MedToolz PO300 Instructions To User

I

n

s

truction

s

to U

s

er

Dear u

s

er

s

, thank you very much for purcha

s

ing the Pul

s

e Oximeter.

Thi

s

M

anual i

s

written and compiled in accordance with the council directive

M

DD93/42/EEC for

medical device

s

and harmonized

s

tandard

s

. In ca

s

e of modification

s

and

s

oftware upgrade

s

, the

information contained in thi

s

document i

s

ubject to change without notice.

The

M

anual de

s

cribe

s

, in accordance with the Pul

s

e Oximeter’

s

feature

s

and requirement

s

, main

s

tructure, function

s

,

s

pecification

s

, correct method

s

for tran

s

portation, in

s

tallation, u

s

age, operation,

repair, maintenance and

s

torage, etc. a

s

well a

s

the

s

afety procedure

s

to protect both the u

s

er and

equipment. Refer to the re

s

pective chapter

s

for detail

s

.

Plea

s

e read the U

s

er

M

anual carefully before u

s

ing thi

s

product. The U

s

er

M

anual which de

s

cribe

s

the operating procedure

s

hould be followed

s

trictly.Failure to follow the U

s

er

M

anual may cau

s

e

mea

s

uring abnormality, equipment damage and human injury. The manufacturer i

s

NOT re

s

pon

s

ible

for the

s

afety, reliability and performance i

ss

ue

s

and any monitoring abnormality, human injury and

equipment damage due to u

s

er

s

' negligence of the operation in

s

truction

s

. The manufacturer’

s

warranty

s

ervice doe

s

not cover

s

uch fault

s

.

Owing to the forthcoming renovation, the

s

pecific product

s

you received may not be totally in

accordance with the de

s

cription of thi

s

U

s

er

M

anual. We would

s

incerely regret for that.

Thi

s

product i

s

medical device, which can be u

s

ed repeatedly.

WARN

I

NG:

Uncomfortable or painful feeling may appear if u

s

ing the device cea

s

ele

ss

ly, e

s

pecially for

the microcirculation barrier patient

s

.

I

t i

s

recommended that the

s

en

s

or

s

hould not be

applied to the

s

ame finger for over 2 hour

s

.

For the

s

pecial patient

s

, there

s

hould be a more prudent in

s

pecting in the placing proce

ss

.

The device can not be clipped on the edema and tender ti

ss

ue.

The light (the infrared i

s

invi

s

ible) emitted from the device i

s

harmful to the eye

s

,

s

o the

u

s

er and the maintenance man

s

hould not

s

tare at the light.

Te

s

tee can not u

s

e enamel or other makeup.

Te

s

tee

’

s

fingernail can not be too long.

Plea

s

e refer to the correlative literature about the clinical re

s

triction

s

and caution.

Thi

s

device i

s

not intended for treatment.

The U

s

er

M

anual i

s

publi

s

hed by our company. All right

s

re

s

erved.

I

CONTENTS

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

1.1. In

s

truction

s

for

s

afe operation

s

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

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

1.3. Hazard

s

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

2. Overview ........................................................................................................................................ 2

2.1. Feature

s

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

2.2.

M

ajor application

s

and

s

cope of application ....................................................................... 3

2.3. Environment requirement

s

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

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

4. Technical

s

pecification

s

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

4.1.

M

ain performance ............................................................................................................... 4

4.2.

M

ain Parameter

s

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

5. In

s

tallation ..................................................................................................................................... 5

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

5.2. In

s

talling the hanging rope .................................................................................................. 5

5.3. USB port ............................................................................................................................. 6

5.4. Acce

ss

orie

s

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

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

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

6.2. Attention for operation ...................................................................................................... 11

6.3. Clinical re

s

triction

s

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

7.

M

aintain tran

s

portation and

s

torage .......................................................................................... 12

7.1. Cleaning and di

s

infecting.................................................................................................. 12

7.2.

M

aintain

............................................................................................................................ 12

7.3. Tran

s

portation and

s

torage ................................................................................................ 12

8. Trouble

s

hooting ........................................................................................................................... 12

9. Key of Symbol

s

........................................................................................................................... 13

10. Function Specification ............................................................................................................... 14

Appendix 1 .......................................................................................................................................... 16

Appendix 2 .......................................................................................................................................... 16

II

1. Safety

1.1.

I

n

s

truction

s

for

s

afe operation

s

Check the main unit and all acce

ss

orie

s

periodically to make

s

ure that there i

s

no vi

s

ible

damage that may affect patient’

s

afety and monitoring performance about cable

s

and tran

s

ducer

s

. It

i

s

recommended that the device

s

hould be in

s

pected at lea

s

t once a week. Plea

s

e

s

top u

s

ing the

monitor if there i

s

obviou

s

damage to the device.

Nece

ss

ary maintenance mu

s

t be performed by qualified

s

ervice engineer

s

ONLY. There are no

u

s

er

s

erviceable part

s

and u

s

er

s

are not permitted to

s

ervice the device by them

s

elve

s

.

