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
Page 2 of 82
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

Operation/Technical Manual NORM-O-TEMP®, Model 111W
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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.

Operation/Technical Manual NORM-O-TEMP®, Model 111W
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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.