Product Comparison AUTOTRANSFUSION CELL SEPARATOR SALES INFORMATION Product

Product Comparison AUTOTRANSFUSION CELL SEPARATOR SALES INFORMATION Product Comparison (Internal Use Only - CONFIDENTIAL) Electa 6. 0 Sales Information 1

Product Comparison Distribution of Product Key Success Factors (KSF) in Cardiac and Not Cardiac segment Electa 6. 0 Sales Information 2

Electa (6. 0) 主要特点Main features • • • Product Comparison High performances高性能: multi-point Buffy-coat detector, Latham bowl (55 -125 -175 -225 ml)—多点CDD探头/多型号离心杯 On-line processing quality control在线洗涤质量控制: Hct IN&OUT indication, wash quality indication –HCT离心杯进出血探头，FPH探头 Complete data management system彻底意义的数据管理系统: smart card & Electa Dbase for PC database creation, integrated needle printer for immediate reports—可檫写式记忆卡/电脑数据库软件/内置针式打印机即打报告 Ease of set-up安装简单: cassette organizer, automatic pump loading, automatic bowl size and protocol acquisition –盒式管道/自动压管/杯号识别及模式确认 Ease of use使用简单: color display and simplified user interface, help on line, auto-start function—彩色显示和简单的用户界面/在线帮助/自动启动 Versatility功能灵活多样性: – Operating modes: FA/A/SA/M -- 作模式（自动/半自动/手动等） – 24 dedicated automatic programs for ATS – 24种ATS自动模式 – Automatic PPP-PRP procedures (24 dedicated programs)—自动PPP/PRP – possibility to highly personalize the system—可以高度个性化设定系统 Direct draw直接抽血 (10 -100 ml/min in priming) & transfer bag—血液分离功能 Ideal to support emergencies理想的紧急时使用: max pump flow rate in ATS 1000 ml/min, adjustable—最大泵速 1000 ml/min，且可调 High transportability移动灵活性高, reduced dimensions, low weight, integrated vacuum pump—体积小/重心低/内置负压吸引泵 Auto-diagnostic function自我诊断功能 Software simulator模拟软件 as fundamental training tool—培训的良好 具 Electa 6. 0 Sales Information 3

Electa (6. 0) Product Comparison Main features • • • High performances: multi-point Buffy-coat detector, Latham bowl (55 -125 -175 -225 ml) On-line processing quality control: Hct IN&OUT indication, wash quality indication Complete data management system: smart card & Electa Dbase for PC database creation, integrated needle printer for immediate reports Ease of set-up: cassette organizer, automatic pump loading, automatic bowl size and protocol acquisition Ease of use: color display and simplified user interface, help on line, auto-start function Versatility: – Operating modes: FA/A/SA/M – 24 dedicated automatic programs for ATS – Automatic PPP-PRP procedures (24 dedicated programs) – possibility to highly personalize the system Direct draw (10 -100 ml/min in priming) & transfer bag Ideal to support emergencies: max pump flow rate in ATS 1000 ml/min, adjustable High transportability, reduced dimensions, low weight, integrated vacuum pump Auto-diagnostic function Software simulator as fundamental training tool Electa 6. 0 Sales Information 4

Product Comparison Product comparison according to KSF Electa 6. 0 Sales Information 5

Product Comparison Electa 6. 0 Sales Information 6

LOW HIGH Product Comparison LOW HIGH Electa 6. 0 Sales Information 7

Product Comparison COMPACT - Advanced Main features • • Operating modes: A/M Programmability: – – • • 24 dedicated automatic programs for ATS Automatic PPP-PRP procedures (24 dedicated programs) No direct draw Ideal to support emergencies: max pump flow rate in ATS 1000 ml/min, adjustable Quite difficult to set-up: color coding but no cassette organizer and manual selection of bowl size LATHAM bowl sizes 55 -125 -175 -225 ml High transportability Modular vacuum pump Auto-diagnostic function Software simulator Electa 6. 0 Sales Information 8

Product Comparison Electa 6. 0 Sales Information 9

Product Comparison Electa 6. 0: autotransfusion cell separator KSF comparison Electa 6. 0 vs Compact Advanced • • • Ease of use – easier to set-up: cassette organizer, automatic pump loading, automatic bowl and protocol selection – easier user interface: display color allows to immediately understand what is happening in every operative situation, complete warning and alarm messages, clear software structure – possibility to personalize the programs structure by excluding programs that are not used (all possibilities can be achieved: from 1 program to 12 per each bowl). – HELP ON LINE function: a manual always open on the right page Performances --> Strong innovation – New multipoint buffy-coat detector allowing • Higher Hct thanks to differentiated bowl filling optimization according to the bowl size. • Improved wash quality due to the higher level of Buffy-coat • improved PLT collection efficiency in sequestration procedures – No RBC loss during concentration phase due to the possibility to control the filling level with multi-point check point Automation – improved safety through new sophisticate detectors: blood loss, empty line clamped, waste bag level – integrated weighting system for blood weighting and auto-start function (total automation) Electa 6. 0 Sales Information 10

