1. GENERAL INFORMATIONS ..................3 1.1 THANKS FOR CHOOSING THE MEDICAL DEVICE ..............3 1.2 CONTACT DETAILS FOR ASSISTANCE .................. 3 1.3 CONTACT DETAILS FOR INCIDENT OR NEAR INCIDENT ............3 1.3 PACKAGING INFORMATION. UNPACKING INSTRUCTIONS AND SUPPLY COMPOSITION ..4 1.4 MECHANICAL AND DIMENSIONAL CHARACTERISTICS ............
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LEGREST ADJUSTMENT ..................... 32 FOOTRESTS ADJUSTMENT ....................34 5.4 ADJUSTMENT AND CONFIGURATION OF THE ADDITIONAL COMPONENTS by the health professional ........................35 POSTURAL HEADREST 863 ....................35 ERGONOMIC HEADREST 942 .................... 37 HEADREST 835 and 865 ....................39 HEADREST with PARIETAL PROTECTIONS 852 ..............40 TRUNK SIDE SUPPORTS 838 ....................
It will help you familiarize yourself earlier and more effectively with GRILLO Postural System, but not only that, because you will find several practical tips on how to use it in the best and safest way and how to keep it in perfect working order at all times..
SIZE SMALL 0.502 SIZE MEDIUM HOW TO TAKE GRILLO POSTURAL SYSTEM OUT OF THE BOX CAUTION! CUT WITHOUT PRESSING TOOT HARD WITH THE BLADE SO AS NOT TO DAMAGE THE CONTENTS OF THE BOX. TAKE THE ACCESSORIES OUT OF THE BOX...
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SUPPLY COMPOSITION Grillo Postural System - Seat Unit Grillo Postural System - External Base Allen key Use and maintenance handbook Pag. 5/72...
1.5 MECHANICAL AND DIMENSIONAL CHARACTERISTICS Measures in cm, weight in kg 0° ANGLE ADJUSTABLE PUSH-HANDLE STROLLER CLOSED WITH STROLLER CLOSED SEAT REMOVED WITH SEAT ATTACHED User height size mini cm 75 - 100 User height size S cm 90 -120 User height size M cm 115 - 140 SIZE MINI...
1.6 PRODUCT PARTS LEGEND HANDLEBAR BACKREST HEADREST UPHOLSTERY ARMRESTS SEAT LEGREST FOOTRES T FRAME FRONT WHEEL WITH DIRECTION LOCKS REAR WHEELS WITH PEDAL BRAKE SHOULDERS LATERAL SUPPORT Pag. 7/72...
Dry horizontally environment after use 1.8 IDENTIFICATION PLATE THE CE MARKING CERTIFIES GRILLO POSTURAL SYSTEM CONFORMS TO THE SAFETY REQUIREMENTS defined with the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 applicable for MEDICAL DEVICE...
2. LEGAL AND REGULATORY REFERENCES 2.1 LEGAL REFERENCES Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, repealing Council Directive 93/42/EEC, hereinafter also referred to as "Regulation (EU) 745/2017", or "RDM" 2.2 REGULATORY REFERENCES HARMONIZED STANDARDS UNI CEI EN ISO...
Wheelchairs - part 22: set-up p rocedures 2.3 WARRANTY CONDITIONS ORMESA warrants the product for 2 years: in case of problems, contact the supplier (health professional) where you purchased it. Always ask for original spare parts, otherwise the guarantee will decline.
HEALTH PROFESSIONALS, CARERS (CARE GIVERS) PATIENTS; It provides instructions for the correct use of the medical device. - The manual reflects the technical state of the product at the time it was sold. ORMESA S.R.L. RESERVES THE RIGHT TO MAKE ANY CHANGES TO THE PRODUCT OR MANUAL suggested by experience, technical considerations or regulatory developments.
3.4 REASONABLY FORESEEABLE MISUSE - DO NOT USE THE MEDICAL DEVICE WITH SUBJECTS WITH DIMENSIONS GREATER THAN those indicated on pag. 6. - DO NOT USE THE MEDICAL DEVICE ON ACCIDENTED GROUND NEAR STRONG SLOPES OR STAIRS. - NEVER LEAVE THE USER ALONE in the medical device. - DO NOT ALLOW CHILDREN TO USE THE PRODUCT, NOT EVEN FOR PLAYING - DO NOT PLACE EXCESSIVELY HOT LIQUID CONTAINERS OR OBJECTS ON THE TRAY SURFACE (additional component 824) THAT COULD CAUSE DAMAGE OR BURNS...
For these reasons GRILLO POSTURAL SYSTEM is equipped with two different gas springs to allow the seat inclination and backrest recline to be changed easily and safely 3.6 OPERATING ENVIRONMENTAL CONDITIONS...
4. DEVICE DESCRIPTION 4.1 INTENDED USE OF THE MEDICAL DEVICE GRILLO POSTURAL SYSTEM is a postural sitting unit intended for children with disabilities (Infantile Cerebral Palsy, degenerative pathologies with functional impairments, syndromic pathologies with impairments functional) easily adaptable thanks to its modularity.
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- Heel rests and footplate OUTDOOR BASE, reversible facing-parents - Compact and lightweight frame with the new innovative Ormesa Design, easily maneuverable and foldable, with tilting front handle. It adapts to the height of the mother and reduces the encumbrance in depth.
5. OPERATING INSTRUCTIONS 5.1 OPENING THE STROLLER a) WITHOUT THE SEAT RECOMMENDED PROCEDURE CLOSING LOCK CLOSING LOCK CLIK A CLICK MEANS THAT THE FRAME IS LOCKED LOCK THE HANDLEBAR MAKE SURE THE FRAME IS LOCKED Pag. 16/72...
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b) WITH THE SEAT ATTACHED A CLICK MEANS THAT THE FRAME IS LOCKED LOCK THE HANDLEBAR MAKE SURE THE FRAME IS LOCKED CLOSING LOCK Pag. 17/72...
ADJUSTMENT AND CONFIGURATION OF THE MEDICAL DEVICE by the health professional HOW TO ATTACH THE SEAT TO THE FRAME CLIK 3D VIEW MAKE SURE THE FRAME IS LOCKED LATERAL VIEW Pag. 18/72...
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ATTENTION! BEFORE POSITIONING THE CHILD, MAKE SURE THAT THE SEAT UNIT IS ATTACHED TO THE FRAME IF THE SEAT REMAINS ATTACHED verify on both sides GREEN IS ATTACHED verify on both sides IF THE SEAT TILTS, IT IS NOT ATTACHED RED IT IS NOT ATTACHED GREEN AND RED...
BRAKING UNLOCKING LEVER BRAKE PEDAL LOCK UNLOCK BEWARE! BEFORE PLACING OR REMOVING THE CHILD FROM GRILLO POSTURAL SYSTEM AS AND BEFORE ANY ADJUSTMENT, IT IS NECESSARY TO BRAKE THE AID. Pag. 21/72...
HOW TO DETACH THE SEAT FROM THE FRAME 1- PUSH THE SAFETY BUTTON DOWN WITH YOUR THUMB 2- PULL THE LOCKING LEVER 3- SLIDE UP THE SEAT SAFETY PUSH-BUTTON LOCKING LEVER Pag. 22/72...
FOLDING THE BASE PULL THE LOCKS WITH BOTH HANDS GENTLY PULL THE HANDLE DOWNWARD UNLOCK THE HANDLEBAR AND ROTATE IT BLOCKING WE SUGGEST TO CLOSE THE BASE WITHOUT THE SEAT Pag. 23/72...
ADJUSTING THE INCLINATION OF THE HANDLE IT CAN BE ADAPTED TO DIFFERENT ASSISTANT'S HEIGHTS AND FACILITATES THE ENTRANCE INTO THE ELEVATOR AND ITS TRANSPORT INTO THE CAR UNLOCK LOCK FRONT WHEEL DIRECTION LOCKS UNLOCK LOCK DIRECTION LOCK Pag. 24/72...
BACKREST HEIGHT ADJUSTMENT 1) LOOSEN THE SIDE SCREWS INDICATED 2) ADJUST THE HEIGHT OF THE BACKREST TO THE DESIRED POSITION TIGHTEN THE SCREWS BACKREST HEIGHT ADJUSTMENT SCREW WRENCH SUPPLIED Pag. 25/72...
ADJUSTING THE INCLINATION OF THE SEAT (TILT-IN-SPACE SYSTEM) BACK VIEW GREEN KNOB FOR ADJUSTING THE INCLINATION OF THE SEAT (TILT-IN-SPACE SYSTEM) Pag. 27/72...
SEAT DEPTH ADJUSTMENT 1) LOOSEN THE LATERAL SCREWS 2) ADJUST THE DEPTH OF THE SEAT TO THE DESIRED POSITION 3) TIGHTEN THE SCREWS SEAT DEPTH ADJUSTMENT SCREWS Pag. 28/72...
SEAT SIDE ADJUSTMENT DEPTH ADJUSTMENT First remove the upholstery of the side joint LOOSEN THE LATERAL SCREWS ADJUST THE SIDE IN DEPTH TIGHTEN THE SCR EWS Pag. 29/72...
