Model SA300, SA310 & SA320 Instructions for Use

Table of Contents 1. Safety information ………………………………………………………………… 2. Introduction………………………………………………………………………… 3. Features …………………………………………………………………………… 4. Product introduction ……………………………………………………………… 5. Operation ………………………………………………………………………… 5.1 Basic operation ……………………………………………………………… 5.2 Alerts ………………………………………………………………………… 5.3 Setup ………………………………………………………………………… 5.4 Alarm On/Off ………………………………………………………………… 5.5 Sound On/Off ………………………………………………………………… 5.6 LCD backlight control ………………………………………………………… 5.7 Power input control …………………………………………………………… 5.8 Wireless setup ………………………………………………………………… 6. Audio signals ……………………………………………………………………… 7. Technical specifications …………………………………………………………… Performance ……………………………………………………………………… Probe type ………………………………………………………………………… Electrical requirements …………………………………………………………… Environmental requirements ……………………………………………………… Physical characteristics …………………………………………………………… Standards Marking ………………………………………………………………… 8. Problem shooting ………………………………………………………………… Dysfunction and resolution ………………………………………………………… Cleaning …………………………………………………………………………… Disposal …………………………………………………………………………… EMI - Electromagnetic interference ……………………………………………… 9. Data transmission ………………………………………………………………… 10. Calibration …………………………………………………………………………

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1. Safety information

WARNING: The SpO2 device is to be operated by trained personnel only.

WARNING: Do not use the SpO2 device in the presence of flammable anesthetics to prevent explosion hazard.

WARNING: Do not use the SpO2 device in the Magnetic Resonance Imaging (MRI) ambience.

WARNING: The SpO2 readings and pulse signals can be affected by the conditions of ambience, probe, and patient.

WARNING: Do not open up the SpO2 device except for the battery cover. The SpO2 device is without any user-serviceable part inside and only qualified service personnel can perform maintenance service.

WARNING: Do not expose the SpO2 device to extreme moisture (such as rain) to ensure accurate performance and device safety.

WARNING: If the accuracy of measurement by the SpO2 device is uncertain, check the patient’s vital signs by alternate means.

Warning: This device is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

WARNING: Reposition the probe at least once every 4 hours to allow the patient’s skin to breath.

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WARNING: The SpO2 device is intended for the use of adult and individual over 40kgs only.

WARNING: Do not use the SpO2 device with other devices (such as, the cuff of blood pressure monitor) that may interfere with blood flow and cause inaccurate measurement.

Warning: The SpO2 device will be affected by electromagnetic interference during operation.

Warning: Please remove the batteries from the battery compartment if the device will not be used for a long period of time.

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Introduction The AC-powered handheld pulse oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse rate; also, to issue warnings instantly. The pulse oximeter is used on adults, child, and infant with corresponding probes applied at hospital, clinics, and/or home. The probe contains a dual light source (Red LED and Infrared red LED) and a photodetector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the probe, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW.

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Features ☆ Single turn-on key for easy operation. ☆ Adjustable backlight and LCD design for SpO2 and pulse rate display. ☆ SpO2 and pulse rate programming and warning function. ☆ On/Off switch of pulse rate indicator. ☆ On/Off switch of warning. ☆ Adjustment of sound volume. ☆ SpO2, heartbeat, and recorded data can be printed out with wire (SA300 and SA320) or wireless (SA310 and SA320). ☆ Powered with 4 AA alkaline batteries and/or AC-adapter. ☆ 72-hour recording and memory.

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Product introduction Top view 28

1 27

26

2 25 24 23

3 4 5 6 7

22 21

8

20

9

19

10 11

12

13 14

15

16

17

18

Front view

Back view

1

Probe connection

15

Power On/Off Button

2

Memory display

16

Alarm Button

3

Sound volume icon

17

SET button

4

Sound icon

18

Battery compartment

5

SpO2 icon

19

Battery indicator

6

Pulse strength

20

AC-power icon

7

Pulse rate

21

Low pulse rate indicator

8

Pulse search icon

22

High pulse rate indicator

9

PC-link

23

Low SpO2 indicator

10

Probe failure warning

24

High SpO2 indicator

11

LCD backlight button

25

Alarm pause indicator

12

Sound button

26

Alarm off indicator

13

”UP” Button

27

Time display

14

“Down” Button

28

AC power and transmission socket

6

5

Operation 5.1 Basic operation Battery installation or AC power Open up battery compartment cover with both hands evenly and carefully and then install four “AA” Alkaline batteries according to the (+/-) polarity. Plug AC power cable into AC power source and printout socket. Probe connection Rossmax PA100, or compatible probe is used (please check the pin lineup carefully for installation). Warning: It may damage the efficiency of the device if not apply with a Rossmax, or compatible probe. Plug the probe into the connection on the top of the device carefully (Fig. 5-1). If extension cord is needed, please use Rossmax, or compatible cord.

Fig. 5-1 Fig.5-1 Warning: The function of the device could be compromised with the use of extension cord other than Rossmax, or compatible cord. Power On ● Press the “power switch” key for 1 second to activate the device. ● The beep sound will last for 2 seconds to signal the power on of the device. ● All icons appear on the LCD screen and with backlight lasts for 60 seconds. ● The device is then in the “self-test” mode with the software version shown. ● The measurement starts at the completion of the “self-test.” ● The device is with a default of time setup mode (please refer to time setup).

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Pulse search ● The pulse search icon flickers once every second while the device is in idling. Yellow backlight flickers once per second with alarm on. ● The icon of pulse search will stop flickering while in use and it remains on the LCD screen. The pulse strength is shown from low to high. Measurement The readings of oxygen saturation, pulse rate, and pulse strength will appear on LCD screen in 8 seconds. While the probe is off, yellow backlight flickers once per second and with alarm on; also, the SpO2 and BPM readings will remain on the display for 10 seconds before off. If the measurement fails, the icon of “- -“will appear on LCD screen and with yellow backlight flickering once per second and two beeps sounded continuously. SpO2 (Fig. 5-2)

Fig.5-2 LCD icon design for an easy reading of 35%~100% Pulse rate (Fig. 5-3)

Fig. 5-3 LCD icon design for an easy reading of 30bpm~250bpm Pulse strength (Fig. 5-4)

Fig. 5-4 Pulse indicator shows the strength of heartbeat bottom up including the 8

frequency of heartbeat. Sound of heartbeat The heartbeat is sounded through the buzzer; therefore, the heartbeat rate is known from the frequency of sound. Press the “Sound Button” to silence the buzzer and the LCD screen will have the “sound icon” shown. Press the “Sound Button” again to exit the silence mode and the “sound icon” will disappear from the LCD icon and replaced by

or

instead.

LCD backlight control Press the “LCD backlight button” light is sufficient.

to turn off backlight while the ambient

Press the “LCD backlight button” the ambient light is insufficient.

again to turn on the backlight while

Memory reading and memory delete Enter the memory mode with the rate in memory.

or

to read out the SpO2 and heart

Enter the memory reading mode, the will appear on the screen and with the SpO2 and heart rate value shown; moreover, the recording time/date will be revealed too. If there is not any SpO2 and heart rate value in memory, the icon “- - “will appear on the screen and the any data stored in the memory.

is with 0 value shown. It means that is not

The memory is for a rolling recording with 288 data in total. Press out next memory data; press memory reading mode.

to call out prior data. Press

In the memory reading mode, press delete” mode. The screen shows data deleted, so please press mode.

and

that means not to have the

for 2 seconds to save data and exit the and

that means to

for 2 seconds to delete data and exit the mode.

