Guardian Angel
™
GA1000
Digital Vital Sign
Monitoring System
TM
Rx
Page 1: ...Guardian Angel GA1000 Digital Vital Sign Monitoring System TM Rx...
Page 2: ...this manual shall 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...
Page 3: ...Setting up Aulisa GA1000 System Device Pairing Verifying System Operation Shutting off the System Alarms Adjusting Alarm Limits Alarm Delay Feature Default Alarm Settings Charging the Oximeter Box Pow...
Page 4: ...and Type BF isolation Applied Part patient from electrical shock Non ionizing electromagnetic radiation Equipment includes RF transmitters Interference may occur in the vicinity of equipment marked w...
Page 5: ...ly on us Non sterile Temperature limit Lot number Classification for water ingress and particulate matter Charging Port IP22 Classification for water ingress and particulate matter Date of Manufacture...
Page 6: ...nufactured to meet the accuracy specifications for Aulisa GA1000 Digital Vital Sign Monitoring System Using other manufacturers sensor cables can result in improper device performance and patient inju...
Page 7: ...e percentage of arterial oxygen saturation of functional hemoglobin Significant levels of dysfunctional hemoglobin such as methemoglobin might affect the accuracy of the measurement 13 Use Aulisa GA10...
Page 8: ...ffect the accuracy of SpO measurements 2 4 The sensor probe might not work on cold extremities due to reduced circulation Warm or rub the finger to increase circulation or reposition the sensor probe...
Page 9: ...g 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 16 Do not fasten the Wristb...
Page 10: ...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 Oxim...
Page 11: ...8 Adult Oximeter Sensor Cable Wristband Pediatric Oximeter Sensor Cable...
Page 12: ...9 Charging Adaptor Oximeter Box Stand Display Unit Charging Adaptor Display Unit...
Page 13: ...t can be operated by the caregiver or by the patient System Overview The Guardian Angel Rx GA1000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxyge...
Page 14: ...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...
Page 15: ...it will display informational text messages alarm text messages and beep made audible upon an alarm condition trigger event 1 2 Power button Volume button 3 Charging port 1 2 3 NOTE It is recommended...
Page 16: ...not be measured the Display Unit shows dashes in each of the vital sign windows No data SpO2 When the vital sign values are inadequate the Display Unit shows beside the value Inadequate data This icon...
Page 17: ...ter Box These icons signify the battery level of the Display Unit A medium priority system alarm will be displayed on the Display Unit when the Display Unit battery is low Battery Level of Display Uni...
Page 18: ...ght corner of the 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 MAIN screen to return to the previous page Sleep Mod...
Page 19: ...manually pair the desired Oximeter Box to the Display Unit See Device Pairing section on page 22 for more information Set Alarm Limits Tap on this button on the MAIN screen to adjust the alarm limits...
Page 20: ...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 triggered Tap on...
Page 21: ...mation 1 Connect the charging adaptor black to the Display Unit and a power outlet 2 Press and hold the power On Off button for at least three 3 seconds to turn on the Display Unit For long term monit...
Page 22: ...use in patients weighing from 10 to 40 kilograms Adult Oximeter Sensor Cable is intended for use in patients weighing more than 40 kilograms Do not charge the device via this port Charging through th...
Page 23: ...t 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 ha...
Page 24: ...be established Once connected the vital signs and the Oximeter Box status information will appear on the MAIN screen See Device Pairing section on page 22 for more information NOTE The Bluetooth conne...
Page 25: ...o manually establish a connection between the Display Unit and the desired Oximeter Box 1 Ensure the desired Oximeter Box is turned on NOTE The desired Oximeter Box must be placed within 10 meters fro...
Page 26: ...ignal 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 silence permanently the alarm signal...
Page 27: ...play Unit can also be put into sleep mode by pressing the SLEEP button on the top right corner of the MAIN screen Oximeter Box Click the power On Off button to turn off the Oximeter Box NOTE When the...
Page 28: ...from the speakers on the Display Unit High Priority Alarms High priority alarms are those that require immediate attention to the patient They include SpO and pulse rate alarms On the 2 Display Unit...
Page 29: ...other non life threatening situations On the Display Unit medium priority alarms are indicated with slow blinking yellow displays and with alarm text message NOTE Alarm LED indicator on the Oximeter B...
Page 30: ...AUDIO OFF button to permanently turn off the alarm audio Alarm limits may be adjusted by pressing ALARM LIMITS button after silencing the alarms See Adjusting Alarm Limits section on page 29 for more...
Page 31: ...IO 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 sing...
Page 32: ...ge 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 Tap on SETTINGS bu...
Page 33: ...30 In an alarm event ALARM LIMITS button will appear after you select AUDIO PAUSE button or AUDIO OFF button...
Page 34: ...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 When turned off the alarms will no longer be displayed...
Page 35: ...able describes the default settings adjustment ranges and intervals High Priority Alarm SpO Upper Alarm Limit 2 SpO Lower Alarm Limit 2 Pulse Rate Upper Alarm Limit Pulse Rate Lower Alarm Limit Factor...
