Akces-Med PARAPION User manual

PARAPION
™
STANDER
USER MANUAL

R
CAUTION! Manufacturer takes responsibility for proper
usage of the device only when the product was purchased
from qualified Akces-Med employee or at specialized
medical store!
CAUTION! AKCES-MED Ltd. reserve the right to introduce
technical and trading changes in the content of the
instruction without warning.
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.
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.
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CONTENT
1. The purpose of user manual.....................................................................................................................5
2. Indications for use .....................................................................................................................................5
3. General characteristics of standing frame..............................................................................................6
4. Size table.................................................................. ...................................................................................8
5. Mounting the standing frame ..................................................................................................................9
6. Rules of adjusting the standing frame to the user...............................................................................10
7. The use of standing frame.......................................................................................................................14
8. Safety rules ...............................................................................................................................................20
9. Maintenance and cleaning ......................................................................................................................21
10. Labelling........................................................................... .......................................................................23

The static verticalizer PARAPION was designed to help in rehabilitation
of people with paresis of lower limbs as well as trunk and to enable
standing in upright position. 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 etc.
Remember to read this user manual carefully. You will find not only useful
information but also guidelines regarding safe and effective use of the product.
If you have any questions or remarks, do not hesitate to contact with us:
Medical consultant: mobile +48 508 382 509
Akces-MED Sp. z o.o.: ph. +48 17 864 04 77
e-mail:
Thank you for purchasing our product.
export@akces-med.com
: www.akces-med.com '+48 17 864 04 70 *e[email protected]
CAUTION! Before using the product, user is obliged to
familiarize himself/herself with user manual. Remember
that complying with guidelines is highly important. It assures
safety and extends durability as well as aesthetics of the
device.
INTRODUCTION

5
THE PURPOSE OF USER MANUAL
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SEINDICATIONS FOR U
The device is recommended for people in the following cases:
nDegeneration conditions.
nBrain and spinal cord disorders with paraplegia, hemiplegia, balance and motor
coordination disorders.
nDemyelinating disease (e.g. multiple sclerosis – SM).
nMeningocele.
nMuscles diseases with weakness and paralysis (dystrophy, myasthenia gravis,
myositis).
nGenetic disorders.
nDegeneration and metabolic disorders.
nAfter head and spinal cord injuries and spine trauma with paralysis and paresis
with paraplegia, especially in quadriplegia condition (as a stage of rehabilitation
process or permanent orthopedic support).
nCerebral palsy – various types and forms.
The present user manual contains basic information which is essential
for proper usage, preparation, maintenance, cleaning and guarantee conditions
PARAPION™ standing frame.
User manual should be kept in easily accessible place. It is designed for
people who look after the disabled, and for both doctors as well as
physiotherapists who operate the device.
Remember that complying with guidelines is highly important. It assures safety
and extends durability as well as aesthetics of the device.
THE PURPOSE OF USER MANUAL
CAUTION! Before using the product, user is obliged to
familiarize himself/herself with user manual.

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1
4
2
5
3
1. Frame with rotating wheels equipped with brakes
2. Hip clamping-ring with belt
3. Chest clamping-ring with belt
4. Knee stabilizer with pelot-pads
5. Table
GENERAL CHARACTERISTICS OF STANDING FRAME
3.1. Standard equipment

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Soft cover for tray
Aid for moving patients
AM_P Tango Wheel 75 mm/100/125
Tray for manual therapy
Tray
Low armpits supports
Independently adjustable knee
support Forearm supports Longer pelvic or chest belt
High armpits supports
PPN_002 PPN_003
PPN_108
PPN_111 PPN_112 PPN_116
PPN_140 PPN_401
PPN_403
PPN_015
PPN_020
PPN_016
3.2. Additional equipment

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Symbol
A [cm] 23 31 38
C [cm] 61-90 80-104 92-122
Pelvic support circumference [cm] 56-76 80-102 95-124
A1 Chest support width [cm] 23 31 38
C1 Chest support height [cm] 73-111 92-126 107-163
Chest support circumference [cm] 56-76 80-102 95-124
G Knee supports width [cm] 12-22 16-24 20-31
HKnee supports height [cm] 18-45 24-49 31-71
Foot length [cm] 20 27 30
Max user weight [kg] 30 55 95
Szerokość [cm] 56 56 67
Długość [cm] 75 87 93
Wysokość [cm] 73 92 107
Waga [kg] 17 21,5 27,5
UWAGA: Tolerancja wymiarów zawartych w tabeli wynosi +/- 1 cm.
A1
A
C
C1
G
H
I
4SIZE TABLE
Measurement Unit Size 1 Size 2 Size 3
Measurement Unit Size 1 Size 2 Size 3
Pelvic support width
Pelvic support height

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MOUNTING THE STANDING FRAME
5
ATTENTION! Assembly of the standing frame should begin by
inserting the pelvic support (hip support) into the guides placed in
the frame (as seen in the figure). Next, we mount the chest
support in a similar way. Afterwards we mount the table and foot
stabilizator (in any order ) as shown in the picture .
Pelvic support
Chest support
Tray
Knee support

Adjusting the device to the patient:
1. Measure the length from the ground to the knee joints. Set the knee
support at this height.
2. Measure the distance between the ground and the trochanter of the
thighbone. At this height set the pelvis(hip)support.
3. Measure the distance between the ground and axillary(armpit). Set
the chest support at this height.
4. We approach the standing frame with the patient in his chair.
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RULES OF ADJUSTING THE STANDING FRAME TO THE USER
6
WARNING! Adjustment of the standing frame to the
patient is done by trained personnel only! All exercises
must be performed only in the company of
appropriately trained personnel.

5. Stabilize feet on the foot stabilizer with the straps.
Straps in the knee stabilizer and knee
supports should be unfastened. Place
the feet in the foot stabilizer, retracting
the foot (pushing it back) to the metal
clamp/support and fastening the
straps.
In the case of occurrence of abduction-adduction in the forefoot of the
patient , the feet in the foot stabilizer
should be set at an appropriate angle.
6. Stabilize the knees in previously set
knee supports by additionally
fastening the stabilization straps.
7. Open the hip and chest supports.
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8. We position the patient in standing frame.
9. Fasten the hip and chest
supports , additionally securing
with belts.
Chest support fastening elvic support fastening P
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10. Check if the patient is standing straight, and if the projections of
shoulders, hips and knees coincide in a straight line. If not than we
should adjust the hip, knees and chest support, so that the patient
stands straight. This is very important as it prevents the formation of
contractures in the ankle joints, knees and hips.
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9
9.1. Preparation of the patient
Before using the product, it is essential to make sure that:
· patient's outfit is light and comfortable sporty clothes are advisable;
· shoes should be comfortable and, moreover, they should stabilize
ankle;
· due to hygienic reason and to avoid abrasion it is advisable for the
patient to always wear clothes when using the device, skin must not
be naked especially in places of regular contact with upholstery;
· drains, bags, catheters etc. if applied, have to be secured to function
properly and not to disturb during using the product;
· if it is necessary for a patient to wear orthopedic supply (collar, corset,
orthesis, shoes) if it is recommended by doctor.
7
CAUTION! PARAMOBIL™ has to be used with compliance to
guidelines included in this user manual. Remember to use the
product only with someone who is trained and
knowledgeable. Do not forget to prepare both product as well
as patient before using PARAMOBIL™!
THE USE OF STANDING FRAME
CAUTION! Outfit should protect patient's skin from direct
contact with upholstery as well as other parts of equipment.
CAUTION! Only doctor can make a decision concerning
using any kind of orthopedic supply!

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7.2.
Before use it is necessary to:
· Unfold the device;
· Place the device on a flat surface allowing for easy access to the standing
frame at a safe distance from sources of ignition and high temperature
· Make sure that all parts are serviceable, correctly mounted and stable;
· Check the condition of castors and brakes;
· Block brakes;
· Adjust the device to patient's measurements;
· Place patient in the device;
· Fasten all elements which stabilize patient;
· Mount additional equipment.
Equipment works correctly only when the device is adjusted according
to patient's height as well as weight. Remember to take all these
measurements into account while purchasing the product. Correct
adjustment is the most important due to the fact that only then the
product is safe. It is forbidden to force child to keep specific position
because he/she will feel uncomfortable and it may lead to wrong
posture.
How to use standing frame
CAUTION! First adjustment of standing frame can be
performed only by someone who is traned. Further
adjustment is performed by patient's relatives who had
proper training concerning the usage as well as adjustment
of this device. Remember that correct adjustment is essential
due to the fact that the product is safe and, moreover, the
rehabilitation process is proceeding correctly.
CAUTION! Remember to makes sure that all belts and
locking and correctly adjusted and fastened. Check also if
fastenings from adjustable elements are firmly tightened.

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9.3. Upright position
CAUTION!
The length of time for upright position process is different for each
patient. It is recommended to extend this time during the initial period
(adaption period for the change of position). Either doctor or
physiotherapist can make decision concerning the length of upright
position process. Upright position process has to be always performed
under the supervision of trained person!
It is recommended to divert patient's attention during upright position
process by:
- manipulation games
- educational games
CAUTION! It is highly important to adjust the device to the
patient before using it!
CAUTION! Make sure that all belts as well as fastenings
from adjustable elements are correctly adjusted and
fastened.
CAUTION! It is forbidden to leave the patient unattended!
CAUTION! Only trained staff can adjust standing frame to
the patient!

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CAUTION! As far as first upright standing is concerned, it
takes place in rehabilitation, neurosurgery or orthopedics
wards. Moreover, it has to be performed together with doctor
and physiotherapist due to the fact that medical problems
may appear during first treatments such as fainting, drop in
blood pressure, dizziness etc. Upright standing is continued
in home together with trained staff (rehabilitation technician,
district nurse, trained family members).
CAUTION! Incorrect adjustment of the device can lead to
side effects such as: fainting, body deformities, overloading
joints. It is highly advisable to adjust the device before every
use of a standing frame. This adjustment has to be done only
by a trained person or therapist. If any of these side effects
appear, it is highly important to stop the upright position
process, take out the patient from the device and lie him/her
down. If these undesirable side-effects still occur it is
necessary to contact doctor. If these side effects
disappeared, remember to inform doctor so as to make
decision concerning further upright position process.

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8 SAFETY RULES
1.
It is highly important to consult either doctor or physiotherapist in order
to make right decision concerning the choice of PARAPION™ and its size. It is
also essential to familiarize with the guidelines described in user manual before
using the device.
Before use it is necessary to:
· make sure that there are no damages or different faults which could
endanger patient's life; check if all parts are working and are correctly
mounted and, moreover, check if they are not broken;
· check if all screws, knobs and all glued, sewed or tapped parts are tightened;
· check if brakes are operating correctly;
· check if buckles are operating correctly;
· always use safety belts, Velcro tapes should overlap min. 8cm;
· adjust the device according to patient's measurements and needs;
· make sure that all movable parts and knobs for adjustments are stable and
locked;
· secure patient with the aid of elements such as pelvic harness. It is highly
important to secure patient because it safeguards him/her from falling
out.
CAUTION! Dynamic standing frame PARAPION™ has to
be used in compliance with guidelines in this user manual.

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2. It is forbidden to use the device for different purposes that it is intended to.
3. It is forbidden to use the device when it is damaged or any part is missing.
4. It is forbidden to leave the patient unattended.
5. The device should be used only when there is someone who is trained and
knowledgeable.
6.It is forbidden to leave the device and the patient on unstable ground
unattended, even if the brake is engaged.
7. It is forbidden to either go up or down the stairs; it doesn't matter if the patient
is placed in the device or not.
8.It is important to engage brake during getting into and getting out the device.
9.Make sure that all limbs are not close to spokes or other adjustable elements.
10.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 using the device. Moreover, device shouldn't be
stored in rooms with high humidity.
11. Secure the device during transportation in order to avoid any possible
damages. Manufacturer doesn't take responsibility for damages which
appeared due to improper preparation of the device during transportation.

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1) AKCES-MED Sp. z. o. o sells products free from manufacturing defects or
faults.
2) Manufacturer gives the purchaser 24-month guarantee from the date of
purchase. All defects revealed during warranty period will be repaired free of
charge.
3) All defects which appear after warranty period can be repaired only when the
user will pay for it. This rule doesn't apply to refunded products - user can ask
National Health Refund for refund.
4) Manufacturer claims that the product can be used for 48 months. User can
use this product after this period only when he/she will send the device to
manufacturer so as to service it. Next, manufacturer determines again how
long the product can be used and, moreover, the date of the next service will
be determined.
5) If product is damaged, please contact our dealer or AKCES-MED customer
service (ph. 17/864 04 70)
CAUTION! This device can be only used inside the buildings.
CAUTION! The device contains small parts which children may
swallow.
CAUTION! It is forbidden to make any changes concerning
device's structure due to the fact that it is dangerous and it
results in loosing warranty.
CAUTION! The weight of user should not be bigger than
maximal weight described on page 10 where you will find
information regarding this issue.
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2
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