Akces-Med PARAMOBIL User guide

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STANDING FRAME
PARAMOBIL
™
Use and Maintenance Instruction

TABLE OF CONTENTS:
1. Purpose of the instruction s. 2
2. Recommendation of the usage the verticalizer PARAMOBIL s. 2
3. General characteristics of verticalizer PARAMOBIL s. 3
4. Technical specification of verticalizer PARAMOBIL s. 3
5. Standard accessories of each verticalizer PARAMOBIL s. 5
6. Assembly of verticalizer PARAMOBIL s. 6
7. Preparation to use – safety measures s. 8
8. Patient's preparation s. 10
9. Basic rules of adjustment verticalizer by a user s. 10
10. Maintenance and cleaning of verticalizer PARAMOBIL s. 15
Medical product first class according to the Regulation 93/42/EWG
of European Parliament and Council regarding medical products.
For this product the producer issued relevant declaration of conformity.
Producer's identification number in the Registration Department of Healing Products,
Medical Products and Biocide Products:
PL/CA01 04088/W
Akces-Med Sp. z o.o. Company introduced quality management system
ISO 13485 regarding production, sales and service.
The system is certified by Det Norske Veritas..
13485
QUALITY
MANAGEMENT
SYSTEM

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The static-dynamic rehabilitation verticalizer was designed to
help in rehabilitation of people with paresis of lower limbs as well as trunk
and to enable standing in upright position, walking and active
rehabilitation. We did our best to give you the product which is functional,
ergonomic and safe. The advantages of our verticalizer are: light and
stable base, easy regulation of hip clamping-ring and chest clamping-
ring, solid closings etc.
Please read this instruction manual carefully. You will find
information about our product and will learn how to use it safely and
efficiently.
If you have any questions or comments, please contact our Medical
Adviser at (tel. [phone]) or directly AKCES - MED Ltd. at (tel.
[phone]).
We thank you for purchasing our product.
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1. Purpose of the instruction
This instruction contains all basic information needed to use verticalizer
PARAMOBIL properly, preparation before using the device, rules of
patient's preparation, ways of maintenance and cleaning and the
conditions of guarantee. It should be kept in a readily available place.
The instruction is dedicated to disabled persons who use static-dynamic
rehabilitation verticalizer PARAMOBIL as well as persons who directly
take care of the disabled, doctors, physiotherapists, etc.
Before taking any action with the device you must read the content of this
instruction and make sure that all the information, recommendations and
warnings contained in it are fully comprehensible.
2. Recommendation of the usage the verticalizer PARAMOBIL
Clinical trials confirmed the recommendations of use of devices in
treatment and preventive treatment of many various illnesses, particularly
in:
- improvement of action of cardiovascular system,
- preventive treatment and treatment of venous stagnations,
- improvement of lungs ventilation and preventive treatment of
pneumonia,
- preventive treatment of pulmonary artery embolias,
- preventive treatment and treatment of osteoporosis,
- preventive treatment and treatment of urinary system stagnations,
- improvement of peristalsis of intestines,
- help in re-education of neurogenic vesicle,
- improvement of psychic condition,
- preventive treatment of amyotrophy,
- preventive treatment and treatment of contractures, improvement
of joints movability.
The decision to define the form of rehabilitation, including use of
verticalizer must always be made by a leading doctor.

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3. General characteristics of verticalizer PARAMOBIL
The static-dynamic verticalizer PARAMOBIL is intend for active
rehabilitation of disabled people with paresis of bottom limbs and trunk.
The device permits disabled person to stand with other people's help or
independently and safely (although under supervision) – static function. It
also permits to walk forward and backward – dynamic function, as well as
do simple activities of everyday life in straight erect position.
Using of mechanical-electrical rotor and chair with regulation of height
makes possible to rehabilitate patient's lower limbs in up-right position
–rehabilitation function.
Thanks to its simplicity verticalizer PARAMOBIL is unusually valuable
device during rehabilitation of the disabled at home, in hospital or
rehabilitation centers' conditions. The proper use of it may contribute to a
considerable improvement of the quality of disabled persons' life.
