Nura Video larygoscope for endotracheal intubation Instructions for Use Ver 3.3 Nov 2020

Copyright © 2020, Carl Zeiss Meditec AG, Jena Trademarks ZEISS NURA is a trademark or registered trademark of Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany and/or other countries. All other brands mentioned in this document are the property of their respective owners.

Instructions for Use ZEISS NURA

Table of Contents

Table of Contents 1

Notes on the instructions for use ...

7

1.1

Product name ...

7

1.2

Scope...

7

1.3

Purpose and storage of the documentation ...

7

1.4

Questions and comments ...

7

1.5 1.5.1 1.5.2

Conventions in this document ... Conventions in all text areas... Conventions in a course of action...

7 8 8

1.6

Other applicable documents ...

9

2

Safety notes ... 11

2.1

Target group ... 11

2.2

Area of use ... 11

2.2.1 2.2.2 2.2.3 2.2.4

Intended use ... Indications... Normal use... Risks and side-effects ...

2.3

Responsibilities and duties of the operator ... 13

2.3.1 2.3.2 2.3.3 2.3.4 2.3.5 2.3.6 2.3.7 2.3.8 2.3.9 2.3.10

Risks resulting from operation on the part of insufficiently qualified personnel ... Risks resulting from product modifications ... Risks resulting from illegible markings ... Risks resulting from insufficient protective measures ... Risks resulting from transportation in unsuitable packaging... Risks resulting from product damage... Risks resulting from delayed startup of the display device ... Risks resulting from improper replacement of batteries ... Risks resulting from improper disposal... Messages to manufacturer and authorities ...

2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7 2.4.8

Measures and duties of the operator... 15 Risks resulting from reuse or reuse after reprocessing... 15 Risks resulting from insufficient operating experience... 15 Risks resulting from incompatibility... 16 Risks resulting from product damage... 16 Risks resulting from energized components ... 16 Risks resulting from unsuitable ambient conditions... 17 Risks resulting from non-observance of symbols and markings ... 17 Risks resulting from false diagnosis based on video images ... 17

3

Product description ... 19

3.1

Product components ... 19

3.2

Operating principle... 20

3.3

Control and display elements ... 20

3.4

Markings ... 22

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11 12 12 13 13 13 14 14 14 14 14 15 15 15

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Table of Contents

Instructions for Use ZEISS NURA

3.4.1 3.4.2

Markings on the product... 22 Markings on the packaging ... 23

4

Before use ... 27

4.1

Removing the laryngoscope from the packaging... 27

4.2

Performing a visual check... 27

4.3

Charging the display device ... 27

4.4

Activating the display device ... 29

4.5

Connecting the product components... 30

4.6

Performing a functional test... 32

5

Operation ... 35

6

After use ... 37

6.1

Disconnecting the product components ... 37

6.2

Disinfecting the display device ... 39

7

Error indications... 41

8

Troubleshooting... 43

9

Technical specifications... 45

9.1

Regulatory information ... 45

9.2

Essential performance ... 45

9.3

Laryngoscope information... 45

9.4

Display device information ... 45

9.5

Charger information ... 45

9.6

Disinfectant information... 46

9.7

Ambient requirements for operation ... 46

9.8

Ambient requirements for transport and storage ... 46

9.9 9.9.1 9.9.2

Guidelines and manufacturer’s declaration for electromagnetic compatibility ... 47 EMC - Electromagnetic compatibility as per IEC 60601-1-2: 2007 (3rd Edition) ... 47 EMC Electromagnetic compatibility IEC 60601-1-2: 2014 (4th Edition) ... 51

10

Accessories and components ... 55

11

Disposal ... 57

11.1

Packaging disposal ... 57

11.2

Display device disposal ... 57

11.3

Laryngoscope disposal... 58

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Instructions for Use ZEISS NURA

Table of Contents

Glossary ... 59 Index ... 61

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Empty page, for your notes

Instructions for Use ZEISS NURA

1 Notes on the instructions for use 1.1 Product name

1 Notes on the instructions for use 1.1 Product name ZEISS NURA is a video laryngoscope for endotracheal intubation and is referred to as the "product" in these Instructions for Use.

1.2 Scope The present Instructions for Use apply to the ZEISS NURA with software release 1.0 and the following identification: • Reference number, Mac3: 303170-0000-000 • Reference number, Mac4: 303170-0001-000

1.3 Purpose and storage of the documentation These Instructions for Use explain the safety features, functions, and performance parameters of the product. They help you to use the product safely and describe the proper measures for care and maintenance of the product. The correct handling of the product is vital for its safe and effective operation. u

Read these Instructions for Use before commissioning and using the product.

u

Keep the Instructions for Use accessible for all users at all times.

u

Pass on the Instructions for Use to the subsequent owners of the product.

1.4 Questions and comments u

If you have questions or comments concerning these Instructions for Use or the device itself, contact ZEISS Service.

You can find the ZEISS contact partner for your country online on the following page: www.zeiss.com/med.

1.5 Conventions in this document Certain types of information are specially marked in this document for better recognition.

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1 Notes on the instructions for use 1.5 Conventions in this document

Instructions for Use ZEISS NURA

1.5.1 Conventions in all text areas • This is a list. – This is a second level list. This is a cross-reference: Conventions in this document [} 7]. This is highlighted text. This is software code or program text. Names of software dialogs, fields or menus, and software messages are marked by quotation marks: • "View" menu. • "Do you want to save the settings?" The steps in menu and file paths are separated by slashes: • "File / Save as" • "My documents / Documents" Keys, buttons, knobs, levers, and other operating controls are marked by square brackets: • [START] key • [Next] button

1.5.2 Conventions in a course of action

WARNING!

This is warning information about hazards that can cause death or severe injuries if not avoided. The warning message names the possible consequences. u

CAUTION!

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause injuries if not avoided. The warning message names the possible consequences. u

NOTE

This is a measure with which hazards can be prevented.

This is warning information about hazards that can cause property damages if not avoided. The warning message names the possible consequences. u

This is a measure with which hazards can be prevented.

þ This is a requirement that must be met before the start of a sequence of actions. 1. This is a command. 2. CAUTION! This is a warning message about hazards that can occur during a single action. This is a command. ð This is the result of a sequence of actions.

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1 Notes on the instructions for use 1.6 Other applicable documents

1.6 Other applicable documents

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Document type

Document title

Operator's manual

Samsung Galaxy S10e user manual

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Instructions for Use ZEISS NURA

2 Safety notes 2.1 Target group

2 Safety notes 2.1 Target group This operator's manual is intended for physicians, medical and technical staff, and nurses who are experienced in the use of video laryngoscopes and who are responsible for preparing or operating the product. It is the duty of the equipment owner/operator to train and instruct all operating personnel.

2.2 Area of use 2.2.1 Intended use The product is designed to provide an indirect view of the oropharynx and the larynx up to the vocal cords in order to support the intubation process.

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2 Safety notes 2.2 Area of use

Instructions for Use ZEISS NURA

2.2.2 Indications Endotracheal intubation is often an emergency procedure performed on patients who are unconscious or who cannot breathe on their own. Endotracheal intubation is also performed using anesthesia before scheduled surgeries or medical procedures. Intended medical indication for use Medical discipline:

Intubation is performed whenever a patient needs to be artificially ventilated in order to keep the respiratory tract stable and unobstructed. • Endotracheal intubation under anesthesia

Indication:

Tracheal intubation performed on anatomical adult patients in intensive care units or in surgical procedures

Contraindication:

• Serious respiratory tract injuries or obstruction of the respiratory tract which prevent the safe passage of the product and an endotracheal tube • Injury resulting in instability of the spine, or the complete immobilization of the cervical spine • Significantly reduced mobility of the lower jaw • Protruding front teeth • Expectedly difficult respiratory tract

Patient target group:

Unconscious patients or patients who cannot breathe on their own

Age:

Anatomical adults

Gender:

Any gender

2.2.3 Normal use The product is intended to be predominantly used in hospitals to perform endotracheal intubations quickly and safely.

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2 Safety notes 2.3 Responsibilities and duties of the operator

2.2.4 Risks and side-effects Apart from the risks typically associated with intubation, the following known clinical risks exist when using laryngoscopes: • Serious injury to the structures of the mouth (e.g. the teeth) • Serious injury to the structures of the hypopharynx • Serious injury to the structures of the larynx • Serious injury to the jaw joint • Nerve damage • Bleeding • Infection • Hoarseness • Sore throat • Allergic reaction

2.3 Responsibilities and duties of the operator 2.3.1 Risks resulting from operation on the part of insufficiently qualified personnel Operator error and patient injury may result if the product is used by untrained personnel. u

Make sure that the operating personnel are appropriately trained and instructed.

u

Make sure that the operating personnel have read and understood the Instructions for Use.

u

Keep the Instructions for Use available at all times for the operating personnel.

u

To facilitate access for the entire operating personnel: If necessary, request further copies of the instructions for use from ZEISS.

u

Specify the competencies for handling the product and state who is authorized to perform what tasks.

2.3.2 Risks resulting from product modifications

CAUTION!

Risks resulting from modifications to the display device Modifying the display device may result in device malfunction and patient injury. u

Do not modify the display device's software.

u

Do not install any additional apps on the display device.

Modifying the product may result in malfunction and patient injury. u

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Do not modify the product, its hardware or its software.

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2 Safety notes 2.3 Responsibilities and duties of the operator

Instructions for Use ZEISS NURA

2.3.3 Risks resulting from illegible markings Missing or illegible markings on the product may result in misuse of the device. u

Make sure that the symbols and markings attached to the product are in good, legible condition.

2.3.4 Risks resulting from insufficient protective measures If insufficient protective measures are used, the operating personnel and the patient may become infected or be injured. u

Provide the necessary protective clothing.

u

Regularly check compliance with the national laws and regulations concerning accident prevention and occupational health.

2.3.5 Risks resulting from transportation in unsuitable packaging Transporting the product in unsuitable packaging may result in damage to the device. u

When transporting the device over long distances (e.g. change of location, returning the device for repair, etc.), use only the original packaging or special return packaging.

2.3.6 Risks resulting from product damage Using a damaged or non-disinfected product may lead to injury or infection. The product may only be used if it has been disinfected, is free of damage, and is in full working order. u

Ensure that a functional alternative (e.g. a conventional laryngoscope) is always available in the event the product cannot be used or if a successful intubation cannot be performed with the product.

u

Establish suitable routines to ensure that the product is always disinfected before being used.

2.3.7 Risks resulting from delayed startup of the display device It may take several minutes for the display device to become operational after being turned on. In the case of urgent intubation procedures, the display device may take too long to start up, and hence cannot be used. u

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Ensure that the display device is left on permanently so that the product can be used quickly in urgent cases.

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Instructions for Use ZEISS NURA

2 Safety notes 2.4 Measures and duties of the operator

2.3.8 Risks resulting from improper replacement of batteries High temperatures, fire and explosion may result if lithium-ion batteries are not replaced properly. u

Never attempt to replace the display device battery.

2.3.9 Risks resulting from improper disposal Improperly disposing of waste or materials contaminated with bacteria or viruses may lead to illness. u

Follow the disposal procedures for hospital waste and/or materials contaminated with bacteria or viruses.

u

Comply with the legal requirements in your country for waste disposal.

u

Avoid any possible contamination of people and/or the environment.

2.3.10 Messages to manufacturer and authorities If a serious incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report this serious incident to the manufacturer or seller of the medical product. In the European Union, the operator must report this serious incident to the responsible authorities in the applicable country.

2.4 Measures and duties of the operator 2.4.1 Risks resulting from reuse or reuse after reprocessing The laryngoscope may not be used more than once. Reuse may result in patient infection. Reuse after reprocessing can cause infections or allergic reactions due to process media residuals. Reprocessing can compromise the product's physical condition and lead to patient injuries. u

Do not use the laryngoscope more than once under any circumstances.

2.4.2 Risks resulting from insufficient operating experience Using the product without sufficient training may result in injury to patients. u

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Do not use the product unless you are adequately trained in handling it.

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2 Safety notes 2.4 Measures and duties of the operator

Instructions for Use ZEISS NURA

2.4.3 Risks resulting from incompatibility Connecting incompatible components to the product may result in malfunction and injure the patient. u

Only use components approved and supplied by ZEISS.

u

Do not modify the product, its hardware or its software.

u

Do not modify the display device under any circumstances.

u

Do not insert any SIM cards into the display device.

u

Only use the USB port on the display device to connect the display device to the laryngoscope or a suitable charger. Do not connect any other devices to the USB port on the display device.

2.4.4 Risks resulting from product damage Using a damaged or non-disinfected product may lead to injury or infection. The product may only be used if it has been disinfected, is free of damage, and is in full working order. u

Do not use the product if there is any evidence of damage to the laryngoscope packaging.

u

Before using the product, conduct a visual inspection to ensure that it is not damaged. [} 27]

u

Conduct a functional test before each use of the product to ensure that it is fully functional. [} 32]

u

Before each use of the product, check the status of the display device battery to ensure that the charge level will suffice to perform the full procedure.

u

Disinfect the display device after each use. [} 39]

2.4.5 Risks resulting from energized components

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u

Please observe the information on electromagnetic compatibility. [} 47]

u

Never open the housing of the display device.

u

Never open the housing of the laryngoscope.

u

Position the charger in such a way that it can be easily unplugged from the electric power supply.

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Instructions for Use ZEISS NURA

2 Safety notes 2.4 Measures and duties of the operator

2.4.6 Risks resulting from unsuitable ambient conditions Risks resulting from unsuitable ambient conditions

CAUTION!

Using the product in unsuitable ambient conditions may lead to damage, malfunction or injury. u

Operate the product only within the limits of the prescribed ambient requirements. [} 46]

Using the product in unsuitable ambient conditions may lead to damage, malfunction or injury. u

Do not operate the product in explosive hazardous areas.

u

Maintain a minimum distance of 25 cm between the product and flammable anesthetics or volatile solutions such as alcohol, petroleum ether and similar substances.

u

Please observe the information on electromagnetic compatibility. [} 47]

u

To not position or operate the product close to magnetic resonance scanners.

u

Maintain a minimum distance of 30 cm between the product and devices which produce a strong electromagnetic field.

2.4.7 Risks resulting from non-observance of symbols and markings Non-observance of product markings may result in misuse of the device. u

Observe the symbols and markings attached to the product!

2.4.8 Risks resulting from false diagnosis based on video images The product is not intended for diagnostic purposes. Videos displayed on the device may contain deviations regarding their scale, shape, color and contrast. u

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Do not use the live camera picture for diagnostic purposes.

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3 Product description 3.1 Product components

3 Product description 3.1 Product components 2 3 1

6 4

5 Figure 1: Product components 1

USB-C plug

2

Display device mount (moveable part)

3

Display device (type: Galaxy S10e)

4

Laryngoscope

5

Camera and LED

6

USB cable

The laryngoscope is a single-use product and may not be re-used. The display device can be wiped down with disinfectant up to 100 times. The display device should only be charged using the charger included in the scope of delivery (TA 200).

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3 Product description 3.2 Operating principle

Instructions for Use ZEISS NURA

3.2 Operating principle When the display device is turned on and connected to the laryngoscope via the USB cable, it supplies power to the camera and the light source on the laryngoscope. The laryngoscope's ergonomic shape allows it to be inserted into the patient's throat. The laryngoscope illuminates the visual field and captures a live video picture which is shown on the display device. The live camera view facilitates the identification of anatomical landmarks in the hypopharynx and hence the controlled insertion of the endotracheal tube. Note: The display device can only be used to display the live camera view of ZEISS NURA. Using the display device on a mobile network, even to make emergency calls, is not possible. All of the display device's mobile and data transfer functions have been disabled. Apart from the on/off button, all buttons on the display device have been disabled.

3.3 Control and display elements 2

3

1

4

5

Figure 2: Display device, control and display elements in status mode 1

USB-C port

2

"Battery status" symbol

3

Speaker

4

On/Off button

5

Live camera view

The symbols below will appear on the display depending on the device's operating status. Symbol

Name Battery status

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Explanation • Shows the battery charge level: – Solid white: the battery charge level is above 20%.

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