Related Manuals for Aulisa Guardian Angel Rx GA1001
Summary of Contents for Aulisa Guardian Angel Rx GA1001
- Page 1 Aulisa Guardian Angel™ Rx GA1001 Digital Vital Sign Monitoring System Instructions 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.
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Page 3: Table Of Contents
Table of Contents GUIDE TO SYMBOLS......................1 PRECAUTIONS FOR USE ..................... 3 USING AULISA GA1001 DIGITAL VITAL SIGN MONITORING SYSTEM ....... 5 ..........................6 NTENDED ......................6 RINCIPLE OF PERATION ........................6 YSTEM VERVIEW ........................7 EVICE VERVIEW ................... 8... -
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...
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Page 6: Precautions For Use
11. Anemia may affect the accuracy of the measurement. 12. Use Aulisa GA1001 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 Infant Oximeter Module to the Display Unit. - Page 7 2 meters (6.5 feet) away from the system. 3. If Aulisa GA1001 Digital Vital Sign Monitoring System fails to respond as described, discontinue use until the situation is corrected by qualified personnel.
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Page 8: Using Aulisa Ga1001 Digital Vital Sign Monitoring System
Using Aulisa GA1001 Digital Vital Sign Monitoring System This chapter describes how to use Aulisa GA1001 Digital Vital Sign Monitoring System (hereinafter referred to as Aulisa GA1001 system). The system includes the following components and accessories: Wireless Charging Case- Infant Oximeter... -
Page 9: Intended Use
(Black) Adhesive Patch- Infant Oximeter Module Intended Use The Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate. It is indicated for spot- checking and/or continuous monitoring of pediatrics and infants during non-motion and under well-perfused conditions. -
Page 10: Device Overview
Device Overview Display Unit The Display Unit features a 10.1” HD LCD multi- touch display with Bluetooth technology. The Display Unit displays real-time vital signs measured by the Infant Oximeter Module. The Display Unit will display informational text messages, alarm text messages, and beep audibly upon an alarm condition trigger event. -
Page 11: Displays, Indicators, And Controls
The Infant Oximeter Module must be used within 10 meters (32.8 feet) from the Display Unit. Displays, Indicators, and Controls This section describes the displays, indicators, and controls for Aulisa GA1001 System. Display Icons and Indicators Blood Oxygen... - Page 12 No data When the vital signs cannot be measured, the Display Unit shows dashes (- - -) in each of the vital sign windows. Inadequate data When the vital sign values are inadequate, the Display Unit shows (?) beside the value. Bluetooth Connection Status This icon displays whether the Infant Oximeter Module and the Display Unit are...
- Page 13 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. Audio Paused This icon indicates that the alarm audio is silenced for 2 minutes.
- Page 14 Device Pairing This button appears on the top right corner of the MAIN screen when the system is disconnected. Tap on the button to force the system to pair. NOTE: The Infant Oximeter Module must be placed within 10 meters (32.8 feet) from the Display Unit.
- Page 15 Restore Default Alarm In the settings menu, tap on this button to restore alarm limits to manufacture-configured values. Scan QR Code In the settings menu, tap on this button and scan the barcode on the back of the Infant Oximeter Module to manually pair the desired Infant Oximeter Module to the Display Unit.
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Page 16: Setting Up Aulisa Ga1001 System
Use the following procedure to set up the Aulisa GA1001 System: It is recommended to charge the Infant Oximeter Module fully prior to setting up Aulisa GA1001 System as it takes around 3 hours to fully charge. (See “Powering and Charging” section on page 27 for more information.) - Page 17 a. Remove the top paper liner of the adhesive patch b. Attach the top of the adhesive patch onto the back of the Infant Oximeter Module IMPORTANT! The clear window on the Infant Oximeter Module Adhesive Patch must align with the sensor probe of the Infant Oximeter Module.
- Page 18 a. Align the sensor probe on the center of the baby’s foot. b. Press and hold the end of the strap until it has adhered to the skin. c. Gently wrap the strap around the baby’s foot. d. Slightly fasten the strap. e.
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Page 19: Device Pairing
Device Pairing The Display Unit will automatically scan and connect to the Infant Oximeter Module 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 Bluetooth connection status icon will turn blue once the Display Unit is paired with the Infant Oximeter Module. -
Page 20: Verifying System Operation
Use the procedure below to monitor the readings (SpO , pulse rate, pulse amplitude) to verify that the device is functioning properly. 1. Set up Aulisa GA1001 system according to instructions above. (See “Setting up Aulisa GA1001 system” section on page 13 for more information.) 2. -
Page 21: Shutting Off The System
Shutting off the System Use the procedure below to shut down the Display Unit and the Infant Oximeter Module. 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 22: Alarms And Limits
Alarms and Limits This chapter describes alarms and limits for Aulisa GA1001 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 23 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. Alarm LED indicator on the Infant Oximeter Module will blink NOTE: red along with displays on the Display Unit.
- Page 24 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 25 CAUTION! Do not plug a headphone into the headphone jack of the Display Unit, as this will significantly reduce the volume of alarm audio.
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Page 26: 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” section on page 26 for more information. 1. Ensure there is a connection established between the Display Unit and the Infant Oximeter Module. - Page 27 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 28 NOTE: The SpO and pulse rate upper and lower alarm limits appear as smaller values to the top right and bottom right of their respective window on the MAIN screen. WARNING! The new ALARM LIMITS do not go into effect until the “CONFIRM”...
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Page 29: Default Alarm Settings
Default Alarm Settings Follow the instructions below to restore alarm settings to default values. 1. Ensure there is a connection established between the Display Unit and the Infant Oximeter Module. (See “Device Pairing” section on page 16 for more information.) NOTE: Default alarm can be restored only when the connection is established. -
Page 30: Powering And Charging
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 31: Charging The Infant Oximeter Module
Charging the Infant Oximeter Module Charge the Infant Oximeter Module with the wireless charging case by following the steps below. NOTE: The Display Unit will alarm the user when the Infant Oximeter Module is low on battery. Once on low battery, the Infant Oximeter Module will work for up to another 2 hours (working time on low battery depends on user) Connect the GA-CS0001 Charging Adaptor- Wireless Charging... - Page 32 CAUTION! Only use the charging adaptor and wireless charger supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.
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Page 33: Care And Maintenance
If the system is not functioning properly, see “Troubleshooting” section on page 31 for more information. The expected service life of Aulisa GA1001 System is 1.5 year. Cleaning Clean surface of the sensor probe before each use. Clean the surface of the sensor probe with a soft cloth dampened with rubbing alcohol. -
Page 34: Troubleshooting
Troubleshooting Problem Possible Solution Fully charge the Infant Oximeter Module until the charging blue light goes off, then remove Cannot turn on the SM from the wireless charger. Infant Oximeter Make sure the Infant Oximeter Module is kept Module away from any magnetic devices while charging. - Page 35 (approximately 10 meters (32.8 feet) spherical radius). 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.
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Page 36: Technical Information
– SaO The graph below shows the error (SpO ) plots of each subject measured by the Aulisa GA1001 System with upper and lower 95% limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers. - Page 37 (=7 x 28 x 10) of Pulse Rate passed the ± 3 digits acceptance criteria. Equipment Response Time Aulisa GA1001 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 GA1001 Digital Vital Sign Monitoring System.
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Page 38: Manufacture'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 39 that of a typical ±2 kV common ±2 kV common commercial or mode mode hospital environment. ±0% UT in 0.5 ±0% UT in 0.5 cycle at 0°, 45°, cycle at 0°, 45°, 90°, 135°, 180°, 90°, 135°, 180°, Voltage dips, short 225°, 270°...
- Page 40 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. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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Page 41: Fcc Compliance
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 42: Service, Support, And Warranty
Aulisa shall repair or replace any Infant Oximeter Module and integrated Sensor(s) and Display Unit found to be defective in accordance with this warranty, free of charge, for which Aulisa has been notified by the purchaser by serial number that there is a defect, provided said notification occurs within the applicable warranty period. - Page 43 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.
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Page 44: Specifications
Specifications Aulisa GA1001 Digital Vital Sign Monitoring System Blood Oxygen Saturation 1% to 100% Display Range (SpO Pulse Rate Display Range 30 to 300 bpm Accuracy Blood Oxygen Saturation 70-100% ± 3 digits (%SpO ) (± 1 S.D.) Pulse Rate ±... - Page 45 Atmospheric Pressure 700 hPa to 1013 hPa Humidity Operating 15% to 90%, non-condensing Storage/ Transportation 10% to 93% relative humidity, non- condensing Infant Oximeter Module (Sensors Integrated) Internal Power Battery 3.7 V battery Operating Life 22 hours of continuous operation 5.6”...
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Page 46: Parts And Accessories
GA-CD0002 Stand - Display Unit GA-SD0002 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 47 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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