Devicor Mammotome elite Instructions Manual Download Page 1 | Manualshive

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Devicor Mammotome elite Instructions Manual Download Page 1

Biopsy System Instructions

Please read all information carefully.
Failure to properly follow the instructions may lead to serious 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 elite is the only single-insertion, tetherless device with TruVac vacuum technology.

www.mammotome.com/ifu

eIFU number:

001212

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Summary of Contents for Mammotome elite

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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