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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 measures may be necessary, such as reorienting

or relocating the device.

b.

Over

the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V.

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Содержание Guardian Angel Rx

Страница 1: ...Instructions For Use ____________________________________________________________ 7MN00057 00 Guardian Angel Rx Infant Oximeter Module...

Страница 2: ...in 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...

Страница 3: ...le of Operation 9 Device Set Up 9 Device Pairing 12 Automatic Pairing 12 Manual Pairing 12 Device Power Off 13 Device Charging 13 Alarms 14 Care and Maintenance 14 Cleaning 14 Reuse Life 14 Troublesho...

Страница 4: ...3 Guide to Symbols...

Страница 5: ...4 MR Unsafe must not be used in an MRI environment...

Страница 6: ...2 A functional tester cannot be used to assess the accuracy of this device This device does not require calibration 3 This device readings may be affected by the use of an electrosurgical unit 4 Anem...

Страница 7: ...instructions 18 Failure to follow instructions and warnings may result in serious injury or death Cautions 1 This device complies with International Standard IEC 60601 1 2 2014 for electromagnetic com...

Страница 8: ...t use caustic or abrasive cleaning agents on the device 12 Do not gas sterilize or autoclave this device 13 Batteries might leak or explode if used or disposed of improperly 14 Follow local governing...

Страница 9: ...8 Device Overview Device Components Infant Oximeter Box Infant Oximeter Disposable Sensor Cable Infant Oximeter Reusable Sensor Cable Adhesive Patch Leg Band Charging Adaptor...

Страница 10: ...le is reusable Discard the Adhesive Patch after each use Device Intended Use The Aulisa Infant Oximeter Module is intended to measure SpO2 and pulse rate of infant patients during non motion and under...

Страница 11: ...with Infant Oximeter Disposable Sensor Cable peel off the release paper on the sensor first and wrap the adhesive patch around the toe If you go with Infant Oximeter Reusable Sensor Cable peel off th...

Страница 12: ...he MAIN screen NOTE The power LED will light green when the power is ON NOTE Refer to the Instructions for Use of Guardian Angel Rx Digital Vital Sign Monitoring System for set up instructions and ver...

Страница 13: ...er Box Step 4 Press CONFIRM if the serial number SN displayed matches with the one on the Infant Oximeter Box Step 5 To confirm that the process was successful ensure that the Bluetooth connection sta...

Страница 14: ...power outlet NOTE The device remains paired with the system until the serial number is deleted from the list NOTE The device must be placed within 32 8 feet 10 meters to Guardian Angel Rx Digital Vit...

Страница 15: ...imes of cleaning within 1 5 years of re use life Do not use the device that has exceeded its re use life We recommend you clean and disinfect the device with the instructions below First lightly wipe...

Страница 16: ...egrade and do harm to the user CAUTION Do not pour or spray any liquids onto this device and do not allow any liquids to enter any openings in the device CAUTION Do not immerse the device in liquid an...

Страница 17: ...to rest comfortably without squeezing or pressing the sensor probe on a hard surface 7 Make sure the device is within 32 8 feet 10 meters spherical radius to the Guardian Angel Rx Digital Vital Sign M...

Страница 18: ...le and keep it motionless for at least 10 seconds 2 Relocate the sensor cable to a different site Cannot establish system connection 1 Make sure the device is within 32 8 feet 10 meters spherical radi...

Страница 19: ...hown are calculated per Bland JM Altman D 2007 Agreement between methods of measurement with multiple observations per individual Journal of Biopharmaceutical Statistics 17 571 582 Root mean square er...

Страница 20: ...ls with combinations of Pulse Amplitude settings of 0 5 1 3 5 7 10 12 15 17 and 20 and SpO2 settings of 100 95 90 85 80 75 and 70 All 1960 combinations of testing points 7 x 28 x 10 of Pulse Rate pass...

Страница 21: ...ent 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 a...

Страница 22: ...4 4 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV Line to Line 1 kV Line to Line...

Страница 23: ...22 Magnetic Field IEC 61000 4 8 characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC mains voltage before application of the test level...

Страница 24: ...the transmitter Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur...

Страница 25: ...iance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating thedevice b Over t...

Страница 26: ...nna 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 Consult the dealer or an e...

Страница 27: ...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 CAUTION No modifications to this d...

Страница 28: ...n the Warranty Period 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 Aul...

Страница 29: ...ttery Life 6 hours of continuous operation Temperature Operating 5 C to 40 C Storage Transportation 25 C to 70 C Humidity Operating 15 to 90 R H non condensing Storage Transportation 10 to 93 R H non...

Страница 30: ...29 Internally powered on battery power Type of Protection Type BF Applied Part Mode of Operation Continuous...

Страница 31: ...GA AD0001 Infant Oximeter Module Box Disposable Sensor Cable GA OM0011 Infant Oximeter Module Box Reusable Sensor Cable GA OM0009 You may also contact your distributor or contact Aulisa by going onlin...

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