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 [e-mail]

Given Imaging GmbH

Borsteler Chaussee 47 D-22453
Hamburg, Germany [e-mail]

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.

Table of Contents

Appendix: Electrical Safety

............................................................................................................................................. 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

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

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

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

Featu

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.

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

re

Appendix: Electrical Safety

Feature

Description

A

Indicates the state of data receiver. See table below.

B

Provides a connection point for the power supply.

C

Provides a connection point for the USB cable,

computer.

Figure 2

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.

– LED Light
– DC Power Connector
– USB Connector

connecting the docking station to the system

Appendix: Electrical Safety

LE

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

x Docking station is not

shutdown

x Connect the docking station to a source of

dock the data receiver in

D Color

connected to an AC power
source

x Receiver is not fully connected

to the docking station

x Docking station or data

receiver are in thermal

Activation Fixture

AC power.

x Undock and then re-

the docking station.

x Contact technical support for assistance.

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

Manufacturer

Dell (preferred), IBM, HP, Toshiba

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

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.

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

Operating System

Any of the following 32-bit Microsoft Windows versions:

x XP Professional Service Pack 3 (recommended)

x Windows Vista Business

x Windows Vista Ultimate

x Windows 7 Professional (recommended)

x Windows 7 Ultimate

Accessories

Your starter kit includes the acceosories below:

Appendix: Electrical Safety

Warning

Do not connect items to the SmartPill GI Monitoring System that are not part of the system.

Appendix: Electrical Safety

GET

Gastric emptying time

SBTT

Small bowel transit time

CTT

Colonic transit time

SLBTT

Combined small and large bowel transit
WGTT

Whole gut transit time

Suspected disease or
condition to evaluate

Indicated
M

Use

Gastroparesis

GET

Delayed gastric emptying is implicated
in such disorders as idiopathic and
diabetic gastroparesis and functional
non-ulcer dyspepsia.

Chronic

CTT

Aids in differentiating slow and normal

SLBTT

A surrogate measure of colonic transit

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Acronyms, Use, and Symbols

Acronyms

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.

constipation

easurement

transit constipation.

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

System Computer

110/220 VAC, 50–60 Hz

May require the use of a

Docking Station

110/220 VAC, 50–60 Hz

May require the use of a

Capsule

3.1 VDC self-contained

none
Data Receiver

8.4 VDC, self-contained,

none

x history of gastric bezoar

x swallowing disorders

x suspected or known strictures, fistulas, or physiological/mechanical GI

obstruction

x GI surgery within the past 3 months

x severe dysphagia to food or pills

x Crohn’s disease or diverticulitis

x implanted or portable electro-mechanical medical device such as a cardiac

pacemaker, defibrillator or infusion pump

x younger 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

power plug adapter

power plug adapter

batteries

Appendix: Electrical Safety

rechargeable batteries

Caution, consult accompanying
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
Caution: Strong magnet

Warning: Keep away from pacemakers

Recycling and Disposal Instructions

x Recycle the data receiver and docking station following the local, regional, and

national regulations for electronic devices.

x The capsule contains silver oxide batteries. Recycle unused capsules following the

local, regional and national regulations for electronic devices.

x Dispose of used capsules following local, regional and national regulations for

disposing of human excrement.

x The calibration buffer contains sodium citrate, a common food preservative.

Dispose of used buffer following local, regional, and national disposal regulations.

Device Markings

documents

temperature

BF

Type BF equipment

CE marking and notified body number

Authorized representative

Sufficient for one test
IP57

Ingress protection rating

Serial number

Fragile

Keep dry

Looking for capsule—appears during test initiation before

the first data packet from the capsule.

Locked onto capsule—appears after the data receiver

Test in progress—appears when a test is in progress and

Data to download—appears when the data receiver stops
collecting data and has data to be downloaded.

Capsule and data
receiver status icons /
[X] indicates a failure

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.

0123

Data Receiver Display Messages

Appendix: Electrical Safety

Time

the receiver receives

receives first data packet from the capsule.

the data receiver is turned off and back on.

Signal Strength

Appendix: Electrical Safety

The receiver’s battery life.

3 bars = 3+ days.

Number of Events Reported

59

Number not related to the device

33

Number probably not related to the

17
Number possibly related to the device

5

Number definitely related to the device

4

1 bar = 1 day of battery life.

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 pro­motility 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)

device

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

Appendix: Electrical Safety

was one additional esophageal retention, eight gastric retentions, four small bowel
retentions and five colonic retentions. These resolved either without intervention or
with endoscopy/colonoscopy.

Patient-Contacting Materials

Patient-contacting materials include polyurethane, a polyurethane-polycarbonate blend,
Teflon coated with polyhema, an ISFET pH sensor, epoxy and UV-cured adhesive.

All patient contacting materials have been tested for biocompatibility and have been
found non-toxic, non-sensitizing, and non-irritating.

The device does not contain natural rubber latex.

Care, Cleaning and Maintenance

Caution

Do not reuse capsules. The capsule is a single-use, disposable item.

Caution

Do not immerse the data receiver in water or other liquids. Immersion damages internal electrical components
resulting in data receiver inoperability.

Caution

Do not immerse the docking station in water or other liquids. Immersion damages internal electrical
components and could result in electrical shock.

Caution

The data receiver, docking station, power supply, and capsule are not user serviceable.

Data Receiver

Clean and disinfect the outside surfaces of the data receiver after each patient use.

1. Turn off data receiver by simultaneously depressing the backlight button and event
button for 5 seconds.

2. Wipe outside surfaces with a cloth dampened (not saturated) with a mild detergent
and water. Suitable detergents include dishwashing detergent (e.g., Joy, Dawn®,
Palmolive®) solutions, or laboratory glassware cleaners such as Alconox®.

3. Wipe dry.

4. Disinfect by wiping outside surfaces with a cloth dampened (not saturated) with
disinfectant. A solution of 10% household bleach can be used as a disinfectant.

5. Wipe dry.

6. Wait at least 5 minutes after cleaning and disinfection before turning the data
receiver on or placing it in the docking station.

7. Conduct a preventive maintenance inspection. Check for cracks or damage. Shake
the data receiver and listen for detached batteries. Do not use the data receiver if
the case is cracked or damaged, or a rattling can be heard.

Appendix: Electrical Safety

Caution

Do not attempt to replace batteries in the data receiver.

Docking Station

1. Unplug docking station from the power supply.

2. Dust the surfaces of the docking station with a soft, dry cloth. Do not use water or
liquids.

3. Clean the gold connector pins with a swab and Isopropyl alcohol.

4. Conduct a preventive maintenance inspection. Check for cracks or damage. Do not
use the docking station if the case is cracked or damaged.

Caution

Do not use the components of the system with any other equipment.

Troubleshooting and Support

Contact technical support if you have a problem setting up or operating the system:

For swift and direct support, please be prepared to answer the following questions:

x What version of MotiliGI are you using? To determine what version you are

using:

x Select Help > About.

x Refer to the version printed on the MotiliGI CD.

x What operation or steps did you take before the problem occurred?

x What operations or steps did you take after the problem occurred?

x What is the exact error message that appeared?

x If you have trouble with a capsule or other hardware component, have the

component’s lot and serial numbers ready. These numbers are on labels affixed
to the hardware component or packaging.

Appendix: Electrical Safety

User Name

Password

sgims1

12345

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Getting Started

1. Remove the data receiver, docking station, activation fixture, USB cable, power
adapter, and power cord from the starter kit case.

2. Unpack the system computer and power supply from its shipping container.

► Connect the computer to a source of AC power.

Setting up the Computer

1. To login to the System Computer, enter the information below.

2. Ensure the system computer has the correct date, time, language and regional
settings.

Changing the System Computer Date, Time, Language and Regional Options

1. Select Start > Control Panel > Clock, Region and Language

2. Change the desired settings.

► Changing certain settings may require you to reboot the system computer.

Launching MotiliGI (for the first time)

1. Open the MotiliGI software:

x Click on the desktop.

x Select Start > All Programs > SmartPill folder > MotiliGI.

2. When launching MotiliGI for the first time, the MotiliGI License Agreement will

appear. Review and click I Agree. You must accept the terms and conditions in

order to run MotiliGI.

3. The MotiliGI Configuration appears. Enter an identification number or word (e.g.
001 or Main Office) to identify SmartPill tests run at your particular office.

x If your institution or practice has more than one office, you may wish to use

this feature to identify at which office a specific test was conducted.

Appendix: Electrical Safety

4. Click OK. You will be asked to confirm the clinic identification number you
entered; click Yes to proceed to the First Login Sequence screen.

5. Click OK. The administrator user login screen appears.

6. Create a username and password for the administrator account for MotiliGI. The
username and password must contain a minimum of 5 alphanumeric characters.

7. Verify the password by re-entering it, and click Login. You will be required to
enter this username and password each time you start the program. The MotiliGI
Start-Up screen appears.

Connecting the Docking Station to the System Computer

1. Connect the docking station to an AC power source using the power cord.

2. Connect the docking station to the system computer using the USB cable.

3. Turn the data receiver on by depressing the event button.

4. Dock the data receiver by placing it in the docking station cradle. Push down on
the top of the data receiver to ensure the data receiver is fully docked.

5. Confirm the system computer and docking station are communicating by noting

the presence of the data receiver connected icon in the MotiliGI status bar (the
horizontal bar at the bottom of the MotiliGI user interface).

x If you observe the receiver communication disabled and test state unknown

icons, either the docking station is not properly connected to the system

computer, or the data receiver is not fully docked.

► Reseat the data receiver in the docking station and ensure the docking station is

connected to both the computer and a power supply. The test state unknown icon will
disappear once the connection is established. If it does not disappear, contact Technical
Support for assistance.

6. Before starting a test, fully charge the Data Receiver. See Chapter 4: Charging the
Data Receiver for instructions.

Appendix: Electrical Safety

3UHSDULQJIRUD7HVW

Before the Test Day

Fully charge the data receiver the day or night before starting a test. Charging can take
up to 5 hours.

Charging the Data Receiver

1. Ensure that the data receiver is off. If any characters appear on the display, turn off
the data receiver by simultaneously pressing the 2 buttons on the front of the unit
for approximately 5 seconds.

Caution

The data receiver must be turned off during charging. Charging the data receiver while turned on results in a
partial charge. You may lose test data.

2. When the back light dims, release both buttons.

3. Plug the docking station into an electrical outlet.

► If necessary, use a power adapter.

4. Firmly push the data receiver into the docking station to initiate charging. The
docking station’s LED turns red.

Figure 3

x Allow up to 5 hours for the data receiver to fully charge.

x The docking station’s LED turns green when the data receiver is fully charged.

Caution

Charging or recharging the data receiver with a power source other than the SmartPill power supply may
permanently damage the data receiver, docking station, or system computer and will void the product
warranty.

Appendix: Electrical Safety

Schedule

Restriction

24 hours before the test

Do not consume alcohol.

8 hours before the start of the test

Do not eat or drink.

Do not use tobacco.

6 hours after the start of the test

Do not use tobacco.

Do not eat.

Do not sleep.

Do not consume alcohol.

Schedule

Type

Examples

7 days before the tests

Proton pump inhibitors

Omeprazole,
Lansoprazole, Nexium

48 Hours

Histamine2 blockers

Zantac

48 Hours

Motility-altering
medications

Cisapride,
D

omperidone,

M

etoclopramide

(Reglan)

48 Hours

Antiemetics & 5HT3
anatagonists

Zofran, Kytril

48 Hours

Macrolides

Erythromycin,
Z

ithromycin

48 Hours

Anticholinergics

Phenergan, Compazine

48 Hours

5HT4 partial agonists

Zelnorm

24 Hours

Antacids

Maalox, Mylanta,

Preparing the Patient

Before the Office Visit

1. Review these requirements and restrictions with the patient. The test requires
fasting for accurate results.

2. Review the use of medications with the patient. Stop medications that alter motility
or gastric pH. Examples of medications are provided below.

x Unless the patient is well stabilized (condition and dose has been stable for 3

months or more), discontinue these medications prior to the start of the test.

Appendix: Electrical Safety

Rolaids

SmartBar

Granola (Rolled Oats, Evaporated Cane Juice, Expeller Pressed Canola Oil,

Flavor, Soy Lecithin), Whey Crisp, Rice Syrup, Corn Syrup, Whey Protein Isolate,

etable Oil (Cottonseed, Soybean), Honey,

Natural and Artificial Flavor, Salt, Vanilla.

Nutritional
Composition

66% carbohydrate

3% fiber
(in % of weight)

17% protein

243 kcal

2% fat

Ingredients

½ cup (120 g) Egg Beaters®,
equivalent to the volume of 2 large
egg whites; 60 kcal

2 slices of bread; 120 kcal

1.5 Tbsp. (30 g) strawberry jam; 75
kcal

½ cup (120 ml) water

Sche

dule

Restriction

6 hours after ingesting the
capsule

x Do not eat.

x Do not take medication.

x Insulin-dependent diabetic patients must take half of their normal morning dose

of insulin and monitor glucose levels according to normal routines.

3. Review SmartBar ingredients and rule out any food allergies.

x The SmartBar contains a small amount of gluten.

x The SmartBar does not contain lactose.

x The SmartBar does not contain nuts but is manufactured in a plant that

processes nuts.

Ingredients

Defatted Wheat Germ, Oat Flour, Brown Rice Syrup, Molasses, Salt, Natural

Invert Sugar, Puffed Wheat, Apples, Maltodextrin, Sorbitol, Apple Juice
Concentrate, Partially Hydrogenated Veg

If necessary, an egg based meal can be substituted for SmartBar. You must have a
microwave to prepare this meal.

Caution

To accurately measure regional gut transit times the patient must consume either SmartBar or the egg based

meal immediately before ingesting the capsule.

During the Office Visit

1. Ensure the patient has adhered to restrictions required before the test.

2. Provide printed instructions (included in starter kit) to the patient. Additional
copies can be purchased.

3. Review the schedule, restrictions, and use of medications with the patient. Inform
the patient that failure to follow these instructions may invalidate the test.

Appendix: Electrical Safety

x Do not use tobacco.

During the entire test

x Do not consume alcohol.

x

If you are diabetic, monitor glucose levels and follow your personal
treatment plan. If you are un

sure, contact the doctor who manages your

diabetes.

x

Avoid vigorous exercise such as sit-ups, abdominal crunches, and
prolonged aerobic activity (greater than 15 minutes).

x

Do not wear the data receiver while bathing or showering.

x

Do not use laxatives, bowel cathartics, anti-

diarrhea medications, alcohol
and other drugs or medications that affect motility until after the capsule
passes.

eating a meal
getting up in the morning; going to bed at night
cramping or pain

nausea
passing gas
vigorous exercise or activity

4. Instruct the patient to keep the receiver as close to the abdomen as possible except
while bathing or showering:

x Positioned on a belt

x Suspended by a lanyard

Caution

Instruct patients not to use the lanyard when sleeping

Caution

Eating anything (except limited quantities of water) before the capsule has emptied will delay gastric emptying
of the test meal and invalidate results.

5. Instruct the patient on the use of the patient diary and the data
receiver’s event button. Every time the patient presses event, the
patient must record the time displayed on the data receiver and a brief
description of the event or activity in the diary.

► Patients must press event for all bowel movements.

Pressing event:

x Marks bowel movements which are useful for verifying capsule exit.

x Marks other events and symptoms which may be useful when reviewing test

data.

x Adds an event marker to the electronic data record.

Other events and symptoms you may ask the patient to mark and enter in the
patient diary include:

Resumption of Normal Routine

6. Review these instructions and warnings with the patient.

Appendix: Electrical Safety

x Patients may resume a normal diet 6 hours after swallowing the capsule.

x Except for restrictions noted on the Patient Instructions Sheets, patients may

resume normal activities when released from your office.

Warning

Magnetic Resonance Imaging (MRI) must not be performed on a patient who has ingested the capsule until
capsule passage is confirmed by the physician’s review of the MotiliGI graph or abdominal x-ray. An MRI test
performed with an ingested capsule may result in damage to the GI tract.

Warning

Instruct the patient to contact your office if he or she experiences acute pain, sudden nausea, or vomiting
beyond his or her typical pattern within 5 days of ingesting the capsule as these symptoms could indicate
bowel obstruction.

Scheduling a Follow-up Office Visit

7. Schedule a visit to return the data receiver 4-5 days (96-120 hours) from the start of
the test.

Appendix: Electrical Safety

Component

Success

Troubleshooting

Docking station’s

Green

x Red

:

Technical Support.

Data receiver

The “Looking For

essage

appears.

x LCD is blank

System

x 2 beeps

appear in the

corner of the

x

x No beeps

the docking

The charge is insufficient for a 5-day test.

6WDUWLQJD7HVW

Preparing the System

Perform these steps immediately before or after a patient’s arrival at the office.

1. Turn on the system computer.

2. Open MotiliGI:

x Click on the desktop.

x Select Start > All Programs > SmartPill > MotiliGI.

3. If prompted, enter a username and password. Click OK. The main startup screen
appears.

Performing the Test ± Test Initiation Wizard

Step 1: Connect the Data Receiver

Caution

Do not close MotiliGI while operating the Test Initiation Wizard because data can be lost. Complete or
cancel the Wizard first.

Caution

You may cancel the wizard any time. However, a capsule exposed to the pH calibration buffer must be
ingested within 2 hours or discarded.

1. Follow the prompts. Check the results:

LED

display

Computer

Capsule” m

x These icons

lower-right

screen:

The data receiver may not be fully charged. See Chapter 4
Charging the Data Receiver.

x Yellow

Undock and re-dock the data receiver in the docking
station. If the yellow light persists, contact SmartPill

Turn on the data receiver by pressing the event button.

x Check the computer’s sound level.

x Undock and re-dock the data receiver in

station. If there are still no beeps, contact Technical
Support.

x The “Receiver is Not Fully Charged” message appears.

Appendix: Electrical Safety

x Replace the data receiver with a fully charged receiver.

receiver.

x

x Allow additional charging time for the current

The data receiver must be turned off during charging. Charging the data receiver while
turned on results in a partial charge. You may lose test data.

2. Click Next >.

Step 2: Enter Patient Information

Patient information becomes a permanent part of the patient’s MotiliGI record.

General Tab

*indicates a required field

1. Enter the required information.

Contraindications Tab

You must view this screen.

2. Complete the applicable fields.

Appendix: Electrical Safety

Depending on your selections, other screens may appear. For example, an override
screen for a contraindication or caution may appear.

x (Optional) Enter notes and click Physician Ok.

x (Optional) Click End Test.

3. Proceed to the optional tabs below or click Next >.

Optional Tabs: Prior GI Procedures, Allergies and Medications, Symptoms

Entering information in these tabs is optional. The symptoms tab includes a selection
of ICD9 and ICD10 codes.

Appendix: Electrical Safety

Creating Templates:

To save time you can create text descriptions that are saved in MotiliGI. These text
templates can be reused from patient to patient. Text descriptions saved this way are
called templates. We recommend creating general templates with blank lines to
indicate where patient specific information can be inserted.

1. Click Create Template.

a. Enter a title for the prior abdominal surgery or implanted device. Examples:

x Appendectomy

x Gastric stimulator

b. (Optional) Click in the text field under the title. Enter descriptive details. Examples:

x Date:______________

x Name of the surgeon:___________________

2. Click Save Template.

Using Templates

1. Click for saved templates.

2. Select a template. Insert any patient specific information.

3. Click → to move information to the patient record.

► (Optional) To remove information from the patient’s record, select it and click Remove Entry.

Appendix: Electrical Safety

The templates remains in the Template list. To delete the selection, click Delete
Template.

Step 3: Assemble Materials

1. Follow the prompts.

x The capsule’s instructions for use are in the inside pocket of the capsule pack.

2. Click Next >.

Step 4: Activate Capsule

Appendix: Electrical Safety

1. Follow the prompts.

2.

Figure 4 - Capsule Activation Window

Caution

Once the capsule is activated, keep the capsule at least one (1) foot away from the activation fixture. If the
capsule is kept near the activation fixture, stray magnetic fields from the activation fixture may deactivate the
capsule.

3. Confirm the capsule has activated:

x Observe the data receiver’s display for at least 1 minute. The message “Locked

onto Capsule” and the capsule’s serial number will appear on the data receiver
for approximately 4 seconds.

Appendix: Electrical Safety

Capsule Serial
number

SS = signal strength

P = pressure

X] = The data was not

received.

x The data receiver’s display then indicates the capsule’s data:

The capsule’s data was received. / [

x The icon appears in the lower-right corner of MotiliGI: .

► If the capsule did not activate, repeat the procedure.

4. Click Next >.

5. If you wish to deactivate the test, see Aborting a Test – Deactivating the Capsule,
Page 44.

Step 5: Select Capsule

All activated capsules (ingested or not yet ingested) within range of the data receiver

1

appear

. This process may take up to 1 minute.

1

The data receiver can detect the capsule in open air (not ingested) at distances of up to 40 feet.

Appendix: Electrical Safety

Capsule and data
receiver status icons /
[X] indicates a failure

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] = The data was not received.

The receiver’s battery life.

3 bars = 3+ days.

1. To select the capsule you activated, click the row that matches the capsule
container’s serial number. An arrow indicates your selection.

x If the software does not detect the capsule within a minute, observe the data

receiver’s display to confirm the capsule is active.

x If the capsule is activated the data receiver displays this data during a test.

Time

Signal Strength

1 bar = 1 day of battery life.

2. Click Next >.

Appendix: Electrical Safety

Step 6: Enter Pressure Calibration Code

1. Locate the calibration code found on the lid of the capsule container. Enter the
code.

2. Click Next >.

Step 7: Add pH Calibration Buffer

Caution

Once exposed to buffer, the capsule must be ingested within 2 hours or discarded. Confirm that the patient is

available and prepared to proceed with the test before you begin Step 7.

1. Put gloves on and follow the prompts.

Caution

Wear gloves when handling the capsule. Do not touch the calibration buffer or capsule with your finger as
this could cause an electrostatic charge.

Appendix: Electrical Safety

A

B

C

A

B

C

Caution

The orientation of the capsule in the capsule container is important. When reinserting the capsule, ensure
the pH sensor is in the same orientation relative to the diamond-shaped window of the capsule container.

Figure 5 - Capsule Orientation

– Capsule pH sensor
– Buffer filling channel
– Diamond shaped window

Do not discard the capsule container’s cover. The cover contains information that is
needed if the test cannot take place as planned or assistance from Technical Support is
required.

2. Click Next >.

Step 8: Capsule pH Calibration

No action is necessary. The software checks the status of the capsule and data receiver
during this step.

Appendix: Electrical Safety

x Calibration normally takes less than 3 minutes, but may take up to 15 minutes.

x During calibration, it is normal for fluctuations in the pH value to occur.

Calibration is complete when all these signals appear:

x The pH value stabilizes at 6.0.

x The “pH Calibration Complete” message appears.

x The MotiliGI status bar icon indicates the capsule is ready for use and the

data receiver is recording information from the capsule.

If the capsule does not calibrate within 15 minutes, this message appears: “pH
Calibration Timeout.”

1. Ensure the capsule is immersed in buffer.

2. Click Back.

3. Click Next. The calibration process reinitiates.

x If the calibration fails after 2 attempts contact Technical Support.

Step 9: Ingestion

1. Follow the prompts. Record the time of completion in the patient diary.

Caution

The meal must be eaten immediately before capsule ingestion.

Appendix: Electrical Safety

Caution

To avoid loss of data during Step 9.2, avoid separating the capsule and data receiver by more than 5 feet.

The data receiver records biomedical data from within the patient’s GI tract. Every
few seconds, the pH and pressure readings update on the data receiver’s display.

► Dispose of the pH calibration buffer following all applicable regulations. The buffer is a solution

of sodium citrate pH 6.0.

2. Click Next >.

Step 10: Complete Discharge Checklist

Appendix: Electrical Safety

1. Review the discharge checklist with the patient. Instruct the patient to wait 3
minutes in the bathroom before flushing the toilet after each bowel movement.
Explain that to confirm body exit, the patient must let the capsule communicate
with the data receiver after bowel movements.

2. Review these warnings:

Warning

Magnetic resonance imaging (MRI) must not be performed on a patient who has ingested the capsule until
capsule passage is confirmed by physician review of the MotiliGI graph or abdominal x-ray. An MRI test
performed with an ingested capsule may result in damage to the GI tract.

Warning

Instruct the patient to contact your office if he or she experiences acute pain, sudden nausea, or vomiting
beyond his or her typical pattern within 5 days of ingesting the capsule as these symptoms could indicate
bowel obstruction.

Warning

If you suspect bowel obstruction, treat consistent with your management of a foreign object causing
obstruction. Consider an abdominal x-ray to determine if the capsule is retained and its location within the
GI tract.

3. Schedule an appointment for the patient to return the data receiver.

The capsule typically passes naturally within 2–5 days after ingestion depending
upon the patient’s condition.

Appendix: Electrical Safety

Indication for Use

Return Data Receiver After

Measuring GET

24-48 hours

Measuring WGTT

2–5 days

Guidelines:

4. Check the box I have completed the patient’s discharge.

5. Click Finish. The Patient Information screen appears.

6. Do any of the following:

x Enter notes regarding the patient’s capsule ingestion.

x Close MotiliGI.

x Use Live Monitoring mode to view live data while the patient is still in the

office.

Live Monitoring Mode (optional)

You may view live data from the capsule while the patient is still in the office.

Prerequisites:

x The test has begun.

x The docking station is connected to the system computer.

x The data receiver is in the docking station.

1. Click or select Action > Live Monitoring. The Live Monitoring control panels
appears on the right.

It may take several minutes for sufficient data to be captured before the MotiliGI
graph begins to show a noticeable progression of pressure, pH, and temperature data
values.

Caution

The patient must remain in close proximity of the docked data receiver during live monitoring. If the patient
moves away from the data receiver, test data may be permanently lost.

x You may remove the data receiver from the docking station at any time during

live monitoring without data loss if the data receiver is kept near the patient
during the transition from being docked to being worn by the patient. When
you remove the data receiver from the docking station, live monitoring stops.

x The MotiliGI software cannot save test data displayed during live monitoring,

2. To exit live monitoring, click Stop on the live monitoring control panel.

but the data are stored on the data receiver and are downloaded as part of the
completed test.

Appendix: Electrical Safety

Aborting a Test ± Deactivating the Capsule

Caution

If a test is aborted before the capsule has been exposed to buffer solution, the capsule may be deactivated but
must be used within two (2) hours or discarded.

Caution

If a test is aborted before ingestion and the capsule has not been exposed to buffer solution, the capsule may
be deactivated but must be used within one month or before its expiration date is reached, whichever is
sooner. Otherwise discard the capsule (refer to Recycling and Disposal Instructions, page 18).

1. Place the capsule’s container onto the activation fixture.

2. Align the diamond-shaped window on the capsule’s container with the Off mark
on the activation fixture.

3. Leave the capsule container in place for 5 seconds and then lift straight up and off
the activation fixture.

4. Confirm the capsule is deactivated:

x Place the capsule container in the docking station’s well and observe the data

receiver’s display. The capsule is off if this icon (lower right) is replaced with
an X. The X may take 1-2 minutes to appear.

Appendix: Electrical Safety

(QGLQJD7HVW

To determine capsule exit, you can observe the data display on the data receiver for at
least 2 minutes. If the data receiver is receiving data from the capsule, this icon

appears every 20–40 seconds, which confirms that the capsule is still in the patient. No
evidence of the icon within the 2-minute observation is presumptive evidence of
capsule exit. Actual passage can only be confirmed clinically by examination of the
graph or physical examination.

Returning the Data Receiver

Following the test, the patient returns the data receiver and patient diary to your office.
A nurse or medical technician can perform these steps.

1. Collect the data receiver.

2. Ask the patient about his or her experience with the SmartPill test. Use MotiliGI’s
Post-Test Notes screen for recording information:

x Did the patient experience any unusual cramping, pain or discomfort?

x At any time during the test was the patient separated from the data receiver?

x Did the patient observe the capsule in their stool confirming body exit?

3. Collect the patient diary.

► Review the diary’s contents to ensure the patient’s notes are legible and comprehensible.

4. Release the patient.

Downloading a Test

1. Turn on the data receiver.

2. Connect the docking station to a source of AC power and to the system
computer’s USB port.

► Check the data receiver’s battery power. If battery power bars are not visible in the lower-

right corner of the data receiver, turn the data receiver off and charge it for 10 minutes before
downloading.

3. Dock the data receiver in the docking station.

4. Launch the MotiliGI software and log in.

x The software detects when the data receiver contains test data. A message asks

whether you want to open the patient’s information.

5. Click Yes. The patient’s file opens. The file name appears in MotiliGI’s title bar.

6. Download the data:

x Select Action > Download Data.

Duration of test

Duration of download (typical)

2 days

<3 minutes

4 days

<5 minutes

x Click the toolbar icon.

The Patient Information screen opens.

Appendix: Electrical Safety

Post Test Notes

7. In the Procedure Notes tab, click in the post-test notes field to enter notes elicited
from the patient which were captured when the patient returned the data receiver.

x See Adding and Creating a Template.

8. Click OK. (If you click Cancel, the data receiver continues to record capsule data
and events.)

The Test Download screen appears.

MotiliGI protects current test data stored on the data receiver until current test data
is completely downloaded.

When the download is complete the MotiliGI software displays the entire test
graph and the Test Summary screen.

9. Turn the data receiver off and place in the docking station to be recharged.

Appendix: Electrical Safety

Confirming Capsule Exit

Caution

Physicians should confirm capsule exit. Monitor patients until capsule passage is confirmed.

1. Use one of these methods:

x Ask the patient whether the capsule was observed in his or her stool.

x Download the test. Analyze the MotiliGI graph for evidence of exit: an abrupt

drop in temperature or loss of signal that coincides with a diary entry for a
bowel movement.

x If you cannot confirm capsule exit cannot using these methods, or suspect a

bowl obstruction, consider an abdominal x-ray and treat consistent with your
management of a foreign object causing obstruction. An abdominal x-ray
determines whether the capsule is retained and its location within the GI tract.

