Cincinnati Sub-Zero Products, LLC BLANKETROL III 233 User manual

Operation Manual
Model 233 Hyper-Hypothermia System
Cincinnati Sub-Zero Products, LLC 12011 Mosteller Road Cincinnati, Ohio 45241, U.S.A.
www.cszmedical.com
BLANKETROL®is a registered trademark of Cincinnati Sub-Zero Products, LLC, Cincinnati, Ohio USA
Copyright 2018, Cincinnati Sub-Zero Products, LLC All rights reserved.
Manual 57201 Rev. Z
ECN: M1807-5495

OPERATION MANUAL BLANKETROL III, Model 233
Page 1 of 41
TECHNICAL HELP
United States and Canada Telephone [phone]
Cincinnati Sub-Zero Products, LLC (U.S.) Toll Free 1-800-989-7373
12011 Mosteller Road (U.S.) 24hr Clinical Support 1-513-460-2038
Cincinnati, OH 45241 Fax [phone]
www.cszmedical.com
AUTHORIZED EUROPEAN REPRESENTATIVE:
CEpartner4U, BV
Esdoornlaan 13
3951 DB Maarn
The Netherlands
www.CEpartner4U.com
BEFORE YOU CALL FOR SERVICE...
To help us better serve you, please have the serial number of your BLANKETROL III unit ready when you call for parts or service.
The serial number is located on a specification label attached to the unit’s rear panel.
How to read serial numbers:
Example: 121-3-60000
12 indicates a manufacturing date of the year 2012
1 indicates the quarter (first)
-3- means BLANKETROL III, Model 233
60000 indicates that this is the 60,000th unit of a certain model
IN-WARRANTY REPAIR AND PARTS
All parts on your BLANKETROL III unit are covered by a two-year (2) warranty. Additional third year warranty is available at the time
of purchase. To return defective parts or units, first obtain a Returned Materials Authorization (RMA) number from our Medical
Technical Service department. All returns should be made using CSZ-issued shipping cartons.
IMPORTANT SAFETY INFORMATION
Refer to this manual for instructions and operator information. Read and understand all WARNINGS / CAUTIONS before using,
prescribing, or servicing the BLANKETROL III System

OPERATION MANUAL BLANKETROL III, Model 233
Page 2 of 41
TABLE OF CONTENTS
TECHNICAL HELP………………………………………………………………………………………………………………………………….1
BEFORE YOU CALL FOR SERVICE..............................................................................................................................................1
IN-WARRANTY REPAIRAND PARTS...........................................................................................................................................1
IMPORTANT SAFETY INFORMATION .............................................................................................................................................. 1
SYMBOL DEFINITIONS…………………………………………………………………………………………………………………………… 4
WARNINGS AND CAUTIONS…………………………………………………………………………………………………………………….. 5
SECTION 1. INTRODUCTION ........................................................................................................................................................... 8
1-0. GENERALSAFETY PRECAUTIONS .............................................................................................................................8
1-1. GENERAL DESCRIPTION OF THE BLANKETROL III SYSTEM.....................................................................................8
1-2. PHYSICAL DESCRIPTION OF THE BLANKETROL III UNIT ..........................................................................................8
1-2.1. EXTERNAL FEATURES -FRONT VIEW ...............................................................................................................................9
1-2.2. EXTERNAL FEATURES –RIGHT SIDE VIEW .....................................................................................................................10
1-2.3. EXTERNAL FEATURES –REAR VIEW .............................................................................................................................. 11
1-2.4. DESCRIPTION OF THE BLANKETROL III MEMBRANE CONTROL PANEL............................................................................ 12
1-3. REQUIREDACCESSORIES........................................................................................................................................ 13
1-4. USB PORT OPERATION..............................................................................................................................................13
SECTION 2. GENERAL PREPARATION OF THE BLANKETROL III SYSTEM …………………………………………………………14
2-1. INTRODUCTION.......................................................................................................................................................... 14
2-2. UNPACKING THE SHIPMENT..................................................................................................................................... 14
2-3. FIRSTTIME SET-UP/SYSTEM TEST ROUTINE.......................................................................................................... 14
2-3.1. INSPECTING AND ARRANGING THE EQUIPMENT ............................................................................................................... 14
2-3.2. COMPLETING A SYSTEM TEST ROUTINE ......................................................................................................................... 15
2-4. UNIT AND PATIENT RELATED PRECAUTIONS..........................................................................................................15
2-5. PATIENT PREPARATION AND BEDSIDE CARE......................................................................................................... 15
SECTION 3. OPERATING THE BLANKETROL III SYSTEM........................................................................................................... 16
3-1. INTRODUCTION.......................................................................................................................................................... 16
3-2. ARRANGING THE SYSTEM COMPONENTS............................................................................................................... 16
3-3. OPERATINGTHE BLANKETROLIII SYSTEM IN AUTO CONTROLMODE ................................................................. 18
3-4. OPERATINGTHE BLANKETROLIII SYSTEM IN MANUAL CONTROL MODE ............................................................ 19
3-5. OPERATINGTHE BLANKETROLIII SYSTEM IN MANUAL CONTROL MODEWITH THE ADDITIONOF THE
PATIENT PROBE......................................................................................................................................................... 21
3-6. OPERATINGTHE BLANKETROLIII SYSTEM IN GRADIENT 10C MODE.................................................................... 22
3-7. OPERATINGTHE BLANKETROLIII UNIT IN GRADIENT 10C SMART MODE............................................................. 23
3-8. OPERATINGTHE BLANKETROLIII SYSTEM IN GRADIENT VARIABLE MODE......................................................... 25
3-9. OPERATINGTHE BLANKETROLIII SYSTEM IN GRADIENT VARIABLE SMART MODE............................................27
3-10. OPERATING THE BLANKETROLIII SYSTEM IN MONITOR ONLY MODE ................................................................. 28
3-11. CONCLUDING HYPER-HYPOTHERMIA TREATMENT .............................................................................................. 29
3-12. STATUS DISPLAY MESSAGES ..................................................................................................................................30
SECTION 4. GENERAL MAINTENANCE OF THE BLANKETROL III SYSTEM.............................................................................. 34
4-1. INTRODUCTION.......................................................................................................................................................... 34
4-2. MAINTENANCE OF THE BLANKETROL III EXTERIOR –CLEANING INSTRUCTIONS............................................... 34
4-3. MAINTENANCE OF THEWATERRESERVOIR........................................................................................................... 34
4-3.1 REPLENISHING THE RESERVOIR ....................................................................................................................................34
4-4. MAINTENANCE OF THE HYPER-HYPOTHERMIA BLANKETS................................................................................... 34
4-4.1 REUSABLE BLANKETS .................................................................................................................................................. 34
4-4.2 DISPOSABLE,SINGLE-PATIENT USE BLANKETS ...............................................................................................................35
4-5. MAINTENANCE OF REUSABLE THERMISTOR PROBES........................................................................................... 35
4-6. DISPOSAL OF THE BLANKETROL UNIT………………………………………………………………………………………....35
SECTION 5. SPECIFICATIONS AND CERTIFICATIONS OF THE BLANKETROL III..................................................................... 36
WORLDWIDE ORDER PLACEMENT............................................................................................................................................... 40

OPERATION MANUAL BLANKETROL III, Model 233
Page 3 of 41
FIGURES AND TABLES
FIGURE 1-1. BLANKETROL III - FRONT VIEW…………………………………………………………………………………………..9
FIGURE 1-2. BLANKETROL III - RIGHT SIDE VIEW…………………………………………………………………………………….10
FIGURE 1-3. BLANKETROL III - REAR VIEW…………………………………………………………………………………………….11
FIGURE 1-4.A. BLANKETROL III - MEMBRANE CONTROL PANEL (English).................................................................................12
FIGURE 1-4.B. BLANKETROL III - MEMBRANE CONTROL PANEL (Symbols)............................................................................... 13
TABLE 5-1. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMMISSIONS........................... 38
TABLE 5-2. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY.............................. 38
TABLE 5-3. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY.............................. 39
TABLE 5-4. RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS
EQUIPMENT AND THE BLANKETROL III, MODEL 233........................................................................................... 40

OPERATION MANUAL BLANKETROL III, Model 233
Page 4 of 41

Water
Temperature
Silence
Alarm
Temperature Set
Risk of Explosion:
Do not use in the
Presence of Flammable
Anesthetics
Danger; Risk of
Electric Shock
Disconnect Power
Before Servicing
Patient
Temperature
Test Indicators
Monitor
Only
10C
Gradient 10˚ C
V
Gradient
Variable
Water Flow
Indicator
Fill to Strainer
Outlet
Inlet
Low Water
Level
Power Failure
Symbol
Definitions
Read Operation
Instructions and Manual
Before Operating
Separate Disposal for
Electrical / Electronic
Equipment
Power Cord
Holder
Type BF
Equipment
ESD
Susceptibility
OFF / ON Switch
O / I
AC Voltage
~
Equipotential
Symbol
USB Port: Insert Port
in This Direction
Automatic
Control
Manual
Control
5C
Smart
Mode
INCREMENT
(Increase
Temperature)
DECREMENT
(Decrease
Temperature)
OFF/ON
OFF / ON Switch

OPERATION MANUAL BLANKETROL III, Model 233
Page 5 of 41
BLANKETROL®III
OPERATION MANUAL
Cincinnati-Sub-Zero Products, LLC reserves the right to make equipment changes and improvements, which
may not be reflected in this manual.
WARNING
A physician's order is required for setting blanket temperature and use of equipment. At least every 20 minutes, or as directed by
physician, check patient's temperature and skin integrity of areas incontact with blanket; also, check the BLANKETROL III’s water
temperature. Pediatric patients, temperature-sensitive patients with vascular disease, surgical patients, diabetics and patients with
Raynaud’s Disease should be checked more frequently. Notify the physician promptly of any change in patient status in order
to avoid serious injury or death.
The method of temperaturecontrol provided by all hyper-hypothermia units presents the danger of heating or cooling body tissues,
particularly the skin, to a point where they are injured, i.e., burns or frostbite, respectively. Depending on the extent and severity
of a burn, very serious and even fatal complications may arise.
Do not use the BLANKETROL III System distal to arterial cross clamping. Thermal injury may result.
Thermal injury may occur if heating/cooling therapy is applied to ischemic limbs.
The warming of transdermal medications (patches) can increase drug delivery, resulting in possible injury to the patient.
Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over bony prominences. Failure to do so may
result in tissue injury.
Do not place additional heat sources between the patient and blanket. Tissue damage may result.
Means to maintaincontact between the patient andthe blanket during therapy may be required and should not block the fluid
pathways of the blanket or connecting hose. Failure to do so mayresult in inadequate treatment.
Prep solutions have been reported to injure the skin when allowed to remain between patients and a water-circulating heating
blanket during prolonged procedures. Use of materials of good thermal conductivity, such as water, gel, and similar
substances, with the BLANKETROL III not switched ON may decrease the temperature of the patient. The area between the
patient and the blanket should be kept dry to avoid injury to patient.
Propersanitation procedures must be practiced and hygienic safety must be maintained, to prevent contamination.Contamination
can affect patient’s health, i.e. skin irritation/rash may result.
Use only YSI 400 Series, or equivalent, probes on CSZ equipment. Failure to do this will causeincorrect temperature readings
and mayresult in inadequate/inappropriate treatment.
Due to static electricity, a 400 Series Probe may not be connected to the BLANKETROL III unit without first discharging one’s
body to the frame of the BLANKETROL III unit or another grounded object. Failure to do somayresult in damage from
electrostatic discharge (ESD). All staff that may touch the 400 Series Probemust be familiar with this warning and basic static
electricity or electrostatic discharge (ESD) training.
Basic static electricity or ESD training should include an introduction to the physics of electrostaticcharge, the voltage levels that can
occur in normal practice and the damage that can be doneto electronic components if equipment is touched by an operator who is
electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge, and how
and why to discharge one’s body to the BLANKETROLIII unit or another grounded object. Failure to do so mayresult in damage
from electrostatic discharge (ESD).
Do not use the BLANKETROLIII system in the presence of flammable anesthetics. Risk of explosion can result.
Power interruption will cause the BLANKETROL III to revert to CHECK SET POINT resulting in no therapy to the patient. Follow
instructions for desired mode to resume operation. Failure to resume therapycould result in serious injuryor death.
Do not by-pass ground lug (230V System). Electrical Hazards may result.
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Risk of
electrical shock may occur.
Blanket punctures can result in an increased risk of infection or electrical shock. Inspect all blankets for mechanical
damage before use. Do not use in proximity to sharp objects.
Any time water is found leaking into or around the unit, connecting hose, and/or blanket, turn the unit off, disconnect the power
cord from its power source, and correct the problem before proceeding. Proper maintenance procedures should be followed
including, but not limited to, the preventative maintenance described in this manual. Leaky blankets or hoses should never be
used. Water leaks could present a slip hazard and risk of infection and could lead to electric shock.

OPERATION MANUAL BLANKETROL III, Model 233
Page 6 of 41
WARNING
Exercise extreme caution if the BLANKETROL III System is used on patients with cardiac issues, for example, patients with
pacemakers, or when a probe is inserted in or attached to the patient. Failure to properly monitor patient may result in
serious injury or death.
Due to electromagnetic compatibility, the BLANKETROL III unit should not be used adjacent to or stacked with other
equipment. Potential electromagnetic interference may result. Other equipment includes ventilators, patient monitors,
anesthesia delivery equipment, etc. Electromagnetic interference refers to electronic devices unintentionally affecting the
operation of each other by emitting electromagnetic energy. Unit complies with IEC 60601-1-2.
If the BLANKETROL III unit or the other equipment is not operating normally, remove the device from service and have a
biomedical or service technician observe the device in operation. Refer to Section 5 for recommended separation distances
between other equipment and the BLANKETROL III. Failure to do so mayresult in damage to the BLANKETROL III system
and patient injury.
Always unplug the unit before accessing internal components during service. Failure to unplug the unit could result in
electric shock.
The repair, calibration, and servicing of the BLANKETROL III should be performed by qualified Medical Equipment Service
Technicians, Certified Biomedical Electronics Technicians, or Certified Clinical Engineers familiar with good repair practices for
servicingmedical devices, and in accordance with instructions contained in this manual. Improper repair can result in damage
to the BLANKETROL III system and patient injury.
No modification of this equipment is allowed without prior, written authorization from CSZ. Failure to do so mayresult in damage
to the BLANKETROL III system and patient injury.
Before returning the BLANKETROL III to patient use after repairs, the FIRST TIME SET-UP/SYSTEMTEST ROUTINE inSection
2 must always be performed. Improper repair and inadequate maintenance can result in damage to the BLANKETROL III
system and patient injury.
Remove the BLANKETROL III fromservice if the outer casing ormembrane control panel is cracked or internal components are
exposed. Contact with internal components could result in electric shock or thermal injury to the patient or operator and
exposure to sharp edges.
Keep grill and condenser clean and free of debris and obstruction. Blockage of the grill and condenser could result in the unit
overheating which could render the unit unable to provide adequate therapyand excessive surfacetemperatures could
cause injury of patient or operator. Keep unit, specifically the grill away from curtains or other obstructions.
The USB connection on the BLANKETROL III unit is intended for data transfer to a computer. Any other uses/connections may
result in damage to the BLANKETROL III unit.
Working with electronic boards, plugs, and cables requires delicate handling. Proper electrostatic discharge (ESD) procedures
should befollowed during replacement of any electronic board. Failure to do so may resultin damage to theboard.
Use of accessories other than those specified in the Operation and Technical Manual mayresult inincreased
electromagnetic emissionsor decreased immunityto electromagnetic emissions of the BLANKETROL III unit. This could
affect the BLANKETROL III’s compatibility with other electrical equipment. Electromagnetic compatibility refers to electronic
devices unintentionally affecting the operation of each other by emitting electromagnetic energy.

