Storz C-MAC 8403 Series User manual

Instruction For Use
C-MAC® Video Laryngoscope 8403xxx and
Connection Cable 8403X
en

© 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.: [phone]
Fax: [phone]
E-mail: [email protected]
www.karlstorz.com
12/2019

Table of contents
Instruction For Use • C-MAC® Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US •
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Table of contents
1 General information.......................................................................................................................................5
1.1 Reading the instructions for use ...............................................................................................................5
1.2 Scope........................................................................................................................................................5
2 Product description ......................................................................................................................................6
2.1 Product overview ......................................................................................................................................6
2.2 Packaging symbols...................................................................................................................................8
2.3 Symbols on the product ...........................................................................................................................8
3 Intended use .................................................................................................................................................9
3.1 Intended purpose......................................................................................................................................9
3.2 Contraindications......................................................................................................................................9
3.3 Target user populations ............................................................................................................................9
3.4 Training in the operation and function of the device ................................................................................9
3.5 Target patient populations........................................................................................................................ 9
3.6 User qualifications ....................................................................................................................................9
4 Safety ..........................................................................................................................................................11
4.1 Serious incidents ....................................................................................................................................11
4.2 Description of warnings ..........................................................................................................................11
4.3 Notes on use...........................................................................................................................................11
4.4 Unsterile instruments ..............................................................................................................................11
4.5 Correct reprocessing ..............................................................................................................................11
4.6 Risks from electric current ......................................................................................................................12
4.7 Risks due to damaged parts...................................................................................................................12
4.8 Damaged products .................................................................................................................................12
4.9 Combination with other devices and accessories ..................................................................................12
4.10 Damage to the instrument ......................................................................................................................12
5 Installation and commissioning...................................................................................................................14
5.1 Visual and functional test........................................................................................................................14
5.2 Initial operation .......................................................................................................................................15
6 Application ..................................................................................................................................................17
6.1 Connection to the C-MAC® monitor .......................................................................................................17
6.2 Connection to the C-MAC® pocket monitor ...........................................................................................18
6.2.1 Switching on the "Open-to-Intubate (OTI) displays" ................................................................... 19
6.2.2 Switching off the "Open to intubate" (OTI)-Displays ................................................................... 20
6.3 Connection to the C-Hub® II ...................................................................................................................21
6.4 Multifunctional button of the video laryngoscope ..................................................................................22
6.4.1 Color coding meanings for the "Blue Button" multifunction button............................................ 23
6.4.2 Single image capture................................................................................................................... 23
6.4.3 Video recording ........................................................................................................................... 23
6.4.4 Insertion of an oxygen or suction catheter (only with 8403 AX/BX/HX)....................................... 24
6.5 Disassembly............................................................................................................................................24
7 Reprocessing ..............................................................................................................................................25
7.1 Overview table (worldwide, does not apply to USA and Canada) ..........................................................25
7.2 General warnings (worldwide, does not apply to USA and Canada)......................................................25
7.3 Preparation for cleaning and disinfection ...............................................................................................27
7.4 Brushing the surfaces .............................................................................................................................27
7.5 Manual cleaning...................................................................................................................................... 27
7.6 Manual disinfection................................................................................................................................. 27
7.7 Machine cleaning and disinfection .........................................................................................................27
7.8 Assembly, inspection and care...............................................................................................................28
7.9 Packaging ...............................................................................................................................................28

