Rossmax SA310 Manual

Rossmax Pulsmåler SA310

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Side 1/2

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

BPM

- -

% SpO

The icon “- -“ shows on the

screen Place the nger properly and

try again.

This icon means probe

connect failure.

Be sure ”Rossmax” probe is

connected to the device

correctly.

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. 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.

• 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.

• 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)

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

• If any serious incident (e.g. death) has occurred in relation to the device should be reported to

the dealer, manufacturer, and the competent authority of Member State in which the user and/or

patient is established.

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 clean the product after use, prevent from cross infection for next

time use.

3. The best storage environment of the device is -25°C °C ~ 70 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 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 

15:36

09 / 14 / 2018

BPM

999

% SpO

2Beep for 2 seconds Press button

Software

version start measure

2Pulse

search The icon ickers X X

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

15:36

09 / 14 / 2018

The icon shows

on the screen Beep-beep sounded

repeatedly X

Probe

connect

failure

alarm

15:36

09 / 14 / 2018

The icon shows

on the screen Beep-beep sounded

repeatedly x

6Low

battery

alarm

15:36

09 / 14 / 2018

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

15:36

09 / 14 / 2018

BPM

- -

% SpO

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: SA310

www.rossmax.com

Handheld Pulse Oximeter

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Memory Mode

Back

Clear Data

Save Cycle

Save Cycl

Save Cycle

Data History

Memory Off

Memory Mode

Back

Clear Data

Save Cycle

Data History

Memory Off

Save Cycle

10Sec

Back

Clear Data

Back

Sure

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 SA310, 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.

IN0SA311000000031

RI_IB_SA310_2Yr_

EN_TP_ver2043

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

Manufacturer’s declaration-electromagnetic immunity

The SA310 is intended for use in the electromagnetic environment specied below. The customer or the

user 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 calcu-

lated from the equation applicable to the fre-

quency 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 rat-

ing 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 sym-

bol:

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.

NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorp-

tion and reection 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.

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.

Note: If the icon appears, 

it means the Bluetooth

module is malfunctioning.

• 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.

Note:

1. Press , the device will turn off and the setup value will be reserved.

2. Waiting for 30 seconds to exit, the setup value will be reserved. Please check the setting value

before use.

• 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 Off” option, 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.

Note: Don’t regard “ ” icon as whether the AC power supply is normal.

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

Reects lower SpO2 warning.

3 Pulse Rate

Pulse rate real-time value

/ Reects upper and lower pulse rate warning.

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 cable connected

7 Alarm icon Alarm o / Alarm pause for 2 minutes

8 Bluetooth icon For Bluetooth on / o for real-time data transmission

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.

15:36

09 / 14 / 2018

% SpO

BPM

999

Low

High

Low

High

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Setting Date

Back

YYYY/MM/DD

Year

Month

Date

Setting Time

Back

Hour

Min

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

A Olarm Sp

larm Sp

Alarm PR

Memory

Exit

Alarm SpO

Back

Alarm Off

Alarm SpO

Back

Alarm On

Loud volume Silence

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Alarm PR

Back

100

High

Low

Alarm On

Alarm PR

100

High

Low

Back

Alarm On

Alarm PR

100

High

Low

Back

Alarm On

Settings

Date

Time

Alarm SpO

Alarm PR

Exit

Memory

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Memory Mode

Back

Clear Data

Save Cycle

Data History

Memory Off

Memory Of

Memory Off

Memory Mode

Back

Clear Data

Save Cycle

Data History

Memory On

180

175

170

Settings

Date

Time

Alarm SpO

Alarm PR

Memory

Exit

Memory Mode

Back

Clear Data

Save Cycle

Data History

Memory Off

Data History

Back

Memory

Transfer

Bar Chart

99 97 95 93 91 89 87 85

SpO Memory Data2

Data History

Back

Memory

Transfer

Bar Chart

start data

transmission

for a few secs.