Handleiding Rossmax SB200 (pagina 1 van 2) (Engels)

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- 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 flammable 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 specified by the manufacturer.

- The device may not work when circulation is reduced. Warm or

rub the finger, or re-position the device.

- This device is a precision electronic instrument and must be

repaired by qualified technical professionals. Field repair 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 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, sensory or mental skills or a

lack of experience and/or a lack of knowledge, unless they are

supervised by a person who has responsibility 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 exclusively used to display

the current signal variation at the measurement site and do not

enable reliable diagnostics 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 off for 20 minutes before

measure again.

- The oximeter is calibrated in the factory before sale. There is no

need to calibrate during its life cycle.

Cleaning

Maintenance

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 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.

Recommends user to return this device to the manufacturer

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 verify

operation of the pulse oximeter equipment.

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 device

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

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

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 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

2. Do not use caustic or abrasive cleaning agents, or

any cleaning agent containing ammonium chloride or

isopropyl alcohol.

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. Model: SB200

www.rossmax.com

IN0SB200000000312

RI_IB_SB200(cont)_

EN_2Yr_TP_ver2036

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 con-

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

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 transmit-

ter / 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

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 environment.

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 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 loca-

tion 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

Rossmax InnoTek Corp.

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

CMC Medical Devices & Drugs S.L.

C/ Horacio Lengo N° 18, CP 29006, Málaga, Spain.

Fingertip Pulse Oximeter

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:

____________________________________________________

* The text is subject to change without further notice.

RI_IB_SB200(cont)_EN_2Yr_TP_ver2036.indd 1 2020/9/24 下午 04:13:56

Rossmax SB200 Handleiding

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