Table of Contents
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Table of Contents
Related Manuals for Storz 11301D4
Summary of Contents for Storz 11301D4
- Page 1 Instructions for use LED battery light source with fast screw thread...
- Page 2 11-2020 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
Table of contents Table of contents 1 General information............................ 4 Read the instructions for use ........................ 4 Scope................................ 4 Description of warning messages...................... 4 2 Normal use.............................. 5 Intended use ............................. 5 Indications.............................. 5 Contraindications............................ 5 Target user populations .......................... 5 Patient groups............................ 5 3 Safety ................................ 6 Serious incidents ............................ 6 Correct handling ............................ 6 Correct reprocessing .......................... 6 Contaminated products .......................... 6... -
Page 4: General Information
Product Article number LED battery light source 11301D4 1.3 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger. -
Page 5: Normal Use
Battery light sources are mobile light sources and are used for generating and transmitting light to KARL STORZ endoscopes in ENT medicine. Battery light sources are non-invasive and are designed for transient use in invasive procedures through a body orifice 2.2 Indications... -
Page 6: Safety
Safety 3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): – Death of a patient, user, or another person –... -
Page 7: Damaged Products
Safety 3.6 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the products for damage. Do not use damaged instruments. 3.7 Failure of systems The system may fail during use. Have a replacement system ready for each application. -
Page 8: Product Description
The battery light sources can be used with the following components: – Batteries: – Panasonic CR123A with UL Recognized Component Mark (UR) – Duracell DL123A with UL Recognized Component Mark (UR) – Endoscopes/fiberscopes: – All KARL STORZ telescopes with light connection 4.3 Technical data Property Value Dimensions (L x H x W) 95 x 40 x 20 mm Weight 80 g (without battery) -
Page 9: Symbols Employed
Product description 4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol Meaning Number of products in the product packaging Article no. Batch code Medical device US Federal law (21 CFR 801.109) restricts this device to sale to or on the order of a licensed physician Manufacturer Date of manufacture... -
Page 10: Symbols On The Product
Product description 4.4.2 Symbols on the product Symbol Meaning Follow instructions for use Heat emission Applied part type BF Article no. Batch code Separate collection of electrical and electronic devices. Do not dispose of in household refuse. CE conformity mark With this mark, the manufacturer declares the compliance of the prod- ucts with the applicable regulation (EU) 2017/745. -
Page 11: Preparation
Preparation 5 Preparation 5.1 Unpacking the product Carefully remove the product and accessories from the packaging. Check the delivery for missing items and evidence of shipping damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. -
Page 12: Application
The LED flashes several times to signal the end of the battery service life. The flashing repeats at 2-minute intervals until the battery is completely discharged after 5–10 minutes: Model Operating time Comment 11301D4 2 h – 2 batteries – Rechargeable batteries must not be used. -
Page 13: Maintenance, Servicing, Repairs, And Disposal
Check that the battery light source is functioning properly and then switch it off. 7.2 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. -
Page 14: Disposing Of The Product
Maintenance, servicing, repairs, and disposal Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products. -
Page 15: Electromagnetic Compatibility
Electromagnetic compatibility 8 Electromagnetic compatibility 8.1 General notes on the operating environment The product is suitable for use in professional healthcare settings. Professional healthcare facilities include physician offices, dental offices, limited care facilities, freestanding surgical centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system for MRT). - Page 16 Electromagnetic compatibility Interference im- EN/IEC 60601 test Compliance level Electromagnetic envi- munity tests level ronment – Guidelines 100% for 250/300 cy- ated with an uninter- cles ruptible power supply or a battery. Magnetic field at 30 A/m at 30 A/m at If image distortion oc- power frequency 50 Hz /60 Hz 50 Hz /60 Hz...
- Page 17 Electromagnetic compatibility Test fre- Frequency Radio service Modulation Immunity Compliance quency band test level level 1,720 1,700 – 1,990 GSM 1800, Pulse modula- CDMA 1900, tion 1,845 GSM 1900, 217 Hz DECT, 1,970 LTE band 1, 3, 4, 25, UMTS 2,450 2,400 –...
- Page 18 Electromagnetic compatibility Interference immunity EN/IEC 60601 test Compliance Electromagnetic envi- tests level level ronment – guidelines Field strengths from fixed HF transmitters as deter- mined by an electromag- netic site survey should be less than the compli- ance level in each fre- quency range d = 1.2 √P 80 MHz to 800 MHz...
- Page 19 Electromagnetic compatibility Interference emission mea- Compliance Electromagnetic environment – surements Guidelines Voltage fluctuations/flicker emis- nected to the public low voltage power sions acc. to IEC 61000-3-3 supply network that supplies buildings used for domestic purposes. 8.6 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product The product is intended for use in an electromagnetic environment in which HF disturbances...
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Page 20: Subsidiaries
KARL STORZ Veterinary Endoscopy-America, Inc. Email: info-be@karlstorz.com 1 South Los Carneros Road, Goleta, CA 93117, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 805 968-7776, Fax: +1 805 685-2588 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Email: info@karlstorzvet.com... - Page 21 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. Email: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 22 Subsidiaries Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CE-...
- Page 23 Subsidiaries Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CE-...
- 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...