Indications For Use; Safety Precautions - Gaymar Medi-Therm II Mode D'emploi

Medi-Therm
TM

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.
In rare instances, the cold temperature of the cooling
blanket 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 II
Hyper/Hypothermia Machine.
WARNING
!
• 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. Failure to notify the physician
promptly may result in serious injury or
death.
• When performing the PROBE CHECK, use a
protective sheath on the probe. Failure to use a
sheath could result in cross-contamination.
•
A physician's order is required for setting blanket
temperature and for continued use of equipment.
At least every 20 minutes or as directed by
a physician, check patient's temperature and
skin condition of areas in contact with blanket;
also, check blanket temperature. Pediatric,
temperature-sensitive, and operating room
patients should be checked more frequently.
Failure to monitor patient may result
in skin damage or inappropriate patient
temperature.
• Avoid placing additional heat sources between the
patient and blanket. Skin damage may result.
• Use only Gaymar probes (see Accessories, page 16)
or probes having characteristics equivalent to
YSI 400 series probes in the Patient Probe jack.
Use of other probes could result in
erroneous patient temperature values.
• Prevent excessive and/or prolonged tissue
pressure and shearing forces, especially over
boney prominences. Skin damage may result.
II
Indications/Safety Precautions
WARNING
!
• Keep the area between the patient and the blanket
dry. Excessive moisture may result in skin
damage.
• Do not tip machine over without first draining the
water out and unplugging the power cord. Damage
to the machine or electrical shock can result.
• Use of thermally conductive materials (e.g., water
or gel) on a patient when the Medi-Therm II is
switched off may decrease the patient's body
temperature.
• Repairs should be performed only by qualified
medical service personnel in accordance with this
product's service manual. Otherwise, damage to
the machine or improper therapy may result.
• 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. Patient burns may result.
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.
CAUTION
!
• For grounding reliability, plug only into a properly
grounded outlet.
• Fill with distilled water only. Do not use alcohol.
Do not operate without water. Do not overfill.
Overfilling may result in overflow when the
water in the blanket drains back into the
machine.
• Place a dry absorbent sheet between the patient
and the blanket when using all-vinyl blankets.
Moisture may accumulate which may result
in skin damage.
• The POWER LOSS INDICATOR battery may discharge
if the Medi-Therm II machine has not been used
for two months or more. The battery may not
become recharged until the machine has
operated for four hours.
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