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Aulisa Guardian Angel Rx GA1000 Instructions For Use Manual

Digital vital sign monitoring system
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Guardian Angel
GA1000
TM
Digital Vital Sign
Monitoring System
Rx
™

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Summary of Contents for Aulisa Guardian Angel Rx GA1000

  • Page 1 Guardian Angel ™ GA1000 Digital Vital Sign Monitoring System...
  • Page 2 Read this entire manual carefully before using Aulisa GA1000 Digital Vital Sign Monitoring System. At the time of publication, this manual is believed to be accurate and up-to-date. In the interest of continued product development, Taiwan Aulisa Medical Devices 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.
  • Page 3 Indications for Use ..............Principle of Operation ................System Overview ................Device Overview ..........Displays, Indicators, and Controls ..........Setting up Aulisa GA1000 System ................Device Pairing ............Verifying System Operation ............Shutting off the System ................................Alarms ............
  • Page 4 Refer to instruction manual Type BF- Applied Part (patient isolation from electrical shock ) Indicates s arate collection for electric electronic equipment (WEEE). Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur in the vicinity of equipment marked with this symbol. anuf acturer al num...
  • Page 5 Lot number on us Prescripti e only Temperature limit Non-sterile Classification for water ingress and Classification for water ingress and IP22 IP22 particulate matter particulate matter Date of Manufacturer Caution Charging Port...
  • Page 6 3. This device is not a replacement for a caregiver. Warnings 1. Aulisa GA1000 Digital Vital Sign Monitoring System is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
  • Page 7 Significant levels of dysfunctional hemoglobin, such as methemoglobin, might affect the accuracy of the measurement. 13. Use Aulisa GA1000 Digital Vital Sign Monitoring System only when the components are installed within the specified distances from the monitored patient – approximately 10 meters (32.8 feet) spherical radius from the Oximeter Box to the wireless Display Unit.
  • Page 8 2. If Aulisa GA1000 Digital Vital Sign Monitoring System fails to respond as described, discontinue use until the situation is corrected by qualified personnel.
  • Page 9 13. Batteries might leak or explode if used or disposed of improperly. 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.

  • Page 10: Display Unit (Du)

    This chapter describes how to use Aulisa GA1000 Digital Vital Sign Monitoring System (hereinafter referred to as Aulisa GA1000 system). The system includes the following components and accessories* * The kit may come with different configurations of 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: Intended Use

    Intended Use The Guardian Angel Rx GA1000 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 14: 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 (32.8 feet) from the Display Unit.
  • Page 15 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 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 16: Displays, Indicators, And Controls

    Displays, Indicators, and Controls This section describes the displays, indicators, and controls for the Aulisa GA1000 System. Display Icons and Indicators 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 17 This icon displays whether the sensor cable is connected to the Oximeter Box. A system Sensor Cable alarm will be displayed on the Connection Status Display Unit if the cable is disconnected. These icons signify the battery level at Full, Medium, or Low. A medium priority system alarm Battery Level of will be displayed on the...
  • Page 18 Software Control Buttons Tap on this button on the top right corner of the MAIN screen System Settings to access the settings menu of the system. Tap on this button to edit a patient profile, including name, weight, Edit Profile gender, date of birth, and location.
  • Page 19 Tap on this button on the MAIN screen to adjust the alarm limits Set Alarm Limits for each vital sign. (See “Alarm and Limits” section on page 25 for more information on adjusting the alarm limits.) NOTE: The button is operable only when the wireless connection is established.
  • Page 20 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 21 Use the following procedure to set up the Aulisa GA1000 System: It is recommended to charge the Oximeter Box fully prior to setting up Aulisa GA1000 System as it takes around 3 hours to fully charge. (See “Powering and Charging” section on page 35 for more information) 1.
  • Page 22 Sensor Cable is intended for use in patients weighing more than 40 kilograms. Only use sensor cables supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. Do not charge the device via this port. Charging through this port will...
  • Page 23 5. Secure the wristband onto the patient's wrist with the holder facing outwards. Slip the velcro end through the hole and loop around to secure the wristband. Adjust the wristband according to wrist size, leaving proper space of about one or two fingers to allow ventilation. NOTE:The wristband should be worn with the arrow indicator facing towards the patient's hand.
  • Page 24 7. Click the power On/ Off button to turn on the Oximeter Box. NOTE:The power LED will light green when the power is ON. 8. Wait for the wireless connection between the Oximeter Box and the Display Unit to be established. Once connected, the vital signs and the Oximeter Box status information will appear on the MAIN screen.
  • Page 25 The Display will automatically scan and connect to the Oximeter Box from the same starter kit. If the connection is not established automatically, press "PAIR" button on the MAIN screen of the Display Unit to force the system to pair. NOTE:The Oximeter Box must be placed within 10 meters from Display Unit.
  • Page 26 Use the following procedure to verify that the alarm systems are working properly. 1. Set up Aulisa GA1000 system according to instructions above. (See “Setting up Aulisa GA1000 system” section on page 18 for more information.) 2. Ensure there is a wireless connection established between the Oximeter Box and Display Unit.
  • Page 27 Use the following procedure to shut down the Display Unit and the Oximeter Box. Display Unit 1. Press the power On/ Off button for at least one (1) second. (A display message will appear.) 2. Choose “Power off” on the display message to turn off the Display Unit.
  • Page 28 This chapter describes alarms and limits for Aulisa GA1000 System. 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.
  • Page 29 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.
  • 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 “PAUSE AUDIO” button to pause the alarm audio for 2 minutes. Tap on “AUDIO OFF” button to permanently turn off the alarm audio.
  • Page 31 NOTE:The volume for audio alarms cannot be adjusted. Silencing alarms does not mean the situation has been resolved. Tapping on "AUDIO OFF" button will permanently silence the alarm audio of the current triggering alarm event. A potential hazard exists if different alarm presets are used for the same or similar equipment in any single area.
  • Page 32 Follow the instructions below to review or set alarm limits. To restore alarm settings to default values, refer to “Default Alarm Settings” section on page 34 for more information. 1. Ensure there is a wireless connection established between the Oximeter Box and Display Unit. (See “Device Pairing” section on page 22 for more information.) 2.
  • Page 33 In an alarm event, ʻʻALARM LIMITSʼʼ button will appear after you select "AUDIO PAUSE" button or "AUDIO OFF" button.
  • Page 34 3. To turn alarm limits on or off, tap on ʻʻON/OFFʼʼ 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. A potential hazard exists if different alarm presets are used for the same or similar equipment in any area.
  • Page 35 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 limit cannot be set higher than 90%.
  • Page 36 SpO levels. When the SpO level fluctuates near an alarm limit, each breach will trigger an alarm. Aulisa GA1000 monitors the gradient, the depth and the duration of SpO reduction as the factors to determine the alarm triggering delay.
  • Page 37 1. Ensure there is a wireless connection established between the Oximeter Box and Display Unit. (See “Device Pairing” section on page 22 for more information.) NOTE:Default alarm settings can be restored only when the wireless connection is established. 2. Tap on “SETTINGS” button located on the top right corner of the MAIN screen.
  • Page 38 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 39 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 40 2. Attach the wall adaptor to a power outlet. 3. Place the Display Unit on the stand provided. NOTE:The LED indicator will light red when charging and light blue when fully charged. Only use adaptors supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.
  • Page 41 If the system is not functioning properly, see “Troubleshooting” section on page 39 for more information. The expected service life of Aulisa GA1000 Monitoring System is 18 months. Clean surface of and disinfect the sensor cable before each use.
  • Page 42 Problem Possible Solution Click the power On/Off button. Cannot turn on the Fully charge the Oximeter Box until the Oximeter Box 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.
  • Page 43 Problem Possible Solution Check the Display Unit for any alarms or error messages. Check the Oximeter Box for power. Check the sensor cable for any visible signs of deterioration. Shield the sensor probe from the light source. Insert the sensor probe to a finger without fingernail polish or an artificial nail.
  • Page 44 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 45 Note:Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of Aulisa GA1000 Digital Vital Sign Monitoring System measurements can be expected to fall within ±Arms of the value measured by a co-oximeter. from the Clinical Study...
  • Page 46 The graph below shows the error (SpO – SaO ) plots of each subject measured by the Aulisa GA1000 with upper and lower 95% limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers.
  • Page 47 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 48 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.
  • Page 49 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...
  • Page 50 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.
  • Page 51 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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 52 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 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. Declaration of Conformity with FCC for Electromagnetic Compatibility This device complies with Part 15 of the FCC Rules.
  • Page 54 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 55 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 specifications and without...
  • Page 56 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 57 IF YOU DO NOT AGREE, PLEASE DO 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...
  • Page 58 Changes: PLEASE NOTE THAT WE OCCASIONALLY UPDATE THIS PRIVACY POLICY AND THAT IT IS YOUR RESPONSIBILITY TO STAY UP TO DATE WITH ANY AMENDED VERSIONS. IF WE MODIFY THIS PRIVACY POLICY, WE WILL NOTIFY YOU OF THE CHANGES ON OUR WEBSITE, AN IN-SERVICE NOTICE OR OTHER REASONABLE MEANS.
  • Page 59 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 60 All of the information you share with us through the Devices is double-encrypted during transmission using AES-128 data encryption as well as an Aulisa private encryption method. Will You Share My Personal Information With Anyone Else? We consider your information to be a vital part of our relationship with you.
  • Page 61 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. When we employ another entity to perform a function of this nature, we only provide the entity with the information that it needs to perform its specific function.
  • Page 62 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 63 DO NOT CLICK on any links and/or open any attachments in the e-mail, and notify Aulisa support at information@aulisa.com. You are responsible for taking reasonable precautions to safeguard the Device from exposure to unauthorized third parties, and you are not permitted to circumvent the use of required encryption technologies.
  • Page 64 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 65 Aulisa GA1000 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 Pulse Rate ± 3% Alarms Default SpO Limit...

  • Page 66: Measurement Wavelengths And Output Power

    Measurement Wavelengths and Output Power 660 nanometers @ 1.8 mw nominal Infrared 905 nanometers @ 2 mw nominal Temperature Operating + 5°C to + 40°C Storage/Transportation – 25°C to + 70°C Operating Altitude altitude ≤ 3 000 m Atmospheric Pressure 700 hPa to 1013 hPa Humidity Operating...
  • Page 67 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” 16 mm x 32 mm x 68 mm Weight 1 oz 28 g Ingress Protection IP22 Display Unit Display Display panel 10.1”...
  • Page 68 Charging Adaptor - Oximeter Box GA-CS0001 Charging Adaptor- Display Unit GA-CD0004 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.
  • Page 69 7MN00001-02...