Script - InfusomatSpace - 3.0 PDF

„Infusomat® Space “
Seminarscript
Version 3.0_GB
Overview Seminar workflow
1. „Preparation“
2
2. „Introduction
Introduction“
3. B. Braun Presentation
4. Quality assurance
5. General Info’s/risks of CI
6. System Overview
7. Service manual
8. Disassembly
9. Assembly
10
10. Service program and Calibration
11. Checking
12. Documentation und Certifying
HC-XX-DE08 | Service Department

Page CoE AIS | Infusomat SP | Page 1
1.3 Checklist Special-/Calibration tools Preparation
Disassembly/Assembly
• 2,5 Allen key (emergency door opening)

• Torx plus screwdriver (IP10, IP8, IP6)
(only T10 metric are Torx standard, door lock drive and metal frame)
• Box spanner 5,5 mm (for M3 nut)
• Flat head screwdriver
• ESD Kit
• Wrist line

1
Disposables
• Tubes/ lines (per device)

• three-way chock
• 1ml syringe
• aqua dest. or NaCl solution
• Catheter

Calibration/Checking/Others
• PC
• Interface line (PC connection Interface line)
• Service software
• Service plug
• Allen key 3mm (mech. pressure cut off)
• Measuring cylinder 25ml
• Stop watch
• Patient leakage current test adapter
• Manometer (pressure gauge)
• etc.

2
6. System Overview
6.1 In general
6 2 The Infusomat Space
6.2
6.3 Handling overview
6.4 Powering on
6.5 Start of Infusion
6.6 Customized Options
6.7 Activating functions
6.8 Alarm
6.9 Pump principle

6.1 In general System Overview

3
68 mm
68 mm
m
Weight of:
Perfusor = approx. 1,4kg
Infusomat = 1,4 kg

Infusomat Space
p
Perfusor Space
Perfusor- and Infusomat Space are offering exactly the same handling structure.

4
Save and easy transport via new developed

coupling
li mechanism
h i
• Up to 3 pumps can be stacked together
• Easy to handle fixation clip
release button

Pole Clamp (SP)
• Designed for fixing stand-alone

pumps to infusion poles and wall
Optional short
rail systems. infusion pole
• Up to 3 pumps can be carried with

1 clamp
Space clamp Rotation mechanism

for horizontal and
vertical adaptation of
the pumps

5
Pole clamp
Position 1:
The lever locks the handle
Position 2:
The lever releases the

handle

Power Supply
• Input: Rated Voltage 100….240V~ /50-60 Hz/

400mA
• Output: 12V DC / 1,25A
Integrated
handle
12 V
power supply

6
Power Supply
pp y
MSC =Multi Socket Connector

Clip for fixation at the

P l Cl
Pole Clamp
Power Supply
• Input:
Voltage 100….240V~
/50-60 Hz/ 550 mA
• Output: 12V DC / 1,67A Configurable by the user.

g or straight
90° angle g
connection possible

7
Euro-Plug UK-Plug
AUS-Plug
US-Plug

Mech. Concept Infusomat Space
Theme Infusomat fmS Infusomat Space

Tube Original Infusomat.. Space line (e.g. DC 2000)
Delivery direction vertical horizontal

Pump door masked User Interface = Pump door
Pump guidance linear- linear –

(3 spring
i lloaded)
d d) (3 spring
i lloaded)
d d)
Membrane- in front of pushers behind pushers
location (Line guide cover = removable)
Force transmitter 12 pusher - gliding 12 connecting rods
(bearing seated)

8
Mech. Concept Infusomat Space (continuing)
Theme Infusomat fmS Infusomat Space

Housing Metal plastic with Metal chassis
Used Techniques Sheet, die-casting, spray Outsert, die-casting, spray cast

cast
Air sensor Ultrasonic Ultrasonic (focused)
Pressure sensor spring element / induction force sensor

coil
Drop sensor light beam light beam
Anti Free- flow pusher pusher + set related anti free-

clamp flow clamp

Space PCA-Kit:
1 1 On demand Button
1.
2. 1 PCA-syringe holder lock
3. 1 Fixation band
4. 1 Fixation clip
Order data:
• Art.-Nr. 8713554
The actual PCA key is made out of metal.

9
6.2 The Infusomat® Space System Overview
6.2.1 Back
6.2.2 Bottom side
6.2.3 The Front

6.2.1 Back The Infusomat® Space
Cover of battery
Port for drop sensor compartment
P3
P3 P2
P2
P3 Socket for
P2 Socket for 12 V,
Guide rails connection with
Interface, PCA,
Space Control
nurse call

10
Th drip
The d i sensor
• Drip chamber adapter replaceable
depending on drip chamber size
• Infrared light pulse with about 1 A current
• Pulse frequency 1000 Hz
• Wide angle optic
• Shielding for a better EMC protection
(see production stamp)

Th crank
The k for
f emergency opening
i (only)
( l )
In every case turn the crank clockwise (only) like shown at the crank opening
(left side when looking at the front)

11
Battery
connector (P1)
Device feet
Battery pack

Battery pack
• More than 4 h operating time, at 100ml/h
• Recharging when pump is connected to mains
• Recharging time 6 h
• NiMH technology to minimize memory effects
• Cost saving because of battery maintenance mode to increase life

time (from SW C)
• Infusomat and Perfusor are using the same battery, this minimizes
risk of confusion

12
After battery is fully charged it switches from charging current to “trickle” charging
∆tp (t2-t1)=300sec. ∆tc (t3-t2)=9 sec.

A
t1 t2 t3 t

6.2.2 Bottom The Infusomat® Space
Type
plate
l t
Glued Seal

13
6.2.3 The Front The Infusomat® Space
Alarm indicators (yellow, Front door with motor-

red/green, blue) to show driven lock mechanism
the device status
Guide rails for stack ability

and sliding pumps together
Emergency door
opening slot
Back-lit key pad
Release lever Graphic display with high

resolution
Rubber feet for table
usage

6.2.3 The Front The Infusomat® Space
Pump-based anti-
free-flow
free flow clamp Upstream sensor
Line guide
cover
Release
mechanism of Anti-
Free-flow clamp
Downstream
pressure sensor
Air sensor incl.
Temp. sensor

14
Air Alarm
Single Bubble Alarm Air Rate Alarm

(1 h range)
Alarm value 1.5 ml/h (var. 0.5-3.8 ml/h)
(Standard)
Alarm value 0.3 ml (var. 0.01-0,3 ml)

(Standard)

6.2.3 The Front The Infusomat®Space
Infusomat SP S Infusomat SP P

15
Infusomat SP S Infusomat SP P

Door Jam
Door Jam
in combination
with the older
version of
extension hook
made of plastic
Kit „Door Jam“ article number: 3452 1489

16
New Metal front sheet
Order number metal front sheet outsert II, ISPS: 34521487

(contains all required parts)
New Metal Door Extension Hook

(only without Door Jam allowed!)


Additional sealing
Sealing at the rear side of the front sheet

17
Additional sealing - at the user interface

6.3 Handling Overview System Overview

Two pumps one user interface !! Special bolus key
for quick bolus
“C” key with double function: applications
1.go clear value input
2.go back into former menu ON/OFF key
Door open key

(only Infusomat)
Start-/Stop key
Graphic display
Communication key
Cursor for navigation and (PC ,Space Control or
value inputs OK key to confirm barcode data receipt
inputs

18
Anti-Freeflow-
Anti Freeflow Fixation hook of the
clamp Set related line pump segment
Fixation hook of the line

pump segment
Compartment for the

peristaltic pump, removable
for cleaning purposes

6.3 Handling Overview (line) System Overview
New Infusomat Space line
• New Infusomat Space line with integrated

Anti-Freeflow-clamp within the Set as
standard
• Continuing Freeflow-protection while removing

the set out of the pump
Against over dosage, to minimize dosage

failures.
Backward compatibility to Infusomat fm/fmS.

19
Pl
Please watch
t h th
the
respective Instruction
for use !

Relation between rate and alarm time

20
6.4 Powering on System Overview
Display with device off but with mains connected
- Battery status
- Activation of battery maintenance

(depends on the status and setting)
- Mains connection (if connected)
- Last therapy
- Service mode (if connected)
- Ward identification (if used)

6.4 Powering on System Overview
P
Press “O /Off” switch
“On/Off” it h on unit
it and
d note
t the
th automatic
t ti self
lf check:
h k
• Display shows “Self test active” (counts from 0 to 9)

• Software version is displayed
• Two audible tones sound
• All three LEDs (yellow, green/red and blue) flash once
• Information on power supply (battery or mains connection)
• Both set air alarm level are displayed (single bubble, cumulated)
• The tubing line (if already inserted) is displayed
• Last therapy

21
6.5 Start of Infusion System Overview
• Inserting an infusion set
• Recommended settings to start an infusion
• Observable things
• Emergency door opening

6.5 Start of Infusion System Overview
Inserting an infusion set and what to be aware of:

22
6.6 Customized Options System Overview
6.6.1 Occlusion Pressure
6.6.2 Data Lock
6.6.3 Date & Clock
6.6.4 Alarm Volume
6.6.5 Patient Data
6.6.6. Bolus Rate
6.6.8 Macro Mode
6.6.9. Help Texts

6.6.1 Occlusion Pressure Special Functions
Customized
Options
Occlusion Occlusion Pressure

pressure The occlusion pressure settings offer the
Data Lock possibility to set the optimal highest pressure
to reduce bolus volumes and alarm triggering
Date times in case of a closed infusion line.
Clock
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

23
6.6.2 Data Lock Customized Options
Customized
Options
Occlusion
pressure Data Lock
Data Lock Prevention against non-authorized
Date manipulations.
Clock
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

6.6.2 Data Lock Customized Options
Data Lock can be programmed in 2 levels:
Level 1:
No changes of values possible, stop, start, turning on/-off allowed
Level 2:
Same as Level 1, additionally no change of the disposable possible.

