User Manual for LINKTOP models including: HC21, 2A2J3-HC21, 2A2J3HC21, HC-21 Electronic Stethoscope, HC-21, Electronic Stethoscope, Stethoscope
Xiamen Linktop Technology Co., Ltd. HC21 2A2J3-HC21 2A2J3HC21 hc21
File Info : application/pdf, 21 Pages, 923.74KB
DocumentDocumentFile No.: QR-HC21-C-F09 Electronic Stethoscope (Model: HC-21) Xiamen Linktop TechnologyCo., Ltd. User Manual (Version: A/0) Xiamen Linktop Technology Co., Ltd. Page 1 of 21 File No.: QR-HC21-C-F09 Foreword This manual is a part of a medical product - the Electronic Stethoscope. Linktop bears no liability and provides no guarantee with regard to damage (including indirect damage) arising due to this user manual not being complied with. Prior to using the medical product, it is required to read this user manual carefully. The user manual should be kept in a safe place for the whole duration of using the medical product. It should be provided to every subsequent owner or user of this medical product. It should be updated on the basis of every supplementation received from the product manufacturer. The aim of this manual is to describe a medical product the Electronic Stethoscope taking into account the following in particular: Description of the medical product, Safety of use, Maintenance, Troubleshooting, Servicing. Xiamen Linktop Technology Co., Ltd. Page 2 of 21 File No.: QR-HC21-C-F09 1. SAFETY GUIDE Please read the entire instruction manual before you use Electronic Stethoscope. It will give you a better understanding of how the product works. 1.1 Warnings Using this medical product is not the substitution for visiting a physician and patient may not delay obtaining medical assistance in sudden pathological conditions. This medical product can be operated by adults only. Do not perform auscultation with this medical product if there are any wounds or abrasions within the spot examined. In the event that the user of this medical product has a pacemaker implanted, he or she should consult with a physician for the admissibility of using this medical product. The device is sensitive to external factors - noises or murmurs may have a negative impact on the quality of recordings. This medical product is not intended for diagnostics in emergency conditions! If you suspect any hazard to life or health (e.g. trouble breathing, impaired consciousness, significantly increased respiratory rate, panic), do not use this medical product! In such a situation, contact a doctor urgently. This medical product includes small elements that can be ingested or aspirated: keep the product and its accessories away from children. The power supply cable may constitute a strangulation hazard: any examination of children should be conducted under supervision. Only Magnetic USB cable paired with a charger provided by the manufacturer or a charger with parameters consistent with those specified in this manual should be used for charging the device. Do not perform examinations with the stethoscope or put it to the body while it is being charged. Do not attempt to replace the battery on your own,it can be only replaced by the manufacturer. Replaced by inadequately trained personnel may result the device can't work or work abnormally. Prior to commencing examination, please disconnect the charging cable from the stethoscope! In case of noticing any irregularities in functioning of the stethoscope or any damage to it, stop using it immediately and contact the manufacturer. Prior to using the stethoscope, make sure that it has no visible damage. The stethoscope should not be opened or modified. The stethoscope should not be immersed in water or other liquids. All parts of the subject device that are not serviced or maintained while in use with the patient. All components of the subject device can not be repaired or replaced by the end user. Except that the membrane, audio jack silicone plug and magnetic USB cable are allowed to be replaced by the designated maintenance outlets. Other repairs and replacements can be only done by the manufacturer. Do not use corrosive disinfectant. If the device is corroded, please stop using the device. Xiamen Linktop Technology Co., Ltd. Page 3 of 21 File No.: QR-HC21-C-F09 1.2 Precautions This medical product is an electronic stethoscope. It should be used solely for recording the respiratory system or heart auscultation sounds. This medical product does not analyze the sounds recorded. A recording made using this medical product may be transmitted only via applications approved by Linktop. The recordings made using any applications other than those specified below may not be reliable, which may lead to their content being interpreted incorrectly by a doctor and, in consequence, to incorrect diagnosis. The list of approved applications is available at the www.linktop.com website. Do not expose the product to any chemical substances, sunlight, or high temperature. Protect the stethoscope against shocks and falls. The product should be used in ambient temperature from 5 to 40. Do not expose the stethoscope to temperatures greater than 50 or lower than 0. Do not use the product when the relative humidity exceeds 90%. In case of noticing any irregularities in functioning of the stethoscope or any damage to it, stop using it immediately and contact the manufacturer.The product should be stored in a clean and dry place. This medical product is not sterile and must not be sterilized. The stethoscope should be charged only by means of the charging cable included in the set supplied.The charging cable is 1 meter and satisfied with UL758. In any other case, use a charger that meets the requirements described of this manual. When the product is being charged, all its functions, including data transmission, are blocked. The stethoscope does not include any parts that can be replaced by the user on their own. If you experience any skin irritation or redness after use this device, please stop using the device. 1.3 Contraindications N/A 1.4 Adverse Reactions N/A 1.5 Special Population N/A 1.6 Intended Use/Indications for Use The Electronic Stethoscope is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest with selective frequency ranges. It can be used on any person undergoing a physical examination. Xiamen Linktop Technology Co., Ltd. Page 4 of 21 File No.: QR-HC21-C-F09 2. DEVICE DESCRIPTION 2.1 General Description Electronic stethoscope's proprietary environmental noise cancellation technology can help you hear the human body's important heart and lung sounds. This technology can reduce background noise by an average of 85%, but will not filter out important auscultation sounds. Electronic stethoscope is compatible with both headset auscultation and Bluetooth recording auscultation, which is convenient for doctors in clinical diagnosis or remote auscultation. The excellent acoustic sensitivity and high-quality sound transmission of this product provide reliable performance and comfortable experience for medical professionals who are committed to achieving the best patient care. 2.2 Device Drawing Figure 1. Device Drawing 2.3 Device Components The main elements of the stethoscope are presented on Figure 2. Figure 2. Device Components Description of each component Power button: Power on/off and Bluetooth pairing Button. Indicator light: Two color LEDs PC socket: 3.5 mm mini jack socket used for connecting PC or Mobile phone to record Xiamen Linktop Technology Co., Ltd. Page 5 of 21 File No.: QR-HC21-C-F09 Charge port: Magnetic USB interface used for charging Headphones socket: 3.5 mm mini jack socket used for connecting headphones Membrane Audio jack silicone plug used for waterproof and dustproof of the audio jack. The table below includes the description of the Button and LEDs on the stethoscope: In the shutdown state, Long press the button 3 seconds to turn on In the power-on state, Long press the button 3 seconds to power off In the working mode, short press the button to enter sleep mode In the working mode, double press the button to switch auscultation mode (heart sound auscultation and lung sound auscultation mode) Green light is always on in lung sound auscultation mode when Bluetooth connected Green light flashes slowly when charging Green light is always on when fully charged Blue light is always on in heart sound auscultation mode when Bluetooth connected 2.4 Specifications Product Name Model Power supply Dimensions Weight Battery Battery life Frequency range Attenuation Modulation RF power Bluetooth version Type of application parts applied Electronic Stethoscope HC-21 5V DC 500mA (lithium-ion battery) Height 1.02 inches (26mm) Base diameter 1.77 inches (45 mm) Membrane diameter 1.7 inches (43.8 mm) 62g 3.7V 200mAh 0.74W More than 500 charging cycles RF: ISM, 2.402-2.480GHz 100Hz-500Hz 12dB 600Hz-1000Hz 20dB GFSK 4.5 dBm Bluetooth 5.0(Only supports Bluetooth Low Energy mode, does not support the Classic Bluetooth; the advantages of BLE are low power consumption, fast connection and security, and long transmission distance; Electronic Stethoscope is a slave Bluetooth device, which can be discovered by the master device such as the mobile phone of the mobile device , it through broadcasting ,then be connected by mobile device) BF Xiamen Linktop Technology Co., Ltd. Page 6 of 21 File No.: QR-HC21-C-F09 Applied part Protection class Mode of operation Protection against electric shock Silicon cover (Membrane) IP22 Continuous Operation Internally Powered Me Equipment 3. USING INSTRUCTIONS Adult patient can be an intended operator. They can operate the steps mentioned in this chapter. 