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Aulisa Guardian Angel Rx Guardian Angel Rx Lite GA2000 Series, Инструкция по эксплуатации

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GA2000 Series Intended Use 

GA2000 

Model GA2000 of Guardian Angel Rx / Guardian Angel Rx Lite GA2000 Series Digital 
Vital Sign Monitoring System is indicated for use in measuring, recording, and 
displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate 
(PR). The intended environments of use are hospitals, medical facilities, home care, 
and subacute environments. This system is a reusable device.   

The Adult/Pediatric Oximeter Module is indicated for spot-checking and/or 
continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion 
and under well-perfused conditions. 

GA2001 

Model GA2001 of Guardian Angel Rx / Guardian Angel Rx Lite GA2000 Series Digital 
Vital Sign Monitoring System is indicated for use in measuring, recording, and 
displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate 
(PR). The intended environments of use are hospitals, medical facilities, home care, 
and subacute environments. This system is a reusable device. 

The Infant Oximeter Module is indicated for spot-checking and/or continuous 
monitoring of SpO2 and PR of pediatrics and infants during non-motion and under 
well-perfused conditions. 

GA2002 

Model GA2002 of Guardian Angel Rx / Guardian Angel Rx Lite GA2000 Series Digital 
Vital Sign Monitoring System is indicated for use in measuring, recording, and 
displaying body temperature. The intended environments of use are hospitals, 
medical facilities, home care, and subacute environments. This system is a reusable 
device. 

The Thermometer Module is indicated for continuous armpit body temperature 
monitoring of adults, pediatrics, and infants. 

GA2100 

Model GA2100 of Guardian Angel Rx / Guardian Angel Rx Lite GA2000 Series Digital 
Vital Sign Monitoring System is indicated for use in measuring, recording, and 
displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate 
(PR) and body temperature. The intended environments of use are hospitals, medical 
facilities, home care, and subacute environments. This system is a reusable device. 

The Adult/Pediatric Oximeter Module is indicated for spot-checking and/or 

Содержание Guardian Angel Rx Guardian Angel Rx Lite GA2000 Series

Страница 1: ...Digital Vital Sign Monitoring System Instructions For Use ____________________________________________________________ 7MN00022 02 Guardian Angel Rx Guardian Angel Rx Lite GA2000 Series...

Страница 2: ...l imply Taiwan Aulisa Medical Devices Technologies Inc Aulisa is a registered trademark of Taiwan Aulisa Medical Devices Technologies Inc Taiwan Aulisa Medical Devices Technologies Inc No 218 2 Chong...

Страница 3: ...Fi Network Initial Setup 26 Wi Fi Network Reset 27 Device Pairing 28 Automatic Pairing Guardian Angel Rx only 28 Pairing with a new Aulisa sensor module 28 Pairing with a new Receiver Transponder 29...

Страница 4: ...3 FCC Compliance 48 Service Support and Warranty 50 Specifications 51 Parts and Accessories 53...

Страница 5: ...4 Guide to Symbols Single Use MR Unsafe must not be used in an MRI environment...

Страница 6: ...5 Date of Manufacture...

Страница 7: ...ical or physiological events Aulisa mobile application The Aulisa mobile application can be installed on your mobile device as the display of the system to replace the Display Unit Please download Aul...

Страница 8: ...e Sensor Patch The Thermometer Box is embedded with a Bluetooth module and powered by a changeable button cell battery It is intended for adults pediatrics and infants GA2000 Series Function The Aulis...

Страница 9: ...onments This system is a reusable device The Infant Oximeter Module is indicated for spot checking and or continuous monitoring of SpO2 and PR of pediatrics and infants during non motion and under wel...

Страница 10: ...e in measuring recording and displaying functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate PR and body temperature The intended environments of use are hospitals medical facilitie...

Страница 11: ...d 8 Only use this device with charging adaptors provided by Aulisa 9 Do not immerse any part of the device in any liquids 10 Do not subject the device to extreme hot or cold temperatures humidity or d...

