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Sarns TM

Dual Cooler-Heater

Operators Manual
Operators Manual
Dual Cooler-Heater
Part Number:
11160 - 115 Volt 60 Hz
4332 - 220 Volt 50 Hz

Cautions
Federal (U.S.A.) law restricts this device to sale distribution and use by or on the order of a
physician.

Proper surgical procedures and techniques are the responsibility of the medical professional.

It is the operator’s responsibility to use, check, and maintain this device according to the
labels of the product, accompanying instruction manuals, and any revisions of the labeling or
instructions that may be subsequently issued.

Service Policy
Only Terumo Cardiovascular Systems Corporation certified service technicians are autho-
rized to service or repair this device. Only Terumo Cardiovascular Systems Corporation
approved replacement parts may be used in this device. Terumo Cardiovascular Systems
Corporation approved parts are only available through Terumo Cardiovascular Systems
Corporation certified service technicians. Any service or repair by an unauthorized service
technician or use of unapproved parts will void your Terumo Cardiovascular Systems Product
Warranty and may increase the risk of a product failure.

Contact Terumo Cardiovascular Systems Corporation Service, your local Terumo company or
your authorized distributor for technical assistance and to arrange for service.

If the device is to be returned, instructions will be given for returning the device and a
Returned Goods (RG) number will be issued. For contaminated devices, request the appro-
priate Product Return Safety Pack. Returned devices must be packaged with adequate
protection against shipping damage. Include a note describing the problem, stating the RG
number, and giving the name, address, and telephone number of a person to contact for
additional information.

In the United States, contact the Terumo Cardiovascular Systems Corporation Technical
Support Department:

Terumo Cardiovascular Systems Corporation

6200 Jackson Road
Ann Arbor, Michigan 48103 U.S.A.
Telephone: (800) 441-3220
Facsimile: (734) 741-6449

Outside the United States, please contact your local Terumo company, your authorized distributor
or the Technical Support Department at Terumo Cardiovascular Systems Corporation.

Telephone: (734) 663-4145 Facsimile: (734) 741-6449

2
Table of Contents

Indications and Warnings

4 Product Description
4 Indications
4 Contraindications
4 Safety Warnings
4 Equipment Precautions
5 Specifications
5 Functional Description

6 Controls and Displays

Preparation
8 Connecting Equipment
9 Adding Water
9 Starting and Priming the System
9 Checking the System

Operation
10 Initiating Hypothermia
10 Maintaining Hypothermia
10 Rewarming
11 Correcting Equipment Problems

Maintenance
12 Setup
13 Sanitization Procedure
13 Cleaning and Sanitizing Procedure
13 Exterior Maintenance Procedure
13 Descaling Procedure
14 Decontamination Procedure
14 Weekly Operator Checks
14 Service Checks

3
Indications and Warnings
Figure 1: Dual Cooler-Heater
Product Description
TM
The Sarns Dual Cooler-Heater is a self-contained unit
for supplying cold and warm water to heat exchangers
during open-heart surgery. It supplies water at a rate of
up to 6.5 gallons per minute (25 liters per minute) at zero
head, and will provide a maximum pressure output of 11
TM
pounds per square inch (76,000 pascals). The Sarns
Dual Cooler-Heater can be used with heat exchangers
capable of accepting these flows and pressures.
Indications
TM
The Sarns Dual Cooler-Heater is indicated for use as a
water supply system to a blood heat exchanger in open-
heart surgery.
Contraindications
This device is not designed, sold, or intended for use
except as indicated. This device should not be used with
hypo-hyperthermia pads.
Safety Warnings
TM
It is the operator’s responsibility to use the Sarns Dual
Cooler-Heater and any attached equipment according to
the manufacturer’s instructions and good medical prac-
tices.
The Sarns Dual Cooler-Heater is not an automatic
TM
temperature regulating system; responsibility for monitor-
ing and maintaining patient temperature remains with the
operator.
4
If the device goes into the overtemperature condition and
the override system is used, it is especially critical that the
operator continue to monitor the output water tempera-
ture.
Disconnect this device from power source before inspect-
ing, cleaning, or preparing this device for use.
To control bacteria, maintain chlorine level between 3 to
5 ppm.
Observe proper safety precautions when using S-Klenz as
this is a phosphoric acid detergent.
Do not mix S-Klenz (acid descaler) with Interchlor
(chlorine sanitizer) as exothermic reaction will occur,
creating harmful chlorine gas.
Equipment Precautions
Never turn the power on unless the ice-water tank
contains at least 4 in. (10,2 cm) of water as running the
device dry will destroy the circulating pump. Never turn
the power on unless the water outlet line is connected to
the heat exchanger, directed to a drain or in a closed loop
as water will automatically exit the system.
This device requires a dedicated 20 amp power source for
the 115 volt model and a dedicated 10 amp power source
for the 220 volt model.
Grounding reliability can only be achieved when this
equipment is connected to an equivalent receptacle
marked “Hospital Use” or “Hospital Grade” which has
been inspected for proper grounding.
Do not use this device in or near an area where explosive
gases are being used or have been used.
To avoid electrical shock hazard, do not remove panels;
refer servicing to qualified service personnel.
When using Cooling and Recirculation Modes to drain
the unit, leave at least 1 in. (2,5 cm) of water in the tank
to prevent damaging the circulating pump. Do not drain
the device while in the Heating Mode as damage to the
heating element can result.
Use only Cage Klenz 100, S-Klenz and Interchlor as
cleaning agents, following the manufacturer’s directions
and safety precautions.* Do not exceed the recom-
mended strengh to prevent corrosion damage.
To avoid corrosion, do not allow the chlorine level to
exceed 10 ppm.
*Cage Klenz 100 and S-Klenz are products of Steris Corporation, Mentor, Ohio,
U.S.A.
*Interchlor is a product of Intercon S. Louis, Missouri, U.S.A.
Indications and Warnings
Specifications

Length: 24.5 inches (62,2 cm)

Width: 15.5 inches (39,4 cm)
Height: 27.5 inches (69,9 cm)
Weight, Empty: 75 pounds (34 kg)
Weight, Full: 125 pounds (57 kg)
Heater: 1500 watts
Water Tank: 8.5 gallons (32 liters)
Pump: 6.5 gallons per minute (25 liters per
minute) at zero head. 11 PSI (76,000 VALVES

pascals) maximum pressure.

Connections: Quick-connect water fittings. Attachment

fittings and 1/2 in. (1,3 cm) I.D. vinyl tubing are included Figure 2: Cooling Mode
in the accessories kit.

Power Requirements: For reliable operation, each Cooler-

Heater requires its own power source capable of provid-
ing the following:

Part Numbers 11160 4332

Voltage 115 VAC 220 VAC
Frequency 60 Hz 50 Hz
Amperage 20 Amps 10 Amps

Current Leakage: VALVES

60 microamps maximum for 115V;

90 microamps maximum for 200 V.

Ground Resistance: 0.1 Ohm maximum. Figure 3: Heating and Recirculating Modes

Grounding: A three conductor power cable is provided
for the protection of operating personnel and patient.
This power cord will ground the unit when connected to a
properly grounded electrical outlet. The unit is mounted
on conductive casters.
Functional Description
TM
The Sarns Dual Cooler-Heater consists of an ice-water
tank, pump, diverter valves, heater manifold and tempera-
ture thermostats. It has three operational modes: Cooling
Mode, Recirculation Only Mode, and Heating Mode.
In the Recirculation Only Mode, the water is pumped
through the heater manifold (Figure 3) without the
heating element on.
In the Heating Mode, the water is pumped through the
heater manifold and the heating element heats the water
to any one of four preset temperatures (Figure 3). If the
temperature of the water in the heater manifold should
rise to 43°C, the device will shut off and the OVERTEMP
light on the control panel will light.

In the Cooling Mode, water is pumped through the ice-

water tank (Figure 2). The output temperature of the
water, which is continuously monitored by the Output
Water Temperature thermometer, will stabilize at the
temperature of the water in the tank. The flow rate can be
varied in four preset increments.

5
Controls and Displays
D C

A
E

Figure 4: Front View

A. Control panel contains the controls and displays. D. Tank cover helps minimize temperature loss and
keep debris out of the tank.
B. Splash shield helps prevent fluid spillage onto the
control panel. E. Water Out fitting is a quick-connect fitting for the
water outlet line.
C. Ice-water tank holds the ice and water for the
hypothermia procedure. F. Water In fitting is a quick-connect fitting for the
inlet water line.

6
Controls and Displays
E
B
Figure 5: Control Panel
A. Power switch turns the entire device on and off. The
circulating pump is always pumping once the device
is turned on, regardless of the selector switch posi-
tion.
B. Power light lights whenever the device is energized.
C. Selector switch sets the operating mode to cooling,
heating or recirculation only
Cooling Mode pumps water through the ice-water
tank at one of four pump speed settings: MIN, 2, 3,
and MAX.
Recirculation Only Mode recirculates the water
without heating or cooling it.
Heating Mode warms the water according to the
temperature selection: 30°C, 38°C, 40°C, and 42°C.
These settings determine the temperature at which
the heater will be shut off and do not affect the rate of
heating.
D. Output Water Temperature thermometer monitors
the temperature of the water that is being pumped
from the device to the heat exchanger.
C
D
E Overtemp light turns on when the temperature of
the water in the heater manifold exceeds 43°C; the
circulating pump and heating element will shut off
when an overtemperature condition is detected.
F. Override button, when depressed, allows the
circulating pump to run in Heating Mode during an
overtemperature condition.
Pump circuit breaker, on the rear of the unit, stops
power to the circulating pump if the circuit overloads.
After 60 seconds, the circuit breaker can be reset by
pushing the red button.
Heater circuit breaker, on the rear of the unit, stops
power to the heating element if the circuit overloads.
After 60 seconds, the circuit breaker can be reset by
pushing the red button.
Drain lever, on the bottom of the unit, opens and closes
the plumbing drain. Position the lever parallel to the
bottom to close the drain; position the lever perpendicu-
lar to the bottom to open the drain.
7
Preparation
Connecting Equipment
Figure 6: Water Connections
Warning: Disconnect this device from power
source before inspecting, cleaning, or preparing this
device for use.
Make connections to the heat exchanger (Figure 6) using
parts from the accessory kit. Secure all tubing connec-
tions with clamps similar to those provided in the acces-
sory kit.
Note: New 1/2 in. (1.3 cm) I.D. vinyl tubing should be
installed before each use.
1. Set up the heat exchanger according to the
manufacturer’s instructions.
2. Prepare a Water In line (A).
• Attach a male quick-connect fitting to a 2 ft. (61 cm)
length of tubing.
• Attach the appropriate fitting for the heat exchanger
to the other end of the tubing.
• Connect this line from the WATER IN fitting on the
Dual Cooler-Heater to the Water Outlet fitting on the
heat exchanger.
8
B
C
E
3. Prepare a Water Out line (B).
• Attach another male quick-connect fitting to a 3 ft.
(91,4 cm) length of tubing.
• Attach the heat exchanger fitting to the open end of
this tubing.
• Connect this line from the WATER OUT fitting on
the Dual Cooler-Heater to the Water In fitting on the
heat exchanger.
4. Prepare a drainage line (C).
• Insert the straight-through legs of a plastic tee (D)
into the Water Out line.
• Cut tubing of sufficient length to reach a floor drain.
• Insert a ball valve (E) about 6 in. (15 cm) from one
end.
• Attach this end of the drainage line to the perpen-
dicular-leg of the tee.
Note: Use the drainage line to lower the water level in
the ice-water tank if the water level gets too high
when ice is added.
5. Secure all joints with tubing clamps.
Preparation
Adding Water
1. If the device has been drained, make sure the drain
in the bottom is closed; the drain lever should be
parallel to the bottom of the device when the drain is
closed.
2. Make sure the WATER IN and WATER OUT
connections are correct and the fittings are securely
in place.
3. Fill the ice-water tank with 3 or 4 gallons (11-15 liters)
of room temperature water (20-25°C). Make sure that
there are at least 4 in. (10,2 cm) of water in the ice-
water tank.
4. With the power switch in the OFF position, plug the
power cord into a power source of the proper
voltage, frequency and capacity (see the nameplate
on the rear of the device).
Precautions: This device requires a dedicated 20
amp power source for the 115 volt model and a
dedicated 10 amp power source for the 220 volt
model.
Grounding reliability can only be achieved when
this equipment is connected to an equivalent
receptacle marked “Hospital Use” or “Hospital
Grade” which has been inspected for proper
grounding.
Starting and Priming the System
Precautions: Never turn the power on unless the
ice-water tank contains at least 4 in. (10,2 cm) of
water as running the device dry will destroy the
circulating pump. Never turn the power on unless
the water outlet line is connected to the heat
exchanger, directed to a drain or in a closed loop as
water will automatically exit the system.
Both the Dual Cooler-Heater and heat exchanger must be
purged of entrapped air for efficient operation of the
system.
1. Turn the selector switch to Cooling Mode: MAX and
turn the power switch ON. Run at this setting until
air bubbles are no longer visible in the connection
tubing. Add water, if necessary, to maintain at least
4 in. (10,2 cm) in the tank.
Note: It is important that all air is removed during
this phase of priming or removal of air in Heating
Mode will be difficult.
2. Switch to Heating Mode: 30°C and watch carefully
for bubbles to appear in the outlet tubing. The instant
the bubbles appear, switch to Cooling Mode: MAX
until the air bubbles disappear. Remove air through
the heat exchanger until all air bubbles disappear in
the tubing. Repeat this procedure, alternating
Cooling and Heating Modes, until the bubbles no
longer appear when in Heating Mode.
Checking the System
1. Turn the selector switch through all four positions of
the Cooling Mode and observe that the pump runs at
four distinct speeds.
2. Turn the selector switch to the Recirculation Only
Mode; observe that the pump runs at a low speed.
3. Turn the selector switch through all four positions of
the Heating Mode. Allow the device time to heat up
to the selected temperature setting and check that the
Output Water Temperature reading stabilizes at each
setting.
9
Operation
Initiating Hypothermia
Figure 7: Ice Requirements
1. Shortly before initiating hypothermia, place the
required quantity of ice in the tank. Use Figure 7 to
estimate the amount of ice needed. Keep extra ice
available as the actual quantity used will vary.
Keep the ice-water tank covered to minimize tem-
perature loss and to keep debris out of the water.
2. Switch to Cooling Mode.
10
Maintaining Hypothermia
Maintain a temperature by switching between Cooling
Mode: MIN, Recirculation Only Mode, and Heating
Mode: 30°C. As maintaining a hypothermia temperature
depends on many factors, experimentation will be required
in each case.
Warning: The Sarns Dual Cooler-Heater is not an
TM
automatic temperature regulating system; responsibil-
ity for monitoring and maintaining patient tempera-
ture remains with the operator.
Rewarming
• Rewarm the patient by selecting the temperature in
Heating Mode at which you wish the heaters to shut
off.
• If the OVERTEMP light goes on, an overtemperature
condition exists. Switch to Cooling Mode: MAX until
the Output Water Temperature reading falls below
43°C. When returning to the Heating Mode, depress
the OVERRIDE button for several seconds until the
water in the heater manifold falls below 43°C and the
OVERTEMP light goes out, indicating that the device
is out of the overtemperature condition.
Warning: If the unit goes into the overtemperature
condition and the override system is used, it is
especially critical that the operator continue to
monitor the output water temperature.
Operation
Correcting Equipment Problems

Power light not on. Verify that the power cord plug is connected and the power switch is on.

Pump not running but power light on. Press the Pump circuit breaker button.

Water not heating but power light on Switch to Heating Mode and press the Heater circuit breaker button.
and pump running.

Thermometer does not stabilize at °C Contact Terumo Cardiovascular Systems Corporation Service if it varies
selected. by ± 2.5°C or more.

Not pumping adequately. Clean or replace circular tank screen (outlet) to remove any blockage, or
repeat prime procedure to remove air.

Overtemperature condition before Remove or bypass restriction in external lines. Contact Terumo
thermometer reaches 43°C. Cardiovascular Systems Corporation Service if problem continues.

Thermometer above 43°C but no Contact Terumo Cardiovascular Systems Corporation Service.
Overtemperature condition.

Insufficient water flow or heats and Have a qualified person check the water valves for blockage and clean the
cools too slowly inlet water strainer located inside the front cover.

Other Problems: If the problem continues, contact Terumo Cardiovascular Systems Corporation Service, your local
Terumo company, or your authorized Terumo distributor.

11
Maintenance
Cooler Heater Maintenance Fill and prime.
• Fill the tank to the maximum level with cold water
Frequency Maintenance Procedures Duration (about 8 gallons, 30,3 liters).
Daily Sanitize (Test Chlorine) 5 min • Select Cooling Mode: Maximum, turn the power ON
and run until air bubbles are no longer visible. Add
Weekly Clean and Sanitize 30 min
water, if necessary, to maintain at least 4 in. (10,2 cm)
Every Week Exterior Maintenance 20 min in the tank.
Every 6 Months Descale 1 hour Note: It is important that all air is removed during this
phase of priming or removal of air in Heating Mode
For excessive biofilm Decontaminate (which descales, 2-6 hours will be difficult.
cleans, decontaminates
and sanitizes) • Select Heating Mode: 30°C; the instant that the
bubbles appear in the outlet tubing, switch to Cooling
For adequate control of microbial contamination and scale Mode: Maximum until the air bubbles disappear.
buildup as well as routine maintenance, each of the above Repeat this procedure, alternating Cooling and
procedures must be performed at the required frequency. Heating Modes, until the bubbles no longer appear
To prevent bacterial growth, test and adjust the chlorine when in Heating Mode.
level daily. Cleaning should always be followed by
sanitizing; field studies indicate that performing one
procedure without the other may actually increase bacteria Precaution: Use only Cage Klenz 100, S-Klenz and
levels. Without routine cleaning and sanitization, exces- Interchlor as cleaning agents, following the
sive biofilm may form, requiring a prolonged decontami- manufacturer’s directions and safety precautions.*
nation procedure. The descaling procedure reduces hard Do not exceed the recommended strength to prevent
water deposits from affecting the operating efficiency and corrosion damage.
safety of the unit.1

Warnings: Observe proper safety precautions when

Setup (Detailed Steps Used Throughout
Maintenance Procedures)
Whenever “close the circuits”, “fill and prime”, or “drain”
are mentioned in the cleaning, descaling or decontamina-
tion procedures, follow the detailed steps provided below.
using S-Klenz as this is a phosphoric acid detergent.
Do not mix S-Klenz (acid descaler) with Interchlor
(chlorine sanitizer) as exothermic reaction will occur,
creating harmful chlorine gas.

Close the circuits Drain the unit.

• Connect the In and Out ports with about 3 ft.
(91,4 cm) of tubing.
• Position the unit over a sink or floor drain. Warnings: When using Cooling and Recirculation
Modes to drain the unit, leave at least 1 in. (2,5 cm) of
water in the tank to prevent damaging the circulating
pump. Do not drain the device while in the Heating
WATER OUT Mode as damage to the heating element can result.

• Disconnect the tubing from the Water In fitting; direct

WATER IN the Water Out line to a drain.
• Run in both the Cooling Mode: MAX and the Recircu-
lation Only Mode until the ice-water tank is almost
3 ft. (1 M) empty. Leave at least 1 in. (2,5 cm) in the bottom.
• Turn the power OFF and unplug the power cord from
the power source.
• Position the unit over a floor drain. Open the drain
beneath the unit by pushing the drain lever downward
until it is perpendicular to the bottom. Drain the
plumbing circuit. Then close the drain by pushing the
Figure 8 drain lever upward until it is parallel with the bottom.
• Reconnect the Water In and Water Out line.

*Cage Klenz 100 and S-Klenz are products of Steris Corporation, Mentor,
1Toigo, J. and Giraud, S., “What’s Growing in Your Heater/Cooler”, Ohio, U.S.A.
Perfusion Life , 1993;10 (10):18-19. *Interchlor is a product of Intercon S. Louis, Missouri, U.S.A.
12
Maintenance
Sanitization Procedure (daily) Exterior Maintenance Procedure (every week)
Test the total chlorine level using Chlorine Free* or • Wipe the cabinet with a damp cloth.
equivalent. • Do not refill until next use.

Warning: To control bacteria, maintain chlorine Warning: Disconnect this device from power source
level between 3 to 5 ppm. before inspecting, cleaning, or preparing this device
for use.

Precaution: To avoid corrosion, do not allow the
chlorine level to exceed 10 ppm.
If chlorine level is below 3-5 ppm:
• Select Cooling Mode - Maximum to circulate the
water.
• Add up to 2,5 ml of Interchlor to the tank. Run for 2
minutes.
• Select Heating Mode - 40°C; run for 2 minutes.
• Test the chlorine level.
If chlorine level exceeds 10 ppm:
• Drain half the water and replace with new water.
• Circulate. Run for 2 minutes in Cooling Mode -
Maximum and then for 2 minutes in Heating Mode -
40°C.
• Test the chlorine level. If still above 10 ppm, repeat
water replacement; if below 3-5 ppm, add up to 5 ml
Interchlor per above directions.
• Check the power cord. Inspect the wire insulation for
cracks, cuts, abrasions or other damage. If the plug is
damaged, have it replaced by a qualified person.
• Inspect and clean the circular tank screen. Replace if
damaged.
• Inspect the tank inlet fitting in bottom of ice-water
tank. Remove any obstructions.
• Check that the water fittings function properly.
• If a water leak is apparent, have a qualified person
remove the front cover and try to determine the cause
of the leak.
• Check for cracked or broken thermometer lens.
Descaling Procedure (every 6 months)
Descale more frequently in areas with a high
mineral content in the water supply.
Warnings: Observe proper safety precautions when
using S-Klenz as this is a phosphoric acid detergent.

Cleaning and Sanitizing Procedure Do not mix S-Klenz (acid descaler) with Interchlor
(minimum weekly) (chlorine sanitizer) as exothermic reaction will
occur, creating harmful chlorine gas.
Clean with Detergent
• Per Setup, close circuits. Fill and prime if necessary.
• Select Cooling Mode - Maximum. Descale
• To ≤ 8°C water, add 8 oz. of Cage Klenz 100 to the • Test for chlorine. Remove chlorine prior to descaling;
tank (8 oz. equals eight pumps from the 1 oz. dis- drain, fill and prime per Setup.
penser). Run for 5 minutes. • Select Cooling Mode - Maximum.
• Select Heating Mode - 40°C; run for 5 minutes. • To ≤ 8°C water, slowly add 8 oz. of S-Klenz to the
• Per Setup, drain. Wipe any debris from the tanks tank (eight pumps of the 1 oz. dispenser); run for 15
Then fill and prime. minutes.
• Select Heating Mode - 40°C; run 15 minutes.
Add Chlorine per Sanitization Procedure
• Select Cooling Mode - Maximum. Rinse and Drain
• Add 2,5 ml of Interchlor to the tank. Run for 2 • Per Setup, drain. Wipe any debris from the tanks.
minutes. Then fill and prime.
• Select Heating Mode - 40°C; run for 2 minutes. • Select Cooling Mode - Maximum and run for 2
• Test and adjust the chlorine level within the pre- minutes.
scribed limits. • Select Heating Mode - 40°C; run 2 minutes.
• Drain the rinse water; fill with clean water and prime.
• Perform complete Cleaning and Sanitizing Procedure.