4. Technical specification of verticalizer PARAMOBIL
Verticalizer PARAMOBIL is available in 3 sizes:
PARAMOBIL
1 2 3
width of base/length of base (cm)
distance between base and armpit clamping-ring (cm)
66/90
108-138
79-113
32
32
24-33
66/90 72/90
118-153 122-157
83-123 93-128
37 44
37 44
25-36 28-38
A/B
C
D
E
F
85 110 125
G
distance between base and hip clamping-ring (cm)
internal width of armpit clamping-ring (cm)
internal depth of armpit clamping-ring (cm)
circumference of chest and hips (cm)
internal width of hip clamping-ring (cm)
internal depth of hip clamping-ring (cm)
maximum weight (kg)
WHEELS IN PARAMOBIL (STANDARD OPTION):
TORSION WHEELS WITH BRAKE
WHEELS AS ADDITIONAL OPTION:
- RUBBING BRAKE (MAKING DIFFICULT PATIENT'S MOVE)
- POSSIBILITY OF BLOCKING STRAIGHT RIDE
- BLOCKING OF WHEELS' REGRESSING RIDE WITH POSSIBILITY OF UNBLOCKING
THIS FUNCTION
60 90 120
15-30-36 20-31 23-35
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H
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4
D
B
G
GH
C
E
E
F
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5. Standard accessories of each verticalizer PARAMOBIL
- Frame with rotating wheels equipped with brakes (1)
- Chest clamping-ring with pelot-pads (2)
- Hip clamping-ring with pelot-pads (3)
- Upper limbs stabilizers (bolsters and grips) (4)
- Feet stabilizer (5)
- Knee stabilizer with pelot-pads (6)
- Table (7)
- Seat (8)
- Mechanical-electric rotor (9)
- Lower limbs separator with upholstery (10)
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3
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6
58
9
10
7
1
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6. Assembly of verticalizer PARAMOBIL
A. Static version
Picture 1
Picture 2
Picture 3
Picture 4
Picture 5
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B. Dynamic version
Chest and hip clamping-rings and upper limbs stabilizers should be
installed like in static version (pictures 1 and 3)
Chest and hip clamping-rings and upper limbs stabilizers should be
installed like in static version (pictures 1 and 3)
Picture 6
C. Rehabilitation version
Picture 8
Picture 9
switch
knob of adjustment
the engine resistance
Plug of
power supply
Picture 10
Picture 7
7
Install the separator according to the picture 6
Install seat according to picture 8
Tighten the rotor according
to picture 7
complete the rotor
according to pictures 9
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7. Preparation to use – safety measures
Verticalizer PARAMOBIL will correctly fulfill its function if it is adjusted to
growth and weight of patient's body. Therefore during the purchase you should
pay attention to the parameters (size 1, 2, 3) given on page 3. Regulation and
adjustment should be always carried out by authorized service agent - therapist.
The main principle of adjustment the device to the patient is maximum feeling of
safety.
Safety measures
1. Verticalizer PARAMOBIL should be used according to the
recommendations placed in this instruction.
2. Before use:
- make sure that all units are in working order and correctly installed and the
device does not show any signs of cracks or deformations,
- check that the screws, nuts or other screwed connections are not slacken,
- check the functioning of clamping-rings' locks,
- check the brakes and wheels functioning,
- make sure that the movable units are stable and blocked.
3. The device should not be pulled on, jerked or turned over especially if the
patient stands in it.
4. The verticalizer PARAMOBIL should not be used unless a trained member
of a family or someone entitled to take care of the disabled is around.
5. It should never be used on unstable ground, stairs or steep slopes and also
should not be left on sloping surfaces.
6. The device cannot be used if is damaged or any of its part is missing.
7. Although the device and the upholstery are made of fire-resistant materials,
please pay your attention when approaching to sources of fire or sources of
high temperature during exercises.
