CSZ NORM-O-TEP 111Z User manual

Operation / Technical Manual
Model 111Z 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 111Z
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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 2016 Cincinnati Sub-Zero Products, LLC. All rights reserved.
Manual 59225 Rev. F
ECN M1902-5543

Operation / Technical Manual NORM-O-TEMP, Model 111Z
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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

Operation / Technical Manual NORM-O-TEMP, Model 111Z
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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, and diabetic patients are at greater risk for developing
tissue injuries, and this should be considered when selecting the temperature, duration of
therapy and frequency of skin checks. 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 – Infants’ 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. The clinician is
responsible for determining the appropriateness of the temperature limits in dependency to
time. Exceeding 40°C water temperature for extended periods can cause tissue damage and
burns. Clinical judgment should be used to determine the safe maximum contact periods
based on patient age, clinical condition, and current medications. 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.

Operation / Technical Manual NORM-O-TEMP, Model 111Z
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•
•
•Do not use the NORM-O-TEMP®system in the presence of flammable anesthetics. Risk of
explosion can result.
•The warming of transdermal medications (patches) can increase drug delivery, resulting
in possible injury to the patient.
•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.
•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.
•Thermal injury may occur if heating/cooling therapy is applied to ischemic limbs.
•Use only hospital grade plug or electric shock may result.

Operation / Technical Manual NORM-O-TEMP, Model 111Z
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CAUTION
•Federal law 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) 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.
•This 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.............................................................................................................................12
1-0. General Safety Precautions............................................................................................................................12
1-1. General Description of this Manual............................................................................................................12
1-2. Description of the NORM-O-TEMP®Hyperthermia System ............................................................12
1-3. Physical Description of the NORM-O-TEMP®System ........................................................................13
1-3.1. External Features and Descriptions – Front View ..........................................................................13
1-3.2. External Features and Descriptions – Left Side View....................................................................15
1-3.3. External Features and Descriptions – Rear View............................................................................17
1-3.4. External Features and Descriptions – Right Side View.................................................................19
1-3.5. External Features and Descriptions – Top View .............................................................................21
1-4. Required Accessories.......................................................................................................................................23
1-5. Functional Description of the NORM-O-TEMP®System ...................................................................23
1-5.1. Heating System..............................................................................................................................................23
1-5.2. Circulating System .......................................................................................................................................23
1-5.3. Temperature Safety Control System.....................................................................................................24
SECTION 2. SPECIFICATIONS AND CERTIFICATIONS...............................................................................25
SECTION 3. GENERAL PREPARATION OF THE NORM-O-TEMP®SYSTEM.........................................27
3-0. Introduction.........................................................................................................................................................27
3-1. Unpacking the Shipment ................................................................................................................................27
3-2. First Time Set-Up / System Test Routine................................................................................................27
3-2.1. Inspecting and Arranging the Equipment ..........................................................................................27
3-2.2. Completing a System Test Routine........................................................................................................30
3-3. Unit and Patient Related Precautions.......................................................................................................31
3-4. Patient Preparation and Bedside Care......................................................................................................32
3-5. Alarms and Error Displays ............................................................................................................................32
SECTION 4. OPERATING THE NORM-O-TEMP®SYSTEM.........................................................................34
4-0. Introduction.........................................................................................................................................................34
4-1. Arranging the System Components ...........................................................................................................34
4-2. Operating the NORM-O-TEMP®System....................................................................................................35
4-3. Concluding the Use of the NORM-O-TEMP®System............................................................................36
SECTION 5. GENERAL MAINTENANCE OF THE NORM-O-TEMP®SYSTEM ........................................37
5-0. Introduction.........................................................................................................................................................37
5-1. Maintenance of Water Reservoir ................................................................................................................39
5-1.1. Internal Cleaning using Bleach / Dry Storage Procedure............................................................39
5-1.2. Internal Cleaning & Disinfecton Using Gigasept FF / Dry Storage Procedure ....................................41
5-1.3. Internal Cleaning & Disinfection Using Maranon H / Dry Storage Procedure....................................42
5-1.4. Draining the Reservoir...............................................................................................................................43
5-1.5. Replenishing the Reservoir / Fixing a Low Water Alarm ............................................................44
5-2. Maintenance of the Water Filter .................................................................................................................44
5-3. Maintenance of the NORM-O-TEMP®Exterior & Vents – Cleaning Instructions ....................46
5-4. Maintenance of the Hyper-Hypothermia Blanket / Pad(s)..............................................................46
5-4.1. Cleaning / Maintenance of Reusable Blanket / Pad(s) .................................................................46
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

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6-0. Introduction.........................................................................................................................................................48
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..................................................55
6-9. Calibration of the Independent High Limit Safety Thermostat......................................................56
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........................................61
6-17. Electrical Safety..................................................................................................................................................62
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...................................................................................................................14
Figure 2. NORM-O-TEMP® unit, Left Side View ............................................................................................................16
Figure 3. NORM-O-TEMP®unit, Rear View ....................................................................................................................18
Figure 4. NORM-O-TEMP® unit, Right Side View .........................................................................................................20
Figure 5. NORM-O-TEMP® unit, Model 111Z Top View ............................................................................................22
Figure 6. NORM-O-TEMP®, Model 111Z Features.......................................................................................................26
Figure 7. NORM-O-TEMP®Maintenance Checklist.....................................................................................................38
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 a 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.