QT Medical QTERD100 QT ECG User Manual Manual

QT Medical INC. QT ECG Manual

Manual

QT ECG USER’S MANUAL IMPORTANT WARNINGS ●Federal law restricts sale of this device by or on the order of a physician. ●This device is not defibrillator-proof. ●MR Unsafe! Do not expose the device to a magnetic resonance (MR)                       environment. ●Do not try to charge the QT ECG Recorder while it is connected to the Electrode                               Strip. ●Do not place the Electrode Strip on yourself. Ask someone else to help you. ●Both you and the person helping you need to read this manual thoroughly                         before using the QT ECG. For your safety, follow the operating instructions and                         all safety measures, including warnings and cautions, listed in this manual to                       ensure safe and reliable performance of the system.  ●The Electrode Strip is for one-time use only. Do not reuse. To prevent potential                           transmission of infection or disease, dispose the Electrode Strip properly after                     each use. Contact local authorities for proper disposal method of potentially                     bio-hazardous materials.  ●Always use the latest version of the QT ECG App.
  1. INTRODUCTION This user manual provides information on the QT ECG system and instructions on                         how to use it.   1.1 System Description The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG)                     system with Bluetooth connectivity. The QT ECG system consists of 3 major                       components:  ●The QT ECG Recorder – Compact device that records 12-lead, resting                     electrocardiograms, then transmits the recorded data to a mobile device                   (smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile                 device (not included) is needed to operate the QT ECG Recorder, and to send                           the recoded rhythm strip to a cardiologist or licensed physician for review. ●The QT Electrode Strip – Disposable, patented electrodes that are                   prepositioned on a self-adhesive strip  ●The QT ECG App – Software that lets you use your mobile device to operate the                               QT ECG recorder, then send the recorded data via email to a certified medical                           professional for review.  Note: To use the QT ECG system, you will need to have a Bluetooth- enabled                             mobile device.  Warning: Use only manufacturer-approved accessories with the QT ECG. Warning: The QT ECG is not intended for treatment or monitoring. It captures                         data that reflect the patient’s physiological condition. The data must be reviewed                       and analyzed by a cardiologist or trained physician before a diagnosis is made.   1.2 Indication for Use The QT ECG System is intended to acquire, record and process an                       electrocardiographic signal so that it can be transmitted digitally via Bluetooth                     technology to a cell-phone or mobile device, then to a remote location. The QT                           ECG System is indicated for use on adult patients and pediatric patients age 18                           2
  – 22 years. It is designed to be used by a patient or other layperson in the                                 home, or by healthcare workers in non-acute care clinical facilities (such as                       nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG                       and rhythm strip in real-time to enable review at a physician's office, hospital                         or other medical receiving centers. 1.3 Intended Use The QT ECG System is intended for use on adult patients and pediatric patients                           age 18 – 22 years to acquire ECG signals so that it can be transmitted wirelessly                               via Bluetooth to a cell-phone or mobile device, then to a remote location. The                           QT ECG System is designed to be used by a patient to record ECG data and                               transmit to a physician’s office, hospital or other medical receiving center for                       review 1.4 Contraindications There are no known contraindications. 1.5 Environment The QT ECG system is designed for home use and for use in non-clinical settings. No                               professional medical training is required to use this system.   1.6 Symbols The following symbols are used in this manual and in the product:  The QT ECG Recorder Symbol/Marking Description  FCC Declaration of Conformity mark.         Certification mark employed on       electronic products manufactured or       sold in the United States which           certifies that the electromagnetic       interference from the device is under           limits approved by the Federal         Communications Commission. 3
   NCC Declaration of Conformity mark.         Certification mark employed on       electronic products manufactured or       sold in the Republic of China (Taiwan)             which certifies that the       electromagnetic interference from     the device is under limits approved           by the NCC.  The WEEE symbol, indicating       separate collection for WEEE- Waste         of Electrical and Electronic       Equipment, consists of the       crossed-out wheeled bin.  Bluetooth wireless technology     incorporated  Non-ionizing radiation Model Number: QTERD100 The QT ECG Recorder reference         number. FCC ID: 2AIBAQTERD100 Contains FCC ID: SSSBC127-X FCC ID is a unique identifier assigned             to a device registered with the           United States Federal     Communications Commission.  IC: 21780-QTERD100 Contains IC: 11012A-BC127 IC ID is the product ID assigned by               Industry Canada to identify wireless         products in the Canadian market.  4
   “REFER TO MANUAL”: Follow       operating instructions  “MR-unsafe”: Do not expose the device           to a magnetic resonance (MR)         environment.  The degree of protection provided by           the enclosure from particulate       matter and water. 2represents that protection against         object sized >12.5mm (Fingers or         similar objects) 2represents that the enclosure has a            protection level of “water jet;”.         Vertically dripping water shall have         no harmful effect when the enclosure           is tilted at an angle up to 15° from its                   normal position.  “MANUFACTURER”: The name and       the address of the manufacturer. 5
   UDI data matrix barcode is intended           to assign a unique identifier to           medical devices within the United         States.   Caution: Federal law restricts this         device to sale by or on the order of a                   licensed medical practitioner.  Type CF is the most stringent           classification, being required for       those applications where the applied         part is in direct conductive contact           with the heart or other applications           as considered necessary.  Storage and transportation     conditions: humidity range  Storage and transportation     conditions: pressure range  Storage and transportation     conditions: temperature range  “CATALOGUE NUMBER”: The     catalogue number of product. 6
   "BATCH CODE": The manufacturer's       batch code.  "SERIAL NUMBER": The     manufacturer's serial number.  The packing date of QT ECG ECG             Recorder.  Rated direct current input supply         voltage and current.  Press and hold for 5 second to on/off               the QT ECG Recorder. PWR The PWR LED indicates the power           and charging status. CON The CON LED indicates the         connecting status of the QT ECG ECG             Recorder to the mobile computing         device. REC The REC LED indicates the recording           status of the recorder. Electrode Strip 7
   Do not reuse  Do not use if package is damaged  General warning sign  Type CF is the most stringent           classification, being required for       those applications where the applied         part is in direct conductive contact           with the heart or other applications           as considered necessary.  Keep away from sunlight 8
   Storage and transportation     Temperature Limit  Storage and transportation     conditions: humidity range  Storage and transportation     conditions: pressure range  Date of manufacture  “CATALOGUE NUMBER”: The     catalogue number of product.  "BATCH CODE": The manufacturer's       batch code.  2. SAFETY INFORMATION Make sure you are familiar with the safety information in this section before using 9
  the QT ECG. Pay attention to all warnings and cautions to avoid personal injury and/or equipment damage. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in personal injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in damage to the equipment or other property.   2.1 Operating the Device 2.1.1 Warnings 2.1.1.1 Inspection: Visually inspect the QT ECG and all accessories prior to                     use. Do not use if any components are damaged. 2.1.1.2 Do not use high voltage device such as AED (Automated External                     Defibrillator) when using Electrode Strip. Please remove the QT                 ECG before using high voltage device on the individual. High                   voltage device will damage the Electrode Strip and the QT ECG                     Recorder if they are used at the same time. 2.1.1.3 No modification of this equipment is allowed. 2.1.1.4 Never attempt to connect the QT ECG Recorder and its                   accessories to any other device. Always follow the User Manual                   instructions for safe and reliable performance. Only connect the                 QT ECG Recorder with approved accessories to the device. 2.1.1.5 Never use the conductive parts of the Electrode Strip to contact                     any other conductive objects, including the earth. 2.1.1.6 Keep the device away from flammables, such as, nitrous oxide and                     anesthetic mixtures with oxygen and air. 2.1.1.7 To prevent potential transmission of infection or disease, the                 one-time use Electrode Strip must be properly disposed of after                   each use. The QT ECG Recorder may be cleaned before usage.                     10
  Please refer to the section “Preventive Maintenance” to find                 information about cleaning methods. 2.1.1.8 The QT ECG is not designed for use with high voltages or surgical                         equipment. To ensure the safety of the operator and the                   individual having the test, disconnect the device and all                 components prior to any procedure. 2.1.1.9 The Electrode Strip may damage the skin if removed too quickly or                       carelessly. 2.1.1.10 The Electrode Strip is for one-time use only. Do not reuse. 2.1.1.11 Do not place the Electrode Strip yourself. Ask someone else for                     help when applying the Electrode Strip. 2.1.1.12 Once the data has been collected, remove the Electrode Strip                   right away. Prolonged use of the Electrode Strip could cause                   allergic reaction or skin irritation. Contact your doctor if skin                   reaction persists. 2.1.1.13 To avoid strangulation and suffocation, use under adult               supervision. 2.1.1.14 The summation of electrical current leakage when a QT ECG                   Recorder and a Electrode Strip are in use and interconnected is at                       most 50 uA. 2.1.1.15 Remove the device if it causes discomfort. 2.1.1.16 The use of applied part (Electrode Strip) is not intended for                     intracardiac use or direct cardiac application. It should not come                   in direct contact with the heart. 2.1.1.17 Use of the QT ECG adjacent to or stacked with other equipment                       should be avoided because it could result in improper operation                   or high current leakage. If such use is necessary, the QT ECG and                         11
