Mikro-Tip Ultra-Miniature Pressure-Volume Catheter Animal
Contents
1. CATHETER PREPARA TION EN 4 BRU TIN INSPECTION e EE Ehe 4 PRESSURE AL IBRA TION EE 4 VOLUME CUVETTE CALIBRATION E 5 EEN 6 OPERATING INSTRUCTIONS ic cckssssiessssasccdndcdecvassasscceseesdaasevanacebsdettuvasesancessicassescsatoeecpdsddecenensacenseeedsooausns 7 CCEANING EE 9 APPROVED CLEANERS AND DISIDNFBCTANTS 9 WATER RESISTANT CONNECTOR CAP 9 CLEANING Cen Ae RE 9 GENERAL INSTRUCTIONS FOR CATHETER DISINEFECTION eee eeeeeccceeeececeeeeees 11 RINSING AFTER DISINFECTION ebe hee 11 METHOD OF STERILIZATION FOR CATHETERS AND EXTENSION CABLES OPTIONAL 12 ETHYLENE OXIDE STERILIZATION CYCLE PARAMETERS sssssesssssessessesereessssrreessssrrtesssseeeessssereeeesseee 12 SEENEN 13 CATHETER SPECIFICATIONS eege 13 KE EE Re 14 LE E 15 SERVICE PROVISION EE 16 MILLAR LIMITED WAIRIRAIN EEN 16 Recommended Accessories M I P N 880 0127 MPCU 200 220V M I P N 880 0128 MPCU 200 110V M I P N 850 1308 TEC 10D Pressure Cable M I P N 850 5066 CEC 10A Volume Cable M I P N 880 0160 MPVS 300 M I P N 880 0159 MPVS 400 M I P N 850 5103 PEC 4D Pressure Cable M I P N 850 5099 CEC 4B Volume Cable M I P N 910 1048 Large Volume Calibration Cuvette M I P N 910 1049 Small Volume Calibration Cuvette 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 of2. Conformity Device Description The Mikro Tip Pressure Volume P V catheter combines an ultra miniature pressure sensor s and a series of electrodes mounted at various locations along the distal end of the catheter Figure 2 The catheter terminates at two electrical connectors at the proximal end The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure The electrodes allow for estimation of left ventricular volume changes by impedance measurements Mikro Tip catheters are intended for multiple uses Experience has proven that the instruments are safe and effective for extended service if proper handling cleaning and sterilization procedures are followed Immediately upon receipt of the catheter and prior to its initial cleaning sterilization and use the customer should verify that the catheter is operational Schematics f OS RY Z 7 Se W ON gt N ff ROP YA D fof far i V Ae A K OY IT 2 JCT IN i ff PA MF esche A Jim Ze IN e ll ZE l Vi ld WY ASR KIT We H ba on i f lt Ke N FNR JA i SS j i j pe J F GE FNY G Z SE 7X J t A Ree E EN LE Ss ES a Xs cay A PINS 14 Electrode amp Redel Connector 4 EXC 3 Sig 4 O Sensor amp Low Profile Connector 14 Sensor Specifications Intended Use Indications Use of the ultra miniature
3. Mikro Tip P V catheter being careful to handle it with a high degree of care Connect the pressure transducer connector on the Mikro Tip P V catheter to the pressure cable PEC 4D or similar Connect the conductance volume transducer connector on the Mikro Tip P V catheter to the volume cable CEC 4B or similar Using a shallow dish beaker or syringe soak the catheter tip in body temperature distilled water or saline for at least 30 minutes prior to insertion into the biological environment Set the Pressure Transducer Calibration Switch on the front panel of the Millar control unit MPCU 200 or MPVS 300 400 to 0 mmHg Set the Volume Transducer Relative Volume Units RVU Calibration Switch on the front panel of the Millar control unit MPCU 200 or MPVS 300 400 to 5 RVU For the MPVS 300 400 verify that the appropriate segment length has been selected using the Segment Select switch located on the front panel For standard four electrode P V catheters select the Short position For six electrode P V catheters select either the Short or Long position depending on the desired electrode spacing segment length Open the data acquisition software on the computer 7 16 I7 Configure the data acquisition software according to user preferences so that it can effectively acquire display and record the P V data produced by the Millar control unit MPCU 200 or MPVS 300 400 Calibration Setup Follow the inst
4. Mikro Tip P V catheter 1s indicated when combined physiological pressure FASC i Ca and volume as estimated by electrical impedance measurements monitoring is required in small SC EE Se animals such as mice and rats Type of Sensor Diffused Semiconductor piezoresistive Mikro Tip P V catheters may be introduced into the left ventricle using a closed chest carotid artery Pressure Range 50 to 300 mmHg 6 7 to 40 kPa Ta or using an open chest approach through an entry site made in the apex of the heart with a Overpressure 4000 mmHg 530 kPa 760 mmHg 100 kPa Proper catheter positioning within the left ventricle can be verified with the aid of echocardiography Rated Excitation 2 5 7 5 Voc or Vactms 2 0 10 0 Vpc or Vac rms Warnings Sensitivity 5 uV V mmH g nominal 37 6 pV V kPa e The Mikro Tip P V catheter should be stored in a cool dry place Temperature Error Band at Zero Pressure 3 mmHg 0 4 kPa BSL 23 38 C ae e The Mikro Tip P V catheter is shipped with a foam dome fitting over the catheter tip to Linearity and Hysteresis Combined 1 BSL of full scale 2 BSL of full scale protect the sensor electrode area The catheter tip should be left in the foam dome when Drift lt 6 mmHg 0 8 kPa in 12 hours the catheter is in the tray Bridge Resistance 1000 ohms nominal Proper handling of the Mikro Tip P V catheter is critical to avoid damage and Reference Pressure Atmosphere maximize the catheter s use l
5. Tip P V catheter is done soaking in the enzymatic cleaning solution thoroughly rinse the tip with fresh distilled water 5 After the rinsing is complete gently dry the Mikro Tip P V catheter according to the following steps e Fold a Kim wipe or similar soft tissue e Use gentle stroking to brush dry the catheter tip e Do not pull the catheter tip through a folded Kim wipe e Do not allow the catheter to air dry on the tray table or countertop 10 data acquisition sampling rate of 1 kHz 1000 samples second in order to accurately capture all of the features of the P V waveforms produced by the fast beating hearts of mice and rats To ensure activation of the catheter tip transducers make sure that both the Pressure Transducer Calibration Switch and Volume Transducer Relative Volume Units RVU Calibration Switch on the front panel of the Millar control unit MPCU 200 MPVS 300 400 are switched away from the calibration reference settings and are set to Transducer After the P V data has been collected by the data acquisition software please refer to the PVAN software user s guide for instructions on how to export P V data selections out of the data acquisition software to perform a comprehensive data analysis in PVAN Cleaning Approved Cleaners and Disinfectants Type Trade Name Manufacturer Active Soak Ingredient Time Temperature Enzymatic Enzol Advanced Propylene 15 minutes room Detergent in UK Sterilization Glyco
6. or Sterilization formaldehyde vapor solutions Remove plastic dome from catheter Use Sporox or Cidex PA solutions Troubleshooting and Corrective Action Catheter Clean immediately after use Excessive Deposit of foreign material on the Follow Cleaning Instructions If pressure signal diaphragm of the pressure sensor problem persists contact Millar drift Pressure sensor Moisture in the connector damage to Follow Operating Instructions or will not balance wires in the catheter or fractured substitute a transducer known to be zero strain gauge within pressure sensor operating properly into the recording system If problem persists contact Millar Noisy or erratic Damage to electrodes or electrode Follow Operating Instructions or substitute a transducer known to be operating properly into the recording system If problem persists contact Millar volume signal wire bond open electrode Method of Sterilization for Catheters and Extension Cables Optional CAUTION DO NOT sterilize by autoclaving radiation gamma or e beam plasma peroxide or formaldehyde vapor solutions Catheters must be completely cleaned and dried before sterilization Aerate at room temperature or in a heated aeration cabinet max 145 F 63 C Catheters may be sterilized in the white plastic shipping tray The foam dome and connector caps must be removed and placed alongside the catheter inside the pouch during sterilizati
7. At least 8 hours Temperature 110 10 F 43 C CAUTION The Mikro Tip transducer should not be used earlier than 5 days after sterilization 12 6 After the cleaning procedure is complete return the Mikro Tip P V catheter to its original packaging for storage e Return the catheter to the tray e Protect the sensor electrode area on the catheter tip by carefully placing it within the foam dome that came with the packaging e Slide the tray inside the box e Store the catheter in a cool dry place until the next use General Instructions for Catheter Disinfection 1 The catheter must be cleaned rinsed and dried prior to disinfection Soil debris proteins and water can interfere with the effectiveness of the following procedure posing a risk to the patient and the user Note that some disinfectants have a limited usable life after activation or opening the container Failure to heed such warnings can inhibit the effectiveness of the disinfection process 2 Prepare the disinfectant according to the manufacturer s instructions 3 Submerge the catheter into the disinfectant up to the strain relief Do not submerge the strain relief or the connector as it will damage the transducer and void the warranty 4 Soak the transducer in the disinfectant at the temperature and time intervals listed Rinsing after Disinfection 1 Rinse the device by submerging all exterior disinfected surfaces in sterile pyrogen free water T
8. 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 info millarmail com 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 FMI Fohr Medical Instruments GmbH In der Grube 13 D 64342 Seeheim Ober Beerbach Germany Telephone 49 0 62 57 96 22 60 Fax 49 0 62 57 96 22 62 8 20 17 Email info fmigmbh de LE 0086 OBSERVE PRECAUTIONS FOR HANDLING ELECTROSTATIC SENSITIVE DEVICES 2007 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 2102 Rev F Sensors Systems Solutions P Mikro Tip Ultra Miniature Pressure Volume Catheter Animal Use Only Instructions for Use Service Provision Consult web site below for service information www millarinstruments com Millar Limited Warranty Millar warrants t
9. biological debris may cause short term baseline drift and should be removed Such removal should consist of a thorough soaking in an enzymatic cleaning solution Terg A Zyme followed by a persistent and gentle wiping action along the sensor or electrodes with a moist tissue gauze or cotton tipped swab The connectors should undergo visual inspection for corrosion or bad contacts Liquid entering the connector s can cause electrical hazard erratic operation and corrosion Pressure Calibration Each transducer is calibrated for a standardized sensitivity of 5uV V mmHg 37 6 uV V kPa Since the transducer electrical calibration may be altered by the effects of variations in monitors calibration should be confirmed with a pressure manometer to help guarantee the most accurate results To properly calibrate and balance the Mikro Tip P V catheter pressure transducer follow the instructions for the Millar control unit being used MPCU 200 or MPVS 300 400 for more details please see the Operating Instructions section of this manual To confirm calibration accuracy compare the pressure output produced using the pressure manometer with the electrical output signal produced by the Millar control unit for the Mikro Tip P V catheter pressure transducer see Figure 3 for more detail Volume Cuvette Calibration The cuvette calibration method uses an actual blood sample to make a more accurate assessment of the left ventricular volume The cu
10. e before pulling the catheter out to insure the pressure sensor or electrodes do not catch on the suture and lift or tear away from the catheter e The Mikro Tip P V catheter should be cleaned immediately after each use see Cleaning e The pressure sensor element on the Mikro Tip P V catheter is sensitive to electrostatic discharge Refrain from touching the sensor element while the catheter is not connected to monitoring equipment Handling Precautions for Mikro Tip P V Catheters SR it a O Sa Pressure Clean immediately after use Clean with stiff bristled brush Sensor amp Clean with high pressure water jet Electrodes Protect with dome when not in use Tap the sensor or electrodes against a rigid surface Disconnect during electrical defibrillation Apply excessive force to the sensor or electrosurgery or electrodes Expose to excessive pressure Cut crease knot fold kink or crush with forceps or clamps of any kind Connectors Protect connectors from fluid Immerse connectors in liquid amp Cables Cleaning Keep catheter and sensor wet until Expose to alcohol cresols phenols cleaning mercury compounds hypochlorites acetone peroxide silicone chlorine xylenes trichloroethylene or freon Clean thoroughly with approved Use ultrasonic cleaner enzymatic cleanser immediately after use Immerse electrical connector Disinfection Dry catheter before sterilizing Autoclave irradiate gamma e or beam plasma peroxide
11. hat at the time of sale to the original purchaser the device shall be free from defects in materials and workmanship for a period of six 6 months from its date of shipment to the original purchaser If there is such a defect Millar will at no charge and at its option either repair or replace any Mikro Tip P V catheter as appropriate Millar s limited warranty does not cover damage to the product from alterations misuse abuse negligence or accident The user shall determine the suitability for use of these devices for research purposes only Therefore the user accepts these devices subject to all the terms hereof Furthermore Millar does not warrant that the equipment is suitable for any specific purpose other than that explicitly stated by Millar Furthermore Millar does not warrant its Mikro Tip P V catheter for use with signal conditioning hardware that is not manufactured by Millar Using the Mikro Tip P V catheter with signal conditioning hardware that is not manufactured by Millar will render the warranty null and void and the catheters will not be considered for evaluation or repair In addition Millar makes no warranty regarding device efficacy after three 3 years from the date of manufacture Catheters beyond the age of three 3 years will not be considered for evaluation or repair This warranty is in lieu of and excludes all other warranties not expressly set forth herein whether expressed or implied warranties of merchan
12. he cuvette calibration procedure listed below Procedure 1 Inthe data acquisition software calibrate the hardware output using the electronic RVU calibrator built into the Millar control unit MPCU 200 or MPVS 300 400 A linear two point calibration is recommended at 5RVU and 5ORVU for more details on RVU calibration please see the Operating Instructions section of this manual 2 During the course of the experiment withdraw fresh slightly heparinized blood from the experimental subject and inject the blood into the different tubes of a calibration cuvette insulated tubes with different diameters to a depth that will submerge the Mikro Tip P V catheter electrodes when the catheter is dipped in the tube NOTE Millar Instruments can provide standard calibration cuvettes for mice Part No 910 1049 and rats Part No 910 1048 Researchers who are interested in enhancing the accuracy of their volume calibrations may choose to fabricate their own cuvettes based on the size of their research animals 3 Dip the Mikro Tip P V catheter in the center of the blood filled tubes and record the conductance output in RVUs Keep the catheter centered in the tube cuvette If the bottom of the tube is not flat then be careful to keep all four electrodes in the cylindrical portion of the tube NOTE The blood used to perform the cuvette calibration must be free of saline or any other solution that may alter the conductance of the blood a
13. he electrodes and the pressure sensor case Always be mindful of the location of the catheter tip Do not set heavy objects or metal instruments on top of the Mikro Tip P V catheter Do not tighten sutures over the sensor electrode area on the Mikro Tip P V catheter When using the carotid artery approach to insert the Mikro Tip P V catheter into the left ventricle advance the sensor electrode area completely beyond the proximal suture before tightening the suture e When using the carotid artery approach to insert the Mikro Tip P V catheter into the left ventricle take care not to damage the catheter with the tips of any forceps or tweezers that are used to grip the artery when inserting the catheter e When using the open chest approach to insert the Mikro Tip P V catheter into the left ventricle do not push the catheter tip directly through the left ventricular wall First make an entry hole in the ventricular apex with a needle and then insert the catheter through the hole e Never apply excessive force when inserting the Mikro Tip P V catheter The catheter may incur damage and could puncture through the left ventricular wall or damage the aortic valve Usable Length Per package labeling Electrodes 0 25 mm 13 2 e If resistance is encountered while inserting the Mikro Tip P V catheter pull back slightly and then try advancing again e When removing the Mikro Tip P V catheter through the carotid artery loosen the proximal sutur