Product Comparison Electa 6. 0: autotransfusion cell separator KSF comparison Electa 6. 0 vs Compact Advanced • • PRP – improved flexibility and efficiency of PRP procedures: direct draw and transfer bag – improved automation in PPP and PRP 1 procedures and improved semi-automation in PRP 2 procedure (where the user must change manually the clamps position) Procedure traceability -->Strong innovation – Complete system for data management and procedures traceability: integrated PRINTER or SMART CARD SYSTEM to store and statistically analyze data on PC through Electa DBase software Blood quality monitoring -->Strong innovation – HCT detector allowing on line monitoring of blood concentration during the priming phase (INLET Hct) and during the empty phase (OUTLET Hct). – WASH QUALITY detector allowing on line monitoring of FPH (and other dangerous components present in the plasma) removal during the washing phase, as well as monitoring the transparency of the line going to the waste bag Transportability – Integrated vacuum pump – higher manouevrability: 4 directional wheels to facilitate small displacements in the O. R. as well as long transportation – new ergonomic cart for transportation of material (kits, saline bags etc. . ) Electa 6. 0 Sales Information 11

Product Comparison BRAT 2 Main features • • • • Operating modes: A/SA/M Programmability – 10 dedicated programs for ATS – Semi-automatic PRP procedures (1 dedicated program) – high versatility due to the possibility to highly personalize the system Direct draw (25 -200 ml/min in filling) Max pump flow rate in ATS 1300 ml/min BAYLOR bowl sizes 135 -250 ml Very fast processing system both in routine and in emergencies Easy set-up: cassette organizer, automatic pump loading and unloading CRIT-LINE sensor: Hct detector for collected RBC (optional) Big dimensions, high weight, low transportability Integrated vacuum pump Integrated needle printer No auto-diagnostic function Software simulator Electa 6. 0 Sales Information 12

Product Comparison BRAT 2 POSITIVE POINTS • Very easy to set up • Prompt in emergencies thanks to high processing speed • Fast processing also in routine due to Baylor bowl features • High degree of personalization (possibility to exclude alarms) • Integrated printer and vacuum pump • CRIT -LINE system: Hct detector for collected RBC (optional) • Direct draw NEGATIVE POINTS • Big and heavy equipment • Only 2 bowl sizes: 135 -250 ml • No auto-diagnostic • Perception of lower washing efficiency due to Baylor bowl geometry Electa 6. 0 Sales Information 13

Product Comparison Electa 6. 0 Sales Information 14

• • • How to sell against BRAT 2 Electa 6. 0 positive points vs Brat 2 Product Comparison Ease of use – Ergonomic tray helps creating a working base during set-up phase – Easier user interface and simpler approach: color display for immediate comprehension of the operative situation, more SOFT KEYS allow less hidden levels. – Help on line is not present in the BRAT 2: a manual always open on the right page, an invaluable aid for the customer during alarm situations or normal run phases Performances – Perception of higher wash quality, due to Latham bowl vs Baylor bowl – 4 bowl sizes for maximum flexibility, allow offering a solution in all kind of surgery and all patients, also low bleeding cases and in pediatric patients (55 ml bowl) – New BFY coat detector allowing to monitor BFY when rising and optimizing Hct per each bowl size and PLT efficiency during sequestration procedures – Wide range of accessories, indicated also for the not cardiac segment. Specific products for the orthopedic segment (i. e. START-IT system, fluid collection bags, microgoccia filters, etc). Automation – Higher safety measures: blood loss detector, waste bag filling level, clamped line sensor – Auto-start function (selectable), according to the volume in the reservoir (volume programmable by the user). Function not present in the BRAT 2 – Automatic bowl size and protocols loading vs manual protocols selection according to bowl size – 24 ATS programs vs 10 – 24 automatic SEQ programs vs 1 semi-automatic SEQ program – Auto-diagnostic function to immediately understand technical problems and equipment status, facilitating the job of the field service and of the hospital biomedical service Electa 6. 0 Sales Information 15

