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Reprocessing Information
•
Open the instrument's handles wide (2).
•
Hold the top part of the protective housing (1) in one hand and use the other hand to grab the bottom part.
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Now pull the top and bottom parts apart.
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Lift the blade (3) out of the lock-in position (4) by bending it slightly upwards, and then pull it backwards and out of the instrument.
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Dispose of the blade according to the applicable regulations.
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Remove the blade if it has not already been removed in the operating room.
•
Immerse into cold water for 5 min.
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Use the cleaning tools provided for this purpose to clean the slit in the electrode.
acc. to DIN EN ISO 17664 This document does not replace the instructions for use!
Designation Item number (REF)
marClamp CUT IQ 80-632-00-04 to 80-632-50-04 Danger of injury and risk of damage to the bipolar sealing instrument marClamp CUT IQ from improper handling!
WARNING
Reprocessing limitations
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Never reprocess and/or reuse blades!
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Do not perform any quick sterilization without a drying phase or hot air sterilization!
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Perform a function check before sterilization and before usage!
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The instruments may be used only with the maxium® electrosurgery unit produced by Gebrüder Martin. Hardware version HW 06 or higher is required (IQ connector = coded special connector)!
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When changing the blade, insert it into the handle with care in order to avoid damage to the blade!
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Do not touch any hard objects during the function check with the newly inserted blade! There is risk of damage to the blade!
Preparation for cleaning
Damage, loss of cable insulation, damaged or scratched contact surfaces with adherent residues of tissue, functional impairment due to decreasing compression force in the jaw part, loosening or wear of components. With every application, the wear of the instrument progresses. Reliable functioning of the instrument is guaranteed for the first 50 application cycles at an average usage frequency and load. Gebrüder Martin recommends replacing the instrument when this number is exceeded.
Workplace
CSSD, instrument processing department
Storage and Transport
Handle with great care. Do not drop or throw. Do not bend the cable. Do not store or transport cables together with cutting instruments. Store and transport in safe containers/packages.
Manual pre-cleaning (in preparation for machine cleaning)
Insert the accompanying cleaning brush through the blade guideway in the joint and clean by repeatedly pulling the brush back and forth. •
Brush the electrode with a suitable soft brush.
•
Brush all contaminated parts with a suitable brush while moving all the movable parts.
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Clean in ultrasonicator for 5 min at 40°C (104°F) with 0.5% working solution of an alkaline cleaning agent.
Use of hydrogen peroxide can lead to premature wear of the instrument and thus reduce its lifetime.
Date of Release: 2016-12 · 90-016-52-10 · Printed in Germany · Copyright by Gebrüder Martin GmbH & Co. KG · Alle Rechte vorbehalten · Technische Änderungen vorbehalten · We reserve the right to make alterations · Cambios técnicos reservados · Sous réserve de modifications techniques · Ci riserviamo il diritto di modifiche tecniche · Revision: 1
Place the marClamp CUT IQ in the RDG load carrier •
Insert the instrument only when the protective housing is open.
Recommendation for machine cleaning (sample validation in accordance with ISO 15883 and accompanying information in accordance with DIN EN ISO 17664). Deviating parameters are possible, validated in accordance with ISO 15883: Phase
Step
Temperature
T (min)
Water quality
Chemicals
1
Pre-cleaning
Cold water max. 40°C (104°F)
4
Drinking water
--
2
Cleaning
55°C (131°F),
5
Fully demineralized water if possible
pH-neutral or alkaline, e.g.
max. 65°C (149°F)
neodisher® MediZym neodisher® MediClean neodisher® MediClean forte
Machine Cleaning
Working solution 0.5 % 3
Interim rinsing
> 10°C (50°F)
2
Fully demineralized water if possible
--
4
Thermal disinfection
For example 90 AO 3000, see ISO 15883
5
Fully demineralized water if possible
--
Drying
--
According to program
--
--
5
Maintenance
Lightly spray the joint areas and mechanisms in the handle with an instrument care agent.
Inspection and Functional Check
Check instrument for damage prior to each use. Test the mechanism only after the blade has been inserted and only in the sterile operating area.
Packaging
Use approved sterilization packing (e.g. according to EN 868, ISO 11607) or sterilization containers. Steam sterilization and sterilization when fully assembled.
Sterilization
Sterilization in a sterilizer in accordance with EN 285 and validated in accordance with ISO 17665. The temperature must be at least 132°C (270°F) with a holding time of 3 min., and must not exceed 137°C (278°F) and a holding time of 18 min.
Additional information
Blades are single-use items. Spare blades (REF 80-632-00-04) are supplied in sterile condition and may be inserted only after sterilization of the marClamp CUT IQ and only in the sterile operating area.
Manufacturer’s contact details
Gebrüder Martin GmbH Co. KG, D-78532 Tuttlingen, Tel. +49 7461 706-0
Designation
Image
Instrument
Instrument care agents or surface tension-reducing agents can be added if they are approved for the medical instruments and are a part of the validated program.
Blade (single-use item, sterile)
After this procedure, all parts should be checked for visible dirt. If there is any residual dirt, repeat the process. After each application and before re-sterilization, one indicator must be removed from the cycle counter. Use a ballpoint pen or a similar object for removal. You can break the indicator out by pressing the ballpoint pen against it.
Machine Cleaning
Cleaning tool
Cleaning brush
Gebrüder Martin GmbH & Co. KG A KLS Martin business KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax 706-193 [email protected] · www.klsmartin.com
Date of Release: 2016-12 · 90-016-52-10 · Printed in Germany · Copyright by Gebrüder Martin GmbH & Co. KG · Alle Rechte vorbehalten · Technische Änderungen vorbehalten · We reserve the right to make alterations · Cambios técnicos reservados · Sous réserve de modifications techniques · Ci riserviamo il diritto di modifiche tecniche · Revision: 1