1. Performer® CPB

2. Objectives Preview of our newest pump platform
Overview of Performer ® CPB features
Clarify difference between 1.0 and 1.5 versions
Help you become aware of capital cycles

3. The Product
A comprehensive application of all required Heart Lung machine pumping systems, safety systems, and monitoring systems to sustain virtually all phases of extracorporeal support.

4. Customer Dynamics
There are currently three major suppliers of heart lung platforms (Sorin, Terumo, and Maquet)
These machines are typically in service up to ten years
Some customers / competitors will attempt to bundle with disposables
The introduction of Performer™ CPB is a major new leverage for Medtronic

5. A Strong Heritage from RanD
New OR Procedure Opportunities
Regional Cancer Therapies
Future ICU Based Therapies

6. RanD Located in Europe’s “Medical Device Valley”
Sorin/ Dideco/ COBE HQ
Sorin-Bellco
B. Braun
Tyco-Mallinckrodt
Baxter-Miramed
Gambro-Hospal
Fresenius-Biofil

7. We Have Always Had The Ability To Invest In Today’s Legacy Technology
From Solid-State
To Microprocessor Controlled
Technology Driven or in Support of Future Cardiac Surgery’s Needs?

8. Performer™ CPB
Compatible Today for All Procedures/ Built For The Future
All the Functionality of Existing Systems in the Smallest Footprint
Adaptable to New Disposable Configurations / Bringing the Circuit Closer to the Patient
Integrated Data Management Systems
Procedure Flexible & Feature Loaded

9. Performer ® CPB V1.0 Resting Heart®
Based on Performer™ LRT Platform
Arterial Bio-Pump®
Designed to run RHS only
Integrated Active Air Removal; VARD software enabled
Optimized Safety Systems
Servo Mechanisms for VARD and Negative Venous Pressure
Variable Dosing (ratios) on Cardioplegia 15:1
Standard items 3 timers, 8 Pressure and Temperatures
Sat Hct with in-vivo calibration
Transonic Flow Probe with bubble detection (ABD)
Electric Pump Height Adjustment
User Friendly Operation
Upgradeable
Competitively Priced

10. Performer ® CPB V1.5 Conventional - Future
Bio-Pump® Arterial Pump
Additional User Screen Configuration for Conventional Mode
Software (GUI) updates
New Remote Level Detectors; Upper and Lower
Servo Function Between Level and Bio-Pump®
Arterial Line Clamp to prevent retrograde flow
Settable Oxygen Sat and Hct limits with alerts
More dose specific CPG settings
Calculator
Data management

11. Resting Heart®
Version 1.0
Conventional Version 1.5

12. Pump Systems 1 - 7.0 L/min Bio-Pump® Centrifugal Pump
L/min Max. Capacity Roller Pumps
L/min Max Capacity Roller Pumps
L/min Max Capacity Roller Pumps
1 – 0.6 L/min Max Capacity Roller Pumps
Meets your traditional requirements

13. User Friendly Interface
Intuitive Icon-based color display format
Alert/Alarm scrolling information bar
User-defined pump responses and alarms display
Supplemental information will not tile over operating screen
For optimum control and convenience

16. Arterial Pump Systems Proven Bio-Pump® System
Preload / Afterload Sensitive optimum control
Tested and effective air handling and retention
Now with non-invasive flow probe and bubble detection
Now with servo control
The tradition continues

17. Cardioplegia Options Traditional One Pump Two Pump Versatility
Fixed ratio double raceway
Two Pump Versatility
Slave control
Variable ratios on the fly
1:1 to 15:1 options
Software interface for dosing and timing
Micro-plegia (Future)
Integrated syringe pump
Future activation (V 2.0)
Greater adaptability and flexibility

18. Integrated Safety Systems
1 - AAR™ Venous Air Removal
8 - Pressure monitor/limiting devices
1 - Integrated SAT/Hct
1 - 3/8 inch arterial air detection device
1 - ¼ inch cardioplegia air detection device
8 - Temperature
measurement inputs
For more precise control and safety

19. Performer CPB Level Sensor
Impedance technology
Two Sensor Capable
Independently adjustable
User selectable Responses
Message only
Message and Coast
Alarm and Stop Flow
Optional Clamp capability

20. Arterial Clamp Pneumatic Driven Closed at Rest User Selectable
Retro Flow
Stopped flow
Low Level
Bubble Detection
Optional Feature

21. Integrated Safety Systems
RHS Servo Control Options
Venous Line Pressure to flow
AAR to flow
Programmable pump responses
Pressure Monitor/shut off to each pump
Conventional Servo Options
Reservoir level to flow
Auto clamp options
Retro flow
Low level
Greater stability of perfusion parameters

22. Data Management Trending data display Data download capability
Updates every minute
Records all critical parameters and settings
Data download capability
Compact Flash memory
RS232/RS485 output
Integral printer
Excel Macro
Report writer
Archival
Real Time Data Acquisition via External Program
To better meet your latest requirements

23. Size Does Matter …In Hospital Operating Rooms

24. Legacy Systems vs Performer™ CPB
System One
S 5

25. Virtual Part # P-CPB10 Double Check Order Customize Table Pack
Choose proper Rollers
Choose # of Temp Probes
Double Check Order
Change Quantities
Customize Table Pack
Start with CB4E96R5
Need GV100

26. Performer™ CPB Timeline
December 2004
Functional Prototypes
September 2005
CE Mark – 1st EU Human Cases Ongoing
510K submission
March 2006
FDA 510K Clearance March 18th
Commercial Release March 31st 2006
December 2006
File FDA 510K for Version 1.5
Early 2007
Expected Conventional Bio-Pump CPB Availability
- Not available for sale

27. Summary Version 1.0 is for Resting Heart only
Includes servo control of BioPump® to both:
Venous line pressure
Venous Air Removal Device (VARD)
Smallest footprint ever offered
Cardioplegia up to 15:1 ratios using 2 Pumps
Now in use in US ~450+ cases completed