Enraf-Nonius Tree P User manual

Type
User manual
EN-Tree P
EN109-1400755-47 IFU
June 11, 2020
Instructions for use
Page 2 of 16 EN109-1400755-47 IFU
Table of contents
1 Introduction ...................................................................................................................................................... 3
2 Symbols .............................................................................................................................................................. 3
3 Package contents ............................................................................................................................................ 4
4 Installation ......................................................................................................................................................... 5
5 Intended use and intended user ............................................................................................................... 6
6 Contra-indications .......................................................................................................................................... 7
7 Precautionary instructions ........................................................................................................................... 7
8 Operation ........................................................................................................................................................... 9
9 Maintenance .................................................................................................................................................. 13
10 Specifications ................................................................................................................................................. 14
11 Contact ............................................................................................................................................................. 15
12 Product liability ............................................................................................................................................. 15
Page 3 of 16 EN109-1400755-47 IFU
1 Introduction
We are pleased that you have purchased the EN-Tree P pulley. The EN-Tree P offers the possibility to
practice in a very flexible way medical training therapy.
When developing and producing the EN-Tree P, much consideration was given to reliability, safety,
user comfort and durability.
2 Symbols
Symbol
Description
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
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.
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.
Keep the device dry
Manufacturer name, address and date of manufacture.
Reference Number or Part Number
Page 4 of 16 EN109-1400755-47 IFU
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
Product is in conformity with European Council of Medical Device Directive
(93/42/EEC)
Alternating current
3 Package contents
1455.974 EN-Tree P
Standard accessories
1400.755 Instructions for use
Optional accessories
3443.305 Set of 2 handgrips
3443.306 Set accessories for EN-Tree Pulley (consists of 3443.307, 3443.308, 3443.309, 3443.310)
3443.307 Pull Down accessory
3443.308 Lat pulley handgrip
3443.309 Triceps handgrip
3443.310 Ankle strap, 37 cm
3443.313 Leather strap, 73 cm
3447.695 Foot sling
3443.380 Endo-/exo-rotator
3443.381 Bent triceps bar
3443.383 Wrist trainer
3496.253 Row handle
Ordering information
For the ordering data of the EN-Tree P, standard accessories and additional accessories we refer to the
website www.enraf-nonius.com.
Page 5 of 16 EN109-1400755-47 IFU
4 Installation
Inspection
Installation
The EN-Tree P must be installed in such a way that its use is not limited by other objects. Keep at least
2.50 m free around the unit.
The EN-Tree P must be attached to the wall with suitable fittings. The EN-Tree P must only be
mounted on a brick or concrete wall. Position the plugs firmly in the centre of a brick in case of a brick
wall. The fixation must be able to resist a horizontal pulling force of 950 N.
In case of installation of 2 EN-Tree P pulley, we advise you to place the centre of the EN-Tree P at
2.5 m from both sides of the corner (figure 1).
Figure 1
Connection of an adapter other than the prescribed charger can adversely affect the safety of the user
and the functioning of the unit, and is therefore not permitted.
The device is not intended for use in so-called "wet rooms" (hydrotherapy rooms).
Page 6 of 16 EN109-1400755-47 IFU
Mounting of the Pull Down accessory
Please refer to figure 2 for the mounting of the Pull Down accessory.
Figure 2
Figure 3
5 Intended use and intended user
The EN-Tree P is a pneumatic pulley for medical training purposes.
As thus the EN-Tree P can be used for:
Prevention: regular use should prevent cardio-respiratory and locomotor impairments
Rehabilitation: musclar dysbalances can be adjusted / equalized by means of regular us
The EN-Tree Pulley is designed to be used and shall ONLY be used by or under the supervision of
professional users in the field of physical medicine and rehabilitation.
Page 7 of 16 EN109-1400755-47 IFU
6 Contra-indications
Absolute contra-indications
Myocardial dysfunction in an instable phase
HNP in the (sub) acute phase (with irradiation and neurological signs)
Severe osteoporosis
Acute fractures
Severe mechanical instability
Early post-surgical joint modification
Relative contra-indications
Myocardial dysfunction in a stable phase
HNP in the sub-acute phase (without irradiation and neurological signs)
Mild osteoporosis
Late post-surgical joint modification
Tumours
Inflammations in the involved area
Non desired articular load in the involved area (e.g. with M. Osgood-Schlatter, bursites, etc.)
Non desired ligamentous load in the involved area (e.g. sprain with hydrops)
Non desired soft tissue load in the involved area (e.g. with severe atrophy)
Cardiovascular restrictions
Pulmonary restrictions
Psychological restriction
Pain of such cause that movement would not relief
7 Precautionary instructions
Safe execution of the procedures in this manual requires technical experience and general knowledge
of safety precautions as well as general knowledge of the human movement and physiological system.