The deleted data could not be restored. Press

to exit the

for 2 seconds to enter the “memory

Press the arrow key to have the screen shown have data deleted. Press

to call

to exit the memory reading mode. 9

Power off Press button for 2 seconds to turn off the device without any beep sounded. 5.2 Alerts Max. /Min. SpO2 Max. /Min. alarm While the alarm is activated (that is, the “ ” or “ ” is not on the screen) and SpO2 exceeds the Max./Min. threshold; the device will sound the alarm with two beeps continuously until pressing the “ ” to turn off the device; moreover, the will appear on the screen and with yellow backlight flickering once per second. If SpO2 continues to exceed the Max./Min. threshold after 2 minutes, the alarm will be activated again (alarm will go off continuously). The alarm will be off permanently if it is setup to be so (the “ “appears on the screen); however, the “ ” or “ ” and Yellow backlight will flicker once every second continuously. (Please refer to 5.4 “Alarm off”). The heartbeat sound is off while the alarm is on. Max. /Min. Alert flickering No matter the alarm is on or off (the “

” or “

” is on the

screen), the “ ” or “ ” and Yellow backlight flickers once every second continuously while the SpO2 exceeds the Max./Min. threshold. Max. /Min. pulse rate Max. /Min. alarm While the alarm is activated (that is, the “ ” or “ is not on the screen) and pulse rate exceeds the Max./Min. threshold; the device will sound the alarm with two beeps continuously until pressing the “ ” to turn off the device; moreover, the will appear on the screen and with yellow backlight flickering once per second. If pulse rate continues to exceed the Max./Min. threshold after 2 minutes, the alarm will be activated again (alarm will go off continuously). 10

The heartbeat sound is off while the alarm is on. Max. /Min. Alert flickering No matter the alarm is on or off (the “ ” or “ ” is on the screen), the “ ” or “ ” and Yellow backlight flickers once every second continuously while the pulse rate exceeds the Max./Min. threshold. Probe failure alarm If the probe is not properly attached to the device or if the probe is not Rossmax, Solaris compatible, the “ ” icon and Yellow backlight flicker once every second with alarm sounded continuously. Battery Low battery When the battery is low, batteries as soon as possible.

appears on the screen. Please replace the

When the battery is critically low, the “ ” icon and Yellow backlight flickers once every second with alarm sounded for 1 minute before the device is off automatically. When “ ” or “ “ is on the screen, the alarm is off and the ” ” and Yellow backlight flickers once every second for 1 minutes before the device is off automatically.

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5.3 Setup Preview Press the “

” button to enter the setup mode.

The Max. value of SpO2 (with a default value of 100), the Min. value of SpO2 (with a default value of 86), the Max. value of pulse rate (with a default value of 140), the Min. value of pulse rate (with a default value of 45) and memory interval setup (default value of 60 seconds) appear in that order at an interval of 2.5 seconds. The device will then exit the setup mode 2.5 seconds later. The buzzer icon ( on the screen continuously. Press the

or

) and date appears

button to exit the “setup” mode.

Max. SpO2 setup Press the “ ” button for 2 seconds to enter the setup mode. To setup of Max. SpO2, the “ “icon of SpO2 flickers once every second and with the Max. SpO2 appears. If no adjustment is needed, press

to setup the Min. value of SpO2 or wait 10 seconds to exit.

The default of Max. SpO2 is for 100. The highest SpO2 value setup is for 100%. Press

or

button for the adjustment.

For the value between 90 and 100: Press to show the following values: Current value → +1 → +2 → …… → 100, press SpO2. Press to the following values Current value → -1 → -2 → …… → Min. +1, press SpO2. For the value between 62 and 90: Press to show the following values: Current value → +2 → +4 → …… → 100, press SpO2. Press to show the following values: Current value → -2 → -4 → …… → Min. +2, press 12

to setup Min.

to setup Min.

to setup Min.

to setup Min.

SpO2. Press the

to exit the mode with having the default value saved.