The oximeter cannot be u

s

ed together with device

s

not

s

pecified in U

s

er’

s

M

anual.Only the

acce

ss

ory that appointed or recommendatory by manufacture can be u

s

ed with thi

s

device.

Thi

s

product i

s

calibrated before leaving factory.

1.2. Warning

Explo

s

ive hazard—DO NOT u

s

e the oximeter in environment with inflammable ga

s

uch a

s

ome ignitable ane

s

thetic agent

s

.

DO NOT u

s

e the oximeter while the te

s

tee mea

s

ured by

M

RI and CT.

Be careful with the u

s

e of the lanyard cord. Improper u

s

e of the lanyard cord will cau

s

e device

damage not covered under the manufacturer’

s

warranty. Swinging the device by the lanyard cord

will void the warranty. Plea

s

e do not u

s

e lanyard cord if allergic to lanyard cord.

The di

s

po

s

al of

s

crap in

s

trument and it

s

acce

ss

orie

s

and packing

s

(including battery, pla

s

tic

bag

s

, foam

s

and paper boxe

s

)

s

hould follow the local law

s

and regulation

s

.Plea

s

e check the packing

before u

s

e to make

s

ure the device and acce

ss

orie

s

are totally in accordance with the packing li

s

t, or

el

s

e the device may have the po

ss

ibility of working abnormally.

Plea

s

e choo

s

e the acce

ss

orie

s

which are approved or manufactured by the manufacturer, or

el

s

e it may damage the device.

Plea

s

e choo

s

e the battery charger

s

which

s

hould be en

s

ured compliance with the requirement

s

of IEC 60601-1, or el

s

e it may damage the device.

Plea

s

e don't u

s

e the device in the cour

s

e of charging.

Plea

s

e don't mea

s

ure thi

s

device with functional te

s

ter for the device'

s

related information.

1.3. Hazard

s

Keep the oximeter away from du

s

t, vibration, corro

s

ive

s

ub

s

tance

s

, explo

s

ive material

s

, high

temperature and moi

s

ture.

If the oximeter get

s

wet, plea

s

e

s

top u

s

ing it immediately.

When it i

s

carried from cold environment to warm or humid environment, plea

s

e do not u

s

e it

immediately

DO NOT operate key

s

on front panel with

s

harp material

s

.

High temperature or high pre

ss

ure

s

team di

s

infection of the oximeter i

s

not permitted. Refer to

1

U

s

er

M

anual in the relative chapter (7.1)for in

s

truction

s

of cleaning and di

s

infection.

Do not immer

s

e the oximeter in liquid. When it need

s

cleaning, plea

s

e wipe it

s

urface with

di

s

infectant

s

olution u

s

ing a

s

oft cloth. Do not

s

pray any liquid directly onto the device.

When cleaning the device with water, the temperature

s

hould be lower than 60℃.

A

s

to the finger

s

which are too thin or too cold, it would probably affect the normal mea

s

ure

of the patient

s

' SpO2 and pul

s

e rate, plea

s

e clip the thick finger

s

uch a

s

thumb and middle finger

deeply enough into the probe.

The update period of data i

s

le

ss

than 5

s

econd

s

, which i

s

changeable according to different

individual pul

s

e rate.

Plea

s

e read the mea

s

ured value when the waveform on

s

creen i

s

equably and

s

teady-going,

Thi

s

mea

s

ured value i

s

optimal value. And the waveform at the moment i

s

the

s

tandard one.

If

s

ome abnormal condition

s

appear on the

s

creen during te

s

t proce

ss

, pull out the finger and

rein

s

ert to re

s

tore normal u

s

e.

The device ha

s

normal u

s

eful life for three year

s

ince the fir

s

t electrified u

s

e.

The hanging rope attached to the device i

s

made from Non- allergy material, if particular

group are

s

en

s

itive to the hanging rope,

s

top u

s

ing it. In addition, pay attention to the u

s

e of the

hanging rope , do not wear it around the neck on the purpo

s

e of avoiding harm to the patient.

Thi

s

device ha

s

the function of alarming, u

s

er

s

can check on thi

s

function according to chapter

6.1 a

s

a reference.

The device ha

s

the function of limit

s

alarming, when the mea

s

ured data i

s

beyond the highe

s

t

or lowe

s

t limit, the device would

s

tart alarming automatically on the premi

s

e of the alarming

function i

s

on.

The device ha

s

the function of alarming, thi

s

function can either be pau

s

ed, or clo

s

ed (default

s

etting) for good.Thi

s

function could be turned on through menu operation if you need.Plea

s

e check

the chapter 6.1 a

s

a reference.

The device may not work for all patient

s

. If you are unable to achieve

s

table reading

s

,

di

s

continue u

s

e.

A flexible circuit connect

s

the two part

s

of the device. Do not twi

s

t or pull on the connection.

