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ETCO2 Sensor User Manual


  1. Intended Use & Indications for Use
    The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia or recovery, in the intensive care unit (ICU), and in emergency medicine, transport or respiratory care facility.

  2. Measurement Principle
    The ETCO2 sensor uses an infrared absorption (IR) technique for monitoring CO2. The principle is based on the fact that CO2 molecules absorb infrared light energy at specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When the IR light beam is passed through a gas sample containing CO2, an electronic signal from the photodetector can be obtained.

     CAUTION
    U.S. federal law restricts this device to sale by or on the order of a physician.

  3. Device description

    Model

    Description

    Application patient

    Compatible Monitor

    CTM-RP01

    Mainstream/Respironics/3.0M

    >3kg

    GENERAL MEDITECH, INC., Model: G3C

     

  4. Operation and Storage environment
    1. Operation environment: Temperature: 5 to +40°C, Humidity: 10 to 85%
    2. Storage environment: Temperature: -25 to +55°C, Humidity: 10 to 85%

  5. Performance

    Performance

    Parameter

    Measurement Technique

    Non-dispersive infrared (NDIR) spectroscopy

    CO2 Measurement Range

    0 to 150 mmHg, 0 to 19.7%

    CO2 Resolution

    0.1 mmHg 0 to 69 mmHg 

    0.25 mmHg 70 to 150 mmHg

    CO2 Accuracy

    0 - 40 mmHg ± 2 mmHg

    41 - 70 mmHg ± 5% of reading

    71 - 100 mmHg ± 8% of reading

    101 - 150 mmHg ± 10% of reading

    Above 80 breath per minute ±12% of reading

    * NOTE: Gas temperature at 25°C

    Respiration Rate Range

    0 to 150 breaths per minute (bpm)

    Respiration Rate Accuracy

    ± 1 breaths per minute (bpm)

    Voltage Requirements

    5.0 VDC ±5%

    Interconnection

    Lemo Redel 8-pin

    Temperature and Humidity

    Operating: 0 to 40°C, 15 to 85% RH, non-condensing

    Storage: -10 to 40°C, <90% RH, non-condensing

    Water Resistance

    IPX2 – Splash-proof (sensor head only)

     

  6.  Installation & Usage
    1. Connecting the CTM-RP01 CO2 Sensor to the Patient Monitor
      1. Insert the CTM-RP01 CO2 Sensor connector into the receptacle of the host monitor as shown in Figure 1.


        (Figure 1)

      2. Make sure the arrows on the connector are at the top of the connector and line up the two keys of the connector with the receptacle and insert.
      3. To remove the connector, grasp the body portion of the connector back and remove.
        Note: Do not remove by pulling cable.

      Shown below is the CTM-RP01 CO2 Sensor connection to a CO2 adapter in Figure 2.

      The CTM-RP01 is compatible only with Respironics Novametrix mainstream CO2 airway adapters.


      (Figure 2)

      Shown below is the CTM-RP01 CO2 Sensor with a patient circuit in Figure 3:


      (Figure 3)

    2. CO2 Adapters
      For monitoring CO2, select an airway adapter based on the patient and monitoring situation. Airway adapter taper meets ISO 5356-1 standard.

      Pediatric/Adult Single Patient Use Airway Adapter

      • Catalog No. 6063
      • For intubated patients with endoctracheal tube diameters greater than 4 mm
      • Adds 5 cc of deadspace
      • Weight: 7.7 grams
      • Pressure drop: 0.40 cmH2O @ 60 LPM
      • Color: Clear

       

      Pediatric/Adult Single Patient Use Airway Adapter

      • Catalog No. 6312
      • For intubated patients with endoctracheal tube diameters less than or equal to 4 mm
      • Adds less than 1 cc of deadspace
      • Weight: 9.1 grams
      • Pressure drop: 0.74 cmH2O @ 10 LPM
      • Color: Purple

      Pediatric/Adult Reusable Airway Adapter

      • Catalog No. 7007
      • For intubated patients with endoctracheal tube diameters greater than 4 mm
      • Adds 5 cc of deadspace
      • Weight: 12.0 grams
      • Pressure drop: 0.38 cmH2O @ 60 LPM
      • Color: Black

       

      Pediatric/Adult Single Patient Use Airway Adapter

      • Catalog No. 7053
      • For intubated patients with endoctracheal tube diameters less than or equal to 4 mm
      • Adds less than 1 cc of deadspace
      • Weight: 14.9 grams
      • Pressure drop: 0.68 cmH2O @ 10 LPM
      • Color: Red

       

      Note:

      1. All components are Latex free.
      2. All dimensions are in millimeters.
      3. Color pigment does not alter the specifications of the material
      4. The adapters can be connected to anesthesia, ventilator, or BIPAP/CPAP masks for non-intubated patients.

      Attach the CTM-RP01 CO2 sensor to the monitor and adapter as described above.

    3. Patient Connections

      Combined CO2/Flow Sensor Identification Table

      Pediatric/Adult Combined CO2/Flow Sensor

      • Catalog No. 6719
      • For intubated patients with endoctracheal tube diameters greater than 5.5 mm
      • Adds 8 cc of deadspace
      • Weight: 9.8 grams
      • Pressure drop: 2.1 cmH2O @ 60 LPM
      • Color: Clear

       

       

      Pediatric Combined CO2/Flow Sensor

      • Catalog No. 6716
      • For intubated patients with endoctracheal tube diameters of 3.5-6.0 mm
      • Adds less than 4 cc of deadspace
      • Weight: 10.5 grams
      • Pressure drop: 2.1 cmH2O @ 30 LPM
      • Color: Green

       

       

      Neonatal Combined CO2/Flow Sensor

      • Catalog No. 6720
      • For intubated patients with endoctracheal tube diameters of 2.5-4.0 mm
      • Adds less than 1 cc of deadspace
      • Weight: 9.6 grams
      • Pressure drop: 3.1 cmH2O @ 10 LPM
      • Color: Purple

       

       

      Material: Sensor Body – Polycarbonate, Tubing – PVC, Connector – ABS Plastic

      Note:

      1. All components are Latex free.
      2. All dimensions are in millimeters.
      3. The weight is for the sensor only. Does not include the tubing or connector.
      4. Color pigment does not alter the specifications of the material.
      5. The adapters can be connected to anesthesia, ventilator, or BIPAP/CPAP masks for non-intubated patients.

      1. Selecting a Sensor:
      2. Connect the Combined CO2/Flow sensor to the host flow input receptacle.


        Note: Always insert the connector into the receptacle before inserting the combined CO2 flow sensor into the circuit. 



      3. Connect the combined CO2 flow sensor to the patient breathing circuit.

  7. Alarm limits, ranges and default settings
    Refer to the user’s manual of the CO2 monitor intended to be used with ETCO2 Sensor.
  8. Interfering gas and vapor effects

    Gas or Vapor

    Gas Level

    Quantitative Effects

    Nitrous oxide

    60

    No additional effect

    Halothane

    4

    No additional effect

    Enflurane

    5

    No additional effect

    Isoflurane

    5

    No additional effect

    Sevoflurane

    5

    No additional effect

    Xenon

    80

    CO2 value at 38 mmHg, the maximum negative bias Poor 5 mmHg

    Helium

    50

    No additional effect

    Metered dose inhaler propellants

    Unspecified

    Unspecified

    Desflurane

    15

    CO2 value at 38 mmHg, the maximum positive bias Poor 3 mmHg

    Ethanol

    0.1%

    No additional effect

    Isopropanol

    0.1%

    No additional effect

    Acetone

    0.1%

    No additional effect

    Methane

    1%

    No additional effect

     

  9. Cleaning & Disinfecting
    • Unplug the sensor before cleaning or disinfecting.
    • Dip clean the sensor (not the connector) in a mild detergent solution or a 70% isopropy alcohol solution. If low-level disinfection is required, use a 1:10 bleach solution.
    • Rinse the sensor (not the connector) in water, wipe it with a dry cloth and leave to dry completely.
       CAUTION
      Do not sterilize by irradiation steam or ethylene oxide. 

  10. Shelf life
    3 years

  11. Warranty
    Cables and Sensors offers a one-year warranty against defects in material or workmanship from the date of purchase. Orantech does not cover the damage or breakage due to the abusive use or negligent care of the sensor.

    Cables and Sensors guarantees that the equipment conforms to the specifications of the safety and performance standards currently in force and applicable to it.

  12. Warning
    • Before using the sensor, confirm that the unit has been zeroed out. This might need to be performed manually. Non-zeroing may result in incorrect readings.
    • Sensors are designed for use with specific monitors.
    • The operator is responsible for checking the compatibility of the monitor, sensor and cable before use.
    • Incompatible components can result in degraded accuracy and performance.
    • Consult the operation instructions for the equipment and the related accessories before operating equipment to ensure their compatibility.
    • Portable and mobile RF communication equipment can affect equipment.
    • Refer to your local laws and regulations for information on how to dispose of sensor.
    • Do not use the sensor during MRI scanning. Conducted current may cause burns. Also, the sensor may affect the MRI image, and the MRI unit may affect the sensor’s accuracy.
    • Do not immerse the sensor or the sensor’s connector ends in cleaning solution(s).

     

  13. Waste Disposal
    Please refer to your local laws and regulations for information on how to dispose of ETCO2 sensors.

  14. Accessories
    The ETCO2 sensor is compatible only with Respironics mainstream CO2 airway adapters as indicated below:

    Accessory

    Description

    Airway Adapters

    PN: 6063, Single-Patient Use Adult Airway Adapter

    PN: 6421, Single-Patient Use Adult Airway Adapter with Mouthpiece

    PN: 6312, Single-Patient Use Infant Airway Adapter

    PN: 7007, Reusable Adult / Pediatric Airway Adapter

    PN: 7053, Reusable Infant Airway Adapter

    CO2 Mainstream Monitoring Mask

    PN: 9960PED, CAPNO2mask - pediatric

    PN: 9960STD, CAPNO2mask - adult standard

    PN: 9960LGE, CAPNO2mask - adult large



  15. Symbol Explanation
    Manufacturer
    Catalog number
    Batch code
    Series number
    Gas input
    Gas output
    Latex-free
    Non-sterilized
    See instructions
    Caution
    Date of manufacture
    Crossed out wheelie bin indicates separate treatment from general waste at end of life.
    Waste of Electrical and Electronic Equipment Directive (WEEE)
    Protection against moisture
    U.S. federal law restricts this device to sale by or on the order of a physician.
    European Authorized Representative
    CE Mark
    Type BF Equipment