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08-05-17425

USE AND MAINTENANCE HANDBOOK

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Thank you for choosing 425 WORKING TABLE, from ORMESA s.r.l. The 425 WORKING TABLE combines style and ergonomics without compromising on safety. ORMESA recommends that you read this manual very carefully to fully understand its contents. In addition to helping you become familiar with 425 WORKING TABLE quickly, it also contains practical tips for making the best use of it safely and keeping it in good working order. Following the recommendations of this manual will help you achieve the rehabilitative goal for which this aid was developed. If, after reading it, you still have questions, contact your retailer, who will be happy to help you, or call INNOVATION IN MOTION directly at 1.260.665.2769, send a fax to 1.260.665.3047 or send an e-mail to iim@mobility-usa.com. Luigi Menichini Managing Director

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TABLE OF CONTENTS

WARNINGS........................................................................................................................ 3

CE CONFORMITY DECLARATION ................................................................................. 5

GUARANTEE ..................................................................................................................... 6

HOW TO STORE AND TRANSPORT THE MEDICAL DEVICE .................................... 6

LABELS AND PLATES .................................................................................................... 7

SOME EXAMPLES OF WHAT NOT TO DO WITH 425 ................................................. 7

TECHNICAL SPECIFICATIONS ...................................................................................... 8

INITIAL PREPARATION ................................................................................................... 9

HOW IT IS COMPOSED ................................................................................................... 10

WHAT 425 IS AND HOW TO USE IT .............................................................................. 10

HEIGHT ADJUSTMENT of the top of the table ........................................................ 11 TILT ADJUSTMENT of the top of the table ............................................................... 13 Fixing/taking the BOOK SUPPORT and the PEN SUPPORT out ............................. 14

MAINTENANCE, CLEANING AND DISINFECTION ...................................................... 15

CUSTOMER SERVICE AND SPARE PARTS ................................................................. 16

CONDITIONS FOR DURABILITY, REUSE AND REASSIGNMENT TO A NEW USER

............................................................................................................................................ 17

Pag. 3/17

WARNINGS

- CAREFULLY READ AND UNDERSTAND THE INSTRUCTIONS IN THIS MANUAL BEFORE USING THE DEVICE because they have been written with the user's safety in mind and they will help the carer use the product safely and keep it in good working order. The Use and Maintenance Manual is an integral part of the product and must be carefully preserved for future reference.

- THE MANUAL IS INTENDED FOR TECHNICALLY QUALIFIED RETAILERS AND USERS AND THEIR ASSISTANTS; it provides instructions for its correct use and must be supplemented by adequate knowledge of the rehabilitation program for which it has been prescribed.

- 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 without any obligation to update its previous production and relevant manual.

- THE DEVICE MUST BE PRESCRIBED BY A MEDICAL SPECIALIST who will also supervise its use.

- ATTENTION! MAKE SURE THAT ALL ADJUSTABLE PARTS HAVE BEEN LOCKED before each use, to avoid dangerous situations for the user

- ATTENTION! ADJUST THE DEVICE TO THE CORRECT POSITION FOR ITS USER (pages 11, 12, 13)

- The product MUST ONLY BE USED BY PERSONS WHOSE BODILY MEASUREMENTS AND WEIGHT CONFORM TO THE SPECIFICATIONS IN THE PARAGRAPH “TECHNICAL SPECIFICATIONS” on page 8 of this manual.

- THE 425 WORKING TABLE IS FOR INTERNAL USE

- CLEAN THE DEVICE FOLLOWING THE INSTRUCTIONS shown in the “MAINTENANCE” section (see page 15)

- ATTENTION! THE PRODUCT IS NOT FIREPROOF, so keep 425 far from flames, cigarettes or fires

Pag. 4/17

425 IS A MECHANICAL MEDICAL DEVICE:

Perform REGULAR MAINTENANCE and CLEANING following the instructions shown in the "Maintenance" chapter on page 15-16 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 15-16 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 and 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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CONFORMITY DECLARATION

ORMESA S.r.l. guarantees and declares, under its own exclusive responsibility, that the following medical device, technical aid for rehabilitation:

425 school & free time tablewhich this declaration refers to, conforms with the general requirements provided in the medical devices Directive 93/42/EEC and subsequent amendments and additions, according to which this device is class 1 and has been designed in observance of the following standards:

CEI EN ISO 14971:2012 Medical Devices - Application of risk management to medical devices

EN 12182:2012 Technical aids for disabled persons - general requirements and testmethods

EN 1041:2013 Information supplied by the manufacture with medical devices

ISO 9999:2016 Technical aids for persons with disabilities - classification and terminology

Foligno, 20/02/2017 The Legal Representative

Luigi Menichini

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GUARANTEE

ORMESA and INNOVATION IN MOTION warrant the product for 2 years; in case of problems, contact the retailer where you purchased it. Always ask for original spare parts, otherwise the guarantee will decline

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.

