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101-3HM312-010 EN

User Manual

Rev

. Da

te: 2021-01

Continuous Glucose

Monitoring System

(HM312)

BIONIME CORPORATION

No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
E-mail: [email protected]
http://www.bionime.com

Use with a receiver (HR310)

Emergo Europe

Prinsessegracht 20
2514 AP The Hague
The Netherlands
Email: [email protected]

Содержание HM312

Страница 1: ...BIONIME CORPORATION No 100 Sec 2 Daqing St South Dist Taichung City 40242 Taiwan Tel 886 4 2369 2388 Fax 886 4 2261 7586 E mail info bionime com http www bionime com Use with a receiver HR310 Emergo...

Страница 2: ......

Страница 3: ...important that you read this entire manual before using the system for the first time I INDICATIONS FOR USE STATEMENT AND ADVISORY INDICATIONS FOR USE STATEMENT AND ADVISORY II SAFETY INFORMATION III...

Страница 4: ...TOMER INFORMATION CUSTOMER SERVICE WARRANTY 5 CONTENTS 4 COTENTS VI SET UP YOUR RIGHTEST CGMS PAIRING THE SENSOR AND TRANSMITTER USING NFC APPLY YOUR SENSOR ATTACH YOUR TRANSMITTER CONNECT TRANSMITTER...

Страница 5: ...nstruct all personnel responsible for the proper use and care of the RIGHTEST CGMs All users are urged to carefully read this manual before using the system II SAFETY INFORMATION The following is a su...

Страница 6: ...e dangerous if swallowed INTERNALLY POWERED ME EQUIPMENT Not Suitable for use in an OXYGEN RICH ENVIRONMENT WARNINGS Read This Manual First Failure to operate the system according to the guidelines an...

Страница 7: ...your sensor remove the sensor and stop using the RIGHTEST CGMs If needed consult your health care professional 11 Safety Information 10 Safety Information Avoid Skin Care Products or Insect Repellent...

Страница 8: ...tal glass or water in between Obstructions or longer distances may cause Bluetooth signal loss and you will not receive important alerts alarms Plug in to Charge Be sure to fully charge your transmitt...

Страница 9: ...all wires greater than 1 millimeter Protected from immersion between 15 centimeters and 1 meter in depth 15 Symbol Definitions SYMBOL DEFINITION SYMBOL DEFINITION Protected against insertion of finger...

Страница 10: ...or 2 TRANSMITTER Rechargeable for multiple use for a single patient 3 RECEIVER Blood glucose information display 4 POWER SUPPLY AC power adapter USB cable 5 TRANSMITTER CHARGER A USB charging dock for...

Страница 11: ...ust one hand Easy to read visual glucose values and trends Transmitter s powerful storage holds 14 days of glucose readings with zero data loss Getting visual and audible alerts to hypoglycemia and hy...

Страница 12: ...s your glucose information TRANSMITTER The transmitter sends your glucose data from the sensor to the Receiver The transmitter is equipped with a rechargeable battery RECEIVER The receiver displays gl...

Страница 13: ...ours when using the supplied USB adapter plugged into a standard household electrical outlet 100 to 240V AC 50 60 Hz It is recommended to use only the supplied USB cable and USB power adapter CHARGING...

Страница 14: ...nput of the receiver 1 25 Before Getting Started 2 Connect the USB plug to the USB port of the AC power adapter supplied with your system and connect the adapter to the power source Alternatively conn...

Страница 15: ...There are no alarm alerts when your transmitter battery is dead PRECAUTIONS Use only the AC power adapter USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver and tra...

Страница 16: ...ing up With the transmitter outer frame between your fingers steadily slide the transmitter all the way into the compartment 1 2 Storage Vial Transmitter Charger Alignment Notch 3 With the transmitter...

Страница 17: ...fully charged unplug the transmitter charger from the power source 7 If you wish to take out the transmitter from its charger or to store the transmitter charger turn over the charger to the back side...

Страница 18: ...System Each sensor has its unique code established on the tag attached on the sensor inserter package The transmitter s code is located right beneath its top plastic cover where you see a mark Every...

Страница 19: ...EST CGMs 34 Set Up Your RIGHTEST CGMs 3 Tap Home at the bottom of your receiver screen Then tap New Monitor to start a new monitoring session 3 4 When the receiver prompts you to pair the sensor trans...

