Maquet C300 User manual

THE CS300

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™

ABBREVIATED OPERATOR’S GUIDE

DATASCOPE IS NOW MAQUET CARDIOVASCULAR

CS300 BEZEL AND KEYPAD

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

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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**:

n Open the transducer to air

n Press the ZERO PRESSURE key for 2 seconds

n Close 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:

n Verify that the AUG. ALARM setting is approximately 10 mmHg less than

the patient’s diastolic augmented pressure.

n If 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.

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* 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:

n The IABP is in STANDBY.

n The IAB Sensor is disconnected.

n The Pressure Source is set to External.

n The 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:

n Pulsatility is detected on the AP waveform.

n The transducer is disconnected.

n The 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

n Most appropriate trigger source is automatically selected.

n Inflation and deflation timing is automatically set.

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

n System searches for the next best trigger source in the event of a loss of

trigger source.

n Timing adjusts automatically if trigger source changes, heart rate changes,

rhythm changes.

n With 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

n Operator selects the most appropriate trigger source.

n Operator establishes initial timing and thereafter, software algorithms automatically

track changes in patient heart rate or rhythm and adjusts timing accordingly.

n Changing the trigger source will cause the pump to go to Standby. Pumping will

resume when the START key is pressed.

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

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n With 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.

n Loss of trigger causes an alarm and pumping will stop.

Manual Operation Mode

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

n Changing the trigger source will cause the pump to go to Standby. Pumping

will resume when the START key is pressed.

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

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

n Loss of trigger causes an alarm and pumping will stop.

n Manual 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

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

n The Trigger Source keys are only active in the SEMI AUTO and Manual Operation

Modes.

n Regardless of the Operation Mode, the active trigger source is indicated by a flashing

diamond in the upper right corner of the screen.

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ECG

n The R wave of the ECG is the trigger event.

n Pacer spikes are rejected.

n ESIS (electrosurgical interference suppression) is automatic in this mode.

n When 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

n The systolic upstroke of the arterial waveform is the trigger event.

n The CS300 will automatically adapt the pressure trigger threshold to the systolic

pulse height of the arterial pressure waveform.

n The 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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n When 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

n This trigger mode is only available in the SEMI AUTO and Manual Operation

modes.

n The ventricular spike of a ventricular or an atrial-ventricular pacemaker is the trigger

event.

n Patient must be 100% paced.

n It 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

n This trigger mode is only available in the SEMI AUTO and Manual Operation

modes.

n The R-wave of the ECG is the trigger event.

n Atrial pacer spikes are enhanced and rejected.

n Atrial pacemaker pulse rejection time is expanded in this mode.

n This trigger mode is recommended only if atrial pacer tails interfere with R-wave

detection when using the ECG trigger.

n Fixed 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

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

n Internal trigger is used when there is no mechanical cardiac cycle, i.e. cardio-

pulmonary bypass or asystole.

n In normal Operation, the rate is fixed at 80 BPM.

n The 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.

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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.]

n Use 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.]

n Use the IAB Deflation arrows to adjust the end of the highlighted segment prior to

ventricular ejection.

HIGHLIGHTED INFLATION MARKER

DICROTIC NOTCH

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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.