Enraf-Nonius CD-ROM ManuMax Examination & Multi User manual
- Type
- User manual
Page 1 of 20 EN109-1570750-40 IFU
MANUMAX
EN109-1570750-40 IFU
November 7, 2018
Instructions For Use
Page 2 of 20 EN109-1570750-40 IFU
Table of Contents
1 Introduction ...................................................................................................................................................... 3
2 Symbols .............................................................................................................................................................. 4
3 Package Contents ........................................................................................................................................... 5
4 Installation ......................................................................................................................................................... 6
5 Intended use and intended user ............................................................................................................... 8
6 Precautions ........................................................................................................................................................ 9
7 Operation ........................................................................................................................................................ 12
8 Maintenance .................................................................................................................................................. 15
9 Specifications ................................................................................................................................................. 17
10 Contact ............................................................................................................................................................. 18
11 Product liability ............................................................................................................................................. 18
Page 3 of 20 EN109-1570750-40 IFU
1 Introduction
Thank you for purchasing the Enraf-Nonius ManuMax.
The ManuMax examination and treatment couches are intended to support a patient in the desired
position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
We hope that this is a valuable tool in the exercise of your profession, and that it will improve the
health and quality of life of many people.
This Instructions For Use relates to the ManuMax Examination 2.2, the ManuMax Multi 3.3 and the
ManuMax Multi 3.5.
It is important to read the following instructions carefully before using your ManuMax
properly and safely. The manufacturer cannot be held responsible for the results of using
this device for any purposes other than described in these operating instructions.
If the use of this device may have caused or contributed 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 notified immediately!
Page 4 of 20 EN109-1570750-40 IFU
2 Symbols
Follow the instructions in the manual.
It is important that you carefully read and apply the preventive safety and
operating instructions.
Warning or caution!:
Indicates a hazardous situation which, if not avoided, may result in
a. Death or serious injury of the patient (or)
b. Minor to medium injury to the patient (or)
c. Damage to the equipment
Temperature limits
Indicates the permissible temperature range
Humidity limits
Indicates the permissible relative humidity range
Atmospheric pressure limits
Indicates the air pressure to which the medical equipment can be safely
exposed
Waste electrical items that can be recycled.
Indicates the electrical and electronic components of the device can be
recycled and has to be disposed separately.
Manufacturer name, address and date of manufacture.
Reference Number or Part Number
Serial Number
Indicates the serial number so that a specific medical device can be identified.
IP X1
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.
“X1” indicates device protection against dripping water.
Double insulation
Product is in conformity with European Council of Medical Device Directive
(93/42/EEC)
Risk of crushing hands
Do not sit on the head section of the couch.
Page 5 of 20 EN109-1570750-40 IFU
3 Package Contents
The following is included with your treatment couch:
1x 1570750 ManuMax User Manual (PDF on CD)
1x 1570751 ManuMax Information Booklet
The use of accessories and cables other than those specified or supplied by the manufacturer
of this equipment is not permitted.
Page 6 of 20 EN109-1570750-40 IFU
4 Installation
Unpacking
Inspection
Installation
Place the ManuMax on a flat surface.
Push the lever up to put the couch back on its legs before using/applying a load to the couch.
Connect the couch to the mains using the power cord.
An audible beep will sound.
A digital lock is standard on the couch.
Enabling the digital lock will ensure the couch's motors cannot be operated. This will prevent the
couch from being adjusted unintentionally.
The lock is now enabled. Press both buttons ▲ and ▼ on the foot end of the couch for 2 seconds to
disable the lock. (also see the chapter 'Operation')
Use the all-around control (or an optional other control element) to move the couch up or down (also
see the chapter 'Operation').
The couch weighs approximately 100 kg and must be unpacked by at least two people.
Do not lift the couch by the table top parts or the all-around control.
Immediately after unpacking the couch, check whether the package contains all the items
listed above, and check the couch for any damage.
In case of damage, contact your local representative. Do NOT use the equipment!
Check the technical data section to ensure that the mains voltage meets the technical
specifications of the couch.
Check the technical data to ensure that the environment meets the environmental conditions
before using the couch.
Avoid exposure to direct sunlight, UV radiation, excessive dust, moisture, vibrations and
impacts.
ManuMax treatment couches are not suitable for use in so-called ‘wet rooms’ (hydrotherapy
rooms).
Never move the couch with a person or a weight on the couch. Only move the couch on a level
surface. The couch is not suitable for riding over thresholds.
Page 7 of 20 EN109-1570750-40 IFU
Unplug the power cord from the wall socket before using the adjustable foot.
An adjustable foot is located on the inside of one of the legs. Turn the adjustable foot until it rests on
the surface and the couch is positioned in a stable manner.
Secure the adjustable foot by turning the locking nut clockwise towards the frame.
Hooks are fitted on the inside of the subframe to guide the power cord to one of the four legs. Guide
the cord to the most suitable leg (depending on where the wall socket in your treatment room is
located). Slide one of the supplied plugs over the cord. This allows the cord to be fixed to the inside of
the selected leg. This reduces the risk of the power cord becoming trapped under the leg of the couch
after moving.
For correct installation and safe use of any accessories, please refer to the document supplied with the
relevant accessories.
Page 8 of 20 EN109-1570750-40 IFU
5 Intended use and intended user
Intended Use
The ManuMax examination and treatment couches are intended to support a patient in the desired
position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
Intended User
The ManuMax treatment couches are intended to be used, and shall only be used, by or under
the supervision of professional users in physiotherapy, rehabilitation and adjacent areas.
Page 9 of 20 EN109-1570750-40 IFU
6 Precautions
It is important to read the following instructions carefully before using your ManuMax
properly and safely. The manufacturer cannot be held responsible for the results of using
this device for any purposes other than described in these operating instructions.
If the use of this device may have caused or contributed 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 notified immediately!
The use of accessories and cables other than those specified or supplied by the manufacturer
of this equipment is not permitted.
The couch weighs approximately 100 kg and must be unpacked by at least two people.
Do not lift the couch by the table top sections or the all-around control.
Immediately after unpacking the couch, check whether the package contains all the items
listed above, and check the couch for any damage.
In case of damage, contact your local representative. Do NOT use the equipment!
Check the technical data section to ensure that the mains voltage meets the technical
specifications of the couch.
Check the technical data to ensure that the environment meets the environmental conditions
before using the couch.
Avoid exposure to direct sunlight, UV radiation, excessive dust, moisture, vibrations and
impacts.
ManuMax treatment couches are not suitable for use in so-called ‘wet rooms’ (hydrotherapy
rooms).
Never move the couch with a person or a weight on the couch. Only move the couch on a level
surface. The couch is not suitable for riding over thresholds.
The ManuMax treatment couches are intended to be used, and shall only be used, by or under
the supervision of professional users in physiotherapy, rehabilitation and adjacent areas.
Never adjust a table top section when the patient is supporting on it with his/her full weight.
The table top sections of some ManuMax couches are supported by gas springs. These ensure
an easy adjustment and stable positioning of the table top sections. However, the gas springs
are not strong enough to adjust a section while supporting the full weight of the patient.
The arm rests will not be completely blocked after releasing the gas spring. The locking is
sufficient for supporting the arms, but is not suitable for exerting much more force on them.
Please, do not sit on them.
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.
Do not use any alcohol-based or aggressive cleaning agents.
If moisture or any material gets into the couch, turn it off, unplug it from the wall socket, and
have it checked by an authorised service technician before using the couch again.
Never use a mix of disinfectants or a mix of disinfectants and soap.
Prevent moisture from accumulating in the hinges of the metal frame. (Prolonged exposure to
moisture in the hinges may cause rust in the worst case scenario).
Regularly (monthly) check the functioning of the head/back section lock.
If the treatment couch is equipped with a motor, disconnect the plug from the wall socket if
the height adjustment is not used for a prolonged period of time.
Have your couch revised annually by authorised Enraf-Nonius staff.
Page 10 of 20 EN109-1570750-40 IFU
In the event the control equipment does not work properly, unplug the power cord from the
wall socket. Check for damage and trapped cables.
Make sure there is no patient on the couch and plug the power cord back into the wall socket.
Carefully check whether the control equipment works properly. If the problem persists,
disconnect the power cord from the wall socket and contact your supplier.
If you notice any mechanical damage to the couch, do not use the couch and contact your
supplier.
An annual inspection by an Enraf-Nonius authorised service technician is required to determine
whether the couch can still be safely used or must be decommissioned.
The ‘Safe Working Load’ of the couch is 250 kg. This means that the total weight on the couch
(patient weight plus any other load such as manipulation by the therapist) must not exceed
250 kg.
Never leave children alone with this device.
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.
In the lowest possible position, pay particular attention to the following situation:
Under the head section, between the head section and the floor.
Make sure you never leave your foot on the all-around control and never get your foot or any
object stuck under the all-around control. Especially when sitting next to the couch this may
constitute an entrapment hazard.
Make sure that no objects can get under the couch or between the moving parts of the couch.
Do not sit on the head section or end of the leg section of the couch.
Page 11 of 20 EN109-1570750-40 IFU
The head section and arm rests are not suitable to sit on, but only to support the head and
arms.
When adjusting table top sections, avoid getting body parts between hinged parts.
Make sure that you and persons near or on the couch keep a sufficient distance from these
hinged parts.
The bottom clearance of the couch is 95 mm. It is therefore possible to place a lifting device or
emitter under the couch with a base that is not higher than 95mm. Make sure not to make
contact with the motor when placing the lift or emitter. Placing objects under the couch with a
height exceeding 95 mm may result in dangerous situations and serious damage.
Try to limit the continuous use of the motors. For every 2 minutes that the couch is operated in
succession, it should not be used for 18 minutes in order to cool down completely. If the
engine is used significantly more than this, it falls outside the normal use of the motor, and the
performance of the motor will decrease.
The treatment surfaces of the couch are not anti-static.
Use a clean couch cover/towel/terry cloth cover/paper cover for each patient. This will
guarantee the hygienic conditions.
Page 12 of 20 EN109-1570750-40 IFU
7 Operation
Digital lock
A digital lock is standard on the couch.
We recommend you always enable this lock when the couch is
unattended.
Enabling it will ensure the couch's motors cannot be operated, and the
couch cannot be used. This will prevent the couch from being adjusted
unintentionally.
Press both buttons ▲ and▼ on the foot end of the couch for 2
seconds to enable or disable the lock. One beep means the couch is
locked. Two beeps means the couch is ready for use.
When trying to operate the couch while the lock is engaged, this will
also be indicated by two beeps.
If the couch is not operated for 30 minutes, it will lock automatically.
The default settings of the digital lock can be changed as follows:
Press and hold both buttons for 30 seconds until you hear 3 beeps. When you hear the beeps, release the
buttons. Now press 1 of the lock buttons several times to select the desired mode. One or more beeps will
sound. The number of beeps represents the selected setting:
Press once (1 beep sounds) = lock enabled time of 30 minutes
Press twice (2 beep sounds) = lock enabled time of 60 minutes
Press three times (3 beep sounds) = lock can only be enabled and disabled manually
Press four times (4 beep sounds) = lock completely disabled
If no button is pressed after this for 15 seconds, the new setting will be stored and the setup mode is exited.
Moving the couch
Press the control lever down with your foot to put the couch on its
wheels.
Never move the couch with a person or a weight on the
couch. Only move the couch on a level surface. The couch is
not suitable for riding over thresholds.
