Contec Mdd93eec Instruction Manual

I

Instructions

Instructions to

to

to User

User

Dear users, thank you very much for purchasing the Pulse Oximeter.

This Manual is written and compiled in accordance with the council directive MDD 93/42/EEC for

medical devices and harmonized standards. In case of modifications and software upgrades, the

information contained in this document is subject to change without notice.

The Manual describes, in accordance with the Pulse Oximeter

’

s features and requirements, main

structure, functions, specifications, correct methods for transportation, installation, usage, operation,

repair, maintenance and storage, etc. A s well as the safety procedures to protect both the user and

equipment. Refer to the respective chapters for details.

Please read the User Manual carefully before using this product.The User Manual which describes

the operating procedures should be followed strictly. Failure to follow the User Manual may cause

measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible

for the safety, reliability and performance issues and any monitoring abnormality, human injury and

equipment damage due to users' negligence of the operation instructions. The manufacturer

’

s

warranty service does not cover such faults.

Owing to the forthcoming renovation, the specific products you received may not be totally in

accordance with the description of this User Manual. We would sincerely regret for that.

This product is medical device, which can be used repeatedly.

WARNING:

�

�Discomfort

Discomfort

Discomfort or

or

or pain

pain

pain may

may

may appear

appear

appear if

if

if using

using

using the

the

the device

device

device ceaselessly,

ceaselessly,

ceaselessly, especially

especially

especially for

for

for the

the

microcirculation

microcirculation barrier

barrier

barrier patients.

patients.

patients. It

It

It is

is

is recommended

recommended

recommended tha

tha

tha t

t

t the

the

the pulse

pulse

pulse oximeter

oximeter

oximeter should

should

should not

not

not be

be

used

used on

on

on the

the

the same

same

same finger

finger

finger for

for

for more

more

more than

than

than 2

2

2 hours.

hours.

�

�For

For

For the

the

the special

special

special patients,

patients,

patients, there

there

there should

should

should be

be

be a

a

a more

more

more prudent

prudent

prudent inspecting

inspecting

inspecting in

in

in the

the

the placing

placing

placing process.

process.

The

The device

device

device can

can

can not

not

not be

be

be clipped

clipped

clipped on

on

on the

the

the edema

edema

edema and

and

and tender

tender

tender tissue.

tissue.

�

�The

The

The light

light

light (the

(the

(the infrared

infrared

infrared is

is

is invisible)

invisible)

invisible) emitted

emitted

emitted from

from

from the

the

the device

device

device is

is

is harmful

harmful

harmful to

to

to the

the

the eyes,

eyes,

eyes, so

so

so the

the

user

user and

and

and the

the

the maintenance

maintenance

maintenance man

man

man should

should

should not

not

not look

look

look at

at

at the

the

the light

light

light source

source

source .

.

�

�Testee

Testee

Testee can

can

can not

not

not use

use

use enamel

enamel

enamel or

or

or other

other

other makeup.

makeup.

�

�Testee

Testee

’

s

s fingernail

fingernail

fingernail can

can

can not

not

not be

be

be too

too

too long.

long.

�

�Please

Please

Please refer

refer

refer to

to

to the

the

the correlative

correlative

correlative literature

literature

literature about

about

about the

the

the clinical

clinical

clinical restrictions

restrictions

restrictions and

and

and caution.

caution.



This

This device

device

device is

is

is not

not

not intended

intended

intended for

for

for treatment.

treatment.

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II

Contents

1

1 Safety

Safety

Safety ..............................................................................................................................................

..............................................................................................................................................

.............................................................................................................................................. 1

1

1.1 Instructions for safe operations ............................................................................................. 1

1.2 Warning .................................................................................................................................... 1

1.3 Attention ................................................................................................................................... 1

2

2 Overview

Overview

Overview ........................................................................................................................................

........................................................................................................................................

........................................................................................................................................ 2

2

2.1 Features .................................................................................................................................... 2

2.2 Major applications and scope of application ....................................................................... 3

2.3 Environment requirements ...................................................................................................... 3

3

3 Principle

Principle

Principle .........................................................................................................................................

