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
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●Input patient’s symptoms: Click the “Note” button to input patient’s symptoms. 38
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●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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