Multipulse™ 500 Compression Therapy System User Manual
Contents
1. Press to load session and return to menu Press o to return to initial MENU screen Press to start treatment session IMPORTANT Itis necessary to scroll back to initial MENU screen using O before pressing to start the treatment session NB The selection process may be ended at any time by pressing the MUTE button to return to the menu level without updating the setting 112. Thank you for choosing to use the MULTIPULSE 500 compression therapy system The MULTIPULSE 500 system comprises five chamber pneumatic leg or arm garments for the non invasive treatment of lymphoedema venous insufficiency and some chronic non healing wounds and ulcers The garment chambers inflate sequentially from the foot hand to give gradient compression to the limb The MULTIPULSE 500 represents the pinnacle of technology in external pneumatic compression therapy Features include Adjustable pressure ranges 30 120mmHg Adjustable cycle times 6 to 80 seconds per chamber 3 distinct programmable therapy periods 10 120 mins per session Fixed or adjustable gradiency Saves up to 9 individual treatment sessions The MULTIPULSE 500 compression therapy system will benefit from careful installation and use providing a long and effective service life Please read this user manual in order to achieve the best possible results Talley Medical products are manufactured to comply with BSI IEC UL and other European safety standards Talley Medical design and manufacture products to conform to the requirements of ISO9001 ISO013485 and Directive 93 42 EEC Talley Medical reserves the right to modify the specification of any product without prior notice in line with a policy of continual product development Our standard terms and conditions apply Specification Pump Unit Model Reference MULTIPULSE 500 TM
3. the power unit will stop and display GARMENT PLUG ERROR If disconnection was accidental current therapy may be resumed with remaining therapy If a particular setting is seen to blink this is because the cycle time is too low for the pressure selection or garment type in use Loading Therapy Settings If therapy settings have previously been selected and saved these can be loaded as follows Switch power unit on wait for initial MENU screen display Press to scroll to SAVE LOAD Press to select Press to scroll down to Load Settings and select required treatment session setting number Press to load setting and return to menu Press o to return to initial MENU screen Press to start treatment session Therapy settings are selected as follows THERAPY PRESSURE CYCLE TIME If required If required If required Press Press Press Press Press Press Press Press Press Press Press Press Press Press Press O es OE Oo O OW Q oa to scroll to THERAPY to select a 4 to select therapy time to select T2 T3 and set as above to save and return to menu to scroll to PRESSURE to select amp o to select pressure setting to select T2 T3 and set as above to save and return to menu to scroll to CYCLE TIME to select e to select cycle time to select T2 T3 and set as above to save and return to menu 10 GRADIENT If requi
4. and the surrounding environment to provide prolonged microbial protection for up to 4 weeks after application 15 time by pressing START STOP after reconnection However if connecting a different garment type than previous return to initial MENU screen press down then up arrow buttons and press START STOP to commence therapy period with current therapy settings Data Information To enter this mode scroll down from initial MENU screen using arrow button When Data Information is displayed press DATA button to select Using arrow buttons scroll to view the following information Fault Log Entries 1 5 Software ID Boot Loader Hours Run Hours to Service Hire Time Product Code Serial No Last Service Date Owner Contact Name Telephone Hospital Ward Patient Ref A range of test and service modes are available for access by trained personnel Information is available from Talley Medical on request 9 Ifa timed treatment session has been selected an alarm will sound and DISCONNECT GARMENT will be displayed on screen when treatment session is complete press MUTE to silence alarm To disconnect garment hoses squeeze both sides of garment plug and remove from socket 10 Place user manual in a safe place for future use IMPORTANT Switching The Unit Off On switching the unit power off the mains fail alarm will operate automatically indicated by AC FAIL on the display Simply press the MUTE butt
5. 001 Manufacturers declaration Electromagnetic Emissions Model Type 9b is intended for use in the electromagnetic environment specified below The customer or user of the Type 9b systems should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF emissions Harmonics emissions Voltage Fluctuations Flicker emissions 61000 3 3 N A The Type 9b systems are suitable for use in all other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Manufacturers declaration Electromagnetic Immunity The Tye 9b systems are intended for use in the electromagnetic environment specified below The customer or user of the Type 9b system should assure that it is used in such an environment x Electromagnetic environment Compliance level guidance Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC61000 4 8 IEC 60601 Test Level 6kV contact 8KV air 2 Kv For power supply lines 1kV For input output lines 1kV line s to line lt 5 Ur gt 95 Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70
6. 300 4 Width 325mm 12 8 Height 233mm 9 2 Depth 165mm 6 5 Weight 3 4kg 7 5lbs Construction ABS Plastic Power Cord 5 metres 16 Cycle Time 30 to 400 seconds Cell Inflation Time 12 to 160 seconds 2 5 of cycle time Cell Deflation Time 18 to 240 seconds 3 5 of cycle time Power Supply Europe 230V 10 50Hz USA 110V 10 60Hz Power Consumption 8W Fuse Rating 500 mA Electronics Control Type 9 Pressure Range 30 120mmHg leg with automatic extension of up to 10 seconds per cell if required pressure is not reached in nominal inflation time Garments Material PU coated Nylon Closure Method Zipper velcro on garments with expander panel Type Five chamber garments List of Components Your MULTIPULSE 500 compression therapy system consists of these items please ensure you have all necessary components before application MULTIPULSE 500 power unit with display Compression garment s Full leg m I xI Calf one size Arm s m Forearm one size medium large and extra large full leg garments are available with an attached expander panel for use when a larger garment is required Cautions and Warnings Only use this device on the recommendation of a licensed physician Before using this product ensure that the electricity supply is of the type indicated on the power unit the mains lead is free from damage and is positioned so as not to cause a
7. EXPLANATION OF LABEL SYMBOLS AND STATEMENTS ATTENTION Consult accompanying documents Medical Devices Directive 93 42 EEC Electrical Protection Type B Class II Equipment Double Insulated This is a functional earth and not a protective earth Do not dispose of with the normal household waste F Gl gt a gt This is a statement that alerts the user to the WARNING possibility of serious injury or other adverse reactions with the use or misuse of the device This is a statement that alerts the user to the CAUTION possibility of a problem with the system associated with its use or misuse oll This product is CLASSIFIED by Underwriters Laboratories Inc with respect to electric shock fire c US and mechanical hazards only in accordance with 1BD1 UL60601 1 and CAN CSA C22 2 No 601 1 U S PATENT PENDING USER MANUAL PART NUMBER 50 02 05 100 6 www talleygroup com Aan SGS UKAS TALLEY GROUP LIMITED Premier Way Abbey Park Ind Est Romsey Hants S051 9DQ England Na cad Europe re order 0 1794 503500 l ALLE Y TALLEY MEDICAL USA PMD C 1070 E Wieland Road Lansing MI 48906 USA Trades G R O U P USA re order Talley USA 888 259 9994 Association 0120 02 2012 TALLEY MEDIC AL Multipulse 500 Compression Therapy System User Manual Notes 20 Guidance and Manufacturer s Declaration on Electromagnetic Immunity and Emissions Class A industrial 55
8. Ur 30 dip in Ur for 25 cycles gt 5 Ur gt 95 dip in Ur for 5 seconds 3 A m 6kV contact 8Kv air 2 Kv For power supply lines 1kV For input output lines 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 quality should be that of a typical commercial hospital environment 1kV line s to line Mains power quality should be that of a typical commercial hospital environment lt 5 Ur gt 95 Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles gt 5 Ur gt 95 dip in Ur for 5 seconds 3 A m Mains power quality should be that of a typical commercial hospital environment If the user of the Type 9b system requires continued operation during power mains interruptions it is recommended that the Type 9b be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Contents INTRODUCTION LIST OF COMPONENTS CAUTIONS AND WARNINGS INFORMATION GARMENT APPLICATION AND SYSTEM SET UP THERAPY SETTINGS USER GUIDELINES CARE AND MAINTENANCE FAULT FINDING SPECIFICATION GUIDANCE AND MANUFACTURER S DECLARATION ON ELECTROMAGNETIC IMMUNITY AND EMISSIONS Page co oO A W DN 20 Introduction
9. ments will withstand the thermal disinfection washing procedures described in the Department of Health Circular HSG 95 18 For day to day cleaning purposes it is suggested that garments are cleaned using hot water and soap or neutral detergent or chlorine releasing agents at a concentration of 1000 ppm Do not use bleach chlorine releasing agents in concentrations over 1000 ppm solvents or alcohol based cleansers e g Phenicol Hibiscrub Clearsol Stericol Hycoline as these will destroy the material Do not Autoclave Do not immerse the garments in water unless air tubes and rapid deflation device are sealed as fluid may enter the air chambers and tubing Power Unit Always disconnect the power unit from the electrical supply before cleaning The power unit can be wiped down with a damp cloth or alcohol wipe Do not use solvents The unit contains no user serviceable parts and should only be serviced by a competent electrical technician or returned to Talley Medical or your local authorised dealer All Talley Medical products should be serviced regularly by Talley Medical or authorised dealer in order to comply with warranty conditions NB Before returning equipment to Talley Medical for service be sure that it has been properly cleaned and disinfected in accordance with local health service guidelines Talley Medical recommend the use of TECare sanitising products for the cleaning and decontamination of patient care equipment
10. n obstruction the system is not used in the presence of flammable anaesthetics For 110V units only means to isolate the power unit from the electricity supply shall be carried out via disconnecting the plug attached to the non detachable mains cord from the wall socket Do not place garments or power unit on or near a heat source Do not use with hot water bottles or electric blankets Although the materials used in the manufacture of all components of the MULTIPULSE 500 compression therapy system comply to the latest fire safety regulations Talley Medical advises against smoking while the system is in use to prevent the accidental secondary ignition of associated items which may be flammable The equipment conforms to IEC 60601 1 2 for electromagnetic interference however should the equipment be subjected to electromagnetic interference outside this standard then the unit should be reset Contraindications The use of external compression may not be recommended in the following conditions 1 Known or suspected deep vein thrombosis 2 Congestive heart failure pulmonary oedema 3 Active infections 4 Local conditions e g dermatitis skin graft The MULTIPULSE 500 power unit will also notify you of the following problems if they occur Service due Contact Talley Medical to arrange service Kinked tube Check tubing for kinks or obstruction No garment Connect required garment s Invalid garment Select c
11. o allow for inflation when in operation 6 Connect garment hose s to outlet s on side of pump a Push garment hose plug into either socket until it clicks into place with 2 clicks TO ENSURE PLUG IS PROPERLY CONNECTED IT IS ESSENTIAL THAT 2 CLICKS ARE HEARD CONFIRMING BOTH SIDES OF THE CONNECTOR ARE IN PLACE b Repeat for second garment if using 7 Switch power on at the left hand side of the power unit The unit will initialise with Please Wait on the display When initialised the power unit will display the initial MENU screen Fig 1 Indicates menu setting to be editted Use arrow keys to scroll through settings Fig 1 MEN T LEGS B NONE T1 Indicates garment type and Refers to therapy size connected to top and period up to 3 bottom power unit sockets periods per session 8 Therapy settings can now be loaded or new settings programmed please see Therapy Settings section Press START STOP to activate operation of the power unit Last used treatment session will operate if no other session is recalled When in operation the screen displays selected settings and current operation status Fig 2 Therapy time Cycle time in Gradient Current set cell pressure remaining in seconds flashes until set pressure minutes is achieved Fig 2 29m 200s 3 38 MP500 T1 Power unit Therapy period model no no Care and Maintenance Garments Always keep the garments as clean as is practicable The gar
12. ods using the THERAPY SKIP button If T2 is set to O minutes cycle time only T1 will operate If T3 is set to O minutes then only T1 and T2 if set will operate User Guidelines Only use this device on the recommendation of a licensed physician Contraindications The use of external compression may not be recommended in the following conditions a b c d Known or suspected deep vein thrombosis Congestive heart failure pulmonary oedema Active infections Local conditions e g dermatitis skin graft YS mH we NS The digital display on the front of the power unit will display all errors faults warnings and relevant unit information All air tubing must be free of kinks twists and be properly connected ensure garment type is displayed on initial MENU screen to confirm correct connection Compression should be terminated and garments removed if patient experiences pain tingling or numbness If power unit should cease operation during treatment and air becomes trapped in the leg garment air can be quickly released by disconnecting garment plug from power unit If the power unit is stopped prior to the end of the therapy period the power unit will continue with the remaining therapy time when restarted However the remaining time may be cleared by pressing MUTE at the initial MENU screen or by editing the therapy time for a new value If a garment is connected or disconnected whilst the power unit is operating