8. It is absolutely forbidden to use the device by a patient who is influenced by
alcohol, intoxicants, drugs and other substances which can have a negative
influence on patient's sense of balance or consciousness.
9. Verticalizer should be used in clean, dry and well ventilated room in the
o
temperature of 15-35 C and relative humidity not exceeding 80%.
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AKCES-MED Ltd. sell the device technically efficient, free of constructional,
assembly or material defects etc.
Verticalizer PARAMOBIL is covered by 24 months guarantee as of the day of
purchasing the product by a patient.
Manufacturer is not responsible for damage in the following cases:
- result of servicing the verticalizer by unskilled staff
- using verticalizer during absence of qualified staff
- incorrect installing the units and accessories
- modifying the units independently
- using not original units and accessories
- natural abrasion and wearing away of units (upholstery, wheels etc.)
- damage as a result of incorrect use (concerning unsuitable load and size
selection of verticalizer to the given patient)
- not complying with the principles contained in this instruction.
The conditions of guarantee are given in details on guarantee card which is
attached to verticalizer.
WARNINGS:
- special caution should be kept during unpacking the device (cutting of
package) in order not to damage the upholstery
- assembly of verticalizer should always be made by an entitled person
(salesman, dealer) or medical staff accordingly trained
- verticalizer PARAMOBIL is the equipment for individual use
- verticalizer PARAMOBIL should be operated by persons who have read and
learnt the instruction manual precisely
- verticalizer PARAMOBIL should be operated by entitled persons such as: the
rehabilitants, doctors of rehabilitation and qualified staff after a previous
training
- verticalizer PARAMOBIL may be used both on rehabilitation squads and in
patient's house in the presence of suitably trained persons only.
Additional information:
- cleaning of the verticalizer should be performed in accordance with the
instruction "Maintenance and cleaning” section (page 15)
- in case of any incident or damage please contact the dealer who sold the
product
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8. Patient's preparation
Before any action with the verticalizer every patient is obliged to comply with
the following recommendations:
1. Footwear should be deep, highly-laced and should stabilize ankle. It is
recommended to use orthopeadic footwear.
2. Clothes should be casual and convenient, airy, not limiting movements; sport
wear (for physical exercises) is the best one.
3. Any drains, bags, catheters etc., if they are applied, have to be well protected
in order not to fall out, move of shift and not to disturb while standing in
straight position.
4. In case of using corset, girdle, collar, orthopeadic footwear or orthosis you
should put them before exercises in the verticalizer.
The decision to define form of rehabilitation and use particular orthopeadic
article must be always made by a doctor.
5. To keep hygiene and to avoid body's attritions you should not practice in the
device without clothes fully covering that parts of your body which touch the
upholstery.
9. Basic rules of adjustment verticalizer by a user
The adjustment of verticalizer to the patient should be always made by
suitably trained staff.
Suitably trained persons have to assist patient while doing exercises.
Verticalizer PARAMOBIL has a module construction equipped with three
functions: static, dynamic and rehabilitating. Selection of particular units of the
verticalizer and their proper adjustment depends on chosen functions. (The unit's
assembly in particular function is given on page 6 and 7).
A. STATIC FUNCTION
- patient's passive verticalization, keeping optimal and stable posture of user,
who is supported in every neuralgic area (feet, knees, hips, chest and back)
Verticalizer should be placed back down in front of patient then you should block
the wheels' brakes and unlock the fasteners of hip and chest clamping-ring.
Not blocking the wheels of verticalizer can cause its shifting while uprising,
which results in patient's fall, breakage or body's injury.
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VELCRO stickers in the feet stabilizer and on knee pelot-pads
should be unfastened. Place feet into feet stabilizer, shift them
backward maximally to the metal clamping-ring and then
fasten VELCRO stickers (picture 1).
Verticalize patient, fasten both fasteners of hip and chest
clamping-ring (double protective system – upper and lower
blockades). Then adjust the knee pelot-pads to
user's knees (vertical and horizontal regulation)
by unfastening the snap fasteners, shifting pelot-
pads and fastening the snap fasteners. Finally
button up VELCRO stickers (picture 2 and 3).
