User's Manual

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C. Please replace the batteries in time when low-battery appears.

D.Please take out the batteries if the device is not used for a long time.

E. The device need not to be calibrated during maintenance.

6.3 Transport and Storage

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

transport contract. During transportation, avoid strong shock, vibration and splashing

with rain or snow, and it can not be transported mixed with toxic, harmful, corrosive

material.

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

ventilation. Temperature: -40°C~+60°C; Relative humidity: ≤95%.

7 Troubleshooting

Trouble

Possible Reason

Solution

The SpO

and

Pulse Rate

can not be

displayed

normally

1) The finger is not properly

inserted.

2) The finger is shaking or the

patient is moving.

3) The device is not used in

environment required by the

manual.

4) The device works

abnormally.

1) Please insert the finger

properly and measure

again.

2) Let the patient keep

calm.

3) Please use the device in

normal environment.

4) Please contact the

after-sales.

The SpO

and

Pulse Rate are

not displayed

stably

1) The finger is not placed

inside deep enough.

2) The finger is shaking or the

patient is moving.

1) Place the finger properly

and try again.

2) Let the patient keep calm

The device

can not be

turned on

1) The battery is drained away

or almost drained away.

2) The battery is installed

incorrectly.

3) The device’s malfunction.

1) Please change batteries.

2) Please Install the battery

again.

3) Please contact the local

service center.

The display is

off suddenly

1) The device enters into the

energy saving mode.

2) Low battery.

3) The device works

abnormally.

1) Normal.

2) Please charge the

battery.

3) Please contact the

after-sales.

8 Key of Symbols

Symbol

Description

Type BF

Refer to instruction manual/booklet

%SpO

The pulse oxygen saturation(%)

PRbpm

Pulse rate (bpm)

The battery voltage indication is deficient

(change the battery in time avoiding the inexact measure)

1. No finger inserted

2. An indicator of signal inadequacy

Battery positive electrode

Battery cathode

Exit standby mode

Serial number

Alarm inhibit

WEEE (2002/96/EC)

IP22

Ingress of liquids rank

Storage and Transport Temperature limitation

Storage and Transport Humidity limitation

Storage and Transport Atmospheric pressure limitation

This side up

Fragile, handle with care

Keep dry

Recyclable

European Representative

This item is compliant with Directive 93/42/EEC of 14 june

1993 concerning medical devices; Including, at 21 march

2010, the amendments by Council Directive 2007/47/EEC.

Note：Your device may not contain all the following symbols.

9 Function Specification

SpO

[see note 1]

Display range

0% ~ 99%

Measured range

0% ~ 100%

Accuracy

[see note 2]

70%~100%: ±2%;

0%~69%: unspecified.

Resolution

Display range

30 bpm ~ 250 bpm

Measured range

30 bpm ~ 250 bpm

Accuracy

±2 bpm or ±2%, whichever is greater.

Resolution

1 bpm

Accuracy under

low perfusion

[see note 3]

Low perfusion 0.4%:

SpO

: ±4%;

PR: ±2 bpm or ±2%, whichever is greater

Light interference

Under normal and ambient light conditions, the SpO

deviation ≤ 1%

Optical sensor [see note 4]

Red light

Wavelength: about 660 nm, optical output power: < 6.65 mW

Infrared light

Wavelength: about 905 nm, optical output power: < 6.75 mW

Safety class

Internally powered equipment, type BF applied part

International

Protection

IP22

Working voltage

DC 2.6 V ~ 3.6 V

Working current

≤ 25 mA

Power supply

1.5V (AAA size) alkaline batteries × 2 or rechargeable battery

Battery life

Two batteries can work continually for 24 hours

Dimension and Weight

Dimension

57 mm(L) × 31 mm(W) × 32 mm(H)

Weight

About 50 g (including a lithium battery)

Note 1: the claims of SpO

accuracy shall be supported by clinical study measurements

taken over the full range. By artificial inducing, get the stable oxygen level to the range

of 70 % to 100 % SpO

, compare the SpO

values collected by the secondary standard

pulse oximeter equipment and the tested equipment at the same time, to form paired

data, which are used for the accuracy analysis.

There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; skin color: black: 2, light: 8,

white: 2) data in the clinical report.

Note 2: because pulse oximeter equipment measurements are statistically distributed,

only about two-thirds of pulse oximeter equipment measurements can be expected to

fall within ±Arms of the value measured by a CO-OXIMETER.

Note 3: percentage modulation of infrared signal as the indication of pulsating signal

strength, patient simulator has been used to verify its accuracy under conditions of low

perfusion. SpO

and PR values are different due to low signal conditions, compare them

with the known SpO

and PR values of input signal.

Note 4: optical sensors as the light-emitting components, will affect other medical

devices applied the wavelength range. The information may be useful for the clinicians

who carry out the optical treatment.For example, photodynamic therapy operated by

clinician.

