EndoFLIP® EF-322 Catheter Models: EF-322 EF
Contents
1. CROSPON EndoFLIP EF 322 Catheter Models EF 322 EF 322N Instructions for Use Table of contents 1 MOCO ice cessed cece ER EE TE 4 EN ANTOK 4 t2 Intended Ust Lane 5 T3 COMUPAMICICAUOINS naea EE 5 VATNE 5 2 USING ThE Catheter chisncnara cides A eta woes 6 2 1 Installing the catheter assembly rrrrnnnnnnrrrnnnnnrrrnnnnnrrrnnnnnnrrnrnnner 6 2 2 Placing the catheter Esophageal Diameter measurements 7 23 Disconnecting the catheter iiccsccccdeccacsaxdesdarssvcieiasessadandeevsdiavenees 8 ADDENCIK AS SPECITICATIONS a pases esa dressene aars edlrd 9 Copyright 2014 Crospon Ltd This document is the sole property of Crospon Ltd No part of this document may be copied or otherwise reproduced or stored in any electronic information retrieval system without the prior consent of Crospon Ltd EndoFLIP EsoFLIP and FLIP are registered trademarks of Crospon Ltd EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A iii 1 Introduction The EndoFLIP EF 322 Catheter is designed for use with the EndoFLIP System which displays estimates of the diameters at 16 points over a 16cm measurement length along the balloon This catheter has an integrated pressure sensor for balloon pressure measurement Throughout this document the EF 322 will also describe the use of the EF 322N which is the same catheter but with a different packaging option 1 1 How it works The EF 322 Catheter acts as a Functio2. doFLIP EF 322 Catheter Instructions for Use DD 700 Rev A 11 12 EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A
3. e five center Dests Once the balloon has been positioned a non zero pressure may occur as a result of the positioning You may zero the pressure displayed before starting balloon inflation 5 When the procedure is finished deflate the balloon fully as indicated when the plunger aligns with the arrow on the syringe See Fig 4 and carefully remove the catheter from the patient Catheter assembly Catheter balloon Catheter markings are p referenced from the most distal Dest 0 last Dest Figure 3 Zero Reference for catheter markings EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A 7 Syringe returned to original position plunger aligns with arrow a 1 Ss Figure 4 Syringe returned to original position Warning In the unlikely event that the EndoFLIP System stops normal operation during a procedure use the back panel on off switch to turn the unit off remove the syringe from the unit and retract the syringe plunger manually to withdraw any remaining fluid from the balloon catheter The catheter can then be carefully removed from the patient 2 3 Disconnecting the catheter Once the procedure is complete and the balloon is deflated as described in the EndoFLIP System user manual disconnect the catheter and syringe from the unit and check the structural integrity of the catheter Warning Single use device follow all applicable Federal and local regulations for disposal or rec
4. em is contraindicated where endoscopy is contraindicated e Do not use the EndoFLIP System on patients with actively bleeding varices in the esophagus e The EF 322 catheter is not suitable for diameter measurements less than 5 mm 1 4 Warnings e Do not reuse reprocess or re sterilize Reuse reprocessing or re sterilization can compromise the structural integrity of the device impair performance accuracy due to residual fluid in the balloon and degrade the catheter markings e Federal law U S restricts this catheter to sale by or on the order of a physician e All catheter components are intended for single patient use only do not attempt to reuse Follow all applicable Federal and local regulations for disposal or recycling e To ensure proper operation and to minimize the risk of patient injury do not attempt to add or remove fluid from the supplied pre filled syringes Only use the pre filled syringe supplied with the catheter Note Different catheter part numbers are supplied with different solution concentrations e To avoid damaging the catheter and syringe store away from sources of heat in specified environmental conditions see Appendix A Specifications e Before using the EndoFLIP System and catheter on a patient allow the device to acclimate to conditions of use following transport or storage e During operation check that the amount of fluid in the syringe matches the amount shown onscreen and ve
5. nal Lumen Imaging Probe FLIP that shows dynamic changes in the geometry of the measurement area in a real time image The catheter connects to an EndoFLIP System which injects a conductive solution into the catheter balloon placed in the measurement area The balloon contains an array of electrodes that measure voltage The EndoFLIP System uses these voltages to estimate the diameter at 16 points 1cm apart along the measurement area see Figure 1 Refer to the EndoFLIP user manual for a further description of the system Catheter Tissue Estimated diameter Dest measured at each electrode Balloon inflated with EF 322 16 measurements 1cm apart conductive solution Figure 1 EndoFLIP EF 322 Catheter 4 EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A 1 2 Intended Use The following are the indications of use for the EndoFLIP system and EF 322 catheter In the USA The EndoFLIP System is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity Note The EF 322 catheter is to be used only with the EndoFLIP system Outside the USA The EndoFLIP System is used in a clinical setting to obtain an estimation of the dimensions and balloon pressure within the alimentary canal 1 3 Contraindications e The EndoFLIP Syst
6. pre use checkout tube which holds the balloon in a vertical position see Figure 2 ET Catheter with the balloon inside the Pre use checkout tube Pre use checkout tube ve I Figure 2 EndoFLIP catheter in the pre use check out tube a Prepare the catheter for use as described in the EndoFLIP System user manual EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A 2 2 Placing the catheter Esophageal Diameter measurements Warning Avoid using excessive force during insertion Withdraw the catheter if resistance is too high 1 Wipe down the catheter with an alcohol swab and apply lubrication to the catheter if required 2 Insert the catheter trans orally under endoscopic visualization or trans nasally Insert the catheter until Trans oral the 45 cm mark on the catheter aligns with the patient s teeth Trans nasal the 55 cm mark aligns with the patient s nose If you feel any resistance during insertion retract the catheter slightly then carefully retry Note The markings on the catheter are referenced from the center of balloon 3 Touch PRESSURE ZERO if desired then Inflate the balloon to 30 ml Adjust the balloon position as required to place the image of the GEJ near the bottom Dest on the EndoFLIP screen Note To enable distensibility and compliance displays the balloon must contain at least 10ml and the balloon pressure must be at least 5 mmHg with the Dmin positioned on th
7. rify that the syringe refills as indicated when the plunger aligns EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A 5 with the arrow on the syringe indicating that the balloon is empty before carefully removing the catheter from the patient Verify that there are no leaks in the catheter during the pre use purge cycle described in the EndoFLIP System user manual Replace the catheter if a Dest value remains consistently at a maximum or minimum compared to adjacent Dest values this can indicate a faulty catheter Remove the catheter if the patient requires defibrillation For optimal pressure measurements do not expose the balloon portion of the catheter to excessive light during the procedure Refer to the EndoFLIP user manual for warnings relating to use of the EndoFLIP System Using the catheter This section describes how to install and use the EndoFLIP EF 322 Catheter Installing the catheter assembly Warning Before use inspect the catheter assembly from end to end for breakage occlusions or debris For single use devices do not use if damage to the parts or packaging is evident or if any portion of the package has been previously opened Do not use any part after its expiration date or if the expiry date cannot be verified Remove the catheter assembly from its packaging remove the protective sheath from the balloon and dispose of the sheath Place the balloon tip first into the EndoFLIP
8. ycling of the syringe and catheter 8 EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A Appendix A Specifications Operating and Operating conditions storage conditions Humidity 15 to 95 relative humidity non condensing Atmospheric pressure 700 to 1060 hPa Storage conditions Humidity 10 to 95 relative humidity non condensing Atmospheric pressure 500 to 1060 hPa Main label symbols Single use device Storage temperature limits Use by date Se or EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A 9 Catheter Specifications Maximum Inflate Volume Maximum Inflate Rate Dest Measurement Range Dest Measurement Accuracy Balloon Pressure Measurement Range Balloon Pressure Accuracy Batch code Caution consult accompanying documents Date of Manufacture Caution Federal law restricts this device to sale by or on the order of a physician Box contains quantity n catheters 72ml 60ml min 5mm 22mm 1mm over measurement range OmmHg to 150mmHg 1mmHg over measurement range 10 EndoFLIP EF 322 Catheter Instructions for Use DD 700 Rev A Settable Balloon 10mmHg to 150mmHg Pressure Alarm Limit Manufacturer Crospon Ltd information Galway Business Park Dangan Galway lreland Europe Phone 353 91 519880 Fax 353 91 519889 email info crospon com US Phone 1 855 CROSPON Fax 760 406 5644 email info crospon com En
Download Pdf Manuals
Related Search