Related Manuals for Aulisa ECG
Summary of Contents for Aulisa ECG
- Page 1 Combo Sensor Module- ECG and PPG Instructions For Use ____________________________________________________________ 7MN00050-01...
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Page 2: Disclaimer
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. -
Page 3: Table Of Contents
Table of Content Disclaimer ............................2 Welcome ............................6 Contradictions ..........................6 Warnings ............................6 Device Overview ..........................8 Device Components ........................8 Device Description ........................9 Device Indications for Use ......................10 Device Principle of Operation ....................11 Device Setting Up .......................... 11 Device Pairing .......................... - Page 4 Guide to Symbols Symbol Description Refer to instruction manual 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...
- Page 5 Classification for water ingress and IP23 particulate matter Date of Manufacturer Type CF applied part MR Unsafe...
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Page 6: Welcome
Welcome This manual will help you get started with monitoring using the Combo Sensor Module of Aulisa Guardian Angel® Rx Digital Vital Sign Monitoring System, GA1000/ GA2000 Series. GA1000 Series The Combo Sensor Module is intended for use with the Display Unit. Refer to the GA1000 Series Instructions for Use (7MN00026-02) for detailed instructions. - Page 7 7. Clinical validation has not been performed on patients who are pregnant or breastfeeding. Precautions 1. To acquire physiological data properly: The Combo Sensor Module must be properly adhered to the patient. The patient must remain within 32.8 feet (10 meters) to the Display Unit (for GA1000 series), or to the Receiver/Transponder (for GA2000 series).
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Page 8: Device Overview
Device Overview Device Components Sensor Box Holder Sensor Cable ECG Electrode PPG Adhesive Patch ECG/PPG Position Guide... -
Page 9: Device Description
During normal operation, data is collected by the device and transmitted immediately to the Aulisa Digital Vital Monitoring System. Data is stored on a SD card and the data can be easily transferable to a personal computer to be viewed or printed. -
Page 10: Device Indications For Use
Cable port Sensor Cable The reusable double-ended cable contains three ECG leads and a PPG probe on one end and a Sensor Box connector on the other end. The Sensor Box connector is to be connected to the Sensor Box and, the ECG leads and PPG probe are to be attached to the chest. -
Page 11: Device Principle Of Operation
The Combo Sensor Module captures the bio-signals of electrocardiography (ECG) and Photoplethysmography (PPG). The device computes heart rate (HR) and respiration rate (RR) from QRS complexes of ECG, and it estimates blood pressure via Pulse Transit Time (PTT) measurement from ECG and PPG. - Page 12 Step 3: Position Combo Sensor Module on the body. Attach the ECG electrodes to the ECG leads of the Sensor Cable as shown below. Ensure they are well secured. Place the ECG/PPG Position Guide flat on the chest. Align the upper section of the ECG/PPG...
- Page 13 ECG electrodes. Attach the ECG electrodes onto the positions indicated by the ECG/PPG Position Guide. Then, place the PPG probe per the ECG/PPG Position Guide. Remove the ECG/PPG Position Guide and secure the PPG probe with the adhesive tape.
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Page 14: Device Pairing
Series) Step 3: Scan the QR Code or key in the serial number located on the back of the Aulisa X Box. Step 4: Check if the serial number (SN) displayed matches with the one on the Aulisa X Box. -
Page 15: Device Power Off And Removal
When removing the device, use of an adhesive tape remover is recommended. Gently sweep the remover pad under the device and pull away from the skin. NOTE: The adhesives are for Single Use Only. Do not reapply to the ECG electrode once it is removed. Device Charging The Combo Sensor Module is powered by a rechargeable battery. -
Page 16: Device Sd Card Installation And Removal
2. Plug the connector end of the charging adaptor into the cable port of the Battery Charger. Attach the wall adaptor to a power outlet. NOTE: The power LED of the battery charger lights green when it is plugged in. NOTE: The charging LED of the battery charger lights blue when the battery is charging. -
Page 17: Alarm
Alarm For more information about the alarm, refer to the GA1000 Series Instructions for Use (7MN00026-02) or GA2000 Series Instructions for Use (7MN00022-02). Care and Maintenance The advanced digital circuitry within the Combo Sensor Module requires no calibration or periodic maintenance, except for the blood pressure feature which needs to be calibrated manually or with any AAMI 81060 compliant BP device for the first time use and every 4 hours of use. -
Page 18: Troubleshooting
For additional troubleshooting, refer to the GA1000 Series Instructions for Use (7MN00026-02) or GA2000 Series Instructions for Use (7MN00022-02). If these solutions do not correct the problem, please contact your distributor, or contact Aulisa by going online at www.aulisa.com under "Contact Us". -
Page 19: Manufacturer's Declaration
Manufacturer’s Declaration Refer to the following table for specific information regarding compliance to IEC/ EN 60601-1-2 for this device. Guidance and manufacturer’s declaration - electromagnetic emissions - for all EQUIPMENT and SYSTEMS Guidance and manufacture’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. - Page 20 ±2 kV common ±2 kV common mode or hospital mode environment. ±0% UT in 0.5 cycle ±0% UT in 0.5 cycle at at 0°, 45°, 90°, 135°, 0°, 45°, 90°, 135°, Voltage dips, short 180°, 225°, 270° and 180°, 225°, 270° and interruptions, Mains power quality 315°...
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Page 21: Fcc Compliance
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. -
Page 22: Service, Support, And Warranty
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 user's authority to operate the equipment. -
Page 23: Changes
TERMS OF THIS PRIVACY POLICY. IF YOU DO NOT AGREE, PLEASE DO NOT USE THE DEVICES AND DO NOT SUBMIT ANY INFORMATION TO US. Access to and use of the Devices by a Provider who is an Aulisa customer (a “Customer”) and such Customer's authorized users is subject to and governed by the agreement between Aulisa and the applicable Customer executed by authorized representatives of each party (the “Customer Agreement”). - Page 24 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...
- Page 25 customer service, and reference purposes.
- Page 26 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-identified and/or anonymized format with its affiliates, agents and other healthcare research and services entities, including without limitation insurance and pharmaceutical companies.
- Page 27 ❖ How Do You Protect My Personal Information? Aulisa is committed to protecting the security and confidentiality 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...
- Page 28 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.
- Page 29 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.
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Page 30: Specifications
Specifications Dimensions 61.8mm x 60.7mm x 21.0mm Weight 63.5 g Ingress Protection IP23 Display range Systolic Blood Pressure 75 to 225 mmHg Diastolic Blood Pressure 45 to155 mmHg Heart Rate 30 to 290 bpm Respiration Rate 10 to 30 bpm Accuracy Blood Pressure ±... -
Page 31: Parts And Accessories
For more information about the Display Unit and Receiver/Transponder, refer to the GA1000 Series Instructions for Use (7MN00026-02) or GA2000 Series Instructions for Use (7MN00022- 02). You may also contact your distributor or contact Aulisa by going online at www.aulisa.com under "Contact Us". CAUTION!!! Using accessories not by Taiwan Aulisa Medical Devices Technologies, Inc.
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