Masimo EMMA Manual de usuario

Operator's Manual

EMMA®Capnograph

These operating instructions provide the necessary information for proper operation of all models of the EMMA. 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 EMMA are prerequisites for its proper use. Do not operate EMMA

without completely reading and understanding these instructions.

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.

Masimo Sweden AB

Svärdvägen 15

SE-182 33 Danderyd

Sweden

Telephone: +46 8 544 98

Fax: +46 8 544 98 169

www.masimo.com

3JSV

MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL

HAZARDS ONLY IN ACCORDANCE WITH

ANSI/AAMI ES60601-1 (2005) and CAN/CSA-C22.2 No. 60601-1 (2008)

www.masimo.com 2 Masimo

Patents: www.masimo.com/patents.htm

®, and Masimo® are federally registered trademarks of Masimo Corporation.

EMMA™ and XTP™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property

of their respective owners.

Contents

About this Manual ------------------------------------------------------------------------------------------------------5

Product Description, Features and Intended Use------------------------------------------------------------------- 7

Safety Information, Warnings and Cautions ------------------------------------------------------------------------9

Chapter 1: Technology Overview------------------------------------------------------------------------------------ 13

Chapter 2: Description-------------------------------------------------------------------------------------------------17

Chapter 3: Setting Up ------------------------------------------------------------------------------------------------ 19

Chapter 4: Operation ------------------------------------------------------------------------------------------------- 25

Chapter 5: Alarms and Messages ----------------------------------------------------------------------------------- 35

Chapter 6: Troubleshooting ----------------------------------------------------------------------------------------- 39

Chapter 7: Specifications----------------------------------------------------------------------------------------------41

Chapter 8: Service and Maintenance ------------------------------------------------------------------------------ 53

www.masimo.com 5 Masimo

About this Manual

This manual explains how to set up and use EMMA® Capnograph. Important safety information relating to general

use of EMMA 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.

www.masimo.com 7 Masimo

Product Description, Features and Intended

Use

Product Description

The EMMA® Capnograph is a quantitative mainstream carbon dioxide monitor comprised of a Sensor Body that fits on

top of a disposable EMMA Airway Adapter.

Intended Use

EMMA® Capnograph 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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