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Aulisa Guardian Angel Rx GA2000 Instructions For Use Manual

Digital vital sign monitoring system
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Aulisa Guardian Angel™ Rx GA2000
Digital Vital Sign Monitoring System
Instruction For Use
Version: 1.0

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Summary of Contents for Aulisa Guardian Angel Rx GA2000

  • Page 1 Aulisa Guardian Angel™ Rx GA2000 Digital Vital Sign Monitoring System Instruction For Use Version: 1.0...
  • Page 2 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

    Table of Contents GUIDE TO SYMBOLS ....................1 PRECAUTIONS FOR USE..................3 USING AULISA GA2000 DIGITAL VITAL SIGN MONITORING SYSTEM .....6 ........................... 7 NTENDED ........................ 7 RINCIPLE OF PERATION ........................... 8 YSTEM VERVI EW ..........................8 EVICE VERVI EW ..................10 ISPLAYS...

  • Page 4: Guide To Symbols

    Guide to Symbols Symbol Description Refer to instruction manual Type BF-Applied Part (patient isolation from electrical shock) Indicates separate collection for electrical and electronic equipment (WEEE). Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur in the vicinity of equipment marked with this symbol.
  • Page 5 Non-sterile Classification for water ingress and IP22 particulate matter...

  • Page 6: Precautions For Use

    Digital Vital Sign Monitoring System. Using other manufacturers’ sensors can result in improper pulse oximeter performance and patient injury may occur. 5. The operator must verify the compatibility of the sensor with Aulisa GA2000 Digital Vital Sign Monitoring System before use, otherwise patient injury can result.
  • Page 7 14. Use Aulisa GA2000 Digital Vital Sign Monitoring System only when the components are installed within the specified distances from the monitored patient – Sensor Module must be approximately 10 meters (10.9 yards) from the Receiver/Transponder (RT). Moving outside this range may cause missing, lost, and/or inaccurate data.
  • Page 8 14. Follow local governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. 15. Do not subject the system to extreme hot or cold temperatures, humidity, or direct sunlight. 16. Do not fasten the Sensor Module too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could result.

  • Page 9: Using Aulisa Ga2000 Digital Vital Sign Monitoring System

    Using Aulisa GA2000 Digital Vital Sign Monitoring System This chapter describes how to use Aulisa GA2000 Digital Vital Sign Monitoring System (hereinafter referred to as Aulisa GA2000 system). The system includes the following components and accessories: Sensor Module (2 pcs) Charging Adaptor - Sensor Module Charging Adaptor - Display Unit &...

  • Page 10: Intended Use

    Finger Sensor - Pediatric Wristband Intended Use The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate of adult and pediatric patients.

  • Page 11: System Overview

    System Overview NOTE: Aulisa GA2000 System utilizes a customer Wi-Fi network to communicate between RT and DU. The customer Wi-Fi network is to be implemented and managed by end users. Device Overview Sensor Module The Sensor Module includes a Bluetooth transmitter and a sensor, which is worn by the patient for vital sign monitoring.
  • Page 12 Receiver/Transponder The Receiver/Transponder features Bluetooth/Wi-Fi communication interfaces and an audio/video camera. It receives vital signs monitoring data from the Sensor Module via Bluetooth, integrates audio and video of the patient, and then converts the data to Wi-Fi signals, which are transmitted to and displayed by the Display Unit.

