Storz 8404 Series User manual

Instructions for use
C-MAC Video Laryngoscopes Series 8404
en

Copyright ©
All product illustrations, product descriptions, and texts are the intellectual property of
KARLSTORZSE&Co.KG.
Their use and reproduction by third parties require the express approval of
KARLSTORZSE&Co.KG.
All rights reserved.
11-2021

Table of contents
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 3
Table of contents
1 General information .................................................................................................................. 5
1.1 Read the instructions for use........................................................................................... 5
1.2 Read the instructions for use of compatible products .................................................... 5
1.3 Scope .............................................................................................................................. 5
1.4 General signs and symbols ............................................................................................. 5
1.5 Description of warning messages ................................................................................... 6
2 Normal use ............................................................................................................................... 7
2.1 Intended use.................................................................................................................... 7
2.2 Indications for use ........................................................................................................... 7
2.3 Contraindications ............................................................................................................ 7
2.4 Target user populations................................................................................................... 7
2.5 Patient groups ................................................................................................................. 7
3 Safety ....................................................................................................................................... 8
3.1 Serious incidents ............................................................................................................. 8
3.2 Correct handling and product testing ............................................................................. 8
3.3 Unsterile product ............................................................................................................. 8
3.4 Combination with other components .............................................................................. 8
3.5 Electromagnetic interference........................................................................................... 9
3.6 Patient leakage current.................................................................................................... 9
3.7 National guidelines on airway management.................................................................... 9
3.8 Hot components.............................................................................................................. 9
3.9 High light intensity ........................................................................................................... 10
4 Product description.................................................................................................................. 11
4.1 Product overview............................................................................................................. 11
4.2 Possible combinations .................................................................................................... 12
4.3 Technical specifications .................................................................................................. 12
4.4 Symbols employed .......................................................................................................... 13
4.4.1 Symbols on the packaging ................................................................................. 13
4.4.2 Symbols on the product ..................................................................................... 14
4.5 Ambient conditions.......................................................................................................... 14
5 Preparation ............................................................................................................................... 15
5.1 Unpacking the product.................................................................................................... 15
5.2 Testing the product ......................................................................................................... 15
5.2.1 Visual inspection................................................................................................. 15
5.2.2 Functional test .................................................................................................... 16
5.3 Connecting the C-MAC Monitor...................................................................................... 16
5.4 Connecting the C-MAC Pocket Monitor ......................................................................... 17
5.5 Connecting the C-HUB II................................................................................................. 19
6 Application................................................................................................................................ 20
6.1 Using the product............................................................................................................ 20
6.2 Inserting an oxygen catheter or suction catheter ............................................................ 21
7 Disassembly ............................................................................................................................. 22
7.1 Disassembling the product.............................................................................................. 22
8 Maintenance, servicing, repairs, and disposal ......................................................................... 23

Table of contents
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 4
8.1 Repairing the product...................................................................................................... 23
8.2 Disposing of the product ................................................................................................. 23
9 Accessories and spare parts.................................................................................................... 24
9.1 Accessories ..................................................................................................................... 24
10 Electromagnetic compatibility .................................................................................................. 25
10.1 General information ......................................................................................................... 25
11 Errors and messages................................................................................................................ 26
11.1 Product malfunctions ...................................................................................................... 26
12 Subsidiaries .............................................................................................................................. 27

General information
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 5
1 General information
1.1 Read the instructions for use
If the instructions for use are not followed, patients, users, and third parties may be injured or
the product may be damaged.
Read the instructions for use carefully and follow all the safety notes and warnings.
Read the reprocessing instructions carefully and follow all the safety notes and warnings.
The reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering
the item number.
Keep the instructions for use and reprocessing instructions in a safe place.
1.2 Read the instructions for use of compatible products
If the instructions for use of compatible products are not followed, patients, users, and third
parties may be injured or the product may be damaged.
Read the instructions for use of the compatible products carefully and follow all the safety
notes and warnings.
Read the reprocessing instructions of the compatible products carefully and follow all the
safety notes and warnings.
1.3 Scope
This instruction manual is valid for:
Product name Item number
C-MAC video laryngoscope 8404AX
8404AXC
8404BX
8404BXC
8404DXC
8404EXC
8404GXC
8404HX
8404HXP
8404KXC
8404MXC
Video connecting cable 8403X
1.4 General signs and symbols
The signs and symbols used in this document have the following meaning:
Practical tip
This sign refers to useful and important information.

General information
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 6
Actions to be performed
Action to be carried out by several steps:
üPrerequisite that must be met before carrying out an action.
1. Step 1
ðInterim result of an action
2. Step 2
ðResult of a completed action
Actions in safety notes or in the case of a single step:
Step 1
Lists
1. Numbered list
– Unnumbered list, 1st level
– Unnumbered list, 2nd level
1.5 Description of warning messages
To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warnings use 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.
NOTICE
NOTICE
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Normal use
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 7
2 Normal use
2.1 Intended use
Video laryngoscopes
Video laryngoscopes (CMOS) are used for visualizing the respiratory tracts and vocal cords
during endotracheal intubation and for the inspection and examination of the upper respiratory
tract. Video laryngoscopes (CMOS) are designed for transient use in invasive procedures
through a body orifice.
C-MAC Monitor accessories
C-MAC Monitor accessories are used for transmitting energy. C-MAC Monitor accessories are
used in conjunction with the C-MAC system for visualizing the respiratory tracts and vocal
cords during endotracheal intubation and for inspecting and examining the upper respiratory
tracts. C-MAC Monitor accessories are non-invasive and are designed for transient use in
invasive procedures through a body orifice.
2.2 Indications for use
The use of laryngoscopes and video laryngoscopes is indicated if, in the opinion of the
responsible physician, inspection of the upper respiratory tract or endotracheal intubation is
indicated.
2.3 Contraindications
The use of laryngoscopes and video laryngoscopes is contraindicated if, in the opinion of the
responsible physician, use is contraindicated or the patient is not able to undergo surgery or
anesthesia due to his or her general condition. Laryngoscopes and video laryngoscopes must
not be used for procedures in direct contact with the central nervous system (CNS) and central
cardiovascular system.
2.4 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.
2.5 Patient groups
There are no restrictions in terms of patient groups for this product.

Safety
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 8
3 Safety
3.1 Serious incidents
A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or
could have any of the following consequences:
– 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 must be notified of all serious incidents.
3.2 Correct handling and product testing
If the product is not handled correctly, patients, users, and third parties may be injured.
Only persons with the necessary medical qualification and who are acquainted with the
application of the product may work with it.
Check that the product is suitable for the procedure prior to use.
Check the product for the following properties, for example, before and after every use:
– Functionality
– Damage
– Changes to the surface
For detailed inspection criteria, see section Inspecting the product.
Do not continue to use damaged products.
Dispose of the product properly.
3.3 Unsterile product
The product is not sterile when delivered. The use of non-sterile products poses a risk of
infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.4 Combination with other components
The use of unauthorized devices and components 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. 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).
Only combine the product with devices and components that are approved for combined
use by the manufacturer.
Comply with national and local regulations.
Observe the instruction manuals and interface specifications of the devices and
components used in combination.
Only use devices and components that have standardized interfaces and do not breach
the intended use of the product.
Only make changes to the product if these changes are approved by KARLSTORZ.

