Storz C-MAC 8403 Series User manual

Instructions for use
C-MAC® Video Laryngoscopes Series 8403
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.
04-2021

Table of contents
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_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 combinable products............................................................................. 5
1.3 Scope........................................................................................................................................................5
1.4 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 .......................................................................................................................................8
3.3 Unsterile product ......................................................................................................................................8
3.4 Damaged products ...................................................................................................................................8
3.5 Combination with other components .......................................................................................................9
3.6 Electromagnetic interference ....................................................................................................................9
3.7 Patient leakage current ........................................................................................................................... 10
3.8 National guidelines on airway management ...........................................................................................10
3.9 Hot components .....................................................................................................................................10
3.10 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 ............................................................................................................................. 17
5.3 Connecting the C-MAC® Monitor ...........................................................................................................17
5.4 Connecting the C-MAC® Pocket Monitor ...............................................................................................19
5.5 Connecting C-Hub® II .............................................................................................................................20
6 Application ..................................................................................................................................................21
6.1 Using the product ...................................................................................................................................21
6.2 Inserting an oxygen or suction catheter .................................................................................................21
7 Disassembly................................................................................................................................................23
7.1 Disassembling the product ..................................................................................................................... 23
8 Maintenance, servicing, repairs, and disposal............................................................................................24
8.1 Repairs to the product ............................................................................................................................ 24
8.2 Disposing of the product ........................................................................................................................24
9 Accessories and spare parts ......................................................................................................................25
9.1 Accessories.............................................................................................................................................25
10 Electromagnetic compatibility.....................................................................................................................26
10.1 Electromagnetic compatibility ................................................................................................................26

Table of contents
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 4
11 Fault correction ...........................................................................................................................................27
11.1 Product malfunctions..............................................................................................................................27
12 Subsidiaries.................................................................................................................................................28

General information
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_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.
Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products
If the instructions for use of combinable 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 combinable products carefully and follow all the safety
notes and warnings.
1.3 Scope
These instructions for use are valid for the following products:
Product Item number
C-MAC® Video Laryngoscope 8403AX
8403AXC
8403BX
8403BXC
8403HX
8403DXC
8403EXC
8403GXC
8403KXC
8403MXC
8403HXP
8403NXC
Video connecting cable 8403X

General information
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 6
1.4 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 warning messages 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.
NOTICE
ATTENTION
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 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 7
2 Normal use
2.1 Intended use
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 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
tract. 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 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 8
3 Safety
3.1 Serious incidents
According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that
directly or indirectly had, could have had, or could have any of the following consequences
(MDR, 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 must be notified of all serious incidents.
3.2 Correct handling
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 points before and after every use:
– Completeness
– Good working order
– Rough surfaces left inadvertently
– Sharp corners
– Burred edges
– Correct assembly of the components
– Functionality
Do not leave broken-off components inside the patient.
Do not overload the product with mechanical stress.
Do not bend bent products back to their original position.
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 Damaged products
Damaged products can result in injury to patients, users, or third parties.
Before each use, check all components of the product for damage.
Do not use damaged products.

Safety
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 9
3.5 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 joint 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.
3.6 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.26].
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.

Safety
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 10
3.7 Patient leakage current
Patient leakage currents from products may add up if powered endoscopes and powered
endotherapy devices are used simultaneously.
Excessively high leakage current levels may result in the patient becoming injured.
Only use products of the same type together; e.g., CF.
3.8 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.
3.9 Hot components
The high level of light intensity may cause the distal end, the light connections for the
endoscope and fiber optic light cable, and adjacent components to heat up. This can cause
burns to patients, users, or third parties.
The high level of light intensity may cause the distal end of the endoscope to heat up. This can
cause burns to patients, users, or third parties.
Set the light source output to a level that is just high enough to ensure optimal illumination
of the operating area.
Avoid contact with the distal end and light connections of the endoscope and fiber optic
light cable.
Avoid contact with the distal end of the endoscope.
3.10 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 light source output 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 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 11
4 Product description
4.1 Product overview
1
2
Video laryngoscope (8403AXC/BXC/DXC/GXC/KXC/MXC/HXP) without guidance for suction
catheter
1 Socket for video connecting cable 2 Multifunction button
Video laryngoscope (8403EXC) without guidance for suction catheter
Video laryngoscope (8403AX/BX/HX) with guidance for suction catheter
2
1
Video connecting cable (8403X)
1 Laryngoscope connection socket 2 Monitor connection socket

