ/
Ⅲ ;If lead mode select Five Lead, the lead selections available are Ⅰ / Ⅱ / Ⅲ
/V/aVR/aVL/aVF/GND.

The electrodes are applied mainly to three positions: Right arm (RA), left arm (LA), left
leg (LA), and left leg (LL).

Lead Ⅰ Ⅱ Ⅲ aVR aVL aVF

Positive LA LL LL RA LA LL

Negative RA RA LA LA+LL RA+LL RA+LL

Table 1 Routine Lead ECG Electrode Position

V is chest lead, with V1, V2, V3, V4, V5, V6 lead.


ECG Gain : Options include X1/4, X1/2, X1, X2, X4, Auto.

In order to observe easily, system add staff guage which display on the left of ECG1
channel as show above,
When ECG Gain is set to X1/4,the guage’s length is 2.5mm;
When ECG Gain is set to X1/2,the guage’s length is 5mm;
When ECG Gain is set to X1,the guage’s length is 10 mm;
When ECG Gain is set to X2,the guage’s length is 20mm;
When ECG Gain is set to X4,the guage disappear;
When ECG Gain is set to Auto,the guage’s length will change with ECG gain.
Waveform Speed : 12.5/25.0/50.0 mm/S are available for selection.

1mV Cal : When it is selected, a 1mV calibration square wave will be added on the
ECG waveform in the ECG monitoring process.
Pacemaker Detection : OFF/ ON I / ON II / ON III / ON V are available for selection.
When pacemaker and monitor are both used on the same patient, you may turn on the
pacemaker detection function of the monitor, then the system will detect and smooth
the pacemaker waveform on the ECG waveform in the channel corresponding to the
lead to prevent the pacemaker waveform from being taken as R wave. If “OFF” is
selected, the pacemaker waveform will be displayed on the ECG waveform of the
respective leads.

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ECG Mode : Monitor/Operation/Diagnosis are available for selection straining


waveform mode. If Diagnosis mode is selected, the monitor displays unstrained ECG
waveform. If Monitor mode is selected, the monitor displays ECG waveform whose
false error of fake alarm have been strained;Operation mode is supposed to select
during an operation for the mode can decrease false error and interfere from
Electro-surgery equipment. The ECG mode selected displays on the ECG1 channel.
R-wave Source : If lead mode select Five Lead, ECG1/ECG2/ECG3/ECG4 are
available for selections. If lead mode select Three Lead, only ECG1 channel can detect
HR signal, ECG2/ECG3/ECG4 is closed.
HR Alarm : Turn on/off HR alarm function.

HR upper limit : To setup HR upper limit value.

HR lower limit : To setup HR lower limit value.

ST Segment Setup… : When it is selected, the screen will display the picture as
follows:

P-R measurement position and ST segment measurement position can be changed


when you rotate the knob or press the default setting directly to obtain the system
defaults.
Main Menu Rotate the knob ECG1  Press the knob

ST Segment Setup… Press the knob Rotate the knob ST segment

measurement position  Press the knob Rotate the knob Press the knob

ST upper limit : To setup ST upper limit value.

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ST lower limit : To setup ST lower limit value.

VPC ON/OFF : Turn on/off Arrhythmia analysis function.

VPC learning start :when VPC analysis function is out of the way, select“VPC
learning start”, then system will start learning, rebuild the patient’s ECG template, in
order to analyse VPC correctly.
VPC Alarm :Turn on/off VPC alarm function.

VPC upper limit :To setup VPC upper limit value.

VPC lower limit : To setup VPC lower limit value.

After all ECG settings are completed, rotate the knob to Exit , press the knob to confirm
and exit the ECG setup menu.

6.3 Precautions

6.3.1 How to select and use ECG electrodes correctly?

Besides recommended Ag-Agcl electrodes , we recommend to change the electrode at


least every 48 hours no matter the patient is adults or neonates to ensure good signal
quality. Please discard used electrodes properly.

6.3.2 How to reduce the electrostatic interference and electrosurgical burns?

To clean the skin thoroughly is very important. See 6.1.1 Skin Preparation.

6.3.3 What negative effects may occur if the monitor is used with pacemaker?

When monitor is used with pacemaker, the pulse of pacemaker may be taken as QRS
wave and some pacemaker may result in inaccurate respiration impedance.

6.3.4 How to select ECG cable?

ECG cable socket is only intended for connecting the accompanying ECG cable, no
other conductor or earth shall be connected to it. Check the ECG cable regularly.
Replace it immediately when any damage is found .

6.3.5 How to reduce leakage current when several machines are used at the same
time?

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When several devices are being used on the same patient at the same time, leakage
current may accumulate. Before connecting the devices, leakage current test shall be
done by qualified personnel. If there is any doubt, please consult the manufacturer.

6.3.6 Warning:

①When defibrillator is used, make sure electrode and patient cable are not in contact
with metal or other conductor or grounding part. Please do not touch patient, table or
device during defibrillation.
② Electrosurgical unit shall be properly grounded to prevent current from flowing into
the electrodes. The current may interfere with ECG signal.
③ Electrosurgical unit shall be kept away from patient leadaires and ECG cable.
④ Do not interpret the pacemaker pulse size and shape from diagnosis point of view.
⑤ Make sure ECG cable and electrodes are not in contact with other devices or
conductor, including grounding assembly.
⑥ Do not use the monitor during MRI or CT scan.

6.3.7 Precautions:

① Use only the recommended electrodes, cable and leadwires.


② Leadwires and cable shall be far away from the patient’s throat.
③ Interconnection between many parts of the device may lead to increase of leakage
current.

6.4 Troubleshooting

6.4.1 Inaccurate heart rate or false arrhythmia

(1) Check patient’s ECG signal


Check /adjust the placement of leadwires
Check /clean skin
Check /replace electrodes

(2) Check if the ECG waveform amplitude is normal

6.4. 2 No ECG waveform

After leadwires are connected, the screen displays “Lead off” or “ no signal received”.

(1) Check the electrodes and leadwires to see if connection is proper or there is any
damage.
(2) Check all the leadwire and cable connections.
(3) If the ECG waveform channel displays” No signal received”, it indicates that the

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ECG board has communication problem with the system. Please contact your dealer.

6.4.3 ECG baseline shift

ECG sweep baseline cannot be displayed firmly on the screen and shifts out of the
display area:

(1)Check if the operation environment is humid. If the device has moisture inside,
please turn on the machine for 24 hours.
(2)Check the electrode quality and the skin where electrodes are placed to see if it is
clean enough.

6.4.4 Respiration signal weak

Respiration waveform is very weak on the screen and not easy to see.

Check the positions of the electrodes and the electrode quality and if the skin is clean
enough.

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SECTION 7 NIBP MONITORING

On the NIBP socket mark indicates the signal input part is insulated and
defibrillation protected and patient safety can be ensured. In defibrillation and
electrosurgical procedures, the device will not be damaged.

7.1 Preparations before NIBP Monitoring

1、Use cuffs of proper sizes


2、Ensure the cuff has been completed deflated
3、Place the cuff 2-5cm above the elbow and the hose along the left or right side
4、Screw the cuff hose to the NIBP connector of the patient monitor
5、Make sure there is no block between the monitor and the hose
6、Set blood pressure measurement correctly in the blood pressure setup menu
7、The patient’s arm shall be at the same level as the heart
8、Press the blood pressure start key and start measuring blood pressure

Note:
1. Make sure there is no other pressure on the cuff
2. Wrong sizes of cuffs may result in inaccurate measurements
3. When measuring infants or neonates, make sure the menu setting is correct to
prevent too much pressure from injuring patients.
4. To ensure the patient’s safety, never use cuff on the same arm where infusion is
going on.
5. Do not measure SpO 2 or other parameters on the same arm where blood pressure
is measured.
6. The measurement results of patients suffering from epilepsy disease or trembling
patients may not be accurate.
7. Do not apply cuff on injured part of the body
8. Do not measure a patient’s blood pressure continuously or repetitively for a long
time.
9. Arrhythmia may increase the NIBP measurement time.
10. Accessories recommended by the manufacturer shall be used.
11. Remove the cuff after power off.

7.2 NIBP Setup

The monitor measures patient’s systolic and diastolic blood pressures and calculate the
mean pressure.
When NIBP reading is abnormal and NIBP alarm function is on, the monitor will give
audio and visual alarm. In NIBP setup menu, high and low alarm limits can be set.
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When the difference between the systolic and diastolic pressures of NIBP is lower than
a certain value, the patient status is critical and the monitor gives emergency alarm.
Therefore, in alarm setup menu, there is Alarm BP Difference limits ranging from
0-40mmHg,system default is 20 mmHg and it is saved in the memory after power off.
If the difference between the systolic pressure and the diastolic pressure is lower than a
certain value, the system will give emergency alarm.

NIBP setup includes: Change NIBP work mode (Auto/Manual/Stat), change the auto
interval time of auto mode, select adult/child/neonate, change blood pressure units, set
NIBP alarm limits and turn On or Off the NIBP alarm.

Main Menu Rotate the Knob NIBP Press the knob

User may select the following functions by rotating the knob


and press the knob to confirm and then perform the setup in the
NIBP setup menu as shown in follow. The setting operations are
also through rotating and pressing the knob.

7.2.1 NIBP Work Mode Setup

NIBP Work Mode:

--Manual (MANU)
--Auto (AUTO)
--Stat (STAT)

Note: The current work mode is displayed on the upper right of the NIBP data.
Under NIBP manual mode (MANU), press Start/Stop BP Measurement , then you can
start NIBP measurement. When NIBP measurement is started, the monitor first inflates
the cuff to a certain pressure and then slowly discharge the air in the cuff and measure
the NIBP value of the patient.

