Zeiss EXTARO 300 User manual

ZEISS EXTARO 300
Instructions for Use

1 / 65 000000-2466-133 -1.1-2022-06-22 for USA
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.

Instructions for Use Table of Contents
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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............................................................................................................ 21
5.3.1 Foldable tube....................................................................................................................................21
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.............................................................................27
Unpacking and inspection...................................................................................... 27
6.1.1 Delivery list (basic configuration).......................................................................................................27
6.1.2 Unpacking and inspection steps........................................................................................................27

Table of Contents Instructions for Use
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Mounting the microscope.......................................................................................28
6.2.1 Recommended table specification .................................................................................................... 28
6.2.2 Rotation limiter................................................................................................................................. 29
6.2.3 Mounting procedures.......................................................................................................................30
Preparing sterility....................................................................................................34
6.3.1 Attaching asepsis caps......................................................................................................................34
6.3.2 Attaching the drapes ........................................................................................................................34
Balancing................................................................................................................36
Finding ergonomic working position.......................................................................37
Adjusting the tube..................................................................................................37
Adjusting eyepieces................................................................................................37
Parfocal imaging.....................................................................................................39
Working with the microscope .....................................................................40
Recording image/video with Mode Control Mode ..................................................40
Adjusting light intensity ..........................................................................................40
SpotLight function..................................................................................................41
Switching between Augmented Visualization modes..............................................41
Cleaning and disinfection ...................................... Error! Bookmark not defined.
Cleaning...................................................................Error! Bookmark not defined.
8.1.1 Cleaning optical surfaces ..................................................................................................................43
8.1.2 Prevention of fogging.......................................................................................................................43
8.1.3 Cleaning mechanical surfaces ...........................................................................................................43
Disinfection ..............................................................Error! Bookmark not defined.
Maintenance ...............................................................................................44
Maintenance intervals.............................................................................................44
Safety check ...........................................................................................................46
Trouble shooting.........................................................................................47
Causes of malfunctions and remedies.....................................................................47
Failure of the Mode Control knob...........................................................................48
Failure of the motorized filter wheel (optional) .......................................................48
Failure of the power socket ....................................................................................49
Technical specification ................................................................................50
Electrical data.........................................................................................................50
Mechanical data.....................................................................................................51
Optics data.............................................................................................................52
Documentation package.........................................................................................54
Ambient requirements for operation.......................................................................54

Instructions for Use Table of Contents
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Ambient requirements for transport and storage ................................................... 55
Wireless communication ........................................................................................ 55
11.7.1Wi-Fi router information ...................................................................................................................55
11.7.2Statement of Class B digital device (Part 15 of the FCC Rules) ...........................................................55
11.7.3Conformity of FCC Rules ...................................................................................................................56
Guidelines and manufacturer’s declaration for electromagnetic compatibility ........ 57
11.8.1Electromagnetic emission..................................................................................................................58
11.8.2Electromagnetic immunity for ME equipment and ME systems .........................................................58
11.8.3Electromagnetic immunity for non-life-supporting ME equipment and ME systemsError! Bookmark
not defined.
11.8.4Recommended safety distances between portable and mobile RF communication equipment and the
EXTARO 300 .................................................................................................Error! Bookmark not defined.
11.8.5Use of class A device.........................................................................................................................59
Ordering data ........................................................................................................ 61
Regulatory information .......................................................................................... 61
Simplified EU declaration of conformity ......................................................62
Disposal ......................................................................................................63
List of abbreviations term ...........................................................................64

Before you read Instructions for Use
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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.
!
!

Safety notesInstructions for Use Safety notes
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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
EXTARO 300 is a surgical microscope intended for the illumination and magnification of the surgical
area during surgical procedures (except ophthalmic surgeries).
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;
▪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;
!
!

Safety notes Instructions for Use
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▪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.

Instructions for Use Stands and labels
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Stands and labels
Stands
Mobile version
Stationary version
Labels
#
Symbol
Designation
Description
1
Friction
adjustment
Adjust the braking force (friction) of the
movement axis by turning the friction knob.
2
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.

Stands and labels Instructions for Use
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5
Input voltage
The input voltage at the power socket should
be compliant with the specification on this
label.
6
UDI 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
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.
11
Distributor
information (for
North America)
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
12
Service
identification
label
The SIP number is a unique identification
number assigned to your system for service
purpose.

Instructions for Use Stands and labels
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13
FCC Conformity
label
FCC Declaration of Conformity
14
System
identification
label (for
treatment unit
only)
Manufacturer information
Serial number
Reference number
CE mark
Authorized representative in
the European Community
CSA approval
MD labelling
15
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.
16
UDI label for
Fluorescence
Mode
Reference number
Serial number
Manufacturing date in the
sequence of Year-Month-Day
UDI (Unique Device Identification) contents:
- (01): company & product code
- (11): manufacturing date
- (21): serial number
- (241): Reference number
17
Label for Electro-
Static 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

Stands and labels Instructions for Use
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18
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.

Instructions for Use Controls
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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!

Controls Instructions for Use
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Controls on the arm and yoke assembly
Controls on the arm and yoke assembly
Item No.
Component name
Item No.
Component name
1
Rotation limiter of carrier arm
2
Brake of axis 1 for locking the
carrier arm
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

Instructions for Use Controls
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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
3
OPMI connection for power supply
and signal control
4
WAN connection for clinic network
5
USB connection for data storage
6
Camera connection
7
HDMI connection
8
USB connection for charging
9
WIFI module settings dip switches
10
Power connection
11
Light guide connection
Power button on the front side of E-box

Description of system options Instructions for Use
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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.
!

Instructions for Use Description of system options
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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.
Indication for use
The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries.
Visual identification of suspected carious lesions
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:
Suspected tooth with carious lesion (red) that
should be confirmed through clinical
examination
Same area observed after caries
removal
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
Follow the instructions below to properly set the OPMI in Fluorescence Mode:
!

Description of system options Instructions for Use
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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:
Parameter
Ideal
Conditions
Effect of Variation
Magnification
factor
1
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.
If the image cannot be remedied, switch back to the white light (standard mode) of the device and
1
2
3

Instructions for Use Description of system options
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continue the procedure conventionally.
WARNING!
The Fluorescence Mode uses color to provide information that may aid in
the detection/ location of caries 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
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.
!

Description of system options Instructions for Use
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Fault
Cause
Rectification
Bright image but
poor contrast
Strong background light
Reduce any suspected sources of
background light (e.g. sunlight from
windows, ceiling lights, or
examination lights).
Orange tint
Strong background light
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
tissues in a more natural, white-light setting. For most common composite resins with typical
camphorquinone-amine based photoinitiating systems, the TrueLight Mode extends the working time
by a factor of 2 compared to the White Light Mode.
!