Check Cap TRACK10007605 C-Scan track transceiver User Manual Title

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C-Scan® System
User Reference Manual
Revision 10
Rx Only
CEpartner4U BV
Esdoornlaan 13
3951 DB Maarn
The Netherlands
Check-Cap LTD
29 Abba Hushi Ave.
P.O. Box 1271
Isfiya, 3009000
Israel
Document Number: DOC000300
INFORMATION IN THIS DOCUMENT IS PROVIDED IN CONNECTION WITH CHECK CAP PRODUCTS. NO
LICENSE, EXPRESS OR IMPLIED, BY ESTOPPEL OR OTHERWISE, TO ANY CHECK CAP INTELLECTUAL
PROPERTY RIGHTS IS GRANTED BY THIS DOCUMENT. EXCEPT AS PROVIDED IN CHECK CAP’S TERMS AND
CONDITIONS OF SALE FOR SUCH PRODUCTS, CHECK CAP ASSUMES NO LIABILITY WHATSOEVER, AND
CHECK CAP DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTY, RELATING TO SALE AND/OR USE OF
CHECK CAP PRODUCTS INCLUDING LIABILITY OR WARRANTIES RELATING TO FITNESS FOR A
PARTICULAR PURPOSE, MERCHANTABILITY, OR INFRINGEMENT OF ANY PATENT, COPYRIGHT OR OTHER
INTELLECTUAL PROPERTY RIGHT.
Check Cap products are not intended for use in life saving or life sustaining applications.
Contact Check Cap to obtain the latest specifications and before placing your product order.
Check Cap, C-Scan®, and the Check Cap logo are registered trademarks of Check Cap Corporation or its
subsidiaries in the United States and other countries.
*Other names and brands may be claimed as the property of others.
Copyright © 2016, Check Cap Corporation. All rights reserved.
DOC000300 / C-SCAN User Reference Manual
Contents
Using This Guide........................................................................................... 8
1.1
1.2
1.3
Indications, Contraindications, Warnings, Cautions ........................................... 9
2.1
2.1
2.2
2.3
2.4
2.5
2.6
2.7
Purpose ............................................................................................ 8
Abbreviations, Acronyms, and Definitions ............................................. 8
Conventions ...................................................................................... 8
Intended Use .................................................................................... 9
Intended Users, Patients and Environments (e.g. home use, outside) ....... 9
Contraindications ............................................................................... 9
Potential Adverse Events .................................................................. 10
Warnings ........................................................................................ 10
Cautions ......................................................................................... 12
Benefits and Risks—C-Scan® System.................................................. 13
2.6.1
Benefits ............................................................................. 13
2.6.2
Risks ................................................................................. 13
Accuracy of the Imaging Performance ................................................ 14
Welcome to the C-Scan® System .................................................................. 15
3.1
3.2
3.3
3.4
3.5
3.6
3.7
What is the C-Scan® System? ........................................................... 15
The C-Scan® System Process ............................................................ 15
C-Scan® System Components ........................................................... 15
C-Scan® Cap ................................................................................... 16
Handling the C-Scan® Cap ................................................................ 17
C-Scan® Track ................................................................................. 18
C-Scan® View .................................................................................. 19
C-Scan® View Installation Guide ................................................................... 20
Planning and Performing a C-Scan® Capsule Procedure ................................... 30
5.1
5.2
5.3
5.4
5.5
5.6
Using C-Scan® View to Create the C-Scan® Reconstructed Colon Display ........... 44
6.1
6.2
6.3
6.4
6.5
Physician’s Preliminary Meeting with the Patient .................................. 30
5.1.1
Guidelines for Determining Patient Suitability for the C-Scan®
Procedure .......................................................................... 31
5.1.2
Planning the Procedure with the Patient ................................. 31
5.1.3
Order the C-Scan® System .................................................. 32
Day of Procedure Meeting with the Patient .......................................... 32
5.2.1
Physician’s Pre-procedure Meeting ........................................ 32
5.2.2
Preparing the Patient for the Procedure ................................. 34
Ingesting the Capsule ....................................................................... 39
During the Procedure ....................................................................... 41
End of Procedure ............................................................................. 41
Post-procedure ................................................................................ 42
5.6.1
Patient Post-procedure Actions ............................................. 42
5.6.2
Technician Post-procedure Actions ........................................ 42
5.6.3
Physician Post-procedure Actions .......................................... 43
C-Scan® Track Download .................................................................. 45
Loading and Processing C-Scan® Track Data ....................................... 46
Viewing a 3D Reconstruction from a CD .............................................. 48
Backing Up Data .............................................................................. 50
User Settings .................................................................................. 50
Reviewing and Interpreting the C-Scan® 2D/3D Images ................................. 52
DOC000300 / C-SCAN User Reference Manual
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
7.10
7.11
7.12
Understanding the Navigation Bar ...................................................... 52
Review Screens – General ................................................................. 52
Action Icons .................................................................................... 59
Segment Control.............................................................................. 60
Slice Control.................................................................................... 60
Segment Timeline ............................................................................ 60
2D Map Mode .................................................................................. 60
3D View Mode ................................................................................. 61
7.8.1
3D Tube Mode .................................................................... 61
7.8.2
Fly Through Mode ............................................................... 62
7.8.3
Fillet Mode ......................................................................... 63
Motility Information.......................................................................... 63
Evaluating Suspects ......................................................................... 65
Results Screen – General .................................................................. 77
Imaging Data Validity ....................................................................... 78
Creating a C-Scan® System Report ............................................................... 80
8.1.1
8.1.2
8.1.3
Patient Field ....................................................................... 80
Procedure Field .................................................................. 80
Physician Comment Fields.................................................... 81
Ordering the C-Scan® Kit and Disposing of the Used Components ..................... 85
9.1
9.2
10
Ordering the C-Scan® Cap ................................................................ 85
9.1.1
Before Ordering .................................................................. 85
9.1.2
Ordering ............................................................................ 85
Returning the C-Scan® Cap ............................................................... 86
Technical Description .................................................................................. 87
10.1
System Labeling .............................................................................. 87
10.2
C-Scan® Kit Labels ........................................................................... 89
10.3
C-Scan® Cap Label ........................................................................... 90
10.4
C-Scan® Track Label ........................................................................ 90
10.5
C-Scan® View Labels ........................................................................ 91
The C-Scan® View has four labels. 3 Packing labels on the PC package, Monitor
package and Printer package and a label on top of the PC as shown in
Figure 86. Each C-Scan® View is marked with a unique serial number. .. 91
10.6
Essential Performance ...................................................................... 91
10.6.1 C-Scan® Cap ...................................................................... 91
10.6.2 C-Scan® Track ................................................................... 92
10.6.3 C-Scan® View .................................................................... 93
10.7
System Specifications ....................................................................... 93
10.8
Guidance and Manufacturer’s Declaration ............................................ 94
11
Troubleshooting.......................................................................................... 98
11.1
11.2
11.3
11.4
11.5
12
C-Scan® View .................................................................................. 98
Downloading Data from C-Scan® Track ............................................... 98
Printer ............................................................................................ 98
CD/DVD .......................................................................................... 98
C-Scan® Kit..................................................................................... 98
Information for User ................................................................................. 100
12.1
12.2
12.3
12.4
12.5
12.6
Patient and Clinic Information .........................................................
Activities Allowed During the Procedure ............................................
Activities Not Allowed During the Procedure ......................................
Must Do ........................................................................................
Patient Bag Checklist ......................................................................
Keeping Your Patient Diary..............................................................
DOC000300 / C-SCAN User Reference Manual
100
100
100
101
101
101
12.7
Using the Stool Collection Device .....................................................
12.7.1 Attaching the Stool Collection Device Container ....................
12.8
Retrieving the Capsule at the End of the Procedure ............................
12.9
In Case of Malfunction ....................................................................
12.10 When to Call the Clinic ...................................................................
12.11 Guidelines for the Clinic ..................................................................
102
103
104
104
104
104
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1: C-Scan® System Key Components ................................................. 16
2: C-Scan® Cap ............................................................................... 16
3: C-Scan® Track ............................................................................. 18
4: PC Package – with Accessory Package ............................................. 20
5: PC Package – with Accessory Package Removed ............................... 20
6: Accessory Package ........................................................................ 21
7: PC Connection to Power 1 .............................................................. 21
8: PC Connection to Power 2 .............................................................. 21
9: Mouse ......................................................................................... 22
10: USB Ports ................................................................................... 22
11: Monitor Unpacking Instructions 1 .................................................. 23
12: Monitor Unpacking Instructions 2 .................................................. 23
13: DVI Cable ................................................................................... 23
14: Monitor Power Cable .................................................................... 24
15: Monitor Connections .................................................................... 24
16: Monitor DVI Connection to PC ....................................................... 25
17: Printer ....................................................................................... 26
18: Printer (cont.) ............................................................................. 27
19: Printer Connection ....................................................................... 27
20: Power-on Button ......................................................................... 27
21: Welcome Screen ......................................................................... 28
22: User Settings .............................................................................. 29
23: C-Scan® Kit ............................................................................... 35
24: Activating the C-Scan Track ......................................................... 35
25: Placing the Location Template ....................................................... 37
26: Affixing the Stickers .................................................................... 38
27: Attaching the C-Scan® Track to the Patient’s Back .......................... 39
28: Patient Taking the Capsule ........................................................... 40
29: Placing Capsule in Sealable Plastic Bag .......................................... 42
30: C-Scan® View Welcome Screen .................................................... 44
31: Shutdown ................................................................................... 45
32: Connecting the C-Scan® Track to the C-Scan® View....................... 45
33: C-Scan® Track Failure to Connect Error Message ............................ 46
34: Procedure Details Window ............................................................ 46
35: Patient Details Window ................................................................ 47
36: Patient Details Cancel Message ..................................................... 47
37: Processing Data Screen ................................................................ 48
38: Cancel Message .......................................................................... 48
39: Load CD Progress Screen ............................................................. 49
40: Load CD Failure Screen ................................................................ 49
41: Procedure Details Screen ............................................................. 50
42: User Settings .............................................................................. 51
43: Change Date and Time................................................................. 51
44: Navigation Bar ............................................................................ 52
45: Review Screens-General .............................................................. 53
46: Mode Selection ........................................................................... 59
47: 3D View Selection ....................................................................... 59
48: Segment Control Bar ................................................................... 60
49: Slice Control Bar ......................................................................... 60
DOC000300 / C-SCAN User Reference Manual
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Segment Timeline ....................................................................... 60
CMT and XRF Maps: No Suspect .................................................... 61
Region of Interest (ROI)............................................................... 61
Colon Segment with Suspicious Finding .......................................... 62
Capsule Position Graph ................................................................ 63
Track Sensors Graph ................................................................... 64
Capsule Orientation Graph............................................................ 64
Capsule Environment Graph ......................................................... 65
Capsule Position in Colon ............................................................. 65
Suspect Analysis Wizard ............................................................... 66
Suspect Visibility ......................................................................... 67
Help Text and Diagrams for Suspect Visibility ................................. 67
Example of Good Visibility on Both Maps ........................................ 67
Example of a Poor Visibility on One Map (CMT) ............................... 68
Example for Suspect Visible on One Map Only (XRF) ........................ 68
Suspect Quality ........................................................................... 68
Help Text for Suspect Quality........................................................ 68
Asymmetrical Protruding in 3D View .............................................. 70
Help Text for Asymmetrical Protruding ........................................... 70
Local Orientation ......................................................................... 71
Pressure Events .......................................................................... 73
Colon Model Location ................................................................... 75
Help Text for Suspect Location ...................................................... 76
Clinical Opinion ........................................................................... 76
Suspect Analysis Result................................................................ 77
Results Tab ................................................................................ 78
C-Scan® View Report Screen ....................................................... 80
Patient Field ............................................................................... 80
Procedure Field ........................................................................... 80
Screen Capture Field ................................................................... 81
Physician Comment Fields ............................................................ 81
Generate CD Progress .................................................................. 82
Generate CD Cancel .................................................................... 82
C-Scan® Report – 4 Structured Pages ........................................... 82
C-Scan® Kit Labels ..................................................................... 90
C-Scan® Cap Label ..................................................................... 90
C-Scan® Track Labels ................................................................. 91
C-Scan® View Labels .................................................................. 91
Using the Stool Collection Device – Lay on Top of the Toilet Seat .... 103
Using the Stool Collection Device and Accessories ......................... 103
End of Procedure Flow Chart
Tables
Table 1: Graphics Main Displays and Functionalities ........................................ 53
Table 2: Suspect Quality Examples ............................................................... 69
Table 3: 3D Examples ................................................................................. 70
Table 4: Capsule Orientation Examples.......................................................... 72
Table 5: Pressure Event Examples ................................................................ 73
Table 6: Images with Artifacts ...................................................................... 79
Table 7: Technical Specifications .................................................................. 93
Table 8: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions . 94
Table 9: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity . 95
Table 10: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 96
Table 11: Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the C-Scan® System ... Error! Bookmark not
defined.
DOC000300 / C-SCAN User Reference Manual
Revision History
Document
Number
Revision
Number
Description
Revision Date
D0C000300
01
Initial release.
TBD
0.92
Draft 2
28 March 2016
0.93
Draft 3
12 April 2016
0.94
Draft 4
9 Aug. 2016
0.978
Draft 4 – IFU, Environ. Specs., Updated
View section, beeps, screws
19 Nov. 2016
01
Manuf. Declaration, Specifications,
Troubleshooting
5 Dec. 2016
02
No CE mark, Instead 'For clinical use only',
no ingestion if pairing fails, View not in
patient's zone, C-Scan® System (no
'imaging')
03 Jan. 2017
03
Check-Cap address updated on front page
2017, Feb 28
04
Updating the range of BMI criteria
2017, Mar 09
05
View work station: updated display and
interpretation flow chart
2017, June 5th
06
Limitation of procedure duration to 100
hours
2017, June 29
07
Clarification on required actions in case of
capsule retention and additional information
for operating the C-Scan View.
2017, Aug. 30
New EU Authorized Representative
Revised disclaimer
08
Add CE mark
2017, Nov. 12
Revision of warnings, indication, risks and
notes, following the response from the NB
09
Activation by a pin in the batteries'
compartment.
Minor revisions of cautions and warnings
2018Jan 31
Updated operation and GUI for the C-Scan
View
10
Additional statements according to FCC
guidelines
DOC000300 / C-SCAN User Reference Manual
2018 July 19
Using This Guide
Using This Guide
1.1
Purpose
This document describes the C-Scan® System. It is intended for Physicians, Nurses
or Clinic Technicians who must manage a C-Scan® procedure. It includes
information about:
 Indications, Contraindications, Warnings, Cautions
 Planning and Performing a C-Scan® Capsule Procedure
 Using C-Scan® View to Create the C-Scan® Reconstructed Colon Display
 Reviewing and Interpreting the
C-Scan® 2D/3D
 Creating a C-Scan® System Report
1.2
Abbreviations, Acronyms, and Definitions
1.3
Definition/Acronym
Description
BIT
Built-In Test
BMI
Body Mass Index
CD
Compact Disc
CMT
Compton Scattering
EV
Expert Viewer
FIT
Fecal Immunochemical Test
IFU
Instructions for Use
mSv
Milli Sievert (X-ray dose units)
RF
Radio Frequency
SCA
Scan Control Algorithm
USB
Universal Serial Bus
XRF
X-ray Fluorescence
Conventions
Note
A note provides clarification, extra information, or refers to
related material.
Caution
A Caution warns about possible damage to equipment.
Warning
A Warning warns about possible harm to person.
Contraindications
Specific situations in which the device and procedure should
not be used because it may be harmful to the person
DOC000300 / C-SCAN User Reference Manual
Indications, Contraindications, Warnings, Cautions
Indications, Contraindications,
Warnings, Cautions
2.1
Intended Use
Check-Cap’s C-Scan® System’s indication for use is as follows:
The C-Scan® System is intended to provide structural information on the
endoluminal surface of the colon. It may be used to screen for suspicious
findings in the colon.
Under this intended use, the C-Scan® System fits into the CRC screening paradigm
as follows:
 A patient with a positive C-Scan® System test would be referred for optical
colonoscopy.
 A patient with a negative C-Scan® System examination would be tracked in the
following years
2.1
Intended Users, Patients and Environments (e.g. home
use, outside)
The screening procedure is indicated for use by trained physician, familiar with all
of the C-Scan® System operating procedures.
The C-Scan system is intended to examine people in the age of 18 years and older
Following the C-Scan® Cap ingestion and attaching of the C-Scan® Track to his
back, the patient precedes with his/hers daily activities.
2.2
Contraindications
This screening procedure is indicated for use by average risk, asymptomatic
population.
Contraindications for the C-Scan® procedure include:
 Not for use in pediatric populations (under 18 years)
 Patients with known or suspected GI related symptoms, complaints, or GI
diseases such as:
 Disorders of swallowing or difficulties with ingesting medications in tablets
or capsules
 Patients, where a concern for aspiration of the capsule exists (for example,
due to cognitive or neurological deficits or a history of aspiration)

