C-MAC Video Laryngoscope Series 8403 Instructions for Use V1.0

04-2021 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... 5 1.1 Read the instructions for use ... 5 1.2 Read the instructions for use of combinable products... 5 1.3 Scope... 5 1.4 Description of warning messages... 6 2 Normal use... 7 2.1 Intended use ... 7 2.2 Indications for use... 7 2.3 Contraindications... 7 2.4 Target user populations ... 7 2.5 Patient groups... 7 3 Safety ... 8 3.1 Serious incidents ... 8 3.2 Correct handling ... 8 3.3 Unsterile product ... 8 3.4 Damaged products ... 8 3.5 Combination with other components ... 9 3.6 Electromagnetic interference ... 9 3.7 Patient leakage current ... 10 3.8 National guidelines on airway management ... 10 3.9 Hot components ... 10 3.10 High light intensity ... 10 4 Product description ... 11 4.1 Product overview ... 11 4.2 Possible combinations... 12 4.3 Technical specifications... 12 4.4 Symbols employed ... 13 4.4.1 Symbols on the packaging ... 13 4.4.2 Symbols on the product ... 14 4.5 Ambient conditions ... 14 5 Preparation... 15 5.1 Unpacking the product ... 15 5.2 Testing the product... 15 5.2.1 Visual inspection... 15 5.2.2 Functional test ... 17 5.3 Connecting the C-MAC® Monitor ... 17 5.4 Connecting the C-MAC® Pocket Monitor ... 19 5.5 Connecting C-Hub® II ... 20 6 Application ... 21 6.1 Using the product ... 21 6.2 Inserting an oxygen or suction catheter ... 21 7 Disassembly... 23 7.1 Disassembling the product ... 23 8 Maintenance, servicing, repairs, and disposal... 24 8.1 Repairs to the product ... 24 8.2 Disposing of the product ... 24 9 Accessories and spare parts ... 25 9.1 Accessories... 25 10 Electromagnetic compatibility... 26 10.1 Electromagnetic compatibility ... 26

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Table of contents

11 Fault correction ... 27 11.1 Product malfunctions... 27 12 Subsidiaries... 28

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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 the following products: Product

Item number

C-MAC® Video Laryngoscope

8403AX 8403AXC 8403BX 8403BXC 8403HX 8403DXC 8403EXC 8403GXC 8403KXC 8403MXC 8403HXP 8403NXC

Video connecting cable

8403X

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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General information

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. NOTICE ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Normal use

2 Normal use 2.1 Intended use Video laryngoscopes (CMOS) are used for visualizing the respiratory tracts and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video laryngoscopes (CMOS) are designed for transient use in invasive procedures through a body orifice. C-MAC® Monitor accessories are used for transmitting energy. C-MAC® Monitor accessories are used in conjunction with the C-MAC® System for visualizing the respiratory tracts and vocal cords during endotracheal intubation and for inspecting and examining the upper respiratory tract. C-MAC® Monitor accessories are non-invasive and are designed for transient use in invasive procedures through a body orifice.

2.2 Indications for use The use of laryngoscopes and video laryngoscopes is indicated if, in the opinion of the responsible physician, inspection of the upper respiratory tract or endotracheal intubation is indicated.

2.3 Contraindications The use of laryngoscopes and video laryngoscopes is contraindicated if, in the opinion of the responsible physician, use is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition. Laryngoscopes and video laryngoscopes must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system.

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 • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Safety

3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): –

Death of a patient, user, or another person

–

Temporary or permanent serious deterioration in the medical condition of a patient, user, or another person

–

A serious threat to public health The manufacturer and appropriate authority must be notified of all serious incidents.

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.

3.3 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.

3.4 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the product for damage. Do not use damaged products.

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Safety

3.5 Combination with other components The use of unauthorized devices and components or unauthorized changes to the product can result in injuries. Additional devices connected to electrical medical equipment must comply with the relevant IEC or ISO standards. Furthermore, all configurations must comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1). Only combine the product with devices and components that are approved for joint use by the manufacturer. Comply with national and local regulations. Observe the instruction manuals and interface specifications of the devices and components used in combination. Only use devices and components that have standardized interfaces and do not breach the intended use of the product. Only make changes to the product if these changes are approved by KARL STORZ.

