Medifa 81220 User manual

Radiolucent arm rest
Art.-no. 81220
User manual
Version: 1.0

Table of contents
Table of contents
User manual for radiolucent arm rest version 1.0
1. Important information......................................................................................................................................4
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

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: [phone]
Service Hotline: [phone]
Fax [phone]
[e-mail]
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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User manual for radiolucent arm rest version 1.0
2. Foreword
Foreword
The company medifa thanks you for purchasing the product. The arm rest is a product that combines design, functionality
and comfort with the highest quality associated with German 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 always available to help if you have any questions.
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User manual for radiolucent arm rest version 1.0
Understanding these operating instructions
3. Understanding these operating instructions
ATTENTION
Please read and observe these operating instructions.
This operating instructions must have been read and understood fully by the operating personnel before initially commis-
sioning the product, this applies particularly to the chapter Safety instructions and user obligations. If necessary, in-house
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 “Communauté Européenne”)
DIN German Institute for Standardization
EN European Standard
EEC European Economic Community
MDD Medical Device Directive
ISO International Organization for Standardization
OP Operations (surgery)
List of abbreviations
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User manual for radiolucent arm rest version 1.0
These operating instructions use various warning, notice and safety symbols to highlight information of particular relevance.
Safety instructions
DANGER
DANGER indicates a hazardous situation 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 damaged.
Symbols in use
4. Symbols in use
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User manual for radiolucent arm rest version 1.0
Safety instructions and user obligations
5. Safety instructions and user obligations
Keep these operating instructions close to the product so that the information can be accessed later! These operating
instructions are an integral part of the product and must be transferred when the location or personnel changes. These oper-
ating instructions must also be easily accessible to all users of the product at all times.
General safety instructions
WARNING
Danger for the patient!
Do not change this medical product! The manufacturer assumes no liability resulting from changes made.
• All work with or on the product (installation, commissioning, operation, maintenance, decommissioning, transport or
disposal) may only be carried out by trained medical or nursing staff.
• The product must only be used for the purposes specified in the Proper and intended usage!
• The values specified in Technical specifications must be complied with whenever the product is being used.
• The arm rest must be attached correctly according to the assembly instructions. Failure to follow the instructions may
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
• Follow all regulations for cleaning and disinfection!
• Follow the cleaning and disinfection procedures described in these operating instructions!
• Only cleaned and disinfected devices and equipment may be handed over to a service technician or the manufacturer for
repair work!
Maintenance and repair
The product is maintenance-free.
Wear caused by use as well as ageing can affect the safety relevant functions of the product. Check the condition of the
product before each use. The product must no longer be used if damage has been identified.
Repairs
Repairs may only be carried out by the medifa technical support or by personnel who have been authorized, trained and cer-
tified by medifa.The company medifa is not liable for any damages due to neglected inspections, inadequate repair, improper
maintenance or changes made to the product!
For servicing work, please contact the medifa technical support department.
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User manual for radiolucent arm rest version 1.0
This product is an arm rest. It is an accessory of the medifa 8000.
The medifa 8000 and the standard accessories are intended exclusively for human medical purposes.
The product is intended for supporting and positioning the patient’s arm immediately before, during and after performing
surgery as well as for examination and treatment.
The product may only 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 improper and unintended! The supplier/manufacturer is not liable for
personal injury or property damage as a result of improper operations or usage.
Proper and intended usage
6. Proper and intended usage
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User manual for radiolucent arm rest version 1.0
7. Rating plate
Rating plate
Fig. 1: Ratings plate 81220_x
Elements / symbols Description
Manufacturer 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
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User manual for radiolucent arm rest version 1.0
Assembly and adjustment
8. Assembly and adjustment
Make sure that all parts of the product are mechanically in order. The plastic parts must not have sharp edges or any kind of
damage.
Inspection of the product for damage
1. Press the clip-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. Remove the arm rest upwards.1. Press the clip-on retainer together.
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User manual for radiolucent arm rest version 1.0
CAUTION
Risk of personal injury!
Only cleaned and disinfected products and devices may be handed over to a service technician for maintenance and repair
work!
ATTENTION
Danger: incorrect care may damage property!
• Improper cleaning products can damage the surface!
• When cleaning the product, do not use scouring cleansers or detergents and disinfectants containing halide or peracetic
acid.
• For the plastic parts, do not use alcoholic or solvent-based (flammable) cleaning/disinfecting agents!
The cleaning products for the cleaning and disinfection must comply with the applicable national regulations for the medical
sector and/or be listed by the German Society for Hygiene and Microbiology / Association 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.
Disinfecting
For disinfecting, follow the instructions of the disinfectant manufacturer!
Surface disinfectants based on alcohol or aldehyde are suitable for disinfecting the stainless steel parts. For the plastic parts,
only use aldehyde-based surface disinfectants. Alcohol-based agents can damage the surface.
Drying
After cleaning and disinfecting, remove excess moisture with a dry cloth.
Disposal
Dispose of all cleaning and disinfectant residues in a proper and environmentally friendly manner!
Care instructions
9. Care instructions
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User manual for radiolucent arm rest version 1.0
10. Technical specifications
Dimensions, weights 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
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User manual for radiolucent arm rest version 1.0
Pictograms on the transport packaging and disposal
The arm rest and packaging must be recycled in an environmentally friendly manner. The disposal of individual parts must
also be carried out in an environmentally friendly manner (i.e. according to the relevant legal regulations)!
For more information about the proper disposal of used products, please contact medifa Technical Support, 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 sunlight.
Date of manufacture
Follow the instructions for disposal.
QR code
ATTENTION
Danger of damage to property
The packaging is not weatherproof! Please observe the storage instructions.
11. Pictograms on the transport packaging
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medifa GmbH & Co. KG
Industriestraße 5
57413 Finnentrop
Germany
fon [phone]
fax [phone]
[e-mail]
www.medifa.com