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Aulisa Guardian Angel Rx GA2000 Instructions For Use Manual

Digital vital sign monitoring system
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Guardian Angel Rx
GA2000
TM
Digital Vital Sign
Monitoring System
Instructions For Use
™

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Summary of Contents for Aulisa Guardian Angel Rx GA2000

  • Page 1 Guardian Angel Rx ™ GA2000 Digital Vital Sign Monitoring System Instructions For Use...
  • 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 ................Precautions for Use .................. Intended Use ..............Principle of Operation ................System Overview ................Device Overview ..........Displays, Indicators, and Controls ........................System Connection ....................................................... Alarms and Limits ....................

  • Page 4: Guide To Symbols

    Guide to Symbols 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. Manufacturer Serial number Lot number...
  • Page 5 Prescription use only Temperature limit Non-sterile STERILE Classification for water ingress and IP22 particulate matter Date of Manufacturer Warning Charging Port...
  • Page 6 3. Aulisa GA2000 Digital Vital Sign Monitoring System readings may be affected by the use of an electrosurgical unit. 4. Only use the sensor cables manufactured by Aulisa. These sensor cables are manufactured to meet the accuracy specifications for Aulisa GA2000 Digital Vital Sign Monitoring System.
  • Page 7 10. Do not use in or around water or any other liquid when AC power adaptor is used. 11.Only use Aulisa GA2000 Digital Vital Sign Monitoring System with charging adaptors provided by Aulisa. 12. Aulisa GA2000 Digital Vital Sign Monitoring...
  • Page 8 2 meters (6.5 feet) away from the system. 3. If Aulisa GA2000 Digital Vital Sign Monitoring System fails to respond as described, discontinue use until the situation is corrected by qualified personnel.
  • Page 9 components in any liquids. 12. Do not use caustic or abrasive cleaning agents on the device. 13. Do not gas sterilize or autoclave this pulse oximetry system. 14. Batteries might leak or explode if used or disposed of improperly. 15.Follow local governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.
  • Page 10 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*: *The system comes with either two Pediatric or two Adult Oximeter Sensor Cables.
  • Page 11 Adult Oximeter Sensor Cable Pediatric Oximeter Sensor Cable Wristband...
  • Page 12 Charging Adaptor- Oximeter Box Charging Adaptor- Display Unit Stand-Display Unit...
  • Page 13 Charging Adaptor- Receiver/Transponder Clamp- Receiver/Transponder Sticker- Receiver/Transponder Velcro Strap- Receiver/Transponder...

  • Page 14: Intended Use

    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. It is indicated for spot-checking and / or continuous monitoring of patients during non-motion and under well-perfused conditions.

  • Page 15: Device Overview

    Device Overview Oximeter Box The Oximeter box includes a Bluetooth transmitter and a sensor chip, which is worn by the patient for vital sign monitoring. It features a sensor chip, along with electronics for vital sign measuring and analyzing. The Oximeter Box must be used within 10 meters from the Receiver/Transponder.
  • Page 16 Receiver/Transponder The Receiver/Transponder features Bluetooth/Wi-Fi communication interfaces and an audio/video camera. It receives vital signs monitoring data from the Oximeter Box 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 17 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 the Oximeter Box. The Display Unit will display informational text messages, alarm text messages, and beep made audible upon an alarm condition trigger event.

  • Page 18: Displays, Indicators, And Controls

    Displays, Indicators, and Controls This section describes the displays, indicators, and controls for the Aulisa GA2000 System. Display Icons and Indicators Name This icon identifies the window Blood Oxygen showing the functional blood oxygen saturation in percent. This icon identifies the window Pulse Rate showing the pulse rate in bpm.
  • Page 19 Indicator Name Description This icon displays whether there is a finger inserted in the Measurement sensor. A system alarm will be Site Status displayed on the Display Unit if no fingers are detected. This icon displays whether the sensor cable is connected to the Oximeter Box.
  • Page 20 Indicator Name Description This icon indicates whether there is a strong connection Wi-Fi Strength between the Display Unit and Indicator customer Wi-Fi Network. This icon identifies an alarm condition exists. Alarm Indicator !!! represents high priority and !! represents medium priority This icon indicates that the alarm is turned off for the Alarm Off...
  • Page 21 Software Control Buttons Button Name Description Tap on this button on the MAIN screen to adjust the alarm limits for each vital sign. (See “Alarm and Limits” section on page 38 Set Alarm Limits for more information on adjusting ALARM LIMITS the alarm limits.) NOTE: The button is operable only when the system connection...
  • Page 22 Button Name Description In the settings menu, tap on this button to change the Wi-Fi network of the Display Unit or Connection Setup CONNECTION of the Receiver/Transponder, and to modify the password for the Receiver/Transponder. In the settings menu, tap on this button to pair to a new Oximeter Pair new Oximeter Box or Receiver/Transponder...
  • Page 23 Button Name Description This button appears on the MAIN screen when an alarm is Pause Alarm triggered. Tap on the button to Audio temporarily silence the alarm audio of the current triggered alarm event for 2 minutes. The button appears on the MAIN screen when an alarm is triggered.
  • Page 24 Use the following procedure to set up the Aulisa GA2000 System: It is recommended to charge the Oximeter Box 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”...
  • Page 25 Keep the Receiver/Transponder plugged in at all times. Caution! 2. Press and hold the power On/Off button for three (3) seconds to turn on the Receiver/Transponder. NOTE: The power On/Off LED will light green when the power is on. 3. Connect the charging adaptor (black with Type-C end) to the Display Unit and a power outlet.
  • Page 26 Only use sensor cables supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. Caution! Do not charge the device via this port. Charging through this port will cause permanent damage to the device. Caution! 7. Secure the wristband onto the patient's wrist with the holder facing outwards.
  • Page 27 9. Click the power On/Off button to turn on the Oximeter Box. NOTE: The power On/Off LED will light green when the power is on. 10. The Receiver/Transponder will automatically connect to a paired Oximeter Box under the control of the Display Unit. NOTE: The Oximeter Box must be placed within 10 meters (32.8 feet) from the Receiver/Transponder.

  • Page 28: System Connection

    System Connection Wi-Fi Network Setup First-Time Users Use the following procedures to establish a Wi-Fi connection between the Display Unit and the Receiver/Transponder: 1. Power the Display Unit and the Receiver/Transponder with their respective charging adaptors. (See “Powering and Charging” section on page 44 for more information.) 2.
  • Page 29 6. Select the correct time zone. NOTE: On the top right of the MAIN screen of the Display Unit, ensure the Receiver/Transponder connection indicator is lit blue and the Display Unit Wi-Fi connection indicator has a strong signal. Reset Wi-Fi Network For Display Unit Use the following procedures to change the Wi-Fi network of the Display Unit:...
  • Page 30 3. Press and hold the power On/ Off button of Receiver/Transponder for ten (10) seconds until “RESET” is heard. Wait until the Receiver/ Transponder plays a melody (around a minute). 4. Select the desired Wi-Fi network from the list of available connections displayed on the MAIN screen.
  • Page 31 Pairing Oximeter Box The system will automatically scan and pair to the Oximeter Box from the same starter kit only when the connection between the Display Unit and the Receiver/Transponder has been established. NOTE: The Oximeter Box must be used within 10 meters (32.8 feet) from the Receiver/Transponder.
  • Page 32 Receiver/Transponder Use the following procedure to manually setup pairing of a new Receiver/ Transponder: NOTE: Only one Receiver/Transponder can be stored on the Display Unit at a time. NOTE: The alarm event history on the Display Unit is managed via the Receiver/Transponder, so you won’t be able to see the current alarm event history when the Display Unit is paired to a new Receiver/ Transponder.
  • Page 33 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 21 for more information.) 2. Ensure there is a system connection established between the Oximeter Box, Receiver/Transponder and Display Unit.
  • Page 34 4. Verify that customer Wi-Fi network connection is stable. NOTE: On the top right of the MAIN screen, ensure the Receiver/ Transponder connection indicator is lit blue and the Display Unit Wi-Fi connection indicator has a strong signal. 5. Verify that a SpO reading is displayed, that a pulse rate value appears, and that a pulse amplitude reading is displayed.
  • Page 35 Audio/ Video Feature Jane Video: View patient's video Listening: Tap to turn on and receive patient’s audio Talking: Press and hold to send an audio message to patient NOTE: When patient privacy is desired, follow the instructions below to place the sticker over the camera and microphone of Receiver/Transponder.
  • Page 36 Shutting off the System Use the following procedure to shut down the Display Unit, the Oximeter Box, and the Receiver/Transponder. Display Unit 1. Press and hold the power On/Off button for at least one (1) second. (A display message will appear.) 2.

  • Page 37: Alarms And Limits

    Alarms 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. They include SpO and pulse rate alarms.
  • Page 38 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. NOTE: Alarm LED indicator on the Oximeter Box will blink yellow along with displays on the Display Unit.
  • Page 39 John O X I M E T E R B O X B AT T E R Y L O W...
  • Page 40 2019-06-03 16:24 John Smith John PR bpm PULSE RATE LOW O X I M E T E R B O X B AT T E R Y L O W NOTE: The volume for audio alarms cannot be adjusted. Silencing alarms does not mean the situation has been resolved. Tapping on “AUDIO OFF”...
  • Page 41 Follow the instructions below to review or set alarm limits. To restore alarm settings to default values, refer to “Default Alarm Settings.” 1. Ensure the system connection is established. (See “System Connection” section on page 25 more information.) 2. Tap on "SETTINGS" button on the MAIN screen, and then tap on “ALARM LIMITS”...
  • Page 42 John PR bpm PULSE RATE LOW 3. To turn alarm limits on or off, tap on “ON/OFF” button. (Turn on the alarm before adjusting the value.) NOTE: SpO max limit is turned off by default. NOTE: There is no alarm setting for pulse amplitude. 2019-06-03 16:24 John...
  • Page 43 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. For example, if the max SpO limit is turned off but was previously set at 90%, the min SpO...
  • Page 44 When turned off, the alarms will no longer be displayed or sound. Follow the instructions above to turn on the alarms. Consult a physician about the appropriate vital signlimits for the user before adjusting an alarm.

  • Page 45: Alarms

    SpO levels. When the level fluctuates near an alarm limit, each breach will trigger an alarm. Aulisa GA2000 monitors the gradient, the depth and the duration of SpO reduction as the factors to determine the alarm riggering delay.
  • Page 46 Follow the instructions below to restore alarm settings to default values. 1. Ensure there is a system connection established between the Oximeter Box, the Receiver/Transponder and the Display Unit. See “System Connection” section on page 25 more information.) NOTE: Default alarm settings can be restored only when the system connection is established.

  • Page 47: Charging The Oximeter Box

    Powering Charging Charging the Oximeter Box Charge the Oximeter Box with the charging adaptor (white) by following the steps below. NOTE: The Display Unit will alarm the user when the Oximeter Box is low on battery. Once on low battery, the Oximeter Box will work for up to another 2 hours (working time on low battery depends on user).
  • Page 48 MAIN screen of the Display Unit. NOTE: The Oximeter Box cannot be used to measure vital signs while it is being charged. Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.

  • Page 49: Powering The Display Unit

    2. Attach the wall adaptor to a power outlet. 3. Place the Display Unit on the stand provided. NOTE: Keep the Display Unit plugged in at all times. Only use adaptors supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.

  • Page 50: Powering The Receiver/Transponder

    NOTE: The battery low LED indicator will light yellow when the battery is low. (See “Device Overview” section on page 12 for more information.) Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.

  • Page 51: Care And Maintenance

    “Troubleshooting” section on page 48 for more information. The expected service life of Aulisa GA2000 System is 18 months. 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 52: Troubleshooting

    Troubleshooting Problem Possible Solution Click the power On/Off button. Cannot turn on the Oximeter Box Fully charge the Oximeter Box until the blue LED goes off. Press and hold the power On/Off button for at least three (3) seconds. Cannot turn on the Display Unit Make sure the power cord is properly connected to the outlet and the Display Unit.
  • Page 53 Problem Possible Solution Make sure the system connection is established. Reduce or eliminate any interference. Make sure that the finger sensor is not placed on the same wrist being used for other patient therapies or diagnostics (e.g. blood pressure cuff). Unable to obtain a Make sure the sensor probe is attached to valid SpO...
  • Page 54 Problem Possible Solution Make sure the sensor probe is attached to the finger securely. Make sure the sensor cable is securely Unstable/Constant attached to the Oximeter Box. and Pulse Rate readings Check the sensor cable for any visible signs of deterioration. Reduce patient motion.
  • Page 55 Aulisa by going online at www.aulisa.com under “Contact Us”. This system is a precision electronic instrument andmust be repaired by knowledgeable and specially trained Aulisa personnel only. Do not attempt to open the case or repair the electronics.

  • Page 56: 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 of the value measured by a co-oximeter.
  • Page 57 The graph below shows the error (SpO -SaO ) plots of each subject measured by the Aulisa GA2000 with upper and lower 95% limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers. Pulse Rate Accuracy...

  • Page 58: Manufacture's Declaration

    Manufacturer'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 Manufacturer's Declaration- Electromagnetic Emission This device is intended for use in the electromagnetic environment specified below.
  • Page 59 Guidance and Manufacturer's Declaration-Electromagnetic Immunity - 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. Electromagnetic Immunity test IEC 60601-1-2...
  • Page 60 Electromagnetic Immunity test IEC 60601-1-2 Compliance environment- test level level guidance Voltage dips, short interruptions, and voltage Mains power variations on quality should be power that of a typical supply input commercial or lines hospital environment. IEC 61000-4-11 Power Power frequency Frequency magnetic fields (50/60 Hz)
  • Page 61 Guidance and Manufacturer's Declaration-Electromagnetic Immunity-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. Electromagnetic Immunity test IEC 60601-1-2...
  • Page 62 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.

  • Page 63: Fcc Compliance

    FCC Compliance For Oximeter Box 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 64 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. For Display Unit & Receiver/Transponder Declaration of Conformity with FCC for Electromagnetic Compatibility This device complies with Part 15 of the FCC Rules.
  • Page 65 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 66: Service, Support, And Warranty

    Service, Support, and Warranty Warranty under “Contact Us”.
  • Page 67 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 patient 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 69 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...
  • Page 70 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. Examples of such functions include data hosting and billing management.
  • Page 71 If Aulisa learns of a security concern, we may attempt to notify you and provide information on protective steps, if available, through the e mail address that you have provided to us or other reasonable notification.
  • Page 72 information@aulisa.com.
  • Page 73 NOT accept this Privacy Policy and do not use the Devices on behalf of such minor. 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...

  • Page 74: 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 75 Measurement Wavelengths and Output Power 660 nanometers @ 1.8 mw nominal Infrared 905 nanometers @ 2 mw nominal Bluetooth Communication Range 10-meter spherical radius Protocol Bluetooth 4.0 Direction Bi-direction Data rate Up to 100kBps Wi-Fi Communication Protocol 802.11 b/g/n/ac, 2.4GHz/5GHz Direction Bi-direction Temperature...
  • Page 76 Oximeter Box Internal Power Battery 3.7 V battery Operating Life 22 hours of continuous operation Dimensions 0.7” x 1.3” x 2.7” Without sensors 16 mm x 32 mm x 68 mm Weight 1 oz 28 g Wireless Communication Bluetooth Ingress Protection IP22 Display Unit Display...
  • Page 77 Dimensions 2.6” x 4.6” x 2.7” Body 67 mm x 116 mm x 69 mm 3.5” x 3.6” x 1.3” Stand 90 mm x 91 mm x 32 mm Weight 6 oz Body 171g 1 oz Stand 33 g Bluetooth & Wi-Fi Wireless Communication IP22 Ingress Protection...
  • Page 78 GA-CS0001 Charging Adaptor-Display Unit GA-CD0004 Charging Adaptor-Receiver/Transponder GA-CR0001 For more information about Aulisa parts and accessories, contact your distributor, or contact Aulisa by going online at www.aulisa.com under “Contact Us”. Using accessories not by Taiwan Aulisa Medical Devices Technologies, Inc. may result in inaccurate measurements. Always use parts and...
  • Page 79 7MN00005-01...

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