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General Information
ME (Medical Electrical) Equipment Application Specifi cations
Medical Purpose
1. This device measures (evaluates) momentary maximum grip strength, and
endurance grip strength.
2. Use during examination, diagnosis, treatment, and monitoring of patient
disorders and diseases (hand injuries, etc.).
Patient Population
1. Ages: From children (at age 6) to the elderly
2. Nationality: Multiple
3. Patient state: Irrelevant except when patient feel nervous
Part of the Body or Type of Tissue in contact during usage
1. Measurement site: Both hands
2. Condition: Patient should be able to fold and spread out their fi ngers
Intended Operators - Professional Health Care Provider (Physical Therapists, etc.)
1. Education:
– Those qualifi ed with expertise in rehabilitation therapy and orthopedics
– No maximum
2. Knowledge:
– English or German (IFU languages provided)
– Knowledge of IFU languages is not necessary
3. Experience:
– Minimum: No special experience needed
– No maximum
4. Permissible impairments:
– Mild reading vision impairment or vision corrected to log MAR 0.2 (6/10
or 20/32)
– 40% of disability causing 60% of normal hearing in the range of 500 Hz ~
2 kHz
DHD-1 Digital Hand Dynamometer – General Information
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