  the other equipment should be observed to verify that they are                     operating normally. 2.1.1.18 Use of accessories or Electrode Strip other than those specified or                     provided by QT Medical of the QT ECG could result in increased                       electromagnetic emissions or decreased electromagnetic         protection of the QT ECG and lead to improper functions. 2.1.1.19 Portable RF communication equipment (including peripherals           such as antenna cables and external antennas) should be used no                     closer than 30 cm (12 inches) to any part of the QT ECG including                           Electrode Strip. Otherwise, degradation of the performance of the                 QT ECG could result. 2.1.2 Cautions 2.1.2.1 Only use the device in environments described in the User                   Manual. Avoid presence of equipment with electromagnetic             interference such as microwave ovens, radios, televisions, etc.               The electromagnetic interference can degrade the performance of               the device. 2.1.2.2 If the QT ECG is used in an environment with ESD (ElectroStatic                       Discharge), the ESD signal may interfere with ECG signals. Try to                     avoid this kind of environment. 2.1.2.3 Do not take apart the device or alter any component. For                     technical assistance please contact QT Medical.  2.1.2.4 For cybersecurity purposes, user should run regular virus checks                 on the mobile device. 2.1.2.5 Only use the QT ECG with compatible firmware as specified in the                       User Manual. 2.1.2.6 Follow the User Manual when connecting the device to its                   components. Assure all accessories and device are properly               connected. 2.1.2.7 Cleaning the device incorrectly or exposure to cleanser and                 12
  disinfectant can damage the device. Please follow the cleaning                 instructions carefully. 2.1.2.8 Do not use non-recommended cleaning or disinfection solutions               with the QT ECG Recorder and its accessories. Please follow the                     cleaning instructions carefully. 2.1.2.9 Do not attempt to autoclave or sterilize the QT ECG Recorder and                       its accessories. 2.1.2.10 Do not attempt to charge the QT ECG Recorder when it is                       connected to the Electrode Strip. 2.1.2.11 The Electrode Strip should be applied only to intact, clean skin                     (e.g., not over open wounds, lesions, infected, or inflamed areas). 2.1.2.12 Avoid using the QT ECG when it is in the presence of equipment                         with known electromagnetic interference, such as MRI, CT, and                 ultrasound machines. Such equipment may affect the quality of                 signals recorded by the QT ECG. A list of advice to avoid or                         minimize the interference is noted in the Appendix. 2.1.2.13 Do not open the Electrode Strip package until time of use. If not                         stored properly, the Electrode Strip might dry out, which can                   result in poor conductivity and poor quality data. 2.1.2.14 Once the Electrode Strip package is opened, use it as soon as                       possible. Keep it away from lint and dust, which may result in                       poor conductivity and poor quality data. Keep it away from                   children and pets to avoid damage. 2.1.2.15 Keep the device away from exposure to direct sunlight. 2.1.2.16 Follow storage condition instructions as described in the User                 Manual. Make sure the storage environment is appropriate. 2.1.2.17 If necessary, contact local authorities to determine the proper                 method of disposal for potentially biohazardous parts and               accessories. 2.2 Note 13
  2.2.1 Federal law restricts sale of this device by or on the order of a physician. 2.2.2 The device does not require calibration. 2.2.3 The QT ECG is not intended for treatment or monitoring. It captures data                         that reflect the patient’s physiological condition. The data can be shared                     with the patient after it has been reviewed and analyzed by a cardiologist                         or trained physician. 2.2.4 Always use the latest version of the QT ECG App 2.2.5 Before placing the Electrode Strip on the patient’s chest, locate the                     landmarks on the chest as described in the User Manual or quick guide. A                           misplaced Electrode Strip can lead to inaccurate results. 2.2.6 When necessary, properly dispose of the Electrode Strip after use in                     compliance with local regulations. 2.2.7 The ECG data displayed on the mobile device is 500 Hz. A computer or                           server based diagnostic report, can display up to 1000 Hz should the                       physician need higher resolution data. 2.2.8 Patients should remain as still as possible when collecting ECG data.                     Excessive patient movement can lead to poor quality data. 2.2.9 For optimal data collection, the patient’s skin should be free of oil and/or                         lotions before placing the Electrode Strip on the chest. 2.2.10 Please charge the device fully before the first use. 2.2.11 The Electrode Strip should only be used in consultation with QT Medical,                       Inc. or a health care provider familiar with its proper placement and use. 2.2.12 The Electrode Strip should be replaced if the adhesive patches can no                       longer attach firmly to the skin. 2.2.13 Please consult your healthcare provider for assistance with choosing the                   proper Electrode Strip size and fit. The Electrode Strip is designed to fit                         adult, pediatric and newborn patients. 14
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  3. PRIOR TO OPERATION 3.1 Know your Unit Your package contains the following items: A. QT ECG Recorder B. Quick Guide C. Wall Charger                                 16
    The Electrode Strip is packaged and sold separately  17
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     3.1.1 QT ECG Recorder (Main Device) The three-view diagram of the QT ECG Recorder is shown in Fig 3.1.1a To                           turn on/off the QT ECG Recorder, press and hold the power button for 5                           seconds. The Power (PWR) LED indicator will turn solid green when the                       power is on. The QT ECG Recorder has two ports; one is used to connect                             with the Electrode Strip, and the other is used for charging with a Micro                           USB wall charger (Fig 3.1.1b & Fig 3.1.1c). Do not attempt to charge and                           plug-in the Electrode Strip at the same time. Do not use any charger                         other than the one provided in the original case. Do not attempt to                         connect the QT ECG Recorder with any other cable, connector or power                       cord because such practice can damage the QT ECG Recorder. There are three LED indicators; PWR, CON and REC which indicate the                       device status.  19
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   Fig 3.1.1c  A. Power Button: To turn on/off the QT ECG Recorder, press and hold the power button for 5 seconds. The Power (PWR) LED indicator will turn solid green when the power is on. B. Micro USB Port: Used for charging the QT ECG Recorder with the wall charger  C. Recorder Receptacle: Used to connect with the Electrode Strip D. LED Indicators  Table 3.1.1a Specification of the QT ECG Recorder LED Indicators     PWR(RGB) CON(BLUE) REC(Amber) ON Green: Power on or Charging complete Softe white: charging BLE connected No information OFF Power off No information No information Blink Green: Low Battery < 10% BLE disconnected/Advertising Record ongoing Fast Blink Red: System error No information No information  Table 3.1.1b Specification of the QT ECG Recorder Feature Specification 22
  Brand Name QT ECG Model Number QTERD100 Dimension 72.00x68.02x18.60 mm (2.83 x 2.68 x 0.735 in) Weight 85 g Enclosure Material Polycarbonate Wireless Technology Bluetooth 4.0 dual mode Operation frequency range: 2.402 GHz <-> 2.480 GHz (BLE); 2,402MHz to 2,480 MHz (BT) LED PWR: Power/Status LED (RGB) CON: Connection LED (Blue) REC: Recording LED (Amber) External Port Micro USB port of the recorder (charging port) Recorder Receptacle (connect with the Electrode Strip) Physical Button Power On/Off switch Battery Rechargeable lithium-ion polymer battery, 3.7 V, 700 mAh 23
  Battery Charge Time 1.5 hours Battery Operating Time 17 hours of continuous use 24 hours of normal use (use: standby = 1:5)  with new battery Battery Charging Procedure Connect the QT ECG Recorder to wall charger through the Micro USB port of the recorder Battery Replacement Irreplaceable Charging Indicator Solid white Low Battery Indicator Blinking green Service Life Battery: ≥ 300 cycle The QT ECG Recorder: 5 years Signal Sampling Rate 1000 Hz Channel Skew 0 Acquisition Mode Simultaneous sampling approach for each channel A/D Resolution 24-bit Quantization Error 0.047 uV/LSB Frequency Response 0.05 to 150 Hz 24
  Triangle Response 6% maximum reduction 20 ms vs 200 ms triangle wave Filters Default off. Input Impedance 6.875 MΩ DC-offset Voltage +/- 399 mV Multichannel Crosstalk ≤15 uV CMRR 97 dB Noise Level ≤10 uV Overload Tolerance Up to 1 V Wireless Distance 20-30 m Bluetooth Transmission Rate 3 Mbps Standard Leads Acquired I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Sensitivity 5, 10, 20 mm/mV auto (I~aVF: 10 mm/mV, V1~V6: 5 mm/mV) Calibration Automatic Data Storage In mobile device Lead-off Detection Yes 25
  Pacemaker Detection Yes Operating Temperature 5~40°C; 41~104ºF Operating Relative Humidity 15% – 93%, Non-condensing Operating Atmospheric Pressure 700 hPa – 1060 hPa Storage and Transport Temperature -25~70ºC; -13~158ºF Storage and Transport Relative Humidity 10% – 93%, Non-condensing Storage and Transport Atmospheric Pressure 700 hPa – 1060 hPa Charge Temperature 0~55ºC; 32~131ºF  3.1.2 QT ECG Electrode Strip The Electrode Strip is a self-adhesive, one-piece integrated electrode system. It attaches to the body and plugs into the QT ECG Recorder as shown in figure 3.1.2a. 26
   Fig. 3.1.2a  The Electrode Strip comes in 4 different sizes, depending on body size and shape. Find the right size by using the sizing chart (Table 3.1.2a).  Table 3.1.2a  Size Shoulder width (cm) S 28-36 M 36-40 L 40-46 XL >46   Warning: The Electrode Strip is not defibrillator-proof. Do not use high 27
  voltage device such as AED while the Electrode Strip is still attached to the body.  Caution: The Electrode Strip shelf life is one year. Do not use if past expiration date. 3.1.3 Wall Charger This medical grade AC-to-DC power adapter provides external isolation from AC mains. Use the wall charger provided to charge your QT ECG Recorder. Use only 100-240v wall socket-outlet.   Warning: Do not use any external power supply such as portable battery charger or PC to charge the QT ECG Recorder  Caution: Use only wall charger provide by QT Medical. If your wall charger is lost, contact support@QTMedical.com for replacement.  3.1.4 QT ECG App The QT ECG App is an integral part of the QT ECG system. It works with most Apple and Android-based mobile devices. See Table# on page # for a list of compatible devices. To see how this app works, watch our video tutorial (URL).   Warning: Always use the latest version of the QT ECG App.   Warning: Run virus scan regularly on your mobile device.   3.2 System Setup A one-time setup is required before you can begin using the QT ECG system. Have your 28
  Bluetooth-enabled mobile device and the QT ECG Recorder ready, then follow the steps below: 1. New User Registration Email the serial number of your QT ECG Recorder to service@QTMedical.com. Your username and password will be emailed to you after your unit is registered 2. Download the Mobile App Download the QT ECG App from the Apple App store or Google Play 3. Log-in Open the QT ECG App on your mobile device and login using the username and password provided in step 1 above. 4. Bluetooth Pairing I. While the App is open on your mobile device and you are logged into your account, turn on your QT ECG Recorder by pressing down on the power button for 5 seconds until the PWR indicator light turns solid green.  II. Tap the “Connect” button shown in the QT ECG App on your mobile device, which will begin scanning for the QT ECG Recorder. III. When the CON indicator light turns solid blue, the units are paired. 5. Enter Patient Profile 3.3 Equipment Preparation  Charge the QT ECG Recorder fully before the first use.   Warning: Visually inspect the QT ECG and all accessories before use. Do not use if any component appears damaged. For support contact service@QTmedical.com  3.4 Patient Preparation ●Make sure the skin on the chest is clean and dry, free of lotion or oil. For males with lots of hair on the chest, shave the chest along the area indicated 29
    ●The patient should rest (sit still or lie down) for at least 5 minutes before taking an ECG recording.  3.5 Selecting Electrode Strip Size The Electrode Strips come in 4 different sizes. Use the sizing chart below to find the size that is right for you.  4. OPERATING PROCEDURES 4.1 Attaching the Electrode Strip  Warning: Do not attach the Electrode Strip onto yourself. Ask a trusted adult to help you.   Caution: Do not tug at the cables attaching the electrodes (RA, LA, LL) to the Electrode Strip. Keep the cables and the 3 external electrodes clear of the adhesive side of the Electrode Strip.  30
  1. Tear open the QT ECG Electrode Strip (Strip) package. Remove the plastic cover to expose the sticky side of the Strip.  2. With the sticky side facing patient, place the strip on the patient’s chest. First, position the Blue Box at the center of the chest, between the nipples. Then, wrap the strip from the center of the chest around the left side of the chest. The Red Arrow should be pointing to the left nipple. For females, the Strip should go under the left breast.   If placement of the Electrode Strip needs adjustment, the Electrode Strip 31
  can be lifted off for repositioning  3. Remove the adhesive backing of the other 3 electrodes (RA, LA, LL), one at a time.  ●The Black electrode (LA) goes on the upper left arm of the patient ●The White electrode (RA) goes on the upper right arm of the patient ●The Red electrode LL goes on the left hip joint 4. Press firmly on the Electrode Strip and all electrodes to ensure the attachments are secure  4.2 Connecting the QT ECG Recorder 1.  Connect the Recorder to the Strip by inserting QT ECG into the connector on the Electrode Strip. Insert the strip firmly until it is fully attached. 32
   2. Do not directly place QT ECG on the body, use a gauze pad to separate the device with the skin. 3. Press and hold the Power button for 5 seconds to turn on the QT ECG Recorder.  4. The Recorder is recording when Power (PWR) is Green, Connection (CON) is Blue, and Recording (REC) is blinking Amber. 33
   4.3 Taking an ECG Recording For the QT ECG App software operation, please see the following ●Tap the QT ECG App icon to activation of the app  ●Log in: Input username and password, then press the login button. 34
  35
    ●Input patient’s profile: Click the “Patient”, to input the patient’s medical record number (MRN, if applicable), Name, DOB, Electrode Strip size. 圖示36
   37
   ●Input patient’s symptoms: Click the “Note” button to input patient’s symptoms. 38
   39
   ●Scan and connect QT ECG Recorder: Tap on the “Connect” button, device will scan for the recorder. If found, the device will automatically connect and start receiving signals from the QT ECG Recorder 圖示40
   41
    ●Check lead-off: The screen displays the status of all leads on the user’s chest.  Check the ”Lead” button, make sure all the leads are in green color. If “Lead off” alert is shown (amber), please trouble- shoot the electrode attachment. Refer to the User Manual if needed. 圖示42
   ●Record ECG Data: An ECG tracing will be displayed on the screen. Tap on the “Record” button. The ECG will be recorded.  圖示43
   ●Upload ECG file: When record ECG complete, app will upload ECG file automatically.  ●ECG file list: If upload ECG file complete, you can tap ”Open File” button to get the file list. 44
   45
    ●Detail view: Click the "Detail" button, you can get more than 12 ECG details. And can use the caliper to measure the value of each point.  46
   47
    ●Add comment: Click the “New Comment” button, you can add new comment. 48
    ●Serial comparison: Choose any two ECG files of the same person, and click the "Serial comparison" button to conduct ECG comparison.  49
   50
    4.4 Detaching the Device After finish record ECG, disconnect the bluetooth and turn off QT ECG recorder. 5. TROUBLESHOOTING 5.1 QT ECG Recorder ●Problem: PWR LED indicator does not light up during charging ○Solution: PWR LED indicator will turn off after it is fully charged, If the PWR LED does not light up with charging, this may indicate that battery is fully charged. ●Problem: Unable to turn on the QT ECG Recorder ○Solution: Press and hold the power button for 30 seconds. If 51
  Power LED indicator still does not light up, please try again after charging the device for 1 hour. ○Solution: If above solution does not work, please contact our customer service. ●Problem: Unable to turn off the QT ECG Recorder ○Solution: Make sure the micro-USB cable is not connected ○Solution: Press and hold power button for 30 seconds.  If still unable to turn off the QT ECG Recorder, please contact our customer service. ●Problem: Unable to connect the QT ECG Recorder to the mobile device via Bluetooth ○Solution: If Bluetooth is not connected when it is on, please turn off the recorder then turn on the recorder again.  5.2 QT Electrode Strip ●Problem: Package opened or damaged before use ○Solution: Do not use the Electrode Strip, contact our customer service for replacement. ●Problem: 7 chest lead electrodes or 3 limb lead electrodes are damaged or missing ○Solution: Do not use the Electrode Strip and contact our customer service. ●Problem: Size of Electrode Strip enclosed does not match with package labels ○Solution: Do not use the Electrode Strip and contact our customer service. 52
  5.3 QT ECG App ●Problem: Crashed during use ○Solution: Reboot and restart, if problem persists, please contact our customer service. ●Problem: Cannot boot up application or the app quits unexpectedly ○Solution: Please contact our customer service. ●Problem: Application is not performing smoothly ○Solution: Too many apps may be open and running at the same time. Please reboot the mobile device and try again. ●Problem: All ECG tracings disappear on the display. The screen display looks like the following: ○Solution: The problem may be caused by system overload or saturation.  Please carefully remove the Electrode Strip from the patient’s chest and disconnect the QT ECG ECG Recorder.  Please restart the entire process. If the problem persists, please contact our customer service. ●Problem: Lead-off warning. The screen display is as follows: ○Solution: Check the corresponding chest electrode. Make sure the electrode is attached properly to the skin and making a good contact. ●Problem: Low battery warning. The screen displays the following: ○Solution: Disconnect the Recorder from the Electrode Strip, and remove electrode from the user. Charge the QT ECG Recorder using the wall charger with the micro-USB cable. Do not record and charge at the same time. 5.4 Others ●Problem: Cannot record ECG signals ○Solution: Review the user manual to ensure all steps and 53
  instructions are properly followed.  ○Solution: If the instructions are properly followed but the app problem persists, please shut down the application, reboot, and try again. ○Solution: If instructions are followed but the problem persists, press the power button to shut down and reboot the QT ECG Recorder and try again. ○Solution: If all steps are followed, but the recorder still cannot record ECG, please contact our customer service. ●Problem:  Cannot find the recorder while connection  ○Solution: Check the recorder is on.  6. PREVENTIVE AND MAINTENENACE The following sections describe how to clean and/or disinfect the QT ECG system, including                           recommended cleaning and disinfecting solutions and methods. It also covers the routine                       preventive maintenance for the QT ECG Recorder. 6.1 QT ECG Recorder To clean the QT ECG Recorder, dampen a soft cloth with lukewarm soapy water or natural                               cleaner and gently wipe down the recorder. The QT ECG Recorder should never be                           immersed in water under any circumstances. Take care not to scratch the device with                           abrasive cleaners or excessively wipes on the label. The QT ECG ECG Recorder should be                             gently cleansed before every use. To disinfect the QT ECG Recorder, dampen a soft cloth                             with isopropyl alcohol. Regularly inspect the QT ECG Recorder for damage such as warping                           or cracking. If there is any damage, please do not use it and contact the customer service. 6.2 QT Electrode Strip The Electrode Strip is for one-time use only.  There is no need to clean. 6.3 Wall Charger The cleaning procedure for the wall charger is the same as the QT ECG Recorder. Please                               disconnect the wall charger from power sources before beginning any cleaning procedure. 54
