Infusomat Space Service Manual Ver 1.0

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Table of Contents

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Important Preliminary Remarks

Service Work Technical Safety Checks Current Versions Revision Service Quality Management Checks and Repair Notes on ESD Spare Parts and Test Equipment Setting Off

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0-5 0-5 0-5 0-5 0-6 0-6 0-6 0-7 0-7

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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Page Page

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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 1-4 1-8 1-9 1 - 14 1 - 14 1 - 14

Unit Diagnosis / Calibration

General Alarms and Error Codes The Most Important Error Modes Device Check Procedural Instructions for the Device Check Calibration Procedural Instructions for Calibration Further Trouble Shooting

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2-1 2-3 2-8 2-9 2 - 12 2 - 13 2 - 13 2 - 18

Disassembly / Assembly

General Slide Guide Cover for Drop Sensor Connector Emergency Release Plug Unit Foot Battery Module Housing Upper Part Loudspeaker Housing Bottom Part Inner Frame and Housing Front Panel Inner Frame Housing Front Panel Operating Unit

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3-1 3-9 3-9 3 - 10 3 - 11 3 - 12 3 - 14 3 - 17 3 - 17 3 - 19 3 - 21 3 - 24 3 - 25

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Table of Contents

Processor PCB Assembly / Installation Checks after Repair

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3 - 29 3 - 30 3 - 41

Servicing the Unit

Cleaning Servicing the Battery

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4-1 4-1

Technical Safety Check (TSC)

Infusomat® Space

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5-1

Technical Safety Check (TSC)

Power Supply SP

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6-1

Procedural Instructions on the TSC

Visual Inspection Electrical Safety according to IEC/EN 60601-1 or VDE 0750 and VDE 0751 Functional Inspection Infusomat® Space Functional Inspection Power Supply SP

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7-2 7-3 7-8

Test Equipment Special Tools

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8-1 8-2

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9-1

Test Equipment and Special Tools

Spare Parts List Safety Data Sheets

Klüber POLYCLUB GLY 501

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Revision Documentation

Description of Version Version List of the Individual Pages

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11 - 1 11 - 1

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Index

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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 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

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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:

Infusomat® Space, 1.0 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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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,

-

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

0- 6

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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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 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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Important Preliminary Remarks

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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Important Preliminary Remarks

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

Monitoring 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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Important Preliminary Remarks

For your notes:

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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

1

The Infusomat® Space (ISP) 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. 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 to fig. 1 - 1: ItemDesignation 1

SpaceCover

2

Infusion pump Infusomat® Space

3

Infusion syringe pump Perfusor® Space

4

SpaceControl

5

SpaceStation

Infusomat® Space, 1.0 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

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 door bolt is used to lock the operating unit. In case of an emergency, the operating device 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 door bolt. The door bolt drive 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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System Overview

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3

2

4 6

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Fig.: 1 - 2 Infusomat® Space Legend to fig. 1 - 2: ItemDesignation 1

Infusomat® Space

2

Operating unit

3

Cover for drop sensor connector

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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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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 detector for speed and direction of rotation. The motor of the door bolt drive is controlled via the processor PCB. The different positions of the door bolt during operation are monitored by a linear potentiometer.

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System Overview

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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 door 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 device is opened the slide clamp is pulled out of the safety clamp until the Infusomat® Space line is squeezed. 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 door 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 door bolt changes. The locking process is started and can take up to 10 seconds. During the locking process several calibrations are carried out automatically, e.g.: -

occlusion test 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 door bolt. In case of a power failure or malfunction, the operating unit can be unlocked manually by a small emergency unlocking crank. To do so, move the door bolt manually with the crank to the open position as described hereafter.

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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 unlocking crank out of the battery compartment cover.

3.

Press the emergency unlocking crank carefully in the emergency unlocking plug on the left side of the housing until stop.

Note The hexagon socket of the emergency unlocking plug is tapered to the inside. If the emergency unlocking crank is not inserted until stop, the hexagon socket may be damaged. 4.

Turn the emergency unlocking plug carefully with the emergency unlocking crank through 90° to the right (clockwise in arrow direction) until stop and remove the plug out of the housing.

5.

Insert the emergency unlocking crank in the housing opening. The crank must be pushed in the hexagon socket of the door bolt drive.

CAUTION Make sure that the emergency unlocking crank is not turned beyond the stop by force. 6.

1- 6

Turn the emergency unlocking crank to the right (clockwise according to arrow direction) until the operating unit is released and opens.

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System Overview

1

Fig.: 1 - 3 Block diagram Infusomat® Space

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System Overview

Unit Software

Approved Software Versions 686B030001 -

Basic software

686B030002 -

Improved functions

-

Move door bolt in pumping position just before occlusion test (safety clamp opens)

686B030003 -

Improved functions

-

CAN bus functioning

686B030004 -

Improved functions

686C030001 -

Dose calculation

-

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 Versions 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. -

1.1.4

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1.2.1

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1.3.5

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1.3.7

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1.5.0

Starting Note the Service Program 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 - 4

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