CSZ Blanketrol III 233 User manual

Operation and Technical Manual
Model 233 Hyper-Hypothermia System
Cincinnati Sub-Zero Products, LLC 12011 Mosteller Road Cincinnati, Ohio 45241, U.S.A.
www.cszmedical.com

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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BLANKETROL®is a registered trademark of Cincinnati Sub Zero Products, LLC, Cincinnati, Ohio
USA.
©Copyright 2017, Cincinnati Sub-Zero Products, LLC All rights reserved.
Manual 57299 Rev. D
ECN: M1708-5362

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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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
Automatic
Control
Manual
Control
Test Indicators
10C
Gradient 10˚ C
V
Gradient
Variable
5C
Smart
Mode
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
~
USB Port: Insert Port
in This Direction
Monitor
Only
INCREMENT
(Increase
Temperature)
DECREMENT
(Decrease
Temperature)
Equipotential
Symbol
OFF/ON
OFF / ON Switch

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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BLANKETROL®III
OPERATION AND TECHNICAL 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 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 injury or death.
The method of temperature control 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 maintain contact between the patient and the blanket during therapy may be required and
should not block the fluid pathways of the blanket or connecting hose. Failure to do so may result
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.
Proper sanitation 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 (refer to Table (6-8)). Failure to
do this will cause incorrect temperature readings and may result 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 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
or electrostatic discharge (ESD) training.
Basic static electricity or ESD training should include an introduction to the physics of electrostatic
charge, the voltage levels that can occur in normal practice and the damage that can be done to
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).

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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WARNING
Do not use the BLANKETROL III system in the presence of flammable anesthetics. Risk of
explosion can result.
Remove the BLANKETROL III from service if the outer casing or membrane 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 therapy and excessive surface temperatures 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 be followed during replacement of any electronic board.
Failure to do so may result in damage to the board.
If unit requires repair, do not attempt to fix unit on your own. Only qualified personnel should perform
repairs. Damage to the unit or malfunction may otherwise result.
Use of accessories other than those specified in Table 6-8 may result in increased
electromagnetic emissions or decreased immunity to 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.
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
therapy could result in serious injury or death.
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.
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 7 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.
Always unplug the unit before accessing internal components during service. Failure to unplug
the unit could result in electric shock.

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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WARNING
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 servicing medical 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 may result 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/SYSTEM TEST ROUTINE in Section 2 must always be performed. Improper repair and
inadequate maintenance can result in damage to the BLANKETROL III system and patient
injury.

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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CAUTION
U.S. Federal law restricts this device to sale by or on the order of a physician.
Use distilled water only. Do Not Use De-Ionized water. De-Ionized water may cause corrosion
to plumbing system components. Do Not Use Tap Water. Minerals and deposits can clog
plumbing system components.
Do not use alcohol. Alcohol may 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 BLANKETROL III 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 so may result in damage to the
probes.
If the unit was shipped on its side, permit the unit to 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 to the USB port terminal while the device is also connected to a patient.
Do not touch this connector and the patient at the same time. Patient injury may 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 be followed during replacement of any electronic board.
Failure to do so may result 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 temperature falls 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 mode in order to warm the patient above 30.0°C (86°F). Potential for interruption of
therapy.
Unapproved blankets or hoses should never be used.

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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Table of Contents
TECHNICAL HELP TELEPHONE [phone] .........................................................................................11
BEFORE YOU CALL FOR SERVICE....................................................................................................................11
IN-WARRANTY REPAIR AND PARTS ...............................................................................................................11
RECEIVING INSPECTION .....................................................................................................................................11
IMPORTANT SAFETY INFORMATION .............................................................................................................. 11
SECTION 1. INTRODUCTION............................................................................................................................... 12
1-0. GENERAL SAFETY PRECAUTIONS..................................................................................................... 12
1-1. GENERAL DESCRIPTION OF THIS MANUAL .................................................................................... 12
1-2. GENERAL DESCRIPTION OF THE BLANKETROL III SYSTEM....................................................... 12
1-3. PHYSICAL DESCRIPTION OF THE BLANKETROL III UNIT ............................................................ 14
1-3.1. External Features - Front View ............................................................................................................ 14
1-3.2. External Features –Right Side View .................................................................................................... 16
1-3.3. External Features –Rear View.............................................................................................................18
1-3.4. Description of the BLANKETROL III Membrane Control Panel ......................................................... 20
1-4. REQUIRED ACCESSORIES.................................................................................................................... 21
1-5. FUNCTIONAL DESCRIPTION OF THE BLANKETROL III SYSTEM ................................................ 21
1-5.1. Theory of Operation.............................................................................................................................. 21
1-5.2. Heating System ..................................................................................................................................... 23
1-5.3. Cooling System ..................................................................................................................................... 23
1-5.5. Temperature Safety Control System...................................................................................................... 24
1-5.6. USB Port Operation.............................................................................................................................. 25
SECTION 2. GENERAL PREPARATION OF THE BLANKETROL III SYSTEM.........................................26
2-1. INTRODUCTION.....................................................................................................................................26
2-2. UNPACKING THE SHIPMENT............................................................................................................... 26
2-3. FIRST TIME SET-UP/SYSTEM TEST ROUTINE ..................................................................................26
2-3.1. Inspecting and Arranging the Equipment ............................................................................................. 26
2-3.2. Completing a System Test Routine........................................................................................................ 28
2-4. UNIT AND PATIENT RELATED PRECAUTIONS................................................................................ 35
2-5. PATIENT PREPARATION AND BEDSIDE CARE................................................................................ 36
SECTION 3. OPERATING THE BLANKETROL III SYSTEM......................................................................... 40
3-1. INTRODUCTION.....................................................................................................................................40
3-2. ARRANGING THE SYSTEM COMPONENTS....................................................................................... 40
3-3. OPERATING THE BLANKETROL III SYSTEM IN AUTO CONTROL MODE ....................................43
3-4. OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE............................... 46
3-5. OPERATING THE BLANKETROL III SYSTEM IN MANUAL CONTROL MODE WITH THE
ADDITION OF THE PATIENT PROBE................................................................................................................. 48
3-6. OPERATING THE BLANKETROL III SYSTEM IN GRADIENT 10C MODE....................................... 49
3-7. OPERATING THE BLANKETROL III UNIT IN GRADIENT 10C SMART MODE................................ 52
3-8. OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE MODE............................ 54
3-9. OPERATING THE BLANKETROL III SYSTEM IN GRADIENT VARIABLE SMART MODE .............. 57
3-10. OPERATING THE BLANKETROL III SYSTEM IN MONITOR ONLY MODE ..................................... 60
3-11. CONCLUDING HYPER-HYPOTHERMIA TREATMENT.................................................................... 61
3-12. STATUS DISPLAY MESSAGES............................................................................................................. 62
SECTION 4. GENERAL MAINTENANCE OF THE BLANKETROL III SYSTEM ....................................... 69
4-1. INTRODUCTION.....................................................................................................................................69
4-1.1. TEST EQUIPMENT REQUIRED ......................................................................................................... 70

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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4-2. MAINTENANCE OF THE WATER RESERVOIR..................................................................................72
4-2.1. Draining the Reservoir ......................................................................................................................... 75
4-2.2. Replenishing the Reservoir ...................................................................................................................76
4-3. MAINTENANCE OF THE WATER FILTER .......................................................................................... 76
4-4. MAINTENANCE OF THE CONDENSER AND GRILL......................................................................... 77
4-5. MAINTENANCE OF THE BLANKETROL III EXTERIOR –CLEANING INSTRUCTIONS..............78
4-6. MAINTENANCE OF THE HYPER-HYPOTHERMIA BLANKETS...................................................... 78
4.6.1 Reusable Blanket................................................................................................................................... 78
4-6.2. Disposable, Single-Patient Use Blankets.............................................................................................. 78
4-7. MAINTENANCE OF REUSABLE THERMISTOR PROBES................................................................. 79
4-8. LOW LIMIT SAFETIES CHECK............................................................................................................. 79
4-9. HIGH LIMIT SAFETIES CHECK ............................................................................................................ 80
4-10. TEMPERATURE ACCURACY CHECK................................................................................................. 81
4-11.DISPOSAL OF THE BLANKETROL UNIT............................................................................................ 82
SECTION 5. FIELD REPAIR/SERVICE OF THE BLANKETROL III UNIT..................................................83
5-1. INTRODUCTION.....................................................................................................................................83
5-2. ACCESS TO THE INTERIOR OF THE BLANKETROL III UNIT.......................................................... 86
5-2.1. Removing the Rear Enclosure Panel..................................................................................................... 86
5-2.2. Removing the Top of the Unit ...............................................................................................................86
5-2.3. Removing the Left Side Enclosure Panel .............................................................................................. 87
5-2.4. Disconnecting the Cables from the Microprocessor Board.................................................................. 87
5-2.5. Extending the Front Storage Drawer....................................................................................................88
5-2.6. Repositioning the Front Storage Drawer.............................................................................................. 88
5-3. REPLACEMENT OF THE HEATER .......................................................................................................89
5-4. REPLACEMENT OF THE WATER FILTER ASSEMBLY.....................................................................89
5-5. REPLACEMENT OF THE PUMP HOUSING.......................................................................................... 90
5-6. REPLACEMENT OF THE PUMP MOTOR............................................................................................. 91
5-7. REPLACEMENT OF THE FLOW SWITCH............................................................................................ 93
5-8. REPLACEMENT OF THE WATER TEMPERATURE SENSOR........................................................... 94
5-9. REPLACEMENT OF THE UPPER AND/OR LOWER WATER MANIFOLDS.....................................95
5-10. REPLACEMENT OF THE COMPRESSOR STARTING CAPACITOR, THE OVERLOAD
PROTECTOR, AND/OR THE COMPRESSOR RELAY........................................................................................ 96
5-11. REPLACEMENT OF THE THERMAL DISC OVER TEMPERATURE DEVICE ................................. 97
5-12. REPLACEMENT OR CLEANING OF THE WATER FLOW INDICATOR ASSEMBLY..................... 97
5-13. REPLACEMENT OF THE I/O POWER SWITCH................................................................................... 99
5-14. REPLACEMENT OF THE WATER LEVEL SENSOR ASSEMBLY...................................................... 99
5-15. REPLACEMENT OF THE MICROPROCESSOR BOARD AND/OR THE MEMBRANE CONTROL
PANEL…. ............................................................................................................................................................. 100
5-16. REPLACEMENT OF THE BEEPER ASSEMBLY ................................................................................ 101
5-17. REPLACEMENT OF THE POWER CORD ........................................................................................... 102
5-18. LEAKAGE CURRENT........................................................................................................................... 102
5-18.1. Arranging the Equipment............................................................................................................. 102
5-18.2. Taking Measurements in Normal Polarity ................................................................................... 102
5-18.3. Taking Measurements in Reverse Polarity................................................................................... 103
5-19. REFRIGERANT CHECK ....................................................................................................................... 103
5-20. TROUBLESHOOTING GUIDE ............................................................................................................. 104
SECTION 6. PARTS INFORMATION................................................................................................................. 113
6-1. INTRODUCTION...................................................................................................................................113
6-2. ORDERING INFORMATION FOR REPLACEMENT PARTS............................................................. 113
6-3. RECOMMENDED REPLACEMENT PARTS INVENTORY ............................................................... 113
6-4. RETURNING PARTS UNDER WARRANTY....................................................................................... 114
6-5. SHIPPING PARTS.................................................................................................................................. 114
SECTION 7. SPECIFICATIONS AND CERTIFICATIONS OF THE BLANKETROL III...........................124
WORLDWIDE ORDER PLACEMENT................................................................................................................ 128

OPERATION AND TECHNICAL MANUAL BLANKETROL III, Model 233
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FIGURES AND TABLES
FIGURE 1-1. BLANKETROL III - FRONT VIEW.............................................................................................................15
FIGURE 1-2. BLANKETROL III - RIGHT SIDE...............................................................................................................17
FIGURE 1-3. BLANKETROL III - REAR VIEW...............................................................................................................19
FIGURE 1-4.A. BLANKETROL III - MEMBRANE CONTROL PANEL (ENGLISH)....................................................21
FIGURE 4-1. BLANKETROL III MAINTENANCE CHECKLIST ...................................................................................71
FIGURE 5-1. BLANKETROL III - EXPOSED REAR VIEW ............................................................................................85
FIGURE 6-1. PARTS LIST A............................................................................................................................................115
FIGURE 6-2. BLANKETROL III - INTERNAL EXPLODED - FRONT VIEW..............................................................116
FIGURE 6-3. PARTS LIST B ............................................................................................................................................117
FIGURE 6-4. BLANKETROL III - INTERNAL EXPLODED - REAR VIEW................................................................118
FIGURE 6-5. BLANKETROL III - ELECTRICAL WIRING DIAGRAM.......................................................................119
FIGURE 6-6. BLANKETROL III - WATER CIRCULATION DIAGRAM.....................................................................120
FIGURE 6-7. BLANKETROL III - REFRIGERATION FLOW DIAGRAM ...................................................................121
TABLE 6-8. BLANKETROL III SYSTEM ACCESSORIES............................................................................................122
TABLE 7-1. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS.......126
TABLE 7-2. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY.......126
TABLE 7-3. GUIDANCE AND MANUFACTUERER'S DECLARATION - ELECTROMAGNETIC IMMUNITY.....127
TABLE 7-4. RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE BLANKETROL III, MODEL 233................................128