CARESCAPE Respiratory Modules E-sCAiOVE User Manual Aug 2014

Due to continuing product innovation, specifications in this manual are subject to change without notice. For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc. and GE Healthcare Finland Oy.

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CARESCAPE respiratory modules

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Contents About this manual... 5 CARESCAPE respiratory modules’ indications for use... 5 Intended use of this manual... 5 Intended audience of this manual ... 5 Training requirements... 5 Manufacturer responsibility... 5 Related documents ... 6 Safety precautions ... 6 Safety message signal words... 6 Disposal and storage warnings... 6 Disposal and storage cautions... 6 Module overview ... 7 System compatibility... 7 CARESCAPE respiratory module parameters ... 7 About the measurements... 8 CARESCAPE respiratory module connectors ... 9 Airway gases measurement... 9 Airway gases equipment to patient connections with CARESCAPE respiratory modules ... 9 Setting up the airway gases measurement ... 10 Airway gases warnings... 10 Airway gases cautions ... 12 Scavenging ... 12 Airway gases points to note ... 13 Airway gases troubleshooting... 13 Patient Spirometry measurement... 14 Patient Spirometry equipment to patient connection ... 14 Preparing the Patient Spirometry measurement ... 14 Patient Spirometry warnings ... 15 Patient Spirometry cautions ... 15 Patient Spirometry points to note ... 15

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Patient Spirometry troubleshooting... 16 Gas exchange measurement... 16 Gas exchange equipment to patient connection... 16 Gas exchange warnings ... 17 Gas exchange cautions ... 18 Gas exchange measurement limitations... 19 Gas exchange points to note ... 19 Gas exchange troubleshooting ... 19 Cleaning and care... 20 D-fend Pro(+) water trap ... 21 Reusable D-lite and Pedi-lite sensor cleaning instructions ... 21 Calibration warnings... 21 Airway gas calibration ... 21 Patient Spirometry calibration... 22 System compatibility ... 22 Supplies and accessories ... 23 Gas accessories ... 23 Patient Spirometry and gas exchange accessories... 27 Technical specifications... 29 Physical characteristics ... 29 Operating characteristics ... 29 Airway gases specifications ... 30 Patient Spirometry specifications ... 33 Gas exchange specifications... 34

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About this manual CARESCAPE respiratory modules’ indications for use The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.

Intended use of this manual This manual is to be used with the user documentation of the patient monitor. Pay special attention to all generic safety statements and safety symbols listed in the monitor’s user documentation.

Intended audience of this manual This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices and terminology required to provide patient care. Using the device should never replace nor impede the human intervention and required patient care provided by clinical professionals.

Training requirements No product-specific training is required for the use of these modules.

Manufacturer responsibility GE is responsible for the effects on safety, reliability, and performance of the equipment only if:

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Assembly operations, extensions, readjustments, modifications, servicing, or repairs are carried out by authorized service personnel.

●

The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

●

The equipment is used in accordance with the instructions for use.

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Related documents The module may be used with multiple host devices. Always check with the host device's user manual for additional information. There are two separate technical manuals for the respiratory modules providing information about installing, maintaining, and servicing the modules: ● One for modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, and E-sCAiOVX used with

monitoring host devices ● One for modules E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, and E-sCAiOVE used in the

anesthesia systems Avance CS2 or Aisys CS2. If the E-sCAiOE or E-sCAiOVE module is used in a patient monitor, also refer to the E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE specific technical manual for instructions on how to perform the module fresh gas branch leak test in connection with preventive maintenance and after servicing the module.

Safety precautions Safety precautions given in this manual apply to the CARESCAPE respiratory modules. For generic system-level safety statements, refer to the monitor’s user documentation. For accessory-specific statements, refer to their own instructions for use.

Safety message signal words Safety message signal words designate the severity of a potential hazard. DANGER

Indicates a hazardous situation that, if not avoided, will result in death or serious injury.

WARNING

Indicates a hazardous situation that, if not avoided, could result in death or serious injury.

CAUTION

Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

NOTICE

Indicates a hazardous situation not related to personal injury that, if not avoided, could result in property damage.

Disposal and storage warnings WARNING

DISPOSAL. At the end of their service life, the products described in this manual, as well as their accessories, must be disposed of in compliance with the guidelines regulating the disposal of each product. If you have any questions concerning disposal of a product, please contact GE or its representatives.

