Medifa 81220 User Manual Download Page 4

User manual for radiolucent arm rest version 1.0

Important information

Revision history

Version

Date

Reason for change to the publication

1.0

04/2020

First edition

1.  Important information

CE marking

This product is a class 1 medical device according to the European Directive 93/42/ EEC on medical devices. This corresponds 
to the version of this directive valid at the time it was placed on the market.

Conformity

The manufacturer declares that this product complies with the main requirements according to MDD Appendix 1. The 
manufacturer also declares that a conformity assessment procedure, according to MDD Appendix 7, (and required for Class-1 
products) was carried out and documented by a CE marking. 

Manufacturer and distributor

medifa GmbH & Co. KG
Industriestraße 5
57413 Finnentrop
Germany
Telephone: +49 2721 7177-0
Service Hotline: +49 2721 7177 410
Fax +49 2721 7177-255
[email protected]
www.medifa.com

Copyright notice

These operating instructions, including all figures, are subject to copyright. The reproduction and duplication of this docu-
ment as well as the usage and communication of its contents, are not permitted unless explicitly stated. Violators shall be 
liable to pay for damages. All rights are reserved in the event that a patent is granted or utility prototype registered. 

We are constantly working on the further development and design of our products. Please understand that we reserve the 
right to change the scope of delivery in terms of form, configuration and technology at any time. 

Reproduction, duplication or translation of the original operating instructions, in whole or in part, is not permitted without 
the written permission of medifa! 

All rights under the copyright law are expressly reserved for medifa. medifa is only responsible for the safety characteristics 
within the scope of the statutory regulations if all maintenance, servicing and changes to this device have been carried out by 
the user or a representative as instructed.

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Summary of Contents for 81220

Page 1: ...Radiolucent arm rest Art no 81220 User manual Version 1 0 ...

Page 2: ......

Page 3: ...2 Foreword 5 3 Understanding these operating instructions 6 4 Symbols in use 7 5 Safety instructions and user obligations 8 6 Proper and intended usage 9 7 Rating plate 10 8 Assembly and adjustment 11 9 Care instructions 12 10 Technical specifications 13 11 Pictograms on the transport packaging 14 12 Disposal 14 ...

Page 4: ...www medifa com Copyright notice These operating instructions including all figures are subject to copyright The reproduction and duplication of this docu ment as well as the usage and communication of its contents are not permitted unless explicitly stated Violators shall be liable to pay for damages All rights are reserved in the event that a patent is granted or utility prototype registered We a...

Page 5: ... manufacturing The medifa products are manufactured to have a long and trouble free lifespan The development design and production at medifa have been certified to comply with DIN EN ISO 9001 and DIN EN ISO 13485 These products comply with the requirements of the Medical Devices Act and bear the CE mark The product consists exclusively of high quality materials with a high service life We are alwa...

Page 6: ...use training for technical qualifications may be carried out by a qualified person The operating instructions must be closely followed and available at the place of use ATTENTION This product is safe to use Any remaining residual hazards are indicated at the affected locations in the operating instructions Follow these instructions Abbreviation Description CE European Community from the French Com...

Page 7: ...on which if not avoided will result in death or serious injury WARNING WARNING indicates a hazardous situation which if not avoided could result in death or serious injury CAUTION CAUTION indicates a hazardous situation which if not avoided could result in minor or moderate injury ATTENTION Notice about a harmful situation possible consequences the device itself or surrounding objects could be dam...

Page 8: ... cause the system to become unstable thus preventing the product from performing its protective function The product may only be mounted on standard rails with the dimensions 10x25 mm Steps to take before each use in the OP All mechanical components of the product must be checked for proper functionality and integrity before each use Do not use defective or damaged products Infection control Follo...

Page 9: ...be used and operated responsibly and in a controlled manner by trained medical and nursing staff The manufacturer of other persons authorised by the manufacturer shall carry out the training for the operating and care personnel In order to ensure proper and intended usage of the product these operating instructions for the arm rest and the X ray table must be followed Any other usage is considered...

Page 10: ...nufacturer specifications and contact information Article number Batch number QR code Date of manufacture Max load Read the operating instructions Follow the instructions for disposal This product is declared to be compliant with Directive 93 42 EEC 10 medifa GmbH Co KG Industriestraße 5 57413 Finnentrop Germany MM YYYY 81220_x xxxxx 8 ...

Page 11: ... on retainer together and hook it from top to bottom into the carbon rail at the desired position 2 Release the clip on retainer The arm rest is now firmly clamped in at the desired position 1 Pull the release ball 1 in the direction of the arrow Then turn the armrest to the desired position it is adjustable up to 180 degrees Attaching the arm rest Adjusting the arm rest Removing the arm rest 2 Re...

Page 12: ...for Applied Hygiene Clean contaminated products immediately The cleaning disinfection is limited to a regular wiping not dipping using the appropriate substance Cleaning For cleaning the plastic parts use a pH neutral or slightly alkaline all purpose cleaner with surfactants for cleaning active components If parts are heavily contaminated use concentrated cleaner and then wipe with clear water Dis...

Page 13: ...and load limits Classification Medical device class I Technical specifications Dimension Length 690 mm Wide 155 mm Upholstery height Art no 81220_1 20 mm Art no 81220_2 40 mm Art no 81220_3 60 mm Tare weight Art no 81220_1 2 kg Art no 81220_2 2 2 kg Art no 81220_3 2 4 kg Max load 8 kg 13 10 1 10 2 ...

Page 14: ...t your local dealer or the appropriate national authority The company medifa will take back old products defective devices or products no longer in use Contact medifa Technical Support for more details 12 Disposal There are several handling symbols on the transport packaging Elements symbols Description Protect the transport packaging against moisture Read the operating instructions Protect from s...

Page 15: ......

Page 16: ...medifa GmbH Co KG Industriestraße 5 57413 Finnentrop Germany fon 49 2721 7177 0 fax 49 2721 7177 255 info medifa com www medifa com ...

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