Warnings And Safety Precautions; General; Device Description; Indications For Use - CapsoVision CapsoAccess CDAS3 Bedienungsanleitung

1. Warnings and
Safety Precautions
The CapsoAccess® Capsule Data Access System
(CDAS3) has been constructed in accordance
with US (FDA), Canada (CSA) and international
(European MDD) regulations and standards for
operation of electrical equipment,
electromagnetic compatibility, and stipulated
safety requirements.
To prevent accidental damage to the
equipment, and to ensure safe, trouble-free
operation, please read and follow these
operating instructions carefully before using the
system. Keep these instructions in a safe place.
Do not modify this equipment without
authorization of the manufacturer.
Operators should always wear gloves when
handling the capsules and system.
WARNING! Do not open
AC adapter. Risk of electric shock.
To avoid risk of electric shock, this equipment
must only be connected to grounded electrical
outlets.
Keep liquids out of the system interior. Do not
submerge or autoclave.
Clean exterior surfaces with a cloth and swab
moistened with disinfectant.
Clean, disinfect and completely dry the capsule
prior to inserting it into the system.
Use only the supplied medical grade power supply.
A medical grade power supply is required for use
in devices intended for medical applications.
This unit only complies to regulatory standards if
used with the supplied medical grade power cord.
Before unplugging the CapsoAccess® system,
make sure the unit is powered OFF.
Power cord is used as a disconnection device.
To de-energize equipment, disconnect the
power cord.
Per manufacturer' s declaration all USB ports are
for exclusive connection to IEC 60601-1 certified
equipment when it is placed within a patient
environment.
It should not be used with life-support systems.

2. General

2.1 Device Description

The CapsoAccess® Capsule Data Access System
enables trained medical personnel to extract
in-vivo data from the CapsoCam Plus® capsule.
The system transfers the data to a computer
running the CapsoView® software.
The system is not intended for use by patients or
on patients and is not intended to interact with
any part of the body or any type of body tissue.

2.2 Indications for Use

This CapsoAccess® Capsule Data Access System
is intended for accessing data from the
CapsoCam Plus® capsule endoscopes. The
IFU-2800 Ref F 03/2020
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