Storz 8404ZX User manual

Instructions for use
C-MAC Monitor
8404ZX
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.
12-2021

Table of contents
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_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 Patient groups ................................................................................................................. 7
2.5 Target user populations................................................................................................... 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 Modifications to the product ........................................................................................... 9
3.6 Opened product .............................................................................................................. 9
3.7 Damage due to ingress of liquid in electrical components ............................................. 9
3.8 Patient leakage current.................................................................................................... 9
3.9 Electromagnetic interference........................................................................................... 9
3.10 National guidelines on airway management.................................................................... 10
4 Product description.................................................................................................................. 11
4.1 Product overview............................................................................................................. 11
4.2 Possible combinations .................................................................................................... 12
4.3 Technical specifications .................................................................................................. 14
4.4 Ambient conditions.......................................................................................................... 16
4.5 Symbols employed .......................................................................................................... 17
4.5.1 Symbols on the packaging ................................................................................. 17
4.5.2 Symbols on the product ..................................................................................... 18
4.5.3 Symbols on the type plate .................................................................................. 19
5 Preparation ............................................................................................................................... 20
5.1 Unpacking the product.................................................................................................... 20
5.2 Assembling the product .................................................................................................. 20
5.3 Connecting the power supply ......................................................................................... 20
5.3.1 Connecting the power supply unit...................................................................... 21
5.3.2 Disconnecting the power supply unit ................................................................. 21
5.3.3 Replacing the power supply unit adaptor........................................................... 21
5.4 Connecting a video unit................................................................................................... 22
5.5 Connecting the external monitor ..................................................................................... 23
6 Application................................................................................................................................ 24
6.1 Switching the product on/off........................................................................................... 24
6.1.1 Switching on the monitor.................................................................................... 24
6.1.2 Switching off the monitor.................................................................................... 25

Table of contents
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 4
6.2 Switching the monitor to standby mode ......................................................................... 25
6.3 Using storage media........................................................................................................ 25
6.3.1 Inserting the SD card .......................................................................................... 25
6.3.2 Inserting the USB stick ....................................................................................... 26
6.4 User interface .................................................................................................................. 26
6.4.1 Start screen layout.............................................................................................. 26
6.4.2 Information area.................................................................................................. 28
6.4.3 Function space ................................................................................................... 28
6.4.4 Password-protected settings ............................................................................. 29
6.4.5 Icons and functions on the user interface .......................................................... 30
6.5 Images and videos .......................................................................................................... 35
6.5.1 Selecting the viewing mode................................................................................ 35
6.5.2 Screen settings ................................................................................................... 37
6.5.3 Capturing stills and recording videos ................................................................. 39
6.5.4 Viewing and deleting captures............................................................................ 40
6.5.5 Performing white balance ................................................................................... 41
6.5.6 Activating the timer............................................................................................. 42
6.6 Copying data from an SD card to a USB stick................................................................ 42
6.7 Setting the date and time ................................................................................................ 43
6.8 Access and security concept .......................................................................................... 43
7 Maintenance, servicing, repairs, and disposal ......................................................................... 45
7.1 Updating the firmware ..................................................................................................... 45
7.2 Replacing the battery ...................................................................................................... 45
7.3 Maintenance .................................................................................................................... 45
7.4 Safety inspection in accordance with IEC 62353............................................................ 45
7.4.1 Visual inspection................................................................................................. 46
7.4.2 Electric measurements ....................................................................................... 46
7.5 Repairing the product...................................................................................................... 46
7.6 Disposing of the product ................................................................................................. 46
8 Accessories and spare parts.................................................................................................... 47
8.1 Accessories ..................................................................................................................... 47
8.2 Spare parts ...................................................................................................................... 47
9 Electromagnetic compatibility .................................................................................................. 48
9.1 General notes on the operating environment .................................................................. 48
9.2 Table 1 – Compliance level for immunity tests................................................................ 48
9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment 49
9.4 Table 3 – Test levels for radiated and conducted immunity tests................................... 50
9.5 Table 4 – Emission class and group................................................................................ 51
9.6 Table 5 – Recommended separation distances between portable and mobile HF
communications equipment and the product ................................................................. 52
10 Errors and messages................................................................................................................ 53
10.1 Fault correction................................................................................................................ 53
11 Subsidiaries .............................................................................................................................. 55

General information
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_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 Monitor 8404ZX
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.
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

General information
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 6
– 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 Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 7
2 Normal use
2.1 Intended use
The monitor for the C-MAC system is used for displaying the visualized anatomy and for
storing and playing back videos and images during an endoscopic procedure. The monitor for
the C-MAC system is designed for transient or short-term use in invasive procedures through a
body orifice or surgically invasive procedures.
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 Patient groups
There are no restrictions in terms of patient groups for this product.
2.5 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.

Safety
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_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
– In the case of several components: completeness and correct assembly
Do not continue to use damaged products.
Dispose of the product properly.
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 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.

Safety
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 9
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.
3.5 Modifications to the product
Modifications to the product reduce the safety of the product. Patients, users, and third parties
may be injured as a result.
Do not modify the product.
3.6 Opened product
If the product is opened, it presents a risk of life-threatening electrical shock.
Do not open the product.
Arrange for service work to be carried out by authorized personnel only.
3.7 Damage due to ingress of liquid in electrical
components
In the case of electrical products, individual components or the product itself may be live.
Liquid ingress into an electrical product may result in a short circuit or an unintentional transfer
of current. The product is damaged as a result and patients, users and third parties may be
injured.
Do not store liquids near the product or on the product.
If liquid has entered the product, pull out the plug and allow the product to dry completely.
3.8 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.
3.9 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 medical electrical 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.48].

Safety
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 10
In case of uncertainties, seek expert advice from KARLSTORZ.
The use of accessories and cables other than those specified in the instructions for use 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.
3.10 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.

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 11
4 Product description
4.1 Product overview
CAUTION
Forceful insertion of sharp objects! Product damage!
If sharp objects are inserted into the microphone opening, the product may be damaged and
leak.
Do not insert any objects into the microphone opening.
12
7
8
9
9
3
5
4
6
C-MAC Monitor 8404ZXK, front
1 8" IPS display 6 Integrated microphone
2 Slot for SD card 7 USB plug
3On/Off button 8 HDMI port
4 Operational readiness LED 9 Connection for video unit
5 Battery charge state LED

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 12
4
123
5
6
7
8
C-MAC Monitor 8404ZXK, back
1 VESA 75 Quick Clip 5 Connection for video unit
2 Holding arm 6 Type plate
3 Power supply connection 7 Data Matrix Code
4 Connection for video unit 8 Serial number
4.2 Possible combinations
The product can be combined with the following components:
Video units for anesthesia
Item Order no.
C-MAC connecting cable 8403X
C-MAC S Imager 8402XS
C-MAC S Imager 8403XS
C-MAC S Imager 8403XSI
C-MAC S Pediatric Imager 8403XSP
C-MAC S Video Laryngoscope MILLER #0 051110-10
C-MAC S Video Laryngoscope MILLER #1 051111-10
C-MAC S Video Laryngoscope MAC #3 051113-10
C-MAC S Video Laryngoscope MAC #4 051114-10
C-MAC S Video Laryngoscope D-BLADE 051116-10
Electronic Module 8402X
C-MAC Video Laryngoscope MAC #3 8401AX
C-MAC Video Laryngoscope MAC #4 8401BX
C-MAC Video Laryngoscope D-BLADE 8401HX
C-MAC Video Laryngoscope MAC #3 8401AXC

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 13
Item Order no.
C-MAC Video Laryngoscope MAC #4 8401BXC
C-MAC Video Laryngoscope MIL #0, alu.
handle
8401DXC
C-MAC Video Laryngoscope MIL #1, alu.
handle
8401GXC
C-MAC Video Laryngoscope D-BLADE Ped. 8401HXP
C-MAC Video Laryngoscope MAC #2 8401KXC
C-MAC Video laryngoscope MAC #3 8403AXC
C-MAC Video laryngoscope MAC #4 8403BXC
C-MAC Video Laryngoscope MIL #0 8403DXC
C-MAC Video laryngoscope MAC #0 8403EXC
C-MAC Video Laryngoscope MIL #1 8403GXC
C-MAC Video laryngoscope D-BLADE, Ped. 8403HXP
C-MAC Video Laryngoscope MAC #2 8403KXC
C-MAC Video Laryngoscope MIL #2 8403MXC
C-MAC Video Laryngoscope MAC #3 8404AX
C-MAC Video Laryngoscope MAC #4 8404BX
C-MAC Video Laryngoscope D-BLADE 8404HX
C-MAC Video Laryngoscope MAC #3 8404AXC
C-MAC Video Laryngoscope MAC #4 8404BXC
C-MAC Video Laryngoscope MIL #0 8404DXC
C-MAC Video Laryngoscope MAC #0 8404EXC
C-MAC Video Laryngoscope MIL #1 8404GXC
C-MAC Video Laryngoscope MAC #2 8404KXC
C-MAC Video Laryngoscope D-BLADE, Ped. 8404HXP
C-MAC Video Laryngoscope MIL #2 8404MXC
C-MAC VS 10331BX
Flex. Intubation Videoscope 11301ABX
Flex. Intubation Videoscope 11301BNX
Flex. Intubation Videoscope 11302BDX
Flex. Intubation Videoscope 11303BNX
Flex. Intubation Videoscope 11304BCX
FIVE S 3.5x65 091361-06
FIVE S 5.3x65 0915612-06

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 14
Video units for ENT
Item Order no.
CMOS Video Rhino-Laryngoscope SSU 091330-06
CMOS Video Esophagoscope SSU 091370-06
CMOS Video Rhino-Laryngoscope 11101CM
CMOS Video Rhino-Laryngoscope 11102CM
CMOS Video Otoscope 121200
Video Esophagoscope 13303E
Video units for urology
Item Order no.
C-View Video Cystoscope 11272V
C-View Video Cystoscope 11272VU
C-View Video Cystoscope 11272VE
C-View Video Cystoscope 11272VUE
Video-uretero-renoscope FLEX-XC1 091271-06
Video-uretero-renoscope FLEX-XC1 091279-06
Video units for imaging
Item Order no.
C-CAM 20290132
E-BOX TP012
H1 Camera head TH130
C-MAC Video Laryngoscope MAC #3 8403AX
C-MAC Video Laryngoscope MAC #4 8403BX
C-MAC Video Laryngoscope MIL #3 8403NXC
4.3 Technical specifications
C-MAC Monitor 8404ZX
Designation Value
Power supply
Degree of protection acc. to
IEC60259*
IP54
Electrical protection class II
Input voltage 12V
Maximum current consumption 2.5A
Battery Lithium-ion, 3.7V, 7,800mAh

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 15
Designation Value
Housing
Dimensions (LxHxW) 231mm x 160mm x 60mm
Weight 1,250g
Screen
Colors Color TFT LCD monitor
Panel IPS
Screen size 8"
Angle of view (diagonal) 89°
Resolution 1,200x1,920pixels
Interfaces
External monitor HDMI
Resolution of 1,920x1,080pixels (Full HD) at a frame rate
of 30fps
Memory device USB
Audio No socket for audio and microphone
*The IP degree of protection can only be ensured if the connection sockets are sealed using
the designated rubber seals.
Charger (ET27-30-0006091)
Designation Value
Power supply 100−240V ~, 50−60Hz, 600–300mA
Output current Max. 2.5A
Output voltage/
power output:
12V / up to 30W
Power connection: Power adaptor for EU/UK/USA/AUS/JP
Degree of protection acc. to
IEC60259
IP40
Cable length 2m
Dimensions of wall power sup-
ply
87mm × 52mm × 33mm (without power adaptor)
Weight Approx. 130g
SD card
Designation Value
Data rate At least 80MB/s
Compatibility Compatible with SDHC SD cards (class10 or higher),
FAT32 formatted, storage capacity up to 32GB

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 16
USB stick
Designation Value
Compatibility Compatible with USB2.0, FAT32 formatted, storage capac-
ity up to 32GB
VESA 75 stand holder (8401YCA)
Designation Value
Diameter 25mm
Open-source software
This product contains free software which falls under the terms of the General Public License
(GPL) and Lesser General Public License (LGPL). The free software used and the correspond-
ing licenses are shown in the License information menu, see chapter Password-protected
settings [p.29]. The source code for this software is available via Technical Support, which
can be contacted via the German KARLSTORZ website (www.karlstorz.com).
4.4 Ambient conditions
Storage/transport conditions
Temperature -10°C...+50°C (14°F...122°F)
Relative humidity
(non-condensing)
5–85%
Air pressure 700–1,080hPa
Operating conditions
Ambient temperature 0°C...40°C (32°F...104°F)
Relative humidity
(non-condensing)
30–70%
Air pressure 700–1,080hPa
Average product life cycle 5years

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 17
4.5 Symbols employed
4.5.1 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Number of products in the product packaging
Unique Device Identifier
Consult the printed or electronic instructions for use
Fragile, handle with care
Keep dry
Temperature limit
Humidity limit

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 18
Symbol Meaning
Air pressure limit
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 directives relevant to the product can be found in the EU Decla-
ration of Conformity, which can be requested from KARLSTORZ.
4.5.2 Symbols on the product
Symbol Meaning
Follow the instructions for use.
The color may differ on the product. The symbol is black/white on the
packaging label.
Power socket
Applied part type BF
Serial number
NRTL certification mark for the USA and Canada
With this mark, the manufacturer declares compliance with the certifica-
tion requirements.

Product description
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 19
4.5.3 Symbols on the type plate
Symbol Meaning
Manufacturer
Separate collection of electrical and electronic devices.
Do not dispose of in household refuse.
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 directives relevant to the product can be found in the EU Decla-
ration of Conformity, which can be requested from KARLSTORZ.
Medical device
Date of manufacture
Data matrix code (example display)
Product information, e.g., UDI

Preparation
Instructions for use • C-MAC Monitor • CFH518_EN_V1.0_12-2021_IFU_CE-MDR 20
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.
4. Keep packaging for further transport.
5.2 Assembling the product
Attaching the monitor to the stand
To attach the monitor to a stand, use VESA75 Quick Clip stand holder 8401YCA and, as an
option, clamp 8401YB, Accessories.
1. Attach the stand holder to the back of the monitor using 4 screws.
2. Press together the holder and slide the holding arm through the holder.
3. Release the holder in the desired position.
ðThe monitor is secured in place on the holding arm.
5.3 Connecting the power supply
The C-MAC Monitor can be powered using either a connected power supply unit or the
integrated lithium-ion battery.
1. Before each use, ensure that the power supply to the monitor for the planned procedure
is provided either by the battery or by a connected power supply unit.
2. If power is supplied by the battery, check the battery charge state on the status bar
(Monitor status bar) and charge the battery if necessary.
Battery charging time and life
The battery can be used for approx. 2hours when fully charged and will last for approx. 4–
5hours on standby mode. The battery life may be shorter depending on the components and
functions used.
Recharge the battery:
– After each use of the device
– Whenever the charge state falls below 50%