Storz C-MAC S User manual

Instructions for use
C-MACS PEDIATRIC IMAGER
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.
03-2021

Table of contents
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................4
1.1 Read the instructions for use.................................................................................................................... 4
1.2 Read the instructions for use of combinable products............................................................................. 4
1.3 Scope........................................................................................................................................................4
1.4 Description of warning messages.............................................................................................................4
2 Normal use....................................................................................................................................................5
2.1 Intended use .............................................................................................................................................5
2.2 Indications for use.....................................................................................................................................5
2.3 Contraindications......................................................................................................................................5
2.4 Target user populations ............................................................................................................................ 5
2.5 Patient population.....................................................................................................................................5
3 Safety ............................................................................................................................................................6
3.1 Serious incidents ......................................................................................................................................6
3.2 Unsterile product ......................................................................................................................................6
3.3 Correct handling .......................................................................................................................................6
3.4 Damaged products ...................................................................................................................................6
3.5 National guidelines on airway management .............................................................................................6
4 Product description ......................................................................................................................................7
4.1 Product overview ......................................................................................................................................7
4.2 Overview of accessories ...........................................................................................................................8
4.3 Possible combinations..............................................................................................................................9
4.4 Technical data...........................................................................................................................................9
4.5 Ambient conditions ...................................................................................................................................9
4.6 Symbols on the packaging ..................................................................................................................... 10
5 Preparation..................................................................................................................................................11
5.1 Unpacking the product ...........................................................................................................................11
5.2 Inserting the C-MACS PEDIATRIC IMAGER into the blade...................................................................11
5.3 Connection to the C-MAC monitor .........................................................................................................11
5.4 Connection to the C-MAC pocket monitor.............................................................................................13
5.5 Connection to the C-HUB II....................................................................................................................13
6 Application ..................................................................................................................................................16
6.1 Using the C-MACS IMAGER..................................................................................................................16
6.2 Function of the multifunction button.......................................................................................................16
7 Disassembly................................................................................................................................................17
7.1 Disassembling the product ..................................................................................................................... 17
8 Maintenance, servicing, repairs, and disposal............................................................................................18
8.1 Repairing the product .............................................................................................................................18
8.2 Disposing of the product ........................................................................................................................18
9 Accessories and spare parts ......................................................................................................................19
9.1 Accessories.............................................................................................................................................19
10 Faults and messages ..................................................................................................................................20
10.1 Troubleshooting ......................................................................................................................................20
11 Electromagnetic compatibility.....................................................................................................................22
11.1 Electromagnetic compatibility ................................................................................................................22
12 Subsidiaries.................................................................................................................................................23

General information
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 4
1 General information
1.1 Read the instructions for use
If the instructions for use are not followed, patients, users, and third parties may be injured or
the product may be damaged.
Read the instructions for use carefully and follow all the safety notes and warnings.
Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products
If the instructions for use of combinable products are not followed, patients, users, and third
parties may be injured or the product may be damaged.
Read the instructions for use of the combinable products carefully and follow all the safety
notes and warnings.
1.3 Scope
These instructions for use are valid for the following products:
– C-MACS PEDIATRIC IMAGER 8403XSP
– Connecting cable 8403X
– Pressure compensation cap 11025E
– Leakage tester 13242 XL
1.4 Description of warning messages
To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warning messages describe the following levels of
danger.
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.
NOTICE
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Normal use
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 5
2 Normal use
2.1 Intended use
C-MACS IMAGERs are used in conjunction with C-MACS video laryngoscopes for single use
and a monitor to visualize the respiratory tracts and the vocal cords during endotracheal
intubation and to inspect and examine the upper respiratory tract. C-MACS IMAGERs are
designed for transient use in invasive procedures through a body orifice and can be reused if
reprocessed properly.
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 population
There are no restrictions in terms of patient groups for this product.

Safety
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 6
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 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.
3.3 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.
3.4 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 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S PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 7
4 Product description
4.1 Product overview
4
1
2
3
5
6
7
8
1 Telescope
2 C-MACS PEDIATRIC IMAGER
3 Socket for video connecting cable
4 Multifunction button (BlueButton)
5 Connection for leakage tester or pressure compensation cap
6 Video connecting cable
7 Connection socket for connection to the monitor
8 Connection socket for connection to the C-MACS PEDIATRIC IMAGER

Product description
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 8
4.2 Overview of accessories
1
2
3
1 C-MAC® monitor 8403 ZX
2 C-MAC®S video laryngoscope blade for single use
3 C-MAC®S video laryngoscope blade for single use, with attached
C-MAC® S PEDIATRIC IMAGER and connected
C-MAC® POCKET MONITOR 8403XD

Product description
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 9
4.3 Possible combinations
The C-MACS PEDIATRIC IMAGER requires additional accessories for normal use:
– C-MACS video laryngoscope blade
– Camera control unit (CCU), unless integrated in the monitor
– Monitor
C-MACS PEDI-
ATRIC IMAGER
C-MACS
video laryn-
goscope
blade
Monitor Camera control unit
C-MACS
PEDIATRIC
IMAGER
8403XSP
051111-01 C-MAC POCKET MONITOR
8403XD
C-MAC monitor 8403ZX (software
version: 704v300 or higher)
External monitor (in combination
with C-HUB II)
C-HUB II 20290301
For use with an exter-
nal monitor
(software version:
721v105 or higher)
051110-01
4.4 Technical data
C-MACS PEDIATRIC IMAGER 8403XSP
Classification IEC class n/a
Line frequency DC
Voltage 5V
Power input 2VA
Immersion protection IPX8
Illumination LED, white, 1W
Camera technology CMOS
Resolution 320 x 240 pixels
Weight 120g
4.5 Ambient conditions
There are no special transport and storage conditions for this product.

Product description
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 10
4.6 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Unique Device Identifier
Article no.
Number of products in the product packaging
Serial number
Consult the printed or electronic instructions for use
Not MR safe
Federal (USA) law restricts this device to sale by or on the order of a
physician.
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.

Preparation
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 11
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 Inserting the C-MACS PEDIATRIC IMAGER into the
blade
1. Open the package containing the C-MACS video laryngoscope blade you intend to use.
2. Push the C-MACS PEDIATRIC IMAGER into the mount of the C-MACS video
laryngoscope blade.
ðThe C-MACS PEDIATRIC IMAGER locks into place with an audible click.
Check that the C-MACS PEDIATRIC IMAGER is securely in place in the C-MACS video
laryngoscope blade by gently moving it (to the right and left). The distal end of the C-
MACS PEDIATRIC IMAGER must lie flat on the lens of the C-MACS video laryngoscope
blade.
The C-MACS PEDIATRIC IMAGER can be removed from the C-MACS video
laryngoscope blade during operation and inserted into another C-MACS video
laryngoscope blade.
5.3 Connection to the C-MAC monitor
The C-MACS PEDIATRIC IMAGER 8403XSP can only be connected to the C-MAC
monitor 8403ZX or 8404ZX. Older monitor types (8402/8401ZX) are not compatible.
1. Connect the video connecting cable to the connection socket on the C-MACS
PEDIATRIC IMAGER. The orientation pin on the video connecting cable and connection
socket facilitates connection.

Preparation
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 12
2. Make sure that the cable is fully inserted. There must not be a gap.
3. Connect the video connecting cable coming from the C-MACS PEDIATRIC IMAGER to
the connection socket at the side...
4. ...or at the rear of the C-MAC monitor.
5. Switch on the monitor by pressing the power switch. The green power switch lamp on
the monitor and the blue multifunction button on the C-MACS PEDIATRIC IMAGER light
up. The devices are now ready for use.

