EZ-IO G3 Power Driver Directions for Use Rev E

Vidacare.com

Vidacare.com

Vidacare Declaration Electromagnetic Emissions The G3 Power Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the Vidacare Driver should assure that it is issued in such an environment. Emission Test

Compliance

Compliance

RF Emissions CISPR 11

Group 1

The G3 Power Driver uses RF energy only for its internal function. Therefore, its RF Emissions are very low and are not likely to cause interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

The G3 Power Driver is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissions IEC 61000-3-3

Not applicable

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The G3 Power Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the G3 Power Driver should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance Level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Power Driver including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

The G3 Power Driver is intended for use in the electromagnetic environment specified below. The customer or the user of the Vidacare Driver should assure that it is used in such an environment.

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Not applicable (battery powered)

d = 3,5 V1

P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

d = 3,5 E1

P P

Immunity test

IEC 60601 test level

Compliance Level

Electromagnetic environment - guidance

d=

Electrostatic discharge (ESD) IEC 61000-4-2

+/- 6 kV Contact

+/- 6 kV Contact

+/- 8 kV air

+/- 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material the relative humidity should be at least 30%

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).

Electrical fast Transient/burst IEC 61000-4-4

+/- 2 kV for power supply lines

Not applicable (battery powered)

Mains power quality should be that of a typical commercial or hospital environment

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

+/- 1 kV for input. output lines

Not applicable (no I/O lines)

Surge

+/- 1 kV differential mode

Not applicable (battery powered)

IEC 61000-4-5

+/- 2 kV common mode

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

< 5% Ur (>95% dip in Ur) for 0.5 cycles

Not applicable (battery powered)

Mains power quality should be that of a typical commercial or hospital environment. If the user of the G3 Power Driver requires continued operation during power mains interruptions, it is recommended that the Power Driver be powered from an uninterruptible power supply or a battery.

40% Ur (60% dip in Ur) for 5 cycles

IEC 61000-4-11 70% Ur (30% dip in Ur) for 25 cycles <5% Ur (95% dip in Ur) for 5 sec 3 A/m

The G3 Power Driver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the G3 Power Driver can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EZ-IO Power Driver recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Recommended separation distance

Vidcare’s Declarations – Electromagnetic Immunity

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

Recommended separation distances between portable and mobile RF communications equipment and the [EQUIPMENT or SYSTEM]

3 A/m

Power frequency magnetic fields should be at levels characteristic of typical location in typical

7 E1

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. a 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 filed strength in the location in which the G3 Power Driver is used exceeds the applicable RF compliance level above, the G3 Power Driver should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the G3 Power Driver. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

d = 3,5 V1

d = 3,5 E1

d=

P

P

7 E1

P

.01

0.12

0.12

0.23

.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. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The use of Accessories, transducers and cables other than those specified by the manufacturer, may result in increased Emissions or decreased Immunity of the Power Driver. The G3 Power Driver should be observed to verify normal operation in the configuration in which it will be used. The G3 Power Driver is designed and tested to run intermittently with a duty cycle of 30 seconds on 1 minute off cycle.

Equipment Classification Type of protection against electric shock

NA internal powered equipment

Degree of protection against electric shock

Type BF applied part

Degree of protection against ingress of water

LPX0 or ordinary protection

Degree of safety or application in the presence of a flammable anesthetic mixture

Equipment not suitable for use in the presence of a flammable anesthetic Mixture with air or with oxygen or nitrous oxide

Mode of operation

Continuous

NOTE Ur is the a.c. mains voltage prior to application of the test level. At the completion of the G3 Power Driver’s service life, proper disposal is the responsibility of the institution or service (directive 2002/96/EC). Degree of protection against electric shock BF Applied part.