Perfusor Space Service Manual Ver 2.0.1

Page 1

0-12

Perfusor® Space

Service Manual

Version 2.0.1 English

0-

Page 2

0

This Service Manual is valid for:

Designation

Part No.

Infusion syringe pump Perfusor® Space . . . . . . . . . . . . 0871 3030

This Service Manual is available under

the following part number:

Designation

Part No.

Languages of this Manual

The Service Manual for this unit can be supplied in the following

languages:

Service Manual Perfusor® Space, English. . . . . . . . . . . 8713 9020

Designation

Part No.

Service Manual Perfusor® Space, German . . . . . . . . . . 8713 9010

Service Manual Perfusor® Space, English (US). . . . . . 8713 9020U

Service Manual Perfusor® Space, French . . . . . . . . . . . 8713 9030

The complete Service Manual contains

the following pages:

0-2

Page 0-1 to page 0-12

Page 1-1 to page 1-12

Page 2-1 to page 2-30

Page 3-1 to page 3-60

Page 4-1 to page 4-2

Page 5-1 to page 5-2

Page 6-1 to page 6-2

Page 7-1 to page 7-6

Page 8-1 to page 8-4

Page 9-1 to page 9-6

Page 10-1 to page 10-2

Page 11-1 to page 11-2

Perfusor® Space 2.0.1 gb

Page 4

0

Table of Contents

Servicing the Unit

Cleaning

Servicing the Battery

Page

Page

4-1

4-1

Technical Safety Check (TSC)

Perfusor® 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 Perfusor® Space

Functional Inspection Power Supply SP

Page

7-1

Page

Page

Page

7-2

7-3

7-6

Test equipment

Special Tools

Page

Page

8-1

8-3

Page

9-1

Page

10 - 1

Page

11 - 1

Test Equipment and Special Tools

Spare Parts List

Revision Documentation

Index

0- 4

Description of Version

Perfusor® Space 2.0.1 gb

Page 5

0-

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

-

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

called which may lead to a dangerous unit condition in case

of inappropriate operation. Furthermore, a special service

connector may be necessary.

Current Versions

This manual version corresponds to the state when the manual

was written. B Braun reserves the right to make technical modifications. The state of the revision is indicated by the index number

in the footer of every page.

Revision Service

The possession of this manual does not automatically mean inclusion in the revision service. You will be included in the revision

service after:

Perfusor® Space 2.0.1 gb

-

technical training by B. Braun Melsungen or

-

a written order placed with the sales department of B. Braun

(fee required).

0- 5

Page 6

0

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.

Perfusor® Space 2.0.1 gb

Page 7

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. 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.

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.

Perfusor® Space 2.0.1 gb

0- 7

Page 8

0

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.

0- 8

Perfusor® Space 2.0.1 gb

Page 9

Important Preliminary Remarks

List of Abbreviations

Perfusor® Space 2.0.1 gb

0

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

manual, are listed below.

CAN

Controller Area Network

CE

Communauté Européenne

(European Communities)

CS

Calibration Step

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)

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

Troubleshooting Step

TSC

Technical Safety Checks

0- 9

Page 10

0

0 - 10

Important Preliminary Remarks

UTS

Unit Test Step

VDE

Verband der Elektrotechnik,

Elektronik und

Informationstechnik e.V.

(German electrical engineering

association)

Perfusor® Space 2.0.1 gb

Page 11

0 - 12

0-

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 (0) 5661 / 75 - 38 57

e-mail: irene.marchel@bbraun.com

Service Hotline

Karl Tippel, Martin Heusner

Phone:

+49 (0) 56 61 71 - 35 25

Fax:

+49 (0) 56 61 71 - 35 26

E-Mail: karl.tippel@bbraun.com

E-Mail: 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

Perfusor® Space 2.0.1 gb

0 - 11

Page 12

0

Contact Persons

For your notes:

0 - 12

Perfusor® Space 2.0.1 gb

Page 13

1 - 12

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

Perfusor® Space 2.0.1 gb

The SpaceStation module allows the set-up of a complete pump

system with up to 24 pumps. Up to four pumps can be installed in

every SpaceStation. The pumps are supplied with power via the

integrated power supply and the built-in connectors. The pumps

are connected to the optional SpaceCom via these connectors.

SpaceControl can also be integrated into the system.

Up to six SpaceStations can be set-up as a column with a total of

24 pumps. SpaceStation placed next to each other can be connected via special connection cables, if the maximum number of

24 pumps in maximum three columns is not exceeded.

SpaceCover Standard or SpaceCover Comfort forms the top of

each column. Alarms are signalled by a row of LEDs and a loudspeaker in the SpaceCover Comfort.

1- 1

Page 14

1

System Overview

Physical Construction

1

2

5

4

3

6

8

7

Fig.: 1 - 2 Perfusor® Space

Legend of fig. 1 - 2:

ItemDesignation

6

Connector “P2“ for SpaceStation module, external 12 V DC

and accessories

Syringe holder with piston brake

7

Connector “P3“, connection to SpaceControl module

4

Operating Unit

8

Battery compartment cover

5

Syringe area

1

Perfusor® Space

2

Drive head

3

1- 2

Perfusor® Space 2.0.1 gb

Page 15

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

-

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.

Perfusor® Space 2.0.1 gb

1- 3

Page 16

1

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.

1- 4

Perfusor® Space 2.0.1 gb

Page 17

System Overview

1

Fig.: 1 - 3 Block diagram Perfusor® Space

Perfusor® Space 2.0.1 gb

1- 5

Page 18

1

System Overview

Unit Software

Approved Software Versions

Position

1 2 3 4 5 6 7 8 9 10

Digit

6 8 8 C 0 3 0 0 0 1

Revision level

Hardware

Software group

Device type: Perfusor® Space

Fig.: 1 - 4

688A030032

-

Basic software

688A030035

-

Improved functions

688A030040

-

Improved functions

-

Languages French and Swedish added

688B030002

-

Improved functions

688B030003

-

CAN bus functioning

688C030001

-

Dose calculation

-

Changed CAN log

688D030001

-

Drug list data base

-

Changed user language

688E030003

-

Improved functions

-

Piggyback

-

Soft limits

688F030006

-

PCA

-

Changed claw configuration

-

Optimized alarm handling

688G030002

-

Improved functions

688H030002

-

1- 6

TCI

Perfusor® Space 2.0.1 gb

Page 19

System Overview

1

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.

Service Program

Approved Version

Note

Please note that text and / or functions of the Service Program

may change depending on the software version. The following

screen illustrations are only examples and represent the state

when the manual was printed.

-

0.0.28

-

1.0.0

-

1.1.2

-

1.1.3

-

1.1.4

-

1.2.1

-

1.3.5

-

1.5.0

-

2.0.1

-

3.1.0

-

4.0.0

-

5.1.0

-

6.1.0

Starting the Service Program

Note

Installation and further operation of the Service Program is described in its separate instructions for use.

Perfusor® Space 2.0.1 gb

1- 7

Page 20

1

System Overview

1.

Start the “HiBaSeD.exe” program (History, Barcode, Service,

Drug list) on the PC. The Service Program is loaded and started and the initial window of the Service Program is displayed.

2.

Read the notes carefully.

3.

Mark the field “I accept all conditions” and then the field

“Yes” to confirm that you have read the notes.

Note

Click the field “English” to switch the language of the notes over

to English.

Fig.: 1 - 5

4.

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

Fig.: 1 - 6

The Service Program checks the PC interfaces for connected

devices of the Space system. Units that were found are displayed for a short moment on the screen.

Fig.: 1 - 7

1- 8

Perfusor® Space 2.0.1 gb

Page 21

System Overview

1

The work window of the Service Program appears on the

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

Fig.: 1 - 8

5.

Perfusor® Space 2.0.1 gb

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.

1- 9

Page 22

1

System Overview

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 - 9

Fig.: 1 - 10

1 - 10

Perfusor® Space 2.0.1 gb

Page 23

System Overview

1

Service Program Version

1.

Open the “HiBaSeD“ window via Help ➨ Info .... The current

version of the Service Program is shown in this window.

2.

Close the window by clicking “OK”.

Fig.: 1 - 11

Compatibility List

1.

Open the “Unit - Compatibility” window via Help ➨ Compatibility. This window displays the compatibility of the HiBaSeD-version and the unit software version.

2.

Close the window by clicking “OK”.

Fig.: 1 - 12

Quit the Service Program

Perfusor® Space 2.0.1 gb

1.

Exit the Service Program via Application ➨ Quit.

2.

Disconnect a power supply which might be connected from

the unit.

3.

Switch off the unit.

4.

Remove the battery module.

5.

The device can be restarted after appr. 10 seconds.

1 - 11

Page 24

1

System Overview

Technical Data

All technical data is indicated in the instructions for use.

Options

The functions of the individual options are detailed in the instructions for use.

Perfusor® Space

Designation

Part No.:

Power supply Euro . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3110A

Power supply UK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3111A

Power supply USA / Japan . . . . . . . . . . . . . . . . . . . . . . 0871 3112A

Power supply Australia. . . . . . . . . . . . . . . . . . . . . . . . . 0871 3113A

Power supply South Africa. . . . . . . . . . . . . . . . . . . . . . 0871 3115A

Accessories

Designation

Part No.:

Charger SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3170

battery charging station

Connection cable staff call SP. . . . . . . . . . . . . . . . . . . . 0871 3232

Power supply cable 12 V . . . . . . . . . . . . . . . . . . . . . . . . 0871 3231

for ambulance cars

CombiLead SP 12 V . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3133

connection cable, pump - pump

InterfaceLead SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3234

interface cable RS232

InterfaceLead SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3230

interface cable CAN SP

SpaceClamp SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3130

The SpaceClamp is a holder attached on beds for one

or several Space system pumps.

Short stand SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0871 3135

Space PCA kit (PCA button) . . . . . . . . . . . . . . . . . . . . . 0871 3554

Syringe Anti Removal Cap PSP . . . . . . . . . . . . . . . . . . . 0871 3556

1 - 12

Perfusor® Space 2.0.1 gb

Page 25

2 - 30

2-

Unit Diagnosis / Calibration

General

2

! WARNING

While testing the unit and trouble shooting the operator/service

technician must work with voltages up to 115 / 230 V AC.

THESE VOLTAGES MAY CAUSE INJURIES WHICH ARE DANGEROUS

TO LIFE AND LIMB.

-

The national and international safety regulations are to be

adhered to.

Before each disassembly and assembly of a unit subsystem check

the connectors, plug contacts and connections for corrosion and

tight fit. These fault types are not described again in the following

trouble shooting list.

The following equipment and gauges are necessary for testing the

unit and/or performing troubleshooting:

-

PC

-

Service connector SP

-

Service Program HiBaSeD

-

Interface cable

-

Syringe 2 ml / 3 ml

-

Syringe 10 ml

-

Syringe 30 ml

-

Diameter gauge 32.0 mm

-

Diameter gauge 23.4 mm

-

Diameter gauge 15.7 mm

-

Diameter gauge 9.0 mm

-

Length gauge PSP

-

Syringe gauge “#Lehre OPS 50“with push-button plate and

motor power test adapter for Perfusor® Space

There are pictures of the gauges in Chapter “Special Tools“ (➨

pg. 8 - 3).

CAUTION

Take special care when carrying out measurements on an open

and switched-on unit. Short circuits and wrong measuring methods can cause serious damage to or destroy the subsystems of the

device.

Perfusor® Space 2.0.1 gb

2- 1