Push the lever back up to put the couch back on its legs before using /
applying a load to the couch.
Height adjustment using the all-around control
The couch can be adjusted up or down by moving the all-around
control by foot. The all-around control is accessible from all four sides
of the couch.
Carefully push the control down to raise the couch. Move the control
up to lower the couch.
Page 13 of 20 EN109-1570750-40 IFU
Height adjustment using other control options
In some cases, the height of the couch can be adjusted using another
control
Foot control: Press one side of the foot pedal. The up side is indicated
by a '+', the down side by a '-' sign.
Table switch: This switch is mounted under 1 of the table top sections.
This switch can be found on both sides of the couch.
Manual control: Optionally, a manual control is available with up and
down push buttons.
Setting the back and seat section
Pull the lever under the back section with one hand and adjust the
section to the desired angle. Release the lever and the section will be
secured in the set angle.
Never adjust a table top section when the patient is
supporting on it with his/her full weight. The table top
sections of some ManuMax couches are supported by
gas springs. These ensure an easy adjustment and stable
positioning of the table top sections. However, the gas
springs are not strong enough to adjust a section while
supporting the full weight of the patient.
Setting the head section
Pull the lever under the head section towards you and adjust the
section to the desired angle.
The head section can also be raised without using the lever. Lowering
the head section always requires the lever to release the gas spring.
If your couch is equipped with adjustable arm rests, there will be a
second lever under the head section.
Setting the arm rests (optional)
Pull the lever under one of the arm rests towards you and move the
arm rests to the desired position. The arm rests are interconnected and
will move together.
The arm rests will not be completely blocked after
releasing the gas spring. The locking is sufficient for
supporting the arms, but is not suitable for exerting
much more force on them. Please, do not sit on them.
Page 14 of 20 EN109-1570750-40 IFU
Treatment couch with electric flexion position and Trendelenburg
Electrically raise flexion: press table switch ▲(1)
Electrically lower flexion: press table switch ▼ (2)
Raise Trendelenburg:
press table switch ▲ (1) , and then use one hand to unlock the leg
section lever (3) and put the leg section in the angled position using
the other hand.
Never adjust a table top section when the patient is
supporting on it with his/her full weight. The table top
sections of some ManuMax couches are supported by
gas springs. These ensure an easy adjustment and stable
positioning of the table top sections. However, the gas
springs are not strong enough to adjust a section while
supporting the full weight of the patient.
Page 15 of 20 EN109-1570750-40 IFU
8 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 the first use and before disinfecting the couch.
Use a damp cloth and mild soap to clean the couch.
Do not use any alcohol-based or aggressive cleaning agents.
Use a damp cloth and clean water to remove any soap residue.
If moisture or any material gets into the couch, turn it off, unplug it from the wall socket, and
have it checked by an authorised service technician before using the couch again.
Disinfection
Before disinfecting the couch, clean it as described above.
Follow the instructions as provided in the instructions for use of the disinfectant.
Never use a mix of disinfectants or a mix of disinfectants and soap.
Preferably apply the product to the imitation leather using a cloth.
Prevent moisture from accumulating in the hinges of the metal frame. (Prolonged exposure to
moisture in the hinges may cause rust in the worst case scenario).
The disinfectants listed on the insert sheet are tested and safe for use on the upholstery of the couch.
For the most recent version of the list, please consult www.enraf-nonius.com/downloads
Comments:
Since we have no influence on the production and raw materials of the disinfectants, it is impossible
for us to generally guarantee that these agents will not damage the upholstery.
Maintenance
Regularly (monthly) check the functioning of the head/back section lock.
If the treatment couch is equipped with a motor, disconnect the plug from the wall socket if
the height adjustment is not used for a prolonged period of time.
Have your couch revised annually by authorised Enraf-Nonius staff.
Page 16 of 20 EN109-1570750-40 IFU
Malfunctions
In the event the control equipment does not work properly, unplug the power cord from the
wall socket. Check for damage and trapped cables.
Make sure there is no patient on the couch and plug the power cord back into the wall socket.
Carefully check whether the control equipment works properly. If the problem persists,
disconnect the power cord from the wall socket and contact your supplier.
If you notice any mechanical damage to the couch, do not use the couch and contact your
supplier.
Expected Service Life
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
ManuMax will remain suitable for its intended use.
End of Service Life
The ManuMax 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.
Page 17 of 20 EN109-1570750-40 IFU
9 Specifications
Electrical Info
Mains voltage 100 - 240 Volt
Frequency 50/60 Hz
Power consumption 250 VA max
Safety and performance standards
Safety class II Type B, according to IEC 60601-1
Moisture resistance IPX1
Safe working load 250 kg
Medical classification Class I in accordance with MDD (93/42/EEC)
Performance
Lifting capacity 250 kg
Height adjustment speed Approx. 2.5 cm/second
Dimensions
Width Depending on the configuration, 67 or 80 cm
Length Depending on the configuration, approximately
205-215 cm
Height Adjustable from approximately 48 to 96 cm
Weight Depending on the configuration, approximately
100 kg
Upholstery
Biocompatible In accordance with 10993-1
Latex-free Yes
Fire retardant DIN EN 1021 (optional Crib. 5 BS available)
Subject to technical modifications
Environmental conditions
Environmental conditions for transport and storage
Environment temperature: –10 to +50° C
Relative humidity: 20 to 90% (non-condensing)
Atmospheric pressure: 700 to 1060 hPa
Environmental conditions for normal use
Environment temperature: +5 to +40° C
Relative humidity: 20 to 90 % (non-condensing)
Atmospheric pressure: 700 to 1060 hPa
Page 18 of 20 EN109-1570750-40 IFU
10 Contact
For assistance and support, please visit our website www.enraf-nonius.com
The most recent version of these Instructions for Use (in electronic or printed form) can be
obtained free of charge via our website www.enraf-nonius.com, by contacting your supplier or by
calling +31 (0)10 2030600. The Instructions for Use will be sent (free of charge) within 7 (seven)
calendar days.
11 Product liability
Many countries have product liability legislation in place. Such legislation implies, inter alia, that after
a period of 10 years after a product has been placed on the market, the manufacturer can no longer
be held responsible for possible shortcomings of the product.
To the maximum extent permitted by the applicable law, in no event shall Enraf-Nonius or its
suppliers or resellers be liable for any indirect, special, incidental or consequential damages arising out
of the use or inability to use the product, including, without limitation, damages for loss of goodwill,
work or productivity, computer malfunctions, and any other form of business damage or loss, even if
advised of the possibility of their occurrence, and regardless of the legal or equitable theory (contract,
tort or otherwise) on which the claim is based. In no event shall the total liability of Enraf-Nonius
under the terms of this Agreement exceed the sum of the amounts paid for this product and the
amounts received by Enraf-Nonius for support of the product in the context of a separate support
agreement (if any), except for death or personal injury caused by Enraf-Nonius's negligence to the
extent that the applicable law prohibits limitation of liability in such cases. Enraf-Nonius cannot be
held liable for any consequences resulting from incorrect information provided by personnel, or errors
in this manual and/or other accompanying documentation (including commercial documentation).
The other party (the user of the product or its representative) shall indemnify Enraf-Nonius against
all claims by third parties of whatever nature and regardless of the relationship with the other party.
Page 19 of 20 EN109-1570750-40 IFU
EN109-1570750-40P0 IFU
Copyright: Enraf-Nonius B.V.
Vareseweg 127 | 3047 AT | Rotterdam | The Netherlands
Tel: +31 (0)10 20 30 600 | info@enraf-nonius.nl
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Enraf-Nonius CD-ROM ManuMax Examination & Multi User manual
- Type
- User manual
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