Applicators and Probe •CE0124
Contents
1. 30150 001 Manufacturer ERBE Elektromedizin GmbH Waldhornlestr 17 72072 Tubingen Germany P O Box 14 20 72004 Tubingen Germany Tel 49 70 71 755 0 Fax 49 70 71 755 179 Email support erbe med de Distributed by USA Territory ERBE USA Inc 2225 Northwest Parkway Marietta GA 30067 Customer Support 800 778 ERBE 3723 Tel 770 955 4400 Email sales erbe usa com 07 10 Printed in Germany ERBE Elektromedizin GmbH 20139 174 20139 178 20139 181 20139 185 20139 186 20150 220 20150 225 20150 226 20150 230 20150 231 20150 238 20150 239 20150 241 Single use only Sterility not guaranteed if package has been opened or damaged Discard if packagage is damaged STERILE Applicators and Probe IMPORTANT Please read all information carefully These notes on use do not replace the user manual of the Water Jet System used Read the user manual of the Water Jet System and ask ERBE or your distributor in case of doubt Caution Federal law USA restricts this device to sale by or on the order of a physician Purpose The applicators and probe are used with designated Water Jet Units for the cutting and dissection of soft tissue in clinical appli cations as outline in the intended use of the Water jet Units Intended Use The applicators and probe are intended for use with the following designated ERBE Equipment For further information see User Manual of the specific E2. RBE equipment e Applicators for ERBE Helix Hydro Jet Applicators with Art No 20139 xxx Note Only ERBE Fluid cartridge Art No 20139 083 is to be used in conjunction with these appli cators e Applicators and Probe for ERBEJET 2 Accessories with Art No 20150 xxx Note Only ERBE Pump cartridge Art No 20150 300 is to be used in conjunction with these accessories Applicators for the ERBE Helix Hydro Jet that have a suction hose with suction can be connected to the suction of the Helix Hydro Jet Applicators for the ERBEJET 2 that have a suction hose with suction can be connected to the suction module Model ESM 2 Note Alternate suction devices can be used but the suction vacuum pressure should not exceed 11 6 psi 800 mbar Safety Instructions WARNING This product may only be used by medical personnel who have been trained per these instructions Before use check that the product is intact Verify that there are no signs of physical damage If damaged do not use this product When using and handling the product the involved medical staff should wear personal protective equipment e g gown faceshield or eye protection mask gloves etc to minimize the risk of exposure to infectious agents due to undesirable unex pected spraying or splashing mishandling of the contaminated accessory etc When using an applicator with suction maintain adequate and constant suction as necessary as well as m
3. onitor the suction tubing to minimize the possibility of blockage Never lay this product on the patient or in his her direct vicinity Protect this product from any form of mechanical damage Do not throw Do not use force ERBE recommends that the product not be reprocessed after use High temperatures in particular e g in the autoclave can affect material properties and product function making its Intend ed Use no longer possible ERBE Elektromedizin expressly warns against modifying the product Any modification exempts ERBE Elektromedizin from any and all liability 82014 008 How to Use Check the expiration date An expiration date is printed on the packaging of the product Do not use any product beyond its expiration date Control and open packaging Use this product only if the packaging has not been opened or damaged If the packaging is open or damaged the product is no longer sterile and must not be used In this case throw the product away Use aseptic techniques when removing the product from the packaging Connecting the product To connect the applicators or probe please read the relevant section in the following designated ERBE equipment User Man ual e For applicators with Art No 20139 xxx ERBE Helix Hydro Jet User Manual e For applicators and probe with Art No 20150 xxx ERBEJET 2 User Manual Note The probe connects and is used like an applicator
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