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Guardian Angel Rx GA2000 TM Digital Vital Sign Monitoring System Instructions For Use Read this entire manual carefully before using Aulisa GA2000 Digital Vital Sign Monitoring System. Caution!
At the time of publication, this manual is believed to be accurate and up-to-date. In the interest of continued product development, Taiwan Aulisa Medical Devices Technologies, Inc. reserves the 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 Medical Devices Technologies, Inc. Aulisa is a registered trademark of Taiwan Aulisa Medical Devices Technologies, Inc. TM Taiwan Aulisa Medical Devices Technologies, Inc. No. 218-2, Chong Yang Rd., Nangang Dist. 11573 Taipei City , Taiwan Tel +886-2-2655-7297 Distributed by Aulisa Medical USA, Inc. 999 Commercial Street, Suite 208 Palo Alto, CA 94303,USA www.aulisa.com 2019 Taiwan Aulisa Medical Devices Technologies, Inc. Table of Contents Alarms and Limits Alarms Alarm Delay Function Guide to Symbols Precautions for Use Intended Use Principle of Operation System Overview Device Overview Displays, Indicators, and Controls System Connection
.............................................................................. ......................................................................... ..... ........................................................................... ................................................................... ......................................................................... .......................................................................... ............................................. ............................................. ..................................................................... .......................................................... ..................................................................... ............................................................... ............................................................................. ........................................................................................... ................................................................. ................................................................. ................................................................... ..................................................................... .......................................................... ........................................................... .......................................... ................................................................... ........................................................ ............................................................................. ....................................................................... ................................................................... ........................................................ ......................................................................... ................................................... .................................................................................. ...................................................................... Cleaning and Disinfection Care and Maintenance Troubleshooting Technical Information Device Performance Manufacture's Declaration FCC Compliance Service, Support, and Warranty Specifications Powering and Charging Charging the Oximeter Box Powering the Display Unit Powering the Receiver/Transponder 1 3 7 11 11 11 12 15 21 25 30 32 33 34 34 38 42 43 44 44 46 47 48 48 49 53 53 55 60 63 71 75 Guide to Symbols 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 1 Prescription use only Temperature limit NON STERILE Non-sterile IP22 Classification for water ingress and particulate matter Date of Manufacturer Warning Charging Port 2 Precautions for Use Contraindications 1. Do not use any part of this system in an MRI environment. 2. Explosion Hazard: Do not use this system in an explosive atmosphere or in the presence of flammable anesthetics or gases. 3. This device is not a replacement for a caregiver. Warnings 1. Aulisa GA2000 Digital Vital Sign Monitoring System is intended only as an adjunct in patient assessment. It must be used in with other methods of assessing clinical signs and symptoms. 2. A functional tester cannot be used to assess the accuracy of an oximeter sensor cable or an oximeter box. Aulisa GA2000 Digital Vital Sign Monitoring System does not require calibration. 3. Aulisa GA2000 Digital Vital Sign Monitoring System readings may be affected by the use of an electrosurgical unit. 4. Only use the sensor cables manufactured by Aulisa. These sensor cables 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 performance and patient injury may occur. 5. The operator must verify the compatibility of the sensor cable with Aulisa GA2000 Digital Vital Sign Monitoring System before use, otherwise patient injury can result. 6. As with all medical equipment, carefully route all cables to reduce the possibility of entanglement, Caution!
Warning!
3 strangulation or injury to the patient. 7. Be careful with small parts that can be removed from the device and swallowed, such as port covers. They are hazardous to children. 8. Excessive pressure to the sensor application site for prolonged periods may cause damage to the skin beneath the sensor. 9. Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor. 10. Do not use in or around water or any other liquid when AC power adaptor is used. 11.Only use Aulisa GA2000 Digital Vital Sign Monitoring System with charging adaptors provided by Aulisa. 12. Aulisa GA2000 Digital Vital Sign Monitoring System is designed to determine functional oxygen saturation, the percentage of 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 of the measurement. 14.Use Aulisa GA2000 Digital Vital Sign Monitoring System only when the components are installed within the specified distances from the monitored patient-Oximeter Box must be approximately 10 meters (10.9 yards) from the Receiver/
Transponder. Moving outside this range may cause missing, lost, and/or inaccurate data. 15. Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that no blood flow restrictors (e.g. blood pressure cuff) hinder pulse measurements. 16.This product is not a substitution for physician supervision. 17.Always refer to Instructions for Use for full warnings and instructions. 18.Failure to follow instructions and warnings may result in serious injury or death. 4 Cautions 1. This equipment complies with International Standard IEC 60601-1-2: 2014 for electromagnetic compatibility for medical electrical equipment and/
or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare, home care and other environments, it is possible that high levels of interference due to close proximity or strength of a source might disrupt the devices performance. 2. Radios and cell phones or similar devices can affect the wireless connection of the system and must be kept at least 2 meters (6.5 feet) away from the system. 3. If Aulisa GA2000 Digital Vital 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 measurements. 5. 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. 6. Aulisa GA2000 Digital Vital Sign Monitoring System might misinterpret motion as good pulse quality. Minimize motion of the monitored site. 7. Excessive ambient light may affect the accuracy of the measurement. 8. Some nail polish colors or artificial nails can reduce light transmission and affect SpO2 accuracy. 9. Inspect and relocate the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary due to medical status or skin condition. 10. Do not place liquids on top of the device. 11. Do not immerse the device or any of the Caution!