24
6.6.3 Date & Clock Customized Options
Customized
Options
Occlusion
pressure Date & Clock
Data Lock For documentation reasons and the
Date History Protocol.
Automatic adjustment if connected to
Clock
SpaceStation together with SpaceCom.
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

6.6.4 Alarm Volume Customized Options
Customized
Options
Occlusion
pressure Alarm Volume
The loudness of the audible alarm signal can be
Data Lock adjusted to the environmental conditions in
Date the hospital
Clock
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

25
6.6.5 Patient Data Customized Options
Customized
Options
Occlusion
pressure Patient Data
Data Lock are a safety feature which makes it possible to treat
the right patient with the right drug
Date
Clock
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

6.6.6. Bolus Rate Customized Options
Customized
Options
Occlusion
pressure Bolus Rate
The max.bolus rate can be limited for safety reasons
Data Lock If the bolus rate is set to zero the bolus
Date function is disabled.
Clock
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

26
6.6.8 Macro Mode Customized Options
Customized
Options
Occlusion
pressure Macro Mode
Individual adjustment of the display content.
Data Lock The user can decide if the delivery rate shall be
Date screened in big numbers or smaller.
Clock
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

6.6.9. Help Texts Customized Options
Customized
Options
Occlusion Help Texts

pressure Intuitive handling with or without help texts.
Data Lock Help texts make it easier for new users
to handle the pump and to reduce
Date
the risk of wrong handling.
Clock
Alarm Volume
Patient Data
Bolus Rate
Macro Mode
Help texts on

27
6.7 Activating functions System Overview
To activate/deactivate certain functions see „Service Program“
Overview:
- Bolus mode („Others“)
- Selection on initial startup („Language“)
- Bolus sound („Alarms“)
- Acoustic alarm in SpaceStation („Alarms“)

( Alarms“)
- Last therapy („Others“)
- Prime („Rates“)

6.8 Alarm System Overview

28
6.8 Alarm System Overview
1
1. Air alarm
2. Temperature alarm
3. Upstream pressure sensor
4. Downstream pressure sensor

6.8 Alarm (influences) System Overview
•Disposables
•etc.

29
6.9 Pump principle (general) System overview
The Infusomat SP is developed out of the Perfusor SP
The functional areas:

Power supply, alarm identification and - indication, User interface, Display, functional- and
control processor, watchdog and real time clock are build up identical to the syringe pump.
Also the motor controlling, the output stage and the movement detection is taken from the
syringe pump.
This is also valid for the relevant software functionalities.

6.9 Pump principle (Perfusor SP) System overview

User Interface
Acoustic Alarm-/Signal-LEDs
Watchdog Acoustic alarm via (Matrix)
Power supply alarm via
Loudspeaker
with monitoring piezo buzzer
(>65dBa)
(<65dBa) Graphic display
FµP & CµP FµP CµP CµP FµP

FµP CµP Fµ Cµ
FµP CµP FµP or CµP
P
serial
Functional- synchronic Control-
Stepper motor- Movement sensor
output stage (2 light barriers)
processor processor Real time clock
Driveend-
Position sensor FµP CµP (M32) (H8S)
Syringe size- 32kHz

12MHz 10MHz
detection Sensor
Motor axis (Potentiometer)
Syringe pump
drive
(stepper motor)
ur gear -gearing
spu
Claw sensor FµP

Spindle Nut Drive tube
(Torque Poti)
Claw motor FµP

DC-Motor- &
(DC-Motor)
Output stage
claw (s)
and gear Cµ
P
Syringe Strain gauge FµP
Syringe plate FµP

Sensor
Page CoE AIS |Syringe
Infusomat
holderSP | Page 69 (Light barrier) Cµ
P
30
6.9 Pump principle (Infusomat SP) System overview
Acoustic User interface
Acoustic alarm via Alarm-/Signal-LEDs
Watchdog (Matrix)
Power supply alarm via
with monitoring
Loudspeaker
piezzo buzzer
(>65dBa) Graphic display
(<65dBa)
CµP
FµP CµP FµP oder CµP CµP FµP Cµ

P
seriell
Functional- synchron Control- Real time clock
Processor processor FµP & CµP FµP CµP
(M32) (H8S)
32kHz
output stage (2 light barriers) FµP
12MHz 7,37MHz
FµP FµP CµP Test FµP

Drip
Sensor
Pumpenkopf
Temperature &
Downstream Peristaltic Upstream
Air
Sensor (Stepper motor) Sensor
Sensor
Tube
Front cover

6.9 Pump principle System overview
Actually the tube pump consists of:

tthe
e disposable
d sposab e (tube, drip
d p chamber,
c a be , reservoir)
ese o ) tthe
e pu
pumppuunitt a
and
d
the front cover as counter piece and pressing element for the pump peristaltic and the
sensors.
Additional we have the following sensors:

• Drip sensor to avoid an evacuation of infusion line or rather to detect a closed roller
clamp (as a further development of the Infusomat FM).
• Upstream sensor as a detection of an occlusion at the inlet tubing (negative pressure)
• Downstream sensor detection of an occlusion at the outlet side to avoid a tube rupture
(overpressure)
• Air and temperature sensor for detection of air bubbles inside the tubing (rupture or an
empty reservoir) and compensation of temperature depending tube parameters.

