Script - PerfusorSpace - 3.0 PDF

„Perfusor® Space “
Seminarscript
Version 3.0_GB
Overview Seminar workflow
1. „Preparation“
2
2. „Introduction“
I t d ti “
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. Service program and Kalibration
11. Checking
12. Documentation und Certifying
HC-XX-DE08 | Service Department

Page CoE AIS | Perfusor SP | Page 1
1.3 Checklist Special-/Calibration tools Preparation
Disassembly/Assembly
 Torx plus screwdriver (IP10, IP8, IP6)

 Flat head screwdriver
 Circlip Pliers
 ESD Kit
 Wrist line

1
Cross section

Disposables
• Syringes (per device): 1x 50ml OPS
1x 30ml (Omnifix)
1x 20ml OPS and/or Omnifix
1x 10ml (Omnifix)
1x 5ml (Omnifix)
1x 2ml (Omnifix)
• Competitor syringes (relating to those used in your markets)
• Original Perfusor Line (one per device)

2
Calibration/Checking/Others
• PC
• Interface line (PC connection Interface line)
• Service software
• Service plug Space
• Syringe gauge PSP (with motor power test adapter and plate)
• Length gauge PSP
• Diameter gauge kit (32mm, 23,4 mm, 15,7mm, 9,0 mm)
• Test adapter EL_S (leakage current)
• PCA Key
• DC generator or battery (piston brake disassembly)

6. System Overview
6.1 In general
6 2 Th
6.2 The PPerfusor®
f ®S Space
6.3 Handling overview
6.4 Powering on
6.5 Start of Infusion
6.6 Special functions
6.7 Activating functions
6.8 Alarm
6.9 Drive (principle drawing)

3
6.1 In general System Overview


68 mm
68 mm
m
Weight of:
Perfusor = approx. 1,4kg
Infusomat = approx. 1.4 kg

4
Infusomat Space
p
Perfusor Space
Perfusor- and Infusomat Space are offering exactly the same handling structure.

Save and easy transport via new developed

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

5
Pole Clamp (SP)
• Designed for fixing stand-alone

pumps to infusion poles and wall
rail systems. Optional short
infusion pole
• Up to 3 pumps can be carried
with 1 clamp
Rotation
mechanism for
horizontal and
vertical adaptation
of the pumps
Space clamp


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

handle

6
Repair Kit Pole Clamp SP

34774380 (for 5 Pole clamps incl. instruction)

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

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

7
Power Supply
MSC =Multi Socket Connector

Clip for fixation at the

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

90° angle or straight
connection possible

8
Euro-Plug UK-Plug
AUS-Plug
US-Plug

New Pole clamp connector
Article number Kit (á 10 pcs.): 34774395

9
New Power Supply

New Power Supply

10
Accessories: connection to staff-call system

y
The cable will be delivered without

connector. 1,5 kV Isolation.
Adaptation to the Staff call System in the
hospital is required.
8713232 Connection Lead

for Staff Call SP

PCA KIT
1 3

11
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 latest PCA key is made out of metal

PCA-protection cap set:
• for Perfusor Space
• for a safe removal protection of

50 cc syringes
lock screw
• 4 caps in one set (incl. lock key for syringe holderl
new (green)
Order data:
• Art.-Nr. 8713556 /4 Stck.

12
6.2 The Perfusor® Space System Overview
6.2.1 Back
6.2.2 Bottom side
6.2.3 The Front

6.2.1 Back The Perfusor®Space
Cover of battery
compartment
P3
P3 P2
P2
Guide rails
Socket for Socket for 12 V, Interface,
connection with PCA, nurse call,
SpaceControl Service connector

13
Data communication inside Space
C = Controller
A = Area
N = Network
1. Only when the CAN is detecting a vis-à-vis (counterpart)

it is opening its interface, otherwise it protects itself against environment
2. The CAN bus has to be closed with a 120 Ohm resistor (e.g. SpaceCover)
3. The alarm indication is realized via CAN
4. One part of the CAN addresses (for the pumps) is the serial number

Battery
connector (P1)
Device feet
Battery pack

14
Charge controller
µController >10% 50% 80%

and memory
Pump
interface
Pre-alarm: 30 minutes
Temperature
sensor

Battery
yppack
The pack can be easily removed and exchanged on the ward.
 More than 8 h operating time, at 25ml/h

 Recharging when pump is connected to mains
 Recharging time 6 h (to 100% capacity)
 NiMH technology to minimize memory effects
 Cost saving because of battery maintenance mode to increase life
time (from SW C)
 Perfusor,
P f I f
Infusomat t and
d SpaceCover
S C are using
i ththe same b
battery,
tt
this minimizes risk of confusion

15
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

Battery fixation (see Service Manual PSP chapter 3)

16
6.2.2 Bottom side The Perfusor®Space
Glued Seal
Side wall screw
PCA Lock
Type plate

The Seal's Meaning
• The seal stickers are intended to be used for B.Braun - Hospital Care
Devices only
only.
• The Seal number is exclusively for your Personal use (related on your
name) and not transferable
• The Seal number are only allowed to stick on devices which you have been
trained on (normally by a B|BRAUN certified Technical Trainer) and which
intended to be sealed.
• An intact seal upon the device says that after your sealing, there weren't
anyone who's opened it
following page

17
The Handling of the Seal
• After quitting the job as a service engineer, please send us (Technical Training
Dept.) an information about it and destroy
your remaining seal stickers.
• In the moment you are receiving a new seal number all probably existing older
seal numbers on your name are invalid.
Those older numbers are going to be deleted at BBraun
• Eventually remaining invalid seals have to be destroyed by yourself
• Changing your employer does not affect the once assigned seal sticker
number (keep in mind that a changed e-mail
e mail address has an impact to your
“Service Portal” access).
• Please order your Seals like you order your Spare Parts (when ordering,
please write your Seal number as clear as possible)
The seals are now available with the following article
code: 3477 4385.

6.2.3 The Front The Perfusor®Space
Signal LED´s (yellow,

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

and sliding pumps together
Front door with

magnifying glass
Syringe holder with

integrated piston brake Drive Head made of shock
resistant material, incl.
emergency release

18
6.2.3 The Front The Perfusor®Space
The Backlight is realized with 7

LED's, series connected
- 3 LED for the Syringe illum.
User Interface backlight
- 4 LED´s for the Keypad
Syringe illumination

6.3 Handling Overview System Overview

Two pumps one user interface !!
Special bolus key
“C” key with double function: for quick bolus
1. to clear value input applications
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 to SpaceControl or
value inputs OK key to confirm barcode data receipt
inputs

19
6.3 Handling Overview (P. Brake) System Overview
The benefits are:
• No free-flow during syringe

change if patient connection was
not interrupted
• No bolus infusion during syringe
change
• Optimal start-up characteristics at
g
low infusion rates for higher
therapy safety

Syringe with integrated piston brake

20
Pl
Please watch
t h th
the
respective Instruction
for use !


21
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
Press “On/Off” switch on unit and note the automatic self check:
• Display shows “Self test active”

• Software version are displayed
• Two audible tones sound
• All three LEDs (yellow, green/red and blue) flash once
• Information on power supply (battery or mains connection)
• Set pressure level is displayed
• The syringe (if syringe already inserted) are displayed
• L t therapy
Last th
• The drive moves automatically backwards
• Check of claw/push button

22
6.5 Start of Infusion System Overview
• Inserting
I ti a syringe
i
• Recommended settings to start an infusion
• Observable things
• Emergency release button

6.5 Start of Infusion System Overview
Two pumps one user interface !!

bolus key
“C” key with double function

ON/OFF key
Door open key

(only Infusomat)
Start-/Stop key
Communication key
Arrow field
OK key

23
6.6 Special functions 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

24
6.6.1 Occlusion Pressure Special Functions
Occlusion pressure
L
Length
h and
d di
diameter iinfluence
fl the
h pressure
Catheter, needle Filter Tubing
Pressure
[bar]
∆p

6.6.2 Data Lock Special Functions
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

25
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.


26

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

27
6.6.4 Alarm Volume Special Functions
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

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

28
6.6.8 Macro Mode Special Functions
Customized
Options
Occlusion
Macro Mode
pressure
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

6.7 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“)
- Last therapy („Others“)
- Prime („Rates“)

29
6.8 Alarm System Overview

6.8 Alarm (pressure principle) System Overview
1
1. St i gauge
Strain
2. Motor power limitation

30
6.8 Alarm (influences) System Overview
• Disposables
• Relative device position
• etc.

6.9 Drive (principle drawing) System Overview

FµP
FµP & KµP FµP KµP FµP
seriell
Functional- synchron Control-
Stepper motor- Movement sensor Driveend- processor processor Real time clock
output stage (2 light barriers) Position sensor (M32) (H8S)
FµP KµP
32kHz
Syringe size- 12MHz 10MHz
Sensor
Motor axis
(Potentiometer)
Syringe pump
spur gear -gearing
drive
(stepper motor)
Claw sensor FµP

Spindle Nut Drive tube
(Torque Poti)
Claw motor FµP

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

Sensor
Syringe holder (Light barrier) Kµ
P

31
7. Service manual
7.1 Overview
7.2 Specialties
7.3 Features
7.4 Updates

7.1 Overview Service manual

Chapter 0 = Important preliminary remark
- Service Work
- QM
- Setting Off
- Contact Persons
Chapter 1 = System Overview

- Function
- Block Diagram
- Accessories

32
7.1 Overview (continuing) Service manual
Chapter 2 = Unit Diagnosis / Calibration

- req.
req equipment
- table (new)
- alarms
- checking device (new)
- calibration
- troubleshooting (new)
Chapter 3 = Disassembly/Assembly
- before switching off device
- special screws
- service parts and screw kit
- Assembly: from subtopic 3.11
- Check after repair

7.1 Overview (continuing) Service manual
Chapter 4 = Servicing the Unit

Ch t 5 = T
Chapter Technical
h i lS Safety
f t Ch
Checkk (P
(Pump))
Chapter 6 = Technical Safety Check (Power Supply)
Chapter 7 = Procedural Instructions on the TSC
Chapter 8 = Test Equipment and Special Tools
Chapter 9 = Spare Parts List
Chapter 10 = Revision Documentation (new)
Chapter 11= Index (new)

33
7.2 Specialties Service manual
• Gold cap (0,1 F)
• 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
3 3V for the electronics

7.4 Features Service manual
• Revision service
• Index/ directory
• Real pictures
• Exploded drawing
• etc.

34
7.5 Updates (SW Ident.) Service manual
688 C 030001
device
d i = Perfusor
P f SP
group =C
subgroup= 030001
PFA E 00003 remember Perfusor fm
PFA E 00003
Device = Perfusor fm
group =E
subgroup= 00003

7.5 Updates (SW Ident.) Service manual

688 X 03 …X
Family
y identifier,, e.g.
g Perfusor Space
p
Ongoing character, SW revision (incl. IFU revision)
Hardware Index (incomp. triggering HW state)
State of Update
Device SW Code
Infusomat Space (S) 686………
Infusomat Space
p P 687………
Perfusor Space 688………
Space Control 689……….
Space Station 690……… No version display
Space Cover (comf.) 692………
Space Com 695……..
35
8. Disassembly
81R
8.1 Required
i d ttools
l
8.2 The procedure

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

(Flow: Modification with closed device  opening housing  the interior)
8.2.1 Demo/exercise phase A

- User Interface
- opening,
- Piston brake
8.2.2 Demo/exercise phase B

- Drive
- Main PCB
8.2.3 Demo phase C

- Drive head

36
8.2.1 Demo/exercise phase A Disassembly
• User Interface  mind of - the PCA eccentric

- the foil cable
- length of screws (rear side)
• Opening the device  before turning off the device let the
drive head move to „end position“!
(SM page 3-1)
• Piston brake  Sharp edge, 3V supply

User Interface Disassembly
Possible failures:
- Incomplete characters on display = display defective
- Dark display = bad line/ connection

37
Piston Brake (complete unit) Disassembly

Piston Brake (Syringe Holder) Disassembly

Focus on the aspects of:
• Stiffness (for more accurate syringe size detection) and
• Flexibility (kind of shock protection)
Mind of
this edge
stiff
flexible

38
Piston Brake (Cable routing) Disassembly

Piston Brake Drive Disassembly

39
8.2.2 Demo/exercise phase B Disassembly
• Drive After any kind of intervention a calibration is

required (SM 3.12 “Check after repair”)
• Main PCB

Syringe wing fixation

40
Drive Disassembly
• Complete
C l t DDrive
i
• Locking
• Drive Head cable
• The Nut

Drive (complete unit) Disassembly

41
Side wall special Disassembly
- seal material is a relatively hard PE foam (similar to that used in the crown corks)
Seal
Side wall

Side wall Disassembly
The green marked areas has to be lubricated with High

Vacuum Silicone grease (produced by company „Merck
Merck“,
already know from the Perfusor fm)

42
Side wall Disassembly
L b i ti
Lubrication only
l att the
th side
id wall
ll side:
id
 Contact areas inside approx. 2-3mm wide.
 The lubrication shall be done directly before inserting the drive into the lower part of
housing by means of a brush (do not use too much grease)
 The already lubricated side wall will be delivered ex factory from SN 143631 on.

