Zeiss EXTARO 300 User manual

ZEISS EXTARO 300
Instructions for Use

Copyright
© Carl Zeiss Suzhou Co., Ltd 2017
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, 2017. All rights reserved.
1 / 59 305935-3500-000 – 2.1 – 2017-12-15

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
Yoke .........................................................................................................................................
8
Labels .......................................................................................................................................
9
Controls........................................................................................................
11
Controls on the microscope ..................................................................................................
11
Controls on the yoke and stand............................................................................................
12
Description of system options......................................................................
14
LightBoost.............................................................................................................................
14
Augmented visualization.......................................................................................................
14
5.2.1 Fluorescence Mode ...................................................................................................
14
5.2.2 Orange Color Mode and TrueLight Mode ..................................................................
15
5.2.3 Green Color Mode ....................................................................................................
16
5.2.4 NoGlare Mode ..........................................................................................................
16
Ergonomics ...........................................................................................................................
17
5.3.1 Foldable tube ............................................................................................................
17
5.3.2 MORA interface ........................................................................................................1
7
Documentation .....................................................................................................................
18
5.4.1 Essential Communication package.............................................................................
18
5.4.2 Complete Communication.........................................................................................
19
5.4.3 External camera adapter (photo adapter)...................................................................
20
Asepsis & drapes ...................................................................................................................
21
5.5.1 Reusable asepsis sets.................................................................................................
21
5.5.2 Drape adapter...........................................................................................................
21
Docking station for iPad .......................................................................................................
22
Lens protection cover............................................................................................................
22
Preparing system for use .............................................................................
23
Relocating the system ...........................................................................................................
23
Connecting the system..........................................................................................................
24
6.2.1 Connecting the cables...............................................................................................
24
6.2.2 Connecting cable relief kit .........................................................................................
24
305935-3500-000 – 2.1 – 2017-12-15 2 / 59

Table of contents Instructions for Use
Preparing sterility.................................................................................................................. 25
6.3.1 Attaching asepsis caps ..............................................................................................
25
6.3.2 Attaching the drapes.................................................................................................
25
Using the lens protection cover ............................................................................................
26
Balancing...............................................................................................................................
27
Setting lowest position of microscope for safety .................................................................
28
Finding ergonomic working position ....................................................................................
28
Adjusting the tube ................................................................................................................
28
Adjusting eyepieces ..............................................................................................................
29
Parfocal imaging ...................................................................................................................
30
Working with the microscope......................................................................
31
Using the camera ..................................................................................................................
31
7.1.1 Recording image/video with the Mode Control knob.................................................
31
7.1.2 Recording image/video with the remote controller ....................................................
31
7.1.3 Adjusting white balance of camera............................................................................
32
Adjusting light intensity ........................................................................................................
33
SpotLight function ................................................................................................................
33
Switching between Augmented Visualization modes...........................................................
34
Setting the microscope to parking position..........................................................................
35
Cleaning and disinfection.............................................................................
36
Cleaning ................................................................................................................................
36
8.1.1 Cleaning optical surfaces...........................................................................................
36
8.1.2 Prevention of fogging................................................................................................
36
8.1.3 Cleaning mechanical surfaces ....................................................................................
36
Disinfection ...........................................................................................................................
37
Maintenance ................................................................................................
38
Maintenance intervals...........................................................................................................
38
Safety check ..........................................................................................................................
40
Trouble shooting..........................................................................................
41
Causes of malfunctions and remedies...................................................................................
41
Failure of the Mode Control knob.........................................................................................
42
Failure of the motorized filter wheel (optional)....................................................................
42
Technical specification .................................................................................
43
Electrical data .......................................................................................................................
43
Mechanical data....................................................................................................................
44
Optics data............................................................................................................................
46
Documentation package .......................................................................................................
47
Ambient requirements for operation ....................................................................................
48
Ambient requirements for transport and storage ................................................................
48
Wireless communication .......................................................................................................
48
11.7.1 Wi-Fi router information............................................................................................
48
11.7.2 Statement of Class B digital device (Part 15 of the FCC Rules) ....................................
48
3 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions for Use Table of contents
11.7.3 Conformity of FFC Rules ............................................................................................49
Guidelines and manufacturer’s declaration for electromagnetic compatibility ....................
50
11.8.1 Electromagnetic emission ..........................................................................................
51
11.8.2 Electromagnetic immunity for ME equipment and ME systems...................................
51
11.8.3 Electromagnetic immunity for non-life-supporting ME equipment and ME systems ....
52
11.8.4
Recommended safety distances between portable and mobile RF communication
equipment and the EXTARO 300..............................................................................................
54
11.8.5 Use of class A device .................................................................................................
54
Ordering data........................................................................................................................
55
Regulatory information .........................................................................................................
55
Simplified EU declaration of conformity ......................................................
56
Disposal........................................................................................................
57
List of abbreviations term ............................................................................
58
305935-3500-000 – 2.1 – 2017-12-15 4 / 59

