Harvest Healthcare Duke Extra 1200 HRD430C General User And Safety Manual Download Page 19

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+44 (0)1709 377172

+44 (0)1709 377173

[email protected]

www.harvesthealthcare.co.uk

DECLARARTION

OF CONFORMITY

We, as company:

Declaration of Conformity

Annex VII

EU Directive 93/42/EEC

Harvest Healthcare Limited

Sheaf House

Bradmarsh Way

Bradmarsh Business Park

Rotherham, S60 1 BW

Confirm on our own behalf that the medical product:

DUKE EXTRA ACTIVE

MATTRESS SYSTEM

Complies with all applicable requirements in Appendix I of the EU directive 93/42/EEC.

The following compliance evaluation process was applied:

Annex VII

In the event of modification of this product without consultation with the manufacturer,

this declaration of conformity will lose its validity.

Rotherham,

01.12.2015

Director

DECLARARTION

OF CONFORMITY

Summary of Contents for Duke Extra 1200 HRD430C

Page 1: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 1 General User Safety Guide DUKE DUKE EXTRA REPLACEMENT SYSTEM ACTIVE MATTRESSES www harvesthealthcare co uk ...

Page 2: ...NSTRUCTIONS 3 2 SAFETY INFORMATION FOR THE OPERATOR 3 3 SAFETY INFORMATION FOR THE USER 3 4 SYMBOLS USED 3 5 CLEANING DISINFECTION 3 6 SERVICING MAINTENANCE 3 7 SERVICE LIFE DISPOSAL TECHNICAL SPECIFICATION OVERVIEW INSTALLATION OPERATION CLEANING CARE ROUTINE MAINTENANCE PARTS LIST TROUBLESHOOTING EMC STATEMENT GUARANTEES WARRANTIES DECLARATION OF CONFORMITY 4 5 6 10 7 7 7 7 8 8 9 10 10 10 11 12 ...

Page 3: ...e electricity supply is of the type stated on the pump unit Protect your system from open flames Ensure that the system is not used in the presence of flammable anaesthetics Do not place device on or near a heat source or cover pump with bedding Harvest Healthcare advise against smoking whilst the system is in use to prevent the accidental ignition of associated items which may be flammable such a...

Page 4: ...e used on a profiling bed GENERAL INFORMATION Read through this instruction manual conscientiously from start to finish Please note that the various safety instructions must be observed BEFORE USING THIS SYSTEM FOR THE FIRST TIME Harvest Healthcare products bear the CE mark and meet all safety and functionality requirements These safety requirements can only be met if the user is satisfied with th...

Page 5: ...led out of its socket and electric leads exposed as a result If the mains cable or the mains plug are damaged the relevant part must be replaced This work should be carried out by the manufacturer or authorised service agents When connecting the mains plug do not use multiple sockets since liquids may penetrate into these fire hazard and electric shock 3 2 SAFETY INFORMATION FOR THE OPERATOR With ...

Page 6: ...O FURTHER DEVELOPMENT AND THEREFORE DEVIATE FROM THE DETAILS GIVEN The system must not be disposed of as normal domestic waste after its service life but must be disposed of in a designated refuse bin for waste electronic devices WEEE in the European Union Do not dispose of as normal domestic waste TECHNICAL SPECIFICATION DUKE TECHNICAL SPECIFICATION Product Code Pressure Sore Risk Level Minimum P...

Page 7: ...es are flexible durable and have excellent anti kink properties SYSTEM OVERVIEW OVERVIEW DUKE EXTRA OVERVIEW CPR Valve The mattress can be rapidly deflated through the use of the CPR valve allowing emergency personnel to begin resuscitation Duke Cells The Duke Extra has 27 independent cells which can be individually removed and replaced to allow for cost effective repair and in depth cleaning Feed...

Page 8: ...p objects which may puncture the cover or air cells Carefully unroll the mattress on to the mattress platform Ensure that the pipes at both the head and foot ends are kink free and straight to prevent restriction of air flow Ensure that the air tubing to the pump is at the foot of the bed 2 The straps on the under side of the mattress are used to secure the mattress to the bed Secure the straps us...

Page 9: ...xtra system will be delivered to you in a box This prevents the foam surround from damage during trasportation In addition any attempt to roll or fold the mattress may result in damage to the foam surround The Duke Extra mattress does not include securing straps Please ensure that the mattress is correctly sized for the bed and that the mattress is positioned onto the mattress base using the mattr...

Page 10: ...TRESS Switch on The pump will automatically begin to inflate and start a 30 minute mattress inflation mode until the correct pressure is reached During this stage select a weight setting to suit the service user Low Medium or High The weight setting is selected by pressing the Function button 1 2 Set the pump to run at the correct pressure to suit the weight of the service user Refer to the Comfor...

Page 11: ...aining or body fluids on the mattress cells or tubing wash thoroughly with soap and water then wipe with a sodium hypochlorite solution diluted to 1000ppm before laundering Mattress covers may be laundered as follows 1 Pre wash Cold 10 minutes 2 Main Wash 80 C 10 minutes 3 Followed by cold rinses and extraction WARNING Ensure that the mains power supply to the pump is disconnected before cleaning ...

Page 12: ...ortation of the mattress system The mattress should be loosely rolled lengthwise with the cover innermost taking care not to strain the feed pipes It can then be stored transported in the carry bag with the pump mains cable and this booklet Do not stack bagged mattresses more than two high ROUTINE MAINTENANCE MATTRESS The mattress cover which is made from waterproof and vapour permeable material s...

Page 13: ...dequately or may interfere with device function At end of use dispose of the pump mattress in accordance with the local regulations including WEEE requirements which apply to the pump and SMPS only Failure to follow the Duke service schedule may invalidate future warranty claims Gurantees Warranties can be found on page 35 PARTS LIST APPLIED PARTS HD443 HR446 Duke Top Cover and Base Duke Inner Com...

Page 14: ... co uk www harvesthealthcare co uk 27 CHECK THAT FAULT STAGE 2 CHECK The Pump appears to be running but the mattress is not inflating correctly and or the low pressure light is illuminated IF PROBLEM PERSISTS Contact Harvest Healthcare technical support Before calling Please ensure you have the serial number and model of equipment Please record details of the results of the recommended tests Notes...

Page 15: ...on until the static light goes out and set the pressure control to the appropriate setting for the person on the mattress 1 2 3 IF PROBLEM PERSISTS Contact Harvest Healthcare technical support Before calling Please ensure you have the serial number and model of equipment Please record details of the results of the recommended tests Notes pages are provided at the back of this user manual T 44 0 17...

Page 16: ...ipment is necessary the Duke and the other equipment should be observed monitored to verify normal operation in the configuration in which it will be used For the purposes of EN60601 1 2 the Duke has an essential performance the Duke must maintain required pressure within a tolerance of 10 1 The use of accessories transducers and cables other than those specified with the exception of transducers ...

Page 17: ...t level EMC STATEMENT IEC 60601 TEST LEVEL IMMUNITY TEST COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Conducted RF IEC61000 4 6 Radiated RF IEC61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3V m Portable and mobile RF communications equipment should be used no closer to any part of the Duke including any cables than the recommended separation distance calculated from th...

Page 18: ...vest Healthcare Ltd Mattress are covered by warranty for a period of 12 months from date of purchase Damage through incorrect use and penetration by sharp instruments will invalidate this warranty PUMP The Duke Pump is covered by warranty for a period of 3 years from the date of purchase This excludes all serviceable parts such as the bellows and filters which are recommended to be changed every 1...

Page 19: ... Business Park Rotherham S60 1BW Confirm on our own behalf that the medical product DUKE EXTRA ACTIVE MATTRESS SYSTEM Complies with all applicable requirements in Appendix I of the EU directive 93 42 EEC The following compliance evaluation process was applied Annex VII In the event of modification of this product without consultation with the manufacturer this declaration of conformity will lose i...

Page 20: ...T 44 0 1709 377172 F 44 0 1709 377173 E sales harvesthealthcare co uk www harvesthealthcare co uk 38 39 NOTES NOTES ...

Page 21: ...althcare co uk Copyright Harvest Healthcare Harvest Healthcare Limited Company No 07210261 Our Full Terms Conditions are available by request or can be found on our Website Harvest Healthcare reserves the right to alter or amend this document without notice Serial No DOCUMENT REFERENCE HR440 MANUAL01 June 2016 The Duke pump supplied by Harvest Healthcare Ltd complies to the standard EN 60601 1 ...

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