Masimo EMMA Operator's Manual
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Masimo EMMA Operator's Manual

Capnograph
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  • Page 1 Operator's Manual ® EMMA Capnograph...
  • Page 3 General knowledge of capnography and an understanding of the features and functions of EMMA are prerequisites for its proper use. Do not operate EMMA without completely reading and understanding these instructions.
  • Page 4 Patents: www.masimo.com/patents.htm ®, and Masimo® are federally registered trademarks of Masimo Corporation. EMMA™ and XTP™ are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. © 2019 Masimo Corporation www.masimo.com Masimo...
  • Page 5 Contents About this Manual ------------------------------------------------------------------------------------------------------ 5 Product Description, Features and Intended Use ------------------------------------------------------------------- 7 Safety Information, Warnings and Cautions ------------------------------------------------------------------------ 9 Chapter 1: Technology Overview ------------------------------------------------------------------------------------ 13 Chapter 2: Description ------------------------------------------------------------------------------------------------- 17 Chapter 3: Setting Up ------------------------------------------------------------------------------------------------ 19 Chapter 4: Operation ------------------------------------------------------------------------------------------------- 25 Chapter 5: Alarms and Messages ----------------------------------------------------------------------------------- 35 Chapter 6: Troubleshooting ----------------------------------------------------------------------------------------- 39 Chapter 7: Specifications ---------------------------------------------------------------------------------------------- 41...
  • Page 7 This manual explains how to set up and use EMMA® Capnograph. Important safety information relating to general use of EMMA appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes.
  • Page 9 Product Description, Features and Intended 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.
  • Page 11 WARNING: EMMA Airway Adapters shall not be reused. Reuse of single use Adapters can cause cross infection. WARNING: Do not use the EMMA Adult/Pediatric Airway Adapter with infants as the Adapter adds 6 ml dead space to the patient circuit.
  • Page 12 CAUTION: Remove alkaline batteries when the EMMA will not be in use for more than 30 days to avoid damage to the device due to batteries that may leak.
  • Page 13 Note: The presence of ambient air (0% CO ) 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.
  • Page 14 CAUTION: EMMA Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous waste. Note: This device complies with part 15 of the FCC Rules. 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.
  • Page 15 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.
  • Page 16 1 Spectrometer with optical filter wheel and infrared detector 2 Infrared light beam 3 Infrared light source 4 Respiratory gas www.masimo.com Masimo...
  • Page 17 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.
  • Page 19 This chapter contains the description of the EMMA physical features. General System Description The EMMA system includes the following: • EMMA Device • Two (2) AAA Batteries For a complete list of compatible EMMA Airway Adapters, visit www.masimo.com. www.masimo.com Masimo...
  • Page 20 7 Power On button 2 Battery Cover release 8 EMMA Airway button Adapter 3 Lanyard attachment 9 Alarm Status 4 Alarm Silence button 10 Respiratory Rate Value 5 EtCO2 Value 11 Battery Status 6 Capnogram Indicator 12 EMMA Sensor Body www.masimo.com Masimo...
  • Page 21 This chapter contains information about setting up EMMA before use. Installing Batteries Unpack and inspect the EMMA for external damage. Please contact your local distributor in case of damage. Press the Battery Cover release button into the EMMA Sensor Body until the Battery Cover pops off.
  • Page 22 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. www.masimo.com...
  • Page 23 Connecting to a Tube or Mask The EMMA Capnograph can be connected to a patient using an endotracheal tube or mask. The following pictures illustrate these two methods of connection. Endotracheal tube Mask www.masimo.com Masimo...
  • Page 24 Power On To power on EMMA, press the Power On button. When the EMMA Capnograph is ready the EtCO Value displays “0” and the Respiratory Rate Value displays dashes “- -“. www.masimo.com Masimo...
  • Page 25 The audible alarm sound may be checked by detaching the EMMA Airway Adapter to generate a No Adapter alarm. If the EtCO Value is non-zero, ensure that there has not been an accumulation of CO between the EMMA Sensor Body and the EMMA Airway Adapter by removing and reattaching the EMMA Airway Adapter.
  • Page 27 Chapter 4: Operation The information in this chapter assumes that EMMA is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate EMMA without completely reading and understanding these instructions.
  • Page 28 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.
  • Page 29 (Battery OK or Weak). When batteries are low, the Battery Status Indicator starts blinking. Battery Status Battery Voltage* Battery Status Indicator >2.4V Weak 2.2V to 2.4V www.masimo.com Masimo...
  • Page 30 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.
  • Page 31 Controls The EMMA Capnograph has one Power On and one Alarm Silence button. These buttons are also be used for adjusting the high and low EtCO alarm limits up and down. 1 Power On/Adjust Down button 2 Alarm Silence/Adjust Up button www.masimo.com...
  • Page 32 The adjustment ranges for the EtCO alarm limits are as follows: Lower range Upper range EtCO (mmHg) OFF; 1 – 89 mmHg 11 – 99 mmHg; OFF EtCO (kPa) OFF; 0.1 – 8.9 kPa 1.1 – 9.9 kPa; OFF www.masimo.com Masimo...
  • Page 33 10 mmHg (1.0 kPa) between the high and low alarm limit. If no buttons have been activated for a short period of time during alarm limit adjustment, the EMMA Capnograph will automatically resume normal operation.
  • Page 34 EMMA Capnograph will indicate this setting by showing "- -" on the EtCO 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. www.masimo.com Masimo...
  • Page 35 It is possible to switch off the high EtCO alarm by adjusting the limit above 99 mmHg (9.9 kPa). The EMMA Capnograph will indicate this setting by showing "- -" on the EtCO display during the adjustment routine.
  • Page 37 Chapter 5: Alarms and Messages 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. See Controls on page 29.
  • Page 38 = 0 at t = 20 t = 40, 60, 80, ... Alarm Alarm Priority: Low Alarm Priority: Low Alarm Priority: Medium No Breath (((•))) (((•))) (((•))) (((•))) (((•))) (((•))) Low EtCO High EtCO Clogged Adapter (((•))) www.masimo.com Masimo...
  • Page 39 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. www.masimo.com Masimo...
  • Page 40 Note 1: EtCO value displays momentary CO during No Breath. Note 2: RR value displays "- -" steady if no breath at all detected from power on. Note 3: Perform Zeroing procedure. See Zeroing Procedure on page 56. www.masimo.com Masimo...
  • Page 41 Adapter needs to be installed. Airway Adapter on page 20. Clogged Adapter alarm is Indicates that the EMMA Airway Replace the EMMA Airway Adapter with a new one. displayed Adapter needs to be replaced with a new one. A zero point adjustment is required. Perform a Zeroing procedure. See Zeroing Zero point adjustment Procedure on page 56.
  • Page 42 See Chapter 8: accuracy Service and Maintenance on page 53. • Automatic brightness control Numbers appear dim Pressing any button will return the EMMA display is activated. to normal brightness. See Controls on page 29. • Exposed to bright lights or sunlight.
  • Page 43 Range 0 mmHg to 99 mmHg 0-40 mmHg ± 2 mmHg, 41-99 mmHg 6% of reading during standard conditions Range 0 kPa to 9.9 kPa 0-5.3 kPa ± 0.3 kPa, 5.4-9.9 kPa 6% of reading during standard conditions www.masimo.com Masimo...
  • Page 44 Capacity - Alkaline [5] Approx. 5 hours Capacity - Lithium L92 [5] Approx. 10 hours Environmental Environmental Conditions -5 to +50°C (23 to 122°F) Operating Temperature -20 to -5°C for 20 minutes [6] Storage/Transport Temperature -40 - +70°C (-22 to 158°F) www.masimo.com Masimo...
  • Page 45 50 - 120 kPa Physical Characteristics Physical Characteristics Dimensions 52 mm x 39 mm x 39 mm (2.1” x 1.6” x 1.6”) Weight Approx. 65 g (2.1 oz.) with batteries Display Type 96 x 96 pixel RGB OLED-display www.masimo.com Masimo...
  • Page 46 Compliance Safety Standards Compliance EN 60601-1:2006/AMD1:2013 EN ISO 80601-2-55:2018 EN 60601-1-2:2015 EN ISO 5356-1:2015 EN 60601-1-8:2007, C1:2010, A1:2013 EN ISO 14971:2012 EN 60601-1-12:2015 EN ISO 15223-1:2016 Equipment Classification per IEC 60601-1 Type of Protection Internally powered (Battery power) www.masimo.com Masimo...
  • Page 47 IP44, Protection from tools and small wires greater than 1mm and from liquid ingress water spray from any direction. Mode of Operation Continuous operation Sterility No part of EMMA is sterile Additional Specifications General Specifications Description Compact, battery powered, quantitative capnograph for mainstream CO monitoring of adult, pediatric and infant patients.
  • Page 48 Surface Temperature 23°C / 73°F 30°C / 86°F 50°C / 122°F 57°C / 135°F Data Output Specifications Breath Detection Adaptive threshold, minimum 1kPa CO change. Adult/Pediatric Dead space 6 ml, Flow resistance < 0,3 cm H2O (@ 30 LPM) www.masimo.com Masimo...
  • Page 49 In operation and full accuracy within 15 seconds. Warm-up time after storage at -40°C A warm up period of 15 minutes is required before EMMA is ready for use after being stored with batteries mounted at −40°C when the ambient temperature is 20°C.
  • Page 50 Guidance and Manufacturer's Declaration-Electromagnetic Emissions EMMA is expected to be used in a professional environment like intensive care unit, patient room and operating suite except near high frequency electro surgical equipment and magnetic resonance imaging (MRI) systems. EMMA is also intended to be used in emergency medical services as road ambulances.
  • Page 51 This section constitutes the guidance and Masimo’s declaration regarding electromagnetic immunity for EMMA. Essential performance of EMMA is gas measurement accuracy (see Citation [4]) including gas reading alarm conditions, or generation of technical alarm conditions, when exposed to the following immunity levels.
  • Page 52 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the EMMA. Otherwise, degradation of the performance of the EMMA could result.
  • Page 53 Caution: Federal law restricts this device to sale IP44 solid foreign objects. by or on the order of a licensed physician. Instructions/Directions for Use/Manuals are available in electronic format @http://www.Masimo.com/TechDocs Note: eIFU is not available in all countries. www.masimo.com Masimo...
  • Page 54 Citations [1] The EMMA Capnograph displays CO in partial pressure units (kPa or mmHg) and compensates the displayed value for the actual barometric pressure. The EtCO value is the max partial CO pressure measured within a breath and the displayed value is: –...
  • Page 55 CAUTION: Do not immerse EMMA in any liquid. CAUTION: Do not apply excessive pressure on the IR-windows. Note: Before cleaning EMMA, remove the batteries and make sure the battery cover is re-attached correctly. To clean EMMA, follow the instructions below: Remove the Airway Adapter.
  • Page 56 Airway Adapters The EMMA Airway Adapters are not intended to be cleaned. 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.
  • Page 57 Insert two new AAA type batteries into the battery compartment. Make sure that the batteries are fitted according to the polarity marking. When the batteries are properly fitted, gently snap the battery cover back into place. Note: Always carry spare batteries in the EMMA pouch. www.masimo.com Masimo...
  • Page 58 Code When the Service value “0” is shown, zeroing of the EMMA is complete.* * The EMMA Capnograph will return to normal measuring mode when the Service value has reached "0" or if any of the buttons are released. www.masimo.com...
  • Page 59 Gas Span Check The EMMA Capnograph does not require any routine calibration. A gas span check is recommended at regular intervals to make sure the measurement is within accuracy levels. The suggested interval for gas span check is once every year.
  • Page 60 If the unit is reading within the above range then your EMMA Capnograph has been successfully verified. If the unit is not reading within the above range, disconnect the EMMA Airway Adapter from the gas cylinder and perform a Zeroing procedure and then repeat the Gas span check procedure. See Zeroing Procedure on page 56. If verification still fails, contact your local distributor for further instructions.
  • Page 61 Service and Return Procedure Contact Masimo for product support. If needed, an RMA will be provided for repair or replacement. Masimo can be reached at 800-326-4890. For customers outside the United States, local contact information can be found at http://service.masimo.com.
  • Page 62 Masimo; (e) used with other products, like new sensors, reprocessed sensors, or other accessories, not intended by Masimo to be used with the Product; (f) not used or maintained as provided in the operator’s manual or as otherwise provided in its labeling; (g) reprocessed, reconditioned, or recycled;...
  • Page 63 Product. Additionally, Masimo will not be liable for any incidental, indirect, special, or consequential loss, damage, or expense arising from the use or loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software.
  • Page 64 Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo's prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included.
  • Page 66 300513/LAB-10320B-0919...

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