  7. TROUBLESHOOTING 7.1 QT ECG Recorder ●Problem: PWR LED indicator does not light up during charging oSolution: PWR LED indicator will turn off after it is fully charged, If the PWR LED does not light up with charging, this may indicate that battery is fully charged. ●Problem: Unable to turn on the QT ECG Recorder  oSolution: Press and hold the power button for 30 seconds. If Power LED indicator still does not light up, please try again after charging the device for 1 hour. oSolution: If above solution does not work, please contact our customer service. ●Problem: Unable to turn off the QT ECG Recorder oSolution: Make sure the micro-USB cable is not connected oSolution: Press and hold power button for 30 seconds.  If still unable to turn off the QT ECG Recorder, please contact our customer service. ●Problem: Unable to connect the QT ECG Recorder to the mobile device via Bluetooth oSolution: If Bluetooth is not connected when it is on, the blue CON LED indicator will blink. When properly connected, CON LED indicator will be a solid light. If CON LED indicator is off or blinking when turned on, please contact our customer service. 7.2 QT Electrode Strip ●Problem: Package opened or damaged before use oSolution: Do not use the Electrode Strip, contact our customer service for replacement. ●Problem: 7 chest lead electrodes or 3 limb lead electrodes are damaged or missing  oSolution: Do not use the Electrode Strip and contact our customer service. ●Problem: Size of Electrode Strip enclosed does not match with package labels 55
  oSolution: Do not use the Electrode Strip and contact our customer service. 7.3 QT ECG App ●Problem: Crashed during use oSolution: Reboot and restart, if problem persists, please contact our customer service. ●Problem: Cannot boot up application or the app quits unexpectedly oSolution: Please contact our customer service. ●Problem: Application is not performing smoothly oSolution: Too many apps may be open and running at the same time. Please reboot the mobile device and try again. 56
  ●Problem: All ECG tracings disappear on the display. The screen display looks like the following:  oSolution: The problem may be caused by system overload or saturation. Please                       carefully remove the Electrode Strip from the patient’s chest and disconnect the                       QT ECG ECG Recorder. Please restart the entire process. If the problem persists,                         please contact our customer service. 57
  ●Problem: Lead-off warning. The screen display is as follows:  oSolution: Check the corresponding chest electrode. Make sure the electrode is attached properly to the skin and making a good contact.  ●Problem: Low battery warning. The screen displays the following:  58
  oSolution: Disconnect the Recorder from the Electrode Strip, and remove electrode from the user. Charge the QT ECG Recorder using the wall charger with the micro-USB cable. Do not record and charge at the same time. 7.4 Other ●Problem: Cannot record ECG signals oSolution: Review the user manual to ensure all steps and instructions are                       properly followed.   oSolution: If the instructions are properly followed but the app problem persists,                       please shut down the application, reboot, and try again. oSolution: If instructions are followed but the problem persists, press the power                       button to shut down and reboot the QT ECG Recorder and try again. oSolution: If all steps are followed, but the recorder still cannot record ECG,                         please contact our customer service. 8. CUSTOMER SERVICE SUPPORT For customer service support, please contact: QT Medical, Inc. 1001 W Carson Street, Suite U, Torrance, CA90502, U.S.A. TEL (424) 558-3500 FAX (310) 755-3108 service@qtmedical.com   Manufactured for: QT Medical, Inc. 1001 W Carson Street, Suite U, Torrance, CA90502, U.S.A. 59
  http://www.qtmedical.com  9. WARRANTY The Company warrants the QT ECG against defects in materials and workmanship under                         ordinary clinical use for one year from the delivery date. During this warranty period, if a                               defect arises in the QT ECG, the Company will at its option, to the extent permitted by law,                                   either (i) repair the QT ECG ECG Screen using either new or refurbished parts, (ii) replace QT                                 ECG with a new or refurbished device that is equivalent to the device to be replaced, or (iii)                                   if (i) or (ii) are not reasonably possible, refund you all or part of the purchase price of QT                                     ECG, as deemed appropriate by the Company. This limited warranty applies, to the extent                           permitted by law, to any repair, replacement part or replacement device for the remainder                           of the original warranty period or for ninety days, whichever period is longer. All replaced                             parts and devices for which a refund is given shall become the Company’s property. This                             limited warranty applies only to hardware components of the QT ECG that are not subject to                               accident, misuse, neglect, fire or other external causes, alterations, or repair. Should a                         warranty repair be required, please contact customer service at                 service@qtmedical.com. In general, the Company will send you packaging that you                     can use to return the device to the appropriate customer service location. Third party                           tablets or computer devices are not covered under the Company’s warranty. Warranty                       claims for tablets or other mobile computing devices should be directed to the original                           manufacturer of those devices.  APPENDIX 60
  A. FCC Statement B. IC Statement C. Advice for Electromagnetic interference    61
  APPENDIX A  FCC Statement 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. NOTE: 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. 62
  Changes or modifications not expressly approved by the party responsible for compliance could                         void the user’s authority to operate the equipment.    63
