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Transducers and Consumables

1. s instruction Mounting the WBSL Needle Guide on LA Probes The WBSL adaptors for LA biopsy probes are composed of two parts the coupling device to be connected to the probe and the needle guide Make sure that the probe has been disinfected Apply ultrasound examination gel to the probe or to the tip of the protection cap Cover the probe with the protective cap securing it with the rubber band provided The protective sheaths available on the market often contain latex Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such a reaction If the protective cover is damaged during the exam on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int Connect the coupling device to the probe by placing its grooved side on the probe s ridge Close the coupling device by hitching it to the opposite side of the probe 2 Civco Medical Instruments Kalona IOWA www civcomedical com 7 5 MyLab TRANSDUCERS AND CONSUMABLES Notes The guiding device for needle insertion must be on the same probe side of the LED The coupling device must click into the special notch on the probe a
2. 1 Gare of Transducers Damage caused by Handling Transducers dropping or knocking a probe against other Incorrect handling can seriously damage any transducer Both the acoustic lens and objects stepping on or the crystal elements can be damaged if the transducer is dropped or struck against twisting a cable or a cable becoming entangled are not covered by the There are several ways a probe can be damaged for example guarantee another object Cuts on the probe cable or breakage of the housing may jeopardize the electrical safety of the transducer e Dropping or knocking against another object Contact with sharp edged objects Contact with chemical agents Contact with hot surfaces e Immersion in liquid substances e Exposure to high voltage discharge Exposure to environmental conditions out of allowed range WARNINGS Do not use a probe if any of the above listed events occur until it has been established if any electrical damage to the probe has occurred by measuring the current leakage see Appendix C for further details Contact the Esaote Service Representative Do not tug the probe cable or bend it If the probes are carried around on a trolley make sure that the wheels do not roll over the cable Periodic Probe Control Schedule The following tables describe the periodic control that must be made on the probes The frequency suggested for non invasive probes is considered to be the minimum very f
3. 1 30 coupling 5 needle guides 1 25 coupling 1 35 coupling 5 needle guides 1 36 3 coupling 1 coupling 45 angle 5 needle guides 1 coupling 45 angle 5 needle guides 1 35 coupling 1 coupling 2 8 angle 1 needle guide 1 coupling 45 angle 5 needle guides See Appendix A in this manual for probes characteristics The ABS kits for LA CA and Intraoperative probes include 14 18 20 21 and 22 gauge needles the ABS kit for the endocavity probe has a guide for a 16 gauge needle the ABS kit for the transrectal probe includes 14 16 18 and 20 gauge needles G12 and G19 needle guides are available for the CA LA and intraoperative probe ABS kit Do not use needle guides other than those described in this manual ABS421 ABS424 ABS1421 Type T ABS523 ABS621 ABS15 and WBSL33X kits are composed of stainless steel the ABS123 needle guide kits is composed of titantum 7 1 Disposable needle guides for CA and LA probes MyLab TRANSDUCERS AND CONSUMABLES In addition to the above mentioned biopsy adaptors the CA and LA probes are equipped with biopsy kits composed of sterilizable mounting brackets and disposable needle guides The following table lists the available kits Biopsy Manufacturer s Probe Kit contents adaptor kit code DBS421 431 1992 CA421 1 20 coupling 1 30 coupling set of needle CA430 guides CA431 DBS621 631 7354 CA621 1 25 coupling 1 35 coupling set of needle
4. 7 2 Dupin the I xdmiidt lOi ue uoo ricette Renee eie eius ee Rene O r esL eiiim 7 3 A tie Endor tie ExamiiattOfi ooa btc Medea et idoli bump Dites tunitet iesus Pacte led 7 3 Mounting the ABS Needle Guide for LA and CA Probes sss 7 3 Disposable Biopsy Rat Tor C A T4221 Probe uo eS EO PUER Hp n aede e es 7 5 Mounting the WBSL Needle Guide on LA Probes cesses 7 5 Mounting the Needle Guide for CAB411A Probes eseeesseeeeeeeeeeeneneneeeeeennnennnnn nnns 7 7 Mounting the ABS Needle Guide on the EC123 Endocavity Probe eeeeeeeseee 7 8 ES RIOP Endocavity Prom a oseecsdeue tectis tha am FR eoi eu etui era mte edidit semis 7 10 EC TE2S EBndocavity PIODE as ere I ERE epe etn etu 7 10 Mounting the ABS Trans rectal Probe Needle Guide sss 7 11 Mounting the ABS Intraoperative Probe Needle Guide eesssssseeeeeeeeeeeeeneel 7 12 FAG ASS NOLIN OG oh te opts tete mta demittit teret etas Seana fast ese ties 7 13 58 ACCESSOFIeS and Consuniabl s sseb ae aaaea aaga derase 8 1 ECOC IDI e A ee ee O A 8 1 Checking the oh OC able rr a E EE 8 1 Cleanime and Disintectime Me ECO Cables N a N N 8 Stand On Tor Linear PEODSS eias oom Rh REI DE D a a ure uds ia eI Put e vU M IUDAS 8 2 c 8 3 Oel lS RE E T u ac Dra aed IP re ere 8 4 Accessory Kits for Tr
5. ABS123 ABS424 ABS523 ABS1421 Type T ABS 421 ABS621 and WBSL33X kits MyLab TRANSDUCERS AND CONSUMABLES Manufacturers of Recommended Agents FDA A a Countty of Presentation Main ingredients Manufacturer Approved manufacture No lutaraldehyde No Liquid Alkalyne glutaraldehyde solution Advanced Sterilization Products Yes rtho phtalaldehyde USA www stetrad com about asp locations index asp No lutaraldehyde No No No Low temperature hydrogen System peroxide gas plasma No thylene Oxide es lutaraldehyde OTTRELL LTD zi Liquid Buccindildehyde e ftir GmbH No liga buan daldensde www schuelkemayt com int en contact smi044 adresses htm No n aqueous solution hydrogen Powder D eroxide and peracetic acid UK ELSE wet d ee ex co uk lab_products as No Liquid otassium peroximonosulphate cre xi E No Wipes 14 3 IPA etrex Research Corporation No Liquid Jes Peroxide and peracetic USA www mettex com company contact index cfm Yes lutaraldehyde Yes lutaraldehyde ave Energy Systems INC Yes pom cidt lowtemperature biocidal ag A No jars Hydrogen peroxide phosphoric Us Liquid cid No Liquid nzymatic detergent No n aqueous solution hydrogen owder T i ete Italy Euro Trading S r l peroxide peracetic acid No System Steam Various arious manufacturers No olyhexanide quaternary owder j ammonium chloride No Liquid lutaraldehyde No Quaternary ammonium propionate s owder NEU pron gt
6. gloves protective glasses The probe eventual accessories and the kit must be sterilized before it is used for the first time They must be cleaned and sterilized after every examination e Dismantle the kit or the accessories from the probe Clean the kit the accessoties or the probe carefully with mild soap e Follow the instructions of the manufacturer of the sterilization agent Note The material used for needle guide kits can undergo all the sterilization methods used for surgical instruments The type of tissue the transducer comes into contact with establishes the disinfection level MyLab TRANSDUCERS AND CONSUMABLES For information on how to store sterilized parts refer to the locally applicable procedures Cleaning and Sterilizing the Biopsy Attachment of CAB411A Probe Wearing gloves is recommended during cleaning and sterilization operations Clean the attachment with a mild soap solution make sure that no residuals are left Sterilization Place the attachment in an appropriate bag and use Ethylene Oxide Gas at Procedure following conditions e Temperature below 55 C Gas pressurization 1 2 kg cm Gas depressurization 760 60 Torr Aeration below 55 C Note Regard any exam waste Le protective cover etc as potentially infectious material and dispose of it accordingly 2 6 MyLab TRANSDUCERS AND CONSUMABLES Chapter 3 The Transesophageal Probes The t
7. least 30 minutes Cleaning and Disinfecting Probes Used in Semi Critical Applications The procedures described in this paragraph apply to all probes used in semi critical applications The application is considered semi critical when the device is used on the mucous membranes The use of sterile sheaths for this type of application 1s recommended and high level disinfection is necessary Wearing gloves is recommended during probe cleaning and disinfecting operations The probe must be disinfected before it is used for the first time The probe must be cleaned and disinfected after every examination e Disconnect the probe from the system e Remove the protective sheath clean the probe handle the transducer and the endoscope with the recommended agent Note Handle any examination waste protective sheath gloves as if potentially infected and treat it accordingly If the probe is contaminated by body fluids disinfect it before and after cleaning Immerse the probe casing into the recommended agents following the manufacturer s instructions very carefully Do not leave the probe immersed in the disinfectant for longer than the time indicated by the manufacturer for high level disinfection TS CAUTION Please refer to next chapters for more information on the accessories of the intraoperative probe a WARNING Esaote recommends sterilizing the probe and the kit before they are used for the first
8. transducers and biopsy kits depending on their application The risk of infection establishes the type of application Device Non invasive probes Transesophageal and Endocavity probes Intraoperative and Laparoscopic probes Needle Guide kits Application Non criticall Semi ctitical l CriticalPl CriticalPl Operation Cleaning Disinfection Cleaning and Disinfection Cleaning and Sterilization Cleaning and Sterilization Frequency Before the first use and after each exam When necessary Before the first use and after each exam Before the first use and after each exam Before the first use and after each exam 1 The application is considered non critical when the device is used on intact skin 2 The application is considered semi critical when the device is used on the mucous membranes 3 The application is considered critical when the device comes into contact with blood or compromised tissue If non invasive probes are used in semi critical critical applications and in a sterile field apply protective sheaths during the examination These sheaths are usually composed of latex natural rubber Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such reactions ESAOTE recommends disinfecting the probe if the probe has not been used for an exten
9. 7 Needle guides kits The chapter describes the procedures for assembling the kits e Chapter 8 Accessories and Consumables The chapter describes how to check clean and disinfect the ECG cable The chapter also gives information about the characteristics of the consumables e Appendix A MyLab Probes The appendix details available models and their main characteristics e Appendix B Cables Consumables and Agents The appendix details the ECG cables characteristics and recommended ECG disposable electrodes The appendix lists the recommended cleaning disinfection and sterilization agents e Appendix C Probe Electrical Safety The appendix explains how to check the electrical safety of the probes In this manual WARNING identifies a risk for the patient and or the operator The word CAUTION describes the precautions necessary for protecting the equipment Make sure you understand and follow these instructions Table of Contents T CAVE OF TEAnsdUCeEs sioe e E ETa 1 1 Pando T ransducebs usce du nutu e et butt ce eat NU cM ET MEE 1 1 Penodic Probe Control SC BEdUle aneor tentem tet Aen idet oda mites Unido eee 1 1 Transducer Controls aee oto rolls en Saa Sait cuoi Uu LA ums a a RS DM OS LE RUDI qd UE 1 2 Non invasive Transdueefs 3a tet a eE ATE EE tues des 1 2 Irnvastye Dransduee fS aces toit HA Ude nU ebbe P EUM beet ebat hte EE EUIS L Inest epe bent 1 3 Stonne and Protecting the Dransdueetelssue ooo oe tb Hep UHE UE Eee tra bnb d e
10. C C T Spray C C C C G C T Spray II C C C C C C Virkon D D D D D D Wavicide 01 D S D S D S D S D S D S MyLab TRANSDUCERS AND CONSUMABLES Phased Array Probes Accel RTU Anios Detergent Desinfectant Cidex Cidex Activated Dialdehyde Solution Cidex OPA Cidexplus Enzol Cydezime Gigasept 10 vol Gigasept FF Hexanios G R Medi Prep Medister Metticide Milton Omnicide 2 25 PreCept RTU Sani cloth Active Steranios Transeptic T Spray T Spray I Virkon Wavicide 01 PA023 J D S Gt Pi O G ur D S D 0 cO D G O g D S PA121 J D S Cy Wa cU vC doy e T5 D S EJ deste nS oe Sos D S PA122 C C Gig WN OG eeu O O Eb A S J OA ce Cv ve eS D S PA240 Vg cn Cte su O cO ara S z JO O O E O D S PA230 C C Vg cn O yw em IUD S S ooonontonoc g N B 4 MyLab TRANSDUCERS AND CONSUMABLES Specialty Probes BC431 CAB411A E8 5 EC123 EC1123 BE1123 R10P Accel RTU C X C C C C Alkazyme X G C X X X Anios Detergent C C C C C C Desinfectant Anioxyde 1000 X X S X X X Cidex D D D D D D Cidex Activated S X X X S D S Dialdehyde Solution Cidex OPA D D D D D D Cidexplus D S D S D S D S D S D S Compliance X X X D S X X Enzol Cydezime C C C C C C Ethylene Oxide X S X X X X Gigasept 10 vol D D D D D D Gigasept FF D D D D D D Hexanios G R C C C C C C Klenzyme X X C X X
11. Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int The figure shows an example of how the needle guide is assembled on the CAB4114 AABS123 Biopsy kit for the EC123 probe MyLab TRANSDUCERS AND CONSUMABLES Close the bracket by folding in half Insert the bracket into the gap on the scan head paying attention to push it into the special safety catch on the probe Insert the needle guide in one of the three holes formed between the wings of the bracket paying attention to choose the correct insertion angle For disassembly of the biopsy kit reverse the previous procedute Mounting the ABS Needle Guide on the EC123 Endocavity Probe The ABS123 endocavity biopsy kit is composed of two parts the coupling to be connected to the probe and the needle guide device Make sure that the probe has been disinfected Apply ultrasound examination gel to the probe or to the tip of the protection cap Cover the probe with the protective cap securing it with the rubber band provided WARNING MyLab TRANSDUCERS AND CONSUMABLES The protective sheaths available on the market often contain latex Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such a reaction If the protective cover is damaged during the exa
12. Store the probe as indicated in Chapter 1 of this manual Preparation of the Laparoscopic Probe Follow the instructions below for preparing the laparoscopic probe Note The Operator is recommended to wear gloves during the probe preparation procedure e Apply a sufficient quantity of ultrasound gel inside the sheath The protective sheaths available on the market often contain latex Make sute that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such reactions Note Esaote recommends use of sterile sheaths in intraoperative examinations e Completely unroll the sheath along the transducer body making it adhere so as to avoid ait pockets e Secure the sheath with the rubber band provided 6 4 mn AO WARNING MyLab TRANSDUCERS AND CONSUMABLES 7 Needle Guide Kits Chapter See the MyLab Advanced Operations manual for correct use of the needle guide ESAOTE supplies a series of optional adaptors for the biopsy needle guide fitted with special couplings for connection to the probe The following table lists the available kits Biopsy adaptor ABS421 ABS621 Type T ABS1421 ABS523 ABS424 WBSL33X ABS123 ABS15 Probe CA421 CA430 CA431 CA621 CA631 CA1421 LA523 LA522 LA523P LA532 LA424 LA435 LA332 EC123 IOE323 Kit contents 1 20 coupling
13. as it takes to achieve the diagnostic information During the Examination Before probe use check to be sure that the probe name shown on the monitor is correct Esaote tecommends the Operator to Never force the probe during manipulation and extraction if there is any resistance in introducing the probe interrupt the examination Make sure that the tip is straight and released before inserting or removing the probe Insertion manipulation or forced removal can seriously damage the patient s esophagus Do not leave the probe against the esophagus wall for prolonged periods Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro organisms is suspected e If it is necessary to use the defibrillator disconnect and remove the probe from the patient Electric scalpels and other devices that introduce radio frequency or electro magnetic current fields into the patient interfere with ultrasound images 3 3 WARNING WARNING Wao The Advanced Operation manual indicates specific information applicable to your MyLab model How to Minimize Probe Heating MyLab TRANSDUCERS AND CONSUMABLES High frequency signals used by ultrasound can interfere with the functioning of pacemakers Even if the possibility of interference is remote interrupt the examination immediately if interference with a pacemaker is noticed While using the system in combinatio
14. cable further than the start of the leads The cable is not waterproof Rub the cable gently with a soft cloth slightly dampened with a mild detergent solution or alcohol Dry the cable by rubbing it gently with a soft dry cloth The ECG cable can be disinfected using CIDEX OPA following the manufacturet s instructions Disconnect the cable from the system Clean the cable as explained in the previous paragraph Immerse the ECG cable leads in CIDEX OPA When using the disinfectant substance carefully follow the manufacturer s instructions Stand Off for Linear Probes The stand off part number 9650030000 allows to keep some distance between the probe head and the skin thus moving the focus area of the probe The use of a stand off 1s therefore valuable when studying the tissue surface in musculo skeletal and vascular applications The stand off can be mounted on all MyLab linear probes with size 4 e 5 cm LA 4XX and LA5XX probe families CAUTION Using the Stand Off CAUTION Cleaning and Disinfecting CAUTION Sterilizing CAUTION MyLab TRANSDUCERS AND CONSUMABLES To get the desired distance the operator has to fill with water preferably sterile or ultrasound gel the contact pocket equipped with a cock The pocket can be filled and emptied using a syringe which perfectly suits into the cock opening During the exam check that the cock is perfectly closed and correctly m
15. cleaned at regular intervals to ensure that they work properly Esaote recommends removing the gel from the probe between one examination and the other this keeps the probes clean between one complete cleaning procedure and the next Disinfection Procedure WARNING MyLab TRANSDUCERS AND CONSUMABLES Probes Tightness to Liquids Do not immerse the probe cable or connector in water or other liquid The probes can be inserted in water up to the Maximum Immersion Level that will not compromise a probe s integrity Connector immersion in water or other liquid can compromise the safety feature of the probe Damage caused by the probe immersion is not covered under the warranty Cleaning Probes Used in Non Critical Applications The cleaning procedures described in this paragraph apply to all the probes used in non critical applications An application is considered non critical when the device is used on intact skin Disconnect the probe from the unit e Remove all residues of ultrasound gel from the probe using a soft cloth Clean the probe by rubbing it lightly with a soft cloth soaked in a solution of water and mild soap e Rub the probe with a soft damp cloth to remove any soap residue Dry the probe by rubbing it with a soft dry cloth Disinfecting Probes Used in Non Critical The disinfection procedures described in this paragraph apply to all probes used in non critical applications The application
16. is considered non critical when the device is used on intact skin Low level disinfection is sufficient for these applications The probes can be disinfected using the recommended agents following the manufactuter s instructions Disconnect the probe from the system Clean the probe as described in the previous paragraph Immerse the probe casing in the recommended agent following the manufacturer s instructions very carefully Do not immerse the entire body of the probe The probe is not waterproof and immersion may compromise the electrical safety characteristics see Appendix A for Maximum Immersion Level a ET CAUTION Esaote recommends disinfecting the probe before it 1s used for the first time after prolonged storage periods WARNING MyLab TRANSDUCERS AND CONSUMABLES Do not soak the probe in the disinfection solution for periods beyond the time required to achieve a disinfection Do not try to sterilize probes using the autoclave ultra violet rays gamma tays or gas steam or heat sterilization techniques These sterilization methods can permanently damage the probe Any damage to the probe caused by substances or methods not approved by ESAOTE is not covered by the guarantee Extract the probe rinse it with sterile water and clean the probe handle and cable using the recommended agents or with a mild detergent solution Dry the probe carefully using a soft cloth or leave it to air dry for at
17. nidi eto hede ebrius 1 7 Daily Storage and Prove COM cet ons dete ere RE cto E Pt AT ETA 1 7 Storing and Protecting the Intraoperative and Laparoscopic Probe ussssss 1 7 Transport or Long Term Storage and Protection sess 1 7 Disp tchine th Trans CUCL soutien iens oe ete ERR ambe etat i pee e aun EEE 1 8 INeedle Guide Kat CoOntfol see ou END pd WEIN iM NE MEL E LM 1 8 Storing and Protecting Needle Guide Kits iiie p a a da aie PE RR EE FR a D 1 8 2 Cleaning and Disinfecting Transducers and Biopsy Kits eeeeeeeeeees 2 1 Periodic Cleaning and Disinfecting Schedule eseeessssssssssseseeeseeeeeennnnnnns 2 PMNS ocn tan ME Meu Dti eM De tiat sedet 2 2 Probes Iiehtiess to EIqUIOSC 4 ot bete dud Exe due re So E PC e RE 2 2 Cleaning Probes Used in Non Critical Applications sess 2 3 Disinfecting Probes Used in Non Critical Applications eeeeeessssssssssseeeeeeeeeeenennns 2 3 Cleaning and Disinfecting Probes Used in Semi Critical Applications 2 4 Cleaning and Sterilization of Intraoperative Laparoscopic probes and Needle Guide Kits 2 5 Cleaning and Sterilizing the Biopsy Attachment of CAB411A Probe sssss 2 6 3 The Transesophageal Probe uei oio toe vae eo eese eoe Eae eo ction NE 3 1 Characteristics and Compobelllssaii oe
18. probe preparation procedure Apply enough ultrasound gel inside the sheath The protective sheaths available on the market often contain latex Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such reactions Note Esaote recommends use of sterile sheaths in intraoperative examinations 5 4 TRANSDUCERS AND CONSUMABLES MyLab Completely unroll the sheath along the transducer body making it adhere e so as to avoid ait pockets Secure the sheath with the rubber band provided Handle Attachment The handle attachment is inclined 30 degrees and can be placed on the probe in four different positions to form four different shapes profiles A B C and D as shown below and on the following pages y F uM 5 eae Ve HiFi y IL Probe s Holder Ado yl ie i af a UT E al j og f I Pa Li iL F y y T A ff r Cs dad F ef f cw il y N 30 inclination til lli j TE Hi I i Hy I Ir lii J Whe 5 5 MyLab TRANSDUCERS AND CONSUMABLES Probe s Transducer Probe s Transducer Probe s Transducer Finger Attachment The Finger Attachment allows manipulation of the Intraoperative IOE323 probe for use with only two fingers The 4 facets at 90 degrees allow the user to obtain four different insertion methods wit
19. suspected that it has been damaged contact ESAOTE immediately Do not attempt to dismantle the probe any attempt to dismantle the probe may result in damage to the probe and will void the warranty and could compromise its safety WARNING CAUTION MyLab TRANSDUCERS AND CONSUMABLES In order to minimize the probability of damaging the probe the following operations ate suggested e Do not touch the lens at the front of the probe Never exert force on the lens The connector is not waterproof and should always be kept dry After use clean and disinfect the probe as specified in this manual Control of the Intraoperative Probe The Intraoperative probe must be carefully inspected before every examination Perform a manual and visual check to ensure that there are no holes bulges tears ot dents along the entire surface of the probe Check the cable manually and visually there must be no cuts or irregularities The connector pins are not bent If the pins are damaged do not use the probe and have it repaired When not in use store the probe as specified in the next paragraph Breaks in the probe casing or in the cable could expose the patient and or the operator to an electrical safety risk Do not use a probe if it has been dropped A leakage current test see Appendix C for further details must be performed prior to re use to ensure that no electrical damage to the probe has occurred Physic
20. BLES IOE323 Probe The IOE323 intraoperative probe uses the Esaote sterilized sheath Ref 1000000065 LP323 Probe The Laparoscopic probe uses the Esaote sterilized sheath Ref 7900000210 Accessory Kits for Transesophageal Probes The kits listed below ate produced by CIVCO Medical Instruments Inc Kalona IA USA Refer to the manufacturer s instructions for the characteristics and use of the kits TEEO22 Probe Manufacturer s code Content Sterile Latex 610 840 Bite guard and sheath No No with application kit MyLab TRANSDUCERS AND CONSUMABLES es Probes Denomination MyLab TRANSDUCERS AND CONSUMABLES Appendix Appendix A MyLab Probes This chapter provides a list of MyLab probes with their main characteristics system dependent features are described in your model documentation The name of ESAOTE probes includes e a prefix indicating the technology used ex PA Phased Array CA convex transducer etc e a number indicating the transducer type e when applicable a letter indicating the production site The user manual and the display always identifies the probe by using the prefix and the number only Phased Array Probes Probe ID Maximum immersion level PA240 Up to 3 cm from transducer head PA230 Up to 3 cm from transducer head PA121 Up to 3 cm from transducer head PA122 Up to 3 cm from transducer head PAO23 Up to 3 cm from transducer head Linear Probes Probe ID Maximum immersion l
21. CA631 guides DBSC12X 7356 C A123 1 coupling 15 angle set of needle guides DBS523 7351 LA523 1 coupling 45 angle 1 coupling 60 angle 1 1522 coupling 75 angle set of needle guides LA532 DBS424 435 7350 LA424 1 coupling 45 angle set of needle guides LA435 The following needle guides are sterilized single use kits Biopsy adaptor Probe Kit contents Type X EC123 25 disposable biopsy kits 3 8 angle EC1123 Type O E8 5 R10P 25 disposable biopsy kits 3 angle Each kit contains sterile probe cover sterile needle guides sterile gel and sterile elastic bands plus non sterile mounting bracket and non sterile verification kit The sterile needle guides are of different colour to match the needle to be used The needle guides are sterile but cannot be re sterilized The biopsy adaptors must be attached to the probes using the alignment pivots as below described Follow the instructions provided by the Manufacturer with these kits to properly use them and to clean disinfect and sterilize them Examination Safety All safety information related to the use of the needle guide kits is in addition to the safety procedures described for the system and for the probes Consult your MyLab Safety amp Standard manual for additional safety information Before the Examination Before each examination Esaote recommends that the Operator e Handle the biopsy kit and the probe with sterile gloves Manufacture
22. ESAOTE Rev J September 2011 TRANSDUCERS AND CONSUMABLES OPERATOR MANUAL 29B04ENIO Introduction This manual provides information about the probes and consumables that can be used with the Esaote MyLab devices The manual is divided into the following chapters e Chapter 1 Care of transducers The chapter describes how to handle control store and protect ESAOTE tranducers e Chapter 2 Cleaning and disinfecting the transducers The chapter describes how to clean and disinfect non invasive transducers and those used in semi critical applications e Chapter 3 Examinations with transesophageal probes The chapter lists the specific safety requirements for examinations with trans esophageal probes A description is also given on how to prepare the probe for the examination e Chapter 4 Examinations with the endocavity probe The chapter lists the specific safety requirements for examinations with the endo cavity probe A description 1s also given on how to prepare the probe for the examination e Chapter 5 The Intraoperative probe The chapter lists the specific safety requirements for examinations with the intraoperative probe A description is also given on how to prepare the probe for the examination e Chapter 6 The Laparoscopic probe The chapter lists the specific safety requirements for examinations with the laparoscopic probe A description is also given on how to prepare the probe for the examination e Chapter
23. France Laboratoires Anios www anios com guanidinium acetate Agent Cidex Cidex Activated Dialdehyde Solution Cidex OPA Cidexplus Enzol Cydezime NuCidex STERRAD 100 Ethylene Oxide Omnicide 2 25 Gigasept 10 vol Gigasept FF lt Perasafe Virkon Cavi Wipes Compliance Metricide Wavicide 01 Steris Rasa HED Seu STERIS Corporation www steris com HLD Klenzyme Medister Steam autoclave Hexanios G R Steranios Salvanios Anioxyde 1000 Anios Detergent Desinfectant Z No Liquid eracetic acid No Liquid Quaternary ammonium propionate q guanidinium acetate No Quaternary ammonium compound imonoethanolamine Professional Disposables International No ipes Quaternary ammonium compound USA mo www nicepak com divisions pdi default asp Isopropyl alcohol No Quaternary ammonium compounds No Wipes 1 cetrimide BP No Liquid Sodium h koit Fran Milton Pharmaceutical Ltd www milton tm com milton baby E acce UCM T hyciene products contact htm or Laboratoires RIVADIS NO powder feeder ammosUM o Pune Mlkapharm UK Ltd evvallapharm coak Yes Liquid ydragen H toside y De Healthcare Inc www sultanhealthcare com Transeptic Yes sopropyl alchol USA Parker Laboratories Inc www parkerlabs com Topay No pray Ps cu UNE EE USA Pharmaceutical Innovations Inc www pharminnovations com TSpsyTi hloride Accel RTU ydrogen peroxid
24. If the user does not perform this operation correctly the insertion angle can be wrong causing a risk to patient safety To disassemble the biopsy kit reverse the previous procedure WARNING MyLab TRANSDUCERS AND CONSUMABLES Mounting the Needle Guide for CAB417A Probes CAB411A is a special probe designed for biopsy The bracket for CAB411A biopsy probe consists of only one plastic part with three different insertion angles 0 15 and 30 degrees Each bracket has imprinted the dimension of supported needles 14 16 17 19 20 and 23 gauge needles Needles dimension The innovative design allows easy removal of the biopsy attachment while the needle is inserted in the tissue Note Brackets supplied by ESAOTE are neither disinfected nor sterilized Make sure that the probe has been disinfected Apply ultrasound examination gel to the probe or to the tip of the protection cap Cover the probe with the protective cap secure with the rubber band provided The protective sheaths available on the market often contain latex Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such a reaction If the protective cover is damaged during the exam on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the
25. K x D S cop edt ae pers pA vA pA P OKO K C cv cc c D S CA430 X X C OK X D S She acp dp gd KKK KOKO x Lj Oh Su Sy uM D S CA541 C PA UPS M O NOAA AO M pS we S TAO OO v uq IO SX ou M Io od CX 94 d LJ D yo cO ps CA431 C X X C OK X mS en pd oC wx wet c GU uw U cy 4 S pA vA KK OKO RK OC CD e sd D S CA621 O0 0 OK X D S g VN Dp Auu OD Cy Mu D S c Up qu rte oM OWN CM TE D S CA631 C X X C OK X T N KOK KK KOK KK OK KK KO OK mx o J oOo A O g B 2 MyLab TRANSDUCERS AND CONSUMABLES Linear Probes LA332 LA424 LA435 LA522 LA523 LA532 Accel RTU C C C C C C Alkazyme X X X X X X Anioxyde 1000 X X X X X X Anios Detergent C C C C C C Desinfectant Cidex D D D D D D Cidex Activated S S S 5 5 5 Dialdehyde Solution Cidex OPA D D D D D D Cidexplus D S D S D S D S D S D S Compliance X X X X X X Enzol Cydezime C C C C G C Gigasept 10 vol D D D D D D Gigasept FF D D D D D D Hexanios G R C C C C C C Klenzyme X X X X X X Medi Prep C C C C C C Medister S S S S 5 5 Metricide S S S S S S Milton C C C C C C NuCidex X X X X X X Omnicide 2 25 D S D S D S D S D S D S Perasafe S X X X X X PerCept RTU C C C C C C Salvanios X X X X X X Sani Cloth Active C C C C C C Sani Cloth HB X X X X X X Resert HLD ex Secure X X X X X X HLD Steranios D D D D D D Transeptic C C C C
26. X Medi Prep C X C C C C Medister S S X S S X Mettricide S S S S S S Milton X C X C X X NuCidex X X S X X X Omnicide 2 25 D S X D S D D S D S Perasafe X X S S S X PreCept RTU C X C C C Salvanios X C C X X X Sani cloth Active C X C C C C Resert HLD ex Secure X X D S D S X X HLD Steranios D D D D D D STERRAD 100 X S X X X X Transeptic C G G C G T Spray C C C C C C T Spray II C C C C C C Virkon amp D X D D D D g CE N Wavicide 01 D S D S D S D S D S MyLab Accel RTU Alkazyme Anioxyde 1000 Anios Detergent Desinfectant Cidex Cidex Activated Dialdehyde Solution Cidex OPA Cidexplus Compliance Enzol Cydezime Ethylene Oxide Gigasept 10 vol Gigasept FF Hexanios G R Klenzyme Medi Prep Medister Metricide Milton NuCidex Omnicide 2 25 Perasafe PreCept RTU Salvanios Sani cloth Active Resert HLD ex Secure HLD Steranios STERRAD 100 Transeptic Spray T Spray T Spray II Virkon Wavicide 01 IOE323 x TOO KK x g CO O m MH OAKM KX MOO eM DO rmZO wR KOO D S FODAAK wD LP323 x OO K x oO OQ Or NDRKHAK KHRAQTAK DGDCHRA K K GD D S CDAAK AD TRANSDUCERS AND CONSUMABLES TEE022 TEE122 TEE132 X X X X x Oo oe p E ome Ra BoBcm E ac dcl Sos La ac TRTI33 CX CU DE D S g T VN tu wy uw pcsd vc SO x oxowZ Nn D S LJ uon DES g D S MyLab TRANSDUCERS AND CONSUMABLES Doppl
27. al damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if it is known or suspected that it has been damaged contact ESAOTE immediately Do not tty to dismantle the probe any attempt to dismantle the probe may damage it and will void the warranty In order to minimize the probability of damaging the probe the following operations ate suggested e Do not touch the lens at the front of the probe Never exert force on the lens The connector is not waterproof and should always be kept dry When not in use store the probe in its case After use clean and sterilize the probe as specified in this manual 1 5 WARNING CAUTION MyLab TRANSDUCERS AND CONSUMABLES Control of the Laparoscopic Probe The laparocopic probe must be carefully inspected before every examination Perform a manual and visual check to ensure that there are no holes bulges tears ot dents along the entire surface of the probe Perform a manual and visual check of the endoscope while bending the tip in all possible directions deflection must function according to characteristics and the guides must not protrude during these movements Check the cable manually and visually there must be no cuts or irregularities The connector pins are not bent If the pins ar
28. al notches on the probe Notes The guiding device for needle insertion must be on the same probe side of the LED The coupling must click into the special notch on the probe When using the disposable biopsy adaptors and with the ABS1421 the coupling device has to be mounted before inserting the protective cap this will allow to safely use the same coupling device in different exams n Needle Fixing screw for the needle guide 1 Fixing screw for the coupling device Make sure the bottom cone shaped part at the bottom of the bracket is screwed into the indentation at the bottom of the top curved portion of the 7 4 WARNING MyLab TRANSDUCERS AND CONSUMABLES probe If the user does not perform this operation correctly the insertion angle can be wrong causing a risk to patient safety For disassembly of the biopsy kit reverse the previous procedure Disposable Biopsy Kit for CA1421 Probe The CA1421 probe is available with a disposable biopsy kit with 36 3 coupling angle The kit includes a guide for 14 16 18 20 22 and 25 gauge needles The kit can be ordered from CIVCO Manufacturer Manufacturer s Contents kit code CIVCO Medical Instruments 610 137 Disposable sterile kit with needle guides Inc Kalona IA USA 8x45cm sheath seal and gel The plastic disposable guide is sterile but cannot be re sterilized For a correct use of the disposable biopsy kit please refer to the manufacturer
29. and make it impossible to use Doppler procedures WARNING See Chapter 8 on consumables for selecting the gel and sheathes WARNING MyLab TRANSDUCERS AND CONSUMABLES Electric scalpels and other devices that introduce radio frequency or electro magnetic current fields into the patient interfere with ultrasound images While using the system in combination with high frequency devices like electro surgical units be aware that a failure in the surgical device or a damage to the transducer lens can cause electro surgical currents that can burn the patient Thoroughly check the system and the probe before applying HF surgical currents to the patient Disconnect the probe when not imaging Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically Perform a manual and visual check before each examination to ensure that the probe is intact At the End of the Examination At the end of the examination Esaote recommends that the Operatot e Clean and sterilize the probe according to the instructions provided in Chapter 2 of this manual e Store the probe as indicated in Chapter 1 of this manual Using the IOE323 Intraoperative Probe Follow the instructions given above to prepare the intraoperative probe Note The operator is recommended to wear gloves during the