Drive Disassembly
Caution:
Th two
The t screws from
f the
th drive
d i and d th
the th
three S
Screws ffrom
the main PCB could easily be mixed up!
Both are Torx plus IP10 but
Drive screw = 8mm (long)  Main PCB = 6mm (long)
The lower housing could be damaged!!

43
Drive (locking) Disassembly
Older locking Newer locking

Drive (locking) Disassembly

44
Drive (Drive Head cable) Disassembly

Drive (Nut) Disassembly
Lead- trough

45
Drive (Possible failures) Disassembly
• Foil
F il cable
bl off d
drive
i h head
d (!) = bending
b di and/or
d/ cutting
tti off
ff
• strain gauge pressure sensor = overstress (>150N)
• ground line = see Main PCB

Main PCB Disassembly

Space Station
Power Supply
Accessory lead
LS
Battery pack Space Control
- battery cells 5 Kabel
S1
-battery
battery
management S2 S3
2 Kabel
Stepper
S23
S22
4 Kabel
motor
Flex lead
16-adrig
Flex lead 0,5mm Drive Head PCB
Piston Brake 5-wired Raster
S26a
S26b
-pressure sensor
Piston Brake 1mm -Piston plate sensor
Raster Main PCB
S25
motor -Claw sensor

S27
Piston Brake
sensor 2 Kabel
Claw
motor
S21
Flex lead
30-adrig
Agenda: green = PCB 1mm Raster
Flexkabel
orange= motor Keypad PCB 15-adrig Display-PCB
S20
yellow = connector - Keypad - Display

- Illumination - Illumination

46
Main PCB (specialties) Disassembly
• Linear Poti  Syringe size detection
• Drive-End switch  reset of drive stepper counter
• Drive ground connect.  EMC protection (electromagnetic comb.)
• Light barriers  Drive movement (incl. direction)
• Gold Cap  buffering RTC and piezzo buzzer
• Piezzo Buzzer  only for complete power breakdown
• Loud Speaker  all other alarm

Gold Cap
Light barriers
Piezzo

47

8.2.3 Demo phase C Disassembly
Drive head
Disassembly/assembly
of the drive head see
also service manual
page 3-24 and 3-43.

48
8.2.3 Demophase C Demontage
Old version of the claw

8.2.3 Demophase C Demontage
New version of the claw

49
Drive head (interior) Disassembly
New membrane already included from S/N > 51480


50

9. Assembly
91C
9.1 Caution
ti

51
9.1 Caution Assembly
9.1.1 Cable routing
9.1.2 Piston Brake
9.1.3 Inserting the drive
9.1.4 Housing

9.1.1 Cable routing (Not good) Caution

52
9.1.1 Cable routing (good!) Caution

9.1.1 Cable routing Caution

53
9.1.2 Piston Brake Caution
1.Set
1 Set the brake into housing
(certain angle!) and be
aware of the Poti nose
2. Turn the brake ccw
3. push it in main PCB

direction
4. check its move ability

9.1.3 Inserting the drive Caution
When inserting the drive into the lower housing be aware of the following:
End position switch

1. Side wall
2. Foil cable from drive head
3. Shielding
4. Light barriers
5. etc.

54
9.1.4 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

 LP lead is outside the LP housing frame and
 the LP soldering contacts are in their intended position
• All connectors are in their intended positions
• Two snap locking are closed (right and left)

9.1.4 Housing (Loudspeaker) Caution

55
9.1.4 Housing (Loudspeaker) Caution

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

56
10.1 In general Service Prog./Calib.
• O
One opportunity
t it to
t update
d t Perfusor-/Infusomat
P f /I f t Space
S is
i to
t perform
f a single
i l 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

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)

57
USB CAN Boxes
New Old New Old

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

58
10.2 With Service Plug Service Prog./Calib.
What is different with Service Plug?
• Operation alarms are mute (for servicing)
• All deactivated settings are accessible
• The syringe calibration template could now be chosen (only)

 for use with TSC list – testing the pressure values, etc.
• Syringe
S i ttype „template“
t l t “ has
h no automatic
t ti bolus
b l reduction
d ti
• Service mode identification
• Activation of battery maintenance possible

10.3 The Calibration Service Prog./Calib.
• Calibration via Service Program - HiBaSeD

(interface connection only RS232 – up to SW D!!)
• There are two opportunities of performing the calibration:
1. “New device” - complete new calibration

(will be used e.g. after exchange of main PCB or after specific SW updates)
2. “Modify” - adjustment of existing calibration

(standard for all devices which shall be recalibrated; User specific setting like
Modification data will be kept untouched)
• While calibrating the syringe diameter be sure to turn the syringe holder completely
clock wise (when asked)
 axial fixation sensor has to be opened

