background image

Instructions to User

Dear

 

Users,

 

thank

 

you

 

very

 

much

 

for

 

purchasing

 

our

 

product.

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,

 

as

 

well

 

as

 

the

 

safety

 

procedures

 

to

 

protect

 

both

 

the

 

user

 

and

 

equipment.

 

Refer

 

to

 

the

 

respective

 

chapters

 

for

 

details.

Please

 

read

 

the

 

Manual

 

very

 

carefully

 

before

 

using

 

this

 

equipment.

 

These

 

instructions

 

describe

 

the

 

operating

 

procedures

 

to

 

be

 

followed

 

strictly,

 

failure

 

to

 

follow

 

these

 

instructions

 

can

 

cause

 

measuring

 

abnormality,

 

equipment

 

damage

 

and

 

personal

 

injury.

 

The

 

manufacturer

 

is

 

NOT

 

responsible

 

for

 

the

 

safety,

 

reliability

 

and

 

performance

 

issues

 

and

 

any

 

monitoring

 

abnormality,

 

personal

 

injury

 

and

 

equipment

 

damage

 

due

 

to

 

user's

 

negligence

 

of

 

the

 

operation

 

instructions.

 

The

 

manufacturer’s

 

warranty

 

service

 

does

 

not

 

cover

 

such

 

faults.

The

 

specific

 

products

 

you

 

received

 

may

 

not

 

be

 

exactly

 

as

 

described

 

in

 

this

 

User

 

Manual.

 If you have any 

questions regarding to the use of this product, please call us at 888-970-2999 M-F from 8:00 AM to 5:00 PM CST

WARNING:

The

 

uncomfortable

 

or

 

painful

 

feeling

 

may

 

appear

 

if

 

using

 

the

 

device

 

ceaselessly.

 

It

 

is

recommended

 

that

 

the

 

sensor

 

should

 

not

 

be

 

applied

 

to

 

the

 

same

 

finger

 

for

 

over

 

2

 

hours.

For

 

the

 

individual

  user 

there

 

should

 

be

 

a

 

more

 

prudent

 

inspecting

 

in

 

the

 

placing

 

process.

 

The

device

 

can

 

not

 

be

 

clipped

 

on

 

swollen

 

or

 

tender

 

tissue.

The

 

light

 

(the

 

infrared

 

is

 

invisible)

 

emitted

 

from

 

the

 

device

 

is

 

harmful

 

to

 

the

 

eyes,

 

so

 

the

 

user

 

and

 

the

maintenance

 

man,

 

can

 

not

 

stare

 

at

 

the

 

light.

User 

can

 

not

 

use

 

fingernail

 

polish,

 

fake

 

nails

 

or

 

other

 

makeup.

User 

fingernail

can

 

not

 

be

 

too

 

long.

Please

 

peruse

 

the

 

relative

 

content

 

about

 

the

 

clinical

 

restrictions

 

and

 

cautions.

This

 

device

 

is

 

not

 

intended

 

for

 

treatment.

1 Safety

1.1 Instructions for Safe Operations

Check

 

the

 

main

 

unit

 

and

 

all

 

accessories

 

periodically

 

to

 

make

 

sure

 

that

 

there

 

is

 

no

 

visible

 

damage

 

that

 

may

affect

 users 

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

 

monitor.

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

 

leaving

 

factory.

1.2 Warnings

Explosive

 

hazard—DO

 

NOT

 

use

 

the

 

oximeter

 

in

 

environment

 

with

 

flammable

 

gas

 

such

 

as

 

some

 

ignitable

anesthetic

 

agents.

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,

 

foam

 

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.

1.3 Attentions

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

 

for

 

instructions

 

of

 

cleaning

 

and

 

disinfection.

Do

 

not

 

have

 

the

 

oximeter

 

immersed

 

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.

For

 

fingers

 

which

 

are

 

too

 

thin

 

or

 

too

 

cold,

 

improved

 

readings

 

can

 

be

 

achieved

 

by

 

placing

 

on

 

a

 

thick

 

finger

such

 

as

 

thumb

 

and

 

middle

 

finger

 

.

Do

 

not

 

use

 

the

 

device

 

on

 

infant

 

or

 

neonatal

 users.

