OSKA Series1 Advance Mattress Instruction Manual

June 12, 2024
Oska

Instructions For Use
Series1 Advance MattressOSKA Series1 Advance Mattress

Part Number: PR13-054-055-066
Version: 1.0
Date: 14.07.2023

WARNING!
To avoid injury, before using the device always read this Instructions For Use and any associated documentation.
Mandatory to read the Instructions For Use
Series1 Advance Mattress Instructions For Use

Explanation of symbols and statements

WARNING/CAUTION
WARNING: A statement that alerts the user to the possibility of serious injury or other adverse reaction with the use or misuse of the device.
CAUTION: A statement that alerts the user to the possibility of a problem arising from the use or misuse of the device.

| Manufacturer| | Do not iron
---|---|---|---
| Foot end| | Tumble dry – Low Heat
| Refer to User Manual/Instructions for Use| | Prevention: Category high /very high risk
| Catalogue number| | Resistant to ignition
| Do not use phenol or phenolic-based cleaning solutions.| | Wipe down in line with cleaning and disinfection instructions
| Machine wash at 95°C| | V- G uard Technology
| Drip dry| | Recycling
| Routine disinfection at 1,000ppm available Cl| | UKCA marked indicating conformity to the UK Medical Device Regulation’
| Medical Device according to European and UK Medical Device Regulations| | Batch code
| Date of manufacture| | Does not contain natural rubber latex
| Non sterile| | Maximum user weight

Product description

The OSKA Series1 Advance is a full mattress replacement.
It consists of a modular, castellated, polyurethane foam core, protected by a removable, water resistant, 4-way stretch, moisture vapour permeable cover with welded seams.OSKA Series1 Advance Mattress -
description

Indications for use

The OSKA Series 1 Advance mattress is indicated as an aid for the prevention of pressure ulcers in patients/residents up to a maximum weight of 240Kg (38 Stone). The bariatric version of the mattress is suitable for patients up to 250Kg (40 Stone).
It can be used for a wide range of patients/residents including those identified as ‘high’ and ‘very-high’ risk of pressure related tissue injury (pressure ulcers).
NOTE: The above guidelines should not replace clinical judgement, or the experience of care staff and the product should be used by healthcare professionals as part of a comprehensive pressure ulcer prevention and management care  bundle. Patients at an elevated risk of pressure ulcers should have an individualised plan of care which addresses their specific pressure area care needs.
Patient progress should be regularly monitored and reviewed, and their care plan adjusted to reflect changes in their medical condition(s) and any associated changes to their pressure area care needs.

Warnings, cautions and information
The following warnings, cautions and information should be observed on a routine and regular basis, not just upon mattress installation.

WARNING:| OSKA advise against smoking whilst on or near the mattress. Cigarettes, lighters,  matches and naked flames are all sources of  ignition and could ignite clothing, bed  linen, blankets, duvets etc.
NB. Other external sources of ignition such as exposed heating elements in electric  fires, open fires, lamps/light bulbs and electrical  appliances should also be kept away  from the mattress.
---|---
WARNING:| The mattress cover is not freely air permeable and may present a suffocation risk if used incorrectly. The healthcare professional  responsible for the patient must ensure this product is suitable for the user and that they can safely use this product.
WARNING:| The customer is responsible for ensuring that the OSKA mattress is compatible with the bed frame it will be placed upon. For  example, ensure that the mattress length and width are appropriate for the bed frame and that use of the OSKA mattress on the bed frame does not result in any additional risk to the patient in terms of injury, entrapment, falls etc.
NB. Refer to the bed frame manufacturers recommendations on mattress sizing.
CAUTION:| Do not modify the mattress in any way or use it without the cover.
CAUTION:| Do not allow sharp objects to penetrate the mattress cover.
CAUTION:| Do not use abrasive cleaners, biological or phenolic based cleaners.
INFORMATION:| Set up the mattress as directed. Once set up, the mattress does NOT need to be turned or rotated on the bed frame.
INFORMATION:| Do not place heavy objects on the mattress when not in use.
INFORMATION:| The mattress should be cleaned regularly and always between patients.
INFORMATION:| Note to the user and/or patient: any serious incident that has occurred specifically in relation to this device should be reported to the manufacturer (or where appropriate, the importer or distributor) and the UK MHRA or the relevant competent authority of the  EU member state in which the user and/or the patient is established.

  1. Remove all packaging prior to use. To prevent damage to the mattress or cover, avoid using a knife, or other sharp blade when removing packaging.
  2. Remove existing mattress from bed frame and ensure there are no sharp edges or accessories on the bed frame which may damage the mattress cover.
  3. Place the OSKA mattress directly onto the bed frame with the printed mattress cover facing upwards and the ‘foot end’ symbol at the foot end of the bed.
  4. Ensure the mattress zip is covered by the flap on the cover before placing a sheet on the bed.

Routine checks
Inspect the mattress cover regularly for signs of damage or wear which could result in contamination of the foam inner.
Unzip the mattress cover regularly and inspect the inside of the mattress top cover and the underlying foam for signs of ‘strike through’ (i.e. marking / staining / soiling on the inside of the cover and/or underlying foam). Strike through  indicates damage to the mattress top cover allowing ingress of fluid into the mattress.
Replace any damaged covers immediately.
Where the internal foam has been contaminated it should be removed from service immediately. Follow local guidelines on decontamination or dispose of the mattress in line with local policy and replace with a new one.

Decontamination: cleaning, disinfection and washing

Cleaning
Using a damp cloth or disposable wipe, moistened with neutral detergent and water, wipe down all external surfaces of the mattress. Ensure all organic matter has been removed and the cover is clean. Air dry or use paper towels to dry  thoroughly prior to re-use or storage.
Disinfection
Where there is a need to disinfect the mattress, according to its level of contamination and in line with any local guidelines, OSKA recommend using a 1,000 parts per million (ppm) available chlorine solution such as sodium hypochlorite  (NaOCl). After disinfection, wipe off any residue with clean water and air dry or use paper towels to dry thoroughly prior to re-use or storage.
NOTE: V-Guard covers can tolerate up to 10,000ppm available chlorine but using a weaker chlorine solution will reduce the risk of high concentrations of aggressive chemicals remaining on the surface.
Washing and tumble drying
Covers can be removed and laundered for cleaning and/or thermal disinfection at wash temperatures not exceeding 95°C .
Washed covers can be tumble dried on a low heat setting. Covers to be removed from the tumble drier as soon as they are dry. Do NOT leave them in contact with the heated drum of the drier. Do NOT iron covers.

Servicing
There are no specific servicing requirements for this product. Refer to ‘Routine checks’ and ‘Decontamination’ sections of these Instructions For Use.
For clarification of any information contained within this Instructions For Use document and for any additional questions please contact OSKA’s Technical Service directly on 02394 318 318.
Warranty
All product sales are covered by OSKA’s standard terms and conditions, a copy of which is available from the website (www.oska.uk.com) or on request.
The warranty is based on statutory regulations and does not apply if the goods supplied by OSKA are processed, handled or modified in any way by other parties without prior consent from OSKA or if these Instructions For Use are not  followed.
If during inspection it is found that damages are due to wear and tear or are not subject to warranty, then OSKA are empowered to claim the expenses (inspection, transport costs etc) from the client.
The level of warranty for the Series1 Advance foam and cover are detailed in the table below.

| Foam| V-Guard Cover  (4 years pro-rata)
---|---|---
Year 1| 100%| 100%
Year 2| 50%| 75%
Year 3| –| 50%
Year 4| –| 25%

Technical data

Specifications/part numbers
The OSKA Series1 Advance is available in the following sizes (Width x Length x Height):

Mattress dimensions (W x L x H)| Mattress Weight (Kg)| Maximum User Weight (Kg / Stone)| Part No.
---|---|---|---
88cm x 198cm x 15cm| 12kg| 240kg / 38st| PR13-054
105cm x 198cm x 15cm| 14.5kg| 240kg / 38st| PR13-055
120cm x 198cm x 15cm| 16.6kg| 250kg / 40st| PR13-066

The materials used in the construction of the device are as follows:

| Description / specification| Technical Data
---|---|---
Mattress cover| Weft knitted polyamide, coated with antimicrobial polyurethane coating.| 235g/m2
Foam core| Combustion modified polyurethane foam (Blue)| Density: 38 – 40 Kg/m³
Hardness: 180-220N
Castellated foam surface| Combustion modified polyurethane foam (Orange)| Density: 38 – 40 Kg/m³
Hardness: 100-140N

Fire retardancy
The OSKA Series 1 Advance has a Crib 5 Fire Rating and meets BS 7177 which specifies requirements for the resistance to ignition of mattresses, divans and bed bases when tested in accordance with BS EN 597-1, BS EN 597-2 and BS 6807.

Disposal
When disposing of the Series 1 Advance it is advised that the cover is disposed of as combustible waste and the foam component is disposed of in line with local or national guidelines or regulations which may result in combustion or  landfill. The healthcare provider may also have its own policy or guidelines on disposal of foam mattresses.

Pressure Care Experts
OSKA Care Ltd
Edward House,
5 Penner Road,
Havant, PO9 1QZ UK
Series1 Advance Mattress Instructions For Use
02394 318 318
[email protected]
oska.uk.com

References

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