Belmont FMS2000 User manual

OPERATOR’S MANUAL
The Belmont®Rapid Infuser, FMS2000
780 Boston Road
Billerica, MA 01821, USA
866-663-0212 US/Canada
978-663-0212 Worldwide

The Belmont®RAPID INFUSER, FMS2000
OPERATOR’S MANUAL
Belmont Instrument Corporation
780 Boston Road
Billerica, MA 01821, USA
Wellkang Tech Consulting
Suite B, 29 Harley Street
London, W1G 9QR
England, United Kingdom
Tel: [phone]
Fax: [phone]
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

i
The Belmont®Rapid Infuser FMS2000
Operator=s Manual
Table of Contents
Page No.
CHAPTER 1: INTRODUCTION - SYSTEM OVERVIEW
Introduction .........................................................................................................................1
Indications for Use ..............................................................................................................1
Contraindications ................................................................................................................1
Overview of the Belmont®FMS2000 ..................................................................................2
Control Panel: Display and Keys ........................................................................................3
CHAPTER 2: OPERATION
Introduction .........................................................................................................................4
Step-by-Step Operating Procedures...................................................................................5
IV Pole Mounting....................................................................................................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
Recirculation..................................................................................................12
Stop ...............................................................................................................12
Battery Operation..............................................................................................................12
Low Battery....................................................................................................12
Accidental Power Off.........................................................................................................13
End of Procedure..............................................................................................................13
Emergency Manual Operation ..........................................................................................13

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Page No.
CHAPTER 3: ALARMS AND TROUBLESHOOTING GUIDE
Introduction .......................................................................................................................14
A. Operational Alarms ..............................................................................................14
Air Detection..................................................................................................14
Door Open.....................................................................................................15
Fluid Out........................................................................................................15
High Pressure................................................................................................16
Low Battery....................................................................................................16
Missing Disposable........................................................................................16
B. Heating Alarms.....................................................................................................17
Heating Fault .................................................................................................17
Over Temperature.........................................................................................17
C. Hardware Alarms .................................................................................................18
Air Detector Fault...........................................................................................18
Heater Fault Latch.........................................................................................18
Heater Power Read Back Fault.....................................................................18
Heater Over Power Fault...............................................................................18
Power Module 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 Disinfect Exterior....................................................................27
2. Fluid Out and In-Line Air Detectors .............................................................27
3. Power Cord..................................................................................................27
4. Temperature Probes....................................................................................27
5. Fan Guards..................................................................................................27
6. Seals............................................................................................................27
7. Instrument Door and Ceramic Disks............................................................28
8. Rubber Feet.................................................................................................28

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Page No.
D. Testing the System and Operational Check-Out.................................................29
1. Visual Inspection..........................................................................................29
2. System Operational Checkout.....................................................................30
3. Battery Run Time.........................................................................................30
4. Electrical Safety Test - Leakage Current.....................................................31
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

1
It is essential that you read and understand this manual
before operating the system.
The Belmont®Rapid Infuser, FMS2000,warms blood, colloid, and crystalloid to physiologic
temperature at user-set rates from 10 to 750 milliliters per minute (ml/min) with a 1000 ml/min as
an option. 2.5 and 5.0 ml/min (150 and 300ml/hr) are also available to keep the venous line open
but no heating is provided at these rates.
The system monitors temperature, line pressure, and 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 are displayed on
the touch screen.
A battery backup 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 suffering from blood loss due to trauma or surgery.
Infusion of warmed fluid to re-warm patients after surgery or for hypothermia.
Infusion of warmed fluid for irrigation in urology procedures.
CONTRAINDICATIONS
The system should not be used where the desired flow rate is below 2.5 ml/min or above
1000 ml/min.
The system should not be used to warm platelets, cryo-precipitates, or granulocyte
suspensions.
This system is not intended for drug administration.
The Belmont® FMS2000 should not be used where rapid infusion is medically
contraindicated.
Lactated Ringer’s solution, dextrose in water, and hypotonic sodium chloride solutions
should not be added to blood components (AABB Technical Manual 17th edition, page
624)

2
Fluid Out(1)
Detector
Display(4)
IR (5)
Probe
Air (6)
Detector
Valve (7)
Wand
IR Probe
(8)
Power(2)
Switch
RollerPump
(3)
OVERVIEW OF THE BELMONT FMS2000
The complete system consists of the FMS2000 Control System, which is mounted on an IV pole,
and the FMS2000 Disposable Set. The FMS2000 can be used only with the supplied
disposables. A large volume 3-liter reservoir is available as an optional accessory for
convenience in cases involving very large infusion volumes, see page 7.
The Disposable Set is preconnected and has a sterile fluid path. It is intended for single
patient use only.
System Diagram Showing Main Components
Major components of the Control System:
1. Fluid Out Detector detects and alarms at
an out of fluid situation.
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
immediately to prevent air into the patient.
Pumping and heating stop, alarm sounds
and “Air Detection” message is displayed
on screen.
7. Valve wand closes off the recirculation
line when the system is in the infusion
mode and closes off the infusion line
when the system is in the recirculation
mode. It immediately closes the infusion
line to the patient when an error condition
occurs which may require user
intervention.
8. IR Temperature Probe (Input Probe)
monitors input fluid temperature as it
enters the Heat Exchanger.

3
CONTROL PANEL: DISPLAY AND KEYS
The control panel consists of the touch screen display, which incorporates a bright graphical
display with touch pad keys. The display shows status and alarm messages at the top and
middle, and contains the touch keys at the bottom.
CONTROL PANEL SUMMARY
Status Display:
Flow Rate in ml/min
Volume Infused
Infusate Temperature in ºC
Pressure in the Fluid Line in mm Hg
Bolus 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 the factory to medium, but can be adjusted by the
operator in SERVICE MODE.
See Chapter 4, page 25 for ‘Key Rate’ sensitivity setup.
Alarm Display: Graphical alarm messages indicating where errors have occurred and suggested
operator action.

Chapter 2: Operation
4
OPERATION
This chapter explains the procedure for setting up and initiating safe and effective operation
of the Belmont®Rapid Infuser, FMS2000.
WARNING!
Do not use this product in the presence of flammable anesthetics.
WARNING!
To avoid risk of electric shock, this device must only be connected to a
supply main with protective earth.
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 administration.
WARNING!
Do not mix lactated Ringer’s or other solutions containing calcium with
citrated blood products.
Use only anticoagulated blood products

Chapter 2: Operation
5
STEP-BY-STEP SUMMARY OF OPERATING PROCEDURES
SET-UP
INSPECT THE SYSTEM
Power cord
Reservoir Support
Disposable Set
Large Reservoir and holder, if needed
Inspect the system to ensure that you have all
necessary components.
Use only supplied power cord.
IV POLE MOUNTING
IV Pole: 5 wheel, maximum diameter 1
1/4"
Install the Support Assembly 30" from
the ground, if not already installed.
Mount the FMS2000 on the IV Pole
above the Support Assembly
Install the Reservoir Support app. 9"
above the top of the system
CAUTION:
Check that the system is securely 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 Release Handle” to
open. Mount the system onto the IV pole, above
the support assembly, by pushing down on the
pole clamp release handle. Check that the
system is locked in place before proceeding.
3. Clamp the reservoir support onto the IV pole
approximately 9" above the FMS2000.
Make certain that there is nothing
obstructing the air vents at the bottom of
the system.