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MEH1, MEP10, MEP13

CEpartner4U BV
Esdoornlaan 13

3951 DB Maarn, NL
www.CEpartner4U.com

Certificate holder (Brazilian representative company):

Imex Medical Comércio e Locação LTDA

Rua das Embaúbas, 601 – Fazenda Santo Antônio – São

José – Santa Catarina – Brasil

CEP: 88.104-561 – Tel.: +55 48 3251-8800

Technical Manager:

Aline da Silva Gullo - CRF-SC 7774

Telefone: 0800 709 3771

E-mail: [email protected]

Mammotome and Mammotome elite are registered trademarks of Devicor Medical Products, Inc. in the

USA and optionally in other countries. TruVac is a trademark of Devicor Medical Products, Inc. in the

USA and optionally in other countries.

Devicor Medical Products, Inc.

300 E-Business Way, Fifth Floor

Cincinnati, OH 45241 USA

AW001212 REV D

Содержание Mammotome elite

Страница 1: ...erious surgical consequences IMPORTANT This package insert is designed to provide instructions for use of the Mammotome elite Holster and Probe It is not a reference to surgical techniques Mammotome e...

Страница 2: ...sion the Mammotome elite Biopsy System may also be used to partially remove such palpable lesions Whenever breast tissue is removed histological evaluation of the tissue is the standard of care When t...

Страница 3: ...vacuum inside the device to assist in pulling tissue into the Probe aperture while the sharpened inner cutter rotates at high speeds and advances across the aperture to acquire targeted tissue The tis...

Страница 4: ...ection As with any biopsy instrument there may be a potential for infection Physicians should use sound judgement for use of this device with patients where increased risk or complications may be asso...

Страница 5: ...ury illness or death of the patient Precautions Minimally invasive procedures should be performed only by persons having adequate training and familiarity with minimally invasive techniques Consult me...

Страница 6: ...leeding disorders may be at increased risk Use of products manufactured or distributed by companies not authorized by Devicor Medical Products Inc may not be compatible with the Mammotome elite System...

Страница 7: ...ipment as necessary DIRECTIONS FOR USE Route of Administration Method of Application Caution Federal USA law restricts this device to sale by or on the order of a physician This instrument should only...

Страница 8: ...ately 200 minutes to fully charge IMPORTANT The Holster MUST BE FULLY CHARGED before the initial use Loading the Probe 1 Using sterile technique remove the Probe from the package To avoid damage do no...

Страница 9: ...his time If the Holster is left undisturbed for 10 minutes after loading a Probe the Holster will enter a sleep mode to conserve battery charge During sleep mode the Biopsy and Battery Indicator Light...

Страница 10: ...vation of the sampling cycle only when the active sample button is pressed Procedures for Tissue Sampling Prepare the percutaneous site in accordance with standard surgical technique prior to insertio...

Страница 11: ...hould be used as appropriate Keep fingers clear of active Biopsy Button until target site has been reached 9 Push the active Biopsy Button on the Holster to acquire a tissue sample The biopsy cycle pr...

Страница 12: ...or the next sample acquisition and repeat step 6 as necessary to obtain additional samples To avoid bending the needle do not apply excessive pressure when positioning within the breast or axilla Veri...

Страница 13: ...r clockwise a quarter turn See Illustration 8 Step 1 Remove the Cap and Tissue Basket together See Illustration 8 Step 2 Press the Tissue Basket Release Button to remove the Tissue Basket from the Spe...

Страница 14: ...ner Illustration 10 CAUTION Probe is meant for SINGLE USE ONLY Dispose of Probe immediately after use CAUTION Do not recap Probe tip The cleaning agents and disinfectants specified for use in these in...

Страница 15: ...e crevices wipe thoroughly using a clean soft bristle standard toothbrush moistened with lukewarm 27 C 44 C tap water 5 Dry with a clean soft cloth Do not expose to heat greater than 50 C 6 Inspect th...

Страница 16: ...n soft bristle standard toothbrush moistened with purified water should be used to remove the disinfectant from the crevices of the device Repeat 6 additional times to thoroughly remove residue 6 Wipe...

Страница 17: ...attery will require approximately 200 minutes to fully charge 6 The Battery Indicator Light will flash yellow or green to indicate active charging and level of charge while on the charging base The Ho...

Страница 18: ...OTE To minimize unnecessary power usage during extended periods of non use the Holster charger can be unplugged NOTE Do not stack charging base on top of any other devices Troubleshooting 1 The Fault...

Страница 19: ...presentative Holster Specifications Electrical Conformity This medical equipment has passed all required testing for electric shock fire and mechanical hazards in accordance with UL 60601 1 IEC EN 606...

Страница 20: ...Carton EPE Foam Environmental Conditions Fully Loaded carton with product 3lb 1 5oz EPE Foam 5 7oz B Flute Corrugate Carton with Label 10 4oz Paper IFU Set Up Sheet 4 0oz Charger 14 1oz Holster 8 6oz...

Страница 21: ...s declaration electromagnetic emissions The Mammotome elite Biopsy System is intended for use in electromagnetic environments specified below The customer or user of the Mammotome elite Biopsy System...

Страница 22: ...s used for domestic purposes Surge IEC 61000 4 5 0 5 KV 1 KV 2KV line to ground PASS Power Frequency Magnetic Field IEC 61000 4 8 30A m 50 and 60Hz PASS The power frequency magnetic field should be of...

Страница 23: ...e elite Biopsy System The Mammotome elite Biopsy System is intended for use in electromagnetic environments in which radiated RF disturbances are controlled The customer or user of the Mammotome elite...

Страница 24: ...de 1 your account name and number 2 your contact information and 3 your question Once received a member of the Customer Support Team will reply within one business day Requesting a Paper Copy of the I...

Страница 25: ...a way so as to in Devicor Medical Products Inc s judgment affect its stability or reliability 3 subjected to improper use negligence or accident or 4 used other than in accordance with the design and...

Страница 26: ...IAL DAMAGES INCLUDING WITHOUT LIMITATION DAMAGES RESULTING FROM LOSS OF USE PROFITS BUSINESS OR GOODWILL OTHER THAN AS EXPRESSLY PROVIDED BY A SPECIFIC LAW Devicor Medical Products Inc neither assumes...

Страница 27: ...Technical Manager Aline da Silva Gullo CRF SC 7774 Telefone 0800 709 3771 E mail qualidade imexmedicalgroup com br Mammotome and Mammotome elite are registered trademarks of Devicor Medical Products I...

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