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Table of Content

4. Electrical Safety Test - Leakage Current .................................. 7-90

a. Earth leakage Current .................................................. 7-90
b. Patient Leakage Current .............................................. 7-91

5. Hardware Verification .............................................................. 7-92

a.  Valve ............................................................................ 7-94
b.  Fluid Out and Air Detectors .......................................... 7-94
c.  Battery Voltage ............................................................ 7-94
d.  Flow Rate ..................................................................... 7-94
e.  Input and Output Temperature Probes ......................... 7-96
f.  Pressure Transducer .................................................... 7-97

6.  Clean Pump Head ................................................................... 7-98
7.  Replace Pump Motor ............................................................... 7-98
8.  Replace Valve Motor ............................................................... 7-98

D.

Checklist

...................................................................................... 7-99

Electrical Safety Test – Leakage Current results Sheet ............... 7-100
Electromagnetic Compatibility… .................................................. 7-101

Chapter 8: Alarms and Troubleshooting Guide

Introduction ................................................................................................... 8-103

Operational Alarms

..................................................................................... 8-104

1.

Air Detection………………………………………………………… 8-104

2.

Door Open……………………………………………………………..8-106

3.

Fluid Out...................................................................................... 8-107

•

Repriming the Main System Fluid Circuit when the

Reservoir Remains Empty After Extensive Operation ............ 8-108

•

Repriming the Main System Fluid Circuit when

Persistent Fluid Out Alarm occurs after
Extensive Operation .............................................................. 8-109

•

Replacing the Reservoir Chamber………………………………8-110

4.

High Pressure………………………………………………………… 8-111

5.

Low Battery…………………………………………………………….8-112

6.

Missing Disposable ..................................................................... 8-112

Troubleshooting Alarm Messages

……………………………………………..8-113

A.

Operational Alarms……………………………………………………8-113

•

Air Detection……………………………………………………… 8-113

•

Door Open……………………………………………………….. 8-113

•

Fluid Out …………………………………………………………8-114

•

High Pressure…………………………………………………… 8-115

•

Low Battery ………………………………………………………8-115

•

Missing Disposable……………………………………………… 8-115

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Summary of Contents for FMS2000

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

Page 2: ...g 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 00046 Rev AA ...

Page 3: ...ting Parameters 2 8 Operating Panel 2 9 Safety and Monitoring 2 9 Alarm States and Controls 2 10 Safety Agency Approvals Classifications 2 10 Symbols and Definitions 2 11 Chapter 3 Operation System Set up Step by Step Summary of Operating Procedures 3 12 Placement of the System 3 13 IV Pole Mounting 3 14 Installing the Disposable Set 3 15 Installing the 3 0 Liter Reservoir 3 19 Powering on the Sys...

Page 4: ...Wiring Interconnect Diagram 4 35 Theory of Operation 4 35 1 Power Module 4 35 EMI Filter Board 4 36 Driver A and B Boards 4 36 Heater Control Board 4 36 Heatsink Assembly 4 37 Operation 4 37 2 Daughter Board 4 38 Operation 4 39 Battery Control Circuitry 4 39 DC DC Power Supply 4 39 Pump Motor Driver 4 39 Valve Motor Driver 4 39 Valve Position Sensors 4 39 Pressure Transducer 4 39 RS232 Port 4 40 A...

Page 5: ...E Air Detector Transducer 5 50 F Battery 5 50 G C152 Replacement 5 51 H Ceramic Disk 5 52 I Circuit Breaker 5 53 J CPU PCB Display 5 54 K Daughter PCB 5 55 L Driver PCB A 5 57 Driver PCB B 5 57 Heater Control PCB 5 57 M EMI Filter PCB 5 59 N EPROM ICU 108 5 59 O Fan Guard 5 60 P Fluid Out Detector PCB 5 60 Q Fluid Out Transducer 5 61 R IEC Connector Power Entry Module 5 62 S Input Temperature Prob...

Page 6: ...Maintenance System Operational Check Out Introduction 7 83 A Service and Preventive Maintenance Schedule 7 84 Schedule 1 7 84 Schedule 2 7 85 B Routine Maintenance 7 86 1 Clean and or Disinfect Exterior 7 86 2 Fluid Out and In Line Air Detectors 7 86 3 Power Cord 7 86 4 Temperature Probes 7 86 5 Fan Guards 7 86 6 Seals 7 87 7 Instrument Door Ceramic Disks 7 87 8 Rubber Feet 7 87 C Test System Oper...

Page 7: ...magnetic Compatibility 7 101 Chapter 8 Alarms and Troubleshooting Guide Introduction 8 103 Operational Alarms 8 104 1 Air Detection 8 104 2 Door Open 8 106 3 Fluid Out 8 107 Repriming the Main System Fluid Circuit when the Reservoir Remains Empty After Extensive Operation 8 108 Repriming the Main System Fluid Circuit when Persistent Fluid Out Alarm occurs after Extensive Operation 8 109 Replacing ...

Page 8: ...ting 8 120 Dim display 8 120 Flow rate slowing down 8 120 Key pad not accept input 8 120 Keypad too sensitive not responsive 8 120 No message beep tone 8 120 No power battery run too short 8 121 Power off immediately after turn on 8 121 Pump running too loud 8 122 System not heating 8 121 System not priming 8 121 Unable to calibrate temperature probe 8 122 Unable to turn power off 8 122 Chapter 9 ...

Page 9: ... air in the fluid path to ensure safe operation and alarms at all unsafe conditions A hardware override circuit prevents unsafe operation in case of system computer failure A touch screen displays flow rate total fluid infused temperature line pressure alarm and status messages and proper procedures to proceed safely after an alarm situation Keys appropriate to a particular point in the operation ...

Page 10: ...r o A Monitoring Alarm system for sensing and analyzing Infusate Flow Rate Fluid Temperature Line Pressure Air Bubbles in the Infusate The Disposable Set is preconnected and has a sterile fluid path It is intended for single patient use only It connects directly to fluid or blood bags and contains components necessary to pump and warm the infusate and interfaces directly to temperature air and pre...

Page 11: ...t Detector Behind Pump Head Tubing Display Heat Exchanger Pressure Transducer Behind Pressure Chamber Pressure Chamber In Line Air Detector Power Switch Fluid Pump Pump Head Tubing Output Infrared Temperature Probe Inside case Input Infrared Temperature Probe Inside case Valve ...

Page 12: ...mperature of the heated fluid as it leaves the heat exchanger is displayed on the screen The system corrects for overheating or underheating and will shut off and alarm at unsafe conditions The system is capable of heating fluids from 10ºC to 37 5ºC at 750 ml min and 20ºC to 37 5ºC at 1000 ml min PRESSURE MONITORING A pressure sensor monitors the line pressure of the infusate Line pressure is dire...

Page 13: ...d heating stop An alarm sounds and the Air detection warning message is displayed on the screen A graphic message appears showing the location of the air detector which signaled the warning and gives instructions on how to clear the alarm and proceed safely DIVERSION VALVE The diversion valve motor is capable of running in two 2 directions The diversion valve shuts off the recirculation line when ...

Page 14: ...us Volume when infusion 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...

Page 15: ...wer 1440 VA Line Isolation 1500 V to ground Earth Leakage 300 µA For Domestic unit 500 µA For 230 V unit Electrical Compliance IEC 60601 1 A1 A2 EN 60601 1 A1 A2 A11 A 12 A 13 CAN CSA C22 2 No 601 1 M90 S1 A2 Circuit Breaker 15Amp 125VAC 10 Amp 240VAC 50 60 Hz Power Cord U S 3 conductors 14 AWG type SJT Cord with Hospital grade plug Outside U S 3 x 1 5 mm2 International Harmonized Cordage with Hos...

Page 16: ...on in 10 ml min steps plus 2 5 and 5 0 ml min with fluids of viscosity 1 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 60 ml min to 39ºC at 50ml min or lower Heating Capacity Min 1400 watts to fluid 20ºC temperature rise at 1000 ml min Line Pressure 0 300 mmHg via pressure tr...

Page 17: ...ressure falls below the threshold If the in line pressure rises faster than 40 mmHg ml or exceeds 400 mmHg 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 to the fluid bag It sounds an alarm if there is no fluid ...

Page 18: ...ee of Protection Against Electric Shock CF defibrillator proof Degree of Protection Against Harmful Ingress of Water IPX2 Drip proof Method of Sterilization Disposable delivered sterile single use Degree of Safety in Presence of Flammable Anesthetics 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 ...

Page 19: ...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 S N Serial Number Manufactured by Authorized European Representative ...

Page 20: ...g Open bag clamps PRIMING o Priming Main System with solution compatible with blood Press PRIME recirculate fluid at 500 ml min stop automatically after 100 ml countdown is displayed on screen o Priming the Patient line Press PT LINE PRIME Press once prime at 50 ml min Press and hold prime at 200 ml min Press STOP after no air in patient line INITIATING INFUSION o Connect to the Patient Select an ...

Page 21: ...her onto the IV pole above the support clamp Tighten the screw in the support clamp with a 3 16 Allen Wrench 3 Support the FMS2000 by the top mounted handle prior to opening the Pole Clamp Release Handle Lift up on the Pole Clamp Release Handle to open Mount the system onto the IV pole by pushing down on the pole clamp release handle at the desired height Check that the system is locked in place b...

Page 22: ...000 with support assembly Clamp and Washer 5 Make certain that there is nothing obstructing the air vents at the bottom of the system 6 Do not operate the system while it is lying on its side IV POLE FMS UNIT SUPPORT CLAMP PLASTIC WASHER RESERVOIR SUPPORT ...

Page 23: ...s Bag Spikes Bag Spike Vent Caps Bag Clamps Reservoir Chamber Heat Exchanger Check Valve Fluid Out Detector Air Detector Interlock Block Pump Head Pump Tubing Recirculate Line Patient Line Patient Line Vent Cap Roller Clamp Infuse Line Valve Wand Pressure Chamber Coarse Filter Air Vent Red Tinted Tubing ...

Page 24: ...ly anticoagulated blood products WARNING Practice standard precautions when handling blood products Treat all blood as if it were infected and clean up all spills immediately CAUTION Keep the windows on the disposable set and the IR probe clean and dry Avoid touching them If the windows become dirty or wet clean with a soft cloth with alcohol and dry CAUTION Do not alter or change any part of the ...

Page 25: ... Firmly position the interlock block into the fluid out detector 3 Guide the curved piece of pump tubing over the pump head and position the pump tubing into the groove Check that the thinner recirculate line is in the groove to the right 4 Place the pressure chamber into the pressure chamber slot Move valve wand slightly to the middle Insert the wider infuse line into the air detector and to the ...

Page 26: ...romechanical device and can be damaged with excessive force Do not use the system if the pressure transducer is damaged CAUTION For proper operation keep the fluid out detector and pump tubing clean and dry Do not block the air vent on the top of the reservoir chamber 6 Close the door Make certain the tubing is not crimped or caught in the door Connect the patient line Pressure Transducer Air Dete...

Page 27: ...s Completely clamp off the larger pump tubing Disconnect the larger pump tubing by pressing in the luer lock tab and pulling the connector out Disconnect the thinner recirculate line by unscrewing the connector 2 Assemble the 3 0 L Reservoir using aseptic techniques by first attaching the three fluid supply tails onto the top of the reservoir 3 Connect the 3 0 L Reservoir to the luer of the 3 spik...

Page 28: ... Make certain the two connection leads underneath the reservoir are not stretched or kinked Stretched or kinked connection leads can cause flow restrictions and frequent Fluid Out alarms 6 Install the 3 spike disposable set into the FMS2000 as previously shown CAUTION Do not pressurize or apply a vacuum to the reservoir ...

Page 29: ...lf check to check the integrity of system parameters 4 AC POWER PRESENT appears at the logo screen when the system first powers up Check the power cord and AC receptacle connections if the statement does not appear 5 PRIME screen Figure 2 will appear a If you turn power ON without the disposable set MISSING DISPOSABLE message and alarm will appear Figure 1 b Open the door or press MUTE to silence ...

Page 30: ...h fluid 2 Prime the Patient Line The patient line prime is done under user control to remove all air from the patient line PRIMING THE MAIN SYSTEM a Completely close all bag clamps Remove the bag spike cap s and insert bag spike s into the fluid bag s pierce it fully to ensure that fluid flows freely Unclamp bag clamp s b When hanging the fluid bag above the machine the pump tubing that is seated ...

Page 31: ...le set when the filter becomes clogged to maintain proper flow If it becomes occluded the fluid out sensor will activate an audible alarm will sound a message Fluid Out Check inlet tubing and filter Add more fluid will appear and the pump will stop CAUTION Immediately wipe any spills from the device e Prime the system with crystalloid that is under 42ΕC Infusing fluids 42ΕC and over will trigger t...

Page 32: ...the Prime h If Prime has to be stopped press STOP This does not bypass the full prime The prime volume countdown will remain on the screen To continue Prime press RESUME PRIME When the process is complete no air should remain in the main system fluid circuit CONTROLS PRIME Press the PRIME key to prime the reservoir heat exchanger pressure chamber and tubing by recirculating 100 ml of fluid at 500 ...

Page 33: ... primes the patient line with warm fluid b Press PT LINE PRIME once to prime at 50 ml min or press and hold the key to prime at 200 ml min c Press STOP or engage the roller clamp first and then press STOP to stop the flow when the patient line is fully primed Figure 5 Inspect the patient line for air bubbles Figure 4 System primed ready for Patient Line Prime Figure 5 Patient Line Prime ...

Page 34: ...e flow rate 2 Maximum allowable flow rate depends on various factors such as the viscosity of the fluid the length and diameter of the cannula and patient line High viscosity long patient line or small bore cannula will reduce the maximum allowable flow rate 3 Use aseptic techniques to make the patient connection without entrapping air 4 Press INFUSE to go to the Infuse screen and start infusing a...

Page 35: ... that the entire fluid path is completely primed and free of air before administering fluid to the patient Failure to do so may result in the introduction of air into the patient STOP Stops pumping and heating The system is in standby ready to continue on request INFUSE After properly priming the system press INFUSE to go to the main operating screen and start infusion at 10 ml min WHEN PT LINE PR...

Page 36: ... of 500 ml min BOLUS The FMS2000 will pump the volume indicated on the BOLUS key at a rate of 200 ml min The bolus volume on the key can be set in the Service mode see Chapter 6 or by pressing and holding down the BOLUS key while in the Infuse screen Release the key when the desired BOLUS volume appears in the volume delivered position The bolus delivery rate can be changed while infusing by eithe...

Page 37: ...inues to be active CAUTION The system can infuse fluid at rates up to 750 ml per minute with 1000 ml min option A unit of blood will be emptied in less than one minute at this rate CAUTION Routinely check patient and system parameters on screen Respond to and correct system alarms Replace the reservoir chamber or disposable set when the filter becomes clogged The Fluid Out alarm will occur when th...

Page 38: ...ettings Message LOW FLOW NO HEATING flashing on the screen indicates that the system is not heating at low flow rates Pressure Control Pressure control regulates the pump speed to keep line pressure under the user set pressure limit The pressure status line flashes and a periodic beep sounds while the system is under pressure control Line pressure is mainly due to the small orifice of the infusion...

Page 39: ...actory to 200 ml This can be changed in the Calibration Set Up screen see Chapter V or by pressing and holding the BOLUS key in the Infuse screen The new bolus volume will appear in the VOL volume status line with the prefix of BOL bolus Releasing the Bolus key will start the infusion To change the flow rate during the bolus infusion press the RATE RATE or 500 ml min keys At the end of the bolus v...

Page 40: ...me operation END OF PROCEDURE Clamp off the patient line and bag spikes at the end of the procedure Turn the system to STANDBY using the circuit breaker first then remove the disposable set from the system Make certain the patient line is clamped shut when the door of the system is open while the system is powered off to prevent uncontrolled fluid flow Follow the cleaning procedures outlined in Ch...

Page 41: ...d main system fluid path Unplug the system the 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 Adjust the flow rate by pressing INFUSE RATE or INFUSE RATE Press 50 ml min RATE key to immediately set the infuse rate to the maximum rate of 50 ml min or the maximum rate ...

Page 42: ...ng a procedure fluid can be infused manually on an emergency basis using pressure or gravity as follows 1 Bypass the system by switching to STANDBY on the circuit breaker 2 Open the door 3 Remove the infuse line from the valve wand The rest of the disposable set may be left intact in the instrument or may be removed Opening the door will allow the fluid to bypass the roller pump 4 Apply pressure a...

Page 43: ...breaker and a power entry module The manual is designed to familiarize the service personnel with each module so that troubleshooting and or replacement can be done on a module level 1 Power Module The power module consists of EMI filter board Driver A and Driver B boards Heater Control board and Heatsink Assembly DRIVER BOARD A HEATER CONTROL BOARD DRIVER BOARD B EMI BOARD AC AC DC SUPPLY CIRCUIT...

Page 44: ...ard The heater control board contains the following functions heater driver signal generation non volatile memory power measurement fan speed control over temperature for the heatsink watchdog and system interface The heater control board receives control data from the computer board through a serial interface as well as line phase information and driver circuit fault monitoring signals from drive...

Page 45: ...ed based on the output power that it requests If the over temperature switch is activated the fan will go as fast as possible regardless of the computer command and the computer is notified of the over temperature condition If the over temperature condition exists for a fixed period of time pumping and heating stop When the power switch is turned off and the system is plugged into an AC line the f...

Page 46: ...LIFIER REFERENCE VOLTAGE TEMPERATUR E REFERENCE VALVE POSITION DOOR POSITION FLUID OUT ELECTRONICS AIR DETECTOR ELECTRONICS ON OFF SWITCH BATTERY CHARGER DC DC SUPPLY EMI FILTER BATTERY FROM FLUID OUT FROM AIR DET ALARM PRESS AMP 5VDC 100VDC 105VDC 80VDC 30VDC TO SYSTEM ON OFF CONTROL TO CPU BD TO CPU BOARD TO CPU BOARD PUMP MOTOR VALVE MOTOR RS232 CONNECTOR ...