Table of contents
Instruction For Use • C-MAC® Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US •
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7.10 Sterilization .............................................................................................................................................28
7.10.1 Hydrogen peroxide (H₂O₂) sterilization - ASP STERRAD®........................................................... 28
7.10.2 Hydrogen peroxide (H₂O₂) sterilization - STERIS® AMSCO® V-PRO™ 1 .................................... 29
7.10.3 Ethylene oxide sterilization (EO) .................................................................................................. 29
7.10.4 Chemical low-temperature sterilization with peracetic acid – STERIS® - System 1®.................. 29
7.10.5 Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E®.................. 29
7.11 Reprocessing limits.................................................................................................................................30
8 Reprocessing USA and Canada .................................................................................................................31
8.1 Overview table ........................................................................................................................................31
8.2 General warnings (applies only to USA and Canada) ............................................................................. 31
8.3 Brushing the surfaces .............................................................................................................................32
8.4 Water Quality Requirements ...................................................................................................................32
8.5 Pre-cleaning............................................................................................................................................32
8.6 Manual cleaning...................................................................................................................................... 32
8.7 Assembly, inspection and care...............................................................................................................33
8.8 Packaging ...............................................................................................................................................33
8.9 Sterilization .............................................................................................................................................33
8.9.1 Hydrogen peroxide (H₂O₂) sterilization - ASP STERRAD®........................................................... 33
8.9.2 Hydrogen peroxide (H₂O₂) sterilization - STERIS® AMSCO® V-PRO™ ....................................... 34
8.9.3 Ethylene oxide sterilization (EO) .................................................................................................. 34
8.9.4 Chemical low-temperature sterilization with peracetic acid – STERIS® System 1E®.................. 35
8.10 High-level disinfection.............................................................................................................................36
8.11 Reprocessing limits.................................................................................................................................36
9 Service and repair .......................................................................................................................................37
9.1 Servicing and repair program .................................................................................................................37
9.2 Complaint shipments ..............................................................................................................................37
10 Limitation of Liability ...................................................................................................................................38
11 Guarantee ...................................................................................................................................................39
12 Electromagnetic compatibility.....................................................................................................................40
13 Standards, directives and regulations ........................................................................................................41
13.1 Standards, directives and regulations ....................................................................................................41
13.2 Standard compliance..............................................................................................................................41
14 Disposal ......................................................................................................................................................42
15 Technical specifications..............................................................................................................................43
16 Fault correction ...........................................................................................................................................44
16.1 Troubleshooting ......................................................................................................................................44
17 Accessories and spare parts ......................................................................................................................46
17.1 Accessories.............................................................................................................................................46
18 Subsidiaries.................................................................................................................................................47

General information
Instruction For Use • C-MAC® Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US •
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1 General information
1.1 Reading the instructions for use
It is recommended that the suitability of the products for the planned procedure be checked
prior to use.
These instructions for use are intended to serve as an aid in the proper handling, cleaning and,
if need be, sterilization of the C-MAC® video laryngoscope and the monitor 8403 ZX. All of the
necessary details and actions are clearly explained. We thus ask that you read these
instructions carefully before proceeding to work with the instrument. Keep these instructions
available for ready reference.
If the instructions for use are not followed, patients, users, or third parties may be injured. In
addition, the device may be damaged.
1. Read the instructions for use carefully and follow them completely.
2. Keep the instructions for use clearly visible next to the product.
Note the instructions for use of the C-MAC® monitor (Art. No. 96076008D)!
1.2 Scope
These instructions for use are valid for the following models: C-MAC® video laryngoscope 8403
AX/BX/HX/ AXC/BXC/DXC/EXC/GXC/KXC/MXC/HXP in connection with the video connecting
cable 8403 X and monitor 8403 ZX or C-MAC® PM 8403 XD.
.

Product description
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2 Product description
2.1 Product overview

Product description
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**Models 8403 AXC/BXC/DXC/EXC/GXC/KXC/MXC/HXP
without guidance for suction catheter
* 8403 AX/BX/HX with guidance for suction catheter
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15 16 17
18
19
20
21
***
1
1 C-MAC® Video Laryngoscope 2 Socket for video connecting cable (4)
3 Multifunction button (BlueButton) 4 Video connecting cable
5 Connection socket on monitor 6 Connection socket on laryngoscope
7 C-MAC® Pocket-Monitor 8 TFT display
9 Coupling element 10 C-MAC® Monitor
11 Second connection for videoscope 12 Primary connection for videoscope
13 Mains power connection 14 Reset button
15 Holder for SD memory card 16 Status bar
17 Power switch lamp 18 On/Off switch
19 Charge control lamp (orange) 20 Soft keys
21 Function symbols 22 HDMI port
23 USB port

Product description
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2.2 Packaging symbols
Symbol Meaning
Consult the instructions for use
Keep away from sunlight
Keep dry
Temperature limit
In accordance with US federal law (21 CFR 801.109), this product may
only be sold to or on prescription from a licensed physician.
Humidity limitation
2.3 Symbols on the product
Symbol Meaning
Follow the instructions for use
Type BF device
Serial number

