EV-NC 327 460 xxx Video Nasopharyngoscope User Manual Rev Nov 2014

This User Manual is protected by copyrights. No part of it may be copied or transferred into other languages without the express prior written consent of XION GmbH. The product names and names of companies used in this User Manual are in most cases registered trade marks, and as such they are subject to the relevant legal provisions. XION GmbH lays no claims whatsoever to these trademarks.

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Fon: Fax:

+49 (0) 30 / 47 49 87 – 0 +49 (0) 30 / 47 49 87 – 11

E-Mail: Internet:

[email protected] www.xion-medical.com/en

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Contents Chapter

Title

Page

Contents ... 3 Intended Purpose ... 5 Fields of Application, Indication ... 5 Directions for Using the Manual ... 5 1 1.1 1.2 1.3

Safety Precautions ... 6 Safety Precautions ... 6 ESD Protection Measures ... 8 Electromagnetic Compatibility (EMC) ... 8

2 2.1 2.2 2.3

Product Description ... 9 Scope of Delivery ... 9 Overview of the Features: ... 10 Functional Elements ... 11

3 3.1

Combination and Interaction with Other Devices ... 13 Compatibilities ... 13

4 4.1 4.2 4.2.1 4.3 4.3.1 4.4 4.4.1 4.4.2

Product Application ... 14 EV-NC Video Nasopharyngoscope and XION Control Unit ... 14 EV-NC Video Nasopharyngoscope and XION Adapter Box ... 15 Connection to a medical monitor ... 15 Integrated Microphone ... 16 Installing the microphone ... 16 Function Keys ... 17 Key functions in a system with an adapter box and a monitor ... 17 Key functions on a system with an EndoCOMPACT ... 18

5 5.1 5.1.1 5.1.2 5.2 5.2.1 5.2.2 5.2.2.1 5.2.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 5.2.8

Reprocessing the Video Nasopharyngoscope ... 19 General ... 19 General Principles ... 19 Commissioning ... 19 Recommended Procedure for Complete Reprocessing ... 20 Pre-cleaning ... 21 Leak test ... 22 Checking the components ... 22 Performing a leak test ... 23 Preparatory rigging ... 24 Manual cleaning ... 26 Manual disinfection ... 26 Final rinsing, drying and functional test ... 27 Disinfection in CDD-E ... 27 Sterilization with Steris System 1 ... 30

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5.2.9 5.2.10

Sterilization in STERRAD 100 NX by means of H2O2 plasma sterilization ... 30 Low-temperature steam formaldehyde sterilization (LTSF) ... 30

6 6.1 6.1.1 6.1.2 6.1.3 6.2 6.3 6.4 6.5 6.5.1 6.5.2

Maintenance and Service ... 31 User Maintenance ... 31 General information ... 31 Transport ... 31 Storage ... 32 Manufacturer's Service ... 33 Returns ... 34 Disposal ... 34 Spare Parts and Accessories ... 35 Spare parts ... 35 Recommended accessories ... 35

7

Technical Data ... 36

8 8.1

Appendix ... 37 Disinfectants ... 37

9

Declarations Regarding EMC ... 39

10

Explanation of the Graphic Symbols Used ... 42

11

Manufacturer and Distributor ... 44 List of Figures ... 45 Index ... 46

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Important Information Please read this information before use

Intended Purpose The flexible XION EV-NC Video Nasopharyngoscope is a high-end medical device. It serves as a tool for endoscopic examinations of the nasal pharynx and nasal cavities, and is used for stroboscopic observations of the larynx. The intended user is the physician who is trained/experienced in endoscopy and/or minimally invasive surgery and who has read the User Manual. This equipment is not intended for operation by medical assistants.

Fields of Application, Indication The XION EV-NC Video Nasopharyngoscope is equipped with an ergonomically angled handle. It is used for routine diagnostics in ENT medicine. XION video nasopharyngoscopes may be used only for the described purpose and in the described manner.

