User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual

1.11 BIOCOMPATIBILITY AND INFECTIONS CONTROL

No system component is intended to be in contact with the patient during the

usage.

Electrodes and sensors are not intended to be parts of the Bodyguardian Control

Unit product.

All the body contacting material are not part of the MD, in any case remember

that electrodes and sensors MUST meet the requirements of 93/42/EEC Medical

Devices Directive and its revised version (CE marked) for the European

Community and MUST have FDA clearance/approval for the U.S. market.

1.12 CAUTION FOR THE U.S. MARKET

Federal law (USA) restricts the device to sale by or on the order of a licensed

practitioner or therapist.

Medical professionals prescribe the Bodyguardian system to obtain physiological

data from their patients. It does not replace direct communication between

physicians and patients and does not summon physicians or emergency personnel.