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Aulisa Guardian Angel Rx GA2000, Instructions For Use Manual

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Aulisa Guardian Angel Rx GA2000 Instructions For Use Manual Download Page 3

 

 

 

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1

Precautions for Use

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3

11

Intended Use

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11

Principle of Operation
System Overview

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12
15

Device Overview

 

 

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21

Displays, Indicators, and Controls

 

 

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25
30
32

System Connection

 

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33

Alarms and Limits

Powering and Charging

 
 

34

44

Alarms

Charging the Oximeter Box

 
 

34

44

Powering the Display Unit

 

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38

46

Alarm Delay Function

Powering the Receiver/Transponder

42

47

 

 

 

 

 

 

 

 

43

Care and Maintenance
    

48

Troubleshooting

49

Technical Information

53

Service, Support, and Warranty

63

Specifications

71

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75

 

Cleaning and Disinfection

 

48

Guide to Symbols

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7

Table of
Contents

 

 

 

Device Performance

 

53

Manufacture's Declaration

 

FCC Compliance

 

55

60

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Summary of Contents for Guardian Angel Rx GA2000

Page 1: ...Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System Instructions For Use TM...

Page 2: ...manual shall imply Taiwan Aulisa Medical Devices Technologies Inc Aulisa is a registered trademark of Taiwan Aulisa Medical Devices Technologies Inc Read this entire manual carefully before using Aul...

Page 3: ...rging 34 44 Alarms Charging the Oximeter Box 34 44 Powering the Display Unit 38 46 Alarm Delay Function Powering the Receiver Transponder 42 47 43 Care and Maintenance 48 Troubleshooting 49 Technical...

Page 4: ...o instruction manual Indicates separate collection for electrical and electronic equipment WEEE Non ionizing electromagnetic radiation Equipment includes RF transmitters Interference may occur in the...

Page 5: ...Prescription use only Temperature limit NON STERILE Non sterile Date of Manufacturer Classification for water ingress and particulate matter IP22 Warning Charging Port 2...

Page 6: ...les are manufactured to meet the accuracy specifications for Aulisa GA2000 Digital Vital Sign Monitoring System Using other manufacturers sensor cables can result in improper pulse oximeter performanc...

Page 7: ...arterial oxygen saturation of functional hemoglobin Significant levels of dysfunctional hemoglobin such as methemoglobin might affect the accuracy of the measurement 13 Anemia may affect the accuracy...

Page 8: ...Sign Monitoring System fails to respond as described discontinue use until the situation is corrected by qualified personnel 4 Cardiogreen and other intravascular dyes may affect the accuracy of SpO2...

Page 9: ...ng instructions regarding disposal or recycling of the device and device components including batteries 16 Do not subject the system to extreme hot or cold temperatures humidity or direct sunlight 17...

Page 10: ...e 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 Pedia...

Page 11: ...Adult Oximeter Sensor Cable Wristband Pediatric Oximeter Sensor Cable 8...

Page 12: ...Stand Display Unit Charging Adaptor Oximeter Box Charging Adaptor Display Unit 9...

Page 13: ...Sticker Receiver Transponder Clamp Receiver Transponder Velcro Strap Receiver Transponder Charging Adaptor Receiver Transponder 10...

Page 14: ...eusable device Principle of Operation Aulisa GA2000 Digital Vital Sign Monitoring System measures SpO2 and pulse rate based on non invasive light emitting diode LED transmittance technology measuring...

Page 15: ...nt 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 1 2 3...

Page 16: ...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 1 2 4 5 6 Pow...

Page 17: ...beep made audible upon an alarm condition trigger event The Display Unit incorporates a talking and listening function that allows audio messages to be received and sent via the Receiver Transponder...

Page 18: ...s the window showing the pulse amplitude Pulse Amplitude When the vital signs cannot be measured the Display Unit shows dashes in each of the vital sign windows No data SpO2 This icon displays whether...

Page 19: ...m alarm will be displayed on the Display Unit when the Oximeter Box battery is low Battery Level of Oximeter Box These icons signify the battery level of the Display Unit A medium priority system alar...

Page 20: ...identifies an alarm condition exists represents high priority and represents medium priority Alarm Indicator This icon indicates that the alarm is turned off for the corresponding physiological condit...

Page 21: ...e MAIN screen to access the settings menu of the system Return to Previous Screen Tap on this button on the top right corner of the screen to return to the previous page Alarm History Tap on this butt...

Page 22: ...t Time Zone In the settings menu tap on this button to select the correct time zone for the Display Unit Connection Setup In the settings menu tap on this button to change the Wi Fi network of the Dis...

