USER’S MANUAL

Important user information

All users must read this entire manual to fully
The obligations for PHASEIN under this guarantee
understand the safe use of EMMA Emergency
shall be limited to repair, or at PHASEIN's option,
Capnometer.
replacement of necessary parts or assemblies and
Declaration of conformity shall not include costs of shipping.
Claims for damages during shipment must be filed
promptly with the transportation company. All
correspondence concerning the products must
0413 specify both the name of the product and its serial
Complies with 93/42/EEC Medical Device Directive. number as written on the label on the product.
Use of the equipment for other than its intended
use, or if it has been repaired by anyone except
MEDICAL EQUIPMENT PHASEIN or a PHASEIN authorized service
WITH RESPECT TO center, or altered or modified or used without
ELECTRICAL SHOCK, following the instructions in the user manual, will
FIRE AND MECHANICAL
HAZARDS ONLY void this warranty.
IN ACCORDANCE WITH
UL 60601-1 Trademarks
3SJV
PHASEIN AB owns the following licensed
trademarks: PHASEIN IRMA and PHASEIN XTP
Safety notices Windows and EMMA.
This user manual contains Warning notices and Patents
Caution notices. These notices shall be followed.
PHASEIN AB holds the following patents
WARNING! Warnings indicate a potential harmful regarding products described in this manual:
condition that can possibly lead to injury or death. SE519766; SE519779; SE523461; SE524086.
Other patents pending.

CAUTION! Cautions indicate conditions which may lead Copyright

to the damage or malfunction of the device
This document contains proprietary information
Liability that is protected by copyright. All rights are
reserved. No part of this document may be
PHASEIN AB shall in no event be liable for any direct, photocopied, reproduced or translated to another
indirect, special or consequential damages including language without prior written consent of
without limitation damages for loss of business profits, PHASEIN AB.
loss of income, business interruption, loss of business
information, loss of use or other related exposures, All Rights Reserved. © 2006 PHASEIN AB
however caused, arising from the faulty or incorrect use Contact information
of the product.
For help with this device, please contact PHASEIN
Statement AB, Svärdvägen 15, S-18233 Danderyd, Sweden
PHASEIN AB guarantees that the product delivered has Telephone: +46 8 544 98 150
been thoroughly tested to ensure that it meets its Fax. +46 8 544 98 169
published specifications www.phasein.se,
e-mail: [email protected]
Warranty
The information in this document is subject to
PHASEIN AB warrants the products manufactured or change without notice.
distributed by them to be free from faulty materials and
workmanship for a period of 12 months from date of Article no: 0000-3804
original shipment to first end user except for disposable Edition: 04
products or products which have a stated guarantee Released: April 2007
longer or shorter than 12 months. PHASEIN will
perform warranty service at its factory.

Revision history
Edition Date Description

04 April 2007 Update for UL/CSA

03 January 2007 Corrected dimension and WEE symbol.
02 November 2006 Added explanation of symbols, catalog numbers corrected
01 October 2006 Updated Intended Use
00 September 2006 First Edition

