SAMEKH Manual.
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Products: Samekh
SAMEKH EN
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.
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OFFCARR srl |
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MADE IN ITALY |
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Distributor: |
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1. Labelling
Sticker position on the shell |
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Product sticker (applied on the shell) |
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UDI sticker (applied on the shell and on the instructions for use) |
Information available on the product sticker: |
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1.1. Symbols description
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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 attachment points for crash tested models. |
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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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To use the device correctly and safely, it is always recommended to clarify any doubts with qualified personnel. |
Hereafter are some suggestions and recommendations for a correct use of the device, also aimed at maintaining its safety and durability characteristics over time:
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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 safety characteristics of the materials involved.
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Avoid contact with seawater and sand. In case of contact, proceed with immediate and thorough cleaning.
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Clean the device with a damp cloth and avoid even partial immersion of the frame. Keeping the device clean increases its efficiency.
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Suspend use of the product and notify OFFCARR in case of allergies or other similar problems due to contact with the materials that make up the device.
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The fabric used for the device’s upholstery is washable with low-temperature water. In any case, avoid wetting or immersing other parts of the device.
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There is no danger of causing injury to people during the operations of preparation and setup of the device, if carried out carefully following the instructions provided in this manual.
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After installing a new seating system, regularly check the condition of the skin; if redness or a skin reaction persists for more than 30 minutes, suspend use and contact the therapist or treating physician.
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Never use the backrest without its cover: the cover protects the user and the product; use without the cover increases the risk of skin injury, reduces the product’s lifespan and makes it more susceptible to flammability.
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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 in this manual. |
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To maintain the device and its safety requirements, it is recommended to uphold a regular maintenance schedule, as described in 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 mechanical or electronic devices on the device that are not approved by OFFCARR, and do not modify its structure in any way. Any combination with other medical devices must be expressly authorized by OFFCARR. If 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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For more information about the connection points and devices needed to secure the device during transport by car (valid exclusively for crash tested models), see 5, “Use in motor vehicles” |
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The backrest must be selected and validated exclusively by a professional experienced in posture and seating systems. Do not use it in direct contact with open wounds or advanced pressure injuries without the opinion of healthcare personnel. Do not use it in case of known allergy to the materials that make up the device. |
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Installing a backrest can change the centre of gravity of the wheelchair it is mounted on and reduce its stability: assess whether anti-tip devices or other stability aids are needed on the wheelchair. |
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Before use, make sure all fastenings are correctly tightened, that the backrest is securely anchored to the wheelchair, and that any quick-release coupling system is fully locked. |
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Do not exceed the declared maximum load of the device (120 kg), even temporarily. |
4. Compatibility with third-party devices
This section applies to OFFCARR devices intended to be mounted on or used together with products from other manufacturers (for example a postural backrest installed on a third-party wheelchair).
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Compatibility with a specific wheelchair or a specific device must be verified before use. OFFCARR cannot guarantee the compatibility, performance or safety of devices produced by third parties when used in combination with its own products. |
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Combined use with devices from other manufacturers is permitted only within the scope of a combination agreement. Contact OFFCARR or your dealer to verify the combination and obtain the relevant instructions. |
5. Use in motor vehicles
The SAMEKH system has successfully passed crash testing in accordance with ISO 16840-4, with a test mass of 120 kg, and can therefore be used as a wheelchair backrest during transport in a motor vehicle.
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Use during transport is permitted only when the SAMEKH backrest is installed on a wheelchair that is itself certified for transport in motor vehicles, using the correct wheelchair tie-down and occupant restraint systems (WTORS) and the pelvic and diagonal safety belts. |
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Installation of the approved components must be carried out by authorized personnel, following the correct technical specifications. |
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The backrest passed the crash test exclusively in the forward-facing direction and with an anthropomorphic test device (ATD) secured with a pelvic belt and a diagonal belt. |
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Do not rely on the backrest or its parts as an occupant restraint system. The safety belts for transport must be anchored to the intended anchor points on the vehicle and on the wheelchair, never to the backrest. |
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After any significant collision, the backrest must be inspected by an OFFCARR representative before further use, to check for damage that may not be immediately visible. |
6. Product presentation
6.1. SAMEKH
Intended use. SAMEKH is a dorsal postural support intended to maintain alignment and improve trunk stability for users of manual or powered wheelchairs in daily use. It is intended for patients who require postural trunk support, following assessment and prescription by a healthcare professional.
Samekh are non-invasive medical devices specifically designed to reduce and counterbalance motor impairments in the medium and long-term.
Configuration and adjustment must be performed exclusively by qualified personnel.
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It is forbidden to use the device or its parts in different ways from those described in this manual. |
SAMEKH is the line of postural backrests developed and manufactured by OFFCARR for the specific needs of active users. Listening to individual needs, the study (clinical and empirical) of the interaction between person, wheelchair and environment and the search for essential lines converge in an effective, light and elegant solution.
SHELL Made of carbon fibre or aluminium alloy, it is light and breathable thanks to the large holes which define its appearance. The aluminium shell, which is usually black, can be requested in the same colour as the wheelchair or in another colour for custom looks. The lighter and more flexible carbon fibre body also gives the wheelchair a unique aesthetic character. The slightly backward bent upper edge avoids localised pressure during transfers and when dressing. The upper edge is designed to free the shoulder blades, allow agile movements in all directions and make full use of the thrust arc to improve push efficiency. The lower edge adapts to the lumbar section thanks to the contoured profile, freeing the buttocks and resting on the SIPS to induce an active posture and distribute support pressure.
PADDING The materials have been chosen to maximise microclimate control and breathability as well as controlling immersion and support. It is divided into three layers; the first and thickest is composed of an open-cell foam to dynamically support the torso. The second material is a three-dimensional,stiffer material that distributes the forces over the entire support surface. The lining, made of a breathable technical fabric, contains the other layers with the correct tension. All the padding is easily removable and washable.
SAMEKH SIZES the backrests are available in widths between 26 and 46 cm, each in three lengths of 24, 30 and 36 cm. Each size is available in three profiles: ACTIVE 6cm deep, DEEP 9cm deep and EXTRA DEEP 18cm deep.
MOUNTING POINTS Available for all SAMEKH backrests is a central single mounting point, which can be removable or fixed, as well as removable lateral double mounting point. The side mounts are designed to be space-saving while maintaining a wide range of adjustment and ease of use and application. They are compatible with folding or fixed wheelchairs with tube diameters from 19 to 28 mm. The side attachments are adjustable in height, depth and tilt in both sagittal and frontal planes. The central attachment is specifically for fixed-frame wheelchairs. It is elegant and minimalist and is quick to insert and remove. It can be installed on various points of the shell to adjust the mounting height. The tilt can only be adjusted in the sagittal plane and is constrained and possibly limited by the position of the attachment point on the wheelchair.
6.1.1. Features
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2 ultralight shell options:
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Aluminium
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Carbon fibre
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2 frame depth:
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Active
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Deep (Aluminum version only)
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2 fastening clamps type
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Single central attachment (fixed or detachable)
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Double lateral attachment (detachable only)
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6.2. Product codes
PRODUCT CODE (SK M T LL HH) |
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SK |
M |
T |
LL |
HH |
(MATERIAL) |
(TYPE) |
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A: Aluminium |
A: Active |
Width |
Height |
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C: Carbon fibre |
D: Deep |
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X: Extra Deep |
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6.3. Effective measurements
All measurements are in cm |
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6.3.1. Tab. LH Measurements for SAMEKH, length 24 cm DEEP profile 100 mm depth
Backrest width |
22 |
24 |
26 |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
46 |
R |
Tab. KD |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
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M |
Tab. KD |
11,5 |
11,5 |
11,5 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
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H |
Tab. KD |
24 |
24 |
24 |
24 |
24 |
24 |
24 |
24 |
24 |
24 |
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6.3.2. Tab. MH Measurements for SAMEKH, length 30 cm DEEP profile 100 mm depth
Backrest width |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
46 |
R |
13,5 |
13,5 |
13,5 |
13,5 |
13,5 |
14 |
14 |
14 |
14 |
14 |
M |
18 |
18 |
18 |
18 |
18 |
18 |
18 |
18 |
18 |
18 |
H |
30 |
30 |
30 |
30 |
30 |
30 |
30 |
30 |
30 |
30 |
6.3.3. Tab. HH Measurements for SAMEKH, length 37 cm DEEP profile 100 mm depth
Backrest width |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
46 |
R |
16 |
16 |
16 |
16 |
16 |
16 |
16 |
16 |
M |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
H |
37 |
37 |
37 |
37 |
37 |
37 |
37 |
37 |
6.3.4. Tab. KD Measurements for SAMEKH, under 28 cm width, DEEP profile 85 mm depth
Backrest width |
22 |
24 |
26 |
R |
10 |
11 |
12 |
M |
17 |
20 |
23 |
H |
19 |
22 |
24 |
6.3.5. Tab. ACT-L Measurements for SAMEKH, ACTIVE profile
Backrest width |
22 |
24 |
26 |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
46 |
L1 |
22 |
24 |
26 |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
46 |
L2 |
20 |
22 |
24 |
26 |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
A |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
7,5 |
L1 = Max width |
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L2 = Shell width |
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A = Effective contour depth |
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Measurements in cm |
6.3.6. Tab. DEP-L Measurments for SAMEKH, DEEP profile
Backrest width |
22 |
24 |
26 |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
46 |
L1 |
22 |
24 |
26 |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
46 |
L2 |
20 |
22 |
24 |
26 |
28 |
30 |
32 |
34 |
36 |
38 |
40 |
42 |
44 |
A |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
L1 = Max width |
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L2 = Shell width |
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A = Effective contour depth |
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Measurements in cm |
7. Components
7.1. Lateral mounting hardware
Lateral mounting points are suitable for assembly of the SAMEKH system on folding wheelchairs or if the backrest bar is not present, not accessible or not suitable on rigid frame wheelchairs.
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7.2. Central attachment
The central attachment is suitable for assembly of the SAMEKH system on rigid frame wheelchairs with the backrest bar. This bar must be accessible and in a convenient location. If not, lateral hardware is available.
SAMEKH with central attachment is generally removable, with a latch to lock it in place.
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7.3. Central attachment (FIXED)
A fixed central attachment (non-removable) is also available.
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8. Preparing for use
This section describes the daily operations of inserting, locking and removing the SAMEKH backrest on the mounting brackets (central or lateral) already installed and adjusted on the wheelchair. The first installation and the adjustment of the brackets are described in the dedicated section.
Before each use, make sure that the brackets are correctly installed on the wheelchair and that all fixing screws are tightened.
8.1. Inserting and locking the backrest
The removable brackets (central or lateral) allow the backrest to be inserted and removed quickly and without tools.
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Align the backrest plates with the guides of the brackets mounted on the wheelchair.
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Slide the backrest into the guides until it stops.
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Check that the locking hook has clicked correctly into place, securing the backrest against accidental extraction.
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Before sitting down, always check that the backrest is fully inserted and that the locking system is actually engaged. |
8.2. Removing the backrest
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Release the locking hook.
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Slide the backrest out of the guides, extracting it from the brackets.
9. Cleaning instruction
SHELL
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Wash the shell 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 shell prior to further processing
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Visually inspect the cleanliness of the complete shell
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Disinfect the shell using 70-90% alcohol
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Clean the attachments and fastenings with a damp cloth
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Be sure it is completely dry before proceeding with use
UPHOLSTERY
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The cover and padding are machine washable at 40°C on a delicate fabrics program with detergent for delicate fabrics.
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It is recommended to wash individually the three components that make up the upholstery i.e., the outer cover, the inner front layer made of 3D material, and the lower layer made of open-cell polyurethane.
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Allow the complete upholstery (or individually the component parts) to air dry, do not tumble dry it.
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Machine wash (delicate) |
Maximum water temperature 40°C |
Do not tumble dry |
Do not bleach |
Do not iron |
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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. |
10. Maintenance, inspections and controls
Monthly:
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✓ Inspect the backrest (shell, padding and cover) to verify the absence of functional or aesthetic defects and material degradation.
Every 6 months:
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✓ Check all mounting fasteners and clamps for wear, looseness or damage, and retighten them to the prescribed torque.
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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. |
11. 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.
12. 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 2 (two) 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.
13. 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].
14. Material differentiation
OFFCARR products are made of aluminium alloy (Al 7020, Al 6082, Al 2017, Al 6061, Al 5754), titanium, steel (AISI 303), carbon fibre, polyurethane, epoxy resins, other composite materials.
The separation and disposal of materials must be in compliance with the local applicable laws.
Contact your dealer in case of doubt or for help when disposing the device.
15. Installation and adjustments
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Please refer to authorized and qualified personnel to perform any type of adjustment on the backrest. |
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Consider consulting a seating and positioning expert both when evaluating the best seating position (in each specific case) and when performing the following adjustments. |
15.1. Lateral mounting hardware
Lateral mounting points are suitable for assembly of the SAMEKH system on folding wheelchairs or if the backrest bar is not present, not accessible or not suitable on rigid frame wheelchairs.
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15.1.1. Preparation
Before proceeding with the installation of the backrest, it is necessary to pre-assemble the brackets on the shell. Remove the padding and place and screw the hardware onto the shell in the centered position, leaving the screws loose (so that other adjustments can be performed later); reposition the padding.
15.1.2. Installing the clamps on the frame
The clamps can fit tubes between 19 and 27 mm in diameter. There must be 50 mm of free space (vertically), and 4 mm of outer clearance; an extra plastic sleeve is provided for clamping on 21 mm diameter tube. To define where to place the clamps on the backrest bars, it is advisable to roughly position the backrest at the desired height and seek a position that is as centred as possible (relative to the shell). This will facilitate subsequent adjustments. The mounting of the clamps on the uprights should be symmetrical (right and left) so that the support points work on the same plane. This makes removal and insertion agile and quick.
15.1.3. Backrest height adjustment
The shells of SAMEKH systems have slots to accommodate the attachments. These allow for a backrest height adjustment of 70 mm. If the adjustment allowed by the slots on the backrest is not enough, the position of the clamps on the uprights of the wheelchair must be adjusted.
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15.1.4. Depth and tilt adjustment
It is possible to adjust both the depth and tilt of the backrest at the same time. Loosen the screws that lock the adjustment plates without removing them in order to find the preferred position of the backrest. Once the position has been achieved, tighten the screws appropriately; remove and reinsert the backrest to ensure both operations are smooth. |
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NOTES: - Asymmetrical adjustments of the adjustment plates can affect the smoothness of extraction making it stiff. In this case, perform the adjustment again and correct the asymmetry. - The previous adjustments can also be performed with the user seated in the wheelchair. |
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15.2. Central Attachment
The central attachment is suitable for assembly of the SAMEKH system on rigid frame wheelchairs with the backrest bar. This bar must be accessible and in a convenient location. If not, lateral hardware is available. |
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15.2.1. Installation of the clamp on the wheelchair bar
The clamp is equipped with adapters to accommodate tubes between 19 and 26 mm in diameter. The clamp requires a free tube segment of 70 mm, and the outer clearance beyond the tube is 6 mm. The clamp should be placed in the center of the wheelchair backrest bar with the slide plane approximately perpendicular to the ground plane and the mounting screws kept loose to facilitate subsequent adjustment of the backrest position and angle.
15.2.2. Backrest height and depth adjustment
SAMEKH frames are designed so that the central mounting point can be installed at three different heights. Before proceeding, select the most suitable. Once the height is defined, the depth of the backrest can be chosen using the combination of adapter shims supplied with the attachments. Once the height position and the sequence of shims have been selected, the mounting point must be permanently fastened to the shell by tightening the fastening screws. It is easier to perform this operation on a work table with the backrest detached from the wheelchair.
15.2.3. Tilt adjustment
The tilt of the backrest should be adjusted with the backrest installed; rotate it to the desired angle. It is best to perform the adjustment with the user on the wheelchair, so that the final seating position can be evaluated correctly. Once the correct position has been achieved, tighten the screws that secure the clamp on the wheelchair bar. |
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15.3. Lateral supports
15.3.1. Mounting Swing away lateral supports
Swing away lateral supports can be purchased already mounted on Samekh backrest or can be installed separately.
To install the lateral supports, remove the upholstery, then fix the plate A to the backrest B through the screws C, paying attention to positioning the washers D and the spacer E as shown in the picture. The nuts F should be inserted in the pre-drilled buttonholes on the backrest B in order to lock their rotation. When the support (or both) is appropriately fastened, reseat the upholstery on the backrest. |
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15.3.2. Mounting Extra deep lateral supports
Extra deep lateral supports should be purchased already mounted on Samekh backrest; they can be installed separately only by replacing the upholstery with a suitable one.
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To add Extra deep lateral supports to a Samekh backrest, it should already be the Deep version, and it always requires replacement of the upholstery. |
To install the lateral supports, remove the upholstery, then fix the plate A to the backrest B through the screws C, paying attention to positioning the washers D as shown in the picture. The nuts E should be inserted in the pre-drilled buttonholes on the backrest B in order to lock their rotation. When the support (or both) is appropriately fastened, replace the upholstery on the backrest. |
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Any serious incident occurring in relation to the device must be reported to the manufacturer OFFCARR and to the competent authority of the Member State in which the user and/or the patient is established. |
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.
IFU_OFFCARR_SAMEKH_EN_R0