Directions for Using the Manual The User Manual provides information about the safe, proper and efficient use of the medical device. Please take the time to read the complete User Manual carefully prior to commissioning the medical device; start with Chapter 1 - Safety Precautions, from page 6. Make sure that the User Manual is always within reach. The contents of this User Manual does not, however, replace any medical or technical knowledge. Such expertise is subject to the user’s special education or further education. XION GmbH is not liable for diagnoses and interpretations of findings based on the application of this medical device. Acquiring special medical knowledge as well as drawing diagnostic and therapeutic conclusions is solely subject to the user of this medical device.

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1 Safety Precautions

1

Safety Precautions

1.1

Safety Precautions The video nasopharyngoscope should only be used according to its intended purpose as to the regulations of the MPG, the common state of the art, and as to the prevailing labour protection and accident prevention rules. The instrument may only be used by physicians and medical assistants who, through their specialist qualifications can ensure that the device is handled in the proper manner. Before using the video nasopharyngoscope: Visually inspect the device to ensure its functional safety and proper working condition. Do not use the video nasopharyngoscope if you detect any damage that could jeopardize the patient, the user, or third persons. Use a cotton swab to wipe the flexible tube surface and then examine it visually to ensure that it is undamaged. Before each use, the functions of the device must be checked (bend function for distal tip, image playback, key functions, etc.). It must also be ensured that the light exit at the distal tip of the insertion tube is not contaminated, since otherwise there is a risk of dangerous heating above 41°C for the patient. •

Using the XION EV-NC Video Nasopharyngoscope as an application part is permitted only when it has been properly connected!

•

Contact between the XION EV-NC Video Nasopharyngoscope with a not connected patient connecting cable (e.g. electrically powered operating table) must be avoided.

•

When introducing and removing the video nasopharyngoscope from the nasopharyngeal zone, it must be ensured that the user himself and the patient do not look directly into the light exit, otherwise eye injuries may result.

The video nasopharyngoscope is a high-end precision-engineered optical instrument. Make sure to treat it with care. It is particularly important to avoid the sensitive flexible tube from being subjected to torsional strain (twisting). Avoid direct sunlight, X-rays, sudden strong temperature variations, heating above 60°C, and mechanical stress such as shocks and sharp bending of the insertion tube. In the vicinity of the endoscope, be careful with pointed or sharp objects such as scalpels or needles. Caution! Warning: Avoid high increases in temperature! High-energy endoscopic light can exit from the fibre-optic output of the video nasopharyngoscope. Deposits in the fibre-optic output area, insufficient work distances or direct tissue contact can result in high temperatures above 41°C and possible tissue damage due to thermal radiation. Always avoid direct contact with tissue in the light emission area! The fibre-optic output must not be placed directly onto the body or on any inflammable materials.

Caution! Warning: Risk of fire! The high energy radiated at the distal end may give rise to high temperatures or fire if the endoscope is placed on heat-sensitive or flammable surfaces. Therefore, always place the endoscope in the suitable appliances.

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Caution! The instrument is not suitable for operating in potentially explosive areas. When using, for example, readily combustible and explosive anaesthetic substances or flammable, slightly volatile skin cleaning and skin disinfecting substances, make sure that the instrument is not used in a hazard zone as defined by the manufacturer. •

Note:

Connect and operate the XION EV-NC Video Nasopharyngoscope only under the conditions specified in the Technical Data (Chapter 7 - Technical Data, page 36)!

The medical device's operational reliability and availability depend not only on your ability, but also on the maintenance provided. Regular cleaning and maintenance (see Chapter 5 - Reprocessing the Video Nasopharyngoscope, page 19) are imperative. •

When reprocessing the video nasopharyngoscope and accessories, use only the cleaning agent and disinfectant named in the User Manual, otherwise the medical device could be damaged.

Repairs may be carried out only by specialist staff authorized by XION GmbH.

Cautious and careful work is the best protection against accidents!

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1 Safety Precautions

1.2

ESD Protection Measures Electrical, electronic and optoelectronic components are at risk when subjected to electrostatic charges, which can cause them to malfunction or even to be destroyed. The XION EV-NC Video Nasopharyngoscope has been tested for its ESD strength within the scope of DIN EN 60601-1-2. However, the user is required to ensure that ESD protection measures are maintained to protect the medical device from destruction. These include: •

Avoiding direct contact with exposed connectors.

•

Avoiding synthetic clothing or footwear that has a highly electrically insulated sole.

•

Before working with the EV-NC video nasopharyngoscope (connecting or removing the device from the optional XION Adapter Box) any possibly existing charges on the body should be dissipated by discharging the body (touching large metal objects or ground potential/PA).

•

Before installing the system or connecting/attaching the medical device to the optional XION Adapter Box, all persons responsible for handling the equipment (including MT-staff) must be informed about the above named ESD protection measures and trained for their effective implementation. Besides an explanation of the meaning of the ESD warning sign, the content of the training should include at least the following: physical principles underlying the formation and effects of electrostatic  The discharge: Electrostatic charging is caused by frictional electricity (e.g. walking on carpet, wearing synthetic clothing) and, due to the high potential difference that arises, this in turn leads to sparking or to a disruptive discharge of voltage pulses up to 30,000 V. These voltage pulses discharge within a very short space of time (fractions of picoseconds to nanoseconds) with sometimes devastating effects on the electronic components of devices. of preventive methods and the effectiveness of protective  Explanation measures: Effective measures of protection are aimed at avoiding the original cause of electrostatic charging, i.e. preventing or minimizing such charging, for example by dissipation or by grounding the human body, wearing clothes and shoes made of nonsynthetic materials.

1.3

Electromagnetic Compatibility (EMC) Mobile HF communication facilities can influence electric medical devices! For example, do not operate any mobile phones in the vicinity of electric medical devices, see also Chapter 9 - Declarations Regarding EMC, page 39. Using any accessories, transformers and lines other than those specified, with the exception of transformers and lines that are offered by XION in the scope of supply or as spare parts for XION components, can lead to increased emissions or cause a decrease in immunity of the system. Using XION accessories, converters or lines in combination with equipment other than the specified XION devices and systems can lead to increased emissions or a reduction in the immunity of the system.

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2

Product Description

2.1

Scope of Delivery • EV-NC Video Nasopharyngoscope Art. No. 327 460 040

or • EV-NC Video Nasopharyngoscope with Olympus valve

햲

햳

Art. No. 327 460 240

• Art. No. 327 450 240 • Reprocessing stopper 햲 for microphone connection Art. No. 327 009 006

• Microphone for video nasopharyngoscopes 햳 (already installed) Art. No. 327 009 020

• ETO ventilation cap with instruction label Art. No. 130 009 010

• Leak tester for fibre-optic endoscopes Art. No. 130 009 012

• Connection set for RDG-E connection Art. No. 130 009 014

• Protective film for repair items Art. No. CA903057

• User Manual • Alu toolcase • Repair Service Manual Note:

To start with, please check the package, the transport case and your medical product for shipment damage. In the event of damage, make a note of the quantifiable scope of damage and report it to your dealer or manufacturer (Chapter 6. 2 - Manufacturer's Service, page 33). Please check the goods for completeness and integrity.

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2 Product Description

2.2

Overview of the Features:

•

High-performance optical system.

•

High-resolution CMOS sensor at the distal end.

•

Bright, focused and full-screen monitor images.

•

Optimal flexibility and torsional stiffness of the insertion tube.

•

Optimal illumination of the operation field by integrated LED lighting.

•

Keys for saving images or recording videos when connected to a medical PC with DiVAS installed (in conjunction with a XION EndoCOMPACT).

•

Comparable measurement values with the help of the optional firmly positioned microphone.

All XION Video Nasopharyngoscopes are

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•

Sterilizable by the low-temperature steam and formaldehyde - method (LTSF);

•

Fully immersible in disinfectant solution;

•

CDD-E compatible (cleaning and disinfecting device for endoscopes).

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2.3

Functional Elements The video nasopharyngoscope consists of the insertion tube with bendable distal tip and handle. Located on the handle are the control lever for bending the distal tip, two function keys, an integrated microphone, the connection for the leak tester and/or the ETO ventilation cap.

Figure 1: Functional elements of the EV-NC video nasopharyngoscope

햲

Insertion tube with distal tip (CMOS sensor)

햳

Antikink device for the insertion tube

햴

Control lever for bending the distal tip

햵

Handle

햶

Integrated microphone or reprocessing plug

햷

Function keys Camera button 1 and Camera button 2

햸

Tester connection for the leak tester or the ETO ventilation cap

햹

Camera cable

햺

Camera connector, 14-pin, FGA coding, with protective cap

햻

ETO ventilation cap with instruction label

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2 Product Description

2 1 Figure 2: Plan view of distal tip (cross-section)

12

1

Fibre-optic light guide

2

Lens

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3

Combination and Interaction with Other Devices Use the medical device only as intended in compliance with the relevant “Betreibervorschriften für Medizintechnikprodukte” (German Medical Devices Operator Ordinance - Ordinance on the Installation, Operation and Use of Medical Devices – MPBetreibV) in the system environment delivered and installed by XION GmbH, for which XION GmbH has issued a Declaration of Conformity. Using of the XION Video Nasopharyngoscope outside of the XION system environment does not constitute the intended purpose of the device.

3.1

Compatibilities The XION EV-NC Video nasopharyngoscope is to be used exclusively with •

a XION EndoCOMPACT control unit,

•

a medical monitor in combination with the optional XION Adapter Box, in compliance with the German Betreibervorschriften für Medizinprodukte MPBetreibV (and applicable local or national regulations), see also Chapter "Fields of Application, Indication” on page 5. Using the device assumes compliance with the basic requirements for systems and needs a system conformity declaration when installed.

•

In the system environments supplied and installed by XION GmbH for which a declaration of conformity has been issued by XION GmbH.

To ensure that only components intended for the purpose of the device are connected to each other, the camera connector and the connector sockets of the relevant XION connecting units are equipped with FGA coding.

FGA coding Figure 3: 14-pin camera plug with FGA coding

Caution! With regard to usage and reprocessing, please also refer to the instruction manuals of the medical instruments being used!

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4 Product Application

4

Product Application

4.1

EV-NC Video Nasopharyngoscope and XION Control Unit When you operate the EV-NC Video Nasopharyngoscope in combination with the XION EndoCOMPACT Control Unit, plug the latter's connector into the dedicated connector port on the underside of the control unit, as shown here.

Make sure that the connector markings (red dot) on the connector and the mark on the casing surface are aligned to each other.

Figure 4: Connector port on the control unit

Figure 5: Control unit with connector plug

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4.2

EV-NC Video Nasopharyngoscope and XION Adapter Box To use the EV-NC Video nasopharyngoscope in conjunction with a dedicated medical monitor, a connection must be made via the optional XION Adapter Box (see Chapter 6. 5.2 - Recommended accessories, page 35). The adapter box is used to convert the image data sent by the EV-NC video nasopharyngoscope into a video-compliant signal. The adapter box galvanically isolates all connections to the video nasopharyngoscope, and thus contributes to patient safety.

4. 2.1

Connection to a medical monitor 1

Insert the connector plug of the video nasopharyngoscope into the socket of the adapter box; be sure that the markings (red dot) on the connector plug and the connector socket are aligned to each other.

Figure 6: Adapter box with connector plug

2 Note:

Connect the adapter box to the video input of the dedicated medical monitor.

For further information on using and operating the device, please refer to "Adapter Box for XION Video Nasopharyngoscopes".

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4 Product Application

4.3

Integrated Microphone For voice recordings, or for recording voice memos, and also for synchronization in stroboscopy (see User Manual "XION EndoCOMPACT") the XION EV-NC Video Nasopharyngoscope features an integrated microphone.

4. 3.1

Installing the microphone If your video nasopharyngoscope has a reprocessing plug (for example, due to preceding cleaning/disinfecting), the microphone can be fitted in place of the reprocessing plug.

•

First, unscrew the possibly existing reprocessing plug by turning it counterclockwise, and then pull it out.

Figure 7: Removing the reprocessing stopper

•

Screw the microphone in by turning it clockwise, tighten it hand-tight.

Figure 8: Installing the microphone

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4.4

Function Keys Your XION EV-NC Video Nasopharyngoscope has two function keys.

