Summary of Contents for Vion 880E
- Page 1 870E Instruction for Use Version / V1.2EN Thank you for purchasing Vion.880E. Please read the instructions before use.
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Page 2: Table Of Contents
TABLE OF CONTENTS APP Download General Notes Signs and Symbols Cleaning and Maintenance Important Safety Notes Messages Product Description Trouble Shooting Main Features Technical Specifications Package Contents Hardware Description LCD Display Preparation Before Taking Measurement Battery Installation Battery Life and Replacement Cautions before Taking Measurement Taking Measurement Operation Procedure... -
Page 3: General Notes
General Notes Signs and Symbols 1. This Instruction for Use is for Vion.880E/870E. Following signs and symbols are used in the Instruction for Use, on the packaging and label of the device and accessories : 2. This is an Electrocardiogram (ECG) device that provides referential data that... - Page 4 (when used under the . The recorded ECG signals can be While Vion ECG Pen 880E/870E is a state of the art home-use instructions of a physician) promptly transferred to personal mobile devices such as ECG medical device for self-monitoring and record-keeping of computers(870E not applicable) or cellular phones.
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Page 5: Important Safety Notes
Important Safety Notes Do not use this device for children weighing less than 10 kgs. It is not recommended to use this device with a cardiac pacemaker or other implanted devices. Be sure to follow your doctor’s instruction if necessary. Do not use this device during an MRI scan. - Page 6 Store the device in safe place to avoid small parts swallowed by children in any circumstances. Under the environment temperature of 40°C, the temperature of applied part (ECG electrodes) will reach 42°C highest. This device has not been validated for use on pregnant patients. ...
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Page 7: Product Description
Product Description Main Features Package Contents Vion. 880E/870E can record personal electrocardiogram (ECG) for Your package should include the following items. approximately 30 seconds of an adult individual. Instant Feedback after Measurement Vion.880E/870E Main Unit This device automatically provides referential results analyzed from the recorded 30 seconds ECG data. -
Page 8: Hardware Description
Product Description Hardware Description LCD Display Top Electrodes Heartbeat LED Micro USB Port Heartbeat Indicator: Flashes in sync with heartbeats during measurement. Power Button Heart Rate: Press 3 sec to turn on/ off. During recording: Displays the real-time heartbeat. Battery Cover During reviewing: Displays the average heart rate of each measurement. -
Page 9: Preparation Before Taking Measurement
Preparation before Taking Measurement Battery Installation Battery Life and Replacement Turn the device upside down. Install or replace the batteries by following the + (positive) and- (negative) polarities indicated on the battery compartment. Remove the battery cover by inserting the tip of your finger into the opening of the cover. -
Page 10: Cautions Before Taking Measurement
Taking Measurement Preparation before Taking Measurement Cautions before Taking Measurement Operation Procedure Please read the cautions below to correctly measure your personal ECG : Press the po Do not attempt to use this device over or through clothing. Top Electrodes If the electrodes are dirty, please use a soft cloth or a cotton swab moistened with disinfectant alcohol to clean dirt from the surface. -
Page 11: Operation Procedure
+Taking Measurement +Taking Measurement Measurement Method A Operation Procedure “right index finger-chest” (approximately corresponds to “lead 2”) There are three different methods of taking the measurement. Start with 1. Press the power button for 3 seconds to turn on your ECG Pen. measurement method A, “right index finger-chest.”... - Page 12 +Taking Measurement +Taking Measurement 3. You can determine the correct position for placing the lower electrode of the device against your chest using the following methods: Place the bottom electrode of the ECG Pen on bare skin about 5 centimeters (2 inches) below your left nipple supported by the ribcage, and press it GENTLY until you hear the click sound.
- Page 13 Taking Measurement Taking Measurement unnecessary noise. not move during the measurement, do not speak and hold the device still. Movements of any kind will falsify the measurements. Measurement Method C “left hand-right hand” (approximately corresponds to “lead 1”) 1. Press the power button for 3 seconds to turn on your ECG Pen. 2.
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Page 14: Common Wrong Operations
Taking Measurement Operation Procedure Common Wrong Operations The device starts beeping, and the Digits Please avoid the following operations: Display flashes for a few seconds, indicating the measurement is about to start. Measuring over or through clothing. The right index finger is not in sufficient contact with top electrodes. -
Page 15: Results Display
Result Display Measurement Results Reviewing Results The ECG measurement result will display as follows : For reviewing the previous records, you may: Press the button for 3 seconds to turn : Normal Result on the device. The LCD displays the total number of records stored. -
Page 16: Bp Ecg Studio
BP ECG Studio BP ECG Studio (870E not applicable) System Requirements Installation Before installing BP ECG Studio, please check the system requirements Please use the companion CD to install BP ECG Studio. listed below. Insert the CD to your computer. Browse the CD and double click Setup.exe to start the installation. -
Page 17: System Authentication
BP ECG Studio Installation System Authentication The process of system authentication will be needed as BP ECG Studio is executed for the first time. Select the folder for installing Click [Install] to start the BP ECG Studio. installation process. Double click the icon to run The following message will be displayed. -
Page 18: Downloading Ecg Data To Computer
BP ECG Studio System Authentication Downloading ECG Data to Computer Click [OK] to complete the Then, the main window of To download ECG data to your computer: authentication process. BP ECG Studio will be launched. Create a new user account by Run BP ECG Studio. -
Page 19: Main Window
BP ECG Studio Downloading ECG Data to Computer Main Window Make sure the connection is Click to enter data download. established. Disconnected Connected Click [ Download ] to download Records will be added into Data data from the device. List at the right column. Electrocardiogram Trace Grid Color Options Click... - Page 20 BP ECG Studio Main Window Main Window Data List Help About Open the on-line Instruction Provide version and copyright Measurement Note for Use of BP ECG Studio. information. Note your symptoms, Medications or activities related to the measurement for further reference. Delete Multilingual Converter Delete the selected ECG data...
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Page 21: Configuration
BP ECG Studio Configuration Configuration In the configuration To configure your device, click to open the configuration window. window: Date/ Time You can set the date/ time manually or set it to sync with the computer. Key Beep You can enable/disable the beep sound when the device is operating. Heart Beat Beep You can enable/disable the beep sound during your ECG measurement. -
Page 22: App Download
APP Download Cleaning and Maintenance • Do not use any abrasive or volatile cleaners. System Requirements : Smartphones or Tablets which support Bluetooth4.0 (BLE) • Please clean the device with a soft cloth dampened with water, then wipe them with a dry cloth. •If electrodes are dirty, please use a soft cloth or a cotton swab moistened with 70~75% alcohol to clean the electrodes. -
Page 23: Messages
Messages Trouble Shooting Message Shown Possible Cause Suggestion Problem Possible Cause Suggestion The measurement Unstable or weak The device cannot be 1. Battery power is low. 1. Replace with new Please follow the result of averaged ECG signals. turned on after batteries. - Page 24 Vion. ECG Pen 880E / 870E...
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Page 25: Technical Specifications
Technical Specifications Input signal range -400mV < Signal (DC+AC) < 400mV Vion ECG Pen Input Impedance > 10M Ohms Model Vion.880E/870E A/D resolution 16 bits Induction System single channel, bipolar Interface USB or Bluetooth 4.0 Bandwidth 0.05 ~ 40Hz Service Life... - Page 26 Technical Specifications 6. If any parts of the device are loosen, damaged or deformed, please contact the qualified distributor or the manufacturer MD Biomedical, Inc. to replace 7. MD biomedical will provide limited warranty and support updates of PC software and mobile device applications during the life cycle of the device.
- Page 27 EMC Information EMC Information Important information regarding Electromagnetic Compatibility (EMC) This device manufactured by MD Biomedical, Inc. conforms to IEC60601-1-2 Electromagnetic Compatibility (EMC) standard. Nevertheless, special precautions need to be observed: *The use of accessories and cables other than those specified or provided by MD Biomedical, Inc.
- Page 28 +FCC Statement +FCC Statement CAUTION: To assure continued FCC compliance: interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does Any changes or modifications not expressly approved by the grantee of this cause harmful interference to radio or television reception, which can be device could void the user's authority to operate the equipment.
- Page 29 MD Biomedical, Inc. 8F., No.222, Sec 4, Chengde Rd., Taipei City 111, Taiwan www.mdbiomedical.com...