B. Braun Perfusor Space User manual

Service Manual
Perfusor® Space
Version 1.3 English
1.31.0

508990_E_Pub_date_1_Mar_2010.doc Spare parts manual 2 / 39 VORWORT Für einen Austausch an der Waschmaschine müssen Original- oder ursprüngliche Teile verwendet werden. Nach einem Serviceeingriff sämtliche Paneels im ursprünglichen Zustand absichern, und dies es Handbuch an einer sicheren Stelle für eventuelle Informationen aufbewahren. Falls Sie telefonieren oder schreiben betr effs Ihre Maschine, immer den Typ, das Modell und Seriennummer angeben. Typ, Modell und Seriennummer sind an dem Herstellschild angegeben, daß am Maschinenhinterpaneel angebracht ist. Der Hersteller behält sich das Recht vor, jederzeit und ohne irgendwelche vorherige Bekanntmachung Änderungen von Spezifikationen, in diesem Katalog angeführt, vorzunehmen. Sämtliche Angaben sind lediglich informativ. Nehmen Sie, bitte, zur Kenntnis, daß dieser Katalog lediglich allgemeine Informationen betrifft, da es nicht möglic h ist, eine komplette Übersicht aller Details über sämtliche Maschinen unserer Produktion anzuführen. Der Katalog ist für Maschinen mit einer Kapazität von 24kg (53Pfund) ab Herstellnummer 24T003900RE, 35kg (77Pfund) ab Herstellnummer 35T003218RE bestimmt. - Maschinenausführung mit Münzgerät, Kennzeichnung MINC, oder ohne Münzgerät - Heizung: Kennzeichnung elektrische, Dampf, Gas INHALT
INTRODUCCIÓN Para un recambio en la máquina deben usarse las piezas originales. Después de la intervención de servicio, hay que asegurar todos los paneles al estado primordial y poner este Manual a un cierto lugar para servirle de información eventual. Si usted telefonea o escribe con respecto a su máquina, sírvase siempre indicar el tipo, modelo y número de serie. El tipo, el modelo y el número de serie están indicados en el rótulo de fabricación que está colocado en el panel trasero de la máquina. El fabricante cuando quiera, sin previo aviso se reserva el derecho de modificar las especificaciones que están indicadas en este catálogo. Todos los datos son sólo informativos. Sírvase dar cuenta de que este catálogo se refiere sólo a las informaciones generales, porque es imposible indicar un sumario completo de todos los detalles sobre todas las máquinas de nuestra fabricación. El catálogo está destinado para las máquinas con la capacidad de

Perfusor® Space, 1.0 gb 0- 3
0
0-Table of Contents
Important Preliminary Remarks Service Work Page 0 - 5
Technical Safety Checks Page 0 - 5
Current Versions Page 0 - 5
Revision Service Page 0 - 5
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
Setting Off Page 0 - 7
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 International Page 0 - 11
Return of Spare Parts and Test Equipment Page 0 - 11
Safety Officer
(§ 30 MPG) Page 0 - 11
Translation Page 0 - 11
System Overview Description Page 1 - 1
System Overview Page 1 - 1
Physical Construction Page 1 - 2
Function Page 1 - 3
Unit Software Page 1 - 6
Service Program Page 1 - 7
Technical Data Page 1 - 12
Options Page 1 - 12
Accessories Page 1 - 12
Unit Diagnosis / Calibration General Page 2 - 1
Alarms and Error Codes Page 2 - 3
The Most Important Error Modes Page 2 - 8
Device Check Page 2 - 9
Calibration Page 2 - 14
Procedural Instructions for Calibration Page 2 - 14
Trouble Shooting Page 2 - 29
Disassembly / Assembly General Page 3 - 1
Battery Module Page 3 - 9
Unit Foot Page 3 - 11
Operating Unit Page 3 - 12
Upper Part of Housing Page 3 - 17
Release Button Page 3 - 19
Loudspeaker Page 3 - 19
Drive Page 3 - 20
Syringe Holder with Piston Brake Page 3 - 27
Processor PCB Page 3 - 34
Assembly / Installation Page 3 - 35
Checks after Repair Page 3 - 47
1.01.0

