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ETCO2 Sensor User Manual

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.
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.
Device description

Model

Description

Application patient

Compatible Monitor

CTM-RP01

Mainstream/Respironics/3.0M

>3kg

GENERAL MEDITECH, INC., Model: G3C
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%

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)

Installation & Usage

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)

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:

All components are Latex free.
All dimensions are in millimeters.
Color pigment does not alter the specifications of the material
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.

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

Selecting a Sensor:
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.
Connect the combined CO2 flow sensor to the patient breathing circuit.

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

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

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.
Shelf life
3 years
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.
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).
Waste Disposal
Please refer to your local laws and regulations for information on how to dispose of ETCO2 sensors.

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

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

Model	Description	Application patient	Compatible Monitor
CTM-RP01	Mainstream/Respironics/3.0M	>3kg	GENERAL MEDITECH, INC., Model: G3C