HO HOW TO STORE AND TRANSPORT THE MEDICAL DEVICE

TO AND TRANSPORT THE MEDICAL DEVICE

THE DEVICE MUST BE STORED AND PACKED using the Ormesa original packaging materials, unless the guarantee will be voided

- Once unpacked, THE TRANSPORT OF THE DEVICE must be done byANCHORING ADEQUATELY it to the vehicle

- When travelling by plane, or in the car, DO NOT SUBJECT THE FOLDEDFRAME TO LOADS THAT, especially with road bumps, COULD DAMAGE ITSSTRUCTURE

THE DEVICE MUST BE PARKED / STORED IN CLOSED AND DRY PLACES

- THE OPERATING ENVIRONMENT HAS NO PARTICULAR INFLUENCE ON THEDEVICE 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 sliding parts. IN THIS CASE, WE RECOMMEND CAREFULLY CLEANING AND DRYING THE FRAME FOLLOWING THE INSTRUCTIONS SHOWN IN THE “MAINTENANCE, CLEANING AND DISINFECTION” CHAPTER ON PAGES 15-16 AND THE WARNINGS ON PAGE 16

AND 14 OF THIS MAN

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LABELS AND PLATES

SOME EXAMPLES OF WHAT NOT TO DO WITH 425

- never use the aid if the user has not the same size and weight as the ones specified; the aid has to be prescribed by doctors or therapists according to the legislation, rules and laws in force

Do not use the device on uneven ground, near strong slopes or stairs

- do not place hot containers or objects on the tray surface because they could tip over and because the wood or covering could be severely damaged

- do not let anyone else use the aid, not even to play it.

- never leave the user alone in the device

- never used the product on a sloping surface

- don't let anybody get on the top of the table, nor seated neither standing

- do not use the product if parts are missing or damaged. insist that only original replacement parts are used because any other type will void the warranty and

marking

Series number Article number

Max load

Date ofproduction

Warning! Read theuseand maintenancehandbook before use

Conformity with theEuropean safety

standards

LOT code

®s.r.l.

Via A. Da Sangallo, 1 06034 Foligno (PG) ITALY Tel. +39 074222927 Fax +39 074222637

M O D E L . P A R T N °

S NLOT MAX. KG

!

Name of the model

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TECHNICAL SPECIFICATIONS

- Varnished and chromium-plated frame;- washable top of the table. it has edge and hollow and it is adjustable in height and tilt;- the book and pen supports are given in order to use also the top of the table while it is

inclined;- side hook for bag.

Dimensions in cm

425-2 WORKING TABLE WEIGHT OF THE AID kg. 9

425-3 WORKING TABLE WEIGHT OF THE AID kg. 12

425-4 WORKING TABLE WEIGHT OF THE AID kg. 13

42 -

6055

- 84

72 -

107

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INITIAL PREPARATION

INFORMATION ABOUT THE PACKING

REMOVING 425 WORKING TABLE FROM THE BOX

ATTENTION!CUT WITHOUT PRESSING TOO HARD

WITH THE BLADE SO AS NOT TO DAMAGE THE CONTENTS OF THE BOX

With 425-3 e 425-4 With 425-2

425working

table

Acm

Bcm

Ccm

VOLUMEm3

WEIGHTKg

425-2 70 66 50 0.231 14

425-3 70 60 88 0.369 16

425-4 75 65 88 0.396 17

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HOW IT IS COMPOSED

Table

Side hook for bag

Frame

Book support

Pen support

WHAT 425 IS AND HOW TO USE ITThe aim of the WORKING TABLE 425 is to let the user get a correct position on the top of the table in order to handle objects or read a book. The position of the User must be always considered: vertical or seated.

It is adjustable in height and tilt. the top of the table has a hollow to let the User well reach it and to help the leaning of the arms.

Thanks to the edge the objects on the top of the table cannot fall and the two bars on it are book and pen supports which may be useful while working with the inclined table. On the right of the frame there is a side hook that can be used as a bag holder.

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HEIGHT ADJUSTMENT of the top of the table

WARNING!:

- Before adjusting the table, remove any material that if tips over could damage or cause harm to people

- Make any adjustments without the user

1. Loose the shown knob supporting the frame of the table with the other hand

2. loose the other knob supporting the frame of the table with the other hand

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3. Adjust the table to the desired height by using both hands.

4. tighten the shown knob supporting the frame of the table with the other hand.

5. tighten the other knob supporting the frame of the table with the other hand.

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height adjustmentindicator

the sign "STOP"indicates themaximum height

TILT ADJUSTMENT of the top of the table

the possible noise during the height adjustment, is not a defect of the table but it is due to the presen-ce of springs inside the tubes, useful to cushion the descent of the tabletop

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Fixing/taking the BOOK SUPPORT and the PEN SUPPORT out

With 425-2

Fixing/taking the BOOK SUPPORT and the PEN SUPPORT out

With 425-3 e 425-4

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MAINTENANCE, CLEANING AND DISINFECTION

REGULAR (OR PREVENTIVE) MAINTENANCEREGULAR MAINTENANCE MUST BE PERFORMED ONCE A MONTH. REGULARMAINTENANCE IS REQUIRED TO KEEP THE PRODUCT WORKING PROPERLY AND SAFELY AND IS ESSENTIAL FOR KEEPING THE CE MARK.

THE MANUFACTURER IS NOT LIABLE FOR THE PERFORMANCE OF THE PRODUCT UNLESS REGULAR MAINTENANCE IS PERFORMED (ATTACHMENT 1, DIRECTIVE 2007/47/CE). THE MANUFACTURER ALSO RECOMMENDS THAT YOU HAVE THE SUPPLIER PERFORM A COMPLETE REVIEW OF THE PRODUCT'S OPERATION AND SAFETY WITH THE FOLLOWING FREQUENCIES:

1) at three months from purchase; 2) at six months from purchase; 3) once a year for subsequent years after that of purchase.

Clean and disinfect the device and its accessories regularly, following the instructions provided below.

CLEANING AND DISINFECTING THE PAINTED AND CHROME-PLATED FRAMEClean and disinfect the painted and chromed parts with a soft cloth dipped in alcohol diluted with water. DO NOT GREASE THE ADJUSTABLE PARTS.

CLEANING THE TOP OF THE TABLEClean the top of the table with a soft cloth and detergent. After cleaning, dry them up with a soft cloth.

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EXTRAORDINARY (OR CORRECTIVE) MAINTENANCE EXTRAORDINARY MAINTENANCE MEANS ANYTHING DONE TO THE PRODUCT THAT IS NOT MENTIONED ABOVE. WE RECOMMEND THAT THE USER, RETAILER AND HEALTH FACILITIES ENTRUST ALL EXTRAORDINARY OR CORRECTIVE MAINTENANCE TO THE MANUFACTURER OR OTHER FACTORY-AUTHORIZED SERVICE CENTRE.

ANY OTHER SOLUTION WILL RESULT IN THE USER AND THE THIRD-PARTY MAINTAINER FULLY RESPONSIBLE FOR THE RESULTS OF THEIR WORK AND THE MANUFACTURER WILL ONLY BE LIABLE FOR ORIGINAL DEFECTS OF MATERIALS OR WORKMANSHIP.

If the product is to be disposed of, it must be done according to the law in the country of destination

CUSTOMER SERVICE AND SPARE PARTS Only contact the retailer where you purchased the product for service and replacement parts.

Do NOT perform maintenance or replace parts or accessories when the user is sitting on the device

Intensifie all checks in marine environments, clean more often, anoint the parts exposed to salt corrosion (such as chrome, bolts and screws)

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CONDITIONS FOR DURABILITY, REUSE AND REASSIGNMENT TO A NEW USER

Granted that Ormesa products should be selected, evaluated and ordered for the needs of an individual user, reuse is however possible with the respect the following conditions.

Based on the experience of other similar sold models, on technological progress, on the guarantees of the Quality Management System certificated in 1998 according to ISO 9001, there is adequate confidence that the average lifespan of the table 425 is about 5 years, on condition that it is used according to the directions given in the user manual.

Only when the conditions for storage and transport of chapter HOW TO STORE AND TRANSPORT THE MEDICAL DEVICE” are followed, the periods in which the product is stored at the dealer should not be considered in that time period

Factors unrelated to the product such as the development of the user, its diseases, the use and the surrounding environment can make significantly lower the duration of life of the product; on the contrary, if the indications on the use and maintenance are properly observed, the reliability of the product can extend well beyond the lifetime average above.

Prior to recycling or reassignment an already used Ormesa product, it is required that:

1. a doctor or therapist verifies that the aid is appropriate and adequate to meet the dimensional, functional and postural needs of the new user, and if all its components are suitable / appropriate for him. You should also consider that the -marking and the manufacturer's responsibility for safety requirements for the product remain only if the original product still has not changed and only original accessories or spare parts have been applied

2. qualified technical personnel of a company specialized in the maintenance of technical aids for disabled people performs a detailed technical inspection to verify its condition and wear, the absence of any damage and failure of all components / adjustments, the presence of the user’s manual, of the label with the date and serial number. A copy of the manual and maintenance may be always requested to the retailer that supplied the product or directly to Ormesa

3. The product has been thoroughly cleaned and disinfected following the directions given in the “MAINTENANCE, CLEANING AND DISINFECTION” Chapter

We recommend you keep written records on all inspections performed on the product before any assignment to the new user.

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 disabile, or directly ORMESA

Authorized Dealer

The technical Data and information given in this handbook are not binding. ORMESA reserves the right to carry out any necessary change without prior notice or replacements

DISTRIBUTOR FOR USA: INNOVATION IN MOTION201 Growth Parkway ANGOLA, IN 46703

P 1.260.665.2769F 1.260.665.3047

Toll free number 800-327-0681E-mail: iim@mobility-usa.com

SINCE

1980

COMPANY WITH QUALITY MANAGEMENT SYSTEM

CERTIFIED BY