Flexible intubation videoendoscopes Instructions for Use BMF168 Ver1.0 Feb 2021

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... 7 2.1 Intended use ... 7 2.2 Indications... 7 2.3 Contraindications... 8 2.4 Target user populations ... 8 2.5 Patient groups... 8 3 Safety ... 9 3.1 Serious incidents ... 9 3.2 Damaged products ... 9 3.3 Correct handling ... 9 3.4 Unsterile product ... 9 3.5 Single-use product ... 9 3.6 Observing ambient conditions ... 10 3.7 Combination with other components ... 10 3.8 Hot components ... 10 3.9 High light intensity ... 10 3.10 Patient leakage current ... 10 3.11 HF applied parts ... 10 3.12 Malfunction ... 10 4 Product description ... 11 4.1 Product overview ... 11 4.2 Possible combinations... 12 4.3 Technical data... 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 ... 15 5 Preparation... 16 5.1 Unpacking the product ... 16 5.2 Assembling the product... 16 5.3 Connecting the C-MAC monitor ... 17 5.4 Connecting the C-HUB II ... 17 5.5 Checking the functions ... 18 6 Application ... 19 6.1 Switching on the product... 19 6.2 Operating the deflection mechanism... 19 6.3 Operating the function buttons ... 20 6.4 Using the working channel ... 21 6.5 Activating the suction function ... 21 7 Maintenance, servicing, repairs, and disposal... 22 7.1 Repairing the product ... 22 7.2 Disposing of the product ... 22 8 Accessories and spare parts ... 23 8.1 Accessories... 23 9 Electromagnetic compatibility... 24

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Table of contents

9.1 Electromagnetic Compatibility... 24 10 Faults and messages ... 25 10.1 Fault correction ... 25 11 Subsidiaries... 26

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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

Flex. intubation videoendoscope 5.5 x 65

11303BNX

Flex. intubation videoendoscope 6.5 x 65

11304BCX

Flex. intubation videoendoscope 3.0 x 51.5

11301ABX

Flex. intubation videoendoscope 5.5 x 65

11301BNX

Suction valve, reusable

11301CB1

Irrigation adapter

11301CD1

Suction valve for single use, 20x

11301CE1

Tube holder for videoendoscopes

11301CFX

Flex. intubation videoendoscope 4.0 x 65

11302BDX

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.

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General information

ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

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Normal use

2 Normal use 2.1 Intended use Flexible intubation endoscopes Flexible intubation endoscopes without working channel (CMOS) are used for both endotracheal and nasal intubation. Flexible intubation endoscopes without working channel (CMOS) are used for endoscopic visualization and image transmission for diagnosis of the upper and lower respiratory tract. Flexible intubation endoscopes without working channel (CMOS) are designed for transient use in invasive procedures through a body orifice. Flexible intubation endoscopes with working channel Flexible intubation endoscopes with working channel (CMOS) are designed for both endotracheal and nasal intubation. Flexible intubation endoscopes with working channel (CMOS) are designed for endoscopic visualization and image transmission as well as for creating an access to introduce additional instruments for diagnosis and treatment of the upper and lower airways. Flexible intubation endoscopes with working channel (CMOS) are intended for temporary use in interventions performed through natural orifices. Suction valve Unsterile single-use suction valves are used for interrupting the suction in conjunction with flexible endoscopes. Suction valves are non-invasive and are designed for transient or shortterm use in invasive procedures through a body orifice or surgically invasive procedures. Reusable suction valves are used for interrupting the suction in conjunction with flexible endoscopes. Suction valves are non-invasive and are designed for transient or short-term use in invasive procedures through a body orifice or surgically invasive procedures. Tube adapter Tube adaptors are used for fastening the ETT on the intubation endoscope. Tube adaptors are non-invasive and are designed for transient or short-term use in invasive procedures through a body orifice or surgically invasive procedures. Irrigation adapter A cleaning adaptor is used for connecting the existing interfaces of a medical device during reprocessing. Cleaning adaptors have no contact with the human body.

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

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Normal use

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.

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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 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.

3.3 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 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.

3.5 Single-use product The product must only be used once. Using the product more than once exposes patients, users, and third parties to a risk of infection and injury. Dispose of the product properly after using it once. Do not continue to use it.

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Safety

3.6 Observing ambient conditions If the device is stored, transported, operated or reprocessed under unsuitable conditions, patients, users or third parties may be injured and the device can be damaged. Observe the ambient conditions listed in the instructions for use and reprocessing.

3.7 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 make changes to the product if these changes are approved by KARL STORZ.

3.8 Hot components The high level of light intensity may cause the distal end, the light connections for the endoscope and fiber optic light cable, and adjacent components to heat up. This can cause burns to patients, users or third parties. Avoid contact with the distal end and light connections of the endoscope and fiber optic light cable.

3.9 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 of the endoscope or fiber optic light cable to heat up. Do not look into the light output of the endoscope or fiber optic light cable. Make sure the light output of the endoscope and the fiber optic light cable is sufficiently far away from tissue and operating accessories.

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 HF applied parts HF applied parts can injure patients, users, and third parties if there is unintentional contact. Do not place HF applied parts on the patient. Do not let HF applied parts come into contact with conducting objects or liquids. Check the product insulation for damage before each use. If the insulation is damaged or missing: Do not use the product.

3.12 Malfunction If the flexible videoendoscope is used while malfunctioning, the patient can be injured. Discontinue use immediately. Place the distal end of the videoendoscope in the straight position. Release the deflection lever. Remove the videoendoscope slowly and carefully from the patient.

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Product description

4 Product description 4.1 Product overview

1

2

3 4 5 6

10 9

7

8

1

Connecting cable

6

Working channel with leaflet valve

2

Function buttons

7

Tube holder

3

Suction valve

8

Sheath

4

Pressure compensation valve

9

Distal tip

5

Connection for suction valve/irrigation adaptor

10

Deflection lever

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Product description

4.2 Possible combinations The product can be combined with the following components: Product name

Article number

C-MAC Monitor

8403ZX

C-MAC Monitor

8404ZX

C-HUB II

20290320

TELE PACK +

TP101

Suction valve, reusable

11301CB1

Suction valve for single use

11301CE1

Suction valve

091011-01

Suction valve

091011-10

Irrigation adapter

11301CD

Tube holder for videoendoscopes

11301CFX

4.3 Technical data Flexible intubation videoendoscope 11304BCX Direction of view

0°

Angle of view

100°

Deflection

up 180°, down 140°

Working length

65 cm

Outside diameter of distal tip

6.5 mm

Working channel dimensions (H x W)

2.8 x 3.2 mm

Illumination

Integrated LED light source

Electrical power consumption

1W

Sensor

CMOS technology

Weight

425 g

Drip-water protection

IPX8

Flexible intubation videoendoscope 11301 BNX, 11303 BNX Direction of view

0°

Angle of view

100°

Deflection

up 140°, down 140°

Working length

65 cm

Outside diameter of distal tip

5.5 mm

Working channel dimensions

Ø 2.1 mm

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Product description

Flexible intubation videoendoscope 11301 BNX, 11303 BNX Illumination

Integrated LED light source

Electrical power consumption

1W

Sensor

CMOS technology

Weight

400 g

Drip-water protection

IPX8

Flexible intubation videoendoscope 11302BDX Direction of view

0°

Angle of view

100°

Deflection

up 140°, down 140°

Working length

65 cm

Outside diameter of distal tip

4.0 mm

Working channel dimensions

Ø 1.5 mm

Illumination

Integrated LED light source

Electrical power consumption

1W

Sensor

CMOS technology

Weight

385 g

Drip-water protection

IPX8

Flexible intubation videoendoscope 1130ABX Direction of view

0°

Angle of view

100°

Deflection

up 140°, down 140°

Working length

51.5 cm

Outside diameter of distal tip

2.8 mm

Illumination

Integrated LED light source

Electrical power consumption

1W

Sensor

CMOS technology

Weight

337 g

Drip-water protection

IPX8

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Product description

4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Article no.

Serial number

Batch code

Number of products in the product packaging

Unique Device Identifier

Consult the printed or electronic instructions for use

Unsterile

Fragile, handle with care

Keep away from sunlight

Keep dry

Not MR safe

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Product description

Symbol

Meaning Do not reuse

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 Start/stop video recording

White balance Save a still image

Serial number

Follow instructions for use

Applied part type BF

4.5 Ambient conditions Storage/transport conditions Temperature

0 °C ... 55 °C

Relative humidity (non-condensing)

15 – 90 %

Atmospheric pressure

700 – 1,080 hPa

Operating conditions Temperature

15 °C ... 40 °C

Relative humidity (non-condensing)

15 – 80 %

Atmospheric pressure

700 – 1,080 hPa

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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.

5.2 Assembling the product 1.

Place the sealing cap on the proximal end of the working channel.

2.

Place the suction valve on the valve connecting piece so that the tube connection is positioned above the function buttons and the unit's side nubs engage with the recesses on the connecting piece.

3.

Using gentle pressure, rotate the suction valve in a clockwise or counterclockwise direction until the suction valve noticeably engages.

4.

Push the tube holder from distal onto the cone of the flexible intubation videoendoscope until the tube holder is securely in place.

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Preparation

5.3 Connecting the C-MAC monitor 1.

Insert the connecting cable of the product into the serial port on the back or side of the C-MAC Monitor.

2.

To charge the battery, insert the power supply cord into the connection socket on the CMAC Monitor and plug it into the power supply.

3.

Attach the power cord to the connection socket using the swivel nut.

ð The orange LED illuminates. ð The battery charges automatically.

5.4 Connecting the C-HUB II 1.

Connect the power supply unit to the C-HUB II.

2.

Connect the video connecting cable of the product to the video input on the front of the C-HUB II.

3.

Connect the monitor to the S-Video output or HDMI output on the rear of the C-HUB II.

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Preparation

The image focus is adjusted automatically. Manual adjustment is not necessary.

5.5 Checking the functions 1.

Slowly move the deflection lever to check the deflection of the distal tip; see chapter Operating the deflection mechanism [p. 19].

2.

Check the suction; see chapter Activating the suction function [p. 21].

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Application

6 Application 6.1 Switching on the product 1.

Press the On/Off button on the C-MAC Monitor to switch the product on.

2.

Press the ON/OFF button again to switch the product off.

6.2 Operating the deflection mechanism WARNING Incorrect handling! Risk of injury! The patient can be injured if the deflection lever is moved with force or abruptly. Move the deflection lever with caution. WARNING Angled tip! Risk of injury! The patient can be injured if the distal end of the product is angled when being introduced into the patient or removed. Place the distal end of the product in the straight position. Do not carry the product by the sheath. Do not pull, clamp or twist the sheath. 1.

Take hold of the product in your left or right hand, as shown in the figures.

2.

Move the deflection lever upwards using the thumb to angle the distal tip downwards.

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Application

3.

Move the deflection lever downwards using the thumb to angle the distal tip upwards.

4.

To place the distal tip in the straight position, move the deflection lever until you hear a click.

6.3 Operating the function buttons The product is equipped with the following function buttons:

1

1

Start/stop video recording

2

White balance

2

3

3

Save a still image

The following functions are preset:

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