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Related Manuals for Ovesco remOVE DC Impulse
Summary of Contents for Ovesco remOVE DC Impulse
- Page 1 Instructions for use English Ref. No. 400.01 remOVE DC IMPULSE...
- Page 2 DC Impulse Instructions for use Revision 08 Date 2019-04-24 For remOVE DC Impulse Version 2.XX Ref No.: 400.01 Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 72076 Tuebingen Germany +49 7071 98979 160 service@ovesco.com www.ovesco.com...
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Page 3: Table Of Contents
Contents About this document ................4 Components ..................5 Accessories / replacement parts ............6 Description ...................6 Intended use / indication ..............7 Contraindications .................8 Complications ..................8 Warnings / precautions.................9 Components and products required for use ........11 Preparation ..................12 Use of product ..................14 Mode of operation ................ -
Page 4: About This Document
Unauthorized opening or perfor- mance of services by any non-authorized person or persons voids the warranty and the manufacturer’s liability with regards to operational safety. 4 / 32 Instructions for use remOVE DC Impulse 400.01 English; Version 08 | 2019-04-24... -
Page 5: Components
Foot-activated switch with connector cable DC cord Power cord Test instrument for electrical tests Figure 1: Components of the remOVE DC Impulse (Ref. No. 400.01) English; Version 08 | 2019-04-24 remOVE DC Impulse 400.01 Instructions for use 5 / 32... -
Page 6: Accessories / Replacement Parts
Please only use original parts or parts certified by the manufacturer as compatible with the remOVE DC Impulse as accessories or replacement parts. Otherwise safety and functionality cannot be guaranteed. The following accessories / replacement parts for the remOVE DC Impulse may be ordered separately: Accessory / replacement part Max. -
Page 7: Intended Use / Indication
Figure 3: Rear view of the remOVE DC Impulse Figure 4: Name plate of remOVE DC Impulse Intended use / indication ® The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC ® and FTRD clips made by Ovesco Endoscopy AG for the digestive tract. -
Page 8: Contraindications
It is not permitted to use the remOVE DC Impulse outside of its intended use as specified above. Using the remOVE DC Impulse for fragmentation of objects other than the products specified above may lead to defects and damages to the remOVE DC Impulse, destruction of the remOVE DC Cutter and permanent bonding of remOVE DC Cutter to the object. -
Page 9: Warnings / Precautions
Failure to comply may lead to a drop in product performance. MRI compatibility of the remOVE DC Impulse The remOVE DC Impulse is not MRI compatible. It must not be used in an MRI environment. English; Version 08 | 2019-04-24 remOVE DC Impulse 400.01... - Page 10 Applied parts and generator are not protected against defibrillation. Remove in- strument before using a defibrillator on the patient. 10 / 32 Instructions for use remOVE DC Impulse 400.01 English; Version 08 | 2019-04-24...
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Page 11: Components And Products Required For Use
Components and products required for use The remOVE DC Impulse may only be used in conjunction with manufacturer- approved accessories and products as detailed in the instructions for use. The use of accessories, cables and transducers, other than those the remOVE DC Impulse was designed for, can significantly increase emissions and reduce immunity of the remOVE DC Impulse against interference. -
Page 12: Preparation
Be advised that local law takes prec- edence over the normative requirements detailed above. When setting up the remOVE DC Impulse please make sure that the user has clear, unobstructed line of sight to the status display. - Page 13 Figure 7: Status display indicates charge during charging phase by flashing green LEDs corresponding to the charge level If the remOVE DC Impulse has not been in use for more than two days, the internal energy storage is fully charged over a time period of about 10 minutes.
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Page 14: Use Of Product
DC cord or a connection using several DC cords. This may also lead to damage of the remOVE DC Impulse. Make sure the clip can be removed. If the clip is deeply embedded superficial tissue removal may be necessary to bare the clip. - Page 15 DC Cutter and create a permanent con- nection between the electrodes. This is indicated by a constant audible signal without clip contact. The remains can be removed by applying a English; Version 08 | 2019-04-24 remOVE DC Impulse 400.01 Instructions for use 15 / 32...
- Page 16 Figure 10: Clip fragment with remOVE Grasper in the remOVE SecureCap Turn off the remOVE DC Impulse by pressing the ON/OFF switch. 16 / 32 Instructions for use remOVE DC Impulse 400.01...
