Combo Sensor ModuleECG and PPG Instructions For Use ____________________________________________________________ 7MN00050-01
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 Contradictions ................................................................................................................................ 6 Warnings ...........................................
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 health care professional only.
IP23 Classification for water ingress and particulate matter Date of Manufacturer Type CF applied part MR Unsafe
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. GA2000 Series The Combo Sensor Module is intended for use with the Display Unit and Receiver/Transponder.
. Clinical validation has not been performed on patients who are pregnant or breastfeeding. Precautions 1. To acquire physiological data properly: o The Combo Sensor Module must be properly adhered to the patient. o 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). o The Combo Sensor Module must have adequate power for data transmission.
Device Overview Device Components Sensor Box Holder Sensor Cable ECG Electrode PPG Adhesive Patch ECG/PPG Position Guide
Battery Charger Charging Adaptor- Battery Charger Device Description The Combo Sensor Module is a component of the Aulisa Digital Vital Sign Monitoring System. The Combo Sensor Module is a wireless, battery operated wearable biosensor, attached to the chest to continuously record blood pressure (BP), heart rate (HR), respiration rate (RR), electrocardiography (ECG) and fall detection of adult patients.
3 1 Power On/Off Button 2 Power LED 3 Battery Chamber 4 SD card 5 Cable port 4 5 1 2 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.
home care, and subacute environments. The Aulisa Combo Sensor Module is calibrated using a manual method or any AAMI 81060 compliant BP device. All parameters derived by Aulisa Combo Sensor Module are reported to Aulisa’s Digital Vital Sign Monitoring System via standard radio transmission protocols. Device Principle of Operation The Combo Sensor Module captures the bio-signals of electrocardiography (ECG) and Photoplethysmography (PPG).
Step 2: Prepare skin. NOTE: Ensure hands are clean and dry before handling the Combo Sensor Module. Gloves are recommended when handing the device. NOTE: When handling the Combo Sensor Module, do not touch the adhesive. The steps below should minimize the chance of touching the adhesive. Contact with the adhesive prior to application to the patient will deteriorate the adhesive and compromise wear duration. The application site is located on the upper left chest as shown below.
paper of the 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. Step 5: Power-on Combo Sensor Module. Locate and press the Power On/Off Button. Look for a green light illuminating to confirm the device is powered on. Step 6: Set up the GA1000 Series or GA2000 Series.
Device Pairing Automatic Pairing GA1000 Series The Display Unit automatically detects and connects to the Combo Sensor Module in the same starter kit. Press the "PAIR" button on the MAIN screen to force the system pairing when the connection is not established automatically. GA2000 Series The Receiver/Transponder automatically detects and connects to the Combo Sensor Module in the same starter kit only when the connection between the Display Unit and the Receiver/Transponder has been established first.
NOTE: Make sure the battery is installed and fully charged before use. NOTE: The Combo Sensor Module remains paired with the system until the serial number is deleted from the list. NOTE: The Combo Sensor Module must be placed within 32.8 feet (10 meters) to the Display Unit (for GA1000 Series), or to the Receiver/Transponder (for GA2000 Series). NOTE: The Power LED lights green when the power is ON. Device Power Off and Removal The device will be turned off by either way: 1.
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. Device SD card Installation and Removal The Combo Sensor Module contains a SD card for data storage. The SD card needs to be installed before using the device.
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.
Troubleshooting Problem Cannot power on the Combo Sensor Module Unusual vital sign data Cannot establish system connection Possible Solution 1. Recharge the battery. 2. Press the Power button again. 1. Recheck device's location or contact with the skin. 2. Ensure Sensor Cable is connected firmly to the Sensor Box. 3. Reduce patient motion. 4. Check the Sensor Cable for any visible signs of deterioration. 5. Use this device under instructed operation conditions. 1.
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.
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 ±2 kV common mode ±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 ±2 kV common mode ±0% UT in 0.
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.
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). FCC Radiation Exposure Statement For body worn operation, to maintain compliance with FCC RF exposure guidelines, use only accessories that contain nonmetallic components. RF exposure separation distance is 5 mm.
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Specifications Dimensions Weight Ingress Protection Display range Systolic Blood Pressure Diastolic Blood Pressure Heart Rate Respiration Rate Accuracy Blood Pressure Heart Rate Respiration Rate Battery Type Battery Life Temperature Operating Storage/Transportation Humidity Operating Storage/Transportation Operating Altitude Atmospheric Pressure Wireless Communication Range Protocol Direction Data rate 61.8mm x 60.7mm x 21.0mm 63.
Parts and Accessories Parts and Accessories Combo Sensor Box Combo Sensor Cable Combo Sensor Battery ECG Electrode PPG Adhesive Patch Battery Charger Charging Adaptor- Battery Charger Model Number GA-CB0001 GA-CA0001 GA-BA0001 GA-AP0012 GA-AP0004 GA-BC0001 GA-CR0002 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 (7MN0002202).
