KARL STORZ ENDOSKOPE
Fiberscopes in anesthesia Instructions for Use
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Instructions for use Fiberscopes in anesthesia
02-2021 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.
Table of contents
Table of contents 1 General information... 4 1.1 Read the instructions for use ... 4 1.2 Read the instructions for use of combinable products... 4 1.3 Scope... 4 1.4 Description of warning messages... 4 2 Normal use... 5 2.1 Intended use ... 5 2.2 Indications... 5 2.3 Contraindications... 5 2.4 Target user populations ... 5 2.5 Patient groups... 5 3 Safety ... 6 3.1 Unsterile product ... 6 3.2 Correct handling ... 6 4 Product description ... 7 4.1 Product overview ... 7 4.2 Possible combinations... 9 4.3 Symbols on the packaging ... 9 4.4 Ambient conditions ... 10 5 Preparation... 11 5.1 Unpacking the product ... 11 5.2 Testing the product... 11 5.3 Assembling the suction valve ... 11 5.4 Fitting the suction valve ... 11 5.5 Fitting the tube holder... 12 5.6 Connecting the supply lines... 12 5.7 Check for leaks ... 13 6 Application ... 14 6.1 Focusing ... 14 6.2 Suction ... 14 6.3 Introducing instruments ... 14 6.4 Distal tip control ... 14 7 Disassembly... 16 7.1 Disassembling the product ... 16 7.2 Disassembling the suction Valve ... 16 8 Maintenance, servicing, repairs, and disposal... 18 8.1 Repairing the product ... 18 8.2 Disposing of the product ... 18 9 Accessories and spare parts ... 19 9.1 Accessories... 19 10 Subsidiaries... 20
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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General information
1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use carefully and follow all the safety notes and warnings. Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products If the instructions for use of combinable products are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use of the combinable products carefully and follow all the safety notes and warnings.
1.3 Scope These instructions for use are valid for: Article number
Product
11301BN1
Intubation fiberscope 5.2 x 65
11302BD2
Intubation fiberscope 3.7 x 65
11301AA1
Intubation Fiberscope 2.8 x 65
11301CB
Suction valve, reusable
11301CD
Irrigation adapter
11301CF
LIPP tube holder
1.4 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger. WARNING WARNING Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Normal use
2 Normal use 2.1 Intended use Fiberscopes Flexible intubation endoscopes are designed for both endotracheal and nasal intubation. Flexible intubation endoscopes are designed for endoscopic visualization and image transmission as well as for creating an access to introduce additional instruments for diagnosis and treatment of the upper and lower airways. Flexible intubation endoscopes are intended for temporary use in interventions performed through natural orifices. Tube adapter Tube adaptors are used for fastening the ETT on the intubation endoscope. Tube adaptors are non-invasive and are designed for transient or short-term use in invasive procedures through a body orifice or surgically invasive procedures. Cleaning adaptor A cleaning adaptor is used for connecting the existing interfaces of a medical device during reprocessing. Cleaning adaptors do not come into contact with the human body.
2.2 Indications The use of intubation endoscopes is indicated if, in the opinion of the responsible physician, a fiberoptic endotracheal intubation or inspection of the oropharyngeal, supraglottic, or subglottic region is indicated or a percutaneous dilatational tracheostomy (PCT) is performed. This includes, but is not limited to: –
Endotracheal intubation with a difficult respiratory tract
–
Endoscopic inspection and monitoring of the mouth, nose, and throat region
–
Monitoring of percutaneous tracheostomy
–
Anesthesiological bronchoscopy
–
Bronchial lavage
2.3 Contraindications The use of the intubation endoscope is contraindicated if, in the opinion of the responsible physician, the surgical method is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition. Intubation endoscopes must not be used for interventions in direct contact with the central nervous system (CNS) and central cardiovascular system. No other contraindications are known.
2.4 Target user populations The medical device may only be used by doctors and medical assistants with a relevant specialist qualification.
2.5 Patient groups There are no restrictions in terms of patient groups for this product.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Safety
3 Safety 3.1 Unsterile product The product is not sterile when delivered. The use of non-sterile products poses a risk of infection for patients, users, and third parties. Reprocess the product in line with the reprocessing instructions before initial use and every subsequent use.
