SmartPill GI Monitoring System User Manual v3.0 March 2013

Appendix: Electrical Safety

Copyrights

Text, graphics, logos and images in this manual are the property of Given Imaging and protected by United States and international copyright laws. This Manual may not be transferred or reproduced in any form without the written permission of Given Imaging. Copyright © 2006-2012 Given Imaging. All Rights Reserved. Trademarks

MotiliGI® and The Measure of GI Health® are registered trademarks, and SmartPill™ and the SmartPill logo are trademarks of Given Imaging. Such marks are protected by United States common law, federal and/or international trademark laws and may not be used in violation of Given Imaging’s rights. Patents

Certain uses and features of the products referenced herein are protected by one or more United States and international patents or have pending patent applications. Limited Warranties

The SmartPill GI Monitoring System Given Imaging warrants the system* for a period of one (1) year from date of purchase, and that the components of the system* have been designed, manufactured, packaged and tested and, if properly used, are free from any defect of workmanship or materials that would materially and adversely affect their intended use. If any component of the system* fails during the period of this Limited Warranty for reasons covered by this Limited Warranty, Given Imaging, at its option, shall replace the specific failed component. This Limited Warranty does not cover failure occurring in connection with or arising out of uses not intended by Given Imaging, misuse, neglect, alteration, repair, improper installation or improper testing. Without limiting the generality of the foregoing statement, this Limited Warranty shall be invalidated if any repairs, services or modifications are made to any of the components by any person not explicitly authorized by Given Imaging. Given Imaging is not liable or otherwise responsible for any loss, damage, or expense arising, directly or indirectly, from the use of the system* or SmartPill capsule. Without limiting the generality of the foregoing statement, customers are liable for all matters beyond Given Imaging’s control such as handling, storage, cleaning, misuse, treatment and diagnosis.

Appendix: Electrical Safety This Limited Warranty is in lieu of and excludes all other warranties, whether expressed or implied, including without limitation warranties of merchantability or fitness. Extended Warranty Options are available. * Only the data receiver, docking station and activation fixture of the SmartPill GI Monitoring System are covered by this Limited Warranty: The SmartPill Capsule Given Imaging warrants each Capsule is free from defects in workmanship and materials until the Capsule’s labeled expiration date. If Given Imaging verifies capsule failure during the warranty period for reasons covered by the Limited Warranty, Given Imaging shall replace the failed capsule. Additional Limitations The Limited Warranty does not cover software or damages due to misuse, neglect, alteration, repair, improper installation, set-up, calibration or improper testing. Given Imaging is not liable for any incidental or consequential loss, damage, or expense arising, directly or indirectly, from the use of the system or capsule. Customers are liable for all matters beyond Given Imaging’s control such as handling, storage, cleaning, misuse, treatment, and diagnosis. This warranty is in lieu of and excludes all other warranties whether expressed or implied warranties of merchantability or fitness. The System Computer The system computer is covered under the manufacturer’s warranty. Rx Only

Given Imaging 3950 Shackleford Road, Suite 500 Duluth GA 30096 USA [email protected] Given Imaging GmbH Borsteler Chaussee 47 D-22453 Hamburg, Germany [email protected]

This device complies with Part 15 of the FCC. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation.

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

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

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

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

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

Appendix: Electrical Safety

,QWURGXFWLRQDQG&RPSRQHQWV

Using this Manual Complete user training and read this manual before running the SmartPill System. This manual contains important safety information and contraindications. This manual makes use of 2 special notations: Warning and Caution, the meanings of which are: Warning

Potentially hazardous situations which could result in serious adverse reactions (death or serious injury) or serious safety hazards to users and patients. All warnings are boxed. Caution

Potentially hazardous situations which could result in minor or moderate injury or damage to the equipment or other property.

Appendix: Electrical Safety

System Components SmartPill Capsule Pack Each capsule pack contains a single-use capsule, calibration buffer, instructions for use and a patient diary. The capsule measures pressure, pH, and temperature to determine transit times of the stomach, small bowel, and colon. Transit times derived by capsule motility procedures provide alternatives to other tests such as gastric emptying scintigraphy, whole gut scintigraphy, and radio-opaque markers. Caution

Do not use a SmartPill capsule if it has been dropped as this may affect function.

Capsule Operational Specifications Attribute

Specification

Pressure Accuracy

0-99 mmHg ± 5 mmHg 100-350 mmHg ± 10% of applied pressure 0-350 mmHg ± 0.5 pH units 1–9 pH units ± 1°C (between 20 – 42ºC) 434.2 MHz (radiating between 426 – 445 MHz) Capsule and Data Receiver, >5 days 4.5 grams 26 x 13mm

Pressure Range pH Accuracy pH Range Temperature Accuracy Transmission Frequency Battery Life Weight Size

SmartBar The SmartBar is a standardized meal that is ingested immediately before capsule ingestion. To accurately measure gastric emptying patients must consume a standard meal immediately before ingesting the capsule.

Appendix: Electrical Safety Data Receiver The data receiver records biomedical data sent by the capsule. It is worn by the patient on a belt clip or a lanyard (around the neck). The data receiver features an Event button that when pushed places a marker in the electronic data. A patient diary for recording the time and reason for the event button use is stored on the backside of the receiver. The data receiver weighs approximately 225g (0.5 lb). Caution

Use only the SmartPill Docking Station (REF 50100400) to charge and download data from the receiver.

Figure 1 Feature

Description

A - Data Display

See Data Receiver Display Modes, Page 19 for more details.

B – Backlight Control The backlight button turns on a light, enabling the display to be read in low light Button conditions. The backlight button is also used to turn the data receiver off. The backlight button and event 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 event button inserts a marker in the test data record.

D – Belt Clip and Lanyard

The data receiver is equipped with a belt clip and supplied with a lanyard. The patient has the choice of clipping the data receiver on a waist belt or wearing the data receiver suspended from a lanyard.

E – Patient Diary

The patient diary is to be used by the patient to record events, activities and symptoms listed in the patient instruction sheet, and the date and time the events occurred. The entries in the patient diary should correspond to the event button markers inserted into the test data record when the event button is pressed.

Appendix: Electrical Safety Docking Station The docking station establishes electronic communication between the data receiver and the system computer for data download and serves as a charging stand for the data receiver. The docking station weighs approximately 200 grams (0.45 lbs). Caution

Use only the Power Supply (REF 30100900) supplied with the SmartPill Docking Station.

Figure 2

Feature

Description

A – LED Light

Indicates the state of data receiver. See table below.

B – DC Power Connector

Provides a connection point for the power supply.

C – USB Connector

Provides a connection point for the USB cable, connecting the docking station to the system computer.

Appendix: Electrical Safety LED Color

State

Action Recommended

Red Yellow

Charging A charging circuit fault has occurred

Green Off

Fully charged

Continue charging until the LED turns green. Undock and then re-dock the data receiver in the docking station. If the yellow light persists contact technical support. The data receiver is ready for use.

x

x

Connect the docking station to a source of AC power.

x

Undock and then re-dock the data receiver in the docking station. Contact technical support for assistance.

x x

Docking station is not connected to an AC power source Receiver is not fully connected to the docking station Docking station or data receiver are in thermal shutdown

x

Activation Fixture

The activation fixture turns the capsule on and off using strong magnets that interact with the capsule’s internal power switch. Warning

Individuals with pacemakers should not come within one (1) foot of the SmartPill activation fixture. The fixture contains strong magnets that could interfere with pacemaker operation. Warning

Do not store the SmartPill Activation Fixture in the same room with or a room adjacent to MRI equipment. The fixture contains strong magnets and could become a dangerous projectile. Caution

Keep the SmartPill Activation Fixture more than two (2) feet from magnetic media and computer monitors. Caution

Do not store unused capsules within one (1) foot of the SmartPill Activation Fixture. Stray magnetic fields from the activation fixture may activate the capsule.

System Computer and MotiliGI Software MotiliGI software comes installed on the system computer. MotiliGI receives and processes downloaded data from the data receiver, stores test data, provides data analysis tools, and graphically displays test results. MotiliGI features algorithms that calculate GET, SBTT, CTT, WGTT, and motility indices of the antrum and

Appendix: Electrical Safety duodenum. An optical mouse is supplied with the system computer. An electronic copy of this user manual is included in the software. Caution

Use MotiliGI only on the system computer supplied with the SmartPill GI Monitoring System. Installing and operating MotiliGI on another computer is not recommended or supported by SmartPill Corporation. Caution

Do not use the vertical pipe (|) character in text fields or the software will remove it.

