QEVO and QEVO ECU Digital Exploration Tool and Control Unit Release 1.0 Instructions for Use Oct 2019

Copyright © 2019, Carl Zeiss Meditec AG, Jena Registered trademarks QEVO and QEVO ECU are trademarks or registered trademarks of Carl Zeiss Meditec AG or another company of the ZEISS group in Germany and/or other countries. All other brands in this document are the property of the respective owner.

Instructions for Use QEVO and QEVO ECU

Table of contents

Table of contents 1

Notes on the instructions for use ...

5

1.1

Product name ...

5

1.2

Scope...

5

1.3

Purpose and storage of the documentation ...

5

1.4

Questions and comments ...

5

1.5 1.5.1 1.5.2

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

5 6 6

1.6

Other applicable documents ...

7

2

Safety notes ...

9

2.1

Target group ...

9

2.2

Area of use ...

9

2.2.1 2.2.2 2.2.3

Intended use ... 9 Indications... 9 Normal use... 10

2.3 2.3.1 2.3.2

Responsibilities and duties of the operator ... 11 Network connection requirements ... 12 Messages to manufacturer and authorities ... 12

2.4

Measures and duties of the operator... 13

2.5

Electromagnetic compatibility ... 14

3

Product description ... 15

3.1

Labeling... 15

3.1.1 3.1.2 3.1.3

Labeling on the product ... 15 Labeling on the packaging ... 17 Labeling on the connector panel of the control unit ... 21

3.2

Design of the product... 24

3.3

Control unit ... 25

3.4

Functional description ... 25

4

Before every use... 27

4.1

Sterile reprocessing ... 27

4.2

Visual inspection of the product ... 27

4.3

Configure KINEVO 900 for use of the product... 27

4.4

Connect the product to the control unit ... 28

4.5

Function test ... 30

4.6

Visual inspection of the connector panel of the control unit ... 31

4.7

Mount the product on the supporting arm system ... 32

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Table of contents

Instructions for Use QEVO and QEVO ECU

4.8

Incorporate product in navigation system ... 33

5

Operation ... 35

5.1

Working with the product ... 36

5.2

Switching the product off and precleaning it ... 38

6

Reprocessing ... 41

7

Maintenance ... 43

7.1 7.1.1 7.1.2

Maintenance concepts... 43 Maintenance via replacement concept ... 44 Direct maintenance ... 45

7.2

Implement technical safety test... 46

8

Troubleshooting... 47

8.1 8.1.1 8.1.2 8.1.3

Localizing faults... 47 Response to faults with messages ... 47 Send the product in for repair ... 48 Service information ... 48

8.2

Faults on the product ... 48

9

Technical specifications... 51

9.1

Conformity ... 51

9.2

Dimensions and weights... 52

9.3

Electrical data... 52

9.4

Light source... 52

9.5

Ambient requirements for operation ... 52

9.6

Ambient requirements for transport and storage ... 52

9.7 9.7.1 9.7.2

Guidelines and manufacturer’s declaration for electromagnetic compatibility ... 53 EMC Electromagnetic compatibility IEC 60601-1-2: 2007 (3rd Edition) ... 53 EMC Electromagnetic compatibility IEC 60601-1-2: 2014 (4th Edition) ... 58

10

Accessories and spare parts ... 61

11

Disposal ... 63

11.1

Disposal of the original packing ... 63

11.2

Disposal of the product and control unit ... 63

Glossary ... 65 Keyword index ... 67

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Instructions for Use QEVO and QEVO ECU

1 Notes on the instructions for use 1.1 Product name

1 Notes on the instructions for use 1.1 Product name QEVO is a hand-held digital exploration tool which is designated as "product" in these Instructions for Use. QEVO ECU is the so-called "control unit" for the exploration tool.

1.2 Scope The present Instructions for Use apply to QEVO and QEVO ECU with Software Release 1.0 and the following identification: • Reference number for QEVO: 7212 • Reference number for QEVO ECU: 7213

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 proper measures for care and maintenance of the product. The correct operation of the product is vital for safe and successful operation. u

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

u

Keep the Instructions for Use where they are accessible for all users at all times.

u

Give the Instructions for Use to the subsequent owners of the product.

1.4 Questions and comments u

If you have any questions or information on these Instructions for Use or the software, please contact ZEISS Service.

You can find the ZEISS contact partner for your country on the following website: 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 QEVO and QEVO ECU

1.5.1 Conventions in all text areas • This is a list. – This is a second level list. This is a cross-reference: Questions and comments [} 5]. This is bold type. 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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Instructions for Use QEVO and QEVO ECU

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

Kurz-Gebrauchsanweisung

G-30-1977 QEVO

Reprocessing instructions

G-30-1989 QEVO

INSTRUCTIONS FOR USE

G-30-2047 KINEVO 900 SW1.6

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Empty page, for your notes

Instructions for Use QEVO and QEVO ECU

2 Safety notes 2.1 Target group

2 Safety notes 2.1 Target group The present Instructions for Use are intended for physicians, medical and technical staff and nurses who prepare and operate the product after receiving appropriate instruction. It is the duty of the equipment owner/operator to train and instruct all operating personnel. The intended usage site for the product is operating rooms in clinics and hospitals.