 Diffused diseases such as Ulcerative Colitis, Crohn's, or diverticulosis that might
cause bowel strictures (per physician discretion)
DOC000300 / C-SCAN User Reference Manual
Indications, Contraindications, Warnings, Cautions
 Patients with:
 Dysphagia
 IBD
 Chronic constipation
 Known motility disorder
 Mega colon
 Strictures and obstructions in the GI tract
 Fistulas
 Bowel hernia
 Subject with any condition believed to have an increased risk for capsule
retention such as intestinal tumors, radiation enteritis, and incomplete
colonoscopies due to obstructions or NSAID enteropathy, as determined by
physician discretion
 Patients with positive result in FIT (blood in stool)
 Pregnant or nursing women. Women at child bearing age should use
contraceptives during the procedure.
 Patients who underwent lower abdominal surgery in the past that might cause
bowel strictures leading to capsule retention (per physician discretion)
 Patients with known delayed gastric emptying
 Patients with cardiac pacemakers
 Patients with advanced cancer or other life threatening diseases or conditions
 Morbid Obesity (BMI > 40) or very low BMI < 22
 Nuclear imaging procedure or any other medical procedure involved with
radioactive isotopes within the past four (4) weeks
 A patient in course of radiotherapy
 Sensitivity to the Iodine contrast or severe kidney failure
 Patient with any known condition that precludes compliance with device
instructions
2.3
Potential Adverse Events
Use of this device may have potential adverse events:
 Aspiration of the capsule
 Delayed or no excretion of the capsule
 Obstruction, perforation, and mucosal injury or bleeding
Note: There is a low risk of capsule retention, in the GI tract, for more than 300 hours.
In some instances, intervention is required to remove the capsule. Intervention, based on
the physician's decision and imaging of the capsule's location, may include: use of
laxatives, fibers, removal by colonoscopy, or surgery.
2.4
Warnings
There is some risk in any medical examination or procedure. The information
provided here is not replacing the need to consult with physicians regarding the
proper diagnosis and course of treatment.
10
DOC000300 / C-SCAN User Reference Manual
Indications, Contraindications, Warnings, Cautions
The following conditions may present a danger to the patient:
 Results obtained by the C-Scan® System do not exclude the presence of
pathology and if symptoms persist, further evaluation should be performed.
 If the patient has had prior abdominal or pelvic surgery, or if intestinal fistulas,
strictures, or stenoses are suspected, the physician should verify that the
patient GI tract can tolerate an object the size of the C-Scan® Capsule.
 Physician should read the entire manual before using the system for the first
time. A complete understanding of the technical principles, clinical applications,
and risks associated with the C-Scan® System is required before using this
product.
 To keep the patient from being exposed to unforeseen risks during passage of
the C-Scan® Cap, provide the patient with a copy of the Instructions for Use and
make sure the patient thoroughly understands the procedure.
 If there is any doubt about the integrity of the C-Scan® Cap or C-Scan® Track
(C-Scan® Kit), for example, a broken seal on the outer box or on the inner
capsule box, the Kit should be returned to its box and it should not be used until
consulting with an authorized Check-Cap representative.
 The C-Scan® Cap and C-Scan® Track are for single use only.
 Do not use the C-Scan® Cap after its expiration date.
 Do not ingest the C-Scan® Cap if it was accidently dropped on the floor. Consult
with the authorized Check-Cap representative.
 Only one C-Scan® Cap should be ingested at a time and only after confirmation
that no other C-Scan® Cap or ingestible diagnostic devices remain in the
patient’s body.
 Instruct the patient not to bite the C-Scan® Cap prior or during swallowing.
 The C-Scan® Cap should be ingested only after the synchronization test with the
C-Scan® Track has been successfully completed (audible feedback).
 Instruct the patient to contact the physician immediately if, after ingesting the
C-Scan® Cap, there is any abdominal pain, nausea, or vomiting.
 Instruct the patient to wear the C-Scan® Track throughout the procedure.
 Instruct the patient to stay with 2 hours driving distance throughout the
procedure.
 Activities Not Allowed During the Procedure
 Full-body immersion in water
 Active sport
 CT or MRI machines. (Unless it is a medical emergency. Be sure to notify the
medical team about the capsule and Track)
 Do not connect the cable between the C-Scan® Track and the C-Scan® View
while the system is still attached to the patient's back.
 Store the C-Scan® Cap within the Kit box in a safe place, out of the reach of
children and infants before ingesting and after excretion.
 When swallowing the C-Scan® Cap there is the possibility of choking on the
capsule. If the patient exhibits any symptoms and/or clinical signs of choking
(labored breathing, wheezing, involuntary coughing, etc.), the physician
supervising the ingestion should act immediately to alleviate the condition.
 If a child has accidentally swallowed the C-Scan® Cap, seek immediate medical
attention.
DOC000300 / C-SCAN User Reference Manual
11
Indications, Contraindications, Warnings, Cautions
 A C-Scan® Cap should be ingested only in the presence of authorized medical
personnel.
 Patients should carry with them the IFU and adhere to the instructions listed
there.
 Undergoing an MRI while the C-Scan® Cap is inside the patient's body may
result in serious damage to the intestinal tract or abdominal cavity. If the
patient did not positively verify the excretion of the C-Scan® Cap, the physician
should be contacted for evaluation and possible abdominal X-ray before
undergoing an MRI examination.
 The C-Scan® Cap and C-Scan® Track should only be stored in the original
packaging before and after the procedure.
 Final diagnosis based on the C-Scan® View reconstruction should be made only
by GI physicians who are trained in C-Scan® System operation.
 The capsule contains low levels of radioactivity and should therefore be disposed
of according to local codes and regulations. The patients should be instructed
that it should not, under any circumstance, be thrown into the trash.
 If the battery in the Track leaks and one of the ingredients gets into the eyes,
do not rub them. Immediately flush eyes thoroughly with water for at least 15
minutes, lifting upper and lower lids, until no evidence of the chemical remains.
Seek medical attention
 The C-Scan® Track is a delicate electronic device which should be protected from
mechanical damage
Note
In order to avoid conditions that might impair the examinations, the subject
should adhere to the instructions listed in the diary. The clinical team should
verify that all required data is clearly registered in the diary when returned at
the end of the procedure.
2.5
Cautions
The following conditions may damage the equipment or the procedure:
 Only trained personnel, familiar with all of the C-Scan® System operating
procedures should use the system.
 Changes or modifications not expressly approved by the manufacturer could
void the user’s authority to operate the equipment”.
 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..
 Do not immerse the C-Scan® Track in water or seawater. It can be damaged,
 Do not recharge the battery. It is not designed for recharging.
 Do not pierce the battery, or the C-Scan® Track with the battery installed, The
battery may become damaged and deformed,
 Do not use or subject the C-Scan® Track to intense sunlight or hot temperatures
such as in a car in hot weather. Its guaranteed performance will be lost and/or
its service life will be shortened.
 The use of accessories, batteries, and cables other than those supplied or
approved by Check Cap as replacement parts for C-Scan® Track components,
may damage the system and void the warranty.
12
DOC000300 / C-SCAN User Reference Manual
Indications, Contraindications, Warnings, Cautions
 RF communications equipment can affect the C-Scan® Cap and the C-Scan®
Track.
 Use the system only with components purchased from or approved by CheckCap Ltd. Use of other components may damage the system and void the
warranty.
 During installation of the C-Scan® View, be sure to inspect the integrity of the
power cables.
2.6
Benefits and Risks—C-Scan® System
2.6.1
Benefits
The following are advantages of the C-Scan® System as compared to other
modalities:
 No colon preparation
 No diet or food restrictions
 No drugs
 Non-invasive
 No pain or discomfort
 No hospitalization
 No sedation
 Examination while patient continues normal daily routine
 After the patient swallows the C-Scan® Cap, data is transmitted wirelessly as
the capsule passes through the digestive system. The data is captured and
stored in the C-Scan® Track recorder worn by the patient; immediately after the
procedure is complete the data can be downloaded to the C-Scan® View and
reviewed by a physician.
2.6.2
Risks
 The C-Scan® procedure is not for everyone. C-Scan® Cap capsules are
contraindicated in patients with known or suspected gastrointestinal obstruction,
strictures or fistulas, in patients with cardiac pacemakers or other implantable
electro medical devices, and in patients with swallowing disorders.
 There is a low risk of capsule retention, i.e., no excretion of the capsule after
more than 300 hours. In some instances, intervention is required to remove the
capsule. Intervention, based on the physician's decision and imaging of the
capsule's location, may include: use of laxatives, fibers, removal by
colonoscopy, or surgery.
 In patients with unsuspected strictures of the GI tract, the C-Scan® Cap can
potentially cause intestinal obstruction resulting in the need for hospitalization
and surgery.
 There is a low risk from the X-Ray radiation emitted from the capsule. The
typical body dose is ~0.06 mSv (which is of the order of magnitude of the dose
caused by a chest X-ray examination). During the majority of the time that the
capsule is within the patient’s system, radiation is not actively delivered to the
patient. In total, the radiation exposure time (scan time) is up to 40 minutes of
the typical 48-72 hours total transit time in the GI tract from ingestion to
excretion.
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Indications, Contraindications, Warnings, Cautions
 During capsule ingestion, there is a low risk of aspirating the capsule. All
capsule procedures should be ordered by a trained physician, who must be
present during the ingestion to ensure a smooth start to the procedure.
 The stickers placed on the back are made from biocompatible materials. After
removal from the skin, once the test is completed, all marks should disappear
within 24-48 hours. If redness or skin irritation remains after 48 hours, contact
the clinic.
 Patients are instructed to ingest small amounts of iodine-based contrast
material on a daily basis. Patients with kidney failure or sensitivity to iodine
should refrain from the C-Scan® procedure.
 All medical procedures carry some risk. Information in this user manual should
not be used as a substitute for consulting with your physician about diagnosis
and treatment.
2.7
Accuracy of the Imaging Performance
C-Scan®-Cap imaging bench tests indicate the lower visibility limit at 5mm
features. The probability of identifying a 10mm feature while moving at 5mm/sec
is higher than 95%, when requiring visibility level greater than 3 (SNR) at
standard imaging conditions: 30mm colon diameter and 3% Iodine concentration.
These metrics were measured at lab conditions on phantoms.
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Welcome to the C-Scan® System
Welcome to the C-Scan® System
3.1
What is the C-Scan® System?
The C-Scan® System is an innovative, disposable, medical device that enables a
patient friendly, painless, private, and accurate procedure for colorectal cancer
screening. The system is designed to create a reconstructed three-dimensional
image of the interior of the colon to enable detection of clinically significant
suspicious findings with a high degree of sensitivity.
3.2
The C-Scan® System Process
The C-Scan® capsule is ingested by the patient and propelled by natural motility
through the gastrointestinal tract and excreted naturally
The C-Scan® System procedure consists of the following steps:
 Preparing the patient and the system for the ingestion of the capsule
 Performing the capsule procedure
 Data download and 2D/3D images generation
 Review and interpretation by physician
 Preparation of a medical report and recommendation
 Patients should complete the daily diary throughout the procedure. The diary
should be reviewed for completeness by the team in the clinic upon return of
the C-Scan® Kit to the clinic
Note: The movement of the capsule throughout the GI tract is driven by the natural
peristalsis of the bowel. Hence, the total transit time and the dynamics of the capsule
propulsion are unpredictable and may substantially vary between patients.
3.3
C-Scan® System Components
The C-Scan® system is composed of:
 C-Scan® Cap
An ingestible capsule enabling intra-colon feature visualization, based on a
radioactive source and an array of detectors.
 C-Scan® Track
An external Capsule Positioning System (CPS) that communicates with the CScan® Cap, and saves all procedure data. The C-Scan® Track attaches to the
patient's back via adhesive skin patches.
 Algorithms
Uses these subsystems to calculate the C-Scan® Cap position (using
electromagnetic signals generated within the C-Scan® Cap and the C-Scan®
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Welcome to the C-Scan® System
Track), identifies C-Scan® Cap movements in the colon and correspondingly
initiates C-Scan® Cap scans using a dedicated Scan Control Algorithm (SCA).
 C-Scan® View
A PC based Workstation that enables procedure data download from the C-Scan®
Track, managing of patients' information, 2D and 3D colon imaging, report
generation and printout, and storage/reload of procedure data to and from a CD.
A conceptual block-diagram of the system is shown in Figure 1.
Figure 1: C-Scan® System Key Components
C-Scan® Cap
3.4
Figure 2: C-Scan® Cap
The capsule is designed to be ingested without any cleansing of the colon and
travels through the GI tract naturally, while the patient continues eating normally.
The technology is based on a low dose radioactive sealed source embedded in the
capsule, which emits X-rays through a rotating collimator circumferentially. The
capsule’s outer surface incorporates detectors, which are designed to collect the
backscattered photons within the X-ray energy spectrum. To increase the contrast
of the colon’s walls and to differentiate them from its content, it is essential to
increase the stool’s contrast by ingesting regularly a small volume of radio-opaque
material (Telebrix, Omnipaque, or equivalent) during the days of the procedure.
The capsule is designed to start scanning (rotating like helical CT) only when the
capsule is propelled along the colon. While stationary (which is most of the time)
the capsule is set at an idle mode and the radiation is blocked by the concealment
mechanism. The transit time of the capsule in the colon may vary typically from
24-100 hours, depending on the personal bowel activity of the patient. The
capsules are powered by internal batteries and are designed to operate up to 100
hours.
The capsule is excreted naturally and the patient is notified accordingly.
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Welcome to the C-Scan® System
Caution: The C-Scan® Cap capsule transmits data to the C-Scan® Track at a specific
frequency of 433.5 MHz ±127 KHz. Occasionally, interference from external
devices transmitting in the same bandwidth may occur and consequently
interrupt or limit the effective performance of the 2-way C-Scan® Cap - C-Scan®
Track transmission.
Following are possible scenarios:
 Cellular telephones
 Car or house alarm: These systems operate with momentary transmissions.
Depending on the proximity of the car or house alarm transmitter to the
ingested capsule, there may be a momentary interference that is not likely to
damage the data capture.
 Police/Fire station radio equipment: These systems may operate with a more
extended transmission duration. Depending on the proximity of the car or house
alarm transmitter to the ingested capsule, this may cause longer duration
interference, possibly causing gaps in the data.
3.5
Handling the C-Scan® Cap
The C-Scan® Kit package is designed to ensure a 7cm radiation safety distance
from the X-ray source. The capsule should remain in its sealed box in the C-Scan®
Kit box until ingestion by the patient. This renders it safe for handling, with no
special equipment or precautions necessary.
Since the collimator and concealment mechanism are in the idle state when the
capsule is removed from the packaging, it remains safe to handle. Once ingested
by the patient, the collimator switches to active (open) mode only when the
system senses effective movement in the bowel. The typical calculated radiation
effective dose of the C-Scan® Cap in active mode during the procedure is 0.06
mSv (calculated for a procedure of 72 hours with 30 min of active scanning).
To avoid accidental activation of the capsule while in its box, please observe the
following:
 Keep the C-Scan® Cap in its box until use.
 Store the C-Scan® Cap only in the packaging supplied with the product.
 Do not use a C-Scan® Cap if the packaging is damaged.
 Keep the C-Scan® Cap package away from strong magnetic fields (such as MRI
devices).
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Welcome to the C-Scan® System
C-Scan® Track
3.6
For full directions on using the C-Scan® Track, see Chapter 5: Planning and
Performing a C-Scan® Capsule Procedure.
Figure 3: C-Scan® Track
The C-Scan® Track is an external device that tracks the C-Scan® Cap position,
sends commands to the C-Scan® Cap, receives and stores imaging data sent by
the C-Scan® Cap, and interfaces at the end of the procedure with the C-Scan®
View.
The C-Scan® Track is a miniaturized and advanced subsystem consisting of the
following units:
 C-Scan® Cap Positioning System - a localization device aimed to track and
record the position and orientation of the C-Scan® Cap, enabling intra-colon
mapping for the purpose of colon surface imaging
 Data Recorder - a computerized recording device aimed to capture C-Scan®
Cap’s data (imaging, etc.), through RF communication during its transition in
the GI tract to a non-volatile memory, and enable data retrieval through a
communication line following procedure completion.
 Processing Unit – an embedded device aimed to control localization and
recording functions while running an embedded Scan Control Algorithm through
which the C-Scan® Cap’s scan mechanism is operated.
 User Interface Unit – Status indicators
 USB Interface Unit – Data retrieval from C-Scan® Track, for the purpose of
clinical data upload to C-Scan® View, production testing, and serviceability.
The C-Scan® Track attaches to the patient’s lower back.
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3.7
C-Scan® View
The C-Scan® View is a dedicated PC-based workstation that imports procedure
data from the C-Scan® Track, manages patient information, displays the 2D and
3D colon imaging, and generates a procedure report and a results CD.
The C-Scan® View main functions are:
 Load and display procedure information and data
 Images Review - enables the user to view the "colon" 2D/3D reconstruction
 Produce procedure's review report
 Store and view procedure results on a CD
Note: In the current system configuration, the C-Scan® View is not connected to the
Hospital Information System nor to the internet. There is no transfer of patient data or
demographics to or from the C-Scan® View.
The user (nurse/technician/physician) would use the C-Scan® View as follows:
 Log in to the C-Scan® View
 Connect the C-Scan® Track to the C-Scan® View using the supplied USB cable
 Start a new procedure:
 Enter procedure's information, according to clinic/hospital records. Once a
procedure is created, C-Scan® View processing is carried out automatically,
including data loading, parsing (raw data processing), and reconstruction.
 View the results in the graphics window
 Review and search for clinical findings that need further intervention
 Create a summary report and print it
 Create a procedure results CD, which can be later loaded and viewed in any
Check-Cap C-Scan® View
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C-Scan® View Installation Guide
C-Scan® View Installation Guide
Note: System operation requires a dedicated space with:
 a table (at least 160cm X 70cm)
 a chair
 3 power connections, compatible for use in the US or Europe
 Be sure to locate the C-Scan® View outside the patient zone (ingestion room)
The following instructions describe how to install the C-Scan® View PC sub-system.
Open the PC package and remove the Accessory Package, which contains the
keyboard, mouse, and cables. See Figure 4 and Figure 5.
Figure 4: PC Package – with Accessory Package
Figure 5: PC Package – with Accessory Package Removed
Remove the PC from the package.
Remove the power cable from the Accessory Package and connect it to the PC. See
Figure 6, Figure 7: , and Figure 8: .
Connect the other end of the power cable to the power outlet.
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C-Scan® View Installation Guide
Figure 6: Accessory Package
Figure 7: PC Connection to Power 1
Figure 8: PC Connection to Power 2
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C-Scan® View Installation Guide
Remove the mouse from the Accessory Package.
Figure 9: Mouse
Connect the mouse to any of the USB ports on the rear of the PC, as shown in
Figure 10.
Figure 10: USB Ports
Remove the keyboard from the Accessory Package.
Connect the keyboard to any of the USB ports on the rear of the PC, as shown in
Figure 10.
Prepare the monitor for operation, according to the monitor user manual provided
in the monitor package.
Open the monitor package.
Remove the monitor from the package, as shown in Figure 11 and Figure 12.
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C-Scan® View Installation Guide
Figure 11: Monitor Unpacking Instructions 1
Figure 12: Monitor Unpacking Instructions 2
Remove the DVI cable and the monitor power cable from the Accessory Package,
as shown in Figure 13 and Figure 14.
Figure 13: DVI Cable
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C-Scan® View Installation Guide
Figure 14: Monitor Power Cable
Connect the DVI cable to the DVI connector on the monitor and to the DVI
connector on the PC.
Connect the monitor power cable to the power connector on the monitor and to
the power outlet. See Figure 15 and Figure 16.
Figure 15: Monitor Connections
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C-Scan® View Installation Guide
Figure 16: Monitor DVI Connection to PC
Prepare the printer for operation according to the printer user manual provided in
the printer package.
Connect the printer power cable to the printer power connector and then to the
power outlet.
Press the start button to turn on the printer.
Open the printer cover as shown in Figure 17 and insert the ink cartridges in the
proper order. Close the printer cover.
Add paper as shown in Figure 18.
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C-Scan® View Installation Guide
Figure 17: Printer
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C-Scan® View Installation Guide
Figure 18: Printer (cont.)
Connect the printer USB cable to the USB port on the printer (see Figure 19) and
to any of the USB ports on the rear of the PC.
Figure 19: Printer Connection
Turn on the PC by pressing the power button (see Figure 20). Make sure printer
and screen are on.
Figure 20: Power-on Button
Note: The work station is intended to be operated in an office setting similar to standard
PC operation:
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C-Scan® View Installation Guide
 Office desk - height 70-75 cm
 PC display - at eye level
 Keyboard & Mouse – on table top
 Printer - easily accessible by operator
 Annual maintenance needs to be performed in order to clean the hard drive and
replace USB cable once every year
Figure 21: Fully Installed System
Upon system boot, the Welcome screen is displayed.
Figure 21: Welcome Screen
Click User Settings on the Welcome screen to open the User Settings window.
The User Settings dialog opens, as seen in Figure 22. Edit the clinic name, time
zone, date, and time, for use within the C-Scan® View application, with the User
Settings dialog.
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C-Scan® View Installation Guide
Figure 22: User Settings
Edit the Clinic Name.
Change the date and time (click the Date & Time Picker icon). The Windows Date
and Time window opens.
Click Save to save all changes and to return to the Welcome screen. Click Cancel
to discard the changes and to return to the Welcome screen.
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Planning and Performing a C-Scan® Capsule Procedure
Planning and Performing a C-Scan®
Capsule Procedure
This section describes the steps for planning and performing a capsule procedure
using the C-Scan® System. It includes the following information:
 Physician’s Preliminary Meeting with the Patient
 Day of Procedure Meeting with the Patient
 Ingesting the Capsule

 Review with the patient the content of the Bag and related documents.
Discharge the patient.
 During the Procedure
 End of Procedure
 Post-procedure
Note: This document uses the terms physician and nurse or technician to identify the
various tasks performed during a C-Scan® procedure. Tasks marked for Physician must
be performed by a physician trained by Check-Cap. Tasks marked for Technician may be
performed by a nurse, technician, physician’s assistant, or by the physician, depending on
the particular clinic’s protocol.
Physician’s Preliminary Meeting with the Patient
5.1
Before scheduling a C-Scan® procedure and ordering the C-Scan® System, the
physician should determine if the patient is a candidate for the procedure. The CScan® System is intended to provide structural information on colonic suspicious
findings, lesions and masses.
The Check-Cap C-Scan® System is indicated for providing structural information
on colonic suspicious findings, lesions and masses.
Under this indication for use, the C-Scan® System would fit into the CRC screening
paradigm as follows:
 A patient with a positive C-Scan® System test would be referred for optical
colonoscopy
 A patient with a negative C-Scan® System examination would be followed in the
coming years as per the current standard of care in patients following CT
Colonography
Importantly, imaging with the C-Scan® System is performed without bowel
preparation, use of sedatives and/or anesthesia, or an invasive procedure with its
associated risks and, all considerations when a patient is referred for optical
colonoscopy.
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5.1.1
Guidelines for Determining Patient Suitability for the C-Scan®
Procedure
This procedure is indicated for use by average risk asymptomatic population.
These guidelines are designed to assist the physician in deciding whether to
proceed with the C-Scan® procedure for any patient.
Note: The physician is ultimately responsible for making this decision. It should be made
in accordance with these guidelines, clinic policy, and good medical practice.
To determine whether the patient should undergo the capsule procedure with the
C-Scan® System, verify that no contraindications apply to the patient:
 The C-Scan® System is not for use in pediatric populations.
 The C-Scan® System is designed for use with subject’s age of 18 and older.
 Patients with any known GI related symptoms complaints or GI diseases should
not undergo this procedure. Symptoms may include (this list is not
comprehensive and the physician should use his/her own judgement):
 Chronic gastrointestinal bleeding
 Diarrhea that does not resolve
 Known or suspected intestinal obstruction, strictures or fistulas
 Diffused diseases such as Ulcerative Colitis, Crone's, or diverticulosis
 Swallowing disorders or difficulty ingesting medications in tablets or capsules
 GI surgery within the past three (3) months
 Bowel hernia
 Abdominal surgery that might have caused bowel adhesions and strictures
(physicians' decision)
 The C-Scan® System should not be administered to a patient with the following
medical conditions:
 A patient who underwent a nuclear imaging procedure or any other medical
procedure involved with radioactive isotopes within the past four (4) weeks
 A patient in a course of radiotherapy
 A patient who uses an implanted or portable electro-mechanical device
 Patients with cancer or other life threatening diseases or conditions
 Pregnant women (to be verified by test in case of doubt)
 Morbid Obesity (BMI > 40) or BMI < 22
 Drug abuse or alcoholism
 Patient's bowel movements are irregular: less than 2 -3 bowel movements
/week
 Patients with known cardiovascular and pulmonary diseases that limit their
daily activities or are classified as life threatening
 Patients who work in an area with a high electromagnetic field should not be
examined by the capsule.
 Patients allergic to the contrast agent. Contact Check-Cap for possible substitute
contrast agents.
5.1.2
Planning the Procedure with the Patient
The physician should discuss all aspects of the procedure with the patient,
including:
 Providing instructions to the patient regarding the preparations prior to
ingestion.
Note: This information is also provided to the patient in the Patient Log, which includes
tracking of the bowel movement 5-7 days prior to ingestions.
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Planning and Performing a C-Scan® Capsule Procedure
 Discussing with the patient how to prepare for the procedure:
 Skip breakfast on the morning of the procedure so that the stomach is empty.
Coffee or tea or juice is permitted.
 Take all medications as normal
 Consult with the patient regarding the potential impact of concomitant routine
drugs
 Wear a loose fitting shirt. Women should not wear a dress, as the back must
be exposed to attach the C-Scan® Track.
 Familiarize the patient with all allowed activities, as indicated in
Section 5.2.1.1 Activities Allowed by Patient.
 Plan the daily activities during the procedure, avoiding those activities
indicated in Section 5.2.1.2 Activities to be avoided by Patient
 Set the day and time for ingestion
 Verify that all accessories are in stock. See Chapter 12: Information for User for
a list of accessories.
5.1.3
Order the C-Scan® System
See Chapter 9: Ordering the C-Scan® System for directions.
5.2
Day of Procedure Meeting with the Patient
5.2.1
Physician’s Pre-procedure Meeting
On the day of the procedure, before administering the C-Scan® Cap capsule, the
physician should discuss the examination with the patient, obtain the patient’s
approval, and have the patient sign the clinic’s Informed Consent Form [ICF], (For
clinical study only, not required for normal use of the device).
Prepare all the accessories and consumables in the patient's bag
Review all the steps involved in the procedure:
 Attaching the C-Scan® Track (described in Section 5.2.2: Preparing the Patient
for the Procedure)
 Instruct the patient what to expect before, during, and after the procedure.
 If the patient experiences any abdominal pain, nausea, or vomiting after
ingesting the C-Scan® Cap capsule, the patient should immediately inform the
medical staff.
 If, within 4 days after capsule ingestion the capsule is not excreted, the
patient should contact the physician.
 If, within 2 days after capsule excretion, the patient experiences any postprocedure abdominal pain, vomiting, or other unexplained symptoms, the
patient should contact the physician for evaluation.
 Instruct the patient if one of the adhesive stickers detaches from the patient's
body to clean and dry the area and affix a new sticker from the C-Scan® Kit.
 Instruct the patient if the C-Scan® Track detaches from its sticker to reattach it
to the sticker. The C-Scan® Track will restart recording once it is reattached.
5.2.1.1
Activities Allowed by Patient
The following activities are allowed before and during the procedure:
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 Eating normally before and after ingesting the capsule, except for skipping
breakfast on the first day of the procedure.
 Continuing the daily routine: work, sleep, driving/riding in car or use of public
transportation, sit, stand, walk
 Taking a shower (leaving the Recorder attached to the back)
5.2.1.2
Activities to be avoided by Patient
After ingesting the capsule and until its excretion the patient should avoid the
following activities:
 Taking a bath, swimming, or hot tab (Jacuzzi)
 Active sport such as jogging, physical exercise in the gym, sauna, any ballgames, skiing, bicycle ride etc.
 Flights, boat trips, or long train travels
 CT or MRI procedures (unless it is an emergency, then be sure to notify the
medical team about the capsule and Track).
5.2.1.3
Actions required to be taken by Patient
The patient must take the following actions through the entire procedure:
 Comply with the instructions given by the physician regarding the consumption
of contrast material, fibers, or other food supplements.
 Ingest the contrast agent periodically as indicated. The contrast medium used in
this procedure is water soluble Iodine (such as Telebrix or Omnipaque).
 Read the IFU before the ingestion and during the procedure. Keep it with you
until the end of the procedure
 Keep the C-Scan® Track attached to the body at all times.
 Consult with the clinic with any medical or operational question or concern.
 Adhere to the limitations on activities as listed in Section 5.2.1.2 Activities to be
avoided by Patient (and detailed in the IFU).
 Respond to the 'end of procedure' indication from the system by collecting the
capsule from the stool and removing the C-Scan® Track from the back and
placing it in the designated container.
 Return the C-Scan® Track to the clinic as early as possible.
 Be sure to collect and return all unused supplies
 Notify the clinic if no 'end of procedure' indication was received after 100 hours
(4 days) post ingestion.
 Notify the clinic immediately if an error message was received from the C-Scan®
Track.
Note: The capsule will send a special signal in case of a concealment malfunction (high
radiation) in order to notify the patient and medical team.
 Notice bowel habits. Consult the clinic in case of major changes (constipation or
diarrhea).
 Patient should call the clinic if there are any questions or doubts.
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Planning and Performing a C-Scan® Capsule Procedure
5.2.2
Preparing the Patient for the Procedure
Warning: All medical staff (technicians, nurses, physicians) administering the C-Scan®
System must complete a basic training by Check-Cap before performing a procedure.
5.2.2.1
Verify that the Equipment is Available (Technician)
Before the patient arrives for the procedure, verify that the following equipment
and accessories are available:
 C-Scan® Kit (as supplied by Check-Cap on a per patient basis), that contains:
 C-Scan® Cap capsule (in a sealed box)
 C-Scan® Track recorder with two AA Batteries installed
 C-Scan® Track stickers (package of six)
 C-Scan® Instructions for Use (IFU)
 Patient Diary
 A tool for tightening the screws
 C-Scan® Track Location Template (supplied by Check-Cap)
 The following items are purchased locally by the clinic and stocked for numerous
procedures:
 Water and drinking cup
 Patient Bag with consumables (purchased by the clinic, according to CheckCap recommendation):
o Fiber Supplement
o Contrast Agent
o Stool Collection Device (5-7 units)
o FIT Kit (For clinical study only, not required for normal use of the
device)
o Gloves
o Plastic Tongs
o Sealable Plastic Bags
o Alcohol Wipes
Verify that the patient’s informed consent is on file.
5.2.2.2
Physician’s Procedure Meeting
1. Review the IFU with patient and repeat the highlights.
C-Scan® System:
Instructions for Use (IFU)
Explain to the patient how to use the contrast material and the fiber supplement.
One portion of each should be taken three times a day – morning, noon, and
evening. They do not have to be taken in conjunction with meals.
Explain to the patient to continue to take all medications as normal.
Explain to the patient how to retrieve the capsule upon excretion. The patient
should use a Stool Collection Device to collect each bowel movement. Even in
cases that the C-Scan® Track does not indicate capsule excretion, the feces should
be sifted for the capsule before dumping it in the toilet and flushing. Use the
instructions in the kit for exact directions as to its use.
If the C-Scan® Track indicates that the C-Scan® Cap has been excreted, use
the gloves and plastic tongs to retrieve the capsule. Clean the capsule under
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running water and place in the sealable plastic bag. Replace the bag and
capsule in the C-Scan® Kit box and return it to the clinic.
Explain to the patient how to make entries in the Patient Diary.
5.2.2.3
Preparing the C-Scan® System for the Procedure (Technician)
1. Open the C-Scan® Kit cover. Verify that the seal is still intact. If the box has
been opened, discontinue the procedure and contact Check-Cap for further
directions.
Caution: Do not remove any components from the package at this time.
Figure 23: C-Scan® Kit
Take out the IFU and hand it to the patient.
Pull out the pin from the cover of the batteries' compartment to activate the Track.
A beep is heard within 1 minute and the green LEDs will start blinking.
Figure 24: Activating the C-Scan Track
This activation initiates pairing of the capsule and the recorder. Pairing is
performed before the C-Scan® Cap ingestion, and includes tuning of the CScan® Track to the specific C-Scan® Cap.
Once paired, the recorder will work only with this capsule. The system tests
the communication between the capsule and the recorder and indicates
success with an audible beep. A sequence of 5 repeated short beeps and
blinking green lights on the C-Scan® Track.
If pairing fails, it is indicated by a longer series of Beeps (5 sec.). Please
contact Check-Cap for possible actions. The physician should not allow the
patient to ingest the capsule following 'pairing fails' notification
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Planning and Performing a C-Scan® Capsule Procedure
Remove the C-Scan® Track and stickers from the C-Scan® Kit box. To attach the
Recorder to the patient, you will need the following equipment:
 C-Scan® Track
 C-Scan® Track Location Template
 C-Scan® Track stickers
 Razor and alcohol (not supplied), to shave the area of the sensors on the back
Note: The C-Scan® Track stickers must be applied directly to smooth skin for proper
adhesion. Make sure there are no obstructions, such as hair. If needed, shave the area
where the C-Scan® Track is to be attached.
36
Remove overcoat, jacket, etc.
Open the belt buckle and button of the trousers. Slightly lower the
trousers.
Pull up the shirt and expose the lower back.
Place the C-Scan® Track Location Template on the patient’s back and use
a marker to mark the area where the C-Scan® Track should be attached.

Keep the center mark on the vertebra line.

Place the lower mark just above the bottom over the tailbone.
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Planning and Performing a C-Scan® Capsule Procedure
Figure 25: Placing the Location Template
Remove the template.
Note: There are two size stickers. The smaller ones are used to affix the two top
individual sensors, and the larger one to affix the bottom sensor/recorder unit.
Have the patient slightly bend forward at a 45 degree angle. This helps ensure a
strong adhesion during patient motion. Clean the area with alcohol. Remove the
backing from a sticker and affix it to the patient’s skin just above the buttocks
according to the mark previously made. Repeat the same for the remaining two
upper stickers.
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Planning and Performing a C-Scan® Capsule Procedure
Figure 26: Affixing the Stickers
Attach the lower recorder unit to the lower patch by pressing the unit so that the
hook and loop fasteners engage.
Attach the two upper units, left and right to the upper patches, press firmly to
assure optimal fit.
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Figure 27: Attaching the C-Scan® Track to the Patient’s Back
Note the patient and procedure details in the clinic log for capsule procedures and
in the patient's diary.
Let the patient get dressed and make sure that the patient is comfortable.
Ensure there are no alarms from the C-Scan® Track recorders attached to the
back.
Verify that the patient has the contact details in case of queries or any
malfunction.
5.3
Ingesting the Capsule
Fill a cup with contrast agent diluted with water and place it next to the patient.
Hand the C-Scan® Cap sealed box to the patient. Verify that the seal is still intact.
The patient should open the box by removing the “Remove before ingestion” label
on the side of the box. Note: If the box has been opened, discontinue the
procedure and contact Check-Cap for further directions.
The patient must open the box by releasing the blue clasp downward (preferably
above a table) and remove the capsule. Make sure the patient does not squeeze
the capsule.
Be sure to keep the box above a table or similar work top, to prevent accidentally
dropping the capsule on the floor. If it falls – it must not be ingested
Explain to the patient that the capsule must not be bitten or held between the
teeth, but rather it must be placed on the tongue until it is ingested.
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Planning and Performing a C-Scan® Capsule Procedure
Figure 28: Patient Taking the Capsule
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Have the patient swallow the capsule with some water (with contrast agent) and
witness the smooth ingestion of the capsule.
Ask the patient to wait 5-10 minutes before leaving.
Verify that there have been no malfunction alarms from the C-Scan® Track.
Remember that there is no indication of normal operation, except for the absence
of alarms.
Hand the patient the Patient Bag and the empty C-Scan® Kit box.
Review with the patient the content of the Bag and related documents.
Discharge the patient.
5.4
During the Procedure
The patient should do the following during the procedure:
 Take the contrast agent and the fiber supplement as directed. Record each
intake in the patient log.
 List all meals in the patient log.
 List all bowel movements in the patient log. Use a Stool Collection Device with
each bowel movement. Use the instructions in the kit for exact directions as to
its use.
 Carry a Stool Collection Device with you when you leave the house (to work
etc.). Be sure to take the Kit box with you to store the retrieved capsule in it.
The clinic team (technician and/or physician) should contact the patient every 1-2
days to ensure adherence to procedure instructions. Enter each contact into clinic’s
patient record.
Note: The clinic team (technician and/or physician) should contact the patient ~100
hours after ingestion, in case the capsule has not been excreted and collected already.
They should discuss with the patient the possibility of lost capsule (in the toilet) and
consider inviting the patient to the clinic for abdominal X-Ray to assure it is already out of
the body. In some instances, intervention is required to remove the capsule.
Intervention, based on the physician's decision and imaging of the capsule's location, may
include: use of laxatives, fibers, removal by colonoscopy, or by surgery.
5.5
End of Procedure
The procedure concludes upon excretion of the C-Scan® Cap. When the capsule is
excreted, the C-Scan® Track indicates the end of the procedure with a series of 4
short beeps.
When the C-Scan® Track indicates that the C-Scan® Cap has been excreted, use
the gloves and plastic tongs to retrieve the capsule. Clean the capsule under
running water and place in the sealable plastic bag. Replace the bag and capsule
in the C-Scan® Kit box and return it to the clinic.
Note : If the Kit box is not with you, be sure to warp the capsule with any soft padding to
protect the delicate medical device and place the bag with the capsule in an
alternative container of the same size as the Kit box.
Keep the container away from the body. Do not put the capsule in your pockets.
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Planning and Performing a C-Scan® Capsule Procedure
Figure 29: Placing Capsule in Sealable Plastic Bag
Record the end of the procedure in the Patient Log.
5.6
Post-procedure
5.6.1
Patient Post-procedure Actions
1. Place the retrieved C-Scan® Cap capsule in the sealable plastic bag, seal the
bag, put it in the capsule box and then in the capsule box holder in the
Procedure Box.
Remove the C-Scan® Track from the stickers.
Replace the C-Scan® Track in the original C-Scan® Kit box. Do not remove the
batteries.
Remove the stickers from the back and discard them.
Place the completed Patient Diary in the Patient Bag.
Replace all unused vials of contrast agent and fibers in the Patient Bag.
Return the C-Scan® Kit and the Patient Bag to the clinic (in person or by
messenger).
5.6.2
Technician Post-procedure Actions
1. Receive the C-Scan® Kit and Patient Bag from the patient.
Remove the C-Scan® Track from the box, verify the ID number and procedure
details.
Leave the C-Scan® Cap in the box. It will be disposed of later, together with the CScan® Track, according to local codes & guidelines. See Section 9.2: Returning
the C-Scan® Cap for instruction.
Review the completed patient diary and verify patient adherence to the
instructions. Pay special attention to the notes on the contrast material.
Connect the C-Scan® Track to the C-Scan® View workstation for data download,
using the supplied USB cable. (See Chapter 6 for directions on creating the CScan® reconstructed 3D display).
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Note: The download and reconstruction process is typically completed in 60 minutes or
less.
Verify that the C-Scan® Cap is in the C-Scan® Kit box.
5.6.3
Physician Post-procedure Actions
2. Review the patient clinical data in all optional modes of presentation. See
chapter 7 for a complete description of using the C-Scan® View program.
Search for clinical findings, add annotations and interpretation.
Prepare a clinical report.
Note: Review of the reconstructed images and interpretations should typically be
completed in 10-15 minutes (by trained physicians).
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Using C-Scan® View to Create the C-Scan® Reconstructed Colon Display
Using C-Scan® View to Create the
C-Scan® Reconstructed Colon
Display
C-Scan® View is a proprietary application that reconstructs the raw data from the
C-Scan® Track to a viewable format for review and analysis by the physician. It is
installed by Check-Cap on a PC supplied by Check-Cap.
Caution: The C-Scan® View workstation is designed to be used only with the C-Scan®
System. Connecting any other devices or peripherals not defined in this
document can cause it to malfunction.
C-Scan® View imports procedure data from the C-Scan® Track, displays the 2D/3D
colon reconstruction, and generates a procedure report and a results CD.
The C-Scan® View is comprised of the following components:
 PC with CD R/W drive and USB port
 Monitor, Keyboard, Mouse
 Printer
Upon system boot, the Welcome screen is displayed:
Figure 30: C-Scan® View Welcome Screen
The user can:
 Load data from a C-Scan® Track
 Review a previous procedure saved on a CD
 Change settings
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 Click the X to close the Welcome screen. This opens the Shutdown button.
Click Shutdown to shut down the PC.
Figure 31: Shutdown
6.1
C-Scan® Track Download
To download the procedure data into the C-Scan® View and start a new procedure
analysis session, connect a C-Scan® Track (only one) to the C-Scan® View using
the included USB cable, and click Load C-Scan® Track on the Welcome screen.
Figure 32: Connecting the C-Scan® Track to the C-Scan® View
Once a C-Scan® Track is connected and Load C-Scan® Track is clicked, the CScan® View starts a new procedure process.
If Load C-Scan® Track is clicked and the download fails for any reason, the CScan® View displays the following notification: “Failed to connect to C-Scan®
Track. Please check C-Scan® Track connection”. Check the C-Scan® Track
connection to the PC and click OK to close the message and return to the Welcome
screen.
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Using C-Scan® View to Create the C-Scan® Reconstructed Colon Display
Figure 33: C-Scan® Track Failure to Connect Error Message
Loading and Processing C-Scan® Track Data
6.2
After successfully connecting a C-Scan® Track and clicking Load C-Scan® Track,
the Procedure Details window opens.
Figure 34: Procedure Details Window
Verify that the C-Scan® Cap Serial Number and the C-Scan® Track Serial Number
match those actually used. Click Confirm to open the Patient Details window.
If the information on the screen is incorrect, click Cancel to close the window and
return to the Welcome screen. Connect the C-Scan® Track with the correct serial
number to the C-Scan® View and continue the download.
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Figure 35: Patient Details Window
Enter the patient details:
 Enter the Family Name (maximum of 20 characters).
 Enter the First Name (maximum of 20 characters).
 Assign an ID (e.g., patient ID or birthdate), or copy the ID from the
Clinic/Hospital record for cross-reference purposes (maximum of 20 characters).
 Enter any remarks (maximum of 1000 characters).
To save the patient data, click Next. The Processing Data screen opens and shows
the progress of the download and reconstruction.
Press Cancel to close the window and return to the Welcome screen. A
confirmation message opens:
Figure 36: Patient Details Cancel Message
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Figure 37: Processing Data Screen
Upon successful completion, all three stages show a check-mark. Click Finish to
complete the processing and begin reviewing the 3D Reconstruction.
If a stage failed, a red X appears next to the failed action and the notification
“Invalid data” is displayed. Click Cancel to cancel the processing and return to the
Welcome screen. A confirmation message opens:
Figure 38: Cancel Message
Press Exit Session to close the window and return to the Welcome screen. Press
Continue to continue the session and advance to the Processing Data window.
6.3
Viewing a 3D Reconstruction from a CD
Place a CD that contains patient procedure analysis results in the CD drive and
close the drive. Click View CD on the Welcome screen to load the procedure from
the CD. The system reads the information and displays the CD Load Progress
screen.
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Figure 39: Load CD Progress Screen
If the CD fails to load, an error message is displayed:
Figure 40: Load CD Failure Screen
Click Close to return to the Welcome screen.
When the CD completes loading, the system displays the Procedure Details screen.
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Using C-Scan® View to Create the C-Scan® Reconstructed Colon Display
Figure 41: Procedure Details Screen
The Procedure Details screen displays the following items:
 Patient full name
 Patient ID
 C-Scan® Track Serial Number
 Clinic name
 CD Creation Date
Click Confirm to advance to the Review screen. See Chapter 7 for information on
reviewing a 3D Reconstruction.
6.4
Backing Up Data
The user can create a procedure results CD, enabling reviewing the results at
another time or on another C-Scan® View. The Report can be viewed on any PC,
except for the C-Scan® View, that supports reading PDF files.
See Section 6.4 for directions for saving procedure results.
6.5
User Settings
Click User Settings on the Welcome screen to open the User Settings window.
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Figure 42: User Settings
All users can use this window to:
 Change the clinic name (maximum 50 characters)
 Change the date and time (click the Date & Time Picker icon). The Windows
Date and Time window opens.
Figure 43: Change Date and Time
Click Save to save all changes and to return to the Welcome screen. Click Cancel
to discard the changes and to return to the Welcome screen.
An authorized service technician can sign out from the current user and sign in as
a Technician. Click Sign out to open the Password window. Enter an authorized
password to log in. The technician can view the system log and access the system
BIOS and Windows utilities.
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Reviewing and Interpreting the
C-Scan® 2D/3D Images
Reviewing and Interpreting the
C-Scan® 2D/3D Images
Warning: Only a physician trained by Check-Cap in the use of the C-Scan® View should
review the procedure results.
See Chapter 6: Using C-Scan® View to Create the C-Scan® Reconstructed Colon
Display for a description of the steps to download the data from the C-Scan® Track
to the C-Scan® View.
Note: The C-Scan® Cap large bowel (colon) scan coverage may vary due to variations in
patient GI motility.
The movement of the capsule throughout the GI tract is driven by the natural
peristalsis of the bowel. Hence, the total transit time and dynamics of the capsule
propulsion are unpredictable and may substantially vary between patients.
7.1
Understanding the Navigation Bar
Figure 44: Navigation Bar
The C-Scan® View navigation bar contains two tabs:
 Review – Opens the Review screen
 Results - Opens the Results screen
 Report – Opens the Report screen
Select a tab by clicking on it. The selected tab is shown in black.
Review Screens – General
7.2
The viewing screen contains:
 Main window—displaying 2D maps, 3D maps, and motility data
 Segment and slice reference and navigation controls
 Help text with guidelines for evaluating suspects
The system also allows the user to take snapshots that are automatically saved in
the report section where they can later be edited and a report generated and
printed.