OPERATION MANUAL BLANKETROL III, Model 233
Page 7 of 41
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
Use distilled water only. Do NotUse De-Ionized water. De-Ionized water may cause corrosion to plumbing system
components. Do Not Use TapWater. Minerals and deposits can clog plumbing system components.
Do not use alcohol. Alcoholmay cause blanket and unit deterioration.
Use only hospital grade plug or electric shock may result.
Do not overfill. Overfilling may result in overflow when the water in the blanket drains back into the system when the system is
turned off.
Always drain the BLANKETROLIII to a sanitary drain because bio-contaminants may be present in the unit’s water supply.
Handling or use of the patient probe may result in damage from electrostatic discharge (ESD) if proper precautions are not taken.
All wire-lead, patient-connected transducer assemblies are subject to reading error, local heating, and possible damage from high
intensity sources of RF energy. Inadequately grounded electrosurgical equipment represents one such source, since capacitively
coupled currents may seek alternate paths to ground through probe cables and associated instruments. Patient burns may result. If
possible, remove the probe from patient contact before activating an electrosurgical unit.
Do not immerse probes or connecting cables in liquid. Failure to do somay result in damage to the probes.
If the unit was shipped on its side, permit the unitto rest in an upright position for twelve (12) hours before operating due to
refrigeration oil displacement.
For safe handling and use of chemicals follow manufacturer guidelines.
Do not make any connection tothe USB port terminal whilethe device is also connected to a patient. Do not touch this connector
and the patient at the same time. Patient injurymay result.
Users should not use cleaning or decontamination methods different from those recommended by CSZ without first checking with
CSZ that the proposed methods will not damage the equipment.
Working with electronic boards, plugs, and cables requires delicate handling. Proper electrostatic discharge (ESD) procedures
should befollowed during replacement of any electronic board. Failure to do so mayresult in damage to the board.
If device is set to operate in any Automatic mode, the device will shut down and activate the CHECK PROBE alarm if the patient
temperaturefalls below 30.0°C (86°F). Patient temperature must rise above 30.0°C (86°F) before restarting the device in
Automatic mode. The device can be operated in Manual Control modein order to warm the patient above 30.0°C (86°F). Potential
for interruption of therapy.
Unapproved blankets or hose should never be used.

OPERATION MANUAL BLANKETROL III, Model 233
Page 8 of 41
SECTION 1. INTRODUCTION
1-0. GENERAL SAFETY PRECAUTIONS
To provide the patient maximum safety during the use of the BLANKETROL III Hyper-Hypothermia System, a thorough
knowledge and understanding of the system, and its correct application and operating use are required. Each person who is
responsible for use or direction of use of the system, such as physicians, nurses, technicians and operators must read and
understand this operating manual and all precautions and warnings prior to use. It is recommended this manual be read at least
semi-annually as a refresher for safe operation and application. For proper knowledge and understanding, in-service is
available upon request.
1-1. GENERAL DESCRIPTION OF THE BLANKETROL III SYSTEM
INDICATIONS FOR USE
The BLANKETROL III Hyper-Hypothermia Temperature Management System is used to lower or to raise a patient’s
temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a
heater, a compressor, a circulating pump and blankets/pads.
BLANKETROL III Model 233
This unit requires no field adjustments or calibrations in order to maintain the precise board measurement of temperature and
temperature limits.
Distilled water is heated or cooled and pumped from the unit to a blanket. The blanket* rests under and/or on top of the patient
and is designed so that the water circulates through the blanket and returns to the unit.
If water that is at a lower temperature than the patient’s temperature is circulated through the blanket, the desired effect is to
reduce the patient's temperature. If water that is at a higher temperature than the patient’s temperature is circulated through the
blanket, the desired effect is to elevate the patient's temperature.
The BLANKETROL III unit can be set so that it operates based on the temperature of the water in the BLANKETROL III
equipment (MANUAL CONTROL MODE) or it can be set so that it operates based upon the patient’s temperature (Automatic
Modes). The five Automatic modes include:
1) AUTO CONTROL MODE
2) GRADIENT 10C MODE
3) GRADIENT 10C SMART MODE
4) GRADIENT VARIABLE MODE
5) GRADIENT VARIABLE SMART MODE
The BLANKETROL III System can also be used solely to monitor the temperature of the patient (MONITOR ONLY MODE).
The BLANKETROL III is intended for use in ambient temperatures of 15°C –30°C (59°F –86°F). The maximum contact surface
temperature is 41°C (105.8°F).
* The recommended blanket(s) for use are described in the Operation and Technical Manual
1-2. PHYSICAL DESCRIPTION OF THE BLANKETROL III UNIT
See Section (5) for specifications and certifications of the BLANKETROL III.

OPERATION MANUAL BLANKETROL III, Model 233
Page 9 of 41
1-2.1. External Features - Front View
The external features in Figure (1-1) of the BLANKETROL III unit are described as follows:
A. The control panel is composed of pressure sensitive touch switches, nine LED indicators, a liquid crystal display, and
two LED displays. An expanded description of the membrane control panel is presented in Section (1-2.4)
B. The recessed handle permits the operator to grip the unit when moving it.
C. The power switch is a bevel rocker switch labeled “I” (on) at the top and “O” (off) at the bottom. The switch illuminates
green when the unit is on. A circuit breaker is built into the switch to protect against overload conditions.
D. The storage drawer tilts out from the top to provide storage space for items such as probes, connecting cables,
connecting hoses, the drain hose, and the Operation Manual.
E. The grill permits air to be drawn into the unit and pass over the condenser. The air is then discharged through the
bottom of the unit. The grill and compressor should be kept clear from blockage and cleaned regularly as described in
the Operation and Technical Manual.
F. The protective bumper guard surrounds the lower edge of the unit and protects the unit as well as the walls.
G. Four swivel casters are specially designed to permit the unit to move easily and to prevent it from tipping. The unit is
equipped with two locking casters to prevent unintended movement during operation.
FIGURE 1-1. BLANKETROL III - FRONT VIEW

