EXHIBIT 10.15
SeaMED
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A XXXXXX.Xxxxxxx
Professional Services Agreement
(For Use with Manufacturing Services for Medical Customers Only)
This Agreement is hereby entered into on this 17th day of February, 2000 by and
between Xxxx Medical Systems, Inc., of 000 X. Xxxxxxxxx Xxxxxxxxx, Xxxxxxxx
Xxxx, XX 00000, (hereinafter "Customer") and Plexus Corp. of 00 Xxxxxxxx Xxxx
Xxxxx, Xxxxxx, XX 00000, (along with its wholly-owned subsidiaries Plexus
Technology Group, Plexus Electronic Assembly and SeaMED, a Plexus Company,
hereafter collectively referred to as "Plexus".)
A. MANUFACTURING PHASE
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The terms and conditions set forth in this Section A, Manufacturing Phase,
Section B, Medical Device Provisions, as well as the terms and conditions set
forth in Section C, Standard Terms and Conditions, shall be applicable to this
portion of the Agreement. The parties may conduct a mutual review of component
pricing, material xxxx-up, and labor on a semi-annual basis. Unit prices shall
not be increased or decreased more often than semi-annually unless the quantity
on order changes, or in the event of an engineering change that impacts either
material or labor costs. Unit prices shall be determined for the quantity of
Product on an individual Customer Purchase Order. (For example, if Customer
orders 200 units, the 200 piece price shall apply. If the Customer's next
Purchase Order is for 50 units, the 50 piece price shall apply.) Attachment C
provides an example of unit cost calculations for various production rates. As
part of the semi-annual reviews, Plexus shall review unit costs at various
production rates and shall provide Customer with updated unit costs at these
production rates. Customer's Purchase Orders for quantities outside the scope of
Attachment C shall be mutually negotiated. The estimated quantity of Products is
a factor used to determine unit pricing. In the event of a significant quantity
change, either increasing or decreasing the estimated quantity of assemblies,
the parties agree to evaluate and negotiate the impact and timing of unit price
adjustments.
1. DEFINITIONS
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For the purpose of this Manufacturing Phase:
"Assemblies" shall mean finished Product.
"Long Lead Time Component(s)" shall mean all of those individual parts and
materials whose current lead times extend beyond forty (40) business days. The
Long Lead Time Components may, from time to time, be reviewed by Plexus and
Customer, at the request of either party due to possible changes in market
conditions of supply and demand affecting the procurement by Plexus of the
Components and/or Long Lead Time Components for the assemblies hereunder. Any
changes resulting from such review shall be with the mutual written agreement of
Plexus and Customer.
"NCNR Component(s)" shall mean those parts that are not cancelable once placed
on order with Plexus suppliers, and are not returnable once delivered to Plexus.
The NCNR Component(s) may, from time to time, be reviewed by Plexus and
Customer, at the request of either party due to possible changes in market
conditions of supply and demand affecting the procurement by Plexus of the
Components and/or NCNR Component(s) for the assemblies hereunder. Any
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
changes resulting from such review shall be with the mutual written agreement of
Plexus and Customer.
"Special Component(s)" shall mean those parts that have special procurement
conditions such as limited change parameters or other special liability
conditions that are required by Plexus' suppliers. The Special Component(s) may,
from time to time, be reviewed by Plexus and Customer, at the request of either
party due to possible changes in market conditions of supply and demand
affecting the procurement by Plexus of the Components and/or Special
Component(s) for the assemblies hereunder. Any changes resulting from such
review shall be with the mutual written agreement of Plexus and Customer.
"Monthly Rolling Quantity Forecast of Delivery Requirements" shall mean the
written documents provided to Plexus by Customer each month indicating the
delivery requirements projected for the next twelve (12) months.
2. AUTHORIZATION OF WORK/PROCUREMENT OF MATERIALS
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The following terms will apply assuming Customer's credit has been established
to Plexus' satisfaction:
a) The purpose of this section is to define the methods under which Plexus
will procure materials to support manufacturing of product for the Customer. The
intent is to provide the Customer with flexibility to alter and/or cancel
schedules within a reasonable period of time while at the same time minimizing
Plexus liability that is a result of those alterations and cancellations. In
order to offer the best possible price, Plexus does not attempt to build
unanticipated carrying charges into its price. When changes in Customer
requirements occur that cause Plexus to incur unanticipated expenses that are
the result of Customer actions, the Customer is expected to reimburse Plexus for
the costs incurred.
For each assembly to be manufactured, Plexus establishes a manufacturing lead
time, which is the number of business days it will take, on average, to receive
and kit all components, assemble, test and ship the lot. Manufacturing lead time
shall be established during the pre-production phase of the program. Plexus
schedules all components for a particular lot of assemblies to arrive one
manufacturing lead-time prior to the Customer due date. Plexus then uses this
information, together with the Forecast and Purchase Order information as
defined below, to place commitments to its suppliers for materials.
b) Customer shall place purchase orders for the first six (6) months of
production and maintain six (6) months of firm purchase orders on a month to
month rolling basis. Customer will provide Plexus on a monthly basis with a
minimum of twelve (12) month schedule of demand for product. The schedule will
show firm orders for months 1-6 and forecasted demand for months 7/12. Customer
authorizes Plexus to procure, as material lead times dictate, the material to
support 100% of Buyers forecasted requirements for months 7 through 9. On a
quarterly basis Plexus will place orders for material for months 7 through 9 of
the current forecast in order to lot size Printed Circuit Board Assemblies and
to determine economic order quantity buys or components or unique parts. Months
10, 11 and 12 are provided for Plexus
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
visibility and may be utilized by Plexus to request additional material
authorizations from Customer. Prior to entering full production Customer and
Plexus will review the final xxxx of material, discuss material lead times and
production ordering parameters. Customer and Plexus agree to develop a material
ordering plan which will ensure timely delivery of material to meet production
objectives, while limiting the exposure to materials in the event of a program
shut down.
c) Schedule Changes:
The Customer may request a change to the delivery schedule at any time. Schedule
changes can have an extraordinary effect on the amount of inventory at Plexus,
the impact for which is not considered in the original cost of the assembly.
Frequent schedule changes may result in additional administrative charges
including but not limited to administrative charges required for Plexus to
reschedule component deliveries.
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Customer and Plexus recognize that each program is unique and will require
program specific ordering parameters. These parameters are mutually agreed to
after the xxxx of material is finalized and production quantities are provided
to Plexus in the form of a purchase order or delivery forecast. The parameters
set forth below offer a typical scenario where the Customer may, without cost or
liability, but with the assent of Plexus, reschedule deliveries of Products
already on order. Customer may request to move in delivery dates of quantities
on order. Plexus will complete an analysis of material availability and will
provide Customer with estimated ship dates based on material availability.
Likewise, Customer may request to move out delivery dates of quantities on
order. Plexus will complete an analysis of the impact of this change to material
on hand and on order. If Customer chooses to move out deliveries and material is
already at or shipping to Plexus's facility, Customer may be charged an
inventory deposit for this material as set forth below.
Production Schedule Ordering Parameters
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0 to 3 Months Firm PO's, Schedule unchangeable
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4 to 6 Months Firm P0's. May move up to 20% of scheduled deliveries on
PO's out 30 days without incurring an inventory deposit, or
in 30 days depending on material availability.
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7 to 9 Months May move up to 30% of scheduled deliveries on PO's out 60
days without incurring an inventory deposit, or in 60 days
depending on material availability. Deliveries extended >60
days will require an inventory deposit.
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Customer may request to increase the total quantity of Products on order. For
quantity increases, Plexus will make its best effort to obtain the components
necessary to meet Customer requirements. Plexus will complete an analysis of
material availability and will provide Customer with estimated ship dates based
on material availability. However, Plexus may be unsuccessful in obtaining all
of the components required to meet the Customer's increased requirements. In
that situation, Plexus will complete an analysis of material availability and
will provide Customer with estimated ship dates based on material availability.
Customer may request to decrease the total quantity of Products on order. If
Customer decreases the total quantity of Products on order, all non-cancelable,
non-returnable material procured in accordance with Customer's original Purchase
Order schedule will be the responsibility of Customer.
d) Engineering Change
The term "Engineering Change(s)" (hereinafter called "EC" or "EC's") shall mean
those mechanical, software, or electrical design and/or specification and
requirement changes which, if made to the assemblies to be delivered hereunder,
would affect the schedule performance, reliability, availability,
serviceability, appearance, dimensions, tolerance, safety or purchase price of
such assemblies or which would require additional approval test.
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Plexus may determine that Engineering Changes will affect its ability to
maintain the delivery schedule, due to the lead time of newly specified parts
and/or the impact of substantial rework or modification. Under these
circumstances, Plexus reserves the right to define a new schedule for delivery
and treat this as a Schedule Change, with the Customer liability as defined
under the Schedule Change condition.
Plexus shall process engineering changes per the agreed upon Document Change
Control Agreement, attached hereto and made a part hereof as Attachment A. Upon
receipt, Plexus shall review Customer's proposed EC and Plexus shall give to
Customer a written evaluation of the EC, stating Plexus' cost to implement the
EC (including the cost to modify any tooling), the excess quantity of Components
and/or Long Lead Time Components, NCNR Components and/or Special Components
Plexus has inventoried and/or has on order with its Components and/or Long Lead
Time Components, NCNR Components and/or Special Components suppliers that are
unusable for any other assembly requirement and excess due to the EC, and
associated costs and expenses such Components and/or Long Lead Time Components,
NCNR Components and/or Special Components that Customer shall be liable for and
the cost savings, if any, resulting from the EC, and the expected effect on the
schedule, availability and/or purchase price of such assemblies, or which may
require additional approval tests by Customer.
e) Customer Supplied Parts
In the event the Customer supplies material to Plexus for use in the
manufacturing of the product, Customer agrees to supply the material on time and
in accordance with purchase orders placed by Plexus. Customer supplied material
will be subject to normal incoming inspection, and the value of the incoming
material will be included in the unit price. For purposes of payment relating to
this section only, Plexus and Customer agree to develop a method for providing
Customer with payment for such accepted customer supplied material such that
Customer will not be charged twice for any individual customer supplied
material. If material supplied by Customer is rejected or not delivered on time,
therefore preventing Plexus from completing and shipping product, Plexus may
invoice Customer for the full unit price as listed on Customer's purchase order.
f) Minimum Component Purchases
Plexus may have to place orders for quantities of components in excess of that
required to support Customer requirements. This may be as a result of minimum
order size requirements or standard package sizes from the supplier. Plexus and
Customer will work together using best efforts to identify components that
require or may be likely to require a minimum buy prior to the initial build.
However, the Customer's responsibility for minimum component purchases is not
solely confined to this list since additional components may require minimum buy
purchases at any time. Plexus shall provide Customer with periodic updates as
well as inventory reports showing excess and obsolete components. The Customer
will agree to have the cost of the excess components amortized over a maximum of
six (6) month's requirements, or will place a purchase order separately for the
excess components.
g) Cancellation
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Customer may cancel requirements defined in orders and/or forecasts at any time
before the scheduled delivery date. Any assembly requirements canceled within
the manufacturing lead-time of the scheduled delivery date will be invoiced at
the full agreed to price for the completed assembly.
For assembly requirements canceled outside the manufacturing lead time of the
scheduled delivery date, Customer's liability to Plexus will be the value of the
components in Plexus' inventory (including the full markup as defined in the
Plexus quotation), and other components for which Plexus has liability but which
are not in Plexus inventory, as well as payment for any and all work-in-process
(WIP) manufacturing costs and expenses, and reasonable administrative costs and
expenses. Plexus will deliver an itemized list of these costs to customer.
Customer agrees to pay the costs identified by Plexus within ten (10) business
days of notification of such costs.
To help minimize the impact of cancellation charges, Plexus will attempt to
restock components at the supplier, resell the components, and/or utilize the
components on non-customer assemblies.
3. PAYMENT
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As full compensation for the assemblies and spare parts (i.e. to include but not
limited to components shipped to Customer for field service) provided by Plexus
hereunder and its obligations contained herein. Customer will make payments
subject to terms of net amount due thirty (30) days following the date of the
invoice. Unless stated otherwise, prices quoted are F.O.B. Plexus' manufacturing
facility. Unless specifically stated otherwise, all quoted prices are firm for
thirty (30) days from the date of quotation. Quotations are based on drawings,
specifications, and other written information available to Plexus at the time of
quotation. Any additional data supplied at the time of purchase may necessitate
price adjustments. Any manufacturer's tax, retailer's occupation tax, use tax,
sales tax, excise tax, or tax of any nature whatsoever imposed on or measured by
the transaction between Plexus and Customer shall be paid by the Customer in
addition to the prices quoted or invoiced. In the event Plexus is required to
pay such tax, the Customer shall reimburse Plexus therefore, within ten (10)
days of written demand by Plexus to the Customer for such reimbursement. If the
transaction between Plexus and the Customer is exempt from all such taxes,
Customer shall provide Plexus with a tax exemption certification or other
document acceptable to all taxing authorities at the time the order or contract
is submitted.
4. WARRANTY
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PLEXUS EXPRESSLY WARRANTS THE WORK AS SET FORTH HEREIN. PLEXUS MAKES NO OTHER
WARRANTIES, EITHER EXPRESS OR IMPLIED (INCLUDING WITHOUT LIMITATION WARRANTIES
AS TO MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSES). IN ADDITION, THE
FOLLOWING SHALL CONSTITUTE THE EXCLUSIVE REMEDIES FOR CUSTOMER FOR ANY BREACH BY
PLEXUS OF ITS WARRANTIES HEREUNDER.
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Plexus warrants the assemblies against all defects in workmanship where the
assemblies do not conform to the agreed upon manufacturing specifications, for a
period of twelve (12) months from date of delivery to Customer's end-user, not
to exceed 16 months from date of invoice from Plexus, provided agreed upon
testing is conducted by Plexus prior to shipment, except as set forth below.
Plexus shall repair or replace, at Plexus' option and free of charge, any
portion of the assemblies which is returned to Plexus' factory securely
packaged, insured and with freight pre-paid within the warranty period, and
which upon examination Plexus determines in its sole discretion to be defective
in workmanship. Plexus will return the repaired or replaced assemblies to
customer with freight pre-paid. Plexus will pay for inbound freight for any new
units delivered dead on arrival (DOA) to Customer. DOA is defined as any product
that does not perform in compliance with the applicable mutually agreed upon
specifications upon receipt by Customer. Plexus agrees to pay return freight to
Customer and method of shipment will be consistent with the method of inbound
freight to Plexus.
This Warranty does not apply to:
a) Design deficiencies. Plexus expressly disclaims any warranty
responsibility for design deficiency, and for infringement for the like.
b) Any modifications and/or alterations made to the Assemblies, or any portion
thereof, without the express written authorization of Plexus obtained in
advance. If this is the case, all warranties made herein are invalid and
Customer shall have no further remedies hereunder against Plexus.
c) Any defect, loss or damage resulting from theft, loss, fire, misuse, abuse,
negligence, vandalism, acts of God, accident, casualty, power failures or
surges, alteration, modification or failure to follow installation, operation or
maintenance instructions, or any other cause beyond Plexus' reasonable control.
d) Any defect, unless written notice of the defect is given by the Customer to
Plexus as soon as practical after the defect first appears. The right to make a
claim under this warranty expires twelve (12) months from the date of delivery
to Customer's end-user, not to exceed 16 months from date of invoice from
Plexus.
e) Components incorporated into the assemblies.
In the event of any recall of any Product, caused by Plexus's sole negligence,
and within product warranty as defined, (i) Plexus shall repair or replace, at
Plexus' sole discretion, the recalled Product without charge to Customer, and
(ii) Plexus shall reimburse Customer for its reasonable out-of-pocket expenses
incurred in connection with such recall up to a maximum of $100,000.
IN NO EVENT, REGARDLESS OF CAUSE, SHALL EITHER PARTY BE LIABLE FOR INCIDENTAL,
INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES OR LOSSES OF ANY KIND, WHETHER IN
CONTRACT OR IN TORT, ARISING FROM ITS PERFORMANCE UNDER THIS SECTION.
5. TEST EQUIPMENT
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*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Unless otherwise noted, any test equipment quoted herein and built by Plexus is
warranted to be free from defects in material and workmanship for a period of
ninety (90) days from the date of certification. After the warranty period the
equipment will be repaired on a time and materials basis. Labor will be charged
at the current billing rate. Parts will be charged at cost plus 25%. Travel
expenses will be added to any repairs including travel between Plexus and/or one
of its affiliates. All dedicated test/burn in fixtures will be progress billed
monthly up to 95% of the program cost. The remaining 5% is due upon fixture
certification.
6. DOCUMENTATION
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Unless Plexus is or has generated the documentation for the Customer as part of
its services to the Customer, then the Customer is responsible for supplying
Plexus with complete documentation. This includes, at a minimum, (three) 3
complete and current sets of documentation including, at a minimum, all prints,
softwares, artwork, and xxxx of materials with manufacturer and part number, and
any specifications, including test specializations or procedure, called for on
any customer prints. It is the Customer's responsibility to assure that Plexus
receives timely notification of any changes to the documentation, and updated
prints reflecting the changes.
7. TOOLING
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All tooling produced or obtained for the assemblies delivered hereunder and paid
for by Customer shall become and remain the property of Customer at the time
payment in full is received for the tooling by Plexus. Such tooling shall be
used by Plexus only for the benefit of Customer, and shall be delivered to
Customer upon request. If Customer requests the return of any tooling from
Plexus and Plexus determines the return of such tooling prevents Plexus from
providing the assemblies to Customer, then Plexus shall inform Customer in
writing, and Customer and Plexus shall negotiate a mutually acceptable
resolution.
Customer, at its sole discretion, may consign to Plexus, items, including, but
not limited to, materials and/or equipment relating to the production and/or
testing of the assemblies at Plexus' location. The material and/or equipment
shall be utilized by Plexus only for the production and/or testing of the
assemblies. Customer shall assist Plexus in installing the materials and/or
equipment and shall provide training and maintenance instructions, if requested
by Plexus or required by Customer. Customer shall be responsible for repairing,
upgrading, replacing and/or maintaining the materials and/or equipment consigned
to Plexus. However, Plexus shall provide routine maintenance.
8. TERMINATION AND CANCELLATION OF MANUFACTURING PHASE
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During the Manufacturing Phase, either party shall have the right to terminate
any or all activities under this agreement for any reason and at any time upon
six (6) months prior written notice to the other party. Plexus agrees to
immediately terminate the specified activity pursuant to this Agreement upon
termination or cancellation. If this entire Agreement is terminated, Plexus
shall complete all existing Customer POs as specified below unless otherwise
specified by Customer. Customer agrees to reimburse Plexus for reasonable and
allowable expenses directly incurred by
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Plexus including, but not limited to, packaging and related transportation costs
and expenses, and the return to Customer of any Customer owned material(s),
tools, equipment and/or any other related items, consistent with Section A2
Cancellation, above. Customer and Plexus shall negotiate a settlement of any
other reasonable and allowable expenses directly incurred by Plexus.
If this entire agreement is terminated, then Plexus shall:
a) Deliver to Customer all completed assemblies which conform to the
applicable and then current specifications and requirements; and
b) Return to Customer, at Customer's expense, all tooling, equipment,
Components and/or Long Lead Time Components, drawings, specifications,
documentations and supplies that are owned by Customer pursuant to the Agreement
(in the event of Plexus' material breach and the failure of Plexus to cure such
breach 60 days after receiving written notice thereof from Customer then Plexus
shall pay for freight costs associated with returning all tooling, equipment,
Components and/or Long Lead Time Components, drawings, specifications,
documentations and supplies that are owned by Customer pursuant to the
Agreement); and
c) Prepare and submit to Customer an itemized document to include the quantity
of assemblies in the production process.
Plexus shall complete and customer agrees to pay for any work in process and
open purchase orders if so requested by Customer as if no termination notice was
given. Customer further agrees to pay for all material ordered in accordance
with Section A2 above or as otherwise authorized in writing by Customer.
B. MEDICAL DEVICE PROVISIONS
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The terms and conditions set forth in this Section B, Medical Device Provisions,
Section A, Manufacturing Phase, as well as the terms and conditions set forth in
Section C, Standard Terms and Conditions, shall be applicable to this portion of
the Agreement.
Engineering Phase:
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1. Plexus shall be in substantial compliance with design controls as defined
by its product development medical device quality procedures for the device
designs covered by this contract. Plexus responsibilities under these provisions
include:
a) contributions to the Device History File (DHF) shall be limited to those
items identified in the deliverables section of the project Proposal and/or
Project Plan;
b) Contributions to the Design Master Record (DMR) shall be limited to those
items identified in the deliverables section of the project Proposal and/or
Project Plan;
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
c) Maintenance of quality system quality records, as defined by Plexus
Technology Group's Document Retention Chart, (e.g., Internal Audit Results, QIP
database, Supplier Records, Management Review Meeting Records, etc.) which are
not provided to the customer.
2. Customer is responsible for identifying all applicable laws and
regulations, including the Food, Drug and Cosmetic Act, and compliance with
those regulations for all devices covered by this contract.
Manufacturing Phase:
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1. Customer is responsible for ensuring that the devices covered by this
contract comply with all applicable laws and regulations, including the Food,
Drug and Cosmetic Act and implementing regulations. Customer responsibilities
under these provisions, include but are not limited to the following:
a) Establishing the finished device specifications.
b) Ensuring that governmentally-required marketing authorizations, including
any necessary Food and Drug Administration (FDA) approvals or clearances, have
been obtained.
c) Determining the content of any label or labeling.
d) Making any required reports to governmental entities, including but not
limited to Medical Device Reports.
e) Determining whether any recall or other corrective action is required or
appropriate, and developing, implementing and financing any voluntary or
mandatory recall or corrective action.
f) Reviewing and approving the quality system prior to production of the
devices.
2. Plexus will provide Customer ongoing access to its facilities and
procedures for quality assurance related to the devices covered by this
contract. Plexus authorizes Customer to conduct periodic quality systems audits
of the manufacturing processes and quality systems related to this contract.
Plexus will manufacture the devices covered by this contract in accordance with
its procedures for manufacturing components of medical devices or finished
medical devices, as applicable.
3. Customer will provide Plexus with sufficient information to verify,
calibrate, operate, test and maintain any Customer supplied equipment.
4. Customer shall be responsible for the software validation of any embedded
product software and the validation of all Customer supplied: (1) test equipment
or test software; (2) production equipment or software; and (3) firmware. Plexus
is responsible for the validation of any Plexus software used in production in,
or as part of the Quality System. The responsibilities described in this section
also apply to any revisions of any software.
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
5. The Customer will provide Plexus with copies of the specifications and
written certification that the validation reports for the items listed in
Section #4 above have been performed prior to the production of the devices.
6. Customer is responsible for defining and validating the finished device
packaging. The Customer will provide Plexus with written certification that the
packaging validation has been performed prior to the production of the devices.
7. Plexus is responsible for conducting and documenting corrective and
preventive actions based upon the analysis of the quality data available to
Plexus. Quality data or information known to the Customer, but not provided to
Plexus, shall not be included in the analysis of quality data, and the Customer
shall be responsible for the analysis of data not provided to Plexus.
8. Any Customer initiated request for change to a specification, method,
process or procedure or customer supplied equipment will be evaluated by Plexus,
and Plexus reserves the right to decline to make such change. Customer is
responsible for verification and/or validation of such changes. Customer shall
reimburse Plexus for any costs Plexus incurs in making and/or implementing such
changes.
9. Plexus shall notify Customer of significant changes in specifications,
methods, processes or procedures that could affect the quality of the devices
covered by this contract, and, as to any such change, Customer and Plexus shall
decide jointly whether, how and when to implement such change, and who shall be
responsible for verification and/or validation of such changes. Customer and
Plexus shall also decide jointly who will be responsible for the costs
associated with such changes.
10. The Customer must define any traceability requirements. Plexus is
responsible for implementing the defined manufacturing level traceability
requirements and for ensuring that the appropriate manufacturing level
traceability records and associated records are retained for the duration of the
contract.
11. Unless otherwise specified in the contract, Plexus is not responsible for
ensuring traceability of the devices covered by this contract after distribution
to the end user(s).
12. Plexus is responsible for retaining the appropriate manufacturing records
as required. When the contract between Plexus and the Customer terminates,
Plexus shall forward all applicable documentation and records to the Customer,
upon request.
13. Customer may authorize in writing the release of nonconforming components
or devices covered by this contract. The Customer must assess whether the use of
the nonconforming product will affect any regulatory submittals or requirements,
and accept responsibility therefore.
14. Customer will promptly provide to Plexus copies of all complaints received
by Customer that refer or relate to an assembly manufactured by Plexus and all
adverse event reports to a governmental entity that refer or relate to an
assembly manufactured by Plexus. Plexus will
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
provide to Customer information regarding any complaints Plexus receives about
the product in which the devices covered by this contract are incorporated.
15. Sections C.(5) and C.(7) "Liability and Indemnification" & "Compliance with
Regulations and Standards", respectively, both a part of Section C "Standard
Terms and Conditions" of this Agreement is further supplemented to provide that
the indemnification of Plexus will further cover Customers' failure to comply
with applicable laws and regulations, including but not limited to the Food,
Drug and Cosmetic Act and implementing regulations.
C. STANDARD TERMS AND CONDITIONS
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The terms and conditions set forth in this Section C, STANDARD TERMS AND
CONDITIONS shall be applicable to Section A, Manufacturing Phase, as well as the
terms and conditions set forth in Section B, Medical Device Provisions of this
Agreement.
1. MUTUAL COOPERATION
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Plexus represents that it will pursue the Agreement to the best of its ability
and in the best interest of the Customer, and the Customer represents that it
will cooperate with Plexus in reaching the objectives of the Agreement. Plexus
will appoint a project manager for the duration of the Agreement and will
require the Customer to establish one person to coordinate all activities
through. In the event that the project manager is not operating in the best
interest of the Customer, the Customer shall contact Plexus to discuss Agreement
related concerns and/or complaints.
2. CONFIDENTIAL INFORMATION
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Plexus and the Customer will use best efforts to prevent the disclosure of any
confidential information, unless specifically instructed otherwise in writing by
the disclosing party, and excepting in such instances where Plexus may be
compelled by law to make disclosures. The mechanisms for controlling and
processing confidential information may be covered under a separate Confidential
Disclosure Agreement (if required).
3. FORCE MAJEURE
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Plexus shall not be liable for any delay in or failure of performance under this
agreement due to any contingency beyond Plexus' control, including, but not
limited to, an act of God, war, insurrection, fire, riot, strike or labor
dispute, sabotage, act of public enemy, flood, storm, accident, equipment
failure, inability to obtain suitable or sufficient labor or material, laws or
regulations, or any other cause beyond its reasonable control.
4. INTELLECTUAL PROPERTY RIGHTS
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All patents, copyrights, trademarks, or other rights pertaining to inventions,
developments, or improvements made in the course of the work, and funded by the
Customer, are the property of Customer. Plexus will, upon written direction from
Customer, execute any and all papers and documents prepared or submitted by
Customer as may be reasonably required to transfer or
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
secure to Customer full title and authority over such rights. Plexus will be
compensated by Customer for time and expense as incurred in this obligation at
the then current billing rates for those of its employees necessary for these
purposes.
Customer agrees that it shall assume all responsibility for determining whether
the assemblies to be designed and assembled infringe on any patent, copyright or
trademark, and Customer shall indemnify and hold harmless Plexus from any
liability, including legal costs and expenses, damages and attorney fees arising
from any claim demand or suit, including a claim by Customer, based on
allegations or claims that the assemblies or any design, patent, copyright, or
trademark sought to be obtained or obtained by Customer as a result of this
agreement constitutes an infringement of any patent, trademark or copyright of
the United States or any foreign county.
In the event any such claim or suit is asserted or instituted against Plexus,
Plexus shall promptly notify Customer of the assertion of any such allegation or
claim. Customer shall thereupon assume responsibility for and conduct the
defense of each assertion or suit at its expense, and reasonable information and
assistance for the defense of same shall be provided by Plexus for which Plexus
will be compensated for time and expenses at its then current billing rate.
Plexus shall have the right, at its expense, to be represented in the defense of
any such assertion or suit by counsel of its own selection.
The prices quoted do not include, unless specifically stated otherwise, the cost
for testing and/or submittals for assembly approvals or any annual file
maintenance fee, such as for UL, VDE, CSA or FCC. Plexus will assist Customer in
obtaining such approvals and charge for same services at Plexus' current hourly
billing rate.
5. LIABILITY AND INDEMNIFICATION
----------------------------------
Plexus will use its discretion to pursue the Agreement in the best interest of
Customer. Plexus will be under no liability to Customer or otherwise for its
choice of methods employed, the character or tests and experiments performed,
the results obtained, nor for the use which shall thereafter be made by Customer
of such results. IT IS UNDERSTOOD THAT OTHER THAN THE WARRANTY SET FORTH IN
SECTION A4, NO OTHER GUARANTEES OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
ARE GIVEN BY PLEXUS, INCLUDING, BUT NOT LIMITED TO ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. PLEXUS SHALL NOT BE LIABLE
FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS)
SUSTAINED OR INCURRED IN CONNECTION WITH THIS AGREEMENT.
Customer will fully indemnify and hold harmless Plexus from any and all
liability, claims demands, costs and expense arising out of the use,
publication, and/or marketing of the results of the assemblies or test results
provided by Plexus, the functioning of the assemblies or the product(s) which
they are a part of, or any other matter resulting from Plexus' performance under
this Agreement, whether such liability, claims or demands be in the nature of
patent, trademark or copyright infringement, public or product liability,
contract liability, or otherwise during or following the terms of this
Agreement, and Customer shall, at its own expense, defend any and
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
all such actions based thereon and shall pay all attorney's fees and cost and
other expenses arising therefrom.
Plexus will not be liable for errors, or expenses which may be incurred in its
performance of this work which results from the engineering and/or design of the
Assemblies, or from Plexus' reliance upon information, technological records,
sketches, drawings, or prototypes furnished by Customer or Customer's design
engineering firm. Customer will forthwith, during the term of this Agreement,
notify Plexus of any and all information, technology changes, or other facts
relevant to any aspect or phase of the Agreement.
6. ARBITRATION
----------------
All rights and remedies conferred by this Agreement, by any other instrument, or
by law are cumulative and may be exercised singularly or concurrently. If any
provision of this Agreement is held by any court or governmental agency to be
invalid, such invalidity shall not affect the enforceability of any other
provision(s) hereof. This Agreement and any Purchase Orders issued hereunder
shall be governed by and interpreted in accordance with the laws of the State of
Wisconsin. Unless otherwise agreed to in writing by the parties, any controversy
or claim arising out or relating to this Agreement, or the parties' decision to
enter into this Agreement, or the breach thereof, shall be settled by
arbitration through the American Arbitration Association and in accordance with
the Commercial Arbitration Rules of the American Arbitration Association. The
arbitration proceeding shall be conducted and presided over by a single neutral
arbitrator chosen pursuant to American Arbitration Association procedures.
Decision of the arbitrator shall be final, binding, and not subject to appeal or
review; provided that, either party may request that the arbitrator review and
reconsider his or her decision, in whole or in part. Judgment upon the award
rendered by the arbitrator may be entered in any court having jurisdiction
thereof. The arbitration shall be held in Neenah, Wisconsin and the arbitrator
shall apply the substantive law of Wisconsin except that the interpretation and
enforcement of this arbitration provision shall be governed by the federal
Arbitration Act. The arbitrator shall not award either party punitive damages
and the parties shall be deemed to have waived any right to such damages.
7. CONSENT TO JURISDICTION AND APPLICABLE LAW
-----------------------------------------------
The parties hereby irrevocably submit to the jurisdiction of the courts of the
State of Wisconsin in any action or proceeding arising out of or relating to
this Agreement, and the parties hereby irrevocably agree that all claims in
respect of such action or proceeding may be determined by such courts. The
parties hereby waive, to the fullest extent possible, the defense of an
inconvenient forum to the maintenance of such action or proceeding, and the
parties agree that a final judgement in any action or proceeding shall be
conclusive and may be enforced in other jurisdictions by suit on the judgement
or in any other matter provided by law.
The parties hereby agree that this Agreement shall be governed by and will be
construed in accordance with the laws of the State of Wisconsin, irrespective of
the conflicts of laws provisions thereof.
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
8. NO RECRUITING
------------------
Plexus and the Customer agree that during the term of this program and for
twelve (12) months thereafter, it shall not solicit or recruit (even though
professional recruiters) the employees of the other. This shall not preclude an
employee of either Plexus or the Customer from independently pursuing and
securing employment opportunities with the other on such employee's own
initiative.
9. ENTIRE AGREEMENT
---------------------
This Agreement, along with the Proposal and/or Project Plan, and Confidential
Disclosure Agreement and/or quotation (if any) and Plexus' invoices, contains
the entire understanding of the parities pertaining to the subject matter
hereof, and no other agreements, oral or otherwise, shall be deemed to exist or
to bind the parties. Notwithstanding anything to the contrary contained herein,
the parties hereto agree that the terms and conditions set forth herein and in
Plexus' invoices, Proposal and/or Project Plan and Confidential Disclosure
Agreement (if any), shall supersede any and all terms and conditions submitted
by the Customer in any document, including but not limited to any terms and
conditions contained in the Customer's purchase order. This agreement may not be
modified or terminated orally, and no claimed modification, termination, or
waiver shall be binding unless in writing and signed by both parties.
Accepted and agreed to:
XXXX MEDICAL SYSTEMS, INC. PLEXUS CORP.
ENGINEERING AUTHORIZATION:
By: /s/ Xxxxx Xxxxxxx By: /s/
---------------------------------------- -------------------------------------
Title: President and Chief Financial Officer Title: Vice President of Engineering
------------------------------------- ----------------------------------
Date: February 24, 2000 Date: February 17, 2000
-------------------------------------- -----------------------------------
MANUFACTURING AUTHORIZATION:
By: /s/ Xxx Xxxx
-------------------------------------
Title: Vice President and General Manager
----------------------------------
Date: February 17, 2000
-----------------------------------
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Attachments to Professional Services Agreement
Attachment A Document Change Control Agreement
Attachment B Project Plan (subject to revision upon mutual agreement)
Attachment C Unit Cost Calculation to be used for Planning Purposes
Attachment D Specification (subject to revision upon mutual agreement)
*** Material has been omitted pursuant to a request for confidential treatment
and such material has been filed separately with the SEC.
Attachment A
Attachment A
DOCUMENT CHANGE CONTROL AGREEMENT
between SeaMED, a Plexus Company and Xxxx Medical Systems, Inc.
for Project Red Butte
February 17, 2000
1. Purpose and scope of this agreement.
1.1. The objective of this agreement is to define the document change
control process for documents involved in SeaMED's manufacture of
devices for Xxxx Medical Systems, Inc.
1.2. It is a goal of this agreement that there be only one document and
one point of change control for each item and/or document. Since
SeaMED is the manufacturer and purchaser of the device's component
parts, engineering change control for all related documentation will
reside at SeaMED. To ensure uniform document content, Xxxx Medical
Systems, Inc. should release only the SeaMED-supplied version of any
document, in those cases where both companies release a document.
Changes should be made by the terms of this agreement.
1.3. SeaMED will administer change control in accordance with SeaMED
Document Change Procedure (Document # 900319), including determination
of change classes as described below.
1.4. This agreement affects all documents in the Device Master Record
Index of products at Production-level release that SeaMED manufactures
for Xxxx Medical Systems, Inc.
2. Document Change Procedure. This procedure defines the classes of changes
and the mechanics of the change process based on those classifications per
SeaMED's internal Quality Assurance requirements.
2.1 Document classifications: Documents may be described as either
common or product-specific. The common category includes Source and
Specification Control Drawings (SCD) used for buying and inspecting
commercially available, "off-the-shelf" parts. Product-specific
documents include all documents that are unique to the design of the
product.
2.2. Document Change Classifications: Change Class defines the impact of
the change. Where the term "form, fit, or function" is used, the
meaning includes: specifications/limits/dimensions, regulatory
compliance, appearance, cosmetic criteria, manufacturing or test
processes, design verification test status, increase in manufacturing
costs, and scheduled shipping dates. A DCN may have changes from more
than one change class; the change class for the DCN as a whole shall
be that of the highest level on the DCN. The classes are defined as
follows:
2.2.1. Class 0: Changes to SeaMED procedures, common parts and any
documents without a project name in the title. Class 0 changes
do not fit within the definition of Class 1, 2 or 3 changes.
Class 0 changes are not design changes.
Class 0 changes do not require customer approval or
notification.
2.2.2. Class 1: Changes to product-specific or common parts documents
where there is no impact on component or assembly form, fit,
---------
or function. Class 1 changes are not design changes. Class 1
changes are typically documentation corrections and
clarifications. Class 1 changes do not require customer
approval, but do require customer notification within one (1)
working day after approval by SeaMED.
2.2.3. Class 2: Changes to product-specific or common parts documents
where there is no intended impact on end-item form, fit, or
------------------
function, but an element (document, part, process, etc.) of
the established baseline is changing. Class 2 changes are
design changes and require justification. Class 2 changes are
typically physical changes to a part or assembly's dimensions,
manufacturing process, or test process. Class 2 changes
require customer approval.
2.2.4. Class 3: Changes to a product-specific document where there is
impact on end-item form, fit, or function. Class 3 changes are
------
design changes and require justification. Class 3 changes are
typically due to unit performance improvements, unit
packaging, physical configuration changes, etc. Class 3
changes require customer approval.
3. Mechanics of the change process.
3.1. It is a goal of this agreement that all correspondence regarding
document changes be handled promptly and speedily. Delays can
seriously upset scheduled buys, work orders, and shipments.
3.2. SeaMED Documentation Control will handle all correspondence for
SeaMED regarding document changes.
3.3. SeaMED will notify Xxxx Medical Systems, Inc. by telefax of Class 1
changes as they are signed and implemented.
3.4. SeaMED will submit Class 2 and 3 changes to Xxxx Medical Systems,
Inc. by telefax for approval after SeaMED's Change Control Board has
approved the proposed change.
3.5. Xxxx Medical Systems, Inc. will designate one representative and one
alternate with authority to approve/disapprove proposed changes as
they are presented by SeaMED. Proposed changes should be addressed
within one week.
3.6. Xxxx Medical Systems, Inc. may request a change to any document,
common or product-specific, by submitting a written change request.
Change requests are to be signed by the designated Xxxx Medical
Systems, Inc. representative, or their alternate, with the authority
to approve/disapprove the request. SeaMED should address requested
changes in one week or less.
3.7. SeaMED will periodically provide copies of all incorporated changes
to product specific documents.
4. Costs associated with document changes.
4.1. A certain number of changes is normal during the life of a product.
Also, once production is underway, SeaMED or Xxxx Medical Systems,
Inc. may suggest changes to ease manufacture or inspection. SeaMED
may elect to waive the administrative costs associated with these
changes.
4.2. Changes which occur at Xxxx Medical Systems, Inc. request, regarding
the established design of the product or affecting parts already
ordered or in SeaMED's inventory, will be considered individually. In
some cases, an administrative charge may be assessed by SeaMED for the
cost of processing and incorporating a change aside from any material
costs involved.
Agreed to, for Xxxx Medical Systems, Inc., by on
_______________ _____________
Agreed to, for SeaMED, a Plexus Company, by on
Documentation Control _______________ _____________
Project Director _______________ on _____________
Attachment A
Designated Representatives
Xxxx Medical Systems, Inc. designated representatives with authority to
approve/disapprove proposed changes. Xxxx Medical Systems, Inc. is responsible
for providing SeaMED with updated names of designated representatives.
Name (printed) Signature Initial
-------------- ---------
Representative -------------------- -------------------- ---------
Alternate -------------------- -------------------- ---------
SeaMED
------
A PLEXUS.Compuny
PROJECT PLAN, REDBUTTE
Drawing Number
950053
Revision
P1
REVISION HISTORY
--------------------------------------------------------------------------------------------------------------
Rev Change Number/Description Date Change Originator Incorp by Chkr
--------------------------------------------------------------------------------------------------------------
P1 Initial Release 1/31/00 X. Xxxxxxx- - - - -
--------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------
1. PURPOSE
This document outlines the content of Project RedButte. This document
further defines how SeaMED will meet the objectives set out in the Quotation
sent to Xxxx Medical Systems Janury 12, 2000 for the manufacturing transfer
of the Xxxx model 1500 RF ablation system.
2. SCOPE
This document is the defining document for how the RedButte project is
planned at SeaMED and is used to manage and track the progress of the
project. The Project Plan is reviewed as part of a Phase Ending Design
Review. The Project Plan is one deliverable during the planning phase of a
project as defined in the SeaMED Product Development Procedure, 902148.
3. SIGNATURE PAGE
Project signing block
Example
-------------------------------------------------------------------------------------------------
Role Name Signature Date
-------------------------------------------------------------------------------------------------
Project Director Xxxxxx Xxxxxxx
-------------------------------------------------------------------------------------------------
Quality Systems Xxxxxxxxx Xxxxx
Manager
-------------------------------------------------------------------------------------------------
Director of Project Xxxx Xxxxx
Management
-------------------------------------------------------------------------------------------------
VP of Quality of Xxxxxx Page
Regulatory Affairs
-------------------------------------------------------------------------------------------------
Manufacturing Xxxx Xxxx
Engineering
-------------------------------------------------------------------------------------------------
Quality Engineering Xxxxx Xxxxxx
-------------------------------------------------------------------------------------------------
Test Engineering Xxxxx Xxxxxxxx
-------------------------------------------------------------------------------------------------
Materials Xxxxxxx Xxxxxx
-------------------------------------------------------------------------------------------------
Customer - Program Zia Yassinzadeh
Manager
-------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------
3.1. Customer Team Members
. Xxxx Medical Systems, Inc.
000 X. Xxxxxxxxx Xxxx.
Xxxxxxxx Xxxx, XX 00000
Telephone: (000) 000-0000
Fax: (000) 000-0000
. Zia Yassinzadeh, Program Manger, Director, Electrical Engineering
. Xxx Xxxxxxx, Vice-President, Operations
. Xxx Xxxxxxxx, Vice-President, Research and Development
TABLE OF CONTENTS
1. PURPOSE 3
2. SCOPE 3
3. SIGNATURE PAGE 3
3.1. PROJECT SIGNING BLOCK (INCLUDING CUSTOMER SIGNATORIES) 3
3.2. NON SIGNING CUSTOMER TEAM MEMBERS 4
4. TABLE OF CONTENTS 5
5. REFERENCE DOCUMENTS - INCLUDE BOTH INTERNAL AND EXTERNAL 7
6. EXECUTIVE SUMMARY 7
6.1. PRODuCT DESCRIPTION 7
6.2. DESCRIPTION OF PROJECT NAME 8
6.3. SEAMED'S ROLE IN THE PROJECT 8
6.4. RITA'S ROLE IN THE PROJECT 9
6.6. SCHEDULE OVERVIEW 9
6.7. FINANCIAL OVERVIEW 10
7. REGULATORY AND SAFETY AGENCY APPROACH 10
7.1. PRODUCT CLASS DESIGNATION 10
7.1.1. FDA-21 CFR Ch. 1(4-1-87 Edition) Part 820-Good Manufacturing Practices 10
7.1.2. EC-Medical Device Directive (MDD) 93/42/EEC of 14 June 1993 11
7.2. REGULATORY APPROACH - DOMESTICE AND EUROPEAN/INTERNATIONAL 11
7.3. SAFETY AGENCY APPROACH 11
8. ADMINISTRATION OF PROJECT 11
8.1. TEAM ORGANIZATION AND RESPONSIBILITIES 11
8.2. TEAM MEETINGS 12
8.3. COMMUNICATION (POINTS OF CONTACT) 12
8.4. PROJECT NOTEBOOK 12
8.4.1. Project Notebook 12
8.5. DESIGN HISTORY FILE 13
8.5.1. Purpose and Contents 13
8.6. DETAILED PROJECT SCHEDULE 13
8.6.1. Project Phases 13
8.6.2. Key Milestones 15
8.7. ASSUMPTIONS 15
8.8. APPROVALS AND CUSTOMER DELIVERABLES 16
8.8.1. Customer Approvals Required 16
8.8.2. SeaMED Executive Approval Required 16
8.8.3. Signature Authority 16
8.8.4. Customer Deliverables 16
8.8.5. Summary of Unit Allocation and Pricing 16
8.9. DESIGN REVIEWS 17
8.10. CHANGES TO PROJECT - I.E. SCOPE, SPEC, SCHEDULE, RESPONSIBILITY, ETC 17
8.10.1. Minor 17
8.10.2. Major 18
8.11. TRANSFER TO PRODUCTION AND PROJECT CLOSURE 18
9. FINANCE 18
9.1. BUDGETS 18
9.2. COST OF XXXXX 00
XXXXXXXXXXX
XXXXXXXX A - SCOPE I SPECIFICATION CHANGE REQUEST FORM 00
XXXXXXXX X - MASTER SCHEDULE 19
APPENDIX C - PROJECT MATERIAL PLAN 21
APPENDIX D - PROJECT QUOTATION, JANUARY 12, 2000 22
5. REFERENCE DOCUMENTS - INCLUDE BOTH INTERNAL AND EXTERNAL
This section contains a listing of all internal SeaMED Procedures and
external documents referenced in the Project Plan, including safety agency
and regulatory standards, directives or documents.
. SeaMED Document Change Procedure 900319
. SeaMED Documentation Control Operations Manual 908608
. SeaMED Product Requirements Specification, RedButte TBD
. Manufacturing Plan, RedButte 950056
. Manufacturing Test Plan, RedButte 950047
. SeaMED Product Development Procedure 902148
. SeaMED Design Review Procedure 915005
. Service Plan, RedButte TBD
. UL 2601-1
. CSA C22.22 No.60101
. EN 60601-1/IEC 601-1
6. EXECUTIVE SUMMARY
The RedButte project is a Manufacturing transfer project of the Xxxx Model
1500 ablation system from Apical to SeaMED. This project will be conducted
in accordance with SeaMED Product Development Procedure (SeaMED dwg.
#902148)
The NRE work is described in the Quote sent to Xxxx January 12, 2000, which
is attached as Appendix D.
SeaMED will transfer the Xxxx design into Manufacturing at SeaMED. Design
responsibilty for the product resides with Xxxx. SeaMED will not create a
Design History File nor conduct a Hazard Analysis. Thse are understood to
be responsibilities of Xxxx. SeaMED will not conduct Design Verification
Testing. Xxxx is responsible for conducting "correlation" testing to make
sure the product has been transferred without violating the Product
Specifications.
6.1. Product Description
The customer is Xxxx Medical Systems Inc., located in Mountain View,
California.
The product is the Xxxx Model 1500 RF Generator. The product is an
electro-surgical cutting and coagulation device, which generates RF
energy for the ablation of soft tissue.
The product includes a sheet metal enclosure, plastic bezel, overlay,
7 PCBAs, custom magnetics, power supply, 9 wire harnesses, footswitch,
detachable power cord, and a disposable probe.
This product is an evolution of an earlier model device. Both it and
its predecessor have been manufactured previously by Apical.
6.2. Description of project name
SeaMED traditionally names its projects after a Washington state mountain
peak which has the same first letter as the name of the customer. The name
chosen for this project is Red Butte, elevation 7,208 feet, in the North
Cascades of Washington State.
6.3. SeaMED's Role in the Project
. SeaMED has been hired to manufacture the Model 1500 RF ablation device
for Xxxx Medical Systems. SeaMED will transfer the design from Xxxx to
SeaMED.
. SeaMED will not be doing electrical or mechanical design. There is no
software development on SeaMED's part.
. Primary SeaMED activities described later in this Project plan include:
SeaMED Project Planning, including a Project Plan (This is a non-
billable activity), Project Schedule, Manufacturing Plan, Manufacturing
Test Plan, and Manufacturing Test specifications.
Documentation Transfer of Xxxx drawings.
Review and audit Xxxx BOM dated 11/29/99 to physical samples provided
by Xxxx to correct any BOM errors prior to loading BOM into SeaMED MRP
System, Proteus.
Document 9 Wire Harnesses from BOM and Physical sample provided by Xxxx
Medical.
Create source control drawings for parts that are not currently
documented at SeaMED.
Release Xxxx drawings in SeaMED's system in order to procure, inspect,
and stock parts for manufacturing.
Create a Final Assembly Drawing with instructions that SeaMED can use
to build the device.
Generate the Xxxx of Material in MRP to structure material procurement
and the manufacturing process in the most efficient manner.
Create and release a Process FMEA (This is a non-billable activity)
Develop Manufacturing Test procedures to test the model 1500 in
manufacturing:
Design and build a Golden Board Test Fixture (GBTF) to support board
level test, calibration and debugging of individual PCBAs. This
fixture will also be used to provide in/out of house service boards.
Design and build a System Test Fixture, a QA Final Test Fixture and a
Run-In Test Fixture.
Make layout modifications of the Display PCBA as requested by Xxxx to
remove switches and obsolete traces, eliminate interference between
PCB and connectors, trim/notch PCB top and bottom, add 11 position
single row ribbon cable locking connector, and eliminate extra
mounting holes not needed.
Provide input for Xxxx Run-In test code to be developed by Xxxx.
. SeaMED will not be responsible for performing clinical research,
submitting FDA applications, providing repair services in the field, or
providing marketing and sales services.
. SeaMED will not be performing Design Verification Testing to verify the
product meets the Device Specifications.
. Xxxx has the responsibility for the final Design Validation.
. SeaMED can make no claims about the clinical efficacy of this product.
SeaMED's responsibility is to manufacture the device to meet the
specification document.
. SeaMED will service the product in accordance with RedButte project-
specific Service Plan, document number TBD.
6.4. Rita's Role in the Project
Xxxx is responsible for providing to SeaMED all Bills of Materials, part
drawings, schematics, and electronic files necessary to order, receive and
inspect materials. Xxxx deliverables are listed in sections 8.6, 8.7, and
8.8.4.
Xxxx is responsible for all design in the project, including providing
documented evidence to the FDA that the Product Functional Specifications
given to SeaMED are appropriate and address the intended use of the device,
including the needs of the user and the patient.
Xxxx is responsible for providing validated Run-In Test software.
Xxxx is responsible for Design History File, Design Verification and Design
Validation which proves that the product satisfies the user needs and
intended use of the device.
6.5. Schedule Overview
. The goal of this project is to transfer Xxxx documentation to SeaMED
such that first 25 Production units can be built by May 8, 2000.
. This project is managed in phases, which may overlap.
. In Phase I SeaMED will develop planning documents (Project Plan,
Materials Plan, Manufacturing Plan, and Manufacturing Test Plan).
. Phase II runs in parallel with Phase I and comprises the documentation
transfer aspect of the project - BOM transfer into the SeaMED system,
release of drawings into SeaMED, creation of wire harness assembly
drawings, as well as procurement of long-lead parts, design of test
fixtures.
. Phase III includes the procurement of materials for Production
units, creation
of Final assembly drawings, build of test fixtures, and creation
of test procedures.
. Phase IV includes verification and validation of test fixtures and
Production build of the first 25 Production units which are
subsequently tested by Xxxx as "correlation units".
. Phase V contains a Production Readiness Review at SeaMED to check
that all manufacturing issues have been addressed, and the project
is released to Manufacturing, bringing the project to closure.
. All phases have Phase-ending reviews per SeaMED's Design Review
Procedure (#915005).
. Deliverables by Phase are described in section 8.6.
. Key milestone dates are shown in section 8.6.2
. Appendix B is the RedButte Project schedule
6.6. Financial Overview
. Total NRE for the project, per the January 12, 2000 quotation was
quoted at $163,268.
. $10,518 is budgted for Test fixture materials. The remaining
$152,750 was budgeted as labor.
. On January 14, 2000, it was agreed to reduce the labor by $1575.
The new NRE totals are: $161,693 total, $151,175 labor.
. Labor to support the acitivities described in this project are
billed out at the following rates:
. Project Director $ 0
. Quality Engineer $ 0
. Manufacturing Engineer $105
. Test Engineer $105
. Material Coordinator $ 0
. Technician $ 55
. Document Tech $ 55
. PCB Designer $ 65
. Drafting $ 55
. In the event of a scope change, the billing rate for the Quality
Engineer will be $105 per hour for efforts to support the scope
change only.
. Project RedButte is a fixed price project. SeaMED will invoice
Xxxx monthly for the amount of work performed until the fixed price
limit is reached. Payments are not based on milestones.
7. REGULATORY AND SAFETY AGENCY APPROACH
7.1. Product Class Designation
7.1.1. FDA-21 CFR Ch. 1 (4-1-87 Edition) Part 820-Good Manufacturing
Practices
. The FDA classifies RedButte as a Class II medical device
SeaMED Team:
-----------
Project Director (PD) Xxxxxx Xxxxxxx
Manufacturing Engineer (MfgE) Xxxx Xxxx, Xxxx Xxxxxx
Test Engineer (TE) Xxxxx Xxxxxxxx, Xxxx Xxxx
Quality Engineer (QE) Xxxxx Xxxxxx
Document Technician (Doc Tech) Xxxxxx Xxxxxxx
Drafting (Drft) Xxx Xxxx
Materials Support
Materials Coordinator (MC) Xxxxxxx Xxxxxx
Production Control (PC) Xxxxxx Xxxxxxx
Customer Support Team
Customer Support (CS) Xxxxx Xxxxxx
8.2. Team Meetings
Project Team Meetings will be held weekly throughout the project to plan
global activities and track overall progress. This meeting is intended to
be a one hour status meeting. The Project Director is responsible for
conducting this meeting and will publish minutes, which will be distributed
to the Customer, the project team, and the Project Notebook.
If the project director is absent, either the Test Engineer or another team
member will be so designated.
Project Team Meetings will be posted in the corporate weekly schedule so
that other members of the company may attend if desired.
Even though a member may be absent from a meeting they are still
responsible for any action items or information that occurs at the meeting
they missed.
The Customer may elect to be involved in team meetings via telephone or via
on-site visits at their discretion.
8.3. Communication (Points of Contact)
Good communication between SeaMED and Xxxx is critical to the success of
the project. Essential communication between companies should pass through,
in writing via fax or E-mail, between the Project Director (Xxxxxx Xxxxxxx)
and Zia Yassinzadeh. Technical communication may pass through other points
of contact, as practical. The SeaMED Project Director and Xxxx contacts
should be apprised of important information passing through other channels.
Communication regarding unit deliveries should pass through Customer
Support (Xxxxx Xxxxxx) at SeaMED and Xxxx Xxxxxx at Xxxx.
8.4. Project Notebook
8.4.1. Project Notebook
The Project Notebook serves as a central file for project correspondence
that relates to project
administration.
All project related correspondence should be entered into the Project
Notebook. This includes meeting minutes, faxes, letters, memos, phone call
logs, notes, correspondence, etc. Documents that are formally released
under Configuration Control need not be placed into the notebook. The
author of the correspondence or a document decides who on the Project Team
receives that document.
Documents shall be filed in chronological order with an index at the front.
The Project Notebook shall be located and retained in the SeaMED Document
Control area. It is audited and maintained by Documentation Control per the
Document Control Operations Manual, 908608.
8.5. Design History File
SeaMED will not create a Design History File for this project. The
responsibility for creating and maintaining a Design History File lies with
Xxxx.
Xxxx maintains the DHF for the system design. Any design changes at SeaMED
will be processed through Document Change Notices per SeaMED Document
Change Procedure, document 900319. All design related material will be
filed in the Design History File by Xxxx.
The Design History File will be maintained by Xxxx throughout the
manufacturing phase.
8.6. Detailed Project Schedule
8.6.1. Project Phases
Phase I: Proiect Planning, SeaMED output deliverables
------------------------------------------------------
(Note: Xxxx is responsible for Design content, Design History File, Risk
Management, Verification and Validation of hardware and software.)
. Release Project Plan (PD)
. Release Manufacturing Plan (MfgE)
. Release Manufacturing Test Plan (TE)
. Transfer a Product Requirements Specification (MfgE)
. Phase I (Spec) Ending Review (PD, team)
Phase I: Proiect Planning. Xxxx input deliverables
---------------------------------------------------
. PO for NRE
. PO for production units
. Product Reuirements Specification
. Sample unit for evaluation
Phase II: Conceptual Design/Documentation Transfer, SeaMED output deliverables
-------------------------------------------------------------------------------
. Release Xxxx BOM into SeaMED MRP (MfgE)
. Transfer Xxxx drawings and schematics into SeaMED system (MfgE, Doc
Tech)
. Create wire harness assembly drawings (MfgE, Drft)
. Re-layout Display PCBA (PCB Designer)
. Create Test Specifications (TE, Xxxx)
. Design Test Fixtures (TE)
. Phase II (Paper) Ending Review (PD, team)
Phase II: Conceptual Design/Documentation Transfer, Xxxx input deliverables
----------------------------------------------------------------------------
. Xxxx BOM
. Electronic files of Xxxx drawings and schematics
. Procure Long Lead Items for first Production Build (MC)
. Mechanical requirements for Display PCBA redesign actvity
. A set of PCBAs for use as Test Fixtures
. Test specification requirements
. Packaging documentation
. Operator's Manual
Phase Ill: Prototype & Engineering Confidence Testing, SeaMED output
---------------------------------------------------------------------
deliverables
------------
(Note: there are no prototypes in this project.)
. Review and RedlineDrawings and Documents (MfgE, QE)
. Send first article custom magnetics to Xxxx for Engineering Confidence
Testing (TE, Xxxx)
. Build Test Fixtures (TE)
. Create process FMEA (MfgE)
. Finalize Pre-Prod Manufacturing Plans and Procedures (MfgE, TE)
. Phase III (Verification) Ending Review (PD, team)
Phase III: Prototype & Engineering Confidence Testing, Xxxx input deliverables
-------------------------------------------------------------------------------
. Run-in Test Software
Phase IV: PreProduction & Design Verification, SeaMED output deliverables
--------------------------------------------------------------------------
. Build 25 correlation Production Units at SeaMED (Production, MfgE)
. Verify and Validate Test Fixtures (TE)
. Verify Test Procedures (TE)
. Update Drawings as necessary (MfgE, Drft)
. Perform correlation Testing of Hardware (Xxxx)
. Support for Regulatory Submittals (QE)
. Phase IV (Final) Ending Reviews (PD, team)
Phase IV: PreProduction & Design Verification, Xxxx input deliverables
-----------------------------------------------------------------------
. Test results of custom magnetics 1st articles
Phase V: Transfer to Production, SeaMED output deliverables
--------------------------------------------------------------
. Production Readiness Review (MfgE, team)
. Build remaining Production units on 1st P.O. (Production)
Phase V: Transfer to Production, Xxxx input deliverables
-----------------------------------------------------------
. Correlation test results
. Production forecast
8.6.2. Key Milestones
. Project Start Phase I 1/00
. Phase I Design Review Phase I 2/00
. Phase II Design Review Phase II 2/00
. Phase III Design Review Phase III 4/00
. Build 1st 25 Production units Xxxxx XX 0/00
. Xxxxx IV Design Review Phase IV 5/00
. Production Readiness Review Phase V 6/00
8.7. Assumptions
. Xxxx Medical Systems will specify and qualify suppliers for any key
subassemblies and Plexus will be able to purchase from these suppliers
at the Xxxx Medical prices.
. Any inspection data or reports available from previous receipt or
inspection of material will be made available to SeaMED/Plexus in an
effort to reduce material inspection time.
. Xxxx will provide one complete, current set of documentation,
including the specifications called for on any customer documents, and
properly identified (part number and rev) software or magnetic media,
if customer supplied.
. Xxxx will not provide electronic files for an assembly drawing.
---
Therefore, SeaMED will need to generate the files.
. A unit, built to the configuration to be transferred to SeaMED, will
be provided. This unit will be used to generate the Assembly Drawing.
. CAD Models of tooled components such as sheetmetal and cast urethane
plastic parts will be available. Other parts will need to be created by
SeaMED Drafting.
. Xxxx will provide drawings for all parts in the unit.
. SeaMED will release customer-supplied Xxxx drawings into the SeaMED
system without SeaMED signatures.
. Operator's Manuals will be supplied by Xxxx.
. Packaging for the device has been designed by Xxxx/Apical and is
suitable for shipping production units. The packaging documentation
will be released in the Document Transfer process.
Test Specification Documents are supplied by customer.
8.8. Approvals and Customer Deliverables
8.8.1. Customer Approvals Required
The following is a list of items that require Rita's approval. The
Customer will be notified in writing that their approval is
required, but serious delays
can result if the approvals are not granted in a timely way:
. Project Plan
. All Phase -Ending Reviews
. Scope / Specification Change Requests
. Document Change Notices as defined by the Document Change Control
Agreement (DCCA) between SeaMED and Xxxx.
. Production Readiness Review (PRR)
Note: Customer Approval is required per SeaMED Procedure on the
Phase Ending Reviews and the PRR.
8.8.2. SeaMED Approvals Required
The following is a list of items that require approval of the
Director of Project Management:
. Project Plan
. Phase Ending Reviews
The following is a list of items that require approval of SeaMED's
Vice President and General Manager of Manufacturing:
. Production Readiness Review
Note: See SeaMED Design and Phase Ending Review Procedure, 915005
and SeaMED Production Readiness Review Procedure, 913872 for
approvals required.
8.8.3. Signature Authority
. The following are authorized to sign for Xxxx:
. Zia Yassinzadeh (Program Manager), Xxx Xxxxxxx (VP Operations),
Xxx Xxxxxxxx (VP R & D)
8.8.4. Customer Deliverables
. See section 8.6
8.8.5. Summary of Unit Allocation and Pricing
. Unit pricing is defined in the Quote given Xxxx, dated January
12, 2000
. The first P.O. will be for 200 units. All will be built as
Production units.
. Xxxx will conduct correlation testing on the first 25 units to
ensure that units built at SeaMED conform to the Product
Specifications.
8.9. Design Reviews
Various Design Reviews are held throughout a phase as well as at the
completion of each phase, or group of phases as appropriate, and conducted
per SeaMED Design and Phase Ending Review Procedure, 915005. Design
Reviews are documented with a report and
placed into the Project Notebook. Design reviews are identified as a task
on the Project Schedule, (Appendix B).
8.10. Changes to Project - i.e. scope, spec, schedule, responsibility, etc.
The Project Plan is revised and changed through the SeaMED Document Change
Procedure, 900319, at the end of each phase, and additionally when
determined necessary by the Project Director. The Project plan may also be
revised thought the "Scope / Specification Change Request Form," see
Appendix A. This change request form is used when either SeaMED or the
Customer request changes, and is classified into two groups, Major and
Minor. Additional pages may be attached as necessary to describe and
support the request. The Project Director numbers and tracks the Change
number assigned to the Scope Change Request Form. The completed and
approved Scope / Specification Change Request Form becomes part of the
DHF.
Example:
SeaMED recognizes that plans change. SeaMED will notify the customer in
writing of any changes foreseen and the ramifications of changes requested
by either SeaMED or the Customer. SeaMED classifies changes into two
groups.
8.10.1. Minor
. Minor scope changes are those activities which are outside the
work defined in the January 12, 2000 scope that do not affect
milestone dates and are below $2000.
. Minor scope changes may be documented in team meeting minutes,
a Scope Change request form, or an e-mail sent to the
customer, estimating the cost of the change.
. Scope changes may be approved by the customer by written
acknowledgement via letter, fax, or e-mail.
. Scope changes shall be implemented by revising the appropriate
documents, including this project plan.
. Scope change costs will be handled by Xxxx either increasing
the original NRE P.O. or by issuing a P.O. to cover the Scope
Change.
. In the event that it is necessary to DCN a drawing because it
was discovered to be in error or inadequate, and it is
determined that the cause was documentation provided by Xxxx,
the implementation of the DCN will be charged to Xxxx as a
minor scope change. Should the DCN be for the convenience of
SeaMED or to correct a SeaMED error, there will be no charge.
8.10.2. Major
. Major scope changes are those activities which are
outside the work defined in the January 12, 2000 scope
that do affect milestone dates and are in excess of
$2000.
. Major Scope changes require a re-evaluation of the
overall Project schedule and project NRE costs.
. Major scope changes may be documented in a Scope Change
request form, or an e-mail sent to the customer,
estimating the cost of the
change and effect on schedule.
. Major scope changes may be approved by the customer by
written acknowledgement via letter, fax, or e-mail.
. Scope changes shall be implemented by revising the
appropriate documents, including this project plan.
. Scope change costs will be handled by Xxxx either
increasing the original NRE P.O. or by issuing a P.O. to
cover the Scope Change.
8.11. Transfer to Production and Project Closure
. Transfer of the product to production will be per SeaMED
Production Readiness Review Procedure, 913872
9. FINANCE
9.1. Budgets
. This project is a fixed-price project, per the quotation sent
January 12, 2000.
. See Section 6.6 for any revisions to the budget.
. At each Phase-ending Design Review, the project NRE totals and
unit pricing will be reviewed. Any amendments to NRE or unit
pricing will be documented in Phase-Ending Review minutes and a
revision update of this Project Plan,
. See Appendix D for the January 12, 2000 quotation.
9.2. Cost of Units
. The first 25 units will be built to validate the manufacturing
transfer of the device; these units will be billed at actual
material and labor rates. The remainder of the units will be
priced according to the January 12, 2000 quotation.
Appendix A - Scope Change Request Form
Appendix B - Master Schedule (subject to change without revision to this
document)
Appendix C - Material Plan
Appendix D - January 12, 2000 Quotation
Appendix A - Scope / Specification Change Request Form
Sheet 1 of______
Project Name: Change Number:
--------------------------------------------------------------------------------------------------------
Requested by: Date:
--------------------------------------------------------------------------------------------------------
Specification Change: [_] YES [_] NO Scope Change: [_] Major [_] Minor
--------------------------------------------------------------------------------------------------------
Requested Change:
--------------------------------------------------------------------------------------------------------
Reason:
--------------------------------------------------------------------------------------------------------
Schedule Impact:
--------------------------------------------------------------------------------------------------------
Program Cost Impact:
--------------------------------------------------------------------------------------------------------
Unit Cost Impact:
--------------------------------------------------------------------------------------------------------
CUSTOMER RESPONSE: [_] Accept [_] Reject (attach explanation)
----------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------
Reviewed By: (Customer & SeaMED) Date:__________________
Name:___________________________________ Date:_________________
Name:________________________________
--------------------------------------------------------------------------------------------------------
Return completed form to SeaMED, Attn: Project Director
Appendix B - Master Schedule
Team identification and abbreviation table:
On the following schedule, to the right of each task name is the name of the
team member responsible for that task.
Abbreviations used below and in the schedules:
Initials Title/Function Team Member
-------- -------------- -----------
PD Project Director Xxxxxx Xxxxxxx
EE Electrical Engineer None
EET Electrical Technician TBD
Drft Drafter TBD
PCB PCB Designer Xxx Xxxx
MC Materials Coordinator Xxxxxxx Xxxxxx
ME Mechanical Engineer None
MET Mechanical Technician TBD
DC Document Control Technician Xxxxxx Xxxxxxx
QE Quality/Reliability Engineer Xxxxx Xxxxxx
QET Quality Technician TBD
TE Test Engineer Xxxxx Xxxxxxxx,
Xxxxx Xxxxxxxxxx
MfgE Manufacturing Engineer Xxxx HvaI,
Xxxx Xxxxxx
Prod Production TBD
Appendix C - Project Material Plan
REDBUTTE MATERIAL PLAN
1. SCOPE
This document outlines the plans for procurement and management of the
materials required for the Prototype and PreProduction builds of the
RedButte project. This document is supplemental to the existing Project
Plan and associated proposals.
2. PURPOSE
The purpose of this plan is to document the management of the material for
the RedButte project to meet the schedule, cost and manufacturing
objectives.
3. REFERENCE DOCUMENTS
906817 SeaMED Supplier Qualification Procedure
916304 SeaMED Revision Q Procedure
905245 SeaMED Documentation Manual
913571 SeaMED Project Plan Procedure
950053 Project Xxxx, XxxXxxxx
000000 Plan, Manufacturing RedButte
4. MATERIAL TEAM
The Material Support Team (MST) shall consist of representatives
from Purchasing, Stores, Receiving Inspection, Production Control,
and Supplier Quality and shall be under the leadership of a
Material Coordinator. The Material Coordinator shall provide a
single point interface on material matters to the Red Butte
Project Director, to the Red Butte team, and to the customer.
The Material Coordinator reviews the master schedule, interprets
requirements
and develops and manages lower tier schedules which include:
Identification and procurement of long lead material.
Accuracy of the BOM, sales order and/or master schedule.
Release dates of drawings to support schedule.
Supplier approval schedules.
Schedule for initialization of hard tooling.
The Material Coordinator will manage and report to the Project Director
material shortages, excess and inactive inventory amounts, transfer price
estimates, and any material issues which may impact project schedule or
cost.
5. PROTOTYPEBUILD
No prototype units will be built for this project.
6. PREPRODUCTION BUILD
There is no pre-production build. All units are production units built at
rev A. The first 25 units will be billed at actual labor and material cost.
Remaining units will be billed as per unit cost quoted on January 12, 2000
quotation (see appendix D). A long lead (greater than 8 weeks lead time)
BOM will be generated and master scheduled to support the Production
schedule. Upon receipt of a purchase order from Xxxx the master schedule
for the long lead BOM will be removed and a sales order will be loaded to
drive the demand for the remaining material. All custom part drawings will
be released to Revision A for the purchasing team to buy. Assembly drawings
will be released to Revision A prior to work orders being opened.
While the overall responsibility still resides with the Material
Coordinator, the Planner will have the responsibility for the day to day
operations (opening work orders, monitoring shortages, expediting, etc.),
and data entry of the BOM and BOM changes as provided by the Manufacturing
Engineer. The Material Coordinator will work with the Material Team to
implement design changes. The Production Planner will monitor the shortage
report and expedite material from receiving through to the work cell. MRB
meetings will be held as needed to move material through MRB to the work
cell. The Planner will provide shortage reports to the Material
Coordinator.
7. SUPPLIERS
Suppliers for custom parts will be selected the Material Support Team from
suppliers on the Approved Supplier List (ASL). Initially, Rita's suppliers
will be used to meet production deadlines and requirements until SeaMED is
in a position to conduct an orderly transition to its own approved
suppliers.
If a new supplier is needed to meet project production requirements, the
Material Coordinator will initiate and oversee the approval process (ref.
SeaMED Supplier Qualification Procedure 90618). The cost of the approval
process will be billed to the project. A status will be given at Phase
Ending reviews.
Suppliers selected by Xxxx will be added to the ASL with a Conditional
Status-project specific. To initiate this process the customer will send a
letter to the Material Coordinator directing SeaMED to procure from the
specified supplier.
8. CUSTOMER SUPPLIED MATERIAL (CSM)
No customer supplied material will be provided for this project.
9. SPARES AND OTHER NON-PRODUCTION DEMAND
It is the customer's responsibility to identify requirements for spares and
other non-production demand as early as possible. Failure to plan prudently
will result in higher piece part costs and increased risk in achieving
schedules.
10. FINANCIAL
10.1. Excess and Inactive
During the performance of this project, SeaMED will purchase
materials support the requirements defined in the contract agreement
and the project plan. Certain materials that
SeaMED will acquire will be subject to minimum-buy
requirements, scrap and attrition additions and quantity price
breaks which may result in excess material accumulation on the
project. Additionally, design changes may cause other materials to
become inactive. SeaMED will use it's best efforts to minimize the
impact on the project of excess and/or inactive. However, the final
costs associated with the accumulation of excess or inactive
materials (including storage costs if off site storage is required)
will be billed to the customer. A separate SeaMED project billing
account will be opened for RedButte project scrap material for the
development (including PreProduction) phase of the project. Parts
purchased by SeaMED that become inactive due to design changes will
be billed to this account on a monthly basis. Due to the difficulty
in estimating the amount of scrap, it was not included in the NRE
estimate. The Material Coordinator will report on a monthly basis to
the Project Director the status and amount of Excess and Inactive
Material.
10.2. Tooling
The NRE budget does not include estimates for production tooling. If
hard tooling is required, prior to initiation of hard tooling,
estimates will be obtained and additional PO coverage will be
needed.
Ownership of the tooling resides with Xxxx. For confidentiality,
Rita's name will not be marked on the tooling. All tooling purchased
on this contract shall have the following statement added to the
Purchase Order:
The tooling procured or fabricated under this Purchase Order
shall become the property of SeaMED. Each item shall be
permanently marked or labeled "Property of SeaMED Corp." Tooling
shall be returned to SeaMED on request.
10.3. Material Deposits
No material deposit is required.
10.4. Transfer Price Estimate
The Material Coordinator will track the unit price throughout the
development process.
The initial quote was based on a 11/29/99 BOM. It has been agreed
the final transfer price is to be determined following a BOM audit
conducted in January 2000.
Appendix D - Project Quotation
January 12, 2000
Section One
-----------
Company Introduction
The merger of Plexus Corp. and SeaMED Corp. has created a world-class product
development and manufacturing organization with a major focus on creating custom
electronic and electromechanical products for the medical industry. Plexus has
the experience to manufacture and service a complex instrument such as the NSX
device. We have a broad range of capabilities in Procurement, Material Handling,
Quality Assurance, Test, Manufacturing, Quality, Test Engineering, and Customer
Support to support this type of product in the volumes you require.
Corporate Level
Plexus is the premier engineering and product development company in the EMS
industry. Plexus engineering services allow our customers to develop reliable
products delivered to the market on time and at an acceptable unit cost. At
Plexus Corp. we pride ourselves in being able to supply a complete menu of
value-added design and manufacturing services, from which our customers can
choose. The focus of these services is to provide a competitive advantage in
time-to-market, technology, flexibility, and total cost.
The capabilities that Plexus offers span the product life cycle from design,
test, and proto-typing through production manufacturing and depot
repair/service. This range of expertise allows for the seamless transition of a
product from any one phase to another throughout the development and
manufacturing cycle. Plexus is able to support product transition from any of
these phases of the product life cycle. As part of our corporate strategy,
Plexus Corp. provides value-added services while minimizing cost to the
customer.
Section Two
-----------
Procurement and Materials Management
Due to changing market conditions and customer requirements, Plexus is
continuously reviewing materials procurement and management solutions. Our
objective in materials management is to provide the proper mix of flexibility,
low cost and minimal component lead-time to meet our customer's objectives. To
date, we have provided unique solutions for our existing customers, which
include the following:
. Flexibility Model (covers up-side and down-side schedule fluctuations)
. Assured Supply Models
. Xxxx of Material obsolescence review and management
. Proactive Cost Reduction Program
. Transition of supply from existing sources (customer supplied inventory)
. EDI - 830 MRP share with supply base
Each of these strategies is made possible due in part to our excellent supplier
relationships and our supply chain management. Plexus corporate procurement is
broken into Commodity Teams with experience in the industry and established
vendor relationships for each of the major component types (semi-conductors,
mechanical parts, OEM components, passive components, interconnecting devices
and printed circuit boards).
Manufacturing
The facilities are equipped to support a wide range of manufacturing and test
requirements including leading edge technologies as described below. Plexus has
successfully transitioned numerous existing products into manufacturing and has
instituted a dedicated product introduction team to ensure continuity of supply
to our customers. Plexus is committed to on-time delivery and notification in
advance of any delivery variances. Plexus customers have access to a dedicated
Program Manager to provide up to date product manufacturing and delivery status.
In addition we support all of our products in production through Focus Factories
and Product Companies. A typical Focus Factory provides the following services:
. Machinery and staff tailored to your products
. Self managed and directed production staff
. Minimized manufacturing cycle time
. Material acquisition and consumption plans
. Finished goods management
. Agency requirement standards and documentation
. Efficient manufacturing (leading to lower manufacturing costs)
. Higher quality products (information feedback cycle time is shortened)
. Dedicated Mfg. Engineering, Materials, and Quality Engineering resources to
support continuous improvement of the product
Quality Assurance
Plexus has established solutions for quality inspection and test of all printed
circuit card and system level assemblies we manufacture. Quality Engineering
works with the Product Company to resolve supplier related quality issues and
monitor any field failure trends for continuous improvement opportunities.
Test
Our objective in product testing is to provide the proper test type to ensure a
robust product at the lowest possible cost. Our preference is to be involved in
the test development as early as possible in the product design process in order
to maximize test coverage at the board and system level.
The test services Plexus offers include the following:
. In-circuit: HP307X, GenRad 227X & 228X, Teradyne 18XX
. Functional: Base & Nest, Subassembly, stand alone
. Environmental Test: Temperature, vibration, shock
. X-ray Laminography
. Functional Test (custom designed by Plexus or customer supplied)
. Environmental Stress Screen (including vibration, temperature cycling and
shock)
. Automated data collection
. Test software development
. Test fixture fabrication
. Integrated design for testability
Test Engineering
Plexus has a world-class test design staff with experience in developing tests
for medical, industrial, network/telecom, transportation, and other products.
For new test requirements, we utilize state-of-the-art development tools,
processes and procedures that enable us to develop comprehensive manufacturing
test strategies and solutions while managing the NRE costs associated with the
program.
Customer Support
Plexus provides a Customer Support Representative for every customer. The
Customer Support Representative will provide you information on order and
material status, billing and cost information, service and warranty information,
and also provides a point of contact for any additional technical services you
might need from minor design changes to complete redesigns, and new product
introductions.
Section Three
-------------
Unit Price
The unit price is budgetary and is based on the model 1500 BOM dated 11/29/99.
Any changes to this BOM may affect the final unit cost. Please see Attachment A
for pricing details.
Unit Labor Price
Board level labor is an estimate. Firm custom PCBA labor pricing will be based
upon an accurate BOM, assembly drawings, fab drawings, and or a sample. The HLA
unit labor price for the device is based on a cellular manufacturing approach
for the device. This cell will incorporate point-of-use stocked material and a
progressive assembly and test approach. The Product will be built by assemblers
and tested by Production Technicians; at lower volumes the product may be built
and tested by Production Technicians.
Unit Materials Price
Unit material price is budgetary and is based on the BOM that was dated
11/29/99. When comparing the BOM with the individual BOMS provided 12/15/99 we
found many parts discrepancies. We ignored the individual BOMS and got quotes on
the BOM dated 11/29/99. In order to solidify material pricing we will need
accurate assembly BOMS completed with manufactures and manufactures P/N's.
Please see attachment B for comments for custom components. Please see
attachment C for material pricing comments.
Unit Test Price
Based on our experience with similar products the following tests have been
added to the unit labor cost.
. Back-plane
. CPU PCA
. IO PCA
. Thermo Board
. Display Driver Board
. Display Board
. RF Board
. System Test
. Electrical Safety
. Run-in Test
. Final Test
. QA Final Test
Unit Pricing Notes and Assumptions
. The assembly labor hours were derived by assembling unit Serial Number 002
that was provided by Xxxx. There have not been any major mechanical design
changes since that time that would significantly affect the assembly process.
. Minimal amount of Loctite is used. Recommend changing to SEM screws and
Kepnuts where possible.
. Calibration of unit is expected to be direct and not iterative. All
calibrations are independent. Test procedures were not available to actually
perform this operation at the time of this estimate.
. Programmable devices can be programmed on an Allpro model 96 programmer and
there are six programmable devices in the unit (five SMT and one DIP).
. Power Entry Module assembly can be performed and is sufficiently documented
for assembly by sub-contract wire harness supplier.
. The RF PCBA only requires attachment of the Fan and Bracket to the Heatsink
in Final Assembly. All other assembly (including daughter PCBA/Hybrid) will
be performed by PCBA assembly manufacturer.
. No Polyimide Tape in unit.
. No soldering of wires such as the Fan to the RF PCBA. All connections are
made with connectors.
. This quotation is valid for thirty (30) days. Prices will be firm for orders
placed within this thirty (30) day period and deliverable within one year of
the date of this quotation.
. Plexus Professional Service Agreement (PSA) or similar, comprehensive
manufacturing agreement to be complete and in place prior to acceptance of
purchase order for production units.
. Customer has a completed product specification.
. All critical sub-assemblies have been qualified to meet product specification
requirements.
. There will be 25 units built to validate the manufacturing transfer of the
device; these units will be billed at actual material and labor rates.
. The BOM used for estimating the Unit Cost is based on information provided by
Xxxx Medical and our understanding of the system.
. Xxxx Medical Systems will specify and qualify vendors for any key
subassemblies and Plexus will be able to purchase from these suppliers at the
Xxxx Medical prices.
. Changes to the system design and/or manufacturing process, after release for
production, will include review and written approval by both Xxxx Medical
Systems and Plexus.
. Assembly, Test, and Receiving Inspection first pass yields will be at least
95%.
. Any materials transferred to SeaMED/Plexus will be shipped in individual
containers with SeaMED/Plexus part numbers for easy identification.
. Any inspection data or reports available from previous receipt or inspection
of material should be made available to SeaMED/Plexus in an effort to reduce
material inspection time.
. Plexus Electronic Assembly normally uses No Clean Solder Paste and Wave
Soldering Flux. Plexus Electronic Assembly does not attempt to clean the flux
residues from assemblies unless otherwise specified.
. Plexus Electronic Assembly Documentation Control Dept. will require the
following at the time a purchase order is placed:
A. One complete, current set of documentation.
B. The specifications called for on any customer documents.
C. Properly identified (part number and rev) software or magnetic media, if
customer supplied.
. Plexus Electronic Assembly must be placed on internal routings, to ensure
that we will always have the latest revision of any of the above.
. Plexus' Corporate Engineering, Safety and Environmental Departments must
review all chemicals specified for the manufacture of the products herein for
health and safety issues, compliance with regulations and manufacturability.
. All products, test fixtures and manufacturing equipment required to assemble
these products must be year 2000 compliant before acceptance of purchase
order.
. Terms of payment are net-thirty (30) days and subject to final credit
approval by Plexus Electronic Assembly.
. All shipments are FOB point of shipment Bothell, WA
Section Four
------------
Mfg. Transfer Non-Recurring Encilneerina Services for the Model 1500
--------------------------------------------------------------------
1. Assembly Drawing and Instructions Generation $13,450
Value Added Service:
. Create Assembly Drawing with Instructions that SeaMED can use to build the
device.
Assumptions:
. Xxxx will not provide electronic files for an assembly drawing. Therefore,
---
SeaMED will need to generate the files.
. A unit, built to the configuration to be transferred to SeaMED, will be
provided. This unit will be used to generate the Assembly Drawing.
. CAD Models of tooled components such as sheetmetal and cast urethane
plastic parts will be available. Other parts will need to be created by
Drafting.
2. Documentation Transfer $16,700
Value Added Service:
. Drawings will be released in SeaMED's system in order to procure, inspect,
and stock parts for manufacturing.
. SeaMED will minimize the cost of this activity by simply taking Rita's
drawings, creating a part number, and releasing them as is with a cover
sheet.
Assumptions:
. Xxxx will provide drawings for all parts in the unit.
. Documents will be transferred at $50/part.
. Per a Xxxx Excel BOM, dated 11-29-99, there are 392 parts that need to be
transferred.
. There will only be one A-Level assembly.
. All drawings have had a thorough tolerance analysis and include complete
material and finish callouts.
. All dimensions are in inches.
. All components have completed Source Control Drawings that include
manufacturer, part numbers and data sheets.
3. Production Process Setup $16,800
Value Added Service:
. Create a Manufacturing Plan that will ensure the product is built in the
most efficient manner.
. The production processes to build and test the device will be created at
SeaMED.
. Generate the Xxxx of Material in MRP to structure material procurement and
the manufacturing process in the most efficient manner.
. All assembly tools will be identified and setup in the Product Cell at the
point of use.
. Any assembly fixtures needed will be identified during this activity.
. Assemblers and Technicians will be trained to build and test the device.
. Release of the Product and Processes to production.
Assumptions:
. Hands on training at Apical where units could be built, tested, and
shipped by SeaMED personnel will not be provided.
---
. A unit, built to the configuration to be transferred, will be provided to
SeaMED in order to setup the manufacturing process.
. A representative of Xxxx who knows the product, will be on-site at SeaMED
as needed to help set up the manufacturing process.
. There is minimal tribal knowledge required to build and test the unit.
. Generic assembly tools (e.g. screwdrivers, torque drivers, wrenches, etc.)
are not charged to the customer.
. No assembly fixtures and jigs will be transferred to SeaMED. The cost to
build assembly fixtures is not included in this cost estimate.
. A Process FMEA is already done by Xxxx and is not part of this proposal.
The Process FMEA will be released in the Document Transfer process.
. Operators' Manuals will be supplied by Xxxx.
. Packaging for the device has been designed by Xxxx/Apical and is suitable
for shipping production units. The packaging documentation will be
released in the Document Transfer process.
4. Mfg. Test Planning and Approach $14,700
Value Added Service:
. A manufacturing test plan will be developed to outline the approach for
testing the device in production. The customer will approve this plan
before proceeding into detailed test fixture design and development.
. A manufacturing test specification will be developed that outlines all of
the characteristics that will be tested on the device and to what
tolerance.
Assumptions:
. Due to low quantities, ICT will not be implemented, however the PCBAs
could be modified to allow for ICT in the future should quantities exceed
estimates.
. ICT fixtures and programming are not included in this proposal and exceed
the scope the
project. All tests are manual with the exception of Run-In Test which will
be automated.
. Testing will consist of PCBA and system level tests. Power supply voltages
and signals necessary to meet device specifications will be measured.
. The HCU's software will be used in a test mode to read external stimulus
(inputs) and control outputs that will be measured by independent test
equipment.
. The safety functions will also be tested.
. PCBAs may be tested in the system or on a bench top tester depending on
access to the PCBAs in the HCU.
. Electrical safety of the HCU will be tested. This will consist of leakage
current tests and dielectric strength tests. These tests will not require
or include the disposable.
5. Mfg. Test Procedures $33,495
Value Added Service:
The following test procedures will be developed and released to test the model
1500 in manufacturing:
. Back-plane
. CPU PCA
. IO PCA
. Thermo Board
. Display Driver Board
. Display Board
. RF Board
. System Test
. Electrical Safety
. Run-in Test
. Final Test
. QA Final Test
Assumptions:
none
6. Mfg. Test Fixture Material and Labor $44,750
Value Added Service:
. Golden Board Test Fixture (GBTF) will be designed and built to support board
level test, calibration and debugging of individual PCBAs. This fixture will
also be used to provide in/out of house service boards. This fixture will
include various RF loads, thermocouple simulation, provide open thermocouple
simulation, load for audio drivers, and foot switch or foot switch simulator.
Additional bench top equipment will be required to
support the testing including a temperature measuring device, PC (to
communicate with the unit), Oscilloscope, DMM, etc. Standard bench top test
equipment is supplied by SeaMED. Specialized equipment specific to the HCU
testing or equipment built into test fixtures is charged to the customer.
. System Test Fixture will be almost identical to the GBTF less the portion
that holds and powers the Golden Boards. It will probably share the various
RF loads, Thermocouple simulation, provide open thermocouple simulation, load
for audio drivers, and foot switch or foot switch simulator. The bench top
test equipment will also be shared. This approach will reduce the quantity of
fixtures and equipment and therefore cost.
. Run-In Test Fixture will be very dependent on the type of requirements
defined by the customer. The level of support needed to energize the RF
output and the duration it can be driven will affect the complexity of the
fixture design. We propose the fixture be modular and initially be built to
support 4 units simultaneously. It will be designed to extend to 8 units by
adding components when higher production quantities require additional
capacity. The approach includes a PC, 8 port RS-232 board, Digital I/O board,
AC line control switch system, RF loads and pneumatic control system. Test
software will be developed to automate this fixture.
. The Electrical Safety Test will use SeaMED's safety analyzer and Hipot
tester. Custom cables will be required to connect the unit being tested to
the test equipment. These are considered test fixtures and will be
documented, verified, and validated as such.
. The Quality Assurance (QA) Final will be a stripped down version of the
System Test Fixture. It will not require bench top test equipment.
Assumptions:
. The system test pneumatic system could be eliminated if the unit's RF output
can be Controlled via its RS-232 port or method other than the foot switch.
If the unit's RF output can be controlled continuously without over heating
the unit and there is no requirement for power cycling, the majority of the
test equipment can be eliminated. This proposal estimates the worst case cost
for a 4 station run-in test fixture.
. The GBTF gold board set is not included in the cost of this proposal.
7. Additional Documentation Included
The following documentation will be created during the test development process.
. Manufacturing Test Plan.
. Test Specification Documents (supplied by customer).
. Test Fixture Documentation including Theory of operation, Verification and
Validation
Procedures (one for each type of fixture).
. Test Fixture Verification and Validation Reports (one for each type of
fixture).
. Test Procedures (one for each test identified above).
. Test Procedure Verification Reports.
8. PCBA Design Upgrade $6,000
This section covers the added design work and costs to move the PCB mounted
switches to a new membrane switch panel. The plan would incorporate this design
concurrent with manufacturing transfer of the device, starting with concurrent
approval. SeaMED will provide the PCBA redesign, Xxxx will perform the redesign
of the Front Panel and overlay.
Value added service:
. Re-layout the LED PCBA to:
. Remove switches and obsolete traces
. Eliminate interference between PCB and connectors
. Trim/notch PCB top and bottom
. Add 11 position single row ribbon cable locking connector
. Eliminate extra mounting holes not needed
Assumptions:
. Existing electronic files are available for the PCB in a format that can be
used at SeaMED.
. No function or specification change to unit or unit performance.
. No re-qualification required.
Estimate - Labor NRE --- EE, PCB designer, ME, drafting -- $6,000
Material NRE
None.
At this time it is not envisioned that a prototype run the new PCBA
will be done. Film and tooling for the PCB will be billed out as a
pass-through cost when parts are ordered for production
TOTAL DESIGN NRE -- $6,000
9. Additional Engineering Services Requested By Xxxx Medical
Value Added Service:
. Review BOM dated 11/29/99 with 392 parts listed and audit to physical sample
provided by Xxxx Medical week of 1/3/00 to correct any BOM errors prior to
loading BOM into SeaMED MRP system. Manufacturers and P/Ns will also be
audited as part of this process. Any discrepancies will be reported to Xxxx
Medical for disposition. $6,600
. Document 9 Wire Harnesses from BOM and Physical sample provided by Xxxx
Medical. These documents will be suitable for purchasing wire harnesses as
sub-assemblies from wire harness suppliers. $4,140
. Create source control drawings for parts that are not currently documented at
SeaMED. There are approximately 262 parts that will require SCDs and we
estimate that we will have to create SCDs for approximately 1/3 of these or 87
SCDs. $6,633.
[BAR TABLE GRAPHICS]
[BAR TABLE GRAPHICS]
Attachment C
[LOGO HERE] Plexus Corporation Quote # 0
The Product Realization Company 0000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000-0000 Date: 2/28/00
(000) 000-0000 Fax (000) 000-0000
===================================================================================================================================
Company: Xxxx Medical Systems Project Name: Ablation System
000 X. Xxxxxxxxx Xxxx. Assembly #: Model 0000
Xxxxxxxx Xxxx, XX Assembly Rev: N/A
Assembly Name:
Attention: Xxx Xxxxxxx Prepared by: Xxxx Xxxxx
cc: Phone: 000-000-0000
UNIT COST INFORMATION
---------------------------------------
Estimated Annual Quantity [***] [***] [***] [***]
---------------------------------------
Estimated Release Quantity [***] [***] [***] [***]
---------------------------------------
I. MATERIALS [***] [***] [***] [***]
II. PCBA LABOR [***] [***] [***] [***]
III. FINAL ASSY. LABOR [***] [***] [***] [***]
IV. ICT TEST N/A N/A N/A N/A
V. FUNCTIONAL TEST Inc. Inc. Inc. Inc.
VI. RUN IN TEST Inc. Inc. Inc. Inc.
VII. PACKAGING Inc. Inc. Inc. Inc.
----------------------------------------
VIII. TOTAL [***] [***] [***] [***]
----------------------------------------
INVENTORY CARRY/MONTH [***] [***] [***] [***]
See Note 3
Notes
-----
1. ICT Test is not included, PCBA design does not support ICT.
2. Functional PCBA, System Test, Ambient Run-In Test. Electrial Saftey, and
Final Testing Inc. in Final Assy Labor.
3. Investory Carrying Cost/Month is based on purchasing [***] in material for
Initial PO of [***] units.
On initial PO of less than [***] units a carrying charge of [***] will
apply from date of last shipment on Initial PO to date of first shipment
on next PO.
NON-RECURRING CHARGES
A. PCB TOOLING [***]
B. PCB ETF [***]
C. ICT FIXTURE N/A
D. FUNCTIONAL FIXTURE [***]
E. PCBA PROCESS DEVELOPMENT N/C
F. XRAY TOOLING N/A
G. SMT PROGRAMMING Inc.
H. SMT STENCIL (S) Inc.
I. AUTO-INSERT PROGRAMMING N/A
J. CONFORMAL COATING PROG. N/A
K. MANUFACTURING SETUP [***]
L. OTHER [***]
SPECIFIC ASSEMBLY NOTES AND ASSUMPTIONS
A. See Previous Proposal Dated January 12, 2000.
B. Final Assembly Labor is Estimated Within +/- 15%.
C. Current PCB Supplier is Capable of Meeting Plexus Production
Requirements.
D. PCBA process development costs up to [***] will be paid by Plexus.
E. Xxxx Medical responsible for additional costs due to design costs.
F.
G.
H.
Attachment D
1. DESCRIPTION
The XXXX Medical Systems, Inc. Model 1500 Series Electrosurgical Generator
is designed to provide monopolar radio frequency energy to be used for
coagulation and ablation of soft tissue. The unit is specifically designed
for use with XXXX Electrosurgical Devices. It provides multiple
temperature sensor measurements, impedance and power monitoring to assist
the practitioner in delivering the desired energy to the target tissue.
The XXXX Electrosurgical system consists of an RF generator, a disposable
electrode, here referred to as the device, a patient connection cable, a
return pad, a power cord, and may also include an auxiliary temperature
probe. The generator provides the RF energy to the device through the
cable. The device consists of a number of deployable branches, some or all
equipped with a thermocouple. The return pad, also known as the dispersive
electrode, provides the return path for the RF energy applied by the
device. The power cord is a medical grade line cord that provides AC power
to the generator. The system is capable of reading up to three auxiliary
temperatures through a passive auxiliary probe. This probe is not capable
of delivering any RF energy, and is used to provide temperature information
about the surrounding tissue. This probe is connected to the auxiliary
port of the generator via an auxiliary cable.
To use the system, the generator is plugged into the wall outlet. The
device is connected to the generator via the patient connection cable. The
dispersive electrode is placed on the appropriate location on the body and
connected to its port on the generator. Once the system is successfully
powered up, the user can set the parameters of the procedure such as the
mode of operation, procedure time, procedure temperature, and the power
delivery level. With the device placed in the tissue to be ablated and its
electrodes deployed, RF can be turned on. The system parameters are
continuously monitored and reported by the generator. If the measured
parameters are outside the acceptable limits, the RF energy delivery stops
and a message appears on the LCD display. The RF energy delivery ceases
once the procedure is completed based on the initial user defined
parameters.
2. SPECIFICATION
2.1. Product Classification
Base on IEC 601-1 the product is classified as Class I, Defibrillator
Proof, type BF Medical Electrical Equipment.
2.2. Power Requirements
100-240V, 50-60 Hz. Auto switching universal power supply.
2.3. Rated Input Power
600 VA
2.4. Rated Output Power
2.4.1. 150 Xxxxx into25-100 OHMS
2.4.2. Minimum of 100 Xxxxx into impedance ranges of 10-25 OHMS, and
100-150 OHMS
2.4.3. Power Accuracy +/-10% or 2 Xxxxx, whichever is greater
2.4.4. Operating Frequency 460 kHz +/-5%
2.5. Environmental
2.5.1. Temperature 10-40(degrees)C
2.5.2. Humidity 85% Non-Condensing
2.6. Operating Impedance
2.6.1. 00-000 XXXX in all modes
2.6.2. Outside these ranges RF can not get activated, or if active
it will turn OFF.
2.6.3. Impedance Accuracy +/-20%
2.7. Temperature Measurement
2.7.1. Up to 9 channels of temperature measurement. Six channels of
device temperature monitoring and three channels of passive
electrode temperature monitoring
2.7.2. T type thermocouple temperature sensors
2.7.3. Cold Junction Compensation capability
2.7.4. Temperature measurement display range 15(degrees)C to
125(degrees)C. Internal measurement capability up to
150(degrees)C minimum.
2.7.5. Temperature measurement accuracy +/-3(degrees)C for 20-
120(degrees)C, -5/+3(degrees)C for LO,-3/+5(degrees)C for HI,
+5(degrees)C for OP.
2.8. Microprocessor
Motorola 68HC11
2.9. Software
Mainly in "C" Language Software Programming. Assembly language to be
used as required.
2.10. User Interface
2.10.1. Front Panel Ports
2.10.1.1. Device Port: Provide means of connecting the
device to the generator via the patient cable.
The port is keyed for proper connection.
2.10.1.2. Auxiliary Port: Provides means of connecting the
passive probe to the generator via the auxiliary
cable. The port is keyed (different from the
Device port) for proper connection.
2.10.1.3. Return Pad Port: Provides means for connecting a
dual pad Dispersive Electrode to the generator.
2.10.1.4. Foot Pedal Port: Connects a pneumatic foot
switch for activating and deactivating RF
delivery.
2.10.2. Front Panel Switches
2.10.2.1. RF ON/OFF Switch: Push type switch to turn the
RF energy delivery ON and OFF.
2.10.2.2. Track Ablation Switch: Toggles the system in and
out of Track Ablation mode. In this mode the
power defaults to 15 xxxxx and can be adjusted
from 0 to 25 xxxxx.
2.10.2.3. Control Mode Switch: Sets the mode of operation.
Modes are:
. Automatic Temperature Control (ATC). Uses
temperature as feedback for delivery of power.
There are three Modes under ATC:
A. ATC on average of all selected
thermocouples. This is an automatic
control mode of operation where the
power delivery is served about a set
temperature point. The measured
temperature used in this control loop is
the average of all selected temperature
sensors of the device.
B. ATC on the highest reading. This is the
same as in A above, except that the
measured temperature for the control
loop is the highest reading of all the
selected thermocouple.
C. ATC on the lowest reading. This is the
same as in A above. except that the
measured temperature for the
control loop is the lowest reading of
all the selected thermocouple.
. Power Control. This is an automatic control mode
of operation where the power delivery is servoed
about a set power. The system delivers the
maximum of the preset power for the preset
amount of time. In this mode measured
temperatures are displayed only, and are not
used in the control of the power delivery.
2.10.2.4. Set Temperature Switches: An up switch and a
down switch for setting the target temperature
set point in ATC mode. This is the maximum
temperature the system would try to achieve and
maintain during the procedure. Target
temperature can be set from 50-120(degrees)C
with 1(degrees)C resolution. Default is
100(degrees)C. Target temperature can be changed
at any time during the procedure.
2.10.2.5. Set Power Switches: An up switch and a down
switch to set the maximum power the system would
deliver during the procedure. In Power Control
default is set to 1 Watt, in ATC mode default is
set to 150 Xxxxx. Power set resolution is 1
Watt. Switches when held down will auto
increment/decrement the Power set.
2.10.2.6. Timer Switches: Sets the time the treatment
would run at the set point temperature in ATC.
In Power mode this sets the RF delivery time.
Time can be set from 0.1 to 60.0 minutes in 0.1
minute resolution. Once this time is counted
down to zero, RF delivery ceases. An up switch
and a down switch set the Timer value. These
switches can be held down to auto increment
decrement. A third switch (Manual Timer Switch),
in the ATC mode allows the user to manually
start the count down once the RF delivery
starts. In ATC mode the count down starts when
the measured temperature is equal or greater
than the target temperature for 15 seconds.
Count down stops if the measured temperature is
5(degrees)C less than the target temperature for
15 seconds. Default timer is set to 8.0 minutes.
2.10.2.7. Device Temperature Switches: Each Device
Temperature sensor has an accompanying switch
adjacent to its display. The switch is used to
select or deselect the reading of the sensor in
the temperature control algorithm. If the sensor
is selected, its reading is used in the
calculation of the average device temperature,
or in determining the highest or lowest measured
temperatures. The last sensor can not be
deselected in the ATC mode prior or during RF
delivery.
2.10.2.8. Auxiliary Temperature Switches: Each Auxiliary
Temperature sensor has an accompanying switch
adjacent to its display. These switches function
similar to Device Temperature sensors.
2.10.3. Front Panel LED's
2.10.3.1. RF LED: A blue LED that flashes once a second
when the system is in standby. When RF is turned
on, this LED stays on continuously. The LED is
OFF under system failure condition.
2.10.3.2. Track Ablation LED: A green LED that is OFF when
this mode is not selected, flashing
approximately every second when the mode is
selected, and is ON when the mode is active.
2.10.3.3. Device Temperature LED's: Each Device
Temperature sensor has an accompanying green LED
adjacent to its display. The LED is ON when the
temperature sensor is selected and is OFF when
it is deselected.
2.10.3.4. Auxiliary Temperature LED's: Each Auxiliary
Temperature sensor has an accompanying green LED
adjacent to its display. The LED's function
similar to Device LED's.
2.10.4. Front Panel Displays:
2.10.4.1. LCD Display: A 40 x 2 character back lit LCD.
Informs the user of the status of the generator.
2.10.4.2. Control Mode Display: A two digit, seven
segment, green LED display for displaying the
mode of operation. It displays:
A For ATC average on all selected thermocouples
H For ATC on the highest thermocouple reading
L For ATC on the lowest thermocouple reading
P For Automatic Power Control
C For Track Ablation
2.10.4.3. Set Temp Display: A three digit, seven segment,
green LED display for displaying the Set
Temperature in whole units of (degrees)C.
2.10.4.4. Set Temp Display: A three digit, seven segment,
green LED display for displaying the Set Power
in whole units of xxxxx.
2.10.4.5. Power Delivered Display: A three digit, seven
segment, green LED display for displaying
instantaneous power delivered in whole units of
xxxxx.
2.10.4.6. Timer Display: A three digit, seven segment,
green LED display. Displays time to 1/10 of a
minute resolution. Maximum allowed time is 60.0
minutes. This display, prior to the start of the
treatment, shows the time set for treatment at
the set point temperature. Once the treatment
starts, the display shows the remaining time of
treatment at the preset temperature. If the set
point is lost, the timer also stops. The count
down resumes once the target temperature is
reached again. During Cool Down cycle, this
display counts up 0.5 minute to indicate the
duration of this cycle.
2.10.4.7. RF Time Display: A three digit, seven segment,
green LED display. Displays total time RF has
been on in 1/10 of a minute resolution. The
display resets to zero at the onset of a new
treatment cycle.
2.10.4.8. Impedance Display: A three digit, seven segment,
green LED display. Displays the real time
impedance value of the tissue in whole units of
ohms. The display shows impedance range of 0-
999(OHMS). If the measured impedance is above
999(OHMS), the display shows OP.
2.10.4.9. Device Temperature Displays: 6, three digit,
seven segment, green LED displays that display
the temperature readings of the device
thermocouples in whole units of (degrees)C for
temperatures between 15-125(degrees)C. For
temperatures below 15(degrees)C, LO is
displayed. For temperatures greater than
125(degrees)C and less than 150(degrees)C HI is
displayed. For temperatures above 150(degrees)C
OP is displayed. OP is also displayed if there
are no thermocouples present in that location.
If all temperature channels measure OP, the
displays remain blank. When HI is displayed or
when OP is displayed for values above
150(degrees)C, the actual temperature readings
are used for the temperature control algorithm.
2.10.4.10. Auxiliary Temperature Displays: 3, three digit,
seven segment, green LED displays that display
the temperature readings of the thermocouples in
the passive auxiliary probe. The auxiliary probe
displays functions similar to the Device
Temperature Displays.
2.10.5. Power Entry Module
Located on the rear of the generator. The module is
equipped with fuses on line and neutral. It also includes
the main power switch. The fuses are rated at 6.3 Amps.
2.10.6. Equipotential Stud
Located on the rear panel of the generator.
2.10.7. XX-000 Xxxx
XX-0 connector located on the rear panel of the generator.
Unidirectional, 9600 Baud,8 bits, I stop bit, and no
parity. Rx pin 2, Tx pin 3, GND pin 5. Cable is a direct
1:1 connection, no (Rx, Tx) reversal.
2.10.8. Buzzer
To provide audible feedback when the state of the machine
is changed, or the switches are pressed, and when RF
delivery is active.
2.11. Mechanical
2.11.1. Dimensions: 14.75 IN wide, 17 IN deep, 5.25 IN high
2.11.2. Weight: 25 lbs, +10%.
-
2.11.3. Enclosure: Steel enclosure with plastic front bezel and
side brackets with RITA's approved colors.
2.11.4. Overlay: Front overlay with RITA's approved graphics and
colors.
2.12. Shipping and Vibration
ASTM-D41 69
2.13. Cleaning and Disinfecting
Isopropyl alcohol can be used with no degradation in quality and
finish of labels.
2.14. Standards
U12601, IEC 000-0, XXX 000-0-0, XXX 601-2-2. Must meet the
requirements of FDA Quality System Regulation, 21CFR820, Medical
Device Directive 93/42/EEC, and Quality System Standards, ISO 9001,
and EN 46001.
3. ACCESSORIES SPECIFICATIONS
3.1. Device Specification
Refer to each product's Design Inputs documents.
3.2. Auxiliary Temperature Probe
Refer to each product's Design Inputs documents.
3.3. Auxiliary Temperature Cable Specification
3.3.1. The auxiliary cable shall have locking, keyed connectors for
connection to only the Model 500 and 1500 Series RF Generator
on one end and only XXXX Auxiliary Temperature Probes on
other end. The connectors shall be the same on both ends.
3.3.2. The auxiliary cable shall meet the IEC 601-1 requirements for
cables and interconnects.
3.3.3. The auxiliary cable shall be 120+2 inches long.
-
3.3.4. The auxiliary cable shall be manufactured non-sterile but be
reusable (be capable of withstanding 50 steam sterilization
cycles.
3.4. Main Cable Specification
3.4.1. The main cable shall have locking, keyed connectors for
connection to only the Model 1500 Series RF Generator on one
end and only XXXX Devices on other end. The connectors shall
be the same on both ends.
3.4.2. The main cable shall meet the IEC 601-1 requirements for
cables and interconnects.
3.4.3. The main cable shall be 120+2 inches long.
-
3.4.4. The main cable shall be manufactured non-sterile but be
reusable (be capable of withstanding 50 steam sterilization
cycles.
3.5. Dispersive Electrode Specification
3.5.1. The dispersive electrode shall meet the appropriate sections
of AAMI/ANSI HF18.
3.5.2. The dispersive electrode shall be capable of adhering
adequately to skin without adverse skin irritation upon
removal.
3.5.3. The dispersive electrode area shall be of sufficient size to
dissipate energy at the maximum rated power output in
accordance with ANSI/AAMI HF-18 requirements.
3.5.4. The connector on the dispersive electrode shall be compatible
with the dispersive electrode connection port on the Model
1500 Series RF Generator.
3.6. Power Cord Specification
3.6.1. The power cord shall be a medical grade line cord that
provides AC power to the generator
3.7. Foot Pedal Specification
3.7.1. The foot pedal shall be a pneumatic-type switch that allows
continuous RF energy.
3.7.2. The connector on the foot pedal shall be compatible with the
foot pedal connection port on the Model 1500 RF Generator.
3.7.3. The user shall be able to use the foot pedal to turn on RF
power only when the RF Generator is in Ready mode.
3.7.4. The user shall be able to use the foot pedal to turn off RF
power at any time.
3.7.5 The length of the cable connecting the foot pedal to the RF
generator shall be 120+4 inches
-
ATTACHMENT D
1. SCOPE
The purpose of this document is to describe the software used in the model
1500 RF generator and to provide a guide for its verification.
This document only applies to the software used in the XXXX model 1500
Generator.
2. PRODUCT DEFINITION
The XXXX Medical Systems, Inc. Model 1500 Series Electrosurgical Generator
is designed to provide monopolar radiofrequency energy to be used for
coagulation and ablation of soft tissue. The unit is specifically designed
for use with XXXX Electrosurgical Devices. It provides multiple
temperature sensor measurements,
impedance and power monitoring to assist the practitioner in delivering the
desired energy to the target tissue.
The XXXX Electrosurgical system consists of an RF generator, a disposable
electrode, here referred to as the device, a patient connection cable, a
return pad, a power cord, and may also include an auxiliary temperature
probe. The generator provides the RF energy to the device through the
cable. The device consists of a number of deployable branches, some or all
equipped with a thermocouple. The return pad also known as the dispersive
electrode, provides the return path for the RF energy applied by the
device. The power cord is a medical grade line cord that provides AC power
to the generator. The system is capable of reading up to three auxiliary
temperatures through a passive auxiliary probe. This probe is not capable
of delivering any RF energy, and is used to provide temperature information
about the surrounding tissue. This probe is connected to the auxiliary
port of the generator via an auxiliary cable.
To use the system, the generator is plugged into the wall outlet. The
device is connected to the generator via the patient connection cable. The
dispersive electrode is placed on the appropriate location on the body and
connected to its port on the generator. Once the system is successfully
powered up, the user can set the parameters of the procedure such as the
mode of operation, procedure time, procedure temperature, and the power
delivery level. With the device placed in the tissue to be ablated and its
electrodes deployed, RF can be turned on. The system parameters are
continuously monitored and reported by the generator. If the measured
parameters are outside the acceptable limits the RF energy delivery stops
and a message appears on the LCD display. The RF energy delivery ceases
once the procedure is completed based on the initial user defined
parameters.
3. OVERALL SYSTEM DESCRIPTION
The XXXX Generator is a class I, Defibrillator proof, type BF medical
equipment. The system is powered by a universal power supply, and can
deliver 150 xxxxx of RF energy. The range of allowable impedance is 10-
999U. The system runs on a Motorola 68HC11 microprocessor with "C"
programming language software. The user interface and functions are as
follow:
3.1. RS-232 Unidirectional serial port located on
the rear panel
3.2. RF ON/OFF Switch Turns the RF energy on and off
3.3. Foot Pedal Functions like RF ON/OFF switch
3.4. RF LED A blue LED that flashes once a second
when system is in standby, and is
continuously on when the RF is being
delivered.
3.5. Track Ablation Switch Toggles the system in and out of Track
Ablation (TA) mode. It also turns RF OFF
when RF is active in TA mode. It can not
turn RF ON. TA mode allows the user to
ablate the needle track usually at the
termination of a procedure. In this mode
the power defaults to 15 xxxxx and can
be adjusted from 0 to 25 xxxxx.
Temperatures are monitored in this mode.
No time information is available. The
buzzer beeps intermittently in this
mode.
3.6. Track Ablation LED A green LED that is off when this mode
is not selected, flashing when the mode
is selected, and is on when the mode is
active.
3.7. Control Mode Switch Sets the mode of operation. The modes
are:
1. Automatic Temperature Control
(ATC). Uses temperature as feedback
for delivery of power. There are
three modes under ATC:
A. ATC on average of all selected
thermocouples. This is an
automatic control mode of
operation where the power.
B. delivery is servo controlled
about a set temperature point.
The measured temperature used
in this control loop is the
average of all selected
temperature sensors of the
device.
C. ATC on the highest reading.
This is the same as in A
above; except that the
measured temperature for the
control loop is the highest
reading of all the selected
thermocouple.
D. ATC on the lowest reading.
This is the same as in A
above, except that the
measured temperature for the
control loop is the lowest
reading of all the selected
thermocouple.
2. Power Control. This is an automatic
control mode of operation where the
power delivery is servoed about a
set power. The system delivers the
pre set power for the pre set
amount of time. In this mode
measured temperatures are displayed
only, and are not used in the
control of the power delivery.
3.8. Control Mode Display Displays:
"A" For ATC on all selected
thermocouples
"H" For ATC on the highest thermocouple
reading
"L" For ATC on the lowest thermocouple
reading
"P" For Automatic Power Control
"C" For Track Ablation
3.9. Set Temp Display Displays the set temperature in whole
units of (degrees)C.
3.10. Set Temp Switches The up arrow increments and the down
arrow decrements the temperature set
point. The set point is the maximum
temperature the system would try to
achieve and maintain during the
procedure. Temperature can be set from
50-120(degrees)C. The switches can be
held down for auto increment/decrement.
3.11. Set Power Switches Sets the maximum power the system would
deliver during the procedure. The up
arrow increments and the down arrow
decrements the setting respectively.
Power can be set from 1-150 xxxxx. The
switches can be held down for auto
increment/decrement.
3.12. Set Power Display Displays the power setting in whole
units of xxxxx.
3.13. Power Delivered Display Displays the instantaneous power
delivered in whole units of xxxxx.
3.14 Timer Switches Sets the time that the treatment would
run at the set point temperature. Once
this time is count down to zero the RF
delivery ceases. The up
arrow switch increments and the down
arrow switch decrements the desired time
setting. These two switches can be held
down for auto increment/decrement. The
third switch allows the user to manually
start the count down once the RF
delivery starts.
3.15. Timer Display Displays the time to 1/10 of a minute
resolution. Maximum allowed time is 60.0
minutes. This display, prior to the
start of the treatment, shows the time
set for treatment at the set point
temperature. Once the treatment starts
the display shows the remaining time of
treatment at the preset temperature. If
the set point is lost the timer also
stops. The count down resumes once the
target temperature is reached again.
During the cool down cycle this display
counts up 0.5 minute to indicate the
duration of this cycle.
3.16. RF Time Display Displays the total time the RF has been
on in 1/10 of a minute resolution. This
display resets to zero at the onset of a
new treatment cycle. A treatment cycle
is considered to be complete if in the
previous cycle the Timer reached zero or
if TA mode was activated.
3.17. Impedance Display Displays the real time impedance value
of the tissue in ohms. The display shows
impedance range of 0-999U. When the
measured impedance is above 999 U, the
display shows OP.
3.18. Device Temperatures Displays the temperature readings of the
device thermocouples in whole units of
(degrees)C for temperatures between 15-
125(degrees)C. For temperatures below
15(degrees)C, LO is displayed. For
temperatures greater than 125(degrees)C
and less than 150(degrees)C, HI is
displayed. For temperatures above
150(degrees)C, OP is displayed. OP is
also displayed if there are no
thermocouples present in that location.
If all temperature channels measure OP,
this may indicate that the device is not
connected. In this case all temperature
displays remain blank. When HI is
displayed, or if OP is displayed as
result of temperature going above
150(degrees)C, the actual measured
temperatures are used for temperature
control algorithm.
3.19. Device Switches and LED's Each device temperature display has an
accompanying switch and a green LED. The
switch toggles the LED on and off. When
the LED is on, the reading of that
temperature sensor is used in the
temperature control algorithm. If the
LED is off, the displayed value is not
used in the calculation of the average
device temperature, or in determining
the highest or lowest measured
temperatures. The last sensor can not be
deselected in ATC mode. The sensors that
indicate OP prior to the activation of
RF are excluded from temp algorithm in
ATC mode and their LED's are OFF.
3.20. Auxiliary Temperatures Displays the temperature readings of the
thermocouples in the passive auxiliary
probe. The auxiliary probe has the same
features as in the device temperatures.
3.21. Aux Switches and LED's Functions similar to the switches and
LED's for the device temperature and
LED's.
3.22. LCD Display: A 40X2 character display used to inform
the user about the status of the
procedure
4. RS-232 Protocol: The format of the data string is 0XXXXXXX0XXXXXXX, with
the high bit for the start of packet signal. The protocol is 9600 baud, 8
bits, no parity, 1 stop bit. The 35 byte packet is formatted as follows:
Byte 0: 80(hex): bit 7 is the start of packet, bits 6-0 are the version
number
Byte 1: 00-7 F: counter, gets incremented by one with each packet then 127
wraps to 0
Byte 2: mode and status, 3 LO bits are mode, 0=power, 1 =ternp LO, 2=temp
AVG, 3=temp HI, bits 3 and 4 are status, 0=standby, 1 =ready, 2= RF ON
Bytes 9 & 10: RF time, 14 bit number, units are .10 seconds
Bytes 11 & 12: impedance, 14 bit number, units are .10 ohms
Bytes 13 through 24: device temps 1 through 6. 14 bits, .10 degree units
Bytes 25 & 26: aux temp 1, Bytes 27,28:aux temp2, Bytes 29 & 30: aux temp
3. 14 bits, .10 degree units
Bytes 31 & 32: temperature set point, 14 bits, .10 degree units
Byte 33: tool thermocouple (TC) selection, bits0 -5 represent TC 1-6, 0 =
OFF, 1 = ON
Byte 34: aux temp selection, bits 0-2 represent TC 1 -3, 0 = OFF, 1 = ON
Byte 35: Bits set to "1" if true else "0"
Bit 0 is set to 0, bit 1 is Track Ablation mode on, bit 2 is target
temp reached, bit 3 is target Temp lost, bit 4 is target temp not
reached, bit 5 is manual activation, bit 6 is cool down, and bit 7 is
RF interrupted.
Byte 36: Bits set to "1" if true else "0"
Bit 0 is set to 0, bit 1 is impedance too high, bit 2 is impedance too
low, bit 3 is heat sink temp too high, bit 4 is voltage test failure,
bit 5, 6, and 7 are set to zero.
Byte 37: 7 bit checksum, 00 - 7F computed by adding all previous bytes in
packet and using the 7 LSB's.
5. Operational Specifications (xxxxxx, refresh rate): The internal timer is
configured to generate an interrupt 100 times a second. This interrupt is
used to scan the front panel switches, feed the UART any data that is ready
to be sent out, update the procedure timer, and read the next thermocouple
(each device thermocouple and the cold junction compensation is read 10
times a second. The auxiliary probe temperatures are read 5 times a
second).
Every 10 times through the foreground loop checks the status of the
generator, updates the front panel, queues up a packet of data for the
serial port (from the processor buffer), resets and checks the watch dog
timer, and runs the RF generator loop. During RF generator loop device
impedance and split pad impedance are measured and RF power delivery is
controlled.
The thermocouple temperature displays, power delivered display, timer and
impedance readings are updated at a rate of once per second. Other
displays and LED's are updated in response to button presses and status of
the system.
6. Temperature Set Point Control: At the onset of RF energy delivery, the set
point temperature is first set to measured temperature. The set point is
then increased at the rate of 1(degrees)C per 2.5 seconds until the desired
set point temperature is reached.
7. Power Control and Power Ramp-Up: A proportional-derivative (PD) filter is
used to generate the change in power demand. The PD filter consists of a
proportional term, which is the difference between the desired temperature
and the actual temperature multiplied by a constant, and a derivative term,
which is the change in temperature error multiplied by a constant. The
proportional term forces the temperature towards the target temperature and
the derivative term provides damping. The demand is increased if the
change in error is increasing and the demand is decreased if the change in
error is decreasing.
8. Machine States:
The following defines the different states of the procedure:
. Power up and initial diagnostics
After initial diagnostic state "STANDBY Mode"
Automatic Temperature Control mode
Ready state, Automatic Temperature Control mode
Power Control mode
Ready state, Power Control mode
Track Ablation mode
Ready state, Track Ablation mode
RF Active, Automatic Temperature Control mode
Target Temperature Not Reached state
Manual Switch Activation state
. Target Temperature Reached state
. Target Temperature Lost state
. RF Active, Power mode
. Cool Down state
. After Cool Down state
. RF Active, Track Ablation mode
. RF Interrupted state
. Fatal Error state
. Soft Error state
8.1. Power Up and Initial Diagnostics:
In power up mode the following takes place:
8.1.1. LCD displays "SELF TEST, PLEASE WAIT
REV. X.XX"
8.1.2. The beep sounds continuously during the test
8.1.3. All segments of the LED displays light up for duration of test
8.1.4. All switches are disabled
8.1.5. RF LED turns on for the duration of the test
8.1.6. TA LED turns on for the duration of the test
8.1.7. After a successful completion of the test the system goes into
after initial diagnostic state
8.1.8. The following tests are performed during this period:
RAM Test: RAM test is the first power-up test. First the
external RAM and then the processor internal RAM are tested.
The test is composed of writing alternate 0's and l's in
selected addresses and verifying the contents.
ROM Test: This is done by calculating a 16 bit CRC for the low
and hi parts of the ROM.
Voltage Tests: +5V, +12V, -12V, and the high voltage (+36V)
are checked. Their values need to be within +/-10% of the
nominal.
Reference Impedance lest: The internal relays of the RF board
are switched to the I 00~ internal reference resistor. A few
xxxxx of RF energy are generated and put into this resistor.
The resistance is then
calculated by reading the current through and the voltage
across this resistor. The calculated value should be within
+/-10% of the reference resistor value of 100.
Heat Sink Temp Test: The temperature of the main transistor
heat sink has to be less than 50+5(degrees)C. If not the
-
actions of section 8.1.9 are taken. Once the temperature is
less than 50+5(degrees)C, the system exits the power-up test.
-
Temp Board Cal. Voltage Test: A reference voltage is read
through the temp measurement circuitry. This reading has to be
within 5% of nominal.
Ambient Temp Test: The cold-junction compensation sensor is
read. The measured temperature should be between 10-
40(degrees)C. If the measured temperature is outside the range
the appropriate action is taken as described in table of
section 8.1.9. Once the temperature is within the range, the
system exits the power-up test.
8.1.9. If the power up test fails the following happens. To recover,
the power needs to be cycled (turn OFF, then ON).
NOTE: Due to the nature of the failure, the expected the following
table may not result.
----------------------------------------------------------------------------------------------------------------------------
TEST BEEP LED SWITCHES RF TA LCD DISPLAY
DISPLAYS LED LED
----------------------------------------------------------------------------------------------------------------------------
RAM ON OFF Disabled OFF OFF "SYSTEM FAILURE 1 TURN
POWER OFF"
----------------------------------------------------------------------------------------------------------------------------
ROM ON OFF Disabled OFF OFF "SYSTEM FAILURE 2 TURN
POWER OFF CRC XXXXX"
----------------------------------------------------------------------------------------------------------------------------
Voltage ON OFF Disabled OFF OFF "SYSTEM FAILURE 3 TURN
POWER OFF"
----------------------------------------------------------------------------------------------------------------------------
Reference ON OFF Disabled OFF OFF "SYSTEM FAILURE 4 TURN
Impedance POWER OFF"
(lo limit test)
----------------------------------------------------------------------------------------------------------------------------
Reference ON OFF Disabled OFF OFF "SYSTEM FAILURE 5 TURN
Impedance (Hi POWER OFF"
limit test)
----------------------------------------------------------------------------------------------------------------------------
Heat Sink Temp ON 1 second Disabled OFF OFF "SYSTEM TEMP TOO HIGH"
----------------------------------------------------------------------------------------------------------------------------
Temp Board Cal. ON OFF Disabled OFF OFF "SYSTEM FAILURE 6 TURN
volt. test POWER OFF"
----------------------------------------------------------------------------------------------------------------------------
Temp Check ON 1 second OFF Disabled OFF OFF "AMBIENT TEMP OUT OF
RANGE"
----------------------------------------------------------------------------------------------------------------------------
8.2. "Standby" Mode:
8.2.1. LCD Displays `SELF TEST COMPLETE"
"PRESS RF ON/OFF SWITCH TO CONTINUE"
8.2.2. All displays are blank and LED's are OFF
8.2.3. All switches are disabled (except for RF ON/OFF)
8.2.4. Pressing RF ON/OFF puts system into automatic temp control
mode
8.3. Automatic Temperature Control Mode:
After successful power up and once RF switch is pressed1 the system
defaults to Automatic Temperature Control Mode average of all
temperatures as follows:
8.3.1 LCD displays " TEMP CONTROL: AVERAGE OF ALL"
8.3.2 If the device is not connected all device temperature LED's
are off.
8.3.3 If the device is plugged in all device sensors are showing the
current temperatures, their corresponding LED's are ON, and
their switches are enabled. If a device does not have all the
six sensors present, the position with no sensor displays OP,
their corresponding LED's are OFF, and the their switches are
disabled. The last LED can not be turned off (amongst the
active and passive probe sensors, at least one sensor needs to
be selected for the ATC).
8.3.4 The same applies for the passive probe temperature displays,
LED's, and switches. LED's are OFF by default.
8.3.5 RF LED flashes once a second.
8.3.6 RF switch is enabled.
8.3.7 TA LED is OFF.
8.3.8 TA switch is enabled.
8.3.9 Control Mode display shows A (under default condition), and
toggles through A, H, L, and P, sequentially. Every time the
mode is changed the buzzer beeps with a short burst.
8.3.10 The Set Temp display shows 100. The temp switches are enabled.
The switch with up arrow increments and the switch with a down
arrow decrements the setting in whole units of degree C. Every
time the setting is increased or decreased the change is
accompanied by a short burst from the buzzer. The temp can be
set between 50-120(degrees)C.
8.3.11 Power is defaulted to 150 xxxxx. The power set switches are
enabled. The switch with up arrow increments and the switch
with a down arrow decrements the setting in whole units of
watt. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
power can be set between 1-150 W.
8.3.12 The Timer displays 10.0. The switch with up arrow increments
and the switch with a down arrow decrements the setting in
units of 1/10 of a minute. Every time the setting is increased
or decreased the change is accompanied by a short burst from
the buzzer. The time can be set between 0-60.0 minutes. The
Manual Timer switch is disabled.
8.3.13 Power Delivered display shows 1.
8.3.14 RF Time display shows 0.0 or previously accumulated time.
8.3.15 Impedance display is live.
8.3.16 In Automatic Temperature control mode if the mode is changed
to L (Control on the lowest temp reading) or H (control on the
highest temperature reading) all the above applies with the
exception that the LCD display indicates " TEMP CONTROL:
LOWEST OF ALL" and
TEMP CONTROL: HIGHEST OF ALL", respectively.
8.4 Ready State Temp Control Mode:
When the procedure parameters are in the acceptable range, i.e.;
device impedance is in operating range, the system goes into the ready
mode and the LCD displays "READY TEMP CONTROL AVERAGE OF ALL", "READY
" TEMP CONTROL: LOWEST OF ALL" or "READY TEMP CONTROL: HIGHEST OF
ALL". All of the above conditions listed in section 8.3 apply.
8.5 Power Control Mode:
8.5.1 LCD displays " POWER CONTROL"
8.5.2 If the device is not connected all device temperature LED's are
off.
8.5.3 If the device is plugged in all the device sensors are showing
the current temperatures, their corresponding LED's are OFF,
and their switches are disabled. If a device does not have all
six sensors present, the position with no sensor displays OP.
8.5.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.5.5 RF LED flashes once a second.
8.5.6 RF switch is enabled.
8.5.7 TA LED is off.
8.5.8 TA switch is enabled.
8.5.9 Control Mode displays P, and can toggle through other modes (P,
A, H, and L) sequentially. Every time the mode is changed the
buzzer beeps with a short burst.
8.5.10 The Set Temp display is blank. The temp switches are disabled.
8.5.11 Power is defaulted to 1 watt. The power set switches are
enabled. The switch with up arrow increments and the switch
with a down arrow decrements the setting in whole units of
watt. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
power can be set between 1-150 W.
8.5.12 The Timer display shows 10.0. The switch with up arrow
increments and the switch with a down arrow decrements the
setting in units of 1110 of a minute. Every time the setting is
increased or decreased the change is accompanied by a short
burst from the buzzer. The time can be set between 0-60.0
minutes. The Manual Timer switch is disabled.
8.5.13 Power Delivered display shows 1.
8.5.14 RF Time display shows 0.0 or previously accumulated time.
8.5.15 Impedance display is live.
8.6 Ready State, Power Control Mode:
When the procedure parameters are in the acceptable range, i.e.;
device impedance is in operating range, the system goes into the ready
mode and the LCD displays "READY POWER CONTROL". All of the above
conditions listed in section 8.5 apply.
8.7 Track Ablation Mode:
Pressing the Track Ablation switch puts the system in Track Ablation
mode. The following happens:
8.7.1 LCD displays "TRACK ABLATION"
8.7.2 All device temperature LED's are off.
8.7.3 If the device is plugged in all the device sensors are showing
the current temperatures, their corresponding LED's are OFF,
and their switches are disabled. If a device does not have all
six sensors present, the position with no sensor displays OP.
8.7.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.7.5 RF LED flashes once a second.
8.7.6 RF switch is enabled.
8.7.7 TA LED flashes once a second.
8.7.8 TA switch is enabled.
8.7.9 Control Mode display shows C. The Control Mode switch is
enabled. Activation of Mode Select switch puts the system back
into the mode prior to selection of Track Ablation mode with
all the parameters preserved from the last setting. Every time
the mode is changed the buzzer beeps with a short burst.
8.7.10 The Set Temp display is blank. The Set Temp switches are
disabled.
8.7.11 Power is defaulted to 15 xxxxx. The Power Set switches are
enabled. The switch with up arrow increments and the switch
with a down arrow decrements the setting in whole units of
watt. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
power can be set between 1-25W.
8.7.12 The Timer display is blank. All three Timer switches are
disabled.
8.7.13 Power Delivered display shows 1.
8.7.14 RF Time display shows 0.0 or previously accumulated time.
8.7.15 Impedance display is live.
8.8 Ready State, Track Ablation Mode:
When the procedure parameters are in the acceptable range, i.e.;
device impedance is in operating range, the system goes into the ready
mode and the LCD displays "READY TRACK ABLATION". All of the above
conditions listed in section 8.7 apply.
8.9 RF Active, Automatic Temperature Control Mode:
8.9.1 Once the RF switch is activated, the system enters the RF
active state
LCD displays "RF ON TEMP CONTROL: AVERAGE OF ALL
HEATING TO TARGET TEMPERATURE"
Note:
For H and L modes, LCD displays:
"RF ON TEMP CONTROL: HIGHEST OF ALL
HEATING TO TARGET TEMPERATURE". , and
RF ON TEMP CONTROL: LOWEST OF ALL
HEATING TO TARGET TEMPERATURE". All other conditions apply.
8.9.2 The buzzer beeps for 1 second.
8.9.3 Device temperature displays are live and their switches are
enabled. The LED is ON for the selected sensors. If a device
does not have all the six sensors present, the position with no
sensor displays OP, their corresponding LED's are OFF, and the
their switches are disabled. The last LED can not be turned off
(amongst the active and passive probe sensors, at least one
sensor needs to be selected for the ATC).
8.9.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.9.5 RF LED is on.
8.9.6 Buzzer beeps with a short burst once every four seconds.
8.9.7 RF switch is enabled.
8.9.8 TA LED is off.
8.9.9 TA switch is disabled.
8.9.10 Control Mode displays A (under default condition), H, or L. The
control mode switch is disabled.
8.9.11 The Set Temp display shows the set temp. The temp switches are
enabled. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
temperature can be set between 50-120(degrees) C.
8.9.12 Power display shows the setting. The Power Set switches are
enabled. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
power can be set between 1-150 W.
8.9.13 The Timer display shows the set time. The switches are enabled.
Every time the setting is increased or decreased the change is
accompanied by
a short burst from the buzzer. The time can be set between 0-
60.0 minutes. The Manual Timer switch is enabled.
8.9.14 Power Delivered display is live.
8.9.15 RF Time display counts up in 1/10 minute increments.
8.9.16 Impedance display is live.
8.9.17 Once the target temperature is reaches the system enters the
TARGET TEMPERATURE REACHED state.
8.10. Target Temperature Not Reached State:
In ATC mode if the desired temp is not reached within 10 minutes from
the start of RF delivery the following happens:
8.10.1 LCD displays `READY TEMP CONTROL: AVERAGE OF ALL
TARGET TEMP NOT REACHED"
Note:
For H and L modes, the LCD displays:
"READY TEMP CONTROL: HIGHEST OF ALL
TARGET TEMP NOT REACHED". And,
"READY TEMP CONTROL: LOWEST OF ALL
TARGET TEMP NOT REACHED". All other conditions apply.
8.10.2 The buzzer beeps for 1 second.
8.10.3 Device temperature displays are live and their switches are
enabled. The LED is ON for the selected sensors. If a device
does not have all the six sensors present, the position with
no sensor displays OP, their corresponding LED's are OFF, and
the their switches are disabled. The last LED can not be
turned off (amongst the active and passive probe sensors, at
least one sensor needs to be selected for the ATC).
8.10.4 The same applies for the passive probe temperature displays,
LED1s, and switches.
8.10.5 RF LED flashes once a second.
8.10.6 RF switch is enabled.
8.10.7 TA LED is OFF.
8.10.8 TA switch is enabled.
8.10.9 Control Mode displays A (under default condition), H, or L.
The control mode switch is enabled.
8.10.10 The Set Temp display shows the set temp. The temp switches are
enabled. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
temperature can be set between 50-120(degrees)C.
8.10.11 Power Set display shows the setting. The power set switches
are enabled. Every time the setting is increased or decreased
the change is accompanied by a short burst from the buzzer.
The power can be set between 1-150W.
8.10.12 The Timer displays the set time. The switches are enabled.
Every time the setting is increased or decreased the change is
accompanied by a short burst from the buzzer. The time can be
set between 0-60.0 minutes. The Manual Timer switch is
disabled.
8.10.13 Power Delivered display shows 1.
8.10.14 RF Time display shows accumulated RF time and is frozen.
8.10.l5 Impedance display is live.
8.11 Manual Switch Activation state:
In ATC mode if the Manual Timer Switch is pressed the following
happens;
8.11.1 LCD displays "RF ON TEMP CONTROL: AVERAGE OF ALL MANUAL COUNT
DOWN ACTIVATED"
Note:
For H and L modes the LCD displays:
"RF ON TEMP CONTROL: HIGHEST OF ALL
MANUAL COUNT DOWN ACTIVATED". And,
"RF ON TEMP CONTROL: LOWEST OF ALL
MANUAL COUNT DOWN ACTIVATED". All other conditions apply.