  • Page 13: Displays, Indicators, And Controls

    NOTE: Close the cover of charging port when the charging adaptor is not in use. Displays, Indicators, and Controls This section describes the display, indicators, and controls for the Aulisa GA2000 System. Display Icons and Indicators Blood Oxygen...
  • Page 14 Bluetooth Connection Status This icon displays whether the Sensor Module and RT are connected via Bluetooth. It will turn blue once the Sensor Module is paired with RT. Measurement Site Status This icon displays whether there is a finger inserted in the sensor. A system alarm will be displayed on the Display Unit if no fingers are detected.
  • Page 15 Wi-Fi Connection Indicator This icon indicates whether there is a connection between the Display Unit and customer Wi-Fi Network. Alarm Indicator This icon identifies an alarm condition exists. !!! represents high priority and !! represents medium priority Alarm Off This icon indicates that the alarm is turned off for the corresponding physiological condition.
  • Page 16 Return to Previous Screen Tap on this button on the top right corner of the MAIN screen to return to the previous page. Sleep Mode Tap on this button on the top left corner of the MAIN screen to let DU enter sleep mode. To wake up DU, tap on the blank screen and use finger to swipe to the right.
  • Page 17 Set Display Brightness In the settings menu, tap on this button to set the brightness of the display. Choose Theme In the settings menu, tap on this button to choose the desired theme. Set Wi-Fi Network of DU In the settings menu, tap on this button to select the desired customer Wi-Fi network for the Display Unit to link to.

  • Page 18: Setting Up Aulisa Ga2000 System

    Use the following procedure to set up the Aulisa GA2000 System: It is recommended to charge the Sensor Module fully prior to setting up Aulisa GA2000 System as it takes around 3 hours to fully charge and cannot be operated while charging (See “Powering and Charging” section on page 33 for more information).
  • Page 19 CAUTION! For long-term monitoring (over 3 hours of continuous use), the Display Unit must be connected to the charging adaptor. CAUTION! Do not plug the adaptor into a switched outlet to prevent accidental switching power off. 6. Establish a Wi-Fi connection between the Display Unit and RT. (See “System Connection”...
  • Page 20 10. Click the power On/ Off button to turn on the Sensor Module. NOTE: The power LED will light green when the power is ON. 11. Ensure the Sensor Module is paired with the Display Unit. (See “Bluetooth Connection” section on page 21 for more information. NOTE: Verify System Operation before every use.

  • Page 21: System Connection

    System Connection Wi-Fi Connection For first time users, use the following procedures to establish a Wi-Fi connection between the Display Unit and Receiver/ Transponder. Ensure DU and RT are turned on. (See “Powering and Charging” section on page 33 for more information). NOTE: The Wi-Fi Link LED on RT will blink red when there is no Wi-Fi connection established.
  • Page 22 Reset RT- Wi-Fi Connection When to reset RT- Wi-Fi Connection Re-installing Aulisa GA2000 system Wi-Fi connection problems between DU and RT Installing a new router in the customer Wi-Fi Network Use the following procedures to reset RT- Wi-Fi Connection: Ensure the DU and RT are turned on.
  • Page 23 NOTE: Beware of connecting to an unsecured network provides no security and exposes all your network traffic. NOTE: Ensure the customer Wi-Fi Network connection has a strong and reliable signal. NOTE: A QR code will be generated on the Display Unit for RT to scan.
  • Page 24 Bluetooth Connection The RT will automatically scan and connect to the Sensor Module from the same starter kit. NOTE: The Bluetooth connection status icon will turn blue once the RT is paired with the Sensor Module. NOTE: The status indicator of Sensor Module will blink green when link with Display Unit is established, and data is being transmitted.
  • Page 25 Verifying System Operation Use the following procedure to verify that the alarm systems are working properly. 1. Set up Aulisa GA2000 system according to instructions above (See “Setting up Aulisa GA2000 system” section on page 15 for more information) 2. Ensure there is a system connection established between the Sensor Module, RT and Display Unit.
  • Page 26 5. Verify that a SpO reading is displayed, that a pulse rate value appears, and that a PA reading is displayed. 6. Verify the live video is displayed on the MAIN screen.

  • Page 27: Shutting Off The System

    Shutting off the System Use the following procedure to shut down the Display Unit, the Sensor Module, and the Receiver/ Transponder. Display Unit 1. Press the power On/ Off button for at least one (1) second. (A display message will appear.) 2.

  • Page 28: Alarms And Limits

    Alarms and Limits This chapter describes alarms and limits for Aulisa GA2000 System. Alarms The Display Unit provides high and medium priority audible and visual alarms. High Priority Alarms High priority alarms are those that require immediate attention to the patient.
  • Page 29 Alarm limits may be adjusted by pressing ʻʻALARM LIMITSʼʼ button after silencing the alarms. (See “Adjusting Alarm Limits” section on page 29 for more information.) Medium Priority Alarms Medium priority alarms are those that signal potential problems with the equipment or other non-life-threatening situations. On the Display Unit, medium priority alarms are indicated with slow blinking yellow displays and with alarm text message.
  • Page 30 Medium priority audio alarms are: 3 beeps and 25-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 button to permanently turn off the alarm audio.
  • Page 31 WARNING! Silencing alarms does not mean the situation has been resolved. WARNING! Tapping on “AUDIO OFF” button will permanently silence the alarm audio of the current triggering alarm event. WARNING! A potential hazard exists if different alarm presets are used for the same or similar equipment in any single area.

  • Page 32: Adjusting Alarm Limits

    Adjusting Alarm Limits Follow the instructions below to review or set alarm limits. To restore alarm settings to default values, refer to “Default Alarm Settings.” 1. Ensure there is a system connection established between the Sensor Module, RT and Display Unit. (See “System Connection” section on 15 for more information) 2.
  • Page 33 3. To turn alarm limits on or off, tap on ʻʻON/OFFʼʼ button. (Turn on the alarm before adjusting the value.) NOTE: max limit is turned off by default. NOTE: There is no alarm setting for PA (pulse amplitude). 4. Tap on ʻʻ + ʼʼ or ʻʻ– ʼʼ buttons or drag the ʻʻseekbarʼʼ to adjust the values. NOTE: The minimum alarm limit cannot exceed the max alarm limit, even if the max alarm limit is turned off.
  • Page 34 the min SpO limit cannot be set higher than 90%. If you want to set min SpO limit at 90%, turn on the max SpO limit, set it above 90% and turn it off again as you wish. Note: The following table describes the default settings, adjustment ranges, and intervals.

  • Page 35: Default Alarm Settings

    Default Alarm Settings Follow the instructions below to restore alarm settings to default values. 1. Ensure there is a system connection established between the Sensor Module, RT and Display Unit (See “System Connection” section on page 18 for more information). NOTE: Default alarm settings can be restored only when the system connection is established.

  • Page 36: Charging The Sensor Module

    Powering and Charging Charging the Sensor Module Charge the Sensor Module with the charging adaptor (white) by following the steps below. NOTE: The Display Unit will alarm the user when the Sensor Module is low on battery. Once on low battery, the Sensor Module will work for up to another 2 hours (working time on low battery depends on user) Plug the mini-USB end of the cable into the charging port on the...
  • Page 37 MAIN screen of the Display Unit. NOTE: The Sensor Module cannot be used to measure vital signs while it is being charged CAUTION! Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.

  • Page 38: Powering The Display Unit

    Display Unit and plug the wall adaptor to a power outlet. Place the Display Unit on the stand provided. NOTE: The LED indicator will light red when charging and light blue when fully charged. CAUTION! Only use adaptors supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.

  • Page 39: Powering The Receiver/ Transponder

    NOTE: The battery low LED indicator will light yellow when the battery is low. CAUTION! Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.

  • Page 40: Care And Maintenance

    If the system is not functioning properly, see “Troubleshooting” section on page 38 for more information. The expected service life of Aulisa GA2000 System is 3 years. Cleaning and Disinfection Clean surface of and disinfect the finger sensor before each use. For surface cleaning and disinfection, follow the recommended actions below.

  • Page 41: Troubleshooting

    Troubleshooting Problem Possible Solution Click the power On/Off button. Cannot turn on the Sensor Fully charge the Sensor Module until the Module blue LED goes off. Press and hold the power On/Off button Cannot turn on the Display for at least three (3) seconds. Unit Make sure the power cord is properly connected to the outlet.
  • Page 42 Problem Possible Solution and Pulse Rate readings source. Apply the finger sensor to a finger without artificial or polished nails. Position the finger sensor at a different site. Make sure the finger sensor is attached to the finger securely. Make sure the finger sensor is securely attached to the Sensor Module.
  • Page 43 Problem Possible Solution Reset RT. If these solutions do not correct the problem, please contact your distributor, or contact Aulisa Customer Support at 1 (650) 813-1273 (USA). WARNING! This system is a precision electronic instrument and must be repaired by knowledgeable and specially trained Aulisa personnel only.