3.1 Preparations for use 3.1.1 Application Prior to using the stethoscope, it is necessary to confirm whether your mobile phone is supported by stethoscope. The available mobile phones are as follows: (1) Mobile phone or tablet with Android 7.0 or higher and Bluetooth 4.2, (2) iPhone that supports Bluetooth 4.2, such as: iPhone 7 / 7 Plus / 8 / 8 Plus / X / XR / Xs / Xs Max / 11 pro / 11 pro Max / 12 mini / 12 / 12 pro / 12 pro Max. Note: Always use the most recent version of the application ("NexStetho" application). You can download it from Official website: https://www.linktop.com, Google Play or App Store. 1. NexStetho application APK can be attacked by malware: Due to the possible system vulnerabilities of Android/iOS, the NexStetho application may be attacked by third-party malware. End users need to download the application through normal channels such as GooglePlay/APP Store, and Upgrade the system in time . 2. The possible problems of the device and NexStetho application through Bluetooth wireless connection: due to some loopholes in the Bluetooth connection itself, such as Just Work mode, explicit MAC address, weak endto-end security, etc., data may be intercepted by a third party, when the end user is not in use, please turn off the device , please do not use third-party software to try to connect to the device. 3. Since possible updates of the system software (Android/iOS) of the mobile device will affect the connection with the electronic stethoscope, and the mobile device hardware is also being updated all the time, there may be compatibility issues between the electronic stethoscope and the mobile device. Please pay attention to the updates of the NexStetho application for electronic stethoscopes and the update of the firmware of electronic stethoscopes. 4. For some reasons, the connection between the electronic stethoscope and the master device(Mobile phone) may fail, and the NexStetho application will not work normally; the connection between the electronic stethoscope and the master device may be unstable, the audio data will be incomplete or the remote control device fails. In these cases, please refer to TROUBLE SHOOTING to exclude possible causes. Xiamen Linktop Technology Co., Ltd. Page 7 of 21 File No.: QR-HC21-C-F09 3.1.2 Electronic Stethoscope (1) When using the stethoscope for the first time, long press the power button 3 seconds to power on. (2) If the battery of the device is low, it will not be able to start up. Connect the magnetic cable included in the set to the charging interface of the stethoscope to charge it (Figure 3) and remove it after it is fully charged. Figure 3. Charging demo Note: When the battery of the stethoscope is charged, the green LED is flashing, When the green LED is always on, means fully charged, you can disconnect the cable. (3) In order to charge the stethoscope, it is necessary to connect it to a charger using only the cable provided. In any other case the cable should be connected to a charger which satisfies with the regulation IEC 60601-1 or IEC6368-1 or equivalent standard. After connecting the stethoscope to the charger, it is suggested that it should be left until the stethoscope is fully charged (when the charging LED is always on). Note: When the stethoscope is being charged, all its function is blocked. 3.1.3 Activities during operation The stethoscope can be used in one of the three modes listed below: Use the application to connect with Electronic Stethoscope via Bluetooth. Use the application to connect with Electronic Stethoscope via 3.5mm audio cable. Use headphones to connect stethoscope for auscultation. When recording, make sure that the jack socket is not covered and do not knock on the casing. After putting the stethoscope to the body, click [Start] button to start recording on the application, and the application will show information on the recording progress. 1. Patient auscultation mode using the application to connect with Electronic Stethoscope via Bluetooth Xiamen Linktop Technology Co., Ltd. Page 8 of 21 File No.: QR-HC21-C-F09 (1) Use an Android phone to download the "NexStetho" application from Google Play or use an iPhone to download the "NexStetho" application from the APP Store. (2) Please make sure that the Bluetooth of the mobile phone is open, and the stethoscope is turned on. (3) Launch the "NexStetho" application, click "Add Device", the application will search for the Bluetooth of the stethoscope until it finds a device with the Bluetooth name "HC-21", select and connect, the application will automatically bind the stethoscope. (4) Use the application to select the auscultation mode and confirm whether to use the heart sound auscultation or lung sound auscultation mode. The heart sound auscultation mode is suitable for low-frequency sounds in auscultation, such as the first heart sound, the second heart sound, the rumbling diastolic murmur of mitral valve stenosis, etc. When using it, touch