Zeiss EXTARO 300 User manual

ZEISS EXTARO 300
Instructions for Use

Copyright
© Carl Zeiss Suzhou Co., Ltd 2018
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.
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, 2018. All rights reserved.

Instructions for Use Table of contents
3 / 65 305935-9900-000–1.3 –2020-08-25-for USA
Table of contents
Table of contents................................................................................................................3
Before you read........................................................................................................6
Name of product....................................................................................................................................6
Scope .....................................................................................................................................................6
Symbols in the manual...........................................................................................................................6
Safety notes ...........................................................................................................7
Target group ..........................................................................................................................................7
Intended use..........................................................................................................................................7
Notes for operation ...............................................................................................................................7
Stands and labels...................................................................................................9
Stands/mounts ......................................................................................................................................9
Labels...................................................................................................................................................10
Controls ................................................................................................................12
Controls on the microscope .................................................................................................................12
Controls on the yoke and stand ...........................................................................................................13
Description of system options............................................................................16
LightBoost............................................................................................................................................16
Augmented visualization......................................................................................................................17
5.2.1 Multispectral Mode................................................................................................................... 17
5.2.2 Green Color Mode..................................................................................................................... 17
5.2.3 NoGlare Mode........................................................................................................................... 17
Documentation....................................................................................................................................18
5.3.1 Essential Communication package............................................................................................ 18
5.3.2 Complete Communication ........................................................................................................ 19
5.3.3 External camera adapter (photo adapter) ................................................................................ 20
Handgrips.............................................................................................................................................20
External focus ......................................................................................................................................21
Laser micromanipulator adapter..........................................................................................................21
Asepsis & drapes..................................................................................................................................22
5.7.1 Reusable asepsis sets ................................................................................................................ 22
5.7.2 Drapes ....................................................................................................................................... 23
Docking station for iPad.......................................................................................................................23
Preparing system for use....................................................................................24
Relocating the system..........................................................................................................................24
Connecting the system.........................................................................................................................25
6.2.1 Connecting the cables............................................................................................................... 25
6.2.2 Connecting cable relief kit......................................................................................................... 25

Instructions for Use Table of contents
4 / 65 305935-9900-000–1.3 –2020-08-25-for USA
Balancing .............................................................................................................................................26
6.3.1 Adjusting balance of the yoke................................................................................................... 26
6.3.2 Balancing the suspension arm................................................................................................... 31
Preparing sterility ................................................................................................................................32
6.4.1 Attaching asepsis caps............................................................................................................... 32
6.4.2 Attaching the drapes................................................................................................................. 32
Finding ergonomic working position ....................................................................................................33
Adjusting eyepieces .............................................................................................................................34
Parfocal imaging ..................................................................................................................................35
Working with the microscope .................................................................................36
Using the camera .................................................................................................................................36
7.1.1 Recording image/video with the Mode Control knob .............................................................. 36
7.1.2 Recording image/video with the remote controller ................................................................. 36
7.1.3 Adjusting white balance of camera........................................................................................... 37
Adjusting light intensity .......................................................................................................................38
SpotLight function................................................................................................................................38
Switching between Augmented Visualization modes...........................................................................39
Setting the microscope to parking position..........................................................................................39
Cleaning and disinfection ...................................................................................40
Cleaning...............................................................................................................................................40
8.1.1 Cleaning optical surfaces........................................................................................................... 40
8.1.2 Prevention of fogging................................................................................................................ 40
8.1.3 Cleaning mechanical surfaces ................................................................................................... 40
Disinfection..........................................................................................................................................41
Maintenance ........................................................................................................42
Maintenance intervals .........................................................................................................................42
Safety check.........................................................................................................................................44
Trouble shooting .................................................................................................45
Causes of malfunctions and remedies..................................................................................................45
Failure of the Mode Control knob ........................................................................................................46
Failure of the motorized filter wheel (optional) ...................................................................................46
Technical specification........................................................................................47
Electrical data ......................................................................................................................................47
Mechanical data...................................................................................................................................48
11.2.1 General information.................................................................................................................. 48
11.2.2 Weight information................................................................................................................... 48
11.2.3 Definition of Axis 1~Axis 6......................................................................................................... 49
11.2.4 System dimensions.................................................................................................................... 50