Page 47: ...n the motor communicating with the computer board The valve motor driver contains two parts the motor power driver and current monitoring circuitry The driver consists of four power MOSFETS in a bridge configuration which is capable of driving the motor in both directions The current monitor circuitry sends a voltage to an analog to digital converter ADC input of the microcontroller system that is...

Page 48: ...is pressed into the slot of a sensor containing piezoelectric crystals The piezoelectric crystals send and receive pulses of ultrasonic energy through the tubing and the fluid Sound travels at a slower rate through air than it does through liquid The tubing must be firmly pressed into the slot of a sensor to assure adequate acoustic coupling between tubing and the sensor The two 2 air detectors ar...

Page 49: ...E VALVE CURRENT INPUT THERMOPILE VOLTAGE THERMOPILE REF ON OFF SWITCH 5V REF DOOR OPEN DETECTOR RS232 PORT RAM ROM RTC RAM WATCHDOG DATA ACCESS CONTROL BATTERY DISPLAY CONTROL SYSTEM VALVE MOTOR WATCHDOG PUMP MOTOR WATCHDOG DISPLAY MEMORY RESET CONTROL MOTOR SPEED DIRECTION AIR DETECTOR TEST SOUND CONTROL KEYBOARD SCAN VALVE MOTOR CONTROL PUMP MOTOR CONTROL FLUID OUT DETECTOR AIR DETECTOR ON OFF S...

Page 50: ...byte RAM upper byte display FPGA and motor FPGA The board contains three types of memory EPROM RAM and battery backed up RAM The EPROM is used to boot the system on power up and to store the main program when the power is off The system RAM is used for running the program and temporary constant storage The battery backup RAM is used for storing calibration constants that are generated during the s...

Page 51: ... scans the keyboard provides valve control tests the air detectors and watchdog functions A display driver circuit provides level shifting for the 0 to 5 volt logic circuits down to 105 to 100 volts A buffering circuit provides the necessary driving capacity to drive the cable to the power module An array of comparators is used to sense the signals from the keyboard on the touch screen panel ...

Page 52: ...ed DC The supply contains its own EMI filter and provides a regulated output The supply uses a flyback topology and is capable of 35 watts continuous power The supply is used to charge the battery and to provide DC power to run the system electronics BRIDGE RECTIFIER FLYBACK TRANSFORMER AC FROM EMI BOARD 30VDC ISOLATED FUSE EMI FILTER REGULATOR ...

Page 53: ...eces mounts to the door and the other piece along with the bobbin heater winding and heater housing are mounted in the support housing The membrane panel switch touch screen for user interface contains a transparent area through which the display is viewable and a 4 x 4 matrix of buttons The buttons are overlaid on the bottom four fifths of the screen A graphic boarder contains the company name an...

Page 54: ...e and one measures the output fluid temperature of the heat exchanger These are infrared IR sensors that look into the fluid path through infrared transparent germanium windows on the devices and thin plastic film on the disposable set The temperature probe circuit board within each assembly contains a precision amplifier for the IR sensor output The voltage generated is proportional to the differ...

Page 55: ...stem parameters setting calibration and or operational check should be performed see Chapter 6 and 7 Drawings and Bills of Material BOM s are included Proper ESD precautions are required for all electronic assemblies REQUIRED MATERIAL TOOLS 1 Pliers needle nosed 2 Screwdriver 2 Phillips head 3 Allen Wrench 3 32 4 IC Removal Tool 5 Kapton Tape 6 Teflon Grease or equivalent 7 RTV sealant Dow Corning...

Page 56: ...ery to Daughter PCB cable to Daughter PCB JP13 2 Carefully slide Instrument Cover back onto Support Housing Do not pinch the battery cable 3 Reinstall 6X flat head Phillips screws 4 Apply a thin bead of silicone around entire perimeter of Instrument Cover and allow at least 1 hour for silicone to dry B AC DC PCB Reference Drawing 403 00107 Removal 1 Ground strap must be worn 2 Refer to Step A Remo...

Page 57: ...d flat washer D AIR DETECTOR PCB Reference Drawing 403 00107 If P N 310 00024 is used this Air detector PCB is not needed Removal 1 Ground strap must be worn 2 Refer to Step A Removal 1 7 to remove the instrument cover 3 Carefully pinch the top of 2X Air Detector Sensor Standoffs gently pull Air Detector PCB off 4 If P N 310 00024 Air Detector Sensor is used discard this Air detector PCB Installat...

Page 58: ...back surface and screw holes of the air detector 4 Remove Air Detector Electronic PCB and discard refer to Step D Refer to Step K Installation to reinstall the Daughter PCB Plug the sensor connector to JP12 on the Daughter PCB F BATTERY Reference Drawing 403 00108 Removal 1 Refer to Step A Removal 1 7 to remove the instrument cover 2 Unplug lugs from battery terminals and slide batteries out of th...

Page 59: ...e Step J 4 Locate C152 position Use a solder pull or solder wick to remove left over solder Installation 1 Ground strap must be worn 2 Position C152 on CPU PCB and solder in place Figure 3 3 Reinstall CPU PCB See Step J 4 Refer to Step A Installation 1 5 to reinstall the instrument cover Figure 3 CPU Board MEMBRANE PANEL CABLE DAUGHTER PCB CABLE IC U108 PIN 1 C 1 5 2 FRONT SCREW FRONT SCREW BACK S...

Page 60: ... Gasket Installation 1 Remove one side of the protective covering from Disk Gasket 2 Press the Disk Gasket onto the center of Ceramic Disk 3 Remove the other protective covering from the Disk Gasket 4 Place Ceramic Disk with the Disk Gasket side down into the cutout in the Door Do not allow the walls of the Door to touch the Ceramic Disk 5 Apply a thin bead of silicone around entire perimeter of C...

Page 61: ... PCB 4 Unplug Daughter PCB Cable 5 Remove 4X lugs from circuit breaker 6 Remove circuit breaker and the spacer block Installation 1 Install spacer block between Support Housing and Circuit Breaker Reinstall 4 X pan head Phillips screws connecting Circuit Breaker to Support Housing 2 Reattach Daughter PCB Cable Figure 4 3 Reattach 4X lugs to circuit breaker Figure 4 4 Refer to Step B to reinstall A...

Page 62: ...Store Display in a static proof bag Installation 1 Ground strap must be worn 2 Align connector pins on CPU PCB with mating connector on Display and gently push together Caution do touch the top of the Display 3 Insert 2X pan head Phillips screws through the back holes in CPU PCB through 2X standoffs Display Figure 3 4 Secure with 2X nuts 5 Insert 2X pan head Phillips screws through the front holes...

Page 63: ...c proof bag Installation 1 Ground strap must be worn 2 Apply Teflon grease to the pressure transducer O ring 3 Carefully insert Daughter PCB into Support Housing Make certain the 4X Micro Sensors on the back of the PCB are not bent and the pressure transducer is seated correctly in its receptacle 4 Reinstall 12X pan head Phillips screws 2X nylon washers Figure 5 5 Reattach all cables connected to ...

Page 64: ...DAUGHTER PCB continued NYLO N W ASHER FLUID OUT DETECTOR ELECTRONIC NOT USED IF USES 310 00023 CB ASSY PUMP MOTOR C P U P C B M A X O N C A B L E OUPUT TEMP PROBE INPUT TEMP PROBE PO W ER DR IVER M O DULE R S 2 3 2 INSTRUMENT COVER NYLON WASHER Figure 5 Daughter PCB ...

Page 65: ...r Mounting Blocks 8 Store Driver PCBs A B in static proof bags 9 Remove 4X pan head Phillips screws from Heater Control PCB 10 Remove Heater Control PCB and store in a static proof bag Installation 1 Ground strap must be worn 2 Slide Driver PCBs A B into Driver Mounting Blocks 3 Reinstall 4X pan head Phillips screws Transistor Mounting Clamps 4 Reinstall 6X pan head Phillips screws into each side ...

Page 66: ...ement of Major Components and Modules 5 58 L DRIVER PCB A DRIVER PCB B HEATER CONTROL PCB continued CO NTRO L PCB TRANSISTOR MOUNTING CLAMPS DRIVER PCB A DRIVER PCB B CONTRO L PCB Figure 6 Driver A B and Heater Control PCB ...

Page 67: ...tem Operational Check Out Chapter 7 N EPROM ICU 108 on CPU Board REPLACEMENT Reference Drawing 403 00107 Removal 1 Ground strap must be worn 2 Remove the instrument cover See Step A Removal 1 7 3 Lay the unit flat on the door 4 Unplug membrane Panel cable from CPU PCB 5 Use the IC Removal tool pull EPROM ICU 108 from the socket of CPU PCB Installation 1 Ground strap must be worn 2 Insert EPROM ICU...

Page 68: ... be worn 2 Refer to Step B AC DC PCB Removal to remove the instrument cover and the board 3 Carefully pinch the top of 2X Fluid Out Detector PCB plastic Standoffs and gently pull Fluid Out Detector PCB off the standoff 4 If P N 310 00023 Fluid Out Sensor is used discard this Fluid Out detector PCB Installation 1 Ground strap must be worn 2 For P N 310 00007 Only Place Fluid Out Detector PCB over t...

Page 69: ...ws and the spacer 6 Gently push the case through the front of the Support Housing Installation 1 Feed the sensor connector through the front of the Support Housing 2 Align the detector with its mounting holes Install the spacer not needed for P N 310 00023 and fasten the two screws onto the air detector 3 Apply RTV silicone to entire back surface and screw holes of the air detector 4 Remove Air De...

Page 70: ...5 Remove IEC Connector by pinching the top and bottom of connector and sliding it out of the Support Housing Installation 1 Attach flat washer AC Ground Cable flat washer lock washer nut to Ground Stud in that order Figure 7 2 Insert IEC Connector into Support Housing and snap in place 3 Reinstall Power Driver Module See Step V 4 Reinstall Blue wire to JP2 and Brown wire to JP5 on the EMI board LO...

Page 71: ...t Temperature Probe Installation 1 Insert Input Temperature Probe into Support Housing with the sensor window facing the center of the Housing Apply RTV silicone to entire back surface and screw holes 2 Reinstall 2X pan head Phillips screws 3 Apply a bead of silicone around the outside perimeter of Input Temperature Probe and allow silicone to dry for at least 1 hour 4 Twist cable then reattach In...

Page 72: ...pport Housing along the sides and in the corners Installation 1 Remove protective backing from back surface of Membrane Panel and adhere to pocket in Support Housing Caution do not touch back surface of Membrane Panel 2 Reattach Membrane Panel Ground Strap to Support housing with 1X flat washer and 1X pan head Phillips screw 3 Apply tape over Membrane Panel Ground Strap to secure in place 4 Reatta...

Page 73: ... to Support Housing Gently push probe out from the inside Installation 1 Insert Output Temperature Probe into Support Housing with the sensor window facing the center of the Housing Apply RTV silicone to entire back surface and screw holes 2 Reinstall 2X pan head Phillips screws 3 Apply a bead of silicone around the outside perimeter of Output Temperature Probe and allow silicone to dry for at lea...

Page 74: ...Module and store in a static proof bag Installation 1 Ground strap must be worn 2 Reinsert Power Driver Module into Support Housing making sure the EMI PCB fit into the slot on the Support Housing 3 Reinstall 4X flat head Phillips screws and Fan Guard 4 Reinstall 4X pan head Phillips screws attaching Power Driver Module to Support Housing 5 Reattach Bobbin Assembly Cable and Daughter PCB Cable 6 R...

Page 75: ...WER DRIVER MODULE continued Figure 8 Power Module Assembly CONNECTS TO IEC CONNECTOR CONNECTS TO IEC CONNECTOR 2X CONNECTS TO ON OFF SWITCH 2X CONNECTS TO AC DC PCB 2X CONNECTS TO ON OFF SW ITCH CONNECTS TO DAUGHTER BOARD PCB CONNECTS TO BOBBIN ASSEMBLY CAPACITOR BLOCK ...

