KARL STORZ C-MAC PM 8401 XD Instruction For Use V3.1 Nov 2019

11/2019 © 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 Intended use ... 6 2.1 Intended use ... 6 2.2 Contraindications... 6 2.3 Target user populations ... 6 2.4 User qualifications ... 6 2.5 Safety precautions when using the C-MAC® video laryngoscope ... 6 2.6 Safety precautions when using the C-MAC® PM ... 7 2.7 Training in the operation and function of the device ... 7 2.8 Target patient populations ... 7 3 Safety ... 8 3.1 Serious incidents ... 8 3.2 Description of warnings ... 8 3.3 Unsterile instruments ... 8 3.4 Correct reprocessing ... 8 3.5 Risks due to damaged parts... 8 3.6 Combination with other devices and accessories ... 9 3.7 Damage to the instrument ... 9 3.8 Damaged products ... 9 3.9 Allergic reactions ... 9 4 Product description ... 10 4.1 Product overview ... 10 4.2 Packaging symbols... 12 4.3 Symbols on the product ... 12 4.4 Charging Unit for C-MAC® PM ... 12 5 Installation and commissioning... 14 5.1 Visual and functional test... 14 5.2 Initial operation ... 15 5.2.1 Operating the C-MAC® PM... 15 5.2.2 Energy management... 17 5.2.3 Putting the electronic module into service ... 18 5.2.4 Focus ... 18 6 Application ... 19 6.1 Function keys for the video laryngoscope ... 19 6.2 Monitor function keys ... 19 6.3 Insertion of an oxygen or suction catheter (only with 8401 AX/BX/HX)... 19 6.4 Disassembly... 20 6.5 C-MAC® bag 8403 YD ... 20 7 Reprocessing ... 21 7.1 Cleaning and disinfection ... 21 7.2 Manual cleaning and disinfection ... 22 7.3 Machine cleaning and disinfection ... 22 7.4 Overview table ... 23 7.5 Sterilization ... 23 8 Service and repair ... 25 8.1 Servicing and repair program ... 25 8.2 Complaint shipments ... 25 9 Limitation of Liability ... 26

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Table of contents

10 Guarantee ... 27 11 Standards, directives and regulations ... 28 11.1 Standards, directives and regulations ... 28 11.2 Standard compliance... 28 12 Disposal ... 29 13 Technical data... 30 14 Fault correction ... 32 14.1 Troubleshooting ... 32 15 Accessories and spare parts ... 34 15.1 Accessories... 34 16 Electromagnetic compatibility... 35 17 Subsidiaries... 36

Instruction For Use • C-MAC® video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC® PM 8401 XD • 96076011EN-US • V3.1

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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® Videolaryngoskop 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 8401 AX/BX/HX/AXC/BXC/DXC/GXC/KXC/HXP in connection with Electronic Module 8401 X/8402 X and Monitor 8401 ZX/8402 ZX/8403 ZX or C-MAC PM 8401 XD. .

Instruction For Use • C-MAC® video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC® PM 8401 XD • 96076011EN-US • V3.1

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Intended use

2 Intended use 2.1 Intended use The C-MAC® video laryngoscope 8401 AX/BX/HX/AXC/BXC/DXC/GXC/KXC/HXP is used in conjunction with the Electronic Module 8401 X/8402 X and the monitor 8401 ZX/8402 ZX/8403 ZX or the C-MAC® PM for endotracheal intubation and the inspection of the oropharynx. The Monitor 8403 ZX has separate instructions for use (96076008D).

2.2 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 by its use, for example, due to the patient's general condition, or if laryngoscopy as such is contraindicated.

2.3 Target user populations The C-MAC® Videolaryngoskop 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® Videolaryngoskop, 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.

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

2.5 Safety precautions when using the C-MAC® video laryngoscope The C-MAC® video laryngoscope must be used according to the medical rules and procedures recognized for laryngoscopy. The C-MAC® video laryngoscope has been successfully tested on helicopters BK 117 B2, EC 135 and EC 145 for electromagnetic compatibility according to DRF EMI Test REPORT (Rev. C). The C-MAC® video laryngoscope as well as the C-MAC® Monitor 8402 ZX have been successfully tested on the RTCA/DO-160F (Section 21). The C-MAC® video laryngoscope as well as the C-MAC® Monitor 8402 ZX have been successfully subjected to a fall and crash test.

Instruction For Use • C-MAC® video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC® PM 8401 XD • 96076011EN-US • V3.1

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Intended use

The C-MAC® video laryngoscope as well as the C-MAC® Monitor 8402 ZX have been successfully tested on the MIL-STD-461F, RE102 (Fixed Wing). The C-MAC® video laryngoscope as well as the C-MAC® Monitor 8402 ZX have been successfully tested by the German Army's Technical and Airworthiness Centre for Aircraft (Wehrtechnische Dienststelle für Luftfahrzeuge (WTD 61)) on the aircraft types Sea Lynx Mk. 88A and Sea King Mk. 41 for SAR (Search and Rescue) missions.

2.6 Safety precautions when using the C-MAC® PM The C-MAC® PM with C-MAC video laryngoscope blade must be used according to the medical rules and procedures recognized for laryngoscopic methods. The C-MAC® PM has been successfully tested on the RTCA/DO-160F (Section 21). Note: The C-MAC® PM has been successfully tested on the MIL-STD-461F, RE102 (Fixed Wing).

2.7 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.

2.8 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

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Safety

3 Safety 3.1 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.

3.2 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.

3.3 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.

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

3.5 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

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Safety

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.

3.6 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).

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

3.8 Damaged products WARNING Risk of injury from damaged products Before each use the outer surfaces of the parts of the laryngoscope and all the laryngoscopic accessories which are to be inserted into the patient must be checked in order to ensure that there are no unintentional rough surfaces, sharp corners or projecting parts which could present a hazard to the patient.

3.9 Allergic reactions C-MAC® laryngoscope blades contain a nickel compound and may cause nickel allergy in predisposed individuals.

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Product description

4 Product description 4.1 Product overview

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Product description

10

3 11

6

4

12

5

9

6

2

1 *

1 ** 7 8

* Models 8401 AXC/BXC/DXC/GXC/KXC/HXP

** 8401 AX/BX/HX with guidance for suction

without guidance for suction catheter

catheter

1

Laryngoscope blade with holder for electronic module

2

Electronic module

3

Connecting cable for video monitor

4

Function key for video recording

5

Function key for single image capture

6

Video connection socket on laryngoscope blade

7

LED illumination

8

Image sensor

9

Connection for electronic module

10

C-MAC®Pocket Monitor)

11

TFT monitor)

12

Battery status display

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Product description

4.2 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

4.3 Symbols on the product Symbol

Meaning Follow the instructions for use

Type BF device

Serial number

4.4 Charging Unit for C-MAC® PM WARNING Danger of electric shock Do not touch the patient and the charger plug at the same time. For this reason, the battery should be recharged outside the patient environment. Use only the charging station Art. No. 8401 XDL for recharging. The procedure is described in the instructions for use of the charging station (Art. No. 96076005D) After only 1 hour, approx. 80% of the charging process is complete. It takes around 3 hours to charge the battery fully. 1. Insert the C-MAC® PM into the charging compartment. ð The charge status display (14) of the C-MAC® PM lights up orange. 2. When the status display lights up green, remove the C-MAC® PM from the charging compartment.

Instruction For Use • C-MAC® video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC® PM 8401 XD • 96076011EN-US • V3.1

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Product description

3. Test for proper operation.

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Installation and commissioning

5 Installation and commissioning 5.1 Visual and functional test Visual inspection 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 (example: Fig. 1)

1 – Signs of rust or corrosion – Damage to the coating – Complete and intact seals (that are not cracked, porous or swollen) and joints – Complete, intact and securely positioned telescope and lens systems, e.g. with a magnifying glass (example: Fig. 2). In the example below (Fig. 3), the covering glass and the lens are missing.

2

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Installation and commissioning

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

5.2 Initial operation 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. WARNING Increased temperatures The high-intensity light emitted by the laryngoscope can result in increased temperatures at the light outlet of the LED.

5.2.1 Operating the C-MAC® PM Push the C-MAC® PM (12) into the receptacle of the C-MAC® video laryngoscope (1) (Fig. A) Switching on the Open-to-Intubate (OTI) display 1. Fold the OTI display (13) upwards (Fig. A, B). 2. Flip the OTI display to the left (Fig. C). 3. Adjust the OTI display so that the image is optimally visible (Fig. D). The image focus is adjusted automatically. Manual adjustment is not necessary.

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Installation and commissioning

Depending on the composition of the image, there may be slight image deterioration in the first 5-8 seconds. The C-MAC® video laryngoscope with C-MAC® PM is ready for operation. WARNING Switching off the display After 10 minutes, the display of the C-MAC® PM turns off automatically and must be turned back on again by closing it and reopening it.

Switching off the Open to intubate (OTI) display 1. Put the OTI display (13) into the horizontal position (Fig. C). 2. Flip the OTI display to the right (Fig. B). 3. Fold the OTI display downwards (Fig. A). ð The C-MAC® PM is switched off. The C-MAC® PM can be removed from the C-MAC® video laryngoscope during operation and inserted into another C-MAC® video laryngoscope. It is not necessary to perform a white balance.

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Installation and commissioning

B

A

C

D

5.2.2 Energy management The battery charge status is shown on the display for the first 10 seconds of operation.

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Installation and commissioning

The lithium ion battery can be used for approx. 1 hour when fully charged. WARNING Low battery If the charge status symbol flashes red, the charge of the C-MAC® PM is too low. In this state, it will only function for another 10 minutes. Connect the C-MAC® PM to the corresponding charge station (8401 XDL) when the charge status symbol flashes red at the latest. For the C-MAC® PM there is a specially designed bag 8402 YE available, which can be ordered as an option (see chapter 15.1, Accessories [ 34]). The C-MAC® PM is also included in a set which includes several different C-MAC® video laryngoscopes. The article number is 8400 B "Intubation Set -C22-, Model ULM".

5.2.3 Putting the electronic module into service Push the electronic module (2) into the receptacle of the video laryngoscope. The electronic module can be removed from the laryngoscope and inserted into another laryngoscope during operation.

2

5.2.4 Focus When using C-MAC® video laryngoscope blades, the image is focused automatically. Manual focusing is not possible/necessary.

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Application

6 Application 6.1 Function keys for the video laryngoscope Video recording: When the function key "Video recording" (4) is pressed, the C-MAC® video laryngoscope saves a video stream on the SD memory card incorporated in the connected Monitor 8403 ZX. Pressing the key a second time stops the recording.

The video stream can only be viewed on a PC if an MPEG 4-codec is installed on the PC. Single image capture: When the function key "Single image capture" (5) is pressed, the current image on the monitor is saved on the SD memory card incorporated in the connected Monitor 8403 ZX.

6.2 Monitor function keys The monitor is equipped with 4 softkeys that can be used to activate several other functions. A more detailed description of the functions can be found in the instructions for use for the monitor "C-MAC® Monitor 8403 ZX" (Art. No. 96076008D).

6.3 Insertion of an oxygen or suction catheter (only with 8401 AX/BX/HX) If a blade with oxygen or suction catheter guide is used, the probe/catheter is advanced over the guide until visibility in the image is guaranteed. When using the blade 8401 AX, the catheters 14 Fr. and 16 Fr. can be used. When using the blades 8401 HX and 8401 BX, catheters 16 Fr. and 18 Fr. can be used.

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Application

6.4 Disassembly 1. Unplug the connecting cable from the C-MAC® monitor connection. 2. Push the connecting cable or the C-MAC® electronic module (2) (Fig. A) from the video laryngoscope or the C-MAC® PM (12) (Fig. B) out of the video laryngoscope.

A

B

6.5 C-MAC® bag 8403 YD The optionally available protective bag 8403 YD facilitates the mobile use of the C-MAC® system.

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