Belmont Medical Technologies Hyperthermia Pump 505 User manual

Hyperthermia Pump™
OPERATIONAL CHECK OUT MANUAL
780 BOSTON ROA
BILLERICA, MA 01821, USA
T: 866.663.0212
F: 978.663.0214
TECHNICAL SUPPORT
USA: 855.397.4547
WORL WI E: +1.978.663.0212
TECHSUPPORT@BELMONTME TECH.COM
WWW.BELMONTME TECH.COM

Hyperthermia Pump™
OPERATIONAL CHECK OUT MANUAL
Belmont Medical Technologies
780 Boston Road
Billerica, MA 01821, USA
Emergo Europe BV
Prinsessegracht 20
2514 AP The Hague
The Netherlands
[phone]
All service calls & questions should be directed to
USA: 855.397.4547
Worldwide: +1.978.663.0212
CAUTION: Federal law (USA) restricts this device to be sold by or on the order of a physician.
REF 702-00134/Rev I

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 1 of 20
Hyperthermia Pump
Operational Check Out Manual
Table of Contents
..................................................................................................................Page No
Parameters Setting, Service, and Preventive Maintenance................................................................2
A. System Setup.......................................................................................................................3
1. Date/Time .............................................................................................................4
2. Alarm Volume ......................................................................................................5
3. Display Brightness................................................................................................5
4. Key Rate ...............................................................................................................5
5. Pressure Limit.......................................................................................................5
B. Service and Preventive Maintenance Schedule...................................................................6
Schedule 1...........................................................................................................................6
Schedule 2...........................................................................................................................6
C. Routine Maintenance ..........................................................................................................7
1. Clean and/or Disinfect Exterior ............................................................................7
2. Fluid Out and In-Line Air Detectors.....................................................................7
3. Power Cord ...........................................................................................................7
4. Temperature Probes ..............................................................................................7
5. Fan Guards............................................................................................................7
6. Vacuum Trap ........................................................................................................7
7. Seals......................................................................................................................8
8. Instrument Door and Ceramic Disks.....................................................................8
9. Rubber Feet...........................................................................................................8
D. Testing the System and Operational Check-Out .................................................................9
1. Visual Inspection ..................................................................................................9
2. System Operational Checkout ............................................................................10
3. Electrical Safety Test - Leakage Current ............................................................11
4. Hardware Verification ........................................................................................13
5. Clean the pump head ..........................................................................................18
E. Checklist ...........................................................................................................................19

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 2 of 20
The Hyperthermia Pump requires minimal service and care. Preventive maintenance should be performed
regularly to optimize performance and reduce the likelihood of downtime. Listed below are routine
maintenance (as needed), periodic maintenance (at least once a year), and parameters setting. The instrument
does not need regular calibration.
WARNING!
Practice standard precautions when handling any caustic solution. Clean up all
spills immediately.
WARNING!
Test leakage current routinely to insure against electrical shock hazard.
CAUTION:
Turn the system to STANDBY and unplug the power cord before cleaning to
avoid electric shock.
CAUTION:
Immediately wipe any spills from the device.
PARAMETERS SETTING, SERVICE, AND PREVENTIVE MAINTENANCE

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 3 of 20
A. SYSTEM SETUP
Changes in system setup can be made to:
Date and time: Set the real time clock and date
Audible alarm volume: Set the audible alarm volume level
Display brightness: Change the display brightness
Key Rate: Set touch key sensitivity
Pressure limits for High Pressure alarm: Set the maximum allowable in-line pressure. The possible
setting range from 100 to 300 mmHg.
Parameter Setup changes is performed in the Service mode.
www.belmontMedTech.com
Pressing the SERVICE key accesses the Calibration/Set-up mode. This key appears on the BELMONT logo
screen only at system powered-up. This screen remains active for 4.5 seconds before the system enters the
Prime mode .
For Hyperthermia Treatment
Only. Not for infusion into
the circulatory System.
AGREE DIS-
AGREE
CALIBRATION/SET-UP
TIME 23:59 DATE: 08-29-08
PRESS LIMIT 300mmHg
AC POWER PRESENT
EXIT
SERVICE
DISPLAY
BRIGHT
HARD-
WARE
PRESS
LIMIT
TEMP
CAL
PRESS
CAL
POWER
CAL
MEDIUM
KEYRATE
DATE
TIME
ALARM
VOL SET
Rev
CKSUM
=
AC POWER
PRESENT
SERVICE