OPERATION MANUAL BLANKETROL III, Model 233
Page 10 of 41
1-2.2. External Features –Right Side View
The external features in Figure (1-2.) of the BLANKETROL III unit are described as follows:
A. The water flow indicator is a paddle wheel immersed in the path of the circulating water with a window to the outside.
As water is circulated through the system, it passes over the paddle wheel causing it to spin (like a pinwheel). The
water flow indicator provides a visual display of the general rate at which the water is circulating. For example, if the
unit is circulating water but the connecting hose is pinched, the circulation of the water is restricted. The restriction in
water flow decreases the speed of the paddle wheel. A total obstruction of the water path will cause the paddle wheel
to stop completely.
The water flow indicator only spins when a blanket or by-pass hose is connected to the unit. It will not spin while the
water is being circulated internally to pre-condition the water to the ‘preset” water temperature chosen by the
operator.
B. The air vents, on both the right and left side of the unit, provide air circulation for the microprocessor.
C. The four capped screws on the right and left side of the unit secure the top to the base.
D. The patient 1/4 inch receptacle is where the 400 Series probe is connected to the unit. Only one patient probe can be
connected at a time.
E. Three female, quick-disconnect return couplings on the top row are designed for water to flowin when the male
coupling of the connecting hose is attached.
F. The three male quick-disconnect outlet couplings on the bottom row are designed for water to flow out when the
female coupling of the connecting hose is attached.
G. The power cord with a hospital-grade plug should only be plugged into a properly grounded hospital grade
receptacle. Electrical Specifications are described in Section (5.).
H. The isolation label indicates that the BLANKETROL III and the blanket (applied part) are BF rated as a system.
Contact with other parts (i.e. the quick-disconnect couplings) at the same time as contacting the patient will negate
the type of BF rating.
FIGURE 1-2. BLANKETROL III - RIGHT SIDE VIEW

OPERATION MANUAL BLANKETROL III, Model 233
Page 11 of 41
1-2.3. External Features –Rear View
The external features in Figure (1-3.) of the BLANKETROL III unit are described as follows:
A. The specification label outlines the BLANKETROL III unit's electrical requirements and displays the serial and model
numbers of the unit.
B. The air vents, on both the right and left side of the unit, provide air circulation for the microprocessor.
C. The nylon strap is used to secure and store the coiled power cord when not in use.
D. The rear enclosure panel secured with four screws provides access to the interior. The panel is removed to perform
maintenance, repair, or replacement of components.
E. The water fill opening is where the operator pours distilled water into the unit to fill the reservoir.
F. The operating instructions are printed directly on the back lid of the unit. This allows the operator to clearly see the
directions and efficiently use the unit.
G. The USB port for data reporting functions.
FIGURE 1-3. BLANKETROL III - REAR VIEW

OPERATION MANUAL BLANKETROL III, Model 233
Page 12 of 41
1-2.4. Description of the BLANKETROL III Membrane Control Panel
The membrane control panel as shown in Figure (1-4.A.) for English and (1-4.B) for Symbols is composed of pressure sensitive touch
switches and LED displays. The membrane control panel is divided into the following sections:
A. The display labeled WATER shows the water temperature in the BLANKETROL III equipment.
B. The MANUAL CONTROL button is used to activate the MANUAL CONTROL MODE. This mode’s operation is
based on the water temperature within the BLANKETROL III equipment relative to the desired Set Point temperature.
C. The center display reports the status of the unit, displays the Set Point, and/or indicates changes the operator should
make. It is referred to as the Status Display. The possible Status Displays are listed in Section (3-12.).
D. The TEMP SET button and the Up and Down arrow buttons are used to adjust the Set Point as shown on the LCD
display.
E. The display labeled PATIENT shows the patient’s temperature reading.
F. The AUTO CONTROL button is used to activate the AUTO CONTROL MODE.
G. The GRADIENT 10C button is used to activate the GRADIENT 10C MODE.
H. The GRADIENT VARIABLE button is used to activate the unit GRADIENT VARIABLE MODE.
I. The SMART button is used to activate the SMART function in the appropriate modes.
J. The MONITOR ONLY button is used tomonitor the patient’s temperature without heating, cooling or circulating the
water.
K. The two switches labeled TEST INDICATORS and SILENCE ALARM are used to confirm that all the indicators on
the membrane control panel are working and to silence the alarm in certain conditions.
L. The POWER FAILURE symbol flashes the red LED to the left of the symbol and sounds an audible alarm when the
unit loses power or when power has been interrupted, restored, and the unit does not resume previous operation.
M. The LOW WATER symbol indicates the unit is low on water. The unit flashes the red LED to the left of the symbol,
sounds an audible alarm, and displays ”LOW WATER” in the Status Display. Refer to Section (3-12-D. Low Water).
N. The C/F Button allows the operator to select themeasurement scale, Celsius or Fahrenheit, by which the unit
functions. This feature is only available on 115 Volt BLANKETROL III Systems.
FIGURE 1-4.A. BLANKETROL III - MEMBRANE CONTROL PANEL (English)

OPERATION MANUAL BLANKETROL III, Model 233
Page 13 of 41
FIGURE 1-4.B. BLANKETROL III - MEMBRANE CONTROL PANEL (Symbols)
1-3. REQUIRED ACCESSORIES
Operation of the BLANKETROL IIISystem requires the use of the blanket(s) designed to circulate warm or cool distilled water, a
connecting hose with quick-disconnect male and female couplings and, if any of the automaticmodes are to be utilized, a 400
Series thermistor probe. Use only approved CSZ accessories including the Maxi-Therm®, Maxi-Therm Lite®, PlastiPad®, Gelli-
Roll®, and Kool Kit®product families and the Head Wrap. See the Operation and Technical Manual for additional details.
1-4. USB PORT OPERATION
Refer to CSZ manual 57059 for instructions and usage of the BLANKETROL III Data Export Software.
SECTION 2. GENERAL PREPARATION OF THE BLANKETROL III
SYSTEM
2-1. INTRODUCTION
This section describes the procedures to prepare the BLANKETROL III System for general use. This entails unpacking the
shipment, arranging all the equipment for the first time, and completing a test routine. This section also outlines standard safety
precautions and patient preparation/bedside care when using the hyper-hypothermia blanket(s). Technical support is available
upon request.
CAUTION
Do not make any connection tothe USB port terminal whilethe device is also connected to a patient. Do not touch this connector
and the patient at the same time. Patient injurymay result.
WARNING
The USB connection on the BLANKETROL III unit is intendedfor data transfer to a computer. Any other uses/connections
mayresult in damage to the BLANKETROL III unit.

