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医療機器 Caldera Benesta CAL-TR1511のPDF 取扱説明書をオンラインで閲覧またはダウンロードできます。Caldera Benesta CAL-TR1511 7 ページ。 Tissue removal device

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Interconnections conditions require the applied parts of other medical

•

electrical equipment used within the configuration for hysteroscopic

application to be type BF applied parts or type CF applied parts

This equipment is designed and tested to minimize interference with

•

other electrical equipment. However, if interference occurs with other

equipment it may be corrected by one or more of the following

measures:

1. Reorient or relocate this equipment, the other equipment, or both.

2. Increase the separation between the pieces of equipment.

3. Connect the pieces of equipment into different outlets or circuits.

4. Consult a biomedical engineer. Electrical safety testing should be

performed by a trained biomedical engineer or other qualified

person.

It is the responsibility of the person(s) installing, utilizing and

•

decommissioning the Benesta

the electromagnetic environment does not exceed or deviate from the

specifications listed in Tables 1-4.

The following tables provide information on the electromagnetic

environment that the Benesta

operating in safely.

Table 1. Declaration of Electromagnetic Emissions

The Benesta

Tissue Removal Device is intended for use in the electromagnetic environment

specified below. The customer or the user of the Benesta

it is used in such an environment.

Test Level/

Emissions test

Limits

RF emissions CISPR 11 Class A

Harmonic distortion

Class A

IEC 61000-3-2

Voltage fluctuations/

Pst ≤1.0

flicker emissions

Plt ≤ 0.65

IEC 61000-3-3

dc ≤ 3.3%

dmax ≤4.0%

Tissue Removal Device to ensure that

Tissue Removal Device is capable of

Tissue Removal Device should assure that

Electromagnetic Environment / Recommendations

The EMISSIONS characteristics of this equipment make

it suitable for use in industrial areas and hospitals

(CISPR 11 class A). If it is used in a residential

environment (for which CISPR 11 class B is normally

required) this equipment might not offer adequate

protection to radio-frequency communication services.

The user might need to take mitigation measures, such

as relocating or re-orienting the equipment

Not Applicable - device is battery operated

Table 2. Declaration of Electromagnetic Immunity

Immunity Test

Electrostatic

8 kV (±) Contact

Discharge (ESD)

15 kV (±) Air

IEC 61000-4-2

Electrical Fast

±2 kV AC/DC power supply

Transients

±1 kV input/output lines

IEC 61000-4-4

Surge

±1 kV to line(s)

IEC 61000-4-5

±2 kV to line(s) to earth

Radio Frequency

3 Vms

(RF) Common Mode

150kHz to 80MHz

IEC 61000-4-6

Power Frequency

Magnetic Field

30 A/m

IEC 61000-4-8

<5% U

(>95% dip in U

Voltage Dips and

40% U

(60% dip in U

Interruptions

70% U

(30% dip in U

IEC 61000-4-11

<5% U

(>95% dip in U

is the A.C. mains voltage prior to application test level

Table 3. Guidance and Manufacturer's Declaration of Electromagnetic

The Benesta

Tissue Removal Device is intended for use in the electromagnetic environment

specified below. The customer or the user of the Benesta

it is used in such an environment.

IEC 60601

Compliance

Immunity test

test level

level

Conducted

3 Vrms

Radiated

3 V/m

80 MHz to

IEC

2.5 GHz

61000-4-3

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 Benesta

Tissue Removal Device is used exceeds the applicable RF compliance

level above, the Benesta

Tissue Removal Device should be observed to verify normal operation. If

abnormal performance is observed, additional measures may be necessary, such as re-orienting or

relocating the Benesta

Tissue Removal Device.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Electromagnetic Environment

Test Level / Limits

/ Recommendations

Floors should be wood,

concrete, or ceramic tile. If floors

are covered with synthetic

material, the relative humidity

should be at least 30%

Not Applicable – device is

battery-operated

Not Applicable – device is

battery-operated

Not Applicable – device is

battery-operated

Power frequency magnetic fields

should be at levels typical

commercial or hospital

environments.

) for 0.5 cycle

) for 5 cycles

Not Applicable – device is

) for 25 cycles

battery-operated

) for 5 sec

Immunity

Tissue Removal Device should assure that

Electromagnetic environment – guidance

Portable and mobile RF communications equipment

should be used no closer to any part of the Benesta

Tissue Removal Device, including cables, than the

recommended separation distance calculated from the

equation applicable to the frequency of the transmitter.

Recommended separation distance (in meters)

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: