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Phase III User Manual

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1. Park House Healthcare PHASE IlI PA7900 Mattress Replacement System User Manual CONTENTS 1 Introduction 1 1 General Information 1 2 Intended Use Product Description 3 Installation 3 1 Unpacking 3 2 Setting Up 4 Operation 4 1 Function Description 4 2 Support Setting Procedure 4 3 Weight Conversions 5 Cleaning 5 1 Pump Unit 5 2 Mattress Storage Maintenance Troubleshooting ee SS Technical Description 10 Guarantees and Warranty 10 1 Pump Unit 10 2 Mattress 10 3 Guarantee 10 4 Warranty 10 5 Claims relating to Guarantee and Warranty 10 11 IMPORTANT SAFEGUARDS READ ALL INSTRUCTIONS BEFORE USING DANGER To reduce risk of electrocution ae NS Always unplug this product immediately after using Do not use while bathing Do not place or store product where it can fall or be pulled into a tub or sink Do not place in or drop into water or other liquid Do not reach for a product that has fallen into water Unplug immediately WARNING To reduce risk of burns electrocution fire or injury to persons N On 7 8 This product should never be left unattended when plugged in Close supervision is necessary when this product is used on or near children Use this product only for its intended use as described in this manual Do not use attachments not recommended by the manufacturer Never operate this product if it has a damaged cord or plug if it is
2. 44 0 1274 475046 International Email international parkhouse hc com Web www parkhouse hc com 19JULY2012 REV2
3. a 0 1 Chlorine Solution 1 000ppm and cold water If required a 1 Chlorine Solution 10 000ppm and cold water can be used Rinse thoroughly with clean water and a damp single use wipe Make sure the cover is completely dried before refitting to the mattress Frequent or prolonged exposure to higher concentration disinfectant solutions may prematurely age the fabric cover of mattresses Surfaces must be protected during use and rinsed and thoroughly dried after application of a disinfectant Laundering Before laundering mattress covers should be completely removed Where required mattress covers can be laundered as follows Pre wash 80 C 15 minutes Main wash 80 C 15 minutes This should be followed by a cold rinse and extraction Phase Ill User Manual AE Phase Ill User Manual Drying Mattress covers should be hung from a line or bar and drip dried in a clean indoor environment Covers must be completely dried before refitting to the mattress Mattress covers can be tumble dried on a low heat setting for 90 minutes Drying temperature must not exceed 40 C Exceeding this temperature can cause significant damage to the mattress cover During cleaning procedures suitable protective clothing should be worn Ensure that mains power supply to the pump has been disconnected prior to cleaning 6 Storage 1 To store the mattress lay the mattress out flat and upside down 2 Roll from the head end towards the foot end with C
4. be sure the switch is in the off position before plugging in IN NOTE The plug also serves as a disconnect device 5 Plug in and turn on the power The power switch green neon will light 6 Select the LIGHT MEDIUM or HEAVY weight setting relevant to the patient s build The light will continue to flash on the chosen setting until ready for patient use Once up to the appropriate pressure the system will then go into static mode for 10 minutes This is to enable correct positioning of the patient on a firm surface 7 After 10 minutes in static mode the system will automatically revert back to the chosen setting 8 The keypad will lock out after 6 minutes of inactivity To unlock the keypad press the LIGHT and HEAVY buttons simultaneously 4 Operation TAN NOTE Always read the operating instructions before use 4 1 Function Description 1 Static Mode If required the static button is on the front of the pump unit and once pressed the mattress will stop alternating The deflated cells will inflate to match the inflated cells and then remain static This function will last for 20 minutes and then automatically revert back to alternating mode 2 Low Pressure Alarm If the pump unit detects low pressure an intermittent alarm will sound This can be silenced by pressing the ALARM RESET button on the front of the pump 3 Mains Failure Alarm If the pump unit detects that the mains have been switched off or the power supply is
5. have been followed d That the Company s maintenance guidelines have been followed e That maintenance has been carried out by a Park House approved engineer 10 4 Warranty Extended warranties can be purchased from Park House Healthcare for more information contact Customer Services on 0845 0600 333 10 5 Claims relating to Guarantee and Warranty In the event of a fault being discovered within the warranty period the customer must notify Park House Healthcare at the earliest opportunity If upon inspection Park House Healthcare accepts liability then the equipment shall be repaired or replaced immediately If Park House Healthcare does not accept liability it shall inform the customer of its reasons for declination and provide the customer with an estimate on either the repair or replacement cost Park House Healthcare reserves the right to alter or amend this document without prior notice Phase III User Manual The Company Founded in 1984 Park House Healthcare Ltd is now recognised as a market leading supplier of specialist pressure relieving and pressure reducing equipment hospital beds and moving and handling solutions to the NHS Community and Nursing Home sectors Our innovative product portfolio encompasses a range of clinically proven healthcare solutions which are fully supported by dedicated clinical training professional product audit and complete maintenance and decontamination services Our pu
