MAQUET

MAQUET Intra Aortic Balloon Pumps

IAB INSERTION and CARDIOSAVE IABP OPERATION Quick Reference Guide PN 0002-08-1049 R3 Rev C

Quick Reference Guide

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File Name: MAQUET - IAB INSERTION and CARDIOSAVE IABP OPERATION Quick Reference Guide PN 0002-08-1049 R3 Rev C.pdf

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Page 1

QUICK REFERENCE GUIDE IAB INSERTION / Cardiosave IABP Operation ®

| 1 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

Note: This is an abbreviated guide. For complete instructions, refer to IAB Instructions for Use and CARDIOSAVE Operating Instructions.

| 2 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

IAB SIZING

Intra-Aortic Balloon INTRA-AORTIC BALLOON Reference Sizing guide NEW SIZING GUIDE 6' 5'

< 5'0" (< 152cm)

5'0" to 5'4" (152cm - 162cm)

5'4" to 6'0" (162cm - 183cm)

5'4" & taller (≥ 162cm)

NEW

30cc

40cc

50cc

SENSATION PLUS® 7.5Fr.

SENSATION PLUS® 8Fr.

MEGA® 7.5Fr.

MEGA® 8Fr.

25cc

34cc

40cc

SENSATION® 7Fr.

LINEAR® 7.5Fr.

Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should be considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS are fiber-optic IAB catheters.

MEGA AND LINEAR IAB Catheter ®

Preparing the IAB Catheter

Firmly attach one-way valve to male luer fitting of IAB catheter.

Apply a 30cc vacuum.

Remove syringe while keeping one-way valve in place.

Remove stylet, then manually flush inner lumen with 3-5cc of flush solution.

| 3 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

MEGA & LINEAR INSERTION

| 4 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

MEGA AND LINEAR IAB Catheter Sheathless Insertion

5 6

Insert needle at 45˚ angle or less, then insert 0.025" (0.06cm) guidewire.

Make small incision at exit of guidewire.

Insert vessel dilator over guidewire, tapered end first, then remove.

Spread tissue at incision to facilitate sheathless insertion.

Remove IAB catheter from T-handle by pulling STRAIGHT out to avoid damaging it. Do not dip, wipe, or handle membrane prior to insertion.

Advance IAB catheter into artery using short strokes until correct placement is achieved, then advance sheath seal as close to insertion site as possible.

Secure IAB catheter to patient’s leg using STATLOCK® IAB Stabilization Device or sutures.

MEGA AND LINEAR IAB Catheter Sheathed Insertion

Insert needle at 45˚ angle or less, then insert 0.025" (0.06cm) guidewire.

Make small incision at exit of guidewire.

Insert introducer dilator into sheath hub and twist lock in place to secure.

1 Advance sheath over guidewire into artery using a rotary motion. 2 Withdraw introducer dilator leaving sheath in place.

Remove IAB catheter from T-handle by pulling STRAIGHT out to avoid damaging it. Do not dip, wipe, or handle membrane prior to insertion.

Advance IAB catheter through sheath using short strokes until correct placement is achieved, then advance sheath seal into hub of sheath.

Secure IAB catheter to patient’s leg using STATLOCK® IAB Stabilization Device or sutures.

| 5 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

MEGA & LINEAR INSERTION

| 6 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

MEGA AND LINEAR IAB Catheter Pressure Monitoring Set-Up

Remove guidewire and aspirate 3cc of blood from inner lumen.

Manually flush inner lumen with 3-5cc of flush solution.

Attach a standard arterial pressure monitoring apparatus.

Remove one-way valve from IAB catheter.

Connect IAB catheter’s male luer fitting to female luer fitting of catheter extender.

Connect male luer fitting to Pneumatic Module of IABP.

Connection to IABP

SENSATION PLUS AND SENSATION IAB Catheter ®

Preparing the IAB Catheter

Firmly attach one-way valve to male luer fitting of IAB catheter.

Apply a 30cc vacuum.

Remove syringe while keeping one-way valve in place.