Disposal and storage cautions General cautions This symbol is identified by a white background, black triangular band, and a black symbol.

CAUTION

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PACKAGING DISPOSAL. Dispose of the packaging material, observing the applicable waste control regulations.

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CAUTION

STORAGE AND USE. Do not use or store equipment outside the specified temperature, humidity, or altitude ranges.

Module overview System compatibility The CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, and E-sCAiOVE can be used for respiratory monitoring in the following host systems: ●

CARESCAPE Monitor B850

●

CARESCAPE Monitor B650

●

CARESCAPE Monitor B450

●

B40 Patient Monitor (2060600-002)

●

Aisys CS2

●

Avance CS2

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S/5 Anesthesia Monitor, software version L-ANE06(A) 24.1 or later

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S/5 Critical Care Monitor, software version L-ICU06(A) 24.1 or later

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S/5 Compact Anesthesia Monitor, software version L-CANE 05(A) 19.6 or later

●

S/5 Compact Critical Care Monitor, software version L-CICU 05(A) 19.6 or later

NOTE

Low sample gas flow situation is indicated with the message Replace D-Fend in the L-xxx06(A) software versions 24.1 and L-xxx05(A) software versions 19.6.

NOTE

The CARESCAPE respiratory modules cannot be used in the S/5 Extension Frame.

NOTE

The Neonatal Intensive Care Unit (NICU) software package of the CARESCAPE modular patient monitors may not support the use of CARESCAPE respiratory modules.

NOTE

Displayed data (including but not limited to TV, MV, RR, Raw and N2O), trends and alarms may vary depending on the host device. Specifications listed represent the capabilities of the modules. Always check the host device’s user manual for additional information.

NOTE

The following modules are considered identical and cannot be used in the same system at the same time: E-CO, E-sCO, E-COV, E-sCOV, E-COVX, E-sCOVX, E-CAiO, E-sCAiO, E-sCAiOE, E-CAiOV, E-sCAiOV, E-sCAiOVE, E-CAiOVX, E-sCAiOVX, E-miniC, N-CAiO, N-FC, N-FCREC.

CARESCAPE respiratory module parameters The CARESCAPE respiratory modules use the sidestream method to measure the airway gas concentrations, and optionally Patient Spirometry. The following table shows the parameters measured by different modules. The x indicates that the module measures the parameter referred to in the column heading.

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Anesthetic agents

Module

Agent ID

Patient Spirometry

CO2

N2O

O2

E-sCO

x

x*

x

E-sCOV

x

x*

x

x

E-sCOVX

x

x*

x

x

E-sCAiO

x

x

x

x

x

E-sCAiOE

x

x

x

x

x

E-sCAiOV

x

x

x

x

x

x

E-sCAiOVX

x

x

x

x

x

x

E-sCAiOVE

x

x

x

x

x

x

Gas exchange

Aisys CS2 end-tidal control

x x x x

* N2O is not displayed by all host devices.

For more information on the use of the end-tidal control, refer to the Aisys CS2 user documentation.

About the measurements The CARESCAPE respiratory modules draw a 120 ml/min flow of sampled gas through the gas sampling line and water trap to the gas sensors. CO2, N2O, and anesthetic agent concentrations are measured with an infrared absorption sensor, and the O2 concentration with a paramagnetic sensor. The module finds the time instant of the highest CO2 concentration in each breath. Concentration at that instant is the ET CO2 reading. Because nitrous oxide and anesthetic agents are measured by the same sensor as CO2, the ET readings of those gases are obtained directly at the time instant of ET CO2. For calculating ET readings of oxygen, the module synchronizes the O2 waveform with the CO2 waveform. The ET reading of O2 is then determined as O2 concentration at the time instant of ET CO2. If no breaths are detected for a given time (20 s, for example), an apnea situation is triggered. During apnea, the ET values are updated every two seconds to the current concentration of each gas. The infrared sensor also identifies the anesthetic agent and mixtures of two anesthetic agents in the sampled gas. The module has a gas exhaust port that can be connected to a scavenging system. With the E-sCOV, E-sCOVX, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE modules you can also monitor airway pressures, flow, volumes, compliance and resistance, breath-by-breath. The measurement is taken using the pressure sensors in the module. The sensors are connected to the patient’s airway with a double lumen spirometry line that conducts pressures from the D-lite(+)/Pedi-lite(+) spirometry sensor to the module. The respiratory volumes are calculated from the flow data, and the airway compliance and resistance are calculated from both the airway pressure and flow values. The E-sCOVX and E-sCAiOVX modules also measure gas exchange parameters VCO2 and VO2. For instructions on how to use the airway gases and Patient Spirometry measurements, see the host device’s user documentation.

