Belmont Medical Technologies HYPERTHERMIA PUMP User manual

OPERATOR’S MANUAL
HYPERTHERMIA PUMP
™

HYPERTHERMIA PUMP™
OPERATOR’S MANUAL
780 BOSTON ROAD
BILLERICA, MA 01821, USA
T: 866.663.0212
F: 78.663.0214
TECHNICAL SUPPORT
USA: 855.3 7.4547
WORLDWIDE: +1. 78.663.0212
[e-mail]
WWW.BELMONTMEDTECH.COM
All service calls & questions should be directed to:
USA: 855.397.4547
Worldwide: +1.978.663.0212
CAUTION: Federal law (USA) restri ts this devi e to sale by
or on the order of a physi ian.
P/N 705-00058 Rev. Y

i
Hyperthermia Pump
™
Operator’s Manual
Table of Contents
Page No.
Chapter 1: Introduction – System Overview
Introduction ..................................................................................................................1-1
Indications for Use........................................................................................................1-1
Contraindications..........................................................................................................1-1
Overview of the Hyperthermia Pump
™
..........................................................................1-2
Control Panel: Display and Keys ..................................................................................1-4
Vacuum Regulator........................................................................................................1-4
Ordering Information.................................................................................................... 1-5
Chapter 2: Operation
Introduction ..................................................................................................................2-1
Step-by-Step Operating Procedures.............................................................................2-2
IV Pole Mounting...............................................................................................2-2
Inspect the System–4.4Liter Reservoir with Straight Inflow/Outflow ..................2-3
Inspect the System–4.4Liter Reservoir with Straight Inflow/Bifurcated Outflow .2-3
Inspect the System–4.4Liter Reservoir with two-Inflow and two-Outflow
Patient Line Option ...........................................................................................2-3
Installing the Disposable Set.............................................................................2-4
Install 4.4 Liter Reservoir with Straight Inflow/Outflow Patient Line ...................2-5
Install 4.4 Liter Reservoir with Straight Inflow/ Bifurcated Outflow Patient Line .2-6
Install 4.4 Liter Reservoir and the Straight Inflow/Outflow with (2) Sumps and (2)
Viaguards Patient Line.....................................................................2-7
Powering on the System ...................................................................................2-8
Installing Fluid Bag............................................................................................2-9
Priming the Main System ..................................................................................2-9
Priming the Patient Line ............................................................................2-10
Connect External Temperature Probes ...........................................................2-10
Connect to Patient ..........................................................................................2-10
Initiating Hyperthermic Lavage........................................................................2-11
Maintain Hyperthermic Lavage........................................................................2-12

ii
Page No.
Pressure Control .......................................................................................2-13
Vacuum Control ........................................................................................2-13
Automatic Air Purging ...............................................................................2-13
End of Procedure............................................................................................2-13
Accidental Power Off ......................................................................................2-14
Battery Operation Screen................................................................................2-14
CHAPTER 3: ALARMS AND TROUBLESHOOTING GUIDE
Introduction ..................................................................................................................3-1
A. Operational Alarms ..................................................................................................3-1
Air Detection .....................................................................................................3-1
Door Open ........................................................................................................3-2
Fluid Out ...........................................................................................................3-2
High Pressure ...................................................................................................3-3
Missing Disposable ...........................................................................................3-3
B. Heating Alarms ........................................................................................................3-4
System Error #101 (Heating Fault)....................................................................3-4
System Error #102 (Over Temperature)............................................................3-4
C. Hardware Alarms .....................................................................................................3-5
System Error #201 (Air Detector Fault) .............................................................3-5
System Error #202 (Fluid Out Detector Fault) ...................................................3-5
System Error #203 (Heater Fault Latch)............................................................3-5
System Error #204 (Heater Power Read Back Fault) ........................................3-5
System Error #205 (Heater Over Power Fault)..................................................3-5
System Error #206 (Power Module Overtemp)..................................................3-5
System Error #207 (Pump Fault).......................................................................3-6
System Error #208 (Valve Fault).......................................................................3-6
System Error #209 (Board Overheat)................................................................3-6
System Error #210 (Internal Computer Malfunction) .........................................3-6
Troubleshooting Other Operational Difficulties..............................................................3-7
CHAPTER 4: PARAMETERS SETTING AND PREVENTIVE MAINTENANCE
Introduction ..............................................................................................................4-1
A. System Setup...........................................................................................................4-2
1. Date/Time ...................................................................................................4-3
2. Display Brightness ......................................................................................4-4
3. Language Setup..........................................................................................4-4
4. Key Rate .....................................................................................................4-4
5. Pressure Limit .............................................................................................4-4

iii
Page No.
B. Service and Preventive Maintenance Schedule .......................................................4-5
Schedule 1........................................................................................................4-5
Schedule 2........................................................................................................4-5
C. Routine Maintenance ...............................................................................................4-6
1. Clean and/or Disinfect Exterior..............................................................4-6
2. Fluid Out and In-Line Air Detectors........................................................4-6
3. Power Cord ...........................................................................................4-6
4. Temperature Probes .............................................................................4-6
5. Fan Guards ...........................................................................................4-6
6. Vacuum Trap.........................................................................................4-6
7. Seals .....................................................................................................4-7
8. Instrument Door and Ceramic Disks ......................................................4-7
9. Rubber Feet ..........................................................................................4-7
D. Testing the System and Operational Check-Out ......................................................4-8
1. Visual Inspection ...................................................................................4-8
2. System Operational Checkout...............................................................4-9
3. Electrical Safety Test - Leakage Current .............................................4-10
4. Hardware Verification ..........................................................................4-12
5. Clean the Pump Head .........................................................................4-17
E. Checklist ................................................................................................................4-18
F. Electromagnetic Compatibility ................................................................................4-20
G. Fuse ......................................................................................................................4-22
H. Calling for Service..................................................................................................4-22
CHAPTER 5: TECHNICAL SPECIFICATIONS
Dimensions ..................................................................................................................5-1
Portability .....................................................................................................................5-1
Power AC .....................................................................................................................5-1
Battery..........................................................................................................................5-1
Environmental ..............................................................................................................5-2
Operating Parameters ..................................................................................................5-2
Operating Panel ...........................................................................................................5-2
Safety and Monitoring...................................................................................................5-3
Alarm States and Controls............................................................................................5-3
Classifications ..............................................................................................................5-4
Symbols and Definitions ...............................................................................................5-5

Chapter 1: System Overview
1-1
The system must be operated by knowledgeable users.
It is essential that you read and understand this
manual before operating the system.
The Hyperthermia Pump
™
is used in therapeutic procedures to raise the temperature of
the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging
the cavity with warmed sterile solution. The warmed sterile solution is pumped into a body
cavity, withdrawn, reheated, and recirculated back to the body cavity for a period of time
specified by the physician.
The system monitors sterile solution temperature, line pressure, and air in the fluid path
to ensure safe operation and alarms at all unsafe conditions. A total of four (4) sterile
temperature probes are supplied as part of Hyperthermia Pump™ Procedure Kit (REF
902-00045). Two (2) of the temperature probes are fixed within the fluid path line to
accurately monitor the temperature of fluid input and output. The other two (2) temperature
probes are supplied as part of the Hyperthermia Pump™ Procedure Kit, (REF 902-00045)
for optional use with the location to be determined by the physician. The use of
temperature probes is optional. Temperature probes do not interface with the unit’s
control system, their purpose is to provide data for display only.
A touch screen displays flow rate, total fluid pumped, output temperature, patient
temperature (4 locations), 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 hardware override circuit
prevents unsafe operation in case of system computer failure. A vacuum regulator is
provided to allow regulation of the fluid levels of the large reservoir and in turn regulates
fluid levels in the patient body.
A battery backup ensures uninterrupted operation, for a very short period of time, when
the AC power is disconnected. An audible alarm sounds, after 10 seconds, to alert the
user that the system is in battery operation and action is required. If the AC power is not
restored, the system shuts down after 90 seconds. There is no heat in battery operation.
Disclaimer: Proper surgical procedures and techniques are the responsibility of the
medical profession. The described procedure is furnished for information purposes only.
Each surgeon must evaluate the appropriateness of the procedure being used based on
their own medical training and experience and the type of surgical procedure being
performed.
INDICATIONS FOR USE
 To raise the temperature of the thoracic or peritoneal cavity to the desired target
temperature by continuously lavaging the cavity with circulating warmed sterile
solution, according to a protocol to be selected by the physician.
CONTRAINDICATIONS
 The Hyperthermia Pump
™
is not for use in warming blood, or blood components,
or blood products for the purpose of transfusion.

