User guide for the MD300 C22 Fingertip Pulse Oximeter

MD300 C22 Pulse Oximeter User Manual

General Description

Oxygen saturation represents the percentage of oxygenated hemoglobin (HbO2) relative to total hemoglobin (Hb) in the blood. In other words, it is the concentration of oxyhemoglobin in the blood. This is an important respiratory system parameter. Many respiratory conditions can result from decreased blood oxygen saturation. Additionally, factors such as anesthesia, extensive postoperative trauma, complications from medical interventions, etc., can also reduce oxygen saturation, leading to dizziness, weakness, vomiting, and even life-threatening conditions. Therefore, it is clinically essential to monitor hemoglobin oxygen saturation so physicians can identify problems in a timely manner.

The fingertip pulse oximeter is small, energy-efficient, easy to use, and portable. For diagnosis, the patient simply inserts a finger into the photoelectric sensor, and the screen immediately displays the oxygen saturation measurement. Clinical studies confirm the high accuracy of this method.

Measurement Principle

The principle is based on the Lambert–Beer law applied to the absorption spectra of reduced hemoglobin (RHb) and oxyhemoglobin (O2Hb) in the visible and near-infrared regions. The device uses photoelectric monitoring technology to scan pulse activity and record results. Two beams of light with different wavelengths (660 nm in the visible range and 940 nm in the near-infrared range) are focused on the fingernail bed via the clip sensor. The transmitted signal is detected by a photosensitive element, processed by electronic circuits and a microprocessor, and displayed by the LEDs as two sets of readings.

Schematic Illustrating Measurement Principle

1. Tube emitting red and infrared light.
2. Tube receiving red and infrared light.

Precautions

1. Do not use the device with MRI or CT equipment.
2. Do not use the device in situations requiring alarm signals. The oximeter does not provide alarms.
3. Do not use in explosive environments.
4. The oximeter is only an auxiliary diagnostic tool and must be used in conjunction with other clinical assessments.
5. Periodically check the sensor element to ensure correct placement considering blood circulation and skin sensitivity.
6. Do not use adhesive tape to secure the sensor; this may cause inaccurate readings or skin issues.
7. Read the manual carefully before use.
8. The oximeter is not equipped with SpO2 alarm functions and is not intended for continuous monitoring.
9. During prolonged testing, change the finger used every 4 hours, checking skin condition and circulation.
10. Do not autoclave, sterilize with ethylene oxide, or immerse in liquid, as this may cause inaccurate readings.
11. Significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or methemoglobin) are not acceptable.
12. Intravascular dyes (e.g., indocyanine green or methylene blue) may affect accuracy.
13. High external lighting can interfere with SpO2 measurement. Shield the sensor from direct sunlight if necessary.
14. Excessive patient movement must be avoided.
15. Prevent interference from high-frequency devices (e.g., electrosurgical tools, defibrillators).
16. Venous pulsations are not acceptable.
17. Do not place the sensor on the same limb with a blood pressure cuff or vascular catheter.
18. Do not use in cases of hypotension, severe vasoconstriction, anemia, or hypothermia.
19. Do not use on patients in cardiac arrest or shock.
20. Readings may be inaccurate with polished or artificial nails.

For disposal or reuse of the device or components, including batteries, follow applicable local regulations.

Key Features

1. Simple and convenient operation.
2. Compact size and lightweight (approx. 50 g including batteries).
3. Low power consumption; two AAA batteries provide up to 30 hours of continuous use.
4. Low voltage warning appears on the display.
5. Automatic shutdown after 8 seconds without signal.

Scope of Application

The fingertip pulse oximeter measures blood oxygen saturation and pulse rate.
It is suitable for home use, hospitals, therapy, surgery, anesthesia, pediatrics, intensive care, and public medical organizations, as well as for check-ups and before or after sports. Use during exercise is not recommended. The device is not intended for continuous monitoring.

Operating Instructions

1. Insert two AAA batteries into the compartment and close the cover.
2. Open the clip as shown in the diagram.
3. Insert a finger fully into the slot and release the clip.
4. Press the “start” button on the front panel.
5. Keep the finger steady and the patient’s body still during operation.
6. Read the displayed values.
7. Six display modes are available.

Each press of the “start” button switches to the next display mode. There are six modes in total, as shown below:

Insert the finger into the pulse oximeter with the nail facing upward!

Note:
Clean the rubber surface inside the oximeter and the finger itself with medical alcohol before and after each test. (The rubber surface inside the oximeter is non-toxic and does not cause allergies or other side effects).

When the finger is placed in the pulse oximeter, the nail surface must face upward. This ensures that the displayed pulse rate histogram corresponds to the actual pulse rate.

Front Panel Overview

Package Contents

1. One lanyard
2. Two batteries
3. One user manual

Battery Installation

1. Insert two AAA batteries, observing polarity.
2. Slide the battery compartment cover horizontally along the arrow, as shown in the diagram.

Note: Strictly observe the correct polarity when installing the batteries. Otherwise, this may cause device damage. Install and remove the batteries in the proper order to avoid damaging the housing. If the device will not be used for an extended period, remove the batteries.

Lanyard Installation

1. Thread the thin end of the lanyard through the lanyard hole.
2. Pass the thick end through the loop and pull tight.

Maintenance and Storage

1. Replace the batteries promptly when the low battery indicator appears.
2. Clean the finger slot surface before each patient test.
3. If the device will not be used for an extended period, remove the batteries.
4. Optimal storage conditions: ambient temperature –10 °C to +40 °C (14 °F to 104 °F) and relative humidity 10% to 80%.
5. Always store the device in a dry environment. Moisture may shorten its lifespan or cause damage.
6. Follow local regulations regarding disposal of used batteries.

Pulse Oximeter Calibration

1. Accuracy cannot be verified using a functional tester alone.
2. The "Index 2" functional tester (Bioteck) can be used. Set parameter “Tech” to 1 and curve R to 2; the user can apply this calibration curve to check the oximeter.
3. The accuracy of SpO2 measurement is established via clinical testing. Pulse oximeter readings are compared to arterial blood samples analyzed by CO-oximeter.

Electromagnetic Compatibility Declaration

The electromagnetic compatibility of this device complies with IEC60601-1-1-2 standards. Materials in contact with the user are non-toxic and biocompatible, according to ISO10993-1, -5, -10 standards.

Technical Specifications of the Pulse Oximeter

1. Display type: LCD
2. SpO2:
Measurement range: 70% – 99%
Accuracy: ±2% for 80%–99%; ±3% for 70%–80%
3. Pulse Rate:
Measurement range: 30 – 235 bpm
Accuracy: ±2 bpm or ±2%, whichever is greater
Pulse intensity: Histogram as indicator
4. Power requirements:
Two AAA alkaline batteries
Power consumption: < 40 mA
Low battery indicator
Battery life:
Two 1.5 V AAA batteries (600 mAh) provide up to 30 hours of continuous use.
5. Dimensions:
Length: 60 mm
Width: 34 mm
Height: 30 mm
Weight: 50 g (including two AAA batteries)
6. Environmental requirements:
Operating temperature: 5 °C – 40 °C
Storage temperature: –10 °C – 40 °C
Operating humidity: 15% – 80%
Storage humidity: 10% – 80%
7. Electromagnetic compatibility: compliant with IEC60601-1-1-2
8. Low perfusion measurement: functional tester “INDEX” (Bioteck) ensures uninterrupted pulse wave simulation at ~6% amplitude.
9. Noise and ambient light immunity: Device operates normally under interference from Bioteck INDEX pulse oximeter simulator.

Electromagnetic Radiation Guidelines and Descriptions

Manufacturer’s guidelines and declarations regarding electromagnetic radiation exposure are provided for all equipment and systems.

Possible Problems and Solutions

Symbols and Their Meaning

	Type BF equipment (equipment with additional protection against leakage currents through the patient)		Heart rate (beats per minute)
	Read the user manual before operation		Battery charge indicator
	Oxygen saturation of hemoglobin		Serial number

Manufacturer

Beijing Choice Electronic Technology Co., Ltd.
Bailangyuan Building B1126-1128, Fuxing Road A36, Beijing 100039 P.R. China
Tel.: +86 10 88203520

Warranty

The warranty period is 12 months from the date the product is put into operation, provided the user follows the conditions of use, transportation, and storage set out in this manual.
Storage warranty period: 6 months.
If no entry about commissioning is made in the manual, the warranty period is counted from the manufacturing date, but not exceeding 18 months.
During the warranty period, malfunctions caused by manufacturer’s fault will be repaired at their expense.