Enraf Nonius MANUMED User manual

INSTRUCTIONS FOR USE
October 1st 2019
EN109-1400912-4E IFU
``
MANUMED

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INDEX
1. FOREWORD.........................................................................................................................3
2. SYMBOLS.............................................................................................................................4
3. INTENDED USE AND INTENDED USER ................................................................................5
4. PACKAGE CONTENTS ..........................................................................................................5
5. INSTALLATION.....................................................................................................................5
6. PRECAUTIONS.....................................................................................................................6
7. OPERATION ........................................................................................................................8
8. SAFETY INSTRUCTIONS .....................................................................................................14
9. MAINTENANCE .................................................................................................................16
10. SPECIFICATIONS ...............................................................................................................18
11. CONTACT ..........................................................................................................................21
12. PRODUCT LIABILITY .........................................................................................................21

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1. FOREWORD
We are pleased that you have purchased a Manumed treatment couch. This examination and
treatment couch is specially designed for the demands of the physical and manual therapist.
The anatomically segmented top part combined with the wide array of section positions
enable you to position your patient virtually however you wish.
During development and production of this couch a great deal of care was put into the
reliability, safety, ease of use and durability.
It is important to read the following instructions carefully before using your
Manumed treatment couch properly and safely.
Should the use of this device lead to an undesirable event such as death or
serious injury to the user, the manufacturer and the competent authority of the
Member State MUST be informed without delay!
This instructions for use applies to:
•Manumed Optimal 2- and 3-sections
•Manumed Osteo
•Manumed Comfort
•Manumed Exercise (Bobath)
•Manumed Traction

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2. SYMBOLS
Follow the instructions in the Instructions for Use.
It is important that you read, understand, and observe the
precautionary and operating instructions
Indicates a hazardous situation which, if not avoided, could result in:
a. Death or serious injury to the patient or operator (or)
b. Minor to moderate injury to the patient or operator (or)
c. Damage to the equipment
Temperature Range
Indicates acceptable temperature range
Humidity Limits
Indicates acceptable relative humidity
Atmospheric Pressure
Indicates the range of atmospheric pressure to which the medical
device can be safely exposed.
Electric waste can be reused.
Indicates the electrical and electronic components of the device that
can be recycled and must be disposed of separately.
Manufacturer name and address and production date
Reference Number or Part Number
Serial Number
Indicates the manufacturer’s serial number so that a specific medical
device can be identified.
IP 44
Ingress Protection Marking, classifies and rates the degree of
protection provided against intrusion (body parts such as hands and
fingers), dust, accidental contact, and water by mechanical casings and
electrical enclosures.
Double Insulation
Indicates manufacturer's declaration that the product meets the
requirements of the applicable EC directives
Type B applied part complying with the specified requirements to
provide protection against electric shock, particularly regarding
allowable patient leakage current and patient auxiliary current.

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Risk of crushing hands
3. INTENDED USE AND INTENDED USER
The couches are intended ONLY to be used to support patients during physical and manual
therapy.
The Manumed couches are designed to ONLY be used by or under the supervision of
competent personnel in physiotherapy, rehabilitation, or adjacent areas.
4. PACKAGE CONTENTS
•Manumed Couch
•Instructions for Use (PDF on CD) 1400912
•Information booklet 1400913
The use of accessories and cables other than those specified or supplied by the
manufacturer of this equipment is not permitted.
5. INSTALLATION
•Take the Manumed and any extra parts out of the cardboard packaging and check
everything for possible transport damage.
•Read this manual carefully before using the equipment.
•Mains supply connections must comply with the national requirements regarding medical
rooms.
•Prior to connection of this apparatus to the mains supply, check that the voltage and
frequency stated on the type plate correspond with the available mains supply.
•Avoid exposure to direct sunlight, UV radiation, rain, excessive dust, moisture, mechanical
vibrations and shocks.
DO NOT USE the device in case if you notice any damage from transport!
Please notify your supplier immediately.

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6. PRECAUTIONS
It is important to read the following instructions for use carefully before using your
Manumed properly and safely.
The manufacturer cannot be held responsible for the results of using this device
for any purposes other than described in these instructions for use.
It is important that you inspect your goods for damage when received. The device
must not be used before inspection is complete.
The Manumed is only meant to be used by competent personnel in physiotherapy,
rehabilitation or adjacent areas. Avoid any use of the equipment by unauthorized
personnel.
At all times keep children away from the equipment when no supervision is at
hand!
Use both hands to change the couch settings: one hand for unlocking and the other
to adjust the section.
Never adjust a section when it supports the full weight of the patient! Each
section of this Manumed is supported by gas springs. As well as easing operation,
they offer full support of the sections. However, these gas springs are not strong
enough to lift a section while it supports the full weight of the patient.
A maximum patient’s weight of 200 kg (250 kg optional) is allowed when the height
of the couch is being adjusted.
If the couch is equipped with an electric motor, never let the motor exceed 4
minutes continuous operation. If this should happen, a thermal cut out shuts off
the power and protects the motor against overheating. In that case, remove the
mains cable and let the motor cool down until it functions again.
The couch is not anti-static.
The Manumed couches are not intended for use in so-called “wet rooms”
(hydrotherapy rooms).
Always use the original Enraf-Nonius accessories that are meant for this product.
The couch may not be used in close proximity (i.e. less than 2 meters) to shortwave
equipment
Use a clean couch cover / towel / terry cloth / paper cover for every individual.
This is required to guarantee a hygienic use.
Do not use cleaning agents that contain alcohol or other aggressive cleaners.
It is MANDATORY to have the Manumed checked annually by authorized personnel
of Enraf-Nonius or by its authorized distributor.
Never let your full weight rest on the switch bar!
Ensure that you will never rest your feet on the all-around-operation.
Especially when seated next to the couch it can lead to a dangerous situation in
which your leg can be jammed between the section and the all-around-operation.
Do not sit on the head and leg section of the couch (danger of tilting at approx. 80
kg).

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Head section: is not suited to sit upon and must be used to support the head
only.
Arm supports: are not suited to sit upon and must be used to support the arms
only.
When adjusting this couch, keep hands away from the couch for at least 20 cm,
especially on places that have been marked by the hand crush warning symbol.
The maximum traction force with the Manumed Special Traction (type 004, 916
and 926) is 900 N (90 kg).

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7. OPERATION
The operation of your Manumed treatment couch is simple and safe. The illustrations show
how the various adjustments are done
MOVING THE COUCH
The couch can be moved by using the foot pedal to
lower the wheels.
NOTE: Never move the couch with a person or load
on it. Move the couch only on a smooth surface.
The couch is not designed to move across
thresholds.
ADJUSTMENT TO THE FLEXION POSITION
Use one hand to unlock the couch section locks
while setting the tops into position with the other
hand. The flexion setting is made easier by gas
springs.
HYDRAULIC HEIGHT ADJUSTMENT
The required height can be reached by pressing
and releasing the pedal repeatedly. The couch can
be lowered by lifting the pedal with the foot.
ELECTRIC HEIGHT ADJUSTMENT
By pressing the foot switch continuously, the
required height can be reached.

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TREATMENT TABLE WITH ELECTRICAL DRAINAGE
AND TRENDELENBURG POSITION
This table takes over some tilting tasks from you,
even with a patient lying on it, e.g. in situations
like:
Drainage up: press 1: table switch ▲.
Drainage down: press 2: table switch ▼.
Trendelenburg up:
press 1: table switch ▲, and pull 3: use one
hand to unlock the leg section lock,
while adjusting the section upward
with the other hand.
Trendelenburg down:
pull 3: use one hand to unlock the leg section lock,
while adjusting the section downward with the
other hand, and
press 2: table switch ▼
ADJUSTMENT OF ROLLING TOP SECTION (TYPE
916 -926)
By operating the handle, the rolling top section can
be release for traction and locked after traction
ADJUSTING THE BACK SECTION
Pull the handle underneath the back section and
adjust the section with the other hand in the
desired position.

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ADJUSTING THE HEAD AND LEG SECTIONS
Pull the handle underneath one of the leg sections
and adjust the leg section with the other hand in
the desired position.
Head section: pull the handle underneath the
head section and adjust the head
section in the desired position.
Leg section: pull the handle underneath the leg
section and adjust the leg section in
the desired position.
Use one hand to unlock the couch section lock,
while adjusting the section with the other hand.
The handle to unlock the head section is situated
underneath the head section itself.
Be sure that the armrests (optional) are slide
upwards in case the head section is rotated
downwards more than 40 degrees.
Manumed type 400
Manumed type 200

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ADJUSTMENT OF THE HORIZONTAL POSITION ON
THE MANUMED OSTEO
The Manumed Osteo with electric section
adjustment are fitted with programmable
operating buttons.
A. Use the electric operation A and B to adjust the
sections up and down independently.
The positions of the back-section and the
sitting-section are programmable. Press
buttons 3 and 4 (both buttons from B) in order
to recall the programmed position
B. Reprogramming the positions of the back-
section and the sitting-section
a. Adjust the sections to the desired position.
b. Press keys 1 and 2 simultaneously
c. Confirm the settings by pressing key 3 and
4 within 2 seconds. The new settings are
acknowledged with a beep.
A = electric operation back-section
B = electric operation sitting-section
1 = back-section up
2 = back-section down
3 = sitting-section up
4 = sitting-section down
ADJUSTMENT OF THE ARM COUCH SECTIONS
The arm sections can be adjusted for height by
loosening the knob and sliding the arm sections
along the runners.

