Instructions For Use C-MAC Monitor en

en Instructions for use
C-MAC Monitor
8403ZX
02-2021
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.
Table of contents
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............................................................................................................. 5
2 Normal use.................................................................................................................................................... 6
2.1 Intended use ............................................................................................................................................. 6
2.2 Indications for use..................................................................................................................................... 6
2.3 Contraindications...................................................................................................................................... 6
2.4 Target user populations ............................................................................................................................ 6
2.5 Patient groups........................................................................................................................................... 6
3 Safety ............................................................................................................................................................ 7
3.1 Serious incidents ...................................................................................................................................... 7
3.2 Correct handling ....................................................................................................................................... 7
3.3 Unsterile product ...................................................................................................................................... 7
3.4 Damaged products ................................................................................................................................... 7
3.5 Combination with other components ....................................................................................................... 7
3.6 Failure of products .................................................................................................................................... 8
3.7 Modifications to the product..................................................................................................................... 8
3.8 Opened product........................................................................................................................................ 8
3.9 Damage due to ingress of liquid in electrical components....................................................................... 8
3.10 Patient leakage current ............................................................................................................................. 8
3.11 High light intensity .................................................................................................................................... 8
3.12 Electromagnetic interference .................................................................................................................... 8
4 Product description .................................................................................................................................... 10
4.1 Product overview .................................................................................................................................... 10
4.2 Possible combinations............................................................................................................................ 10
4.3 Technical specifications.......................................................................................................................... 12
4.4 Symbols employed ................................................................................................................................. 14
4.4.1 Symbols on the packaging .......................................................................................................... 14
4.4.2 Symbols on the product .............................................................................................................. 15
4.5 Ambient conditions ................................................................................................................................. 16
5 Preparation.................................................................................................................................................. 17
5.1 Unpacking the product ........................................................................................................................... 17
5.2 Assembling the product.......................................................................................................................... 17
5.3 Connecting the power supply................................................................................................................. 17
5.3.1 Connecting the power supply unit............................................................................................... 18
5.3.2 Replacing the charging/power supply unit adaptor .................................................................... 18
5.4 Connecting a video unit .......................................................................................................................... 19
5.4.1 Connecting the primary camera .................................................................................................. 20
5.4.2 Connecting the second camera .................................................................................................. 20
5.5 Connecting the external monitor ............................................................................................................ 20
5.6 Switching on the monitor ........................................................................................................................ 21
5.7 Inserting the SD card .............................................................................................................................. 21
6 Application .................................................................................................................................................. 22
6.1 Basic information on operation............................................................................................................... 22
6.2 Monitor status bar................................................................................................................................... 22
6.3 Control buttons and functions ................................................................................................................ 24
6.4 Transferring data from an SD card to a USB stick ................................................................................. 31
6.5 Messages................................................................................................................................................ 31
Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 3

Table of contents
6.6 Switching the monitor to standby mode................................................................................................. 33

6.7 Switching off the monitor........................................................................................................................ 33
6.8 Performing a reset .................................................................................................................................. 34
7 Maintenance, servicing, repairs, and disposal............................................................................................ 35
7.1 Replacing the battery.............................................................................................................................. 35
7.2 Maintenance ........................................................................................................................................... 35
7.3 Safety inspection in accordance with IEC 62353 ................................................................................... 35
7.3.1 Visual inspection.......................................................................................................................... 35
7.3.2 Electric measurements ................................................................................................................ 35
7.4 Repairing the product ............................................................................................................................. 35
7.5 Disposing of the product ........................................................................................................................ 36
8 Accessories and spare parts ...................................................................................................................... 37
8.1 Accessories............................................................................................................................................. 37
8.2 Spare parts ............................................................................................................................................. 38
9 Electromagnetic compatibility..................................................................................................................... 39
9.1 General notes on the operating environment ......................................................................................... 39
9.2 Table 1 – Compliance level for immunity tests ....................................................................................... 39
9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ....................... 40
9.4 Table 3 – Test levels for radiated and conducted immunity tests .......................................................... 41
9.5 Table 4 – Emission class and group ....................................................................................................... 42
9.6 Table 5 – Recommended separation distances between portable and mobile HF communications
equipment and the product .................................................................................................................... 43
10 Faults and messages .................................................................................................................................. 44
10.1 Troubleshooting ...................................................................................................................................... 44
11 Subsidiaries................................................................................................................................................. 46

General information
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
This instruction manual is valid for:
Product name Article number

C-MAC Monitor 8403ZX
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
2 Normal use
2.1 Intended use
Monitors for the C-MAC® system are used for visualizing anatomy and for storing and playing
back videos and images of an endoscopic procedure. Monitors for the C-MAC® system are
non-invasive and are 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 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.
The product does not come into direct contact with the patient.

Safety
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.
3.5 Combination with other components

Combination of the product with unsuitable instruments and devices can result in uncontrolled
behavior and injury to patients, users, and third parties.
Only combine the device with instruments and equipment that are approved for joint use.

Safety
Observe the instructions for use and interface specifications of the combined devices and
system components.
Only use approved accessories.
3.6 Failure of products

The product may fail during use.
Have a replacement product ready for each application or plan for an alternative surgical
technique.
3.7 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.
3.8 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.
3.9 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.
3.10 Patient leakage current

Patient leakage currents from products may add up if powered products 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, particularly in the case of CF products.
3.11 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.
3.12 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,

Safety
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. 39].
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.

Product description
4 Product description
4.1 Product overview
1 2 3 4 5 6
14
13
7
8
9
10
12 11
1 Connection for CMOS videoendoscope 2 8 On/Off button

(secondary camera)
2 Connection for CMOS videoendoscope 1 9 Charging pilot lamp (orange)
(primary camera)
3 Mains connection: 10 Control buttons
4 Reset button 11 Progress bar
5 SD slot 12 Function symbols
6 Status bar 13 USB port
7 Operating pilot lamp (green) 14 HDMI port
4.2 Possible combinations

The product can be combined with the following components:
Video units for anesthesia
Item Order no.

®
C-CAM 20290132
CMOS Video Otoscope 121200
E-BOX TP010
E-BOX TP012
H1 Camera head TH130
Flex. Intubation Videoscope 11301ABX
Flex. Intubation Videoscope 11301BNX
Flex. Intubation Videoscope 11302BDX
Flex. Intubation Videoscope 11303BNX

Product description
Item Order no.

Flex. Intubation Videoscope 11304BCX
C-MAC® VS 10331BX
Electronic Module 8402X
®
C-MAC Connecting Cable 8403X
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 D-BLADE Ped. 8401HXP
C-MAC® Video Laryngoscope MAC #3 8401AXC
C-MAC® Video Laryngoscope MAC #4 8401BXC
®
C-MAC Video Laryngoscope MIL #0, alu. 8401DXC
handle
C-MAC® Video Laryngoscope MIL #1, alu. 8401GXC
handle
C-MAC® Video Laryngoscope MAC #2 8401KXC
®
C-MAC Video Laryngoscope MAC #3 8403AX
®
C-MAC Video Laryngoscope MAC #3 8403AXC
C-MAC® Video Laryngoscope MAC #4 8403BX
®
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 MAC #2 8403KXC
®
C-MAC Video Laryngoscope MIL #2 8403MXC
®
C-MAC® Video Laryngoscope D-BLADE, Ped. 8403HXP
C-MAC® Video Laryngoscope MAC #3 8404AX
®
C-MAC Video Laryngoscope MAC #3 8404AXC
®
C-MAC Video Laryngoscope MAC #4 8404BX
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 MIL #2 8404MXC
®
®
C-MAC Video Laryngoscope D-BLADE, Ped. 8404HXP

Product description
Item Order no.

C-MAC® S Imager 8402XS
C-MAC® S Imager 8403XS
®
C-MAC S Imager 8403XSI
®
C-MAC S Video Laryngoscope MAC #4 051114-10
C-MAC® S Video Laryngoscope MAC #3 051113-10
C-MAC® S Video Laryngoscope D-BLADE 051116-10
®
C-MAC S Pediatric Imager 8403XSP
®
C-MAC S Video Laryngoscope MILLER #1 051111-10
C-MAC® S Video Laryngoscope MILLER #0 051110-10
Video units for ENT
Item Order no.

CMOS Video Rhino-Laryngoscope 11101CM
CMOS Video Rhino-Laryngoscope 11102CM
Video Esophagoscope 13303E
Video units for urology
Item Order no.

®
C-View Video Cystoscope 11272VU
C-View® Video Cystoscope 11272 V
Storage media
The C-MAC Monitor is compatible with SDHC SD cards of class 4 or higher. If incompatible
memory cards are used, malfunctions may result.
4.3 Technical specifications

Monitor 8403ZX
Dimensions 230 mm x 155 mm x 54 mm
(W x H x D):
Weight: 1250 g
IP degree of protection*: IP54
Protection class: IEC Class II
Input voltage: 12 V
Current consumption: Max. 1.5 A
Battery: Lithium-ion, 3.6 V, 7800 mAh
Resolution: 1280 x 800
Monitor width: 150 mm

Product description
Monitor 8403ZX
Monitor height: 94 mm
Storage medium SD cards, SDHC cards (class 4 or higher)
Video out signal: The connected monitor must support 720p mode.
* Drip water protection can only be ensured if the connection sockets are sealed using the
designated rubber seals.
Charging power supply unit ET27-30-0004695

Power supply: 100−240 V ~, 50−60 Hz
Output current: Max. 1.5 A
Output voltage: 12 V
Mains connection: Power adaptor for EU/UK/USA/AUS/JP
IP degree of protection: IP40
Cable length: 2 m
Dimensions of wall 87 mm × 52 mm × 33 mm (without power adaptor)
power supply:
Weight: Approx. 130 g
SD card
Data rate: 10 MB/s
Compatibility: Compatible with SD and SDHC cards up to 32 GB (class 4 or
higher)
USB stick
Compatibility: USB 2.0-compatible, FAT-formatted, up to 32 GB
VESA 75 stand holder (8401YCA)

Diameter 25 mm
Open Source Software Notice

This product contains free software which falls under the terms of the General Public License
(GPL) and Lesser General Public License (LGPL). To obtain the source code for this software,
contact Technical Support via the German KARL STORZ website (www.karlstorz.com).
Recommended default settings for accessories

Article Brightness Contrast Saturation Hue [%]
[%] [%] [%]
8401AX, 8401AXC, 8401BX, 40 35 40 50
8401BXC, 8401DXC, 8401GXC,
8401HX, 8401HXP, 8401KXC
8402XS 15 45 30 50
8403AX, 8403AXC, 8403BX, 33 25 28 50
8403BXC, 8403HX
8403DXC, 8403EXC, 8403GXC, 47 45 54 50
8403HXP, 8403KXC, 8403MXC

Product description
Recommended default settings for accessories

Article Brightness Contrast Saturation Hue [%]
[%] [%] [%]
8403XS, 8403XSI 50 50 47 50
8403XSP 40 54 53 50
10331BX 52 45 30 50
11102CM 52 45 30 50
11272V, 11272VE, 11272VU, 40 34 25 50
11272VUE
11301ABX 52 45 30 30
11301BNX 40 40 35 50
11302BDX 52 45 30 50
11303BCX 20 5 25 50
11303BNX 52 45 30 50
11304BCX 52 45 30 50
13303E 52 45 30 50
TP010, TP012 52 40 30 50
TH130 50 50 50 50
4.4 Symbols employed

4.4.1 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

Product description
Symbol Meaning
Consult the printed or electronic instructions for use
Fragile, handle with care
Not MR safe
Federal (USA) law restricts this device to sale by or on the order of a

physician.
CE marking
With this mark, the manufacturer declares the compliance of the devices
with the applicable standards and directives
The device must not be modified in any way
4.4.2 Symbols on the product

Symbol Meaning
Type BF device
Power socket
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.
This device has been marked in accordance with the European Directive
on waste electrical and electronic equipment (WEEE).
Manufacturer
Serial number
NRTL certification mark for the USA and Canada

With this mark, the manufacturer declares compliance with the certifica-
tion requirements.

Product description
4.5 Ambient conditions

Operating conditions
Temperature 0 °C ... 40 °C
Charging conditions -10 °C ... +60 °C
(rechargeable battery)
Relative humidity 30 – 70 %
(non-condensing)
Air pressure 700 – 1,080 hPa
Average product life cycle 5 years

Preparation
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.
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,
optionally, clamp 8401YB (see section Accessories [p. 37]).
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.
ð The monitor is secured in place on the holding arm.
5.3 Connecting the power supply

The C-MAC Monitor can be powered using the power supply unit or the integrated lithium-ion
battery.
1. Before use, ensure that the power supply to the monitor for the intended intervention is
provided either by the battery or by a mains connection.
2. If power is supplied by the battery, check the battery charge state on the status bar (see
Monitor status bar [p. 22]) and charge the battery if necessary.
Battery charging and usage time

The battery can be used for approx. 2 hours when fully charged.
Recharge the battery:
– After each use of the device
– Whenever the charge state falls below 50 %
The discharged battery is fully charged after approx. 5 hours when the device is switched off.

Preparation
5.3.1 Connecting the power supply unit

NOTICE
Damage due to incompatible charger
The product may be damaged if an incompatible charger is used.
Only use chargers supplied by KARL STORZ.
1. Insert the connector for the power supply unit into the socket on the monitor.
2. Secure the connector using the swivel nut.

3. Plug the power supply unit into the wall socket, holding onto the plug housing, not the
cable itself.
ð The monitor is connected to the power supply.
ð The green indicator on the power supply unit lights up.
ð The orange status LED lights up.
ð The battery charges.
5.3.2 Replacing the charging/power supply unit adaptor

The charger's power supply unit can be adapted to country-specific power sockets using
interchangeable adaptors.
1. Press the button on the charger power supply unit to change the adaptor.
ð This releases the adaptor, which can then be pushed out.

Preparation
2. Insert the new adaptor into the guide and push it towards the cable until it clicks audibly
into place.
Country-specific configuration
The charger's power supply unit has interchangeable adaptors via which it can adapted to the
power sockets concerned.
Adaptor for EUROPE Adaptor for UK Adaptor for USA/Japan
Adaptor for Australia IEC connection (ROW) Adaptor cable for USA/Japan
5.4 Connecting a video unit

The video unit connecting cable can be inserted or removed while the monitor is in operation.
All video units from KARL STORZ can be attached to both connections, see Possible
combinations [p. 10]. Video units from other manufacturers cannot be connected.
If two video units are connected, select the video unit for which images are to be displayed
from the menu.

Preparation
5.4.1 Connecting the primary camera
Attach the primary camera's connector to the camera connection on the rear of the
product.
5.4.2 Connecting the second camera
Attach the secondary camera's connector to the camera connection on the left housing
side of the product.
5.5 Connecting the external monitor

ü The external monitor supports one of the following resolutions: 1024 x 768 pixels, 1280 x
720 pixels.
ü When a KARL STORZ monitor is connected as an external monitor, the following
adapters are available: HDMI-DVI adapter (20919010).
ü The C-MAC monitor is switched off.
Connect the external monitor to the HDMI port on the C-MAC Monitor.

Preparation
5.6 Switching on the monitor
Press the On/Off button to switch the monitor on.

ð The green operating pilot lamp illuminates.
ð The monitor is switched on.
5.7 Inserting the SD card

ü Before using with the C-MAC monitor, the SD card must be formatted on a PC with FAT
(standard).
ü The SD card has only one partition.
ü The C-MAC monitor is switched off.
1. Insert the SD card into the C-MAC monitor in the correct position.
2. Switch on the C-MAC monitor.

ð The C-MAC monitor’s status bar displays the available memory capacity of the SD card.
NOTICE
Data transmission fault
If the SD card or connecting cable is removed during image/video capture, this can result in
data loss.
Ensure that the SD card and connecting cable are connected to the device during
capture.

Application
6 Application
6.1 Basic information on operation
The screen’s display quality may be affected by bright light (e.g. sunlight).
6.2 Monitor status bar

The following information is displayed in the monitor's status bar:
– Battery charge state
– Free memory capacity on the connected storage media (SD card, USB stick)
– Secondary camera connection
– Progress bar
Symbols on the status bar
Symbol Meaning
Connection of a second camera
Displays the currently active camera (only active if two cameras are connected)
Battery charge state

Battery empty
25%: approx. 30 minutes of operating time
50%: approx. 1 hour of operating time
75%: approx. 1.5 hours of operating time
100%: approx. 2 hours of operating time
Battery is charging

Application
Symbol Meaning
Replace battery: Maximum battery capacity is less than 50% of the original maxi-
mum capacity
SD card storage capacity
100% of memory capacity available
USB stick storage capacity


Application
Symbol Meaning
Progress bar and action currently being carried out

Left: Progress bar shows the progress of the action currently being carried out
Right: Symbol shows the action currently being carried out
Shows the progress of the camera update
Shows the progress of the switch-on procedure
Shows the progress of the reset
Shows the progress of the SD card formatting
Shows the progress of emptying the trash
Shows the progress of the data export to the USB stick
Shows the progress of the white balance
6.3 Control buttons and functions

The monitor is equipped with 4 control buttons. Displayed next to each control button are
changing function symbols. Pressing the control button activates the function currently
displayed.
The video recording and still image storage symbols are visible only if an SD memory card
is inserted.

Application
Certain functions can also be controlled via the camera. The following requirements must be
met:
– The camera has control buttons
– The control buttons on the camera are enabled
The menu consists of levels 1 to 10. Pressing the control button next to the Next level symbol
accesses the functions one level down.
Level 1
Video recording
Starts the video recording and saves the recording to the SD card.
The video recording symbol appears in the top left-hand corner of the live image.
The function symbol next to the control button changes to Stop video recording.
If the video recording symbol is grayed out, video recording is not possible.
Stop video recording
Stops the video recording.
Video recording stops automatically under the following conditions:
– The battery is empty
– The SD card is full
– The device has been switched to standby
– The recording is taking longer than one hour
Still image capture
Saves the live image on the screen to the SD card.
If the Still image capture symbol is not visible or is grayed out, still image cap-
ture is not possible.
Freeze with single image capture
Freezes the live image on the screen and saves the live image to the SD card.
Pressing any control button stops the Freeze function.
Freeze without still image capture
Freezes the live image on the screen.
Pressing any control button stops the Freeze function.
Change camera unit
The Change camera unit symbol is visible only if two camera units are con-
nected to the C-MAC monitor at the same time.
Switches between the two connected camera units.

Application
Level 1
Wrench
Switches to the level 2 functions.
Level 2
Video selection menu
Plays back and/or deletes video recordings saved on the SD card.
Pressing the control button switches to the level 2A functions.
Level 2A Scroll up through list
Scrolls up through the list of saved video recordings.
Scroll down through list

Scrolls down through the list of saved video recordings.
Play
Plays the selected video recording.
Pressing the control button switches to the level 2B functions.
Level 2B Delete
Pressing the control button longer deletes the video
recording. The progress bar in the menu bar shows the
status of the deletion process.
Keep the button pressed until the progress bar in the
menu bar is complete.
ð After deletion, the list of video recordings is shown.
Stop
Stops play back and activates the list of recordings (Video
selection menu).
Pause
Interrupts play back. The Pause symbol changes into the
Play symbol.
Play
Continues play back.
Wrench
Back to level 1.

Application
Level 2
Image selection menu
View recorded images
Views and deletes recorded still images on the SD card.
Pressing the control button switches to the level 2A functions.
Level 2A Scroll up through list
Scrolls up through the list of saved images.
Scroll down through list

Scrolls down through the list of saved images.
Delete
Pressing the button for an extended period deletes the selected im-
age. The progress bar in the menu bar shows the status of the deletion
process.
Keep the button pressed until the progress bar in the menu bar
is complete.
Menu wheel
Activates the functions of the next level. You can move through sev-
eral levels by repeatedly pressing the menu wheel.
Wrench
Back to level 1.
Level 3
White balance
Enables the user to run a manual white balance. The progress bar in the menu bar
shows the status of the deletion process.
Point the tip of the videoendoscope at a white surface and press the control
button.
Keep the button pressed until the progress bar in the menu bar is complete.
Data transfer
Enables the user to carry out a manual data transfer from the SD memory card to
the USB stick. The data transfer may take several minutes.
The Data transfer symbol is deactivated:
– During a data transfer
– If no USB stick is connected
– If the connected USB stick does not have sufficient memory
Menu wheel
Activates the functions of the next level. You can move through several levels by
repeatedly pressing the menu wheel.
Wrench
Back to level 1.

Application
Level 4
Reset
Restores all factory settings.
The camera settings for brightness, contrast, saturation and hue are reset to the
recommended values.
The settings for image rotation, button lock and the Freeze function are reset to
the default settings.
Delete content of SD card
Pressing the control button for an extended period deletes the entire content of
the SD card.
The progress bar in the menu bar shows the status of the deletion process. Dele-
tion may take a few seconds. The Delete content of SD card symbol is deacti-
vated during the deletion process.
Keep the button held down until the progress bar is complete.
Menu wheel
Wrench
Back to level 1.
Level 5
Brightness control
Calls up the +/– function symbols for adjusting the image brightness. The bright-
ness value is shown as a percentage and is saved for this endoscope/camera.
Pressing the menu wheel closes the +/− function symbols level.
Contrast control
Calls up the +/– function symbols for adjusting the contrast. The contrast value is
shown as a percentage and is saved for this endoscope/camera.
Menu wheel
Wrench
Back to level 1.

Application
Level 6
Color saturation
Calls up the +/– function symbols for adjusting the color saturation. The color sat-
uration value is shown as a percentage and is saved for this endoscope/camera.
Hue
Calls up the +/– function symbol for adjusting the hue. The hue is shown as a per-
centage and is saved for this endoscope/camera.
Menu wheel
Wrench
Back to level 1.
Level 7
Date entry
Calls up the +/– function symbols for entering the date in DD/MM/YYYY format.
Enter the day using +/– and confirm by pressing the arrow button.
Enter the month using +/– and confirm by pressing the arrow button.
Enter the year using +/– and confirm by pressing the arrow button.
Pressing the arrow button again closes the +/− function symbols level.
Date entry can be aborted using the Wrench button function symbol.
Time
Calls up the +/– function symbol for entering the time.
Enter the hours using +/– and confirm by pressing the arrow button.
Enter the minutes using +/– and confirm by pressing the arrow button.
Pressing the arrow button again closes the +/− function symbols level.
Menu wheel
Wrench
Back to level 1.
Level 8
Version information
Displays the version number of the firmware version installed on the monitor, as
well as the article number and the version number of the connected videoendo-
scope. If a videoendoscope is not connected, N.C. (not connected) appears.
Software update

Application
Level 8
If an SD card with new software is inserted, the software update can be initiated
using this function. If no software is available on the SD card, the symbol is
grayed out.
A software update may only be performed by an authorized KARL STORZ em-
ployee.
Before starting the software update, ensure that the battery is charged or
that the C-MAC Monitor is connected to the mains. A CMOS
videoendoscope does not have to be connected to the monitor.
A software update automatically causes the product to restart.
Menu wheel
Wrench
Back to level 1.
Level 9
Rotate image
Rotates the image on the screen by 180°. The setting is saved for this endoscope/
camera.
This function is only activated if the endoscope/camera connected supports this
function.
Activate button lock
Locks the buttons on the camera. The function symbol next to the control button
changes (locks open).
Pressing again unlocks the buttons. The setting is saved for this endoscope/cam-
era.
Not all endoscopes/cameras support this functionality.
Menu wheel
Wrench
Back to level 1.

Application
Level 10
Toggle Freeze/Still image capture
Toggles between Freeze with still image capture and Still image capture.
Freeze with still image capture freezes the live image on the screen and saves
the image to the SD card.
Still image capture saves the live image on the screen to the SD card.
The setting is saved for this endoscope/camera.
This function is only activated if the endoscope/camera connected supports this
function.
Menu wheel
Wrench
Back to level 1.
6.4 Transferring data from an SD card to a USB stick

The USB port serves exclusively to transfer data from the SD card to the USB stick. Data
cannot be saved directly to a connected USB stick.
ü Before use with the C-MAC monitor, the USB stick must be formatted on the PC with
FAT (standard) and has only one partition.
Connect the USB stick to the C-MAC monitor.
ð The video data are being transferred from the SD card to the USB stick.
When data are transferred from an SD card to a USB stick, the data are copied from the SD
card and not deleted. The data on the SD card can only be deleted manually on the C-MAC
monitor.
In the case of large video files or multiple recordings, the data transfer can take a long time.
A USB stick with a large storage capacity can delay the storage of images.
6.5 Messages
Messages indicating a critical status are shown on the monitor in two different ways.
Status message
– The corresponding symbol in the top status bar has a white background.
Warning message

Application
– The symbol indicating a critical situation appears in the bottom right-hand corner of the
monitor
Status messages
Battery charge state
SD card capacity
USB stick capacity
Warning messages
Critical battery charge state

The battery charge state has reached a critical level.
Connect the monitor to the power supply.
SD card full
The SD card is full or write-protected and will not allow any more data to be saved.
Remove the write protection or change the SD card
No data can be saved to the USB stick
The USB stick does not allow data transfer from the SD card.
Possible causes:
– Not enough memory capacity on the USB stick
– USB stick is write protected
– USB stick is damaged
The status message in the status bar continues to be shown until the cause of the message is
resolved.
Up to 3 status messages can appear simultaneously, these are acknowledged in succession.

Application
Acknowledging warning message

Press the control button next to the warning message.
ð The symbol for the critical situation disappears. The Wrench symbol appears.
6.6 Switching the monitor to standby mode

Standby mode enables the monitor to be quickly ready for operation again in the event of brief
interruptions.
Press the On/Off button briefly.
ð The green status LED flashes.
ð The monitor switches to standby mode. After 5 minutes in standby mode, the monitor
switches off.
The monitor switches to standby mode after 20 minutes of inactivity.
6.7 Switching off the monitor
Pressing the On/Off button longer turns the monitor off.

Keep the On/Off button pressed until the progress bar is complete.
ð The green operating pilot lamp extinguishes.

Application
ð The monitor is switched off.
6.8 Performing a reset

If the device stops responding although connections and power supply are in order, a system
error has occurred and a system reset must be carried out.
The reset switch is located in a recess to protect it from unintentional activation.
1. Insert a ballpoint pen or similar into the reset switch next to the SD slot and carefully
push downwards.
Or
Keep the On/Off button pressed for at least 10 seconds.
ð The system is being reset.
2. Switch on the device again with the On/Off button.

Maintenance, servicing, repairs, and disposal
7 Maintenance, servicing, repairs, and disposal

7.1 Replacing the battery
The battery’s capacity decreases over time. KARL STORZ recommends replacing the battery
after 2 years.
The battery may only be replaced by persons authorized by KARL STORZ.
7.2 Maintenance
Maintenance work may only be carried out by KARL STORZ or a company authorized by
KARL STORZ.
Interval Maintenance work To be performed by

annually Safety inspection KARL STORZ Service techni-
cians
7.3 Safety inspection in accordance with IEC 62353

WARNING
Risk of injury due to product deficiencies!
Patients, users, and third parties may be injured as a result of deficiencies with the product and
accessories.
Shut down the product.
Have the deficiencies repaired by persons authorized by KARL STORZ.
Regardless of the national accident prevention regulations and testing intervals for medical
devices, for this device safety checks must be performed as repeat inspections according to
IEC 62353 and recorded by a qualified electrician at least once a year. Detailed specifications
regarding the scope and execution of the safety inspection can be found in the service manual.
7.3.1 Visual inspection

1. Check the product and accessories for any mechanical damage.
2. Check labels for readability.
7.3.2 Electric measurements

Limit values for electrical measurements can be found in the current IEC 62353.
1. Measure the protective ground resistance.

2. Measure the earth leakage current.
3. Measure the touch current.
4. Measure the patient leakage current.
7.4 Repairing the product

Repair work may only be performed by KARL STORZ or by a company authorized by
KARL STORZ. The interventions described in this instruction manual are exempt from this rule.
Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of
subsidiaries).

Maintenance, servicing, repairs, and disposal
Contaminated devices may not be shipped. To prevent contact infections and airborne
infections, products must first be decontaminated. KARL STORZ reserves the right to send
back contaminated products.
7.5 Disposing of the product

The product meets the requirements of the Directive on Waste Electrical and Electronic
Equipment (WEEE).
Within the scope of application of this directive, KARL STORZ SE & Co. KG is responsible for
the proper disposal of this product.
1. The product must be disposed of in accordance with the applicable national laws and
regulations at a suitable collection point for the reprocessing of electrical and electronic
equipment.
2. Contact KARL STORZ SE & Co. KG, a KARL STORZ branch or an authorized dealer to
find out the address of the collection point in your area.

Accessories and spare parts
8 Accessories and spare parts

8.1 Accessories
Item Order no.
®
Stand, for C-MAC Monitor, height 120 cm, 8401YA
five-feet roller stand with antistatic castors,
crossbar 25 cm x Ø 25 mm, for positioning
the monitor, with storage basket for laryngo-
scopes, dimensions (W x D x H):
30 x 20 x 10 cm
Crossbar, for stand 8401YA, 8401YAA
50 cm x Ø 25 mm, for positioning C-MAC®
Monitor 8401ZX / 8402ZX / 8403ZX
Crossbar, for stand 8401YA, 8401YAB
70 cm x Ø 25 mm, for positioning C-MAC®
Monitor 8401ZX / 8402ZX / 8403ZX
Clamp, VESA 75 standard, for fixation of C- 8401YB
MAC® Monitor to round profile with diameter
20–43 mm and square profile with diameter
16–27 mm, for use with monitors 8401ZX /
8402ZX / 8403ZX
Protective bag, blue, for C-MAC® system, 8403YD
made from water-resistant and hard-wearing
material, washable, separate compartments
for monitor and three C-MAC® Video Laryn-
goscopes with electronic module for use with
C-MAC® Monitor 8401ZX / 8402ZX / 8403ZX,
electronic module 8401X / 8402X, power sup-
ply unit, 3 x C-MAC® Video Laryngoscopes
Airway TROLL-E monitor cart, on 4 antistatic 20020085
double castors, 2 of which are lockable, with
VESA 75/100 holder for mounting a monitor,
integrated cable conduit in central upright,
load capacity of monitor module max. 15 kg,
dimensions of monitor cart:
670 x 1,660 x 670 mm (W x H x D), castor di-
ameter: 100 mm. Cart is not delivered assem-
bled.
C-MAC® TROLL-E, on 4 antistatic double 20020086
castors, 2 of which are lockable, with stain-
less steel tube, dimensions of monitor cart:
670 x 1,500 x 670 mm (W x H x D), castor di-
ameter: 100 mm. Cart is not delivered assem-
bled.

Accessories and spare parts
8.2 Spare parts

Article Order no.
Power supply unit, for C-MAC® Monitor ET27-30-0004695
8403ZX
VESA 75 Quick Clip, with 4 clamping screws, 8401YCA
for mounting C-MAC® to holding arms up to
diameter 25 mm
Exchangeable adaptors for charger
Article Order no.

Adaptor for EUROPE ET27-30-0004697
Adaptor for UK ET27-30-0004698
Adaptor for USA/Japan ET27-30-0004699
Adaptor for Australia ET27-30-0004700
IEC connection (ROW) ET27-30-0004701
Adaptor cable for USA/Japan ET27-30-0004370

Electromagnetic compatibility
9 Electromagnetic compatibility
9.1 General notes on the operating environment
The product is suitable for use in professional healthcare settings. Professional healthcare
facilities include physician offices, dental offices, limited care facilities, freestanding surgical
centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms,
patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system
for MRT).
The emission characteristics of this product make it suitable for use in professional
healthcare facilities as well as in a residential environment (CISPR 11 Class B). This
product offers adequate protection to radio communication service. In the rare event of
interference to the radio transmission operation, the user might need to take mitigation
measures, such as relocating or re-orienting the product.
9.2 Table 1 – Compliance level for immunity tests

Guidelines and manufacturer’s declaration – electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user
of the product should make sure that it is used in such an environment.
Interference im- EN/IEC 60601 test Compliance level Electromagnetic envi-

munity tests level ronment – guidelines
Electrostatic dis- ± 8 kV contact dis- ± 8 kV contact dis- Floors should be made
charge (ESD) acc. charge charge of wood, concrete, or
to IEC 61000-4-2 ± 15 kV air discharge ± 15 kV air discharge covered with ceramic
tiles. If floors are cov-
ered with synthetic ma-
terial, the relative hu-
midity must be at least
30%.
Electrical fast ± 2 kV for power lines ± 2 kV for power lines The power supply qual-
transients/bursts ± 1 kV for input and ± 1 kV for input and ity should be that of a
acc. to IEC output lines output lines typical commercial or
61000-4-4 hospital environment.
100 kHz repetition 100 kHz repetition
Surges acc. to ± 1 kV voltage outer ± 1 kV voltage outer The power supply qual-
IEC 61000-4-5 conductor – outer con- conductor – outer con- ity should be that of a
ductor ductor typical commercial or
± 2 kV voltage outer ± 2 kV voltage outer hospital environment.
conductor – ground conductor – ground
Voltage dips, Voltage dip: Voltage dip: The power supply qual-
short interrup- Dip to 0% for 1 cycle Dip to 0% for 1 cycle ity should be that of a
tions, and voltage at 0° phase angle at 0° phase angle typical commercial or
variations acc. to hospital environment. If
IEC 61000-4-11 Dip to 70% for 25/30 Dip to 70% for 25/30 the user of the product
cycles at 0° phase an- cycles at 0° phase an- requires continued op-
gle gle eration in the event of
Dropout to 0% for 0.5 Dropout to 0% for 0.5 interruptions to the
cycles @ 0°, 45°, 90°, cycles @ 0°, 45°, 90°, power supply network,
135°, 180°, 225°, 270°, 135°, 180°, 225°, 270°, it is recommended that
and 315° phase angles and 315° phase angles the product be oper-
Voltage interruption: Voltage interruption:

Interference im- EN/IEC 60601 test Compliance level Electromagnetic envi-

munity tests level ronment – guidelines
100% for 250/300 cy- 100% for 250/300 cy- ated with an uninter-
cles cles ruptible power supply
or a battery.
Magnetic field at 30 A/m at 50 Hz / 30 A/m at 50 Hz / If image distortion oc-
the power fre- 60 Hz 60 Hz curs, it may be neces-
quency (50/60 Hz) sary to install the prod-
acc. to IEC uct further from sources
61000-4-8 of electromagnetic
fields or to install mag-
netic shielding. Before
the product is installed,
the electromagnetic
field should be mea-
sured to ensure that it
is sufficiently low.
Immunity test acc. 3 V/m 80 MHz to 3 V/m 80 MHz to
to IEC 61000-4–3 2.7 GHz 2.7 GHz
for radiated, ra- * Refer to Table 2 for
dio-frequency wireless proximity RF
electromagnetic field test levels
fields
Immunity to con- 3 Vrms on 150 kHz to 3 Vrms on 150 kHz to
ducted distur- 80 MHz 80 MHz
bances, induced 1 kHz 80% AM modu- 1 kHz 80% AM modu-
by radio-fre- lation lation
quency fields acc.
to IEC 61000-4-6 6 Vrms in ISM band 6 Vrms in ISM band
9.3 Table 2 – Test levels for proximity fields from HF

wireless communications equipment
Test fre- Frequency Radio service Modulation Immunity Compliance
quency band test level level
MHz MHz V/m V/m
385 380 – 390 TETRA 400 Pulse modula- 27 27
tion 18 Hz
450 430 – 470 GMRS 460, FM ± 5 kHz 28 28
FRS 460 deviation
1 kHz sine
wave
710 704 – 787 LTE band 13 & Pulse modula- 9 9
17 tion
745
217 Hz
780
810 800 – 960 GSM 800/900, Pulse modula- 28 28
TETRA 800, tion
870
iDEN 820, 18 Hz
930 CDMA 850,
LTE band 5

Test fre- Frequency Radio service Modulation Immunity Compliance

quency band test level level
MHz MHz V/m V/m
1,720 1,700 – 1,990 GSM 1800, Pulse modula- 28 28
CDMA 1900, tion
1,845
GSM 1900, 217 Hz
1,970 DECT,
LTE band 1, 3,
4, 25,
UMTS
2,450 2,400 – 2,570 Bluetooth, Pulse modula- 28 28
WLAN 802.11 tion
b/g/n, 217 Hz
RFID 2450,
LTE band 7
5,240 5,100 – 5,800 WLAN 802.11 Pulse modula- 9 9
a/n tion
5,500
217 Hz
5,785
9.4 Table 3 – Test levels for radiated and conducted

immunity tests
Guidelines and manufacturer’s declaration – electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user
of the product should make sure that it is used in such an environment.
Interference immunity EN/IEC 60601 test Compliance Electromagnetic envi-

tests level level ronment – guidelines
Conducted HF distur- 3 Vrms 3 Vrms Portable and mobile HF
bances acc. to IEC 150 kHz to 80 MHz communications equip-
61000-4-6 ment should be used no
closer to any part of the
Radiated HF distur- 3 V/m 3 V/m
product, including cables,
bances acc. to IEC 80 MHz to 2.5 GHz than the recommended
61000-4-3
separation distance calcu-
lated from the equation
applicable to the fre-
quency of the transmitter.
Recommended separation
distances:
d = 1.2 √P
Where P is the rated
power of the transmitter in
watts [W] according to the
information provided by
the transmitter manufac-
turer and d is the recom-
mended separation dis-
tance in meters [m].

Interference immunity EN/IEC 60601 test Compliance Electromagnetic envi-

tests level level ronment – guidelines
Field strengths from fixed
HF transmitters as deter-
mined by an electromag-
netic site survey a should
be less than the compli-
ance level in each fre-
quency range b.
d = 1.2 √P
80 MHz to 800 MHz
d = 2.3 √P
800 MHz to 2.5 GHz
Interferences may occur in
the vicinity of equipment
marked with the following
symbol:
Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. The propagation of electromagnetic
waves is affected by absorptions and reflections of buildings, objects, and people.
a
Field strengths from fixed transmitters, e.g., base stations for radio (cellular/cordless) tele-
phones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broad-
cast cannot be predicted theoretically with accuracy. To assess the electromagnetic environ-
ment due to fixed transmitters, an electromagnetic site survey should be considered. If the
measured field strength at the location where the device is used exceeds the above compli-
ance levels, the device should be monitored to ensure proper function. If abnormal perfor-
mance is observed, additional measures may be necessary, such as re-orienting or relocating
the product.
b
Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/
m.
9.5 Table 4 – Emission class and group

Guidelines and manufacturer’s declaration – Electromagnetic emissions
The product is intended for use in such an environment as specified below. The customer or
user of the product should ensure that it is used in such an environment.
Emission measurements Compliance Electromagnetic environment –

Guidelines
RF emissions as per CISPR 11 Group 1 The product uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions as per CISPR 11 Class B The product is suitable for use in all
establishments including domestic
Harmonic emissions as per IEC N/A
establishments and those directly
61000-3-2
connected to the public low voltage

Emission measurements Compliance Electromagnetic environment –

Guidelines
Voltage fluctuations/flicker emis- complies power supply network that supplies
sions as per IEC 61000-3-3 buildings used for domestic pur-
poses.
9.6 Table 5 – Recommended separation distances between

portable and mobile HF communications equipment
and the product
The product is intended for use in an electromagnetic environment in which HF disturbances
are controlled. The customer or user of the product can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile HF
communications equipment (transmitters) and the product as recommended below, according
to the output energy of the communications equipment.
Rated power of the Separation distance d [m] according to the transmitter frequency
transmitter [W]
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P d = 1.2 √P d = 2.3 √P
0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters whose maximum rated power is not listed in the table above, the recom-
mended separation distance d in meters (m) can be estimated using the equation from the re-
spective column, whereby P is the maximum rated power of the transmitter in watts (W) ac-
cording to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range ap-
plies.
Note: These guidelines may not apply in all situations. The propagation of electromagnetic
waves is affected by absorptions and reflections of buildings, objects, and people.

Faults and messages
10 Faults and messages

10.1 Troubleshooting
Error description Possible causes Remedy
Complete failure of the device – Power supply failure – Check the power
Status display may be lit – Loose connection supply.
between power supply – Push the power supply
plug and socket on plug firmly into the
device socket on the device.
– System error – Reset.
No picture, screen dark – Videoendoscope not – Push in the
fully inserted videoendoscope as far
– Defective camera as it will go.
electronics – Send the
– Screen defective videoendoscope or
supply unit to
KARL STORZ for repair.
Cloudy image, stripes, – Videoendoscope – Clean the
streaks, or similar telescope is soiled videoendoscope
– Videoendoscope telescope with a cotton
contacts are soiled swab and alcohol
solution or special
cleaning paste.
– Clean videoendoscope
contacts.
Color distortions – White balance not – Carry out new white
carried out correctly balance.
– Screen or – Send the supply unit for
videoendoscope repairs to KARL STORZ.
defective
Color rendering alternates – Camera connecting – Have a new camera
cable defective connecting cable fitted.
Image cannot be saved. – No memory card – Insert a memory card.
The icon is not displayed on inserted – Change the memory
the menu bar – Memory card full card.
– Memory card is not – Insert the memory card
recognized while the C-MAC®
monitor is switched off
and then turn the
monitor on again.
– Reset the system to
ensure that the SD card
is recognized.
– Format the memory
card on the PC with FAT
(standard).

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

played back on the PC moni- installed codec on the PC.
tor
Unable to write to the SD – SD card is formatted – Format the SD card on
card incorrectly the PC with FAT
– SD card is write- (standard).
protected – The SD card must have
only one partition.
– Remove the write
protection on the SD
card.
Unable to write to the USB – USB stick is formatted – Format the USB stick
stick incorrectly on the PC with FAT
(standard).
– The USB stick must
have only one partition.
– Remove the write
protection from the USB
stick.

Subsidiaries
11 Subsidiaries
KARL STORZ SE & Co. KG KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Representation Office
Postfach 230, 78503 Tuttlingen/Germany Kęstučio st. 59 / Lenktoji st. 27, 08124 Vilnius, Lithuania
Phone: +49 7461 708-0 , Fax: +49 7461 708-105 Phone: +370 5 272 0448, Mobile: +370 685 67 000
Email: [email protected] Email: [email protected]
KARL STORZ Endoskope Berlin GmbH KARL STORZ Endoskopi Danmark A/S
Scharnhorststr. 3, 10115 Berlin/Germany Skovlytoften 33, 2840 Holte, Denmark
Phone: +49 30 3069090, Fax: +49 30 30 19452 Phone: +45 45162600, Fax: +45 45162609
Email: [email protected]
KARL STORZ Endoscopy Canada Ltd.
7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada KARL STORZ Endoscopy (UK) Ltd.
Phone: +1 905 816-4500, Fax: +1 905 816-4599 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom
Toll free (Canada only) Phone: 1-800-268-4880, Fax: 1-800-482-4198 Phone: +44 1753 503500, Fax: +44 1753 578124
(Canada only) Email: [email protected]
KARL STORZ Endoscopie Nederland B. V.
KARL STORZ Endoscopy-America, Inc. Displayweg 2, 3821 BT Amersfoort, Netherlands
2151 East Grand Avenue, El Segundo, CA 90245-5017, USA Phone: +31 (0)33 4545890
Phone: +1 424 218-8100, Fax: +1 424 218-8525 Email: [email protected]
Toll free (USA only) Phone: 800 421-0837, Fax: 800 321-1304 (USA only)
Email: [email protected] KARL STORZ Endoscopy Belgium N. V.
Phone: +31 (0)33 4545890
KARL STORZ Veterinary Endoscopy-America, Inc. Email: [email protected]
1 South Los Carneros Road, Goleta, CA 93117, USA
Phone: +1 805 968-7776, Fax: +1 805 685-2588 KARL STORZ Endoscopie France S. A. S.
Email: [email protected] 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France
Phone: +33 1 30484200, Fax: +33 1 30484201
KARL STORZ Endoscopia Latino-America, Inc. Email: [email protected]
815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA
Phone: +1 305 262-8980, Fax: +1 305 262-8986 KARL STORZ Endoskop Austria GmbH
Email: [email protected] Landstraßer Hauptstr. 148/1/G1, 1030 Wien, Austria
Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479
KARL STORZ Endoscopia México S.A. de C.V. Email: [email protected]
Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna,
Cuba KARL STORZ Endoscopia Ibérica S. A.
Phone: +537 836 95 06, Fax: +537 836 97 76 Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830
Email: [email protected] Madrid, Spain
Phone: +34 91 6771051, Fax: +34 91 6772981
KARL STORZ Endoscopia México S.A. de C.V. Email: [email protected]
Av. Ejercito Nacional No. 453 Piso 2, Colonia Granada, Alcaldia Miguel
Hidalgo, C.P. 11520 Ciudad de México KARL STORZ Endoscopia Italia S. r. l.
Phone: +52 (55) 1101 1520 Via dell’Artigianato, 3, 37135 Verona, Italy
Email: [email protected] Phone: +39 045 8222000, Fax: +39 045 8222001
KARL STORZ Marketing América Do Sul Ltda.
Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São KARL STORZ Croatia d.o.o.
Paulo, Brasil Capraška 6, 10000 Zagreb, Croatia
Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 Phone: +385 1 6406 070, Fax: +385 1 6406 077
KARL STORZ Endoscopia Argentina S.A. KARL STORZ Endoskopija d.o.o.

Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de Buenos Cesta v Gorice 34b, 1000 Ljubljana, Slovenia
Aires, Argentina Phone: +386 1 620 5880, Fax: + 386 1 620 5882
Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 Email: [email protected]
Email: [email protected] KARL STORZ Polska Sp. z o.o.
KARL STORZ Endoskopi Norge AS ul. Bojkowska 47, 44-100 Gliwice, Poland
Stamveien1, 1483 Hagan, Norway Phone: +48 32 706 13 00, Fax: +48 32 706 13 07
Phone: +47 6380 5600, Fax: +47 6380 5601 Email: [email protected]
Email: [email protected] KARL STORZ Endoszkóp Magyarország Kft.
KARL STORZ Endoskop Sverige AB Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary
Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +36 195 096 31, Fax: +36 195 096 31
Phone: +46 8 505 648 00 Email: [email protected]
Email: [email protected] KARL STORZ Endoscopia Romania srl
KARL STORZ Endoscopy Suomi OY Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bukarest, Romania
Taivaltie 5, 01610 Vantaa, Finland Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801
Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: [email protected]
Email: [email protected] KARL STORZ Endoskope Greece M.E.P.E.*
Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece
Phone: +30 2310 304868, Fax: +30 2310 304862
*Repair & Service Subsidiary

Subsidiaries
KARL STORZ Industrial** KARL STORZ Endoscopy (Shanghai) Ltd., Chengdu Branch
Gedik Is Merkezi B Blok, Kat 5, D 38-39, Bagdat Cad. No: 162, Maltepe Room 803-805, 8F Jin Jiang International Building, No. 1 West Linjiang
Istanbul, Turkey Road, Wuhou District, 6100414, Chengdu, People’s Republic of China
Phone: +90 216 442 9500, Fax: +90 216 442 9030 Phone: +86 28 86587977, Fax: +86 28 86587975
**Sales for Industrial Endoscopy Email: [email protected]
OOO KARL STORZ Endoskopy – WOSTOK KARL STORZ Endoscopy (Shanghai) Ltd., Shenyang Branch
Derbenyevskaya nab. 7, building 4, 115114 Moscow, Russia Room 2001-2005, 20F N-MEDIA International Center, No. 167 Youth Avenue,
Phone: +7 495 983 02 40, Fax: +7 495 983 02 41 Shenhe District, 110014, Shenyang, People‘s Republic of China
Email: [email protected] Phone: +86 24 23181118, Fax: +86 24 23181119
TOV LLC KARL STORZ Ukraine
Avenue Geroyiv Stalingrada Str. 2D, office 717 Kyiv, 04210/Ukraine KARL STORZ Endoscopy (Shanghai) Ltd., Guangzhou Branch
Phone: +38 095 000-895-0, +38-097-000-895-0, +38 073 000-895-0 Room 02B & 03 & 04A, 35F Teem Tower, No. 208 Tianhe Road, Tianhe
Email: [email protected] District, 510620, Guangzhou, People’s Republic of China
Phone: +86 20 87321281, Fax: +86 20 87321286
KARL STORZ SE & Co. KG Representation Office Email: [email protected]
Sabit Orudschow 1184, apt. 23, 1025 Baku, Azerbaijan
Phone: +99 450 613 30 60 KARL STORZ Endoscopy Asia Marketing Pte Ltd.
Email: [email protected] No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
Phone: +65 69229150, Fax: +65 69229155
KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. Email: [email protected]
Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,
Lebanon KARL STORZ Endoscopy Singapore Sales Pte Ltd
Phone: +961 1 501105, Fax: +961 1 501950 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore
Email: [email protected] Phone: +65 69229150, Fax: +65 69229155
KARL STORZ Endoscopy (South Africa) (Pty) Ltd.
P.O. 6061, Roggebaai, 8012 Cape Town, South Africa KARL STORZ SE & Co. KG Representative Office Indonesia
Phone: +27 21 417 2600, Fax: +27 21 421 5103 Sinarmas MSIG Tower Level 37, Jl. Jend. Surdirman No. Kav. 21, Jakarta
Email: [email protected] Selatan
DKI Jakarta 12920
TOO KARL STORZ Endoskopy Kasachstan Email: [email protected]
Saryarka, 6, BC “Arman“, off. 910, 010000 Astana, Republic of Kazakhstan
Phone: +7 7172 552-549, 552-788, Fax: -444 KARL STORZ Endoscopy Korea Co. Ltd.
Email: [email protected] 9F Hyowon-Building, 97, Jungdae-ro, Songpa-gu, 05719 Seoul, Korea
Phone: +82-70-4350-7474, Fax: +82-70-8277-3299
KARL STORZ ENDOSKOPE East Mediterranean & Gulf (branch) Email: [email protected]
Building West Side 7A – Unit 7WA – 3008, Dubai Airport Free Zone, P.O. Box
54983, Dubai - United Arab Emirates KARL STORZ Endoscopy Taiwan Ltd.
Phone: +971 (0)4 2958887, Fax: +971 (0)4 3205282 12F, No. 192, Sec. 2, Chung Hsin Rd., Sindian District, New Taipei City,
Service Hotline: +971 (0)4 3415882 Taiwan
Email: [email protected] Phone: +886 933 014 160, Fax: +886 2 8672 6399
KARL STORZ Endoscopy India Private Limited
11th Floor, Dr. Gopal Das Bhawan, 28, Barakhamba Road, New Delhi KARL STORZ SE & Co. KG Representative Office Philippines
110001, India 1901 Picadilly Star Bldg., 4th Avenue, BGC, Taguig City 1636, Philippines
Phone: +91 11 4374 3000, Fax: +91 11 4374 3010 Phone: +63 2 317 45 00, Fax: +63 2 317 45 11
KARL STORZ SE & CO. KG KARL STORZ Endoscopy Japan K. K.

Interchange 21 Tower, Level 33, 399 Sukhumvit Road, North Klongtoey, Stage Bldg. 8F, 2-7-2 Fujimi, Chiyoda-ku, Tokyo 102-0071, Japan
Wattana, 10110 Bangkok, Thailand Phone: +81 3 6380-8622, Fax: +81 3 6380-8633
Phone: +84 28 3823 8000 Fax: +84 28 3823 8039 Email: [email protected]
KARL STORZ Endoscopy Australia Pty. Ltd .
KARL STORZ SE & Co. KG 68 Waterloo Road, Macquarie Park NSW 2113, P O Box 50 Lane Cove NSW
Resident Representative Office 1595, Australia
14th Floor, MPlaza Saigon, 39 Le Duan, District 1, Ho Chi Minh City, Vietnam Phone: +61 (0)2 9490 6700, Fax: +61 (0)2 9420 0695
Phone: +84 28 3823 8000, Fax: +84 28 3823 8039 Toll free: 1800 996 562 (Australia only)
KARL STORZ Endoscopy China Ltd. www.karlstorz.com

Room 2503-05, 25F AXA Tower, Landmark East, No. 100 How Ming Street,
Kwun Tong, Kowloon, Hong Kong, People’s Republic of China
Phone: +852 28 65 2411, Fax: +852 28 65 4114
KARL STORZ Endoscopy (Shanghai) Ltd., Beijing Branch

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

Room 701A Building 5 & Room 501 Building 7, No. 3000 Longdong Avenue,
Pilot Free Trade Zone, 201203, Shanghai, People’s Republic of China
Phone: +86 21 60339888, Fax: +86 21 60339808

NDQ566 • EN • V1.0 • 02-2021 • IFU • CE-MDR
KARL STORZ SE & Co. KG

Dr.-Karl-Storz-Straße 34
78532 Tuttlingen
Postfach 230
78503 Tuttlingen
Germany
Phone: +49 7461 708-0

Fax: +49 7461 708-105
E-mail: [email protected]
www.karlstorz.com

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en Instructions for use

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 3

6.6 Switching the monitor to standby mode................................................................................................. 33

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 4

1.2 Read the instructions for use of combinable products

Product name Article number

1.4 Description of warning messages

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 5

2.2 Indications for use

2.4 Target user populations

2.5 Patient groups

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 6

3.2 Correct handling

3.3 Unsterile product

3.4 Damaged products

3.5 Combination with other components

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 7

3.6 Failure of products

3.7 Modifications to the product

3.8 Opened product

3.9 Damage due to ingress of liquid in electrical

3.10 Patient leakage current

3.11 High light intensity

3.12 Electromagnetic interference

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 8

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 9

1 Connection for CMOS videoendoscope 2 8 On/Off button

4.2 Possible combinations

Video units for anesthesia

Item Order no.

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 10

Item Order no.

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 11

Item Order no.

Video units for ENT

Item Order no.

Video units for urology

Item Order no.

4.3 Technical specifications

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 12

Charging power supply unit ET27-30-0004695

VESA 75 stand holder (8401YCA)

Open Source Software Notice

Recommended default settings for accessories

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 13

Recommended default settings for accessories

4.4 Symbols employed

Number of products in the product packaging

Unique Device Identifier

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 14

Fragile, handle with care

Federal (USA) law restricts this device to sale by or on the order of a

4.4.2 Symbols on the product

NRTL certification mark for the USA and Canada

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 15

4.5 Ambient conditions

Instructions for use • C-MAC Monitor • NDQ566_EN_V1.0_02-2021_IFU_CE-MDR 16

5.2 Assembling the product

5.3 Connecting the power supply