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 +44 (0)1709 377173

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DECLARARTION

OF CONFORMITY

 

DECLARATION OF CONFORMITY

 

Declaration of Conformity Annex VII EU Directive 93/42/EEC

 

We, as company:  Harvest Healthcare Ltd

 

Sheaf House 

Bradmarsh Way 
Bradmarsh Business Park

 

Rotherham, S60 IBW

 

 

 

 

 

 

 

 

Product Development and Quality Manager

 

Rotherham, 07.04.2020

 

Confirm on our own behalf that the medical product: 

Please see the Static Mattresses list on the next page.
Risk Class: I
SRN: 

TBC

complies with all applicable requirements in Appendix I of the EU directive 93/42E EC
The following compliance evaluation process was applied:  Annex  VII
EU legislation for this type of product covers all safety,  health and environmental requirements. 

Modifying this product without consultation with Harvest Healthcare Ltd will invalidate this declaration 
of conformity.  

This declaration of conformity is issued under the sole responsibility of Harvest Healthcare.

Notified Body: TBC

This document is valid for 4 years after the date of the signature.

Authorised Representative: TBC 
SRN: TBC

Summary of Contents for COMMUNITY PLUS Series

Page 1: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 1 General User Safety Guide HARVEST STATIC MATTRESS RANGE STATIC MATTRESSES www harvesthealthcare co uk ...

Page 2: ...T 44 0 1709 377172 F 44 0 1709 377173 2 ...

Page 3: ...re co uk 3 CONTENTS WARNINGS CAUTIONS WARNINGS CAUTIONS OVERVIEW OVERVIEW GENERAL INFORMATION GENERAL INFORMATION CLEANING CARE CLEANING CARE GUARANTEES WARRANTIES GUARANTEES WARRANTIES DECLARATION OF CONFORMITY DECLARATION OF CONFORMITY 4 5 6 7 8 9 10 ...

Page 4: ... product is suitable for each individual Do not allow sharp objects to penetrate the cover material Do not use this product for whilst lifting the patient This will damage the product and could put the patient at risk Ensure that this product is used the correct way up if not reversible Do not expose this product to open flames We advise the user not smoke when using this product Facial contact wi...

Page 5: ...UNITY PLUS MATTRESS 150 190 High PRIME COMFORT PLUS 900 1200 1400 140 247 High REFLECT 2 900 1200 1370 2000 165 247 High REFLECT 2 PLUS SIZED 45 1200 1400 2000 180 285 High REFLECT 2 PLUS SIZED 60 1200 1400 2000 180 381 High KINETIC AIR 900 2000 150 247 High OVERVIEW MATTRESS RANGE OVERVIEW PERFORMANCE CHARACTERISTICS 900 1200 1400 2000 1900 900 1200 1400 MODULAR REPLACEMENT 900 160 127 Medium MOD...

Page 6: ...ts These are provided as a guide to support appropriate mattress choice but all individuals should be risk assessed by a trained professional as individual circumstances may alter mattress choices Never use a mattress with a lower risk category than that assigned to the service user by a trained professional Never exceed the maximum patient weight for a mattress Misuse of the mattress could lead t...

Page 7: ...e required The hazard of entrapment in the vertical gap between the side of the mattress and the bed rail may be exacerbated due to the soft easily compressible nature of the overlay and or mattress edge If the standard mattress is replaced with a lightweight foam mattress third party bed rail assemblies including the mattress and bed occupant can tip off the bed when the bed occupant rolls agains...

Page 8: ...Healthcare recommends the following guidelines which have been developed to comply with recognised infection control procedures These procedures are also to be used to prevent cross infection when transferring the system between patients Do not use abrasive cleaners phenol disinfectants solvents or alcohol based cleansers e g Dettol Phenicol Hibiscrub Clearsol Stericol Hycoline as these will damag...

Page 9: ... Castellated BS 7177 Crib 5 12 kg PU Welded Multizone Visco BS 7177 Crib 5 18 kg PU Welded Multizone Visco BS 7177 Crib 5 18 kg PU Welded Multizone Visco 16 kg PU Welded Multizone Castellated MATTRESS RANGE TECHNICAL SPECIFICATION COMMUNITY MATTRESS FIRE TECH 7 VANDAL PROOF FIRE TECH 7 COMFORT PRIME COMFORT COMMUNITY PLUS MATTRESS PRIME COMFORT PLUS REFLECT 2 REFLECT 2 PLUS SIZED 45 REFLECT 2 PLUS...

Page 10: ...e next page Risk Class I SRN TBC complies with all applicable requirements in Appendix I of the EU directive 93 42E EC The following compliance evaluation process was applied Annex VII EU legislation for this type of product covers all safety health and environmental requirements Modifying this product without consultation with Harvest Healthcare Ltd will invalidate this declaration of conformity ...

Page 11: ...al Proof Prime Comfort 1200mm wide Prime Comfort 1400mm wide Here is the list of the Static Mattresses HSMCOM HSMCOM 12 HSMCOMP HSMCOMP 12 HSMCOMP CAS2 14 HSMFIRET CFT HSMFIRET CFT W HSMFIRET VP HSMPRIM HSMPRIM DV12 HSMPRIM 14 HSMPRIMP HSMPRIMP 12 HFR147 HFR147 12 HFR147 1370 HFR227 HFR227 14 HFR227 60 HFR 1400 60 HK100 HFR114 HFR105 120 UDI 5060517530181 UDI 5060517532109 UDI 5060517530198 UDI 50...

Page 12: ...T REFERENCE STATICMAT MANUAL04 April 2020 ALSO AVAILABLE STATIC MATTRESS LENGTH EXTENSIONS The Static Mattress Length Extensions have been designed for use with our Static Mattress range Ideal for use with existing mattresses the piece will add a further 150mm or 200mm and close any gaps between the mattress and bed frame Once in place the kit continues to provide pressure relief around the heels ...

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