SERVICE MANUAL

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Transcription:

SERVICE MANUAL 2017-02

DECLARATION OF CONFORMITY The manufacturer Neatech.it Via A. de Curtis 4/A, 80040, Cercola (NA), Italy declares that the cushion Peezy (reference code: S211) satisfies the requirements laid down by the European Directive 93/42; according to the criteria for classification of Annex IX of this Directive, it is classified as: class I medical device

Index 1 PRODUCT INFORMATION... 1 2 PREPARATION FOR FIRST USE... 2 2.1 Checks to be made on delivery... 2 2.2 Unpacking... 2 3 ADJUSTMENTS... 5 3.1 List of adjustments... 5 3.2 Leg area width... 6 3.3 Pelvic area width... 8 3.4 Pelvic area depth... 10 3.5 Pommel and lateral tight position... 13 3.6 Seat tilt... 15 3.7 Default position... 17 4 USE OF THE PRODUCT... 18 4.1 Use in a motor vehicle... 20 4.2 Mounting on the wheelchair... 22 4.3 Transport and storage... 23 5 MAINTENANCE... 24 5.1 Cleaning... 24 5.2 Re-use... 25 5.3 Spare parts... 25 5.3.1 Upholstery... 26 5.3.2 Cover foams... 28 6 SPECIFICATIONS... 30 6.1 Maximum user weight... 31 6.2 Product weight... 32 6.3 Dimensions... 33 7 Warranty... 34 7.1 Labels... 34 Note... 35

Symbols in this manual WARNING This symbol means presence of danger for the user or damage for the product. Always follow instructions when this symbol is present. INFORMATION This symbol means general information intended to simplify or best explain the use of the product. CONTACT INFORMATION This symbol means the need of contacting an authorized service center or the manufacturer.

TEMPERATURE The temperature of some surfaces may increase when the product is exposed to external heat sources as direct sunlight. Service manual is intended for technical personnel to maintain and repair wheelchairs. It is important to follow the instructions contained in this manual in order to professionally work with the product. The qualified personnel who works with wheelchairs must comply with all provisions of occupational safety and common sense in order to preserve his own safety. The manufacturer declines all responsibility for any accidents occurring during the working with the product. WARNING: It is prohibited to use the product or its parts for any purpose other than that indicated. For a correct use please follow the instructions given in this manual. The manufacturer disclaims any responsibility for damages caused by improper use of the product. The manufacturer disclaims any responsibility for inappropriate selection of product model and configuration.

Information in this manual may be subject to change without notice. All information, pictures and specifications are based on the product details that were available at the time of preparation of this document. They are representative examples and they are not intended to be exactly as the actual product. MODIFICATIONS Any unauthorized modification to the product may increase the risk of personal injury and damage to the product itself. All modifications should be done by an authorized service center. Do not use any unauthorized accessories or spare parts on the product. Do not use the product in combination with other medical devices without first having considered any risk due to combination of more products. MANUFACTURER For any need not expressly explained in this manual, please contact the manufacturer. Neatech.it SRL via A. de Curtis 4/A, 80040, Cercola (NA), Italy info@neatech.it - +39 081 555 1946 INCIDENT REPORTING If an incident occurs, please contact an authorized service center. For a list of authorized service center please contact the manufacturer. DISPOSING This product and all its components can not be treated as household waste. For more detailed information on how recycling and disposal this product contact your local waste disposal service.

1 PRODUCT INFORMATION Extremely modular flat base cushion, completely made of high quality PU material that can be adapted for every user. It is particularly suitable for patients who require side and rear containment, but its modular feature and, therefore, the possible elimination of any insert, ensures extreme comfort to people with less serious diseases. Peezy, positionable on sling seat or a rigid base and with an anti-slip system, present a breathable and stretch textile cover and has a comfortable memory foam and breathable PU padding, to ensure greater comfort to the user. Especially the seamless cover, which it is present in every positioning system of the Buddy Brace line, ensure no harm to the skin. Peezy, ultimately, it has been studied as a set of simple and adjustable inserts, to be composed in blocks according to the most specific user needs. Seamless breathable upholstery Maximum user weight 150 kg Seat width from 26 cm to 48 cm Seat depth from 30 cm to 52 cm 2 years guaranted Figure 1 1/34

2 PREPARATION FOR FIRST USE 2.1 Checks to be made on delivery Check for the integrity of the original packaging. Check for any anomalies on shipping documents. Check for the functionality and integrity of the device in all its parts, at the time of delivery or immediately thereafter, to ensure that no damage has resulted from a careless transport. Make sure the surface of the device is not damaged, scratched, bent, etc. Any fault or damage found must be immediately reported on the shipping documents and promptly communicated to the shipper. 2.2 Unpacking Inside the box there are: Peezy cushion Adhesive bands Documents and manual INFORMATION Some of described parts may be not present because available as accessories and not purchased. For more information please contact the vendor. Before starting to mount the product please check if all described component are present. If not, please contact as soon as possible the vendor. No tool is required for the setup of the product: 2/34

Peezy cushion is provided mounted and ready for the use. For the use it is necessary a wheelchair as a base with a canvas or a rigid plane where to put the cushion. The base of the cushion has some adhesive bands with loop to help fixiing. It is neccesary to mount on the wheelchair the provided adhesive bands with hook put as ones on the cushion. Figure 2 INFORMATION For more information see wheelchair's manual. WARNING Always follow instruction of wheelchair manufacturer. In any case: Operate brakes of the wheelchair and be sure it is securely blocked. If the wheelchair is foldable, always open it. 3/34

WARNING Be sure to put the cushion on the wheelchair in the right direction. (seeing figure front part is on the right) FIRST SET UP It is very important to perform the first set up of the product with the supervision of a technician with rehabilitation knowledge with the aim of discover any problems or needs of adjustments and customization related to the use of the product. WARNING If any skin redness or injury possibly related to the use of the product occur, stop the use of the product as soon as possible and contact a technician with rehabilitation knowledge or a medician. PACKAGING DISPOSAL To properly recycle the packaging materials follow instructions provided by your local waste disposal service. 4/34

3 ADJUSTMENTS 3.1 List of adjustments Peezy cushion is suitable for various user. In fact it is possible to adjust the position of inserts in order to give maximum confort to the user. Adjustments must be performed by a technician with rehabilitation knowledge. Here following there are some advised adjustments. Figure 3 Type of operation A B C Operation intended to be performed by the user. Operation intended to be performed by an assistant. Operation intended to be performed by an authorized service center. Table 1 Adjustment Leg area width Pelvic area depth Leg Pelvic area width Pommel and lateral tight position Seat angle Type of operation C - Authorized service center C - Authorized service center C - Authorized service center C - Authorized service center C - Authorized service center Table 2 5/34

3.2 Leg area width Peezy cushion is modular and can be adapted according to specific needs of single user. Adjustment must be operated by staff with rehabilitation knowledge and must be take into account clinical situation of the user. WARNING This operation must be performed only at an authorized service center. A CUSHION SIZE (A) MIN VALUE (A) MAX VALUE P1 26 cm 30 cm 16 cm 20 cm P2 30 cm 34 cm 20 cm 24 cm P3 30 cm 40 cm 20 cm 24 cm P4 34 cm 44 cm 24 cm 28 cm P5 36 cm 44 cm 26 cm 30 cm A P6 38 cm 48 cm 28 cm 32 cm P7 42 cm 44 cm 32 cm 36 cm P8 42 cm 52 cm 32 cm 36 cm P9 44 cm 50 cm 34 cm 38 cm P10 48 cm 52 cm 38 cm 42 cm Table 3 6/34

Average needed time: 5 min Difficulty level: Easy Figure 4 Remove upholstery. Remove cover foams. Set the position of inserts highlighted in figure as desired. Put back cover foams. Put back upholstery. REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To mount upholstery pull the blocking system toward up the as shown in figure. 7/34

3.3 Pelvic area width Peezy cushion is modular and can be adapted according to specific needs of single user. Adjustment must be operated by staff with rehabilitation knowledge and must be take into account clinical situation of the user. WARNING This operation must be performed only at an authorized service center. A CUSHION SIZE (A) MIN VALUE (A) MAX VALUE P1 26 cm 30 cm 16 cm 20 cm P2 30 cm 34 cm 20 cm 24 cm P3 30 cm 40 cm 20 cm 24 cm P4 34 cm 44 cm 24 cm 28 cm A P5 36 cm 44 cm 26 cm 30 cm P6 38 cm 48 cm 28 cm 32 cm P7 42 cm 44 cm 32 cm 36 cm P8 42 cm 52 cm 32 cm 36 cm P9 44 cm 50 cm 34 cm 38 cm P10 48 cm 52 cm 38 cm 42 cm Table 4 8/34

Average needed time: 5 min Difficulty level: Easy Figure 5 Remove upholstery. Remove cover foams. Set the position of inserts highlighted in figure as desired. Put back cover foams. Put back upholstery. REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To mount upholstery pull the blocking system toward up the as shown in figure. 9/34

3.4 Pelvic area depth Peezy cushion is modular and can be adapted according to specific needs of single user. Adjustment must be operated by staff with rehabilitation knowledge and must be take into account clinical situation of the user. WARNING This operation must be performed only at an authorized service center. A CUSHION SIZE (A) MIN VALUE (A) MAX VALUE P1 26 cm 30 cm 8 cm 11 cm P2 30 cm 34 cm 10 cm 13 cm P3 30 cm 40 cm 12 cm 15 cm P4 34 cm 44 cm 13 cm 16 cm P5 36 cm 44 cm 13 cm 16 cm P6 38 cm 48 cm 16 cm 19 cm P7 42 cm 44 cm 13 cm 16 cm A P8 42 cm 52 cm 17 cm 20 cm P9 44 cm 50 cm 16 cm 19 cm P10 48 cm 52 cm 17 cm 20 cm Table 5 10/34

Average needed time: 5 min Difficulty level: Easy Figure 6 Remove upholstery. Remove cover foams. Remove inserts highlighted in figure. REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To remove upholstery pull the blocking system toward up the as shown in figure. 11/34

Cutter Figure 7 With a cutter, cut the insert previously removed at the desired depth. Repeat operation for both left and right side insert. Put back inserts on the cushion. Put back cover foams. Put back upholstery. 12/34

3.5 Pommel and lateral tight position Peezy cushion is modular and can be adapted according to specific needs of single user. Adjustment must be operated by staff with rehabilitation knowledge and must be take into account clinical situation of the user. WARNING This operation must be performed only at an authorized service center. Average needed time: 5 min Difficulty level: Easy Figure 8 Remove upholstery. Remove cover foams. Set the position of inserts highlighted in figure as desired. It is possible to choose postion and angle. Put back cover foams. Put back upholstery. 13/34

REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To remove upholstery pull the blocking system toward up the as shown in figure. INFORMATION If needed it is possible to remove the insert between right and left part of the pommel in order to reduce its size. 14/34

3.6 Seat tilt Peezy cushion is modular and can be adapted according to specific needs of single user. Adjustment must be operated by staff with rehabilitation knowledge and must be take into account clinical situation of the user. WARNING This operation must be performed only at an authorized service center. Average needed time: 5 min Difficulty level: Easy Figure 9 Remove upholstery. In the standard position the seat angle is 15 forward. If you rotate it 180 you will have a seat angle of 15 backward.if you you remove it you will have a seat angle of 0. Put back upholstery. 15/34

REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To remove upholstery pull the blocking system toward up the as shown in figure. 16/34

3.7 Default position Peezy cushion is modular and can be adapted according to specific needs of single user. Adjustment must be operated by staff with rehabilitation knowledge and must be take into account clinical situation of the user. WARNING Adjustments of inserts must be performed only at an authorized service center. Peezy cushion is provided in standard configuration. Standard configuration should complies with needs of most users. Leg area width: MAX Pelvic area width: MAX Pelvic area depth: MAX Pommel position: in the middle and orthogonal to front edge of the cushion. Lateral tight position: as wider as possible ande and orthogonal to front edge of the cushion. Seat angle: 15 17/34

4 USE OF THE PRODUCT MAXIMUM USER WEIGHT Don t use the product if your weight exceed the maximum user weight written in the specification of this user manual. WARNINGT Do not stand on the product. Always use caution when transferring in or out of the seat. Every precaution should be taken to reduce the transfer distance. Do not let children use the wheelchair without supervision. Do not carry passengers on the seat independently of the age of the passenger. The seat is not sutable for weight carrying. INFORMATION The product is not intended to be dismantled. There are no parts of the product expected to be handled during normal use of it INFORMATION Do not install, maintain or operate the product without reading all warnings and this entire manual. Always keep this manual in connection with the product. 18/34

WARNING If any skin redness or injury possibly related to the use of the product, stop the use as soon as possible and contact a technician with rehabilitation knowledge. POSSIBLE NEGATIVE EFFECTS Often check the skin of the user near contact zones with the product with the goal of discover as soon as possible the formation of any bedsores. In this case stop as soon as possible the use of the product and contact a technician with rehabilitation knowledge or a medician. 19/34

4.1 Use in a motor vehicle Peezy cushion is compliant with ISO 16840-4:2008 and it is suitable for use in a motor vehicle when used with an appropriate wheelchair as a base. For assembly, use, maintenanceand any limitations in using the product see manual of the wheelchair used as a base. It is advised to use both a pelvic belt restraint and shoulder belt restraint. WARNING The product can be used in a motor vehicle only with a ISO 7176-19 compliant wheelchair used as a base. WARNING The product can be used in a motor vehicle only forward-facing. WARNING If the wheelcahir used as a base has a tray you should remove it and secure it separately in the vehicle. WARNING Always follow instructions in this manual and instructions in the manual of the wheelchair used as a base. 20/34

WARNING Both pelvic and shoulder belt restraints ISO 10542-1 compliant shall be used to achieve effective user restraint and optimum protection in a vehicle impact. Belt restraints should be fitted following manufacturer instructions. WARNING You should not use this product in a motor vehicle if your weight is less than 22 kg. 21/34

4.2 Mounting on the wheelchair Peezy cushion must be monted on a wheelchair with a adequate base. The base must be a canvas or a rigid plane. Width of base must be equal or greater than width of the cushion to be mounted. Depth of base must be equal or greater than depth of the cushion to be mounted. WARNING Always follow instruction of wheelchair manufacturer. In any case: Operate brakes of the wheelchair and be sure it is securely blocked. If the wheelchair is foldable, always open it. WARNING Be sure to put the cushion on the wheelchair in the right direction. (seeing figure front part is on the right) 22/34

4.3 Transport and storage If you are not willing to use the product for a long period keep it safe in a clean area and away from heat and humidity. If it is necessary to transport the product, to facilitate the operation, follow these instructions. The product can be transported in the storage compartment of a vehicle even without any package. If it is necessary to ship the product it is very important to protect it with an appropriate package. It is not possible to provide an universal package, so the user can provide itself for it. The used package must be: Water and dust resistant Strong enough to protect the product from any hurts. 23/34

5 MAINTENANCE Please remind that the product is intended exclusively to give user a correct postural support in combination with a wheelchair to be used as a base. Regular maintenance helps to keep intact the functionality and safety of product. Inadequate or lack of care and maintenance may cause a limitation of the warranty from the manufacturer. Below there are some precautions for the use of the product, which it is recommend to follow, to ensure a safe use and a long duration. Avoid prolonged contact of the product with water. Avoid long exposure of the product to direct sunlight. 5.1 Cleaning To clean the product do not use high-pressure water spray devices. Do not use stain removers, solvents, acids, etc. It is possible to remove the upholstery and wash it separately. REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To mount upholstery pull the blocking system toward up the as shown in figure. Washing machine 30 No dry machine Do not wring Do not bleach 24/34

5.2 Re-use The product is suitable for re-use. Previous the transfer of the product, it must be cleaned and controlled by technician with rehabilitation knowledge. The manual must be transferred together with the product. 5.3 Spare parts Type of spare part A B Spare part intended to be substitued by an assistant. Spare part intended to be substitued by an authorized service center. Code Description Type of service Note R211-001 Upholstery A R211-002 Cover foams A WARNING The use of spare parts or accessories not approved by the manufacturer may make the product less safe. For any other parts not described in this manual please contact the manufacturer. 25/34

5.3.1 Upholstery Average needed time: <5 min Difficulty level: Easy Remove upholstery. Put back upholstery. REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To mount upholstery pull the blocking system toward up the as shown in figure. d 26/34

Code Description Notes R211-001A R211-001B R211-001C R211-001D R211-001E R211-001F R211-001G R211-001H R211-001I R211-001J R211-001K R211-001L R211-001M R211-001N R211-001O R211-001P R211-001Q R211-001R R211-001S R211-001T Upholsetry P1 Upholsetry P2 Upholsetry P3 Upholsetry P4 Upholsetry P5 Upholsetry P6 Upholsetry P7 Upholsetry P8 Upholsetry P9 Upholsetry P10 Waterproof cover P1 Waterproof cover P2 Waterproof cover P3 Waterproof cover P4 Waterproof cover P5 Waterproof cover P6 Waterproof cover P7 Waterproof cover P8 Waterproof cover P9 Waterproof cover P10 27/34

5.3.2 Cover foams Average needed time: <5 min Difficulty level: Easy Remove upholstery. Remove cover foams. Set the position of inserts highlighted in figure as desired.put back cover foams. Put back upholstery.. REMOVE UPHOLSTERY MOUNT UPHOLSTERY To remove upholstery pull the blocking system toward down as shown in figure. To mount upholstery pull the blocking system toward up the as shown in figure. 28/34

Code Description Notes R211-002A R211-002B R211-002C R211-002D R211-002E R211-002F R211-002G R211-002H R211-002I R211-002J Cover foams P1 Cover foams P2 Cover foams P3 Cover foams P4 Cover foams P5 Cover foams P6 Cover foams P7 Cover foams P8 Cover foams P9 Cover foams P10 29/34

6 SPECIFICATIONS Expected lifetime 3 years Intended use Peezy cushion is intended exclusively to give user a correct postural support in combination with a wheelchair to be used as a base. Table 6 WARNING It is prohibited to use the product or its parts for any purpose other than that indicated. For a correct use please follow the instructions given in this manual. Manufacturer disclaims any responsibility for damages caused by improper use of product. Manufacturer Address Part Number / Model Neatech.it via A. de Curtis 4/A 80040 Cercola (NA) - Italia S211 - Peezy It is possible to use and store the product when the temperature is in the range specified in following table. Use -25 C +50 C Storage -40 C +65 C Table 7 30/34

6.1 Maximum user weight Seat width Maximum user weight 26 cm 50 kg 30 cm 50 kg 34 cm 75 kg 36 cm 75 kg 38 cm 100 kg 42 cm 150 kg 44 cm 150 kg 48 cm 150 kg Table 8 31/34

6.2 Product weight Size Upholstery and cover foams weight Inserts and base weight Total weight P1 26 cm 30 cm P2 30 cm 34 cm P3 30 cm 40 cm P4 34 cm 44 cm P5 36 cm 44 cm P6 38 cm 48 cm P7 42 cm 44 cm P8 42 cm 52 cm P9 44 cm 50 cm P10 48 cm 52 cm 0.4 kg 0.5 kg 0.9 kg 0.5 kg 0.6 kg 1.1 kg 0.6 kg 0.7 kg 1.3 kg 0.8 kg 1.1 kg 1.9 kg 0.9 kg 1.2 kg 2.1 kg 1.0 kg 1.4 kg 2.4 kg 1.1 kg 1.5 kg 2.6 kg 1.3 kg 1.8 kg 3.1 kg 1.4 kg 1.9 kg 3.3 kg 1.5 kg 2.2 kg 3.7 kg Table 9 WARNING Data may change according to a specific customization of the product and because of tolerances and approssimation of calculation. 32/34

6.3 Dimensions A B CUSHION SIZE (A) WIDTH (B) DEPTH P1 26 cm 30 cm P2 30 cm 34 cm P3 30 cm 40 cm P4 34 cm 44 cm P5 36 cm 44 cm P6 38 cm 48 cm P7 42 cm 44 cm P8 42 cm 52 cm P9 44 cm 50 cm P10 48 cm 52 cm Table 10 WARNING Data may change according to a specific customization of the product and because of tolerances and approssimation of calculation. 33/34

7 Warranty The product is globally guaranteed for 24 months. The warranty covers defects in materials or workmanship. The warranty doesn t cover parts subject to usury or damaged parts by: overload, misuse, alterations and repairs made by unauthorized third parties. The warranty expires in case of tampering, improper storage, unauthorized or incorrect maintenance. 7.1 Labels Inside each cushion there is a label with information about: Manufacturer and its address Part number Serial number Year of manufacturing Maximum user weight For any request related to the warranty or in general to the product please be sure to have available informations in this label. Inside each cushion there is a label with information about: 34/34

Note