Maquet CS100i Manual

DATASCOPE IS NOW MAQUET CARDIOVASCULAR
THE CS100®/CS100i®
ABBREVIATED OPERATOR’S GUIDE

CS100 BEZEL AND KEYPAD
This guide is a reference for personnel trained in using the MAQUET CS100. Complete
instructions for operation are provided in the MAQUET Operating Instructions: CS100 Manual
(PN: 0070-00-0529-01).
Do not use this guide until after thoroughly reading the Operating Instructions. Caution: Federal law
restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

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| Abbreviated Operator’s Guide | CS100®/CS100i®|
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 cylinder and verify the helium pressure.
3. Establish ECG and Pressure connection from the patient.
4. Zero the transducer.
a. Open the transducer to air.
b. Press the ZERO PRESSURE key for 2 seconds.
c. 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. Fill the IAB catheter and initiate pumping.
a. Press the START key and observe the AUTO FILLING message.
b. Once the AUTO FILLING message clears, pumping begins.
c. If desired, IAB deflation timing can be fine-tuned using the IAB deflation
controls.
8. Verify AUG. ALARM.
a. Verify that the AUG. ALARM setting is approximately 10 mmHg less than the
patient’s augmented diastolic pressure.
b. Adjust, if needed by pressing AUG. ALARM key and using the up and down arrow
keys, in the navigation circle, to change the value displayed on the screen.
Initial Set-up is now complete.
The CS100 provides comprehensive HELP SCREENS with easy to follow
step-by-step instructions on set-up as well as all alarm and alert conditions.

| 2| CS100®/CS100i®| Abbreviated Operator’s Guide |
OPERATING MODES
AUTO Operation Mode
All aspects of pump Operation are automated.
Most appropriate trigger source is automatically selected.
Inflation and deflation timing is automatically set.
Lead I, II, III, or External ECG source is automatically selected.
System searches for the next best trigger source in the event of a loss of
trigger source.
Timing adjusts automatically if trigger source changes, heart rate changes, rhythm
changes.
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
Operator selects the most appropriate trigger source.
Operator establishes initial timing and thereafter, software algorithms
automatically track changes in patient heart rate or rhythm and adjusts
timing accordingly.
Changing the trigger source will cause the pump to go to Standby. Pumping will
resume when the START key is pressed.
Lead I, II, III, AVR, AVL, AVF, V or External ECG source can be selected.
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.
Loss of trigger causes an alarm and pumping will stop.
Manual Operation Mode
Trigger source and timing of IAB inflation and deflation is determined by
the operator.
Changing the trigger source will cause the pump to go to Standby. Pumping will
resume when the START key is pressed.
Lead I, II, III, AVR, AVL, AVF, V or External ECG source can be selected.
Timing must be readjusted by the operator if heart rate or rhythm changes.
Loss of trigger causes an alarm and pumping will stop.
Manual timing is typically used for pediatric IABP patients.
WARNING: The CS100 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.

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| Abbreviated Operator’s Guide | CS100®/CS100i®|
TRIGGER SOURCE
Trigger is the signal the CS100 uses to identify the beginning of the cardiac cycle.
The Trigger Source keys are only active in the SEMI AUTO and Manual
Operation Modes.
Regardless of the Operation Mode, the active trigger source is indicated by a flashing
diamond in the upper right corner of the screen.
ECG
The R wave of the ECG is the trigger event.
Pacer spikes are rejected.
ESIS (electrosurgical interference suppression) is automatic in this mode.
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
The systolic upstroke of the arterial waveform is the trigger event.
The CS100 will automatically adapt the pressure trigger threshold to the
systolic pulse height of the arterial pressure waveform.
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.
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 CS100 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
This trigger mode is only available in the SEMI AUTO and Manual Operation
modes.
The ventricular spike of a ventricular or an atrial-ventricular pacemaker is the trigger
event.
Patient must be 100% paced.
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.

| 4| CS100®/CS100i®| Abbreviated Operator’s Guide |
Pacer A
This trigger mode is only available in the SEMI AUTO and Manual Operation
modes.
The R-wave of the ECG is the trigger event.
Atrial pacer spikes are enhanced and rejected.
Atrial pacemaker pulse rejection time is expanded in this mode.
This trigger mode is recommended only if atrial pacer tails interfere with R-wave
detection when using the ECG trigger.
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
This trigger mode is only available in the SEMI AUTO and Manual Operation
modes.
Internal trigger is used when there is no mechanical cardiac cycle, i.e.
cardio-pulmonary bypass or aystole.
In normal Operation, the rate is fixed at 80 BPM.
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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| Abbreviated Operator’s Guide | CS100®/CS100i®|
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.]
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.]
Use the IAB Deflation arrows to adjust the end of the highlighted segment prior to
ventricular ejection.
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:
INFLATION MARKER
HIGHLIGHTED INFLATION MARKER
DICROTIC NOTCH

| 6| CS100®/CS100i®| Abbreviated Operator’s Guide |
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.
Pressure:
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 CS100 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 CS100 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
CS100 is operated while disconnected from an earth grounding point, such as the A.C.
power receptacle.

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| Abbreviated Operator’s Guide | CS100®/CS100i®|
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.
Prolonged Time in Standby and Thrombus on the IAB membrane:
If the CS100 is inadvertently placed in STANDBY, the time in STANDBY, will appear on
the left side of the monitor screen. After 10 minutes an alert message will appear. The
audible alert is user selectable. Verify whether it is appropriate to resume assist. If so,
press the START key to resume assist.
WARNING: The patient balloon should not remain inactive (i.e., not inflating and deflat-
ing) for more than 30 minutes; due to the potential for thrombus formation.
CHANGE IN PRESSURE MONITORING SITE:
If patient’s pressure monitoring site is changed while assisting in SEMI AUTO or
Manual Operation mode, the INFLATION INTERVAL key can be quickly pressed and
released to recalculate arterial pressure transmission delay (APD). This will assure
accurate digital pressure display values and arterial pressure trace inflation interval
markers.

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| Abbreviated Operator’s Guide | CS100®/CS100i®|
SYSTEM ALARMS MESSAGES AND ADVISORIES
Help screens are provided to guide the user through set-up procedures and for
consultation regarding alarm message descriptions and alarm configurations. Help
screens are context sensitive and available based on the information displayed on the
screen.
Detailed information on all Alarms, Alerts, and Status/Prompts is provided in the CS100
Operating Instructions.
ALARMS
ALARM messages are displayed in the ALARM MESSAGES section of the monitor
display. IABP assist is suspended and a steady tone will sound.
TRIGGER ALARMS
These alarms indicate the selected trigger source is either not available or not reliable.
Pumping is suspended and a steady tone sounds. Pumping will automatically resume
once the trigger has been reestablished.
MESSAGE [AUTO OPERATION MODE] PROBABLE CAUSE
No Trigger Valid ECG and Arterial Pressure
trigger do not exist or are lost.
Poor Signal Persists Both ECG and Arterial Pressure signal quality
have been poor for a sustained period.
OPERATOR INTERVENTION
For No Trigger
Reattach or reposition the electrode and check the integrity of all cable/lead
connections.
Switch Operation to SEMI AUTO and increase the ECG Gain setting in the PUMP
OPTIONS menu.
Use IAB Inflation and IAB Deflation controls to adjust timing and resume
pumping by pressing the START key.
Verify that the transducer was not left vented; check all transducer cable
connections.
Attempt to restore A.P. pulse height by flushing the circuit.
For Poor Signal Persists
Attempt to restore A.P. pulse height by flushing the circuit, verify transducer was not
left vented; check integrity of all cable connections.
Attempt to improve ECG signal by ensuring electrode contact and optimal placement.
If signal problem persists, switch Operation mode to SEMI AUTO. Verify trigger
source.
Use IAB Inflation and IAB Deflation controls to adjust timing and resume
pumping by pressing the START key.

