B. Braun Infusomat Compactplus P Manuel utilisateur

Infusomat® compactplus P

Service Manual EN, Version 1.0

For internal use, only

0 - 2 Infusomat®compactplus P 1.0 EN

For internal use, only

THIS SERVICE MANUAL IS VALID FOR Designation Part No.

Infusomat® compactplus P . . . . . . . . . . . . . . . . . . . . . . . . . 8717070

AVAILABILITY OF THIS SERVICE MANUAL This Service Manual can be downloaded as PDF file under the fol-

lowing document number from the B. Braun Service Portal:

Designation Doc. No.

Infusomat® compactplus P . . . . . . . . . . . . . . . . . . . . I0003_000616

Service Manual, English

LANGUAGES OF THIS SERVICE 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.

Infusomat® compactplus P . . . . . . . . . . . . . . . . . . . . I0003_000615

Service Manual, German

OTHER APPLICABLE DOCUMENTS This Service Manual is valid only in combination with the following

additional documents:

Designation Doc. No.

compactplus Service Tool (Software) . . . . . . . . . . . . IXXX2_000645

Instructions for Use, English

THE COMPLETE SERVICE MANUAL CONTAINS

THE FOLLOWING PAGES:

Page 0 - 1 to Page 0 - 16

Page 1 - 1 to Page 1 - 8

Page 2 - 1 to Page 2 - 8

Page 3 - 1 to Page 3 - 32

Page 4 - 1 to Page 4 - 14

Page 5 - 1 to Page 5 - 2

Page 6 - 1 to Page 6 - 4

Page 7 - 1 to Page 7 - 10

Page 8 - 1 to Page 8 - 2

Page 9 - 1 to Page 9 - 4

Page 10 - 1 to Page 10 - 2

Page 11 - 1 to Page 11 - 2

Infusomat® compactplus P 1.0 0 - 3

For internal use, only

Table of Contents

0 - 5 Important Preliminary Remarks

0 - 5 Service work

0 - 5 Technical safety checks

0 - 6 Current versions

0 - 6 Product availability

0 - 6 Responsibility of the manufacturer

0 - 6 Quality management

0 - 6 Technical training

0 - 7 Check after repair

0 - 7 Notes on ESD

0 - 7 Spare parts

0 - 8 Calibration of gauges

0 - 9 Measuring equipment

0 - 10 Safety data sheets

0 - 10 Setting off

0 - 11 Special PDF functions

0 - 12 List of abbreviations

0 - 15 Contact Information

0 - 15 Technical training

0 - 15 Entry for technical training

0 - 15 Ordering of spare parts and test equipment

0 - 15 Service hotline

0 - 15 Returns

0 - 15 Returns for repairs

0 - 15 Safety officer (§ 30 MPG)

0 - 15 Service portal

1 - 1 Overview of the Device

1 - 1 System overview

1 - 2 Description of device

1 - 2 Intended use

1 - 2 Device overview

1 - 2 Mechanical design

1 - 3 Function

1 - 5 Unit software

1 - 5 Service program

1 - 6 Technical data

1 - 6 Options

1 - 6 Accessories

1 - 7 Functional test

2 - 1 Unit Diagnosis / Adjustments

2 - 1 Alarms and error messages

2 - 1 Log files

2 - 1 Pre-alarms and operating alarms

2 - 2 Standard device alarms

2 - 3 Device alarms with reduced display

2 - 6 The most important fault events

2 - 7 Adjusting the mechanical pressure

3 - 1 Disassembly / Assembly

3 - 1 Remarks on disassembly

3 - 3 Remarks on assembly

3 - 4 Housing foot

3 - 5 Gasket for rubber connector

3 - 6 Membrane

3 - 7 Pole clamp

3 - 8 Battery module

3 - 10 Second clamp

3 - 11 Pump door

3 - 12 Opening/closing the unit

3 - 15 Loudspeaker

3 - 17 Processor board

3 - 18 Accessory connector

3 - 19 Display board with display

0 - 4 Infusomat®compactplus P 1.0 EN

Table of Contents

For internal use, only

3 - 20 Housing, upper part

3 - 22 Housing front

3 - 30 Pump

3 - 31 Power supply

3 - 32 Checks after Repair

4 - 1 Check after Repair

4 - 1 Check after Repair matrix

4 - 2 Pump RUN IN

4 - 4 Checklist for Check after Repair

4 - 6 Procedural instructions on the Check after Repair

5 - 1 Servicing the Unit

5 - 1 Cleaning and disinfecting

5 - 1 Servicing the battery

6 - 1 Technical Safety Check (TSC)

6 - 1 Checklist for Technical Safety Check (TSC)

7 - 1 Procedural Instructions on the TSC

7 - 1 Visual inspection

7 - 2 Electrical safety

according to IEC 62353

7 - 2 Functional inspection

8 - 1 Test Equipment and Tools

8 - 1 Test equipment

8 - 1 Standard Tools

8 - 2 Special tools

9 - 1 Spare Parts List

10 - 1 Index

11 - 1 Appendix

11 - 1 Revision documentation

11 - 1 Current information

11 - 1 History of spare parts

11 - 2 Service Report

Infusomat® compactplus P 1.0 0 - 5

For internal use, only

Important Preliminary Remarks

SERVICE WORK The present manual is for 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 technical training on the system from B. Braun

■Observe the latest information in the B. Braun Service Portal

bbraun.com/mybbraun > Service Portal (access granted in con-

nection with a technical training, only)

■Possess the necessary test equipment and special tools

■Fulfill the personal requirements (training and knowledge

including the respective standards and regulations)

TECHNICAL SAFETY CHECKS Performing the TSC is an obligation of the owner of the equipment

and is subject to the laws of the country where the equipment is

located. In countries in which a TSC is mandatory, B. Braun pre-

scribes an interval of 24 months. The owner may decide on shorter

intervals or shorter intervals may be prescribed by the law. The TSC

obligation applies independently of possible repairs.

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, a service program must be used

which may lead to a dangerous unit condition in case of inap-

propriate operation. Furthermore, a special service connector

may be necessary.

WARNING

The Infusomat® compactplus P is a life-saving device or part of a

life-saving system that, on the other hand, can pose a risk if it is

not working properly.

Danger of injury to the patient!

■Perform all service works with due care following the instruc-

tions given in this Service Manual.

NOTICE

Make sure to be familiar with the Instructions for Use.

Important Preliminary Remarks

0 - 6 Infusomat®compactplus P 1.0 EN

For internal use, only

CURRENT VERSIONS This manual version corresponds to the state when the manual was

written. B. Braun reserves the right to make technical modifica-

tions. The state of the revision is indicated by the version number

in the footer of every page.

To view the current Service Manual, please visit the Service Portal

at: bbraun.com/mybbraun > Service Portal.

Approval to use the service portal will only be granted after com-

pletion of a technical training course.

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

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

availability.

RESPONSIBILITY OF THE MANUFACTURER The manufacturer or the person who assembles, installs or imports

a device can only be held responsible for safety, reliability and per-

formance 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 IEC 60364-7-710 and applicable national

standards like VDE 0100 part 710,

■the device is used in accordance with the Instructions for Use,

■the Technical Safety Checks are performed at regular intervals

in the case TSCs are mandatory for that device,

■a current Service Manual is used when performing mainte-

nance, repair or other servicing activities,

■the technician has participated in a technical training for the

specific B. Braun device.

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

ISO 13485. This certification also includes maintenance and ser-

vice.

The device bears the CE mark. The CE mark indicates that the

device is in conformity with the provisions of the COUNCIL DIREC-

TIVE 93/42/EEC of 14 June 1993 concerning medical devices.

TECHNICAL TRAINING Technical training may only be performed by B. Braun. The posses-

sion of the Service Manual does not authorize to perform repairs.

Important Preliminary Remarks

Infusomat® compactplus P 1.0 0 - 7

For internal use, only

CHECK AFTER REPAIR The checks after repair depend on the service work performed. They

follow the Check after Repair Matrix. If several servicing activities

have been carried out, the total of all necessary tests (checks) has

to be performed.

If no Check after Repair Matrix is defined, perform the checks after

repair according to the TSC checklist as mentioned later in this

manual.

NOTES ON ESD Semiconductors can be destroyed by electrostatic discharge. Espe-

cially MOS components can be damaged by interference from elec-

trostatic 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 recommen-

dations with the necessary static protective measures, if ESD com-

ponents or boards are handled (Fig. 0 - 1).

Each workstation must be equipped with a conductive table sur-

face. 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.

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.

SPARE PARTS 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.

Fig. 0 - 1 Example of a workstation with ESD protection equipment

Important Preliminary Remarks

0 - 8 Infusomat®compactplus P 1.0 EN

For internal use, only

CALIBRATION OF GAUGES B. Braun calibration gauges are delivered with a calibration certif-

icate 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:

■If a gauge has been repaired or modified

■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.

NOTICE

The use of spare parts with a serial number or a batch number

has to be documented. Affected spare parts are specified in the

list of spare parts.

Parts with a serial number (SN) carry a sticker with the part

number and the serial number as well as a data matrix code. In

case there are several stickers on the part, the number starting

with 3452XXXX has to be used. Additionally the serial number is

on the label of the packaging.

Parts with a batch number carry the number only on the label of

the packaging (LOT).

In case a set or kit (3477XXX) contains a part with a batch num-

ber the number is on the bag containing the part.

The documentation has to be realized at least in the service re-

port (see "Service Report" ➡p. 11 - 2).

Important Preliminary Remarks

Infusomat® compactplus P 1.0 0 - 9

For internal use, only

MEASURING EQUIPMENT Additional measuring and test equipment used for servicing our

devices must comply with the following standards and/or mea-

suring equipment specifications:

Electrical safety:

IEC 60601-1, ed 3.1

EN 62353

For example, Bender UNIMET 800/810ST

bender-de.com/en

or comparable

Voltage measurement: For example, Multimeter Fluke 177

fluke.com/en-us

or comparable

Clearance measurement:

Slip gauges

According to DIN 2275, tolerance T2 or better.

For example,

wermas.de

or comparable

Pressure measurements:

Measurement accuracy ≤ 80 mbar (1.16 psi)

For example, Kobold MAN-SD1S Y A3 0

S#2062378.8 customer-specific

kobold.com/en

or Sika MH 3750

sika.net

or Fluke 717

fluke.com

or comparable

Flow accuracy:

Scales: Measurement range 220 g

Linearity deviation ±0.1 mg

Standard deviation ±0.05 mg

Readability 0.01 mg

Important Preliminary Remarks

0 - 10 Infusomat®compactplus P 1.0 EN

For internal use, only

For example, Sartorius CPA324S-OCE

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 (catalogue no: 015.01.025)

isolab.de

SAFETY DATA SHEETS The material safety data sheets for the consumables described in

this Service Manual can be requested free of charge from B. Braun.

The latest version of each document can be downloaded as a PDF

in the service portal under bbraun.com/mybbraun > Service Portal.

SETTING OFF Warnings and notes

Additional notes and warnings are set off as follows:

References

References to chapters are shown as follows

(see "Setting off" ➡p. 0 - 10)

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)

WARNING

Is used for working steps which may result in severe personal

injury or, in extreme cases, even death if instruction is not

observed.

CAUTION

Is used for working steps which may result in minor or moderate

personal injury if instruction is not observed.

NOTICE

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

without a potential risk of injuries, and is used for additional or

specific information.

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