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 4 of 20
1. Date/Time
Press DATE TIME in the CALIBRATION/SET-UP screen to set the time and date. Press
either the TIME or DATE key.
Screen after pressing DATE TIME key
A numerical keypad will be displayed. Enter the appropriate time or date information. Enter the
appropriate time in 24-hour clock format (i.e. 1:00 PM = 13:00). CANCEL will erase the entered
value and return to the previous Date Time screen. Press UPDATE to save the new value and return
to the previous DATE TIME key screen. Press NEXT to return to the Calibration/Set-Up screen.
Screen after pressing DATE
Screen after pressing TIME

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 5 of 20
Alarm Volume
ALARM VOL SET is used to set the volume level of the audible alarm. There are seven levels of
alarm volume. Each time the key is pressed, a tone will sound to indicate the present alarm volume
level.
3. Display Brightness
There are nine levels of display brightness. Press DISPLAY BRIGHT to change the present level
of brightness to the next level.
4. Key Rate
The key rate sets up the sensitivity of the touch keys. There are three different levels of sensitivity;
FAST, MEDIUM and SLOW. The current level of sensitivity is indicated on the key itself. The
FAST setting requires the least amount of time for a key to respond. The MEDIUM setting requires
more time and the SLOW key requires the most time and makes the touch keys least sensitive. The
key sensitivity is set at factory to Fast.
Note that this key changes the time required to depress a key for stroke to be recognized. The
pressure required is not affected.
5. Pressure Limit
The user can set the maximum allowable in-line pressure. The possible setting ranges from 100 to
300 mm Hg. The current pressure limit value is displayed on the PRESS LIMIT status line on the
Calibration/Set-Up screen. Press and hold the key to change the limit in increments of 50 mmHg.
During infusion, the system keeps the pressure in the line under the pressure limit by reducing the
infusion rate as the in-line pressure approaches the pressure limit. The pressure limit is
automatically reset to 300 mmHg each time that the system is powered on.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 6 of 20
B. SERVICE AND PREVENTIVE MAINTENANCE SCHEDULE
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/Clean the Vacuum Trap
•
7. Check the System Seal.
•
8. Check Instrument Door and Ceramic Disk.
•
9. Check Rubber Feet.
•
Schedule 2
To be performed by either a BMET or other qualified service personnel.
Required Test/Verification
Interval
Every 6
Months
Every
Year
1. Perform Visual Inspection.
•
2. Perform System Operational Check-Out, including the
Audible Alarm Test.
•
3. Perform Electrical Safety Test.
•
4. Hardware Verification.
•
5. Clean Pump Head
•