Page 23: ...riggered Tap on the button to temporarily silence the alarm audio of the current triggered alarm event for 2 minutes Turn Off Alarm Audio The button appears on the MAIN screen when an alarm is trigger...

Page 24: ...ns below to assemble the Receiver Transponder NOTE Securing the power cable to the holder with the Velcro strap can prevent the Receiver Transponder body from falling down when it accidentally falls o...

Page 25: ...the Display Unit 5 Follow the onscreen instructions on the Display Unit to complete the system setup See System Connection section on page 25 for more information NOTE On the top right of the MAIN scr...

Page 26: ...The wristband should be worn with the arrow indicator facing towards the patient s hand 8 Insert the Oximeter Box into the holder Attach the sensor probe to the thumb or finger making sure that the s...

Page 27: ...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 NOTE The Bluetooth connection status on the Display Un...

Page 28: ...iver Transponder plays a melody around a minute 4 Select a secure customer Wi Fi network from the list of available connections displayed on the Display Unit Enter the network security password Then p...

Page 29: ...SETTINGS icon Then tap on CONNECTION 2 Tap on DISPLAY UNIT 3 Select the desired Wi Fi network from the list of available connections displayed on the MAIN screen Enter the network security password T...

Page 30: ...ovides no security and exposes al your network traffic NOTE Ensure the customer Wi Fi network connection has a strong and reliable signal 5 Wait until the setting up of the Wi Fi connection for the Di...

Page 31: ...x NOTE Up to four Oximeter Boxes can be stored on the Display Unit 1 Ensure the desired Oximeter Box is turned on See Power and Charging section on page 44 for more information NOTE The power On Off L...

Page 32: ...olding the power On Off button for 3 seconds Wait until the Wi Fi Link LED lights red See Power and Charging section on page 47 for more information NOTE The power On Off LED on Receiver Transponder l...

Page 33: ...if an alarm message and audio signal is not generated 5 Press on the PAUSE AUDIO button to temporarily silence for 2 minutes 6 After alarm signal is regenerated press on the AUDIO OFF button to silenc...

Page 34: ...the Receiver Transponder connection indicator is lit blue and the Display Unit Wi Fi connection indicator has a strong signal 5 Verify that a SpO2 reading is displayed that a pulse rate value appears...

Page 35: ...o Talking Press and hold to send an audio message to patient 2 3 NOTE When patient privacy is desired follow the instructions below to place the sticker over the camera and microphone of Receiver Tran...

Page 36: ...on on the MAIN screen Oximeter Box Click the power On Off button to turn off the Oximeter Box NOTE When the power is turned off the power On Off LED lit green will turn off NOTE The Oximeter Box will...

Page 37: ...re those that require immediate attention to the patient They include SpO2 and pulse rate alarms On the Display Unit high priority alarms are indicated with rapid blinking vital sign readings in red c...

Page 38: ...y Unit NOTE The following table describes alarm conditions and visual indicators Alarm Condition Medium Priority Alarm Visual Indicator Sensor Probe Detached from Patient Oximeter Box Battery Low Sens...

Page 39: ...O X I M E T E R B O X B AT T E RY L O W John 36...

Page 40: ...exists if different alarm presets are used for the same or similar equipment in any single area Do not plug a headphone into headphone jack of the Display Unit as this will significantly reduce the v...

Page 41: ...tem 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 button NOTE Alarm limits can be adjuste...

Page 42: ...ff tap on ON OFF button Turn on the alarm before adjusting the value NOTE SpO2 max limit is turned off by default NOTE There is no alarm setting for pulse amplitude John PR bpm 150 50 40 PULSE RATE LO...

Page 43: ...s or drag the seekbar 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 SpO2 limit is turned off but...

Page 44: ...ned 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...

Page 45: ...lowing table lists the alarm triggering delay statistics for SpO2 Low Alarm Limit SpO2 Low Alarm Limit Maximum Delay seconds Average Delay seconds 74 20 7 6 50 16 6 4 5 4 90 86 90 81 85 76 80 75 Likew...

Page 46: ...ttings can be restored only when the system connection is established 2 Tap on SETTINGS button located on the top right corner of the MAIN screen 3 Tap on DEFAULT ALARM button 4 Tap on CONFIRM button...

Page 47: ...wing 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 batt...

Page 48: ...ge the Oximeter Box NOTE Verify operation of the system See Verifying System Operation section on page 30 for more information and check the battery status on the MAIN screen of the Display Unit NOTE...

Page 49: ...e and power the Display Unit The Display Unit will alarm the user when the Display Unit itself is low on battery 1 Plug the Type C end of the charging adaptor black with a Type C end into the Display...

Page 50: ...power outlet NOTE The AC power LED indicator will light green when AC adaptor is ON NOTE The charging LED indicator will light blue when internal battery is charging and will turn off when it is full...

Page 51: ...quids to enter any openings in the device Allow the unit to dry thoroughly before reuse Do not immerse the device in liquid and do not use caustic or abrasive cleaning agents on the device The advance...

Page 52: ...nnected to the outlet and the Display Unit Reposition the sensor probe or reinsert the finger and keep the hand motionless for at least ten 10 seconds Position the sensor probe at a different site All...

Page 53: ...e sure the sensor probe is attached to the finger securely Make sure the sensor cable is securely attached to the Oximeter Box Check the Display Unit for any alarms or error messages Check the sensor...

Page 54: ...system check system connections and retry Reposition the sensor probe or reinsert the finger and keep the hand motionless for at least ten 10 seconds Insert the sensor probe to a finger without finge...

Page 55: ...Wi Fi network that may prevent the system from establishing a connection Turn off the system verify system connections and retry Ensure that the Oximeter Box is within 10 meters spherical radius to R...

Page 56: ...s of measurement with multiple observations per individual Journal of Biopharmaceutical Statistics 17 571 582 RMS Error SpO SaO 2 2 2 n Root mean square error RMS error is calculated as follows 1Bias...

Page 57: ...e accuracy has been functionally tested against an electronic pulse simulator at 30 50 80 100 150 200 250 and 290 bpm with combinations of Pulse Amplitude settings of 0 5 1 3 5 7 10 13 15 17 and 20 an...

Page 58: ...for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Guidance and Manufacturer s Declaration Electromagnetic E...

Page 59: ...ation Electromagnetic Immunity Immunity test Electromagnetic environment guidance 8 kV contact 15 kV air Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge I...

Page 60: ...4 11 Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environm...

Page 61: ...cified below The customer and or user of this device should ensure that it is used in such an environment Guidance and Manufacturer s Declaration Electromagnetic Immunity Immunity test Electromagnetic...

Page 62: ...h in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional m...

Page 63: ...the separation between the equipment and receiver 3 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected 4 Consult the dealer or an experienced rad...

Page 64: ...operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful inte...

Page 65: ...range of 5 15 to 5 25GHz to reduce the potential for harmful interference to co channel mobile satellite systems High power radar is allocated as the primary user of the 5 25 to 5 35GHz and 5 65 to 5...

Page 66: ...Service Support and Warranty Warranty under Contact Us 63...

Page 67: ...n Personal Information and we will protect it WE AT AULISA VALUE KEEPING YOUR PERSONAL INFORMATION CONFIDENTIAL AND USING IT SOLELY IN THE CONTEXT OF OUR MISSION TO PROVIDE CONTINUOUS MONITORING OF VI...

Page 68: ...65...

Page 69: ...its user demographics and behavior based on the 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...

Page 70: ...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...

Page 71: ...easonable physical technical and administrative security controls to maintain the security and integrity of your Personal Information to protect against any anticipated threats or hazards to the secur...

Page 72: ...information aulisa com 69...

Page 73: ...n the Device Information Submission by Minors If the Device is being utilized by a minor and the Devices are being used to monitor a minor you represent warrant and covenant that by agreeing to the te...

Page 74: ...se Rate 1 to 100 30 to 290 bpm 70 100 3 digits 3 Specifications Alarms SpO2 Default SpO2 Limit Upper Limit Lower Limit Alarm Limit Range Upper Limit Lower Limit Adjustment Step Pulse Rate Default Puls...

Page 75: ...11 b g n ac 2 4GHz 5GHz Bi direction Temperature Operating Storage Transportation 5 C to 40 C 25 C to 70 C Operating Altitude Operating Storage Transportation 15 to 90 non condensing 10 to 93 relative...

Page 76: ...Input 100 240 V AC 50 60 Hz 5 V DC AC adaptor Internal Power Battery Operating Life Dimensions Weight Wireless Communication Alarm Sound Pressure Ingress Protection 3 8 V battery 2 hours of continuou...

Page 77: ...imensions Body Stand Weight Body Stand Wireless Communication Ingress Protection 2 6 x 4 6 x 2 7 67 mm x 116 mm x 69 mm 3 5 x 3 6 x 1 3 90 mm x 91 mm x 32 mm 6 oz 171g 1 oz 33 g Bluetooth Wi Fi IP22 7...

Page 78: ...Charging Adaptor Oximeter Box Charging Adaptor Display Unit Charging Adaptor Receiver Transponder For more information about Aulisa parts and accessories contact your distributor or contact Aulisa by...

Page 79: ...7MN00005 01...

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