3M Sarns TCM II User manual

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TERUMO 1005
Sarnsm
TCM II
OperatOrs Manual
System Software Version 2.0
Remote Software Version A 3M Health C are
1 TERUMO 1005

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Sarnsw
TCM II
Operators Manual
4415 115 v with Cardioplegia (3M ID. No. 98—0702-0629-1)
4416 220-240 V with Cardioplegia (3M ID. No. 98-0702-0627-5)
Cautions
Caution: FEDERAL UJ.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 profession.
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 instruc~
tions that may be subsequently issued.
Service Policy
Contact Sarns Service, your local 3M subsidiary or your authorized Sarns distributor and
describe the problem before attempting to service or return this device. Instructions will then be
given for correcting the problem or returning the device and a Returned Goods (RG) number
will be issued,
Returned devices must be packaged with adequate protection against shipping damage. Include a
note describing theproblem, stating the RG number, and giving the name, address, and tele-
phone number of a person to contact for additional information.
In the United States, contact the Sarns Service Department:
Sarns
3M Health Care
6200 Jackson Road
Ann Arbor, Michigan 48103 USA.
Telephone: (800) 521—281 8
Telex: 4930455 SARSVC
Outside the United States, please contact your local 3M subsidiary, your authorized Sarns
distributor or the International Department at Sarns.
Telephone: [phone]
Telex: 4930456 SARINC
Facsimile: [phone]

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Table of Contents
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Product Definition
Description
Indications
Contraindications
Warnings
Precautions
Controls And Displays
Main Unit
Cardioplegia Water Supply
Temperature DisplayModule
Preparation
Checking Ice And Water
Connecting Equipment
Starting And Priming The System
Operation
Using The System
Resolving Alarm Conditions
Correcting Equipment Problems
Using The Ice Maker
Maintenance
Setup
Sanitization Procedure
Cleaning and Sanitizing Procedure
Clean the Coils
Descaling Procedure
Decontamination Procedure
Periodic Operator Checks
Sarns Service Checks
Accessories
Inspection And Repair Record
Product Description
Specifications
Functional Description
Theory Of Operation

4

5
Product Definition
Description
The SarnsTM TCM ll (system) is a source of tempera-
tum-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 prac—
tices.
The SarnsTM TCM H 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 detergents
Do not mix S-AKlenz (acid descaler) with the Process
LCS (chlorine sanitizer) as exothermic reaction will
occur, creating harmful chlorine gas.
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 11 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.
Use only Cage Klenz [00, Process LCS and S—Klenz as
cleaning agents, following the manufacturer’s direc-
tions and safety precautions.* Do not exceed the
recommended strength to prevent corrosion damage.
To avoid corrosion, do not allow the chlorine level to
exceed 10 ppm.
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 Foranc (isofluoranc) 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.
‘Cage Klee: 100. Process LCS and S-Klenz are products of Calgon Vestal
Laboratories. St. Louis. Missmri, U.S.A.

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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.
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 offas needed to make and maintain
an ice block.

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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.
E
-
STANDBY CDDLDOWN
|
ICE MAKING
GRADIENT
- -
A6“ _\10’
CAR DIOPLEGIA
H20 ‘C
H.
Figure 2: Front Panel
ICE NIAKING Indicator Lamp fights when the ice
making fimction is active.
Water Temperature Display shows the output water
temperature
Cardioplegia Water Switch allows momentary display
of the cardiopleg'ia outlet water temperature on the Water
Temperature display.
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).
COOLDOWN (Mode) Switch opens valves to circulate
cold Water from the large tank.
MAINTAIN (Mode) Switch begins warming water or
adding cold Water to attain and maintain an operator—
selected temperature.
Maintain Temperature Display shows the selected
maintain temperature. During startup, this display shows
the software version and then 25°C.
MAINTAIN TEMPERATURE Switches raise or lower
the maintain temperature setting within a range of
O“-42"C.
REWARM (M ode) Switch activates the heaters to warm
water at a maximum rate up to 42°C and circulates the
warm water.
J. Gradient Switch limits the water temperature in Maintain
or Rewarrn 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 rewarrn 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. H10 > 42°C LED lights to warn that the water tempera—
ture is at or above 425°C. The heaters are automatically
turned off. The light and bumer 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.
0. Service LED lights to warn that the temperature display
and temperature control m be malfunctioning.

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Controls and Displays
Cardioplegia Water Supply
1 2 3 - - -
I I I LARGE SMALL LARGE To
use RPM TANK TANK SMALL
mg @@Q
j 7” ”2/ 7L 9L
Figure 3: Cardioplegia Panel
A. Cardioplegia Switch (CPG) starts or stops the D. SMALL TANK Switch sets the system to deliver
water Circulating pump. Flow parameters are water from the small tank to the cardioplegia water
determined by the speed and water circuit selected. outlet.
B. Speed Switch (RPM) selects the cardioplegia E. LARGE T0 SMALL Switch sets the system to
pump Speed. LED l lights for low speed, LED 2 recirculate water from the large tank to the small
lights for medium speed, and LED 3 lights for high tank.
speed.
To display the water temperature, use the Cardioplegia
C. LARGE TANK Switch sets the system to deliver Water switch on the main panel.
water from the large tank to the curdioplegia water
outlet.

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Controls and Displays
Temperature Display Module C. Probe LED lights to identify which probe’s information
is being displayed.The LEDs for Probes A, B, or C also
flash to indicate alarms. lithe alarm limits for two
probes are exceeded, both probe LEDs will flash; if one
of these probes is also selected for display, its LED will
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.”
h‘. 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.
IIEDMPLEBM
o
P. 'l‘ES’l' Switch initiates a test to verify that the Temperav
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 ‘
Figure 4: Module Panel pertains to the last Temperature Probe Module. When
the test switch is depressed, the display must indicate
25 :t: .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.
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 Status” 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.
The remote control switches firnction in the same manner as
their counterparts on the main unit.
A. Probe Display Switch selects which probe’s
information will be displayed. Selections are
marked on the switch. The probe LED lights to
indicate the probe selected.
B. Temperature Display shows the probe tempera-
ture and the following information:
--- Indicates that there is no probe connected
or that the temperature is below -.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.
The top display also displays the selection range and
settings for the temperature limit alarms.

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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).
Figure 5: Water Connections
Connect the Display Module (Figure 6)
Select any 1 5/8 in.(4,l 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
.v’—\
‘ ‘ 1 . desired position; tighten the thumbscrew (B). Position
3- A1130}! the water fittings (C) to the tubing SGCUODS the back of the module so that its slot is directly over
and secure the connection with tubing clamps (D). the desired support tab (C); pull the module downward
until it is securely on the tab.
4. Attach the tubing sections to the heat exchangers
and blanket. Connect the Temperature Display Module to the main
unit before the System Power is turned on. Insert the
5. Insert the water fittings into the appropriate In and module plug into the socket which is located in the
Out ports on the system: CPG H20 for the pocket on the main unit. Be sure that this plug is
cardioplegia heat exchanger, ART H20 for the securely connected,
arterial heat exchanger, and BKT H20 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 6: Bracket
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