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HOW TO REMOVE THE UNLOCK-BUTTON OF
THE MANUMED OSTEO
Your Manumed Osteo is provided with the
unlock-button on the head-section, it can be
removed as follows:
•Adjust the head-section in a horizontal
position
•Remove the unlock-button by pulling it out
•The unlock-button can now be removed from
the couch
For safety-reasons, the unlock-button can only
be removed when the head-section is in
horizontal position.
HEIGHT ADJUSTMENT WITH THE CIRCULAR
SWITCH BAR.
By pressing the circular switch bar - which is
located underneath the framework - up or down
with your foot, the required height of the couch
can be set.
Never let your full weight rest on the
switch bar!
CHANGING THE HEIGHT OF THE CIRCULAR
SWITCH BAR.
The circular switch bar can be mounted at 2
different heights. In case you want to change the
heights of the bars than dismount both bars
(with the 6 mm hexagonal screws). Now mount
the left bar upside down at the right side and the
right-side bar upside down at the left side.
See below for a graphic reproduction

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Changing the height of the circular switch bar:

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8. SAFETY INSTRUCTIONS
HEIGHT ADJUSTMENT (GENERAL)
Ensure that neither the patient nor the
operator can get any part of the body or
clothes near or in between the moving
parts of the mechanism when the couch
is being raised or lowered.
Be particularly careful for those situations
indicated below (the couch is set in
flexion position combined with the lowest
possible position):
a) Underneath the head section,
between the head section and floor.
b) Underneath the leg section, between
the leg section and framework.
c) Under the couch adjustment bars
(therapist’s feet). These situations
occur only when the couch is
adjusted to the lowest possible
position.
HEIGHT ADJUSTMENT
Ensure that you will never rest your
feet on the all-around-operation.
Especially when seated next to the
couch it can lead to a dangerous
situation in which your leg can be
jammed between the section and
the all-around-operation.

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HEIGHT ADJUSTMENT (HEAD SECTION
WITH ARM SUPPORTS)
If the couch is equipped with a head
section with arm supports, it is not
possible to completely lower the back
section (flexion position).
DANGER OF TILTING
Do not sit on the head and leg
section of the couch (danger of
tilting at approx. 80 kg).
LOAD
Head section: is not suited to sit upon and must be used to support the head only.
Arm supports: are not suited to sit upon and must be used to support the arms only.
RISK OF CRUSHING HANDS
On this couch a warning sticker is placed.
When adjusting this couch, keep
hands away from the couch for at
least 20 cm, especially on places
that have been marked by the
hand crush warning symbol.
FIX ROLLING TOP SECTION
Fix all rolling top sections of the Manumed Special Traction (type 004, 916 and 926) when
the couch is not actually used for traction treatment (for example in case a client is entering
or getting off the couch)
TRACTION ONLY IN HORIZONTAL POSITION
Traction should only be realised with all top sections of the Manumed Special Traction (type
004, 916 and 926) in horizontal position.
TRACTION AT 900 NMAXIMUM
The maximum traction force with the Manumed Special Traction (type 004, 916 and
926) is 900 N (90 kg).

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9. MAINTENANCE
!!! IMPORTANT !!!
It is very important for the life of the upholstery that it is properly cleaned.
Skin oils, perspiration, make-up products, hairspray, etc. and overly aggressive detergents and
disinfectants can have a very detrimental effect on the lifespan of the upholstery.
CLEANING
•The couch must be cleaned before it is first used and before it is disinfected.
•Clean the couch with a damp cloth.
•Use a mild detergent to clean the surface.
•Remove soap residue with a damp cloth and clean water.
Do not use agents that contain alcohol or other aggressive cleaners.
DISINFECTION
•Clean the couch as described above before proceeding to disinfect the couch.
•Follow the disinfectant's instructions for use.
•Never use a mixture of disinfectants or a disinfectant and soap mixture.
•Preferably use a cloth to apply the agent to the imitation leather.
•Avoid water accumulation in the hinge points of the metal frame. (In the worst case,
exposing the hinges to water in the long-term can result in rust formation)
•The disinfectants listed on the information sheet, are tested and safe for use on the
imitation leather of the treatment table. For the most current version of the list see
http://www.enraf-nonius.com/downloads
Remarks:
•Since we have no control over the production and raw materials used for the
disinfectants, we are unable to give a general guarantee that these agents will not
damage the upholstery.