30. angle involves risks to patient safety At the End of the Examination At the end of the examination Esaote recommends that the Operator clean and sterilize the kit clean and disinfect the probe used during the biopsy Mounting the ABS Needle Guide for LA and CA Probes The ABS adaptors for LA and CA biopsy probes are composed of two parts the coupling to be connected to the relative probe and the needle guide device e Make sure that the probe has been disinfected Apply ultrasound examination gel to the probe or to the tip of the protection cap WARNING The following figures show an example of how the ABS523 is assembled on the LA323 WARNING MyLab TRANSDUCERS AND CONSUMABLES Cover the probe with the protective cap securing it with the rubber band provided The protective sheaths available on the market often contain latex Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such a reaction If the protective cover is damaged during the exam on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int Connect the kit to the probe positioning the two alignment pins on the speci
31. ansesophageal Probes ccccccccecccceccceecesaeeeeessssessseeeeeeeececeeeeeesaaaaaas 8 5 Appendix A MyLab PErOD6S nine DEED Dti ioo eee eee A 1 Phased Atay PHOS isaac edm c ned oet Drake Ub ome er uae wb dha dese oon Duke e doe imi eine A Linear PrODOS costera u ta umo a tud M MM Ce PI M UAM A 1 Conyex PEODES d hae e E E E E hha ee ccees A 2 Specialty Probe Scenerne r r r a e oere e A 2 Doppler a 00 0 21s ner beta de eon ete erbe e E E A A 3 Appendix B Cables and Consumables ssssseccccoossssssccccoccsssescecocsossssscecesossssssceesosssssssseessso B 1 ECO CDI E B 1 Recommended C OMG UI MAIC S eei stephen Edebidni bonae hri EP UE Magee eons B 1 Cleaning Disinfection and Sterilization Agents eese B 1 CONVEX PLOWS sist ait tatipoduansat OA mue s Pup wee A E emanates B 2 DAA rale asthe NE E EAE AE AAE A AAA Sue testers Sars ere B 3 Phased Yay 0 10 tee per ORE ion dederat Pe er cadum d ene S B 4 SPC CLAN Ve PRODSS cenin e E tee soca asino docu mc eS seek Up uUa san ateusoosates uU Decet dH B 5 DODDI IP TODO etes tanti Suse t ah atadeas tc tutu ser tuf tel cacLs tat PM LS tu Roten SUE B 7 INeedleCrulde S pee onere n ictum ap E em ee tU utt eee B 8 Manutacturers oI Recommended AbenlS i iet etai pe Uy tb e d amd dine T aE Ea B 9 Appendix C Probes Electrical Safety iiie oie otic edi etu deco Eae cetna anana eia caaeaae aiaia C 1 ii 1V MyLab TRANSDUCERS AND CONSUMABLES Chapter
32. as been dropped A leakage current test see Appendix C for further details must be performed prior to re use to ensure that no electrical damage to the probe has occurred Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if it is known or suspected that it has been damaged contact ESAOTE immediately CAUTION WARNING MyLab TRANSDUCERS AND CONSUMABLES Do not try to dismantle the probe any attempt to dismantle the probe may damage it and will void the warranty In order to minimize the probability of damaging the probe the following operations are suggested e Do not touch the lens at the end of the probe Never exert force on the lens The connector is not waterproof and should always be kept dry The control unit although waterproof should not be unnecessarily immersed After use clean and or disinfect the probe as specified in this manual Invasive Transducers Invasive transducers penetrate the patient s body through an orifice or through the surface of the body Control of the Transesophageal Probe The transesophageal probe must be carefully inspected before every examination Perform a manual and visual check to ensure that there are no holes bulges tears ot dents along the entire surface of the probe Perfor
33. below the thermal limit the message disappears and the probe starts working again The Operator should either wait for the probe to cool down or interrupt the procedure and remove the probe from the patient In normal conditions the probe does not reach the thermal limit the limit may be reached in patients with fever or due to breakage of the thermal sensor A list of recommendations follows to prevent the probe from over heating e Set the B Mode angle at maximum See Chapter on Consumables for selecting these accessory Rits WARNING Transducer Rotation Dao MyLab TRANSDUCERS AND CONSUMABLES e The CFM mode is the greatest heat generator limit the use of the CFM as much as possible in patients with a high body temperature Trans gastric projections reduce heat dissipation repositioning the probe in the esophagus may make the probe cool down quickly Preparation of the Transesophageal Probe Follow the instructions below to prepare the transesophageal probe Note The Operator is recommended to wear gloves during the probe preparation procedure The use of latex transducer covers is strongly recommended along with a bite guard to protect the probe shaft These items are available as accessory kits which also contain items that facilitate placement of the probe cover on the transducer Place the tip of the probe in a straight position and release it Apply a sufficient quantity of ultrasound g
34. ber Note Esaote recommends use of sterile sheaths in laparoscopic examinations 6 2 WARNING AS Ss WARNING WARNING Electric scalpels used during the LP examination interfere with the 2D and make it impossible to use Doppler procedures WARNING MyLab TRANSDUCERS AND CONSUMABLES Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such reactions If the protective cover is damaged during the transesophageal exam on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int Be familiar with the mechanical and thermal indices display and the ALARA principle As Low As Reasonably Achievable before using the probe The patient must be exposed to ultrasound for as short a time as possible and only for as long as necessary to achieve the diagnostic information During the Examination Before probe use check to be sure that the probe name shown on the monitor is correct During the examination Esaote recommends that the Operator e Never force the probe during insertion or removal Before introducing the LP323 probe into the Trocar verify that there is no mechanical play of the tip of the probe W
35. d by Protek Medical www ptotekmedical com 7 2 WARNING WARNING Chapter 2 provides cleaning disinfection and sterilization instructions MyLab TRANSDUCERS AND CONSUMABLES Perform a visual check of the adaptor and needle guides do not use them if any damage or distortion is found Use protective sheaths during the examination These sheaths are primarily composed of latex natural rubber Note Using sterile sheaths is recommended for intraoperative and biopsy procedures Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such a reaction During the Examination Pay particular attention to the ultrasound image during the insertion of the needle into the body checking that the needle follows the displayed line The lines displayed on the monitor only provides an indication of the needle direction according to the selected guide Pay particular attention to the ultrasound image during the insertion of the needle into the body and be sure that the needle always stays within the displayed area Before performing the biopsy test check for the correct assembly and positioning of the biopsy kit Also check that the insertion angle is equal to the angle selected via the user interface software Needle insertion in a guide with an insertion angle other than that of the selected
36. ded period 2 1 WARNING MyLab TRANSDUCERS AND CONSUMABLES Do not immerse the probe cable or connector in water or other liquid Immetsion may compromise the electrical safety features The probe can be inserted in water up to the Maximum Immersion Level see Appendix A Note Probes and needle guides supplied by ESAOTE are neither disinfected nor sterilized Refer to Appendix B for a list of recommended cleaning disinfection and sterilization agents Note Damage caused by the use of not recommended agents is not covered by the warranty The disinfection sterilization agents listed are recommended because of chemical compatibility with the probe materials and not related to biological effectiveness For information related to the biological effectiveness of a disinfectant refer to the guidelines and recommendations of the disinfectant manufacturer Use of solutions other than those referenced is not recommended They may damage the probe housing or acoustic lens Follow the instructions provided by the manufacturer of the agent for proper use Personnel should adopt all necessary protective measures during the probe cleaning disinfection and sterilization processes ie gloves protective glasses Never attempt to clean or disinfect the probes while they are connected to the unit See Appendix A for description of probes Maximum Immersion Level WARNING Cleaning Procedure Probes must be
37. e been specially trained to use the probe and interpret the images Carefully review current medical provisions and follow their precautions and recommendations concerning the preparation and positioning of the patient probe insertion and manipulation techniques Do not use the intraoperative probe in direct contact with the heart the central circulatory system and the central nervous system Before the Examination Before each examination e Perform a manual and visual inspection of the entire probe prior to use see Chapter 2 of this manual DO NOT use the probe if it has been damaged or if damage is suspected Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against these damages nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if damage is known or suspected e Use protective sheaths during the examination These sheaths are usually composed of latex natural rubber Note 5 2 MyLab TRANSDUCERS AND CONSUMABLES During the probe preparation procedure the operator is recommended to wear gloves See Chapter 8 on consumables for choosing gel and rM Apply enough ultrasound gel inside the sheath The probe sheaths may contain natural rubber latex which may cause allergic reactions Make sure that patients who are allergic to latex are identified before each examination Serious allergic reaction
38. e damaged do not use the probe and have it repaired Breaks in the probe casing or in the cable could expose the patient and or the operator to an electrical safety risk Do not use a probe if it has been dropped A leakage current test see Appendix C for further details must be performed prior to re use to ensure that no electrical damage to the probe has occurred In case of incorrect operation of the flexion do not use the probe and call Esaote Service Assistance Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if it is known or suspected that it has been damaged contact ESAOTE immediately Do not try to dismantle the probe any attempt to dismantle the probe may damage it and will annul the guarantee In order to minimize the probability of damaging the probe the following operations ate suggested e Do not touch the lens at the front of the probe Never exert force on the lens The connector is not waterproof and should always be kept dry When not in use store the probe in its case After use clean and sterilize the probe as specified in this manual CAUTION CAUTION CAUTION CAUTION MyLab TRANSDUCERS AND CONSUMABLES Storing and Protecting the Transducers Daily Storage and Protection Non Invasive Transduc
39. e irox Technologies www vitox com Sani Cloth Active Super Sani Cloth Sani cloth HB Medi Prep Milton Alkazyme Sporox II MyLab TRANSDUCERS AND CONSUMABLES B 10 WARNING WARNING MyLab TRANSDUCERS AND CONSUMABLES Appendix Appendix C Probes Electrical Safety The transesophageal endocavitary intraoperative and laparoscopic probes produced by Esaote are classified as Type BF applied parts To ensure electrical safety both to the patient and the operator it is necessary to check the physical integrity of the probe and to have the system correctly grounded It is important to check on a regular basis the electrical safety of probes used in semi critical such as transesofageal endocavitary and critical intraoperative laparoscopic applications according to what stated by the EN60601 1 standard This means that the procedures adopted to check probes must also include a leakage current measurement Do not use a probe which underwent any kind of shock or whose integrity has been compromized carefully read Chapter 1 of this manual until its electrical integrity has been defined by a leakage current measurement Contact your local ESAOTE representative The leakage current measurement must be performed by a qualified person using some test equipment complying with the standatds Note Before performing the measurement make sure that the test equipment is correctly calibrated The below de
40. el inside the sheath The protective sheaths available on the market often contain latex Make sute that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such reactions e Completely unroll the sheath along the transducer body making it adhere so as to avoid ait pockets Secure the sheath with the rubber band provided Transducer Orientation The probe handle wheels can be used to rotate the transducer inside the tip or to change the tip position The rotation of the transducer is controlled by the smallest knob and is adjustable from 0 to 180 In the zero position the transducer will scan the transversal plane The zero 90 and 180 positions are marked on the knob The MyLab system screen displays the transducer s current orientation 3 5 Tip Position During probe insertion make sure that the tip is unlocked grey locking device MyLab TRANSDUCERS AND CONSUMABLES The probe tip can be oriented to optimize tissue contact The articulation of the flexibile part of the probe is controlled by the largest knob up and back wards adjsutments are feasable e 120 upwards clockwise rotation of the knob e 90 backwards counter clockwise rotation of the knob The zero position is marked on the knob This knob can be locked into position by engaging the locking device located next to the kn
41. er Probes Accel RTU Anios Detergent Desinfectant Cidex Cidex Activated Dialdehyde Solution Cidex OPA Cidexplus Enzol Cydezime Gigasept 10 vol Gigasept FF Hexanios G R Medi Prep Metricide Milton Omnicide 2 25 PreCept RTU Sani cloth Active Steranios Transeptic Spray T Spray T Spray II Virkon Wavicide 01 2CW J D S GO GO O A a D S J OC Xu qv D S 5CW J D S Cc te c AO EPI MW D S DOTY CR uu D S HF CW x g eA O pA 9X pA KK KK pA oA OO KKK KH MK B 7 MyLab TRANSDUCERS AND CONSUMABLES Needle Guides ABS421 ABS621 ABS523 ABS424 ABS123 ABS15 Accel RTU C C C C C C Anios Detergent C C C C C C Desinfectant Cidex D D D X D D Cidex amp OPA D D D X D D Cidexplus D S D S D S X D S D S ComplianceTM D S D S D S D S D S D S Enzol Cydezime C C C C C C Gigasept 10 vol D D D X D D Gigasept FF D D D X D D Hexanios G R C C C C C C Medi Prep C C C C C C Metricide X S S X X S Milton C C C C C C Omnicide 2 25 D S D S D S X D S D S Perasafe S S S X S S PreCept RTU C C C C C C Sani cloth Active C C C C C G Steam autoclave S S S S S S Steranios D D D X D D Steris 5 5 5 X X X Transeptic Spray C C C C C G T Spray C C C C C C T Spray II C C C C C C Virkon D D D X D D Wavicide 01 D S D S D S X D S D S Besides the agents indicated in the table all compatible sterilization methods for surgical instruments can be applied to the ABS15
42. ers When not in use the transducer must be stored in the special probes slot on the machine If all the available slots are full place the probe in its case All gel must always be cleaned off the probe see the next chapter for the relative instructions Always keep the probe in its case Otherwise it could be accidentally dropped or damaged Storing and Protecting the Transesophageal Probe The probe must always be cleaned following the instructions provided in the next chapter The probe must be kept in a clean environment and with the endoscope straight In particular we recommend using e Wall mounted supports A storage drawer that is large enough to house the endoscope bending it as little as possible Storing and Protecting the Endocavity Probe The probe must always be cleaned following the instructions provided in the next chapter When not in use the transducer must be stored in the special probes slot on the machine If all the available slots are full place the probe in its case Always keep the probe in its case Otherwise it could be accidentally dropped or damaged Storing and Protecting the Intraoperative and Laparoscopic Probe The probe must always be cleaned following the instructions provided in the next chapter When not in use place the probe in its case Always keep the probe in its case Otherwise it could be accidentally dropped or damaged Transport or Long Term Storage and Protection All tran
43. evel 12532 Up to 3 cm from transducer head LA424 Up to 3 cm from transducer head LA435 Up to 3 cm from transducer head 1 522 Up to 3 cm from transducer head LA523P Up to 3 cm from transducer head LA523 Up to 3 cm from transducer head 14 532 Up to 3 cm from transducer head LA923 Up to 3 cm from transducer head Transesophageal Adults Transesophageal Pediatric Endocavity MyLab TRANSDUCERS AND CONSUMABLES Convex Probes Probe ID Maximum immersion level CA123 Up to 3 cm from transducer head C5 2 R13 Up to 3 cm from transducer head CA421 Up to 3 cm from transducer head CA1421 Up to 3 cm from transducer head CA430 Up to 3 cm from transducer head CA541 Up to 3 cm from transducer head CA431 Up to 3 cm from transducer head CA621 Up to 3 cm from transducer head CA631 Up to 3 cm from transducer head CAB411A Up to 4 cm from transducer head Specialty Probes Probe ID TEERO022 Technology Phased Array Imaging plane 0 1800 Maximum immersion level Up to 1 m from transducer head Probe ID TEE122 TEE132 Technology Phased Array Imaging plane 0 1809 Maximum immersion level Up to 70 cm from transducer head Probe ID EC123 Technology Convex Array Imaging plane Sagittal Maximum immersion level Up to 25 cm from transducer head Probe ID E8 5 R10P Technology Convex Array Imaging plane Sagittal Maximum immersion level Up to 25 cm from transducer head Probe ID EC1123 Technology Convex Array Imaging plane Sagittal Maximu
44. extensions of the attachment 3 Press the transducer inside the holder hearing a click to assure secure and complete insertion Fai E P il E T p yp ee a um uer j z i Pa _ m Eb Pul s J d eo P dic T 4 To remove the sled attachment reverse the procedure 5 8 MyLab TRANSDUCERS AND CONSUMABLES Chapter 9 6 The Laparoscopic Probe The laparoscopic probe LP323 is a Type BF part The probe must be physically intact and the system properly grounded for the electrical safety of the patient and operator Read the Safety and Standards Manual carefully all the safety characteristics cautions and warnings listed also apply to the use of this probe In particular remember that RE aaa The system must be properly grounded it must be supplied from a socket equipped with a protective ground connection Mobile configurations are fitted with insulated supply sockets for supplying electricity to the systems without increasing the leakage current Incorrect connections or failure to use insulated sockets may compromise electrical safety If in doubt about the protective ground connection DO NOT use the probe and contact ESAOTE immediately Characteristics and Components The LP323 incorporates a high frequency linear transducer for laparoscopic scanning The probe is delivered with the following accessories e Storage ca
45. f damaging the probe the following operations are suggested e Do not touch the lens at the front of the probe Never exert force on the lens e The connector is not waterproof and should always be kept dry Before inserting the probe do not rub or spray the tip of the probe with an anesthetic agent When not in use store the probe as specified in the next paragraph After use clean and disinfect the probe as specified in this manual Control of the Endocavity Probe The endocavity probe must be checked before every examination Perform both a visual and manual check to ensure that there are no holes bulges abrasions or dents Perform a visual and manual check of the probe cable cuts or holes in the cable may jeopardize electrical safety e The connector pins are not bent If the pins are damaged do not use the probe and have it repaired Breaks in the probe casing or in the cable could expose the patient and or operator to an electrical safety risk Do not use a probe if it has been dropped A leakage current test see Appendix C for further details must be performed prior to re use to ensure that no electrical damage to the probe has occurred Physical damage to the probe may cause electric shock or mechanical injuty to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if it is known or
46. gistered brand MyLab TRANSDUCERS AND CONSUMABLES Chapter O 9 8 Accessories and Consumables ECG Cable The leads on the ECG cable supplied by Esaote ate equipped with a pliers terminal Any button electrode can be used with the ECG cable We recommend using disposable Ag AgCl electrodes Read the manufacturer s instructions carefully for correct use of the electrodes Checking the ECG Cable A periodic check should be made of the ECG cable Disconnect the cable from the system and check that there are no breaks or slits Note Esaote recommends replacing the ECG cable if there are any breaks ot slits Cleaning and Disinfecting the ECG Cable Periodically clean the ECG cable and electrodes so that they remain in optimal working order Never try to clean or disinfect the ECG cable when it is still connected to the unit The equipment listed in the following table will be necessary for periodic maintenance procedutes Agent Destined for Solution of mild soap and water Cleaning the ECG cable and electrodes CIDEX OPA Disinfecting the ECG cable Indicated by the manufacturer Disinfecting the electrodes Cleaning Procedure CAUTION Disinfection Procedure MyLab TRANSDUCERS AND CONSUMABLES Disconnect the cable from the system Dust the cable coupling with a soft cloth Clean the cable by rubbing it gently with a soft cloth dampened with water and a mild detergent Do not immerse the ECG
47. guide is sterile but cannot be re sterilized For a correct use of the disposable biopsy kit please refer to the manufacturer s instruction Biopsy kit for the TRI33 probe MyLab TRANSDUCERS AND CONSUMABLES Note e The use of sterile covers is mandatory for all endocavity scans e Please pay attention not to have gel on the shaft of the probe where the holes for biopsy kit connection are Mounting the ABS Trans rectal Probe Needle Guide The trans rectal biopsy kit is composed of two patts the coupling to be connected to the probe and the needle guide device Needle guide Vertical Guide Longitudinal position sliding black Longrtudinal position sliding block screw The position of the needle guide is adjustable both in length and in depth The longitudinal adjustment is performed by the horizontal sliding of the vertical guide onto the horizontal guide The attachment is made by the longitudinal position sliding block WARNING MyLab TRANSDUCERS AND CONSUMABLES The vertical adjustment allows the user to change the needle depth in the linear transducer field of view and is performed by sliding the needle guide along the vertical track To guarantee the precision of the adjustment the vertical guide has a scale in centimeters lcm to 5cm corresponding to the depth shown in the ultrasound image the needle guide has two notches to indicate each of the two guides for the supported needles By rotati
48. h the probe 5 6 MyLab TRANSDUCERS AND CONSUMABLES finger attachment transducer The finger attachment can be used in four different configurations in order to mote closely adapt to the surface being evaluated In intraoperative applications it is possible to insert the probe below adjacent to or on top of the structure of interest Following are the four different IOE323 probe attachment designs eee ae E 5 4 Er M ue s ale i TA E LI ht Pi a f 5 Ms wf Ly as E ee ad R ee lm if PW i N pe Lx ae pr e Moe 1 m m hM x oi qe Ba T L mMm l re 5 E x p oe m 2 E ae 7 fof T A E d Sled Attachment The sled attachment has been developed to provide easier manipulation of the probe during both intraoperative and superficial scanning The attachment corresponds to the ergonomics of the probe and is the same length as the transducer The correct position of the SLED attachment is shown below 5 7 MyLab TRANSDUCERS AND CONSUMABLES To place the attachment on the probe follow the procedure described below The sequence is also shown in the following design 1 Place the sled attachment at the tip of the transducer E E ps ue sU aw qu uet E sl E E H Pd bh d un E E m E a LI 2 Rotate the sled attachment around the probe until it is safely in place between the two lateral