If you suspect a delay in passage and the capsule is in the stomach, consider:

x A pro-motility drug to help empty the capsule from the stomach.

x Endoscopy to retrieve the capsule.

If the capsule is in the colon, consider:

x Laxative therapy to facilitate capsule movement.

x Colonoscopy to retrieve the capsule.

Appendix: Electrical Safety

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The MotiliGI software identifies capsule ingestion, gastric emptying, ICJ, body exit,
and computes GET, SBTT, CTT, SLBTT, WGTT, and motility indices.

You can:

x Match events with patient diary entries.
x Analyze test to mark capsule ingestion, gastric emptying, ICJ and body exit.
x Compare the markers you defined with markers identified by the MotiliGI

software.

Introduction to the Test Analysis Wizard

After downloading a test, a message appears asking if you want to analyze the test.

1. Click Yes. The Test Analysis Wizard appears.

You may close the wizard at any time. If you close the wizard before completing
the analysis:

x The Test Summary screen does not appear.

x The test report will contain the note “Test data not reviewed by physician.”

x The test wizard automatically saves.

To re-open the wizard:

x Click the toolbar icon.

x Select Action > Analyze Test.

The test analysis wizard resumes from your last completed step.

Figure 6 - Test Analysis Wizard

Appendix: Electrical Safety

1

Navigates to any step of the wizard that you have completed

2

Yellow light: You must take action to complete this step.
Green light: You have completed this step.

3

To take an action, click a link.

4

You can enter notes.

Analyzing the Test

Patient Diary Events

Appendix: Electrical Safety

The graph displays each event in succession.

1. Match each journal event with a recorded event, based on time, from the diary.

a. Select an event icon, displayed in this step.

b. (Optional ) Enter a caption and notes.

c. Click Next Event to navigate through all events in the graph.

x To go back to an event click Previous Event.

x If you cannot find a matching event in the diary:

x Select None/No Match from the list.

Appendix: Electrical Safety

Term

Definition

Ingestion

The point where you observe the temperature beginning to rise to body
temperature.

x Hide the event by uncheck the box Show the Event on the Graph.

You can edit this information at any time by using the Point Annotation Viewer or the
Annotation Viewer:

2. Click Next >.

Select Capsule Ingestion

Often, a pH spike to an off-scale value then a decrease to physiologic pH occurs just
before ingestion due to exposure of the capsule to air.

2

1. Click Mark ingestion on the graph

2

Fackler, WK, et. al. Ambulatory gastric pH monitoring: proper probe placement and normal values. Aliment Pharmacol

Ther 2001; 15:1155-1162

Appendix: Electrical Safety

2. Move the cursor over the graph and click on the location where you believe
ingestion occurred.

3. Click Next >.

Gastric Acidity

A stomach baseline pH below 4 indicates normal acidic conditions. Baselines above 4
may indicate ineffective gastric acid production, buffering due to meals, or medications
that suppress gastric acid.

► Click Next >.

Appendix: Electrical Safety

Procedure Deviation ± Additional Meal Before 6 Hours

Snacks or meals may be recorded in the diary. A rise in pH and drop in temperature
may indicate a meal response in the stomach. In figure above there is no evidence of
an additional meal prior to capsule gastric emptying. See the figure below describing an
ingested liquid meal

Caution

Eating anything (except limited quantities of water) before the capsule has emptied the stomach will delay
gastric emptying and invalidate GET results.

► Click Next >.

Food and liquid intake cause a rise in pH which can be mistaken as gastric emptying.

Appendix: Electrical Safety

Figure 7 - Eating a meal

In the figure above, the patient ingested a liquid meal (Ensure) at 6 hours after capsule
ingestion and ate dinner approximately 8 hours after capsule ingestion. The ingestion
of food (Ensure and dinner) caused an abrupt rise in pH (B) and a decrease in
temperature (A).

At approximately 12 hours after capsule ingestion, the pH returned to baseline (below
pH 2) and remained at baseline until the capsule emptied the stomach 18 hours after
ingestion (C).

Select Gastric Emptying

Term

Definition

Gastric emptying

The beginning of the first increase in pH that results in a sustained pH rise.

Sustained pH increase

No transient pH drops occur for greater than 10 minutes.

Appendix: Electrical Safety

Use GET to evaluate the patient’s gastric emptying function. Generally, an abrupt
increase of 3 or more pH units occurs as the capsule exits the stomach and enters the
duodenum.

Caution

Medications, therapies, and diseases may alter gastric or small bowel pH. Alterations in gastric and/or small
bowel pH may mask the physiological pH landmark for gastric emptying time.

1. Click Mark gastric emptying on the graph.

2. Move cursor over to the MotiliGI graph and click on the graph where you believe
gastric emptying occurred.

3. Click Next >.

Magnitude of pH Rise at Emptying

Term

Definition

Duodenal pH baseline

Determined by observing the pH within the first 30 minutes after
gastric emptying.

Sustained pH increase

No transient pH drops occur for greater than 10 minutes.

Appendix: Electrical Safety

► Click Next >.

Gastric Pressure Characteristics

Appendix: Electrical Safety

The relevance of SmartPill pressure patterns in the stomach to pressure patterns
obtained using manometry is unknown.

► Click Next >.

Small Bowel pH profile

1. Determine whether you observe a gradually rising pH profile characteristic of the
small bowel.

Appendix: Electrical Safety

2. Click Next >.

Small Bowel Pressure Characteristics

The clinical significance of SmartPill pressure patterns in the small bowel is unknown.

► Click Next >.

Select Ileo-Cecal Junction

Term

Definition

ICJ

Ileo-Cecal Junction, the start of pH decrease of approximately 0.5–1.0
units.

Appendix: Electrical Safety

The standard small bowel pH profile shows a gradual pH rise usually followed by a
plateau of the pH pattern. Transient pH drops may interrupt this profile but returns to
their previous level within 10 minutes.

The pH drop associated with the capsule passing through the ICJ occurs after the
gradual sustained increase in pH through the small bowel. This drop of approximately

0.5–1.0 pH units usually occurs between 2–6 hours after gastric emptying.

3

Before ICJ, the pH rises smoothly and continuously in comparison to a more erratic
profile after ICJ.

► Click Next >.

3

Zarate N., Scott SM. Accurate localisation of a fall in pH within the ileo-caecal region: validation using a dual

scintigraphic technique. Am J Physiol Gastrointest Liver Physiol 2010; 299 (6): G1276-86.

Colonic Pressure Characteristics

Appendix: Electrical Safety

The relevance of SmartPill pressure patterns in the colon to colonic pressure patterns
obtained using manometry is unknown.

► Click Next >.

Appendix: Electrical Safety

Warning: Data Collected During Capsule Low Voltage

If the MotiliGI software detects a low voltage condition in the capsule, a warning
appears.

Caution

When a low voltage warning is present, body exit confirmation cannot be determined solely by temperature
drop. Low voltage may cause loss of signal before capsule exits the body. Whole gut and small/large bowel
transit times are not definitive without the body exit endpoint. Regional transit times are not valid without
start and endpoints.

1. Read and understand the warning.

2. To acknowledge this warning, check the box I Understand.

3. Click Next >.

Select Body Exit

Term

Definition

Body exit

x The time of the last temperature reading at body temperature, coinciding

with an abrupt loss of capsule data.

x The time of the last abrupt rise in pressure.

Appendix: Electrical Safety

An abrupt loss of signal from the capsule does not reliably indicate body exit. You
must corroborate (to within 30 minutes) body exit with a recorded bowel movement in
the patient diary.

