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The Seiratherm GmbH tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients.

The Seiratherm tempedy System is an adjunct to normalizing the body temperature of adults. It is intended to be used in situations when the patient is hypothermic and requires warming or when the patient is hyperthermic and requires cooling. 1. It is an intravenous fluid cooling system 2. It is an intravenous fluid warming system 3. It is a thermal regulating system with feedback of patient's temperature The tempedy System does not deliver drugs. It is not a drug infusion device. The tempedy System does not deliver colloids (blood products, plasma, lipids, etc.) It is only for delivery of crystalloids (normal saline, Ringers, etc.). The tempedy System includes the following accessories: Power cord, Tubg Set, and Temperature Probe. A list of accessories is on Page 50 of the Instructions for Use Manual. Patient contacting parts: The sterile "Tubing Set T0" is a patient contacting part of the system. The Tubing Set TO is a single use part in the tempedy System. The GE Healthcare, K051873, M1024231 GP Temperature Probe, Adult YS1 400 compatible temperature probe is also a patient contacting part of the system. It is a manufacturer sterilized, single use part.