49. hile inserting the LP323 probe into the Trocar the tip of the probe should be in a straight position Forced insertion ot removal may harm the patient e Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro organisms 1s suspected Electric scalpels and other devices that introduce radio frequency or electro magnetic current fields into the patient interfere with ultrasound images While using the system in combination with high frequency devices like electro surgical units be aware that a failure in the surgical device or a damage to the transducer lens can cause electro surgical currents that can burn the patient Thoroughly check the system and the probe before applying HF surgical currents to the patient Disconnect the probe when not imaging Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically Perform a manual and visual check before each examination to ensure that the probe is intact 6 3 See Chapter 8 on consumables for selecting the gel and sheathes WARNING MyLab TRANSDUCERS AND CONSUMABLES At the End of the Examination At the end of the examination Esaote recommends that the Operator e Clean and disinfect the probe according to the instructions provided in Chapter 2 of this manual e
50. le e Suck air back into the syringe close the tap to remove the syringe and expel the air Repeat this procedure until all the air bubbles have been eliminated Replace water without air back into the syringe and close the valve leave the tube and the syringe connected Apply ultrasound examination gel to the tip of the stand off Cover the portion of the probe that is to be inserted with the protection cap The protective sheaths available on the market often contain latex Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such reactions To make insertion easier apply some lubricating gel to the tip of the probe Once the probe is in the correct position fill the stand off with water again To optimize image quality use enough water to ensure that the probe adheres as well as possible to the rectal wall Do not remove the probe from the rectum if the probe tip is still full of water 4 4 aD SS WARNING MyLab TRANSDUCERS AND CONSUMABLES Chapter 9 The Intraoperative Probe The intraoperative probe IOE323 is a Type BF part The probe must be physically intact and the system properly grounded for the electrical safety of the patient and operator Carefully read the Safety and Standards Manual all safety characteristics cautions and warnings li
51. ltrasound images While using the system in combination with high frequency devices like electro surgical units be aware that a failure in the surgical device ot a damage to the transducer lens can cause electro surgical currents that can burn the patient Thoroughly check the system and the probe before applying HF surgical currents to the patient Disconnect the probe when not imaging Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically Perform a manual and visual check before each examination to ensure that the probe is intact At the End of the Examination At the end of the examination Esaote recommends the Operator to Clean and disinfect the probe according to the instructions provided in Chapter 2 of this manual e Store the probe as indicated in Chapter 1 of this manual Preparation of the Endocavity Probes Follow the instructions below for preparing the endocavity probe Note The Operator is recommended to wear gloves during the probe preparation procedure Apply a sufficient quantity of ultrasound gel inside the sheath The protective sheaths available on the market often contain latex Make sute that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator sh
52. m a manual and visual check of the endoscope while bending the tip in all possible directions deflection must function according to characteristics and the guides must not protrude during these movements Check that the deflection mechanism functions in both modes free or with friction Check the cable manually and visually there must be no cuts or irregularities Check that the connector pins are not bent If the pins are damaged do not use the probe and have it repaired Breaks in the probe casing or in the cable could expose the patient and or the operator to an electrical safety risk Do not use a probe if it has been dropped A leakage current test see Appendix C for further details must be performed prior to re use to ensure that no electrical damage to the probe has occurred In case of incorrect operation of the flexion do not use the probe and call Esaote Service Assistance Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such CAUTION WARNING CAUTION MyLab TRANSDUCERS AND CONSUMABLES damage nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if it is known or suspected that it has been damaged contact ESAOTE immediately Do not try to dismantle the probe any attempt to dismantle the probe may damage it and will void the warranty In order to minimize the probability o
53. m immersion level Up to 28 cm from transducer head Transrectal Intraoperative Laparoscopic BiScan Convex BiScan Endocavity Continuous Wave Technology Imaging planes Maximum immersion level Technology Maximum immersion level Technology Maximum immersion level Technology Maximum immersion level Technology Imaging plane Maximum immersion level Doppler Probes TRANSDUCERS AND CONSUMABLES Probe ID TRT33 Convex Linear Array Transversal and Longitudinal Up to 25 cm from transducer head Probe ID IOE323 Linear Array Up to 10 cm from transducer head Probe ID LP323 Linear Array Up to 50 cm from transducer head Probe ID BC431 Convex Array Up to 9 5 cm from transducer head Probe ID BE1123 Convex Array Sagittal Up to 17 5 cm from transducer head Probe ID Maximum immersion level 2 CW Up to 6 cm from transducer surface 5 CW Up to 6 cm from transducer surface HF CW Up to 6 cm from transducer surface A 3 MyLab TRANSDUCERS AND CONSUMABLES WARNING MyLab TRANSDUCERS AND CONSUMABLES Appendix Appendix B Gables and Consumables ECG Cables This chapter provides a list of MyLab ECG cables with their main characteristics refer to your system documentation for ECG capabilities Reference Description 9630028000 3 Leads ECG Cable IEC Colours 9630028010 3 Leads ECG Cable AHA Colours Recommended Consumables Below is the recommended si
54. m on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int Connect the kit to the probe positioning the two alignment pins on the special notches on the probe Needle Needle guide Holder JP Needle guide W fixing screw Alignment pivots Hinge Hinge fixing screw e Close the clamp and tighten it using the special ratchet Insert the needle guide and tighten it onto the coupling The EC123 probe is also available with Type X disposable biopsy kit The kit can also be ordered from CIVCO Manufacturer Manufacturer s Contents kit code CIVCO Medical Instruments 610 693 Disposable sterile kit with needle guide Inc Kalona IA USA 2x20cm sheath 3 5x20cm sheath seal and gel The assembly procedure for this kit is identical to that of the metal biopsy kit the biopsy kit must be attached to the probe using the alignment pivots The plastic disposable guide is sterile but cannot be re sterilized For a correct use of the disposable biopsy kit please refer to the manufacturer s instruction Note e The use of sterile covers is mandatory for all endocavity scans 5 Civco Medical Instruments Kalona Iowa www civco com 7 9 MyLab TRANSDUCERS AND CONSUMABLES e Please pay attention not to have gel on the shaft of the
55. move the probe handle provides a locking device which must be set to loose position Use protective sheaths during the examination These sheaths are mainly composed of latex natural rubber 3 2 WARNING WARNING CAUTION WARNING WARNING Electric scalpels used during the TEE examination interfere with the 2D and make it impossible to use Doppler procedures MyLab TRANSDUCERS AND CONSUMABLES Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such reactions If the protective cover is damaged during the transesophageal exam on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int Always use a bite proof mouthpiece to protect the probe from the patient s teeth Physical damage to the probe can cause electrical or mechanical injury to the patient Damage caused to the probe due to failure to use a protective mouthpiece is not covered by the guarantee Be familiar with the mechanical and thermal indices display and the ALARA principle As Low As Reasonably Achievable before using the probe The patient must be exposed to ultrasound for as short a time as possible and only for as long
56. n with high frequency devices like electro surgical units be aware that a failure in the surgical device or a damage to the transducer lens can cause electro surgical currents that can burn the patient Thoroughly check the system and the probe before applying HF surgical currents to the patient Disconnect the probe when not imaging Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically Perform a manual and visual check before each examination to ensure that the probe is intact At the End of the Examination At the end of the examination Esaote recommends the Operator to e Clean and disinfect the probe according to the instructions provided in Chapter 2 of this manual e Store the probe as indicated in Chapter 1 of this manual Temperature Control Transesophageal probes are equipped with a temperature sensor to provide continuous feed back on the temperature of the probe tip the ultrasound scanner constantly samples and displays the probe temperature Once the probe is connected the temperature is displayed on the screen To ensure patient safety the ultrasound scanner allows a maximum temperature of 42 5 C 108 5 F if the probe reaches this limit the system automatically de activates and displays a warning message As soon as the temperature goes down
57. ng the needle guide the user can select the gauge The Needle guide fixing pawl holds the guide in place e Make sure that the probe has been disinfected Apply ultrasound examination gel to the probe or to the tip of the protection cap Cover the probe with the protective cap secure with the rubber band provided The protective sheaths available on the market often contain latex Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle such a reaction If the protective cover is damaged during the exam on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int Connect the horizontal guide to the probe positioning it on the groove on the probe and screwing the attachment system Adjust the needle guide on the vertical guide to choose the correct depth for the exam e Slide the vertical guide on the horizontal one so that it fits in the desired position Attach the vertical guide with the longitudinal position sliding screw Insert the needle into the guide paying particular attention to choose the correct needle guide hole To disassemble the biopsy kit reverse the previous proced
58. ngle use electrodes the product has been tested for compatibility with the ESAOTE MyLab systems Type Product Manufacturer Single Use Electrodes Excel 3040 050 Ludlow Technical Products Massachusetts USA Cleaning Disinfection and Sterilization Agents The following tables list the MyLab probes and the recommended cleaning C disinfection D and sterilization S agents X means Do Not Use Note Damage caused by the use of not recommended agents is not covered by the warranty Follow the instructions provided by the manufacturer of the agent for proper use B 1 Accel RTU Alkazyme Anioxyde 1000 Anios Detergent Desinfectant Assepti Wipes II CaviWipes Cidex OPA Cidexplus Compliance Enzol Cydezime Gigasept 10 vol Gigasept FF Hexanios G R Klenzyme Medi Prep Medister Metricide Milton NuCidex Omnicide 2 25 Perasafe PreCept RTU Salvanios Sani cloth Active SeptiWipes Ster Bac Blu Super Sani cloth Resert HLD ex Secure HLD Sporox II Steranios Transeptic Spray T Spray T Spray II Virkon Wavicide 01 MyLab TRANSDUCERS AND CONSUMABLES Convex Probes CA123 C5 2 R13 C G X X X X C G X X D D D S D S X X C C D D D D C C X X C G S X S S C X X X D S D S X X C C X X C C X X X X X X X X X X D D C e C G C C D D D S D S CA421 C X X C OK Mh MM OMAnM SH ao uwaomMagdan dg daco v x D S CA1421 C X X C O
59. ob This locking device has two color coded positions on red the tip is locked on grey the tip is loose 3 6 MyLab TRANSDUCERS AND CONSUMABLES Chapter 4 The Endocavity Probes The endocavity EC123 EC1123 E8 5 R10P and BE1123 and transrectal TRT33 probes are Type BF parts As per directive EN60601 1 the probe must be physically intact and the system correctly grounded for the electrical safety of the patient and operator fir Read the Safety and Standards Manual carefully all the safety SS characteristics cautions and warnings listed also apply to the use of this probe In particular remember that CPU E Ep The system must be correctly grounded it must be supplied from a socket equipped with a protective earth connection Mobile configurations are fitted with insulated supply sockets for supplying documentation systems without increasing the leakage current Incorrect connections or failure to use insulated sockets may compromise electrical safety In case of doubts about the protective earth connection DO NOT use the probe and contact ESAOTE immediately Characteristics and Components The EC123 EC1123 E8 5 R10P and BE1123 probes incorporate a high frequency convex transducer for sagittal transverse endorectal or endovaginal scanning The TRT33 incorporates both a convex transducer and a linear transducer for longitudinal and transversal scanning The EC123 and TRT33 probes are delivered