Appendix: Electrical Safety

Figure 8 - Body Exit

The figure above provides an optimal representation of body exit including a bowel
movement event marker on the graph and in the patient diary temperature drop (A), a
decrease in temperature (B) and an abrupt loss of data (C).

Caution

If the diary does not contain a bowel movement entry concomitant with a temperature drop and/or loss of
pressure and pH signal, the patient should be monitored for symptoms of bowel obstruction. If the patient
exhibits symptoms consistent with bowel obstruction, a KUB exam is indicated.

► Click Next >.

Appendix: Electrical Safety

Term

Description

Computed markers

Dashed vertical line on the graph, labeled “computed.”

Your markers

Solid vertical lines.

Equivalent

Your marker and the computed marker are within 5 minutes of each
other, labeled “equivalent.” The computed time is grayed out.

Review Your Physiological Markers with
MotiliGI¶V0DUNHUV

► Click Next >.

MotiliGI-Computed Capsule Ingestion

Appendix: Electrical Safety

MotiliGI determines ingestion by finding the point at which temperature stabilized at
body temperature.

1. Follow the prompts.

2. Click Next >.

Motili GI-Computed Gastric Emptying

Appendix: Electrical Safety

MotiliGI selects gastric emptying by finding the beginning of the abrupt, sustained pH
rise. Medications, therapies, and diseases that alter gastric or small bowel pH may
influence the accuracy of computed gastric emptying.

1. Follow the prompts.

2. Click Next >.

Appendix: Electrical Safety

Absence of Gastric Emptying

If you did not identify gastric emptying, the wizard reminds you of the omission and
asks you to select gastric emptying.

x To review the MotiliGI computed gastric emptying, click <Back.

Caution

If gastric emptying is not observed, body exit should be confirmed by analysis of data. If body exit cannot be
confirmed, the patient should be monitored for symptoms of bowel obstruction. If the patient exhibits
symptoms consistent with bowel obstruction, a KUB exam is indicated to determine capsule exit or retention.

1. Follow the prompts and select Yes or No.

2. Click Next >.

Gastric Emptying Statistics

Appendix: Electrical Safety

This step allows you to enter observations about the gastric emptying statistics.

► Click Next >.

Gastric Emptying Time Evaluation

Term

Definition

Premature gastric emptying

Within 30 minutes of ingestion.

Normal gastric emptying

After 2 hours but before 4 hours of ingestion.

Delayed gastric emptying

After 4 hours of ingestion.

Appendix: Electrical Safety

Use GET to evaluate the patient’s gastric emptying function.

► Click Next >.

MotiliGI-Computed ICJ

Appendix: Electrical Safety

MotiliGI selects ICJ by looking for the first and largest pH drop between 30 minutes
and 6 hours after gastric emptying.

1. Follow the prompts.

2. Click Next >.

Small Bowel Transit Time Evaluation

Appendix: Electrical Safety

The clinical significance of SmartPill’s transit time in the small bowel is unknown.

► Click Next >.

MotiliGI-Computed Body Exit

Appendix: Electrical Safety

MotiliGI selects body exit based on temperature and pressure. An abrupt loss of signal
from the capsule does not reliably indicate body exit. You must corroborate (to within
30 minutes) body exit with a recorded bowel movement in the patient diary.

Caution

If the diary does not contain a bowel movement entry concomitant with a temperature drop and/or loss of
pressure\pH signal, the patient should be monitored for symptoms of bowel obstruction. If the patient
exhibits symptoms consistent with bowel obstruction, a KUB exam is indicated.

1. Follow the prompts.

2. Click Next >.

Absence of Body Exit

If you did not identify body exit, this step appears.

Appendix: Electrical Safety

x To review the computed body exit, click <Back.

Caution

If the diary does not contain a bowel movement entry concomitant with a temperature drop and/or loss of
pressure and pH signal, the patient should be monitored for symptoms of bowel obstruction. If the patient
exhibits symptoms consistent with bowel obstruction, a KUB exam is indicated.

Caution

If MotiliGI displays a low voltage indication on the graph, the validity of data collected during the low voltage
state cannot be determined, including any temperature drops that mimic body exit.

1. Select Yes or No.

2. Click Next >.

Colonic Transit Time Evaluation

Appendix: Electrical Safety

MotiliGI uses your interpretation of ICJ (colonic entry) and body exit events to
compute the CTT.

► Click Next >.

Test Analysis Review

The analysis is complete.

Appendix: Electrical Safety

► Click Finish.

Reading Test Summary Reports

When the test analysis wizard is complete, a summary report of results and descriptive
data appears.

These reports summarize test data, statistics, and observations, and help evaluate
delayed gastric emptying, constipation and gastrointestinal motility.

You can display the test summary reports any time:

x Click the toolbar icon.
x Select View > Test Summary.

Appendix: Electrical Safety

Action

Tools to use

For more information

Edit ingestion time, gastric emptying
time a

Graph marker tools

Chapter 8: MotiliGI Features
Edit or enter motility statistics

Statistics Mode tools

Chapter 8: MotiliGI Features

Transit Data Tab

This tab lets you compare your transit time data to the computed data.

x If one or more endpoint markers are not defined, n/a (not applicable) appears for

the transit time value.

x Combined small and large bowel transit time (SLBTT) can be used as a surrogate

measure for CTT when CTT cannot be determined.

You can edit the data at any time, and the corresponding reports update accordingly:

nd body exit time

Appendix: Electrical Safety

Descriptive Data Tab

This tab summarizes calculated pressure and pH data points. The clinical significance
of these pressure and pH descriptive statistics is unknown.

Appendix: Electrical Safety

Goal Action

Create a template

Enter a title in the Template field and a description in the text
field below it. Click Save Template.

Delete a template

Select the title in the Template list. Click Delete Template.

Add the description to the patient’s record
Select the template title. Click .

Remove the description from the patient’s
record

Select the description in the Patient record box. Click Remove
Entry.

Print a description in the final report

Select checkboxes in the Patient record box.

Interpretations Tab

This tab displays notes made during analysis and provides a text section for capturing
post-test observations, conclusions and recommendations. The information entered in
this tab becomes part of the patient’s record.

Alternatively, you can enter interpretations through the Interpretations tab of the
Patient Information screen. Interpretations can be entered before or after the test is
downloaded.

Click to use preconfigured templates to describe test interpretations.

Appendix: Electrical Safety

Properties Tab

This tab displays information about the equipment used for the test.

Examples of Physiological Markers

Ingestion

The ingestion landmark starts the test and is the beginning of GET. MotiliGI
determines the ingestion landmark by finding the point just before temperature
stabilizes to body temperature, as illustrated below. The pH also starts to become
more acidic.

Figure 9 - Ingestion

B

A

Appendix: Electrical Safety

Gastric Emptying

Gastric emptying marks the end of GET and the start of SBTT as shown below.

Figure 10 - Gastric Emptying

MotiliGI looks for an abrupt increase of 3 or more pH unit as the capsule exits the
stomach and enters the duodenum.

Appendix: Electrical Safety

E

B

A

ICJ

D

C

Factors that may influence gastric emptying include:

x Medications, therapies, and diseases that alter gastric or small bowel pH.

ICJ

ICJ is usually found between 2 to 6 hours after gastric emptying, as seen below. ICJ
marks the transition of the capsule from the small bowel into the colon. ICJ marks the
end of SBTT and the start of CTT.

How to find ICJ:

1. Locate gastric emptying

2. Look for a steady rise in pH followed by a plateau.

3. Look for a 1 to 2 unit pH drop between 2 to 6 hours after gastric emptying

x A high amplitude spike in pressure is often seen near ICJ

x After ICJ an erratic pH profile in the colon is characteristic

Figure 11 - ICJ

Body Exit Time

Body exit marks the end of the test as shown below. Body exit marks the exit of the
capsule from the body and the end of WGTT and CTT.

