Storz IMAGE1 S HX Instructions For Use Manual
Camera head
Hide thumbs
Also See for IMAGE1 S HX:
- Instruction manual (90 pages) ,
- Instructions for use manual (64 pages) ,
- Service instructions manual (40 pages)
Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for Storz IMAGE1 S HX
Summary of Contents for Storz IMAGE1 S HX
- Page 1 Instructions for use IMAGE1 S HX Camera Heads...
- Page 2 08-2022 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.
-
Page 3: Table Of Contents
9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ..18 9.4 Table 3 – Test levels for radiated and conducted immunity tests ..........19 9.5 Table 4 – Emission class and group ..................20 Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... - Page 4 Table of contents 9.6 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ................. 21 10 Subsidiaries ............................22 Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR...
-
Page 5: General Information
Step 1 ð Interim result of an action Step 2 ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1 Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 6: 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 • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 7: Normal Use
The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.5 Patient population There are no restrictions in terms of patient groups for this product. Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 8: Safety And Warning
Only use devices and components that have standardized interfaces and do not breach the normal use of the product. Do not modify this equipment without authorization of the manufacturer. Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 9: Dangers From Electrical Current
Never allow HF devices to come into contact with the product or system. 3.8 Failure of products The product may fail during use. Have a replacement product ready for each application or plan for an alternative surgical technique. Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 10: Product Description
Combination with camera control unit (CCU) Camera head LINK module TH110 IMAGE1 S CONNECT (TC200) IMAGE1 S X-LINK (TC301) TH111 IMAGE1 S CONNECT II (TC201) TELE PACK + (TP101) TELECAM C3 (TC100) Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 11: Technical Data
Consult the printed or electronic instructions for use Note for the user to consult the instructions for use for important cautionary in- formation such as warnings and precautions. Unsterile Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 12: Ambient Conditions
The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. 4.5 Ambient conditions Storage/transport conditions Temperature -10°C ... 60°C (14°F ... 140°F) Relative humidity 20–95% Operating conditions Temperature 5°C ... 35°C (41°F ... 95°F) Relative humidity 20–95% (non-condensing) Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 13: Preparation
Rotate the outer ring of the instrument coupler counterclockwise to tighten it. 5.3 Connecting the light cable Tighten the knurled screw on the light cable by a quarter turn to connect the light cable. Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 14: Application
Ensure that the correct video image is displayed on the monitor before starting the procedure. Turn the focus ring to adjust the image sharpness on the camera lens. IMAGE1 S HX Camera Head (TH110) IMAGE1 S HX-P Camera Head (TH111) Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 15: Maintenance, Servicing, Repairs, And Disposal
7 Maintenance, servicing, repairs, and disposal 7.1 Repairs to the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). -
Page 16: Accessories And Spare Parts
Camera Cover, sterile, for single use, pack of 40 040115-40 Camera Cover, sterile, for single use, pack of 40 040169-40 Camera Cover, sterile, for single use, pack of 25 040170-25 Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... -
Page 17: Electromagnetic Compatibility
Dip to 70% for 25/30 cy- Dip to 70% for 25/30 cy- IEC 61000-4-11 of the product requires cles at 0° phase angle cles at 0° phase angle continued operation in Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR... - Page 18 Pulse modula- tion 18 Hz 430 – 470 GMRS 460, FM ± 5 kHz de- FRS 460 viation 1 kHz sine wave 704 – 787 LTE band 13 Pulse modula- and 17 tion 217 Hz Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR...
- Page 19 Recommended separation distances: d = 1.2 √P Where P is the rated power of the transmitter in watts [W] according to the infor- mation provided by the Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR...
- Page 20 Class A The device is suitable for use in all es- tablishments other than domestic and Emission of harmonic oscillations Class A those directly connected to the public acc. to IEC 61000-3-2 Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR...
- Page 21 Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. The product was tested for compatibility with HF surgical devices in accordance with IEC 60601-2-2 Appendix BB. Instructions for use • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR...
- Page 22 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 • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR...
- Page 23 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 • IMAGE1 S HX Camera Heads • NAM292_EN_V2.0_08-2022_IFU_CE-MDR...
- 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...
Need help?
Do you have a question about the IMAGE1 S HX and is the answer not in the manual?
Questions and answers