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World Headquarters 

Millar Instruments, Inc. 

6001-A Gulf Freeway 
Houston, Texas 77023-5417 USA 
Phone:  832-667-7000 or 800-669-2343 (in the USA) 
Fax:      832-667-7001 
Email:   [email protected] 
Web site:  www.millarinstruments.com 
 

Millar Worldwide Distribution 

Millar Instruments, Inc. has a network of Authorized Distributors in most countries around the world. 
For information on the Millar distributor in your country, please contact the Millar Customer Service 
Department at our headquarters in Houston. 
 

European Authorized Representative 

Harald Hellmann 
DeMeTec GmbH 
Co: FMI 
Lützelwiesen 5 
35428 Langgöns 
+49-6403-7874-0 
Fax  -30 
GF: Dipl. Phys. Harald Hellmann 
AG Gießen: HRB-Nr. 2604 
Email:  

[email protected]

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

©

 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: 004-2184 Rev. -- 

 

 

0086 

 

OBSERVE PRECAUTIONS 

FOR HANDLING 

ELECTROSTATIC 

SENSITIVE DEVICES 

 

Sensors.Systems.Solutions.

®

 

 
 
 

 
 
 
 

Mikro-Tip

®

 Catheter Pressure Transducer 

 

Model SPC-721 

 

Instructions for Use 

 

NONSTERILE PRODUCT 

 
 
 

Cardiology catheters MUST be cleaned and sterilized with ethylene oxide gas prior to every use. 

Follow directions in this IFU. 

 

CAUTION

: Federal (USA) law restricts this device to sale by or on the order of a physician. 

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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