6. not working properly if it has been dropped or damaged or dropping in water return the product to a service centre for examination and repair Keep the cord away from heated surfaces Never block the air opening of this product or place it on a soft surface such as a bed or couch where their openings may be blocked Keep the air opening free of lint hair and other similar particles Never drop or insert any object into any opening or hose Connect this product to a properly grounded outlet only See grounding instructions NOTE CAUTION AND WARNING STATEMENTS NOTE Indicates some tips CAUTION Indicates correct operating or maintenance procedures in order to prevent damage to or destruction of the equipment or other property WARNING Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury SYMBOLS m Class Il IP21 4 Protected against solid foreign objects of 12 5mm and greater Protection against 3 zE Dx O gt B vertically falling water drops BF symbol indicate this product is according to the degree of protecting against electric shock for type BF equipment Attention should read the instructions Refer to instruction manual booket NOTE on ME EQUIPMENT Follow instructions for use Disposal of Electrical amp Electronic Equipment WEEE This product should be handed over to an applicable collection point for the recycling of elec
7. PR valve open AN NOTE Do not fold crease or stack the mattresses Avoid direct sunlight 7 Maintenance 1 Ensure that all hoses inside and outside the pump are kink and split free If any splits are found replace the hoses 2 Ensure that all the hoses inside and outside the pump are not brittle Replace if needed 3 Check that all indicators are working if not the faulty indicators need to be replaced by your distributor 4 Check the main power cord and plug for abrasions or excessive wear 5 Check the mattress cover for signs of wear and damage Ensure the mattress cover and hoses are connected together correctly 6 Check the air hoses for kinks or breaks 8 Troubleshooting Problem Solution Check if the mains are plugged in Check if the mains are turned on Check if the switch is on Check if any fuse in the plug has blown Reset circuit breakers on the side of the pump The pump is showing no indications it is working Check that the hoses are all connected The low pressure light is Check that the CPR is in place constantly flashing and the Check if there is any leakage in the mattress system alarm is sounding Check that all pipes are connected on the side of the mattress Disconnect hoses from pump and check if air is coming out Check that all hoses are connected securely The pump is on but not Check that the CPR is in place inflating the mattress Check that there are no kinks in the tub
8. ality should be that of atypical commercial or hospital environment dips _ SaR PST 5 Ux gt 95 dip in lt 5 Ur gt 95 dip in U for 0 5 cycle Ur for 0 5 cycle Mains power quality should be that of atypical 40 Ur 60 dip in 40 U 60 dip in commercial or hospital environment If the user of U for 5 cycles Ur for 5 cycles this device requires continued operation during 70 Urs 30 dip in 70 Ur 30 dip in power mains interruptions it is recommended that U for 25 cycles Ur for 25 cycles the device be powered from an uninterruptible lt 5 Ur gt 95 dip in lt 5 U gt 95 dip in power supply or a battery Ur for 5 sec Ur for 5 sec interruptions and voltage variations on power supply input lines IEC61000 4 1 1 Power frequency Power frequency magnetic fields should be at 50 60Hz levels characteristic of atypical location in a typical magnetic field commercial or hospital environment IEC61000 4 8 NOTE Ur is the a c mains voltage prior to the application of the test level Phase III User Manual 11 12 Phase Ill User Manual This device is intended for use in the electromagnetic environment specified below The user of this device should Recommended separation distances between portable and mobile RF communications equipment and this make sure it is used in such an environment device Immunity Test IEC60601 test Compliance Electromagnetic Environment Guidance This device is intended for use in an
9. cut then a constant alarm will sound This can be silenced by pressing the same ALARM RESET button If the system is unplugged from the power source the mattress will remain inflated for up to 24 hours if no leaks are present allowing for transportation of the patient 4 CPR Requirement If rapid deflation of the mattress is required simply pull the CPR tag When the CPR function is initiated the alarm will sound The alarm may be silenced by pressing the same ALARM RESET button Phase Ill User Manual GTA Phase III User Manual 5 Infection Control Should the mattress become infected then please refer to cleaning 6 Static transportation mode When the pump is disconnected at the mains the mattress will retain pressure in static mode for up to 24 hours You can put the mattress in to transport mode manually by disconnecting the hoses from the pump and connecting them together 4 2 Support Setting Procedure It is important to follow the correct support setting procedure to ensure the patient receives adequate support lift and maximum pressure relief and comfort 1 Select the correct patient weight setting as indicated below and press the appropriate button 2 The mattress will now inflate and the light will flash until it is ready for patient use The static mode will then engage to enable the carer to position the patient in bed and make them comfortable The static mode will automatically revert back to the selected pres
