Dexcom Pro Q User Manual
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Dexcom Pro Q User Manual

Dexcom Pro Q User Manual

Continuous glucose monitoring system
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Continuous Glucose
Monitoring System
User Guide
Insertion p 21
Removal p 31

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Summary of Contents for Dexcom Pro Q

  • Page 1 Continuous Glucose Monitoring System User Guide Insertion p 21 Removal p 31...
  • Page 3 WARNING: Please review the product instructions before using the Dexcom Pro Q Continuous Glucose Monitoring System (Pro Q). Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Pro Q.

  • Page 4: Table Of Contents

    Dexcom Pro Q . . . . . . . . . . . . . . . . . . .

  • Page 5: Part 1: System Overview

    System Overview • Introduction • Indications for Use and Safety Statement • Risks and Benefits...

  • Page 6: Introduction

    Dexcom Pro Q is blinded; the participant won’t see their current readings. However, the readings are recorded and are downloaded later. An authorized data extraction tool downloads glucose data after a sensor session. See dexcom.com/guides for instruction related to data extraction.
  • Page 7 The transmitter snaps into the transmitter holder and records glucose information. Transmitter: • Stores sensor readings for future analysis • One use only • Water resistant Chapter 4 has more information on sensor insertion and transmitter attachment. Dexcom Pro Q ™ System User Guide Chapter 1: System Overview...

  • Page 8: Resources

    Pro Q removal. User Guide This User Guide is an encyclopedia of Pro Q knowledge. It provides an overview of the Dexcom Pro Q, detailing features, important safety information, and more. Download the User Guide or ask for a printed version: •...

  • Page 9: Glossary

    Sensor inserted under the skin checks glucose levels in interstitial Glucose Reading fluid. A transmitter stores readings to be retrieved later. Situations in which the Pro Q shouldn't be used because it may be Contraindication harmful to the user. Default Preset option for a device setting.
  • Page 10 Milligrams per deciliter. The standard unit of measure for BG mg/dL readings in the United States. Precaution Special care for the safe and effective use of the Pro Q. Safety Intended uses of Pro Q and relevant warnings, precautions, and Statement contraindications.

  • Page 11: Chapter 2 | Indications For Use And Safety Statements

    Dexcom Pro Q sensor glucose readings (Dexcom Pro Q readings). Warnings • Do not use the Dexcom Pro Q if participant is pregnant, on dialysis, or critically ill. It is not known how different conditions or medications common to theses populations may affect performance of the system.
  • Page 12 • Some skin care products, such as sunscreens and insect repellents, can make the plastic used in the Dexcom Pro Q crack. Before using the Dexcom Pro Q, make sure there are no cracks in the transmitter, and transmitter holder. If there is a crack, Dexcom Pro Q ™...
  • Page 13 Technical Support. Do not allow these skin care products to contact the Dexcom Pro Q. After using skin care products, wash hands before touching the Dexcom Pro Q. If any skin care products get on the Dexcom Pro Q, immediately wipe with a clean cloth.

  • Page 14: Chapter 3 | Risks And Benefits

    1 gram (1,000 mg) every 6 hours. Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the Dexcom Pro Q readings and make them look higher than they really are. Dexcom Pro Q ™...

  • Page 15: Benefits

    • Reviewing historical glucose levels Knowing Your Trends The Dexcom Pro Q records a glucose reading every 5 minutes for up to 10 days. After the wear period, it will provide reports and views of a participant's glucose information so they can identify and reflect on trends, patterns, and how their body responds to different things, like exercise or pizza.

  • Page 16: Part 2: Insertion & Removal

    Insertion & Removal • Insertion • Removal...

  • Page 17: Introduction

    • Attach transmitter to transmitter holder 4.2 Prepare to Insert Sensor Before inserting a sensor, gather: Dexcom Items (confirm both boxes are Pro Q): • Sensor pack – Check expiration date on sensor. Don’t use if expired. – Don’t open the sensor until ready to insert the sensor.
  • Page 18 • Don't use bony sites, such as over the ribs • Don't use sites where sensor can be rubbed – by a belt, waist band, seat belt strap – or lain on while sleeping Dexcom Pro Q ™ System User Guide...
  • Page 19 PRECAUTION Where to Insert: Things to Check Keep the safety guard on until the Pro Q applicator has been placed against skin. If the safety guard is removed first, someone may get hurt by accidentally pushing the button that inserts the sensor before it is ready.