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Contents
1 INTENDED USE ................................................................................................................................ 10
2 SAFETY INFORMATION .................................................................................................................. 11
2.1 WARNINGS ................................................................................................................................... 11
2.2 CAUTIONS .................................................................................................................................... 14
2.3 SYMBOL DESCRIPTION .................................................................................................................. 16
3 DEVICE DESCRIPTION.................................................................................................................... 17
3.1 EMMA EMERGENCY CAPNOMETER OVERVIEW ............................................................................... 17
3.2 PRINCIPLE OF OPERATION ............................................................................................................. 20
3.2.1 EMMA Airway Adapter ........................................................................................................ 23
4 PREPARATION FOR USE................................................................................................................ 25
4.1 SETTING UP .................................................................................................................................. 25
4.2 STARTING UP ................................................................................................................................ 27
4.3 SWITCHING OFF ............................................................................................................................ 29
4.4 CONNECTING THE EMMA EMERGENCY CAPNOMETER TO A BREATHING CIRCUIT .............................. 30
5 USER INTERFACE ........................................................................................................................... 32
5.1 OVERVIEW .................................................................................................................................... 32
5.2 CONTROLS ................................................................................................................................... 34
5.3 MONITORING ................................................................................................................................ 34
5.3.1 RESPIRATORY RATE Display ........................................................................................... 35
5.3.2 ETCO2 Display.................................................................................................................... 35
5.3.3 CO2 BAR GRAPH............................................................................................................... 35
5.4 INDICATORS AND ALARMS.............................................................................................................. 37
5.4.1 Default Limits....................................................................................................................... 37
5.4.2 Battery Status Indicator ....................................................................................................... 38
5.4.3 Alarm Status Indicator (EMMA Monitor only)...................................................................... 39
5.4.4 Alarm Silence (EMMA Monitor only) ................................................................................... 40
5.4.5 Display Indications .............................................................................................................. 41
5.4.6 Adjusting the ETCO2 Alarm Limits (EMMA Monitor only)................................................... 43
5.4.7 Test of Indicators and Alarms ............................................................................................. 46
6 EMMA EMERGENCY CAPNOMETER AND ACCESSORIES......................................................... 47
7 MAINTENANCE AND SERVICE ...................................................................................................... 49
7.1 BATTERY REPLACEMENT ............................................................................................................... 49
7.2 CLEANING .................................................................................................................................... 49
7.3 EMMA AIRWAY ADAPTER ............................................................................................................. 50
7.4 ZERO CALIBRATION ....................................................................................................................... 50
7.5 RECYCLING .................................................................................................................................. 51
7.6 GAS SPAN CHECK ........................................................................................................................ 51
7.7 SERVICE AND PRODUCT RETURN REQUIREMENTS .......................................................................... 52
8 TECHNICAL SPECIFICATIONS....................................................................................................... 53
8.1 GENERAL SPECIFICATIONS ............................................................................................................ 53
8.2 ELECTROMAGNETIC COMPATIBILITY (EMC).................................................................................... 59
8.3 COMPLIANCE ................................................................................................................................ 70
8.4 CLASSIFICATIONS ......................................................................................................................... 70

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 1 Intended use

The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide
concentration 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 and pediatric patients.

The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration 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
and pediatric patients.

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 2 Safety Information
2.1 Warnings
Adhere to the following warnings for safe operation of EMMA Emergency Capnometer.

WARNING! Throughout this Users Manual:

EMMA Emergency Capnometer refers to both the EMMA Monitor and EMMA Analyzer models
EMMA Monitor refers only to the EMMA Emergency Capnometer Monitor model
EMMA Analyzer refers only to the EMMA Emergency Capnometer Analyzer model

WARNING! EMMA Emergency Capnometer should only be used for the purpose and in the
manner described in this manual.

WARNING! For clinical applications EMMA Emergency Capnometer is intended for use only by
authorized and trained health care professionals.

WARNING! EMMA Emergency Capnometer must not be used with flammable anesthetic
agents.

WARNING! Use only PHASEIN manufactured EMMA Airway Adapters.

WARNING! EMMA Airway Adapters shall not be reused. Used airway adapters shall be
disposed of in accordance with local regulations for medical waste.

WARNING! The user must be aware that the EMMA Airway Adapter will add 6 ml dead space
to the breathing circuit.

WARNING! Measurements can be affected by mobile phones and RF communications

equipment. It should be assured that the EMMA Emergency Capnometer is used in the
electromagnetic environment specified.

WARNING! EMMA Emergency Capnometer is intended only as an adjunct in patient

assessment. It must be used in conjunction with the assessment of clinical signs and
symptoms.

WARNING! Remove batteries if EMMA Emergency Capnometer is not likely to be used for a
period of time greater than 90 days.

WARNING! If EMMA Emergency Capnometer is used with a respirator or with harmful gases
such as N2O, always perform a pre-use tightness check of the patient circuit.

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 WARNING! To prevent “rain-out” and moisture from draining into the EMMA Airway Adapter,
place the adapter in the vertical position as shown in the picture below.

WARNING! Do not use EMMA Emergency Capnometer with nebulized medications as this may
affect the light transmission of the EMMA Airway Adapter windows.

WARNING! Check all alarm settings before use.

WARNING! For clinical applications do not silence the audible alarm.

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.

WARNING! The user must be aware that light transmission can be affected by water rain-
out/condensation in the airway adapter if a heated humidifier is used. Dry or change airway
adapter if necessary.

2.2 Cautions
CAUTION! If the EMMA Emergency Capnometer 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 Emergency Capnometer in liquid.

CAUTION! Do not operate EMMA Emergency Capnometer at ambient temperatures less than
23°F (-5°C) or greater than 122 °F (50 °C).

CAUTION! Federal law restricts this device to sale by or on the order of a physician.

CAUTION! The use of EMMA Emergency Capnometer is restricted to one patient at a time.

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2.3 Symbol Description

Consult User’s Manual for detailed information.

Patient Isolation – Identifies patient isolation type as BF applied part.

Symbol for Waste Electrical and Electronic Equipment (WEEE).

According to the degree of protection against harmful ingress of water

IPX1 IPX1 (drip proof equipment).

Catalog number.

7 (33)
 3 Device Description
3.1 EMMA Emergency Capnometer overview
The EMMA Emergency Capnometer is a quantitative carbon dioxide mainstream monitor comprised of a
sensor body that snaps in place on top of a disposable EMMA Airway Adapter. The EMMA Emergency
Capnometer is available in two different models: EMMA Analyzer with measurement and display
functionality and EMMA Monitor with measurement, display and alarm functionality.

Feature EMMA Analyzer EMMA Monitor

Battery Status Indicator (Green) √ √
√ √
No Adapter, Check Adapter, No Breath Detected
(Indicator) (Alarm)
Alarms for High and Low ETCO2 with adjustable alarm limits √
Alarm sounder √
Alarm Status (Yellow) √

Alarm Silence button

(EMMA Monitor only)
Alarm Status Battery Cover
(EMMA Monitor only)
Carry strap
Alarm Silence Indicator
(EMMA Monitor only)

Bar Graph Battery Cover

release button

Battery Status
Indicator

Power On
button

ETCO2 Display
Respiratory Rate
Display EMMA Sensor Body

EMMA Airway Adapter

Figure 1. EMMA Monitor

Note: A figure of the EMMA Analyzer is shown in Section 5.1, Figure 9a.

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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 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.

Spectrometer with
optical filter wheel and
infrared detector
Infrared light source

Respiratory gas Infrared light beam

Figure 2. Principle of operation

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3.2.1 EMMA Airway Adapter
EMMA Emergency Capnometer 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 therefore fitted with optical XTP™ windows that are transparent to light in
the wavelength ranges of interest.

XTP™ window

Figure 3. EMMA Airway Adapter with XTP™ windows

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 4 Preparation for Use
4.1 Setting up
Unpack and inspect the EMMA Emergency Capnometer for external damage.

1. Press the battery cover release button into the EMMA Emergency Capnometer 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 battery cover back into
place.

Figure 5. Inserting batteries

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4.2 Starting up
Attach the EMMA Airway Adapter to the EMMA Emergency Capnometer. The method to attach the
EMMA Airway Adapter to the EMMA Emergency Capnometer Sensor Body is intuitive upon visual
inspection. The EMMA Airway Adapter and EMMA Emergency Capnometer Sensor Body are designed
so that they may only be connected in the proper orientation. Physical barriers prevent attachment in an
improper orientation. The EMMA Airway Adapter and EMMA Emergency Capnometer Sensor Body will
remain attached only if placed in the proper orientation and snapped into place, using light finger-
pressure force. If the EMMA Airway Adapter and EMMA Emergency Capnometer Sensor Body are not
properly fitted together they will not remain attached. It is also possible to first position the Emma Airway
Adapter in the breathing circuit and then fit the EMMA Emergency Capnometer to the Adapter. Check
that it is properly fitted and press the power on button. A start-up sequence will be initiated to check the
proper functioning of all display segments.

When the EMMA Emergency Capnometer is ready the endtidal CO2 (ETCO2) display indicates 0, the
Respiratory Display indicates “- -“, the first segment of the bar graph and the green battery status
indicator are lit.

If the ETCO2 display shows a non-zero value, ensure that there has not been an accumulation of CO2
between the EMMA Emergency Capnometer and the EMMA Airway Adapter by removing and
reattaching the EMMA Airway Adapter. If the ETCO2 still displays a non-zero value after this procedure,
perform a Zero Calibration as described in chapter 7.4 prior to using the EMMA Emergency Capnometer
with a patient.

Figure 6. Starting up the EMMA Emergency Capnometer

4.3 Switching off

EMMA Emergency Capnometer switches off automatically according to the table below.

EMMA Analyzer EMMA Monitor

Condition automatically switches automatically switches
off after: off after:
The EMMA Airway Adapter is removed. 15 sec. 15 sec.
A No Breath Detected condition is present. 2 min after Alarm
2 min
Silence is pressed

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4.4 Connecting the EMMA Emergency Capnometer to a breathing
circuit
The EMMA Emergency Capnometer can be connected to a patient circuit in different ways. The
following pictures illustrate the most common methods of connection.

Figure 7. EMMA Emergency Capnometer connected between an endotracheal tube and a resuscitation
bag

Figure 8. EMMA Emergency Capnometer connected to a mask

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 5 User Interface
5.1 Overview

Upper (▲) Limit Adjustment

Alarm Silence Button for Hi/Lo ETCO2
(EMMA Monitor only) (EMMA Monitor only)

Alarm Indicator
(EMMA Monitor only)

Alarm Silence Indicator

(EMMA Monitor only)

ETCO2 Display ETCO2 Display

CO2 Bar Graph CO2 Bar Graph

Respiratory Rate Respiratory Rate

Display Display

Battery Status Battery Status

Indicator Indicator

Power On Button Power On Button

Lower (▼) Limit Adjustment

for Hi/Lo ETCO2
(EMMA Monitor only)

Figure 9a. EMMA Analyzer Figure 9b. EMMA Monitor

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5.2 Controls
EMMA Emergency Capnometer has one Power On push button. On the EMMA Monitor, the Power On
push button may also be used for adjusting the lower alarm limit for ETCO2 and the Alarm Silence
Button may be used for adjusting the upper alarm limit for ETCO2.

EMMA EMMA
Control Description
Analyzer Monitor
Power On Turn on the device. √ √
Alarm Silence Silence active alarms for 2 minutes. √
Allow the user to change the upper high and
Upper ETCO2 Limit Adjustment low ETCO2 limit. √

Allow the user to change the lower high and

Lower ETCO2 Limit Adjustment low ETCO2 limit. √

5.3 Monitoring
The EMMA Emergency Capnometer has three displays: the ETCO2 display, the Respiratory Rate
display and the CO2 Bar Graph.

5.3.1 RESPIRATORY RATE Display

The RESPIRATORY RATE Display displays the Respiratory Rate (RR) in the unit breaths per minute
(0 - 199 bpm) using red numbers.

5.3.2 ETCO2 Display

The EMMA Emergency Capnometer is available in two versions displaying ETCO2 either in mmHg or
kPa, as indicated on the device labeling. The ETCO2 Display will show the ETCO2 values in kPa (0.0 -
9.9 kPa) or mmHg (0 - 99 mmHg) displayed as red numbers.

5.3.3 CO2 BAR GRAPH

The 14-segment red BAR GRAPH shows the current CO2 value. The table below illustrates the relation
between the bar graph and the concentration of CO2 in kPa or mmHg. The bar graph provides
qualitative information and is intended to be used as an adjunct to the two quantitative numeric displays.
The bar graph is non-linear, using smaller units of measure at the bottom and larger units of measure at
the top. The bar graph is intended to provide graphical visual communication in support of the two
primary numeric displays.
Segment kPa mmHg
13 ≥ 9.0 ≥ 90
12 ≥ 8.0 ≥ 80
Segment 13 11 ≥ 7.0 ≥ 70
10 ≥ 6.0 ≥ 60
9 ≥ 5.0 ≥ 50
8 ≥ 4.0 ≥ 40
7 ≥ 3.0 ≥ 30
Segment 0 6 ≥ 2.0 ≥ 20
5 ≥ 1.5 ≥ 10
4 ≥ 1.0 ≥8
3 ≥ 0.75 ≥6
2 ≥ 0.5 ≥4
1 ≥ 0.25 ≥2
0 ≥ 0.0 ≥0

Figure 10. EMMA Emergency Capnometer Monitor CO2 Bar Graph

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5.4 Indicators and Alarms
The EMMA Analyzer is equipped with an indicator system according to the table below. The EMMA
Monitor is equipped with an Alarm Status Indicator and an audible alarm that may be silenced for a
period of 2 minutes. The EMMA Monitor Status Indicator and audible alarm operate according to the
table below.

Condition Priority EMMA Analyzer EMMA Monitor

Low Battery Low Indicator Indicator
Check Adapter Low Indicator Alarm
No Adapter Low Indicator Alarm
No Breath Medium Indicator Alarm
ETCO2 Low Medium Alarm
ETCO2 High Medium Alarm

5.4.1 Default Limits

The default factory settings for Respiratory Rate and ETCO2 (EMMA Monitor only) are as follows:

Low High
Respiratory Rate (RR) 3 bpm -
ETCO2 (EMMA Monitor) OFF 50 mmHg (7.0 kPa)

ETCO2 values are displayed after one breath and have a continually updated breath average.

