LifeWatch V - Page 18

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Intended Use
The LifeWatch V is a medical device designed for self-testing in order to measure and display blood oxygen
saturation, blood glucose, ECG (1 lead), heart rate, body fat percentage, stress level analyzer and body
temperature. The LifeWatch V is intended for use in the following population groups:
 Adults
 Pediatrics as defined per medical module
The following applications of the LifeWatch V as described in this User Manual, are not within the scope of
the Medical Device Directive 93/42/EEC and are therefore not considered as medical devices, nor are they
covered by the this Directive:
 Stress Level Analyzer
 Diet Management
 Drug Management
 Body Fat Analysis
Test
Age Group
Pulse oximeter
Adults, 21 years and older
Blood Glucose meter
Adults and pediatrics above 12 years
Pediatrics below the age of 12 years: under adult supervision only
Excluding neonates and infants less than one year
1 Lead ECG
Adults and pediatrics above 12 years of age
Heart Rate
Adults and pediatrics above 12 years of age
Stress Level Analyzer
Adults, 21 years and older