SpaceStation, SpaceCover and SpaceCom Service Manual Rev 4.0 Sept 2011

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This Service Manual is valid for:

Designation

Part No.

SpaceStation without SpaceCom... 0871 3140 SpaceStation with SpaceCom... 0871 3142 SpaceCover standard... 0871 3147 SpaceCover comfort... 0871 3145 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 SpaceStation, English... 8713 9220

Designation

Part No.

German... 8713 9210 English (US)... 8713 9220U French... 8713 9230

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Table of Contents

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Important Preliminary Remarks

Service Work Technical Safety Checks Current Versions Revision Service Responsibility of the Manufacturer Quality Management Checks and Repair Notes on ESD Spare Parts and Test Equipment Setting Apart List of Abbreviations

Page 0-7 Page 0-7 Page 0-7 Page 0-7 Pager 0 - 8 Page 0-8 Page 0-8 Page 0-8 Page 0-9 Page 0-9 Page 0 - 11

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)

Page Page Page Page Page Page

0 - 13 0 - 13 0 - 13 0 - 13 0 - 13 0 - 13

System Overview

Description Page System Overview Page Physical construction Page Function Page Unit Software Page Service Program Page SpaceOnline Page (only required with SpaceStation with SpaceCom) Page BCCshow Page Technical Data Page Options Page Accessories Page

1-1 1-1 1-2 1-6 1 - 13 1 - 15 1 - 18 1 - 18 1 - 20 1 - 22 1 - 22 1 - 22

Unit Diagnosis / Calibration

General Alarms and Error Codes CAN error states Device Check Device Check SpaceCom Trouble shooting

Page Page Page Page Page Page

2-1 2-3 2-4 2-6 2-7 2-8

Disassembly / Assembly SpaceStation

General on the SpaceStation without SpaceCom Tube guide Pole clamp guide Housing back panel Device bracket Power supply Release button Interface Board / Module Lock Housing

Page Page Page Page Page Page Page Page Page

3-1 3-3 3-4 3-5 3-6 3-7 3 - 12 3 - 13 3 - 21

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Table of Contents

Assembly / Installation Checks after Repair

Page Page

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Disassembly / Assembly SpaceCom

General on the SpaceStation with SpaceCom Optional battery pack SP Optional W-LAN Optional W-LAN USB stick Tube guide Pole clamp guide Housing back panel Device bracket PCB SPCO Further Disassembly Assembly / Installation Checks after Repair

Page Page Page Page Page Page Page Page Page Page Page Page

4-1 4-3 4-4 4-5 4-6 4-6 4-7 4 - 10 4 - 11 4 - 12 4 - 13 4 - 18

Disassembly / Assembly SpaceCover

General Battery compartment cover Battery pack (Only SpaceCover Comfort) Handle Housing upper and bottom part Housing back panel Loudspeaker (Only SpaceCover Comfort) Processor PCB Assembly / Installation Checks after Repair

Page Page Page Page Page Page Page Page Page Page Page Page

5-1 5-3 5-4 5-4 5-5 5-6 5-8 5-9 5-9 5 - 10 5 - 11 5 - 15

Servicing the Unit

Cleaning Servicing the Battery

Page Page

6-1 6-1

Page Page Page Page Page

7-1 7-1 7-2 7-2 7-3

Checklists for Checks after Repair and Technical Safety Check (TSC)

Procedural Instructions on the TSC

Test Equipment and Special Tools

0- 4

Visual Inspection Electrical safety according to IEC / EN 60601-1 or VDE 0750 and VDE 0751 Functional Inspection

Page

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Page Page

8-2 8-5

Test equipment Special Tools

Page Page

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Table of Contents

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Spare Parts List

SpaceStation, SpaceCover, SpaceCom

Page

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Revision Documentation

Description of Version

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Index

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Table of Contents

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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 performed 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

-

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:

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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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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

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Semiconductors can be destroyed by electrostatic discharge. Especially MOS components can be damaged by interference from electrostatic fields, even without discharge via contact. This type of damage is not immediately recognizable. Unit malfunctions can even occur after a longer period of operation.

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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. 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.

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Warnings

Imminent danger which can result in death or serious injuries. ¾ Preventative measures. DANGER

Possible danger which can result in death or serious injuries. ¾ Preventative measures. WARNING

Possible danger which can result in slight injuries or material damage. ¾ Preventative measures. CAUTION

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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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

CE

Communauté Européenne

CS

Calibration Step

DIN

Deutsche Industrie Norm (German Industrial Norm)

EN

European Norm

ESD

Electrostatic Discharge

FuP

Function Microprocessor

HiBaSeD

History Barcode Service and Druglist

IEC

International Electrotechnical Commission

ISO

International Organization for Standardization,

ISP

Infusomat® Space

ISPS

Infusomat® Space (Silicon)

ISPP

Infusomat® Space, (PVC)

KuP

Monitoring Microprocessor

LCD

Liquid Crystal Display

MOS

Short name of the following company: MOS Technology, Inc. (Commodore Semiconductor Group)

PCA

Patient Controlled Analgesia

PDMS

Patient Data Management System

PSP

Perfusor® Space

SP

Space (System)

SPC

SpaceCover

SPCC

SpaceCover comfort

SPCS

SpaceCover standard

SPCO

SpaceCom

SPCT

SpaceControl

SPS

SpaceStation

SW

Software

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Important Preliminary Remarks

TS

Trouble Shooting

UTS

Unit Test Step

TSC

Technical Safety Check

TEMP

Temperature

VDE

Verband der Elektrotechnik, Elektronik und Informationstechnik e.V. (German Association of engineers)

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Contact Persons

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Technical Training

Via local representative.

Entry for Technical Training

Application for a technical training course must be made via the responsible representative.

Ordering of Spare Parts and Test Equipment

Please contact your local B. Braun subsidary. International Technicians (Intercompany) Irene Marchel Fax: +49 5661 / 75 -38 57 e-mail: [email protected]

Service Hotline

Martin Heusner Phone: Fax: e-mail:

+49 5661 / 71 - 35 25 +49 5661 / 71 - 35 26 [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. Ludwig Schütz e-mail: [email protected]

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Description

System Overview

1

The modular Space system is destined for treatment of an individual patient. It is designed for application on intensive care units and in the surgery. The Space System is operated in hospitals mainly by doctors and medically trained personnel. The SpaceStation forms together with the SpaceCover an organization system. The Space system infusion and infusion syringe pumps are attached and connected to the SpaceStation.

System Overview

The Space system is a modular design of modern infusion technology for stationary, mobile or private use. The key modules and their connections to one another and 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 for Fig. 1 - 1: Item Designation 1

SpaceCover

2

Infusion pump Infusomat® Space

3

Infusion syringe pump Perfusor® Space

4

SpaceControl

5

SpaceStation

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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 maximum total of 24 pumps. SpaceStations placed next to each other can be connected via special connecting cables, if the maximum number of 24 pumps in a maximum of 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

SpaceStation without SpaceCom The SpaceStation consists of the housing and the housing back panel.

1

2

3

4

The power supply with power connector and power socket for another SpaceStation is installed on the right side in the housing. The pumps in the SpaceStation are locked by eight locking claws which are also built in the housing as the module lock subsystem. This subsystem also contains the locking for a SpaceCover or another SpaceStation. The pump is released with a release button on the left side of the housing. The pumps are connected to the system via the connectors “F2A“ to “F2D“ (from top to bottom) which are integrated in the interface board, while the SpaceStation is connected to other modules via the connectors “F3“, “F4” and “F5”. The interface board with connectors is installed on the left side in the housing.

6

5 Fig.: 1 - 2 SpaceStation, front view Legend for Fig. 1 - 2: Item Designation 1

Pump lock

2

Connector “F5“

3

Module lock

4

Connector “F1B“ (mains output)

5

Tube guide

6

Connector “F2D“

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System Overview

1

Four tube guides are clipped in on the left and right housing side. 2

A pole clamp guide for attachment and locking of the pole clamp is located at the housing back panel.

1

5

4

3

Fig.: 1 - 3 SpaceStation without SpaceCom, rear view Legend for Fig. 1 - 3: Item Designation 1

Pole clamp guide

2

Release button

3

Connector “F3“

4

Connector “F4“

5

Connector “F1A“ (power input)

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System Overview

SpaceStation with SpaceCom

1

2

The physical construction of the SpaceStation housing base body with SpaceCom corresponds exactly to the physical construction of the SpaceStation without SpaceCom. The housing back panel with integrated fan, the printing of the interface symbols and the battery compartment with battery compartment cover are different. Interfaces and a status- and alarm LED are located on the righthand side behind the connector cover and the W-LAN cover. A battery pack can be inserted in the battery compartment on the rear side. The opening is covered by the battery compartment cover.

4

A fan grid with fan is fitted on the left side of the battery compartment.

3 Fig.: 1 - 4 SpaceStation with SpaceCom, rear view Legend for Fig. 1 - 4: Item Designation 1

Fan grid

2

Battery compartment with battery compartment cover

3

Connector cover

4

W-LAN cover for W-LAN module or W-LAN USB stick

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System Overview

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SpaceCover standard 1

The SpaceCover standard consists of the housing back panel and the housing bottom part and upper part. A SpaceStation can be transported with the carrying handle. SpaceCover comfort The physical construction of the SpaceCover comfort corresponds to that of the SpaceCover standard. Additionally, the following subsystems are integrated: -

The battery pack (optional) It is inserted from below in the battery compartment of the housing bottom part. The opening is covered by the battery compartment cover.

Fig.: 1 - 5 SpaceCover comfort

-

Legend for Fig. 1 - 5: Item Designation

Status and alarm indicator welded with the housing bottom part.

-

Operating and status display field at the left side of the housing upper part.

2

1

SpaceCover comfort

2

Alarm indicator

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System Overview

Function

SpaceStation without SpaceCom The SpaceStation supplies the inserted pumps as well as a SpaceControl connected to the pumps with the required voltage. The voltage is generated by the integrated power supply, which is connected to the supply mains via the connector “F1A” and a mains cable or an upstream SpaceStation. The mains voltage is transmitted via the internal cabling to connector “F1B“ for connection of a further SpaceStation. The pumps are connected with connectors “F2A” to “F2D” to the SpaceStation. These connectors provide the voltage supply, distribute the addresses in the Space system via a serial interface, transfer data via a bus system (CAN bus) and transmit a staff call, which may be pending. Another SpaceStation inserted on top or a SpaceCover is integrated in the Space system via connector "F5". Connector “F4“ is used for connecting another SpaceStation or further SpaceStation columns. An upstream SpaceStation or an upstream SpaceStation column as well as accessories that may be connected, such as a PCA button or a service connector, are connected to connector "F3".

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