Product description
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 12
4.2 Possible combinations
The C-MAC® Video Laryngoscopes from series 8403 can be operated with the following
monitors:
– C-MAC® Monitor 8403ZX (software version: 704v300 or higher)
– C-MAC® Monitor 8404ZX
– C-MAC® Pocket Monitor 8403XD
– With other monitors via the camera control unit C-HUB® II (20290320) (software version:
721v105 or higher)
The C-MAC® Video Laryngoscopes from series 8403 can be combined with the following
catheters:
– Blade 8403AX with 14Fr. and 16Fr. catheters
– Blade 8403HX and 8403BX with 16Fr. and 18Fr. catheters
4.3 Technical specifications
Video laryngoscope 8403AX/BX/HX/AXC/BXC/KXC/HXP
Designation Value
Immersion protection IPX8
Camera technology CMOS
Resolution 640x480
Illumination: LED, white, 1W
Video laryngoscope 8403AX/BX/HX/AXC/BXC/KXC/HXP serial number 80.000 and higher
Designation Value
Immersion protection IPX8
Camera technology CMOS
Resolution 300x400
Illumination LED, white, 1W
Video laryngoscope 8403DXC/EXC/GXC/MXC/NXC
Designation Value
Immersion protection IPX8
Camera technology CMOS
Resolution 300x400
Illumination LED, white, 1W

Product description
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 13
4.4 Symbols employed
4.4.1 Symbols on the packaging
Symbol Meaning
Number of products in the product packaging
Article no.
CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
Consult instructions for use
Manufacturer
Serial number
Keep dry
Keep away from sunlight
Temperature limit
Date of manufacture
In accordance with US federal law (21 CFR 801.109), this product may
only be sold to or on prescription from a licensed physician.
Not MR safe

Product description
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 14
4.4.2 Symbols on the product
Symbol Meaning
Follow instructions for use
Type BF device
Serial number
CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
4.5 Ambient conditions
Storage/transport conditions
Temperature -20°C...+50°C
Relative humidity
(non-condensing)
5–95%
Operating conditions
Temperature 0°C...40°C
Relative humidity
(non-condensing)
30–70%
Air pressure 700–1,080hPa

Preparation
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_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 evidence of shipping 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
1
Defect pattern: Blade tip bent
Defect pattern: Blade roof bent
3. Check the product for rust and corrosion.

Preparation
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 16
4. Check whether the coating is damaged.
Defect pattern: Poor general condition
5. Ensure that the components and connections are complete, intact, and positioned
correctly.
6. Check whether there are residues and/or moisture at the interfaces.
7. Check the mobility of the components. Instruments that can be dismantled should be
assembled for this purpose.
8. Use a magnifying glass to check that the telescope is complete, intact, and securely
positioned.
Defect pattern: Upper glass missing
Defect pattern: Lower glass broken

Preparation
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 17
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.
2. Make sure that the cable is fully inserted.

Preparation
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 18
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.

Preparation
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 19
5.4 Connecting the C-MAC® Pocket Monitor
The Pocket Monitor can be connected to the product while folded up or down.
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 lugs of the plug connection are opposite each other and the plug is
fully inserted.
ðAs soon as the photo/video recording function is ready, the multifunction button lights
up blue.
ðThe video laryngoscope is ready for operation.
The monitor can be removed and connected to another laryngoscope during use.

Preparation
Instructions for use • C-MAC® Video Laryngoscopes Series 8403 • USB825_EN_V1.1_04-2021_IFU_CE-MDR 20
5.5 Connecting C-Hub® II
1. Connect the video connecting cable to the socket on the product. 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.
5. Connect the monitor to the S-Video output or HDMI output on the rear of the C-HUB® II.