Storz C-MAC VS User manual

Instructions for use
C-MAC VS
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 VS • PNO715_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.................................................................................................................................................5
2.3 Contraindications......................................................................................................................................5
2.4 Target user populations ............................................................................................................................ 5
2.5 Patient groups...........................................................................................................................................5
3 Safety ............................................................................................................................................................6
3.1 Serious incidents ......................................................................................................................................6
3.2 Correct handling .......................................................................................................................................6
3.3 Correct reprocessing ................................................................................................................................6
3.4 National guidelines on airway management .............................................................................................6
4 Product description ......................................................................................................................................7
4.1 Product overview ......................................................................................................................................7
4.2 Technical specifications............................................................................................................................8
4.3 Possible combinations..............................................................................................................................8
4.4 Symbols on the packaging ....................................................................................................................... 8
4.5 Ambient conditions ...................................................................................................................................9
5 Preparation..................................................................................................................................................10
5.1 Unpacking the product ...........................................................................................................................10
5.2 Testing the product.................................................................................................................................10
5.3 Fitting the tube holder.............................................................................................................................10
5.4 Connecting the product to the C-MAC Monitor .....................................................................................10
5.5 Connecting the product to the C-MAC® Pocket Monitor ....................................................................... 11
5.6 Connecting the product to the C-HUB II ................................................................................................ 13
5.7 Focus ......................................................................................................................................................14
5.8 Assembling the endotracheal tube .........................................................................................................14
6 Application ..................................................................................................................................................16
6.1 Holding the product correctly ................................................................................................................. 16
6.2 Operating the deflection mechanism......................................................................................................16
6.3 Saving and documenting recordings...................................................................................................... 16
6.3.1 Saving a still image...................................................................................................................... 17
6.3.2 Recording videos......................................................................................................................... 17
7 Disassembly................................................................................................................................................18
7.1 Disassembling the product ..................................................................................................................... 18
8 Maintenance, servicing, repairs, and disposal............................................................................................19
8.1 Maintaining the product.......................................................................................................................... 19
8.1.1 Maintenance ................................................................................................................................ 19
8.2 Disposing of the product ........................................................................................................................19
9 Accessories and spare parts ......................................................................................................................20
9.1 Accessories.............................................................................................................................................20
10 Electromagnetic compatibility.....................................................................................................................21
10.1 Electromagnetic compatibility ................................................................................................................21
11 Faults and messages ..................................................................................................................................22
11.1 Product malfunctions..............................................................................................................................22
12 Subsidiaries.................................................................................................................................................24

General information
Instructions for use • C-MAC VS • PNO715_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
This instruction manual is valid for:
Product Article number
C-MAC VS 10331BX
C-MAC VS tube holder for ETT 10331BAX
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 VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 5
2 Normal use
2.1 Intended use
Intubation endoscopes with deflectable tip (CMOS) are used for endotracheal intubation and
for inspection of the upper and lower respiratory tract. Intubation endoscopes with deflectable
tip are designed for transient use in invasive procedures through a body orifice.
2.2 Indications
The use of intubation endoscopes is indicated if, in the opinion of the responsible physician, a
fiberoptic endotracheal intubation or inspection of the oropharyngeal, supraglottic, or
subglottic region is indicated or a percutaneous dilatational tracheostomy (PCT) is performed.
This includes, but is not limited to:
– Endotracheal intubation with a difficult respiratory tract
– Endoscopic inspection and monitoring of the mouth, nose, and throat region
– Monitoring of percutaneous tracheostomy
– Anesthesiological bronchoscopy
– Bronchial lavage
2.3 Contraindications
The use of the intubation endoscope is contraindicated if, in the opinion of the responsible
physician, the surgical method is contraindicated or the patient is not able to undergo surgery
or anesthesia due to his or her general condition. Intubation endoscopes must not be used for
interventions in direct contact with the central nervous system (CNS) and central
cardiovascular system. No other contraindications are known.
2.4 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.
2.5 Patient groups
There are no restrictions in terms of patient groups for this product.

Safety
Instructions for use • C-MAC VS • PNO715_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 Correct handling
If the product is not handled correctly, patients, users, and third parties may be injured.
Check the product for the following points before and after every use:
– Completeness
– Good working order
– Correct assembly of the components
– Functionality
3.3 Correct reprocessing
Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection.
Reprocess the product before use.
A validated reprocessing procedure must be followed and the product must be
reprocessed in line with the reprocessing instructions.
3.4 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 VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 7
4 Product description
4.1 Product overview
12
7
8
3456
C-MAC® VS (10331BX)
1 Distal tip 5 Deflection lever
2 Flexible sheath for deflection 6 Socket for video connecting cable
3 Tube holder 7 Multifunction button (BlueButton)
4 Handle 8 Ventilation pipe
2
1
Connecting cable (8403X)
1 Connection point for endoscope 2 Monitor connection socket
1
23
Tube holder (10331BAX)
1 Adaptor for tube fixing 3 Knurled screw
2 Connection for O2 insufflation

Product description
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 8
4.2 Technical specifications
Designation Value
Direction of view 0°
Angle of view 100°
Deflection ≥90° without tube
≥60° with tube
Working length 41cm
Outside diameter 5.5mm
Power input 1W
Sensor CMOS technology
Resolution 1280 x 800
Weight 445g
Degree of protection acc. to
IEC60259
IPX8
Electrical protection class II
4.3 Possible combinations
The product can be combined with the following components:
Monitor/CCU Connecting cable
C-MAC® Monitor (8403ZX) in software version704v300
or higher
8403X
C-HUB® II (20290301) in software version721v105
or higher
C-MAC® Monitor (8404ZX)
C-MAC® Pocket Monitor (8403XD) 8403XDP
A tube holder (10331BAX) can be used to fix the endotracheal tube to the instrument.
4.4 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Fragile, handle with care
Consult the printed or electronic instructions for use

Product description
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 9
Symbol Meaning
Not MR safe
Medical device
Unique Device Identifier
Article no.
Number of products in the product packaging
Serial number
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.
4.5 Ambient conditions
Storage/transport conditions
Temperature -20°C...+50°C
Relative humidity
(non-condensing)
5–95%
Air pressure 700–1.080hPa
Operating conditions
Temperature 0°C...40°C
Relative humidity
(non-condensing)
30–70%
Air pressure 700–1080hPa
The specifications for the atmospheric pressure can only be guaranteed if the pressure
compensation cap is fitted to the ventilation pipe during transportation.

Preparation
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 10
5 Preparation
5.1 Unpacking the product
1. Carefully remove the product and accessories from the packaging.
2. Check the delivery for missing items and evidence of shipping damage.
3. In the case of damage, hidden defects, and short deliveries, document their nature and
extent and contact the manufacturer or supplier immediately.
5.2 Testing the product
1. Inspect the product for visible contamination. Do not use if contaminated.
2. Inspect the product for the following characteristics:
– Good working order
– Functionality
– Correct assembly of the components
– Completeness
5.3 Fitting the tube holder
1. Push the tube holder onto the product from distal.
2. Fix the tube holder in place by turning the knurled screw clockwise.
5.4 Connecting the product to the C-MAC Monitor
Two CMOS video units can be connected to the C-MAC Monitor (8403ZX, 8404ZX) using
Lemo connectors. Both connections support all KARLSTORZ CMOS videoendoscopes.
1. Insert the plug of the connecting cable (8403X) into the serial port of the product until you
feel a resistance. At the same time, correctly line up the visible and tangible noses.

Preparation
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 11
2. Check whether the cable is fully inserted, no gap should be visible.
3. Attach the connecting cable to one of the two serial ports of the C-MAC Monitor
(8403ZX, 8404ZX).
4. Turn the monitor on using the power switch.
ðThe pilot lamp on the monitor lights up green.
ðThe multifunction button on the product lights up blue.
5. If two cameras are connected, select the camera for which images are to be displayed
from the menu.
ðThe product is ready for use.
The monitor can be removed and connected to a different videoendoscope during use.
5.5 Connecting the product to the C-MAC® Pocket Monitor
1. Insert the plug of the C-MAC Pocket Monitor into the serial port of the product until you
feel a resistance. At the same time, correctly line up the visible and tangible noses.

Preparation
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 12
2. Check whether the plug is fully inserted, no gap should be visible.
ðThe multifunction button on the product lights up blue.
ðThe product is ready for use.
It is not necessary to perform a white balance.
The C-MAC Pocket Monitor can be removed and connected to a different laryngoscope during
operation.
Each time the C-MAC Pocket Monitor (8403XD) is switched on, a blue bar briefly appears at
the top of the screen after approx. 5 seconds. Documentation is now possible. 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 the memory capacity is less than
10minutes, the bar is displayed in orange-red.

Preparation
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 13
The C-MAC Pocket Monitor display turns off automatically after 10 minutes. The display can
be turned back on again by closing and reopening it or by removing and inserting it.
5.6 Connecting the product to the C-HUB II
1. Insert the plug of the connecting cable (8403X) into the serial port of the product until you
feel a resistance. At the same time, correctly line up the visible and tangible noses.
2. Check whether the cable is fully inserted, no gap should be visible.
3. Attach the connecting cable to the video input on the front of the C-HUB II.

Preparation
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 14
4. Connect the monitor to the S-Video output or HDMI output on the rear of the C-HUB II.
ðThe multifunction button on the product lights up blue.
ðThe product is ready for use.
5.7 Focus
The image will focus automatically. Manual adjustment is not necessary.
5.8 Assembling the endotracheal tube
1. Push the endotracheal tube onto the product from distal.
2. Surround the distal tip of the product with the endotracheal tube.

Preparation
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 15

Application
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 16
6 Application
6.1 Holding the product correctly
1. Take hold of the product handle.
2. Use one hand to operate the product with the control handle.
Do not pull, clamp or twist the sheath of the intubation videoendoscope. The intubation
videoendoscope must not be carried by the sheath.
6.2 Operating the deflection mechanism
1. Check the deflection without the endotracheal tube threaded on
2. Press the deflection lever.
ðNo deflection: Distal tip in the neutral position
ðDeflection: ≥ 90° without tube, ≥ 60° with the endotracheal tube threaded on
3. If the view is impaired, move the distal tip into the neutral position before the tube is
placed through the vocal cords.
6.3 Saving and documenting recordings
Still images can be saved and video recordings can be documented using the multifunction
"BlueButton". The documentation procedure can be carried out using the C-MAC® Monitor
(8403ZX, 8404ZX) and the C-MAC® Pocket Monitor (8403XD).
Functions of the multifunction button are indicated as follows:

Application
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 17
Color Intensity Function
Blue Permanent The recording function is enabled.
Green Brief An image is being captured.
Pulsed A video is being recorded.
6.3.1 Saving a still image
Briefly press the multifunction button once.
ðThe current image on the screen is saved to the SD memory card in the monitor (8403ZX,
8404ZX) or to the internal memory of the C-MAC® Pocket Monitor.
6.3.2 Recording videos
1. Press the multifunction button for around 2 seconds to start video recording.
ðA flashing red dot appears on the monitor in the top, left corner of the screen.
ðThe video recording is saved either to the SD memory card in the monitor (8403ZX,
8404ZX) or to the internal memory of the C-MAC® Pocket Monitor.
2. Press the multifunction button again to stop video recording.
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 VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 18
7 Disassembly
7.1 Disassembling the product
1. Place the distal tip in the neutral position.
2. If necessary, pull off the endotracheal tube.
3. Pull the connecting cable off the C-MAC Monitor or C-HUB II. Remove the C-MAC
Pocket Monitor from the product.
4. Release the adaptor for the tube fixation by turning the knurled screw counterclockwise.
5. Carefully pull out the tube holder.

Maintenance, servicing, repairs, and disposal
Instructions for use • C-MAC VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 19
8 Maintenance, servicing, repairs, and disposal
8.1 Maintaining the product
If they are not described in more detail here, maintenance activities may only be performed by
KARLSTORZ or by a company authorized by KARLSTORZ.
8.1.1 Maintenance
The following maintenance intervals are recommended:
Interval Activity To be performed by
annually Safety test KARLSTORZ service techni-
cians
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 VS • PNO715_EN_V1.0_03-2021_IFU_CE-MDR 20
9 Accessories and spare parts
9.1 Accessories
Item Order no.
Endoscope holder for C-MAC® rigid Intuba-
tion Video Endoscope 10331 BX, made of
plexiglass, distal end open, for fixation to a
standard rail
10331BXH
C-MAC® Connecting Cable 8403X
C-MAC® Pocket Monitor connecting cable 8403XDP