  • Page 20: Insert Sensor

    Remove when ready to insert sensor Button Inserts sensor under the skin Sensor Sensor inserts through this hole Adhesive Keeps sensor and transmitter holder on skin Transmitter Holder Transmitter snaps in Dexcom Pro Q ™ System User Guide Chapter 4: Insertion...
  • Page 21 Make sure to use the same Mastisol or Skin Tac™. applicator. Peel off cover. ® • Let skin adhesive dry. Check sensor for damage. • Insert sensor on clean skin in center of oval. Dexcom Pro Q ™ System User Guide Chapter 4: Insertion...
  • Page 22 Place applicator horizontally on participant's skin. Don’t touch adhesive. Firmly press down, sticking adhesive to the skin. Fold and break safety guard and Push and release button to throw it away. insert sensor. Dexcom Pro Q ™ System User Guide Chapter 4: Insertion...
  • Page 23 – redness, swelling, or pain – appear at the insertion site. Having problems? Have questions or need help? Contact Technical Support at: • Phone: Available Monday – Friday, 6:00 AM – 6:00 PM Pacific Time • Toll free: 1.844.857.6319 Dexcom Pro Q ™ System User Guide Chapter 4: Insertion...

  • Page 24: Attach Transmitter

    • Don't scratch it – that may harm the waterproof seal Slide transmitter tab into the slot at Press the wide end of the transmitter the narrow end of the holder. until it clicks into the holder. Dexcom Pro Q ™ System User Guide Chapter 4: Insertion...
  • Page 25 (brand names include Blenderm™, Tegaderm™, Smith & Nephew IV3000 ® 3M™ tape) for extra support. Order overpatches at dexcom.com/order. Tips for putting on the overpatch or extra adhesive tape: • Put overpatch or tape over white patch on all sides for even support •...

  • Page 26: Chapter 5: Removal

    Bend holder edge down to Put on gloves.  break it and release the transmitter. Pull patch off like a bandage. The transmitter, holder, and sensor all come off with the patch. Dexcom Pro Q ™ System User Guide Chapter 5: Removal...
  • Page 27 Pull transmitter straight out. Place transmitter and transmitter holder into bag and seal. Send bag to program administrator for data extraction. See dexcom.com/guides for instruction related to data extraction. Dexcom Pro Q ™ System User Guide Chapter 5: Removal...

  • Page 28: Part 3: Troubleshooting

    Troubleshooting • Introduction • Applicator • Sensor...

  • Page 29: Chapter 6 | Troubleshooting

    • Toll Free: 1.844.857.6319 6.2 Applicator Orange Button Stuck Problem Can’t push the applicator orange button in Solution • Fold and break off safety guard before pushing orange button • See Chapter 5 Dexcom Pro Q ™ System User Guide Chapter 6: Troubleshooting...
  • Page 30 • Before applying sensor: Use an optional skin adhesive (such as Mastisol or Skin ® Tac™) • After applying sensor: Put overpatch or tape over patch • Order overpatches at dexcom.com/order Dexcom Pro Q ™ System User Guide Chapter 6: Troubleshooting...
  • Page 31 • Tape brand names include Blenderm, Tegaderm, Smith & Nephew IV3000, and 3M • See Chapter 5 Applying Overpatch Applying tape Dexcom Pro Q ™ System User Guide Chapter 6: Troubleshooting...
  • Page 32 • Remove applicator and adhesive patch: 1. Gently pull applicator up until adhesive patch is seen 2. Using a finger or thumb, hold front edge of patch and peel from skin Dexcom Pro Q ™ System User Guide Chapter 6: Troubleshooting...

  • Page 33: Sensor

    Don’t ignore broken or detached sensor wires. A sensor wire could remain under participant's skin. If this happens, please contact Dexcom 24/7 Technical Support. If a sensor wire breaks off under participant's skin and it can't be seen, don’t try to remove it.
  • Page 34 • Nothing is rubbing against transmitter holder, like a seatbelt or waistband • Insertion site is clean and dry before sensor insertion • Transmitter is snapped securely in transmitter holder • Transmitter holder isn’t dislodged and patch isn’t peeling Dexcom Pro Q ™ System User Guide Chapter 6: Troubleshooting...

  • Page 35: Part 4: Appendices

    Appendices • Support Teams • Security and Air Travel • Care of Dexcom Pro Q • Warranty • Technical Information • Label Symbols • Index...

  • Page 36: Appendix A | Support Teams

    Appendix A Support Teams Dexcom has three support teams to help, each with their own specialty: • Dexcom Technical Support Team • Dexcom Patient Care Team • Dexcom Sales Support Team A.1 Dexcom Technical Support Team This team assists with all system-related issues as well as software-related issues.
  • Page 37 A.2 Dexcom Patient Care Team The Dexcom Patient Care Team is a group of Certified Diabetes Educators (CDE) and Registered Nurses (RNs) offering customer care and individualized education services around Dexcom Pro Q, including: • Product training – both initial and ongoing (for example, how to use a specific feature) •...

  • Page 38: Appendix B | Security And Air Travel

    Appendix B Security and Air Travel The Dexcom Pro Q can be a great travel companion – a participant can go through metal detectors and hand-wanding. B.1 Security Going through security often means a person and their belongings go through a metal detector, x-ray machine, or even a body scanner.
  • Page 39 PRECAUTION Going Through Security Checkpoint When wearing a Dexcom Pro Q, ask for hand-wanding or a full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner (also called a millimeter wave scanner). A Dexcom Pro Q can be worn for the walk-through metal detector.

  • Page 40: Dexcom Pro Q

    • Transmitter is water resistant • Don’t use lotions, sunscreen, insect repellent, or similar items on the transmitter C.2 System Disposal Follow your area’s local waste management requirements. Dexcom Pro Q ™ System User Guide Appendix C: Care of Dexcom Pro Q...

  • Page 41: Appendix D | Warranty

    What’s Covered and for How Long? Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser (“you” or “Purchaser”) that the Dexcom Pro Q transmitter (the “transmitter”) is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing on the date of first use by the original purchaser (the “Date of...

  • Page 42: Appendix E | Technical

    • Installation, maintenance, and service of products or services other than the CGM system (which may be subject to a separate limited warranty), whether provided by Dexcom or any other party; this includes your cell phone or smart device and your connection to the Internet.

  • Page 43: Appendix E | Technical

    Dexcom Pro Q or any feature or service provided by Dexcom for use with the Dexcom Pro Q.
  • Page 44 Limited Warranty. This Limited Warranty will be enforced to the maximum extent permitted by law. Dexcom Pro Q ™ System User Guide Appendix D: Warranty...