Page 76: ...remove left over solder Installation 1 Ground strap must be worn 2 Locate the notch on the Pressure Transducer insert the Pressure Transducer into Daughter PCB Solder Side notch is at Pin 1 Solder in place 3 Remove O ring from Pressure Transducer 4 Apply a thin film of Teflon Grease over O ring 5 Apply Kapton Tape over Pressure Transducer reattach O ring 6 Reinstall Daughter PCB See Step K 7 Reins...

Page 77: ... Shaft Adapter 6 Remove 4X flat head Phillips screws attaching Pump Motor to Support Housing 7 Remove Motor Pump Spacer Pump Motor Installation 1 Slide Motor Pump Spacer over Pump Motor and attach to Support Housing with 4X flat head Phillips screws 2 Slide Pump Shaft Adapter over Pump Motor Shaft use a 16 AWG wire as a tool to gauge the space between the Pump Motor Shaft and Support Housing then ...

Page 78: ... Remove Valve Pincher 5 Remove 3 flat head Phillips screws attaching Valve Motor to Support Housing 6 Remove Valve Motor Installation 1 Reattach Valve Motor to Support Housing with 3X flat head Phillips screws 2 Slide Valve Pincher over Valve Motor Shaft and secure with 1X set screw 3 Reattach connector to Daughter PCB 4 Refer to Step A Installation 1 5 to reinstall the instrument cover Note Older...

Page 79: ...n max rate 403 00343 Assembly Final 120 V unit 1000 ml min max rate 403 00108 Assembly Instrument Cover 403 00109 Assembly Instrument Door 403 00132 Assembly Power Driver Module 403 00248 Assembly Final 230 V unit 750 ml min max rate 403 00344 Assembly Final 230 V unit 1000 ml min max rate 403 00270 Assembly Circuit Breaker 230 V unit 903 00001B FMS Packaging Military 120 V Field Version ...

Page 80: ... Hardware Verification Chapter 7 WARNING Do not access system parameters setup while the instrument is patient connected Changes in system setup can be made to 1 Date and time Set the real time clock and date 2 Display brightness Change the display brightness 3 Key Rate Set touch key sensitivity 4 Bolus volume Set the bolus delivery volume 5 Pressure limits for High Pressure alarm Set the maximum ...

Page 81: ... 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 CAL MEDIUM KEYRATE PRESS LIMIT HARD WARE SETUP BOLUS EXIT SERVICE ...

Page 82: ...merical 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 Screen ...

Page 83: ...e required is not affected 4 Bolus Volume The bolus volume can be set from 100 to 1000 ml except 250ml for British Military units 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 Chapt...

Page 84: ...are displayed Calibration of the system is done at the factory A password is required to calibrate the system to insure that this mode is not accessed accidentally Calibration must be done in the following order 1 Pressure sensor 2 Temperature probes 3 Power module and pump Materials needed for calibration New disposable set Manometer or gauge up to 300 mmHg 2 mmHg resolution Pressure source Therm...

Page 85: ...ower ON Press SERVICE when it appears at the logo screen 1 2 Press HARDWARE Enter the password 013192 1 3 Warm the Disposable set 1 3 1 Attach water 37º 43ºC to the disposable set and open the clamps Make certain the water is warm The pressure chamber of the disposable is less compliant when it is at room temperature Calibration must be performed with a warm disposable 1 3 2 Press PUMP SPEED three...

Page 86: ... with a manometer 1 4 4 Apply 100 mmHg of pressure Press UPDATE to accept the 100 mmHg calibration point 1 4 5 Apply 258 mmHg of pressure Press UPDATE to accept the calibration point The system will return to the main Calibration Setup screen 1 5 Calibration Verification 1 5 1 Press HARDWARE Enter the password 013192 1 5 2 Press RIGHT VALVE to set the valve in the right position 1 5 3 Apply 258 mm...

Page 87: ...mperature probe to the nearest 0 1ºC iii Prepare 4 liters each of three 3 different temperatures water 1º 7ºC 17º 23ºC and 37º 43ºC iv Install the 3 0 L Reservoir and the 3 Spike disposable set Do not connect the patient line v Insert the thermometer into the patient line connector as close to the heat exchanger as possible Make sure there is no air surrounding the thermometer bulb Procedure Calib...

Page 88: ...ual temperature 2 6 40 3ºC Calibrate 2 6 1 Add 40 3ºC water to the 3 0 L Reservoir Repeat 2 7 After the last temperature water 40 3ºC is updated the system will return to the Calibration Set Up screen Verification 2 8 Press HARDWARE Enter password 013192 2 9 Add more 40 3ºC water to the 3 0 L Reservoir 2 10 Press the RIGHT VALVE key to set the valve to the infuse position 2 11 Press the PUMP SPEED...

Page 89: ...servoir and 3 Spike disposable set Procedure Calibration 3 1 Power ON Press SERVICE when it appears at the logo screen 3 2 Press HARDWARE Enter password 013192 3 3 Determine the actual maximum flow rate 3 3 1 Open bag clamps and prepare to prime the disposable 3 3 2 Press PUMP SPEED three times to set pump speed to 500 ml min This will recirculate the system with fluid and prime the main fluid cir...

Page 90: ...t eleven minutes 3 4 4 Keep the 3 0 L Reservoir filled with cold fluid during the entire procedure Power calibration screen waiting to update 3 4 5 The input and output temperature to the heat exchanger will be displayed Wait for the DT value the difference between input and output temperature to stabilize When the system has stabilized the UPDATE key will appear 3 4 6 Press UPDATE to complete the...

Page 91: ... blood as if it were infected and clean up all spills immediately WARNING Test leakage current routinely to insure against electrical shock hazard WARNING Do not perform PREVENTIVE MAINTENANCE while the system is connected to a patient CAUTION Turn the system to STANDBY and unplug the power cord before cleaning to avoid electric shock ...