Please pay attention during clamp fastening.
Characteristic sound “click” should be heard.
It inform you that the clamp was fasten
correctly.
During coming into verticalizer or getting out of it you mustn't rest on rear
clamping-rings' locks while they are being opened.
The attempts of overloading the opened
locks of clamping-ring can cause a fall
of device or deformation, which results
in incorrect functioning of fastener lock.
After blocking of feet and knees adjust
the location of hip and chest clamping-
ring.
Chest clamping-ring – perpendicular
regulating
Chest clamping-ring should be installed
in such position, which enables patient
to rest safely on pelot-pads. To regulate
height of chest clamping-ring use knobs
(A) (pic. 3)
picture 1
foto 2
picture 3
A
A
B
B
C
D
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Hip clamping-ring – perpendicular and horizontal regulating
Hip clamping-ring should be fixed at the level of trochanter of lower limbs (to
regulate perpendicularly use knobs B). After fixing height you must regulate
position of hip clamping-ring to the hips using knobs C (regulation forward and
backward) and then the knobs D (hips regulation –picture 3)
The proper position of trunk and pelvis depends on precise adjusting.
The ideal position is one line of arms, trunk and hips.
CAUTION! While regulating the height of the hip clamping-ring and chest
clamping-ring you cannot exceed the double lines on cantilever.
Patient's forearm should be placed on
supporters (their height can be regulated),
hands should be placed on handles (their
location can be regulated) by inserting a
hand between Velcro sticker and handle
(picture 4). Applying of handles
facilitates control over verticalizer and
improves safety.
Straight position is safe and comfortable. While standing in this position patient
is being adapted to the vertical position as well as sense of equilibrium, internal
organs, circulation system are being adopted to the new conditions and to bigger
load.
Patient can stand in straight position quite long time; can simultaneously do
exercises or simple everyday-life activities etc. To facilitate simple everyday-
life activities we recommend installation of a table. ). It possesses the regulation
of height and surely it will be useful to put a book, a cup or laptop on it (picture 4)
During exercises and walking the table must be disassembled!
B. DYNAMIC FUNCTION
- Enables people with paresis of lower limbs moving
Like in static function, before any action with the verticalizer block the wheels'
brakes, open locks of hip and chest clamping-rings and verticalize the patient.
Hands and forearms should be placed on supports and adjusted similarly as in
static function.
picture 4
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If all elements are adjusted and patient feels well, you can unblock the wheels'
brakes and start exercises.
When the patent tends to cross lower limbs
please use a separator (picture 5), which
should be installed according to picture on
page 7.
Feet separator has been covered with soft
upholstery, which eliminates attritions or
injuries of lower limbs.
First steps should be made forward then
backward and finally to different directions.
While walking, at the beginning you should
make normal steps then fester and flower
steps.
We recommend using special paths in order
to help in order to help in orientation both
courageous and not courageous patients.
C. REHABILITATION FUNCTION
-Enables active rehabilitation of patient's
flower limbs in vertical position.
Specific construction of verticalizer
PA R A MO B I L e n a b le s t o u s e t h e
rehabilitation function separately or by
reassembly of accessories of dynamic and
static functions (without necessity of leaving
the verticalizer).
First of all rise the hip clamping-ring
maximally up (but the location of chest
clamping-ring should not be changed).
Then install a seat (description on page 7).
In case of using feet separator (dynamic
version) please disassemble it and in that
place install the seat.
Height of seat should be adjusted to the
patient.
picture 5
picture 6
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In static version, at the beginning, disassemble connector of pipes from the pelot-
pads (picture 11) and assemble seat. Next, when patient safely seats, screw off
the feet stabilizer and knee stabilizer.
Saddle should be screw tight with verticalizer's frame using the 4 screws wich
are added as standard equipment. If you don't screw it tight enough or if you
don't use all 4 srews the binding plate can deflect. In such cases the
complaints will not be taken into consideration.
