Infusomat Space Service Manual Ver 3.1 April 2012

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Infusomat® Space

Service Manual

Version 3.1 english

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1.0

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This Service Manual is valid for:

Designation

Part No.

Infusion Pump Infusomat® Space . . . . . . . . . . . . . . . . . 0871 3050

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 Infusomat® Space, English . . . . . . . . . 8713 9120

Designation

Part No.

Service Manual Infusomat® Space, German . . . . . . . . 8713 9110

Service Manual Infusomat® Space, English (us) . . . . 8713 9120U

Service Manual Infusomat® Space, French . . . . . . . . . 8713 9130

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Infusomat® Space, 1.0 gb

Page 4

3.1

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Table of Contents

Inner Frame

Housing Front Panel

Operating Unit

Processor PCB

Assembly / Installation

Pole Clamp SP Adapter Kit

Retrofitting of door jam

Checks after Repair

Page

Page

Page

Page

Page

Page

Page

Page

3 - 26

3 - 30

3 - 31

3 - 38

3 - 41

3 - 53

3 - 58

3 - 60

Servicing the Unit

Cleaning

Servicing the Battery

Page

Page

4-1

4-1

Technical Safety Check (TSC)

Infusomat® Space

Page

5-1

Technical Safety Check (TSC)

Power Supply SP

Page

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

Page

7-1

Page

Page

Page

7-2

7-3

7-8

Test Equipment

Special Tools

Page

Page

8-1

8-2

Page

9-1

Test Equipment and Special Tools

Spare Parts List

Safety Data Sheets

Klüber POLYLUB GLY 501

Page

10 - 1

Revision Documentation

Description of Version

Version List of the Individual Pages

Page

Page

11 - 1

11 - 2

Page

12 - 1

Index

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Infusomat® Space, 3.1 gb

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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 performed by persons, who

-

have received appropriate training on the system from

B. Braun,

-

are included in the revision service,

-

possess the necessary test equipment and mechanical aids,

and

-

fulfill the personal requirements (training and knowledge).

The user is obliged to perform or to have performed the Technical

Safety Checks on those medial products for which these checks

have been prescribed by the manufacturer and to carry them out

according to the indications of the manufacturer as well as the

generally approved technical standards while adhering to the periods stated (§ 6 MP BetreibV).

B. Braun also recommends training on the Technical Safety

Checks, or to perform at least the steps indicated in the current

version of the manual, as:

-

the TSC requires that the instructions in the manuals are observed,

-

the manuals are a reference for measurements,

-

depending on the unit type, the Service Program must be accessed 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

Possessing 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

-

technical training by B. Braun Melsungen or

-

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,

-

the device is used in accordance with the instructions for use

and the Service Manual,

-

the Technical Safety Checks are performed at regular intervals,

-

a current manual, which corresponds to the revision state, is

used when carrying out maintenance, repair and service,

-

the service technician takes part in the revision service,

-

the technician has participated in a technical training course

for the specific B. Braun unit.

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.

Infusomat® Space, 1.0 gb

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2.0

Important Preliminary Remarks

0

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. Conductive surface, soldering irons and 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 is 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 Apart

Additional notes and warnings are set apart as follows:

Note

Is used for additional or special notes concerning information and

working steps.

Infusomat® Space, 2.0 gb

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Important Preliminary Remarks

Warnings

DANGER

Imminent danger which can result in death or

serious injuries.

¾ Preventative measures.

Possible danger which can result in death or serious

injuries.

¾ Preventative measures.

WARNING

CAUTION

Possible danger which can result in slight injuries or

material damage.

¾ Preventative measures.

References to chapters are shown as follows

(see “Setting Apart“ ➨ p. 0 - 8)

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.

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Infusomat® Space, 2.0 gb

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1.1

Important Preliminary Remarks

List of Abbreviations

Infusomat® Space, 1.1 gb

0

Abbreviations which are not generally known, but are used in this

manual, are listed below.

CAN

Controller Area Network

CE

Communauté Européenne

CS

Calibration Step

DIN

German Industrial Norm

EN

European Norm

ESD

Electrostatic Discharge

FuP

Function Microprocessor

IEC

International Electrotechnical

Commission

ISO

International Organization for

Standardization

ISP

Infusomat® Space

ISPS

Infusomat® Space (Silicon)

ISPP

Infusomat® Space, (PVC)

CS

Calibration Step

KuP

Monitoring Microprocessor

LCD

Liquid Crystal Display

MOS

Shortname of the following

company:

MOS Technology, Inc.

(Commodore Semiconductor

Group)

PCA

Patient Controlled Analgesia

PSP

Perfusor® Space

SP

Space (System)

SPC

SpaceCover

SPCC

SpaceCover comfort

SPCS

SpaceCover standard

SPCO

SpaceCom

SPCT

SpaceControl

SPS

SpaceStation

TEMP

Temperature

TS

Trouble Shooting Step

TSC

Technical Safety Check

UTS

Unit Test Step

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Important Preliminary Remarks

VDE

0 - 10

Verband der Elektrotechnik,

Elektronik und

Informationstechnik e.V.

