flowen Knee Pillow Class I Medical Device Instructions
- June 5, 2024
- flowen
Table of Contents
flowen Knee Pillow Class I Medical
**Device Instructions**
Knee Pillow
WARNINGS
PILLOW KNEE
INTENDED USE
Class I medical device intended for use in the private setting and / or facilities enabled for medical exercise as an ergonomic knee pillow, suitable for ensuring a more comfortable rest and preventing pain caused by an incorrect position during sleep. The pillow is placed between the knees thus reducing stress on the spine and leg joints. This peculiarity gives the pillow therapeutic properties and is also suitable for subjects destined for long hospital stays and with postural problems.
The pillow is a CLASS I MEDICAL DEVICE.
DEVICE FEATURES
- Internal padding: Memory Foam
- External pillowcase: in polyester-bamboo fabric
Pillow dimensions (cm): 25 x 20 x 14
The weight of the pillow is 250gr.
RULES OF USE
- The knee pillow can be used on any type of bed / mattress, as long as it is clean and sanitized.
- Mold finds its best environmental conditions in humid places where air does not circulate, therefore it is necessary to respect the maintenance instructions and air the room where the pillow is located daily.
- For greater comfort and durability, it is advisable to ventilate the bedroom every morning for 10/15 minutes.
USE
Place the pillow between your knees, after lying on the bed, on your side. There are no other methods of use to be specified in the manual.
CLEANING / MAINTENANCE
Any stains can be cleaned with a neutral detergent to be removed with a damp cloth. Gently ru b the area with the stain, being careful not to alter the fabric. This operation, if not carried out with due care, can cause the formation of a halo on the fabric that does not create any damage other than aesthetic and in any case the occurrence is not covered by warranty.
The outer covering can be washed by hand or in the washing machine at 30 °. Do not dry clean. Do not spin. Do not tumble dry. Dry away from direct sunlight. The coating can be stretched only at low temperatures.
Keep away from sources of heat or naked flames.
In the event that threads or textile fibers protrude from their original
housing are noticed on the cushion, if they cannot be replaced in their place,
they must absolutely not be pulled or torn, if necessary it is necessary to
remove them, they must be cut using the utmost care a pair of scissors.
STORAGE
- When not used for a long time, the pillow must be stored inside a suitable protective wrapper.
- Store the pillow indoors, away from atmospheric agents and steam jets.
- Keep the pillow away from heat sources, naked flames and direct sunlight.
RESIDUAL RISKS
During the design and production phase of the medical device, the manufacturer carried out an in-depth risk analysis on the same. From this analysis, risks that cannot be eliminated due to their nature emerged. These risks have therefore been examined individually, and guidance on how to avoid them has been emphasized in this document. It is therefore important that any user / operator responsible for the use and maintenance of the medical device has previously read the manual. There were no side effects or contraindications resulting from the use of the pillow to be reported in this document.
CONTRAINDICATIONS
No contraindications were found to be reported in the manual.
SIDE EFFECTS
No side effects were found to be reported in the manual except those that may result from the use of the product by people allergic to the materials used in the pillow and its cover. In case of skin redness or blistering, stop using the pillow and consult your doctor.
LIMITS OF D.M.
- If used according to the instructions given in this manual, the cushion will keep its performance unaltered for at least 3 years. Afterwards, replacement is recommended.
- The pillow does not cure any disease or physical problem but improves the comfort of patients who use it by preventing postural problems and back pain thanks to its structure that allows the spine to remain in the correct position.
- The pillow belongs to the category with a static surface, therefore without movement except in response to the pressure exerted by the weight of the legs of the person using it.
DISPOSAL
The materials of construction of the cushion do not require special disposal procedures. It is necessary to refer to the local regulations for the disposal of unsorted waste. Consult the waste collection center in your locality. Do not dispose or abandon the product in the environment for any reason. The possibility d i reusing some parts of the medical device is subject to the total responsibility of the user.
WARRANTY
The warranty rules, listed in full in the purchase contract, are valid only if the pillow is used in the conditions of intended use.
With the exception of routine maintenance operations described in section Cleaning / maintenance and performed with the procedures indicated, any repair or modification made to the cushion by the user or by unauthorized companies will invalidate the warranty. The warranty does not extend to damage caused by inexperience or negligence in the use of the medical device, or by poor or omitted maintenance.
The products sold by us are covered by warranty with respect to the device under the following conditions:
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The guarantee is valid for a period of 12/24 months depending on the type of buyer (legal or private).
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The warranty includes the repair of defective parts or, only if this is not possible, the replacement of the cushion; the customer must send, when requested, photographic documentation and a precise description of the defect attached to the invoice or receipt and to the aforementioned booklet.
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In the event of repair or replacement, the transport of the pillow is the responsibility of the user, in the event that he uses a carrier agreed with the manufacturer, the pillow must be packed to avoid further damage;
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During the warranty period, replaced products become the property of the manufacturer.
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This guarantee can only benefit the original purchaser who has complied with the instructions for normal maintenance contained in the manual. Our warranty liability expires when: the original owner relinquishes ownership of the product, or changes have been made to the product.
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The warranty of the cushion (inside and cover) does not include damage resulting from poor maintenance, poor hygiene conditions or inappropriate use of the product, such as any damage caused by liquids of any kind, humidity and mold, smoke cigarette or pollution, from excessive stress / rubbing and from the use of unsuitable methods of exercise or not provided for in the leaflet
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The manufacturer assumes no responsibility for any difficulties that may arise in resale or use abroad due to the provisions in force in the country in which the product was sold.
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The product or part of the defective product must be delivered to the manufacturer for replacement; otherwise the replaced part will be charged to the buyer.
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The warranty covers manufacturing defects or permanent alterations that indisputably affect the performance of the pillow. The warranty does not cover variations in lift 6 due to use over time and any hollows in the user surface not exceeding 2 cm. In order to adapt to the weight and body conformation of the user and consequently offer the maximum of its comfort performance, the pillow technically needs a period of systematic use of the sleeping surface of between 10 and 30 days, therefore any initial sensations of compactness of the padding are to be considered normal.
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The warranty is void if the cushion is used on an unsuitable and / or poor quality base that is not resistant and uniform and tends to yield / deform with the user’s load. The guarantee is also void if the cushion is not in perfect hygienic conditions and / or has
organic stains. -
In the event of replacement / repair of the product, the duration of the warranty remains the original one calculated from the date of purchase.
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Small aesthetic imperfections of the product even if detected at the origin, unstitching caused by use and rubbing with other textile surfaces and in any case defects in general that do not compromise the performance of the pillow during rest are not covered by the warranty.
Notice: if it is deemed necessary to use the guarantee, please write to FBC S.r.l. Headquarters: Via Eugenio Montale, 84 -73048 – Nardò (LE) indicating / attaching the following data / documents:
- Product name and / or digital photo of the descriptive adhesive label on the pillow
- Digital photo and / or Photocopy of proof of purchase (receipt and / or invoice)
- Detailed description of the defect found
- Digital photos of the pillow defect
MANUFACTURER’S DATA
Company name FBC S.r.l.
Registered office Via Mauro Macchi, 8 – 20124 Milano (MI) Italy
VAT number 05006680754
Email [email protected]