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1 | Users Manual | Users Manual | 1.53 MiB | October 06 2019 / November 06 2019 |
Aulisa Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System Instructions For Use Version: 1.0 CAUTION! Read this entire manual carefully before using Aulisa GA1001 Digital Vital Sign Monitoring System. 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. Taiwan Aulisa Medical Devices Technologies, Inc. No. 218-2, Chong Yang Rd. Nangang Dist, Taipei Taiwan Tel +886-2-2655-7297 www.aulisa.com 2018 Taiwan Aulisa Medical Devices Technologies, Inc. Table of Contents GUIDE TO SYMBOLS............................................................................................................. 1 PRECAUTIONS FOR USE ..................................................................................................... 3 USING AULISA GA1001 DIGITAL VITAL SIGN MONITORING SYSTEM ....................... 5 INTENDED USE ............................................................................................................................. 6 PRINCIPLE OF OPERATION .......................................................................................................... 6 SYSTEM OVERVIEW ..................................................................................................................... 6 DEVICE OVERVIEW ...................................................................................................................... 7 DISPLAYS, INDICATORS, AND CONTROLS ................................................................................... 8 SETTING UP AULISA GA1001 SYSTEM .................................................................................... 13 DEVICE PAIRING ........................................................................................................................ 16 VERIFYING SYSTEM OPERATION ............................................................................................... 17 SHUTTING OFF THE SYSTEM ...................................................................................................... 18 ALARMS AND LIMITS .......................................................................................................... 19 ALARMS ..................................................................................................................................... 19 ADJUSTING ALARM LIMITS ........................................................................................................ 23 DEFAULT ALARM SETTINGS ...................................................................................................... 26 POWERING AND CHARGING ............................................................................................. 27 POWERING THE DISPLAY UNIT .................................................................................................. 27 CHARGING THE INFANT OXIMETER MODULE ............................................................................ 28 CARE AND MAINTENANCE ................................................................................................ 30 CLEANING .................................................................................................................................. 30 TROUBLESHOOTING .......................................................................................................... 31 TECHNICAL INFORMATION ............................................................................................... 33 DEVICE PERFORMANCE ............................................................................................................. 33 MANUFACTURES DECLARATION .............................................................................................. 35 FCC COMPLIANCE .................................................................................................................... 38 SERVICE, SUPPORT, AND WARRANTY .......................................................................... 39 SPECIFICATIONS ................................................................................................................. 41 PARTS AND ACCESSORIES .............................................................................................. 43 Guide to Symbols Symbol Description Refer to instruction manual Type BF-Applied Part (patient isolation from electrical shock) Indicates separate collection for electrical and electronic equipment
(WEEE). Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur in the vicinity of equipment marked with this symbol. Manufacturer Serial number Lot number Federal law (USA) restricts this device to sale by or on the order of a licensed health care professional only. Temperature limit 1 IP22 Non-sterile Classification for water ingress and particulate matter 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. This system is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. 2. A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor. Pulse oximeters do not require calibration. 3. Oximeter readings may be affected by the use of an electrosurgical unit. 4. As with all medical equipment, carefully route all cables to reduce the possibility of entanglement, strangulation or injury to the patient. 5. Be careful with small parts that can be removed from the device and swallowed, such as port covers. They are hazardous to children. 6. Excessive pressure to the sensor application site for prolonged periods may cause damage to the skin beneath the sensor. 7. Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor. 8. Do not use in or around water or any other liquid when AC power adaptor is used. 9. Only use Aulisa GA1001 Digital Vital Sign Monitoring System with Charging Adaptors provided by Aulisa. 10. Aulisa GA1001 Digital Vital Sign Monitoring System is designed to determine functional oxygen saturation, the percentage of arterial oxygen saturation of functional hemoglobin (SpO2). Significant levels of dysfunctional hemoglobin, such as methemoglobin, might affect the accuracy of the measurement. 11. Anemia may affect the accuracy of the measurement. 12. Use Aulisa GA1001 Digital Vital Sign Monitoring System only when the components are installed within the specified distances from the monitored patient approximately 10 meters (32.8 feet) spherical radius from the Infant Oximeter Module to the Display Unit. Moving outside this range may cause missing, lost, and/or inaccurate data. 13. 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. 14. This product is not a substitution for physician supervision. 15. Always refer to Instructions For Use for full warnings and instructions. 3 16. Failure to follow instructions and warnings may result in serious injury or death. Cautions 1. This equipment complies with International Standard EN 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, homecare 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 GA1001 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 might not work on cold extremities due to reduced circulation. Warm or rub the foot to increase circulation or reposition the sensor. 6. Aulisa GA1001 Digital Vital Sign Monitoring 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. Inspect and relocate the sensor application site at least every 10 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary due to medical status or skin condition. 9. Do not place liquids on top of the device. 10. Do not immerse the device or any of the components in any liquids. 11. Do not use caustic or abrasive cleaning agents on the device. 12. Do not gas sterilize or autoclave this pulse oximetry system. 13. Batteries might leak or explode if used or disposed of improperly. 14. Follow local governing ordinances and recycling instructions regarding 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 Infant Oximeter Module too tightly around the patients foot. Inaccurate readings and patient discomfort could result. 4 Using Aulisa GA1001 Digital Vital Sign Monitoring System This chapter describes how to use Aulisa GA1001 Digital Vital Sign Monitoring System (hereinafter referred to as Aulisa GA1001 system). The system includes the following components and accessories:
Infant Oximeter Module Wireless Charging Case- Infant Oximeter Module Display Unit Stand- Display Unit Charging Adaptor- Wireless Charging Case Charging Adaptor- Display Unit 5
(White)
(Black) Adhesive Patch- Infant Oximeter Module Intended Use The Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-
checking and/or continuous monitoring of pediatrics and infants during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. Principle of Operation Aulisa GA1001 Digital Vital Sign Monitoring System measures SpO2 and pulse rate based on non-invasive light-emitting diode (LED) reflectance 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 6 Device Overview Display Unit The Display Unit features a 10.1 HD LCD multi- touch display with Bluetooth technology. The Display Unit displays real-time vital signs measured by the Infant Oximeter Module. The Display Unit will display informational text messages, alarm text messages, and beep audibly upon an alarm condition trigger event. NOTE:
It is recommended that the Display Unit be placed on the stand provided. NOTE: Only use fingers or the stylus pen provided to operate keys on the touch screen. NOTE: Close the cover of charging port when the charging adaptor is not in use. 7 Infant Oximeter Module The Infant Oximeter Module includes a Bluetooth transmitter and a sensor, which is worn by the patient for vital sign monitoring. It features sensors and electronics for vital sign measuring and analyzing. The Infant Oximeter Module must be used within 10 meters (32.8 feet) from the Display Unit. Displays, Indicators, and Controls This section describes the displays, indicators, and controls for Aulisa GA1001 System. Display Icons and Indicators Blood Oxygen This icon identifies the window showing the functional blood oxygen saturation in percent. Pulse Rate This icon identifies the window showing the pulse rate in bpm. Pulse Amplitude This icon identifies the window showing the pulse amplitude. 8
?
No data When the vital signs cannot be measured, the Display Unit shows dashes (- - -) in each of the vital sign windows. Inadequate data When the vital sign values are inadequate, the Display Unit shows (?) beside the value. Bluetooth Connection Status This icon displays whether the Infant Oximeter Module and the Display Unit are connected via Bluetooth. It will turn blue once the Infant Oximeter Module is paired with Display Unit. Measurement Site Status This icon displays whether the sensor is attached to the patients foot. A system alarm will be displayed on the Display Unit if no contact is detected between the sensor and the patients foot. Motion Indicator This animated icon detects excessive motion of the measurement site. Battery Level of the Infant Oximeter Module 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 Infant Oximeter Module battery is low. Battery Level of Display Unit 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. 9 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. Software Control Buttons Create Patient Profile Tap on this button on the MAIN screen to add a patient profile, including name, weight, gender, date of birth, and location. Edit Profile This button replaces ADD PROFILE button when a patient profile already exits. Tap on the button to edit the existing patient profile. Set Alarm Limits Tap on this button on the MAIN screen to adjust the alarm limits for each vital sign. (See Alarm and Limits section on page 19 for more information on adjusting the alarm limits.) NOTE: The button is operable only when wireless connection is established. 10 Device Pairing This button appears on the top right corner of the MAIN screen when the system is disconnected. Tap on the button to force the system to pair. NOTE: The Infant Oximeter Module must be placed within 10 meters (32.8 feet) from the Display Unit. System Settings 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 MAIN screen to return to the previous page. Set Timezone In the settings menu, tap on this button to set the local time and date. Sleep Mode Tap on this button on the top left corner of the MAIN screen to let the Display Unit enter sleep mode. To wake up the Display Unit, tap on the blank screen and use finger to swipe to the right. Set Display Brightness In the settings menu, tap on this button to set the brightness of the display. 11 Restore Default Alarm In the settings menu, tap on this button to restore alarm limits to manufacture-configured values. Scan QR Code In the settings menu, tap on this button and scan the barcode on the back of the Infant Oximeter Module to manually pair the desired Infant Oximeter Module to the Display Unit. (See Device Pairing on page 16 for more information.) Choose Theme In the settings menu, tap on this button to choose the desired theme. Infant Oximeter Module Tutorial In the settings menu, tap on this button to open the Infant Oximeter Module Tutorial. Pause 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 triggering alarm event for 2 minutes. Turn Off Alarm Audio 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 triggering alarm event. 12 Setting up Aulisa GA1001 System Use the following procedure to set up the Aulisa GA1001 System:
It is recommended to charge the Infant Oximeter Module fully prior to setting up Aulisa GA1001 System as it takes around 3 hours to fully charge. (See Powering and Charging section on page 27 for more information.) 1. Turn on the Infant Oximeter Module by removing it from the wireless charging case. NOTE: The Infant Oximeter Module will turn itself on automatically when The wireless charging case is opened. NOTE: The power LED will light green when the power is ON. 2. Connect the GA-CD0002 Charging Adaptor- Display Unit to the Display Unit and a power outlet. 3. Press and hold the power On/Off button for at least three (3) seconds to turn on the Display Unit. CAUTION! For long term monitoring (over 3 hours of continuous use), the Display Unit must be connected to the charging adaptor. CAUTION! Do not plug adaptor into a switched outlet to prevent accidental switching power off. 4. Select the correct timezone. The MAIN screen will show up after completion. 5. Wait for the wireless connection between the Infant Oximeter Module and the Display Unit to be established. (See Device Pairing section on page 16 for more information.) NOTE: The Bluetooth connection status icon will turn blue once the Infant Oximeter Module is paired with the Display Unit. 6. Verify System Operation. (See Verifying System Operation section on page 17 for more information.) 7. Attach the adhesive patch onto the back of the Infant Oximeter Module following the instructions below. 13 a. Remove the top paper liner of the adhesive patch b. Attach the top of the adhesive patch onto the back of the Infant Oximeter Module IMPORTANT! The clear window on the Infant Oximeter Module Adhesive Patch must align with the sensor probe of the Infant Oximeter Module. Remove the bottom paper liner of the adhesive patch c. Attach the bottom of the adhesive patch onto the back of the Infant Oximeter Module, pressing down to smooth out the surface so no air bubbles remain d. Remove the plastic liner of the adhesive patch NOTE:
Infant Oximeter Module Adhesive Patches are disposable and for single use only. 8. Attach the Infant Oximeter Module (SM) to the patients foot following the instructions below. 14 a. Align the sensor probe on the center of the babys foot. b. Press and hold the end of the strap until it has adhered to the skin. c. Gently wrap the strap around the babys foot. d. Slightly fasten the strap. e. Stick the Velcro ends together. f. All done! Ready to use. NOTE: The LED indicator will blink green when valid vital sign data is detected. CAUTION! Do not wrap the Infant Oximeter Module around the foot too tightly as it may affect blood circulation. CAUTION! Do not twist, bend or pull the end of the strap with the sensor probe. CAUTION!