Page 36: ...ble lists the alarm triggering delay statistics for SpO Low Alarm Limit 2 NOTE A countdown timer and AUDIO OFF button will be displayed on the MAIN screen when the alarm limit has been breached and th...
Page 37: ...onnection 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 to restore alarm limits to manufacturer confi...
Page 38: ...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 1...
Page 39: ...e the Oximeter Box NOTE Verify operation of the system See Verifying System Operation section on page 23 for more information and check the battery status on the MAIN screen of the Display Unit NOTE T...
Page 40: ...t 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 into the Display Unit 2 Attach the wall adaptor to a power out...
Page 41: ...ng System is 18 months Clean surface of and disinfect the sensor cable before each use For surface cleaning and disinfection follow the recommended actions below Clean the surface of the sensor cable...
Page 42: ...be at a different site Allow the hand to rest comfortably without squeezing or pressing the sensor probe on a hard surface Make sure the Oximeter Box is within 10 meters 32 8 feet spherical radius to...
Page 43: ...meter Box is within 10 meters 32 8 feet spherical radius to the Display Unit and that the devices are paired Unstable Constant SpO and Pulse 2 Rate readings Reposition the sensor probe or reinsert the...
Page 44: ...nnect the device Turn off both the Oximeter Box and the Display Unit Follow instructions in the Device Pairing section on page 22 The unit is in Alarm mode but no audible alarms can be heard If these...
Page 45: ...measurement with multiple observations per individual Journal of Biopharmaceutical Statistics 17 571 582 RMS Error SpO SaO n Root mean square error RMS error is calculated as follows Bias is defined...
Page 46: ...e settings of 0 5 1 3 5 7 10 13 15 17 and 20 and SpO settings of 100 90 80 70 60 50 2 40 30 20 10 and 1 All 880 combinations of testing points 8 x 10 x 11 of pulse rate passed the 3 acceptance criteri...
Page 47: ...nternal 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 Emission Em...
Page 48: ...laration 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 Surg...
Page 49: ...000 4 11 Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 4 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital envir...
Page 50: ...dance and Manufacturer s declaration electromagnetic immunity Immunity test Electromagnetic environment guidance 3 V m 150 kHz to 80 MHz Conducted RF IEC 61000 4 6 IEC 60601 1 2 test level Compliance...
Page 51: ...ment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance le...
Page 52: ...ncouraged to try to correct the interference by one or more of the following measures 1 Reorient or relocate the receiving antenna 2 Increase the separation between the equipment and receiver 3 Connec...
Page 53: ...red operation Federal Communications Commission FCC Notice This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules These li...
Page 54: ...cy 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...
Page 55: ...as 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 replacement or repair...
Page 56: ...NG YOUR PERSONAL INFORMATION CONFIDENTIAL AND USING IT SOLELY IN THE CONTEXT OF OUR MISSION TO PROVIDE CONTINUOUS MONITORING OF VITALS IN ORDER TO AID PATIENTS HEALTHCARE PROVIDERS PROVIDERS AND CAREG...
Page 57: ...c No 218 2 Chong Yang Rd Nangang Dist 11573 Taipei City Taiwan The data controller is Taiwan Aulisa Medical Devices Provider Users Technologies Inc No 218 2 Chong Yang Rd Nangang Dist 11573 Taipei Cit...
Page 58: ...his Privacy Policy are defined in the documentation that came with your Devices What Information Do We Collect and Why Personal Data that You Provide Through the Devices We collect Personal Informatio...
Page 59: ...l 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 Polic...
Page 60: ...are described below If you are a Patient we will share your With Our Provider Customers Personal Information and Health Data with our Provider Customer s that provide healthcare services to you This w...
Page 61: ...ot contain any personal identifiers i e if the information has been anonymized by stripping out identifiers such as name address phone number etc The purpose of this type of disclosure is to allow res...
Page 62: ...eguards The information Aulisa collects and stores on secure servers is protected by a combination of technical administrative and physical security safeguards such as authentication encryption backup...
Page 63: ...s EU DATA SUBJECT RIGHTS If you are an EU you have the following rights under data subject certain circumstances to receive communications related to the processing of your personal data that are conc...
Page 64: ...s on 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...
Page 65: ...1 to 100 30 to 290 bpm 70 100 3 digits 3 Alarms SpO2 Default SpO Limit 2 Upper Limit Lower Limit Alarm Limit Range Upper Limit Lower Limit Adjustment Step Step Value Pulse Rate Default Pulse Rate Lim...
Page 66: ...er Type of Protection Type BF Applied Part Mode of Operation Continuous Measurement Wavelengths and Output Power Red Infrared Temperature Operating Storage Transportation Operating Altitude Atmospheri...
Page 67: ...8 mm 1 oz 28 g Weight Ingress Protection IP22 Display Unit Display Display panel Power Requirements 10 1 IPS Touch Panel Mains DC Input 100 240 V AC 50 60 Hz 5 V DC AC adaptor Internal Power Battery O...
Page 68: ...arging Adaptor Oximeter Box Charging Adaptor Display Unit For more information about Aulisa parts and accessories contact your distributor or contact Aulisa by going online at www aulisa com under Con...
Page 69: ...7MN00001 02...