Preparation
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 13
The C-MAC monitor 8403ZX/8404ZX enables two KARL STORZ CMOS video units to be
connected with Lemo connectors. Video units from other manufacturers cannot be
connected. If two cameras are connected, the user must select the camera for which the
images are to be displayed in the menu (refer to the instructions for use for the C-MAC
monitor 8403ZX/8404ZX).
5.4 Connection to the C-MAC pocket monitor
The C-MACS PEDIATRIC IMAGER can only be connected to the C-MAC PM 8403 XD.
The 8401 XD model is not compatible.
1. Connect the C-MAC PM to the connection socket on the C-MACS PEDIATRIC IMAGER.
The orientation pin on the plug of the C-MAC PM and the socket of the video
laryngoscope blade facilitates connection.
2. Make sure that the C-MAC PM plug is fully inserted. There must not be a gap.
The monitor can also be opened up when connecting both components.
The devices are now ready for use. Once the C-MAC PM has been opened up, the TFT display
will be activated and the multifunction button on the C-MACS IMAGER will light up blue.
As soon as the multifunction button on the C-MACS PEDIATRIC IMAGER lights up blue, a
blue information bar will appear on the C-MAC PM monitor for a few seconds. It is now
possible to record images and videos.
5.5 Connection to the C-HUB II
The C-MACS PEDIATRIC IMAGER can only be connected to the C-HUB II 20290301
(software version 721v105 or later). Older models are not compatible.

Preparation
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 14
The C-HUB II with serial number 3044 and above is supplied with the latest software.
Please check whether a live image is displayed if you have a C-HUB II with a serial
number lower than 3044. If no live image is displayed, a software update is required for
the C-HUBII.
1. Connect the video connecting cable to the socket on the C-MACS PEDIATRIC IMAGER.
The orientation pin on the video connecting cable and connection socket facilitates
connection.
2. Make sure that the cable is fully inserted. There must not be a gap.
3. Connect the video connecting cable coming from the C-MACS PEDIATRIC IMAGER to
the video input on the front of the C-HUB II.
4. Connect the monitor to the S-Video or HDMI output on the rear of the C-HUB II.
5. Connect the power supply unit to the C-HUB II.

Preparation
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 15
ðThe lamp on the front of the C-HUB II and the multifunction button on the C-MACS
PEDIATRIC IMAGER light up permanently. The devices are now ready for use.

Application
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 16
6 Application
6.1 Using the C-MACS IMAGER
The high-intensity light emitted by the C-MACS IMAGER can result in increased
temperatures at the light outlet. However, these always stay below the value which could
cause burns.
6.2 Function of the multifunction button
The multifunction button on the C-MACS PEDIATRIC IMAGER can be used to activate single
image capture and video recording for documentation purposes. Documentation with the
multifunction button on the C-MACS PEDIATRIC IMAGER can be performed in conjunction
with the C-MAC monitor 8403ZX and C-MAC PM 8403XD.
Approx. 5seconds after the C-MAC PM 8403XD is switched on each time, a blue bar is
displayed at the top of the screen for a few seconds. It is now possible to record data for
documentation purposes. The remaining memory capacity in minutes is shown on the
left-hand side, while the name of the directory in which the saved data is stored is shown
on the right. If memory capacity is less than 10minutes, the bar is displayed in orange-
red.
Data can only be stored on the C-MAC monitor 8403ZX or 8404ZX if there is an SD
memory card inserted into the monitor.
Single image capture
Briefly press the multifunction button to activate single image capture.
ðThe current image on the screen is saved on the SD memory card inserted into the
connected monitor 8403ZX/8404ZX or in the internal memory of the C-MAC PM
8403XD.
ðDuring single image capture, the multifunction button briefly lights up green and then
switches back to blue.
Video recording
2. Press the multifunction button for around 2seconds to start video recording.
ðThe video recording is saved on the SD memory card inserted into the connected
monitor C-MAC monitor 8403ZX or in the internal memory of the C-MAC PM 8403XD.
ðDuring video recording, the multifunction button flashes green. A flashing red dot
appears in the top-left corner of both monitor screens.
3. Press the multifunction button again to stop the video recording.
ðThe video recording stops.
ðThe multifunction button switches to blue and the flashing red dot goes out.
The video stream can only be viewed on a PC if an MPEG 4 codec is installed on the PC.

Disassembly
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 17
7 Disassembly
7.1 Disassembling the product
1. Push on the ejection mechanism on the side of the C-MAC® S laryngoscope blade.
2. Take hold of the C-MAC® S PEDIATRIC IMAGER by the coupling mechanism between
the connecting cable or C-MAC® PM and C-MAC® S PEDIATRIC IMAGER and pull the
IMAGER out of the C-MAC® S video laryngoscope blade.
3. Remove the connecting cable or C-MAC® PM from the C-MAC® S PEDIATRIC IMAGER.

Maintenance, servicing, repairs, and disposal
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 18
8 Maintenance, servicing, repairs, and disposal
8.1 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).
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.
8.2 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
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 19
9 Accessories and spare parts
9.1 Accessories
Item Order number
MAGILL forceps, modified by BOEDEKER, length 25cm, suitable for the
endoscopic removal of foreign bodies, for use with video laryngoscopes of
sizes 2–4
809125
Protection cap, for the C-MAC, system interface to C-MAC, video laryngo-
scope 8403xxx, and C-MAC PM 8403XD, as well as C-MAC connecting
cable 8403X, for protecting the plug contacts during reprocessing, cap is
reusable, for use with: C-MAC connecting cable 8403X, C-MAC PM
8403XD, C-MAC video laryngoscopes 8403xxx, electronics modules
8401X/8402X, and flexible intubation video endoscopes (FIVEs)
8403YZ
Leakage tester, with blower and manometer 13242XL
PM connecting cable, for the transmission of digital signals from C-MAC
PM 8403XD to C-MAC video laryngoscopes 8403xxx (C-MAC system in-
terface), length 50cm
8403XDP

Faults and messages
Instructions for use • C-MACS PEDIATRIC IMAGER • PNO713_EN_V1.0_03-2021_IFU_CE-MDR 20
10 Faults and messages
10.1 Troubleshooting
Description of issue Possible causes Remedy
Cloudy picture, stripes,
streaks, or similar.
– Lens of the C-MACS
video laryngoscope
blade for single use is
soiled.
– Lens of the C-MACS
PEDIATRIC IMAGER is
soiled
– Use a new C-MACS
video laryngoscope
blade for single use.
– Clean the optical
surface of the image
chip and LED
illumination on the C-
MACS PEDIATRIC
IMAGER with a cotton
tip applicator soaked in
70% isopropyl alcohol.
Complete failure of the de-
vice. Possible lighting up of
status display.
– Power supply failure.
– Loose connection
between power supply
plug and socket on
device
– System error
– Check the power
supply.
– Push the power supply
plug firmly into the
socket on the device.
– Reset.
No picture, TFT screen dark – Connecting cable to C-
MAC monitor/C-MAC
PM not connected
properly
– Defective camera
electronics.
– TFT screen defective.
– Connect the connecting
cable to the C-MAC
monitor/C-MAC PM
correctly
– Send C-MAC PM or
supply unit to KARL
STORZ for repair.
Color distortions – White balance not
carried out correctly.
– C-MACS PEDIATRIC
IMAGER defective.
– Carry out new white
balance.
– Send supply unit to
KARL STORZ for repair.
Color rendering alternates. – Camera connecting
cable is defect.
– Have a new camera
connecting cable fitted.
Image cannot be saved – No memory card
inserted
– Memory card full
– Memory card is not
recognized
– Insert the memory card
while the C-MAC
monitor is switched off
– Change memory card
– Insert the memory card
while the C-MAC
monitor is switched off
and then switch the
monitor on again
– Perform reset