1.

4.

Fingertip

Pulse Oximeter

USER MANUAL

Ver2.0C635

SM-230/SM-240

General Description

Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity, compounded with oxygen, by all combinative hemoglobin

(Hb) capacity in blood. In other words, it is consistency of Oxyhemoglobin in blood. It is a very important parameter for the

Respiratory Circulation System. Many respiratory diseases can result in oxygen saturation being lowered in human blood.

Additionally, the following factors can reduce oxygen saturation: Automatic regulation of organ dysfunction caused by Anesthesia,

Intensive Postoperative Trauma, injuries caused by some medical examinations. That situation might result in light-headedness, asthenia, and vomiting. Therefore, it is very important to know the oxygen saturation of a patient so that doctors can find problems in a timely manner.

The fingertip pulse oximeter features low power consumption, convenient operation and portability. Place one fingertipe into the photoelectric sensor for diagnosis, and the pulse rate and oxygen saturation will appear on the display. It has been proven in clinical experiments that it also features high precision and repeatability.

Measurement Principle

Principle of the oximeter is as follows: A mathematical formula is established making use of Lambert Beer Law according to

Spectrum Absorption Characteristics of Reductive hemoglobin(RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones.

Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity

Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 940nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter’s display through process in electronic circuits and microprocessor.

Diagram of Operation Principle

1. Red and Infrared-ray Emission Tube

2. Red and Infrared-ray Receipt Tube

1

2

3

4

5

6

7

8

9

10

11

12

Precautions For Use

Before use, carefully read the manual.

Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU).

The fingertip pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO

2 that nothing is hindering the pulse measurement before relying on the SpO

2

Do not use the fingertip pulse oximeter in an MRI or CT environment.

measurement.

measurement. Verify

Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms. It is not for continuous monitoring.

Do not use the fingertip pulse oximeter in an explosive atmosphere.

The fingertip pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.

Check the pulse oximeter sensor application site every 4 hours to determine the positioning of the sensor and circulation and skin sensitivity of the patient.

Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not intended for sterilization.

Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries.

This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility for medical electrical equipment and/or systems. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device.

Portable and mobile RF communications equipment can affect medical electrical equipment.

Rx only: “Caution: Federal law restricts this device to sale by or on the order of a physician.”

5

6

7

8

1

2

3

4

9

10

11

12

Inaccurate measurements may be caused by

Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin);

Intravascular dyes such as indocyanine green or methylene blue;

High ambient light. Shield the sensor area if necessary;

Excessive patient movement;

High-frequency electrosurgical interference and defibrillators;

Venous pulsations;

Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line;

The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia;

The patient is in cardiac arrest or is in shock;

Fingernail polish or false fingernails;

Weak pulse quality (low perfusion);

Low hemoglobin;

1

2

3

4

5

Product Properties

Operation of the product is simple and convenient.

The product is small in volume, light in weight and convenient to carry..

Power consumption of the product is low and the two AAA batteries can be operated continuously for 30 hours.

A low voltage warning will be indicated when battery voltage is low and normal operation of the oximeter might be influenced.

The product will automatically power off when there is no signal for longer than 8 seconds.

Intended Use

Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin

(SpO

2

) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). It is not for continuous monitoring.

5

6

7

1

2

3

4

Operation Instructions

Install two AAA batteries according to the Battery Installation instructions listed above in the right column

Open the clamp as illustrated in the picture below.

Fully insert one fingertip into the silicone hole of the oximeter before releasing the clap.

Press the switch button once on front panel.

Keep your finger still during measurement.

Read corresponding data from display screen.

Press the button again to toggle between six display modes.

After turning on the Oximeter, each time you press the power switch, the Oximeter will switch to another display mode.

There are 6 display modes shown as follows:

2.

5.

3.

6.

Holding the power switch for longer than one second, will adjust the brightness of the oximeter.

There are 10 levels of brightness.

The default level is level four.

Front Panel

Patient pulse quality signals are indicated by bar graph. The bar is graded as 10 levels, if the strength is level 2 to 3, the pulse signal is inadequate.

Product Accessories

2. Two batteries

3. One instruction manual

Battery Installation

1.

2.

Press the button down on the rear panel and push the battery cover horizontally along the arrow shown in the following picture.

Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the polarities are not matched, damage may be caused to the oximeter.