14. he volume of the water should be at least two gallons 7 6 liters and the soak time should be at least one minute 2 At least three separate rinses are required Do not reuse any of the water used for rinsing since it will be contaminated with the disinfectant 11 Maintaining Device Effectiveness Catheter Preparation Presoak the catheter tip in saline or distilled water maintained at body temperature for at least 30 minutes prior to use Only soak the catheter tip do not submerge the catheter s electrical connectors as doing so will damage the sensitive electronics housed inside The presoak helps prepare the pressure sensor diaphragm for the wet biological environment Presoaking the catheter tip in body temperature fluid also helps prevent pressure signal drift and negative pressure recordings The presoak can be done by gently inserting the catheter tip into a beaker or dish or through the tip of a syringe Routine Inspection CAUTION If damage is found during inspection DO NOT use the catheter Contact Millar Instruments or an authorized Millar distributor for assistance The Mikro Tip P V catheter should be thoroughly inspected under magnification before and after each use to determine its condition Carefully examine the catheter for cuts kinks or creases The active surface of the sensor and electrodes should be examined for any film blood or biological debris that has not been removed by cleaning Any film blood or
15. ife lt 10 uA at 180 Voc NETGEN e Use of the Mikro Tip P V catheter should be restricted to specialists who are familiar le P lt E EE lt 10 pA at 120 Vac E E with and have been trained to perform the catheterization procedures for which the Electrical Leakage ER Double Pressure lt 10 uA at 25 Voc lt 10 uA at 25 Voc Se RRRS e Do not under any circumstances bend kink fold cut pinch crush etc the Mikro Tip P V Zero Offset lt 50 mmHg 6 7 kPa catheter especially around the sensor electrode area These actions could severely damage the catheter and or render the catheter unusable and result in costly repair or replacement Performance specifications are for 5 Vpc Transient voltages up to 20 volts will not damage the charges transducer e The Mikro Tip P V catheter should be inspected for damage cracking kinks etc prior to each use Based on 30 minute presoak e Do not grip the Mikro Tip P V catheter with forceps tweezers or fingers anywhere near Catheter Specifications the sensor electrode area e When using metal forceps or tweezers to grip the Mikro Tip P V catheter slip some soft Pin to Electrode Resistance lt 15 ohms tubing over the tips of the metal instrument to cushion the interface between the Catheter Size Per package labeling instrument and the catheter body e Always grip the Mikro Tip P V catheter proximal to the sensor electrode area Never grip the catheter between the electrodes or between t
16. ing step Do not submerge the catheter connectors as moisture will damage the sensitive electronics that are housed inside 3 The Mikro Tip P V catheter should be thoroughly inspected under magnification after each use to determine its condition Carefully examine the catheter for cuts kinks or creases The active surface of the sensor and electrodes should be examined for any film or biological debris Any film may cause short term baseline drift and should be removed Such removal should consist of a thorough soaking in Terg A Zyme see below followed by a persistent and gentle wiping action along the sensor or electrodes with a moist tissue gauze or cotton tipped swab The connectors should undergo visual inspection for corrosion or bad contacts 4 Using an enzymatic cleaner on the distal portion of the Mikro Tip P V catheter is essential to preventing protein buildup on the pressure sensor and electrodes Without the use of an enzymatic cleaner a protein film will form on the pressure sensor that ultimately results in pressure signal drift Millar provides the following guidelines for using enzymatic cleaners with the ultra miniature P V catheters e Use a Millar approved enzymatic cleaning agent such as Terg A Zyme by Alconox www alconox com e Follow the manufacturer s instructions for mixing the Terg A Zyme solution e Soak the catheter tip in a beaker or syringe for 15 30 minutes in the Terg A Zyme solution e After the Mikro
17. l temperature Cidezyme Products J amp J Glycol temperature Dodecylbenzene temperature High Level Cidex Advanced Glutaraldehyde 1 2 hours 25 C Disinfectant Activated Sterilization 77 F Dialdehyde Products J amp J Solution Cidex OPA Advanced Ortho 16 30 minutes 20 C Sterilization phthalaldehyde 68 F Products J amp J MetriCide Metrex Glutaraldehyde 1 2 hours 25 C 77 F DO NOT USE e Glutaraldehyde solutions containing surfactants e g Cidex 7 or Cidex Plus 28 Day e Solutions containing hydrogen peroxide e g Sporox e 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 and disinfecting Remove caps prior to sterilization Save and reuse these caps each time the catheter is cleaned and disinfected Cleaning Procedure CAUTION DO NOT submerge the wye junction or connectors This will damage the catheter and void its warranty Wipe with cleaner and gauze CAUTION Use only the listed cleaners and disinfectants for the times temperatures indicated CAUTION Delays in rinsing greatly reduce cleaning effectiveness The electronic RVU calibrator built into the Millar control unit MPCU 200 or MPVS 300 400 provides a quick and efficient way of calibrating the system Units of conductance RVU umho uS can be converted into volume units by following t
18. nd affect the data unless you are developing calibration curves to help identify the changes in blood conductance that may be occurring as a result of introducing some type of compound drug etc 4 Correlate the known volumes calculated from the catheter electrode spacing and the cuvette tubes with their respective conductance outputs to plot a graph of volume vs conductance RVU 5 Obtain the equation of the line slope and y intercept and use it to convert conductance units RVU to volume units uL NOTE As an alternative to a two point calibration some researchers follow the rules of good statistical sampling and choose to perform a multiple point cuvette calibration of volume vs conductance This data can be recorded then plotted in a spreadsheet program such as Microsoft Excel to obtain the conductance RVU to volume uL calibration Please remember that the volume of blood within the animal as well as the size and number of calibration cuvettes used in the experiment limit the number of data points that can be acquired The cuvette calibration procedures listed above do not take into account the parallel volume contribution of the myocardium Please consult Millar s PVAN Pressure Volume Analysis user s guide for more details on how to obtain a value for parallel volume Operating Instructions l 10 KE 12 13 14 15 Unpack the hardware software and cables Inspect the equipment for any obvious
19. on The caps should be saved and reused each time the catheter is cleaned The tray with lid should be placed in a breathable polyethylene pouch e g 3M Steri Lok CAUTION The catheter should be completely dry before sterilization Ethylene Oxide Sterilization Cycle Parameters Preheat phase Starting Temperature 110 F 43 C min Duration 30 minutes Initial Vacuum 6 0 inHgA 20 3 kPa Rate 3 minutes Nitrogen Flush 2 cycles Nitrogen Addition to 28 0 0 5 inHgA 94 8 1 7 kPa Rate 1 4 0 5 inHgA min 4 7 1 7 kPa min Evacuation 6 0 0 5 inHgA 20 3 1 7 kPa Rate 1 0 0 5 inHgA min 3 4 1 7 kPa Conditioning Humidification 1 5 0 5 inHgA 5 1 1 7 kPa Steam Conditioning 10 min Humidity Dwell 30 5 min at 7 5 0 5 inHgA 25 4 1 7 kPa Relative Humidity 15 70 Ethylene Oxide Concentration 500 50 mg L Dwell Pressure 16 5 1 0 inHgA 55 8 3 4 kPa Dwell Time 2 hours Temperature 110 130 F 43 54 C Relative Humidity 30 70 35 44 nominal After Vacuum Vacuum 6 0 0 5 inHgA 20 3 1 7 kPa Rate 1 0 0 5 inHgA min 3 4 1 7 kPa Vacuum Hold 10 min Gas Wash A 4 cycles minimum Release 30 0 nHgA min 94 8 1 7 kPa Rate 1 4 0 5 inHgA min 4 7 1 7 kPa Vacuum 6 0 0 5 inHgA 20 3 1 7 kPa Rate 1 0 0 5 inHgA min 3 4 1 7 kPa Release Filtered Air 28 0 0 5 inHgA 94 8 1 7 kPa Rate 2 0 0 5 inHgA min 6 6 1 7 kPa Aeration Hot Cell Duration
20. ructions in the data acquisition software user s manual as well as Millar s PVAN user s guide to perform two point calibration procedures for both the pressure and volume channels For simplified electronic calibration verification use the transducer calibration controls on the front panel of the Millar control unit MPCU 200 or MPVS 300 400 to provide fixed voltage signal references for pressure 0 100 mmHg and volume 5 50 RVU that may be used to quickly perform the two point calibration procedure Remember that RVU verification is only for Relative Volume Units not absolute volume Conversion of Relative Volume Units into true volume units requires additional steps please refer to Millar s PVAN user s guide for additional instructions regarding volume calibration techniques Volume calibration for a given catheter may be performed using small tubes of known diameters a calibration cuvette which can be supplied by Millar Instruments filled with fresh slightly heparinized blood drawn from an experimental subject Validation of the volume estimates provided by the Millar hardware can be performed by other means e g by thermodilution flow probes hypertonic saline dilution echo etc CAUTION The zero output produced by placing the pressure control unit switch in the 0 18 mmHg position is an electrical zero not an atmospheric zero Pressure Transducer Balancing After the catheter tip has soaked for at least 30 minute
21. s set the Pressure Transducer Calibration switch on the front panel of the Millar control unit MPCU 200 or MPVS 300 400 to Transducer Unlock and adjust the Balance control knob for the pressure channel the catheter is connected to Use the Balance control knob to adjust the pressure transducer output while dipping the transducer just below the surface of distilled water or saline essentially a zero pressure environment Adjust the Balance control knob until the output signal reads approximately 0 mmHg as displayed by an indicator in the data acquisition software or similar monitor then lock the knob into position CAUTION Do not submerge the electrical connectors on the catheter For best stability and zero adjustment shield the sensor from bright ambient light during the balancing procedure and allow the catheter tip to soak in body temperature sterile water or saline for 30 minutes prior to insertion into the biological environment Zero balancing of the pressure transducer should be done prior to each catheterization procedure NOTE A pressure manometer mercury digital etc may also be used to check the zero balance of the transducer and calibrate the pressure output at two points To pressurize the transducer a manometer can be connected to one end of a hemostasis valve or Toughy Borst Luer adapter with flexible tubing Carefully slip the catheter through the other end of the valve adapter and seal the valve adapter around the ca
22. signs of external and or internal damage If anything is missing or the equipment seems to be damaged in any way contact Millar Instruments or the authorized Millar distributor in your area immediately Power up the computer that will be used to acquire and analyze the P V data and install the necessary software DAQ software Millar PVAN etc Connect the P V channel outputs on the back panel of the Millar control unit MPCU 200 or MPVS 300 400 directly to a computer USB cable for MPVS 400 or to the input channels on the data acquisition system using BNC BNC cables or BNC cables that terminate at a connector that is compatible with the data acquisition system MPCU 200 or MPVS 300 400 Turn on the data acquisition system Connect the power cord to the power input jack on the back of the Millar control unit MPCU 200 or MPVS 300 400 Please ensure the power cord conforms to the standards in the country of operation The end user may be responsible for providing his own power cords if the cords supplied by Millar are not sufficient for the country of operation Cords must connect to a grounded power outlet for safety Turn on the Millar control unit MPCU 200 or MPVS 300 400 Ensure that the Power Indicator located on the front panel lights up Connect the pressure cable PEC 4D or similar and volume cable CEC 4B or similar to the appropriate input connectors on the back of the Millar control unit MPCU 200 or MPVS 300 400 Unpack a