Intended use
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3 Intended use
3.1 Intended purpose
C-MAC® Video laryngoscopes:
Video laryngoscopes are used to visualize the airways and vocal cords during endotracheal
intubation and for the inspection and examination of the upper respiratory tract. Video
laryngoscopes are designed for transient use in invasive procedures through a body orifice.
3.2 Contraindications
No contraindications relating directly to the product are currently known. The use of the C-
MAC® video laryngoscope is contraindicated if, in the opinion of a responsible physician, the
health of the patient is endangered through its use, for example, due to the patient's general
condition, or if laryngoscopy as such is contraindicated.
3.3 Target user populations
The C-MAC® video laryngoscope may only be used by persons with an appropriate medical
qualification and who are acquainted with the laryngoscopy technique. The information in
these instructions for use is intended only to instruct in the correct handling, cleaning and
sterilization of the C-MAC® video laryngoscope, and is not suitable as an introduction to
laryngoscopy technique. The use of the C-MAC® video laryngoscopes must be used in
accordance with the airway algorithm in the respective country of application or the official
specifications for airway management.
3.4 Training in the operation and function of the device
Your local representative or responsible KARL STORZ member of staff is available to provide
training and information on further training alternatives.
3.5 Target patient populations
Gender No restriction
Age No restriction
Weight No restriction
Medical condition Suitable for the treatment, taking into account
the indications and contraindications, accord-
ing to the opinion of the physician
3.6 User qualifications
Only physicians and medical support staff with a relevant specialist qualification and who have
received training on the product may use the product. Only persons with appropriate specialist
training may provide training. The user profile includes the following features:
– Recognized medical qualification of the user (specialist physician, qualified medical staff)
– Adequate powers of comprehension to rationally assess the current surgical situation
– Adequate language skills in the languages used in the instructions for use
– Be thoroughly trained in the operation and use of the medical device
– Knowledge of the contents of the instructions for use

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

Safety
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4 Safety
4.1 Serious incidents
A "serious incident" includes, according to MDD incidents, those which, directly or indirectly,
had, could have had or could have any of the following consequences (MDD, Art. 2, No. 65 [1]):
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority should be notified of all serious incidents.
4.2 Description of warnings
To prevent any injury to persons or damage to property, the warning messages and safety
instructions in the instructions for use must be observed. The warnings describe the following
levels of danger.
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.
ATTENTION
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the product could be damaged.
4.3 Notes on use
Every user must be trained in the operation and use of the C-MAC® video laryngoscopes in
combination with a C-MAC® Monitor 8403 ZX or C-MAC® PM 8403 XD, otherwise they may not
be used.
The use of the C-MAC® video laryngoscopes together with a C-MAC® Monitor 8403ZX or C-
MAC® PM 8403XD must be used in accordance with the airway algorithm in the respective
country of application or the official specifications for airway management.
4.4 Unsterile instruments
These products are not sterile when delivered. The use of unsterile products poses a risk of
infection for patients, users, and third parties.
Reprocess products before first use.
Inspect products for visible contamination before use. Do not use contaminated products.
4.5 Correct reprocessing
Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection.

Safety
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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.
ðThis is not applicable to U.S. market.
4.6 Risks from electric current
If several products supplied with energy are used simultaneously, the patient leakage currents
accumulate. These leakage currents can exceed the limit values and injure patients.
Only use products of the same type, for example, endotherapy device and application part
of type CF.
4.7 Risks due to damaged parts
Check the following points before and after every use of the product:
1. Completeness
2. Good working order
3. Correct assembly of the components
4. Functionality
Inspect products for visible contamination before use. Do not use contaminated products.
Reprocess the products before use.
Do not leave missing or broken-off components inside the patient.
4.8 Damaged products
Damaged products can result in injury to patients, users, and third parties.
Before every use, check all components of the product for damage.
Do not use damaged products.
4.9 Combination with other devices and accessories
Combinations of medical devices are only assured to be safe if
– they are identified as such in the respective instructions for use or
– the intended use and interface specifications of the devices used in combination permit
this.
The use of unauthorized devices and accessories or unauthorized changes to the product can
result in injuries.
Additional devices connected to electrical medical equipment must comply with the relevant
IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, all
configurations must comply with the requirements for medical electrical systems (see IEC
60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1).
Anybody connecting additional equipment to medical electrical equipment is a system
configurator and is therefore responsible for the system's compliance with the standard
requirements for systems. Please note that local laws take priority over the above-mentioned
standard requirements. Should you have any queries, please contact your local specialist
dealer or the Technical Service (Standard/directive references: IEC 60601-1+A1+A2:1995:
6.8.2.c, 19.2.b, 19.2.c, IEC 60601-1:2005: 7.9.2.5, 8.1, 16.2.d, MDD 93/42/EEC: Annex I clause
13.6.c).
4.10 Damage to the instrument
– The C-MAC® video laryngoscopes may not be cleaned in an ultrasound bath.

