Operation Manual
NORM-O-TEMP, Model 111W
Page 11 of 26
Section 1.
Introduction
1-0.
General Safety Precautions
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, 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. All personnel who operate or service the unit should
be familiar with all parts of this manual.
Physical characteristics are described in Section 1-3.
1-2.
Description of the NORM-O-TEMP
®
Hyperthermia System
Intended Use
The NORM-O-TEMP
®
Model 111W 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).
NORM-O-TEMP
®
, Model 111W
The NORM-O-TEMP
®
, Model 111W 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.
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