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WIDTH ADJUSTMENT AND HORIZONTAL TILT First remove the upholstery of the side joint LOOSEN THE INDICATED SCREWS ADJUST THE SIDE IN WIDTH AND HORIZONTAL TILT TIGHTEN THE SCREWS VIEW FROM ABOVE Pag. 30/72...
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HEIGHT ADJUSTMENT, ANTERO-POSTERIOR AND VERTICAL TILT ADJUSTMENTS First remove the upholstery of the side joint LOOSEN THE INDICATED SCREWS ADJUST THE SIDE TO THE DESIRED POSITION TIGHTEN THE SCREWS Pag. 31/72...
LEGREST ADJUSTMENT TILT ADJUSTMENT 1) TURN THE LEVER COUNTERCLOCKWISE TO RELEASE THE LEGREST 2) ADJUST THE LEGREST IN TILT 3) TURN THE LEVER CLOCKWISE TO LOCK IT LEGREST TILT ADJUSTMENT UNLOCK LEVER LOCK Pag. 32/72...
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HEIGHT ADJUSTMENT 1) LOOSEN THE LATERAL SCREWS 2) ADJUST THE HEIGHT OF THE FOOTREST 3) TIGHTEN THE SCREWS LEGREST HEIGHT ADJUSTMENT LEVER Pag. 33/72...
5.4 ADJUSTMENT AND CONFIGURATION OF THE ADDITIONAL COMPONENTS by the health professional POSTURAL HEADREST 863 1. POSITION THE HEADREST ATTACHMENT ON THE BACK OF THE BACKREST MOUNTING 2. REMOVE THE UPPER KNOB 3. SCREW THE TWO SCREWS 4. TIGHTEN THE KNOB KNOB Pag.
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ADJUSTMENT LOOSEN THE THREE KNOBS ADJUST THE INCLINATION, THE HEIGHT AND DEPTH OF THE HEADREST TIGHTEN THE KNOBS KNOBS WIDTH ADJUSTMENT SCREWS Pag. 36/72...
ERGONOMIC HEADREST 942 MOUNTING 1. POSITION THE HEADREST ATTACHMENT ON THE BACK OF THE BACKREST 2. REMOVE THE UPPER KNOB 3. SCREW THE TWO SCREWS 4. TIGHTEN THE KNOB KNOB Pag. 37/72...
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ADJUSTMENT LOOSEN THE THREE KNOBS ADJUST THE INCLINATION, THE HEIGHT AND DEPTH OF THE HEADREST TIGHTEN THE KNOBS KNOBS Pag. 38/72...
HEADREST with PARIETAL PROTECTIONS 852 1. POSITION THE HEADREST ATTACHMENT ON MOUNTING THE BACK OF THE BACKREST 2. SCREW THE TWO SCREWS ADJUSTMENT WIDTH ADJUSTMENT SCREWS Pag. 40/72...
TRUNK SIDE SUPPORTS 838 First remove the upholstery of the side joint MOUNTING INSERT THE SIDE SUPPORTS AND TIGHTEN THE SCREW (by inserting the wrench in the indicated hole) HEIGHT ADJUSTMENT First remove the upholstery of the side joint 1) LOOSEN THE SCREW (by inserting the wrench in the indicated hole) 2) ADJUST THE SIDE SUPPORTS IN HEIGHT 3) TIGHTEN THE SCREW...
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WIDTH AND ROTATION ADJUSTMENT First remove the upholstery of the side joint LOOSEN THE INDICATED SCREWS ADJUST THE SIDE SUPPORT IN WIDTH AND TIGHTEN THE SCREWS Pag. 42/72...
WRAPPABLE AND FLEXIBLE TRUNK SUPPORTS 868 multiadjustable in height, width and inclination MOUNTING AND HEIGHT ADJUSTMENT INSERT THE SIDE SUPPORT TO THE DESIRED HEIGHT AND TIGHTEN THE SCREW (by inserting the wrench in the indicated hole) Supplied wrench Supplied wrench Pag.
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WITH AND ROTATION ADJUSTMENT First remove the upholstery of the side joint 1) LOOSEN THE INDICATED SCREWS 2) ADJUST THE SIDE SUPPO ROTATION 3) TIGHTEN THE SCREWS Supplied wrench BACKREST BACKREST FRONT VIEW FRONT VIEW Pag. 44/72...
ELBOW SIDE SUPPORTS 961 MOUNTING AND HEIGHT ADJUSTMENT INSERT THE PAD TO THE DESIRED HEIGHT AND TIGHTEN THE SCREW (by inserting the wrench in the indicated hole) BACK VIEW Supplied wrench Supplied FRONT VIEW wrench Pag. 45/72...
ADJUSTABLE ABDUCTION BLOCK 834R ATTENTION! TIGHTEN THE KNOB WELL KNOB ZIPPER Pag. 53/72...
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ADJUST THE LEFT PART OF THE ABDUCTION BLOCK SHEET IN WIDTH Supplied wrench ADJUST THE RIGHT PART OF THE ABDUCTION BLOCK SHEET IN WIDTH BACK VIEW Pag. 54/72...
HAND BRAKE 905 1. ASSEMBLE THE BRAKE LEVER 2. FIX THE BRAKE CABLES 3. REMOVE THE CABLES OF THE PEDAL BRAKE 4. FIX THE LOWER CABLES OF THE MANUAL BRAKE strap BEWARE! WHILE THE MANUAL BRAKE IS IN USE THE PEDAL BRAKE IS OUT OF ACTION Doubler Pag.
RAIN COVER THE RAIN COVER CAN ONLY BE ATTACHED ON THE CANOPY (819) 1- ATTACH THE RAIN COVER POUCH WITH THE TWO BUTTONS LOCATED ON THE BACK OF THE CANOPY 2- OPEN THE ZIPPER ON THE POUCH 3- REMOVE THE RAIN COVER FROM THE POUCH AND POSITION IT SO THAT IT COVERS THE STROLLER 4- ATTACH THE RAIN COVER TO THE FRAME USING THE STRAPS WITH BUTTONS Pag.
TRANSPARENT TRAY Adjustable in height, depth and tilt Knob FRONTAL VIEW Knob on both sides locking lever on both sides locking lever on both sides TIGHTEN THE KNOB Pag. 61/72...
OXYGEN BOTTLE HOLDER BEWARE! during transport on a moving vehicle, the oxygen bottle and the respirator have to be removed from the pushchair frame to avoid damages in case of an accident, and they have to be secured to the vehicle to reduce the chances of injury to the other occupants supplied screws supplied nuts...
6. CLEANING AND DISINFECTION Cleaning operations (and those of disinfection before reuse of the device with a new user) should be carried out regularly with the procedures and timelines outlined in § 6.3 by the family or care giver. 6.1 INFORMATION SANIFICATION is the complex of cleaning and / or disinfection procedures and operations The CLEANING is a physical and mechanical process (i.e., rubbing) with which a large part of potential pathogenic microorganisms (bacteria, fungus, or virus), further to the visible dirt, is...
The operations of sanitization must be performed without the user inside the device. Do not use compressed air, which can cause aerosol and contamination of possible virus and bacteria in the environment and on his own person During the Covid-19 epidemic, the contaminated PPE (gloves, gowns, glasses, masks, caps, etc…) must be thrown away in the general waste bin, unless otherwise indications by the belonging municipality 6.3 PROCEDURE...
If in doubt about the safety or damage of the product, cease use and contact the orthopedic workshop that supplied the product, or ORMESA. 7.1 ORDINARY MAINTENANCE OPERATIONS (monthly) Routine periodic checks and maintenance should be carried out by a person with good technical competence;...
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Check the tightness of the adjustment mechanisms. If unsuccessful, contact the health professional who provided it, or distributor for replacement with an original component. In case you have encountered an inefficiency in TIGHTENING of the ADJUSTMENT LOCKING LEVERS of the ARMREST, LEGREST, HEADREST, TABLE, discontinue use and contact the health professional who provided it, to register the levers as described in the following §...
REGISTRATION OF ADJUSTMENT LOCKING LEVER Adjust nuts and screws in small increments until proper tightness is restored Armrest and leg rest adjustment locking levers WRENCH Pag.
Extraordinary maintenance must be carried out by the health professional who supplied the product or by another subject indicated by the Manufacturer or the Distributor of the ORMESA products in the country of destination. The interventions must be performed with ORIGINAL REPLACEMENTS PARTS of the...
Quality Management System certificated in 1998 according to ISO 13485, there is adequate confidence that the average lifespan of GRILLO POSTURAL SYSTEM is about 5 years, on condition that it is used according to the directions given in the user manual.
9. END-OF-LIFE MANAGEMENT OF THE MEDICAL DEVICE 9.1 USER OBLIGATIONS Comply with applicable local regulations and do not dispose of old products in normal household waste but separately in appropriate collection places. Proper disposal of the product helps to avoid possible negative environmental and human health consequences.
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Ormesa srl Via delle Industrie, 6/8 - Z.I. Sant’Eraclio - 06034 FOLIGNO (PG) ITALY P.I. IT 00574020541 CCIAA Perugia 119215 Iscr. Trib. Perugia 11907 Tel. + 39 0742 22927 Fax +39 0742 22637 info@ormesa.com www.ormesa.com SINCE 1980 Health Professional As Manufacturer, ORMESA srl reserves the right to make any modifications it...
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