Oxygen FAQ

Different models of pulse oximeters will look slightly different and may have some variation, but many devices will operate in a similar way. The screen of the device will show a reading of the SpO2, the pulse rate, and often the waveform. 

• If possible, first remove any nail polish and warm the hands if they are cold. 
• Ensure that the probe is connected to the oximeter and that the device is charged. 
• Power on the device, and then clip the probe onto the fingertip while keeping the patient’s hand still.  
• After a few moments, the screen will display the SpO2. 
• If the device shows a pleth, it is important to check that the waveform looks appropriate. 

Many pulse oximeters also have buttons which allow the user to control alarm volume, screen display, and turn the device on and off. Now, the patient can continue to be monitored and checked for signs and symptoms of hypoxemia. It is always important to follow the manufacturer’s instructions for use if these are available. Finally, if the device does not seem to be working, try to troubleshoot the issue.

References: Lifebox Pulse Oximetry Learning Module

Keywords: how to use, instructions

Recent studies using data from 54 countries have shown that about 77,700 operating rooms worldwide do not have pulse oximeters. When accounting for other clinical practice settings such as post-op recovery units and intensive care units, the ‘oximetry gap’ is likely much greater. Barriers to access include cost, supply chain, and incorporation into local practice guidelines.

References: Funk et al, Lancet 2010; Gibbs et al, What is the real oximeter gap?, Anaesthesia, 2017

Keywords: access, operating rooms, equipment

Spectrophotometry is a type of quantitative measurement technique that is used to measure the reflection or transmission properties of a substance as a function of wavelength. Every type of substance absorbs light over a specific range of wavelengths. This type of measurement allows us to assess the intensity of light that a substance (such as hemoglobin in blood) absorbs, and therefore has clinical and bioengineering applications. 

Clinically, spectrophotometry is used in pulse oximeters to determine the proportion of oxygenated hemoglobin in arterial blood. Since different wavelengths of light are absorbed by oxygenated and deoxygenated blood, pulse oximeters can use this technique to determine a patient’s peripheral oxygen saturation (SpO2).

Keywords: spectroscopy, spectrophotometry, wavelength, light

As patient status can change rapidly during anesthesia, a qualified anesthesia provider should be present continuously to monitor the patient and provide anesthetic care. The American Society of Anesthesiologists has determined standards for basic anesthetic monitoring, which state that “during all anesthetics, the patient’s oxygenation, ventilation, circulation and temperature shall be continually evaluated.” 

Regarding blood oxygenation and SpO2 measurement during anesthesia, ASA standards state that “a quantitative method of assessing oxygenation such as pulse oximetry” should be used at all times. It is important that the volume, pitch, and low threshold alarm noises be audible to the anesthesia care team personnel throughout the duration of anesthesia.

References: ASA Monitoring Requirements

Keywords: anesthesia, monitoring, frequency

Pulse oximeters can be used to measure many different clinically important values. Some (but not all) pulse oximeters can measure the following:

• Respiratory rate
• Perfusion
• Carboxyhemoglobin
• Methemoglobin
• Hemoglobin concentration
• Pulsatility variation

Keywords: measurement, respiratory rate, pulsatility variation

To receive FDA approval on a new device intended for human use, a premarket submission called a 510k must be made to the FDA. This must demonstrate that the device is substantially equivalent to a legally marketed device, meaning that it is just as safe and effective.

According to the FDA, a device is considered “substantially equivalent” if the following criteria are met: 

• Has the same intended use as the predicate device; and
• Has the same technological characteristics as the predicate;
  OR
• Has the same intended use as the predicate; and
• Has different technological characteristics and does not raise different questions of safety and effectiveness; and
• The device is demonstrated to be as safe and effective as the legally marketed device

Once this information has been submitted to the FDA, the FDA will determine whether the device is safe and effective through a thorough review process, including evaluation of performance data and technological characteristics. In the US, a device may not be marketed until the FDA determines that substantial equivalence is present.

References: FDA Premarket Notification 510(k)

Keywords: substantially equivalent, SE, FDA, 510k

An IP rating, also known as the ingress protection rating, is the rating of a product’s ability to withstand liquid and dust. IP ratings were defined and developed by the International Electrotechnical Commission (IEC), and are recognized all over the world.

The IP code is composed of two numbers:

• The first number rates the device’s protection against solid particles (i.e. dust). It is rated from 0 (no protection) to 6 (full protection).
• The second number rates the device’s protection against liquids. It is rated from 0 (no protection) to 9 (protection from high-pressure, high-temperature liquid).

References: IEC: IP Ratings

Keywords: IP, ingress protection, dust, liquid, IEC

The International Organization for Standardization (ISO) is a worldwide standard-setting body. It is composed of representatives from several national standards organizations and aims to provide common standards for technology, agriculture, healthcare, and other manufactured products. These standards are meant to ensure that products and services are safe and of good quality.

ISO has standards for various healthcare-related devices and products, including pulse oximeters. ISO 80601-2-61:2017 describes the requirements for basic safety and essential performance of pulse oximeter equipment. This also includes standards for the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.

References: ISO: Pulse Oximeter

Keywords: ISO, international organization for standardization

While SpO2 can be useful in many cases, there are certain situations where an arterial blood gas (ABG) should be drawn and analyzed. If the pulse oximeter shows a tracing that is dampened or erratic, or low PI or signal quality indicator, this may indicate that the SpO2 readings are unreliable and an ABG is warranted. Also, if there are any other factors present that might reduce the pulse oximeter’s accuracy (such as poor perfusion, low body temperature, etc.), an ABG should be obtained. 

Other reasons to get an arterial blood gas include if there is a clinical suspicion of Met-Hb, CO-Hb, S-Hb, or other hemoglobin types. Additionally, pulse oximetry does not provide information about ventilation or acid-base status, so an ABG is needed in situations where this information is also needed.

Keywords: ABG, arterial, blood gas

Key points for sustainability of an oxygen supply system begin with identification of a cost analysis for operational expenses:

• Cost of power to operate 24/7 – include cost of grid power and diesel fuel for back-up generators.
• Cost of spare parts package that is specific for the type of equipment to be installed. For example: key equipment for spare parts includes the air compressor, PSA generator and the booster compressor for filling cylinders (if filling cylinders). Budget for the spare parts and confirm the supply chain to order and import the spare parts.
• Staffing costs of Engineers for service and daily operations.
• Cost of service contracts for outside service provider to do regular maintenance

FAQ by Assist International