KARL STORZ C-MAC Video Laryngoscope 8403xxx Instruction For Use V4.3 Dec 2019

12/2019 © KARL STORZ It is not permitted to forward or reproduce this document or to use or disclose the contents thereof unless express consent is given. Publisher KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Tel.: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: [email protected] www.karlstorz.com

Table of contents

Table of contents 1 General information... 5 1.1 Reading the instructions for use ... 5 1.2 Scope... 5 2 Product description ... 6 2.1 Product overview ... 6 2.2 Packaging symbols... 8 2.3 Symbols on the product ... 8 3 Intended use ... 9 3.1 Intended purpose... 9 3.2 Contraindications... 9 3.3 Target user populations ... 9 3.4 Training in the operation and function of the device ... 9 3.5 Target patient populations ... 9 3.6 User qualifications ... 9 4 Safety ... 11 4.1 Serious incidents ... 11 4.2 Description of warnings ... 11 4.3 Notes on use... 11 4.4 Unsterile instruments ... 11 4.5 Correct reprocessing ... 11 4.6 Risks from electric current ... 12 4.7 Risks due to damaged parts... 12 4.8 Damaged products ... 12 4.9 Combination with other devices and accessories ... 12 4.10 Damage to the instrument ... 12 5 Installation and commissioning... 14 5.1 Visual and functional test... 14 5.2 Initial operation ... 15 6 Application ... 17 6.1 Connection to the C-MAC® monitor ... 17 6.2 Connection to the C-MAC® pocket monitor ... 18 6.2.1 Switching on the "Open-to-Intubate (OTI) displays" ... 19 6.2.2 Switching off the "Open to intubate" (OTI)-Displays ... 20 6.3 Connection to the C-Hub® II ... 21 6.4 Multifunctional button of the video laryngoscope ... 22 6.4.1 Color coding meanings for the "Blue Button" multifunction button ... 23 6.4.2 Single image capture ... 23 6.4.3 Video recording ... 23 6.4.4 Insertion of an oxygen or suction catheter (only with 8403 AX/BX/HX)... 24 6.5 Disassembly... 24 7 Reprocessing ... 25 7.1 Overview table (worldwide, does not apply to USA and Canada) ... 25 7.2 General warnings (worldwide, does not apply to USA and Canada)... 25 7.3 Preparation for cleaning and disinfection ... 27 7.4 Brushing the surfaces ... 27 7.5 Manual cleaning ... 27 7.6 Manual disinfection ... 27 7.7 Machine cleaning and disinfection ... 27 7.8 Assembly, inspection and care... 28 7.9 Packaging ... 28

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Table of contents

7.10 Sterilization ... 28 7.10.1 Hydrogen peroxide (H₂O₂) sterilization - ASP STERRAD® ... 28 7.10.2 Hydrogen peroxide (H₂O₂) sterilization - STERIS® AMSCO® V-PRO™ 1 ... 29 7.10.3 Ethylene oxide sterilization (EO) ... 29 7.10.4 Chemical low-temperature sterilization with peracetic acid – STERIS® - System 1® ... 29 7.10.5 Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E® ... 29 7.11 Reprocessing limits... 30 8 Reprocessing USA and Canada ... 31 8.1 Overview table ... 31 8.2 General warnings (applies only to USA and Canada) ... 31 8.3 Brushing the surfaces ... 32 8.4 Water Quality Requirements ... 32 8.5 Pre-cleaning... 32 8.6 Manual cleaning ... 32 8.7 Assembly, inspection and care... 33 8.8 Packaging ... 33 8.9 Sterilization ... 33 8.9.1 Hydrogen peroxide (H₂O₂) sterilization - ASP STERRAD® ... 33 8.9.2 Hydrogen peroxide (H₂O₂) sterilization - STERIS® AMSCO® V-PRO™ ... 34 8.9.3 Ethylene oxide sterilization (EO) ... 34 8.9.4 Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E® ... 35 8.10 High-level disinfection... 36 8.11 Reprocessing limits... 36 9 Service and repair ... 37 9.1 Servicing and repair program ... 37 9.2 Complaint shipments ... 37 10 Limitation of Liability ... 38 11 Guarantee ... 39 12 Electromagnetic compatibility... 40 13 Standards, directives and regulations ... 41 13.1 Standards, directives and regulations ... 41 13.2 Standard compliance... 41 14 Disposal ... 42 15 Technical specifications... 43 16 Fault correction ... 44 16.1 Troubleshooting ... 44 17 Accessories and spare parts ... 46 17.1 Accessories... 46 18 Subsidiaries... 47

