Enraf-Nonius aXionXelect Zimmer User manual

Enraf-Nonius
Brand
Enraf-Nonius
Model
aXionXelect Zimmer
Type
User manual
Instructions for Use
aXionXelect
EN
Contents
1
Introduction
2
Symbols
3
Package contents
4
Installation
5
Intended use and intended user
6
Precautionary instructions
7
Operation
8
Safety instructions
9
Cleaning, maintenance and troubleshooting
10
Specifications
11
Contact
12
Product liability
Introduction
1
EN109-1550752-40
Page 1
We are pleased that you have purchased an aXionXelect 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 aXionXelect a great deal of care
was put into the reliability, safety, ease of use and durability.
Symbols
2
EN109-1550752-40
Page 2
Follow the instructions in the Instructions for Use.
It is important that you read, understand and observe the precautionary and
operating instructions
Warning or Caution:
Indicates a hazardous situation which, if not avoided, could result in:
a. Death or serious injury to the patient (or)
b. Minor to moderate injury to the patient (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.
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.
Model Number
Reference Number or Part Number
Serial Number
Indicates the serial number so that a specific medical device can be
identified.
Indicates that the item is a medical device.
Indicates a carrier that contains Unique Device Identifier information.
CC
Configuration code
IP
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
Symbols
2
EN109-1550752-40
Page 3
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.
Alternating current
Product is in conformity with the European Union Medical Device Regulation
(EU) 2017/745
Risk of crushing hands
Package contents
3
EN109-1550752-40
Page 4
aXionXelect
Instructions for Use
Information sheet first use
Cable Clip
Information sheet disinfection of upholstery
Ordering data
For the ordering data of the aXionXelect standard accessories and optional
accessories we refer to www.zimmer.de
Installation
4
EN109-1550752-40
Page 5
Unpacking the
device
The device is heavy, it must be unpacked by at least 2 persons.
Do not lift the couch by the table top parts or the all-around control.
Inspection
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!
Installation
Read this Instructions for Use carefully before using the equipment.
Avoid exposure to direct sunlight, UV radiation, rain, excessive dust, moisture,
mechanical vibrations, and shocks.
The aXionXelect couches are not intended for use in so-called “wet rooms”
(hydrotherapy rooms).
The device may not be used in close proximity (i.e. less than 2 metres) to
shortwave or device.
The aXionXelect should be placed on a flat surface.
Turn the adjustable foot until it touches the ground and the couch is standing
stable.
For correct assembly and safe use of possible optional accessories one must
consult the separately provided documents included with the optional
accessories.
Follow the instructions for connection of controls and connection to mains
supply on the information sheet First Use supplied with the treatment couch.
Connection to mains
supply
Mains supply connections must comply with the national requirements
regarding medical rooms.
Prior to connection of this device to the mains supply, check that the voltage
and frequency stated on the type plate correspond with the available mains
supply.
Intended use and intended user
5
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Page 6
Intended use
The aXionXelect 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 axionXelect 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.
Precautionary instructions
6
EN109-1550752-40
Page 7
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!
Read this Instructions for Use carefully before using the equipment.
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!
Avoid exposure to direct sunlight, UV radiation, rain, excessive dust,
moisture, mechanical vibrations, and shocks.
The aXionXelect couches are not intended for use in so-called “wet rooms”
(hydrotherapy rooms).
The device may not be used in close proximity (i.e. less than 2 metres) to
shortwave or device.
The aXionXelect should be placed on a flat surface.
Turn the adjustable foot until it touches the ground and the couch is standing
stable.
For correct assembly and safe use of possible optional accessories one must
consult the separately provided documents included with the optional
accessories.
Mains supply connections must comply with the national requirements
regarding medical rooms.
Prior to connection of this device to the mains supply, check that the voltage
and frequency stated on the type plate correspond with the available mains
supply.
The aXionXelect is only meant to be used by competent personnel in
physiotherapy, rehabilitation or adjacent areas. Avoid any use of the
equipment by unauthorized personnel.
When used by children, supervision by a knowledgeable (para)medic is
obligatory. At all times keep children away from the equipment when no
supervision is at hand or use a safety switch.
Use both hands to change the couch settings: one hand for unlocking and
the other to adjust the section.
Precautionary instructions
6
EN109-1550752-40
Page 8
Never adjust a section when it supports the full weight of the patient!
Each section of this aXionXelect 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 150 kg is allowed with the 6000N motor
SL56 (standard motor) when the height of the couch is being adjusted.
A maximum patient’s weight of 250 kg is allowed with the 8000N motor
SL80 (optional motor) when the height of the couch is being adjusted.
Be aware of the duty cycle of the motor. The motor is not designed for
continuous operation. For every 25 seconds the motor is running, it needs
400 seconds to cool down. If you do use the motor considerably longer
without allowing it to cool down sufficiently, a thermal cut shuts off the power
and protects the motor against overheating. In that case, let the motor cool
down until it functions again.
The couch is not anti-static.
For safety reasons, the wheels of the unit should be retracted before the
beginning of a treatment.
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.
When adjusting this couch, keep hands and feet away from the couch for at
least 20 cm, especially on places that has been marked by these stickers.
When adjusting the sections, squeezing-danger can arise at contact points of
the section. Keep enough distance between you or your clients and these
points.
Head section: is not suited to sit upon and must be used to support the head
only.
Always use the original accessories that are meant for this product.
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.
Precautionary instructions
6
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Page 9
The aXionXelect should be checked once a year by authorized personnel of
Zimmer MedizinSysteme or by its authorized distributor.
The manufacturer will not be held responsible for the results of maintenance
or repairs by unauthorized persons!
Operation
7
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Page 10
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 aXionXelect 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 150 kg is allowed with the 6000N motor SL56
(standard motor) when the height of the couch is being adjusted.
A maximum patient’s weight of 250 kg is allowed with the 8000N motor SL80
(optional motor) when the height of the couch is being adjusted.
Be aware of the duty cycle of the motor. The motor is not designed for
continuous operation. For every 25 seconds the motor is running, it needs 400
seconds to cool down. If you do use the motor considerably longer without
allowing it to cool down sufficiently, a thermal cut shuts off the power and
protects the motor against overheating. In that case, let the motor cool down
until it functions again.
The couch is not anti-static.
The operation of your aXionXelect 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 (optional).
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.
For safety reasons, the wheels of the unit should be retracted before the
beginning of a treatment.
Activation with
autolock box
(optional)
Couches equipped with an autolock box located at the bottom frame, must first
be activated by pressing the button on the autolock box. The green light
indicates that the couch is active. After 30 minutes the couch is automatically
locked again.
Operation
7
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Page 11
Electric height
adjustment
By pressing the foot switch continuously,
the required height can be reached.
Height adjustment
with the all-around
operation (optional)
By pressing or pulling the all-around
operation - which is located underneath
the framework - with your foot, the
required height of the couch can be set. At
the head section of the couch, the height
can be adjusted by turning the handle to
the left or to the right.
Never let your full weight rest on the switch bar!
Adjusting the back
section
Use one hand to pull the handle
underneath the back section, while
adjusting the section in the desired
position. Release the handle and the
section will be fixed.
Adjusting the head
section
Use one hand to pull the handle
underneath the head section while
adjusting the section in the desired
position. Release the handle and the
section will be fixed.
Releasing the rolling
section (traction)
Release the rolling section by pulling out
the stop pin. Turn the pin slightly if you
want to prevent it from clicking back into
the locking mechanism.
Locking the rolling
section (traction)
To lock the rolling section again, turn the
pin such that it can click back into the
starting position.
Safety instructions
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Page 12
Danger of squeezing
the extremities
On this couch warning stickers are placed.
When adjusting this couch, keep hands
away from the couch for at least 20 cm,
especially on places that has been marked
by these stickers.
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 beside (the couch is set in flexion
position combined with the lowest possible
position):
Underneath the head section, between the
head section and floor.
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.
Danger of tilting
Do not sit on the head and leg section of
the couch.
Safety instructions
8
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Page 13
Adjustment of the
sections
When adjusting the sections, squeezing-
danger can arise at contact points of the
section. Keep enough distance between
you or your clients and these points.