The next step is installation of mechanical-electric
rotor - (description on page 7) and connection of
protective transformer.
Patients' feet should be placed on rotor's feet
holders and Velcro stickers should be fastened.
Shin also should be supported by Velcro fasteners.
After accomplishing the above-mentioned actions
you can start exercises:
- Mechanical version – patient uses strength of his
muscles.
Rotor's resistance regulates with a knob (Picture 9 on page 7)
- Electric version – work of electric engine is used. In order to this, please
connect protective transformer (Picture 9 on page 7).
CAUTION!
Before switching on the transformer to plug-in socket, please switch off the
knob that regulates the resistance of engine.
Not applying to the above-mentioned recommendation can result in
burning of electric engine!
Do not leave the rotor on if patient doesn't use it. The electric engine can be
blocked and can burn or can be mechanically damaged. In such cases the
complaints will not be taken into consideration. Repair cost will be cover by
user.
During using of electric rotor patient should seat on saddle comfortable.
Unacceptable is to stand by patient onto rotor's pedal.
After exercising with verticalizer PARAMOBIL patient must return safely on
wheelchair, chair, armchair, bed etc.
Patient cannot leave verticalizer independently.
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To leave verticalizer the following should be done
(hints for doctors of rehabilitation):
1. Block the wheels of verticalizer using brakes.
2. At the back of verticalizer put the wheelchair, chair, armchair etc.
3. Unfasten Velcro stickers in feet stabilizer and knee pelot-pads (static
version)
4. Unblock the protection of opening of both pelot-pads
5. Seat patient on wheelchair, chair, armchair etc gently.
Therapist is obliged to patient's insurance at side or at the back.
CAUTION:
You should pay your special attention to block the wheels of wheelchair and
protect the chair or armchair before patient is going to seat on it.
Backing off of the seat can cause patient's fall or injuries.
10. Maintenance and cleaning of verticalizer PARAMOBIL
Verticalizer - as an individual orthopedic supply and a medical device, should be
kept clean and used in compliance with the manufacturer's recommendations.
The device should be kept in clean, dry and ventilated room in the temperature of
15-35°C and relative humidity not exceeding 80 %.
Preservation and cleaning of the device have to be performed at least once a
month.
Regular cleaning and preservation of verticalizer PARAMOBIL are
indispensable to maintain its correct functionality and safety.
Maintenance of wheels
It is recommended to clean the wheels and remove hair, dust, ash etc. at least
once a month. You should also the wheels with special spray.
Manufacturer recommends using WD-40 (a free of charge sample has been
attached to the article).
Maintenance of construction and upholstered units
Whole construction and upholstery of PARAMOBIL should be cleaned with soft
cloth moistened in diluted alcohol, after cleaning should be dried gently.
In case of using verticalizer by many patients (in the hospitals, rehabilitation
centres or other places), and the rules of the abovementioned institutions are not
different, both hand handles should be disinfected before transferring the device
to next person (the best way is to wipe with alcohol). Absolutely impermissible is
direct contact the upholstery with uncovered patient's body.
grease
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Only in case of exact compliance with all above recommendations, the
responsibility for correct work of the verticalizer PARAMOBIL is on
Manufacturer.
It is not allowed to clean, change units, parts and conserve the verticalizer while
it is being used by the patient.
The responsibility for any other activities with PARAMOBIL is on user.
Manufacturer is responsible only for original and hidden defects or technical
damages occurred during the correct exploitation of the article.
In case a particular unit needs to be changed or serviced or the device needs to be
exchanged please contact the dealer who sold the product.
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Authorised Dealer
ORTHOPAEDIC DEVICES MANUFACTURER
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AKCES-MED Ltd. reserve the right to introduce technical and trading changes
in the content of the instruction without warning.
Akces-MED. Sp. z o.o.
ul. Leszka Czarnego 3
35-615 Rzeszów
tel. [phone]
www.akces-med.com
e-mail: [e-mail]
..
Date of issue: 15.09.2006 : 30.03.2015 The last update