Page 92: ...ified service personnel Schedule 1 To be performed by either the Clinical User or a Biomedical Technician BMET Routine Maintenance Interval Before or After Each Use Every Month Every 6 Months 1 Clean and or Disinfect Exterior if necessary 2 Clean Fluid Out and In Line Air Detector 3 Check the Power Cord 4 Clean Temperature Probes 5 Check Clean the Fan Guard 6 Check the System Seal 7 Check Instrume...

Page 93: ...6 Months Every Year Every 5000 Hrs 1 Perform Visual Inspection 2 Perform System Operational Check Out including the Audible Alarm Test 3 Check the battery for rated voltage and check battery run time Replace batteries when operating time is marginal or after 3 years 4 Perform Electrical Safety Test 5 Hardware Verification 6 Clean Pump Head 7 Replace Pump Motor 8 Replace Valve Motor ...

Page 94: ...eep the fluid out and air 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 replacement part 118 00096 US and part 118 00085 International 4 Temperature Probes Keep t...

Page 95: ...r pump is located on the door The platen must line up properly with the pump a Check 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 Replace or r...

Page 96: ... the detectors and the Support Housing If there are gaps fill the gap with RTV108 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 freel...

Page 97: ...hat 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 Press 500 ml min Verify the temperature during steady state on the screen and from the thermocouple The ...

Page 98: ...nt of Bio Tek Safety Analyzer CAUTION Before applying voltage to Bio Tek make sure input line voltage is correct for the VOLTAGE OF UNIT UNDER TEST Switch found on the back of Bio Tek 115 or 230 V a Earth Leakage Currents i Plug the Bio Tek into an appropriate power source turn Bio Tek power ON FMS2000 power switch To Standby ii Switch selector on Bio Tek to CHASSIS or LEAKAGE µA Connect a single ...

Page 99: ... Patient Leakage Current i Install the disposable set and prime with saline and proceed to the Infuse screen ii Attach 12 to 16 gauge stainless steel cannula to the end of patient line and attach the Bio Tek large clamp to the cannula 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 STAND...

Page 100: ...nd f Pressure sensor A password is required to access 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 Press HARDWARE from the Calibration Set Up screen Enter the Password 013192 Calibration Setup screen CALIBRAT...

Page 101: ... 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 the...

Page 102: ...tlet check Battery voltage displayed in HARDWARE screen should be approximately 24 volts If not recharge the battery for at least 8 hours and recheck Plug the unit back into 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 M...

Page 103: ...by using a tachometer vi Close the door Set the pump speed to 10 ml min Use a tachometer to measure the rotational speed of the pump head The accepted tolerance is 1 95 rpm 25 vii Press PUMP SPEED again to change the pump speed to 100 ml min The accepted tolerance is 19 65 rpm 10 viii Press once more to change speed to 500 ml min and repeat the measurement The accepted tolerance is 97 rpm 10 ix Pr...

Page 104: ...he 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 to the thermocouple reading The accepted tolerance is 1ºC for fluid tem...

Page 105: ...le 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 Let the fluid recirculated for at least two minutes in AC power before returning to the Hardware mode for verification iv In the Hardware mode close the bag clamps and block the a...

Page 106: ...ump 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 Teflon spray Heavy Duty Pure Silicone 7 Replace Pump Motor See Chapter 5 Pump Motor Removal and Installation 8 Replace Valve Moto...

Page 107: ...een Output Temp Thermocouple j FLUID OUT audible alarm l Temp when Over Temp alarm on screen m Temp when Over Temp alarm Thermocouple if OK if OK if OK if OK if OK 37 5 2 C 37 5 2 C if OK 42 to 45 C 1 to 2 C of screen 3 Battery Run Time test 30 min 4 Electrical Safety Check See attached Results Sheet a Earth Leakage Current b Patient Leakage Current if OK 5 Hardware verification iii Valve Operatio...

Page 108: ...Ground O Unit in STANDBY Neutral NORM Neutral OPEN Unit in ON not pumping Neutral NORM Neutral OPEN Unit in ON infusing 500 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 109: ...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 E...

Page 110: ...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 111: ...tructions on the screen Operational alarms that may occur in the course of a procedure are Air Detection Door Open Fluid Out High Pressure Low Battery Missing Disposable Heating Alarms Heating Fault Over Temperature Hardware Alarms Air Detector Fault Heater Fault Latch Heater Power Read Back Fault Heater Over Power Fault Power Module Overtemp Pump Fault Valve Fault Watch Dog Other Operational Diff...

Page 112: ...d heating to stop The Air Detection alarm figure 1 and message will appear The valve goes to the recirculate position Figure 1 Air Detection alarm Press MUTE to silence the alarm Check for air in the line Clear the air by removing the tubing from the air detector Squeeze or tap the section of the tubing right below the air detector to clear any air bubbles trapped in the air detector back into the...

Page 113: ...E to recirculate the fluid and remove air in the main system If the system does not complete the Reprime procedure because the hydrophobic filter on top of the reservoir chamber is clogged by blood particulates see the previous section on how to complete the Reprime The system will resume infusion upon completion of the Reprime ...

Page 114: ...e tubing The error message will clear when the door is closed Figure 3 Door Open alarm If the disposable needs to be removed from the system press and hold the OPEN VALVE to release the tubing The valve will remain open and an audible alarm will sound while the key is pressed Make certain the patient line is clamped shut to prevent uncontrolled fluid flow CAUTION While the open valve key is presse...

Page 115: ...rculate position Figure 4 Fluid Out Alarm Figure 5 Fluid Out alarm after pressing REPRIME Press MUTE to silence the alarm Clamp off the empty bags and bag spikes and replace with new fluid bags Pierce new bags and unclamp bag spikes Open the door to let fluid into the reservoir before press REPRIME The system will automatically stop and return to the Infuse screen after Reprime Detection of air du...

Page 116: ...the reservoir chamber stays empty after a Reprime the hydrophobic air vent filter on top of the reservoir chamber may be clogged by blood particulates Under this condition air in the reservoir chamber can be forced back into the fluid bag by using procedure below Pierce both bag spikes into separate fluid bags and open both clamps to allow the air in the reservoir chamber to escape into one of the...