2.2 Area of use 2.2.1 Intended use QEVO The product is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

QEVO ECU The product is intended to operate an endoscopic device and to provide a high resolution video signal to a monitor.

2.2.2 Indications Information on the indication of use, contraindications and the target patient group is set out in the following table. Indication of use Discipline:

• Neurosurgery and spine surgery • Orthopedic surgery • Oral and maxillofacial microsurgery • P&R procedure • Not applicable for ophthalmology

Indication:

The QEVO is intended for viewing internal surgical sites during general surgical procedures and for visualizing ventricles and structures within the brain during neurological surgical procedures. The QEVO ECU is intended to operate an endoscopic device and to provide a high resolution video signal to a monitor.

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2 Safety notes 2.2 Area of use

Instructions for Use QEVO and QEVO ECU

Indication of use Contraindication:

The product is contraindicated for treatments in which the endoscopic method is contraindicated.

Patient target group:

No restriction

Age:

No restriction

Gender:

All

2.2.3 Normal use QEVO The product has been developed for the use by qualified surgeons to support diagnosis and treatment during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. Further fields of application include ENT, spinal and plastic reconstructive surgery. QEVO ECU The product exerts its function integrated within a surgical microscope using the power supply, the user interface and the monitor of a surgical microscope.

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Instructions for Use QEVO and QEVO ECU

2 Safety notes 2.3 Responsibilities and duties of the operator

2.3 Responsibilities and duties of the operator Operating personnel The product may be operated only by instructed and trained persons. Action

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 simplify access for all operating personnel, order additional copies of the Instructions for Use from ZEISS as required.

u

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

u

Determine the reporting obligations for malfunction and damage and make them known. Notification of the manufacturer and authorities.

u

Provide the necessary protective clothing.

u

Regularly check that the legal regulations applicable in your country with regard to accident prevention and work safety are being complied with.

Safety inspections The safety inspections may only be performed by ZEISS Service. u

High temperatures and pressures during autoclaving may lead to changes in material which can impair image quality. We recommend performing service after reaching 150 sterilization cycles in order to ensure proper functioning and optimal image quality [} 46].

u

Regular checking is necessary to constantly ensure proper functioning and a long service life. For example, within the framework of a service and maintenance contract.

u

Comply with the specified time limits.

u

Carry out checks according to the extent specified.

The safety inspections of the product and the control unit should at least comprise the following points: • Availability of the Instructions for Use • Visual inspection of the product for damage, as well as legibility of the labels • Functional test of the light, the camera, the image quality and the connector on the product. • Leakage current test

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2 Safety notes 2.3 Responsibilities and duties of the operator

Instructions for Use QEVO and QEVO ECU

• Test of protective ground conductor • Functional test of the socket for the product on the connector panel of the control unit. Maintenance and inspection u

In order to constantly ensure proper functioning of the device and reach its expected useful life: Comply with the maintenance and inspection intervals specified in these Instructions for Use.

Modifications to the product Modification of the product is not allowed. This product must not be modified without the manufacturer’s approval. If the product is modified, suitable inspections and tests must be performed to ensure that the product can still be used safely.

2.3.1 Network connection requirements The control unit for the product is permanently installed in the KINEVO 900. The requirements for connecting the KINEVO 900 to a network are applicable here. Action

u

Please read and follow the Instructions for Use for the KINEVO 900 [} 7].

2.3.2 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 of the medical product. In the European Union, the operator must report this serious incident to the competent authority in his/her country.

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Instructions for Use QEVO and QEVO ECU

2 Safety notes 2.4 Measures and duties of the operator

2.4 Measures and duties of the operator Electrical safety Action

u

Do not touch the product if your body is electrostatically charged and the product is not grounded.

u

Please note the information on electromagnetic compatibility (EMC).

u

Live parts are freely accessible in the interior of the product and the control unit. If you remove the housing, you run the risk of electric shock. Never open the housing!

The electrical interconnection conditions demand that the applied parts from other ME devices used within the configuration for endoscopic application must be applied parts of the type BF or CF. Ambient conditions u

Operate the product only within the limits of the prescribed ambient conditions [} 52].

u

Ensure that the installation conditions and operation meet surgical requirements:

• Low vibration • Clean environment • Avoid extreme mechanical stress u

Do not use power-operated products included in the delivery package

• in explosive atmospheres, • at a distance of less than 25 cm from flammable anesthetics or volatile solvents such as alcohol, benzine or similar substances. Symbols and labels u

Note the symbols and labels attached to the product!

Transport

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u

Transport the device over long distances (e.g. relocation, return for repair) only in its original packaging or special return packaging.

u

Please contact your dealer or ZEISS Service for this purpose.

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2 Safety notes 2.5 Electromagnetic compatibility

Instructions for Use QEVO and QEVO ECU

2.5 Electromagnetic compatibility The product is subject to specific requirements with regard to electromagnetic compatibility (EMC). The following factors can cause EMC malfunctions: When the product is used, observe the following EMC precautions regarding the EMC: • Portable and mobile RF communication devices in the vicinity of the product. • Other products which are set up in the vicinity. • Accessories and cables and spare parts that are not specified in these Instructions for Use and not sold by ZEISS as spare parts. Take the following precautionary measures to avoid EMC malfunctions: Procedure

u

Observe the Instructions for Use.

Action

u

Observe the EMC guidelines in the section "Specifications".

u

If you use radios or wireless transmission components: Maintain a minimum distance of 30 cm to all components of the product.

u

If you set up the product in the vicinity of other devices: Check whether normal operation is possible in this arrangement.

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Instructions for Use QEVO and QEVO ECU

3 Product description 3.1 Labeling

3 Product description 3.1 Labeling Function failure due to incorrect operation and wrong storage!

CAUTION!

If the labeling on the product and connector panel of the control unit is not correctly understood or read, the product can be operated and stored incorrectly. u

Make sure that all labeling on the product and connector panel of the control unit is legible.

u

When operating the product, observe all labeling on the product and connector panel of the control unit.

u

Observe all labeling on the packaging for storage and transportation.

3.1.1 Labeling on the product 3.1.1.1 Labeling on the lower surface

1

2

3

4

7

6

5

Figure 1: Product Item

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Symbol

Name

Explanation

1

Intermittent mode

Operating mode: Do not use [} 25] the product in the continuous mode.

2

UDI

UDI labeling

3

Item number

Reference number

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3 Product description 3.1 Labeling

Instructions for Use QEVO and QEVO ECU

Item

Symbol

Name

Explanation

4

CE marking

This medical device is labeled according to Appendix XII of Medical Device Directive 93/42/ EEC.

5

BF applied part

Fulfills the BF conditions for protection against electric shock according to IEC 60601-1.

6

Serial number

-

7

Maintenance interval

Informs about implemented maintenance intervals.

3.1.1.2 Labeling on the connector

1 2

Figure 2: Connector Pos.

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Symbol

Name

Explanation

1

Arrow

Insertion direction on the connector panel of the control unit QEVO ECU

2

Applied part BF

Satisfies the BF conditions in accordance with IEC 60601-1 for protection against electrical shock.

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Instructions for Use QEVO and QEVO ECU

3 Product description 3.1 Labeling

3.1.2 Labeling on the packaging 3.1.2.1 Packaging sign

1

2

3

4

5

7

6

20 8 19 18

9 10

17

11

16

15

13

14

12

Figure 3: Packaging sign Pos.

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Symbol

Name

Explanation

1

Keep away from sunlight

Protect the packaging and packaged contents from heat and solar radiation.

2

Keep dry

Protect the packaging and packaged contents from moisture.

3

Consult Instructions for Use

Read and observe the Instructions for Use.

4

Non-sterile

The product in the packaging is cleaned, but not sterile. Before first use, the product must be completely reprocessed.

5

-

The product may be exclusively used by a physician or another person on behalf of a physician.

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3 Product description 3.1 Labeling

Instructions for Use QEVO and QEVO ECU

Pos.

Name

Explanation

6

Unsuitable for MR

The product may not be operated or stored in an environment in which magnetic resonance occurs.

7

UDI

UDI labeling

8

Ident. No. UDI

Contains specifications on the unambiguous identification of the product.

9

CE label

The medical device is labeled in line with appendix XII of the Medical Device Directive 93/42/ EEC.

10

Endoscope

Type of product

Country of manufacturing

The product is manufactured in Germany.

12

Packing unit

Packaging contains one product.

13

Atmospheric The product may only be transpressure ported and stored at an limitation atmospheric pressure of min. 500 hPa and max. 1060 hPa.

14

Humidity limitation

15

Temperature The product may only be translimit ported and stored at a temperature range of min. -20 °C and max. +60 °C.

16

Serial number

-

Product name

-

11

17

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Symbol

Made in Germany

QEVO

The product may only be transported and stored at an air humidity of min. 10 % and max. 92 % RH.

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Instructions for Use QEVO and QEVO ECU

3 Product description 3.1 Labeling

Pos.

Symbol

Name

Explanation

18

Catalogue number

Reference number

19

Manufacturer

Contains name and address of the manufacturer and the date of manufacture.

20

Intermittent mode

Operating mode: Do not use [} 25] product in continuous operation.

3.1.2.2 Packaging

1

2

3

4

5

6

7

Figure 4: Packaging Pos.

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Symbol

Name

Explanation

1

Indication of Arrows must point upwards when direction for placing the package. transportating and storing the packaging "top"

2

Fragile, handle with care

The packaged contents are fragile.

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3 Product description 3.1 Labeling

Instructions for Use QEVO and QEVO ECU

Pos.

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Symbol

Name

Explanation

3

Keep dry

Protect the packaging and packaged contents from moisture.

4

Humidity limitation

The product may only be transported and stored at an air humidity of min. 10 % and max. 92 % RH.

5

Atmospheric The product may only be transpressure ported and stored at an limitation atmospheric pressure of min. 500 hPa and max. 1060 hPa.

6

Temperature The product may only be translimit ported and stored at a temperature range of min. -20 °C and max. +60 °C.

7

Number of packaging units

Packaging contains one product.

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