Device name: SNM-FDC01 Transcutaneous Electrical Acustimulator (TEA) Instructions for use Manufacturing and after-sales service company: Ningbo MedKinetic Medical Device Co., Ltd. Production Address: Lushan West Road, 167-8, Ningbo Free Trade Zone(South), 315806 Ningbo Phone: +86 574 86808886 Fax: +86 574 86808885 Production License Number: Registration Certificate No.: Table of contents Indications for Use Safety warnings and precautions Chapter 1: Product overview 1.1 List of included parts 1.
Indications for Use TEA Device is an Over-The-Counter Class II medical device intended to activate healthy nerves in order to improve or facilitate health. It is to be used by adults only. TEA Device is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of TEA Device stimulation programs are designed for injured or disease afflicted skin. Its use on such skin is contraindicated.
Safety warnings and precautions The warnings and precautions provided here are for intended and safe use of TEA Device in order to prevent harm or damage to users and others.
• During a stimulation session, do not disconnect the lead cable and electrode pads during stimulation; stop the stimulation first • • For first time users, skin stimulation can produce an unusual sensation. We recommend that you begin in a seated position with low stimulation settings to familiarize yourself with the sensation before progressing to higher intensities Some people with very sensitive skin may experience redness under the pads after the stimulation session.
Chapter 1: TEA Device and accessories 1.1 List of included parts Part Name Quantity TEA Device 1 Lead cable 1 USB charging cable 1 USB power adapter 1 Electrode pads 2 Holding strap 1 Holding clip 1 1.2 TEA Device As shown on Figure 1, the front of TEA Device has a display and buttons for viewing and setting the device operations. A magnetic snap connector is located on the back of TEA Device. The interface can be used to connect the lead cable or the charging cable.
Fig. 2 USB charging cable 1.4 Lead cable Connection of the lead cable and the electrode pads is shown on Figure 3: magnetic snap connector of the lead cable is connected to TEA Device, while two male connectors on the other side are connected to two electrode pads, which are placed on the skin to inject electrical current through the human body. Fig. 3 Lead cable connection 1.
Zusanli (ST36) lower Guanyuan (CV4), higher Zhongwan (CV12) Fig. 4 Common locations for electrode pad placement Neiguan (PC6) 1.6 Holding strap Based on electrode pad placement, TEA Device can be attached to an arm or leg by using the holding strap. The strap is first passed through the slit on TEA Device. After connecting the lead cable with electrode pads and setting stimulation amplitude on the TEA Device, wrap the strap with TEA Device around the arm or leg and adjust the length of comfort. 1.
Display Strength Adjustment Operating keys Fig 5. Operating the device Countdown Operating clock mode Stimulus strength Connection state Battery level Fig. 6 Display indicators 2.2 Initiating treatment Press the Power button to start the treatment process. Once the treatment starts, countdown begins at the upper-left corner of the screen. Figure 7 illustrates two operating modes: Standby mode and Treatment mode.
device. 2.6 Using the TEA App Install the TEA App on the Android smart phone, as shown on Figure 8. Fig. 8 TEA Device control app icon Once the TEA app is launched on the phone, TEA Device can establish wireless Bluetooth connection with the phone. Once the Bluetooth connection to the phone is established, the Connection State indicator on the bottom right corner of the display is changed from "Not Connected" to "Connected" state, as shown on Figure 9. Not connected Connected Fig.
Fig. 11 New User Registration screen Once completing the registration, please enter the login information on login screen, as shown on Figure 12: Fig. 12 Login screen If you forget the account password, please click on the "Forgot password" link, please go to the Forgot Password screen, please enter the registered mobile phone number or email number and click the "Submit" button. the TEA App will send the account password to your mobile phone or email, as shown on Figure 13.
Figure 13 Forgot password screen Select the Treatment mode: Click on icon on top left corner to activate pop-up menu and click “Therapy” to enter the treatment interface as shown on Figure 14. Fig.
Initiate the Therapeutic function operation 1) device Search and connection Device Search Device connection 2) Stimulating function operation Start stimulating. Stop stimulating Adjust the output stimulation strength (+/-) 4.Device Info 4.
You can go to the Add Device page by clicking the "Add Device" button, the pop-up menu "add Manually" (or you can add a device by sweeping the QR code), as shown in the following figure: Enter TEA Device number and Bluetooth according to the indicator on the back of the device Mac, and select prescription information, etc.
4.2 Delete devices and data downloads On the Device Information page，You can swipe a row of device information from right to left，Can seeThe download and delete buttons are shown in the following figure: 1) Download: This feature provides users with information about the treatment in the download stimulation device; 2) Delete: This feature provides users with the ability to delete false or unwanted device information. 5.
You can go to the Add Prescription page by clicking the "Add Prescription" button, the pop-up menu "add Manually" (or you can add a device by sweeping the QR code), as shown in the following figure: 6.
Chapter 3: Electromagnetic compatibility 3.1 Cable Information Num Name ber 1 USB 2.0 AM to Magnetic snap connector(7p) Cable whether length to block 80Cm 是 Manufacturers Model Shenzhen Scs Fu Electronics 3.2Electromagnetic emission and immunity guidelines and manufacturer's statement 3.2.
Voltage Meet fluctuation/flashing emission GB 17625.2 3.2.
70% UTFor a period of 25 25 UTOn, weeks UTOn, (in >30% 's temporary Drop) >30% (in 's temporary Drop) <5%uT, continuous 5s <5%uT, continuous 5s (in (in UTOn, >95% 's weeks UTOn, >95% 's temporary Drop) temporary Drop) Working frequency 3 a/m The frequency magnetic field should 3 a/m have magnetic field the characteristics of the (50/60Hz) frequency magnetic field in typical GB/T 17626.8 places in a typical commercial or medical environment. 3.2.
GB/T 17626.3 80MHz~2.5GHz D = 2.3 (P ) 800MHz-2.5GHz In the formula: p--according to the transmitter manufacturer to provide the maximum rated output power, in Watts (W); d-Is the recommended isolation distance, in meters (m). The field strength of a stationary RF transmitter is determined by the electromagnetic site survey and should be lower than the compliance level in each frequency range.
Recommended isolation distances between 3.2.4 portable and mobile RF communication devices and devices or systems-for non-life support devices and systems Recommended isolation distance between portable and mobile RF communication devices and devices or systems TEA Device is expected to be used in the controlled electromagnetic environment of radiofrequency radiation harassment.
Chapter 4: Fault analysis and troubleshooting The specific exclusion method is prompted by the following table: Fault Cause analysis TEA Device Unable to start TEA Device Battery Exclusion method charge is empty start again. Hardware failure Please set TEA Device “return to the original maintenance”. no Electrode line failure output Please follow the instructions to Stimulator Charging And try to Please replace the electrode line.
support app software Bluetooth such devices, Go to the Bluetooth Device Settings page and authorize the app as mobile software to use the Bluetooth module. phones, are not set up correctly and authorize TEA app to use Bluetooth modules. Bluetooth Devices and TEA Device are Please reduce the distance between TEA Device and the Bluetooth device (phone). Try the connection again. too far away from each other.
Chapter 5: Product Maintenance 5.1 Maintenance Please clean TEA Device often. If the skin is oily or wet, please wipe it with a dry soft cloth. If necessary, it can be disinfected by gently wiping with a cotton round dipped in sterilized alcohol. 1) Do not use diluent, gasoline, volatile oil and so on to wipe. 2) do not clean or wet products and accessories. 3) Please do not keep in the following cases: ●Where there is water.
Chapter 6: Product Warranty TEA Device is covered by a one-year warranty from the date of purchase (proof of purchase is required). Warranty applies to the TEA Device itself and does not cover lead cable, USB charging cable, electrode pads, holding strap and holding clip.
Chapter 7: Technical Specifications Name Transcutaneous Electrical Acustimulator (TEA) Model SNM-FDC01 Power supply Power Internal battery Battery type Rechargeable 3.7V Lithium-Polymer Battery 650 mAh Charging Input 5V through USB 2.
Chapter 8: Applied Standards Standard number Description IEC 60601-1: 2005+A1:2012 General requirements for basic safety and essential performance IEC 60601-1-2: 2014 Collateral standard: Electromagnetic disturbances - IEC 60601-1-6: 2010+A1:2013 Collateral standard: Usability IEC 60601-1-11: 2015 Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in homecare environment IEC 60601-2-10: 2012 Particular requirements for the basic safety and essen
Chapter 9： 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. Attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Manufacturer information Ningbo MedKinetic Medical Device Co., Ltd. Address: Lushan West Road, 167-8, Ningbo Free Trade Zone(South), 315806 Ningbo Phone: +86 574 86808886 Fax: +86 574 86808885 Email: support@medkinetic.com USA Authorized Representative Medipace Inc Address: 420 S Madison Ave, Suite 206, Pasadena, CA 91101, USA Phone +1 626-497-9441 Email support@medipaceinc.
