Harvest Healthcare BLENHEIM ACTIVE SEAT CUSHION General User/ Safety Manual Download Page 28 | Manualshive

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Harvest Healthcare BLENHEIM ACTIVE SEAT CUSHION General User/ Safety Manual Download Page 28

T +44 (0)1709 377172 F +44 (0)1709 377173

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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

Confirm on our own behalf that the Medical product: Blenheim seat cushion

complies with all applicable requirements in Appendix I of the

EU directive 93/42EEC

The following compliance evaluation process was applied:

Annex VII

EU legislation for this type of product and covers all safety, health, and environmental

requirements.

Modification of these products without consultation with Harvest Healthcare Ltd, this declaration of
conformity will lose its validity.

Director
Rotherham, 1/12/2017

DECLARARTION

OF CONFORMITY

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Summary of Contents for BLENHEIM ACTIVE SEAT CUSHION

Page 1: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 1 www harvesthealthcare co uk General User Safety Guide BLENHEIM ACTIVE SEAT CUSHION ...

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

Page 3: ...TIONS 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 TROUBLESHOOTING PARTS LIST GUARANTEES WARRANTIES DECLARATION OF CONFORMITY 4 5 6 10 6 7 7 7 8 8 9 10 10 10 11 12 15 16 17 18 19 20 21...

Page 4: ...essure range to be effective avoid placing objects on the surface that may obstruct the movement of air between the cells 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 c...

Page 5: ...on page 18 19 Suitable for continuous use Do not modify the seat cushion 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 personnel should remove the ...

Page 6: ...rator is any natural or legal person who uses the equipment or on whose instruction it is used e g nursing homes specialised retailers health insurance companies medical suppliers USER CARE PERSONNEL Users are persons who as a result of their vocational training experience or briefing are authorised to operate the equipment Furthermore the user care personnel can recognise and avoid potential dang...

Page 7: ...be read conscientiously and in detail by the user care personnel Programming of the system should be carried out by competent trained personnel Use only spares and accessories supplied or approved by Harvest Healthcare Only suitably trained personnel are allowed to operate the system 3 SAFETY INSTRUCTIONS The mains cable must be free and not be allowed to be caught up in any moving mechanisms such...

Page 8: ...operate this system This also applies for persons who only operate the system on a temporary basis 3 3 SAFETY INFORMATION FOR THE USER Ensure that the operator instructs you in the safe operation of this system In addition pay particular attention to the Warnings and Cautions page 4 5 and the general safety information as described in 3 1 If there is a suspected fault or damage unplug the mains pl...

Page 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...

Page 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...

Page 11: ...eight Maximum Patient Weight Inflated Cushion Dimensions Cushion Weight Pump Dimensions Pump Weight Operating Cycle HACBLEN001 HPU2 High Risk 5 Stone 30 kg 20 Stone 127 kg 460 x 460 x 60 mm 1 kg 270 x 90 x 140 mm 1 5 kg 10 minutes PUMP POWER REQUIREMENTS Power Rating Voltage Noise Level Fuse Medical Classification Safety Standards 1A AC220 240V 50Hz NC30 Plug Fuse 5A Type BF Applied Part EN 60601 ...

Page 12: ...T 44 0 1709 377172 F 44 0 1709 377173 12 OVERVIEW SYSTEM OVERVIEW Place the seat cushion on chiar where the patient will be seated with the cells and or vapour permeable cover up most ...

Page 13: ...E sales harvesthealthcare co uk www harvesthealthcare co uk 13 OVERVIEW Internal view of alternating cells ...

Page 14: ...tatic Mode Indicator Auto Lock Indicator Static Mode Bed Hooks PUMP OVERVIEW A B D F E C G G Power Failure The alarm will sound until the power is reinstated If the Mute botton is pressed to silence the alarm you must press the On Off switch to restart the pump When the power is reinstated check the status of the pump and ensure it is switched on Static Mode is only to be used for patient care H H...

Page 15: ...ailure will illuminate red when a fault is detected with the power supply D Alternating Static Mode Indicator When the pump is switched on for the first time it will inflate all the cells The alternating mode LED will flash to indicate that the pump is in start up mode Once all the cells have been inflated the LED will change a constant light and the alternating mode will activate The cells in the...

Page 16: ...ent will be seated with the cells and or vapour permeable cover upmost and the tubing at the front 1 Connect the seat pump to the power supply and switch on the pump At this stage main power will illuminate 2 Refer to the comfort control setting on the pump and adjust the setting to the patient s weight 3 Cover the seat cushion with a loose fitting cover if desired 4 We advise a risk assessment is...

Page 17: ...e that the patient receives sufficient support whilst achievingmaximum pressure relief and comfort Failure to follow this procedure could result in the patient being put at risk COMFORT CONTROL GUIDE Ensure that the pressure setting is set to the correct setting when the patient is using this product Refer to the pump control panel for the weight setting ...

Page 18: ...upply 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 ...

Page 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...

Page 20: ... for cracks or other damage that could be dangerous 2 Check the power cord ensure there are no bare wires 3 Check for the correct function of the low pressure light disconnect the pipes from the seat cushion into transport mode the pump should indicate low pressure within a few seconds If any faults are detected report to your distributor for replacements to facilitate repairs COMPONENTS Check air...

Page 21: ...o sanitise 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 seat cushion in accordanc...

Page 22: ...ump is connected to is working correctly 1 2 3 4 Connect the pump to the nearest working mains outlet Replace the plug fuse with the correct 5A fuse 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 te...

Page 23: ...tes 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 The CPR valve is not trapped and is in the closed position 1 2 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 the outlet on th...

Page 24: ... sequentially CHECK THAT FAULT STAGE 2 CHECK The system does not appear to be alternating Check that the static mode is not turned on 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 3 Monitor the cell for 7 minutes to see if it deflates Straighten out any kinked pipes 1 2 IF PROBLEM PERSISTS Contact Harvest Health...

Page 25: ...ted to the bed correctly Reposition the pump unit The mattress is uncomfortable Check the comfort setting on the pump Set the pump to the correct setting using the guide on the front of the pump case 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 ar...

Page 26: ...PLACEMENT PARTS PU201 PU202 PU203 PU204 PU205 Power Lead 5 metres Inlet Power Lead Label Panel Tactile Timer and Motor Front Casing HPU2 Harvest 2 Pump only PU200 Compressor PU206 Rear Casing PU207 PU208 Bed Hooks PCB PU209 Filter PU210 PU211 Fuse and Holder Connectors ...

Page 27: ...t 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 maintenance guidelines have been fo...

Page 28: ...al product Blenheim seat cushion complies with all applicable requirements in Appendix I of the EU directive 93 42EEC The following compliance evaluation process was applied Annex VII EU legislation for this type of product and covers all safety health and environmental requirements Modification of these products without consultation with Harvest Healthcare Ltd this declaration of conformity will ...

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

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

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

Page 32: ...es harvesthealthcare co uk www harvesthealthcare 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 HACBLEN001 MANUAL01 Sept 2018 ...

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