10. e level in each frequency range maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Conducted RF to 80 MHz 3 Vrms Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies IEC 61000 4 6 outside ISM Interference may occur in the vicinity of equipment marked with Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and bands the following symbol reflection from structures objects and people Radiated RF o IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fix
11. ed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Phase III User Manual 13 14 Phase Ill User Manual 10 Guarantees and Warranty 10 1 Pump Unit All new pumps have a guarantee for a period of 2 years following the date of dispatch 10 2 Mattress All new mattresses have a guarantee for a period of 2 years following the date of dispatch 10 3 Guarantee Park House Healthcare guarantees to repair or place any equipment issued to its customers which is found to be faulty during the relevant guarantee or warranty period The Company s guarantees are subject to following conditions a That the equipment has been used for the purpose for which it was intended b That the usage has been on a fair wear and tear basis c That the Company s cleaning disinfection guidelines
12. electromagnetic environment in which radiated RF disturbances are controlled ove The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum Portable and mobile RF communications equipment should be distance between portable and mobile RF communications equipment transmitters and this device as recommended used no closer to any part of this device including cables than below according to the maximum output power of the communications equipment there commended separation distance calculated from the equation applicable to the frequency of the transmitter Rated maximum Separation distance according to frequency of transmitter m Recommended separation distance output power of d 1 2 VP 150kHz to 80MHz feanemittan 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 1 2P d 2 3VP d 1 2 VP 150kHz to 80MHz d 2 34 P 80 MHz to 2 5G MHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an For transmitters rated at a maximum output power not listed above the recommended separation distance d in electromagnetic site survey should be less than the meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the 3 Vrms 150 kHz complianc
13. ing running down the side of the mattress Ensure that the patient has not been placed on the mattress before it is fully inflated The system does not appear Check that there are no kinks in the tubing running to be alternating down the side of the mattress the a k Make sure the pump is resting against a solid surface If your problem cannot be resolved using the above information please contact Park House Healthcare Phase Ill User Manual QT Phase II User Manual 9 Technical Description Product Code PA7900 Pump Specification refer to rating label on the product for 230V system Environment Temperature Operation 10 C to 40 C 50 F to 104 F Storage 15 C to 50 C 5 F to 122 F Shipping 15 C to 70 C 5 F to 158 F Humidity Operation 10 to 90 non condensing Storage 10 to 90 non condensing Shipping 10 to 90 non condensing ClassiXcation Class Il Type BF IP2I Applied Parts Air Mattress Not suitable for use in the presence of a Xammable anaesthetic mixture No AP or APG protection Continuous operation Mattress Specification Contact the distributor or EU representative for further technical documents AN NOTE The speciXcations also apply to those areas operating with the same power supply EMC Information Guidance and Manufacturer s Declaration Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below The user of thi
14. nhance healing The Phase Ill power unit is a compact pump featuring an audible and visual low pressure alarm and a manual pressure setting function The 20 cell mattress unit provides a unique design which keeps the lower levels of the cells constantly inflated whilst alternating and deflating the upper level The head section of cells remains static throughout the 10 minute alternating cycle The mattress has a heavy duty nylon base sheet with a vapour permeable P U Coated stretch cover In the event of a cardiac arrest rapid deflation is achieved by using the highly visible CPR facility 3 Installation 3 1 Unpacking The pump unit and mattress are packaged in separate boxes to secure the contents inside When unpacking the boxes to remove the pump unit and mattress check for any damage which may have occurred during shipping Please report any damages to Park House Healthcare and remove the system from use 3 2 Setting Up 1 Place the pump at the foot end of the bed 2 Remove the existing mattress and place the Phase Ill on the bed frame with the cell vapour permeable cover uppermost The inflation tubes should be at the foot of the bed AN NOTE l The Phase Ill pump must only be used with the Phase Ill mattress 3 Connect the air hoses from the mattress with the air outlet connectors on the pump unit These are quick release connectors and should click into place securely 4 Plug in the AC power cord to the AC outlet
