Innovex EOS-H-01 Instructions For Use Manual

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Instructions for use manual (26 pages)

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Video Processor 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

(English)

(English 英语)

职责

Personnel

张彦春

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

PMF-EOSH-006a

Version

A/7

签名

Signature

张彦春

范舒文

唐伟

2023 年 06 月 01 日

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Page 1 Document No PMF-EOSH-006a Video Processor Operation Manual (English) Version Video Processor Operation Manual (English 英语) 职责人员签名 Responsibility Personnel Signature Prepared by 张彦春张彦春 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 PMF-EOSH-006a Video Processor Operation Manual (English) Version Revision History Change Date Revision the Description 2019.12.12 New File 2020.03.13 Update expressions and add product pictures Change EU AR; 2020.04.08 Update address 2020.09.14 Optimize phasing of basic function and performance indicators Add monitor specification in Chapter 4 Add new caution in chapter 5.2 Preparing the Device;...
Page 3 Video Processor (Model: EOS-H-01) Instruction for Use 0344 Version: A/7 Effective date: 2023-06-01 Shanghai AnQing Medical Instrument Co., Ltd. PMF-EOSH-006a A/7...
Page 4: Table Of Contents
Contents User Notice ............................... 3 Intended Use ..............................3 Safety Information ............................3 Device Description ............................6 Preparation ..............................11 Operating the Device ............................ 13 Care/Maintenance/Repair .......................... 19 Trouble Shooting ............................21 EMC Information ............................23 Disposal ................................ 27 Explanation of Symbols Used ......................... 27 PMF-EOSH-006a A/7...
Page 5: User Notice
User Notice  Before initial use of the Video Processor (Model: EOS-H-01) , it is essential for operators to have received sufficient training in clinical endoscopic techniques and to be familiar with the intended use, warnings, cautions, indications and contraindications mentioned in these instructions.
Page 6 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 7 This manual does not include descriptions or instructions for surgical procedures/techniques. It is also not suitable for training physicians in the use of surgical techniques. Medical peripherals and devices may be used only by physicians or medical assistants with the appropriate technical / medical qualification working under the direction and supervision of a physician.
Page 8: Device Description
personnel. Caution! Check to make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device. Caution! Endoscope The device may only be connected with specified endoscope designed and manufactured by AnQing Medical.
Page 9 4.2 Packing list Item Unit Remark Video Processor Standard DVI cable (2.8M) Standard SDI cable (2.8M) Standard VGA cable (2.8M) Optional Power cable (2.8M) Standard 4.3 Equipment to be connected Item Unit Remark Endoscope by AnQing Refer to Endoscope IFU for compatibility of the Medical video processor Monitor compatibility requirements: medical...
Page 10 4.4 Specification and Device Compatibility Specification It has two DVI interfaces, one VGA interface Video interface and one SDI interface, and the two DVI can achieve synchronous output Establish the true color of white by adjusting White balance color temperature under ambient illumination...
Page 11 condition Relative Humidity 10%～80% Air Pressure 500hPa～1060hPa Product Life 5 years Type of Protection Against Electric Class I Shock Type of use reuse: Multiple patient multiple use Degree of Protection against electric shock Type BF Applied Part (Endoscope) Video Processor – Accessory Compatibility ...
Page 12 Warning! Danger of ignition Always comply with national regulations concerning avoiding the danger of ignition caused by electrostatic charges. Warning! Device type BF Degree of protection against electric shock. The endoscope must not have an electrically conductive connection to the casing of the Video Processor. Caution! Ambient temperature If the Video Processor is operated within an enclosed device tower or rack system, the operating...
Page 13: Preparation
Use accessories approved by the manufacturer only, or it will interfere with other medical electronic equipment used in combination. Preparation Delivery Inspection Always check all parts and accessories of the device immediately after receiving the shipment. 5.1 Scope of Delivery Check the delivered equipment for completeness.
Page 14 Warning! When the Video Processor is used with other electrical medical equipment, the applied parts must be Type BF or Type CF applied parts. Components added to the endoscope system by the user must be certified to the respective IEC standards (IEC 60601-1 for medical equipment, IEC 60950 for data processing equipment, and IEC 60065 for A/V equipment) or other country equivalent.
Page 15: Operating The Device
Disconnect the device from the mains power supply if the device will not be used for several days or longer. Warning! Always grasp the power plug when disconnecting the device from the power supply. Never pull on the cable itself. Operating the Device ⑨...
Page 16 ⑩ Power socket (with double fuse) ⑪ Product label Installation and Operation 1) The Video Processor is connected through the power cable to the ⑩Power socket on the back panel of the video processor; 2) Connect to the monitor ⑤DVI interface, ⑥VGA interface or ⑦HD-SDI interface, by using corresponding signal transmission cable;...
Page 17 Power On/Off button  Press power switch on the video processor to start (green light on). The monitor shows the welcome Return interface for 2 seconds, then enters patient ID. If you don’t want to enter ID, press the button to skip.
Page 18 Press the OSD button to change image display shape – round, square and octagonal The green light will indicate corresponding display shape. FRZ button  Press FREEZE button to freeze image. During image freezing the word " Image Frozen " appears on the display.
Page 19 2) Checking the Image Quality Before using, hold the distal tip of the endoscope close to an object and ensure monitor displays a clear, sharply focused, high-quality image. Confirm the “real-time” appearance of the image on the monitor. Confirm the image is oriented correctly. Ensure the image is showed properly before beginning the procedure.
Page 20 Choose the default setting from 3 preset image mode settings or custom image setting. i. Press to choose item you want to adjust, then press to enter the adjustment mode and press to adjust parameters. Then press to confirm the setting. ii.
Page 21: Care/Maintenance/Repair
When there are zero minute remaining, the “Use Time Exceeded” message will appear on the image display. If additional time is needed for the procedure, after the “Use Time Exceeded” message displays, a new endoscope will need to be used. Care/Maintenance/Repair Caution! The Video Processor (or parts of the Video Processor) must NOT be sterilized (e.g.
Page 22 The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging. Please make sure that all required information has been supplied: • Name of owner • Address of owner •...
Page 23: Trouble Shooting
Please contact your local distributors for registration first. AnQing Medical or its authorized professionals will provide the definite fault causes and repair budget to the customer. After communication and acknowledgment with the customer, they will repair or replace the parts, then return the product to the customer.
Page 24 Replace with another Endoscope failure endoscope or contact the local distributor Loose connection between the Check and reconnect endoscope and the Video endoscope to video Processor processor Replace with another Video Start-up image remains Video Processor failure Processor or contact the local frozen distributor No display on the...
Page 25: Emc Information
Replace with another Endoscope failure endoscope or contact the local distributor Do not share a power outlet Power supply is unstable with other high-powered equipment Image flashing or Ensure the Video Processor’s rippling location meets the Electromagnetic interference Electromagnetic from other equipment Compatibility Section 9.
Page 26 This instrument uses RF (Radio Frequency) energy only for CISPR 11 its internal function. Therefore, its RF emissions are very low Conducted Emissions Group 1 Class A and are not likely to cause any interference in nearby electronic equipment. CISPR 11 Radiated Emissions Group 1 Class A Harmonic...
Page 27 Compliance Immunity test IEC 60601 test level Electromagnetic environment-Guidance level Input a.c. power Port Line-to-line ± 0,5 kV, ± 1 kV Surge Line-to-ground Mains power quality should be that of a typical Same as left IEC 61000-4-5 ± 0,5 kV, ± 1 kV, ± 2 kV commercial or hospital environment.
Page 28 any part of the system, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.17√P d = 1.17√P 80 MHz to 800 d = 2.33√P 800 MHz to 2.7 Where P is the maximum output power rating of the transmitter in watts (W)
Page 29: Disposal
the system. ·Over the frequency range 150kHz to 80MHz, field strengths shall be less than 3 V/m. Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and System The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 30 Catalogue number Quantity Refer to instruction Caution manual/booklet Keep dry This way up Fragile, handle with care Keep away from sunlight Temperature limit: Waste management between -40° and 55° in storage environment Atmospheric pressure Humidity limitation： limitation: Between 10% and 80% in Between 500hPa and storage storage...
Page 31 PMF-EOSH-006a A/7...

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