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Page 17: Mode Of Operation
Should contact break off between the remOVE DC Cutter and the clip during the application of a DC pulse, the output of the remOVE DC Impulse will be deac- tivated within less than 500 µs. Breaking-off of contact might occur, for example, if one or both electrodes lose contact with the clip due to successful clip fragmen- tation. -
Page 18: Error Message
Figure 12: Status display flashes orange during failure message. If a failure message is displayed by the remOVE DC Impulse, acoustic contact de- tection between instrument and clip is deactivated. A DC pulse can no longer be generated, and the internal energy storage of the remOVE DC Impulse can no longer be recharged. - Page 19 Ob- serve specifications regarding concentration, temperature and exposure time. Apply alcohol-based cleaning/disinfection agent. Do not use benzyl-alcohol-based and/or any other agents because it can cause damages to the remOVE DC Impulse materials. 14.2 Instructions Prepare the cleaning/disinfectant agent per the manufacturer’s guidelines.
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Page 20: Transport And Shipping / Storage
It is recommended to thoroughly clean the remOVE DC Impulse before storing it. Do not expose the remOVE DC Impulse to direct or indirect sunlight or other types of UV radiation. Do not store the remOVE DC Impulse in the vicinity of chemicals, disinfectants and/or sources of radioactive radiation. -
Page 21: Maintenance / Repair
16 Maintenance / repair 16.1 In general After every use of the remOVE DC Impulse and its accessories, please check for damages or defects. Pay special attention to intact isolation of all cords and ca- bles. Never use a damaged remOVE DC Impulse or damaged accessories. Immedi- ately replace defective accessories. - Page 22 If repairs are needed, please contact the manufacturer. Do not attempt to repair the device yourself under any circumstances. Ovesco accepts liability with regards to safety, reliability and functionality of the device under the following circumstances: All instructions with regards to installation and intended use given in this document have been followed properly.
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Page 23: Disposal
700 to 1060 hPa ≤ 4000 m Operation level If the remOVE DC Impulse has been stored or transported at a temperature of less than + 10 °C, it must be acclimated to room temperature for at least 3 hours. 19 Specifications... - Page 24 One-time duration of impulse during activa- ≤ 65 ms tion ≤ 165 A Output current remOVE DC Cutter 1.3–2.0 V Output voltage remOVE DC Cutter ≥6 s Interval between activations 24 / 32 Instructions for use remOVE DC Impulse 400.01 English; Version 08 | 2019-04-24...
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Page 25: Electromagnetic Compatibility (Emc)
Electromagnetic emissions The remOVE DC Impulse is intended for use in the electromagnetic environment specified be- low. The customer or the user of the remOVE DC Impulse should assure that it is used in such an environment. Measurements of electromagnetic emissions... - Page 26 Guidelines and manufacturer's declaration Electromagnetic immunity The remOVE DC Impulse is designed for use in an electromagnetic environment as specified be- low. The user must ensure that the device is operated in such an environment. Compatibility test IEC 60601 test level...
- Page 27 Guidelines and manufacturer's declaration Electromagnetic immunity The remOVE DC Impulse is designed for use in an electromagnetic environment as specified below. The user must ensure that the device is operated in such an environment. IEC 60601-1-2: 2014-02 Compatibility test Compliance level...
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Page 28: Warranty
21 Warranty Ovesco Endoscopy AG, the manufacturer, grants a 24 months warranty on material and construction of the remOVE DC Impulse, starting from date of purchase. The warranty covers any faults occurring in the product due to the materials used in the manufacturing process or faulty installation by the manufacturer. -
Page 29: Symbols
Do not use if packaging is damaged Air pressure limit Air humidity limitation Temperature limitation Marking of electrical and electronic equipment according to applicable guideline 2012/19/EU (WEEE), see disposal English; Version 08 | 2019-04-24 remOVE DC Impulse 400.01 Instructions for use 29 / 32... - Page 30 Ensure that country-specific regulations and requirements, which include the generally accepted technical stand- ards, as well as valid regulations for occupational safety and accident prevention, will be implemented and com- plied with during setup, operation and maintenance. Device: remOVE DC Impulse Safety classification: Article no.: 400.01 Type of applied part: Serial no.:...
- Page 31 Contact the manufacturer if there is any deviation, abnormality and/or an indica- tion of error. The next inspection should be carried out after 12 months. Name of the inspector Date / signature English; Version 08 | 2019-04-24 remOVE DC Impulse 400.01 Instructions for use 31 / 32...
- Page 32 CE-marking according to EC directive 93/42 EEC Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 72076 Tuebingen Germany phone: +49(0)7071-96528-160 fax: +40(0)7071-96528-260 e-mail: service@ovesco.com website: www.ovesco.com 32 / 32 Instructions for use remOVE DC Impulse 400.01 English; Version 08 | 2019-04-24...
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