Min. SpO2 While in the Min. SpO2 setup mode, the icon will flicker once every second and with the Min. SpO2 value shown on the screen. If adjustment of SpO2 is not needed, press setup mode or wait 10 seconds to exit.

to enter the Max. pulse rate

The default value of Min. SpO2 is 86. The lowest SpO2 value setup is for 60%. Press

or

for adjustment.

For the value between 90 and 99: Current value → +1 → +2 → …… → Max. –1, press pulse rate. Current value → -1 → -2 → …… → 60, press rate.

to setup Max.

to setup Max. pulse

For the value between 60 and 90: Current value → +2 → +4 → …… → Max. –2, press pulse rate. Current value → -2 → -4 → …… → 60, press rate. Press the

to setup Max.

to setup Max. pulse

to exit the mode with having the default value saved.

Max. pulse rate While in the Max. pulse rate setup mode, the icon will flicker once every second and with the Max. value shown on the screen. If adjustment is not needed, press to setup Min. pulse rate or wait 10 seconds to exit. The default value of Max. pulse rate is 140. Press

or

for adjustment.

Press to show the following values. Current value → +5 → +10 → …… → 250, press pulse rate. 13

to setup Min.

Current value → -5 → -10 → …… → Min. +5, press pulse rate. Press the

to setup Min.

to exit the mode with having the default value saved.

Min. pulse rate While in the Min. pulse rate setup mode, the icon will flicker once every second and with the Min. value shown on the screen. If adjustment is not needed, press to enter the memory interval mode (for SA120 and SA210 only) or enter the sound volume setup mode or wait 10 seconds to exit the setup mode. The default value of Min. pulse rate is 45. Press

or

for adjustment.

Press to show the following values. Current value → +5 → +10 → …… → Max. –5, press to enter the memory interval mode (for SA120 and SA210 only) or the sound volume setup mode. Current value → -5 → -10 → …… → 30, press to enter the memory interval mode (for SA120 and SA210 only) or the sound volume setup mode. Press the

to exit the mode with having the default value saved.

Memory interval mode While in the memory mode, the

and memory interval mode

appears on the screen. If no modification is needed, press the to enter the sound control mode or to wait for 10 seconds to exit the SET mode. The default of the memory is for 5 minutes. It could be set for 7 intervals including 2-second, 3-second, 5-second, 10-second, 30-second, and 60-second. “0” stands for no memory setup. Press the

or

to setup.

Press the and the following values appear: Current value (5)→(10)→(30)→(60), stay unchanged from this point on and press the

to enter the sound control mode.

Press the and the following values appear: Current value (10)→(5)→(3)→(2), stay unchanged from this point on and press the

to enter the sound control mode.

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Press the

to exit the mode with having the default value saved.

Sound volume control For the control of sound volume, the second. If adjustment is not needed, press 10 seconds to exit the setup mode. The default sound volume is shown as Press

or

Press

icon flickers once every to enter time setup or wait

.

for adjustment.

to show the following values:

For example: Current value (small volume) → (large volume), remains at without further change, press to exit the setup mode or to enter time setup. Press to show the following values. For example: Current value (large volume) → (small volume), remains at without further change, press to exit the setup mode or to enter time setup. The setup of sound volume will be signaled with a beep for 1 seconds except for Model the setup of mute ( ). Press the

to exit the mode with having the default value saved.

Time setup The time setup mode starts out with the “year,” “month,” “date,” “hour,” and “minute” by pressing the

. If no setup is needed,

wait for 10 seconds to exit the mode automatically. The default date of the device is at 0 hour 0 minute on January 1, 2000.

Setup the “year” first by pressing the or the of 01~99 (the last two digits of the year).

in the range

Press the to enter the “month” mode with the in the range of 1~12.

or the

Press the

or the

to enter the “date” mode with the 15

in the range of 1~31. Press the to enter the “hour” mode with the in the range of 0~23. Press the

to enter the “minute” mode with the

or the or the

in the range of 0~59. Press the Press the

again to exit the SET mode. to exit the mode.