5 components in any liquids. 12. Do not use caustic or abrasive cleaning agents on the device. 13. Do not gas sterilize or autoclave this pulse oximetry system. 14. Batteries might leak or explode if used or disposed of improperly. 15.Follow local governing ordinances and recycling 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.Do not fasten the Wristband too tightly around the patient's wrist. Inaccurate readings and patient discomfort could result. 18.System connection failure (Bluetooth/ Wi-Fi wireless connection) may result in loss of data transfer. 19. The device is not for use during exercise. 6 Using Aulisa GA2000 Digital Vital Sign Monitoring System This chapter describes how to use 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 Pediatric or two Adult Oximeter Sensor Cables. Oximeter Box Display Unit Receiver/Transponder 7 Adult Oximeter Sensor Cable Pediatric Oximeter Sensor Cable Wristband 8 Charging Adaptor-
Oximeter Box Charging Adaptor-
Display Unit Stand-Display Unit 9 Charging Adaptor-
Receiver/Transponder Clamp-
Receiver/Transponder 10 Sticker-
Receiver/Transponder Velcro Strap-
Receiver/Transponder TM Intended Use The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and / or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environment of use is hospital, medical facilities, home care, and subacute environments. This system is a reusable 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 the absorbance of red and infrared light passed through the perfused tissue during each pulse. It can be operated by the caregiver or by the patient. System Overview Physiological data
(Bluetooth 4.0)
W i
F i 8 0 2
. 1 1
) Wi i Physiological data&
Audio/video data
) 1 1
. 2 0 F i 8
( W i -
NOTE: Aulisa GA2000 System utilizes a customer Wi-Fi network to communicate between the Receiver/Transponder and the Display Unit. The customer Wi-Fi network is to be implemented and managed by end users. 11 Device Overview Oximeter Box The Oximeter box includes a Bluetooth transmitter and a sensor chip, which is worn by 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 from the Receiver/Transponder. 2 1 3 4 SENSOR 5 Front View Back View 1 2 3 4 5 Power On/Off button Power On/Off LED Alarm LED Charging port Sensor cable port 12 Receiver/Transponder The Receiver/Transponder features Bluetooth/Wi-Fi communication interfaces and an audio/video camera. It receives vital signs monitoring 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. 2 1 3 Top View Power On/Off button Power On/Off LED 1 2 3 Wi-Fi Link LED 4 AC Power LED 5 6 7 Charging port Charging LED Battery Low LED 4 5 6 7 Front View Back View 13 Display Unit The Display Unit features a 10.1 LCD multi-touch display with Wi-Fi connectivity capability. The Display Unit displays real-time vital signs measured by the Oximeter Box. The Display Unit will display informational text messages, alarm text messages, and 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. Power On/Off button Volume button Charging port NOTE: It is recommended that the Display Unit be placed on the stand provided. NOTE: Only use fingers to operate keys on the touch screen. NOTE: Close the cover of charging port when the charging adaptor is not in use. 14 Displays, Indicators, and Controls This section describes the displays, indicators, and controls for the Aulisa GA2000 System. Display Icons and Indicators Name SpO2 %
Blood Oxygen This icon identifies the window showing the functional blood oxygen saturation in percent. bpm Pulse Rate This icon identifies the window showing the pulse rate in bpm. Pulse Amplitude This icon identifies the window showing the pulse amplitude. No data Pulse Amplitude Indicator When the vital signs cannot be measured, the Display Unit shows dashes- - -in each of the vital sign windows. This icon displays the pulse signal strength. NOTE: When the vital sign values are inadequate, the pulse amplitude indicator will turn yellow. Bluetooth Connection Status of Oximeter Box This icon displays whether the Oximeter Box is connected to the system via Bluetooth. It will turn blue once the Oximeter Box is paired with the system. 15 Indicator Name Description Measurement Site Status Sensor Cable Connection Status Battery Level of Oximeter Box Battery Level of Display Unit RT Receiver/
Transponder Connection Indicator This icon displays whether there is a finger inserted in the sensor. A system alarm will be displayed on the Display Unit if no fingers are detected. This icon displays whether the sensor cable is connected to the Oximeter Box. A system alarm will be displayed on the Display Unit if the cable is disconnected. These icons signify the battery level at Full, Medium, or Low. A medium priority system alarm will be displayed on the Display Unit when the Oximeter Box battery is low. 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. This icon indicates whether there is a connection established between the Display Unit and the Receiver/
Transponder. This icon will turn blue when there is a connection between the Display Unit and the Receiver/
Transponder and turn red when the connection is lost. 16 Indicator Name Description Wi-Fi Strength Indicator This icon indicates whether there is a strong connection between the Display Unit and customer Wi-Fi Network. Alarm Indicator This icon identifies an alarm condition exists.
!!! represents high priority and
!! represents medium priority Alarm Off This icon indicates that the alarm is turned off for the corresponding physiological condition. Audio Paused This icon indicates that the alarm audio is silenced for 2 minutes. Audio Off This icon indicates that the alarm audio is silenced permanently. 17 Software Control Buttons Button Name Description ALARM LIMITS Set Alarm Limits System Settings Tap on this button on the MAIN screen to adjust the alarm limits for each vital sign. (See Alarm and Limits section on page 38 for more information on adjusting the alarm limits.) NOTE: The button is operable only when the system connection is established. Tap on this button on the top right 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 screen to return to the previous page. Alarm History Tap on this button on the top right corner of the MAIN screen to view the alarm history list. Edit Profile Tap on this button to edit a patient profile, including name, weight, gender, date of birth, and location. Sleep Mode Tap on this button on the top right corner of the MAIN screen to let the Display Unit enter sleep mode. To wake up the Display Unit, use finger to swipe to the right. 18 Button Name Description CONNECTION Connection Setup Pair new Oximeter Box or Receiver/
Transponder PAIRING DEFAULT ALARM Restore Default Alarm Set Time Zone TIMEZONE BRIGHTNESS Set Display Brightness In the settings menu, tap on this button to change the Wi-Fi network of the Display Unit or of the Receiver/Transponder, and to modify the password for the Receiver/Transponder. In the settings menu, tap on this button to pair to a new Oximeter Box or Receiver/Transponder either by scanning the barcode or manually keying in the code found on the back of the said device.
(See System Connection section on page 25 for more information.) In the settings menu, tap on this button to restore alarm limits to manufacturer-configured values. In the settings menu, tap on this button to select the correct time zone for the Display Unit. In the settings menu, tap on this button to set the brightness of the display. Talking Function Press and hold this button to talk to the patient via the Display Unit. Listening Function Tap on this button to receive patient's audio via the Receiver/Transponder's microphone. 19 Button Name Description Pause Alarm Audio Turn Off Alarm Audio This button appears on the MAIN screen when an alarm is triggered. Tap on the button to temporarily silence the alarm audio of the current triggered alarm event for 2 minutes. The button appears on the MAIN screen when an alarm is triggered. Tap on the button to permanently silence the alarm audio of the current triggered alarm event. 20 Use the following procedure to set up the Aulisa GA2000 System:
It is recommended to charge the Oximeter Box fully prior to setting up Aulisa GA2000 System as it takes around 3 hours to fully charge and cannot be operated while charging (See Powering and Charging section on page 44 for more information.) 1. Connect the charging adaptor (black with a micro USB end) to the Receiver/Transponder and a power outlet. (See Power and Charging section on page 47 for more information.) Follow the instructions below to assemble the Receiver/Transponder. CLAMP ON THE FURNITURE STEP 1 Pull down the clip and slide the clamp into the holder. STEP 2 Check to ensure the clamp is secure. STEP 3 Clamp on furniture. Place the device on the holder. STEP 4 Secure the power cable to the holder with Velcro strap. HANG ON THE WALL STEP 1 Slide the clamp into the holder. STEP 2 Hang the holder on the wall. STEP 3 Check to ensure the holder is secure. Place the device on the holder. STEP 4 Secure the power cable to the holder with Velcro strap. 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 off the holder. 21 Keep the Receiver/Transponder plugged in at all times. Caution!