The

 

product

 

is

 

suitable

 

for

 

children

 

above

 

four

 

years

 

old

 

and

 

adults

 

(Weight

 

should

 

be

 

between

 

15kg/

33lbs

 

to

 

110kg/243lbs).

The

 

device

 

may

 

not

 

work

 

for

 

all

 users. 

If

 

you

 

are

 

unable

 

to

 

achieve

 

stable

 

readings,

 

discontinue

 

use.

The

 

data

 

refresh

 

is

 

less

 

than

 

5

 

seconds.

The

 

waveform

 

is

 

normalized.

 

Please

 

read

 

the

 

measured

 

value

 

when

 

the

 

waveform

 

on

 

screen

 

is

steady-going,

 

this

 

measured

 

value

 

is

 

the

 

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

 

instrument

 

shows

 

the

 

low-voltage

 

indicator

 

when

 

the

 

battery

 

is

 

low

 

requiring

 

a

 

battery

 

replacement.

Batteries

 

must

 

be

 

removed

 

if

 

the

 

device

 

is

 

going

 

to

 

be

 

stored

 

for

 

more

 

than

 

one

 

month,

 

or

 

else

 

batteries

 

may

leak.

A

 

flexible

 

circuit

 

connects

 

the

 

two

 

parts

 

of

 

the

 

device.

 

Do

 

not

 

twist

 

or

 

pull

 

on

 

the

 

connection.

1.4

 

Indication

 

for

 

Use

The Pulse Oximeter is a non-invasive device intended for the spot-check of saturation of arterial 
hemoglobin(SpO2) and the pulse rate of adult in home use environments.This device is not intended for 
continuous monitoring.The device can be multi-used.

 

Solely for use with sporting and aviation activities.

2 Overview

The

 

pulse

 

oxygen

 

saturation

 

is

 

the

 

percentage

 

of

 

HbO

2

 

in

 

the

 

total

 

Hb

 

in

 

the

 

blood,

 

so-called

 

the

 

O

2

 

concentration

 

in

 

the

 

blood.

 

It

 

is

 

an

 

important

 

bio-parameter

 

for

 

respiration.

 

For

 

the

 

purpose

 

of

 

measuring

 

the

 

SpO

2

 

more

 

easily

 

and

 

accurately,

 

our

 

company

 

developed

 

the

 

Pulse

 

Oximeter.

 

At

 

the

 

same

 

time,

 

the

 

device

 

can

 

measure

 

the

 

pulse

 

rate

 

.

The

 

Pulse

 

Oximeter

 

features

 

small

 

size,

 

low

 

power

 

consumption,

 

convenient

 

operation

 

and

 

being

 

portable.

 

It

 

is

 

only

 

necessary

 

for

 users 

to

 

put

 

one

 

finger

 

into

 

the

 

device

 

to

 

quickly

 

get

 

a

 

reading.

2.1

 

Features

Operation of the product is simple and convenient.

The product is small in volume, light in weight (total weight is about 50 g including batteries) and
convenient to carry.

Power consumption of the product is low and the two originally equipped AAA batteries can be operated
continuously for 20 hours.

The product will enter standby mode when no signal is in the product within 5 seconds.

Display direction can be changed automatically,easy to view.

2.2 Major Applications and Scope of Application

The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through finger, and
indicate the pulse intensity by the bar-display.

The

 

product

 

is

 

not

 

suitable

 

for

 

use

 

in

 

continuous

 

monitoring

 

of

 

home users

The

 

problem

 

of

 

overrating

 

would

 

emerge

 

occur

 

when

 

the

 user 

is

 

suffering

 

from

 

toxicities

 

caused

 

by

carbon

 

monoxide,

 

the

 

device

 

is

 

not

 

recommended

 

to

 

be

 

used

 

under

 

this

 

circumstance.

2.3

 

Environment

 

Requirements

Storage

 

Environment

a) Temperature: -40

~+60

b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa

Operating Environment

a) Temperature: 10

~40

b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700hPa~1060hPa

3 Principle and Caution

3.1 Principle of Measurement

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
(HbO

2

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

3.2 Caution

1.

The

 

finger

 

should

 

be

 

placed

 

properly

 

(see

 

the

 

attached

 

illustration

 

of

 

this

 

manual,

 

Figure

 

5),

 

or

 

else

 

it

 

may

 

cause

inaccurate

 

measurement.

2.