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 7 of 20
C. ROUTINE MAINTENANCE
1. Clean and/or Disinfect Exterior
Clean the outside surfaces of the system and inside the door after each use.
a. Turn the pump to STANDBY and unplug the power cord.
b. Wipe the surface with a cloth moistened with water or isopropyl alcohol.
Note: Avoid the use of acetone or other solvents that might damage the surface.
c. Also clean around the door hinges, making sure the door is pushed all the way down
inside the hinges.
d. Do not spray cleaning liquids into or onto the air vents at the bottom of the system.
2. Fluid Out and In-Line Air Detectors
Keep 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.
4. Temperature Probes
Keep the probe sensors clean and dry. If they become dirty or wet, clean with a moistened Q-tip
and dry. Use care not to damage the sensor surface.
5. Fan Guards
Inspect the fan guards, on the bottom of the unit, for debris that might impede air flow. Remove
guards by unscrewing the 4 retaining screws and clean, with soap and water, if necessary. Make
certain the guards are not damaged. Let the fan guards dry before reinstalling.
6. Vacuum trap
Inspect the vacuum trap. If there is contamination, remove the trap by turning the friction nut
counter-clockwise. Clean the interior surfaces using soap and water. Dry and re-assemble.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 8 of 20
7. Seals
Inspect the seal around the unit to make certain it is in good condition. Check also the seal around
the touch screen and ceramic disks. Use Dow Corning 732 multipurpose RTV sealant or equivalent
if needed to maintain fluid resistance.
8. Instrument Door and Ceramic Disks
The instrument door must fit properly for the system to operate correctly. The platen part of the
roller pump is located on the door. The platen must line up properly with the pump.
a. Check hinges for debris build-up, clean any dried debris/fluid from hinges area. Be sure
that door is seated completely down on the hinges.
b. Check plastic rivets and door integrity. Make sure that the door-frame is not bent. Replace,
if bent.
c. Inspect the ceramic disks on the door and in the center of the unit for cracks. Return to
manufacturer for replacement if they are damaged.
9. Rubber Feet
Inspect the rubber feet on the bottom of the unit for cracked or missing rubber feet. Replace if
necessary.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 9 of 20
D. TEST/SYSTEM OPERATIONAL CHECK-
OUT
The device should be serviced periodically, in accordance to schedule 1 and 2, by a qualified technician.
Material Required:
3-Spike Disposable Set, REF 903-00006
Bio-Tek Safety Analyzer or equivalent
Saline or other crystalloid for testing
2 liters of 35-42⁰C fluid
Manometer (2 mm Hg resolution)
Pressure source
Digital Thermometer with thermocouple (0.1⁰C resolution)
Graduated cylinders (ASTM Class B accuracy)
Timer
Tachometer (optional)
Hospital supplied vacuum source or vacuum pump
1. Visual Inspection
a. Door Open/Right Hand Side:
i. Check that air and fluid out detectors are clean.
ii. Check that all the plastic push pins on the door are in-place.
iii. Check that the valve pincher set screw is tight.
iv. Check that there are no cracks in the ferrite on either the door or the right hand
side.
v. Check that the pressure transducer diaphragm has no tears or rips.
vi. Check that each pump roller spins freely. If not, remove and clean.
vii. Check that the door is pushed all the way down and there is no dried debris or
fluid inside or around the hinges.
b. Back:
i. Check that the AC connector (IEC connector) is clean. If there is some saline
residue, clean.
c. Verify Latch/Unlatch Mechanism:
i. Check the rubber pads on the pole clamp assembly. If they feel smooth, clean
and scrub with isopropyl alcohol.
ii. Mount and un-mount the system on an IV pole, verify that the latch and unlatch
work properly and the system will not move down the pole unexpectedly.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 10 of 20
2. System Operational Check-Out
a. Install 3-Spike Disposable set, REF 903-00006.
b. Turn power switch ON and agree to accept full responsibility at start-up sequence. Wait
for PRIME screen to appear.
c. Close bag clamps. Hang and spike fluid bag.
d. Open bag clamp(s). Press PRIME to prime the system (circulate 100 ml of fluid at 500
ml/min.) Prime volume (100 ml) countdown is displayed on screen. Stop automatically
when countdown reaches 0 ml.
e. Press PT. LINE PRIME. Press STOP when line is free of air bubbles.
f. Press PERFUSE to start pumping at 10 ml/min. Press RATE ▲▼ to change flow rate.
g. Remove the power cord. Verify that the system automatically switches to battery when
AC is disconnected. BATTERY NO HEATING message displays to indicate the system
is now in battery mode and heating is suspended. Verify that alarm sounds every 10
seconds. Press MUTE and STOP.
h. Connect back to AC power and verify the operation is uninterrupted. Adjust the flow rate
by pressing PERFUSE RATE ▲▼.
i. Check the vacuum regulator:
i. Connect the vacuum source or the vacuum pump to the regulator inlet (behind the
regulator);
ii. Connect draining tubing to the vacuum trap;
iii. Clamp the drain tube off, adjust the vacuum regulator knob;
iv. Verify that the indicator responds.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 11 of 20
3. Electrical Safety Test - Leakage Current
Equipment required: Fluke Safety Analyzer, Model 505 or equivalent
2 Liters of room temperature saline
Setup: Plug the Hyperthermia Pump into AC outlet on the panel of the Safety
Analyzer.
CAUTION :
Before applying voltage to Safety Analyzer, make sure input line voltage is correct
for the VOLTAGE OF UNIT UNDER TEST.
a. Earth Leakage Currents:
i. Plug the Safety Analyzer into an appropriate power source, turn
Analyzer power to ON. Hyperthermia Pump power switch To
Standby.
ii. Switch selector on Analyzer to CHASSIS or LEAKAGE (µA). Connect
a single red lead to the SINGLE LEAD input jack, and attach large clamp
to equipotential ground terminal on the Hyperthermia Pump .
iii. Record the leakage current displayed for each of the following
conditions, with Neutral switch in NORM position. Tests should be
performed in the following order.
Polarity - NORM; Ground – NORM
Polarity - REVERSE; Ground – NORM
Polarity - REVERSE; Ground – OPEN
Polarity - NORM; Ground - OPEN
iv. Repeat the first two (Normal Polarity and Reverse Polarity - Grounded)
with Neutral switch in OPEN position.
v. Install the disposable set and prime with saline and proceed to the Infuse
screen. Press STOP to set the pump at 0 ml/min, not heating or pumping.
vi. Repeat iii & iv with the Hyperthermia Pump in ON mode (power
switch ON, infuse screen displayed, not pumping or heating).
vii. Repeat iii & iv with the Hyperthermia Pump infusing and heating at 750
ml/min.
viii. All measurements should be <300 A (for Domestic unit) and <500 µA (for
230 V unit).

