exv10w6






Exhibit 10.6










Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.









Amendment 2

OEM DEVELOPMENT AND PURCHASE AGREEMENT



This Amendment 2 to the OEM Development and Purchase Agreement dated the 24th day of
July, 2003, as amended by Addendum 1 (with a date of June 5, 2006 in the footer of such document)
(the “Agreement”), by and between Aspect Medical Systems, Inc. (“Aspect”) and Mindray DS USA, Inc.
(“Datascope”) (formerly Datascope Corp.) is made as of this 3rd day of October, 2009
(the “Amendment Effective Date”).



Terms used, but not defined, in this Amendment 2, have the meaning ascribed to them in the
Agreement.





	 	1.	 	Section 2 of the Agreement shall be replaced by the following:






	 	2	 	Definitions
	 
	 	2.1	 	“Affiliate” shall mean, with respect to either Aspect or
Datascope, any other business entity which, directly or indirectly, controls, is
controlled by, or is under common control with Aspect or Datascope, respectively.
The parties agree and acknowledge that Mindray and its affiliates are Affiliates
of Datascope.
	 
	 	2.2	 	“Aspect BIS Sensor” means a single use disposable sensor
manufactured by Aspect for use with the Aspect BISx Kit in the OR, ICU, and other
sedation locations that is required to generate Aspect’s Bispectral Index. These
sensors include the BIS Quatro Sensor, the BIS Bilateral Sensor and the BIS
Pediatric Sensor.
	 
	 	2.3	 	“Aspect’s Bispectral Index” or “BIS” is Aspect’s
proprietary processed EEG parameter that may be used as an aid in monitoring the
effects of certain anesthetic agents.
	 
	 	2.4	 	“Aspect BISx Kit” is the Aspect components of the Datascope
BISx System that are developed and manufactured by or for Aspect and licensed/sold
to Datascope under this Agreement including the BISx or BISx4, and the Patient
Interface Cable (“PIC”).
	 
	 	2.5	 	“Aspect Products” means Aspect BISx Kit and any other product
that can be ordered by Datascope as listed in Exhibit A (Aspect Products and
Purchase Prices).
	 
	 	2.6	 	“BISx” is an Aspect device that acquires up to two channels of
EEG and computes BIS and other EEG parameters.
	 
	 	2.7	 	“BISx4” is an Aspect device that acquires up to four channels
of EEG and computes BIS and other EEG parameters
	 
	 	2.8	 	“Documentation” means the BISx Serial Interface Specification.
	 
	 	2.9	 	“Monitor Cable” is a cable that connects the BISx or BISx4 to
the Datascope Patient Monitor.
	 
	 	2.10	 	“Host Cable Connector” is the connector that is or will be (as
applicable) integrated into the Monitor Cable for connection to the Datascope
Patient Monitors.




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	 	2.11	 	“Datascope Patient Monitors” includes but not limited to
multiparameter patient monitoring systems and anesthesia machines manufactured
and/or sold by Datascope or its Affiliates under the Datascope brands designed for
monitoring patient vital signs in anesthetizing and sedating locations.
	 
	 	2.12	 	“Datascope BISx System” is the combined Aspect BISx Kit and
Monitor Cable.
	 
	 	2.13	 	“Party” or “Parties” shall mean Aspect and Datascope
each individually or jointly.
	 
	 	2.14	 	“Software” means Aspect software programs in binary code form
that are designed for use with the Aspect BISx Kit.
	 
	 	2.15	 	“Mindray” means Shenzen Mindray Bio-Medical Electronics Co.,
Ltd.






	 	2.	 	Section 4.3 of the Agreement shall be replaced by the following:
	 
	 	 	 	Distribution of Aspect BIS Sensors






	 	4.3.1	 	Sensor Distribution
	 
	 	 	 	Aspect will provide Datascope one (1) starter kit of demonstration sensors
(five (5) sensors per kit as set forth in Exhibit A (Aspect Products and
Purchase prices)), at no charge with each Datascope BISx System purchased.
Datascope will provide this starter kit of five (5) Aspect BIS Sensors at
no charge with each Datascope BISx System sold to the customer purchasing
the corresponding Datascope BISx System.
	 
	 	 	 	Datascope may [**] of Aspect BIS Sensors (twenty-five (25) sensors per
box, except for Bilateral which is ten (10) sensors per box, as set forth
in Exhibit A) solely in connection with the new sale of each Datascope
BISx System and solely to the customer purchasing the corresponding
Datascope BISx System. Sensors are to be delivered at time of Datascope
BISx System installation.
	 
	 	4.3.2	 	Prices
	 
	 	 	 	Prices for Aspect BIS Sensors purchased by Datascope hereunder shall be as
set forth in Exhibit A (Aspect Products and Purchase Prices).




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	 	4.3.3	 	Aspect will ensure that Datascope customers have an outlet
(which may include Aspect or its Affiliates or a third party distributor) from
which to purchase BIS Sensors.  In the event Aspect does not provide such an
alternative BIS Sensor outlet in a country or region, Aspect (or its local
Affiliate) will grant Datascope or the applicable Datascope local Affiliate
non-exclusive distribution rights for BIS Sensors to Datascope customers in
such country or region with terms, conditions and pricing consistent with
those of similar distributors in other countries or regions offering the same
level of marketing, customer, and technical support as the local Datascope
Affiliate is prepared to offer.  Aspect shall have the right to terminate any
such agreement upon three (3) months notice once Aspect has established an
alternative BIS Sensor outlet for such country or
region. Aspect will provide regular updates to Datascope regarding the
progress toward the establishment of alternative BIS Sensor outlets.
	 
	 	4.3.4	 	If any sales by Datascope or its Affiliates, distributors or
sub-distributors of BIS Sensors are made to any customer in contravention of
Section 4.3.1, Datascope will cease such sales and Datascope will
retroactively pay Aspect an [**] for every BIS Sensor previously sold to
customers in contravention of Section 4.3.1. In addition, Datascope shall
reimburse Aspect for the cost of any audit that confirmed the existence of any
such sales.






	 	3.	 	Section 6.1 “Commissions on Sales of Aspect BIS Sensors” is deleted
	 
	 	4.	 	Section 7.6 “Competitive Products and Volume Price Discounts “ is added:
	 
	 	 	 	Competitive Products and Volume Price Discounts
	 
	 	 	 	If Datascope or its Affiliates offer a directly competitive product to the Aspect
BISx Kit (any parameter that utilizes EEG to measure the hypnotic effect of
anesthesia) the volume discounts shown in Exhibit A [**].
	 
	 	5.	 	The following is added to the end of Section 10 of the Agreement:
	 
	 	 	 	In the event that a new Datascope BISx System (not repaired or refurbished product)
is rejected by Datascope, and Aspect replaces the product as remedy, the
replacement product shall be a new Datascope BISx System, not refurbished.
	 
	 	 	 	In the event that Datascope rejects a service exchange Datascope BISx System, and
Datascope provides written notice to Aspect of the rejection within [**] days of
the date of receipt, Aspect shall in good faith, promptly upon receipt of written
notification, and in lieu of return receipt of the rejected service exchange
Datascope BISx System, send to Datascope a replacement service exchange Datascope
BISx System. Should Aspect’s subsequent examination and testing of the rejected
service exchange Datascope BISx System disclose that there was no defect covered by
the warranty set forth in Section 10, Aspect shall so advise Datascope and Aspect
may dispose of or otherwise handle the returned service




3/15









 






	 	 	 	exchange Datascope BISx
System at Aspect’s discretion, and Datascope shall reimburse Aspect for
transportation and insurance costs.




4/15









 












	 	6.	 	Section 11.1 of the Agreement shall be replaced by the following:
	 
	 	 	 	General
	 
	 	 	 	Aspect warrants solely to Datascope that Aspect Products (including Software)
delivered hereunder shall perform substantially in accordance with the
specifications in Exhibit B (Datascope’s BISx System) and shall be free from
defects in materials and workmanship, when given normal, proper and intended usage,
for [**] months from the date of shipment by Aspect to Datascope. This warranty
shall not apply to expendable components and supply items, such as, but not limited
to, cables (except for failures occurring within [**] days of receipt of shipment
by Datascope), or disposable items such as an Aspect BIS Sensor after the
expiration date marked on the Aspect BIS Sensor packaging. Aspect shall not have
any obligation under this Agreement to make repairs or replacements which are
required by normal wear and tear, or which result, in whole or in part, from
catastrophe, fault or negligence of Datascope or Affiliate, or anyone claiming
through or on behalf of Datascope, or from improper or unauthorized use of Aspect
Products, or use of Aspect Products in a manner for which they were not designed,
or by causes external to Aspect Products such as, but not limited to, power or air
conditioning failure.
	 
	 	7.	 	Section 11.2 of the Agreement shall be replaced by the following:
	 
	 	 	 	Warranty Procedures
	 
	 	 	 	Datascope shall notify Aspect of any Aspect products which it believes to be
defective during the applicable warranty period and which are covered by the
warranties set forth in Section 11.1. At Aspect’s option, such Aspect Products
shall be returned by Datascope to Aspect’s designated facility for examination and
testing, or may be repaired on site by Aspect. Aspect shall either repair or
replace, within [**] of receipt by Aspect, any such Aspect Product found to be
defective and return these Aspect Products to Datascope. Transportation and
insurance costs shall be borne by Aspect. Should, Aspect’s examination and
testing disclose that there was no defect covered by the foregoing warranty, Aspect
shall so advise Datascope and dispose of or return the Aspect Product in accordance
with Datascope’s instructions and at Datascope’s expense, and Datascope shall
reimburse Aspect for transportation and insurance costs.
	 
	 	8.	 	Section 12.2 of the Agreement shall be replaced by the following:
	 
	 	 	 	Service Training
	 
	 	 	 	Aspect agrees to provide initial service training, [**] to Datascope, to a mutually
agreed upon number of Datascope service representatives prior to the market release
of the BISx Systems
	 
	 	 	 	If there are Aspect Product changes that materially affect form, fit, or function,
as described in Section 15, and based on the mutual understanding of the necessity
of the training, Aspect shall provide [**] training to a mutually agreed upon
number of Datascope personnel, at a mutually agreed upon schedule, [**] to
Datascope.




5/15









 












	 	9.	 	Section 14.7 of the Agreement shall be replaced by the following
	 
	 	 	 	Recall
	 
	 	 	 	In the event that a corrective action (including notifications or recalls) is
initiated with respect to any Aspect Product, and such action (i) is required to
comply with applicable laws or regulations, (ii) is initiated by Aspect in its
discretion for a reasonable business purpose or for safety reasons or (iii) is the
result of the failure of Aspect Products to conform in all material respects to the
applicable standards, Aspect shall be responsible for the repair or replacement of
the Aspect Products without cost to Datascope. Aspect agrees to consult with
Datascope to establish a reasonable process for managing the corrective action and
Aspect shall be responsible for all reasonable out-of-pocket expenditures incurred
by Datascope if Aspect fails to take corrective action. In the event that Aspect
or Datascope is required to take such action to comply with applicable laws or
regulations or such action is reasonably necessary for safety and efficacy reasons
or for the failure of the Aspects Products to comply with specifications (other
than minor deviations from specifications) and fails to do so within 10 days of
being notified of the need for such action, Datascope shall have the right to take
such action and Aspect shall reimburse Datascope for all reasonable out-of-pocket
expenditures incurred in connection with such action by Datascope. If it is
determined by an arbitrator that such action was not necessary for safety reasons
or for the failure of Aspect Products to comply with specifications (other than a
minor deviation from such specifications), Datascope will return to Aspect any
amounts previously paid to Datascope by Aspect in connection with such action.
	 
	 	 	 	Any corrective action will be at Datascope’s expense if clearly caused by the
Datascope Patient Monitor. Datascope will reimburse Aspect for Aspect’s documented
cost directly resulting from such corrective actions within sixty (60) days of
completion of the corrective action.
	 
	 	 	 	Datascope and Aspect will share the cost if both Parties’ products contribute to
the cause, proportionate to the extent of each Party’s respective degree of cause
as mutually agreed. Aspect and Datascope will negotiate in good faith a reasonable
settlement of the issue. If after twenty (20) business days, the Parties in good
faith fail to agree the issue will be escalated for resolution in accordance with
Section 22.
	 
	 	10.	 	Section 22.1 of the Agreement shall be replaced by the following
	 
	 	 	 	Term and Renewal
	 
	 	 	 	The initial term of this Agreement shall commence on the date first set forth above
and shall continue for an initial period until October 25, 2009. The term of this
Agreement shall thereafter be renewed automatically for successive twelve (12)
month periods, unless either Party provides written notice of termination to the
other Party at least ninety (90) days prior to expiration of the Agreement.
	 
	 	11.	 	Exhibits of the Agreement shall be replaced as follows:






	 	a)	 	“Exhibit A: Aspect Products and Purchase Prices” is replaced
by the attached “Exhibit A: Aspect Products and Purchase Prices”.




6/15









 













	 	b)	 	“Exhibit B: Specifications: Datascope BISx System” is
replaced by the attached “Exhibit B: Specification: Datascope BISx System”.
	 
	 	c)	 	“Exhibit C: Contact Persons / Addresses” is replaced by the
attached “Exhibit C: Contact Persons / Addresses”.
	 
	 	d)	 	“Exhibit D: Aspect and Datascope Trademarks” is replaced by
the attached “Exhibit D: Aspect and Datascope Trademarks”.




All terms and conditions of the Agreement not modified herein shall remain unchanged, in full force
and effect. After the Amendment Effective Date, every reference in the Agreement to the
“Agreement” shall mean the Agreement as amended by this Amendment 2.



Acceptance of this Amendment 2 is indicated by signatures below.




	 	 	 	 	 	 	 	 	 
	Aspect Medical Systems, Inc.	 	Mindray DS USA, Inc.	 	 
	 
	By:

	 	/s/ J. Neal Armstrong	 	By:	 	/s/ Tim Fitzpatrick	 	 
	 

	 	 

	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 
	Date:

	 	11-5-09	 	Date:	 	2 November 2009	 	 
	 

	 	 

	 	 	 	 

	 	 
	 
	 	 	 	 	 	 	 	 
	Name:

	 	Neal Armstrong
	 	Name:	 	Tim Fitzpatrick	 	 
	Title:

	 	Chief Financial Officer
	 	Title:	 	Corporate Secretary	 	 






7/15









 






EXHIBIT A




ASPECT PRODUCTS AND PURCHASE PRICES




A) Datascope BISx System:




	 	 	 	 	 	 	 	 	 	 	 	 	 	    	 	 	 
	Aspect	 	Datascope	 	 	 	 	 	Unit of	 	 
	Part Number	 	Part Number	 	Product Description	 	Measure	 	List Price
	186-0195-DS
	 	0992-00-0236-01	 	 	BISx Kit  (Datascope)	 	1 each	 	[**]	 
	186-0224-DS
(†)
	 	TBD	 	 	BISx4 Kit  (Datascope)	 	1 each	 	[**]	 








 




			
	(†)	 	Estimated price, assumes a standard Datascope monitor cable and host cable connector.
Customization of monitor cable or host cable connector may increase costs. BISx4 Kit development
costs will be determined by the terms and conditions of Section 7 the Agreement.





B) Volume Discounts




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Total Price for	 	Total Price for
	Cumulative Annual Total	 	 	 	 	 	 	 	 	 	Price for	 	Datascope BISx	 	Datascope BISx4
	Volume (in units) ‡	 	Price for	 	Price for	 	Monitor	 	System	 	System
	(Calendar Year)	 	BISx Kit	 	BISx4 Kit	 	Cable	 	186-0195-DS	 	186-0224-DS(†)
	[**]
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	[**]
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	[**]
	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 








 




			
	(†)	 	Estimated price, assumes a standard Datascope monitor cable and host cable connector.
Customization of monitor cable or host cable connector may increase costs. BISx4 Kit development
costs will be determined by the terms and conditions of Section 7 the Agreement.
	 
	‡	 	Total calculation includes all Datascope BISx System types purchased by Datascope under this
Agreement (186-0195-DS and BISx4 Kits), as well as [**]. Cumulative means the combination of
volume of Mindray and [**].  Pricing from the Amendment Effective Date through [**] will be at the
[**] level. Pricing for subsequent years will be as defined in section E of this Exhibit A.





C) BIS DISPOSABLE SENSORS




	 	 	 	 	 	 	 	 	 	 	 	 	 	   	 	 	 
	Aspect	 	Datascope	 	 	 	 	 	Unit of	 	Datascope
	Part Number	 	Part Number	 	Product Description	 	Measure	 	Price
	186-0106*
	 	0600-00-0132-01	 	 	BIS Quatro Sensor	 	Box of 25	 	[**]	 
	186-0200*
	 	0600-00-0132-03	 	 	BIS Pediatric Sensor	 	Box of 25	 	[**]	 
	186-0160*
	 	0600-00-0132-02	 	 	BIS Extend Sensor	 	Box of 25	 	[**]	 
	186-0212*
	 	TBD	 	BIS Bilateral Sensor	 	Box of 10	 	[**]	 








 




			
	*	 	Datascope may distribute [**] of sensors (1 box = 25 sensors, except for Bilateral where 1 box =
10 sensors) bundled with the sale of the Datascope BISx System, as set forth in Section 4.3.





     ii) Demonstration sensors:



	 	 	 	 	 	 	 	 	 
	Aspect	 	Datascope	 	 	 	Unit of	 	Datascope
	Part Number	 	Part Number	 	Product Description	 	Measure	 	Price
	186-0150-DS**

	 	0020-00-0491-01
	 	BIS Quatro Starter Kit
	 	Box of 5
	 	[**]
	186-0206-DS**

	 	0020-00-0491-03
	 	BIS Pediatric Starter Kit
	 	Box of 5
	 	[**]








 




			
	**	 	Demonstration sensors cannot be resold




8/15









 










D) SPARE PARTS/ACCESSORY PRICES




	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Datascope	 	Orderable	 	Unit of	 	Aspect	 	Datascope
	Aspect Part #	 	Part Number	 	Parts/Products	 	Measure	 	List Price	 	Price
	186-0142-DS

	 	0012-00-1666-01
	 	DS PIC+ Cable

(replacement)
	 	1 each
	 	$	125.00	 	 	[**]
	186-0201-DS

	 	0012-00-1665-01
	 	Datascope Host Cable

(Replacement)
	 	1 each
	 	 	 	 	 	[**]
	186-1018-DS

	 	TBD
	 	DS PIC4 Cable

(replacement)
	 	1 each
	 	$	200.00	 	 	[**]
	186-0143-DS

	 	0454-00-0060
	 	DS 2ch & 4ch Sensor

Simulator
	 	1 each
	 	$	30.00	 	 	[**]






	 	 	 	 	 	 	 	 	 	 	 	 	 
	Aspect Part	 	Datascope	 	Orderable	 	Unit of	 	Aspect	 	Datascope
	Number	 	Part Number	 	Parts/Products	 	Measure	 	List Price	 	Price
	186-0199-DS (••)

	 	0992-UC-0236-01
	 	Datascope BISx Kit

(service exchange)
	 	1 each
	 	$	1,500.00	 	 	[**]
	186-1030-DS (†) (••)

	 	TBD
	 	Datascope BISx4 Kit

(service exchange)
	 	1 each
	 	$	2,300.00	 	 	[**]








 




			
	(†)	 	Estimated price, assumes a standard Datascope monitor cable and host cable connector.
Customization of monitor cable or host cable connector may increase costs. BISx4 Kit development
costs will be determined by the terms and conditions of Section 7 the Agreement.
	 
	(••)	 	Service exchange items may be refurbished product. Service exchange items can only be
ordered in qty equal to Return Material Authorization Numbers (RMA#s) issued by Aspect.
See Section 11.2 of the Agreement for details on Warranty procedures. Units exchanged under
warranty may be replaced with a comparable refurbished product and carry a Repair Warranty as
outlined in Section 11.3 of the Agreement.





E) CALCULATION OF VOLUME DISCOUNT:





For the purpose of calculating the volume discount for a given calendar year, all BISx/BISx4
Kits purchased by [**], excluding Aspect Products that are shipped free of charge, will be
included in the total volume discount calculation.




The initial pricing for a given calendar year is based on the total volume of BISx/BISx4 Kits
purchased in the prior calendar year. For example, if [**] BISx Kits were purchased in year 1,
the initial volume pricing level for year 2 will be the [**] unit price level. The Parties
agree that, for the period beginning on the Amendment Effective Date and continuing through
[**], pricing will start at the [**] unit price level.




If a higher volume level of BISx/BISx4 Kits is achieved during a given calendar year, the price
on only those BISx/BISX4 Kits purchased after achieving the higher volume level will reflect
the price associated with the appropriate volume level achieved. All price adjustments will
apply on a going forward basis only. For example, if midway through year 2, [**] BISx Kits are
purchased, the price on the [**] BISx Kit will reflect the next volume break.



     F) CURRENCY




United States Dollars



9/15









 





EXHIBIT B

SPECIFICATIONS: DATASCOPE BISx SYSTEM










PRODUCT DESCRIPTION




The BISx Kit includes a PIC+, BISx Device, and a Monitor Cable. The BISx kit will here
forth be referred to as BISx. The BISx4 Kit includes a 4 channel PIC, BISx4 Device, and a
Monitor Cable. The BISx4 kit will here forth be referred to as BISx4.




BISx is a device that acquires up to two channels of EEG and computes BIS and other EEG
parameters. BISx4 is a device that acquires up to four channels of EEG and computes BIS
and other EEG parameters. Both the BISx and BISx4 are designed to mate with Aspect’s XP
platform 1 or 2 channel sensors. The BISx4 is designed to additionally interface with
Aspect’s Bilateral sensor, which is required for acquisition of 4 channels of EEG. BISx
and BISx4 have no display or user interface. They plug into a host monitor system for
display of EEG and processed parameters. BISx and BISx4 are designed for use wherever
sedative drugs are administered, including but not limited to the following environments:
Operating rooms, Intensive Care Units, Procedural Sedation, and Clinical Research areas.




BISx and BISx4 interface to one or more of the following interfaces: standard RS-232
asynchronous interface, RS-232 type asynchronous interface but with TTL 3.3V signal levels,
RS-485, or Universal Serial Bus (USB) interface. All interface versions also support USB
interfacing for software upgrade and download purposes. BISx and BISx4 can be connected
and disconnected to an already powered up host monitor. The host monitor should
automatically detect its presence and configure it accordingly.



10/15









 






The BISx connects to a sensor via the Aspect Patient Interface Cable (here forth referred
to as PIC+). The PIC+ is nominally 4.5 ft. long. The PIC+ connection is integral to the
enclosure (no pigtail), and can be detached from the BISx device for service or replacement
without the use of tools. The enclosure is sealed against liquid ingress even when the
PIC+ is detached.




The BISx4 connects to a sensor via the Aspect 4 channel Patient Interface Cable (here forth
referred to as CM PIC). The CM PIC is nominally 54 inches long. The CM PIC connection is
integral to the enclosure (no pigtail), and can be detached from the BISx4 device for
service or replacement without the use of tools. The enclosure is sealed against liquid
ingress even when the PIC+ is detached.




The BISx or BISx4 is attached to the host monitoring system via a nominal 9-foot monitor
cable. The host connector of the monitor cable is host system dependent and is the source
of future development with Datascope. The wire is narrow and highly flexible
multi-conductor cable used to supply power from the host monitor to the BISx/BISx4 as well
as allow communication between the devices. Additionally, the inability of the host
monitor to provide the BISx specified power requirements or communication requirements may
be addressed through the inclusion of a circuit which is integral to the monitor cable.




The monitor cable connection to the BISx/BISx4 device is integral to the enclosure (no
pigtail), and may require the use of tools for detachment from the BISx/BISx4 device
enclosure for the purposes of service or replacement. The enclosure is sealed against
liquid ingress only when the monitor cable is attached. There are no adjustable parts
inside the BISx. The cables may be replaced without opening the enclosure.




The BISx and BISx4 include software which is stored in reprogrammable FLASH memory.
Software upgrades can be accomplished via the serial / USB interface. Each BISx and BISx4
is given a unique serial identifier, allowing for electronic identification and tracking of
every BISx/BISx4.




PRELIMINARY TECHNICAL SPECIFICATIONS
(Unless otherwise noted specifications apply to both the BISx and BISx4)


Physical Specifications



BISx Kit

Size: 95.3 mm (3.75”) diameter x 63.5 mm (2.5”) height

Weight: approx 8.0 oz without cables

     approx 10.0 oz including PIC+



BISx Integral Cables

Host Monitor Cable: 2.74m (9ft)

Patient Interface Cable (PIC+): 1.4m (4.5 ft)




11/15









 







BISx4 Kit



Size: 95.3 mm (3.75”) diameter x 63.5 mm (2.5”) height

Weight: 227g (8.0 oz) without cables



BISx4 Integral Cables

Host Monitor Cable: 2.74m (9ft)

Patient Interface Cable (CM PIC): 1.4m (4.5 ft)



Safety Specifications





	 	•	 	The BISx and BISx4 comply with the essential requirements of the Medical Device
Directive 93/42/EEC, as well as IEC 60601-1 and IEC 60601-2-26.
	 
	 	•	 	They are both Type BF applied parts. Both the BISx and BISx4 have internal
optical coupling and an isolation transformer for patient isolation.
	 
	 	•	 	Both are protected against damage from defibrillation as long as the sensor is
not located between the defibrillator pads and is resistant to artifact from
electrosurgery.
	 
	 	•	 	United States federal law restricts these devices to sale by or on the order
of a physician.
	 
	 	•	 	BISx, BISx4, and cables are latex free.




Environmental Specifications



Liquid Ingress: IEC 529 IPX4

Temperature



0 to 40 degrees C operating

-40 to 70 degrees C storage

               Humidity



10% to 95% non-condensing operating

10% to 95% non-condensing storage



Pressure



480 to 1067 hPa operating (Approx -1250 to 20,000 feet)

116 to 1067 hPa storage (Approx -1250 to 50,000 feet)



Performance Specifications



Measurement Ranges

Bispectral Index (BIS): 0 to 100 unitless scale

Electromyographic Strength (EMG): 25 to 100 dB where 1 μV2=40dB

Signal Quality Index (SQI): 0 to 100%

Suppression Ratio (SR): 0 to 100%

Spectral Edge Frequency (SEF): 0.5 to 30.0 Hz

Total Power: 40 to 100 dB where 1 μV RMS=40dB

Burst Count: 0 to 30



Noise (EEG Waveform) < 0.3 μVRMS (2.0 μV peak-to-peak)

BIS Numeric Update Frequency Once per second

EEG Bandwidth 0.25 to 100 Hz (- 3dB)

Patient Leakage <10uA




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EXHIBIT C

CONTACT PERSONS/ADDRESSES




Contact Persons and Responsibilities at Aspect:




	 	 	 	 	 	 	 
	Person	 	Title	 	Responsibility	 	Email
	Joan Rubin

	 	Sr. Director,
	 	Contract
	 	jrubin@aspectms.com
	 

	 	Business	 	 	 	 
	 

	 	Development	 	 	 	 
	 
	 	 	 	 	 	 
	Steve Mesrobian

	 	Director, OEM
	 	Project Manager
	 	smesrobian@aspectms.com
	 

	 	Engineering	 	 	 	 
	 
	 	 	 	 	 	 
	Christine Vozella

	 	Senior Director,
	 	Quality and
	 	cvozella@aspectms.com
	 

	 	RA/QA
	 	Regulatory Matters	 	 
	 
	 	 	 	 	 	 
	James Charest

	 	OEM Engineer Manager
	 	Technical Design
	 	jcharest@aspectms.com
	 

	 	 	 	Issues	 	 






	 	       	 
	Mailing Address:

	 	Aspect Medical Systems, Inc.
	 

