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1. GET YOUR CUECARDS AND INNOVATIONS www myezono com Document version 2v1 01 ezono DISINFECTION AND CLEANING 1 PREPARING PROBES A CAUTION Risk of allergic reaction Some probe faces and probe sheaths contain natural rubber latex and talc which can cause allergic reactions on some individuals In rare cases some gels and disinfectants can cause an allergic reaction Read the supplied information concerning ingredients before using It is recommended to test the skin reaction before proceeding In case of incompatibility with one or more ofthe mentioned substances immediately contact a physician A CAUTION Risk of damages to the probes Probes contain very sensitive electrical components Take special care when handling them Avoid applying vibrations or mechanical pressure to the probes Do not allow sharp objects such as scalpels or knives to touch probes or cables Inspect the probe cable housing connector and face before each use Remove any dust or foreign objects from the connectors with a soft brush Check for cracks or other damage that jeopardizes the integrity of the probe Ifthe probe or its cable is damaged discontinue using it and contact eZono AG NOTE Only use probes supported by eZono AG Non supported compo nents may damage the device A WARNING Attempting to disinfect a probe using a method other than the one included here can damage the probe Non compliance will void
2. any warranty claims The level of disinfection required for a probe is dictated by the type of tis sue it will contact during use To avoid infection follow these instructions Clean the probe after each use Cleaning is an essential step prior to effective disinfection Ensure that the disinfectant type is appropriate for the probe Ensure the solution strength and duration of contact are appropriate for the intended clinical use of the probe Be sure to follow the manufacturer s instructions when using disinfect ants and to observe the expiration dates of the disinfectants 1 When using eZono probes that support the eZGuide Needle Guidance System also refer to the eZGuide Needle Guidance System user manual for more spe cific preparation instructions 10 O TABLE 1 1 OVERVIEW OF USE CASES AND DISINFECTION LEVELS USE CASE DESCRIPTION ee ECION ee NON Device contacts Cleaning and Not required CRITICAL only intact skin low level disin APPLICATION fection SEMI Device may con Cleaning and Recom CRITICAL tact mucous high level disin mended USE membranes such fection as endocavity applications CRITICAL Device contacts Cleaning and at Required USE blood compro least high level mised tissue oris disinfection used in a sterile field LEANING AND DISINFECTING PROBES WARNING Danger of electrical shocks Before starting cleaning and disinfection disconnect
3. S Ammonium GmbH L1 6 benzyl C12 16 alkyldimethyl chlorides SPORICIDIN Solu Phenol Sporicidin L3 12 NGS tion CL1 6 TABLE 1 4 OVERVIEW OF COMPATIBLE COUPLANTS PROBE BRAND TYPE INGREDIENT MANUFACTURER COMPATIBILIT RAPHASONIC Ge Propylene Glycol Rapha PHARM L3 12 NGS AQUASONIC Ge Propylene Glycol Parker L3 12 NGS 100 Laboratories CL1 6 SOFLEAN Ge Propylene Glycol TAEMEN Medi L3 12 NGS GEL cal CL1 6 CARESONIC Ge Propylene Glycol Care Mate L3 12 NGS CL1 6 ULTRA Ge Carbomer Ultragel Hun L3 12 NGS SOUND GEL gary 2000 Ltd CL1 6 DO NOT Do not allow any disinfectant to contact metal surfaces Use a soft cloth lightly dampened in a mild soap or compatible cleaning solu tion to remove any disinfectant that remains on metal surfaces WARNINGS e Refer to local regulations for environmental protection e g EPA registration or CE approval etc regarding the use of the cleaning and disinfection agents listed in table 1 2 and table 1 3 Not all of the above chemicals may have clearance for your mar ket Please verify with local authorities on approved disinfect ants in your country or region 3 USING ACOUSTIC COUPLING GELS AND PROBE SHEATHS To provide suitable acoustic coupling the used acoustic coupling gels must be compatible with the probe s material eZono AG has posi tively tested the compatibility of a gel from Aquasonics and provides a sample with the syste
4. a soft brush if necessary CLEANING OTHER PERIPHERALS Moisten a clean non abrasive cotton cloth with a mild detergent and carefully wipe clean peripheral surfaces WARNING After each cleaning or disinfection cycle and before sub sequent use it is advised to visually inspect the housing of all sup ported equipment e g probe housing and cables for signs of wear or tear or other damages 17
5. m For general use apply a liberal amount of gel between the probe and the body NOTE Follow the cleaning recommendations given in gt table 1 2 before using probe sheaths Only use medically approved sterile probe sheaths A WARNING To reduce the risk of contamination install the probe sheath only when you are ready to perform the procedure Only use probe sheaths appropriate for the sterility requirements of the proce dure Follow these steps to apply the probe sheath SY Pe RSR Place some gel inside the sheath Insert the probe into the sheath Pull the sheath over the probe until the sheath is fully extended Secure the sheath using the bands supplied with the sheath Check for and eliminate bubbles between the probe face and the sheath since they may affect the ultrasound image Inspect the sheath to ensure that there are no holes or tears before scanning 4 CLEANING EZONO 4000 The surface of eZono 4000 the probes and the accessories can be cleaned by using a recommended cleaning solution gt table 1 3 for cleaning the probes For the touchscreen it is recommended to use a 15 gt gt 16 ezono DISINFECTION AND CLEANING mild detergent or iso propyl alcohol The system casing should be cleaned with a mild detergent or ethanol WARNING Danger of electrical shocks Before cleaning the system always disconnect the AC power adapter from the system CAUTION Use only reco
6. mmended cleaners Make sure that the solu tion does not get inside the system or into the battery compartment Direct contact of electronics and battery with water or solution must be strictly avoided DO NOT Do not allow cleaning solution to leak inside the system Doing so may cause damage to internal system electronics and void the warranty cover Do not spray or pour cleaning solution directly onto the system surface Do not use chemical solvents acidic or alkali solutions or abra sive cleaners since these will damage the surface Do not use a water jet or any other high pressure cleaner Do not scratch the LCD screen Do not immerse the system or probe cable under water or other liquids CLEANING THE CASING AND THE LCD SCREEN Moisten a clean non abrasive cotton cloth with a cleaning solution and wipe the casing and screen clean Apply the cleaner to the cloth rather than the surface of the screen CLEANING PROBES Probes must be cleaned after every use Cleaning is a necessary step before disinfection thus cleaning and disinfecting activities for probes are described in gt chapter 2 CLEANING PRINTER AND ISOLATION TRANSFORMER To clean the printer or the isolation transformer please refer to the respective user manuals for detailed cleaning instructions CLEANING THE AIR VENTS It is recommended to verify that the air vents are free from dust dirt or other obstacles Clean them with
7. owing the manufacturer s instructions for the duration of the immersion 7 Air dry or towel dry with a clean disinfected cloth wipe method OR Rinse in disinfected water to the point of the previous immersion and then air dry or towel dry with a clean disinfected cloth immersion method 8 Examine the probe and cable for damage such as cracks splitting or fluid leaks PROBE CABLE PROBE BEND RELIEF CABLE SLEEVE PROBE HANDLE PROBE NOSE PROBE HEAD PROBE FACE ZERO INSERTION FORCE CONNECTOR INGRESS OF LIQUIDS CLASSIFICATION IPX7 IMMERSIBLE FOR lt 30 MINUTES Wroaunkwn ILLUSTR 1 1 PROBE COMPONENTS If any damage at the probe is evident discontinue using the probe and contact eZono AG To avoid damages to the probe consider the following guidelines Using non recommended cleaning solutions and disinfectants incor rect solution strengths or immersing a probe deeper or for a longer contact time can damage or discolour the probe and will void the probe warranty Ifyou use an isopropyl alcohol solution for disinfection ensure the 12 solution is only 70 alcohol or less Solutions of more than 70 alcohol can cause product damage TABLE 1 2 OVERVIEW OF COMPATIBLE DISINFECTANTS PROBE SOLOMON TYPE INGREDIENT MANUFACTURER COMPATIBILIT CIDEX OPA Solution Ortho Johnson amp L3 12 NGS ph
8. thalaldehyde Johnson CL1 6 CIDEX PLUS Solution Glutaraldehyde Johnson amp L3 12 NGS Johnson CL1 6 GIGASEPTFF Solution Ethanol Sch lke amp Mavr L3 12 NGS Succindialde UK Ltd CL1 6 hyde VIRKON Solution Potassium Dupont Antec L3 12 NGS CL1 6 WAVICIDE 01 Solution Glutaraldehyde Medical Chemi L3 12 NGS cal Corporation CL1 6 AIDAL PLUS Solution Glutaraldehyde Whiteley Corp L3 12 NGS CL1 6 CETYLCIDE G Solution Glutaraldehyde Cetylite Indus L3 12 NGS tries CL1 6 TABLE 1 3 OVERVIEW OF COMPATIBLE PRE CLEANERS PROBE BRAND NAME TYPE INGREDIENT MANUFACTURER CHEMICAG j Y ENZOL Solu Subtilisin Johnson and L3 12 NGS tion proteolytic Johnson CL1 6 enzymes TRANSEPTIC Spray Isopropyl Parker L3 12 NGS alcohol Laboratories CL1 6 SSN Solu Isopropyl Burnishine L3 12 NGS THERACIDE tion alcohol Products CL1 6 PLUS T SPRAY II Spray Alkyl dimethyl Pharmaceutical L3 12 NGS benzyl Innovations Inc CL1 6 ammonium chloride 13 14 SINFECTION AND CLEANING TABLE 1 3 OVERVIEW OF COMPATIBLE PRE CLEANERS PROBE BRAND NAME TYPE INGREDIENT MANUFACTURER CHEMICAL iig Y SANI CLOTH Wipe Isopropyl Nice Pak L3 12 NGS PLUS Alcohol CL1 6 SEPTIHOL Solu Isopropyl STERIS L3 12 NGS tion Alcohol CL1 6 ENDOZIME Solu 2 Propanol Ruhof L3 12 NGS tion CL1 6 CLEANISEPT Wipe Quaternary Dr Schumacher L3 12 NG
9. the probe from the system Never place the device on the floor when cleaning and dis infecting the probe The cable connection to the device must always be higher than the lowest point of the cable to prevent fluid from flow ing down the cable to the device WARNING To avoid injury always use protective eyewear and gloves when cleaning and disinfecting a probe To disinfect a probe you can choose between an immersion method or a wipe method using the corresponding disinfection agent recom mended by eZono AG gt table 1 2 NOTE Probes can be disinfected using the wipe method only if the manufacturer s instructions of the compatible disinfectant you are using indicates it can be used with a wipe method 1 Disconnect the probe from the system 2 Remove any probe sheath 3 Damp lightly a soft cloth in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids from the probe or cable 11 FA ezono DISINFECTION AND CLEANING TZ NOTE Apply the solution to the cloth rather than the surface 4 Rinse with water or wipe with water dampened cloth then wipe with a dry cloth 5 Mix the disinfection agent following the manufacturer s instructions for solution strengths and contact duration 6 Wipe the probe s surfaces with the disinfection agent OR Immerse the probe into the disinfection agent not beyond the cable sleeve gt illustration 1 1 foll

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