Rightest iFree CGM User Manual

Continuous glucose monitoring system

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Download this manual

145*80 mm

BIONIME CORPORATION

No. 100, Sec. 2, Daqing St., South Dist.,

Taichung City 40242, Taiwan

Tel: +886 4 2369 2388

Fax: +886 4 2261 7586

Email: info@bionime.com

http://www.bionime.com

Made in Taiwan

Emergo Europe B.V.

Westervoortsedijk 60

6827 AT Arnhem

The Netherlands

Email: EmergoVigilance@ul.com

0197

CONTINUOUS GLUCOSE MONITORING SYSTEM

User's Manual

For use with mobile App or a receiver

Table of Contents

Need help?

Do you have a question about the iFree CGM and is the answer not in the manual?

Questions and answers

Summary of Contents for Rightest iFree CGM

Page 1 145*80 mm CONTINUOUS GLUCOSE MONITORING SYSTEM BIONIME CORPORATION User's Manual No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan For use with mobile App or a receiver Emergo Europe B.V. Tel: +886 4 2369 2388 Fax: +886 4 2261 7586 Westervoortsedijk 60 Email: info@bionime.com 6827 AT Arnhem...
Page 3: Table Of Contents
INDICATIONS FOR USE & STATEMENT AND ADVISORY READ THIS FIRST : It is important to read the entire contents of this manual before using the RIGHTEST iFree INDICATIONS FOR USE Continuous Glucose Monitoring System. The instructions, warnings, precautions, safety STATEMENT AND ADVISORY...
Page 4 SCAN THE SENSOR KIT AND TRANSMITTER WHEN NOT TO USE SENSOR READINGS TO MAKE TREATMENT DECISIONS APPLY YOUR SENSOR TREND ARROWS AND TREATMENT DECISIONS ATTACH YOUR TRANSMITTER SPECIFICATIONS CONNECT TRANSMITTER WITH DISPLAY DEVICE SENSOR KIT SPECIFICATIONS ENDING A MONITORING SESSION TRANSMITTER SPECIFICATIONS END THE MONITORING SESSION RECEIVER SPECIFICATIONS...
Page 5: Indications For Use & Statement And Advisory
CGMs. WARNING indicates potential danger to the user. PRECAUTION indicates potential injury The RIGHTEST iFree Continuous Glucose Monitoring System (hereafter referred to as the to the user or damage to the system. To minimize risks, read the following safety information before "iFree CGMs") is indicated for detecting glycemic trends and for the management of diabetes in...
Page 6 WARNINGS : Not receiving Urgent Alarms Under The Following Conditions: Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following • When either your display device or transmitter battery is dead. Conditions: • When your display device is turned off. •...
Page 7 PRECAUTIONS : Do not freeze sensors. Avoid direct sunlight, extreme temperatures, and high humidity. Calibration Safety: Otherwise, only use fingerstick blood glucose values to calibrate These conditions may damage the sensor and cause inaccurate sensor readings. your system for accurate readings. Entering incorrect fingerstick blood glucose values or DO NOT Reuse Your Sensor or Inserter: The entire Sensor Kit package is sterilized blood glucose values taken from testing at other places can result in inaccurate glucose and designed for single use.
Page 8 Notify the security personnel of the presence of the iFree CGMs and comply with contact your healthcare professional or Customer Service. requirments for pat-downs, visual inspection and metal detectors. You must comply with Be Careful of Electromagnetic Disturbance: Stacking equipment, or using AC power any requests by airline personnel (e.g.
Page 9: Symbol Definitions
SYMBOL DEFINITIONS The following symbols apply to the iFree CGMs: Humidity limitation Medical Device Do not use if the package is Method of sterilization using Date of Manufacture Keep Dry damaged irradiation Manufacturer Biological risks Serial number MR Unsafe Authorized representative in the CE Mark with Notified Body For single use only Prescription Required...
Page 10: Getting To Know Your Ifree Cgms
GETTING TO KNOW YOUR IFREE CGMS Discard this product according to Keep away from heat PERFORMANCE FEATURES local regulations The iFree CGMs is an integrated continuous glucose monitoring system (iCGM) that provides glucose readings, trends, and levels every minute. Near-field communication Importer (NFC) scan area The iFree CGMs has user-friendly features and benefits including:...
Page 11: Safety Features
SAFETY FEATURES TRANSMITTER (HT312) The iFree CGMs offers a number of important safety features when you use it. The transmitter wirelessly sends your glucose data from the These features include: sensor to the display device. • Alarms and alerts includes visual notification, vibrations and sound, depending on your The transmitter is rechargeable for multiple-use by a single personalized settings.
Page 12: Accessories
