CSZ Norm-O-Temp 111W User manual

Operation / Technical Manual
Model 111W Hyperthermia System
Cincinnati Sub-Zero Products, LLC. 12011 Mosteller Road Cincinnati, Ohio 45241, U.S.A.
www.cszmedical.com

Operation/Technical Manual NORM-O-TEMP®, Model 111W
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NORM-O-TEMP®, MAXI-THERM®, MAXI-THERM®LITE, Gelli-Roll®and PLASTI-PAD® are registered
trademarks of Cincinnati Sub-Zero Products, LLC, Cincinnati, Ohio USA.
Copyright 2018 Cincinnati Sub-Zero Products, LLC. All rights reserved.
Manual 56430 Rev. AA
ECN M1801-5437

Operation/Technical Manual NORM-O-TEMP®, Model 111W
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SYMBOLS
Type BF
Equipment
I / O On / Off
~AC Voltage
Temperature Set
Water Temperature
Risk of Explosion:
Do not use in the
Presence of
Flammable
Anesthetics
Power Cord Holder
Danger; Risk of
Electric Shock
Increasing
Temperature
Decreasing
Temperature
Disconnect Power
Before Servicing
Water Flow Indicator
Outlet
Inlet
Silence Alarm
Caution: Read
Operation
Instructions and
Manual Before
Operating
Temp. Set Point
Indicator
Fill to Strainer
Fuse
Heat
Separate
collection for
electrical and
electronic
equipment
Protective Earth
(Ground)
Equipotentiality
Earth
(Ground)
Clean Water
Filter Quarterly
Caution
Low Water
Level
High Limit /
Over-Temperature
Safety Limit
Change Water
Monthly

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Cincinnati Sub-Zero Products, LLC, reserves the right to make changes to the device, which may not
be reflected in this manual.
WARNING
A physician's order is required for the use of the device and setting the temperature of the
blanket/pad. At least every 20 minutes, or as directed by physician, check patient's
temperature and skin condition of areas in contact with blanket/pad; also, check
blanket/pad water temperature. Pediatric patients, temperature-sensitive patients with
vascular disease, surgical patients, diabetic and Reynaud’s disease patients should be
checked more frequently. If patient’s temperature does not reach desired set point or
differs drastically from recommended set point, notify physician. Notify the physician
promptly of any change in patient status in order to avoid serious injury or death.
1. Pediatrics –Infant’s and children’s body temperatures are often more
responsive to surface heating and cooling than adults. Due to their size, the
effect of heating or cooling a child is likely more pronounced because of their
higher ratio of skin contact area to body mass.
2. Temperature Sensitive Patients –Patients with impaired peripheral blood
circulation and patients who are incapacitated may be more sensitive to
temperature changes than patients with normal circulation.
3. Surgical Patients –Patients with poor circulation due to inadequate heart
function, loss of blood, or impaired peripheral blood circulation may be more
sensitive to temperature changes.
The method of temperature control provided by all hyperthermia units presents the danger
of heating body tissues, particularly the skin, to a point where they are injured. Depending on
the extent and severity of a burn, very serious and even fatal complications may arise. Avoid
placing additional heating or cooling sources between the patient and blanket/pad.
Depending on the extent and severity of a burn, very serious and even fatal complications
may arise.
Do not use the NORM-O-TEMP®System distal to arterial cross clamping. Thermal injury
may result.
Prevent excessive and/or prolonged tissue pressure and shearing forces, especially over
bony prominences, to prevent skin damage that may result.
Do not place additional heat sources between the patient and blanket/pad. Skin damage
may result.
The area between the patient and the blanket/pad should be kept dry to avoid injury
to patient. Prep solutions have been reported to injure the skin when allowed to remain
between patients and a water-circulating heating blanket/pad during prolonged procedures.
If using a vinyl blanket/pad, place a dry absorbent sheet between the patient and the
blanket/pad to prevent moisture from accumulating.
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.
Do not use the NORM-O-TEMP®system in the presence of flammable anesthetics. Risk of
explosion can result.
Power interruption will cause the NORM-O-TEMP®to revert to Preset Set point Temperature
resulting in possible inaccurate therapy to the patient. Follow instructions for First Time Set-
Up/System Test Routine to resume operation. Failure to resume therapy could result in
serious injury or death.

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Do not by-pass ground lug. Electrical Hazards may result.
Any time water is found leaking into or around the unit, connecting hose, and/or
blanket/pad, turn the unit off, disconnect the power cord from its power source, and
correct the problem before proceeding. Water leaks could lead to electric shock. Water
leaks could also present a slip hazard.
Water leaks present a risk of infection and should be handled accordingly. Proper
sanitation procedures should be followed including, but not limited to, the preventative
maintenance described in this manual. Leaky blanket/pad(s) or hoses should never be
used.
Exercise extreme caution if the unit is used for patients who are electrically
susceptible (probe, catheter, or electrodes connected to the heart).
Do not position unit near any objects that can generate a strong electrical/magnetic field.
Potential electromagnetic interference may result.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
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 NORM-O-TEMP®should be performed by
qualified Medical Equipment Service Technicians, Certified Biomedical Engineering
Technicians, or Certified Clinical Engineers familiar with good repair practices for servicing
medical devices, and in accordance with instructions contained in the Operation / Technical
Manual. Improper repair could result in damage to the NORM-O-TEMP®system and
possible patient injury.
Before returning the NORM-O-TEMP®to patient use after repairs, the FIRST TIME SET-
UP/SYSTEM TEST ROUTINE in Section (3-2.) must always be performed. Improper repair
and inadequate maintenance can result in damage to the NORM-O-TEMP®system and
patient injury.
Remove the NORM-O-TEMP®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 the vents clean and free of debris and obstruction. Blockage of the vents could result
in the unit overheating which could render the unit unable to provide adequate
therapy; excessive surface temperatures could cause injury of patient or operator.
Keep unit, specifically the vents away from curtains or other obstructions.
The warming of transdermal medications (patches) can increase drug delivery,
resulting in possible injury to the patient.
Thermal injury may occur if heating/cooling therapy is applied to ischemic limbs.
Use only hospital grade plug or electric shock may result.

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CAUTION
Federal law (U.S.) restricts this device to sale by or on the order of a licensed healthcare
practitioner.
Use distilled water only. Do Not Use De-Ionized water.
Do not use alcohol. Alcohol may cause blanket/pad and unit deterioration.
Do not overfill. Overfilling may result in overflow when the water in the blanket/pad drains
back into the system when the system is turned off.
Always drain the NORM-O-TEMP®to a sanitary drain because bacteria may be present in the
unit’s water supply.
Working with electronic boards, plugs, and cables requires careful handling. Proper
Electrostatic Discharge (ESD) handling practices should be followed during
replacement of any electronic board.
To Discharge the NORM-O-TEMP®, ensure the unit is unplugged and use any metal tool, such
as a screwdriver, with an insulated handle to simultaneously touch both pins on the power
cord.
The operator must regularly monitor the patient whenever hyperthermia or normothermia
therapy is used.
For safe handling and use of chemicals follow manufacturer guidelines.
The device is still energized when the power switch is in the off position. To completely
disconnect the device from the power source, remove the power cord plug from the power
source.
Unapproved blanket/pad(s) or hoses should never be used. Always use CSZ
recommended blankets/pads.
No modification of this equipment is allowed without prior, written authorization from
CSZ.