Table of Contents
0
0- 4 Perfusor® Space, 1.0 gb
Servicing the Unit Cleaning Page 4 - 1
Servicing the Battery Page 4 - 1
Technical Safety Check (TSC) Perfusor® Space 1
Technical Safety Check (TSC) Power Supply SP 1
Procedural Instructions on the TSC Visual Inspection Page 7 - 1
Electrical Safety
according to IEC/EN 60601-1
or VDE 0750 and VDE 0751 Page 7 - 2
Functional Inspection Perfusor® Space Page 7 - 3
Functional Inspection Power Supply SP Page 7 - 6
Test Equipment and Special Tools Test equipment Page 8 - 1
Special Tools Page 8 - 3
Spare Parts List Page 9 - 1
Revision Documentation Description of Version Page 10 - 1
Version List of the Individual Pages Page 10 - 1
Index Page 11 - 1
1.01.0

Perfusor® Space, 1.1 gb 0- 5
0
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 medial 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
periods 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
observed
- 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
modifications. The state of the revision is indicated by the index
number in the footer of every page.
Revision Service The possession of this manual does not automatically mean
inclusion in the revision service. You will be included in the
revision service after:
- technical training by B. Braun Melsungen or
- a written order placed with the sales department of B. Braun
(fee required).
1.11.0

Important Preliminary Remarks
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0- 6 Perfusor® Space, 1.1 gb
Responsibility of the Manufacturer The manufacturer, person who assembles, installs or imports the
device can only be held responsible for safety, reliability and
performance 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
intervals,
- 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
service.
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
instructions 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.
Especially 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.
1.11.0

Important Preliminary Remarks 0
Perfusor® Space, 1.1 gb 0- 7
Each workstation must be equipped according to the
recommendations with the necessary static protective measures,
if ESD components or boards are handled.
Each workstation must be equipped with a conductive table
surface. 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
completely. The spare parts required are listed in the repair
descriptions.
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.
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.
Fig.: 0 - 1
1.1

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 .
1.11.0

Important Preliminary Remarks 0
Perfusor® Space, 1.2 gb 0- 9
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)
CS Calibration Step
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)
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
TS Troubleshooting Step
TSC Technical Safety Checks
1.2

Important Preliminary Remarks
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1.21.0
UTS Unit Test Step
VDE Verband der Elektrotechnik,
Elektronik und
Informationstechnik e.V.
(German electrical engineering
association)

Perfusor® Space, 1.3 gb 0- 11
0
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)
Nadja Machal
Fax: +49 5661 / 75 - 47 89
e-mail: [email protected]
Service Hotline International Karl Tippel, Tanja Kördel
Fax: +49 5661 / 71 - 35 26
e-mail: [email protected]
e-mail: [email protected]
Return of Spare Parts and Test Equipment B. Braun Melsungen AG
Schwarzenberger Weg 73-79
Wareneingang Werk C
34 212 Melsungen
Germany
Safety Officer
(§ 30 MPG)
Dr. Ludwig Schütz
e-mail: [email protected]
Translation Cs2 Informatik GmbH & Co. KG, Germany
1.3

Contact Persons
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0- 12 Perfusor® Space, 1.0 gb
For your notes:
1.0

Perfusor® Space, 1.0 gb 1- 1
1
1-System Overview
Description The Perfusor® Space (PSP) is according to IEC/EN 60601 resp. IEC/
EN 60601-2-24 a transportable infusion syringe pump for
administrating fluids in the nutritional therapy and infusion
technique as well as for home care applications.
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
technology 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
Infusomat® Space P, as well as the other devices of the system are
of modular design. Up to three pumps can be connected together
mechanically using L rails on the bottom of the unit and grooves
on the top. They can then be fastened to a drip stand or
appropriate rail using the pole clamp.
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.
Up to six SpaceStations can be set-up as a column with a total of
24 pumps. SpaceStation placed next to each other can be
connected 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
loudspeaker in the SpaceCover Comfort.
Fig.: 1 - 1 Space system
Legend of fig. 1 - 1:
ItemDesignation
1 SpaceCover
2 Infusion pump Infusomat® Space
3 Infusion syringe pump Perfusor® Space
4 SpaceControl
5 SpaceStation
1
2
3
4
5
1.0

System Overview
1
1- 2 Perfusor® Space, 1.0 gb
Physical Construction
Fig.: 1 - 2 Perfusor® Space
Legend of fig. 1 - 2:
ItemDesignation
1 Perfusor® Space
2 Drive head
3 Syringe holder with piston brake
4OperatingUnit
5 Syringe area
6 Connector “P2“ for SpaceStation module, external 12 V DC
and accessories
7 Connector “P3“, connection to SpaceControl module
8 Battery compartment cover
1
4
2
3
6
78
5
1.0