	 	One Upland Road
	 

	 	Norwood, MA 02062






Contact Persons and Responsibilities at Datascope:




	 	 	 	 	 	 	 
	Person	 	Title	 	Responsibility	 	Contact Information
	Richard Cipolli

	 	Engineering Manager
	 	Project Manager,
	 	E-mail:
	 

	 	 	 	Spectrum O.R.
	 	richard_cipolli@datascope.com
	 

	 	 	 	 	 	Tel: 1-201-995-8024
	 

	 	 	 	 	 	Fax: 1-201-995-8654
	 
	 	 	 	 	 	 
	Bonita Lisnay

	 	Purchasing
	 	Purchasing
	 	E-mail:
	 

	 	Supervisor
	 	 	 	bonita_lisnay@datascope.com
	 

	 	 	 	 	 	Tel: 1-201-995-8374
	 

	 	 	 	 	 	Fax: 1-201-995-8001
	 
	 	 	 	 	 	 
	Chuck Webster

	 	Director of
	 	Marketing
	 	E-mail:
	 

	 	Marketing & Sales
	 	 	 	chuck_webster@datascope.com
	 

	 	Solutions
	 	 	 	Tel: 1-201-995-8207
	 

	 	 	 	 	 	Fax: 1-201-995-8612
	 
	 	 	 	 	 	 
	Kathleen Kramer

	 	Supervisor,
	 	Regulatory
	 	E-mail:
	 

	 	Clinical and
	 	 	 	kathleen_kramer@datascope.com
	 

	 	Regulatory Affairs
	 	 	 	Tel: 1-201-995-8169

Fax: 1-201-995-8605






	 	 	 	 	 
	Address:
	 	Mindray DS USA, Inc.	 
	 
	 	800 MacArthur Blvd	 
	 
	 	Mahwah, NJ  07430	 






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EXHIBIT D

ASPECT AND DATASCOPE TRADEMARKS




	 	 	 
	Aspect Trademarks	 	Reference
	Aspect ®

	 	Aspect is a registered trademark of Aspect Medical Systems, Inc
	 
	 	 
	A-2000 TM

	 	A-2000 is a trademark of Aspect Medical
Systems, Inc.
	 
	 	 
	Bispectral Index ®

	 	Bispectral is a registered trademark of Aspect Medical Systems, Inc.
	 
	 	 
	BIS ®

	 	BIS is a registered trademark of Aspect Medical Systems, Inc.
	 
	 	 
	

	 	 BIS logo is a registered trademark of
Aspect Medical Systems, Inc.
	 
	 	 
	BISx TM

	 	BISx is a trademark of Aspect Medical Systems, Inc.
	 
	 	 
	BIS ReadyTM

	 	BIS Ready is a trademark of Aspect Medical Systems, Inc.
	 
	 	 
	BIS VISTA TM

	 	BIS VISTA is a trademark of Aspect Medical Systems, Inc.
	 
	 	 
	

	 	 BISx logo is a trademark of Aspect Medical Systems, Inc.
	 
	 	 
	

	 	 BIS Ready logo is a registered trademark of
Aspect Medical Systems, Inc.






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	Datascope Trademarks	 	Reference
	

	 	Datascope logo is a U.S. registered trademark of
Datascope Corp.
	 
	 	 
	Datascope®

	 	Datascope® is a U.S. registered trademark of
Datascope Corp.
	 
	 	 
	NavigatorTM

	 	NavigatorTM is a U.S. trademark of Datascope Corp.
	 
	 	 
	PanoramaTM

	 	PanoramaTM is a U.S. trademark of Datascope Corp.
	 
	 	 
	SpectrumTM

	 	SpectrumTM is a U.S. trademark of Datascope Corp.
	 
	 	 
	View 12TM

	 	View 12TM is a U.S. trademark of Datascope Corp.
	 
	 	 
	Passport 2®

	 	Passport 2® is a U.S. registered trademark of Datascope Corp.
	 
	 	 
	Auto-SetTM

	 	Auto-SetTM is a U.S. trademark of Datascope Corp.
	 
	 	 
	Rescale WavesTM

	 	Rescale WavesTM is a U.S. trademark of Datascope Corp.
	 
	 	 
	SmartScreenTM

	 	SmartScreenTM is a U.S. trademark of Datascope Corp.





Further Datascope Trademark information to be provided by Datascope within 30 days of signing
amendment.





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