User's Manual

Document Title
C-Scan System User Reference Manual
Document No. DOC0001667 Revision 14 Date 22 May 2022
Page 12 of 90
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 During and after the procedure the subject should not immerse the C-Scan
®
Track
in any liquid (no- bath, pool, Jacuzzi and swimming).
 During the procedure the subject should not travel by airplane.
 During the procedure the subject should not perform any active or contact sport
(such as running, Jogging, physical training in the gym, ball games, Skiing, contact
sports).
 This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
Product related:
 C-Scan
®
Cap are MR unsafe thus C-Scan
®
Cap excretion shall be verified before
subject undergo MRI procedure.
 CT image may be impaired by the presence of the capsule thus if abdominal CT is
required it shall be performed after C-Scan
®
Cap excretion.
 The C-Scan
®
Cap includes radiation source thus it should be kept in the dedicated
package until the procedure.
 The C-Scan
®
Cap should be stored in a safe place, out of the reach of children and
infants.
 If a child has accidentally swallowed the C-Scan
®
Cap seek immediate medical help.
 Do not use the C-Scan
®
kit after its expiry date indicated on the Kit.
 If there is a doubt concerning the integrity of the C-Scan
®
Cap for example due to
dropping or biting, the C-Scan
®
Cap should be returned to its original package and
it should not be used.
 Instruct the subject to avoid biting the C-Scan
®
Cap prior to swallowing.
 C-Scan
®
Cap should be ingested only in the presence of authorized medical
personnel.
 Activation of the C-Scan
®
Track shall be done when the C-Scan
®
Cap and C-Scan
®
Track are placed in their dedicated location inside package.
 The C-Scan
®
Cap shall be ingested only after successful initialization indication from
the C-Scan
®
Track.
 Subject shall contact the clinic team in case an alarm in on (Malfunction indication
include a vibration with repeated beeps and a red LED will light up on the C-Scan
®
Track).
 The C-Scan
®
Track shall not be exposed to intense sunlight or high temperature.
 The C-Scan
®
Cap cannot be thrown into the trash or be flushed in the toilet.
 Do not connect the cable between the C-Scan
®
Track and the C-Scan
®
View while
the system is still attached to the subject's back.
 Do not disassemble batteries or C-Scan
®
track with batteries inside.