Notes:

 Install the batteries with the correct polarity. Incorrect placement may cause damage to the bracket.

 Please remove the batteries if the pulse oximeter will not be used for long periods of time.

Using the Lanyard

1.

2.

Thread thinner end of the lanyard through the hanging hole.

Thread thicker end of the lanyard through the threaded end before pulling it tightly.

Warnings!

1. Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.

2. Do not hang the lanyard from the device’s electrical wire.

1.

2.

3.

4.

5.

6.

Maintenance and Storage

Replace the batteries timely when low voltage lamp is lighted.

Clean surface of the fingertip oximeter before it is used in diagnosis for patients.

Remove the batteries if the oximeter is not operated for a long time.

It is best to store the product in -20℃～+55℃ and ≤93% humidity.

Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage.

Dispose of battery properly; follow any applicable local battery disposal laws.

Cleaning the fingertip pulse oximeter

Please use medical alcohol to clean the silicone touching the finger inside of Oximeter with a soft cloth dampened with 70% isopropyl alcohol. Also clean the finger being tested using alcohol before and after each test.

Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device. Allow the oximeter to dry thoroughly before reuse.

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used to establish the SpO

2

accuracy. The measured arterial hemoglobin saturation value (SpO

2 oxygen (SaO

2

) of the sensors is compared to arterial hemoglobin

) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO

2

range of 70 – 100%. Accuracy data is calculated using the root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment–Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.

The use life of the device is five years. when it is used for 15 measurements every day and 10 minutes per one measurement. Stop using and contact local service center if one of the following cases occurs:







An error in the Possible Problems and solutions is displayed on screen.

The oximeter cannot be powered on in any case and not the reasons of battery.

There is a crack on the oximeter or damage on the display resulting readings cannot be identified; the spring is invalid; or the key is unresponsive or unavailable.

Specifications

1. Display Type

OLED display

2. SpO

2

Display range: 0-99%

Measurement range: 70-99%

Accuracy: 70%-99%: ±2%; 0%~69% no definition

Resolution: 1%

3. Pulse Rate

Display range: 0~254BPM

Measure range: 30-235 BPM

Accuracy: 30~99bpm, ±2bpm; 100~235bpm, ±2%

Resolution: 1BPM

4. Probe LED Specifications

RED 660±2nm 1.8mW

IR 940±10nm 2.0mW

5. Power Requirements

Two AAA alkaline Batteries

Power consumption: Less than 30mA

Battery Life: Two AAA 1.5V, 800mAh alkaline batteries could be continuously operated as long as 30 hours.

6. Outline Dimension

Length: 58mm

Width: 32mm

Height: 37mm

Weight: 33g (without batteries)

Note: The dimensions of each device may differ slightly from the size that mentioned above.

7. Environment Requirements

Operation Temperature: 5～40℃

Storage Temperature: -20～+55℃

Ambient Humidity: 15%~80% in operation ≤93% in storage

8. Equipment Response Time

As shown in the right figure.

Response time of slower average is 12.4s.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations, Electromagnetic propagation is affected by absorption and reflection structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SM-230/SM-240 Pulse Oximeter is used exceeds the applicable RF compliance level above, the SM-230/SM-240 Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SM-230/SM-240 Pulse

Oximeter. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEMS - For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the MD300C63 Pulse Oximeter

The SM-230/SM-240 Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SM-230/SM-240 Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the

SM-230/SM-240 Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

Rated maximum output of transmitter (W)

9. Interference Resistance Capacity against Ambient Light

Device works normally when mixed noise produced by BIO-TEK INDEX Pulse Oximeter Tester.

10. Classification

According to the type of protection against electric shock: INTERNALLY POWERED EQUIPMENT;

According to the degree of protection against electric shock: TYPE BF APPLIED PART;

According to the method(s) of sterilization or disinfection recommended by the manufacturer: Equipment with method(s) of sterilization or disinfection recommended by the manufacturer;

According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH

OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE.

According to the degree of protection against ingress of water: IPX1

According to the mode of operation: CONTINUOUS OPERATION

Declaration

1

2

3

Guidance and Manufacturer’s declaration – electromagnetic emissions-For all EQUIPMENT and SYSTEMS

Guidance and Manufacturer’s declaration - electromagnetic emission

The SM-230/SM-240 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of SM-230/SM-240 Pulse Oximeter should assure that it is used in such an environment.

Emission test Compliance

4 RF emissions CISPR 11

5 RF emissions CISPR 11

6 Harmonic emissions IEC 61000-3-2

7

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Group 1

Class B

N/A

N/A

Electromagnetic Environment – guidance

The SM-230/SM-240 Pulse Oximeter uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Guidance and Manufacturer’s declaration – electromagnetic immunity-For all EQUIPMENT and SYSTEMS

Guidance and Manufacturer’s declaration - electromagnetic immunity

The SM-230/SM-240 Pulse Oximeter is intended for use in the electromagnetic environment specified below.

The customer or the user of the SM-230/SM-240 Pulse Oximeter 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

Electrostatic transient / burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

+/- 6kV contact

+/- 8kV air

±2kV for power supply lines

±1kV for input/output lines

± 1 kV differential mode

± 2 kV common mode

< 5 % UT (>95 % dip in

UT) for 0.5 cycle

40 % UT (60 % dip in

UT) for 5 cycles

70 % UT (30 % dip in

UT) for 25 cycles

< 5 % UT (>95 % dip in

UT) for 5 sec

+/- 6kV contact

+/- 8kV air

N/A

N/A

N/A

Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SM-230/SM-240 Pulse Oximeter requires continued operation during power mains interruptions, it is recommended that the

SM-230/SM-240 Pulse Oximeter be powered from an uninterruptible power supply or a battery.

Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8

NOTE UT is the a. c. mains voltage prior to application of the test level.

Power frequency magnetic fields should be at levels

3A/m 3A/m commercial or hospital environment.

Immunity test

IEC 60601 test level

Guidance and Manufacturer’s declaration – electromagnetic immunity –

For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and Manufacturer’s declaration - electromagnetic immunity

The SM-230/SM-240 Pulse Oximeter is intended for use in the electromagnetic environment specified below.

The customer or the user of the SM-230/SM-240 Pulse Oximeter should assure that it is used in such an environment.

Compliance

Level

Electromagnetic Environment – guidance

Conducted 3 Vrms

RF IEC 150 kHz to

61000-4-6 80 MHz

Radiated

RF IEC 80 MHz to

61000-4-3

3 V/m

2.5 GHz

N/A

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the SM-230/SM-240 Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

100 / 12 23

For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Possible Problems and Solutions

SpO

2

Problems

or PR can not be shown normally

SpO

2

or PR is shown unstably

2. Patient’s SpO

Possible reason

1. Finger is not inserted correctly

2

value is too low to be measured

1. Finger might not be inserted deep enough.

2. Excessive patient movement

The oximeter can not be powered on

1. No battery or low power of battery

2. Batteries might be installed incorrectly

3. The oximeter might be damaged

Solution

1. Retry by inserting the finger

2. There is excessive illumination

3. Try some more times. If you can make sure no problem is existing in the product, please go to a hospital timely for exact diagnosis.

1. Retry by inserting the finger

2. Be calmness

1. Please replace batteries

2. Please reinstall the batteries

3. Please contact with local customer service centre

Indication lamps are suddenly off

“Error3” or

“Error4” is displayed on screen

Error 6

“Error7” is displayed on screen

1. The product is automatically powered off when no signal is detected longer than 8 seconds

2. The battery power is too low to work

1. Err 3 means the red emission LED is damaged

2. Err 4 means the infra-red emission LED is damaged

Err 6 means the screen is failure

Err 7 means all the emission LED or reception dioxide is damaged.

1. Normal

2. Replace the batteries

1. Check the red emission LED

2. Check the infra-red emission LED

Change the screen

Check the emission LED and reception dioxide.

Symbol Definitions

Symbol Definition Symbol

Type BF applied part.

Attention, consult accompanying documents.

SN

No SpO

2

Definition

Alarm

Serial No.

Protected against dripping water.

Storage temperature and relative humidity

Low power indication

Symbol Definition

﹪ SpO

2

Date of Manufacture

PR bpm Pulse rate (BPM)

Oxygen saturation

Note: The illustrations used in this manual may differ slightly from the appearance of the actual product.

Manufactured for：IRoams Network

Address：713 W. Duarte Rd #G810

Arcadia, CA 91007 USA

ALL RIGHTS RESERVED

Issue Date: 23/September 2011

800 MHz to 2.5 GHz

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 meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a , should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with following symbol: