Masimo Radius PCG Manual de usuario
Operator's Manual
Radius PCG™
Mainstream Capnograph
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
www.masimo.com 2 Masimo
3JSV
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
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
www.masimo.com 5 Masimo
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.
Este manual sirve para los siguientes modelos
1
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