Warnings, cautions and notes have been used throughout the manual to bring special matters to the
immediate attention of the reader.
The sequence of steps in a procedure is important for the safe handling of the equipment and
prevention of damage. Therefore never change the sequence of a procedure.
Legal aspects
This manual and the information herein are the property of Enraf-Nonius B.V. (Rotterdam, The
Netherlands).
Enraf-Nonius B.V. disclaims any responsibility for personal injury and/or damage to equipment caused
by:
Negligence or disregard of a Warning or a Caution
Deviation of any of the described procedures
Execution of activities that are not described in this manual
Ignorance of the general safety precautions for handling tools and the use of electricity and
pneumatics
Usage of the device in another manner as specified in this manual.
Page 8 of 16 EN109-1400755-47 IFU
Warnings
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!
Always use the original Enraf-Nonius accessories that are meant for this product.
The EN-Tree P should be operated or used by one person at once.
Limbs must be kept clear from moving parts.
Clean the cuffs after usage.
During exercising hands must be kept clear from the guiding bars of the weights.
Never re-set weights during exercising.
Do not change the load settings during exercising or training: load changes are only allowed in
the starting position
Avoid the cord grating along sharp paths.
Keep spectators away from the pulley when it is in use (at least 1 meter).
For safety reasons keep sufficient distance from a unit used for training; one should not be
within 1 meter distance from the outer borders of a unit while it’s used for training
When using the latissimus grip, first the load must be selected, before the grip is mounted. If
you change the weight in the meantime you have to hold the upperweight to prevent the grip
from falling down.
The 45 degrees Pull Down accessory is only intended for support during exercising. Never apply
the full body weight to the Pull Down accessory. The maximum admissible weight for the 45
degrees Pull Down accessory is 50 kilograms.
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!
A correct bio mechanical positioning of the body is necessary.
When the EN-Tree Pulley is not used in the correct way, injury may occur. Supervision by a
knowledgeable paramedic is therefore obligatory.
If pain is experienced during use: stop the training immediately and consult professional
medical help
In case of damage from transport is noticed, contact your local distributor.
DO NOT USE the device!
Caution
Note
In case of any malfunction of your EN-Tree P contact your Enraf-Nonius supplier or Enraf-Nonius
B.V. (Rotterdam, The Netherlands). Have repairs, maintenance and installations carried out by an
authorized Enraf-Nonius service technician
Repairs or maintenance performed by a non Enraf-Nonius authorized service technician and/or
the use of (spare) parts that are not originally Enraf-Nnius made, results in a direct loss of any
guarantee
The maximum resistance setting for the training equipment will be dependent on the pressure of
the compressor
Page 9 of 16 EN109-1400755-47 IFU
8 Operation
Switch on
After switching on the device, a welcome screen will be displayed while the device performs a self-test.
At the end of the self-test the device enters the “stand-by screen” and is ready for use.
Training screen
This screen will show the amount of resistance
in kilograms (kg).
Default value is 5 kg.
The arch above the value indicates that it can
be adjusted by using the rotary knob.
When adjusting the resistance, the device will
tell you to wait until the right amount of force
is set.
The bottom half of the screen will show the
amount of repetitions or the time. Default
setting is zero (-) repetitions.
When the training is started, the device will
count the repetitions made.
Touch the field where the number of
repetitions is displayed to set a number
of repetitions.
Now the device will count down when
making repetitions.
Page 10 of 16 EN109-1400755-47 IFU
Press the clock button if you want to exercise
for a certain amount of time. Use the rotary
knob to set. Time will count down after the
first repetition. (Time will keep counting down,
regardless of the number of repetitions
made.)
When time is up or repetitions counted down
to zero, a beep will sound to indicate work out
is finished.
Series
Press the right tab if you want to
program a training with multiple series.
This can be either series of repetitions or
series of a certain duration.
Simply touch the parameters to adjust
them (the arch will appear to indicate
they can be adjusted with the rotary
knob).
Rest time will automatically start
counting down when a series is
completed. When the rest is over,
training will start when you start moving
again.
If you don`t want to complete a series or
pause, you can use the NEXT button to go to
the next phase.
Use reset to skip the entire training. The
device will return to default settings.
Programmed values will be lost.
Page 11 of 16 EN109-1400755-47 IFU
Record
A bar at the bottom of the screen will
display the range of motion (ROM).
Touch this area to set markers for the
right ROM, start and finish for the
movements.
A screen will open to record two
correctly executed repetitions.
On the bottom of the screen select if you want
to record both ROM and speed or just ROM.
Perform two repetitions. Limits for ROM (and
speed) will be recorded to be used as an
example for the next training session.
Few seconds after the recording is finished,
the EN-Dynamic will return to the training
screen.
Limits for ROM are now shown on the ROM-
bar. Moving outside this ROM will be shown
in red to indicate the movement is not
executed like recorded.
If speed is recorded as well, the speed
bar will show a “ghost” to indicate the
required speed.
If you want to change the ROM or
speed, just press the area with the bars
to start a new recording.
Reset will delete all set parameters for
your training including ROM and speed.
Page 12 of 16 EN109-1400755-47 IFU
Chip card
To execute a training programmed on an EN-
Train or Track chipcard, simply put the card
into the opening at the top of the console
(chip facing down and towards you).
The device will show a welcome screen.
Press OK to start the training.
If the training is completed, a beep will sound
and the device will tell you where to go next
(next device or PC).
Remove chipcard.
Page 13 of 16 EN109-1400755-47 IFU
9 Maintenance
Cleaning
The steel undercarriage can be cleaned with a damp cloth and a (nonabrasive) liquid household
cleaner
Maintenance
To keep the leather parts flexible, you can use leather fat.
After some time, the sliding and turning parts could run less smoothly, because of pollution and
dehydration. You can re-grease the Pulley with ball bearings grease (which you can obtain at a
bicycle shop). If required, the guiding bars of the weights can be greased with a little oil.
Check the cord and the cord fixations regularly for signs of wear. In case of excessive wear and
tear, the cord must be replaced and use of the EN-Tree Pulley is not recommended until the cord
has been replaced.
In order to obtain spare parts, please contact your supplier.
We recommend to have the EN-Tree P checked yearly by authorized personnel of Enraf-Nonius or
by its authorized distributor. The manufacturer will not be held responsible for the results of
maintenance or repairs by unauthorized persons!
Expected service lifetime
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.
The service engineer will decide whether the device is suitable for use according to the specifications.
End of life
Your EN-Tree P contains materials which can be recycled and/or are noxious for the environment.
At the end of the duration of life, specialized concerns can take apart the EN-Tree P and sort out the
noxious materials and materials for recycling. By doing so you contribute to a better environment.
Please ensure that you are well informed of the local rules and regulations regarding
the removal of equipment and accessories.
Page 14 of 16 EN109-1400755-47 IFU
10 Specifications
Technical data
Dimensions
218 x 39 x 35 cm (HxWxD)
Weight
60 kg
Height adjustment for rope
0 200 cm
Load increments
40 to 720 N, in steps of 10 N
Effective weight/load with one cord end
Display value divided in 6
Effective weight/load with two cord
ends combined
Display value divided in 3
For a proper operation of the repetition counter, the movement of 1 cord should be minimum 20
cm or 10 cm with 2 cords.
Technical modifications reserved
Safety and performance standards
Medical device classification
Class I (93/42/EEC)
This equipment complies with all requirements of the
Medical Device Directive (93/42/EEC).
Safety class according to IEC 60601-1
Class II B
Applied parts
Type B Applied part
Environmental conditions
Environmental conditions for transport and storage
Environmental temperature:
10° till +50° C
Relative humidity:
10 to 95% (non-condensing)
Atmospheric pressure:
500 till 1060 hPa
Environmental conditions normal use
Environmental temperature:
10° till 40° C
Relative humidity:
10 to 90 % (non-condensing)
Atmospheric pressure:
800 till 1060 hPa
Page 15 of 16 EN109-1400755-47 IFU
11 Contact
For assistance, please visit our website http://www.enraf-nonius.com
The latest version (in electronic or printed format) of this Instructions for Use can be obtained free of
charge from our website www.enraf-nonius.com or by contacting distributor or by calling the
telephone number: +31-(0)10-2030600. The Instructions for Use will be sent (free of charge) to you
within 7 (seven) calendar days.
12 Product liability
A law on Product Liability has become effective in many countries. This Product Liability law implies,
amongst other things, that once a period of 10 years has elapsed after a product has been brought
into circulation, the manufacturer can no longer be held responsible for possible shortcomings of the
product.
To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or
resellers be liable for any indirect, special, incidental or consequential damages arising from the use of
or inability to use the product, including, without limitation, damages for loss of goodwill, work and
productivity, computer failure or malfunction, or any and all other commercial damages or losses,
even if advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort
or otherwise) upon which the claim is based. In any case, Enraf-Nonius entire liability under any
provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this
product and fees for support of the product received by Enraf-Nonius under a separate support
agreement (if any), with the exception of death or personal injury caused by the negligence of Enraf-
Nonius to the extent applicable law prohibits the limitation of damages in such cases.
The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all claims
arising from third parties, whatever nature or whatever relationship to the opposing party.
EN109-1400755-47
Copyright:
Enraf-Nonius B.V.
Vareseweg 127 | 3047 AT | Rotterdam | The Netherlands
Tel: +31 (0)10-20 30 600 | [email protected]
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Enraf-Nonius Tree P User manual

Type
User manual

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