  • Page 44: Technical Information

    Bias is defined as the monitor under test reading minus the hemoximeter reading. Note: Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of Aulisa GA2000 Digital Vital Sign Monitoring System measurements can be expected to fall within ±A...
  • Page 45 from the clinical study Sensor Accuracy- GA-RS0001 90%-100% 1.70 80%-90% 1.44 70%-80% 2.06 – SaO The graph below shows the error (SpO ) plots of each subject GA-RS0004 measured by the sensor with upper and lower 95% limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers.
  • Page 46 Sensor Accuracy- GA- RS0004 90%-100% 1.39 80%-90% 1.77 70%-80% 2.08 – SaO The graph below shows the error (SpO ) plots of each subject measured by the GA- RS0001 sensor with upper and lower 95% limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers.
  • Page 47 30%, 20%, 10%, and 1%. All 880 combinations of testing points (=8 x 10 x 11) of Pulse Rate passed the ± 3% acceptance criteria. Equipment Response Time Aulisa GA2000 Digital Vital Sign Monitoring System uses a moving average to determine the Pulse Rate and SpO . The following table shows the equipment response time of Aulisa GA2000 Digital Vital Sign Monitoring System.

  • Page 48: S Declaration

    Manufacture’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 Guidance and manufacture’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 49 Mains power ±1 kV differential ±1 kV differential quality should be Surge mode mode that of a typical IEC 61000-4-5 commercial or ±2 kV common ±2 kV common hospital mode mode environment. ±0% UT in 0.5 ±0% UT in 0.5 cycle at 0°, 45°, cycle at 0°, 45°, 90°, 135°, 180°,...
  • Page 50 shall be calculated using the following equation: E = 6/d √ P Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.

  • Page 51: Fcc Compliance

    FCC RF exposure guidelines and should be avoided. The FCC requires the user to be notified that any changes or 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.
  • Page 52 For Display Unit & Receiver/Transponder 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 undesired operation.
  • Page 53 This warranty excludes cost of delivery to and from Aulisa. All repaired units shall be received by the purchaser at Aulisa place of business. Aulisa reserves the right to charge a fee for a warranty repair request on any Aulisa GA2000 Digital Vital Sign Monitoring System that is found to be within specifications.
  • Page 54 Aulisa personnel, tampering, or any kind of misuse or abuse of the system, shall void the warranty in its entirety. All non-warranty work shall be done according to Aulisa standard rates and charges in effect at the time of delivery to Aulisa.

  • Page 55: Specifications

    Specifications Aulisa GA2000 Digital Vital Sign Monitoring System Blood Oxygen Saturation 1% to 100% Display Range (SpO Pulse Rate Display Range 30 to 290 bpm Accuracy Blood Oxygen Saturation 70-100% ± 3 digits (%SpO ) (± 1 S.D.) Pulse Rate ±...
  • Page 56 Sensor Module (Sensors Integrated) Internal Power Battery 3.7 V battery Operating Life 22 hours of continuous operation Dimensions 0.7” H x 1.3” W x 2.7” D Without sensors 16 mm H x 32 mm W x 68 mm D Weight 1 ounce 28 grams Ingress Protection...

  • Page 57: Parts And Accessories

    Charging Adaptor- Display Unit & GA-CD0002 Receiver/Transponder For more information about Aulisa parts and accessories, contact your distributor, or contact Aulisa at 1 (650) 813-1273 (USA). WARNING! Using accessories not by Taiwan Aulisa Medical Devices Technologies, Inc. may result in inaccurate measurements.
  • Page 58 Taiwan Aulisa Medical Devices Technologies, Inc. No. 218-2, Chong Yang Rd. Nangang Dist, Taipei Taiwan Tel +886-2-2655-7297 www.aulisa.com © 2018 Taiwan Aulisa Medical Devices Technologies, Inc.

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