Masimo EMMABT User Manual
605100, 605102, 655100, 655102
USER’S MANUAL
Important user information
All users must read this entire manual to fully
understand the safe use of EMMA.
Declaration of conformity
0413
Complies with 93/42/EEC Medical Device Directive.
FDA Approval reference number K072813 and
K063167.
Safety notices
This user manual contains Warning notices and
Caution notices. These notices shall be followed.
WARNING! Warnings indicate a potential harmful
condition that can possibly lead to injury or death.
CAUTION! Cautions indicate conditions which may
lead to the damage or malfunction of the device.
NOTE! Alert the user to relevant facts and
conditions.
Liability
Masimo Sweden AB shall in no event be liable for any
direct, indirect, special or consequential damages,
including without limitation, loss of profits, income,
information, or use of the product, business interruption,
other related damages, however caused, arising from
the use of the product described in this manual.
Disclaimer
Masimo Sweden AB guarantees that the product
delivered has been tested to ensure that it meets its
published specifications.
Warranty
Please contact your local distributor for details
regarding warranty and product returns.
Use of the product for other than its intended use, or if it
is repaired by anyone except Masimo Sweden AB or a
Masimo authorized service center, or altered or
modified or used without following the instructions
provided with the product, voids the warranty.
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)
3JSV
Patents
Masimo holds the following patents regarding
products described in this manual: SE519766;
SE519779; SE523461; SE524086. Other patents
pending.
Trademarks
Masimo EMMA and Masimo XTP Windows are
trademarks of Masimo Corporation.
Copyright
This document contains proprietary information
that is protected by copyright. All rights are
reserved. No part of this document may be
photocopied, reproduced or translated to another
language without prior written consent of Masimo
Sweden AB.
All Rights Reserved. © 2017 Masimo Sweden AB
Contact information
Masimo Sweden AB
Svärdvägen 15
SE-182 33 Danderyd
Sweden
Telephone: +46 8 544 98 150
Fax: +46 8 544 98 169
Web site: www.masimo.com
The information in this document is subject to
change without notice.
Article no: 0001-6984
Edition: 02
Released: March 2017
Revision history
Edition Date Description
01 September 30th 2016 Revised for EMMA Capnograph with Bluetooth functionality.
02 March 20th 2017 Ch.2.3: Added statement that EMMA Bluetooth complies with Canada RSS standards.
2 (34)
Contents
1 INTENDED USE .................................................................................................................................. 4
2 SAFETY INFORMATION .................................................................................................................... 5
2.1 WARNINGS ..................................................................................................................................... 5
2.2 CAUTIONS ...................................................................................................................................... 6
2.3 NOTES ........................................................................................................................................... 6
2.4 SYMBOL DESCRIPTION ..................................................................................................................... 8
3 DEVICE DESCRIPTION .................................................................................................................... 10
3.1 EMMA CAPNOGRAPH OVERVIEW................................................................................................... 10
3.2 PRINCIPLE OF OPERATION ............................................................................................................. 11
3.2.1 EMMA Airway Adapter ........................................................................................................ 12
4 PREPARATIONS FOR USE ............................................................................................................. 13
4.1 SETTING UP .................................................................................................................................. 13
4.2 STARTING UP ................................................................................................................................ 14
4.3 SWITCHING OFF ............................................................................................................................ 15
4.4 CONNECTING THE EMMA CAPNOGRAPH TO A TUBE OR A MASK ....................................................... 15
5 USER INTERFACE ........................................................................................................................... 16
5.1 CONTROLS ................................................................................................................................... 16
5.2 BLUETOOTH (OPTIONAL) ................................................................................................................ 16
5.3 MONITORING ................................................................................................................................ 17
5.3.1 ETCO2 ................................................................................................................................. 17
5.3.2 Respiratory Rate ................................................................................................................. 17
5.2.3 Capnogram .......................................................................................................................... 17
5.4 INDICATORS AND ALARMS .............................................................................................................. 18
5.4.1 Alarm signals ....................................................................................................................... 18
5.4.2 Default limits for alarms ....................................................................................................... 19
5.4.3 Alarm silence ....................................................................................................................... 19
5.4.4 Battery Status Indicator ....................................................................................................... 20
5.4.5 Adjusting the ETCO2 alarm limits ........................................................................................ 20
6 EMMA AND ACCESSORIES ............................................................................................................ 22
7 MAINTENANCE AND SERVICE ...................................................................................................... 23
7.1 BATTERY REPLACEMENT ............................................................................................................... 23
7.2 CLEANING .................................................................................................................................... 23
7.3 EMMA AIRWAY ADAPTER ............................................................................................................. 23
7.4 ZEROING PROCEDURE ................................................................................................................... 24
7.5 GAS SPAN CHECK ......................................................................................................................... 24
7.6 TROUBLESHOOTING ...................................................................................................................... 26
7.7 SERVICE AND PRODUCT RETURN REQUIREMENTS ........................................................................... 26
8 TECHNICAL SPECIFICATIONS ....................................................................................................... 27
8.1 GENERAL SPECIFICATIONS ............................................................................................................ 27
8.3 ELECTROMAGNETIC COMPATIBILITY (EMC) .................................................................................... 29
8.4 COMPLIANCE ................................................................................................................................ 33
8.5 BLUETOOTH LE WIRELESS TECHNOLOGY INFORMATION ................................................................. 33
8.6 CLASSIFICATIONS ......................................................................................................................... 33
3 (34)
1 Intended use
EMMA 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.