31
In order to support the user and to achieve a reproducible closing of the
pump cover the front cover will
b closed
be l d motor
t ddriven.
i FµP & CµP FµP CµP

output stage (2 light barriers) FµP
FµP FµP CµP Test FµP

Drip
Sensor
Pumpenkopf
Temperature &
Downstream Peristaltic Upstream
Air
Sensor (Stepper motor) Sensor
Sensor
Tube
Front cover
Schließriegel
Cover motor
FµP DC-Motor- FµP
(DC-Motor)
Linear potentiometer Output
CµP and gear
The position of the looking bolt will be detected and controlled via a linear potentiometer.
The circuit and the control equals the function of the syringe detection at the syringe pump.


For an easier insertion of the tubing set the locking bolt is pushing the pump
head back in open mode.
In order not to endanger the patient the anti free flow clamp is closing before any
pump head movement
FµP & CµP FµP CµP
FµP & CµP FµP CµP

output stage
Stepper motor- (2 light barriers)
Movement sensor
FµP
Pumpenkopf
Safety clamp Pumpenkopf
Sensor Peristaltic
Downstream (Stepper
e stamotor)
Peristaltic
tc
Sensor (Stepper motor
Tube
Front cover
Locking bolt
Cover motor
FµP DC-Motor- FµP
(DC-Motor)
CµP and gear

32
Occlusions test
Alignment of pressure sensors FµP & CµP

FµP & CµP
FµP CµP
FµP CµP

Movement sensor
Stepper motor-
output stage (2 light barriers
FµP FµP
Pumpenkopf
Safety clamp
Pumpenkopf
Peristaltic
sensor
Down stream (Stepper motor) Upstream
Peristaltic
Sensor Sensor
(Stepper motor)
Tube
Front cover
Locking bolt
Cover motor
FµP DC-Motor- FµP
(DC-Motor)
CµP and gear

6.9 Pump principle (locking bolt) System overview

Positions of the locking bolt:
1. Move toward dead stop (Poti left dead stop )

 pump door opens, set tolerance to zero – as a precondition for the ability to
detect the “door close” impulse (expected from the user)
2. Occlusion test (Pump occlusive)

(delivering a volume of approx. 0.5 ml against the closed anti Freeflow clamp – rise
in pressure expected!!)
3. Alignment of pressure sensors (Anti Freeflow clamp closed!)

 both pressure sensors are at the same level –
only influenced by the hydrostatic pressure
4. AF clamp is opening (pump unit remains occlusive)

33
7. Service manual
7 1 Overview
7.1
7.2 Specialties
7.3 Features
7.4 Updates

7.1 Overview Service manual
Chapter 0 to 10
Chapter 0 = Important preliminary remark
• „Who's allowed to do what?”
• Spare Parts and Calibration tools
• Addresses

34
7.2 Specialties Service manual
• Gold cap (0,1 F) life expectancy > 8 years
• Piezzo buzzer (buffered by the gold cap)
• RT Clock – buffered by the Gold Cap

(approx. 1hr without any power)
• Two voltage level inside the device

- 5V for all consumers (motors, light)
- 3,3V for the electronics

7.3 Features Service manual
• Amendment service
• Index/ directory
• Real pictures
• Exploded drawing
• etc.

35
7.4 Updates Service manual
Meaning of Software identification:
686 C 030001
type of device = Infusomat SP
group
subgroup
PFA E 00003 remember Perfusor fm
PFA E xxxxxx
= Infusomat SP
next sw group

7.4 Updates (SW Ident.) Service manual

688 X 03 …X
Family identifier, e.g. Perfusor Space
O
Ongoing
i character,
h t SW revision
i i (i(incl.
l IFU revision)
i i )
Hardware Index (incomp. triggering HW state)
State of Update
Device SW Code
Infusomat Space S 686………
Infusomat Space P 687………
Perfusor
f S
Space 688………
Space Control 689……….
Space Station 690……… No version display
Space Cover (comf.) 692………

Space Com 695……..
36
8. Disassembly
8 1 Required tools
8.1
8.2 The procedure

8.2 The procedure (overview) Disassembly
Part Disassembly is divided into the following demo/exercise phases
8.2.1 Demo/exercise phase A

- Opening Housing
- Remove lower part of housing
- Divide Main PCB (incl. UI) from Front/Pump unit
- User Interface
8.2.2 Demo/exercise phase B

- Front
- Frame
- Pump unit

37
8.2.1 Demo/exercise phase A Disassembly
Before turning off the device open the door!
• Remove battery
• Opening the device

