Manual Rossmax SB220 Pulse Oximeter

Manual

Cleaning

Maintenance

Troubleshooting

Specification

1. Please clean the surface of the device before using.

Wipe the device with medical alcohol (70% isopro-

pyl alcohol)first, and then let it dry in air or clean it

by dry clean fabric. When cleaning the device with

water, the water temperature should be lower than

60°C

2. Using the medical alcohol to disinfect the product

after use, prevent from cross infection for next time

use.

3. The best storage environment of the device is - 25°C

to 70°C ambient temperature and not higher than

90% relative humidity.

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.

Recommends user to return this device to the man-

ufacturer perform the following checks every 24

months.

- Inspect the equipment for mechanical and functional

damage or deterioration.

- Ensure all user interface keys and accessories function

normally.

Note: Manufacturer use Index2 SpO2 simulator to ver-

ify operation of the pulse oximeter equipment.

Symptoms Check points Corrections

SpO2 or pulse

rate cannot

displayed

Applied nger

improperly.

Place the nger prop-

erly and try again.

SpO2 is too low to

detect

Try again; go to consult

with your physician if

you are sure the device

works well.

SpO2 or pulse

rate are not dis-

played stably

Applied nger

improperly.

Place the nger prop-

erly 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

inserted correctly.

Re-insert batteries

The display

disappears

suddenly

The device will auto

power o when it

gets no signal.

Normal

Low battery

Replace with new

batteries

SpO

2

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

Accuracy 70%~99%: ±2%, Below 35~69%: unspecied

Optical Sensor The wavelength of red LED is 660 nm and

Infrared LED is 905/880 nm with maximum

optical output power of 4 mW/sr.

Pulse

Measuring range 30 bpm~250 bpm (the resolution is 1 bpm)

Accuracy ±3 bpm

Power source AAA × 2 (Alkaline)

Battery life Continually for 16 hours with two alkaline

batteries

Operating

Condition

Temperature: 5°C~40°C (41°F ~ 104°F),

Relative Humidity: 15-95% (non condensing),

Atmospheric pressure: 700hPa ~ 1060hPa,

Attitude: -1,280 to 12,000 feet (-390m to 3,658m)

Storage /

Transportation

Condition

Temperature: -25°C~+70°C(-13°F ~ 158°F),

Relative humidity: 15-90%(non condensing),

Atmospheric pressure: 700hPa ~ 1060hPa,

Attitude: -1,280 to 12,000 feet (-390m to 3,658m)

Dimensions 63.5(L) × 34(W) × 35(H) mm

Weight About 37g (without the batteries)

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

ISO80601-2-61, IEC60601-1-11

Type BF applied parts

IP Classication IP22: Protection against harmful ingress of water

and particulate matter

Attention

Serial number

Manufacturer

Date of manufacture

Authorized representative in the European

Community

Note:

- A description of the effect on displayed and transmitted

SpO2 and pulse rate:

- Data averaging: 4 seconds for SpO2; 8 seconds for pulse

rate.

- Data update delay: Less than 2 seconds.

- The oximeter is calibrated in the factory before sale.

There is no need to calibrate during its life cycle.

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

dealer. Under no circumstance should you

disassemble and repair the unit by yourself.

Model: SB220

www.rossmax.com

Fingertip Pulse Oximeter

Rossmax InnoTek Corp.

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

114, Taiwan.

CMC Medical Devices & Drugs S.L.

C/ Horacio Lengo Nº 18, CP 29006,

Málaga, Spain

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.

IN0SB221000000013

Warranty Card

This instrument is covered by a 2 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: ___________________________________

Product Information: ______________________________

Date of purchase: _________________________________

Store where purchased:

______________________________________________

RI_IB_SB220_EN_

2Yr_TP_ver2128

Note:

1. The product is with a service life of 5 years in the course

of regular use.

2. If any serious incident (e.g. death) has occurred in

relation to the device should be reported to the

dealer, manufacturer, and the competent authority of

the Member State in which the user and/or patient is

established.

3. The text is subject to change without further notice.

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 elec-

tromagnetic interference by maintaining a minimum distance between portable and mobile RF communi-

cations 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 sup-

ply lines

±1 kV for input/

output lines

±2 kV for power sup-

ply 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 interrup-

tions 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 environment. If the user

of the EQUIPMENT or SYSTEM

requires continued operation

during power mains interruptions,

it is recommended that the EQUIP-

MENT or SYSTEM be powered

from an uninterruptible power

supply or a battery.

Power frequency

(50/60 Hz)

magnetic 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 com-

mercial 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 function. 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 emis-

sions IEC 61000-3-3

Complies

Rating

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