Instruction For Use • C-MAC® Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US • V4.3

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General information

1 General information 1.1 Reading the instructions for use It is recommended that the suitability of the products for the planned procedure be checked prior to use. These instructions for use are intended to serve as an aid in the proper handling, cleaning and, if need be, sterilization of the C-MAC® video laryngoscope and the monitor 8403 ZX. All of the necessary details and actions are clearly explained. We thus ask that you read these instructions carefully before proceeding to work with the instrument. Keep these instructions available for ready reference. If the instructions for use are not followed, patients, users, or third parties may be injured. In addition, the device may be damaged. 1. Read the instructions for use carefully and follow them completely. 2. Keep the instructions for use clearly visible next to the product. Note the instructions for use of the C-MAC® monitor (Art. No. 96076008D)!

1.2 Scope These instructions for use are valid for the following models: C-MAC® video laryngoscope 8403 AX/BX/HX/ AXC/BXC/DXC/EXC/GXC/KXC/MXC/HXP in connection with the video connecting cable 8403 X and monitor 8403 ZX or C-MAC® PM 8403 XD. .

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Product description

2 Product description 2.1 Product overview

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Product description

2

6

4 1

* 1

**

3

5

14

12

7

13

8

15

16

17

9 18

11

19

10

20

21

*

Models 8403 AXC/BXC/DXC/EXC/GXC/KXC/MXC/HXP

**

8403 AX/BX/HX with guidance for suction catheter

without guidance for suction catheter

1

C-MAC® Video Laryngoscope

2

Socket for video connecting cable (4)

3

Multifunction button (BlueButton)

4

Video connecting cable

5

Connection socket on monitor

6

Connection socket on laryngoscope

7

C-MAC® Pocket-Monitor

8

TFT display

9

Coupling element

10

C-MAC® Monitor

11

Second connection for videoscope

12

Primary connection for videoscope

13

Mains power connection

14

Reset button

15

Holder for SD memory card

16

Status bar

17

Power switch lamp

18

On/Off switch

19

Charge control lamp (orange)

20

Soft keys

21

Function symbols

22

HDMI port

23

USB port

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Product description

2.2 Packaging symbols Symbol

Meaning Consult the instructions for use

Keep away from sunlight

Keep dry

Temperature limit

In accordance with US federal law (21 CFR 801.109), this product may only be sold to or on prescription from a licensed physician. Humidity limitation

2.3 Symbols on the product Symbol

Meaning Follow the instructions for use

Type BF device

Serial number

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Intended use

3 Intended use 3.1 Intended purpose C-MAC® Video laryngoscopes: Video laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video laryngoscopes are designed for transient use in invasive procedures through a body orifice.

3.2 Contraindications No contraindications relating directly to the product are currently known. The use of the CMAC® video laryngoscope is contraindicated if, in the opinion of a responsible physician, the health of the patient is endangered through its use, for example, due to the patient's general condition, or if laryngoscopy as such is contraindicated.

3.3 Target user populations The C-MAC® video laryngoscope may only be used by persons with an appropriate medical qualification and who are acquainted with the laryngoscopy technique. The information in these instructions for use is intended only to instruct in the correct handling, cleaning and sterilization of the C-MAC® video laryngoscope, and is not suitable as an introduction to laryngoscopy technique. The use of the C-MAC® video laryngoscopes must be used in accordance with the airway algorithm in the respective country of application or the official specifications for airway management.

3.4 Training in the operation and function of the device Your local representative or responsible KARL STORZ member of staff is available to provide training and information on further training alternatives.

