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Intended Users and Patient Target Group:
The Temperature Probe is intended for use by skilled physicians and technologists trained in the
specialty of Electrodiagnostic testing.
The target patient population is the pediatric and adult patient population requiring Electrodiagnostic
testing.
Clinical Benefits:
The Temperature Probe allows monitoring of a patient’s skin surface temperature throughout an
Electrodiagnostic test, such as Electromyography (EMG) and Nerve Conduction Studies (NCS). This
information can be useful criteria in interpretation of the test results. The Temperature Probe is used
at the discretion of the clinical provider.
Contraindications and Side Effects:
There are no known contraindications or side effects for procedures performed with the Temperature
Probe.
Operating Instructions:
1. Secure the Temperature Probe’s sensor disc to an appropriate location on the patient’s skin.
2. Connect the Temperature Probe to the Temperature Probe Connector on the Nicolet EMG
amplifier.
Cleaning Instructions:
1. Clean with a commercial wipe such as CaviWipes
TM
or Sani-Cloth
®
to remove visible soil.
2. Wipe the article using a lint-free cloth and air dry.
3. The cleaning procedure must be in accordance with your local facility’s guidelines. The
user/operator shall clean the device after every use.
Understanding Warning and Caution Statements:
WARNING
Refers to a hazardous situation that could result in death or serious injury if not avoided.
•
Information on how the hazardous situation is avoided.
CAUTION
Refers to a hazardous situation that could result in minor or moderate injury or material damage
if not avoided.
•
Information on how the hazardous situation is avoided.
Содержание EMG
Страница 101: ...1 7 EMG Surface Temperature Probe Nicolet Nicolet EMG NCS 1 2 Nicolet 1 CaviWipes Sani Cloth 2 3...
Страница 102: ...2 7 Natus 15 6 C 32 2 C 60 F 90 F 20 80 0 3 0 10 000 17 7 C 55 C 0 F 132 F 10 90 0 10 668 0 35 000...
Страница 105: ...5 7 21 CFR 801 109 b 1 ISO 15223 1 5 4 5 2012 19 EE ISO 15223 1 5 1 1 ISO 15223 1 5 1 2 ISO 15223 1 5 1 3...
Страница 107: ...7 7 MDR 2017 745 CE ISO 15223 1 5 2 8 ISO 15223 1 5 3 7 ISO 15223 1 5 3 8 033125_03 02 2021...