3.2 Correct handling If the product is not handled correctly, patients, users, and third parties may be injured. Only persons with the necessary medical qualification and who are acquainted with the application of the product may work with it. Check that the product is suitable for the procedure prior to use. Check the product for the following points before and after every use: –
Completeness
–
Good working order
–
Rough surfaces left inadvertently
–
Sharp corners
–
Burred edges
–
Correct assembly of the components
–
Functionality Do not leave broken-off components inside the patient. Do not overload the product with mechanical stress. Do not bend bent products back to their original position.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Product description
4 Product description 4.1 Product overview 2 3
4
1
5
1
Focus ring
4
Instrument channel
2
Suction valve
5
Controls Up/Down
3
Light inlet piece
Suction valve (11301CB)
LIPP tube holder (11301CF)
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Product description
Pressure compensation cap (11025E)
Leakage tester (13242XL)
Irrigation adaptor (11301CD)
Bronchoscope insertion tube (10309)
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Product description
4.2 Possible combinations Fiberscope
Suction valve
Tube holder
Battery light source
Camera heads
11301AA1
091010-01
11301CF
11301D1
11301BN1
11301CB
11301D3
11301BD2
11301CE
11301DE
Compatible with camera heads that are compatible with the ISOTS 18339 interface
11301DF
4.3 Symbols on the packaging Symbol
Meaning Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Batch code
Number of products in the product packaging
Unique Device Identifier
Consult the printed or electronic instructions for use
Unsterile
Fragile, handle with care
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Product description
Symbol
Meaning Not MR safe
Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way
4.4 Ambient conditions Operating conditions Temperature
15 °C - 37 °C
Rel. humidity
15% - 80%
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Preparation
5 Preparation 5.1 Unpacking the product 1.
Carefully remove the product and accessories from the packaging.
2.
Check the delivery for missing items and evidence of shipping damage.
3.
In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.
5.2 Testing the product 1.
Inspect the product for visible contamination. Do not use if contaminated.
2.
Inspect the product for the following characteristics:
–
Good working order
–
Functionality
–
Correct assembly of the components
–
Completeness
5.3 Assembling the suction valve The reusable suction valve 11301CB can be disassembled for reprocessing purposes. To assemble, proceed as follows: 1.
Before assembly, check the sealing rings. Replace any damaged sealing rings.
2.
Attach the sealing ring to cap and tappet.
3.
Insert the tappet, aligned (three guide strips), into the housing and hold in place with your finger.
4.
Place the spring on the top of the housing.
5.
Screw on the cap and tighten gently.
5.4 Fitting the suction valve 1.
Place the suction valve insert on the valve connecting piece and rotate until the side nubs on the insert are positioned above the recesses on the connecting piece.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Preparation
2.
Engage the suction valve insert in the valve connecting piece by applying gentle pressure.
5.5 Fitting the tube holder Push the tube holder onto the fiberscope from distal and fix in place by rotating the two parts in the opposite direction.
5.6 Connecting the supply lines 1.
Connect the light cable to the light inlet nozzle and attach to a light source.
2.
Alternatively, a battery light source can be connected to the light inlet piece. You may need to remove the adaptors 495 G and/or 495 F on the light inlet piece.
Connect the O2 tube to the instrument channel: –
with a LUER lock tube connector (Art. No. 600007) on the instrument channel or
–
if you are using the double stopcock with LUER lock (Art. No. 6927691), connect the tube to the tube holder on the angled part of the adaptor. This keeps the straight opening of the adaptor free for instrumentation.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Preparation
5.7 Check for leaks ATTENTION Penetrating liquid! Product damage! Any ingress of liquid can cause damage to the device. Test for leaks prior to every use. Do not reuse leaking fiberscopes. The leak test must be carried out using the leakage tester in accordance with the instructions in the reprocessing instruction.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Application
6 Application 6.1 Focusing The image is focused with the focus ring.
When connecting the video systems recommended by KARL STORZ , the fiberscope focus ring must be at the zero position (mark).
6.2 Suction Suction can be triggered by pressing the suction valve (when the suction pump is connected and switched on).
There should be no instruments in the suction channel whilst suctioning is being performed. The instrument channel inlet should be sealed to prevent additional air from being drawn in.
6.3 Introducing instruments 1.
Flexible instruments can be inserted through the instrument channel if required.
2.
If you are not using the instrument channel: fit a sealing cap.
6.4 Distal tip control Control the upward/downward movement of the fiberscope's distal tip by moving the Up/ Down control in the direction required. Move the control smoothly and slowly.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Application
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Disassembly
7 Disassembly 7.1 Disassembling the product 1.
Rotate the two parts in the opposite direction to release the tube holder and pull it off the fiberscope.
2.
Remove the O2 tube from the instrument channel.
3.
Remove the light cable or battery light source from the light inlet piece.
4.
Rotate the suction valve to release it and then pull it off the suction valve.
7.2 Disassembling the suction Valve 1.
Unscrew the cap, pull off the spring.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Disassembly
2.
Remove the sealing ring from the cap and the tappet.
3.
Check the sealing rings. Replace any damaged sealing rings.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Maintenance, servicing, repairs, and disposal
8 Maintenance, servicing, repairs, and disposal 8.1 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products.
8.2 Disposing of the product For disposal, the following measures are necessary: 1.
Decontaminate the products prior to disposal.
2.
Country-specific national laws and regulations must be observed.
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Accessories and spare parts
9 Accessories and spare parts 9.1 Accessories Item
Order no.