User Interface Disassembly

38

User Interface (Pos. Upstream sensor) Disassembly

39
User Interface (Downstream, Air detector) Disassembly

Possible failures:
-incomplete characters on Display = Display defective
-Dark Display = bad line/ connection

40
8.2.2 Demo/ exercise phase B Disassembly
Front
• Remove slide guide cover
• Remove two pressure sensors
• Remove air/temperature sensor (clicked in)
• Remove membrane (be very careful - use only the thumb)
• Remove safety clamp (see next slide)

Anti free flow Clamp Disassembly

41
8.2.2 Demo/ exercise phase B Disassembly
Frame:
•Locking bolt motor (better to remove two screws completely)
•Locking bolt
•Pump Chassis
 remove two fixing clips
 press three springs (one unit)
 remove spring holder wing
 Springs now removable
•Divide chassis from frame

9. Assembly
9 1 The procedure
9.1
9.2 Caution
9.3 Typical faults (repetition)

42
9.1 The procedure Assembly
1. Mount front and pump unit together

be aware of the following:
- connecting rods (pleuel) (pointing upwards at first step)
- insert connecting rods very carefully into the membrane
2. Locking bolt motor (middle position helpful for assembling )
3. Set Pump unit with front upon the user interface
4. Plug in connectors (upstream- downstream- and DC motor-)
5. Mount Motion/Direction PCB (check free move ability)
6. Mount the pump unit (etc.) upon the Main PCB (plug in rubber cable from air detector
and stepper motor)
7. Assemble Frame with chassis (check gap between pump and main PCB - quiet
small!)

9.1 The procedure (continuing) Assembly
8. Replace lower part of the housing

- do
don'tt forget
o get the
t e device
de ce release
e ease lever,
e e , itt must
ust be inserted
se ted now
o
- be aware of the user interface spring
9. Insert the drop sensor connector into lower part of housing
10. thread the loudspeaker lead into frame and put the loudspeaker itself into housing
with soldering contact into housing gap
11. Connect Anti Freeflow clamp
12. Insert P2 and P3 into lower housing
13. Battery connector
14. Upper housing onto the device body (mind of click!!)

43
9.2 Caution Assembly
9.2.1 Upstream/Downstream sensor (screws not too fast)

9 2 2 Anti free-flow clamp:
9.2.2
- small part (inside clamp) in the corner and
- edge – black nose
 clamp fits in the frame only when released!!
9.2.3 Cable routing (door looking belt lead (black))
9.2.4 Chassis (parallelism of base chassis and frame and completely
pressed)
9.2.5 Housing (Loudspeaker, Drop sensor, snap in noses,)

9.2.2 Black nose Caution

44
9.2.3 Cable routing Caution

9.2.4 Chassis (parallelism) Caution

45
9.2.5 Housing Caution
When putting upper housing and lower housing together be aware of the following:
• Spring of release clip must be outside

• Loudspeaker is inside the intended guide and
• Loudspeaker lead is inside housing and
 the LP soldering contacts are in their intended position
• All connectors are in their intended positions
• Snap locking (front side) is closed

9.2.5 Housing (Loudspeaker) Caution

46
9.2.5 Housing (Loudspeaker) Caution

9.3 Typical faults (repetition) Assembly
1. Nose of drip sensor connector wrong direction

2. Co e g of
Covering o the
t e axis
a s between
bet ee user
use interface
te ace aand
d front
o t
3. Release lever forgotten
4. Cable routing (e.g. black over four single leads, ribbon cable)
5. Door spring
6. Position of main PCB shielding
7. Fixing whole of main PCB
8. Connections
9. Looking bolt – position when mounting
10. Looking bolt motor (Poti nose, force transmitter on spindle)
11
11. S f t clamp
Safety l – spacer
12. Others

47
10. Service Program and Calibration
10.1 In General
10.2 With Service Plug
10.3 The Calibration
10.4 Opportunities inside Service Program
10.5 Software Update

10.1 In general Service Prog./Calib.
• One opportunity to update Perfusor-/Infusomat Space is to perform a single pump

(serial- or via CAN cable)
• Second opportunity to update Perfusor-/Infusomat Space and SP Cover comfort as

well as for SpaceCom (depends on current device SW) is for several devices in
parallel (via CAN cable)
• For SpaceStation the update will always be performed serial

48
10.1 In general - CAN driver Service Prog./Calib.
New CAN driver:
 On Service CD V3.5 located in the tool folder, you will find CAN driver 4.14.
This driver is compatible with WIN 7
 The driver installation routine will detect an existing driver on your PC and will stop the
installation
 You need to uninstall the old CAN driver first before you install the new one
 The old (big) CAN Box is able to work with the latest driver
(see next slide with pictures of old/new CAN Box)

USB CAN Boxes
New Old New Old

49
Software compatibility with Windows Operating System

HiBaSeD 4.00 XP Vista -
HiBaSeD 5.1.0 XP Vista Win 7
Space Upgrade 1.43 XP Vista Win 7
The CAN driver need to be compatible too