Note 5: Patient simulator has been used to verify the pulse rate accuracy, it is stated as

the root-mean-square difference between the PR measurement value and the value set

by simulator.

EMC

Note:

 The device is subject to special EMC precautions and it must be installed and used in

accordance with these guidelines.

 The electromagnetic field can affect the device performance, so other equipment used

near the device must meet the corresponding EMC requirements. Mobile phones,

X-rays or MRI devices are possible interference source, as they can emit high-intensity

electromagnetic radiation.

 Refer to above chapters for the minimum value of user’s physiological signal.

Inaccurate result will appear when the device operates with the values lower than the

descriptions in above chapter

 The use of ACCESSORIES, transducers and cables other than those specified, with the

exception of transducers and cables sold by the MANUFACTURER of the ME

EQUIPMENT or ME SYSTEM as replacement parts for internal components, may

result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or

ME SYSTEM.

 The device should not be used adjacent to or stacked with other equipment and that if

adjacent or stacked use is necessary, it should be observed to verify normal operation in

the configuration in which it will be used.

 Devices or systems may still be interfered by other equipment, even if other equipment

meets the requirements of the corresponding national standard.

 Basic performance: SpO

measured range: 70% ~ 100%, absolute error: ±2%; PR

measured range: 30 bpm ~ 250 bpm, accuracy: ±2 bpm or ±2%, whichever is greater.

Appendix 1

Guidance and manufacture's declaration

Guidance and manufacture’s declaration – electromagnetic emissions-

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic emission

The Pulse Oximeter is intended for use in the electromagnetic environment specified below.

The customer of the user of the Pulse Oximeter should assure that it is used in such and

environment.

Emission test

Compliance

Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1

The 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 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.

Guidance and manufacture’s declaration – electromagnetic immunity –

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specified below.

The customer or the user of Pulse Oximeter should assure that it is used in such an

environment.

Immunity

test

IEC 60601

test level

Compliance

level

Electromagnetic environment -

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

8 kV contact

15 kV air

8 kV contact

15 kV air

Floors should be wood, concrete or

ceramic tile. If floor are covered

with synthetic material, the relative

humidity should be at least 30%. the

manufacturer may recommend the

ESD precautionary procedures to

user.

Power frequency

(50Hz) magnetic

field

IEC 61000-4-8

30A/m

Power frequency magnetic fields

should be at levels characteristic of

a typical location in a typical

commercial or hospital

environment.

Guidance and manufacture’s declaration – electromagnetic immunity –

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration – electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specified

below. The customer or the user of Pulse Oximeter should assure that it is used in such an

environment.

Immunity

test

IEC 60601

test level

Complianc

e level

Electromagnetic environment - guidance

Conducted

IEC

61000-4-6

Radiated

IEC

61000-4-3

3V(0.15MH

z–80MHz),

6V(in ISM

bands

between

0.15MHz

and

80MHz)

10 V/m

80 MHz to

2.7GH

3V(0.15M

Hz–80MHz

),6V(in

ISM bands

between

0.15MHz

and

80MHz)

10 V/m

Portable and mobile RF communications

equipment should be used no closer to any

part of the Pulse Oximeter, including cables,

than the recommended separation distance

calculated from the equation applicable to the

frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2.7 GHz

Where P is the maximum output power rating

of the transmitter in watts (W) according to

the transmitter manufacturer and d is the

recommended separation distance in metres

(m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site

survey,a should be less than the compliance

level in each frequency range.b

Interference may occur in the vicinity of

equipment marked with the following

symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV

broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic

environment due to fixed RF transmitters, an electromagnetic site survey should be

considered. If the measured field strength in the location in which the Pulse Oximeter is

used exceeds the applicable RF compliance level above, the Pulse Oximeter should be

observed to verify normal operation. If abnormal performance is observed, additional

measures may be necessary, such as reorienting or relocating the Pulse Oximeter.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3

V/m.

Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM –

for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances between

portable and mobile RF communications equipment and the Pulse Oximeter.

The Pulse Oximeter is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter

can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF communications equipment (transmitters) and the Pulse

Oximeter as recommended below, according to the maximum output power of the

communications equipment.

Rated

maximum

output

power of

transmitter

(W)

Separation distance according to frequency of transmitter(m)

150 kHz to 80 MHz















5.3

80 MHz to 800 MHz















5.3

800 MHz to 2.7 GHz















0.01

0.058

0.035

0.07

0.1

0.18

0.11

0.22

0.58

0.35

0.7

1.83

1.10

2.21

100

5.8

3.5

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in metres (m) can be estimated using the equation applicable to the

frequency of the transmitter, where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency

range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reflection from structures, objects and people.















5.3















5.3













