Service Manual
128 Pages
Preview
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Perfusor® Space Service Manual
Version 1.1 english
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This Service Manual is valid for:
Designation
Part No.
Infusion syringe pump Perfusor® Space... 0871 3030
This Service Manual is available under the following part number:
Designation
Part No.
Languages of this Manual
The Service Manual for this unit can be supplied in the following languages:
Service Manual Perfusor® Space, english... 8713 9020
Designation
Part No.
Service Manual Perfusor® Space, german... 8713 9010 Service Manual Perfusor® Space, french... 8713 9030
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Table of Contents
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Important Preliminary Remarks
Service Work Technical Safety Checks Current Versions Revision Service Responsibility of the Manufacturer Quality Management Checks and Repair Notes on ESD Spare Parts and Test Equipment Setting Off List of Abbreviations
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0-5 0-5 0-5 0-5 0-6 0-6 0-6 0-6 0-7 0-7 0-9
Contact Persons
Technical Training Entry for Technical Training Ordering of Spare Parts and Test Equipment Service Hotline Return of Spare Parts and Test Equipment Safety Officer (§ 30 MPG) Translation
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0 - 11 0 - 11 0 - 11 0 - 11 0 - 11
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System Overview
Description System Overview Physical Construction Function Unit Software Service Program Technical Data Options Accessories
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1-1 1-1 1-2 1-3 1-6 1-7 1 - 12 1 - 12 1 - 12
Unit Diagnosis / Calibration
General Alarms and Error Codes The Most Important Error Modes Device Check Calibration Procedural Instructions for Calibration Trouble Shooting
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2-1 2-3 2-8 2-9 2 - 13 2 - 14 2 - 25
Disassembly / Assembly
General Battery Module Unit Foot Operating Unit Upper Part of Housing Release Button Loudspeaker Drive Syringe Holder with Piston Brake Processor PCB Assembly / Installation Checks after Repair
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3-1 3-9 3 - 11 3 - 12 3 - 17 3 - 19 3 - 19 3 - 20 3 - 27 3 - 34 3 - 35 3 - 47
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Table of Contents
Servicing the Unit
Cleaning Servicing the Battery
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Technical Safety Check (TSC)
Perfusor® Space
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Technical Safety Check (TSC)
Power Supply SP
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Procedural Instructions on the TSC
Visual Inspection Electrical Safety according to IEC/EN 60601-1 or VDE 0750 and VDE 0751 Functional Inspection Perfusor® Space Functional Inspection Power Supply SP
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7-2 7-3 7-5
Test Equipment Special Tools
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8-1 8-3
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Test Equipment and Special Tools
Spare Parts List Revision Documentation
Index
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Description of Version Version List of the Individual Pages
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Service Work
Technical Safety Checks
Important Preliminary Remarks
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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
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are included in the revision service
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possess the necessary test equipment and mechanical aids, and
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fulfill the personal requirements (training and knowledge).
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 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
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the manuals are a reference for measurements
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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:
Perfusor® Space, 1.1 gb
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technical training by B. Braun Melsungen or
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a written order placed with the sales department of B. Braun (fee required).
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Responsibility of the Manufacturer
Quality Management
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,
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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,
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the device is used in accordance with the instructions for use and the Service Manual,
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the Technical Safety Checks are performed at regular intervals,
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a current manual which corresponds to the revision state is used when carrying out maintenance, repair and service,
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the service technician takes part in the revision service,
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the technician has participated in a technical training course for the specific B. Braun unit.
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
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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.
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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.
Fig.: 0 - 1 Spare Parts and Test Equipment
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.
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 Section 9. 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. References to chapters are shown as follows (see “Setting Off“ ➨ pg. 0 - 8) References to figures and tables are shown as follows Fig.: 2 - 3 or Table 2 - 1
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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.
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List of Abbreviations
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Abbreviations which are not generally known, but are used in this manual, are listed below. CAN
Controller Area Network
ESD
Electrostatic Discharge
TS
Trouble Shooting
FuP
Function Microprocessor
UTS
Unit Test Step
ISP
Infusomat® Space
ISPS
Infusomat® Space, Silicon
ISPP
Infusomat® Space, PVC
CS
Calibration Step
KuP
Control Microprocessor
LCD
Liquid Crystal Display
PCA
Patient Controlled Analgesia
PSP
Perfusor® Space
SP
Space (System)
SPC
SpaceCover
SPCC
SpaceCover comfort
SPCS
SpaceCover standard
SPCO
SpaceCom
SPCT
SpaceControl
SPS
SpaceStation
TSC
Technical Safety Check
TEMP
Temperature
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For your notes:
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Contact Persons
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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
Karl Tippel, Tanja Kördel Phone: +49 5661 / 71 - 35 25 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. Dirk Woitaschek e-mail: [email protected]
Translation
PAS GmbH, Brückner GmbH, Germany
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For your notes:
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Description
System Overview
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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.
1 2
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.
3
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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
Perfusor® Space, 1.1 gb
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.
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System Overview
Physical Construction 1
2
5
4
3
6 8
7
Fig.: 1 - 2 Perfusor® Space Legend of fig. 1 - 2: ItemDesignation 6
Connector “P2“ for SpaceStation module, external 12 V DC and accessories
Syringe holder with piston brake
7
Connector “P3“, connection to SpaceControl module
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Operating unit
8
Battery compartment cover
5
Syringe area
1
Perfusor® Space
2
Drive head
3
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System Overview
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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 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
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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. The pressure in the infusion system is measured through a strain gauge measuring in the drive head and monitored in the device
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System Overview
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. In addition the maximum possible pressure is limited via a second independent system which monitors motor current. 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.
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System Overview
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Fig.: 1 - 3 Block diagram Perfusor® Space
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System Overview
Unit Software
Approved Software Versions 688A030032
Position
1 2 3 4 5 6 7 8 9 10
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Digit
6 8 8 C 0 3 0 0 0 1
688A030035 -
Revision level
Improved functions
688A030040
Hardware
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Improved functions
Software group
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Languages French and Swedish added
Device type: Perfusor® Space Fig.: 1 - 4
Basic software
688B030002 -
Improved functions
688B030003 -
CAN bus functioning
688C030001 -
Dose calculation
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Changed CAN log
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.
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System Overview
Service Program
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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. -
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Starting the Service Program Note Installation and further operation of the Service Program is described in its separate instructions for use. 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.
Fig.: 1 - 5
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System Overview
4.
Enter the password and confirm it by clicking the field “Start”.
Fig.: 1 - 6 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 - 7 The work window of the Service Program appears on the screen. All devices recognized are listed in the left column.
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