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Page 1
Bipolar Sealing System marClamp® CUT IQ
Instructions for Use
EN V. 1.1 (2015-06) 90-017-52-11
Enclosure Reprocessing Information acc. to EN ISO 17664
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Symbol Explanation Follow Instructions for Use
Reference number for ordering Gebrüder Martin products (item number) Lot designation Not to be reused!
Store in a place protected from direct sunlight
Store in a dry place
Do not use if packaging is damaged
Use before Not to be re-sterilized!
Information on minimum and maximum temperature for storage and transportation. See section 1.7 “Storage and Transportation”, page 9 for valid values. Information on minimum and maximum atmospheric humidity for storage and transportation. See section 1.7 “Storage and Transportation”, page 9 for valid values. Manufacturer CE marking of conformity
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
Contents Terms & Acronyms ... 5 1
Product Liability and Warranty ... 6
1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8
General Information ... 6 Scope of Delivery ... 6 Intended Purpose ... 6 Technical Product Description ... 7 Warranty ... 8 User’s Inspection ... 9 Storage and Transportation ... 9 Hotline... 10
2
Notices Concerning this Document... 11
2.1
Symbols Used in this Document ... 11
3
Safety Notes ... 12
4
Application ... 15
4.1 4.2
Overview ... 15 Connection to the Electrosurgery Unit maxium® ... 16
4.2.1
Procedure with the SealSafe® IQ ...16
4.3
Sealing ... 17
5
Processing, Cleaning, Disinfection and Sterilization ... 20
5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8
General Information ... 20 Preparation for Cleaning ... 22 Manual Pre-Cleaning of the Jaw Part ... 23 Machine Cleaning ... 24 Cycle Counter ... 25 Sterilization ... 26 Inserting the Sterile Blade ... 27 Functional Check ... 29
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Ecological Information ... 31
6.1 6.2 6.3
Disposal of Packing ... 31 Return Shipment ... 31 Disposal of the Device ... 31
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Terms & Acronyms Designation
Description
CJD
Creutzfeldt Jakob Disease
G1–G5
Gradation levels for power setting
HF
High Frequency
HW
Hardware version
NTP
Low temperature plasma sterilization
PU
Packaging unit
RDG
Cleaning and disinfection device
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
1
Product Liability and Warranty
1.1
General Information
We thank you for having decided to buy one of our products. This product bears the CE-marking, which means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices. We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 [email protected] · www.klsmartin.com
1.2
Scope of Delivery
Illustration
Description
REF
marClamp® CUT IQ, 18 cm, with integrated connecting cable
80-632-18-04
Cleaning tool
80-630-58-04
Cleaning brushes (3 pcs)
80-632-01-04
Instructions for Use Reprocessing Information Order separately Blade (single-use item, sterile), PU = 10 pcs
1.3
80-632-00-04
Intended Purpose
The marClamp® CUT IQ bipolar sealing system is intended for the permanent sealing of veins, arteries and tissue bundles, with subsequent dissection of the sealed tissue using the same instrument. It is designed for use in open-surgery applications.
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
1.4
Technical Product Description
The bipolar sealing instrument marClamp® CUT IQ is intended for use with the electrosurgery unit maxium® (type ME 402) from hardware version HW 06 and software version V3.412, or new developments by Gebrüder Martin. Use its connection cable to connect it to the corresponding bipolar output. The current “SealSafe® IQ” will be assigned automatically. It can be used only with this type of instruments, too (Plug & Play)! The interaction of mechanical pressure (p) and coagulation induced by high-frequency current (I) creates a reliably and permanently sealed zone on arteries, veins and tissue bundles. It is imperative that the pressure be constantly maintained throughout the entire application period.
Permanent occlusion is possible for vessels up to 7 mm in diameter. Placing two seals side by side is recommended for larger vessels. The integrated blade can then be used to cut this in the middle. The instrument’s maximum sealing length is 18 mm, of which approx. 16 mm are cut. The maxium® electrosurgery unit offers a bipolar coagulation current for the sealing of tissue and tissue layers that is specifically designed for sealing instruments. Gebrüder Martin guarantees a minimum of 50 reprocessing cycles. The instrument is equipped with a cycle counter for this purpose (see section 5.5 “Cycle Counter”, page 25), which allows you to indicate the number of reprocessing cycles already completed. With every application, the wear of the instrument progresses. At average application frequency and load, the safe functioning of the instrument is guaranteed for 50 cycles. Gebrüder Martin recommends that you stop using the instrument after this time has expired, and replace it, to ensure safe and secure operation.
NOTICE Please note the information about the “Sealing using SealSafe® IQ” method and the description of the “SealSafe® IQ” current type in the instructions for use of the maxium® electrosurgery unit. The maximum permissible HF voltage is 300 Vp.
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
WARNING Danger of injuries from insufficient qualification of the operator! Safe use of the marClamp® CUT IQ in combination with the SealSafe® IQ current type requires the user to be familiar with the technology and application modes of electrosurgery. Electrosurgical instruments may be used only by persons specially trained or instructed in their use!
NOTICE Read the Instructions for Use of the maxium® electrosurgery unit for its correct use/ configuration.
CAUTION Risk of injury from improper application or misuse! Tubal ligation with the marClamp® CUT IQ is not a safe method of contraception!
1.5
Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements diverging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. The blades are designed as sterile disposable items. The warranty for the blades expires after their one-time use. Sterile packages with broken seal are non-returnable. Important Notices The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by Gebrüder Martin to perform such work. If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the operator of the product is required to obtain from the repairer a certificate with details about the nature and scope of the repair work done. This certificate must show the date of the repair and the details of the person or firm carrying out the work and must be signed. In all cases where a party other than the product manufacturer performed the work, repaired products must be additionally marked with the repairer’s ID label. Improper interventions or alterations performed by third parties during the period of limitation shall void any and all warranty claims. Performing unauthorized actions on the product is strictly prohibited at any time. Non-compliance will void any liability claim against Gebrüder Martin. 8
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
1.6 •
•
User’s Inspection
Check the shipment immediately upon receipt: -
Original packaging and packing seals are intact.
-
The contents are complete and undamaged.
Report any transport damage immediately.
The following additional points must be noted here: •
Visual inspection of the cable and plug for potential damage.
•
Intactness of the handle (check for cracks, fractures or deformation).
•
Easy movement of all components.
1.7
Storage and Transportation
Information on minimum and maximum temperature for storage and transportation: Designation
Environmental conditions for transport and storage
marClamp® CUT IQ Ambient temperature Relative humidity (no condensing moisture!)
+10 °C (50 °F) to +30 °C (86 °F) 30–65%
•
Store instruments in a clean, cool and dry place.
•
Protect against direct sunlight.
•
Protect instruments against mechanical damage.
•
Store and transport instruments in safe containers/packing. Use certified sterilization packing (e.g. according to EN 868, ISO 11607) or sterilization containers for sterilization.
•
Handle instruments with great care. Do not drop or throw.
•
Do not store or transport cables together with cutting instruments.
•
Protect sterile-packaged blades from direct sunlight. Storage in the original packaging up to the first use is recommended.
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
1.8 •
•
Hotline
Should you have any questions on how to handle the product or use it for clinical applications, please do not hesitate to contact the Product Management: Tel:
+49 7461 706-243
Fax:
+49 7461 706-190
For technical questions and questions about maintenance contracts and training, please contact our Martin Service Center: Tel:
+49 7461 706-343
Fax:
+49 7461 706-408
E-mail: [email protected]
NOTICE Each product and its packaging are usually marked with a specific lot number (LOT) and a reference number (REF). Please always indicate LOT and REF in case of a complaint.
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Notices Concerning this Document
Non-observance of this document can lead to serious patient injury! Improper handling and care as well as non-intended use can lead to premature wear and/or pose a risk to patients and users! It is the operator’s responsibility to ensure that all personnel handling the product have understood and do observe the notes and instructions in this document. •
Every user is required to read this document completely and follow it carefully.
•
In particular, be sure to heed all cautions, warnings and danger notices.
•
Keep this document accessible to users at all times.
•
Please also observe the Instructions for Use of the electrosurgery unit maxium®. In particular the safety notes therein must always be observed!
2.1
Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words:
WARNING Life hazard or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!
CAUTION Risk of injury! Indicates a situation which, if not avoided, could result in minor or moderate injury!
NOTICE Risk of material damage! Indicates a situation which, if not avoided, could lead to material damage (loss of time, data loss, device/machine failure, etc.)!