Inspect and relocate the sensor application site at least every 10 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors may vary due to medical status or skin condition. 15 Device Pairing The Display Unit will automatically scan and connect to the Infant Oximeter Module from the same starter kit. If the connection is not established automatically, press PAIR button on the MAIN screen of the Display Unit to force the system to pair. NOTE: The Bluetooth connection status icon will turn blue once the Display Unit is paired with the Infant Oximeter Module. NOTE: The Infant Oximeter Module must be placed within 10 meters
(32.8 feet) from the Display Unit. Use the following procedure to switch among Infant Oximeter Modules and establish a connection between the Display Unit and the desired Infant Oximeter Module. 1. Ensure the desired Infant Oximeter Module is turned on. NOTE: The desired Infant Oximeter Module must be placed within 10 meters (32.8 feet) from the Display Unit. NOTE: The power LED lights green when the power is ON. 2. In the settings menu, select Sensor Pairing. 3. Scan the QR Code located on the back of the desired Infant Oximeter Module. 4. Press CONFIRM if the serial number (SN) displayed matches with the SN on the back of the desired Infant Oximeter Module. 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: After the Display Unit is paired to a Infant Oximeter Module, it will remain paired until the above process is repeated. 16 Verifying System Operation Use the following procedure to verify that the alarm system is working properly. 1. Ensure the Infant Oximeter Module and Display Unit are both turned on. 2. Ensure there is a connection established between the Infant Oximeter Module and Display Unit. (See Device Pairing section on page 16 for more information.) 3. Place the Infant Oximeter Module on a flat surface. 4. Verify that an alarm message is displayed and that an alarm audio is generated. (See Troubleshooting section on page 31 if an alarm message and audio signal is not generated.) 5. Press on the PAUSE AUDIO to temporarily silence for 2 minutes. 6. After the alarm signal is regenerated, press on the AUDIO OFF to silence permanently the alarm signal. NOTE: Alarm systems should be checked before use. Use the procedure below to monitor the readings (SpO2, pulse rate, pulse amplitude) to verify that the device is functioning properly. 1. Set up Aulisa GA1001 system according to instructions above. (See Setting up Aulisa GA1001 system section on page 13 for more information.) 2. Ensure the Infant Oximeter Module is securely attached to the foot. 3. Verify the status indicator on the Infant Oximeter Module is blinking green and that the Bluetooth connection status icon on the Display Unit is blue. 4. Verify that a SpO2 reading is displayed, that a pulse rate value appears, and that a PA reading is displayed. 17 Shutting off the System Use the procedure below to shut down the Display Unit and the Infant Oximeter Module. Display Unit 1. Press 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 to sleep by pressing the SLEEP button on the top left corner of the MAIN screen. Infant Oximeter Module Placing the Infant Oximeter Module inside the wireless charging case and closing the cover will automatically turn the power off. NOTE: When the power is turned off, the power LED lit green will turn off. NOTE: The Infant Oximeter Module is automatically activated when the wireless charging case is opened. NOTE: Charge the Infant Oximeter Module when it is not in use. 18 Alarms and Limits This chapter describes alarms and limits for Aulisa GA1001 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 Infant Oximeter Module will blink red along with displays on the Display Unit. High priority audio alarms are: 3 beeps, short pause, 2 beeps, short pause, 3 beeps, short pause, 2 beeps, and 5-second pause. This sequence repeats until the alarm is cleared or silenced. Tap on PAUSE AUDIO button to pause the alarm audio for 2 minutes. Tap on AUDIO OFF button to permanently silence the alarm audio. Alarm limits may be adjusted by pressing ALARM LIMITS button after silencing the alarms. (See Adjusting Alarm Limits section on page 23 for more information.) 19 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 Infant Oximeter Module will blink red along with displays on the Display Unit. The following table describes alarm conditions and visual indicators. Alarm Condition
(Medium Priority Alarm) Sensor Probe Detached from Patient Infant Oximeter Module Battery Low Data Update Period Exceeds Limit (More Than 25 Seconds) Display Unit Battery Low Bluetooth Disconnected BLE Connection Lost. Reconnecting Visual Indicator The Infant Oximeter Module 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. 20 Medium priority audio alarms are: 3 beeps and 25-second pause. This sequence repeats until the alarm is cleared or silenced. Tap on PAUSE AUDIO button to pause the alarm audio for 2 minutes. Tap on 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 23 for more information.) Multiple Alarms When there are high and medium priority alarms triggered simultaneously, the system will display all the alarm text messages but will only sound the high priority alarm. NOTE: The volume for audio alarms cannot be adjusted. WARNING! Silencing alarms does not mean the situation has been resolved. WARNING! Tapping on AUDIO OFF will permanently silence the alarm audio of the current triggering alarm event. WARNING! A potential hazard exists if different alarm presets are used for the same or similar equipment in any single area. 21 CAUTION!
