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Digital Vital Sign Monitoring System

Instructions For Use

____________________________________________________________

7MN00026-02

Guardian Angel

Lite

GA1000 Series

Содержание Guardian Angel GA1000 Series

Страница 1: ...Digital Vital Sign Monitoring System Instructions For Use ____________________________________________________________ 7MN00026 02 Guardian Angel Guardian Angel Lite GA1000 Series...

Страница 2: ...hall 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 Cho...

Страница 3: ...with a new Aulisa sensor module 18 Device Verification 19 Verify the device function 19 Verify the alarm function BEFORE each use 19 Display Unit Power Off 20 Display Unit Powering 20 Alarms and Limit...

Страница 4: ...3 Guide to Symbols Single Use...

Страница 5: ...4 Date of Manufacture...

Страница 6: ...le application can be installed on your mobile device as the display of the system to replace the Display Unit Please download Aulisa Lite GA1000 from App Store or Google Play Adult Pediatric Oximeter...

Страница 7: ...1000 Series Function The Aulisa sensor module s detects vital signs and sends out the data to the Display Unit or Aulisa mobile application for display using Bluetooth technology The system also provi...

Страница 8: ...wallowed such as port covers They are hazardous to children 5 Do not use in or around water or any other liquid when AC power adaptor is used 6 Only use this device with charging adaptors provided by...

Страница 9: ...8 Device Components Display Unit Aulisa mobile application Aulisa Lite GA1000 Smartphone not included Display Unit Stand Display Unit Charging Adapter Type C...

Страница 10: ...isplay Unit when installed on personal mobile devices Please download Aulisa Lite GA1000 from App Store or Google Play Below table introduces the interface of the Aulisa mobile application Icon Descri...

Страница 11: ...faults of alarm setting Setting Item Description Module Pairing Enter a serial number of Aulisa sensor module s either by scanning the QR code or by key in the number manually Alarm Setting Adjust the...

Страница 12: ...terface of the Display Unit Icon Name Description SpO2 Blood oxygen Blood oxygen saturation PR bpm Pulse rate Pulse rate beats per minute TEMP Body temperature Body temperature in either C or F Pulse...

Страница 13: ...ndicates whether the Infant Oximeter Module is attached to the foot A system alarm will be displayed if no contact is detected between the sensor and the foot Motion indicator This animated icon detec...

Страница 14: ...t gender date of birth and location Establish system connection This button appears when the Aulisa sensor module s is not connected to the Display Unit Press the button to build a system connection N...

Страница 15: ...or module s to manually pair with the display unit Pause alarm audio This button appears when an alarm is triggered Tap on the button to temporarily silence the alarm audio of the current triggered al...

Страница 16: ...15 the button to clear the alarm of bluetooth disconnected or power off...

Страница 17: ...ns to complete the system setup Step 3 Connect the charging adaptor to the Display Unit and a power outlet Step 4 Press and hold the Power button for at least three 3 seconds to turn on the Display Un...

Страница 18: ...e Aulisa sensor module s must be used within 32 8 feet 10 meters to the Display Unit mobile device NOTE The Bluetooth connection status icon will turn blue once the pairing succeeds NOTE Verify System...

Страница 19: ...le s Step 4 Power on the designated Aulisa sensor module s Step 5 To confirm that the process was successful ensure that the Bluetooth connection status icon on the MAIN screen is lit blue NOTE The Au...

Страница 20: ...t up the system Refer to the Aulisa sensor module s Instructions for Use for setting up instructions Step 2 Ensure the Bluetooth connection is established See Device Pairing section Step 3 Set the ala...

Страница 21: ...ng adaptor accidentally proceed with the following steps to charge and power the Display Unit The Display Unit will alert the user when the Display Unit itself is low on battery Step 1 Plug the Type C...

Страница 22: ...onitored including SpO2 pulse rate and temperature alarms On the screen high priority alarms are indicated with rapid blinking vital sign readings in red color and with alarm text message when alarm l...

Страница 23: ...on to permanently silence the alarm audio See Alarm Limits section to learn adjusting the alarm limit Medium Priority Alarms Medium priority alarms are those that signal potential problems with the eq...

Страница 24: ...ot 1 Alarm text message in yellow blinks rapidly on the Display Unit or shown as pop up notification on Aulisa mobile application 2 Alarm LED indicator on the Oximeter Module Infant Oximeter Module bl...

Страница 25: ...Aulisa mobile application CAUTION Silencing alarms does not mean the situation has been resolved CAUTION Tapping on AUDIO OFF button will permanently silence the alarm audio of the current triggering...

Страница 26: ...low to review or set alarm limits Step 1 Ensure the Bluetooth connection is established See Device Pairing section Step 2 Tap on SETTING button on the MAIN screen and then tap on ALARM SETTING button...

Страница 27: ...g the seekbar to adjust the values OR tap on RESTORE DEFAULTS to restore alarm limits to manufacturer configured values NOTE Alarm limits can be adjusted only when the Aulisa sensor module s is paired...

Страница 28: ...before adjusting the alarm limits CAUTION A potential hazard exists if different alarm presets are used for the same or similar equipment in any single area CAUTION When turned off the alarms will no...

Страница 29: ...ls High Priority Alarm Factory Default Adjustment Options Adjustment Interval SpO2 Upper Alarm Limit Off Off 85 100 1 SpO2 Lower Alarm Limit 85 Off 50 95 1 Pulse Rate Upper Alarm Limit Adult Pediatric...

Страница 30: ...er an alarm Likewise when the pulse rate fluctuates near an alarm limit each breach will trigger an alarm With the pulse rate alarm delay feature this system allows a period of threshold violation of...

Страница 31: ...is system is not possible Do not attempt to open the case Opening the Display Unit will cause damage and void the warranty If the Display Unit is not functioning properly see Troubleshooting section f...

Страница 32: ...o 2 minutes and alarm tones will automatically re engage 2 Make sure no headphone is plugged in the Display Unit Cannot establish system connection 1 Make sure the Aulisa sensor module s is within 32...

Страница 33: ...ment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 This device uses RF energy only for its internal function Therefore its RF emissions are very low and...

Страница 34: ...hat of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV Line to Line 1 kV Line to Line Mains power quality should be that of a typical commercial or hospital environment Voltage d...

Страница 35: ...y an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF I...

Страница 36: ...35 abnormal performance is observed additional measures may be necessary such as reorienting or relocating thedevice b Over the frequency range 150 kHz to 80 MHz fieldstrengths should be less than 3 V...

Страница 37: ...1 Reorient or relocate the receiving antenna 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...

Страница 38: ...uires this product to be used indoors for the frequency range of 5 15 to 5 25GHz to reduce the potential for harmful interference to co channel mobile satellite systems High power radar is allocated a...

Страница 39: ...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 replac...

Страница 40: ...ATION 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 ACCOUNTA...

Страница 41: ...he 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 abo...

Страница 42: ...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...

Страница 43: ...ored 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 encryp...

Страница 44: ...is 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 disclo...

Страница 45: ...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 INFORM...

Страница 46: ...ble 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...

Страница 47: ...46 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...

Страница 48: ...ing 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 Pr...

Страница 49: ...le s Instructions for Use for more Aulisa sensor module s information You may also contact your distributor or contact Aulisa by going online at www aulisa com under Contact Us 7MN00026 02 CAUTION Usi...

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