23. tability or fitness of purpose Since handling storage cleaning and sterilization of the product as well as factors relating to catheterization procedures and other matters beyond Millar s control directly affect the product and the results obtained from its use Millar shall not be liable for incidental or consequential loss damage or expense directly or indirectly arising from the use of this product 16 Figures A if E4 ES y Fe El L HL me E S a Figure 2 __ 10 Figure 3 Figure Legend 1 Pressure Sensing Area 6 Mercury Manometer 2 Wires to Connector I Tee Fitting 3 Vent to Connector 8 Plastic Dome 4 Catheter H Pressure Transducer Catheter 5 Silicone Rubber Diaphragm 10 To Recorder 15 Table of Contents RECOMMENDED ACCESSORIES uoicc eee cceec ce eseeccccescccccsccccccescccenucececcsecccuucccenssecccaesceeustecceaueseeenense 1 DEVICE DESCRIPTION iecc cee cceecceeseecccecececccccccscccccscccccssceccassccecssecceaueccecueseeceasececenteceeaueeeeenenss 1 INTENDEDUSEOINDICATIONS cece ceeeeccceseeccccccecceccecccuseccccsseccceuscecsseccenscceensecceaueesecseess 2 WARNINGS EE 2 EECHER 2 HANDLING PRECAUTIONS FOR MIKRO TIP P V CATHETERS iiiiinosnnnssonnsssensseesssserssesrrseers 3 TROUBLESHOOTING AND CORRECTIVE ACTION 3 MAINTAINING DEVICE EFFECTIVENESS 0o occ ceeecceseeccccecececceseccceucececsesecccaucececsuneceeeaeecensens 4
24. theter shaft proximal to the sensor electrode area See Figure 3 for more detail 19 The system is now ready to begin conducting P V experiments Prepare the experimental subject for catheter insertion according to the lab s established experimental protocols When the experimental subject is ready insert the Mikro Tip P V catheter into the left ventricle and begin recording P V data Please Note Millar Instruments recommends a 8
25. ube is given in Figure 1 e L distance between electrodes 2 3 Catheter Model PVR 1045 L 4 5 mm Catheter Model SPR 839 L 4 5 mm Catheter Model SPR 869 L 6 0 mm Catheter Model s SPR 838 amp SPR 847 L 9 mm e The actual volume between electrodes 2 3 n r L e r inner radius of cylinder Insulated Tube L 4 5mm SPR 839 L 9 Omm SPR 838 Sensor Vol Cylinder ar r ails Calibration Cuvette Figure 1 1 After the P V loop data acquisition is complete immediately remove the Mikro Tip P V catheter from the biological environment When using the carotid artery approach loosen the proximal suture before pulling the catheter back through the blood vessel Loosening the proximal suture will help prevent the electrodes and pressure sensor from catching on the suture and breaking 2 Upon removing the Mikro Tip P V catheter from the biological environment immediately soak the catheter tip in a beaker syringe or dish filled with fresh saline or distilled water Keep the tip soaking until you are ready to continue cleaning it or you are ready to catheterize another research subject This step will help lyse any cells that adhere to the catheter and help loosen and prevent clot formations and protein build up on the catheter tip NOTE Never let blood dry on the catheter tip Always keep the tip soaking in saline or distilled water between experiments or until you are ready to proceed with the next clean
26. vette calibration method involves using insulator type cuvettes of known diameter filled with heparin treated blood Figure 1 illustrates the procedure for measuring volume using the conductance method when a four electrode catheter is submerged in a cylindrical non conductive tube filled with a conductive solution Conductance Volume readings can be obtained by submerging the catheter electrodes into blood filled tubes of known diameter The cuvette calibration is recommended for researchers who are interested in obtaining a more accurate assessment of left ventricular volume Researchers can enhance the accuracy of their volume measurements by coupling the acquired calibration data with their own mathematical models and or physical simulations to convert the volume measurements derived from the Millar hardware MPCU 200 or MPVS 300 400 into what they believe are the true volumes present within the left ventricle The cuvette calibration can dramatically affect the quality of the volume measurements Many factors must be addressed to make the cuvette calibration as accurate as possible These factors include maintaining the cuvette at body temperature minimizing blood clotting in the cuvette properly cleaning the cuvette before performing the experiment and centering the catheter within the cuvette The volume measured by the conductance method when a four electrode catheter is submerged into a cylindrical non conductive e g Plexiglas t
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