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Summary of Contents for Storz HOPKINS
- Page 1 Instructions for use HOPKINS Telescopes for Hysteroscopy...
- Page 2 09-2023 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.
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Page 3: Table Of Contents
6.1 Repairing the product ........................ 16 6.2 Disposing of the product ......................16 7 Accessories and spare parts ......................17 7.1 Accessories ..........................17 7.2 Spare parts ..........................17 8 Subsidiaries ............................19 Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 4: General Information
The signs and symbols used in this document have the following meaning: Practical tip This sign refers to useful and important information. Actions to be performed Action to be carried out by several steps: Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 5: Description Of Warning Messages
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. NOTICE NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 6: Normal Use
Normal use 2 Normal use 2.1 Indications The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. 2.2 Contraindications Absolute Contraindications for Diagnostic and Operative Hysteroscopy –... -
Page 7: Residual Risks
Uterine perforation resulting in possible injury to bowel, bladder, major blood vessels, and ureter – Pulmonary edema – Cerebral edema – Spread of cancerous cells in case of malignant diseases Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 8: Safety And Warning
If the fiber bundle diameter of the fiber optic light cable is too small, not enough light will enter the endoscope. This may mean that the operating area is not sufficiently illuminated. Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 9: Hot Components
Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeldt-Jakob disease has been diagnosed or is suspected: Do not continue to use the product. Dispose of the product properly; see Disposing of the product. Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 10: Product Description
Interface between telescope and light cable If there is an identification symbol on light cables and endoscopes, the matching combinations should be assigned according to the symbols shown. Special endoscopes may deviate slightly. Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 11: Technical Data
16° Angle of image field 68° Color code Black 26105BA Designation Value Working length 300 mm Max. insertion width 4 mm Direction of view 25° Angle of image field 68° Color code Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... - Page 12 Data in product descriptions and catalog texts refer to commonly used nominal values and may differ from the actual values in the technical data. Some values have been rounded. Tolerances are compliant with standard ISO 8600-1:2015. Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA...
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Page 13: Symbols On The Packaging
Unsterile Fragile, handle with care Temperature limit Humidity limit Transport conditions In one combined field surrounded by a border with the “conditions for trans- port” symbol: Temperature limit for transport Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 14: Ambient Conditions
There are no special operating conditions for this product. For 26105FA Transport conditions and storage conditions Temperature -29°C ... +50°C (-20°F ... +122°F) Relative humidity 5–85% (non-condensing) Operating conditions There are no special operating conditions for this product. Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 15: Preparation
Check the delivery for missing items and possible damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... -
Page 16: Maintenance, Servicing, Repairs, And Disposal
6 Maintenance, servicing, repairs, and disposal 6.1 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). -
Page 17: Accessories And Spare Parts
For 26053CD: Article Order no. Stopcock 8515090 Spring cap 6985691 O-ring, inner Ø 7 x 1 mm 5920800-10 Sealing Cap 27550A-10 For 26055CD: Item Order no. Stopcock 6626690 Spring cap 6377091 Sealing Cap 27550A-10 Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... - Page 18 Accessories and spare parts For 26069CD Item Order no. Stopcock 8458190 Spring cap 6985691 Sealing Cap 27550A-10 Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA...
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Page 19: Subsidiaries
Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Istanbul, Turkey Phone: +90 216 442 9500, Fax: +90 216 442 9030 **Sales for Industrial Endoscopy Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA... - Page 20 Room 803-805, 8F Jin Jiang International Building, No. 1 West Linjiang Road, Wuhou District, 6100414, Chengdu, People’s Republic of China Phone: +86 28 86587977, Fax: +86 28 86587975 E-Mail: info@karlstorz.com.cn Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA...
- Page 21 Subsidiaries Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA...
- Page 22 Subsidiaries Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA...
- Page 23 Subsidiaries Instructions for use • HOPKINS Telescopes for Hysteroscopy • 154CHP_EN_V1.0_09-2023_IFU_FDA...
- Page 24 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...
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