Maquet C300 User manual

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THE CS300

ABBREVIATED OPERATOR’S GUIDE

DATASCOPE IS NOW MAQUET CARDIOVASCULAR

Maquet C300 User manual

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CS300 Bezel and Keypad

The CS300 provides comprehensive HELP SCREENS with easy to follow step-by-step instructions on set-up as well as alarm and advisory conditions.

| Abbreviated Operator’s Guide | CS300| 1 |

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Quick ReferenCE – InitiAL Set-Up

1.Establish power and verify the MAINS ON/OFF and the IABP ON /OFF switches are on.

2.Open the Helium Tank.

3.Establish ECG and Pressure.

4.If using a Sensor IAB, ensure that the IAB sensor cable (orange) has been connected.* Otherwise, zero the transducer**:

νOpen the transducer to air

νPress the ZERO PRESSURE key for 2 seconds

νClose the transducer

5.Confirm that the operation mode is AUTO.

6.Attach the IAB catheter and the appropriate extender to the safety disk.

7.To initiate pumping, press the START key. In response the IABP will Autofill and then begin pumping. If desired, IAB DEFLATION timing can be fine-tuned using the IAB DEFLATION controls.

8.Verify the setting of the AUG. ALARM:

νVerify that the AUG. ALARM setting is approximately 10 mmHg less than the patient’s diastolic augmented pressure.

νIf needed, adjust by pressing the AUG ALARM key and using the NAVIGATION ARROW keys to change the value displayed on the screen.

9.Initial setup is now complete.

* For Sensor IAB Calibration:

On initial insertion, pressing the START key automatically purges and fills the IAB and calibrates the Sensor IAB if connected.

While assisting, press and hold the Zero Pressure key for two (2) seconds to perform an operator-initiated calibration of the Sensor IAB. The displayed blood pressure parameters from the IAB Sensor are only valid if the IAB Sensor is properly calibrated.

To prevent calibration of the IAB Sensor at inappropriate times, the Zero Pressure key is disabled when:

νThe IABP is in STANDBY.

νThe IAB Sensor is disconnected.

νThe Pressure Source is set to External.

νThe IAB Fill Mode is set to Manual Fill.

**For conventional IAB/Transducer:

– Zero the transducer as noted above

To prevent zeroing the transducer at inappropriate times, this key is disabled when:

νPulsatility is detected on the AP waveform.

νThe transducer is disconnected.

νThe Pressure Source is set to External.

Note: A connected and functional Sensor IAB takes priority over an arterial pressure transducer, as the Direct pressure source. The Sensor IAB must be disconnected to activate the arterial pressure transducer input. The pump automatically searches for a viable pressure source when multiple sources are available.

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IAB Sensor Low Level Pressure Output – to Bedside Monitor

This output connector is used to provide an electrical signal from the IAB Sensor module to the physiologic pressure transducer input on the patient’s bedside monitor when a Sensor IAB is connected and calibrated. Its low level output emulates that of a typical Arterial Pressure Transducer, allowing direct connection to the patient inputs of the bedside monitor when a Sensor IAB is connected and calibrated.

IAB Sensor Output – Vent

This button facilitates the zeroing process required for proper calibration of the physiologic pressure channel of an attached bedside monitor. When pressed, the IAB Sensor Output signal will simulate that of an atmospheric vented transducer. Venting will be simulated for 15 seconds to give users adequate time to zero the pressure channel on the bedside monitor.

The pressure signal will then be restored automatically to permit monitoring through the bedside and centralized monitoring systems.

OPERATING MODES

AUTO Operation Mode

All aspects of pump Operation are automated

νMost appropriate trigger source is automatically selected.

νInflation and deflation timing is automatically set.

νLead I, II, III, or External ECG source is automatically selected.

νSystem searches for the next best trigger source in the event of a loss of trigger source.

νTiming adjusts automatically if trigger source changes, heart rate changes, rhythm changes.

νWith sustained unpredictable rhythms, R-wave deflation is automatically selected. The message “Auto R-Wave Deflate” will be displayed. The deflation indicator will automatically be repositioned to the far right, “R-Trac” will be displayed in the IAB deflation indicator. The system will return to predictive timing once the rhythm becomes predictable.

SEMI AUTO Operation Mode

νOperator selects the most appropriate trigger source.

νOperator establishes initial timing and thereafter, software algorithms automatically track changes in patient heart rate or rhythm and adjusts timing accordingly.

νChanging the trigger source will cause the pump to go to Standby. Pumping will resume when the START key is pressed.

νLead I, II, III, AVR, AVL, AVF, V or External ECG source can be selected.

| Abbreviated Operator’s Guide | CS300| 3 |

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νWith sustained unpredictable rhythms and a valid ECG Trigger, R-wave deflation is automatically selected. The message “Auto R-Wave Deflate” will be displayed.

The deflation indicator will automatically be repositioned to the far right, “R-Trac” will be displayed in the IAB deflation indicator. The system will return to predictive timing once the rhythm becomes predictable.

νLoss of trigger causes an alarm and pumping will stop.

Manual Operation Mode

νTrigger source and timing of IAB inflation and deflation is determined by the operator.

νChanging the trigger source will cause the pump to go to Standby. Pumping will resume when the START key is pressed.

νLeads I, II, III, AVR, AVL, AVF, V or External ECG source can be selected.

νTiming must be readjusted by the operator if heart rate or rhythm changes.

νLoss of trigger causes an alarm and pumping will stop.

νManual timing is typically used for pediatric IABP patients.

WARNING: The CS300 must be in Semi Auto Operational mode whenever no aortic pulse is present, and IAB assist is desired. For example, whenever circulatory bypass or a laminar flow, left ventricular assist device is in use.

Trigger Source

νTrigger is the signal the CS300 uses to identify the beginning of the cardiac cycle.

νThe Trigger Source keys are only active in the SEMI AUTO and Manual Operation Modes.

νRegardless of the Operation Mode, the active trigger source is indicated by a flashing diamond in the upper right corner of the screen.

ECG

νThe R wave of the ECG is the trigger event.

νPacer spikes are rejected.

νESIS (electrosurgical interference suppression) is automatic in this mode.

νWhen using SEMI AUTO or Manual Operation modes, the ECG gain can be adjusted from 0.15 to 3.00, relative to a normal gain of 1.0. The amount of gain will be displayed next to ECG GAIN on the monitor screen. Go to Pump Options – ECG Gain to adjust.

Pressure

νThe systolic upstroke of the arterial waveform is the trigger event.

νThe CS300 will automatically adapt the pressure trigger threshold to the systolic pulse height of the arterial pressure waveform.

νThe pressure trigger threshold is displayed just below the trigger source on the monitor screen and the arterial waveform is marked with a horizontal tick to indicate the trigger point.

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νWhen using the SEMI AUTO or Manual Operation modes, a fixed pressure threshold can be manually set. Go to Pump Options - Pressure Threshold to adjust.

When using PRESSURE, the balloon must be fully deflated before the upstroke of systole.

Caution: If an irregular rhythm develops while using pressure trigger, the CS300 will automatically adjust deflation timing early to avoid interfering with systolic ejection. Do not attempt to adjust the deflation control. Pressure triggering is NOT recommended for use with sustained irregular rhythms.

Pacer V/A-V

νThis trigger mode is only available in the SEMI AUTO and Manual Operation modes.

νThe ventricular spike of a ventricular or an atrial-ventricular pacemaker is the trigger event.

νPatient must be 100% paced.

νIt is typically used when ECG triggering is unsuccessful and a ventricular or atrial-ventricular sequential pacemaker is in use.

Pacer V: Assists 100% ventricular paced rhythms up to a rate of 185 beats per minute.

Pacer A-V: Assists 100% atrial-ventricular paced rhythms provided the A-V interval is between 80-224 msec. and the pacing rate is less than 125 beats per minute.

Pacer A

νThis trigger mode is only available in the SEMI AUTO and Manual Operation modes.

νThe R-wave of the ECG is the trigger event.

νAtrial pacer spikes are enhanced and rejected.

νAtrial pacemaker pulse rejection time is expanded in this mode.

νThis trigger mode is recommended only if atrial pacer tails interfere with R-wave detection when using the ECG trigger.

νFixed or demand atrial pacing can be used in this trigger.

Caution: Never use Pacer A trigger in the presence of a ventricular paced rhythm.

Internal

νThis trigger mode is only available in the SEMI AUTO and Manual Operation modes.

νInternal trigger is used when there is no mechanical cardiac cycle, i.e. cardiopulmonary bypass or asystole.

νIn normal Operation, the rate is fixed at 80 BPM.

νThe internal trigger rate can also be adjusted from 40 to 120 BPM, in increments of 5 BPM. Go to Pump Options – Internal Rate to adjust.

Note: If an R-wave is detected when using this mode, the System automatically deflates the IAB and the message ECG Detected will be displayed on the monitor screen.

Warning: Never leave the system set in the Internal Trigger Mode if the patient is generating a cardiac output.

| Abbreviated Operator’s Guide | CS300| 5 |

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TIMING

Timing refers to the positioning of inflation and deflation points on the arterial waveform.

In the STANDBY mode an inflation marker appears as a highlighted interval on the Arterial Pressure Waveform. To supplement the marker, a horizontal bar is drawn beneath the Arterial Pressure Waveform.

To Set Initial Inflate Timing [not applicable in AUTO Operation mode.]

νUse the IAB Inflation arrows until the highlighted segment of the arterial pressure trace begins at the dicrotic notch.

To Set Initial Deflate Timing [optional with ECG Trigger in the AUTO Operation mode.]

νUse the IAB Deflation arrows to adjust the end of the highlighted segment prior to ventricular ejection.

Highlighted Inflation Marker

Dicrotic Notch

Inflation Marker

After initiating assist, the IAB INFLATION [only operational in the Semi Auto and Manual Operation modes] and IAB DEFLATION controls can be adjusted to maximize augmentation and hemodynamic unloading.

Timing at a frequency of 1:2 is illustrated below:

CLINICAL TROUBLESHOOTING – CLINICAL CONSIDERATIONS DURING OPERATION

ECG:

There are several methods to correct conditions that alter or hamper the acquisition of a reliable ECG. Reposition or replace ECG electrodes and check that the patient

cable is properly connected. In SEMI AUTO Operation mode, choose an alternate lead selection or change ECG Gain setting.

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Pressure:

Sensor IAB

The IAB Sensor Connector must be securely inserted into the IAB Sensor Module. Always take care to avoid contaminating the tip of the Sensor Connector. Confirm that the Sensor Connector is firmly seated in the IAB Sensor Module. If the Sensor Connector is reconnected to the Sensor Module, the pump will automatically calibrate the sensor within one minute or a calibration may be manually invoked

by pressing the Zero Pressure key while the pump is assisting.

Conventional IAB/Transducer

Flush arterial line at regular intervals per standard hospital procedure. Adequate flushing to maintain pressure line patency and alignment of stopcock in the proper position will prevent the majority of possible pressure trace problems.

Atrial Fibrillation:

In AUTO Operation mode, there are no special pump considerations for handling atrial fibrillation. In SEMI AUTO Operation mode, use ECG Trigger. This will track random rhythm most consistently, by automatically holding the IAB inflated until

the detection of the next R-Wave. Pressure triggering is NOT recommended in atrial fibrillation.

Triggering on Ectopics:

The CS300 automatically deflates on and assists the ectopic beat, if the ectopic R-wave is sensed. In SEMI AUTO Operation mode, if the ectopic beat is of small amplitude, reliable triggering can be maximized if an ECG Lead is selected which minimizes the amplitude difference between the normal QRS complex and that of the ectopic beat. No special adjustments are necessary.

Cardiac Arrest – Ventricular Fibrillation:

When defibrillating the patient, the CS300 has protection and is completely isolated from the patient and the defibrillator’s electrodes. However, the operator should stand clear of the pump during defibrillation. This is particularly important when the CS300 is operated while disconnected from an earth grounding point, such as the A.C. power receptacle.

Ventricular Standstill or Prolonged Cardiac Arrest:

If possible, use ECG or Arterial Pressure trigger during CPR. This facilitates synchronization of the assist to the rate and rhythm of chest compressions. In AUTO Operation mode, the ECG (R-wave) or Arterial Pressure signal will automatically be selected as the Trigger Source. Choice is dependent upon relative signal quality. If neither the ECG nor the Arterial Pressure signals produce adequate trigger reliability to allow for AUTO Operation, the IABP may be triggered by its own internal clock. Select the SEMI AUTO Operation mode and set the Trigger Source to Internal. The default internal rate is 80 bpm but can be varied between 40 and 120 bpm by accessing the

Pump Options menu and setting the Internal Rate.

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