**Exhibit 10.1**

**Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.**

** **

**SUPPLY AGREEMENT**

**by and among**

**PLC SYSTEMS INC.,**

**PLC MEDICAL SYSTEMS, INC.**

**and**

**EDWARDS LIFESCIENCES LLC**

**dated**

**March 9, 2006**

 

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**TABLE OF CONTENTS**
|                                       | ** ** | ** **                               | ** ** | ** ** | ** ** |
|---------------------------------------|------------|------------------------------------------|------------|------------|------------|
| ARTICLE I Definitions                 |       |                                     |       |
|                                  |       |                                     |       |       |       |
| ARTICLE II Appointment                |       |                                     |       |
|                                  |       |                                     |       |       |       |
| Section 2.1.                          |       | Appointment                              |       |       |       |
| Section 2.2.                          |       | Future Laser Power Sources               |       |       |       |
| Section 2.3.                          |       | Product Accessories.                     |       |       |       |
| Section 2.4.                          |       | Endo Handpiece Inventory.                |       |       |       |
|                                  |       |                                     |       |       |       |
| ARTICLE III  Obligations of PLC       |       |                                     |       |
|                                  |       |                                     |       |       |       |
| Section 3.1.                          |       | Labeling of  Laser Power Sources         |       |       |       |
| Section 3.2.                          |       | Manufacturer’s Warranty             |       |       |       |
| Section 3.3.                          |       | Insurance                                |       |       |       |
| Section 3.4.                          |       | Production of  User Manuals              |       |       |       |
| Section 3.5.                          |       | Costs and  Expenses                      |       |       |       |
| Section 3.6.                          |       | Legal Requirements                       |       |       |       |
| Section 3.7.                          |       | Facilities                               |       |       |       |
| Section 3.8.                          |       | Inspection                               |       |       |       |
| Section 3.9.                          |       | Adverse  Experience Reporting            |       |       |       |
| Section 3.10.                         |       | Records                                  |       |       |       |
| Section 3.11.                         |       | Recall                                   |       |       |       |
| Section 3.12.                         |       | Transfer of  Regulatory Approvals.       |       |       |       |
|                                  |       |                                     |       |       |       |
| ARTICLE IV  Purchase Arrangements     |       |                                     |       |
|                                  |       |                                     |       |       |       |
| Section 4.1.                          |       | Purchaser  Orders; Product Quantities    |       |       |       |
| Section 4.2.                          |       | Placement of Orders                      |       |       |       |
| Section 4.3.                          |       | PLC License                              |       |       |       |
| Section 4.4.                          |       | Failure to Supply                        |       |       |       |
| Section 4.5.                          |       | Technology  Escrow and Transfer          |       |       |       |
|                                  |       |                                     |       |       |       |
| ARTICLE V  Pricing, Shipping, Payment |       |                                     |       |
|                                  |       |                                     |       |       |       |
| Section 5.1.                          |       | Retrofitted  Model 3 Laser Power Source. |       |       |       |
| Section 5.2.                          |       | New Model 3  Laser Power Source          |       |       |       |
| Section 5.3.                          |       | Shipping; Taxes                          |       |       |       |
| Section 5.4.                          |       | Payment                                  |       |       |       |

 

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|                                                                            |   |                                                   |   |   |   |
|----------------------------------------------------------------------------|--------|--------------------------------------------------------|--------|--------|--------|
| ARTICLE VI  Termination;                                                   |   |                                                   |   |
|                                                                       |   |                                                   |   |   |   |
| Section 6.1.                                                               |   | Immediate Termination                                  |   |   |   |
| Section 6.2.                                                               |   | Effect of  Termination                                 |   |   |   |
|                                                                       |   |                                                   |   |   |   |
| ARTICLE VII  Warranties and Indemnification                                |   |                                                   |   |
|                                                                       |   |                                                   |   |   |   |
| Section 7.1.                                                               |   | Warranties                                             |   |   |   |
| Section 7.2.                                                               |   | Indemnification  by PLC                                |   |   |   |
| Section 7.3.                                                               |   | Indemnification by Edwards                             |   |   |   |
| Section 7.4.                                                               |   | Indemnification Procedures                             |   |   |   |
| Section 7.5.                                                               |   | Limitations on  Liability                              |   |   |   |
|                                                                       |   |                                                   |   |   |   |
| ARTICLE VIII  Trademarks and Confidentiality; Intellectual Property Rights |   |                                                   |   |
|                                                                       |   |                                                   |   |   |   |
| Section 8.1.                                                               |   | Trademarks.                                            |   |   |   |
| Section 8.2.                                                               |   | Confidential Information                               |   |   |   |
|                                                                       |   |                                                   |   |   |   |
| ARTICLE IX  MISCELLANEOUS                                                  |   |                                                   |   |
|                                                                       |   |                                                   |   |   |   |
| Section 9.1.                                                               |   | Relationship                                           |   |   |   |
| Section 9.2.                                                               |   | No Conflict                                            |   |   |   |
| Section 9.3.                                                               |   | Governing Law                                          |   |   |   |
| Section 9.4.                                                               |   | Escalation                                             |   |   |   |
| Section 9.5.                                                               |   | Jurisdiction and Consent to Service                    |   |   |   |
| Section 9.6.                                                               |   | Notices                                                |   |   |   |
| Section 9.7.                                                               |   | Interpretation                                         |   |   |   |
| Section 9.8.                                                               |   | Severability                                           |   |   |   |
| Section 9.9.                                                               |   | Counterparts                                           |   |   |   |
| Section 9.10.                                                              |   | Entire  Agreement; No Third Party Beneficiaries        |   |   |   |
| Section 9.11.                                                              |   | Amendments and  Modifications; Waivers and Extensions. |   |   |   |
| Section 9.12.                                                              |   | Assignment                                             |   |   |   |
| Section 9.13.                                                              |   | Schedules                                              |   |   |   |
| Section 9.14.                                                              |   | Expenses                                               |   |   |   |
| Section 9.15.                                                              |   | No Consequential or Punitive Damages                   |   |   |   |
| Section 9.16.                                                              |   | Force Majeure                                          |   |   |   |

 

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| Exhibits        |   |                                    |   |   |   |
|-----------------|--------|-----------------------------------------|--------|--------|--------|
|            |   |                                    |   |   |   |
| Exhibit A       |   | Laser 3 Power Source Specifications     |   |   |   |
|            |   |                                    |   |   |   |
| Schedules       |   |                                    |   |   |   |
|            |   |                                    |   |   |   |
| Schedule 2.1(a) |   | Universal  Functionality Specifications |   |   |   |
|            |   |                                    |   |   |   |
| Schedule 2.4    |   | Endo Handpiece  Inventory               |   |   |   |
|            |   |                                    |   |   |   |
| Schedule 3.12   |   | Regulatory  Approvals                   |   |   |   |

 

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**SUPPLY AGREEMENT**

SUPPLY AGREEMENT, dated as of March 9, 2006 (this“Agreement”), by and among Edwards Lifesciences LLC, a Delaware limitedliability company (“Edwards”), PLC Systems Inc., a Yukon Territory corporation(“PLC Parent”), and PLC Medical Systems, Inc., a Delaware corporation (“PLC”),which is a wholly owned subsidiary of PLC Parent.

WHEREAS, Edwards is a company in the medical devicesfield with experience in the commercialization and distribution of medicaldevices, including laser-based products relating to the surgical treatment ofatrial fibrillation and atrial flutter;

WHEREAS, PLC has experience in the development and manufacturingof laser-based products for medical uses and desires to supply to Edwards, andEdwards desires to purchase from PLC, such laser-based products.

NOW, THEREFORE, in consideration of the mutualagreements and covenants contained herein and for other good and valuableconsideration, the receipt and sufficiency of which are hereby acknowledged,and intending to be legally bound hereby, the Parties hereto agree as follows:

**ARTICLE I**

**Definitions**

As used in this Agreement, the following terms shallhave the following meanings:

“Agreement” shall have the meaning set forth in therecitals.

“Complaint” means any written, electronic, or oralcommunication that alleges deficiencies related to the identity, quality,durability, reliability, safety, effectiveness, or performance of a Laser PowerSource after it is released for distribution.

“Damages” shall have the meaning set forth in Section 7.2.

“Dispute” shall have the meaning set forth in Section 9.4.

“Edwards” shall have the meaning set forth in therecitals.

“Effective Date” shall mean the date of thisAgreement.

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“Escalation Notice” shall have the meaning set forthin Section 9.4.

“Escrow Release Event” shall have the meaning setforth in Section 4.3.

“FDA” means the United States Food and Drug Administrationand any successor agency thereto.

“Field of Use” shall mean the surgical treatment ofatrial fibrillation and atrial flutter, including, without limitation,minimally invasive surgical treatment of atrial fibrillation and atrialflutter.

“Firm Forecast” shall have the meaning set forth in Section 4.1.

“Force Majeure Event” shall have the meaning set forthin Section 9.16.

“Forecast” shall have the meaning set forth in Section 4.1.

“Indemnified Party” shall have the meaning set forthin Section 7.4.

“Indemnifying Party” shall have the meaning set forthin Section 7.4.

“Intellectual Property” shall mean all intellectualproperty rights of any nature or form of protection of a similar nature orhaving equivalent or similar effect to any of the foregoing, including, withoutlimitation:  (a) inventions,discoveries, processes, designs, techniques, developments, technology, andrelated improvements, whether or not patentable; (b) United Statespatents, patent applications, divisionals, continuations, reissues, renewals,registrations, confirmations, re-examinations, certificates of inventorship,extensions, and the like, and any provisional applications of any such patentsor patent applications, and any foreign or international equivalent of any ofthe foregoing; (c) any word, name, symbol, color, designation, or deviceor any combination thereof, including, without limitation, any United States orpending trademark, trade dress, service mark, service name, trade name, brandname, logo, domain name, or business symbol, and any foreign or internationalequivalent of any of the foregoing and all goodwill associated therewith; (d) anywork, whether or not registered in the United States or elsewhere, thatincorporates, is based upon, derived from, or otherwise uses any intellectualproperty, including, without limitation, mechanical and electronic designdrawings (including, without limitation, computer-aided design files),specification, software (including, without limitation, documentation andobject and source code listing), processes, technical or engineering data, testprocedures, schematics, writings, materials, products, artwork, packaging andadvertising materials; and (e) technical, scientific, and other know-howand information, trade secrets,

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knowledge, technology,means, methods, processed, practices, formulas, assembly procedures, computerprograms, apparatuses, specifications, books, records, production data,publications, databases, reports, manuals, data and results, in written,electronic, or any other form not known or hereafter developed.

“Invention(s)” as used herein shall include, withoutrestriction or limitation, any and all devices, processes (including withoutlimitation processes of using devices or of manufacturing such devices),compositions of matter, computer software, chemical formulations orcompositions or products whether patentable or unpatentable, and any and allwritten materials or other works which may be subject to copyright, which arereduced to practice, conceived or written during the Term of this Agreement,and which is developed as a result of work done by either or both Parties underthis Agreement.

“Laser Power Source” shall mean a medical laser powersource and the associated control system (including all necessary hardware andsoftware) for tissue ablation in the Field of Use.

“Legal Requirements” means all laws, statutes,ordinances, codes, rules, regulations, published standards, permits, judgments,decrees, writs, injunctions, rulings, orders and other requirements of allPublic Authorities and shall include, without limitation, all applicablerequirements of QSR/ISO.

“Model 3 Laser Power Source” shall mean the LaserPower Source currently identified by PLC to Edwards as its Model 3 Laser PowerSource based on the specification set forth on Exhibit A attachedhereto, and shall include Retrofitted Model 3 Laser Power Sources and New Model3 Laser Power Sources.

“New Model 3 Laser Transfer Price” shall have themeaning set forth in Section 5.2.

“New Model 3 Laser Power Sources” shall have themeaning set forth in Section 2.1(b).

“New Laser Warranty Period” shall have the meaning setforth in Section 3.2(a).

“Next Generation Laser Power Source” shall have themeaning set forth in Section 2.2(c).

“Person” means any individual, partnership,corporation, limited liability company, joint venture, association, joint-stockcompany, trust, incorporated organization, government or agency or politicalsubdivision thereof, or other entity.

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“PLC” shall have the meaning set forth in therecitals.

“PLC Parent” shall have the meaning set forth in therecitals.

“PLC License” shall have the meaning set forth in Section 4.3.

“PLC Laser Power Source Intellectual Property” shallhave the meaning set forth in Section 4.3.

“Public Authority” means any supranational, national,regional, state or local government, court, governmental agency, authority,board, bureau, instrumentality or regulatory body, and shall include, withoutlimitation, the FDA.

“QSR/ISO” means the Quality System Regulation, as suchterm is defined by the FDA which is in force and effect or hereafter adopted bythe FDA, and the ISO 9001 requirements as established for the EuropeanCommunity, or other applicable regulatory requirements and standards, asamended or supplemented from time to time.

“Retrofitted Laser Warranty Period” shall have themeaning set forth in Section 3.2(a).

“Retrofitted Model 3 Laser Power Source” shall havethe meaning set forth in Section 2.1(a)

“Supply Breach” shall have the meaning set forth in Section 4.4(a).

“Termination Letter” shall have the meaning set forthin Section 2.2(b).

“Territory” shall mean the entire world.

**ARTICLE II**

**Appointment**

Section 2.1.   *Appointment.*   Subject to the terms and conditionscontained in this Agreement, Edwards hereby appoints PLC asEdward’s exclusive manufacturer and supplier of Model 3 Laser Power Sources inthe Territory. Subject to the terms and conditions contained in this Agreement,PLC agrees to provide Model 3 Laser Power Sources to Edwards on the followingbasis:

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(a)   With respect to Model 3 Laser Power Sourcesbearing serial numbers 26 through 43 and 45 through 118 (each, a “RetrofittedModel 3 Laser Power Source”), PLC will retrofit each such Laser Power Source ina timely manner in accordance with the Universal Functionality specificationscurrently described on Schedule 2.1(a) hereto (the “UniversalFunctionality Specifications”), if and when such Laser Power Sources aredelivered to PLC by Edwards for retrofitting.

(b)   PLC agrees to manufacture and sell additionalModel 3 Laser Power Sources (“New Model 3 Laser Power Sources”) for which  Edwards has placed and not cancelled ordersin accordance with this Agreement, up to such number of units (estimated by theParties at approximately [**]) which may reasonably be manufactured by PLCbased on the inventory of component parts that PLC has on hand from time totime or can reasonably procure. Such New Model 3 Laser Power Sources shall bemanufactured by PLC in accordance with the Universal Functionality Specifications;provided, however, that in the event that Edwards and PLC agree on amodification of  such specifications, theUniversal Functionality Specifications shall be deemed so amended to the extentthat Edwards agrees in writing to accept any increased costs and other expensesreasonably charged by PLC for such modification.

