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Service Provision 

Consult web site below for service information: 
 

www.millarinstruments.com

 

 

Millar Limited Warranty 

Millar Instruments, Inc. (Millar) warrants that at the time of sale to the original purchaser, the device 
was free from defects in both materials and workmanship. For a period of 365 days (1-year) from the 
date of original shipment to the original purchaser, Millar will, at no charge and at its option, either 
repair or replace any Mikro-Tip transducer found to have been shipped with defects in either 
materials or workmanship. Our warranty does not cover damage to the product from alterations, 
misuse, abuse, negligence, or accident.  
 
Millar hereby excludes all warranties not herein stated, whether express or implied by operation of 
law or course of dealing or trade usage or otherwise, including but not limited to any implied 
warranties of fitness or merchantability.  
 
Since handling, storage, cleaning and sterilization of the product, as well as factors relating to patient 
diagnosis, treatment, catheterization procedures, and other matters beyond Millar’s control, directly 
affect the product and the results obtained from its use, Millar shall not be liable for any incidental or 
consequential loss, damage, or expense arising directly or indirectly from the use of this product. 
 
The user shall determine suitability for use of these medical devices for any surgical or clinical 
procedure. Therefore, the user accepts these devices subject to all the terms hereof. Further, Millar 
makes no warranty regarding device efficacy after three (3) years from the date of manufacture. 
 
 

Summary of Contents for Mikro-Tip Catheter Pressure Transducer

Page 1: ...GF Dipl Phys Harald Hellmann AG Gießen HRB Nr 2604 Email info fmigmbh de 2008 Millar Instruments Inc All rights reserved Millar Mikro Tip and Sensors Systems Solutions are registered trademarks of Millar Instruments Inc Products and company names used are the trademarks or trade names of their respective companies Models referred to herein are protected by USA and International patents M I P N 004...

Page 2: ...rein stated whether express or implied by operation of law or course of dealing or trade usage or otherwise including but not limited to any implied warranties of fitness or merchantability Since handling storage cleaning and sterilization of the product as well as factors relating to patient diagnosis treatment catheterization procedures and other matters beyond Millar s control directly affect t...

Page 3: ...EVICE EFFECTIVENESS 3 STORAGE 3 PLASTIC DOME FITTING 3 ROUTINE INSPECTION AND TESTING 3 CATHETER 3 PRESSURE SENSOR S 3 CONNECTOR S AND CABLE S 4 TRANSDUCER VERIFICATION AND SETUP 4 OPERATING INSTRUCTIONS WHEN USING A MILLAR PRESSURE CONTROL UNIT 4 OPERATIONAL NOTES 5 PHONOCARDIOGRAM RECORDING 5 HANDLING PRECAUTIONS FOR MIKRO TIP CATHETERS 6 TROUBLESHOOTING AND CORRECTIVE MAINTENANCE 6 CLEANING 6 A...

Page 4: ...eclaration of Conformity Device Description Mikro Tip catheters consist of an ultra miniature pressure sensor s at the distal end of a catheter as shown in Figure 1 with an electrical connector s at the proximal end The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound Mikro Tip catheters are intended for multiple us...

Page 5: ... Vascular injury Protamine reaction Congestive heart failure Death Warnings CAUTION Mikro Tip catheters must be cleaned and sterilized prior to clinical use Use only with CE approved monitoring equipment that has patient isolated input circuitry type CF patient applied part per EN 60601 1 The monitoring equipment used should be compliant to relevant harmonized standards Patient isolated input is n...

Page 6: ...nd Testing CAUTION If damage is found during inspection DO NOT use the catheter Contact Millar Instruments or authorized distributor Catheter Inspect each catheter thoroughly before and after each use Carefully examine the catheter for defects Pressure Sensor s Examine the pressure sensor active surface diaphragm for blood or materials not removed by cleaning A dirty sensor may cause short term ba...

Page 7: ...ts apply a reference pressure signal to adjust sensitivity or to specific monitor requirement Use a mercury manometer or pressure reference device as shown in Figure 3a or 3b Apply a known pressure to the Millar catheter and verify the signal at the monitor Follow the instructions for the Millar pressure control unit being used Set up the mercury manometer as shown in 3a or 3b and compare the 100 ...

Page 8: ...merse connectors in liquid Cleaning Keep catheter and sensor wet until cleaning Expose to alcohol cresols phenols mercury compounds hypochlorites acetone peroxide silicone chlorine xylenes trichloroethylene or freon Clean thoroughly with approved enzymatic cleanser immediately after use Use ultrasonic cleaner Immerse electrical connector Sterilizing Dry catheter before sterilizing Autoclave irradi...

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