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