Contec Cms50ew User manual

I

II

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 . 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 .

W

ARNING:

�

�U

U

U ncomfortable

ncomfortable

ncomfortable 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 m

m

m icrocirculat

icrocirculat

icrocirculat ion

ion

ion 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.

T

T he

he

he 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

tissue .

.

�

�The

The

The light

light

light (the

(the

(the infrared

infrared

infrared is

is

is in

in

in visible

visible

visible )

)

) 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 c

c

c au

au

au t

t

t ion

ion

ion .

.

This

This

This device

device

device is

is

is not

not

not intended

intended

intended for

for

for treatment

treatment

treatment .

.

III

CONTENTS

1. Safety ............................................................................................................................ 1

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

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

1.3. Hazards .................................................................................................................... 2

2. Overview ........................................................................................................................ 3

2.1. Features ................................................................................................................... 3

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

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

3. Principle ......................................................................................................................... 3

4. Technical specifications .................................................................................................... 4

4.1. Main performance ..................................................................................................... 4

4.2. Main Parameters ....................................................................................................... 4

5. Installation ...................................................................................................................... 5

5.1. View of the front panel ............................................................................................... 5

5.2. Installing the hanging rope .......................................................................................... 5

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

6. Operating Guide .............................................................................................................. 6

6.1. Application method .................................................................................................... 6

6.2. Attention for operation ............................................................................................. 10

6.3. Clinical restrictions .................................................................................................. 10

7. Maintain 、transportation and storage ............................................................................... 10

7.1. Cleaning and disinfecting .......................................................................................... 10

7.2. Maintain ................................................................................................................. 10

7.3. Transportation and storage ........................................................................................ 11

8. Troubleshooting ............................................................................................................. 11

9. Key of Symbols ............................................................................................................. 11

10. Function Specification .................................................................................................. 12

Appendix ............................................................................................................................ 13

1

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 at least once a week. Please stop using the

oximeter

if

there is obvious damage to the device.

Necessary maintenance must be performed by qualified service engineers

ONLY.

The users are

not permitted to service the device 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

environment with inflammable gas such as

some ignitable anesthetic .

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

CT.

DO NOT strand the lanyard

in

order to avoid device drop and damage. The lanyard is made of

non-sensitive material. Please do no t use lanyard

if

the user is allergic to lanyard.Do not enwind neck

with lanyard

in

order to avoid accident.

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.

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 choose the battery cha r gers which should be ensured compliance with the requirements

of IEC 60 60 1-1 , or else

it

may damage the device.

P lease don't use the device

in

the course of charging .

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

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

2

1.3.

1.3. Hazards

Hazards

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

temperature and moisture.

If the oximeter gets wet, please stop using

it

immediately .

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 ℃ .

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

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

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 ( optional ) .

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 moment 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 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 (default

setting) for good .This function could be turned on through menu operation

if

you need. 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.

Do not contort or drag the connection of the device.

3

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 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

.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.

The problem of overrating would emerge when the patient is suffering from toxicosis which

caused by carbon monoxide, the device is not recommended to be used under this circumstance.

2

2 .3

.3

.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

:3

0 % ～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 Characteristic s of Reductive

4

Hemoglobin (

Hb

) and Oxyhemoglobin (

Hb

O

2

)

in

glow & near-infrared zones. Operation principle of

the device is: Photoelectric O xyhemoglobin I nspection

T

echnology 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 per spective 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

4 .1

.1

.1 .

.

. Main

Main

Main performance

performance

A. SpO

2

value display

B. P ulse rate value display , bar graph display

C. Pulse waveform display

D.

L

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

to low-voltage

E.

A

utomatically power off function: when the device is under the state of measuring interface

(without external probe),

it

will automatically power off within 5 second s

if

the finger falls out of

probe.

F. The display mode can be changed

G. Screen brightness can be changed

H. With pulse rate sound indicat ion

I. With alarm function

J

J.With SpO

2

and pulse rate value record function , the record data can be uploaded to computer .

K. It can be connected with an external oximeter probe ( optional )

L

L.Data can be observe d on computers synchronously by PC software

M

M. With two kinds of data transmission mode: dat a line and Bluetooth .

4

4 .2

.2

.2 .

.

. Main

Main

Main Parameters

Parameters

A.