Section 2.2.   *Future Laser Power Sources.*   Edwards shall notpurchase, offer for sale or otherwise utilize in the Field of Use anyLaser Power Sources manufactured or engineered by any person other than PLCwithout compliance with the provisions of this Section or as a result ofan uncured Supply Breach (as defined under Section 4.4). In the event thatEdwards desires to sell or otherwise utilize in the Field of Use a Laser PowerSource other than a Model 3 Laser Power Source (each, a “Future Laser PowerSource”),

(a)   it shall notify PLC of any need forengineering services with respect to such Future Laser Power Source, which suchnotice shall set forth the specifications and related material terms reasonablydesired by Edwards for such Future Laser Power Source. PLC shall have a periodof sixty days from the receipt of such notice to quote Edwards a price andother terms for the engineering of such Future Laser Power Source. If Edwardsdoes not accept such quote it shall be free to obtain such engineering servicesfrom another party (which such services Edwards may investigate during theabove referenced 60-day period) provided that neither Edwards nor any ofits Affiliates shall obtain such engineering services from any other partyunless it has, following receipt of a proposal from (or acceptance of Edwards’proposal by) such other party, offered to PLC the right to provide suchengineering services on the terms offered by such other party in such proposal,and PLC has not accepted such offer in writing within five days; and

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(b)   it shall notify PLC of its need for asupplier of such Future Laser Power Source, which such notice shall set forththe specifications and related material terms reasonably desired by Edwards forthe supply of such Future Laser Power Source to Edwards. PLC shall have aperiod of sixty days from the receipt of such notice to quote Edwards atransfer price and other material terms. If Edwards does not accept such quoteit shall be free to obtain such supply from another party (which such supplyEdwards may investigate during the above referenced 60-day period)provided that neither Edwards nor any of its Affiliates shall obtain suchsupply from any other party unless it has, following receipt of a proposal from(or acceptance of Edwards’ proposal by) such other party, offered to PLC theright to provide such supply on the terms offered by such other party in suchproposal, and PLC has not accepted such offer in writing within five days.  PLC shall have no obligation during the abovereferenced sixty day period to assist or otherwise cooperate with any thirdparty from whom Edwards is seeking a quote under Section 2.1(a) orthis Section 2.1(b). Thereafter, such obligations shall be as set forth inthis Agreement and (if any) in the letter agreement dated as of the same dateof this Agreement among the parties to this Agreement (the “Termination Letter”)

(c)   The foregoing provisions shall apply withrespect to Future Laser Power Sources through and including the Next GenerationLaser Power Source. For purposes hereof, “Next Generation Laser Power Source”shall mean the first to be sold of either (i) the first Laser Power Sourceafter the Model 3 Laser Power Source which Edwards in good faith believes willbe a successor product to the Model 3 Laser Power Source, and not just anupgrade or enhancement of the Model 3 Laser Power Source (to which this Section 2.2shall also apply), or (ii) the first Laser Power Source sold following theexhaustion of the inventory of component parts referenced in Section 2.1(b) above.

Section 2.3.   *Product Accessories.*   PLC shall supply such customaryproduct accessories, including, without limitation cablesand an operation manual, for each Laser Power Source that it supplies toEdwards. The price for the product accessories is included in the Laser PowerSource price set forth in Section 5.2 (or as otherwise provided pursuantto Section 2.2).

Section 2.4.   *Endo Handpiece Inventory.*   To the extent needed byEdwards, Edwards will purchase from PLC at the same invoiceprice paid by PLC any parts inventory (provided such inventory is in goodworking order) with respect to Endo Handpieces presently on hand at PLC priorto purchasing any such parts (or equivalents thereof) from any other person. PLC’sinventory of these parts is listed on Schedule 2.4 attached hereto.

 

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**ARTICLE III**

**Obligations of PLC**

Section 3.1.            *Labeling of Laser PowerSources.*   PLC shall and PLCParent shall cause PLC to provide and to assume regulatoryresponsibility for all finished Model 3 Laser Power Source-related labelingsuch that it complies with all applicable laws and regulations in the UnitedStates and the European Union during the term of this Agreement. All labelingfor Model 3 Laser Power Sources shall include the statement “Distributed byEdwards Lifesciences LLC, Manufactured by PLC Medical Systems, Inc” or, ifapplicable, a similar statement reflecting the appropriate Edwards entity in agiven jurisdisction (provided that upon reasonable notification from Edwardsfollowing registration of the Model 3 Laser Power Source with Edwards’ notifiedbody, such label shall include the alternative statement “Manufactured forEdwards Lifesciences LLC by PLC Medical Systems, Inc.”)  For all countries of the Territory excludingthe United States and the countries of the European Union, Edwards shall provideto PLC camera-ready labels in compliance with all regulatory requirementsrelated to such labeling for Model 3 Laser Power Sources to be sold in suchcountries, which shall be affixed to Model 3 Laser Power Sources by PLC. PLCshall label, as appropriate and in accordance with applicable laws andregulations, Model 3 Laser Power Sources to be sold in the United States or inany country of the European Union.

*Section 3.2.           *Manufacturer’sWarranty.

(a)   PLC shall, and PLC Parent shall cause PLC to,provide the manufacturer’s warranty described in this Section 3.2 toEdwards on all New Model 3 Laser Power Sources for a period (the “New LaserWarranty Period”) consisting of the earlier of (i) [**] from the date ofdelivery of the Laser Power Source by Edwards to its customer, or (ii) [**]from the date of shipment from PLC to Edwards of such Laser Power Source. SuchLaser Power Sources must be delivered to PLC for repair or replacement for thiswarranty to be valid and enforceable. PLC shall, and PLC Parent shall cause PLCto, provide the manufacturer’s warranty described in this Section 3.2 toEdwards with respect to the new functionality provided by the retrofitactivities described in Section 2.1(a) above on all Retrofitted Model3 Laser Power Sources for a period (the “Retrofitted Laser Warranty Period”)consisting of [**] from the date of shipment from PLC to Edwards of suchRetrofitted Laser Power Source.

(b)   Subject to the restrictions in (c) below,PLC warrants to Edwards that all New Model 3 Laser Power Sources shall be freefrom defects in materials 

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and workmanship undernormal use and service during the New Laser Warranty Period (other thanmaterials and workmanship provided by Edwards or its Affiliates). Subject tothe restrictions in (c) below, PLC warrants to Edwards that the newfunctionality installed on Retrofitted Model 3 Laser Power Sources shall befree from defects in materials and workmanship under normal use and serviceduring the Retrofitted Laser Warranty Period (other than materials andworkmanship provided by Edwards or its Affiliates). PLC shall repair or replacesuch defective Laser Power Source at its reasonable option during theapplicable Laser Warranty Period, at its own cost and expense. PLC shall payall costs associated with shipping and transportation of the defective part orLaser Power Source if said defect appears during the applicable Laser WarrantyPeriod. Notwithstanding the previous sentence PLC shall not be responsible forany shipping and transportation costs for any parts or Laser Power Sources thatare not covered by the manufacturer’s warranty described in this Section 3.2,and Edwards shall pay, or reimburse PLC for, all such shipping andtransportation costs. For any product failure that appears after the expirationof the applicable Laser Warranty Period, Edwards shall pay PLC for all usualand reasonable charges of PLC to repair or replace such product failureincluding any shipping and transportation costs, if Edwards elects to have suchproduct failure repaired by PLC, in which case PLC shall in a timely mannerrepair or replace such defective Laser Power Source.

(c)   The warranties described in Section 3.2(a)-(b) shallnot cover failure due to negligence, accident, deliberate abuse, misuse, norimproper storage, installation and/or maintenance, nor components supplied byEdwards. Any use of a Laser Power Source inconsistent with such Laser PowerSource’s operating instructions and any modifications made to such Laser PowerSource shall void such warranty in its entirety. Such warranty does not coverany Laser Power Source which has been altered, serviced, repaired or changed inany manner whatsoever by anyone other than PLC, or an authorized servicerepresentative of PLC, provided, however, that such warranty shall not bevoided by proper installation of such Laser Power Source.

*Section 3.3.           *Insurance.

(a)   PLC shall and PLC Parent shall cause PLC toobtain and keep in force during the term of this Agreement product liabilityinsurance coverage in an amount not less than $10,000,000, and from an insurerrated A- or better by A.M. Best Company and in a form reasonablyacceptable to Edwards. During the term of this Agreement and for a period of[**]****following theexpiration or termination of this Agreement, such insurance coverage shallevidence Edwards and all of its Affiliates that sell Laser Power Sourcesmanufactured by PLC as additional insured entities and shall provide forwritten notification to Edwards by the insurer not less than 30 days prior tocancellation, expiration or modification. PLC shall and PLC 

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Parent shall cause PLC toprovide a certificate of insurance evidencing compliance with this Section 3.3(a) toEdwards within 30 days of the date hereof.

(b)   Edwards shall maintain product liabilityinsurance in an amount not less than $10,000,000 and from an insurer rated A-or better by A.M. Best Company during the term of this Agreement. Duringthe term of this Agreement and for a period of [**] following expiration ortermination of this Agreement, such insurance coverage shall evidence PLC andall of its Affiliates that manufacture Laser Power Sources as additionalinsured entities and shall provide for written notification to PLC by theinsurer not less than 30 days prior to cancellation, expiration or modification.Edwards shall provide PLC with a certificate of insurance evidencing compliancewith this Section 3.3(b) within 30 days of the date hereof.

Section 3.4.            *Production of User Manuals.*   PLCshall produce all English language user manuals for the Model 3 Laser PowerSources and such other language user manuals for the Model 3 Laser PowerSources as Edwards directs PLC to produce for the European Union, provided,however, that Edwards shall provide, at no cost to PLC, translation of all suchuser manuals and all end user interface menus that are not in English.

Section 3.5.            *Costs and Expenses.*   PLCshall and PLC Parent shall cause PLC to bear all the costs and expensesassociated with PLC’s obligations set forth in this Agreement.

Section 3.6.            *Legal Requirements.*   PLC and Edwards undertake tocomply with all applicable LegalRequirements and all applicable regulations of any Public Authority havingjurisdiction over the manufacturing, storage, import, export, handling or saleof Model 3 Laser Power Sources and materials or related to obtaining andmaintaining legal approval for the manufacture, storage, import, export,handling, marketing and sale of Model 3 Laser Power Sources. PLC shall manufactureeach Model 3 Laser Power Source pursuant to the specifications agreed to withEdwards and in accordance with all applicable Legal Requirements for the UnitedStates and the European Union. Notwithstanding the foregoing, the parties agreethat PLC shall not be responsible for conducting any pre-clinical or clinicalstudies or for obtaining any approvals in connection with the storage, import,export, handling, marketing or sale of Laser Power Sources. PLC acknowledgesthat it is familiar with and shall abide by QSR/ISO.

Section 3.7.            *Facilities.*   Model 3 Laser Power Sources shall bemanufactured by PLC at its facilityat Franklin, MA, or such other facility as may be reasonably determined by PLCand communicated to Edwards in writing. PLC represents and warrants that Model3 Laser Power Sources shall only be 

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manufactured at afacility which has been qualified by all applicable Public Authorities for themanufacture of such Laser Power Sources. Upon request by Edwards, PLC shallprovide to Edwards copies of the relevant licenses and permits with respect toall such facilities.

Section 3.8.            *Inspection.*   Upon the reasonable request of Edwards,PLC shall permit duly authorizedemployees of Edwards and, with the consent of PLC (not to be unreasonablywithheld), other representatives of Edwards, to inspect the facilities or itscontract facilities, procedures and capabilities to insure continued compliancewith this Agreement and applicable Legal Requirements; provided that PLC may,in its sole discretion, refuse to grant access to any areas of its facilitiesor manufacturing records to the extent that such access would jeopardize theconfidentiality of any of PLC’s or any third party’s proprietary technology notrelated to this Agreement.

Section 3.9.            *Adverse Experience Reporting*.   During and after theTerm of this Agreement, each Partyshall notify the other Parties in a reasonably timely fashion, or sooner ifrequired by law, of any information on any Complaint (howsoever obtained andfrom whatever source) associated with the clinical uses, studies,investigations, testing and marketing of Laser Power Sources. Each Party shallprovide the Other Party with reasonable assistance in investigating Complaints.Each Party shall further notify the other Parties immediately of any informationreceived regarding any threatened or pending action by any Public Authority,which may affect the safety and effectiveness claims of any Laser Power Source.Nothing contained herein shall be construed as restricting any Party’s right tomake a timely report of such matter to any Public Authority or take otheraction that it deems to be appropriate or required by applicable LegalRequirements.

Section 3.10.          *Records.*   All technical records relating to themanufacturing of any Laser Power Sourceby or on behalf of PLC shall be retained (i) in accordance with PLC’sinternal policies, a copy of which has been provided to Edwards, or, ifgreater,  (ii) for the periodrequired by any applicable Legal Requirements.

Section 3.11.          *Recall.*   The Parties hereto shall observe at all timesall Legal Requirements in order to maintainan effective system for the recall from the market of Model 3 Laser PowerSources. Notwithstanding anything herein to the contrary, if either PLC orEdwards deems it necessary to effect a recall of any Model 3 Laser PowerSource, it shall give the other Party reasonable notice of the circumstances ofsuch intended recall and an appropriate time to discuss and agree on suchintended recall. All costs of the recall shall be borne by the party at fault,e.g., PLC shall pay for a recall due to the Model 3 Laser Power Source notbeing manufactured under the QSR or if the Model 3 Laser Power Source does notmeet 

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specifications uponrelease from PLC, and Edwards shall pay for a recall due to the Model 3 LaserPower Source not being stored or installed under the QSR or if Edwards providesPLC with false or misleading labeling. Where a violation of the law occurs thatis not the fault of either PLC or Edwards, e.g., the Model 3 Laser Power Sourceis mishandled in a shipment by a common carrier, then PLC and Edwards shallshare the cost of the recall equally. In the event that agreement cannot bereached on effecting the recall within five (5) business days, the Partywho desires, in its reasonable judgment, to effect the recall may do so. Theother Party or Parties shall take no action contrary to the recall and shallcooperate fully with the Party effecting the recall.

