Radius PCG Mainstream Capnograph Operators Manual

These operating instructions provide the necessary information for proper operation of all models of the Radius PCG. There may be information provided in this manual that is not relevant for your system. General knowledge of capnography and an understanding of the features and functions of Radius PCG are prerequisites for its proper use. Do not operate Radius PCG without completely reading and understanding these instructions. If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling. Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings and precautions. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. Wireless Radio: Contains: FCC ID: VKF-EMMABT | IC: 7362A-EMMABT | Model: EMMA Bluetooth Masimo Sweden AB Svärdvägen 15 SE-182 33 Danderyd Sweden Telephone: +46 8 544 98 150 Fax: +46 8 544 98 169 www.masimo.com

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MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO. 60601-1:14

Patents: www.masimo.com/patents.htm ®, Masimo®, Radius®, and Root®, are federally registered trademarks of Masimo Corporation. Radius PCG™ and XTP™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. © 2021 Masimo Corporation

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Contents About this Manual --------------------------------------------------------------------------------------------------------- 5 Product Description, Features and Intended Use--------------------------------------------------------------------- 7 Safety Information, Warnings and Cautions -------------------------------------------------------------------------- 9 Chapter 1: Technology Overview -------------------------------------------------------------------------------------- 15 Chapter 2: Description -------------------------------------------------------------------------------------------------- 19 Chapter 3: Basic Setup and Use --------------------------------------------------------------------------------------- 21 Chapter 4: Operation ---------------------------------------------------------------------------------------------------- 27 Chapter 5: Alarms and Messages ------------------------------------------------------------------------------------- 37 Chapter 6: Troubleshooting -------------------------------------------------------------------------------------------- 41 Chapter 7: Specifications ----------------------------------------------------------------------------------------------- 43 Chapter 8: Service and Maintenance --------------------------------------------------------------------------------- 57 Appendix A: Operation with Root ------------------------------------------------------------------------------------- 67 Appendix B: Concepts of Alarm Response Delay ------------------------------------------------------------------- 91

About this Manual This manual explains how to set up and use Radius PCG™. Important safety information relating to general use of Radius PCG appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user. WARNING: This is an example of a warning statement. A caution is given when any special care is to be exercised by the patient or user to avoid injury to the patient, damage to this device, or damage to other property. CAUTION: This is an example of a caution statement. A note is given when additional general information is applicable. Note: This is an example of a note.

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Product Description, Features and Intended Use Product Description The Radius PCG™ (model: EMMA Bluetooth) is a quantitative mainstream carbon dioxide monitor comprised of a Sensor Body that fits on top of a disposable EMMA Airway Adapter. The Radius PCG™ includes Bluetooth wireless technology so that data can be transferred to a paired device.

Intended Use Radius PCG™ measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

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Safety Information, Warnings and Cautions CAUTION: Radius PCG is to be operated by, or under the supervision of, qualified personnel only. Read the manual, accessories directions for use, all precautionary information, and specifications before use.

Safety Warnings and Cautions WARNING: Radius PCG should only be used for the purpose and in the manner described in this manual. WARNING: Radius PCG is intended for use by authorized health care professionals only. WARNING: Radius PCG must not be used with flammable anesthetic agents. WARNING: If Radius PCG is used with a respirator or with harmful gases such as N2O, always perform a pre-use tightness check of the patient circuit. WARNING: EMMA Airway Adapters shall not be reused. Reuse of single use Adapters can cause cross infection. WARNING: Do not use the EMMA Adult/Pediatric Airway Adapter with infants as the Adapter adds 6 ml dead space to the patient circuit. WARNING: Do not use the EMMA Infant Airway Adapter with adults/pediatrics as this may cause excessive flow resistance. WARNING: Do not use the Radius PCG during magnetic resonance imaging (MRI) or in an MRI environment.

Performance Warnings and Cautions WARNING: Radius PCG is intended only as an adjunct in patient assessment. It shall be used in conjunction with the assessment of clinical signs and symptoms. WARNING: Use only EMMA Airway Adapters manufactured by Masimo. WARNING: No modification of the Radius PCG probe or the EMMA Airway Adapters is allowed.

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WARNING: Light transmission can be affected by secretions and moisture pooling on the EMMA Airway Adapter XTP™ windows. When using heated humidifiers special care should be paid to position the Airway Adapter in a vertical position and to change Airway Adapter if necessary. WARNING: Do not use Radius PCG with nebulized medications as this may affect the light transmission of the EMMA Airway Adapter windows. WARNING: Audible alarm of any monitor may not be heard in some loud environments, such as when sirens are in use and the care provider is more distant from the alarm source. Alarm volume should be tested with the extremes of your noise environment to confirm ability or limitations to hear an alarm in all circumstances of the environment. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating properly. WARNING: Make sure that Radius PCG is used in the electromagnetic environment specified in this manual. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Radius PCG. Otherwise, degradation of the performance of the Radius PCG could result. WARNING: When used in environments with known sources of RF interference (e.g., diathermy, electrocautery, RFID), avoid close proximity to such devices to minimize the risk of interference that may interrupt the measurement performance. WARNING: Do not use in aircraft environments during take-off, landing, or while on the ground where rotational radars may be more likely to be present. High levels of electromagnetic interference that can be generated by rotational radars may result in no or inaccurate readings. WARNING: When used with a Bluetooth connection to Root, the display and alarms on the Radius PCG should be used as the primary monitoring system. Under significant interference, corruption of Bluetooth communication to the Root can occur. CAUTION: When used in aircraft environments, turn off the Bluetooth radio if not in use to minimize the potential for interference with other surrounding devices. CAUTION: Turn off the Bluetooth radio if you suspect that the communication has been compromised or if not in use to prevent unauthorized access to data and minimize cybersecurity concerns. www.masimo.com

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Note: To preserve and maximize battery life, make sure alarm conditions are addressed promptly and the unit is turned off when not in use, especially prior to storage. Note: Bluetooth functionality is implemented differently by the various connected-device manufacturers and incompatibility between the Radius PCG and your external device may occur. Note: A trained medical professional must determine the proper EMMA Airway Adapter model for each patient application. No hardware or software configuration changes result from the EMMA Airway Adapter model selected. Note: The alarm limits will be reset to default values after Radius PCG powers off.

Cleaning and Service Warnings and Cautions WARNING: Properly use and dispose of batteries or they may leak or explode. WARNING: Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100°C (212°F) or incinerate. Dispose of used cells promptly. Keep away from children. WARNING: Use only Alkaline batteries or Energizer Ultimate Lithium L92 batteries. Use of other Lithium batteries may present a risk of fire or explosion. WARNING: Replace batteries immediately when the Battery Status Indicator starts blinking. Remaining battery time depends on battery type and other circumstances and cannot be reliably predicted. CAUTION: Remove alkaline batteries when the Radius PCG will not be in use for more than 30 days to avoid damage to the device due to batteries that may leak. CAUTION: Replace both batteries at the same time to avoid mixing fully and partially charged batteries. These actions may cause the batteries to leak; resulting in possible damage to the device. CAUTION: Do not immerse Radius PCG in any liquid. CAUTION: Do not apply excessive pressure on the IR-windows. CAUTION: Never saturate Radius PCG completely with any disinfection solution. CAUTION: Only perform maintenance procedures specifically described in the manual; otherwise, return Radius PCG for servicing. Improper maintenance may result in damage to the internal parts. Damage to internal parts may result in no or inaccurate readings. www.masimo.com

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CAUTION: Do not clean Radius PCG with any chemical other than those specified in Maintenance and Cleaning of this manual. These substances may affect the device’s materials and damage internal parts. CAUTION: The Radius PCG device and EMMA Airway Adapters are non-sterile devices. Do not submerge Radius PCG device or EMMA Airway Adapters in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. CAUTION: Do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any cleaning solution other than those recommended in Maintenance and Cleaning of this manual. Permanent damage to Radius PCG may occur if other unspecified solutions are used. CAUTION: Never submerge Radius PCG in water or any other liquid solution. This may cause permanent damage to the Radius PCG. Note: Before cleaning Radius PCG, remove the batteries and make sure the battery cover is re-attached correctly. Note: The presence of ambient air (0% CO2) in the EMMA Airway Adapter is of crucial importance for a successful Zeroing. Special care should be taken to avoid breathing near the Airway Adapter before or during the Zeroing procedure.

Compliance Warnings and Cautions WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. CAUTION: EMMA Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous waste. Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. www.masimo.com

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Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •

Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. Note: This equipment has been tested and found to comply with the Class B limits for medical devices according to the EN 60601-1-2: 2015, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in all establishments, including domestic establishments. Note: This Class B digital apparatus complies with Canadian ICES-003. Note: This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Note: This device has been evaluated for electro compatibility in an aircraft in accordance with RTCA DO-160G, Section 21, Category M emissions and Section 20, Category R immunity. Avoid using the device in environments with or in close proximity to electrical fields higher than 100 V/m in frequency range of 4 GHz and 8 GHz (i.e., rotational radars) to minimize interruptions in performance.

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Chapter 1: Technology Overview The following chapter contains general descriptions about parameters, measurements, and the technology used in Radius PCG.

Principles of Operation The measurement of CO2 in the breathing gas mixture is based on the fact that different gas components absorb infrared light at specific wavelengths. A beam of invisible infrared light is directed through the respiratory gas flow in the EMMA Airway Adapter. As the beam passes through the Airway Adapter, some of the light is absorbed by the gas mixture. The amount of absorbed light is measured by a miniaturized two-channel spectrometer positioned to receive the infrared light beam. The spectrometer incorporates a filter wheel fitted with two different optical "color" filters. The wavelength ranges of these filters are chosen such that one filters out colors where carbon dioxide has very strong absorption and the other filters out colors where carbon dioxide has no absorption. The spectrometer also incorporates an infrared detector that converts the light beam to an electrical signal. The electrical signal is converted to a digital value that is fed to a microprocessor. The ratio of the light measured through the two filters is then used by the microprocessor to calculate the carbon dioxide concentration in the breathing gas mixture.

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1 Spectrometer with optical filter wheel and infrared detector 2 Infrared light beam 3 Infrared light source 4 Respiratory gas

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EMMA Airway Adapter Respiratory gas measurements are, as described in the previous section, obtained by continuously measuring the infrared light absorption through the EMMA Airway Adapter. The Airway Adapter is fitted with optical XTP™ windows that are transparent to light in the wavelength ranges of interest. The Airway Adapter may, for example, be inserted between the endotracheal tube and the resuscitation bag or between the resuscitation bag and the patient mask. The Airway Adapter is available in two models: Adult/Pediatric and Infant. Radius PCG operates to specification with either Airway Adapter model when used with its appropriate patient population. • •

The Airway Adapters are intended for single patient use. They are disposable and shall not be re-used. Reuse of single patient use Adapters can cause cross infection. Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous waste.

EMMA Airway Adapter Adult/Pediatric (REF 100620)

EMMA Airway Adapter Infant (REF 100660)

1. XTP window (Adult/Pediatric)

2. XTP window (Infant)

Note: A trained medical professional must determine the proper EMMA Airway Adapter model for each patient application. No hardware or software configuration changes result from the Airway Adapter model selected.

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Chapter 2: Description This chapter contains the description of the Radius PCG physical features.

General System Description The Radius PCG system includes the following: •

Radius PCG Device

• Two (2) AAA Batteries For a complete list of compatible EMMA Airway Adapters, visit www.masimo.com.

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Features 1 Battery Cover 2 Battery Cover release button 3 Lanyard attachment 4 Alarm Silence button 5 EtCO2 Value 6 Capnogram 7 Power On button 8 EMMA Airway Adapter 9 Alarm Status 10 Respiratory Rate Value 11 Battery Status Indicator 12 Bluetooth Indicator 13 Radius PCG Sensor Body

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Chapter 3: Basic Setup and Use This chapter contains information about setting up Radius PCG before use.

Installing Batteries Unpack and inspect the Radius PCG for external damage. Please contact your local distributor in case of damage. 1. Press the Battery Cover release button into the Radius PCG Sensor Body until the Battery Cover pops off.

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2.

Open the battery compartment and insert two (2) AAA batteries. Make sure the batteries are fitted according to the indicated polarity. After battery installation, snap the Battery Cover back into place.

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Attaching Airway Adapter Snap the EMMA Airway Adapter into the Radius PCG Capnograph. It will click into place when properly inserted.

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Connecting to a Tube or Mask The Radius PCG can be connected to a patient using an endotracheal tube or mask. The following pictures illustrate these two methods of connection. Endotracheal tube

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Mask

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