783667

Rossmax SA120 Handleiding

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Audio Signals
Specification
Troubleshooting
Warning
Cleaning
Maintenance
No Name LCD Display Sound Control
1Power on
SA210 All symbols
All symbols
SA210 All symbols
software
version
SA210 All symbols
start measure
Beep for 2 second Press for
1 second
2Pulse
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
4Probe
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
6Automatic
O X
Beep-beep
sounded and then
power o
After pulse is
undetectable
for around 1
minutes.
7Unable
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
11.2 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 % UT; 0, 5 cycle At 0°, 45°, 90°,
135°, 180°, 225°, 270° and 315°
0 % UT; 1 cycle and 70 % UT;
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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