13. on to silence the alarm Therapy Settings The MULTIPULSE 500 power unit allows the setting up of up to 9 treatment sessions each comprising up to 3 therapy periods Each therapy period T1 T2 and T3 has its own variable duration pressure cycle time and gradient settings Setting ranges are as follows these may be limited by garment type connected Therapy 10 to 120 minutes or continuous in 10 minute increments Continuous period will continue indefinately until START STOP is pressed or power removed Pressure 30mmHg to 120mmHg in 5mmHg increments Cycle Time 30 to 400 seconds in 10 second increments Automatic extension of up to 10 seconds per cell if required pressure is not reached in nominal inflation time Gradient 1 5 displayed as 1 3 or 6 or individually set pressures ISP may be selected The set pressure is reduced by the selected gradient level for each successive chamber after the first foot section In ISP mode each chamber may be set to any value to maintain a negative gradient Selecting Therapy Settings Before selecting any settings initial MENU screen Fig 1 must be displayed If unit is already in operation press STOP START If more than one therapy period is required within a treatment session settings must be selected in parallel across each required therapy period e g therapy time for T2 T3 must be selected before moving on to pressure settings Toggle between therapy peri
14. orrect garments for use with the MULTIPULSE 500 power unit Uncalibrated Contact Talley Medical for recalibration Fault Finding The MULTIPULSE 500 power unit has several alarm systems to warn of possible malfunction All alarms can be silenced and reset by pressing the MUTE button The MULTIPULSE 500 power unit has a Fault Log that records the last 5 faults via the Date Information display mode see page 14 AC Fail indicates a mains power failure A continuous alarm will sound if power is interrupted e g pump switched off power cut disconnection of mains lead Press MUTE or re connect to power supply Rotor System indicates automatic sequential cycle has stopped or there is a fault in the system Switch power off press MUTE button then switch power on again If fault re occurs contact Talley Medical Low Pressure will alert if pressure falls below minimum allowable levels Press MUTE button to clear alarm Check hose connections and inspect garment for leaks To ensure garment hose plug is properly connected to the pump it is essential that 2 clicks are heard confirming both sides of the connector are in place refer to initial MENU to check display indicates correct garment connection Check that rapid deflation device on leg garment is fully closed Note that alarm will reoccur if fault persists If problem reoccurs contact Talley Medical NB Also confirm that Please Wait is displayed during initialisa
15. red Press to scroll to GRADIENT Press to select Press amp G4 to select gradient setting Press Press to save and return to menu to select T2 T3 and set as above If ISP gradient is selected the individual cell pressures can be set as follows These settings are global for all therapy periods within a treatment session If 1 5 3 or 6 gradient is selected the individual cell pressure settings are overridden CELL 1 to CELL 5 settings can also be used to allow the individual chamber to be skipped during the compression cycle to avoid compression over painful areas If a cell is set to skip it will be given a value of OmmHg and will therefore not inflate The settings for skipped cells are global for all therapy periods within a treatment session CELL 1 If skip required or to set cell pressure CELL2 5 Press to scroll to CELL 1 Press to set cell to skip Press to select CELL 1 Press amp H to select cell pressure Press to save and return to menu As above pressing to scroll to each cell SAVE LOAD Press to scroll to SAVE LOAD Press to select Press amp o to select Save Settings and select setting number against which to save treatment session 1 9 Press to save and return to menu To load treatment session at this point press again to re select SAVE LOAD menu Press to scroll down to Load Settings and select required treatment session
16. tion and not Uncalibrated or Service Due If either of these statements are displayed contact Talley Medical EMI indicates that the unit detects the pressure sensor amplifier is adversely affected by external RF fields This will clear when interference ceases OTHER ALARMS There is a PUMP OR TRIAC fault that indicates a triac failure or an open pump coil fault Should this or any other fault display occur contact Talley Medical Garment Application and System Set Up 1 Remove garments from packaging Check that the garments are not damaged 2 Check that the mains lead on the power unit is not damaged 3 Adjust the hanging brackets following instructions shown on back of power unit to enable the power unit to be hung from the footboard of a bed The power unit may also be placed on the floor or table top 4 Plug mains lead into power outlet Ensure that the mains lead is positioned so as not to cause an obstruction 5 Fit garment s to patient according to the following instructions a Unfold and unzip garment and place under limb If using garment with attached expander panel unfasten zipper fully to release panel Be sure that the side with the air tubing attached is on the outside and tubing is not trapped between the garment and the skin b Fasten garment zip or secure with velcro if using garment with expander panel ensuring tubing is not trapped NB Garment will be loose fitting at this stage t
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