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WAS 34-9997-0679-8
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SYM CHG. NO. DESCRIPTION BY CHK. APVD. DATE

REVISIONS

UNLESS OTHERWISE SPECIFIED: DRAWN TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

DO NOT SCALE DRAWING. DIMENSIONS ARE IN INCHES.
CHECKED
Ann Arbor, Michigan
METAL PARTS
TITLE
- SHEET METAL BENDS TO BE MINIMUM RADII. PROJECT
- REMOVE ALL BURRS AND SHARP EDGES. ENGINEER
- MACHINED INSIDE CORNERS SHARP TO .000/.005 R. MANUFACTURING Refer to ECO OPERATORS MANUAL TCM II TUV
- SURFACE FINISH 125√MAX.
MOLDED PLASTIC PARTS
- MAX. FLASH ≤ .001
REGULATORY
PART NUMBER 802014
- MAX. MISMATCH ≤ .001 Q.A. SHEET DRAWING NUMBER REV.
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.X ± .06 .XX ± .02 .XXX ± .005 ANGULAR ± 1/2°
REF. ONLY
RELEASE
APPROVAL 1 1
______ OF ______ 802014 B
Sarns TM

TCM II

Operators Manual

System Software Version 2.0

Remote Software Version A
Sarns TM

TCM II
Operators Manual

4415 115 V with Cardioplegia

4416 220-240 V with Cardioplegia 0197

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, accompany-
ing 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 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 Cardiovascular Systems
Corporation certified service technicians. Any service or repair by an unauthorized service technician or use of unap-
proved 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 appropriate 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
Europe: Technical Support - Medical Electronics - Call Free Number from:
AT 0800-293711 BE 0800-94410 DK 808-80701
FI 0800-115226 IE 1800-553224 CH 00800-563694
FR 0800-908793 IT 800-785891 GB 0800-9179659
DE 0800-1808183 NL 0800-0222810 NO 800-12270
GR 00800-3212721 ES 900-963251 SE 020-791373

Other countries call +32 16 381204 at international rates

E-mail: meservice@terumo-europe. com Fax: +3216381420

2
Table of Contents

Product Definition
4 Description
4 Indications
4 Contraindications
4 Warnings
4 Precautions

Controls And Displays

5 Main Unit
7 Cardioplegia Water Supply
8 Temperature Display Module

Preparation
9 Checking Ice And Water
9 Connecting Equipment
10 Starting And Priming The System

Operation
12 Using The System
13 Resolving Alarm Conditions
14 Correcting Equipment Problems
15 Using The Ice Maker

Maintenance
16 Setup
17 Sanitization Procedure
17 Cleaning and Sanitizing Procedure
17 Clean the Coils
18 Descaling Procedure
18 Decontamination Procedure
18 Periodic Operator Checks
19 Service Checks
20 Accessories

Technical Support
22 Specifications
24 EMC Tables
27 Functional Description
29 Theory Of Operation
30 Diagrams
31 Symbol Key

