Cardiac Monitor (Model:HR-0542F)
Contents 1. Product Introduction .............................................................................................................................. 3 1.1 Introduction ...................................................................................................................................... 3 1.2 For Help and Assistance .................................................................................................................. 3 1.3 Safety Related Labels and Symbols .............
1. Product Introduction 1.1 Introduction The device is designed for medical professionals to collect, record, store and automatically analyze patients' single lead dynamic ECG(electrocardiograms ) and heart sound signals. The system includes a wearable patch device collecting synchronized PCG (phonocardiogram) and ECG readings, a smartphone application (App), and a web application. The data collected from the wearable patch are sent to a cloud based data center for further analysis.
1.4 Signal Word Consequences Indicates a hazardous situation, which if not avoided, could result in injury and/or property damage and/or damage to the device. 1.5 Caution To reduce the risk of device interference, keep the device at least one meter away from all RF emitters. To reduce the risks associated with infection, follow the cleaning and disinfecting procedures included in this manual.
1.6 EMC Compliance FCC Intentional Radiator Certification Contains FCC ID:2AWXN0542 FCC Warning 15.19 Labeling requirements. 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. 15.21 Information to user.
1.7 Indication for Use This device is intended to be used by healthcare professionals for diagnostic decision support. It can electronically amplify, filter, and transfer body sound and single-channel electrocardiogram (ECG) waveforms. This device displays ECG waveforms and heart sounds waveforms on the accompanying mobile application for storage and sharing.
1.10 Technical Specifications 1) Use Environment Ambient temperature: 10℃ ~45℃. Relative humidity: 10%~95% (no condensation). Atmospheric pressure range: 700hPa ~1060hPa. Power supply: built-in 3.7V lithium polymer battery, voltage value allowable fluctuation range of ± 10%. The electromagnetic environment meets the requirements.
The package includes (1) Main device, one (2) User Manual, one For full functionality, the system requires users to connect the device with an internet-enabled smart mobile device using the APP. The APP supports many Apple and Android mobile device. System Requirements The mobile app software can be used on Apple devices with iOS 11.0 and higher. The mobile app software can also be used with Android devices with BLE support (Bluetooth 4.0 and above) and Android 6.0 and above. 1.
2.1 Patch Installation and Operation 1) Remove the blue protective film in the middle. 2) Fasten the patch with the device to ensure that the device and patch are fit together smoothly. 3) Remove the transparent protective film on the back of the patch before use. Caution: After removing the transparent protective film, please place it on the chest skin promptly. Prolonged exposure to the air will reduce the viscosity and affect the use effect. 2.
2.3 Device Placement Position Before the initial use, please try test points A and B to find your own best test point (the waveform is the most stable and strongest) and keep it consistent in future use. Test point A(Left of sternal border in fourth intercoatal space) Test point B(Left of sternal border in second intercostal space) Caution: Keep skin clean. If there is too much hair on the chest, shave before use to ensure that the patch can be fully attached to the chest.
2.4 Test Posture and Environment 1) Find a quiet environment. Keep body relaxed, half lying or half leaning. Do not lean or bend the body. Keep hands and feet relaxed 2) It is recommended to unbutton the clothes, try to avoid the pressure on the device during the test, and keep the body quiet and stable to reduce the interference caused by clothing friction. 3) During the test, please keep quiet, avoid talking, coughing or breathing deeply, and keep hands and feet relaxed.
3) Finally, remove the integrated patch completely. Caution: Do not use excessive force when removing the button. If you feel it is too tight to break, you can hold the patch, slowly rotate the button part, and try to break it from other angles. 2.6 Software Operation Restrictions • User login: must use an account that has been successfully registered. • User creation: required fields are name, age and gender.
2.7 APP use 1) Sign in [Login]: enter the account name and password, and click [Log in] to enter the data collection page. 2) User list On the data collection page, click the photo icon in the upper left corner to enter the user list page. The user list page displays all users under the current account. You can switch, add, edit users. ① Switch user: click [Set ] as current user, and the collected data belongs to the current user.
3) Data collection and playback Input of body parameters: ① Physical state: single choice, choose from after exercise, calm and mild activity. ② Subjective feelings: multiple choices, choose from comfort, chest discomfort, heart discomfort, head discomfort and others. ③ Blood pressure and systolic blood pressure can be input in the range (0, 300) and diastolic blood pressure can be input in the range (0, 200).
4) Current User Current account: display the current login account information, click the account name to enter the account information page, and click [Exit] to exit the current login account. Heart sound and ECG: concepts related to ECG and heart sound. App version: displays the current series number of the software.
3. Electrical Safety Guidance and Manufacturer’s Declaration – Electromagnetic Emission The system is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment. Applicable Emissions Test RF emissions CISPR11 RF emissions CISPR11 Harmonic emissions IEC 61000 -3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Compliance Electromagnetic Environment - Guidance Group 1 The system uses RF energy only for internal function.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-411 environment. Mains power quality should be that of a typical commercial or hospital environment. ＜5% UT (＞95% dip in UT) for 0.
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, “should be less than the compliance level in each frequency range.” Interference may occur in the vicinity of equipment marked with the following symbol: Note1：At 80 MHz 和 800 MHz，the higher frequency range applies. Note 2：These guideline may not apply in all situations. Electromagnetic propagation is affected by absorption and is affected by absorption and reflection from structure, objects and people.
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 is meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum 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.
