Aulisa Guardian Angel GA2000 Series Instructions For Use Manual

Aulisa Guardian Angel GA2000 Series Instructions For Use Manual

Digital vital sign monitoring system
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Digital Vital Sign Monitoring System
Instructions For Use
____________________________________________________________
7MN00027-01
Guardian Angel
GA2000 Series
®

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Summary of Contents for Aulisa Guardian Angel GA2000 Series

  • Page 1 Guardian Angel ® GA2000 Series Digital Vital Sign Monitoring System Instructions For Use ____________________________________________________________ 7MN00027-01...
  • Page 2: Disclaimer

    Technologies, Inc. reserves the right to make changes and improvements to this manual and the products described within at any time, without notice or obligation. References to “Aulisa” in this manual shall imply Taiwan Aulisa Medical Devices Technologies, Inc. Aulisa is a registered trademark of Taiwan Aulisa Medical Devices Technologies, Inc.
  • Page 3: Table Of Contents

    Wi-Fi Network Initial Setup .................. 21 Wi-Fi Network Reset .................... 22 Device Pairing ....................... 23 Automatic Pairing ....................23 Pairing with a new Aulisa sensor module ............23 Pairing with a new Receiver/Transponder ............24 Device Verification ....................... 26 Verify the device function ..................26 Verify the alarm function BEFORE each use ............
  • Page 4 Service, Support, and Warranty ................... 42 Privacy Policy ........................ 43 Our Policy ......................43 Changes ........................ 44 Specifications ....................... 51 Parts and Accessories ....................53...
  • Page 5: Guide To Symbols

    Guide to Symbols...
  • Page 7: Welcome

    Welcome This manual will help you get started with monitoring using Aulisa Guardian Angel ® GA2000 Series Digital Vital Sign Monitoring System (“GA2000S”) by introducing the Display Unit and the Receiver/Transponder which are intended for use in conjunction with a variety of wearable Aulisa sensor module(s).
  • Page 8: Ga2000S Function

    Transponder Aulisa sensor module(s) Display Unit The Aulisa sensor module(s) is a wearable device intended for vital signs detection and physiological data transmission to the Receiver/Transponder via Bluetooth technology. The Receiver/Transponder communicates with the Display Unit through a customer Wi-Fi network implemented and managed by end users. The Display Unit receives and displays physiological data as well as generates alarms for technical errors or physiological events.
  • Page 9: Precautions For Use

    Do not use in or around water or any other liquid when AC power adaptor is used. Only use this device with charging adaptors provided by Aulisa. Do not immerse any part of the device in any liquids. Do not subject the device to extreme hot or cold temperatures, humidity, or direct sunlight.
  • Page 10: Device Components

    Device Components Display Unit Receiver/Transponder with Aulisa application software Display Unit Stand Display Unit Charging Adapter (Type-C) Receiver/Transponder Receiver/Transponder Clamp Charging Adapter (micro-USB) Receiver/Transponder Sticker Receiver/Transponder Velcro Strap...
  • Page 11: Device Overview

    Device Overview Display Unit The Display Unit features a 10.1” LCD multi-touch display with Wi-Fi connectivity capability. The Display Unit displays real-time vital signs measured by Aulisa sensor module(s). The Display Unit will display informational text messages, alarm text messages, and beep made audible upon an alarm condition trigger event.
  • Page 12 Display Unit No data shows dashes “- - -” in each of the vital sign windows. This icon displays whether the Aulisa sensor module(s) and the Bluetooth Receiver/Transponder are Connection Status connected via Bluetooth. It will turn blue once the pairing succeeds.
  • Page 13 Display Unit when the Display Unit battery level is low. These icons signify the battery level of Aulisa sensor module(s) Battery Level of at Full, Medium, or Low. Aulisa sensor A medium priority system alarm...
  • Page 14 successful connection and red when losing connection. This icon indicates whether Wi-Fi Strength there is a strong connection Indicator between the Display Unit and customer Wi-Fi Network. This icon identifies an alarm condition exists. Alarm Indicator “!!!” represents high priority. “!!”...
  • Page 15 Brightness the display. In the Setting menu, tap on this button to adjust the alarm limits for each Aulisa sensor module. Set Alarm Limits NOTE: The alarm limits are adjustable only when the wireless connection is established.
  • Page 16 In the Setting menu, tap on this button to pair to a new Aulisa sensor module or Receiver/Transponder either by Establish Pairing scanning the barcode or manually keying in the code found on the back of the said device. This button appears when an alarm is triggered.
  • Page 17: Receiver/Transponder

