Instruction For UseC-MAC® video laryngoscope 8401xxx, ElectronicModule 8401/8402 X, C-MAC® PM 8401 XD

en

© KARL STORZ

It is not permitted to forward or reproduce this document or to use or disclose the contents thereof unlessexpress consent is given.

Publisher

KARL STORZ SE & Co. KGDr.-Karl-Storz-Straße 34 78532 Tuttlingen

Postfach 230 78503 Tuttlingen

Germany

Tel.: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com

11/2019

Table of contents

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

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Table of contents1 General information....................................................................................................................................... 51.1 Reading the instructions for use ...............................................................................................................  51.2 Scope........................................................................................................................................................  52 Intended use ................................................................................................................................................. 62.1 Intended use .............................................................................................................................................  62.2 Contraindications......................................................................................................................................  62.3 Target user populations ............................................................................................................................  62.4 User qualifications ....................................................................................................................................  62.5 Safety precautions when using the C-MAC® video laryngoscope ...........................................................  62.6 Safety precautions when using the C-MAC® PM .....................................................................................  72.7 Training in the operation and function of the device ................................................................................  72.8 Target patient populations........................................................................................................................  73 Safety ............................................................................................................................................................ 83.1 Serious incidents ......................................................................................................................................  83.2 Description of warnings ............................................................................................................................  83.3 Unsterile instruments ................................................................................................................................  83.4 Correct reprocessing ................................................................................................................................  83.5 Risks due to damaged parts.....................................................................................................................  83.6 Combination with other devices and accessories ....................................................................................  93.7 Damage to the instrument ........................................................................................................................  93.8 Damaged products ...................................................................................................................................  93.9 Allergic reactions ......................................................................................................................................  94 Product description .................................................................................................................................... 104.1 Product overview ....................................................................................................................................  104.2 Packaging symbols.................................................................................................................................  124.3 Symbols on the product .........................................................................................................................  124.4 Charging Unit for C-MAC® PM ...............................................................................................................  125 Installation and commissioning................................................................................................................... 145.1 Visual and functional test........................................................................................................................  145.2 Initial operation .......................................................................................................................................  15

5.2.1 Operating the C-MAC® PM..........................................................................................................  155.2.2 Energy management....................................................................................................................  175.2.3 Putting the electronic module into service ..................................................................................  185.2.4 Focus ...........................................................................................................................................  18

6 Application .................................................................................................................................................. 196.1 Function keys for the video laryngoscope..............................................................................................  196.2 Monitor function keys .............................................................................................................................  196.3 Insertion of an oxygen or suction catheter (only with 8401 AX/BX/HX)..................................................  196.4 Disassembly............................................................................................................................................  206.5 C-MAC® bag 8403 YD ............................................................................................................................  207 Reprocessing .............................................................................................................................................. 217.1 Cleaning and disinfection .......................................................................................................................  217.2 Manual cleaning and disinfection ...........................................................................................................  227.3 Machine cleaning and disinfection .........................................................................................................  227.4 Overview table ........................................................................................................................................  237.5 Sterilization .............................................................................................................................................  238 Service and repair ....................................................................................................................................... 258.1 Servicing and repair program .................................................................................................................  258.2 Complaint shipments ..............................................................................................................................  259 Limitation of Liability ................................................................................................................................... 26

Table of contents

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10 Guarantee ................................................................................................................................................... 2711 Standards, directives and regulations ........................................................................................................ 2811.1 Standards, directives and regulations ....................................................................................................  2811.2 Standard compliance..............................................................................................................................  2812 Disposal ...................................................................................................................................................... 2913 Technical data............................................................................................................................................. 3014 Fault correction ........................................................................................................................................... 3214.1 Troubleshooting ......................................................................................................................................  3215 Accessories and spare parts ...................................................................................................................... 3415.1 Accessories.............................................................................................................................................  3416 Electromagnetic compatibility..................................................................................................................... 3517 Subsidiaries................................................................................................................................................. 36

General information

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1 General information

1.1 Reading the instructions for useIt is recommended that the suitability of the products for the planned procedure be checkedprior 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 thenecessary details and actions are clearly explained. We thus ask that you read theseinstructions carefully before proceeding to work with the instrument. Keep these instructionsavailable for ready reference.

If the instructions for use are not followed, patients, users, or third parties may be injured. Inaddition, 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 ScopeThese instructions for use are valid for the following models: C-MAC® video laryngoscope 8401AX/BX/HX/AXC/BXC/DXC/GXC/KXC/HXP in connection with Electronic Module 8401 X/8402 Xand Monitor 8401 ZX/8402 ZX/8403 ZX or C-MAC PM 8401 XD.

.

Intended use

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2 Intended use

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

2.2 ContraindicationsNo contraindications relating directly to the product are currently known. The use of the C-MAC® video laryngoscope is contraindicated if, in the opinion of a responsible physician, thehealth of the patient is endangered by its use, for example, due to the patient's generalcondition, or if laryngoscopy as such is contraindicated.