*Chlorine Free indicator strip is a product of Industrial Test System,

Rock Hill, South Carolina, U.S.A.
13
Maintenance
Decontamination Procedure (when needed)
Decontaminate whenever biofilm is evident, which may
be noticeable by a discoloration or cloudiness in the
external fluid lines.
Prepare first
• Descale and Rinse according to the Descaling
Procedure.
• Clean (without sanitizing) according to Cleaning and
Sanitizing Procedure.
Remove Biofilm
• Fill tanks and prime.
• Select Cooling Mode - Maximum.
• To ≤ 8°C water, slowly add 10 oz. of Interchlor
sanitizer to the tank. Run for at least 1 hour, adding
ice if necessary to keep the water below 20°C.
• Select Heating Mode - 40°C. Run for at least 1 hour.
Note: If biofilm is still visible, continue alternating
between Cooling Mode - Maximum and Heating
Mode - 40°C, running for 1/2 hour at each setting.
Keep below 20°C when in Cooling Mode. Do not
add more sanitizer. As much as four hours additional
time may be required to remove excessive biofilm.
Rinse
• Drain, fill and prime.
• Select Cooling Mode - Maximum and run for 2
minutes.
• Select Heating Mode - 40°C. and run for 2 minutes.
• Test the chlorine level. Rinse again if necessary.
• Replace the external water line once the unit is
drained. Store the unit.
Before Use
• Fill and prime. Sanitize per Sanitization Procedure.
14
Weekly Operators Checks
Perform the following inspections weekly.
Warning: Disconnect this device from power
source before inspecting, cleaning, or preparing this
device for use.
• Check the power cord. Inspect the wire insulation for
cracks, cuts, abrasions or other damage. If the plug is
damaged, have it replaced by a qualified person.
• Inspect and clean the circular tank screen. Replace if
damaged.
• Inspect the tank inlet fitting in bottom of ice-water
tank. Remove any obstructions.
• Check that the water fittings function properly.
• If a water leak is apparent, have a qualified person
remove the front cover and try to determine the cause
of the leak.
• Check for cracked or broken thermometer lens.
Service Checks
A maintenance inspection should be conducted every six
months to ensure proper operation.
Only Terumo Cardiovascular Systems Corporation
certified service technicians are authorized to service or
repair this device. Only Terumo Cardiovascular Systems
Corporation approved replacement parts may be used in
this device. Terumo Cardiovascular Systems Corporation
approved parts are only available through Terumo Cardio-
vascular Systems Corporation certified service techni-
cians. Any service or repair by an unauthorized service
technician or use of unapproved parts will void your
Terumo Cardiovascular Systems Product Warranty and
may increase the risk of a product failure.
Limited Warranty
Terumo Cardiovascular Systems Corporation warrants that this product will be free from
defects in workmanship or material for one year from the date of shipment. This warranty
does not apply to filters, light bulbs, fuses, or other expendable items, or to those parts dam-
aged by improper use, accident, improper maintenance or unauthorized repair.

THIS WARRANTY IS MADE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR

IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.

Limitation of Remedies
As your exclusive remedy under this warranty, Terumo Cardiovascular Systems Corporation
will repair or replace free of charge, or at Terumo Cardiovascular Systems Corporation's
option, return the purchase price of, any part or unit found to be defective in workmanship or
material during one full year from the date of shipment.

Terumo Cardiovascular Systems Corporation shall not be liable under any circumstances for
any consequential, incidental or indirect damages or expenses associated with this product or
its use. This exclusion does not apply to claims for personal injury by a third party.

Customers
If a warranty condition develops, contact Terumo Cardiovascular Systems Corporation Ser-
vice, or your authorized distributor. This warranty gives you specific legal rights; you may
have other rights as well, which vary from state to state in the U.S.A.

In the United States, contact the Service Department:

Terumo Cardiovascular Systems Corporation

6200 Jackson Road
Ann Arbor, Michigan 48103 U.S.A.
Telephone: (734) 663-4145 (800) 521-2818
Facsimile: (734) 741-6449

Outside the United States, please contact your authorized Terumo Cardiovascular Systems
Corporation distributor regarding local warranty conditions or contact the Technical Support
Department at Terumo Cardiovascular Systems Corporation:
Telephone: (734) 663-4145
Facsimile: (734) 741-6449

Note: All returned goods must have a Returned Goods (RG) number prior to return.

15
 Manufactured by
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 Jackson Road Ann Arbor, Michigan 48103-9300
(734) 663-4145 (800) 521-2818

EC Rep.
TERUMO EUROPE N.V.
Interleuvenlaan 40,
3001 Leuven, Belgium

TERUMO CORPORATION
44-1, 2-Chome, Hatagaya, Shibuya-ku,
Tokyo 151-0072, Japan

Printed in U.S.A. 802261 R/B

© TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 2005 October, 2005