8.11.2 The buzzer beeps for 1 second.
8.11.3 Device temperature displays are live and their switches are
enabled. The LED is ON for the selected sensors. If a device
does not have all the six sensors present, the position with
no sensor displays OP, their corresponding LED's are OFF, and
their switches are disabled. The last
LED can not be turned off (amongst the active and passive
probe sensors, at least one sensor needs to be selected for
the ATC).
8.11.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.11.5 RF LED is ON.
8.11.6 Buzzer beeps with a short burst once every four seconds.
8.11.7 RF switch is enabled.
8.11.8 TA LED is OFF.
8.11.9 TA switch is disabled.
8.11.10 Control Mode display shows A (under default condition), H or
L. The control mode switch is disabled.
8.11.11 The Set Temp display shows the set temp. The temp switches are
enabled. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
temperature can be set between 50-120(degrees) C.
8.11.12 Power display shows the setting. The power set switches are
enabled. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
power can be set between 1-150 W.
8.11.13 The Timer display counts down. The switches are enabled. Every
time the setting is increased or decreased the change is
accompanied by a short burst from the buzzer. The time can be
set between 0-60.0 minutes.
8.11.14 The Manual Timer switch is disabled.
8.11.15 Power Delivered display is live.
8.11.16 RF Time display is live and shows accumulated RF time.
8.11.17 Impedance display is live.
8.11.18 Once Timer counts down to zero the system goes into COOL DOWN
state.
8.12 Target Temperature Reached state:
In ATC mode, once the measured temperature is equal or greater than
the target temperature for 15 seconds the system enters the Target
Temperature Reached
state. The following happens:
8.12.1. LCD displays `RF ON TEMP CONTROL: AVERAGE OF ALL
TARGET TEMPERATURE REACHED"
Note:
For H and L modes, the LCD displays:
"RF ON TEMP CONTROL: HIGHEST OF ALL TARGET TEMPERATURE
REACHED". And,
"RF ON TEMP CONTROL LOWEST OF ALL
TARGET TEMPERATURE REACHED". All other conditions apply.
8.12.2 The buzzer beeps for 1 second.
8.12.3 Device temperature displays are live and their switches are
enabled. The LED is ON for the selected sensors. If a device
does not have all the six sensors present, the position with
no sensor displays OP, their corresponding LED's are OFF, and
the their switches are disabled. The last LED can not be
turned off (amongst the active and passive probe sensors, at
least one sensor needs to be selected for the ATC).
8.12.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.12.5 RF LED is ON.
8.12.6 Buzzer beeps with a short burst once every four seconds.
8.12.7 RF switch is enabled.
8.12.8 TA LED is OFF.
8.12.9 TA switch is disabled.
8.12.10 Control Mode displays A (under default condition), H or L. The
control mode switch is disabled.
8.12.11 The Set Temp display shows the set temp.
8.12.12 The Set Temp switches are enabled. Every time the setting is
increased or decreased the change is accompanied by a short
beep from the buzzer. The temp can be set from 50-
120(degrees)C.
8.12.13 Power display shows the setting. The Power Set switches are
enabled. Every time the setting is increased or decreased the
change is
accompanied by a short burst from the buzzer. The power can be
set between 1-150W.
8.12.14 The Timer display counts down. The switches are enabled. Every
time the setting is increased or decreased the change is
accompanied by a short burst from the buzzer. The time can be
set between 0-60.0 minutes.
8.12.15 The Manual Timer switch is disabled.
8.12.16 Power Delivered display is live.
8.12.17 RF Time display is live and shows accumulated RF time.
8.12.18 Impedance display is live.
8.12.19 Once Timer counts down to zero the system goes into COOL DOWN
state.
8.13 Target Temperature Lost state:
Once the target temperature is reached, if the measured temperature
drops below set temperature by more than 5(degrees)C for more than 15
seconds, the system enters Target Temperature Lost state. The
following happens:
8.13.1. LCD displays "RF ON TEMP CONTROL: AVERAGE OF ALL
TARGET TEMPERATURE LOST"
Note:
For H and L modes, the LCD displays:
"RF ON TEMP CONTROL: HIGHEST OF ALL
TARGET TEMPERATURE LOST", and
"RF ON TEMP CONTROL: LOWEST OF ALL
TARGET TEMPERATURE LOST". All other conditions apply.
8.13.2 The buzzer beeps for 1 second.
8.13.3 Device temperature displays are live and their switches are
enabled. The LED is ON for the selected sensors. If a device
does not have all the six sensors present, the position with
no sensor displays OP, their corresponding LED's are OFF, and
the their switches are disabled. The last LED can not be
turned off (amongst the active and passive probe sensors, at
least one sensor needs to be selected for the ATC).
8.13.4 The same applies for the passive probe temperature displays,
LED's and switches.
8.13.5 RF LED is ON.
8.13.6 Buzzer beeps with a short burst once every four seconds.
8.13.7 RF switch is enabled.
8.13.8 TA LED is OFF.
8.13.9 TA switch is disabled.
8.13.10 Control Mode displays A (under default condition) H, or L. The
control mode switch is disabled.
8.13.11 The Set Temp display shows the set temp. The Set Temp switches
are enabled. Every time the setting is increased or decreased
the change is accompanied by a short burst from the buzzer.
The temperature can be set between 50-120(degrees)C.
8.13.12 Power display shows the setting. The Power Set switches are
enabled. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
power can be set between 1-150W.
8.13.13 The Timer display shows the remaining time and is frozen. The
switches are enabled. Every time the setting is increased or
decreased the change is accompanied by a short burst from the
buzzer. The time can be set between 0-60.0 minutes. The Manual
Timer switch is enabled.
8.13.14 Power Delivered display is live.
8.13.15 RF Time display is live and shows accumulated RF time.
8.13.16 Impedance display is live.
8.13.17 If Temperature is not reached in 10 mm, system goes into
target temperature not reached state.
8.14 RF Active, Power Mode:
Once the RF switch is activated, the system enters the RF active
state:
8.14.1 LCD displays "RF ON POWER CONTROL"
8.14.2 The buzzer beeps for 1 second.
8.14.3 Device temperature displays are live and their switches are
disabled. The LED's are off for all the sensors. If a device
does not have all the six sensors present, the position with
no sensor displays OP.
8.14.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.14.5 RF LED is ON.
8.14.6 Buzzer beeps with a short burst once every four seconds.
8.14.7 RF switch is enabled.
8.14.8 TA LED is OFF.
8.14.9 TA switch is disabled.
8.14.10 Control Mode displays P. The control mode switch is disabled.
8.14.11 The Set Temp display is blank. The Set Temp switches are
disabled.
8.14.12 Set Power display shows the setting. The Power Set switches
are enabled. Every time the setting is increased or decreased
the change is accompanied by a short burst from the buzzer.
The power can be set between 1-150W.
8.14.13 The Timer display is live and counts down. The switches are
enabled. Every time the setting is increased or decreased the
change is accompanied by a short burst from the buzzer. The
time can be set between 0-60.0 minutes. The Manual Timer
switch is disabled.
8.14.14 Power Delivered display is live.
8.14.15 RF Time display counts up in 1/10 minute increments.
8.14.16 Impedance display is live.
8.15 Cool Down state:
In RF power delivery mode, once the Timer counts down to 0.0, the
system is entered into Cool Down mode for 30 seconds. The following
happens:
8.15.1 Depending on the mode, LCD displays:
"RF OFF TEMP CONTROL: AVERAGE OF ALL
COOL DOWN CYCLE" or,
"RF OFF TEMP CONTROL: HIGHEST OF ALL
COOL DOWN CYCLE" or,
"RF OFF TEMP CONTROL: LOWEST OF ALL
COOL DOWN CYCLE" or,
"RF OFF POWER CONTROL
COOL DOWN CYCLE"
8.15.2 The buzzer beeps for 1 second.
8.15.3 Device temperature displays are live and their switches are
disabled. The LED is ON for the selected sensors from the
previous RF active state (ATC mode). If a device does not have
all the six sensors present, the position with no sensor
displays OP, their corresponding LED's are OFF, and the their
switches are disabled. In power mode, the LED's are ON for
positions that are not OP.
8.15.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.15.5 RF LED flashes once a second.
8.15.6 RF switch is disabled.
8.15.7 TA LED is OFF.
8.15.8 TA switch is enabled.
8.15.9 Control Mode displays the previous mode. The control mode
switch is disabled.
8.15.10 The Set Temp display shows the set temp. The Set Temp switches
are disabled.
8.15.11 Power Set display shows the setting. The Power Set switches
are disabled.
8.15.12 The Timer display counts up from 0.0 to 0.5. The switches are
disabled. The Manual Timer switch is disabled.
8.15.13 Power Delivered display shows 1.
8.15.14 RF Time display shows accumulated RF time and is frozen.
Impedance display is live.
8.15.5 Impedance display is live.
8.16 After Cool Down State:
After the completion of the 30 second Cool Down the system enters the
After Cool Down state. The following happens:
8.16.1 Depending on the mode, LCD displays:
"READY TEMP CONTROL: AVERAGE OF ALL
COOL DOWN CYCLE COMPLETE" or,
"READY TEMP CONTROL: HIGHEST OF ALL
COOL DOWN CYCLE COMPLETE" or,
"READY TEMP CONTROL: LOWEST OF ALL
COOL DOWN CYCLE" or,
"READY POWER CONTROL
COOL DOWN CYCLE COMPLETE"
8.16.2 The buzzer beeps for 1 second.
8.16.3 Device temperature displays are live and their switches are
enabled. The LED is ON for the selected sensors. If a device
does not have all the six sensors present, the position with
no sensor displays OP, their corresponding LED's are OFF, and
the their switches are disabled. (In power mode the switches
are disabled and the LED's are off)
8.16.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.16.5 RF LED flashes once a second.
8.16.6 RF switch is enabled.
8.16.7 TA LED is off.
8.16.8 TA switch is enabled.
8.16.9 Control Mode displays the previous mode. The control mode
switch is enabled.
8.16.10 The Set Temp display shows the previous set temp (for P mode
it is blank and switches are disabled). The Set Temp switches
are enabled.
8.16.11 Power display shows the previous setting. The Power Set
switches are enabled.
8.16.12 The Timer display shows the previous set time. The Timer
switches are enabled. The Manual Timer switch is disabled.
8.16.13 Power Delivered display shows 1.
8.16.14 RF Time display shows accumulated RF time. The time resets to
zero at the onset of the next treatment cycle.
8.16.15 Impedance display is live.
8.17 RF Active, Track Ablation Mode:
When in TA mode, pressing the RF switch puts the system in this mode:
8.17.1 LCD displays "RF ON TRACK ABLATION"
8.17.2 All device temperature LED's are OFF.
8.17.3 Temp displays show the current temperatures, and their
switches are disabled. If a device does not have all six
sensors present, the position with no sensor displays OP.
8.17.4 The same applies for the passive probe temperature displays,
LED's, and switches.
8.17.5 RF LED is ON.
8.17.6 Buzzer gives two consecutive short beeps every one second.
8.17.7 RF switch is enabled.
8.17.8 TA LED is ON.
8.17.9 TA switch is enabled (turns RF OFF).
8.17.10 Control Mode display shows C. The Control Mode switch is
disabled.
8.17.11 The Set Temp display is blank. The Set Temp switches are
disabled.
8.17.12 Set Power display indicates the setting. The power set
switches are enabled. The switch with up arrow increments
and the switch with a down arrow decrements the setting in
whole units of watt. The power can be set between 1-25W.
8.17.13 The Timer display is blank. Timer switches are disabled.
8.17.14 Manual Timer switch is disabled.
8.17.15 Power Delivered display is live.
8.17.16 RF Time display shows the accumulated time and is frozen.
8.17.17 Impedance display is live.
8.18 RF Interrupted State:
8.18.1 RF Interrupted, Track Ablation state:
During the RF ON Track Ablation state, if the RF switch or
the TA switch is pressed the LCD displays:
"READY TRACK ABLATION
RF WAS TURNED OFF"
and the system goes into System Ready, Track Ablation state.
However, the power setting is the previous setting and not
the default setting of 15 Xxxxx.
8.18.2 RF Interrupted state, Power Control mode:
During RF delivery if the RF switch is pressed the RF
delivery is interrupted. In Power Control mode the following
happens:
8.18.2.1 LCD displays:
"READY POWER CONTROL"
RF WAS TURNED OFF"
8.18.2.2 Device sensors are showing the current
temperatures, their corresponding LED's are OFF,
and their switches are disabled. If a device
does not have all six sensors present, the
position with no sensor displays OP.
8.18.2.3 The same applies for the passive probe
temperature displays, LED's, and switches.
8.18.2.4 RF LED flashes once a second.
8.18.2.5 RF switch is enabled.
8.18.2.6 Track Ablation LED is off.
8.18.2.7 Track Ablation switch is enabled.
8.18.2.8 Control Mode displays P, and the Control Mode
switch is enabled.
8.18.2.9 The Set Temp display is blank. The temp switches
are disabled.
8.18.2.10 Power display shows the previous set power. The
power set switches are enabled. The power can be
set between 1-150 W.
8.18.2.11 The Timer display shows the remaining time and
is frozen. The Timer switches are enabled. The
Manual Timer switch is disabled.
8.18.2.12 Power Delivered display shows 1.
8.18.2.13 RF Time display shows accumulated RF time and is
frozen.
8.18.2.14 Impedance display is live.
8.18.3 RF Interrupted state, ATC Mode:
In ATC mode (A, H, or L), when RF delivery is interrupted the
following happens:
8.18.3.1 Depending on the mode, the LCD displays:
"READY TEMP CONTROL: AVERAGE OF ALL RF WAS TURNED
OFF"
"READY TEMP CONTROL: HIGHEST OF ALL RF WAS TURNED
OFF"
"READY TEMP CONTROL: LOWEST OF ALL RF WAS TURNED
OFF"
8.18.3.2 All the device sensors are showing the current
temperatures, their corresponding LED's on the
selected sensors are ON. Temp switches are enabled.
If a device does not have all the six sensors
present, the position with no sensor displays OP,
their corresponding LED's are OFF, and the their
switches are disabled. The last LED can not be
turned off (amongst the active and passive probe
sensors, at least one sensor needs to be selected
for the ATC).
8.18.3.3 The same applies for the passive probe temperature
displays, LED's, and switches.
8.18.3.4 RF LED flashes once a second.
8.18.3.5 RF switch is enabled.
8.18.3.6 Track Ablation LED is OFF.
8.18.3.7 Track Ablation switch is enabled.
8.18.3.8 Control Mode display shows A, H, or L. The mode
switch is enabled.
8.18.3.9 The Set Temp display shows the set temperature. The
Set Temp switches are enabled.
8.18.3.10 Power Set shows the previous power setting. The
Power Set switches are enabled.
8.18.3.11 The Timer displays the remaining time. The Timer
switches are enabled. The Manual Timer switch is
disabled.
8.18.3.12 Power Delivered display shows 1.
8.18.3.13 RF Time display shows the accumulated RF time and
is frozen.
8.18.3.14 Impedance display is live.
8.19 Fatal Error State:
A Fatal Error State is a state caused by a system failure at any time
after the completion of the initial power-up test. The system can
only recover by cycling the power. The following tests are performed:
Hardware Watch Dog Timer: Every 0.25 second the processor refreshes
the watch dog. If this does not happen the RF is disabled. The watch
dog status is checked once a second. If the watch dog is tripped, the
system halts.
Voltage Check: The internal voltages are checked once a second as
described in sections 8.1.8 and 8.1.9.
Foreground Loop Test: The foreground loop has to be completed before
it can be run again.
Temp Board Cal. Voltage Test: The Ref voltage through temp signal
processing circuitry is read once a second.
Under this condition the following happens:
NOTE: Due to the nature of the failure, the expected outcome
outlined below may not result
8.19.1 LCD displays "SYSTEM FAILURE X TURN POWER OFF"
(Where X is 3 for voltage test and 6 for temp cal. voltage test)
8.19.2 All device temperature LED's are OFF.
8.19.3 Device temperature displays are blank, and their switches are
disabled.
8.19.4 Passive probe temperature displays are blank. Their LED's are
OFF and switches are disabled.
8.19.5 RF LED is OFF.
8.19.6 Buzzer beeps continuously.
8.19.7 RF switch is disabled.
8.19.8 Track Ablation LED is OFF.
8.19.9 Track Ablation switch is disabled.
8.19.10 Control Mode display is blank. The control mode switch is
disabled.
8.19.11 The Set Temp display is blank. The temp switches are
disabled.
8.19.12 Set Power display is blank. The Power Set switches are
disabled.
8.19.13 The Stop Timer display is blank. All three Stop Timer
switches are disabled.
8.19.14 Power Delivered display is blank.
8.19.15 RF Time display is blank.
8.19.16 Impedance display is blank.
8.20 Soft Error State: At the completion of the power up test, in
addition to the tests mentioned in section 8.19, the system
routinely monitors the device impedance and heat sink temperature.
The output current is also monitored and is limited to 3.5 Amps by
adjusting the output power. This action is internally controlled and
does not result in any prompts.
8.20.1 Impedance Out of Range state:
If impedance is out of the allowable range, prior to
delivery of RF energy, activation of RF switch keeps the
system in the current mode. Additionally the buzzer beeps
with three half second beeps and on the second line of the
LCD display "IMPEDANCE TOO HIGH" or "IMPEDANCE TOO LOW" is
displayed (any existing text on the second line is replaced
with the impedance too high or too low message). In this
state once the impedance measurement is within the
operational range, the impedance too high or too low
message is removed from the second line of the LCD and the
buzzer beeps once for one second. If correcting the
impedance out of range issue makes the system ready for RF
delivery, the system goes directly into ready state and the
impedance too high or too low message is removed. The
acceptable impedance range in all modes is 10-999U.
If impedance goes out of the allowable range during RF
delivery, the system remains in the current mode with the
LCD displaying "RF OFF" on the first line along with the
mode display. Additionally on the second line of the LCD
"IMPEDANCE TOO HIGH" or "IMPEDANCE TOO LOW" is displayed
(any existing text on the second line is replaced with the
impedance too high or too low message). The buzzer gives
three half second beeps. In this mode once the impedance
measurement is within the operational range, the "RF OFF"
in the first line is replaced with "READY" and the buzzer
beeps once for one second. The second line remains until RF
is activated or if the mode is changed.
8.20.2 Heat Sink Temperature Test:
After the completion of the initial power-up tests, the
temperature of the heat sink is routinely measured. If the
temperature is above 60(degrees)C the system remains in
the current mode with the LCD displaying "RF OFF" on the
first line along with the mode display. Additionally on the
second line of the LCD "SYSTEM TEMP TOO HIGH" is displayed
(any existing text on the second line is replaced with the
system temp too high message). The buzzer gives three half
second beeps. In this mode once the temperature of the heat
sink is less than 50(degrees)C the "RF OFF" in the first
line is replaced with "READY" and the buzzer beeps once for
one second. The second line of the LCD will be blank.
MASTER DOCUMENT PREPARATION VERIFIED BY:________________________________________
DATE:________________________