59
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)

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

60
10.4.1 Disposables Others in Service Prog.
Data flow:
1.
1 Read
R d ffrom d
device
i
2. Save to Disp. editor
Perfusor 3. Load from file
4. Save to device
Space
 

Service Disposable
Program editor

PC
valid up to SW „E“

10.4.1 Disposables Others in Service Prog.
Inside „Disposables“ you have the opportunity to create your own table of disposables,
adapted to your special needs/situation in your hospital!
1. Open „Disposables“
2. Read the existing syringe table „from Device“
3. „Save as“ to file
4. Open the „disposable editor“ inside „tools“
5. Modify the table and save with „Accept“
6. Leave the editor with „close“
7. Now load your table into Service Program with „load from file“
8. Make sure to have the right table by checking the inactive
syringes at the lower end of the table
9. Save your syringe table „to device“
10. Automatically the new table from the device is shown

61
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

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:

62
Claw type
Silver Green

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)

• Drive
• Sensor
• Display
• Keyboard

63
10.4.4 History Viewer Service Prog./Calib.
You can choose the History viewer in the star up window of the Service Program
Th Password
The P d to
t gett the
th complete
l t access to
t the
th History
Hi t viewer
i (incl.
(i l „Service
S i Edit
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!

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

64
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

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

65
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

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.

66
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 10.4.5 Clone Data - Upload)

Perfusor Space: SW Version Devices delivered from

688 C 03 0001 J l 2005
July
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 ……
688 J 03 0006
688 L ……03
Use the proper Service Software for your device software!!

67
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. “F” 4… RS 232 or CAN 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
8. “L” 8… RS 232 or CAN SpOS*1
*1 SpOS = Space OnlineSuite

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).

68
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.

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

69
After all steps are carried out, finally the pump should run thru a functional test
t verify
to if the
th correctt operation.
ti
Test the device:
• Switch on the device and watch the correctness of the “Self-Test”

• Insert a syringe and start the infusion.
• Give a bolus and check if every activities trigger the desired function ant the
pump
• Check in the Menu “Status”
Status of the pump if the software version of the pump is
the desired one (e.g. 688 J 03 0006)
If no error messages or alarm are coming up, the software update has been successful!

10.5 Software Update - Specialties Service Prog./Calib.
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”

70
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
g units
 Enhanced Piggiback
 Space Glucose Control (SGC)

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)

71
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

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

72
11. Checking
11.1 Checking after repair (see SM subtopic 3.12)
11.2 Performing the TSC

11.1 Checking after repair Checking
• see SM subtopic 3.12

73
11.2 Performing the TSC Checking
For the following procedure use the SM
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

Test Testadapter
adapter (SP)EL_Safety

74
Test adapter (SP)

Strain gauge = Pressure stage 1 = 9 – 16N

Pressure stage 3 = 25 – 33N
Alarm „pressure high“ = via Strain gauge
Motor power limitation = Pressure stage 1 = 11 – 28N

Alarm „drive blocked“ = via motor power limitation

75

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

76

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HC-XX-DE08 | Service Department

1.3 Checklist Special-/Calibration tools Preparation

 Torx plus screwdriver (IP10, IP8, IP6)

HC-XX-DE08 | Service Department

HC-XX-DE08 | Service Department

1.3 Checklist Special-/Calibration tools Preparation

HC-XX-DE08 | Service Department

HC-XX-DE08 | Service Department

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

Save and easy transport via new developed

• Up to 3 pumps can be stacked together

• Easy to handle release button

HC-XX-DE08 | Service Department

Pole Clamp (SP)

• Designed for fixing stand-alone

HC-XX-DE08 | Service Department

6.1 In general System Overview

The lever locks the handle

The lever releases the

HC-XX-DE08 | Service Department

Repair Kit Pole Clamp SP

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

New Pole clamp connector

Article number Kit (á 10 pcs.): 34774395

HC-XX-DE08 | Service Department

New Power Supply

HC-XX-DE08 | Service Department

6.1 In general System Overview

New Power Supply

HC-XX-DE08 | Service Department

Accessories: connection to staff-call system

The cable will be delivered without

8713232 Connection Lead

HC-XX-DE08 | Service Department

6.1 In general System Overview

HC-XX-DE08 | Service Department

The latest PCA key is made out of metal

HC-XX-DE08 | Service Department

6.1 In general System Overview

PCA-protection cap set:

• for Perfusor Space

• for a safe removal protection of

HC-XX-DE08 | Service Department

6.2.2 Bottom side

6.2.3 The Front