ACCESSORIES BEFORE YOU START INSTALL THE MOBILE APP iFree CGMs Mobile App can be downloaded from the Google play store or App Store. Start by TRANSMITTER CHARGER (HC312) following the on-screen instructions to complete the initial setup if it is your first time using the App. The screens in this manual may look different from your App because of operating systems or A USB charging dock is included.
Page 13: Charging The Receiver
iFree CGMs Mobile App is only compatible with certain smartphones and operating systems, please check the official website or contact customer service for more information about compatible devices. CHARGING THE RECEIVER Before using the system for the first time, charge the receiver for a complete charging cycle without 1.
Page 14: Charging The Transmitter
CHARGING THE TRANSMITTER WARNINGS : Not Receiving Alarms or Alerts. There are no alarm or alerts when your transmitter battery is dead. PRECAUTIONS : Plug in to Charge. Make sure to fully charge your transmitter before you start a new monitoring session.
Page 15 3. Plug the cable’s USB plug into the USB port on the AC power adapter. 2. Connect the USB-C Plug of the charging cable to the USB-C input of the charger. Slide the USB-C port inwards to lock the transmitter in position.
Page 16 5. Unplug the cable from the power adapter after the transmitter is fully charged. 7A. To start in a new monitoring session, slide the fully charged transmitter out of the 6. Pull the USB-C cable outwards to allow the compartment. transmitter to be removed.
Page 17: Setting Up Your Ifree Cgms
SETTING UP YOUR IFREE CGMS Before setting up your iFree CGMs, make sure you have everything you need: • Sensor Kit • Transmitter • Display device (Choose one between a smartphone with the mobile App or the receiver) • Alcohol Wipes •...
Page 18 The following steps describe how to start a monitoring session. If you are unable to start a monitoring session please contact Customer Service. 1. Open the mobile App on your smartphone. 2. Tap [Let’s Started] to start a new glucose monitoring session. 3.
Page 19 Receiver: Android 1. Get your receiver. 2. If your receiver is OFF, press and hold the [Power] button for 2 seconds to turn it ON. If your receiver is ON, press the [Power] button briefly to wake up the display. NOTE : If using the receiver for the first time, follow prompts to set the date, time and your glucose targets and...
Page 20 5. Scan the transmitter by touching it with the back of your receiver until you hear a beep. 3. Tap [New Monitor] to start a new monitoring NOTE : session. Make sure the NFC panel is within 1 cm (3/8”) of the NFC tag when you scan it.
Page 21 7. Scan the Sensor Kit by touching its NFC tag (on 9. When the receiver displays "Ready to Insert", the top of package) with the back of your receiver check whether the serial numbers of the sensor until you hear a beep. and the transmitter match those labeled on the NOTE : package.
Page 22: Apply Your Sensor
APPLY YOUR SENSOR The sensor is pre-loaded inside the inserter. Before applying the sensor to your skin, familiarize yourself with the information in this section. Overview of the Sensor Kit Sensor Inserter Sensor: Cap: Inserts into your skin Open before insertion Choose an insertion site on the back Sensor Base: Adhesive Patch:...
Page 23 Sensor base is parallel to your Sensor base is NOT parallel to your The following areas are preferable for insertion: upper arm upper arm 1. Skin that stays flat during normal daily activities (without bending or folding). 2. An area unlikely to be bumped, pushed, or lain on while sleeping. The following should NOT be selected for insertion: 1.
Page 24 2. Wipe the insertion site with an alcohol wipe and wait for approximately 2 minutes until the site has dried before getting started. NOTE : 1. Wash and dry your hands. 1. Cleaning the insertion site using a plain soap, drying, and then cleaning with an alcohol wipe before insertion of a sensor helps remove any oily residue to let the sensor stick properly.
Page 25 PRECAUTIONS : Check the Package. Check sensor kit package before opening it. Do not insert the sensor if the sterile package is damaged, broken, or unsealed before you open the package, due to infection risks. Check the Expiry Date. Discard and do NOT use the Sensor Kit after the expiry date (YYYY-MM-DD) printed on the sealing paper.
Page 26 6. Place the inserter over the desired site and push down firmly to insert the sensor. Keep pressing Arrow mark for 10 seconds to ensure the adhesive patch is upward fully attached to your skin. 5. Open the sensor kit cap. NOTE : NOTE : 1.
Page 27 PRECAUTIONS : 1. Apply the sensor immediately after opening its package and the cap. Otherwise, it may present an infection risk. 2. Do not push down the inserter until it is placed over the insertion site. 7. Gently move the inserter away from your 3.
Page 28: Attach Your Transmitter
ATTACH YOUR TRANSMITTER PRECAUTIONS : Bleeding or bruising at the insertion site under or around the sensor base after applying PRECAUTIONS : the sensor is extremely uncommon. If bleeding occurs or you experience high levels of DO NOT Share Your Re-chargeable Transmitter. The transmitter is rechargeable and discomfort, follow these steps to reduce risks: reusable.
Page 29 Attach your transmitter after the sensor is inserted. Align both • Store both the transmitter and its charger in the storage vial provided with your iFree CGMs. 2. Slide transmitter along the edge of sensor notches Before attaching the transmitter, make sure it is fully charged. Do not remove your transmitter base until both notches on the sensor base and until your sensor session is over.
Page 30: Connect Transmitter With Display Device
CONNECT TRANSMITTER WITH DISPLAY DEVICE Click 2. Press down the transmitter until it clicks into the WARNING : Use a Blood Glucose (BG) Meter. During the first 2-hour sensor warm-up period after you sensor base. NOTE : insert a new sensor, use a BG meter to make treatment decisions. You will not receive any Try using a mirror or asking others for assistance sensor readings, alarms or alerts until your system begins to transmit data.
Page 31 Mobile App: 1. Make sure you have followed the steps in the "Apply Your Sensor" and "Attach Your Transmitter" sections. When the screen displays "Apply properly confirm", 2. Your smartphone will automatically search for your press [Confirm and Connect]. transmitter. Keep your smartphone close to you. NOTE : Make sure you go through all steps in the "Pair the Sensor and Transmitter Using NFC"...
Page 32 Receiver: 1. Make sure you follow the steps in the "Apply Your Sensor" and "Attach Your Transmitter". When the receiver displays "Ready to Start", press [Connect]. NOTE : Make sure you go through all steps in the "Pair 3. After the system is connected, the screen will display the Sensor and Transmitter Using NFC"...
Page 33 Mobile App: 3. After the system is connected, the receiver will display a warmup progress. When the warmup is completed, "Warmup" will dissapear from your The monitoring session ends automatically when the display. sensor reaches the ends of its 14-day life and the sensor reading will no longer be shown on the screen.
Page 34: Ending A Monitoring Session
ENDING A MONITORING SESSION END THE MONITORING SESSION PRECAUTIONS : Do Not Reuse. Reuse of a sensor, sensor base or adhesive patch may cause infection or irritation. Ending a Session Early: If any unexpected issues (irritation or discomfort) happen at the application site, consult your healthcare professional for further assistance to prevent serious adverse events.
Page 35 To end a monitoring session before receiving the "Monitoring Ends" notification, open the menu The monitoring session ends automatically when and select "Manually Stop". You will see a message warning you that the sensor has not yet the sensor reaches the end of its 14-day life and expired.
Page 36: Sensor And Transmitter Removal
SENSOR AND TRANSMITTER REMOVAL Do not remove your transmitter until your sensor session is over. Once the session has ended, Pinch follow these steps to remove your sensor and transmitter: one corner 2. Pinch one corner of the unnotched edge to hold the transmitter and the sensor base together.
Page 37 Align notch toward charger 6. Hold the charger face up. Align the notch of 4. Keep the transmitter to use with the next sensor. the transmitter toward the charger’s transmitter Discard the sensor, sensor base and adhesive compartment with the transmitter’s metal patch according to local regulations for disposal components facing down.
Page 38: Understand Your Glucose Readings
UNDERSTAND YOUR GLUCOSE READINGS Your glucose readings appear on the receiver's screen. It is important to understand your readings. HOME SCREEN INDICATOR AND DISPLAYS OVERVIEW Your glucose information (e.g. reading, glucose graph, trend arrow indicating rates and direction of glucose change, etc.) is displayed on your receiver’s screen. It is important to understand these indicators before use.
Page 39: Glucose Trend Arrow And Arrow Color
GLUCOSE TREND ARROW AND ARROW COLOR Direction Glucose is Glucose Glucose rising Glucose Glucose falling There are 5 different trend arrows reflecting your glucose readings and how fast they are changing. steady* rising** rapidly*** falling** rapidly*** The color (orange, amber, green, pink and red) of the arrow helps identify the risk of hypoglycaemia Arrow Color and hyperglycaemia.
Page 40: Add And Access Notes
ADD AND ACCESS NOTES 3. Select the options (carbs, insulin, exercise) and 1. From the Home screen, add a note by tapping follow the prompts to add a note. 4. Tap to save your notes. 2. Make sure the time is correct.
Page 41: High/Low Readings
HIGH/LOW READINGS Mobile App: If HIGH appears on your display device screen, your glucose reading is above 500 mg/dL. Do a blood glucose test with a BG meter. If you also get a HIGH result (> 500 mg/dL) from the meter test, contact your healthcare practitioner immediately.
Page 42: Calibration
Receiver: CALIBRATION The calibration allows alignment between your system readings and your meter values. When the iFree CGMs needs to be calibrated (as shown in the table below), the display device will send a calibration alert. HIGH indicates the sensor reading is above the Required detection limit.
Page 43 When you calibrate, take a fingerstick measurement from your BG meter then enter the value according to the following steps: Mobile App: 2. Enter the exact BG value then press [OK]. 1. From the Calibrate screen, tap [Take fingertip glucose].
Page 44 Receiver: 3. You will see a prompt from the screen. Tap [OK]. 1. From the Calibrate screen, tap [Calibrate]. NOTE : Only a BG value between 40 mg/dL (2.2 mmol/L) and 500 mg/dL (27.8 mmol/L) can be used for calibration. If your BG value is significantly different from your sensor reading, it is recommended to calibrate again to avoid inaccurate readings.
Page 45: Connection And Data Uploading
CONNECTION AND DATA UPLOADING 3. You will see a prompt from the receiver. Tap Mobile App: [Yes]. The mobile App can automatically upload your monitoring results to the cloud via the Internet. NOTE : Refer to the original manual of your smartphone to learn how to set up a mobile network or Wi-Fi to Only a BG value between 40 mg/dL (2.2 mmol/L) connect to the Internet.
Page 46: Treatment Decisions
TREATMENT DECISIONS WARNINGS : Before you start using the iFree CGMs for treatment decisions, make sure you are familiar with the DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not tips provided in this chapter and you have a good understanding of how the system works. match how you are feeling, perform a test with a blood glucose meter.
Page 47: When Not To Use Sensor Readings To Make Treatment Decisions
WHEN NOT TO USE SENSOR READINGS TO MAKE TREATMENT DECISIONS PRECAUTIONS : You must not make treatment decisions based on your sensor glucose reading in the following Sensor Readings may be Different from BG Meter Values. During periods of rapid situations: change in blood glucose (e.g.
Page 48: Trend Arrows And Treatment Decisions
TREND ARROWS AND TREATMENT DECISIONS Treatment Decision Trend arrows show the direction and rate of change of your glucose to give you an idea of where Trend your glucose is going. The following table gives you some ideas on how you may use the arrows Low Glucose Glucose in High Glucose...
Page 49 Treatment Decision Treatment Decision Trend Trend Low Glucose Glucose in High Glucose Glucose in High Glucose Arrow Arrow Glucose (< 70 mg/dL) Target Range (> 250 mg/dL) Target Range (> 250 mg/dL) (< 70 mg/dL) Horizontal (Pink/Red Arrow • If you are about to (Orange Arrow Color) 45°...
Page 50: Specifications
SPECIFICATIONS TRANSMITTER SPECIFICATIONS SENSOR KIT SPECIFICATIONS Transmitter Size 32.8 x 19.8 x 4.15 mm (± 0.5 mm) Sensor Glucose Range 40 - 500 mg/dL Transmitter Weight 3.2g with battery (± 0.5g) Sensor Use Life up to 14 days Power Source Rechargeable lithium battery (3.7V) Shelf Life 12 months...
Page 51: Receiver Specifications
The transmitter and display device connect to each other via BLE network. Connection quality Battery Run Time 7 days (typical use) is in accordance with the Bluetooth Specification v4.2. The iFree CGM System is designed to accept radio frequency (RF) communications from recognized and paired display devices only. Battery Charging Time...
Page 52: Transmitter Charger Specifications
TRANSMITTER CHARGER SPECIFICATIONS Charging Port USB-C Charger Channel Wi-Fi 802.11b/g/n (2.4 GHz) Indicator LED (Green/Amber) IP22 Input Port USB Type Protection against insertion of fingers and objects Weight 10g (± 1.0) Ingress Protection Rating greater than 12.5 millimeters. Protection against dripping Charger Dimensions 37.3 x 26.0 x 22.5 mm (±...
