Contraindications; Intended User Profile; Adverse Events; Warranty - CapsoVision CapsoAccess CDAS3 Instructions For Use Manual

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
damages of any kind. The above warranties are
in lieu of all other warranties either expressed
or implied including any warranty of any
merchantability or fitness for use.

2.7 Related Documents

CapsoView® Software Instructions for Use (IFU)
CapsoCam Plus® Instructions for Use (IFU)

3. Principle of Operation

3.1 CapsoAccess® Capsule Data Access System
The CapsoAccess® Capsule Data Access System
provides power inductively to the capsule. It can
4
be used either with capsules that have depleted
batteries or ones with still-active batteries and
flashing LEDs. The magnet on the lid of the system
opens the switch inside the capsule, disconnecting
the batteries from the inductive power.
The system and capsule communicate via a
bidirectional optical link, and the capsule
transfers the clinical data to the system.

4. Getting Started

4.1 Unpacking and Inspection
Upon receipt of the system, carefully remove
the contents from the box and check for visible
damage to components. If you see damage,
contact your local CapsoVision representative.
Save the shipping box and packaging until you
have successfully installed and verified correct
operation of the system. The original packaging
provides the best protection for return
shipment, if necessary.
4.2 Equipment supplied
The equipment supplied includes the
components listed below:
1. CapsoAccess® Capsule Data Access System
2. AC adapter
3. Power cable
4. USB cable
5. Instructions for Use
IFU-2800 Ref F 03/2020