• • How to sell against BRAT 2 Electa 6. 0 positive points vs Brat 2 Product Comparison PRP – Higher pump flow control during SEQ procedures (10 -100 ml/min, 10 ml/min step vs 25 -200 ml/min, 25 ml/min step) – 6 automatic programs per each bowl size vs 1 semi-automatic program Blood quality monitoring – Hct IN sensor monitoring ‘’ON LINE’’, continuously, the blood entering inside the bowl vs non inlet indication. This information allows to control step by step the concentration phase – Hct OUT indication referred to each bowl, medium indications available on the reports. No need of having an external disposable, no added costs to the wash set, on-line calibration with physiological solution on the cassette. Hct sensor always present vs optional and expensive feature – Wash quality indication allowing to monitor step by step both the washing efficiency in terms of % removal of harmful components (FPH, anticoagulant, plasmatic proteins etc. . ) and the transparency of the line to the waste bag. No similar indication available in the Brat 2 Transportability – Small dimensions and low weight to increase transportability and facilitate installation/demonstrations (very important outside the cardiac surgery, in particular in orthopedics). BRAT 2 is heavy and big equipment, offering much less manoeuvrability inside and outside the O. R. Procedures traceability – 6 procedures instead of 1 contemporarily stored in the internal memory. This allows to download data once per day and not at the end of each intervention, without loosing any data. – Innovative smart card system and data management SW (Electa DBase) to store and elaborate data on PC. Graphic and statistical analysis, a real instrument for the user to monitor the ATS activity. – Different kinds of reports can be generated (general, detailed, alarms & modifications) – Memorization and reporting of all the procedure data, also bowl details, modifications and warnings Electa 6. 0 Sales Information 16

How to sell against BRAT 2 Brat 2 positive points vs Electa 6. 0 • • • Product Comparison Ease of use – Automatic loading/unloading of pump loop. With the new pump head it is extremely easy to unload the pump segment, even if not automatic Performances – Higher Hct due to Baylor bowl vs Latham bowl. – Very fast processing due to max pump speed 1300 ml/min and to higher pump flow rates allowed thanks to Baylor bowl geometry – Wide range of accessories focused on the cardiac segment Automation – possibility to exclude some detectors and the relative alarm messages Blood quality monitoring – Hct detector precise in the range 20%-80% with 3%standard deviation points vs Electa Hct indication having as target 10% standard deviation Procedures traceability – PC connection through Microsoft hyper-terminal available. Forecasted for future developments in Electa – all data from detectors immediately available on display vs necessity of printing reports. Forecasted for future developments in Electa 6. 0 Sales Information 17

Product Comparison CATS Main Features • • • • Operating mode: A 7 ATS programs 1 program for PPP and PRP collection 2 rapid transfer programs, 1 cryo-wash program Direct draw Max pump flow: prime 350 ml/min, wash 400 ml/min, empty 190 ml/min BELT SYSTEM Fat elimination system Easy to set-up Help on line Big and heavy equipment - low transportability Modular vacuum pump External printer (optional) Battery for net falls Auto-diagnostic function Electa 6. 0 Sales Information 18

CATS Product Comparison POSITIVE POINTS • Innovative concept and mechanism: BELT SYSTEM • Easy to set-up • Help on line present in all phases • No need of bowl sizes (higher flexibility also in low bleeding cases) • High Hct (usually >60%) • Clamped line sensor • Rapid transfer programs • Cryo-washing programs • Optional thermal printer • Battery for net falls • Auto-diagnostic NEGATIVE POINTS • Not fast enough in emergencies because flows can not be adjusted manually on a significant range and the maximum flow is 350 ml/min for shed blood • Priming with saline solution needed (some minutes) • Lower wash quality vs Latham bowl due to belt geometry (blood dilution more than real washing) • A certain amount of concentrated RBC necessary to begin the procedure (approx. 30 ml RBC = 300 ml blood at 10%Hct). • 30 ml RBC must be kept in the belt till the end of the procedure • Not efficient PRP collection due to the belt system geometry Electa 6. 0 Sales Information 19

Product Comparison Electa 6. 0 Sales Information 20

How to sell against CATS Electa 6. 0 positive points vs CATS • • Product Comparison Ease of use – Easier user interface and simpler approach: color display for immediate comprehension of the operative situation. CATS is easy to set-up, not so easy to use – Help on line always present to help user during alarm situations or normal run phases: a manual always open on the right page, an invaluable aid for the customer during alarm situations or normal run phases. In CATS only in set-up. Performances – higher wash quality due to Latham bowl versus Belt system (that only concentrates without really removing harmful components, except fat) – Electa is fast when it is needed, adjustable manually also in Automatic mode (1000 ml/min max pump flow). CATS can not be used in emergencies: automatically regulated processing speed is not fast enough in the CATS when big quantities must be treated in short times since it can not be strongly adjusted manually – No priming needed in Electa (only if using Hct detector), can be easily skipped in emergencies. For the CATS system it is always necessary to fill the belt with saline solution (some minutes) – A certain amount of concentrated RBC necessary to begin the procedure (approx. 30 ml RBC = 300 ml blood at 10%Hct). 30 ml RBC must be kept in the belt till the end of the procedure – CATS reaches normally a higher Hct (usually > 60%): sometimes such concentrated blood must be diluted with saline solution to be reinfused (no clinical advantage, dilution is time consuming and there is a high risk to loose sterility) Electa 6. 0 Sales Information 21