Camera button 1 Camera button 2

Figure 9: Function keys on the EV-NC video nasopharyngoscope

Which function is triggered by pressing which button depends on the respective system configuration. Possible variations are described below.

4. 4.1

Key functions in a system with an adapter box and a monitor

Camera button 1 Remote signal 100 ms pulse at the control output. REMOTE OUT of the adapter box. Camera button 2 Camera button 1 Camera button 2

ON/OFF Switching the camera on and off When the device is switched off: Short key press 쐀 to switch on When the device is switched on: Press key 2-3 sec. 쐀쐀 to switch off

Figure 10: Key functions in a system with an adapter box and a monitor

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4 Product Application

4. 4.2

Key functions on a system with an EndoCOMPACT

Camera button 1 Start/Stop/Photo in conjunction with XION DiVAS software Start and stop a video recording, trigger a photo capture.

Camera button 1

Camera button 2

Camera button 2

No function

Figure 11: Key functions on a system with an EndoCOMPACT

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5

Reprocessing the Video Nasopharyngoscope

5.1

General The following instructions are based on the: •

Requirements for hygiene when reprocessing flexible endoscopes and supplementary endoscopic instruments

as well as the current • Note:

Recommendations by the commission for hospital hygiene and infection prevention at the Robert-Koch-Institute (RKI)

XION Video Nasopharyngoscopes are compatible with the disinfectants shown in the list in Chapter 8. 1 - Disinfectants, page 37, excerpt from the current List of Disinfectants of the VAH (Verbund für Angewandte Hygiene e.V. (German association of applied hygiene). Below is a description of the reprocessing procedures found to be effective and suitable for XION video nasopharyngoscopes; these procedures are also validated by XION GmbH and therefore recognised as dedicated for their intended purpose.

5. 1.1

General Principles In medical literature, cases of infection and the transfer of pathogens are documented that result from improper cleaning and disinfection or sterilization. For this reason, it is highly recommended to gain a thorough understanding of the reprocessing procedure and to strictly follow the national and local guidelines and principles. One or several persons within the endoscopy department must be specially responsible for the reprocessing of endoscopic equipment. It is recommended to name another trained employee who undertakes this task when the primary responsible person is not present. The persons responsible for reprocessing must be familiar with the following regulations without restriction:

5. 1.2

•

the reprocessing guidelines of your equipment

•

the health and safety regulations concerning industrial law

•

national and local guidelines and regulations for hospitals

•

the contents of this User Manual

•

the mechanical aspects of the endoscopy equipment

•

the relevant identification of germicides

Commissioning The instrument is not in a disinfected or sterilized state before delivery. It is thus essential to disinfect/ sterilize it before its initial use, see Chapter 5. 2 - Recommended Procedure for Complete Reprocessing, page 20.

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5 Reprocessing the Video Nasopharyngoscope

5.2

Recommended Procedure for Complete Reprocessing

End of medical examination

Pre-cleaning Chapter 5. 2.1 - Pre-cleaning, page 21 Transport to reprocessing room

Leak test Chapter 5. 2.2 - Leak test, page 22

Preparatory rigging Chapter 5. 2.3 - Preparatory rigging, page 24

Manual cleaning Chapter 5. 2.4 - Manual cleaning, page 26

Disinfection in RDG-E Chapter 5. 2.7 - Disinfection in CDD-E, page 27

Manual disinfection Chapter 5. 2.5 - Manual disinfection, page 26

Final rinsing, drying and functional test Chapter 5. 2.6 - Final rinsing, drying and functional test, page 27

Sterilization with Steris System 1 Chapter 5. 2.8 - Sterilization with Steris System 1, page 30 or Sterilization in a STERRAD 100 NX (DUO cycle) by means of H2O2 plasma sterilization Chapter 5. 2.9 - Sterilization in STERRAD 100 NX by means of H2O2 plasma sterilization, page 30 or Low-temperature steam formaldehyde (LTSF) Sterilization Chapter 5. 2.10 - Low-temperature steam formaldehyde sterilization (LTSF), page 30

Storage or use

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