Страница 20: ...of NFC panel is engraved with a mark 5 NFC panel 6 Tap the receiver s NFC panel against the tag on top of the sensor inserter package until you hear a beep sound NOTE Be sure your receiver s NFC pane...

Страница 21: ...confirmation is displayed as by checkmark on the receiver screen 7 8 Tap receiver s NFC panel against the NFC mark on the top of transmitter until you hear a beep sound NOTE Be sure your receiver s N...

Страница 22: ...eiver displays Pairing Complete press Next 11 You will be prompted to enter your personal security code Then press Done 12 Make sure you follow the step by step instructions in the installation guide...

Страница 23: ...eas with scars tattoos or moles Select a skin area that stays flat during normal daily activities Choose a site that is greater than 1 inch 2 5 cm away from any insulin injection sites Change the Sens...

Страница 24: ...ure the adhesive patch is fully attached to your skin NOTE Use a different site for the next sensor insertion NOTE Do not apply the inserter if the base falls out when opening the cap Use a new one Do...

Страница 25: ...alarms alerts etc may be wrong Use Charger as Directed Use only the AC power adapter USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver and transmitter Using differ...

Страница 26: ...nsmitter 1 Get your transmitter 2 If necessary clean the transmitter with an alcohol wipe While you do so do not touch or scratch its metal components located at the bottom NOTE Be sure your transmitt...

Страница 27: ...e your receiver is close to your transmitter and in the same room The maximum transmission distance is 6 meters 20 feet with no obstructions e g wall metal glass or water in between Obstructions or lo...

Страница 28: ...er using NFC section again If the problem persists refer to the troubleshooting section 53 Set Up Your RIGHTEST CGMs 2 The receiver will automatically start searching for your sensor transmitter pair...

Страница 29: ...n 54 Ending a Monitoring Session VII ENDING A MONITORING SESSION You will receive a 24 Hours Before the End of Sensor Session alert on your receiver 24 hours prior to monitoring ending Press OK to con...

Страница 30: ...for the sensor to fully expire You will receive a Sensor Expired alert and the session will end automatically Press Done confirm you read this alert End the monitoring session early by selecting the u...

Страница 31: ...a point two thirds along the length of the base and across from the notch Then pinch firmly at this point with your thumb and index fingers While you do so grip a corner of the notched edge of the se...

Страница 32: ...r receiver s Home screen It is important to understand these indicators before use An overview of the home screen is shown below 61 Understand Your Glucose Readings Overview of Receiver Home Screen Cu...

Страница 33: ...t or more than 2 mg dL per minute There is no glucose value or trend arrow HIGH LOW event During the first 2 hour sensor warmup period The sensor glucose concentration reading range is 40 500 mg dL A...

Страница 34: ...our Glucose Readings glucose is steady means the glucose rate of change is in between 0 to 1 mg dL glucose falling rising means the glucose rate of change is in 1 2 mg dL per minute glucose falling ri...

Страница 35: ...rcle at the right end of the plot The sensor glucose reading range is 40 500 mg dL The trend graph uses a dynamic range of 0 500 mg dL The default graph displays a range of 0 250 mg dL and is able to...

Страница 36: ...a note by tapping the symbol in the lower right corner of the screen 1 2 69 Understand Your Glucose Readings 2 Make sure the time is correct 3 Select the options carbs insulin exercise then follow the...

Страница 37: ...information or to view your personal notes from anytime between the first and most recent reading hold and drag the trend graph left or right Note entries will be displayed on the upper portion of th...

Страница 38: ...so get a HIGH result 500 mg dL from the meter test contact your healthcare practitioner immediately If LOW appears on your receiver screen your glucose reading is less than 40 mg dL Do a fingerstick b...

Страница 39: ...to identify your glucose patterns The 7 days 14 days 30 days and 90 days result of AGP analysis can be reviewed on the Report page From the Report screen choose the duration of your glucose summary s...

Страница 40: ...til your system begins to transmit data If you suspect that your sensor readings may be inaccurate for any reason If your sensor readings do not match what you are feeling If you are experiencing symp...

Страница 41: ...se the entries then enter the correct value NOTE Make sure you enter the exact value that is measured with 5 minutes 2 79 Calibration Optional 3 You will see a prompt from receiver Tap Yes or No 4 The...