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CARESCAPE respiratory module connectors

1.

Patient Spirometry keys (Save Loop, Change Loop)

2.

Water trap release/locking latch

3.

Gas sample, sampling line connector on the water trap

4.

Water trap container

5.

Connectors for Patient Spirometry tubes

6.

Connector for fresh gas used in end-tidal control. For more information on the use of the end-tidal control, please refer to the Aisys CS2 user documentation.

7.

Gas exhaust, connector for the gas exhaust line

NOTE

Only qualified service personnel may remove the protecting screw from the fresh gas connector and attach the fresh gas sample tubing.

Airway gases measurement Airway gases equipment to patient connections with CARESCAPE respiratory modules

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CARESCAPE respiratory module

2.

Gas sample, gas sampling line connector on the water trap

3.

Gas sampling line

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4.

Gas sampling line connector on the airway adapter; place the connector upwards

5.

Airway adapter with sampling line connector

6.

Heat and moisture exchanger with filter (HMEF) (optional)

Setting up the airway gases measurement 1.

Make sure that the water trap container is empty and properly attached.

2.

Connect the gas sampling line to the sampling line connector on the water trap.

3.

Connect the sample gas outlet to gas scavenging if N2O or volatile agents are used.

4.

Turn on the monitor or connect the module to the monitor. The monitor performs a self-check for the module when the module is connected. Automatic agent identification is activated in those modules that have this feature.

5.

Wait until the message Calibrating or Calibrating gas sensor disappears before connecting the sampling line to the airway adapter or the airway adapter to the ventilator circuit.

6.

Connect the sampling line to the airway adapter or the airway adapter to the ventilator circuit. Position the adapter with the sampling port upwards to minimize the amount of condensed water possibly entering the sampling line.

7.

Check that the airway adapter connections are tight and that the adapter is operating properly.

NOTE

Check that the sample line is connected to the water trap before connecting the module to the monitor or turning on the monitor.

NOTE

To minimize the amount of dust drawn into the gas sampling system, always keep the water trap connected to the module. When gas measurement is not in use, you can disconnect the module from the monitor to eliminate the operating sound of the gas pump.

Airway gases warnings General warnings This symbol is identified by a yellow background, black triangular band, and a black symbol.

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WARNING

Always inspect the airway adapter for a tight connection and proper operation before attaching it to the patient.

WARNING

Leaks in the gas sampling circuit (water trap and sampling line) may cause inaccurate readings.

WARNING

Remove the airway sampling line from the patient’s airway while nebulized medications are being delivered.

WARNING

Handle the water trap and its contents as you would any body fluid. Infectious hazard may be present.

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WARNING

Since sample gas may contain anesthetic agents, make sure that it is not released in the room. Connect exhaust to a scavenging system to prevent exposure to anesthetic agents.

WARNING

Strong scavenging suction may cause excessive sample gas flow and inaccurate gas readings.

WARNING

Route all tubing away from the patient’s throat to avoid strangulation.

WARNING

To avoid the spread of infectious disease, do not allow the exhaust to discharge in the direction of the patient or user.

WARNING

EtCO2 values may differ from blood gas readings.

WARNING

Do not use a CO2 module at the same time as a multi-gas module.

WARNING

When using the CARESCAPE respiratory modules with volume controlled ventilation at low tidal volumes, the specified gas withdrawal rate may significantly reduce the amount of gas delivered to the patient.

WARNING

Make sure to compensate for the possible reduction of tidal volume caused by the 120 ml/min gas sample flow.

WARNING

A failure in zeroing or calibrating airway gases may cause inaccurate readings.

WARNING

Make sure that the module is always in vertical position when used.

WARNING

Since calibration gas contains anesthetic agents, always ensure sufficient ventilation of the room during calibration.

