Boston Scientific Rotablator

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Guidance and manufacturer’s declaration - electromagnetic immunity

The Rotablator™ System is intended for use in the electromagnetic environment specified below. The customer or the user of the Rotablator 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

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2,5 GHz

3 V

3 V/m

Portable and mobile RF communications equipment should be used no closer to

any part of the Rotablator System, including cables, than the recommended

separation distance calculated from the equation applicable to the frequency of the

transmitter.

Recommended separation distance

d = 1,2 √P

d = 1,2 √P 80 MHz to 800 MHz

d = 2,3 √P 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 meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic

site survey

, should be less than the compliance level in each frequency range.

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 propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed 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 field strength in the location in which the Rotablator System is used exceeds the applicable RF

compliance level above, the Rotablator System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be

necessary, such as re-orienting or relocating the Rotablator System.

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 Rotablator System

The Rotablator System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the

Rotablator System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the Rotablator System as recommended below, according to the maximum output power of the communications equipment.

Rate Maximum Output Power of

Transmitter

Separation Distance According to Frequency of Transmitter

150 kHz to 80 MHz

d = 1,2 √P

80 MHz to 800 MHz

d = 1,2 √P

800 MHz to 2,5 GHz

d = 2,3 √P

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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.

Warranty

Boston Scientific Corporation (BSC) warrants that reasonable care has been

used in the design and manufacture of this instrument. This warranty is in lieu

of and excludes all other warranties not expressly set forth herein, whether

express or implied by operation of law or otherwise, including, but not

limited to, any implied warranties of merchantability or fitness for a

particular purpose. Handling, storage, cleaning and sterilization of this

instrument as well as other factors relating to the patient, diagnosis, treatment,

surgical procedures and other matters beyond BSC’s control directly affect the

instrument and the results obtained from its use. BSC’s obligation under this

warranty is limited to the repair or replacement of this instrument and BSC

shall not be liable for any incidental or consequential loss, damage or expense