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Chapter 4: Parameters Setting and Preventative Maintenance

41

F.

ELECTROMAGNETIC COMPATIBILITY

WARNING!

Medical Electrical Equipment needs special precautions regarding EMC and

needs to be installed and put into service according to the Electromagnetic

Compatibility [EMC] information provided in the accompanying documents.

WARNING!

Portable and Mobile RF Communications Equipment can affect Medical

Electrical Equipment.

WARNING!

The equipment or system should not be used adjacent to or stacked with other

equipment and that if adjacent or stacked use is necessary, the equipment or

system should be observed to verify normal operation in the configuration in

which it will be used.

NOTE

: The EMC tables and other guidelines that are included in the Instruction Manual provide

information to the customer or user that is essential in determining the suitability of the Equipment
or System for the Electromagnetic Environment of use, and in managing the Electromagnetic
Environment of use to permit the Equipment or System to perform its intended use without
disturbing other Equipment and Systems or non-medical electrical equipment.

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Summary of Contents for FMS2000

Page 1: ...OPERATOR S MANUAL The Belmont Rapid Infuser FMS2000 780 Boston Road Billerica MA 01821 USA 866 663 0212 US Canada 978 663 0212 Worldwide ...

Page 2: ...lkang Tech Consulting Suite B 29 Harley Street London W1G 9QR England United Kingdom Tel 44 20 32876300 Fax 44 20 76811874 All service calls questions should be directed to 855 397 4547 US Canada 978 663 0212 Worldwide CAUTION Federal law USA restricts this device to sale by or on the order of a physician P N 702 00001 Rev AH ...

Page 3: ...unting 5 Installing the Disposable Set 6 Installing the Optional Large Reservoir 7 Powering On the System 8 Installing Fluid Bag 8 Priming the Main System 9 Priming the Patient Line 9 Connecting to Patient 10 Match the Infusion Set to Flow Rate and Fluid Type 10 Initiating Infusion 10 Maintain Infusion 11 Pressure Control 11 Automatic Air Purging 11 Bolus Infusion Infuse a Fixed Volume 11 Recircul...

Page 4: ...Overtemp 18 Pump Fault 19 Valve Fault 19 Watchdog 19 Troubleshooting Other Operational Difficulties 20 CHAPTER 4 PARAMETERS SETTING AND PREVENTIVE MAINTENANCE Introduction 22 A System Setup 23 1 Date Time 24 2 Display Brightness 25 3 Key Rate 25 4 Bolus Volume 25 5 Pressure Limit 25 B Service and Preventive Maintenance Schedule 26 Schedule 1 26 Schedule 2 26 C Routine Maintenance 27 1 Clean and or...

Page 5: ... 5 Hardware Verification 33 6 Clean the pump head 38 E Checklist 39 F Electromagnetic Compatibility 41 G Fuse 43 H Calling for Service 43 CHAPTER 5 TECHNICAL SPECIFICATIONS Dimensions 44 Power AC 44 Battery 44 Environment 45 Operating Parameters 45 Operating Panel 46 Safety and Monitoring 46 Alarm States and Controls 47 Disposable Set 47 Classifications 48 Symbols and Definition 49 ...

Page 6: ...p allows for mobile transport of the patient During battery operation fluid warming is disabled while pump operation and safety monitoring remain active The built in rechargeable battery automatically charges whenever the system is connected to line power INDICATIONS FOR USE Infusion of crystalloid colloid or blood product including packed red blood cells as volume replacement for patients sufferi...

Page 7: ...ation 2 Power Switch turns system power on and off 3 Roller Pump is designed for pumping accuracy and reliability 4 Display and control panel show status and alarm messages with touch keys at the bottom of the screen 5 IR Temperature Probe Output Probe monitors output fluid temperature as it exits the Heat Exchanger 6 Air Detector detects air in the line If air is detected the valve wand is closed...

Page 8: ...nfusion of a fixed bolus of fluid is desired Function Keys The keys that control all system functions are displayed on the screen The screen is changed each time a function key is pressed Only keys that are relevant to the desired function are presented The active key is highlighted There are three 3 different levels of sensitivity Fast Medium and Slow The key sensitivity is set at the factory to ...

Page 9: ... WARNING Do not use with pressure infusers or bag squeezers The system pump provides adequate pressure to infuse fluid WARNING The Belmont Rapid Infuser FMS2000 is not for use in warming platelets cryo precipitates or granulocyte suspensions WARNING The Belmont Rapid Infuser FMS2000 is intended for infusion of high volume warm replacement fluid or blood component It is not intended for drug admini...

Page 10: ...urely clamped to an IV pole and will not tip over 1 Install the support assembly support clamp and washer approximately 30 from the ground While holding clamp closed loosen the screw to open up the clamp Install clamp on the IV pole holding clamp close and tighten screw using the supplied 3 16 Allen wrench Snap the plastic washer onto the IV pole above the support clamp 2 Lift up on the Pole Clamp...

Page 11: ...ump head Check that the thinner recirculate line is in the grove to the right Do not kink or twist the tubing 5 Place the pressure chamber into the pressure chamber well Firmly insert the wider infuse line into the air detector and to the left of valve wand Do not apply excessive pressure to the pressure transducer The pressure transducer can be damaged with excessive force Do not use the system i...

Page 12: ...e connector Disconnect the thinner recirculate line by unscrewing the connector 2 Attach the large reservoir holder onto the IV pole and place the reservoir into the holder 3 Assemble the large reservoir using aseptic techniques by attaching the three fluid supply tails onto the top of the reservoir 4 Connect the large reservoir to the luer of the 3 Spike disposable set 5 Adjust the reservoir hold...

Page 13: ... does not appear 3 PRIME screen will appear 4 Press NEXT to go to the PRIME screen If you turn power ON without the disposable set MISSING DISPOSABLE audible alarm message will appear Open the door or press MUTE to silence the alarm then install the disposable set INSTALLING FLUID BAG Install solution compatible with blood for the main system prime Prime Screen 1 Hang fluid bag s on the IV pole 2 ...

Page 14: ...alarm and instruct the user to unclamp the lines and resume prime If prime has to be stopped press STOP The prime volume countdown will remain on the screen Press RESUME PRIME to continue prime PRIME THE PATIENT LINE System Primed Screen Patient Line Primed Screen To remove air from the patient line 1 Open the roller clamp and remove the luer cap from the patient line 2 Press PT LINE PRIME Press o...

Page 15: ...be used exclusively for infusing blood components and solutions compatible with blood 1 Press INFUSE to start infusing at 10 ml min 2 Press 500 ML MIN key to infuse at 500 ml min or adjust flow rate as needed by pressing INFUSE RATE INFUSE RATE key increase decrease by 10 ml min There is no heat at 2 5 and 5 0 ml min settings Message LOW FLOW NO HEAT will flash on the screen indicates there is no ...

Page 16: ...ly set to 500 ml min if the flow rate is at or below 500 ml min and at the actual flow rate if the flow rate is above 500 ml min The RATE status line displays REMOVING AIR during this process The volume readout VOL remains unchanged during automatic air purging and resumes counting when infusion resumes When infusion resumes the system returns to the previously set rate Bolus Deliver fixed volume ...

Page 17: ... status line that displays temperature will be flashing BATTERY NO HEATING to indicate the system is now in battery mode the maximum flow rate is 50 ml min and heating is suspended 3 Adjust the flow rate by pressing INFUSE RATE or INFUSE RATE or press 50 ML MIN to immediately set the infuse rate to the maximum rate of 50 ml min 4 When the system is plugged back to the AC outlet the flow rate stays...

Page 18: ...tal policy when handling and disposing the bio hazardous materials 5 Follow the cleaning procedures outlined in Chapter 4 page 27 to clean and disinfect the system EMERGENCY MANUAL OPERATION In the event the system is not operational during a procedure fluid can be infused manually on an emergency basis using pressure or gravity WARNING In emergency manual operation all safety features of the syst...

Page 19: ...Alarm Message Screen Reprime Screen Air in the line Tubing in the air detection sensor is not seated firmly in the detector Leak in the disposable Air detector sensor dirty Air detector electronics defective Open the door to silence the alarm Check for air bubbles and possible leaks Squeeze the tubing directly below air detector to clear any trapped air out of the sensor There should be no trapped...

Page 20: ...Clogged air vent filter or coarse blood filter Reservoir or recirculate line is obstructed Detector electronics defective Press MUTE to silence the alarm If out of fluid add additional fluid and press REPRIME Open bag clamp or fully spike the bag Reseat the tubing in the fluid out detector and make certain that it is seated firmly in the sensor If the reservoir chamber stays empty during reprime t...

Page 21: ...e guide Match the Infusion Set to Flow Rate and Fluid Type on page 10 Increase pressure limit setting LOW BATTERY Plug the system into an AC outlet to continue operation and recharge the battery Allow at least 8 hours to fully charge the battery Battery voltage is too low If LOW BATTERY displayed while the system is connected to AC power one of the components may be defective Service machine If ba...

Page 22: ... OVER TEMPERATURE TURN OFF POWER DISCARD BLOOD AND DISPOSABLE RESTART SYSTEM WITH A NEW DISPOSABLE SERVICE MACHINE IF PROBLEM PERSISTS Fluid supply is over the temperature limit Temperature probes are wet dirty or blocked Restricted flow or out of fluid Check disposable set and flow path for occlusions Make certain the windows on the disposable set and the IR probes are clean and dry Clean surface...

Page 23: ... Power feedback circuit malfunction Restart the system and try again Power down and service machine if error persists HEATER OVER POWER FAULT HEATER OVER POWER FAULT PRESS RETRY TO CONTINUE SERVICE MACHINE IF ERROR PERSISTS Heater hardware fault Push RETRY to try again Power down and service machine if error persists POWER MODULE OVERTEMP POWER MODULE OVERTEMP FAULT KEEP THE AIR INTAKE AT THE BOTT...

Page 24: ...try to try again Power down and service machine if error persists VALVE FAULT VALVE FAULT CHECK VALVE FOR BLOCKAGE RESTART SYSTEM AND RETRY SERVICE MACHINE IF ERROR PERSISTS Valve failure Valve position sensor malfunction Check that the valve is not blocked Restart the system and try again Power down and service machine if error persists CAUTION Keep the patient line clamped closed when opening th...

Page 25: ...opriate infusion set recommended in the guide Match the Infusion Set to Flow Rate and Fluid Type Chapter 2 page 10 Increase flow by increasing the Pressure Limit Change the Pressure Limit in Calibration Setup to a higher limit maximum Pressure Limit is 300 mm Hg Chapter 4 page 25 Keypad does not accept input The keypad is being continually depressed Key pad failure Release the keypad and the const...

Page 26: ...ated properly Power module malfunction or temperature probes are out of calibration Examine the windows on the disposable set for wetness or contaminants Clean IR sensor window with soft cloth and alcohol if necessary The input temperature is too low and the flow rate is too high Service machine if problem persists System does not prime See Fluid Out in Alarm Message of this chapter Check the rese...

Page 27: ...tine maintenance as needed periodic maintenance at least once a year and parameters setting The instrument does not need regular calibration WARNING Practice standard precautions when handling blood products Treat all blood as if it were infected and clean up all spills immediately WARNING Test leakage current routinely to insure against electrical shock hazard CAUTION Turn the system to STANDBY a...

Page 28: ... Service mode 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 Calibration Set up Screen CALIBRATION SET UP TIME 23 59 DATE 12 31 14 BOLUS 200 ML PRESS LIMIT 300MMHG AC POWER PRESENT DATE TIME DISPLAY BRIGHT TEMP CAL PRESS CAL POWER C...

Page 29: ...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 DATE Scree...

Page 30: ...equired is not affected 4 Bolus Volume The bolus volume can be set from 100 to 1000 ml and can be changed from 100 200 400 500 and 1000 ml each time SETUP BOLUS key is pressed The current bolus volume is indicated at the BOLUS status line in the Calibration Setup screen The bolus volume is also displayed within the BOLUS key in the Infuse screen see Chapter 2 under Main Infuse screen 5 Pressure Li...

Page 31: ...4 Clean Temperature Probes 5 Check Clean the Fan Guard 6 Check the System Seal 7 Check Instrument Door and Ceramic Disk 8 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 2 Perform System Operational Check Out including the Audible Alarm Test 3 Check the batte...

Page 32: ... detectors clean and dry If 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 ...

Page 33: ...k hinges for blood build up clean any dried blood from hinge 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 in the center of the unit for cracks Return to manufacturer for replacement if they are damaged 8 Rubber Feet Inspect the rubber fee...

Page 34: ...at 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 the way down and there is no ...

Page 35: ...e 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 h Connect back to AC power and verify the operation is uninterrupted Adjust the flow rate by pressing INFUSE RATE i Infuse until the fluid bag is empty verify that the system s...

Page 36: ...d attach large clamp to equipotential ground terminal on the FMS2000 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 and Reverse Polar...

Page 37: ...p iii Prime the FMS2000 with saline Make sure that the entire patient line including the cannula has been primed iv Repeat a iii and a iv with the FMS2000 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 Not Grounded 50 µA...

Page 38: ...ICE 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 013192 Calibrati...

Page 39: ...s 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 th...

Page 40: ... 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 position and fill the pa...