  APPENDIX B IC Statement   64
   APPENDIX B  IC Statement This device complies with Industry Canada license-exempt RSS standard(s). Operation is                     subject to the following two conditions: (1) this device may not cause interference, and                           (2) this device must accept any interference, including interference that may cause                       undesired operation of the device. Le present appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisee aux deux conditions suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’utilisateur de l’appareil doit accepter tout brouillage radioelectrique subi, meme si le brouillage est susceptible d’en compromettre le fonctionnement.    65
  APPENDIX C   Taiwan requlatory information(NCC) 低功率電波輻射性電機管理辦法 第十二條            經型式認證合格之低功率射頻電機,非經許可,公司、商號或使用者均不得擅自變更頻率、加大功率或變更原設計之特性及功能。   第十四條            低功率射頻電機之使用不得影響飛航安全及干擾合法通信;經發現有干擾現象時,應立即停用,並改善至無干擾時方得繼續使用。           前項合法通信,指依電信法規定作業之無線電通信。低功率射頻電機須忍受合法通信或工業、科學及醫療用電波輻射性電機設備之干擾。    66
  APPENDIX D Advice for Electromagnetic interference The following is information on potential electromagnetic interference and advice on how to avoid or minimize such interference.  Guidance for Electromagnetic Emissions:  QT ECG is intended for use in the electromagnetic environment specified below. The customer or the user of QT ECG should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 2 QT ECG must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.  RF emissions CISPR 11 Class B QT ECG is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ Flicker emissions  IEC 61000-3-3 Complies  Guidance for Electromagnetic Immunity: QT ECG is intended for use in the electromagnetic environment specified below. The customer or the user of QT ECG should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment –guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact  ±8 kV air ±6 kV contact  ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. 67
  Electrical fast transient/burst  IEC 61000-4-4 ±2 kV for power supply lines  ±1 kV for input/output lines ±2 kV for power supply lines  ±1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV line(s) to line(s)  ±2 kV line(s) to earth ±1 kV line(s) to line(s)  ±2 kV line(s) to earth Mains power quality should be that of a typical commercial or hospital environment.  Interruptions and voltage variations on power supply input lines  IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0.5 cycle  40 % UT (60 % dip in UT) for 5 cycles  70 % UT (30 % dip in UT) for 25 cycles  <5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 0.5 cycle  40 % UT (60 % dip in UT) for 5 cycles  70 % UT (30 % dip in UT) for 25 cycles  <5 % UT (>95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of QT ECG requires continued operation during power mains interruptions, it is recommended that QT ECG be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field  IEC 61000-4-8 3 A/m  3 A/m  Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.  QT ECG is intended for use in the electromagnetic environment specified below. The customer or the user of QT ECG should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance                      Portable and mobile RF communications equipment should be used no closer to any part of QT ECG, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 68
   Conducted RF IEC 61000-4-6   Radiated RF IEC 61000-4-3   3 Vrms 150 kHz to 80 MHz   3 V/m 80 MHz to 2,5       GHz   3 Vrms    3 V/m   Recommended separation distance d = 1.2     d = 1.2  80 MHz to 800 MHz  d = 2.3  800 MHz to 2,5 GHz  where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).  Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b  Interference may occur in the vicinity of equipment marked with the following symbol:   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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which QT ECG is used exceeds the applicable RF compliance level above, QT ECG should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating QT ECG. b  Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.  Recommended Separation Distances between Mobile RF 69
  Communications Equipment and QT ECG: QT ECG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of QT ECG can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters). According to the maximum output power of the communications equipment, recommended environment for QT ECG is described below, Rated maximum output power of transmitter W  Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2  80 MHz to 800 MHz d = 1.2  800 MHz to 2.5 GHz d = 2.3  0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.  NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.    Appendix E. Compliance for Emissions and Immunity Standard Standard Edition Biocompatibility ISO 10993-10:2002/Amd 1:2006, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization; ISO 10993-5:1999, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. 70
  Electrical Safety IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012, IEC 60601-1-11:2015, EN 60601-1:2006+A1:2013+A12:2014+US DEVIATION, IEC 60601-2-25:2011 Electromagnetic Compatibility (EMC Safety) IEC 60601-1-2:2014 Electrode ANSI/AAMI EC12:2000/(R)2010, Battery IEC 62133:2012 Wall-Charger EN60601-1-2:2014_GROUP 1 Class B FCC PART 15 & PART 18 CLASS B UL ES60601-1:2005 CSA C22.2 NO.60601-1:2008 EN60601-1:2006 IEC 60601-1:2005 EN60601-1-11 BSMI CNS 14336-1 Electrocardiograph Performance IEC 60601-2-25:2011 RF Meet FCC, IC, CE, NCC CE R&TTE EN 301489-1V1.9.2 CE R&TTE EN 301489-17v2.1.1 CE R&TTE EN 300328 V2.1.1 FCC Part 15B 71
  FCC Part 15C   72

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