Under AUTO mode, the monitor will automatically inflates the cuff at every auto cycle
and measure the NIBP value of the patient automatically. Under auto mode, if patient’s
blood pressure is very high, the monitor may automatically add air to adjust the
maximum inflation pressure.

STAT mode refers to within 5 minutes, a patient’s blood pressure is continuously


measured. It is mainly used in special cases.

When NIBP is measured through manual or button to start NIBP measurement, the
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initial values of cuff inflation pressure is 175mmHg for adults, and 95mmHg for
neonates. The first inflation pressure values are the same for Auto and Stat modes and
start the initial inflation and make adjustment based on the previous measurements.

Change NIBP measurement modes as follows:

Main Menu  Rotate the Knob NIBP  Press the Knob Measure Mode

Press the Knob Rotate the Knob Auto/Manual/Stat  Press the Knob

7.2.2 NIBP Measurement Time Setup

The current mode is displayed at the upper right of the NIBP value and the
corresponding measurement time is displayed behind the mode.

Following STAT, it is always the continuous measurement time:5 minutes


Following AUTO, it is the auto measurement interval. Adjustable ranges are
110´, 15´, 30´, 60´, 90´, 120´, 180´, 240´, 480´ (´ represents minute,which is the time
between the last NIBP measurement start to the next NIBP measurement start and can
be adjusted through knob rotation. Follow the steps below:

Main Menu Rotate the knob NIBP Press the knobRotate the

knob Measurement Time Press the knobRotate the knobPress the knob

Note: Under Stat/Auto mode, the status box prompts the time after “Stat/Auto” which is underlined
(e.g. Auto 01´), when NIBP measurement is started, the underline will automatically disappear and
start to count down the time. When NIBP measurement is paused,, the time display returns to the
original set value , waiting for the next start.

7.2.3 NIBP Measurement Patient Selection

WARNING:When measuring children or neonates, make sure the proper size and position of
the cuff are applied and select the patient in NIBP Setup Menu before you can start the
measurement in order to avoid hazards resulted from over inflation.

Patient selection: Adult, Pediatric, Neonate

Main Menu Rotate the knob NIBP Press the knob Patient Press the

knobRotate the knob Adult/Pediatric/Neonate  Press the knob

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WARNING: On the screen the patient will be prompted close to the NIBP parameter value.
When neonate blood pressure is measured, make sure the NIBP measurement patient is set to
“Neonate”.

7.2.4 NIBP Measurement Scale

The NIBP parameter has two units, i.e. mmHg and kPa, which can be set by the user to
give emphasis to the blood pressure reading.

The change of blood pressure units will be seen with all blood pressure readings, e.g.
parameter area or trend graph. The unit of IBP and NIBP is always the same.

To change the blood pressure unit:


Main Menu Rotate the knob NIBP Press the knobRotate the knob  Scale

Setup Press the knob mmHg/kPa Rotate the knobPress the knob

7.2.5 Pressure Test

Calibration should be taken by qualified professional personnel once a year. The


method for calibrating is introduced in technical manual. Qualified professional
personnel may refer to the technical manual. Enter Pressure test menu:

Main Menu Rotate the knob NIBP Press the knobRotate the knob 

Pressure test Press the knob -6 ~ 6mmHg Rotate the knobPress the knob

Note:Don’t enter Pressure test during NIBP measure period,if not, it will influence
the veracity of NIBP’s measure data.

7.2.6 Dynamic Blood Pressure Monitoring

The monitor can analyze and stat.the NIBP Data,and display stat. results. Dynamic
Blood Pressure monitoring can setup measurement interval (5/10/15/30 minutes
selectable), ON/OFF Monitor function and setup normal pressure upper/lower limits,
ans recall the stat. results.
Main Menu Rotate the knob NIBP Press the knobRotate the knob

Dynamic Blood Pressure Press the knobRotate the knob  measurement interval

Press the knob  5/10/15/30 minutes Rotate the knob  Press the knob
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Note : Operator should setup measurement interval firstly, then activate monitor
function,or the interval can’t be set after monitor function has been activated.

Note:During dynamic blood pressure monitor period, if change measurement patient


setup , the monitor will stop dynamic monitoring automatically. You should activate the
dynamic monitor function again if needed.

Recall stat. result is as follows,

7.3 Alarm

7.3.1 NIBP alarm ON/OFF and alarm limits setup

Operator can activate alarm function and setup alarm limits one by one.
Main Menu Rotate the knob NIBP Press the knobRotate the knob

SYS-DIA alarm Press the knobRotate the knobPress the knob

7.3.2 Alarm Resolvent

Alarm will happen when the following abnormal events occur and messages will be
displayed in the NIBP parameter area: “Cuff loose”, “Cuff not connected”, “Cuff
position error”, “Overpressure protection”, “Measurement out of limits” or
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“Measurement error”. Take the following steps after seeing the messages:

1. Cuff is too loose, not connected or applied to a wrong position

If the NIBP parameter area displays “Cuff loose” or “Cuff not connected” or “Cuff
position is error”, please check the position of the cuff first, and if the cuff tube is
broken.

2. Overpressure Protection

If the NIBP parameter area displays“Overpressure protection”, which indicates that the
problem in the internal inflation circuit results in NIBP measurement failure. Please
contact qualified service personnel for service.

3. Measurement Pressure out of Limit

If the NIBP parameter area displays“Measurement Pressure out of limit”, it is because


the patient’s blood pressure is extremely high and out of the measurement range of the
patient monitor. Wait until the patient is calm down and perform the measurement
again.

4. Measurement Error

If the NIBP parameter area displays“Measurement Error”, it may be the results of


system self-test error, patient being over excited, trembling or air leakage. Please
contact qualified service personnel.

7.4 Maintenance

1. Cuff Cleaning

The cuff can be washed in mild soap water.

2. System Calibration

Every 12 months or when you have doubt about the NIBP readings, please ask qualified
personnel to perform pressure test and parameter calibration and check the cuff and
hose for air leakage.

Note: Never enter the pressure testing menu when measuring NIBP normally, or the
NIBP data will not be precise.

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SECTION 8 IBP MONITORING (Optional)

8.1 IBP Setup

The device displays the maximum systolic pressure, minimum diastolic pressure and
mean pressure and IBP waveform. IBP waveform can be observed in different channels
and the waveform speed is the same with that of ECG waveform. In IBP waveform
channel, there is a scale on the top and at the bottom, which are the scale lines. At the
right end of the line, the IBP reading of this horizontal position is displayed.

Before IBP monitoring, make the following preparations:


— Set IBP channel and labels
— Select IBP waveform display scale
— Set alarm limits
— Set recorder (optional)
— Connect transducer
— Zero the transducer

IBP Setup function is mainly used to set IBP gain, IBP label and IBP zeroing. IBPs
Setup menu is as follows:

IBP Setup Menu Label Setup Zeroing Mode

8.1. 1 IBP Gain


Different IBP gain corresponds to different waveform display scale. The device
provides auto selection of optimal waveform gain (Auto) and manual waveform gain

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(Manual). In IBP waveform channel, there is a scale line on the up and bottom. At the
right end of each line, there is an IBP value corresponding to the level. The difference
between the two IBP values is the selected gain value (40/60/80/330).

Note: Each time when the machine is turned on, IBP is set to be manual zeroing and gain is set to be
330. The setting can be changed but will not be saved after power off.

To set the gain:

Main Menu Rotate the knob IBP1/2 Press the knobRotate the knob

IBP Gain  Press the knobe Auto/40/60/80/330 Rotate the knobPress the knob

8.1. 2 Zeroing Mode

Zeroing has auto and manual modes.

Main Menu Rotate the knob IBP1/2 Press the knobRotate the knob 

Zeroing Mode Press the knob Auto/Manual Rotate the knobPress the knob

① Manual Zeroing

If zeroing mode is set to be “Manual”, then the system will automatically enter IBP
Setup Menu and IBP Zeroing “Yes” status. Now press the knob, the system will start
zeroing.

② Auto Zeroing

When the screen prompt “Press Zeroing Key”, if zeroing mode is set to be Auto, then
the system will automatically give command and start zeroing and the user does not
need to confirm.

③ Enforced Zeroing

When transducer needs to be calibrated, please enter IBP Setup Menu and set IBP1/2
Zeroing status to be “YES”. Such manual zeroing mode is also called “Enforced
Zeroing”. Follow the steps below:
Main Menu Rotate the knob IBP1/2 Press the knob IBP Zeroing Press the
knob

8.1.3 IBP Labeling

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IBP Labels : IP/ART/AO/RA/FA/PA/CVP

IP:Invasive blood pressure, default label


CVP: Central Vein Pressure
ART:Artery Pressure, i.e. the arterial blood pressure being monitored
AO:Aorta Pressure
RA:Radial Artery Pressure
FA: Femoral Artery Pressure
PA:Pulmonary Artery Pressure
When a waveform channel is set to display IBP in the Display Channel Setup (Max.

2 channels for IBP), you may select the labels in IBP Label Setup, so as to indentify the
measurement objects. The IBP labeling methods are as follows:

Main Menu Rotate the konb IBP1/2 Press the knobRotate the knob

IBP Labeling  Press the knob IP/ART/AO/RA/FA/PA/CVP Rotate the knob


Press the knob

Note: When an artery pressure is selected to be measured, the IBP parameter area mainly displays
the SYS and DIA. Mean is displayed in small letters. When CVP is measured, IBP parameter area
mainly displays the mean pressure and the values of its SYS and DIA are displayed in small letters.

8.1. 4 IBP Scale

The device provides two units for displaying IBP measurements, that is mmHg or kPa,
default is mmHg. The unit can be set in Scale Setup .

Main Menu  Rotate the knob IBP1/2 Press the knobRotate the knob

Scale Setup Press the knob mmHg/kPa  Rotate the knob Press the knob

The change in IBP units will be displayed in all the IBP readings, e.g. parameter area
and trend graph.

8.1. 5 Alarm Setup and Printing Setup

After the above setup is completed, the alarm limits for the SYS and DIA of IBP1/2
need to be set.

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Main Menu  Rotate the knob IBP1/2  Press the knob Rotate the knob

SYS High  Press the knob Rotate the knob(Adjust the value) Press the knob

For the defaults of IBP alarm limits, see Section 4 Alarm Setup.

IBP Alarm can be turned On or Off separately:

Main Menu  Rotate the knob IBP1/2 Press the knobRotate the knob

IBP Alarm  Press the knob


If recorder is installed, then set the No. 2 channel to be IBP1 or IBP2 in the
Printing Setup :

Main Menu Rotate the knob System Setup Press the knobRotate the knob

Printing Setup  Press the knob Rotate the knob Channel 2 Waveform Press

the knob SPO2/IBP1/IBP2/CO2/RESP Rotate the knob按 Press the knob

The above setup will remain after power off.

8.2 Transducer Connection

8.2.1 Transducer

IBP transducers in conformity with ANSI/AAMIBP23-1986 standards and with


sensitivity 5uV/V/mmHg shall be used. Check transducer cable before connecting it to
the device.

The device provides disposable and reusable transducers.

WARNING:Disposable transducer and dome is for single use only. Never attempt to reuse the
parts. Discard the used transducers and domes properly.

1. When the device is turned on, the IBP channel will display “No transducer” and
alarm sound can be heard.
2. Plug transducer cable into the IBP or IBP2 socket, and alarm will stop indicating
the connection is correct. The other end of the transducer cable is connected as follows:

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1 2 3 4 5
Fig. 8-1 IBP Transducer Connection Diagram

① The T (1) is used to make (2) to be open to the air.


② The T (3) is used to block (2) from (3) and (4).
③ The pressure monitoring tube (4) is to ensure the accuracy of the measurement.
④ The (5) in the above diagram is to connect patient catheter.

1. Fill in the catheter system from T (3) and make sure there is no bubble in the system.

2. Connect patient catheter to pressure monitoring tube, make sure there is no air in
catheter, pressure monitoring tube or transducer.

WARNING: If there is bubble in the pressure tube or transducer, please flush the catheter
system with physiological saline.

At the IBP socket, the mark indicates that the signal input part is highly
insulated and defibrillation protected and patient safety can be guaranteed. In the
electrosurgical procedure or defibrillation, the device will not be damaged.

8.3 Transducer Zeroing

Transducer zeroing is very important for accurate measurement. So zeroing shall be


performed regularly.
1. When the screen prompts “ Please do calibration”, user may enter IBP Setup to give
command:
Main Menu Rotate the knob IBP1/2 Press the knob IBP Zeroing  Press the
knob

If the zeroing mode is set to Manual, after the system prompts zeroing is correct, it will
pop out IBP Zeroing , now press the knob, you will enter IBP measurement status. If
the zeroing mode is set to Auto, after the system prompts that zeroing is correct, it will
automatically enter IBP measurement status without necessity for the user to confirm.

2. Then adjust the T (1) in Figure 8-1, make sure T(2) is blocked from air. Then adjust

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T(3), make (2) to get through to (4).

8.4 Troubleshooting

8.4.1 If IBP waveform channel displays “Calibration Error”, please re-enter


IBP Setup menu and press Zeroing key. If “Calibration Error” prompt still exists,
please replace transducer.

8.4.2 If IBP waveform channel displays“No signal received”, please turn off the
machine and turn it on again. If the prompt still exists, please contact your dealer.

8.4.3 If IBP display value has big difference from expected value, please perform
zeroing again by following the steps in 8.3 Transducer Zeroing before performing IBP
measurement.

8.5 Precautions

WARNING: When liquid get into the machine, please turn off the machine
immediately and contact qualified service personnel .

WARNING: When the monitor is connected to electrosurgical units, make sure


the transducers and cables shall not get contact with the electrosurgical unit. The
patient lead and conducting wire must be far away from the operating table and
other devices. Electrosurgical unit shall properly grounded.

WARNING: When defibrillator is used, make sure patient cable has no contact
with metal or other conductor or device grounding part. During defibrillation, do
not touch the patient, table or device.

WARNING:Make sure to use the recommended IBP cable and transducers and
accessories.

Caution: When several medical devices are used on the same patient, leakage current may
increase. It is recommended to let qualified personnel to test the leakage current before
making the connection.

Caution: The IBP cable socket is for connecting the IBP cable and shall not get
contact with other conductor or ground. Check IBP cable regularly. If found any
damage, it shall be replaced immediately.

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SECTION 9 SpO2 MONITORING

9.1 Introduction

To enter SpO2 Setup menu,


Main Menu  Rotate the knob SPO2  Press the knob
Then you can see the menu on the right.
Then enter waveform speed setup. Rotate the knob and press the
knob , you can set the sweep speed, in the same way, you can also
set the SpO2 alarm limits and pulse rate alarm limits and turn
alarm on or off.

For example, to set the SpO2 waveform speed:


Main Menu Rotate the knob SPO2 Press the knob Rotate the knob

Waveform Speed Press the knob 12.5/25.0/50.0mm/S Rotate the knob  Press

the knob
To set SpO2 alarm limits,
Main Menu Rotate the knob SPO2  Press the knob Rotate the knob

SPO2 High Limit  Press the knob Rotate the knob(increase or decrease the value)
Press the knob

For alarm limit default setting, see Section 4 Alarm Setup.

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9.2 SpO2 Sensor

Sensor Recommended usage


Adult finger sensor, reusable Insert finger in the sensor and make sure the
(BCI 3044 finger sensor) sensor covers the finger completely.

Universal Y sensor, reusable Apply Y sensor at a fleshy portion of the hand


or foot with the red light side on the top and
align the light source and detector. Then fix the
sensor with medical adhesive, and make sure it
is not over tightened.

Wrap sensor, reusable Apply the wrap sensor at a fleshy portion of the
hand or foot with the red light side on the top
and align the light source and detector. Then fix
the sensor with medical adhesive, and make
sure it is not over tightened..

9.3 Precautions

9.3.1 When neonatal SpO2 is measured, the measurement result may be affected by
patient motion or signal strength. We recommend the following as a reference:
(1)SpO2 pulse rate shall be within 10% of the heart rate.
(2)There should be a SpO2 waveform of 6 seconds without artifacts.
(3)Stable SpO2 reading shall have remained more than 6 seconds.

9.3.2 Each time before and after use, clean the SpO2 sensor surface with 70% alcohol
solution but do not immerse the sensor into the solution.

9.3.3 Please do not use SpO2 sensor if you found it damaged.

9.3.4 Do not radiate or ethylene chloride steam the SpO2 sensor.

9.3.5 The following factors may results in inaccurate SpO2 readings:


(1) If there are dyes in the blood such as methylene blue, indocyanine green, indigo red

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and fluorescent yellow.

(2) If there is excessive outside illumination in the place.

(3) Serious anaemia.

For skin ventilation of the patient, change the sensor position at least once every
twenty-four hours.

9.4 Troubleshooting

9.4.1 No SpO2 Reading

Failure Phenomenon: In the process of monitoring, there is no SpO2 waveform and


reading.

Check if there is red light in the sensor and if the arm is pressed or if the room
temperature is too low.

Solution: If there is no red light in the sensor, check the connection of the extension
cable. In cold area, try not to let patient’s arm to expose to outside. Do not use the same
arm for blood pressure and SpO2 measurement at the same time.

If the SpO2 channel displays “No signal received”, then it is the communication
problem between SpO2 board and the system. Turn off the machine and turn it on again.
If the problem still remains, then the SpO2 board needs to be replaced.

9.4.2 Intermittent SpO2 reading

Failure Phenomenon: SpO2 reading is intermittent.

Check if the patient has moved and if the extension cable is damaged.

Solution: Keep the patient steady. If SpO2 extension cable failed, replace it
immediately.

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SECTION 10 TEMPERATURE MONITORING

Temperature monitoring results are displayed in digit form only without waveform. The
temperature readings are displayed in Channel 9 on the right side of the screen. For the
alarm limits and defaults, see Section 4 Alarm Setup.

Connect temperature probe to patient and make sure the other end of the cable is
firmly inserted into the socket in the device. The screen will then display the
temperature reading.

Main Menu  Rotate the knob TEMP  Press the knob


Then you can enter the temperature setup menu as shown in the
right figure. To set the alarm limits and temperature units, please
operate the knob through rotating and pressing it.。

For example, to set the temperature unit:

Main Menu  Rotate the knob TEMP Press the knob Rotate the knob

Unit Setup  Press the knob ℃/℉  Rotate the knob Press the knob

To set the temperature channel and alarm limits:

Main Menu  Rotate the knob TEMP  Press the knob Rotate the knob

T1 High Limit  Press the knob Rotate the knob(Increase or decrease the value)
 Press the knob

WARNING:

1. Before performing temperature measurement, do not get the temperature


probe close to heat source. If it has been close to a heat source, then let it cool
down for 5 minutes before performing measurement.