| 10 | CS100®/CS100i®| Abbreviated Operator’s Guide |
MESSAGE [SEMI AUTO OR
MANUAL OPERATION MODE]
PROBABLE CAUSE
No Trigger Valid trigger, as defined in Specification sec-
tion, does not exist or is lost in ECG or Pacer
Trigger mode.
No Pressure Trigger Valid trigger is unavailable or is lost while in
pressure trigger.
Check Pacer Timing The patient is not 100% paced or V/A-V pacer
trigger interval varies >25% or an A-V pacer
rate is >125 bpm.
Trigger Interference Electro-Surgical Noise [ESU] detected while the
Pacer Trigger Source is selected.
OPERATOR INTERVENTION
For No Trigger
Reattach or reposition the electrode and check the integrity of all cable/lead
connections.
Try ECG lead selections via the ECG/AP Sources menu, or select EXT. ECG,
if appropriate.
Adjust the ECG Gain by accessing the PUMP OPTIONS menu.
Select a different trigger source using the TRIGGER SOURCE arrow keys.
Resume pumping by pressing the START key.
For No Pressure Trigger
Verify that the desired Pressure Source, DIRECT/EXTERNAL, is selected.
Use the ECG/AP Sources menu to select the Pressure Source.
Verify that the transducer was not left vented; check all transducer cable
connections.
If pressure trigger is required and manual threshold is selected, reduce the
pressure trigger threshold by using the PRESSURE THRESHOLD sub menu from the
PUMP OPTIONS menu.
If appropriate, select a different trigger source using the TRIGGER SOURCE arrow
keys. Resume pumping by pressing the START key.
For Check Pacer timing:
Select ECG trigger source, using the TRIGGER SOURCE arrow keys, when demand
pacing a patient.
Reduce the Pacer rate.
Adjust the A-V time interval to between 80 and 224 msec.
For Trigger Interference:
Pumping automatically resumes when interference clears.
If the condition persists, then select pressure trigger using the TRIGGER SOURCE
arrow keys.
Verify timing and press the START key to resume pumping.

11 |
| Abbreviated Operator’s Guide | CS100®/CS100i®|
CATHETER ALARMS
The CS100 continually monitors specific parameters within the closed patient
pneumatic system. If a change is detected or a specific parameter is violated,
IABP Assist is suspended and a continuous tone will sound.
Status/Prompts apply to all Operation modes unless otherwise indicated:
A= Auto / SA = Semi Auto / M= Manual Operation mode.
MESSAGE PROBABLE CAUSE
Leak in IAB Circuit There is a small leak or gas gain in the IAB
circuit, a loose connection, or a high rate of
helium diffusion.
Rapid Gas Loss A large leak has been detected in the IAB
pneumatic circuit.
IAB Disconnected The IAB catheter or extender tubing is
disconnected.
Check IAB Catheter The IAB membrane is not completely
unfolded, or the IAB remains in the sheath
immediately after insertion or there is a kink
in the IAB catheter or tubing.
Blood Detected Blood is detected in the IAB catheter.
Autofill Failure -No Helium The Helium tank is closed or empty.
Autofill Failure The IABP cannot fill the IAB catheter
system automatically.
Autofill Required
[SA / M]
The IAB fill mode has been changed from
Manual to AUTO without an autofill.
OPERATOR INTERVENTION
Inspect the IAB and catheter extender tubing for any evidence of a leak,
including the safety disk/condensate removal assembly connections, IAB
catheter connections, autofill tubing and drain port. Check for blood in the
tubing, if noticed stop pumping and notify a Physician.
Verify all connections are leak free.
For “Autofill Failure-No Helium” open or replace Helium tank if necessary.
Inspect the IAB catheter and catheter extender for evidence of a kink or
restriction to Helium flow.
Fill the IAB, if instructed, by pressing the IAB FILL key for 2 seconds.
Resume pumping by pressing START.
WARNING: If blood is observed within the catheter or catheter extender tubing at any
time during the IAB procedure, stop pumping, notify the physician immediately, and
prepare for IAB removal.
WARNING: When the System is operated in MANUAL FILL, the IAB gas loss and catheter
alarms are disabled. The message, “Gas Loss And Catheter Alarms Disabled” will be dis-
played in the Advisory section of the display. The IAB status bar will not be active.
WARNING: Under certain heart rate and timing conditions, catheter alarms may be
suspended. Refer to the Operating Instructions for further detail.