Page 41: ...ously 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 OUTPUT TEMPERATURE value readings the values not between the parentheses should be within 2ºC iv Compare the numbers displayed on screen to the thermoco...

Page 42: ...the disposable is less compliant when it is at room temperature Verification must be performed with a warm disposable If the fluid is not warm go to the Main Infuse screen and warm the fluid and disposable by pressing the RECIRC key Chapter 2 Main Operating Screen Recirculating Mode Let the fluid recirculated for at least two minutes in AC power before returning to the Hardware mode for verificati...

Page 43: ...he 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 Pump ...

Page 44: ...PRIME e PT LINE PRIME f INFUSE g AC to DC switch over h DC to AC switch i FLUID OUT audible alarm 3 Battery Run Time test 30 min 4 Electrical Safety Check See attached Results Sheet if OK a Earth Leakage Current b Patient Leakage Current 5 Hardware verification a Valve Operation if OK b Fluid Out and Air Detectors if OK c Battery Voltage approx 24 V d Flow Rate if OK e Input and Output Temperature...

Page 45: ...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 ON infusin...

Page 46: ... used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used NOTE The EMC tables and other guidelines that are included in the Instruction Manual provide information to the customer or user that is essential in determining the suitability of the ...

Page 47: ...oncrete or ceramic tile If floors are synthetic the relative humidity should be at least 30 Radiated RF IEC 61000 4 3 3 V m 3 V m Radiated RF frequency is negligible at any single frequency Electrical Fast Transient burst IEC 61000 4 4 2kV on AC Mains 2kV on AC Mains Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kV Differential 2kV Common 1...

Page 48: ...ed as 1 25A 250V fast acting 5x20mm H CALL FOR SERVICE 1 855 397 4547 US Canada 1 978 663 0212 Worldwide Prior to returning any product please obtain a Return Goods Authorization RGA number Before calling please have the serial number of the unit The serial number is located on the label above the power receptacle ...

Page 49: ...or 230 V 16 amp dedicated Fuse 1 25A 250V Fast Acting 5x20mm Operating Frequency 50 60 Hz Maximum Power 1440 VA Line Isolation 1500 V to ground Earth Leakage Current 300 µA For Domestic unit 500 µA For 230 V unit Electrical Compliance EN 60601 1 CSA C22 2 No 601 1 M90 Circuit Breaker 15Amp 125VAC 250VAC 50 60 Hz Power Cord U S 3 conductors 14 AWG type SJT Cord with Hospital grade plug Outside U S ...

Page 50: ... to 8 centipoise Water and crystalloid fluids through packed red cells Tolerance 10 from 20 1000 ml min 25 for 2 5 5 0 10 ml min Output Temperature Set to 37 5ºC for flow 60ml min to 39ºC at 50ml min or lower Tolerance 1ºC for fluid temperature between 30ºC to 40ºC and 2ºC outside this range Heating Capacity Min 1400 watts to fluid 20ºC temperature rise at 1000 ml min Line Pressure 0 300 mm Hg via...

Page 51: ...ump will slow down until pressure falls below the threshold If the in line pressure rises faster than 40 mm Hg ml or exceeds 400 mm Hg an alarm sounds the HIGH PRESSURE message is displayed the line to the patient is closed and pump comes to an immediate stop Air Detection Two ultrasonic air detectors monitor air in the fluid path The fluid detector is mounted closest the fluid bag It sounds an al...

Page 52: ...tatus LOW BATTERY System Failures AIR DETECTOR FAULT PUMP FAULT VALVE FAULT HEATER FAULT LATCH HEAT POWER READ BACK FAULT HEATER OVER POWER FAULT POWER MODULE OVERTEMP HEATING FAULT WATCHDOG OVER TEMP DISPOSABLE SETS 3 Spike Disposable Set REF 903 00006 Filter Size 250 micron 3 0 Liter Reservoir REF 903 00018 Filter Size 160 micron 4 4 Liter Reservoir REF 902 00034 Filter Size 250 micron ...

Page 53: ...e flow path for single use only Degree of Safety in Presence of Flammable Anaesthetics Not suitable Mode of Operation Continuous Medical Equipment UL 60601 1 CAN CSA C22 2 No 601 1 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 2008 Medical General Medical Equipment As to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 ANSI AAMI ES60601 1 2...

Page 54: ...ce to Medical Device Directive 93 42 EEC Alternating current Equipotentiality Standby ON Caution or Consult accompanying documents refer to manual Defibrillator proof type CF equipment IPX2 Protected against dripping water SN Serial Number Manufactured by Authorized European Representative ...

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