60. ontrol and the transducer rotational knob 3 1 TEE probes are delivered with a CATTyIRE case The user must know how to recognise contraindications to the examination and any possible complications such as tip buckling WARNING MyLab TRANSDUCERS AND CONSUMABLES 3 Locking device 4 Probe shaft this shaft has a length of 100 cm and is labelled in 10 cm increments 5 Probe tip with the ultrasound transducer Examination Safety The transesophageal examination is to be carried out by operators who have been specially trained to insert the probe and interpret the images Carefully review current medical provisions and follow their precautions and recommendations concerning the preparation and positioning of the patient probe insertion and manipulation techniques Before the Examination Before each examination Perform a manual and visual inspection of the entire probe see Chapter 2 of this manual DO NOT use the probe if it has been damaged or if damage is suspected Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if you know or suspect that it has been damaged Check that the probe deflection controls function correctly in all directions and that they have not jammed Make sure that the probe tip is free to
61. ould be prepared to handle such reactions e Completely unroll the sheath along the transducer body making it adhere so as to avoid ait pockets Secure the sheath with the rubber band provided Eliminate the air bubbles between the transducer and the sheath air bubbles impede the transmission of ultrasound WARNING MyLab TRANSDUCERS AND CONSUMABLES e To make it easier to insert the endocavity probe apply some water based lubricating gel on the tip of the transducer Water Stand Off for EC123 EC1123 and TRT33 Probes Both EC123 EC1123 and TRT33 endocavity probes have two communicating holes one at the tip and one at the base that make it possible to use water stand off to optimize probe adherence in transrectal examinations The probes are equipped with a 60 cc syringe with tubes that allow water to be injected Covet the part of the probe that can be immersed with the stand off cap and attach it with the rubber band provided at about 5 cm from the tip make sure the water intake hole is below the band e Filla 60 cc syringe with sterile water Apply the tap valve to the syringe Connect a section of the IV tube to one end of the tap the other end of the IV tube must be inserted into the probe filling hole Open the tap inject about 30 cc of water into the probe e To eliminate air bubbles turn the probe upwards holding it by the handle the bubbles will rise towards the water intake ho
62. ounted on its case to avoid fluid leaks or air bubbles e Immetse the stand off into water before each use e Apply ultrasound gel on the probe e Place the stand off on the probe sliding it till some gel comes out from the lower part of the pocket on the base of the filling tube e Apply ultrasound gel on the stand off between the contact pocket and the patient When the stand off is not used it is recommended to store it far from light sources to avoid early ageing of the rubber The stand off is made of natural rubber and can be cleaned with a mild soap Thoroughly rinse it with water expecially after each contact with disinfectant agents The use of germicidal lamps and or disinfectant agents containing quaternary ammonium compound is not recommended as they could damage the stand off To dry the stand off use warm air at 60 or a clean cloth Sterilization cam be performed in autoclave at 134 C for 20 minutes if the contact pocket doesn t contain ultrasound gel Ge Transmission gel must always be applied to probes to obtain correct probe patient contact Esaote recommends only using water or glycerine based ultrasound gel Do not use gels containing the substances listed below The transducer could be damaged if such gels are used Always check the gel composition before using it Note Any damage caused by the use of gels containing the below listed components is not covered by the warranty 8 3 Sub
63. probe where the holes for biopsy kit connection are E8 5 R10P Endocavity Probe The E8 5 R10P probe is available with Type O disposable biopsy kit with 3 coupling angle The kit can be ordered from CIVCO Manufacturer Manufacturer s Contents kit code CIVCO Medical Instruments 610 543 Disposable sterile kit with needle guide Inc Kalona IA USA 2x20cm sheath seal and gel The assembly procedure for this kit is identical to the one described for the metal needle guide the needle guide must be attached to the probe using the alignment pivots The plastic disposable guide is sterile but cannot be re sterilized For a correct use of the disposable biopsy kit please refer to the manufacturer s instruction Note e The use of sterile covers is mandatory for all endocavity scans e Please pay attention not to have gel on the shaft of the probe where the holes for biopsy kit connection are EC1123 Endocavity Probe The EC1123 probe is available with Type X disposable biopsy kit with 3 8 coupling angle The kit can also be ordered from CIVCO Manufacturer Manufacturer s Contents kit code CIVCO Medical Instruments 610 693 Disposable sterile kit with needle guide Inc Kalona LA USA 2x20cm sheath 3 5x20cm sheath seal and gel The assembly procedure for this kit is identical to the one described for the metal needle guide the needle guide must be attached to the probe using the alignment pivots The plastic disposable
64. r o nete 5 1 Characteristics abd OMmpOneMmts omite a dune ete does ta den tiec aout Ee aces 5 E ani gos dle D dutem tomes fO DI ume EFL DUE NI ei men ea 5 2 Beroe EEIN O suo e E Meet desees uteddimei e E DU Seer ee esed 5 3 D rinb the Examina onerare cneiaeoishe a put aseo A en eee eee t sud 5 4 At the End of the Examination c ccc ccc cccecccccccecccccccecceccececceccecescecesceecessscescscecescscesescesenseess 5 4 Using the 10B525 Intraoperauve Proberen ene tied ont er boim aen E ela tud edes 5 5 Hdl Attachment 4s cece aie in piae b paetos a net tedidniquo v qd tio veu EE nep uin eteE 5 6 Liner Aba HERE DD 3e titius coetui eimi ues seta teed IT Do ete edust escas o seti te E Oo Potete ratte 5 7 UIS PENDET MN E a Pe T 5 8 6 The Eaparoscopic Prove sooo et ior REMIS Eee EY RII REUS EON E III MUS E 6 1 Characteristics and CormponeHlls ne mapa Um ER ba de etam Rae ta dU MR CD MU EU PLE TUUS 6 1 Exarmtiatton Sdfelyeeesid esiste ei odpvent ste R ese edu scooter issue ctu dtt edad vae sitame nnd 6 2 Betor tne Fe x aii atl Oia aoo REUNIR EROR AN MARII DM E ed anaes 6 2 Durme the Examtindt lou ooo ud pte CO HERE A d desta pls m AM EA a iid Gin ad ASA EIN DRE 6 3 At E Bnd or the Exanimallolss siae e a ERG edi e aa REO vede bs 6 4 Preparado of the L4paroscople PEODS 24 treten uta ek ese ees 6 4 MEE IIR i cm 7 1 Examina omo ae y cot tnt a a tM n uU eee c M A MEI SPON 7 2 B Porte MCEI Mina ON seo tiet tuit net art tte cxt aed E et eee EH
65. ransesophageal probes TEE022 TEE122 and TEE132 are a Type BF part The probe must be physically intact and the system correctly grounded for the electrical safety of the patient and operator Read the Safety and Standards Manual carefully all the safety characteristics cautions and warnings listed also apply to the use of this probe mn ss In particular remember that The system must be correctly grounded it must be supplied from a socket WARNING equipped with a protective earth connection Mobile configurations are fitted with insulated supply sockets for supplying documentation systems without increasing the current leakage Incorrect connections or failure to use insulated sockets may compromise electrical safety In case of doubts about the protective earth connection DO NOT use the probe and contact ESAOTE immediately Characteristics and Components The TEEO22 TEE122 and TEE132 transesophageal probes are designed for transesophageal imaging of the heart in adult and pediatric patients respectively The transesophageal probe incorporates an array transducer which can be rotated 180 to easily obtain all imaging planes The probe tip can also be deflected for optimal coupling These probes are equipped with a temperature sensor MyLab models ate designed to use these sensor thermal data to prevent probe tip overheating Components 1 Probe cable and system connector 2 Probe handle with the probe tip deflection c
66. requent usage requires more frequent controls 1 1 WARNING WARNING MyLab TRANSDUCERS AND CONSUMABLES Operation to be performed Frequency Physical control of non invasive probes Every month or when the probe is dropped Physical control of transesophageal endocavity Before every examination intraoperative and laparoscopic probes Physical control of the biopsy kit Before every examination and if dropped Never use a probe if it has been dropped until you are sure that no electrical damage to the probe has occurred This can be done by performing a leakage current test see Appendix C for further details Transducer Controls Non invasive Transducers Non invasive transducers are intended to be used on the external parts of the body only A periodic control must be made on transducers to check that e The housing is intact If cracks or breaks are found have the probe repaired immediately by contacting an ESAOTE technician e The lens does not have any irregularities or is not broken If any breaks are found on the scanning windows do not use the probe again and have it repaired The probe cable is not broken or damaged If any damage is found do not use the probe again and have it repaired The connector pins are not bent If the pins are damaged do not use the probe and have it repaired Breaks to the probe casing or to the cable could result in risks to electrical safety Do not use a probe if it h
67. s Ip Edu acsi ele a d OI p Ede esi UE ease a odo up eausa 3 Examination SALCLY cseeuetusaueo niue aque iunt ie E absens eter aah icici teo n eden heed anb ine ues teo eas 3 2 Beror the P dipole aeiostes intuenti tendi idet itp emi fendi leue atest iaE temo tendi dolest 3 2 D nns the PFXarmidtloti su cie asy ipi tc imo ao euis ecu educd uation ostia acia 3 3 Abe Bund orthe Ea AU OM assente a E beth Detatiitelo qe iani nituias 3 4 d wis cue ne Re aN 3 4 Preparation of the Transe sophaseal Probe eoo rettet Eq HERO RS ed bet ls eee 3 5 Transducer OLI ntatlOTE sariren dores doen tiber ode le eon audae demens liene dece suadeat indes 3 5 4 The Endocavity PEODOS erii EE EE LPe euet e a ee ie e ie EEive de Eee ea ded 4 1 Characteristics and COMPONEN S seen rien ker iet H i epe ONT Eo ie Lese Mes i ipe ib eerie eaten 4 Examinatiopsdfely aad dt mieten tat metadata toda te actos 4 2 Belore the Examina NON eroe ott dn ia tette dit ade eint ia cH eu te te itu iiit e dud a uti iuda 4 2 Durinb tie TI xamimdbtiollsso ode onto OB Ee E et ERI DRE Ron beu estore eae uuu direi 4 2 At th End or the EXamnmmiatiOfis so edi E d tees ab iia di hu aS 4 3 Preparation 0f the Bndocaviby Probe iue onn prote i RE ne rp ra ER mua Enel aiiud ea ri 4 3 Water Stand Off for EC123 EC1123 and TRT33 Probes eene 4 4 5 The lnttcdopeEative PrODG 25d eov repete eio Oeo eae rx dese pat beA euo na nee eese ER aoa
68. s to latex have been reported the Operator should be prepared to handle such reactions WARNING Note Esaote recommends the use of sterile sheaths in intraoperative examinations e Completely unroll the sheath along the transducer body fitting it tightly so to avoid air pockets Secure the sheath with the rubber band es lf the protective cover is damaged during the transesophageal exam on WARNING patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int Note Esaote recommends use of sterile sheaths in intraoperative examinations ag The operator must be familiar with the mechanical and thermal indices display and SS the ALARA principle As Low As Reasonably Achievable before using the probe The patient must be exposed to ultrasound for as short a time as possible and only for as long as necessaty to achieve the diagnostic information During the Examination Before probe use check to be sure that the probe name shown on the monitor is correct WARNING During the examination Esaote recommends that the Operator e Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro organisms is suspected 5 3 Electric scalpels used during the IOE examination interfere with the 2D
69. scribed procedure refers to ULT800 www flukebiomedical com measurement device for further details on its use please refer to the manufacturer s user manual Any other equipment complying with the standards can be used referring to the corresponding user manuals During the test do not touch either the electrodes or the liquid where the probe is immersed During the test a high voltage is applied on the electrodes Do not immerse the probe cable or connector into water or other liquids Immersion may compromise the electrical safety features The probe can be inserted ino water up to its Maximum Immersion Level see Appendix A MyLab TRANSDUCERS AND CONSUMABLES Procedure e Connect the probe to the adapter available on the measurement device e Turn the measurement device on and wait till it s ready to work e Immerse the probe into a saline solution or Cidex e Place the electrodes into the saline solution e Connect both the electrodes and the probe adaptor to the tester e Run first the conductivity test and then the leakage current test If the leakage current test gives a negative result do not use the probe and WARNING contact your local ESAOTE representative Legenda 1 Measuring device 2 Conductivity sensor 3 Probe adapter 4 Water tank filled with Cidex or saline solution 5 Probe to be examined C 2
70. sducers are supplied with their own case that must always be used both when transporting the probe and for long term storage Clean the transducer carefully following the procedures described in the following chapter before putting the probe away in its case For long term storage check that the environmental requirements indicated on the label of the case ate observed Always use the original case to store the transesophageal probe The special shape of this case prevents damage to the gastroscope due to excessive bending 1 7 MyLab TRANSDUCERS AND CONSUMABLES Dispatching the Transducer Contact Esaote personnel to ensure that the transducer is correctly packed before dispatching it Needle Guide Kit Control Always check that The socket is not bent Do not use the socket if it has been damaged The needle guide is not bent Do not use the guide if it has been damaged Storing and Protecting Needle Guide Kits All biopsy kits are supplied with their own case We recommend leaving any unused needle guides in the case The kits must always be sterilized after use see the next chapter for procedures Please refer to the procedures used on site for storing sterile parts WARNING MyLab TRANSDUCERS AND CONSUMABLES 2 Cleaning and and Biopsy Kits Chapter Disinfecting Transducers Periodic Cleaning and Disinfecting Schedule The following table describes the periodic maintenance to be carried out on
71. se e Sterilization bowl 6 1 LP323 Probe WARNING WARNING MyLab TRANSDUCERS AND CONSUMABLES The LP323 probe has an articulation that allows a double movement of its extremity in order to position the transducer directly on to the surface of the organ under evaluation This movement is adjustable by two control levers located on the probe handle Examination Safety The laproscopic examination is to be carried out by operators who have been specially trained to use the probe and interpret the images Carefully review current medical provisions and follow their precautions and recommendations concerning the preparation and positioning of the patient probe insertion and manipulation techniques Do not use the laparoscopic probe in direct contact with the heart the central circulatory system and the central nervous system Before the Examination Before each examination e Perform a manual and visual inspection of the entire probe prior to use see Chapter 2 of this manual DO NOT use the probe if it has been damaged or if damage is suspected Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against these damages nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if damage is known or suspected e Use protective sheaths during the examination These sheaths are usually composed of latex natural rub
72. stances to Be Excluded LA CA and BC431 Probes EC123 EC1123 BE1123 and TRT33 Probes MyLab TRANSDUCERS AND CONSUMABLES 9 acetone methanol ethanol isopropyl alcohol denatured ethyl alcohol mineral oil 9 iodine anylotion or gel containing perfume glycol The following table indicates ultrasound gels that have tested compatibility with MyLab Product Supplier Aquasonic Parker Laboratories Inc Scan New Jersey USA Sheaths The use of protective sheaths is recommended in all clinical situations where there is a risk of infection Specific sheaths are available on the market for most types of Esaote probes The sheaths listed below are produced by CIVCO Medical Instruments Inc Kalona IA USA Refer to the manufacturer s instructions for the characteristics and use of the protective sheaths See later for sheaths included in accessory kits Probes Manufacturer s Measurements Sterile Latex kit code LA332 LA424 LA435 610 001 8 9 x 61 cm Yes No A522 LA523 LA523P LA532 CA421 CA541 610 002 14 x 61 cm Yes No CA1421 CA621 CA430 CA431 CA631 BC431 CA123 C5 2 R13 Manufacturer s code Measurements Sterile Latex 610 006 Can be reduced from Yes No 11 9 to 4 6 x 61 cm 610 007 Can be reduced from No No 11 9 to 4 6 x 61 cm 610 214 3 5 x 20 cm Yes Yes 610 010 3 5 x 20 cm No Yes 610 075 2x 20 cm Yes Yes 610 039 2x 20 cm No Yes 8 4 MyLab TRANSDUCERS AND CONSUMA
73. sted also apply to the use of this probe In particular remember that The system must be properly grounded it must be supplied from a socket equipped with a protective ground connection Mobile configurations are equipped with insulated sockets to supply power without increasing the leakage current Incorrect connections or failure to use insulated sockets may compromise the electrical safety If in doubt about the protective ground connection DO NOT use the probe and contact ESAOTE immediately Characteristics and Components The IOE323 probe incorporates a high frequency linear transducer for intraoperative scanning The probe is delivered with the following accessories e Storage case e Handle attachment e Finger attachment e Sled attachment e Biopsy attachment The IOE323 probe is designed to form an angle of 45 between the head which houses the transducer and the terminal portion where the cable is connected 5 1 WARNING WARNING MyLab TRANSDUCERS AND CONSUMABLES The terminal portion of the probe has a square shape to accommodate accessories available for use with the probe offering maximum comfort during surgical ultrasonography The probe accessories are shaped in a manner to prevent rotation and to improve patient safety Probe s Transducer 4 flat facets at 90 45 angle Probe s Cable Examination Safety The intraoperative examination is to be carried out by operators who hav
74. such reactions If the protective cover is damaged during the transesophageal exam on patients affected by a spongiform encephalopathy for instance Creutzfeldt Jacob disease refer to the guidelines provided by the Centers for Disease Control and Prevention www cdc gov and by World Health Organization www who int The Operator should be familiar with the mechanical and thermal indices display and the ALARA principle As Low As Reasonably Achievable before using the probe The patient must be exposed to ultrasound for as short a time as possible and only for as long as it takes to achieve the diagnostic information During the Examination Before probe use check to be sure that the probe name shown on the monitor is correct During the examination Esaote recommended the Operator to e Never force the probe during insertion or removal 4 2 WARNING Electric scalpels used during the examination may interfere with the 2D and make it impossible to use Doppler procedures WARNING See Chapter on consumables for selecting the gel and sheathes WARNING MyLab TRANSDUCERS AND CONSUMABLES Forced insertion or removal may wound the patient Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro organisms is suspected Electric scalpels and other devices that introduce radio frequency or electro magnetic current fields into the patient interfere with u
75. time after prolonged storage periods MyLab TRANSDUCERS AND CONSUMABLES Do not immerse the entire body of the probe The probe is not waterproof and immersion may compromise the electrical safety characteristics see Appendix A for Maximum Immersion Level Extract the probe rinse it with sterile water and clean the probe handle and cable with a soft cloth dampened with a mild detergent solution Dry the probe carefully using a soft cloth or leave it to air dry for at least 30 minutes Any damage to the probe caused by substances or methods not approved by ESAOTE such as steam autoclave ethylene oxide or radiation are not covered by the guarantee These sterilization methods can permanently damage the probe For information on how to store disinfected parts refer to the locally applicable procedutes Cleaning and Sterilization of Intraoperative Laparoscopic probes and Needle Guide Kits The procedures described in this paragraph apply to the intraoperative prove and its accessories to the laparoscpic probes and all the kits used in critical applications The application is considered critical when the device comes into contact with blood or compromised tissue Sterilization 1s stipulated for this type of procedure Wearing gloves is recommended during cleaning and sterilization operations Personnel should adopt all necessary protective measures during the probe cleaning disinfection and sterilization processes ie
76. ure Mounting the ABS Intraoperative Probe Needle GUT e The ABS15 needle guide kit consists of two components one bracket to hook the needle guide to the probe handle attachment and a needle guide to attach to the bracket These two components can be disassembled to enable easier cleaning and sterilization MyLab TRANSDUCERS AND CONSUMABLES Kit assembling The ABS15 biopsy kit can only be placed on the probe handle attachment as shown below Check the integrity of the probe and needle guide and assemble the biopsy kit as follow Once the biopsy kit has been positioned on the handle attachment as shown in picture 1 insert the biopsy bracket into the grooves on the handle attachment by sliding the biopsy bracket to the end of the groove Attach the bracket with the screw provided a ee ru Choose the needle guide acceptable for the diameter of the needle to be used and insert it into the bracket Attach the needle guide to the bracket with the screw provided 7 13 MyLab TRANSDUCERS AND CONSUMABLES The needle can then be inserted into the hole formed between the bracket and the attached needle guide If necessary the needle guide attachment can be removed from the handle attachment without removing the needle To disassemble the biopsy kit reverse the previous procedure 7 14 ECG Cable Inspection WARNING Equipment CIDEX OPA is a Jobnson amp obnson Lid Re
77. with the following accessories e Storage case e Tubing kit 60 cc syringe with IV extension tubing and stopcock WARNING WARNING as ss WARNING MyLab TRANSDUCERS AND CONSUMABLES Examination Safety Endocavity probes must be used by operators who have been specially trained to insert the probe and interpret the images Carefully review current medical provisions and follow their precautions and recommendations concerning the preparation and positioning of the patient probe insertion and manipulation techniques Before the Examination Before each examination Esaote recommends the Operator to Perform a manual and visual inspection of the entire probe before using it see Chapter 2 of this manual DO NOT use the probe if it has been damaged or if you suspect damage Physical damage to the probe may cause electrical or mechanical injury to the patient Protective sheaths DO NOT provide protection against these damages nor do they guarantee that the probe is insulated electrically DO NOT USE the probe if you know or suspect that it has been damaged Use protective sheaths during the examination These sheaths are mainly composed of latex natural rubber Note The use of sterile covers is mandatory for all endocavity scans Make sure that patients who are allergic to latex are identified before each examination Serious allergic reactions to latex have been reported the Operator should be prepared to handle

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