Safety
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 9
3.5 Electromagnetic interference
Medical electrical products are subject to special precautions regarding electromagnetic
compatibility and must be installed and commissioned according to the tables on
electromagnetic compatibility. If other products (e.g. for MRT, CT, diathermy, electrocautery, or
RFID) emit electromagnetic radiation, the function of the product may be impaired. High-
frequency communication equipment can affect electrical medical products and impair their
performance.
Do not use the product in the vicinity of a magnetic resonance tomograph (MRT).
Do not use the product next to or together with other devices. If such use is required,
monitor the product and the other devices, and follow the relevant instructions for use in
the event of malfunctions.
Portable RF communications equipment including peripheral devices (e.g., antenna cables
and external antennas) should be used no closer than 30cm from the product, including
cables specified by the manufacturer.
Observe the information on electromagnetic compatibility, see chapter Electromagnetic
compatibility [p.25].
In case of uncertainties, seek expert advice from KARLSTORZ.
Before use, a clinical/biomedical engineer or an EMC specialist should carry out an ad-hoc
test of the electromagnetic radiation.
The use of accessories and cables other than those specified in the instruction manual may
result in increased emissions or decreased immunity of the product. When using other
accessories and cables, the operator is responsible for checking compliance with IEC
60601-1-2 for this particular product.
To prevent increased electromagnetic emissions or reduced electromagnetic immunity of
the product, only use accessories, transducers, and cables recommended or supplied by
the manufacturer.
3.6 Patient leakage current
If several products supplied with energy are used simultaneously, the patient leakage currents
of the product can accumulate. Excessively high leakage current levels may result in the
patient becoming injured.
Only use products of the same type together, particularly if CF products are required.
If the product is connected to a type BF generator, the product will also correspond to
type BF.
3.7 National guidelines on airway management
Failure to observe the national guidelines on airway management may put the patient at risk.
National guidelines on airway management must be observed in addition to the
documentation accompanying the product.
3.8 Hot components
The high level of light intensity produced by the light source may cause the distal end, the light
connections, and adjacent components to heat up. This can cause burns to patients, users,
and third parties.
Set the output of the adjustable light sources to a level that is just high enough to ensure
optimal illumination of the operating area.
Prevent the distal end, light connections, and adjacent components from coming into
contact with tissue and operating room accessories.

Safety
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 10
3.9 High light intensity
The high level of light intensity produced by the light source may lead to permanent eye
damage or blindness, and may cause tissue and items facing the light output to heat up.
Do not look into the light output.
Set the output of the adjustable light sources to a level that is just high enough to ensure
optimal illumination of the operating area.
Make sure the light output is sufficiently far away from tissue and operating accessories.

Product description
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 11
4 Product description
4.1 Product overview
1
2
Video laryngoscope (e.g., 8404HX)
1 Socket for video connecting cable 2 Multifunction button
Video laryngoscope (e.g., 8404BXC) with C-MAC Pocket Monitor

Product description
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 12
2
1
Video connecting cable (8403X)
1 Video unit connector 2 Monitor connector
4.2 Possible combinations
It is recommended that the suitability of the products for the intended procedure be checked
prior to use. Please note that the products listed here may not yet be available in all countries
due to differences in approval requirements.
The product can be combined with the following monitors:
C-MAC video laryngo-
scopes
Monitor
Series 8404 8403ZX (software version: 704v300 or higher)
8404ZX
8403XD
The series8404 C-MACvideo laryngoscopes can be combined with other monitors via the C-
HUBII camera control unit (20290320) (software version: 721v105 or higher).
The product can be combined with the following catheters:
C-MAC video laryngo-
scopes
Blade Catheter
Series 8404 8404AX 14Fr.
16Fr.
8404HX 16Fr.
18Fr.
8404BX
4.3 Technical specifications
Designation Value
Immersion protection IP68
Camera technology CMOS
Resolution 1,280x800pixels
Illumination 2 x LED, white, 1W

Product description
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 13
4.4 Symbols employed
4.4.1 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Batch code
Number of products in the product packaging
Unique Device Identifier
Consult the printed or electronic instructions for use
Federal (USA) law restricts this device to sale by or on the order of a
physician.
CE marking
With this marking, the manufacturer declares the conformity of the prod-
uct with the applicable EU directives. A code number after the CE mark
indicates the responsible notified body.
The EU legislation relevant to the product can be found in the EU Decla-
ration of Conformity, which can be requested from KARL STORZ.

