EMMA Emergency Capnograph Users Manual Edition 05 Oct 2013

Important user information Patents All users must read this entire manual to fully understand the safe use of EMMA. Declaration of conformity

Masimo holds the following patents regarding products described in this manual: SE519766; SE519779; SE523461; SE524086. Other patents pending. Trademarks

0413 Complies with 93/42/EEC Medical Device Directive. FDA Approval reference number K072813 and K063167. MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1 3JSV

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. © 2013 Masimo Sweden AB

Safety notices

Contact information

This user manual contains Warning notices and Caution notices. These notices shall be followed.

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 e-mail: [email protected]

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.

The information in this document is subject to change without notice. Article no: 0000-8114 Edition: 05 Released: October 2013

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. Revision history Edition Date 05 October 2013

Description Section 5.3.1 updated.

04

October 2013

Color change and minor updates.

03

April 2013

EMMA Analyzer removed (EOL). Revised for EMMA Emergency Capnograph and company name change.

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Contents 1

INTENDED USE ... 4

2

SAFETY INFORMATION ... 5 2.1 2.2 2.3 2.4

3

W ARNINGS ... 5 CAUTIONS ... 6 NOTES ... 6 SYMBOL DESCRIPTION... 7

DEVICE DESCRIPTION ... 9 3.1 EMMA CAPNOGRAPH OVERVIEW... 9 3.2 PRINCIPLE OF OPERATION ... 10 3.2.1 EMMA Airway Adapter ... 11

4

PREPARATIONS FOR USE ... 12 4.1 4.2 4.3 4.4

5

SETTING UP ... 12 STARTING UP ... 13 SWITCHING OFF ... 13 CONNECTING THE EMMA CAPNOGRAPH TO A TUBE OR A MASK... 14

USER 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 INDICATORS AND ALARMS ... 16 5.3.1 Alarm signals ... 16 5.3.2 Default limits for alarms ... 17 5.3.3 Alarm silence ... 17 5.3.4 Battery Status Indicator ... 17 5.3.5 Adjusting the ETCO2 alarm limits ... 18

6

EMMA AND ACCESSORIES ... 20

7

MAINTENANCE AND SERVICE ... 21 7.1 7.2 7.3 7.4 7.5 7.6 7.7

8

BATTERY REPLACEMENT ... 21 CLEANING ... 21 EMMA AIRWAY ADAPTER ... 21 ZEROING PROCEDURE ... 22 GAS SPAN CHECK ... 22 TROUBLESHOOTING ... 23 SERVICE AND PRODUCT RETURN REQUIREMENTS ... 23

TECHNICAL SPECIFICATIONS ... 24 8.1 8.2 8.3 8.4

GENERAL SPECIFICATIONS ... 24 ELECTROMAGNETIC COMPATIBILITY (EMC) ... 26 COMPLIANCE ... 30 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 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 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 TM EMMA Airway Adapter XTP windows. When using heated humidifiers special care should be 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.

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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! 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% CO2) in the EMMA Airway Adapter is of crucial importance for a successful Zeroing. Special care should be taken to avoid breathing near the EMMA Airway Adapter before or during the Zeroing procedure.

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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 [YYYY]

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.

Conformité Européenne

Complies with 93/42/EEC Medical Device Directive.

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.

IP classification indicating degree of protection against water and solid foreign objects.

IP33 =“Spray-proof” and “Tool-proof”.

0413

3JSV

IP33

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Symbol

Title

Explanation

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

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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.

Battery Cover Alarm Silence button Carry strap Battery Cover release button ETCO2 Value

Capnogram EMMA Sensor Body Power On button Battery Status Indicator Respiratory Rate Value

Alarm Status Indicator EMMA Airway Adapter

Figure 1. EMMA Capnograph

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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 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.

Infrared light source

Spectrometer with optical filter wheel and infrared detector

Respiratory gas

Infrared light beam

Figure 2. Principle of operation

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3.2.1 EMMA Airway Adapter Respiratory gas measurements are, as described in the previous section, obtained by continuously measuring the infrared light absorption through the EMMA Airway Adapter. The EMMA Airway Adapter is fitted with optical XTP™ windows that are transparent to light in the wavelength ranges of interest. The EMMA Airway Adapter may, for example, be inserted between the endotracheal tube and the resuscitation bag or between the resuscitation bag and the patient mask. The EMMA Airway Adapter is available in two models: Adult/Pediatric (Figure 3a) and Infant (Figure 3b). EMMA operates to specification with either EMMA Airway Adapter model when used with its appropriate patient population.

XTP™ window

Figure 3a. EMMA Airway Adapter Adult/Pediatric

XTP™ window

Figure 3b. EMMA Airway Adapter Infant

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.

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4 Preparations for use 4.1 Setting up Unpack and inspect the EMMA Capnograph 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 the EMMA Capnograph. It will click into place when properly inserted.

2. Press the Power On button.

3. When the EMMA Capnograph is ready the ETCO2 value is zero.

The audible alarm sound may be checked by detaching the EMMA Airway Adapter to generate a “No Adapter” alarm. When the EMMA Capnograph is ready the ETCO2 Value indicates “0” and the Respiratory Rate Value indicates “- -“. If the ETCO2 Value is non-zero, ensure that there has not been an accumulation of CO 2 between the EMMA Sensor Body and the EMMA Airway Adapter by removing and reattaching the EMMA Airway Adapter. If the ETCO2 Value still displays a non-zero value after this procedure, perform a Zeroing procedure as described in chapter 7.4 prior to using the EMMA Capnograph with a patient.

4.3 Switching off The EMMA Capnograph switches off automatically 15 seconds after that the EMMA Airway Adapter is removed or 2 minutes after a No Breath condition is detected and the Alarm Silence button is pressed. 13 (31)

4.4 Connecting the EMMA Capnograph to a tube or a mask The EMMA Capnograph can be connected to a patient in different ways. The following pictures illustrate two methods of connection.

Figure 7. EMMA Capnograph connected to an endotracheal tube.

Figure 8. EMMA Capnograph connected to a mask

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5

User interface

5.1 Controls The EMMA Capnograph has one Power On and one Alarm Silence button. These buttons may also be used for adjusting the Low and High ETCO2 alarm limits up and down.

5.2 Monitoring The EMMA Capnograph is fitted with a graphic OLED-display that shows the ETCO2 Value, the Respiratory Rate Value and a CO2 waveform (the capnogram).

5.2.1 ETCO2 The EMMA Capnograph is available in two versions displaying ETCO2 either in mmHg (0 - 99 mmHg) or kPa (0.0 - 9.9 kPa). ETCO2 values 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.

ETCO2 value

Respiratory Value

Capnogram

Saturated Capnogram

Figure 9. EMMA Capnograph display

If the CO2 level reaches or exceeds 53 mmHg/7 kPa, a horizontal dashed line will be displayed to indicate that the capnogram is saturated.

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5.3 Indicators and alarms The EMMA Capnograph is equipped with an Alarm Status Indicator and an audible alarm that may be silenced for a period of 2 minutes.

5.3.1 Alarm signals When an alarm is triggered, the Alarms Satus Indicator in the lower right corner of the display is lit with a steady or blinking yellow light depending on alarm priority, together with an audible alarm beep ((())) according to the following table:

Alarm

at t = 0 Alarm Priority: Advisory

at t = 20 Alarm Priority: Advisory

t = 40, 60, 80, ... Alarm Priority: Caution

((()))

((())) ((()))

((())) ((())) ((()))

((()))

n/a

No Breath

Low ETCO2 High ETCO2 Clogged Adapter

n/a

No Adapter

((())) Note: t = 0 is defined as the time when the alarm condition first is indicated. t = 40, 60, 80, ... shall be interpreted as "40 sec later than t = 0", "60 sec later than t = 0", "80 sec later than t = 0" etc. Active alarms are further displayed according to the following table: Alarm

Screen

ETCO2 Value

RR Value

No Breath

NORMAL

value steady

1)

"- -" flashing

Low ETCO2

NORMAL

value flashing

2)

value steady

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High ETCO2

NORMAL

value flashing

value steady

Clogged Adapter

ADAPTER

n/a

n/a

No Adapter

ADAPTER

n/a

n/a

Note 1: ETCO2 value shows momentary CO2 during No Breath. Note 2: RR value will show "- -" steady if no breath at all detected from power on.

5.3.2 Default limits for alarms The default factory settings for the No Breath and the ETCO2 alarms are as follows:

RR (No Breath)

Low

High

3 bpm (20 s)

-

OFF

50 mmHg (7.0 kPa)

ETCO2

5.3.3 Alarm silence The audible alarm can be muted for 2 minutes by pressing the Alarm Silence button. When the audible alarm is muted the yellow silence alarm indicator in the bottom right corner of the display, i.e. the Alarm Status Silence Indicator, will be lit. Pressing the Alarm Silence button again during the 2 minutes mute period will reactivate the audible alarm. If a No Breath alarm is muted by pressing the Alarm Silence button, the EMMA Capnograph will automatically switch off after 2 minutes provided that no new breaths are detected.

If the alarm disappears when the audible alarm is muted, 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.

5.3.4 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 17 (31)

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.

5.3.5 Adjusting the ETCO2 alarm limits 5.3.5.1 Adjusting the High ETCO2 alarm limit 1. Press and hold the Alarm Silence button until the display shows the “Hi ETCO2 Screen” and the ETCO2 display shows the current high ETCO2 alarm 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 ETCO2 alarm by adjusting the limit above 99 mmHg (9.9 kPa). The EMMA Capnograph 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, the EMMA Capnograph will automatically resume normal operation.

Figure 10. Adjusting the High and Low ETCO2 alarm limits 5.3.5.2 Adjusting the Low ETCO2 alarm limit 1. Press and hold the Power On button until the display shows the “Lo ETCO2 Screen” and the ETCO2 display shows the current low ETCO2 alarm 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 ETCO2 alarm by adjusting

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the limit down to 0. The EMMA Capnograph 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, the EMMA Capnograph will automatically resume normal operation. 5.3.5.3

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; 0.1 – 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. 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 Capnometer (kPa)

606100

EMMA Capnometer (mmHg)

606102

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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