ML19330D851
| ML19330D851 | |
| Person / Time | |
|---|---|
| Site: | 07003103 |
| Issue date: | 11/21/2019 |
| From: | Cowne S Louisiana Energy Services, URENCO USA |
| To: | Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation |
| References | |
| LES-19-166-N RC | |
| Download: ML19330D851 (22) | |
Text
LES-19-166-N RC NOV 2 1 2019 USA Attn: Document Control Desk Office of Nuclear Security and Incident Response U.S. Nuclear Regulatory Commission The National Enrichment Facility Washington, DC 20555-0001 Louisiana Energy Services, LLC NRC Docket No. 70-3103
Subject:
Request for Approval of Use of Glucose Monitor in Classified Areas
References:
- 1. Letter from J Zimmerman to W Padgett regarding approval of medical transmitting devices dated 12/14/2018 (IN-18-161-NRC)
- 2. Letter from J Zimmerman to R Medina regarding approval of hearing aids dated 6/21/2019 (IN-19-067-NRC, ML19164A079)
Pursuant to Reference 1, Louisiana Energy Services, also dba URENCO USA (UUSA) herewith requests approval of a personal wireless medical device to be worn in areas designated for storage of classified information.
The device is a Dexcom G6 Continuous Glucose Monitoring System. An individual will wear the sensor and transmitter within the closed area. The transmitter is capable of pairing and communicating with either a smartphone, dedicated receiver, or both. A summary of the device is enclosed.
In addition to the sensor and transmitter, UUSA request that the dedicated receiver (but not a paired smartphone) be allowed in the closed area. This will provide for the individual to read the glucose level, hear alarms and make treatment decisions while within the closed area.
UUSA requests approval of the device such that additional users of the same device model do not require separate NRC approval. UUSA currently has one individual needing approval for this device. Similar to the stipulations described in Reference 2, UUSA agrees to the following;
- 1. UUSA will maintain a record of each individual approved for the use of the Dexcom G6 medical device.
- 2. For each individual, the cell phone connected via Bluetooth will be disconnected prior to the medical device being taken into the "closed area."
If you have any questions, please contact Scott Diggs, Acting Licensing and Performance Assessment Manager at 575-394-6203.
Respectfully,
~*'-*0,':,1Afj p.,,.
Stephen Cowne Chief Nuclear Officer and Compliance Manager
Enclosure:
- 1. Dexcom G6 Device Summary I
Louisiana Energy Services, LLC UUSA I P.O. Box 1789 1 Eunice I New Mexico I 88231 I USA T: +1 (575) 394 4646 I W: www.uusa.urenco.com
LES-19-166-NRC cc:
J. Keith Everly, Senior Program Manager U.S. Nuclear Regulatory Commission JKeith.Everly@NRC.gov Kevin Ramsey, Senior Project Manager U.S. Nuclear Regulatory Commission Kevin.Ramsey@NRC.gov
LES-19-166-NRC ENCLOSURE 1 Dexcom G6 Device Summary
oexcomG6" START HERE Set up 0
Display Device
- Shows glucose information
- Set up your smart device, Dexcom receiver, or both
- For a list of current compatible smart devices and operating systems go to:
dexcom.com/compatibility Applicator With Built-in Sensor
- Sensor applicator inserts sensor under your skin
- Sensor gets glucose information Transmitter
- Sends glucose information from sensor to display device Your smart device All graphics are representational. Your product may look different.
Dexcom receiver Review the Safety Statement in Using Your G6, Appendix E before using your G6.
The G6 sends G6 sensor glucose readings (G6 readings) to your display device.
Choose App, Receiver, or Both The receiver is a dedicated medical device. Your smart device isn't, even though you can run the G6 app on it. Why? Because the app could miss an alarm/alert just because it's on a smart device
- for example, due to smart device settings, smart device or app shutting off, low battery, etc.
Use tabs below to set up the app, receiver, or both Want to set up both? Pick one to set up first and turn to that tab.
The last step shows you how to set up the second display device.
Do not use both tabs.
For other ways to learn how to set up your G6:
- Watch the tutorial online at: dexcom.com/guides
- Contact Dexcom Care for individualized support or to register for free, online webinars at: dexcom.com/dexcom-care or 1.888.738.3646
- For Technical Support, go to dexcom.com/tech-support, or call 1.888. 738.3646 (Toll free) or 1.858.200.0200 (Toll).
Your smart device Dexcom receiver
Applicator with Built-in Sensor Your smart device Transmitter
A Download and open the Dexcom app lillllii......
GETITON
,..... Google Play B Follow onscreen setup instructions 1
When prompted, enter your:
- Sensor code from the sensor applicator No sensor code?
See Using Your G6, Appendix A Troubleshooting BXXXX
Serial Number (SN) from:
Transmitter box Back of transmitter After you enter your SN, your G6 searches for the transmitter. While it's searching, you won't get G6 readings or alarm/alerts.
2 See the blue sensor warmup timer?
That means your sensor is getting used to your body.
During warmup:
- No G6 readings or alarm/alerts
- Always keep smart device within 20 feet of transmitter C Wait 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />
- When complete, tap OK to see the home screen
- Now you get G6 readings and alarm/alerts
Your smart device isn't a dedicated medical device. To make sure you always get your readings and alarm/alerts, use this safety information:
System Safety
- Don't rely on the G6 until you understand how to use it and your smart device's 8/uetooth. 8/uetooth must be on for your transmitter and app to communicate. Read product instructions before using the G6.
App Safety
- If the smart device or G6 app closes or isn't working, you won't get readings or alarm/alerts. Occasionally check that the G6 app is open and Bluetooth is on.
Smart Device Safety
- The app uses the smart device battery. Keep it charged to get readings and alarm/alerts.
- When using Bluetooth or plug in headphones, speakers, etc., test to find out where your alarm/alerts will sound. They might sound on your smart device, on the headphones/speakers/etc, or on both. Each product is different.
- Occasionally, your smart device will ask you to upgrade your operating system (OS).
Before upgrading, verify the new OS has been tested with the app at dexcom.com/compatibility. Always update the OS manually and verify correct device settings afterward. Automatic updates of the app or your device OS can change settings or shut down the app. You must have an Internet connection to upgrade.
- Make sure your smart device speaker(s) and screen work.
- Don't use a hacked (jailbroken or rooted) smart device because G6 may not work correctly on it.
- Apple: If smart device is on silent/Do Not Disturb you won't get the Signal Loss Alert.
- Android: If smart device sound is on most restrictive setting no alarm/alerts sound.
For more information on day to day life with your G6, see Using Your G6.
Turn on the receiver by pressing the power button down for 2-3 seconds. Then follow onscreen instructions.
Don't use the Set Up Receiver tab. Those steps are for setting up the receiver before setting up the app.
Applicator with Built-in Sensor Receiver Transmitter
A Take receiver out of box B Turn on receiver Press and hold power button for 2-3 seconds C Follow onscreen instructions 1 When prompted, enter your:
- Sensor code from the sensor applicator you will insert No sensor code?
See Using Your G6, Appendix A Troubleshooting
Serial Number (SN) from:
Transmitter box Back of transmitter After you enter your SN, your G6 searches for the transmitter. While it's searching, you won't get G6 readings or alarm/alerts.
2 You're done with this step when you see this screen:
A Take applicator with built-in sensor out of sensor box Gather materials: applicator (with code you just entered), transmitter, and wipes.
B Pick sensor site 18 years and older 2-17 years Look for a place on your belly or upper buttocks where you have some padding.
Avoid bones, irritated skin, tattoos, and areas that get bumped.
C Use applicator to insert built-in sensor 1 Wash and dry hands. Clean sensor site with alcohol wipe.
2 Peel off adhesive backings.
Do not touch adhesive.
3 Place applicator on skin.
5 Press button to insert sensor.
7 Throw away applicator.
Follow local guidelines for blood-contacting components.
4 Fold and break off safety guard.
6 Remove applicator from skin leaving patch and holder on.
A Take transmitter out of box B Snap in transmitter 1 Clean transmitter with alcohol wipe.
3 Snap in transmitter. It clicks into place. Make sure it is flat and snug in holder.
2 Insert transmitter, tab first, into holder.
4 Rub around patch 3 times.
/
/
A Wait up to 30 minutes for pairing During pairing:
No G6 readings or alarm/alerts
- Always keep receiver within 20 feet of transmitter B Tap Start Sensor to begin 2-hour warmup During warmup you won't get G6 readings or alarm/alerts C Wait 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />
- When complete, tap Next to go to home screen
- Now you get G6 readings and alarm/alerts
Learn how to:
- Read your home screen
- Use alarm and alerts
- Make treatment decisions
- Troubleshoot issues Download the app onto your smart device and open it.
Then follow onscreen instructions.
Don't use the Set Up App tab. Those steps are for setting up the app before setting up the receiver.
oexcom
oexcom
© 2019 Dexcom, Inc. All rights reserved.
Covered by patents dexcom.com/patents.
Dexcom, Dexcom G4, Dexcom GS, Dexcom G6, Dexcom Share, Share, Dexcom Follow, Dexcom CARE, and Dexcom CLARITY 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, Inc. Apple is a registered trademark owned by Apple Inc. Android is a registered trademark owned by Alphabet Inc. All other product or company names that may be mentioned in this publication are trade names, trademarks, or registered trademarks of their respective owners.
oexcom Dexcom, Inc.
6340 Sequence Drive San Diego, CA 92121 USA Phone: 1.858.200.0200 Tech Support: 1.888.738.3646 Web: dexcom.com LBL015751 Rev 005 MT24964