Do not plug a headphone into the headphone jack of the Display Unit, as this will significantly reduce the volume of alarm audio. 22 Adjusting Alarm Limits Follow the instructions below to review or set alarm limits. To restore alarm settings to default values, refer to Default Alarm Settings section on page 26 for more information. 1. Ensure there is a connection established between the Display Unit and the Infant Oximeter Module. (See Device Pairing section on page 16 for more information.) 2. Tap on ALARM LIMITS button on the MAIN screen. In an alarm event, ALARM LIMITS button will appear after you select PAUSE AUDIO or AUDIO OFF. NOTE: Alarm limits can be adjusted only when the Display Unit is connected to the Infant Oximeter Module. 23 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 PA (pulse amplitude). 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 high than 90%. If you want to set min SpO2 limit at 90%, turn on the max SpO2 limit, set it above 90% and turn it off again as you wish. NOTE: The following table describes the default settings, adjustment ranges, and intervals. High Priority Alarm Factory Default Adjustment Adjustment Options 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 200 bpm Off, 75 to 275 1 bpm Pulse Rate Lower Alarm Limit 75 bpm Off, 30 to 110 1 bpm 5. Tap on CONFIRM to save the alarm limits. 24 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. WARNING! The new ALARM LIMITS do not go into effect until the CONFIRM button is tapped. WARNING! A potential hazard exists if different alarm presets are used for the same or similar equipment in any single area. WARNING! When turned off, the alarms will no longer be displayed or sound. Follow instructions above to turn on the alarms. CAUTION! Consult a physician the appropriate vital sign limits for the user before adjusting an alarm. 25 Default Alarm Settings Follow the instructions below to restore alarm settings to default values. 1. Ensure there is a connection established between the Display Unit and the Infant Oximeter Module. (See Device Pairing section on page 16 for more information.) NOTE: Default alarm can be restored only when the connection is established. 2. Tap on SETTING button located on the top right corner of the MAIN screen. 3. Tap on DEFAULT ALARM. 4. Tap on CONFIRM to restore alarm limits to manufacturer-configured values. NOTE: The following table describes the default alarm presets. Alarm SpO2 Upper Alarm Limit SpO2 Lower Alarm Limit Factory Default Off 85%
Pulse Rate Upper Alarm Limit 200 bpm Pulse Rate Lower Alarm Limit 75 bpm 26 Powering and Charging Powering the Display Unit The Display Unit is meant to be used with the GA-CD0002 Charging Adaptor- Display Unit 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. Insert the micro-USB cable end of the GA-CD0002 Charging Adaptor- Display Unit into the Display Unit and plug the wall adaptor to a power outlet. 2. Place the Display Unit on the stand provided. NOTE: The LED indicator will light red when charging and light blue when fully charged. CAUTION!
Only use adaptors supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. 27 Charging the Infant Oximeter Module Charge the Infant Oximeter Module with the wireless charging case by following the steps below. NOTE: The Display Unit will alarm the user when the Infant Oximeter Module is low on battery. Once on low battery, the Infant Oximeter Module will work for up to another 2 hours
(working time on low battery depends on user) 1. Connect the GA-CS0001 Charging Adaptor- Wireless Charging Case to wireless charging case and a power outlet. 2. Open the cover of the wireless charging case and place the Infant Oximeter Module inside as shown below. 3. Close the cover of the wireless charging case. NOTE: The power LED on the Infant Oximeter Module will light blue while charging and turn off, when fully charged. NOTE: The charging LED on wireless charging case will automatically light blue when charging SM and turn off, when not in use. It takes about 3 hours to fully charge the Infant Oximeter Module. NOTE:
NOTE: The Infant Oximeter Module will turn itself on automatically when the wireless charging case is opened; and, the power LED will light green when the power is ON. 28 CAUTION!
Only use the charging adaptor and wireless charger supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. 29 Care and Maintenance Maintenance The advanced digital circuitry within the Infant Oximeter Module of this system requires no calibration or periodic maintenance, neither does the Display Unit. Field service or repair of this system is not possible. Do not attempt to open the case. Opening the Infant Oximeter Module and the Display Unit will damage the device and void the warranty. If the system is not functioning properly, see Troubleshooting section on page 31 for more information. The expected service life of Aulisa GA1001 System is 1.5 year. Cleaning Clean surface of the sensor probe before each use. Clean the surface of the sensor probe with a soft cloth dampened with rubbing alcohol. Lightly wipe the surface of the sensor probe. CAUTION!
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. CAUTION!
Do not immerse the device in liquid, and do not use caustic or abrasive cleaning agents on the device. 30 Troubleshooting Problem Possible Solution Cannot turn on the Infant Oximeter Module Cannot turn on the Display Unit 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 Fully charge the Infant Oximeter Module until the charging blue light goes off, then remove SM from the wireless charger. Make sure the Infant Oximeter Module is kept away from any magnetic devices while charging. Press the power On/Off button for more than three (3) seconds. Make sure the power cord is properly connected to the outlet. Reposition the Infant Oximeter Module and keep the sensor motionless for at least 10 seconds. Warm the foot by rubbing or covering with a sock. Allow the foot to rest comfortably without squeezing or pressing the sensor on a hard surface. Relocate the Infant Oximeter Module at a different site. Make sure the Infant Oximeter Module is within 10 meters (32.8 feet) spherical radius to the Display Unit and that the devices are paired. Reduce or eliminate any interference. Make sure that the Infant Oximeter Module is not placed on the same leg being used for other patient therapies or diagnostics (e.g., blood pressure cuff). Make sure the Infant Oximeter Module is attached to the foot securely. Check the Display Unit for any alarms or error messages. Check the Infant Oximeter Module for power. Check the sensor for any visible signs of deterioration. Shield the sensor probe from the light source. Relocate the Infant Oximeter Module at a different site. Make sure the Infant Oximeter Module is attached to the foot securely. Check the sensor for any visible signs of 31 Problem Possible Solution deterioration. Reduce patient motion. Verify that the Infant Oximeter Module is paired with the Display Unit. Reposition the Infant Oximeter Module and keep the sensor motionless for at least 10 seconds. Relocate the Infant Oximeter Module at a different site. Make sure the Infant Oximeter Module is securely attached to the foot. Reposition the Infant Oximeter Module and keep the sensor motionless for at least 10 seconds. Relocate the Infant Oximeter Module at a different site. Turn off the unit, check all connections, and retry. Verify that the Infant Oximeter Module is paired with the Display Unit. Wait for two minutes and alarm tones will automatically re-engage. Make sure there are no headphones inserted into the headphone jack of the Display Unit. Turn off both the Infant Oximeter Module and the Display Unit. Follow instructions in the Device Pairing section on page 16. Ensure that the Infant Oximeter Module is in range while being paired (approximately 10 meters (32.8 feet) spherical radius). Data update period has exceeded limit A dash (---) appears in the vital sign displays. The unit is in Alarm mode, but no audible alarms can be heard. Cannot connect the devices If these solutions do not correct the problem, please contact your distributor, or contact Aulisa Customer Support at 1 (650) 813-1273
(USA). WARNING!
This system is a precision electronic instrument and must be repaired by knowledgeable and specially trained Aulisa personnel only. Do not attempt to open the case or repair the electronics. 32 Technical information 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 = (SpO2SaO2)2 n 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 GA1001 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 Sensor Accuracy
(Arms) 90%-100%
80%-90%
70%-80%
1.82 2.66 3.19 The graph below shows the error (SpO2 SaO2) plots of each subject measured by the Aulisa GA1001 System with upper and lower 95%
limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers. 33 Pulse Rate Accuracy Pulse rate accuracy has been functionally tested against an electronic pulse simulator from 30 to 300 bpm in 10bpm intervals, 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 passed the 3 digits acceptance criteria. Equipment Response Time Aulisa GA1001 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 GA1001 Digital Vital Sign Monitoring System. Equipment Delays Data Averaging Alarm Condition Delay Alarm Signal Generation Delay Data Update Period Delay (Seconds) 4 seconds 4 seconds 0 seconds 1 second 34 Manufactures Declaration Refer to the following table for specific information regarding compliance to IEC 60601-1-2 for this device. Guidance and manufacturers declaration - electromagnetic emissions - for all EQUIPMENT and SYSTEMS Guidance and manufactures 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 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker Emissions IEC 61000-3-3 Complies Complies 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. 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. Guidance and manufacturers declaration - electromagnetic immunity - for all EQUIPMENT and SYSTEMS Guidance and manufactures 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 Electrostatic Discharge (ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical Fast Transient/Burst IEC 61000-4-4 Surge IEC 61000-4-5 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines 1 kV differential mode 1 kV differential mode Electromagnetic environment -
guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be 35 2 kV common mode 2 kV common mode that of a typical commercial or hospital environment. 0% UT in 0.5 cycle at 0, 45, 90, 135, 180, 225, 270 and 315 0% UT in 1 cycle at 0 70% UT in 25/30 cycles at 0 0% UT in 250/300 cycles at 0 and 180 30 A/m 0% UT in 0.5 cycle at 0, 45, 90, 135, 180, 225, 270 and 315 0% UT in 1 cycle at 0 70% UT in 25/30 cycles at 0 0% UT in 250/300 cycles at 0 and 180 30 A/m Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 Power Frequency
(50/60 Hz) Magnetic Field 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. Guidance and manufacturers declaration - electromagnetic immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and Manufactures 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 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601-1-2 test level 3 V/m 150 kHz to 80 MHz 10 V/m 80 MHz to 2.7 GHz Compliance level 3 V/m 10 V/m Electromagnetic environment
- guidance Recommended Separation Distance The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
E = 6/dP 36 Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m. 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. 37 FCC Compliance 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. Use of other accessories may violate FCC RF exposure guidelines and should be avoided. 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 users authority to operate the equipment. WARNING!
No modifications to this device are allowed that in any way affect or alter its antenna or antenna configuration. 38 Service, Support, and Warranty A return authorization number is required before returning any product to Aulisa. To obtain this return authorization number, contact Aulisa Customer Support:
United States of America Aulisa Medical Technologies, Inc. 999 Commercial St, Suite 208 Palo Alto, CA 94303 USA Tel (650) 813-1273 Taiwan Taiwan Aulisa Medical Devices Technologies, Inc. No. 218-2, Chong Yang Rd., Nangang Dist, Taipei, 115 Taiwan Tel +886-2-2655-7297 www.aulisa.com 2018 Taiwan Aulisa Medical Devices Technologies, Inc. WARRANTY Taiwan Aulisa Medical Devices Technologies, Inc., warrants to the purchaser, for a period of one year from the date of purchase, Aulisa GA1001 Digital Vital Sign Monitoring System. Aulisa warrants the Infant Oximeter Module and Display Unit for a period of one year from the date of purchase. Aulisa shall repair or replace any Infant Oximeter Module and integrated Sensor(s) and Display Unit found to be defective in accordance with this warranty, free of charge, for which Aulisa has been notified by the purchaser by serial number that there is a defect, provided said notification occurs within the applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any Aulisa GA1001 Digital Vital Sign Monitoring System delivered to the purchaser which is found to be defective in any manner, whether such remedies be in contract, tort, or by law. This warranty excludes cost of delivery to and from Aulisa. All repaired units shall be received by the purchaser at Aulisa place of business. Aulisa reserves the right to charge a fee for a warranty repair request on any Aulisa GA1001 Digital Vital Sign Monitoring System that is found to be within specifications. This system is a precision electronic instrument and must be repaired by knowledgeable and specially trained Aulisa personnel only. Accordingly, 39 any sign or evidence of opening the devices, field service by non- Aulisa personnel, tampering, or any kind of misuse or abuse of the system, shall void the warranty in its entirety. All non-warranty work shall be done according to Aulisa standard rates and charges in effect at the time of delivery to Aulisa. DISCLAIMER/EXCLUSIVITY OF WARRANTY:
The express warranties set forth in this manual are exclusive and no other warranties of any kind, whether statutory, written, oral, or implied, including warranties of fitness for a particular purpose or merchantability, shall apply. 40 Specifications Aulisa GA1001 Digital Vital Sign Monitoring System Blood Oxygen Saturation Display Range (SpO2) Pulse Rate Display Range Accuracy 30 to 300 bpm 1% to 100%
Blood Oxygen Saturation
(%SpO2) ( 1 S.D.) 70-100% 3 digits Pulse Rate 3 digits Alarms SpO2 Default SpO2 Limit Upper Limit Lower Limit Alarm Limit Range Upper Limit Lower Limit Adjustment Step Step Value Pulse Rate Default Pulse Rate Limit Upper Limit Lower Limit Alarm Limit Range Upper Limit Lower Limit Adjustment Step Step Value Off 85%
85-100%
50-95%
1% SpO2 200 bpm 75 bpm 75-275 bpm 30-110 bpm 1 bpm Measurement Wavelengths and Radiant Power Red Infrared Wireless Communication Range Protocol Direction Data rate Temperature Operating Storage/Transportation Operating Altitude 660 nanometers @ 9.8 mW nominal 880 nanometers @ 6.5 mW nominal 10-meter spherical radius Bluetooth 4.0 Bi-direction Up to 100k Bps
+ 5C to + 40C 25C to+ 70C altitude 3000 m 41 Operating Storage/ Transportation Atmospheric Pressure Humidity 700 hPa to 1013 hPa 15% to 90%, non-condensing 10% to 93% relative humidity, non-
condensing Infant Oximeter Module (Sensors Integrated) Internal Power Battery Operating Life Dimensions Weight Ingress Protection Display Unit Display Display panel Power Requirements Mains DC Input Internal Power Battery Operating Life Dimensions Weight Alarm Sound Pressure Ingress Protection 3.7 V battery 22 hours of continuous operation 5.6 D x 1.2 W x 0.6 H 142.7 mm D x 31.3 mm W x 15.9 mm H 0.6 oz 17.5 g IP22 10.1 TFT Touch Panel 100-240 V AC 50-60 Hz 5 V DC/AC adaptor 3.7 V battery 2 hours of continuous operation 7.1 H x 10.8 W x 0.5 D 180.8 mm H x 275.5 mm W x 12.3 mm D 26.5 oz 750 g 60 dB IP22 Classifications per IEC 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 42 Parts and Accessories Parts and Accessories Infant Oximeter Module Display Unit Adhesive Patch Infant Oximeter Module Wireless Charging Case Infant Oximeter Module Charging Adaptor - Wireless Charging Case GA-CS0001 GA-CD0002 Charging Adaptor - Display Unit Stand - Display Unit GA-SD0002 Model Number GA-SM0002 GA-DU0002 GA-AP0001 GA- WS0001 For more information about Aulisa parts and accessories, contact your distributor, or contact Aulisa at 1 (650) 813-1273 (USA). WARNING!
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. 43 Taiwan Aulisa Medical Devices Technologies, Inc. No. 218-2, Chong Yang Rd. Nangang Dist, Taipei Taiwan Tel +886-2-2655-7297 www.aulisa.com 2018 Taiwan Aulisa Medical Devices Technologies, Inc. 44
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-06-11 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-06-11
|
||||
1 | Applicant's complete, legal business name |
Taiwan Aulisa Medical Devices Technologies, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0025735697
|
||||
1 | Physical Address |
10F., No.3-2, YuanQu St., Nangang Dist.
|
||||
1 |
Taipei City, N/A 11503
|
|||||
1 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@telefication.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AI5Q
|
||||
1 | Equipment Product Code |
GA-SM0002
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
A******** L******
|
||||
1 | Telephone Number |
+886-********
|
||||
1 | Fax Number |
+886-********
|
||||
1 |
A******@aulisa.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
International Standards Laboratory Corp.
|
||||
1 | Name |
D******** C****
|
||||
1 | Physical Address |
No. 120, Lane 180, Hsin Ho Rd., Lung-Tan Dist.
|
||||
1 |
Taiwan
|
|||||
1 | Telephone Number |
886-3******** Extension:
|
||||
1 | Fax Number |
886-3********
|
||||
1 |
d******@isl.com.tw
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
International Standards Laboratory Corp.
|
||||
1 | Name |
D******** C********
|
||||
1 | Physical Address |
No. 120, Lane 180, Hsin Ho Rd., Lung-Tan Dist.
|
||||
1 |
Taiwan
|
|||||
1 | Telephone Number |
886-3******** Extension:
|
||||
1 | Fax Number |
886-3********
|
||||
1 |
d******@isl.com.tw
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | 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 | 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 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Infant Oximeter Module | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Single Modular Approval | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | 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 | Grant Comments | Power Output is conducted. End-users must be informed of transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | 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 | Firm Name |
International Standards Laboratory LT lab.
|
||||
1 | Name |
B****** C********
|
||||
1 | Telephone Number |
886-3******** Extension:
|
||||
1 | Fax Number |
886-3********
|
||||
1 |
b******@isl.com.tw
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0038000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC