Swcan ECG Monitor Version:V1.0.0.0 User Manual Registrant/Manufacturer: Nanjing Swcan Information Technology Co., Ltd Post-Sales Support: Nanjing SWCAN Information Technology Co., Ltd Attention: Please read the user manual carefully before using, maintaining or repairing the device. The manual is for instructional purposes only. Our company reserves the right to improve the design of the device.
Table of Contents 1.Safety Warnings 2.Product Information 3.User Guide 4.Miscellaneous Functions 5.Troubleshooting 6.Maintenance 7.Technical spec and performance 8.Warrenty card 9.Circuit diagram 10.Packing list 11.
Thank you for purchasing the Swcan ECG Monitor. Please read this manual carefully before using the product. Please keep this manual for reference when using the product. In case of damage or loss of this manual, please contact us. This product is suitable for patients who are intended operators .
1. Safety warnings All warning labels are designed to help you to use our product safely, preventing any possible damages to you or others. Label Warning May cause death or serious injuries if used improperly. Please refrain from disassembling, repairing or modifying the device as it may result in inaccurate measurements. Only disassemble when replacing the battery according to instructions.
11. Except the normal battery replacement, please do not disassemble or attempt to repair the device to avoid malfunction. 12. Please do not throw the device in fire since the battery can explode and cause injury or death. 13. Please do not dispose the device and its accessories as ordinary household garbage. Dispose them in accordance with the requirements of medical device standards. 14.
Button Upper Shell Cover Circuit Board Lead Snap Button Battery Slot Lower Shell Cover Battery Cover 2.3 Product Classifications 2.3.1 Electrical Shock Protection Classification This product is classified as an internal powered device based on its protection classification 2.3.2 Degree of protection against electric shock This product is classified as a CF type device based on its degree of protection 2.3.
Atmospheric pressure range: 50Kpa～106Kpa 2.4.2 Operating Environment Temperature: 5～450℃ Relative Humidity: ≤9580% Atmospheric pressure range: 86Kpa ～106Kpa The device must not be used with flammable anesthetic gas mixed with air or nitrogen oxide mixed with flammable anesthetic gas. 2.5 For people This product is suitable for infants weighing over 10kg, children, adults and the elderly. 2.6.Target users: The target users of this product are medical institutions and individuals. 2.7.
1:Central 2:Indicator light 3:Upper electrode lead Processor 6:Metal ring 4:Lower electrode 5:Button lead 7: Back cover (Battery 8: Electrode snap compartment) button 2.12.1.
2.12.1.2Cell Battery The SWK801 ECG Monitor requires a single non-rechargeable CR2032 cell battery. Please purchase high quality batteries from certified sales channels. 2.12.1.3 Smartphone APP Download free from the designated website and install it on your (Bluetooth enabled) smartphone 2.12.1.4 Accessory (Outer box) 2.13 The Swcan ECG Monitor software 2.13.1 Name: Swcan ECG Monitor software 2.13.2 Model number: SWK801 2.13.3 Version naming convention: Naming convention: X.Y.Z.
RAM:128KB Data storage: 128MB ADS: 16-bit dual-channel low-energy analog-to-digital converter. Battery: CR2032 cell battery Network: 2.4G Bluetooth Low Energy 3、Operating Guide 3.1 Smartphone APP installation guide This APP supports bluetooth enabled smartphones with at least 50M free storage available.
Icon 7 ECG Results History Tap the icon to access ECG results history. 3.3 How to use the Swcan ECG Monitor 3.3.1 Battery installation Please rotate and open the back cover (a coin can be used in the slot to assist), place a new CR2032 battery inside the battery compartment with the positive (+) side up, then replace the cover and rotate to tighten. A steady green light indicates the device is ready.
Warning: the device should be attached on your left chest with the side marked with red dot pointing up at a 45 degrees angle towards your right shoulder, as shown in illustration b above. 3.3.3 Starting measurements Method 1（recommended）：Use the smartphone app to start the measurements. Ensure the device has sufficient power, indicated by a steady green light. Start the app, turn on Bluetooth as instructed, connect to the device.
Warning: This operation will discard any measurement data that didn’t upload last time, so it is not recommended to use this under normal circumstances. 3.3.9 Disposable ECG electrodes After a measurement session is completed, please detach the device first, then remove the disposable electrodes from your body. Please do not throw the electrodes as trash, but recycle it according to the medical device recycling standards instead. 3.3.
5、Troubleshooting Problems Reasons Measures The indicator light no longer flash during measurement (Every 5 seconds) The battery is depleted Replace with a new battery After putting in the battery, the green light does not come on or stay on The battery is running low Replace with a new battery Device malfunctioned Please contact our company Bluetooth is not turned on Turn on Bluetooth The device is already The app cannot connect to connected to another the device smartphone The battery on the
7．1 Main parameters: Product model Channel Shock proof type Internal power supply SWK801 Single lead CF type DC.
For sinusoidal signals with frequency between 0.67Hz and 40Hz, the response amplitude should be between 140% and 70% of the response amplitude at 5Hz (+3dB to -3dB). The response amplitude for simulating a series of R wave narrow-wave 1.5mV 40ms triangular wave clusters should be between 60% and 110% of the response amplitude for 1.5mV 200ms triangular wave clusters.
customer or the user should assure that it is used in such an environment. IEC 60601IEC 60601 Electromagnetic Environment Immunity Test Compliance Level Test Level - Guidance Floor should be wood, concrete, or ceramic tile. Electrostatic discharge ±6kV contact ±6kV contact If floors are covered with (ESD) ±8kV air ±8kV air synthetic material, the GB/T 176626.2 relative humidity should be at least 30% GB/T 17626.
be less than the compliance level in each frequency b range. Interference may occur in the vicinity of equipment marked with the following symbol: Note1: At 80MHz and 800MHz, the higher frequency range applies. Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
failure to operate the device in accordance to the user manual; repair done by unauthorized repair shops. 3. When submitting a warranty claim, please submit the warranty certificate with clear purchase date and stamp of the shop where the product was purchased (including the name and address of the shop). Please ask the salesperson to stamp your warranty certificate at the time of purchase. 4. Repair costs will be charged for any work that falls outside the scope of the warranty. 5.
Registrant/manufacturer/post-sales services: Nanjing Swcan Information Technology Co.,Ltd Address: Room 215, Block B4, JIULONGHU International Headquarters Park, No. 19 Suyuan Avenue, Jiangning District, Nanjing City, Jiangsu China Production address: Room 215, Block B4, JIULONGHU International Headquarters Park, No.
Appendix A: Swcan ECG Monitor mobile app user manual Software specifications Software name: Swcan ECG Monitor app Model number: SWK801 Version naming rules: Naming rules:X.Y.Z.B； X represents a significant enhancement software update; Y represents slightly enhanced software updates; Z stands for corrective software updates; B is for build; App Release version of App: V1.9; App Full version of App: V1.9.1.1; Software component release version: V2.2; Full version of software components: V2.2.2.2.
System requirements Applicable system of this software: Android 6.0 above Recommended hardware configuration: Processor:ARM Cortex-M3 clock:48MHz RAM:128KB Date storage:128MB ADS: 16-bit two-channel low power AD converter Battery:CR2032 Button batteries Network environment:2.4g low power blue-tooth Use restrictions This software must be used with digital via-com electrocardiograph. Smart devices need to turn on the system blue-tooth switch.
The smart device can find the available device within 1 meter of the ecg and the blue tooth scan within 10 seconds. After scanning, connect to a specified device, can be connected in 10 seconds. Effect of efficiency: network bandwidth, intelligent device hardware configuration. Software data reliablity All the user data backup generated during the use of the software is stored in Azure cloud database and blob cloud, which has cloud automatic backup and high reliability.
1. Introduction to “Register” and “Sign in” functions After entering the App, the user needs to sign in first. Users can tap “Register” or “Sign in”. Register function allows users to create a user ID with mobile phone quick and easy. SMS verification is required for registration.
2. Introduction to “Measuring ” function There is a step-by-step measuring guide for users to set up ECG monitor and wear it. Wear the device correctly, make sure it has enough power, then tap “Connect”to set it up with mobile phone. Tap “Start measuring” to collect ECG data.
3.Introduction to a real-time ECG waveform diagram function After start measuring, measurement interface automatically pops out a real-time ECG waveform diagram with heart beats per minute and total time of measurement. （i） 3. Introduction to “End Measurement” function Tap “End Measurement“， slide bar to the right to confirm ending measuring.
4. Introduction to “Data Uploading” function After the measurement, “Data uploading” function will pop up automatically. It shows measurement date, timespan, and estimated uploading progress. Tap “Stop”to finish the data uploading.
5. Introduction to “Measurement Records” function Tap "Measurement Record" on the bottom navigation bar to view a list of measurement records. Measurement records can be sorted by recent measurements or by users.
6. Introduction to “User Profile” function Different users can share the ECG monitor by creating different profiles. Under “Measurement Record” page, select the right person to start measurement and check records. （o） 7. Introduction of “Playback ECG” function Tap the "Playback ECG" icon at the upper right corner under “Doctor’s Opinions“ page to view the ECG playback. Drag bottom bar icon to view intervals.
8. Introduction of online customer service function Click the "Customer service" in personal center and you can chat with the customer service representatives. （y） （z） 9. Set Sign-in password Click "Settings”. Under “Settings”, click “Setting Password”.
FCC Caution: Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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. FCC RF Radiation Exposure Statement: 1.