(german association of

engineers)

Infusomat® Space, 1.0 gb

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3.0

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Contact Persons

0

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)

Irene Marchel

Fax:

+49 5661 / 75 -38 57

e-mail: irene.marchel@bbraun.com

Service Hotline

Martin Heusner

Phone:

Fax:

e-mail:

+49 5661 / 71 - 35 25

+49 5661 / 71 - 35 26

martin.heusner@bbraun.com

Return of Spare Parts and Test Equipment

B. Braun Melsungen AG

Schwarzenberger Weg 73-79

Wareneingang Werk C

34 212 Melsungen

Germany

Safety Officer

(§ 30 MPG)

Dr. Ludwig Schütz

e-mail: ludwig.schuetz@bbraun.com

Infusomat® Space, 3.0 gb

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Infusomat® Space, 1.0 gb

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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.

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.

System Overview

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:

Item Designation

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.

1- 1

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1

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)

-

slide guide with 12 slides (mechanically coded, can be dismantled without tool)

coding for ISPS: top left

coding for ISPP: middle right

-

air inline sensor

-

pressure sensor (downstream, patient-side)

-

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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Infusomat® Space, 1.0 gb

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System Overview

1

3

2

4

6

5

Fig.: 1 - 2 Infusomat® Space

Legend to fig. 1 - 2:

Item Designation

1

Infusomat® Space

2

Operating unit

3

Cover for drop sensor connector

Infusomat® Space, 1.0 gb

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

-

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

-

pressure sensor, upstream (container-side)

monitors the upstream pressure (negative pressure)

-

air inline sensor

monitors the line contents (liquid - air)

-

temperature sensor

monitors the temperature of the medium in the line (integrated in the air inline sensor)

-

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.

1- 4

Infusomat® Space, 1.0 gb

Page 17

1.0

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 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.

Infusomat® Space, 1.0 gb

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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.

Fig.: 1 - 3

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.

Fig.: 1 - 4

1- 6

Infusomat® Space, 1.0 gb

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2.0

System Overview

1

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

Damage to the housing!

¾ Do not turn the emergency unlocking crank past

the stop.

Fig.: 1 - 5

6.

Turn the emergency unlocking crank to the right (clockwise

according to arrow direction) until the operating unit is released and opens.

Fig.: 1 - 6

Infusomat® Space, 2.0 gb

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System Overview

Fig.: 1 - 7 Block diagram Infusomat® Space

1- 8

Infusomat® Space, 1.0 gb

Page 21

3.1

System Overview

Unit Software

1

Approved Software Versions

686B030001

-

Basic software

686B030002

686B030003

686B030004

686C030001

-

Dose calculation

-

Changed CAN log

686D030001

-

Drug list data base

-

Changed user language

686E030002

-

Improved functions

-

Piggyback

-

Softlimits

686F030006

-

PCA function improvements

686G030002

-

Function improvements

686H030002

-

TCI

686J030003

-

New therapies

686J030005

-

Function improvements

Software Update of the Unit

The instructions for updating the software are supplied with the

software itself.

CAUTION

Infusomat® Space, 3.1 gb

Irreparable damage to a component of the unit

software!

¾ During the software update do not interrupt the

connection to the device and do not switch off

the PC either. Otherwise it will no longer be possible to carry out the software update via the PC

so that the device will have to be sent to

B. Braun.

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Page 22

3.1

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System Overview

Service Program

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

-

1.2.1

-

1.3.5

-

1.3.7

-

1.5.0

-

2.0.1

-

3.1.0

-

4.0.1

-

5.1.0

-

6.1.0

-

7.0.0

-

7.4.3.8

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 - 8

1 - 10

Infusomat® Space, 3.1 gb

Page 23

3.0

System Overview

4.

1

Enter the password and confirm it by clicking the field “Start”.

Fig.: 1 - 9

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 - 10

The work window of the Service Program appears on the

screen. All devices recognized are listed in the left column.

Infusomat® Space, 3.0 gb

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System Overview

Fig.: 1 - 11

5.

1 - 12

Activate the desired device from the list on the left in the

work window with a double-click. The device data is then displayed below the device name.

Infusomat® Space, 3.0 gb

Page 25

3.0

System Overview

1

If the unit software version is not compatible with the Service

Program version, a window opens prompting the operator to

change the Service Program version. This window displays a

compatibility list of the Service Program- and unit software

versions.

If Service Program and unit software versions are compatible,

all the Service Program functions are activated.

Fig.: 1 - 12

If the software was updated or the processor PCB was exchanged you are prompted to enter the device type. You can

select either the Infusomat® Space P or the Infusomat®

Space S.

Note

The designation “Infusomat® Space S“ corresponds to the Infusomat® Space.

Fig.: 1 - 13

6.

The device type must be confirmed again.

Fig.: 1 - 14

If the Service Program and the unit software are compatible, all

the Service Program functions are activated.

Infusomat® Space, 3.0 gb

1 - 13