Chapter 1: System Overview
1-2
OVERVIEW OF THE HYPERTHERMIA PUMP
™
The complete system consists of the Control System, which is mounted on an IV pole,
and the System Disposable Set. The Hyperthermia Pump
™
can be used only with the
supplied disposables. The Disposable Set is preconnected and has a sterile fluid path. It
is intended for single patient use only.
System Diagram Showing Main Components with Two-
Inflow and Two-Outflow Patient Line
Major components of the Control System
(shown with Two-Inflow and Two-Outflow
Patient Line):
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,
labeled as Tpump as it exits the Heat
Exchanger. Tpump is adjustable,
through the touch screen, from 37º to
48ºC.
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
perfusion mode and closes off the
perfusion line when the system is in
the recirculation mode. It immediately
closes the perfusion 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.

Chapter 1: System Overview
1-3
Three (3) disposable set options are available: Single Reservoir with Straight Inflow/Outflow
(page 3), Single Reservoir with Straight Inflow/Bifurcated Outflow Patient Line (page 3), and
Single Reservoir with two-Inflow and two-Outflow Patient Line (page 2).
Single Reservoir, 4.4 Liter, with Straight Inflow/Straight Outflow Patient Line
Single Reservoir, 4.4 Liter, with Straight Inflow/Bifurcated Outflow Patient Line
CONTROL PANEL: DISPLAY AND KEYS
The control panel consists of the touch screen display, which incorporates a bright

Chapter 1: System Overview
1-4
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, in liter
• Heated Fluid Temperature, Tpump, in ºC
• Patient Temperature, T1, in ºC
• Patient Temperature, T2, in ºC
• Patient Temperature, T3, in ºC
• Patient Temperature, T4, in ºC
• Pressure in the Fluid Line in mmHg
• Target Temperature ▲in ºC
• Target Temperature ▼in ºC
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 for ‘Key Rate’ sensitivity setup.
Alarm Display: Graphical alarm messages indicating where errors have occurred and
suggested operator action.
VACUUM REGULATOR
Display: 0 to -160 mmHg Analog gauge
Control: Multi-turn knob

Chapter 1: System Overview
1-5
ORDERING INFORMATION
Hyperthermia Pump
™
REF: 902-00001, 120 volt
(Pump plus accessory)
Hyperthermia Pump
™
REF: 902-00001A, 230 volt
(Pump plus accessory)
Accessory Kit for Single Reservoir with Straight and Bifurcated Outflow Patient
Line REF: 902-00013
Disposable Set Kit for 4.4 Liter Reservoir with Straight Inflow/Outflow Patient Line
REF: 902-00037 consists of:
•(1 set) Heat Exchanger REF: 902-00006P
•(1 set) 4.4 Liter Reservoir REF: 902-00034P
•(1 set) Straight Outflow Patient Line REF: 902-00039P
Disposable Set Kit for 4.4 Liter Reservoir with Straight Inflow/Bifurcated Outflow
Patient Line REF: 902-00038 consists of:
•(1 set) Heat Exchanger REF: 902-00006P
•(1 set) 4.4 Liter Reservoir REF: 902-00034P
•(1 set) Straight Inflow/Bifurcated Outflow Patient Line REF: 902-00040P
Disposable Set Kit for 4.4 Liter Reservoir with two-Inflow and two-Outflow Patient
Line, the Hyperthermia Pump
™
Procedure Kit,
REF: 902-00045 consists of:
•(1 set) Heat Exchanger REF: 902-00006P
•(1 set) 4.4 Liter Reservoir REF: 902-00034P
•(1 set) Patient Line with Cannula & Temperature REF: 902-00048P
Temperature Probes
To order parts for the Hyperthermia Pump
™
, call or write to the following:
Belmont Medical Technologies
780 Boston Road
Billerica, MA 01821, USA
www.belmontmedtech.com
USA: 855.397.4547
Worldwide: +1.978.663.0212

Chapter 2: Operation
2-1
OPERATION
This chapter explains the procedure for setting up and initiating safe and effective
operation of the Hyperthermia Pump
™
. To change screens’ language, select language at
start-up or go to Chapter 4 “LANGUAGE SETUP” to setup your preferred language.
Do not use this product in the presence of flammable anesthetics.
To avoid risk of electric shock, this device must only be connected to a
supply mains with protective earth.
Do not use with pressure infusers or “bag squeezers”. The system
pump provides adequate pressure to infuse fluid.
The Hyperthermia Pump
™
is not for use in warming blood, or blood
components, or blood products for the purpose of transfusion.
The Hyperthermia Pump
™
has not been evaluated for the delivery of
chemotherapeutic agents.
Immediately wipe any spills from device
.

Chapter 2: Operation
2-2
STEP
-
BY
-
STEP SUMMARY OF OPERATING PROCEDURES
INITIAL SET
-
UP
IV POLE MOUNTING
Use the supplied IV Pole: 5-wheel, maximum
diameter 1 ¼”
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 12" to 18” above the IV pole
base.
While holding clamp closed, loosen the screw to
open up the clamp. Install clamp on the IV pole,
holding clamp closed 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, just 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 Holder onto the IV pole
approximately 9" above the Hyperthermia Pump
™
.
4. Clamp the Vacuum Trap Holder a few inches above
the Reservoir Holder.
If the Vacuum Regulator, REF 403-00341, is used,
screw the trap into the regulator then clamp this
assembly a few inches above the Reservoir Holder.
Make certain that there is nothing obstructing the
air vents at the bottom of the system.
Pole Clamp
Release Handle
12”
–
18 “(30
–
46 cm)
IV POLE
SUPPORT
CLAMP
PLASTIC
WASHER

Chapter 2: Operation
2-3
INSPECT THE SYSTEM
Inspect the system to ensure that you have
all necessary components.
External Temperature probes, not supplied
in base unit. Make sure you have them, if
needed.
(4) Interface cables, supplied, are
compatible with a variety of temperature
sensor probes, i.e. Measurement Specialties
Model 4491 disposable General Purpose
Temperature Probe or DeRoyal REF 81-
020409.
For 4.4 Liter Reservoir with Straight Outflow Kit, REF
902-00037:
(1) Power cord. Use only the supplied power cord.
(4) External Temperature Interface Cables
(1) Heat Exchanger, REF 902-00006P
(1) 4.4 Liter Reservoir, REF 902-00034P, contains
o(1) tubing with bag spike
o(1) tubing with medication port
o(1) Vacuum source tubing with filter
(1) 16 ft. Patient Line Set, REF 902-00039P
(1) Reservoir Holder, REF 403-00252
(1) Vacuum Regulator Assembly, REF 403-00341
Hospital supplied vacuum source capable of
reaching -160 mmHg
4.4 Liter Reservoir with Straight
Inflow/Bifurcated Outflow Option
For 4.4 Liter Reservoir with Straight Inflow/Bifurcated
Outflow Kit, REF 902-00038:
(1) Power cord. Use only the supplied power cord.
(4) External Temperature Interface Cables
(1) Heat Exchanger, REF 902-00006P
(1) 4.4 Liter Reservoir, REF 902-00034P
o(1) tubing with bag spike
o(1) tubing with medication port
o(1) Vacuum source tubing with filter
(1) Patient Line Set, REF 902-00040P, contains
o(1) 8 ft. Patient Line with straight inflow
o(1) 8 ft. bifurcated outflow
(1) Reservoir Holder, REF 403-00252
(1) Vacuum Regulator Assembly, REF 403-00341
Hospital supplied vacuum source capable of
reaching -160 mmHg
4.4 Liter Reservoir with two-Inflow and
two-Outflow Patient Line Option
For Hyperthermia Pump
™
Procedure Kit, REF 902-
00045
(1) Power cord. Use only the supplied power cord.
(4) External Temperature Interface Cables
(1) Heat Exchanger, REF 902-00006P
(1) 4.4 Liter Reservoir, REF 902-00034P
o(1) tubing with bag spike
o(1) tubing with medication port
o(1) Vacuum source tubing with filter
(1) Procedure Kit, REF 902-00048P, contains
o(1) Multi-bore Patient Line with straight
inflow/outflow and (2) temperature probes
o(1) Y-connection with (2) Sumps
o(1) Y-connection with (2) Viaguards
o(2) Temperature Probes
(1) Reservoir Holder, REF 403-00252
(1) Vacuum Regulator Assembly, REF 403-00341
Hospital supplied vacuum source capable of reaching
-160 mmHg