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TABLE OF CONTENTS
Technical Help ..........................................................................................................................................................10
Before you call for Service.......................................................................................................................................10
In-Warranty Repair and Parts................................................................................................................................10
Receiving Inspection ................................................................................................................................................10
Important Safety Information................................................................................................................................10
NORM-O-TEMP®Operating Instructions Quick Start Guide...........................................................................11
Section 1. Introduction.................................................................................................................................13
1-0. General Safety Precautions............................................................................................................................13
1-1. General Description of this Manual............................................................................................................13
1-2. Description of the NORM-O-TEMP® Hyperthermia System.............................................................13
1-3. Physical Description of the Norm-O-Temp System.............................................................................14
1-3.1. External Features and Descriptions –Front View..........................................................................14
1-3.2. External Features and Descriptions –Left Side View....................................................................16
1-3.3. External Features and Descriptions –Rear View............................................................................18
1-3.4. External Features and Descriptions –Right Side View.................................................................20
1-3.5. External Features and Descriptions –Top View .............................................................................22
1-4. Required Accessories.......................................................................................................................................24
1-5. Functional Description of the NORM-O-TEMP System......................................................................24
1-5.1. Heating System..............................................................................................................................................24
1-5.2. Circulating System .......................................................................................................................................24
1-5.3. Temperature Safety Control System.....................................................................................................25
Section 2. Specifications and Certifications..........................................................................................26
Section 3. General Preparation of the NORM-O-TEMP®System ....................................................28
3-0. Introduction.........................................................................................................................................................28
3-1. Unpacking the Shipment ................................................................................................................................28
3-2. First Time Set-Up / System Test Routine................................................................................................28
3-2.1. Inspecting and Arranging the Equipment ..........................................................................................28
3-2.2. Completing a System Test Routine........................................................................................................30
3-3. Unit and Patient Related Precautions............................................................................................................32
3-4. Patient Preparation and Bedside Care......................................................................................................32
3-5. Alarms and Error Displays ............................................................................................................................33
Section 4. Operating the NORM-O-TEMP®System..............................................................................35
4-0. Introduction.........................................................................................................................................................35
4-1. Arranging the System Components ...........................................................................................................35
4-2. Operating the NORM-O-TEMP®System....................................................................................................36
4-3. Concluding the Use of the NORM-O-TEMP®System............................................................................37
Section 5. General Maintenance of the NORM-O-TEMP® System ...................................................38
5-0. Introduction.........................................................................................................................................................38
5-1. Maintenance of Water Reservoir ................................................................................................................40
5-1.1. Internal Clean using Bleach / Dry Storage Procedure ..................................................................40
5-1.2. Internal Cleaning and Disinfecton Using Gigasept FF / Dry Storage Procedure................42
5-1.3. Internal Cleaning and Disinfection Using Maranon H / Dry Storage Procedure................43
5-1.4. Draining the Reservoir ...............................................................................................................................44
5-1.5. Replenishing the Reservoir / Fixing a Low Water Alarm ............................................................45
5-2. Maintenance of the Water Filter .................................................................................................................45
5-3. Maintenance of the NORM-O-TEMP®Exterior –Cleaning Instructions .....................................47
5-4. Maintenance of the Hyper-Hypothermia Blanket / Pad(s)..............................................................47
5-4.1. Cleaning / Maintenance of Reusable Blanket / Pad(s) .................................................................47
5-4.2. Cleaning / Maintenance of Disposable, Single-Patient Use Blanket / Pad(s)......................47
Section 6. Field Repair / Service of the NORM-O-TEMP®.................................................................48
6-0. Introduction.........................................................................................................................................................48

