Fudakang FTC11BBT Arm type Blood pressure monitor User Manual Rev
Fudakang Industrial Co., LTD Arm type Blood pressure monitor Rev
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![STATEMENTS AND DECLARATIONS: 1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS 2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from the equipment. (Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m) 3. The manufacturer are available for request of circuit diagrams, component part lists, descriptions ,calibration instructions ,or other information that will assist service personnel to repair those parts of the device 4. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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 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. 5. Guidance and manufacturer’s delclaration Guidance and manufacture’s declaration – electromagnetic emission The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The customer of the user of the [EQUIPMENT or SYSTEM] should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment –](https://usermanual.wiki/Fudakang/FTC11BBT/User-Guide-2490502-Page-19.png)
![guidance RF emissions CISPR 11 Group 1 The [EQUIPMENT or SYSTEM] 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 emission CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable Guidance and manufacture’s declaration – electromagnetic immunity The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The customer or the user of [EQUIPMENT or SYSTEM] should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. If ESD interfere with the operation of equipment ,counter measurements such as wrist strap, grounding shall be considered. Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV differential mode. ±2 kV common mode Not applicable Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) Not applicable Mains power quality should be that of a typical commercial or hospital environment. If the user of the TL-100Drequires continued operation during power mains interruptions, it is recommended that the TL-100Dbe powered from an uninterruptible power supply](https://usermanual.wiki/Fudakang/FTC11BBT/User-Guide-2490502-Page-20.png)
![for 25 cycles <5% UT (>95% dip in UT) for 5 sec or a battery. Power frequency (50Hz) magnetic field IEC 61000-4-8 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacture’s declaration – electromagnetic immunity The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The customer or the user of [EQUIPMENT or SYSTEM] should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz Not applicable Portable and mobile RF communications equipment should be used no closer to any part of the [EQUIPMENT or SYSTEM], including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Pd 167.1= Pd 167.1= 80 MHz to 800 MHz Pd 333.2= 800 MHz to 2.5 GHz 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 metres (m). Field strengths from 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: Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land](https://usermanual.wiki/Fudakang/FTC11BBT/User-Guide-2490502-Page-21.png)
![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 field strength in the location in which the [EQUIPMENT or SYSTEM] is used exceeds the applicable RF compliance level above, the [EQUIPMENT or SYSTEM] should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the [EQUIPMENT or SYSTEM]. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the [EQUIPMENT or SYSTEM]. The [EQUIPMENT or SYSTEM] is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the [EQUIPMENT or SYSTEM] can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the [EQUIPMENT or SYSTEM] as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 KHz to 80 MHz Pd 167.1= 80 MHz to 800 MHz Pd 167.1= 800 MHz to 2.5 GHz Pd 333.2= 0.01 0.117 0.117 0.233 0.1 0.369 0.369 0.738 1 1.167 1.167 2.333 10 3.689 3.689 7.379 100 11.667 11.667 23.333 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. FCC ID: 2ADNQFTC11BBT 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.](https://usermanual.wiki/Fudakang/FTC11BBT/User-Guide-2490502-Page-22.png)