2. When temperature probe is not connected or temperature probe falls off, the
monitor will stop the measurement and display ‘”----” in the parameter area
but without alarm sound. To ensure the patient monitoring, it is recommended
to check the connection of the temperature probe regularly.

3. We provide skin probes and rectal probes, which are not exchangeable.

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NOTE:

1. To ensure the contact between the probe and the skin, please let the patient hold
the probe tightly with his arm and close to armpit artery.

2. It takes 10 seconds for the temperature measurement to reach a steady value.

3. If you use a disposable temperature probe, please do not reuse it and discard it
properly.

4. Reusable probes can only be sterilized with alcohol. Do not steam it.

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SECTION 11 CO2 MONITORING (Optional)

11.1 CO2 Setup

CO2 setup function is mainly used to set CO2 measurement mode,CO2waveform speed,
waveform filled up or not, CO2 unit and the calibration switch selection of O2, N2O and
Desflurane in addition to CO2 related parameter alarm limits. CO2 Setup menu and
sub-menu are as follows:

CO2 setup menu work mode Waveform speed

11.1.1 CO2 Measurement Mode Selection

CO2 Measurement Mode:

---Standby

---Working

Working mode: If watertrap is connected, then system is in normal working mode. If


watertrap is not connected, the in the CO2 channel, “Watertrap not connected” will be
displayed and CO2 measurement cannot be performed.

Standby mode: System stops CO2 measurement and CO2 module is in low power
consumption status.

It is recommended to switch to Standby mode when CO2 is not measured.

To set working mode:

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Main Menu  Rotate the knob CO2  Press the knob Working Mode Press the

knob  Work/Standby Rotate the knob Press the knob

11.1.2 CO2 Waveform Speed Selection

CO2 waveform speed has 6.25、12.5、25.0mm/s available for selections.

Main Menu Rotate the knob CO2 Press the knobRotate the knob

Waveform Speed  Press the knob  6.25/12.5/25.0  Rotate the knob Press the
knob

11.1.3 CO2 Waveform Fill Up

To select to fill up CO2 waveform:

Main Menu Rotate the knob CO2  Press the knob Waveform Fill-Up Press
the knob

The respiration rate measured by CO2 module is displayed before the respiration rate measured by
thoracic impedance through ECG electrodes. Only when
①CO2 module is not connected
②CO2 module is in standby status
③ Watertrap is not connected, the respiration rate is the reading measured through thoracic
impedance.

CO2 waveform speed setting and fill-up selection are synchronous with the related respiration
waveform setting in the display setup, i.e., the setting of a parameter’s waveform speed and fill-up
may also set the speed and fill-up of another parameter.

11.1.4 Calibration

During CO2 measurement, if the concentration of O2, N2O or Desflurane the patient
inhales is over a certain value, it may affect the CO2 measurement accuracy and
compensation calibration must be performed. After turn on the compensation in CO2
setup menu, the monitor will perform compensation calibration for related gas.

When O2 concentration exceeds 50%, turn on O2 compensation.

When N2O concentration exceeds 12%, turn on N2O compensation.

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When Desflurane concentration exceeds 12%, turn on Desflurane compensation.

To turn on the compensation:

Main Menu Rotate the knob CO2 Press the knobRotate the knob

Gas Compensation Press the knob O2 /N2O /Desflurane Compensation Rotate


the knob Press the knob

11.1.5 Setting CO2 Display Unit

The monitor provides two CO2 units: mmHg and kPa.

The change of CO2 unit will be displayed with the CO2 parameter value, e.g. in
parameter area or trend table. The unit of blood pressure and the unit of CO2 are the
same. When one unit is changed, the unit of another parameter will change also.

To set CO2 unit:


Main Menu Rotate the knob CO2 Press the knobRotate the knob

Unit Setup Press the knob mmHg/kPa Rotate the knobPress the knob

After CO2 setup is completed, rotate the knob to Exit , press the knob and confirm to
exit CO2 Setup.

11.2 Precautions

11.2.1 Factors influencing CO2 measurements:

— Change of barometric pressure


— N2O, O2 and water vapor
— Calibration deviation
— Liquid pollution

12.2.2 Factors leading to inaccurate CO2 reading:

— Reuse disposable sampling line or watertrap


— Sampling line placement error

Note: Do not reuse disposable sampling line or watertrap.

12.2.3 Keep the CO2 sampling T as close as possible to the patient, at the patient side

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of the Y connector of the ventilator.

12.2.4 CO2 sampling gas shall be collected from the free flowing gas (not affected by
ventilator).

12.2.5 Make sure gas circuit does not leak.

12.2.6 When necessary, please use CO2 compensation function.

12.2.7 There shall be no water at the lower part of the tubing. Watertrap shall be
replaced in time. Sometime, watertrap has to be replaced every 15 minutes and
sometimes 48 hours.

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SECTION 12 RESPIRATION MONITORING

The monitor provides two respiration monitoring methods: thoracic impedance and
cannula monitoring. When ECG electrodes are placed on the arms, the impedance
respiration monitoring is not very reliable. See Section 6. Respiration can also be
measured through CO2 measurement module.

To enter respiration setup menu,


Main Menu Rotate the knob RESP  Press the knob
Respiration setup menu is as figure on the right. Where,
RESP Lead : If lead mode in ECG setup menu select Three
Lead, the lead selections available are RA-LA/RA-LL;
If lead mode select Five Lead, RA-LA/RA-LL/RL-LA/
RL-LL are available for selection.
RESP Gain : ×½ /×1 /×2 are available for selection. Through selecting respiration
gain, the respiration waveform can be zoomed in or out for convenient observation.
Waveform Speed : 6.25, 12.5, 25.0mm/S are available for selection.

Main Menu Rotate the knob RESP Press the knobRotate the knob

Waveform Speed Press the knob 6.25/12.5/25.0 Rotate the knob Press the
knob
To fill up RESP waveform :
Main Menu  Rotate the knob RESP  Press the knobRotate the knob

Waveform Filling Press the knob

Apnea Alarm :Operator can turn on/off Apnea Alarm as follows,

Main Menu Rotate the knob RESP Press the knobRotate the knob

Apnea Alarm Press the knob

Apnea Alarm Tim(e) :5/10/15/20……/120 seconds are available for Apnea Alarm
Time selection.
Main Menu Rotate the knob RESP Press the knobRotate the knob

Apnea Alarm Tim(e) Press the knobRotate the knob Press the knob

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If Apnea Alarm is ON, Apnea alarm will be triggered when system detect abnormity
according to Apnea Alarm Time setup. Apnea Alarm belongs to Emergency Alarm.
Medical personnel should watch out for Apnea alarm.

WARNING:Medical personnel should watch out for unsteady patient, cause frequent action may
make monitor alarm wrong or failure.

To set RESP alarm limits:


Main Menu  Rotate the knob RESP  Press the knob Rotate the knob

RESP Upper Limit  Press the knob Rotate the knob Press the knob

RESP Alarm :Operator can turn on/off RESP Alarm as follows,

Main Menu Rotate the knob RESP Press the knobRotate the knob

RESP Alarm Press the knob

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SECTION 13 ARRHYTHMIA ANALYSIS(Optional)

Arrhythmia analysis is one of the optional functions of UT4000F Pro. If this function is
installed, then in the system setup menu, you can see VPC Analysis…

ECG setup menu A System setup menu


VPC means arrhythmia. First VPC ON/OFF in the ECG setup menu A should be
selected, then enter channel setup menu which is in the system setup menu and select
VPC in waveform Channel 2, then in waveform channel 2, you can see “learning” for
several seconds, showing the system is establishing the patient’s ECG template. When
arrhythmia is detected, the corresponding segment of ECG waveform will become
frozen for observation. When other types of arrhythmia or the same arrhythmia occurs
in three minutes, the waveform will be updated and the ECG waveform corresponding
to the current arrhythmia will be frozen.

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Above the frozen waveform, the time, type and frequency within 1 minutes of the
arrhythmia are displayed at the same time.

When VPC analysis function is out of the way, select VPC learning start in the ECG
setup menu, then system will start learning, rebuild the patient’s ECG template, in order
to analyse VPC correctly.

UT4000F Pro stores total 24-second waveform data before and after the arrhythmia is
detected. The same abnormal waveform occurring repetitively is not stored. 200 groups
of waveform data can be recorded.
The patient’s arrhythmia records can be reviewed through VPC Analysis in the system
setup menu. In arrhythmia recall, the stored arrhythmia waveforms are displayed in
tabular form. In the table, the type of abnormal waveform, time of occurrence are
displayed. Abnormal waveforms can be searched and reviewed.

The thirteen arrhythmia phenomena that UT4000F Pro identifies include:

Bigeminy Trigeminy
Bradycardia Tachycardia
Ventricular Ectopic Beat V.E.B Pair
Ventricular Tachycardia S-T Abnormity
Arrhythmia Pause
Missed Beats R on T
VT>2

When arrhythmia outside the above 13 types occurs, it will display “Abnormity”.
When receiving very weak ECG signal and the VPC type cannot be identified, then it
will display “Signal weak”. After lead switch or lead off and re-applied, the waveform
channel 2 will display “Learning” for several seconds, showing that the system is
re-establishing the ECG template.

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SECTION 14 MULTI-GAS MONITORING(Optional)

14.1 General

Multi-gas module measures CO2, N2O, O2(optional) and one of the five anesthesia

gases(Halothane, Isoflurane, Enflurane, Sevoflurane, Desflurane). Each gas is


displayed in a monitoring channel, with waveforms of minimum inhalation volume
and maximum exhalation volume. In addition, a channel of anesthetic gas parameters
display all gas readings at the same time.

Note
Each channel displays only one gas each time.

Gas Measurement:

Infrared method is used in the multi-gas measurement.

Printing

The multi-gas module has manually operated printing and alarm triggered printing
functions.

While the alarm triggered printing function is turned ON, whenever there is an alarm,
the recorder will automatically print out the data and waveform of 1 seconds, 2
seconds or 3 seconds before the alarm. User may also set to print data and waveform
of 10 seconds, 15 seconds, 20 seconds or 30 seconds after the alarm. Or the user may
also press the printing start/stop key to stop printing.

14.2 Installation and Connection

Configuration:
Multi-gas module
Water trap (Entrance bacteria filter)
Gas sampling line
Standard gas tube connector (collector, TEE?)
Gas exhaust tube
Multi-gas module connecting cable
Anesthesia machine gas tube connector

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Multi-gas module

The front panel of Multi-gas module:

The front panel of Multi-gas Module: Water trap

Caution
In order to protect module from pollution and the accuracy of data measurement, a
water trap for filtering out the bacteria must be used. Without the filter, bacteria and
liquid may enter the Multi-gas module directly, resulting in pollution to the system,
occlusion and fault reading. Change the water trap in time to avoid occlusion after
monitoring a patient. Do not attempt to sterilize or clean the water trap.

The rear panel of Multi-gas module:

Front panel of module has: Multi-gas module connector & Exhaust outlet

Installation Procedures:

Multi-gas module is an external and independent part of the UT4000F PRO patient
monitor.

Caution
In order to ensure good ventilation of the module, please keep minimum 5cm from
each side from the wall or cabinet.

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Note
Do not let condensed water accumulate on Gas sampling line or water trap. It is
recommended to place the Multi-gas module in a place higher or in the same level of
patient position.

Connect multi-gas module to the UT4000F PRO patient monitor enclosure.

Multi-gas Exhaust

If N2O and/or other inspired anesthetic gas are used, make sure to avoid operating
room pollution. Once a gas sample is passing through the “multi-gas module”, it must
be sent to the anesthesia circuit. Otherwise it must be removed from the anesthesia
circuit.

Sending anesthetic gas to anesthesia circuit

To send anesthetic gas to anesthesia circuit, the following accessories are required:

An anesthetic gas exhaust tube


Anesthesia machine gas circuit connector

1.Connect one end of anesthetic gas exhaust tube to Anesthetic gas exhaust outlet.
2.Connect anesthesia machine gas tube connector to anesthesia machine patient
circuit (exhalation).
3.Connect the other end of anesthetic gas exhaust tube to the anesthesia machine gas
tube connector.

Exhausting Anesthetic gas

To exhaust anesthetic gas from anesthesia circuit, please connect exhaust gas clearing
system to the multi-gas module. The following accessories are required to be
connected:
An anesthetic gas exhaust tube
A “ventilator gas storage box”, with inhalation pressure no higher than
0.3~0.4mmHg,or an exhaust gas clearing connector.

14.3 Menu

Multi-gas Measurement Menu:

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Exit
Work Mode
Waveform Speed
Wave Filling
Apnea Alarm
Apnea Alarm Time
Unit
Co2*
N20
02
Choose Monitor Gas
HAL
ISO
ENF
SEV
DES

Work mode Select Standby mode or Measurement mode

Waveform speed Setup the speed of waveform

Wave filling Select to fill in waveform or not

Apnea alarm Apnea alarm On/Off

Apnea alarm time Setup apnea alarm time

Unit Select mmHg or kPa

Alarm limit Setup parameter alarm limits

Choose Monitor Gas Select HAL, ISO, ENF, SEV, DES

Work mode

Select Standby mode or measurement mode

Standby mode:To stop gas measurement

Measurement mode:To start gas measurement

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Waveform speed

Select display speed of each waveform

Apnea alarm

Apnea alarm function On/off

Apnea alarm time

Select Apnea alarm time. When apnea alarm is on, in a preset period of time, if no
breath is detected, alarm will be activated.

Note
The patient monitor has a smart alarm function. It will not activate alarm during the
period when the patient monitor is just powered up. Instead, it will only activate alarm
after it has detected breath and there is a stop in the breath later.

Unit

Select different parameter unit


Select mmHg or kPa

Alarm limit

Setup parameter alarm limits

Select gas

Select anesthetic gases

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14.4 Start Monitoring

1.When the patient monitor is powered on, the multi-gas module will be powered on
automatically. Then, connect patient and warm up the module.

2.Install the water trap in the water trap holder in the front panel of Multi-gas module.

3.Connect one end of gas sampling line to the water trap, turn it clockwise to make
sure it is connected tightly. To disconnect the water trap from gas entrance of
multi-gas module, turn the connector at the top of gas sampling line counterclockwise.

4.Connect the other end of gas sampling line to patient loop with standard gas tube
connector.

5.Connect anesthetic gas exhaust tube to the rear panel of module, and connect
“anesthesia loop” or “get rid of anesthetic gas” pipe.

6.Start Anesthetic Agent Monitoring


(1) Select corresponding display channel in setup menu after power on.
(2) From the display mode, switching to “Standby mode” takes about 2-3 minutes. In
standby mode, anesthetic gas can be measured.
(3) If inhaled anesthetic gas is to be measured, please select the corresponding
anesthetic gas in menu.
(4) Select “measure mode” in “work mode”, in a few seconds, Zeroing will be
displayed. Zeroing takes about 2 minutes, then it automatically enter measure
mode.
(5) In measure mode, the channels of the waveform and parameter display the
measured results of current sampling gas.
(6)When “standby mode” is selected, the multi-gas module will stop the
measurement.

Note
After power on or the first time switching from Standby to Measurement mode,
zeroing is required. The channel will display Zeroing for 4 seconds, and then start
zeroing which lasts for 2 minutes. After zeroing is completed, it will automatically
enter into measurement mode.

Note
In measurement mode, the channels of the waveforms and parameters display the
measurement results of current sampling gas.

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14.5 Display

Anesthetic gas parameter display consists:


Waveform: CO2 , O2, N2O, anesthetic agents

Parameter: The inhaled & exhaled CO2, O2, N2O, five anesthetic agents ( one

anesthetic agent per time).

Display Window:
EtN2O InN2O (v%)

60.0 62.0
EtO2 InO2 (V%)

30.0 32.0
EtCo2 InCo2 (kpa) RR(bpm)

5.2 0.1 20
EtNar InNar (V%)

EtNar InNar (v%) -- EtCo2 InCo2 (kpa) RR(bpn) EtN20 InN20 (v%) EtO2 InO2 (v%)

1.4 1.6 5.2 0.1 20 60.0 62.0 30.0 32.0


T1 ( C ) T T2 ( C )
37.0 1.0 38.0

Note
The waveform and reading of one anesthetic agent are displayed each time.

Gas Channel Window


Each gas has its own window, with the following items being displayed:
Waveform, reading of “in” and“et”.

Gas Channel Parameter Window


The gas parameter window displays measured parameters of CO2 , O2, N2O, and

anesthetic agents.

Note
If you have any doubt the accuracy of displayed value, check for leakage or occlusion
in the water trap and exhaust tube.

Note
If waveform seems to be abnormally flat, check the water trap and sampling line for
any leakage or occlusion. Replace the water trap or sampling line when necessary.

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14.6 Measurement

The measurement range and accuracy of each gas are as follows:


O2: 5.0~100 Vol.% + 3 Vol.%

CO2:0~10.0 Vol.% + 0.5 Vol. % or +12% rel

N2O:0~100 Vol.% + (2.00 Vol.%+8% rel)

Note
As the measurement range of O2 and N2O is large, the waveform change is

not as big as CO2 waveform.

Anesthetic Agents:

HAL:0~8.5 Vol.% + (0.15 Vol.%+15% rel)


ISO: 0~8.5 Vol.% + (0.15 Vol.%+15% rel)
ENF: 0~10.0 Vol.% + (0.15 Vol.%+15% rel)
SEV: 0~10.0 Vol.% + (0.15 Vol.%+15% rel)
DES: 0~20.0 Vol.% + (0.15 Vol.%+15% rel)

During measurement, each time only one anesthetic agent is displayed.

Select Anesthetic Agent

Select an anesthetic agent from the following:


HAL
ISO
ENF
SEV
DES

Note
In order to assure the gas measurement accuracy, the module will automatically start
calibration after continuous working for more than 2 hours. The calibration takes
about ten seconds. The channel will display “Zeroing”, and the parameter box will
display “--”. After zeroing is completed, it will return to normal measurement status.

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14.7 Alarm

Multi-gas module has alarms for parameter exceeding the preset limits, apnea alarm,
alarm for abnormal status and alarm triggered printing functions.

Note
Alarm can be turned off in the menu.

Alarm for Parameters Exceeding Preset Limits


Alarm will be activated when the measured parameter exceeds the preset parameter
alarm limits.

CO2 alarm limit setup


Default ET:8, 50, IN:0, 8
Range:0~76mmHg

N2O alarm limit setup

Default IN:50, 80
Range:0~100%

O2 alarm limit setup

Default ET:30, 70,IN:20, 80,


Range:5~100%

Anesthetic agent alarm parameter setup:

HAL Default ET:1.0, 3.0,IN:1.0, 3.0


Range:0~8.5%

ISO Default ET:1.0, 3.0,IN:1.0, 3.0


Range:0~8.5%

ENF Default ET:1.0, 3.0,IN:1.0, 3.0


Range:0~10.0%

SEV Default ET:1.0, 3.0,IN:1.0, 3.0


Range:0~10.0%

DES Default ET:1.0, 3.0,IN:1.0, 3.0


Range:0~20.0%

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Apnea Alarm

When apnea alarm is on, in the preset period if no breath is detected, apnea alarm will
be activated.

Note
The Multi-gas module and the patient monitor system have a smart apnea alarm
function. That is, there will be no alarm during the period when the patient monitor is
just powered on. It will only activate the apnea alarm after it has detected respiration
activities and later it identifies there is an apnea.

Note
Apnea alarm is a crisis alarm. So when apnea alarm occurs, the red light flashes.

Abnormal Status

Abnormal status refers to sampling line occlusion or water trap error.

Note
When there is any occlusion, leakage or damage in the gas channel, error message
will be displayed within 1 to 2 minutes after the abnormal status occurs.

Alarm Triggered Printing


When alarm triggered printing function is ON, whenever there is an alarm, the
recorder will automatically print out the data and waveform of 1 seconds, 2 seconds
or 3 seconds before the alarm. User may also set to print data and waveform of 10
seconds, 15 seconds, 20 seconds or 30 seconds after the alarm. Or the user may also
press the printing start/stop key to stop printing.

14.8 Cleaning and Maintenance

Multi-gas Module

Note
Prevent disinfectant or its odor from entering into the gas module through the tubing.
Otherwise the module performances may be degraded or damaged.

Accessories

Replacement Procedures:

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water trap: Disposable, for single patient use only.


Gas sampling line: Reusable
Standard gas tube connector: Disposable, for single patient use.
Anesthetic gas exhaust tube: Reusable, only needs to be replaced when broken. Make
sure the connection is tight when doing replacement.

Cleaning Procedures:
water trap: Do not attempt to sterilize or clean it.
Gas sampling line, and standard gas tube connector:
Before cleaning the sampling line and gas tube connector, please get the following
ready:
Distilled water
Citric acid compound liquid
Container-big enough to immerse the tube
Injector

Steps:
1.Flush out the granule residue in the tube with distilled water
2.Then, wash the tube with citric acid compound liquid, immerse the tube in citric
acid for 20 minutes. Make sure that the tube is fully immersed.
3.Wash the tube with citric acid compound liquid again.
4.Flush out the citric acid residue with distilled water.
5.Inject air into the tube with the injector to remove the remaining water. Do not use
compressed air.
6.Make sure the tube is completely dry before use it.

Anesthetic gas exhaust tube:


Cleaning: Wipe the tube with a piece of soft cloth damped in mild soap water, then
wipe it with a piece of dry cloth. Do not immerse it in any liquid.

Disinfecting: Wipe the tube with a piece of soft cloth damped in cold chemical
disinfectant. Do not immerse it in the liquid. After disinfecting, remove the residue
disinfectant with a piece of cloth and keep it dry.

Solution for Occlusion

Entrance Occlusion:
When entrance accessories (water trap, sampling line, standard gas tube connector)
are occluded or entangled, please

1. Replace the water trap


2. Check the sampling line for occlusion, entanglement and replace it when necessary.
3. Check the gas channel connector to see if water is accumulated. If necessary,
remove the liquid and change the connector position. Make sure the gas channel is

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connected correctly.

Exhaust System Occlusion:


When the exhaust accessories (sealing rings or exhaust gas tube) are occluded or
entangled, please
1. Check the exhaust system accessories for occlusion or entanglement. If necessary,
replace it.
2. Start Zeroing.

Common Occlusion:
When the gas inlet or outlet system accessories become occluded or entangled, first
check the exhaust system accessories for occlusion. If necessary, replace it. If after
exhaust accessories are replaced and occlusion still exists, please check the gas inlet
accessories for occlusion and replace it if necessary.

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Section 15 Cardiac Output(Optional)

I. General

UT4000F PRO patient monitor measures “blood temperature”, “cardiac output”,


“hemo-dynamic results” through thermo-dilution method.

Cardiac output measurement is to place a special floating catheter into pulmonary


artery through the peripheral vein. Then inject a certain volume of low temperature
injection. When the injected cold saline mixes with the blood as it passes through the
ventricle and into the pulmonary artery, the blood temperature will change. A
temperature curve over time is created as the pulmonary temperature initially falls,
then rises back to normal as warmer blood replaces the cooled injection. Then, the
computer calculates the amount of blood pumped per minute. From the curves of TB
changes before and after injection, and the heat balance principle, the cardiac output
can be obtained and then stroke output is obtained in accordance with the heart rate.

Before average cardiac output (C.O.) and Cardiac Index (C.I.) are edited, maximum
six times can be measured. If more than six measurements have been done before the
measurement results are edited, then, the oldest measurement value will be deleted.

II. CO Setup Menu

In the system menu, select “CO”, to enter the sub-menu:

CO Measurement
TB Upper Limit
TB Lower Limit
Alarm ON/OFF
Temperature Unit

CO Measurement: Enter CO measurement window.

TB Upper Limit: 43℃. Each step:0.1℃, default: 40℃.


TB Lower Limit: 23℃. Each step: 0.1℃, default: 34℃.

Alarm ON/OFF: select “ON” and “OFF”, to control TB alarm. During the
measurement, alarm is automatically off. After measurement completes, alarm is
automatically return to the settings prior to the measurements.

Temperature unit: C is for Celsius and F is for Fahrenheit. Blood Temperature Unit

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Changes with body temperature unit.

In the display area, there are Waveform box, Parameter box, Message box and Control
box.

Waveform box: Waveforms are displayed;

Parameter Box:
CO: Cardiac Output Measurement Results
CI: Cardiac Index
BT: Temperature of Blood
IT: Temperature of Injection

Calculation Constant:
Time of the current measurement of parameters:corresponding to the displayed
measurement time of parameters.

Control box:
Start: To start a measurement.
Cancel: Cancel a measurement which is in process.
X adjustment: Change X scale (time) to 0-30 seconds and 0-60 seconds. In the scale
of 30 second, start measurement. When it is more than 30, it will automatically be
adjusted to 60, which remains unchanged in the next measurement. It can be adjusted
to 30 manually.
Y adjustment: Change Y scale (temperature) to 0-0.5℃ and 0-1℃, 0-2.0℃.
Calculation: Enter CO calculation window.
Print: Print CO curve.
Setting:
Calculation Constant: 0-1, adjustment step 0.001, with initial data.
Measurement Interval: Time interval between two measurements: 0-300 seconds. This
time is used for making judgment whether it is ready to start measurement.
Injection temperature: 0-30℃ and Auto, each step 0.1℃.
Injection dose: 2, 5, 10cc
Height: m
Body weight: kg

TB Alarm Setup

Alarm ON/OFF: When ON is selected, then TB (temperature of blood) alarm is


indicated and saved. When OFF is selected, there will be a alarm-OFF indication
beside of TB.

WARNING
During cardiac output measurement, blood temperature alarm is inactivated.

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Alarm records: When ON is selected, printout will be done at the time when TB
(temperature of blood) alarm happens.

Alarm levels: There are three alarm levels, respectively, High, Medium and Low.
High level alarm indicates the most serious situation.

TB alarm upper limit/TB alarm lower limit: TB alarm happens when the temperature
of blood exceeds the upper or lower limit.

CO.CONST
CO. CONST (cardiac output constant) refers to the calculation constant related to the
catheter and injection volume. When a catheter is changed, the constant has to be
adjusted in accordance with the catheter manufacturer instructions.

WARNING
Make sure the calculation constant matches the catheter.

Injection temperature: Selecting “AUTO” or “MANUAL” represents a different


method of obtaining injection temperature.
Selecting MANUAL: The system reads the injection temperature input by operator
according to confirmed temperature.
Selecting AUTO: Injection temperature sensor is in the injection channel, supporting
the system to read injection temperature in real time. When injection temperature is
known, setting can be done directly on the “Injection temperature”.

Measurement time interval: The minimal time interval between two measurements.
The adjustment range is from 5 seconds to 300 seconds.

EXIT: Select Exit, you will return to the main screen.

III. Operation Procedures

Measurement Steps:

1.Connect the patient monitor to power mains.

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2.Plug CO catheter, temperature probe into the corresponding connectors as shown


in above picture. Now blood temperature is displayed.
3.Click and highlight module setup function and adjust the working parameters.

Warning
Make sure the computation constant used for measurement matches with the catheter
being used.
Do not use cardiac output interface cable in MRI environment.

Caution
If catheter is to be replaced, please follow the catheter instructions. Enter the catheter
computation data into CO.CONST.

4.Select CO measurement button in the CO select menu, “CO measurement


window” will pop up.

Caution
Please select the proper injection switch. Cardiac Output calculation is based on the
injection switch status at the end of measurement. So after injection switch is selected,
do not change it before measurement ends.

5.In accordance with the requirements, measurements can be done repetitively.


6.After measurement ends, enter CO window, and edit the measurement data. For
detailed editing procedures, see the following paragraphs.

Warning
Make sure the measurement computation constant matches with the catheter being

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used.

