Perfusor Space Service Manual Ver 6.0

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Perfusor® Space

Service Manual

Version 6.0 English

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Rx only

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This Service Manual is valid for

Designation

Part No.

Infusion Syringe Pump Perfusor® Space. . . . . . . . . . . . 08713030

Infusion Syringe Pump Perfusor® Space (USA) . . . . . 08713030U

Infusion Syringe Pump Perfusor® Space (Canada). . . 08713030C

Infusion Syringe Pump Perfusor® Space (China) . . . 08713030CN

Availability of this Manual

This Service Manual can be downloaded as PDF file under the following document number from the B. Braun Service Portal:

Designation

Doc. No.

Service Manual Perfusor® Space, English. . . . . . . M688_001152

Languages of this Manual

The Service Manual for this unit can be downloaded as PDF file in

the following languages from the B. Braun Service Portal:

Designation

Doc. No.

Service Manual Perfusor® Space, German . . . . . . . M688_001151

The complete Service Manual contains

the following pages:

0-2

Page 0-1 to Page 0-14

Page 1-1 to Page 1-14

Page 2-1 to Page 2-22

Page 3-1 to Page 3-58

Page 4-1 to Page 4-2

Page 5-1 to Page 5-4

Page 6-1 to Page 6-8

Page 7-1 to Page 7-4

Page 8-1 to Page 8-6

Page 9-1 to Page 9-2

Page 10-1 to Page 10-2

Perfusor® Space 6.0

EN

Page 4

0

Table of Contents

Pole Clamp SP adapter kit

Checks after Repair

Page

Page

3 - 54

3 - 55

Servicing the Unit

Cleaning and Disinfecting

Servicing the Battery

Page

Page

4-1

4-2

Technical Safety Check (TSC)

Perfusor® Space

Power Supply SP

Page

Page

5-1

5-4

Procedural Instructions on the TSC

Visual Inspection

Electrical Safety

according to IEC 60601-1 or IEC 62353

Functional Inspection Perfusor® Space

Functional Inspection Power Supply SP

Page

6-1

Page

Page

Page

6-2

6-3

6-7

Test equipment

Special Tools

Page

Page

7-1

7-3

Page

8-1

Page

9-1

Index

Page

10 - 1

0- 4

Perfusor® Space 6.0

Test Equipment and Special Tools

Spare Parts List

Revision Documentation

Description of Version

EN

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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

-

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 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

-

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.

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

Perfusor® Space 6.0

Not all software versions, hardware, or spare parts are available in

all regions. Please consult your local B. Braun representative for

availability.

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Important Preliminary Remarks

Responsibility of the Manufacturer

Quality Management

The manufacturer, person who assembles, installs or imports the

device can only be held responsible for safety, reliability and performance if

-

mounting, enhancements, new settings, changes or repairs

are carried out by duly authorized persons,

-

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 in the case of devices for which TSC checks are mandatory,

-

a current manual which corresponds to the revision state is

used when carrying out maintenance, repair and service,

-

the technician has participated in a technical training course

for the specific B. Braun unit.

B. Braun is certified to be compliant with DIN EN ISO 9001 and

ISO 13485. This certification also includes maintenance and service.

The device bears the CE mark. The CE mark indicates that the device is in conformity with the provisions of the COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.

Technical Training

Technical training may only be performed by B. Braun. The possession of the Service Manual does not authorize to perform repairs.

Checks after Repair

If the housing of the device has been opened completely (e.g., repairs beyond replacement of the battery or pole clamp), or if

maintenance work on the drive head has been carried out, the

checks after repair must be performed completely. In some cases,

even a calibration of the device may be required (a corresponding

message will be prompted by the device or service software).

The inspection efforts for the TSC and for the complete checks after repair are the same.

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Perfusor® Space 6.0

EN

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Important Preliminary Remarks

0

After minor repairs without having opened the housing the following items of the checklist for checks after repair must be performed:

Notes on ESD

-

Visual inspection, complete

-

Electrical safety

-

Simple functional inspection: Switch on, infusion, switch off.

Semiconductors can be destroyed by electrostatic discharge. Especially MOS components can be damaged by interference from

electrostatic fields, even without discharge via contact. This type

of damage is not immediately recognizable. Unit malfunctions

can even occur after a longer period of operation.

Each workstation must be equipped according to the recommendations with the necessary static protective measures, if ESD

components or boards are handled.

Each workstation must be equipped with a conductive table surface. The conductive surface, the soldering iron or the soldering

stations must be grounded via protective resistors.

Chairs must be of antistatic design. The floor or floor mats should

be of electrically conductive material.

Fig.: 0 - 1

Spare Parts

Personnel must wear conductive wristbands which are connected

to a central ground potential via protective resistors, e.g. the

ground contact of a wall outlet. Furthermore it is recommended

that personnel wear cotton clothing and electrically conductive

shoes to prevent electrostatic charge.

Only use original spare parts from B. Braun. Do not tamper with

them. Never integrate assembly groups into a device that have

been extracted from an other device.

When assembling spare parts with a serial or batch number (see

label on the packaging or number plate) the serial numbers of the

spare part and the affected medical device have to be documented.

Calibration of Gauges

B. Braun calibration gauges are delivered with a calibration certificate for the gauge itself. Calibration intervals are stated in this

document. Regular recalibrations of the gauge according to the

stated intervals are mandatory.

Additional recalibrations may be required in the following cases:

-

EN

Perfusor® Space 6.0

if a gauge has been repaired or modified,

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Important Preliminary Remarks

-

after an event which might potentially have compromised the

validity of the calibration, for example, after a gauge has

been exposed to shock, vibration, or physical damage,

-

whenever observations appear questionable or indications of

the gauge do not match the output of surrogate instruments.

Service personnel are responsible for assuring regular or additional recalibration of their test equipment at any time. Original test

equipment must be calibrated at the works of B. Braun. Further

information is available upon request.

Measuring Equipment

Additional measuring and test equipment used for servicing our

devices must comply with the following standards and/or measuring equipment specifications:

Electrical safety:

IEC 60601-1, ed 3.1

EN 62353

For example, Bender UNIMET 800/810ST

https://www.bender-de.com/en

or comparable

Pressure measurements:

Measurement accuracy ≤ 80 mbar (1.16 psi)

For example, Kobold MAN-SD1S5A30Y

http://kobold.com/en

or comparable

Flow accuracy:

Scales:

Measurement range 220 g

Linearity deviation ±0.1 g

Standard deviation ±0.05

Readability 0.01 g

For example, Sartorius CPA324S-OCE

https://www.sartorius.com/sartorius/en/EUR/home//

or comparable

Graduated cylinder:

Class A

Size 25 ml

Standard deviation ±0.040 ml

For example, ISOLAB Art. Y278.1

http://www.isolab.de/

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Perfusor® Space 6.0

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Important Preliminary Remarks

0

Safety data sheets

You can request the material safety data sheets for the consumables described in this Service Manual free of charge from

B. Braun. You can download the latest version of each document

as a PDF in the service portal under https://extranet.bbraun.com.

Setting Off

Additional notes and warnings are set off as follows:

Note

Is used for additional or special notes concerning information and

working steps.

CAUTION

Is used for working steps which may result in damage to the unit,

system or to a connected device.

! WARNING

IS USED FOR WORKING STEPS WHICH MAY RESULT IN PERSONAL

INJURY.

References to chapters are shown as follows

(see „Setting Off“ ➨ pg. 0 - 9)

References to figures and tables are shown as follows

Fig.: 2 - 3 or Table 2 - 1

References to item numbers in figures are shown as follows

(Fig.: 1 - 1 / Item 1)

In this case “Fig.: 1 - 1“ is the figure number and “Item 1“ the item

number within the figure.

When the Service Manual is stored as pdf-file, these references

are displayed green. Click with the mouse button on a reference

to jump to the corresponding source.

Menu commands are described as:

Menu File.

Special PDF functions

In the PDF format of this manual, special functionality is integrated, which can be used with Adobe® Reader®:

-

EN

Perfusor® Space 6.0

Form function

For completing, saving, and printing the TSC on a PC, laptop,

etc.

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Important Preliminary Remarks

Software requirements

-

Adobe® Reader® Version XI or higher is installed.

Form function

Fig.: 0 - 2

Forms included in the manual, which are to be filled out by the

reader, each show an "Edit" button at the top of the first page

(Fig.: 0 - 2). The list can be completed and printed online or saved

locally as a PDF:

1. Click the "Edit" button.

The form is opened in a separate PDF file.

2. If you want to save the form as a PDF, you can save an empty

copy of the form locally with File > Save As and open this for

editing.

3. The following form field functions are available:

-

Entry of text and figures in the form fields with the keyboard.

-

Checking test steps by clicking the check boxes (click

again to clear).

-

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).

-

Printing the completed form with File > Print and then

selecting a connected printer.

-

Saving the completed form as a PDF with File > Save.

4. To end the form, close the PDF file.

Note

After the PDF file has been closed, the entered data are only saved

if you were working in the local copy. This can be opened at any

time to continue editing.

List of Abbreviations

0 - 10

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

manual, are listed below.

CAN

Controller Area Network

CE

Communauté Européenne

(European Communities)

DIN

Deutsche Industrie Norm

(German Industrial Standard)

EN

European Standard

Perfusor® Space 6.0

EN

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0

Important Preliminary Remarks

EN

Perfusor® Space 6.0

ESD

Electrostatic Discharge

FuP

Function Microprocessor

IEC

International Electrotechnical

Commission

ISO

International Standardization

Organization

ISP

Infusomat® Space

ISPS

Infusomat® Space, Silicon

ISPP

Infusomat® Space, PVC

KuP

Monitoring Microprocessor

LCD

Liquid Crystal Display

MOS

Short for the following

company name:

MOS Technology, Inc.

(Commodore Semiconductor

Group)

PCA

Patient-Controlled Analgesia

PSP

Perfusor® Space

SP

Space (System)

SPC

SpaceCover

SPCC

SpaceCover comfort

SPCS

SpaceCover standard

SPCO

SpaceCom

SPCT

SpaceControl

SPS

SpaceStation

TEMP

Temperature

TSC

VDE

Technical Safety Checks

Verband der Elektrotechnik,

Elektronik und

Informationstechnik e.V.

(German electrical engineering

association)

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Important Preliminary Remarks

For your notes:

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Perfusor® Space 6.0

EN

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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)

e-mail: Spare-Parts_HC@bbraun.com

Service Hotline

Service Hotline International (without U.S. and Canada)

e-Mail: Service-Hotline_HC@bbraun.com

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

Perfusor® Space 6.0

Dr. Ludwig Schütz

e-mail: ludwig.schuetz@bbraun.com

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Contact Persons

For your notes:

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Perfusor® Space 6.0

EN

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1-

Description

System Overview

1

The Perfusor® Space (PSP) is according to IEC/EN 60601 resp. IEC/

EN 60601-2-24 a transportable infusion syringe pump for administrating fluids in the nutritional therapy and infusion technique

as well as for home care applications.

The medical specialist must decide on suitability for application

on the basis of the warranted properties and the technical data.

System Overview

The Space system is a modular design of modern infusion technology for stationary, mobile or private use. The key modules and

their connection to the peripheral devices are shown in Fig.: 1 1.

All the pump types, Perfusor® Space, Infusomat® Space and Infusomat® Space P, as well as the other devices of the system are of

modular design. Up to three pumps can be connected together

mechanically using L rails on the bottom of the unit and grooves

on the top. They can then be fastened to a drip stand or appropriate rail using the pole clamp.

1

2

The SpaceControl module can be used to extend operation. One

single pump can be inserted onto this module. The pump is then

connected via connectors to the module.

3

4

5

Fig.: 1 - 1 Space system

Legend of fig. 1 - 1:

ItemDesignation

1

SpaceCover

2

Infusion pump Infusomat® Space

3

Infusion syringe pump Perfusor® Space

4

SpaceControl

5

SpaceStation

EN

Perfusor® Space 6.0

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

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

every SpaceStation. The pumps are supplied with power via the

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

are connected to the optional SpaceCom via these connectors.

SpaceControl can also be integrated into the system.

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

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

24 pumps in maximum three columns is not exceeded.

SpaceCover Standard or SpaceCover Comfort forms the top of

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

1- 1

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1

System Overview

Physical Construction

1

2

5

4

3

6

8

7

Fig.: 1 - 2 Perfusor® Space

Legend of fig. 1 - 2:

ItemDesignation

1

Perfusor® Space

6

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

and accessories

2

Drive head

3

Syringe holder with piston brake

7

Connector “P3“, connection to SpaceControl module

4

Operating Unit

8

Battery compartment cover

5

Syringe area

1- 2

Perfusor® Space 6.0

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System Overview

1

The Perfusor® Space housing mainly consists of the bottom part

and the upper part.

The battery module is inserted in the rear of the housing upper

part. The opening is covered by the battery compartment cover.

The operating unit is attached to the front of the bottom part with

two hinges. This operating unit covers the area for the syringes.

The complete drive assembly, consisting of lead screw and drive

head with driving tube is located directly behind the syringe area

in the bottom part of the housing. The housing bushing for the

driving tube is located in the side of the housing.

The syringe holder is mounted in the right side of the housing bottom part.

The processor PCB with the permanently connected external connectors “P2” and “P3” is located at the bottom of the housing bottom part.

Function

There are two power options for the Perfusor® Space:

-

via the inserted battery module

-

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.

EN

Perfusor® Space 6.0

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System Overview

The pressure in the infusion system is measured through a strain

gauge measuring in the drive head and monitored in the device

electronics. The data from the strain gauge is continuously compared with the limit values which are calculated dependent on the

selected syringe type and the pressure settings. When the limit

values are exceeded an alarm is automatically triggered and the

pressure in the infusion system is reduced. The maximum pressure

is additionally limited by a second, independent system. This maximum pressure limitation is performed using the motor current

control.

The syringe size detection is performed via the syringe holder. The

syringe holder is connected to a potentiometer. The syringe size is

determined from the resistance of the potentiometer.

The syringe is fixed with the syringe holder and the axial fastening

device. The syringe piston is fastened with two claws in the drive

head. When a syringe is inserted the syringe piston is held by the

piston brake, until the piston has been caught by the claws.

Keyboard and display as well as the syringe area are illuminated.

1- 4

Perfusor® Space 6.0

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System Overview

1

Fig.: 1 - 3 Block diagram Perfusor® Space

EN

Perfusor® Space 6.0

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System Overview

History*

Unit Software

Position

1 2 3 4 5 6 7 8 9 10

Digit

6 8 8 F 0 3 0 0 0 6

Revision level

Hardware

Software group

Device type: Perfusor® Space

Fig.: 1 - 4

The software version history started with software group A. It is

unlikely, however, that older versions than software group F are

still present in the markets.

688F030006

-

PCA

-

Changed claw configuration

-

Optimized alarm handling

688G030002

-

Improved functions

688H030002

-

TCI

688J030006

-

Therapy profiles

688L030003

-

Take-over mode

-

Occlu Guard

-

Changed recognition of service connector

688L033001 (for China only)

-

Modified alerting

688M030001 and higher

-

Improved functions

688N030001 and higher

-

TCI for sufentanil

-

Sensitive pressure level

588U030001 (for US only)

-

Modified user interface

* Not all software versions, hardware, or spare parts are available in all regions.

Please consult your local B. Braun representative for availability.

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Perfusor® Space 6.0

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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 HiBaSeD

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.

Version HiBaSeD

for Unit Software Versions

4.6.0 . . . . . . . . . . . . . . . . . . . . . . . . . . 688F030001 - 688F030006

5.0.0 . . . . . . . . . . . . . . . . . . . . . . . . . 688G030001 - 688G030001

5.1.0 . . . . . . . . . . . . . . . . . . . . . . . . . 688G030002 - 688G030099

6.0.0 . . . . . . . . . . . . . . . . . . . . . . . . . 688H030001 - 688H030001

6.1.0 . . . . . . . . . . . . . . . . . . . . . . . . . 688H030002 - 688H030002

7.4.38 . . . . . . . . . . . . . . . . . . . . . . . . . 688J030001 - 688J030006

8.0.1 . . . . . . . . . . . . . . . . . . . . . . . . . . 688L030001 - 688L070001

9.0.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 688M030001 and higher

10.0.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 688N030001 and higher

US1.0.0 . . . . . . . . . . . . . . . . . . . . . . . . . . 588U030001 and higher

EN

Perfusor® Space 6.0

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System Overview

Starting the Service Program

Note

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 - 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 6.0

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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.

EN

Perfusor® Space 6.0

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.

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Page 24

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 6.0

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Page 25

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

EN

Perfusor® Space 6.0

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