605100, 605102, 655100, 655102 USER’S MANUAL
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.
Contents 1 INTENDED USE .................................................................................................................................. 4 2 SAFETY INFORMATION .................................................................................................................... 5 2.1 2.2 2.3 2.4 3 WARNINGS ..................................................................................................................................... 5 CAUTIONS ......................................
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.
2 Safety information Adhere to the following warnings, cautions and notes for safe operation of EMMA. 2.1 Warnings WARNING! EMMA should only be used for the purpose and in the manner described in this manual. WARNING! EMMA is intended for use by authorized health care professionals only. WARNING! EMMA must not be used with flammable anesthetic agents. WARNING! Use only EMMA Airway Adapters manufactured by Masimo. WARNING! No modification of the EMMA probe or the EMMA Airway Adapters is allowed.
WARNING! Replace batteries immediately when the Battery Status Indicator starts blinking. Remaining battery time depends on battery type and other circumstances and cannot be reliably predicted. WARNING! Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100C (212F) or incinerate. Dispose of used cell promptly. Keep away from children. WARNING! Use only Alkaline batteries or Energizer Ultimate Lithium L92 batteries.
NOTE! EMMA Bluetooth complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
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).
Symbol Title Explanation solid foreign objects. Rx only Caution (U.S.): Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Power on button Alarm silence button Zero-point adjustment Indicating that an offset in gas readings is discovered and performing zeroing is required. See ch 7.4. Device equipped with Bluetooth. Bluetooth Indicates that the device has a radio transmitter. Radio transmitter Federal Communications Commission (FCC) licensing.
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 Bluetooth Indicator (optional) EMMA Sensor Body Power On button Battery Status Indicator Respiratory Rate Value Alarm Status Indicator EMMA Airway Adapter Figure 1.
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.
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.
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.
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 “- -“.
4.3 Switching off The EMMA Capnograph switches off automatically during following conditions: After 2 minutes if no breath is detected. After 2 minutes if No Breath condition is detected and the Alarm Silence is activated. After 15 seconds if the EMMA Airway Adapter is removed. 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.
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 Bluetooth (optional) The EMMA Bluetooth (REF: 655100 and 655102) provides a Bluetooth Low Energy (LE) wireless option to allow connection to a compatible smart device or host. EMMA Bluetooth can only communicate to a single smart device at a time to minimize the risk of unauthorized access.
5.3 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). 5.3.1 ETCO2 The EMMA Capnograph is available in 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. 5.3.2 Respiratory Rate Respiratory Rate (RR) is displayed as breaths per minute (3 - 150 bpm).
5.4 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. 5.4.1 Alarm signals When an alarm is triggered, an Alarm 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: Low at t = 20 Alarm Priority: Low t = 40, 60, 80, ..
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.
5.4.4 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. 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.
Figure 10. Adjusting the High and Low ETCO2 alarm limits 5.4.5.2 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 the limit down to 0.
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 Catalog number (REF) EMMA and accessories Description 605100 EMMA (kPa) EMMA Emergency Capnograph (full-alarm, display in kPa). Color: green 605102 EMMA (mmHg) EMMA Emergency Capnograph (full-alarm, display in mmHg). Color: green 655100 EMMA Bluetooth (kPa) EMMA Emergency Capnograph with Bluetooth (full-alarm, display in kPa).
7 Maintenance and service 7.1 Battery replacement WARNING! Replace batteries immediately when the Battery Status Indicator starts blinking. Remaining battery time depends on battery type and other circumstances and cannot be reliably predicted. WARNING! Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100C (212F) or incinerate. Dispose of used cell promptly. Keep away from children.
7.4 Zeroing procedure Zeroing is recommended after 500 hours of operation or whenever an offset in gas readings is discovered. Zeroing of the EMMA Capnograph is performed by the following procedure: 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. 1. Start the EMMA Capnograph by pressing the Power On button. 2.
Directions Attach the flow regulator to the calibration gas cylinder. Ensure that the valve is shut off completely. 1. Attach a new EMMA Airway Adapter to the EMMA Capnograph. 2. Turn on the EMMA Capnograph and ensure that the ETCO2 reading is zero. Otherwise conduct a Zeroing procedure according to chapter 7.4 above before proceeding. 3. Insert the 15M connector into one end of the EMMA Airway Adapter, and connect a second EMMA Airway Adapter to the other end (see picture). 4. Turn on the regulator flow.
7.
8 Technical specifications 8.1 General specifications Description Compact, battery powered, quantitative capnograph for mainstream CO2 monitoring of adult, pediatric and infant patients. Measurements(1) The CO2 partial pressure is measured based on a 2 channel NDIR type gas analyzer at 4–5 µm with data acquisition rate at 10 kHz (sample rate 20 Hz / channel). Models CO2 displayed in kPa or mmHg Warm up In operation and full accuracy within 15 s.
Infant Dead space 1 ml, Flow resistance < 1,3 cm H2O (@ 10 LPM) Alarms No Breath, Low ETCO2, High ETCO2, Clogged Adapter, No Adapter, Zero point adjustment, Low Battery Sound Intensity Level ≥ 57 dB(A); ≤ 67 dB(A) Batteries Two AAA Cell batteries (2x1.5VDC): Alkaline IEC:LR03 or Energizer Ultimate Lithium L92 batteries(5). Use of other Lithium batteries may present a risk of fire or explosion.
8.3 Electromagnetic compatibility (EMC) Guidance and Masimo’s declaration – electromagnetic emissions The EMMA gas analyzer is intended for use in the electromagnetic environment specified below. The customer or the user of the EMMA gas analyzer should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 EN 55011 Group 1 The EMMA gas analyzer uses RF energy only for its internal function.
The EMMA gas analyzer will function according to general specification in chapter 8.1 and will not cause any safety hazard or false alarm when exposed to the following immunity test levels. Guidance and Masimo’s declaration – electromagnetic immunity The EMMA gas analyzer is intended for use in the electromagnetic environment specified below. The customer or the user of the EMMA gas analyzer should assure that it is used in such an environment.
Guidance and Masimo’s declaration – electromagnetic immunity The EMMA gas analyzer is intended for use in the electromagnetic environment specified below. The customer or the user of the EMMA gas analyzer should assure that it is used in such an environment.
analyzer. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the EMMA gas analyzer The EMMA gas analyzer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
8.4 Compliance EN 60601-1:2006, Amendment 1 (2012) EN 60601-1-2:2007, C1:2010 EN 60601-1-8:2007, C1:2010, A1:2013 EN 1789:2007, A1:2010 EN 13718-1:2008 EN ISO 80601-2-55:2012 EN ISO 5356-1:2004 EN ISO 14971:2012 EN ISO 15223-1:2012 8.5 Bluetooth LE Wireless Technology information Bluetooth LE Wireless Technology Information Modulation Type GFSK Max.
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