.........................................................................................................................................

......................................................................................................................................... 3

3

4

4 Technical

Technical

Technical specifications

specifications

specifications ................................................................................................................

................................................................................................................

................................................................................................................ 3

3

4.1 Main performance ................................................................................................................... 3

4.2 Main parameters ...................................................................................................................... 4

5

5 Installation

Installation

Installation .....................................................................................................................................

.....................................................................................................................................

..................................................................................................................................... 4

4

5.1 View of the front panel ......................................................................................................... 4

5.2 Battery installation .................................................................................................................. 5

5.3 Accessories ............................................................................................................................... 5

6

6 Operating

Operating

Operating Guide

Guide

Guide ...........................................................................................................................

...........................................................................................................................

........................................................................................................................... 5

5

6.1 Application method ................................................................................................................. 5

6.2 Attention for operation ........................................................................................................... 6

6.3 Clinical restrictions ................................................................................................................. 7

7

7 Maintain

Maintain

Maintain 、transportation

transportation

transportation and

and

and storage

storage

storage .....................................................................................

.....................................................................................

..................................................................................... 7

7

7.1 Cleaning and disinfecting ....................................................................................................... 7

7.2 Maintain ................................................................................................................................... 7

7.3 Transportation and storage ..................................................................................................... 7

8

8 Troubleshooting

Troubleshooting

Troubleshooting .............................................................................................................................

.............................................................................................................................

............................................................................................................................. 8

8

9

9 Key

Key

Key of

of

of symbols

symbols

symbols .............................................................................................................................

.............................................................................................................................

............................................................................................................................. 8

8

10

10 Function

Function

Function specification

specification

specification ................................................................................................................

................................................................................................................

................................................................................................................ 9

9

Appendix

Appendix A

A

A ........................................................................................................................................

........................................................................................................................................

........................................................................................................................................ 11

11

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III

Appendix

Appendix A

A

A .................................................................................................................................................................

.................................................................................................................................................................

................................................................................................................................................................. 10

10

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1

1 Safety

Safety

1.1

1.1 Instructions

Instructions

Instructions for

for

for safe

safe

safe operations

operations

Check the main unit and all accessories periodically to make sure that there is no visible

damage that may affect patient

’

s safety and monitoring performance.It is recommended that the

device should be inspected weekly at least. When there is obvious damage, stop using the device.

Necessary maintenance must be performed by qualified service engineers

ONLY.

Users are not

permitted to maintain it by themselves.

The oximeter cannot be used together with devices not specified in User

’

s Manual. Only the

accessory that is appointed or recommendatory by manufacture can be used with this device.

This product is calibrated before leaving factory.

1.2

1.2 Warning

Warning



Explosive hazard — DO NOT use the oximeter in the environment with tinder such as

anesthetic .



DO NOT use the oximeter while the patient is being scanned by MRI or CT.



The person who is allergic to rubber can not use this device.



The disposal of scrap instrument and its accessories and packing (including battery, plastic

bags, foams and paper boxes) should follow the local laws and regulations.

Please 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 accessories which are appointed or recommended by the manufacturer for

avoiding device damag e .

Please don't measure this device with functional tester for the device's related information.

Prevent children from swallowing the product or its accessories.For children users,please use

the product under the condition of adult guardianship.



When installing or removing the battery,do not wear electric articles on hands to prevent from

short circuit and burning the skin.



It is not recommended to use the device in high frequency environment.



In the area where the blast is easy to happen because of potential factor,don't take out,install or

charge the battery in order to avoid blast or fire .



Please charge the battery in the room temperature environment.



In addition,the overall check of monitor,including the safety check such as the leakage

current ,should be performed only by qualified personnel once every 12 months.

1.3

1.3 Attention

Attention



Keep the oximeter away from dust, vibration, corrosive substances, tinder, high temperature

and moisture.



If the oximeter gets wet, pleas e stop operati on .

When it is carried from cold environment to warm or humid environment, please do not use it

immediately.

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2



DO NOT operate button on front panel with sharp thing s.



High temperature or high pressure steam disinfection for the oximeter is not permitted. Refer to

User Manual in the relative chapter (7.1) for cleaning and disinfection.



Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface

with medical alcohol by soft material. Do not spray any liquid on the device directly.



When cleaning the device with water, the temperature should be lower than 60 ℃.



T he fingers which are too thin or too cold may affect the measure accuracy , please clip the

thick er finger such as thumb and middle finger deeply enough into the probe.



The update period of data is less than 5 seconds, which is changeable according to different

individual pulse rate.



Please read the measure value when the waveform on screen is equably and steady-going . T his

measure value is optimal value ,a nd the waveform at the moment is the standard one.



If some abnormal conditions appear on the screen during test process, pull the finger out and

reinsert to restore normal use.



The device has normal life for three years since the first electrified use.



The device has pulse sound indication function.Please check the chapter 6.1 as reference.



The device has the function of beyond limit alarm .W hen the measure data is beyond the highest

or lowest limit, the device would start alarm automatically .



The device has the alarm function, this function can be 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 part s of the device . Do not twist or pull on the connection.

2

2 Overview

Overview

The pulse oxygen saturation is the percentage of Hb O

2

in the total Hb in the blood, so-called the O

2

concentration in the blood. It is an important bio-parameter for the respiration. A number of diseases

relating to respiratory system may cause the decrease of SpO

2

in the blood, furthermore, some other

causes such as the malfunction of human body's self-adjustment, damages during surgery, and the

injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in

human body, and the corresponding symptoms would appear as a consequence, such as vertigo,

impotence, vomit etc. Serious symptoms might bring danger to human's life.Therefore, prompt

information of patients' SpO

2

is of great help for the doctor to discover the potential danger, and is of

great importance in the clinical medical field.

The Pulse Oximeter is small in volume ,l ow in power consumption , convenient in operation and

portable.It is only necessary for patient to put one finger into probe for diagnosis, and the display

screen will directly show the SpO

2

value with the high veracity and repetition.

2.1

2.1 Features

Features

A

ANovel appearance , more fit for children.

B

BS mall in volume, light in weight and convenient in carrying.

C

CL ow power consumption

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3

2.2

2.2 Major

Major

Major applications

applications

applications and

and

and scope

scope

scope of

of

of application

application

The Pulse Oximeter can be used in measur ing t he pulse oxygen s aturation and pulse rat e through

finger.The product is fit for family, hospital, o xygen b ar, community healthcare, physical care in

sports (It can be used before or after doing sports and it is not recommended to use the device during

the process of having sport ) and etc.

The

The problem

problem

problem of

of

of overrating

overrating

overrating would

would

would emerge

emerge

emerge when

when

when the

the

the patient

patient

patient is

is

is suffering

suffering

suffering from

from

from toxicosis

toxicosis

which

which is

is

is caused

caused

caused by

by

by carbon

carbon

carbon monoxide,

monoxide,

monoxide, the

the

the device

device

device is

is

is not

not

not recommended

recommended

recommended to

to

to be

be

be used

used

used under

under

under this

this

circumstance.

2.3

2.3 Environment

Environment

Environment requirements

requirements

Storage Environment

a) Temperature :-40 ℃ ～ +60 ℃

b) Relative h umidity :5% ～95%

c) Atmospheric pressure :500hPa ～1060hPa

Operating Environment

a) Temperature : 10 ℃ ～ 40 ℃

b) Relative Humidity :30% ～75%

c) Atmospheric pressure:700hPa ～1060hPa

3

3 Principle

Principle

Principle of the Oximeter is as follows: An experience formula of data process is established taking

use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive

Hemoglobin (Hb) and Oxyhemoglobin ( Hb O

2

) in glow & near-infrared zones. Operation principle of

the device is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with

Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of

lights can be focused onto human nail tip through perspective clamp finger-type sensor.Then

measured signal can be obtained by a photosensitive element, information acquired through which

will be shown on screen through treatment in electronic circuits and microprocessor.

Figure 1

W

ork elements

4

4 Technical

Technical

Technical specifications

specifications

4.1

4.1 Main

Main

Main performance

performance

SpO

2

value display , Pulse rate value display

B ar graph display

Pulse waveform display

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4



Pulse sound indication



Low- power indication: when the battery is low in power,the symbol will blink.



With alarm function



With screen overturn function

4.2

4.2 Main

Main

Main p

p

p arameters

arameters

A

A Measurement

Measurement

Measurement of

of

of SpO

SpO

2

Measuring range: 0 % ～100 ％

Accuracy: 70~100% : ± 2%;Below 70% : unspecified .

B

B Measurement

Measurement

Measurement of

of

of pulse

pulse

pulse rate

rate

Measuring range: 30 bpm ～2 5 0bpm

Accuracy: ± 2 bpm or ± 2% (select larger)

C

C Resolution

Resolution

SpO

2

: 1%, Pulse rate: 1bpm

D

D Measurement

Measurement

Measurement p

p

p erformance

erformance

erformance in

in

in w

w

w eak

eak

eak f

f

f illing

illing

illing c

c

c ondition:

ondition:

SpO

2

and pulse rate can be detected correctly when pulse-filling ratio is 0.4%.SpO

2

error is ± 4%;

pulse rate error is ± 2 bpm or ± 2% (select larger).

E

E Resistance

Resistance

Resistance to

to

to surrounding

surrounding

surrounding light:

light:

The deviation between the value measured in the condition of man-made light or indoor natural light

and that of darkroom is less than ± 1%.

F

F Power

Power

Power supply

supply

supply requirement:

requirement:

requirement: 3.6 V DC ~4.2V DC.

5

5 Installation

Installation

5.1

5.1 View

View

View of

of

of the

the

the front

front

front panel

panel

Figure 2. F ront

V

iew

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5

5.

5. 2

2

2 Battery

Battery

Battery installation

installation

Figure 3. B attery ins tallation

A. Refer to the polarity and put the edge of the battery on the mouth of the battery box ,along the

bottom of the battery box, gently push the battery into the box until the whole battery has been

in-place.( Refer to Figure 3 )

B

B.Replace the cover.

Please

Please take

take

take car

car

car e

e

e of

of

of the

the

the polarity

polarity

polarity when

when

when you

you

you insert

insert

insert the

the

the battery

battery

battery for

for

for the

the

the improper

improper

improper insertion

insertion

may

may damage

damage

damage the

the

the device.

device.

5.

5. 3

3

3 Accessories

Accessories

A.

A. One rechargeable buttony battery (Type: LiR2450)

B.

B. Charge accessories: One power adapter （Type: CMS0105 ）, one charger （Type: LiCh-10 ）, one

data line （Type: USB-AM To USB-miniBM ）

C.

C. One user manual

D.

D. One lanyard

6

6 Operating

Operating

Operating Guide

Guide

6.1

6.1 Application

Application

Application method

method

6.1.1

6.1.1 Basic

Basic

Basic operation

operation

a. Open the battery cover,and put the buttony battery in the battery box,then replace the cover.

b. Insert one finger into the probe of the device.

c. Long p ress the button to turn the device on , and the measure interface appears after the device

self-test .

d. Do not shake the finger and try to keep the patient still during the process.

e. The data can be read directly from the display screen i n the measuring interface.

Figure 4 Finger placement

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6

Fingernails and the luminescent tube should be in the same side.

6.1.2

6.1.2 Pulse

Pulse

Pulse sound

sound

sound setting

setting

After turning the device on,the pulse sound is open.Long press the button can close the pulse sound

and the pulse sound indication icon disappears.Long press button again, the pulse sound is turned on

and pulse sound indication icon appears.

