Medifa 3000 Manual de usuario
medifa 3000
Examination couches
User manual
Version: 2.0
Table of contents
Table of contents
User manual for examination couches version 2.0
1. Important information......................................................................................................................................4
2. Foreword.................................................................................................................................................................5
3. Used symbols........................................................................................................................................................6
4. Safety instructions ..............................................................................................................................................7
5. Intended use..........................................................................................................................................................8
6. medifa 3000 examination couches...............................................................................................................9
7. Rating plate............................................................................................................................................................10
8. Commissioning ....................................................................................................................................................11
9. Care instructions..................................................................................................................................................13
10. Technical data.......................................................................................................................................................14
11. Disposal...................................................................................................................................................................14
4
1.1
1.2
1.3
1.4
1.5
User manual for examination couches version 2.0
Important information
Revision history
Version Date Reason or modification of publication
1.0 02/2010 Erstausgabe
2.0 06/2020 Layout
1. Important information
CE label
This product is a Class 1 medical product according to the European Directive 93/42/EEC on medical products. It complies
with the version of this Directive applicable at the time of being placed on the market.
Conformity
The manufacturer shall declare the conformity of this product with the essential requirements as per the Medical Device
Directive (MDD) according to annex 1 as well as the execution of a conformity assessment procedure required for Class 1
products as per MDD according to annex 7 and shall document this through the CE label.
Manufacturer and distributor
medifa GmbH & Co. KG
Industriestraße 5
57413 Finnentrop
Germany
Telephone no. +49 2721 7177-0
Service Hotline: +49 2721 7177 410
Fax +49 2721 7177-255
info@medifa.com
www.medifa.com
Copyright statement
This user manual including all figures is subject to copyright. The transmission and reproduction of this document as well as
the exploitation and communication of its contents are - unless expressly permitted - are prohibited. Contraventions shall
impose and obligation to compensation for damages. All rights reserved in case of a patent grant or utility model registration.
We are constantly working on the further development of our products. Please understand that we must reserve the right to
change the scope of delivery in shape, equipment and technology at any time.
Reproduction, duplication or translation of the original user manual, even in part, is not permitted without written consent
from medifa.
All rights according to the copyright law are expressly reserved by medifa. medifa shall only be responsible for the safety-
related properties of this device within the framework of the legal regulations if maintenance, servicing and changes to this
device are carried out by medifa itself or a representative in accordance with instructions.
5User manual for examination couches version 2.0
2. Foreword
Foreword
medifa would like to thank you for purchasing the examination couche. With the examination couche, you have acquired a
product that combines design, functionality and comfort in the highest possible quality „Made in Germany“.
medifa‘s products are manufactured for a long and trouble-free service life.
Development, design and production at medifa have been certified according to DIN EN ISO 9001 and DIN EN ISO 13485.
The products comply with the requirements of the German Medical Products Act (MPG) and bear the CE label.
The examination couche consists exclusively of high-quality materials with a long service life.
medifa offers a wide range of accessories to meet your requirements. Periodic maintenance by our trained service technicians
also ensures that the table is always in perfect condition during the routine operation.
Should you have any further questions, please do not hesitate to contact us at any time.
6User manual for examination couches version 2.0
Various information and safety symbols are used in these operating instructions to highlight particularly relevant
information.
Safety instructions
HAZARD
HAZARD indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
WARNING
WARNUNG verweist auf eine potenzielle Gefahrensituation die, wenn sie nicht vermieden wird, zum Tode oder zu schwe-
ren Verletzungen führen kann.
CAUTION
CAUTION indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.
ATTENTION
Indication of harmful situation with the possible consequences: the device or something in its vicinity could be damaged.
Used symbols
3. Used symbols
7User manual for examination couches version 2.0
Safety instructions
WARNING
Risk of injury!
The examination couch is designed for a maximum load of 225 kg. This safe working load must not be exceeded.
WARNING
Risk of injury!
Only accessories listed in the accessories list may be used.
WARNING
risk of tipping!
The examination couch must not be operated over an uneven floor!
CAUTION
Danger of personal injury by tilting the examination couch!
• When driving over thresholds, the examination couch can tip over.
• The crossing of thresholds must always be carried out with two persons.
CAUTION
Danger of collision!
Take special care when transporting the examination couch.
• Familiarize yourself with the handling features before transporting a patient for the first time.
CAUTION
Patient hazard!
It is forbidden to brake the examination couch while driving! Stop the examination couch first.
4. Safety instructions
8User manual for examination couches version 2.0
The examination couch is intended exclusively for human medical purposes.
The examination couch in combination with the standard medifa accessories is intended for the following uses:
• The examination couch serves exclusively for short-term positioning of the patient during the examination and/or
treatment.
• The storage has to be carried out in a lying position.
Due to the construction of the couch, the patient can lie on his stomach or on his back.
The patient ascent or patient placement must be laterally central.The adjustable segments of the couch are
adjusted manually.
The positioning of the patient on the examination couch is done according to general practice and doctrine.
The examination couch must be covered with sterile material before use. The transport of objects, equipment or materials
on the examination couch is prohibited. The product may only be used / operated by trained medical and nursing staff in a
responsible and controlled manner.
The instruction of the operating and nursing personnel is carried out by the manufacturer or by other persons appointed by
the Manufacturer authorized persons.
For the intended use of the examination couch this instruction manual must be observed!
Any other use of the couch is considered as not in accordance with the intended purpose!
The supplier/manufacturer is not liable for personal injury or damage to property as a result of improper operation or use.
Intended use
5. Intended use
9
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Fig. 1: Model 111419/ 111519
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Fig. 2: Model 111519/171519F
User manual for examination couches version 2.0
6. medifa 3000 examination couches
medifa 3000 examination couches
No. Description
1 Upholstery
2 Safety spacer
3 Paper roll holder stick
4 Adjustable latch on the headrest
5 Holder for paper roll holding stick
6 Rocker switch for parking brake
7 Castor
10
medifa GmbH & Co. KG
Industriestraße 5 , 57413 Finnentrop, Germany
medifa 3000 11xxxx
xxxxx
Tare weight:
Max. load:
xx kg
225 kg
Manufactured: MM/YYYY
Fig. 3: Rating plate
User manual for examination couches version 2.0
7. Rating plate
Elements / symbols Description
Manufacturer details and contact information
REF Product name / type
LOT Batch number
QR Code
Manufactured Production period
Details of unladen weight and maximum additional load
Tare weight Unladen weight
Max. Load Maximum weight including accessories and patient
Observe the safety instructions in the accompanying documents
Read the user manual
Observe instructions for disposal
Device is declared compliant with Directive 93/42/EEC
Rating plate
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