Page 53: Certificate Statement
CERTIFICATE STATEMENT Turning the equipment on and off in proximity to a radio or television will determine whether the FCC STATEMENT equipment is causing interference to signal reception. If interference is present, the user is This device complies with part 15 of the FCC Rules. Operation is subject to the following two encouraged to attempt to resolve it by one or more of the following methods: conditions: •...
Page 54: Appendix
APPENDIX Mobile App: GLUCOSE AND SIGNAL LOSS ALERTS Screen Event Visual & Sound Settings There are delayed or no alarms/alerts in the following situations. When not in the following Hyper Alert Default Setting: situations, alarms/alerts will happen in 5 seconds. Happens when •...
Page 55 Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Hypo Alert Default Setting: Urgent Low Glucose Default Setting: Happens when Happens when • Visual Safety Symbol ( ) on Home • Visual Safety Symbol ( ) on Home glucose is lower than Screen: Yes.
Page 56 Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Transmitter is too Default Setting: Transmitter is not Default Setting: far from the receiver • Visual message on the screen: Yes working. • Visual message on the screen: Yes or when there is an •...
Page 57 Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings The system detects Default Setting: Your sensor session Default Setting: a current error • Visual message on the screen: Yes. has expired. • Visual message on the screen: Yes. measured by the •...
Page 58 Receiver: Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Low Glucose Alert Default Setting: High Glucose Alert Default Setting: Happens when • Visual Safety Symbol ( ) on Home Happens when • Visual Safety Symbol ( ) on Home glucose is lower than Screen: Yes.
Page 59 Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Urgent Low Alarm Default Setting: Transmitter is too Default Setting: Happens when far from the receiver • Visual message on the screen: Yes • Visual Safety Symbol ( ) on Home glucose is at or below Screen: Yes.
Page 60 Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Transmitter is not Default Setting: The system detects Default Setting: working. • Visual message on the screen: Yes a current error • Visual message on the screen: Yes. Alert priority - •...
Page 61: Customer Service
ON/OFF by the user. from defects in materials and workmanship for one year from the date of purchase. This warranty does not apply to the performance of a RIGHTEST product that has been altered, misused, tampered with or abused in any way.
Page 62 Manufacturer’s declaration - Electromagnetic emissions Manufacturer’s declaration - Electromagnetic immunity The Receiver is intended for use in the electromagnetic environment (for home healthcare) The Receiver is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the Receiver should ensure that it is used in such specified below.
Page 63 Electromagnetic Manufacturer’s declaration - Electromagnetic immunity Immunity IEC 60601 Compliance environment - Guidance (for home test test level level The Receiver is intended for use in the electromagnetic environment (for home healthcare) healthcare environment) specified below. Voltage dips: Voltage dips: The customer or the user of the Receiver should assure that it is used in such an environment.
Page 64 Recommended separation distance between Electromagnetic Immunity IEC 60601 Compliance portable and mobile RF communications equipment and the Receiver (HR321), environment - Guidance test test level level Receiver (HR320) (for home healthcare environment) The Receiver is intended for use in an electromagnetic environment (for home healthcare) in Recommended separation distance: which radiated RF disturbances are controlled.
Page 65 Manufacturer’s declaration - Electromagnetic immunity For transmitters rated at a maximum output power not listed above, the recommended Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in equipment (only applicable for CE regulatory) watts (W) according to the transmitter manufacturer.
Page 66 Compliance IMMUNITY Test Band Maximum LEVEL 1800; Service Modulation Distance TEST 1720 frequency power (V/m) CDMA LEVEL (MHz) (MHz) (for home 1900; (V/m) Pulse healthcare) 2400 modulation 1845 – 1900; LTE Band Pulse 2570 DECT; – modulation 217 Hz LTE Band b) 217 Hz 1, 3, 1970...
Page 67 Compliance IMMUNITY NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting Test Band Maximum LEVEL Service Modulation Distance TEST antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test frequency power (V/m)