6.1.3

6.1.3 Alarm

Alarm

Alarm setting

setting

a. Alarm includes the alarm of measure data's going beyond the limits (When the SpO

2

is below

90%, or the pulse rate is not between 50bpm and 120bpm,the alarm occurs), the alarm of low-power.

b. In the open state of alarm,when the measure data is beyond the the normal measure range, the

device would give alarm sound and the corresponding value glitter.Alarm could be suspended by

short pressing button,and the alarm icon disappears,but the value still glitter.Alarm function will be

renewed in 30 seconds.

If low-power alarm occurs,please charge the battery;and if the battery has been out of normal

life ,please replace it by a new one.

6.1.4

6.1.4 Display

Display

Display mode

mode

mode switch

switch

I n 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 Charge

Charge

Put the rechargeable buttony battery properly according to the polarity direction in the c harger .

Connect one end of the adapter to the power supply socket,and connect another end of the adapter to

charger by data line.

The power adapt e r of the device accords with the requirements of IEC 60601-1 .

The charger accords with the requirements of IEC 60601-1 .

In charg ing state , the red indication light of the charger will shine,the green indication light of

the charger shining means the charge has been accomplished.

6.2

6.2 Attention

Attention

Attention for

for

for operation

operation

A.

A. Please check the device before using, and confirm that it can work normally.

B

B.The finger should be in a proper position (see the attached illustration of figure 4 for reference), or

else it may result in inaccurate measure.

C.

C. The ray between luminescent tube and photoelectric receiving tube must get across subject

’

s

arteriole .

D.

D. The oximeter should not be used at a location or limb tied with arterial canal or blood pressure

cuff or receiving intravenous injection.

E.

E. Ensure nothing, such as a plaster, can impede the light passage. , or else it may result in inaccurate

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7

measure of SpO

2

and pulse rate .

F.

Excessive ambient light may affect measurement accuracy. It includes fluorescent lamp, dual ruby

light, infrared heater, direct sunlight and etc.

G.

G. Intense acti vity of the subject or extreme electrosurgical interference may also affect the accuracy.

H.

H. Testee can not use enamel or other makeup.

I.

I. Please clean and disinfect the device after operating according to the User Manual (7.1).

6.3

6.3 Clinical

Clinical

Clinical restrictions

restrictions

A.

A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of

subject is required. For a subject with weak pulse due to shock, low ambient/body temperature,

major bleeding, or use of vascular contracting drug, the SpO

2

waveform (PLETH) will decrease. In

this case, the measurement will be more sensitive to interference.

B.

B. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo

green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or

thiosalicylic hemoglobin, and some with icterus problem, the SpO

2

determination by this device may

be inaccurate.

C.

C. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major

factor resulted in serious error of SpO

2

measure.

D.

D. T he SpO

2

value serves as a reference value for judgment of anemic anoxia and toxic anoxia, for

some patients with serious anemia may also report good SpO

2

measurement.

7

7 Maintain

Maintain

Maintain 、transportation

transportation

transportation and

and

and storage

storage

7.1

7.1 Cleaning

Cleaning

Cleaning and

and

and d

d

d isinfecting

isinfecting

Using medical alcohol to wipe the device for disinfect ing , nature dry or clean it with clean soft cloth.

7.2

7.2 Maintain

Maintain

A

APlease clean and disinfect the device before using according to the User Manual (7.1).

B

BPlease recharge the battery when the screen shows low-power (the battery power is ) .

C

CRecharge the battery soon after the over-discharge. The device should be recharged every six

months when it is not regular used. It can extend the battery life following this guidance.

D

DThe device needs to be calibrated once a year (or according to the calibrating program of

hospital). It also can be performed at the state-appointed agent or just contact us for calibration.

7.3

7.3 Transportation

Transportation

Transportation and

and

and storage

storage

A.

A. The packed device can be transported by ordinary conveyance or according to transport contract.

The device can not be transported mixed with toxic, harmful, corrosive material s .

B.

B. The packed device should be stored in room with no corrosive gases and good ventilation.

Temperature: -40 ° C~60 ° C; Relative Humidity : ≤ 95% .

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8

8 Troubleshooting

Troubleshooting

Trouble

Trouble Possible

Possible

Possible Reason

Reason

Reason Solution

Solution

The

The SpO

SpO

2

and

and Pulse

Pulse

Rate

Rate can

can

can not

not

not be

be

displayed

displayed normally

normally

normally .

.

The finger is not properly positioned. Place the finger properly and try

again.

The patient

’

s SpO

2

is too low to be

detected.

Try again ,g o to a hospital for a

diagnosis if you are sure the

device works all right.

The

The SpO

SpO

2

and

and Pulse

Pulse

Rate

Rate are

are

are not

not

display

display ed

ed

ed stabl

stabl

y.

The finger is not placed inside deep

enough.

Place the finger properly and try

again.

The finger is shaking or the patient is

moving.

Let the patient keep still.

The

The device

device

device can

can

can not

not

be

be turn

turn

turn ed

ed

ed on

on

on .

.

The batter y is drained away or almost

drained away .

Please 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 display

display

display is

is

is off

off

suddenly

The batter y is almost drained away. Please charge battery.

The device is set to shut down

automatically in 5 seconds when there is

no signal.

Normal.

The

The device

device

device can

can

can not

not

be

be used

used

used for

for

for full

full

full time

time

after

after charge

charge

The battery is not full charged. Please recharge the battery .

The battery is damaged. Please contact the local service

center.

The

The battery

battery

battery can

can

can not

not

be

be full

full

full charged

charged

charged even

even

after

after 10

10

10 hours

hours

charging

charging time.

time.

The battery is damaged. Please contact the local service

center.

9

9 Key

Key

Key of

of

of s

s

s ymbols

ymbols

Signal Description

Warning – See User Manual

%SpO

2

The pulse oxygen saturation (%)

PRbpm Pulse rate (bpm)

Low-power indication

T he alarm sound indication

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T he pulse sound indication

Type BF

IPX1 Ingress of liquids rank

EUROPEAN REPRESENTA TIVE

WEEE (2002/96/EC)

This item is compliant with Medical Device Directive 93/42/EEC of

June 14, 1993, a directive of the European Economic Community.

battery positive electrode

battery cathode electrode

10

10 Function

Function

Function s

s

s pecification

pecification

Information

Information Display

Display

Display Mode

Mode

The Pulse Oxygen Saturation （SpO

2

）2-digit digital OLED display

Pulse Rate （PR ）3-digit digital OLED display

Pulse Intensity (bar-graph) bar-graph OLED display

Waveform Waveform OLED display

SpO

2

Parameter

Parameter Specification

Specification

Measuring range 0 % ～100%, (the resolution is 1%).

Accuracy 70% ～100% ：± 2% ,Below 70% unspecified.

Pulse

Pulse Parameter

Parameter

Parameter Specification

Specification

Measuring range 30 bpm ～2 5 0bpm, (the resolution is 1bpm)

Accuracy ± 2 bpm or ± 2% (select larger)

Safety

Safety Type

Type

Type Interior Battery ，BF Type

Pulse

Pulse Intensity

Intensity

Range

Continuous bar-graph display, the higher display

indicates the stronger pulse.

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10

Battery

Battery Requirement

Requirement

Voltage 3. 6 rechargeable buttony battery × 1

Battery

Battery working

working

working life

life

Charge and discharge no t less than 3 00 times.

Dimension

Dimension s

s

s and

and

and Weight

Weight

Dimensions 46(L) × 40(W) × 29(H) mm

Weight About 35g (with a rechargeable buttony battery )

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11

Appendix

Appendix A

A

Guidance

Guidance and

and

and manufacture

manufacture

’

s

s declaration

declaration

declaration –

–

– electromagnetic

electromagnetic

electromagnetic immunity

immunity

immunity –

–

for

for all

all

all EQUIPMENT

EQUIPMENT

EQUIPMENT and

and

and SYSTEMS

SYSTEMS

Guidance

Guidance and

and

and manufacture

manufacture

’

s

s declaration

declaration

declaration –

–

– electromagnetic

electromagnetic

electromagnetic 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 test

test

test IEC

IEC

IEC 60601

60601

60601 test

test

test level

level

level Compliance

Compliance

Compliance level

level

Electromagnetic

Electromagnetic environment

environment

environment -

-

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

±

6 kV contact

±

8 kV air

±

6 kV contact

±

8 kV air

Floors should be wood, concrete

or ceramic tile. If floor are

covered with synthetic material,

the relative humidity should be at

least 30%.

Power frequency

(50/60Hz) magnetic

field

IEC61000-4-8

3A/m 3A/m Power frequency magnetic fields

Should be at levels characteristic

of a typical location in a typical

commercial or hospital

environment.

NOTE U

T

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

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12

Guidance

Guidance and

and

and manufacturer

manufacturer

’

s

s declaration

declaration

declaration –

–

– electromagnetic

electromagnetic

electromagnetic immunity

immunity

immunity –

–

for

for EQUIPMENT

EQUIPMENT

EQUIPMENT and

and

and SYSTEMS

SYSTEMS

SYSTEMS that

that

that are

are

are not

not

not LIFE-SUPPORTING

LIFE-SUPPORTING

Guidance

Guidance and

and

and manufacture

manufacture

manufacture r

r

’

s

s declaration

declaration

declaration –

–

– electromagnetic

electromagnetic

electromagnetic 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 test

test

test IEC

IEC

IEC 60601

60601

60601 test

test

test level

level

Compliance

level

Electromagnetic

Electromagnetic environment

environment

environment -

-

- 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 separation

separation

separation distance

distance

PVd

⎥

⎦

⎤⎢

⎣

⎡=

1

5 .3

PEd

⎥

⎦

⎤⎢

⎣

⎡=

1

5 .3

80 MHz to 800 MHz

PEd

⎥

⎦

⎤⎢

⎣

⎡=

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.

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13

Recommended

Recommended separation

separation

separation distances

distances

distances between

between

between portable

portable

portable and

and

and mobile

mobile

RF

RF communications

communications

communications equipment

equipment

equipment and

and

and the

the

the EQUIPMENT

EQUIPMENT

EQUIPMENT or

or

or SYSTEM

SYSTEM

SYSTEM –

–

for

for EQUIPMENT

EQUIPMENT

EQUIPMENT or

or

or SYSTEM

SYSTEM

SYSTEM that

that

that are

are

are not

not

not LIFE-SUPPORTING

LIFE-SUPPORTING

Recommended

Recommended separation

separation

separation distances

distances

distances between

between

portable

portable and

and

and mobile

mobile

mobile RF

RF

RF communications

communications

communications equipment

equipment

equipment and

and

and the

the

CMS50QB

CMS50QB PULSE

PULSE

PULSE OXIMETER

OXIMETER

The

CMS50QB

Pulse Oximeter

is intended for use in an electromagnetic environment in which radiated RF disturbances

are controlled. The customer or the user of the

CMS50QB

Pulse Oximeter

can help prevent electromagnetic interference

by maintaining a 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

equipment.

Rated

Rated maximum

maximum

maximum output

output

power

power of

of

of transmitter

transmitter

(W)

Separation

Separation distance

distance

distance according

according

according to

to

to frequency

frequency

frequency of

of

of transmitter

transmitter

(m)

150

150 kHz

kHz

kHz to

to

to 80

80

80 MHz

MHz

PVd

⎥

⎦

⎤⎢

⎣

⎡=

1

5 .3

80

80 MHz

MHz

MHz to

to

to 800

800

800 MHz

MHz

PEd

⎥

⎦

⎤⎢

⎣

⎡=

1

5 .3

800

800 MHz

MHz

MHz to

to

to 2.5

2.5

2.5 GHz

GHz

PEd

⎥

⎦

⎤⎢

⎣

⎡=

1

7

0.01

0.12 0.12 0.23

0.1

0.37 0.37 0.74

1

1.17 1.17 2.33

10

3.69 3.69 7.38

100

11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.

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Contec MDD93EEC Instruction Manual

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