Service Manual
138 Pages
Preview
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Perfusor® Space Service Manual
Version 6.0 English
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Rx only
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This Service Manual is valid for
Designation
Part No.
Infusion Syringe Pump Perfusor® Space... 08713030 Infusion Syringe Pump Perfusor® Space (USA)... 08713030U Infusion Syringe Pump Perfusor® Space (Canada). . . 08713030C Infusion Syringe Pump Perfusor® Space (China) . . . 08713030CN Availability of this Manual
This Service Manual can be downloaded as PDF file under the following document number from the B. Braun Service Portal: Designation
Doc. No.
Service Manual Perfusor® Space, English... M688_001152 Languages of this Manual
The Service Manual for this unit can be downloaded as PDF file in the following languages from the B. Braun Service Portal: Designation
Doc. No.
Service Manual Perfusor® Space, German... M688_001151 The complete Service Manual contains the following pages:
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Page 0-1 to Page 0-14 Page 1-1 to Page 1-14 Page 2-1 to Page 2-22 Page 3-1 to Page 3-58 Page 4-1 to Page 4-2 Page 5-1 to Page 5-4 Page 6-1 to Page 6-8 Page 7-1 to Page 7-4 Page 8-1 to Page 8-6 Page 9-1 to Page 9-2 Page 10-1 to Page 10-2
Perfusor® Space 6.0
EN
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Table of Contents
0
Important Preliminary Remarks
Service Work Technical Safety Checks Current Versions Product availability Responsibility of the Manufacturer Quality Management Technical Training Checks after Repair Notes on ESD Spare Parts Calibration of Gauges Measuring Equipment Safety data sheets Setting Off Special PDF functions 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 0-7 0-8 0-9 0-9 0-9 0 - 10
Contact Persons
Technical Training Entry for Technical Training Ordering of Spare Parts and Test Equipment Service Hotline Returns Safety Officer (§ 30 MPG)
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0 - 13 0 - 13 0 - 13 0 - 13 0 - 13
Page
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System Overview
Description System Overview Physical Construction Function Unit Software Service Program HiBaSeD Technical Data Options Accessories Functional test
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1-1 1-1 1-2 1-3 1-6 1-7 1 - 12 1 - 12 1 - 12 1 - 13
Unit Diagnosis / Calibration
Alarms and Error Codes CAN error states Calibration
Page Page Page
2-1 2-7 2-9
Disassembly / Assembly
General Battery Module Housing Foot Operating Unit Upper Part of Housing Release Button Loudspeaker Drive Syringe Holder with Piston Brake Processor PCB Assembly / Installation
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3-1 3-9 3 - 16 3 - 17 3 - 22 3 - 24 3 - 24 3 - 25 3 - 32 3 - 39 3 - 40
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Perfusor® Space 6.0
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Table of Contents
Pole Clamp SP adapter kit Checks after Repair
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3 - 54 3 - 55
Servicing the Unit
Cleaning and Disinfecting Servicing the Battery
Page Page
4-1 4-2
Technical Safety Check (TSC)
Perfusor® Space Power Supply SP
Page Page
5-1 5-4
Procedural Instructions on the TSC
Visual Inspection Electrical Safety according to IEC 60601-1 or IEC 62353 Functional Inspection Perfusor® Space Functional Inspection Power Supply SP
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6-1
Page Page Page
6-2 6-3 6-7
Test equipment Special Tools
Page Page
7-1 7-3
Page
8-1
Page
9-1
Index
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Perfusor® Space 6.0
Test Equipment and Special Tools Spare Parts List Revision Documentation
Description of Version
EN
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Service Work
Technical Safety Checks
Important Preliminary Remarks
0
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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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:
Current Versions
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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.
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. 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 completion of a technical training course..
Product availability
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Perfusor® Space 6.0
Not all software versions, hardware, or spare parts are available in all regions. Please consult your local B. Braun representative for availability.
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Important Preliminary Remarks
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 in the case of devices for which TSC checks are mandatory,
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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 technician has participated in a technical training course for the specific B. Braun unit.
B. Braun is certified to be compliant with DIN EN ISO 9001 and ISO 13485. This certification also includes maintenance and service. The device bears the CE mark. The CE mark indicates that the device is in conformity with the provisions of the COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
Technical Training
Technical training may only be performed by B. Braun. The possession of the Service Manual does not authorize to perform repairs.
Checks after Repair
If the housing of the device has been opened completely (e.g., repairs beyond replacement of the battery or pole clamp), or if maintenance work on the drive head has been carried out, the checks after repair must be performed completely. In some cases, even a calibration of the device may be required (a corresponding message will be prompted by the device or service software). The inspection efforts for the TSC and for the complete checks after repair are the same.
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Important Preliminary Remarks
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After minor repairs without having opened the housing the following items of the checklist for checks after repair must be performed:
Notes on ESD
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Visual inspection, complete
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Electrical safety
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Simple functional inspection: Switch on, infusion, switch off.
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. 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
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 B. Braun. Do not tamper with them. Never integrate assembly groups into a device that have been extracted from an other device. When assembling spare parts with a serial or batch number (see label on the packaging or number plate) the serial numbers of the spare part and the affected medical device have to be documented.
Calibration of Gauges
B. Braun calibration gauges are delivered with a calibration certificate for the gauge itself. Calibration intervals are stated in this document. Regular recalibrations of the gauge according to the stated intervals are mandatory. Additional recalibrations may be required in the following cases: -
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Perfusor® Space 6.0
if a gauge has been repaired or modified,
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Important Preliminary Remarks
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after an event which might potentially have compromised the validity of the calibration, for example, after a gauge has been exposed to shock, vibration, or physical damage,
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whenever observations appear questionable or indications of the gauge do not match the output of surrogate instruments.
Service personnel are responsible for assuring regular or additional recalibration of their test equipment at any time. Original test equipment must be calibrated at the works of B. Braun. Further information is available upon request. Measuring Equipment
Additional measuring and test equipment used for servicing our devices must comply with the following standards and/or measuring equipment specifications: Electrical safety: IEC 60601-1, ed 3.1 EN 62353 For example, Bender UNIMET 800/810ST https://www.bender-de.com/en or comparable Pressure measurements: Measurement accuracy ≤ 80 mbar (1.16 psi) For example, Kobold MAN-SD1S5A30Y http://kobold.com/en or comparable Flow accuracy: Scales:
Measurement range 220 g Linearity deviation ±0.1 g Standard deviation ±0.05 Readability 0.01 g
For example, Sartorius CPA324S-OCE https://www.sartorius.com/sartorius/en/EUR/home// or comparable Graduated cylinder:
Class A Size 25 ml Standard deviation ±0.040 ml
For example, ISOLAB Art. Y278.1 http://www.isolab.de/
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EN
Important Preliminary Remarks
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Safety data sheets
You can request the material safety data sheets for the consumables 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. References to chapters are shown as follows (see „Setting Off“ ➨ pg. 0 - 9) 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 integrated, which can be used with Adobe® Reader®: -
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Perfusor® Space 6.0
Form function For completing, saving, and printing the TSC on a PC, laptop, etc.
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Important Preliminary Remarks
Software requirements -
Adobe® Reader® Version XI or higher is installed.
Form function
Fig.: 0 - 2
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 keyboard.
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Checking test steps by clicking the check boxes (click again to clear).
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Deletion of non-applicable test steps by marking the entry with the mouse and selecting “Strikethrough Text” in the shortcut menu (right mouse key; only for editing in the local form copy).
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Printing the completed form with File > Print and then selecting a connected printer.
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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
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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
Perfusor® Space 6.0
EN
0
Important Preliminary Remarks
EN
Perfusor® Space 6.0
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
TSC VDE
Technical Safety Checks Verband der Elektrotechnik, Elektronik und Informationstechnik e.V. (German electrical engineering association)
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Important Preliminary Remarks
For your notes:
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EN
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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) e-mail: [email protected]
Service Hotline
Service Hotline International (without U.S. and Canada) e-Mail: [email protected] Service Hotline U.S. and Canada Phone: +1 800-627-PUMP Phone: +1 800-627-7867
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)
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Perfusor® Space 6.0
Dr. Ludwig Schütz e-mail: [email protected]
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Contact Persons
For your notes:
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Perfusor® Space 6.0
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1-
Description
System Overview
1
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
4 5
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
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Perfusor® Space 6.0
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.
1- 1
1
System Overview
Physical Construction 1
2
5
4
3
6 8
7
Fig.: 1 - 2 Perfusor® Space Legend of fig. 1 - 2: ItemDesignation 1
Perfusor® Space
6
Connector “P2“ for SpaceStation module, external 12 V DC and accessories
2
Drive head
3
Syringe holder with piston brake
7
Connector “P3“, connection to SpaceControl module
4
Operating Unit
8
Battery compartment cover
5
Syringe area
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Perfusor® Space 6.0
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System Overview
1
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
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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.
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Perfusor® Space 6.0
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System Overview
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.
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Perfusor® Space 6.0
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System Overview
1
Fig.: 1 - 3 Block diagram Perfusor® Space
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Perfusor® Space 6.0
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System Overview
History*
Unit Software Position
1 2 3 4 5 6 7 8 9 10
Digit
6 8 8 F 0 3 0 0 0 6 Revision level Hardware Software group Device type: Perfusor® Space
Fig.: 1 - 4
The software version history started with software group A. It is unlikely, however, that older versions than software group F are still present in the markets. 688F030006 -
PCA
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Changed claw configuration
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Optimized alarm handling
688G030002 -
Improved functions
688H030002 -
TCI
688J030006 -
Therapy profiles
688L030003 -
Take-over mode
-
Occlu Guard
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Changed recognition of service connector
688L033001 (for China only) -
Modified alerting
688M030001 and higher -
Improved functions
688N030001 and higher -
TCI for sufentanil
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Sensitive pressure level
588U030001 (for US only) -
Modified user interface
* Not all software versions, hardware, or spare parts are available in all regions. Please consult your local B. Braun representative for availability.
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Perfusor® Space 6.0
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