Medifa 3000 User manual

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. [phone]
Service Hotline: [phone]
Fax [phone]
[e-mail]
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
q
w
e
r
Fig. 1: Model 111419/ 111519
q
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u
r
t
y
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

11
8.1
q
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8.2
q
q
Fig. 6: Floor leveling screws 111519 /171519
8.3
Fig. 4: Headrest adjustment
Fig. 5: Castors 111519F / 171519
q
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e
User manual for examination couches version 2.0
To adjust the angle of the headrest [1], it only needs to be
lifted. To lower the head section, it must first be raised to
the stop. This disengages the adjustment grid [2] and the
head section can be lowered without difficulty.
Headrest adjustment
8. Commissioning
Mobility (111519F / 171519F)
The examination couch is equipped with four castors
instead of the feet. There are two castors[1] diagonally
to each other, which can be locked. If the rocker switch of
the castor is operated, the castor is locked.
Furthermore, the examination couch is equipped with a
castor[2] which is directionally stable. If the rocker switch
is actuated via this castor, the castor no longer changes
direction and is therefore stable to move.
The last castor[3] on the examination couch is free-run-
ning.
The examination couch is additionally equipped with
ground levelling screws [1] to avoid the danger of tipping
over on an uneven surface. If necessary, turn the corre-
sponding compensating screws a little into or out of the
foot of the examination couch.
Floor leveling screws (111519 / 171519)
Commissioning

12
8.4
8.5
q
q
Fig. 8: Upholstery
User manual for examination couches version 2.0
Fig. 7: Mounting the paper roll
Attaching a paper roll
Upholstery
The upholtery[1] of the examination couches consist of a
stable carrier plate glued with foam. This is seamlessly co-
vered with a hard-wearing, tear-resistant artificial leather
suitable for medical use.
To attach a paper roll, take the supplied paper roll holder
stick [1] and push it through the paper roll.
Afterwards the roll can easily be hooked in between the
pair of legs at the head end or foot end with the stick
in the middle.To do this, drill holes are provided on both
sides in the examination couch feet available.
Commissioning

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9.2
9.1
9.3
9.4
User manual for examination couches version 2.0
9. Care instructions
Care instructions
CAUTION
Danger of personal injury.
• Only hand over cleaned and disinfected devices / equipment to a service technician for maintenance and repair work.
• Replace padding that no longer meets the hygiene and infection prevention requirements.
WARNING
Risk of damage to property due to incorrect care.
The product is not suitable for a mechanical cleaning process.
Avoid excessive distribution / application of water on the surfaces of the product.
Incorrect care products damage the surface.
For the care of the product, do not generally use abrasive cleaning and disinfecting agents containing halide and
peracetic acid. For plastic parts and padding, do not use any alcoholic and solvent-based (flammable) cleaning and
disinfecting agents.
The care products for cleaning and disinfection must comply with the nationally valid regulations for the medical sector
and/or be included in the list of the German Society for Hygiene and Microbiology / Verbund für Angewandte Hygiene e.V.
(Association for Applied Hygiene).
Clean contaminated products immediately. Cleaning / disinfection is limited to regular wiping (not immersing) with suitable
agents.
Cleaning
For cleaning stainless steel and plastic parts, use a pH-neutral or slightly alkaline all-purpose cleaner with surfactants as
active cleaning components.
In case of heavy contamination, use the cleaner in concentrated form and subsequently wipe it off with clear water.
Disinfection
For disinfection, follow the application instructions of the disinfectant manufacturer.
Alcohol- or aldehyde-based surface disinfectants are suitable for disinfecting the stainless steel parts. Only use aldehyde-
based surface disinfectants for plastic parts and padding, as alcohol-based agents can damage the surface.
Drying
After cleaning and disinfection, remove excess moisture with a dry cloth.
Disposal
Dispose of all cleaning and disinfectant residues or remnants in a harmless and environmentally friendly manner.

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10.1
User manual for examination couches version 2.0
Technical data
10. Technical data
Model Length
[mm]
Width
[mm]
Height
[mm]
Headrest
adjustment
Upholstery
thickness [mm]
Weight
[kg]
Maximum
load Castors
111419 1950 650 650 + 35° 50 35 225 kg No
111519 1950 650 650 + 35° 70 35 225 kg No
111519F 1950 650 650 + 35° 70 38 225 kg Yes
171519 1950 650 650 + 35° 70 35 225 kg No
171519F 1950 650 650 + 35° 70 38 225 kg Yes
Dimensions and adjustment ranges
Examination couche, accessories and packaging must be recycled in an environmentally friendly manner. The disposal, even
of individual parts, must always be carried out in an environmentally friendly manner, i.e. in accordance with the valid legal
regulations.
For proper disposal of old devices, please contact medifa‘s Technical customer service department, your local dealer or the
appropriate national authority.
The medifa company takes back old devices, defective or no longer used products. For detailed information, please contact
medifa‘s technical customer service department.
11. Disposal

15User manual for examination couches version 2.0

medifa GmbH & Co. KG
Industriestraße 5
57413 Finnentrop
Germany
fon [phone]
fax [phone]
[e-mail]
www.medifa.com