Description

Product Description

The EMMA Capnograph is a quantitative mainstream carbon dioxide monitor comprised of a Sensor Body that fits on top of a disposable EMMA Airway Adapter.

Intended Use

EMMA Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients

Principles 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.

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 and Infant. EMMA

operates to specification with either EMMA Airway Adapter model when used with its appropriate patient population.

• The EMMA Airway Adapters are intended for single patient use. They are disposable and shall not be re-used. Reuse of single patient use Adapters can cause cross infection.

• EMMA Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous waste.

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.

General System Description

The EMMA system includes the following:

• EMMA Device

• Two (2) AAA Batteries

Installing Batteries

Unpack and inspect the 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.

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.

Attaching Airway Adapter

Snap the Airway Adapter into the EMMA Capnograph. It will click into place when properly inserted.

Connecting to a Tube or Mask

The EMMA Capnograph can be connected to a patient using an endotracheal tube or mask. 

Power On

1. To power on EMMA, press the Power On button.

2. When the EMMA Capnograph is ready the EtCO2 Value displays “0” and the Respiratory Rate Value displays dashes “- -“.

The audible alarm sound may be checked by detaching the EMMA Airway Adapter to generate a No Adapter alarm. If the EtCO2 Value is non-zero, ensure that there has not been an accumulation of CO2 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.

Power Off

The EMMA Capnograph switches off automatically during following conditions:

• If no breath is detected within 2 minutes from power up.

• If no breath is detected for 2 minutes and the alarm has been silenced.

• 15 seconds after the EMMA Airway Adapter is removed.

EMMA Display

The EMMA Capnograph is fitted with a graphic OLED-display that displays End-Tidal Carbon Dioxide (EtCO2) and Respiratory Rate (RR) parameters as well as the CO2 waveform (Capnogram).

EtCO2

The EMMA Capnograph is available in versions displaying End-Tidal Carbon Dioxide (EtCO2) either in mmHg (0 – 99mmHg) or kPa (0.0 – 9.9 kPa). EtCO2 values are displayed after one breath and the averaged value is updated every breath.

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.

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. If the CO2 level reaches or exceeds 53 mmHg/7 kPa, a horizontal dashed line (1) will be displayed to indicate that the capnogram is saturated.

Auto Brightness

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.

Alarms and Messages

The EMMA Capnograph is equipped with an Alarm Status Indicator and an audible alarm. The audible alarm can be silenced for 2 minutes by pressing the Alarm Silence button.

• When the audible alarm is silenced, 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 situation passes while the audible alarm is silenced, the alarm

icon turns 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