Warning: Press setup value reserved.

to exit the mode and without having the

If the battery is not installed, the battery is low, or the battery is out of the compartment for over 30 minutes, date and time will resume the default value when the device is reactivated. 5.4 Alarm On/Off Alarm pause The power on setup is with an alarm sounded to remind that the value exceeds the alert threshold. Press to have appeared on the screen and it is without a warming sound in 2 minutes when it exceeds the alarm setup and the alarm will be reactivated after 2 minutes. Alarm off Press for 2 seconds and will appear on the screen and will flicker once every second that means no alarm will be sounded while the value exceeding the default Press for 2 seconds and icon will disappear from the screen that means the alarm will be sounded while the value exceeding the default.

Please be aware of this setup。 For probe failure, the alarm off or pause setup will be off automatically and the alarm will sound automatically. 16

The alarm setup is on while the unit is turned on. 5.5 Sound On/Off The sound setup is on while the power is on and the sound volume is shown as or . Press to turn off the sound of heartbeat and with the The sound setup is on while the unit is turned on.

shown.

5.6 LCD backlight control Press to turn off the LCD backlight while the ambient light source is sufficient for operation. Press again to turn on the LCD backlight while the ambient light source is insufficient for operation. Backlight turns off automatically in 60 seconds. 5.7 Power input control Power input by battery or AC adapter. 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. 5.8 Wireless setup Adjust the “arrow up”

key and “arrow down”

program wireless on and wireless off. The wireless function is on. The function is off.

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key to stands for

stands for wireless

6. Audio signals NO 1

Name

LCD Display

Power on

Sound

Display LCD syllabus

Control

Beep for 2 seconds

with backlight on.

Power On/Off button for 1 seconds

2

Pulse search

The icon

---

flickers

---

once every second 3

Max./Min.

SpO2

warning

and yellow

Beep-beep

backlight flickers once

repeatedly.

every second

Mute for 2 minutes, then,

or

sounded

beep-beep

Default

Mode

sounded

repeatedly. Mute before power off Mode 4

Max./Min. pulse rate warning

and yellow

Beep-beep

backlight flickers once

repeatedly.

every second

Mute for 2 minutes, then,

or

sounded

beep-beep

Default

Mode

sounded

repeatedly. Mute before power off Mode 5

Probe failure alert

yellow

Beep-beep

backlight Flickers once

repeatedly.

and

sounded

None

every second 6

7

Low battery alert

Heartbeat

yellow

Beep-beep-beep sounded

backlight Flickers once

in cycle for 1 minute and

every second

then power off.

Pulse strength relies on

Mute

and

the

frequency

Battery power

Mode

of

heartbeat

According to heartbeat Other than

8

On/Off button

---

Mute

Press On/Off button for 2 seconds

9

Alarm Off

Appears on the screen and flickers once every second

18

---

Press seconds

for 2

10

Alarm pause

---

Press

---

Press seconds

---

Press

Appears on the screen 11

Max. SpO2 setup

appears on the screen and SpO2 value

flickers

for 2

once

every second 12

Min. SpO2 setup

appears on thescreen and SpO2 value

flickers

for 2

seconds

once

every second 13

Max. Pulse rate setup

---

appears on the

Press

screen and pulse rate value

flickers

once

for 2

seconds

every second 14

Min. Pulse rate setup

---

appears on the screen and pulse rate

Press

for 2

value flickers once

seconds

every second 15

Sound volume

Mute or

Mode

flickers

once every second

Sound volume is signaled with a beep for 1 second

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Sudden drop of SpO2

No change

Beep-beep sounded and

(2% SpO2 drop alert)

Other than Default

stop No change

Mute for 2 minutes, then, Beep-beep sounded and

Mode

off No change

Mute before power off Mode

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Default preview

The

Max.

value

of

SpO2, then the Min. value of SpO2, the Max. value of pulse rate, the Min. value of pulse rate and the memory interval mode (default value of 5 minutes for SA120 and 19

None

Press