3.5 Target patient populations Gender

No restriction

Age

No restriction

Weight

No restriction

Medical condition

Suitable for the treatment, taking into account the indications and contraindications, according to the opinion of the physician

3.6 User qualifications Only physicians and medical support staff with a relevant specialist qualification and who have received training on the product may use the product. Only persons with appropriate specialist training may provide training. The user profile includes the following features: – Recognized medical qualification of the user (specialist physician, qualified medical staff) – Adequate powers of comprehension to rationally assess the current surgical situation – Adequate language skills in the languages used in the instructions for use – Be thoroughly trained in the operation and use of the medical device – Knowledge of the contents of the instructions for use

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Intended use

– No physical impairments that could diminish perception of activation and alarm signals (visual and acoustic)

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Safety

4 Safety 4.1 Serious incidents A "serious incident" includes, according to MDD incidents, those which, directly or indirectly, had, could have had or could have any of the following consequences (MDD, 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 should be notified of all serious incidents.

4.2 Description of warnings To prevent any injury to persons or damage to property, the warning messages and safety instructions in the instructions for use must be observed. The warnings 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 product could be damaged.

4.3 Notes on use Every user must be trained in the operation and use of the C-MAC® video laryngoscopes in combination with a C-MAC® Monitor 8403 ZX or C-MAC® PM 8403 XD, otherwise they may not be used. The use of the C-MAC® video laryngoscopes together with a C-MAC® Monitor 8403 ZX or CMAC® PM 8403 XD must be used in accordance with the airway algorithm in the respective country of application or the official specifications for airway management.

4.4 Unsterile instruments These products are not sterile when delivered. The use of unsterile products poses a risk of infection for patients, users, and third parties. Reprocess products before first use. Inspect products for visible contamination before use. Do not use contaminated products.

4.5 Correct reprocessing Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection.

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Safety

The instructions for use "Cleaning, Disinfection, Care, and Sterilization of KARL STORZ Instruments" (item no. 96216003) must be downloaded from http://www.karlstorz.com and followed. ð This is not applicable to U.S. market.

4.6 Risks from electric current If several products supplied with energy are used simultaneously, the patient leakage currents accumulate. These leakage currents can exceed the limit values and injure patients. Only use products of the same type, for example, endotherapy device and application part of type CF.

4.7 Risks due to damaged parts Check the following points before and after every use of the product: 1.

Completeness

2.

Good working order

3.

Correct assembly of the components

4.

Functionality Inspect products for visible contamination before use. Do not use contaminated products. Reprocess the products before use. Do not leave missing or broken-off components inside the patient.

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

4.9 Combination with other devices and accessories Combinations of medical devices are only assured to be safe if – they are identified as such in the respective instructions for use or – the intended use and interface specifications of the devices used in combination permit this. The use of unauthorized devices and accessories 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 (e.g. IEC 60950 for data processing equipment). 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). Anybody connecting additional equipment to medical electrical equipment is a system configurator and is therefore responsible for the system's compliance with the standard requirements for systems. Please note that local laws take priority over the above-mentioned standard requirements. Should you have any queries, please contact your local specialist dealer or the Technical Service (Standard/directive references: IEC 60601-1+A1+A2:1995: 6.8.2.c, 19.2.b, 19.2.c, IEC 60601-1:2005: 7.9.2.5, 8.1, 16.2.d, MDD 93/42/EEC: Annex I clause 13.6.c).

4.10 Damage to the instrument – The C-MAC® video laryngoscopes may not be cleaned in an ultrasound bath.

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Safety

– The C-MAC® video laryngoscopes may not be sterilized with steam.

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Installation and commissioning

5 Installation and commissioning 5.1 Visual and functional test Visual inspection

1 The medical device must be inspected for completeness, damage and integrity before and after every use. Tools such as a magnifying glass may be necessary to carry out the inspections. Missing components, surface changes or other damage to the medical device limit its life span and may mean that the device can no longer be used for its intended purpose. Check the instrument for: – Mechanical damage and changes, for example, sharp edges, burred edges, rough surfaces, protruding and bent parts (examples: Fig. 1 and 2)

2 – Signs of rust or corrosion – Damage to the coating, such as shown in Fig. 3

3 – Complete and intact seals (that are not cracked, porous or swollen) and joints – Residues and/or moisture present at the interfaces – All components present and correctly positioned – Mobility of all mobile components, if necessary once the components have been assembled in the case of instruments that can be dismantled – Complete, intact and securely positioned telescope and lens systems, e.g. with a magnifying glass (examples Fig. 4 and 5)

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Installation and commissioning

4

5 Test for proper operation Check the instrument for the following characteristics: – Fully functional control keys – Securely positioned connecting cable – Functional image transmission – Sufficient image quality – Light transmission