Table of contents Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 5 / 65
Optics data...........................................................................................................................................52
Documentation package ......................................................................................................................53
Ambient requirements for operation...................................................................................................54
Ambient requirements for transport and storage ................................................................................54
Wireless communication......................................................................................................................55
11.7.1 Wi-Fi router information........................................................................................................... 55
11.7.2 Statement of Class B digital device (Part 15 of the FCC Rules) ................................................. 55
11.7.3 Conformity of FFC Rules............................................................................................................ 55
Guidelines and manufacturer’s declaration for electromagnetic compatibility ....................................56
11.8.1 Electromagnetic emission ......................................................................................................... 57
11.8.2 Electromagnetic immunity for ME equipment and ME systems .............................................. 57
11.8.3 Electromagnetic immunity for non-life-supporting ME equipment and ME systems .............. 59
11.8.4 Recommended safety distances between portable and mobile RF communication equipment
and the EXTARO 300 ................................................................................................................. 60
11.8.5 Use of class A device ................................................................................................................. 60
Ordering data.......................................................................................................................................61
Regulatory information........................................................................................................................61
Simplified EU declaration of conformity ...........................................................62
Disposal ................................................................................................................ 63
List of abbreviations term...................................................................................64

Instructions for Use Before you read
6 / 65 305935-9900-000–1.3 –2020-08-25-for USA
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 (floor stand)
▪EXTARO 300 (wall mount)
▪EXTARO 300 (ceiling mount)
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 notes Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 7 / 65
Safety notes
Target group
This user manual is intended for physicians, nurses and other medical staff 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;
▪Risk of injury from rolling of the floor stand! Always push rather than pull the microscope to
move it. Lock the casters during operation.
▪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;
!
!

Instructions for Use Safety notes
8 / 65 305935-9900-000–1.3 –2020-08-25-for USA
▪Before an extended period of non-use, remove the battery from the remote control;
▪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, ENT 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.
▪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.

Stands and labels Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 9 / 65
Stands and labels
Stands/mounts
Floor stand
Ceiling mount
Wall mount

Instructions for Use Stands and labels
10 / 65 305935-9900-000–1.3 –2020-08-25-for USA
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 14 kg.
5
Maximum weight
The maximum weight of EXTARO 300 (floor
stand) is 195 kg
6
Input voltage
The input voltage at the power socket should
be compliant with the specification on this
label.
7
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
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

Stands and labels Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 11 / 65
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.
13
System
identification
label
Manufacturer information
Serial number
Reference number
Manufacturing Date in the
sequence of Year-Month-
Date
CE mark
Authorized representative in
the European Community
CSA approval
Sign for Medical Device
14
FCC Conformity
label
FCC Declaration of Conformity

Instructions for Use Controls
12 / 65 305935-9900-000–1.3 –2020-08-25-for USA
15
Transport
position
Always hold and push the column at the
indicated point for transportation.
16
“Observe the
Instructions for
Use” label
This label tells the user to read the user
manual for detailed function of the control
Controls
Controls on the microscope
Mode Control knob
Varioskop 230 for focus
adjustment
Knob of Magnification
Changer

Controls Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 13 / 65
NOTE
Loosening the securing screw may cause the tube to fall off!
Controls on the yoke and stand
•For the detailed definition of all the axes (Axis 1 ~ Axis 6) on the suspension system and
yoke, please refer to Section 11.2.
•The name ‘braking knob’ and ‘friction knob’ are used interchangeably in this
document.
Pupillary distance adjustment
Diopter setting on eyepiece
Emergency Knob
Securing screw
Adjustment knob on external
focus (optional)

Instructions for Use Controls
14 / 65 305935-9900-000–1.3 –2020-08-25-for USA
Brakes
Brake of Axis 1 for locking the
carrier arm
Brake of Axis 2 for locking
the suspension arm
Brake of Axis 3 for locking
the vertical position of
suspension arm
Brake of Axis 4 for locking
yoke orientation
Brake of Axis 5 for locking
swivel angle
Brake of Axis 6 for locking
tilt angle
Balancing
Knob and crank for adjusting
balance of Axis 6
Knob and crank for
adjusting balance of Axis 5
Knob for adjusting the
balance of suspension arm
Following pictures show how the crank on the yoke can be unfolded.

Controls Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 15 / 65
On/Off
Power on/off switch
Connections (USB, HDMI, LAN, Power)
Power inlet socket
Strain relief device to prevent
inadvertent cable unplugging
Video interface and Ethernet
connections
1
2
3

Instructions for Use Description of system options
16 / 65 305935-9900-000–1.3 –2020-08-25-for USA
Description of system options
LightBoost
LightBoost is used to increase the light output of the 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 further lower the risk of illumination light, EXTARO 300 also provides a function called
SpotLight that allows the user to control the illuminated-field diameter via the Mode
Control knob. For details, please see the Section 7.3.
!

Description of system options Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 17 / 65
Augmented visualization
5.2.1 Multispectral Mode
The Multispectral Mode is used to enhance contrast between tissue and vasculature.
Tissue image under white light
Tissue image under Multispectral Mode
5.2.2 Green Color Mode
The Green Color Mode is used to enhance contrast between blood and tissue.
Tissue image under white light
Tissue image under Green Color Mode
5.2.3 NoGlare Mode
The NoGlare Mode aids in reducing specular light reflections from the surface and make sub-surface
information more visible.

Instructions for Use Description of system options
18 / 65 305935-9900-000–1.3 –2020-08-25-for USA
Documentation
Three optional solutions are available for EXTARO 300 in terms of image acquisition and video
recording.
5.3.1 Essential Communication package
Main features:
•Integrated HD (1080p) camera
•Video interface
- HDMI output to monitor
- USB port for image & video recording (e.g. with a USB disk)
•Trigger with the mode control knob on microscope or with remote control
•It is recommended that the capacity of USB disk not exceed 256GB.
•We recommend the user to use the “SD formatter” software (freely downloadable from
https://www.sdcard.org/downloads/formatter_4/index.html) to format their USB disk
before using it on the EXTARO 300 system, otherwise the USB disk may not work
properly for image and video storage.

Description of system options Instructions for Use
305935-9900-000–1.3 –2020-08-25-for USA 19 / 65
5.3.2 Complete Communication
Main features:
•Integrated HD (1080p) camera
•Video interface
- HDMI output to monitor
- USB port for image & video recording (e.g. with a USB disk)
•Trigger with the mode control knob on microscope or with remote control
•Network interface (including wireless & wired Ethernet connection)
•ZEISS Connect (iPad app) for
- Camera control including smart recording
- Chair side patient consultation
- Media asset management
- Essential adjusting of images and video
The Connect app is available for download in the Apple app store. For more details please refer
to separate user manual of the Connect app.

Instructions for Use Description of system options
20 / 65 305935-9900-000–1.3 –2020-08-25-for USA
5.3.3 External camera adapter (photo adapter)
EXTARO 300 surgical microscope can be equipped with external camera adapter for users to record
images and videos by his/her own camera. Note that the user should also buy a third-party adapter to
connect the camera with the photo adapter.
Please refer to the product datasheet of EXTARO 300 or consult your authorized ZEISS partner for
ordering information of the external camera adapter.
•The T2 mount is not part of the external camera adapter. User should prepare the
T2 mount according to the model of his/her external camera.
•A beam splitter will be needed to attach the external camera adapter.
Handgrips
EXTARO 300 can be equipped with an adjustable handgrip which allows the user to achieve ergonomic
handling of the OPMI. Alternatively, a compact T-shaped handgrip is also available.
Adjustable handgrip (optional)
T-shaped handgrip (optional)
As depicted above, the adjustable handgrip can be oriented to the desired ergonomic
position through the following procedure:
•Pull the handgrip outward to make it freely rotatable about its lateral axis.
•Rotate the handgrip to an ergonomic angle that best suits the operation.
•Release the handgrip to fix its orientation.
Camera
T2 mount
External camera
adapter