8401 XDK

en Instruction For Use
C-MAC® video laryngoscope 8401xxx, Electronic

Module 8401/8402 X, C-MAC® PM 8401 XD
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: info@karlstorz.com
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
Instruction For Use • C-MAC® video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC® PM 8401 3
XD • 96076011EN-US • V3.1
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
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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.
.
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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 C-
MAC® 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).
successfully subjected to a fall and crash test.
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Intended use
successfully tested on the MIL-STD-461F, RE102 (Fixed Wing).
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, accord-
ing 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
XD • 96076011EN-US • V3.1
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
4 6
5 12
9
6
2
1 **
1 *
* 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 elec- 2 Electronic module

tronic 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.
XD • 96076011EN-US • V3.1
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)
– 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.
XD • 96076011EN-US • V3.1
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.
XD • 96076011EN-US • V3.1
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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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.
XD • 96076011EN-US • V3.1
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.
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.
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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Reprocessing
7 Reprocessing
7.1 Cleaning and disinfection
CAUTION
Damage to the product!
Only perform reprocessing using chemicals approved by KARL STORZ. A list of approved
chemicals can be requested from hygiene@karlstorz.com.
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.
NOTE: The connector and the corresponding sockets in the laryngoscope and in the
electronic module are absolutely water-tight in all eventualities. All three connections are
also resistant to the process chemicals used in the validated reprocessing methods
employed. You may leave the connections unprotected during the validated reprocessing
procedures. In particular when the tray holder 39501 LC2 is used in a reprocessing
machine, no further accessories are needed.
CAUTION
Damage to the product
To prevent possible damage, these connections may only be fitted together when dry. If
reprocessing is carried out which does not provide for drying or where compressed air drying
cannot 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 and
validated 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-temperature
reprocessing 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.
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Reprocessing
CAUTION
Damage due to corrosion
The laryngoscope and electronic module are equipped with gold contacts that prevent
corrosion. However, particularly in the case of manual reprocessing, the contacts must be
thoroughly rinsed using microbiologically pure/sterile water when rinsed for the last time.
Afterwards, the contacts and the instrument must be carefully dried, preferably with sterile
compressed air.
7.2 Manual cleaning and disinfection

Start reprocessing the used instrument as soon as possible, since encrusted debris can cause
irreparable damage. Remove major debris using an active cleaner, e.g. tenside-based, and a
disinfected sponge or soft, disinfected brush.
Place in a disinfection solution; avoid air bubbles and ensure complete wetting. Follow the
chemical 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 disinfection

The choice of cleaning programs must be agreed with the washing machine manufacturer.
CAUTION
Clean and chemically disinfect the C-MAC® video laryngoscope in the washer-disinfector at a
maximum temperature of 65 °C. The temperature of the drying program must not exceed
65 °C.
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Reprocessing
Clean the optical surfaces of the image chip (8) and LED illuminator (7) on the C-MAC® video
laryngoscope with a cotton tip applicator soaked in 70% isopropyl alcohol.
Electrical contacts must be dried very carefully.
7.4 Overview table

Cleaning, disinfection and sterilization
Ultrasound
Manual
cleaning
and disin-
fection
Machine
cleaning
(65 °C)
Machine
cleaning
(93 °C)
Steam ster-
ilization
Gas steril-
ization
Hydrogen
peroxide
sterilization
Steris Sys-
tem 1®
C-MAC® X ● ●* X X ● ● ●
video
laryngo-
scopes
C-MAC® X ● ●* X X X X X
PM 8401
XD
Electronic X ● ●* X X ● ● X
Module
8401
X/8402 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 X
and the C-MAC® PM 8401 XD.
For sterilization with gas or with Steris System1®, country-specific laws and regulations
must be observed.
CAUTION
For sterilization in the Steris System 1® and Steris System 1E, the reprocessing cap 8401 YZ
must be put on first.
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Reprocessing
Chemically sterilize the C-MAC® video laryngoscope in dismantled condition.
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Service and repair
8 Service and repair

8.1 Servicing and repair program
Defective 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 be
returned to KARL STORZ as soon as you receive the repaired device. In Germany you can
refer repairs directly to:
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 shipments

In the interests of our employees' health, only sterilized or disinfected products are accepted
as return shipments. These should be marked as such; otherwise no further processing may be
performed.
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Limitation of Liability
9 Limitation of Liability
As a supplier of this instrument, we consider ourselves responsible for the safety, reliability and
performance of the instrument only if: Assembly, extension, new adjustments, changes or
repairs are carried out by persons authorized by KARL STORZ and the instrument is used in
accordance with the instructions for use.
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Guarantee
10 Guarantee
For information concerning the guarantees provided, please see the Standard Conditions of
Business 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 or
performance of any repairs or modifications to the equipment by unauthorized persons shall
relieve us of any liability for its performance. Any such opening, repair, or modification
performed during the warranty period shall void all warranty.
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Standards, directives and regulations
11 Standards, directives and regulations

11.1 Standards, directives and regulations
According to Medical Device Directive (MDD):
Class I medical devices. These medical devices bear the CE mark in accordance with the
Medical 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 camera
control 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
XD • 96076011EN-US • V3.1
Disposal
12 Disposal
This device has been marked in accordance with the European Directive on waste electrical
and electronic equipment (WEEE). At the end of its useful operating life, dispose of the unit as
electronic scrap. Please ask KARL STORZ SE & Co. KG, a KARL STORZ subsidiary or your
authorized dealer about the collection point in your area. Within the scope of application of this
directive, KARL STORZ SE & Co. KG is responsible for the proper disposal of this device.
National regulations/laws must be observed.
XD • 96076011EN-US • V3.1
Technical data
13 Technical data
Electronic 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

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 if
the recommended number of cycles is exceeded.
Inspect the device for damage before and after every use (see the chapter "Symbols and
danger 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%
XD • 96076011EN-US • V3.1
Technical data
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
XD • 96076011EN-US • V3.1
Fault correction
14 Fault correction
14.1 Troubleshooting
Always unplug the device before doing any cleaning and maintenance work on
the device.
WARNING
Symptom Possible causes Remedy

Complete failure of the de- – No power from the power – Check the power supply.
vice. Possible lighting up of line. – Push the power supply
status display. – Power cord connector is plug firmly into the socket
not properly connected to on the device.
device socket. – Reset.
– System error
No picture, TFT screen dark. – Electronic module/C- – Slide electronic module/
MAC® PM not fully C-MAC® PM in as far as it
inserted. will go.
– Defective camera – Send electronic module/
electronics. C-MAC® PM or supply
– TFT screen defective. unit to KARL STORZ for
repair.
Cloudy picture, stripes, – Telescope of the – Clean with cotton swab
streaks, or similar. laryngoscope is soiled. and alcohol solution or
– Contacts of the electronic special cleaning paste.
module/C-MAC® PM are – Clean the contacts of the
soiled. electronic module/C-
MAC® PM.
Color distortions. – White balance not carried – Carry out new white
out correctly. balance.
– Electronic module defect. – Send the supply unit for
repairs to KARL STORZ.
Color rendering alternates. – Camera connecting cable – Have a new camera
is defect. connecting cable fitted.
Image cannot be saved. – No memory card – Insert memory card.
inserted. – Change memory card.
– Memory card full. – Insert the memory card
– Memory card is not while the C-MAC®
recognized. Monitor is switched off
and then turn the monitor
on again.
– Perform a reset.
– Format the memory card
on the PC with FAT
(standard).
XD • 96076011EN-US • V3.1
Fault correction
Video stream cannot be – No MPEG-4 Codec – Install an MPEG-4 Codec

played back on the PC moni- installed. on the PC.
tor.
SD memory card cannot be – SD memory card is – Format the SD memory
written on. formatted incorrectly. card on the PC with FAT
(standard).
XD • 96076011EN-US • V3.1
Accessories and spare parts
15 Accessories and spare parts

15.1 Accessories
809125 MAGILL forceps, modified by  BOEDEKER,
length 25 cm, suitable for the endoscopic removal
of foreign bodies, for use with video laryngoscopes
of 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 with
video laryngoscopes of sizes 1 – 2
8402YE Bag for intubation set -C22-, model ULM,

made of water-repellent and hard-wearing surface
material, washable, the bag contains two compart-
ments with several holding possibilities for C-
MAC® video laryngoscopes with C-MAC® Pocket
Monitor and for conventional laryngoscopes, for
use with C-MAC® Pocket Monitor 8401 XDX, C-
MAC® video laryngoscopes and conventional
laryngoscopes
8401 YZ multifunctional cap for use in the Steris

System1® 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 and

storage for two C-MAC® video laryngoscope
blades incl. an electronic module, with holder for
fixing and sealing the electronic connections. Ex-
ternal dimensions (W x D x H): 260 x 120 x 170 mm
XD • 96076011EN-US • V3.1
Electromagnetic compatibility
16 Electromagnetic compatibility
The applied part described in these instructions for use has been tested as a system with the
following basic devices. For relevant electromagnetic compatibility (EMC) information, refer to
‘Electromagnetic Compatibility (EMC) information’ in the instructions for use for these basic
devices:
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 the
instructions for use for the basic devices also apply to the applied part described in these
instructions for use.
XD • 96076011EN-US • V3.1
Subsidiaries
17 Subsidiaries
KARL STORZ SE & Co. KG KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Representation Office
Postfach 230, 78503 Tuttlingen/Germany Kęstučio st. 59 / Lenktoji st. 27, 08124 Vilnius, Lithuania
Phone: +49 (0)7461 708-0, Fax: +49 (0)7461 708-105 Phone: +370 5 272 0448, Mobile: +370 685 67 000
E-Mail: info@karlstorz.com E-Mail: info-lt-lv@karlstorz.com
KARL STORZ Endoskope Berlin GmbH KARL STORZ Endoskopi Danmark A/S
Scharnhorststr. 3, 10115 Berlin/Germany Skovlytoften 33, 2840 Holte, Denmark
Phone: +49 (0)30 30 69090, Fax: +49 (0)30 30 19452 Phone: +45 45162600, Fax: +45 45162609
E-Mail: marketing@karlstorz.dk
KARL STORZ Endoscopy Canada Ltd.
7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada KARL STORZ Endoscopy (UK) Ltd.
Phone: +1 905 816-4500, Fax: +1 905 816-4599 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom
Toll free (Canada only) Phone: 1-800-268-4880, Fax: 1-800-482-4198 Phone: +44 1753 503500, Fax: +44 1753 578124
(Canada only) E-Mail: info-uk@karlstorz.com
E-Mail: info-canada@karlstorz.com
KARL STORZ Endoscopie Nederland B. V.
KARL STORZ Endoscopy-America, Inc. Displayweg 2, 3821 BT Amersfoort, Netherlands
2151 East Grand Avenue, El Segundo, CA 90245-5017, USA Phone: +31 (0)33 4545890
Phone: +1 424 218-8100, Fax: +1 424 218-8525 E-Mail: info-nl@karlstorz.com
Toll free (USA only) Phone: 800 421-0837, Fax: 800 321-1304 (USA only)
E-Mail: communications@ksea.com KARL STORZ Endoscopy Belgium N. V.
Phone: +31 (0)33 4545890
KARL STORZ Veterinary Endoscopy-America, Inc. E-Mail: info-be@karlstorz.com
1 South Los Carneros Road, Goleta, CA 93117, USA
Phone: +1 805 968-7776, Fax: +1 805 685-2588 KARL STORZ Endoscopie France S. A. S.
E-Mail: info@karlstorzvet.com 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France
Phone: +33 1 30484200, Fax: +33 1 30484201
KARL STORZ Endoscopia Latino-America, Inc. E-Mail: marketing-fr@karlstorz.com
815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA
Phone: +1 305 262-8980, Fax: +1 305 262-8986 KARL STORZ Endoskop Austria GmbH
E-Mail: info@ksela.com Landstraßer Hauptstr. 148/1/G1, 1030 Wien, Austria
Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479
KARL STORZ Endoscopia México S.A. de C.V. E-Mail: storz-austria@karlstorz.at
Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna,
Cuba KARL STORZ Endoscopia Ibérica S. A.
Phone: +537 836 95 06, Fax: +537 836 97 76 Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830
E-Mail: kstorzcuba@gmail.com Madrid, Spain
Phone: +34 91 6771051, Fax: +34 91 6772981
KARL STORZ Endoscopia México S.A. de C.V. E-Mail: info-es@karlstorz.com
Lago Constanza No 326, Col. Granada, Del. Miguel Hidalgo, C.P. 11520 Ciu-
dad de México KARL STORZ Endoscopia Italia S. r. l.
Phone: +52 (55) 1101 1520 Via dell’Artigianato, 3, 37135 Verona, Italy
E-Mail: mx-info@karlstorz.com Phone: +39 045 8222000, Fax: +39 045 8222001
E-Mail: info-ita@karlstorz.com
KARL STORZ Marketing América Do Sul Ltda.
Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São KARL STORZ Croatia d.o.o.
Paulo, Brasil Capraška 6, 10000 Zagreb, Croatia
Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 Phone: +385 1 6406 070, Fax: +385 1 6406 077
E-Mail: br-info@karlstorz.com E-Mail: info@karlstorz.hr
KARL STORZ Endoscopia Argentina S.A. KARL STORZ Endoskopija d.o.o.

Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de Buenos Cesta v Gorice 34b, 1000 Ljubljana, Slovenia
Aires, Argentina Phone: +386 1 620 5880, Fax: + 386 1 620 5882
Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 E-Mail: pisarna@karlstorz.si
E-Mail: info@karlstorz.com.ar KARL STORZ Endoskop Polska Marketing Sp. z o.o.
KARL STORZ Endoskopi Norge AS ul. Bojkowska 47, 44-100 Gliwice, Poland
Stamveien1, 1483 Hagan, Norway Phone: +48 32 706 13 00, Fax: +48 32 706 13 07
Phone: +47 6380 5600, Fax: +47 6380 5601 E-Mail: info-pl@karlstorz.com
E-Mail: post@karlstorz.no KARL STORZ Endoszkóp Magyarország Kft.
KARL STORZ Endoskop Sverige AB Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary
Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +36 195 096 31, Fax: +36 195 096 31
Phone: +46 8 505 648 00 E-Mail: info-hu@karlstorz.com
E-Mail: kundservice@karlstorz.se KARL STORZ Endoscopia Romania srl
KARL STORZ Endoscopy Suomi OY Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bucharest, Romania
Taivaltie 5, 01610 Vantaa, Finland Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801
Phone: +358 (0)96824774, Fax: +358 (0)968247755 E-Mail: info-ro@karlstorz.com
E-Mail: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.*
Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece
Phone: +30 2310 304868, Fax: +30 2310 304862
E-Mail: info-gr@karlstorz.com
*Repair & Service Subsidiary
XD • 96076011EN-US • V3.1
Subsidiaries
KARL STORZ Industrial** KARL STORZ Endoscopy (Shanghai) Ltd., Chengdu Branch
Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Is- Room 803-805, 8F Jin Jiang International Building, No. 1 West Linjiang
tanbul, Turkey Road, Wuhou District, 6100414, Chengdu, People’s Republic of China
Phone: +90 216 442 9500, Fax: +90 216 442 9030 Phone: +86 28 86587977, Fax: +86 28 86587975
**Sales for Industrial Endoscopy E-Mail: info@karlstorz.com.cn
OOO KARL STORZ Endoskopy – WOSTOK KARL STORZ Endoscopy (Shanghai) Ltd., Shenyang Branch
Derbenyevskaya nab. 7, building 4, 115114 Moscow, Russia Room 2001-2005, 20F N-MEDIA International Center, No. 167 Youth Avenue,
Phone: +7 495 983 02 40, Fax: +7 495 983 02 41 Shenhe District, 110014, Shenyang, People‘s Republic of China
E-Mail: Info-ru@karlstorz.com Phone: +86 24 23181118, Fax: +86 24 23181119
E-Mail: info@karlstorz.com.cn
TOV KARL STORZ Ukraine
Obolonska naberezhna, 15 building 3, office 3, 04210 Kiev, Ukraine KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou Branch
Phone: +380 44 42668-14, -15, -19 Fax: +380 44 42668-20 Room 02B & 03 & 04A, 35F Teem Tower, No. 208 Tianhe Road, Tianhe Dis-
E-Mail: marketing@karlstorz.com.ua trict, 510620, Guangzhou, People’s Republic of China
Phone: +86 20 87321281, Fax: +86 20 87321286
KARL STORZ SE & Co. KG Representation Office E-Mail: info@karlstorz.com.cn
Sabit Orudschow 1184, apt. 23, 1025 Baku, Azerbaijan
Phone: +99 450 613 30 60 KARL STORZ Endoscopy Asia Marketing Pte Ltd.
E-Mail: info-az@karlstorz.com No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
Phone: +65 69229150, Fax: +65 69229155
KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. E-Mail: infoasia@karlstorz.com
Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,
Lebanon KARL STORZ Endoscopy Singapore Sales Pte Ltd
Phone: +961 1 501105, Fax: +961 1 501950 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
E-Mail: info@karlstorz-emg.com Phone: +65 69229150, Fax: +65 69229155
E-Mail: infoasia@karlstorz.com
KARL STORZ Endoscopy (South Africa) (Pty) Ltd.
P.O. 6061, Roggebaai, 8012 Cape Town, South Africa KARL STORZ Endoscopy Korea Co. Ltd.
Phone: +27 21 417 2600, Fax: +27 21 421 5103 9F Hyowon-Building, 97, Jungdae-ro, Songpa-gu, 05719 Seoul, Korea
E-Mail: info@karlstorz.co.za Phone: +82-70-4350-7474, Fax: +82-70-8277-3299
E-Mail: infokorea@karlstorz.com
TOO KARL STORZ Endoskopy Kasachstan
Saryarka, 6, BC “Arman“, off. 910, 010000 Astana, Republic of Kazakhstan KARL STORZ Endoscopy Taiwan Ltd.
Phone: +7 7172 552-549, 552-788, Fax: -444 12F, No. 192, Sec. 2, Chung Hsin Rd., Sindian District, New Taipei City, Tai-
E-Mail: info@karlstorz.kz wan
Phone: +886 933 014 160, Fax: +886 2 8672 6399
KARL STORZ ENDOSKOPE East Mediterranean & Gulf (branch) E-Mail: info-tw@karlstorz.com
Building West Side 7A – Unit 7WA – 3008, Dubai Airport Free Zone, P.O. Box
54983, Dubai - United Arab Emirates KARL STORZ SE & Co. KG Representative Office Philippines
Phone: +971 (0)4 2958887, Fax: +971 (0)4 3205282 1901 Picadilly Star Bldg., 4th Avenue, BGC, Taguig City 1636, Philippines
Service Hotline: +971 (0)4 3415882 Phone: +63 2 317 45 00, Fax: +63 2 317 45 11
E-Mail: info-gne@karlstorz-emg.com E-Mail: phillippines@karlstorz.com
KARL STORZ Endoscopy India Private Limited KARL STORZ Endoscopy Japan K. K.
11th Floor, Dr. Gopal Das Bhawan, 28, Barakhamba Road, New Delhi Stage Bldg. 8F, 2-7-2 Fujimi, Chiyoda-ku, Tokyo 102-0071, Japan
110001, India Phone: +81 3 6380-8622, Fax: +81 3 6380-8633
Phone: +91 11 4374 3000, Fax: +91 11 4374 3010 E-Mail: info@karlstorz.co.jp
E-Mail: corporate@karlstorz.in
KARL STORZ Endoscopy Australia Pty. Ltd .
KARL STORZ SE & CO. KG 15 Orion Road Lane Cove NSW 2066, P O Box 50 Lane Cove NSW 1595,
Interchange 21 Tower, Level 33, 399 Sukhumvit Road, North Klongtoey, Wat- Australia
tana, 10110 Bangkok, Thailand Phone: +61 (0)2 9490 6700, Fax: +61 (0)2 9420 0695
Phone: +84 28 3823 8000 Fax: +84 28 3823 8039 Toll free: 1800 996 562 (Australia only)
E-Mail: infovietnam@karlstorz.com E-Mail: info@karlstorz.au
KARL STORZ SE & Co. KG www.karlstorz.com

