Transonic Original Equipment Manufacturing OEM Products

Original Equipment Manufacturers Products

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Transonic Flowboards & Flowsensors

Catalog Excerpts
A. Transonic Inside . . . . . . . . . . . . . . B. Transonic Inside Co-Engineering Program C. Transonic Inside OEM Flowboards . . . . . D.

................ ................ ................ Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Transonic Systems Inc.

OEM-1-cat 2010

The Flow Measurement Specialists

Contact your local representative at www.transonic.com/customerservice Transonic USA Headquarters: Tel: 607-257-5300; Fax: 607-257-7256

Transonic Original Equipment Manufacturing

A. Transonic Inside OEM System Consists of:

OEM Products

A Custom Transonic Circuit Board A Custom Transonic Flow Sensor

1. Custom Transonic OEM Flowboards mount inside an OEMs Device and draw DC
power from the Device Power Supply. These are standard OEM Flowboards with: Software modifications to accept only the Customized Flow Sensor selected by the OEM; Communication protocols, as selected by the OEM; Analog and/or digital data outputs that may implement any standard Transonic Flowmeter feature (volume flow sensing, bubble detection liquid properties measurement, sensor diagnostics)

2. Custom Transonic Flowsensors typically evolve from any standard Transonic Flow
Sensor (sterile tubing clamp-on, inline, or perivascular) to minimize re-engineering costs. They are: Labeled and numbered as products of the OEM (to assure that service and reordering proceeds via the OEM) Customized with connector and cable for the OEM, and calibrated for OEM use conditions. Programmed to be only compatible with a Transonic OEM Flowboard

3. Regulatory Approvals
Custom Transonic OEM Flowboard and Flow Sensor derive from standard Transonic products. Therefore, Medical Device Approval, FDA clearance and Clinical Performance Validation have a broad database of independent Transonic validation publications, historical safety and effectiveness records and substantial equivalency data. Transonics regulatory staff will assist OEM customers with obtaining regulatory approvals.

4. Transonic Inside Performance Guarantee

Because all Transonic Inside products are derived from standard Transonic components, their performance in an OEM setting can be assessed before the formal onset of a custom OEM project by using off-the-shelf Transonic Flow Sensors and Flowmeters. Transonic guarantees that its custom OEM products, when developed and implemented under Transonics co-engineering program, will match the performance of these products.

5. Typical Applications
Bypass Pumps; Ventricular Assist Devices; ECMO Apparatus; Infusion/Transfusion/Perfusion Systems; Dialysis Apparatus

Transonic Systems Inc.

OEM-1-cat 2010

The Flow Measurement Specialists

Contact your local representative at www.transonic.com/customerservice Transonic USA Headquarters: Tel: 607-257-5300; Fax: 607-257-7256

Transonic Original Equipment Manufacturing B.Transonic Inside Co-Engineering Program OEM Products
Transonic offers the following program for implementation of a Transonic custom flowmetering module into a new product. This program allows the OEM customer to:
evaluate Transonic apparatus in the OEM device to define specifications define and implement a custom flowmetering module in a device at minimal cost and time

Proof-of-Concept Testing
The OEM purchases a standard Transonic flowmeter and flowsensor. This system is used to perform extensive quality testing to define the attainable specifications of the flowmetering technology in the OEM device. After testing is completed, the flowmeter and flowsensor remain as the measurement standard with the OEM. (See specification sheet for standard Transonic
Flowmeters and Flow Sensors.)

Co-Engineering Program
1) OEM signs a non-disclosure agreement with Transonic Systems Inc. 2) Transonic & OEM mutually define project specifications based upon OEMs tests and requirements. 3) Transonic submits a Development Agreement to the OEM. The Development Agreement defines the customized OEM flowmeter product and its development time line, and includes a quotation for Transonics one-time NRE charges and product prototypes. It includes design review, any added development fees to meet pre-established specifications, and includes training and troubleshooting to bring the project to a successful completion. Prototype board and sensor pricing is also indicated (initial protype run is 10 units) along with a timeline for project development. 4) Transonic submits a draft Supplier Agreement that describes the terms and conditions under which customized OEM flowmeter products will be delivered upon project completion. 5) OEM signs and submits the Development Agreement and a purchase order (PO) to Transonic. (Transonic Systems requires a 50% deposit for development fees.) 6) Transonic designs and builds custom prototype flowmetering systems.
A custom version of the standard flowmetering system (prototype board) can often be delivered within 12 weeks after receipt of the purchase order. The timeline of the project depends on its complexity. Off-the-shelf OEM boards may be available with shorter lead times. its performance with the measurement standard flowmeter.

7) Meanwhile, the terms of the Supplier Agreement may be refined and the Agreement signed. 8) OEM receives prototype flowmetering system, compares its performance with the measurement standard flowmeter, and performs field trials. 9) OEM processes government approvals with assistance from Transonic Systems 10) Upon prototype approval, Transonic engineering releases the OEM Master File to Transonic Manufacturing. Production commences. 11) Transonic delivers flowboards and flowsensors. 12) With time, manufacturing of components by Transonic may be replaced by manufacturing of those components by the OEM under license.

Transonic pledges that its OEM modules will match

the superior quality criteria of its standard flowmeters.

Transonic Systems Inc.

OEM-1-cat 2010

The Flow Measurement Specialists

Contact your local representative at www.transonic.com/customerservice Transonic USA Headquarters: Tel: 607-257-5300; Fax: 607-257-7256

Transonic Original Equipment Manufacturing C.Transonic Inside OEM Flowboards

Standard Transonic Flowboards are available. Customized Flowboards may be manufactured to meet various size or power requirements, with failsafe redundant circuitry, for different environmental conditions, or to meet stringent design class requirements.

OEM Products

AFPT1045-00X
Flowboard for use with an external host controller. No onboard software/protocol validation required.

Board Size Power

Requirements

5.25(133.4) x 3.937(100) x 0.50(12.7) 8VDC, +5VDCat 3.5 Watts 5V analog SPI bus Flow, Signal Quality, Indicator Dilution 1PXN-25PXN Inline Flowsensors 5000v isolated transducer connection for Perivascular Flowprobes (Optional) 300KHz - 14.4MHz Performed by monitoring signal quality

Output Interface Control Interface Outputs

Transducers 2XL-20XL Sterile Tubing Flowsensors; Patient Isolation Transducer Frequency Bubble Detection

AFPT1060-00X
Stand alone Flowboard with internal microcontroller, factory programmed for OEM sensors, OEM interface protocols, and data output needs.

Board Size Power

Requirements

3.60(91.4) x 2.00(50.8) x 0.49(12.5) 9.0-14.0 VDC at 1 Watt SCI, 5V Analog None Flow, Signal Quality, Indicator Dilution, Status (SCI only) 2XL-20XL Sterile Tubing Flowsensors; 600KHz - 7.2MHz Performed by monitoring signal quality

Output Interface Control Interface Outputs

Transducers 3PXN-25PXN Inline Flowsensors Transducer Frequency Bubble Detection

Transonic Systems Inc.

OEM-1-cat 2010

The Flow Measurement Specialists

Contact your local representative at www.transonic.com/customerservice Transonic USA Headquarters: Tel: 607-257-5300; Fax: 607-257-7256

Transonic Original Equipment Manufacturing D. Transonic Inside OEM Documentation

CE-mark certification for the clamp-on sensor as a Class IIb device; a statement attesting to Transonic ISO9001 and EN46001 certification as audited by BSI; a statement certifying that the flowmeter circuit board is designed under the Transonic Quality System and is equivalent in design and performance to Transonic Systems HT110 flowmeter, a Class IIb device under Medical Device Directives, and is equivalent in design and ultrasound performance to Transonic devices marketed in the USA under FDA product clearance. Documentation of the Transonic equipment (boards and sensor) for the QA tests to meet CE mark requirements, for the assembled OEM apparatus.
BSI
S

OEM Products

TERE D

ISO9001 Certified

For information about Transonic Inside OEM Systems:

contact:

Doug Collins, Manager, OEM Products Transonic Systems Inc. 34 Dutch Mill Road Ithaca, NY 14850 Fax: 607-257-7256 E-mail: doug.collins@transonic.com

1-800-353-3569 (USA) 1-607-257-5300 (Worldwide)

Transonic Systems Inc. Transonic Systems Inc.

The Flow Measurement Specialists The FlowMeasurement Specialists
Contact your local representative at www.transonic.com/customerservice Transonic USA Headquarters: Tel: 607-257-5300; Fax: 607-257-7256 Transonic USA Headquarters: Tel: 607-257-5300; Fax: 607-257-7256
Contact your local representative at www.transonic.com/customerservice

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