http://en.akces-med.com/products/dynamic-standing-frames/activall/

USER MANUAL

ACTIVALL Dynamic Standing Frame

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.

INTRODUCTION

As far as this standing frame is concerned, it is highly beneficial to the process of daily rehabilitation which takes place not only in hospitals and rehabilitation wards but also in patient’s house. This device enables the patient to stand and walk.
Moreover, children are able to take first steps and adults can either keep or regain fitness. Both light and stable frame is helpful in independent relocation in this device with slight involvement of the patient. The correct adjustment of braces makes the patient feel secure as well as comfortable during performing activities. Furthermore, this product may be used by patients in different age groups due to a vast array of sizes. This device plays a significant role because of the fact that patient has the possibility of gaining new experience and, more to the point, being independent as far as possible.
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 our medical consultant (ph. 508 382 509) or directly AKCES-MED Sp. Z o.o. (ph. 17 864 04 70).
Thank you for purchasing our product.
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.

THE PURPOSE OF USER MANUAL

The present user manual contains basic information which is essential for proper usage, preparation, maintenance, cleaning and guarantee conditions
ACTIVALL™ dynamic 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.
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.

INDICATIONS FOR USE

The device is recommended for people in the following cases:

• Degenerative arthritis
• Brain and spinal cord damages with lower limb paresis, sever balance and movement disorder, quadriplegia.
• Advanced demyelinating diseases (multiple sclerosis, amyotrophic lateral sclerosis)
• Myelomeningocele.
• Muscle diseases, dystrophy, myasthenia gravis, polymyositis
• Genetic syndromes connected with limb paresis.
• Degenerative and metabolic diseases of the nervous system.
• After traumatic brain or spine injury with spinal cord and lower limbs damage connected with paresis and paralysis, especially in quadriplegia condition (as a stage of rehabilitation process or permanent orthopedic support).

GENERAL CHARACTERISTICS OF STANDING FRAME

3.1. Standard equipment

1. Frame with castors equipped with brakes (2 back castors with friction brake)
2. Lower limbs separator
3. Adjustable pelvic support
4. Adjustable chest support
5. Pelvic harness

3.2. Additional equipment

SIZE TABLE

Symbol	Measurement	Unit	Size 1	Size 2	Size 3	Size 4	Size 5
A	pelvic support width	[cm]	26	28	31	37	42
B	pelvic support depth*	[cm]	22	25	27	29	35
C	pelvic support height	[cm]	44-60	66-82	77-102	85-112	98-120
	pelvic support circuit	[cm]	87	97	106	124	144
A1	chest support width	[cm]	26	28	31	37	42
B1	chest support depth	[cm]	22	25	27	29	35
C1	chest support height	[cm]	52-70	77-95	89-116	92-126	108-143
	maximum user weight	[kg]	25	40	60	80	95

Weight and dimensions of the device	Unit	Size 1	Size 2	Size 3	Size 4	Size 5
width	[cm]	59	60	63	66	74
length	[cm]	98	91	84	84	73
height	[cm]	54	79	90	96	112
weight	[kg]	13,5	16,5	18	20,5	23

* Measured without pelvic harness
Note: Dimensional tolerance in the table is: +1/-1 cm.

DESCRIPTION HOW TO ASSEMBLY STANDING FRAME

LIST OF ELEMENTS:

To assemble ACTIVAL™ you should:
STEP 1. Attach the columns (4) to the standing frame’s base (3). Columns should be fastened to the base in place of two holes by use of attached screws.

STEP 2. Attach the pelvic support (2) to the base (3). In order to do that, insert the pelvic brace brackets into the first frame of the base.

CAUTION! After assemble of the pelvic support and adjusting it at the desired height be sure to tighten the knobs!

STEP 3. Attach the chest support (1) to the base (3). In order to do that, insert the chest support brackets into the second frame of the base.

CAUTION! After assembling of the chest support and adjusting it at the desired height be sure to tighten the knobs!