the body surface to be checked lightly, but care should be taken to avoid body parts and Additional sound caused by skin friction. The lung sound auscultation mode is suitable for high-pitched sounds in auscultation, such as murmurs of aortic regurgitation, breathing sounds, bowel sounds, etc. When using it, touch the body surface to be inspected tightly. (5) Select the auscultation site and confirm whether to auscultate the lung or the heart. (6) Putting the stethoscope membrane (Figure 4) to the patient's body at specific spots indicated by the doctor, and holding it at each spot, click the start button in the application to record until the auscultation time is sufficient, click the stop button to end the recording. Figure 4 (7) It is recommended to record sound at all the spots indicated by the doctor. (8) If you hear that the quality of sound recorded at some spots is poor, it is necessary to repeat recording at those spots. 2. Patient auscultation mode using the application to connect with Electronic Stethoscope via 3.5mm audio cable Xiamen Linktop Technology Co., Ltd. Page 9 of 21 File No.: QR-HC21-C-F09 It is necessary to launch the Recording application, connect the stethoscope via 3.5mm mini jack cable. The stethoscope only supports connecting with Windows PC, and only supports recording APP: Voice Recorder. (1) Select the auscultation site and confirm whether to auscultate the lung or the heart. (2) Putting the stethoscope membrane (Figure 5) to the patient's body at specific spots indicated by the doctor, and holding it at each spot, click the start button in the application to record until the auscultation time is sufficient, click the stop button to end the recording. Figure 5 (3) It is recommended to record sound at all the spots indicated by the doctor. (4) If you hear that the quality of sound recorded at some spots is poor, it is necessary to repeat recording at those spots. Note: This package is not equipped with 3.5mm audio cable, if you want to use the 3.5mm audio cable, we will present 2 silicone sleeves, put them on at the 3.5mm plug ends, they will protect the stethoscope from electrostatic interference. Xiamen Linktop Technology Co., Ltd. Page 10 of 21 File No.: QR-HC21-C-F09 3. Patient auscultation mode using headphones to connect Electronic Stethoscope In this mode, no need to connect the application, it needs to connect headphones to the 3.5 mm mini jack socket. The stethoscope LED will show a blue flashing indicator that the heart auscultation filter is active. After double pressing the stethoscope button, the filter will be switched to the lung auscultation mode, the stethoscope LED will show a green flashing indicator. Although it is possible to use various type of headphones, in view of the range of frequencies present in auscultation sound signals and levels thereof it is recommended to use headphones with minimum impedance of 16 Ohm and bandwidth of at least 20 20KHz during auscultation. Note: This package is not equipped with a headphone, if you want to use a headphone, we will present a silicone sleeve, put it on at the 3.5mm plug end, it will protect the stethoscope from electrostatic interference. Xiamen Linktop Technology Co., Ltd. Page 11 of 21 File No.: QR-HC21-C-F09 3.1.4 Turning the stethoscope off If you do not use the stethoscope, you can press the stethoscope button to put it into sleep mode. It is not necessary to turn it off after each use. If it is necessary to turn off the stethoscope completely, it can be done by pressing and holding the stethoscope button for 3 seconds. To turn on the stethoscope again, it is enough to press and hold the stethoscope button for 3 seconds. Note: If the stethoscope is not turned off when it is not in use, the stethoscope may run out of battery power. CLEANING AND MAINTENANCE The stethoscope should be disinfected after each use. It should be disinfected using a cotton pad or swab moistened with alcoholic disinfectant intended for medical products. · Please take care not to flood the 3.5 mm jack socket with t he disinfectant. · Do not immerse the stethoscope in water or other cleaning liquids and do not clean it under running water. · Make sure that the water does not reach the inside of the stethoscope. · After the stethoscope is charged, it can be used continuously for 8h. When the battery is low, the green light will flash quickly, please charge the battery in time.If the battery hasn't been used for very long time and cause the stethoscope to fail to power on, please return the stethoscope to the manufacturer for repair. 