Ormesa Grillo Manual

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USE AND MAINTENANCE HANDBOOK
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front-drive
gait trainer
posterior
gait trainer

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TABLE OF CONTENTS
WARNINGS............................................................................................................................... 4
SOME EXAMPLES OF WHAT NOT TO DO WITH THE PRODUCT........................................ 6
LABELS AND PLATES............................................................................................................. 6
CONFORMITY DECLARATION................................................................................................ 7
GUARANTEE............................................................................................................................ 8
HOW TO STORE AND TRANSPORT THE MEDICAL DEVICE................................................ 8
WHAT GRILLO IS AND WHAT IT IS FOR................................................................................ 9
HOW GRILLO WORKS............................................................................................................. 9
HOW GRILLO IS COMPOSED ................................................................................................. 11
TECHNICAL SPECIFICATIONS - GRILLO GAIT TRAINER.................................................... 12
HOW TO USE GRILLO, FRONT DRIVE and POSTERIOR GAIT TRAINER............................ 16
FRAME: HEIGHT ADJUSTMENT .....................................................................................................16
PARKING BRAKES ..........................................................................................................................17
ADJUSTABLE BRAKE.....................................................................................................................18
ANTI-REVERSE DEVICE .................................................................................................................19
PELVIC SUPPORT ASSEMBLY .......................................................................................................20
PELVIC SUPPORT: HEIGHT ADJUSTMENT [sizes S and M] ..........................................................21
PELVIC AND THORACIC SUPPORTS: CIRCUMFERENCE ADJUSTMENT....................................22
DIRECTIONAL LOCKS.....................................................................................................................23
CHANGE GRILLO from POSTERIOR to FRONT-DRIVE GAIT TRAINER and VICE VERSA............24
HANDLES: ADJUSTMENTS in WIDTH.............................................................................................28
THORACIC SUPPORT ASSEMBLY .................................................................................................29
THORACIC SUPPORT: HEIGHT ADJUSTMENT .............................................................................30
THORACIC SUPPORT: FORWARD-BACKWARD and TILT ADJUSTMENTS..................................31
CHANGING size M PELVIC and TRUNK SUPPORTS WITH size S AND size L WITH size M..........33
ADJUSTMENTS FOR GRILLO FRONT-DRIVE GAIT TRAINER.............................................. 34
2/78

PELVIC HARNESS: ADJUSTMENT sizes M and L...........................................................................34
PELVIC HARNESS: ASSEMBLY sizes S, M and L ...........................................................................35
HANDLEBAR: HEIGHT, TILT, FORWARD-BACKWARD ADJUSTMENTS .......................................37
ADJUSTMENTS for GRILLO POSTERIOR GAIT TRAINER.................................................... 38
REMOVABLE GRIP HANDLES ........................................................................................................38
PELVIC HARNESS: ASSEMBLY AND ADJUSTMENT .....................................................................39
ASSEMBLING AND ADJUSTING THE COMPONENTS.......................................................... 40
ARM SUPPORTS .............................................................................................................................40
ARM STRAPS...................................................................................................................................44
LEG DIVIDER WITH TIGHT STRAPS...............................................................................................45
LEG DIVIDER ...................................................................................................................................48
FOLDING SEAT for GRILLO POSTERIOR GAIT TRAINER [sizes S and M].....................................50
LUMBAR SUPPORT for GRILLO POSTERIOR GAIT TRAINER [sizes S and M]..............................51
PUSH HANDLE for THE ASSISTANT [sizes S and M]......................................................................53
WEIGHT BARS.................................................................................................................................55
PEDALS for GRILLO PARKING BRAKES.........................................................................................56
PAIR of WHEELS for NARROW BASE with PARKING BRAKES PEDALS only for INDOOR USE [sizes
M and L]............................................................................................................................................59
SADDLE [sizes S and M] ..................................................................................................................62
ERGONOMIC HANDLES of GRILLO ................................................................................................68
MULTI ADJUSTABLE HEADREST ...................................................................................................70
ORDINARY AND EXTRAORDINARY MAINTENANCE............................................................ 72
1. ORDINARY MAINTENANCE (or preventive) ......................................................................72
2. EXTRAORDINARY MAINTENANCE (or corrective)............................................................75
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ASSISTANCE AND SPARE PARTS OF GRILLO .................................................................... 77
DISPOSAL ................................................................................................................................ 77
CONDITIONS FOR DURABILITY, REUSE AND REASSIGNMENT TO A NEW USER ........... 78
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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”.
-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 accessories 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 7

4/78


KDVWR perform 
 and  following the
instructions shown in the "Maintenance" chapter on page
72, 73, 74, 75, 76, 77 and  
 AT THE INTERVALS INDICATED to
VERIFY that it is WORKING PROPERLY and in GOOD
CONDITION, otherwise warranty will fail and marking
will lapse
PRODUCT  other than the regular
maintenance shown on page 72, 73, 74, 75, 76, 77 of
the manual must be ONLY MADE by a 
 in the maintenance of mechanical
aids for disables, otherwise warranty and marking
will be voided
Any in the product ARE 
. REFER ONLY TO ORMESA,
otherwise warranty and marking will be voided
The 
 ARE NOT
AUTHORIZED. REFER ONLY TO ORMESA, otherwise
warranty and marking will be voided
In case of  about the  of the product
or  to parts or components, you are urged to
 and
 in
the maintenance of mechanical aids for disables, or
directly ORMESA.
/78

SOME EXAMPLE
S
OF 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 ACCESSORIES 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


VUO
Via A. Da Sangallo, 1 06034 Foligno (PG) ITALY Tel. [phone] Fax [phone]
M O D E L . P A R T N °
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CONFORMITY DECLARATION
ORMESA S.r.l. GUARANTEES AND DECLARES, under its own exclusive
responsibility, that the following medical device, technical aid for
rehabilitation:


Which this declaration refers to, conforms with the general requirements provided
in the Directive 93/42/EEC and subsequent amendments and additions, concerning
the medical devices, according to which this aid belongs to the risk class I and has
been designed in observance to the following standards:
CEI EN ISO 14971:2012 Medical Devices - Application of risk
management to medical
EN 12182:2012 technical aids for disabled persons - general
requirements and test methods
EN 980:2009 Graphical symbols for use in the labelling of
medical devices
EN 1041:2009 Information supplied by the manufacture with
medical devices
ISO 9999:2011 Technical aids for persons with disabilities -
Classification and terminology
EN 1985 :2001 Walking aids. General requirements and test
methods
EN ISO ISO 11199-3:2005 Walking aids manipulated by both arms -
Requirements and test methods – Part 3:
Walking tables
EN UNI EN ISO11199-2:2005 Walking aids manipulated by both arms.
Requirements and test methods. Rollators
October 14, 2014 the Legal Representative
Luigi Menichini
7/78

GUARANTEE
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DFFHVVRULHV
ORMESA will not be liable for damage in the following cases:
-use by an unsuitable person;
-incorrect assembly of parts or accessories;
-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  and
the warningsRQSDJH
8/78

WHAT GRILLO IS AND WHAT IT IS FOR
GRILLO is a walking aid, that’s to say a product that was designed to help and make the
independent moving of a User easier. It is for spasthic/distonic users, for users who have
little brawn or for users who start to walk.
It was designed and made for the user to:
-walk without help when independent walking is impossible;
-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 simply the movement of a body in an upright
position from one point in space to another and it is possible by:
- the step pattern (alternate bending and stretching of each leg);
- maintaining the balance of the trunk and pelvis, first on both feet and then on one only
during the moving;
- awareness of space and distance.
GRILLO is used :
a) to generate 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 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 accessories 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.
9/78

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.
The support of the pelvis and the weight on his feet can be increased or decreased by
adjusting the harness 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. 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 difficult) 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.
-
10/78

HOW GRILLO IS COMPOSED
FRONT-DRIVE FRAME
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11/78

T
ECHNICAL SPECIFICATIONS
-
GRILLO GAIT TRAINER
 $YDLODEOH LQ 3 SIZES S, M and L DQG 2 MODELS (GRILLO Frontdrive and
Posterior gait trainer).
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PELVIC SUPPORT and THORACIC SUPPORT,SDGGHGLQGHSHQGHQWO\DGMXVWDEOHLQ
KHLJKW ZLGWK DQG FLUFXPIHUHQFH DOORZ DQ HDV\ DFFHVV WKDQNV WR WKH EDFN RSHQLQJ
7KH\ hold the user just like two hands DQG WKLV JLYHV KLPKHU DVHQVHRI VHFXULW\
DQGVWDELOLW\DOORZLQJWKHXVHUWRFRQFHQWUDWHRQO\RQZDONLQJZLWKRXWDQ\IHDU
GRADUATED BARS DVDUHIHUHQFHRQKHLJKWDGMXVWPHQWV
PELVIC HARNESS,  HUJRQRPLF FRPIRUWDEOH DGMXVWDEOH DQG HDVLO\ UHPRYDEOH IRU
ZDVKLQJ ,W VXSSRUWV WKH XVHUV LQ FDVH RI QHFHVVLW\ ZLWKRXW JHQHUDWLQJ SDLQIXO
SUHVVXUHV
HANDLEBARUHPRYDEOHDQGDGMXVWDEOHLQKHLJKWLWLVXVHGDVDUHIHUHQFHDQGDVDQ
DUPUHVW
 $GMXVWDEOHHANDLES.
ARM SUPPORTSDGMXVWDEOHLQKHLJKWWLOWLQJURWDWLRQDQGGHSWK
LUMBAR SUPPORT.
 0DQXDOO\FOLDABLE SEAT.,WJLYHVDVXSSRUWLQFDVHRIQHHG
SADDLEDGMXVWDEOHLQKHLJKWDQGIROGDEOH
 ([FOXVLYH ORMESA DESIGN WHEELS OLJKW DQG SXQFWXUHSURRI  IURQW VZLYHOLQJ
VL]H6DQGFPVL]H0DQG/DQGUHDUIL[HGFP6DQGFP
VL]H0DQGVL]H/
DIRECTIONAL LOCKSRQIURQWZKHHOV
ADJUSTABLE BRAKES.
ANTIREVERSE DEVICE.
WHEEL STOP.
UPHOLSTERIES EUHDWKDEOHDQGUHPRYDEOHIRUZDVKLQJ
SEMI-ELASTIC BUFFERS RQIURQWZKHHOVWRSURWHFWDJDLQVWEXPSV
LEG DIVIDER DYRLGVDGGXFWLRQDQGKHOSVWRIROORZWKHULJKWJDLWSDWWHUQ


PUSH HANDLE FOR THE ASSISTANT
WEIGHT BARS. They make the aid heavier according to the size:*ULOOR6NJ/EV
[*ULOOR0DQG/NJ/EV[
USER HEIGHT (C):
FP*5,//26
FP*5,//20
FP*5,//2/
IMPORTANT:
0DNHVXUHWKDWPHDVXUHV$DQG%LQGLFDWHGLQWKHILJXUHGR
QRWH[FHHGWKHVXJJHVWHGUDQJHLQGLFDWHGIRUWKHVXSSRUWV
VHHSDJHVDQG
PEDALS for PARKING BRAKES
PAIR OF REAR WHEELS NARROW BASE IRUVL]H0DQG/

User dimensions
A
B
C
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DIMENSIONS in cm
,QQHU circumferenceRIWKHDGMXVWDEOH
pelvic and thoracic VXSSRUWV
GRILLO FRONT-DRIVE WALKER size S  :(,*+7NJ0$;/2$'NJ
,QQHU circumferenceRIWKHDGMXVWDEOH
pelvic VXSSRUW
GRILLO POSTERIOR WALKER size S :(,*+7NJ0$;/2$'NJ
HYPHEN-SEPARATED NUMBERS INDICATE THE MINIMUM AND MAXIMUM RANGE OF ADJUSTMENT
IURPFPWRFP
IURPFPWRFP
13/78

DIMENSIONS in cm ,QQHU circumferenceRIWKHDGMXVWDEOH
pelvic and thoracic VXSSRUWV
GRILLO FRONT-DRIVE WALKER size M :(,*+7NJ0$;/2$'NJ
,QQHU circumferenceRIWKHDGMXVWDEOH
pelvic VXSSRUW
GRILLO POSTERIOR WALKER size M :(,*+7NJ0$;/2$'NJ
HYPHEN-SEPARATED NUMBERS INDICATE THE MINIMUM AND MAXIMUM RANGE OF ADJUSTMENT
IURPFPWRFP
IURPFPWRFP
14/78

DIMENSIONS in cm ,QQHU circumferenceRIWKHDGMXVWDEOH
pelvic and thoracic VXSSRUWVIURPFPWRFP
GRILLO FRONT-DRIVE WALKER size L :(,*+7NJ0$;/2$'NJ
,QQHU circumferenceRIWKHDGMXVWDEOH
pelvic VXSSRUW
GRILLO POSTERIOR WALKER size L :(,*+7NJ0$;/2$'NJ
HYPHEN-SEPARATED NUMBERS INDICATE THE MINIMUM AND MAXIMUM RANGE OF ADJUSTMENT
IURPFPWRFP
IURPFPWRFP
15/78

HOW TO USE GRILLO, FRONT DRIVE and POSTERIOR
GAIT TRAINER
FRAME: HEIGHT ADJUSTMENT
1- 23(5$7(7+($'-8670(17.12%6:,7+%27++$1'6
2- $'-8677+(+(,*+72)*5,//25(/($6,1*7+($'-8670(17.12%6
KHLJKWDGMXVWPHQW
QXPEHUHGEDUV
KHLJKWDGMXVWPHQW
QXPEHUHGEDUV
SUHVVEXWWRQV
KHLJKWDGMXVWPHQW
QXPEHUHGEDUV
6L]H6
6L]HV0
DQG/
16/78

PARKING BRAKES
EUDNHOHYHU
)5((:+((/ /2&.(':+((/
17/78

ADJUSTABLE BRAKE
/2&.(':+((/
)5((:+((/
326,7,2162)7+(
$'-867$%/(%5$.(6
$'-867$%/(%5$.(/(9(5
18/78