Remove stylet, then manually flush inner lumen with 3-5cc of flush solution.

| 7 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

SENSATION PLUS & SENSATION INSERTION

| 8 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

SENSATION PLUS AND SENSATION IAB Catheter Sheathless Insertion

4 5

Insert needle at 45˚ angle or less, then insert guidewire (7.5Fr./8Fr. IAB: 0.025" (0.06cm) / 7Fr. IAB: 0.018" (0.05cm).

Make small incision at exit of guidewire.

Insert vessel dilator over guidewire, tapered end first, then remove.

Spread tissue at incision to facilitate sheathless insertion.

Note: Continue on page 10, step #13.

Remove IAB catheter from T-handle by pulling STRAIGHT out to avoid damaging it. Do not dip, wipe, or handle membrane prior to insertion.

Advance IAB catheter into artery using short strokes until correct placement is achieved, then advance sheath seal as close to insertion site as possible.

Secure IAB catheter to patient’s leg using STATLOCK® IAB Stabilization Device or sutures (SENSATION PLUS includes STATLOCK® in IAB box).

SENSATION PLUS AND SENSATION IAB Catheter Sheathed Insertion

Insert needle at 45˚ angle or less, then insert guidewire (7.5Fr./8Fr. IAB: 0.025" (0.06cm) / 7Fr. IAB: 0.035" (0.09cm).

Make small incision at exit of guidewire.

Insert introducer dilator into sheath hub and twist lock in place to secure.

1 Advance sheath over guidewire into artery using a rotary motion. 2 Withdraw introducer dilator leaving sheath in place.

7Fr. IAB only: 9a Remove 0.035" (0.09cm) guidewire and 9b Replace with 0.018" (0.05cm) guidewire.

Remove IAB catheter from T-handle by pulling STRAIGHT out to avoid damaging it. Do not dip, wipe, or handle membrane prior to insertion.

Advance IAB catheter through sheath using short strokes until correct placement is achieved, then advance sheath seal into hub of sheath.

Secure IAB catheter to patient’s leg using STATLOCK® IAB Stabilization Device or sutures (SENSATION PLUS includes STATLOCK® in IAB box).

| 9 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

SENSATION PLUS & SENSATION INSERTION

| 10 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

SENSATION PLUS AND SENSATION IAB Catheter Pressure Monitoring Set-Up

Remove guidewire and aspirate 3cc of blood from inner lumen.

Manually flush inner lumen with 3-5cc of flush solution.

Attach a standard arterial pressure monitoring apparatus.

17 15

Remove one-way valve from IAB catheter.

Connect IAB catheter’s male luer fitting to female luer fitting of catheter extender.

Connect male luer fitting of catheter extender to Pneumatic Module of IABP. Insert fiber-optic sensor connector into IABP’s sensor input receptacle until it clicks.

Connection to IABP

Note: With SENSATION PLUS, a reliable pressure signal may be obtained via the inner lumen, if needed.

CARDIOSAVE INITIAL SET-UP 3 Connect ECG cable.

4 Connect fiber-optic IAB: for MAQUET/Datascope fiber-optic IAB.

1 Press POWER button to turn IABP ON.

4 Connect pressure cable: for conventional IAB.

2 Open helium tank (if not already opened). | 11 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

5 Connect IAB.

CARDIOSAVE SET-UP

| 12 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

CARDIOSAVE SET-UP

INITIAL SET-UP USING A MAQUET/DATASCOPE FIBER-OPTIC IAB (CONTINUED) ECG

Lead: Auto - II

Rate

Source: Fiber-Optic

Pressure

bpm

0.5 mV

Trigger: ECG Arterial 130

30 Inflation

Inflated

MEAN

Deflation

Auto Balloon Pressure

Deflated

102 52

mmHg

0.0

Augmentation

Press START

Pressing the START key n Automatically purges and fills IAB n Automatically performs an in vivo calibration n Automatically selects most appropriate lead and trigger n Automatically sets inflation and deflation timing

Note: With a MAQUET/Datascope fiber-optic IAB, there is no need to zero. Calibration occurs automatically after pressing START. Operator may invoke a calibration anytime by pressing and holding CALIBRATE pressure key for 2 seconds, while assisting.

(84) mmHg

116 106 1:1

Aug Alarm IAB Frequency

Verify AUTO

2 2

Verify Aug. Alarm is set 10mmHg below patient’s augmented diastolic pressure (approx. 3 minutes after initiation of assist).

ECG

Rate

Lead: Auto - II

INITIAL SET-UP USING a coNventional IAB (CONTINUED)

bpm

0.5 mV

Trigger: ECG Arterial

Pressure

Source: Fiber-Optic

130

30 Inflation

Balloon Pressure

MEAN

Deflation

Auto

ECG

Rate

Lead: Auto - II

Augmentation

Trigger: ECG Arterial

Pressure

Source: Fiber-Optic

130

30 Inflation

Balloon Pressure Inflated

MEAN

Deflation

Auto

Deflated

102 52

mmHg

0.0

Augmentation

mmHg

106 1:1

Aug Alarm IAB Frequency

(84) mmHg

116 106 1:1

Aug Alarm IAB Frequency

Verify AUTO

Deflated

(84)

116

bpm

102 52

mmHg

0.0

Inflated

0.5 mV

2 2

Verify Aug. Alarm is set 10mmHg below patient’s augmented diastolic pressure (approx. 3 minutes after initiation of assist).

Press START

Pressing the START key n Automatically purges and fills IAB n Automatically selects most appropriate lead and trigger n Automatically sets inflation and deflation timing | 13 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

CARDIOSAVE SET-UP

| 14 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

CARDIOSAVE operation MODES Auto Operation Mode Automatic lead and trigger selection Automatic and continuous inflation and deflation timing management - User has ability to fine-tune deflation timing n Automatic management of irregular rhythms n Automatic in vivo calibration (when using a MAQUET/Datascope fiber-optic IAB) n n

Semi-Auto Operation Mode Operator selects most appropriate lead and trigger source n Operator establishes timing, then CARDIOSAVE automatically adjusts timing with heart rate and rhythm changes n Automatic management of irregular rhythms n Automatic in vivo calibration (when using a MAQUET/Datascope fiber-optic IAB) n

CARDIOSAVE OPERATION

CARDIOSAVE MONITOR DISPLAY AND TOUCHSCREEN ECG

Rate

Lead: Auto - II

bpm

0.5 mV

Trigger: ECG Arterial

Pressure

Source: Fiber-Optic

130

30 Inflation

Balloon Pressure Inflated

Deflated

MEAN

Deflation

Auto

102 52

mmHg

0.0

Augmentation

(84)

OPERATION MODE

116

Trigger

| 15 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

IAB IABFrequency Frequency

ECG

1:1

E CG

Standby

Start Start

Augmentation

Timing

Max

Inflation

1:2

Pressure

Direct

Pressure

Deflation

1:3

Off

Thresholds

Pacer V/AV

Pressure Threshold

Pacer A

Auto Pacer Detection

Internal

Default Lock Screen

Monitor Display

Sources Sources

106 1:1

2 2

Calibrate Pressure Hold 2 Sec.

mmHg

Aug Alarm IAB Frequency

Semi Auto

Auto

Hold 2 Sec.

Open Close Menus

Preferences

106 Ref Line

IAB Fill Hold 2 Sec.

Freeze Display

Aug Alarm Alarm

Print Strip Hold For Continuous

Touchscreen

CARDIOSAVE OPERATION

| 16 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

CARDIOSAVE LOCK SCREEN FEATURE OPERATION MODE

OPERATION MODE

Semi Auto

Auto

Calibrate Pressure

Standby

Start Start

Semi Semi Auto

Auto

Calibrate Pressure

Hold 2 Sec.

Trigger

Sources Sources

IAB IABFrequency Frequency

ECG

E CG

Timing

Max

Inflation

Direct

Sources

Pressure

Pacer A

Pressure Threshold

Pacer A

Auto

Open Close Menus

Preferences

Hold 2 Sec.

Inflation

Screen is locked 1:3

Deflation Off

to unlock press Unlock Screen button

Auto Pacer Detection

Internal

Default Lock Screen

Timing

Max

Thresholds

Pacer V/AV

Pacer Detection

Internal

Startt Star

Augmentation

1:2

Direct

Pressure Threshold

1:1

Pressure

Off

IAB IAB Frequency Frequency

ECG

Deflation

1:3

Thresholds

Pacer V/AV

Trigger

ECG

1:2

Pressure

Augmentation

1:1

Standby

Hold 2 Sec.

Default

106 Ref Line

IAB Fill Hold 2 Sec.

Freeze Display

Aug Alarm Alarm

Print Strip

Unlock Lock Screen Screen

Hold For Continuous

Hold 2 Sec.

Open Close Menus

Preferences

106 Ref Line

IAB Fill

Freeze Display

Hold 2 Sec.

Touchscreen Unlocked

Touchscreen Locked

Touchscreen will Lock: n Automatically after 2 minutes of inactivity n When operator presses LOCK SCREEN key for 2 seconds

Touchscreen will Unlock: n Automatically with any Technical, High, Medium, or Low Priority Alarm n When operator presses UNLOCK SCREEN key

Aug Alarm

Print Strip Hold For Continuous

Cardiosave TRIGGERS Triggering

CARDIOSAVE Triggers

A Trigger is the signal that CARDIOSAVE uses to identify the beginning of the next cardiac cycle n When CARDIOSAVE recognizes the trigger event, it will deflate the balloon if not already deflated n Trigger Source keys are only active while in Semi-Auto operation mode

ECG Trigger event is the R-Wave n Trigger of choice when an adequate R-Wave is present n Pacer spikes are automatically rejected

Pressure Trigger event is the systolic upstroke n Trigger of choice (with a regular rhythm) when an adequate R-Wave is not present n A fixed pressure threshold can be manually set while in Semi-Auto operation mode Pacer V/AV Trigger event is the Ventricular pacer spike n Typically used when ECG triggering is unsuccessful and a V or AV pacer is being used n Must be 100% paced n Only available in Semi-Auto operation mode Pacer A Trigger event is the R-Wave n Recommended only if atrial pacer tails are interfering with R-Wave detection while in ECG trigger n Only available in Semi-Auto operation mode Internal Trigger event is asynchronous at a fixed rate of 80 BPM n Only used when there is no mechanical cardiac cycle (i.e.: cardiopulmonary bypass or asystole) n Rate can be adjusted from 40 to 120 BPM n Only available in Semi-Auto operation mode

| 17 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

CARDIOSAVE OPERATION

| 18 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

THEORY OF COUNTERPULSATION THERAPY

Inflation: increases supply of oxygen to the myocardium.

Deflation: decreases demand for oxygen by the left ventricle.

How it works

Balloon inflates at onset of diastole (when aortic valve closes)

Displaces blood, causing an increase in aortic pressure

Benefits

Balloon deflates just prior to systolic ejection (before aortic valve opens) Results in a rapid decrease in aortic pressure

Increases coronary artery perfusion

Increases mean arterial pressure

n n

Decreases afterload Decreases cardiac workload Increases cardiac output

Timing Timing refers to the positioning of inflate and deflate points on the arterial pressure waveform.

Diastolic Augmentation

Proper IABP Timing

Unassisted Systole

INFLATION n O ccurs at the dicrotic notch n Appears as a sharp “V” n Ideally diastolic augmentation rises above systole DEFLATION Occurs just prior to systolic ejection n Results in a reduction in assisted end diastolic pressure n Results in a reduction in assisted systolic pressure n

| 19 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

One Cardiac Cycle

Unassisted End Diastolic Pressure

Assisted Systole

Assisted End Diastolic Pressure

CARDIOSAVE OPERATION

| 20 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |

TIMING ERRORS Early Inflation

Diastolic Augmentation Unassisted Systole

Assisted Systole

Physiologic Effects Potential premature closure of aortic valve

Inflation of IAB prior to aortic valve closure.

Waveform characteristics

Potential increase in LVEDV/LVEDP/PCWP

Inflation of IAB prior to dicrotic notch

n n

iastolic augmentation encroaches onto D systole (may be unable to distinguish)

Increased left ventricular wall stress or afterload

Aortic regurgitation

Increased MVO2 demand

Dicrotic Notch

Late Inflation Diastolic Augmentation Unassisted Systole

Assisted Systole

Inflation of IAB markedly after closure of aortic valve. Waveform characteristics Inflation of IAB after dicrotic notch

n n

Absence of sharp “V” Sub-optimal diastolic augmentation

Aortic Valve Closure

Dicrotic Notch

Physiologic Effects Sub-optimal coronary artery perfusion

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