Masimo EMMA User manual

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.
Disclaimer
Masimo Sweden AB shall in no event be liable for any
direct, indirect, special or consequential damages
including without limitation damages for loss of
business profits, loss of income, business interruption,
loss of business information, loss of use or other related
exposures, however caused, arising from the faulty or
incorrect use of the product.
Liability
Masimo Sweden AB guarantees that the product
delivered has been thoroughly 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 equipment for other than its intended use, or
if it has been repaired by anyone except Masimo
Sweden AB or a Masimo Sweden AB authorized
service center, or altered or modified or used
without following the instructions in the user
manual, will void the warranty.
Trademarks
Masimo Sweden AB owns the following licensed
trademarks: Masimo EMMA and Masimo XTP
Windows.
Patents
Masimo Sweden AB holds the following patents
regarding products described in this manual:
SE519766; SE519779; SE523461; SE524086.
Other patents pending.
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. © 2013 Masimo Sweden AB
Contact information
Masimo Sweden AB
Svärdvägen 15
SE-182 33 Danderyd
Sweden
Telephone: [phone]
Fax: [phone]
Web site: www.masimo.com
e-mail: [email protected]
The information in this document is subject to
change without notice.
Article no: 0000-8114
Edition: 03
Released: April 2013
CAUTION: Federal law restricts this
device to sale by or on the order of a
physician.
For professional use. See instructions
for use for full prescribing information,
including indications, contraindicatins,
warnings, precautions and adverse
events.
Revision history
Edition
Date
Description
03
April 2013
EMMA Analyzer removed (EOL). Revised for EMMA Emergency Capnograph and company name
change.
MEDICAL EQUIPMENT
WITH RESPECT TO
ELECTRICAL SHOCK,
FIRE AND MECHANICAL
HAZARDS ONLY
IN ACCORDANCE WITH
UL 60601-1
3JSV
NOTE! Alert the user to relevant facts and conditions.
2 (32)

Contents
1INTENDED USE .................................................................................................................................. 4
2SAFETY INFORMATION .................................................................................................................... 5
2.1 WARNINGS ..................................................................................................................................... 5
2.2 CAUTIONS ...................................................................................................................................... 6
2.3 NOTES ........................................................................................................................................... 6
2.4 SYMBOL DESCRIPTION .................................................................................................................... 7
3DEVICE DESCRIPTION...................................................................................................................... 9
3.1 EMMA OVERVIEW .......................................................................................................................... 9
3.2 PRINCIPLE OF OPERATION ............................................................................................................. 10
3.2.1 EMMA Airway Adapter ........................................................................................................ 11
4PREPARATIONS FOR USE ............................................................................................................. 12
4.1 SETTING UP .................................................................................................................................. 12
4.2 STARTING UP................................................................................................................................ 13
4.3 SWITCHING OFF ............................................................................................................................ 13
4.4 CONNECTING EMMA TO A TUBE OR MASK ...................................................................................... 14
5USER INTERFACE ........................................................................................................................... 15
5.1 CONTROLS ................................................................................................................................... 15
5.2 MONITORING ................................................................................................................................ 15
5.2.1 ETCO2................................................................................................................................. 15
5.2.2 Respiratory Rate ................................................................................................................. 15
5.2.3 Capnogram.......................................................................................................................... 15
5.3 DEFAULT LIMITS FOR INDICATOR AND ALARMS ................................................................................ 16
5.3.1 Battery Status Indicator ....................................................................................................... 16
5.3.2 Alarm Status Indicator ......................................................................................................... 17
5.3.3 Alarm Silence ...................................................................................................................... 18
5.3.4 Adjusting the ETCO2Alarm Limits ...................................................................................... 19
6EMMA AND ACCESSORIES............................................................................................................ 20
7MAINTENANCE AND SERVICE ...................................................................................................... 21
7.1BATTERY REPLACEMENT............................................................................................................... 21
7.2 CLEANING .................................................................................................................................... 21
7.3 EMMA AIRWAY ADAPTER ............................................................................................................. 21
7.4 ZEROING PROCEDURE................................................................................................................... 22
7.5 GAS SPAN CHECK ........................................................................................................................ 22
7.6 TROUBLESHOOTING ...................................................................................................................... 23
7.7 SERVICE AND PRODUCT RETURN REQUIREMENTS .......................................................................... 23
8TECHNICAL SPECIFICATIONS....................................................................................................... 24
8.1 GENERAL SPECIFICATIONS ............................................................................................................ 24
8.2 ELECTROMAGNETIC COMPATIBILITY (EMC).................................................................................... 26
8.3 COMPLIANCE ................................................................................................................................ 30
8.4 CLASSIFICATIONS ......................................................................................................................... 30
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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.
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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! EMMA Airway Adapter shall not be reused. Reuse of the single use Adapter 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 must 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 N2O, always
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 XTPTM windows. When using heated humidifiers special care should be
taken 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 volume 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.
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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. The remaining lifetime for lithium batteries may be significantly less than 30
minutes when the Battery Status Indicator starts blinking.
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 cell promptly. Keep
away from children.
WARNING! Use only Alkaline 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! 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! Always carry spare batteries in the EMMA pouch.
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2.4 Symbol Description
Symbol
Title
Explanation
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
Catalog number
Serial number
Batch code
Manufacturer
Accompanied by the name and address of the
manufacturer.
Use by date [YYYY-MM-DD]
Indicates that the device should not be taken into
operation after the date accompanying the symbol
(EMMA airway adapters).
Temperature limitation
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)
For EU only:
Electrical and electric equipment shall be collected
and recycled in accordance with Directive
2002/96/EC.
0413
Conformité Européenne
Complies with 93/42/EEC Medical Device
Directive.
3JSV
UL classification mark
Classified by Underwriters Laboratories Inc. for
Canada and US with respect to electrical shock,
fire and mechanical hazards in accordance with
UL60601-1 and CSA 22.2 No.601.1-M90.
3JSV = Control number assigned by UL.
IP33
IP classification indicating degree
of protection against water and
solid foreign objects.
IP33 =“Spray-proof” and “Tool-proof”.
7(32)

Symbol
Title
Explanation
Rx only
Caution: Federal (U.S.) law restricts this device to
sale by or on the order of a licensed healthcare
practitioner.
Power on button
Alarm silence button
8(32)

3 Device Description
3.1 EMMA overview
EMMA is a quantitative mainstream carbon dioxide monitor comprised of a sensor body that snaps in
place on top of a disposable EMMA Airway Adapter.
Figure 1. EMMA
Carry strap
Battery Cover
release button
Battery Cover
Power On
button
Alarm Status Indicator
ETCO
2
Value
Respiratory Rate Value
EMMA Airway Adapter
Capnogram
Battery Status Indicator
Alarm Silence button
EMMA Sensor Body
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Spectrometer with
optical filter wheel and
infrared detector
3.2 Principle of operation
The measurement of CO2in 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.
Figure 2. Principle of operation
Infrared light source
Infrared light beam
Respiratory gas
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3.2.1 EMMA Airway Adapter
The EMMA Airway Adapter is available in two models: Adult/Pediatric (Figure 3a) and Infant (Figure 3b).
EMMA operates to specification with either Airway Adapter model when used with its appropriate patient
population. A trained medical professional must determine the proper Airway Adapter model for each
patient application. No hardware or software configuration changes result from the EMMA Airway
Adapter model selected.
EMMA snaps in place on top of the EMMA Airway Adapter. 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. Respiratory gas measurements are, as described in the previous section, obtained by
continuously measuring the infrared light absorption through the Airway Adapter. The EMMA Airway
Adapter is fitted with optical XTP™ windows that are transparent to light in the wavelength ranges of
interest.
Figure 3a. EMMA Airway Adapter Adult/Pediatric Figure 3b. EMMA Airway Adapter Infant
XTP™ window
XTP™ window
11(32)

4 Preparations for Use
4.1 Setting up
Unpack and inspect EMMA for external damage. Please contact your local distributor in case of damage.
1. Press the battery cover release button into the EMMA sensor body until the battery cover pops
off.
Figure 4. Releasing the battery cover
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.
Figure 5. Inserting batteries
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4.2 Starting up
1. Snap the EMMA Airway Adapter into EMMA. It will click into place when properly seated.
2. Press the Power On button.
3. When EMMA is ready the ETCO2value is zero.
The audible alarm sound may be checked by detaching the Airway Adapter to generate a “Check
Adapter” alarm.
When EMMA is ready the end-tidal carbon dioxide (ETCO2) display indicates 0 and the Respiratory
Display indicates “- -“.
If the ETCO2display shows a non-zero value, ensure that there has not been an accumulation of CO2
between EMMA and the EMMA Airway Adapter by removing and reattaching the EMMA Airway Adapter.
If the ETCO2still displays a non-zero value after this procedure, perform a Zeroing procedure as
described in chapter 7.4 prior to using EMMA with a patient.
4.3 Switching off
EMMA switches off automatically 15 Sec after that the EMMA Airway Adapter is removed or 2 min after
a No Breath condition is detected and the Alarm Silence button is pressed.
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4.4 Connecting EMMA to a tube or mask
EMMA can be connected to a patient in different ways. The following pictures illustrate two methods of
connection.
Figure 7. EMMA connected to an endotracheal tube.
Figure 8. EMMA connected to a mask
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Saturated Capnogram
5 User Interface
5.1 Controls
EMMA has one Power On and one Alarm Silence button. These buttons may also be used for adjusting
the Low and High ETCO2alarm limits up and down.
5.2 Monitoring
EMMA is fitted with a graphic OLED-display that shows the ETCO2value, the Respiratory Rate and a
CO2waveform (the capnogram).
5.2.1 ETCO2
EMMA is available in two versions displaying ETCO2either in mmHg (0 - 99 mmHg) or kPa (0.0 - 9.9
kPa). ETCO2values are displayed after one breath and the averaged value is updated every breath.
5.2.2 Respiratory Rate
Respiratory Rate (RR) is displayed as breaths per minute (3 - 150 bpm). RR is displayed after two
breaths and the value is updated every breath.
5.2.3 Capnogram
The capnogram is displayed as a filled graph with a 14.4 sec horizontal sweep and a fixed 0-53
mmHg/0-7 kPa scale.
Figure 9. EMMA Display
If the CO2level reaches or exceeds 53 mmHg/7 kPa, a horizontal dashed line will be displayed to
indicate that the capnogram is saturated.
Respiratory
Value
ETCO
2
value
Capnogram
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5.3 Default Limits for indicator and alarms
The default factory settings for the No Breath and the ETCO2alarms are as follows:
Low High
RR (No Breath) 3 bpm (20 s) -
ETCO2OFF 50 mmHg (7.0 kPa)
5.3.1 Battery Status Indicator
The Battery Status Indicator is normally lit with a steady green light in the upper right corner of the
display (Battery OK). When batteries are low, the Battery Status Indicator starts blinking (approximately
30 minutes before depletion for alkaline batteries).
Battery OK
Battery low
(Blinking)
There will be an audible tone beep repeated every 80 seconds when batteries are low.
The terminal voltage of alkaline batteries recovers when the batteries are not in use. The remaining time
prediction is thus unreliable during the first period after power on. Nearly depleted batteries may still be
able to provide a voltage above the threshold for battery low indication, even if the internal battery
resistance is too high to provide sufficient current to start up the device next time the power on button is
activated.
To extend battery life time the EMMA display has an automatic brightness control which will be activated
during stable conditions. Any change in displayed vital parameters, alarm or pressing any button will
return the EMMA display to normal brightness.
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. The remaining lifetime for lithium batteries may be significantly less than 30 minutes when
the Battery Status Indicator starts blinking.
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 or Energizer Ultimate Lithium L92 batteries. Use of other Lithium
batteries may present a risk of fire or explosion.
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5.3.2 Alarm Status Indicator
When an alarm is triggered, the indicator in the lower right corner of the display is lit with a steady or
blinking yellow light depending on alarm priority.
Active alarms are displayed according to the following table:
Alarm Screen ETCO2value RR value
Apnea NORMAL value steady
1)
"- -" flashing
2)
Clogged Adapter ADAPTER n/a n/a
No Adapter ADAPTER n/a n/a
High ETCO2NORMAL value flashing value steady
Low ETCO2NORMAL value flashing value steady
Note 1: ETCO2value shows momentary CO2during apnea.