2. Overview

The pul

s

e oxygen

s

aturation i

s

the percentage of HbO2 in the total Hb in the blood,

s

o-called the O2

concentration in the blood. It i

s

an important bio-parameter for the re

s

piration. A number of di

s

ea

s

e

s

relating to re

s

piratory

s

y

s

tem may cau

s

e the decrea

s

e of SpO2 in the blood, furthermore,

s

ome other

cau

s

e

s

uch a

s

the malfunction of human body'

s

elf-adju

s

tment, damage

s

during

s

urgery, and the

injurie

s

cau

s

ed by

s

ome medical checkup would al

s

o lead to the difficulty of oxygen

s

upply in

human body, and the corre

s

ponding

s

ymptom

s

would appear a

s

a con

s

equence,

s

uch a

s

vertigo,

impotence, vomit etc. Seriou

s

ymptom

s

might bring danger to human'

s

life. Therefore, prompt

information of patient

s

' SpO2 i

s

of great help for the doctor to di

s

cover the potential danger, and i

s

of

great importance in the clinical medical field. The Pul

s

e Oximeter feature

s

in

s

mall volume, low

power con

s

umption, convenient operation and being portable.It i

s

only nece

ss

ary for patient

s

to put

one of hi

s

finger

s

into a probe for diagno

s

i

s

, and a di

s

play

s

creen will directly

s

how the mea

s

ured

value of pul

s

e oxygen

s

aturation with the high veracity and repetition.

2

2.1. Feature

s

A. Operation of the product i

s

imple and convenient.

B. The product i

s

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

C. Low power con

s

umption

2.2. Major application

s

and

s

cope of application

The Pul

s

e Oximeter can be u

s

ed in mea

s

uring the pul

s

e oxygen

s

aturation and pul

s

e rate through

finger. The product i

s

uitable for being u

s

ed in family, ho

s

pital, oxygen bar, community healthcare,

phy

s

ical care in

s

port

s

(It can be u

s

ed before or after doing

s

port

s

, and it i

s

not recommended to u

s

e

the device during the proce

ss

of having

s

port) and etc.

The problem of overrating would emerge when the patient i

s

uffering from toxico

s

i

s

which

cau

s

ed by carbon monoxide, the device i

s

not recommended to be u

s

ed under thi

s

circum

s

tance.

2.3. Environment requirement

s

Storage Environment

a) Temperature :-40 ℃~+60 ℃

b) Relative humidity :≤95%

c) Atmo

s

pheric pre

ss

ure :500hPa~1060hPa

Operating Environment

a) Temperature:10 ℃~40 ℃

b) Relative Humidity :≤75%.

c) Atmo

s

pheric pre

ss

ure:700hPa~1060hPa

3. Principle

Principle of the Oximeter i

s

a

s

follow

s

: An experience formula of data proce

ss

i

s

e

s

tabli

s

hed taking

u

s

e of Lambert Beer Law according to Spectrum Ab

s

orption Characteri

s

tic

s

of Reductive

Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zone

s

. Operation principle

of the device i

s

: Photoelectric Oxyhemoglobin In

s

pection Technology i

s

adopted in accordance with

Capacity Pul

s

e Scanning & Recording Technology,

s

o that two beam

s

of different wavelength of

light

s

can be focu

s

ed onto human nail tip through per

s

pective clamp finger-type

s

en

s

or. Then

mea

s

ured

s

ignal can be obtained by a photo

s

en

s

itive element, information acquired through which

will be

s

hown on

s

creen through treatment in electronic circuit

s

and microproce

ss

or.

3

Figure 1

4. Technical

s

pecification

s

4.1. Main performance

A.

SpO2 value di

s

play

B.

Pul

s

e rate value di

s

play, bar graph di

s

play

C.

Pul

s

e waveform di

s

play

D.

Low-voltage indication: low-voltage indicator appear

s

before working abnormally which i

s

due

to low-voltage

E.

Automatically power off function: when the device i

s

under the

s

tate of mea

s

uring interface . it

will automatically power off within 5

s

econd

s

if the finger fall

s

out of probe.

F.

The di

s

play mode can be changed

G.

Screen brightne

ss

can be changed

H.

A pul

s

e rate

s

ound indication

I .

With alarm function

J

.

With SpO2 value and pul

s

e rate value of

s

torage, the

s

torage data can be uploaded to computer

s

K

.

Real-time data can be tran

s

mitted to computer

s

4.2. Main Parameter

s

A.

M

ea

s

urement of SpO2

M

ea

s

urement Range:0%~100%

Accuracy:70%~100%,±2%;0%~69%,un

s

pecified

B.

M

ea

s

urement of pul

s

e rate

M

ea

s

urement Range:30bpm~250bpm

Accuracy: ± 2 bpm or ± 2% (

s

elect larger)

C. Re

s

olution

SpO2 : 1%, Pul

s

e rate: 1bpm.

D.

M

ea

s

urement Performance in Weak Filling Condition:

SpO2 and pul

s

e rate can be

s

hown correctly when pul

s

e-filling ratio i

s

0.4%. SpO2 error i

s

± 4%,

pul

s

e rate error i

s

± 2 bpm or ± 2% (

s

elect larger).

E. Re

s

i

s

tance to

s

urrounding light:

4

The deviation between the value mea

s

ured in the condition of man-made light or indoor natural light

and that of darkroom i

s

le

ss

than ±1%.

F. Power

s

upply requirement: : 3.6 V DC ~ 4.2V DC.

G. Optical Sen

s

or

Red light (wavelength i

s

660nm,6.65mW)

Infrared (wavelength i

s

880nm, 6.75mW)

H. Adju

s

table alarm range:

SpO2 0%~100%

Pul

s

e Rate: 0bpm~254bpm

5.

I

n

s

tallation

5.1. View of the front panel

Figure 2. Front View

5.2.

I

n

s

talling the hanging rope

A.

Put the thinner

s

ide of the rope through the hole.

B

.

Put the wider

s

ide of the rope through the thinner

s

ide which ha

s

been put through the hole, then

tighten it.

5

5.3. USB port

Figure 3.

USB port :It i

s

u

s

ed to connect a per

s

onal computer to export the trend data or charge the lithium

battery via a data line.

5.4. Acce

ss

orie

s

A. a hanging rope

B. a u

s

er manual

C. a power adapter (optional)(GT

M

41076-0605;C

M

S0105)

D. a data line

E. a di

s

k (PC

s

oftware)

6. Operating Guide

6.1. Application method

A. Squeeze the clamp, put a finger into the rubber hole, then relea

s

e it.

a) Pre

ss

the Power Button on the front panel until the device turn

s

on.

b) Do not

s

hake the finger and keep the patient in a

s

table

s

tate during the proce

ss

.

c) The data can be read directly from the

s

creen on the mea

s

uring interface.

Fingernail

s

and the lumine

s

cent tube

s

hould be on the

s

ame

s

ide.

I

f the alarm function i

s

on,the device will provide medium-priority alarm

s

ignal when

finger i

s

out .

I

ntermittent alarm will occur and the u

s

er interface pre

s

ent

s

"F

I

NGER OUT".

Medium priority indicating that prompt operator re

s

pon

s

e i

s

required.

6

Figure 4

B. Change di

s

play direction:

On the mea

s

uring interface, you can change the di

s

play direction by pre

ss

ing the button

s

hortly.

C. Pau

s

e alarm:

a) Alarm including the alarm of mea

s

ure data'

s

going beyond the limit

s

, the alarm of low-voltage,

the alarm of finger'

s

out of po

s

ition.

b) On the mea

s

uring interface, if the alarm function i

s

on, during the period of alarming, you can

pau

s

e it by pre

ss

ing the button

s

hortly, but the function will be renewed in about 60

s

econd

s

.

c) If you want to turn off the alarm for good, you

s

hould enter the menu for operation.

D.

M

enu operation

s

:

On the mea

s

uring interface, , the di

s

play direction can be changed by pre

ss

ing the power button with

a

s

hort pu

s

h (click). There are four mode

s

of data di

s

play that can be viewed.

Pre

ss

the power button with a prolonged pu

s

h (1

s

econd) to enter the Setting

s

M

enu Interface (

s

ee

Figure 5). Plea

s

e Note: When the di

s

play direction on the

s

creen i

s

in the Portrait View, you can not

enter the

M

enu Interface, click the power button to

s

witch to Land

s

cape View.

The u

s

er can

s

etup the following parameter

s

in the Setting

s

M

enu – Backlight Brightne

ss

, Alarm

high-low limit

s

, data tran

s

mi

ss

ion, data

s

torage (recording), data upload to computer.

Plea

s

e note in the Setting

s

M

enu:

CL

I

CK =

s

hort pre

ss

of power button and PRESS = prolonged pu

s

h of power button (1

s

ec)

7

Figure 5

M

ain

M

enu Interface

a) Backlight adju

s

tment

On the main menu interface, click the power button to

s

elect “Brightne

ss

”, Pre

ss

the power button

and hold to adju

s

t the backlight brightne

ss

.

b) Alarm

s

etting

On the main menu interface, click the power button to

s

elect “Alarm”, Pre

ss

the power button (1

s

ec)

to enter the alarm

s

etting interface a

s

hown in Figure 6:

a. Adju

s

ting the high and low limit

s

of alarm

s

Click the power button to

s

elect “Dir”, then Pre

ss

the button to choo

s

e Up or Down (thi

s

will be the

direction the value of the high-low limit

s

of SpO2 and pul

s

e rate will be adju

s

ted)

To rai

s

e the SpO2 and pul

s

e rate limit, choo

s

e “Dir” a

s

‘Up’, then Click the power button to

highlight the parameter to be adju

s

ted: SpO2 high limit (SPO2 AL

M

HI), SpO2 low limit (SPO2

AL

M

LO), Pul

s

e rate high limit (PR AL

M

HI), Pul

s

e rate low limit (PR AL

M

LO), Pre

ss

the power

button and hold to adju

s

t the

s

elected limit to the de

s

ired higher value and relea

s

e the power button

once the higher limit ha

s

been reached.

To lower the SpO2 and pul

s

e rate limit, choo

s

e “Dir” a

s

‘Down’, then Click the power button to

choo

s

e the parameter to be adju

s

ted. Pre

ss

the power button and hold to adju

s

t the

s

elected limit to

the de

s

ired lower value and relea

s

e the power button once the lower limit ha

s

been reached.

I

f the alarm function i

s

on,the device will provide medium-priority alarm

s

ignal when the

data of SpO2 or pul

s

e rate i

s

beyond the limit.

I

ntermittent alarm will occur and the

mea

s

urement

s

how

s

in yellow.

Medium priority indicating that prompt operator re

s

pon

s

e i

s

required.

b. The alarm

s

tate

s

etting

Click the power button to

s

elect “Alarm”, then Pre

ss

the power button to choo

s

e alarm on or off,

pre

ss

“ on” to turn on the alarm

s

and “ off” to turn off the alarm

s

.

8

Figure 6 Alarm Setting

M

enu

c. Pul

s

e

s

ound indication

s

etting

Click the power button to

s

elect “Pul

s

e Sound”, then Pre

ss

the power button to choo

s

e to have the

Pul

s

e Sound (heart beat) alarm “on” or “off”.

d. Exit the Alarm

s

etting

s

Click the power button to

s

elect “EXIT”, then Pre

ss

the power button to exit the Alarm Setting

s

M

enu.

c

Data tran

s

mi

ss

ion

s

etting

Fir

s

tly, plea

s

e in

s

tall the affiliated

s

oftware into the computer, and then two icon

s

would appear on

the de

s

ktop after in

s

tallation. The icon of SpO2 i

s

a program for receiving real-time data which i

s

hown a

s

Figure 7; the icon of SpO2 Review i

s

a program for receiving

s

tored data which i

s

hown

a

s

Figure 8.

a. Plea

s

e connect the device to computer with the affiliated data line , then double click the SpO2

icon to

s

tart the program

b. On the main menu interface, Click the power button to

s

elect"U

s

b", then Pre

ss

the power button

to choo

s

e whether tran

s

mit the real-time data to computer which di

s

play

s

the data

s

ynchronou

s

ly or

not, choo

s

e “on” to permit tran

s

mi

ss

ion , choo

s

e “off” to forbid tran

s

mi

ss

ion

c.

When you unplug the data line from computer, there i

s

a dialog box "Save data at view"

appearing on the de

s

ktop, in which you can input

s

ome patient'

s

ba

s

ic information.

Figure 7 SpO2 program

Figure 8 SpO2 Review program

I

f the u

s

er

s

choo

s

e to turn on the di

s

play function on computer, it would probably take

s

everal

s

econd

s

for the data to appear on the computer

s

creen

d

Data

s

torage

s

etting

Thi

s

in

s

trument ha

s

the ability to

s

tore 24 hour

s

worth of data. It can

s

tore the mea

s

ured pul

s

e rate

9

and SpO2 value accurately, tran

s

fer the data to the computer, di

s

play the data and print report

s

(with

the included SpO2 Software - Green Heart)

a. From the “Setting

s

M

enu” Click the power button to

s

elect “Record”, then Pre

ss

the power

button to enter the

s

tart time of data

s

torage te

s

t (

s

ee Figure 9).

b. Click the power button to move the underline to the time to be

s

et (hour

s

and minute

s

), then

Pre

ss

and hold the power button to adju

s

t the time

s

etting. After

s

etting the time, Click the power

button to move the underline to “Y”, Pre

ss

the power button to exit the “time

s

etting menu”, and

recording will begin. If you move the underline to “n”, and Pre

ss

the power button to quit the “time

s

etting menu”, the recording will not begin and the data

s

tored in memory will not be deleted.

c. If the data

s

torage function i

s

being turned on, when return to the mea

s

uring interface, a red

"REC"

s

ign and a fla

s

hing red dot would appear on

s

creen, which mean

s

the device i

s

in a

s

tate of

s

toring.

d. In the

s

tate of

s

toring, whatever interface the device i

s

on (mea

s

uring interface, menu interface),

the

s

ign "Recording" would appear on the

s

creen in 30

s

econd

s

, then the

s

creen will be automatically

s

hut down. If pre

ss

the button

s

hortly at thi

s

moment, the

s

ign "Recording" would appear on the

s

creen, and then the

s

creen will be automatically

s

hut down again; if pre

ss

the button long , the

device would return to the former interface.

e. If turning on the data

s

torage function, the former data

s

torage will be automatically removed.

f. In the

s

tate of data

s

toring, after the

s

creen i

s

automatically

s

hut down, the pul

s

e

s

ound

indication would be off for

s

aving power.

g. When the

s

torage

s

pace i

s

full, it di

s

play

s

“

M

emory i

s

full” on the

s

creen, and then

s

hut down in

a few

s

econd

s

. But it will

s

till di

s

play “

M

emory i

s

full” by the next time you turn on the device on

the purpo

s

e of warning the u

s

er, if pre

ss

the button again, it will enter the mea

s

uring interface.

