rossmax SA120 Handheld Pulse Oximeter User Manual

SA120 Handheld Pulse Oximeter
User Manual Handheld Pulse Oximeter
www.rossmax.com

Introduction

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. The probe contains a dual light source and a photodetector.
Attention: Consult the accompanying documents. Please read this manual carefully before use. Please be sure to keep this manual.

Name/Functions of each part

loud volume
lower volume
silence
5| Time| Shows the time
6| SpO2 icon| High SpO2
Low SpO2
7| Pulse Rate| High Pulse Rate
Low Pulse Rate
8| UP/DOWN button| For adjust/view all setting/ memory **M** memory icon
9| Set button| For view/ adjust default setting
10| Alert button| Alert off / Alert pause
11| Power button| Power on/ off
12| Battery compartment| For install or replace batteries
Full batteries
out of batteries

Battery installation

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.

Probe connection
Rossmax PA100/ PC100 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.

How to measure

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 SA120 All symbols time activates, it will directly jump to time setting. (Please refer to setting instruction.)

2. Information of software version appears; insert one finger to probe, nail side up, for self-test.
   Notes: The device will turn itself off automatically after 1 minute idling with two beep sounded.

3. The pulse strength shows “ “, pulse oximeter begins its measurement.
   Notes: 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.

4. Your SpO2 and pulse rate values will appears on the screen after few seconds.

Notes:

1. Don’t remove your finger until the measurement is completed.
2. Any other problems or unrecognized icon, please refer to trouble shooting.

Preview Default Setting

1. Press the button 1 second to preview default setting value.
2. Press to exit preview default mode or wait for 3 second for automatically.

How to Change Default Setting

Press the button 2 second to enter the set up mode and change default. For jump to next setting, press after finishing. To exit, press or wait for 10 second. SPO2 mode
• To setup Max SpO2rate, press to enter, and it shows as All symbols picture and press button for adjustment. To set up Min SpO2 rate, press , and it shows as picture and same as max setting.
Pulse Rate mode • To setup Max Pulse rate, press All symbols  to enter, and it shows as picture and press button for adjustment. To set up Min Pulse rate, press , and it shows as picture and same as max setting.
Memory interval mode

1. Optional of SA120: 5 / 10 / 30 / 60 minutes.
2. While the memory mode, the memory interval mode appears on the screen. To change the default, press to change (5)-(10)-(30)-(60) or (60)-(30)-(10)-(5) minutes.

Sound volume control

• For the control of sound volume, for loud volume, for lower volume. To change the sounds volume, Press to change – -> .
Time Setup
• To set up the time, it starts from year as picture, and press to adjust. Following the same  frequency for month, date, hourto minutes.

Memories reading and delete

Enter the memory mode with the to read the SpO2 and pulse rate in memory mode.
Note: When entering the memory reading mode, the will appear on the screen.

Press for two second during the memory reading mode, it will enter the memory delete mode. The screen show means not to delete any data, while the screen with , it means to delete data.
Caution: The deleted data could not be restored.

Audio Signals

No

| Name| LCD Display| Sound|

Control

---|---|---|---|---
1| Power on| All symbols
software version
start measure| Beep for 2 second| Press  for 1 second
2| Pulse search| The icon flickers| X| X
3| Max./ Min SpO2 and Pulse rate warning| or and yellow backlight flickers| Beep-beep sounded repeatedly| Default
Mute for temporary, will beep-beep sounded after two minutes.|  mode
Mute before power off|  mode
4| Probe failure alert| shows on the screen and yellow back light flicker| Beep-beep sounded repeatedly| X
5| Low battery alert| shows on the screen and yellow backlight flickers.| Beep-beep-beep sounded repeatedly for 1 minute and power off/| x
6| Automatic Off| X| Beep-beep sounded and then power off| After pulse is undetectable for around 1 minutes.
7| Unable measure| Blood saturation & pulse rate appears (- -) and yellow backlight flickers.| 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

Specification

SpO2

Measuring range| 35% – 100% (the resolution is 1%)
Accuracy| 70% – 100%: ±2 %, 35% – 69%: unspecified
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 Specification
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
| EU representative
---|---
| Type BF (Body Floating
IP Classification| 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.

Troubleshooting

Symptoms

| Check points|

Corrections

---|---|---
SpO2 or Pulse rate cannot displayed| The icon “- -“ shows on the screen| Place the finger properly and try again
This icon shows on the screen means probe dysfunction| Be sure”Rossmax” probe is connected to the device correctly.
Applied finger improperly| Place the finger properly and try again
SpO2 or Pulse rate are not displayed stably| Finger is shaking or body is moving| Keep body steady
Applied finger improperly| Place the finger 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 off when it gets no signal| Normal
Low battery| Replace with new batteries

Warning

• 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. trembling)
  – 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-diagnose 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.

• 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.

• The product is with a service life of 5 years in the course of regular use.

• If any serious incident (e.g. death) has occurred in relation to device should be reported to the dealer, manufacturer, and the competent authority of the Member State in which the user and/or patient is established.

Cleaning

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.
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.

Maintenance

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 specified below. The customer or the user of the Handheld 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 fluctuations/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 specified 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 fields 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 specified 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 floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fasttransient/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 differential mode
±2 kV common mode| N/A| Mains 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 61000-4-1| 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 field IEC 61000-4-8| 30 A/m| 30 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in atypical commercial or hospital environment.

Warranty Card
This instrument is covered by a 2 years 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: _

• The text is subject to change without further notice.

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

References

• Your Total Healthstyle Provider - Rossmax | Your total healthstyle provider
• Your Total Healthstyle Provider - Rossmax | Your total healthstyle provider

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