background image

12

Guidance

Guidance

Guidance

Guidance and

and

and

and manufacturer

manufacturer

manufacturer

manufacturer’’’’ssss declaration

declaration

declaration

declaration –

– electromagnetic

electromagnetic

electromagnetic

electromagnetic immunity

immunity

immunity

immunity –

for

for

for

for EQUIPMENT

EQUIPMENT

EQUIPMENT

EQUIPMENT and

and

and

and SYSTEMS

SYSTEMS

SYSTEMS

SYSTEMS that

that

that

that are

are

are

are not

not

not

not LIFE-SUPPORTING

LIFE-SUPPORTING

LIFE-SUPPORTING

LIFE-SUPPORTING

Guidance

Guidance

Guidance

Guidance and

and

and

and manufacture

manufacture

manufacture

manufacturerrrr’’’’ssss declaration

declaration

declaration

declaration –

– electromagnetic

electromagnetic

electromagnetic

electromagnetic immunity

immunity

immunity

immunity

The

CMS50QB

Pulse Oximeter

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

CMS50QB

Pulse Oximeter

should assure that it is used in such an environment.

Immunity

Immunity

Immunity

Immunity test

test

test

test

IEC

IEC

IEC

IEC 60601

60601

60601

60601 test

test

test

test level

level

level

level

Compliance

Compliance

Compliance

Compliance

level

level

level

level

Electromagnetic

Electromagnetic

Electromagnetic

Electromagnetic environment

environment

environment

environment ---- guidance

guidance

guidance

guidance

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF communications equipment should
be used no closer to any part of the

CMS50QB

Pulse

Oximeter

, including cables, than the recommended

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

Recommended

Recommended

Recommended

Recommended separation

separation

separation

separation distance

distance

distance

distance

P

V

d

=

1

5

.

3

P

E

d

=

1

5

.

3

80 MHz to 800 MHz

P

E

d

=

1

7

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 metres (m).
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

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 field
strength in the location in which the

CMS50QB

Pulse Oximeter

is used exceeds the applicable RF compliance level above, the

CMS50QB

Pulse Oximeter

should be observed to verify normal operation. If abnormal performance is observed, additional

measures may be necessary, such as reorienting or relocating the

CMS50QB

Pulse Oximeter

.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than

3 V/m.

All manuals and user guides at all-guides.com

Summary of Contents for MDD42EEC

Page 1: ...ot not not be be be be used used used used on on on on the the the the same same same same finger finger finger finger for for for for more more more more than than than than 2 2 2 2 hours hours hours...

Page 2: ...2 Battery installation 5 5 3 Accessories 5 6 6 6 6 Operating Operating Operating Operating Guide Guide Guide Guide 5 5 5 5 6 1 Application method 5 6 2 Attention for operation 6 6 3 Clinical restrict...

Page 3: ...III Appendix Appendix Appendix Appendix A A A A 10 10 10 10 All manuals and user guides at all guides com...

Page 4: ...check the packing before use to make sure the device and accessories are totally in accordance with the packing list or else the device may have the possibility of working abnormally Please choose the...

Page 5: ...suspended Please check the chapter 6 1 as reference The device may be not fit for all patients If you are unable to receive approving measure discontinue use A flexible circuit connects the two parts...

Page 6: ...2 3 2 3 Environment Environment Environment Environment requirements requirements requirements requirements Storage Environment a Temperature 40 60 b Relative humidity 5 95 c Atmospheric pressure 500...

Page 7: ...mance erformance erformance in in in in w w w weak eak eak eak f f f filling illing illing illing c c c condition ondition ondition ondition SpO2 and pulse rate can be detected correctly when pulse fi...

Page 8: ...5 5 5 5 3 3 3 3 Accessories Accessories Accessories Accessories A A A A One rechargeable buttony battery Type LiR2450 B B B B Charge accessories One power adapter Type CMS0105 one charger Type LiCh 10...

Page 9: ...In the normal measure or alarm pause state short press the button can switch the display mode of the screen 6 1 5 6 1 5 6 1 5 6 1 5 Charge Charge Charge Charge Put the rechargeable buttony battery pro...

Page 10: ...f anemic anoxia and toxic anoxia for some patients with serious anemia may also report good SpO2 measurement 7 7 7 7 Maintain Maintain Maintain Maintain transportation transportation transportation tr...

Page 11: ...se charge battery The battery installation is incorrect Install the battery over again The malfunction of the device Please contact the local service center The The The The display display display dis...

Page 12: ...t digital OLED display Pulse Intensity bar graph bar graph OLED display Waveform Waveform OLED display SpO SpO SpO SpO2 2 2 2 Parameter Parameter Parameter Parameter Specification Specification Specif...

Page 13: ...tery Battery Battery working working working working life life life life Charge and discharge not less than 300 times Dimension Dimension Dimension Dimensions s s s and and and and Weight Weight Weigh...

Page 14: ...r or the user of CMS50QB Pulse Oximeter should assure that it is used in such an environment Immunity Immunity Immunity Immunity test test test test IEC IEC IEC IEC 60601 60601 60601 60601 test test t...

Page 15: ...ed from the equation applicable to the frequency of the transmitter Recommended Recommended Recommended Recommended separation separation separation separation distance distance distance distance P V...

Page 16: ...minimum distance between portable and mobile RF communications equipment transmitters and the CMS50QB Pulse Oximeter as recommended below according to the maximum output power of the communications e...

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