IChoice OX200 User Manual

Wireless Fingertip Pulse Oximeter

USER MANUAL

General Description
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO
(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 fingertip 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 (HbO
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 red and 905nm 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
Precautions For Use
1. Before use, carefully read the manual.
2. Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
3. The fingertip pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO
that nothing is hindering the pulse measurement before relying on the SpO
4. Do not use the fingertip pulse oximeter in an MRI or CT environment.
5. Do not use the fingertip pulse oximeter in situations where alarms are required. The device has an audible information
signal that will start when the %SpO2 level falls below 90%.
6. Do not use the fingertip pulse oximeter in an explosive atmosphere.
7. 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.
8. In order to ensure correct sensor alignment and skin integrity, the maximum application time at a single site for our device
should be less than half an hour.
9. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not
intended for sterilization.
10. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components,
including batteries.
11. 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.
12. Portable and mobile RF communications equipment can affect medical electrical equipment.
13. This equipment is not intended for use during patient transport outside the healthcare facility.
14. This equipment should not be used adjacent to or stacked with other equipment.
15. It may be unsafe to：
—use accessories, detachable parts and materials not described in the instructions for use
—interconnect this equipment with other equipment not described in the instructions for use
—disassemble, repair or modify the equipment.
16. These materials that contact with the patient's skin contain medical silicone and ABS plastic enclosure are all pass the
ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
17. The patient is an intended operator. All functions of the device that the patient can safely use.
18. Keep the oximeter away from young children and pet.
Rx only: "Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner."
Contraindication
It is not for continuous monitoring.
Inaccurate measurements may be caused by
1. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin).
2. Intravascular dyes such as indocyanine green or methylene blue.
3. High ambient light. Shield the sensor area if necessary.
4. Excessive patient movement.
5. High-frequency electrosurgical interference and defibrillators.
6. Venous pulsations.
7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9. The patient is in cardiac arrest or is in shock.
10. Fingernail polish or false fingernails.
11. Weak pulse quality (low perfusion).
12. Low hemoglobin.
Product Features
1. Simple to operate and convenient to carry.
2. Small volume, light weight and low power consumption.
3. High brightness LED display SpO .
2
4. Automatically power on/off.
5. 250mAH lithium battery; real-time battery status indication.
6. Wireless Bluetooth for data transmission.
7. Weak or unstable signal prompt provides more accurate measurements.
8. When no signal or low signal is detected, the pulse oximeter will power off automatically in 8 seconds.
9. Compatible with iChoicelife App.
Intended Use
Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin
(SpO ) and pulse rate of adult and pediatric patients in hospitals, hospital-type facilities and homecare
2
Operation Instructions
1. Download the APP from http:// www. Ichoicelife.com and connect the device following these steps: click tap to add devices
–click iChocie OX210(Wireless Fingertip Oximeter) --Add to My Devices -- add device successfully.
2. Place one of your fingers into the rubber opening of the Pulse Oximeter. The device will turn on automatically
3. Keep your hands still for the reading. Do not shake your finger during the test. It is recommended that you do not move your
body while taking a reading.
4. When the Bluetooth icon stop flashing and the reading starts to flash, it means the data has been uploaded to the App
successfully.
5. Read the data from the display screen or from the main page of the iChoice App on your Smartphone.
6. When you plug out your finger, the Pulse Oximeter will power off automatically in 8 seconds.
NOTE:
The measurement data cannot be stored in the device, if the Bluetooth connection is not available for any reasons, the
measurement will be lost, or you can enter the measurement to the App manually.
) capacity, compounded with oxygen, by all combinative hemoglobin
2
) in red and near-infrared zones.
2
measurement. Verify
2
measurement.
2
Know your device
NOTE:
1. The measurement results of PR are displayed iChoicelife App
2. If the screen display "?", it means the signal is unstable, please keep your hands still and retry.
Battery Charge
1. The device adopts the lithium battery (250mAH), the battery can support 2h of continue measuring or more than 400
measurements.
2. Charging time is less than 2h.
NOTE:
1. The battery indicator symbol will flash when the battery voltage is too low for normal operation of the Pulse Oximeter. Please
charge the battery when indicator symbol flash.
2. Use the USB charge cable or the adapter to charge the battery.
3. Make sure the adapter's output voltage is DC5V and the output current is ≤1000mA
Warnings!
1. Keep the oximeter away from young children. Small items such as the USB charge cable are choking hazards.
2. If the device is charging, please do not take measurement.
Maintenance and Storage
1. Charge the battery in a timely manner when battery indicator symbol flash.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for patients.
3. It is best to store the product in -25℃～+70℃ and ≤93% humidity.
4. Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage.
5. 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 being tested finger 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.
The Wireless fingertip pulse oximeter requires no routine calibration or maintenance other than replacement of batteries.
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.
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 accuracy. The measured arterial hemoglobin saturation value (SpO
2
oxygen (SaO ) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to
2
the CO-oximeter samples measured over the SpO range of 70%~100%. Accuracy data is calculated using the root-mean-squared
2
(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.
A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the specified calibration curve and
the PR accuracy.
The model of functional tester is Index2 FLUKE simulator and the version is 2.1.3.
Specifications
1. Display Type
LED display
2. SpO
2
Display range: 35%~99%
Measurement range: 70%~99%
Accuracy: 70%~99%: ±2%; 0%~69% no definition
Resolution: 1%
A Value Analysis
RMS
Item 70--100
#pts 231
Bias 0.03
A 1.07
RMS
Bland-Altman plot analysis of sampled data points on all subjects as below
3. Pulse Rate
Display range: 30bpm~250bpm
Measure range: 30bpm ~250bpm
Accuracy: 30bpm ~99bpm, ±2bpm; 100bpm ~250bpm, ±2%
Resolution: 1bpm
Note: The measurement results of PR are displayed iChoicelife App.
4. Probe LED Specifications
Wavelength Radiant Power
RED 660±3nm 3.2mW
IR 905±10nm 2.4mW
NOTE: The information about wavelength range can be especially useful to clinicians.
5. Power Requirements
Lithium battery (250mAH) for power supply
Battery Life: One250mAH, 3.7V Lithium battery could be continuously operated as long as 2 hours.
Input voltage：AC100V~240V
Input frequency：50Hz~60Hz
Output voltage：DC5V
Output current：1000mA（MAX）
6. Environment Requirements
Operation Temperature: 5℃～40℃
Storage/ Transport Temperature: -25℃～+70℃
Ambient Humidity: 15%～93% no condensation in operation; ≤93% no condensation in storage/transport
Atmosphere pressure: 70kPa～106kPa
7. Equipment data update period
As shown in the following figure. Data update period of slower average is 8s.
) of the sensors is compared to arterial hemoglobin
2
90--100 80--<90 70--<80
82 89 60
-0.06 0.07 0.12
0.92 1.13 1.18