Appendix: Electrical Safety

Figure 12 - Body Exit

Appendix: Electrical Safety

Back to Previous View

Forward to Next View

New – Start a new test

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MotiliGI User Interface

The MotiliGI user interface consists of main dropdown menus, toolbar, graph area,
control panels, time slider control and status bar.

Figure 13 - MotiliGI User Interface

Titlebar

Labeled A on Figure 13.

The titlebar displays the filename constructed from the Patient ID and the time and
date of the beginning of the test, for example Patient ID #207516, 9:29:44 AM, 28
March, 2007.

Main Menus

Labeled B on Figure 13.

Toolbar Icons

Labeled C on Figure 13.

Appendix: Electrical Safety

Open – Open a test. You can choose to open by patient name or filename.

Live Monitoring

Download Data

Analyze Test
Print

Print Preview

Generate Report

Test Summary

Patient Info

Annotation Viewer

Display Ingestion
Display Stomach

Display Gastric Emptying

Display Small/Large Bowel

Display Body Exit
Display Entire Test

Show/Hide Pressure

Show/Hide pH

Show/Hide Temperature

Zoom In

Zoom Out

Show/Hide Annotations
Annotations

Statistics

Set Ingestion Marker

Appendix: Electrical Safety

Set Gastric Emptying Marker

Set ICJ Marker

Set Body Exit Marker

Graph Area

Labeled D on Figure 13.

The graph area presents plots of pressure, pH, and temperature data captured
throughout the test, and point and range annotations.

The left Y-axis is the pressure scale, the right Y-axes are pH and temperature scales,
and the X-axis is the elapsed time of the test.

Data Panels

Labeled E on Figure 13.

MotiliGI’s two data panels, positioned to the right of the graph area, provide
information and controls related to test “Statistics” and graph “Location.”

To show or hide the data panel:

► Double-clicking the bar between the graph and the data panels.

Time Slider Control

Labeled F on Figure 13.

The time slider control shows what appears in the main graph in relation to the entire
test.

Display Tabs

Labeled G on Figure 13.

Navigate between the Graph (statistics panel), Help (user manual) and Analysis Wizard
(not pictured).

To show or hide the data panel:

► Double-clicking the bar between the graph and the data panels.

Status Bar

Labeled H on Figure 13.

The status bar displays the username, and data receiver and test status icons. MotiliGI
uses 7 icons to indicate the status of the data receiver and test.

Data Receiver Status Icons

Icon Description

Disconnected – No USB connection exists between MotiliGI and the data receiver.

Connected – MotiliGI is communicating with the data receiver.

Icon Descriptio

n

Capsule Not Found – MotiliGI is not receiving data from a capsule and indicates a capsule has

not been activated or the capsule is out of range of the data receiver.

Test Status Unknown – MotiliGI cannot determine the status of the test.

Test Ready to Begin – MotiliGI is properly communicating with the data receiver and the

capsule. This icon appears during capsule calibration.

Test in Progress – The test has begun. The data receiver is recording data from the capsule.

Test Ended – Data collection has stopped. This icon appears during data download.

Keyboard Shortcut

Effect

Control X

Cut text from any form field, copied to the clipboard

Control C

Copy text from any form field to the clipboard

Control V

Paste text from the clipboard to any form field

Tab

Move from one text field to the next

Enter

Press the default button for the current form, panel, or dialog box

Test Status Icons

Appendix: Electrical Safety

MotiliGI Keyboard Shortcuts

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1. Open a test:

x Click on the toolbar.

x Click File > Open

2. Select By Patient Name. The Find Patient window appears.

Appendix: Electrical Safety

x To show all tests in the Results box, click Show All Tests.

x To reduce the size of the list, enter all or part of the patient’s name or patient ID.

You can also enter a test date or range of dates in the “Find by test date” box.

3. Click Search. MotiliGI displays matching tests in the Results box.

4. Click a row to select the patient’s test.

5. Click Open.

Opening a Test by the File Name

1. Open a test:

x Click on the toolbar.

x Click File > Open

2. Select By Filename. The Open File screen appears.

3. Browse to the test file:

x Windows XP: C:\Documents and Settings\All Users\Application

Data\SmartPill\Tests

x Windows 7: C:\ Program Data\SmartPill\Tests

4. Click Open.

Closing a Test

► Select File > Close.

MotiliGI saves changes to the test when you close.

Appendix: Electrical Safety

Exiting MotiliGI

MotiliGI saves changes to the test when you exit. To exit MotiliGI, either:

x Select File > Exit

x Close using the in the upper right hand corner.

Caution

Do not close MotiliGI while operating the Test Initiation Wizard because data can be lost. Complete or abort
the Wizard first.

Caution

Do not close MotiliGI while downloading a test because data can be lost. Allow the test to fully download.

Setting General User Preferences

Each user can have saved preferences for the General, Graph and File tabs. Report
preferences apply to all users.

To customize the look and feel of the user interface:

► Select Tools > Options.

General Tab

You can select preferences for the User Interface:

x The number of tests appearing in the File > Recent Tests menu.

Appendix: Electrical Safety

x The number of physician’s names appearing in the Ordering and Primary Care

Physician drop down lists on the General tab of the Enter Patient Information
screen.

x The display language. Changes will take effect when you restart MotiliGI.

x The unit of measure, English or metric.

You can select preferences for the view displayed when MotiliGI opens a test:

x Ingestion and the number of hours displayed after ingestion

x Stomach

x Gastric emptying and the number of hours displayed before and after gastric

emptying

x Small/large bowel

x Body exit and the number of hours displayed before body exit

x Entire test

Graph Tab

You can select preferences for the Plot Area Properties for Time, Pressure, pH and
Temperature:

x Color, line style, and point style of data plot

Appendix: Electrical Safety

x Show or hide the plot

x The ranges, tick values and colors of the X and Y axes

You can select preferences for Visibility:

x Show or hide gridlines, annotations, and missing data packets

You can select preferences for Color Scheme:

x The color of gridlines, annotations, title text, and background color

Report Tab

You can select an option for printing reports. MotiliGI lets you print reports on your
own letterhead stationery or create a custom letterhead.

You can select report options. You can choose to include the following in the report:

x Letterhead and paper size

x Administrative information including test statistics, study comments, and screen

prints of the Test Summary screens.

x The patient’s information.

x The Annotation information including statistics and notes.

x The plots to be graphed: pressure, pH, temperature and annotations.

x The graph views of the test.

Creating Report Letterhead

1. Select Tools > Options > Report Tab.

2. Choose paper size.

3. Click Create Letterhead.

x The Letterhead Creator appears:

Appendix: Electrical Safety

Add text to the letterhead

1. Click New Text Box. A text box appears in the new letterhead.

2. Type the desired text.

3. Click and drag the text box to move to a location in the Letterhead Canvas.

x You can modify the font, resize the text box or delete the text box.

a. Right-click in the text box.

b. Choose desired option.

c. To resize the text box drag your mouse to the desired size and click to apply.

d. Click OK.

4. Click Save.

Add an image to the letterhead

1. Click New Image Box. An image box appears in the new letterhead.

2. Right-click in the image box to select an image.

3. Click Browse for Image... An Open Image screen appears.

4. Find and select a bitmap, JPEG or GIF file.

5. Click OK.

x You can modify the image appearance, resize or delete the image box.

► Right-click in the image box. Choose desired option.

x To resize the image box drag your mouse to the desired size and click to

apply.

6. Click Save.

Files Tab

Appendix: Electrical Safety

You can select the target folder to save files to.

x Click Browse to find target folder.

x Type in the folder location.

Setting Preferences Back to Default

► Click Restore Defaults to return all tabs and settings to default states. Your language preference

remains the same.

Editing Patient Information

Edit patient information any time after the start of the test. Patient information is
initially entered in the test initiation wizard. You can edit information on all tabs
within the patient information screen.

If you edit the patient ID, MotiliGI updates the electronic test filename, log filename
and the folder containing the files with the new patient ID number and it will ask you
to confirm. If you previously generated a report (WordPad document), your report
filename and patient ID number will not be updated. You will need to generate a new
report.

1. To access the patient information either:

x Click on the toolbar

x Click View > Patient Info.

Appendix: Electrical Safety

2. Edit the patient’s information.

3. Click OK.

Changing the Graph Display

Selecting Data Plots

MotiliGI gives you 3 methods to select the data (pressure, pH and temperature)
displayed on the graph:

Method 1 ± Context Menu

x Right-click on the graph and select a data plot. A checkmark indicates the

plot appears on the graph.

Method 2 ± Toolbar Icons

Show/Hide Pressure

Show/Hide pH

Show/Hide Temperature

► Click on a “Show/Hide” data plot icon.

Appendix: Electrical Safety

Method 3 ± Main Menu

► Click View > Plots. Select a data plot icon to toggle the plot.

Changing the Test View

x To undo any view operation, click the toolbar icon.

x To redo a view operation, click the toolbar icon.

MotiliGI prefers the physician-determined marker rather than the computed marker to
define the regions.

MotiliGI gives you several methods to select a test view.

Method 1 ± Context Menu

► Right-click on the graph and select a desired view.

Method 2 ± Main Menu

► Click Go and choose a desired view.

Method 3 ± Toolbar Icons

► Click on a display icon

Display Ingestion – Test data around the ingestion marker.
Display Stomach – Test data between the ingestion marker and the gastric emptying marker.

Display Gastric Emptying – Test data around the gastric emptying marker

Display Small/Large Bowel – Test data from the gastric emptying marker to the body exit

marker.

Display Body Exit – Test data around the body exit marker.

Display Entire Test – Test data from the ingestion marker to the body exit marker.

Method 4 ± Time Slider Control

Appendix: Electrical Safety

The portion of the test shown in the graph area is highlighted in white.

To move the slider:

1. Place your cursor on the slider. The cursor changes to a finger.

2. Click and drag the cursor to the left or right.

3. Release the cursor. The main graph updates.

x You can also move the slider with the scroll wheel on the mouse.

To zoom with the slider:

1. Place your cursor over the border of the highlighted area. The cursor changes to a
double arrowhead.

2. Click and drag the border to the left or right.

3. Release the cursor. The main graph updates.

Method 5 ± Zoom Controls

To zoom in:

1. From the toolbar, select . The cursor changes to a magnifying glass icon.

2. Select an area to view by:

x Clicking on a graph location (This method only zooms in on the X axis)

Appendix: Electrical Safety

x Clicking and dragging your mouse to select a graph region (This method zooms

in on both the X and Y axis)

3. Click to exit the zoom in mode. The cursor returns to normal.

x To return to your last view use the icon.

To zoom out:

1. From the toolbar, select . The cursor changes to a magnifying glass icon.

2. Select an area to view by clicking on a graph location.

3. Click to exit zoom out mode. The cursor returns to normal.

Method 6 ± Using the Data Panel: Location

1. Define a window of time by selecting Start and End Times or Time In Center

2. Enter the time you wish to display.

3. Click Set Graph.

Changing Axis Scales

Y Axes

To change the scale of the pressure, pH or temperature axis:

1. Double-click on the desired axis.

2. Enter the new axis scale minimum and maximum values.

3. Click OK.

To restore the scale to the saved user preferences:

1. Double-click on the desired axis.

2. Click Restore Axis Defaults or Restore Defaults for All Axes.

Appendix: Electrical Safety

3. Click OK.

X Axis

To change the time format between calendar date/time and elapsed time either:

x Double-click on the time axis to toggle between elapsed time or real date/time.

x Go to Tools > Options >Graph > Time Axis

Analyzing Data

Showing and Hiding Annotations

Annotations include patient diary events, range annotations, and point annotations.
Annotations are visible by default.

x To toggle the visibility of all graph annotations, click on the toolbar.

Editing Patient Diary Events

To view and edit patient diary events

1. Open the Annotation Viewer:

x Click on the toolbar.

x Select View > Annotation Viewer.

The Annotation Viewer screen appears.

2. Click the event you wish to edit. The event details appear in the annotation
properties box.

3. Select an icon from the Journal Event drop-down list. The Update button appears.

Appendix: Electrical Safety

x (Optional) You can enter text in the Caption box and in the Notes box.

Caption text shows on the graph, while Notes text shows in the Annotation
Viewer and in the printed report.

x You can click the checkboxes to show or hide the annotation and the caption.

4. Click Update to save changes.

Disregard diary entries and events that do not have a reasonable time correlation.

Creating New Event Annotations

To enter an event that does not appear on the graph:

1. Click on the toolbar. The cursor changes to a similar icon.

2. Click on the graph at the appropriate time to create the annotation. The Point
Annotation Editor appears.

3. Select an icon from the Icon dropdown box.

► (Optional) You can enter text in the Caption box and the Notes box. Caption text shows on

the graph. Notes only show in the Annotation Viewer, Point Annotation Editor and in the
printed report.

x You can view the time, pH and pressure values at the selected graph point.

x You can click the checkboxes to show or hide the annotation and the caption.

4. Click OK.

► To exit the Annotation mode, click on the toolbar. The cursor returns to normal.

Editing Event Annotations

Event icons cannot be moved, only deleted or hidden. An event created by the patient
pushing the event button on the data receiver cannot be deleted; it can only be hidden.
Physician-created annotations can be deleted.

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Double-click the event icon. The Point Annotation Editor appears.

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Physiological Markers

Marker
Color

Toolbar
Icon

Ingestion - Time the capsule was ingested

Blue

Gastric emptying - Time the capsule left the stomach

Silver

Ileo-cecal junction - Time the capsule entered the colon

Green

Body exit - Time the capsule left the body

Magenta

Appendix: Electrical Safety

1. Click on the toolbar.

2. Move cursor over the caption text. The cursor changes to a crosshair.

3. Click and drag the caption text to a new location.

To delete an annotation:

1. Double-click the event icon. The Point Annotation Editor appears.

2. Click Delete.

Adding or Changing the Location of Physiological Markers

Physiological markers are used to compute transit times. MotiliGI-computed markers
appear on the graph as dotted vertical lines. Physician-defined markers appear on the
graph as solid vertical lines.

To add or change the location of a marker:

1. Click the appropriate toolbar icon. The cursor changes to a crosshair.

2. Click the graph to set the marker at a location. The cursor returns to normal.

To clear (delete) a physician-defined marker:

► Select Markers > Clear Defined Markers…

You can choose to clear one or all physician-defined markers.

To hide a marker:

► Select Markers > Show/Hide Markers

You can choose to show/hide one or all physician-defined and MotiliGI-computed
markers.

Appendix: Electrical Safety

Viewing Transit Times

x Click on the toolbar.

x Select View > Test Summary

The Test Summary screen appears. Transit times computed using the physician­defined markers appear on the left and MotiliGI-computed markers appear on the
right.

Calculating Statistics

To enter the Statistics mode:

1. Click on the toolbar. The cursor changes to .

2. Click and drag to select any area of the graph.

A yellow box appears around the selected area and creates a range. The Statistics
panel displays pressure, pH and temperature statistics for the range.

To save the range as an annotation on the graph:

1. On the statistics panel, click Save Annotation. The Range Annotation Editor
screen appears.