2.3 Target user populationsThe C-MAC® Videolaryngoskop may only be used by persons with an appropriate medicalqualification and who are acquainted with the laryngoscopy technique. The information inthese instructions for use is intended only to instruct in the correct handling, cleaning andsterilization of the C-MAC® Videolaryngoskop, and is not suitable as an introduction tolaryngoscopy technique. The use of the C-MAC® video laryngoscopes must be used inaccordance with the airway algorithm in the respective country of application or the officialspecifications for airway management.

2.4 User qualificationsOnly physicians and medical support staff with a relevant specialist qualification and who havereceived training on the product may use the product. Only persons with appropriate specialisttraining 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® videolaryngoscopeThe C-MAC® video laryngoscope must be used according to the medical rules and proceduresrecognized 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 beensuccessfully tested on the RTCA/DO-160F (Section 21).

The C-MAC® video laryngoscope as well as the C-MAC® Monitor 8402 ZX have beensuccessfully subjected to a fall and crash test.

Intended use

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The C-MAC® video laryngoscope as well as the C-MAC® Monitor 8402 ZX have beensuccessfully tested on the MIL-STD-461F, RE102 (Fixed Wing).

The C-MAC® video laryngoscope as well as the C-MAC® Monitor 8402 ZX have beensuccessfully tested by the German Army's Technical and Airworthiness Centre for Aircraft(Wehrtechnische Dienststelle für Luftfahrzeuge (WTD 61)) on the aircraft types Sea LynxMk. 88A and Sea King Mk. 41 for SAR (Search and Rescue) missions.

2.6 Safety precautions when using the C-MAC® PMThe C-MAC® PM with C-MAC video laryngoscope blade must be used according to themedical 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 (FixedWing).

2.7 Training in the operation and function of the deviceYour local representative or responsible KARL STORZ member of staff is available to providetraining and information on further training alternatives.

2.8 Target patient populationsGender No restriction

Age No restriction

Weight No restriction

Medical condition Suitable for the treatment, taking into accountthe indications and contraindications, accord-ing to the opinion of the physician

Safety

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3 Safety

3.1 Serious incidentsA "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 warningsTo prevent any injury to persons or damage to property, the warning messages and safetyinstructions in the instructions for use must be observed. The warnings describe the followinglevels of danger.

WARNINGWARNING

Designates a possible imminent risk. If this is not avoided, it could lead to death or seriousinjuries.

CAUTIONCAUTION

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 instrumentsThese products are not sterile when delivered. The use of unsterile products poses a risk ofinfection 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 reprocessingIncorrectly reprocessed products expose patients, users, and third parties to a risk of infection.

The instructions for use "Cleaning, Disinfection, Care, and Sterilization of KARL STORZInstruments" (item no. 96216003) must be downloaded from http://www.karlstorz.com andfollowed.

3.5 Risks due to damaged partsCheck the following points before and after every use of the product:

1. Completeness

2. Good working order

3. Correct assembly of the components

Safety

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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 accessoriesCombinations 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 permitthis.

The use of unauthorized devices and accessories or unauthorized changes to the product canresult in injuries.

Additional devices connected to electrical medical equipment must comply with the relevantIEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, allconfigurations must comply with the requirements for medical electrical systems (see IEC60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1).

Anybody connecting additional equipment to medical electrical equipment is a systemconfigurator and is therefore responsible for the system's compliance with the standardrequirements for systems. Please note that local laws take priority over the above-mentionedstandard requirements. Should you have any queries, please contact your local specialistdealer 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 clause13.6.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 laryngoscopicaccessories which are to be inserted into the patient must be checked in order to ensure thatthere are no unintentional rough surfaces, sharp corners or projecting parts which couldpresent a hazard to the patient.

3.9 Allergic reactionsC-MAC® laryngoscope blades contain a nickel compound and may cause nickel allergy inpredisposed individuals.

Product description

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4 Product description

4.1 Product overview

Product description

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1

7

8

96

1

4

2

3

5

6

***

* Models 8401 AXC/BXC/DXC/GXC/KXC/HXPwithout guidance for suction catheter

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

11

10

12

1 Laryngoscope blade with holder for elec-tronic 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 laryngoscopeblade

7 LED illumination 8 Image sensor

9 Connection for electronic module 10 C-MAC®Pocket Monitor)

11 TFT monitor) 12 Battery status display

Product description

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4.2 Packaging symbolsSymbol 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 mayonly be sold to or on prescription from a licensed physician.

Humidity limitation

4.3 Symbols on the productSymbol 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 batteryshould be recharged outside the patient environment.

Use only the charging station Art. No. 8401 XDL for recharging. The procedure isdescribed 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 3hours 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 chargingcompartment.

Product description

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3. Test for proper operation.

Installation and commissioning

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5 Installation and commissioning

5.1 Visual and functional test

Visual inspection

The medical device must be inspected for completeness, damage and integrity before andafter every use. Tools such as a magnifying glass may be necessary to carry out theinspections.

Missing components, surface changes or other damage to the medical device limit its life spanand 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, roughsurfaces, 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 amagnifying glass (example: Fig. 2). In the example below (Fig. 3), the covering glass andthe lens are missing.

2

Installation and commissioning

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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 beenassembled 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.

WARNINGIncreased temperatures

The high-intensity light emitted by the laryngoscope can result in increased temperatures atthe light outlet of the LED.

5.2.1 Operating the C-MAC® PMPush 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.

Installation and commissioning

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Depending on the composition of the image, there may be slight image deterioration in thefirst 5-8 seconds.

The C-MAC® video laryngoscope with C-MAC® PM is ready for operation.

WARNINGSwitching off the display

After 10 minutes, the display of the C-MAC® PM turns off automatically and must be turnedback 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 operationand inserted into another C-MAC® video laryngoscope.

It is not necessary to perform a white balance.

Installation and commissioning

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AB

C D

5.2.2 Energy management

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

Installation and commissioning

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The lithium ion battery can be used for approx. 1 hour when fully charged.

WARNINGLow 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 chargestatus symbol flashes red at the latest.For the C-MAC® PM there is a specially designed bag 8402 YE available, which can beordered as an option (see chapter 15.1, Accessories [ 34]). The C-MAC® PM is alsoincluded in a set which includes several different C-MAC® video laryngoscopes. The articlenumber is 8400 B "Intubation Set -C22-, Model ULM".

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

2

5.2.4 FocusWhen using C-MAC® video laryngoscope blades, the image is focused automatically. Manualfocusing is not possible/necessary.

Application

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6 Application

6.1 Function keys for the video laryngoscopeVideo recording: When the function key "Video recording" (4) is pressed, the C-MAC® videolaryngoscope saves a video stream on the SD memory card incorporated in the connectedMonitor 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 currentimage on the monitor is saved on the SD memory card incorporated in the connected Monitor8403 ZX.

6.2 Monitor function keysThe 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 themonitor "C-MAC® Monitor 8403 ZX" (Art. No. 96076008D).

6.3 Insertion of an oxygen or suction catheter (only with8401 AX/BX/HX)If a blade with oxygen or suction catheter guide is used, the probe/catheter is advanced overthe 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 theblades 8401 HX and 8401 BX, catheters 16 Fr. and 18 Fr. can be used.

Application

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6.4 Disassembly1. 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 videolaryngoscope or the C-MAC® PM (12) (Fig. B) out of the video laryngoscope.

A

B

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

system.

Reprocessing

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7 Reprocessing

7.1 Cleaning and disinfection CAUTION

Damage to the product!

Only perform reprocessing using chemicals approved by KARL STORZ. A list of approvedchemicals can be requested from hygiene@karlstorz.com.

The instructions for use "Cleaning, Disinfection, Care, and Sterilization of KARL STORZInstruments" (item no. 96216003) must be downloaded from http://www.karlstorz.com andfollowed.NOTE: The connector and the corresponding sockets in the laryngoscope and in theelectronic module are absolutely water-tight in all eventualities. All three connections arealso resistant to the process chemicals used in the validated reprocessing methodsemployed. You may leave the connections unprotected during the validated reprocessingprocedures. In particular when the tray holder 39501 LC2 is used in a reprocessingmachine, no further accessories are needed.

CAUTIONDamage to the product

To prevent possible damage, these connections may only be fitted together when dry. Ifreprocessing is carried out which does not provide for drying or where compressed air dryingcannot be carried out, the reprocessing cap 8401 YZ must therefore be used.

The C-MAC® laryngoscope as well as the Electronic Modules 8401 X/8402 X are suitable andvalidated for the following low-temperature reprocessing methods up to max. 65 °C: manual/machine cleaning and disinfection, sterilization with Steris® AMSCO V-PRO 1, Sterrad® (100/NX) and EtO gas.

The monitor 8402 ZX/8403 ZX can be wipe-down disinfected.

The C-MAC® PM 8401 XD is suitable and validated for the following low-temperaturereprocessing methods up to max. 65 °C: manual/machine cleaning and disinfection.

Reprocessing using STERRAD® can cause cosmetic changes to the surface of the blade,although these have no effect on its function.

Reprocessing

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CAUTIONDamage due to corrosion

The laryngoscope and electronic module are equipped with gold contacts that preventcorrosion. However, particularly in the case of manual reprocessing, the contacts must bethoroughly rinsed using microbiologically pure/sterile water when rinsed for the last time.Afterwards, the contacts and the instrument must be carefully dried, preferably with sterilecompressed air.

7.2 Manual cleaning and disinfectionStart reprocessing the used instrument as soon as possible, since encrusted debris can causeirreparable damage. Remove major debris using an active cleaner, e.g. tenside-based, and adisinfected sponge or soft, disinfected brush.

