XION
XN HD Video Nasopharyngoscope 329 3xx 401 User Manual Nov 2017
User Manual
48 Pages
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XN HD Video Nasopharyngoscope XION Article Number 329 3xx 401
User Manual
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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XION GmbH Pankstraße 8 13127 Berlin GERMANY
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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 Contraindication ... 5 Directions for Using the Manual ... 5 Explanation of the Graphic Symbols Used ... 6 1
Safety Precautions ... 8
1.1
Safety Measures ... 8
1.2
Electromagnetic Compatibility (EMC) ... 10
2
Product Description ... 11
2.1
Scope of Delivery ... 11
2.2
Properties ... 12
2.3
Functional Elements ... 13
3
Combination and Interaction with Other Devices ... 15
3.1
Compatibilities ... 15
3.2
Built-in Microphone and Clip Microphone ... 15
4
Product Application ... 16
4.1
Connector and Cable ... 16
4.2
Integrated Microphone ... 17
4.2.1
Installing the microphone ... 17
4.3
Function Keys ... 18
4.4
Functional Test ... 19
4.4.1
Visual inspection ... 19
4.4.2
Function test ... 20
4.5
Establish Plug Connection ... 21
4.6
Releasing the Spectar Connector from the Control Unit ... 22
4.6.1
White balancing ... 22
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4
5
Reprocessing the XN HD Video Nasopharyngoscope ... 23
5.1.1
Guidelines for reprocessing ... 23
5.1.2
Material durability ... 24
5.1.3
Restrictions in reprocessing ... 24
5.2
Recommended Reprocessing Steps ... 25
5.2.1
Pre-cleaning ... 26
5.2.2
Leak test ... 27
5.2.2.1
Checking the leak tester ... 27
5.2.2.2
Performing a leak test ... 28
5.2.3
Disassembly ... 29
5.2.4
Microphone, cleaning/disinfecting ... 30
5.2.5
Manual cleaning ... 30
5.2.6
Manual disinfection ... 30
5.2.7
Final rinsing and drying ... 31
5.2.8
Assembly ... 32
5.2.9
Visual and functional inspection ... 32
5.2.10
Disinfection in a CDD-E ... 32
5.2.11
Packaging ... 34
5.3
Sterilization ... 34
5.3.1
Sterilization with Steris System 1 ... 35
5.3.2
LTSF Sterilization ... 35
5.4
Storage/Keeping ... 36
5.4.1
General principles ... 36
5.4.2
Requirements for proper storage ... 36
6
Maintenance and Service ... 37
6.1
User Maintenance ... 37
6.1.1
General ... 37
6.1.2
Transport ... 37
6.2
Manufacturer's Service ... 38
6.2.1
Service address ... 38
6.3
Returns ... 40
6.4
Disposal ... 40
6.5
Spare Parts and Accessories ... 41
6.5.1
Spare parts ... 41
6.5.2
Recommended accessories ... 41
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Technical Data ... 42
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Declarations Concerning EMC ... 43 Guidelines and manufacturer declaration ... 43 Electromagnetic environment ... 43 Tested lines according to IEC 60601-1-2 : 02.2014 ... 43
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Troubleshooting ... 44
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Treatment Chemicals ... 45
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Manufacturer and Distributor ... 46 List of Figures ... 47
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Important Information – Please read before use Intended Purpose The flexible XN HD Video Nasopharyngoscope is a high-end medical device. It serves as a tool for endoscopic examinations of the nasal pharynx, nasal cavities and trachea, and is used for stroboscopic observations of the larynx. It can be used to illuminate the examination-situs – for both pure diagnostics as well as for stroboscopic examinations. 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 XN HD Video Nasopharyngoscope can be used in diagnostic and surgical medical disciplines. The integrated microphone makes this device particularly suitable for laryngo-stroboscopy. The XN HD Video Nasopharyngoscope can be operated in combination with XION's Control Units MATRIX Spectar and EndoSTROBE Spectar, see also Chapter 3. 1 - "Compatibilities", page 15.
Warning! XION Video Nasopharyngoscopes must be used only for the described purpose and in the described manner.
Contraindication Contraindications that relate directly to the medical device, are currently unknown. The responsible physician must decide on the basis of the general condition of the patient, whether the intended application can be made.
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", page 8. 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.
This User Manual does not include any detailed description of endoscopy and is also not suitable for introducing beginners to this surgical technique!
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Explanation of the Graphic Symbols Used To provide a better overview, the following drawings or graphic symbols are used in the text, on the product or on the packaging:
Symbol
Meaning Before using the instruments, read the User Manual. Make sure that the User Manual is always within reach.
Warning!
The safety of the patient, user or a third person is at risk! To avoid injuries to the patient, user or any third person, make sure to observe this warning.
CAUTION!
Indicates situations where failure to observe may jeopardize operational safety or damage equipment.
Note:
Recommends actions for improving situations and enhancing operational safety, however failure to observe these recommendations does not lead to failures or damage. Manufacturer information
Year of manufacture 201x
Temperature limits for storage and use
Rel. humidity
Air pressure for transportation
Keep dry
Caution; fragile
IP 67
Degree of protection against moisture and solids entering the device
Class BF application part
Article number
Serial number
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Symbol
Meaning Disposal considerations
Useful Information:
CE marking with the number of the notified body.
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1 Safety Precautions
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Safety Precautions
1.1
Safety Measures • Use the XN HD Video Nasopharyngoscope only according to its intended purpose as to the standards and regulations applicable in the respective country of use, the common state of the art, and in accordance with the prevailing labour protection and accident prevention rules. The instrument shall be used only by medical personnel and physicians who, through their specialist qualifications, can ensure that the device is handled in the proper manner. • Connect and operate the XN HD Video Nasopharyngoscope only under the conditions specified in the Technical Data (Chapter 7 - "Technical Data", page 42)!
Before using the Video Nasopharyngoscope: • Visually inspect the device to ensure its functional safety and proper working condition. Do not use the XN HD Video Nasopharyngoscope if you detect any damage that could jeopardize the patient, the user, or third persons. • Each time before you use the instrument, perform a complete functional test as described in this User Manual in Chapter 4. 4 - "Functional Test", page 19. • The XN HD Video Nasopharyngoscope 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. • The XN HD Video Nasopharyngoscope is not suitable for operating in MRI rooms.
Notes on using the Video Nasopharyngoscope: • It is essential to ensure that the XN HD Video Nasopharyngoscope is properly connected before it can be used as an application part! • When introducing and removing the XN HD 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. • When removing the XN HD Video Nasopharyngoscope from the body orifice/body cavity, it is essential to first ensure that the distal end is in a relaxed state (the distal tip must not be angled/bent on removal). • The XN HD 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 62°C, and mechanical stress such as shocks and sharp bending of the insertion shaft. • In the vicinity of the endoscope, be careful with pointed or sharp objects such as scalpels or needles.
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Warning: Avoid high increases in temperature! • High-energy endoscopic light can exit from the fibre-optic output of the XN HD 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. It must be ensured that the light exit at the distal tip of the insertion shaft is not contaminated, since otherwise there is a risk of dangerous heating above 41°C for the patient. • Always avoid direct contact with tissue in the light emission area!
Warning: Risk of fire! • The high level of light energy radiated at the distal end may give rise to high temperatures or fire if the XN HD Video Nasopharyngoscope is placed on heat-sensitive or flammable surfaces. Therefore, always place the XN HD Video Nasopharyngoscope in suitable receptacles. • The fibre-optic output must not be placed directly onto the body or on any inflammable materials.
Cautious and careful work is the best protection against accidents! • The medical device's operational reliability and availability depend not only on your ability, but also on the maintenance provided. Regular cleaning and maintenance are imperative (see Chapter 5 - "Reprocessing the XN HD Video Nasopharyngoscope", page 23). • When reprocessing the XN HD Video Nasopharyngoscope and accessories, use only the cleaning agents and disinfectants 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.
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1 Safety Precautions
1.2
Electromagnetic Compatibility (EMC) • As a component of the XION Spectar System, the XN HD Video Nasopharyngoscope meets the requirements of IEC 60601-1-2/02.2014 (CISPR 11, Group 1, Class B). • The essential performance features - uninterrupted image display and uninterrupted operability - were successfully tested for their electromagnetic compatibility. EM disturbances greater than the ones prescribed for the test procedure may affect both the image representation as well as the operability. • Mobile RF communications equipment (radios including their accessories such as antenna cables and external antennae) should NOT be used at a distance of less than 30 cm from the components identified by XION and the conductor lines of the Spectar System. Failure to observe this requirement can significantly reduce the performance of the device. • 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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Product Description
2.1
Scope of Delivery • XN HD Video Nasopharyngoscope Art. No. 329 309 401
or XN HD Video Nasopharyngoscope with Olympus Valve Art. No. 329 309 401OLY
• Microphone for Video Nasopharyngoscopes a Art. No. 327 009 020 (already inserted) • Reprocessing plug b for microphone connection Art. No. 327 009 006
• ETO ventilation cap with instruction label Art. No. 130 009 010
• Leak tester for fibre-optic endoscopes Art. No. 130 009 012
• Connector kit for CDD-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 38). Please check the goods for completeness and integrity.
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2 Product Description
2.2
Properties •
Image resolution quality comparable to HD
•
High-contrast images with high level of detail accuracy
•
Connected to the control unit via a single cable
•
Ergonomic and symmetrically shaped handle
•
Programmable function keys
•
Suitable for both machine and/or manual reprocessing
•
Ideal for use in stroboscopy and swallowing diagnostics
All XION Video Nasopharyngoscopes are
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•
sterilizable using 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 XN HD Video Nasopharyngoscope consists of the insertion shaft with distally bendable tip, and the handle. Located on the handle are the control lever for bending the distal tip, two function keys, an integrated microphone, the connection port for the leak tester and/or the ETO ventilation cap, as well as the combined connector cable with the Spectar Connector.
Figure 1: Functional elements of the Video Nasopharyngoscope
a
Insertion shaft with distal tip (CCD sensor)
b
Anti-kink device for the insertion shaft
c
Control lever for bending the distal tip
d
Tester connector for the leak tester or the ETO ventilation cap
e
Handle
f
Integrated microphone
g
Reprocessing plug
h
Function keys Camera button 1 and Camera button 2
i
Kink protector for the connecting cable
j
Connector cable
k
Spectar Connector
l
ETO ventilation cap with instruction label
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2 Product Description
Figure 2: Plan view of distal tip
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1
Fibre-optic light guide
2
Lens
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Combination and Interaction with Other Devices The XN HD Video Nasopharyngoscope does not have its own power supply and can not be connected to the mains supply. It can only be operated in conjunction with XION Spectar Camera Control units. Use the medical device only as intended in accordance with applicable regulations and the intended use. Using the Video Nasopharyngoscope outside of the XION system environment does not constitute the intended purpose of the device. Observe the respectively applicable national regulations and laws! When used in conjunction with the intended camera control unit, the XN HD Video Nasopharyngoscope meets the requirements for Class BF devices.
3.1
Compatibilities The XION XN HD Video Nasopharyngoscope must be used with the following XION devices: • MATRIX P Spectar • MATRIX E Spectar • EndoSTROBE PL Spectar • EndoSTROBE EL Spectar respectively in the system environments supplied and installed by XION GmbH for which a declaration of conformity has been issued by XION GmbH.
3.2
Built-in Microphone and Clip Microphone The XN HD Video Nasopharyngoscope is equipped with a built-in microphone for voice recording or for synchronization in stroboscopic applications. If both the XN HD Video Nasopharyngoscope and the Clip Microphone are connected to one and the same MATRIX Spectar Control Unit at the same time, the Control Unit will switch off the integrated microphone of the Video Nasopharyngoscope, so that only the Clip Microphone will be available for voice recording.
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4 Product Application
4
Product Application
Warning! The XN HD Video Nasopharyngoscope is delivered in a non-sterile condition! Before using the device the first time and also before each subsequent use on a patient, it must be properly disinfected / sterilized, as described in Chapter 5 - Reprocessing the XN HD Video Nasopharyngoscope, from page 23. Warning! Before each use on the patient, the XN HD Video Nasopharyngoscope with all its components must be thoroughly checked for integrity and proper operation. In the event of any discovered or suspected defects, DO NOT use the device (see also Chapter 4. 4 - "Functional Test", page 19)!
4.1
Connector and Cable The connection between the XN HD Video Nasopharyngoscope and a XION Spectar Control Unit is established by means of a Spectar Connector plug connection.
Warning! Before each use, visually inspect the Spectar Connector for damage (particularly on the board), as described below. If the cable and/or the plug connector are damaged, consult your XION service team, see Chapter 6. 2 - "Manufacturer's Service", page 38. CAUTION During the entire operation (installation, usage, processing, packaging, etc.) it must be ensured that the connecting cables used are never subjected to any excessive stress by pulling A, torsion B (twisting) or kinking C, because this could damage or even destroy the cables!
Figure 3: Avoid damage to cables
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4.2
Integrated Microphone The XN HD Video Nasopharyngoscope features an integrated microphone, which can be used for voice recordings, or for recording voice memos, and also for synchronization in stroboscopy.
4. 2.1
Installing the microphone If your Video Nasopharyngoscope has a reprocessing plug plugged into it (for example, due to preceding cleaning/disinfecting), this reprocessing plug can be removed to fit the microphone in its place.
• First, unscrew the reprocessing plug (if installed) by turning it counter-clockwise, and then pull it out.
Figure 4: Removing the reprocessing plug
• Screw the microphone in by turning it clockwise, tighten it hand-tight.
Figure 5: Installing the microphone
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4 Product Application
4.3
Function Keys Your XN HD Video Nasopharyngoscope has two function keys.
Camera button 1 Camera button 2
Figure 6: Function keys
Which function is triggered by pressing a button will depend on the respective system configuration.
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For detailed descriptions of the functions available, please refer to the user manual of the Control Unit to which your Video Nasopharyngoscope is connected.
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4.4
Functional Test Warning!
4. 4.1
Each time before using the Video Nasopharyngoscope on a patient, it is essential to first perform a visual inspection and a functional test!
Visual inspection •
Check the Video Nasopharyngoscope for integrity, wear and hygienic condition.
•
Verify the integrity of the entire surface of the flexible shaft. Ensure that there are no discernible kinks, twists or other irregularities.
•
Use a cotton swab to wipe the entire insertion shaft, to ensure that no metal wires or fibres have penetrated its sleeve.
•
Hold the device as shown here. Bend the flexible insertion shaft, and make hand movements in the direction indicated by the arrow. Make sure that the insertion shaft shows continuous elasticity, and can be smoothly bent into a semicircle.
Cotton swab
Figure 7: Examining the insertion shaft
•
Make sure that the flexible material of the insertion shaft is not deformed or compressed at any point, as exemplified in Figure 14 "Handle the insertion shaft with care", page 26. In the event that deficiencies are detected, please proceed as described in the corresponding chapter in section Special care when cleaning the insertion shaft: on page 26.
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