background image

19

ENGLISH

Appendix II

Guidance and manufacturer’s declaration – electromagnetic emissions for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not 

LIFE-SUPPORTING  

Guidance and manufacturer’s declaration – electromagnetic emission

The 28066 / NE-M01 is intended for use in the electromagnetic environment specified below. The customer or the user of the 

28066 / NE-M01 should make sure that it is used in such an environment.

Emission test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The 28066 / NE-M01 uses 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

The 28066 / NE-M01 is suitable for use in all establishments, in-

cluding domestic establishments and those directly connected to 

the public low-voltage power supply network that supplies buildings 

used for domestic purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity

The 28066 / NE-M01 is intended for use in the electromagnetic environment specified below. The customer or the user of the 

28066 / NE-M01 should make sure 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

Air Discharge: ±2 kV, 

±4 kV, ±8 kV, ±15 kV 

contact: ±8 kV air

Air Discharge: ±2 kV, 

±4kV, ±8 kV, ±15 kV

contact: ±8 kV air

Floors  should  be  wood,  concrete  or  ce-

ramic tile. If floor is covered with synthetic 

material, the relative humidity should be 

at least 30 %.

Power frequency 

(50/60Hz) magnetic 

field IEC61000-4-8

30 A/m

30 A/m

Mains power quality should be that of a 

typical commercial or hospital environ-

ment.

NOTE: 

U

T

 is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity

The 28066 / NE-M01 is intended for use in the electromagnetic environment specified below. The customer or the user of the 

28066 / NE-M01 should make sure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance 

level

Electromagnetic environment 

guidance

Radiated RF

IEC 61000-4-3

10 V/m 

80 MHz to 2.7 GHz

10 V/m

Portable  and  mobile  RF  communications  equipment 

should be used no closer to any part of the 28066 / NE-

M01, including cables, than the recommended separa-

tion distance calculated from the equation applicable to 

the frequency of the transmitter.

Recommended separation distance

                    80MHz to 800MHz

 
                    800MHz to 2,7GHz

Where 

P

  is  the  maximum  output  power  rating  of  the 

transmitter in watts (W) according to the transmitter man-

ufacturer and 

d

 is the recommended separation distance 

in metres (m).

Interference may occur in the vi-

cinity  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.

3.5

E

 

1

√P

d=

 7

E

 

1

√P

d=

3.5

V

 

1

√P

d=

Summary of Contents for 28066

Page 1: ...TTENTION The operators must carefully read and completely understand the present manual before using the product AVIS Les op rateurs doivent lire et bien comprendre ce manuel avant d utiliser le produ...

Page 2: ...thetic mixture Otherwise it may cause personal injury Do not wrap the power cord around children s neck or other sensitive areas or it may cause asphyxia The mask of this equipment is made of PVC mate...

Page 3: ...batteries is DC3V 2 3 Operational environment Temperature 5 C 40 C Humidity 15 90 Atmospheric pressure 700hPa 1060hPa Attention This product is not suitable for use in strong electromagnetic interfer...

Page 4: ...cup to the main unit be sure to install it properly until clasp sound is heard Otherwise it may cause electrode conduction failure then the device cannot atomize normally 2 Remove medication cup from...

Page 5: ...ery life will be affected Remove the batteries if the device won t be used for long time 4 2 Operations for treatment use Preparations before use 1 Remove medication cup please clean and disin fect it...

Page 6: ...the cup lid and discard residual medication 3 Add 75 ethanol solution in medication cup cover the cup lid then leave for at least 10mins it is advisable to gently shake it for better disinfection 4 Im...

Page 7: ...medication cup Trickle medication into medication cup re member not to exceed its maximum capacity Improper medication Consult a doctor about whether the medica tion is suitable for the device The ne...

Page 8: ...ode Keep away from sunlight 55 C 40 C Store between 40 and 55 C Lot number Fragile handle with care Date of manufacture Serial number Follow instructions for use Medical Device complies with Directive...

Page 9: ...4 2 Air Discharge 2 kV 4 kV 8 kV 15 kV contact 8 kV air Air Discharge 2 kV 4kV 8 kV 15 kV contact 8 kV air Floors should be wood concrete or ce ramic tile If floor is covered with synthetic material...

Page 10: ...ct was purchased If the equipment is not disposed of correctly fines or penalties may be applied in accordance with the national legislation and regulations GIMA WARRANTY CONDITIONS Congratulations fo...

Reviews: