Service Manual
136 Pages
Preview
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Infusomat® 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 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: Languages of this Manual
Designation
Part No.
Service Manual Infusomat® Space, English... 8713 9120 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:
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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
Infusomat® 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 Checks and Repair Notes on ESD Spare Parts and Test Equipment Safety data sheets Setting Off Special PDF functions List of Abbreviations
Page Page Page Page Page Page Page Page Page Page Page Page Page
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
Contact Persons
Technical Training Entry for Technical Training Ordering of Spare Parts and Test Equipment Service Hotline Returns Safety Officer (§ 30 MPG)
Page Page Page Page Page
0 - 11 0 - 11 0 - 11 0 - 11 0 - 11
Page
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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 CAN error states The Most Important Error Modes Calibration
Page Page Page Page
2-1 2-7 2 - 10 2 - 10
Disassembly / Assembly
General Slide Guide Cover for Drop Sensor Connector Emergency Release Plug Unit Foot Battery Module Housing Upper Part Housing Bottom Part Inner Frame and Housing Front Panel Inner frame Housing Front Panel Operating Unit
Page Page Page Page Page Page Page Page Page Page Page Page
3-1 3-9 3 - 10 3 - 10 3 - 11 3 - 12 3 - 19 3 - 22 3 - 23 3 - 25 3 - 29 3 - 31
EN
Infusomat® Space 6.0
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Table of Contents
Processor PCB Installation / Assembly Pole Clamp SP Adapter Kit Checks after Repair
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3 - 37 3 - 40 3 - 54 3 - 55
Servicing the Unit
Cleaning and Disinfecting Servicing the Battery
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4-1 4-3
Technical Safety Check (TSC)
Infusomat® 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 Infusomat® Space Functional Inspection Power Supply SP
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6-1
Page Page Page
6-2 6-3 6 - 10
Test equipment Special Tools
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7-1 7-2
Page
8-1
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9-1
Index
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Infusomat® 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
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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:
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
EN
Infusomat® 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 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.
Infusomat® Space 6.0
EN
Important Preliminary Remarks
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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 the repair descriptions. 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 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.
EN
Infusomat® Space 6.0
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Important Preliminary Remarks
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 integrated, 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
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:
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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).
Infusomat® Space 6.0
EN
Important Preliminary Remarks
4.
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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.
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
EN
Infusomat® Space 6.0
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)
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Important Preliminary Remarks
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)
Infusomat® Space 6.0
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)
EN
Infusomat® Space 6.0
Dr. Ludwig Schütz e-mail: [email protected]
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Contact Persons
For your notes:
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Infusomat® Space 6.0
EN
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Description
System Overview
1
The Infusomat® Space (ISPS) is according to IEC/EN 60601-1 or IEC/EN 60601-2-24 a portable volumetric infusion pump for infusion of small to high volumes with ultimate precision and is suitable 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 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 using 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.
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: Item Designation 1
SpaceCover
2
Infusion pump Infusomat® Space
3
Infusion syringe pump Perfusor® Space
4
SpaceControl
5
SpaceStation
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Infusomat® 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 via the connected 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 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
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 springmounted 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 position 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)
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Slide guide with 12 slides (mechanically coded, can be dismantled without tool) Coding for ISPS: top left Coding for ISPP: middle right
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Air inline sensor
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Pressure sensor (downstream, patient-side)
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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 flexibly 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.
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Infusomat® Space 6.0
EN
1
System Overview
1
3
2
4 6
5
Fig.: 1 - 2 Infusomat® Space Legend of fig. 1 - 2: Item Designation 1
Infusomat® Space
2
Operating unit
3
Cover for drop sensor connector
EN
Infusomat® Space 6.0
4
Connector “P2“ for SpaceStation module, external 12 V DC and accessories
5
Connector “P3“, connection to SpaceControl module
6
Battery compartment cover
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1
System Overview
Function
There are two power options for the Infusomat® 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 keyboard and the display are lighted. The Infusomat® Space is connected to a SpaceControl by connector “P3”. The function processor controls all the functions of the Infusomat® 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
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Pressure sensor upstream (container-side) Monitors the upstream pressure (negative pressure)
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Air inline sensor Monitors the line contents (liquid - air)
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Temperature sensor Monitors the temperature of the medium in the line (integrated in the air inline sensor)
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Pressure sensor downstream (patient-side) Monitors the downstream pressure (overpressure)
The pump drive motor is monitored by a speed and direction of rotation 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.
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Infusomat® Space 6.0
EN
System Overview
1
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 linear 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 calibrations are carried out automatically, for example: -
occlusion test To check, for example, the function of the safety clamp
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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.
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Infusomat® Space 6.0
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1
System Overview
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 compartment cover.
Fig.: 1 - 3 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 - 4
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Infusomat® Space 6.0
EN
System Overview
1
4.
Turn the emergency release plug carefully with the emergency 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.
Fig.: 1 - 5 6.
Turn the emergency release crank to the right (clockwise according to arrow direction) until the operating unit is released and opens.
Fig.: 1 - 6
EN
Infusomat® Space 6.0
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1
System Overview
Fig.: 1 - 7 Block Diagram Infusomat® Space
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Infusomat® Space 6.0
EN