Section 3.12.          *Transfer of Regulatory Approvals*.   In connection withthis Agreement and the transactionscontemplated hereby, PLC shall, to the extent permitted by applicable LegalRequirements, transfer to Edwards within thirty (30) days of the date hereof,all regulatory approvals held by PLC for Laser Power Sources, including withoutlimitation, all approvals and supporting documentation for the sale of LaserPowers Sources in the United States and, to the extent existing, Canada, Europeand any other jurisdictions, including all of the following:  (i) all documentation in support of 510(k) Pre-MarketNotification regulatory clearance(s) under 21 C.F.R. 807, and (ii) alldocumentation in support of CE Mark(s) for the Laser Power Sources,including, without limitation, in the case of (i) and (ii): all (A) submissionsand related correspondence with the FDA or applicable notified body, (B) technicalfiles, (C) justifications to file, (D) documentation to file, (E) engineeringsupporting documentation, (F) engineering change requests, (G) laserproduct reports, laser supplemental reports, laser abbreviated reports andlaser annual reports, and (H) and any other relevant documentation insupport of these regulatory clearances. Except as set forth on Schedule 3.12hereto, PLC hereby represents and warrants that the approvals and documentationwith respect to the 510(k) Pre-Market Notification are current withrespect to the Model 3 Laser Power Source through the specifications set forthin Exhibit A. PLC hereby covenants to perform its obligationsdescribed on Schedule 3.12 within thirty days after the date hereof.

**ARTICLE IV**

**Purchase Arrangements**

Section 4.1.            *Purchaser Orders; ProductQuantities*.   Edwards shall provide an updated twelve (12) month forecast (the “Forecast”)for****Laser Power Sources on orbefore the first day of the month preceding each calendar quarter. The Forecastis non-binding and will be used for planning purposes only, except for thefirst two (2) quarters within each Forecast (the “Firm Forecast”). TheForecast for the first quarter within the Firm Forecast cannot be changed andthe forecast for the second quarter within the Firm Forecast cannot bedecreased by more than [**] 

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percent ([**]%) when suchforecasted amount for the second quarter rolls forward and becomes theforecasted amount for the first quarter. Edwards shall be obligated topurchase, and shall submit a purchase order to purchase not less than [**]percent ([**]%) of the quantities of Laser Power Sources as specified for thefirst quarter of the most recent Firm Forecast. Subject to the foregoing,Edwards shall determine in its sole discretion the quantity of Laser PowerSources it shall forecast and purchase and there shall be no minimum purchaserequirements for any Laser Power Source. To the extent that the terms of anypurchase order and the terms of this Agreement conflict, the terms of thisAgreement shall control.

Section 4.2.            *Placement of Orders*.   Allorders for Laser Power Sources submitted by Edwards shall be initiated by writtenpurchase orders sent to PLC no later than the first day of the month precedingeach calendar quarter, which purchase orders shall specify the desired deliverydate (which shall not be later than 10 days before the end of a calendarquarter) and the Edwards Facility as the location for delivery in accordancewith Section 5.3. Quarterly purchase orders submitted to PLC by Edwardswill indicate the quantity of Laser Power Sources to be delivered for eachmonth of the quarter, provided, however, the quantity for any individual monthshall in no case be less than [**]% of the total to be delivered for the entirequarter. There shall be no upper limit on the quantity of Laser Power SourcesEdwards may order in a quarter, provided, however, PLC will have no liabilityunder this Agreement for failure to deliver, in a timely manner, any amount ofProduct in excess of [**]% of the quantity most recently forecasted pursuant toSection 4.1 for the quarter. PLC shall use commercially reasonable effortsto deliver Laser Power Sources on the agreed upon delivery dates set forth inaccepted purchase orders, but, in any event, shall make all deliveries withinten days of the agreed upon delivery dates set forth in accepted purchaseorders.

Section 4.3.            *PLC License*.   PLC hereby grantsto Edwards and its Affiliates a non-exclusive license (the “PLC License”), in the Territory,to all intellectual property owned by or licensed to PLC, to the extentsublicensable without cost to PLC, that PLC uses to develop, make or have madeLaser Power Sources for Edwards, including, without limitation, the right touse PLC’s manufacturing methods to manufacture Laser Power Sources (includingall necessary trade secrets, technical know-how and other intellectual propertyof PLC) (collectively, the “PLC Laser Power Source Intellectual Property”), tomake, have made, import, sell, market, or offer for sale, Laser Power Sourcesin the Field of Use that but for the license granted in this Section 4.3would infringe or misappropriate PLC Intellectual Property. Edwards covenantsnot to exercise the license granted under this Section 4.3 unless (i) aSupply Breach as described in Section 4.4 by PLC occurs, or (ii) PLCis not selected to engineer or supply Laser Power Sources pursuant to Section 2.2above (each, an “Escrow Release Event”); provided, however, that in the eventof an Escrow Release Event resulting from the failure of 

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PLC to be selected toprovide engineering services pursuant to Section 2.2(a), such licenseshall be for the limited purpose of enabling the person so selected to providesuch engineering services. Edwards agrees to require any licensee or sublicenseof PLC Laser Power Source Intellectual Property to enter into a confidentialityagreement that protects the PLC Laser Power Source Intellectual Property withthe same degree of care that Edwards uses to protect its own comparableconfidential information; provided that PLC shall be expressly named therein asa third party beneficiary of such agreement.

Section 4.4.            *Failure to Supply.*

(a)   In the event PLC (in each case, a “SupplyBreach”):  (i) refuses (including afailure to respond in a reasonably timely matter to a written inquiry,excluding a purchase order) to timely supply the Laser Power Source inaccordance with a timely issued purchase order that conforms to all theapplicable requirements of this Agreement or (ii) subject to the limitsset forth in Section 4.1 and 4.2, fails twice in any twelve (12) monthperiod to timely supply Edwards with at least [**] percent ([**]%) of thequantity of the Laser Power Sources forecasted for the first calendar quarterof any rolling Forecast (provided that Edwards orders at least [**] percent([**]%) of such forecasted quantity), Edwards shall have the right to use thePLC License granted above under Section 4.3. Notwithstanding theforegoing, any Supply Breach under Section 4.4(ii) above shall beexcused if such failure to supply is the direct result of (i) the failureof Edwards to timely supply the necessary quantity of laser diodes, opticsblocks or any other required Edwards supplied material to PLC within thespecified lead times necessary for PLC to timely manufacture the quantity ofproduct requested on Edwards purchase order; or (ii) the failure ofanother PLC supplier to supply an adequate quantity of materials for the LaserPower Sources through no fault of PLC, and where PLC has exercised commerciallyreasonable efforts to find an alternative source of supply for such materials.

(b)   In the event of an Escrow Release Event, theescrow described in Section 4.5 shall be released and Edwards may exercisethe license granted pursuant to Section 4.3.

Section 4.5.            *Technology Escrow andTransfer*.   PLC shall place the PLC Laser Power Source Intellectual Property in atechnology escrow arrangement with Iron Mountain. The information placed inescrow by PLC shall include all trade secrets, know-how, and other intellectualproperty to allow Edwards to manufacture the Laser Power Source (subject to Section 4.4(b))in the manner manufactured by PLC immediately prior to Edwards exercise of therights under the license granted under Section 4.3. PLC shall refresh theescrow in a prompt and timely manner with any new innovations or know-howdeveloped or acquired by 

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PLC that relate to theLaser Power Sources. Edwards shall have the right to periodically assess PLC’scompliance with PLC’s obligations under this section. All escrow fees shall bepaid by Edwards. In the event of an escrow release, (i) PLC shall provideEdwards with training in the use of the know-how and such other assistance asis reasonably required to enable Edwards to manufacture the Laser Power Sourcein the manner manufactured by PLC immediately prior to the exercise of suchrights by Edwards, and (ii) PLC shall transfer to Edwards at no cost toEdwards all movable assets used by PLC that are dedicated exclusively tomanufacture the Laser Power Source, in order to enable Edwards to manufacturethe Laser Power Source in the manner manufactured by PLC immediately prior tothe exercise of such rights by Edwards.

**ARTICLE V**

**Pricing, Shipping,Payment**

Section 5.1.            *Retrofitted Model 3 LaserPower Source.*   Edwards shall pay $[**] to retrofit each of the Retrofitted Model 3Laser Power Sources in accordance with the Universal FunctionalitySpecifications currently attached hereto as Schedule 2.1(a), plus shipping andinsurance costs incurred in connection with the shipment of such Model 3 LaserPower Source to PLC for retrofitting and the shipment of such Model 3 LaserPower Source by PLC to Edwards upon completion of such retrofitting. Except asset forth in Section 3.2 above, in the event that Retrofitted Model 3Laser Power Sources require repair or other work beyond retrofitting inaccordance with the Universal Functionality Specifications currently attachedhereto as Schedule 2.1(a) (including as a result of damage during shipmentto PLC, provided that such damage is not caused by PLC), PLC shall chargeEdwards its then standard rates for such work, or as otherwise agreed to by PLCand Edwards.

Section 5.2.            *New Model 3 Laser PowerSource.*   Edwards shall purchase the New Model 3 Laser Power Source from PLC for$[**] (the “New Model 3 Laser Transfer Price”); provided, however, that Edwardsshall provide laser diodes and optics blocks to PLC for timely incorporation byPLC into each Laser Power Source. These laser diodes and optics blocks shall beprovided by Edwards to PLC at no cost to PLC. The New Model 3 Laser TransferPrice shall be for the purchase of a Laser Power Source meeting the UniversalFunctionality Specifications currently attached hereto as Schedule 2.1(a) andshall be subject to increase in accordance with the “proviso” clause of thelast sentence of Section 2.1(b). Except as set forth in Section 3.2above, in the event that a New Model 3 Laser Transfer requires repair or otherwork (including without limitation post-delivery retrofitting), PLC shallcharge Edwards its then standard rates for such work, or as otherwise agreed toby PLC and Edwards.

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Section 5.3.            *Shipping; Taxes.*   PLCshall deliver Products directly to Edwards. Except as set forth in Section 5.1, all prices for Laser PowerSources shall be F.O.B. to a single facility of Edwards located in the UnitedStates, as designated in writing by Edwards (“Edwards Facility”), which EdwardsFacility may be changed to another facility in the United States by Edwardsupon advance written notice to PLC. The prices will not include any federal,state or local sales, use, excise or value added tax that may be applicable. IfPLC has the legal obligation to collect such taxes, the appropriate amountshall be added to Edwards’ invoice and paid by Edwards unless Edwards providesPLC with a valid tax exemption certificate authorized by the appropriate taxingauthority. PLC shall ship Laser Power Sources using the method oftransportation reasonably determined by PLC. Except as set forth in Section 5.1above, in all cases, title, risk of loss and all responsibility fortransportation, insurance and storage shall pass from PLC to Edwards upontransfer of finished Laser Power Sources from PLC to the Edwards Facility andafter such transfer PLC shall promptly issue an invoice related thereto toEdwards.

Section 5.4.            *Payment.*   Fullpayment shall be made by Edwards to PLC within sixty (60) days from the invoice date which shall be the shippingdate for Laser Power Sources to Edwards. In the event Edwards fails to timelypay more than four (4) invoices in any twelve month period, then paymentshall be due to PLC under this Section 5.4 within thirty (30) days fromsuch invoice date.

**ARTICLE VI**

**Termination;**

Section 6.1.            *Immediate Termination*.   ThisAgreement may be terminated by either Edwards or PLC immediately in the event (a) of any breachby the other Party of Section 3.3; (b) of any material breach by theother Party remaining uncured 60 days after written notice containing detailsof the breach has been delivered to the other Party; or (c) that the otherParty shall file for protection from its creditors under any applicableBankruptcy or insolvency laws, shall make an assignment for the benefit ofcreditors, or shall have a receiver appointed for its property.

Section 6.2.            *Effect of Termination*.   Withinthirty (30) days of  expiration or earlytermination of thisAgreement, PLC and PLC Parent shall return all Confidential Information ofEdwards, and vice versa, in its possession or under its control unlessotherwise provided for in this Agreement.

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**ARTICLE VII**

**Warranties andIndemnification**

Section*   7.1.   Warranties.  *PLCwarrants that (a) it possesses good and marketable title to all Laser Power Sources sold to Edwards underthis Agreement upon delivery to Edwards of such Laser Power Sources; and (b) atthe time of delivery, each Laser Power Source will conform to itsspecifications and will operate according to the indications described in itslabeling; and (c) it complies and will continue to comply with allapplicable laws and regulations of the United States and the countries of theEuropean Union with respect to Model 3 Laser Power Sources. Edwards warrantsthat it complies and will continue to comply with all applicable laws andregulations of the Territory with respect to Laser Power Sources and the salethereof.

(a)   EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENTOR IN ANY OF THE TRANSACTION DOCUMENTS, PLC AND ITS THIRD PARTY LICENSORS ANDSUPPLIERS EXPRESSLY DISCLAIM ALL OTHER WARRANTIES, REPRESENTATIONS, CONDITIONS,GUARANTEES OR UNDERTAKINGS OF ANY KIND, EXPRESS OR IMPLIED, STATUTORY OROTHERWISE INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULARPURPOSE.

(b)   EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENTOR IN ANY OF THE TRANSACTION DOCUMENTS, EDWARDS AND ITS THIRD PARTY LICENSORS ANDSUPPLIERS EXPRESSLY DISCLAIM ALL OTHER WARRANTIES, REPRESENTATIONS, CONDITIONS,GUARANTEES OR UNDERTAKINGS OF ANY KIND, EXPRESS OR IMPLIED, STATUTORY OROTHERWISE INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULARPURPOSE.

Section 7.2.*  **Indemnification by PLC.*  **PLC and PLCParent shall indemnify and hold harmless Edwards, its officers, directors,shareholders, employees, parents, successors, Affiliates, assigns, in eachcase, from and against any and all costs or expenses (including, withoutlimitation, reasonable attorneys’ fees, and the reasonable out-of-pocketexpenses of testifying and preparing for testimony and responding to documentand other information requests, whether or not a party to such litigation),judgments, fines, losses, claims (whether or not meritorious) and damages(collectively, “Damages”), as incurred, to the extent they relate to, arise outof or are the result of (i) the manufacture by PLC of any Laser PowerSources (except to the extent attributable to components supplied by Edwards); (ii) thedesign of any Laser Power Sources or component of Laser Power Sources notdeveloped exclusively by Edwards except to the extent designed and 

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built inaccordance with the specifications provided by Edwards or attributable to thecomponents supplied by Edwards; (iii) the failure of Laser Power Sourcesto satisfy any warranty made by PLC; (iv) PLC failing to perform any ofits covenants and responsibilities under this Agreement or any breach by PLC ofany representation or warranty; and (v)  PLC’s gross negligence,willful misconduct or fraud in the development, labeling, supply andmanufacture of Laser Power Sources by PLC.

Section 7.3.*  **Indemnification by Edwards.*  **Edwards shallindemnify and hold harmless PLC, its officers, directors,shareholders, employees, parents, successors, Affiliates and assigns, in eachcase, from and against any and all Damages, as incurred, to the extent theyrelate to, arise out of or are the result of (i) the specifications of theLaser Power Sources provided by Edwards; (ii) the sale by Edwards of anyLaser Power Sources or any other product or service not provided by PLChereunder except to the extent Edwards is indemnified by PLC; (iii) Edwardsfailing to perform any of its covenants and responsibilities under thisAgreement or any breach by Edwards of any representation or warranty; and (iv) Edwards’gross negligence, willful misconduct or fraud in the promotion and sale ofLaser Power Sources or other product or service by Edwards.

Section 7.4.*  **Indemnification Procedures.*  **The Partyseeking indemnification (the “Indemnified Party”) pursuantto this Article VII shall promptly notify the indemnifying party (the “IndemnifyingParty”), in writing, of such claim describing such claim in reasonable detail, *provided* that the failure to provide suchnotice shall not affect the obligations of the Indemnifying Party unless andonly to the extent it is actually prejudiced thereby. In the event that suchclaim involves a claim by a third party against an Indemnified Party, theIndemnifying Party shall have 30 days after receipt of such notice to decidewhether it will undertake, conduct and control, through counsel of its ownchoosing (but reasonably acceptable to the Indemnified Party) and at its ownexpense, the settlement or defense thereof unless (i) the IndemnifyingParty is also a party to the proceeding and the Indemnified Party determines ingood faith that joint representation would be inappropriate or (ii) theIndemnifying Party fails to provide reasonable assurance to the IndemnifiedParty of its financial capacity to defend such proceeding, and provideindemnification with respect thereto, and if it so decides, the IndemnifiedParty shall cooperate with it in connection therewith, *provided* that the Indemnified Party mayparticipate in such settlement or defense through counsel chosen by it, and *provided further* that the fees andexpenses of such counsel shall be borne by the Indemnified Party. TheIndemnifying Party shall not, without the written consent of the IndemnifiedParty (which consent shall not be unreasonably withheld, conditioned ordelayed), settle or compromise any action, unless such settlement or compromiseincludes an unconditional release of the Indemnified Party. If the IndemnifyingParty does not notify the Indemnified Party within 30 days after the receipt ofnotice of a claim of indemnity hereunder that it elects to undertake thedefense thereof, the Indemnified 

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Party shall havethe right to contest, settle or compromise the claim but shall not pay orsettle any such claim without the consent of the Indemnifying Party (whichconsent shall not be unreasonably withheld, conditioned or delayed). TheIndemnifying Party and the Indemnified Party shall cooperate fully in allaspects of any investigation, defense, pre-trial activities, trial, compromise,settlement or discharge of any claim in respect of which indemnity is soughtpursuant to Article VII, including, but not limited to, providing theother Party with reasonable access to employees and officers (including aswitnesses) and other information. The remedies provided in this Article VIIwill not be exclusive of or limit any other remedies that may be available tothe Indemnified Parties.

Section 7.5.*  **Limitations on Liability.*  **NOTWITHSTANDINGANYTHING TO THE CONTRARY IN THISAGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR THE OTHER PARTY’SAFFILIATES FOR ANY INCIDENTAL, PUNITIVE, SPECIAL, MULTIPLE OR INDIRECT ORCONSEQUENTIAL DAMAGES, HOWEVER CHARACTERIZED, INCLUDING, WITHOUT LIMITATION,LOSS OF PROFITS OR BUSINESS OPPORTUNITIES, ARISING OUT OF, RELATED TO, OR INCONNECTION WITH THIS AGREEMENT OR ITS EARLY TERMINATION. IRRESPECTIVE OFWHETHER SUCH LIABILITY IS ASSERTED IN TORT OR CONTRACT AND IRRESPECTIVE OFWHETHER THE PARTIES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ALLREMEDIES OF THE PARTIES SHALL BE LIMITED TO ACTUAL DIRECT DAMAGES.

**ARTICLE VIII**

**Trademarks andConfidentiality; Intellectual Property Rights**

Section 8.1.*  **Trademarks.*  **Subject to PLC’s consent, which consentshall not be unreasonably, withheld, delayedor conditioned, Edwards shall have the right to indicate to the public that itis an authorized distributor of Laser Power Sources and, at Edwards’ election, tomarket and sell Laser Power Sources under any trademarks, service marks andtrade names that PLC adopts from time to time. Edwards shall state and confirmin all advertising and promotional literature that its use of PLC’s trademarks,service marks and trade names is pursuant to a license from PLC and shallidentify PLC as the owner of such marks and names and any proprietary rights. Edwardsshall not alter, obscure or remove any trademarks, service marks or trade namesof PLC which are contained on or in or affixed to Laser Power Sources at thetime of shipment. Edwards shall not use any trademarks, service marks or tradenames of PLC in connection with any business conducted by Edwards other thandealing with Laser Power Sources in accordance with the terms of this Agreement.Edwards agrees that its use of the trademarks, service marks and 

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trade names of PLCshall not create in its favor any right, title or interest therein andacknowledges PLC’s exclusive right, title and interest thereto. Edwards agreesthat it will not use, without PLC’s prior written consent, any mark which issimilar to or is likely to be confused with any trademarks, service marks ortrade names of PLC. In order to comply with PLC’s quality control standards,Edwards shall:  (i) not modify anyof PLC’s trademarks, service marks or trade names in any way; (ii) use PLC’strademarks, service marks or trade names in compliance with all applicable lawsand regulations; and (iii) upon 30 days written notice, accord PLC theright to inspect during normal business hours, Edwards’ or its Affiliatesfacilities used in connection with efforts to promote and sell the Laser PowerSources in order to confirm that Edwards’ use of any of PLC’s trademarks,service marks or trade names is in compliance with this Section 8.1. Edwards’rights to use the trademarks, service marks and trade names of PLC as set forthin this Section 8.1 shall terminate upon termination or expiration of thisAgreement.

Section 8.2.*  **Confidential Information*.*  *In order to avoiddisclosure of confidential and proprietary information to any other person, firmor corporation, the Parties agree that each will treat any such informationwhich is received from one another in writing and clearly marked as “Confidential”or if disclosed orally, which is confirmed in writing as “Confidential” withinthirty (30) days of initial disclosure, with the same degree of care that eachemploys with respect to its own information which it does not desire to havepublished or disseminated. It is understood that each Party shall be liable forany unauthorized disclosure should it fail to safeguard the disclosedinformation with such care. This obligation shall survive the termination orexpiration of this Agreement. The Parties shall not have any obligation withrespect to such information which is:

(a)   independently developed by the receivingParty without the benefit of the disclosure or is already known to thereceiving Party at the time of the disclosure;

(b)   publicly known or becomes publicly knownwithout the wrongful act or breach of this Agreement by the receiving Party;

(c)   rightfully received by the receiving Partyfrom a third-party who is not under any obligation of confidentiality or tradesecret obligation to the originating Party;

(d)    is already known to the receiving Party atthe time of the disclosure; or

(e)   is disclosed by the receiving Party with thewritten approval of the originating Party.

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**ARTICLEIX**

**MISCELLANEOUS**

Section 9.1.*  **Relationship*.*  *The relationship ofEdwards and PLC established by this Agreement is of independent contractors and notagents (except as set forth in Section 2.1), and nothing in this Agreementshall be construed:

(a)   To give PLC or PLC Parent the power to director control the daily activities of Edwards, or vice versa, beyond theobligations imposed on Edwards and PLC, respectively, by this Agreement;

(b)   To constitute the Parties as partners, jointventurers, co-owners or otherwise as participants in joint undertaking; or

(c)   To allow either PLC or PLC Parent to createor assume any obligation on behalf of Edwards, or vice versa, for any purposewhatsoever. The purchase, promotion, and resale of, or any other legaltransactions concerning Laser Power Sources hereunder shall be carried out inthe name of and for the account of Edwards as principal, and Edwards shall notenter into any agreement with third persons binding in any way on PLC or PLCParent.

Section 9.2.*  **No Conflict*.*  *Each Party represents andwarrants to the other Parties that it is not subject to any contractual obligation orrestraint which will materially interfere with its right and ability to performpursuant to the terms of this Agreement.

Section 9.3.*  **Governing Law*.*  *This Agreement shall begoverned by, interpreted under, and construed in accordance with the internal laws ofthe State of New York, including, without limitation, Sections 5-1401,5-1402 of the New York General Obligations Law and New York CivilPractice Laws and Rules 327(b).

Section 9.4.*  **Escalation*.*  *Edwards and PLC (and/orPLC Parent) will attempt in good faith to resolve expeditiously any dispute, claim orcontroversy arising out of or relating to this Agreement (the “Dispute”)promptly by negotiations between executives who have authority to settle thecontroversy and who are at a higher level of management than the persons withdirect responsibility for the administration of this Agreement. Either Partymay give the other Party, written notice (the “Escalation Notice”) of anyDispute not resolved in the normal course of business. Within 15 days afterdelivery of the Escalation Notice, the Party in receipt of the EscalationNotice shall submit to the other a written response. The Escalation 

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Notice and theresponse thereto shall include (a) a statement of each Party’s positionand a summary of arguments supporting that position, and (b) the name andtitle of the executive who will represent that Party and of any other personwho will accompany the executive. Within 30 days after delivery of theEscalation Notice, the executives of both Parties shall meet at a mutuallyacceptable time and place, and thereafter as often as they reasonably deemnecessary, to attempt to resolve the Dispute. All reasonable requests forinformation made by one Party to the other will be honored. All negotiationspursuant to this clause are confidential and shall be treated as compromise andsettlement negotiations for purposes of applicable rules of evidence. TheParties shall attempt to resolve any Dispute pursuant to the procedure setforth in this Section 9.4 for a period up to 60 days from the date ofdelivery of the Escalation Notice before resorting to other available remedies;*provided, however*, nothingcontained in this Section 9.4 shall prevent any Party from resorting tojudicial process if injunctive or other equitable relief from a court isnecessary to prevent serious and irreparable injury to it or to others. The useof the procedure set forth in this Section 9.4 will not be construed underthe doctrine of laches, waiver or estoppel to affect adversely any Party’sright to assert any claim or defense.

Section 9.5.*  **Jurisdiction and Consent to Service*.*  *Inaccordance with the laws of the State of New York, andwithout limiting the jurisdiction or venue of any other court, the Parties (a) agreethat any suit, action or proceeding arising out of or relating to this Agreementshall be brought solely in the state or federal courts of New York; (b) consentto the exclusive jurisdiction of each such court in any suit, action orproceeding relating to or arising out of this Agreement; (c) waive anyobjection which any of them may have to the laying of venue in any such suit,action or proceeding in any such court; and (d) agree that service of anycourt paper in any such suit, action or proceeding may be made in any manner asmay be provided under the applicable laws or court rules governing serviceof process in such court. The foregoing shall not apply to actions forinjunctive relief, as to which such jurisdiction shall be non-exclusive.

Section 9.6.*  **Notices*.*  *All notices, demands, requests, consents, approvalsor other communications required or permittedto be given hereunder or which are given with respect to this Agreement shallbe in writing and shall be delivered (charges prepaid, receipt confirmed orreturn receipt requested (if available)) by hand, by nationally recognized aircourier service, by certified mail or facsimile, addressed as set forth belowor to such other address as such Party shall have specified most recently bywritten notice. Notice shall be deemed given and effective (i) ifdelivered by hand or by nationally recognized courier service, when deliveredat the address specified in this Section 9.6 (or in accordance with thelatest unrevoked written direction from such Party), (ii) if by certifiedmail, four (4) business days after mailing or (iii) if given byfacsimile when such facsimile is transmitted to the fax number specified inthis Section 9.6 (or in accordance with the 

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latest unrevokedwritten direction from such Party), provided the appropriate confirmation isreceived.

To PLC:

PLC Systems Inc.10 Forge ParkFranklin, MA  02038Attention:  Chief Executive OfficerFax:  (508) 541-7990

with a copy (which shallnot constitute notice) to:

Wilmer Cutler PickeringHale and Dorr LLP60 State StreetBoston, MA  02109Attention:  Jeffrey A. Stein, Esq.Fax:  (617) 526-5000

To Edwards:

Edwards Lifesciences LLCOne Edwards WayIrvine, California 92614Attention:  General CounselFax:  (949) 250-6850

with a copy (which shallnot constitute notice) to:

Skadden, Arps, Slate,Meagher & Flom LLP300 South Grand Avenue, Suite 3400Los Angeles, California  90071-3144Attention:  Joseph J. Giunta, Esq.Fax:  (213) 687-5600

Section 9.7.*  **Interpretation*.*  *When a reference is madein this Agreement to a Section, Schedule or Exhibit, such reference shall be toa Section, Schedule or Exhibit of this Agreement unless otherwiseindicated. When a reference is made in this Agreement to a specific Schedule,such reference shall be deemed to include, to the extent applicable, all theother Schedules. The table of contents, table of definitions, titles andheadings contained in this Agreement are for reference purposes only and shallnot affect in any way the meaning or interpretation of this Agreement. When thewords “includes” or “including” are used in this Agreement, they shall bedeemed to be followed by the words “without limitation.”  All 

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accounting termsnot defined in this Agreement shall have the meanings determined by generallyaccepted accounting principles as of the date hereof. All capitalized termsdefined herein are equally applicable to both the singular and plural forms ofsuch terms.

Section 9.8.*  **Severability*.*  *In the event that any oneor more of the provisions contained herein, or the application thereof in anycircumstances, is held invalid, illegal or unenforceable in any respect for anyreason, the Parties shall negotiate in good faith with a view to thesubstitution therefore of a suitable and equitable solution in order to carryout, so far as may be valid and enforceable, the intent and purpose of suchinvalid provision; provided, however,that the validity, legality and enforceability of any such provision in everyother respect and of the remaining provisions contained herein shall not be inany way impaired thereby, it being intended that all of the rights andprivileges of the Parties hereto shall be enforceable to the fullest extent permittedby law.

Section 9.9.*  **Counterparts*.*  *This Agreement may beexecuted in two or more counterparts, each of which shall be deemed an original and allof which shall, taken together, be considered one and the same agreement, itbeing understood that the Parties need not sign the same counterpart.

Section 9.10.*  **Entire Agreement; No Third Party Beneficiaries*.*  *ThisAgreement, including all schedules and exhibits hereto, by andamong the Parties hereto,

(a)   constitute the entire agreement of theParties with respect to the subject matter hereof and supersede all prior andcontemporaneous agreements, representations, understandings, negotiations anddiscussions between the Parties, whether oral or written, with respect to thesubject matter hereof, other than the Termination Letter; and

(b)   shall be binding upon and shall inure to thebenefit of each of the Parties hereto and thereto and their respectivesuccessors and permitted assigns and is not intended to confer any rights,remedies or benefits on any Persons other than as expressly set forth in this Section 9.10.

*Section 9.11.*  **Amendments andModifications; Waivers and Extensions.

(a)   No amendment, modification or termination ofthis Agreement shall be binding upon any other Party unless executed in writingby the Parties hereto intending to be bound thereby.

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(b)   Any Party to this Agreement may waive anyright, breach or default which such Party has the right to waive; provided thatsuch waiver will not be effective against the waiving Party unless it is in writing,is signed by such Party, and specifically refers to this Agreement. Waivers maybe made in advance or after the right waived has arisen or the breach ordefault waived has occurred. Any waiver may be conditional. No waiver of anybreach of any agreement or provision herein contained shall be deemed a waiverof any preceding or succeeding breach thereof nor of any other agreement orprovision herein contained. No failure or delay in exercising any right, poweror privilege hereunder shall be deemed a waiver or extension of the time forperformance of any other obligations or acts nor shall any single or partialexercise thereof preclude any other or further exercise thereof or the exerciseof any other right, power or privilege.

Section 9.12.*  **Assignment*.*  *Neither this Agreement norany of the rights, duties or obligations hereunder may be assigned or delegated by anyof the Parties hereto without the prior written consent of PLC or Edwards, asthe case may be, which may be withheld in its sole discretion except thatEdwards may assign all its rights and obligations to any direct or indirectwholly-owned or consolidated subsidiary of Edwards Lifesciences Corporation,provided, however, any Party may assign this Agreement and all rights, duties orobligations hereunder in connection with the sale of more than 51% of theoutstanding capital stock of such Party in one or more related transactions, amerger or the transfer of all or substantially all the assets to which thisAgreement relates. Any attempted assignment or delegation of rights, duties orobligations hereunder in contravention hereof shall be void and of no effect.

Section 9.13.*  **Schedules*.*  *Each of the schedulesreferred to herein and attached hereto is an integral part of this Agreement and is incorporatedherein by reference.

Section 9.14.*  **Expenses*.*  *Except as otherwiseprovided in this Agreement, each Party to this Agreement shall bear its respective expenses incurred inconnection with the preparation, execution, and performance of this Agreementand the transactions contemplated hereby, including all fees and expenses ofagents, representations, counsel and accountants.

Section 9.15.*  **No Consequential or Punitive Damages*.*  *Ifany Party claims any breach of this Agreement bythe other Party or otherwise becomes dissatisfied with any matter relatinghereto or arising herefrom, it shall have no right to seek consequential orpunitive damages and each Party hereby waives any right it may have to seeksuch punitive or consequential damages.

24

----

Section 9.16.*  **Force Majeure*.*  *Notwithstanding anythingto the contrary contained in this Agreement, no liability or loss of rightshereunder shall result to any Party from delay or failure in performance (otherthan payment) caused by governmental restrictions (excluding any regulatoryactions taken by the FDA or similar bodies), war, acts of terrorism,commotions, riots, strikes, lockouts and acts of God such as fire, flood orother similar causes that are beyond the control of the parties (each a “ForceMajeure Event”). Except to the extent caused by the foregoing, Force MajeureEvents shall not include shortage of labor, lack of or inability to obtainmaterials, fuel or supplies (unless caused solely by priorities, restrictionsor allocations imposed by governmental authority), or any other industrialdisturbance.

25

----

IN WITNESS WHEREOF, the Parties hereto have executedthis Agreement as of the date first above written.
|   | PLC SYSTEMS INC.          |
|--------|---------------------------|
|   |                      |
|   | By:                       | /s/ James G. Thomasch |
|   | Name:                     | James G. Thomasch |
|   | Title:                    | Senior Vice President and Chief Financial Officer |
|   |                      |   |
|   |                      |   |
|   | PLC MEDICAL SYSTEMS, INC. |
|   |                      |
|   | By:                       | /s/ James G. Thomasch |
|   | Name:                     | James G. Thomasch |
|   | Title:                    | Senior Vice President and Chief Financial Officer |
|   |                      |   |
|   |                      |   |
|   | EDWARDS LIFESCIENCES LLC  |
|   |                      |
|   | By:                       | /s/ John H. Kehl, Jr. |
|   | Name:                     | John H. Kehl, Jr. |
|   | Title:                    | Corporate Vice President, Strategy and Business  Development |

 

----

**Exhibit A**

**Laser3 Power****Source Specifications**

**Optiwave980TM Laser Console**

**System Requirements**

(based upon Minnetronix # DP-0001-45-1 Rev 002-a)
| **Mike Adams**                       | ** ** | ***/s/ Michael Adams***                  | ** ** | **6/3/05** |
|--------------------------------------|------------|------------------------------------------|------------|------------|
| New Ventures (Print)                 |       | New Ventures (Signature)                 |       | Date       |
|                                 |       |                                     |       |       |
| **Ken Luppi**                        | ** ** | ***/s/ Ken Luppi***                      | ** ** | **6/3/05** |
| Operations (Print)                   |       | Operations (Signature)                   |       | Date       |
|                                 |       |                                     |       |       |
| **Debbie Quigley**                   | ** ** | ***/s/ Debbie Quigley***                 | ** ** | **6/7/05** |
| Clinical (Print)                     |       | Clinical (Signature)                     |       | Date       |
|                                 |       |                                     |       |       |
| **Dori Boermeester**                 | ** ** | ***/s/ Dori Boermeester***               | ** ** | **6/6/05** |
| Quality Assurance/Regulatory (Print) |       | Quality Assurance/Regulatory (Signature) |       | Date       |
|                                 |       |                                     |       |       |
| **Mark Tauscher**                    | ** ** | ***/s/ Mark Tauscher***                  | ** ** | **6/7/05** |
| Marketing/Sales (Print)              |       | Marketing/Sales (Signature)              |       | Date       |

 

----

 

## ***1 Introduction                                                                                                                   ****Section Heading                                  Version: 1.4              (SYSREQ35557)*

## ***1.1  Scope                                                                                                                      ****Section Heading                                  Version:5.0              (SYSREQ35558)*

This specification describes the functional andperformance requirements of the Optiwave 980TM Laser Console (console). Theconsole is intended for use with a fiber delivery device to deliver 980 nmlaser energy for surgical treatment. This document comprises the full set ofrequirements for the console and is intended for internal use only, for reviewand reference by development and product support teams.

This document contains both system requirements anddevelopment guidelines. System requirements are denoted as such in sectionheadings and will be tested against during verification testing. Development guidelinesin this document include all sections denoted as guidelines, references,targets, or overviews and will not specifically be addressed by systemverification testing.

## ***1.2 Glossary                                                                                                                 ****Background Info                                  Version:10.0              (SYSREQ35562)*

**Delivery Device**:[**]

**Laser Console**(console):[**]

**Laser System**(system): [**]

**Wavelength**:[**]

**Laser product**:[**]

**Low OH**: [**]

**Numerical Aperture**(NA): [**]

**UI**: [**].

**Thermal Safety System**(TSS): [**].

**Optical Path**:[**]

**Endocardial**:  [**]

**Epicardial**:  [**]

**Surgical**:  [**]

**Optic Block** and **Optic Module** both refer to [**].

## ***2 System Overview                                                                                                            ****Section Heading                                  Version:1.4              (SYSREQ35563)*

***2.1  General Description                                                                                            ****Background Info                                  Version:6.0              (SYSREQ35564)*

The console is intended for surgical treatment usingphotonic energy to form lesions at locations in the cardiac anatomy that mayprovide effective and appropriate conduction block. The system includes [**]

----

***2.2  Basic System Configuration                                                                              ***

*Section Heading                                  Version:1.5              (SYSREQ35565)*

***2.2.1  Block Diagram                                                                                            ***

*BackgroundInfo                             Version:2.3              (SYSREQ35566)*

The diagram identifies [**]:

[**]

***2.2.2  System Components                                                                                    ***

*BackgroundInfo                           Version: 10.0              (**SYSREQ35567)*

The console includes the following basic functionalblock or components:

[**]

***2.3  Useful Life                                                                                                             ****Design Guideline                                Version:2.2               (SYSREQ35568)*

The console’s useful life shall exceed [**]

## ***3  System Requirements                                                                                                    ***

*Section Heading                                      Version: 3.3               (SYSREQ35569**)***

This section includes the functional and performancerequirements for the console, i.e. what functions the system must perform andto what accuracy and/or precision those functions *must*be performed.

 

***3.1  General Tolerances                                                                                             ***

*Traceable Requirement                    Version: 1.3              (SYSREQ36453)*

Unless otherwise specified, the default tolerance forspecifications is [**]

Thisrequirement traces TO SUBTST36070: General Instructions

***3.2  Laser Energy Generation                                                                                   ***

*Section Heading                                Version:1.5                 (SYSREQ35570)*

***3.2.1  Therapy Duration                                                                                       ***

*TraceableRequirement                Version:2.2                 (**SYSREQ35571)*

The console shall monitor therapy duration [**]

This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer

Thisrequirement traces TO SUBREQ35810:  UICCountdown Therapy Timer

----

 

***3.2.2  Output Power Monitor                                                                                               ***

*TraceableRequirement                                 Version: 6.4              (**SYSREQ35572)*

The console shall include means for directly orindirectly monitoring output laser power from the console. Accuracy of thepower monitoring shall be [**].

Thisrequirement traces TO SUBTST36152:  TestProtocol 002 - Laser Power Regulation

***3.2.3  Output Port                                                                                                                   ***

*TraceableRequirement                                 Version: 2.2              (**SYSREQ35573)*

The laser output from the console shall be compatiblewith a standard SMA 905 optical connector.

Thisrequirement traces TO SUBREQ35993:  LaserOutput Port

***3.2.4  Output Port NA                                                                                                            ***

*TraceableRequirement                                 Version: 1.8              (**SYSREQ35574)*

The output NA of the laser output port into thedelivery fiber must be [**].

Thisrequirement traces TO SUBREQ35926: Output Port NA

***3.2.5  Output Spot Size                                                                                                          ***

*DesignGuideline                                 Version: 1.4                      (**SYSREQ35575)*

The theoretical/calculated output spot size of thelaser output port into the delivery fiber must be [**].

The calculation used is:  [**].

***3.2.6  Continuous Use                                                                                                           ***

*TraceableRequirement                          Version: 4.2                    (**SYSREQ35576)*

The console shall be capable of operating at fulllaser output power continuously for the following duty cycles. These dutycycles represent one procedure.

[**]

[**]

Thisrequirement traces TO SUBTST36157:  TestProtocol 006 - Continuous Use

----

 

***3.2.7  **LASER SHUTOFF**                                                                                            ***

*Traceable Requirement                                  Version:2.0              (**SYSREQ35577**)***

When the laser is shutoff due to a normal or abnormalevent, laser output must be reduced to [**].

Note: A Laser Shutoff event moves the laser from aREADY or ACTIVE state to a STANDBY state.

This requirement traces FROM SYSREQ35622:  Device Response: Alarm

This requirement traces FROM SYSREQ35619:  Device Response: Alert

This requirement traces FROM SYSREQ35620:  System Alarms

This requirement traces FROM SYSREQ35616:  System Alerts

Thisrequirement traces TO SUBREQ35922:  LaserShutoff

***3.2.8  Max Power Formula                                                                                                  ***

*DesignGuideline                                 Version: 3.2              (**SYSREQ35578)*

The following formula should be used to determine ifthe total power the user has requested exceeds the console capability. MaxPower is defined as the power delivered out the front of the optical block.

Max DeliveredPower = [**]

Max Power = [**]

***3.2.9  Redundant Power Monitoring                                                                                 ***

*Critical Requirement                                  Version:2.2              (SYSREQ35579)*

The console shall monitor the laser output both [**].

Thisrequirement traces TO SUBREQ35916: Closed-Loop Laser Output Control

***3.3  Safety Interlocks                                                                                                                  ***

*Section Heading                                             Version: 1.5                  (SYSREQ35580)*

***3.3.1  Output Port Interlock                                                                                                 ***

*Critical Requirement                                  Version:3.2                (SYSREQ35581)*

The console shall require that an output fiber beinserted into the console’s laser output connector [**].

Note: The Output Port Interlock is also known as theDevice Interlock.

This requirement traces TO SUBREQ35983:  Laser Enable Inputs

Thisrequirement traces TO SUBREQ35981: Output Port Interlocks

----

##  

***3.3.2  Remote Interlock                                                                                                        ***

*Traceable Requirement                                  Version:3.2              (SYSREQ35582)*

The console shall include a remote interlock input andthe system shall require that the remote interlock be [**].

Note: The Remote Interlock is also known as the DoorInterlock.

This requirement traces TO SUBREQ35983:  Laser Enable Inputs

Thisrequirement traces TO SUBREQ35980: Remote Interlock

***3.3.3  Housing Interlock                                                                                                       ***

*Critical Requirement                                  Version:3.2              (SYSREQ35583)*

The console shall require that the console housinginterlock be closed [**]

Thisrequirement traces TO SUBREQ35979: Housing Interlocks

***3.4  IR Monitoring and Shut-off                                                                                              ***

*Critical Requirement                                  Version:8.0              (SYSREQ35584)*

The console shall monitor [**]

This requirement traces TO SUBREQ35927:  IR Detector

This requirement traces TO SUBREQ35840:  Abort: Thermal Safety System Tripped

Thisrequirement traces TO SUBREQ35983:  LaserEnable Inputs

***3.4.1  Thermal Safety System                                                                                               ***

*Critical Requirement                                  Version: 3.1              (SYSREQ35585)*

The console shall perform a [**]

This requirement traces FROM SUBFMA36069:  User performs Therapy into Dustcap

Thisrequirement traces TO SUBREQ35740: Thermal Safety System BIT

***3.4.2  Sampling Period                                                                                                         ***

*Traceable Requirement                                  Version:2.1              (SYSREQ35586)*

The console shall sample [**]

Thisrequirement traces TO SUBTST36183:  Unitand Integration Tests

***3.4.3  Output Port Shield                                                                                                      ***

*Traceable Requirement                                  Version:6.0              (SYSREQ35587)*

There will be an output port shield [**]

Note: The Output Port Shield is also known as aDustcap.

This requirement traces TO SUBREQ36004:  Laser Output Port Shield

This requirement traces TO SUBREQ35740:  Thermal Safety System BIT

----

##  

***3.4.4  Delivery Device Replacement                                                                                   ***

*Traceable Requirement                                  Version:5.0              (SYSREQ35588)*

The console shall require the user to replace thedelivery device [**]

[**]

This requirement traces FROM SUBFMA36069:  User performs Therapy into Dustcap

Thisrequirement traces TO SUBREQ35840: Abort: Thermal Safety System Tripped

***3.5  User Interface                                                                                                                       ***

*Section Heading                                  Version:1.6              (SYSREQ35589)*

 

Thisrequirement traces TO SYSREQ36986:  LaserState Transitions

***3.5.1  Laser State Transitions                                                                                              ***

*BackgroundInfo                                 Version: 1.3             (SYSREQ36986)*

The following diagram describes the laser statetransition.

Thisrequirement traces FROM SYSREQ35589:  hUser Interface

***3.5.2  User Inputs                                                                                                                   ***

*Section Heading                                  Version:1.6              (SYSREQ35590*

 

***3.5.2.1  Input Checking                                                                                                   ***

*CriticalRequirement                                 Version: 3.2              (*SYSREQ35591*)*

All user inputs will be checked for validity. The userwill not be allowed to proceed in the UI until invalid inputs are corrected.

This requirement traces TO SUBREQ35774:  Delivery Device Number Entry

This requirement traces TO SUBREQ35773:  Number Entry

Thisrequirement traces TO SUBREQ35771:  PickFrom List

***3.5.2.2 ******Delivery DeviceNumber                                                                                   ***

*Section **Heading                                  Version:4.0              (SYSREQ35592**)***

This section describes the behavior of the Device Number.This number will be included with every completed delivery device.

***3.5.2.2.1  Delivery Device Number Required                                                         ***

*Critical Requirement                       Version: 4.0                   (SYSREQ35593)*

The UI shall require thatthe user enter in the Delivery Device Number before *applying*therapy.

 

This requirement traces TO SUBREQ35774:  Delivery Device Number Entry

Thisrequirement traces TO SUBREQ35791: Required Fields

----

##  

***3.5.2.2.2  Delivery Device Number Format                                                                            ***

*Traceable Requirement                                  Version:6.0              (SYSREQ35594)*

The Delivery DeviceNumber has the following format. The dashes are included to as an aid inremembering the number for ease of entry.

[**]

This requirement traces TO SUBREQ35795:  Checksum Algorithm

This requirement traces TO SUBREQ35793:  Delivery Device Number Format

Thisrequirement traces TO SUBREQ35794: Encyption Algorithm

***3.5.2.2.3  Delivery Device Number History                                                                            ***

*Traceable**Requirement                                  Version:3.0              (SYSREQ35595)*

The console shall keeptrack of the last [**]

 

Thisrequirement traces TO SUBREQ35796: Delivery Device Number Log

***3.5.2.2.4 ******Prevent Reuse                                                                                                             ***

*Traceable**Requirement                                 Version:2.2              (SYSREQ35596)*

A device number can bereused in any of following cases. In all other cases, the number cannot bereused.

·                  [**]

Thisrequirement traces TO SUBREQ35797: Delivery Device Number Reuse

***3.5.2.2.5 ******Invalid DeliveryDevice Number                                                                            ***

*Traceable**Requirement                                  Version:3.0              (SYSREQ35597)*

If the user enters aninvalid Delivery Device Number, a message is displayed, and the Device numberfield cleared.

 

Thisrequirement traces TO SUBREQ35798: Invalid Delivery Device Number Entry

***3.5.2.3 ******Therapy Power                                                                                                                    ***

*Traceable**Requirement                                  Version:2.2              (SYSREQ35598)*

The console shall providemeans for the user to enter therapy power.

 

Thisrequirement traces TO SUBREQ35787: Parameters Displayed

***3.5.2.4 ******Therapy Duration                                                                                                               ***

*TraceableRequirement                                 Version: 2.4             (SYSREQ35599)*

The console shall providemeans for the user to enter maximum therapy duration with a resolution of [**].

 

Thisrequirement traces TO SUBREQ35787: Parameters Displayed

----

 

***3.5.2.4.1 ******Therapy TimerIncrements                                                                                      ***

*Traceable**Requirement                                  Version:1.7              (SYSREQ35600)*

Therapy duration timewill count down in [**] intervals whenever the system’s [**].

 

This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer

Thisrequirement traces TO SUBREQ35810:  UICCountdown Therapy Timer

***3.5.2.4.2 ******Reset at TherapyCompletion                                                                                 ***

*Traceable**Requirement                                  Version:1.5              (SYSREQ35601)*

Therapy duration timewill be reset to the initial desired therapy time at the completion of therapy.

 

Thisrequirement traces TO SUBREQ35799:  SetupScreen Reentry

***3.5.2.4.3  Pre-******therapy TemperatureCheck                                                                            ***

*Traceable**Requirement                                  Version:3.1              (SYSREQ35602)*

While on the Therapyscreen, prior to switching to READY mode, the software shall monitor thetemperature of the diodes. [**]

 

While waiting for thecurrent temperature to go down, the user can hit a softkey to go back to theSetup screen.

 

Thisrequirement traces TO SUBREQ36460:  DiodeTemp Check Prior to Therapy

***3.5.2.5 ******Therapy Operation                                                                                                             ***

*Section **Heading                                  Version:4.0              (SYSREQ35603)*

The following termsdefine the operational states of the console:

 
| · | ** ** | **OFF:**     |   | console is not supplied with AC power, all displays  are blank and the laser is de-energized.                                         |
|--------|------------|--------------|--------|---------------------------------------------------------------------------------------------------------------------------------------|
| · | ** ** | **STANDBY:** |   | console is powered-on,  laser is de-energized. Laser can not enter the ACTIVE state (energize the  laser) by pressing the footswitch. |
| · | ** ** | **READY:**   |   | console is powered-on,  laser is de-energized. User can enter the ACTIVE state via footswitch  activation.                            |
| · | ** ** | **ACTIVE:**  |   | console is powered-on,  footswitch is activated and the laser is energized.                                                           |

 

----

 

***3.5.2.5.1  Start of Therapy                                                                                                         ***

*Critical**Requirement                                  Version:10.1              (SYSREQ35604)*

The following must haveoccurred before therapy can start:

 

[**]

This requirement traces TO SUBREQ36418:  Delivery Device Irrigation Check Screen

This requirement traces TO SUBREQ35807:  Footswitch Open before READY

This requirement traces TO SUBREQ35983:  Laser Enable Inputs

This requirement traces TO SUBREQ36549:  Output Port Shield Still Attached

This requirement traces TO SUBREQ35787:  Parameters Displayed

This requirement traces TO SUBREQ35809:  Instruction Displayed

This requirement traces TO SUBREQ35975:  Keyed Power Switch

Thisrequirement traces TO SUBREQ35791: Required Fields

***3.5.2.5.2 ******Therapy Pause                                                                                                            ***

*Traceable**Requirement                                  Version:1.9              (SYSREQ35605)*

Therapy shall be paused[**]  While therapy is paused, [**]

 

This requirement traces TO SUBREQ35812:  Cessation of Therapy

This requirement traces TO SUBREQ35822:  5 sec visible countdown

This requirement traces TO SUBREQ35821:  5 Second Maximum Pause Time

This requirement traces TO SUBREQ35824:  Displayed Information

Thisrequirement traces TO SUBREQ35823: Softkeys: Therapy Paused Screen

***3.5.2.5.3 ******Therapy Complete                                                                                                     ***

*Traceable**Requirement                                  Version:1.5              (SYSREQ35606)*

Therapy shall be completeand the laser de-energized when remaining therapy duration time is [**]seconds.

 

This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer

This requirement traces TO SUBREQ35812:  Cessation of Therapy

Thisrequirement traces TO SUBREQ35810:  UICCountdown Therapy Timer

***3.5.2.5.4 ******Therapy Abort                                                                                                            ***

*Traceable**Requirement                                  Version:8.3              (SYSREQ35607)*

Therapy shall beconsidered aborted and the laser de-energized in response to any of thefollowing conditions.

 

[**]

This requirement traces FROM SYSREQ35619:  Device Response: Alert

This requirement traces TO SUBREQ35821:  5 Second Maximum Pause Time

This requirement traces TO SUBREQ35812:  Cessation of Therapy

This requirement traces TO SUBREQ35843:  In READY State Too Long

This requirement traces TO SUBREQ35813:  Softkeys: Therapy Screen

This requirement traces TO SUBREQ36485:  Therapy Abort Conditions

Thisrequirement traces TO SUBREQ35825: Therapy Aborted Screen

 

----

***3.5.2.6  LASER STOP                                                                      ***

***CriticalRequirement                                 Version: 4.0             (SYSREQ35608)***

The console shall provide means for the user to stoptherapy and de-energize the laser via a LASER STOP switch.

When the LASER STOP switch is activated, all power inthe console is interrupted.

Thisrequirement traces TO SUBREQ35974:  LASERSTOP Button

***3.5.2.7  Delivery Device Replacement                                                          ***

***TraceableRequirement                                 Version: 4.0             (SYSREQ35609)***

When the delivery device is removed (detected byoutput port interlocks), all therapy parameters are reset to power up defaults.

This requirement traces TO SUBREQ35838:  Alert: Output Port Interlock

Thisrequirement traces TO SUBREQ35982:  SetupPameters Reset On Device Replacement

***3.5.3  Outputs                                                                          ***

***Section Heading                                  Version:1.5              (SYSREQ35610)***

 

***3.5.3.1  Laser Energized                                                                  ***

***TraceableRequirement                                 Version: 2.2              (SYSREQ35611)***

The console shall provide a visual and audibleindication to the user whenever the laser is energized.

This requirement traces TO SUBREQ35811:  Audible & Visible Indication ofLaser On

Thisrequirement traces TO SUBREQ35904:  AudioTransducer

***3.5.3.1.1  Irrigation Prompt                                                                      ***

***TraceableRequirement                                 Version: 3.2             (SYSREQ35612)***

The console shall providea prompt to the user before activating the laser regarding device irrigation.

 

Thisrequirement traces TO SUBREQ36418: Delivery Device Irrigation Check Screen

***3.5.3.2  Laser State                                                                           ***

***CriticalRequirement                                 Version: 2.3             (SYSREQ35613)***

The console shall visually indicate to the user thecurrent state of the laser as being STANDBY, READY or ACTIVE.

Thisrequirement traces TO SUBREQ35769: Displayed Elements

----

 

***3.5.3.3  Programmed Power                                                                           ***

***CriticalRequirement                                 Version: 2.2             (SYSREQ35614)***

The console will indicate programmed therapy powerwith a resolution of [**]

Thisrequirement traces TO SUBREQ35808: Parameters Displayed

***3.5.3.4  Remaining Therapy Time                                                                 ***

***CriticalRequirement                                 Version: 2.2             (SYSREQ35615)***

The console will indicate remaining therapy time witha resolution of [**], to the user whenever the laser is energized .

This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer

This requirement traces TO SUBREQ35808:  Parameters Displayed

Thisrequirement traces TO SUBREQ35810:  UICCountdown Therapy Timer

***3.5.4  System Alerts                                                                ***

***TraceableRequirement                                 Version: 3.3             (SYSREQ35616)***

Upon detection ofan alert condition, the UI shall generate visual and audible indications. [**]

 

This requirement traces TO SYSREQ35617:  Alert Conditions

This requirement traces TO SYSREQ35618:  Alerts Suppressed During Therapy

This requirement traces TO SUBREQ35812:  Cessation of Therapy

This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**

This requirement traces TO SUBREQ35832:  Alerts/Alarms Visible & Audible

This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy

This requirement traces TO SYSREQ35619:  Device Response: Alert

 

***3.5.4.1  Alert Conditions                                                                 ***

***TraceableRequirement                                 Version: 4.4             (SYSREQ35617)***

The console shall indicate the following alertconditions to the user:

[**]

This requirement traces FROM SYSREQ35616:  System Alerts

This requirement traces TO SUBREQ35844:  Alert: Fan Failure

This requirement traces TO SUBREQ35838:  Alert: Output Port Interlock

This requirement traces TO SUBREQ35842:  Alert: OverTemp

Thisrequirement traces TO SUBREQ35839: Alert: Remote Interlock

***3.5.4.2  Alerts Supressed During Therapy                                   ***

***TraceableRequirement                                 Version: 2.1             (SYSREQ35618)***

During therapy, the following alerts are suppressed. [**]

[**]

This requirement traces FROM SYSREQ35616:  System Alerts

This requirement traces TO SUBREQ35844:  Alert: Fan Failure

This requirement traces TO SUBREQ35842:  Alert: OverTemp

Thisrequirement traces TO SUBREQ35834: Alerts Supression

----

*** ***

***3.5.4.3  Device Response: Alert                                                                     ***

***TraceableRequirement                                 Version: 5.3              (SYSREQ35619)***

In the event of an alert condition, the console shallrespond according to the alert response table. Note that the responses vary bywhat state the laser is in.

[**]

 

| Alert | ** ** | **STANDBY** | ** ** | **READY**  | ** ** | **ACTIVE** |
|-------|------------|-------------|------------|------------|------------|------------|
| [**]  |       | [**]        |       | ð[**] |       | [**]       |
| [**]  |       | ð[**]  |       | ð[**] |       | ð[**] |
| [**]  |       | ð[**]  |       | ð[**] |       | ð[**] |
| [**]  |       | ð[**]  |       | ð[**] |       | ð[**] |
| [**]  |       | ð[**]  |       | ð[**] |       | ð[**] |

 

This requirement traces FROM SYSREQ35616:  System Alerts

This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**

This requirement traces TO SUBREQ35834:  Alerts Supression

This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy

This requirement traces TO SUBREQ35835:  Performing Therapy after an Alert

This requirement traces TO SUBREQ35838:  Alert: Output Port Interlock

This requirement traces TO SUBREQ35844:  Alert: Fan Failure

This requirement traces TO SUBREQ35839:  Alert: Remote Interlock

Thisrequirement traces TO SYSREQ35607: Therapy Abort

***3.5.5  System Alarms                                                                             ***

***TraceableRequirement                                  Version: 3.3              (SYSREQ35620)***

Upon detection of an alarm condition, the UI shallgenerate a visual and audio alarm. Alarm indications must occur within [**]ofdetection of an alarm condition. [**]

This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**

This requirement traces TO SUBREQ35832:  Alerts/Alarms Visible & Audible

This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy

This requirement traces TO SUBREQ35812:  Cessation of Therapy

 

***3.5.5.1  Alarm Conditions                                                                               ***

***TraceableRequirement                                 Version: 2.3             (SYSREQ35621)***

The console shall indicate the following alarmconditions to the user:

[**]

This requirement traces TO SUBREQ35848:  Alarm: Inaccurate Laser Power

This requirement traces TO SUBREQ35849:  Alarm: POST Failed

This requirement traces TO SUBREQ35760:  Power Up Tests

Thisrequirement traces TO SUBREQ35761: Run-Time Diagnostics

----

 

***3.5.5.2  Device Response: Alarm                                                                   ***

***TraceableRequirement                                 Version: 2.1             (SYSREQ35622)***

In the event of an alarm condition, [**]

This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**

This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy

This requirement traces TO SUBREQ35833:  Alarm Silencing

This requirement traces TO SUBREQ35836:  Performing Therapy after an Alarm

 

***3.5.6  Service/Engineering Mode                                                                       ***

***TraceableRequirement                                 Version: 5.3             (SYSREQ35623)***

The UI shall includea service/engineering mode of operation through the UI which provides [**]

 

This requirement traces TO SUBREQ35863:  Accessing Service Screen

This requirement traces TO SUBREQ35865:  Service Screen Options

This requirement traces TO SUBREQ36690:  TSS BIT Screen

This requirement traces TO SUBREQ36536:  Set TSS BIT Params

This requirement traces TO SUBREQ35873:  Dump Device Number History Log

This requirement traces TO SUBREQ35866:  Display Event Log

This requirement traces TO SUBREQ36533:  View System Runtime

 

***3.5.6.1  Hours of Use                                                                        ***

***TraceableRequirement                                 Version: 2.3             (SYSREQ35624)***

In service/engineering mode, the system shall becapable of displaying “hours of use” of the laser diode module. [**]

[**]

Thisrequirement traces TO SUBREQ35892:  LaserUsage Time

***3.5.6.1.1  Reset Hours of Use                                                                    ***

***TraceableRequirement                                 Version: 2.1             (SYSREQ35625)***

The console shall providea means to reset the “Hours Of Use” when a laser module is replaced.

 

Thisrequirement traces TO SUBREQ35871:  ResetLaser Usage timer

***3.5.6.2  Constant Current Mode                                                                    ***

***TraceableRequirement                                 Version: 2.0             (SYSREQ35626)***

In service/engineering mode, the system shall providemeans for running the laser in constant current mode. [**]

Thisrequirement traces TO SUBREQ36466:  SetConstant Current Mode

***3.5.6.3  Power Calibration Mode                                                                  ***

***TraceableRequirement                                 Version: 1.7             (SYSREQ35627)***

In service/engineering mode, the system shall providemeans for the user (service personnel) to perform a power calibration of thelaser.

Thisrequirement traces TO SUBREQ35943: Store/Read Laser Calibration Data

----

*** ***

***3.5.6.4  Current Calibration Mode                                                                               ***

***TraceableRequirement                                 Version: 1.10             (SYSREQ36411)***

In service/engineering mode, the system shall providemeans for the user (service personnel) to perform a current calibration of thelaser.

Thisrequirement traces TO SUBREQ36486: Store/Read Laser Current Calibration Data

***3.5.6.5  TSS Calibration                                                                  ***

***TraceableRequirement                                 Version: 1.7             (SYSREQ35628)***

The system shall provide a means to calibrate theThermal Safety System from within the Service Mode.

This requirement traces TO SUBREQ35969:  Read Thermal Safety System Information

Thisrequirement traces TO SUBREQ36463:  StoreTSS Calibration Data

***3.5.7  UI Components                                                                            ***

***Section Heading                                  Version: 1.5              (SYSREQ35629)***

** **

***3.5.7.1  Display and Keypad                                                                           ***

***Section Heading                                  Version:1.6              (SYSREQ35630)***

* *

***3.5.7.1.1  Viewability                                                                  ***

***TraceableRequirement                                 Version: 1.5             (SYSREQ35631)***

All electronically displayed information must bereadable from [**]

Thisrequirement traces TO SUBTST36182:  TestProtocol 007 - Viewability

***3.5.7.1.2  Display Angle                                                                             ***

***TraceableRequirement                                  Version: 1.6              (SYSREQ35632)***

The display shall be mounted [**]

Thisrequirement traces TO SUBTST36182:  TestProtocol 007 - Viewability

***3.5.7.1.3  Room Lighting                                                                           ***

***DesignGuideline                                 Version: 1.4              (SYSREQ35633)***

All user data must bevisible [**]

***3.5.7.1.4  Keypad Actuation Force                                                          ***

***TraceableRequirement                                 Version: 2.0             (SYSREQ35634)***

All user-input keys shallhave an actuation force between [**]

 

This requirementtraces TO SUBTST37660:  Test Protocol 003- Keypad Force

----

*** ***

***3.5.7.1.5  Foreign Languages                                                                   ***

***FutureEnhancement                                 Version: 3.2             (SYSREQ35735)***

The laser console mustsupport the following foreign language requirements: [**]

 

***3.5.7.1.6  Device Labeling                                                                         ***

***TraceableRequirement                                 Version: 3.7             (SYSREQ36192)***

Device labeling shall bein [**]

 

This requirement traces TO SUBREQ35861:  Languages

This requirement traces TO SUBREQ35767:  Languages

 

***3.5.7.2  LASER STOP Switch                                                                         ***

***CriticalRequirement                                 Version: 4.0             (SYSREQ35635)***

The console shall have a red laser stop switch on thefront or top of the console. [**]

Thisrequirement traces FROM SUBFMA36068:  OIClocked-up during therapy - loss of optical system controlThis requirement traces TO SUBREQ35974: LASER STOP Button

***3.5.7.3  Footswitch                                                                           ***

***CriticalRequirement                                 Version: 4.1              (SYSREQ35636)***

The system shall include a footswitch, [**]

Thisrequirement traces TO SUBTST37661:  TestProtocol 004 - Footswitch

***3.5.7.4  Audio Transducer                                                                              ***

***TraceableRequirement                                 Version: 3.0              (SYSREQ35637)***

The system shall include a monotone audio transducer[**]

Thisrequirement traces TO SUBREQ35904:  AudioTransducer

***3.6  Device Event Log                                                                 ***

***TraceableRequirement                                 Version: 2.2             (SYSREQ35638)***The console shall be capable of storing a history of theevents in non-volatile memory.

[**]

This requirement traces TO SUBREQ35878:  Common Format

This requirement traces TO SUBREQ35877:  Number of Events

 

***3.6.1  Power On                                                                      ***

***TraceableRequirement                                  Version: 3.1              (SYSREQ35640)***

An event will becreated when the console is powered on.

 

[**].

Thisrequirement traces TO SUBREQ35880: Event: Power Up

----

*** ***

***3.6.2  Change in Operation State (STANDBY, READY,ACTIVE)***

***TraceableRequirement                                 Version: 2.2             (SYSREQ35641)***

An event will berecorded when the laser changes between STANDBY, READY, and ACTIVE mode.

 

This requirement traces TO SUBREQ35882:  Event: Go To Ready

This requirement traces TO SUBREQ35886:  Event: Therapy Abort

This requirement traces TO SUBREQ35885:  Event: Therapy Resume

This requirement traces TO SUBREQ35884:  Event: Therapy Pause

This requirement traces TO SUBREQ35887:  Event: Therapy Complete

This requirement traces TO SUBREQ35880:  Event: Power Up

This requirement traces TO SUBREQ36468:  Event: Alarm

This requirement traces TO SUBREQ35888:  Event: Alert

This requirement traces TO SUBREQ35883:  Event: Therapy Start

 

***3.6.3  Therapy Start                                                                               ***

***TraceableRequirement                                  Version: 1.5              (SYSREQ35642)***

An event will be generated when Therapy is started.

[**]

Thisrequirement traces TO SUBREQ35883: Event: Therapy Start

***3.6.4  Therapy Complete                                                                      ***

***TraceableRequirement                                  Version: 2.2              (SYSREQ35643)***

An event will be created when Therapy Completes.

[**]

Thisrequirement traces TO SUBREQ35887: Event: Therapy Complete

***3.6.5  Therapy Paused                                                                           ***

***TraceableRequirement                                 Version: 1.5             (SYSREQ35644)***

An event entry will be created when Therapy is Paused.

[**]

Thisrequirement traces TO SUBREQ35884: Event: Therapy Pause

***3.6.6  Alert or Alarm Occurance                                                                         ***

***TraceableRequirement                                 Version: 1.6             (SYSREQ35645)***

A device history event entry will be made for anyalert or alarm condition.

[**]

Thisrequirement traces TO SUBREQ36468: Event: AlarmThis requirement traces TO SUBREQ35888: Event: Alert

----

*** ***

***3.7  External Serial Port                                                                            ***

***TraceableRequirement                                 Version: 2.2             (SYSREQ35646)***The console shall include an external serial interfaceport.

Thisrequirement traces TO SUBREQ35988: Serial Port

***3.7.1  Available Data                                                                            ***

***DesignGuideline                                 Version: 2.4             (SYSREQ35647)***

Data available via the external serial port includesthe following:

[**]

***3.7.2  Physical Implementation                                                                          ***

***TraceableRequirement                                 Version: 1.5              (SYSREQ35648)***

The serial interface will be implemented [**]

This requirement traces TO SUBREQ35989:  Connector

This requirement traces TO SUBREQ35990:  Pinout

 

***3.7.3  Baud Rate                                                                     ***

***TraceableRequirement                                 Version: 1.10             (SYSREQ35649)***

The externalserial port shall provide communications at a baud rate of [**]

 

Thisrequirement traces TO SUBREQ35932: Serial Port Parameters

***3.8  Regulatory Requirements                                                                  ***

***Section Heading                                  Version: 1.5              (SYSREQ35650)***

***3.8.1  Device Classifications                                                                ***

***DesignGuideline                                 Version: 4.0             (SYSREQ35651)***

The Laser Consoleshall be designed to meet the requirements of the following safety andregulatory classifications:

 

[**]

 

***3.8.2  U.S. Regulatory                                                                           ***

***CriticalRequirement                                 Version: 5.0             (SYSREQ35652)***

** **

The console shallbe designed and verified to comply with the following standards.

 

UL 60601-1 MedicalElectrical Equipment, PART 1: General Requirements for Safety

 

21 CFR 1040.10 and1040.11 Performance Standards for Light Emitting Products, except fordeviations pursuant to CDRH Laser Notice No. 50

 

Thisrequirement traces TO SUBTST36177:  TestProtocol 001 - Safety Regulations

----

*** ***

***3.8.3  O.U.S. Regulatory                                                                       ***

***CriticalRequirement                                 Version: 15.0             (SYSREQ35653)***

The console shallbe designed and verified to comply with the following standards:

 

CAN/CSA C22.2 No. 601-1M90 - Except Languages

Medical ElectricalEquipment - PART 1: General Requirements For Safety

 

EN 61000-3-2Electromagnetic Compatibility (EMC) - Part 3-2: Limits - Limits forHarmonic Current Emissions (Equipment Input Current <= 16 A per Phase)

 

EN 61000-3-3Electromagnetic Compatibility (EMC) - Part 3-3: Limits - Limitationof Voltage Changes, Voltage Fluctuations and Flicker in Public Low-VoltageSupply Systems, for Equipment With Rated Current <= 16 A per Phase and NotSubject to Conditional Connection)

 

CISPR 11 / EN55011 Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment -Electromagnetic Disturbance Characteristics - Limits and Methods of Measurement

 

IEC 60601-1/ BS EN 60601-1 Medical Electrical Equipment - PART 1: GeneralRequirements For Safety

 

IEC 60601-1-2/ EN 60601-1-2 Medical Electrical Equipment - Part 1: GeneralRequirements for Safety, Section 2 - Collateral Standard: ElectromagneticCompatibility - Requirements and Tests

 

IEC 60825-1/BS EN 60825-1 Safety of Laser Products - Part 1: EquipmentClassification, Requirements And User’s Guide

 

IEC 60601-1-4/ EN 60601-1-4 Medical Electrical Equipment - Part 1-4:General Requirements for Safety -

 

CollateralStandard: Programmable Electrical Medical Systems

 

Thisrequirement traces TO SUBTST36177:  TestProtocol 001 - Safety Regulations

***3.9  General Safety Requirements                                                                            ***

***Section Heading                                  Version:1.5              (SYSREQ35654)***

***3.9.1  Fail-safe Condition                                                                    ***

***DesignGuideline                                  Version: 2.2              (SYSREQ35655)***

The console must “fail-safely” in the event of a [**]

***3.9.2  System Diagnostics                                                                     ***

***CriticalRequirement                                 Version: 2.4             (SYSREQ35656)***

The console shouldinclude appropriate diagnostics and self-tests [**]

 

This requirement traces TO SUBREQ35760:  Power Up Tests

This requirement traces TO SUBREQ35832:  Alerts/Alarms Visible & Audible

This requirement traces TO SUBREQ35849:  Alarm: POST Failed

This requirement traces TO SUBREQ35761:  Run-Time Diagnostics

 

----

*** ***

***3.9.3  Power On Self Tests                                                                    ***

***CriticalRequirement                                 Version: 6.2             (SYSREQ35657)***

Start-up selftests shall test or monitor the following functional blocks:

[**]

 

Thisrequirement traces TO SUBREQ35760:  PowerUp Tests

***3.9.4  Single Fault Impact                                                                   ***

***DesignGuideline                                 Version: 1.4             (SYSREQ35658)***

Except for faultsthat trigger a LASER SHUTOFF condition, no single fault condition shall changethe laser output [**]

 

***3.9.5  Defibrillator Proof                                                                      ***

***TraceableRequirement                                 Version: 4.0             (SYSREQ35659)***The console shall be defibrillator proof.

[**]

Thisrequirement traces TO SUBTST36178:  TestProtocol 002 - Defibrillator Proof

***3.9.6  Watchdog Timers                                                                        ***

***CriticalRequirement                                 Version: 3.4             (SYSREQ35661)***

The [**], will bemonitored by watchdogs.

 

This requirement traces TO SUBREQ35923:  Heartbeat

This requirement traces TO SUBREQ36470:  OIC Watchdog

This requirement traces TO SUBREQ36469:  UIC Watchdog

 

***3.10  Power Requirements                                                                         ***

***Section Heading                                  Version:1.6              (SYSREQ35662)***

 

Thisrequirement traces TO SYSREQ36464:  PowerKey Switch

***3.10.1  AC Power Source                                                                           ***

***TraceableRequirement                                 Version: 2.2             (SYSREQ35663)***

The console’s [**]power source will be AC line power (Mains voltage).

 

Thisrequirement traces TO SUBTST36156:  TestProtocol 002 - Mains Power

***3.10.2  Mains Tolerances                                                                          ***

***TraceableRequirement                                 Version: 3.0             (SYSREQ35664)***

The console willsupport [**]

 

Thisrequirement traces TO SUBTST37664:  TestProtocol 003 - Input Voltage Range

 

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## *** ***

## ***3.10.3 Mains Receptacle                  Critical Requirement                      Version:2.2     (SYSREQ35665)***The console power input shall incorporate an [**]

Thisrequirement traces TO SUBTST36156: Test Protocol 002 - Mains Power

## ***3.10.4 UL Recognized Components          Critical Requirement                      Version:1.6     (SYSREQ35666)***AC mains components must be UL recognized.

Thisrequirement traces TO SUBREQ35977: AC Components UL ListedThis requirement traces TO SUBTST36156: Test Protocol 002 - Mains Power

## ***3.10.5 Power Status LED          Critical Requirement                 Version: 2.2          (SYSREQ35667)***The console shall have an LED on the front panel indicating that poweris on.

Thisrequirement traces TO SUBREQ35976: Power On Indicator

## ***3.10.6 Mains Fused      Critical Requirement                 Version: 2.2          (SYSREQ35668)***The console will have fuses in the mains.

Thisrequirement traces TO SUBTST36156: Test Protocol 002 - Mains Power

## ***3.10.7 Isolation             Critical Requirement                 Version: 1.5          (SYSREQ35669)***Applied parts will be electrically isolated from secondary circuits andearth ground [**]

Thisrequirement traces TO SUBTST36172: Test Protocol 002 - EMC / EMI

## ***3.10.8 Power Key Switch          Traceable Requirement             Version:3.1          (SYSREQ36464)***The console shall have a front panel key switch, which energizes theconsole.

Thisrequirement traces FROM SYSREQ35662: h Power Requirements

Thisrequirement traces TO SUBTST36181: Test Protocol 001 - Enclosure

## ***3.11 Physical Requirements               Section Heading******                    Version: 1.5          (SYSREQ35670)***

## ***3.11.1 Size      Design Guideline        Version:2.2          (SYSREQ35671)***The maximum footprint of the laser console should be [**]

----

 

***3.11.2 Weight                Design Guideline        Version:2.2          (SYSREQ35672)***The weight of the total laser console, unpackaged, should be less thanor equal to [**].

##  

***3.11.3 Forced Air         Traceable Requirement             Version:2.3          (SYSREQ35673)***Internal temperature control for the laser console shall be implementedvia forced air cooling.

 

Thisrequirement traces TO SUBTST37663: Test Protocol 006 - Internal Cooling

***3.11.4 AC Power Cable Length                 Critical Requirement                 Version: 2.2          (SYSREQ35674)***The console power cable connecting to AC power shall be [**]

 

Thisrequirement traces TO SUBTST36156: Test Protocol 002 - Mains Power

***3.12 Environmental Requirements  Section Heading                 Version: 1.5          (SYSREQ35675)***The following sections provide environmental requirements that are inaddition to requirements stipulated by the standards noted in Section 1.2.1.

 

***3.12.1 Operating Conditions******           Section Heading         Version:1.5          (SYSREQ35676)***

*** ***

## **3.12.1.1 AmbientTemperature                  Traceable Requirement             Version:2.2         (SYSREQ35677)**The console will operate over an ambient temperature range of [**].

Thisrequirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity

## ***3.12.1.2 Humidity         Traceable Requirement             Version:2.2          (SYSREQ35678)***The console will operate over a relative humidity range of [**].

Thisrequirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity

## ***3.12.1.3 ESD******                                                Traceable Requirement            Version:3.0          (SYSREQ35679)***During IEC 60601-1-2 specified ESD exposure, [**]

Thisrequirement traces TO SUBTST36172: Test Protocol 002 - EMC / EMI

----

##  

## ***3.12.1.4 EMI             Traceable Requirement        Version:7.0          (SYSREQ35680)***The console shall meet EMI exposure requirements specified in [**].

Thisrequirement traces TO SUBTST36172: Test Protocol 002 - EMC / EMI

## ***3.12.1.5 Drip Proof               Critical Requirement            Version:4.0          (SYSREQ35681)***The console will be drip proof per [**].

Thisrequirement traces TO SUBTST36173: Test Protocol 003 - Drip Proof

## ***3.12.1.6 Surface Temperature             Critical Requirement            Version:2.2          (SYSREQ35682)***Surface temperature of the laser console shall not exceed [**] when theunit is operating in the defined ambient temperature range.

Thisrequirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity

## ***3.12.1.7 Unpackaged Drop Test        Traceable Requirement        Version:5.0          (SYSREQ35683)***The console shall withstand a [**]

Thisrequirement traces TO SUBTST36174: Test Protocol 004 - Drop and Vibration

## ***3.12.1.8 Unpackaged Vibration Test  Traceable Requirement        Version:4.1          (SYSREQ35684)***The console must function properly in the presence of vibration per[**]

Thisrequirement traces TO SUBTST36174: Test Protocol 004 - Drop and Vibration

## ***3.12.1.9 Chemical Exposure              Traceable Requirement        Version:1.6          (SYSREQ35685)***Exposed surfaces must withstand wiping (not scrubbing) with [**]

Thisrequirement traces TO SUBTST37563: Test Protocol 007 - Chemical Exposure

## ***3.12.2 Storage and Transport Conditions******                      Section Heading                    Version:1.5          (SYSREQ35686)***

## ***3.12.2.1 Humidity    Traceable Requirement        Version:2.2          (SYSREQ35687)***The console while packaged must withstand exposure of [**]

Thisrequirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity

----

##  

## ***3.12.2.2 Temperature              Traceable Requirement        Version:2.2          (SYSREQ35688)***The console while packaged must withstand environment temperatures from[**] and remain capable of proper functionality when returned to normaloperating conditions.

Thisrequirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity

## ***3.12.2.3 Shock and Vibration            Traceable Requirement        Version:5.1          (SYSREQ35689)***The console while packaged must withstand the environmental extremesidentified in [**]

Thisrequirement traces TO SUBTST36175: Test Protocol 005 - Shipping

## ***3.13 Quality Requirements                 Section Heading                 Version: 1.5          (SYSREQ35690)***

## ***3.13.1 Verification Testing      Traceable Requirement             Version:2.2          (SYSREQ35691)***[**]

Thisrequirement traces TO SUBTST36179: Test Protocol 003 - Development Processes

## ***3.13.2 Testability          Design Guideline        Version:1.4          (SYSREQ35692)***[**]

## ***3.14 Manufacturing Guidelines        Section Heading                 Version: 1.5          (SYSREQ35693)***

## ***3.14.1 In-circuit Programming for Programmable Devices Design Guideline        Version:1.4          (SYSREQ35694)***Programmable electronic devices should be designed for in-circuitprogramming where possible.

## ***3.14.2 System MTBF Design Guideline        Version:2.2          (SYSREQ35695)***Mean time between failure (MTBF) for the console shall be [**].

## ***3.15 Service Guidelines       Section Heading                 Version: 1.5          (SYSREQ35696)***

## ***3.15.1 Software Upgrades           Design Guideline        Version:3.2          (SYSREQ35697)***Software upgrades for the console must be easily installed [**].

----

 

## ***3.15.2 Not User Serviceable       Critical Requirement                 Version: 2.2          (SYSREQ35698)***The console is not intended to be user serviceable.

Thisrequirement traces TO SUBTST36184: Test Protocol 008 - Not User Serviceable

## ***3.16 Future Upgradeability               Future Enhancement         Version:3.2          (SYSREQ35699)***The laser system design should include consideration of the followingpotential feature or functional upgrades. [**]

## ***3.17 Irrigation Control       Section Heading                 Version: 2.3          (SYSREQ35700)***This section describes the irrigation control in the console.

## ***3.17.1 Pinch Valve       Traceable Requirement             Version:4.0          (SYSREQ35701)***There will be a pinch valve in the system [**]

Thisrequirement traces TO SUBREQ35996: Pinch Valve External

## ***3.17.2 Pinch Valve Shutoff when TSS Trips         Traceable Requirement             Version:1.5          (SYSREQ35702)***The pinch valve shall close when the Thermal Safety System trips.

Thisrequirement traces TO SUBREQ35998: Pinch Valve & TSS Shutoff

## ***3.17.3 Activated During Footswitch Down          Traceable Requirement             Version:2.2          (SYSREQ35703)***The Pinch Valve will have a normally closed position. The pinch valvewill open when the footswitch is depressed during therapy.

Thisrequirement traces TO SUBREQ35997: Pinch Valve Operation

## ***3.17.4 Irrigation - Softkey Activation   Traceable Requirement             Version:2.5          (SYSREQ36414)***The device shall be capable of pinch valve control, via softkeycontrol, while not in therapy mode.

Thisrequirement traces TO SUBREQ35997: Pinch Valve OperationThis requirement traces TO SUBREQ36424: Softkeys: Delivery Device Irregation

## ***3.18 Laser Output Specific Requirements       Section Heading                 Version: 2.6          (SYSREQ35726)***

----

 

## ***3.18.1 Wavelength        Traceable Requirement             Version:2.2          (SYSREQ35727)***The console shall be capable of producing output laser energy at awavelength of [**]

Thisrequirement traces TO SUBREQ36006: Wavelength

## ***3.18.2 Power                Traceable Requirement             Version:6.2          (SYSREQ35728)***The console shall be capable of coupling laser energy [**]

[**]

Thisrequirement traces TO SUBREQ36007: Power

## ***3.18.3 Max Power Allowed        Traceable Requirement             Version:2.4          (SYSREQ35729)***The Max Power allowed by the setup parameters shall be [**]

Thisrequirement traces TO SUBREQ36008: Max Power Allowed

## ***3.18.4 Aiming Beam    Traceable Requirement             Version:1.6          (SYSREQ35731)***There will be an aiming beam. [**]

Thisrequirement traces TO SUBREQ36010: Red Aiming Beam

## ***3.18.5 Therapy Delivery Device Parameters         Traceable Requirement             Version:9.0          (SYSREQ35733)***

[**]
|   |   | [**] |   | [**] |   |
|--------|--------|------|--------|------|--------|
| [**]   |   | [**] |   | [**] |   | [**] |   | [**] |   | [**] |   | [**] |   |
| [**]   |   | [**] |   | [**] |   | [**] |   | [**] |   | [**] |   | [**] |   |

[**]
| ** ** | ** ** | [**] |   | [**] | ** ** |
|------------|------------|------|--------|------|------------|
| [**]       |       | [**] |   | [**] |       | [**] |   | [**] |   | [**] |   | [**] |   |
| [**]       |       | [**] |   | [**] |       | [**] |   | [**] |   | [**] |   | [**] |   |

[**]

Thisrequirement traces TO SUBREQ36013: Therapy Device Parameters

## ***3.18.6 Product Name                 Design Guideline        Version:5.0          (SYSREQ35734)***The console shall be labeled “Model 60980: Optiwave 980TM Laser Console”.

----

 

## ***3.18.7 System Cost Target          Design Guideline        Version:1.5          (SYSREQ35736)***The manufacturing cost of the device [**]

 

----

** **

**Schedule 2.1(a)****Universal FunctionalitySpecifications**

The UniversalFunctionality Specifications shall mean the following changes to thespecifications set out as Exhibit A above:

Section 3.5.2.2.2Delivery Device Number Format the word **Endocardia****l** will be deleted and replaced with the word **Universal**

Section 3.18.5Therapy Delivery Device Parameters the word **Endocardia****l** will be deleted and replaced with the word **Universal.**Need to also change abbreviation“(Endo)” to “(Uni)”

Section 3.18.5Therapy Delivery Device Parameters under Power in W/cm2 the Range of **[**]** is being replaced **with [**]**

Section 3.18.5Therapy Delivery Device Parameters under Duration in Seconds the Range of **[**]** is being replaced with **[**]**

----

 

**Schedule 2.4****Endo Handpiece Inventory**

 
| **PLC Part #** | ** ** | **Edwards  Part #** | ** ** | **Description (Edwards)** | ** ** | **Exp. Date** | ** ** | **Qty on  Hand** | ** ** | **PLC Cost $** | ** ** | **PLC EXT Cost** | ** ** |
|--------------------------|------------|--------------------------|------------|--------------------------------|------------|--------------------|------------|-----------------------|------------|--------------------------|------------|----------------------------|------------|
| [**]                     |       | [**]                     |       | [**]                           |       |               |       | [**]                  |       | $                        | [**]       |                       | $          | [**] |   |
| [**]                     |       | [**]                     |       | [**]                           |       | [**]               |       | [**]                  |       | $                        | [**]       |                       | $          | [**] |   |
| [**]                     |       | [**]                     |       | [**]                           |       |               |       | [**]                  |       | $                        | [**]       |                       | $          | [**] |   |
| [**]                     |       | [**]                     |       | [**]                           |       |               |       | [**]                  |       | $                        | [**]       |                       | $          | [**] |   |
| [**]                     |       | [**]                     |       | [**]                           |       |               |       | [**]                  |       |                     |       | $                          | [**]       |   |
|                     |       |                     |       |                           |       |               |       |                  |       |                     |       |                       |       |
| Total                    |       |                     |       |                           |       |               |       |                  |       |                     | ** ** | **$**                      | **[**]**   | ** ** |

 

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Schedule 3.12

Regulatory Approvals

1.               PLC shall file the2005 Annual Laser Product Report with the FDA

2.               PLC shall send aNotification Letter to the FDA transferring ownership of the Laser and 510Kfrom PLC to Edwards.

 

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