Chapter 2: Operation
2-4
INSTALLING DISPOSABLE SET
Heat Exchanger with key components
The disposable set is for single patient
use only. Do not reuse.
DO NOT USE disposable set if package
has been damaged or opened
Store the disposable set in a dry well-
ventilated area free from exposure to
chemical vapors. Always apply first-in,
first-out technique to minimize the length
of storage of the sets.
1. Open the door. Insert Heat
Exchanger with red arrow
pointing up (Red tinted
tubing to red stripe on
unit.)
2. Firmly position the Interlock
Block into the fluid out
detector.
3. Guide the curved piece of
pump tubing (Blue tinted
tubing) over the pump
head. Check that the thinner
Recirculate Line (3/16” O.D
tubing) is in the groove to
the right.
Do not kink or twist the
tubing
4. Place the Pressure
Chamber into the pressure
chamber well. Firmly insert
the wider Perfusion Line
(3/8” O.D tubing) 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 if the pressure
transducer is damaged.
5. Place the thinner Recirculate Line (3/16” O.D tubing)
to the right of the air detector, and to the right of the
valve wand.
6. Close and latch the door. Make certain the pump
tubing is not pinched.

Chapter 2: Operation
2-5
INSTALL 4.4 LITER RESERVOIR AND THE
STRAIGHT INFLOW/OUTFLOW PATIENT
LINE
Straight Inflow/Outflow Patient Line
Configuration with 4.4 Liter Reservoir, Heat
Exchanger and Vacuum Regulator
Reservoir Top View
4.4 Liter Reservoir with Straight
Inflow/Outflow Patient Line Version
1. Place the reservoir into the holder.
2. Assemble the reservoir, using aseptic
techniques, as follows:
Top of Reservoir: Remove all vented caps from
top of reservoir and install these parts to the
marked locations:
Bag Spike for STERILE SOLUTION
Tubing with injection port to LUER
Regulator source tubing from the vacuum
trap to VACUUM
3. Using aseptic technique, connect the Reservoir
outlet, 3/8” O.D tubing, and the Recirculation
Line, 3/16” O.D tubing, to the connectors of the
Heat Exchanger.
4. Adjust the Reservoir Holder to make sure that the
two connection leads underneath the reservoir
are not stretched or kinked.
Stretched or kinked connection leads can cause
flow restrictions.
5. Close all clamps and the ON/OFF pinch clamps.
INSTALLING PATIENT RETURN LINE
1. Hand off the 16 ft. Patient Return Line to the
sterile field.
2. Receive both ends of the Patient Return Line
from the sterile field.
3. Connect LUER end of the Patient Return Line to
the LUER lock on the Heat Exchanger. Observe
directional ARROW imprinted on the patient line.
4. Connect one “Y-Connection” end of the Patient
Line to top of the reservoir, marked PATIENT
RETURN. The other end is used to remove
waste at the end of the procedure. MAKE SURE
THE ON/OFF PINCH CLAMP ON THIS LINE IS
PINCHED CLOSED.

Chapter 2: Operation
2-6
INSTALL 4.4 LITER RESERVOIR AND THE
STRAIGHT INFLOW/ BIFURCATED OUTFLOW
PATIENT LINE
Straight Inflow/Outflow Patient Line Configuration
with 4.4 Liter Reservoir, Heat Exchanger and
Vacuum Regulator
Reservoir Top View
4.4 Liter Reservoir with Straight Inflow/
Bifurcated Outflow Patient Line Version
1. Place the reservoir into the holder.
2. Assemble the reservoir, using aseptic
techniques, as follows:
Top of Reservoir: Remove all vented caps from
top of reservoir and install these parts to the
marked locations:
Bag Spike for STERILE SOLUTION
Tubing with injection port to LUER
Regulator source tubing from the vacuum
trap to VACUUM
3. Using aseptic technique, connect the Reservoir
outlet, 3/8” O.D tubing, and the Recirculation
Line, 3/16” O.D tubing, to the connectors of the
Heat Exchanger.
4. Adjust the Reservoir Holder to make sure that
the two connection leads underneath the
reservoir are not stretched or kinked.
Stretched or kinked connection leads can cause
flow restrictions.
5. Close all clamps and the ON/OFF pinch clamps.
INSTALLING PATIENT RETURN LINE
1. Hand 8 ft. Patient Line and the 8 ft. Bifurcated
Patient Line to the sterile field.
2. Receive both ends of the Patient Return Line
from the sterile field.
3. Connect LUER end of the Patient Return Line
to the LUER lock on the Heat Exchanger.
Observe directional ARROW imprinted on the
patient line.
4. Receive the “Y-Connection” end of the
Bifurcated Outflow Patient Line from the sterile
field and connect one end to top of the
reservoir, marked PATIENT RETURN. The
other end is used to remove waste at the end of
the procedure. MAKE SURE THE ON/OFF
PINCH CLAMP ON THIS LINE IS PINCHED
CLOSED.

Chapter 2: Operation
2-7
INSTALL 4.4 LITER RESERVOIR AND THE
STRAIGHT INFLOW/OUTFLOW WITH (2)
SUMPS AND (2) VIAGUARDS PATIENT LINE
Two Inflow/Two Outflow with (2) internal
Temperature Probes
Reservoir Top View
The Hyperthermia Pump
™
Procedure Kit
1. Place the reservoir into the holder.
2. Assemble the reservoir, using aseptic
techniques, as follows:
Top of Reservoir: Remove all vented caps from
top of reservoir and install these parts to the
marked locations:
Bag Spike for STERILE SOLUTION
Tubing with injection port to LUER
Regulator source tubing from the vacuum
trap to VACUUM
3. Using aseptic technique, connect the Reservoir
outlet, 3/8” O.D tubing, and the Recirculation
Line, 3/16” O.D tubing, to the connectors of the
Heat Exchanger.
4. Adjust the Reservoir Holder to make sure that
the two connection leads underneath the
reservoir are not stretched or kinked.
Stretched or kinked connection leads can cause
flow restrictions.
5. Close all clamps and the ON/OFF pinch clamps.
INSTALLING PATIENT RETURN LINE
1. Hand off the Procedure Kit to the sterile field.
2. Receive both ends of the Patient Return Line
from the sterile field.
3. Connect LUER end of the Patient Return Line
to the LUER lock on the Heat Exchanger.
Observe directional ARROW imprinted on the
patient line.
4. Connect one “Y-Connection” end of the Patient
Line to top of the reservoir, marked PATIENT
RETURN. The other end is used to remove
waste at the end of the procedure. MAKE
SURE THE ON/OFF PINCH CLAMP ON THIS
LINE IS PINCHED CLOSED.