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Figure 45: Review Screens-General
1. Home icon
7. Slice navigation bar
2. 2D Maps tab
8. 2D slice display
3. 3D Views tab
9. Segment navigation control
4. Motility tab
10.Bookmarks table
5. Snapshot icon
11.Suspect evaluation wizard
6. Segment timeline
12. Navigation bar
The general functionalities of the Review screens are described in Table 1.
Table 1: Graphics Main Displays and Functionalities
Item
Description
Illustration
Segment and Slice Display
Segment Control
Displays current segment
number out of total number of
segments in the procedure.
Navigation buttons allow
scrolling through segments.
Additional navigation buttons
are available under the 2D
maps
Segment Timeline
Displays the position of the
currently selected slice relative
to the other slices in the
segment. Segments overlap is
indicated.
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Item
Description
Illustration
Procedure info
In the 2D Map view:
Colon length and coverage are
displayed.
Segment Info
In the 2D Map view:
Displays the length, duration,
and distance to rectum for the
selected segment.
The Segment Locator displays
the approximated model of the
scanned colon with the current
segment marked.
or
Displays information about the
similarity of the CMT and XRF
maps.
or
Displays information about the
range validity of the CMT and
XRF maps.
Use this information when filling
out the Suspect Evaluation
wizard dialog.
or
or
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Item
Description
Slice Info
In the 2D Map view:
Illustration
Displays the number of slices
and percentage of time in the
same location as the current
selected slice.
Displays the number of
pressure events in current slice
(counts events in the entire
segment of the current selected
slice, including overlap
segments).
In the 2D Map and Motility
views:
Displays information about local
capsule orientation for the
current slice (in reference to
slices in close proximity).
Displays information about local
capsule mobility for the current
slice (in reference to slices in
close proximity).
Displays information about
global capsule mobility for the
current slice (in reference to all
slices in the procedure).
In slices where the information
is uncertain the status cannot
be determined.
Displays information about
pressure events in current slice
(counts events in the entire
segment containing the
capsule, including overlap
segments).
Use this information when filling
out the Suspect Evaluation
wizard dialog.
Slice Navigation
Bar
The slide navigation bar enables
sliding between slices. The slice
selection is synchronized in all
views, i.e., in the 2D maps, 3D
views, and Motility graphs.
Slice A/P View
2D slice display
A 2D cross section of the
reconstructed segment,
displaying the current slice.
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Item
Description
Illustration
Bookmarks
Once an ROI marks a region of
interest around a suspect in the
2D maps, it can be added as a
bookmark. The segment and
slice number can be clicked
providing quick access to the
marked ROI.
Viewing Modes
2D, 3D, and
Motility Tabs
Use 2D, 3D, and Motility tabs to
select display of 2D maps, 3D
views, or motility information.
2D Maps
2D Height Maps
The 2D height maps represent
2D height of the colon tissue
above the surface as seen from
the inside by the capsule for
CMT and XRF based signals.
To the right of each 2D map, a
color scale is displayed.
56
Region Of
Interest (ROI)
Use the ROI button to mark a
region of interest around a
suspect in the 2D map. The
marked ROI is seen in 3D Views
as well.
Disabled
Enabled
Windowing
Use the Windowing button to
select a window in the 2D map.
The map display changes to
adjust the map dynamic range
according to the range of the
selected window only.
Disabled
Enabled
Gray
Use the Gray button to change
the 2D color scale to grayscale.
Disabled
Enabled
Original/Filtered
Signals for 2D
Map Display
To display both the CMT map
and the XRF map using filtered
signals, click the Filtered tab.
To return to maps using original
signals, click the Original tab.
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Item
Description
Illustration
3D Views
3D display of the colon exterior
allowing the user to zoom
in/out and rotate the tube.
3D Tube Display
3D Fly Through
Display
Changing slice slider position
highlights the selected slice in
blue along the colon tube.
3D display of the colon interior
allowing the user interactive
navigation along the colon
longitudinal axis.
Changing slice slider position
highlights the selected slice in
blue along the colon tube.
A 3D tube "opened to a plane"
(fillet).
3D Plane Display
Changing slice slider position
highlights the selected slice in
blue along the colon "fillet".
Motility
Motility
Information
Four graphs display information
about movement through the
segment:
 Capsule position
 Track sensor movement
 Capsule orientation
 Capsule environment
pressure
A schematic map shows the
capsule position on the
approximated colon model
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Item
Description
Illustration
Suspect Evaluation
58
Suspect
Evaluation wizard
dialog
Suspect Evaluation wizard
dialog can be initiated by
clicking the Wiz button on a
chosen bookmark.
Suspect
Evaluation wizard
dialog
The Suspect Evaluation wizard
is composed of a set of
questions, to be answered by
the user. Some of the questions
are automatically answered by
the wizard, relaying on
automatic slice indicators,
averaged on the slices
composing the ROI, and the
answer can be changed
manually. After filling out the
form, clicking “score” results in
a score between 0 and 1,
representing the statistical
probability the suspect is a
suspicious finding (0 low, 1
high).
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7.3
Action Icons
Action icons are located to the left of the main window.
Figure 46: Mode Selection
Use the tab icons to select the view mode:
 2D maps
 3D views
 Motility information
Figure 47: 3D View Selection
When selecting 3D Views, three view types are available. To switch to another
view, click the corresponding button. The views, described in Section 7.8, are:
 3D Tube
 3D Fly Through
 Fillet (Plane)
In case the display in the main window was edited, use the Home icon (
reset the display to its original state.
) to
Use the Snapshot icon (
) to save an image displayed on the screen. The
number of saved images is shown next to the icon. Up to 50 images can be saved.
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7.4
Segment Control
Figure 48: Segment Control Bar
The Segment Control Bar at the bottom of the screen allows the viewer to scroll
through the colon segments.
The current segment number and the total number of segments are displayed, as
in the example: “Segment 25 of 29”. Any segment number within the range of
segments can be entered in the text box to enable viewing the corresponding
segment.
7.5
Slice Control
Figure 49: Slice Control Bar
Use the Slice control bar to select a specific slice within the currently selected
segment.
7.6
Segment Timeline
Figure 50: Segment Timeline
The Segment timeline displays the position of the currently selected slice relative
to other slices in the segment. The green portion of the timeline is an overlap that
also appears in the neighboring segment. An overlap with the next segment
corresponds to a green portion on the right side and an overlap with the previous
segment corresponds to a green portion on the left side.
7.7
2D Map Mode
The 2D height maps represent 2D height of the colon tissue above the surface as
seen from the inside by the capsule for CMT and XRF based signals.
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Figure 51: CMT and XRF Maps: No Suspect
In Figure 51 the 2D maps show the CMT and XRF data of a segment with no
suspicious finding or lesion.
Click a 2D map and use the left and right keyboard arrows to control the slice
angular rotation in the 2D maps. Once the angular rotation changes, an indication
(a dot mark) will appear next to the angular axis. Click the Home icon to reset the
angular change.
Click the Windowing button under a 2D map and select a window in the map to
change the dynamic range of the map according to the range of the selected
window. Click the Home icon to reset the dynamic range map.
Click the ROI button under either of the maps to mark a region of interest around
a suspect region. The ROI is marked in both maps for easy comparison between
the maps.
Please refer to DOC001212 C-Scan View Physician training document for
more information on interpreting 2D images and identifying suspects
Figure 52: Region of Interest (ROI)
7.8
3D View Mode
7.8.1
3D Tube Mode
3D Tube Mode shows the outside of the colon segment. Select the segment
number to be reviewed, or continue reviewing the same segment reviewed in one
of the other modes. Click on Next Segment to move to the next segment, or
Prev. Segment to move to the previous segment. The approximate location of
the segment is highlighted in blue on the Colon Segment Locator. A particular slice
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can be selected using the slice control bar, moving the slider by clicking and
holding the mouse pointer on it, and moving the mouse to the desired location.
Use the mouse to control the movement of the colon reconstruction as follows:
 Tube pan is controlled by the right mouse button.
 Tube zoom in/out is controlled by the mouse scroll wheel.
 Tube rotation is controlled by the left mouse button.
7.8.2
Fly Through Mode
Fly Through Mode shows the inside of the colon. The reconstruction starts with the
first segment at the proximal end of the colon. Click on Next Segment to move to
the next segment, or Prev. Segment to move to the previous segment. The
approximated location of the segment is highlighted in blue on the Colon Segment
Locator. A particular slice can be selected using the slice control bar, moving the
slider by clicking and holding the mouse pointer on it, and moving the mouse to
the desired location.
Use the mouse to control the movement of the colon reconstruction as follows:
 Fly through movement is controlled by the mouse scroll wheel
 Fly through angle is controlled by the left mouse button.
A segment with a suspicious finding is displayed in Figure 53:
Figure 53: Colon Segment with Suspicious Finding
Click Next Segment, or enter a segment number to continue the review.
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7.8.3
Fillet Mode
Fillet Mode opens the 3D Tube and shows the inside of colon segment. Select the
segment number to be reviewed, or continue reviewing the same segment
reviewed in one of the other modes. Click on Next Segment to move to the next
segment, or Prev. Segment to move to the previous segment. The approximate
location of the segment is highlighted in blue on the Colon Segment Locator. A
particular slice can be selected using the slice control bar, moving the slider by
clicking and holding the mouse pointer on it, and moving the mouse to the desired
location.
Use the mouse to control the movement of the colon reconstruction as follows:
 Fillet movement along the axis is controlled by the mouse scroll wheel.
 Fillet rotation is controlled by the left mouse button.
 Fillet pan is controlled by the right mouse button.
 Use the left and right keyboard arrows to move the fillet cut line (the fillet
rotates around the cut line).
 Use the left and right keyboard arrows to control the slice angular rotation. Click
the Home icon to reset the angular change.
7.9
Motility Information
Four graphs display information about movement through the segment. The
vertical lines in each graph represent the slices composing the segment.
The Capsule Position graph (Figure 54) shows the X, Y, and Z coordinates of the
capsule throughout the segment.
The local mobility status is derived from the capsule position, options are
static/dynamic. In some cases, the track sensors cause invalid position changes,
and then the automatic indicators cannot be determined. “Local mobility” indicator
options are both colored in grey in this case.
The global mobility status is derived from the number of slices and the time spent
in the current slice, options are static/dynamic.
Figure 54: Capsule Position Graph
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The Track Sensors graph (Figure 55) shows the movement of the left and right
sensors of the C-Scan® Track throughout the segment.
Figure 55: Track Sensors Graph
The Capsule Orientation graph (Figure 56) shows the change of the capsule's
orientation throughout the segment: pitch, yaw, and ∆ (a measurement
representing the maximal angular changes of the capsule).
Slice status is considered static if ∆< 35°. See examples in Table 4.
In some cases, the track sensors cause invalid orientation changes, and then the
automatic indicators cannot be determined. “Local orientation” indicator options
are both colored in grey in this case.
Figure 56: Capsule Orientation Graph
The Capsule Environment graph (Figure 56) shows the changes in pressure and
temperature in the capsule environment. Immediately after a slice is captured, a
peak in pressure and temperature occurs. Those peaks are not relevant for
suspect analysis. Any other peaks in pressure that occur in the segment are
marked with an orange ball.
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Figure 57: Capsule Environment Graph
In the top right of the screen, the capsule position on the colon model is shown
(Figure 58).
Figure 58: Capsule Position in Colon
7.10
Evaluating Suspects
When a suspect is identified, add it as a bookmark and start the analysis wizard
process.
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Figure 59: Suspect Analysis Wizard
Answer the questions in the form. When the Evaluate button is clicked, a score
(between 0 and 1) is generated. The higher the score, the greater the statistical
likelihood of the suspect being a suspicious finding. The analysis wizard algorithm
compares the suspect profile, built using the physician answers, to a clinical
database, and determines how statistically similar it is to a suspicious finding
profile.
Use the suggested score combined with personal evaluation of the suspect to
decide whether the finding is suspicious or not. Personal evaluation is based on the
suspect reliability and clinical experience.
The questions refer to the suspect’s visibility, quality, 3D&2D appearance, and
sensors information around the suspect. Every answer can increase / decrease
suspect reliability, but no one answer by its own can determine if a suspect is a
suspicious finding or not.
There are several indicators related to slice and segment info that support
answering some of the questions. These indicators are calculated by the C-Scan
View automatically and the automatic answer is chosen in the analysis wizard
form. It is possible to change the automatic answer. Make sure that the indicators
reflect the actual status correctly (based on experience). If not, answer the
question differently.
Indicators status is colored as follows:

Yellow –more likely to support case of suspicious finding / increases
suspect reliability

Blue - less likely to support case of suspicious finding / decreases suspect
reliability

Green –somewhere between blue and yellow
Note, determining if a suspect is a suspicious finding or not requires the full
picture, and cannot be determined solely by relying on a single indicator. A
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suspicious finding can include several green/blue indicators and a non-suspicious
finding can include several green/yellow indicators.
The questions are specified below:
Figure 60: Suspect Visibility
Answer the question about suspect visibility based on your personal assessment
(refer to the Help text and diagrams for illustrations, by hovering over the
question mark icon ). A suspect seen in both maps is more reliable.
Figure 61: Help Text and Diagrams for Suspect Visibility
An example of good visibility on both maps is shown in Figure 62
Figure 62: Example of Good Visibility on Both Maps
An example of poor visibility on one map is shown in Figure 63.
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Figure 63: Example of a Poor Visibility on One Map (CMT)
An example of a suspect visible on one map only is shown in Figure 64.
Figure 64: Example for Suspect Visible on One Map Only (XRF)
Figure 65: Suspect Quality
Assess suspect intensity, scan consistency, shape/width, and background (refer to
the Help text and diagrams for illustrations, by hovering over the question mark
icon ).
Figure 66: Help Text for Suspect Quality
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Options marked orange are considered positive, and options marked blue are
considered negative. The suspect quality assessment concludes the quality
characteristics answers to a final answer – Low/Medium/High. This final answer
can be changed manually.
The more positive indicators, the higer the suspect quality, meaning a more
reliable suspect.
See examples in Table 2.
Table 2: Suspect Quality Examples
Background
Partial:
Full:
Shape/
width
Wide (over a third of the angular
range):
Normal:
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Scan
consistency
(For scans to
be considered
close to one
another, the
time
difference
should be
< 60 sec.)
1 side/none:
2 sides:
Suspect
intensity
Weak (under ~3 mm difference
between suspect and background):
Strong (above ~3 mm difference
between suspect and background):
Figure 67: Asymmetrical Protruding in 3D View
Mark the suspect with an ROI. Then, switch to 3D Views and examine suspect
visibility in 3D models (Refer to the Help text and diagrams for illustrations, by
hovering over the question mark icon ). A suspect that is prominent in 3D as well
as 2D is more reliable.
Figure 68: Help Text for Asymmetrical Protruding
See examples of 3D protruding in Table 3.
Table 3: 3D Examples
Asymmetrical 3D protruding:
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Symmetric 3D protruding:
Figure 69: Local Orientation
The capsule local orientation in the marked ROI is evaluated and the averaged
orientation status is chosen automatically in the analysis wizard. This status can
be changed manually.
Capsule local orientation in the vicinity of slices composing the suspect can be
examined in the motility tab.
The Capsule Orientation graph shows the change of the capsule orientation
throughout the segment: pitch, yaw, and ∆ (a measurement representing the
maximal angular changes of the capsule).
Slice status is considered static if ∆< 35°. See examples in Table 4.
In some cases, the track sensors cause invalid orientation changes, and then the
automatic indicators cannot be determined. “Local orientation” indicator options
are both colored in grey in this case.
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Fluctuates status is more likely to appear around a suspect, since the capsule has
to move around a suspicious finding. “Local orientation” indicator is colored
accordingly, “Fluctuates” option in yellow and “Fixed” option in blue.
Table 4: Capsule Orientation Examples
Fixed local
orientation
Fluctuates
local
orientation
Status
cannot be
determined
(due to track
sensor issue)
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Figure 70: Pressure Events
Pressure events are identified and counted in each segment.
The pressure status in the analysis wizard is chosen automatically from the
pressure indicator. This status can be changed manually.
False detection or miss-detections of pressure events can occur. If the user
recognizes an event with more than 3 samples and amplitude higher than
~0.25 mm Hg, it can be referred to as a pressure event.
Immediately after a scan is captured, a peak in pressure and temperature graph
occurs. Those peaks are not relevant for suspect analysis. True pressure events
are reflected only in the black pressure graphs, while the temperature graph
remains smooth at the same time points.
 Multiple events correlated with events in orientation are not detected by the
pressure indicator and can be detected by the user.
A pressure event near the polyp is considered a positive indicator for a suspicious
finding. Pressure events indicator is colored accordingly, “High” option in yellow,
“Medium” option in green and “Low” option in blue.
See examples in Table 5.
Table 5: Pressure Event Examples
None - (Low)
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Single unmarked
event (Medium)
Single marked event
(Medium)
Unmarked multiple
events (Medium)
Marked multiple
events (High)
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Multiple events
correlated with
events in orientation
(High)
The following questions are do not affect the wizard statistical analysis and are saved for
research and statistical analysis only.
Figure 71: Colon Model Location
Check the segment location in the Segment Locator on the 2D Maps tab and the
capsule position on the Motility tab. Then, select the approximate location of the
suspect in the colon (Refer to the Help text and diagrams for illustrations, by
hovering over the question mark icon ).
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Figure 72: Help Text for Suspect Location
Figure 73: Clinical Opinion
Select the answer that matches your overall opinion about the suspect, relaying on
your own clinical experience.
When the “Score” button is clicked, a score (between 0 and 1) is generated (see
Figure 74). The higher the score, the greater the statistical likelihood of the
suspect being a suspicious finding. The wizard’s algorithm compares the suspect
profile, built using the physician answers, to a clinical database, and determines
how statistically similar it is to a suspicious finding profile. A score above 0.4 is
considered as a high score.
Suspicious findings can be marked and sent to the report (see Figure 74).
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Figure 74: Suspect Analysis Result
The answers used by the algorithm are saved in the Results tab (Figure 75).
Use the suggested score combined with personal evaluation of the suspect to
decide whether the finding is suspicious or not. Personal evaluation is based on the
suspect reliability and clinical experience. Log suspicious findings in the report tab.
Please refer to DOC001212 C-Scan View Physician training document for
more information about analyzing suspects
7.11
Results Screen – General
All suspects’ evaluation are saved in the results screen (Figure 75). Analysis
results can be deleted using the delete button. Suspects can be sent to the report
from the results screen.
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Figure 75: Results Tab
7.12
Imaging Data Validity
The reconstruction algorithm performs a validity check on all scanned data
acquired by the capsule.
The reconstruction algorithm is designed to filter faulty scans only, while not
affecting proper clinical data. Minor issues may still be visible, resulting in a few
artifacts (See examples in Table 6).
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Table 6: Images with Artifacts
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Creating a C-Scan® System Report
Creating a C-Scan® System Report
Figure 76: C-Scan® View Report Screen
1. Patient field
2. Procedure field
3. Screen capture field
4. Suspicious findings field
5. Physician comment fields
6. Physician name
7. Generate CD and Print icons
The Report screen displays all the patient data that was entered at the beginning
of the procedure and the snapshots taken during the review.
8.1.1
Patient Field
Figure 77: Patient Field
The Patient Field shows the patient name and ID that were entered at the
beginning of the session. The fields are editable and can be changed or updated.
8.1.2
Procedure Field
Figure 78: Procedure Field
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The Procedure Field displays the C-Scan® Cap Serial Number and the C-Scan®
Track Serial Number. Remarks that were entered in the Patient Details window at
the beginning of the procedure are displayed in the remarks field. This field is
editable, allowing additional remarks, up to the 1000 character limit.
Figure 79: Screen Capture Field
The Screen Capture Field displays all the screen captures taken during the review
session. Click on the arrows to scroll through the screen captures. Each screen
capture is numbered consecutively.
Each screen capture in the report window has an exit button (X) next to it. Delete
any unwanted snapshots by clicking on the X to the left of the snapshot.
8.1.3
Physician Comment Fields
Figure 80: Physician Comment Fields
The Physician Comment Fields contains editable fields for the physician to record
findings, remarks and recommendations. The fields are:
 Summary & Recommendations – Maximum length is 1000 characters.
 Physician Name – Maximum length is 20 characters.
The Report Window also contains two icons:
 Generate CD – Make sure there is a blank writable CD in the CD drive, wait a
while after inserting the CD before the burn process can start and then click
Generate CD to create a procedure results CD. The procedure 3D reconstructed
results and the PDF report are copied to the CD.
Note: The C-Scan® View does not save the raw data.
The CD generation process is displayed in a series of pop-up windows. Once the
process is done, a message indicates the CD was successfully created.
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Figure 81: Generate CD Progress
CD generation can be cancelled at any point in generation process. Click Cancel to
stop the process. A window pops up – click Close to return to the Report screen.
Figure 82: Generate CD Cancel
If the CD creation failed, a notification message appears with the following text:
"Failed to create a CD. Please insert a blank CD."
 Print – Press the Print icon to print the report on the attached printer.
Figure 83: C-Scan® Report – 4 Structured Pages
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Creating a C-Scan® System Report
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Ordering the C-Scan® Kit and Disposing of the Used Components
Ordering the C-Scan® Kit and
Disposing of the Used Components
Before ordering the C-Scan® System:
 Check the local code for handling radioactive devices. See Chapter 10: Technical
Description for the C-Scan® Cap technical specifications.
 Check the clinic procedures for receiving, handling, and storing radioactive
devices.
 Verify who is certified to receive the shipment. This person should be the only
one to receive the C-Scan® System and must be trained in handling, receiving,
and storing radioactive devices.
9.1
Ordering the C-Scan® Cap
9.1.1
Before Ordering
 Discuss the examination with the patient, obtain the patient approval, and have
the patient sign the consent form.
 Provide instructions to the patient regarding preparing for the procedure.
 Set the date and time for ingestion. Due to the manufacturing restrictions of the
C-Scan® Cap, designating a set day of the week for ingestion will help ensure
receipt of the C-Scan® System in a timely manner.
9.1.2
Ordering
Contact Check-Cap to order the C-Scan® System:
Address
Check-Cap Ltd.
29 Abba Hushi Ave.
P.O.Box 1271
Isfiya, 3009000
Israel
Telephone
+972-4-821-1258
Fax
+972-4-821-1267
Email
info@check-cap.com
Note: Order the C-Scan® System at least two weeks prior to the procedure date, as the
radioactive material is inserted into the C-Scan® Cap on a “just-in-time” basis to maintain
the longest possible capsule life. The radioactive core is inserted into the C-Scan® Cap
just prior to shipping.
Upon receipt of the order, Check-Cap:
 Plans production and hot assembly time line
 Assembles, tests, pairs, and packages the C-Scan® System
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Ordering the C-Scan® Kit and Disposing of the Used Components
 Ships the C-Scan® System to the clinic by courier certified to carry radioactive
devices
Note: The shipment is sent door to door and not to the clinic storeroom. The clinic must
have its dedicated person with a permit for handling RA materials, on site to receive the
shipment. Do not break the seal on the C-Scan® Kit box. This should be done only by the
physician, nurse, or technician at the time of the procedure.
Returning the C-Scan® Cap
9.2
Once the C-Scan® Cap is expelled, the patient should follow the directions in the
Instructions for Use for returning the C-Scan® Cap and C-Scan® Track to the clinic.
The clinic’s designated person should then do the following:
1. Pack the C-Scan® Cap in the original box and place it back in the original
package. This action complies with the requirements for keeping the proper
distance from the radioactive device.
The contrast agent and other accessories and consumables should stay with
the clinic. They can be used by other patients as long as they do not expire
and are still in their original intact condition.
Discard the patient's kit according to local codes and guidelines.
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Technical Description
10
Technical Description
10.1
System Labeling
System:
Labeling
Explanation
CEpartner4U BV
Esdoornlaan 13
EC Rep
3951 DB Maarn
The Netherlands
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Technical Description
Labeling
Explanation
CE Mark
Single use only - Do not
re-use.
Consult accompanying
documents (required to
consult for Safety)
Serial number
Manufacturer
Date of Manufacture
[YYYY,MMM,DD]
Use-by date [YYYY,
MMM, DD]
“Caution: Federal law
restricts this device to
sale by or on the order
of a (licensed healthcare
practitioner)."
Caution, consult
accompanying
documents
Do not use if the
package is damaged
Non-ionizing radiation
Radioactivity
Type BF equipment
Catalogue number
Keep dry
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Labeling
Explanation
Fragile, handle with care
Humidity limitation
Product contains natural
rubber latex
Temperature limit
LOT number
Not for general waste
"I-White" label - Safe
transport of radiation
material label
10.2
C-Scan® Kit Labels
Each C-Scan® Kit box has a label on the cover as shown in Figure 85. Each box is
marked with the expiration date, lot number, and a unique C-Scan® Kit serial
number.
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Technical Description
Figure 84: C-Scan® Kit Labels
10.3
C-Scan® Cap Label
Each capsule box has a label at the bottom as shown in Figure 85. Each capsule is
marked with the expiration date, lot number, and a unique capsule serial number.
Figure 85: C-Scan® Cap Label
10.4
C-Scan® Track Label
The C-Scan® Track has two labels on the sensor units as shown in Figure 86. Each
C-Scan® Track is marked with a unique serial number.
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Technical Description
Figure 86: C-Scan® Track Labels
10.5
C-Scan® View Labels
The C-Scan® View has four labels. 3 Packing labels on the PC package, Monitor
package and Printer package and a label on top of the PC as shown in Figure 86.
Each C-Scan® View is marked with a unique serial number.
Figure 87: C-Scan® View Labels
10.6
Essential Performance
10.6.1
C-Scan® Cap
The C-Scan® Cap has 3 modes of operation: Standby, BIT and Active. Upon power
connection the C-Scan® Cap switches to Standby mode. The C-Scan® Cap stays in
Standby mode as long as it does not receive a valid wakeup request to switch to
BIT mode, from the C-Scan® Track via the communication channel.
Once, a valid wakeup request is received by the C-Scan® Cap it switches to BIT
mode and only if all BIT tests are successfully passed the C-Scan® Cap switches to
Active mode. In Active mode the C-Scan® Cap continually communicates with the
C-Scan® Track and performs scans until it is expelled from the body.
10.6.1.1
Standby Mode
Standby mode is C-Scan® Cap lowest power consumption mode. In this mode CScan® Cap main microcontroller doesn't execute any operations and the only
active unit is the communication unit, which is completely autonomic.
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10.6.1.2
BIT Mode
System BIT process is a test sequence between a C-Scan® Cap and C-Scan® Track
with matching IDs. During this process each subsystem verifies its proper
functionality. Some of the tests are autonomic and some require the
participation of both subsystems. The final approval of the system BIT is granted
only by the C-Scan® Track. If the C-Scan® Cap does not receive system BIT
approval\disapproval after completing BIT execution, the C-Scan® Cap switches
back to Standby mode.
10.6.1.3
Active Mode
Active mode is C-Scan® Cap main mode of operation. Only in Active mode the CScan® Cap can perform scans and transmit acquired data.
X-ray transmission occurs only while the C-Scan® Cap is in motion inside the
colon, limiting radiation exposure. To detect C-Scan® Cap motion, the C-Scan®
Cap generates a positioning signal, which is interpreted by the C-Scan® Track
Scan Control Algorithm which then informs the C-Scan® Cap to open the
concealment cover and begin the scan. When the C-Scan® Track determines that
the motion has ended, the C-Scan® Cap's X-ray source is concealed. In this mode,
radiation leakage measured on the capsule surface does not exceed 0.05% of
source activity.
The C-Scan® Cap verifies that the X-ray source is concealed. If the X-ray source is
not concealed, the C-Scan® Cap sends a message to the C-Scan® Track informing
it that the X-ray source is exposed. It continues to send the message until the CScan® Track acknowledges. If the problem is not resolved by the C-Scan® Track, it
sends a malfunction indication to the patient, who should contact the clinic
immediately.
10.6.2
C-Scan® Track
The C-Scan® Track is an external device attached to the patient back. The CScan® Track tracks the C-Scan® Cap position, sends commands to the C-Scan®
Cap, receives and stores imaging data sent by the C-Scan® Cap, and interfaces at
the end of the procedure with the C-Scan® View.
The C-Scan® Track has several main modes of operation:
 Idle mode – includes sleep mode
 Calculation cycle mode – a single process of C-Scan® Cap position estimation
and full SCA calculation
 C-Scan® Cap temperature/pressure data transfer mode - C-Scan® Cap sensor
data is received through RF
The C-Scan® Track consists of the following units:
 Positioning System - a localization device that tracks and records the position
and orientation of the C-Scan® Cap, enabling intra-colon mapping for the
purpose of colon surface imaging.
 Data Recorder - a recording device that captures the C-Scan® Cap data
(imaging, etc.) to a non-volatile memory. Data transmission is through RF
communication during the C-Scan® Cap transition in the GI tract. The recorder
also enables data retrieval through the USB Interface Unit following procedure
completion.
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 Processing Unit – an embedded device that controls localization and recording
functions, running an embedded Scan Control Algorithm through which the CScan® Cap’s scan mechanism is operated.
 User Interface Unit – Sends status indicators to the patient.
 USB Interface Unit – USB interface that enables data transfer from the C-Scan®
Track to the C-Scan® View, as well as production and service needs.
10.6.3
C-Scan® View
The C-Scan® View is an offline, standalone application that processes and displays
the data acquired by the C-Scan® System. The C-Scan® View imports procedure
data from the C-Scan® Track, manages patient information, displays the 3D colon
reconstruction, and generates a procedure report and a results CD.
10.7
System Specifications
Note: Specifications are subject to change without prior notice and without any
obligation to users on the part of the manufacturer.
Note: Specifications are rounded to the appropriate decimal place.
Table 7: Technical Specifications
C-Scan® Cap
Mechanical Dimensions (Length x
Diameter)
35mm x 12mm (1.4” x 0.5”) +/- 5%
Weight
13 gram (0.5 oz.)
Material
Biocompatible
X-ray source
W-181 (Tungsten)
The C-Scan® Cap radiation source is assembled within a 3mm-thick Tungsten
concealment. It also incorporates a permanent shielding of 0.5mm-thick Aluminum foil,
as part of the radiation canister structure.
RADIATION QUALITY is constant, guaranteed, and verified, thanks to isotope-based
source. Hence no ADDED FILTER required.
In normal use, dose levels might increase mainly due to abnormal motility, i.e. the
capsule remaining static. Procedure duration then limits the dose level to two orders-ofmagnitude lower than the acceptable threshold for deterministic effects.
The RADIATION DETECTORS integrated into the C-Scan® Cap are based on CdTe/CZT
crystals, demonstrating nearly-perfect Quantum Efficiency within the imaging energies
range.
The maximum total attenuation of all items interposed between the patient and the
radiation detectors is equivalent to less than 0.2mm thick Aluminum layer.
The C-Scan® Cap radiation source housing ensures negligible exposure to any OPERATOR
or STAFF.
Hot phase shelf life
Up to 2 weeks
Operating Temperature
+5ºC (41ºF) to 45ºC (113ºF)
Operating Humidity
100% Relative Humidity
Operating Pressure
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Storage and Transportation Temperature
-10ºC (-4ºF) to 45ºC (113ºF)
Storage and Transportation Humidity
10 to 80% Relative Humidity
Storage and Transportation Pressure
520 mmHg to 1200 mmHg
Operating Frequency RF Band
433.5 MHz ±127 KHz
RF Modulation Type
2 FSK , 38.4 Kbit/sec
Effective Radiated Power
10 dbm
Battery Type
Silver Oxide - 399ZGB (0% mercury)
Battery Life
maximum 100 hours
C-Scan® Track
Mechanical Dimensions Sensor Unit
(Length x Width x Depth)
<100 mm x 100 mm x 20 mm (1.4” x .5”)
Weight Sensor Unit
< 60 grams
Mechanical Dimensions Power Unit (Length
x Width x Depth)
50 mm x 50 mm x 20 mm
Weight Power Unit
<30 gram
C-Scan Track Weight
250 gram (.5 oz)
Material
Withstands common detergents and
perfumes, isopropyl alcohol (IPA),
Methylated spirit and water swiping
Operating Temperature
+5C to +45C
Operating Humidity
10 to 80% Relative Humidity
Mechanical Shock
300 m/s2 (30g) duration 6 ms
Water Drops
IP24
Storage and Transportation Temperature
-10ºC (-4ºF) to 45ºC (113ºF)
Storage and Transportation Humidity
10 to 80% Relative Humidity
Storage and Transportation Pressure
520 mmHg to 1200 mmHg
Operating Frequency RF Band
433.5 MHz ±127 KHz
RF Modulation Type
GFSK
Effective Radiated Power
10 dbm
Battery Type
AA Lithium 03-2033
Battery Life
Max. 100 hours
®
10.8
Guidance and Manufacturer’s Declaration
Table 8: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The C-Scan® System is intended for use in the electromagnetic environment specified below.
The customer or the user of the C-Scan® System should assure that it is used in such an
environment.
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Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF emissions CISPR 11
Group 1
The C-Scan® System uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC
61000-3-2
Not
applicable
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Not
applicable
Table 9: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The C-Scan® System is intended for use in the electromagnetic environment specified
below. The customer or the user of the C-Scan® System should assure that it is used in such
an environment.
IMMUNITY test
IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
± 6 kV
contact ± 8
kV air
± 6 kV
contact ± 8
kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for
power
supply
lines;
± 1 kV for
input/output
lines
N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Surge IEC
61000-4-5
± 1 kV
line(s) to
line(s) ± 2
kV line(s) to
earth
N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<5 % UT
N/A
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the C-Scan® System requires
continued operation during power mains
interruptions, it is recommended that the CScan® System be powered from an
uninterruptible power supply or a battery.
(>95 % dip
in UT) for
0,5 cycle
40 % UT
(60 % dip in
UT) for 5
cycles
70 % UT
(30 % dip in
UT) for 25
cycles
<5 % UT
(>95 % dip
in UT) for 5
DOC000300 / C-SCAN User Reference Manual
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Technical Description
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE:
3 A/m
3 A/m, 50
Hz
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
UT is the AC mains voltage prior to application of the test level.
Table 10: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The C-Scan® System is intended for use in the electromagnetic environment specified below.
The customer or the user of the C-Scan® System should assure that it is used in such an
environment.
IMMUNITY
test
IEC 60601
TEST
LEVEL
Compliance
level
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the C-Scan® System, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted
RF IEC
61000-4-6
3 Vrms
150 kHz
to 80
MHz
N/A
Radiated
RF IEC
61000-4-3
3 V/m
80 MHz
to 2,5
GHz
3 V/m
80 MHz to
2,5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
deter-mined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
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DOC000300 / C-SCAN User Reference Manual
Technical Description
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
A Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the C-Scan® System is
used exceeds the applicable RF compliance level above, the C-Scan® System should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the C-Scan® System. b Over
the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
10.9
Compliance with FCC regulations:
Statement: This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to part 15 of the FCC Rules. See 47 CFR Sec.
15.105(b). These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses
and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in
a particular installation. If this equipment does cause harmful interference to radio
or television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more of the
following measures:
 Reorient or relocate the receiving antenna.
 Increase the separation between the equipment and the receiver.
 Connect the equipment to an outlet on a circuit different from that to which the
receiver is connected.
 Consult the dealer or an experienced radio/TV technician for help.
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Troubleshooting
11
Troubleshooting
11.1
C-Scan® View
11.2
11.3
11.4
11.5
98
Problem
Cause
Action
C-Scan® View error:
Load CD Failure Screen
CD DAMAGED
Contact Customer Support
C-Scan® View error:
Processing Data Failed
DATA FAILURE
Contact Customer Support
Downloading Data from C-Scan® Track
Problem
Cause
Action
C-Scan® View error:
Failed to connect to CScan® Track.
C-Scan® Track connection
Please check C-Scan® Track
connection”. Check the C-Scan®
Track connection to the PC and
click OK to close the message and
return to the Welcome screen.
Printer
Problem
Cause
Action
Cannot print report
Printer is turned off
Turn printer on
Printer is not set as default
printer
Set printer to Default Printer
Printer has a malfunction
Contact Customer Support
Problem
Cause
Action
Cannot burn CD/DVD
CD/DVD is not blank or
compatible with CD/DVD
ROM
Contact Customer Support
Wrong burning procedure
Insert a new CD/DVD and burn
again
CD/DVD
C-Scan® Kit
Problem
Cause
Action
Pairing fails, it is indicated by
a longer series of Beeps (5
sec.).
C-Scan® Cap
failure
Please contact Check-Cap for
possible actions.
DOC000300 / C-SCAN User Reference Manual
Troubleshooting
Capsule malfunction indicated
by repeated Audible beeps
DOC000300 / C-SCAN User Reference Manual
Open
Concealment
mechanism
causing high
radiation
exposure
The physician should invite the
patient to clinic and consider
various options to remove capsule
out of the GI tract.
99
Information for User
12
Information for User
This section contains all the information in the Patient Diary plus additional
instructions for the clinic.
12.1
Patient and Clinic Information
The following information should be entered on the front page of the Patient Diary:
 Patient Name (and a copy of the patient clinic sticker, if one exists)
 C-Scan® Track Serial Number
 Clinic Contact Information (usually a sticker)
12.2
Activities Allowed During the Procedure
The following activities are allowed during the procedure:
 Eat normally. There are no restrictions as to the type of food.
 Daily routine, except for those activities listed in Section 12.3.
 Work
 Sleep
 Driving/riding in car or public transportation
 Sitting, standing, walking
 Taking a shower (leaving the Recorder attached to the back)
12.3
Activities Not Allowed During the Procedure
 Full-body immersion in water, such as:
 Taking a bath
 Swimming
 Hot tab (Jacuzzi)
 Active sport such as
 Jogging
 Physical exercise in the gym
 Sauna
 Ball-games
 Skiing
 Contact sports
 Travel. For example:
 Flights
 Boat trips
 Long train trips
 Long car trips
 Close proximity to areas with high electromagnetic fields such as: high voltage
electric poles, transformer stations, radio and TV transmitter stations, etc.
 CT or MRI procedures (unless it is an emergency, then be sure to notify the
medical team about the capsule and Track).
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Information for User
12.4
Must Do
The following activities are required during the procedure:
 Take all medications as normal
 Take the Contrast Agent and Fiber at the designated times – morning, noon,
and evening. Each vial contains one portion.
 Keep the Patient Diary with you and keep a record of your activities
12.5
Patient Bag Checklist
Check the Patient Bag against this inventory list. If anything is missing, contact
the clinic.
Patient Bag Inventory List
12.6

