all | frequencies |
|
|
|
|
exhibits | applications |
---|---|---|---|---|---|---|---|
manual | photos | label |
app s | submitted / available | |||||||
---|---|---|---|---|---|---|---|---|
1 |
|
User Manual | Users Manual | 811.40 KiB | July 26 2019 | |||
1 |
|
Internal Photos | Internal Photos | 645.81 KiB | July 26 2019 | |||
1 |
|
External Photo | External Photos | 526.69 KiB | July 26 2019 | |||
1 |
|
Label | ID Label/Location Info | 113.72 KiB | July 26 2019 | |||
1 |
|
Confidentiality Letter | Cover Letter(s) | 140.36 KiB | July 26 2019 | |||
1 |
|
Power of Attorney Letter | Cover Letter(s) | 169.02 KiB | July 26 2019 | |||
1 |
|
RF exposure Info | RF Exposure Info | 462.37 KiB | July 26 2019 | |||
1 |
|
Test Report | Test Report | 3.65 MiB | July 26 2019 | |||
1 |
|
Test SETUP photo | Test Setup Photos | 282.22 KiB | July 26 2019 |
1 | User Manual | Users Manual | 811.40 KiB | July 26 2019 |
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 1.2 TEA Device 1.3 USB charging cable 1.4 Lead cable 1.5 Electrode pads 1.6 Holding strap 1.7 Holding clip 1.8 TEA app Chapter 2: Directions for Use Chapter 3: Electromagnetic compatibility Chapter 4: Fault Analysis and Troubleshooting Chapter 5: Product Maintenance Chapter 6: Product Warranty Chapter 7: Technical Specifications Chapter 8: Applied Standards 3.1 Cable Information 3.2 Electromagnetic emission and immunity guidelines and manufacturer's statement 5.1 Maintenance and Maintenance 5.2 Waste Disposal 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. TEA Device electrical impulses allow the triggering of action potentials of nerves (excitations). Depending on the parameters of the electrical impulses (pulse frequency, ON and OFF durations, total session duration), different types of nerve excitations can be produced. TEA Device may therefore be considered a technique of neuromodulation. TEA Device is used for:
symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. CONTRAINDICATIONS A contraindication indicates a situation in which the device should not be used. Never use TEA Device if you have ANY of the following:
Atrophied muscles or need for muscle rehabilitation Muscles with spasms or persistent pain Cardiac stimulator (pacemaker) Epilepsy Cancer or cancerous lesions Any heart problem or condition Pregnancy (do not use on the abdominal area) Abdominal or inguinal hernia Mental disorders Serious arterial circulation disorders in lower limbs 2 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. The following symbols will be used throughout the manual:
Symbol Meaning High-level warning about a situation when if the device is used incorrectly it can result in death to the patient General warning about a situation when if the device is used incorrectly it can result in injury to the patient or user or damage to the equipment or other property Type BF application part two types of medical devices Attention! Consult documentation Precautions for use Please read this manual carefully first and always follow the instructions to operate. If pregnant or menstruating, do not place electrodes directly over the uterus or connect pairs of Please keep out of reach of children and pets Do not use in persons with contraindications to this product, as described on previous page electrodes across the abdomen Use only with the electrode pads supplied by manufacturer Do not cut the electrode pads Do not connect lead cable or electrode pads to the other objects Do not allow any foreign material (soil, water, metal, etc.) to get into the device Do not apply solvents of any kind to the electrode pads Do not touch the pads from the conductive side Do not attempt to place the pads on any part of the body which is not directly visible without assistance When attaching the pads, please ensure that the entire surface is in contact with the skin Do not apply over skin abrasions Apply to dry skin only; for oily skin, clean of any oil and dry it before attaching the electrode pads For hygienic reasons, each user must have his/her own set of pads. Do not use the same pads on different people Never use a set of pads for more than 30 stimulation sessions as their bonding power deteriorates over time and optimal contact is very important for both user comfort and stimulation efficacy 3 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. Generally, this redness is completely harmless and disappears after 15 to 20 minutes. However, avoid starting a stimulation session on the same area until the redness is no longer visible Do not use in environment with strong electromagnetic radiation, such as portable communications equipment Do not use within 1.5 meters of short wave or unshielded microwave devices as this could alter the current generated by the stimulator. removable metallic product or device in the area of stimulation Do not apply stimulation near metal. Remove jewelry, body piercings, belt buckles or any other Do not apply stimulation near the area of an implant, such as cochlear implants, pacemakers, electrical or skeletal anchorage implants Do not use in water or in a humid atmosphere (sauna, hydrotherapy, etc.) Do not use in an oxygen-rich atmosphere Do not use at altitudes of over 3,000 meters Sudden temperature changes can cause condensation to build up inside the stimulator. Only use the device once it has reached ambient temperature Do not use while driving, operating machinery or cycling Do not apply stimulation while sleeping Do not recharge the device when unit is attached to an electrode and/or on your body Do not apply electrode pads to the head, face, genitals, neck, both sides of the chest or torso at the same time For long-term storage, batteries should be removed from the device and stored separately Replace the drained battery timely to ensure normal use It is prohibited for users or non-professionals to disassemble or modify the device or accessories Turn off the device before removing the lead cable or pads Unplug the USB power adapter from the power socket before using the device Use only the provided USB power adapter for device charging. Using a different power adapter can be dangerous It is prohibited to use this device with accessories not supplied by manufacturer 4 Chapter 1: TEA Device and accessories 1.1 List of included parts Part Name TEA Device Lead cable USB charging cable USB power adapter Electrode pads Holding strap Holding clip 1.2 TEA Device Quantity 1 1 1 1 2 1 1 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. Display Operating buttons Magnetic snap connector 1.3 USB charging cable Fig. 1 TEA Device TEA Device is powered using an internal rechargeable lithium polymer battery. Once the device is turned on, the battery level indicator is located on upper-right corner of the display. When the battery is fully charged, treatment can be provided for up to 20 hours under normal operating conditions. When the battery is discharged, as can be seen on the battery level indicator, the USB charging cable should be connected for recharging the battery. For connecting the USB charging cable, its magnetic snap connector is connected to TEA Device, while its USB connector is connected to the USB jack of USB power adapter, as shown on Figure 2. Make sure to use the supplied USB power adapter that is approved for use with the US power lines (120 V, 60 Hz). 5 1.4 Lead cable Fig. 2 USB charging 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 1.5 Electrode pads As shown on Figure 4, the electrode pads are commonly placed on the following acupuncture points (acupoints) to achieve the best treatment results: Zusanli (ST36), Guanyuan (CV4), Zhongwan (CV12), or Neiguan (PC6). 6 Zusanli (ST36) lower Guanyuan (CV4), higher Zhongwan (CV12) Fig. 4 Common locations for electrode pad placement 1.6 Holding strap Neiguan (PC6) 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. 1.7 Holding clip TBD 1.8 TEA app The keys on TEA Device allow users to perform only basic operations, including starting and stopping treatment and adjusting the stimulus strength. In order to perform advanced operations, users have to install and use the companion TEA app on the Android phone. Chapter 2: Directions For Use 2.1 Preparing the device Before using this product for treatment, connect the TEA Device to the lead cable with electrode pads and attach the pads to the skin, as described in 1.6 and confirm that the device is charged. The charging instructions are in 1.3. 2.2 Turning the device ON To turn the device ON, press the Power button and hold for 3 seconds. TEA Device goes into Standby mode. 7 Display Strength Adjustment Operating keys Fig 5. Operating the device Countdown Operating Stimulus Connection Battery clock mode strength state 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. In order to avoid sudden unpleasant sensation of stimulation, the initial current should be set to 1.0 mA. Standby mode Treatment mode 2.3 Adjusting stimulation strength Fig. 7 Operating modes Apply a short press to and keys to adjust the stimulation strength. 2.4 Terminating treatment while in the Treatment mode, press the Power button to terminate the treatment process and enter Standby mode. 2.5 Turning the device OFF While in the Treatment or Standby modes, press the Power button and hold for 3 seconds to power off the 8 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. 9 Bluetooth connection state After starting the TEA App, go to the Welcome screen, as shown on Figure 10:
Fig. 10 Welcome screen Registration: click on the Welcome screen to enter the login screen. If using the App for the first time, you need to register the user account: please click on the login page "no account number?" Create a new account name and password, as shown on Figure 11:
9 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. 10 Figure 13 Forgot password screen Select the Treatment mode: Click on enter the treatment interface as shown on Figure 14. icon on top left corner to activate pop-up menu and click Therapy to Fig. 14 Treatment interface screen Enter the site Start the treatment 11 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 4.1 Add a Device information is empty, as shown in the following figure:
On the left menu, click "Device Information", go to the Device Information page, the default device 12 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., click the "Submit" button to add the device information to the TEA App, as shown in the following figure:
13 4.2 Delete devices and data downloads On the Device Information pageYou can swipe a row of device information from right to leftCan 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.Prescription information Prescription information is used to set the parameters of the stimulator output stimulation, which is generally the equipment factory or hospital doctors according to the subjects using the treatment of disease characteristics and input of the treatment parameters. On the left menu, click "Prescription Information", go to the Prescription information page, the default prescription is empty, as shown in the following figure:
14 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.My Health Data Report 15 Chapter 3: Electromagnetic compatibility 3.1 Cable Information Num Cable Name ber 1 USB 2.0 AM to Magnetic snap connector(7p) whether length to block 80Cm Manufacturers Model Shenzhen Scs Fu Electronics 3.2Electromagnetic emission and immunity guidelines and manufacturer's statement 3.2.1 Guide and Manufacturer's statement-electromagnetic emission Guide and manufacturer's statement-electromagnetic emission TEA Device is expected to be used in the following electromagnetic environments, and the purchaser or user should ensure that it is used in this electromagnetic environment:
Launch test RF emission GB 4824 RF emission GB 4824 Compliance Electromagnetic Environment-Guide 1 B TEA Device does not produce or use RF energy for material handling or inspection/analysis. TEA Device directly connected to residential low-voltage Harmonic radiation Class A power grid facilities for use. GB 17625.1 16 Voltage Meet fluctuation/flashing emission GB 17625.2 3.2.2 Guide and manufacturer's statement-electromagnetic immunity-for all devices and systems Guide and Manufacturer's statementElectromagnetic immunity TEA Device is expected to be used in the following electromagnetic environments, and the purchaser or user should ensure that it is used in this electromagnetic environment:
Disturbance IEC60601 Test level Compatible with level Electromagnetic Environment-Guide resistance test Electrostatic 6KV Contact 6KV Contact Discharge The ground should be woody, concrete Discharge (ESD) Discharge 8KV Air Discharge or tile, and if the ground is covered GB/T 17626.2 8KV Air Discharge with synthetic material, the relative humidity should be at least 30%. Electric Rapid 2KV to the power 2KV to the power cord The network power supply should have Transient pulse cord 1KV to input/output the quality used in a typical commercial Group 1KV Input/Output lines or hospital environment. GB/T 17626.4 Lang Chung 1KV Line Alignment 1KV Line Alignment The network power supply should have GB/T 17626.5 2KV line to the 2KV line to the ground the quality used in a typical commercial ground or hospital environment. Voltage drop, short
<5%uTFor a period of
<5%uTFor a period of The network power supply should have time interrupt and 0.5 weeks
(in 0.5 weeks
(in the quality used in a typical commercial voltage change on UTOn,
>95%
's UTOn,
>95%
's or hospital environment. If the user power input line temporary Drop) temporary Drop) needs to run continuously during a GB/T 17626.11 40% UTFor a period of 40% UTFor a period of 5 power outage, the recommended 5 weeks
(in weeks (in UTOn, >60% 's device is powered by an uninterruptible UTOn,
>60%
's temporary Drop) electricity supply or battery temporary Drop) 70% UTFor a period of 17 70% UTFor a period of 25 weeks 25 weeks
(in UTOn,
>30%
UTOn,
>30%
's temporary Drop)
(in
's temporary Drop)
<5%uT, continuous 5s
<5%uT, continuous 5s
(in UTOn, >95%
's
(in UTOn, >95%
's temporary Drop) temporary Drop) Working frequency 3 a/m 3 a/m The frequency magnetic field should magnetic field
(50/60Hz) GB/T 17626.8 have the characteristics of the frequency magnetic field in typical places in a typical commercial or medical environment. 3.2.3 Guide and Manufacturer's statement-electromagnetic immunity-for non-life support equipment and systems Guide and Manufacturer's statementElectromagnetic immunity TEA Device is expected to be used in the following electromagnetic environments, and the purchaser or user should ensure that it is used in this electromagnetic environment:
Disturbance IEC60601 Test level Compatible with level Electromagnetic Environment-Guide resistance test RF conduction GB/T 17626.6 3V (valid value) 150KHz~80mhz Portable and mobile RF communication devices should not be used closer to any part of the device than the 3V (valid value) recommended isolation distance, 150KHz~80mhz including cables. The distance is calculated by a formula corresponding to the transmitter frequency Recommended Isolation Distance D = 1.2
(P 150KHz-80MHz
) D = 1.2
(P 80MHz-800MHz
) RF radiation 3V/m 80MHz~2.5GHz 3V/m 18 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. Interference may occur near devices that mark the following symbols 1: 80MHz On the 800MHz frequency, the formula of higher frequency band is used. Note 2: In these guidelines may not be suitable for all cases, electromagnetic transmission is affected by the absorption and reflection of buildings, objects and the human body. A fixed-type transmitters, such as base stations for wireless (cellular/cordless) telephones and ground mobile radios, amateur radios, amplitude modulation and FM radio broadcasts, and television broadcasts, are theoretically not accurately predictable in their field strength. In order to evaluate the electromagnetic environment of fixed RF transmitter, the survey of electromagnetic site should be considered. If the measured field strength near TEA Device is higher than the above applicable RF compliance level, you should observe TEA Device to verify that it is functioning properly. If abnormal performance is observed, additional measures may be necessary, such as resizing or position the device. b in 150khz~80mhz the entire frequency range, the field strength should be lower than 3v/m. 19 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. According to the maximum rated output of communication equipment Rate TEA Device users can maintain portable and mobile RF communication equipment (transmitters) and TEA Device to prevent electromagnetic interference by the minimum distance between Maximum Isolation distance of different frequencies of the corresponding transmitter/m Transmitter Amount 150KHz-80MHz 80MHz-800MHz 800MHz-2.5GHz Fixed output power D = 1.2
)
(P D = 1.2
)
(P D = 2.3
)
(P W 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For the maximum rated output power of the transmitter not listed in the table above, the isolation distance d, in meters (m), is recommended and can be determined by the formula in the corresponding transmitter frequency bar. Note 1:from 80MHz to 800MHz Frequency onFormulas with higher frequency bands should be used Note 2:These guidelines may not be suitable for all situationsElectromagnetic propagation is influenced by the absorption and reflection of buildings, objects and the human body. 20 Chapter 4: Fault analysis and troubleshooting The specific exclusion method is prompted by the following table:
Fault TEA Cause analysis Exclusion method Device Battery charge is Please follow the instructions to Stimulator Charging And try to Unable to start empty start again. Hardware failure Please set TEA Device return to the original maintenance. TEA Device no Electrode line failure Please replace the electrode line. output Stimulus intensity is Please check TEA Device in stimulation mode, and stimulus too low strength is set within the range of sensations. Electrode Plate Please replace the electrode sheet. Damage Hardware failure As mentioned above, method invalid, please set TEA Device Return to the original maintenance. Battery module USB power adapter Please contact the after-sales department for replacement of the cannot charged be failure USB power adapter. USB charging cable Please contact the after-sales department for replacement of the failure USB charging cable. Battery aging Battery over service life, please contact after-sales department for return of the TEA Device. Hardware failure Please contact the after-sales department for return to replace the TEA Device Bluetooth device Bluetooth devices, Please download and install the correct TEA App. cannot connect such as phones, do TEA Device not properly install the correct version of the app software. Bluetooth devices, Please refer to the system requirements List of mobile phone such as mobile configuration requirements to replace the phone. phones, do not 21 support software app Bluetooth devices, Go to the Bluetooth Device Settings page and authorize the app such as mobile software to use the Bluetooth module. phones, are not set up correctly and authorize TEA app to use Bluetooth modules. Bluetooth Devices Please reduce the distance between TEA Device and the and TEA Device are Bluetooth device (phone). Try the connection again. too far away from each other. Bluetooth device Please restart TEA Device and Bluetooth device (phone), keep a and/or TEA Device close distance and try connecting again. Software failure. The cause of If the aforementioned means are invalid, please set TEA Device to hardware failure of Return to the original maintenance. product communication. 22 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. A place of high temperature, humidity, non-ventilation, direct sunlight, dust, or salty air. A place where it can produce tilt, vibration, or shock. Chemical storage sites and places where corrosive gases are produced
"Note" If you do not comply with the above precautions and other correct use methods, the company does not assume quality responsibility. Users are not allowed to repair TEA Device. For repairs, sent to the manufacturer or a designated franchise distributor. 5.2 Waste Disposal TEA Device does not produce any waste during normal use. TEA Device and its accessories can be treated as electronic medical products in accordance with relevant national environmental protection requirements for treatment and waste disposal. 23 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. Within that period, the manufacturer will replace your faulty TEA Device at no charge (except shipping
& handling fees), provided that the device:
has been used for the intended purpose and in the manner described in this manual has not been connected to an unsuitable power source has not been subjected to misuse or neglect has not been modified or disassembled has not been damaged by accidental fall Legal rights are not affected by this warranty. To request the warranty service, please bring this product to the store or send it directly to manufacturer. 24 Chapter 7: Technical Specifications Name Model Power supply Power Battery type Charging Input Battery life Stimulation Stimulation Channels Stimulation waveform Stimulation mode Voltage compliance Maximum output current Current or voltage regulation Stimulation pulse width range Stimulation frequency range Electrode pad physical specifications Type Shape and size TEA Device physical specifications Dimensions Weight Housing Environment Transcutaneous Electrical Acustimulator (TEA) SNM-FDC01 Internal battery Rechargeable 3.7V Lithium-Polymer Battery 650 mAh 5V through USB 2.0 (custom USB charging cable is included) 300 Charge Cycles (80% Nominal capacity) 1 Rectangular alternating Continuous, Burst 65 V 9.5 mA Current regulation 50 500s 1 100 Hz Self-adhesive (single-patient, multiple applications) Round, diameter 20 mm 65 x 49 x 17 mm 44 g ABS plastic Operating/storage/transport temperature 5 to 40 Operating/storage/transport humidity Storage/transport atmospheric pressure Electric shock IP Rating Classification of safety levels 25% to 80% RH 70 to 106 kPa Internally Powered Equipment, type BF Applied Parts IpX2 Not suitable for is in the presence of flammable mixturesNo Ap/apg Continuous Operation Group 1, Class B Android 6.0 (or later) smart phone with Bluetooth 4.0 (or higher) Not supported Running mode EMC Smart phone compatibility Google Android Apple iOS 25 Description Chapter 8: Applied Standards Standard number IEC 60601-1:
2005+A1:2012 IEC 60601-1-2: 2014 IEC 60601-1-6:
2010+A1:2013 Collateral standard: Usability General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbances - Requirements and tests IEC 60601-1-11: 2015 IEC 60601-2-10: 2012 IEC 62133-2: 2017 IEC 62304:
2006+A1:2015 ISO 15223-1: 2016 ANSI/AAMI EC12:
2000/(R)2015 FCC 47 CFR Part 15 Subpart C ISO 10993-5:
2009/(R)2014 ISO 10993-10:
2010/(R)2014 ISO 14971: 2007 Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in homecare environment Particular requirements for the basic safety and essential performance of nerve and muscle stimulators Secondary cells and batteries containing alkaline or other non-acid electrolytes Medical device software - Software life cycle processes Symbols to be used with medical devices labels, labeling and information to be supplied Disposable ECG Electrodes Radio Frequency Devices: Intentional Radiators Biological Evaluation of Medical Devices: Tests for in vitro cytotoxicity Biological Evaluation of Medical Devices: Tests for irritation and skin sensitization Application of Risk Management to Medical Devices 26 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 users authority to operate the equipment. Note: This product 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 product 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 product 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. 27 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.com 28
1 | Internal Photos | Internal Photos | 645.81 KiB | July 26 2019 |
SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 1 of 5 Internal Photos Ningbo Medkinetic Medical Device Co., LTD. Lushan West Road 167-8, Ningbo Free Trade Zone (South), Ningbo Applicant:
Address of Applicant:
Equipment Under Test (EUT):
Product Name:
Model No.:
Transcutaneous Electrical Acustimulator SNM-FDC01 Page 1 of 5 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 2 of 5 Page 2 of 5 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 3 of 5 Page 3 of 5 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 4 of 5 Page 4 of 5 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 5 of 5 End Page 5 of 5
1 | External Photo | External Photos | 526.69 KiB | July 26 2019 |
SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 1 of 6 External Photos Ningbo Medkinetic Medical Device Co., LTD. Lushan West Road 167-8, Ningbo Free Trade Zone (South), Ningbo Applicant:
Address of Applicant:
Equipment Under Test (EUT):
Product Name:
Model No.:
Transcutaneous Electrical Acustimulator SNM-FDC01 Page 1 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 2 of 6 Page 2 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 3 of 6 Page 3 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 4 of 6 Page 4 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 5 of 6 Page 5 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Page: 6 of 6 End Page 6 of 6
1 | Confidentiality Letter | Cover Letter(s) | 140.36 KiB | July 26 2019 |
Mediinetic TRUBIA BT Mee To: SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia United States From: Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road, 167-8, Ningbo Free Trade Zone(South), Ningbo, Zhejiang Province Regarding: Confidentiality Request regarding application for FCC ID :2ATA8&- SNM-FDCO1 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commission's rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. Sincerely, Signature: Dhan We Printed Name : Zhang Wei Title: Quality Manager Company Name: Ningbo MedkKinetic Medical Device Co., Ltd.