WARNING

Always ensure the correct size and fit of accessories according to patient type and application, especially when monitoring pediatric and neonatal patients. The size and fit of accessories may impact the measured gas concentration values at low tidal volumes. It is recommended to have the gas sampling port close to the proximal end of the endotracheal tube. Excessive dead space in the circuit, including the accessories, may cause re-breathing of gases. Very low accessory dead space between the breathing circuit Y-piece and the gas sampling site may impact the measured gas concentration due to dilution of the sampled exhaled gas with fresh gas from the ventilator. To confirm accurate correlation with measured gases and blood, check arterial blood gas values to confirm a suitable setup is used.

WARNING

EQUIPMENT FAILURE OR INACCURATE READINGS. Planned maintenance should be carried out annually according to the instructions given in the technical manual. Failure to implement the recommended maintenance schedule may cause equipment failure or inaccurate readings.

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WARNING

PATIENT CROSS-INFECTION. Returning the sampled gas to the patient circuit causes a risk of patient cross-infection.

WARNING

PATIENT CROSS-INFECTION. Always use a bacterial breathing system filter proximal to the patient when returning the sampled gas to the patient circuit. If a bacterial breathing system filter is not used, a failure in the D-Fend Pro water trap may cause a risk of patient cross-infection.

WARNING

PATIENT CROSS-INFECTION. If the sampled gas is returned to the patient circuit, ensure the protective function of the D-Fend Pro water trap by replacing it at least once a week, or immediately in case of a defective or missing bacterial breathing system filter. Otherwise, there is a risk of patient cross-infection.

Airway gases cautions CAUTION

Never connect the loose end of the gas sampling line to the Patient Spirometry connector as this may break the spirometry unit. The Patient Spirometry connector is meant for the Patient Spirometry tube only.

CAUTION

Do not apply pressurized air or gas to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.

Scavenging Preventing operating room pollution When N2O and volatile anesthetics are used, prevent operating room pollution by connecting the sample gas outlet (gas exhaust) of the module to the scavenging system.

Scavenging through the ventilator reservoir 1.

Connect an exhaust line to the sample gas outlet (gas exhaust) on the module's front panel.

2.

Attach the other end of the line to the ventilator reservoir. Make sure that the reservoir tube diameter is at least 2 to 3 times larger than the exhaust line.

Scavenging through the anesthesia gas scavenging system Anesthesia machines are equipped with an anesthesia gas scavenging system (AGSS), and in some machines you can connect the sample gas outlet directly to it. See the anesthesia machine's user documentation to find out where and how the sample gas can be connected.

Connecting directly to the scavenging system

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1.

Connect the exhaust line to the module's sample gas outlet.

2.

Connect the exhaust line only to an open scavenging system where gas is removed at room pressure.

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NOTE

Do not connect the module directly to a strong vacuum scavenging system.

Returning sampled gas to the patient circuit Returning sampled gas to the patient circuit causes a risk of patient cross-infection. To prevent patient cross-infection always use a bacterial breathing system filter proximal to the patient. Ensure the protective function of the D-Fend Pro water trap by replacing it at least once a week, or immediately in case of a defective or missing bacterial breathing system filter. 1.

Connect the exhaust line to the module's gas outlet.

2.

Connect the exhaust line to the patient circuit.

NOTE

Refer to the anesthesia machine’s documentation to find out where and how the sample gas can be returned.

Airway gases points to note ●

Use GE anesthesia sampling lines (PE/PVC) when anesthetic agents are used. If no anesthetic agents are present, you can use GE CO2 sampling lines (PVC)

●

Make sure that you are using the D-fend Pro or D-fend Pro+ water trap.

●

Empty the water trap container as soon as it is more than half full. With a sample gas temperature of 37°C, a room temperature of 23°C, and sample gas relative humidity of 100 %RH, the water trap should be emptied every 24 hours (applies when the sample gas flow is within 120 ± 20 ml/min).

●

When using an HMEF filter, place it between the patient and airway adapter.

●

Place the airway adapter between the HMEF and Y-piece.

●

Place the airway adapter in 45° tilt and all ports upwards to prevent condensed water from entering the adapter interior and the tubing

●

Always check the tightness of all connections.

●

Make sure that the gas sampling line is properly connected to the water trap and the water trap is properly connected to the airway gas module. Gas leaks in these connections may dilute the gas sample from the patient circuit, thus resulting in erroneous gas readings. During normal operation, all sampled gas flows out of the sample gas outlet. Room air is used as reference gas for the oxygen measurement and it is mixed with the sampled gas. The sampled gas is diluted by room air so that the fraction of room air in the exhaust gas is about 20%.

Airway gases troubleshooting Problem

Solution

Airway gas values seem too low

● Check the sampling line and connectors for

leakage. ● Check the patient status. ● Check the arterial blood gas values.

Airway gas values seem too high

● Check the sampling line for blockage. ● Check the patient status. ● Check the arterial blood gas values.

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Problem

Solution

Module does not work

● Check and clean the filter if necessary. ● Check the water trap and water trap connectors.

Liquid may have entered the module. Replace the module and have it checked by authorized service personnel. No airway gas values

● Check that the gas sampling line is connected to

the water trap.

Patient Spirometry measurement Patient Spirometry equipment to patient connection

1.

E-sCOV, E-sCOVX, E-sCAiOV, E-sCAiOVX, or E-sCAiOVE module

2.

Gas sample, gas sampling line connector on the water trap

3.

Gas sampling and spirometry tubes

4.

D-lite/Pedi-lite sensor, or D-lite+/Pedi-lite+ sensor for humid conditions

5.

Gas sampling line connector

6.

Heat and moisture exchanger with filter (HMEF)

Preparing the Patient Spirometry measurement

14

1.

Take a new Patient Spirometry tube and connect the tube to the D-lite(+)/Pedi-lite(+) sensor by inserting the angle connectors in the sensor connectors. Place all D-lite(+)/Pedi-lite(+) ports upwards with approximately a 45 °C tilt to prevent condensed water from entering the sensor interior and the tubings.

2.

Connect the other end of the Patient Spirometry tube to the pressure connectors on the module.

3.

Connect a gas sampling line to the Luer connector on the other side of the D-lite(+)/Pedi-lite(+) sensor.

4.

Connect the other end of the gas sampling line to the sampling line connector on the module’s water trap.

5.

Make sure that the connections are tight.

6.

Select the correct sensor type.

7.

Connect the D-lite(+)/Pedi-lite(+) between the Y-piece and the intubation tube in the breathing circuit.

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Patient Spirometry warnings General warnings This symbol is identified by a yellow background, black triangular band, and a black symbol.

WARNING

The presence of Helium or Xenon in the breathing circuit causes incorrect measurement values.

WARNING

Make sure you select the correct sensor type for the patient: D-lite(+) for adult patients, Pedi-lite(+) for pediatric patients. Also check the sensor type selection in the host device.

Patient Spirometry cautions CAUTION

Never connect the loose end of the gas sampling line to the Patient Spirometry connector as this may break the spirometry unit. The Patient Spirometry connector is meant for the Patient Spirometry tube only.

CAUTION

Do not apply pressurized air or gas to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.

Patient Spirometry points to note

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Place an HME/HMEF/filter between the D-lite(+)/Pedi-lite(+) sensor and the patient.

●

Disconnect the HME/HMEF/filter and D-lite(+)/Pedi-lite(+) during nebulization of medications.

●

The flow measurement should be calibrated once a year or when there is a permanent difference between inspiratory and expiratory volume. For further information, see the modules technical manual.

●

Using a cuffless intubation tube may affect Patient Spirometry readings due to potential leakages around the endotracheal tube.

●

When anesthetic agents are used, use a module with anesthetic agent (Ai) identification option.

●

The flow and volume measurement of the CARESCAPE respiratory module is compensated for the density of the gas which is important for measurement accuracy with heavy molecules of anesthetic agents like Desflurane. However, using high concentrations of anesthetic agents may still affect flow and tidal volume readings. In this case, the CARESCAPE respiratory module tends to underestimate flow and volume.

●

Depending on the type of patient circuit used, the temperature and humidity inside the D-lite flow sensor vary between dry ambient temperature air and 100% humid 37 °C air. As the CARESCAPE respiratory module needs to convert the measured volume/flow to ATPD or BTPS conditions, it needs to assume the temperature and humidity of the gas that flows through the flow sensor. By default the module assumes conditions equivalent to an HME patient circuit. If active humidification is used, the module will therefore overestimate the measured volume/flow by approx. 5%. For some host devices you can select the type of patient circuit used, and in this case the remaining error is minimized.

