Ormesa Grillo Manual

INGLESE - Cod.22850 - 01-07-21
ˈˆʸʴˁʷˀʴʼˁˇʸˁʴˁʶʸʻʴˁʷʵ˂˂ʾ
front drive
gait trainer
rear drive
gait trainer

Pag. 1 of 77
ORMESA thanks you for the confidence placed in choosing our GRILLO gait trainer.
GRILLO is a medical device designed and manufactured by ORMESA srl.
ORMESA then suggests you to read this handbook very carefully. It will help you in
becoming familiar with GRILLO soon and more efficaciously, and you will also find many
practical pieces of advice to use it safely and in the best possible way and to keep it
perfectly efficient.
In the end, should you still have something to ask for or to clear, don't hesitate to contact
your Dealer, who will be glad to give you all the necessary assistance, or directly call
ORMESA. Our phone number is [phone], our fax number is [phone]
and our E-mail is: info @ormesa.com.
Ormesa Team

Page 2 of 77
TABLE OF CONTENTS
WARNINGS ............................................................................................................................... 4
WHAT NOT TO DO WITH THE PRODUCT .............................................................................. 6
LABELS AND PLATES............................................................................................................. 6
GUARANTEE ............................................................................................................................ 7
HOW TO STORE AND TRANSPORT THE MEDICAL DEVICE................................................ 7
WHAT GRILLO IS AND WHAT IT IS FOR. INTENDED USE.................................................... 8
HOW GRILLO WORKS ............................................................................................................. 8
HOW GRILLO IS COMPOSED ................................................................................................. 10
TECHNICAL SPECIFICATIONS - GRILLO GAIT TRAINER.................................................... 11
HOW TO USE GRILLO, FRONT DRIVE and REAR DRIVE GAIT TRAINER ........................... 15
FRAME: HEIGHT ADJUSTMENT ........................................................................................................... 1 5
PARKING BRAKES ................................................................................................................................. 16
ADJUSTABLE BRAKE............................................................................................................................ 17
ANTI ROLLBACK DEVICE ...................................................................................................................... 18
PELVIC SUPPORT ASSEMBLY ............................................................................................................. 19
PELVIC SUPPORT: HEIGHT ADJUSTMENT [sizes S and M].............................................................. 20
PELVIC AND THORACIC SUPPORTS: CIRCUMFERENCE ADJUSTMENT ...................................... 21
DIRECTIONAL LOCKS............................................................................................................................ 22
CHANGE GRILLO from REAR DRIVE to FRONT-DRIVE GAIT TRAINER and VICE VERSA............ 23
HANDLES: ADJUSTMENTS in WIDTH .................................................................................................. 27
THORACIC SUPPORT ASSEMBLY ....................................................................................................... 28
THORACIC SUPPORT: HEIGHT ADJUSTMENT .................................................................................. 29
THORACIC SUPPORT: FORWARD-BACKWARD and TILT ADJUSTMENTS .................................... 30
CHANGING size M PELVIC and TRUNK SUPPORTS WITH size S AND size L WITH size M .......... 32
ADJUSTMENTS FOR GRILLO FRONT-DRIVE GAIT TRAINER .............................................. 33
PELVIC HARNESS: ADJUSTMENT sizes M and L ............................................................................... 33
PELVIC HARNESS: ASSEMBLY sizes S, M and L ............................................................................... 34
HANDLEBAR: HEIGHT, TILT, FORWARD-BACKWARD ADJUSTMENTS ......................................... 36