    Bluetooth, integrates audio and video of the person being monitored, and then converts the data to Wi-Fi signals, which are transmitted to and displayed by the Display Unit. The Aulisa sensor module(s) must be used within 32.8 feet (10 meters) to the Receiver/Transponder.
  • Page 18: Audio/Video Feature

    Audio/Video Feature     Video: View monitoring video  Listening: Tap to turn on and receive monitoring audio  Talking: Press and hold to send an audio message When personal privacy is desired, place the sticker over the camera and NOTE: microphone of Receiver/Transponder.
  • Page 19: Device Setting Up

    Device Setting Up Before you begin your monitoring session, unpack the Display Unit and Receiver/Transponder and become familiar with their parts. Step 1: Connect the charging adaptor (micro-USB end) to the Receiver/Transponder and a power outlet. Step 2: You may simply place the Receiver/Transponder on a table or follow the instructions below to assemble the holder and the clamp so that the Receiver/Transponder can be clamped onto the furniture or hung on the wall.
  • Page 20 Hang on the wall Slide the Clamp into the Holder. Hang the Holder on the wall. Ensure the Holder is secure. Place the Receiver/Transponder body on the Holder. Secure the power cable to the Holder with Velcro strap. NOTE: Securing the power cable to the holder with the Velcro strap prevents the Receiver/Transponder body from dropping to the ground.
  • Page 21 MAIN screen. NOTE: Refer to “Device Pairing” sections below for more information. NOTE: The Aulisa sensor module(s) must be used within 32.8 feet (10 meters) to the Receiver/Transponder. NOTE: The Bluetooth connection status icon will turn blue once the pairing succeeds.
  • Page 22: Device Connection

    Device Connection Wi-Fi Network Initial Setup Step 1: Powering the Display Unit and the Receiver/Transponder. Step 2: Turn on the Receiver/Transponder. Wait until the Wi-Fi Link LED on the Receiver/Transponder blinks red. Step 3: Press and hold the Power button of Receiver/Transponder for ten (10) seconds until “RESET”...
  • Page 23: Wi-Fi Network Reset

    Wi-Fi Network Reset For Display Unit Step 1: Tap on “SETTING” → “CONNECTION” → “DISPLAY UNIT”. Step 2: Select the desired Wi-Fi network from the list of available connections displayed on the MAIN screen. Enter the network security password and press “CONFIRM”.
  • Page 24: Device Pairing

    The power LED on the Aulisa sensor module(s) lights green when the power is Step 2: In the Setting menu, select “PAIRING" → “SENSOR MODULE”. Step 3: Scan the QR Code or key in the serial number located on the Aulisa sensor module(s).
  • Page 25: Pairing With A New Receiver/Transponder

    NOTE: The Aulisa sensor module(s) remains paired with the system until the serial number is deleted from the list. Pairing with a new Receiver/Transponder Follow the below instructions to manually set up the pairing of a new Receiver/Transponder. NOTE: Only one (1) Receiver/Transponder can be stored on the Display Unit at a time.
  • Page 26 Create a password for the Receiver/Transponder and press “CONFIRM”. NOTE: The password must contain a combination of numbers and letters with maximum 16 characters. Select the correct time zone and press “CONFIRM”.
  • Page 27: Device Verification

    Step 1: Set up the system. Refer to the Aulisa sensor module(s) Instructions for Use for setting up instructions. Step 2: Make sure Aulisa sensor module(s) is worn on or attached to the right place firmly. Step 3: Verify that the Bluetooth connection status icon on the Display Unit is blue and the status indicator on Aulisa sensor module(s) is blinking green.
  • Page 28: Device Power Off

    Device Power Off Display Unit Step 1: Press the Power button for at least three (3) seconds until a message displayed. Step 2: Choose “Power off” to turn off the Display Unit. NOTE: You may also tap on the “SLEEP” button to enter the sleep mode. Receiver/Transponder Press and hold the Power button for at least three (3) seconds to turn off the Receiver/Transponder.
  • Page 29: Receiver/Transponder

    NOTE: The charging LED indicator lights blue during charging and goes off when fully charged. NOTE: The battery low LED indicator lights yellow when low battery. CAUTION!!! Only use adaptors supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.
  • Page 30: Alarms And Limits

    Alarms and Limits Alarm Features The Display Unit provides high and medium priority audible and visual alarms. The visual alarm is indicated by the alarm window on the screen of the Display Unit. Audio alarms will sound from the speakers on the Display Unit. NOTE: The volume for audio alarms cannot be adjusted.
  • Page 31 High priority audio alarms are: 3 beeps, short pause, 2 beeps, short pause, 3 beeps, short pause, 2 beeps, and 5-second pause. This sequence repeats until the alarm is cleared or silenced. Tap on ʻʻPAUSE AUDIOʼʼ button to pause the alarm audio for 2 minutes. Tap on ʻʻAUDIO OFFʼʼ...
  • Page 32 Thermometer Battery Low Oximeter Module Data Update Period Exceeds Limit (More Than Half A Minute) Aulisa sensor module(s) BLE Disconnected Receiver/Transponder Wi-Fi Disconnected Medium priority audio alarms are: 3 beeps and 25-second pause. This sequence repeats until the alarm is cleared or silenced.
  • Page 33 Multiple Alarms When there are high and medium priority alarms triggered simultaneously, the system will display all the alarm text messages but will only sound the high priority alarm. CAUTION!!! Silencing alarms does not mean the situation has been resolved. CAUTION!!! Tapping on “AUDIO OFF”...
  • Page 34: Alarm Limits

    Follow the instructions below to review or set alarm limits. Step 1: Ensure the system connection (Bluetooth/Wi-Fi) is established. (See “Device Connection” and “Device Pairing” sections.) Step 2: Tap on "SETTING" button on the MAIN screen, and then tap on “ALARM LIMITS” button. Select the designated Aulisa sensor module.
  • Page 35 NOTE: Alarm limits can be adjusted only when the Aulisa sensor module(s) is paired. NOTE: In an alarm event, ʻʻALARM LIMITSʼʼ button will appear after you select "AUDIO PAUSE" button or "AUDIO OFF" button. Step 3: To turn alarms on or off, tap on ʻʻON/OFFʼʼ button. (Turn on the alarm before adjusting the value.)
  • Page 36 NOTE: max limit is turned off by default. NOTE: There is no alarm setting for pulse amplitude. NOTE: TEMP min limit is turned off by default. NOTE: Select designated Unit of TEMP, °C or °F, 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.
  • Page 37 NOTE: The minimum alarm limit cannot exceed the maximum alarm limit, even if the maximum alarm limit is turned off. For example, if the maximum SpO limit is turned off but was previously set at 90%, the minimum SpO limit cannot be set higher than 90%.
  • Page 38: Alarm Delay Feature (For Oximeter Module Only)

    Alarm Delay Feature (for Oximeter Module only) In the traditional alarm management system, upper and lower alarm limits are set so alarms are issued at specific SpO levels. When the SpO level fluctuates near an alarm limit, each breach will trigger an alarm. This system monitors the gradient, the depth and the duration of SpO reduction as the factors to determine the alarm triggering delay.
  • Page 39: Care And Maintenance

    Receiver/Transponder will cause damage and void the warranty. If the Display Unit or Receiver/Transponder is not functioning properly, see “Troubleshooting” section for more information. For care and maintenance of Aulisa sensor module(s), refer to the Aulisa sensor module(s) Instructions for Use for additional instructions.
  • Page 40: Troubleshooting

    Aulisa by going online at www.aulisa.com under "Contact Us". CAUTION!!! This system is a precision electronic instrument and must be repaired by knowledgeable and specially trained Aulisa personnel only. Do not attempt to open the case or repair the electronics.
  • Page 41: Fcc Compliance

    FCC Compliance Declaration of Conformity with FCC for Electromagnetic Compatibility This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesignated operation.
  • Page 42 methods and procedures specified in OET Bulletin 65 Supplement C. The highest reported SAR for the device is 0.116 W/kg. When suing IEEE 802.11a wireless LAN, this product is restricted to indoor use, due to its operation in the 5.15 to 5.25GHz frequency range. The FCC requires 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.
  • Page 43: Service, Support, And Warranty

    Aulisa's place of repair as designated by Aulisa, and Aulisa is responsible for the cost of delivery back to the purchaser. Aulisa reserves the right to charge a fee for a warranty repair request on an Aulisa product that is found to be within...
  • Page 44: Privacy Policy

    Our Policy This privacy policy applies to personal information collected by Taiwan Aulisa Medical Devices Technologies, Inc. (“Aulisa”, “we”, “us” and/or “our”) from users of the Aulisa remote monitoring devices (the “Devices”). “Personal Information” includes any information that can be used on its own or with other information to identify or contact a single person or to identify an individual in context.
  • Page 45: Changes

    NOT USE THE DEVICES AND DO NOT SUBMIT ANY INFORMATION TO US. Access to and use of the Devices by a Provider who is an Aulisa customer (a “Customer”) and such Customer's authorized users is subject to and governed by the agreement between Aulisa and the applicable Customer executed by authorized representatives of each party (the “Customer Agreement”).
  • Page 46 Devices. Support Information If you contact Aulisa for support or to lodge a complaint, we may collect technical or other information from you. Such information will be used for the purposes of troubleshooting, customer support, software updates, and improvement of the Devices in accordance with this Privacy Policy.
  • Page 47 Personal Information we collect from you and the other information provided to us. This research may be compiled and analyzed on an aggregate basis, and Aulisa may share this research and related information in aggregated, de-identified and/or anonymized format with its affiliates, agents and other healthcare research and services entities, including without limitation insurance and pharmaceutical companies.
  • Page 48 With Related Companies: We may also share Personal Information with Aulisa Related Companies for purposes consistent with this Privacy Policy. With Our Agents, Consultants and Related Third Parties: Aulisa, like many businesses, sometimes hires other companies to perform certain business-related functions.
  • Page 49 NEVER respond to any e-mail requesting such information. If you receive such an e-mail purportedly from Aulisa, DO NOT RESPOND to the e-mail and DO NOT CLICK on any links and/or open any attachments in the e-mail, and notify Aulisa support at information@aulisa.com.
  • Page 50 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.
  • Page 51 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 52: Specifications

    Specifications Display Unit Display Panel 10.1” IPS Touch Panel Power Requirements Mains 100-240V AC 50-60 Hz DC Input 5V DC/AC adaptor Internal Power Battery Type 3.8V battery Battery Life 2 hours of continuous operation Dimensions 7.04” x 10.35” x 0.46” (179mm x 263mm x 11.8mm) Weight 21.87 oz (620g)
  • Page 53 Range 32.8 feet (10 meters) spherical radius Protocol Bluetooth 4.0 Direction Bi-direction Data rate Up to 100kbps Wi-Fi Protocol 802.11 b/g/n/ac, 2.4GHz/5GHz Direction Bi-direction...
  • Page 54: Parts And Accessories

    GA-CD0004 Receiver/Transponder GA-RT0001 Charging Adaptor (Receiver/Transponder) GA-CR0001 Refer to the Aulisa sensor module(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". CAUTION!!! Using accessories not by Taiwan Aulisa Medical Devices Technologies, Inc.

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