The

 

SpO

2

 

sensor

 

and

 

photoelectric

 

receiving

 

tube

 

should

 

be

 

arranged

 

in

 

a

 

way

 

with

 

the

 

subject’s

 

arteriole

 

in

 

a

 

position

 

there

 

between.

3.

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.

4.

Make

 

sure

 

the

 

optical

 

path

 

is

 

free

 

from

 

any

 

optical

 

obstacles

 

like

 

rubberized

 

fabric.

5.

Excessive

 

ambient

 

light

 

may

 

affect

 

the

 

measuring

 

result.

 

It

 

includes

 

fluorescent

 

lamp,

 

dual

 

ruby

 

light,

 

infrared

 

heater,

 

direct

 

sunlight

 

etc.

6.

Strenuous

 

action

 

of

 

the

 

subject

 

or

 

extreme

 

electro

 

interference

 

may

 

also

 

affect

 

the

 

accuracy.

7.

User 

can

 

not

 

use

 

fingernail

 

polish,

 

fake

 

nails

 

or

 

other

 

makeup.

3.3

 

Clinical

 

Restrictions

1.

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.

2.

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

 

monitor

 

may

 

be

 

inaccurate.

3.

The

 

drugs

 

like

 

dopamine,

 

procaine,

 

prilocaine,

 

lidocaine

 

and

 

butacaine

 

may

 

also

 

be

 

a

 

major

 

factor

 

blamed

 

for

serious

 

error

 

of

 

SpO

2

 

measure.

4.

As

 

the

 

SpO

2

 

value

 

serves

 

as

 

a

 

reference

 

value

 

for

 

judgement

 

of

 

anemic

 

anoxia

 

and

 

toxic

 

anoxia,

 

some

 users

with

 

serious

 

anemia

 

may

 

also

 

report

 

good

 

SpO

2

 

measurement.

4 Technical Specifications

1)

Display

 

Format:

 

OLED

 

Display;

SpO

2

 

Measuring

 

Range:

 

0%

 

~

 

100%;

Pulse

 

Rate

 

Measuring

 

Range:

 

30bpm

 

~

 

250

 

bpm;

Pulse

 

Wave

 

Display:

 

columniation

 

display

 

and

 

the

 

waveform

 

display.

PI

 

Measuring

 

Range:

 

0

 

~

 

20

2)

Power

 

Requirements:

 

2×1.5V

 

AAA

 

alkaline

 

battery

 

(or

 

using

 

the

 

rechargeable

 

battery

 

instead),

 

adaptable

range:

 

2.6V~3.6V.

3)

Power

 

Consumption:

 

less

 

than

 

80mA.

4)

Resolution:

 

1%

 

for

 

SpO

2

 

,

 

1

 

bpm

 

for

 

Pulse

 

Rate

 

and

 

0.1%

 

for

 

PI.

5)

Measurement

 

Accuracy:

 

±2%

 

in

 

stage

 

of

 

70%-100%

 

SpO

2

,

 

and

 

meaningless

 

when

 

stage

 

being

 

smaller

 

than

70%.

 

±2

 

bpm

 

during

 

the

 

pulse

 

rate

 

range

 

of

 

30-99

 

bpm

 

and

 

±2%

 

during

 

the

 

pulse

 

rate

 

range

 

of

 

100~250

 

bpm.

6)

Measurement

 

Performance

 

in

 

Weak

 

Filling

 

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

 

during

 

the

 

pulse

 

rate

 

range

 

of

30~99

 

bpm

 

and

 

±2%

 

during

 

the

 

pulse

 

rate

 

range

 

of

 

100~250

 

bpm

 

.

7)

Resistance

 

to

 

surrounding

 

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%.

8)

It

 

is

 

equipped

 

with

 

a

 

function

 

switch.

 

The

 

product

 

will

 

enter

 

standby

 

mode

 

when

 

no

 

signal

 

is

 

in

 

the

 

product

within

 

5

 

seconds.

9)

Optical

 

Sensor

Red

 

light

 

(wavelength

 

is

 

660nm,

 

6.65mW)

Infrared

 

(wavelength

 

is

 

880nm,

 

6.75mW)

wavelength range.

5 Accessories

One lanyard ;

Two batteries,carrying case and rubber boot cover

One User Manual.

6 Installation

6.1 View of the Front Panel

Figure 2 Front view

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