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.

Appendix: Electrical Safety
Data Receiver
The data receiver records biomedical data sent by the capsule. It is worn by the
patient on a belt clip or a lanyard (around the neck). The data receiver features an
Event button that when pushed places a marker in the electronic data. A patient diary
for recording the time and reason for the event button use is stored on the backside of
the receiver. The data receiver weighs approximately 225g (0.5 lb).
Caution
Use only the SmartPill Docking Station (REF 50100400) to charge and download data from the receiver.
Figure 1
Featu
re
Description
A - Data Display
See Data Receiver Display Modes, Page 19 for more details.
B – Backlight Control
Button
The backlight button turns on a light, enabling the display to be read in low light
conditions. The backlight button is also us
ed to turn the data receiver off. The
backlight button and e
vent button (described below) must be simultaneously
depressed for 5 seconds to turn the data receiver off.
C – Event Button
The Event button turns the data receiver on. Patients press the event button when
engaging in an event (light exercise, eating, going to the bathroom, sleeping,
abdominal discomfort, pain, etc.) or experiencing any symptom which the clinician
believes may affect GI physiology and may be of interest. Pressing the
e
vent button
inserts a marker in the test data record.
D – Belt Clip and
Lanyard
The data receiver is equipped with a belt clip and supplied with a lanyard. The
patient has the choice of clipping the
data receiver on a waist belt or wearing the
data receiver suspended from a lanyard.
E – Patient Diary
The patient diary is to be used by the patient to record events, activities and
symptoms listed in the
patient instruction sheet, and the date and time the events
occurred. The entries in the
patient diary should correspond to the event button
markers inserted into the test data record when the event button is pressed.

Appendix: Electrical Safety
Docking Station
The docking station establishes electronic communication between the data receiver
and the system computer for data download and serves as a charging stand for the data
receiver. The docking station weighs approximately 200 grams (0.45 lbs).
Caution
Use only the Power Supply (REF 30100900) supplied with the SmartPill Docking Station.
Feature
Description
A
– LED Light
Indicates the state of data receiver. See table below.
B
– DC Power Connector
Provides a connection point for the power supply.
C
– USB Connector
Provides a connection point for the USB cable,
connecting the docking station to the system
computer.
Figure 2

Appendix: Electrical Safety
LE
D Color
State
Action Recommended
Red
Charging
Continue charging until the LED turns green.
Yellow
A charging circuit fault has
occurred
Undock and then re-dock the data receiver in the
docking station. If the yellow light persists
contact technical support.
Green
Fully charged
The data receiver is ready for use.
Off
xDocking station is not
connected to an AC power
source
xReceiver is not fully connected
to the docking station
xDocking station or data
receiver are in thermal
shutdown
xConnect the docking station to a source of
AC power.
xUndock and then re-
dock the data receiver in
the docking station.
xContact technical support for assistance.
Activation Fixture
The activation fixture turns the capsule on and off using strong magnets that interact
with the capsule’s internal power switch.
Warning
Individuals with pacemakers should not come within one (1) foot of the SmartPill activation fixture. The
fixture contains strong magnets that could interfere with pacemaker operation.
Warning
Do not store the SmartPill Activation Fixture in the same room with or a room adjacent to MRI equipment.
The fixture contains strong magnets and could become a dangerous projectile.
Caution
Keep the SmartPill Activation Fixture more than two (2) feet from magnetic media and computer monitors.
Caution
Do not store unused capsules within one (1) foot of the SmartPill Activation Fixture. Stray magnetic fields
from the activation fixture may activate the capsule.
System Computer and MotiliGI Software
MotiliGI software comes installed on the system computer. MotiliGI receives and
processes downloaded data from the data receiver, stores test data, provides data
analysis tools, and graphically displays test results. MotiliGI features algorithms that
calculate GET, SBTT, CTT, WGTT, and motility indices of the antrum and

Appendix: Electrical Safety
duodenum. An optical mouse is supplied with the system computer. An electronic
copy of this user manual is included in the software.
Caution
Use MotiliGI only on the system computer supplied with the SmartPill GI Monitoring System. Installing and
operating MotiliGI on another computer is not recommended or supported by SmartPill Corporation.
Caution
Do not use the vertical pipe (|) character in text fields or the software will remove it.
Minimum System Computer Requirements
Manufacturer
Operating System
Dell (preferred), IBM, HP, Toshiba
Any of the following 32-bit Microsoft Windows versions:
xXP Professional Service Pack 3 (recommended)
xWindows Vista Business
xWindows Vista Ultimate
xWindows 7 Professional (recommended)
xWindows 7 Ultimate
System does not work with 64-bit operating systems
Hard Drive
100 megabytes of available space for the MotiliGI application and 10
gigabytes of available space for test files (recommended)
Communication Port
1 open USB port
Peripherals
CD/RW Drive; printer is optional
Processor
Pentium IV 1 Gigahertz (GHz) or higher
Memory
1 gigabyte (GB) of RAM or
Display
1280 x 800 resolution
widescreen aspect ratio (recommended)
96 dpi
32-bit color
Other
Microsoft .NET Framework 1.1 SP 1
Adobe Acrobat 7.0.8 or later
Accessories
Your starter kit includes the acceosories below:
Accessory
Description
Starter Kit Backpack
A protective backpack that holds the system
components.
Belt Clips and Lanyards
Attach to the back of the data receiver.
User Manual
Complete the user training and read this manual
before running the SmartPill System. The user
manual contains important safety information.
USB Cable
Connects the docking station to the system computer.
Power Cord
Powers the docking station
Patient Instruction Sheets
Instruction sheets to send home with the patient
Power Adaptor (non US systems)
Modifies the power supply.

Appendix: Electrical Safety
Warning
Do not connect items to the SmartPill GI Monitoring System that are not part of the system.

Appendix: Electrical Safety
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Acronyms, Use, and Symbols
Acronyms
GET
Gastric emptying time
SBTT
Small bowel transit time
CTT
Colonic transit time
SLBTT
Combined small and large bowel transit
time
WGTT
Whole gut transit time
Intended Use/Indications for Use
The SmartPill GI Monitoring System measures whole gut and regional gut (stomach,
small bowel, and colon) transit times. Measurements of gastrointestinal (GI) tract
transit times are used for evaluating motility disorders.
The system measures pH, pressure, and temperature throughout the GI tract. Pressure
contraction data from the antrum and duodenum can be used to calculate motility
indices.
Suspected disease or
condition to evaluate
Indicated
M
easurement
Use
Gastroparesis
GET
Delayed gastric emptying is implicated
in such disorders as idiopathic and
diabetic gastroparesis and functional
non-ulcer dyspepsia.
Chronic
constipation
CTT
Aids in differentiating slow and normal
transit constipation.
SLBTT
A surrogate measure of colonic transit
in patients with chronic constipation
when CTT alone cannot be
determined.
Caution
Do not use in patients younger than 18 years old.
Contraindications for Use
Do not use in patients with these diseases or conditions:

Appendix: Electrical Safety
xhistory of gastric bezoar
xswallowing disorders
xsuspected or known strictures, fistulas, or physiological/mechanical GI
obstruction
xGI surgery within the past 3 months
xsevere dysphagia to food or pills
xCrohn’s disease or diverticulitis
ximplanted or portable electro-mechanical medical device such as a cardiac
pacemaker, defibrillator or infusion pump
xyounger than 18 years old.
Data transmission from the capsule to the data receiver is influenced by patient BMI.
Significant data dropout can occur in severely obese patients (>40 BMI).
Restricted Use
Caution
The SmartPill GI Monitoring System equipment is not suitable for use in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
Not for use with oxygen or oxygen-enriched atmospheres.
Storage
Store SmartPill GI Monitoring System components and capsules at ambient room
temperature (-15–40ºC) and humidity (rH 30–90%).
Caution
Do not expose the capsules to UV light. UV light can permanently damage the pH sensor.
Caution
Do not store capsules within 30cm (1 foot) of the activation fixture. The fixture’s magnetic field could
inadvertently activate the capsules.
Power Requirements
System Computer
110/220 VAC, 50–60 Hz
May require the use of a
power plug adapter
Docking Station
110/220 VAC, 50–60 Hz
May require the use of a
power plug adapter
Capsule
3.1 VDC self-contained
batteries
none
Data Receiver
8.4 VDC, self-contained,
none

Appendix: Electrical Safety
rechargeable batteries
Recycling and Disposal Instructions
xRecycle the data receiver and docking station following the local, regional, and
national regulations for electronic devices.
xThe capsule contains silver oxide batteries. Recycle unused capsules following the
local, regional and national regulations for electronic devices.
xDispose of used capsules following local, regional and national regulations for
disposing of human excrement.
xThe calibration buffer contains sodium citrate, a common food preservative.
Dispose of used buffer following local, regional, and national disposal regulations.
Device Markings
Caution, consult accompanying
documents
Consult directions for use
US FCC compliance
Prescription use only
Recycle. Dispose of properly
Single use only. Do not reuse
Part or catalog number
Manufacturer
Date of manufacture
Use by YYYY-MM
Lot number
Minimum and maximum storage
temperature
Caution: Strong magnet
Warning: Keep away from pacemakers

Appendix: Electrical Safety
BF
Type BF equipment
0123
CE marking and notified body number
Authorized representative
Sufficient for one test
IP57
Ingress protection rating
Serial number
Fragile
Keep dry
Data Receiver Display Messages
Looking for capsule—appears during test initiation before
the receiver receives
the first data packet from the capsule.
Locked onto capsule—appears after the data receiver
receives first data packet from the capsule.
Test in progress—appears when a test is in progress and
the data receiver is turned off and back on.
Data to download—appears when the data receiver stops
collecting data and has data to be downloaded.
Time
Capsule and data
receiver status icons /
[X] indicates a failure
Signal Strength
Pressure
pH
Indicates the data receiver is writing data from the capsule.
Indicates the event button is pushed.
The capsule’s data was received. / [X] indicates the data was not
received.

Appendix: Electrical Safety
The receiver’s battery life.
1 bar = 1 day of battery life.
3 bars = 3+ days.
Risks and Safety
Warning
This device does not differentiate between slow motility and functional outlet obstruction.
Non-Passage
Risks associated with capsule ingestion and transit are minimal. The primary hazard is
capsule retention. Retention incidence, as determined by a review of published studies
of capsule endoscopy in adults, is estimated as 0.75% in patients without known
stenosis and 21% in patients with known stenosis. Stenosis and strictures can be
complications in inflammatory bowel disease.
If you suspect a delay in passage and the Capsule is located in the stomach, a pro-
motility drug could be administered to assist in emptying the capsule from the
stomach. Alternatively, endoscopy could be performed in order to retrieve the capsule.
If located in the colon, laxative therapy could be administered to facilitate capsule
movement, or a colonoscopy could be performed in order to retrieve the capsule.
Adverse events reported in clinical studies involving the SmartPill are listed below.
Reported Adverse Events in Clinical Study Subjects (n=484)
Number of Events Reported
59
Number not related to the device
33
Number probably not related to the
device
17
Number possibly related to the device
5
Number definitely related to the device
4
Reported Adverse Events in Clinical Practice
In clinical practice since 2007, the company identified 25 events whose circumstances
suggested a potentially reportable event to regulatory authorities. After investigation
and follow up, seven of these events were deemed reportable including three instances
of esophageal retention, one gastric retention and three small bowel retentions.
Surgery was required for resolution in one instance of capsule small bowel retention
that led to identification of a stricture. A bowel prep resolved the second instance of
small bowel retention, and the third resolved with fluids and bed rest. Capsule
retention in the stomach was resolved endoscopically. Two of the retentions in the
esophagus were resolved endoscopically and in the third instance the patient vomited
and then performed a self-applied Heimlick maneuver to expel the capsule. There