Akces-Med smart User manual

SMART™
USER MANUAL
STANDING FRAME

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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.
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.
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CONTENTS
1. The purpose of instruction manual...................................................................................5
2. Indications for use..............................................................................................................5
3. General characteristics of Smart static standing frame.............................................6
3.1. Standard equipment..................................................................................................6
3.2. Additional equipment................................................................................................6
4. Size table... ...........................................................................................................................7
5. Desription how to assembly standing frame.................................................................8
5.1. Assembly of standing frame size 1 and 2.............................................................8
5.2. Assembly of standing frame size 3 and 4............................................................10
6. Desription how to use standing frame..........................................................................13
6.1. Pelvic and chest brace.............................................................................................13
6.2. Knee support............................................................................................................15
6.3. Foot support.............................................................................................................16
7. Additional equipment.........................................................................................................17
7.1 SM_023 Soft cover for tray...................................................................................17
8. The use of standing frame..............................................................................................18
8.1 The preparation of patient...................................................................................18
8.2 How to use Smart................................................................................................19
8.3 Upright position.....................................................................................................20
9. Safety rules..........................................................................................................................22
10. Maintenance and cleaning...............................................................................................25

INTRODUCTION
passive upright position. The product is easy in use thanks to which family as
well as hospital staff find it easy to look after patient. Furthermore, smart is
equipped with the system of precautions. It is highly beneficial due to the fact
that patient feels safe and comfortable regarding his upper limbs. Both chest
and pelvic brace perfectly adjust to patient's body which has an influence on his
upright position. The product is equipped with castors which make it easy for
patient to relocate. What is more, its construction is well planned because of
which it eliminates barriers which patient may come across. Additionally, it
exerts a positive influence on patient's mood and motivates him to overcome
any difficulties with regard to injury or diseases.
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 [phone]
Akces-MED Sp. z o.o.: ph. [phone]
e-mail:
Thank you for purchasing our product.
SMART™ is a solid device which makes it possible for patient to adopt
[e-mail]
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.
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The present user manual contains basic information which is essential
for proper usage, preparation, maintenance, cleaning and guarantee conditions
SMART™ static 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.
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THE PURPOSE OF USER MANUAL
SEINDICATIONS FOR U
CAUTION! Before using the product, user is obliged to
familiarize himself/herself with user manual.
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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.

1. Frame with castors and brakes
2. Pelvic pelotte with pelvic belt
3. Chest pelotte with chest belt
4. Knee support with pelottes
5. Foot support with pelottes
6. Tray
3.2. Additional equipment
3.1. Standard equipment
GENERAL CHARACTERISTICS OF STANDING FRAME
SMD_003 Soft cover for tray
SMD_002 Aid for moving
patients AM_P
SMD_428 Tray with edge
SMD_427 Tango Wheel
Safety Comfort
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4
6
3
2

Symbol Measurement Unit Size
0a 1 1a 2 2a 3 3a 4
APelvic support width [cm] 22 22 28 28 37 37 44 44
CPelvic support length [cm] 18-44 18-65 24-68 28-86 28-92 30-107 30-110 33-129
A1 Chest support width [cm] 20 20 26 26 35 35 42 42
C1 Chest support length [cm] 41-56 58-76 55-80 70-96 72-107 86-121 86-126 106-145
Chest support circuit [cm] 50-64 50-64 64-76 64-76 80-105 80-105 95-125 95-125
GKnee supports spacing [cm] 8-10,5 8-10,5 11-14 11-14 14-20 14-20 16,5-25 16,5-25
HKnee supports length*[cm] 11-35 11-55 12-57 13-72 14-78 14-88 14-96 14-98
KFootplate length [cm] 17 17 20 20 24 24 30 30
Maximum user weight [kg] 35 35 55 55 75 75 95 95
Weight and dimensions of the device 0a 1 1a 2 2a 3 3a 4
width [cm] 50 50 60 60 70 70 78 78
length [cm] 63 63 70 70 87 87 91 91
height [cm] 55 70 70 75 75 92 92 110
weight [kg] 10 10 12 13 19,8 20 24,4 26
Note: Dimensional tolerance in the table is: +1/-1 cm.
*Knee supports height depends on the height of the tray.
A
A
A
A
1
1
C
C1
G
H
K
SIZE TABLE
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5.1 Follow these rules so as to assembly SMART™ standing frame in size 1 and 2:
STEP 1. Insert posts into holes in the frame so as that mesure is placed towards
the outside of the device (pic. 1, 2)
STEP 2. Fasten posts to the frame with the aid of eight screws (pic 3).
STEP 3. Tighten all screws by means of Allen wrench (pic 4).
DESRIPTION HOW TO ASSEMBLY STANDING FRAME
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STEP 4. Place upper part of standing frame with belts, tray and knee support on
frame with posts (pic 5).
STEP 5. Adjust the height at your discretion and tighten screws at posts with the
aid of Allen wrench (pic 6).
pic 1 pic 2
pic 3 pic 4
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STEP 6. Standing frame is equipped with
tray. In order to unfold tray it is necessary
to:
źloosen four fastenings from tray which
are placed on both sides with the aid of
Allen wrench;
źNext, unfold tray's top (fig.1) and block
it by pressing top (fig.2) and tightening
tray's fastenings (fig.3, fig.4).
On the platform and tray, you can find yellow
stickers showing the front side of the standing
frame. In order to assemble the product properly,
the arrows on the stickers should be pointing the
same direction. After successful assembly of the
standing frame, the stickers can be removed.
pic 5 pic 6
fig. 1
fig. 2
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5.2.
STEP 1. Insert transverse frame into profiles for frame (pic 7, 8).
Follow these rules so as to assembly SMART™ standing frame in size 3 and 4:
STEP 2. Put footplate on frame's posts with castors (pic 9).
STEP 3. Look at footplate, insert six screws with pads- four screws in the corners
of base, two under footers (pic 10).
fig. 3 fig. 4
pic 7 pic 8
pic 9
pic 10
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STEP 4. Tighten all screws with the aid of
Allen wrench (pic 11).
STEP 5. Put upper part of Smart on frame
(pic 12).
STEP 7. Standing frame is equipped with
tray. In order to unfold tray it is necessary
to:
źloosen fastening from tray with the
aid of Allen wrench,
źNext, unfold tray's top (fig.5) and
block it by pressing top (fig.6) and
tightening tray's fastenings (fig.7,
fig.8).
STEP 6. Tighten screws at frame's profile
with the aid of Allen wrench (pic 13).
pic 11
pic 12
pic 13
fig. 5
On the platform and tray, you can find yellow
stickers showing the front side of the standing
frame. In order to assemble the product properly,
the arrows on the stickers should be pointing the
same direction. After successful assembly of the
standing frame, the stickers can be removed.
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fig. 6
fig. 7 fig. 8
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6.1. Pelvic and chest brace
6.1.1 Chest belt is fastened with the aid of
Velcro tapes (fig.9).
Chest belt is equipped with stabilizing belts
which are fastened by means of Velcro
tapes. It is possible to choose either longer
(fig.10) or shorter (fig.11) belts depending
on patient's measurements.
6.1.2.Pelvic belt is fastened with the aid of Velcro tapes (fig.12) Patient should be
placed in pelvic belt as it is presented on photo (fig.13). Pelvic belt can be
mounted on frame at any height. Belt stabilizes buttocks and makes it possible
to adapt correct position in standing frame.
DESRIPTION HOW TO USE STANDING FRAME
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fig. 9
fig. 10 fig. 11
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6.1.3.Pelvic belt is equipped with stabilizing
belts which are fastened with the aid of
Velcro tapes. It is possible to choose either
longer (fig.14) or shorter (fig.15) belts
depending on patient's measurements.
Pelvic belt should be adjusted in a way that
patient adopts upright position.
6.1.4. So as to adjust the suitable height of
torso braces it is necessary to loosen
screws which are situated at the frame (fig.
16). Activity should be repeated for the
second frame.
fig. 12
fig. 13
fig. 15
fig. 14
fig. 16
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6.2. Knee support
6.2.1. Loosen fastening situated on frame in order to change the height of knee
support . Next, adjust the height of standing frame at your discretion and tighten
firmly fastening (fig.17). Activity should be repeated for the second frame. Knee
support can be adjusted either forwards or backwards. It is necessary to loosen
four fastenings situated on the sides of standing frame (fig.18). Next, adjust
standing frame at your discretion and fasten fastenings.
6.2.2. It is possible to adjust each pelotte
from knee support individually. Loosen
fastening situated at the front of knee
support, adjust knee pelottes at your
discretion and fasten fastening (fig.19).
Regarding pelottes, they can be adjusted at
any angle.
6.2.3. Concerning size 1 and 2, knee pelottes
are equipped with belts which are fastened
by means of Velcro tapes (fig.20).
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fig. 17 fig. 18
fig. 19
fig. 20
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6.3.2.The adjustment of foot support can be
easily changed. Loosen footer's fastening,
adjust the position at your discretion and
fasten fastening. It is possible to adjust at
sides, forwards or backwards. Moreover,
support can be adjusted at any angle
(fig.22).
6.3. Foot support
6.3.1. Foot support is equipped with criss-
crossed belts and heel counters (fig.21).
fig. 21
fig. 22
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CAUTION! SMART™ standing frame should be used in
compliance with guidelines in this user manual. Before using
the product, it is highly important to prepare both patient and
device.
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7.1
So as to put soft cover for tray it is necessary to put it on tray and then fasten
cover under top with the aid of Velcro tapes (fig.23, 24, 25).
Soft cover for tray
ADDITIONAL EQUIPMENT
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fig. 23 fig. 24
fig. 25
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SMD_003

THE USE OF STANDING FRAME
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8.1. 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.
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CAUTION! SMART™ 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 SMART™!
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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8.2. How to use SMART
1. Before use it is necessary to:
· Unfold the device;
· Place the device on even ground;
· Make sure that all parts are serviceable, correctly mounted and stable;
· Block brakes;
· Adjust the device to patient's measurements;
· Undo vest, trunk belts etc so as to place easily the patient is the device;
· 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.
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.
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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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8.3. 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
- touch stimulation and others
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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