Страница 12: ...data transfer Alarm notifications will be triggered for such failure 15 It is recommended that the system works on an independent Wi Fi network and always use the Wi Fi network with WPA2 PSK security...

Страница 13: ...a mobile application Aulisa Lite GA1000 Smartphone not included Receiver Transponder Display Unit Stand Display Unit Charging Adapter Type C Receiver Transponder Charging Adapter Receiver Transponder...

Страница 14: ...serves as a substitute for the Display Unit when installed on personal mobile devices Please download Aulisa Lite GA1000 from App Store or Google Play Below table introduces the interface of the Auli...

Страница 15: ...er a serial number of Aulisa sensor module s either by scanning the QR code or by key in the number manually Alarm Setting Adjust the alarm upper limit and lower limit of each parameter User Profile F...

Страница 16: ...lay Unit Icon Name Description SpO2 Blood oxygen Blood oxygen saturation PR bpm Pulse rate Pulse rate beats per minute TEMP Body temperature Body temperature in either C or F Pulse amplitude PA Pulse...

Страница 17: ...indicates whether the oximeter sensor cable is connected to the oximeter box A system alarm will be displayed if the cable is disconnected Measurement Site Status This icon indicates whether the Infan...

Страница 18: ...ction Wi Fi Strength Indicator This icon indicates whether there is a strong connection for the customer Wi Fi Network Alarm Indicator This icon identifies an alarm condition exists represents high pr...

Страница 19: ...nction Press and hold this button on the MAIN screen to talk to the person being monitored Listening Function Tap on this button on the MAIN screen to receive audio of person being monitored via the R...

Страница 20: ...ure configured values Establish Pairing In the Setting menu tap on this button to pair to a new Aulisa sensor module or Receiver Transponder either by scanning the barcode or manually keying in the co...

Страница 21: ...20 Standby The button appears when the Infant Oximeter Module is detached from the foot Tap on the button to return to the Before You Start page STANDBY...

Страница 22: ...tal signs monitoring data from the Aulisa sensor module s via Bluetooth integrates audio and video of the person being monitored and then converts the data to Wi Fi signals which are transmitted to an...

Страница 23: ...22 Audio Video Feature Video View monitoring video Listening Tap to turn on and receive monitoring audio Talking Press and hold to send an audio message...

Страница 24: ...Connect the charging adaptor to the Receiver Transponder and a power outlet Step 2 You may simply place the Receiver Transponder on a table or follow the instructions below to assemble the holder and...

Страница 25: ...he wall c Ensure the Holder is secure Place the Receiver Transponder body on the Holder d Secure the power cable to the Holder with Velcro strap NOTE Securing the power cable to the holder with the Ve...

Страница 26: ...mation will appear on the MAIN screen NOTE The power LED will light green when the power is on CAUTION It is recommended to keep your mobile device plugged in when using Aulisa mobile application on y...

Страница 27: ...curity password and press CONFIRM Step 5 Create a password for the Receiver Transponder and press CONFIRM Step 6 Select the correct time zone and press CONFIRM for Display Unit only NOTE Beware of con...

Страница 28: ...displayed on the Display Unit Aulisa mobile application for Android user or key in the network name for iOS user Enter the network security password and press CONFIRM Step 4 Create a password for the...

Страница 29: ...ONFIRM if the serial number SN displayed matches with the one on the Aulisa sensor module s Step 5 To confirm that the process was successful ensure that the Bluetooth NOTE The Aulisa sensor module s...

Страница 30: ...tton of Receiver Transponder for 10 seconds until RESET is heard Wait for 1 minute until the Receiver Transponder plays a melody to proceed to the next step b Select the desired Wi Fi network from the...

Страница 31: ...nsecured 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 The Wi Fi Link LED on Receiver Transp...

Страница 32: ...or module s Instructions for Use for setting up instructions Step 2 Ensure the Bluetooth and Wi Fi connections are established respectively See Device Connection and Device Pairing sections Step 3 Set...

Страница 33: ...with the charging adaptor ALWAYS plugged in If the Display Unit has been disconnected from the charging adaptor proceed with the following steps to charge and power the Display Unit The Display Unit w...

Страница 34: ...p 2 Attach the wall adaptor to a power outlet NOTE The AC power LED indicator lights green when AC adaptor is plugged in NOTE The charging LED indicator lights blue during charging and goes off when f...

Страница 35: ...e that require immediate attention to the person being monitored including SpO2 pulse rate and temperature alarms On the screen high priority alarms are indicated with rapid blinking vital sign readin...

Страница 36: ...alarm audio for 2 minutes Tap on AUDIO OFF button to permanently silence the alarm audio See Alarm Limits section for adjusting the alarm limit Medium Priority Alarms Medium priority alarms are those...

Страница 37: ...ual Indicator Oximeter Sensor Probe Detached from the Finger 1 Alarm text message in yellow blinks rapidly on the screen 2 Alarm LED indicator on the Oximeter Module blinks yellow Oximeter Sensor Cabl...

Страница 38: ...has been resolved CAUTION Tapping on AUDIO OFF button will permanently silence the alarm audio of the current triggering alarm event CAUTION A potential hazard exists if different alarm presets are u...

Страница 39: ...et alarm limits Step 1 Ensure the system connection Bluetooth Wi Fi is established See Device Connection and Device Pairing sections Step 2 Tap on SETTING button on the MAIN screen and then tap on ALA...

Страница 40: ...ons or drag the seekbar to adjust the values OR tap on RESTORE DEFAULTS to restore alarm limits to manufacturer configured values NOTE Alarm limits can be adjusted only when the Aulisa sensor module s...

Страница 41: ...before adjusting the alarm limits CAUTION A potential hazard exists if different alarm presets are used for the same or similar equipment in any single area CAUTION When turned off the alarms will no...

Страница 42: ...ls High Priority Alarm Factory Default Adjustment Options Adjustment Interval SpO2 Upper Alarm Limit Off Off 85 100 1 SpO2 Lower Alarm Limit 85 Off 50 95 1 Pulse Rate Upper Alarm Limit Adult Pediatric...

Страница 43: ...s not possible Do not attempt to open the case Opening the Display Unit or Receiver Transponder will cause damage and void the warranty If the Display Unit or Receiver Transponder is not functioning p...

Страница 44: ...rm mode but no audible alarms can be heard 1 Wait for two 2 minutes and alarm tones will automatically re engage 2 Make sure no headphone is plugged in Cannot establish system connection 1 Make sure t...

Страница 45: ...ment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 This device uses RF energy only for its internal function Therefore its RF emissions are very low and...

Страница 46: ...hat of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV Line to Line 1 kV Line to Line Mains power quality should be that of a typical commercial or hospital environment Voltage d...

Страница 47: ...y an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF I...

Страница 48: ...47 abnormal performance is observed additional measures may be necessary such as reorienting or relocating thedevice b Over the frequency range 150 kHz to 80 MHz fieldstrengths should be less than 3 V...

Страница 49: ...relocate the receiving antenna 2 Increase 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...

Страница 50: ...equires 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 High power radar is allocated...

Страница 51: ...ii purchaser has returned the product to Aulisa in accordance with instructions provided on Aulisa s support webpage and iii Aulisa has verified that the product is defective Aulisa warrants a replac...

Страница 52: ...ressure 60dB Ingress Protection IP22 Receiver Transponder Power Requirements Mains 100 240V AC 50 60 Hz DC Input 5V DC AC adaptor Internal Power Battery Type 3 7V battery Battery Life 2 hours of conti...

Страница 53: ...otocol 802 11 b g n ac 2 4GHz 5GHz Direction Bi direction Classifications per IEC 60601 1 Type of Protection Class II MOPP on AC power Internally powered on battery power Type of Protection Type BF Ap...

Страница 54: ...dian Angel Rx only Refer to the Aulisa sensor module s Instructions for Use for more Aulisa sensor module s information You may also contact your distributor or contact Aulisa by going online at www a...

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