- 1. Labelling
- 2. Using the device
- 3. Warnings to reduce any risks associated with misuse of the device
- 4. Product presentation
- 5. Preparation for use
- 6. Accessories
- 7. Maintenance, inspections and controls
- 8. Cleaning instruction
- 9. Technical service
- 10. Warranty terms
- 11. Packaging, shipment and delivery
- 12. Correct disposal and recycling
- 13. Adjustments
Thanks for choosing an OFFCARR product.
OFFCARR listens and responds to the customers' needs by engineering highly technical, innovative solutions aimed at reducing daily mobility problems, with special attention to product style and to improving quality of life.
OFFCARR has a certified system for quality management following UNI EN ISO 9001 regulations and a Medical Device - Quality management system following UNI EN ISO 13485 regulations.
OFFCARR products comply with the european medical device regulation UE MDR 2017/745.
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Before using or making adjustments on this device, read this instruction manual carefully. |
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Different versions of this manual, accessible for various types of visual disabilities are available on www.offcarr.com |
Contact an authorized dealer or the manufacturer at the following address if clarification regarding the safety measures is required.
OFFCARR srl |
MADE IN ITALY |
Distributor: |
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1. Labelling
Each OFFCARR product is identified by a unique serial number. The serial number, along with other information is visible on the product stickers applied to the frame.
Stickers position on the product frame |
Product sticker (applied on the frame) |
UDI sticker (applied on the frame and on the instructions for use) |
Information available on the product sticker: |
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1.1. Symbols description
Please read all instructions before using the device. Read all Cautions and Warnings carefully. |
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European Conformity - The symbol denotes conformity to European standards. |
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WARNING: Read carefully and follow the indications. |
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NOTE: Auxiliary information. |
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Medical Device |
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UDI: Unique Device Identifier |
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Serial Number |
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Reference - The symbol indicates the model of the product. |
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The symbol indicates the country of origin. |
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The symbol indicates the distributor of the product. |
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The symbol indicates the manufacturer of the product. |
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The symbol indicates the maximum load permissible for the product. |
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The symbol denotes the importance of protecting the packaging and the product from harsh weather. |
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The symbol denotes that shipment must be performed with care and the package must always be kept and stored with the arrows pointing upwards. |
2. Using the device
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In order to move safely and properly use the device, it is always recommended to consult qualified personnel. |
Hereafter are some suggestions for a correct use of the device, also aimed to maintain the characteristics of safety and durability over time:
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The brakes only have a parking purpose and should never be used as service brakes to slow down the device in motion.
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Do not lean too far forward, because by moving the centre of gravity, the device could tip-over.
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The device should be used only in accordance with what is proposed in this manual and not of objects in general.
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Always deal with slopes above 6° with assistance from an attendant.
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Prolonged contact of the device with water or prolonged exposure to high humidity levels can cause unwanted oxidation of some metal parts and decay of the security features of the materials involved.
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Avoid contact with seawater and sand. In case of contact proceed to an immediate and accurate cleaning.
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Clean periodically the device using a damp cloth and avoid even partial immersion of the frame. Keeping the device clean enhances its efficiency.
