Rossmax SB220 Manual de Usario

Rossmax Monitor de frecuencia cardíaca SB220

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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 CorrectionsCheck points

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

SpO2

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 (41 ~ 104°C~40°C °F °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 ~ 158°C~+70°C(-13°F °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. 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 Electromagnetic environment-guidanceCompliance

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

Introduction

Rossmax Fingertip Pulse Oximeter SB220 is used

to measure arterial oxygen saturation (% SpO2) of

hemoglobin and pulse rate, an important indicator

of your respiratory function. It is non-invasive device

intended for spot-check of adult and pediatric whose

age is over 3 at home, hospital and clinics.

Attention: Consult the accompanying

documents. Please read this manual carefully

before use. Please be sure to keep this manual.

Installing Batteries

Error code for your reference

1. Use thumb to slide battery cover

out.

2. Insert or replace 2 “AAA” sized

batteries down with the correct

electrical polarity.

You need to replace the batteries

when:

1. Low battery icon appears on

display

2. The function button is pressed

and nothing appears on display.

Caution:

Batteries may leak or explode if

used or disposed of improperly. Remove batteries if the

device will be stored for long time. Do not use different

types or brands of batteries at the same time. Do not

mix fully charged and partially charged batteries at the

same time. The device will automatically shut down in

low battery.

SENSOR ERROR:

Sensor cannot be detected,

return the device to your

local distributor or service

centre.

MEASURE ERROR:

Signals cannot be detected,

turn the device off and meas-

ure again.

Attaching the lanyard

1. Insert the narrow end of the

lanyard through the holder.

2. Draw the other end of the

lanyard through the loop

at the narrow end and

tighten.

How to use

1. Open the clip; press the Power On/Off button as .

2. Information of software version appears. Insert one

finger(left hand middle finger is recommended), nail

side up, into the finger opening of the pulse oximeter

as .

Note: If no finger insert, the device will auto shut off

after 8 seconds.

3. The display shows , pulse oximeter begins its

measurement.

Note: Make sure the finger is lying flat. Do not shake

and keep body steady during measurement.

4. Your SpO2 and pulse rate values will appear on the

screen after few seconds as .

Note: 1. Don’t remove your finger until the measurement

is completed.

2. While pulse strength is low, the reading will

flicker.

Cautionary Notes

- This device is to be operated by trained personnel only.

- The device has intended only for spot-checking, but not

medical result evaluation.

- This device is designed to determine the percentage of ar-

terial oxygen saturation of functional hemoglobin. Factors

that may degrade pulse oximeter performance or aect

the accuracy of the measurement include the following:

• Do not apply the pulse oximeter on the same arm as a

blood pressure cu, arterial catheter or infusion line(s).

• Excessive light, such as sunlight or direct home lighting.

• Not steady at the site of application (e.g. trembling).

• Moisture in the device.

• Improperly applied device.

• Finger is too large or too small to t into the device.

• Poor pulse quality.

• Venous pulsations.

• Anemia or low hemoglobin concentrations.

• Cardiogreen and other intravascular dyes.

• Carboxyhemoglobin.

• Methemoglobin.

• Dysfunctional hemoglobin.

• Articial nails or ngernail polish.

• On ngers with anatomical changes, oedemas, scars

or burns.

- Using the device for long periods may cause pain for

people with circulatory disorders. Reposition the device

at least once every 4 hours to allow the patient’s skin to

breath and to check patient’s condition regularly.

- Do not use the device near ammable or explosive gas

mixtures.

- Do not use the device during an MRI or CT scan, be used

no closer than 30 cm (12 inches) to any part of the SpO2

device, including cables specied by the manufacturer.

- The device may not work when circulation is reduced.

Warm or rub the nger, or re-position the device.

- This device is a precision electronic instrument and must

be repaired by qualied technical professionals. Field re-

pair of the device is not possible. Do no attempt to open

the case or repair the electronics. Opening the case may

damage the device and void the warranty.

- Do not overextend the device’s spring.

- A functional tester cannot be used to access the accu-

racy 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 medica-

tion without prior approval.

- Do not look directly inside the housing during the meas-

urement. 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 (includ-

ing children) with restricted physical, sensory or mental

skills or a lack of experience and/or a lack of knowledge,

unless they are supervised by a person who has respon-

sibility for their safety or they receive instructions from

this person 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 ex-

clusively used to display the current signal variation at

the measurement site and do not enable reliable diag-

nostics for the pulse.

- The maximum temperature of sensors which the user

will touch might reach 43°C when operating in the 40°C

environment.

- The safety for user use in high-temperature environment

is measuring for 10 minutes, and turn it o for 20 min-

utes before measure again.

5. Press button shortly to reverse the display upside

down.

Note:

1. The SpO2 sensor and photoelectric receiving tube

should be arranged in a way with the subject’s arteriole

in a position there between.

2. Make sure the optical path is free from any optical

obstacles like rubberized fabric.

3. Excessive ambient light may affect the measuring

result. It includes fluorescent lamp, dual ruby light,

infrared heater, direct sunlight and etc.

4. Strenuous action of the subject or extreme

electrosurgical interference may also affect the

accuracy.

5. The device has a visual and audio signal when the

measurement of SpO 2 is lower than 90%.

Name/ Functions of each part

1. OLED display

2. Pulse strength

3. Pulse search icon

4. Remind icon

5. Battery indicator

6. Power On/O Button

7. Battery compartment

8. Pulse rate icon

9. SpO2 icon





Especificaciones del producto

Marca:	Rossmax
Categoría:	Monitor de frecuencia cardíaca
Modelo:	SB220

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