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Recommended Accessories 

M.I. P/N: 851-5918, Model TC-510 Control Unit, No patient isolation 
M.I. P/N: 880-0129, Model PCU-2000 Control Unit with Patient Isolation 
M.I. P/N: 850-1118, Model TEC-5C Extension Cable 
M.I. P/N: 850-1108, Model TEC-10C Extension Cable 
M.I. P/N: 850-1308, Model TEC-10D Extension Cable 
M.I. P/N: 850-5088, Model PEC-1.5C Extension Cable to PCU-2000 
M.I. P/N: 850-5089 Model PEC-10C Extension Cable to PCU-2000 
M.I. P/N: 850-5103, PEC-4D Extension Cable to PCU-2000 
M.I. P/N: 850-5090, PEC-10D Extension Cable to PCU-2000 
Monitor Input Cables as appropriate for monitor. 

All accessories sold separately. 

 

 

Definition of Symbols 

 

Attention, consult accompanying documents 

 

Date of Manufacture 

 

Catalog Number 

 

Serial Number 

 

Batch Code 

 

Use By Date 

 

Electrostatic Sensitive Device 

 

EU Declaration 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 uses. The instruments are safe and effective for 
extended service if proper handling, cleaning and sterilization procedures are followed. 
 
Extension cables are available for connection between the pressure connector and the pressure control 
unit. Cables may be sterilized. 

Intended Use / Indications 

Use Mikro-Tip catheters when measuring physiological pressures for diagnostic or other purposes in 
the cardiovascular system. These measurements may be made in conjunction with fluid sampling or 
injection. 

 

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Schematics 

 

 
 
 
 
 
 
 
 
 
 

Figures 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Sensor & Viking Connector

 

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7

4

Figure 2 

 

1

5

4

3

2

 

Figure 1 

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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