Product description
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 14
4.4.2 Symbols on the product
Symbol Meaning
IP68 Protection class IP68
Serial number
CE marking
With this marking, the manufacturer declares the conformity of the prod-
uct with the applicable EU directives. A code number after the CE mark
indicates the responsible notified body.
The EU legislation relevant to the product can be found in the EU Decla-
ration of Conformity, which can be requested from KARL STORZ.
4.5 Ambient conditions
Storage and transport conditions
Temperature -20°C...+50°C (-4°F...+122°F)
Relative humidity
(non-condensing)
5–85%
Operating conditions
Temperature 0°C...40°C (32°F...104°F)
Relative humidity
(non-condensing)
30–70%
Air pressure 700–1,080hPa

Preparation
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 15
5 Preparation
5.1 Unpacking the product
1. Carefully remove the product and accessories from the packaging.
2. Check the delivery for missing items and any possible damage.
3. In the case of damage, hidden defects, and short deliveries, document their nature and
extent and contact the manufacturer or supplier immediately.
5.2 Testing the product
5.2.1 Visual inspection
Missing components, surface changes, or other damage limit the life span of the product and
may mean that the product can no longer be used for its intended use.
1. The product must be inspected for completeness, damage, and integrity before and after
every use. Inspection tools such as magnifying glasses should be used as necessary.
2. Check for the following types of mechanical damage and changes:
– Sharp corners
– Burred edges
– Rough surfaces
– Protruding or bent parts
– Rust or corrosion
Defect pattern: Blade tip bent
Defect pattern: Blade roof bent

Preparation
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 16
3. Ensure that the components and connections are complete, intact, and positioned
correctly.
Defect pattern: Defective socket, damaged multifunction button
4. Check whether there are residues or moisture at the interfaces.
5. Use a magnifying glass to check that the optics is complete, intact, and securely
positioned.
5.2.2 Functional test
Inspect the product for the following characteristics:
– Fully functional control keys
– Securely positioned connecting cable
– Functional image transmission
– Sufficient image quality
– Light transmission
5.3 Connecting the C-MAC Monitor
1. Insert the video connecting cable into the socket of the video laryngoscope. Pay
attention to the orientation pin on the plug and socket.

Preparation
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 17
2. Make sure that the cable is fully inserted.
3. Connect the other end of the video connecting cable to the socket on the
C-MACMonitor.
4. Alternatively, connect the other end of the video connecting cable to the socket on the
rear side.
Another laryngoscope can be connected during use.
5.4 Connecting the C-MAC Pocket Monitor
The Pocket Monitor can be connected to the product while folded up or down.

Preparation
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 18
1. Connect the C-MACPocketMonitor to the socket of the video laryngoscope. Pay
attention to the orientation pin on the plug and socket.
2. Make sure that the orientation pins are opposite each other and the plug is fully inserted.
ðAs soon as the recording function is ready, the multifunction button lights up blue.
The monitor can be removed and connected to another laryngoscope during use.

Preparation
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 19
5.5 Connecting the C-HUB II
1. Connect the video connecting cable to the socket of the video laryngoscope. Pay
attention to the orientation pin on the plug and socket.
2. Make sure that the cable is fully inserted.
3. Connect the power supply unit to the C-HUBII.
4. Connect the video connecting cable to the video input on the front of the C-HUBII.

Application
Instructions for use • C-MAC Video Laryngoscopes Series 8404 • USB826_EN_V1.2_11-2021_IFU_CE-MDR 20
6 Application
6.1 Using the product
WARNING
Wrong viewing mode! Risk of injury!
If the viewing mode settings are changed, this can alter the image display and image position.
Before each use, check whether a live image or a saved image is being displayed and
whether a correct image position has been selected.
Documentation can be carried out on the C-MACMonitor(8403ZX, 8404ZX) and
C-MACPocketMonitor(8403XD) using the multifunction button on the video laryngoscope.
1. Switch on the product in good time so that the optical system can warm up.
2. Switch on the monitor.
ðAs soon as the recording function is ready, the multifunction button lights up blue.
3. Press the multifunction button briefly to save images individually.
ðThe multifunction button lights up green during the saving process.