Belmont Medical Technologies Hyperthermia Pump 505 Manual Download Page 1

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Hyperthermia Pump™

OPERATIONAL CHECK OUT MANUAL

780 BOSTON ROAD
BILLERICA, MA 01821, USA

T: 866.663.0212
F: 978.663.0214

TECHNICAL SUPPORT

USA: 855.397.4547
WORLDWIDE: +1.978.663.0212

[email protected]

WWW.BELMONTMEDTECH.COM

Summary of Contents for Hyperthermia Pump 505

Page 1: ...ump OPERATIONAL CHECK OUT MANUAL 780 BOSTON ROAD BILLERICA MA 01821 USA T 866 663 0212 F 978 663 0214 TECHNICAL SUPPORT USA 855 397 4547 WORLDWIDE 1 978 663 0212 TECHSUPPORT BELMONTMEDTECH COM WWW BELMONTMEDTECH COM ...

Page 2: ... MA 01821 USA Emergo Europe BV Prinsessegracht 20 2514 AP The Hague The Netherlands 31 0 70 345 8570 All service calls questions should be directed to USA 855 397 4547 Worldwide 1 978 663 0212 CAUTION Federal law USA restricts this device to be sold by or on the order of a physician REF 702 00134 Rev I ...

Page 3: ...vice and Preventive Maintenance Schedule 6 Schedule 1 6 Schedule 2 6 C Routine Maintenance 7 1 Clean and or Disinfect Exterior 7 2 Fluid Out and In Line Air Detectors 7 3 Power Cord 7 4 Temperature Probes 7 5 Fan Guards 7 6 Vacuum Trap 7 7 Seals 8 8 Instrument Door and Ceramic Disks 8 9 Rubber Feet 8 D Testing the System and Operational Check Out 9 1 Visual Inspection 9 2 System Operational Checko...

Page 4: ...dic maintenance at least once a year and parameters setting The instrument does not need regular calibration WARNING Practice standard precautions when handling any caustic solution Clean up all spills immediately WARNING Test leakage current routinely to insure against electrical shock hazard CAUTION Turn the system to STANDBY and unplug the power cord before cleaning to avoid electric shock CAUT...

Page 5: ...00 to 300 mmHg Parameter Setup changes is performed in the Service mode www belmontMedTech com Pressing the SERVICE key accesses the Calibration Set up mode This key appears on the BELMONT logo screen only at system powered up This screen remains active for 4 5 seconds before the system enters the Prime mode For Hyperthermia Treatment Only Not for infusion into the circulatory System AGREE DIS AGR...

Page 6: ...E key A numerical keypad will be displayed Enter the appropriate time or date information Enter the appropriate time in 24 hour clock format i e 1 00 PM 13 00 CANCEL will erase the entered value and return to the previous Date Time screen Press UPDATE to save the new value and return to the previous DATE TIME key screen Press NEXT to return to the Calibration Set Up screen Screen after pressing DA...

Page 7: ...ime for a key to respond The MEDIUM setting requires more time and the SLOW key requires the most time and makes the touch keys least sensitive The key sensitivity is set at factory to Fast Note that this key changes the time required to depress a key for stroke to be recognized The pressure required is not affected 5 Pressure Limit The user can set the maximum allowable in line pressure The possi...

Page 8: ... Fluid Out and In Line Air Detector 3 Check the Power Cord 4 Clean Temperature Probes 5 Check Clean the Fan Guard 6 Check Clean the Vacuum Trap 7 Check the System Seal 8 Check Instrument Door and Ceramic Disk 9 Check Rubber Feet Schedule 2 To be performed by either a BMET or other qualified service personnel Required Test Verification Interval Every 6 Months Every Year 1 Perform Visual Inspection ...

Page 9: ...f they become dirty or wet clean with a moistened Q tip and dry Air detector surfaces are delicate Use care when carrying out this procedure 3 Power Cord Inspect the power cord along its length and connectors for cuts and breaks Replace power cord if damaged 4 Temperature Probes Keep the probe sensors clean and dry If they become dirty or wet clean with a moistened Q tip and dry Use care not to da...

Page 10: ...te correctly The platen part of the roller pump is located on the door The platen must line up properly with the pump a Check hinges for debris build up clean any dried debris fluid from hinges area Be sure that door is seated completely down on the hinges b Check plastic rivets and door integrity Make sure that the door frame is not bent Replace if bent c Inspect the ceramic disks on the door and...

Page 11: ...etectors are clean ii Check that all the plastic push pins on the door are in place iii Check that the valve pincher set screw is tight iv Check that there are no cracks in the ferrite on either the door or the right hand side v Check that the pressure transducer diaphragm has no tears or rips vi Check that each pump roller spins freely If not remove and clean vii Check that the door is pushed all...