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 (floor stand)
EXTARO 300 (wall mount)
EXTARO 300 (ceiling mount)
EXTARO 300 (floor 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.
!
!
5 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions 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 dental 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.
Note: EXTARO 300 can be only used in dental application currently.
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;
!
!
305935-3500-000 – 2.1 – 2017-12-15 6 / 59

Safety notes Instructions for Use
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;
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, 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.
7 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions for Use Stands and labels
Stands and labels
Stands
Floor stand with short suspension arm
Floor mount with long suspension arm
Wall mount with long suspension arm
Ceiling mount with long suspension arm
Yoke
Angled (120°) yoke Straight yoke
The straight yoke can only be used in combination with a MORA interface.
305935-3500-000 – 2.1 – 2017-12-15 8 / 59

Stands and labels Instructions for Use
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 7.5 kg.
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.
9 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions for Use Stands and labels
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
CE mark
Authorized representative in
the European Community
CSA approval
14
FCC Conformity
label FCC Declaration of Conformity
15
Transport
position Always hold and push the column at the
indicated point for transportation.
305935-3500-000 – 2.1 – 2017-12-15 10 / 59

Controls Instructions for Use
Controls
Controls on the microscope
NOTE Loosening the securing screw may cause the tube to fall off!
Mode Control knob Varioskop 230 for focus
adjustment
Knob of Magnification
Changer
Pupillary distance adjustment Diopter setting on eyepiece Emergency Knob
Securing screw
11 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions for Use Controls
Controls on the yoke and stand
Brakes
Brake of Axis 1 for locking the
carrier arm
Brake of Axis 1 of wall
mount is on wall adapter
Brake of Axis 2 for locking the
suspension arm
Brake for setting the lowest
position of suspension arm
Brake of Axis 3 for locking the
vertical position of suspension
arm
Brake of Axis 4 for locking yoke
orientation
Brake on 120°yoke for locking
swivel angle
Brake for locking tilt angle
305935-3500-000 – 2.1 – 2017-12-15 12 / 59

Controls Instructions for Use
Balancing On/Off
Screw for adjusting lifting force
of suspension arm 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
For wall and ceiling mount, the cables (Power, Ethernet and HDMI) are internally routed from
within the system to the ports on the wall, therefore no power socket, Ethernet or HDMI port is
offered on the carrier arm for cable connection by the user.
13 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions for Use Description of system options
Description of system options
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.
Augmented visualization
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 as an aid in the detection and diagnosis 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.
To lower the risk of phototoxic injury of the patient’s eye,
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 refer to Section 7.3.
When Fluorescence Mode is activated, the SpotLight function will automatically limit the
illuminated-field diameter to less than 100
mm in order to prevent direct exposure of the
patient’s eye to the violet light.
!
305935-3500-000 – 2.1 – 2017-12-15 14 / 59

Description of system options Instructions for Use
Detection of caries/plaque/calculus (all appear red in Fluorescence Mode)
Visual identification of carious lesion enables uninterrupted workflow of excavation.
(1) Infected tooth with carious
lesion (red)
(2) Continuously controlled
excavation
(3) Excavated cavity
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
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 allows 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.
White Light Mode
Orange Color Mode
TrueLight Mode
15 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions for Use Description of system options
5.2.3 Green Color Mode
The Green Color Mode is use to enhance image contrast between blood and tissue so that they can be
better distinguished.
Blood strain in White Light Mode
Blood stain in Green Color Mode
5.2.4 NoGlare Mode
By effectively suppressing the obtrusive light reflections from the tooth surface, this mode allows to
precisely analyze the color shades of the teeth. The elimination of glare helps very much when true
color has to be determined and compared.
Case 1: White Light Mode
Case 1: NoGlare Mode
Case 2: White Light Mode
Case 2: NoGlare Mode
All the above clinical images were recorded by camera. The visual impression through
the eyepiece might be different from the representation displayed in this manual.
305935-3500-000 – 2.1 – 2017-12-15 16 / 59

Description of system options Instructions for Use
Ergonomics
5.3.1 Foldable tube
Foldable tube is used to satisfy the needs of users with different heights and with different postures. It
has two axles so that the tube can be both folded and straightened.
Folded
Stretch out
5.3.2 MORA interface
The MORA interface increases the mobility of the OPMI (operation microscope) about its lateral tilt axis,
without changing the user's upright, ergonomic seated posture.
MORA installed on OPMI
Locking knob on MORA
Securing screw on MORA
OPMI leans to the right
OPMI leans to the left
17 / 59 305935-3500-000 – 2.1 – 2017-12-15

Instructions for Use Description of system options
Documentation
Three optional documentation packages are available for EXTARO 300 in terms of image acquisition
and video recording.
5.4.1 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 from 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.
305935-3500-000 – 2.1 – 2017-12-15 18 / 59

Description of system options Instructions for Use
5.4.2 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 from 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.
19 / 59 305935-3500-000 – 2.1 – 2017-12-15