Amendment 1 Attachment 2 - Cut Sheets (Salient Features_Specs).pdf

EmCyte Corporation

PL-42-24

REV 9.0

Operation Manual

Executive Series Centrifuge II

PN: GS-022624340

5702E

EXSBK-2B

EXSBK-2C

EXSBK-90

EXSBK-90C

Contents

Intended Use Page 2

Indications Page 2

General Safety Page 2

Installation Page 3

Operation Page 4

Maintenance Page 5

Technical Page 6

Warranty Page 7

Preventative Maintenance Log Page 8

Troubleshooting Guide Page 9

L1502

EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL 1

2 EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL

INTENDED USE

The Executive Series Centrifuge II and the Accelerate Executive Series Centrifuge are intended exclusively for indoor use and for separating autologous whole blood and bone marrow aspirate in the EmCyte Component Concentrating System.

The centrifuge may only be operated by trained staff. The operating manual should be read carefully, regardless of whether or not the individual(s) is familiar with the centrifuge.

INDICATIONS

The Executive Series Centrifuge II and the Accelerate Executive Series Centrifuge systems are used in conjunction with the EmCyte Component Concentrating System in the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood and/or bone marrow aspirate at the patient’s point of care. Autologous PRP, isolated through the use of the Executive Series Centrifuge II and the Accelerate Executive Series Centrifuge systems and the EmCyte Component Concentrating System, can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site or as deemed necessary by the clinical use requirements.

GENERAL SAFETY

To ensure that the centrifuge is operated in a safe manner, avoiding the hazard of injury to personnel or damage to material goods, the following safety precautions should be followed at all times:

• The centrifuge must only be opened by trained personnel competent in its use.

• Never use the centrifuge unless the rotor is properly mounted and secure.

• Never open, or attempt to open the lid while the centrifuge rotor is still turning.

• Only use original parts for the centrifuge.

• Never operate the centrifuge if components are missing or damaged.

• If the rotor becomes damaged it must be discontinued and replacement fitted.

• Only use EmCyte Concentrating Devices. Make sure that concentrating devices are balanced with equal volume and weight prior to centrifugation. Follow product IFU.

• No changes should be made to the mechanical or electrical components.

• The centrifuge has not been manufactured from inert materials or to be explosion proof.

• Ensure that it is not operated within an environment, or with materials that makes these a requirement.

• ONLY centrifuge whole blood or bone marrow aspirate in the Executive Series

Centrifuge II and the Accelerate Executive Series Centrifuge.

• Do not centrifuge corrosive, radioactive, flammable, or explosive substances. Do not centrifuge substances prone to react briskly with each other. Should any doubt exist regarding the suitability of a substance, consult safety personnel or call customer support to comply with national regulations (refer to World Health Organization: Laboratory Biosafety Manual).

• Concentrating device and/or Counter Balance MUST be loaded into the centrifuge OPPOSITE of each other and with each one containing the same volume. Failing to do so may result in damage to the centrifuge and/or personnel injury.

• In order to prevent damage to the compressor following improper transport, the device may not be switched on until four hours after setting up.

• Please remove the transport safety device and keep it for possible use if the device is subsequently moved again.

• Place the centrifuge on a solid, flat, non-resonant lab bench. The condensation water tray should be inserted from the side.

• The surrounding area must be well ventilated and protected against direct sunlight.

• To ensure that the ventilation of the device is not impaired, a fundamental clearance of 30 cm to the side and a minimum of 15 cm to the back wall must be maintained.

• During centrifugation, according to the recommendations set out in EN 61010-2-020 a safety clearance of 30 cm must be maintained around the centrifuge within which there are no objects which may be destroyed and so cause further damage.

• Only connect the device to power supplies which correspond with the electrical requirements on the name plate.

• Only use sockets with a protective earth (PE) conductor and suitable power cable.

DISPOSAL OF CENTRIFUGE

• Domestic

In the event that the centrifuge needs to be disposed of, contact the local state’s disposal agency and follow the state’s local disposal regulations of properly disposing an electronic medical equipment. PLEASE DO NOT DISPOSE THE CENTRIFUGE IN REGULAR TRASH.

• International In accordance with EU Directive 2002/96/EC on waste electrical and electronic equipment (WEEE), this product cannot be disposed of in municipal or domestic waste. They are marked with the following symbol to indicate this:

As disposal regulations within the EU may vary from country to country, please contact your supplier if necessary.

AEROSOL CAPS

• Aerosol caps are used to prevent biologic aerosol inside the centrifuge machine container.

Check the aerosol caps regularly for damage. Damaged aerosol caps must be replaced immediately. It is recommended that Aerosol Caps be used during the processing of blood components.

INSTALLATION

The instrument has been designed in such a way that installation should present no problems to a technician familiar with equipment of this type. Should any problems or questions arise during the installation of the instrument please call EmCyte Corporation’s customer support.

WORK SURFACE

The work surface must be stable and, where possible, resonance free. A standard laboratory bench is usually suitable. The location of the centrifuge should be well ventilated and out of direct sunlight, having sufficient room to allow air to circulate around it freely. A safety zone extending for 30cm in all directions must be maintained around the centrifuge. This space should be kept clear; in particular no hazardous material may be place in the area during centrifugation.

MAIN ELECTRICAL CONNECTION

Before connecting the unit to the main electrical connection, ensure that the voltage and frequency of supply match the specifications on the instrument.

ROTOR

The rotors and buckets must be loaded symmetrically. The adapters must be loaded only with the specified EmCyte Concentrating Devices. Symmetrical Concentrating Devices must have equal weight.

This will reduce wear on the drive and eliminate running noise. The centrifuges have an automatic imbalance detector, which shuts down the centrifuge if the weight differences are excessive. This is indicated by the error message in the display. Rotors are high-grade components which have to withstand extreme stresses and strains. Aluminum rotors are largely protected from corrosion by the most common laboratory chemicals by means of an anodized coating. This protection is not unlimited.

Protect the rotors from mechanical damage. Even minor scratches or cracks can result in serious internal material damage. Avoid damaging the rotors by the use of aggressive chemicals, such as:

strong and weak alkalis, strong acids, solutions of mercury, copper and other heavy metal ions, chlorinated hydrocarbons, concentrated salt solutions and phenol. If the rotor is contaminated by aggressive substances, clean it immediately with a mild cleaning agent.

EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL 3

4 EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL

SWING BUCKET ROTOR

The swing-bucket rotor is equipped with round or rectangular buckets. Make sure that the buckets are properly installed, lubricated lightly and can swing out freely. Carry out a manual swing test with empty Concentrating Devices. Avoid unbalanced loading of the Concentrating Devices. Before inserting the buckets in the grooves, make sure they are clean. Dirty grooves will prevent the buckets from swinging out evenly.

OPERATION

CENTRIFUGATION WITH TIMER SETTING

Switch on the centrifuge, with the mains power switch if necessary, and then with the switch. The nominal values of the last run are displayed. Load the rotor symmetrically and close down the centrifuge lid.

1. Time - Alters the running time.

2. Speed - Alters the speed in increments of 100 1/min or RCF.

3. Start - Starts the run. The symbol flashes while the rotor is running.

4. Stop - Stops the centrifuge. The symbol appears briefly as soon as the rotor comes to a standstill.

5. Stand-by - Centrifuge switched to stand-by mode.

6. Open - Releases the lid latch.

While the centrifuge is running the remaining time is displayed. The last minute is counted down in seconds. When the preset time elapses the centrifuge stops automatically and emits a signal tone to indicate the centrifugation is finished. The lid opens automatically following centrifugation. When you switch off the centrifuge at the main power switch the display goes blank after a few seconds' delay.

CENTRIFUGATION WITH “AT SET RPM” SETTING

For centrifugation, time can be counted either immediately from the start or not until attainment of the preset speed. Pressing the START / STOP button for longer than 2 seconds with the centrifuge lid open switches the "at set rpm" mode, symbolized by the pictogram .

To exit the "at set rpm" mode again and begin counting down the centrifugation time immediately after starting the centrifuge, press the START / STOP button again for longer than 2 seconds with the centrifuge lid open until the pictogram is displayed.

EMERGENCY LID RELEASE IN CASE OF LID LOCK FAILURE

In the unlikely event of the lid lock failing and the user being unable to remove their samples, an emergency lid release tool is provided.

WARNING: Operation of the emergency lid release must only be undertaken by qualified and approved personnel. Under no circumstances may the centrifuge be operated in the condition. Wait until the rotor has stopped turning (view through the lid port) and switch off the power to the centrifuge. Pull the release cord to open the lid.

WARNING: Under no circumstances must the emergency lid release be used while the centrifuge is running.

MAINTENANCE

CLEANING, DISINFECTING AND MAINTENANCE

It is also recommended that the rotor chamber be cleaned after each point of care use. The end user is responsible for appropriate cleaning and decontamination. Before cleaning, unplug the power plug with the lid open, unscrew the rotor using the rotor key supplied and clean it separately. Use a mild cleaning agent for cleaning the accessible surfaces of the device, for example, alcohol (ethanol, isopropanol) or alcohol-based disinfectants. Do not allow any liquid to get into the gap at the motor shaft outlet. For this reason, the rotor chamber should be cleaned only with a damp cloth. In order to ensure long-term, reliable work with your centrifuge, please note that aggressive chemicals may damage the rotor and the chamber. Check your device once a month for corrosion and damage. The rubber seals in the rotor chamber should be rinsed off thoroughly with water and lubricated with glycerin or talc after every clean to prevent them becoming brittle.

The rotors, buckets, tube holders and adapters should be cleaned after every use or when necessary with a neutral cleaning agent to prevent residues of the material being centrifuged from changing the properties of the centrifuge and its accessories. The rotor must be taken off for this. Never place components in disinfectants or cleaning agents which contain sodium hypochlorite/chlorine or are oxidants. This will cause the material to change. Disinfection with glutaraldehyde solution is possible.

We recommend Cidex activated glutaraldehyde solution. The plastic adapters and rubber plates are dishwasher safe. Check the tube holders and buckets for residues and corrosion. For thorough cleaning, clean all parts separately. Then refit the rotor and bolt it into place with the supplied rotor key.

WARNING: ISOLATE AND DISCONNECT THE POWER SUPPLY BEFORE CARRYING OUT CLEANING OR

MAINTENANCE.

CENTRIFUGE BODY

• Regularly wipe down the external surfaces with a mild detergent.

• Mop up any spillage with an absorbent cloth. Check to ensure that the liquid has not entered the main body of the centrifuge.

WARNING: If any liquid has entered the main body of the centrifuge it MUST NOT be used. Contact the supplier or EmCyte Corporation immediately for advice.

ROTOR

• Clean the rotor using a suitable detergent and hot water. Alternatively the rotor may be cleaned in an autoclave at a maximum temperature of 121 C° for 20 minutes.

• Thoroughly rinse and dry the rotor.

• Inspect the rotor for any hairline cracks, damage or other defects. If any are found please contact your supplier or EmCyte Corporation Inc.

EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL 5

6 EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL

TECHNICAL

TECHNICAL SPECIFICATIONS

Power output:

Max. Speed:

Max. Centrifugal acceleration:

Max. Load Max kinetic energy:

Permissible density of material being centrifuged:

Ambient temperature:

Maximum humidity:

Dimensions:

Weight excluding rotor:

Startup time (120 V, 230V):

Deceleration time (120 V, 230V):

Noise level:

200W

4400 RPM

3000 RCF

4 x 90mL 2 280 Nm 1, 2 g/ml 2 – 40 °C 75% Height: 241 mm Depth: 395 mm Width: 320 mm 20kg <25 sec <25 sec < 58 dB (A)

WARRANTY

The centrifuge machine comes with a one (1) year manufacturer warranty from the date of purchase by the first consumer purchaser of the product. The warranty only covers the cost of labor and replacement of mechanical or electrical parts that fail during normal operation. The manufacturer may use functionally equivalent reconditioned/refurbished/pre-owned or new products. Defects or damage that result from: (a) improper operation, storage, misuse or abuse, accident or neglect, such as physical damage (cracks, scratches, etc.) to the surface of the product resulting from misuse; (b) contact with liquid, water, rain, extreme humidity or heavy perspiration, sand, dirt or the like, extreme heat, or food; (c) use of the products or accessories for commercial purposes or subjecting the product or accessory to abnormal usage or conditions; or (d) other acts which are not the fault of the manufacturer, are excluded from coverage. Defects or damages resulting from service, testing, adjustment, installation, maintenance, alteration, including without limitation, software changes, or modification in any way by someone other than the manufacturer, or its authorized service centers, are excluded from coverage. The service is done at the manufacturer’s repair facility, not on site. The customer pays for shipping and handling.

PREVENTATIVE MAINTENANCE & CARE

The preventative maintenance & care is done on site by the operator. A preventative maintenance log must be kept at the facility of operation. Provided with the machine is a preventative maintenance & care instruction sheet. Each item must be performed and recorded. Preventative maintenance services are done according to facility schedule.

LIMITATIONS

Any implied warranties, including without limitation the implied warranties of merchantability and fitness for a particular purpose, shall be limited to the duration of this limited warranty, otherwise the repair or replacement, as provided under this express limited warranty is the exclusive remedy of the consumer, and is provided in lieu of all other warranties, express or implied. In no event shall the manufacturer be liable, whether in contract or tort (including negligence) for damages in excess of the purchase price of the product, accessory or software, or for any indirect, incidental, special or consequential damages of any kind, or loss of revenue or profits, loss of business, loss of information or data, software or applications or other financial loss arising out of or in connection with the ability or inability to use the products, accessories or software to the full extent these damages may be disclaimed by law.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. The physician is solely responsible for the use of this device

This system contains: 1 Executive Series Centrifuge, 1 Centrifuge rotor, 4 hanging buckets with caps.

NON

STERILE

Authorized Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel: (31) (0) 70 345-8570 Fax: (31) (0) 70 346-7299

EmCyte Corporation, Inc.

13881 Plantation Road, Suite 2 Fort Myers, FL 33912, USA Phone: 239-481-7725

Australian Sponsor Emergo Australia Level 20 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia Tel: +61(0) 2 9006 1662 Fax: + 61 (0) 2 9006 1010

EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL 7

CORPORATE QUOTATION

QUOTE DATE:* 1/9/2019

QUOTE NUMBER L5144155

SHIP TO (BILL TO MAY BE DIFFERENT):

EGLIN AFB

307 BOATNER RD.

EGLIN AFB, FL 32542

UNITED STATES

TERMS: NET 15

QUOTE TOTAL:

AN EMERGING SMALL BUSINESS CONCERN

CAGE CODE: 60B94 (second character is a "zero")

SUGGESTED NAICS: 334510

REGISTERED IN: SAM

DUNS: 962568338

EIN: 27-2578777

*THIS QUOTE IS VALID FOR A PERIOD OF 30 DAYS, OR UNTIL THE PRICE CHANGES, WHICH

MAY OR MAY NOT BE WITHOUT NOTIFICATION, WHICHEVER OCCURS FIRST.

PROVEN RESULTS. SIMPLIFIED.

ECAT CONTRACT#:

SPE2DH-17-D-0025

EXPIRES: 08/31/2022

PROAIM Americas, LLC.

P.O. Box 724 Grover, MO. 63040 Ph.: (844) 467-7624

PROAIM MEDICAL MAKES NO WARRANTY, IMPLIED OR OTHERWISE, FOR THE ITEM(S) ON THIS QUOTATION. THE ONLY APPLICABLE TERMS AND CONDITIONS REGARDING THE ITEM(S) ARE THOSE AS SET BY THE VENDOR PROAIM MEDICAL PURCHASED THE ITEM(S) FROM AND/OR THE MANUFACTURER. IF A COPY OF THESE TERMS AND CONDITIONS IS NEEDED, PLEASE REQUEST A COPY PRIOR TO PLACING AN ORDER AS THE APPLICABLE TERMS AND CONDITIONS WILL BE ENFORCED FROM THE TIME THE ITEM(S) IS ORDERED.

Suggested NAICS: 334510

PROAIM: (844) 467.7624

DLA 'ECAT CONTRACT:' SPE2DH-17-D-0025

quotes@proaim-medical.com https://www.medical.dla.mil/registration/sitelogin.aspx?CTAuthMode=BASIC&language=en Government Customers can place ECAT Orders here:

INDIVIDUAL ECAT ORDERS OVER $250K WILL REQUIRE AN ("LSJ")

Government Customers requiring additional ECAT ordering assistance can contact:

ECAT HelpDesk at (800) 290-8201 or DSCPECATHELP@dla.mil

PROAIM ECAT SUPPLIER ID#: 900100705

ITEM CODE DESCRIPTION ECAT CONTRACT # QTYITEM PRICE LINE TOTAL

266002-1149-100 ZEISS OS | CIRRUS HD-OCT (MODEL 5000)

VERSION 9.0 (INCLUDES SMART HD SCANS,

FASTTRAC, ALL PRIOR LICENSED

FEATURES, ADVANCED RPE, GCA,

ANTERIOR SEGMENT BASIC, PRINTER &

TABLE | EA

** #266002-1157-764 - ANTERIOR SEGMENT

PREMIER MODULE INCLUDED WITH THE

PURCHASE OF THIS CIRRUS UNIT AT NO

ADDITIONAL COST**

**TECHNICAL SPECIFICATIONS**

Has the capability to capture and provide OCT Angiography: This capability for OCT Angiography is provided by a 1 single OCT scan that allows for visualization of both micro vascular and structural information in an noninvasive dye free scan by the

OCT.

Has the ability to import and integrate the Cirrus Model HD OCT 4000 raw data. The raw data must be interchangeable between the Cirrus 4000 and Cirrus 5000 unit (or new unit being procured).

The unit must have exact Macular Scan Pattern of 512x128 for retina scan with exact scanning speed at 27,000 A-scans a second within a 6mmx6mm.

Must be able to provide on Company Literature

The unit must have exact scan pattern of 200x200 in a 6mmx6mm cube for Glaucoma Scan with exact scanning speed at 27,000 A-scans a second. The scan pattern must be able to capture and provide RNFL, ONH, Neuro Retinal Rim Tissue, and 3-D Cube capabilities all in one scan

Scanning speeds: Scan at exactly 27,000 A-scans/sec, as well as the ability to scan at 68,000 A-scans/sec

SPE2DH-17-D-0025

M5510 / U5021 / M5551 / U6023

QUOTE NUMBER L5144155

SHIP TO (BILL TO MAY BE DIFFERENT):

EGLIN AFB

307 BOATNER RD.

EGLIN AFB, FL 32542

UNITED STATES

TERMS: NET 15

QUOTE TOTAL:

AN EMERGING SMALL BUSINESS CONCERN

CAGE CODE: 60B94 (second character is a "zero")

SUGGESTED NAICS: 334510

REGISTERED IN: SAM

DUNS: 962568338

EIN: 27-2578777

*THIS QUOTE IS VALID FOR A PERIOD OF 30 DAYS, OR UNTIL THE PRICE CHANGES, WHICH

MAY OR MAY NOT BE WITHOUT NOTIFICATION, WHICHEVER OCCURS FIRST.

PROVEN RESULTS. SIMPLIFIED.

ECAT CONTRACT#:

SPE2DH-17-D-0025

EXPIRES: 08/31/2022

PROAIM Americas, LLC.

P.O. Box 724 Grover, MO. 63040 Ph.: (844) 467-7624

PROAIM MEDICAL MAKES NO WARRANTY, IMPLIED OR OTHERWISE, FOR THE ITEM(S) ON THIS QUOTATION. THE ONLY APPLICABLE TERMS AND CONDITIONS REGARDING THE ITEM(S) ARE THOSE AS SET BY THE VENDOR PROAIM MEDICAL PURCHASED THE ITEM(S) FROM AND/OR THE MANUFACTURER. IF A COPY OF THESE TERMS AND CONDITIONS IS NEEDED, PLEASE REQUEST A COPY PRIOR TO PLACING AN ORDER AS THE APPLICABLE TERMS AND CONDITIONS WILL BE ENFORCED FROM THE TIME THE ITEM(S) IS ORDERED.

Suggested NAICS: 334510

PROAIM: (844) 467.7624

DLA 'ECAT CONTRACT:' SPE2DH-17-D-0025

quotes@proaim-medical.com https://www.medical.dla.mil/registration/sitelogin.aspx?CTAuthMode=BASIC&language=en Government Customers can place ECAT Orders here:

INDIVIDUAL ECAT ORDERS OVER $250K WILL REQUIRE AN ("LSJ")

Government Customers requiring additional ECAT ordering assistance can contact:

ECAT HelpDesk at (800) 290-8201 or DSCPECATHELP@dla.mil

PROAIM ECAT SUPPLIER ID#: 900100705

ITEM CODE DESCRIPTION ECAT CONTRACT # QTYITEM PRICE LINE TOTAL

Unit must be able to provide a report for Ganglion Cell Analysis that is derived from a scan must be comprised of 6mmx6mm cube scan with a minimum by 200x200 line scan pattern with no more than 30 microns between each slice.

Minimum Pupil Requirements must be 2.0mm or less.

Unit must utilize an LSO Fundus Camera (Line Scanning Laser Ophthalmoscope). .

The unit must Automatically Track to Prior Scan:

The unit must be able to do this without technician needing to align to prior scan:

Anterior Segment scan that is at minimal 15.5 mm in length x 5.8 mm in depth. which is the full view of the Anterior Chamber. Must be able to provide on Company Literature.

Global Pachymetry report that is comprised of minimum of 24 radial scans and must be at a minimum 9mm in length.

The unit must be a 90 degree configuration, so that the tech (operator) must sit to the side (90 degrees) of the pa

OCT Imaging:

Methodology - Spectral domain OCT Optical source - Superluminescent diode (SLD), 840 nm Scan speed - 27,000 A-scans per second or 68,000 A-scans per second* *All existing scan patterns in version 6.5 software will run at 27,000 A-scans per second, which is the same scan speed as the

CIRRUS 4000.

**All patient data from the Cirrus 4000 instrument

QUOTE NUMBER L5144155

SHIP TO (BILL TO MAY BE DIFFERENT):

EGLIN AFB

307 BOATNER RD.

EGLIN AFB, FL 32542

UNITED STATES

TERMS: NET 15

QUOTE TOTAL:

AN EMERGING SMALL BUSINESS CONCERN

CAGE CODE: 60B94 (second character is a "zero")

SUGGESTED NAICS: 334510

REGISTERED IN: SAM

DUNS: 962568338

EIN: 27-2578777

*THIS QUOTE IS VALID FOR A PERIOD OF 30 DAYS, OR UNTIL THE PRICE CHANGES, WHICH

MAY OR MAY NOT BE WITHOUT NOTIFICATION, WHICHEVER OCCURS FIRST.

PROVEN RESULTS. SIMPLIFIED.

ECAT CONTRACT#:

SPE2DH-17-D-0025

EXPIRES: 08/31/2022

PROAIM Americas, LLC.

P.O. Box 724 Grover, MO. 63040 Ph.: (844) 467-7624

PROAIM MEDICAL MAKES NO WARRANTY, IMPLIED OR OTHERWISE, FOR THE ITEM(S) ON THIS QUOTATION. THE ONLY APPLICABLE TERMS AND CONDITIONS REGARDING THE ITEM(S) ARE THOSE AS SET BY THE VENDOR PROAIM MEDICAL PURCHASED THE ITEM(S) FROM AND/OR THE MANUFACTURER. IF A COPY OF THESE TERMS AND CONDITIONS IS NEEDED, PLEASE REQUEST A COPY PRIOR TO PLACING AN ORDER AS THE APPLICABLE TERMS AND CONDITIONS WILL BE ENFORCED FROM THE TIME THE ITEM(S) IS ORDERED.

Suggested NAICS: 334510

PROAIM: (844) 467.7624

DLA 'ECAT CONTRACT:' SPE2DH-17-D-0025

quotes@proaim-medical.com https://www.medical.dla.mil/registration/sitelogin.aspx?CTAuthMode=BASIC&language=en Government Customers can place ECAT Orders here:

INDIVIDUAL ECAT ORDERS OVER $250K WILL REQUIRE AN ("LSJ")

Government Customers requiring additional ECAT ordering assistance can contact:

ECAT HelpDesk at (800) 290-8201 or DSCPECATHELP@dla.mil

PROAIM ECAT SUPPLIER ID#: 900100705

ITEM CODE DESCRIPTION ECAT CONTRACT # QTYITEM PRICE LINE TOTAL

can be transferred into the Cirrus 5000 seamlessly and used immediately for Guided Progression Analysis or any other Cirrus analytical program** A-scan depth - 2.0mm (in tissue), 1024 points Axial resolution - 5 um (in tissue) Transverse resolution - 15 um (in tissue) Cube scan pattern - 512 x 126 with over >67 million data ports and 47um spacing between lines Cube scan pattern - 200 x 200 with over >40 million data ports and 30um spacing between lines

Fundus Imaging:

Methodology - Line scanning ophthalmoscope

(LSO)

Live fundus image - during alignment and during OCT scan Optical source - Superluminescent diode (SLD), 750nm Field of view - 36 degrees Wx 30 degrees H Frame rate - >20 Hz Transverse resolution - 25 um (in tissue)

Iris Imaging:

Methodology - CCD Camera Resolution - 1280 x 1024 Live iris image - During alignment Electrical and Physical:

Weight - 80 lbs.

Dimensions of instrument - 26L x 18Wx 21H (in) Dimensions of table - 39L X 22W(in)

Fixation:

Internal fixation focus adjustment - -20D to +20D (diopters) Electrical rating (115V) - Single Phase, 100-120V~systems: 50/60Hz, 5A Electrical rating (230V) - Single Phase, 200-240V~systems: 50/60Hz, 2.5A

QUOTE NUMBER L5144155

SHIP TO (BILL TO MAY BE DIFFERENT):

EGLIN AFB

307 BOATNER RD.

EGLIN AFB, FL 32542

UNITED STATES

TERMS: NET 15

QUOTE TOTAL:

AN EMERGING SMALL BUSINESS CONCERN

CAGE CODE: 60B94 (second character is a "zero")

SUGGESTED NAICS: 334510

REGISTERED IN: SAM

DUNS: 962568338

EIN: 27-2578777

*THIS QUOTE IS VALID FOR A PERIOD OF 30 DAYS, OR UNTIL THE PRICE CHANGES, WHICH

MAY OR MAY NOT BE WITHOUT NOTIFICATION, WHICHEVER OCCURS FIRST.

PROVEN RESULTS. SIMPLIFIED.

ECAT CONTRACT#:

SPE2DH-17-D-0025

EXPIRES: 08/31/2022

PROAIM Americas, LLC.

P.O. Box 724 Grover, MO. 63040 Ph.: (844) 467-7624

PROAIM MEDICAL MAKES NO WARRANTY, IMPLIED OR OTHERWISE, FOR THE ITEM(S) ON THIS QUOTATION. THE ONLY APPLICABLE TERMS AND CONDITIONS REGARDING THE ITEM(S) ARE THOSE AS SET BY THE VENDOR PROAIM MEDICAL PURCHASED THE ITEM(S) FROM AND/OR THE MANUFACTURER. IF A COPY OF THESE TERMS AND CONDITIONS IS NEEDED, PLEASE REQUEST A COPY PRIOR TO PLACING AN ORDER AS THE APPLICABLE TERMS AND CONDITIONS WILL BE ENFORCED FROM THE TIME THE ITEM(S) IS ORDERED.

Suggested NAICS: 334510

PROAIM: (844) 467.7624

DLA 'ECAT CONTRACT:' SPE2DH-17-D-0025

quotes@proaim-medical.com https://www.medical.dla.mil/registration/sitelogin.aspx?CTAuthMode=BASIC&language=en Government Customers can place ECAT Orders here:

INDIVIDUAL ECAT ORDERS OVER $250K WILL REQUIRE AN ("LSJ")

Government Customers requiring additional ECAT ordering assistance can contact:

ECAT HelpDesk at (800) 290-8201 or DSCPECATHELP@dla.mil

PROAIM ECAT SUPPLIER ID#: 900100705

ITEM CODE DESCRIPTION ECAT CONTRACT # QTYITEM PRICE LINE TOTAL

Internal Computer:

Operating system/processor - Windows 7, i& Intel processor Memory: Hard drive/internal storage - >=750 GB, > 80,000 scans Display - Integrated 19" color flat panel display, USB ports - 6 ports

266002-1160-794 ***ITEM DOES NOT INCLUDE TABLE.***

ZEISS OS | VISUCAM 224 W/PRINTER | 1/EA

SPE2DH-17-D-0025

266002-1160-696 ZEISS OS | TABLE POWER MODEL1 18 X 36

K2-110C | EA

SPE2DH-17-D-0025

266002-1157-206 ZEISS OS | HFA3 MODEL 860 W/ LIQUID

TRIAL LENS, RELEYE, KINETIC, GPA, HEAD

TRK, GAZE TRK, PRINTER & TABLE | 1/EA

****TECHNICAL SPECIFICATIONS****

Dimension: 46 L x 52 W x 58 H (cm) which is exactly equivalent to: 18.11 L x 20.47 W x 22.83 H (inch)

Electrical Requirement: 100-120v- 50/60 Hz, 4.0A

Internal Storage: 500 Gb

Operating System: Windows 7-64 bit

Fixation Control

• Video eye monitor

• Heijl-Krakau blind spot monitor

• Gaze Tracking

• Head Tracking

• Vertex Monitoring

Visual Field Index™: Summary measurement of the patient’s visual field status, expressed as a percent of a normal age-adjusted visual field.

SPE2DH-17-D-0025 1

QUOTE NUMBER L5144155

SHIP TO (BILL TO MAY BE DIFFERENT):

EGLIN AFB

307 BOATNER RD.

EGLIN AFB, FL 32542

UNITED STATES

TERMS: NET 15

QUOTE TOTAL:

AN EMERGING SMALL BUSINESS CONCERN

CAGE CODE: 60B94 (second character is a "zero")

SUGGESTED NAICS: 334510

REGISTERED IN: SAM

DUNS: 962568338

EIN: 27-2578777

*THIS QUOTE IS VALID FOR A PERIOD OF 30 DAYS, OR UNTIL THE PRICE CHANGES, WHICH

MAY OR MAY NOT BE WITHOUT NOTIFICATION, WHICHEVER OCCURS FIRST.

PROVEN RESULTS. SIMPLIFIED.

ECAT CONTRACT#:

SPE2DH-17-D-0025

EXPIRES: 08/31/2022

PROAIM Americas, LLC.

P.O. Box 724 Grover, MO. 63040 Ph.: (844) 467-7624

PROAIM MEDICAL MAKES NO WARRANTY, IMPLIED OR OTHERWISE, FOR THE ITEM(S) ON THIS QUOTATION. THE ONLY APPLICABLE TERMS AND CONDITIONS REGARDING THE ITEM(S) ARE THOSE AS SET BY THE VENDOR PROAIM MEDICAL PURCHASED THE ITEM(S) FROM AND/OR THE MANUFACTURER. IF A COPY OF THESE TERMS AND CONDITIONS IS NEEDED, PLEASE REQUEST A COPY PRIOR TO PLACING AN ORDER AS THE APPLICABLE TERMS AND CONDITIONS WILL BE ENFORCED FROM THE TIME THE ITEM(S) IS ORDERED.

Suggested NAICS: 334510

PROAIM: (844) 467.7624

DLA 'ECAT CONTRACT:' SPE2DH-17-D-0025

quotes@proaim-medical.com https://www.medical.dla.mil/registration/sitelogin.aspx?CTAuthMode=BASIC&language=en Government Customers can place ECAT Orders here:

INDIVIDUAL ECAT ORDERS OVER $250K WILL REQUIRE AN ("LSJ")

Government Customers requiring additional ECAT ordering assistance can contact:

ECAT HelpDesk at (800) 290-8201 or DSCPECATHELP@dla.mil

PROAIM ECAT SUPPLIER ID#: 900100705

ITEM CODE DESCRIPTION ECAT CONTRACT # QTYITEM PRICE LINE TOTAL

Liquid Trial Lens™: Using Liquid pressure, delivers each patient’s refractive correction. Available correction range is -8 to +8 diopters. Spherical correction only. Liquid Trial Lens available in model 860 only.

SmartTouch interface: Touch screen interface allows for a more efficient workflow

RelEye: The RelEYE fixation monitoring system allows for systematic and pin point fixation inspection. The HFA 3 captures and keeps the image of the eye during the testing and just after, prior to the Result Review Screen. RelEYE cannot be viewed on the HFA 3 after terminating the test.

Using the HFA 3, RelEYE is also available in FORUM Glaucoma Workplace (minimum version 2.0.3). Only FORUM can keep the RelEYE data stored for future usage for exporting exams.

Guided Progression Analysis (GPA™): GPA allows the doctor to compare visual field status and progression to data collected from glaucoma subjects. GPA provides statistically significant change as well as rate of change, and predict future vision quality.

Connectivity: For comprehensive connectivity the HFA 3 can be connected to FORUM (minimum version 3.2) with FORUM Glaucoma Workplace (minimum version 2.0.3). DICOM conformant as per the DICOM Conformant Statement, available at http://www.zeiss.com/meditec/en_us/products---sol utions/ophthalmology-optometry/dicom.html HFA 3 also supports common file folder sharing used by most Electronic Medical Record Systems

(EMR).

SITATM (Swedish Interactive Threshold Algorithm): A patented algorithm for fast and accurate visual field threshold measurements; it is the most commonly used test strategy and

QUOTE NUMBER L5144155

SHIP TO (BILL TO MAY BE DIFFERENT):

EGLIN AFB

307 BOATNER RD.

EGLIN AFB, FL 32542

UNITED STATES

TERMS: NET 15

QUOTE TOTAL:

AN EMERGING SMALL BUSINESS CONCERN

CAGE CODE: 60B94 (second character is a "zero")

SUGGESTED NAICS: 334510

REGISTERED IN: SAM

DUNS: 962568338

EIN: 27-2578777

*THIS QUOTE IS VALID FOR A PERIOD OF 30 DAYS, OR UNTIL THE PRICE CHANGES, WHICH

MAY OR MAY NOT BE WITHOUT NOTIFICATION, WHICHEVER OCCURS FIRST.

PROVEN RESULTS. SIMPLIFIED.

ECAT CONTRACT#:

SPE2DH-17-D-0025

EXPIRES: 08/31/2022

PROAIM Americas, LLC.

P.O. Box 724 Grover, MO. 63040 Ph.: (844) 467-7624

PROAIM MEDICAL MAKES NO WARRANTY, IMPLIED OR OTHERWISE, FOR THE ITEM(S) ON THIS QUOTATION. THE ONLY APPLICABLE TERMS AND CONDITIONS REGARDING THE ITEM(S) ARE THOSE AS SET BY THE VENDOR PROAIM MEDICAL PURCHASED THE ITEM(S) FROM AND/OR THE MANUFACTURER. IF A COPY OF THESE TERMS AND CONDITIONS IS NEEDED, PLEASE REQUEST A COPY PRIOR TO PLACING AN ORDER AS THE APPLICABLE TERMS AND CONDITIONS WILL BE ENFORCED FROM THE TIME THE ITEM(S) IS ORDERED.

Suggested NAICS: 334510

PROAIM: (844) 467.7624

DLA 'ECAT CONTRACT:' SPE2DH-17-D-0025

quotes@proaim-medical.com https://www.medical.dla.mil/registration/sitelogin.aspx?CTAuthMode=BASIC&language=en Government Customers can place ECAT Orders here:

INDIVIDUAL ECAT ORDERS OVER $250K WILL REQUIRE AN ("LSJ")

Government Customers requiring additional ECAT ordering assistance can contact:

ECAT HelpDesk at (800) 290-8201 or DSCPECATHELP@dla.mil

PROAIM ECAT SUPPLIER ID#: 900100705

ITEM CODE DESCRIPTION ECAT CONTRACT # QTYITEM PRICE LINE TOTAL

incorporates patient responses in real time.

SITA database: The SITA normative database contains normative data for SITA Standard and SITA Fast 30-2, 24-2 and 10-2 threshold visual field test results from healthy subjects aged 17 to 89.

SITA-SWAP™ / Blue-Yellow Perimetry: Replaces the Full Threshold and FastPac strategies for testing SWAP visual fields due to the much shorter test times available when utilizing SITA SWAP

STATPAC™: It is a software package using normative values and patient data to perform statistically analysis to help interpret test data.

STATPAC is the software, normative data and statistical analysis in HFA.

Kinetic Testing: In kinetic testing, light stimulus of fixed characteristics is moved into the visual field from a non-seeing area, until it is detected by the patient. Typically, the stimulus is brought toward the center from several directions and the operator marks the location at which the patient first detects the stimulus (threshold point). The HFA 3 provides a kinetic graphical interface with full 180º testing range.

Glaucoma Hemifield Test (GHT): Compares points in the superior and inferior hemifield to provide analysis of test results. On 24-2 and 30-2 tests, the GHT evaluates five zones in the superior field and compares these zones to their mirrored zones in the inferior field. The GHT evaluates the severity of disturbed points in each zone pair, relative to its normal database.

Legacy data: patient legacy data can be transferred from the HFA II and HFA II-i to the HFA 3.

FORUM Glaucoma Workplace (minimum version 2.0.3): Allows to review quantitative and qualitative information from all standard HFA analyses; change baseline and capture, track and measure progression

QUOTE NUMBER L5144155

SHIP TO (BILL TO MAY BE DIFFERENT):

EGLIN AFB

307 BOATNER RD.

EGLIN AFB, FL 32542

UNITED STATES

TERMS: NET 15

QUOTE TOTAL:

AN EMERGING SMALL BUSINESS CONCERN

CAGE CODE: 60B94 (second character is a "zero")

SUGGESTED NAICS: 334510

REGISTERED IN: SAM

DUNS: 962568338

EIN: 27-2578777

*THIS QUOTE IS VALID FOR A PERIOD OF 30 DAYS, OR UNTIL THE PRICE CHANGES, WHICH

MAY OR MAY NOT BE WITHOUT NOTIFICATION, WHICHEVER OCCURS FIRST.

PROVEN RESULTS. SIMPLIFIED.

ECAT CONTRACT#:

SPE2DH-17-D-0025

EXPIRES: 08/31/2022

PROAIM Americas, LLC.

P.O. Box 724 Grover, MO. 63040 Ph.: (844) 467-7624

PROAIM MEDICAL MAKES NO WARRANTY, IMPLIED OR OTHERWISE, FOR THE ITEM(S) ON THIS QUOTATION. THE ONLY APPLICABLE TERMS AND CONDITIONS REGARDING THE ITEM(S) ARE THOSE AS SET BY THE VENDOR PROAIM MEDICAL PURCHASED THE ITEM(S) FROM AND/OR THE MANUFACTURER. IF A COPY OF THESE TERMS AND CONDITIONS IS NEEDED, PLEASE REQUEST A COPY PRIOR TO PLACING AN ORDER AS THE APPLICABLE TERMS AND CONDITIONS WILL BE ENFORCED FROM THE TIME THE ITEM(S) IS ORDERED.

Suggested NAICS: 334510

PROAIM: (844) 467.7624

DLA 'ECAT CONTRACT:' SPE2DH-17-D-0025

quotes@proaim-medical.com https://www.medical.dla.mil/registration/sitelogin.aspx?CTAuthMode=BASIC&language=en Government Customers can place ECAT Orders here:

INDIVIDUAL ECAT ORDERS OVER $250K WILL REQUIRE AN ("LSJ")

Government Customers requiring additional ECAT ordering assistance can contact:

ECAT HelpDesk at (800) 290-8201 or DSCPECATHELP@dla.mil

PROAIM ECAT SUPPLIER ID#: 900100705

ITEM CODE DESCRIPTION ECAT CONTRACT # QTYITEM PRICE LINE TOTAL

with G

PRICE INCLUDES:

•ONE YEAR MANUFACTURER WARRANTY

•DELIVERY

•INSTALLATION OF STAND-ALONE

INSTRUMENT ONLY (CUSTOMER IS SOLELY

RESPONSIBLE FOR INTEGRATION AND

CONNECTIVITY TO NETWORK, IF

APPLICABLE AND DESIRED).

MANUFACTURER CAN PROVIDE TECHNICAL

SUPPORT VIA REMOTE TELEPHONE

CONVERSATION AS IT RELATES TO

APPROPRIATE NETWORK PORTS AND

SETTINGS.

•TRAINING

•TWO OPERATORS MANUALS

•TWO SERVICE MANUALS

Perry Dynamics, Inc. 2810 North Jasper Street Decatur, Illinois USA www.PerryDynamics.com T 217.872.1530 F 217.872.1010

The Innova Group Quotation # 181217-1 Eglin AFB, FL 17 December 2018

PROPRIO® 5000 Quotation

Qty. Item Unit Price (US$) 1 ea. PROPRIO® 5000 System

Machine

- 36” Diameter User Platform

- 36” High Handrails

- Machine Dimensions: 70” Deep x 48” Wide x 95”-107” Tall

- Machine Weight: 700 lbs.

- Power Requirements: 208VAC, Single Phase, 30 Amp

- User’s Weight Capacity: 500 lbs. (Center) 350 lbs. (Outer Perimeter)

- Variable Speed Settings: 1-10

- Maximum Tilt: 18° Predictable Mode 25° Random, Burst, Lateral, & Ant./Post.

Computer

- Dell Optiplex SFF Computer

- 22” Touch Screen Monitor

- Power Requirements: Standard 110VAC

- Computer Cart (24” Deep x 24” Wide x 60” Tall) Software

- PROPRIOSoft 5000 Version 1.08

- Comprehensive User Database

- Programmable Protocol Page Testing Equipment

- Motion Capture Camera System

- Measures Ant./Post., Lateral L/R, & Up/Down Movements, Lateral Flexion, Flexion/Extension, Rotation

- Pre-programmed Standardized PROPRIO® Test

- Pre-programmed Postural Control Test

- Testing & Training Capabilities with Objective Feedback

- DMA (Dynamic Motion Analysis™) Graphs- Biofeedback Capabilities

- 44” & 50” DMA Belts Overhead Harness

- Full Body Harness Warranty

- Standard One Year Warranty (See Attached)

1 ea.

1 ea. Shipping & Handling, Installation and In-service

TERMS: Net 30 Days SHIPPING & HANDLING: F.O.B. Destination

PRICES ARE VALID FOR 30 DAYS FROM DATE OF QUOTATION

U4021

Perry Dynamics, Inc. 2810 North Jasper Street Decatur, Illinois USA www.PerryDynamics.com T 217.872.1530 F 217.872.1010

PROPRIO® Reactive Balance Systems

Standard Warranty Information Perry Dynamics, Inc. warrants that the PROPRIO® Systems will be free from defects in material and workmanship under normal use and service for the following periods and in the following respects:

30 day warranty on manufacturer’s defects on upholstery, rubber mats, rubber lip material and bellows

1 year warranty on all non-structural parts and labor, including platform drive mechanism and all electrical components not otherwise disclosed in this warranty. Warranty also included on computer, monitor, safety harness and motion capture testing equipment.

5 year warranty on all non-moving structural parts

Optional Extended Warranty Optional Extended Warranty on all non-structural parts and labor including platform drive mechanism and all electrical components not otherwise disclosed in this warranty. Extended warranty also covers computer, monitor and motion capture testing equipment. Upholstery, rubber mats, rubber lip material, bellows, and safety harness are not covered under the extended warranty.

Warranty coverage may be extended by one, two or three years beyond the one year Standard Warranty. If the extended warranty is purchased after 30 days of the original purchase date of the machine, and while the machine is still covered by a Standard Warranty or an Extended Warranty, the cost to purchase the extended warranty increases by $500 per year*.

If your warranty has expired, contact Perry Dynamics, Inc. for warranty purchase information. Costs start at $2,500 per year, but are based on age and condition of the machine.

The Fine Print:

- This warranty does not cover damage or equipment failure due to misuse or failure to comply with electrical requirements. Relocation, modification or misuses by the buyer, its agents and/or employees will, at the option of Perry Dynamics Inc. (PDI) void all product warranties.

- Claims under this warranty must be presented to PDI in writing and be received by PDI prior to the expiration of the warranty period.

- PDI’s sole obligation and the buyer’s sole remedy under this warranty shall be repair or replacement of the defective product at the discretion of PDI.

- PDI shall in no way be responsible for the suitability of the PROPRIO® Systems for any particular use. Final determination of the suitability of the products for the use contemplated by the buyer, its agents and/or employees is the responsibility of the buyer, its agents and/or employees.

- PDI will in no way be held liable for incidental or consequential damages, losses or expenses in connection with, or by reason of the inability to use the products for any purpose.

- PDI will in no way be liable for damages and/or injuries incurred by the buyer, its agents and employees, by virtue of defects in the products, even if PDI has been advised of the possibility of such damages.

- To the maximum extent permitted by applicable law, PDI disclaims all other warranties or conditions, express, implied, or statutory, relating to the product.

All prices and descriptions are subject to change without notice.

v.16.06.01

U4021 v 1.1 MagVenture Inc. - 2300 Lakeview Parkway, Suite 700 - Alpharetta, Georgia 30009 - USA

Phone: 888.624.7764 - Fax: 678.809.1415 - infousa@magventure.com - www.magventure.com Initials _____

SALES QUOTATION

Customer Purchase Agreement

2-Jan-19

QUOTE # MJT3182 Gail Cisneros Quote Validity: 30 Days Senior Equipment Planner

NICoE Satellite Elgin AFB, 96 AMDS/TWC , 307 Boatner Rd.

Elgin AFB,Fl 32542 P:(210) 867 2566 gail.cisneros@theinnovagroup.com

Part No. Unit Price Qty

Extended Price with 20% discount pre-applied

9016E0721 · MagPro® R30 Magnetic Stimulator, 230V 1 $

9016D0031 · Isolation Transformer rTMS System 1

9016E0482 · C-B60 Butterfly Coil with power control 1

9016B0191 · Marking Accessories for DLPFC positioning 1

9016E0491 · Cool B65 dynamic cooled butterfly coil 1

9016B0151 · Coil Cooler for Cool Coils 1

9016B0383 · Trolley for MagPro® (including coil holder accessories 9016B0281) 1 $

9016B0181 · Super Flex Arm for Coil Positioning (short) $ 1 $

9016B0081 · Motorized Treatment Chair with neckrest and cloth cover 1

9016B0451 · $ 1 $

9016B0252 · Head Stabilizer System (Special Vacuum Pillow and Evacuation Pump) $ 1 $Foot Rest Plastic Cover for treatment chair 9016B0261 · Pillow case (pack of 5 pcs.) 1 $

9016B0201 · Textile Cap, Small - 10 pcs. $ 1 $

9016B0211 · Textile Cap, Medium - 10 pcs. $ 1 $

9016B0221 · Textile Cap, Large - 10 pcs. $ 1 $

9016B0231 · Textile Cap, Extra Large - 10 pcs. $ 1 $

Training · Onsite installation and training Included Included

Sub-Total

*The MagVita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. (FDA k150641).

Training · Additional Training per day 9016E0361 · Theta Burst Option for MagPro R30

SUB-TOTAL (Excludes Options)

Shipping

GRAND TOTAL† (Excludes Options)

MagPro R30 & Cool B65 coil (MagVita TMS Therapy) system *

OPTIONS:

TOTALS

U5001 mailto:gail.cisneros@theinnovagroup.com Gail Cisneros Callout 120V_gc

Gail Cisneros Line

Sales Quotation: MYT601(b) - 2 -

MagVenture Inc. - 2300 Lakeview Parkway, Suite 700 - Alpharetta, Georgia 30009 - USA Phone: 888.624.7764 - Fax: 678.809.1415 - infousa@magventure.com - www.magventure.com

Initials _____

TRAINING

INSTALLATION

EW1

THE FOREGOING PRODUCT WARRANTIES AND REMEDIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHERS. EXCEPT AS SO STATED, MAGVENTURE DISCLAIMS ALL PRODUCT WARRANTIES, EXPRESS AND IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A

PARTICULAR PURPOSE.

No other warranties are expressed, written or implied.

Extended Warranty Option 1: 12 months purchased at time of sale of the Product. This warranty extends the standard warranty for a period of 12 months for a total of 24 months coverage. All labor and materials will be the responsibility of MagVenture. Freight inbound to MagVenture will be paid by customer and outbound to customer will be paid by MagVenture. Service will be available Monday-Friday from 9 am to 5 pm EST by an authorized technician at the MagVenture Facility. If after diagnosis by an authorized technician, it is determined that instrument requires service at MagVenture Facility, a service loaner will be provided at no charge. A no-charge preventive maintenance evaluation will be performed by a certified MagVenture Representative during the life of the 24 month warranty. The cost of the 12 month extended warranty and preventative maintenance is 12% of the list price of the Product, non-discountable and only available at time of Product sale.

MAGVENTURE, INC. - TERMS & CONDITIONS: USA SALES

PRODUCT SALE & SOFTWARE LICENSING

The price of the Products includes one day of on-site in-service training by a professional sales representative. MagVenture's local representatives and factory personnel are available for ongoing technical and service training, at an additional cost of $2,000.00 per day.

Products purchased by Customer hereunder (“Products") shall be newly manufactured. As between Customer and MagVenture, all intelectual property relating to Product is owned by MagVenture, and Customer shall not own or aquire any right, title or interest in or to the foregoing. Any software and/or firmware included with the Products is licensed (and not sold) to Customer. MagVenture grants to Customer a nonexclusive, nontransferable license to use such software and/or firmware in connection with Customer’s use of the Products. Customer may not modify, reproduce, duplicate, decompile, disassemble, reverse assemble, reverse compile or reverse engineer any software or firmware included with the Product. No other license, by implication or otherwise, is granted to Customer.

1 Day of Clinical and Technical on-site Training

The price of the Products includes installation by MagVenture, provided such installation occurs within 30 days after shipment (the “Installation Period”). Promptly after delivery, Customer must contact MagVenture to arrange a mutually convenient installation date during the Installation Period. MagVenture shall have no responsibility to install the equipment after the Installation Period and may charge an extra fee for any such requested services. Customer shall ensure that the installation site shall be prepared in accordance with any written direction provided by MagVenture.

MagVenture warrants solely to Customer, for 12 months from shipment of a Product by MagVenture (the "Warranty Period"), that such Product will be free from defects in workmanship and materials. This warranty is subject to proper use, storage, operation and maintenance of the Product in accordance with the operator manual, and shall not apply if the Product has been damaged after shipment to Customer, or misused, altered, disassembled, repaired or serviced by any person other than MagVenture. MagVenture's sole obligation under this warranty shall be, at MagVenture's option, to repair or replace any Product defect that was present when the Product was first shipped to Customer and of which Customer notified MagVenture in writing within the Warranty Period. If Product is determined by MagVenture not to be under warranty, Customer shall pay the cost of service. Products repaired or replaced under warranty and components thereof will be warranted as provided in this subsection for the remainder of the original Product's original warranty period. Notwithstanding anything to the contrary, software, firmware ; and products not manufactured by MagVenture and licensed herein will be warranted as provided in this subsection for ninety days from shipment of the applicable Product.

TRAINING & SERVICE

STANDARD WARRANTY

EXTENDED WARRANTY

The following terms and conditions are incorporated into, and are material part of, the Customer Purchase Agreement ("Agreement") between Customer and MagVenture, Inc. ("MagVenture"). All other terms and conditions are rejected. Terms and conditions on the face of the Agreement shall control over any conflicting or inconsistent terms and conditions in any of the following sections.

U5001

Sales Quotation: MYT601(b) - 3 -

MagVenture Inc. - 2300 Lakeview Parkway, Suite 700 - Alpharetta, Georgia 30009 - USA Phone: 888.624.7764 - Fax: 678.809.1415 - infousa@magventure.com - www.magventure.com

Initials _____

EW2

EW3

Extended Warranty Option 2: 24 months purchased at time of sale of the Product. This warranty extends the standard warranty for a period of 24 months for a total of 36 months coverage. All labor and materials will be the responsibility of MagVenture. Freight inbound to MagVenture will be paid by customer and outbound to customer will be paid by MagVenture. Service will be available Monday-Friday from 9 am to 5 pm EST by an authorized technician at the MagVenture Facility. If after diagnosis by an authorized technician, it is determined that instrument requires service at MagVenture Facility, a service loaner will be provided at no charge. 2 (two) no-charge preventive maintenance evaluations will be performed by a certified MagVenture Representative during the life of the 36 month warranty. The cost of the 24 month extended warranty and preventative maintenance is 18% of the list price of the Product, non-discountable and only available at time of Product sale.

EXTENDED WARRANTY (continued)

ORDER CANCELLATIONS & RETURNS

QUOTE VALIDITY: 30 days FOB: Atlanta, GA

ORDER CANCELLATIONS: Customer may cancel an order in whole or in part any time before original scheduled Shipment date; provided, that written notice of cancellation must be received by MagVenture prior to such date; and, Customer will be liable for a cancellation charge of ten percent of the net invoice price of the cancelled Products.

PRODUCT RETURNS: After original scheduled Shipment date Products may be returned only under warranty and only after Customer has obtained a Return Material Authorization (RMA) number from MagVenture. Returned Products must have the RMA number marked on the outside of the package, and must be shipped to the MagVenture with freight and insurance prepaid by Customer. Product returns are subject to a restock fee.

RESTOCK FEE : 40%…