Страница 42: ...althcare practitioner Use a Blood Glucose BG Meter To Make Treatment Decisions Under The Following Conditions During the first 2 hour warmup period when you start a new sensor You won t get any sensor...

Страница 43: ...is symbol on your screen do a fingerstick blood glucose test and make treatment decisions based on that result Glucose is Falling Rising Rapidly with upwards downward pointing arrow Glucose measured i...

Страница 44: ...Treatment Decisions Trend Arrow Treatment Decision Low Glucose 70 mg dL Glucose in Target Range High Glucose 250 mg dL 45 upward arrow Rouge Red Arrow Colors You will see symbol Do a fingerstick blood...

Страница 45: ...sider adjusting insulin correction dose upwards Avoid Insulin stacking 87 Treatment Decisions Trend Arrow Trend Arrow Low Glucose 70 mg dL Glucose in Target Range High Glucose 250 mg dL 45 downward ar...

Страница 46: ...C 45 C 41 F 113 F Relative humidity 10 90 Sensor Ingress Protection Rating when installed with a transmitter Inserter Storage Transportation Conditions IP47 Protected from tools and small wires great...

Страница 47: ...ther via BLE network Quality of the connection is in accordance with the Bluetooth Specification v4 0 The RIGHTEST CGM System is designed to accept radio frequency RF communications from recognized an...

Страница 48: ...ICATIONS Dimension 126 1 x 68 1 x 15 2 mm with battery and silicone case 1 0 mm Power Source Rechargeable lithium battery 3 7V 1150mAh Weight 145 g with battery and silicone case 8 Touch Screen Size 4...

Страница 49: ...Rating 37 3 x 26 0 x 22 5 mm 0 5 mm DC 5V 18 20 mA DC 4 2V 18 20 mA Temperature 5 C 45 C 41 F 113 F Relative humidity 10 90 Temperature 5 C 45 C 41 F 113 F Relative humidity 10 90 Caution When operati...

Страница 50: ...ng methods Reorient or reposition the receiving antenna Increase the separation between the equipment and the receiving device Connect the equipment to a different power outlet than the receiving devi...

Страница 51: ...99 98 Certificate Statement NCC STATEMENT...

Страница 52: ...very 30 minutes or until glucose level returns to the target range Editable Setting Sound Vibration can be turned ON OFF by the user 101 Appendix Screen Event Visual Sound Settings Very High Alert hap...

Страница 53: ...ntil glucose level returns to the target range Editable Setting Sound Vibration can be turned ON OFF by the user Screen Event Visual Sound Settings Low Glucose Alert happens when glucose is between 55...

Страница 54: ...el returns to the target range Editable Setting Sound Vibration CANNOT be turned ON OFF by the user 105 Appendix Screen Event Visual Sound Settings Urgent Low Alarm happens when glucose is 54 mg dL De...

Страница 55: ...e and beeps 1 time at highest alarm volume Separated by 1s Displayed continuously for 5 minutes or until OK is pressed System attempts to reconnect every 5 minutes even if user doesn t press OK System...

Страница 56: ...ins System alerts will repeat every 30 minutes Editable Setting Sound Vibration can be turned ON OFF by the user 109 Appendix Screen Event Visual Sound Settings Transmitter battery less than 10 Defaul...

Страница 57: ...sual message on the screen Yes Sound Vibration Alert No 111 Appendix Screen Event Visual Sound Settings 1 Transmitter is too far from the receiver or there is an obstacle e g water wall in between tra...

Страница 58: ...splayed continuously for 5 minutes or until OK is pressed System alerts will repeat every 30 minutes Editable Setting Sound Vibration can be turned ON OFF by the user Screen Event Visual Sound Setting...

Страница 59: ...on Alert Yes Vibrates 1 time and beeps 1 time at the alarm volume following the user settings Separated by 1s Displayed continuously for 5 minutes or until OK is pressed System alerts will repeat ever...

Страница 60: ...minutes or until OK is pressed Editable Setting Sound Vibration can be turned ON OFF by the user Screen Event Visual Sound Settings When the Receiver software detects a sensor that has been used Defau...

Страница 61: ...to report your incident to us and the local competent authority WARRANTY The manufacturer warrants that your RIGHTEST Receiver rechargeable Transmitter will be free from defects in materials and workm...

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