Contec Cms60c User manual

I

CONTEC MEDICAL SYSTEMS C O

., LTD

CMS

CMS 60C

60C

Pulse

Pulse Oximeter

Oximeter

II

Instructions

Instructions to

to

to User

User

Dear u sers, 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. as 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. T he 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 user s' 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:

�

�Uncomfortable

Uncomfortable

Uncomfortable or

or

or painful

painful

painful feeling

feeling

feeling 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

the

the microcirculation

microcirculation

microcirculation barrier

barrier

barrier patients.

patients.

patients. It

It

It is

is

is recommended

recommended

recommended that

that

that the

the

the sensor

sensor

sensor should

should

should not

not

not be

be

applied

applied to

to

to the

the

the same

same

same finger

finger

finger for

for

for over

over

over 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 stare

stare

stare at

at

at the

the

the light.

light.

�

�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

Testee ’

’

’ s

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

This device

device

device is

is

is not

not

not intended

intended

intended for

for

for treatment.

treatment.

III

C

C ontents

ontents

1Safety

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

1

1.1Instructions for safe operations

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

1.2Warning

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

1.3Attention

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

2.Overview

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

2

2.1Features

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

2.2Major applications and scope of application

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

2.3Environment requirements

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

3.Principle

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

3

4.Technical

4.Technical specifications

sp ecifications

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

3

4.1Main performance

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

4.2Main Parameters

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

5Installation

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

5

5.1View

5.1View of

of

of the

the

the front

front

front panel

panel

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

5

5.2Under side View and Left View

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

5.3Rear View

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

5.4Accessories

........................................................................................................................................................... 6

6Operating

6Operating Guide

Guide

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

6

6.1Application method

............................................................................................................................................ 6

6.2Attention for operation

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

6.3Clinical restrictions

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

7Maintain

7Maintain 、transportation

transportation

transportation and

and

and storage

storage

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

12

7.1Cleaning and Disinfecting

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

12

7.2Maintain

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

12

7.3Transportation and storage

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

12

8Troubleshooting

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

12

9Key

of

Symbols

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

13

10Function

10Function Specification

Specification

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

14

Appendix1

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

16

Appendix2

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

18

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 about cables and transducers. It

is recommended that the device should be inspected once a week 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 appointed or recommendatory by manufacture can be used with this device.

This product is calibrated before leav ing factory.

1.2

1.2 Warning

Warning

Explosive hazard — DO NOT use the oximeter

in

environment with inflammable gas such as

some ignitable anesthetic agents.

DO NOT use the oximeter while the testee measured by MRI and CT.

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



The disposal of scrap instrument and its accessories and packings (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 and probe which are approved or manufactured by the

manufacturer, or else

it

may damage the device.

Please choose the battery chargers which should be ensured compliance with the requirements

of IEC 601-1 , or else

it

may damage the device.

The device can only be matched with the compatible probe.

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

1.

1. 3

3

3 Attention

Attention

Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high

temperature and moisture.

If the oximeter gets wet, please stop operating it.



When

it

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

it

immediately.

DO NOT operate keys on front panel with sharp materials.

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

User Manual

in

the relative chapter ( 7 .1) for instructions of 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 ℃.

As to the fingers which are too thin or too cold,

it

would probably affect the normal measure

of the patients' SpO

2

and pulse rate, please clip the thick finger such as thumb and middle finger

deeply enought into the probe.

2

The pulse oximeter can be used to adult or infant. Whether the device is used to adult or

infant,it depends on the probe selected.

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

individual pulse rate.

Please read the measured value when the waveform on screen is equably and steady-going,

This measured value is optimal value. And the waveform at the monment is the standard one.

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

reinsert to restore normal use.

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

This device has the function of alarming, users can check on this function according to chapter

6.1 as a reference.

The device has the function of limits alarming, when the measured data is beyond the highest

or lowest limit, the device would start alarming automatically on the premise of the alarming

function is on.

The device has the function of alarming, this function can either be paused, or closed for good,

please check the chapter 6.1 as a reference.

The device may not work for

all

patients. If you are unable to achieve stable readings,

discontinue use.

2.

2. O

O

O verview

verview

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 features

in

small volume, low power consumption, convenient operation and

being portable.It is only necessary for patients to put one of his fingers into a probe for diagnosis,

and a display screen will directly show the measured value of pulse oxygen s aturation with the high

veracity and repetition.

2

2 .1

.1

.1 Features

Features

A.

A. Operation of the product is simple and convenient.

B.

B. The product is small

in

volume, light

in

weight and convenient

in

carrying.

C.

L

ow power consumption

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 suitable for being used

in

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.

3

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 caused

caused

by

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

:

500h Pa ～106 0h Pa

Operating Environment

a) Temperature

:

10 ℃～40℃

b ) Relative Humidity

:

30 % ～75 %

c ) Atmospheric pressure: 700h Pa ～106 0h Pa

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.

4.

4. Technical

Technical

Technical specifications

specifications

4.1

4.1 Main

Main

Main performance

performance

A.

A. SpO

2

value display

B.

B. P ulse rate value display , bar graph display

C.

C. Pulse waveform display

D.

L

ow-voltage indicat ion: low-voltage indicator appears before working abnormally which is due

to low-voltage

E.

E. The display mode can be changed

F.

Screen brightness can be changed

G.

A

pulse sound indicat ion

4

H

.

.With alarm function

I

I .

.

.With SpO

2

value and pulse rate value of storage, the stored data can be uploaded to computers

J

J .

.

.It can be connected with an external oximeter probe

K

.

.Real-time data can be transmitted to computers.

4.2

4.2 Main

Main

Main Parameters

Parameters

A.

A. Measurement

Measurement

Measurement of

of

of SpO

SpO

2

Measur ing range: 0 % ～100 ％

Accuracy:

When the SpO

2

measuring range is 7 0% ～100 ％,t he permission of absolute error is ± 2 ％；

below 70% unspecified

B.

B. Measurement

Measurement

Measurement of

of

of pulse

pulse

pulse rate

rate

Measur ing range: 30 bpm ～2 5 0bpm

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

C.

C. Resolution

Resolution

SpO

2

:

1%, Pulse rate

:

1 bpm .

D.

D. Measurement

Measurement

Measurement Performance

Performance

Performance in

in

in Weak

Weak

Weak Filling

Filling

Filling Condition:

Condition:

SpO

2

and pulse rate can be shown 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.

Power

Power supply

supply

supply requirement:

requirement:

requirement: :

:

: 3.6

3.6

3.6 V

V

V DC

DC

DC ~

~

~ 4.2V

4.2V

4.2V DC.

DC.

G.

G. Optical

Optical

Optical Sensor

Sensor

Red light (wavelength is 660nm ，6.65mW)

Infrared (wavelength is 880 nm, 6.75mW)

H.

H. Adjustable

Adjustable

Adjustable alarm

alarm

alarm range:

range:

SpO

2

：0 % ~100 %

Pulse Rate: 0 bpm ~254 bpm

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

5.2

5.2 Underside

Underside

Underside View

View

View and

and

and Left

Left

Left View

View

Finger 3. Underside View and Left View

1. Probe jack

:

It is used to connect a SpO

2

sensor to measure the oxygen saturation and pulse rate .

2. USB port

:

It is used to connect a personal computer to export the trend data (or real-time data) or

charge the lithium battery via a data line .

5

5 .3

.3

.3 RearView

RearView

Finger 4. RearView

( Refer to Figure 4 and insert the lithium batter y properly

in

the right direction. )

6

5.

5. 4

4

4 Accessories

Accessories

A.

A

lithium battery （Model: GSP053759, rated voltage

3.7V,

capacity1050mAh)

B.

A

User Manual

C.

A

power adapter

D.

A

data line

E.

A

disk (PC software)

F.

An adult- oximeter probe （Model:CMS-03 ）

An

infant-oximeter probe ( May purchase selectively)

6

6 Operating

Operating

Operating Guide

Guide

6.1

6.1 Application

Application

Application method

method

A.

a)

a) Open the

lid

of battery box and put the battery

in

side , then close.

b)

b) Put the suitable probe into the jack on the right side of the oximeter. (The probe is limited to be

produced by our company; never re place

it

with the similar ones by other manufacturers ).

c)

c) Put the finger into the probe .

d)

d) Press the "power on/off button" long about a few seconds,the power is on,and the device will

start to self-inspect .The device displays the measuring interface after self-inspect ing.

e)

e) Do not shake the finger and keep the patient

in

a stable state during the process.

f)

f) The data can be read directly from the screen on the measuring interface.

Fingernails

Fingernails and

and

and the

the

the luminescent

luminescent

luminescent tube

tube

tube should

should

should be

be

be on

on

on the

the

the same

same

same side.

side.

If

If the

the

the alarm

alarm

alarm function

function

function is

is

is on

on

on ,

,

, the

the

the device

device

device will

will

will provide

provide

provide midium-priority

midium-priority

midium-priority alarm

alarm

alarm signal

signal

signal when

when

probe

probe or

or

or finger

finger

finger is

is

is out

out

out 。I

I

I ntermittent

ntermittent

ntermittent alarm

alarm

alarm will

will

will occur

occur

occur and

and

and the

the

the user

user

user interface

interface

interface presents

presents

"FINGER

"FINGER OUT".

OUT".

Medium

Medium priority

priority

priority indicating

indicating

indicating that

that

that prompt

prompt

prompt operator

operator

operator response

response

response is

is

is required.

required.

Figure 5

（Actual probe may be different with the probe as figure 5,please accept the actual probe with the

device ）

7

B.

B. Change

Change

Change display

display

display direction:

direction:

On the measuring interface, press the"screen change button"can change the display direction.

C.

C. Pause

Pause

Pause alarm:

alarm:

a)

a) Alarm including the alarm of measure data's going beyond the limits, the alarm of low-voltage,

the alarm of probe or finger's out of position.

b)

b) When alarm is on,press the"alarm pause button"can pause the alarm,it can renew alarm

in

about

60s,and

if

pressing the"alarm pause button" Again with

in

60s,it can renew alarm .

c)

c) If you want to turn off the alarm for good, you should enter the menu for operation.

D.

D. Menu

Menu

Menu operations:

operations:

On the measuring interface,press the"menu button"can enter the menu of figure 6.Users can adjust

the setting through the main menu, such as alarm, pulse sound indication, backlight,data storage,data

transmission (with the use of data line),the specific method is as follows:

Figure 6. Main Menu Interface

a)

a) Alarm

Alarm

Alarm setting

setting

On the main menu interface,press the"up button"or"down button",move the menu choice bar to

"

Alarm

"

,then press the"menu button"to enter the alarm setting menu of figure

7:

Figure 7. Alarm Setting Menu

a.

a. The

The

The highest/lowest

highest/lowest

highest/lowest alarm

alarm

alarm limit

limit

limit setting

setting

Press the"up button"or"down button" to choose the parameter to be adjusted , then press the"menu

button"again to enter the similar dialog box shown as figure 8,then press the"up button"or"down

button"to change data. Each p ress of the"up button"or"down button" , the data will raise or descend

for one time accordingly , until

it

gets to the required number , then press the "menu button"for

another time to end the set ting .

If

If the

the

the alarm

alarm

alarm function

function

function is

is

is on

on

on ,

,

, the

the

the device

device

device will

will

will provide

provide

provide midium-priority

midium-priority

midium-priority alarm

alarm

alarm signal

signal

signal when

when

when the

the

data

data of

of

of SpO

SpO

2

or

or pulse

pulse

pulse rate

rate

rate is

is

is beyond

beyond

beyond the

the

the limit.

limit.

limit. Intermittent

Intermittent

Intermittent alarm

alarm

alarm will

will

will occur

occur

occur and

and

and the

the

8

measurement

measurement shows

shows

shows in

in

in yellow.

yellow.

Medium

Medium priority

priority

priority indicating

indicating

indicating that

that

that prompt

prompt

prompt operator

operator

operator response

response

response is

is

is required.

required.

When

When operating

operating

operating at

at

at the

the

the beginning,

beginning,

beginning, the

the

the operator

operator

operator inserts

inserts

inserts his

his

his finger,

finger,

finger, and

and

and setup

setup

setup the

the

the Spo2

Spo2

Spo2 ALM

ALM

HI

HI lower

lower

lower than

than

than the

the

the current

current

current measured

measured

measured value,

value,

value, then

then

then the

the

the machine

machine

machine will

will

will start

start

start alarm.

alarm.

alarm. The

The

The pulse

pulse

pulse rate

rate

alarm

alarm test

test

test is

is

is the

the

the same

same

same with

with

with the

the

the above.

above.

Figure 8.

b.

b. The

The

The a

a

a larm

larm

larm state

state

state setting

setting

Press the"up button"or"down button", move the menu choice bar to

"

Alarm ", then choose the alarm

state (on/off) by pressing the "menu button" , choose “ on ” to start the alarm function, and choose

“ off ” to close

it

for good.

b)

b) Pulse

Pulse

Pulse sound

sound

sound indication

indication

indication setting

setting

On the main menu interface,press the"up button"or"down button",move the menu choice bar

to"Pulse Sound", then choose the pulse sound indication state (on/off) by pressing the "menu

button" ,press “ on ” to start the function, and press “ off ” to close it.

c)

c) Backlight

Backlight

Backlight adjustment

adjustment

On the main menu interface,press the"up button"or"down button",move the menu choice bar to

"

Brightness ",then press the"menu button" to change the number

in

order to adjust the brightness of

screen.

d)

d) Data

Data

Data storage

storage

storage setting

setting

This device has the function of 24 hours data storage ,

it

has the capability of accurately storing

pulse rate and SpO

2

data, then transmit the data to computer with the data line for replay and

analysis.

a.

a. On the main menu interface,press the"up button"or"down button",move the menu choice bar

to" Record",then press the"menu button"again to enter the dialog box of figure 9:if

it

is

in

recording

state,the"Stop"is displayed on menu;if

it

is not

in

recording state,the" Start "is displayed on menu.

Figure 9.

9

b.

b. When the" Start "is displayed on the menu,if the memory still have the former data

in

storage ,the

"

Do you really want to recover the memory" dialog box will be displayed when pressing the

"menu"button ,then press the"up button"or"down button"to choose setting,then press the"menu

button"to confirm setting,the dialog box will be displayed as figure 10:It needs to set the starting

time for data storage by users , users can change the setting value by pressing the"up button"or"down

button",and confirm the setting value by pressing the"menu button", the black cursor will move to

next place after setting.When the black cursor move to"Yes"(store) or "No"(don't store), press the"up

button"or"down button"to choose setting,then press the"menu button"to confirm setting.

c.

c. When the" Stop "is displayed on menu,the ＂Do you really want to stop recording ＂dialog box

will be displayed when pressing the "menu button".then press the"up button"or"down button"to

choose setting,then press the"menu button"to confirm setting.

Figure 10.

d.

d. If the data storage function is being turned on, when return to the measuring interface, a red

"REC"sign and a flashing red dot would appear on screen, which means the device is

in

a state of

storing.

e.

e. In the state of storing, whatever interface the device is on (measuring interface, menu interface),

the sign "Recording" would appear on the screen

in

30 seconds, and then the screen will be

automatically shut down. If pressing any button(power on/off excluded) at this moment, the sign

"Recording" would appear on the screen, and then the screen will be automatically shut down

again;

if

pressing the "power on/off button", the device would return to the former interface.

f.

f. I f turning on the data storage function, the former data storage will be automatically removed.

g.

g. In the state of data storing, after the screen is automatically shut down, the pulse sound

indication would be off for saving power.

h.

h. When the storage space is full,

it

displays “ Memory is full ” on the screen, and then shut down

in

a few seconds.

But

it

will still display “ Memory is full ” by the next time you turn on the device on

the purpose of warning the user,

if

press any button(power on/off excluded) again,

it

will enter the

measuring interface.

e

e）Stored

Stored

Stored data

data

data transmission

transmission

transmission setting

setting

Firstly, please install the affiliated software into the computer, and then two icons would appear on

the desktop after installation. The icon of SpO2 is a program for receiving real-time data which is

shown as figure 11 ; the icon of SpO2 Review is a program for receiving stored data which is shown

as figure 12 .

Figure 11.SpO2 program

10

Figure 12. SpO2 Review program

a.

a. Please connect the device to computer with the affiliated data line , then double click" SpO2

Review"icon to start the program .

b.

b. On the main menu interface,press the"up button"or"down button"

in

order to move the menu

choice bar to" Upload", then press the"menu button"to transmit the stored data to computer for replay

and analysis.

c.

c. In the state of storing,

it

is not applicable for the users to upload the stored date to computer.

d.

d. When the stored data is being uploaded ,the screen displays as figure 13.

Figure 13.

e.

e. When the upload of stored data is finished, the device will automatically return to the main

menu, and the menu choice bar will move to "Exit"automatically as well.

f

f）Exit

Exit

Exit the

the

the main

main

main menu

menu

On the main menu interface,press the"up button"or"down button"

in

order to move the menu choice

bar to"Exit",then press the"menu button"to exit the main menu.

E.

E. Real-time

Real-time

Real-time data

data

data transmission

transmission

a)

a) Please connect the device with computer by the data line which is equipped with the device,then

double click "SpO2"icon to open"SpO2"program.

b)

b) The data can be displayed on computer screen

in

a few seconds.

c)

c) When you unplug the data line from computer, there is a dialog box "Save data at view"

appearing on the desktop,

in

which you can input some patient's basic information.

F.

Charge

There are two kinds of charging methods:

a)

a) Connect the device with computer by data line, then the device should be under charging state.

b)

b) Connect the device with power supply by power adaptor, then the device should be under

charging state.

c)

c) The five status of b attery power are shown as follows:

11

d

d）When charging the battery

in

the state of power off, the sign of battery status still exists on the

screen, but

it

will disappear

in

about 60 seconds for saving power. However, the sign will appear

again

if

you press any button(power on/off excluded) at this moment.

If

If the

the

the alarm

alarm

alarm function

function

function is

is

is on

on

on ,

,

, the

the

the device

device

device will

will

will provide

provide

provide high-priority

high-priority

high-priority alarm

alarm

alarm signal

signal

signal when

when

when the

the

battery

battery is

is

is in

in

in low

low

low power

power

power status

status

status .Intermittent

.Intermittent

.Intermittent alarm

alarm

alarm will

will

will occur

occur

occur and

and

and the

the

the battery

battery

battery icon

icon

icon turns

turns

turns red

red

red in

in

the

the state

state

state of

of

of flashing.

flashing.

High

High priority

priority

priority indicating

indicating

indicating that

that

that immediate

immediate

immediate operator

operator

operator response

response

response is

is

is required.

required.

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 3 for reference), or

else

it

may result

in

inaccurate measure.

C.

C. The SpO

2

sensor and photoelectric receiving tube should be arranged

in

a way with the subject

’

s arteriole

in

a position there between .

D

D .

.

.The SpO

2

sensor should not be used at a location or limb tied with arterial canal or blood pressure

cuff or receiving intravenous injection.

E

E .

.

.Do not fix the SpO

2

sensor with adhesive or else

it

may result

in

venous pulsation and inaccurate

measure of SpO

2

a nd pulse rate .

F

.

.Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby

light, infrared heater, direct sunlight and etc.

G

.

.Strenuous action of the subject or extreme electrosurgical interference may also affect the

accuracy.

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

Power supply by battery only, and battery status is full

Battery status is not full

Battery status is draining away

Low power alarm indication （Please cha r ge the battery ）

the four status above shows

dynamically

in

turn

Battery is under charging

12

thiosalicylic hemoglobin, and some with icterus problem, the SpO

2

determination by this monitor

may be inaccurate.

C

C .

.

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

factor blamed for serious error of SpO

2

measure.

D

D .

.

.As the SpO

2

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

some patients with serious anemia may also report good SpO

2

measurement.

7

7 M

M

M aintain

aintain

aintain 、transportation

transportation

transportation and

and

and storage

storage

7.1

7.1 Cleaning

Cleaning

Cleaning and

and

and Disinfecting

Disinfecting

Using medical alcohol to disinfect the device, nature dry or clean

it

with clean soft cloth.

7.2

7.2 Maintain

Maintain

A.

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

B.

B. Please recharge the battery when the screen shows .

C.

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

months when

it

is no regular used. It can extend the battery life following this guidance.

D.

D. Please take out the batteries

if

the oximeter is not

in

use for a long time.

E.

E. The 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.

B.

B. The packed device should be stored

in

room with no corrosive gases and good ventilation.

Temperature: - 4 0 ° C~ 60 ° C ; Humidity: ≤ 95%

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

1. The finger is not properly positioned.

2. The patient

’

s SpO

2

is too low to be

detected.

1. Place the finger properly and

try again.

2. Try again ; Go 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

stabl y

y

1. The finger is not placed inside deep

enough.

2. The finger is shaking or the patient is

moving.

1. Place the finger properly and

try again.

2. Let the patient keep calm

The

The device

device

device can

can

can not

not

be

be turn

turn

turn ed

ed

ed on

on

1. The battery is drained away or almost

drained away .

2 . The battery is installed incorrectly.

3. The malfunction of the device.

1. Please recharge the battery

2. Please Install the battery

again.

3 . Please contact the local service

center.

13

The

The display

display

display is

is

is off

off

suddenly

The battery is drained away or almost

drained away .

Please recharge the battery

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

1.The battery is not full charged.

2. The battery is broken

1. Please recharge the battery

2. 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 broken

Please contact the local service

center.

9

9 Key

Key

Key of

of

of Symbols

Symbols

Signal Description

Warning – See User Manual

The pulse oxygen saturation(%)

PRbpm Pulse rate (bpm)

Close the alarm sound indication forever

Pause the alarm sound indication

Open the alarm sound indication

Close the pulse sound indication

Open the pulse sound indication

Power on/off button

Alarm pause button/up button

Menu button

Screen change button/down button

Type

BF

14

SN Serial number

1. the finger clip falls off ( no finger inserted) ]

2. Probe error

3. Signal inadequacy indicator

IPX1 Ingress of liquids rank

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.

10

10 Function

Function

Function Specification

Specification

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

SpO

2

Parameter

Parameter Specification

Specification

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

Accuracy 7 0% ～100 % ：± 2% ,Below 70% unspecified.

Average value

Calculate the Average value

in

every 4 measure value.

The deviation between average value and true value

does not exceed 1%.

Pulse

Pulse Parameter

Parameter

Parameter Specification

Specification

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

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

Average pulse rate

Moving calculate the Average pulse rate every 4

cardio-beat

,

s

cycle .

The deviation between average value and true value

does not exceed 1%

Safety

Safety T ype

Type

Type Interior Battery ，ＢＦ Type

Pulse

Pulse Intensity

Intensity

15

Range

Continuous bar-graph display, the higher display

indicate the stronger pulse.

Battery

Battery Requirement

Requirement

Voltage

3 .7 rechargeable lithium battery × 1

Batter

Batter y

y

y working

working

working life

life

Charge and discharge no less than 500 times.

Power

Power Adapter

Adapter

Input

Voltage

100 to 240

VAC,

50/60 Hz

Output voltage 5 VDC

Output current 250mA

Output power 1.25 W

O

O ximeter

ximeter

P

robe

Wavelength :660nm 880nm

Dimensions

Dimensions and

and

and Weight

Weight

Dimensions 87 (

L

) × 45 ( W ) × 22 ( H ) mm

Weight

About 175 g (with the lithium battery *1 )

16

Appendix

Appendix 1

1

Guidance

Guidance and

and

and manufacture

manufacture

manufacture ’

’

’ s

s

s declaration-electromagnetic

declaration-electromagnetic

declaration-electromagnetic emission

emission

for

for all

all

all EQUIPMENT

EQUIPMENT

EQUIPMENT and

and

and SYSTEMS

SYSTEMS

Guidance

Guidance and

and

and manufacture

manufacture

manufacture ’

’

s

declaration

declaration –

–

– electromagnetic

electromagnetic

electromagnetic emission

emission

The

Pulse Oximeter ( CMS 60C)

is intended for use

in

the electromagnetic environment specified below. The

customer of the user of the

Pulse Oximeter ( CMS 60C)

should assure that

it

is used

in

such an environment

Emission

Emission test

test

test compliance

compliance

compliance Electromagnetic

Electromagnetic

Electromagnetic environment-guidance

environment-guidance

RF emissions

CISPR 11

Group 1 The

Pulse Oximeter ( CMS 60C)

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 emissions

CISPR 11

Class

B

The

Pulse Oximeter ( CMS 60C)

is suitable foe 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/

f licker emission

IEC 61000-3- 3

Not applicable

Guidance

Guidance and

and

and manufacture

manufacture

manufacture ’

’

’ s

s

s declaration-electromagnetic

declaration-electromagnetic

declaration-electromagnetic 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-electromagnetic

declaration-electromagnetic

declaration-electromagnetic immunity

immunity

The

Pulse Oximeter ( CMS 60C)

is intended for use

in

the electromagnetic environment specified below. The

customer or the user of

the Pulse Oximeter ( CMS 60C)

should assure that

it

is used

in

such an environment

Immunity

Immunity test

test

test IEC60601

IEC60601

IEC60601 test

test

test level

level

level Compliance

Compliance

Compliance level

level

Electromagnetic

environment

environment -guidance

guidance

Electrostatic

discharge (ESD) IEC

61000-4-2

± 6KV contact

± 8KV

air

± 6KV contact

± 8KV air

Floor s should be wood, concrete or

ceramic tile. If floor are c overed

with synthetic material, the relative

humidity should be at least 30% .

Power frequency

(50Hz) magnetic field

IEC 61000-4-8

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

should be at levels characteristic of

a typical location

in

a typical

commercial or hospital

environment

17

Guidance

Guidance and

and

and manufacture

manufacture

manufacture ’

’

’ s

s

s declaration-electromagnetic

declaration-electromagnetic

declaration-electromagnetic 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-SUPPORT ING

Guidance

Guidance and

and

and manufacture

manufacture

’

s

s declaration-electromagnetic

declaration-electromagnetic

declaration-electromagnetic immunity

immunity

The

Pulse Oximeter ( CMS 60C)

is intended for use

in

the electromagnetic environment specified below. The

customer or the user of the

Pulse Oximeter ( CMS 60C)

should assure that

it

is used

in

such an environment

Immunity

Immunity test

test

IEC60601

test

test level

level

Compliance

level

Electromagnetic

Electromagnetic environment

environment

environment -guidance

guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3V

rms

150kHZ to

80MHZ

3V/m

80MHz to

2.5GHz

3V

rms

3V/m

Portable and mobile RF communication equipment should be

used no closer to any part of the

Pulse Oximeter ( CMS 60C)

,

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

PEd

⎥

⎦

⎤⎢

⎣

⎡=

1

5 .3

80MHz to 800MHz

PEd

⎥

⎦

⎤⎢

⎣

⎡=

1

7

800MHz to 2.5GHz

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).

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

80MHz and 800MHz, 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 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

Pulse Oximeter ( CMS 60C)

is used

exceeds the applicable RF compliance level above, the

Pulse Oximeter ( CMS 60C)

should be observed to

verify normal operation. If abnormal performance is observed, additional measures may be necessary, such

as reorienting or relocating the

Pulse Oximeter ( CMS 60C)

.

b

Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.

Contec CMS60C User manual

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