Given Imaging SmartPill GI Monitoring System User manual

Appendix: Electrical Safety
SmartPill® GI Monitoring
System
User Manual
MotiliGI® v3.0
Doc: 111482-01
March 2013

Appendix: Electrical Safety
Copyrights
Text, graphics, logos and images in this manual are the property of Given Imaging and
protected by United States and international copyright laws. This Manual may not be
transferred or reproduced in any form without the written permission of Given
Imaging. Copyright © 2006-2012 Given Imaging. All Rights Reserved.
Trademarks
MotiliGI® and The Measure of GI Health® are registered trademarks, and
SmartPill™ and the SmartPill logo are trademarks of Given Imaging. Such marks are
protected by United States common law, federal and/or international trademark laws
and may not be used in violation of Given Imaging’s rights.
Patents
Certain uses and features of the products referenced herein are protected by one or
more United States and international patents or have pending patent applications.
Limited Warranties
The SmartPill GI Monitoring System
Given Imaging warrants the system* for a period of one (1) year from date of
purchase, and that the components of the system* have been designed, manufactured,
packaged and tested and, if properly used, are free from any defect of workmanship or
materials that would materially and adversely affect their intended use.
If any component of the system* fails during the period of this Limited Warranty for
reasons covered by this Limited Warranty, Given Imaging, at its option, shall replace
the specific failed component.
This Limited Warranty does not cover failure occurring in connection with or arising
out of uses not intended by Given Imaging, misuse, neglect, alteration, repair,
improper installation or improper testing. Without limiting the generality of the
foregoing statement, this Limited Warranty shall be invalidated if any repairs, services
or modifications are made to any of the components by any person not explicitly
authorized by Given Imaging.
Given Imaging is not liable or otherwise responsible for any loss, damage, or expense
arising, directly or indirectly, from the use of the system* or SmartPill capsule. Without
limiting the generality of the foregoing statement, customers are liable for all matters
beyond Given Imaging’s control such as handling, storage, cleaning, misuse, treatment
and diagnosis.

Appendix: Electrical Safety
This Limited Warranty is in lieu of and excludes all other warranties, whether
expressed or implied, including without limitation warranties of merchantability or
fitness.
Extended Warranty Options are available.
* Only the data receiver, docking station and activation fixture of the SmartPill GI
Monitoring System are covered by this Limited Warranty:
The SmartPill Capsule
Given Imaging warrants each Capsule is free from defects in workmanship and
materials until the Capsule’s labeled expiration date.
If Given Imaging verifies capsule failure during the warranty period for reasons
covered by the Limited Warranty, Given Imaging shall replace the failed capsule.
Additional Limitations
The Limited Warranty does not cover software or damages due to misuse, neglect,
alteration, repair, improper installation, set-up, calibration or improper testing.
Given Imaging is not liable for any incidental or consequential loss, damage, or
expense arising, directly or indirectly, from the use of the system or capsule.
Customers are liable for all matters beyond Given Imaging’s control such as handling,
storage, cleaning, misuse, treatment, and diagnosis.
This warranty is in lieu of and excludes all other warranties whether expressed or
implied warranties of merchantability or fitness.
The System Computer
The system computer is covered under the manufacturer’s warranty.
Rx Only
Given Imaging
3950 Shackleford Road, Suite 500 Duluth GA
30096 USA [email protected]
Given Imaging GmbH
Borsteler Chaussee 47 D-22453
Hamburg, Germany [email protected]
This device complies with Part 15 of the FCC. Operation is subject to the following two conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that may cause undesired
operation.

Appendix: Electrical Safety
Table of Contents
.............................................................................................................................................1
Introduction and Components...............................................................................................9
Using this Manual .................................................................................................................9
System Components...........................................................................................................10
SmartPill Capsule Pack ...................................................................................................10
Capsule Operational Specifications...............................................................................10
SmartBar...........................................................................................................................10
Data Receiver...................................................................................................................11
Docking Station...............................................................................................................12
Activation Fixture ...........................................................................................................13
System Computer and MotiliGI Software ...................................................................13
Accessories.......................................................................................................................14
Use and Care of the System..................................................................................................16
Acronyms, Use, and Symbols............................................................................................16
Acronyms .........................................................................................................................16
Intended Use/Indications for Use ...................................................................................16
Contraindications for Use ..............................................................................................16
Restricted Use..................................................................................................................17
Storage..................................................................................................................................17
Power Requirements.......................................................................................................17
Recycling and Disposal Instructions.............................................................................18
Device Markings .................................................................................................................18
Data Receiver Display Messages ...................................................................................19
Risks and Safety ..................................................................................................................20
Non-Passage ....................................................................................................................20
Patient-Contacting Materials..........................................................................................21
Care, Cleaning and Maintenance.......................................................................................21
Data Receiver...................................................................................................................21
Docking Station...............................................................................................................22
Troubleshooting and Support...........................................................................................22
Setting-Up the System ...........................................................................................................23
Getting Started ....................................................................................................................23

Appendix: Electrical Safety
Setting up the Computer................................................................................................ 23
Preparing for a Test...............................................................................................................25
Before the Test Day...........................................................................................................25
Charging the Data Receiver........................................................................................... 25
Preparing the Patient......................................................................................................26
During the Office Visit .................................................................................................. 27
Starting a Test.........................................................................................................................30
Preparing the System .........................................................................................................30
Performing the Test – Test Initiation Wizard ................................................................30
Step 1: Connect the Data Receiver...............................................................................30
Step 2: Enter Patient Information ................................................................................31
Creating Templates:........................................................................................................ 33
Using Templates .............................................................................................................33
Step 3: Assemble Materials ............................................................................................34
Step 4: Activate Capsule.................................................................................................35
Step 5: Select Capsule.....................................................................................................36
Step 6: Enter Pressure Calibration Code ..................................................................... 38
Step 7: Add pH Calibration Buffer...............................................................................38
Step 8: Capsule pH Calibration.....................................................................................39
Step 9: Ingestion..............................................................................................................40
Step 10: Complete Discharge Checklist.......................................................................42
Live Monitoring Mode (optional) ....................................................................................43
Aborting a Test – Deactivating the Capsule ...................................................................44
Ending a Test .........................................................................................................................45
Returning the Data Receiver............................................................................................. 45
Downloading a Test...........................................................................................................45
Post Test Notes...............................................................................................................46
Confirming Capsule Exit ............................................................................................... 47
Analyzing the Test .................................................................................................................48
Introduction to the Test Analysis Wizard.......................................................................48
Analyzing the Test..............................................................................................................50
Patient Diary Events.......................................................................................................50
Select Capsule Ingestion ................................................................................................51

Appendix: Electrical Safety
Gastric Acidity.................................................................................................................52
Procedure Deviation – Additional Meal Before 6 Hours ..........................................53
Select Gastric Emptying.................................................................................................55
Magnitude of pH Rise at Emptying..............................................................................56
Gastric Pressure Characteristics ....................................................................................57
Small Bowel pH profile ..................................................................................................57
Small Bowel Pressure Characteristics ...........................................................................58
Select Ileo-Cecal Junction ..............................................................................................59
Colonic Pressure Characteristics ...................................................................................60
Warning: Data Collected During Capsule Low Voltage ............................................61
Select Body Exit ..............................................................................................................62
Review Your Physiological Markers with MotiliGI’s Markers......................................64
MotiliGI-Computed Capsule Ingestion........................................................................65
MotiliGI-Computed Gastric Emptying........................................................................66
Absence of Gastric Emptying .......................................................................................67
Gastric Emptying Statistics............................................................................................68
Gastric Emptying Time Evaluation ..............................................................................69
MotiliGI-Computed ICJ.................................................................................................70
Small Bowel Transit Time Evaluation..........................................................................71
MotiliGI-Computed Body Exit.....................................................................................72
Absence of Body Exit.....................................................................................................73
Colonic Transit Time Evaluation..................................................................................74
Test Analysis Review ......................................................................................................74
Reading Test Summary Reports........................................................................................75
Transit Data Tab .............................................................................................................76
Descriptive Data Tab......................................................................................................77
Interpretations Tab .........................................................................................................78
Properties Tab .................................................................................................................79
Examples of Physiological Markers..................................................................................79
Ingestion...........................................................................................................................79
Gastric Emptying ............................................................................................................80
ICJ .....................................................................................................................................81
Body Exit Time ...............................................................................................................81

Appendix: Electrical Safety
MotiliGI Features...................................................................................................................83
MotiliGI User Interface..................................................................................................... 83
Titlebar .............................................................................................................................83
Main Menus..................................................................................................................... 83
Toolbar Icons..................................................................................................................83
Graph Area ......................................................................................................................85
Data Panels ......................................................................................................................85
Time Slider Control........................................................................................................85
Display Tabs....................................................................................................................85
Status Bar .........................................................................................................................85
MotiliGI Keyboard Shortcuts ....................................................................................... 86
Opening a Test by the Patient’s Name ........................................................................86
Opening a Test by the File Name.................................................................................87
Closing a Test..................................................................................................................87
Exiting MotiliGI..............................................................................................................88
Setting General User Preferences..................................................................................... 88
General Tab.....................................................................................................................88
Graph Tab .......................................................................................................................89
Report Tab....................................................................................................................... 90
Creating Report Letterhead ...........................................................................................91
Files Tab...........................................................................................................................92
Setting Preferences Back to Default.............................................................................92
Editing Patient Information.............................................................................................. 92
Changing the Graph Display ............................................................................................93
Selecting Data Plots........................................................................................................ 93
Changing the Test View................................................................................................. 94
Changing Axis Scales......................................................................................................96
Analyzing Data ................................................................................................................... 97
Showing and Hiding Annotations ................................................................................97
Editing Patient Diary Events.........................................................................................97
Creating New Event Annotations ................................................................................ 98
Editing Event Annotations............................................................................................98
Adding or Changing the Location of Physiological Markers ....................................99

Appendix: Electrical Safety
Viewing Transit Times..................................................................................................100
Calculating Statistics......................................................................................................100
Creating Output ................................................................................................................101
Generating a Report......................................................................................................101
Exporting Data to Excel ..............................................................................................102
Exporting Images to JPEG or GIF............................................................................104
System Administrator Tools ...............................................................................................105
Password Management ....................................................................................................105
Logging into the System Computer............................................................................105
Logging into MotiliGI ..................................................................................................106
MotiliGI Security ..............................................................................................................106
Security Tab ...................................................................................................................106
Backing Up Patient Files ..............................................................................................107
Installing Software ............................................................................................................108
MotiliGI Administrator ................................................................................................108
Installing Software from a CD ....................................................................................109
Installing Software from a File on the System Computer Hard Drive...................109
Uninstalling MotiliGI....................................................................................................110
Installing MotiliGI.........................................................................................................110
Appendix: Electrical Safety .................................................................................................112
Index...................................................................................................................................116
Contacting Given Imaging ..............................................................................................119

Appendix: Electrical Safety
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Using this Manual
Complete user training and read this manual before running the SmartPill
System. This manual contains important safety information and
contraindications.
This manual makes use of 2 special notations: Warning and Caution, the meanings of
which are:
Warning
Potentially hazardous situations which could result in serious adverse reactions (death or serious injury) or
serious safety hazards to users and patients. All warnings are boxed.
Caution
Potentially hazardous situations which could result in minor or moderate injury or damage to the equipment
or other property.

Appendix: Electrical Safety
System Components
SmartPill Capsule Pack
Each capsule pack contains a single-use capsule, calibration buffer, instructions for use
and a patient diary.
The capsule measures pressure, pH, and temperature to determine transit times of the
stomach, small bowel, and colon. Transit times derived by capsule motility procedures
provide alternatives to other tests such as gastric emptying scintigraphy, whole gut
scintigraphy, and radio-opaque markers.
Caution
Do not use a SmartPill capsule if it has been dropped as this may affect function.
Capsule Operational Specifications
Attribute
Specification
Pressure Accuracy
0-99 mmHg ± 5 mmHg
100-350 mmHg ± 10% of applied pressure
Pressure Range
0-350 mmHg
pH Accuracy
± 0.5 pH units
pH Range
1–9 pH units
Temperature Accuracy
± 1°C (between 20 – 42ºC)
Transmission Frequency
434.2 MHz (radiating between 426 – 445 MHz)
Battery Life
Capsule and Data Receiver, >5 days
Weight
4.5 grams
Size
26 x 13mm
SmartBar
The SmartBar is a standardized meal that is ingested immediately before capsule
ingestion. To accurately measure gastric emptying patients must consume a standard
meal immediately before ingesting the capsule.