Page 117: ...ystem and replace the disposable set and proceed with the original prime Check to make sure that the disposable set is properly installed and the pump tubing is not stretched CAUTION High amounts of particulates in the blood may clog the bag filter and or coarse blood filter inside the reservoir chamber Replace bag filter reservoir chamber and or disposable set if filter s becomes clogged If it be...

Page 118: ... Open the luer connectors and disconnect the reservoir chamber Using aseptic techniques reconnect lines with a new chamber to continue Take care not to kink or twist the lines If fluid is spilled onto the Fluid Out detector clean and dry the detector and tubing before continuing CAUTION For proper operation keep the fluid out detector and pump tubing clean and dry ...

Page 119: ... that the infusion site is well placed and not blocked If the recirculate line is indicated check that the recirculation line is not obstructed Use the appropriate infusion set recommended in the guide Match the Infusion Set to Flow Rate and Fluid Type in Chapter 3 Check pressure limit setting in SERVICE MODE to make certain that it is set appropriately Use higher pressure limit when possible to a...

Page 120: ...to an AC outlet to continue operation and charge the battery e The normal recharge time is 8 hours 6 MISSING DISPOSABLE Figure 8 Missing Disposable set alarm In AC operation the system will check for the presence of a disposable set before the Prime screen at startup and every time the door is opened and closed Install the disposable set and close the door to remove the alarm U ...

Page 121: ...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 air remaining within the air detector Check the air detector and make certain that it is clean and nothing is obstructing the sensor Reseat the tubing in the air detector and make certain that it is seated firmly in ...

Page 122: ...REPRIME If the Re prime volume count does not count down from 100 to 0 ml then Check that bags are fully spiked and clamps are fully opened The reservoir chamber should be seated in the holder Check that the pump head tubing is not stretched and is seated firmly within the fluid out sensor Check the fluid out sensor and make certain it is clean and there is nothing obstructing contact with the sen...

Page 123: ...imit setting Press NEXT to silence the alarm and resume Check functionality of the pressure transducer by gently pressing the transducer Pressure reading on screen should change If not it is defective LOW BATTERY Battery voltage is too low less than 22 5 0 3 volts Flash LOW BATTERY message and sound periodic beep Plug the system into an AC outlet to continue operation and recharge the battery Allo...

Page 124: ...TURE 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 42ΕC Temperature probes are wet dirty or blocked Restricted flow or out of fluid Stop pumping and heating Sound alarm and display message Valve in the recirculate position Check disposable set and flow path for occlusi...

Page 125: ...d service machine if error persists replace Power Driver Module HEATER POWER READ BACK FAULT HEATER POWER I O FAULT RESTART SYSTEM AND RETRY SERVICE MACHINE IF ERROR PERSISTS Heater power feedback sense coil open Power feedback circuit malfunction Stop pumping and heating Sound alarm and display message Valve in the recirculate position Restart the system and try again Power down and service machi...

Page 126: ...CKAGE RESTART SYSTEM OR PRESS RETRY SERVICE MACHINE IF ERROR PERSISTS Pump failure Pump speed feedback encoder failure Pump runs out of control or does not move when requested Stop pumping and heating Sound alarm and display message Valve to the recirculate position Check that pump turns freely and head is clean Pump tubing is seated properly on the roller pump Press Retry to try again Power down ...

Page 127: ...ardware override circuit detects processor not operating properly Stop pumping and heating Sounds a high pitch tone Restart the system service machine if error persists replace Computer board CAUTION In a Watch Dog alarm condition and fluid in the disposable set keep the patient line clamped closed when opening the door to prevent uncontrolled fluid flow ...

Page 128: ... system is keeping the pressure in the line under the Pressure Limit by reducing the infusion rate Pressure reading flashes at Pressure Status Line and system periodically beeps Check and remove kinks or obstructions in the tubing Use the appropriate infusion set recommended in the guide Match the Infusion Set to Flow Rate and Fluid Type in Chapter 3 Increase flow by increasing the Pressure Limit ...

Page 129: ...ing too loud Roller pump is hitting the door or pump tubing is not properly installed NA 1 Open the door and reinsert the pump tubing 2 Check to make sure that there is no blood or debris around the door hinges caused the door to lift up resulting in the roller pump hitting the door hub System does not heat to physiologic temperature Windows on the disposable or IR sensor is wet or dirty Power mod...

Page 130: ...mperature used for calibration NA Check the temperature of fluid and make certain it is correct If problem persists service machine replace temperature probe Unable to turn the system power to OFF Q11 on the Daughter board shorted Unplug from the wall outlet not turning off Run in the battery mode until shut down Service machine if problem persists replace the Daughter board ...

Page 131: ...nt replacement is not recommended on these boards Board exchange or replacement is the most efficient method of repair Circuit boards returned for exchange that show evidence of improper repair and are damaged are not considered for exchange Damaged boards will be charged at full price Replacement circuit boards and assemblies are listed below Current parts prices and exchange charges can be deter...

Page 132: ... PCB 402 00034 for 903 00001 903 00001A Daughter PCB 402 00034HP for 903 00023 903 00024 K Driver PCB A or B 402 00035 Heater Control PCB 402 00036 L EMI Filter PCB 402 00015 M EPROM ICU 108 108 00089 N Fan Guard 399 00033 O Fluid Out Sensor 310 00023 P IEC Connector 401 00143 for 120V unit Power Entry Module 401 00142 for 230V unit Q Input Temperature Probe 403 00158 R Membrane Panel 202 00060 S ...

Page 133: ...e FMS2000 call or write the following Belmont Instrument LLC 780 Boston Road Billerica MA 01821 USA 866 663 0212 US Canada 978 663 0212 Worldwide NOTES Belmont Instrument LLC maintains a policy of continuous product improvement and reserves the right to change materials specifications and prices without notice ...

Page 134: ...Manual should be attempted Any unauthorized repairs will immediately void the remainder of the warranty No agent employee or representative of Belmont Instrument LLC has any authority to bind Belmont Instrument LLC to any affirmation representation or warranty concerning its products and any affirmation representation or warranty made by any agent employee or representative shall not be enforceabl...

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