Adapter for two-way stopcock, LUER lock with O2 tube connection
6927691
Cleaning brush, for 1.2 mm instrument channel
27651A
Cleaning brush, for 1.8-2.6 mm instrument channel
27651B
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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Subsidiaries
10 Subsidiaries KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Postfach 230, 78503 Tuttlingen/Germany Phone: +49 7461 708-0 , Fax: +49 7461 708-105 Email: [email protected]
KARL STORZ SE & Co. KG Representation Office Kęstučio st. 59 / Lenktoji st. 27, 08124 Vilnius, Lithuania Phone: +370 5 272 0448, Mobile: +370 685 67 000 Email: [email protected]
KARL STORZ Endoskope Berlin GmbH Scharnhorststr. 3, 10115 Berlin/Germany Phone: +49 30 3069090, Fax: +49 30 30 19452
KARL STORZ Endoskopi Danmark A/S Skovlytoften 33, 2840 Holte, Denmark Phone: +45 45162600, Fax: +45 45162609 Email: [email protected]
KARL STORZ Endoscopy Canada Ltd. 7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada Phone: +1 905 816-4500, Fax: +1 905 816-4599 Toll free (Canada only) Phone: 1-800-268-4880, Fax: 1-800-482-4198 (Canada only) Email: [email protected] KARL STORZ Endoscopy-America, Inc. 2151 East Grand Avenue, El Segundo, CA 90245-5017, USA Phone: +1 424 218-8100, Fax: +1 424 218-8525 Toll free (USA only) Phone: 800 421-0837, Fax: 800 321-1304 (USA only) Email: [email protected] KARL STORZ Veterinary Endoscopy-America, Inc. 1 South Los Carneros Road, Goleta, CA 93117, USA Phone: +1 805 968-7776, Fax: +1 805 685-2588 Email: [email protected] KARL STORZ Endoscopia Latino-America, Inc. 815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA Phone: +1 305 262-8980, Fax: +1 305 262-8986 Email: [email protected] KARL STORZ Endoscopia México S.A. de C.V. Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna, Cuba Phone: +537 836 95 06, Fax: +537 836 97 76 Email: [email protected] KARL STORZ Endoscopia México S.A. de C.V. Av. Ejercito Nacional No. 453 Piso 2, Colonia Granada, Alcaldia Miguel Hidalgo, C.P. 11520 Ciudad de México Phone: +52 (55) 1101 1520 Email: [email protected] KARL STORZ Marketing América Do Sul Ltda. Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São Paulo, Brasil Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 Email: [email protected] KARL STORZ Endoscopia Argentina S.A. Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de Buenos Aires, Argentina Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 Email: [email protected] KARL STORZ Endoskopi Norge AS Stamveien1, 1483 Hagan, Norway Phone: +47 6380 5600, Fax: +47 6380 5601 Email: [email protected] KARL STORZ Endoskop Sverige AB Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +46 8 505 648 00 Email: [email protected] KARL STORZ Endoscopy Suomi OY Taivaltie 5, 01610 Vantaa, Finland Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: [email protected]
KARL STORZ Endoscopy (UK) Ltd. 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom Phone: +44 1753 503500, Fax: +44 1753 578124 Email: [email protected] KARL STORZ Endoscopie Nederland B. V. Displayweg 2, 3821 BT Amersfoort, Netherlands Phone: +31 (0)33 4545890 Email: [email protected] KARL STORZ Endoscopy Belgium N. V. Phone: +31 (0)33 4545890 Email: [email protected] KARL STORZ Endoscopie France S. A. S. 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Phone: +33 1 30484200, Fax: +33 1 30484201 Email: [email protected] KARL STORZ Endoskop Austria GmbH Landstraßer Hauptstr. 148/1/G1, 1030 Wien, Austria Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479 Email: [email protected] KARL STORZ Endoscopia Ibérica S. A. Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830 Madrid, Spain Phone: +34 91 6771051, Fax: +34 91 6772981 Email: [email protected] KARL STORZ Endoscopia Italia S. r. l. Via dell’Artigianato, 3, 37135 Verona, Italy Phone: +39 045 8222000, Fax: +39 045 8222001 Email: [email protected] KARL STORZ Croatia d.o.o. Capraška 6, 10000 Zagreb, Croatia Phone: +385 1 6406 070, Fax: +385 1 6406 077 Email: [email protected] KARL STORZ Endoskopija d.o.o. Cesta v Gorice 34b, 1000 Ljubljana, Slovenia Phone: +386 1 620 5880, Fax: + 386 1 620 5882 Email: [email protected] KARL STORZ Polska Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Email: [email protected] KARL STORZ Endoszkóp Magyarország Kft. Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary Phone: +36 195 096 31, Fax: +36 195 096 31 Email: [email protected] KARL STORZ Endoscopia Romania srl Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bukarest, Romania Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801 Email: [email protected] KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: [email protected] *Repair & Service Subsidiary
Instructions for use • Fiberscopes in anesthesia • KFC618_EN_V1.0_02-2021_IFU_CE-MDR
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