 CAN driver below 4.14 (e.g 4.04) on service CD up to version 3.2
is compatible with XP, Vista only
 CAN driver 4.14 distributed with SW version J06 compatible with XP, Vista, Win 7

10.2 With Service Plug Service Prog/Calib.
Differences with Service Plug?
• Display of the complete software version during self-test (e.g. 686L030003)
• Operation alarms are mute (for servicing)
• All deactivated settings are accessible
• The „Service Info“ – mode is accessible (air detector, Temp. check)
• Pressure cut off is set to „mechanical“
• Service mode identification
• Activation of battery maintenance possible

50
10.3 The Calibration Service Prog./Calib.
The only thing which is going to be calibrated (state March 05) is the locking bolt.
1. Calibration always starts with closed anti Freeflow clamp!
2. Follow the question from the Service Software

10.4 Opp. inside Service Prog. Service Prog./Calib.
The taskbar inside Service Program:
• file (print/ save settings)
• extra (language setting of Service Program)
• tools (disposable editor, INI files)
• update (scan BUS, SpaceStation)
• help (info, compatibility)

51
10.4 Opp. inside Service Prog. Service Prog./Calib.
10.4.1.Disposables
10.4.2 Modification Data
10.4.3 Tests
10.4.4 History Viewer
10.4.5 Clone Data

10.4.1 Disposables Others in Service Prog.
Inside „Disposables“ you have the opportunity to create your own table of disposables,
adapted to your
you special
spec a needs/situation
eeds/s tuat o in you
your hospital!
osp ta
The procedure is similar to the one described in the Perfusor Space Script.

52
10.4.2 Modification Data Others in Service Prog
Documentation of customizations
 With HiBaSeD 5.0 the Modification
Data can be printed out in a clear design
 This document can be used for

documentation and signatures

10.4.2 Modification Data Others in Service Prog
Checklist for your changes
Within HiBaSeD 6.1.0 instruction manual a pump default setting list can be seen
and /or printed out for documentation of customized changes.
Abstract of the list:

53
10.4.3 Tests Others in Service Prog..
An additional testing function is available to support the troubleshooting.
A test will be started with “Initializing” the device (with device switched on!).
Within “Tests” following columns are accessible:
• Accu (= rechargeable battery)

• Motor
• Sensor
• Display
• K b d
Keyboard

10.4.4 History Viewer Service Prog./Calib.
You can choose the History viewer in the star up window of the Service Program
The Password to get the complete access to the History viewer (incl
(incl. „Service
Service Editor“)
Editor )
is “sp3”
The following columns were displayed:
• Device (all actions will be displayed)

• System (Service notices possible!)
• Keypad (check off Keypad)
• Alarms (display of device alarms)
With the button „from device“ the display will be updated!

54
10.4.5 Clone Data - Upload Service Prog./Calib.
Clone Data is intended to be used to upload an already created Drug Database

((or Modification data and/or Disposable
p data)) to one or several pumps.
p p
1. Use CAN Cable to build up a connection between

pump / Station and HiBaSeD
2. Choose Clone data (without Password)
3. Select pump(s) or Space Station to which the Drug DB should be uploaded
4. Select file which contents the desired Drug DB
5. By pressing „Start“ button (full screen mode) the file will be uploaded
6. Watch and check the Report - finished

10.4.5 Clone Data - Drug file download Service Prog./Calib.
„Clone“ function within HiBaSeD
1. Choose the respective pump
2. Choose „Read from Device“
move it into „working list“
3. Initiate read from device

55
10.4.5 Clone Data - Drug file download Service Prog./Calib.

10.5 Software Update Service Prog./Calib.
Caution:
For the SW Update please always read and carefully
follow the respective „Instruction for SW Update”
(see Software IFU J04)
To open the IFU pdf please

leave the presentation modus
and double click on this
document

56
10.5 Software Update – Before update Service Prog./Calib.
Hint:
During the update process the user specific settings (like “Option”,
Option , limitations of infusion
rates and so on) are going to be reset to the default setting.
 Affected settings are Modification data and the disposable articles as well as the drug
library (the following procedure is not valid for the drug library).
 To reactivate the user specific settings after a SW update it is

recommended to save the respective setting before the
update will be started.
 One option to save it is to use the “print” function

mentioned on the slide “10.5.2 Modification Data”
(see right picture)
 The disposable article setting has a print function as well.

10.5 Software Update – Before update Service Prog./Calib.
How to reactivate the previous saved user specific settings (after the SW update):
1. Connect the PC via CAN cable with a single Space pump
2. Open the matching HiBaSeD service program (usually a new, higher version) and
chose your pump within HiBaSeD
3. Take the previous saved hard copy of the Modification data (and/or the disposable
article data) and modify all respective settings.
4. Save the adapted “Modification data” as a file
5. Now the file can be taken to upload this settings to all other Space pumps which should
get the same settings (see slide 10.5.5 Clone Data - Upload)

57
Perfusor Space: SW Version Devices delivered from

688 C 03 0001 July 2005
688 D 03 0001 April 2006
688 E 03 0001 September 2006
688 E 03 0003 March 2007
688 F 03 0006 Mai 2008
688 G 03 0002 November 2008
688 H 03 …… 06/09
688 J 03 0006 2011
Use the proper Service Software for your device software!!


Relation between different SW versions and cables to be used.
N
No.: D i
Device S i
Service C bl to be
Cable b used
d for
f Drug li
D list
Software Program HiBaSeD editor
1. “C” 1.5.0 RS 232
2. “D” 2.0.1 RS 232 1.0
3. “E” 3.1.0 RS 232 or CAN 2.0
4
4. “F”
F 4
4… RS 232 or CAN 30
3.0
5. “G” 5… RS 232 or CAN 3.0
6. “H” 6… RS 232 or CAN 5.0
7. “J” 7…. RS 232 or CAN SpOS*1
*1 SpOS = Space OnlineSuite

58
10.5 Software Update – The procedure Service Prog./Calib
Divided in three main parts:
1. Update itself:
- Several pumps in parallel via CAN cable with SpSt and SpaceUpdate tool 
- Single update by use of Serial Space cable and the program
2. Adaptation of Calibration data depending on the update

(see 10.3 “The Calibration” – using HiBaSeD)
3. Adaptation of user specific data like “Modification Data”, “Disposable Articles” and
“Drug
Drug Library
Library” when required (use Clone function within HiBaSeD)
Hint: All the above mentioned sw tools respectively programs comes together as part of
the “HiBaSeD Service-CD” (Article number: 8713301).

10.5 Software Update – After update Service Prog./Calib.
IMPORTANT: After a successful update the following steps must be carried out !
1. After the pump has been used with the update program, the device must be switched
off and disconnected from mains power supply before it can be used.
2. After a successful update the User settings, Modification and Calibration data of the
device need to be re-adjusted with the HiBaSeD-Tool.

59
Modify device after Update
• Sometimes the Disposables and the Drug data has to be uploaded to the device,
even if they are not marketed in red (see complete “Instruction for SW Update”).
• After the updade of the user- and adjust data sometimes (see complete “Instruction
for SW Update”) a CalPatchAkku or a CalPatch.ini has to be uploaded to the pump.
Note: If you do not download the CalPatchAkku an operation of the pump in battery
mode might not be possible
• To have the same customized settings in the Space pumps like they have been
before the Software update it is recommended to take the setting print out from and

After all steps are carried out, finally the pump should run thru a functional test
to verify the correct operation.
operation
Test the device:
• Switch on the device and watch the correctness of the “Self-Test”
• Insert an infusion line into the pump and start the infusion.
• If no error messages or alarm are coming up

up, the conversion to the new
software has been successful.
• Check in the Menu “Status” of the pump if the software version of the pump is
like desired (e.g. 686 J 03 0006)
If no error messages or alarm are coming up, the software update has been successful!
60
Attention:
For calibration after the update from SW G direct to SW J please use for:
 Perfusor Space  “Modify”

 Infusomat Space  “New device”
For calibration after the update from SW E/F direct to SW J please use for:
 Perfusor Space  “New device”

 Infusomat Space  “New device”

10.5 Software Update – News in SW “J” Service Prog./Calib.
News for the user
 Therapy Modes:
- Ramp and Taper
- Multi Does Mode
- Program Mode
- Dose Over Time
 New Drug Library

 New dosing units
 Enhanced Piggiback
 Space Glucose Control (SGC)

61
10.5 Software Update – News in SW “J” Service Prog./Calib.
News for the technical staff:
 W-LAN Battery
 It is possible to load (download) an existing drug file from a single pump (new in
HiBaSeD)

How to downgrade Device Software
1. Downgrade is only possible pump by pump
2. The flow is:

a. Erase the existing pump software with “Perasemain.exe”
b. Update the Pump with e.g. the “SpaceUpdate-Tool”
3. Downgrade set up:
Serial cable SP
PC (No.: 8713234)
Space pump

62
How to downgrade Device Software
4. Process description to erase the pump software 
5. After the pump software has been erased it is important to initiate the connection
between the SpaceUpdate program and the device by pressing the on/off button for
several seconds (the update program will show the identified pump when connected) .
6. Update of the desired SW version is now possible

11. Checking
11.1 Checking after repair
11.2 Performing the TSC

63
11.1 Checking after repair Checking
• See list for check after repair (see SM page 3-43)

11.2 Performing the TSC Checking

For the following procedure use the SM (from page 7-1)
Electrical safety check

Measurement of patient leakage current is only done at the external power
supply, between primary connector (with shortcut) and the secondary
connector (with shortcut between pin 6, 7,12,13).
1. Mains connection
2. Primary side
3
3. Secondary side
4. Test adapter (SP)
5. Measuring device

64
Electronically pressure measurement (Down-/ Upstream)
In general:
Measuring- and cut off values are only valid when using a new (unused) tubing set!!
The electronic pressure cut off is realized via force sensor
Caution:
Don't stress the sensors with hard objects.
Forces over 15N leading to damage of the sensors

Adjustment of the mechanical pressure cut off
Attention:
When inserting the 3 mm allenkey be
aware not to damage the loudspeaker!
Test setup for mechanical pressure cut off adjustment

65
Air sensor
The air sensor check will be done in the „Service Info“ - mode!
Connect service plug to device and press the „“ key inside the line changing
menu.
•The Display will show „Air sensor“.

•The measuring value of the sensor will be displayed in mV.
•Additional to this the tube temperature will be displayed.
Hint:
The air alarm triggering depends on the adjusted sensor sensitivity for single
bubble and for cumulated air alarm.


Pressure cut off
The special function “Bolus reduction” reduces the pressure within the tube
automatically when reaching the cut off limit so
 have an eye on the manometer while checking it!!
Measuring- and cut off values are only valid when:

- using a new (unused) tubing set!! and
- at room temperature between 20 C – 25 C !
Start stopwatch and Infusomat Space device simultaneously.
Stop time measuring when reaching the 25 ml mark.
A deviation from 3,6 sec equals approx. 1 % within the relevant area.

66
Delivery accuracy
For example:
25 ml of fluid has been delivered at a rate of
250 ml/h within 5 min. 42,0 sec.
 the delivery speed is to high (+5%)!
How do you have to modify the delivery

constant in order to correct it?
The delivery constant in the HiBaSeD has to

be set to ____ to achieve a 0% deviation!
(the same principle like in the Inf fm/fms)

11.2 Performing the TSC - A Checking

Delivery accuracy
For example:
25 ml of fluid has been delivered at a rate of
250 ml/h within 5 min. 42,0 sec.
 the delivery speed is to high (+5%)!
How do you have to modify the delivery

constant in order to correct it?
The delivery constant in the HiBaSeD has to

be set to + 5% to achieve a 0% deviation!
(the same principle like in the Inf fm/fms)

67
Typical measuring mistakes
Reading mistake: Tube is hanging down Flask is closed!!

in the solution:
 the lowest point  smaller delivering-
should be read!  finish too early! rate!

Correct Measuring Installation!
OK!!

68
12. Documentation und Certifying
• summary
• open questions
• certificates for the students,

69

Script - InfusomatSpace - 3.0 PDF

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„Infusomat® Space “

HC-XX-DE08 | Service Department

1.3 Checklist Special-/Calibration tools Preparation

• 2,5 Allen key (emergency door opening)

HC-XX-DE08 | Service Department

• Tubes/ lines (per device)

HC-XX-DE08 | Service Department

1.3 Checklist Special-/Calibration tools Preparation

HC-XX-DE08 | Service Department

HC-XX-DE08 | Service Department

6.1 In general System Overview

HC-XX-DE08 | Service Department

HC-XX-DE08 | Service Department

6.1 In general System Overview

HC-XX-DE08 | Service Department

Save and easy transport via new developed

• Up to 3 pumps can be stacked together

• Easy to handle fixation clip

HC-XX-DE08 | Service Department

6.1 In general System Overview

Pole Clamp (SP)

• Designed for fixing stand-alone

• Up to 3 pumps can be carried with

Space clamp Rotation mechanism

HC-XX-DE08 | Service Department

The lever locks the handle

The lever releases the

HC-XX-DE08 | Service Department

6.1 In general System Overview

• Input: Rated Voltage 100….240V~ /50-60 Hz/

• Output: 12V DC / 1,25A

HC-XX-DE08 | Service Department

MSC =Multi Socket Connector

HC-XX-DE08 | Service Department

6.1 In general System Overview

Clip for fixation at the

• Output: 12V DC / 1,67A Configurable by the user.

HC-XX-DE08 | Service Department

HC-XX-DE08 | Service Department

6.1 In general System Overview

Mech. Concept Infusomat Space

Theme Infusomat fmS Infusomat Space

Delivery direction vertical horizontal

Pump guidance linear- linear –

HC-XX-DE08 | Service Department

Theme Infusomat fmS Infusomat Space

Used Techniques Sheet, die-casting, spray Outsert, die-casting, spray cast

Pressure sensor spring element / induction force sensor

Anti Free- flow pusher pusher + set related anti free-

HC-XX-DE08 | Service Department

6.1 In general System Overview

The actual PCA key is made out of metal.

HC-XX-DE08 | Service Department

6.2.2 Bottom side

6.2.3 The Front

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6.2.1 Back The Infusomat® Space

HC-XX-DE08 | Service Department

HC-XX-DE08 | Service Department

6.2.1 Back The Infusomat® Space

HC-XX-DE08 | Service Department

HC-XX-DE08 | Service Department

6.2.1 Back The Infusomat® Space