Drive Medical Health Ox 18710 User Manual

Health Ox

Fingertip Pulse Oximeter Oxymetre de Pouls Digital Oximetro de Pulso Tactil

DRIVE MEDICAL

99 Seaview Blvd

Port Washington, NY 11050

www.drivemedical.com

Item # 18710

English

Drive Health-Ox

Fingertip Pulse Oximeter

1.Measurement principle

The Oximeter displays functional oxygen saturation. The oximeter’s algorithm uses the Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (O2 Hb) in glow and near-infrared zones. Operation principle of the instrument is 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 880nm near infrared light) can be focused onto human nail tip through perspective clamp ﬁ nger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on two groups of LEDs through process in electronic circuits and microprocessor.

2.Precautions for use

• Operation of 18710 may be affected by the use of an electrosurgical unit (ESU).

• The 18710 must be able to measure the pulse properly to obtain an accurate SpO2

measurement. Verify that nothing is hindering the pulse measurement before replying on the SpO2 measurement.

• Do not use the 18710 in an MRI or CT environment

• Do not use the 18710 in situations where alarms are required. The device has no alarms.

• Explosion hazard: Do not use the 18710 in an explosive atmosphere.

• The 18710 is intended only for non-medical use for healthy people to monitor their pulse

and blood oxygen levels while exercising.

• Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation and skin sensitivity of the user.

• Before use, carefully read the manual.

• The 18710 has no SpO2 alarms, it is not for continuous monitoring, as indicated by the

symbol.

• Prolonged use or the user’s condition may require changing the sensor site

periodically. It is recommended that the sensor should not be applied to the same ﬁnger for over 2 hours.

3. Inaccurate measurements may be caused by

• Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing

the sensors in liquid which may cause inaccurate readings. The device is not intended for sterilization.

• Signi cant levels of dysfunctional hemoglobin’s (such as carbonxy- hemoglobin or met

hemoglobin)

• Intravascular dyes such as indocyanine green or methylene blue

• SpO2 measurements may be adversely affected in the presence of high ambient light.

Shield the sensor area from direct sunlight or indoor lighting.

• Excessive user movement

• High-frequency electrosurgical interference and de brillators

• Venous pulsations

• Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or

intravascular line

• The user has hypotension, severe vasoconstriction, severe anemia, or hypothermia

• The user is in cardiac arrest or is in shock

• Fingernail polish or false  ngernails may cause inaccurate SpO2 readings.

• Follow local ordinances and recycling instructions regarding disposal or recycling of the

device and device components, including batteries.

4. Technical Speciﬁcations

Display Type: LED display

- SpO2 Measurement Range: 0%-99% Accuracy: ±2%; ≤70% no de nition.

- Pulse Range Measurement Range: 30 – 250 bpm, Accuracy: ±2 bpm or±2% (select larger) for Pulse Rate.

Power Requirement: Two AAA 1.5V alkaline batteries

Low Consumption: Less than 25mA

Measurement Accuracy: SpO2 Accuracy: ±2%; ≤70% no de nition

- No de nition of less than 70%

- Pulse rate Accuracy : ±2 bpm or±2% (select larger) for Pulse Rate.

The product will automatically be powered off when no signal is in the product for longer than 5 seconds.

Dimension: Length: 56mm~62mm,

Width: 32mm~38mm ; Weight: 45g~60g (including two AAA batteries)

Environment Requirements: Operation Temperature: 50°F ~ 104°F / 10°C ~ 40°C Storage Temperature: -40°F ~ 140°F / -40°C ~ 60°C

5.Product Properties

5.1 Operation of the product is simple and convenient

5.2 The product is small in volume, light in weight (total weight is about 50g including batteries) and convenient in carrying

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

5.4 Low voltage warning will be indicated in visual window when battery voltage is so low that normal operation of the Oximeter might be inﬂ uenced.

5.5 The product will automatically be powered off when no signal is in the product for longer than 5 seconds.

6. Product Intended Use

Intended Use:

Fingertip Pulse Oximeter 18710 is a portable non-invasive, spot-check, oxygen saturation

of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric users at home or while exercising.Not for continuously monitoring. The 18710 requires no routine calibration or maintenance other than replacement of batteries.

7. Operation Instructions

7.1 Installing two AAA batteries into battery cassette before covering its cover.

7.2 Open the clamp as illustrated in the picture below

7.3 Plug one of ﬁ ngers into rubber hole of the Oximeter (it is best to plug the ﬁ nger thoroughly) before releasing the clamp

7.4 Press the switch button once on front panel.

7.5 Keep your nger and body still while taking measurements.

7.6 Read correspondent datum from display screen.

7.7 One display mode.

Turn on the Oximeter. Each time you press the power switch, the Oximeter will reset the display and restart its measurements.

When your ﬁ nger is plugged into the Oximeter, your nail surface must be upward.

Brief Description of Front Panel

User pulse quality signals are indicated as such by the amplitude of the bar graph. The higher the amplitude, the stronger the pulse signal.

9. Product Accessories

9.1 One Lanyard

9.2 Two batteries

9.3 One instruction manual

9.4 One protective boot

10. Battery Installations

10.1 Put the two AAA batteries into battery cassette in correct polarities.

10.2 Push the battery cover horizontally along the arrow shown as below:

Notes:

Battery polarities must be correctly installed. Otherwise, damage might be caused to device. Please put or remove batteries in right order, or is

likely to damage the device bracket.

Please remove the battery if the Oximeter will not be used for a long time.

11.Hang Lace Installations

11.1 Thread thinner end of the hang lace through the hanging hole.

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

12. Maintenance and Storage

12.1 Replace the batteries timely when low voltage lamp is lighted

12.2 Clean surface of the ﬁ ngertip Oximeter before it is used

12.3 Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time

12.4 It is best to preserve the product in a place where ambient temperatures –40~60°C (- 40~140°F) and humidity is ≤95% It is recommended that the product should be kept in a dry environment. Wet ambient

might affect its lifetime and even might damage the product.

Cleaning the 18710

Clean inside of Oximeter with a soft cloth dampened with 70% isopropyl alcohol. Clean the

test ﬁ nger using alcohol before and after each test. Do not pour or spray and liquids onto the Oximeter. Do not allow any liquid to enter any openings in the device. Allow the Oximeter to dry thoroughly before reusing.

13. Calibrating the 18710

• The functional tester cannot be used to assess the accuracy of the Oximeter.

• The test methods used to establish the SpO2 accuracy is clinical testing. The oximeter

used to measure the arterial hemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from arterial blood sampling with a CO-oximeter.

14. Possible Problems and resolutions

SpO2% or pulse

rate can not be shown normally

SpO2% or pulse rate

is shown unstably

The Monitor can not be powered on

Indication is suddenly off

1. Finger is not plugged correctly

2. User’s SpO2 value is too low to be measured

1. Finger might not be plugged deep enough

2. Excessive user movement

1. No battery or low power of battery

2. Battery might be installed incorrectly

3. The Monitor might be damaged

1. The Oximeter is automatically powered off when no signal is detected longer than 5 seconds

2. The batteries power is too low to work

1. Retry by plugging the ﬁnger

2. There is excessive illumination

3. Measure more times, If you can

make sure about no problem

existing in the product. Please go to a hospital timelyfor exact diagnosis

1. Retry by plugging the ﬁ nger

2. Be calm.

1. Please replace battery

2. Please reinstall the battery

3. Please contact with local customer service centre

1. Normal

2. Replace the battery

Problems Possible Reason Solution

15. Declaration

Guidance and Manufacture’s declaration – electromagnetic emissionsFor all EQUIPMENT and SYSTEMS

Guidance and Manufacture’s declaration - electromagnetic emission

Guidance and Manufacture’s declaration – electromagnetic environment speci ed below. The customer or

the user of the Pulse Oximeter (18710) should assure that it is used in such an environment.

Emission test

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage  uctuations/ icker

emissions IEC 61000-3-2

Compliance

Group 1

Class B

Not Applicable

Electromagnetic Environment – guidance

The pulse Oximeter (18710) uses RF energy

only for very low and is not likely to cause

interference in nearby electronic equipment.

The pulse Oximeter (18710) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply net-

work that supplies buildings used for domestic

purposes.

Guidance and Manufacture’s declaration - electromagnetic immunity

Guidance and Manufacture’s declaration – electromagnetic environment speci ed below. The customer or

the user of the Pulse Oximeter (18710) should assure that it is used in such an environment.

Immunity test

Electrostatic Discharge (ESD) IEC 61000-4-2

Power frequency

(50/60 Hz) magnetic

ﬁ eld IEC 61000-4-8

IEC 60601 test level

+/- 6kV contact +/- 8kV air

3A/m

Compliance Level

+/- 6kV contact +/- 8kV air

3A/m

Guidance and Manufacture’s declaration – electromagnetic immunityFor all EQUIPMENT and SYSTEMS

Electromagnetic Environment – guidance

Floors should be wood, concrete or ceramic tile. If ﬂ oor are covered with synthetic material, the relative humidity

should be at least 30%.

Power frequency magnetic ﬁelds should be at levels characteristics of a typical location in a typical commercial or hospital environment.

Guidance and Manufacture’s declaration - electromagnetic immunity

Guidance and Manufacture’s declaration – electromagnetic environment speci ed below. The customer or

the user of the Pulse Oximeter (18710) should assure that it is used in such an environment.

Immunity test

Radiated RF IEC 61000-4-3

IEC 60601 test level

3 V/m

80 MHz to

2.5 GHz

Compliance Level

3 V/m

Guidance and Manufacture’s declaration – electromagnetic immunityFor all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

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 reﬂ ection structures, objects and people.

Electromagnetic Environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Pulse Oximeter (18710), 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 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 metres (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

80 MHz to 800 MHz

800 MHz to 2.5 GHz

Electromagnetic Environment – guidance

3.5

a Field strengths from  xed transmitters, such as base station 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 ﬁ xed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁ eld strength in the location in which the Pulse Oximeter (18710) should be observed to verify normal operation. If abnormal performance is observed, additional measurements may be necessary, such as reorienting of the relocating the Pulse Oximeter (18710).

b Over the frequency range 150 kHz to 80 MHz,  elds strengths should be less than 3 V/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 Pulse Oximeter (18710)

The Pulse Oximeter (18710) is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter (18710) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter (18710) 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)

Recommended separation distances between

Separation distance according to frequency of transmitter (m)

80 MHz to 800 MHz

800 MHz to 2.5 GHz

3.5

0.01

0.1 1 10 100

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.1167

0.3689

1.1667

3.6893

11.6667

0.2334

0.7378

2.3334

7.3786

23.3334

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Drive Medical Health Ox 18710 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual