Rossmax SA310 Manual de Usario

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SpO2
Measuring range 35% – 100% (the resolution is 1%)
Accuracy 70% – 100% (No Motion. ±2%, Motion. ±3%, Low Perfusion. ±2%)
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
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 ~ 1013hPa
Storage /Transport
Condition Temperature: -20°C – 70°C (-4°F – 158°F), Relative Humidity:15% – 95%(non
condensing), Atmospheric pressure: 700hPa ~ 1013hPa
Note: The condition of -20°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
IP22: Protected against foreign objects and moisture
CE Mark
Warning: the symbol on this product means that its 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.
Contains of natural rubber latex
Symptoms Check points Corrections
SpO2 or Pulse rate
cannot displayed
The icon “- -“ shows on the
screen 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.
try again
SpO2 or Pulse rate are
not displayed stably
Finger is shaking or body is moving Keep body steady
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 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.
Note: After clearing data, the icon will show 0 data.
Caution: The deleted data could not be restored.
Warning
Cleaning
Memories mode- Save Cycle
Memories mode- Clear Data
Specication
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. 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 [ME EQUIPMENT or ME SYSTEM], 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 nger, or re-position the
device.
This device is a precision electronic instrument and must be repaired by qualied 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.
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 -20°C ~ 70°C ambient temperature and not higher
than 95% 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.
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 à
Beep for 2 seconds Press button
Software
version àstart measure
2Pulse
search The icon X X
3
Max./ Min
SpO2 and
Pulse rate
warning
Show or in red icon.
limits.
Beep-beep sounded
repeatedly Default
Mute for temporary, will
Beep-beep sounded
after two minutes. mode
mode
Bar Chart
Entry “Data History, press the / button to highlight “Bar Chartoption 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 App
Entry into “Data History, press the / button to highlight “Memory Transferoption, 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
The icon shows
on the screen Beep-beep sounded
repeatedly X
5
Probe
connect
failure
alarm
The icon shows
on the screen Beep-beep sounded
repeatedly x
6Low
battery
alarm
The icon shows
on the screen
Beep-beep sounded
repeatedly for 1 minute x
7Automatic XBeep-beep sounded After pulse is unde-
tectable for around
1 minute.
8Unable
measure
Blood saturation
& pulse rate
appears “ - -
Beep-beep sounded
repeatedly. x
9 AC Power icon X X
Model: SA310
www.rossmax.com
Handheld Pulse Oximeter
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
by the manufacturer. Otherwise, degradation of the performance of this device could result.
Manufacturers declaration-electromagnetic immunity
of the SA310 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
amateur 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
amateur radio bands
between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the SA310 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
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in metres (m).
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
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
NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.
More information on EMC compliance of the device may be obtained from Rossmax using the contacts shown
in this manual.
IN0SA311000000030
RI_IB_SA310_EN_2Yr_
TP_ver1838
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:
__________________________________________________________________
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
Introduction
Probe connection
Sound volume control
Bluetooth Setup
How to Change Default Setting
Date Setup
Alarm Pulse Rate Setup
Memories mode –Memory On
Time Setup
Alarm SpO2 Setup
Default Setting
How to measure
Power installation
Name/ Functions of each part
Rossmax Handheld Pulse Oximeter is used to measure oxygen saturation in blood (SpO2) and
pulse rate, also to issue warnings immediately. It is a non-invasive device intended for spot-check
of adults, child, and infants with corresponding probe applied at home, hospital and clinics.
Attention: Consult the accompanying documents. Please read this manual carefully before
use. Please be sure to keep this manual.
Rossmax PA100/PB100/PC100/PD100/PF1000 or compatible probe is used. (Please install carefully.)
Caution: It may damage the efficiency of the device if not apply with a Rossmax compatible probe.
Press the button to control the
sound volume.
for loud volume.
for silence.
Adjust the bluetooth setting by press
the button
Press the button to enter the “Settings” mode and press / to scroll through option.
Press button to select desired option.
To exit setting, select “ Back/Exit” or wait for 30 second.
Press the button and / button to highlight “Date” option, and then press the
button to select the option.
Entry “Settings Date” mode, press the / button to highlight the desired option and 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 to highlight another option or select “Back/Exit” to return.
Adjustment Range: 180, 175, 170 … 50, 45, 40.
The Unit of Adjustment: 5 BPM / per unit
Press the button and / button to highlight “Alarm PR” option, and then press the
button to select the option.
Entry Alarm PR” mode, press the / button to highlight the desired option and 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 to highlight another option or select “Back/Exit” to return.
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 “Memory Ooption, and then
press the button to select the “Memory On” option.
Press the / button to highlight another option or select “Back/Exit” to return.
Press the button and / button to highlight “Time” option, and then press the
button to select the option.
Entry Settings Time” mode, press the / button to highlight the desired option and
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 to highlight another option or select “Back/Exit” to return.
Adjustment Range: 96, 95, 94 … 83, 82, 81, 80.
The Unit of Adjustment: 1 % / per unit.
Press the button and / button to highlight Alarm SpO2” option, and then press the
button to select the option.
Entry Alarm SpO2” mode, press the / button to highlight the desired option and 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 to highlight another option or select “Back/Exit” to return.
1. Press the Power On button for 1 second, when the device activates, the beep sound will
last for 2 second.
Note: After the device activates, the software version will pop up directly. For first time activates,
please refer to setting instruction.
2. Information of software version appears; insert one finger to probe, nail side up, for self-test.
Note: The device will turn itself off automatically after 1-minutes idling with two beep sounded.
3. The pulse strength shows “ , pulse oximeter begins its measurement.
Note: The heartbeat is sounded though the buzzer. If need to become silence mode, press the
sound button and the LCD screen will have the sound icon shown. If need the
heartbeat sound, press the sound button to exit.
Notes: 1. Don’t remove your finger until the measurement is completed.
2. Any other problems or unrecognized icon, please refer to trouble shooting.
Power can be supplied either by batteries or AC power cable.
AC power cable:
Plug AC power cable into AC power source and printout socket. Icon as ” show on the display.
Note: Once AC power is on, the power supply of the device is switched to AC power. Once AC
power is off, the power supply of the device is switched to battery power.
Batteries:
1. Use thumb to slide battery cover out.
2. Insert or replace 4 “AA” batteries according to the (+/-) polarity.
Caution: Need to replace when the batteries icon “ ” is blinking on display/ while pressed the
function button and nothing appears on display.
Caution: Batteries may leak or explode if used or disposed of improperly. Remove batteries if the
device will be stored for long time. Do not use different types or brand of batteries at the
same time.
No. Item Purpose
1 Sound icon loud volume / silence
2 SpO2 icon
SpO2 real-time value
3 Pulse Rate
Pulse rate real-time value
/
4 Pulse strength
5 Date/Time Show the Date (MM/DD/YYYY) / Time
6 Power status icon
Battery: Full batteries / Critically Low-Battery
AC Power: AC power on
7 Alarm icon Alarm pause for 2 minutes
8 Bluetooth icon
9 Memory icon Collection of Memories Up to 999 memories
10 Bluetooth button Press to turn on / off the Bluetooth function
11 Sound button Press to turn on / off the heartbeat sound
12 UP/DOWN button Press to scroll options and change value
13 SET button Press to adjust default setting / Press to select the option
14 Alarm button Press to pause alarm. To turn off alarm permanently, please entry
“Settings” mode to set up.
15 Power button Press to power on/off
16 it’s for AC Adaptor.
Date: 2018/01/01 Alarm PR: 100 High / 60 Low Alarm SpO2: 86%
Time: 00:00:00 Memory: OFF
Memories mode- Data History
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 Date History” option, and then
press the button to select the option.
Loud volume
Wireless o
Silence
Wireless on
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Alarm PR
Back
100
60
High
Low
Alarm On
Alarm PR
100
60
High
Low
Back
Alarm On
Alarm PR
1
Back
Ala
Alarm PR
1
Back
Al
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Settings
Date
Time
Alarm SpO
Alarm PR
Memory
Exit
2
Alarm PR
Back
100
60
Hig
Low
Alarm On
Alarm PR
100
60
Hig
Low
Back
Alarm On
or
96
95
94
:
:
82
81
80
start data
transmission
for a few secs.
180
175
170
:
:
50
45
40

Especificaciones del producto

Marca: Rossmax
Categoría: medidor de azúcar en sangre
Modelo: SA310

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