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Linktop HC-21, User Manual, Page: 12 / 17

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Linktop HC-21 User Manual Download Page 12

File No.: QR-HC21-C-C09

Xiamen Linktop Technology Co., Ltd.

Page 12 of 17

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

℃

5

Temperature limit

15.

Keep away from sunlight

16.

Keep away from rain

17.

Do not use if package is damaged

18.

Class II equipment

19.

Humidity limitation

20.

Fragile; handle with care

21.

Use by date

22.

Symbol for "IMPORTER". This symbol shall be accompanied by
the name and the address of the importer, adjacent to the symbol.

Summary of Contents for HC-21

Page 1: ...File No QR HC21 C C09 Xiamen Linktop Technology Co Ltd Page 1 of 17 Electronic Stethoscope Model HC 21 Xiamen Linktop Technology Co Ltd User Manual Version A 0 ...

Page 2: ... 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 Stet...

Page 3: ...ed 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 examinati...

Page 4: ...e 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 ...

Page 5: ...mponents 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 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 dustproo...

Page 6: ...Membrane diameter 1 7 inches 43 8 mm Weight 62g Battery life More than 500 charging cycles Frequency range RF ISM 2 402 2 480GHz Attenuation 100Hz 500Hz 12dB 600Hz 1000Hz 20dB Modulation GFSK RF power 4 5 dBm Bluetooth version Bluetooth 5 0 Type of application parts applied BF Protection class IP22 3 USING INSTRUCTIONS 3 1 Preparations for use 3 1 1 Application Prior to using the stethoscope it is...

Page 7: ...requirements described in this manual After connecting the stethoscope to the charger it should be left until 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 1 Use the application to connect with Electronic Stethoscope via Blue...

Page 8: ... 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 confir...

Page 9: ...ng 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 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 ...

Page 10: ...intended for medical products Please take care not to flood the 3 5 mm jack socket with the 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 5 STORAGE TRANSPORT AND OPERATION CONDITIONS 5 1 Storage and transport conditions Temperature 20 C do 60 C Relative hum...

Page 11: ...dress 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 9 PACKAGE CONTENTS 1 Electronic Stethoscope 1 2 User manual 1 3 Magnetic USB char...

Page 12: ... the essential health and safety requirements set out in European Directives 11 Atmospheric pressure limitation 12 Batch code 13 Catalogue number 14 40 5 Temperature limit 15 Keep away from sunlight 16 Keep away from rain 17 Do not use if package is damaged 18 Class II equipment 19 Humidity limitation 20 Fragile handle with care 21 Use by date 22 Symbol for IMPORTER This symbol shall be accompanie...

Page 13: ...Electronic Stethoscope should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Electronic Stethoscope use RF energy only 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 Electroni...

Page 14: ...UT for 5 sec Not applicable Battery operated device Mains power quality should be that of a typical commercial or hospital environment If the user of the Electronic Stethoscope requires continued operation during power mains interruptions it is recommended that the Electronic Stethoscope be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 ...

Page 15: ...gths form fixed RF transmitters as determined by an electromagnetic site survey a should be 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 ...

Page 16: ...50kHz to 80 MHz filed strengths should be less than 3V m Recommended separation distances between portable and mobile Test Frequency MHz Band MHz Service Modulation Maximum Power W Distance m Immunity Test Level V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 KHz deviation 1KHz sine 2 0 3 28 710 704 787 LTE 13 17 Band Pulse modulation 217 Hz 0 2 0 3 9 ...

Page 17: ...3 9 5500 5785 12 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 Xiamen Linktop Technology Co Ltd Address Room 501 2 502 503 North Building ...

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