Rossmax SD100 Handleiding

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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% (w/w)

Ethanol) 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 de-

vice 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 am-

monium 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 function-

al damage or deterioration.

- Ensure all user interface keys and accessories func-

tion normally.

Note: Manufacturer use Index2 SpO2 simulator to

verify operation of the pulse oximeter device.

SymptomsCheck pointsCorrections

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 con-

sult with your physi-

cian if you are sure the

device works well.

SpO2 or

pulse rate are

not displayed

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

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%).

Accuracy70%~99%: ±2%, Below 35~69%:

unspecied.

Optical SensorThe 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 sourceAAA × 2 (Alkaline)

Battery lifeContinually for 16 hours with two alkaline

batteries

Operating

Condition

Temperature: 5°C~35°C (41°F ~ 95°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), The time

from 70°C or -25°C back to use : 3 hours

Dimensions61.3(L) × 31W) × 36.7(H) mm

WeightAbout 33g (without the batteries)

StandardsIEC60601-1-2, Class B, IEC60601-1, Type BF,

ISO80601-2-61, IEC/EN60601-1-11

Type BF applied parts

IP ClassicationIP22: Protection against harmful ingress of

water and particulate matter

Note:

- A description of the effect on displayed and transmit-

ted SpO2 and pulse rate:

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

pulse rate.

- Data update delay: Less than 2 seconds.

be evaluated at the measurement site. Rather, they

are exclusively used to display the current signal vari-

ation at the measurement site and do not enable re-

liable diagnostics for the pulse.

- A warning that other cables and accessories may

negatively aect EMC performance.

- A warning regarding stacking and location close to

other equipment.

- A warning that use of other accessories results in

non-compliance.

- The safety way in high-temperature environment for

all people use is measuring for 10 minutes, and turn

it o for 20 minutes before measure again.

- The oximeter is calibrated in the factory before sale,

there is no need to calibrate it during its life cycle.

Model: SD100

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.

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 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=[7/

E1]√P

0.010.10.10.2

0.10.40.40.7

11.21.22.3

103.73.77.4

10011.711.723.3

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.

Emissions testComplianceElectromagnetic environment - guidance

RF emissions CISPR 11Group 1Portable 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.

RF emissions CISPR 11Class BThe 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 61000-3-2N/A

Voltage uctuations/Flicker emissions

IEC 61000-3-3

N/A

Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are use in the professional health-

care facility environment or in the home healthcare environment

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 testIEC 60601 test levelCompliance levelElectromagnetic environment - guidance

Conducted RF IEC

61000-4-6

3 Vrms ; 6 Vrms ; 150

kHz to 80 MHz

N/APortable 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 ap-

plicable 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 ; 10V/m ; 80

MHz – 2.7 GHz l 80%

3 V/m ; 10V/m ; 80

MHz – 2.7 GHz ; 80%

Proximity elds

from RF wireless

Communications

equipment IEC

61000-4-3

27 V/m385 MHz27 V/m385 MHz

28 V/m450 MHz28 V/m450 MHz

9 V/m710 MHz9 V/m710 MHz

745 MHz745 MHz

780 MHz780 MHz

28 V/m810 MHz28 V/m810 MHz

870 MHz870 MHz

930 MHz930 MHz

28 V/m1720 MHz28 V/m1720 MHz

1845 MHz1845 MHz

1970 MHz1970 MHz

28 V/m2450 MHz28 V/m2450 MHz

9 V/m5240 MHz9 V/m5240 MHz

5500 MHz5500 MHz

5785 MHz5785 MHz

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 testIEC 60601 test levelCompliance levelElectromagnetic environment - guidance

Electrostatic discharge

(ESD) IEC 61000-4-2

±8 kV contact

±2 kV, ±4 kV, ±8 kV,

±15 kV air

±8 kV contact

±2 kV, ±4 kV, ±8

kV, ±15 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

N/AMains power quality should be that of a typical

commercial or hospital environment.

Surge IEC 61000-4-5±0.5 kV

±1 kV dierential mode

±2 kV common mode

N/AMains 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

0 % U

T

; 0, 5 cycle At 0°, 45°,

90°, 135°, 180°, 225°, 270°

and 315°

0 % U

T

; 1 cycle And 70

% U

T

; 25/30 cycle Single

phase: at 0°

N/AMains 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 sup-

ply or a battery.

Power frequency (50/60

Hz) magnetic eld IEC

61000-4-8

30 A/m30 A/mPower frequency magnetic elds should be at

levels characteristic of a typical location in a typi-

cal commercial or hospital environment.

Warranty Card

This instrument is covered by a 2 years 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:

___________________________________________

IN0SD100000000011

RI_IB_SD100_EN_

TP_ver2214

Product specificaties