ZOLL Thermogard HQ Surface Start-Up Kit Instructions For Use

ZOLL Thermogard HQ™ Surface Start-Up Kit Instructions For Use
Device Description
The Thermogard HQ™ Surface Start-Up Kit is a tubing set that connects the Thermogard HQ™ console to the ZOLL surface pad (surface
pad). The Thermogard HQ Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension
tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water
to the surface pad to regulate patient core temperature.
Indications for Use
Temperature reduction in adult patients where clinically indicated, e.g. in hyperthermic patients.
Intended Purpose
The Thermogard HQ Surface Start-Up Kit intends to lower patient temperature.
Intended User
Intended Users for Thermogard HQ Surface Start-Up Kit include physicians, physician assistants, and nurses.
Clinical Benefits
The primary clinical benefit of the Thermogard HQ Surface Start-Up Kit, used as part of the Thermogard system, is to lower body tempera-
ture.
Note:
Refer to the Thermogard HQ Console Operations Manual and the ZOLL surface pad Instructions for Use for a full listing of Indications, Con-
traindication, Warnings, Cautions, and additional information.
Contraindications
None known.
Warnings
• Read these instructions for use carefully before connecting the surface pad to a patient.
• Systemic hypothermia risks. Systemic hypothermia may cause cardiac arrhythmia, patient shivering, or other system or organ complica-
tions. Systemic hypothermia should only be utilized under the supervision of a qualified physician.
• Thermogard HQ Surface Start-Up Kits (non-sterile) are not compatible with intravascular catheter use (sterile).
The patient's temperature and skin condition must be checked, especially areas in contact with the surface pad, every 20 minutes or as
•
directed by a physician. Patients vary in degree of sensitivity to cold, heat and pressure. Patients at greatest risk are those unconscious or
incapacitated, persons on prolonged therapy, diabetics, children, persons with sensitive skin areas or poor circulation.
• Focus attention on all bony prominences.
• When a Thermogard HQ console is used with a Thermogard HQ Surface Start-Up Kit and surface pad, the Treatment Mode should set
to Fever Control. The console does not warm the patient when Fever Control mode is selected. The Lo patient temperature alarm limit
ensures that an alarm occurs should the patient stop regulating his/her own body temperature. Such patients cool to room temperature.
This can occur when the patient dies or becomes comatose. Investigate all patient temperature alarms.
Cautions
• U.S. federal law restricts the device to sale on or by the order of a physician.
• Thermogard HQ Surface Start-Up Kits are not sterile and are intended for single patient use. Do not reuse, reprocess or sterilize.
• The cyclical stresses of the roller pump on these items cause fatigue failures. Do not use Thermogard HQ Surface Start-Up Kits beyond
the labeled usage time. The products will fail.
• Use care when fitting the surface pad to the patient. When priming is complete, continue to flow water through the surface pad before
fastening the surface pad to the patient. Once water is fully flowing through the surface pad, it may be secured to the patient.
• Failure to connect both connectors to the surface pad may result in overpressure and leaks in the Thermogard HQ Surface Start-up Kit or
surface pad.
• If you notice a depleted reservoir bag or an air trap alarm, do not replace the water prior to identifying the location of the leak and
taking the appropriate mitigation. Check for leaks in the Thermogard HQ Surface Start-Up Kit and the surface pad. If a leak is found,
replace as necessary. If the surface pad is replaced, the Thermogard HQ Surface Start-Up Kit reservoir bag may be refilled with additional
water as required.
Operating Life
Caution. Thermogard HQ Surface Start-Up Kit lifetime is 30 days. The designed operating lifetime for these components is 30 days of con-
tinuous operation on a single patient. If a patient must be treated for a longer period, a new Thermogard HQ Surface Start-Up Kit must be
installed in the console. Failure to adhere to this time limit may cause the device to fail.
Setup Instructions
1. Initiate Console
1.0 Power on the console.
1.1 Select "Cooling" for intended treatment.
1.2 Choose New Patient (Yes or No).
Choose No if continuing a prior treatment.
1.3 Select Target Temperature.
1.4 Select "Fever Control" mode.
Caution: Always use "Fever Control" mode when using Thermogard Surface treatment.
106875-002 Rev. 4
6/2024