Charm Engineering Co. Ltd CAI001-BT33 Benutzerhandbuch
CORITICAL ACTIVITY INDEX
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2.6.5 CAI Device Label
Name of product classification: Electroencephalograph
Model (product name):
C
AI
Name of manufacturer: Charm Engineering Co., Ltd.
Address: Hyeongje-ro Namsa-myeon Cheoin-gu Yongin-si
Geonggi-do Korea
No. of Manufacturing: No. 5203
Product approval: CAI SYSTEM (Electroencephalograph, No.
16-4323)
Intended use: Device to record electrical activity signal of brain
by attaching at least 2 electrodes on the head region of patient
Manufacturing No. and Date: Indicated separately.
Weight and packaging unit: 1 Pack
Performance and how to use: See user manual
Precautions in use: See user manual
Product characteristics
Using internal power supply (rechargeable battery): Lithium
Polymer 3.7V, over 2,000mAh
Classification by type and degree of protection against elect ric
shock : Internal power type device, BF type installation part
This product is a “medical device”.