870E Instruction for Use Version / V1.2EN Thank you for purchasing Vion.880E. Please read the instructions before use.
TABLE OF CONTENTS General Notes 1 Signs and Symbols Important Safety Notes 2 3 Product Description Main Features Package Contents Hardware Description LCD Display 5 6 7 8 Preparation Before Taking Measurement 9 Battery Installation 10 Battery Life and Replacement Cautions before Taking Measurement 11 Taking Measurement Operation Procedure Common Wrong Operations 12 14 Results Display Measurement Results Reviewing Results 15 16 BP ECG Studio System Requirements 17 18 Installation System Authentica
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 could be taken into consideration by medical professionals and enables self-health monitoring. 3. Self diagnosis or treatment is dangerous behavior.
INDICATION FOR USE INDICATION FOR USE Vion. ECG Pen (Model: 880E/870E) is intended to be used in individual channels of electrocardiogram (ECG) rhythms.
Important Safety Notes Do not use this device for children weighing less than 10 kgs. Do not use this device during an MRI scan. The electrodes of this device should not come in contact with other electrically conductive parts, including earth ground. Do not use this device with a defibrillator. Do not expose this device to static electricity. Always disperse any static electricity from your body before handling this device. 1 Do not submerge (or immerse) the device in water or liquid.
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. Keep the components of the device out of the reach of infants, toddlers or children. This device contains small parts(such as batteries) that may cause a choking hazard if swallowed by infants, toddlers or children.
Product Description Main Features Vion. 880E/870E can record personal electrocardiogram (ECG) for approximately 30 seconds of an adult individual. Package Contents Your package should include the following items. Main Unit Handheld ECG Measurement The handheld ECG design provides great convenience for home use. This patented ergonomic design not only makes detection easier, but also enables signals to be acquired with better resolution and be more conducive for analysis. Vion.
Product Description Hardware Description LCD Display Top Electrodes Product Description Product Description Heartbeat LED Power Button Micro USB Port 1 Heartbeat Indicator: Flashes in sync with heartbeats during measurement. 2 Heart Press 3 sec to turn on/ off. Battery Cover Rate: During recording: Displays the real-time heartbeat. During reviewing: Displays the average heart rate of each measurement. 3 Battery Detection Switch 4 USB Level Indicator: Shows current battery level.
Preparation before Taking Measurement Battery Installation Turn the device upside down. Remove the battery cover by inserting the tip of your finger into the opening of the cover. Slide back the battery cover until it clicks into place. Install or replace the batteries by following the + (positive) and- (negative) polarities indicated on the battery compartment. When the battery level indicator appears only with 1 bar left, the batteries are nearly running out, please replace new batteries timely.
Preparation before Taking Measurement Taking Measurement Cautions before Taking Measurement Operation Procedure Please read the cautions below to correctly measure your personal ECG : Do not attempt to use this device over or through clothing. Top Electrodes Preparation before Taking Measurement Taking Measurement If the electrodes are dirty, please use a soft cloth or a cotton swab moistened with disinfectant alcohol to clean dirt from the surface.
+Taking Measurement Operation Procedure There are three different methods of taking the measurement. Start with measurement method A, “right index finger-chest.” If this method does not deliver measurements, or delivers only unstable measurements (“EE” is frequently displayed), switch to method B “left index finger-chest” and, if necessary, to method C ”left hand-right hand.” The most suitable method/ procedure depends on the heart configuration (shape of the heart) of each individual user.
+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: Press it GENTLY until you hear the click sound. Note: Do not press the electrodes hardly. Excessive muscle tension will cause unnecessary noise. Measurement Method B “left index finger-chest” (approximately corresponds to “lead 3”) 1. Press the power button for 3 seconds to turn on your ECG Pen. 2.
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. Place your right index finger on the two top electrodes of the device. Place a finger of your left hand on the lower electrode. 3.
Taking Measurement Operation Procedure The device starts beeping, and the Digits Display flashes for a few seconds, indicating the measurement is about to start. Common Wrong Operations Please avoid the following operations: The right index finger is not in sufficient contact with top electrodes. Taking Measurement Taking Measurement Note: If the bottom electrode is released within 3 seconds at the beginning of your measurement, the measurement will be aborted.
Result Display Measurement Results The ECG measurement result will display as follows : : Normal Result Reviewing Results For reviewing the previous records, you may: Press the button for 3 seconds to turn on the device. The LCD displays the total number of records stored.
BP ECG Studio (870E not applicable) BP ECG Studio System Requirements Before installing BP ECG Studio, please check the system requirements listed below. Installation Please use the companion CD to install BP ECG Studio. Insert the CD to your computer. Operating System Browse the CD and double click Setup.exe to start the installation. Windows 7 or higher Recommended Hardware BP ECG Studio BP ECG Studio Intel Core i3-3220 3.
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 BP ECG Studio. Click [Install] to start the installation process. Double click the icon to run BP ECG Studio. The following message will be displayed. BP ECG Studio BP ECG Studio BP ECG Studio Click [Finish] to complete the installation process. Then, the icon will be shown on the desktop.
BP ECG Studio System Authentication Click [OK] to complete the authentication process. Then, the main window of BP ECG Studio will be launched. Downloading ECG Data to Computer To download ECG data to your computer: Create a new user account by clicking .1 Run BP ECG Studio. Fill in user information.2 Plug the connector of USB extension set into USB port of your computer. BP ECG Studio BP ECG Studio BP ECG Studio 1 You need to select a user account to log in every time.
BP ECG Studio Downloading ECG Data to Computer Make sure the connection is established. Click Main Window to enter data download. Disconnected Connected Records will be added into Data List at the right column. BP ECG Studio BP ECG Studio Click [ Download ] to download data from the device.1 Electrocardiogram Trace Grid Color Options Click to change the grid color into green or red. Scale Adjustment Zoom in / Zoom out / Reset the scale of signals.
BP ECG Studio Main Window Data List Main Window Help Measurement Note Note your symptoms, Medications or activities related to the measurement for further reference. Open the on-line Instruction for Use of BP ECG Studio. About Provide version and copyright information. Delete Multilingual Converter Click to change the interface to preferred languages. Disconnected / Connected Functions Menu User information Edit the user information. Configure Configure your device.
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. You can enable/disable the beep sound during your ECG measurement. BP ECG Studio BP ECG Studio Heart Beat Beep Default By clicking [Default], you can reset your device to factory default settings.
APP Download System Requirements : Smartphones or Tablets which support Bluetooth4.0 (BLE) APP Download Please scan the QR code to enter APP introduction web page, and follow the instructions to download and use the APP. Cleaning and Maintenance • Do not use any abrasive or volatile cleaners. • Please clean the device with a soft cloth dampened with water, then wipe them with a dry cloth.
Messages Message Shown The measurement result of averaged heart rate keeps flashing. Possible Cause Unstable or weak ECG signals. Failure analysis resulted from insufficient contact, an interruption, or high noise level during measurement. Suggestion Please follow the instructions on page 11~14 to retake the measurement. Please follow the instructions on page 11~14 to retake the measurement.
Vion.
Technical Specifications Vion ECG Pen Input signal range -400mV < Signal (DC+AC) < 400mV 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.
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. However, please be aware that MD biomedical will not be responsible for the loss of data and/or information in the app or personal computer. 8.
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. could result in increased electromagnetic emission or decreased electromagnetic immunity of the device and result in improper operation.
+FCC Statement CAUTION: To assure continued FCC compliance: Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment. 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.
MD Biomedical, Inc. 8F., No.222, Sec 4, Chengde Rd., Taipei City 111, Taiwan www.mdbiomedical.
