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Innovex EOS-H-01 Instructions For Use Manual

Flexible ureterorenoscope
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Flexible Ureterorenoscope Operation
Flexible Ureterorenoscope Operation Manual
Responsibility
Prepared by
Reviewed by
Approved by
The document was proposed by Shanghai AnQing Medical Instrument Co., Ltd.
发布日期：
机密 Classified Documents
版权所有，未经允许，不得复制！
Manual (English)
(English 英语)
职责
Personnel
高瑞峰
范舒文
本文件由上海安清医疗器械有限公司提出
2022 年 11 月 14 日
Issued on 2022-11-14 and implemented from 2023-06-01
Shanghai AnQing Medical Instrument CO., Ltd.
人员
唐伟
实施日期：
上海安清医疗器械有限公司
Document No
IFU-US2-011-01
Version
签名
Signature
高瑞峰
范舒文
唐伟
2023 年 06 月 01 日
页码
Page
A/5
1 / 2

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Summary of Contents for Innovex EOS-H-01

  • Page 1 Document No IFU-US2-011-01 Flexible Ureterorenoscope Operation Manual (English) Version Flexible Ureterorenoscope Operation Manual (English 英语) 职责 人员 签名 Responsibility Personnel Signature Prepared by 高瑞峰 高瑞峰 Reviewed by 范舒文 范舒文 Approved by 唐伟 唐伟 本文件由上海安清医疗器械有限公司提出 The document was proposed by Shanghai AnQing Medical Instrument Co., Ltd. 2022 年...
  • Page 2 Document No IFU-US2-011-01 Flexible Ureterorenoscope Operation Manual (English) Version Revision History Change Date Revision the Description 2019.12.12 New File 2020.03.13 Update expressions 2020.04.08 Change EU AR; Update address Delete model of US31C series; Update Storage temperature; Update expression of “Photo/Video” Button Description in Chapter 3; 2020.07.30 Update tolerance of FOV;...
  • Page 3 Flexible Ureterorenoscope Instruction for Use Only to be used with Video Processor （Model: EOS-H-01, Software version EOSH_V1.00 or higher） approved by AnQing Medical 0344 Version: A/5 Effective date: 2023-06-01 Shanghai AnQing Medical Instrument Co., Ltd. IFU-US2-011-01 Ver. A/5...

  • Page 4: Table Of Contents

    Contents User Notice ........................3 Intended Use ........................3 Device Description ......................4 Safety Information ......................9 How Supplied ........................13 Storage and Transportation ..................13 Operation Instructions ....................13 EMC Information ......................18 Explanation of Symbols Used ..................22 IFU-US2-011-01 Ver.

  • Page 5: User Notice

    1 User Notice  The AnQing Medical Single-Use Flexible Ureterorenoscope may only be used by persons with an appropriate medical qualification and who are acquainted with the technique of ureterorenoscope. This manual is not intended as an introduction to the technique of Ureterorenoscopy.

  • Page 6: Device Description

    Only to be used with Video Processor (Model: EOS-H-01， Software version EOSH_V1.00 or higher) approved by AnQing Medical. ONLY Federal (USA) law restricts this device to sale by, or on the order of, a physician or other appropriately licensed medical professional.
  • Page 7 Model: US31D-12-EU / US31D-12-US 1. Camera (CMOS) Collect endoscopic image. 2. LED LED light source on the tip of endoscope 3. Working Channel This channel allows for the use of flexible auxiliary instruments as well as irrigation fluid. 4. Distal Tip Distal Tip integrated with LED light source, camera system and working channel.
  • Page 8 Long press (more than 2 seconds) for starting recording and long press again for finishing recording. 17. Endoscope connector Endoscope connector is designed to connected only with socket on the front panel of Video Processor (Type: EOS-H-01) produced by AnQing Medical. Model: US31E-12-EU / US31E-12-US IFU-US2-011-01 Ver. A/5...
  • Page 9 1. Camera (CMOS) Collect endoscopic image. 2. LED LED light source on the tip of endoscope 3. Working Channel This channel allows for the use of flexible auxiliary instruments as well as irrigation fluid. 4. Distal Tip Distal Tip integrated with LED light source, camera system and working channel. 5.
  • Page 10 Deflection Lever is turned to the “0” direction, the Distal Bending Section is kept STRAIGHT. 15. Endoscope Connector Endoscope Connector is designed to connected only with socket on the front panel of Video Processor (Type: EOS-H-01) produced by AnQing Medical. 3.2 Product Reference No. Product Reference No. Deflection...

  • Page 11: Safety Information

    T28A T-Luer Video Processor (Flexible Ureterorenoscope can use Video Processor Model: EOS-H-01 only) EOS-H-01 Video Processor (need to order separately) 3.3 Specifications Table 1 Single-Use Flexible Ureterorenoscope Specification Specification Measures Distal End Outer diameter 3.2mm (9.6Fr) Working Channel Inner diameter 1.2 mm (3.6Fr)
  • Page 12 Warning  Do not allow any electrical components or electrical instruments to come into contact with the Flexible Ureterorenoscope, such as HF surgical equipment.  Inspect the Flexible Ureterorenoscope prior to each surgical procedure to ensure that it functions correctly and that its sterile package integrity. The function test must be performed prior to each surgery.
  • Page 13 monitor may differ from the actual brightness at the distal end of an endoscope.  When discontinuing the use of the endoscope, be sure to turn the light source OFF so that the endoscope does not irradiate unnecessary light.  If the endoscopic image dims during use, blood, mucus or debris may adhere to the light guide on the distal end of the endoscope.
  • Page 14 country equivalent. In addition, the user must ensure the new configuration complies with local regulations and hospital requirement for electrical safety.  Use the Flexible Ureterorenoscope with caution in patients who have undergone previous urinary tract reconstructive surgery or with known strictures. These conditions may prevent passage of the flexible scope shaft.

  • Page 15: How Supplied

    endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their nature, extent, and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient.
  • Page 16 Ambient temperature: 10 °C °C Humidity: 30%~80% Electromagnetic compatibility This instrument has been tested and complies with the EMC limits as per EN/ IEC 60601-1-2 CISPR 11 Group 1 Class A. Handling Note: Damage to the Flexible Ureterorenoscope resulting from incorrect operation is not covered by the manufacturing’s warranty.
  • Page 17 Turn the Deflection Lever smoothly and slowly. Warning: Before use, always check that the Deflection Lever can perform distal tip deflection function correctly. Defective Flexible Ureterorenoscope must not be used. Inspecting the LED function Prepare video processor as described above and connect to the Flexible Ureterorenoscope. Emission of light at the distal end should be recognizable.
  • Page 18 therefore be replaced! Operating The following instructions outline the correct operation of the Flexible Ureterorenoscope and the corresponding accessories. This is not an introduction to the techniques of ureterorenoscopy. Instruction on endoscopic technique can be found in the relevant medical literature. Holding the Flexible Ureterorenoscope correctly Grip the handle of the Flexible Ureterorenoscope in your left or right hand, and move the Deflection Lever with your thumb to deflect.
  • Page 19 Warning: Suitable accessories, such as laser fibers, must only be introduced into the working channel of the Flexible Ureterorenoscope with the distal tip in the neutral, non-deflected “0” position. Once the instrument has been introduced, actuate the Deflection Lever gently and carefully as far as the limit stop.

  • Page 20: Emc Information

    The Flexible Ureterorenoscope does not contain latex and phthalate. After use, dispose the Flexible Ureterorenoscope according to national laws and regulations. Waste management This symbol indicates that the waste of electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately instead. The user must discard and dispose the product by local laws and hospital management specifications.
  • Page 21 Group 1 Class A for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. CISPR 11 Radiated Emissions Group 1 Class A Harmonic Current This instrument is predominantly intended to be Emissions connected (e.g.
  • Page 22 Compliance Electromagnetic Immunity test IEC 60601 test level level environment-Guidance Input a.c. power Port Line-to-line ± 0,5 kV, ± 1 kV Mains power quality should be that Surge Line-to-ground Same as left of a typical commercial or hospital IEC 61000-4-5 ±...
  • Page 23 Conducted 3 V RMS 3 V RMS disturbances 0,15 MHz – 80 MHz 0,15 MHz – 80 MHz Portable and mobile RF induced 6 V RMS in ISM bands 6 V RMS in ISM communications equipment fields 80 % AM at 1 kHz bands 80% AM at 1 should be used no closer to IEC 61000-4-6...

  • Page 24: Explanation Of Symbols Used

    electromagnetic site survey shall be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above, the system shall be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.
  • Page 25 Catalogue number Quantity Consult instructions for use or consult Do not re-use. electronic instructions for use. Do not use if package Date of manufacture is open or damaged. Do not resterilize Manufacturer Sterilized using Use-by date ethylene oxide Keep dry Waste management Upward Temperature limit...
  • Page 26 Federal Law (USA) restricts this device to sale by or on the order of a physician. IFU-US2-011-01 Ver. A/5...

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