Place in a disinfection solution; avoid air bubbles and ensure complete wetting. Follow thechemical manufacturer's instructions on concentration and exposure time.

Rinse thoroughly with microbiologically pure/sterile water, then dry.Electrical contacts must be dried very carefully.

7.3 Machine cleaning and disinfectionThe choice of cleaning programs must be agreed with the washing machine manufacturer.

CAUTIONDamage to the product

Clean and chemically disinfect the C-MAC® video laryngoscope in the washer-disinfector at amaximum temperature of 65 °C. The temperature of the drying program must not exceed65 °C.

Reprocessing

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Clean the optical surfaces of the image chip (8) and LED illuminator (7) on the C-MAC® videolaryngoscope with a cotton tip applicator soaked in 70% isopropyl alcohol.

Electrical contacts must be dried very carefully.

7.4 Overview tableCleaning, disinfection and sterilization

Ultr

asou

nd

Man

ual

clea

ning

and

disi

n-fe

ctio

n

Mac

hine

clea

ning

(65 

°C)

Mac

hine

clea

ning

(93 

°C)

Ste

am s

ter-

iliza

tion

Gas

ste

ril-

izat

ion

Hyd

roge

npe

roxi

dest

erili

zatio

n

Ste

ris S

ys-

tem

1®

C-MAC®

videolaryngo-scopes

X ● ●* X X ● ● ●

C-MAC®

PM 8401XD

X ● ●* X X X X X

ElectronicModule8401X/8402 X

X ● ●* X X ● ● X

● Suitable methods

X Unsuitable procedures

* Device-specific

7.5 Sterilization CAUTION

Danger due to steam sterilization

Do not steam sterilize the C-MAC® video laryngoscope, the Electronic Module 8401 X/8402 Xand the C-MAC® PM 8401 XD.

For sterilization with gas or with Steris System1®, country-specific laws and regulationsmust be observed.

CAUTIONDamage to the product

For sterilization in the Steris System 1® and Steris System 1E, the reprocessing cap 8401 YZmust be put on first.

Reprocessing

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Chemically sterilize the C-MAC® video laryngoscope in dismantled condition.

Service and repair

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8 Service and repair

8.1 Servicing and repair programDefective instruments must be serviced and repaired exclusively by persons authorized by us;all repair work must employ original parts.

To bridge the repair period, you will generally receive a device on loan, which must then bereturned to KARL STORZ as soon as you receive the repaired device. In Germany you canrefer repairs directly to:

KARL STORZ SE & Co. KG

Abt. Reparaturservice

Take-off Gewerbepark 83

78579 Neuhausen, Germany

Service hotline: +49 7461/708 980

E-mail: technicalsupport@karlstorz.com

In other countries, please contact your local KARL STORZ subsidiary or authorized dealer.

8.2 Complaint shipmentsIn the interests of our employees' health, only sterilized or disinfected products are acceptedas return shipments. These should be marked as such; otherwise no further processing may beperformed.

Limitation of Liability

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9 Limitation of LiabilityAs a supplier of this instrument, we consider ourselves responsible for the safety, reliability andperformance of the instrument only if: Assembly, extension, new adjustments, changes orrepairs are carried out by persons authorized by KARL STORZ and the instrument is used inaccordance with the instructions for use.

Guarantee

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10 GuaranteeFor information concerning the guarantees provided, please see the Standard Conditions ofBusiness of KARL STORZ. The medical device must always be sent to your local subsidiary(see the section ‘Subsidiaries’), even during the warranty period. Opening of the equipment orperformance of any repairs or modifications to the equipment by unauthorized persons shallrelieve us of any liability for its performance. Any such opening, repair, or modificationperformed during the warranty period shall void all warranty.

Standards, directives and regulations

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11 Standards, directives and regulations

11.1 Standards, directives and regulationsAccording to Medical Device Directive (MDD):

Class I medical devices. These medical devices bear the CE mark in accordance with theMedical Device Directive (MDD) 93/42/EEC.

11.2 Standard compliance(for 8401 AX, BX, HX, AXC, BXC, DXC, GXC, KXC, HXP, X, XD, ZX, for 8402 X/ZX, 8403 ZX)

Complies with EN 60601-1, EN 60601-2-18, UL 2601, CSA 601.1:

– Provides Type BF protection when used in conjunction with a KARL STORZ cameracontrol unit with a BF symbol on the connection port.

– Type of protection against electric shocks: Protection Class II (does not apply to 8401 XD)

According to IEC 60601-1-2:

Please read the electromagnetic compatibility information in chapter 16 [ 35].

Additional standards:

(for 8401 AX, BX, HX, AXC, BXC, DXC, GXC, KXC, HXP, X, ZX, for 8402 X/ZX)

DO-160F, EMI Test Report (DRF Luftrettung)

(for 8401 AX, BX, HX, AXC, BXC, DXC, GXC, KXC, HXP, X, XD, ZX for 8402 X/ZX)

for 8402 X/ZX)

MIL-STD-461F (Fixed Wing)

(for 8401 XD)

DO-160F

Disposal

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12 DisposalThis device has been marked in accordance with the European Directive on waste electricaland electronic equipment (WEEE). At the end of its useful operating life, dispose of the unit aselectronic scrap. Please ask KARL STORZ SE & Co. KG, a KARL STORZ subsidiary or yourauthorized dealer about the collection point in your area. Within the scope of application of thisdirective, KARL STORZ SE & Co. KG is responsible for the proper disposal of this device.National regulations/laws must be observed.

Technical data

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13 Technical dataElectronic module 8401 X/8402 X

Classification: IEC Class II

Line frequency: DC

Voltage: 5 V

Power consumption: 2 VA

Immersion protection: IPX8

Blade 8401 AX/BX/HX/AXC/BXC/DXC/GXC/KXC/HXP

Immersion protection: IPX8

Camera technology CMOS

Resolution: 320 x 240

Illumination: LED, white, 1 W

Average life cycle

Reprocessing cycles: 200*

* Value indicates the number of tested cycles. The device’s life span may be compromised ifthe recommended number of cycles is exceeded.

Inspect the device for damage before and after every use (see the chapter "Symbols anddanger notes" and the chapter "Visual and functional test").

Color settings

Back Page Settings

8403 ZX:

Brightness: 40%

Contrast: 35%

Saturation: 40%

Hue: 50%

8402 ZX:

Brightness: 30%

Contrast: 25%

Saturation: 40%

Hue: 100%

8401 ZX:

Brightness: 56%

Contrast: 50%

Saturation: 20%

Hue: 0%

Technical data

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Charging station 8401 XDL

Classification: IEC Class II

Line frequency: DC

Voltage: 5 V

Power consumption: 2 VA

Weight: Approx. 230 g

C-MAC® PM 8401 XD

Line frequency: DC

Voltage: 3.7 V

Power consumption: 1.5 W

Immersion protection: IPX8

Fault correction

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14 Fault correction

14.1 Troubleshooting

WARNING

Always unplug the device before doing any cleaning and maintenance work onthe device.

Symptom Possible causes Remedy

Complete failure of the de-vice. Possible lighting up ofstatus display.

– No power from the powerline.

– Power cord connector isnot properly connected todevice socket.

– System error

– Check the power supply.

– Push the power supplyplug firmly into the socketon the device.

– Reset.

No picture, TFT screen dark. – Electronic module/C-MAC® PM not fullyinserted.

– Defective cameraelectronics.

– TFT screen defective.

– Slide electronic module/C-MAC® PM in as far as itwill go.

– Send electronic module/C-MAC® PM or supplyunit to KARL STORZ forrepair.

Cloudy picture, stripes,streaks, or similar.

– Telescope of thelaryngoscope is soiled.

– Contacts of the electronicmodule/C-MAC® PM aresoiled.

– Clean with cotton swaband alcohol solution orspecial cleaning paste.

– Clean the contacts of theelectronic module/C-MAC® PM.

Color distortions. – White balance not carriedout correctly.

– Electronic module defect.

– Carry out new whitebalance.

– Send the supply unit forrepairs to KARL STORZ.

Color rendering alternates. – Camera connecting cableis defect.

– Have a new cameraconnecting cable fitted.

Image cannot be saved. – No memory cardinserted.

– Memory card full.

– Memory card is notrecognized.

– Insert memory card.

– Change memory card.

– Insert the memory cardwhile the C-MAC®

Monitor is switched offand then turn the monitoron again.

– Perform a reset.

– Format the memory cardon the PC with FAT(standard).

Fault correction

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Video stream cannot beplayed back on the PC moni-tor.

– No MPEG-4 Codecinstalled.

– Install an MPEG-4 Codecon the PC.

SD memory card cannot bewritten on.

– SD memory card isformatted incorrectly.

– Format the SD memorycard on the PC with FAT(standard).

Accessories and spare parts

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15 Accessories and spare parts

15.1 Accessories809125 MAGILL forceps, modified by  BOEDEKER,length 25 cm, suitable for the endoscopic removalof foreign bodies, for use with video laryngoscopesof sizes 2 – 4

809120 MAGILL forceps, for children, modified by BOEDEKER, length 20 cm, suitable for the endo-scopic removal of foreign bodies, for use withvideo laryngoscopes of sizes 1 – 2

8402YE Bag for intubation set -C22-, model ULM,made of water-repellent and hard-wearing surfacematerial, washable, the bag contains two compart-ments with several holding possibilities for C-MAC® video laryngoscopes with C-MAC® PocketMonitor and for conventional laryngoscopes, foruse with C-MAC® Pocket Monitor 8401 XDX, C-MAC® video laryngoscopes and conventionallaryngoscopes

8401 YZ multifunctional cap for use in the SterisSystem1® to protect the contacts during repro-cessing. Suitable for the C-MAC® video laryngo-scope, the C-MAC® electronic module and the C-MAC® PM. The cap is reusable.

39501 LC2 wire tray for cleaning, sterilization andstorage for two C-MAC® video laryngoscopeblades incl. an electronic module, with holder forfixing and sealing the electronic connections. Ex-ternal dimensions (W x D x H): 260 x 120 x 170 mm

Electromagnetic compatibility

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16 Electromagnetic compatibilityThe applied part described in these instructions for use has been tested as a system with thefollowing basic devices. For relevant electromagnetic compatibility (EMC) information, refer to‘Electromagnetic Compatibility (EMC) information’ in the instructions for use for these basicdevices:

Basic device Instructions for use

C-MAC® Monitor 8403 ZX 96076008 D

C-MAC® Pocket Monitor 8403 XD 96076020 D

C-HUB® II 20 2903 20 96206529 D

The EMC warning statements, precautions, notes and Emission/Immunity limits specified in theinstructions for use for the basic devices also apply to the applied part described in theseinstructions for use.

Subsidiaries

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17 Subsidiaries

KARL STORZ SE & Co. KGDr.-Karl-Storz-Straße 34, 78532 Tuttlingen/GermanyPostfach 230, 78503 Tuttlingen/GermanyPhone: +49 (0)7461 708-0, Fax: +49 (0)7461 708-105E-Mail: info@karlstorz.com

KARL STORZ Endoskope Berlin GmbHScharnhorststr. 3, 10115 Berlin/GermanyPhone: +49 (0)30 30 69090, Fax: +49 (0)30 30 19452

KARL STORZ Endoscopy Canada Ltd.7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 CanadaPhone: +1 905 816-4500, Fax: +1 905 816-4599Toll free (Canada only) Phone: 1-800-268-4880, Fax: 1-800-482-4198(Canada only)E-Mail: info-canada@karlstorz.com

KARL STORZ Endoscopy-America, Inc.2151 East Grand Avenue, El Segundo, CA 90245-5017, USAPhone: +1 424 218-8100, Fax: +1 424 218-8525Toll free (USA only) Phone: 800 421-0837, Fax: 800 321-1304 (USA only)E-Mail: communications@ksea.com

KARL STORZ Veterinary Endoscopy-America, Inc.1 South Los Carneros Road, Goleta, CA 93117, USAPhone: +1 805 968-7776, Fax: +1 805 685-2588E-Mail: info@karlstorzvet.com

KARL STORZ Endoscopia Latino-America, Inc.815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USAPhone: +1 305 262-8980, Fax: +1 305 262-8986E-Mail: info@ksela.com

KARL STORZ Endoscopia México S.A. de C.V.Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna,CubaPhone: +537 836 95 06, Fax: +537 836 97 76E-Mail: kstorzcuba@gmail.com

KARL STORZ Endoscopia México S.A. de C.V.Lago Constanza No 326, Col. Granada, Del. Miguel Hidalgo, C.P. 11520 Ciu-dad de MéxicoPhone: +52 (55) 1101 1520E-Mail: mx-info@karlstorz.com

KARL STORZ Marketing América Do Sul Ltda.Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 SãoPaulo, BrasilPhone: +55 11 3526-4600, Fax: +55 11 3526-4680E-Mail: br-info@karlstorz.com

KARL STORZ Endoscopia Argentina S.A.Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de BuenosAires, ArgentinaPhone: +54 11 4718 0919, Fax: +54 11 4718 2773E-Mail: info@karlstorz.com.ar

KARL STORZ Endoskopi Norge ASStamveien1, 1483 Hagan, NorwayPhone: +47 6380 5600, Fax: +47 6380 5601E-Mail: post@karlstorz.no

KARL STORZ Endoskop Sverige ABStorsätragränd 14, 127 39 Skärholmen, SwedenPhone: +46 8 505 648 00E-Mail: kundservice@karlstorz.se

KARL STORZ Endoscopy Suomi OYTaivaltie 5, 01610 Vantaa, FinlandPhone: +358 (0)96824774, Fax: +358 (0)968247755E-Mail: asiakaspalvelu@karlstorz.fi

KARL STORZ SE & Co. KGRepresentation OfficeKęstučio st. 59 / Lenktoji st. 27, 08124 Vilnius, LithuaniaPhone: +370 5 272 0448, Mobile: +370 685 67 000E-Mail: info-lt-lv@karlstorz.com

KARL STORZ Endoskopi Danmark A/SSkovlytoften 33, 2840 Holte, DenmarkPhone: +45 45162600, Fax: +45 45162609E-Mail: marketing@karlstorz.dk

KARL STORZ Endoscopy (UK) Ltd.415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United KingdomPhone: +44 1753 503500, Fax: +44 1753 578124E-Mail: info-uk@karlstorz.com

KARL STORZ Endoscopie Nederland B. V.Displayweg 2, 3821 BT Amersfoort, NetherlandsPhone: +31 (0)33 4545890E-Mail: info-nl@karlstorz.com

KARL STORZ Endoscopy Belgium N. V.Phone: +31 (0)33 4545890E-Mail: info-be@karlstorz.com

KARL STORZ Endoscopie France S. A. S.12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, FrancePhone: +33 1 30484200, Fax: +33 1 30484201E-Mail: marketing-fr@karlstorz.com

KARL STORZ Endoskop Austria GmbHLandstraßer Hauptstr. 148/1/G1, 1030 Wien, AustriaPhone: +43 1 71 56 0470, Fax: +43 1 71 56 0479E-Mail: storz-austria@karlstorz.at

KARL STORZ Endoscopia Ibérica S. A.Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830Madrid, SpainPhone: +34 91 6771051, Fax: +34 91 6772981E-Mail: info-es@karlstorz.com

KARL STORZ Endoscopia Italia S. r. l.Via dell’Artigianato, 3, 37135 Verona, ItalyPhone: +39 045 8222000, Fax: +39 045 8222001E-Mail: info-ita@karlstorz.com

KARL STORZ Croatia d.o.o.Capraška 6, 10000 Zagreb, CroatiaPhone: +385 1 6406 070, Fax: +385 1 6406 077E-Mail: info@karlstorz.hr

KARL STORZ Endoskopija d.o.o.Cesta v Gorice 34b, 1000 Ljubljana, SloveniaPhone: +386 1 620 5880, Fax: + 386 1 620 5882E-Mail: pisarna@karlstorz.si

KARL STORZ Endoskop Polska Marketing Sp. z o.o.ul. Bojkowska 47, 44-100 Gliwice, PolandPhone: +48 32 706 13 00, Fax: +48 32 706 13 07E-Mail: info-pl@karlstorz.com

KARL STORZ Endoszkóp Magyarország Kft.Toberek utca 2. fsz. 17/b, HU-1112 Budapest, HungaryPhone: +36 195 096 31, Fax: +36 195 096 31E-Mail: info-hu@karlstorz.com

KARL STORZ Endoscopia Romania srlStr. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bucharest, RomaniaPhone: +40 (0)31 4250800, Fax: +40 (0)31 4250801E-Mail: info-ro@karlstorz.com

KARL STORZ Endoskope Greece M.E.P.E.*Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, GreecePhone: +30 2310 304868, Fax: +30 2310 304862E-Mail: info-gr@karlstorz.com*Repair & Service Subsidiary

Subsidiaries

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KARL STORZ Industrial**Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Is-tanbul, TurkeyPhone: +90 216 442 9500, Fax: +90 216 442 9030**Sales for Industrial Endoscopy

OOO KARL STORZ Endoskopy – WOSTOKDerbenyevskaya nab. 7, building 4, 115114 Moscow, RussiaPhone: +7 495 983 02 40, Fax: +7 495 983 02 41E-Mail: Info-ru@karlstorz.com

TOV KARL STORZ UkraineObolonska naberezhna, 15 building 3, office 3, 04210 Kiev, UkrainePhone: +380 44 42668-14, -15, -19 Fax: +380 44 42668-20E-Mail: marketing@karlstorz.com.ua

KARL STORZ SE & Co. KG Representation OfficeSabit Orudschow 1184, apt. 23, 1025 Baku, AzerbaijanPhone: +99 450 613 30 60E-Mail: info-az@karlstorz.com

KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L.Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,LebanonPhone: +961 1 501105, Fax: +961 1 501950E-Mail: info@karlstorz-emg.com

KARL STORZ Endoscopy (South Africa) (Pty) Ltd.P.O. 6061, Roggebaai, 8012 Cape Town, South AfricaPhone: +27 21 417 2600, Fax: +27 21 421 5103E-Mail: info@karlstorz.co.za

TOO KARL STORZ Endoskopy KasachstanSaryarka, 6, BC “Arman“, off. 910, 010000 Astana, Republic of KazakhstanPhone: +7 7172 552-549, 552-788, Fax: -444E-Mail: info@karlstorz.kz

KARL STORZ ENDOSKOPE East Mediterranean & Gulf (branch)Building West Side 7A – Unit 7WA – 3008, Dubai Airport Free Zone, P.O. Box54983, Dubai - United Arab EmiratesPhone: +971 (0)4 2958887, Fax: +971 (0)4 3205282Service Hotline: +971 (0)4 3415882E-Mail: info-gne@karlstorz-emg.com

KARL STORZ Endoscopy India Private Limited11th Floor, Dr. Gopal Das Bhawan, 28, Barakhamba Road, New Delhi110001, IndiaPhone: +91 11 4374 3000, Fax: +91 11 4374 3010E-Mail: corporate@karlstorz.in

KARL STORZ SE & CO. KGInterchange 21 Tower, Level 33, 399 Sukhumvit Road, North Klongtoey, Wat-tana, 10110 Bangkok, ThailandPhone: +84 28 3823 8000 Fax: +84 28 3823 8039E-Mail: infovietnam@karlstorz.com

