783661

Rossmax SA300 Handleiding

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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(Single Use), PF100
Extension cord Rossmax PE100
Optical Sensor The wavelength of red LED is 660nm and Infrared LED is 905/880nm with
maximum optical output power of 4mW.
Electrical Specication
Battery AA * 4 (Alkaline)
Battery Life Continually for 15 hours with 4 alkaline batteries
AC Adaptor Model: HK-X205-A06, HK-XW05-A06, (W=1,2,3,4), HKKS-13116, HKKS-13117
Input: AC100-240V, 50/60Hz, 0.2A max; Output: DC 6V, 0.8A
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
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.
Symptoms Check points Corrections
SpO2 or Pulse rate
cannot displayed
-
-
- -
% SpO2
Artery
Check
BPM
ACT PPG
The icon “- -“ shows on the
screen Place the nger properly and
try again.
ACT PPG
This icon means probe
connect failure.
Be sure ”Rossmax” probe is
connected to the device
correctly.
ACT PPG
This icon means probe
dysfunction Replace with new probe.
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
Note: After clearing data, the icon will show 0 data.
Caution: The deleted data could not be restored.
Warning
Cleaning
Maintenance
Memories mode- Save Cycle
Memories mode- Clear Data
Specification
Troubleshooting
Audio Signals
• 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.
• 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.
• 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.
• The maximum temperature might reach 42.4°C when operating for long time.
• The oximeter is calibrated in the factory before sale, there is no need to calibrate it during its life
cycle.
• Do not reuse or disinfect disposable SpO2 probe. (only for PD100)
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 clean 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 Index2 SpO2 simulator to verify operation of the pulse oximeter device.
Optional of memory interval: 60 / 30 / 10 seconds
• Press the button and / button to highlight “Memory” option, and then press the
button to select the option.
• Entry “Memory Mode”, press the / button to highlight “Save Cycle” option, and then press
the button to select the option.
• Entry “Save Cycle”, press the / button to highlight option, and then press the button
to select the option.
• Press the / button to change the value; press the button to save the desired value.
• Press the / button and the button to select “Back/Exit” to return.
• Press the button and / button to highlight “Clear Data” option, and then press the
button to select the option.
• Entry “Clear Data”, press the / button to highlight “Sure” option, and then press the
button to select the option.
• Press the / button and the button to select “Back/Exit” to return.
No. Name LCD Display Sound Control
1 Power on
V0.00
0
0
% SpO2
Artery
Check
BPM
288
M
ACT PPG
Beep for 2 seconds Press button
Software
version start measure
2Pulse
search The icon ickers X X
3
Max./ Min
SpO2 and
Pulse rate
warning
Show or in red icon.
Reects upper or lower alarm
limits.
Beep-beep sounded
repeatedly Default
Mute for temporary, will
Beep-beep sounded
after two minutes. mode
Mute before power o mode
Bar Chart
• Entry “Data History”, press the / button to highlight “Bar Chart” option for viewing statistics
of SpO2, and then press the button to select the option.
• Entry “SpO2 Memory Data”, press the button to go back to the monitoring screen.
Memory Transfer to ROSSMAX Software
• Entry into “Data History”, press the / button to highlight “Memory Transfer” option, and
then press the button to start data transmission for a few seconds.
Note: Before entering the data history mode, the icon should collect more than 1 data.
4Probe
failure
alarm
ACT PPG
The icon shows
on the screen Beep-beep sounded
repeatedly X
5
Probe
connect
failure
alarm
ACT PPG
The icon shows
on the screen Beep-beep sounded
repeatedly x
6Low
battery
alarm
ACT PPG
The icon shows
on the screen
Beep-beep sounded
repeatedly for 1 minute
and power o x
7Automatic
O XBeep-beep sounded
and then power o
After pulse is unde-
tectable for around
1 minute.
8Unable
measure - -
- -
% SpO2
Artery
Check
BPM
ACT PPG
Blood saturation
& pulse rate
appears “ - - “
Beep-beep sounded
repeatedly. x
9 AC Power icon XRemove or connect
AC power cable to
device.
Note: 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.
• Alarm condition delay: Less than 8 seconds for SpO2; Less than 16 seconds for pulse rate.
• Alarm signal generation delay: Less than 1 second for SpO2 and pulse rate.
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. Model: SA300
www.rossmax.com
Handheld Pulse Oximeter
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Save Cycle
60Sec
Back
Save Cycle
30Sec
Back
Save Cycle
10Sec
Back
Save Cycle
10Sec
Back
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Clear Data
Back
Sure
Clear Data
Back
Sure
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Save Cycle
60Sec
Back
Save Cycle
30Sec
Back
Save Cycle
10Sec
Back
Save Cycle
10Sec
Back
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Clear Data
Back
Sure
Clear Data
Back
Sure
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Save Cycle
60Sec
Back
Save Cycle
30Sec
Back
Save Cycle
10Sec
Back
Save Cycle
10Sec
Back
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Clear Data
Back
Sure
Clear Data
Back
Sure
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Save Cycle
60Sec
Back
Save Cycle
30Sec
Back
Save Cycle
10Sec
Back
Save Cycle
10Sec
Back
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Clear Data
Back
Sure
Clear Data
Back
Sure
Memory Mode
Back
Clear Data
Save Cycle
Data History
Memory Off
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
60/30/10
seconds
Electromagnetic Compatibility Information
1. This device needs to be installed and put into service in accordance with the information provided in the user manual.
2. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the SA300, including cables specied by the manufacturer.
Otherwise, degradation of the performance of this device could result.
If higher IMMUNITY TEST LEVELS than those specied in Table are used, the minimum separation distance may be lowered. Lower
minimum separation distances shall be calculated using the equation.
Manufacturer’s declaration-electromagnetic immunity
The SA300 is intended for use in the electromagnetic environment specied below. The customer or the user of the SA300
should assure that is used in such and environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms: in ISM and ama-
teur radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms: in ISM and ama-
teur radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
SA300 including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P, d = 1,2 √P 80MHz to 800 MHz, d = 2,3 √P
800MHz to 2,7 GHz
IN0SA300000000031
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:
__________________________________________________________________________
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
Radiated RF IEC
61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reec-
tion from structures, objects and people.
More information on EMC compliance of the device may be obtained from Rossmax using the contacts shown in this manual.
The text is subject to change without further notice.
RI_IB_SA300_EN_2Yr_
TP_ver2041
RI_IB_SA300_EN_2Yr_TP_ver2041.indd 1 2020/10/6 下午 06:47:31
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