OPERATION MANUAL BLANKETROL III, Model 233
Page 14 of 41
2-2. UNPACKING THE SHIPMENT
See the Operation and Technical Manual for details.
2-3. FIRST TIME SET-UP/SYSTEM TEST ROUTINE
See the Operation and Technical Manual for details.
2-3.1. Inspecting and Arranging the Equipment
A. Place the BLANKETROL III System in an uncluttered work space that is accessible to the correct power source with an
ambient temperature between 15°C –30°C (59°F –86°F). Position the unit so that themembrane control panel faces
the operator.
B. Visually inspect the BLANKETROL III System to determine that there are no missing parts, unusual dents,or punctures.
C. Examine the power cord for cuts or exposed wires and the power plug for bent or missing prongs.
D. Review Section (1-2) to identify the features of the BLANKETROL III System.
E. Collect and arrange the following equipment and supplies:
1. Hyper-hypothermia blanket(s)
2. Connecting hose with quick-disconnect fittings if using disposable blanket(s).
3. 400 Series Thermistor Probes / connecting cables described in the Operation and Technical Manual.
F. Lift the lid of the water fill opening and gradually pour approximately 2 gallons (7.6 liters) of distilled water into the
reservoir. Stop pouring when the water reaches the strainer visible at the bottom of the water fill opening.
!
G. The BLANKETROL III and the blanket (applied part) are BF rated as a system. Contact with other parts (i.e. the quick-
disconnect couplings) at the same time as contacting the patient will negate the type BF rating.
H. Connect the blanket(s) to the unit by attaching the quick-disconnect female coupling of the connecting hose to amale
outlet coupling (on the bottom row) of the unit. Attach the male quick-disconnect coupling of the connecting hose to a
female return coupling (on the top row) of the unit. Each blanket must be connected to one outlet and one return.
To attach the couplings:
1. Grasp the femalecoupling of the connecting hose
2. Slide the collar back towards the hose
3. Push the female coupling over a male coupling of the unit
4. Allow the collar to SNAP into place and return to its original position
5. Gently pull on the connecting hose to assure a positive connection
6. Next, push back the collar of a female return hose on the unit with one hand
7. Withthe other hand, insert the male coupling of the connecting hose
8. Release the collar of the female return coupling
9. Push the male coupling until it SNAPS into position
10. Gently pull the connecting hose to assure a positive connection
I. Check that the blanket is lying flat and that the connecting hose to theunit is not twisted or pinched.
J. Check that the power switch of the unit is in “O” position (unit is off).
K. Connect the plug to a properly grounded hospital grade receptacle.
2-3.2. Complete a System Test Routine
See the Operation and Technical Manual for details.

OPERATION MANUAL BLANKETROL III, Model 233
Page 15 of 41
2-4. UNIT AND PATIENT RELATED PRECAUTIONS
This unit requires both water and electricity to operate.
Please consult the Warnings and Cautions section for a complete list of warnings and cautions related to the BLANKETROL
III.
A. Anytime the unit sounds an alarm, the operator should immediately check the Status Display and act accordingly,
e.g., add water, remove from service, check the probe, etc.
B. The BLANKETROL III unit is equipped with a circuit breaker in the I/O (on/off) power switch to protect against current
overload.
2-5. PATIENT PREPARATION AND BEDSIDE CARE
Effective use of the BLANKETROL III System must include proper patient care prior to and while using the hyper-hypothermia
blanket(s).
A dry sheet should be placed between the hyper-hypothermia blanket and the patient when using PLASTIPAD®, or MAXI-
THERM®Blankets. The MAXI-THERM LITE®Blanket does not require an interposed sheet.
While using a hyper-hypothermia blanket include the following tasks:
A. A physician's order is required for setting blanket temperature and use of equipment. Atleast every 20 minutes, or as
directed byphysician, check patient's temperature and skin integrity of areas in contact with blanket; also, checkthe
BLANKETROL III’s water temperature. Pediatric patients, temperature-sensitive patients with vascular disease,
surgical patients, diabetics and patients with Raynaud’s Disease should be checked more frequently. Notify the
physician promptly of anychange in patient status in order to avoid serious injuryor death.
B. The position and the placement of the 400 Series probe should be inspected regularly. Also, the BLANKETROL III
System activates an alarm in the automatic modes when the patient probe registers outside the range of 30°C -
43.5°C (86°F - 110.3°F).
C. Changes in skin color, edema, inflammation, or indications of pressure, especially over bony prominences, should be
noted and treated promptly as ordered. Avoid prolonged tissue pressure and shearing forces over bony
prominences.
D. The patient should be turned and properly re-positioned according to hospital/institution policy/protocol.