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TROUBLESHOOTING
If you encounter any problem with the Manumed, stop using the couch and contact your
supplier.
MAINTENANCE
•Check the operation of every section adjustment regularly (at least once every month).
For correct operation keep the bars of the mechanism clean and free of grease.
•Check at least once every 6 months the functioning of the height adjustment if this has
not been used for a long time.
•Disconnect the mains cable from the electricity supply if the couch is not being used for
a long period.
EXPECTED SERVICE LIFETIME
Provided the annual maintenance is carried out by a qualified Enraf-Nonius service
technician or by an official distributor as described in the service manual, and the
maintenance technician is of the opinion that the couch is suitable for use according to the
specifications, the Manumed will remain suitable for its intended use.
END OF SERVICE LIFE
The Manumed contains materials that can be reused and/or are harmful to the environment.
Make sure you are familiar with local rules and regulations regarding the
disposal of equipment and accessories.
It is mandatory to have the couch checked annually by authorized personnel of Enraf-
Nonius or by its authorized distributor.

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10. SPECIFICATIONS
TECHNICAL DATA
Mains voltage:
230V ˜
Frequency:
50/60 Hz
Duration of continues operation
short-time operation, 4 minutes
maximum.
Moisture resistance
according IP 44
Type
Hydraulic high-low
Electric high-low
Fixed height
separate arm sections
separate leg sections
flexion position
table top size (cm)
height adjustment (cm)
lifting capacity
Max current consumption
212
Optimal 3-section
x
204 x 67/57/80
47 - 97
200 kg
222
Optimal 3-section
x
204 x 67/57/80
47 - 100
200 kg
2,0 A
213
Optimal 3-section
x
x
204 x 67/57/80
47 - 97
200 kg
243
Optimal 3-section
x
x
204 x 67/57/80
47 - 100
200 kg
2,0 A
214
Optimal 3-section
x
x
204 x 67/57/80
47 - 97
200 kg
224
Optimal 3-section
x
x
204 x 67/57/80
47 - 100
200 kg
2,0 A
215
Optimal 3-section
x
x
x
204 x 67/57/80
47 - 97
200 kg
245
Optimal 3-section
x
x
x
204 x 67/57/80
47 - 100
200 kg
2,0 A
311
Optimal 2-section
x
201 x 67/57/80
47 - 97
200 kg
312
Optimal 2-section
x
201x67
45 –95
200 kg
321
Optimal 2-section
x
201 x 67/57/80
47 –100
200 kg
2,0 A
322
Optimal 2-section
x
201x67
45 –98
200 kg
2,0 A
313
Optimal 2-section
x
x
201 x 67/57/80
47 - 97
200 kg
323
Optimal 2-section
x
x
201 x 67/57/80
47 - 100
200 kg
2,0 A

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Type
Hydraulic high-low
Electric high-low
Fixed height
separate arm sections
separate leg sections
flexion position
table top size (cm)
height adjustment (cm)
lifting capacity
Max current consumption
446
Osteo 4-section
3 motors
x
x
214 x 67
51 - 103
200 kg
2,0 A
448
Osteo 6-section
3 motors
x
x
x
214 x 67
51 - 103
200 kg
2,0 A
449
Osteo 7-section
3 motors
x
x
x
x
214 x 67
51 - 103
200 kg
2,0 A
612
Comfort 3-section
x
200 x 67
46- 96
200 kg
622
Comfort 3-section
x
200 x 67
46 - 99
200 kg
2,0 A
632
Comfort 3-section
x
200 x 67
46 - 99
200 kg
2,0 A
613
Comfort 3-section
x
x
200 x 67
46 - 96
200 kg
623
Comfort 3-section
x
x
200 x 67
46 - 99
200 kg
2,0 A
511
Exercise 2-section
x
203 x 120
44 - 94
200 kg
521
Exercise 2-section
x
203 x 120
44 - 97
250 kg
2,0 A
500
Exercise fixed height
x
100 x 200
55
135 kg
510
Exercise 1-section
x
100/120 x 200
44 - 94
200 kg
520
Exercise 1-section
x
100/120 x 200
44 - 97
250 kg
2,0 A
004
Traction fixed height
x
195 x 67
83
135 kg
916
Traction 4-section
x
203 x 67
45 - 95
200 kg
926
Traction 4-section
x
203 x 67
45 - 95
200 kg
2,0 A
Technical modifications reserved!

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SAFETY AND PERFORMANCE STANDARDS
Medical device classification
I
Safety class according to IEC 60601-1
II, Double insulated,
Type B Applied part
This equipment complies with all requirements of the Medical Device Directive
(93/42/EEC).
ORDERING INFORMATION
For the ordering data of the Manumed, standard accessories and additional accessories we
refer to http://www.enraf-nonius.com
ENVIRONMENT CONDITIONS
Environment conditions for Transport and Storage
Environment temperature:
-10 to +50 °C
Relative humidity:
20 to 90%
Atmospheric pressure:
800 to 1060 hPa
Environment conditions normal use
Environment temperature:
10° to 40° C
Relative humidity:
30 to 70 %
Atmospheric pressure:
700 to 1060 hPa