3.6 Electromagnetic interference Medical electrical products are subject to special precautions regarding electromagnetic compatibility and must be installed and commissioned according to the tables on electromagnetic compatibility. If other products (e.g. for MRT, CT, diathermy, electrocautery, or RFID) emit electromagnetic radiation, the function of the product may be impaired. Highfrequency communication equipment can affect electrical medical products and impair their performance. Do not use the product in the vicinity of a magnetic resonance tomograph (MRT). Do not use the product next to or together with other devices. If such use is required, monitor the product and the other devices, and follow the relevant instructions for use in the event of malfunctions. Portable RF communications equipment including peripheral devices (e.g., antenna cables and external antennas) should be used no closer than 30 cm from the product, including cables specified by the manufacturer. Observe the information on electromagnetic compatibility; see chapter Electromagnetic compatibility [p. 26]. In case of uncertainties, seek expert advice from KARL STORZ. Before use, a clinical/biomedical engineer or an EMC specialist should carry out an ad-hoc test of the electromagnetic radiation. The use of accessories and cables other than those specified in the instruction manual may result in increased emissions or decreased immunity of the product. When using other accessories and cables, the operator is responsible for checking compliance with IEC 60601-1-2 for this particular product. To prevent increased electromagnetic emissions or reduced electromagnetic immunity of the product, only use accessories, transducers, and cables recommended or supplied by the manufacturer.

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Safety

3.7 Patient leakage current Patient leakage currents from products may add up if powered endoscopes and powered endotherapy devices are used simultaneously. Excessively high leakage current levels may result in the patient becoming injured. Only use products of the same type together; e.g., CF.

3.8 National guidelines on airway management Failure to observe the national guidelines on airway management may put the patient at risk. National guidelines on airway management must be observed in addition to the documentation accompanying the product.

3.9 Hot components The high level of light intensity may cause the distal end, the light connections for the endoscope and fiber optic light cable, and adjacent components to heat up. This can cause burns to patients, users, or third parties. The high level of light intensity may cause the distal end of the endoscope to heat up. This can cause burns to patients, users, or third parties. Set the light source output to a level that is just high enough to ensure optimal illumination of the operating area. Avoid contact with the distal end and light connections of the endoscope and fiber optic light cable. Avoid contact with the distal end of the endoscope.

3.10 High light intensity The high level of light intensity produced by the light source may lead to permanent eye damage or blindness, and may cause tissue and items facing the light output to heat up. Do not look into the light output. Set the light source output to a level that is just high enough to ensure optimal illumination of the operating area. Make sure the light output is sufficiently far away from tissue and operating accessories.

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview

1 2

Video laryngoscope (8403AXC/BXC/DXC/GXC/KXC/MXC/HXP) without guidance for suction catheter 1

Socket for video connecting cable

2

Multifunction button

Video laryngoscope (8403EXC) without guidance for suction catheter

Video laryngoscope (8403AX/BX/HX) with guidance for suction catheter

1

2

Video connecting cable (8403X) 1

Laryngoscope connection socket

2

Monitor connection socket

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Product description

4.2 Possible combinations The C-MAC® Video Laryngoscopes from series 8403 can be operated with the following monitors: –

C-MAC® Monitor 8403ZX (software version: 704v300 or higher)

–

C-MAC® Monitor 8404ZX

–

C-MAC® Pocket Monitor 8403XD

–

With other monitors via the camera control unit C-HUB® II (20290320) (software version: 721v105 or higher)

The C-MAC® Video Laryngoscopes from series 8403 can be combined with the following catheters: –

Blade 8403AX with 14 Fr. and 16 Fr. catheters

–

Blade 8403HX and 8403BX with 16 Fr. and 18 Fr. catheters

4.3 Technical specifications Video laryngoscope 8403AX/BX/HX/AXC/BXC/KXC/HXP Designation

Value

Immersion protection

IPX8

Camera technology

CMOS

Resolution

640 x 480

Illumination:

LED, white, 1 W

Video laryngoscope 8403AX/BX/HX/AXC/BXC/KXC/HXP serial number 80.000 and higher Designation

Value

Immersion protection

IPX8

Camera technology

CMOS

Resolution

300 x 400

Illumination

LED, white, 1 W

Video laryngoscope 8403DXC/EXC/GXC/MXC/NXC Designation

Value

Immersion protection

IPX8

Camera technology

CMOS

Resolution

300 x 400

Illumination

LED, white, 1 W

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Product description

4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol

Meaning Number of products in the product packaging

Article no.

CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body. Consult instructions for use

Manufacturer

Serial number

Keep dry

Keep away from sunlight

Temperature limit

Date of manufacture

In accordance with US federal law (21 CFR 801.109), this product may only be sold to or on prescription from a licensed physician. Not MR safe

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Product description

4.4.2 Symbols on the product Symbol

Meaning Follow instructions for use

Type BF device

Serial number

CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body.

4.5 Ambient conditions Storage/transport conditions Temperature

-20°C ...+50°C

Relative humidity (non-condensing)

5–95%

Operating conditions Temperature

0°C ...40°C

Relative humidity (non-condensing)

30–70%

Air pressure

700–1,080 hPa

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_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 5.2.1 Visual inspection Missing components, surface changes, or other damage limit the life span of the product and may mean that the product can no longer be used for its intended use. 1.

The product must be inspected for completeness, damage, and integrity before and after every use. Inspection tools such as magnifying glasses should be used as necessary.

2.

Check for the following types of mechanical damage and changes:

–

Sharp corners

–

Burred edges

–

Rough surfaces

–

Protruding or bent parts

1 Defect pattern: Blade tip bent

Defect pattern: Blade roof bent 3.

Check the product for rust and corrosion.

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Preparation

4.

Check whether the coating is damaged.

Defect pattern: Poor general condition 5.

Ensure that the components and connections are complete, intact, and positioned correctly.

6.

Check whether there are residues and/or moisture at the interfaces.

7.

Check the mobility of the components. Instruments that can be dismantled should be assembled for this purpose.

8.

Use a magnifying glass to check that the telescope is complete, intact, and securely positioned.

Defect pattern: Upper glass missing

Defect pattern: Lower glass broken

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Preparation

5.2.2 Functional test Inspect the product for the following characteristics: –

Fully functional control keys

–

Securely positioned connecting cable

–

Functional image transmission

–

Sufficient image quality

–

Light transmission

5.3 Connecting the C-MAC® Monitor 1.

Insert the video connecting cable into the socket of the video laryngoscope. Pay attention to the orientation pin on the plug and socket.

2.

Make sure that the cable is fully inserted.

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Preparation

3.

Connect the other end of the video connecting cable to the socket on the C-MAC® Monitor.

4.

Alternatively, connect the other end of the video connecting cable to the socket on the rear side.

Another laryngoscope can be connected during use.

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Preparation

5.4 Connecting the C-MAC® Pocket Monitor The Pocket Monitor can be connected to the product while folded up or down. 1.

Connect the C-MAC® Pocket Monitor to the socket of the video laryngoscope. Pay attention to the orientation pin on the plug and socket.

2.

Make sure that the lugs of the plug connection are opposite each other and the plug is fully inserted. ð As soon as the photo/video recording function is ready, the multifunction button lights up blue.

ð The video laryngoscope is ready for operation.

The monitor can be removed and connected to another laryngoscope during use.

Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR

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Preparation

5.5 Connecting C-Hub® II 1.

Connect the video connecting cable to the socket on the product. Pay attention to the orientation pin on the plug and socket.

2.

Make sure that the cable is fully inserted.

3.

Connect the power supply unit to the C-HUB® II.

4.

Connect the video connecting cable to the video input on the front of the C-HUB® II.

5.

Connect the monitor to the S-Video output or HDMI output on the rear of the C-HUB® II.

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