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 12 of 20
b. 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 or hypodermic needle tip to the end of
patient line and attach the Safety Analyzer large clamp to the cannula or needle tip.
iii. Prime the Hyperthermia Pump with saline. Make sure that the entire patient line
including the cannula has been primed.
iv. Repeat a.iii, and a.iv with the Hyperthermia Pump in the STANDBY, ON, and
pumping at 750 ml/min modes.
v. Maximum leakage allowable is as follows:
With NORMAL NEUTRAL
Normal Polarity - Grounded (10 µA)
Reverse Polarity - Grounded (10 µA)
Reverse Polarity - Not Grounded (50 µA)
Normal Polarity - Not Grounded (50 µA)
With OPEN NEUTRAL (Note: the system automatically switches to battery at 50
ml/min.)
Normal Polarity - Grounded (50 µA)
Reverse Polarity - Grounded (50 µA)

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 13 of 20
4. Hardware Verification
Properly install and prime the 3-Spike disposable set, REF 903-00006, before beginning the Hardware
Verification process.
Hardware mode verifies:
a. Valve operation
b. Fluid Out and Air Detectors
c. Battery voltage.
d. Flow Rate (Pump speed)
e. Input and Output Temperature Probes, and
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.
WARNING!
Do not access hardware verification while the instrument is patient connected.
Press HARDWARE from the Calibration/Set-Up screen.
Enter the Password 013192.
Calibration/Setup Screen
CALIBRATION/SET-UP
TIME 23:59 DATE: 08-29-08
PRESS LIMIT 300mmHg
AC POWER PRESENT
EXIT
SERVICE
DISPLAY
BRIGHT
HARD-
WARE
PRESS
LIMIT
TEMP
CAL
PRESS
CAL
POWER
CAL
MEDIUM
KEYRATE
DATE
TIME
ALARM
VOL SET