System Overview 1
Perfusor® Space, 1.0 gb 1- 3
The Perfusor® Space housing mainly consists of the bottom part
and the upper part.
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 with
two hinges. This operating unit covers the area for the syringes.
The complete drive assembly, consisting of lead screw and drive
head with driving tube is located directly behind the syringe area
in the bottom part of the housing. The housing bushing for the
driving tube is located in the side of the housing.
The syringe holder is mounted in the right side of the housing
bottom part.
The processor PCB with the permanently connected external
connectors “P2” and “P3” is located at the bottom of the housing
bottom part.
Function There are two power options for the Perfusor® 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
ambulance 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 Perfusor® Space is connected to a SpaceControl by connector
“P3”.
The function processor controls all the functions of the Perfusor®
Space. Data is stored in a non-volatile memory which also
controls the external data transfer.
The control microprocessor monitors all important responses of
the function processor to incoming information. If a response
does not correspond with that expected by the control
microprocessor, an error message is generated and the device is
switched to a safe stop state.
The drive motor is monitored by a detector for speed and direction
of rotation. The extended end position of the drive head is
detected by a switch on the processor PCB.
1.0

System Overview
1
1- 4 Perfusor® Space, 1.0 gb
The pressure in the infusion system is measured through a strain
gauge measuring in the drive head and monitored in the device
electronics. The data from the strain gauge is continuously
compared with the limit values which are calculated dependent
on the selected syringe type and the pressure settings. When the
limit values are exceeded an alarm is automatically triggered and
the pressure in the infusion system is reduced. The maximum
pressure is additionally limited by a second, independent system.
This maximum pressure limitation is performed using the motor
current control.
The syringe size detection is performed via the syringe holder. The
syringe holder is connected to a potentiometer. The syringe size is
determined from the resistance of the potentiometer.
The syringe is fixed with the syringe holder and the axial fastening
device. The syringe piston is fastened with two claws in the drive
head. When a syringe is inserted the syringe piston is held by the
piston brake, until the piston has been caught by the claws.
Keyboard and display as well as the syringe area are illuminated.
1.0

System Overview 1
Perfusor® Space, 1.0 gb 1- 5
Fig.: 1 - 3 Block diagram Perfusor® Space
1.0

System Overview
1
1- 6 Perfusor® Space, 1.0 gb
Unit Software Approved Software Versions
688A030032
- Basic software
688A030035
- Improved functions
688A030040
- Improved functions
- Languages French and Swedish added
688B030002
- Improved functions
688B030003
- CAN bus functioning
688C030001
- Dose calculation
- Changed CAN log
688D030001
- Drug list data base
- Changed user language
688E030003
- Improved functions
- Piggyback
- Soft limits
688F030006
-PCA
- Changed claw configuration
- Optimized alarm handling
688G030002
- Improved functions
Fig.: 1 - 4
Position 12345678910
Digit 688C030001
Revision level
Hardware
Software group
Device type: Perfusor® Space
1.0

System Overview 1
Perfusor® Space, 1.0 gb 1- 7
1.0
Software Update of the Unit
The instructions for updating the software are supplied with the
software itself.
CAUTION
If the device is disconnected while the software is being updated
or the device or PC is switched off, a component of the software
may be seriously damaged so that repairs are no longer possible.
In such a case the software cannot be updated via the PC and the
device must be returned to B. Braun.
Service Program Approved Version
Note
Please note that text and / or functions of the Service Program
may change depending on the software version. The following
screen illustrations are only examples and represent the state
when the manual was printed.
- 0.0.28
- 1.0.0
- 1.1.2
- 1.1.3
- 1.1.4
- 1.2.1
- 1.3.5
- 1.5.0
- 2.0.1
- 3.1.0
- 4.0.0
- 5.1.0
Starting the Service Program
Note
Installation and further operation of the Service Program is
described in its separate instructions for use.

System Overview
1
1- 8 Perfusor® Space, 1.0 gb
1.0
1. Start the “HiBaSeD.exe” program (History, Barcode, Service,
Drug list) on the PC. The Service Program is loaded and
started and the initial window of the Service Program is
displayed.
2. Read the notes carefully.
3. Mark the field “I accept all conditions” and then the field
“Yes” to confirm that you have read the notes.
Note
Click the field “English” to switch the language of the notes over
to English.
4. Enter the password and confirm it by clicking the field “Start”.
The Service Program checks the PC interfaces for connected
devices of the Space system. Units that were found are
displayed for a short moment on the screen.
Fig.: 1 - 5
Fig.: 1 - 6
Fig.: 1 - 7