OPERATION MANUAL BLANKETROL III, Model 233
Page 16 of 41
SECTION 3. OPERATING THE BLANKETROL III SYSTEM
3-1. INTRODUCTION
This section describes howto operate the BLANKETROL III System in order to control a patient's temperature. First, collect the equipment
and prepare the patient. Second, decide which mode of operation to use. Third, set the appropriate controls:
AUTOMATIC CONTROL MODE,
MANUAL CONTROL MODE,
GRADIENT 10C MODE,
GRADIENT 10C SMART MODE,
GRADIENT VARIABLE MODE,
GRADIENT VARIABLE SMART MODE
MONITOR ONLY MODE.
For proper knowledge and understanding of the unit, in-service is available upon request.
3-2. ARRANGING THE SYSTEM COMPONENTS
A. Collect all supplies and equipment
1. BLANKETROL III unit
2. Hyper-hypothermia blanket(s)
3. Dry sheet or bath blanket
4. Connecting hose (if blanket requires it)
5. 400 Series probe
6. Connecting cable (if using disposable probes)
7. Distilled water
B. Place the BLANKETROL III unit in the patient area, accessible to the correct power source, and in an ambient
environment of 15°C –30°C (59°F –86°F).
C. Review Section (1-2.) that outlines the features of the unit and membrane control panel.
D. Check the level of distilled water in the reservoir. To do so, lift the cover of the water fill opening and check if the
water is visibly touching the strainer. If needed, carefully add distilled water. In addition, if the water falls below a
preset level, the alarm sounds and the Status Display flashes LOW WATER. The operator cannot proceed until this
is corrected as described in Sections (3-12-D.) and (4-3.1).
E. Check that the power switch is in the “O” position (unit is off).
F. Inspect the power plug for bent or missing prongs.
WARNING
Due to electromagnetic compatibility, the BLANKETROL III unit should not be used adjacent to or stacked with other
equipment. Potential electromagnetic interference may result. Other equipment includes ventilators, patient monitors,
anesthesia delivery equipment, etc. Electromagnetic interference refers to electronic devices unintentionally affecting the
operation of each other by emitting electromagnetic energy. Unit complies with IEC 60601-1-2.
If the BLANKETROL III unit or the other equipment is not operating normally, remove the device from service and have a
biomedical or service technician observe the device in operation. Refer to Section 5 for recommended separation distances
between other equipment and the BLANKETROL III. Failure to do so may result in damage to the BLANKETROL III
system and patient injury.
CAUTION
Use distilled water only. Do NotUse De-Ionized water. De-Ionized water may cause corrosion to plumbing system
components. Do Not Use TapWater. Minerals and deposits can clog plumbing system components.
Do not use alcohol. Alcoholmay cause blanket deterioration.
Do not overfill. Overfilling may result in overflow when the water in the blanket drains back into the system when the system is
turned off.

OPERATION MANUAL BLANKETROL III, Model 233
Page 17 of 41
WARNING
Do not by-pass ground lug (230V System). Electrical hazards may result.
G. Insert the plug into a properly grounded hospital grade receptacle.
H. Lay the hyper-hypothermia blanket flat with the hose routed, without kinks, towards the unit.
I. If the blanket is already filled, check that there are no leaks.
WARNING
Any time water is found leaking into or around the unit, connecting hose, and/or blanket, turn the unit off, disconnect
the power cord from its power source, and correct the problem before proceeding. Proper maintenance procedures
should be followed including, but not limited to, the preventative maintenance described in this manual. Leaky blankets
or hoses should never be used. Water leaks could present a slip hazard and risk of infection and could lead to
electric shock.
J. Cover the blanket with a dry sheet or bath blanket (if using PLASTIPAD®, or MAXI-THERM®Blanket).
K. Connect the blanket to the BLANKETROL III unit as described in Section (2-3.1.) Step (H).
L. If a single-patient use hyper-hypothermia blanket is used, connect the color coded couplings of the connecting hose
to the blanket as described in the instructions packaged with each blanket.
M. Check that the blanket is flat and the connecting hose is not twisted or pinched.
N. The hyper-hypothermia blanket may be pre-cooled or pre-warmed before positioning the patient. To do so, operate
the system in MANUAL CONTROL MODE for a few minutes.
O. Place the patient on the hyper-hypothermia blanket.
P. If the patient's temperature is to be monitored as required in an automatic control mode or MONITOR ONLY MODE,
insert or attach one 400 Series probe in or on the patient.
1. A rectal probe is inserted into the rectum and secured with tape to the leg of the patient.
2. The diaphragm of a skin probe is taped to the patient, usually under the patient's arm or on the chest.
3. The esophageal probe is inserted in the patient. It is often preferred that the patient is comatose or under
anesthesia when the probe is placed in the esophagus.
The 400 Series probe should be inspected periodically to insure that it is not dislodged or impacted. The
BLANKETROL III System sounds an alarm when the reading from the probe falls below 30°C (86°F).
It is important that the 400 Series probe be inserted in or attached to the patient at least three
minutes before pressing a control mode button. This will prevent the accidental triggering of the
CHECK PROBE status message.
4. The probe connecting cable is used to connect the BLANKETROL III System to disposable temperature
probes.
Q. If an upper hyper-hypothermia blanket is to be used, follow instructions in step (J).
R. Connect the top blanket to the unit following the procedure described in Section (2-3.1.) Step (H).
S. If no top hyper-hypothermia blanket is used, cover the patient with a top sheet. Patient preparation and bedside care
are further described in Section (2-5.).
T. Choose which operating mode to use: Operating in AUTO CONTROL MODE is described in Section (3-3.).
Operating in MANUAL CONTROL MODE is described in Sections (3-4.) and (3-5.). Operating in GRADIENT 10C
MODE is described in section (3-6.). Operating in GRADIENT 10C SMART MODE is described in Section (3-7.).
Operating in GRADIENT VARIABLE MODE is described in Section (3-8.). Operating in GRADIENT VARIABLE
SMART MODE is described in Section (3-9.). Operating in MONITOR ONLY MODE is described in Section (3-10.).
NOTE: The maximum contact surface temperature is 41°C.
CAUTION
Handling or use of the patient probe may result in damage from electrostatic discharge (ESD) if proper precautions are not
taken.