15 portions Fiber Supplement/Contrast Agent

5 Stool Collection Devices

1 FIT Kit (For clinical study only, not required for normal use of the device)

3 Pairs Disposable Gloves

1 Tong

Sealable Plastic Bags

5 Alcohol

3 Extra Stickers
Keeping Your Patient Diary
The Patient Diary is an important part of the procedure. Make sure you read it and
understand the procedure. Enter the time that the activity is performed – no other
input is necessary.
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Information for User
Activity
Day 1
Day 2
Day 3
Day 4
Day 5
Morning-Take
Contrast
Agent/Fiber
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Noon - Take
Contrast
Agent/Fiber
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Evening - Take
Contrast
Agent/Fiber
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Breakfast
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Lunch
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Dinner
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Shower 1
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Shower 2
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Sleep
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Driving
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
Bowel Movement
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
Enter Time
Enter Time
Enter Time
Enter Time
Enter Time
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
 Used Collection
Kit
Briefly Describe
Briefly Describe
Briefly Describe
Briefly Describe
Briefly Describe
Bowel Movement
Bowel Movement
Other
12.7
Using the Stool Collection Device
Note: Make sure you use a collection device for every bowel movement.
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DOC000300 / C-SCAN User Reference Manual
Information for User
12.7.1
Attaching the Stool Collection Device Container
Figure 88: Using the Stool Collection Device – Lay on Top of the Toilet Seat
1. Place the single use container onto the toilet bowl, on top of the seat. Be sure
to orient it to fit into the seat.
Figure 89: Using the Stool Collection Device and Accessories
2.




Prepare the required accessories needed for retrieving the capsule:
Gloves
Plastic bag
Tongs
Alcohol wipes
3. Have the bowel movement (do not use toilet paper yet).
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Information for User
4. Pay attention to audible indication of capsule excretion. The C-Scan® Track
signals when the capsule is excreted.
5. Stand up and look into the container and search for the capsule (use the
gloves and tong
6. Use the tongs to retrieve the capsule from the collection container.
7. Rinse the capsule under running water and place it in the plastic bag.
8. Place the plastic bag with the capsule in the Procedure Bag to return to the
clinic.
Caution: Do not urinate into the collection container.
12.8
Retrieving the Capsule at the End of the Procedure
1.
2.
3.
4.
12.9
The C-Scan® Track signals when the capsule is excreted.
Use the tongs to retrieve the capsule from the collection container.
Rinse the capsule under running water and place it in the plastic bag.
Place the plastic bag with the capsule into the cardboard box and then in the
Procedure Bag to return to the clinic.
In Case of Malfunction
If you get a malfunction indication, consisting of repeatable audible beep and
vibration, contact the clinic.
12.10
When to Call the Clinic
Note: If you feel something is not right, at any time during the procedure or immediately
after, contact the clinic.
If any of the following occur, contact the clinic for further directions:
 Any sensation of pain or discomfort
 The C-Scan® Track sends a malfunction indication
 One or more C-Scan® Track sensors detaches from the sticker
 One or more C-Scan® Track stickers detach from the body
 Capsule is expelled
 After 4 days the capsule is not expelled
12.11
Guidelines for the Clinic
The following are possible calls you may receive from the patient, and suggested
actions you should take (see figure 90 flow chart in last page).
 Capsule is Not Found After C-Scan® Track Indicates it Was Expelled
o Advise the patient to look in the toilet. If it is found, the patient should bring
it to the clinic.
o If the capsule is not found, the patient should speak with a physician at the
clinic as there is a chance it wasn’t expelled despite the positive indication.
The physician might recommend using a laxative at home to try to expel the
capsule. Make sure that the patient knows to use the collection kit during
any bowel movements. Or, the physician might recommend coming to the
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Information for User
clinic to examine the patient personally. In all cases, the clinic protocols and
the physician determine the course of action.
 Capsule Not Expelled After 4 Days
o If 4 days have passed and the capsule was not expelled, the patient should
speak with a physician at the clinic (if needed, be sure to initiate a contact
with the patient). The physician might recommend using a laxative at home
to try to expel the capsule. Make sure that the patient knows to use the
collection kit during any bowel movements. Or, the physician might
recommend coming to the clinic to examine the patient personally. In all
cases, the clinic protocols and the physician determine the course of action.
 Technical Malfunction – C-Scan® Track Sent a Fault Indication
o Verify that the indication was from the C-Scan® Track and not a
background noise. A C-Scan® Track safety fault indication is identified by a
series of repeated beeps
o Ask the patient if a single indication was received, or was it repeated at
regular intervals.
o Ask if the patient feels something.
o If it is a Safety malfunction (risk of higher than usual body radiation
exposure), have the patient come to the clinic ASAP.
o The clinic team (technician and/or physician) should perform, in case the
capsule has not been excreted and collected already, abdominal X-Ray to
assure the capsule location within the GI tract.
o In the case of Safety Malfunction, intervention is required to remove the
capsule without delay (recommended within 24 hours). Intervention, based
on the physician's decision and imaging of the capsule's location, may
include: use of laxatives, fibers, removal by colonoscopy, or by surgery.
o Efforts should be made to minimize the patient's exposure by removing the
capsule out of the body.
Note:
Once the faulty capsule is out (by natural excretion or removed by colonoscopy)
place it in the Kit box and notify the sponsor ASAP
 Sensor or Recorder Detaches from Body
 Ask the patient:
o Did the C-Scan® Track fall from the sticker?
If one or more sensors detach from the sticker, have the patient
reattach the sensor to the Velcro. Mark in the diary that the sensor fell.
o Did the sticker detach from the body?
If one or more stickers detach from the body, have the patient try to
attach a new sticker in approximately the same place on the back. Mark
in the diary that the sensor fell. If the patient is in the proximity of the
clinic, have the patient come to the clinic.
o Is the sticker intact and the sticker detached from the sensor?
If the sticker detached from the sensor have the patient try to reattach
it. In any case, the patient should come to the clinic to have it checked.
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Information for User
Figure 90: End of Procedure Flow Chart
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