User and Technical Manual: HotDog Temperature Management Controller
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INTRODUCTION
Device Description
General Description:
The HotDog Patient Warming System consists of a Controller, reusable Warming Devices (e.g., Warming
Blankets, Warming Mattresses), and other accessories.
It is the responsibility of the clinician to determine whether warming is appropriate for each individual patient. The
System should not be used when clinical considerations indicate that warming of the patient is not advisable.
Core Temperature Monitoring / Auto Mode Description:
The Controller (WC7X) can measure patient core temperature from probes and function on AUTO mode whereby
the Controller self-adjusts warming temperature settings based on the patient’s core temperature.
The Controller can output the patient’s temperature to patient monitors in order to provide information to the
electronic medical record.
Indications for Use
General Indications for Use:
The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to
patients. The System should be used in circumstances in which patients could become cold. The System can be
used with adult and pediatric patients.
The System in intended primarily for use in hospitals and surgical centers including, without limitation, operating
rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.
Core Temperature Monitoring / Auto Mode Indications for Use:
The Controller (WC7X) is intended to measure patient core temperature from probes and function on AUTO mode
whereby the Controller self-adjusts warming temperature settings based on the patient’s core temperature.
The System monitors the YSI 400-compatible temperature probes, checking for a valid internal patient
temperature. YSI 400-compatible temperature probe parameters, such as patient body temperature values between
31°C and 43°C (inclusive) and valid slew rates of ±1°C per minute, are confirmed before allowing use in AUTO
Mode.
Contraindications
•
DO NOT warm ischemic or non-perfused tissue; thermal injury may result. Examples include tissue distal to
aortic cross clamping or when vasoconstrictive drugs would lead to severe, prolonged vasoconstriction.
•
DO NOT warm patients receiving transdermal medication; increased drug delivery may occur.
WARNINGS
General
•
EXPLOSION HAZARD
–
DO NOT
use the System in the presence of flammable anesthetics or highly
oxygen-enriched environments such as hyperbaric chambers, oxygen tents, etc.
•
Inspect System components prior to each use
for signs of damage or excessive wear such as cuts, holes, or
loose electrical connections or cold areas. If signs of wear are evident or if the warming device has been
subjected to extreme physical force (e.g. pinched by clamps or run over by carts), do not use the product until it
has been inspected by technical staff.