Resident Representative Office
14th Floor, MPlaza Saigon, 39 Le Duan, District 1, Ho Chi Minh City, Vietnam
Phone: +84 28 3823 8000, Fax: +84 28 3823 8039
E-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 China
Phone: +852 28 65 2411, Fax: +852 28 65 4114
E-Mail: inquiry@karlstorz.com.hk
KARL STORZ Endoscopy (Shanghai) Ltd., Beijing Branch

Room 1805-1807, Building B, 18F Beijing IFC, No. 8, Jianguomenwai Street,
Chaoyang District, 100022, Beijing, People’s Republic of China
Phone: +86 10 5638188, Fax: +86 10 5638199
KARL STORZ Endoscopy (Shanghai) Ltd., Shanghai Branch

Room 701A Building 5 & Room 501 Building 7, No. 3000 Longdong Avenue,
Pilot Free Trade Zone, 201203, Shanghai, People’s Republic of China
Phone: +86 21 60339888, Fax: +86 21 60339808
XD • 96076011EN-US • V3.1
Subsidiaries
XD • 96076011EN-US • V3.1
Subsidiaries
XD • 96076011EN-US • V3.1
Dr.-Karl-Storz-Straße 34
96076011EN-US • V3.1 • 11/2019
78532 Tuttlingen
Postfach 230
78503 Tuttlingen
Germany
Phone: +49 (0)7461 708-0
Fax: +49 (0)7461 708-105
E-Mail: info@karlstorz.com
www.karlstorz.com

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en Instruction For Use

C-MAC® video laryngoscope 8401xxx, Electronic

2.3 Target user populations

2.4 User qualifications

2.5 Safety precautions when using the C-MAC® video

2.6 Safety precautions when using the C-MAC® PM

2.7 Training in the operation and function of the device

2.8 Target patient populations

3.2 Description of warnings

3.3 Unsterile instruments

3.4 Correct reprocessing

3.5 Risks due to damaged parts

3.6 Combination with other devices and accessories

3.7 Damage to the instrument

3.8 Damaged products

3.9 Allergic reactions

* Models 8401 AXC/BXC/DXC/GXC/KXC/HXP ** 8401 AX/BX/HX with guidance for suction

1 Laryngoscope blade with holder for elec- 2 Electronic module

4.2 Packaging symbols

Keep away from sunlight

4.3 Symbols on the product

4.4 Charging Unit for C-MAC® PM

1. Insert the C-MAC® PM into the charging compartment.

3. Test for proper operation.

5 Installation and commissioning

– Signs of rust or corrosion

Test for proper operation

5.2 Initial operation

5.2.1 Operating the C-MAC® PM

Switching on the Open-to-Intubate (OTI) display

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

Switching off the Open to intubate (OTI) display

It is not necessary to perform a white balance.

5.2.2 Energy management

5.2.3 Putting the electronic module into service

6.2 Monitor function keys

6.3 Insertion of an oxygen or suction catheter (only with

6.5 C-MAC® bag 8403 YD

7.2 Manual cleaning and disinfection

7.3 Machine cleaning and disinfection

7.4 Overview table

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

8 Service and repair

8.2 Complaint shipments

11 Standards, directives and regulations

11.2 Standard compliance

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

Average life cycle

Charging station 8401 XDL

Symptom Possible causes Remedy

Video stream cannot be – No MPEG-4 Codec – Install an MPEG-4 Codec

15 Accessories and spare parts

809120 MAGILL forceps, for children, modified by

8402YE Bag for intubation set -C22-, model ULM,

8401 YZ multifunctional cap for use in the Steris

39501 LC2 wire tray for cleaning, sterilization and

Basic device Instructions for use

KARL STORZ Endoscopia Argentina S.A. KARL STORZ Endoskopija d.o.o.

KARL STORZ SE & Co. KG www.karlstorz.com

KARL STORZ Endoscopy China Ltd.

KARL STORZ Endoscopy (Shanghai) Ltd., Beijing Branch

KARL STORZ Endoscopy (Shanghai) Ltd., Shanghai Branch

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