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●

When using active humidification, there might be condensation in the D-lite flow sensor affecting flow and volume readings. In this case, the CARESCAPE respiratory module tends to overestimate flow and volume.

Patient Spirometry troubleshooting Problem

Solution

Values seem erroneous

● Check the patient status. ● Check that you are using the correct sensor type:

D-lite(+) for adult patients, Pedi-lite(+) for pediatric patients. ● Check the sensor type selection. ● Check that the Patient Spirometry tube connectors

and their connections are tight and not leaking. ● Check the arterial blood gas values. ● Check that the sampling line is not kinked.

Values seem unstable

● Remove the D-lite(+)/Pedi-lite(+) and shake drops

away. ● Check that the connectors on the

D-lite(+)/Pedi-lite(+) are intact and that connections are tight. Strong vibrations in the loop

● Check the patient status. ● Check the patient and system for water or

secretions.

Gas exchange measurement Gas exchange equipment to patient connection The equipment to patient connections for gas exchange are similar to those of Patient Spirometry but there are also some connection-related issues to be noted. Only the modules E-sCAiOVX and E-sCOVX measure gas exchange.

Gas exchange patient connections with HME/HMEF

NOTE

16

Always place the HME/HMEF between the D-lite(+) sensor and the patient.

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NOTE

By-pass flow together with long expiration flow pause time may disturb the measurement. Consider using shorter expiration time to diminish the effect. In addition, you may use a suitable spacer with a 5 to 10 ml dead space (e.g., a straight T-adapter) between the Y-piece and D-lite(+)/Pedi-lite(+). The by-pass flow effect may exist even in an adult setting, but it is more emphasized when monitoring pediatric patients and using the Pedi-lite(+).

Gas exchange patient connections with flexible tube

NOTE

Place all D-lite ports upwards with a 20° to 45° tilt to prevent condensed water from entering the sensor interior and the tubings.

NOTE

When monitoring pediatric patients with tidal volumes less than 300 ml, use the Pedi-lite(+) sensor. Remember to select the sensor type accordingly.

Gas exchange warnings Before using the gas exchange measurement, familiarize yourself with safety precautions related to airway gases and Patient Spirometry measurements as they apply to the gas exchange measurement also. General warnings This symbol is identified by a yellow background, black triangular band, and a black symbol.

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WARNING

The presence of Helium or Xenon in the breathing circuit causes incorrect measurement values.

WARNING

Make sure you select the correct sensor type for the patient: D-lite(+) for adult patients, Pedi-lite(+) for pediatric patients. Also check the sensor type selection in the host device.

WARNING

If the expiration gas flow during the end phase of the patient’s expiration is close to zero for more than two seconds before the next inspiration starts, the ventilator’s bypass flow may affect the measurement.

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WARNING

INACCURATE READINGS. As the gas exchange parameters are calculated from O2, CO2, and airway flow data, any conditions affecting the accuracy of these parameters will also affect the accuracy of gas exchange parameters. To avoid the risk of inaccurate gas exchange readings that may result in compromised patient safety, adhere to the given measurement guidelines for O2, CO2, and airway flow measurements and check that these measurements are functioning properly.

WARNING

INACCURATE READINGS. The following conditions affect the accuracy and performance of the gas exchange measurement: ● A leaking airway. ●

The use of a sampling line other than a 2–meter non-nasal sampling line.

●

The use of high FiO2.

●

The fluctuation of the delivered FiO2 level during inspiration.

The use of N2O in ventilation. ● High pressure variation from PEEP to Ppeak.

●

The use of Helium or Xenon in ventilation. ● High respiration rates. ●

●

The use of high frequency ventilation (HFV).

●

The use of bi-level positive airway pressure (BiPAP).

●

Irregular airway flow pattern.

●

High bias flow, especially when using ventilation settings resulting in periods with no airway flow.

●

Irregular CO2 amplitude.

If these conditions are present, there is a risk of inaccurate readings, which may result in compromised patient safety. WARNING

INACCURATE READINGS. Increased inspiratory dead space in breathing systems without expiratory by-flow through the Y-piece may cause too large VCO2 and VO2 readings. To avoid any risk to the patient, always take this into account when interpreting the measurement results with such breathing systems.

