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 [email protected]      www.harvesthealthcare.co.uk

29

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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: 

PRIME COMFORT ACTIVE 

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 

Содержание AIR-TECH HHAIRT001

Страница 1: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 1 HYBRID MATTRESSES www harvesthealthcare co uk General User Safety Guide AIR TECH HYBRID MATTRESS ...

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

Страница 3: ...NTENTS WARNINGS CAUTIONS GENERAL INFORMATION TECHNICAL SPECIFICATION OVERVIEW INSTALLATION OPERATION CLEANING CARE ROUTINE MAINTENANCE TROUBLESHOOTING PARTS LIST GUARANTEES WARRANTIES DECLARATION OF CONFORMITY 4 5 6 10 11 12 13 14 15 16 17 18 19 20 21 22 25 26 27 28 ...

Страница 4: ...from sitting on the edge or on the end of the mattress whilst it is in use All hoses must be free of kinks twists and must be properly connected and positioned so as not to cause any obstruction Do not position the system in a way that prevents access to the disconnection device mains power plug Ensure the mains lead or pump cannot become trapped or crushed e g by raising or lowering of bed or bed...

Страница 5: ...nstructions can be found on page 18 19 Suitable for continuous use Do not modify the mattress or pump unit in any way Do not connect to any other medical device or equipment Not for use in an oxygen enriched environment Not for use in an outdoor environment Store the system in a clean and dry environment out of direct sunlight Electrical equipment can be hazardous Only authorised technical personn...

Страница 6: ... cells each containing a unique foam profiled insert which are in turn held within a foam U Core all protected by a vapour permeable waterproof cover The transverse cells are arranged into alternate pairs of A and B cells which are filled and emptied in sequence When used without a pump the foam mattress maintains its pressure relieving properties When the pump is connected and is in alternating m...

Страница 7: ...r infirm QUALIFIED PERSONNEL Qualified personnel are employees of the operator who as a result of their vocational training or briefing are entitled to deliver assemble disassemble and transport the product 2 NON COMPLIANT USE All uses deviating from the intended purpose which may also be hazardous as a result This includes for example Incorrect installation Operation by persons who have not been ...

Страница 8: ...ay be torn out of its strain relief and damaged or it may be pulled 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 ...

Страница 9: ...insulated The symbol for type B device according to EN 60601 1 Handle with care This way up Keep dry Recycling symbol Refers to packaging that can be recycled cardboard Fragile handle with care This product 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 No smoking No naked flames Read instructions co...

Страница 10: ...gthy break in use Any defects damage or signs of wear must be rectified without delay Only original spare parts from Harvest Healthcare may be used otherwise all guarantees or warranties will be excluded See pages 20 21 for Routine Maintenance and Servicing 3 7 SERVICE LIFE DISPOSAL Our Full Terms Conditions including product warranties are available by request or can be found on our website www h...

Страница 11: ...Minimum Patient Weight Maximum Patient Weight Inflated Mattress Dimensions Mattress Weight HHAIRT001 HPU4 Very High Risk 5 Stone 32 kg 39 Stone 247 kg 2000 x 900 x 150 mm 14 kg PUMP POWER REQUIREMENTS Power Rating Voltage Noise Level Fuse Medical Classification Safety Standards 10 Watts 220 240 Volt 50Hz Approx 25 dB A TA1H250V Type B Applied Part EN 60601 1 EN 60601 1 2 ...

Страница 12: ...mfort of a static mattress with the pressure relief of alternating cells Our foam within cells technology enables the mattress to be stepped up or down with or without a pump Harvest 4 Pump The pump has a moulded ABS case and integrated bed hooks Feed Tubes The Feed tubes are flexible durable and have excellent anti kink properties SYSTEM OVERVIEW Mattress Cover The cover comprises of a two way va...

Страница 13: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 13 OVERVIEW Feed Tube Connection Power Switch A B C D PUMP OVERVIEW B D C A Visual Low Pressure Warning Bed Hooks ...

Страница 14: ...s on to the bed base Ensure the pipes at both the head and foot ends are kink free to prevent restriction of air flow Ensure the air tubing to the pump is at the foot of the bed 2 Please ensure that the mattress is correctly sized for the bed and that the mattress is positioned using the mattress guides onto the mattress base before operating the bed 3 The pump has integral bed hooks for hanging t...

Страница 15: ...ndition this can be silenced and reset by switching the pump off and then back on again 2 LED Indicators The Blue LED indicates the pump is turned on The Red LED indicates a pressure issue in the mattress 3 CPR Valve Please ensure that the CPR connector is always placed fully home prior to inflating the mattress The mattress will NOT inflate properly should this not be the case The CPR connector i...

Страница 16: ...he mattress is being inflated When the mattress is up to the correct pressure the low pressure warning light will go off and the pump will beep The mattress is now ready to be used 1 2 DEFLATING THE MATTRESS CPR VALVE SWITCHING OFF THE SYSTEM To deflate the mattress simply disconnect the tube set from the pump If rapid deflation is required simply pull the CPR connection To turn off the system pre...

Страница 17: ...arning will be activated This may be triggered by for example a kinked Umbilical Hose or another person suddenly sitting on the mattress 2 Low Pressure Warning If the system pressure falls below 15mmHg this warning will be activated This may be triggered by for example incorrect fitting of the air inlet connector opening of the CPR Valve or a leak in the Mattress due to a cut or puncture 3 Mains F...

Страница 18: ... to the pump is disconnected before cleaning Eye protection gloves and protective clothing should be worn when carrying out cleaning and disinfection procedures When disinfecting the system Harvest 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 trans...

Страница 19: ... Haztab or bleach or combined cleaning chlorine releasing agent e g Chlorcleam Actichlor and detergent solutions are used to remove blood or other body fluids mattresses should be thoroughly rinsed with clean water to remove any residues This will help prevent any long term compatibility issues associated with disinfectant residues Alternatively disinfection may be achieved by laundering at temper...

Страница 20: ...ck the pump casing for cracks or other damage that could be dangerous 2 Check the power cord ensure there are no bare wires If any faults are detected report to your distributor for replacements to facilitate repairs COMPONENTS Check air cells and mattress interior for signs of damage or contamination e g staining or fluid ingress at each decontamination process i e between patients or patient occ...

Страница 21: ...itise reusable medical devices to prevent damage to materials and the degradation of plastic surfaces after prolonged use The use of inappropriate cleaning and detergent materials on medical equipment could damage surfaces and may compromise the ability to decontaminate medical devices adequately or may interfere with device function At end of use dispose of the pump mattress in accordance with th...

Страница 22: ...pump is connected to is working correctly 1 2 3 4 Connect the pump to the nearest working mains outlet Replace the Fuses with the correct 5A fuses Try a different device in the mains outlet 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 test...

Страница 23: ...f equipment Please record details of the results of the recommended tests Notes pages are provided at the back of this user manual PLEASE NOTE Inflation can take up to 30 minutes The hoses are routed correctly not kinked and connected to the pump correctly 1 There are no leaks in the mattress The tubes in the mattress are not disconnected or kinked 1 2 Disconnect and then re connect the hoses to t...

Страница 24: ...e inflated and deflated sequentially CHECK THAT FAULT STAGE 2 CHECK The system does not appear to be alternating Carefully mark one of the inflated cells with a pen Ensure that there are no kinks in the pipework down the side of the mattress 1 2 Monitor the cell for 7 minutes to see if it deflates Straighten out any kinked pipes 1 2 IF PROBLEM PERSISTS Contact Harvest Healthcare technical support ...

Страница 25: ...ly Reposition the pump unit 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 E sales harvesthealthcare co uk www harvesthealthcare co uk A comprehensive service manual for this system is available upon requ...

Страница 26: ... and 4 Section Castellated Foam within a Cell HHAIRT003 4 Section Castellated Foam within a Cell HHAIRT001 Air Tech Mattress only HHAIRT00F Air Tech U Co Base Foam HHAIRT002 2 Section Castellated Foam within a Cell HHAIRT001C Air Tech Top Cover and Base HPU4 Harvest 4 Pump only ...

Страница 27: ...eriod All warranties are subject to the following conditions Warranty guarantee is subject to all guidelines being adhered to That the equipment has been used for the purpose for which it was intended That the usage has been on a fair wear and tear basis This does not include user damage That Harvest Healthcare Ltd s cleaning disinfecting guidelines have been followed Harvest Healthcare Ltd s main...

Страница 28: ...hat the medical product PRIME COMFORT ACTIVE 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 DECLARAR...

Страница 29: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 29 NOTES ...

Страница 30: ...T 44 0 1709 377172 F 44 0 1709 377173 30 NOTES ...

Страница 31: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 31 NOTES ...

Страница 32: ...healthcare 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 HHAIRT001 Oct 2018 The pump is supplied by Harvest Healthcare Ltd and complies to the standard EN 60601 1 ...

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