3
Product Definition
Description
The SarnsTM TCM II (system) is a source of tempera-
ture-controlled water for blood heat exchangers used in
an extracorporeal circuit and for blankets to externally
heat or cool the patient. It also freezes water for an ice
supply, monitors temperatures in the patient and
extracorporeal circuit, and allows gradient rewarming
relative to a venous blood temperature.
The SarnsTM TCM II also features a Cardioplegia System
which will supply cooling water for cardioplegia.
Note: For a complete description, see the Specifica-
tions, Functional Description, and Theory of Operation
in the Product Description section of this manual.
Indications
The SarnsTM TCM II is indicated for controlling and
monitoring patient temperature.
Contraindications
This device is not designed, sold, or intended for use
except as indicated.
Warnings
It is the operator’s responsibility to use the SarnsTM TCM
II and any attached equipment according to the
manufacturer’s instructions and good medical practices.
The SarnsTM TCM II is not completely automatic;
responsibility for monitoring patient temperatures and
rate of temperature change remains with the operator.
To obtain accurate temperature readings, use only
probes specified by Sarns for use with the Temperature
Probe Module.
Take care when displaying the alarm setting. Depress-
ing the alarm switch for more than 1 second will change
the alarm setting.
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.
4
Precautions
The system must be properly primed; running the
pumps and heaters with the device dry will damage
them.
The water level in the large tank must never rise above
the maximum level as water may damage the inside of
the unit; this water level should not drop below the
minimum level as there may be a loss of system
performance (see maximum-minimum label).
The SarnsTM TCM II requires a dedicated 20 Amp power
source for the 115 volt model and a dedicated
15 Amp power source for the 220-240 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.
Use care when handling the Temperature Display
Module; the controls, displays, or circuitry may be
damaged if the module is dropped, struck, or immersed
in water.
The use of accessory equipment not complying with the
equivalent safety requirements of this system may lead
to a reduced level of safety of the resulting system.
Consideration relating to the choice shall include: use
of the accessory in the patient vicinity; evidence that
safety certification of the accessory has been performed
in accordance to the appropriate IEC 60601-1 and/or
IEC 60601-1-1 harmonized international standards.
Equipment used to heat and cool the water used to
regulate the temperature of the blood supplied to a heat
exchanger should be rated Type CF. If the equipment is
not Type CF, and a malfunction occurs, the possibility
exists that electrical current may pass through the heat
exchanger and into the patient perfusion circuit.
This device needs special precautions regarding electro-
magnetic compatibility (EMC) and needs to be installed
and put into service according to the EMC information
provided in the Technical Support section.
Portable and mobile radio frequency (RF) communica-
tions equipment can affect this system.
Use only those accessories, transducers or cables
specified as use of non-specified items may result in
increased emissions or decreased immunity of the
system.
*Cage Klenz 100, and S-Klenz are products of Steris Corporation, Mentor, Ohio, U.S.A.
*Interchlor is a product of Intercon Chemical Company, St. Louis, Missouri, U.S.A.
Product Definition
This system should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is
necessary, observe the system closely to verify normal
operation in the configuration in which it will be used.
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 strength to prevent corrosion damage.
To avoid corrosion, do not allow the chlorine level to
exceed 10 ppm.
Controls and Displays
Main Unit
Figure 1: Side Panel
A. System Power Switch turns the system power on
and off and serves as a circuit breaker for the
system.
Do not use chemical solvents such as alcohol, ether,
acetone, etc. in or on any part of the system as such
solvents may be destructive to the device. Do not spill
anesthetics on the system or accessories as chemicals
such as Forane (isofluorane) may be destructive.
Remove any lint from the refrigeration coils to prevent
damaging the ice maker. Take care when cleaning the
refrigeration coils as the coils have sharp edges.
B. Ice Maker Switch turns the ice maker on and off
and serves as a circuit breaker for the compressor.
When the ice maker switch is on, the compressor
cycles on and off as needed to make and maintain
an ice block.
5
Controls and Displays
Main Unit (Continued)
Modes are started by depressing the mode switch; modes are stopped by selecting another mode. The Defrost
mode is unique in that it may be entered only from the Standby mode and is stopped by returning to the Standby
mode. All select switches must be depressed for at least 1/2 second to register. A green LED lights to indicate
which functions are selected.
Figure 2: Front Panel
A. ICE MAKING Indicator Lamp lights when the ice
making function is active.
B. Water Temperature Display shows the output water
temperature.
C. Cardioplegia Water Switch allows momentary display
of the cardioplegia outlet water temperature on the Water
Temperature display.
D. STANDBY (Mode) Switch selects a neutral mode in
which temperatures may read but valves, pumps, and
heaters are not operating (except during startup when
the valves open to allow internal priming).
E. COOLDOWN (Mode) Switch opens valves to circulate
cold water from the large tank.
F. MAINTAIN (Mode) Switch begins warming water or
adding cold water to attain and maintain an operator-
selected temperature.
G. Maintain Temperature Display shows the selected
maintain temperature. During startup, this display shows
the software version and then 25°C.
H. MAINTAIN TEMPERATURE Switches raise or lower the
maintain temperature setting within a range of 0°-42°C.
I. REWARM (Mode) Switch activates the heaters to warm
water at a maximum rate up to 42°C and circulates the
warm water.
6
J. Gradient Switch limits the water temperature in Maintain
or Rewarm modes to no more than 6°C or 10°C above
the temperature read by Probe G. This switch is
designed for use with a venous temperature probe.
When the Gradient switch is inactive, the maximum
rewarm temperature is automatically 42°C.
K. DEFROST (Mode) Switch circulates warm water
through the large tank until the water reaches 20°C; then
the unit automatically reverts to Standby mode.
The following alarms have specific warning indications: a red
LED lights to indicate the specific alarm condition and, except
for the Low Flow to Blanket warning, a two-second buzzer
sounds.
L. H2O > 42°C LED lights to warn that the water tempera-
ture is at or above 42.5°C. The heaters are automatically
turned off. The light and buzzer warnings will continue
until the temperature is below 42°C.
M. Pump Not Primed LED lights to warn that the main
pump is not primed. The light and buzzer warnings will
continue (or reoccur) until the pump is primed and
restarted by pressing Cooldown, Maintain, Rewarm or
Defrost.
N. Low Flow to Blanket LED lights to warn that the water
flow for the blanket is low.
O. Service LED lights to warn that the temperature display
and temperature control may be malfunctioning.
Controls and Displays
Cardioplegia Water Supply
Figure 3: Cardioplegia Panel
A. Cardioplegia Switch (CPG) starts or stops the
water circulating pump. Flow parameters are
determined by the speed and water circuit selected.
B. Speed Switch (RPM) selects the cardioplegia
pump speed. LED 1 lights for low speed, LED 2
lights for medium speed, and LED 3 lights for high
speed.
C. LARGE TANK Switch sets the system to deliver
water from the large tank to the cardioplegia water
outlet.
D. SMALL TANK Switch sets the system to deliver
water from the small tank to the cardioplegia water
outlet.
E. LARGE TO SMALL Switch sets the system to
recirculate water from the large tank to the small
tank.
To display the water temperature, use the Cardioplegia
Water switch on the main panel.
7
Controls and Displays
Temperature Display Module
C
B flash to indicate alarms. If the alarm limits for two
D probes are exceeded, both probe LEDs will flash; if one
A of these probes is also selected for display, its LED will
E
F
Figure 4: Module Panel
At the top of this module are the controls and displays
for temperature monitoring and at the bottom are
remote controls and displays for the Sarns™ TCM II.
The system will respond to the most recently entered
information regardless of whether it is entered on the
main panel or the remote panel.
A. Probe Display Switch selects which probe’s
information will be displayed. Selections ar marked
on the switch. The probe LED lights to indicate the
probe selected.
B. Temperature Display shows the probe temperature
and the following information:
--- Indicates that there is no probe connected
or that the temperature is below -0.4°C.
99.9 Indicates that the temperature is over
50°C.
Blank Indicates that there is no temperature
conversion module or that the module is
not functioning correctly.
8
The top display also displays the selection range and
settings for the temperature limit alarms.
C. Probe LED lights to identify which probe’s information
is being displayed. The LEDs for Probes A, B, or C also
flash at a higher rate.
D. Probe Labels identify the probes. The labels are
alphabetically marked to correspond with the probe
outlets in the back of the main unit; erasable writing
space is available to mark the probe location in the
patient or extracorporeal circuit. Probe G is labeled
“Gradient.”
E. HIGH and LOW Alarm Switches display or set tem-
perature limit alarms for probes A, B, or C. When an
alarm switch is depressed for less than one second, the
alarm setting for the selected probe is displayed. When
an alarm switch is depressed for more than one second,
the display cycles through the selection range; releasing
the alarm switch will set the last displayed number as
the new alarm limit. If the temperature exceeds the
alarm limit, a warning buzzer will sound once and the
probe LED will flash.
F. TEST Switch initiates a test to verify that the Tempera-
ture Probe Module is functioning correctly. During this
test, the top display pertains to the first Temperature
Probe Module, the middle display pertains to the middle
Temperature Probe Module, and the bottom display `
pertains to the last Temperature Probe Module. When
the test switch is depressed, the display must indicate
25 ± 0.4°C; the display will be blank if no module is con-
nected. Releasing the test switch will return the display
to its prior state.
The remote control switches function in the same manner as
their counterparts on the main unit.
Preparation

Checking Ice and Water

1. See that the System Power is OFF.

2. Check that there is an adequate ice supply. A

50 lb. supply of ice should be sufficient for one
case. To make additional ice, see “Using the Ice
Maker” in the Operation section.

3. Add fresh cold water up to the maximum water

level for each tank. The maximum water level for
the large tank is indicated on the label located near
the pressure switch in the large tank. The maxi-
mum water level for the small tank is attained
when water begins overflowing from the small tank
to the large tank.

Connecting Equipment
Connect the Heat Exchangers and Blanket (Figure 5)

1. Use new sections of PVC tubing to connect

equipment.
2. Prepare a drainage line for cardioplegia and
arterial water Out lines: insert a ball-type valve
(A) into the middle of a drainage line. Close the
valve. Attach the drainage line to a tubing section
with a tee (B).
3. Attach the water fittings (C) to the tubing sections
and secure the connection with tubing clamps (D).
4. Attach the tubing sections to the heat exchangers
and blanket.
5. Insert the water fittings into the appropriate In and
Out ports on the system: CPG H2O for the
cardioplegia heat exchanger, ART H2O for the
arterial heat exchanger, and BKT H2O for a blanket.
Note: During use, keep the drain valves closed and do
not drain attached equipment. The system ports are
internally connected to a common water source such
that draining the attached equipment may drain the
entire system.
Figure 5: Water Connections
Connect the Display Module (Figure 6)
Select any 1 5/8 in.(4,1 cm) upright pole that is within
7.5 ft. (2,3 m) of the main unit. Lower the support
bracket (A) over the pole until the bracket is at the
desired position; tighten the thumbscrew (B). Position
the back of the module so that its slot is directly over
the desired support tab (C); pull the module downward
until it is securely on the tab.
Connect the Temperature Display Module to the main
unit before the System Power is turned on. Insert the
module plug into the socket which is located in the
pocket on the main unit. Be sure that this plug is
securely connected.

Figure 6: Bracket

9
Preparation
Connect the Probes
Warning: To obtain accurate temperature read-
ings, use only probes specified by Terumo
Cardiovascualr Systems Corporation for use with
the Temperature Probe Module.
Insert the temperature probes into the sockets on the
back of the system (see Figure 7). Each letter, A, D, G,
etc., corresponds to a Probe Label on the remote unit.
Write the intended use of the probe on the correspond-
ing Probe Label. Do not use permanent ink markers or
coloring pens as they can stain the writing surface. Use
a mild solvent or soft eraser to remove markings.
Figure 7: Temperature Probe Modules
Note: When rewarming to a gradient, Probe G must
measure venous blood temperature.
10
Starting and Priming the System
Start the Unit
1. See that the Ice Maker and System Power switches
are off.
2. Plug the power cord into a wall outlet of proper
voltage, frequency, and capacity as indicated on
the nameplate label.
3. Turn the System Power and Ice Maker on.
Check the Startup Conditions
1. During the self test period, check that:
• The buzzer sounds and the LEDs light for 3 seconds.
• The buzzer stops and all the LEDs go off for 1
second.
• The software version appears on the Maintain and
Water Temperature displays for 3 seconds.
2. During the internal prime period, check that:
• The Standby LED flashes, indicating that the
system has automatically begun internal priming.
• The Maintain Temperature display shows 25°C on
both the main and remote controls.
• The high speed LED and the Large to Small Tank
LED light on the cardioplegia water panel.
• LEDs for Probes A, D, and G light and the tem-
perature displays indicate the room temperature on
the Temperature Display Module.
• The Standby LED stops flashing once the internal
prime is completed.
3. Before priming attached equipment, check that:
• The water level is up to the maximum level.
• The Standby LED lights continuously while the
Cooldown LED flashes.
Note: Cooldown LED flashes once complete mode
selection is available. Typically the operator will
select Cooldown mode and start priming the
attached equipment. However, if startup is the
result of a system monitor circuit or a power failure
the equipment will already be primed and it is
possible to proceed to other modes.
If the startup conditions are incorrect, turn the System
Power Switch off for 2 seconds, then back on, and
check again. If they are still incorrect, do not use the
equipment; Terumo Cardiovascular Systems Service,
your local Terumo company or your authorized Terumo
distributor.
Preparation
Starting and Priming the System (Continued)
Prime the Attached Equipment
Precaution: The unit must be properly primed;
running the pumps and heaters with the device
dry will damage them.
Remove air from the entire system including attached
equipment:
1. Run in Cooldown mode until air bubbles disappear
from the external tubing.
2. Turn the Cardioplegia on in Large Tank mode and
run until all air bubbles disappear in the external
tubing. Turn the Cardioplegia off.
3. Run in Rewarm mode to remove air from the
internal warming circuit. If air bubbles appear in
the external tubing, immediately change back to
the Cooldown mode until the air bubbles disappear.
Then alternate between Cooldown and Rewarm
modes until the unit will operate in Rewarm mode
without external air bubbles. Return to Standby
mode.
Check the Water Level Again.
Precaution: The water level in the large tank must
never rise above the maximum level as water may
damage the inside of the unit; this water level
should not drop below the minimum level as there
may be a loss of system performance (see maxi-
mum-minimum label).
Test the Temperature Probe Modules
Depress the TEST switch; the displays must read
25° ± 0.4°C. If the readings fall outside this range,
contact Terumo Cardiovascular Systems Corporation
Service. Release the test switch and displays should
show probe information if the probes are connected.
Set the Alarm Limits
Select Probe A, B, or C; the probe LED will light. To set
a high or low alarm limit, depress the appropriate alarm
switch for over one second and the numbers appearing
on the top display will cycle through the selection range.
When the desired number appears, release the alarm
switch to set the new alarm limit.
Check the Remote Controls
Try the Maintain Up and Down switches. Change
modes and check that modes function when using the
remote unit and that the proper LEDs light on the
remote and main panels.
If the unit does not respond properly to the above
checks, do not use it; contact Terumo Cardiovascular
Systems Service, your local Terumo company or your
authorized Terumo distributor.
11
Operation
Using the System
Warnings: It is the operator’s responsibility to use
the SarnsTM TCM II and any attached equipment
according to the manufacturer’s instructions and
good medical practices.
The SarnsTM TCM II is not completely automatic;
responsibility for monitoring patient temperatures
and rate of temperature change remains with the
operator.
Do not depress the alarm switch for more than 1
second or the alarm setting will be changed.
Note: Following standard practices for electronic
devices, monitor this equipment closely when it is
exposed to intense electrical noise or fluctuating line
voltage. Strong electromagnetic fields radiated from
equipment elsewhere in the operating room (particularly
defibrillators and electrocautery devices) or fluctuations
in AC line voltage may compromise performance or
damage the equipment.
Mode Selection
Use the Standby mode at any time to stop the pumps
and heaters; this mode allows temperature monitoring
without the selection of Cooldown, Maintain or Rewarm
modes.
Use the Cooldown mode for maximum cooling.
Use the Rewarm mode for warming to a maximum of
42°C.
Use the Maintain mode to both cool or warm to a set
water temperature and to maintain that water tempera-
ture:
• Maintain mode may be set and initiated after
starting in either Cooldown or Rewarm mode;
however, begin the Maintain mode before reaching
the desired body temperature to prevent warming
or cooling beyond the desired temperature.
• Maintain mode may be used to begin cooling or
warming; beginning in the Maintain mode avoids
the possibility of waiting too long to initiate the
Maintain mode and thus overshooting the desired
temperature.
• Maintain mode with several settings may be used
for a sequence of water temperature changes to
approximate rate control. In some cases it may be
12
desirable to very slowly raise or lower the patient
temperature. By setting several Maintain tempera-
tures, each a limited number of degrees warmer or
cooler than the existing water temperature, the
change in water temperature can be slowed down
or varied considerably depending on the number of
Maintain settings and the temperature difference
between the settings. Maintain mode can not
increase the rate of temperature change.
Use Gradient Rewarming to control the rate of rewarm.
Select a gradient of 6° or 10° on the main panel. Check
that Probe G is measuring the venous blood tempera-
ture. Use the Rewarm mode for a maximum water
temperature of 42°C or set a Maintain temperature limit
(on the main panel) and then use the Maintain mode.
NOTE: If there is an error condition for Probe G,
the gradient selection will not function; instead, the
unit will revert to Rewarm mode or Maintain mode
without the gradient.
For cardioplegia, use the Large Tank or Small Tank for
pressurized-water heat exchangers and the Large to
Small Tank for drop-in heat exchangers.
Additional Ice
A 50 lb. (22,7 kg) supply of ice should be sufficient for
one case. Two hours between cases should be allotted
for the compressor to partially replenish the ice supply;
see “Using the Ice Maker”.
To add ice to either tank during surgery, remove only an
equivalent amount of water from the large tank by using
the arterial water drainage line.
Note: During surgery, do not drain equipment
attached to the system; as the ports are internally
connected to a common water source, draining the
attached equipment may drain the entire system.
Keep the tank covers in place during operation to help
minimize temperature loss and keep debris out of the
water. Do not stand or sit on the unit; weight may break
the top.
Precaution: The water level in the large tank must
never rise above the maximum level as water may
damage the inside of the unit; this water level
should not drop below the minimum level as there
may be a loss of system performance (see maxi-
mum-minimum label).
Operation

Resolving Alarm Conditions

When an alarm condition occurs, first try the suggested procedure. If the alarm condition continues, do not use
the equipment; contact Terumo Cardiovascular Systems Service, your local Terumo company or your authorized
Terumo distributor. Whenever there is a major problem with the system, use an alternate source of water and
means of temperature monitoring until the situation is corrected.