How to sell against CATS Electa 6. 0 positive points vs CATS • • • Product Comparison Automation – Wider functioning modes range with possibility to adjust flows in all phases according to specific needs. – Fast processing when needed (emergencies) thanks to high pump speed (1000 ml/min max in all phases vs automatically adjusted, max 350 ml/min in prime, 400 m/min in wash and 190 in empty) – Auto-start function – 24 ATS programs (vs 7 in the CATS), 24 SEQ programs (vs 1 in the CATS) PRP – Higher pump flow control during SEQ procedures (10 -100 ml/min, 10 ml/min step vs 45 -105 ml/min) – Much more complicate manual procedure, due to the clamps a adjustments in the belt system – Not efficient PRP collection due to the belt system geometry Blood quality monitoring – Hct IN sensor monitoring ‘’ON LINE’’, continuously, the blood entering inside the bowl vs non inlet indication in the CATS. This information allows to control step by step the concentration phase – Hct OUT indication referred to each bowl continuously displayed during empty phase and medium indications available on the reports. No Hct out indication in the CATS. – Wash quality indication allowing to monitor step by step both the washing efficiency in terms of % removal of harmful components (FPH, anticoagulant, plasmatic proteins etc. . ) and the transparency of the line to the waste bag. No similar indication available in the CATS Electa 6. 0 Sales Information 22

How to sell against CATS Electa 6. 0 positive points vs CATS • • Product Comparison Transportability – Integrated vacuum pump vs external vacuum regulator – Small dimensions and low weight to increase transportability and facilitate installation/demonstrations (very important outside the cardiac surgery, in particular in orthopedics). CATS is heavy and big equipment, offering much less manoeuvrability inside and outside the O. R. Procedures traceability – 6 procedures instead of 1 contemporarily stored in the internal memory. This allows to download data once per day and not at the end of each intervention. No data lost – Innovative smart card system and data management SW (Electa DBase) to store and elaborate data on PC. Graphic and statistical analysis, a real instrument for the user to monitor the ATS activity. – Different kinds of reports can be generated (general, detailed, alarms & modifications) – Memorization and reporting of all the procedure data, also bowl details, modifications and alarm messages – Integrated needle printer vs external thermal printer. No cables outside, no external holder, permanent printing according to legal recommendations. Electa 6. 0 Sales Information 23

How to sell against CATS positive points vs Electa 6. 0 • • Product Comparison Automation – No need of bowl sizes (higher flexibility). With 4 bowl sizes we can treat small amounts of blood (only 30 -35 ml RBC necessary to begin washing with a 55 ml bowl – Rapid transfer programs, but with Electa it is possible to reproduce this behaviour by programming to 0 the wash volume. – Cryo-washing programs – Battery net falls. It is not a real positive point since it only allows to displace without switching off the equipment. Centrifuge and pump can not work when CATS is on battery. Performances – Continuous flow should allow to increase processing speed since it allows to contemporarily prime, wash and reinfuse. In the reality the impossibility to manually increase flows (only a restricted modification range is possible) prevents from having fast processing when it is really needed, in emergencies. – higher Hct usually > 60% thanks to the belt system and the CCD buffy-coat detector even if sometimes this is not an advantage because: • • there is no clinical indication stating that 60% is better than 50%. Parameters to be measured are others like percentage removals and RBC functionality after centrifugation such concentrated blood must be diluted with saline solution to be reinfused (dilution is time consuming and there is a high risk to loose sterility) – Fat elimination mechanism. Fresenius is aggressive on this point even if: • • there at present no clinical studies IN VIVO at present there is no clear demonstration of the negative effects the quantities typical in orthopedic surgery can be dangerous Electa 6. 0 Sales Information 24

CELL SAVER 5 Product Comparison Main features • • • Operating modes: FA/M High automation: auto-start system, effluent quality sensor Programmability: – 2 dedicated programs for ATS – Manual SEQ procedure (1 dedicated program) Direct draw (10 -250 ml/min in filling) Max pump flow rate in ATS 1000 ml/min LATHAM bowl sizes 125 -225 ml Easy set-up: guided set-up, cassette organizer, automatic bowl size detection and protocol selection Quite good transportability Modular vacuum pump available External thermal printer (optional) No auto-diagnostic Electa 6. 0 Sales Information 25

Product Comparison CELL SAVER 5 NEGATIVE POINTS • Two only bowl sizes: 125 -225 ml • Two only preexisting programs • Manual sequestration procedures • Very rigid fully automatic mode: auto start not excludable • No auto-diagnostic POSITIVE POINTS • Automatic self-starting system • Easy set-up: cassette organizer, selfselecting protocols • Effluent quality sensor • Waste bag filling level alarm • Clamped line sensor • Cassette organizer • Bowl optic sensor • Air detector • Effluent quality sensor • Clamped line system Electa 6. 0 Sales Information 26

Product Comparison Electa 6. 0 Sales Information 27

How to sell against CS 5 Electa 6. 0 positive points vs CS 5 • • • Product Comparison Ease of use – Ergonomic tray helps creating a working base during set-up phase – Easier user interface and simpler approach: color display for immediate comprehension of the operative situation. – Help on line always present to help user during alarm situations or normal run phases: a manual always open on the right page, an invaluable aid for the customer during alarm situations or normal run phases Performances – 4 bowl sizes for maximum flexibility, allow offering a solution in all kind of surgery and all patients, also low bleeding cases and in pediatric patients (55 ml bowl). Heamonetics has a new 75 ml bowl but only for Hemolite 2 (not suitable for CS 5) – New BFY coat detector allowing to monitor BFY when rising and optimizing Hct per each bowl size and PLT efficiency during sequestration procedures Automation – Higher safety measures: blood loss detector, waste bag filling level, clamped line sensor – Wider functioning modes range (in Electa also A and SA) – Auto-start function to be set as an option (flexible because selectable) also in the automatic mode, not set by default in automatic mode as in the CS 5 – 6 ATS programs per each bowl size (vs 1 per each bowl size) – 6 SEQ programs per each bowl size (vs 1 in total in the CS 5) – Auto-diagnostic to immediately understand technical problems and equipment status facilitating the job of the field service and of the hospital biomedical service Electa 6. 0 Sales Information 28

How to sell against CS 5 Electa 6. 0 positive points vs CS 5 • • Product Comparison PRP – Higher pump flow control during SEQ procedures (10 -100 ml/min, 10 ml/min step vs 25 -200 ml/min, 25 ml/min step) – 6 automatic programs per each bowl size vs totally manual controlled procedures Blood quality monitoring – Hct IN sensor monitoring ‘’ON LINE’’, continuously, the blood entering inside the bowl vs non inlet indication. This information allows to control step by step the concentration phase – Hct OUT indication referred to each bowl continuously displayed during empty phase and medium indications available on the reports. No Hct out indication in the CSV – Wash quality indication allowing to monitor step by step both the washing efficiency in terms of % removal of harmful components (FPH, anticoagulant, plasmatic proteins etc. . ) and the transparency of the line to the waste bag. No similar indication available in the CSV Transportability – Integrated vacuum pump Procedures traceability – 6 procedures instead of 1 contemporarily stored in the internal memory. This allows to download data once per day and not at the end of each intervention. No data lost – Innovative smart card system and data management SW (Electa DBase) to store and elaborate data on PC. Graphic and statistical analysis, a real instrument for the user to monitor the ATS activity. – Different kinds of reports can be generated (general, detailed, alarms & modifications) – Memorization and reporting of all the procedure data, also bowl details, modifications and alarm messages – Integrated needle printer vs external thermal printer. No cables outside, no external holder, permanent printing according to legal recommendations. Electa 6. 0 Sales Information 29

How to sell against CS 5 positive points vs Electa 6. 0 • Product Comparison Automation – Automatic parameters optimization system (BFY coat sensor + Effluent line sensor = flows and wash volume adjustment). Flows during filling and washing phase are automatically adjusted by the machine. Nevertheless, as a negative aspect, in case of manual pump flow adjustment the effluent line sensor is immediately deactivated. – Possibility to increase the wash volume (by 500 ml) according to the effluent quality detector indication or to decrease it in case the line is particularly clean. With Electa 6. 0 the ‘’clever washing function’’ and the messages related to the wash quality sensor allows to decrease the procedure time in case of low hemolysis and to assure great quality also in case of high hemolysis Electa 6. 0 Sales Information 30

ORTHOPAT Main Features • • • Product Comparison Operating mode: Automatic only No programmability – only 1 preexisting functioning program No PRP Low processing speed --> 2000 ml of fluid treated in 1 hour (!!!!!) As specified in the user guide, Orthopat is absolutely not indicated for massive volumes treatment, or in case of emergencies when fast processing is needed Based on a new functioning principle: the Dynamic disk (variable volume separation chamber) Small dimensions, high transportability (unit placed on an I. V. pole) Easy to set-up, all preconnected (no cassette organizer, no pump) Integrated vacuum source, but only available for post operative blood collection No procedures’ traceability, no memorization of data No auto-diagnostic functions Electa 6. 0 Sales Information 31

