Rightest HM312, User Manual

Page 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...

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Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...