OPERATION MANUAL BLANKETROL III, Model 233
Page 18 of 41
NOTE: If at any time, power is removed from the unit without actuating the power switch (I/O switch) a power fail alarm will
activate and the Power fail symbol LED located on the membrane control panel will flash. To stop the alarm, restore power or
push the SILENCE ALARM button.
In the case that the unit is powered-off for 5 seconds or less, the unit will resume the previous operation mode.
However, if power is off longer than 5 seconds, the unit will go into power fail alarm mode.
3-3. OPERATING THE BLANKETROL III SYSTEM IN AUTO CONTROL MODE
In AUTO CONTROL MODE, the BLANKETROL III System can monitor the patient’s temperature and deliver the maximum heating or
cooling therapy in order to bring the patient’s temperature to a Set Point chosen by the operator.
After arranging the equipment as described in Section (3-2.), proceed as follows:
A. Check the placement of the 400 Series probe in or on the patient.
B. Connect the 400 Series probe to the 1/4 inch receptacle on the right side of the unit. If using a disposable probe, a
connecting cable is needed to connect the probe to the BLANKETROL III.
C. Press the power switch to the “I” position.
1. The switch illuminates green.
2. The microprocessor board goes through self-test.
3. The Status Display flashes CHECK SETPT.
D. Consult the physician's orders to determine the desired patient Set Point temperature. As a safety precaution, the
SET POINT display can only be set between 30°C - 40°C (86°F - 104°F) to operate in AUTOMATIC CONTROL
MODE.
E. Use the C/F button to choose the desired temperature scale (English membrane only).
F. Press the TEMP SET button.
1. The microprocessor board beeps.
2. The LED in the corner of the button illuminates.
3. The SET POINT display shows a temperature reading.
4. The Status Display shows SET TEMP.
WARNING
A physician's order is required for setting blanket temperature and use of equipment. Atleast every 20 minutes, or as directed by
physician, check patient's temperature and skin integrity of areas in contact with blanket; also, check the BLANKETROL III’s
water temperature. Pediatric patients, temperature-sensitive patients with vascular disease, surgical patients, diabetics and
patients with Raynaud’s Disease should be checked more frequently. Notify the physician promptly of any change in
patient status in order to avoid serious injuryor death.
Due to static electricity, a 400 Series Probe may not be connected to the BLANKETROL III unit without first discharging
one’s body to the frame of the BLANKETROL III unit or another grounded object. Failure to do so may result in damage
from electrostatic discharge (ESD). All staff that may touch the 400 Series Probe must be familiar with this warning and basic
static electricity orelectrostatic discharge (ESD)training.
Basic static electricity or ESD training should include an introduction to the physics of electrostaticcharge, the voltage levels that
can occur in normal practice and the damage that can be doneto electronic components if equipment is touched by an operator
who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge,
and how and why to discharge one’s body to the BLANKETROL III unit or another grounded object. Failure to do so may
result in damage from electrostatic discharge (ESD).
CAUTION
If device is set to operate in any Automatic mode, the device will shut down and activate the CHECK PROBE alarm if the patient
temperaturefalls below 30.0°C (86°F). Patient temperature must rise above 30.0°C (86°F) before restarting the device in
Automatic mode. The device can be operated in Manual Control modein order to warm the patient above 30.0°C (86°F).
Potential for interruption of therapy.

OPERATION MANUAL BLANKETROL III, Model 233
Page 19 of 41
G. Press the Up arrow or Down arrow to change the SET POINT display to the desired patient temperature. The display
can only be set between 30°C -40°C (86°F - 104°F) or else the system will not operate in AUTOMATIC CONTROL
MODE.
1. The microprocessor board beeps.
2. The Set Point on the Status Display changes.
H. Press the AUTO CONTROL button.
1. The microprocessor board beeps.
2. The LED in the corner of the button illuminates.
3. The Patient display shows the patient's actual temperature.
4. The WATER display shows the actual temperature of the water in the BLANKETROL III equipment.
5. The Status Display indicates:
* XXXXXX PATIENT
AUTO SETPT 37.0 C
Or Status Display shows:
PATIENT @SETPT
AUTO SETPT 37.0 C
* (”XXXXXX” represents “HEATING” or “COOLING”.)
The above depends upon the relationship of the patient temperature to the Set Point temperature. Note
that the Set Point may be displayed in Fahrenheit.
6. The pump is activated. The heater or compressor may also be activated.
7. The water flow indicator on the right side panel begins to move.
8. The water moves from the unit to the blanket and returns to the unit.
I. Check the water flow indicator to confirm that the water is circulating.
J. Touch the hyper-hypothermia blanket to confirm that the blanket is heating/cooling.
K. To make any changes in the control settings, press the TEMP SET button and begin again.
The BLANKETROL III System is now operating in AUTOMATIC CONTROL MODE. You should continue to monitor the system and the
patient. (Reviewthe suggestions for patient care described in Section (2-5.)).
If at any time the Status Display shows a message other than the messages described in AUTOMATIC CONTROL MODE procedures,
make the changes indicated by the display and/or consult the list of display messages in Section (3-12.). If at any time the unit sounds an
alarm and the Status Display flashes a message, make the changes indicated. To turn off the unit or discontinue hyper-hypothermia
treatment, proceed as described in Section (3-11.).
NOTE: IN ORDER TO CHANGE FROM ANY CONTROL MODE TO ANOTHER CONTROL MODE, FIRST PRESS
THE “TEMP SET” BUTTON, AND THEN SELECT THE OPERATING MODE OF CHOICE.
In order to change from AUTOMATIC CONTROL MODE to MONITOR ONLY MODE, press the MONITOR ONLY button.
3-4. OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE
The BLANKETROL III System can be set sothat it operates based upon the actual temperature of the water in the BLANKETROL III
equipment relative to the Set Point temperature.
WARNING
A physician's order is required for setting blanket temperature and use of equipment. Atleast every 20 minutes, or as directed by
physician, check patient's temperature and skin integrity of areas in contact with blanket; also,check the BLANKETROL III’s
water temperature. Pediatric patients, temperature-sensitive patients with vascular disease, surgical patients, diabetics and
patients with Raynaud’s Disease should be checked more frequently. Notify the physician promptly of any change in
patient status in order to avoid serious injuryor death.