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APTA: Instructions for use

838ef43c 09-07-2024 10:40:09 UTC +1

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.

Before using or making adjustments on this device, read this instruction manual carefully.

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.

Manufacturer symbol

OFFCARR srl
Via dell’Artigianato II, 29
35010 Villa del Conte (Padova) Italy
Tel. +39 049 9325733 Fax +39 049 9325734
Email: offcarr@offcarr.com
www.offcarr.com

Origin country symbol

MADE IN ITALY

Distributor symbol

Distributor:

Space for distributor info

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.

Sticker position on the product frame

Stickers position on the product frame

Identification sticker

Product sticker (applied on the frame)

UDI sticker

UDI sticker (applied on the frame and on the instructions for use)

Information available on the product sticker:

Manufacturer
Read the instructions
Maximum load
CE symbol
Serial number

Manufacturing date
Medical device
UDI number
Model

1.1. Symbols description

Read the manual symbol

Please read all instructions before using the device. Read all Cautions and Warnings carefully.

CE symbol

European Conformity - The symbol denotes conformity to European standards.

WARNING symbol

WARNING: Read carefully and follow the indications.

NOTE symbol

NOTE: Auxiliary information.

Medical device symbol

Medical Device

UDI symbol

UDI: Unique Device Identifier

Serial number symbol

Serial Number

Order number symbol

Reference - The symbol indicates the model of the product.

Origin country symbol

The symbol indicates the country of origin.

Distributor symbol

The symbol indicates the distributor of the product.

Manufacturer symbol

The symbol indicates the manufacturer of the product.

User Weight symbol

The symbol indicates the maximum load permissible for the product.

Weather symbol

The symbol denotes the importance of protecting the packaging and the product from harsh weather.

Tall and Fragile symbol

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

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:

The brakes only have a parking purpose and should never be used as service brakes to slow down the device in motion.
Do not lean too far forward, because by moving the centre of gravity, the device could tip-over.
The device should be used only in accordance with what is proposed in this manual and not of objects in general.
Always deal with slopes above 6° with assistance from an attendant. This limit is only approximate and it depends on the specific configuration of the device, especially on the position of the centre of gravity of the user-wheelchair combination.
To ensure the efficiency of the brakes, maintain the tyres properly inflated and quarterly check the knurled locking pin wear.
Never use the anti-tip devices, if available, as transit wheels.
The armrests, if available, are not designed to lift the device.
Avoid wheeling the device without the supervision of an attendant.
Perform a general check of the device at least every three months, by checking tyre inflation, efficiency of the quick-release axles and brakes; lubricate the moving parts whenever necessary.
If necessary, the upholstery can be washed with water at low temperature. Avoid wetting or submerging other parts of the device.
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.
Avoid contact with seawater and sand. In case of contact proceed to an immediate and accurate cleaning.
Clean periodically the device using a damp cloth and avoid even partial immersion of the frame. Keeping the device clean enhances its efficiency.

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.

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.

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.

Keep the device away from heat sources, as not all the components are fireproof.

Upholstery materials comply with the EN 1021-2:2014 regulation.

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

It is forbidden to use the device or its parts in different ways from those described on this manual.

Do not use the brakes, if available, to slow down the device at any speed. They are only designed as parking devices.

Do not use the armrests, if available, to pick the device up or as clamping spots.

Never use the anti-tip devices, if available, as transit wheels. It is not their intended purpose.

It is suggested to frequently check the working order of the quick-release wheel devices, especially after each insertion.

The gap between wheels and side-guards or brakes could be lower than 25 mm. Be careful not to put your fingers between the wheels and side-guards or brakes to avoid injury.

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.

To maintain the device efficient and maintain its safety requirements it is recommended to uphold a regular upkeep schedule, as described by this manual.

Poor maintenance and improper use of the device can cause damage or injury to the user or assistant.

Any tampering with the components of the device, as well as voiding the warranty, could compromise its structural integrity and safety standards.

Contact OFFCARR in case the maximum user weight is exceeded at any point during the device’s lifespan.

Contact OFFCARR or your reseller to check for compatibility with accessories produced by a manufacturer different from OFFCARR.

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.

The device and its accessories are not suitable for use in hyperbaric chambers under any circumstances.

In case of prolonged exposure to the sun, the surface of the device can reach high temperatures.

The device is not designed and certified for use as forward-facing seat on a motor vehicle.

Before transferring to or from the device, activate the parking brakes. Always perform transfers with caution.

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).

For technical and aesthetic reasons the pushing handles may be placed at a height lower than 900 mm from the ground.

Headrests (optional) are not approved for use as headrests on moving vehicles.

The tip assist pedal and anti-tip devices are optional accessories that must be requested when ordering the device.

Do not exceed the weight limit of the devices even temporarily. For example, do not perform activities such as weightlifting on the devices.

4. Product presentation

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5. Preparation for use

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.

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5.1. 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.

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5.2. Replacement of tyre and inner tube

5.2.1. Removing the tyre and inner tube

Deflate the wheel
Insert a special lever between the rim and the shoulder of the tyre so that when the lever is overturned, the side of the tyre comes out (fig. 1 and 2).

Tyre/tube disassembly 1

Tyre/tube disassembly 2

Insert another lever 100mm away from the previous point and repeat the operation (fig.3).
Slide the two levers along the circle to free the entire shoulder of the tyre.

Tyre/tube disassembly 3

Extract the inner tube, starting from the side opposite the inflation valve (fig. 4).
Once the inner tube has been extracted, it is easy to remove the tyre to replace one or both of them.

Tyre/tube disassembly 4

5.2.2. Assembling the inner tube and tyre

Insert the (partially deflated) bladder into the tyre (fig. 5)
Insert the chamber inflation valve into the hole on the rim.
Insert one side of the tire entirely on the rim, paying attention to the direction of the tire tread pattern depending on whether the push wheel is right or left.
Insert the opposite shoulder on the rim as well, starting from the point where the valve is positioned and continuing in both directions.
Insert the last part of the shoulder with the help of the special levers by following the instructions represented in Fig. 3, Fig. 2 and Fig. 1 backwards.
Inflate the wheel to the pressure indicated on the side of the tyre.

Tyre/tube assembly

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5.3. Replacing rear wheel bearings

Disassembly

The bearings in the push wheels (B1 and B2) are press-fit. To extract them it is necessary to push them from the inside with the aid of an extractor or a pin punch and a hammer.

Assembly

Position the new bearing B1 on the inside of the hub so that it is coaxial with the hub and apply pressure to seat it.
Before positioning the second bearing B2 insert the axle A to use it as a guide for the second bearing and to ensure coaxiality of the system.

5.4. Quick extraction devices

5.4.1. Check

The quick extraction axles are shipped already checked and adjusted. However, it is recommended to periodically verify the effectiveness of their operation.

Make sure that the X button is fully released once the wheel is correctly mounted.
Check the effectiveness of the latch by trying to pull the wheel outward without pressing the button and make sure it does not slip off.

Wheel removal diagram

5.4.2. 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.

Wheel pin scheme

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.
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.

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.

6. Cleaning instruction

Cleaning and disinfection procedure have to be performed exclusively by qualified personnel.

Follow the instructions on this manual to perform the cleaning and disinfection procedure.

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:

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

Wash the device with lukewarm water and neutral detergent using a damp cloth to remove gross soiling
Remove eventual detergent residuals only with lukewarm water
Dry the device prior to further processing
Visually inspect the cleanliness of the complete device
Disinfect the device using 70-90% alcohol
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:

Wash, rinse, dry and disinfect the upholstery using the same process used for the frame
Be sure the upholstery parts are completely dry before reassembling them

In case of different user after the cleaning treatment:

The best course of action is to change the upholsteries with a new set

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.

All waste materials related to this process must be disposed in compliance with specific local applicable law.

7. Technical service

For any service request, please contact OFFCARR supplying the following indications:

Model
Serial number
Fault description
Any reference or order number, if available, recorded on the order form.
Dealer

Every component of the device is available as spare part.

8. Warranty terms

It is strongly advised to register the product on the website www.offcarr.com after delivery.

The label showing the serial number, the manufacturer address and the CE symbol cannot be removed for any reason to preserve the warranty validity.
Parts subject to normal wear and tear are not covered by the warranty, unless specific wear is caused by evident manufacturing fault.
During the warranty period OFFCARR may proceed at its own discretion to change or to repair the faulty parts.
The warranty does not cover damage due to negligence, carelessness, misuse or by incorrect maintenance performed by non authorized personnel.
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.
The warranty does not cover injury or any other damage to people or goods connected to the device’s malfunctioning.

9. 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].

10. 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.

11. Adjustments

Considering potential setup restrictions it is still possible to perform other adjustment to hone in the wheelchair to the specific user.

Please refer to authorized and qualified personnel to perform the adjustments described in this manual.

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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.