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5

 

Operational Notes 

CAUTION: 

Use appropriate size introducer for catheter being used. 

 

 

CAUTION: 

Use of an introducer smaller than 16 gauge can result in damage to the catheter on 
removal. 

 

 

CAUTION: 

Consider use of systemic heparinization. 

 

Phonocardiogram Recording 

Mikro-Tip catheters have pressure sensors with a sufficiently high frequency response to sense heart 
sounds. These transducers detect sounds simultaneously from many sources in a localized fashion. 
Heart sounds visible on the pressure waveform can be amplified and clearly displayed on a separate 
channel. Heart sounds less than the noise of the display system will display only that noise. 

 

6

Handling Precautions for Mikro-Tip Catheters 

 

DO: 

DO NOT: 

Pressure 
Sensor 

Clean immediately after use 

Clean with stiff-bristled brush 
Clean with high pressure water jet 

Protect with dome when not in use 

Tap the sensor against a rigid surface 

Disconnect during electrical defibrillation 
or electrosurgery 

Apply excessive force to the sensor 
surface 
Expose to excessive pressure 

Catheter  

Clean immediately after use 

Cut, crease, knot, fold, kink, or crush 
with forceps or clamps of any kind 

Connector 
& Cables 

Protect connectors from fluid 

Immerse 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, irradiate (gamma/e-
beam), plasma, peroxide or 
formaldehyde vapor solutions 

Remove plastic dome from catheter 

Use Sporox or Cidex PA solutions 

 

Troubleshooting and Corrective Maintenance 

Problem 

Probable Cause 

Corrective Action 

Excessive Drift 

Deposit of foreign material on the 
diaphragm of the pressure sensor. 

Follow Cleaning Instructions. If 
problem persists, contact Millar. 

Transducer will 
not balance 
(zero) 

Moisture in the connector, damage to 
wires in the catheter, or fractured 
strain gauge within pressure sensor. 

Follow Operating Instructions or 
substitute a transducer known to be 
operating properly into the recording 
system. 

Cleaning 

Approved Cleaners 

Type 

Trade Name 

Manufacturer 

Active 
Ingredient. 

Soak 
Time/Temperature 

Enzymatic 
Detergent 

Enzol

®

 

(in UK: Cidezyme

®

Advanced 
Sterilization 
Products (J&J) 

Propylene 
Glycol 

15 minutes / room 
temperature 

Endozime

®

 Ruhoff 

Corporation 

Propylene 
Glycol 

15 minutes / room 
temperature 

Terg-A-Zyme

®

 Alconox 

Sodium 
Dodecylbenzene 

15 minutes / room 
temperature 

 

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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