QT Medical QT ECG QTERD100, User Manual

Page 1: ...u 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 cauti...

Page 2: ...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 revi...

Page 3: ...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 Ther...

Page 4: ...trical 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...

Page 5: ...om particulate matter and water 2 represents that protection against object sized 12 5mm Fingers or similar objects 2 represents that the enclosure has a protection level of water jet Vertically dripp...

Page 6: ...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...

Page 7: ...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 stat...

Page 8: ...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 c...

Page 9: ...umidity 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 Ma...

Page 10: ...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 Nev...

Page 11: ...ted 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 strangul...

Page 12: ...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 o...

Page 13: ...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 Stri...

Page 14: ...G 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...

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Page 16: ...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...

Page 17: ...The Electrode Strip is packaged and sold separately 17...

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Page 19: ...ed 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...

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Page 22: ...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 char...

Page 23: ...ual 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 rec...

Page 24: ...r 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...

Page 25: ...hannel 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 V...

Page 26: ...Temperature 25 70 C 13 158 F Storage and Transport Relative Humidity 10 93 Non condensing Storage and Transport Atmospheric Pressure 700 hPa 1060 hPa Charge Temperature 0 55 C 32 131 F 3 1 2 QT ECG E...

Page 27: ...ferent 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 i...

Page 28: ...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...

Page 29: ...r 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 mobi...

Page 30: ...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 y...

Page 31: ...rip 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 s...

Page 32: ...te 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...

Page 33: ...se 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...

Page 34: ...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...

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Page 36: ...Input patient s profile Click the Patient to input the patient s medical record number MRN if applicable Name DOB Electrode Strip size 36...

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Page 38: ...Input patient s symptoms Click the Note button to input patient s symptoms 38...

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Page 40: ...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 40...

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Page 42: ...lays 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 t...

Page 43: ...Record ECG Data An ECG tracing will be displayed on the screen Tap on the Record button The ECG will be recorded 43...

Page 44: ...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...

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Page 46: ...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...

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Page 48: ...Add comment Click the New Comment button you can add new comment 48...

Page 49: ...Serial comparison Choose any two ECG files of the same person and click the Serial comparison button to conduct ECG comparison 49...

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Page 51: ...order 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 th...

Page 52: ...nnect 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 Pr...

Page 53: ...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 Prob...

Page 54: ...nance 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 sh...

Page 55: ...olution 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 devic...

Page 56: ...restart if problem persists please contact our customer service Problem Cannot boot up application or the app quits unexpectedly o Solution Please contact our customer service Problem Application is...

Page 57: ...following o 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 resta...

Page 58: ...screen display is as follows o 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 scre...

Page 59: ...problem persists please shut down the application reboot and try again o Solution If instructions are followed but the problem persists press the power button to shut down and reboot the QT ECG Recor...

Page 60: ...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 refu...

Page 61: ...A FCC Statement B IC Statement C Advice for Electromagnetic interference 61...

Page 62: ...ses 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 i...

Page 63: ...Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment 63...

Page 64: ...APPENDIX B IC Statement 64...

Page 65: ...ng 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 autor...

Page 66: ...APPENDIX C Taiwan requlatory information NCC 66...

Page 67: ...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 domesti...

Page 68: ...ould 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 uninte...

Page 69: ...ot 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 r...

Page 70: ...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 t...

Page 71: ...ectrode 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...

Page 72: ...FCC Part 15C 72...