Conrad Electronic OX-97 Tactile Pressure Sensor Pulse Oximeter User Manual

Conrad Electronic OX-97 Tactile Pressure Sensor Pulse Oximeter

Product Information

Specifications

• Display mode: OLED display
• Power supply: DC 3V, 2*1.5V LR03(AAA)
• Auto power off: Switch off after 15 seconds finger out
• Light Source : Red Light, Infrared Light
• Oxygen Saturation (SpO2) Wave Length : 660nm
• Pulse Rate (PRbpm)

Product Usage Instructions

Intended Use
The Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for use in adult patients in clinical institutions and home environments.

Intended Patient Population and Use Site
The device is intended to be used on the fingers of adults older than 18 years old and weighing more than 40kg.

Intended Users
Medical staff and lay persons who meet the following criteria:

1. At least 18 years old with 9 years of intensive reading experience (school).
2. Can read and understand ‘Westernized Arabic’ numerals and distinguish mouth, nose, ear, finger, arm.
3. Can read and understand the instructions for use.

Contraindications
The device is contraindicated for individuals with Attention Deficit Hyperactivity Disorder (ADHD) and those with severe infection or injury at the measurement site.

Intended Use Environment
The intended use environment includes clinical institutions and home settings. The device can be used indoors or outdoors in public places, as long as altitude does not exceed 3000m.

Introduction

Oxygen saturation is the percentage of oxyhemoglobin (HbO2) that is combined with oxygen against all combinable hemoglobin (Hb). It is an important physiological parameter involved in respiration and circulation. The oxygen saturation of arterial blood in a normal human body is 98%. Oxygen saturation is an important indicator of the oxygen condition in the human body. In general, the normal values of oxygen saturation shall not be lower than 94%. If the measured value of oxygen saturation is lower than 94%, an insufficient supply of oxygen is considered.
The pulse rate is the number of pulse beats per minute. Normally, the pulse rate is consistent with the heart rate. In general, the pulse rate of every people is 60 to 90 beats per minute.

1. Intended use/Intended purpose

   • The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate (PR).
   • This portable device is indicated for use in adult patients in clinical institution and home environments.

2. Intended patient population and intended use site
   The device is intended to be measured on the fingers of adults older than 18 years old and weighting more than 40Kg.

3. Intended users
   Medical staff and lay persons are as follows:

4. Who is at least 18 years old with 9 years intensive reading experience (school)

5. Who can read and understand ‘westernized Arabic’ numerals and distinguish mouth, nose, ear, finger, arm

6. Who can read and understand the instructions for use

7. Contraindications
   The subject device is contraindicated for the following conditions:

8. Attention Deficit Hyperactivity Disorder(ADHD).

9. Those with severe infection or injury at the measurement site.

10. Intended use environment
    The intended use environment is defined as follows:

11. Clinical institutions and home,

12. Frequency of use is not limited

13. The subject with no-motion,

14. The subject is in an indoor or outside room or public place, 5)Altitude is not more than 3000m.

Precautions

• Do not attempt to maintain the 0ximeter unless you are professional engineers.0nly professionals with maintenance qualificationare allowed to perform
  interior maintenance necessary.

• Periodically change the contact position between the 0ximeter probe and the finger for a measurement that lasts a long time. Adjustthe position of the probe before the measurement lasts two hours, and check the integrity of skin, the blood circulation condition ofthe finger as well as the position of the finger.

• This product is not applicable to the examination of newborn babies.

• Seek for medical care in time if the measured value goes beyond the normal
  range while you are sure that the instrument does not malfunction.

• Do not directly expose your eyes to light-emitting components of the 0ximeter, as that could cause harm to your eyes

• For details about clinical limitations and contraindications, please carefully consult relevant medical literatures.

• The oximeter needs to wait 20 minutes before trying it out from outdoors to indoors.

• Avoid placing the device in direct sunlight, poorly ventilated places, or heat source accessories such as heaters.

• The accessory battery can work continuously for 12 hours. Please replace the battery in time when the oximeter displays a low battervprompt. 5

• ln the process of use, if the device signal is incomplete, display “–” to indicate.

The following factors may interfere or affect the accuracy of the inspection:

• This product is not suitable for environments involving high-frequency equipment, such as high-frequency electric knife, CT equipment, etc.
• The oximeter probe is placed in the same body part or limb as the blood pressure cuff arterial catheter or intravenous injection.
• The user suffers from hypotension, severe vascular atrophy, severe anemia or hypoxia.
• The user is in a state of cardiac arrest or shock.
• Fingers with nail polish or false nails may cause incorrect pulse oximetry readings.
• The sensor and electrode are degraded or the electrode is loose.

WARNINGS

• Do not use the oximeter in an environment with any flammable gases, flammable anesthetic, or other flammable substances.
• Keep unit and lanyard away from children as the included lanyard may present an entanglement or choking hazard to small children. Adult supervision required; never leave children unattended with unit or lanyard.
• Do not throw the batteries into fire. as that could cause an explosion.
• Do not attempt to charge the included batteries, as that could cause leakage, fire disaster, or even explosion. Dispose the usedbatteries in accordance to the local laws and regulations.
• Do not use the oximeter in an MR or CT environment.
• This product is not used for anesthesia, ICU intensive care or first aid.
• Caution: Do not operate the oximeter if it is wet. Avoid moving the oximeter from a cold to a hot and humid environment.
• Install the batteries properly before powering on the oximeter for normal use. Please remove the batteries if you are not planning touse the oximeter for a long time.
• Close the battery cover when the instrument is in use.
• The patient is an intended operator.
• Do not modify the device and use the device for other purposes.
• This product is calibrated to show functional oxygen saturation. Functional testers cannot be used to evaluate the accuracy of pulse oxygen.
• Long-term use may cause finger ischemia. lt recommended to use within 60 seconds.
• Maintenance and related processing are not allowed during use.
• The battery cover cannot be opened during the measurement.
• This equipment is calibrated and maintained by professional and technical personnel.
• After normalization processing. the pulse waveform tends to be smooth and stable. and the measured value read is the best value.
• This device has no alarm function, can not be used as alarm eguipment, can not be continuous monitoring.
• If the user is allergic, please reduce the use of the product; if the case is serious, please timely seek medical advice.
• This product is not used for pediatric patients.
• This product is not used for poorly perfused.
• This product is not used for sports conditions.
• Notice: The user and/or patient should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Technical Specifications

Light Source| Wave Length| Radiant Power
Red Light| 660nm| < 11mW
Infrared Light| 940nm| < 4mW
__

__

Oxygen Saturation (Sp0 2 )

| Display Range| 35%–100%
Precision| ±2% (80% to 100%);

±3% (70% to 79%):

< 70%, No requirement

Resolution| 1%
Pulse Rate (PRbpm)| Measurement

Range

| 25bpm to 250bpm
Measurement precision| ±2bpm or ±2 %,

Whichever i s greater

Resolution| 1bpm
Remind
Oxygen Saturation (Sp0 2 )| 50%-100% Adiustable, Default:

Upper limit 100%, Lower limit 94%

Pulse Rate (PRbpm)| 25bpm-250bpm Adiustable. Default: Upper limit 130bpm Lower limit 50bpm
Alarm Mode| The value flash and beeping
Service life| 2 years
Operating environment

conditions

| 5°C~40°C; 15%~90%RH non-condensing;

70kPa~106kPa

Environmental conditions for Transportation and Storage| -10 to 60°C;15% to 90%RH non-condensing: 70kPa to 106kPa
Data Processing Time| Display after 6s
Verification| Use the simulator to give different data within the specified range for testing
Clinical benefit| Provide SpO 2 values for doctors to use as a reference to diagnose hypoxia.

Appearance of the Structure

1. Screen Display
2. Power 0N/Function Button
3. Battery Cover

Screen Display

1. Measured value of oxygen saturation
2. Symbol of Oxygen saturation
3. Battery display
4. Symbol of pulse rate
5. Pulse rate bargraph display
6. Measured value of pulse rate

How to Use

Stick one finger completely into the measuring parts of the 0ximeter, keep the fingernail surface upward, and release the clip.

• lf you do not yet completely insert your finger into the cavity, the measurement result may be inaccurate.
• Do not vibrate your finger during measurement, preferably, ensure that your body does not move.
• NOTE: The oximeter will automatically shut down 15 seconds later after your finger leaves away.

Function Description

In the Power on state, press and hold the function key (b) to enter the function adjustment mode, and the corresponding function menu is as follows.

Menu

Remind Setup| Long press to switch menu
Sound Reminder| Long press to switch on or off, default is on
Beep| Long press to switch on or off. default is off
Demo| Lng press to switch on or off, default is off
Restore| Long press to restore
Brightness| 1-5 adiustable
Exit| Long press to exit

Replace the Batteries

• Replace the batteries when the battery capacity is insufficient and the symbol ” battery ” flickers on the screen
• Open the battery cover with your fingers, you can replace the batteries according to the correct battery polarity.

Problem Solution

Spo 2 or pulse rate instability

| The fingers are shaking or the body is moving| Please measure in a calm state
The finger position is deviated| Insert your finger correctly and retest

Unable to start

| The battery is not installed correctly| Reinstall the battery correctly
Low battery| Replace with new battery
Damage to the machine| Please contact sale

Show Finger 0ut

| Finger falls off| Put vour finger into them to re-test
internal component failure| Please contact sale

Graphic Symbol Description

Cleaning and Maintenance

Cleaning

| Use a cotton swab slightly moistened with Ethanol 96% to clean the surface of the window during 15s and immediately wipe dry with a clean cotton swab during 20s.| ****

Clean in time when there is dirt (at least twice a week is recommended).

Gently wipe the display screen and the outside of the pulse oximeter with a soft cloth slightly moistened with Ethanol 96% during 30s, gently wipe the silicone finger mold of the pulse oximeter with a soft cloth slightly moistened with Ethanol 96% during 20s, and immediately wipe dry with a clean cotton swab during 30s.

Disinfection

| Use a cotton swab slightly moistened with 75% medical alcohol to disinfect the window display and exterior during 20s and immediately wipe dry with a clean cotton swab during 25s.| ****

lt is recommended to disinfect after each use.

Gently wipe the outside of the pulse oximeter with a soft cloth slightly moistened with 75% medical alcohol during 20s and immediately wipe dry with a clean soft cloth during 40s.

CAUTION:

• Avoid liquid flowing into the instrument during cleaning.
• Do not immerse any part of the instrument into any liquid.
• Do not disinfect the instrument by means of high-temperature /high-pressure or gas disinfection.

Maintenance

• Remove the batteries from the battery slot and properly store them if you do not plan to use the oximeter for a long period of time.
• Avoid using the oximeter in an environment with inflammable gases or using it in an environment where the temperature or humidityis excessively high or low.
• Check the accuracy of the oxygen saturation and pulse rate readings by using an appropriate calibration apparatus.

EMC Declaration

• The pulse oximeter complies with the electromagnetic compatibility requirements of lEC 60601-1-2.
• Users need to install and use according to the electromagnetic compatibility information provided.
• Portable and mobile radio frequency communication equipment may affect performance, so the pulse oximeter should be kept away from them during use.
• Guidance and manufacturer’s declaration in the following table.

WARNING : The pulse oximeter should not be used adjacent to or stacked with
other equipment. If it needs to be used adjacent orstacked, the pulse oximeter should be observed to verify its normal operation in the use configuration.

Manufacturer’s EMC statement

Guidelines and manufacturer’s declaration-electromagnetic radiation
Pulse oximeter applicable to the following electromagnetic environment. Pulse oximeter customers or users should be sure to use in this environment.

Radiation| In line with| Electromagnetic Environment Guidance
---|---|---
__

RF Transmitter CISPR 11

| __

Group 1

| Pulse oximeter RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment.
RF Transmitter CISPR 11| Type B| __

The pulse oximeter applicable to domestic and facilities directly connected to low-voltage supply network facilities, low-voltage power supply network for the home building.

Harmonic emission IEC 61000-3-2| Not applicable
Voltage fluctuation/ flicker emission

lEC 61000-3- 3

| __

Not applicable

Guidelines and manufacturer’s declaration-electromagnetic immunity
Pulse oximeter applicable to the following electromagnetic environment. Pulse oximeter customers or users should be sure to use in this environment.

Anti-interference test| IEC 60601 test level| Compliance level| Electromagnetic environment-guide
---|---|---|---
__

__

Electrostatic (dischargeESD) 1EC 61000-4-2

| __

__

±8kV

contact discharge

±2kV,±4kV,

±8kV,±15kV

air discharge

| __

__

__

±8kV contact

±2kV,±4kV,

±8kV,±15kV air

| The floor should be wood, concrete or ceramic tiles. If

the floor is covered with synthetic material, the relative humidity should be at least 30%.

__

__

Electrical fast transient/

burst lEC 61000-4-4

| __

±2kV for power cord

±1kV for input/ output line

| __

__

__

Not applicable

| The power quality of the power supply should be the quality of a typical commercial or hospital environment.
---|---|---|---
__

__

Surge lEC 61000-4-5

| __

± 1kV

line to line

± 2kV

line to ground

| __

__

Not applicable

| The power quality of the power supply should be the quality of a typical commercial or hospital environment
__

__

__

__

__

Power input line voltage dips, short interruptions and voltage variations IEC 61000-4-11

| < 5 % U T ( > 9 5 % in U T

environment) for 0. cycles. 40%U T

(60% in U T

environment) Lasts for 5 cycles.

70%U T

(30%in U T

environment) Lasts for 25 cycles.

< 5 % U T

( > 9 5 % i n U T

environment) Lasts 5 seconds.

| __

__

__

__

__

__

Not applicable

| The quality of utility power should be

the quality of a typical commercial or hospital environment. lf the user of the pulse oximeter needs to continue working during the power interruption, it is recommended that the pulse oximeter be powered by an uninterruptible power supply or battery.

__

__

__

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

| __

__

__

__

30 A/m

| __

__

__

__

30 A/m

| The power frequency magnetic field should be at the characteristic level of a typical location in a typical commercial or hospital environment.
---|---|---|---

Note : UT is the AC power supply voltage before the test level is applied.

Guidance and manufacturer’s declaration-electromagnetic immunity
The pulse oximeter is suitable for the following electromagnetic environment. The customer or user of the pulse oximeter should ensure that it is used in this environment.

Anti-interference test| IEC 60601

test level

| Compliance level| Electromagnetic environment-guide
---|---|---|---
 | __

__

__

__

__

3Vrms 150kHz to 80MHz

|  | Portable and mobile radio frequency communication equipment must be used from any part of the pulse

oximeter (including cables) not to exceed the recommended separation distance calculated based on the eguation for

the transmitter frequency. Recommended separation distance.

to

800MHz

d=2.3 P 800MHz to 27GHz

In the formula, P is the maximum output power rating specified by the transmitter manufacturer, in watts (W). and d is the recommended separation distance. in meters (m). The field strength of the fixed RF transmitter determined by electromagnetic field investigation, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbols:  wifi

 | 6Vrms in ISM bands| Not applicable

10V/m

__

Conducted RE IEC 61000-4- 6

RE radiation IEC 61000-4-3

| 10V/m 80MHz to 2.7GHz

385MHz-

5785MHzRF

wireless communication device

housing port immunity test specification (refer to lEC 60601-1-2:

2014 Table 9)

| 385MHz-

5785MHzRF

wireless

communication device housing port immunity test specification (refer to IEC 60601-1-2: 2014

Table 9)

• 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 from structures, objects and people.

1. The field strenath of fixed transmitters, such as base stations of radio (cellular/cordless) telephones and land mobile radios, amateur radio. AM and FM radio broadcasting, and TV broadcasting cannot be accurately predicted in theory.
   ln order to assess the electromagnetit environment of fixed RF transmiters. An electromaanetic site survey should be considered. If the field strength measured at the location where the pulse oximeter is used exceeds the applicable radio frequency compliance level above. The pulse oximeter should be observed to verify its normal operation. lf abnormal performance is observed, other measures may be required, such as repositioning the pulse oximeter.

2. ln the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m.

Recommended separation distance between portable and mobile radio communications device and a pulse oximeter
Pulse oximeter is used to control the electromagnetic environment interfered by radio frequency radiation.According to the maximum output power of the communication device, the customer or user of this pulse oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radio frequency communication devices transmitters, and the pulse oximeter, as suggested below.

Transmitter rated maximum output power (W)| The frequency of the transmitter spacing distance (m)
---|---
150kHz to 80MHz d=1.2xP 1/2| 80MHz to 800MHz d=1.2xP 1/2| 800MHz to 2,7GHz d=2.3xP 1/2
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23

For transmitters with rated maximum output power not listed above, the recommended separation distance d (unit: meter (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) accordable to the transmitter manufacturer.

1. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
2. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Classification

The degree of application safety in the presence of flammable anesthetic mixtures with air or oxygen or nitrous oxide or oxygen-rich environments.| 0X-97 is not suitable for the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide or an oxygen-rich environment.
Operating mode:| Continuous operation

Clinical SpO 2 Accuracy and pulse rate accuracy

• Subjects
  A total of healthy 12 subjects participated in the study, including 5 females and 7 males. Both male and female subjects have undergone a specific medical health screening that includes chest X-ray, ECG, routine blood check, liver and kidney function, urinalysis,blood coagulation function and HCG (for female subjects).  The age distribution of the healthy subjects is 18~ 46, 7 are aged 20-30, 5 are aged 31-46. These 12 subjects included 3 dark-skinned subjects (African), 3 white-skinned subjects (Caucasian), which are representative of the European population, and 6 Asians. The pigmentation of these subjects covered Type 1 ~ Type 6 of the Fitzpatrick Scale.

• Clinical SpO2 accuracy
  According to ISO 80601-2-61, Annex EE,Guideline for evaluating and documenting SpO2 Accuracy in human subjects. using an Invasive testing method- the SpO2 ACCURACY of PULSE OXIMETER EQUIPMENT is measured by comparing SpO2 readings of the PULSE OXIMETER EQUIPMENT to values of SaO2 determined from arterial specimens analyzed by a COOXIMETER.

• Pulse rate accuracy
  The 4 prototypes were placed in a constant temperature room (ambient temperature was set at 25°C, ambient humidity was set at 50%RH) and stood for 2 hours. 4 points were selected from the PR value of 25~250bmp to verify the test data of the four products and record them.Compare the prototypes with the PR value of the pulse oximeter simulator to verify accuracy. The pulse oximeter simulator used is FLUKE Index-2XLFE.

Warranty lnformation

This product has quality problems caused by non-human factors within one week from the date of sale. The company is responsible for return, replacement, and repair: under normal use and storage conditions, if the product has quality problems within one year fror the date of leaving the factory, the company will repair it free of charge; if the product has quality problems within one year from the date of leaving the factor. the user can follow Send the invoice and warranty card to the comoany s afte-sales service department, office or dealer, and the company wll provide accessories for repairs at a reasonable fee. If the user is unable to provide an invoice, the warranty period should be determined based on the company’s equipment number or the factory date extended by one month.

The following conditions are not covered by the warranty:

• Failure caused by unauthorized disassembly, repair or modification of the product;
• Failure caused by accidental fall during use;
• Damage caused by improper use;
• Failure caused by failure to follow the correct operation manual method;
• Losses caused by unforeseen natural disasters (such as fires, earthquakes, floods, etc.).

Shenzhen Everbest Machinery lndustry Co.,Ltd.

• No.101-501, 19th Building & 21st Building, Baiwangxin Industrial Park, No.1002, Songbai Road, Yangguang Community, Xili Street, Nanshan District, Shenzhen, 518108, Guangdong, P.R. China
• Tel :+86-755-27353188
• www.cem-instruments.com

Lotus NL B.V.

• Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
• E-mail :peter@lotusnl.com

FAQ

Q: Can children use this Pulse Oximeter?
A: No, the device is intended for use on adults older than 18 years old and weighing more than 40kg.

Q: How long does the battery last?
A: The device uses two AAA batteries and has an auto power-off feature after 15 seconds of removing the finger.

References

• CEM华盛昌

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