Aulisa GA-AP0011, Instructions For Use Manual

Page 1: ...Instructions For Use ____________________________________________________________ 7MN00025 01 Guardian Angel Rx Thermometer Module ...

Page 2: ...anual shall imply Taiwan Aulisa Medical Devices Technologies Inc Aulisa is a registered trademark of Taiwan Aulisa Medical Devices Technologies Inc Taiwan Aulisa Medical Devices Technologies Inc No 218 2 Chong Yang Rd Nangang Dist 11573 Taipei City Taiwan Tel 886 809 083 100 Distributed by Aulisa Medical USA Inc 999 Commercial Street Suite 208 Palo Alto CA 94303 USA Tel 1 833 828 5472 www aulisa c...

Page 3: ...n 8 Device Setting Up 9 Device Pairing 11 Automatic Pairing 11 Manual Pairing 11 Device Power Off 12 Device Battery Replacement 12 Normal Body Temperature Ranges 13 Alarm 13 Care and Maintenance 13 Cleaning 13 Troubleshooting 15 Manufacturer s Declaration 16 FCC Compliance 19 Service Support and Warranty 21 Privacy Policy 22 Our Policy 22 Changes 23 Specifications 30 Parts and Accessories 31 ...

Page 4: ...3 Guide to Symbols ...

Page 5: ...4 ...

Page 6: ...essing clinical signs and symptoms 4 Do not use the device on wounded or irritated skin In case of skin discomfort remove the device immediately 5 It is recommended for indoor use only 6 The device is to be worn under the armpit Exposure to ambient temperature may cause inaccurate temperature readings 7 Do not submerge the device in the water or any other liquid 8 Do not use this device while taki...

Page 7: ...rference in a typical medical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare and other environments it is possible that high levels of interference due to close proximity or strength of a source might disrupt the device s performance 15 Follow local governing ordinances and recycling instructions regar...

Page 8: ...composed of Thermometer Box and Sensor Patch It must be used within 32 8 feet 10 meters to the Display Unit for GA1000 Series or to the Receiver Transponder for GA2000 Series Thermometer Box The reusable compact sized battery operated Thermometer Box is embedded with a Bluetooth module The battery is changeable ...

Page 9: ...dditional Sensor Patch can be purchased separately as needed Device Intended Use The Thermometer Module is indicated for continuous armpit body temperature monitoring for adult pediatric and infant patients The intended environments of use are hospitals medical facilities home care and subacute environments Device Principle of Operation The Thermometer Module applies the digital temperature sensor...

Page 10: ...ector of the Thermometer Box aligns with the connector on the holder Step 2 Secure the Thermometer Box onto the holder of the Sensor Patch Step 3 Peel the releasing paper off the Sensor Patch Step 4 Attach the sensor probe to the center of the armpit with the Thermometer Box placed on the chest NOTE The Power LED will blink green when the power is ON ...

Page 11: ... established Once connected the vital signs and the Thermometer Module status information will appear on the MAIN screen NOTE Refer to the GA1000 Series Instructions for Use 7MN00021 01 or GA2000 Series Instructions for Use 7MN00022 01 for setting up instructions and verifying system operation NOTE The Thermometer Module only measures axillary armpit temperature NOTE Refer to Device Pairing sectio...

Page 12: ... In the Setting menu select PAIRING for GA1000 Series In the Setting menu select PAIRING SENSOR MODULE for GA2000 Series Step 3 Scan the QR Code or key in the serial number located on the back of the Thermometer Box Step 4 Check if the serial number SN displayed matches with the one on the Thermometer Box Step 5 Press CONFIRM on the Display Unit Step 6 Assemble the Thermometer Box and the Sensor P...

Page 13: ...e the battery Step 1 Take off the battery cover by using a coin turning the cover clockwise and remove the battery Step 2 Insert a new CR2025 battery into the battery chamber and replace the cover Align the mark on the cover with the lock icon NOTE Make sure the battery is installed before use NOTE The Thermometer Module remains paired with the system until the serial number is deleted from the li...

Page 14: ...formation about the alarm refer to the GA1000 Series Instructions for Use 7MN00021 01 or GA2000 Series Instructions for Use 7MN00022 01 Care and Maintenance The advanced digital circuitry within the Thermometer Module requires no calibration or periodic maintenance Field service or repair of this system is not possible Do not attempt to open the case other than the battery cover for that will caus...

Page 15: ...t pour or spray any liquids onto this device and do not allow any liquids to enter any openings in the device CAUTION Do not immerse the device in liquid and do not use caustic or abrasive cleaning agents on the device ...

Page 16: ...Make sure the Infant Thermometer Module is within 32 8 feet 10 meters spherical radius to the Display Unit for GA1000 Series or to the Receiver Transponder for GA2000 Series 2 Power off the system and retry For additional troubleshooting refer to the GA1000 Series Instructions for Use 7MN00021 01 or GA2000 Series Instructions for Use 7MN00022 01 If these solutions do not correct the problem please...