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

Installation and commissioning
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5 Installation and commissioning
5.1 Visual and functional test
Visual inspection
11
The medical device must be inspected for completeness, damage and integrity before and
after every use. Tools such as a magnifying glass may be necessary to carry out the
inspections.
Missing components, surface changes or other damage to the medical device limit its life span
and may mean that the device can no longer be used for its intended purpose.
Check the instrument for:
– Mechanical damage and changes, for example, sharp edges, burred edges, rough
surfaces, protruding and bent parts (examples: Fig. 1 and 2)
2
– Signs of rust or corrosion
– Damage to the coating, such as shown in Fig. 3
3
– Complete and intact seals (that are not cracked, porous or swollen) and joints
– Residues and/or moisture present at the interfaces
– All components present and correctly positioned
– Mobility of all mobile components, if necessary once the components have been
assembled in the case of instruments that can be dismantled
– Complete, intact and securely positioned telescope and lens systems, e.g. with a
magnifying glass (examples Fig. 4 and 5)

Installation and commissioning
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4
5
Test for proper operation
Check the instrument for the following characteristics:
– Fully functional control keys
– Securely positioned connecting cable
– Functional image transmission
– Sufficient image quality
– Light transmission
5.2 Initial operation
The C-MAC® video laryngoscopes 8403 xxx can be operated with the following monitors:
– C-MAC® monitor 8403 ZX (software version: 704v300 or higher)
– C-MAC® PM Pocket-Monitor 8403 XD
– with other monitors via the camera control unit C-HUB® II 20 2903 01 (software version:
721v105 or higher)
WARNING
Danger due to user error in the wrong viewing mode
Wrong viewing mode
Before each use or after a change of viewing modes/settings, the user should check to
ensure the view observed through the endoscope provides a live image, rather than a
stored one, and has the correct image orientation.
The connecting cable can be removed during operation and connected to another
laryngoscope.
WARNING
Danger due to non-insulated parts
Risk of injury due to electrical current:
It must be ensured that the electrically non-insulated parts of the videoscope do not come
into contact with conductive surfaces, e.g., voltage-carrying elements of other units, at any
time.

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

Application
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6 Application
6.1 Connection to the C-MAC® monitor
The video laryngoscopes 8403 xxx can only be connected to the C-MAC® monitor 8403
ZX. Older monitor types (8402/8401 ZX) are not compatible.
1. Connect the video connecting cable (6) to the socket (2) of the video laryngoscope. The
orientation pin on the plug and socket facilitates connection.
2. Make sure that the cable is fully inserted. There must not be a visible gap.
2
6
Connect the video connecting cable coming from the video laryngoscope to the
connection socket (12) (primary connection) or the connection socket (11) of the C-MAC®
monitor.
11
12
The Monitor 8403 ZX enables two CMOS video units from KARL STORZ to be connected with
Lemo connectors. Video units from other manufacturers cannot be connected.

Application
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If two cameras are connected, the user must select the camera for which the images are to be
displayed in the menu (refer to the instruction manual for the C-MAC® monitor 8403 ZX Art. no.
96076008D).
Switch on the monitor by pressing the power switch (18). The green power switch lamp
(17) on the monitor and the blue multi-function button (3) of the video laryngoscope go on.
ðThe video laryngoscope is immediately ready to operate. As soon as the photo/video
recording function is ready, the multi-function button (3) goes on.
17
18
3
6.2 Connection to the C-MAC® pocket monitor
The 8403 xxx video laryngoscopes can only be connected to the C-MAC® PM 8403 XD.
The 8401XD model is not compatible.
Note the instruction manual of the C-MAC® PM 8403 XD (Art. No. 96076020D).
1. Connect the C-MAC® PM with the socket (2) of the video laryngoscope blade. The
orientation pin on the plug and socket facilitates connection.
2. Make sure that the plug is fully inserted. There must not be a visible gap.
3. The monitor can also be opened up when connecting both components.
ðThe video laryngoscope is immediately ready to operate. As soon as the photo/video
recording function is ready, the multi-function button (3) goes on.
2

Application
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3
When inserting the C-MAC® PM into the video laryngoscope always ensure that the lugs
of the plug connection are opposite each other.
6.2.1 Switching on the "Open-to-Intubate (OTI) displays"
If the C-MAC® PM is closed when connected to the video laryngoscope blade, the following
steps must be performed (Fig. A):
1. Fold the OTI display 8 upwards (Fig. B, C).
2. Turn the OTI display to the left (Fig. D).
3. Adjust the OTI display so that the image is optimally visible (Fig. E).

Application
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A
B
C
D
E
The image focus is adjusted automatically. Manual adjustment is not necessary.
The C-MAC® video laryngoscope with C-MAC® PM is ready for operation.
6.2.2 Switching off the "Open to intubate" (OTI)-Displays
1. Turn the OTI display (8) to the right (Fig. D).
2. Fold the OTI display to the right (Fig. C).
3. Fold the OTI display downwards (Fig. B).
4. The C-MAC® PM is switched off.