Braun Infusomat Space User manual

Infusomat® Space
Service Manual
Version 6.0 English
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0 - RX only

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This Service Manual is valid for Designation Part No.
Infusion Pump Infusomat® Space . . . . . . . . . . . . . . . . . 0871 3050
Infusion Pump Infusomat® Space (USA). . . . . . . . . . 0871 3050U
Infusion Pump Infusomat® Space (USA). . . . . . . . . . . 0871 3051U
Infusion Pump Infusomat® Space (USA). . . . . . . . . . 0871 3052U
Infusion Pump Infusomat® Space (Canada) . . . . . . . . 0871 3050C
Infusion Pump Infusomat® Space (China) . . . . . . . 0871 3050CN
This Service Manual is available under
the following part number:
Designation Part No.
Service Manual Infusomat® Space, English . . . . . . . . . 8713 9120
Languages of this Manual The Service Manual for this unit can be supplied in the following
languages:
Designation Part No.
Service Manual Infusomat® Space, German . . . . . . . . .8713 9110
The complete Service Manual contains
the following pages:
Page 0-1 to Page 0-12
Page 1-1 to Page 1-18
Page 2-1 to Page 2-16
Page 3-1 to Page 3-58
Page 4-1 to Page 4-4
Page 5-1 to Page 5-4
Page 6-1 to Page 6-10
Page 7-1 to Page 7-2
Page 8-1 to Page 8-6
Page 9-1 to Page 9-2
Page 10-1 to Page 10-2

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Infusomat® Space 6.0 0 - 3EN
0 - Table of Contents
Important Preliminary Remarks Service Work Page 0 - 5
Technical Safety Checks Page 0 - 5
Current Versions Page 0 - 5
Product availability Page 0 - 5
Responsibility of the Manufacturer Page 0 - 6
Quality Management Page 0 - 6
Checks and Repair Page 0 - 6
Notes on ESD Page 0 - 6
Spare Parts and Test Equipment Page 0 - 7
Safety data sheets Page 0 - 7
Setting Off Page 0 - 7
Special PDF functions Page 0 - 8
List of Abbreviations Page 0 - 9
Contact Persons Technical Training Page 0 - 11
Entry for Technical Training Page 0 - 11
Ordering of Spare Parts and Test Equipment Page 0 - 11
Service Hotline Page 0 - 11
Returns Page 0 - 11
Safety Officer
(§ 30 MPG) Page 0 - 11
System Overview Description Page 1 - 1
System Overview Page 1 - 1
Physical Construction Page 1 - 2
Function Page 1 - 4
Unit Software Page 1 - 9
Service Program Page 1 - 10
Technical Data Page 1 - 16
Options Page 1 - 16
Accessories Page 1 - 16
Functional test acc. to §5, Section 1, MPBetreibV (German
Medical Devices Operator Ordinance) Page 1 - 17
Unit Diagnosis / Calibration Alarms and Error Codes Page 2 - 1
CAN error states Page 2 - 7
The Most Important Error Modes Page 2 - 10
Calibration Page 2 - 10
Disassembly / Assembly General Page 3 - 1
Slide Guide Page 3 - 9
Cover for Drop Sensor Connector Page 3 - 10
Emergency Release Plug Page 3 - 10
Unit Foot Page 3 - 11
Battery Module Page 3 - 12
Housing Upper Part Page 3 - 19
Housing Bottom Part Page 3 - 22
Inner Frame and Housing Front Panel Page 3 - 23
Inner frame Page 3 - 25
Housing Front Panel Page 3 - 29
Operating Unit Page 3 - 31

Table of Contents
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Processor PCB Page 3 - 37
Installation / Assembly Page 3 - 40
Pole Clamp SP Adapter Kit Page 3 - 54
Checks after Repair Page 3 - 55
Servicing the Unit Cleaning and Disinfecting Page 4 - 1
Servicing the Battery Page 4 - 3
Technical Safety Check (TSC) Infusomat® Space Page 5 - 1
Power Supply SP Page 5 - 4
Procedural Instructions on the TSC Visual Inspection Page 6 - 1
Electrical Safety
According to IEC 60601-1 or IEC 62353 Page 6 - 2
Functional Inspection Infusomat® Space Page 6 - 3
Functional Inspection Power Supply SP Page 6 - 10
Test Equipment and Special Tools Test equipment Page 7 - 1
Special Tools Page 7 - 2
Spare Parts List Page 8 - 1
Revision Documentation Description of Version Page 9 - 1
Index Page 10 - 1

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Infusomat® Space 6.0 0 - 5EN
0 - Important Preliminary Remarks
Service Work The present manual is for your information only. The possession of
this manual does not authorize the performance of service work.
Service tasks may only be executed by persons, who
- have received appropriate training on the system from
B. Braun
- are included in the revision service
- possess the necessary test equipment and mechanical aids,
and
- fulfill the personal requirements (training and knowledge).
Technical Safety Checks The user is obliged to perform or to have performed the Technical
Safety Checks on those medical products for which these checks
have been prescribed by the manufacturer and to carry them out
according to the indications of the manufacturer as well as the
generally approved technical standards while adhering to the pe-
riods stated (§ 6 MP BetreibV).
B. Braun also recommends training on the Technical Safety
Checks, or to perform at least the steps indicated in the current
version of the manual, as:
- the TSC requires that the instructions in the manuals are ob-
served
- the manuals are a reference for measurements
- depending on the unit type, the Service Program must be
called which may lead to a dangerous unit condition in case
of inappropriate operation. Furthermore, a special service
connector may be necessary.
Current Versions This manual version corresponds to the state when the manual
was written. B Braun reserves the right to make technical modifi-
cations. The state of the revision is indicated by the index number
in the footer of every page.
To view the current Service Manual, please visit the Service Portal
at: https://extranet.bbraun.com.
Approval to use the service portal will only be granted after com-
pletion of a technical training course..
Product availability Not all software versions, hardware, or spare parts are available in
all regions. Please consult your local B. Braun representative for
availability.

Important Preliminary Remarks
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Responsibility of the Manufacturer The manufacturer, person who assembles, installs or imports the
device can only be held responsible for safety, reliability and per-
formance if
- mounting, enhancements, new settings, changes or repairs
are carried out by duly authorized persons,
- the electrical installation in the corresponding room meets
the requirements of the VDE 0107, VDE 0100 part 710 or
IEC 60364-7-710 and the national standards,
- the device is used in accordance with the instructions for use
and the Service Manual,
- the Technical Safety Checks are performed at regular inter-
vals in the case of devices for which TSC checks are manda-
tory,
- a current manual which corresponds to the revision state is
used when carrying out maintenance, repair and service,
- the service technician takes part in the revision service,
- the technician has participated in a technical training course
for the specific B. Braun unit.
Quality Management B. Braun is certified in accordance with DIN EN ISO 9001 and
ISO 13485. This certification also includes maintenance and serv-
ice.
The unit has the CE label. The CE label confirms that the device
corresponds to the “Directive of the Council for Medical Products
93/42/EC” of June 14, 1993.
Checks and Repair Training may only be performed by B. Braun. The possession of the
manual does not authorize the performance of repairs. The in-
structions on electrostatic sensitive components (ESD standards)
must be observed.
After repair a device check or diagnosis is to be carried out.
Notes on ESD Semiconductors can be destroyed by electrostatic discharge. Es-
pecially MOS components can be damaged by interference from
electrostatic fields, even without discharge via contact. This type
of damage is not immediately recognizable. Unit malfunctions
can even occur after a longer period of operation.

Important Preliminary Remarks
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Infusomat® Space 6.0 0 - 7EN
Each workstation must be equipped according to the recommen-
dations with the necessary static protective measures, if ESD
components or boards are handled.
Each workstation must be equipped with a conductive table sur-
face. The conductive surface, the soldering iron or the soldering
stations must be grounded via protective resistors.
Chairs must be of antistatic design. The floor or floor mats should
be of electrically conductive material.
Personnel must wear conductive wristbands which are connected
to a central ground potential via protective resistors, e.g. the
ground contact of a wall outlet. Furthermore it is recommended
that personnel wear cotton clothing and electrically conductive
shoes to prevent electrostatic charge.
Spare Parts and Test Equipment Only use original spare parts from the manufacturer. Do not
tamper with assembly groups which can only be exchanged com-
pletely. The spare parts required are listed in the repair descrip-
tions.
When assembling spare parts with a serial or batch number (see
label on the packaging or number plate) the serial number of the
affected medical device has to be documented.
Service personnel are responsible for the calibration of their test
equipment. Original test equipment can be calibrated at the
works of B. Braun. Further information is available upon request.
Safety data sheets You can request the material safety data sheets for the consum-
ables described in this Service Manual free of charge from
B. Braun. You can download the latest version of each document
as a PDF in the service portal under https://extranet.bbraun.com.
Setting Off Additional notes and warnings are set off as follows:
Note
Is used for additional or special notes concerning information and
working steps.
CAUTION
Is used for working steps which may result in damage to the unit,
system or to a connected device.
WARNING
!
Is used for working steps which may result in personal injury.
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Important Preliminary Remarks
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References to chapters are shown as follows
(see „Setting Off“ ➨pg. 0 - 7)
References to figures and tables are shown as follows
Fig.: 2 - 3 or Table 2 - 1
References to item numbers in figures are shown as follows
(Fig.: 1 - 1 / Item 1)
In this case “Fig.: 1 - 1“ is the figure number and “Item 1“ the item
number within the figure.
When the Service Manual is stored as pdf-file, these references
are displayed green. Click with the mouse button on a reference
to jump to the corresponding source.
Menu commands are described as:
Menu
File .
Special PDF functions In the PDF format of this manual, special functionality is integrat-
ed, which can be used with Adobe® Reader®:
- Form function
For completing, saving, and printing the TSC on a PC, laptop,
etc.
Software requirements
- Adobe® Reader® Version XI or higher is installed.
Form function
Forms included in the manual, which are to be filled out by the
reader, each show an "Edit" button at the top of the first page
(Fig.: 0 - 2). The list can be completed and printed online or saved
locally as a PDF:
1. Click the "Edit" button.
The form is opened in a separate PDF file.
2. If you want to save the form as a PDF, you can save an empty
copy of the form locally with
File > Save As and open this for
editing.
3. The following form field functions are available:
- Entry of text and figures in the form fields with the key-
board.
- Checking test steps by clicking the check boxes (click
again to clear).
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Important Preliminary Remarks
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Infusomat® Space 6.0 0 - 9EN
- Deletion of non-applicable test steps by marking the en-
try with the mouse and selecting “Strikethrough Text” in
the shortcut menu (right mouse key; only for editing in
the local form copy).
- Printing the completed form with
File > Print and then
selecting a connected printer.
- Saving the completed form as a PDF with
File > Save .
4. To end the form, close the PDF file.
Note
After the PDF file has been closed, the entered data are only saved
if you were working in the local copy. This can be opened at any
time to continue editing.
List of Abbreviations Abbreviations which are not generally known, but are used in this
manual, are listed below.
CAN Controller Area Network
CE Communauté Européenne
(European Communities)
DIN Deutsche Industrie Norm
(German Industrial Standard)
EN European Standard
ESD Electrostatic Discharge
FuP Function Microprocessor
IEC International Electrotechnical
Commission
ISO International Standardization
Organization
ISP Infusomat® Space
ISPS Infusomat® Space, Silicon
ISPP Infusomat® Space, PVC
KuP Monitoring Microprocessor
LCD Liquid Crystal Display
MOS Short for the following
company name:
MOS Technology, Inc.
(Commodore Semiconductor
Group)

Important Preliminary Remarks
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PCA Patient-Controlled Analgesia
PSP Perfusor® Space
SP Space (System)
SPC SpaceCover
SPCC SpaceCover comfort
SPCS SpaceCover standard
SPCO SpaceCom
SPCT SpaceControl
SPS SpaceStation
TEMP Temperature
TSC Technical Safety Checks
VDE Verband der Elektrotechnik,
Elektronik und
Informationstechnik e.V.
(German electrical engineering
association)

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Infusomat® Space 6.0 0 - 11EN
0 - Contact Persons
Technical Training Via local representative.
Entry for Technical Training Application for a technical training course must be made via the
responsible representative.
Ordering of Spare Parts and Test Equipment Please contact your local B. Braun subsidary.
International Technicians (Intercompany)
e-mail: Spare-P[email protected]
Service Hotline Service Hotline International (without U.S. and Canada)
e-Mail: [email protected]
Service Hotline U.S. and Canada
Phone: [phone]-PUMP
Phone: [phone]
Returns Return of spare parts, test equipment, and units for repairs:
B. Braun Melsungen AG
Schwarzenberger Weg 73-79
Wareneingang Werk C
34 212 Melsungen
Germany
U.S. and Canada Returns:
B. Braun Medical Inc.
1601 Wallace Drive, Suite 150
Carrollton, TX 75006
USA
Safety Officer
(§ 30 MPG)
Dr. Ludwig Schütz
e-mail: [email protected]
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Contact Persons
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For your notes:

1
Infusomat® Space 6.0 1 - 1EN
1 - System Overview
Description The Infusomat® Space (ISPS) is according to IEC/EN 60601-1 or
IEC/EN 60601-2-24 a portable volumetric infusion pump for infu-
sion of small to high volumes with ultimate precision and is suit-
able for intravenous applications, blood transfusion and enteral
nutrition.
The medical specialist must decide on suitability for application
on the basis of the warranted properties and the technical data.
System Overview The Space system is a modular design of modern infusion technol-
ogy for stationary, mobile or private use. The key modules and
their connection to the peripheral devices are shown in Fig.: 1 - 1.
All the pump types, Perfusor® Space, Infusomat® Space and Infu-
somat® Space P, as well as the other devices of the system are of
modular design. Up to three pumps can be connected together us-
ing L rails on the bottom of the unit and grooves on the top. The
pumps can be connected to each other and to an external power
supply via a connection cable.
The SpaceControl module can be used to extend operation. One
single pump can be inserted onto this module. The pump is then
connected via connectors to the module.
The SpaceStation module allows the set-up of a complete pump
system with up to 24 pumps. Up to four pumps can be installed in
every SpaceStation. The pumps are supplied with power via the
integrated power supply and the built-in connectors. The pumps
are connected to the optional SpaceCom via these connectors.
SpaceControl can also be integrated into the system via the con-
nected pump and from there via the connector.
Up to 6 SpaceStations can be set-up as a column with a total of
24 pumps. SpaceStation placed next to each other can be con-
nected via special connection cables, if the maximum number of
24 pumps in maximum three columns is not exceeded.
SpaceCover Standard or SpaceCover Comfort forms the top of
each column. Alarms are signalled by a row of LEDs and a loud-
speaker in the SpaceCover Comfort.
Fig.: 1 - 1 Space system
Legend of fig. 1 - 1:
Item Designation
1 SpaceCover
2 Infusion pump Infusomat® Space
3 Infusion syringe pump Perfusor® Space
4 SpaceControl
5 SpaceStation
1
2
3
4
5
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System Overview
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Physical Construction The Infusomat® Space housing mainly consists of the bottom part,
the upper part, the front part and the operating device.
The battery module is inserted in the rear of the housing upper
part. The opening is covered by the battery compartment cover.
The operating unit is attached to the front of the bottom part. The
thrust bearing of the tube pump (peristaltic pump), the spring-
mounted pressure elements for the two pressure sensors and the
air inline sensor as well as the shackle for the slide clamp of the
Infusomat® Space Line are located at the rear of the operating
unit. The operating unit is mechanically locked in its closed posi-
tion via three metal pins. A motor-driven lock bolt is used to lock
the operating unit. In case of an emergency, the operating unit
can be opened through an opening on the left side of the housing
top. During normal operation this opening is closed with a plug.
According to the line run the following subsystems are installed
in the housing front panel, from right to left:
- Pressure sensor (upstream, container-side)
- Slide guide with 12 slides (mechanically coded, can be dis-
mantled without tool)
Coding for ISPS: top left
Coding for ISPP: middle right
- Air inline sensor
- Pressure sensor (downstream, patient-side)
- Safety clamp (ISPS).
The slides are moved in the slide guide by pump connecting rods.
The connecting rods are mounted on an eccentric shaft and are
led outside through a seal diaphragm. The complete pump is flex-
ibly mounted in the inner frame of the device and is moved in
combination with the lock bolt. The lock bolt drive of the pump is
also installed in the inner frame.
The processor PCB with the external connectors “P2” and “P3” is
located at the bottom of the housing bottom part.

System Overview
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Infusomat® Space 6.0 1 - 3EN
Fig.: 1 - 2 Infusomat® Space
Legend of fig. 1 - 2:
Item Designation
1 Infusomat® Space
2 Operating unit
3 Cover for drop sensor connector
4 Connector “P2“ for SpaceStation module, external 12 V DC
and accessories
5 Connector “P3“, connection to SpaceControl module
6 Battery compartment cover
1
2
4
56
3

System Overview
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1 - 4 Infusomat® Space 6.0 EN
Function There are two power options for the Infusomat® Space:
- Via the inserted battery module
- Via an external 12 V DC power supply (e.g. SpaceStation,
SpaceControl, an external power supply or from an ambu-
lance car) connected to connector “P2”
The voltage supplied is converted to the internal voltages required
through a voltage transforming and monitoring circuit on the
processor PCB.
An independent circuit in the battery module monitors the battery
cells and controls their charge condition.
The keyboard and the display are lighted.
The Infusomat® Space is connected to a SpaceControl by connec-
tor “P3”.
The function processor controls all the functions of the Infuso-
mat® Space. Data is stored in a non-volatile memory which also
controls the external data transfer.
The monitoring processor monitors all important responses of the
function processor to incoming information. If a response does
not correspond with that expected by the monitoring processor,
an error message is generated and the device is switched to a safe
stop state.
The Infusomat® Space Line and its contents is monitored by the
sensors listed below:
- Optional drop sensor
- Pressure sensor upstream (container-side)
Monitors the upstream pressure (negative pressure)
- Air inline sensor
Monitors the line contents (liquid - air)
- Temperature sensor
Monitors the temperature of the medium in the line (inte-
grated in the air inline sensor)
- Pressure sensor downstream (patient-side)
Monitors the downstream pressure (overpressure)
The pump drive motor is monitored by a speed and direction of ro-
tation detection function.
The motor of the lock bolt drive is controlled via the processor
PCB. The different positions of the lock bolt during operation are
monitored by a linear potentiometer.

System Overview
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Infusomat® Space 6.0 1 - 5EN
The safety clamp squeezes the Infusomat® Space Line when the
operating unit is opened or internal calibration is carried out to
protect the patient and prevent an uncontrolled drug flow to the
patient. Beside the position monitoring via the lock bolt, the
“open/closed” state of the safety clamp is monitored by a light
barrier. The safety clamp is closed and the Infusomat® Space Line
is squeezed mechanically when the slide clamp of the Infusomat®
Space Line is inserted. When the operating unit is opened the slide
clamp is pulled out of the safety clamp until the Infusomat®
Space Line is pinched. The safety clamp is only opened by manual
operation of the safety clamp lever and the Infusomat® Space
Line can be removed.
To ensure patient safety the operating unit is automatically
locked. For this purpose, the operating unit is manually pressed in
the lock bolt with the three locking pins. The resistance of the lin-
ear potentiometer which is monitored by the controller is
changed when the position of the lock bolt changes. Locking is
started and can take up to 10 seconds. During locking, several cal-
ibrations are carried out automatically, for example:
-occlusiontest
To check, for example, the function of the safety clamp
- pressure calibration of the two pressure sensors.
The operating unit is also unlocked automatically via the lock bolt.
In case of a power failure or malfunction, the operating unit can
be unlocked manually by a small emergency release crank. To do
this, the lock bolt is moved manually with the crank to the open
position, as described below.

System Overview
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1 - 6 Infusomat® Space 6.0 EN
Opening the Operating Unit Manually
1. Press the locking of the battery compartment cover using a
pointed tool and remove the battery compartment cover from
the housing.
2. Remove the emergency release crank out of the battery com-
partment cover.
3. Press the emergency release crank carefully in the emergency
release plug on the left side of the housing until stop.
Note
The hexagon socket of the emergency release plug is tapered to
the inside. If the emergency release crank is not inserted until
stop, the hexagon socket may be damaged.
Fig.: 1 - 3
Fig.: 1 - 4

System Overview
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Infusomat® Space 6.0 1 - 7EN
4. Turn the emergency release plug carefully with the emergen-
cy release crank through 90° to the right (clockwise in arrow
direction) until stop and remove the plug out of the housing.
5. Insert the emergency release crank in the housing opening.
The crank must be pushed in the hexagon socket of the lock
bolt drive.
CAUTION
Do not turn the emergency release crank past the stop as this may
damage the housing.
6. Turn the emergency release crank to the right (clockwise ac-
cording to arrow direction) until the operating unit is re-
leased and opens.
Fig.: 1 - 5
Fig.: 1 - 6

System Overview
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1 - 8 Infusomat® Space 6.0 EN
Fig.: 1 - 7 Block Diagram Infusomat® Space