Chapter 2: Operation
2-8
POWER ON
Check that the detachable power cable is
securely seated in the main power
receptacle.
Ensure that circuit breaker is easily
accessible to turn off in an emergency
situation.
Plug the system power cord into a
grounded, 3-prong, 20 Amp, AC receptacle.
Do not use an adaptor for ungrounded
outlets.
Plug the external temperature interface
cables to the Hyperthermia Pump
™
, labeled
T1, T2, T3 and T4, as needed.
Power-Up Screen
with blue arrow
4. Place tubing matching color
5. Insert Pressure Chamber
6. Place tubing matching colored
lines, close and latch door
NEXT
Installation Screen
1. Turn power on by firmly pressing the circuit
breaker to the ON position. The system will
perform a self-check to check the integrity of
system parameters.
Statement “For Hyperthermic
Treatment Only. Not for infusion into
the circulatory system” appears on
screen.
Check the power cord and AC receptacle
connections if the statement does not
appear.
If “Agree” is pressed, the screen will
display “Password” screen. Enter a
factory default password, 111111.
NOTE: If “Disagree” is pressed, “Turn
power off, procedure ended” will
display.
If you want to change the password
(P.W), press “Change P. Word” and enter
the old P.W. Enter the new P.W and then
confirm the password by entering the new
password.
2. Belmont Logo with software revision and
checksum appear.
3. PRIME screen will appear.
4. Press NEXT to go to the PRIME screen.
• If screen language is not your preferred
language, turn power off and back on.
• Press SERVICE to go to
CALIBRATION/SETUP screen.
• Press LANG SETUP →choose your
preferred language →NEXT →EXIT
SERVICE.
• If you turn power ON without the
disposable set, INSTALLATION screen
appears.
• Open the door and follow instructions
on screen to install the disposable set.
• Close the door. PRIME screen will
automatically appear.
For Hyperthermic Treatment
Only. Not for infusion into
the circulatory System.
AGREE DIS-
AGREE

Chapter 2: Operation
2-9
INSTALLING FLUID BAG AND PRIME
Sterile normal saline, peritoneal dialysis
solution, or other crystalloid solution per
physician order.
Prime Screen
1. Hang (1) 2-liter sterile fluid bag on the IV pole.
2. Completely close bag clamps, remove the bag
spike cap on the line closest to the user.
Spike fluid bag, pierce it fully to ensure that
fluids flow freely.
3. Open the clamps, on the line that pierced the
sterile solution, and on reservoirs outlets (for
Dual Reservoir version).
4. Drop sufficient volume to prime the entire
system, approximately 500 ml.
PRIME THE MAIN SYSTEM
System Priming Screen
CAUTION:
Immediately wipe any spills from the device
5. Press PRIME to recirculate 100 ml of fluid at
500 ml/min to remove air and fill the main
system with fluid. The prime volume, 100 ml,
countdown is displayed on the screen. The
pump will stop automatically when countdown
reaches 0 ml.
6. If after 30 seconds and the prime volume
remains at 100 ml, the system will stop, alarm
and instruct the user to unclamp the lines and
resume prime.
7. If PRIME has to be stopped, press STOP. The
prime volume countdown will remain on the
screen. Press RESUME PRIME to continue
prime.

Chapter 2: Operation
2-10
PRIME THE PATIENT LINE
System Primed Screen
Patient Line Primed Screen
To remove air from the patient line.
8. Open the clamp, near the LUER end, and the
ON/OFF pinch clamp on the patient line to the
reservoir.
Press PT. LINE PRIME. The system primes at
400 ml/min.
9. Inspect to make sure that no air remains in the
patient line. When air is no longer visible, press
STOP.
10. If there are air bubbles after the diversion
valve, press PT. LINE PRIME again to remove
air.
WARNING!
Before continuing, you must inspect and make
certain that the patient line is completely primed
and free of air and the ON/OFF pinch clamp, on
the waste line, is pinched closed.
CONNECT EXTERNAL TEMPERATURE
PROBES. PROBES ARE SUPPLIED WITH
THE PROCEDURE PACK KIT (REF 902-
00045). IF YOU DO NOT USE THIS KIT (REF
902-00045), MAKE SURE YOU HAVE
PROBES, IF NEEDED.
Accept external temperature connections from the
sterile field and connect to the Hyperthermia
Pump
™
external temperature interface cables.
Connect temperature probes to the corresponding
color jacks on the unit. Push firmly to assure full
contact. Forced mating of the connectors can
cause malfunction and interruption of electrical
continuity.
CONNECT TO THE PATIENT 1. Surgical personnel in sterile field cut the
Patient Return Line to a specified length to
accommodate the INFLOW and RETURN
cannulation, except the Bifurcated Outflow
version.
2. Drop the prescribed solution to the reservoir.
3. Inform surgical team that the prescribed
solution is ready to ensure that only
appropriate personnel are left in the room.