Medi-Therm®III
1.0 Indications for Use
For the prevention or treatment of hyperthermia/
hypothermia.
1.1 Contraindications
Patients with an elevation of cold agglutin levels (cold
agglutinemia) should not be placed on a cooling blanket/
body wrap.
In rare instances, the cold temperature of the cooling
blanket/body wrap may lead to acrocyanosis and
necrosis of distal body structures (Talisman, R., et al.
Surgery 123(5): 592-595 (1998).
2.0 Safety Precautions
Read and understand this operating manual and all
precautions listed below prior to using the Medi-Therm
III Hyper/Hypothermia Machine.
• If the patient’s temperature is not responding or
does not reach the prescribed temperature in the
prescribed time or deviates from the prescribed
temperature range, notify the attending physician
promptly.Failuretonotifythephysician
promptlymayresultinseriousinjuryor
death.
• When performing the PROBE CHECK, use a
protective sheath on the probe. Failuretousea
sheathcouldresultincross-contamination.
• A physician’s order is required for use of
equipment. Check the integrity of the skin
according to department protocol when
regulating temperature with external devices.
Frequency of assessment and documentation will
vary depending upon the individual response of
the patient.
Failuretomonitorpatientmayresult
inskindamageorinappropriatepatient
temperature.
•Avoid placing additional heat sources between the
patient and blanket/body wrap.Skindamage
mayresult.
• Use only Gaymar probes (see Accessories, page 16)
or equivalentYSI 400 series probes approved for
use with medical devices in the Patient Probe jack.
Useofotherprobescouldresultin
erroneouspatienttemperaturevalues.
• Prevent excessive and/or prolonged tissue
pressure and shearing forces, especially over
boney prominences.Skindamagemayresult.
•Keep the area between the patient and the blanket/
body wrap dry.Excessivemoisturemayresult
inskindamage.
• Donottipmachineoverwithoutrstdrainingthe
water out and unplugging the power cord. Damage
tothemachineorelectricalshockcanresult.
• Use of thermally conductive materials (e.g., water
or gel) on a patient when the Medi-Therm III
is switched off may decrease the patient's body
temperature.
• Repairsshouldbeperformedonlybyqualied
medical service personnel in accordance with this
product's service manual.Otherwise,damageto
themachineorimpropertherapymayresult.
• All wire-lead, patient-connected transducer
assemblies are subject to reading error, local heating,
and possible damage from high-intensity sources of
RF energy. Inadequately grounded electrosurgical
equipment represents one such source, since
capacitively-coupled currents may seek alternate
paths to ground through probe cables and associated
instruments. Patientburnsmayresult.
If possible, remove the probe from patient contact
before activating the surgical unit or other RF
source. If probes must be used simultaneously with
electrosurgical apparatus, hazards can be reduced by
selecting a temperature monitoring point which is
remote from the expected RF current path to the
ground return pad.
• When using the rate controlled Auto Moderate or
Auto Gradual modes for warming; switching to other
modes, e.g.Auto Rapid or Manual, or changing the
temperature set point during the therapy will cause
the Medi-Therm to reset the therapy. Alteringthe
ModeorTemperaturesetpointmayimpact
theoveralldurationofthetherapy.
Indications/Safety Precautions
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