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Guidance and manufacturer’s declarations, For professional use only, Guidance and manufacturer’ s declarations – Welch Allyn Digital MacroView Otoscope - User Manual User Manual

Page 473

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Mat’l No. 708802 Rev

. B

For Professional Use Only

4341 State Stre

et

Road

Skan

eateles Falls, N

Y

131

53

USA

Phone

: (80

0) 535

-6663 (U

S Only

) or

(315) 685-45

60

• Fax: (3

15)

685

-3361

Guidance and Manufacturer’

s Declarations

Cau

tion

ME

DICAL EL

ECTRICAL EQUIP

M

E

N

T need

s special

precautio

n

s r

egarding EMC and needs to b

e

inst

all

ed and put into ser

v

ice according t

o the

f

o

llo

wing EMC inf

o

rmation pro

v

ide

d

.

Cau

tion

P

o

rt

able

and mobile R

F

com

m

unications

equipm

ent

can

af

fe

ct MEDICAL E

L

ECTRICAL EQUIP

M

ENT

.

Emissions

for all

EQUIPM

ENT and SYSTEMS

Th

e D

igita

l M

acro

V

ie

w

is in

te

nd

ed

f

or

u

se in th

e ele

ct

ro

m

ag

ne

tic e

nviro

nme

nt

spe

cif

ie

d b

elow

. T

he

cu

st

ome

r or

user

o

f th

e D

igita

l M

acro

V

ie

w

sh

ou

ld

assure

th

at it

is use

d in such an

en

viro

nm

en

t.

Immunity for all EQUIPME

N

T

a

nd

SYSTEMS

Th

e Dig

it

al Ma

cr

oV

iew is in

te

nd

ed

f

or use

in

th

e el

ec

tr

oma

gn

et

ic en

vir

onme

nt

s

pe

cif

ied

be

low

. T

he

cus

to

m

er

o

r

us

er

o

f

th

e

D

igi

tal

MacroV

ie

w should

assur

e

th

at

it

is

used

in

su

ch

an

e

nviro

nme

nt

.

Emissions

Te

st

Compliance

Electromagn

etic Environ

me

nt

- Guidance

Immunity T

e

st

IEC 60601

Te

st L

e

vel

Comp

lianc

e Level

E

lec

tromagnetic

Environment -

Guidan

ce

RF emissions

CI

S

PR 11

Group 1

The Digita

l Ma

cr

oV

ie

w

uses RF energ

y only

fo

r

its

interna

l

function.

Th

erefore, its RF em

issions a

re very

lo

w

and

are

not likely

to cause any

interfe

rence in nearb

y electronic

equipment.

Electrostatic

disc

ha

rge (ESD)

IEC 6100

0-4-2

± 6 k

V

c

ontact

± 8 k

V

air

± 6 k

V

c

ontact

± 8 k

V

air

Floors

sho

uld be wood, c

oncrete,

or ceramic

tile

. If floors

are

covered

with synthe

tic

material,

the r

elat

ive

humidity

shou

ld be at least 30%.

RF emissions

CI

S

PR 11

Class B

The

Digita

l Ma

cr

oV

ie

w is suitable f

or use

in a

ll

establishmen

ts includ

ing

dome

stic a

nd

those

directly

connected

to the pub

lic

low-voltage power supply

ne

twork

that supplie

s build

ing

s used for domestic

purp

oses.

Electrical fast

transient (E

FT

)/burst

IEC 6100

0-4-4

±2 kV mains

±1 kV I/O

±2 kV mains

N

ot ap

plicable

Mains power

quality

sh

ould be

that o

f a

ty

pi

cal commercial

or hospital

en

vi

ronmen

t.

Harmonic

emissions

IE

C 61000

-3-2

Class A

S

urge

IEC 6100

0-4-5

±1 kV differential

±2 kV

common

±1 kV different

ial

±2 kV

common

Mains power

quality

sh

ould be

that o

f a

ty

pi

cal commercial

or hospital

en

vi

ronmen

t.

Vo

ltag

e

flu

ctu

atio

ns/

flicker

emissions

IE

C 61000

-3-3

Co

mp

lies

Vo

lta

ge dip

s, s

hort

interruptions, a

nd

voltage variation

s

on

power supply

input

lines.

IEC 6100

0-4-11

>95

%

dip

in 0.

5

cycl

e

60%

di

p in 5

cycl

es

30% dip

for 25

cyc

les

>95

% dip

in 5

secon

ds

>95

%

dip

in 0.

5

cycl

e

60% di

p

in 5

cycl

es

30% di

p

for 25

cycl

es

>95

% dip

in 5

secon

ds

Mains power

quality

sh

ould be

that o

f a

ty

pi

cal commercial

or hospital

en

vi

ronmen

t. If

the user of the Dig

ital

MacroV

iew requires

cont

inue

d

operation during power

mains interru

ptio

ns,

it

is

recommend

ed th

at t

he D

igital

MacroV

iew be

po

wered from an

un

in

terruptible

po

wer

supp

ly or

ba

ttery

.

Power frequ

ency

(50/60

Hz)

magne

tic field

IEC 6100

0-4-8

3 A/m

3 A/m

Powe

r

freq

uency

mag

netic

field

s should be at

levels

chara

cte

ristic

of a typical location in

a typic

al commercial

or hospital

en

vi

ronmen

t.