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Millar Mikro-Tip Catheter Pressure Transducer, Инструкция по эксплуатации

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11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

14

4

13

8

10

 

 

Figure 3b 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Pressure 

Sensing 

Area 

  8.  Manometer 

2. 

Wires to Connector 

 

9. 

Tee Fitting 

3. 

Vent to Connector 

 

10. 

Plastic Dome 

4. Catheter 

  11. Pressure 

Transducer 

Catheter 

5. 

Silicone Rubber Diaphragm 

 

12. 

To Recorder 

6. Pressure 

Sensor 

  13. Connector 

7. Adapter 

  14. Syringe 

8

9

11

12

10

 

Figure 3a 

Table of Contents 

 

RECOMMENDED ACCESSORIES ................................................................................................... 1

 

DEVICE DESCRIPTION ..................................................................................................................... 1

 

INTENDED USE / INDICATIONS ..................................................................................................... 1

 

CONTRAINDICATIONS ..................................................................................................................... 2

 

COMPLICATIONS ............................................................................................................................... 2

 

WARNINGS ........................................................................................................................................... 2

 

PRECAUTIONS .................................................................................................................................... 3

 

ADVERSE EVENTS ............................................................................................................................. 3

 

MAINTAINING DEVICE EFFECTIVENESS .................................................................................. 3

 

S

TORAGE

 .............................................................................................................................................. 3 

P

LASTIC 

D

OME 

F

ITTING

 ....................................................................................................................... 3 

ROUTINE INSPECTION AND TESTING ........................................................................................ 3

 

C

ATHETER

 ............................................................................................................................................ 3 

P

RESSURE 

S

ENSOR

(

S

) ........................................................................................................................... 3 

C

ONNECTOR

(

S

)

 AND 

C

ABLE

(

S

) ............................................................................................................ 4 

T

RANSDUCER 

V

ERIFICATION AND 

S

ETUP

 ............................................................................................ 4 

OPERATING INSTRUCTIONS WHEN USING A MILLAR PRESSURE CONTROL UNIT .. 4

 

OPERATIONAL NOTES ..................................................................................................................... 5

 

P

HONOCARDIOGRAM 

R

ECORDING

 ....................................................................................................... 5 

H

ANDLING 

P

RECAUTIONS FOR 

M

IKRO

-T

IP 

C

ATHETERS

 ..................................................................... 6 

T

ROUBLESHOOTING AND 

C

ORRECTIVE 

M

AINTENANCE

 ...................................................................... 6 

CLEANING ............................................................................................................................................ 6

 

A

PPROVED 

C

LEANERS

 ..........................................................................................................................  6 

W

ATER 

R

ESISTANT 

C

ONNECTOR 

C

APS

 ............................................................................................... 7 

C

LEANING 

P

ROCEDURE

 ........................................................................................................................ 7 

M

ETHOD OF 

S

TERILIZATION FOR 

C

ATHETERS AND 

E

XTENSION 

C

ABLES

 ........................................... 8 

E

THYLENE 

O

XIDE 

S

TERILIZATION 

C

YCLE 

P

ARAMETERS

 .................................................................... 8 

SENSOR SPECIFICATIONS .............................................................................................................. 9

 

SCHEMATICS ..................................................................................................................................... 10

 

FIGURES .............................................................................................................................................. 10

 

SERVICE PROVISION ...................................................................................................................... 12

 

MILLAR LIMITED WARRANTY ................................................................................................... 12

 

 

Содержание Mikro-Tip Catheter Pressure Transducer

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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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