ZEISS EXTARO 300 Instructions for Use ver 1.0 Oct 2021

Copyright © Carl Zeiss Suzhou Co., Ltd 2021 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, this user manual may be digitized and archived for internal use. Access to this data by third parties is not permissible and must be prevented. Subject to changes in design and scope of delivery, as well as ongoing technical development.

Registered trademarks EXTARO, Varioskop and VisionGuard are either trademarks or registered trademarks of Carl Zeiss Meditec AG or other companies of the ZEISS group in Germany and other countries. © Carl Zeiss Meditec AG, 2021. All rights reserved.

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Instructions for Use

Table of Contents

Table of Contents Before you read... 5 Name of product ... 5 Scope... 5 Symbols in the manual ... 5 Safety notes ... 6 Target group ... 6 Intended use ... 6 Notes for operation ... 6 Stands and labels ... 8 Stands... 8 Labels ... 8 Controls ... 12 Controls on the microscope ... 12 Controls on the arm and yoke assembly ... 13 Connections and power button of E-box... 14 Description of system options ... 15 LightBoost ... 15 Augmented visualization ... 16 5.2.1 Fluorescence Mode ...16 5.2.2 Orange Color Mode and TrueLight Mode ...19 5.2.3 Green Color Mode ...20 5.2.4 NoGlare Mode ...20 5.2.5 Multispectral Mode ...21

Ergonomics ... 22 5.3.1 Foldable tube ...22 5.3.2 Co-observation tube & straight tube (optional) ...22

Documentation ... 23 5.4.1 Complete Communication package ...23

Asepsis & drapes & drape adapter ... 24 5.5.1 Reusable asepsis sets ...24 5.5.2 Drapes ...25 5.5.3 Drape adapter ...25

iPad holder ... 26 Preparing system for use ... 28 Unpacking and inspection ... 28 6.1.1 Delivery list (basic configuration for mobile version) ...28 6.1.2 Unpacking and inspection steps ...28 000000-2466-133 -1.0-2021-10-20

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Table of Contents

Instructions for Use

Mounting the microscope... 29 6.2.1 Recommended table specification ... 29 6.2.2 Rotation limiter ... 30 6.2.3 Mounting procedures ... 31

Preparing sterility ... 35 6.3.1 Attaching asepsis caps ... 35 6.3.2 Attaching the drapes ... 35

Balancing... 37 Finding ergonomic working position... 38 Adjusting the tube ... 38 Adjusting eyepieces ... 38 Parfocal imaging ... 40 Working with the microscope ... 41 Recording image/video with Mode Control Mode ... 41 Adjusting light intensity ... 41 SpotLight function ... 42 Switching between Augmented Visualization modes ... 42 Cleaning ... 44 Cleaning optical surfaces ... 44 Prevention of fogging ... 44 Cleaning mechanical surfaces ... 44 Maintenance ... 45 Maintenance intervals... 45 Safety check ... 47 Trouble shooting ... 48 Causes of malfunctions and remedies ... 48 Failure of the Mode Control knob ... 49 Failure of the motorized filter wheel (optional) ... 49 Failure of the power socket ... 50 Technical specification ... 51 Electrical data ... 51 Mechanical data ... 52 Optics data ... 53 Documentation package ... 55 Ambient requirements for operation... 55 Ambient requirements for transport and storage ... 56 Wireless communication ... 56 3 / 64

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Instructions for Use

Table of Contents

11.7.1 Wi-Fi router information ...56

Manufacturer’s declaration for electromagnetic compatibility ... 57 11.8.1 Electromagnetic emission ...58 11.8.2 Electromagnetic immunity for ME equipment and ME systems ...58 11.8.3 Use of class A device ...59

Ordering data ... 60 Regulatory information ... 60 Simplified EU declaration of conformity ... 61 Disposal ... 62 List of abbreviations term ... 63

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Before you read

Instructions for Use

Before you read Name of product EXTARO 300 is designated as “device” in this Instructions for Use.

Scope The Instructions for Use apply to EXTARO 300 with the following identification: ▪ ▪

EXTARO 300 (table mount - mobile version) EXTARO 300 (table mount - stationary version)

Symbols in the manual Hazard symbols !

WARNING!

Hazards that can cause fatal or severe injuries if not avoided.

CAUTION!

Hazards that can cause moderately severe injuries if not avoided.

!

NOTE

Hazards that can cause property damages if not avoided.

Information symbols Additional information, not hazards related.

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Safety notesInstructions for Use

Safety notes

Safety notes Target group This user manual is intended for physicians, nurses and other medical staffs who prepare operate or maintain the device after appropriate training. It is the duty of the equipment owner/operator to train and instruct all staff using the system. Installation and service work that is not described in this user manual must only be performed by specialists from ZEISS or staff specially trained for this purpose by ZEISS.

Intended use The surgical microscope is intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures or examinations (except ophthalmic surgeries). It optionally enables handling of light curing dental composite resins and aids in reducing specular light reflections and enhances contrast between red tissue and blood.

!

CAUTION!

Injury to the patient's eye! • The EXTARO 300 must not be used for ophthalmic procedures! • Make sure that no illumination light of the microscope enters the patient's eyes.

!

CAUTION!

Live video images and recorded video sequences, video clips (cut sequences) and single images must not be used for diagnosis purposes. Visualized images may contain variations in shape, contrast and color.

Notes for operation ▪ ▪ ▪ ▪

Observe the legal regulations for accident prevention and occupational health & safety applicable in the country concerned; Use original accessories or accessories approved by Zeiss. Use only original Zeiss parts in maintenance work; The surgical microscope can only be used by properly trained personnel within the scope of its intended use; This equipment must not be modified without the manufacturer's approval. If the equipment is modified after consulting the manufacturer, appropriate examinations and tests must be performed to guarantee the further secure use of the device. The manufacturer is not liable for any damage caused by unauthorized use of the equipment;

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Safety notes ▪

Instructions for Use

▪

Do not place any fluid-filled containers on top of the instrument. Make sure that no fluids will seep into the instrument; Do not cover up the ventilation openings, as it can cause the device to overheat during operation and become damaged; The system will not have light output without plugging the light guide correctly. Always switch off the system before disconnecting it from / connecting it to line power, for cleaning its surface or if it will not be used for a prolonged period of time. Avoid looking directly into the light source, e.g. into the microscope objective lens or into the light guide, in order to prevent damage to the eye. Do not shine lights in anyone's eyes. EXTARO 300 can only be used in professional healthcare facility environments such as physician offices, dental offices, clinics, hospitals (emergency rooms, patient rooms, intensive care and surgical rooms without high-frequency surgical equipment). Additionally, it should be used outside the RF shielded room of medical electrical systems for MRI. Use of EXTARO 300 adjacent to or stacked with other equipment may result in improper operation. If such use case cannot be avoided, the user must verify that the EXTARO 300 and its adjacent equipment are functioning normally before operation. Depending on the type of application, take appropriate precautions to ensure that the surgical procedure or treatment can still be completed even if the full functionality of this microscope (e.g. illumination) is not available. For the purpose of its operation, the equipment has wireless communication function, it includes RF transmitter and receiver, 2.4GHz, Pulse modulation. The equipment is designed compatible with high frequency surgical equipment; the condition includes working or standby in close proximity to high frequency surgical equipment. When using the ZEISS EXTARO 300 with the MORA interface, please check before using the system if the connection between the OPMI head and MORA interface is secure or if there is any movement present. If there is movement, please stop using the system immediately and contact your local ZEISS Service or an authorized partner to fix it. Please check and make sure that the product identification information (i.e. serial number) on the transport boxes are correct before unpacking. Before using the system, please check the rotation range of each axis, reference to chapter 11.2 mechanical data for details. If any abnormality is observed, please stop using the system and contact your local ZEISS Service or an authorized partner. Never release the column till it is fastened firmly in the mounting plate to prevent tipping over. Always keep the device structure within the specified rotation limit range and ensure the arms are over the table surface, make sure that the device won’t tilt or fall down. Hang the E-box stably underneath the mounting plate in order to prevent it falling down. The table shall withstand 4 times the weight of the device configuration, so as to stabilize the system to prevent any tipping motions. The table legs must be fixed to the ground to prevent the device tip over. Only connect to power supply when all the components are installed completely and everything is ready. The patient must wear a strong light protection glass during demonstration in Dentistry or ENT on human body. Pay attention to avoid hitting patient or other objects when moving the OPMI.

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▪ ▪ ▪ ▪

▪

▪

▪ ▪ ▪

▪ ▪

▪ ▪ ▪ ▪

▪ ▪

Instructions for Use

Stands and labels

Stands and labels Stands

Mobile version

Stationary version

Labels #

Symbol

1

2

Designation

Description

Friction adjustment

Adjust the braking force (friction) of the movement axis by turning the friction knob.

Adjust balance of suspension arm

To increase the lifting force of suspension arm: turn the screw in the direction of bigger weight; To decrease the lifting force: turn in the direction of smaller weight.

3

Risk of pinching hand

Fingers may be crushed. Do not touch this area while moving the surgical microscope.

4

Maximum load on suspension arm

The maximum load on the suspension arm must not exceed 8Kg.

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Stands and labels

5

6

Instructions for Use

Input voltage

UDI label

The input voltage at the power socket should be compliant with the specification on this label. 1) YYYY-MM-DD: manufacturing date in the sequence of Year-Month-Day 2) UDI (Unique Device Identification) contents: − − −

(01): company & product code (11): manufacturing date (21): serial number

7

“Observe the Instructions for Use” label

This label tells the user to read the user manual for detailed function of the control

8

Observe disposal regulations

Electrical or electronic devices must not be disposed of as normal domestic waste, see Section 13 for details.

9

Power switch

Power switch that can be pressed to toggles between on/off status

10

Warning of light hazard

11

Distributor information (for North America)

12

Service identification label

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Possibly hazardous optical radiation emitted from this product. To avoid any ocular risk, do not look directly at the light. May be harmful to the eyes. 1) Carl Zeiss Meditec Inc. is responsible for the distribution and complaint handling for EXTARO 300 in the USA and Canada. 2) Rx only: this symbol means the product is only for professional use

The SIP number is a unique identification number assigned to your system for service purpose.

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Instructions for Use

Stands and labels

Manufacturer information Serial number

13

System identification label (for treatment unit only)

Reference number CE mark Authorized representative in the European Community CSA approval MD labelling

14

Tipping warning label

Possibly hazardous from this product. To avoid any risk, ensure the table is stable enough and perform properly in line with the operation guides introduced in this device instruction for user.

Reference number Serial number Manufacturing date in the sequence of Year-Month-Day UDI label for Fluorescence Mode

UDI (Unique Device Identification) contents:

16

Label for ElectroStatic Discharge

The sudden transfer of charge between bodies of differing electrostatic potentials that may produce voltages or currents that could destroy or damage electrical components

17

Lighting symbol on E-BOX

The USB port with lightning symbol is designed only for charging, which shall not be connected to camera control unit.

15

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- (01): company & product code - (11): manufacturing date - (21): serial number - (241): Reference number

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Stands and labels

Instructions for Use

18

Warning label on E-BOX

Do not grip the housing to move the EBOX,otherwise may lead to damages on the housing and Wi-Fi antena.

19

warning of light hazard output

Possibly hazardous optical radiation emitted from here. to avoid any ocular risk, do not look into it.

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Instructions for Use

Controls

Controls Controls on the microscope

Controls on the microscope Item No.

Component name

Item No.

Component name

1

Pupillary distance adjustment

2

Emergency Knob

3

Knob of Magnification Changer (MC)

4

Varioskop 230 for focus adjustment

5

Mode Control knob

6

Securing screw

7

Diopter setting on eyepiece

NOTE

Loosening the securing screw may cause the tube to fall off!

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Controls

Instructions for Use

Controls on the arm and yoke assembly

Controls on the arm and yoke assembly Item No.

Component name

Item No.

Component name Brake of axis 1 for locking the carrier arm

1

Rotation limiter of carrier arm

2

3

Brake of axis 2 for locking the suspension arm

4

Brake of axis 3 for locking the vertical position of suspension arm

5

Brake of axis 4 for locking yoke orientation

6

Brake on yoke for locking swivel angle

7

Brake for locking tilt angle

Screw for adjusting lifting force of suspension arm 13 / 64

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Instructions for Use

Controls

Connections and power button of E-box

Connections on the rear side of E-box Item No.

Component name

Item No.

Component name

1

Earth connection

2

LAN connection for iPad

4

WAN connection for clinic network

6

Camera connection

5

OPMI connection for power supply and signal control USB connection for data storage

7

HDMI connection

8

USB connection for charging

9

WIFI module settings dip switches

10

Power connection

11

Light guide connection

3

Power button on the front side of E-box

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Description of system options

Instructions for Use

Description of system options The availability of features can vary depending on the configuration of the device. For detailed ordering information of all options, please consult your authorized ZEISS partner.

LightBoost LightBoost is used to increase the maximum light output of the illumination lamp by approximately 60%, see illustration below for reference.

! CAUTION!

Protective eyewear to mitigate risk of illumination on the eye During surgery/examination, it’s required that the patient wear a protective eyewear to avoid hazardous illumination light directly entering his/her eye. For details of the eyewear, please contact your authorized ZEISS partner.

To lower the risk of phototoxic injury of the patient’s eye, EXTARO 300 also provides a function called SpotLight that supports the user to control the illuminated-field diameter via the Mode Control knob. For details, please refer to Section 7.3.

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Instructions for Use

Description of system options

Augmented visualization Always bear in mind that all necessary protective measures shall be taken to prevent any potential injuries. !

WARNING!

Risk of irreversible damage to eyesight and even blindness! • During demonstration in dentistry or ENT on human body, patients must wear a strong light protection glass.

5.2.1 Fluorescence Mode Fluorescence Mode is an optional accessory to EXTARO 300 surgical microscope. Intended use: Fluorescence Mode is intended to be used by qualified physicians in dentistry as an aid in the detection of dental caries and as an aid to distinguish composite resin material from natural dentin enamel. It can aid to highlight dental plaque and calculus. When Fluorescence Mode is activated, the SpotLight function will automatically limit the diameter of illuminated field to less than 100 mm in order to prevent direct exposure of the patient’s eye to the violet light. Detection of caries/plaque/calculus (all appear red in Fluorescence Mode) Visual identification of carious lesion enables uninterrupted workflow of excavation. The energy rich blue-violet light (405 nm) of the Fluorescence Mode causes the tooth structure (tooth enamel, dentine) and the metabolites of cariogenic bacteria (porphyrins) to fluoresce. For healthy dental enamel, the fluorescence light has a greenish color with a peak wavelength around 500 nm. By contrast, carious teeth will exhibit extra red fluorescence light with peak wavelengths around 635 nm and 680 nm1,2. The red fluorescence is the emission from porphyrin compounds in oral bacteria associated with the caries. Example images of red and green fluorescence are provided below:

(1) Infected tooth with carious lesion (red)

(2) Continuously controlled excavation

(3) Excavated cavity

Citation:

1) Clinical trial for detection of dental caries using laser-induced fluorescence ratio reference standard, Journal of Biomedical Optics Vol.15(2), 2010. 2) Buchalla W, Attin T, Niedmann Y, Niedmann PD, Lennon AM: Porphyrins are the cause of red fluorescence of carious dentine: Verified by gradient reversed-phase HPLC. Caries Res; 42, 223 (2008). Instructions for use to aid in the detection of dental caries, plaque and calculus 000000-2466-133 -1.0-2021-10-20

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Description of system options

Instructions for Use

Follow the instructions below to properly set the OPMI in Fluorescence Mode: 1

2

3

Short press the Mode Control knob to activate the Fluorescence Mode (for details, see Section 7.4 . The white illumination light will then be turned off and violet light will be turned on.

Adjust the light intensity to 100% by rotating the Mode Control knob. Refer to Section 7.2 for details of how to adjust the light intensity.

Set MC to the magnification factor of 1x which will give the user a balanced performance of image brightness and resolution under Fluorescence Mode.

When Fluorescence Mode is activated, the SpotLight function will automatically limit the diameter of the illuminated field to less than 100 mm, in order to prevent direct exposure of the patient’s eye to the violet light. Conditions for using the Fluorescence Mode are summarized in the table below: Ideal Conditions Magnification 1 factor Parameter

Effect of Variation Increase magnification in order to obtain higher magnification of the image, which may be accompanied by a decrease in brightness. Decrease magnification in order to get a larger field of view, which may be accompanied by an increase in brightness.

Working distance

300 mm

Increase in order to set the ergonomic distance between the dentist and patient if the dentist is tall. Decrease in order to set the ergonomic distance between the dentist and patient if the dentist is short.

Intensity

100 %

Increase in order to obtain brighter image. Decrease in order to make the image darker.

Working outside of these parameters may lead to a darker image in the eyepiece. In this case, the contrast between red and green will be low and a detection of porphyrins (red fluorescence) may be difficult. If the image appears too dark, try adjusting the three parameters toward the ideal conditions above until a satisfactorily bright image is achieved. If adjustments do not improve the quality of the image, external light may be interfering with image quality. If the image appears appropriately bright, but has reduced contrast or a slightly orange image, this may be the problem. Strong background light cast on the tooth from a large oblique angle is most likely to interfere. In order to improve image quality, reduce any suspected sources of background light such as sunlight from windows, ceiling lights, or examination lights. 17 / 64

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Instructions for Use

Description of system options

If the image cannot be remedied, switch back to the white light (standard mode) of the device and continue the procedure conventionally. ! WARNING!

The Fluorescence Mode uses color to provide information that may aid in the detection/ location of caries/plaque/calculus by red color of metabolites of cariogenic bacteria. It is not suitable for use by persons who are red/green color blind. This device is not to be used for the diagnosis of caries; the definitive diagnosis of caries should be performed using the standard of care (e.g. visual/tactile examination and radiographic evaluation if necessary). The device is not to be used to guide tooth debridement during treatment of dental caries.

Recommended procedure for detecting caries The following procedure steps are recommended for the detection of caries: ▪ Perform professional teeth cleaning. ▪ Remove polishing paste using the air/ water spray. ▪ Dry the teeth. ▪ Select ideal parameters for Fluorescence Mode: see the parameter table in the previous page. ▪ Observe teeth through eyepieces directly or with the help of dental mirror. Green signal: tooth enamel, dentine. Red signal: metabolites of cariogenic bacteria that may aid in the detection of dental caries. ▪ For patient information purposes, a video image of optional integrated camera can be displayed on a video screen. ▪ After viewing locations of potential caries in Fluorescence Mode, definitive diagnosis of caries should be performed using visual and tactile examination, with radiographic evaluation if necessary. Artificial substances that show a similar auto-fluorescence signal than porphyrins could in principle be present in the oral cavity. Before caries detection with the Fluorescence Mode, it is therefore recommended to perform a professional tooth cleaning which removes artificial substances from the teeth. Similarly, the professional tooth cleaning removes plaque and therefore helps to avoid false positives on the tooth’s surface. Tartar, however, might not be completely removed by the tooth cleaning. Tartar and caries can be distinguished in the white light image since only tartar is an additional structure on the tooth’s surface. Generally, caries, plaque, tartar and artificial substances can be distinguished through visual and tactile inspection under white light illumination. If unsure of the status of tooth’s surface when viewing under fluorescence, switch the device to white light illumination and continue examination using conventional methods.

Troubleshooting summary

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Description of system options

Instructions for Use

Fault

Cause

Rectification

Image too dark

Inappropriate parameter setting of the working conditions (mag. factor, working distance and intensity)

Adjust values of the parameters toward the base recommendation aforementioned.

Bright image but poor contrast

Strong background light

Orange tint

Strong background light

Reduce any suspected sources of background light (e.g. sunlight from windows, ceiling lights, or examination lights). Reduce any suspected sources of background light (e.g. sunlight from windows, ceiling lights, or examination lights).

! CAUTION!

Strong background light (i.e. room light) may have an impact on the appearance of colors being observed in Fluorescence Mode. Sources of strong background light can be dental examination light, direct sunlight or intense ceiling lights. In case you experience reduced contrast or a slightly orange image during use of the Fluorescence Mode, remove examination light, dim ceiling light or block direct sunlight.

Composite detection For most dental composite resins, the contrast between composite and healthy tooth are greater in Fluorescence Mode than in white light mode (Dental Materials Journal 2015; 34(6): 754–765, Photodiagnosis and Photodynamic Therapy 13 (2016) 114–119). This contrast enhancement leads to a more reliable identification of tooth-colored composite resins (Clin Oral Invest (2017) 21:347- 355).

Composite resin under White Light Mode

Composite resin under Fluorescence Mode

5.2.2 Orange Color Mode and TrueLight Mode Orange Color Mode and TrueLight Mode are both optional accessories to EXTARO 300 surgical microscope. Both Orange Color Mode and TrueLight Mode fall in the category of Delay Curing Mode which prevents the premature polymerization of widely used contemporary light curing composite resins during the modeling process under the microscope.

In contrast to the Orange Color Mode, the TrueLight Mode supports you to identify relevant dental 19 / 64

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