Aulisa Oximeter Module F Instructions For Use ____________________________________________________________ 7MN00068-00
Disclaimer 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.
Table of Content Disclaimer........................................................................................................................................ 2 Welcome ......................................................................................................................................... 6 Contraindications ........................................................................................................................... 6 Warnings .............................................
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.
Temperature limit Non-sterile IP23 Classification for water ingress and particulate matter Date of Manufacturer MR Unsafe
Welcome This manual will help you get started with monitoring using the Aulisa Oximeter Module of Guardian Angel® Rx Digital Vital Sign Monitoring System (herein referred to as Aulisa Digital Vital Sign Monitoring System). The Aulisa Oximeter Module is intended for use with Aulisa Digital Vital Sign Monitoring System. Refer to the system Instructions for Use for detailed instructions. Contraindications 1. Do not use any part of this device in an MRI environment. 2.
hemoglobin, such as methemoglobin, might affect the accuracy of the measurement. 13. Use this device only when it is within the specified distances, approximately 32.8 feet (10 meters) spherical radius to the Aulisa Digital Vital Sign Monitoring System. Moving outside this range may cause missing, lost, and/or inaccurate data. 14. 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. 15.
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 device to extreme hot or cold temperatures, humidity, or direct sunlight. 16. Do not fasten this device too tightly around the foot. Inaccurate readings and discomfort could result. 17. System connection failure (Bluetooth connection) may result in loss of data transfer. 18.
Device Overview Device Components Oximeter Box Adult Reusable Oximeter Sensor Cable Pediatric Reusable Oximeter Sensor Cable Adult/Pediatric Disposable Oximeter Sensor Cable
Wristband Charging Adaptor Device Description The Aulisa Oximeter Module is a component of the Aulisa Digital Vital Sign Monitoring System. The Aulisa Oximeter Module is comprised of the Oximeter Box and a sensor cable i.e. Adult Reusable Oximeter Sensor Cable, Pediatric Reusable Oximeter Sensor Cable or Adult/Pediatric Disposable Oximeter Sensor Cable. The device is worn on the wrist to continuously record SpO2 and pulse rate of adult and pediatric patients.
Power On/Off button Oximeter Box Charging Port/Sensor Port Adult Reusable Oximeter Sensor Cable The Adult Reusable Oximeter Sensor Cable is intended to be attached to the Oximeter Box on one end and worn on the adult’s finger on the other end. Pediatric Reusable Oximeter Sensor Cable The Pediatric Reusable Oximeter Sensor Cable is intended to be attached to the Oximeter Box on one end and worn on the pediatric finger on the other end.
Device Indications for Use The Aulisa Oximeter Module is intended to measure SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by Aulisa Oximeter Module are transmitted to Aulisa’s Digital Vital Sign Monitoring System for display.
Step 3: Wear the Oximeter Box as a watch around the wrist. Secure the Wristband holding the Oximeter Box onto the patient’s wrist. Adjust the wristband according to wrist size, ensuring it is well fastened. Step 4: Attach the sensor probe to the finger. If you use the reusable sensor cable, insert the sensor probe to the finger. For the disposable sensor cable, follow the steps below. Peel the transparent plastic film off the probe patch.
Step 7: Connect Aulisa Oximeter Module to the system. Wait for the wireless connection of the system to be established. Once connected, the vital signs of the Aulisa Oximeter Module status information will appear on the MAIN screen. NOTE: Refer to “Device Pairing” section below for more information. NOTE: The device must be used within 32.8 feet (10 meters) spherical radius to Aulisa Digital Vital Sign Monitoring System.
Device Pairing Automatic Pairing The system automatically scans and pairs to the Aulisa sensor module(s) from the same starter kit. NOTE: The device must be placed within 32.8 feet (10 meters) spherical radius to Aulisa Digital Vital Sign Monitoring System. NOTE: The Bluetooth connection status icon will turn blue once the pairing succeeds. Manual Pairing Follow the below instructions to manually setup pairing of a new Aulisa Oximeter Module.
Device Power Off and Removal The device will be turned off by pressing the Power On/Off button on the Oximeter Box. When removing the disposable oximeter sensor cable, it is recommended to spray 75% alcohol on the patch to facilitate removal. Device Charging The Aulisa Oximeter Module is powered by a rechargeable battery. When the low battery alarm appears on the MAIN screen of the Display Unit, the battery is exhausted and needs recharging. Follow the instructions below to recharge the battery.
Alarm For more information about the alarm, refer to the Instructions for Use of Aulisa Digital Vital Sign Monitoring System. Care and Maintenance The advanced digital circuitry within the Aulisa Oximeter Module requires no calibration or periodic maintenance. Field service or repair of this system is not possible. Do not attempt to open the case other than the battery cover for that will cause damage and void the warranty.
Reuse Life The Oximeter Box and the Reusable Oximeter Sensor(s) are reusable with an expected life of 1.5 years. However, if you notice any signs of deterioration from below, stop using it and replace it with a new one or contact Aulisa Customer Support by going online at www.aulisa.com: button malfunctions; cracks appear on external case; edge of the gel covering the sensor probe window starts curling up; the strap frays or breaks and the wires inside become exposed.
Troubleshooting Problem Cannot power on the Aulisa Oximeter Module Unable to obtain a valid SpO2 or pulse rate reading NOTE: In some instances, perfusion of person being monitored may be inadequate for pulse detection. Unstable or constant SpO2 and Possible Solution 1. Make sure the Aulisa Oximeter Module is kept away from any magnetic devices while using. 2. Fully charge the Aulisa Oximeter Module. 1. Reposition the Aulisa Oximeter Sensor(s) and keep it motionless for at least 10 seconds. 2.
Pulse Rate readings 2. 3. 4. “---“ appears on the vital sign displays 5. 1. 2. 3. 4. 5. Data update period has exceeded the limit 1. 2. Cannot establish system connection 1. 2. source. Position the Aulisa Oximeter Sensor(s)to a different site. Make sure the Aulisa Oximeter Module is attached to the wrist and finger securely. Check the sensor probe for any visible signs of deterioration. Reduce motion of person being monitored.
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 bias* 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.
Arms from the Clinical Studies The graph below shows the error (SpO2 – SaO2) plots of each subject measured by this device with upper and lower 95% limits of agreement. Each sample data point is from a clinical study in healthy adult volunteers.
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.
Manufacturer’s Declaration Refer to the following table for specific information regarding compliance to IEC 60601-1-2 for this device. *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.
*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. Electromagnetic IEC 60601-1-2 test Immunity test Compliance level environment level guidance Floors should be wood, concrete, or ceramic tile.
*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.
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 undesignated operation.
user's authority to operate the equipment. CAUTION!!! No modifications to this device are allowed that in any way affect or alter its antenna or antenna configuration.
Service, Support, and Warranty 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 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.
Provider Users: The data controller is Taiwan Aulisa Medical Devices Technologies, Inc., No. 2182, Chong Yang Rd., Nangang Dist., 11573 Taipei City, Taiwan Data Protection Officer: Anne Kuo BY USING THE DEVICES, YOU ARE ACKNOWLEDGING THAT YOU HAVE READ AND AGREE TO THE TERMS OF THIS PRIVACY POLICY. IF YOU DO NOT AGREE, PLEASE DO NOT USE THE DEVICES AND DO NOT SUBMIT ANY INFORMATION TO US.
information to your healthcare provider. Primarily, the collection of your Personal Information assists us in providing a means to track your vital signs in order to better enable you to communicate information with caregivers and healthcare providers and be an active participant with those providers in monitoring your care, tailoring interventions, and assessing treatment outcomes.
Aggregated Personal Data: In an ongoing effort to better understand and serve our customers, other users of the Devices, and communities of people 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.
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 specific function.
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 e mail address that you have provided to us or other reasonable notification.
to lodge a complaint with a supervisory authority. 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 information@aulisa.com. You can also exercise the rights listed above at any time by contacting us at information@aulisa.com.
Specifications Dimensions Weight Ingress Protection Display range 1.87” x 1.82” x 0.63” (47.5mm x 46.2mm x 15.
Parts and Accessories Parts and Accessories Oximeter Box Adult Reusable Oximeter Sensor Cable Pediatric Reusable Oximeter Sensor Cable Adult/Pediatric Disposable Oximeter Sensor Cable Wristband Charging Adaptor Model Number GA-OB0003 GA-RS0005 GA-RS0006 GA-DS0003 GA-LB0002 GA-AD0001 For more information about the Aulisa Digital Vital Sign Monitoring System, refer to the system Instructions for Use. You may also contact your distributor or contact Aulisa by going online at www.aulisa.