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6-1. Access to the Interior.......................................................................................................................................49
6-1.1. Removing the Top of the Unit..................................................................................................................49
6-1.2. Replace / Reinstall the Top of the Unit................................................................................................50
6-1.3. Removing the Three-Sided Enclosure Panel.....................................................................................50
6-1.4. Replace / Reinstall the Three-Sided Enclosure Panel...................................................................50
6-2. Replacement of the Heater ............................................................................................................................50
6-3. Replacement of the Pump Housing............................................................................................................51
6-4. Replacement of the Pump Motor ................................................................................................................52
6-5. Replacement of the Water Filter Assembly. ...........................................................................................53
6-6. Replacement of the Water Temperature Sensor..................................................................................53
6-7. Replacement of the Water Manifolds........................................................................................................54
6-7.1. Outlet Manifold..............................................................................................................................................54
6-7.2. Return Manifold ............................................................................................................................................55
6-8. Replacement of the Independent High Limit Safety Thermostat ..................................................56
6-9. Calibration of the Independent High Limit Safety Thermostat......................................................57
6-10. Power Interrupt Test .......................................................................................................................................57
6-11. Hi-Limit Test........................................................................................................................................................57
6-12. Replacement or Cleaning of the Water Flow Indicator Assembly.................................................58
6-13. Replacement of the Power Switch..............................................................................................................59
6-14. Replacement of the Water Level Sensor Assembly.............................................................................59
6-15. Replacement of the Power Supply Board................................................................................................60
6-16. Replacement of the Microprocessor Board and/or the Control Panel........................................60
6-17. Electrical Safety..................................................................................................................................................61
6-17.1. Ground Integrity.......................................................................................................................................62
6-17.2. Leakage Current .......................................................................................................................................62
Section 7. Troubleshooting Guide ............................................................................................................63
Section 8. Parts Information ......................................................................................................................68
8-0. Introduction.........................................................................................................................................................68
8-1. Ordering Information for Replacement Parts .......................................................................................68
8-2. Recommended Replacement Parts Inventory.......................................................................................69
8-3. Returning Parts Under Warranty ...............................................................................................................69
8-4. Shipping Parts.....................................................................................................................................................69

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TABLE OF FIGURES
Figure 1. NORM-O-TEMP®unit, Front View .................................................................................................... 15
Figure 2. NORM-O-TEMP® unit, Left Side View.............................................................................................. 17
Figure 3. NORM-O-TEMP® unit, Rear View ...................................................................................................... 19
Figure 4. NORM-O-TEMP® unit, Right Side View........................................................................................... 21
Figure 5. NORM-O-TEMP®unit, Model 111W Top View. ........................................................................... 23
Figure 6. NORM-O-TEMP®, Model 111W Features....................................................................................... 27
Figure 7. NORM-O-TEMP®Maintenance Checklist....................................................................................... 39
Figure 8. NORM-O-TEMP®Internal Exploded –Front View.................................................................... 70
Figure 9. Front View Parts List............................................................................................................................... 71
Figure 10. NORM-O-TEMP®Internal Exploded –Rear View................................................................... 72
Figure 11. Rear View Parts List.............................................................................................................................. 73
Figure 12. NORM-O-TEMP®Internal Exploded Reservoir Assembly.................................................. 74
Figure 13. Reservoir Assembly Parts List ......................................................................................................... 75
Figure 14. NORM-O-TEMP®Electrical Wiring Diagram............................................................................. 76
Figure 15. NORM-O-TEMP®Water Circulation Diagram........................................................................... 77
Figure 16. NORM-O-TEMP®System Accessories ......................................................................................... 78

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Technical Help
United States and Canada Telephone [phone]
Cincinnati Sub-Zero Products, LLC Toll Free 1-800-989-7373
12011 Mosteller Road Fax [phone]
Cincinnati, OH 45241 (U.S.) 24hr Clinical Support 1-513-460-2038
E-Mail [email protected]
Visit our Web Site at http://www.cszmedical.com
Before you call for Service...
To help us better serve you, please have the serial number of your NORM-O-TEMP®unit
ready when you call for parts or service. The serial number is located on the specification
label on the back of the unit.
In-Warranty Repair and Parts
All parts on your NORM-O-TEMP®unit are covered by a one-year (1) warranty. Additional
warranties are available at the time of purchase or during the warranty period. To return
defective parts or units, first obtain a Returned Materials Authorization (RMA) number from
our Medical Technical Service department.
Receiving Inspection
After unpacking the NORM-O-TEMP®System, be sure to inspect the system for concealed
damage. Retain all packing material and carefully describe or photograph any damage.
Notify the carrier at once and ask for an inspection (in writing). Failure to do this within 15
days may result in loss of claim. Do not return the equipment to Cincinnati Sub-Zero. Call
our Medical Technical Service department for further instructions.
Important Safety Information
Refer to this manual for instructions and caregiver information. Read and understand all
precautionary information before using, prescribing, or servicing the NORM-O-TEMP®unit.

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NORM-O-TEMP®Operating Instructions Quick Start Guide
Read Operation Manual before using this device
First Time Use Cleaning:
Refer to section 5-1.1, 5-1.2 and 5-1.3 for cleaning instructions.
Initial Operation:
1. Check reservoir water level and fill if necessary
2. Insert power cord plug into hospital grade outlet
3. Connect hyperthermia blanket or pad
4. Turn power switch “ON”
Unit will go through an 8-10 second calibration cycle to test all indicators and will flash the
set point temperature of 37°C. Observe Water Flow Indicator on the side of the unit to verify
that the pump is circulating water when blanket/pad is connected. The unit will start heating
to a preset temperature of 37°C. To change the desired set point temperature, proceed to
step 5 below.
5. Depress the”TEMP SET” button. The display will flash the previous set point temperature
or the default temperature of 37°C if the unit has been turned OFF, and then back ON.
NOTE: You have five seconds to depress one of the arrows or the temperature readout will
return to the actual reservoir water temperature.
6. Depress the “UP” ▲or “DOWN” ▼arrow to raise or lower the set point temperature to the
desired setting.

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Draining Instructions:
1. Turn “OFF” power switch.
2. Connect drain hose to one of the outlet fittings and allow to gravity drain.
Alarm Conditions:
If an alarm sounds, check indicator lights or display for problem and take corrective
action.
Alarm may be silenced temporarily for five minutes by depressing the “Silence Alarm”
button.
The “Silence Alarm” button will not silence the alarm when “ERR” appears on the
display or “HIGH TEMP” indicator light comes on and does not flash. Power cord
should be removed from outlet and the unit sent to Biomedical Engineering for repair.
CAUTION:
This device should be operated only by trained personnel, under the direction of a
physician.
Patients vary in degree of sensitivity to cold, heat, and pressure.
The patient’s temperature and skin conditions should be checked at least every 20
minutes, or as directed by a physician, while on a thermal blanket.

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Section 1.Introduction
1-0. General Safety Precautions
To provide the patient maximum safety during the use of the NORM-O-TEMP®
hyperthermia system, a thorough knowledge and understanding of the system, and the
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 reviewed at least semi-
annually as a refresher to safe operation and application. For proper knowledge and
understanding, in-service training is available upon request. Failure to read,
understand, or follow operating manual could result in serious injury or death.
1-1. General Description of this Manual
This manual describes the operation, maintenance, and service of the NORM-O-TEMP®
hyperthermia system.
This manual is prepared for professional personnel who use the NORM-O-TEMP®
hyperthermia system for patient care as well as technicians and service personnel who
are responsible for maintaining the equipment. All personnel who operate or service
the unit should be familiar with all parts of this manual.
Physical and functional characteristics are described in Sections 1-3 and 1-5
1-2. Description of the NORM-O-TEMP® Hyperthermia System
Intended Use
The NORM-O-TEMP®Model 111W hyperthermia system is intended to prevent
hypothermia during surgical procedures and to reduce cold discomfort before, during,
and after a surgical procedure. The thermal regulating system is used to keep a patient
comfortable by maintaining blanket/pad water temperature through conductive heat
transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and
infant (includes neonates) patients to keep a patient at a comfortable temperature.
The NORM-O-TEMP®system is composed of a heater, circulating pump, and
blankets/pads. It is intended for use by appropriately trained healthcare professionals
in clinical environments.
Intended Environment
The NORM-O-TEMP®hyperthermia system is used in the Operating room, Post
Anesthesia Care Units, Recovery rooms, Intensive Care Units and Emergency Rooms.
The NORM-O-TEMP®hyperthermia system 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).

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NORM-O-TEMP, Model 111W
The NORM-O-TEMP®, Model 111W hyperthermia System is used to keep a patient
comfortable by maintaining blanket/pad water temperature through conductive heat
transfer. The NORM-O-TEMP® hyperthermia system is composed of a heater,
circulating pump, safety high limit, and microprocessor board.
Distilled water is heated and pumped from the unit to a blanket/pad. The blanket/pad
rests under, around, and/or on top of the patient. The water circulates through the
blanket/pad and returns to the unit. When warmed water is circulated through the
blanket/pad, the patient is warmed. The unit is designed to operate based on the
temperature of the circulating water.
The recommended blankets/pads for use are listed in Figure 16 Accessories.
1-3. Physical Description of the Norm-O-Temp®System
See Section 2 for specifications and certifications of the NORM-O-TEMP® system.
1-3.1. External Features and Descriptions –Front View
The external features in Figure 1 of the NORM-O-TEMP®unit are described as
follows:
A. The control panel is composed of pressure sensitive touch switches and an LED
display. An expanded description of the membrane control panel is presented in
Section 1-3.5.
B. The operating instructions printed below the control panel describe the
necessary steps to operate the unit.
C. The power switch is a bevel rocker switch labeled “I” (on) at the top and “O”
(off) at the bottom.
D. The four rubber feet help the unit to mount on the I.V. stand (Catalog #118), the
low profile stand (Catalog #119) or allow the unit to sit on any flat surface.
E. The water fill opening is where the operator pours distilled water to fill the
reservoir.
F. The red, Power Fail LED is the visual indicator when power is disconnected with
the switch still in its on position or when the independent mechanical (High
Limit) safety is activated.

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Figure 1. NORM-O-TEMP®unit, Front View

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1-3.2. External Features and Descriptions –Left Side View
The external features in Figure 2 of the NORM-O-TEMP®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 must pass 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
change in water flow decreases the speed of the paddle wheel.
The water flow indicator only spins when a blanket/pad or by-pass hose is
connected to the unit. It will not spin when water is circulated internally to pre-
condition the water. A total obstruction of the water path will cause the paddle
wheel to stop completely.
B. Two screws on the left and right side of the unit secures the top to the base.
C. Two female Hansen fittings, quick-disconnect return couplings, on the top row
are designed for water to flow in when the male coupling of the connecting hose
is attached.
D. Two male Hansen fittings, 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.
E. The recessed handle, one on each side, is provided to assist in lifting the unit on
and off the I.V. stand or when carrying the unit.

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Figure 2. NORM-O-TEMP® unit, Left Side View

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1-3.3. External Features and Descriptions –Rear View
The external features in Figure 3 of the NORM-O-TEMP®unit are described as
follows:
A. The specification label outlines the NORM-O-TEMP®unit's electrical
requirements.
B. Sets of air vents provide air circulation for the internal components.
C. The nylon straps are used to secure and store the coiled power cord and/or the
connecting hose when not in use.
D. The serial number printed on the Spec Label and located just above the power
cord.
E. Units have a power cord that can be disconnected and should only be inserted
into a properly grounded mating receptacle of a hospital grade specified by local
codes and practices. Electrical specifications are described in 0.
F. Ground Lug

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Figure 3. NORM-O-TEMP® unit, Rear View

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1-3.4. External Features and Descriptions –Right Side View
The external featuresin Figure 4 of the NORM-O-TEMP® unit are described as
follows:
A. The three sided enclosure panel, secured with eight screws, provides access to
the interior.
B. The recessed handle is one of two provided to assist in lifting the unit.
C. Two screws on the right and left side of the unit secure the top to the base.