Handleiding Rossmax SA120 Pulse-oxymeter

Handleiding

Audio Signals

Specification

Troubleshooting

Warning

Cleaning

Maintenance

No Name LCD Display Sound Control

1 Power on

SA210 All symbols

All symbols

SA210 All symbols

software

version

SA210 All symbols

start measure

Beep for 2 second

Press

for

1 second

2

Pulse

search

The icon ickers

X X

3

Max./ Min

SpO2 and

Pulse rate

warning

or and yellow

backlight ickers

Beep-beep

sounded repeatedly

Default

Mute for temporary,

will beep-beep

sounded after two

minutes.

mode

Mute before power

o

mode

4

Probe

failure alert

shows on the screen

and yellow back light icker

Beep-beep

sounded repeatedly

X

5

Low

battery

alert

shows on the screen

and yellow backlight ickers.

Beep-beep-beep

sounded repeatedly

for 1 minute and

power o/

x

6

Automatic

O

X

Beep-beep

sounded and then

power o

After pulse is

undetectable

for around 1

minutes.

7

Unable

measure

Blood saturation & pulse

rate appears (- -) and yellow

backlight ickers.

Beep- beep

sounded

repeatedly.

X

8

Data

Updated

Period

Less than 2 seconds. X X

9

Alert

Condition

Delay

Less than 8 seconds for

SpO2. Less than 16 seconds

for pulse rate.

X X

10

Alert Signal

Delay

Less than 1 second for SpO2

and pulse rate

X X

SpO2

Measuring range 35% – 100% (the resolution is 1%)

Accuracy 70% – 100%: ±2 %, 35% – 69%: unspecied

Pulse Rate

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

Accuracy 30 – 250 ± 3 digits

Probe Type

Probe model Rossmax PA100, PB100, PC100, PD100, PF100

Extension cord Rossmax PE100

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.

Electrical Specication

Battery AA * 4 (Alkaline)

Battery Life Continually for 15 hours with 4 alkaline batteries

Environmental conditions

Operation

Condition

Temperature: 5°C – 40°C (41°F – 104°F), Relative Humidity:15%

– 95%(non condensing), Atmospheric pressure: 700hPa ~

1060hPa

Storage /

Transport

Condition

Temperature: -25°C – 70°C (-13°F – 158°F), Relative

Humidity:15% – 90%(non condensing), Atmospheric pressure:

700hPa ~ 1060hPa

Note: The condition of -25°C or 70°C back to use should stand

for 3 hours at room temperature.

Dimension Size: 14.5(L) x 7.25(W) x 2.25cm(H)

Weight About 150g (without the batteries)

Standard IEC/EN60601-1, IEC/EN60601-1-2, IEC/EN60601-1-11,

ISO80601-2-61

Symbol Descriptors

Manufacturer

Serial number

Symptoms Check points Corrections

SpO2 or Pulse rate

cannot displayed

The icon “- -“ shows on the

screen

Place the nger properly

and try again

This icon

shows on

the screen means probe

dysfunction

Be sure”Rossmax” probe is

connected to the device

correctly.

Applied nger improperly

Place the nger properly

and try again

SpO2 or Pulse rate

are not displayed

stably

Finger is shaking or body is

moving

Keep body steady

Applied nger improperly

Place the nger properly

and try again

No display when

the

bottom is

pressed

Batteries run down Replace with new batteries

Batteries inserted incorrectly 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.

• 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 per- son 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.

• This device only for spot-checking, but not medical result evaluation.

• This device is designed to determine the percentage of arterial oxygen saturation of functional

hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of

the measurement include the following:

- Do not apply the pulse oximeter on the same arm as a blood pressure cuff, arterial catheter

or infusion line (s).

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

- Not steady at the site of application (e.g. term-bling)

- Moisture in the device

- Improperly applied device

- Finger is too large or too small to fit into the device

- Poor pulse quality

- Venous pulsations

- Anemia or low hemoglobin concentrations

- Cardio green and other intravascular dyes

- Carboxyhemoglobin

- Methemoglobin

- Dysfunctional hemoglobin

- Artificial nail or fingernail polish

- On fingers with anatomical changes, oedemas, scars or burns.

- The conditional of probe. Use only the Rossmax approved pulse oximeter sensor, cable and

accessories. These parts are not reprocessed. Use of other sensors, cable and accessories

can result in inaccurate readings.

• Using the device for long periods may cause pain for people with circulatory disorders.

Reposition the device (probe) 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 Pulse oximeter, including cables specified by the manufacturer.

• The device will be affected by electromagnetic interference during operation.

• A warning that other cables and accessories may negatively affect EMC performance.

• 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 not 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-diagonse 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.

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.

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 ~ 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 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 Index 2 simulator to verify operation of the pulse oximeter

equipment.

EMC guidance and manufacturer’s declaration

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

The Handheld Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus-

tomer or the user of the Handheld Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between

portable and mobile RF communications equipment (transmitters) and the Handheld 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

0.01 0.1 0.1 0.2

0.1 0.4 0.4 0.7

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 11.7 11.7 23.3

Declaration – electromagnetic emissions

The Handheld Pulse Oximeter is intended for use in the electromagnetic environment specied below. The customer or the user of the Hand-

held Pulse Oximeter should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11 Group 1 The Handheld 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 Handheld Pulse Oximeter is suitable for use in all establishments,

including domestic establishments and those directly connected to the

public low-voltage power Harmonic emissions supply network that sup-

plies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2 N/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 healthcare facility

environment or in the home healthcare environment

The Handheld Pulse Oximeter declaration – electromagnetic immunity

The Handheld Pulse Oximeter system is intended for use in the electromagnetic environment specied below. The customer or the user of the

Handheld 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 ; 6 Vrms ; 150 kHz

to 80 MHz

N/A 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 equip-

ment 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 Communi-

cations equipment IEC

61000-4-3

27 V/m 385 MHz 27 V/m 385 MHz

28 V/m 450 MHz 28 V/m 450 MHz

9 V/m 710 MHz 9 V/m 710 MHz

745 MHz 745 MHz

780 MHz 780 MHz

28 V/m 810 MHz 28 V/m 810 MHz

870 MHz 870 MHz

930 MHz 930 MHz

28 V/m 1720 MHz 28 V/m 1720 MHz

1845 MHz 1845 MHz

1970 MHz 1970 MHz

28 V/m 2450 MHz 28 V/m 2450 MHz

9 V/m 5240 MHz 9 V/m 5240 MHz

5500 MHz 5500 MHz

5785 MHz 5785 MHz

Declaration – electromagnetic immunity

The Handheld Pulse Oximeter system is intended for use in the electromagnetic environment specied below. The customer or the user of the

Handheld 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

±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/A Mains 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/A Mains power quality should be that of a typical

commercial or hospital environment.

EU representative

Type BF (Body Floating

IP Classication IP22: Protected against foreign objects and moisture

CE Mark

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.

• Do not look directly inside the housing during the measurement. The red light and the

invisible infra-red light in the probe are harmful to your eyes.

• Please be aware that user with susceptible skin.

• As with all medical equipment, carefully route patient cabling to reduce the possibility of

patient entanglement or strangulation.

• A warning regarding stacking and location close to other equipment.

• Do not reuse or disinfect disposable SpO2 probe. (only for PD100).

• A warning to the effect that the responsible organization or operator needs to verify the

compatibility of the monitor, probe, and cable before use, otherwise patient injury can result.

• The oximeter is calibrated in the factory before sale, there is no need to calibrate it during its

life cycle.

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/A Mains power quality should be that of a typical

commercial or hospital environment. If the user

of the EQUIPMENT or SYSTEM requires contin-

ued operation during power mains interrup-

tions, 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

30 A/m 30 A/m Power frequency magnetic elds should be

at levels characteristic of a typical location in a

typical commercial or hospital environment.

RI_IB_SA120_EN_

TP_ver2021

Warranty Card

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

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:

_____________________________________________________

Model: SA120

www.rossmax.com

IN0SA120000000060

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

Handheld Pulse Oximeter

* The text is subject to change without further notice.

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