Mode d’emploi Rossmax SB100 Oxymètre de pouls

Mode d’emploi

Cleaning and disinfection

Troubleshooting

Specification

1. Please clean the surface of the device before

using. Wipe the device with medical alcohol

(70% isopropyl alcohol)first, and then let it dry

in air or clean it by dry clean fabric. When clean-

ing the device with water, the water tempera-

ture should be lower than 60ºC

2. Using the medical alcohol to disinfect the prod-

uct after use, prevent from cross infection for

next time use.

3. The best storage environment of the device

is - 20ºC to 70ºC ambient temperature and not

higher than 95% relative humidity.

4. Users are advised to calibrate the device termly

(or according to the calibrating program of

hospital). It also can be performed at the state-

appointed agent or just contact us for calibra-

tion.

Symptoms Check points Corrections

SpO2 or

pulse rate

cannot

displayed

Applied nger

improperly.

Place the nger

properly and try

again.

SpO2 is too low to

detect

Try again; go to

consult with your

physician if you

are sure the de-

vice works well.

SpO2 or

pulse rate

are not

displayed

stably

Applied nger

improperly.

Place the nger

properly and try

again.

Finger is shaking or

body is moving.

keep body

steady

No display

when

button is

pressed

Batteries run down

Replace with

new batteries

Batteries not in-

serted correctly.

Re-insert bat-

teries

The display

disappears

suddenly

The device will

auto power o

when it gets no

signal.

Normal

Low battery

Replace with

new batteries

Note: If the unit does not work, return it to

your dealer. Under no circumstance

should you disassemble and repair the

unit by yourself.

SpO2

Measuring range 35%~99%, (the resolution is 1%).

Accuracy 70%~99%: ±2%, Below 35~69%:

unspecied.

Optical Sensor Red light (wavelength is 660nm),

Infrared (wavelength is 905/880nm)

Pulse

Measuring range 30bpm~250bpm (the resolution is

1 bpm)

Accuracy ±3bpm

Power source AAA × 2 (Alkaline)

Battery life Continually for 16 hours with two

alkaline batteries

Operating

Condition

Temperature: 5ºC~40ºC (41ºF ~

104ºF), Relative Humidity: 15-95%

(non condensing), Atmospheric

pressure: 700hPa ~ 1013hkPa,

Attitude: -1,280 to 12,000 feet

(-390m to 3,658m)

Storage

Condition

Temperature: -25ºC~+70ºC(-

13ºF ~ 158ºF), Relative humidity:

15-90%(non condensing),

Atmospheric pressure: 700hPa ~

1013hkPa, Attitude: -1,280 to 12,000

feet (-390m to 3,658m)

Dimensions 63.5(L) × 34W) × 35(H) mm

Weight About 37g (without the batteries)

Standards IEC60601-1-2, Class B, IEC60601-1,

Type BF, ISO80601-2-61

Type BF applied parts

IP Classication IP22: Protection against harmful

ingress of water and particulate

matter

Note: 1. Do not sterilize, autoclave or immerse this

device in liquid. Do not pour or spray any

liquids onto the device.

2. Do not use caustic or abrasive cleaning

agents, or any cleaning agent containing

ammonium chloride or isopropyl alcohol.

- A functional tester cannot be used to access the

accuracy of a pulse oximeter monitor.

- Do not self-diagnose or self-medicate on the

basis of the measurements without consulting

your doctor. In particular, do not start taking

any new medication or change the type and/or

dosage of any existing medication without prior

approval.

- Do not look directly inside the housing during

the measurement. The red light and the invisible

infra-red light in the pulse oximeter are harmful

to your eyes.

- This device is not intended for use by people

(including children) with restricted physical, sen-

sory or mental skills or a lack of experience and/

or a lack of knowledge, unless they are super-

vised by a person who has responsibility for their

safety or they receive instructions from this per-

son on how to use the device. Children should

be supervised around the device to ensure they

do not play with it.

- Neither of the displays for the pulse wave and

pulse bar allows the strength of the pulse or

circulation to be evaluated at the measurement

site. Rather, they are exclusively used to display

the current signal variation at the measurement

site and do not enable reliable diagnostics for

the pulse.

Model: SB100

www.rossmax.com

Fingertip Pulse Oximeter

IN0SB1000000000XX

RI_IB_SB100_EN_SW_ver1708

Warranty Card

This instrument is covered by a 1 year guarantee from the date of purchase, batteries

and accessories are not included. The guarantee is valid only on presentation of the

guarantee card completed by the dealer confirming date of purchase or the receipt.

Opening or altering the instrument invalidates the guarantee. The guarantee does

not cover damage, accidents or non-compliance with the instruction manual. Please

contact your local seller/dealer or www.rossmax.com.

Customer Name: __________________________________

Address: _______________________________________

Telephone: _____________________________________

E-mail address: ___________________________________

Gender:

Male Female Age: _____

Product Information: ______________________________

Date of purchase: _________________________________

Store where purchased: _____________________________

Rossmax InnoTek Corp.

12F., No. 189, Kang Chien Rd., Taipei, 114, Taiwan.

Rossmax Swiss GmbH,

Tramstrasse 16, CH-9442 Berneck, Switzerland

WARNING: The symbol on this product means that it's an electronic product

and following the European directive 2012/19/EU the electronic products have

to be dispose on your local recycling centre for safe treatment.

EMC guidance and manufacturer’s declaration

Recommended separation distances between portable and mobile RF communications equipment and the ME equipment

The Finger-tip pulse oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of the Finger-tip pulse oximeter can help prevent electromagnetic interference by main-

taining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Finger-tip

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 , d=[3.5/

V1]√P

80 MHz to 800 MHz , d=[3.5/

E1]√P

800 MHz to 2,5 GHz , d=[3.5/

E1]√P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.7 3.7 7.37

100 11.67 11.67 23.33

Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING and

are specied for use only in a shielded location

The Finger-tip pulse oximeter declaration – electromagnetic immunity

The Finger-tip pulse oximeter system is intended for use in the electromagnetic environment specied below. The customer

or the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3V

Portable and mobile RF communications equipment should be used

no closer to any part of the EQUIPMENT or SYSTEM including cables,

than the recommended separation distance calculated from the

equation applicable to the frequency of the transmitter. Interference

may occur in the vicinity of equipment marked with the following

symbol.

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3V/m

Declaration – electromagnetic immunity

The Finger-tip pulse oximeter system is intended for use in the electromagnetic environment specied below. The customer

or the user of the Finger-tip pulse oximeter system 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

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic

tile. If oors are covered with synthetic

material, the relative humidity should be

at least 30 %.

Electrical fast

transient/burst IEC

61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines Mains power quality should be that

of a typical commercial or hospital

environment.

Surge IEC

61000-4-5

± 1kV dierential mode

± 2kV common mode

± 1kV dierential mode

± 2kV common mode

Mains power quality should be that

of a typical commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines IEC

61000-4-11

<5% UT(>95% dip in UT)

for 0,5 cycle

40% UT(60% dip in UT)

for 5 cycles

70% UT(30% dip in UT) for

25 cycles

<5% UT(>95% dip in

UT) for 5 s

<5% UT(>95% dip in UT)

for 0,5 cycle

40% UT(60% dip in UT)

for 5 cycles

70% UT(30% dip in UT) for

25 cycles

<5% UT(>95% dip in

UT) for 5 s

Mains power quality should be that of a

typical commercial or hospital environ-

ment. If the user of the EQUIPMENT or

SYSTEM requires continued operation

during power mains interruptions, it is

recommended that the EQUIPMENT or

SYSTEM be powered from an uninterrupt-

ible power supply or a battery.

Power frequency

(50/60 Hz) mag-

netic eld IEC

61000-4-8

3 A/m 3 A/m Power frequency magnetic elds should

be at levels characteristic of a typical

location in a typical commercial or hospital

environment.

Declaration – electromagnetic emissions

The Finger-tip pulse oximeter is intended for use in the electromagnetic environment specied below. The customer or the user

of the Finger-tip pulse oximeter should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment-guidance

CE emissions CISPR11 Group 1 The Finger-tip pulse oximeter uses RF energy only for its internal func-

tion. Therefore, its RF emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B The Finger-tip 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 Class A

Voltage uctuations/icker emissions

IEC 61000-3-3

Complies

Évaluation

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