CARESCAPE Respiratory Modules Users Manual 13 edition

User's Manual

Contents

Contents About this manual... 5 CARESCAPE respiratory modules’ indications for use... 5 CE marking application year... 5 Intended use of this manual... 5 Intended markets of this manual... 6 Intended audience of this manual ... 6 Training requirements... 6 Naming conventions ... 6 Legal manufacturer information... 6 Manufacturer responsibility ... 6 Related documents ... 7 Safety precautions... 7 Safety message signal words... 7 Disposal and storage warnings ... 7 Disposal and storage cautions ... 7 Module overview... 8 System compatibility... 8 CARESCAPE respiratory module parameters ... 8 About the measurements ... 9 CARESCAPE respiratory module connectors ...10 Airway gas measurement... 10 Airway gases equipment to patient connections with CARESCAPE respiratory modules ...11 Setting up the airway gases measurement...11 Airway gases warnings ... 12 Airway gases cautions ... 14 Scavenging ... 14 Choosing the correct gas exhaust line...14 Preventing operating room pollution ...15 Scavenging through the ventilator reservoir ...15 Scavenging through the anesthesia gas scavenging system...15 Connecting directly to the scavenging system ...15 Returning sampled gas to the patient circuit ...15 Airway gases CO2 unit conversions ...16 Airway gases points to note... 16 Airway gases troubleshooting...17 Spirometry measurement ... 17 Spirometry equipment to patient connection...17 Preparing the spirometry measurement ...18 Spirometry warnings ... 18 Spirometry cautions... 18 Spirometry points to note ... 18 Water droplets in spirometry tubes...19 Removing water droplets from spirometry tubes ...19 Messages caused by water droplets in the spirometry tubing...20 2082250-001

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Spirometry troubleshooting ... 21 Gas exchange measurement... 21 Gas exchange equipment to patient connection...21 Gas exchange patient connections with HME/HMEF...22 Gas exchange patient connections with flexible tube...22 Gas exchange warnings... 22 Gas exchange cautions... 23 Gas exchange measurement limitations...24 Gas exchange points to note ...24 Gas exchange troubleshooting ...24 Cleaning and care ... 25 D-fend Pro water trap ... 25 Reusable D-lite and Pedi-lite sensor cleaning instructions...26 Calibration warnings... 26 Airway gas calibration... 26 Spirometry calibration ... 26 Supplies and accessories ... 26 Gas accessories ... 27 Spirometry and gas exchange accessories ...29 Calibration gases and regulators...30 Technical specifications... 30 Physical characteristics ... 30 Operating characteristics ... 30 Airway gases specifications... 31 Spirometry specifications... 33 Gas exchange specifications ... 35

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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, EsCAiOE, 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.

CE marking application year CE marking application year: • E-sCO, E-sCOV, E-sCAiO, and E-sCAiOV: 2012 • E-sCAiOE and E-sCAiOVE: 2013 • E-sCOVX and E-sCAiOVX: 2014

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. This manual is to be used with the following products: • E-sCO-00 • E-sCOV-00 • E-sCOVX-00 • E-sCAiO-00 • E-sCAiOV-00 • E-sCAiOVX-00 • E-sCAiOE-00 • E-sCAiOVE-00 NOTE Due to continuing product innovation, specifications in this manual are subject to change without notice.

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Intended markets of this manual This manual is not intended for U.S. FDA-regulated markets because certain supplies, accessories, and devices may not be cleared for use by the U.S. FDA.

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 system 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.

Naming conventions 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. In this manual, the following product names are used as generic terms: • CARESCAPE respiratory modules when referring to E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE • D-lite when referring to D-lite, D-lite+, and D-lite++ • Pedi-lite when referring Pedi-lite and Pedi-lite+ • D-fend Pro when referring to D-fend Pro and D-fend Pro+

Legal manufacturer information CARESCAPE™ Respiratory Modules

GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki Finland

Manufacturer responsibility GE is responsible for the effects on safety, reliability, and performance of the equipment only if: • 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. 6/38

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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. The technical manual provides information about installing, maintaining, and servicing the modules.

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 CAUTION PACKAGING DISPOSAL. Dispose of the packaging material, observing the applicable waste control regulations. CAUTION STORAGE AND USE. Do not use or store equipment outside the specified temperature, humidity, or altitude ranges.

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Module overview

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Module overview System compatibility The CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, EsCAiOE, and E-sCAiOVE can be used for respiratory monitoring in the following host systems: • CARESCAPE B850 • CARESCAPE B650 • CARESCAPE B450 • CARESCAPE Monitor B850 • CARESCAPE Monitor B650 • CARESCAPE Monitor B450 • B40(i) Patient Monitor • Patient Monitor B125 • Patient Monitor B105 • Patient Monitor B155M • Patient Monitor B125M • Patient Monitor B125P • Patient Monitor B105M • Patient Monitor B105P • Aisys CS2 • Avance CS2 • CARESTATION 620/650/650c/750/750c 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 spirometry. The following table shows the parameters measured by 8/38

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different modules. The x indicates that the module measures the parameter referred to in the column heading. Module

CO2

N2O

O2

Anesthet- Agent ID ic agents

Spirometry

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 endtidal 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. In addition to the measurements above, the E-sCOVX and E-sCAiOVX modules with gas exchange option enable monitoring of oxygen consumption (VO2), carbon dioxide production (VCO2), energy expenditure (EE), and respiratory quotient (RQ). For instructions on how to use the measurements, see the host device’s user documentation.

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CARESCAPE respiratory module connectors

1. 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 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 gas measurement The CARESCAPE respiratory modules enable monitoring of CO2, O2, N2O, and anesthetic agent concentrations. All parameters are not available with all modules. CO2, N2O, and anesthetic agent concentrations are measured with an infrared absorption sensor, and the O2 concentration with a paramagnetic sensor. NOTE When gas measurement is not in use, disconnecting the module from the monitor is recommended to avoid unnecessary stressing of the wearing parts inside the module.

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Airway gases equipment to patient connections with CARESCAPE respiratory modules

1. CARESCAPE respiratory module 2. Gas sample, gas sampling line connector on the water trap 3. Gas sampling line 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 when sampled gas is directed to the scavenging system) 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.

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.

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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 WARNING PATIENT SAFETY. Always inspect the airway adapter for a tight connection and proper operation before attaching it to the patient. WARNING ERRONEOUS READINGS. Leaks in the gas sampling circuit (water trap and sampling line) may cause inaccurate readings. WARNING WATER TRAP BLOCKAGE. Remove the airway sampling line from the patient’s airway while nebulized medications are being delivered. WARNING INFECTION HAZARD. Handle the water trap and its contents as you would any body fluid. Infectious hazard may be present. WARNING EXPOSURE TO ANESTHETIC AGENTS. 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 ERRONEOUS READINGS. Strong scavenging suction may cause excessive sample gas flow and inaccurate gas readings. WARNING STRANGULATION. Route all tubing away from the patient’s throat to avoid strangulation. WARNING INFECTION HAZARD. To avoid the spread of infectious disease, do not allow the exhaust to discharge in the direction of the patient or user. WARNING MISINTERPRETATION. EtCO2 values may differ from blood gas readings. WARNING PATIENT SAFETY. Do not use a CO2 module at the same time as a multi-gas module. WARNING PATIENT SAFETY. 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.

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WARNING PATIENT SAFETY. Make sure to compensate for the possible reduction of tidal volume caused by the 120 ml/min gas sample flow. WARNING ERRONEOUS READINGS. A failure in zeroing or calibrating airway gases may cause inaccurate readings. WARNING ERRONEOUS READINGS. Make sure that the module is always in vertical position when used. WARNING EXPOSURE TO ANESTHETIC AGENTS. Since calibration gas contains anesthetic agents, always ensure sufficient ventilation of the room during calibration. WARNING PATIENT SAFETY. 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. WARNING INACCURATE READINGS. To ensure the accuracy of gas measurement, perform regular calibration checks according to the instructions provided. Failing to do so may result in inaccurate readings and compromised patient safety. To avoid this risk, always adhere to the recommended calibration intervals. WARNING PATIENT CROSS-INFECTION. Returning the sampled gas to the patient circuit causes a risk of patient cross-infection. WARNING PATIENT CROSS-INFECTION. Sampled gas may be returned to the patient circuit only when using a bacterial breathing filter system proximal to the patient. In addition, the anesthesia machine must have a bacterial filter between the module gas output and patient circuit. Otherwise, there is a risk of patient cross-infection. NOTE To prevent patient cross-infection, have qualified service personnel verify that the anesthesia machine has a bacterial filter between the module gas output and the patient circuit.

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Airway gases cautions CAUTION EQUIPMENT DAMAGE. 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 EQUIPMENT DAMAGE. Do not apply pressurized air or gas to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.

Scavenging Choosing the correct gas exhaust line Make sure that you are using a gas exhaust line that is compatible with the module's gas exhaust connector. Prefixes SUA and SGV listed in this section refer to the first three characters in the serial number on the module device label. The following figures show the compatible gas exhaust lines for each connector. GE custom exhaust connector

1. Module with GE custom exhaust connector (prefix SUA in the serial number). Note that: • the connector does not have a collar around the male pin. • the diameter of the connector’s male pin is larger than with the Luer exhaust connector. 2. 5514184 Gas exhaust line, white conical, disposable, 2 m/6.6 ft for gas scavenging 3. With compatible GE Anesthesia Carestations: 5514182 Gas exhaust line, white conical and Colder, disposable, 1 m/3.3 ft or 5514183 Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in

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Luer exhaust connector

1. Module with Luer exhaust connector (prefix SGV in the serial number). Note that this connector has a distinct collar around the male pin. 2. M1031274 Exhaust line for gas return or scavenging 3. With compatible GE Anesthesia Carestations: 8004462 Exhaust line with Colder fitting 1 m (41 in) or 8004463 Exhaust line with Colder fitting, 18 cm (7 in)

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 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.

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, have qualified service personnel verify that the anesthesia machine has a bacterial filter between the module gas output and patient circuit. Always use a bacterial breathing system filter proximal to the patient when returning sampled gas to the patient circuit.

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

Airway gases CO2 unit conversions Respiratory gases are in contact with lungs and become saturated with water vapor. The module reports the patient gas concentrations relative to ambient pressure and temperature as if the patient gas was without water vapor in dry conditions (ATPD). The monitor can convert the ATPD CO2 partial pressures to be displayed in saturated water vapor conditions (BTPS). The module provides the measured atmospheric pressure for the monitor to convert ATPD to BTPS. Selecting Wet (BTPS) humidity compensation type activates calculations where the EtCO2 value is normalized to assume 100 %RH and 37 °C. Wet compensation is not done if EtCO2 is shown in %. For instructions on selecting Dry (ATPD) or Wet (BTPS) as the humidity compensation type, refer to the host device’s user documentation.

NOTE 47 mmHg is the partial pressure of the saturated water vapor at 37 °C. The following table lists the relationship between gas concentration and its partial pressure. The host device may display CO2 values differently depending on the gas setting (wet or dry). If applicable, see the host manual for changing this setting. Partial pressure

Gas concentration (%)

Reading in mmHg (dry gas)

(ambient pressure in mmHg * gas concentration in %)/100

Reading in mmHg (water vapor saturated gas)

((ambient pressure in mmHg – 47 mmHg) * gas concentration in %)/100

Reading in kPa (dry gas)

(ambient pressure in mmHg * gas concentration in %)/750

Reading in kPa (water vapor saturated ((ambient pressure in mmHg – 47 mmHg) * gas concentration in %)/750 gas)

Airway gases points to note • Disconnect the sampling line from the patient circuit while administering nebulized medication. • Use GE anesthesia sampling lines (PVC/PE) when anesthetic agents are used. • 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 a 20° to 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%. 16/38

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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.

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 qualified service personnel.

No airway gas values

• Check that the gas sampling line is connected to the water trap.

EtCO2 value is considerably higher than the CO2 partial pressure determined by blood gas analysis

• Gas sensor is measuring gases in dry (ATPD) conditions. Selecting wet (BTPS) humidity compensation type activates calculations where the EtCO2 value is normalized to assume 100 %RH and 37 °C. • Check the humidity compensation type from the host device settings.

Spirometry measurement With the E-sCOV, E-sCOVX, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE modules you can monitor gas measurement parameters and also airway pressures, flow, volumes, compliance and resistance, breathby-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.

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 With D-lite++: the sensor design and position of the gas sampling line differ from the above figure. 5. Gas sampling line connector 2082250-001

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6. Heat and moisture exchanger with filter (HMEF) NOTE Place all D-lite ports upwards with a 25° to 35° tilt to prevent condensed water from entering the sensor interior and the tubings.

Preparing the spirometry measurement 1.

Take a new spirometry tube and connect the tube to the D-lite(+)/Pedi-lite sensor by inserting the angle connectors in the sensor connectors. With D-lite++: the spirometry tubes and the sensor are fixed together so you can proceed directly to the next step.

2.

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

3.

Connect a gas sampling line to the gas sample connector of the D-lite/Pedi-lite sensor. With D-lite++: The gas sampling line is preconnected so you can proceed directly to the next step.

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.

8.

Place all D-lite/Pedi-lite ports upwards with approximately a 25° to 35° tilt to prevent condensed water from entering the sensor interior and the tubings.

Spirometry warnings WARNING ERRONEOUS READINGS. The presence of Helium or Xenon in the breathing circuit causes incorrect measurement values. WARNING PATIENT SAFETY. 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.

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

Spirometry points to note • Place an HME/HMEF/filter between the D-lite/Pedi-lite sensor and the endotracheal tube. 18/38

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• Disconnect the sampling line from the patient circuit while administering nebulized medication. • The flow measurement should be calibrated when there is a permanent difference between inspiratory and expiratory volume. For further information, see the modules’ service manuals. • Using a cuffless intubation tube may affect 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. • 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.

Water droplets in spirometry tubes Always check the spirometry tubes for water droplets. Water droplet(s) inside a spirometry tube can block the whole cross-section of the tube and cause erroneous measurement values. If a water droplet enters the module and wets a pressure sensor, the spirometry unit can fail. In this case, the host device displays an error message. A wetted pressure sensor can recover to its normal operation if it is allowed to dry for a few hours without connecting the spirometry tubes to the module. You cannot use spirometry and gas exchange measurements during this time. For humid conditions, GE recommends that you use the following flow sensors: • D-lite++ • Pedi-lite+

Removing water droplets from spirometry tubes NOTE With D-lite++, you cannot detach the spirometry tubes from the sensor. If you see water droplets inside the integrated spirometry tubes, replace the spirometry set. If you see water droplet(s) inside the spirometry tubes within the first 1 m (3.3 ft) from the D-lite(+) or Pedi-lite sampling sensor, remove the water droplets: 1.

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Detach the spirometry tubes from the D-lite(+) or Pedi-lite.

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2.

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Carefully shake the droplets off the tubes. NOTE Do not hit the connectors against any hard objects, as it can damage the connectors.

If you see water droplet(s) further than 1 m (3.3 ft) from the D-lite(+) or Pedi-lite sampling sensor, replace the spirometry tubes.

Messages caused by water droplets in the spirometry tubing If removing the water droplets according to the instructions does not resolve the problem, follow the suggested actions below. Message

Suggested actions

• Bx50: Artifact

• Check that you are using a 2–meter gas sampling tube and a spirometry tube with the gas exchange measurement.

• Other hosts: N/A

• Change the tube(s) if necessary. • Bx50: Bypass flow high

• Reduce the fresh gas flow.

• Other hosts: N/A • Bx50: Low volumes

• Replace the spirometry tubing.

• Other hosts: N/A

• D-lite or Pedi-lite: • Check that the correct sensor type (D-lite or Pedi-lite) has been selected from the monitor menu. • Check for any leaks.

• Bx50: MVexp << MVinsp

• Replace the spirometry tubing.

• Other hosts: N/A

• D-lite or Pedi-lite: Check for any leaks.

• Bx50: No VO2, FiO2>85%

• Use lower O2 concentrations.

• Other hosts: N/A • Bx50: No VO2, FiN20 too high

• Check that N2O is not used.

• Other hosts: N/A • Bx50: Out of range

• Check that the gas sampling line and spirometry lines are correctly connected to the airway and the gas module.

• Other hosts: N/A

• Check that the correct sensor type (D-lite or Pedi-lite) has been selected from the monitor menu. • Bx50: Sensor INOP

• Contact qualified service personnel.

• Aisys/Avance: Module fail. No CO2, AA, O2 data • B40(i): N/A • Bx50: Service gas module

• Contact qualified service personnel.

• Bx50: Service gas module - and specific error indication

• For more detailed error message information, refer to the service manual.

• Aisys/Avance: Module fail. No CO2, AA, O2 data • B40(i): N/A

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CARESCAPE respiratory modules

2082250-001

User's Manual

Gas exchange measurement

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 spirometry tube connectors and their connections are tight and not leaking. • Check the arterial blood gas values. • Check that the sampling line or spirometry tube are not kinked. • Check that there is no water in the spirometry tube.

Values seem unstable Strong vibrations in the loop

• 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. • Check the patient status. • Check the patient and system for water or secretions.

Gas exchange measurement In addition to airway gas and spirometry parameters, the E-sCOVX and E-sCAiOVX modules with gas exchange option enable monitoring of oxygen consumption (VO2), carbon dioxide production (VCO2), energy expenditure (EE), and respiratory quotient (RQ).

Gas exchange equipment to patient connection The equipment to patient connections for gas exchange are similar to those of spirometry but there are also some connection-related issues to be noted. Only the modules E-sCAiOVX and E-sCOVX measure gas exchange. NOTE Use only 2-meter (7-ft) gas sampling lines. Using other lines may cause inaccurate readings. NOTE CARESCAPE respiratory modules with gas exchange measurement has been optimized to function with a non-zero bias-flow (for example 2 l/min) from the ventilator during the expiration phase. The small gas sample flow rate of the CARESCAPE respiratory module adapts the metabolic measurement with the bias-flow, and the spacer between the Y-piece and D-lite/Pedi lite sensor is not required. However, to ensure the metabolic measurement when using a filter, connect the filter between the elbow adapter and the endotracheal tube. This prevents the high expiratory jet flow reaching the sampling port. NOTE Place all D-lite ports upwards with a 25° to 35° 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.

2082250-001

CARESCAPE respiratory modules

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