RR is displayed after two breaths and the averaged value is updated every breath.

5.4.2 Battery Status Indicator

The Battery Status Indicator is normally lit with a steady green light. Approximately 30 minutes before
depletion, the Battery Status Indicator starts blinking.

Battery OK (> 30 min) Battery LOW (< 30 min)

(Blinking)

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5.4.3 Alarm Status Indicator (EMMA Monitor only)
The Alarm Status Indicator is normally not lit. When an alarm is present it is lit with a steady yellow light.
When the alarms No Breath or ETCO2 High/Low has been present for 40 seconds the Alarm Status
Indicator will start to blink.

Alarm Priority Alarm Status Indicator Audible Alarm

Advisory Steady Yellow 1 tone beep and then silent for 24 seconds

Caution Blinking Yellow 3 tone beep and then silent for 24 seconds

5.4.4 Alarm Silence (EMMA Monitor only)

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 upper segment of the bar
graph being lit.
If a No Breath alarm is generated, the alarm can be acknowledged and
turned off by pressing the alarm silence button. The No Breath alarm
should only be turned off when a patient is not connected to the EMMA
Emergency Capnometer.

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5.4.5 Display Indications
ETCO2 Display Meanings Suggested action(s)

--
Check Adapter Check that the EMMA Airway
Adapter is not occluded.
(Blinking) Check that the EMMA Airway
No Adapter
Adapter is correctly attached.

Blinking Numbers High / Low ETCO2 Check patient

(EMMA Monitor only)

CO2 out of range Check patient

RR Display Meanings Suggested action(s)

--
No Breath Check patient

(Blinking)
Check Adapter Check that the EMMA Airway
Adapter is not occluded.

No Adapter Check that the EMMA Airway

Adapter is correctly attached.

Blinking Numbers RR out of range Check patient

Bar Graph Meanings Suggested action(s)
Bar graph shows a center-out motion Check Adapter Check that the EMMA Airway
Adapter is not occluded.

Change EMMA Airway Adapter

No Adapter Connect Airway Adapter to EMMA

Emergency Capnometer

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5.4.6 Adjusting the ETCO2 Alarm Limits (EMMA Monitor only)
5.4.6.1 Adjusting the High ETCO2 Alarm Limit
Press and hold the Alarm Silence button until the RR display shows “Hi” and the ETCO2 display shows
the current high ETCO2 alarm limit. Release the button. To adjust the alarm limit: press the Alarm
Silence button (▲) to increase, or the Power On button (▼) decrease the value. It is possible to switch
off the high ETCO2 alarm by adjusting the limit above 99 mmHg (9.9 kPa). EMMA Monitor will indicate
this setting by showing "- -" on the ETCO2 display during the adjustment routine.
If no button has been activated for a short period of time, EMMA Monitor will automatically resume
normal operation.

Figure 11. Adjusting the High and Low ETCO2 alarm limits

5.4.6.2 Adjusting the Low ETCO2 Alarm Limit

Press and hold the Power On button until the RR display shows “Lo” and the ETCO2 display shows the
current low ETCO2 alarm limit. Release the button. 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 ETCO2 alarm by adjusting the limit down to 0. EMMA Monitor will indicate this setting by showing "- -
" on the ETCO2 display during the adjustment routine.
If no button has been activated for a short period of time, EMMA Monitor will automatically resume
normal operation.

5.4.6.3 Alarm limit adjustment ranges

The adjustment ranges for the ETCO2 alarm limits are as follows:

Low High
ETCO2 displayed in mmHg OFF; 1 – 89 mmHg 11 – 99 mmHg; OFF
ETCO2 displayed in kPa OFF; 1 – 8.9 kPa 1.1 – 9.9 kPa; OFF

If the high ETCO2 limit is decreased close to the low ETCO2 limit, 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 ETCO2 limit is increased close to the high ETCO2 limit, 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.

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5.4.7 Test of Indicators and Alarms
To test the visible status indicator and the audible alarm (EMMA Monitor only) perform the following
steps.

1. Start-up the EMMA Emergency Capnometer as described in chapter 4.2.

2. Remove the Airway Adapter

This will start the Indicator on EMMA Analyzer and the Alarm on EMMA Monitor.

When the test is completed, attach the Airway Adapter to the Sensor Body as described in chapter 4.2.
The EMMA Emergency Capnometer is ready for use.

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 6 EMMA Emergency Capnometer and Accessories
Below is a list of device models, versions and approved accessories. For an up-to date list of
accessories visit www.phasein.se

EMMA Emergency Capnometer and Accessories Catalog number

EMMA Analyzer (kPa) 601100
EMMA Analyzer (mmHg) 601102
EMMA Monitor (kPa) 605100
EMMA Monitor (mmHg) 605102
EMMA Airway Adapter, box of 25 100620
EMMA Airway Adapter, 6 boxes of 25 100621
EMMA Airway Adapter Infant, box of 10 100660
EMMA Airway Adapter Infant, 6 boxes of 10 100661
EMMA Pouch, Box of 10 100680
EMMA Lanyard, Bag of 10 100684

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 7 Maintenance and Service
7.1 Battery Replacement
The EMMA Emergency Capnometer is equipped with a green Battery Status indicator. The Battery
Status indicator starts blinking when the remaining lifetime of the batteries is approximately 30 min.

To replace the batteries:

ƒ Open the battery compartment by pressing the release button.

ƒ Pull gently out the depleted batteries.

ƒ Insert two new AAA type batteries into the battery compartment.

ƒ NOTE: Make sure that the batteries are fitted according to the polarity marking!

ƒ When the batteries are properly in place, gently snap the battery cover back into place.

7.2 Cleaning
• Remove the batteries before cleaning.

• EMMA Emergency Capnometer can be cleaned using a cloth moistened with isopropyl alcohol.

CAUTION! DO NOT immerse EMMA Emergency Capnometer in any liquid.

7.3 EMMA Airway Adapter

• The EMMA Airway Adapters are intended for single patient use. They are disposable and shall not
be re-used.

• Treat used EMMA Airway Adapters in accordance with hospital protocol for disposable items.

7.4 Zero Calibration

To zero calibrate EMMA Emergency Capnometer proceed as follows:
ƒ Make sure that the EMMA Airway Adapter is properly attached.

• Start EMMA Emergency Capnometer by pressing the ON button.

• EMMA Analyzer: Press and hold down the ON button until the ETCO2 display shows “10” and
the RR display shows “C0”. Keep the button depressed while the ETCO2 Display starts
"counting down" i.e. displaying "9" - "8" - "7" etc and until "0" is displayed.

EMMA Monitor: Press and hold down simultaneously the ON and Alarm Silence button until the
ETCO2 display shows “10” and the RR displays “C0”. Keep both buttons depressed while the
ETCO2 Display starts "counting down" i.e. displaying "9" - "8" - "7" etc and until "0" is displayed.
• Once “0” is displayed on the ETCO2 display, zero calibration of the EMMA Emergency
Capnometer is completed.

Gas readings should be verified with a reference instrument at regular intervals. A zero reference
calibration of the IR measurement should be performed whenever an offset in gas readings is
discovered.

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7.5 Recycling
The EMMA Emergency Capnometer and the EMMA Airway Adapter shall be disposed in accordance to
local regulations for recyclable products. Dispose the old batteries according to local regulations.

7.6 Gas Span Check

Gas readings should be verified at regular intervals with a reference instrument.

7.7 Service and Product Return Requirements

Please contact PHASEIN about how to return a product for service using the contact details under
Important User Information on the front inside cover of this manual. Products under warranty will be
exchanged free of charge except for the cost of inbound freight.

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8 Technical Specifications
8.1 General Specifications
General EMMA Emergency Capnometer
Description Compact, battery powered, quantitative capnometer for mainstream
CO2 monitoring of adults and pediatrics.
Measurements Non-dispersive IR absorption
Models EMMA Analyzer (non-alarm)
EMMA Monitor (full-alarm)
Versions CO2 displayed in kPa or mmHg
Warm up In operation and full accuracy within 5 sec.
Calibration No routine calibration required
Certifications CE marked per 93/42/EEC, FDA 510(k) and UL/CSA 60601-1
Dimensions 52 x 39 x 39 mm (2.1 x 1.5 x 1.5 inches)
Weight Approximately 60 g (2.1 oz) with batteries
Shock absorption Withstands repeated 1 m drops
Environment
Operating conditions Temperature: -5 - +50°C (23 to 122°F)
Humidity: 10 - 95% RH (non-condensing)
Atmospheric pressure: 70 - 120 kPa (1) (2)
Storage conditions Temperature: -30 - +70°C (-22 to 158°F)
Humidity: 5 - 100% RH (condensing)
Atmospheric pressure: 50 - 120 kPa
Displays
ETCO2 LED Numeric Display
Respiratory rate LED Numeric Display
CO2 Bar Graph 14 segment LED bar graph
Controls
Power ON key
Alarm Silence 2 min. alarm silence key (EMMA Monitor only)
ETCO2 Up/Down key for setting alarm limits (EMMA Monitor only)
CO2
Range 0 - 99 mmHg (0 - 9.9 kPa) (3)
Accuracy 0-40 mmHg ± 2 mmHg, 41-99 mmHg 6% of reading, during standard
conditions.(4) (5)
Rise time ≤ 60 ms
Total system response time < 0.5 sec.

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General EMMA Emergency Capnometer
Respiratory Rate (RR)
Respiratory rate 3 - 150 breaths/min
Accuracy ± 1 bpm
Breath detect Adaptive threshold, minimum 1 kPa CO2 change
EMMA Airway Adapters
Adult 6 ml dead space
Indicators and Alarms
EMMA Analyzer Indicators for: No Adapter, Check Adapter, No Breath Detected, Low
Battery
EMMA Monitor Alarms for: No Adapter, Check Adapter, No Breath Detected, Low
Battery, Low ETCO2, High ETCO2
Sound Intensity Level ≥ 80 dBA (EMMA Monitor only)
Power requirements
Batteries Two (2) AAA Cell Alkaline Batteries (2 x 1.5VDC) (IEC Type LR03)
Battery life time 8 hours of normal use
Power status LED indicator

Notes:
(1)
EMMA Emergency Capnometer displays CO2 in partial pressure units (kPa or mmHg) and thus does
not require barometric pressure compensation.
(2)
High altitude measurements are affected by pressure broadening. To compensate for this effect, add
offset to displayed ETCO2 value according to the following table based on altitude and range of ETCO2
being displayed by the EMMA Emergency Capnometer:

ETCO2 Offset
Based on Range Displayed
Altitude 5-40 mmHg / 0.6-5.3 kPa 40 + mmHg / 5.3 + kPa
5 000 ft / 1 500 m + 1 mmHg / 0.1 kPa + 2 mmHg / 0.3 kPa
6 000 ft / 1 800 m + 2 mmHg / 0.3 kPa + 4 mmHg / 0.5 kPa
7 000 ft / 2 100 m + 3 mmHg / 0.4 kPa + 6 mmHg / 0.8 kPa
8 000 ft / 2 450 m + 4 mmHg / 0.5 kPa + 8 mmHg / 1.1 kPa
9 000 ft / 2 750 m + 5 mmHg / 0.7 kPa + 10 mmHg / 1.3 kPa
10 000 ft / 3 050 m + 6 mmHg / 0.8 kPa + 12 mmHg / 1.6 kPa

(3)
Gas reading showing actual partial pressure at current humidity level.
(4)
To include quantitative effect on gas reading from variations in environment conditions and presence
of N2O, anesthetic agents, Ethanol, Isopropyl alcohol, He, Acetone and Methane, then the CO2
accuracy range should be increased to ± 4 mmHg or 10% of reading whichever is the greater.
(5)
CO2 was tested at a RR of 40. As RR rates increases above 60 the accuracy range will also increase.

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8.2 Electromagnetic Compatibility (EMC)

Guidance and PHASEIN’s declaration – electromagnetic emissions –

for EMMA Emergency Capnometer

The EMMA Emergency Capnometer is intended for use in the electromagnetic environment specified
below. The customer or the user of the EMMA Emergency Capnometer should assure that it is used in
such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions Group 1 The EMMA Emergency Capnometer uses RF energy only
CISPR 11 for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.

RF emissions Class B The EMMA Emergency Capnometer is suitable for use in

CISPR 11 all establishments including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.

Harmonic emissions Not applicable Not applicable

IEC 61000-3-2

Voltage fluctuations/ Not applicable Not applicable

flicker emissions
IEC 61000-3-3

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 Guidance and PHASEIN’s declaration – electromagnetic immunity –
for EMMA Emergency Capnometer

The EMMA Emergency Capnometer is intended for use in the electromagnetic environment specified
below. The customer or the user of the EMMA Emergency Capnometer should assure that it is used in
such an environment.

Immunity test IEC 60601 Compliance Electromagnetic environment –

test level level guidance
Electrostatic ±6kV contact ±6 kV contact Floors should be wood, concrete or
discharge (ESD) ±8 kV air ±8 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.

Electrical fast ±2 kV for Not applicable Not applicable

transient/burst power supply
IEC 61000-4-4 lines
±1 kV for
input/output
lines

Surge ±1 kV Not applicable Not applicable

IEC 61000-4-5 differential
mode

Voltage dips, short Not applicable Not applicable Not applicable

interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11

Power frequency 3 A/m 30 A/m Power frequency magnetic fields

(50/60 Hz) should be at levels characteristic of a
magnetic field typical location in a typical commercial
IEC 61000-4-8 or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

27 (33)
 Guidance and PHASEIN’s declaration – electromagnetic immunity –
for EMMA Emergency Capnometer
The EMMA Emergency Capnometer is intended for use in the electromagnetic environment specified
below. The customer or the user of the EMMA Emergency Capnometer should assure that it is used in
such an environment.

Immunity test IEC 60601 test Compliance Electromagnetic environment – guidance

level level
Portable and mobile RF communications
equipment should be used no closer to any
part of the EMMA Emergency Capnometer
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.

Recommended separation distance

Conducted RF 3V 3V
IEC 61000-4-6 150 kHz to 80 d = 1.17√P
MHz
d = 0.18√P 80 MHz to 800 MHz

Radiated RF d = 0.35√P 800 MHz to 2.5 GHz

IEC 61000-4-3 3 V/m 20 V/m
80 MHz to 2.5 where P is the maximum output power rating of
GHz the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range.b Interference may occur
in the vicinity of equipment marked with the
following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the EMMA Emergency Capnometer is used exceeds the applicable RF compliance
level above, the EMMA Emergency Capnometer should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the EMMA Emergency Capnometer.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 20 V/m.

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 Recommended separation distances between portable and mobile RF communications
equipment and the EMMA Emergency Capnometer

The EMMA Emergency Capnometer is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the EMMA Emergency
Capnometer can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the EMMA Emergency
Capnometer as recommended below, according to the maximum output power of the communications
equipment.

Rated maximum Separation distance according to frequency of transmitter

output power of m
transmitter
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.17√P d = 0.18√P d = 0.35√P

0.01 0.12 0.018 0.035

0.1 0.37 0.057 0.11

1 1.2 0.18 0.35

10 3.7 0.57 1.1

100 12 1.8 3.5

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Warning: Measurements can be affected by mobile phones and RF communications equipment. It

should be assured that the EMMA Emergency Capnometer is used in the electromagnetic environment
specified.

29 (33)
8.3 Compliance
MDD 93/42/EEC
ISO 21647:2004
EN/IEC 60601-1:1990, Amendment1 (1991), Amendment2 (1995)
EN/IEC 60601-1-2:2001
ISO 5356-1
EN/IEC 60601-1-8:2003
prEN 1789:2004

8.4 Classifications
According to the type of protection against electric shock
INTERNALLY POWERED EQUIPMENT (Battery power)

According to the degree of protection against electric shock

TYPE BF APPLIED PART

According to the degree of protection against harmful ingress of water

IPX1 (drip proof EQUIPMENT)

According to the mode of operation

CONTINUOUS OPERATION

According to the degree of safety of application in the presence of a FLAMMABLE ANESTHETIC

MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE
EQUIPMENT not suitable for use in the presence of FLAMMABLE ANESTHETIC
MIXTURE WITH AIR; OR WITH OXYGEN OR NITROUS OXIDE

According to the susceptibility to vibrations

MEDICAL DEVICE FOR USE IN ROAD AMBULANCES
(ASD 5 - 20 Hz,: 00.5 g2/Hz, ASD 20 - 200 Hz: 0.05 g2/Hz -3 dB/octave)

According to sterility
No part of the EMMA Emergency Capnometer is sterile.

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Notes:

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Notes:

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PHASEIN AB
Svärdvägen 15
182 33 Danderyd
Sweden
www.phasein.se

All Rights Reserved. © 2006 PHASEIN AB

The information in this document is subject to change without notice.

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