1 | Power of Attorney Letter | Cover Letter(s) | 169.02 KiB | July 26 2019 |
MedHinetic TiRUDABT Maal Date: 20790513 TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: FCC ID: 2ATA8- SNM-FDCO1 To whom it may concern:
We, the undersigned, hereby authorize Parlam Zhan to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, | acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Ningbo MedKinetic Medical Device Co., Ltd.. This authorization is valid until further written notice from the applicant. Name (Printed):Zhang Wei Title:Quality Manager Signature: Lher9 We;
On behalf of Company: Ningbo MedkKinetic Medical Device Co., Ltd. Telephone:08657486808886
1 | RF exposure Info | RF Exposure Info | 462.37 KiB | July 26 2019 |
SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Report No.: SHEM190401210102 Page: 1 of 7 1 Cover Page RF Exposure REPORT SHEM1904012101CR 2ATA8-SNM-FDC01 Ningbo Medkinetic Medical Device Co., LTD. Lushan West Road 167-8, Ningbo Free Trade Zone (South), Ningbo Ningbo Medkinetic Medical Device Co., LTD. Application No.:
FCC ID:
Applicant:
Address of Applicant:
Manufacturer:
Address of Manufacturer: Lushan West Road 167-8, Ningbo Free Trade Zone (South), Ningbo Factory:
Address of Factory:
Equipment Under Test (EUT):
EUT Name:
Model No.:
Trade mark:
Standard(s) :
Ningbo Medkinetic Medical Device Co., LTD. Lushan West Road 167-8, Ningbo Free Trade Zone (South), Ningbo Transcutaneous Electrical Acustimulator SNM-FDC01 Jorjin FCC Rules 47 CFR 2.1093 KDB447498 D01 General RF Exposure Guidance v06 2019-04-04 2019-04-23 to 2019-04-27 2019-04-30 Pass*
Date of Receipt:
Date of Test:
Date of Issue:
Test Result:
* In the configuration tested, the EUT complied with the standards specified above. Parlam Zhan E&E Section Manager The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. If the product in this report is used in any configuration other than that detailed in the report, the manufacturer must ensure the new system complies with all relevant standards. Any mention of SGS International Electrical Approvals or testing done by SGS International Electrical Approvals in connection with, distribution or use of the product described in this report must be approved by SGS International Electrical Approvals in writing. SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Report No.: SHEM190401210102 Page: 2 of 7 Version Description Revision Record Date Original 2019-04-30 00 Authorized for issue by:
Bill Wu / Project Engineer Parlam Zhan / Reviewer Remark
SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Report No.: SHEM190401210102 Page: 3 of 7 2 Contents 1 2 3 Page COVER PAGE ................................................................................................................................................. 1 CONTENTS ..................................................................................................................................................... 3 GENERAL INFORMATION ......................................................................................................................... 4 3.1 GENERAL DESCRIPTION OF E.U.T. ................................................................................................................ 4 3.2 DETAILS OF E.U.T. ....................................................................................................................................... 4 3.3 TEST LOCATION ............................................................................................................................................. 5 3.4 TEST FACILITY ............................................................................................................................................... 5 TEST STANDARDS AND LIMITS .............................................................................................................. 6 4.1 FCC RADIOFREQUENCY RADIATION EXPOSURE LIMITS .................................................................................. 6 5 MEASUREMENT AND CALCULATION ................................................................................................... 7 5.1 MAXIMUM TRANSMIT POWER ........................................................................................................................ 7 5.2 RF EXPOSURE CALCULATION ........................................................................................................................ 7 4 SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Report No.: SHEM190401210102 Page: 4 of 7 3 General Information 3.1 General Description of E.U.T. Power supply:
Test voltage:
Cable:
3.2 Details of E.U.T. Bluetooth Version Antenna Gain Antenna Type Channel Spacing Modulation Type Number of Channels Operation Frequency DC 3.7V 650mAh rechargeable Li-ion battery Charging adapter ModelQLC181000CU-A1000-CCC Input:100-240V 50/60Hz Output:5V 1000mA DC 3.7V USB Cable:80cm Bluetooth 4.2 3.51dBi Ceramic Antenna 2MHz GFSK 40 2402MHz to 2480MHz SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Report No.: SHEM190401210102 Page: 5 of 7 3.3 Test Location All tests were performed at:
SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch 588 West Jindu Road, Xinqiao, Songjiang, 201612 Shanghai, China. Tel: +86 21 6191 5666 Fax: +86 21 6191 5678 3.4 Test Facility The test facility is recognized, certified, or accredited by the following organizations:
CNAS (No. CNAS L0599) CNAS has accredited SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. to ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories
(CNAS-CL01 Accreditation Criteria for the Competence of Testing and Calibration Laboratories) for the competence in the field of testing. NVLAP (Certificate No. 201034-0) SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. is accredited by the National Voluntary Laboratory Accreditation Program(NVLAP). Certificate No. 201034-0. FCC Designation Number: CN5033 SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. has been recognized as an accredited testing laboratory. Designation Number: CN5033. Test Firm Registration Number: 479755. Innovation, Science and Economic Development Canada SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. EMC Laboratory has been recognized by ISED as an accredited testing laboratory. IC Registration No.: 8617A-1. CAB identifier: CN0020. VCCI (Member No.: 3061) The 3m Semi-anechoic chamber and Shielded Room of SGS-CSTC Standards Technical Services
(Shanghai) Co., Ltd. has been registered in accordance with the Regulations for Voluntary Control Measures with Registration No.: R-13868, C-14336, T-12221, G-10830 respectively. SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Report No.: SHEM190401210102 Page: 6 of 7 4 Test Standards and Limits 4.1 FCC Radiofrequency radiation exposure limits The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances 50 mm are determined by:
[(max power of channel)/(min test separation distance)]*[f(GHz)] 3.0 for 1-g SAR and 7.5 for 10-
g extremity SAR, where f(GHz) is the RF channel transmit frequency in GHz Power and distance are rounded to the nearest mW and mm The result is rounded to one decimal place for comparison 3.0 and 7.5 are referred to as the numeric thresholds The test exclusions are applicable only when the minimum test separation distance is 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 4.1 f) is applied to determine SAR test exclusion. For 2.4G band device, the limit of worse case is Pmax7.5*Dmin)/
f =7.5*5/ 2.480 =23.810mW SGS-CSTC Standards Technical Services Co., Ltd. Shanghai Branch Report No.: SHEM190401210102 Page: 7 of 7 5 Measurement and Calculation 5.1 Maximum transmit power The Power Data is based on the RF Test Report SHEM190401210101. Output Power Test Frequency Test Mode BLE
(MHz) 2402 2442 2480
(dBm)
-7.09
-5.79
-5.45 Reading Power
(mW) 0.20 0.26 0.29 5.2 RF Exposure Calculation The Max Conducted Peak Output Power is 0.29mW. The best case gain of the antenna is 3.51dBi. 3.51dBi logarithmic terms convert to numeric result is nearly 2.24 According to the formula. calculate the EIRP test result:
EIRP= P x G = 0.29 mW x 2.24 = 0.65mW < 23.810mW So the SAR report is not required.
--End of the Report--
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-07-26 | 2402 ~ PowerOutput | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-07-26
|
||||
1 | Applicant's complete, legal business name |
Ningbo Medkinetic Medical Device Co.,Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0028472686
|
||||
1 | Physical Address |
LushanWestRoad167-8,Ningbo Free Trade Zone(South)
|
||||
1 |
Ningbo,Zhejiang province, 315806
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
u******@sgs.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ATA8
|
||||
1 | Equipment Product Code |
SNM-FDC01
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
Z**** W****
|
||||
1 | Telephone Number |
08657********
|
||||
1 | Fax Number |
08657********
|
||||
1 |
z******@medkinetic.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
1 | Name |
P**** Z******
|
||||
1 | Physical Address |
588 West Jindu Road, Xinqiao, Songjiang
|
||||
1 |
ShangHai, 201612
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
86 21********
|
||||
1 | Fax Number |
86 21********
|
||||
1 |
P******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Transcutaneous Electrical Acustimulator | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power Output listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co.,Ltd.
|
||||
1 | Name |
L******** Y****
|
||||
1 | Telephone Number |
+86 (********
|
||||
1 |
l******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0003000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC