Aisys CS² Et Control option Users Reference Manual Sw Rev 12 April 2022

User responsibility Datex-Ohmeda, Inc. a General Electric Company, doing business as GE Healthcare. This product will perform in conformity with the description thereof contained in this User’s Reference manual and accompanying labels and/or inserts, when assembled, operated, maintained, and repaired in accordance with the instruction provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest DatexOhmeda Customer Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without the prior written approval of Datex-Ohmeda. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda.

CAUTION

U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A., check the local laws for any restriction that may apply.

Table of Contents Et Control option Information... 2 Indications for use...2 Training... 2 Et Control setup and connections... 3 Symbols used in Et Control mode... 5 Et Control display... 6 Using Et Control... 7 Starting Et Control... 8 Stopping Et Control...8 Changing Et Control settings using quick keys... 8 Vaporizer settings and output... 9 Washing agent out of the system... 11 Turning agent off during Et Control...11 Purging agent during Et Control... 11 Et Control log... 13 Viewing Et Control log... 13 Et Control alarms... 14 Et Control error conditions... 15 Et Control troubleshooting... 16 Et Control Checkout troubleshooting... 18 Et Control parts... 19 CARESCAPE airway module... 19 Et Control theory of operation... 20 Safety mechanisms... 22 Et Control system check...22 Et Control leak check... 22 Et Control fresh gas sample check...23 Et Control supervisor... 23 Et Control increased flow... 23

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Et Control option Et Control algorithm and controller range... 25 Et Control mode examples... 26 Fresh gas control example... 26 Entering Et Control mode example... 27 Target values change example...28 Target values achieved example... 28 Typical agent delivery in Et Control cases... 29 Desflurane case clinical trial example... 31 Isoflurane case clinical trial example... 34 Sevoflurane case clinical trial example... 37 Et Control performance data... 41 Et Control factory default settings... 44 Fresh gas control settings... 45 System pneumatic circuit... 46 Super user... 48

Index

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Et Control option Et Control option

This addendum describes the function of Et Control mode. Use this addendum along with the product User’s Reference manual. The clinician sets the target end tidal O2 (EtO2) and target anesthetic agent (EtAA) values. The system monitors the EtO2 and EtAA values and adjusts the gas composition and total flow to maintain the set target values. The clinician prescribes and sets the dose target EtAA and EtO2 values for the patient based on the appropriate drug labeling and his or her clinical judgment. The Et Control feature does not provide dosing guidance or alter the dose that is prescribed by the clinician. A patient airway (for example, endotracheal tube or laryngeal mask airway) must be in place and controlled while using Et Control mode. Et Control mode cannot be used with a mask airway. Et Control can be used in vent mode (mechanical ventilation) or bag mode (manual ventilation) as long as a patient airway is in place and ventilation meets the patient gas demand. Irregular ventilation patterns in bag mode involve increased risk for automatic exit of Et Control to Fresh Gas Control. The system must have a supply of O2 and balance gas to enter Et Control mode. Safety checks run on the system while in Et Control mode. See "Et Control theory of operation" for specific check information. Et Control cannot be used with halothane, enflurane, non-circle circuit, cardiac bypass, Alternate O2, and Air only modes. It is recommended that Et Control mode not be used during cases that have disturbances to the lungs such as chest surgery.

WARNING

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The system may deliver 100% O2 while in Et Control mode. Do not use Et Control if delivery of 100% O2 could injure the patient.

•

Fire hazard. Do not use electrosurgical equipment that cannot be used in the presence of oxygen while in Et Control mode.

•

Et Control mode stops if an anesthetic agent type change is made while Et Control mode is active. Exit Et Control mode before changing an agent type.

•

Et Control mode repeatedly enters the increased flow state if a mask airway is used for the case and/or if the case has disturbances to the lungs such as chest surgery.

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Et Control option

Information Indications for use The optional Et Control feature is designed to interface with the Aisys CS2 Anesthesia System to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The Et Control feature is indicated for patients, 18 years of age and older.

Training A GE approved training curriculum is provided for all US customers who use Aisys CS2 with Et Control. All users are required to complete the training curriculum which includes passing a knowledge assessment prior to the use of Aisys CS2 with Et Control.

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Et Control setup and connections WARNING

Anesthetic agent can enter the room air due to a patient circuit leak or disconnection while Et Control mode is in use. The system requirements to use Et Control mode include: • • •

•

•

Et Control option must be installed and enabled on the system. For CARESCAPE airway modules, a D-fend Pro must be installed in the airway module. Either no agent cassette installed in the system or an agent cassette properly installed in the system. Agent cassette type must be desflurane, sevoflurane, or isoflurane. Measured CO2 respiratory rate (RR) must be 35 breaths per minute or less. The system must be registering a minute volume. The specified airway module requirements must be met.

Airway module requirements for Et Control mode: • • •

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Module type must be E-sCAiOE or E-sCAiOVE. Module must be installed and warmed up. Module must be properly calibrated.

Note

Use of airway modules E-series (E-CAiO, E-CAiOV, E-CAiOVX) or M-series (M-CAiO, M-CAiOV, M-CAiOVX) does not comply with IEC 60601-1-2:2014 standard.

Note

Proper connection of the fresh gas sample line is verified during the Full Test. A message displays in the test window if the test fails.

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Et Control option

1 6 5

4

3

1. 2. 3.

Airway module Gas sampling line Airway adapter with sampling line connector

4. 5. 6.

AB.75.259

2

Sample gas return port Fresh gas sample port D-fend Pro

Figure 1 • CARESCAPE airway module setup with Et Control mode

4

Note

The preoperative checkout looks for the presence of an Et Control compatible airway module. A message displays in the checkout menu if the airway module is not present.

Note

When the Airway Module D-fend Pro water trap fills with water it can cause an alarm that transitions the system to the Et Control Increased Flow mode. To clear the alarm, drain/remove water from the D-fend Pro and reconnect D-fend Pro to Airway Module.

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Symbols used in Et Control mode Symbols replace words on the equipment, on the display, or in product manuals. Warnings and Cautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual. Warnings tell about a condition that can cause injury to the operator or the patient. Cautions tell about a condition that can cause damage to the equipment. Read and follow all warnings and cautions. .

O2% indicator on left and balance gas indicator on right when in Et Control mode. Colors associated with gas settings.

Gas indicator when in Et Control mode. Color associated with gas settings.

Enhanced temperature sensing when in Et Control mode.

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Et Control option

Et Control display 20:55

15 9

6

3

500

Et Control

1

2

5

50 1 15.0

0.50

3.3 0.6

14

5.1

50

55 2

Et Control: O2 + Air + AA Et Des

0.50

3.0

l/min

4

Et Control AB.75.287

50

Min Flow

3

1.

Waveform field

Displays waveforms of measured values. For example, when in Et Control mode, this displays measured CO2 with Et Control.

2.

Measured value field

Displays measured values. For example: Gases.

3.

Measured value field

Displays measured values. For example: Agent.

4.

Et Control settings

Displays the buttons used for Et Control mode. For example: Et O2, Min Flow, EtDes, Et Control, and Gas Setup.

5.

Vaporizer output

Displays the measured value of agent output.

6.

Electronic gas flow indicator

Displays the measured value of total gas flow.

Figure 2 • Et Control view

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Using Et Control Use the Et Control menu to start, stop, and resume Et Control mode. Use the gas quick keys to adjust the Et Control settings. Return to fresh gas delivery at any time. Important

Rapid increases of desflurane concentrations have been associated with sympathetic activation. Et Control achieves the target settings quickly. The response time that Et Control takes to achieve the target settings is constant (not user adjustable). This behavior is intended to provide a similar response time for a wide range of patients and a variety of target setting changes. The target settings may be achieved in steps if a slower wash in is desired. For example, if a target EtDes of 6.0% is the desired end target setting, set the first target to 2.0%, then 4.0%, and ultimately 6.0%.

Note

The maximum value within the "Et Control algorithm and controller range" (Des 18%, Iso 5%, Sev 8%) may be delivered in Et Control. The actual values inspired by the patient (FiAA) and expired by the patient (EtAA) will be considerably lower as the agent is diluted in the circuit. The Et Control algorithm is specified to not allow the measured EtAA value to overshoot the user set Target EtAA by more than 0.2 MAC or 30% of setting (whichever is greater). This ensures there is not a significant increase above the clinicians’ desired values. When the user set Target EtAA value is achieved, the vaporizer setting is then lowered to maintain the user set Target EtAA value.

7.0%

6.0%

5.0%

4.0%

1 3.0%

2.0%

0.0%

2

1. 2. 3. 4.

AB.75.296

3 4

1.0%

Measured EtAA Time Step Quick

Figure 3 • Steps to target EtAA

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Et Control option

Starting Et Control WARNING

Ensure that alarm limits are appropriate for the patient before starting Et Control. If the alarm settings are incorrect a condition that requires immediate action by the user to prevent harm to the patient may not be recognized. 1. 2.

3. Note

Select Et Control. Select Start. The target EtO2 and target EtAA are set to the current measured Et values. Gas flows and agent delivery adjusts as needed to meet target EtO2 and target EtAA. The target EtAA quick key is highlighted. Confirm or adjust and confirm the target EtAA setting. If the conditions to enter Et Control are not met, instructions show in the help window to resolve conditions to allow Et Control mode.

Stopping Et Control 1. 2.

Select Et Control. Select Stop. Fresh gas control mode resumes at values based on the target Et O2 and target EtAA settings. The agent quick key is highlighted.

3.

Confirm or adjust and confirm the agent setting.

Changing Et Control settings using quick keys Gas quick keys while in Et Control mode show the target EtO2%, minimum flow l/min, and target EtAA%. Adjust these settings by pushing the corresponding quick key. Note

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If target EtO2 is set to Max, the fresh gas is 100 % O2 and anesthetic agent is added and pushed to the circle breathing system. The measured EtO2 is less than 100 % because other gases (CO2 and agent) are present in the exhaled gas. If the measured EtO2 falls below 80 %, flows increase to attempt to maintain that level of EtO2.

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1. 2. 3.

Select the quick key to select the corresponding setting. Turn the ComWheel to the desired value. Push the ComWheel or select the quick key to confirm the change. After adjusting EtAA%, an estimated MAC (MACe) value is shown on the quick key. This is the corresponding age MAC adjusted value for the adjusted EtAA value. This estimated value is based on the current N2O value.

Note

Vaporizer settings and output

1

18% 17% 16% 15% 14% 13% 12% 11% 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0%

3 4 5 6 0

5

10

15

20

25

30

35

40

45

50

AB.75.302

The graphs below show the Vaporizer setting from the controller at common Total Flow values used by Et Control. The Vaporizer Output shown on the Split Screen is the liquid anesthetic agent (ml/h) in use.

50 100 150 200 250 300 350 400

2

1. 2. 3.

Vaporizer setting from controller Vaporizer output on split screen (ml/h) Total flow: 0.3 l/min

4. 5. 6.

Total flow: 0.5 l/min Total flow: 2.0 l/min Total flow: 6.0 l/min

Figure 4 • Desflurane Vaporizer Setting (%) And Vaporizer Output On Split Screen (ml/h)

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Et Control option

5%

4%

3%

1

3 4 5 6

1%

0%

0

1

2

3

4

5

6

7

8

9

10 11 12 13 14 15 16 17 18 19 20 20

40

60

80

AB.75.303

2%

100

2

1. 2. 3.

Vaporizer setting from controller Vaporizer output on split screen (ml/h) Total flow: 0.3 l/min

4. 5. 6.

Total flow: 0.5 l/min Total flow: 2.0 l/min Total flow: 6.0 l/min

Figure 5 • Isoflurane Vaporizer Setting (%) And Vaporizer Output On Split Screen (ml/h)

8% 7% 6% 5%

1

4%

3 4 5 6

2% 1% 0%

0

2

4

6

8

10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 40

60

80

100

120

140 160

AB.75.304

3%

180

2

1. 2. 3.

Vaporizer setting from controller Vaporizer output on split screen (ml/h) Total flow: 0.3 l/min

4. 5. 6.

Total flow: 0.5 l/min Total flow: 2.0 l/min Total flow: 6.0 l/min

Figure 6 • Sevoflurane Vaporizer Setting (%) And Vaporizer Output On Split Screen (ml/h)

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Washing agent out of the system Turning agent off during Et Control Use the Off setting in the target EtAA quick key to shut agent Off. This is equivalent to turning the vaporizer off without changing the fresh gas flow. When turning off the vaporizer, the anesthetic agent concentration will slowly decrease based on the fresh gas flow. Et Control: O2 + Air + AA Et Sev

2.00

Off

l/min

Et Control

AB.75.297

50

Min Flow

Target %

Figure 7 • EtAA Off quick key

1. 2.

Select the target EtAA quick key. Select Off. Agent delivery stops. No additional agent is added to the breathing system. Flows are controlled based on oxygen and balance gas concentrations.

Purging agent during Et Control Use the Purge setting in the target EtAA quick key to drive agent out of the system as fast as possible.

50

Min Flow

Et Sev

2.00

Purge

l/min

Et Control

Target %

AB.75.298

Et Control: O2 + Air + AA

Figure 8 • EtAA Purge quick key

WARNING

Do not remove the agent cassette while the target EtAA is set to Purge. Removing the agent cassette causes the target EtAA to set to Off, resulting in slower removal of agent out of the system. 1. 2.

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Select the target EtAA quick key. Select Purge. Agent delivery stops.

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Et Control option Fresh gas flow is set at 10 l/min.

3 4

2

1. 2. 3. 4.

AB.75.295

1

Measured EtAA Time Purge Off

Figure 9 • Purge versus off

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Et Control log Use the System Setup menu to access the Et Control log. A record of the Et Control mode actions during a case can be viewed in the Et Control log. The log records date, event, target EtAA%, AA flow ml/h, EtAA%, target EtO2%, mixer O2%, EtO2%, minimum flow, total flow, Air or N2O, and Des, Sev, or Iso. Entries are saved at event change. The log is capable of displaying up to 19 entries at a time with at least 2500 entries total. The log is cleared at the start of a case. When system power is shut off or lost, data from the most recent case is saved.

Viewing Et Control log 1. 2. 3. 4.

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Select System Setup. Select Et Control Log. Select Scroll, Next Page, First Entry, Last Entry, or the cursor to scroll through the current log page. Select Close to exit the Et Control Log.

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Et Control option

Et Control alarms .

Message

Priority

Cause

Et Control stopped. Adjust settings.

Medium

Multiple possible causes. Safeguard the patient. Verify that the gas delivery settings are appropriate. Go to the Et Control menu to view the actions needed to resolve the alarm.

Push Et Control. Flow is Medium 6 l/min.

Multiple possible causes. Safeguard the patient. Go to the Et Control menu to view the actions needed to resolve the alarm.

Sample line leak. Check Medium sample line

Leak detected in the airway module sample line.

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Action

Check the airway module sample line connections. Replace the sample line if condition continues. Go to the Et Control menu. Select Resume Flow Control to restart Et Control.

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Et Control error conditions The following error conditions cause an automatic exit from Et Control to Fresh Gas Control: • • • • • • • • • • Note

Alternate O2 mode active O2 or Air pipeline pressure is invalid O2, Air or N2O pipeline pressure is low Airway Module data missing or invalid Selectable Common Gas Outlet (SCGO) failure Ventilator Failure active Vaporizer Failure active Invalid agent cassette detected Halothane or Enflurane agent cassette detected Multiple agent types detected

The measured end-tidal value of the secondary agent must be greater than 0.35 MAC Age for automatic exit to occur. • • • • •

Cardiac Bypass mode active Non-Circle mode active Et Control Fresh Gas Sample Check failure Et Control Supervisor failure Et Control Internal Error

The following error conditions will cause the software to transition to Et Control increased flow state: • • • • • • • • • • •

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Measured CO2 RR is greater than 40 Measured CO2 RR is less than 6 No CO2 breaths detected for a period of time High FiCO2 detected Airway Module sample gas out blocked Airway Module sample line blocked Airway Module sample line disconnected Airway Module sample line leak Unknown agent detected Et Control System Check failed Et Control Leak Check failed

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Et Control option

Et Control troubleshooting Use the help information shown in the Et Control help window to resolve Et Control alarms. Select Et Control to access the Et Control help window. .

Help message

Symptom

Problem

Solution

Use Fresh Gas Control. Start Et Control when previous agent is removed from the circuit.

Et Control has stopped Et Control does not during an agent function during an agent change. change.

Et Control requires sufficient gas supply pressure.

Et Control has stopped. The O2 and/or the balance The O2 and balance gas pipeline Gas supply pressure gas supply pressures are pressures must be more than 252 kPa (36 alarms occur. out of the allowable range psi). The O2 and balance gas cylinder for Et Control. pressures must be more than 2633 kPa (381 psi). Check that the pipelines and cylinders are properly connected. Use fresh gas control until the gas supply pressures are within the allowable range. Re-enter Et Control.

Et Control requires a Fresh Gas Module. Check gas module connections.

Et Control has stopped. The fresh gas module Help information shows used with E and M-series fresh gas module is airway modules has required. become disconnected.

Check that the fresh gas module is properly connected. If the condition continues, contact an authorized service representative.

Use Fresh Gas Control. Calibrate gas module when possible.

Et Control has stopped. The fresh gas sample Help information check failed. indicates Fresh Gas Sample Check failure.

Check the airway module sample line for kinks. After the case, calibrate the airway module. If multiple failures occur following an airway module calibration, contact an authorized service representative.

During an agent change, use fresh gas control mode until the previous agent is cleared out of the system before restarting Et Control mode. Use fresh gas control until previous agent registers less than 0.35 MAC. Re-enter Et Control.

Target settings not Et Control has stopped. Target EtO2 and/or target achieved. Use Help information EtAA was not achieved. Fresh Gas Control. indicates Et Control supervisor failure.

The case conditions may not allow the use of Et Control. If multiple failures occur under different case conditions, contact an authorized service representative.

Enter Et Control again.

Et Control has stopped. Multiple possible causes. Help information indicates enter Et Control again.

Re-enter Et Control. If issue continues, finish the case using fresh gas control. Contact an authorized service representative.

Sample line leak. Check sample line. Then select Resume Flow Control to continue with low flows.

Flow is 6 l/min during Leak detected in the Check the airway module sample line Et Control. Help airway module sample line. connections. Replace the sample line if information indicates a condition continues. Select Resume Flow sample line leak. Control to restart Et Control.

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