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ADJUSTMENTS for GRILLO REAR DRIVE GAIT TRAINER ................................................... 37
REMOVABLE GRIP HANDLES .............................................................................................................. 37
PELVIC HARNESS: ASSEMBLY AND ADJUSTMENT ......................................................................... 38
ASSEMBLING AND ADJUSTING THE ADDITIONAL COMPONENTS ................................... 39
ARM SUPPORTS .................................................................................................................................... 39
ARM STRAPS .......................................................................................................................................... 43
LEG DIVIDER WITH TIGHT STRAPS .................................................................................................... 44
DISTAL ABDUCTOR .............................................................................................................................. 47
FOLDING SEAT for GRILLO REAR DRIVE GAIT TRAINER [sizes S and M] ...................................... 49
LUMBAR SUPPORT for GRILLO REAR DRIVE GAIT TRAINER [sizes S and M] ............................... 50
PUSH HANDLE for THE ASSISTANT [sizes S and M] .......................................................................... 52
WEIGHT BARS ........................................................................................................................................ 54
PAIR of WHEELS for NARROW BASE with PARKING BRAKES PEDALS only for INDOOR USE [sizes
M and L].................................................................................................................................................... 55
PROXIMAL ABDUCTOR [sizes S and M] ............................................................................................... 57
ERGONOMIC HANDLES of GRILLO...................................................................................................... 62
MULTI ADJUSTABLE HEADREST ......................................................................................................... 64
ERGONOMIC SADDLE ........................................................................................................................... 66
MAINTENANCE ........................................................................................................................ 67
1. ORDINARY MAINTENANCE (monthly) ........................................................................ 67
2. PREVENTIVE MAINTENANCE (biennial) .................................................................... 71
3. EXTRAORDINARY MAINTENANCE (or corrective) ................................................ 72
CLEANING, DISINFECTION, SANITIZATION .......................................................................... 73
INFORMATION ........................................................................................................................................ 73
WARNINGS .............................................................................................................................................. 73
PROCEDURE .......................................................................................................................................... 74
ASSISTANCE AND SPARE PARTS OF GRILLO .................................................................... 76
DISPOSAL ................................................................................................................................ 76
CONDITIONS FOR DURABILITY, REUSE AND REASSIGNMENT TO A NEW USER ........... 77

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WARNINGS
- Before using the aid carefully read the instructions in this handbook because it was
written for your safety and to guide you in the necessary learning process of the right use and
Maintenance of this product. It is integrant part of the product and it must be kept with care
for future references.
- This handbook is for Dealers, Retailers Assistants and Users; it gives instructions about
the correct use of the product and it has to be integrated by an adequate knowledge of the aid
by the prescribing specialist.
- The handbook reflects the state of technique at the moment of taking the aid into the
market. ORMESA srl reserves the right to carry out any modification to the aid and to its
handbook which can be suggested by the experience, by technical considerations or
by the change of standards. These modifications will be made without being obliged to
update the previous production and its handbooks.
- The use of the gait trainer and its additional parts must be checked by qualified
personnel , according to the laws, rules and regulations in force.
- GRILLO can be only used by people who have well read the instructions specified in
this handbook.
- Training for the use of GRILLO must be carried out in rehabilitation centres with the
help of qualified personnel.
- The walking frame has to be used by people whose body size and weight are just like
the ones specified in the paragraph “TECHNICAL SPECIFICATIONS”.
- DO NOT use the pelvic and thoracic supports as a support point while transferring the User
from the sitting to the standing position and vice versa. The components are in fact destined
to be used as anatomical supports in the walking phase. Use the HANDLES for the patient
transfer
- Before each use check that all adjustable parts are well locked.
- Always lock brakes when you stop, even on flat ground.
- Always lock brakes before adjusting any part.
- Always make sure that there are no obstacles which could cause GRILLO to tip
up, such as mats, steps and different objects on the floor. Beware of dangerous
points and obstacles in the area of use. Remove any knick-knacks or objects
which could be knocked down while using GRILLO.
- Avoid areas near unprotected artificial or natural water basin and water
courses.
- Always lock brakes when parking, even on flat ground, and before making any
adjustments
- Before each use always check that the components and the green levers for the
adjustments are effectively locked
- Before each use always check the effectiveness of brakes, the wear of the
wheel, the effectiveness of the green lever locking and in general of all those
parts that can loosen by the time and use. Should you notice a loss of efficacy ,
please contact your ORTHOPAEDIC WORKSHOP following the directions on
maintenance at pages 67, 68, 69, 70, 71, 72, 73, 74, 75, 76.

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GRILLO IS A MECHANICAL MEDICAL DEVICE:
THE USER has to perform REGULAR
MAINTENANCE and CLEANING following the
instructions shown in the "Maintenance" chapter on page
67,68, 69, 70, 71, 72, 73, 74,75, 76 and HAVE THE
DEVICE INSPECTED AT THE INTERVALS
INDICATED to VERIFY that it is WORKING PROPERLY
and in GOOD CONDITION, otherwise warranty will fail
and marking will lapse
PRODUCT REPAIRS other than the regular
maintenance shown on page 67,68, 69, 70, 71, 72, 73,
74,75, 76 of the manual must be ONLY MADE by a
SPECIALIZED SERVICE CENTER in the
maintenance of mechanical aids for disables, otherwise
warranty and marking will be voided
Any CHANGES in the product ARE NOT
AUTHORIZED. REFER ONLY TO ORMESA,
otherwise warranty and marking will be voided
The REPLACEMENT WITHOUT ORIGINAL
PARTS OR COMPONENTS ARE NOT
AUTHORIZED. REFER ONLY TO ORMESA, otherwise
warranty and marking will be voided
In case of DOUBT about the SAFETY of the product
or DAMAGE to parts or components, you are urged to
IMMEDIATELY DISCONTINUE USE and
CONTACT a SPECIALIZED SERVICE CENTER in
the maintenance of mechanical aids for disables, or
directly ORMESA.

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-
WHAT NOT TO DO WITH THE PRODUCT
-GRILLO MUSTN'T BE USED UNLESS A MEMBER OF THE USER’S FAMILY OR
QUALIFIED PERSON IS PRESENT AT ALL TIME
-DO NOT CARRY OUT ANY OPERATION OR MANOEUVRE UNLESS YOU ARE
SURE OF THE RESULT: IF IN DOUBT, CONTACT YOUR NEAREST
TECHNICAL SERVICE OR CONTACT THE MANUFACTURER DIRECTLY
-GRILLO MUST BE USED BY PEOPLE WHOSE HEIGHT AND WEIGHT ARE
SUFFICIENT TO CONTROL ITS MOVEMENTS
-NEVER INSERT COMPONENTS OR COMPONENTS ON THE DEVICE
WITHOUT FOLLOWING THE INSTRUCTIONS GIVEN IN THE HANDBOOK
-DO NOT ADJUST THE FRAME AND THE COMPONENTS IN EXTREME
POSITIONS IN ORDER NOT TO PREJUDICE THE STABILITY AND SAFETY OF
THE DEVICE
-NEVER USE GRILLO ON UNEVEN GROUND, STEEP SLOPES OR STAIRS
-NEVER ALLOW UNKNOWN PEOPLE TO USE GRILLO
-NEVER LEAVE THE USER UNATTENDED WHILE USING GRILLO
-NEVER LEAVE GRILLO ON A SLOPE
-NEVER LIFT THE AID TO MOVE IT WHILE THE USER IS ON IT
-AVOID EXCESSIVE SPEED OF MOVEMENT TO GUARANTEE STABILITY AND
SAFETY OF THE DEVICE
-NEVER USE GRILLO IF THERE ARE DAMAGED OR MISSING PARTS
LABELS AND PLATES
Name of the model Series number Catalog code
Date of Medical
deviceproduction
LOT code Warning! Read the use and
maintenance handbook before use
Max. load
Conformity with the European
safety standards
Via A. Da Sangallo, 1 06034 Foligno (PG) ITALY Tel. [phone] Fax [phone]
MODEL.
LOT SN
MAX. KG
!
REF
MD
THE CE MARKING CERTIFIES THAT GRILLO CONFORMS TO THE SAFETY
REQUIREMENTS defined with the REGULATION (EU) 2017/745 OF THE EURO-
PEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 applicable for MEDI-
CAL DEVICE

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GUARANTEE
ORMESA warrants the product for 2 years; in case of problems, contact the retailer where
you purchased it. Always ask for original parts and components.
ORMESA will not be liable for damage in the following cases:
- use by an unsuitable person;
- incorrect assembly of parts or components;
- unauthorized modifications or service;
- use of other than original replacement parts and parts subject to wear (upholstery, wheels,
etc);
- improper use (such as, transporting objects or loads larger or heavier than those shown in
the instruction manual);
- damage caused by incorrect use and lack of regular maintenance, as shown in the
instruction manual;
- exceptional events;
- failure to follow the instructions in this manual.
THE GUARANTEE DOES NOT COVER WEAR PARTS, which are subject to wear and tear,
such as the upholsteries and the wheels.
HOW TO STORE AND TRANSPORT THE MEDICAL
DEVICE
THE DEVICE MUST BE STORED AND PACKED using the Ormesa original
packaging materials. THE AID MUST BE ALWAYS ACCOMPANIED BY THE
PRESENT HANDBOOK unless the guarantee will be voided.
- Once unpacked, THE TRANSPORT OF THE DEVICE must be done by ANCHORING
IT ADEQUATELY to the vehicle.
- When travelling by plane, or by car, DO NOT SUBJECT THE FOLDED FRAME TO
LOADS THAT, especially with road bumps, COULD DAMAGE ITS STRUCTURE.
THE DEVICE MUST BE PARKED / STORED IN CLOSED AND DRY PLACES
- The operating environment has no particular influence on the device unless it is
used incorrectly, such as by leaving it parked for a long time in direct sunlight or
exposed to bad weather such as rain, or in marine environments, where the salt
air could corrode the paint and the sliding parts. In this case, we recommend to
clean and dry the frame carefully following the instructions shown in the
“Maintenance and Cleaning” chapter on pages 67, 68, 69, 70, 71, 72 ,73, 74, 75, 76
and the warnings on page 73.

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WHAT GRILLO IS AND WHAT IT IS FOR. INTENDED USE
GRILLO is a gait trainer, that’s to say a product that was designed to help and make the
independent moving of a User easier. The intended use is for spasthic/distonic users, for
subjects with hyposthenia and/or exhaustion of the antigravity response, to subjects
with difficulty in coordination and motor control, and to subjects beginning to ambulate.
It was designed and made for the user to:
-walk without help when independent walking is impossible or not safe enough;
-train and start the walking process so that it may be continued without the aid at a
future stage. It can be used to practice the actions of walking or simply as a
permanent mean of moving around.
We remind that the process of walking is the movement of a body in an upright position
from one point in space to another and it is possible by:
-Supporting reaction, ahead of the force of gravity, even if exhaustible
- maintaining the balance of the trunk and pelvis, first on both feet and then on one only
during the moving
-awareness of peripersonal space
-Central Pattern Generator,capable of generating rhythmic patterns of motor activity
GRILLO is used :
a) to elicit and help the step pattern;
b) to train in maintaining balance of the trunk and pelvis;
c) to organize a wider structured vision of space, distance and the User's
surroundings in the upright position;
d) to enable the user to plan "projects" and "actions" , for example having the
possibility to see an object, think of its use, work the movement out to reach
the object and use it ;
e) to develop physical self-sufficiency and psychological independence by
experimenting the possibility of acting alone.
HOW GRILLO WORKS
Grillo compensates the user’s lack of balance and support thanks to its ergonomic support and
wide base, it allows the user to concentrate his/her residual abilities on walking.
The wide range of components and supports offer maximum versatility.
All components are interchangeable quickly and without the use of tools to suit different clinical
pictures.
Adequate training to use it must be given at a rehabilitation centre.
The following information will ensure the best way to use this aid.
Adjustment of the aid
Insert wheel stop
As soon as the User is into the aid, the supports must be closed and the straps must be
fastened. The following heights must be adjusted:
-the frame height
-the thoracic support height
-the pelvic support height
-the harness height
These adjustments must be made before positioning the user according to the anatomical
measures taken.
Once the User has been positioned, you can proceed with a micro adjustment until the optimal
setting is reached.

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There is no predetermined position!
Each position must be decided according to the User and it must be modified according to his
physical development, to the change in his motory situation and rehabilitation programme.
The pelvic support should be adjusted around the higher part of the pelvis at the height
of the upper, anterior and posterior iliac spines.
The support of the pelvis and the weight on his feet can be increased or decreased by
adjusting the harness height or ergonomic saddle height.
The height of the thoracic support is usually adjusted according to the child's ability to control
his trunk. If the User has a sufficient trunk control, the chest support may be removed.
THE NEXT STEP IS TO ADJUST THE CORRECT LINE-UP OF THE TWO SUPPORTS ON
VERTICAL AND TEST PLANE. THIS IS AN IMPORTANT AND DELICATE OPERATION
BECAUSE THE CORRECT POSITIONING OF THE TRUNK ON THE PELVIS DEPENDS ON
IT. Use the locking levers to position the thoracic support and move the support backwards or
forwards.
THE IDEAL POSITION TO LOOK FOR IS THE ONE WHICH LINES SHOULDERS, TRUNK
AND HIPS UP.
By pushing the thoracic support further forward as regards to the pelvic support and by
putting the hands on the handlebar, the trunk is moved forwards, thus stimulating
walking. This position must not be forced, otherwise it might have the opposite effect.
The handlebar must be adjusted depending on how much the User has to bend or straighten
his arms in order to push and guide GRILLO.
WHEN THESE OPERATIONS ARE COMPLETED, GRILLO CAN BE USED AS DESCRIBED
BELOW.
First of all it is important to know the aid and how to use it.
Children are not usually afraid to use the aid. On the contrary they are often extremely pleased
and happy and they want to move in all directions. These "rash" children must not be prevented
from doing so. In fact they should be encouraged. In the first days it is a good idea to let the
child use GRILLO freely so that he can try the different ways of using it.
For "fearful" children who are afraid to use GRILLO (probably due to problems of perception
which make awareness of space and distance altered) it is better to start its use in a different
way.
In his first steps the User mustn't be left alone, but he must be accompanied by qualified
personnel either therapist or parent who will stand either in front or to one side and will move
GRILLO slowly and gently.
This gives the User a feeling of safeness particularly if the therapist or parent speaks to him at
the same time and explains what they are doing (for instance, "now we are going towards the
table, we are reaching the TV, we are going to get the ball on the table, we are going back ...")
The first steps are always made forwards, then backwards and finally sideways.
At first walking will be at a constant speed, then a change in step will be asked for so that speed
will be faster or slower.
We suggest to follow well defined paths specifically designed to help orientate both "rash" and
"fearful" Users.
For those children who cannot easily walk, it is better to position the thoracic support
forwards respect to the pelvic support in order to get the flexion of the trunk. In this way
it will be easier to start moving the lower limbs.
-

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HOW GRILLO IS COMPOSED
FRONT-DRIVE FRAME
pelvic support
harness support
thoracic support
handlebar
anterior wheels with
directional locks
posterior wheels with
-pedal parking brake
-adjustable brake
-anti-reverse wheel stops
arm supports
handrests
pelvic support
harness support
REAR DRIVE FRAME
posterior wheels with
-pedal parking brake
-adjustable brake
-anti-reverse wheel stops
anterior wheels with
directional locks
height adjustment
numbered bars
height adjustment
numbered bars

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TECHNICAL SPECIFICATIONS - GRILLO GAIT TRAINER
§Available in 3 SIZES [S, M and L] and 2 MODELS (GRILLO Front drive and REAR
DRIVE gait trainer).
§ALUMINIUM FRAME, foldable for easy transportation and with PATENTED
HEIGHT-ADJUSTMENT SYSTEM.
§PELVIC SUPPORT and THORACIC SUPPORT, padded, independently adjustable
in height, width and circumference; allow an easy access thanks to the back
opening. They hold the user just like two hands and this gives him/her a sense of
security and stability allowing the user to concentrate only on walking without any
fear.
§GRADUATED BARS as a reference on height adjustments.
§PELVIC HARNESS, ergonomic, comfortable, adjustable and easily removable for
washing. It supports the users in case of necessity without generating painful
pressures.
§HANDLEBAR removable and adjustable in height, it is used as a reference and as
an armrest.
§Adjustable HANDLES.
§ARM SUPPORTS, adjustable in height, tilting, rotation and depth.
§LUMBAR SUPPORT.
§Manually FOLDABLE SEAT. It gives a support in case of need.
§PROXIMAL ABDUCTOR adjustable in height and foldable.
§Exclusive ORMESA DESIGN WHEELS, light and puncture-proof: 2 front swiveling,
Ø15 (size “S”) and cm 17,5 (size “M” and “L”) and 2 rear fixed, Ø cm 20 [size “S”]
and Ø cm 25 [size “M” and size “L”].
§DIRECTIONAL LOCKS on front wheels.
§ADJUSTABLE BRAKES.
§ANTIREVERSE DEVICE.
§PEDAL PARKING BRAKE
§SEMI-ELASTIC BUFFERS on front wheels to protect against bumps.
§LEG DIVIDER avoids adduction and helps to follow the right gait pattern.
§PUSH HANDLE FOR THE ASSISTANT
§WEIGHT BARS. They make the aid heavier according to the size: Grillo S + 2,6 kg.
(Lbs. 5.7) x2, Grillo M and L+ 3,4 kg. (Lbs. 7.5) x 2
§PAIR OF REAR WHEELS NARROW BASE [for size M and L]
USER HEIGHT (C):
cm 90 -135 GRILLO S
cm 110-165 GRILLO M
cm 160-190 GRILLO L
IMPORTANT:
Make sure that measures A and B indicated in the figure do
not exceed the suggested range indicated for the supports
(see pages 13,14 and 15)
User dimensions
A
B
C

DIMENSIONS in cm
Inner circumference of the adjustable
pelvic and thoracic supports, from 60 cm to 86 cm
GRILLO FRONT-DRIVE size S WEIGHT 19 kg MAX. LOAD kg 45
Inner circumference of the adjustable
pelvic support, from 60 cm to 86 cm
Page 12 of 77
GRILLO REAR DRIVE size S WEIGHT 18,5 kg MAX LOAD. kg 45
HYPHEN-SEPARATED NUMBERS INDICATE THE MINIMUM AND MAXIMUM RANGE OF ADJUSTMENT

Page 13 of 77
DIMENSIONS in cm Inner circumference of the adjustable
pelvic and thoracic supports, from 74 cm to 120 cm
GRILLO FRONT-DRIVE size M WEIGHT 22,5 kg MAX. LOAD kg 90
Inner circumference of the adjustable
pelvic support, from 74 cm to 120 cm
GRILLO REAR DRIVE size M WEIGHT 21,7kg MAX LOAD. kg 90
HYPHEN-SEPARATED NUMBERS INDICATE THE MINIMUM AND MAXIMUM RANGE OF ADJUSTMENT

Page 14 of 77
DIMENSIONS in cm
Inner circumference of the adjustable
pelvic and thoracic supports, from 81 cm to 140 cm
GRILLO FRONT-DRIVE size L WEIGHT 29.5 kg MAX. LOAD kg 110
Inn er circumference of the adjustable
pelvic support, from 81 cm to 140 cm
GRILLO REAR DRIVE size L WEIGHT 28.5 kg MAX LOAD. kg 110
HYPHEN-SEPARATED NUMBERS INDICATE THE MINIMUM AND MAXIMUM RANGE OF ADJUSTMENT

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HOW TO USE GRILLO, FRONT DRIVE and REAR DRIVE
GAIT TRAINER
FRAME: HEIGHT ADJUSTMENT
1- OPERATE THE ADJUSTMENT KNOBS WITH BOTH HANDS
2- ADJUST THE HEIGHT OF GRILLO RELEASING THE ADJUSTMENT KNOBS
press-buttons
height
adjustment
numbered
bars
height
adjustment
numbered bars
height
adjustment
numbered bars
Size S
Sizes
M and L

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PARKING BRAKES
Release lever
PEDAL brake
LOCK UNLOCK

Page 17 of 77
ADJUSTABLE BRAKE
5 POSITIONS OF THE
ADJUSTABLE BRAKES
ADJUSTABLE BRAKE LEVER
POSITION ZERO
FREE WHEEL
POSITION FOUR
WHEEL LOCKED

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AI RA DEVICE
WARNINGS!
The anti-reverse device reduces the maneuverability of the gait trainer
ANTI ROLLBACK
LEVER
DISACTIVATED
ANTI ROLLBACK
ACTIVATED
ANTI ROLLBACK
ANTI