Alarm Condition Procedure

H2O > 42°C Warning Switch to Cooldown mode until the water temperature reaches a satisfactory level;
the warning LED will go out and the buzzer will stop when the temperature drops
below 42°C. Return to Rewarm mode if desired.

If this warning should activate with a minimal load, such as only a blanket
attached, set the unit in Maintain mode at about 40°C until the additional
equipment is attached.

Pump Not Primed Warning
If adequate water, try selecting any mode which will activate the main pump
(Cooldown, Maintain, Rewarm or Defrost). If the alarm continues, check for leaks.
Add water when necessary. Turn the power Off for two seconds and then back On.
Use Cooldown, Cardioplegia and Rewarm to complete priming the system. Reset
the controls and continue using the unit.

Low Flow to Blanket Warning Check for leaks, kinks, or blockage in the tubing for the blanket.

Service Warning If the Water Temperature display shows zero during this warning, do not use
Maintain and Gradient Rewarm modes as temperature will increase to 42°C.
Monitor the patient and water temperature closely to protect the patient and to
assess the conditions of the unit; the surgical team must decide whether to
continue using the Sarns™ TCM II or to change to an alternate source of water.

Recurrence of Startup Check the startup conditions are correct. Reset controls; continue using the unit.

Temperature Display Module Unplug the remote from the main. Gradient rewarming may be continued although
panel blank due to problem with the venous blood temperature will not be displayed.
the module

13
Operation
Correcting Equipment Problems
Slow or no water flow.
Slow or no cooldown.
Excessive noise.
Compressor not running.
Defrost mode will not start.
6° or 10° gradient LEDs not
functioning properly.
Temperature displays are incorrect.
Startup does not occur on
Temperature Display Module.
Remote screen goes blank.
Other Problems:
14
Check:
• Water supply. Priming requires water up to the fill line of the large tank.
• Outlet screens (in the bottom of tank) for blockage.
• Plumbing circuit for blockage.
• Plumbing for leaks; tubing for kinks or air.
• Water fitting connections.
• Attached equipment.
Check the ice supply and the water flow.
Check the lines for air.
Check:
• Ice Supply. Sensor will turn the compressor off if the ice is already
made; the Ice Making lamp will remain on.
• Operating mode. Compressor does not function in Defrost mode or
whenever both heaters are on.
• Time that has elapsed since the switch was depressed. There is a
5 minute delay after the switch is depressed before the compressor
turns on.
Check:
• Entry mode. Entry to Defrost mode must be from Standby mode.
• Ice supply or water temperature. If the water temperature is not below
20°C, the Defrost mode defaults to Standby mode.
Check the Temperature Probe in the G socket for proper connection.
Check:
• Probe Selection. See that the correct probe was chosen for display.
• Probes for proper connection.
• Probes for proper functioning; replace if necessary.
• Probe for proper placement.
• Probe labels for correct marking.
• Probe modules. Press test to check modules.
Check the cord connection. See that it is properly connected to the main
unit.
Check:
• Cord connection. If the cord is disconnected from the socket, the
Display Module may be reconnected: insert the plug in the socket; turn
the System Power Off and then On in order to repeat startup for both
the main and the display unit; reset all the modes, temperatures, and
alarms on the main and remote panels.
Note that rewarming to a gradient may be continued without the Display
Module in use but it will not be possible to display the temperature of
Probe G.
First attempt to correct the situation by turning the System Power Off and
back On. If the problem continues, contact Terumo Cardiovascular
Systems Service, your local Terumo company or your authorized Terumo
distributor.
Operation

Using the Ice Maker
Up to ten hours before use:
1. Remove any attached equipment. Turn the System
Power and Ice Maker On.
2. Use the Defrost mode to melt the ice off of the
cold plate and sensor; excess ice or uneven or high
ice buildup around the ice sensor may cause poor
cooling performance, premature compressor
shutoff or damage the pump.
Note: The Defrost mode can only be entered
through the Standby mode.
Ice may be saved for 48 hours. After 48 hours,
follow the Cleaning and Sanitizing Procedure in
the Maintenance Section. The unit may be stored
indefinitely only when cleaned and drained.
To replenish ice between surgical procedures:
Note: Defrost is not necessary when an operator is
monitoring the ice maker.
1. Turn the Ice Maker On and select Standby mode.
2. Fill the large tank to the maximum level with fresh
cold water and replace the cover. The Ice Making
LED will light to indicate ice is being made.

When the water temperature reaches 20°C, the unit 3. Check to see the sensor has turned the compressor
will automatically go into Standby mode. After a off when an adequate supply of ice is made.
delay of up to 5 minutes, the compressor will turn
on. Note: To reduce noise during surgical procedures, the
ice-maker may be turned off as long as there is a
3. Turn the System Power off once the compressor sufficient ice block to complete the procedure.
has started. Leave the Ice Maker On; the ice
sensor will automatically turn the compressor off
when an adequate amount of ice is made.

4. Check the ice block. A large block of ice should

be formed around the cold plate. Ice should
surround the tip of the ice sensor. There should be
1 to 1-1/2 in. (2,5 to 3,8 cm) of water between the
front and rear of the tank and the ice block. The
sides of the ice block may touch the tank.

15
Maintenance

Frequency Maintenance Procedures Duration

Daily Sanitize (Test Chlorine)
Weekly Clean and Sanitize
Every 3 Months Clean coils
Every 6 Months Descale
For excessive biofilm Decontaminate (which descales,
cleans, decontaminates and
sanitizes)
For adequate control of microbial contamination and
scale buildup as well as routine maintenance, each of
the above procedures must be performed at the re-
quired frequency. To prevent bacterial growth, test and
adjust the chlorine level daily. Cleaning should always
be followed by sanitizing; field studies indicate that
performing one procedure without the other may
actually increase bacteria levels. Without routine
cleaning and sanitization, excessive biofilm may form,
requiring a prolonged decontamination procedure. The
descaling procedure reduces hard water deposits from
affecting the operating efficiency and safety of the unit.1
Setup (Detailed Steps Used Throughout
Maintenance Procedures)
Whenever “close the circuits”, “fill and prime”, or
“drain” are mentioned in the cleaning, descaling or
decontamination procedures, follow the detailed steps
provided below.
Close the Circuits
• Connect each set of In and Out ports with about
5 min
30 min
2 ft. (0,6 m) of tubing; include a ball type valve
20 min and drainage line in the cardioplegia and arterial
1 hour water circuits.
• Position the unit near a sink or floor drain.
2-6 hours
Fill and Prime
• Fill the large tank to the maximum level with cold
water, fill the small tank with cold water until it
begins to overflow into the large tank.
• Turn the unit on and run in the Cooldown mode to
remove air from the external tubing.
• Select Defrost. Turn the Cardioplegia on in Large
Tank mode and run until all air disappears from
the external tubing. Turn the Cardioplegia off.
• Run in Rewarm mode. If air bubbles appear in the
external tubing, immediately change back to the
Cooldown mode until the air bubbles disappear.
Then alternate between Cooldown and Rewarm
modes until the unit will operate in Rewarm mode
without external air bubbles. Return to Standby
mode.
Note: The Defrost mode can only be entered
through the Standby mode.
Precautions: The system must be properly
primed; running the pumps and heaters with the
device dry will damage them.
Use only Cage Klenz 100, S-Klenz and Interchlor as
cleaning agents, following the manufacturer’s
directions and safety precautions.* Do not exceed
the recommended strength to prevent corrosion
damage.

