Akces-Med PARAPION Manuale utente

P A R A P I O N ™
STANDING FRAME
USER MANUAL

5°C
70%
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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!
AKCES-MED. Ltd. reserve the right to introduce technical and trading
changes in the content of the instruction without warning.
Product marked with the CE sign is Class I medical device, of
rule 1, consistent with the requirements of Regulation (EU)
2017/745 of the European Parliament and of the Council of 5
April 2017 on medical devices.
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.
35°C

CONTENT
1. The purpose of user manual.....................................................................................................................5
2. Indications and contrindications for use ................................................................................................5
3. General characteristics of standing frame..............................................................................................7
4. Size table.................................................................. ...................................................................................9
5. Mounting the standing frame ................................................................................................................10
6. Rules of adjusting the standing frame to the user...............................................................................11
7. The use of standing frame.......................................................................................................................15
8. Safety rules ...............................................................................................................................................19
10. Maintenance and cleaning ...................................................................................................................22
11. Labelling..................................................................................................................................................25
9. Terms of warranty.................................................................................................................................... 21

e-mail: export@akces-med.com
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.
Medical consultant: mobile +48 508 382 509
Akces-MED Sp. z o.o.: ph. +48 17 864 04 77
Stable construction, ergonomic knee supports, wide pelvic and chest belts are
the basic elements ensuring safety and comfort during the therapy. The user,
who is placed in this device, is able to perform rehabilitation treatment as well as
simple domestic or professional activities. The standing frame is equipped with
four noiseless castors which enable easy relocation of the user.
If you have any questions or remarks, do not hesitate to contact with us:
We know very well how important it is for the user to adopt the standing position,
that is why we have created a product called PARAPION™ which is ideally suited
for this purpose. PARAPION™ allows you for full and safe upright standing.
Thank you for purchasing our product.
: 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
5
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The standing frames are intended for people with orthopedic, neurological and
cardiological diseases and for people after surgery who are unable to adopt and maintain
a standing position on their own as a result of prolonged immobilization. The device is an
irreplaceable aid in the rehabilitation process, both in terms of movement and social
integration. It is great help in everyday activities such as rehabilitation but also during
playing or studying. The selection of the appropriate size of the device depends on
medical indications and anatomical parameters, regardless of the age of the user.
The device is recommended for people in the following cases:
§ demyelinating disease (e.g. multiple sclerosis – SM),
§ meningocele,
§ brain and spinal cord injuries with lower limbs paralysis and weakness,
§cerebral palsy – various types and forms,
§ balance and motor coordination disorders with different etiology,
§ muscles diseases with weakness and paralysis (dystrophy, myasthenia
§ gravis, myositis),
§ genetic disorders,
§ egeneration and neurological diseases,
§ paresis.
§ other condition connected with muscles weakness, paralysis and
§ after head and spinal cord injuries and spine trauma with paralysis and
§ musculoskeletal disorders,
The present user manual contains basic information which is essential for :
§preparation before use,
§proper usage,
§maintenance, cleaning and guarantee conditions.
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. Before using the PARAPION™ standing frame, user is obliged to familiarize
himself/herself with user manual.
1 THE PURPOSE OF USER MANUAL
2 INDICATIONS AND CONTRINDICATIONS FOR USE

Contraindications:
While standing upright, the user who is in a standing position should be closely
monitored. The therapy should be discontinued in case of such side effects as: turning pale,
sweating or fainting, joint strain and the resulting deformities of the body. Further
proceeding should be consulted with the medical specialist or a physiotherapist who
prescribed the treatment. The critical condition of the user is an absolute contraindication
to standing upright.
• Any condition, such as a healing fracture or severe osteoporosis, that makes it impossible
to bear the user's own bodyweight.
• Postoperative restrictions on joint loading.
• Pain while standing in the standing frame (caused by subluxation or dislocation of the hip
joint, overstretching of soft tissues or excessive pressure). Subluxation or dislocation of
the hip joint in the absence of pain is not a contraindication.
In case of people with impaired cardiovascular system (arterial hypertension at rest above
200/110 mmHg, pulmonary hypertension, cardiac arrythmias, moderate heart valve
disease); respiratory system (unstable asthma) and unstable metabolic disorders, it is
necessary to monitor the user while standing in order to prevent serious complications.
People with significant flexion in the hip or knee joints, as well as with contractures in the
ankle joint, may not be able to use the standing frame. Make sure that the position of the
user in the standing frame does not cause excessive pressure or stretching of affected
areas of the body. In such cases, standing upright may be contraindicated until a greater
range of motion is achieved in the contracted joints.
•Relative contraindications for upright standing are: arterial hypertension at rest above
200/110 mmHg, pulmonary hypertension, cardiac arrythmias, unstable asthma, unstable
metabolic disorders, moderate heart valve disease.
• Bone fracture with incomplete union, unless approved by a doctor.
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2. Foot plate with foot stabilization,
1. Frame with castors and brakes,
4. Chest brace with chest belt (adjustable),
7. Tray with plate (size 1)
3. Adjustable knee support,
5. Pelvic brace with pelvic belt (adjustable),
6. Low armpit supports,
GENERAL CHARACTERISTICS OF STANDING FRAME
3.1. Standard equipment
1
7
3
5
4
2
7
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3.2. Additional equipment
Podpórki pod pachy wysokie
PPN_002 PPN_003 PPN_015
PPN_016
PPN_020
PPN_111 PPN_112 PPN_116
PPN_140
Chest support
PPN_157
Pelvic support
PPN_158
Longer chest belt
PPN_159 PPN_401
Independently adjustable knee
supports Forearm supports Longer pelvic belt
Tray
High armpit supports
Tango Wheel 75 /100/125 mm
Soft cover for tray
Belt for moving patients
AM-P
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4SIZE TABLE
Symbol Measurement Unit Size 1 Size 2 Size 3
W Indicative user height* [cm] 90 – 140 110 – 170 140 – 200
A/A Pelvic/chest support width
1[cm] 23 31 38
C Pelvic support height [cm] 61 – 90 80 – 104 92 – 122
C Chest support height
1[cm] 73 – 111 92 – 126 107 – 163
Pelvic/chest support circumference [cm] 56 – 76 80 – 102 95 – 124
G Knee supports width [cm] 12 – 22 16 – 24 20 – 31
H Knee supports height [cm] 18 – 45 24 – 49 31 – 71
I Footer length [cm] 23 27 30,5
Max. user weight [kg] 30 55 95
Note: Measurement tolerance range is +/- 1 cm / ½ in.
*This measurement cannot be the main parameter while choosing the product size.
Weight and dimensions Unit Size 1 Size 2 Size 3
Width [cm] 56 56 67
Lenght [cm] 75 87 93
Height [cm] 73 92 107
Weight [kg] 17 21,5 27,5
Note: Measurement tolerance range is +/- 1 cm / ½ in.
Note: Approximate values, depending on the product configuration.
9
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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
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