Figure 9

e

Uploading the data to the PC after recording

a. Plea

s

e connect the device with computer by the data line which i

s

affiliated with the device,then

double click"SpO2 Review"icon to open"SpO2 Review"program,click the ‘New Se

ss

ion’ Icon in the

s

oftware, enter the patient data and then click ‘ok’. The Software will then di

s

play “device

connected, waiting for data”.

b. At thi

s

time , Pre

ss

the power button to enter the “Setting

s

M

enu” and then Click the power

button to

s

elect “Upload”. Pre

ss

the power button to

s

elect “on” then the data will be tran

s

ferred to

your computer.

c. In the

s

tate of

s

toring, it i

s

not applicable for the u

s

er

s

to upload the

s

tored date to computer.

d. In the

s

tate of uploading, you cannot end it artificially, when the upload of

s

tored data i

s

fini

s

hed,the menu choice bar will move to "Exit"automatically.

f

Exit the main menu

Click the power button to

s

elect “EXIT”, then Pre

ss

the power button to exit the

M

ain

M

enu.

E.

Charge

There are two kind

s

of charging method

s

:

a

Connect the device with computer by data line, then the device

s

hould be under charging

s

tate.

b

Connect the device with power

s

upply by power adaptor, then the device

s

hould be under

charging

s

tate.

10

c

When the device i

s

in the

s

tate of battery charging, the indication light i

s

on, when the battery

capacity i

s

full, the indication light would be off accordingly.

I

f the alarm function i

s

on,the device will provide high-priority alarm

s

ignal when the

battery i

s

in low power

s

tatu

s

.

I

ntermittent alarm will occur and the battery icon turn

s

red in

the

s

tate of fla

s

hing.

High priority indicating that immediate operator re

s

pon

s

e i

s

required.

6.2. Attention for operation

A.

Plea

s

e check the device before u

s

ing, and confirm that it can work normally.

B

.

The finger

s

hould be in a proper po

s

ition (

s

ee the attached illu

s

tration of Figure 3 for reference),

or el

s

e it may re

s

ult in inaccurate mea

s

ure.

C

.

The SpO2

s

en

s

or and photoelectric receiving tube

s

hould be arranged in a way with the

s

ubject’

s

arteriole in a po

s

ition there between.

D

.

The SpO2

s

en

s

or

s

hould not be u

s

ed at a location or limb tied with arterial canal or blood

pre

ss

ure cuff or receiving intravenou

s

injection.

E

.

Do not fix the SpO2

s

en

s

or with adhe

s

ive or el

s

e it may re

s

ult in venou

s

pul

s

ation and inaccurate

mea

s

ure of SpO2 and pul

s

e rate.

F

.

Exce

ss

ive ambient light may affect the mea

s

uring re

s

ult. It include

s

fluore

s

cent lamp, dual ruby

light, infrared heater, direct

s

unlight and etc.

G

.

Strenuou

s

action of the

s

ubject or extreme electro

s

urgical interference may al

s

o affect the

accuracy.

H

.

Te

s

tee can not u

s

e enamel or other makeup.

I

.

Plea

s

e clean and di

s

infect the device after operating according to the U

s

er

M

anual(6.1).

6.3. Clinical re

s

triction

s

A

.

A

s

the mea

s

ure i

s

taken on the ba

s

i

s

of arteriole pul

s

e,

s

ub

s

tantial pul

s

ating blood flow of

s

ubject

i

s

required. For a

s

ubject with weak pul

s

e due to

s

hock, low ambient/body temperature, major

bleeding, or u

s

e of va

s

cular contracting drug, the SpO2 waveform (PLETH) will decrea

s

e. In thi

s

ca

s

e, the mea

s

urement will be more

s

en

s

itive to interference.

B

.

For tho

s

e with a

s

ub

s

tantial amount of

s

taining dilution drug (

s

uch a

s

methylene blue, indigo

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

M

e+Hb) or

thio

s

alicylic hemoglobin, and

s

ome with icteru

s

problem, the SpO2 determination by thi

s

monitor

may be inaccurate.

C

.

The drug

s

like dopamine, procaine, prilocaine, lidocaine and butacaine may al

s

o be a major

factor blamed for

s

eriou

s

error of SpO2 mea

s

ure.

D

.

A

s

the SpO2 value

s

erve

s

a

s

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

s

ome patient

s

with

s

eriou

s

anemia may al

s

o report good SpO2 mea

s

urement.

11

7. Maintain tran

s

portation and

s

torage

7.1. Cleaning and di

s

infecting

When u

s

ing alcohol wipe

s

to di

s

infect the device, plea

s

e air dry or clean it with clean

s

oft cloth.

7.2. Maintain

A.

Plea

s

e clean and di

s

infect the device before u

s

ing according to the U

s

er

M

anual(7.1).

B.

Plea

s

e recharge the battery when the

s

creen

s

how

s

.

C. Recharge the battery

s

oon after the over-di

s

charge. The device

s

hould be recharged every

s

ix

month

s

when it i

s

no regular u

s

ed. It can extend the battery life following thi

s

guidance.

D.

The device need

s

to be calibrated once a year (or according to the calibrating program of ho

s

pital).

It al

s

o can be performed at the

s

tate-appointed agent or ju

s

t contact u

s

for calibration.

7.3. Tran

s

portation and

s

torage

A.

The packed device can be tran

s

ported by ordinary conveyance or according to tran

s

port contract.

The device can not be tran

s

ported mixed with toxic, harmful, corro

s

ive material .

B.

The be

s

t

s

torage environment of the device i

s

-40ºC~60ºC ambient temperature and not higher

than 95% relative humidity.

8. Trouble

s

hooting

Trouble Po

ss

ible Rea

s

on Solution

The SpO2 and Pul

s

e

Rate can not be

di

s

played normally

1. The finger i

s

not properly po

s

itioned.

2. The patient’

s

SpO2 i

s

too low to be

detected.

1. Place the finger properly and

try again.

2. Try again; Go to a ho

s

pital for

a diagno

s

i

s

if you are

s

ure the

device work

s

all right.

The SpO2 and Pul

s

e

Rate are not

di

s

played

s

tably

1. The finger i

s

not placed in

s

ide deep

enough.

2. The finger i

s

haking or the patient i

s

moving.

1. Place the finger properly and

try again.

2. Let the patient keep calm

The device can not

be turned on

1.

The batterie

s

are drained or almo

s

t

2.

drained.

2. The device’

s

malfunction

1.Plea

s

e recharge the battery

2. Plea

s

e contact the local

s

ervice center.

The di

s

play i

s

off

s

uddenly

1. Thi

s

device i

s

et to be automatically

power off within 5

s

econd

s

when it cannot

detect any

s

ignal

1.Normal

2.Plea

s

e recharge the battery

12

2. The battery i

s

drained away or almo

s

t

drained away .

The battery can not

be full charged even

after 10 hour

s

charging time.

The battery i

s

broken Plea

s

e contact the local

s

ervice

center.

9. Key of Symbol

s

Signal De

s

cription

Warning – See U

s

er

M

anual

%SpO2 The pul

s

e oxygen

s

aturation(%)

bpm Pul

s

e rate (bpm)

Full-voltage

Low-voltage

Clo

s

e the alarm

s

ound indication

Pau

s

e the alarm

s

ound indication

Open the alarm

s

ound indication

Clo

s

e the pul

s

e

s

ound indication

Open the pul

s

e

s

ound indication

menu button/power button/function button

Type BF

USB

SN Serial number

1. the finger clip fall

s

off ( no finger in

s

erted)]

2. Probe error

3. Signal inadequacy indicator

13

IPX1 Ingre

ss

of liquid

s

rank

WEEE (2002/96/EC)

Thi

s

item i

s

compliant with

M

edical Device Directive 93/42/EEC of

J

une

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

10. Function Specification

I

nformation Di

s

play Mode

The Pul

s

e Oxygen Saturation %SpO2 2-digit digital OLED di

s

play

Pul

s

e Rate bpm 3-digit digital OLED di

s

play

Pul

s

e Inten

s

ity (bar-graph) bar-graph OLED di

s

play

SpO2 Parameter Specification

M

ea

s

uring range 0% 100%, (the re

s

olution i

s

1%).

Accuracy 70% 100% ±2% ,Below 70% un

s

pecified.

Average value

Calculate the Average value in every 4 mea

s

ure value.

The deviation between average value and true value doe

s

not exceed 1%.

Pul

s

e Parameter Specification

M

ea

s

uring range 30bpm 250bpm, (the re

s

olution i

s

1bpm)

Accuracy ± 2bpm or ± 2% (

s

elect larger)

Average pul

s

e rate

M

oving calculate the Average pul

s

e rate every 4

cardio-beat,

s

cycle.

The deviation between average value and true value doe

s

not exceed 1%

Safety Type Interior Battery,BF Type

Pul

s

e

I

nten

s

ity

Range Continuou

s

bar-graph di

s

play, the higher di

s

play indicate

the

s

tronger pul

s

e.

Battery Requirement

Voltage 3.7 rechargeable lithium battery × 1

14

Battery working life

Charge and di

s

charge no le

ss

than 500 time

s

.

Power Adapter

Input Voltage

100 to 240 VAC, 50/60 Hz

Output voltage

5 VDC

Output current 10000mA

Oximeter Probe

Wavelength:660nm 880nm

Dimen

s

ion

s

and Weight

Dimen

s

ion

s

57(L) × 32(W) × 30 (H) mm

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

15

Appendix 1

State

Alarm condition delay

Alarm

s

ignal generation delay

Low voltage alarm

60

s

5m

s

SpO2 alarm 1

s

5m

s

Pul

s

e rate alarm 1

s

5m

s

Probe error alarm 16m

s

5m

s

Appendix 2

Guidance and manufacture'

s

declaration

Guidance

and

m

anufactu

r

e’s

decla

r

ation

–

elect

r

o

m

agnetic

e

m

issions-

fo

r

all

EQUIPMENT

and

SYSTEMS

Guidance

and

m

anufactu

r

e’s

decla

r

ation

–

elect

r

o

m

agnetic

e

m

ission

The

PO300

Pulse

Oximeter

is

intended

for

use

in

the

electromagnetic

environment

specified

below.

The

customer

of

the

user

of

the

PO300

Pulse

Oximeter

should

assure

that

it

is

used

in

such

and

environment.

E

m

ission

test

Co

m

pliance

Elect

r

o

m

agnetic

envi

r

on

m

ent

–

guidance

RF

emissions

CISPR

11

Group

1

The

PO300

Pulse

Oximeter

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

emission

CISPR

11

Class

B

The

PO300

Pulse

Oximeter

is

suitable

for

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/

flicker

emissions

IEC

61000-3-3

Not

applicable

16

Guidance and manufacture’

s

declaration – electromagnetic immunity –

for all EQU

I

PMENT and SYSTEMS

Guidance and manufacture’

s

declaration – electromagnetic immunity

The PO300 Pul

s

e Oximete

r

i

s

intended for u

s

e in the electromagnetic environment

s

pecified

below. The cu

s

tomer or the u

s

er of

PO300 Pul

s

e Oximete

r

s

hould a

ss

ure that it i

s

u

s

ed in

s

uch an environment.

I

mmunity te

s

t

I

EC 60601 te

s

t level Compliance level

Electromagnetic

environment - guidance

Electro

s

tatic di

s

charge

(ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±6 kV air

Floor

s

hould be wood,

concrete or ceramic tile. If

floor are covered with

s

ynthetic material, the

relative humidity

s

hould be

at lea

s

t 30%. The

manufacturer may

recommend

the ESD

precautionary procedure

s

to

u

s

er.

Po

wer frequency

(50/60Hz) magnetic field

IEC 61000-4-8

3A/m 3A/m

Power frequency magnetic

field

s

hould be at level

s

characteri

s

tic of a typical

location in a typical

commercial or ho

s

pital

environment.

17

Guidance and manufacture’

s

declaration – electromagnetic immunity –

for EQU

I

PMENT and SYSTEMS that are not L

I

FE-SUPPORT

I

NG

Guidance and manufacture’

s

declaration – electromagnetic immunity

The PO300 Pul

s

e Oximete

r

i

s

intended for u

s

e in the electromagnetic environment

s

pecified below. The cu

s

tomer or the u

s

er of PO300

Pul

s

e Oximete

r

s

hould a

ss

ure that it i

s

u

s

ed in

s

uch an environment.

I

mmunity te

s

t

I

EC 60601 te

s

t level Compliance

level Electromagnetic environment - guidance

Radiated RF

IEC 61000-4-3

3 V/m

80

M

Hz to 2.5 GHz

3 V/m

Portable and mobile RF communication

s

equipment

s

hould be u

s

ed no clo

s

er to any part of

the PO300 Pul

s

e Oximete

r

, including cable

s

, than

the recommended

s

eparation di

s

tance calculated

from the equation applicable to the frequency of

the tran

s

mitter.

Recommended

s

eparation di

s

tance

P

E

d=

1

5.3

80

M

Hz to 800

M

Hz

P

E

d=

1

7

800

M

Hz to 2.5 GHz

Where P

i

s

the maximum output power rating of

the tran

s

mitter in watt

s

(W) according to the

tran

s

mitter manufacturer and d i

s

the recommended

s

eparation di

s

tance in metre

s

(m).

Field

s

trength

s

from fixed RF tran

s

mitter

s

, a

s

determined by an electromagnetic

s

ite

s

urvey,a

s

hould be le

ss

than the compliance level in each

frequency range.b

Interference may occur in the vicinity of equipment

marked with the following

s

ymbol:

NOTE 1 At 80

M

Hz and 800

M

Hz, the higher frequency range applie

s

.

NOTE 2

The

s

e guideline

s

may not apply in all

s

ituation

s

. Electromagnetic propagation i

s

affected by ab

s

orption and reflection

from

s

tructure

s

, object

s

and people.

a

Field

s

trength

s

from fixed tran

s

mitter

s

,

s

uch a

s

ba

s

e

s

tation

s

for radio (cellular/cordle

ss

) telephone

s

and land mobile radio

s

,

amateur radio, A

M

and F

M

radio broadca

s

t and TV broadca

s

t cannot be predicted theoretically with accuracy. To a

ss

e

ss

the

electromagnetic environment due to fixed RF tran

s

mitter

s

, an electromagnetic

s

ite

s

urvey

s

hould be con

s

idered. If the mea

s

ured

field

s

trength in the location in which the PO300 Pul

s

e Oximete

r

i

s

u

s

ed exceed

s

the applicable RF compliance level above, the

PO300 Pul

s

e Oximete

r

s

hould be ob

s

erved to verify normal operation. If abnormal performance i

s

ob

s

erved, additional mea

s

ure

s

may be nece

ss

ary,

s

uch a

s

reorienting or relocating the PO300 Pul

s

e Oximete

r

.

18

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MedToolz PO300 Instructions To User

MedToolz PO300 Instructions To User

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