2. Press and hold the power On/Off button for three (3) seconds to turn on the Receiver/Transponder. NOTE: The power On/Off LED will light green when the power is on. 3. Connect the charging adaptor (black with Type-C end) to the Display Unit and a power outlet. (See Power and Charging section on page 46 for more information.) 4. Press and hold the power On/Off button for three (3) seconds to turn on the Display Unit. Keep the Display Unit plugged in at all times. Do not plug the adaptor into a switched outlet to prevent accidental switching power off. Caution!
Caution!
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 screen of the Display Unit, ensure the Receiver/Transponder connection indicator is lit blue and the Display Unit Wi-Fi connection indicator has a strong signal. RT 6. Assemble the Oximeter Module by attaching the connector end of sensor cable to the end marked with of the Oximeter Box. NOTE: Pediatric Oximeter Sensor Cable is intended for use in patients weighing from 10 to 40 kilograms. Adult Oximeter Sensor Cable is intended for use in patients weighing more than 40 kilograms. 22 Only use sensor cables supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. Do not charge the device via this port. Charging through this port will cause permanent damage to the device. Caution!
Caution!
7. Secure the wristband onto the patient's wrist with the holder facing outwards. Slip the velcro end through the hole and loop around to secure the wristband. Adjust 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 hand. 8. Insert the Oximeter Box into the holder. Attach the sensor probe to the thumb or finger, making sure that the sensor cable runs over the top of the patient's hand. 23 9. Click the power On/Off button to turn on the Oximeter Box. NOTE: The power On/Off LED will light green when the power is on. 10. The Receiver/Transponder will automatically connect to a paired 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 Unit will turn blue once the connection between the Oximeter Box and the system is established. NOTE: The power On/Off LED of Oximeter Box will blink green when the data are being transmitted. 24 System Connection Wi-Fi Network Setup First-Time Users Use the following procedures to establish a Wi-Fi connection between the Display Unit and the Receiver/Transponder:
1. Power the Display Unit and the Receiver/Transponder with their respective charging adaptors. (See Powering and Charging section on page 44 for more information.) 2. Press and hold the power On/ Off button for three (3) seconds to turn on the Receiver/Transponder. Wait until the Wi-Fi Link LED on the Receiver/
Transponder blinks red. 3. Press and hold the power On/ Off button of Receiver/Transponder for ten
(10) seconds until RESET is heard. Wait until the Receiver/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, press CONFIRM. NOTE: Beware of connecting to an unsecured 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: Wait until the setting up of the Wi-Fi connection for the Display Unit and the Receiver/Transponder has been completed. NOTE: The Wi-Fi Link LED on Receiver/Transponder will turn solid red, indicating the Wi-Fi connection has been established. 5. Create a password for the Receiver/Transponder. Then, press CONFIRM. NOTE: This step cannot be skipped. NOTE: The password must contain a combination of numbers and letters. 25 6. Select the correct time zone. NOTE: On the top right of the MAIN screen of the Display Unit, ensure the Receiver/Transponder connection indicator is lit blue and the Display Unit Wi-Fi connection indicator has a strong signal. Reset Wi-Fi Network For Display Unit Use the following procedures to change the Wi-Fi network of the Display Unit:
1. On the Display Unit, tap on the 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. Then, press CONFIRM. For Receiver/ Transponder Use the following procedures to reset the Receiver/Transponder to link to the desired Wi-Fi network:
NOTE: The Wi-Fi network of the Display Unit will be changed, together with that of the Receiver/Transponder. 1. On the Display Unit, tap on the SETTINGS icon, then tap on CONNECTION. 2. Tap on RECEIVER/TRANSPONDER. Then, tap on CONFIRM. 26 3. Press and hold the power On/ Off button of Receiver/Transponder for ten (10) seconds until RESET is heard. Wait until the Receiver/
Transponder plays a melody (around a minute). 4. Select the desired Wi-Fi network from the list of available connections displayed on the MAIN screen. Enter the network security password. Then, press CONFIRM. NOTE: Beware of connecting to an unsecured network provides 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 Display Unit and the Receiver/Transponder has been completed. NOTE: The Wi-Fi Link LED on Receiver/Transponder will turn solid red, indicating the Wi-Fi connection has been established. 6. Create a password for the Receiver/Transponder. Then, press CONFIRM. NOTE: This step cannot be skipped. NOTE: The password must contain a combination of numbers and letters. 7. Select the correct time zone. 27 Pairing Oximeter Box The system will automatically scan and pair to the Oximeter Box from the same starter kit only when the connection between the Display Unit and the Receiver/Transponder has been established. NOTE: The Oximeter Box must be used within 10 meters (32.8 feet) from the Receiver/Transponder. NOTE: The Bluetooth connection status icon on the Display Unit will turn blue once the Oximeter Box is paired. NOTE: The power On/Off LED on the Oximeter Box will blink green when the data are being transmitted. Use the following procedure to manually setup pairing of a new Oximeter Box:
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 LED on Oximeter Box lights green when the power is on. 2. In the settings menu of the Display Unit, select PAIRING. Then, select OXIMETER BOX. 3. Scan the QR Code or manually key in the serial number located on the back of the desired Oximeter Box. 4. Press CONFIRM if the serial number (SN) displayed matches with the SN on the back of desired Oximeter Box. 5. To confirm that the process was successful, ensure that the Bluetooth connection status icon on the MAIN screen of the Display Unit is lit blue. NOTE: The Oximeter Box must be used within 10 meters (32.8 feet) from the Receiver/Transponder. 28 Receiver/Transponder Use the following procedure to manually setup pairing of a new Receiver/
Transponder:
NOTE: Only one Receiver/Transponder can be stored on the Display Unit at a time. NOTE: The alarm event history on the Display Unit is managed via the Receiver/Transponder, so you wont be able to see the current alarm event history when the Display Unit is paired to a new Receiver/
Transponder. 1. Turn on the desired Receiver/Transponder by pressing and holding the power On/ Off button for 3 seconds. Wait until the Wi-Fi Link LED lights red. (See Power and Chargingsection on page 47 for more information.) NOTE: The power On/Off LED on Receiver/Transponder lights green when the power is on. 2. In the settings menu of the Display Unit, select PAIRING. Then, select Receiver/Transponder. 3. Scan the QR Code or manually key in the back of the desired Receiver/Transponder. CODE located on the 4. Press CONFIRM if the pairing code displayed matches with the CODE on the back of desired Receiver/Transponder. 5. Follow the onscreen instructions on the Display Unit to setup the Wi-Fi connection of the Receiver/Transponder. 29 Verifying System Operation Use the following procedure to verify that the alarm systems are working properly. 1. Set up Aulisa GA2000 system according to instructions above. (See Setting up Aulisa GA2000 system section on page 21 for more information.) 2. Ensure there is a system connection established between the Oximeter Box, Receiver/Transponder and Display Unit. (See System Connection section on page 25 for more information.) 3. Detach the sensor cable from Oximeter Box. 4. Verify that an alarm message is displayed and that an alarm audio is generated (See Troubleshooting section on page 49 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 silence permanently the alarm signal. NOTE: Alarm systems should be checked before use. Use the procedure below to monitor the readings (SpO2, pulse rate, pulse amplitude) in order to verify that the device is functioning properly. 1. Set up Aulisa GA2000 system according to instructions above (See Setting up Aulisa GA2000 system section on page 21 for more information.) 2. Press firmly on the application site to make sure it securely attached to the finger. 3. Verify the Bluetooth connection status icon on the Display Unit is blue and the power On/Off button on the Oximeter Box is blinking green. 30 4. Verify that customer Wi-Fi network connection is stable. NOTE: On the top right of the MAIN screen, ensure 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, and that a pulse amplitude reading is displayed. 6. Verify the live video is displayed on the MAIN screen. 31 Audio/ Video Feature Jane Video: View patient's video 2 Listening: Tap to turn on and receive patients audio 3 Talking: Press and hold to send an audio message to patient NOTE: When patient privacy is desired, follow the instructions below to place the sticker over the camera and microphone of Receiver/Transponder. The sticker completely blocks the image but may not significantly block the sound. 32 Shutting off the System Use the following procedure to shut down the Display Unit, the Oximeter Box, and the Receiver/Transponder. Display Unit 1. Press and hold the power On/Off button for at least one (1) second.
(A display message will appear.) 2. Choose Power off on the display message to turn off the Display Unit. NOTE: The Display Unit can also be put into sleep mode by pressing the SLEEP button 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 automatically power off when the adaptor is plugged in for charging. NOTE: The Oximeter Box will automatically power off when it detects no finger is in the sensor probe for 3 minutes. Receiver/Transponder Press and hold the power On/Off button for at least three (3) seconds to turn off the Receiver/Transponder. NOTE: When the power is turned off, the power On/Off LED lit green will turn off. 33 Alarms and Limits This chapter describes alarms and limits for Aulisa GA2000 System. Alarms The Display Unit provides high and medium priority audible and visual alarms. High Priority Alarms High priority alarms are 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 color and with alarm text message when alarm limits are met or exceeded. NOTE: Alarm LED indicator on the Oximeter Box will blink red along with displays on the Display Unit. John PR bpm 40 150 50 PULSE RATE LOW 34 Medium Priority Alarms Medium priority alarms are those that signal potential problems with the equipment or 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 Box will blink yellow along with displays on the Display Unit. NOTE: The following table describes alarm conditions and visual indicators. Visual Indicator The Oximeter Box blinks yellow light along with blinking yellow displays and alarm text message on the Display Unit. On the Display Unit, it blinks yellow displays and alarm text message. Alarm Condition
(Medium Priority Alarm) Sensor Probe Detached from Patient Oximeter Box Battery Low Sensor Cable Detached Detection Error Display Unit Battery Low Data Not Updated For 30 seconds Oximeter Box Disconnected Display Unit Wi-Fi Lost Receiver/Transponder Disconnected 35 John O X I M E T E R B O X B AT T E R Y L O W 36 2019-06-03 16:24 John Smith John PR bpm 40 150 50 PULSE RATE LOW O X I M E T E R B O X B AT T E R Y L O W NOTE: The volume for audio alarms cannot be adjusted. Silencing alarms does not mean the situation has been resolved. Tapping on AUDIO 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 single area. Do not plug a headphone into headphone jack of the Display Unit, as this will significantly reduce the volume of alarm audio. Caution!
37 Follow the instructions below to review or set alarm limits. To restore alarm settings to default values, refer to Default Alarm Settings. 1. Ensure the system 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. John NOTE: Alarm limits can be adjusted only when the Oximeter Box has been paired. In an alarm event, ALARM LIMITS button will appear after you select PAUSE AUDIO or AUDIO OFF button. 38 John PR bpm 40 150 50 PULSE RATE LOW 3. To turn alarm limits on or off, 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. RT 2019-06-03 16:24 John 39 4. Tap on + or buttons 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 was previously set at 90%, the min SpO2 limit cannot be set higher 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. NOTE: The following table describes the default settings, adjustment ranges, and intervals. High Priority Alarm Factory Default Adjustment Options Adjustment Interval SpO2 Upper Alarm Limit Off Off, 85 to 100 1% SpO2 SpO2 Lower Alarm Limit 85%
Off, 50 to 95 1% SpO2 Pulse Rate Upper Alarm Limit 150 bpm Off, 75 to 275 1 bpm Pulse Rate Lower Alarm Limit 50 bpm Off, 30 to 110 1 bpm 5. Tap on CONFIRM to save the alarm limits. NOTE: The SpO2 and pulse rate upper and lower alarm limits appear as smaller values to the top right and bottom right of their respective window on the MAIN screen. The new ALARM LIMITS do not go into effect until the CONFIRM button is tapped. A potential hazard exists if different alarm presets are used for the same or similar equipment in any area. 40 When turned 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 alarm. 41 Alarm Delay Function In the traditional alarm management system, upper and lower alarm limits are set so alarms are issued at specific SpO2 levels. When the SpO2 level fluctuates near an alarm limit, each breach will trigger an alarm. Aulisa GA2000 monitors the gradient, the depth and the duration of SpO2 reduction as the factors to determine the alarm riggering delay. Therefore, it helps to distinguish between major clinical events and minor and brief SpO2 alarm limit violations that may trigger an alarm. NOTE: The following table lists the alarm triggering delay statistics for SpO2 Low Alarm Limit. SpO2 Low Alarm Limit Average Delay
(seconds) Maximum Delay
(seconds) 90 86-90 81-85 76-80 75 50 16 6 4 4 74 20 7 6 5 Likewise, when the pulse rate fluctuates near an alarm limit, each breach will trigger an alarm. With the pulse rate alarm delay feature, Aulisa GA2000 allows a period of threshold violation of 7 seconds before an alarm is triggered. Thus, it greatly reduces alarms reported for minor and brief alarm limit violations. NOTE: A countdown timer and AUDIO OFF will be displayed on the MAIN screen when the alarm limit has been breached and the alarm is being delayed. The alarm will be delayed until the timer counts down to zero. 42 Follow the instructions below to restore alarm settings to default values. 1. Ensure there is a system connection established between the Oximeter Box, the Receiver/Transponder and the Display Unit. See System Connection section on page 25 more information.) NOTE: Default alarm settings 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 to restore alarm limits to manufacturer-
configured values. John NOTE: The following table describes the default alarm presets. Alarm Factory Default SpO2 Upper Alarm Limit SpO2 Lower Alarm Limit Pulse Rate Upper Alarm Limit Pulse Rate Lower Alarm Limit Off 85%
150 bpm 50 bpm 43 Powering and Charging Charging the Oximeter Box Charge the Oximeter Box with the charging adaptor (white) by following 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 battery depends on user). 1. Plug the mini-USB end of the cable into the charging port on the Oximeter Box marked by . 44 2. Attach the wall adaptor to a power outlet. NOTE: The power On/Off LED indicator will light blue while charging and turn off when fully charged. NOTE: It takes about 3 hours to fully charge 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: The Oximeter Box cannot be used to measure vital signs while it is being charged. Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. 45 Powering the Display Unit The Display Unit is meant to be used with the charging adaptor (black with a Type-C end) plugged in. If, for some reason, the Display Unit is disconnected from the charging adaptor, proceed with the following steps to charge 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 Unit. 2. Attach the wall adaptor to a power outlet. 3. Place the Display Unit on the stand provided. NOTE: Keep the Display Unit plugged in at all times. Only use adaptors supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. 46 Powering the Receiver/ Transponder The Receiver/Transponder is meant to be used with the charging adaptor (black with micro-USB end) plugged in. 1. Plug the micro-USB cable end of the charging adaptor into Receiver/Transponder. 2. Plug the wall adaptor to a 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 fully charged. NOTE: The battery low LED indicator will light yellow when the battery is low. (See Device Overview section on page 12 for more information.) Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. 47 Care and Maintenance The advanced digital circuitry within the Oximeter Box of this system requires no calibration or periodic maintenance, neither does the Display Unit or the Receiver/Transponder. Field service or repair of this system is not possible. Do not attempt to open the case. Opening the Oximeter Box, the Receiver/Transponder or the Display Unit will damage the device and void the warranty. If the system is not functioning properly, see Troubleshooting section on page 48 for more information. The expected service life of Aulisa GA2000 System is 18 months. Cleaning and Disinfection Clean surface of and disinfect the finger sensor before each use. For surface cleaning and disinfection, follow the recommended actions below. Surface cleaning: Clean the surface of the finger sensor with a soft cloth dampened with rubbing alcohol. Lightly wipe the surface of the device. Disinfection: Use a soft cloth saturated with a solution of 10% chlorine bleach in tap water, lightly wiping the surface of the device. Do not pour or spray any liquids onto components, and do not allow any liquids 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. 48 Troubleshooting Problem Possible Solution Cannot turn on the Oximeter Box Cannot turn on the Display Unit Click the power On/Off button. Fully charge the Oximeter Box until the blue LED goes off. Press and hold the power On/Off button for at least three (3) seconds. Make sure the power cord is properly connected to the outlet and the Display Unit. Cannot turn on the Receiver/Transponder Make sure the power cord is properly Press and hold the power On/Off button for three (3) seconds. connected to the outlet and the Receiver/
Transponder. Unable to obtain a valid SpO2 or pulse rate reading NOTE: In some instances, patient perfusion may be inadequate for pulse detection. 49 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. Allow the hand to rest comfortably without squeezing or pressing the sensor probe on a hard surface. Problem Possible Solution Unable to obtain a valid SpO2 or pulse rate reading. NOTE: In some instances, patient perfusion may be inadequate for pulse detection. Unstable/Constant SpO2 and Pulse Rate readings Make sure the system connection is established. Reduce or eliminate any interference. Make sure that the finger sensor is not placed on the same wrist being used for other patient therapies or diagnostics
(e.g. blood pressure cuff). Make 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 Oximeter Box for power. Ensure that the Oximeter Box is within 10 meters spherical radius to the Receiver/Transponder. Check the sensor cable for any visible signs of deterioration. Shield the finger sensor from the light source. Insert the sensor probe to a finger without artificial or polished nails. Position the sensor probe at a different site. 50 Problem Possible Solution Make sure the sensor probe is attached to the finger securely. Make sure the sensor cable is securely attached to the Oximeter Box. Check the sensor cable for any visible signs of deterioration. Reduce patient motion. Make sure the sensor cable is securely attached to the Oximeter Box. Make sure the sensor probe is attached to the finger securely. Ensure that the Oximeter Box is within 10 meters spherical radius to the Receiver/Transponder. Relocate the sensor at a different site. Turn off the 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. Relocate the sensor probe at a different site. Insert the sensor probe to a finger without fingernail polish or an artificial nail. Unstable/Constant SpO2 and Pulse Rate readings A dash --- appears in the vital sign display. Data has not been updated for 30 seconds. 51 Problem Possible Solution The unit is in Alarm mode, but no audible alarms can be heard. Cannot establish system connection Wait for two minutes and alarm tones will automatically re-engage if it was silenced temporarily. Make sure there are no headphones inserted into the headphone jack of the Display Unit. Ensure that the Oximeter Box is within 10 meters spherical radius to Receiver/
Transponder while being paired. Check network usage/bandwith of other interfaces within the Wi-Fi network that may prevent the system from establishing a connection. Turn off the system, verify system connections, and retry. Reset the Wi-Fi network for the Display Unit. Reset the Wi-Fi network for the Receiver/Transponder. If these solutions do not correct the problem, please contact your www.aulisa.com distributor, or contact Aulisa by going online at under Contact Us. This system is a precision electronic instrument andmust be repaired by knowledgeable and specially trained Aulisa personnel only. Do not attempt to open the case or repair the electronics. 52 Device Performance SpO2 Accuracy SpO2 accuracy testing is performed by in vivo accuracy testing under laboratory conditions on healthy adult subjects with varying skin pigmentation in an independent research laboratory through induced hypoxia studies. Analysis of bias1 was performed vs. Hemoximeter data. The limits of agreement shown 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 error (RMS error) is calculated as follows:
RMS Error =
(SpO -SaO ) 2 2 n 2 1Bias is defined as the monitor under test reading minus the hemoximeter reading. Note:Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of Aulisa GA2000 Digital Vital Sign Monitoring System measurements can be expected to fall within Arms of the value measured by a co-oximeter. Arms from the Clinical Study Accuracy
(Arms) 90%-100%
80%-90%
70%-80%
53 1.39 1.77 2.08 The graph below shows the error (SpO2-SaO2) plots of each subject measured by the Aulisa GA2000 with upper and lower 95% limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers. 2 2 2 Pulse Rate Accuracy Pulse rate 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, and SpO2 settings of 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, and 1%. All 880 combinations of testing points
(=8 x 10 x 11) of Pulse Rate passed the 3% acceptance criteria. Equipment Response Time Aulisa GA2000 Digital Vital Sign Monitoring System uses a moving average to determine the Pulse Rate and SpO2. The following table shows the equipment response time of Aulisa GA2000 Digital Vital Sign Monitoring System. Equipment Data Averaging Alarm Condition Delay Alarm Signal Generation Delay Data Update Period Delay (Seconds) 4 seconds 4 seconds 0 seconds 1 second 54 Manufacturer's Declaration Refer to the following table for specific information regarding compliance to IEC 60601-1-2 for this device. Guidance and Manufacturer's Declaration - Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS Guidance and Manufacturer's Declaration-
Electromagnetic Emission This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Emissions test Compliance RF emissions CISPR 11 Group 1 Electromagnetic environment -guidance This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker Emissions IEC 61000-3-3 Class B Complies Complies This device is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 55 Guidance and Manufacturer's Declaration-Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS Guidance and Manufacturer's Declaration-
Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment-
guidance Electrostatic Discharge
(ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, relative humidity should be at least 30%. Electrical Fast Transient/
Burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 1 kV differential mode 2 kV commom mode 1 kV differential mode 2 kV commom mode Mains power quality should be that of a typical commercial or hospital environment. 56 Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment-
guidance Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 Power Frequency
(50/60 Hz) Magnetic Field 30 A/m 30 A/m IEC 61000-4-8 Mains power quality should be that of a typical commercial or hospital environment. Power frequency magnetic fields should be at levels 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. 57 Guidance and Manufacturer's Declaration-Electromagnetic Immunity-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and Manufacturer's Declaration-
Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Immunity test IEC 60601-1-2 test level Compliance level Conducted RF IEC 61000-4-6 3 V/m 150 kHz to 80 MHz Conducted RF IEC 61000-4-3 3 V/m 10 V/m Electromagnetic environment-
guidance Recommended Separation Distance 58 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones 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 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 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/m. 59 FCC Compliance For Oximeter Box Declaration of Conformity with FCC for Electromagnetic Compatibility This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Federal Communications Commission (FCC) Notice This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on. The user is encouraged 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) 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 radio/TV technician for help. The device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the U.S. Government. These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population. The guidelines are based on the safety standards previously set by both U.S. and international standards bodies. This equipment has been shown to be capable of compliance for localized specific absorption rate (SAR) for uncontrolled environment/ general population exposure limits specified in ANSI/IEEE Std. C95.1-1992 and has been tested in accordance with the measurement procedures specified in IEEE Std. 1528-200X (Draft 6.5, January 2002). RF Exposure: For body worn operation, to maintain compliance with FCC RF exposure guidelines, use only accessories that contain non- metallic components. RF exposure separation distance is 5 mm. Use of other accessories may violate FCC RF exposure guidelines and should be avoided. 60 The FCC requires the user to be notified that any changes or 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. For Display Unit & Receiver/Transponder Declaration of Conformity with FCC for Electromagnetic Compatibility This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired 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 limits are designed to provide reasonable protection against harmful interference when the equipment is 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 interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. FCC Radiation Exposure Statement For Display Unit This equipment is compliance with SAR for general population/uncontrolled exposure limits in ANSI/IEEE C95.1-1999 and had been tested in accordance with the measurement methods and procedures specified in OET Bulletin 65 Supplement C. The highest reported SAR for the device is 0.116 W/kg. For Receiver/Transponder This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 61 When suing IEEE 802.11a wireless LAN, this product is restricted to indoor use, due to its operation in the 5.15 to 5.25GHz frequency range. The FCC requires 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 as the primary user of the 5.25 to 5.35GHz and 5.65 to 5.85GHz bands. These radar stations can cause interference with and/or damage to this device. No modifications to this device are allowed that in any way affect or alter its antenna or antenna configuration. 62 Service, Support, and Warranty Warranty under Contact Us. 63 Device Privacy Policy This Privacy Policy was last updated on March 22, 2019. Our Policy This privacy policy applies to personal information collected by Taiwan Aulisa Medical Devices Technologies, Inc. (Aulisa, we, us and/or our) from users of the Aulisa remote patient monitoring devices
(the Devices). Personal Information includes any information that can be used on its own or with other information to identify or contact a single person or to identify an individual in context. If we can link particular information (directly or indirectly) to an individual, we will consider this information 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 VITALS IN ORDER TO AID PATIENTS, HEALTHCARE PROVIDERS
(PROVIDERS), AND CAREGIVERS MAKE INFORMED DECISIONS ABOUT YOUR CARE. THE PERSONAL INFORMATION WE COLLECT AND TRANSMIT MAY INCLUDE HEALTHCARE INFORMATION, INCLUDING MEDICAL INFORMATION. THEREFORE, OUR PRIVACY PRACTICES ARE INTENDED TO COMPLY WITH THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPPA). WE WILL MAINTAIN THE PRIVACY OF YOUR HEALTH INFORMATION AS REQUIRED BY HIPPA AND THE REGULATIONS PROMULGATED UNDER THAT ACT. FOR ADDITIONAL INFORMATION RELATED TO YOUR HEALTHCARE INFORMATION, PLEASE CONTACT information@aulisa.com
. 64 65
(7) protect our rights, privacy, safety or property, and/or that of yours or others; and (8) allow us to pursue available remedies or limit the damages we may sustain. Failure to Provide Information Providing your Personal Information is not statutorily or contractually mandated. If you choose not to provide this information, we cannot monitor your vital signs, and you will be unable to use our Devices. Support Information If you contact Aulisa for support or to lodge a complaint, we may collect technical 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 Policy. Calls with Aulisa may be recorded or monitored for training, quality assurance, customer service, and reference purposes. Aggregated Personal Data: In an ongoing eort to better understand and serve our customers, other users of the Devices, and communities of patients with similar health conditions, Aulisa may conduct research on 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 Aulisa may share this research and related information in aggregated, de-identied and/or anonymized format with its aliates, agents and other healthcare research and services entities, including without limitation insurance and pharmaceutical companies. For the avoidance of doubt, this aggregate information does not identify you personally. Aulisa may also disclose aggregated, de-identied and/or anonymized information in order to describe our business and the Devices to current and prospective business partners and Customers, and to other third parties for other lawful purposes. Where Is My Personal Information Stored And/Or Processed?
Information Aulisa collects through the Devices will be processed and/
or stored on secure third- party cloud-based servers or through a Wi-Fi network. All of the information you share with us through the Devices is double-encrypted during transmission using AES-128 data encryption as well as an Aulisa private encryption method. Will You Share My Personal Information with Anyone Else?
66 We consider your information to be a vital part of our relationship with you. There are, however, certain circumstances in which we may share your Personal Information with certain third parties without further notice to you. Those circumstances are described below:
With Our Provider Customers: If you are a Patient, we will share your Personal Information and Health Data with our Provider Customer(s) that provide healthcare services to you. This will enable your Provider to track your Health Data and combine such Health Data with other information about you that your Provider obtains in providing healthcare services to you. With Caregivers: If you are a Patient, family and/or friends may view certain of your Personal Information and/or Health Data and related alerts. In the Event of a Business Transfer: We might sell or buy businesses or assets. In the event of a corporate sale, merger, reorganization, dissolution or similar event, Personal Information may be part of the transferred assets. With Related Companies: We may also share Personal Information with 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 certain business-related functions. Examples of such functions include data hosting and billing management. When we employ another entity to perform a function of this nature, we only provide the entity with the information that it needs to perform its specic function. To Meet Our Legal Requirements: We may disclose your Personal Information if required to do so by law or if we have a good faith belief that such action is necessary to (i) comply with a legal obligation,
(ii) protect and defend our rights or property, (iii) act in urgent circumstances to protect the personal safety of you, us, other users of the Devices or the public, or (iv) protect against legal liability. NOTE: We may, from time to time, rent or sell aggregated data and/or other information that does not 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 research institutions to learn more about symptoms associated with your medical condition(s). 67 How Long Will You Retain the Information?
We only store certain of your Personal Information for as long as you use the Devices and up to five (5) years after you cease to use the Devices. At the end of this five-year period, we will remove your Personal Information from our databases and will request that our business partners remove your Personal Information from their databases. However, once we disclose your Personal Information to third parties, we may not be able to access that Personal Information any longer and cannot force the deletion or modification of any such information by the parties to whom we have made those disclosures. Written requests for deletion of Personal Information other than as described should be directed to
. We retain anonymized data indefinitely. information@aulisa.com How Do You Protect My Personal Information?
Aulisa is committed to protecting the security and condentiality of Personal Information. We use a combination of reasonable 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 security or integrity of such information, and to protect against unauthorized access to or use of such information in our possession or control that could result in substantial harm or inconvenience to you. However, Internet data transmissions, whether wired or wireless, cannot be guaranteed to be 100% secure. As a result, we cannot guarantee the security of information you transmit to us. By using the Devices, you are assuming this risk. Safeguards 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, backups, and access controls. If Aulisa learns of a security concern, we may attempt to notify you and provide information on protective steps, if available, through the email address that you have provided to us or other reasonable notication. Depending on where you live, you may have a legal right to receive such notices in writing. 68 information@aulisa.com. 69 Where our processing of your Personal Information is based on consent, you have the right to withdraw that consent without detriment at any time by contacting us at exercise the rights listed above at any time by contacting us at information@aulisa.com information@aulisa.com
. You can also
. How Can I Update, Correct or Delete My Personal Information?
If you need to make changes or corrections to your information, you may make such changes or corrections 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 terms of this Privacy Policy, you have the legal authority to accept this Privacy Policy on behalf of such minor as the minor's parent or legal guardian. If you do not have such legal authority, do NOT accept this Privacy Policy and do not use the Devices on behalf of such minor. How Can I Contact Aulisa?
If you have any questions or comments about this Privacy Policy, our practices, or our Devices, please feel free to e-mail us at information@aulisa.com
. 70 Specifications Aulisa GA2000 Digital Vital Sign Monitoring System Blood Oxygen Saturation Display Range (SpO )2 Pulse Rate Display Range Accuracy Blood Oxygen Saturation
(%SpO ) ( 1 S.D.) 70-100% 3 digits 30 to 290 bpm 1% to 100%
2 Pulse Rate 3%
Alarms SpO2 Default SpO2 Limit Upper Limit Lower Limit Off 85%
Alarm Limit Range Upper Limit 85-100%
Lower Limit 50-95%
Adjustment Step 1% SpO2 Pulse Rate Default Pulse Rate Limit Upper Limit 150 bpm Lower Limit 50 bpm Alarm Limit Range Upper Limit Lower Limit 75-275 bpm 30-110 bpm Adjustment Step 1 bpm 71 Measurement Wavelengths and Output Power Red Infrared 660 nanometers @ 1.8 mw nominal 905 nanometers @ 2 mw nominal Bluetooth Communication Range Protocol Direction Data rate Protocol Direction Wi-Fi Communication 10-meter spherical radius Bluetooth 4.0 Bi-direction Up to 100kBps 802.11 b/g/n/ac, 2.4GHz/5GHz Bi-direction Temperature Operating Storage/Transportation
+ 5C to + 40C 25C to+ 70C Operating Altitude Atmospheric Pressure Humidity Operating Storage/Transportation altitude 3000 m 700 hPa to 1013 hPa 15% to 90%, non-condensing 10% to 93% relative humidity, non-condensing Classifications per IEC/ EN 60601-1 Type of Protection Degree of Protection Mode of Operation Class II, MOPP (on AC power) Internally powered
(on battery power) Type BF-Applied Part Continuous 72 Oximeter Box Internal Power Battery Operating Life Dimensions Without sensors Weight 3.7 V battery 22 hours of continuous operation 0.7 x 1.3 x 2.7 16 mm x 32 mm x 68 mm 1 oz 28 g Wireless Communication Bluetooth Ingress Protection IP22 Display Unit Display Display panel Power Requirements Mains DC Input Internal Power Battery Operating Life Dimensions Weight Wireless Communication Alarm Sound Pressure Ingress Protection Receiver/Transponder Power Requirements Mains DC Input Internal Power Battery Operating Life 10.1 IPS Touch Panel 100-240 V AC 50-60 Hz 5 V DC/AC adaptor 3.8 V battery 2 hours of continuous operation 7.04 x 10.35 x 0.46 179 mm x 263 mm x 11.8 mm 21.87 oz 620 g Wi-Fi 60 dB IP22 100-240 V AC 50-60 Hz 5 V DC/AC adaptor 3.7 V battery 2 hours of continuous operation 73 Dimensions 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 74 Parts and Accessories Oximeter Box Adult Oximeter Sensor Cable Pediatric Oximeter Sensor Cable Wristband Receiver/Transponder Display Unit Stand- Display Unit Charging Adaptor-Oximeter Box Charging Adaptor-Display Unit Charging Adaptor-Receiver/Transponder Model Number GA-SM0001 GA-RS0002 GA-RS0004 GA-WB0002 GA-RT0001 GA-DU0003 GA-SD0002 GA-CS0001 GA-CD0004 GA-CR0001 For more information about Aulisa parts and accessories, contact your distributor, or contact Aulisa by going online at www.aulisa.com under Contact Us. Using accessories not by Taiwan Aulisa Medical Devices Technologies, Inc. may result in inaccurate measurements. Always use parts and accessories by Taiwan Aulisa Medical Devices Technologies, Inc. 75
1 2 | ID Label and Location | ID Label/Location Info | 75.51 KiB | February 03 2020 |
FCC ID LABEL FORMAT AND LOCATION Applicant: Taiwan Aulisa Medical Devices Technologies Inc FCC ID:
2AI5QGA-RT0001
1 2 | Confidentiality Request Letter | Cover Letter(s) | 194.94 KiB | February 03 2020 |
DATE: 2019/06/11 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AISQGA-RT0001 Request for Confidentialit Pursuant to Sections 0.457 and 0.459 of the commissions rules, we hereby request that the following documents be held confidential:
(List here the documents for which you are seeking confidentiality for example ...) e Schematics e Block diagram e Operation description These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Name/Title: Augustine Lien/CEO Company Name: Taiwan Aulisa Medical Devices Technologies, Inc Address: 10F, No.32, YuanQu St., Nangang Dist., 11503 Taipei City, Taiwan TEL: +886-2-26557297 FAX: +886-2-26557260 Email: Augustine. Lien@aulisa.com
frequency | equipment class | purpose | ||
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1 | 2020-02-03 | 5745 ~ 5825 | NII - Unlicensed National Information Infrastructure TX | Original Equipment |
2 | 2020-02-02 | 2412 ~ 2462 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
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1 2 | Effective |
2020-02-03
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1 2 |
2020-02-02
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1 2 | Applicant's complete, legal business name |
Taiwan Aulisa Medical Devices Technologies, Inc.
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1 2 | FCC Registration Number (FRN) |
0025735697
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1 2 | Physical Address |
10F., No.3-2, YuanQu St., Nangang Dist.
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1 2 |
Taipei City, N/A
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1 2 |
Taipei City, N/A 11503
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1 2 |
Taiwan
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
s******@nemko.com
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1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 2 | Grantee Code |
2AI5Q
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1 2 | Equipment Product Code |
GA-RT0001
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
A******** L********
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1 2 | Telephone Number |
+886-********
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1 2 | Fax Number |
+886-********
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1 2 |
A******@aulisa.com
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app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | NII - Unlicensed National Information Infrastructure TX | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Receiver/Transponder | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output power listed is conducted. This device has 20 MHz, 40 MHz and 80MHz bandwidth modes. The RF exposure compliance is addressed for 1.1310 and 2.1091 MPE limits - this filing complies with KDB 447498 and is approved for mobile/fixed operation. End Users must be provided with transmitter operation conditions for satisfying RF exposure compliance. | ||||
1 2 | Output power listed is conducted. This device has 20 MHz and 40MHz bandwidth modes. The RF exposure compliance is addressed for 1.1310 and 2.1091 MPE limits - this filing complies with KDB 447498 and is approved for mobile/fixed operation. End Users must be provided with transmitter operation conditions for satisfying RF exposure compliance. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
International Standards Laboratory LT lab.
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1 2 | Name |
B****** C******
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1 2 | Telephone Number |
886-3******** Extension:
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1 2 | Fax Number |
886-3********
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1 2 |
b******@isl.com.tw
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15E | CC | 5180 | 5240 | 0.0155 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15E | CC ND | 5260 | 5320 | 0.0143 | |||||||||||||||||||||||||||||||||||
1 | 3 | 15E | CC ND | 5500 | 5700 | 0.0233 | |||||||||||||||||||||||||||||||||||
1 | 4 | 15E | CC | 5745 | 5825 | 0.0217 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2402 | 2480 | 0.0002 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15C | CC | 2412 | 2462 | 0.0478 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
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