Aulisa Guardian Angel Guardian Angel Lite GA1000 Series Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Aulisa Manuals
  4. Medical Equipment
  5. Guardian Angel GA1000 Series
  6. Instructions for use manual

Aulisa Guardian Angel Guardian Angel Lite GA1000 Series Instructions For Use Manual

Digital vital sign monitoring system
Hide thumbs Also See for Guardian Angel Guardian Angel Lite GA1000 Series:
Table of Contents

Advertisement

Quick Links

Download this manual
Digital Vital Sign Monitoring System
Instructions For Use
____________________________________________________________
7MN00026-02
Guardian Angel
Guardian Angel
GA1000 Series
®
®
Lite

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Guardian Angel Guardian Angel Lite GA1000 Series and is the answer not in the manual?

Questions and answers

Related Manuals for Aulisa Guardian Angel Guardian Angel Lite GA1000 Series

Summary of Contents for Aulisa Guardian Angel Guardian Angel Lite GA1000 Series

  • Page 1 Guardian Angel ® Guardian Angel ® Lite GA1000 Series Digital Vital Sign Monitoring System Instructions For Use ____________________________________________________________ 7MN00026-02...

  • 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

    Device Setting Up ......................16 Device Pairing ....................... 18 Automatic Pairing (Guardian Angel® only) ............18 Pairing 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 ....................

  • Page 4: Guide To Symbols

    Guide to Symbols Single Use...
  • Page 5 Date of Manufacture...

  • Page 6: Welcome

    Lite GA1000 Series Digital Vital Sign Monitoring System (“GA1000 Series”) by introducing the Display Unit/Aulisa mobile application which is intended for use in conjunction with a variety of Aulisa sensor module(s). Refer to the Instructions for Use of Aulisa sensor module(s) for detailed instructions.

  • Page 7: Ga1000 Series Function

    It is intended for adults, pediatrics, and infants. GA1000 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 provides visual and auditory alarms that alert the caregiver when a patient’s vital signs fall outside of pre-setting limits or when a technical event is detected.

  • Page 8: Precautions For Use

    Precautions for Use Use this device only within its designated range (approximately 32.8 feet (10 meters)— spherical radius— from Aulisa sensor module(s) to the Display Unit/mobile device). Moving outside this range may cause missing, lost, and/or inaccurate data. If this device fails to respond as described, discontinue use until the situation is corrected by qualified personnel.

  • Page 9: Device Components

    Device Components Display Unit Aulisa mobile application (“Aulisa Lite GA1000”) *Smartphone not included. Display Unit Stand Display Unit Charging Adapter (Type-C)

  • Page 10: Device Overview

    The Aulisa mobile application provides both iOS and Android version and serves as a substitute for the Display Unit when installed on personal mobile devices. Please download “Aulisa Lite GA1000”...
  • Page 11 RESTORE DEFAULTS Restore defaults of alarm setting Setting Item Description Enter a serial number of Aulisa sensor module(s) either Module Pairing by scanning the QR code or by key in the number manually. Adjust the alarm upper limit and lower limit of each Alarm Setting parameter.

  • Page 12: Display Unit

    Display Unit The Display Unit features a 10 1" LCD multi-touch display with Bluetooth technology. 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 13 A medium priority system alarm Display Unit will be displayed when the Display Unit battery level is low. These icons indicate 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 Press to edit user profile, User profile including name, weight, gender, date of birth, and location. This button appears when the Aulisa sensor module(s) is not connected to the Display Unit. Press the button to build a Establish system connection.
  • Page 15 In the setting menu, tap on this button to adjust the alarm limits for each aulisa sensor module. ALARM SETTING Set alarm limits Note: the alarm limits are adjustable only when the wireless connection is established.
  • Page 16 the button to clear the alarm of “bluetooth disconnected or power off”.

  • Page 17: Device Setting Up

    Step 2: Enable the Display Unit or Aulisa mobile application. If you’re using the Display Unit, follow Step 3 and 4 to power the device; if you’re using Aulisa mobile application, follow the onscreen instructions to complete the system setup.
  • Page 18 NOTE: Refer to “Device Pairing” section below for more information. NOTE: The 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.

  • Page 19: Device Pairing

    Step 1: In the Setting menu, select “(MODULE) PAIRING". Step 2: Scan the QR Code or key in the serial number located on the Aulisa sensor module(s). Step 3: Press “CONFIRM” if the serial number (SN) displayed matches with the one on the Aulisa sensor module(s).

  • Page 20: 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 screen is blue and the status indicator on Aulisa sensor module(s) is blinking green.

  • Page 21: Display Unit Power Off

    Step 1: Plug the Type-C end of the charging adaptor into the Display Unit. Step 2: Attach the wall adaptor to a power outlet. Step 3: Place the Display Unit on the stand provided. CAUTION!!! Only use adaptors supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.

  • Page 22: Alarms And Limits

    (see figure below). The alarm text message will be shown as pop-up notification on Aulisa mobile application. NOTE: Alarm LED indicator on the Oximeter Module/Infant Oximeter Module will blink...
  • Page 23 On the screen, medium priority alarms are indicated with slow blinking yellow displays and with alarm text message (see figure below). The alarm text message will be shown as pop- up notification on Aulisa mobile application.
  • Page 24 Display Unit or shown Oximeter module battery low as pop-up notification on Oximeter sensor cable/connection cable detached Aulisa mobile application. Alarm LED indicator on the Oximeter Module/Infant Oximeter module detection error Oximeter Module blinks yellow.
  • Page 25 (see figure below). The alarm text message will be shown as pop- up notification on Aulisa mobile application. CAUTION!!! Silencing alarms does not mean the situation has been resolved.

  • Page 26: Alarm Limits

    Follow the instructions below 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. Select the designated Aulisa sensor module.
  • Page 27 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 on the Display Unit 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 28 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 29 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 30: Alarm Delay Feature (For Oximeter Module/Infant Oximeter Module Only)

    Alarm Delay Feature (for Oximeter Module/Infant 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 31: Care And Maintenance

    Opening the Display Unit will cause damage and void the warranty. If the Display Unit 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 32: 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 33: Manufacturer's Declaration

    Manufacturer’s Declaration Refer to the following table for specific information regarding compliance to IEC 60601-1-2 for Display Unit. *For all EQUIPMENT and SYSTEMS Guidance and Manufacturer's Declaration - Electromagnetic Emission This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment.
  • Page 34 *For all EQUIPMENT and SYSTEMS Guidance and Manufacturer's Declaration - Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. IEC 60601-1-2 test Electromagnetic Immunity test...
  • Page 35 *For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and Manufacturer's Declaration - Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. IEC 60601-1-2 Electromagnetic environment Immunity test...
  • Page 36 abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V.

  • Page 37: Fcc Compliance

    FCC Compliance Declaration of Conformity with FCC for Electromagnetic Compatibility The Display Unit 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 38 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 39: 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 40: 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 41: 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 42 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 43 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 44 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 45 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 46 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 47 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 48: Specifications

    Specifications Display Unit (Guardian Angel® only) 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 49: Parts And Accessories (Guardian Angel® Only)

    GA-DU0003 Display Unit Stand GA-SD0002 Charging Adaptor GA-CD0004 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".

Table of Contents