Load
Head section: is not suited to sit upon and
must be used to support the head only.
Cleaning, maintenance and
troubleshooting
9
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Page 14
Cleaning
Use a clean couch cover / towel / terry cloth / paper cover for every individual.
This is required to guarantee a hygienic use.
Do not use agents that contain alcohol or other aggressive cleaners.
• 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.
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 www.zimmer.de
Remark:
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.
Maintenance
If you encounter any problem with the aXionXelect, stop using the couch and
contact your supplier.
• 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.
The aXionXelect should be checked once a year by authorized personnel of
Zimmer MedizinSysteme or by its authorized distributor.
The manufacturer will not be held responsible for the results of maintenance or
repairs by unauthorized persons!
Cleaning, maintenance and
troubleshooting
9
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Page 15
Troubleshooting
Disconnect the mains cable from the electricity supply if the all-around-operation
is not working appropriately.
Then check whether the three operation elements of the all-around-operation
are in a neutral position: the bar on the left and on the right plus the handle.
At the short-sided edge of the couch, where you
can find the small operation handle, there is a cord
that runs to the underside of the couch. Try to
follow this cord with your hand as far as possible,
till you can pull it loose carefully from the small pin.
– see the small illustration alongside, illustration is
a bottom view –.
Uncouple the cord for a moment and put it back
again. Afterwards you can connect the mains
cable with the electricity supply and bring the all-
around-operation back into use.
Expected service life
This device will remain suitable for its intended use as long as it is subjected to
yearly maintenance by a qualified service engineer as described in the service
manual and the service engineer deems the device fit for use according to
specifications.
End of life
Your aXionXelect contains materials which can be recycled and/or are noxious
for the environment.
Please ensure that you are well informed of the local rules and regulations
regarding the removal of equipment and accessories.
Specifications
10
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Page 16
Technical data
Height adjustment
ca. 48 – 105 cm
Length
ca. 207 cm (ca. 240 cm incl. traction frame)
Width
ca. 67 cm
Lifting capacity
150 kg with the standard motor SL56 of 6000N
250 kg with the optional motor SL80 of 8000N
Motor speed
6 mm/sec for both types
Mains voltage
230V~ 50/60 Hz or 115V~ 50/60 Hz
Current consumption
1.5A for the 6000N motor, 230V~ 50/60 Hz
2.0A for the 8000N motor, 230V~ 50/60 Hz
2.4A for the 6000N motor, 115V~ 50/60Hz
4.1A for the 8000N motor, 115V~ 50/60Hz
Applied part
Type B: tabletop
IP classification
IPX0 (treatment couch)
Upholstery
Type AKV Peri
Fire safety
DIN EN 1021 part 1/2
Free of phthalates
yes
Biological
DIN EN ISO 10993-5
DIN EN ISO 10993-10
Technical modifications reserved!
Specifications
10
EN109-1550752-40
Page 17
Safety and
performance
standards
Medical device
classification
Class I
This equipment complies with all requirements of the Medical Device
Regulation (EU) 2017/745.
Safety class
according to IEC
60601-1
II, double insulated
Type B Applied part
Environmental
conditions
Environmental
conditions for
transport and storage
Environmental temperature
-20° to +60° C
Relative humidity
30 to 70% (non-condensing)
Atmospheric pressure
700 to 1060 hPa
Environmental
conditions normal
use
Environmental temperature
-10° to 40° C
Relative humidity
30 to 70 % (non-condensing)
Atmospheric pressure
700 to 1060 hPa
Contact
11
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Page 18
The aXionXelect is especially made for:
Zimmer MedizinSysteme GmbH
Junkersstr. 9
89231 Neu-Ulm
Germany
Tel: +49 (0)731 97610
www.zimmer.de
Manufacturer
Enraf-Nonius B.V.
Member of Zimmer Group
Vareseweg 127
3047 AT Rotterdam
The Netherlands
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Enraf-Nonius aXionXelect Zimmer User manual

Enraf-Nonius
Brand
Enraf-Nonius
Model
aXionXelect Zimmer
Type
User manual
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