4. STORAGE, TRANSPORT AND OPERATION CONDITIONS 4.1 Storage and transport conditions: Temperature: -20°C to 60°C Relative humidity: 10% to 95% Atmospheric pressure: 700 hPa ~1060 hPa 4.2 Operation conditions: Temperature: 5°C to 40°C Relative humidity: from 10% to 95% Atmospheric pressure: 700 hPa ~1060 hPa 5. TROUBLE SHOOTING Malfunctions Reason APP cannot connect to the device via Bluetooth Bluetooth is not in pairing state Solution The device enters sleep mode, short press the button to enter working mode. The device is turned off, long press the button for 3 seconds to turn on the device. Xiamen Linktop Technology Co., Ltd. Page 12 of 21 File No.: QR-HC21-C-F09 Incomplete sound transmission via Bluetooth Serious recording noise Wrong connection distance Keep the distance between the app and the device within 2 meters Bluetooth version is low Noise caused by skin friction Must use Bluetooth 4.2 or higher mobile phone or tablet Touch the body surface to be checked lightly, but care should be taken to avoid body parts and Additional sound caused by skin friction. 6. SERVICING In case of noticing any irregularities in functioning of the medical product, contact the maintenance service at the e-mail address: support@linktop.com Linktop bears no liability and provides no guarantee with regard to damage (including indirect damage) arising due to this user manual not being complied with. 7. WARRANTY The warranty-related information regarding warranty duration, its scope, its territorial range, and the rights in case of finding a defect are described in detail at the address: www.linktop.com . Note: The device and accessories out of shelf life or use life should not be thrown randomly and should be recycled by the manufacturer. To dispose of packing materials, take appropriate actions in accordance with the rules and regulations in force in your area to prevent adverse ecological effects. 8. PACKAGE CONTENTS (1) Electronic Stethoscope × 1 (2) User manual × 1 (3) Magnetic USB charging cable × 1 (4) Audio jack silicone plug x 2 9. LABEL SYMBOLS 1. Symbol for "MANUFACTURER". This symbol shall be accompanied by the name and the address of the manufacturer. 2. Serial number 3. DATE OF MANUFACTURE. This symbol shall be accompanied by a date to indicate the date of manufacture. 4. Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY". This symbol shall be accompanied by the name and the address of the authorized representative in the European Community, adjacent to the symbol. Xiamen Linktop Technology Co., Ltd. Page 13 of 21 File No.: QR-HC21-C-F09 5. Collect separately from other household waste 6. IP22 indicates protection against access to hazardous parts with a finger, solid objects12.5mm diameter, and vertically falling water drops when enclosure tilted up to 15degrees. 7. Refer to user manual 8. Type BF Applied Part 9. Symbol for "ATTENTION" Caution! Follow operating instructions! Failure to do so could place the patient or operator at risk. 10. Conformity indication with the essential health and safety requirements set out in European Directives. 11. Atmospheric pressure limitation 12. Batch code 13. Catalogue number 14. 40 Temperature limit 5 15. Keep away from sunlight 16. Keep away from rain 17. Do not use if package is damaged 18. Humidity limitation 19. Fragile; handle with care 20. Use by date Xiamen Linktop Technology Co., Ltd. Page 14 of 21 File No.: QR-HC21-C-F09 21. Symbol for "IMPORTER". This symbol shall be accompanied by the name and the address of the importer, adjacent to the symbol. 22. Unique device identifier 23. Medical device 10. ELECTROMAGNETIC COMPATIBILITY The Electronic Stethoscope has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. a) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in abnormal operation of the unit. b) Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation! c) Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used. Manufacturer's declaration electromagnetic emissions The Electronic Stethoscope is intended for use in the electromagnetic environments specified below. The customer or the user of the Electronic Stethoscope should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions The Electronic Stethoscope use RF energy only CISPR 11 Group 1 for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The Electronic Stethoscope is suitable for use in all establishments, including domestic Harmonic emissions IEC 61000-3-2 Not applicable establishments and those directly connected to the public low-voltage power supply network that Voltage function / supplies buildings used for domestic purposes. flicker emissions Not applicable IEC 61000-3-3 Xiamen Linktop Technology Co., Ltd. Page 15 of 21 File No.: QR-HC21-C-F09 Manufacturer's declaration electromagnetic immunity The Electronic Stethoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Electronic Stethoscope should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic ±8kV contact ±8kV contact Floors should be discharge (ESD) wood, concrete or IEC 61000-4-2 ±2, 4, 8, 15kV air ±2, 4, 8, 15kV air ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrostatic ±2kV for power Not applicable Mains power quality transient / burst supply lines (Battery operated should be that of a IEC 61000-4-4 ±1kV for input/output device) typical commercial lines or hospital environment. Surge ±1kV differential Not applicable Mains power quality IEC 61000-4-5 mode (Battery operated should be that of a ±2kV common mode device) typical commercial or hospital environment. Voltage dips, short Mains power quality interruptions and should be that of a voltage variations on power supply input lines <5% UT (>95% dip in UT) for 0.5 cycle typical commercial or hospital environment. If the user of the IEC 61000-4-11 40% UT (60% dip in UT) for 5 cycles Not applicable (Battery operated Electronic Stethoscope requires continued operation during 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% d i p in UT) for 5 sec device) power mains interruptions, it is recommended that the Electronic Stethoscope be powered from an uninterruptible power supply or a battery. Xiamen Linktop Technology Co., Ltd. Page 16 of 21 File No.: QR-HC21-C-F09 Power frequency 30 A/m 30 A/m Power frequency (50/60 Hz) magnetic magnetic fields field should be at levels characteristic of a IEC 61000-4-8 typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Manufacturer's declaration electromagnetic The Electronic Stethoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Electronic Stethoscope should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment - guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the Electronic Stethoscope, including cables, than the recommended Conducted RF 3Vrms Not applicable (Battery separation distance calculated from the equation application to the frequency of the transmitter. IEC 61000-4-6 150kHz to operated 80MHz device) Recommended separation distance Radiated RF IEC 61000-4-3 10V/m 80MHz to 2.7GHz 10V/m Xiamen Linktop Technology Co., Ltd. Where p is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in meter (m) Field strengths form fixed RF transmitters, as determined by an electromagnetic site survey, a should be Page 17 of 21 File No.: QR-HC21-C-F09 less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people. a Field strengths from transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured filed strength in the location in which the Electronic Stethoscope is used exceeds the applicable RF compliance level above. The Electronic Stethoscope should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Electronic Stethoscope. b Over the frequency range 150kHz to 80 MHz, filed strengths should be less than 3V/m. Recommended separation distances between portable and mobile Test Band Service Modulation Maximum DistanceImmunity Frequency (MHz) Power (W)(m) Test Level (MHz) (V/m) 385 380- TETRA 400 Pulse modulation 18 Hz 1.8 0.3 27 390 450 430- GMRS FM ±5 KHz 2 0.3 28 470 460, FRS deviation 1KHz sine 460 710 704- LTE 13, 17 Pulse modulation 217 Hz0.2 787 Band Xiamen Linktop Technology Co., Ltd. 0.3 9 Page 18 of 21 745 780 810 870 930 1720 1845 1970 File No.: QR-HC21-C-F09 800- GS M Pulse modulation 18 Hz 2 960 800/ 900, TETRA 800 , iDEN 820, CDMA 850, LTE 5 Band 1700- GSM 1800 , Pulse modulation 217 Hz2 1990 C D M A 1900, GSM 1900, DECT, LTE 1, 3, 4 , 25 Band, UMTS 0.3 28 0.3 28 2450 5240 5500 5785 2400- Bluetooth, Pulse modulation 217 Hz2 2570 WLAN 802.1 1 b/g/n, RFID 2450, LTE 7 Band 5100- WLAN Pulse modulation 217 Hz0.2 5800 802.11 a/n 0.3 28 0.3 9 Xiamen Linktop Technology Co., Ltd. Page 19 of 21 File No.: QR-HC21-C-F09 11. Statement Hereby, Xiamen Linktop Technology Co., Ltd., declares that this Electronic Stethoscope is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. The full test of the EU declaration of conformity is available at the following internet address: www.linktop.com 12. 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. NOTE: This equipment 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 equipment 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 equipment 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 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. WARNING: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. 13. Shelf life and expected service life The shelf life of the device and accessories is 3 years respectively. The expected service life of the device and accessories is 2 years respectively. Xiamen Linktop Technology Co., Ltd. Address: Room 501-2,502,503, North Building, Torch Hi-Tech Zone, No.56-58 Huoju Road, Xiamen, 361000, Fujian, P.R. China. Website: www.linktop.com Xiamen Linktop Technology Co., Ltd. Page 20 of 21 File No.: QR-HC21-C-F09 Nexvoo inc Address: 1702 W Michigan St Indianapolis, IN 46222 Product Name(s): Electronic Stethoscope Trade Name(s): Linktop Model Number(s): HC-21 Telephone: 886.910.8366 Website address: www.nexvoo.com Xiamen Linktop Technology Co., Ltd. Page 21 of 21