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Suspend the use of the product and notify OFFCARR in case of allergic reactions or if other similar problems are developed after contact with the device materials. |
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There is no apparent danger of causing injury to people during the operations of preparation and setup of the device if carried out according to the instructions provided in this manual. |
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Make sure the tyres are correctly inflated. Since the correct pressure differs between models, read the required pressure on the side of the tyre itself. |
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Keep the device away from heat sources, as not all the components are fireproof. |
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Upholstery materials comply with the EN 1021-2:2014 regulation. |
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The approximate lifespan of the device is 7 years, considering correct, normal daily use by a single user and regular maintenance. |
3. Warnings to reduce any risks associated with misuse of the device
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It is forbidden to use the device or its parts in different ways from those described on this manual. |
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Do not use the brakes, if available, to slow down the device at any speed. They are only designed as parking devices. |
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With pneumatic tyres, it is recommended to reduce their pressure in the case of air transport, to avoid collateral effects of pressure variations due to altitude. |
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To maintain the device efficient and maintain its safety requirements it is recommended to uphold a regular upkeep schedule, as described by this manual. |
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Poor maintenance and improper use of the device can cause damage or injury to the user or assistant. |
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Any tampering with the components of the device, as well as voiding the warranty, could compromise its structural integrity and safety standards. |
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Contact OFFCARR in case the maximum user weight is exceeded at any point during the device’s lifespan. |
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Contact OFFCARR or your reseller to check for compatibility with accessories produced by a manufacturer different from OFFCARR. |
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Do not install on the device mechanical or electronic devices that are not approved by OFFCARR and do not modify its structure in any way. Any combination with other medical devices must be authorized by OFFCARR. In case the combination has been approved, always refer to the respective manuals. |
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The device and its accessories are not suitable for use in hyperbaric chambers under any circumstances. |
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In case of prolonged exposure to the sun, the surface of the device can reach high temperatures. |
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The device is not designed and certified for use as forward-facing seat on a motor vehicle. |
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Before transferring to or from the device, activate the parking brakes. Always perform transfers with caution. |
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Some openings in the device may have angles lower than 75° (e.g. space between wheel spokes) or gaps smaller than 25 mm (e.g. gaps between spokes). |
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Use the device and its parts exclusively for their intended purpose. |
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The device is suitable for use by children and teenagers; however, adult supervision is recommended. |
4. Product presentation
4.1. HAPPY STANDING
HAPPY STANDING is a device designed so that children with lower limb impairment can maintain an upright position with the ability to move independently.
The device is suitable for indoor use, limited by the size of the spaces and the size of the device.
HAPPY STANDING are non-invasive medical devices specifically designed to reduce and counterbalance motor impairments in the medium and long-term.
Only qualified operators must setup the device.
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It is forbidden to use the device or its parts in different ways from those described in this manual. |
4.1.1. Description
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4.1.2. Features
HAPPY STANDING: Standing aid available in smaller measurements, suitable for children.
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Max user height: 130 cm
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Fixed steel and aluminium frame
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Three pushing wheel dimensions: 24", 26" or 28"
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With pushrim and parking brakes activated also by user
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Pivoting rear caster with integrated brake activated by attendant
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Front safety wheels
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Customizable with abductor, saddle, pelvic support, table or any combination of them
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Maximum load: 75 kg
4.1.3. Measurements table
All measurements are in degrees (°) and millimetres (mm), the weight is expressed in kilograms (kg).
HAPPY STANDING |
Reference values |
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Chest support |
adjustable in height |
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Saddle |
adjustable in height |
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Pelvic support |
adjustable in depth and height |
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Calf supports |
adjustable in height, depth, width position |
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Total width |
600 |
7001 |
Total length |
1000 |
12001 |
Total height |
adjustable |
12001 |
Weight2 |
24.5 kg |
All measurements refer to device in standard configuration
The addition of accessories may modify the indicated measurements and weight
1 Some measurements may exceed the reference values according to UNI EN 12183. In some circumstances and with certain configurations, the use of safety exits may be complicated or impossible
2 The weight depends on the selected configuration and may vary based on accessories.
4.1.4. Push wheel and pushrim diameter
The table indicates diameter of front wheels and relative pushrims.
| Front wheel diameter | Pushrim outer diameter (average) |
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24" |
535 mm |
26" |
590 mm |
28" |
620 mm |
5. Preparation for use
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The preparation for use of these devices must be performed by qualified personnel to ensure the specific suitability of the product for the user and the correct working order of all parts and accessories, as well as to provide clear instructions to the user. |
5.1. Quick-Release Check (HAPPY STANDING)
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Before using the device, make sure to verify the proper functioning of the quick-release devices. |
Normally, the device is shipped with the wheels already mounted.
However, it is necessary to check the correct operation of the quick-release mechanism and the proper attachment of the wheels to the frame before using the device.
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For safety reasons, it is important to repeat this check every time the rear wheels are assembled. |
5.2. Tyre pressure check
A periodical check of the tyre pressure helps to keep the device efficient and more comfortable
Verify the tyre pressure value according to the value marked on the tyre. Indicatively the maximum pressure for the most common wheels is:
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7.5 bar (750 kPa - 110 psi) for high pressure wheels
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With pneumatic tyres, it is recommended to reduce their pressure in the case of air transport, to avoid collateral effects of pressure variations due to altitude. |
Unresolved directive in happy_standing.adoc - include::../lingue/en/modelli/happy_standing/brakes.adoc[]
5.3. Accessories check
Some accessories required when setting up the device may be supplied separately. You must assemble them and check their operation before you start using the device.
6. Accessories
HAPPY STANDING can be configured with different accessories, described in the following paragraphs.
6.1. Spokes guards
Spokes guards on the rear wheels serve as an esthetic feature as well as protection against accidental insertion of the user’s fingers or hands between the spokes of the wheels. They can be attached to the spokes with velcro or clips depending on the specific model.
7. Maintenance, inspections and controls
Weekly:
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✓ Check the tyre pressure. Each tyre shows on the lateral bands the maximum pressure for which they are designed. A flat tyre affects the efficiency of brakes and the agility of the wheelchair.
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✓ Check the efficiency of the quick-release axle (see 5.1, “Quick-Release Check (HAPPY STANDING)”) and if necessary proceed with the lubrication of axle and bushes.
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✓ Check the tension of the backrest upholstery to maintain a comfortable position.
Quarterly:
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✓ Check the tightness of all the devices' screws.
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✓ Check the perpendicularity of the front fork support screws.
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✓ Check the wear of the front wheels. Solid wheels might be worn to the point of affecting the overall wheelchair front setup. In this case adjust the front fork assembly or replace the wheels (see [replace_front_wheel]).
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✓ Check the efficiency of the bearings. Replace any stuck bearings if necessary (see [replace_bearings_rear], [replace_bearings_front] and [replace_bearings_fork]).
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✓ Check the efficiency of the brakes and, in case, adjust them. If the knurled pin has to be replaced, consult authorised personnel.
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✓ Lubricate moving parts such as hinges, bearings and quick-release axles. It is suggested to use silicon oil, which is efficient and doesn’t smear.
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Only choose original parts when purchasing accessories or spare parts. Contact OFFCARR if you can’t find original spare parts on the market elsewhere. |
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It is recommended to refer only to authorized and qualified personnel to perform maintenance programs, adjustments, and to replace components or accessories. |
7.1. Replacement of tyre and inner tube
7.1.1. Removing the tyre and inner tube
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7.1.2. Assembling the inner tube and tyre
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7.2. Replacing Pushing Wheel Bearings (HAPPY STANDING)
Disassembly
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Assembly
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7.3. Quick extraction devices (HAPPY STANDING)
7.3.1. Check
The quick extraction axles are shipped already checked and adjusted. However, it is recommended to periodically verify the effectiveness of their operation.
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7.3.2. Adjustment
If necessary, it is possible to adjust the axle to eliminate any play between the wheel and the frame or to complete the release of the button once the wheel is inserted. |
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If the quick-release button is not completely relaxed when the wheel is inserted in the frame, it is necessary to extend the useful length of the L axle by partially unscrewing the Y nut.
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If once the wheel has been inserted into the frame, there is play between the frame and the wheel itself, it is necessary to reduce the useful length of the L axis by partially tightening the Y nut.
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The Y nut thread has a pitch of 1 mm, therefore the unscrewing or screwing of one turn involves the elongation or reduction of 1 mm. In case of adjustment, it is advisable to proceed with successive adjustments of ¼ of a turn at a time. |
8. Cleaning instruction
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Cleaning and disinfection procedure have to be performed exclusively by qualified personnel. |
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Follow the instructions on this manual to perform the cleaning and disinfection procedure. |
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Use appropriate eye/facial protection and protective gloves, during cleaning and disinfection procedure. |
In case of contamination with blood or other body fluids, the device has to be cleaned first and then disinfected as follows:
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Most of the time is convenient and more effective to remove the upholstery from the frame before to proceed with the cleaning and disinfection of either frame or upholstery. |
FRAME
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Wash the device with lukewarm water and neutral detergent using a damp cloth to remove gross soiling
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Remove eventual detergent residuals only with lukewarm water
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Dry the device prior to further processing
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Visually inspect the cleanliness of the complete device
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Disinfect the device using 70-90% alcohol
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Be sure it is completely dry before proceeding with use
UPHOLSTERY
In case of the user remaining the same before and after the cleaning treatment:
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Wash, rinse, dry and disinfect the upholstery using the same process used for the frame
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Be sure the upholstery parts are completely dry before reassembling them
In case of different user after the cleaning treatment:
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The best course of action is to change the upholsteries with a new set
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During the cleaning process the device should be also carefully inspected for damage, oxidation and faults in function. If any damage or faults are found, the involved components should be removed for service, repair or replacement. |
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All waste materials related to this process must be disposed in compliance with specific local applicable law. |
9. Technical service
For any service request, please contact OFFCARR supplying the following indications:
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Model
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Serial number
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Fault description
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Any reference or order number, if available, recorded on the order form.
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Dealer
Every component of the device is available as spare part.
10. Warranty terms
It is strongly advised to register the product on the website www.offcarr.com after delivery.
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The device’s frame is guaranteed for 3 (three) years from the delivery date.
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The label showing the serial number, the manufacturer address and the CE symbol cannot be removed for any reason to preserve the warranty validity.
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Parts subject to normal wear and tear are not covered by the warranty, unless specific wear is caused by evident manufacturing fault.
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During the warranty period OFFCARR may proceed at its own discretion to change or to repair the faulty parts.
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The warranty does not cover damage due to negligence, carelessness, misuse or by incorrect maintenance performed by non authorized personnel.
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If any damage occurred during transport, the forwarder company is the only responsible. It is important to inform immediately both the forwarder company and, for information, OFFCARR.
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The warranty does not cover injury or any other damage to people or goods connected to the device’s malfunctioning.
11. Packaging, shipment and delivery
All OFFCARR products are shipped in closed cardboard cases to protect them from bumps and dust.
The package includes the device configured according with the order form, this Instruction manual and a tool kit.
The device must be transported in trucks that protect it from atmospheric agents, as shown on the packaging box.
Upon receipt, check the box integrity: open the package, remove the device and check it for damages. In case of problems, note your remark on the waybill and immediately notify both the forwarder and, for information, OFFCARR.
Once these checks, mandatory to ensure the validity of the warranty, have been carried out, place again the device in its packing until it is used and store in a cool and dry place (between - 15 and + 50 °C and with a relative humidity lower than 80 %).
Do not place any objects over the packaging box.
The packaging materials follow the European directive 94/62/EC[13].
12. Correct disposal and recycling
OFFCARR products are made of aluminium alloy (Al 7020, Al 6082, Al 2017, Al 6061, Al 5754), titanium, steel, stainless steel, carbon fibre, polyurethane, epoxy resins, other composite materials.
Recycle or disposal of all materials must be in compliance with the local applicable laws.
Contact your dealer in case of doubt or for help when disposing the device.
13. Adjustments
Considering potential setup restrictions it is still possible to perform other adjustment to hone in the wheelchair to the specific user.
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Please refer to authorized and qualified personnel to perform the adjustments described in this manual. |
13.1. HAPPY STANDING
Many of the components of HAPPY STANDING are adjustable to better suit the needs of the user.
13.1.1. Adjusting the angle of the support
To adjust the inclination of the support tube and achieve the desired position:
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13.1.2. Adjusting the chest support
The chest support is adjustable in both width and height:
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13.1.3. Adjusting the kneepads
The kneepads are adjustable in height, width, depth,retention and tilt:
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13.1.4. Footplate height adjustment
The footplate is height adjustable:
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It is recommended to keep the footplate as low as possible and to adjust the rest of the support in relation to that. This achieves the best reach to the pushrims for self-propelling. |
13.1.5. Abductor or saddle adjustment
The trunk support can be an abductor, an anatomic abductor or a saddle. These components are mutually exclusive. Every one of them can be adjusted in depth and height:
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13.1.6. Pelvis support adjustment
The pelvis support, if present, is adjustable in height and depth:
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13.1.7. Table adjustments
The table is adjustable in height and tilt. The chosen tilt always remains constant from the floor thanks to the pantograph mechanism, independently from the angle of the vertical support.
Once the height of the table has been adjusted, it may be necessary to readjust the height of the harness, the harness support and the table angle |
13.1.8. Back support adjustment
The belt-based back support is adjustable in height and depth:
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OFFCARR s.r.l. reserves the right to make improvements and/or changes on its products, at any time without prior notice, with respect of the device features, suitability, certifications, warranty contract and availability of spare parts according to the terms of law.