CS100 and CS100i Abbreviated Operators Guide Rev F

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).

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 1 |

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. 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

n

n

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 n n

n

n n

n

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 n

n

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.

n

Lead 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 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.

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 3 |

Trigger Source n n

n

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 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 n

n

n

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 n

n

n n

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 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

n

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 n

n

n n

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.

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 5 |

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

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:

| 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.

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 7 |

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 deflating) 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.

| 8 | CS100 ®/CS100i ® | Abbreviated Operator’s Guide |

Use in Electro-surgical Environment The CS100 IABP has built in electro-surgical interference suppression that minimizes Electro-Surgical Unit (ESU) noise from disturbing system performance. While the system will suppress ESU noise, it cannot eliminate it all together. Sparking to tissue occurs when an ESU is operated. This generates noise that extends into the ECG frequency range. Since the system must pass these frequencies, some ESU noise may interfere with the ECG signal, particularly with high ESU power settings. Limiting the power of this noise energy is desirable. The magnitude of interference is directly related to the power setting of the ESU, which should be as low as possible for the intended effect. Successful ECG triggering in the presence of ESU noise depends, to a large extent, on proper patient preparation and ESU use. Following the guidelines listed will minimize the amount of energy coupled from the ESU to the ECG input of the CS100, generally resulting in stable ECG triggering. When the CS100 is in AUTO Operation mode, it will automatically select Pressure Trigger when ESU interference is detected and return to ECG a short interval after interference ceases. If the clinician prefers to stay in Pressure Trigger during the operating room procedure, this can be accomplished by selecting SEMI AUTO Operation mode. Then select Pressure Trigger Source. Return to AUTO Operation mode when appropriate. When the CS100 is used in an electrosurgical environment, the following techniques are recommended to minimize interference from electrosurgical devices: n

n

n n

n

Always use supplied MAQUET Operating Room ECG patient cable and lead wire option. See “ECG Patient Cable Options” on page 10-5 of the CS100 Operator’s Manual for more information. These cables are shielded and incorporate ESU suppression components. Keep the ECG cables at right angles to the electrosurgical cables to the greatest extent possible. Locate the ECG electrodes as far away from the surgical site as possible. Locate the ECG electrodes approximately equidistant from the surgical site to minimize any difference in potential between electrodes. Place all ECG electrodes on the same plane (either anterior or posterior) to minimize any difference in potential between electrodes.

n

Place the electrosurgical return plate directly under the surgical site.

n

Use the minimum required electrosurgical setting.

WARNING: External bedside monitors used with the CS100 in the operating room, must be equipped with electro-surgical interference suppression.

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 9 |

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 n

n

n

n

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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 n

n n

n

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 section, 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 n

n

n n

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 n

n

n

n

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: n

Select ECG trigger source, using the TRIGGER SOURCE arrow keys, when demand pacing a patient.

n

Reduce the Pacer rate.

n

Adjust the A-V time interval to between 80 and 224 msec.

For Trigger Interference: n n

n

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.

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 11 |

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. n

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

 he IAB catheter or extender tubing is T disconnected.

Check IAB Catheter

 he IAB membrane is not completely T 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

 he IABP cannot fill the IAB catheter T system automatically.

Autofill Required [SA / M]

The IAB fill mode has been changed from Manual to AUTO without an autofill.

OPERATOR Intervention n

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.

n

Verify all connections are leak free.

n

For “Autofill Failure-No Helium” open or replace Helium tank if necessary.

n

n

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 displayed 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.

| 12 | CS100 ®/CS100i ® | Abbreviated Operator’s Guide |

ALERTS n

n

n

Alert messages are displayed in the ADVISORIES section of the screen. IAB pumping is not suspended with Alert conditions. A double beep tone signals the operator that corrective action is required. Alert conditions that do not require immediate intervention will result in a double beep that repeats for 30 seconds (no tone will sound for Heart Rate Low). The Alert message remains displayed until the alert condition is corrected. ALERT MESSAGE [AUTO Operation mode]

CAUSE

Poor Signal Quality

Both ECG and Arterial Pressure signal quality is poor while in ECG trigger.

No Pressure Source Available

Neither a direct nor external blood pressure source was detected.

Unable to Update Timing

Waveform quality is poor.

ALERT MESSAGE [SEMI AUTO OR MANUAL Operation mode]

CAUSE

ECG Detected

 CG activity is detected persistently for 4-6 E seconds while in the Internal Trigger mode.

Irregular Pressure Trigger SEMI AUTO only

While Pressure is the Trigger source, erratic trigger is due to: 1. Arrhythmic patient rhythm 2. Late deflation; inhibiting pressure pulse detection.

Manual Timing selected – see Help - MANUAL only

The operator selected the Manual Operation mode.

Verify Proper Timing – SEMI AUTO only

The operator selected the Semi Auto Operation mode.

ALERT MESSAGE [ALL Operation modes]

CAUSE

Augmentation Below Limit Set

Diastolic Augmentation has dropped below the user selected limit.

Low Battery

 attery Reserve falls below the 30 minutes of B operating time.

Maintenance Required Code # ___

System maintenance may be required.

Low Helium

 elium supply is below a preset reserve as H determined by tank pressure.

Prolonged Time in Standby

Pump has been in STANDBY for at least 10 minutes.

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 13 |

STATUS/PROMPTS n n

n

Status/Prompt messages are displayed in the ADVISORIES section of the display. Status/Prompt messages do not sound any tones (with the exception of Unplug Disk Outlet & Plug Disk Outlet) and are advisory in nature. Status/Prompts apply to all Operation modes unless otherwise indicated: A = Auto / SA = Semi Auto / M = Manual Operation mode. STATUS/PROMPT MESSAGE

CAUSE

IAB not filled [SA / M]

System is in Manual Fill and user pressed the START key when no fill had been performed.

Verify Proper Timing [SA / M]

Operator has changed the trigger source.

Manual Fill IAB [SA / M]

 otifies the operator when to manually fill the N IAB catheter with shuttle gas. Displayed in the MANUAL FILL mode when the FILL key is activated, venting the safety disk.

Leak Testing Safety Disk

Indicates safety disk leak test is in progress.

Autofilling

Indicates that the system is in the process of Automatically purging and refilling the IAB with Helium.

Automatic Operation mode is disabled. [SA / M]

System is set to Manual Fill mode and the [SA / M] operator tries to select AUTO Operation mode.

Gas Loss and Catheter Alarms Disabled [SA / M]

All leak and catheter alarms are disabled when the manual fill mode is selected.

Slow Gas Loss Alarm is Off

 low gas loss alarm has been disabled by S the user. NOTE: Rapid gas loss function is still active.

Function unavailable in AUTO Operation mode [A]

Displayed when the operator presses an unavailable key while in the AUTO Operation mode.

Battery in Use

Indicates system is operating from an internal battery.

System Test OK

All systems passed power-up diagnostics.

System Trainer

Displayed when the System Trainer is being used as ECG and Pressure source.

Auto R-Wave Deflate [A /SA] R-Trac in IAB deflation indicator

R-Trac is on. The patient’s rhythm is too random to predict the occurrence of the next beat. In response, the system has automatically selected the R-Wave Deflation Mode.

R-Wave Deflate [A /SA]

 perator has enabled R-Wave deflation by O moving the deflate key to the extreme right position.

| 14 | CS100 ®/CS100i ® | Abbreviated Operator’s Guide |

MENU GUIDE The CS100 uses menus to provide rapid access to infrequently used functions. The menu guide, below, is also located on the top of the CS100 console. MENU NAVIGATION The first step in the menu navigation is to open the desired menu by pressing the associated key. The highlighted bar is always used as a pointer [cursor] to select menu entries. The arrow keys in the menu navigation circle control the movement of the highlighted bar. To select an alternative item, use the UP and DOWN arrow keys.

Ref. Line

ECG/AP Sources ECG Lead Source* Pressure Source

Pump Options Aug. Alarm

*Not available in "AUTO" operation mode.

ECG Gain* Pressure Threshold* Internal Rate* Slow Gas Alarm IAB Fill Mode* Arterial Pressure Delay* R-Trac

User Preferences Display Preferences Sweep Speed Balloon Waveform Brightness ECG Inflation Markers Flash Alarms

Audio Preferences Alarm Volume Standby Advisory Tone Beep Volume

Printer Preferences

Menu Guide 24hr. Emergency Helpline 1.800.777.4222

First Waveform Second Waveform Strip Length Timed Print Print on Alarm Print Trigger & Alarm Log

Set Time and Date

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 15 |

PRINTER OPERATION The dual trace recorder provides a hard copy record of patient waveforms. Printouts follow the format defined by the setting in the Printer Preferences submenu, located in the User Preferences menu. Dual or single trace formats may be selected. Waveform choices are: ECG, Arterial Pressure and Balloon Pressure Waveforms. At the completion of the recording, an annotated trailer is appended to the print. The annotation describes patient and system status. The format of the annotation depends upon the IAB Assist Frequency selection. When 1:2 or 1:3 is selected as the IAB frequency, the recorder will print both assisted and unassisted systolic and diastolic pressure information. To initiate a printout, press the PRINT STRIP key. To start a continuous printout, hold the PRINT STRIP key for two (2) seconds. The associated LED will blink as printing continues. To stop the continuous printout, press the PRINT STRIP key again.

DOPPLER The Doppler used with the CS100 uses ultrasound techniques to detect vascular blood flow. To use the Doppler: 1. Open the top storage bin. The Doppler is located inside the door panel. 2. Remove the Doppler from the storage bin. 3. Press the button on the tether to reel or retract the Doppler. 4. Place a liberal amount of coupling gel on the transducer surface or on the patient’s skin. 5. Turn the unit on and position the probe over the artery to be examined. 6. Hold the probe at a 45˚ angle to the surface of the skin. 7. Listen for pulsatile blood flow sounds, adjust the volume control as needed. If battery replacement is necessary, remove the cover of the battery compartment, and lift out the old battery. Install a new 6lR61, 6LF22, or equivalent 9V alkaline battery.

| 16 | CS100 ®/CS100i ® | Abbreviated Operator’s Guide |

Safety Disk Leak Test This optional test measures the pneumatic leak rate(s) of the Safety Disk. The test requires multiple interactions with the operator. Specifically during the course of the test, the operator is requested to plug and unplug the outlet of the safety disk. The CS100 prompts the user at the appropriate times for this action. WARNING: Safety Disk Leak Test MUST NOT be performed when the system IAB is connected to the patient. 1. Press and hold the IAB Fill key while switching IABP ON/OFF to ON. This switch is located on the top right of console’s front panel. Release the IAB Fill key when the message LEAK TESTING SAFETY DISK appears in the advisory section of the screen. NOTE: If the IAB Catheter Extender Input is not vented to air at the start of the Safety Disk Leak Test, a double beep alarm tone will sound and the message UNPLUG DISK OUTLET will be displayed. After approximately 10 seconds, a tone sounds and the message PLUG DISK OUTLET is displayed in the advisory section of the screen. 2. Plug the IAB Catheter Extender Input on the safety disk with a dead end Luer plug. 3. A double beep will sound at the end of the safety disk test. If the system passes the test, the message SYSTEM TEST OK is displayed in the advisory section of the screen. Remove dead end Luer plug. NOTE: If the message on the display is SAFETY DISK TEST FAILS, inspect all pneumatic connections and Luer locks. Switch the IABP On/Off to the OFF position and repeat from Step 1. If in doubt about the integrity of the safety disk, replace it. See Safety Disk/ Condensate Removal Module on page 7-6.

| Abbreviated Operator’s Guide | CS100 ®/CS100i ® | 17 |

TRANSPORT CONSIDERATIONS Portable Operation MAQUET recommends the following during portable Operation: 1. Battery fully charged 2. Back up battery available 3. Altitude changes are compensated for automatically in the Auto Fill mode or manually in the Manual Fill mode. 4. The system is secure and stable when used on an ambulance, helicopter or fixed wing aircraft. The CS100 is available in two versions with identical clinical functionality. A console version with a hospital cart or the CS100 Universal Transport System (UTS). Both are designed for air and vehicular transport. The UTS version mechanically attaches to a docking station for high strength mounting. CAUTION: The user should continually rely on visual alarm messages during high noise transport situations. The “Flash Alarms” option should be turned ON to improve the visibility of alarm messages. This option can be set in the User Preferences Menu (located in the Display Preferences submenu.) NOTE: Prior to transport, ensure that the Helium cylinder yoke handle is tight and the Helium pressure gauge is a least 25% full. Approximately every 30 minutes during transport verify that the yoke handle is tight and that a noticeable pressure drop has not occurred. NOTE: Prior to using the system in any other position except vertical, consult with Technical Service. NOTE: For information on outfitting an aircraft for IABP transport contact your local MAQUET sales representative. See “Accessories” on page 10-9 of the CS100 Operator’s Manual for information on the Transport Docking Station.

| 18 | CS100 ®/CS100i ® | Abbreviated Operator’s Guide |

Battery Operation During portable Operation, the CS100 is powered by a rechargeable battery. Prior to portable Operation the battery should be fully charged. A fully charged battery is indicated by a continuously illuminated battery charging LED. This LED is located on the front panel. The BATTERY IN USE status message and the Battery Indicator are displayed when the CS100 is operating from the internal rechargeable battery. When the battery has approximately 30 minutes of operating time remaining the following occurs: n

An audible double beep alarm is activated for 30 seconds.

n

The Low Battery or [EXT] alert message is displayed on the screen continuously.

n

The Battery Indicator is displayed as empty and it starts flashing.

n

The condensate removal module will not operate.

Portable/Transport Operation Battery Charging To charge the internal battery: 1. Leave the system power cord plugged in and set the MAINS On/Off to ON. 2. Check that the Battery Charging LED is illuminated (continuously or flashing depending on state). 3. Allow a minimum of 18 hours to fully charge a low battery. 4. A fully charged new internal battery will provide at least 135 minutes of portable Operation. NOTE: A reduction in run time will occur over a battery’s life due to age, storage temperature and discharge depth. Batteries which are continually subjected to complete discharge cycles without the recommended immediate recharging, can incur permanent damage. See “User Maintenance” on page 7-12 of the CS100 Operator’s Manual for additional information.