15. rpose built state of the art Corporate Headquarters in West Yorkshire is central to our extensive network of service and logistics centres strategically located throughout the country 24 hour care 365 days a year dedicated personnel manage specific regions and divisions ensuring one on one service and support is never far away With distributors in over 25 countries Park House Healthcare Ltd is a truly international company and places important emphasis on providing tailored healthcare solutions and the highest level of customer care to our partners throughout the world Park House Healthcare Ltd is a respected member of the British Healthcare Trade Association and has BS EN ISO 9001 and EN46002 accreditation which is the speciXc quality standard for Medical Devices All products are CE marked in accordance with the European Directive 93 42 EEC teal TTAR 2 ISO9001 Certificate No 8019 IS014001 Certificate No E4681 Due to its policy of continued development and improvement Park House Healthcare Ltd reserves the right to amend any details and specifications without notice Copyright Park House Healthcare Ltd 2012 7 UM PA7900 Park House Healthcare EA Park House Healthcare Ltd Whitehall 26 Business Park 1 Heathfield Lane Birkenshaw West Yorkshire BD11 2HW UK Tel 0845 0600 333 Fax 0845 0600 334 Email sales parkhouse hc com International Tel 44 0 1274 475000 International Fax
16. s device should make sure it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance The device uses RF energy only for its internal function Therefore its RF CISPR 11 emissions are very low and are not likely to cause any interference in RF emissions nearby electronic equipment IEC61000 3 2 The device is suitable for use in all establishments including domestic Voltage fluctuations establishments and those directly connected to the public low voltage Flicker emissions Complies power supply network IEC61000 3 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC60601 test level Compliance Electromagnetic Environment Guidance Electrostatic Discharge 6kV contact 6kV contact ESD 8kV air 8kV air IEC61000 4 2 Electrical fast 2kV for power supply 2kV for power supply transient burst line line IEC61000 4 4 1kV for input out line 1kV for input out line 1 kV line s to 1 kV line s to Surge line s line s Mains power quality should be that of atypical IEC61000 4 5 2 kV line s to earth commercial or hospital environment Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power qu
17. sure setting after 10 minutes 4 3 Weight Conversions 5 Cleaning The following guidelines are suggested by Park House Healthcare Ltd as being suitable infection control procedures Further information is available upon request 5 1 Pump Unit It is important to follow the cleaning procedures for single patient use General cleaning may be affected by using a cloth dampened with a mild detergent and water solution This approach may be followed either by wiping with a sodium hypochlorite solution to a dilution of 1000 ppm or by using an alcoholic wipe Wipe the pump unit with a damp cloth and a mild detergent and keep it away from dust If another detergent is used choose one that will have no chemical effects on the surface of the plastic case of the pump unit AN CAUTION l Do not immerse or soak pump unit Do not use hyper carbonate or phenol based cleaning solutions Do not use any abrasive compounds or cleaning pads 5 2 Mattress General Cleaning Using a single use wipe clean the mattress cover with a solution of neutral detergent and hand hot water Rinse thoroughly with clean water and a damp single use wipe NOTE The top bottom and all four sides of the mattress including under the zip flaps MUST be cleaned Disinfecting the cover If the cover is heavily soiled or has been exposed to bodily fluids such as blood it will require a more thorough cleaning procedure Wipe the cover using a single use wipe and
18. trical and electronic equipment For more detailed information about the recycling of this product please contact your local city office household waste disposal service or the retail store where you purchased this product Manufacturer Authorised representative in the European community SAVE THIS MANUAL FOR REFERENCE 1 Introduction This manual should be used for initial setup of the system and for reference purposes 1 1 General Information The Phase IIl System is a high quality mattress replacement system suitable for the treatment and prevention of pressure ulcers The Phase Ill System has been independently tested and successfully approved to the following standards N 60601 1 N 60601 1 2 N 55011 Class B N 61000 3 2 Class A N 61000 3 3 N 61000 4 2 N 61000 4 3 N 61000 4 4 N 61000 4 5 N 61000 4 6 N 61000 4 8 N 61000 4 11 1 2 Intended Use This product is intended to reduce the incidence of pressure ulcers whilst optimising patient comfort AN NOTE Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide Phase III User Manual 2 Product Description The Phase Ill is an alternating mattress replacement system used in the prevention and treatment of pressure ulcers By using the established principles of alternating therapy the Phase IIl offers patients a comfortable and relaxing support surface which can both prevent skin breakdown and e

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