4 (34)
2 Safety information
Adhere to the following warnings, cautions and notes for safe operation of EMMA.
2.1 Warnings
WARNING! EMMA should only be used for the purpose and in the manner described in this
manual.
WARNING! EMMA is intended for use by authorized health care professionals only.
WARNING! EMMA must not be used with flammable anesthetic agents.
WARNING! Use only EMMA Airway Adapters manufactured by Masimo.
WARNING! No modification of the EMMA probe or the EMMA Airway Adapters is allowed.
WARNING! EMMA Airway Adapters shall not be reused. Reuse of single use Adapters can
cause cross infection. Used Airway Adapters shall be disposed of in accordance with local
regulations for medical waste.
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 as this may cause
excessive flow resistance.
WARNING! Measurements can be affected by mobile phones and RF communications
equipment. It should be assured that EMMA is used in the specified electromagnetic
environment.
WARNING! EMMA is intended only as an adjunct in patient assessment. It shall be used in
conjunction with the assessment of clinical signs and symptoms.
WARNING! If EMMA is used with a respirator or with harmful gases such as N
perform a pre-use tightness check of the patient circuit.
WARNING! Light transmission can be affected by secretions and moisture pooling on the
EMMA Airway Adapter XTP
paid to position the Airway Adapter in a vertical position and to change Airway Adapter if
necessary.
WARNING! Do not use EMMA 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.
TM
windows. When using heated humidifiers special care should be
O, always
2
5 (34)
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.
WARNING! Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not
disassemble, heat above 100C (212F) or incinerate. Dispose of used cell 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.
2.2 Cautions
CAUTION! If EMMA is used in a manner other than that for which it was intended, unpredictable
behavior could result.
CAUTION! The EMMA Airway Adapters are non-sterile devices. Do not autoclave the devices as this
will damage them.
CAUTION! Never sterilize or immerse EMMA in liquid.
CAUTION! Do not operate EMMA at ambient temperatures less than -5°C (23°F) or greater than
50°C (122°F).
CAUTION! Federal law restricts this device to sale by or on the order of a physician.
CAUTION! Remove batteries if EMMA is not likely to be used for a period of time longer than 90 days.
2.3 Notes
NOTE! Throughout this User’s Manual:
EMMA Airway Adapter refers to both Airway Adapter Adult/Pediatric and Airway Adapter Infant if not
otherwise mentioned.
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 power off.
NOTE! Always carry spare batteries in the EMMA pouch.
NOTE! The presence of ambient air (0% CO
for a successful Zeroing. Special care should be taken to avoid breathing near the EMMA Airway
Adapter before or during the Zeroing procedure.
NOTE! EMMA Bluetooth 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.
Changes or modifications not expressly approved by the manufacturer could void the user’s authority
to operate the equipment.
) in the EMMA Airway Adapter is of crucial importance
2
6 (34)
NOTE! EMMA Bluetooth complies with Industry Canada license-exempt RSS standard(s). 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.
7 (34)
2.4 Symbol description
Symbol Title Explanation
Catalog number
Serial number
Batch code
Manufacturer
Use by date [YYYY-MM-DD] Indicates that the device should not be taken into
Temperature limitation
Follow instructions for use This symbol replaces, and has the same meaning,
as the previously used symbol ISO7000-0434.
Defibrillation-proof type BF applied
part
Accompanied by the name and address of the
manufacturer.
operation after the date accompanying the symbol
(EMMA Airway Adapters).
Pressure limitation
Humidity limitation
Do not re-use Intended for single patient use (EMMA Airway
Adapters).
For EU only:
Waste Electrical and Electronic
Equipment (WEEE)
Conformité Européenne Complies with 93/42/EEC Medical Device
0413
UL classification mark Classified by Underwriters Laboratories Inc. for
3JSV
IP33
IP classification indicating degree
of protection against water and
For EU only:
Electrical and electric equipment shall be collected
and recycled in accordance with Directive
2002/96/EC.
Directive.
Canada and US with respect to electrical shock,
fire and mechanical hazards in accordance with
ANSI/AAMI ES60601-1 (2005) and
CAN/CSA-C22.2 No. 60601-1 (2008)
3JSV = Control number assigned by UL.
IP33 =“Spray-proof” and “Tool-proof”.
8 (34)
Symbol Title Explanation
solid foreign objects.
Rx only Caution (U.S.): Federal law restricts this device to
sale by or on the order of a licensed healthcare
practitioner.
Power on button
Alarm silence button
Zero-point adjustment
Bluetooth
Radio transmitter
Indicating that an offset in gas readings is
discovered and performing zeroing is required.
See ch 7.4.
Device equipped with Bluetooth.
Indicates that the device has a radio transmitter.
Federal Communications Commission (FCC)
licensing.
FCC ID,
IC Model
Identifies unit has been registered as a radio
device.
IC
9 (34)
3 Device description
3.1 EMMA Capnograph overview
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.
Alarm Silence button
Battery Cover
Carry strap
ETCO
2
Capnogram
Power On
button
Battery Cover
release button
Value
Bluetooth Indicator (optional)
EMMA Sensor Body
Battery Status Indicator
Respiratory Rate Value
Alarm Status Indicator
EMMA Airway Adapter
Figure 1. EMMA Capnograph
10 (34)
3.2 Principle 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 EMMA
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.
Figure 2. Principle of operation
Spectrometer with
optical filter wheel and
infrared detector
Respiratory gas
Infrared light source
Infrared light beam
11 (34)
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