A. Measuremen

Measuremen

Measuremen t

t

t of

of

of SpO

SpO

2

Measurement Range: 0 % ～100 ％

Accuracy:70~100%, ± 2%;0~69%,unspecified

B.

B. Measurement

Measurement

Measurement of

of

of pulse

pulse

pulse rate

rate

Measurement Range: 30 bpm~250bpm

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

5

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 the 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:

:

DC 3.6

V

~ 4.2V .

G.

G. Optical

Optical

Optical Sensor

Sensor

Red light (wavelength is 660nm ，6.65mW)

Infrared (wavelength is 880nm, 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

5 .1

.1

.1 .

.

. View

View

View of

of

of the

the

the front

front

front panel

panel

Figure 2. F ront

V

iew

5

5 .2

.2

.2 .

.

. Installing

Installing

Installing the

the

the hanging

hanging

hanging rope

rope

A. P ut the thinner side of the rope through the hole.

B

B.P ut the wider side of the rope through the thinner side which has been put through the hole, then

tighten it.

5

5 .

.

. 3

3

3 .

.

. Accessories

Accessories

A.

A. a hanging rope

B.

B. a user manual

C.

C. a power adapter

D.

D. a data line

E.

E. a disk (PC software)

F.

an oximeter probe ( optional )

6

6.

6. Operating

Operating

Operating Guide

Guide

6

6 .1

.1

.1 .

.

. Application

Application

Application method

method

6.1.1

6.1.1 Measurement

Measurement

A

Squeeze the clamp, put a finger into the rubber hole, then release it.

B Press the b utton on the front panel until the device turns on.

C Do not shake the finger and keep the patient

in

a stable state during the process.

D The data can be read directly from the screen

in

the measuring interface.

6.1.2

6.1.2 Lay

Lay

Lay finger

finger

The right method of laying finger is as figure 3 or figure 4.

figure 3

( Actual probe may be different from the probe as figure 3 ,please accept the actual probe with the

device )

Figure 4

Fingernails

Fingernails and

and

and the

the

the luminescent

luminescent

luminescent tube

tube

tube should

should

should be

be

be in

in

in the

the

the same

same

same side.

side.

If

If the

the

the alarm

alarm

alarm function

function

function is

is

is on,the

on,the

on,the device

device

device will

will

will provide

provide

provide medium-priority

medium-priority

medium-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

presents "FINGER

"FINGER

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.

6.1.3

6.1.3 Change

Change

Change display

display

display mode:

mode:

I n the measuring interface, you can change the display mode by short pressing the button .

7

6.1.4

6.1.4 Pause

Pause

Pause alarm:

alarm:

A Alarm includ es the alarm of measure data's going beyond the limits, the alarm of low- power ,

and the alarm of finger out.

B I n the measuring interface,

if

the alarm function is on, during the period of alarming, alarm can

be suspended by short pressing the button, but the function will be renewed

in

about 60 seconds.

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

6.1.5

6.1.5 Menu

Menu

Menu operations:

operations:

In the measuring interface ,the display direction can be changed by pressing the button with a short

push (click) . T here are four modes of data

di

splay that can be viewed.

Press the button with a prolonged push (1 second) to enter the Settings Menu I nterface (see Figure

5 ). Please

Please

Please Note:

Note:

Note: When the display direction is lengthways , you can not enter the main menu

interface.C lick the power button to switch to landscape orientation.

The user can setup the following content

in

the Settings M enu

:

B acklight Brightness , A larm

setting,ID setting , data stor age ( R ecord) , turning on/off Bluetooth . T he specific operation methods

are as follow s

:

Please note

in

the Settings Menu:

CLICK

CLICK = short p ush of button and PRESS

PRESS

PRESS = prolonged p ush of power button (1sec)

Figure 5 Main Menu Interface

A

A Backlight

Backlight

Backlight adjustment

adjustment

I n the main menu interface, c lick the button to select “ Brightness ” , P ress the power button and hold

to adjust the backlight br ightness.

B

B Alarm

Alarm

Alarm setting

setting

I n the main menu interface, c lick the power button to select “ Alarm ” , P ress the power button (1sec)

to enter the alarm setting interface as shown

in

F

i

g ure 6

:

a)

a) Adjust

Adjust

Adjust ing

ing

ing the

the

the high

high

high and

and

and low

low

low limit

limit

limit s

s

s of

of

of alarm

alarm

alarm s

s

Click button to change the position of menu selection bar,and press button to set menu item.Move

the selection bar to “Dir ”,and press button to choose value adjusting direction

:

up or down.By

pressing button operation,the user could adjust the value of SpO

2

high limit (SPO

2

ALM HI), SpO

2

low limit (SPO

2

ALM LO), Pulse rate high limit (PR ALM HI), Pulse rate low limit (PR ALM

LO) .The alarm low limit can't be beyond the alarm high limit.The SpO

2

alarm range is

0%~100% ,the pulse rate alarm range is 0bpm~254bpm .

8

If

If the

the

the alarm

alarm

alarm function

function

function is

is

is on,the

on,the

on,the device

device

device will

will

will provide

provide

provide medium-priority

medium-priority

medium-priority alarm

alarm

alarm signal

signal

signal when

when

when the

the

measure

measure value

value

value 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

the measurement

measurement

measurement shows

shows

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.

b)

b) The

The

The a

a

a larm

larm

larm state

state

state setting

setting

Click the button to select “ Alarm ” , then p ress the button to choose alarm on / off . Choose “ on ” to

turn on the alarms and “ off ” to turn off the alarms.

Figure 6 Alarm Setting Menu

c)

c) Pulse

Pulse

Pulse sound

sound

sound indication

indication

indication setting

setting

Click the button to select “ Pulse Sound ” , then p ress button to choose to have the Pulse Sound (heart

beat) “ on ” or “ off ” .

d)

d) Exit

Exit

Exit the

the

the Alarm

Alarm

Alarm setting

setting

setting s

s

Click button to select “ EXIT ” , then P ress button to exit the A larm Settings Menu.

C

C ID

ID

ID setting

setting

The user could set device ID by software

"

SpO

2

Assistant ".The user could set character string

which could only be made of number or letter and not be beyond 7 bits

Figure 7 SpO2 Assistant program

I

I f

f

f the

the

the users

users

users choose

choose

choose to

to

to turn

turn

turn on

on

on the

the

the synchronizing

synchronizing

synchronizing display

display

display function

function

function on

on

on computer,

computer,

computer, it

it

it would

would

probably

probably take

take

take several

several

several seconds

seconds

seconds for

for

for the

the

the data

data

data to

to

to appear

appear

appear on

on

on the

the

the computer

computer

computer screen

screen

D

D Data

Data

Data storage

storage

storage setting

setting

This device can record 24 hour s data including p ulse rate and SpO

2

value accurately and upload the

data to the computer for display and analysis.

a)

a) I n the main menu interface, click button to move the selection bar to "Record" item,then press

button to enter the record beginning time setting dialog box as figure 8.

b)

b) Click button to move the underline to the number that you want to set,then press button to set

time. After setting time,move the underline to "Y",then press button to

exi

t the “ time setting menu ” ,

and record ing will begin . If move the underline to "N",then press button to cancel record, and the data

stored

in

memory will not be delete d .

9

c)

c) If the data storage function is 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

record.

d)

d) In the state of record ,whatever interface the device is

i

n (measuring interface, menu interface),

the sign "Recording" would appear on the screen

in

30 seconds, then the screen will be automatically

shut down. If click the button at this moment, the sign "Recording" would appear on the screen, and

then the screen will be automatically shut down again ;

if

press the button ,the device would return to

the former interface.

e)

e) I f turning on the data storage function, the former saved data will be automatically delete d .

f)

f) When recording , the pulse sound indication would be turned off for saving power , after the

screen is shut down automatically .

g)

g) W hen 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 the button again,

it

will enter the measuring interface.

Figure 8

ESet

Set

Set Bluetooth

Bluetooth

Bluetooth state

state

M ove the menu selection bar to" Bluetooth

"

item,then press button to turn on/off Bluetooth.If there is

no data transmission,the Bluetooth will be closed 5 minutes later..

When

When the

the

the data

data

data is

is

is being

being

being transmitted

transmitted

transmitted between

between

between device

device

device and

and

and computer,the

computer,the

computer,the user

user

user can't

can't

can't change

change

the

the state

state

state of

of

of "Bluetooth".

"Bluetooth".

FExit

Exit

Exit the

the

the main

main

main menu

menu

Click button to select “ EXIT ” , then P ress button to exit the Main Menu.

6.1.6

6.1.6 PC

PC

PC software

software

software operation

operation

By PC software,the user could upload Real-time measure data and storage data.Here the user

should connect the device to the computer by the USB data line or Bluetooth adapter.It is

recommended to use the Bluetooth adapter which uses CSR as main chip. Please refer to

"

SpO2

Assistant user manual

"

for detailed operation explanation.

The

The user

user

user can't

can't

can't use

use

use the

the

the USB

USB

USB data

data

data line

line

line or

or

or Bluetooth

Bluetooth

Bluetooth adapter

adapter

adapter at

at

at the

the

the same

same

same time.

time.

time. Please

Please

Please don't

don't

pull

pull out

out

out the

the

the USB

USB

USB data

data

data line

line

line or

or

or Bluetooth

Bluetooth

Bluetooth adapter

adapter

adapter when

when

when the

the

the data

data

data is

is

is being

being

being transmitted

transmitted

transmitted between

between

device

device and

and

and computer.

computer.

6.1.7

6.1.7 Charge

Charge

There are two kinds of charg e method:

A

AConnect the device to computer with data line, then the device should be

in

charg e state.

B

BConnect the device to power supply with power adaptor, then the device should be

in

charg e

state.

CW hen the device is

in

the state of battery charging, the indication light is on, when the battery

capacity is full, the indication light would be off accordingly.

If

If the

the

the alarm

alarm

alarm function

function

function is

is

is on,the

on,the

on,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

10

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

6 .2

.2

.2 .

.

. Attention

Attention

Attention for

for

for operation

operation

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 and 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

measure of SpO

2

, and pulse rate .

F.

Excessive ambient light may affec t 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

6 .3

.3

.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

7 .1

.1

.1 .

.

. Cleaning

Cleaning

Cleaning and

and

d

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. Please clean and disinfect the device before using according to the User Manual( 7 .1).

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. The device needs to be calibrated once a year (or according to the calibrating program of hospital).

11

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: -40 ° C~60 ° C; Relative Humidity

:

≤ 95%

8.

8. Troubleshooting

Troubleshooting

Trouble

Trouble Possible

Possible

Possible Reason

Reason

Reason Solution

Solution

The

The SpO2

SpO2

SpO2 and

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 SpO2 is too low to be

detected.

1. Lay 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 laid inside deep

enough.

2. The finger is shaking or the patient is

moving.

1. Lay 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 batteries are drained or almost

drained.

2 . The device

’

s malfunction

1. Please recharge the battery

2. Please contact the local

service center.

The

The display

display

display is

is

is off

off

suddenly

1. T his device is set to be automatically

power off within 5 seconds when

it

cannot

detect any signal (without external probe)

2. The batter y is drained away or almost

drained away .

1. Normal

2. Please recharge the battery

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 – S ee User Manual

% SpO

2

T he pulse oxygen saturation(%)

bpm Pulse rate (bpm)

Full-voltage

12

Low-voltage

Close the alarm sound indication

Pause the alarm sound indication

Open the alarm sound indication

Close the pulse sound indication

Open the pulse sound indication

menu button /p ower button / function button

USB

T

ype

BF

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)

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 （bpm ）3-digit digital OLED display

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

SpO2

SpO2 Parameter

Parameter

Parameter Specification

Specification

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

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

13

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 ～250 bpm, (the resolution is 1bpm)

Accuracy ±2bpm or ±2% (select the 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 Type

Type

Type Interior Battery ，

BF

Type

Pulse

Pulse Intensity

Intensity

Range

Continuous bar-graph display, the higher display indicate

the stronger pulse .

Battery

Battery Requirement

Requirement

Voltage

3.7 rechargeable lithium battery × 1 (The red wire on the battery denotes anode,the black wire

on the battery denotes cathode.)

Battery

Battery 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 57(L) × 32(W) × 30 (H) mm

Weight About 50g (with the lithium battery*1)

14

Appendix

State Alarm condition delay Alarm signal generation delay

Low voltage alarm 1s 20ms

Spo

2

alarm 330ms 20ms

Pulse rate alarm 330ms 20ms

Probe error alarm 16ms 20ms

Contec CMS50EW User manual

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