Note 2: RR value will show "- -" steady if no breath at all detected from power on.
Alarm
Priority Indication Audible Alarm Condition
Advisory Steady yellow alarm indicator 1 tone beep
2 tone beep
No breath (first 20 s)
ET CO2Low (first 40 s)
ET CO2High (first 40 s)
No breath (20 - 40 s)
Caution Blinking yellow alarm indicator 3 tone beep
repeated every 20
seconds
No breath (after 40 s)
ET CO2Low (after 40 s)
ET CO2High (after 40 s)
Advisory Adapter flashing yellow
Steady yellow alarm indicator
1 tone beep No Adapter
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Advisory Adapter steady yellow
Flashing red adapter window
Steady yellow alarm indicator
1 tone beep Clogged Adapter
5.3.3 Alarm Silence
If an alarm is active, pressing the Alarm Silence button will silence the
alarm for a period of 2 minutes.
The Alarm Silence status is indicated by the yellow silence alarm
indicator in the bottom right corner of the display.
If a No Breath alarm is turned off by pressing the Alarm Silence button,
EMMA will automatically switch off after 2 minutes if no new breath takes
are detected.
If the alarm disappears during the silence period, the alarm icon will turn
green. Pressing the Alarm Silence button during no alarm will also show
a green silence alarm indicator in the bottom right corner of the display.
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5.3.4 Adjusting the ETCO2Alarm Limits
5.3.4.1 Adjusting the High ETCO2Alarm Limit
1. Press and hold the Alarm Silence button until the display shows the “Hi ETCO2 Screen” and the
ETCO2display shows the current high ETCO2alarm limit.
2. Release the button.
3. To adjust the alarm limit: press the Alarm Silence button (▲) to increase, or the Power On
button (▼) to decrease the value. It is possible to switch off the high ETCO2alarm by adjusting
the limit above 99 mmHg (9.9 kPa). EMMA will indicate this setting by showing "- -" on the
ETCO2display during the adjustment routine.
If no button has been activated for a short period of time, EMMA will automatically resume normal
operation.
Figure 10.Adjusting the High and Low ETCO2alarm limits
5.3.4.2 Adjusting the Low ETCO2Alarm Limit
1. Press and hold the Power On button until the display shows the “Lo ETCO2 Screen” and the
ETCO2display shows the current low ETCO2alarm limit.
2. Release the button.
3. To adjust the alarm limit: press the Alarm Silence button (▲) to increase, or the Power On
button (▼) to decrease the value. It is possible to switch off the low ETCO2alarm by adjusting
the limit down to 0. EMMA will indicate this setting by showing "- -" on the ETCO2display during
the adjustment routine.
If no button has been activated for a short period of time, EMMA will automatically resume normal
operation.
5.3.4.3 Alarm limit adjustment ranges
The adjustment ranges for the ETCO2alarm limits are as follows:
Low High
ETCO2displayed in mmHg OFF; 1 – 89 mmHg 11 – 99 mmHg; OFF
ETCO2displayed in kPa OFF; 0.1 – 8.9 kPa 1.1 – 9.9 kPa; OFF
If the high ETCO2limit is decreased close to the low ETCO2limit, the low limit will be automatically
adjusted in order to maintain a minimum difference of 10 mmHg (1.0 kPa) between the high and low
alarm limit. Similarly, if the low ETCO2limit is increased close to the high ETCO2limit, the high limit will
be automatically adjusted to maintain a minimum difference of 10 mmHg (1.0 kPa) between the high and
low alarm limit.
Note: The alarm limits will be reset to default values after power off.
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6 EMMA and Accessories
Below is a list of device models, versions and approved accessories. For an up to date list of
accessories visit www.masimo.com
EMMA and Accessories Catalog number
EMMA (kPa) 605100
EMMA (mmHg) 605102
EMMA Airway Adapter Adult/Pediatric, box of 25 100620
EMMA Airway Adapter Infant, box of 10 100660
EMMA Pouch, Box of 10 100680
EMMA Lanyard, Bag of 10 100684
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