870E Instruction for Use Version / V1.2EN Thank you for purchasing Vion.880E. Please read the instructions before use. APP Download Cleaning and Maintenance Messages Trouble Shooting Technical Specifications 29 30 31 32 33 TABLE OF CONTENTS General Notes Signs and Symbols Important Safety Notes Product Description Main Features Package Contents Hardware Description LCD Display 1 2 3 5 6 7 8 Preparation Before Taking Measurement Battery Installation Battery Life and Replacement 9 10 Cautions before Taking Measurement 11 Taking Measurement Operation Procedure Common Wrong Operations Results Display Measurement Results Reviewing Results BP ECG Studio System Requirements Installation System Authentication 12 14 15 16 17 18 20 Downloading ECG Data to Computer 22 Main Window 24 Configuration 27 G e n e r a l N o t e s 1 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 could be taken into consideration by medical professionals and enables self-health monitoring. 3. Self diagnosis or treatment is dangerous behavior. Please dont use the electrocardiogram or data generated by the device to diagnose yourself. Consult with medical professionals if you notice any change in your condition, regardless of the measurement results. 4. The measurement result provided by the device only reflects the measurement taken at the moment. 5. The electrocardiogram cannot show all variations and symptoms of the heart disease, please consult with medical professionals when feeling discomfort with your heart. 6. Please follow the national requirement to dispose unit/accessories/waste products/residues/batteries etc. Type CF applied part ATTENTION, should read the Instruction for Use Consult Instruction for Use Manufacturer Date of manufacture Reference number Serial number Batch number i S g n s a n d S y m b o s l The product is with Bluetooth function Protection against solid foreign objects of 12.5 mm and greater and against vertically falling water drops when enclosure tilted up to 15 This way up Fragile Keep dry Keep away from sunlight Permissible operating temperature and humidity Permissible storage/transport temperature and humidity 2 INDICATION FOR USE INDICATION FOR USE Vion. ECG Pen (Model: 880E/870E) is intended to be used in individual channels of electrocardiogram (ECG) rhythms. Vion measuring heart rate, recording and analyzing ECG signal, then ECG Pen 880E/870E can also detect the presence of atrial storing and displaying general information for adult population fibrillation, bradycardia, tachycardia, and normal sinus rhythm who are concerned about their heart conditions during everyday
(when prescribed or used under the care of a physician). This life. This Vion ECG Pen 880E/870E allows users to record device is intended to be used by healthcare professionals, transient cardiac events up to 9 leads voluntarily anytime or at patients with known or suspected heart conditions, and healthy the time of symptomatic cardio discomfort (when used under the individuals. instructions of a physician). The recorded ECG signals can be While Vion ECG Pen 880E/870E is a state of the art home-use 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. At the same users cardio conditions, but it is not intended to substitute a time, these data can be transmitted to physician as reference conventional 12 leads ECG diagnostic tool. immediately, during office visits, or for telemedicine purpose. Users with implanted pacemakers are not recommended to use This device is capable of measuring and displaying up to 9 this device. I m p o r t a n t S a f e t y N o t e s Important Safety Notes It is not recommended to use this device with a cardiac pacemaker or other implanted devices. Be sure to follow your doctors instruction if necessary. Do not use this device during an MRI scan. 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. Do not clean the device with acetone, or other volatile solution. Do not put the device in autoclaves, or gas sterilization devices. Avoid hitting, dropping, stamping, shaking of the device. Do not disassemble this device that may result in damage, malfunction, or abnormal operation. Do not use this device on people with sensitive skin or allergies. Do not use the device if there are wounds on your contacted area or skin irritation/inflammation on/near the contacted area while performing measurement Do not use this device for children weighing less than 10 kgs. The electrodes of this device should not come in contact with other electrically conductive parts, including earth ground. Do not store/expose the device in the following environments:
Locations exposed to direct sunshine, high temperature or humidity, heavy dirt, near water or fire, and under high electromagnetic influence. Do not use other USB extension cord besides the companion USB extension set to connect the device with computer. The companion USB extension set is especially designed for avoiding electrical shock if come in direct contact with electrodes when connecting to computer.(870E N/A) Do not leave this device unattended with infants or persons who cannot express their consent. Do not operate this device in a moving vehicle (car, airplane). Do not use mobile phones, or other devices that emit electromagnetic fields near this device which may result in incorrect operation of the device. Remove batteries if won't be using this device for some time, to prevent battery to expand, leak and possibly destroy the device. I m p o r t a n t S a f e t y N o t e s Store the device in safe place to avoid small parts swallowed by children in any circumstances. Under the environment temperature of 40C, the temperature of applied part (ECG electrodes) will reach 42C 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. 1Static electricity may cause damage to the electronic components. To prevent electrostatic damage to the device, ensure your body is free of static electricity before using the device. Contact with earthed objects or devices, increase humidity, and moisturize skin can effectively reduce the cause of electrostatic damage. 4 P r o d u c t D e s c r i p t i o n 5 Product Description Vion. 880E/870E can record personal electrocardiogram (ECG) for approximately 30 seconds of an adult individual. Your package should include the following items. Main Features Package Contents Instant Feedback after Measurement This device automatically provides referential results analyzed from the recorded 30 seconds ECG data. 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. Multifunctional Software(870E not applicable) BP ECG Studio software can assist you to :
Download ECG data. Configure your device. Review measurement records in chronicle order. Display ECG waveforms to doctors for reference. Main Unit Vion.880E/870E USB extension set (870E not applicable)1 Accessories Instruction for Use 2 x coin-typed batteries (trial use) BP ECG Studio CD(870E not applicable) Bluetooth 4.0 With Bluetooth 4.0 technology, this device ideally provides real-time display of your measurement on Smartphones/Tablets for a great portability of reviewing your records anytime, anywhere. 1 The USB extension set is for downloading ECG data to your computer. Do not use other USB extension cord besides the companion USB extension set to connect the ECG Pen with computer. The companion USB extension set is especially designed for avoiding electrical shock if come in direct contact with electrodes when connecting to computer. P r o d u c t D e s c r i p t i o n 6 P r o d u c t D e s c r i p t i o n 7 Product Description Hardware Description Top Electrodes LCD Display Heartbeat LED Power Button Press 3 sec to turn on/ off. Detection Switch Micro USB Port 1 Heartbeat Indicator: Flashes in sync with heartbeats during measurement. Battery Cover Bottom Electrode 2 Heart Rate:
During recording: Displays the real-time heartbeat. During reviewing: Displays the average heart rate of each measurement. 3 Battery Level Indicator: Shows current battery level. 4 USB Connection: Displays the status of USB connection.(870E not applicable) 5 Digits Display:
During ECG Recording : Displays the 30 seconds count down. During Reviewing : Displays the sequence numbers of stored records. 6 Bluetooth Connection: Displays the status of Bluetooth connection. 7 Time: Displays date and time. P r o d u c t D e s c r i p t i o n 8 P r e p a r a t i o n b e f i o r e T a k n g M e a s u r e m e n t 9 Preparation before Taking Measurement Battery Installation Battery Life and Replacement Turn the device upside down. Remove the battery cover by inserting the tip of your finger into the opening of the cover. Install two CR2032 coin-typed batteries by following the + (positive) and
- (negative) polarities indicated on the battery compartment. 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. Note: Turn the device off before replacing batteries. Two new CR2032 coin-typed batteries will last for approximately 500 measurements. Please use same brand and type of batteries and replace all batteries at the same time. Avoid using used and new batteries together. Do not use rechargeable batteries. Remove batteries if won't be using this device for some time, to prevent the device from being damaged. Please dispose waste batteries according to applicable local regulations. P r e p a r a t i o n b e f i o r e T a k n g M e a s u r e m e n t 10 Preparation before Taking Measurement Cautions before Taking Measurement Please read the cautions below to correctly measure your personal ECG :
Taking Measurement Do not attempt to use this device over or through clothing. Press the po If the electrodes are dirty, please use a soft cloth or a cotton swab moistened with disinfectant alcohol to clean dirt from the surface. If your skin or hands are dry, moisten them with damp cloth before taking measurement. Do not let your right hand in contact with your body during the measurement, and avoid heavily pressing the top and bottom electrodes to influence the accuracy of measuring. Do not use the device in upside down position. Do not move or talk while taking measurement and keep the balance of your body to avoid influencing the accuracy of measurement result Ideally perform the measurement either sitting down or lying down. Do not stand up to take the measurement. Operation Procedure Top Electrodes i T a k n g M e a s u r e m e n t Click P r e p a r a t i o n b e f i o r e T a k n g M e a s u r e m e n t
+Taking Measurement
+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. If it is not possible to take stable measurements using a given measurement method, this could have a harmless cause such as the shape of the heart. However, the cause may also be an illness or disease. Note: Measurement method C offers maximum comfort, but offers a much lower measurement stability than methods A or B. Press the on/ off button for about three seconds to turn the device on. The device shows the full display. WARNING If segments are missing, stop using the device and immediately contact customer services. To test whether the full display is completely displayed, hold the On/Off button when switching on the device. Measurement Method A right index finger-chest (approximately corresponds to lead 2) 1. Press the power button for 3 seconds to turn on your ECG Pen. 2. Lay your right index finger on the two top electrodes of the device and hold the ECG Pen face up in your hand. 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. Draw an imaginary line from the front of your armpit downwards. At the same time, draw an imaginary line going up 10cm from the lowest rib on the left side of your body. Place the lower electrode of the device at the point where these two lines meet. Draw an imaginary line from the bottom of the centre of your chest
(sternum) to the left. At the same time, draw an imaginary line from the front of your armpit downwards. Place the lower electrode of the device at the point where these two lines meet.
+Taking Measurement 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. Lay your left index finger on the two top electrodes of the device and hold the ECG Pen face up in your hand.
+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. Draw an imaginary line from the front of your armpit downwards. At the same time, draw an imaginary line going up 10cm from the lowest rib on the left side of your body. Place the lower electrode of the device at the point where these two lines meet. Draw an imaginary line from the bottom of the centre of your chest
(sternum) to the left. At the same time, draw an imaginary line from the front of your armpit downwards. Place the lower electrode of the device at the point where these two lines meet. Press it GENTLY until you hear the click sound. Note: Do not press the electrodes hardly. Excessive muscle tension will cause Taking Measurement unnecessary noise. 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. Press the lower electrode until you hear or feel a click. Taking Measurement not move during the measurement, do not speak and hold the device still. Movements of any kind will falsify the measurements. Press it GENTLY until you hear the click sound. Note: Do not press the electrodes hardly. Excessive muscle tension will cause unnecessary noise. Note: Please note that there must be no skin contact between your right and left hand (measurement method C) or hand and chest (measurement methods A/B). Otherwise, the measurement cannot be taken correctly. Do i T a k n g M e a s u r e m e n t 13 Taking Measurement Operation Procedure Common Wrong Operations The device starts beeping, and the Digits Display flashes for a few seconds, indicating the measurement is about to start. Please avoid the following operations:
The right index finger is not in sufficient contact with top electrodes. Measuring over or through clothing. Note: If the bottom electrode is released within 3 seconds at the beginning of your measurement, the measurement will be aborted. The measurement will be completed after 30 seconds, and you may see the results shown on the LCD. i T a k n g M e a s u r e m e n WRONG WRONG t Holding the device in the wrong direction. Holding the device with left hand. Note: The latest measurement will replace the oldest one when the memory is full
(36 measurements). WRONG WRONG 14 Result Display Measurement Results Reviewing Results The ECG measurement result will display as follows :
For reviewing the previous records, you may:
R e s u l t i D s p a y l
: Normal Result
: Slow Heart Rate (<60 bpm) Bradycardia
: Fast Heart Rate
(>100bpm) Tachycardia
: Paused Heartbeat
: Irregular Rhythm
: Abnormal Waveform Please retake the measurement if the displayed heart rate is flashing, which indicates ECG signals are unstable or weak. Note1: Method of determining a PAUSE-Indicate one ore more pauses in the cardiac cycle, each of which is longer than 2 seconds. Note2: Method of calculating heart rate-Take the R-R duration between two identical points of consecutive ECG waveforms and divide it into 60. The resulting equation: Heart Rate = 60/(R-R interval) 15 button for 3 seconds to turn Press the on the device. The LCD displays the total number of records stored. button again, and the LCD Press the displays the average heart rate of the latest measurement and the Digits Display shows the sequence number of stored records. By pressing the cyclic order. button repeatedly, the result will be shown in a R e s u l t i D s p a y l 16 B P E C G S u d o t i 17 BP ECG Studio
(870E not applicable) System Requirements BP ECG Studio Installation Before installing BP ECG Studio, please check the system requirements listed below. Please use the companion CD to install BP ECG Studio. Operating System Recommended Hardware Windows 7 or higher Intel Core i3-3220 3.30 GHz or higher 1 GB of RAM or more 1 GB of hard disk free space or more Screen Resolution: 1280 x 1024 or higher Insert the CD to your computer. Browse the CD and double click Setup.exe to start the installation. B P E C G S u d o t i Select language and continue the process. Read and accept the license agreement. 18 B P E C G S u d o t i 19 BP ECG Studio Installation System Authentication Select the folder for installing BP ECG Studio. Click [Install] to start the installation process. The process of system authentication will be needed as BP ECG Studio is executed for the first time. Double click the icon to run BP ECG Studio. The following message will be displayed. Click [Finish] to complete the installation process. Then, the icon will be shown on the desktop. BP ECG Studio Connect the USB extension set with your device and plug it into the USB port of your computer. The system will automatically check the presence of your device. BP ECG Studio B P E C G S u d o t i 20 B P E C G S u d o t i 21 BP ECG Studio System Authentication Downloading ECG Data to Computer Click [OK] to complete the authentication process. Then, the main window of BP ECG Studio will be launched. To download ECG data to your computer:
Run BP ECG Studio. Create a new user account by clicking
.1 BP ECG Studio Fill in user information.2 Plug the connector of USB extension set into USB port of your computer. 1 You need to select a user account to log in every time. You may also delete the user account by clicking
. 2 The mandatory fields marked with CANNOT be changed once been set. B P E C G S u d o t i 22 B P E C G S u d o t i 23 BP ECG Studio Downloading ECG Data to Computer Main Window Make sure the connection is established. Click to enter data download. Disconnected Connected Click [ Download ] to download data from the device.1 Records will be added into Data List at the right column. Electrocardiogram Trace Grid Color Options Click to change the grid color into green or red. Scale Adjustment Zoom in
/ Zoom out Result Display
/ Reset the scale of signals. 1 If you want to delete the data after downloading, please select Delete data after download complete .Note: Please be aware that MD Biomedical will not be responsible for the loss of data and/or information in your computer. B P E C G S u d o t i 24 B P E C G S u d o t i 25 BP ECG Studio Main Window Data List Measurement Note Note your symptoms, Medications or activities related to the measurement for further reference. Multilingual Converter Click to change the interface to preferred languages. USB Connection Status Disconnected
/ Connected Functions Menu User information Download Edit the user information. Download data from the device to computer. Configure Configure your device. Print Print out the ECG/ BP data in a report format. Main Window Help About Open the on-line Instruction for Use of BP ECG Studio. Provide version and copyright information. Delete Delete the selected ECG data from computer. B P E C G S u d o t i 26 B P E C G S u d o t i 27 BP ECG Studio Configuration Configuration To configure your device, click to open the configuration window. In the configuration 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. Default By clicking [Default], you can reset your device to factory default settings. Device Information You can acquire the information of ID Number and Firmware Version. B P E C G S u d o t i 28 APP Download Cleaning and Maintenance System Requirements :
Smartphones or Tablets which support Bluetooth4.0 (BLE) A P P D o w n o a d l Please scan the QR code to enter APP introduction web page, and follow the instructions to download and use the APP. Note: Please be aware that MD Biomedical will not be responsible for the loss of data and/or information in your APP. 29 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. If electrodes are dirty, please use a soft cloth or a cotton swab moistened with 70~75% alcohol to clean the electrodes. Do not use alcohol to clean any other parts, and use it only to clean electrodes. Do not wash or immerse the device or other components in water. Do not use gasoline, thinners or similar solvents to clean the device or other components.
*Note: For best personal hygiene, please clean the device by following above instructions at least every 7 days after using. 30 M e s s a g e s 31 Messages Trouble Shooting Message Shown Possible Cause Suggestion Problem Possible Cause Suggestion The measurement result of averaged heart rate keeps flashing. Unstable or weak ECG signals. Please follow the instructions on page 11~14 to retake the measurement. The device cannot be turned on after pressing the power button for 3 seconds. 2. Batteries are installed with wrong direction. 1. Battery power is low. 1. Replace with new Measurement result shows EE. Failure analysis resulted from insufficient contact, an interruption, or high noise level during measurement. Please follow the instructions on page 11~14 to retake the measurement. batteries. 2. Please ensure the polarities of batteries are matched with the ones indicated on the battery compartment. Make sure to press the bottom electrodes with sufficient force. Press too lightly. The measurement does not start after the electrodes touching skin. Measurement records disappear from the device storage. Old records are overwritten by new ones due to storage overload. Download data periodically to your smartphones/tablets for records keeping. Message shows the system authentication failed while running the BP ECG Studio.(870E N/A) The device is not connected with the computer or the installation of BP ECG Studio failed. Make sure the device is well connected with the computer and restart the BP ECG Studio again. l T r o u b e S h o o t i n g 32 Vion. ECG Pen 880E / 870E Technical Specifications Model Vion ECG Pen Vion.880E/870E Induction System single channel, bipolar Bandwidth Sampling Rate 256Hz 0.05 ~ 40Hz Heart Rate Range 5 ~ 199 beats/min Memory 36 memory spaces Power Source two CR2032 coin-typed batteries Battery life 500+ measurements with 2 new coin-typed batteries Operation Temperature/Humidity/atmosp here Storage/Transport Temperature/Humidity Weight Dimensions 5 ~ 40C, 15~90% RH, 700hPa~1060hPa
-25~70, 90% RH, 700hPa~1060hPa 30g (without batteries) 93 mm x 38 mm x 10.5 mm Input signal range
-400mV < Signal (DC+AC) < 400mV Input Impedance
> 10M Ohms A/D resolution 16 bits Interface Service Life USB or Bluetooth 4.0 3 years (5 times per day) IP classification IP22 Protection against electric shock Internally powered ME equipment 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. If any cybersecurity vulnerability or incident is detected, please follow the suggestion of Messages and Trouble Shooting parts in the instruction manual first. If problem still exists, please contact MD biomedical for further processing and assistant. 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. could result in increased electromagnetic emission or decreased electromagnetic immunity of the device and result in improper operation.
*During measurement, the use of the device adjacent to or stacked with other device should be avoided because it could result in improper operation. In case such use is necessary, the device and other device should be observed to verify that they are operating normally.
*During measurement, Portable RF communications device (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by MD Biomedical, Inc Otherwise, degradation of the performance of the device could result.
*Refer to further guidance below regarding the EMC environment in which the device should be used.
+FCC Statement +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. FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
--Reorient or relocate the receiving antenna.
--Increase the separation between the equipment and receiver.
--Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
--Consult the dealer or an experienced radio/TV technician for help. Exposure to Radio Frequency Radiation:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meet FCC radio frequency(RF) Exposure Guidelines. This equipment must not be co-located or operating in conjunction with any other antenna or transmitter. 35 MD Biomedical, Inc. 8F., No.222, Sec 4, Chengde Rd., Taipei City 111, Taiwan www.mdbiomedical.com