Page 12: ...s free of air bubbles f Press PERFUSE to start pumping at 10 ml min Press RATE to change flow rate g Remove the power cord Verify that the system automatically switches to battery when AC is disconnected BATTERY NO HEATING message displays to indicate the system is now in battery mode and heating is suspended Verify that alarm sounds every 10 seconds Press MUTE and STOP h Connect back to AC power ...

Page 13: ...jack and attach large clamp to equipotential ground terminal on the Hyperthermia Pump iii Record the leakage current displayed for each of the following conditions with Neutral switch in NORM position Tests should be performed in the following order Polarity NORM Ground NORM Polarity REVERSE Ground NORM Polarity REVERSE Ground OPEN Polarity NORM Ground OPEN iv Repeat the first two Normal Polarity ...

Page 14: ...iii Prime the Hyperthermia Pump with saline Make sure that the entire patient line including the cannula has been primed iv Repeat a iii and a iv with the Hyperthermia Pump in the STANDBY ON and pumping at 750 ml min modes v Maximum leakage allowable is as follows With NORMAL NEUTRAL Normal Polarity Grounded 10 µA Reverse Polarity Grounded 10 µA Reverse Polarity Not Grounded 50 µA Normal Polarity ...

Page 15: ...ss the SERVICE screen to insure that this mode is not accessed accidentally Press the SERVICE key at power up to access the Calibration Set up screen This screen remains active for 4 5 seconds before the system enters the Prime mode screen WARNING Do not access hardware verification while the instrument is patient connected Press HARDWARE from the Calibration Set Up screen Enter the Password 01319...

Page 16: ...es Pressure Pressure in mmHg Fluid Out Detector Status Air or Fluid Air Detector Status Air or Fluid Battery Voltage Battery charge level in volts Board Temperature Temperature of the circuit board inside the case Function Key Action PUMP SPEED Change pump speed LEFT VALVE Move the valve to the left or recirculate position OPEN VALVE Move the valve to the middle or load position RIGHT VALVE Move t...

Page 17: ...to the wall outlet d Flow Rate The flow rate can be verified by actually measuring the flow using a graduated cylinder and timer or by using a tachometer Choose the method that best serves your setup Directly measure the flow i Make certain the patient line and entire disposable is fully primed before measuring Set the pump speed to 10 ml min Press RIGHT VALVE to set the valve into the infuse posi...

Page 18: ...t the fluid supply to the disposable Remove the patient line from the luer connector Insert the thermocouple approximately 2 into the connector previously connected to the patient line ii Press the RIGHT VALVE key to set the valve to the infuse position Open the fluid supply and set the pump speed to 500 ml min iii Let the temperature stabilize wait at least 2 minutes The INPUT TEMPERATURE and OUT...

Page 19: ... installed see Chapter 2 Installing the Disposable and the flow path is not blocked iii Make certain the fluid is warm 37 42 C The pressure chamber of the disposable is less compliant when it is at room temperature Verification must be performed with a warm disposable iv In the Hardware mode close the door the bag clamps and block the air vent on top of the reservoir chamber Disconnect the patient...

Page 20: ...nscrew the retaining screw that holds the pump head c Remove the pump head and clean with water and soap Hydrogen peroxide or a mild bleach solution can be used to disinfect d Let pump head dry before replacing and make certain the pump head is securely fastened with the retaining screw e If the pump head squeaks spray the roller with Silicone spray Heavy Duty Pure Silicone Retaining Screw Roller ...

Page 21: ...al Inspection a Right Hand Side b Back c Latch Unlatch if OK 2 Operational Check Out d PRIME e PT LINE PRIME f INFUSE g AC to DC switch over h DC to AC switch i Vacuum regulator if OK 3 Electrical Safety Check See attached Results Sheet a Earth Leakage Current b Patient Leakage Current if OK 4 Hardware verification a Valve Operation b Fluid Out and Air Detectors c Battery Voltage d Flow Rate e Inp...

Page 22: ...larity N Ground O Unit in STANDBY Neutral NORM Neutral OPEN Unit in ON not pumping Neutral NORM Neutral OPEN Unit in ON infusing 750 ml min Neutral NORM Neutral OPEN b Patient Leakage Currents all measurements are in μA Polarity N Ground N Polarity R Ground N Polarity R Ground O Polarity N Ground O Unit in STANDBY Neutral NORM Neutral OPEN Unit in ON not pumping Neutral NORM Neutral OPEN Unit in O...

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