Gas exchange cautions General cautions This symbol is identified by a white background, black triangular band, and a black symbol.

18

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CAUTION

Never connect the loose end of the gas sampling line to the Patient Spirometry connector as this may break the spirometry unit. The Patient Spirometry connector is meant for the Patient Spirometry tube only.

CAUTION

Do not apply pressurized air or gas to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.

Gas exchange measurement limitations ●

This measurement is not available in the NICU software package.

●

Only the E-sCAiOVX and E-sCOVX modules measure gas exchange.

NOTE

Routine calibration checks are required to ensure the measurement accuracy.

Gas exchange points to note ●

Gas exchange measurement is for intubated patients only.

●

Use only 2-meter (7-ft) gas sampling lines. Using other lines may cause inaccurate readings.

●

FiO2 delivery from the ventilator side should be stable.

●

High PEEP or ventilating pressures may activate a message prompting to check the water trap. In this case, you may consider decreasing the PEEP if possible.

●

To ensure measurement accuracy, check the accuracy of airway gas measurement every two months: feed calibration gas mixture to the monitor in the normal operation mode (without entering the calibration menu) and check that the readings on the monitor match those on the calibration gas bottle. If they do not match, calibrate airway gases.

●

When anesthetic agents are present, use the E-sCAiOVX module for monitoring airway flow and gas exchange.

●

Any acute change in alveolar ventilation will be immediately reflected in CO2 output, which will not measure the metabolic production of CO2 until a new steady state has been achieved. The time required for the stabilization varies widely and ranges from 30 to 120 minutes.

Gas exchange troubleshooting Problem

Solution

Gas exchange values are too low.

● Check the sampling line and connectors for

leakage. Gas exchange values seem unreliable.

● Check the ventilation settings. ● Check the inspired oxygen concentration and

correct if necessary (max. 85%). ● Check that pressure variation from PEEP to Ppeak

is not too high. ● Check the Patient Spirometry data to ensure that

flow measurement is functioning properly.

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Problem

Solution ● If the expiration gas flow during the end phase of

the patient’s expiration is close to zero for more than two seconds before the next inspiration starts, the ventilator’s bypass flow may affect the measurement. You can reduce this effect by adding a suitable spacer with a 5 to 10 ml dead space (e.g., a straight T-adapter) between the Y-piece and the D-lite or the Pedi-lite adapter. Module does not work.

● Check and clean the filter if necessary. ● Check the water trap. If it was too full, liquid may

have entered the module. Replace the module and have it checked by authorized service personnel. No gas exchange values.

● Check that the gas sampling line is not connected

to the sample gas out connector. VO2 values are non-physiologic.

● Verify that the oxygram curve is stable. ● Change the sampling line. ● Check the D-lite placement.

Are gas exchange values accurate with 100% oxygen?

No, gas exchange measurements are not possible when the FiO2 > 85%. This is also indicated on screen by the replacement of numbers by ---. Please also note that full measurement accuracy is obtained when FiO2 is less than 65%. Between 65% and 85% FiO2, the accuracy is reduced to +/-15%

Can the gas exchange modules be used with active humidification?

Yes, they can. Use the D-lite+/Pedi-lite+ flow sensor for humid conditions. If HME is used, both the D-lite/Pedi-lite and D-lite+/Pedi-lite+ can be used.

Can the gas exchange modules be used with pediatric patients?

Yes, for those pediatric patients whose respiration rate is below 35 breaths/minute. When monitoring pediatric patients, use the Pedi-lite sensor and select the sensor accordingly from the monitor menu.

How can I ensure that the VCO2 and VO2 values are correct?

Always make sure that you are using correct accessories and that the measurement setup and patient connections are correct.

Why does the RQ value rise above 1.0?

The physiological range of RQ is usually between 0.7 and 1.0. If the value is out of this range, check the measurement setup.

Why does the RQ value sometimes show unphysiological values such as RQ < 0.6?

Usually this is due to a non-steady state: the ventilator settings have been changed, FiO2 has changed, the ventilation is irregular.

Cleaning and care For detailed maintenance instructions, refer to the respiratory modules’ technical documentation.

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CARESCAPE respiratory modules

2082250-001