bbraun Infusomat Compactplus P - Current Versions; Product Availability; Manufacturers Responsibility; Quality Management

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Important Preliminary Remarks

0 - 6 Infusomat® compact

plus

P 1.0

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.