3M Sarns TCM II User manual

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

2
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]

3
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.

6
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.

7
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.

8
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.

9
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.

10
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
10
10

11
Preparation
Connect the Probes Starting and Priming the System
Start the Unit
1. See that the Ice Maker and System Power switches
are off.
Warning: To obtain accurate temperature
readings, use only probes specified by Sarns for
use with the Temperature Probe Module.
2. Plug the power cord into a wall outlet of proper
Insert the temperature probes into the sockets on the :1? ltaggefr??in?§ and capacrty as indicated on
back of the system (see Figure 7). Each letter, A, D, G, a na p a e a '
etc, corresponds to a Probe Label on the remote unit. 3. Turn the System Power and Ice Maker on.
Write the intended use of the probe on the correspond-
ing Probe Label. Do not use permanent ink markers or Check the Startup Conditions
coloring pens as they can stain the writing surface. 1. During the self test period, check that:
Use a mild solvent or soft eraser to remove markings. - 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.
Figure 7: Temperature Probe Modules
3. Before priming attached equipment, check that:
Note: When rewarming to a gradient, Probe G must ' The water level is up to the maximum level.
measure venous blood temperature. - 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 offfor 2 seconds, then back on, and
check again. If they are still incorrect, do not use the
equipment; contact Sarns Service, your local 3M
subsidiary or your authorized Sarns distributor.
11
11

12
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 disap—
pear. 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).
12
Test the Temperature Probe Modules
Depress the TEST switch; the displays must read
25” i .4°C. If the readings fall outside this range,
contact Sarns 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 [or 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 Sarns Service, your local
3M subsidiary or your authorized Sarns distributor.
12
,fi\_

13
Operation
Using the System
\Varnings: It is the operator’s responsibility to
use the SarnsTM TCM II and any attached equip-
ment according to the manufacturer’s instructions
and good medical practices.
The SarnsT'v 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 (particu-
larly 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
13
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 Rewanning to control the rate of
rewarm. Select a gradient of6° or 10" on the main
panel. Check that Probe G is measuring the venous
blood temperature. 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 flirtation; 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. 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 perfor-
mance (see maximum—minimum label).

14
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 Sarns Service, your local 3M subsidiary or your authorized Sarns 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
H20 > 42°C Warning
Pump Not Primed Warning
Low Flow to Blanket Warning
Service Warning
Recurrence of Startup
Temperature Display Module
panel blank due to problem with
the module
14
Procedure
Switch to Cooldown mode until the water temperature reaches a satisfactory level:
the warning LED will go out and the buzzer wilt 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 degrees until the additional
equipment is attached.
It 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 Flewarm to complete priming the system. Reset
the controls and continue using the unit.
Check for leaks, kinks, or blockage in the tubing for the blanket.
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 SarnsTM TCM II or to change to an alternate source of water,
Check the startup conditions are correct. Reset controls; continue using the unit.
Unplug the remote from the main. Gradient rewarming may be continued although
the venous blood temperature will not be displayed.
14
ii

15
Operation
Correcting Equipment Problems
Slow or no water flow.
Slow or no cooldown.
Exce53ive noise.
Compressor not running.
Check:
' Water supply. Priming requires water up to the fill line of the large tank.
- Outlct 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.
0 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 about
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:
a 4 minute delay after the switch is depressed before the compressor
turns on.
Check:
- Entry mode. Entry to Defrost modc 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.
- Probelabels 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 OE 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 Sarns Service, your local 3M
subsidiary or your authorized Sarns distributor.
15
15

16
Operation
Using the Ice Maker
Up to ten hours before use:
1.
16
Remove any attached equipment. Turn the System
Power and Ice Maker On.
Use the Defrost mode to melt the ice of 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.
When the water temperature reaches 20°C, the unit
will automatically go into Standby mode. After
about a 4 minute delay, the compressor will turn
on.
Turn the System Power off once the compressor
has started. Leave the Ice Maker On; the ice
sensor will automatically turn the compressor of
when an adequate amount of ice is made.
Check the ice block. A large block of ice should
be formed around the cold plate. lce should
surround 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.
Icc 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:
1.
2.
3.
16
Note: Defrost is not necessary when an operator is
monitoring the ice maker.
Turn the Ice Maker On and selcct Standby mode.
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.
Check to see the sensor has turned the compressor
of when an adequate supply of ice is made.

17
Frequency Maintenance Procedures Duration
Daily Sanitlze (Test Chlorine) 5 min
Weekly Clean and Sanitize 30 min
Every 3 Months Clean coils 20 min
Every 6 Months Descale 1 hour
For excessive biofilm Decontaminate (which descales, 2-6 hours
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 biofilrn may form,
requiring a prolonged decontamination procedure. The
descaling procedure reduces hard water deposits from
affecting the operating efficiency and safety of the
unit.
Setup (Detailed Steps Used Throughout Mainte-
nance 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
5:529 HIV-Ii:
WARNING: KEEP CLOSED
UNLtSS DHAlNING.
Figure 8
17
- Connect each set of In and Out ports with about
2 ft. (0,6 m) of tubing; include a ball type valve
and drainage line in the cardioplegia and arterial
water circuits.
~ Position the unit near a sink or floor drain.
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 rnode until the air bubbles disappear.
Then alternate between Cooldown and Rewarrn
modes until the unitwill operate in Rewann 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 1 00, Process LCS and
S-Klenz 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) with the
Process LCS (chlorine sanitizer) as exothermic
reaction will occur, creating harmful chlorine gas.
I Toigo. J. and Giraud. 5., “What’s Growlng in Your | leater/Cooler". Permian
Life.1995:10(10):18—19.
‘Cage Klenz 100, Process LCS and S-KIenz are products of Calgon Vestal
Laboratorles. St. _OUIs, Missouri, U.S.A.
17

18
Maintenance
Setup (Continued)
Drain the Unit
Turn the System Power Off and back On to open the
intemal 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 Water-ChairTM Indica-
tors* or equivalent.
l
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:
v
Select Defrost; turn the Cardioplegia on with Large
to Small Tank mode and 3 RPM to circulate water.
Add up to 5 ml of Process LCS 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 Rewarrn 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
Process LCS per above directions.
Cleaning and Sanitizing Procedure
(minimum weekly)
Clean with Detergent
18
Per Setup, closc circuits. Fill and prime if necessary.
Select Defrost; turn the Cardioplegia on with
large to Small Tank mode and 3 RPM.
. To 5 8°C water, add 11 oz. of Cage Klertz 100 to
the large tank (11 oz. equals eleven pumps from
the l 02. dispenser). 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 Cai’dioplegia on with
Large to Small Tank mode and 3 RPM.
- Add 5 ml of Process LCS 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 refrigera—
tion 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
'WatenChex is a trademark of A11. Division of PyMaH Corporation.
18

19
Maintenance
Descallng 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 the
Process LCS (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 Cardioplcgia on with
Large to Small Tank mode and 3 RPM.
- To _<_ 8°C water, slowly add 11 oz. of S—chnz to the
large tank (eleven pumps of the 1 oz. dispenser);
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 Proce—
dure.
19
_———______————_W1
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.
‘ Clean (without filling or sanitizing) according to
Cleaning and Sanitizing Procedure.
Remove Biofilm
- Add 20-30 lbs. 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.
- To S 8“C water, slowly add [1 oz. of Process LCS
sanitizer to the large tank (eleven pumps from the
1 oz. dispenser). Run for at least 1 hour, adding
ice if necessary to keep the water below 20°C.
- Select Rewarrn and Small Tank modes. Run for at
least 1 hour.
Note: If biofilm is still visible, continue alternat-
ing between Defrost and Rewarrn, 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.
19

20
Maintenance
Periodic Operator Checks
The following tests may be performed periodically
between the 6 month service checks made by Sarns
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.
H20 > 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 H20 > 42°C Warning
LED lights and the alarm sounds.
20
Low Flow to Blanket Warning
If using the Blanket Supply, select Cooldown, Main-
tain, 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 when the unit is in any mode. To measure
the current leakage, refer to Underwriters Laboratory
or IEC Standards for the correct procedure.
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.
Sarns Service Checks
It is recommended that the entire system have a
maintenance inspection every six months to ensure
proper operation. Maintenance inspections and repairs
are to be conducted only by Sarns Service, your local
3M subsidiary or your authorized Sarns distributor.
20