Product Comparison ORTHOPAT NEGATIVE POINTS POSITIVE POINTS • • • easy to use only ‘’disk’’ size means one only disposable new concept: : dynamic disk principle based on a variable volume separation chamber small and portable allows post operative blood collection and washing • • slow processing, ideal only in case of very low volume treatment flows not adjustable --> not suitable for emergencies and high volumes treatment can not be used for intraoperative --> 2 separate kits for intra and postoperative --> cost effectiveness ? ? ? !!!! WASH QUALITY ? ? ? Washing phase is more a dilution than a real washing Electa 6. 0 Sales Information 32

Product Comparison ORTHOPAT working principle Electa 6. 0 Sales Information 33

Product Comparison Electa 6. 0 Sales Information 34

How to sell against ORTHOPAT Electa 6. 0 positive points vs ORTHOPAT • • • Product Comparison Ease of use – Easier user interface: color display to immediately understand what is happening in every operative situation, complete warning and alarm messages, clear software structure. On the ORTHOPAT display only few information and graphic representation of collected and treated volumes: not clear and not immediate for easy and fast understanding – Help on line always available to help the user during alarm situations or normal operating phases: a user guide always open on the right page. No similar function present in ORTHOPAT Performances – BT 894 guarantees a high quality filtration with three filtrating layers: defoaming 30 ppi poliurethane (internal) + 40 micron no woven (intermediate) + 120 micron (external) poliesthere net. The ORTHOPAT reservoir cannot guarantee the same quality: pre-filtration layer in poliesthere-poliutehtane 250 microns+ internal 200 microns poliesthere filter. Furthermore 4 liters capacity of BT 894 versus 2 liters is much more indicated to store the highly diluted blood typical of the intraoperative phase during orthopedic procedures. – Higher wash quality due to Latham bowl versus Dynamic disk. When the hemolysis concentration is high, ORTHOPAT’s disk is not be as efficient as a Latham bowl in removing FPH and other dangerous components: the saline is not really passing through the RBC (as it happens with the Latham bowl structure) but only diluting the concentrated RBC. Automation – Electa pump flow is adjustable in the range 0 -1000 ml/min: it is possible to adjust flows run time, to treat massive bleedings and emergency cases as well as routine cases. The ORTHOPAT as specified in the manual, is not able to fast process the blood: flows and processing speed are not adjustable. – Electa has specific programs and solutions for every kind of surgery; ORTHOPAT is indicated only in orthopedics, specifically for postoperative blood collection and washing. Electa 6. 0 Sales Information 35

How to sell against ORTHOPAT Electa 6. 0 positive points vs ORTHOPAT • Product Comparison – Higher safety measures: waste bag filling level to safeguard the quality of the collected blood, blood loss detector and clamped line sensor to prevent form Biohazard risk and blood bag explosion. No safety detector present in the ORTHOPAT – Auto-start function (flexible because selectable) according to the volume in the reservoir (flexible because the volume is programmable by the user). Automatic start in the ORTHOPAT is not programmable. – 24 ATS programs, 6 per each bowl size. Programs available for every kind of surgery and operating situation. In the ORTHOPAT only one program is available, with no possibility to change flows and increase processing speed – Self-diagnostics to detect automatically technical problems and check equipment status, facilitating the job of the field service and of the hospital biomedical service PRP – 24 automatic SEQ programs, 6 SEQ per each bowl size vs NO POSSIBILITY FOR SEQUESTRATION in the ORTHOPAT Electa 6. 0 Sales Information 36

How to sell against ORTHOPAT Electa 6. 0 positive points vs ORTHOPAT • • • Product Comparison Blood quality monitoring – Hct IN sensor monitoring ‘’ON LINE’’, continuously, the blood entering the bowl vs no inlet indication in the ORTHOPAT. This information allows to control step by step the concentration phase – Hct OUT indication referred to each bowl continuously displayed during empty phase; intermediate indications available on the reports. No Hct out indication in the ORTHOPAT. – Wash quality indication allowing to monitor step by step both the washing efficiency in terms of % removal of harmful components (FPH, anticoagulant, plasmatic proteins etc. . ) and the transparency of the line leading to the waste bag. No similar indication available in the ORTHOPAT Transportability – Integrated vacuum pump vs external additional vacuum regulator of ORTHOPAT during intraoperative procedures. Only during postoperative blood collection the internal vacuum source is available Procedures traceability – 6 procedures contemporarily stored in the internal memory. This allows to download data once per day and not at the end of each intervention. No data lost when the equipment is switched off. When switching off the ORTHOPAT, all data are lost. It is necessary to leave the equipment ON, retiring the sock and using the battery instead of switching it off. – Innovative smart card system and data management SW (Electa DBase) to store and elaborate data on PC. Graphic and statistical analysis, a real instrument for the user to monitor the ATS activity. – Different kinds of reports can be generated (general, detailed, alarms & modifications) – Memorization and reporting of all the procedure data, including bowl details, modifications and warnings. – Integrated needle printer vs external thermal printer. No cables outside, no external holder, permanent printing in compliance with legal recommendations. – No data management and reporting functions in ORTHOPAT. When it is switched off all data are lost !!!! Electa 6. 0 Sales Information 37

• • How to sell against ORTHOPAT positive points vs Electa 6. 0 Product Comparison Ease of use – Preconnected ATS kit. This is positive since it minimizes manipulations, but on the contrary it includes a very high risk. ORTHOPAT can not face the emergency cases: in case you need to treat the blood with another equipment, there is no access port and no possibility to get the blood out of the reservoir--> as a consequence, the patient can die (real case reported by a German customer) Performances – the dynamic disk principle allows to have only one disposable. But the fact that it does not allow to treat high fluid volumes and to process rapidly the blood makes this features an incredible limit, not an advantage – allows intra and post operative blood collection and washing with only one disposable. It increases the cost effectiveness of the procedure. On a theoretical way this is true, but in practice the ORTHOPAT decreases the COST-EFFECTIVENESS of the procedure. In fact, in many cases you need one set for the intra and one different set for post operative and you need also two different equipment. The ORTHOPAT cannot be the only equipment in an hospital with a major orthopedic surgery: it can not face intraoperative phases when there is a considerable RBC mass to treat (revisions) or in case the volume in the reservoir is too high (very common in the intraoperative during all the orthopedic procedures to have low concentration and high dilution). As it is indicated in the manual, it is not advisable to dilute too much the blood in the reservoir because it increases the processing time and decreases the final Hct. Automation – new concept: : dynamic disk principle based on a variable volume separation chamber. Every new functioning principle attracts the customers, but in case the disadvantages are real and evident the perception changes from ‘’new and irresistible’’ to ‘’interesting as a concept, but not useful and worse than previous systems’’ Transportability – small and portable. The body of the equipment is located on an I. V. pole. Very easy to transport and move 38 Electa 6. 0 Sales Information

SEQUESTRA 1000 Main Features • • Product Comparison Operating modes: A/SA/M Programmability – 3 ATS preexisting programs – PPP and PRP automatic programs Direct draw Max pump flow rate 1000 ml/min LATHAM bowl sizes: 125 -225 -375 ml Quite difficult to set-up: no cassette organizer Big dedicated cart - low transportability External printer OUT OF PRODUCTION SINCE YEAR 2001 Electa 6. 0 Sales Information 39

Product Comparison Electa 6. 0 Sales Information 40

• • How to sell against SEQUESTRA Electa 6. 0 positive points vs SEQUESTRA Product Comparison Ease of use – easier to set-up: cassette organizer, automatic pump loading, automatic bowl and protocol selection – easier user interface: display color allows to immediately understand what is happening in every operative situation, complete warning and alarm messages, clear software structure – Help on line always present to help user during alarm situations or normal run phases: a manual always open on the right page, an invaluable aid for the customer during alarm situations or normal run phases. Not present in SEQUESTRA Performances – 4 bowl sizes for maximum flexibility, allow offering a solution in all kind of surgery and all patients, also low bleeding cases and in pediatric patients (55 ml bowl). – New BFY coat detector allowing to monitor BFY when rising and optimizing Hct per each bowl size and PLT efficiency during sequestration procedures Automation – Wider functioning modes range and programs for all surgical applications. – Higher safety measures: blood loss detector, waste bag filling level, clamped line sensor – Auto-start function (flexible because selectable) according to the volume in the reservoir (flexible because the volume is programmable by the user) – Automatic bowl size and protocols loading vs manual protocols selection according to bowl size – 24 ATS programs – 24 automatic SEQ programs – Auto-diagnostic to immediately understand technical problems and equipment status facilitating the job of the field service and of the hospital biomedical service PRP – Higher pump flow control during SEQ procedures (10 -100 ml/min, 10 ml/min step) Electa 6. 0 Sales Information 41

How to sell against SEQUESTRA Electa 6. 0 positive points vs SEQUESTRA • • • Product Comparison Blood quality monitoring – Hct IN sensor monitoring ‘’ON LINE’’, continuously, the blood entering inside the bowl vs non inlet indication in the SEQUESTRA. This information allows to control step by step the concentration phase – Hct OUT indication referred to each bowl continuously displayed during empty phase and medium indications available on the reports. No Hct out indication in the SEQUESTRA. – Wash quality indication allowing to monitor step by step both the washing efficiency in terms of % removal of harmful components (FPH, anticoagulant, plasmatic proteins etc. . ) and the transparency of the line to the waste bag. No similar indication available in the SEQUESTRA Transportability – Integrated vacuum pump vs external vacuum regulator – Small dimensions and low weight to increase transportability and facilitate installation/demonstrations (very important outside the cardiac surgery, in particular in orthopedics). SEQUESTRA is a heavy and big equipment with an enormous cart, offering much less manoeuvrability inside and outside the O. R. Procedures traceability – 6 procedures instead of 1 contemporarily stored in the internal memory. This allows to download data once per day and not at the end of each intervention. No data lost – Innovative smart card system and data management SW (Electa DBase) to store and elaborate data on PC. Graphic and statistical analysis, a real instrument for the user to monitor the ATS acitvity. – Different kinds of reports can be generated (general, detailed, alarms & modifications) – Memorization and reporting of all the procedure data, also bowl details, modifications and alarm messages – Integrated needle printer vs external printer. No cables outside, no external holder, permanent printing according to legal recommendations Electa 6. 0 Sales Information 42

How to sell against SEQUESTRA positive points vs Electa 6. 0 • Product Comparison PRP – No specific positive points related to the product but, as positive advertising, strong focus on SEQ procedures and many scientific articles and publications about this subject Electa 6. 0 Sales Information 43

AUTOLOG Main Features • • • Product Comparison Operating mode: A Programmability – 1 preexisting program Manual PRP Max pump flow rate max 1000 ml/min GRANADE bowl size: 125 ml Small dimensions, high transportability Very easy to set-up (no cassette organizer) No vacuum pump No procedures’ traceability No auto-diagnostic function Electa 6. 0 Sales Information 44

Product Comparison Electa 6. 0 Sales Information 45

How to sell against AUTOLOG Electa 6. 0 positive points vs AUTOLOG • • • Product Comparison Ease of use – easier to set-up: cassette organizer, automatic pump loading, automatic bowl and protocol selection – easier user interface: display color allows to immediately understand what is happening in every operative situation, complete warning and alarm messages, clear software structure – Help on line always present to help user during alarm situations or normal run phases: a manual always open on the right page, an invaluable aid for the customer during alarm situations or normal run phases. Not present in AUTOLOG Performances – Higher wash quality due to Latham bowl versus Granade bowl. In high hemolized cases AUTOLOG is absolutely not suitable Automation – Wider functioning modes range and programs. – Higher safety measures: blood loss detector, waste bag filling level, clamped line sensor – Auto-start function (flexible because selectable) according to the volume in the reservoir (flexible because the volume is programmable by the user) – 24 ATS programs, 6 per each bowl size (vs 1 in total) – 24 automatic SEQ programs, 6 SEQ per each bowl size (vs none automatic) – Auto-diagnostic to immediately understand technical problems and equipment status facilitating the job of the field service and of the hospital biomedical service Electa 6. 0 Sales Information 46

How to sell against AUTOLOG Electa 6. 0 positive points vs AUTOLOG • • Product Comparison PRP – Automatic SEQ procedures vs completely manually controlled procedures – High pump flow control during SEQ procedures (10 -100 ml/min, 10 ml/min step) Blood quality monitoring – Hct IN sensor monitoring ‘’ON LINE’’, continuously, the blood entering inside the bowl vs non inlet indication in the AUTOLOG. This information allows to control step by step the concentration phase – Hct OUT indication referred to each bowl continuously displayed during empty phase and medium indications available on the reports. No Hct out indication in the AUTOLOG. – Wash quality indication allowing to monitor step by step both the washing efficiency in terms of % removal of harmful components (FPH, anticoagulant, plasmatic proteins etc. . ) and the transparency of the line to the waste bag. No similar indication available in the AUTOLOG Transportability – Integrated vacuum pump vs external additional vacuum regulator of AUTOLOG Procedures traceability – 6 procedures instead of 1 contemporarily stored in the internal memory. This allows to download data once per day and not at the end of each intervention. No data lost – Innovative smart card system and data management SW (Electa DBase) to store and elaborate data on PC. Graphic and statistical analysis, a real instrument for the user to monitor the ATS acitvity. – Different kinds of reports can be generated (general, detailed, alarms & modifications) – Memorization and reporting of all the procedure data, also bowl details, modifications and alarm messages – Integrated needle printer vs external thermal printer. No cables outside, no external holder, permanent printing according to legal recommendations. – No one data management and reporting function in AUTOLOG 47 Electa 6. 0 Sales Information

How to sell against AUTOLOG positive points vs Electa 6. 0 • • Product Comparison Ease of use – Autolog is extremely simple since it is not sophisticated. Of course it is also extremely poor in quality and functions. Transportability – Lower dimensions of the equipment-cart system Electa 6. 0 Sales Information 48