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
Page 2 of 50
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
Page 3 of 50
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
Page 4 of 50
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
Page 5 of 50
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
Page 6 of 50
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
Page 7 of 50
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
Page 8 of 50
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
Page 9 of 50
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
Page 10 of 50
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

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 11 of 50
Section 1.Introduction
1-0. General Safety recautions
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-TEM
®
Hyperthermia System
Intended Use
The NORM-O-TEMP
®
Model 111Z 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)

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 12 of 50
NORM-O-TEM , Model 111Z
The NORM-O-TEMP
®
, Model 111Z 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 8 Accessories
1-3. hysical Description of the NORM-O-TEM
®
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 a 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

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 13 of 50
Figure 1. NORM-O-TEM
®
unit, Front View

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 14 of 50
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) when water returns to the
NORM-O-TEMP
®
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 stand or when carrying the unit

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 15 of 50
Figure 2. NORM-O-TEM
®
unit, Left Side View

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 16 of 50
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 disconnectable power cord 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 Section 3

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 17 of 50
Figure 3. NORM-O-TEM
®
unit, Rear View

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 18 of 50
1-3.4. External Features and Descriptions – Right Side View
The external features in 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

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 19 of 50
Figure 4. NORM-O-TEM
®
unit, Right Side View

Operation Manual NORM-O-TEM
®
, Model 111Z
Page 20 of 50
1-3.5. External Features and Descriptions – Top View
The membrane control panel as shown in Figure 5 is composed of pressure sensitive touch
switches and LED displays
The membrane control panel is divided into the following sections:
A The four digit LED display shows the actual water temperature and set point temperature
The temperature can be displayed in Celsius or Fahrenheit
B When the HEAT LED is lighted, it indicates that the water is being heated
C The HI TEMP LED will flash and the audible alarm will sound when the water
temperature reaches 43 5°C ± 0 6°C (110°F ± 1 08°F)
The HI TEMP LED will illuminate and the audible alarm will sound when the water
temperature reaches 44 5°C ± 0 6°C (112°F ± 1 08°F)
The HI TEMP LED will illuminate, the power fail LED will illuminate and the audible
alarm will sound when the water temperature reaches 46 0°C ± 0 6°C (115°F ± 1 08°F)
D When the LO WATER LED is lit it indicates that the unit needs more distilled water to
operate The LED will be accompanied by an audible alarm
E The SILENCE ALARM button will silence the primary HI TEMP and LO WATER audible
alarms for five minutes and if the problem is not solved, the alarm will sound again until
the button is pressed or the problem is solved
F The TEMP SET button is used to display the desired water temperature When this
button is pressed, the display will flash the set point temperature for five seconds
G The INCREMENT and DECREMENT buttons are used to raise or lower the set point
temperature There is a five second interval to set the temperature up or down after
pressing the TEMP SET button
H The C/F button allows the operator to select the measurement scale, Celsius or Fahrenheit,
by which the unit functions
I The operating instructions allow the operator to clearly see the directions and efficiently
use the unit
J The fill reservoir lid slides to the left to open and to the right to close