Operation / Technical Manual
NORM-O-TEMP
®
, Model 111W
Page 13 of 82
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, 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-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).
