Aulisa Guardian Angel Rx GA1001 Instructions For Use Manual Download Page 4

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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.

Manufacturer

Serial number

Lot number

Federal law (USA) restricts this device
to sale by or on the order of a licensed

health care professional only.

Temperature limit

Summary of Contents for Guardian Angel Rx GA1001

Page 1: ...Aulisa Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System Instructions For Use Version 1 0...

Page 2: ...he right to make changes and improvements to this manual and the products described within at any time without notice or obligation References to Aulisa in this manual shall imply Taiwan Aulisa Medica...

Page 3: ...E PAIRING 16 VERIFYING SYSTEM OPERATION 17 SHUTTING OFF THE SYSTEM 18 ALARMS AND LIMITS 19 ALARMS 19 ADJUSTING ALARM LIMITS 23 DEFAULT ALARM SETTINGS 26 POWERING AND CHARGING 27 POWERING THE DISPLAY U...

Page 4: ...or 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 Manufa...

Page 5: ...2 Non sterile IP22 Classification for water ingress and particulate matter...

Page 6: ...a damaged sensor If the sensor is damaged in any way discontinue use immediately and replace the sensor 8 Do not use in or around water or any other liquid when AC power adaptor is used 9 Only use Au...

Page 7: ...urements 5 The sensor might not work on cold extremities due to reduced circulation Warm or rub the foot to increase circulation or reposition the sensor 6 Aulisa GA1001 Digital Vital Sign Monitoring...

Page 8: ...al Vital Sign Monitoring System hereinafter referred to as Aulisa GA1001 system The system includes the following components and accessories Infant Oximeter Module Wireless Charging Case Infant Oximet...

Page 9: ...ts during non motion and under well perfused conditions The intended environments of use are hospitals medical facilities home care and subacute environments This system is a reusable device Principle...

Page 10: ...Oximeter Module The Display Unit will display informational text messages alarm text messages and beep audibly upon an alarm condition trigger event NOTE It is recommended that the Display Unit be pla...

Page 11: ...t 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 Indic...

Page 12: ...her the sensor is attached to the patient s foot A system alarm will be displayed on the Display Unit if no contact is detected between the sensor and the patient s foot Motion Indicator This animated...

Page 13: ...y Software Control Buttons Create Patient Profile Tap on this button on the MAIN screen to add a patient profile including name weight gender date of birth and location Edit Profile This button replac...

Page 14: ...ss the settings menu of the system Return to Previous Screen Tap on this button on the top right corner of the MAIN screen to return to the previous page Set Timezone In the settings menu tap on this...

Page 15: ...e Theme In the settings menu tap on this button to choose the desired theme Infant Oximeter Module Tutorial In the settings menu tap on this button to open the Infant Oximeter Module Tutorial Pause Al...

Page 16: ...d the power On Off button for at least three 3 seconds to turn on the Display Unit CAUTION For long term monitoring over 3 hours of continuous use the Display Unit must be connected to the charging ad...

Page 17: ...fant Oximeter Module Remove the bottom paper liner of the adhesive patch c Attach the bottom of the adhesive patch onto the back of the Infant Oximeter Module pressing down to smooth out the surface s...

Page 18: ...LED indicator will blink green when valid vital sign data is detected CAUTION Do not wrap the Infant Oximeter Module around the foot too tightly as it may affect blood circulation CAUTION Do not twis...

Page 19: ...the Display Unit and the desired Infant Oximeter Module 1 Ensure the desired Infant Oximeter Module is turned on NOTE The desired Infant Oximeter Module must be placed within 10 meters 32 8 feet from...

Page 20: ...O to temporarily silence for 2 minutes 6 After the alarm signal is regenerated press on the AUDIO OFF to silence permanently the alarm signal NOTE Alarm systems should be checked before use Use the pr...

Page 21: ...isplay Unit can also be put to sleep by pressing the SLEEP button on the top left corner of the MAIN screen Infant Oximeter Module Placing the Infant Oximeter Module inside the wireless charging case...

Page 22: ...alarm text message when alarm limits are met or exceeded NOTE Alarm LED indicator on the Infant Oximeter Module will blink red along with displays on the Display Unit High priority audio alarms are 3...

Page 23: ...isplays on the Display Unit The following table describes alarm conditions and visual indicators Alarm Condition Medium Priority Alarm Visual Indicator Sensor Probe Detached from Patient The Infant Ox...

Page 24: ...ion on page 23 for more information Multiple Alarms When there are high and medium priority alarms triggered simultaneously the system will display all the alarm text messages but will only sound the...

Page 25: ...22 CAUTION Do not plug a headphone into the headphone jack of the Display Unit as this will significantly reduce the volume of alarm audio...

Page 26: ...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 2 Tap on ALARM LIMITS button on the MAIN s...

Page 27: ...d off but was previously set at 90 the min SpO2 limit cannot be set high than 90 If you want to set min SpO2 limit at 90 turn on the max SpO2 limit set it above 90 and turn it off again as you wish NO...

Page 28: ...not go into effect until the CONFIRM button is tapped WARNING A potential hazard exists if different alarm presets are used for the same or similar equipment in any single area WARNING When turned off...

Page 29: ...2 Tap on SETTING button located on the top right corner of the MAIN screen 3 Tap on DEFAULT ALARM 4 Tap on CONFIRM to restore alarm limits to manufacturer configured values NOTE The following table d...

Page 30: ...he Display Unit The Display Unit will alarm the user when the Display Unit itself is low on battery 1 Insert the micro USB cable end of the GA CD0002 Charging Adaptor Display Unit into the Display Uni...

Page 31: ...and a power outlet 2 Open the cover of the wireless charging case and place the Infant Oximeter Module inside as shown below 3 Close the cover of the wireless charging case NOTE The power LED on the I...

Page 32: ...29 CAUTION Only use the charging adaptor and wireless charger supplied or manufactured by Taiwan Aulisa Medical Devices Technologies Inc...

Page 33: ...ctioning 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 C...

Page 34: ...rest comfortably without squeezing or pressing the sensor on a hard surface Relocate the Infant Oximeter Module at a different site Make sure the Infant Oximeter Module is within 10 meters 32 8 feet...

Page 35: ...eter Module is paired with the Display Unit The unit is in Alarm mode but no audible alarms can be heard Wait for two minutes and alarm tones will automatically re engage Make sure there are no headph...

Page 36: ...7 571 582 Root mean square error RMS error is calculated as follows RMS Error SpO2 SaO2 2 n 1 Bias is defined as the monitor under test reading minus the hemoximeter reading Note Because pulse oximete...

Page 37: ...nations of testing points 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 determin...

Page 38: ...es buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Complies Voltage fluctuations flicker Emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic...

Page 39: ...ains voltage before application of the test level Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and Manufacture s dec...

Page 40: ...ones 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 transmitt...

Page 41: ...r is connected 4 Consult the dealer or an experienced radio TV technician for help The device is designed and manufactured not to exceed the emission limits for exposure to radio frequency RF energy s...

Page 42: ...eplace 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...

Page 43: ...on warranty work shall be done according to Aulisa standard rates and charges in effect at the time of delivery to Aulisa DISCLAIMER EXCLUSIVITY OF WARRANTY The express warranties set forth in this ma...

Page 44: ...95 Adjustment Step Step Value 1 SpO2 Default Pulse Rate Limit Upper Limit 200 bpm Lower Limit 75 bpm Alarm Limit Range Upper Limit 75 275 bpm Lower Limit 30 110 bpm Adjustment Step Step Value 1 bpm Me...

Page 45: ...g Ingress Protection IP22 Display Unit Display Display panel 10 1 TFT Touch Panel Power Requirements Mains 100 240 V AC 50 60 Hz DC Input 5 V DC AC adaptor Internal Power Battery 3 7 V battery Operati...

Page 46: ...daptor Wireless Charging Case GA CS0001 Charging Adaptor Display Unit GA CD0002 Stand Display Unit GA SD0002 For more information about Aulisa parts and accessories contact your distributor or contact...

Page 47: ...44 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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