DESCRIPTION HOW TO USE STANDING FRAME

CAUTION! The adjustment of standing frame to the patient should be always made by suitably trained staff. Suitably trained persons have to assist patient while doing exercises.
Before use of you should block the wheels’ brakes and standing frame unlock pelvic support and chest support Not blocking the wheels of standing frame can cause its shifting while uprising, which results in patient’s fall, breakage or body’s injury. During coming into standig frame or getting out of it you mustn’t rest on rear clamping-rings’ locks whilethey 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.

6.1. Chest Support
6.1.1. In order to adjust the height of the chest support, you should loosen the knobs and set the desired height. Afterwards tighten the knobs.

Height of chest support depends on patient’s control over his chest. If control is good, patient keeps upright position, it does not require his big effort and patient feels safe, the clampingring can be fixed below. Nevertheless, in such case a walking process should begin with fixing the clamping-ring under one’s arm and then you can gradually level down. To regulate the height of chest support use knobs A.

6.2. Pelvic Support
6.2.1 In order to adjust the height of the pelvic support, you should loosen the knobs and set the desired height.
Afterwards tighten the knobs.

6.2.2 Pelvic support can be adjusted
horizontally. In order to change the pelvic support depth, you should unscrew the knobs placed located under the support and set the desired position (so that the holes on the frames overlap). Afterwards tighten the knobs.

Pelvic support pelvic support should be fixed at the level of trochanter of lower limbs. After fixing height you must regulate position of (regulation forward and backward) 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 pelvic support and chest support you cannot exceed the double lines on cantilever.

6.3. Pelvic Harness
Pelvic harness protects the patient from falling out of the device. In order to attach it to the pelvic support, fasten the harness buckle on the pelvic support.

CAUTION! While buttoning buckles please place your attention on characteristic sound “CLICK” which informs about correct fastening.
CAUTION! Pelvis’ harness cannot be treated as a seat, it serves as a protection from the fall only in case of faintness!
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. The device is safe and will remain solid and stable even if patent loses his consciousness

6.4. Castors with friction brake
Using the castors with friction brake enables patient to fit the speed of moving in ACTIVALL™. It is of importance during the first exercises in dynamic standing frame. Knob A regulates strength of stress of a metal strip which brake the rotating castors. While first steps in ACTIVALL™ it is recommended to use friction brakein order to move slower. When patient gets more confidence, the resistance of break can be reduced.

LEARNING TO WALK

If the patient feels well you can unblock the brakes and start practicing. If the patient feels well you can unblock the brakes and start practicing. While using off-road version you should check if swapped chassis is suitable matched and fastened. Also check the brakes and their assembly.
By shoving the trunk and pelvis ahead, with both hands on handles (handles are additionally protected from sliding of hands and coated with washable spongy material) or on supports (ADDITIONAL EQUIPMENT). Then the equilibrium point will Shift forward, which stimulate walking process. This position should not be forced, because then can bring about the opposite effect.
The first steps should be done forward and then backward and finally to diverse directions.
While walking, firstly normal steps should be done and then fester or slower steps.
We recommend to use special paths in order to help in orientation for both courageous and not courageous type of patients.
After practicing in verticalizer ACTIVALL™ patient must return safely on wheelchair, chair, armchair, bed etc.

CAUTION! Patient cannot leave standing frame independently 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.
CAUTION! Construction assumptions involve operation of the standing frame on a smooth ground. It is forbidden to overcome obstacles like thresholds or other when the standing frame is loaded. Failure to
above recommendations may lead to feet separator damage (separator detachment or roller deflection). Damage caused by improper operation are not subject to warranty repair.

ADDITIONAL EQUIPMENT

8.1. Castors with blockade of reverse movement, AVL_011 
Using the movement is of great importance while first steps in the dynamic standing frame. Screwing tight the knob A blocks a bend of castors and patient can move forward only. castors with blockade of reverse

8.2. Castors with blockade of reverse movement, AVL_010
Using of castors with blockade of reverse movement is very usefull in learn walking when patients are start to walk. To unblock blockade please lift up a holdfast and push metal rim under the holdfast (fig 2 and 3). To block againg stick out a metal rim from under the holdfast (fig 1).

8.3. Forearm supports, AVL_112
Perfect for people with limited control of the upper body, provide additional side support.
You can order 1 or 2 pieces.

8.4. Lower limbs separator, AVL_145
Lower limbs separator prevents crossing of the legs during using of the dynamic function of the device.

8.5. Lower limbs stabilizer, AVL_144
Lower limbs stabilizer converts the standing frame into fully functional static version. Knee supports can be adjusted to the user’s height.

8.6. Belt for moving the patients AM-P, AVL_002 
Durable and ergonomic design greatly facilitates daily care of the patient. Belt has three comfortable and sturdy handles and strong plastic buckle.

8.7. Set of large wheels (125 mm), AVL_013
Large 125mm castors with bearings. Very quiet and extremely durable. Front castors with directional and reversing lock, rear castors with directional lock and brake.
NOTE: The set of castors increases the standing frame height by 6cm

8.8. Narrowing pad for chest/hip support, AVL_142/143
Cushions narrowing the chest/hip support provide additional stabilization of the trunk. Attached to the chest/hip support. They help to better fit the device to the user’s needs.. Cushions are fastened by use of Velcro straps.

8.9. Hip supporting harness, AVL_141
Harness stabilizing the hips is attached to the both side of hips support. It provides a proper stabilization of the pelvis and secures the user from falling down. Thanks to the special buckles it allows for the lower limb immobilizers/tutors assembly.

8.10. Lower limb immobilizer AM-TUD-KD, AVL_201
It prevents from knee hyperextension and is highly recommended in the rehabilitation process of the patient.

8.11. Lower limb immobilizer with kneecap protection AM-TUD-KD-02, AVL_202
Indicated for patients with lower limbs muscles weakness. It prevents from knee hyperextension and is highly recommended in the rehabilitation process of the patient.

8.12. Universal knee immobilizer AM-TUD-KD-03, AVL_203
It prevents from knee hyperextension and is highly recommended in the rehabilitation process of the patient.

8.13. Post-operative knee brace with polycentric 20° rom adjustment and kneecap support, AM-KD-AM/2R-02, AVL_204
Indicated for patients with lower limbs muscles weakness. It prevents from knee hyperextension and is highly recommended in the rehabilitation process of the patient.

8.14. Lower limb extension immobilizer OKD-03, AVL_205
It prevents from knee hyperextension and is highly recommended in the rehabilitation process of the patient.

8.15. Lower limb in 10° flexion immobilizer OKD- 03/10, AVL_206
It keeps the knee joint in moderate 10° flexion which prevents from knee hyperextension.

8.16. Lower limb in 20° flexion immobilizer OKD- 03/20, AVL_207
It keeps the knee joint in moderate 20° flexion which prevents from knee hyperextension.

8.17. Universal knee immobilizer OKD-01, AVL_208
It is fast, efficient and comfortable solution for the patient in the case of the knee joint instability.

8.18. Lower limb brace with polycentric 20° rom adjustment OKD-02, AVL_209
It stabilizes and reliefs the knee joint. Equipped with a 2R side clock that enables you to adjust the range of motion of the knee joint at 20°.

8.19. Post operative knee brace with polycentric 20° rom adjustment AMKD-AM/2R, AVL_210
It stabilizes and reliefs the knee joint. Equipped with a 2R side clock that enables you to adjust the range of motion of the knee joint at 20°.

8.20. Post operative knee brace with 15° rom adjustment AM-KD-AM/1R, AVL_211
It stabilizes and reliefs the knee joint. Equipped with a 2R side clock that enables you to adjust the range of motion of the knee joint at 15°.

8.21.Foot-drop brace with frontal plate equalization AM-ASS-OS, AVL_212
AFO type orthotics, perfect in the case of peroneal nerve palsy and feet paresis.

8.22. Kafo brace for lower limb with splints 2r and dynamic foot made of carbon fibre AM-KDS-AM/2R, AVL_213
KAFO type orthotics, stabilizes the knee joint and compensates for the lost flexion function.

8.23. Knee and hip orthosis with rom adjustment OKD-14 , AVL_216
The orthotics stabilizes the hip and knee joint in the frontal and sagittal plane.

8.24. The lower limb brace OKD-13, AVL_217
It allows for safe and independent movement of the patient e.g. from wheelchair to bed.

8.25. Dynamic lower limb brace raising the leg OKD-10, AVL_218
The orthotics activates the normal gait pattern by lifting and moving weakened lower limb.

THE USE OF STANDING FRAME

CAUTION! ACTIVALL™ 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 ACTIVALL™!

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, or thesis, shoes) if it is recommended by doctor.

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!

9.2. How to use standing frame
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.

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.

Patient cannot leave standing frame independently!
To leave ACTIVALL™ the following should be done (hints for doctors of rehabilitation):

1. Block the wheels of dynamic standing frame using brakes.
2. At the back of dynamic standing frame put the wheelchair, chair, armchair.
3. Unfasten opening of both pelot-pads.
4. Seat patient on wheelchair, chair, armchair etc gently.

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.

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!
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.

SAFETY RULES

CAUTION! Dynamic standing frame ACTIVALL™ has to be used in compliance with guidelines in this user manual.

It is highly important to consult either doctor or physiotherapist in order to make right decision concerning the choice of ACTIVALL™ and its size. It is also essential to familiarize with the guidelines described in user manual before using the device.

1. 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.
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.

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 9 where you will find information regarding this issue.

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)

MAINTENANCE AND CLEANING

ACTIVALL™ should be kept clean and used in compliance with the manufacturer’s recommendations. The device should be kept in clean, dry and ventilated room. Maintenance as well as cleaning have to be performed at least once a month. Regular cleaning and maintenance of device are indispensable to maintain its correct functionality as well as safety.
It is highly advisable to remember about proper maintenance in order to extend product’s aesthetics. So as to do that, it is essential to comply with these guidelines:

1. It is recommended to clean upholstery with the aid of cleaning product, soft sponge and warm water. If you use sponge which is too wet, stain may get bigger, upholstery may be destroyed. It is necessary to remember that the excess of dampness should be removed from fabric before next cleaning. Please rinse upholstery with warm water and clean white cloth once stain is removed.
2. It is forbidden to soak upholstery!
3. It is forbidden to clean upholstery with the aid of hard brushes.
4. It is forbidden to clean upholstery with strong chemical agents such as solvent or caustic chemicals.
   CAUTION! Akces-MED. Sp z o. o takes no responsibility for damages caused by use of wrong clearing agent.
5. It is forbidden to soak upholstery during cleaning. Remember that upholstery has to be always dry before using.
6. It is forbidden to clean, make any changes and maintain stroller during using it.
7. All metal as well as plastic elements should be cleaned by hand with the aid of general cleaning products. Remember to familiarize yourself with cleaning product’s leaflet.
8. Pelvic harness should be hand washed in water not exceeding 40°C, using mild detergents. After washing, dry it at room temperature.
9. In the case of using the standing frame by many patients in hospitals, rehabilitation wards or other places, and regulations of these facilities do not provide otherwise, the push handles should be  disinfected before passing the device to other patient.

CAUTION! Remember that upholstery has to be always dry before using!

Before using it is necessary to:

• clean wheels;
• check if base as well as wheels are correctly mounted; check if brake stops turning wheel
• make sure that all wooden parts e.g. tray don’t have splinters check if stroller construction is free of breaks or any kinds of deformities;
• check if all movable parts are working and all screws, nuts, knobs etc. are correctly tightened
• check if belts, vests, trunk belts, feet stabilizing belts etc are not frayed; check if buckles and clamps work correctly

CAUTION! Manufacturer takes responsibility only for hidden faults or damages which appeared despite the fact that user complied with the guidelines.
CAUTION! In case of any damages, it is essential to contact the person who sold you the product.

ORTHOPAEDIC DEVICES MANUFACTURER
Akces-MED Sp. z o.o. Jasionka 955B
36-002 Jasionka tel. (17) 864 04 77
www.akces-med.com
e-mail: export@akces-med.com
Authorised Dealer

Date of issue: 27.07.2007
The last update: 26.01.2016

Documents / Resources

AKCES MED ACTIVALL Dynamic Standing Frame [pdf] User Manual ACTIVALL Dynamic Standing Frame, ACTIVALL, Dynamic Standing Frame, Standing Frame, Frame

References

• User Manual