EndoFLIP® EF-825 Catheter Models: EF-825 BF
Contents
1. 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 pre use checkout tube which holds the balloon in a vertical position see figure 2 Catheter with the balloon inside the Pre use checkout tube E Pre use checkout tube p gt EEA a Figure 2 EndoFLIP catheter in the pre use check out tube Prepare the catheter for use as described in the EndoFLIP System user manual EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A 5 2 2 Placing the catheter Gastroesophageal Junction GEJ 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 or trans nasally For trans oral insertion use a laryngeal blade if needed to aid insertion 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 patient s physiology e g a hiatal hernia may requ2. resistance As you retract the catheter you should see the stoma moving from the top of the image toward the middle of the balloon center of the screen If not inflate the balloon to 40 ml Retract the catheter until the stoma is positioned at the center of the screen EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A 7 Ifthe diameter at the band position reads 5mm or less inflate the balloon to 40 ml 8 Add or remove fluid to from the band until the intended stoma diameter is achieved 9 Deflate the balloon fully as indicated when the plunger aligns with the arrow on the syringe See Fig 5 and carefully remove the catheter from the patient Cautions e Any gastric band adjustments should be carried out solely in accordance with that gastric band manufacturer s instructions for use e The relationship between band stoma diameter and weight loss has not yet been clinically established Notes e The markings on the catheter are referenced from the center of balloon Syringe returned to original position plunger aligns with arrow P lt N D M Figure 5 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
3. the catheter should be inserted before the band is closed 3 With no fluid fill in the gastric band insert the catheter trans orally and position the balloon centrally within the gastric band If using fluoroscopic guidance the measurement electrodes are clearly visible see Figure 4 EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A 7 Catheter assembly Catheter balloon a Catheter markings are referenced J F from center W of balloon 0 center as e Gastric Catheter band balloon Figure 4 Balloon placement within the gastric band If the gastric band position is known from endoscopy use the catheter markings to guide balloon placement Alternatively you can insert the catheter trans nasally For trans oral insertion use a laryngeal blade if needed to aid insertion 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 patient s physiology e g a hiatal hernia may require the anatomy to be mobilized and straightened before advancing the catheter into the stomach Once the banding procedure is complete inject 2 cc 2 ml into the band and inflate the EndoFLIP balloon to 30 ml Referencing the EndoFLIP screen slowly retract the catheter until you feel
4. 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 4 EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A During operation check that the amount of fluid in the syringe matches the amount shown onscreen and verify that the syringe refills as indicated when the plunger aligns 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 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 825 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
5. 25 Catheter is designed for use with the EndoFLIP System which displays estimates of the diameters at 8 points over a 40mm measurement length along the balloon Throughout this document the EF 825 will also describe the use of the BF 325 unless the BF 325 is specifically referenced 1 1 How it works The EF 825 Catheter acts as a functional 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 5 mm 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 EF 825 16 measurements 5mm apart BF 325 8 measurements 5mm apart Balloon inflated with conductive solution Figure 1 EndoFLIP EF 825 and BF 325 Catheter EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A 3 1 2 Intended Use The following are the indications of use for the EndoFLIP system and EF 825 catheter In the USA The EndoFLIP System is indicated for use in a clinical setting as a dimension measurement device and as an adjunct to other methods in the comprehe
6. CROSPON EndoFLIP EF 825 Catheter Models EF 825 BF 325 Instructions for Use Table of contents 1 MEG CUNO ice ceest otct cea eeiec dean de AAA 3 EN OW IUAWOEN Stes sas inca riun E 3 t2 MCC HOCOW SCs cetean seers et radeeeschateenenecsersdcceecanadeveeahe rae enccaen cis 4 T3 COMUPAWACICAUOINS cite vcterrobs Sede ectece cent econ testis ee tiasveecteeni aa 4 EA Warne S cesarea a ects A N 4 2 Using the cathetebnaire a a AA 5 2 1 Installing the catheter assembly ccccccssssecccceseeceeeeeeeeesaeeeees 5 2 2 Placing the catheter Gastroesophageal Junction GEJ 6 2 3 Placing the catheter Gastric Band adjustMent c cccceseeees 7 2 4 Disconnecting the catheter ccccccccssssccccsseceecseeccesaeeceesaeenees 9 Appendix A SDECITIICATIONS ni Sidicetit tn Sic i eee 10 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 ii EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A 1 Introduction The EndoFLIP EF 825 Catheter is designed for use with the EndoFLIP System which displays estimates of the diameters at 16 points over an 80mm measurement length along the balloon The EndoFLIP BF 3
7. carefully removed from the patient 2 4 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 recycling of the syringe and catheter EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A 9 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 8 a 10 EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A Batch code Caution consult accompanying documents CE Mark and Notified Body Number product complies with requirements of the Medical Device Directive 93 42 EEC Date of Manufacture Rx ONLY Caution Federal law restricts this device to sale by or on the order of a physician Box contains quantity n xn catheters 50ml Catheter Specifications Maximum Inflate Volume Maximum Inflate Rate Dest Measurement Range Dest Measurement Accuracy 60ml min 5mm 25mm 1mm over m
8. easurement range EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A 11 Manufacturer information 12 Crospon Ltd 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 EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A
9. ire the anatomy to be mobilized and straightened before advancing the catheter into the stomach 3 Inflate the balloon to 30 ml Slowly retract the catheter to position the GEJ toward the middle of the balloon center of the EndoFLIP screen 5 To assist in positioning the catheter in low light environments apply tape to the catheter shaft to indicate the distance from the patient s teeth to the GEJ 6 Adjust the balloon position as required to center the image of the GEJ at the balloon 7 When the procedure is finished deflate the balloon fully as indicated when the plunger aligns with the arrow on the syringe See Fig 5 and carefully remove the catheter from the patient 6 EndoFLIP EF 825 Catheter Instructions for Use DD 646 Rev A Catheter assembly H Catheter balloon Catheter markings are referenced I from center Catheter of balloon balloon 0 center of GEJ balloon i Figure 3 Balloon placement in the measurement area e g GEJ Note The markings on the catheter are referenced from the center of the balloon 2 3 Placing the catheter Gastric Band adjustment 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 Ifthe procedure includes a hiatal hernia repair the catheter should be inserted before the repair otherwise
10. nsive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity It is also indicated for use to estimate the size of a stoma produced by a gastric band Note The EF 825 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 within the alimentary canal 1 3 Contraindications e The EndoFLIP System 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 825 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 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
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