Note
During cardiac output measurement, blood pressure alarm is not activated. After
measurement ends, the alarm will be automatically activated.

Blood Temperature Monitoring

When CO is not measured, Blood Temperature


can be monitored. The thermistor at the end of
the catheter in the pulmonary artery is used to
monitor the blood temperature.

During the measurement, blood temperature is


temporarily off to prevent alarm error.
After the measurement ends, blood temperature
alarm is automatically ON.

In the CO parameter area, the current blood temperature is displayed.

During the measurement, blood temperature and injection temperature are displayed
at the same time in the “CO Measurement” window in the lower right corner.

If you are measuring more than one temperatures, you can also obtain temperature
difference.

Rotate the knobCO Measurement Press the knob

If enter “Blood Temperature alarm limits” window now, you can set the blood
temperature alarm limits.

If enter “Temperature unit”, you can set the unit of Blood temperature and TEMP.

CO Measurement

Warning
Make sure the accessories are in compliance with the medical device safety
requirements.

Warning
When using accessories, make sure to avoiding getting in touch with conductive
metal.

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CO Measurement Window

In the CO menu, select CO measurement button, then “CO measurement” window


pops up as follow,

In the CO measurement window, measurements can be prepared. If no CO transducer


is connected, then, message box will prompt “CO transducer off”.

Display contents in the measurement window:


 Measurement Curve
 Measurement Prompt Message
 Measurement Start Time
 CO: Cardiac Output Measurement Results
 CI: Cardiac Index
 BT: Temperature of Blood
 IT: Temperature of Injection
 Function keys in the measurement window

Caution
During cardiac output is measured, blood temperature alarm is not activated, which is
indicated by a mark at the side of the temperature value. In the process, alarm being
disabled is to prevent from error alarm. After measurement ends, alarm will be
activated automatically.

Start: To start a measurement.

Cancel: Press the key during measurement, the measurement will be terminated.
After measurement ends, press the key, the measurement results will be abandoned.

Print: Recorder will print out the measurement curve.

Y axis: Change Y axis (temperature) scale, there are total three grades: 0-0.5℃, 0-1℃,

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0-2.0℃, which can be adjusted in reference to the temperature difference. The smaller
the scale, the larger the curve.

X axis: Change X (time) axis scale, there are total two grades: 0-30seconds, 0-60
seconds. In the following measurements, X-axis is not allowed for any further
adjustments.

Calculation: Enter CO calculating window.

Setting: To setup other parameters of CO measurement.

Exit: Exit measurement window.

Note
If the message appears: Injection temperature exceeds the limit, that is, injection
temperature is over 30 ℃ . Please replace the injection before starting the
measurement.

Note
It is strongly recommended to start injection within 4 seconds after “START” key is
pressed.

Measurement Process
Firstly, enter setting to input following data,
Calculation Constant: 0-1, adjustment step 0.001, with initial data.
Measurement Interval: Time interval between two measurements: 0-300 seconds.
This time is used for making judgment whether it is ready to start measurement.
Injection temperature: 0-30℃ and Auto, each step 0.1℃.
Injection dose: 2, 5, 10cc
Height: m
Body weight: kg

Secondly, press “Start” to start a new measurement.

To return the blood temperature to normal before a new measurement starts, and
ensure the measurement accuracy, it is recommended to keep a certain period of time
between two measurements. The length of time can be set with the interval in the CO
setup menu. The time unit is second. Time is displayed in the measurement window. If
the time is not reduced to zero, it is impossible to start a new measurement.

Note
It is strongly recommended to wait at least 1 minute (or longer in accordance with
patient’s status) before a new measurement starts.

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Repeat the above procedures, until the preset measurements are completed.

Before calculating, maximum 6 measurements can be done. If more than 6


measurements are done, each time a new measurement is done, the first measurement
result will be erased.

After the 6th measurement, a message will appear, indicating no curve can be saved in
the memory any more. If you have done additional measurements, then:

If a curve in the “calculation” window is deleted, then, it will be the first to be


replaced.

If already 6 curves have been saved in the memory, when a 7th curve is saved, then the
oldest measurement result will be automatically deleted.

Calculate Cardiac Output

In the “CO measurement” window, select “calculation”, enter “Calculation” window


as shown in follow picture,

“Calculation” window displays maximum 6 values. The measurement number and


C.O. value are displayed above the curve.

Delete a curve
a. Move the highlighted area through the curves.
b. After select a curve, press the knob, monitor will be displayed “Delete or
not ? ” please choose Yes, to delete it from the calculation.

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Calculation Window Contents:


① Six curves and CO values of six measurements.
② CO average
③ CI average
④ Function keys in Edit Window

Note:
In the calculation window, the selected measurement results of each time are averaged,
the average values will be added to the CO in the hemodynamics menu, as basis for
hemodynamic calculation.

For the first time to enter calculation window, all the valid measurement results curve
and the CO values below the curves are highlighted, indicating that all of them are
taken in the averaging calculation. Move the cursor between the curves, press the
knob at a measurement result which does not meet the requirements, the curve will be
excluded from the averaging calculation.

IV. HEMODYNAMIC CALCULATION

Hemodynamic Calculation

In calculation window, select “Hemodynamics” to enter the hemodynamics


calculation window as shown in the follow picture. The entered parameters are
displayed in the window and the calculation results are listed.

Rotate the knob, when the cursor moves to an input parameter, you can select and
change the parameter. After all parameters are entered, select “Calculate”, the results
will be displayed in the window immediately. The selected records can be printed out
with the recorder.

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Enter Value: CO, MAP, CVP, PAM, PAW, hr


Calculation result: CI, BSA, SV, SVI, SVR, SVRI, PVR, PVRI, LVSWI, RVSWI

CI=CO/BSA
BSA=HT0.725*WT0.425*0.007184
SV=CO/HR*1000
SVI=SV/BSA
SVR=[(MAP-CVP)*79.92]/CO
SVRI=SVR*BSA
PVR=[(PAM-PAW)*79.92]/CO
PVRI=PVR*BSA
LVSWI=[SV*(MAP-PAW)*0.0136]/BSA
RVSWI=[SV*(PAM-CVP)*0.0136]/BSA

CO Cardiac output
MAP Mean Artery Pressure
CVP Central Venous Pressure
PAMAP Pulmonary artery mean artery pressure
PAW Pulmonary artery wedge pressure
hr Heart rate

V. Alarm Messages and Indications

Curve Prompt Message


If thermodilution curve is abnormal, in the C.O. Measurement Window, curve prompt
messages will appear.

1. “Noise exists on the baseline”:


If a ventilator is being used with the patient, it may create interference.

2. “Baseline shifts very much”


If a patient is recovering from chest operation, such phenomenon may occur. If
low-temperature anesthesia is used with the patient, when measurement is done, the
patient is being recovered to normal temperature, the curve may have such prompt
message.

3. “Multiple peaks”
Phenomenon caused by a wrong injection technique.

4. “Curve too long”


The curve fall time exceeds 15 seconds.

5. “Curve too short”

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Curve fall time is less than 0.5 seconds (if there is noise on the baseline, then, part of
the baseline may be regarded as dilution curve by mistake, then such message will
appear). Then, cardiac output calculation results may be inaccurate.

6. “Delayed injection”
If injection is done 15 seconds after “Start Cardiac Output Measurement” is pressed,
cardiac output calculation value may be inaccurate.

7. “Injection temperature too high”


If the temperature difference between the blood and the injection is less than 8℃, the
cardiac output calculation value may be inaccurate.

8. “Verify Calculation Constant”


Such message may occur when a new catheter or calculation constant is changed but
not confirmed by the Confirm key being pressed. Now press “Start Cardiac Output
Measurement”, the message will disappear.

Warning Messages

1. TB out of alarm limits

When TB value is out of alarm limits setup range, alarm will occur.

Upper alarm limits: lower limits---43℃


Lower alarm limits: 23℃---Upper alarm limits

2. CO transducer off

VI. Reasons for Measurement Error

 Physiological Reasons
Patient motion during measurement
Patient’s anxiety
Heart rate and heart beat change
Mechanical tools resulting in the change in cardiac output
Cardiac abnormality(Valvular insufficiency)
Shock
 Error related to catheter
Bladder inflation during measurement
Improper catheter position
Damaged catheter
 Injection error
Wrong catheter injection port being used

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Improper injection time


Inaccurate or inappropriate dosage
Inaccurate injection temperature
 Instrument error
Incorrect calculation constant
Instrument failure

VII. Maintenance and Cleaning

Precautions and Maintenance

Warning
Before cleaning the UT4000F PRO patient monitor or sensors, make sure to turn off
the machine and disconnect it from AC power mains.

CO Interface Cable Cleaning


1)If any tape residue must be removed from the cables, it is recommended to use
proper detergent for cleaning the adhesive tape. Make sure the damage to the
cable is reduced to minimum. It is not recommended to use acetone, alcohol,
ammonia water, chloroform, or other strong solution, which may in the long run,
damage the vinyl cables.
2)Soak a piece of foam in warm water or other proper detergent to wipe the cables
and keep them dry. Do not immerse cables into water.
3)Check each cable for erosion, damage or break signs.

Gas Sterilization
Gas sterilization must be used to realize complete sterilization.

Remove obvious dirt from the cable with the pre-stated methods. When ethylene
oxide gas is used for sterilization, cables should be completely dry in order to prevent
residue generation.

Make sure to observe the operation methods provided by the gas sterilization
materials.

WARNING
Never autoclave the cables or heat the cables to a temperature higher than 75℃(167
℉). Cables shall be stored in the ambient temperature range between -20℃ to 75℃
(-68℉ to 167℉). The cables shall be hung up or placed without tangle.

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VIII. Accessories

Floating Catheter: Edwards 93A-931HF-7.5F or compatible Floating Catheter.

CO Cable: Spacelabs P/N: 306655-001 or compatible CO cable.

Injection Temperature Probe: BD P/N:SP4042 or compatible probe.

Injection Temperature Probe socket: BD P/N: SP5045 or compatible socket.

Injector: Medex MX387 or compatible Injector.

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Appendix I Product Specifications

I. Safety

Standards IEC 60601-1-1990


Safety Class ClassⅠ, with internal power supply
Protection BF & CF
Device Continuous working non AP/APG device

II. Power Supply Requirements

Input Power Supply Voltage: AC 110 ~ 230V,50/60Hz


Input Power: ≤115VA
Fuse: Fuse socket label at back panel (two pieces).
Fuse type: T2.0AL, 250V ~
Battery Capacity: 12V/4AH. Charging time≥8 hours
Battery backup working time: ≥1.5 hours
Charging mode: Automatically charged (with charge protection feature)
While the device is powered by AC power mains.
Discharge Protection When powered by battery, the device will be
automatically powered off when the battery power is
almost used up.

III. Performance Specifications

1. ECG

Patient Safety Standards IEC 60601-1-1990


CMRR ≥100dB
Heart Rate Measurement
and Alarm Range 15 ~ 300bpm
Accuracy ±1bpm
Heart Rate Average 8 beats
ST Segment Range -0.8 ~ +0.8mV
ECG Display Channel 4 channels
Pacemaker detection/rejection:
Input voltage range: ±2mV to ±700mV
Input pulse width: 0.1ms to 2.0ms

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Interface AAMI 6-pin


Lead selection I, II, III (3-lead mode)
I, II, III, V, avR, avL, avF ( 5-lead mode)
Lead fault alarm Audible and visual indication
Input 3 or 5-lead ECG cable
QRS indicator Audible and visual (heart mark flashes)
Waveform memory 12 minutes
Sweep speed 12.5 /25 /50 mm/S
Amplitude selection X1/4, X1/2, X1, X2, X4, Auto
Trend 2 hours → 4 hours → 8 hours → 24 hours → 48 hours
72 hours → 96 hours →120 hours
Patient isolation Puncture voltage 4000 VAC 50Hz 60 seconds
Leakage current: <10μA
Frequency response Monitoring: 0.5~35 Hz (+0.4dB,-3.0dB)
Surgery: 0.5~20 Hz (+0.4dB,-3.0dB)
(Non calibration significance)
Patient drive current <10μA
Enclosure leakage current <0.1mA
Max. T waveform suppression capability 1.2mV
Heart rate alarm duration Less than 7 seconds
Aspect ratio 0.24 ~ 0.6sec/mV
Defibrillation protection Tested with 5kV
Recovery after defibrillation Less than 5 seconds

2. RESPIRATION

Measurement method: Thoracic impedance


Respiration rate measurement
and alarm range: 0 ~ 150 brpm±2brpm
Waveform speed: 6.25、12.5、25mm/S
Update time Approx. 2 seconds

3. IBP(Optional)

Measurement and alarm range -30~300 mmHg


Scale mmHg/kPa
Channel Single channel or double channels
Resolution 1 mmHg
Sampling rate 62.5 times/second
Baud rate 9600BPS
Trend storage time 120 hours
Trend resolution 1 time/10 second
Waveform speed 6.25, 12.5, 25mm/S±10%
Transducer sensitivity 5uV/V/mmHg

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Transducer type Disposable, Reusable, Disposable Dome


Update time Approx. 2 seconds

4. SpO2

SpO2 Measurement and Alarm range


0 ~ 100% Adult/Child/Neonate
SpO2 Average 8 beats
SpO2 Accuracy ±2%(70 ~100%) ,±3%(50 ~ 69%)
SpO2 Pulse rate 30 ~ 250bpm
SpO2 Pulse rate average 8 seconds
SpO2 Pulse rate accuracy ±2bpm
Update time Approx. 2 seconds
Pulse rate alarm limits 0 ~ 240bpm
Pulse sound Pulse sound indication
Sensor type Finger tip, universal Y, wrap
Internal LED waveform Infrared: 940nm
Red light: 660nm
Light power dissipation Infrared light ≤22.5 mW
Red light ≤30 mW
Pulse rate indication Digital

5. NIBP

Method Auto oscilloscope


Parameters SYS, DIA, MAP, Pulse rate
Scale mmHg / kPa
Operation mode Manual, Auto, Stat
Repeat cycle 110, 15, 30, 60, 90, 120,240,480 minutes
Measurement and alarm range
Systolic Adult/pediatric 30 ~ 254mmHg (4.0 ~ 33.9kPa)
Neonate 30 ~ 135mmHg (4.0 ~ 18.0kPa)
Diastolic Adult/pediatric 10 ~ 220mmHg (1.3 ~ 29.3kPa)
Neonate 10 ~ 110mmHg (1.3 ~ 14.7kPa)
Cuff pressure range Adult/Child 0 ~ 300mmHg (0 ~ 40.0kPa)
Neonate 0 ~ 150mmHg (0 ~ 20.0kPa)
Initial cuff inflation Adult/Child 170±10mmHg (22.7±1.3kPa)
Neonate 100±10mmHg (16.0±1.3kPa)
Deflation pressure 30mmHg higher than the last SYS
Cuff inflation rate Not greater than 50mmHg/sec
Measurement time Typical measurement time is 25 seconds
Max. 40 seconds
STAT: Typical measurement time is 20 seconds
Pressure display accuracy ±3mmHg

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BP pulse rate accuracy ±3bpm at 40~200bpm


±5bpm at 240bpm
Cuff Neonate, infant, small child, child, small adult, adult,
large adult

6. TEMPERATURE ( 2-channel)

Measurement and Alarm range 0 ~ 50℃


Probe Skin surface or rectal/Esophageal
Unit Celsius /Fahrenheit
Accuracy ±0.1 ℃
Resolution 0.1℃
Update time Approx. 1 second

7. CO2(EtCO2 & InCO2)(Optional)

Working mode Measurement, standby, auto


Measurement range 0 ~ 99 mmHg
Scale mmHg / kPa
Accuracy ±2 mmHg (0 ~ 40 mmHg)
±5%(41~ 76 mmHg)
±10 %(77~ 99 mmHg)
Resolution 1 mmHg
CO2 Respiration 0 ~ 150 brpm±2brpm
Waveform speed 6.25, 12.5, 25mm/S±10%

IV. Display
Display Color TFT LCD
Size 12.1"
Matrix 800(H)x 600(V) pixels
Display Channel 6 or 8

V. Recorder

Type thermal recorder


Printing mode Real-time & alarm triggered printing
of waveform and text
Resolution X-axis up to 800dpi, Y-axis 400 dpi
Printing channel 2/3 channels
Printing speed Auto/12.5/25.0/50.0 mm/S

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VI. Physical Specifications

Net Weight 7.95 kg


Gross Weight 11.5 kg
Dimensions 320 X 250 X 170 mm3

VII. Environmental Specifications

Temperature
Working 10 ~ 40℃
Storage and Transportation -20 ~ +55C

Relative Humidity
Working ≤80% (non condensing)
Storage and Transportation ≤95% (non condensing)

Barometric pressure
Working 86 ~ 106 kPa
Storage and Transportation 50 ~ 106 kPa

Specifications subject to change without prior notice.

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Appendix Ⅱ Maintenance

I. Patient Monitor

When the patient monitor needs to be cleaned, use soft cloth dampened in mild soap
water to wipe the patient monitor. Make sure do not let liquid flow into the machine.

▲ Before cleaning, make sure to disconnect the AC power to avoid shock or fire.

▲ Do not clean the any part of the patient monitor with acetone.

▲ Never autoclave the patient monitor. Do not stack on the patient monitor. Do not
immerse it into any liquid. Do not steam it for sterilization.

WARNING: If liquid is accidentally splashed on the patient monitor, please wipe


it dry and do not let liquid flow into the machine. If liquid has flown into the
machine, please turn off the machine immediately and contact qualified service
personnel.

▲ The screen can be cleaned with soft cloth dampened in alcohol. Never use
abrasive material, tools, brushes or any material which may scratch the screen.

▲ When finding any damage or malfunction of the patient monitor, please stop using
it and contact qualified service personnel.

II. Cuff and Sensors (SpO2 sensor)

Cuff and sensors are accessories in contact with the patient. So each time after use, the
cuffs and sensors shall be cleaned.

Check the reusable sensors and cuffs regularly. If any damage is found, please replace
them immediately and discard the defective accessories properly.

Sensors and cuffs shall be sterilized regularly with ethane oxide.

Each time after sterilization, check if the sensor is damaged. If yes, it shall be replaced
immediately.

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III. Patient Cable (ECG Cable, IBP Cable, SpO2 Extension Cable)

▲ Do not autoclave the patient cables.

▲ Each time before using the cable, please carefully check the cable to see if there is
any damage. If any damage is found on the cable, please replace it immediately
and discard it properly.

▲ Do not immerse the cables into liquid or let liquid flow into the electric connecting
part. When cleaning the patient monitor, wipe the cable surface with soft cloth
dampened in soap water or alcohol. Make sure no liquid flows into the
connectors.

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