5.2 Initial operation The C-MAC® video laryngoscopes 8403 xxx can be operated with the following monitors: – C-MAC® monitor 8403 ZX (software version: 704v300 or higher) – C-MAC® PM Pocket-Monitor 8403 XD – with other monitors via the camera control unit C-HUB® II 20 2903 01 (software version: 721v105 or higher) WARNING Danger due to user error in the wrong viewing mode Wrong viewing mode Before each use or after a change of viewing modes/settings, the user should check to ensure the view observed through the endoscope provides a live image, rather than a stored one, and has the correct image orientation. The connecting cable can be removed during operation and connected to another laryngoscope. WARNING Danger due to non-insulated parts Risk of injury due to electrical current: It must be ensured that the electrically non-insulated parts of the videoscope do not come into contact with conductive surfaces, e.g., voltage-carrying elements of other units, at any time.

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Installation and commissioning

WARNING Optical radiation The optical radiation of the instrument can injure the eyes of patients, users, and third parties. Never look into the light output of a connected light transmission or endoscope. Wear suitable protective equipment. To prevent the telescope from fogging up, the C-MAC®, video laryngoscope should not be cooled below 18°C (64.4°F) and should be switched on in good time to allow the optical system to warm up. In extreme situations, the anti-fogging solution ‘ULTRA STOP’ with article number 15006 B can also be used.

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Application

6 Application 6.1 Connection to the C-MAC® monitor The video laryngoscopes 8403 xxx can only be connected to the C-MAC® monitor 8403 ZX. Older monitor types (8402/8401 ZX) are not compatible. 1. Connect the video connecting cable (6) to the socket (2) of the video laryngoscope. The orientation pin on the plug and socket facilitates connection. 2. Make sure that the cable is fully inserted. There must not be a visible gap.

2

6

Connect the video connecting cable coming from the video laryngoscope to the connection socket (12) (primary connection) or the connection socket (11) of the C-MAC® monitor.

11

12

The Monitor 8403 ZX enables two CMOS video units from KARL STORZ to be connected with Lemo connectors. Video units from other manufacturers cannot be connected.

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Application

If two cameras are connected, the user must select the camera for which the images are to be displayed in the menu (refer to the instruction manual for the C-MAC® monitor 8403 ZX Art. no. 96076008D). Switch on the monitor by pressing the power switch (18). The green power switch lamp (17) on the monitor and the blue multi-function button (3) of the video laryngoscope go on. ð The video laryngoscope is immediately ready to operate. As soon as the photo/video recording function is ready, the multi-function button (3) goes on.

17 18

3

6.2 Connection to the C-MAC® pocket monitor The 8403 xxx video laryngoscopes can only be connected to the C-MAC® PM 8403 XD. The 8401 XD model is not compatible. Note the instruction manual of the C-MAC® PM 8403 XD (Art. No. 96076020D). 1. Connect the C-MAC® PM with the socket (2) of the video laryngoscope blade. The orientation pin on the plug and socket facilitates connection. 2. Make sure that the plug is fully inserted. There must not be a visible gap. 3. The monitor can also be opened up when connecting both components. ð The video laryngoscope is immediately ready to operate. As soon as the photo/video recording function is ready, the multi-function button (3) goes on.

2

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Application

3

When inserting the C-MAC® PM into the video laryngoscope always ensure that the lugs of the plug connection are opposite each other.

6.2.1 Switching on the "Open-to-Intubate (OTI) displays" If the C-MAC® PM is closed when connected to the video laryngoscope blade, the following steps must be performed (Fig. A): 1. Fold the OTI display 8 upwards (Fig. B, C). 2. Turn the OTI display to the left (Fig. D). 3. Adjust the OTI display so that the image is optimally visible (Fig. E).

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Application

A

B

C

D

E

The image focus is adjusted automatically. Manual adjustment is not necessary. The C-MAC® video laryngoscope with C-MAC® PM is ready for operation.

6.2.2 Switching off the "Open to intubate" (OTI)-Displays 1. Turn the OTI display (8) to the right (Fig. D). 2. Fold the OTI display to the right (Fig. C). 3. Fold the OTI display downwards (Fig. B). 4. The C-MAC® PM is switched off.

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