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ZOLL Thermogard HQ™ Surface Start-Up Kit
Device Description
The Thermogard HQ™ Surface Start-Up Kit is a tubing set that connects the Thermogard HQ console to the STx™ Vest 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 is to lower body temperature.
Note:
Refer to the Thermogard HQ Console Operations Manual and the STx Vest Instructions for Use for full listing of Indications, Contraindication,
Warnings, Cautions, and additional information.
Contraindications
None Known.
Warnings
• Read these instructions for use carefully before connecting pads to a patient.
• Systemic hypothermia risks. Systemic hypothermia may cause cardiac arrhythmia, patient shivering, or other system or organ
complications. 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 pad(s), 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 STx Vest, the Treatment Mode is set to
Fever Control. The console does not warm the patient when the 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 pad to the patient. When priming is complete, continue to flow water through the pad before fastening
pad to the patient. Once water is fully flowing through the pad, it may be secured to the patient.
• Failure to connect both connectors to the 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 STx Vest surface pad.
If a leak is found, replace as necessary. If the Vest 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 seven days. The designed operating lifetime for these components is seven (7)
days of continuous 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 whether new patient
1.3 Select Target Temerature
1.4 Select "Fever Control" mode
Caution: Always use "Fever Control" mode when using Thermogard Surface treatment.
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106875-002 Rev. 2 01/2024
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