CSZ Norm-o-Temp 111Z User manual

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

Operation Manual NORM-O-TEM , 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 59425 Rev B
ECN M510-4952

Operation Manual NORM-O-TEM , 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 H
older
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 Manual NORM-O-TEM , 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, 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 – 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 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
•roper 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.
•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
®
unit 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 located in the Operation/Technical Manual 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.

Operation Manual NORM-O-TEM , Model 111Z
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WARNING
•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
otential electromagnetic interference may result.
•Always unplug the unit before accessing internal components during service Failure to
unplug the unit could result in electric shock.
•To avoid the risk of electric shock, this equipment must only be connected to a supply mains
with protective earth
•The repair, calibration, and servicing of the NORM-O-TEMP
®
unit 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-TEM
®
system and possible patient injury.
•Before returning the NORM-O-TEMP
®
unit to patient use after repairs, the FIRST TIME SET-
UP/SYSTEM TEST ROUTINE in the Operation/Technical Manual must always be performed
Improper repair and inadequate maintenance can result in damage to the NORM-O-TEM
®
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
•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.
•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
•Use of materials of good thermal conductivity, such as water, gel, and similar substances, with
the NORM-O-TEMP
®
system 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.
•Use only hospital grade plug or electric shock may result

Operation Manual NORM-O-TEM , Model 111Z
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CAUTION
•Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
professional
•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
®
system 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
®
system, 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

Operation Manual NORM-O-TEM , Model 111Z
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TABLE OF CONTENTS
Technical Help ..............................................................................................................................9
Before you call for Service ............................................................................................................9
In-Warranty Repair and Parts......................................................................................................... 9
Receiving Inspection ......................................................................................................................9
Important Safety Information .........................................................................................................9
NORM-O-TEMP
®
System Operating Instructions Quick Start Guide................................................. 10
Section 1 Introduction ......................................................................................................... 11
1-0 General Safety Precautions............................................................................................ 11
1-1 General Description of this Manual................................................................................ 11
1-2 Description of the NORM-O-TEMP
®
Hyperthermia System ............................................. 11
1-3 Physical Description of the NORM-O-TEMP
®
System ...................................................... 12
1-3 1 External Features and Descriptions – Front View ................................................... 12
1-3 2 External Features and Descriptions – Left Side View............................................... 14
1-3 3 External Features and Descriptions – Rear View..................................................... 16
1-3 4 External Features and Descriptions – Right Side View............................................. 18
1-3 5 External Features and Descriptions – Top View...................................................... 20
1-4 Required Accessories.................................................................................................... 22
1-5 Functional Description of the NORM-O-TEMP
®
System................................................... 22
1-5 1 Heating System..................................................................................................... 22
1-5 2 Circulating System ................................................................................................ 22
1-5 3 Temperature Safety Control System....................................................................... 23
Section 2 Specifications and Certifications ............................................................................ 24
Section 3 General Preparation of the NORM-O-TEMP
®
System............................................... 26
3-0 Introduction ................................................................................................................. 26
3-1 Unpacking the Shipment ............................................................................................... 26
3-2 First Time Set-Up / System Test Routine........................................................................ 26
3-2 1 Inspecting and Arranging the Equipment ............................................................... 26
3-2 2 Completing a System Test Routine......................................................................... 28
3-3 Unit and Patient Related Precautions............................................................................. 29
3-4 Patient Preparation and Bedside Care............................................................................ 30
3-5 Alarms and Error Displays ............................................................................................ 30
Section 4 Operating the NORM-O-TEMP
®
System .................................................................. 32
4-0 Introduction ................................................................................................................. 32
4-1 Arranging the System Components................................................................................ 32
4-2 Operating the NORM-O-TEMP
®
System.......................................................................... 33
4-3 Concluding the Use of the NORM-O-TEMP
®
System ........................................................ 34
Section 5 General Maintenance of the NORM-O-TEMP
®
System ............................................. 35
5-0 Introduction ................................................................................................................. 35
5-1 Maintenance of Water Reservoir ................................................................................... 37
5-1 1 Internal Clean using Bleach / Dry Storage Procedure.............................................. 37
5-1 2 Internal Cleaning and Disinfection Using Gigasept FF / Dry Storage Procedure ........ 39
5-1 3 Internal Cleaning and Disinfection Using Maranon H / Dry Storage Procedure......... 40
5-1 4 Draining the Reservoir .......................................................................................... 41
5-1 5 Replenishing the Reservoir / Fixing a Low Water Alarm ......................................... 42
5-2 Maintenance of the Water Filter .................................................................................... 42
5-3 Maintenance of the NORM-O-TEMP® Exterior – Cleaning Instructions............................ 43
5-4 Maintenance of the Hyper-Hypothermia Blanket / Pad(s)............................................... 44
5-4 1 Cleaning / Maintenance of Reusable Blanket / Pad(s)............................................. 44
5-4 2 Cleaning / Maintenance of Disposable, Single-Patient Use Blanket / Pad(s) ............. 44

Operation Manual NORM-O-TEM , Model 111Z
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TABLE OF FIGURES
Figure 1 NORM-O-TEMP
®
unit, Front View 13
Figure 2 NORM-O-TEMP
®
unit, Left Side View 15
Figure 3 NORM-O-TEMP
®
unit, Rear View 17
Figure 4 NORM-O-TEMP
®
unit, Right Side View 19
Figure 5 NORM-O-TEMP
®
unit, Model 111Z Top View 21
Figure 6 NORM-O-TEMP
®
, Model 111Z Features 25
Figure 7 NORM-O-TEMP
®
Maintenance Checklist 36
Figure 8 NORM-O-TEMP
®
System Accessories 45

Operation Manual NORM-O-TEM , Model 111Z
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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 csz@genthermcsz com
Visit our Web Site at 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 arts
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
Reference the Operation/Technical manual for service instructions

Operation Manual NORM-O-TEM , Model 111Z
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NORM-O-TEM
®
System 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 Fill reservoir with distilled water
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 42°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 42°C/107°F 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 42°C/107°F 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
7 Select the desired temperature scale using the “C/F” button (Celsius or Fahrenheit)
Draining Instructions:
1 Turn “OFF” power switch
2 Allow gravity to drain the water back into the unit from the blanket/pad
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