User's Manual

User Manual – FloPatch FP120 Rev 1.0
CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. Page 6 / 33
3. SAFETY INFORMATION
3.1 Classification
The FloPatch FP120 is classified as a portable, internally powered device. It is a medical device intended
for use only by or under the order of trained medical professionals.
The device used with this device is a Type B Defibrillation Proof Applied Part.
Personnel operating this device are responsible for reading and thoroughly understanding all accompanying
documents. The device is not intended to be serviced by anyone other than trained personnel from
Flosonics Medical.
Statements throughout the accompanying documentation have the following significance:
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Explanation
WARNING! Indicates the possibility of personal injury to the Operator or Patient.
CAUTION! Indicates the possibility of damage to the product.
3.2 Warnings
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Explanation
WARNING! A single device is meant for single use on a single patient only. Attempting to re-
use a device can increase risk of cross contamination and cross infection.
WARNING! The device is an adjunct tool intended to aid in evaluation of cardiovascular
health. It is not intended to replace the current standards of care and diagnosis.
WARNING! The device is not intended to be used in oxygen rich and in the presence of
flammable anesthetics.
WARNING! The device is intended for intact skin only. Do not use the device on or near open
wounds.
WARNING! The device is not intended for MR environments. Using the device in an MR
environment may lead to a hazardous situation.
WARNING! The device is not provided sterile! The device should not be used in sterile
environments.
WARNING! Use of this device adjacent to or stacked with other equipment should be avoided
as it could result in improper operation. If such use is necessary, the device should be
observed to verify that they are operating normally.
WARNING! Use of accessories, devices and cables other than those specified or provided by
the manufacturer of this device could result in increased electromagnetic emissions or
decreased electromagnetic immunity of the device and result in improper operation.
WARNING! Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the FloPatch, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this device could occur.
WARNING! The FloPatch must be inspected before use for any damage to the adhesive. If
any damage is detected, the device must not be used.
WARNING! The device must not to be used at the same time as HF surgical equipment or in a
surgical environment. Doing so may create a hazardous situation.