Millar Mikro-Tip Catheter Pressure Transducer Instructions For Use Manual Download Page 7

 

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DO NOT USE: 

 

Glutaraldehyde solutions containing surfactants (e.g., Cidex 7 or Cidex Plus 28 Day) 

 

Solutions containing hydrogen peroxide (e.g. Sporox) 

 

Cidex PA solution 

Water Resistant Connector Caps 

Each catheter has water-resistant caps to protect electrical pins and circuitry. Place caps over the open 
end of the connectors before cleaning. Remove caps prior to sterilization. Save and reuse these caps 
each time the catheter is cleaned. 

Cleaning Procedure 

CAUTION: 

DO NOT submerge the connector. This will damage the catheter and void its 
warranty! Wipe with cleaner and gauze. 
 

CAUTION: 

DO NOT pull on the sensor tip end of the catheter while cleaning, wiping, or 
drying the catheter. 

 

CAUTION: 

Use only the listed cleaners for the times/temperatures indicated. 

 

CAUTION: 

Delays in rinsing greatly reduce cleaning effectiveness! 

 

1.

 

Wipe catheter with wetted gauze. 

2.

 

Submerge only the distal contaminated portion of the catheter in room-temperature 
water (DO NOT use hot water) up to the connector’s strain relief. 

3.

 

Wipe the proximal outer surface of the catheter (including connector) with soft 
gauze. 

4.

 

Prepare cleaning solution. Place the distal portion of the catheter in the cleaning 
solution. 

5.

 

Wet soft surgical gauze with the cleaning solution. Wipe the outer surface of the 
catheter with gauze. 

6.

 

Soak distal portion of the catheter in a cleaning solution for the time specified, and 
then remove.  

7.

 

Gently wipe the catheter and sensor clean with a soft, wet gauze or tissue.  

8.

 

Immediately rinse the catheter and sensor(s) at least three times with sterile, 
pyrogen-free water. Do not reuse the water from each rinse, as it will contain 
residuals from the cleaner. 

9.

 

Dry the outside of the catheter with soft gauze.  

10.

 

Package for sterilization.  

11.

 

Failure to clean and sterilize according to directions may void catheter warranty. 

 

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Connector(s) and Cable(s) 

The connector(s) should be routinely inspected for corrosion or bad contacts. Liquid entering the 
connector(s) can cause electrical hazard, erratic operation and components corrosion. 

 

Transducer Verification and Setup 

CAUTION: 

DO NOT handle or squeeze the pressure transducers during catheter manipulation! 

 
Each transducer is calibrated for a standardized sensitivity of 

5

μ

V/V/mmHg (37.6 

µ

V/V/kPa)

 
To verify system outputs, 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 mmHg (13.3 kPa) output produced using the mercury 
manometer with the electrical 100 mmHg (13.3 kPa) produced by the control unit. 
 
Reading errors at or near the 0 mmHg (0kPa) manometer indication can be minimized by offsetting 
the manometer zero indication to 20 mmHg (26.6 kPa) and using the 100 mmHg (133 kPa) 
increments from the 20-120 mmHg (26.6 – 160 kPa) pressure indication rather than the 0-100 mmHg 
(0-133 kPa) pressure indication. 
 
Errors due to inconsistent meniscus shape between consecutive readings can be minimized by 
adjusting the pressure at each reading to maintain a consistent curve at the top of the meniscus. These 
errors may be avoided by using an electronic pressure meter as shown in Figure 3b. 

Operating Instructions 

When Using a Millar Pressure Control Unit

 (see Control Unit’s IFU) 

1.

 

Soak the sensor in room-temperature sterile water or sterile saline for 30 minutes prior to 
use to minimize drift. 

2.

 

Connect the Millar pressure control unit to the monitor. 

3.

 

Turn the pressure control unit function switch to STANDBY 0 and adjust the monitor to 
zero baseline. 

4.

 

Turn the pressure control unit function switch to 100 mmHg and adjust the monitor 
sensitivity. 

5.

 

Connect the extension cable to the pressure control unit. 

6.

 

Connect the catheter to the extension cable. 

7.

 

Turn the pressure control unit function switch to TRANSDUCER. Shield the sensor from 
light. Adjust the TRANSDUCER BALANCE CONTROL to zero baseline. LOCK the 
catheter balance. 

8.

 

The catheter system is now ready for use. 

 
Monitor ZERO-REFERENCE can be verified by setting the Millar pressure control unit selector 
switch to STANDBY 0 to reproduce the original zero baseline. Monitor zero baseline adjustment can 
be performed at this time if required. Monitor GAIN can then be verified by setting the selector 
switch to the 100 mmHg (13.3 kPa) position on the control unit. Monitor GAIN adjustments can be 
made at this time if required. 
 

CAUTION: 

The “zero” output produced by placing the control unit function switch in the 
STANDBY 0 position is an electrical zero, not an atmospheric zero! 

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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