General; Device Description; Indications For Use; Contraindications - CapsoVision CapsoAccess Instructions D'utilisation

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.
4

2.2 Indications for Use

This CapsoAccess® Capsule Data Access System
is intended for accessing data from the
CapsoCam Plus® capsule endoscopes. The
system may be used in hospitals, outpatient
clinics, and physician offices.

2.3 Contraindications

The CapsoAccess® Capsule Data Access System
has no known contraindications.

2.4 Intended User Profile

The CapsoAccess® Capsule Data Access System is
intended for use by trained medical personnel.

2.5 Adverse Events

The CapsoAccess® Capsule Data Access System
has no adverse events.

2.6 Warranty

CapsoVision warrants that the system is free from
defects in both materials and workmanship.
Suitability for use of the system for any procedure
shall be determined by the user. CapsoVision shall
not be liable for incidental or consequential
IFU-2800 Rev E 11/18