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
3
Safety Notes
WARNING Non-observance of this document can lead to serious or even lethal patient injury!
WARNING Risk of explosion and fire from highly flammable gases! Do not use any flammable anesthetic gases or oxidizing gases in connection with the bipolar sealing system marClamp® CUT IQ. •
Before beginning the sealing process, make sure there are no endogenous gases in the application area.
WARNING Risk of burns upon contact of the electrodes with metallic parts! Upon contact of the electrodes with metallic parts, shunts for the HF current or concentrated leakage current paths can form. These can cause burns. •
Never touch other metallic objects when activating the current!
WARNING Risk of electromagnetic interference in case of active implants! In case of patients with cardiac pacemakers or other active implants, there is always the danger of interference with or damage to the active implants. •
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Consult a cardiologist and the manufacturer of the pacemaker or active implant before the operation!
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
WARNING Risk of burns from unintended contact to the patient's tissue! Unintended HF activation, e.g. by the foot switch, can lead to burns and electrical shocks if the electrosurgery instrument is deposited on the patient and thus comes into contact with tissue! •
Do not deposit temporarily unused instruments on the patient during the intervals between applications! Instruments should be deposited away from the patient, e.g. on an instrument table!
•
Never seal unless the jaw part of the instrument is visible! Unintended activation or moving of the instrument can lead to patient injury!
•
Never touch other metallic objects during the sealing process!
•
Always make sure the instruments do not come into accidental contact with tissue or other low-resistance materials (e.g. liquids)!
WARNING Risk of burns due to hot surfaces! As a result of heat conduction, the electrodes in the jaw part and the outer surfaces of the jaw part remain very hot even after the sealing process has been completed, so they can cause accidental burns. •
Avoid touching the jaw part and contact with tissue immediately after the sealing process!
WARNING Risk of infection in case of non-sterile usage! •
Remove and dispose of the blade after each usage.
•
Never reprocess and/or reuse blades!
CAUTION Risk of injury when inserting the blade! •
Avoid contact with the cutting edge!
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
CAUTION Risk of injury for patient and user from improper use! Improper application or misuse can cause severe injuries to the patient and operator and/or lead to premature wear of the sealing system! •
Clean and sterilize marClamp® CUT IQ before each application, see section 5 “Processing, Cleaning, Disinfection and Sterilization”, page 20.
•
A functional check must be carried out before each application, see section 5.8 “Functional Check”, page 29!
•
Lay out the connecting cable in such a way that it touches neither the patient nor other cables. Protect the connecting cable against mechanical damage (squashing by trolley castors, squeezing, kinking, etc.)!
•
There can be interference with other devices due to the use of high frequency devices!
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4
Application
•
Please note the safety instructions, see section 3 “Safety Notes”, page 12.
•
Sterilize marClamp® CUT IQ before first use, see section 5 “Processing, Cleaning, Disinfection and Sterilization”, page 20.!
•
Products that are packed in sterile packing can be taken out of their packing and applied immediately without further pre-treatment.
•
A functional check must be carried out before each application, see section 5.8 “Functional Check”, page 29!
4.1
Overview 1 Jaw part 2 Protective housing 3 Handle 4 Blade 5 Blade trigger 6 Switch 7 Connection cable
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
4.2
Connection to the Electrosurgery Unit maxium®
NOTICE The bipolar sealing instrument marClamp® CUT IQ with sterile blades is intended for use with the electrosurgery unit maxium® (type ME 402) from hardware version HW 06 and software version V3.412, or new developments of Gebrüder Martin. Use its connection cable to connect it to the corresponding bipolar output. The current “SealSafe® IQ” will be assigned automatically.
NOTICE Read the Instructions for Use of the maxium® electrosurgery unit for its correct use and configuration. The maximum permissible HF voltage is 300 Vp.
4.2.1
Procedure with the SealSafe® IQ
After inserting the instrument connector, the maxium® automatically delivers the required SealSafe® IQ current type to the inserted marClamp® CUT IQ with the G3 factory default settings. For this purpose, both bipolar outlet sockets of the maxium® can be used. The power setting is selected in gradation levels (G levels G1–G5). The switch-off impedance and sealing time increase with increasing G level. If a footswitch is desired for activating the sealing current, this switch must be selected separately.
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4.3
Sealing
•
Bring the jaw part (1) to an ergonomically optimal position.
•
Then grasp the tissue to be treated with the jaw part (1), inserting the tissue only so far into the jaw part that it does not proximally protrude beyond the electrodes.
•
Close the handle (2) until the sealing current is triggered by the switch integrated in the handle.
•
The maxium® finishes the sealing process automatically and confirms this acoustically. This shuts down the current automatically before carbonization of the tissue can occur.
WARNING Risk of infection in case of non-sterile handling! Non-sterile use and improper sterilization can cause severe health risks for the patient! •
Sterility of the blades can be guaranteed only if the packaging is undamaged and the seal intact.
•
Do not use after the expiration date indicated on the packaging.
•
Remove the blades following each application.
•
Dispose of used blades!
•
Never reprocess and/or reuse blades!
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
•
Moving the blade trigger (3) pushes the blade through the joint area of the handle and the jaw part (1) of the marClamp® CUT IQ and cuts the sealed tissue, see also section 4.1 “Overview”, page 15.
WARNING Risk of burns or tissue damage from operating errors! •
Before starting the sealing process, verify that you have grasped the correct structures in order to prevent inadvertent capture of healthy structures such as ureter, nerve tracts, intestinal loops, etc.!
•
Permanent occlusion is possible for vessels up to 7 mm in diameter. Placing two seals side by side is recommended for larger vessels. The integrated blade can then be used to cut this in the middle. The instrument’s maximum sealing length is 18 mm, of which approx. 16 mm are cut.
•
Ensure that the tissue structures to be sealed are not too thin. For the sealing process, the amount of tissue must sufficiently fill the space between the electrodes after locking them!
WARNING Risk of burns due to high current concentration! •
Begin with a low power setting and increase setting if required.
•
Determine the cause if no or only a poor sealing effect is achieved. Do not increase power settings up to the maximum without prior examination of the situation!
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
WARNING Danger of bleeding in case of improper application! •
Never engage the blade trigger during vessel sealing! The blade must be retracted into the marClamp® CUT IQ; otherwise it will cause a short circuit, and no sealing will occur.
•
Do not cut grasped tissue with the blade before completion of the sealing process! Danger of bleeding!
•
Perform cut only after the maxium® unit has properly signaled the end of the sealing process!
•
Safe vessel sealing is not guaranteed when the instrument’s jaws are immersed into electrically conductive liquids, due to resulting current conduction (shunt circuit)!
•
Tissue particles can be caught in the electrodes, the blade guideway and the joints. Such incrustations can impair the instrument’s proper functioning (due to electric shunts or blade jamming). Use the supplied cleaning tool, a brush or swab and sterile water to clean the instrument.
WARNING Risk of burns due to hot surfaces! As a result of heat conduction, the electrodes in the jaw part and the outer surfaces of the jaw part remain very hot even after the sealing process has been completed, so they can cause accidental burns. •
Avoid contact with the jaw part and contact to tissue right after the sealing process!
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Instructions for Use Bipolar Sealing System marClamp® CUT IQ
5
Processing, Cleaning, Disinfection and Sterilization
5.1
General Information
NOTICE The operator/user is responsible for cleaning, disinfecting and sterilizing the instrument. It is essential that national regulations and restrictions be observed. Use appropriate and approved sterilization packing (e.g. in accordance with EN 868, ISO 11607) for sterilization, subsequent transport and storage. Reprocessing instructions acc. to EN ISO 17664 are attached in the form of a separate sheet intended to be displayed in your instrument processing department. The parameters for cleaning and disinfecting the product are to be determined by the operator/user, e. g. as part of the hygiene plan. The treatment agents must be selected to be compatible with the component materials as well as hygienically and microbiologically effective. A thorough final rinse must be performed to ensure that no residues are left on any of the individual components after reprocessing.
NOTICE •
Observe all applicable national regulations in regard to reprocessing of the products in case of patients suffering from Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of the disease.
•
Note that successful reprocessing of this medical product can be guaranteed only after prior validation of the reprocessing process. The responsibility for this lies with the operator/reprocessor.
•
In the interest of process capability and better and more reliable cleaning results, machine reprocessing should always be preferred to manual cleaning, unless they have to be combined.
•
Due to process tolerance, the data provided by the manufacturer serve only as reference values for the evaluation of the reprocessing processes carried out by the operator/ reprocessor.
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