Page 17: ...s Declaration Refer to the following table for specific information regarding compliance to IEC 60601 1 2 for this device Guidance and manufacturer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS ...

Page 18: ...17 Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS ...

Page 19: ...18 Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING ...

Page 20: ...enna 2 Increase the separation between the equipment and receiver 3 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected 4 Consult the dealer or an experienced radio TV technician for help The device is designed and manufactured not to exceed the emission limits for exposure to radio frequency RF energy set by the Federal Communications Commissio...

Page 21: ... modifications to this device that are not expressly approved by Taiwan Aulisa Medical Devices Technologies Inc may void the user s authority to operate the equipment CAUTION No modifications to this device are allowed that in any way affect or alter its antenna or antenna configuration ...

Page 22: ...d ii purchaser has returned the product to Aulisa in accordance with instructions provided on Aulisa s support webpage and iii Aulisa has verified that the product is defective Aulisa warrants a replacement or repaired product only for products purchased from authorized resellers and only for the unexpired term of the Warranty Period for the defective product A return merchandise authorization RMA...

Page 23: ...MATION WE COLLECT AND TRANSMIT MAY INCLUDE HEALTHCARE INFORMATION INCLUDING MEDICAL INFORMATION THEREFORE OUR PRIVACY PRACTICES ARE INTENDED TO COMPLY WITH THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT HIPAA WE WILL MAINTAIN THE PRIVACY OF YOUR HEALTH INFORMATION AS REQUIRED BY HIPAA AND THE REGULATIONS PROMULGATED UNDER THAT ACT FOR ADDITIONAL INFORMATION RELATED TO YOUR HEALTHCARE INFO...

Page 24: ...the Customer Agreement Aulisa may collect use and disclose information from a Customer and such Customer s authorized users as set forth in the Customer Agreement If you would like more information about the Devices or becoming a Customer please contact us at information aulisa com Changes PLEASE NOTE THAT WE OCCASIONALLY UPDATE THIS PRIVACY POLICY AND THAT IT IS YOUR RESPONSIBILITY TO STAY UP TO ...

Page 25: ...e an active participant with those providers in monitoring your care tailoring interventions and assessing treatment outcomes We may also use your Personal Information to 1 store data 2 comply with the law 3 respond to requests from public and government authorities 4 to enforce our terms and conditions 5 manage and improve our operations and applications 6 provide additional functionality 7 prote...

Page 26: ...tored on secure third party cloud based servers or through a Wi Fi network All of the information you share with us through the Devices is double encrypted during transmission using AES 128 data encryption as well as an Aulisa private encryption method Will You Share My Personal Information With Anyone Else We consider your information to be a vital part of our relationship with you There are howe...

Page 27: ...his five year period we will remove your Personal Information from our databases and will request that our business partners remove your Personal Information from their databases However once we disclose your Personal Information to third parties we may not be able to access that Personal Information any longer and cannot force the deletion or modification of any such information by the parties to...

Page 28: ...e such notices in writing NOTWITHSTANDING ANY OF THE STEPS WE TAKE IT IS NOT POSSIBLE TO GUARANTEE THE SECURITY OR INTEGRITY OF DATA TRANSMITTED OVER THE INTERNET THERE IS NO GUARANTEE THAT YOUR INFORMATION WILL NOT BE ACCESSED DISCLOSED ALTERED OR DESTROYED BY BREACH OF ANY OF OUR PHYSICAL TECHNICAL OR ADMINISTRATIVE SAFEGUARDS THEREFORE WE DO NOT AND CANNOT ENSURE OR WARRANT THE SECURITY OR INTE...

Page 29: ...able format to lodge a complaint with a supervisory authority Where our processing of your Personal Information is based on consent you have the right to withdraw that consent without detriment at any time by contacting us at information aulisa com You can also exercise the rights listed above at any time by contacting us at information aulisa com How Can I Update Correct Or Delete My Personal Inf...

Page 30: ...29 How Can I Contact Aulisa If you have any questions or comments about this Privacy Policy our practices or our Devices please feel free to e mail us at information aulisa com ...

Page 31: ... 107 6 F 0 2 F 32 C 42 C 0 1 C Battery Type CR2025 Battery Life 7 days Temperature Operating 5 C to 40 C Storage Transportation 25 C to 70 C Humidity Operating 15 to 90 R H non condensing Storage Transportation 10 to 93 R H non condensing Operating Altitude altitude 3 000 m Atmospheric Pressure 700 hPa to 1013 hPa Wireless Communication Range 32 8 feet 10 meters spherical radius Protocol Bluetooth...

Page 32: ...s Instructions for Use 7MN00021 01 or GA2000 Series Instructions for Use 7MN00022 01 You may also contact your distributor or contact Aulisa by going online at www aulisa com under Contact Us 7MN00025 01 CAUTION Using accessories not by Taiwan Aulisa Medical Devices Technologies Inc may result in inaccurate measurements Always use parts and accessories by Taiwan Aulisa Medical Devices Technologies...