  • Page 45: Information

    E.1 Device Performance Characteristics NOTE: The device performance described in this section are from studies conducted for the Dexcom G6 CGM System (G6). The performance of the G6 is relevant because the Dexcom Pro Q System uses the same sensor and transmitter.
  • Page 46 In Study 2, participants managed their glucose as they normally do; glucose was not deliberately manipulated. The data from these prospective clinical studies were further processed and analyzed at Dexcom to assess performance of factory calibration. Accuracy Accuracy of the G6 is characterized by assessing its readings against blood glucose values from YSI.
  • Page 47 99.5 -0.5 11.5 70-180 9,453 74.1 86.8 99.3 -2.8 10.9 181-250 4,093 80.2 92.1 99.9 -10.0 >250 3,863 91.1 97.7 100.0 -3.8 CGM readings are within 40-400 mg/dL, inclusive. Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 48 96.5 99.8 * Includes pediatric subjects 6-17 years of age; no YSI measurements were taken for pediatric subjects 2-5 years of age. CGM readings are within 40-400 mg/dL, inclusive. Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 49 88.2 95.9 99.8 15.8 54-69 1,783 88.8 96.1 99.9 12.4 70-180 8,713 76.8 89.0 99.6 -0.8 10.3 181-250 3,940 83.0 92.7 99.8 -7.2 >250 4,410 83.4 93.3 99.8 -13.5 Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 50 84.9 94.9 99.6 -1.4 >250 85.4 95.8 100.0 -3.9 * Includes pediatric subjects 6-17 years of age; no YSI measurements were taken for pediatric subjects 2-5 years of age. Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 51 3. When the G6 CGM rate of change is stable (≥ -1 mg/dL/min and ≤ 1 mg/dl/ min), how often is glucose changing rapidly (≥ 2 mg/dL/min or ≤ 2 mg/dl/ min)? The answer is only 1.9% of the time. Dexcom Pro Q ™ System User Guide...
  • Page 52 76.9% 12.5% 0.6% 0.1% 7,986 [0,1] 0.1% 1.0% 26.2% 60.6% 10.6% 1.6% 5,199 (1,2] 0.0% 0.4% 3.1% 26.8% 52.9% 16.8% 1,734 >2 0.1% 0.1% 0.8% 5.6% 22.1% 71.3% 1,367 Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 53 (MARD) shows the average amount the sensor readings differ from the YSI glucose. The MARD values included in Table 3-A and 3-B show consistent accuracy and sensor stability over the 10-day life of the sensor. Dexcom Pro Q ™ System User Guide...
  • Page 54 91.1 98.5 * Includes pediatric subjects 6-17 years of age; no YSI measurements were taken for pediatric subjects 2-5 years of age. CGM readings are within 40-400 mg/dL, inclusive. Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 55 1-B). Among the 210 sensors evaluated, 28 sensors (13.3%) had “early sensor shut- off” where the sensor algorithm would have detected sensors that did not function as intended and shut them off. Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 56 Number of Sensors Survival Rate (%) 99.4% 98.8% 98.8% 98.8% 98.1% 98.1% 96.8% 96.2% 94.9% 139* 93.5% * Includes sensors that survived more than 9.5 days (228 hours) of wear. Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 57 Figure 1-A. Kaplan Meier Curve of Sensor Life (Adults; N = 164) Note: “# of Censored” refers to sensors excluded from the survival analysis due to reasons not related to the device (e.g., subject dropped out of study) Dexcom Pro Q ™ System User Guide...
  • Page 58 Number of Sensors Survival Rate (%) 99.0% 99.0% 97.1% 95.6% 91.1% 88.6% 85.5% 83.4% 79.2% 142* 76.8% * Includes sensors that survived more than 9.5 days (228 hours) of wear. Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 59 For the G6 with auto-applicator, approximately 99% of the sensors captured readings every 5 minutes at least 90% of the time. Table 5 below describes the reading captured rate by each wear day over the sensor life. Dexcom Pro Q ™ System User Guide...
  • Page 60 Table 5. Reading Capture Rate by Wear Day (n=374) Wear Day Number of Sensors Capture Rate (%) 97.6 98.6 98.7 98.6 98.5 98.5 98.2 97.8 97.0 96.4 Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 61 G6 CGM System configuration. The automatic applicator was designed to provide more consistent sensor insertions. The data from Study 2 was also further processed at Dexcom to assess performance of factory calibration. The G6 Glucose Program CGM System uses the automatic applicator and does not require calibration by the user.
  • Page 62 Number of subjects (n) Percent (95% LB) Comfort: Painless (mild, no pain) Ease of use: easy 100% (somewhat or very) IFU ease of use: easy 100% (somewhat or very) Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 63 Temperature: 36° F – 86° F Storage and Transport Conditions Store sensors in a cool, dry place Sterilization Sterile by radiation Transmitter Product Specifications Part # 9445-19 Memory Storage Electrical Safety Class Internally Powered Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 64 Alarm Audible Output TX/RX Frequencies 2.402 – 2.480 GHz Bandwidth 1.07 MHz Maximum Output Power 1.0 mW EIRP Modulation Gaussian Frequency-Shift Keying Data Rate 1 Mbps Communication Range 20 feet Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...
  • Page 65 Security Measures After completion of a sensor session, the Dexcom Pro Q System is designed to transmit data between the transmitter and authorized data extraction device in accordance to the industry standard BLE protocols. It will not accept radio frequency (RF) communications using any other protocol, including Bluetooth classic communication protocols.
  • Page 66 Electromagnetic interference can still occur in the home health care environment as control over the EMC environment cannot be guaranteed. An interference event can be recognized by gaps in G6 readings or gross inaccuracies. Dexcom Pro Q ™ System User Guide...
  • Page 67 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. G6 transmitter FCC ID: PH29588 Dexcom Pro Q ™ System User Guide Appendix E: Technical Information...

  • Page 68: Appendix F | Label Symbols

    Symbols may be found on the sensor and transmitter package. These symbols refer to the proper and safe use of the Dexcom Pro Q. This table shows what each symbol means. They are also found in the Symbols Glossary at dexcom.com/symbols.
  • Page 69 IP22: Protection Against Insertion of Large Objects and Dripping Water IP28: Protection Against Insertion of Large Objects and Immersion in Water Keep Away from Heat Keep Dry Manufacturer MR Unsafe Dexcom Pro Q ™ System User Guide Appendix F: Label Symbols...
  • Page 70 Non-Ionizing Radiation Part Number Prescription Required Refer to Instruction Manual/Booklet Serial Number Ship-By Date Sterile by Radiation STERILE R Temperature Limitation Type BF Applied Part Use By Date Dexcom Pro Q ™ System User Guide Appendix F: Label Symbols...

  • Page 71: Index

    Warranty, 39 Indications, 9 Warnings, 9 Sensor Session Attaching transmitter, 22 Definition, 8 Inserting sensor, 18 Insertion site, 10, 11, 16, 17 Prepping for sensor insertion, 15 System Components, 4 Technical Information, 43 Dexcom Pro Q ™ System User Guide Index...
  • Page 72 Covered by patents dexcom.com/patents. Dexcom, Dexcom Follow, Dexcom G4 PLATINUM, Dexcom G5, Dexcom G6, Dexcom Share, G6, Dexcom Pro Q, Pro Q, are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. Bluetooth is a registered trademark owned by Bluetooth SIG.
  • Page 73 Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA Tech Support: 1.844.857.6319 Web: dexcom.com LBL016581 Rev 003 © 2018 Dexcom, Inc. All rights reserved.

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