Warnings: Observe proper safety precautions

when using S-Klenz as this is a phosphoric acid
detergent.
Do not mix S-Klenz (acid descaler) withInterchlor
(chlorine sanitizer) as exothermic reaction will
occur, creating harmful chlorine gas.

Figure 8 *Cage Klenz 100 and S-Klenz are products of Steris Corporation, Mentor,
Ohio, U.S.A.
1 Toigo, J. and Giraud, S., “What’s Growing in Your Heater/Cooler”, Perfusion
Life , 1993;10 (10):18-19. *Interchlor is a product of Intercon Chemical Company, St. Louis, Missouri,
U.S.A.
16
Maintenance
Setup (Continued)
Drain the Unit
• Turn the System Power Off and back On to open the
internal valves. Open both drain valves to empty
tanks.
• Select Standby mode and gravity drain into a floor
drain or bucket, OR
Use Cooldown mode; pump the water through the
drain hose until only 6 in. (15,2 cm) of water remains
in the large tank. Gravity drain the remaining water.
• Close both drain valves.
Sanitization Procedure (daily)
Test the total chlorine level using Chlorine Free
Indicators* or equivalent.
Warning: To control bacteria, maintain chlorine
level between 3 to 5 ppm.
Precaution: To avoid corrosion, do not allow the
chlorine level to exceed 10 ppm.
If chlorine level is below 3-5 ppm:
• Select Defrost; turn the Cardioplegia on with Large to
Small Tank mode and 3 RPM to circulate water.
• Add up to 5 ml of Interchlor to the large tank. Run for
2 minutes.
• Select Rewarm and Small Tank modes; 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 Defrost, with
Cardioplegia on in Large to Small Tank mode and 3
RPM. Run for 2 minutes in Rewarm and Small
Tank modes.
• 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.
Cleaning and Sanitizing Procedure
(minimum weekly)
Clean with Detergent
• Per Setup, close circuits. Fill and prime if necessary.
• Select Defrost; turn the Cardioplegia on with
Large to Small Tank mode and 3 RPM.
• To ≤ 8°C water, add 11 oz. (325,3 ml) of Cage Klenz
100 to the large tank. Run for 5 minutes.
• Select Rewarm and Small Tank modes; run for 5
minutes.
• Per Setup, drain. Wipe any debris from the tanks
and the tank outlet screens. Screens should be
replaced periodically. Do not operate the unit without
screens.
• Per Setup, fill and prime.
Add Chlorine per Sanitization Procedure
• Select Defrost; turn the Cardioplegia on with
Large to Small Tank mode and 3 RPM.
• Add 5 ml of Interchlor to the large tank. Run for 2
minutes.
• Select Rewarm and Small Tank modes; run for 2
minutes.
• Test and adjust the chlorine level until within
prescribed limits.
Clean the Exterior
• Wipe the cabinet with a damp cloth. Keep water
out of the displays, away from the probe jacks, and
away from all switches.
• Use a soft brush or vacuum to remove lint from the
lint filter.
• Clean the writing spaces with a soft eraser. Do not
use any abrasive material.
Make New Ice or Store Unit
• To make new ice, turn the Ice Maker to On. The
Ice Making LED will light but all other LEDs will
be off.
• To store the unit, turn the System Power Off,
disconnect the unit from wall power, drain the unit,
wipe the tanks dry and put the tank covers in place.
Clean the Coils (every 3 months)
Precaution: Remove any lint from the refrigeration
coils to prevent damaging the ice maker. Take care
when cleaning the refrigeration coils as the coils
have sharp edges.
• Disconnect the unit from its wall power supply.
Remove the rear panel and the left rear panel
(corner away from the small tank).
• Use a soft brush and vacuum to remove lint from
the coils.
• Replace the panels. Connect the unit to wall power.
*Chlorine Free is a product of Industrial Test System, Rock Hill, South
Carolina, U.S.A.
17
Maintenance
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.
Do not mix S-Klenz (acid descaler) with Interchlor
(chlorine sanitizer) as exothermic reaction will
occur, creating harmful chlorine gas.
Descale
• Test for chlorine. Remove chlorine prior to
descaling; drain, fill and prime per Setup.
• Select Defrost; turn the Cardioplegia on with Large
to Small Tank mode and 3 RPM.
• To ≤ 8°C water, slowly add 11 oz. (325,3 ml) of
S-Klenz to the large tank; run for 15 minutes.
• Select Rewarm and Small Tank modes; run 15
minutes.
Rinse and Drain
• Per Setup, drain, fill and prime.
• Select Defrost; turn the Cardioplegia on with
Large to Small Tank mode and 3 RPM. Run for 2
minutes.
• Select Rewarm and Small Tank modes; run 2
minutes.
• Drain the rinse water. Wipe any debris from the
tanks and the tank outlet screens. Fill with clean
water and prime.
• Perform complete Cleaning and Sanitizing Procedure.
Decontamination Procedure (when needed)
Decontaminate whenever biofilm is evident, which may
be noticeable by a discoloration or cloudiness in the
external fluid lines.
Prepare
• Descale and Rinse according to the Descaling
Procedure.
• Wipe any debris from the tanks and the tank outlet
screens.
Remove Biofilm
• Add 20-30 lbs. (9,1 - 13,6 kg) of ice to the large
tank (or make a full block of ice); add ice to small
tank.
• Fill tanks and prime.
• Select Defrost; turn the Cardioplegia on with
Large to Small Tank mode and 3 RPM.
18
• To ≤ 8°C water, slowly add 11 oz. (325,3 ml) of
Interchlor sanitizer to the large tank. Run for at
least 1 hour, adding ice if necessary to keep the
water below 20°C.
• Select Rewarm and Small Tank modes. Run for at
least 1 hour.
Note: If biofilm is still visible, continue alternat-
ing between Defrost and Rewarm, running for 1/2
hour at each setting. Keep below 20°C when in
Defrost. 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 Defrost; turn the Cardioplegia on with
Large to Small Tank mode and 3 RPM. Run for 2
minutes.
• Select Rewarm and Small Tank modes. Run for 2
minutes.
• Test the chlorine level and sanitize per Sanitization
Procedure. Replace all external water lines once
the unit is drained.
• Make new ice or store the unit.
Periodic Operator Checks
The following tests may be performed periodically
between the 6 month service checks made by Terumo
Cardiovascular Systems Corporation Service.
Temperature Accuracy
1. Connect the ART water In and Out ports with tubing
to make a closed circuit.
2. Attach a Temperature Probe and a temperature
measuring device to the closed circuit.
3. Set various temperatures; once each temperature is
attained, compare the readings for the Maintain
setting, the water temperature display, and the
measuring device. All temperatures should be
within 1°C of each other.
Operating Modes
1. Set a Maintain temperature of 30°C and begin
Maintain mode; the water temperature display
should stabilize at 30°C.
2. Change to Rewarm mode; the water temperature
should rise.
3. Change to Cooldown mode; the water temperature
should drop.
Maintenance
Cardioplegia Check
Note: The large tank mode and the small tank mode are
both dependent on an external closed loop for water
flow. The large to small tank mode is not dependent on
an external closed loop.
1. Connect the CPG In and Out ports with tubing to
make a closed circuit.
2. Select Large to Small tank mode.
3. Select High Speed. The water should flow full force
from the small tank to the large tank.
4. Check the flow rates at varying speeds. Press the
RPM switch once for low speed, the #1 LED should
illuminate and water should flow from the small
tank to the large tank at a greatly reduced rate.
Press the RPM switch again for medium speed.
The #2 LED should illuminate and the water flow
rate should increase. Press the RPM switch again
for high speed. The #3 LED should illuminate and
the water flow rate should increase to an even
greater speed.
5. Press the large tank switch. The large tank LED
should illuminate and water should continue to flow
from the small tank to the large tank and through
the CPG ports. Momentarily restrict the water flow
through the external loop using a clamp or hands.
The water should stop flowing from the small tank
to the large tank.
H2O > 42°C Warning
1. Operate the unit in Rewarm mode until up to 42°C;
check with a measuring device that the water outlet
temperature remains below 42°C.
2. Add sufficiently hot water to the large tank to
exceed 43°C; check that the H2O > 42°C Warning
LED lights and the alarm sounds.
Low Flow to Blanket Warning
If using the Blanket Supply, select Cooldown, Maintain,
or Rewarm mode and kink the tubing leading to the
blanket In port; within 20 seconds, the Low Flow to
Blanket LED should light. Unkink the tubing and the
LED should go out.
Current Leakage
Maximum current leakage should not exceed 100
microamps for 115V units and 500µA for 220V units
when the unit is in any mode. To measure the current
leakage, refer to Underwriters Laboratory or IEC Stan-
dards for the correct procedure.
Remote Temperature Display Module Checks
Operating Modes
1. Repeat Operating Modes checks using the remote
module
Gradient Modes
1. Insert a temperature probe for Gradient Tempera-
ture into channel G on the Temperature Module and
place the probe in 25°C water.
2. Press the Gradient switch on the main panel once
and set Maintain mode for 40 °C. The gradient 6°
LED should illuminate and the water temperature
display should increase to 31°C (25° plus 6°) and
hold.
3. Press the Gradient switch again. The gradient 6°
LED should extinguish, the gradient 10° LED should
illuminate and the water temperature should
increase to 35°C.
4. Press the Gradient switch again. The gradient 10°
LED should extinguish and the temperature should
continue to increase.
Alarm Limit Accuracy
1. Set a low alarm for 12°C. Test Probes A, B, and C
by placing the probe in ice cold water; the warning
alarm should sound and the probe LED flash.
Remove the probe from the water and the alarm
should stop.
2. Set a high alarm for 30°C. Test Probes A, B, and C
by placing the probe in water which is over 30°C;
the warning alarm should sound and the probe
LED flash. Remove the probe from the water and
the alarm should stop.
Service Checks
It is recommended that the entire system have a mainte-
nance inspection 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 Cardiovascular
Systems Corporation certified service technicians. Any
service or repair by an unauthorized service technician or
use of unapproved parts will void your Terumo Cardiovas-
cular Systems Product Warranty and may increase the risk
of a product failure.
19
Maintenance