Minimum System Computer Requirements Manufacturer Operating System

Hard Drive Communication Port Peripherals Processor Memory Display

Other

Dell (preferred), IBM, HP, Toshiba 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 System does not work with 64-bit operating systems 100 megabytes of available space for the MotiliGI application and 10 gigabytes of available space for test files (recommended) 1 open USB port CD/RW Drive; printer is optional Pentium IV 1 Gigahertz (GHz) or higher 1 gigabyte (GB) of RAM or 1280 x 800 resolution widescreen aspect ratio (recommended) 96 dpi 32-bit color Microsoft .NET Framework 1.1 SP 1 Adobe Acrobat 7.0.8 or later

Accessories Your starter kit includes the acceosories below: Accessory

Description

Starter Kit Backpack

A protective backpack that holds the system components. Attach to the back of the data receiver. Complete the user training and read this manual before running the SmartPill System. The user manual contains important safety information. Connects the docking station to the system computer. Powers the docking station Instruction sheets to send home with the patient Modifies the power supply.

Belt Clips and Lanyards User Manual

USB Cable Power Cord Patient Instruction Sheets Power Adaptor (non US systems)

Appendix: Electrical Safety Warning

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

Appendix: Electrical Safety

8VHDQG&DUHRIWKH6VWHP Acronyms, Use, and Symbols Acronyms GET

Gastric emptying time

SBTT

Small bowel transit time

CTT

Colonic transit time

SLBTT

Combined small and large bowel transit time

WGTT

Whole gut transit time

Intended Use/Indications for Use The SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal (GI) tract transit times are used for evaluating motility disorders. The system measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices. Suspected disease or condition to evaluate

Indicated

Use

Gastroparesis

GET

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

Chronic constipation

CTT

Aids in differentiating slow and normal transit constipation.

SLBTT

A surrogate measure of colonic transit in patients with chronic constipation when CTT alone cannot be determined.

Measurement

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 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 System Computer

110/220 VAC, 50–60 Hz

May require the use of a power plug adapter

Docking Station

110/220 VAC, 50–60 Hz

May require the use of a power plug adapter

Capsule

3.1 VDC self-contained batteries

none

Data Receiver

8.4 VDC, self-contained,

none

Appendix: Electrical Safety rechargeable batteries Recycling and Disposal Instructions 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 Caution, consult accompanying documents Consult directions for use US FCC compliance Prescription use only Recycle. Dispose of properly Single use only. Do not reuse Part or catalog number Manufacturer Date of manufacture Use by YYYY-MM Lot number Minimum and maximum storage temperature Caution: Strong magnet Warning: Keep away from pacemakers

Appendix: Electrical Safety Type BF equipment

BF

CE marking and notified body number

0123

Authorized representative Sufficient for one test IP57

Ingress protection rating Serial number Fragile Keep dry

Data Receiver Display Messages Looking for capsule-appears during test initiation before the receiver receives the first data packet from the capsule. Locked onto capsule-appears after the data receiver receives first data packet from the capsule. Test in progress-appears when a test is in progress and the data receiver is turned off and back on. Data to download-appears when the data receiver stops collecting data and has data to be downloaded.

Time

Pressure

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

pH

Signal Strength

Indicates the data receiver is writing data from the capsule. Indicates the event button is pushed. The capsule’s data was received. / [X] indicates the data was not received.

Appendix: Electrical Safety The receiver’s battery life. 1 bar = 1 day of battery life. 3 bars = 3+ days.

Risks and Safety Warning

This device does not differentiate between slow motility and functional outlet obstruction.

Non-Passage Risks associated with capsule ingestion and transit are minimal. The primary hazard is capsule retention. Retention incidence, as determined by a review of published studies of capsule endoscopy in adults, is estimated as 0.75% in patients without known stenosis and 21% in patients with known stenosis. Stenosis and strictures can be complications in inflammatory bowel disease. If you suspect a delay in passage and the Capsule is located in the stomach, a 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)

Number of Events Reported

59

Number not related to the device

33

Number probably not related to the device

17

Number possibly related to the device

5

Number definitely related to the device

4

Reported Adverse Events in Clinical Practice

In clinical practice since 2007, the company identified 25 events whose circumstances suggested a potentially reportable event to regulatory authorities. After investigation and follow up, seven of these events were deemed reportable including three instances of esophageal retention, one gastric retention and three small bowel retentions. Surgery was required for resolution in one instance of capsule small bowel retention that led to identification of a stricture. A bowel prep resolved the second instance of small bowel retention, and the third resolved with fluids and bed rest. Capsule retention in the stomach was resolved endoscopically. Two of the retentions in the esophagus were resolved endoscopically and in the third instance the patient vomited and then performed a self-applied Heimlick maneuver to expel the capsule. There