KARL STORZ SE & Co. KGResident Representative Office14th Floor, MPlaza Saigon, 39 Le Duan, District 1, Ho Chi Minh City, VietnamPhone: +84 28 3823 8000, Fax: +84 28 3823 8039E-Mail: infovietnam@karlstorz.com

KARL STORZ Endoscopy China Ltd.Room 2503-05, 25F AXA Tower, Landmark East, No. 100 How Ming Street,Kwun Tong, Kowloon, Hong Kong, People’s Republic of ChinaPhone: +852 28 65 2411, Fax: +852 28 65 4114E-Mail: inquiry@karlstorz.com.hk

KARL STORZ Endoscopy (Shanghai) Ltd., Beijing BranchRoom 1805-1807, Building B, 18F Beijing IFC, No. 8, Jianguomenwai Street,Chaoyang District, 100022, Beijing, People’s Republic of ChinaPhone: +86 10 5638188, Fax: +86 10 5638199E-Mail: info@karlstorz.com.cn

KARL STORZ Endoscopy (Shanghai) Ltd., Shanghai BranchRoom 701A Building 5 & Room 501 Building 7, No. 3000 Longdong Avenue,Pilot Free Trade Zone, 201203, Shanghai, People’s Republic of ChinaPhone: +86 21 60339888, Fax: +86 21 60339808E-Mail: info@karlstorz.com.cn

KARL STORZ Endoscopy (Shanghai) Ltd., Chengdu BranchRoom 803-805, 8F Jin Jiang International Building, No. 1 West LinjiangRoad, Wuhou District, 6100414, Chengdu, People’s Republic of ChinaPhone: +86 28 86587977, Fax: +86 28 86587975E-Mail: info@karlstorz.com.cn

KARL STORZ Endoscopy (Shanghai) Ltd., Shenyang BranchRoom 2001-2005, 20F N-MEDIA International Center, No. 167 Youth Avenue,Shenhe District, 110014, Shenyang, People‘s Republic of ChinaPhone: +86 24 23181118, Fax: +86 24 23181119E-Mail: info@karlstorz.com.cn

KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou BranchRoom 02B & 03 & 04A, 35F Teem Tower, No. 208 Tianhe Road, Tianhe Dis-trict, 510620, Guangzhou, People’s Republic of ChinaPhone: +86 20 87321281, Fax: +86 20 87321286E-Mail: info@karlstorz.com.cn

KARL STORZ Endoscopy Asia Marketing Pte Ltd.No. 8 Commonwealth Lane #03-02, Singapore 149555, SingaporePhone: +65 69229150, Fax: +65 69229155E-Mail: infoasia@karlstorz.com

KARL STORZ Endoscopy Singapore Sales Pte LtdNo. 8 Commonwealth Lane #03-02, Singapore 149555, SingaporePhone: +65 69229150, Fax: +65 69229155E-Mail: infoasia@karlstorz.com

KARL STORZ Endoscopy Korea Co. Ltd.9F Hyowon-Building, 97, Jungdae-ro, Songpa-gu, 05719 Seoul, KoreaPhone: +82-70-4350-7474, Fax: +82-70-8277-3299E-Mail: infokorea@karlstorz.com

KARL STORZ Endoscopy Taiwan Ltd.12F, No. 192, Sec. 2, Chung Hsin Rd., Sindian District, New Taipei City, Tai-wanPhone: +886 933 014 160, Fax: +886 2 8672 6399E-Mail: info-tw@karlstorz.com

KARL STORZ SE & Co. KG Representative Office Philippines1901 Picadilly Star Bldg., 4th Avenue, BGC, Taguig City 1636, PhilippinesPhone: +63 2 317 45 00, Fax: +63 2 317 45 11E-Mail: phillippines@karlstorz.com

KARL STORZ Endoscopy Japan K. K.Stage Bldg. 8F, 2-7-2 Fujimi, Chiyoda-ku, Tokyo 102-0071, JapanPhone: +81 3 6380-8622, Fax: +81 3 6380-8633E-Mail: info@karlstorz.co.jp

KARL STORZ Endoscopy Australia Pty. Ltd .15 Orion Road Lane Cove NSW 2066, P O Box 50 Lane Cove NSW 1595,AustraliaPhone: +61 (0)2 9490 6700, Fax: +61 (0)2 9420 0695Toll free: 1800 996 562 (Australia only)E-Mail: info@karlstorz.au

www.karlstorz.com

Subsidiaries

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Subsidiaries

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KARL STORZ SE & Co. KG

KARL STORZ SE & Co. KGDr.-Karl-Storz-Straße 3478532 Tuttlingen

Postfach 23078503 TuttlingenGermany

Phone: +49 (0)7461 708-0Fax: +49 (0)7461 708-105E-Mail: info@karlstorz.com

www.karlstorz.com

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