Akces-Med PARAPION User manual

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

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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.
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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: [e-mail]
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 [phone]
Akces-MED Sp. z o.o.: ph. [phone]
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.
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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
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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
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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.
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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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4. We approach the standing frame with the patient in his chair.
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.
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.
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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.
6. Stabilize the knees in previously set
knee supports by additionally
fastening the stabilization 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.
7. Open the hip and chest supports.
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Chest support fastening Pelvic support fastening
8. We position the patient in standing frame.
9. Fasten the hip and chest
supports , additionally securing
with belts.
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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
· if it is necessary for a patient to wear orthopedic supply (collar, corset,
orthesis, shoes) if it is recommended by doctor.
· 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;
Before using the product, it is essential to make sure that:
9.1. Preparation of the patient
7
CAUTION! PARAPION™ 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 PARAPION™!
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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§ Block brakes;
§ Undo vest, trunk belts etc so as to place easily the patient is the device;
8.2. How to use PARAPION
§ Place patient in the device;
§ Fasten all elements which stabilize patient e.g. vest, trunk belts, feet
stabilizing belts etc.;
§ Mount additional equipment e.g. tray.
§ Place the device on even ground;
1. Before use it is necessary to:
§ Make sure that all parts a re serviceable, correctly mounted and stable;
§ Adjust the device to patient's measurements;
§ Unfold the device;
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.
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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CAUTION!
It is recommended to divert patient's attention during upright position
process by:
- manipulation games
- educational games
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!
- touch stimulation and others
Only trained staff can adjust standing frame to the patient!
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).
It is highly important to adjust the device to the patient before using it!
Make sure that all belts as well as fastenings from adjustable elements
are correctly adjusted and fastened.
It is forbidden to leave the patient unattended!
8.3. Upright position
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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
· always use safety belts, Velcro tapes should overlap min. 8cm;
· 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;
1. Before use it is necessary to:
· check if buckles are operating correctly;
· 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.
· make sure that all movable parts and knobs for adjustments are stable and
locked;
· adjust the device according to patient's measurements and needs;
· check if all screws, knobs and all glued, sewed or tapped parts are tightened;
· check if brakes are operating correctly;
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.
CAUTION! 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.
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.
3. It is forbidden to use the device when it is damaged or any part is missing.
5. The device should be used only when there is someone who is trained and
knowledgeable.
9.Make sure that all limbs are not close to spokes or other adjustable elements.
10.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.
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.
4. It is forbidden to leave the patient unattended.
12. Before using the stander, remove all paper and plastic packaging. The
packaging is not a toy! Keep away from children and animals
This device can be only used inside the buildings.
The device contains small parts which children may swallow.
Do not use a product that has any signs of damage, tearing or wear.
Only anundamaged product and proper use guarantee its right and
safe working. If the product is damaged, discontinue use and contact
the manufacturer.
Incorrect product adjustment can lead to such side effects as fainting,
body deformities, joint overload, etc. If the abovementioned symptoms
occur, stop using the product immediately, take the user out of the
product and lay them down. If the undesirable symptoms persist,
contact a physician immediately. If the symptoms have disappeared,
inform the attending physician about this fact in order to make a
decision about the further rehabilitation process.
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