Accessories

These accessories are available for use in setting up the Sarns™ TCM II and attached equipment for operation.

146595 Arterial Heat Exchanger Supply Accesssory Kit

146616 Blanket Supply Accesssory Kit

146608 Cardioplegia Water Supply Accessory Kit

146843 Water Supply Cleaning Loop

146851 Cardioplegia Supply Cleaning Loop

15746 Temperature Display Module 15745 Temperature Probe Module

These modules include directions for installation or replacement by a Certified Clinical Engineer, Biomedical Engi-
neer, Biomedical Electrical Technician, or those trained to service Sarns brand equipment.

Temperature Probes
Any YSI (Yellow Springs Instrument) 400 Series Probe.

20
Technical Support

Using this Section

This section provides technical information about the Sarns TCM II; it is intended for Certified
TM

Clinical Engineers, Biomedical Electrical Technicians, and those trained to service Sarns brand
equipment. The information in this section is specific to this device and should not be used for
any other equipment.

Precaution: Only those competent in the areas of electrical and mechanical repair, such
as hospital technicians, may replace those parts designated in this section as
replaceable. More complex repairs may be made only by persons specifically trained and
certified by Terumo Cardiovascular Systems Corporation to work on the Sarns TCM II.
TM

Before making any checks or replacements, read the operating instructions in this manual to
understand the product, safety warnings and equipment precautions, preparation, operation
and maintenance information, and warranty limits.

Contact Terumo Cardiovascular Systems Corporation Service, your local Terumo company or
your authorized Terumo representative when replacing any parts.

After servicing the unit, always check that the unit is operating properly.

Refer to the Performance Specifications for basic information on how the system should
function. Proprietary information has been deleted from the specifications.

Warnings: Before servicing the system, turn off the system power and disconnect the
TCM II system from the wall power source.

Always review the Safety Warnings and Equipment Precautions contained in this manual
before servicing the unit.

21
Technical Support

Specifications
Electrical
Power Supply Catalog Number Catalog Number
4415 4416

Voltage 108-122 VAC 210-250 VAC

(115 V nominal) (220-240 V nominal)
Frequency 60 Hz 50 Hz
Amperage* 16 A 12 A

Current Leakage 100 microamps maximum for 115 V.

500 microamps maximum for 220 V.
Ground Resistance 0.1 Ohm maximum

*Note: SarnsTM TCM II amperage specifications are applicable to normal clinical operating
conditions. Normal clinical operating conditions do not include making ice in Maintain mode
when the water in the large tank is ≥ 20° C.

Dimensions
Main Unit
Height: 34.4 in. (87,4 cm)
Width: 20 in. (50,8 cm)
Depth: 31.5 in. (80,0 cm)
Weight: 282 lbs. (127,9 kg) with the tanks empty
356 lbs. (161,5 kg) with the tanks full

Large Tank Small Tank

Length: 18.5 in. (47,0 cm) 9.5 in. (24,1 cm)
Width: 8.7 in. (22,1 cm) 5.5 in. (14,0 cm)
Depth: 21.5 in. (54,6 cm) 9.3 in. (23,6 cm)
Capacity: Water 9 gal. (34,0 L) 1.2 gal. (4,5 L)
or Crushed Ice 40 lbs. (18,1 kg) 7.5 lbs. (3,4 kg)

Temperature Temperature
Display Unit Probe Modules
Height: 8-3/4 in. (22,2 cm) 9 in. (22,9 cm)
Width: 5-1/2 in. (14,0 cm) 5-3/4 in. (14,6 cm)
Depth: 2-1/2 in. (6,4 cm) 2-1/2 in. (6,4 cm)

22
Technical Support

Specifications (Continued)
Performance
Water Outlet Temperature
Arterial Heat Exchanger and Blanket: 0-42°C.
Cardioplegia: ice water only.

Maximum Flow Performance (1/8 hp Pump)

Arterial Heat Exchanger* outlet port:
5.5 gal/min (21.0 L/Min) at zero head
13.5 psi (698 mmHg) maximum pressure

Blanket Supply* outlet port:

0.8 gal/min (3.0 L/Min) at zero head
11.8 psi (610 mmHg) maximum pressure

Cardioplegia Water Supply port:

2.1 gal/min (7.9 L/Min)
7.5 psi (388 mmHg) maximum pressure

Ice Supply
If the large tank is filled to the maximum level with 25°C water, the Ice Maker can provide a
maximum of 50 lbs (22,7 kg) in 8 hours or 19 lbs. (8,6 kg) in 3 hours.

Temperature Probe Module operating range: 0-50°C

Remote temperature sensing and display accuracy: ± 0.3°C

Venous differential mode:

6° gradient = rewarm water temperature is held to a maximum of 6°C more than the incoming
venous blood temperature.

10° gradient = rewarm water temperature is held to a maximum of 10°C more than the incoming
venous blood temperature.

*Note: Performance will be different with both a heat exchanger and a blanket being supplied water at the same time.

23
Technical Support

EMC Tables
EMC testing was conducted to IEC 60601-1-2 (1993) version. Not all tests for EMC compliance were required at that
time. The EMC tables below are a requirement of the IEC 60601-1-2 (2001) version. Omissions of data in the tables
below are due to this EMC testing difference

Table 201 – Guidance and manufacturer’s declaration – electromagnetic emissions –

for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 3))
Guidance and manufacturer’s declaration – electromagnetic emissions

The Sarns TCM II is intended for use in the electromagnetic environment specified below. The customer or the user of the SarnsTM TCM II
TM

should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The SarnsTM TCM II uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions Class A The SarnsTM TCM II is suitable for use in all establishments, other than
CISPR 11 domestic and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Harmonic emissions Not tested
IEC61000-3-2

Voltage fluctuations/flicker
emissions Not tested
IEC 61000-3-3

Table 202 – Guidance and manufacturer’s declaration – electromagnetic immunity –

for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6))
Guidance and manufacturer’s declaration – electromagnetic emissions

The SarnsTM TCM II is intended for use in the electromagnetic environment specified below. The customer or the user of the SarnsTM TCM II
should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge ± 6 kV Contact ± 3 kV Contact Floors should be wood, concrete or ceramic tile.
(ESD) ± 8 kV air ± 8 kV air If floors are covered with synthetic material, the relative humidity should
IEC 61000-4-2 be at least 30 %.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be that of a typical commercial or hospital
transient/burst supply lines supply lines environment.
IEC 61000-4-4
± 1 kV for Not applicable
input/output lines
Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be that of a typical commercial or hospital
IEC 61000-4-5 line(s) line(s) environment.
± 2 kV line(s) to ± 2 kV line(s) to
earth earth
Voltage dips, short < 5 % UT Not tested Mains power quality should be that of a typical commercial or hospital
interruptions and (> 95 % dip in UT) environment. If the user of the SarnsTM TCM II requires continued operation
voltage variations on for 0,5 cycles during power mains interruptions, it is recommended that the SarnsTM TCM II
power supply lines be powered from an uninteruptible power suply or a battery.
IEC 61000-4-11 40 % UT Not tested
(60 % dip in UT)
for 5 cycles

70 % UT Not tested
(30 % dip in UT)
for 25 cycles

< 5 % UT Not tested

(> 95 % dip in UT)
for 5 sec
Power frequency 3 A/m Not tested Power frequency magnetic fields should be at levels characteristic of a typical
(50/60 Hz) magnetic location in a typical commercial or hospital environment.
field
IEC 61000-4-8

Note: UT is the a.c. mains voltage prior to application of the test level.

24
Technical Support

Table 204 – Guidance and manufacturer’s declaration – electromagnetic immunity –

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 6.8.3.201 b)
Guidance and manufacturer’s declaration – electromagnetic immunity
The SarnsTM TCM II is intended for use in the electromagnetic environment specified below. The customer or the user of the SarnsTM TCM II should
assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the SarnsTM TCM II, including cables, than the
recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms Not tested d = (3,5 / V1) √P

IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 Vrms d = 1,2 √P 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to 2,5 GHz

800 MHz - 1 GHz, d = 2,3 √P 800 MHz to 1GHz

3 Vrms
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters as determined by an electromagnetic
site survey, a should be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked with the following
symbol:

NOTE 1 At 80MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
SarnsTM TCM II is used exceeds the applicable RF compliance level above, the SarnsTM TCM II should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the SarnsTM TCM II.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

25
Technical Support

Table 206 – Recommended separation distances between portable and mobile RF communications equipment and
the EQUIPMENT or SYSTEM – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 6.8.3.201 b)
Recommended separation distances between portable and mobile RF communications equipment and the SarnsTM TCM II
The SarnsTM TCM II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user
of the SarnsTM TCM II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile communications
equipment (transmitters) and the SarnsTM TCM II as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitterm
m

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 1 GHz

Rated maximum output
power of transmitter √
d = (3,5 / V1) P d = 1,2 √P d = 2,3 √P
W
0,01 Not tested 0,12 0,23

0,1 Not tested 0,38 0,73

1 Not tested 1,2 2,3

10 Not tested 3,8 7,3

100 Not tested 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.

26
Technical Support Small

Tank
Large

Tank
Blanket In

Valve
Main Water In

Valve

ICE
Valve

Functional Description Heater

Manifold Main Water Out
Main
Main Unit 0,1 or 2
Pump
Heaters On

The main unit, which supplies water for both blood heat Blanket Out

exchangers and blankets, has five modes of operation.

The Standby mode allows temperature readouts without Figure 11: Maintain Mode
the pump or heaters running. In Cooldown mode (see (Set Temperature Greater Than or
Figure 9) the pump draws through the ice water tank for Equal to Water Temperature)
maximum cooling. In Rewarm mode (see Figure 10)
the pump draws water past the heaters for maximum Small Large Blanket In
warming to 42°C. In Maintain mode (see Figures 11, 12 Tank Tank
and 13) the operator selects a water temperature; water Valve
is drawn either past the heaters or from the ice water Main Water In

tank to attain and maintain the selected temperature. In

ICE
Valve Valve
Defrost mode (see Figure 14) the pump draws water
past the heater and recirculates it through the large Heater
tank. To prevent accidentally defrosting the unit, Defrost Manifold Main Water Out
Main
mode must be entered from Standby mode. In all five Heater Off
Pump
modes the outlet water temperature appears on the
digital display. Blanket Out

Figure 12: Maintain Mode

(Set Temperature Slightly Less
Small Large Blanket In Than Water Temperature)
Tank Tank
Valve
Main Water In
Small Large Blanket In
ICE

Valve Valve Tank Tank

Valve
Main Water In
Heater
ICE

Manifold Main Water Out Valve

Main
Valve
Heaters Off
Pump
Heater
Manifold Main Water Out
Blanket Out
Main
Heater Off Pump
Figure 9: Cooldown Mode
Blanket Out

Figure 13: Maintain Mode

(Set Temperature Much Less Than Water Temperature)
Small Large
Blanket In
Tank Tank
Valve
Main Water In Small Large
Blanket In
Tank Tank
Valve
ICE

Valve
Valve
Main Water In
Valve
Heater
ICE

Manifold Main Water Out Valve

Main
Heaters On
Pump
Heater
Manifold Main Water Out
Blanket Out Main
Heaters On Pump

Figure 10: Rewarm Mode

Blanket Out

Figure 14: Defrost Mode

27
Technical Support

Functional Description (Continued)
The SarnsTM TCM II includes various safety features.
During startup, the unit automatically runs a self test on
the system’s internal functions and opens the valves to
prime the pump. It alerts the operator by sounding an
alarm and lighting warning indicators if it detects
overtemperature of the water, an unprimed pump, low
flow for the blanket or an internal temperature sensor
failure. A system monitor circuit checks for computer
problems; if a problem is detected, the pump heaters
are stopped and the unit attempts to repeat startup.
Figure 16) pumps water from the small tank to external
outlets for use with pressurized-water heat exchangers;
this allows independent cardioplegia cooling. A Large
to Small Tank mode (see Figure 17) recirculates water
from the large to the small tank and back for use with
drop-in heat exchangers.
Small Large
Tank Tank

ICE
The Ice Maker can build at least a 19 lb. (8,6 kg) supply
of ice in 3 hours or an entirely new supply of 50 lbs.
(22,7 kg) in 8 hours starting with 25 °C water. The
Defrost mode will turn off the compressor, defrost until
the water temperature reaches 20°C, and reactivate the
compressor to build an ice supply which is evenly
distributed around the cold plate.
Valve Cardio In
Valve Valve
Cardioplegia Water Supply
The system will provide water to cool clear or blood
cardioplegia. Three pump speeds allow variation of the CPG Cardio Out
Pump
cooling rate of the cardioplegia by changing the water
flow rate. Three water supply modes are available to Figure 16: Small Tank CPG
accommodate different heat exchangers and demands.
A Large Tank mode (see Figure 15) pumps water from
the large tank to external outlets for use with pressur-
ized-water heat exchangers. A Small Tank mode (see
Small Large
Small Large Tank Tank
Tank Tank
ICE
ICE

Valve

Valve

Cardio In
Cardio In
Valve Valve
Valve Valve

CPG Cardio Out

Cardio Out
Pump CPG
Pump

Figure 15: Large Tank CPG Figure 17: Large to Small CPG

28
Technical Support
Functional Description (Continued)
Temperature Display Module
The Temperature Display Module may be used to
monitor the temperature of the patient or extracorporeal
circuit. Temperature probes are connected to a Tem-
perature Probe Module, which is installed in the rear of
the system. One Temperature Probe Module will
translate information from three probes for display on
the three digital displays. Up to nine temperature
readings are available with the use of three Temperature
Probe Modules and nine temperature probes. Probe
Display switches are used to select which probe’s
information will be displayed. LEDs, next to alphabeti-
cally marked labels, indicate which probe has been
selected. These labels have an erasable writing surface
for marking the probe location in the patient or extracor-
poreal circuit. High and low temperature alarm limits
may be set for one probe per module.
Gradient rewarming frees the operator from constant
monitoring and setting of temperatures. When Probe G
is measuring the venous blood temperature, gradient
rewarming may be used to limit the warming rate of
water to 6° or 10° above the temperature of the venous
blood. Selecting a gradient while in Rewarm mode
limits the maximum water temperature to 42°C; select-
ing a gradient while in Maintain mode allows the
operator to select a maximum water temperature lower
than 42°C.
The Temperature Display Module’s remote control
function duplicates the main unit cooling, warming, and
maintain controls and the cardioplegia pump On/Off
switch. The module may be mounted on a vertical pole
up to 7.5 ft. (2,3 m) from the main unit; the remote
controls allow convenient operation of the main unit
while monitoring temperatures.
For safety, the Test switch may be used to check the
temperature conversion circuitry and displays. A
remote monitor circuit automatically checks for internal
problems; it will cause all the panel lights to go off if a
problem is detected.
Theory of Operation
For an arterial heat exchanger or blanket supply, water
is drawn by the pump 1) from a cold water reservoir for
maximum cooling, 2) in a closed path past electric
heaters for maximum warming, or 3) in a path with
either cold reservoir water added or heat added to attain
and maintain a set temperature. Microprocessors
translate and compare thermistor probe measurements
to the selected temperature; then they operate the
correct valves and electric heaters to adjust the water
temperature. The microprocessors also translate the
probe measurements for digital display.
When a gradient relative to the venous blood tempera-
ture is used for rewarming, microprocessors measure
the difference between venous blood temperature and
water temperature and control the valves and heaters to
maintain the correct differential.
The SarnsTM TCM II is designed to provide protection
against excessively high temperatures. The maximum
temperature available for operator selection is limited to
42°C. The software compares the primary and redun-
dant temperature probes in the heaters to verify tem-
perature accuracy; the software will give an alarm and
shut off the heaters if the temperature reaches
42.5 °C. In the event of software failure, a completely
separate monitoring system with an emergency circuit
will shut off the heaters at 43.0°C.
The ice maker is a compressor type refrigeration system
which uses refrigerant gas mixture (R-404a). The water
freezes onto a cold plate located in the large tank. A
sensor, near the cold plate, turns off the compressor
when approximately 50 lbs. (22,7 kg) of ice has col-
lected. The microprocessor disables the compressor
when in Defrost mode.
For Cardioplegia Water Supply, water is 1) drawn by a
pump from a water reservoir, supplied to an external
port, and returned; or 2) drawn from the large water
reservoir, supplied to a small water reservoir, and
returned to the large reservoir. The pump operates at
three speeds to change the water flow rate. The mode
and speed selections are activated by the cardioplegia
switch.
For patient temperature monitoring, a thermistor, at the
tip of each telethermometer probe, senses external
temperature. When there is a shift in the external
temperature, the electrical resistance of the thermistor
changes accordingly. This resistance change is mea-
sured by the Temperature Probe Modules, and transmit-
ted for display.
The remote controls function in the same manner as
their counterparts on the main unit. Choosing a mode
on the remote panel causes the appropriate information
to be sent to the main unit. The main unit acknowl-
edges receiving the information by returning the
information to the remote unit and lighting the correct
remote LED. The display of the LEDs on the remote unit
indicates the change has been received on the main
panel.
29
Technical Support

Hydraulic Block Diagram

Compressor Block Diagram

30
Technical Support

Symbol Key

Symbol Description

Attention, see instructions for use.

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

Indication of degree of protection against electric shock, Type BF.

Date of manufacture, year expressed in 4 digits.

Indicates compliance with European Medical Device Directive (EMDD) and denotes the Notified
0197
Body by identity number.

S
Indicates compliance with YY91047 and GB9706.1

Indicates participation in third party recycling system established in Germany under auspices
of German Waste Packaging legislation.

Indicates compliance with Directive 2002/96/EC.

ON, circuit closed.

OFF, circuit open.

Ice Maker Switch, Ice making indicator.

Pump not primed.

31
Technical Support

Symbol Key (Continued)

Symbol Description

Low Flow to Blanket

Service.

Defrost

Standby

Cooldown

Maintain

Rewarm

Large Tank Switch

Small Tank Switch

Large to Small Switch

32
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 damaged by improper use, accident, improper maintenance or unautho-
rized 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 Service, 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 Sys-
tems Corporation:
Telephone: (734) 663-4145
Facsimile: (734) 741-6449

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

33
 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. 802014 R/B

© TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 2005 December, 2005