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 14 of 20
Hardware Status Screen
Status Line Reading
Pump Speed 0, 10, 100, 500, 750 and 1000 ml/min
Input Temperature Temperature in ⁰C, probe ambient reference in parentheses
Output Temperature Temperature in ⁰C, probe ambient reference in parentheses
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 valve to the right or infuse position.
CANCEL Exit Hardware status and return to the Calibration/Set-Up screen.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 15 of 20
Hardware Verification:
a. Valve
i. Press LEFT VALVE, confirm that the valve wand (valve pincher) moves to the left.
ii. Press OPEN VALVE, confirm that valve wand moves to the middle position.
iii. Press RIGHT VALVE, confirm that the valve wand moves to the right. Leave the valve in
the LEFT VALVE position before continuing to the next step.
b. Fluid Out and Air Detectors
i. Confirm that the Fluid Out Detector and the Air Detector status lines display FLUID when
the system is primed and no air is in the detectors.
ii. Open the door and pull out the tubing from the detectors. Close the door and confirm that
the status line display AIR when the tubing is removed from the sensor.
c. Battery Voltage
Unplug the unit from the wall outlet. ‘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. Make certain the patient line and entire disposable is fully primed before measuring. Set
the pump speed to 10 ml/min. Press RIGHT VALVE to set the valve into the infuse
position and fill the patient line. Use a graduated cylinder to measure flow at the patient
line for ten minutes and verify the average flow rate over that period. The volume collected
should be 100 ± 25 ml for an averaged flow rate of 10 ± 2.5 ml/min.
ii. Press PUMP SPEED again to change the pump speed to 100 ml/min and measure the flow
with a graduated cylinder for one minute. The accepted tolerance is 100 ± 10 ml/min.
iii. Press once more to change speed to 500 ml/min and repeat the measurement. The accepted
tolerance is 500 ± 50 ml/min.
iv. Press once more to change speed to 750 ml/min and repeat the measurement. The accepted
tolerance is 750 ± 50 ml/min.
v. Press once more to change speed to 1000 ml/min and repeat the measurement. The
accepted tolerance is 1000 ± 100 ml/min.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 16 of 20
Measure by using a tachometer:
i. 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%.
ii. Press PUMP SPEED again to change the pump speed to 100 ml/min. The accepted
tolerance is 19.65 rpm ± 10%.
iii. Press once more to change speed to 500 ml/min and repeat the measurement. The accepted
tolerance is 97rpm ± 10%.
e. Input and Output Temperature Probes
Prepare at least 2 liters of 37⁰- 43⁰C fluid
i. Connect the fluid supply to the disposable. Remove the patient line from the luer
connector. Insert the thermocouple approximately 2” into the connector previously
connected to the patient line.
ii. Press the RIGHT VALVE key to set the valve to the infuse position. Open the fluid supply
and set the pump speed to 500 ml/min.
iii. Let the temperature stabilize, wait at least 2 minutes. The INPUT TEMPERATURE and
OUTPUT TEMPERATURE value readings (the values not between the parentheses)
should be within (2⁰C).
iv. Compare the numbers displayed to the thermocouple reading. The accepted tolerance is
1C for fluid temperature between 30⁰C to 40⁰C and 2⁰C outside this range.
v. Press PUMP SPEED to set the pump speed back to 0 ml/min.
vi. Press CANCEL to return to the Calibration/Set-Up screen.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 17 of 20
f. Pressure Transducer
WARNING!
Do not apply excessive pressure to the pressure chamber or pressure transducer. The
pressure transducer is a precision electromechanical device and can be damaged with
excessive force. Do not use the system if the pressure transducer is damaged.
i. Inspect the pressure transducer for damage. Make certain the surface of the
transducer is not cut or punctured. The pressure transducer must be replaced if the
surface is damaged.
ii. Make certain the pressure chamber is properly installed (see Chapter 2: Installing the
Disposable) and the flow path is not blocked.
iii. Make certain the fluid is warm (37⁰- 42⁰C). The pressure chamber of the disposable is less
compliant when it is at room temperature. Verification must be performed with a warm
disposable.
iv. In the Hardware mode: close the door, the bag clamps and block the air vent on top of the
reservoir chamber. Disconnect the patient line and connect the pressure source to the
LUER fitting at the patient line port of the disposable set and apply pressure while
monitoring the amount of pressure with a manometer.
v. Verify the accuracy of the pressure transducer. Apply 300 mm Hg into the disposable.
The pressure status line should read 300 mm Hg (± 50 mmHg). Repeat the same pressure
verification for 200 and 100 mmHg.

Hyperthermia Pump: Parameters Setting and Preventive Maintenance
Page 18 of 20
5. Clean Pump Head
The pump head can be removed and cleaned if needed.
a. Turn the pump to STANDBY and unplug the power cord.
b. Unscrew the retaining screw that holds the pump head.
c. Remove the pump head and clean with water and soap. Hydrogen peroxide or a mild bleach solution
can be used to disinfect.
d. Let pump head dry before replacing and make certain the pump head is securely fastened with the
retaining screw.
e. If the pump head squeaks, spray the roller with Silicone spray (Heavy Duty Pure Silicone.)
Retaining Screw
Roller Pump