Creative Medical PC-80B User Manual

Creative Medical PC-80B User Manual

Easy ecg monitor

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Easy ECG Monitor
PC-80B
User Manual
Shenzhen Creative Industry Co., Ltd

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  • Page 1 Easy ECG Monitor PC-80B User Manual Shenzhen Creative Industry Co., Ltd...
  • Page 2 User Manual for Easy ECG Monitor Instructions to User Dear Users, Thank you very much for purchasing our product. Please read the manual very carefully before using this device. These instructions describe the operating procedures to be followed strictly. Failure to follow these instructions may cause measuring abnormality, device damage, or personal injury.
  • Page 3 User Manual for Easy ECG Monitor Announcement Information furnished by the manufacturer is believed to be accurate and reliable. However, no responsibility is assumed by Creative for its use, or any infringements of patents or other rights of third parties that may result from its use. Declaration of Conformity: Creative hereby declares that this device complies with the following standards: IEC 60601-1...
  • Page 4 User Manual for Easy ECG Monitor WARNING 1. Check the device to make sure that there is no visible damage that may affect user’s safety and measurement performance. Stop using the unit, when there is obvious damage. 2. Do NOT make diagnosis oneself by the measurement and measurement results, always consult the doctor if abnormal information is presented frequently.
  • Page 5 User Manual for Easy ECG Monitor 7. The device is not equipped with detachable parts, the user should NOT take its shell apart without permission. 8. Connect/Disconnect data cable to the monitor gently and carefully, do NOT wring or shake the data cable plug with force to insert into or unplug from data interface port, or the data interface port may be damaged.
  • Page 6 User Manual for Easy ECG Monitor electrodes to ensure accurate measurement result. 14. When disposing of the device and its accessories, the local law should be followed. Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
  • Page 7: Table Of Contents

    User Manual for Easy ECG Monitor Table of Contents 1 OVERVIEW........................1 ......................1 1.1 A PPEARANCE ....................3 1.2 N AME AND ODEL ......................3 1.3 S TRUCTURE ........................ 3 1.4 F EATURES ......................4 1.5 I NTENDED ..................5 1.6 O PERATING NVIRONMENT 2 INSTALLATION......................5...
  • Page 8 User Manual for Easy ECG Monitor ........................47 3.7 H 4 TECHNICAL SPECIFICATIONS ..................48 ..................... 48 4.1 ECG M EASUREMENT ......................... 49 4.2 P OWER ..................... 49 4.3 C LASSIFICATION ........................ 50 4.4 D ISPLAY ...................... 50 4.5 D EMORY ................
  • Page 9: Overview

    User Manual for Easy ECG Monitor 1 Overview 1.1 Appearance...
  • Page 10 User Manual for Easy ECG Monitor Power: Long time press (about 2 seconds) to power on or off the device; short time press turns on/off the backlight. 2. Metal Electrode I, II Measurement: shortcut button for measuring, press this button to start measuring.
  • Page 11: Name And Model

    1.2 Name and Model Name: Easy ECG Monitor Model: PC-80B 1.3 Structure PC-80B Easy ECG Monitor consists of main board, panels and electrodes. 1.4 Features 1. Small in size, light in weight and easy to carry. 2. One-key measurement, easy to operate.
  • Page 12: Intended Use

    9. Wireless data upload function (optional). 1.5 Intended Use PC-80B Easy ECG Monitor is intended for measuring and recording the ECG signal and average heart rate of adult patient. It is applicable for use in clinics and homes, and convenient to operate by the patients themselves.
  • Page 13: Operating Environment

    User Manual for Easy ECG Monitor 1.6 Operating Environment Operating temperature: 5~40℃ Operating humidity: 30%~80% Atmospheric pressure: 70~106kPa 2 Installation 2.1 Installation of Batteries 1. Open the battery cover (see the Figure 2-1). 2. Insert two AAA size batteries directly. 3.
  • Page 14: Operation

    User Manual for Easy ECG Monitor 3 Operation 3.1 Start to measure ECG Press the Power button (lasting for 2 seconds) to turn on the unit. The unit starts to initialize, and displays the following pictures Figure 3-1A and Figure 3-1B. Figure 3-1A...
  • Page 15 User Manual for Easy ECG Monitor Figure 3-1B After boot-strap, the unit enters menu screen, as shown in Figure 3-2. Note: During initialization, press “ Return” button to enter main menu screen, as shown in Figure 3-2. If press “ Measurement”, it will enter measuring screen, as shown in Figure 3-4.
  • Page 16 User Manual for Easy ECG Monitor There are 6 tool buttons, press navigation key to shift cursor and press “ OK” to confirm. Each functional button will be defined as follows: Measure: detect ECG waveform and HR value, and analyze whether the ECG waveform is normal.
  • Page 17 User Manual for Easy ECG Monitor Memory: check the storage space and delete the ECG records saved in this device. Setting: set parameters such as date, time, language, beeper, filter mode, brightness and wireless etc. Help: provide the user with measuring methods etc. information. 中...
  • Page 18: Ecg Measuring Method

    User Manual for Easy ECG Monitor 3.2 ECG Measuring Method 3.2.1 Quick and Short ECG Measurement 1 Chest Measurement In order to obtain ideal ECG signal, chest measurement is the first recommended method for it can ensure stable signal and fewer interference.
  • Page 19 User Manual for Easy ECG Monitor electrode on clothing.) 2 Leg Measurement convenient adopt chest measurement, the leg measurement will be recommended. When measuring, hold the device with the right hand. Make sure that the palm and fingers touch the metal electrode I and II reliably. Place the electrode III on the skin 10cm above the left foot ankle.
  • Page 20 User Manual for Easy ECG Monitor 3 Palm Measurement Palm Measurement is recommended in terms of convenient and quick measurement. Hold the device with right hand. Make sure that the palm and fingers touch the metal electrode I and II reliably. Press the electrode III closely against the center of the left palm.
  • Page 21 User Manual for Easy ECG Monitor 3.2.2 Continuous or Long-term ECG measurement 1 Lead Wire Measurement To obtain clear and high quality ECG signal, the lead wire measurement can be used. Connect the lead wire firmly to the lead wire socket of the device Place the electrodes and connect the lead wires as Figure3-3D to obtain the Lead II ECG signal;...
  • Page 22 User Manual for Easy ECG Monitor Electrode Lead Lead I Lead II Lead III Name Electrode Location The intersection between the centerline R/RA R/RA L/LA of the right clavicle and Rib 2. The intersection between the centerline F/LL L/LA R/RA of the left clavicle and Rib 2.
  • Page 23: Ecg Measuring Procedure

    User Manual for Easy ECG Monitor 3.3 ECG Measuring Procedure 3.3.1 Quick Measurement After choosing proper measuring method as described in Chapter 3.2.1, press “ Measure” to enter quick ECG measurement automatically, shown in Figure 3-4. The first 15 seconds is preparing phase during which device will...
  • Page 24 User Manual for Easy ECG Monitor 1. “16: 14: 32”: Current time.  2. “X1”: ECG waveform gain.  “X1/2”: Waveform scaled with half of the basic gain; “X1”: Waveform scaled with basic gain; “X2”: Waveform scaled with twice of the basic gain “X3”: Waveform scaled with three times of the basic gain 3.
  • Page 25 User Manual for Easy ECG Monitor 9. “ ”: Wireless mark (optional). When the “Wireless” is set as “ON” status  in system setting screen, this mark will display on the screen. After a successful connection between the device and the remote host, the ECG data can be uploaded to the host (PC) for further recall, analysis and storage.
  • Page 26 User Manual for Easy ECG Monitor “ Return”: return to main menu screen directly and the current measurement result and measuring value won’t be saved. “Save”: save the current measurement result and measuring value. 3. In the measurement result screen, the current measurement data will be saved in this device automatically without any operation in 6 seconds or directly press the “...
  • Page 27 User Manual for Easy ECG Monitor transmitted and saved to PC. After that the device will return to the main screen automatically. (Refer to User Manual for “ECG Viewer Manager” for detailed operation procedure) 3.3.2 Continuous Measurement 1. After choosing the continuous measuring method as described in Chapter 3.2.2, press the “...
  • Page 28 User Manual for Easy ECG Monitor selected and a successful connection is setup, click the “Wireless Receive” icon on the host side while running software “ECG Viewer Manager” on PC so the data record can be transmitted and saved to PC (Refer to User Manual for “ECG Viewer Manager”...
  • Page 29 User Manual for Easy ECG Monitor Figure 3-9 Figure 3-10 3)The device provides built-in 16MB/32MB memory clips (selecting “Memory” on main menu screen to see the detailed memory space), at most 1200/2700 data records quick measurement 10-hour/22.5-hour data records for continuous measurement can be saved in this device, and when the device connects to PC successfully, it works as a removable USB disk which contains four files, and 300/720 pieces of quick measurement can be recorded in each file.
  • Page 30: Wave Review

    User Manual for Easy ECG Monitor “Memory full! Overwrite record?” with a display of “ ” mark as shown in Figure 3-10. Meanwhile, from now on, it won’t store the new record until the user manually deletes the unnecessary data or upload the records to PC to free some memory.
  • Page 31 User Manual for Easy ECG Monitor “ ”: If the enhanced mode is used, the icon of enhanced mode will be shown behind the record. Figure 3-11 Record List NOTE: There is no such legend icon display for the record of continuous measurement.
  • Page 32 User Manual for Easy ECG Monitor 2. Choose a record in record list, then press “  OK” button to review this ECG record, the waveform display for quick measurement and continuous measurement are shown in Figure 3-12 and Figure 3-13 respectively. To stop auto replay, just press the Navigation key “/”...
  • Page 33 User Manual for Easy ECG Monitor Figure 3-13 ECG Data Review Screen (Continuous Measurement) On-screen display: 1. “16: 14: 32”: ECG waveform measuring time.  2. “X1”: ECG waveform gain. There are 4 options available:  “X1/2”: Waveform scaled with half of the basic gain; “X1”: Waveform scaled with basic gain;...
  • Page 34 User Manual for Easy ECG Monitor “X2”: Waveform scaled with twice of the basic gain; “X3”: Waveform scaled with three times of the basic gain. 3. “HR=66”: heart rate value is 66bpm. For waveform review of continuous  measurement, the heart rate value won’t be displayed. “1/2”: the screen page description for waveform review of continuous measurement.
  • Page 35 User Manual for Easy ECG Monitor ② ECG waveform miniature in selecting box is the ECG waveform measured in 30 seconds. 3. Press “ OK” button again, the measurement result of the selected record will be reviewed on the screen, as shown in Figure 3-14. Figure 3-14 Figure 3-15 (1) “...
  • Page 36 User Manual for Easy ECG Monitor Send” button on the device, then on the host side, click the “Wireless Receive” icon while running the software “ECG Viewer Manager” on PC, the data will be transmitted and saved on PC. 4. Select “YES”, then press “ OK” button to perform deletion and return to record list screen.
  • Page 37 User Manual for Easy ECG Monitor Figure 3-16 Figure 3-17 NOTE: Figure 3-16 and Figure 3-17 show the measurement results by continuous measuring method. The measurement by result continuous measuring method is shown on the left. If one screen hasn’t enough space to show all the measurement results, the user can press Navigation Key “/”...
  • Page 38 User Manual for Easy ECG Monitor 3.4.3 Measurement Result Table Measurement Result Waveform Descriptions No irregularity found...
  • Page 39 User Manual for Easy ECG Monitor Suspected a little fast beat Suspected fast beat Suspected short run of fast beat Suspected a little slow beat Suspected slow beat Suspected occasional short beat interval...
  • Page 40 User Manual for Easy ECG Monitor Suspected irregular beat interval Suspected fast beat with short beat interval Suspected slow beat with short beat interval 11 Suspected slow beat with irregular beat interval 12 Waveform baseline wander 13 Suspected fast beat with baseline wander...
  • Page 41: Data Management

    User Manual for Easy ECG Monitor 14 Suspected slow beat with baseline wander Suspected occasional short beat interval with baseline wander Suspected irregular beat interval with baseline wander Poor Signal, measure again Table 3-1 3.5 Data Management 3.5.1 Data Deletion Select “Memory”...
  • Page 42 User Manual for Easy ECG Monitor Figure 3-18 Memory Screen Note: the used space plus the unused space equals to the total memory size (16MB/32MB). “ Return”: press “ Return” button to return to main screen. “ Delete”: press this key to delete all the records. Prior to deletion, a dialogue box “Sure to delete all?”...
  • Page 43 User Manual for Easy ECG Monitor Figure 3-19 Figure 3-20 Records Deleting Note: The operation of data deletion carried out in the memory screen means all the data in the device will be deleted; if you only want to delete one record, please do that on waveform review screen.
  • Page 44 User Manual for Easy ECG Monitor 3.5.2 Upload Data Connect the device to PC with USB data cable, the device will automatically enter the upload display as shown in Figure 3-21. The data can be dumped to PC for data management, review and analysis.
  • Page 45: System Setting

    User Manual for Easy ECG Monitor 3.6 System Setting On the main menu screen, select “Setting”, then press “  OK” button to enter system setting screen, as shown in Figure 3-22 and Figure 3-23 Figure 3-22 Figure 3-23...
  • Page 46 User Manual for Easy ECG Monitor 3.6.1 Time/Date Setting 1.On system setting screen, select “Time/date” with Navigation Key, then press “ OK” button to enter time and date setting screen (date format: dd/mm/yyyy), as shown in Figure 3-24. 2. Use Navigation Key to adjust the value, and then press “  OK” button to shift black cursor and adjust another value.
  • Page 47 User Manual for Easy ECG Monitor 3.6.2 Language Setting 1. On system setting screen, select “Language” to enter language information screen, as shown in Figure 3-25. 2. Press the Navigation Key to select the language between “ 简 体 中 文 ” and “English”.
  • Page 48 User Manual for Easy ECG Monitor 3.6.3 Brightness Setting 1. On system setting screen, select “Brightness” to enter brightness setting screen, as shown in Figure 3-26. 2. Adjust brightness with Navigation Key; 1~7 level adjustable; 3. Press “ OK” button to save setting and return to the upper level menu screen. Figure 3-26 Brightness Setting...
  • Page 49 User Manual for Easy ECG Monitor 3.6.4 Beeper Setting 1. On system setting screen, select “Beeper” to enter beeper setting screen, as shown in Figure 3-27. 2. Choose “ON” or “OFF” with Navigation Key to turn on the beeper or turn off the beeper;...
  • Page 50 User Manual for Easy ECG Monitor 3.6.5 Measure Mode Setting 1. On system setting screen, select “Measure mode” to enter measure mode setting screen, as shown in Figure 3-28. 2. Choose “Normal” mode or “Enhanced” mode with Navigation Key. The default setting is “Normal”...
  • Page 51 User Manual for Easy ECG Monitor 3.6.6 Wireless Setting 1. On system setting screen, select “Wireless” to enter wireless setting screen, as shown in Figure 3-29. 2. Press the Navigation Key to turn on or turn off the wireless function. 3.
  • Page 52 User Manual for Easy ECG Monitor Downloading the APP software for smart phone  The terminal devices such as smart phone can be used to receive data from the Easy ECG Monitor in real-time, and store the received data, review the stored data as well.
  • Page 53 User Manual for Easy ECG Monitor software "PC-80B. apk" will be displayed on the smart phone. 4. Open this web link by a web browser to download the APP software "PC-80B.apk". Install this APP software if successful downloaded. For terminal devices with the iOS system (such as iPhone, iPad), please follow this procedure to download: 1.
  • Page 54 User Manual for Easy ECG Monitor http://www.creative-sz.com/software/ 3.6.7 Resume Default 1. On system setting screen, select “Default setting” to enter into default setting screen, as shown in Figure 3-29. 2. Choose “YES” or “NO” with Navigation Key. If the choice is “YES”, then press “ OK”...
  • Page 55: Help

    User Manual for Easy ECG Monitor 3.6.8 Version Info On system setting screen, select “Version” to enter version information screen, as shown in Figure 3-30. “V52-10-10” is version number(refer to the actual version). Figure 3-31 Version Information 3.7 Help On main menu screen, select “Help”, then press “ OK” button to enter help info screen.
  • Page 56: Technical Specifications

    User Manual for Easy ECG Monitor 4 Technical Specifications 4.1 ECG Measurement 1. The number of measuring channel: Single channel ECG signal. 2. Electrodes: 3 embedded metal electrodes or 3 adhesive ECG electrodes connected to the connector of the device with lead wire. 3.
  • Page 57: Power

    User Manual for Easy ECG Monitor 8. Display scale: 5.0mm/mV±10% 9. Common-mode rejection ratio (CMRR): ≥60dB 10. Waveform sweeping speed: 20mm/s±10% 11. Input loop current: ≤0.1μA 12. Input impedance: ≥5 MΩ 4.2 Power Power: 2×AAA alkaline batteries Supply voltage range: 2.7~3.3VDC Max average working current: ≤50mA Auto power-off: 35s±5s (without operation) Low battery indication: 2.5VDC±0.2VDC...
  • Page 58: Display

    User Manual for Easy ECG Monitor 3. The degree of protection against harmful ingress of liquid: Ordinary equipment without protection against ingress of liquid. 4. Electro-magnetic Compatibility: Group I, Class B 4.4 Display 1. LCD type: colour LCD 2. Display area: 57.6mm × 40mm 4.5 Data Memory 1.
  • Page 59: Accessories

    User Manual for Easy ECG Monitor 5 Accessories A hanging cord Two batteries (AAA) A Pouch A User Manual A data cable (optional) An ECG lead wire (optional) Note: The accessories are subject to change. Please see the Packing List for detailed items and quantity.
  • Page 60: Maintenance And Service

    User Manual for Easy ECG Monitor 6 Maintenance and Service 6.1 Maintenance The life of this device is 5 years. In order to ensure its long service life, please pay attention to the maintenance. 1. Please change the batteries, when appears low-voltage icon. 2.
  • Page 61: Cleaning And Disinfecting Instruction

    User Manual for Easy ECG Monitor Notes Keep it away from corrosive substances, explosive substances, high/low  temperature and moisture. If the device gets wet or has water steam, please stop operating it.  When it is taken from cold environment to warm and humid environment, ...
  • Page 62: Troubleshooting

    User Manual for Easy ECG Monitor 7 Troubleshooting Trouble The device can not turn on. Possible Reason Solution 1. The batteries are drained or almost drained. 1. Change batteries. 2. The batteries are not inserted 2. Reinstall batteries. properly. 3. Please contact the local service center. 3.
  • Page 63 User Manual for Easy ECG Monitor Trouble The device is failure in measuring heart rate. Possible Reason Solution 1. Electrode does not contact 1. Place the electrode correctly. body well. 2. When measuring, please keep quiet 2. Movement when measuring. and avoid moving.
  • Page 64 User Manual for Easy ECG Monitor Trouble ECG waveform excursion, strong irrelevant waveform or the ECG waveform displays on the screen, but the prompt info is “Contact?”; Possible Reason Solution 1. Clean skin with soap and water and 1. Skin is dry or oily. eliminate skin crumb and grease to make the 2.
  • Page 65: Error Message And Solutions

    User Manual for Easy ECG Monitor 8 Error Message and Solutions Error Reason Solution 1. Press the “Return” button to exit from Communication The communication error interfered current status abnormal 2. Ensure the PC software can operate normally. 3. Restart the wireless function or the device.
  • Page 66 User Manual for Easy ECG Monitor 9 Key of Symbols Symbol Description Symbol Description Heart Rate Battery indicator (Unit: beats per minutes) Measure mode: enhanced Wireless transmission mark Full memory mark Return button Confirmation button ▇ Power button Navigation key /...
  • Page 67: Appendix

    User Manual for Easy ECG Monitor Manufacturer USB data cable interface (including address and date) Authorised representative in Disposal of this device the European community according WEEE regulation. Note: The symbols “ ”, “ ”, “ ”, “ ” and “ “are displayed on the screen, the others are marked on the device panel.
  • Page 68 User Manual for Easy ECG Monitor QRS wave: 0.06~0.10s; No ectopic ECG activity. Symptom: Sinus rhythm, heart rate: 60~100bpm Indication: Normal Ⅱ Several abnormal ECG waveforms 1) Tachycardia: The heartbeat becomes faster. Tachycardia is determined by the rhythm of the heart, the average rhythm beats faster than 100 times a minute is considered as Tachycardia.
  • Page 69 User Manual for Easy ECG Monitor fever, influence of some medication (such as atropine, epinephrine etc.). Suggestion: If it belongs to pathology condition, please go to hospital. 2) Bradycardia: The heartbeat becomes more slowly. It is determined by the rhythm of the heart, the average rhythm is less than 60 beats per minute is considered as Bradycardia.
  • Page 70 User Manual for Easy ECG Monitor Suggestion: If it belongs to the pathology condition, please see the doctor. 3) Premature beat: In a normal beat a QRS waveform appears prematurely and is followed by a comeback pause. The result description “Suspected occasional short beat interval”...
  • Page 71 User Manual for Easy ECG Monitor Symptom: The heart beat is arrhythmic, it occurs as the phenomenon that the heart suddenly beats and then stops for a while. Some people have palpitation or have no symptom. Indication: The premature beat can be found occasionally in healthy people, with no distinct symptom or sometimes with palpitation.
  • Page 72 User Manual for Easy ECG Monitor 4) Bigeminy: It is a type of PVC in which a normal beat is coupled with a premature beat. Indication: PVC occurs frequently. Suggestion: Please see the doctor. Figure 5 Bigeminy...
  • Page 73 User Manual for Easy ECG Monitor 5) Trigeminy: It is a type of PVC in which two normal beats are coupled with a premature beat. Indication: PVC occurs frequently. Suggestion: Please see the doctor. Figure 6 Trigeminy The result description “Suspected irregular beat interval” in this device may be doubted as Bigeminy or Trigeminy.
  • Page 74 User Manual for Easy ECG Monitor According to the different of active original position, it can be divided into:Short Run, SVE Short Run (Needing professional to judge). 1)Short Run : It is caused by Premature Atrial Contraction or Nodal Premature Beat, frequency>180bpm.
  • Page 76 Shenzhen Creative Industry Co.,Ltd. Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China Tel: +86-755-2643 3514 Fax: +86-755-2643 0930 E-mail: info@creative-sz.com Website: www.creactive-sz.com Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg Germany...

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