Appendix: Electrical Safety SmartPill® GI Monitoring System User Manual MotiliGI® v3.
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.
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.
Appendix: Electrical Safety Table of Contents ............................................................................................................................................. 1 Introduction and Components ............................................................................................... 9 Using this Manual ................................................................................................................. 9 System Components ............................................
Appendix: Electrical Safety Setting up the Computer ................................................................................................ 23 Preparing for a Test ............................................................................................................... 25 Before the Test Day ........................................................................................................... 25 Charging the Data Receiver ..................................................................
Appendix: Electrical Safety Gastric Acidity .................................................................................................................52 Procedure Deviation – Additional Meal Before 6 Hours ..........................................53 Select Gastric Emptying .................................................................................................55 Magnitude of pH Rise at Emptying ..............................................................................
Appendix: Electrical Safety MotiliGI Features................................................................................................................... 83 MotiliGI User Interface ..................................................................................................... 83 Titlebar ............................................................................................................................. 83 Main Menus ......................................................................
Appendix: Electrical Safety Viewing Transit Times..................................................................................................100 Calculating Statistics ......................................................................................................100 Creating Output ................................................................................................................101 Generating a Report.................................................................................
Appendix: Electrical Safety ,QWURGXFWLRQ DQG &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.
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.
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).
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.
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.
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.
Appendix: Electrical Safety Warning Do not connect items to the SmartPill GI Monitoring System that are not part of the system.
Appendix: Electrical Safety 8VH DQG &DUH RI WKH 6\VWHP 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.
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.
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.
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.
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.
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.
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.
Appendix: Electrical Safety 6HWWLQJ-8S WKH 6\VWHP 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. User Name Password sgims1 12345 2.
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.
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.
Appendix: Electrical Safety Preparing the Patient Before the Office Visit 1. Review these requirements and restrictions with the patient. The test requires fasting for accurate results. 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. 2. Review the use of medications with the patient.
Appendix: Electrical Safety Rolaids 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.
Appendix: Electrical Safety During the entire test x Do not use tobacco. x x Do not consume alcohol. If you are diabetic, monitor glucose levels and follow your personal treatment plan. If you are unsure, contact the doctor who manages your diabetes. Avoid vigorous exercise such as sit-ups, abdominal crunches, and prolonged aerobic activity (greater than 15 minutes). Do not wear the data receiver while bathing or showering.
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.
Appendix: Electrical Safety 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.
Appendix: Electrical Safety x x x Replace the data receiver with a fully charged receiver. Allow additional charging time for the current receiver. 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.
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.
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 >.
Appendix: Electrical Safety Step 4: Activate Capsule 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.
Appendix: Electrical Safety x The data receiver’s display then indicates the capsule’s data: Capsule Serial number P = pressure x The ► SS = signal strength The capsule’s data was received. / [X] = The data was not received. 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.
Appendix: Electrical Safety 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.
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.
Appendix: Electrical Safety 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. C A B Figure 5 - Capsule Orientation A – Capsule pH sensor B – Buffer filling channel C – Diamond shaped window Do not discard the capsule container’s cover.
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.
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 >.
Appendix: Electrical Safety Step 10: Complete Discharge Checklist 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.
Appendix: Electrical Safety Guidelines: Indication for Use Return Data Receiver After Measuring GET Measuring WGTT 24-48 hours 2–5 days 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.
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.
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.
Appendix: Electrical Safety x Select Action > Download Data. x Click the toolbar icon. The Patient Information screen opens. 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.
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.
Appendix: Electrical Safety $QDO\]LQJ WKH 7HVW 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.
Appendix: Electrical Safety 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 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.
Appendix: Electrical Safety 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 Term Definition Ingestion The point where you observe the temperature beginning to rise to body temperature. 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.
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.
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).
Appendix: Electrical Safety Select Gastric Emptying 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. 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. Caution Medications, therapies, and diseases may alter gastric or small bowel pH.
Appendix: Electrical Safety 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. Click Next >.
Appendix: Electrical Safety Gastric Pressure Characteristics 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 >.
Appendix: Electrical Safety Select Ileo-Cecal Junction 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.
Appendix: Electrical Safety Colonic Pressure Characteristics 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.
Appendix: Electrical Safety Select Body Exit Term Definition Body exit x x The time of the last temperature reading at body temperature, coinciding with an abrupt loss of capsule data. The time of the last abrupt rise in 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.
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.
Appendix: Electrical Safety Review Your Physiological Markers with MotiliGI¶V 0DUNHUV ► 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. Click Next >.
Appendix: Electrical Safety MotiliGI-Computed Capsule Ingestion MotiliGI determines ingestion by finding the point at which temperature stabilized at body temperature. 1. Follow the prompts. 2. Click Next >.
Appendix: Electrical Safety MotiliGI-Computed Gastric Emptying 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
Appendix: Electrical Safety Gastric Emptying Statistics This step allows you to enter observations about the gastric emptying statistics. ► Click Next >.
Appendix: Electrical Safety Gastric Emptying Time Evaluation Use GET to evaluate the patient’s gastric emptying function. ► 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. Click Next >.
Appendix: Electrical Safety MotiliGI-Computed ICJ 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 >.
Appendix: Electrical Safety Small Bowel Transit Time Evaluation The clinical significance of SmartPill’s transit time in the small bowel is unknown. ► Click Next >.
Appendix: Electrical Safety MotiliGI-Computed Body Exit 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.
Appendix: Electrical Safety Absence of Body Exit If you did not identify body exit, this step appears. x To review the computed body exit, click
Appendix: Electrical Safety Colonic Transit Time Evaluation 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 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.
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 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.
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.
Appendix: Electrical Safety A B Figure 9 - Ingestion 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 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.
Appendix: Electrical Safety Figure 12 - Body Exit
Appendix: Electrical Safety 0RWLOL*, )HDWXUHV 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.
Appendix: Electrical Safety Open – Open a test. You can choose to open by patient name or filename.
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.
Appendix: Electrical Safety 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. Test Status Icons Icon Description 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.
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.
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.
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.
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.
Appendix: Electrical Safety Creating Report Letterhead 1. Select Tools > Options > Report Tab. 2. Choose paper size. 3. Click Create Letterhead. x The Letterhead Creator appears: 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.
Appendix: Electrical Safety x To resize the image box drag your mouse to the desired size and click to apply. 6. Click Save. Files Tab 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.
Appendix: Electrical Safety 1. To access the patient information either: x Click on the toolbar x Click View > Patient Info. 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.
Appendix: Electrical Safety Method 2 ± Toolbar Icons ► Click on a “Show/Hide” data plot icon. Show/Hide Pressure Show/Hide pH Show/Hide Temperature 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 x To redo a view operation, click the toolbar icon. toolbar icon. MotiliGI prefers the physician-determined marker rather than the computed marker to define the regions.
Appendix: Electrical Safety 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.
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.
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.
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.
Appendix: Electrical Safety 7R PRYH DQ DQQRWDWLRQ¶V FDSWLRQ RQ WKH JUDSK 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.
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.
Appendix: Electrical Safety x (Optional) You can enter text in the Caption and Notes boxes. x You can click the checkboxes to show or hide the annotation and the caption. 2. Click OK. You can create and save multiple range annotations. ► To exit the Statistics mode, Click on the toolbar. The cursor returns to normal. To edit a range annotation: 1. Click on the toolbar. The cursor changes to . 2. Double-click the border of a range. The Range Annotation Editor screen appears. 3. Edit the annotation.
Appendix: Electrical Safety x Select Action > Generate Report The report opens in Microsoft WordPad. MotiliGI immediately saves the report to the patient’s folder using a default name. Caution Edits made to the WordPad report will not be saved to the MotiliGI test. To save the report: 1. Select File > Save As. 2. Type in a new name in File Name. 3. Click Save. Saving the Report as a PDF File 1. In WordPad, select File > Print. The Windows Print screen appears. 2.
Appendix: Electrical Safety 2. Name the folder. 3. Click Save. To Export the Entire Test 1. Select File > Export > Complete Test Data. A Save As screen appears x MotiliGI creates a folder that contains separate CSV files for pH, pressure and temperature. 2. Name the folder. 3. Click Save. To Export Individual Data Sets 1. Select File > Export > Customize Export. The Export Options screen appears. 2. Select the desired preferences.
Appendix: Electrical Safety Data Set Units pH pH units Pressure mmHg Temperature °C x Calibrated Data is converted data adjusted by the calibration point (pH 6, atmospheric pressure, room temperature). x Temperature Compensated is the calibrated data adjusted for sensor drift due to increased temperature. x Baseline Compensated is temperature compensated data with the baseline adjusted to 0. Exporting Images to JPEG or GIF You can export graphs to an image file in JPEG or GIF format.
Appendix: Electrical Safety 6\VWHP $GPLQLVWUDWRU 7RROV Password Management Logging into the System Computer For security purposes, after 5 unsuccessful attempts to logon, the user will not be allowed to logon for 15 minutes Enter the Windows user name and password noted below. User Name Password Privileges sgims1 12345 Can operate the computer and save documents. Can install programs, printers or change system settings by using MotiliGI Administrator.
Appendix: Electrical Safety Logging into MotiliGI When using MotiliGI for the first time, an administrator account is set up. The administrator has privileges to set up additional users and, edit user names and passwords. Forgotten Password If a user has forgotten his or her password, the administrator must log into MotiliGI and reset the user’s password. If the administrator has forgotten his or her username or password, they must call Technical Support.
Appendix: Electrical Safety Security enabled is the default setting and requires users to log in with their username and password. Security disabled eliminates the login (user authentication) step. The user will be logged into the default user account. Recommendation: Assign a unique username and password to each MotiliGI user. The username is used as the Technician Name in the printed report. Adding a User 1. Go to Tools > Options > Security. 2. Under User Management click Add. 3.
Appendix: Electrical Safety a. Confirm the files have been saved by opening the Removable Disk (E:) in Windows Explorer. b. Click (E:). located on the right side of the Start bar. Select Safely remove the Removable Disk Installing Software To install third-party software, log into the system computer as the system computer administrator – or –utilize SmartPill’s MotiliGI Administrator application. Caution Exercise caution installing third-party software (e.g.
Appendix: Electrical Safety Figure 15 Installing Software from a CD 1. Place the CD in the CD-ROM drive and click Update from CD. The contents of the CD will be displayed in the center box of the main screen. 2. Double click on the file you wish to install. Installing Software from a File on the System Computer Hard Drive 1. Locate the file you wish to install. 2. Move the file into C:\Program Files\SmartPill\ MotiliGI Administrator\Update\ Directory 3. Click Update from Folder.
Appendix: Electrical Safety Uninstalling MotiliGI Caution If you find it necessary to uninstall MotiliGI, ensure you have backed up and/or saved patient test files, exported data files and reports (except those that have been saved as PDFs) to another location on your hard drive or to external media (e.g., auxiliary or external hard drive, CD). You must be logged into the system computer as the Windows administrator to uninstall MotiliGI. 1. Backup any data files you have created. 2. Close MotiliGI. 3.
Appendix: Electrical Safety Figure 17 6. Double-click on the MotiliGI folder. 7. Double-click on Setup.exe. Follow all instructions in the installation wizard. 8. When the wizard finishes, close the wizard and close MotiliGI Administrator. 9. Reboot the PC. If you are installing MotiliGI on a computer other than your system computer (for reading test data only), you will need to install Adobe Acrobat Reader 7.0 or greater for MotiliGI to run properly.
Appendix: Electrical Safety $SSHQGL[ (OHFWULFDO 6DIHW\ External equipment intended for connection to signal input, signal output or other connectors shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment). In addition, all such combinations – systems – shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems.
*XLGDQFH DQG PDQXIDFWXUHU¶V GHFODUDWLRQ ± electromagnetic immunity The SmartPill GI Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the SmartPill GI Monitoring System should assure that it is used in such an environment.
GuidancH DQG PDQXIDFWXUHU¶V GHFODUDWLRQ ± electromagnetic immunity The SmartPill GI Monitoring System is intended for use in the electromagnetic environment specified below. The user of the SmartPill GI Monitoring System should assure that it is used in such an environment. Immunity test IEC 60601 test level Conducted 3 Vrms RF 150 kHz to IEC 61000- 80 MHz 4-6 3 V/m 80 MHz to 2.
Recommended separation distances between portable and mobile RF communications equipment and the SmartPill GI Monitoring System The SmartPill GI Monitoring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Device Classifications SmartPill pH.p Capsule SmartPill Data Receiver Power: Internally Powered Equipment Internally Powered Equipment Class I Equipment Electric Shock Protection: Type BF Applied Part Type BF Applied Part Ordinary Equipment Harmful Ingress Water: Watertight Equipment (IP57) Ordinary Equipment Ordinary Equipment Equipment not suitable for use in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE.
Accessories, 6 Activation Fixture, 5 Adverse Events, 13 Body Exit, 63, 82 Capsule Activation, 32 Confirming Exit, 45 Deactivating, 41 Low Voltage, 62 Operational Specifications, 2 Pack, 2 Power Requirements, 11 Tray Orientation, 36 Capsule Ingestion, 50 Chronic constipation, 9 Colonic transit time, 9 Combined small and large bowel transit time, 9 Contraindications, 10 CTT. See Colonic transit time Data Display.
Date, Time, Language and Regional Options, 17 Logging in, 109 Power Requirements, 10 Requirements, 6 Set up, 17 Templates Creating, 30 Using, 30 Test Analyzing, 49 Downloading, 43 Test Analysis Wizard, 47 Test Initiation Wizard, 27 Test Summary Reports, 76 Troubleshooting and Support, 15 User Preferences, 90 WGTT.
Contacting Given Imaging USA & Headquarters of the Americas France Given Imaging, Inc. Given Imaging France S.A.S. 3950 Shackleford Road, Suite 500 22, Rue Guynemer Duluth, GA 30096, USA 78600 Maison-Laffitte Phone: 770-662-00870 Paris, France Toll-Free: 1-800-GIVENGI Phone: +33 (0) 1 34 93 80 00 Fax: 770-662-0510 Fax: +33 (0) 1 34 93 80 11 USA: supportUS@givenimaging.com supportFR@givenimaging.com Latin America: supportLA@givenimaging.
This manual and the compilation of the content in this manual, including but not limited to text, graphics, logos and images, is the exclusive property of Given Imaging and is protected by United States and international copyright laws. This manual may not be transferred in any form without permission of Given Imaging. Copyright © 2006-2013 Given Imaging. All Rights Reserved. The SmartPill logo, “The Measure of GI Health” and “MotiliGI,” are trademarks of Given Imaging.
