Zeiss AT 030 Operator's manual

AT 030
Applanation tonometer
Documentation set

Copyright
©2020, Carl Zeiss Meditec AG, Jena
Trademarks
All trademarks mentioned in this document are the property of
their respective owners.

319300-9120-000-Inhalt0-GB-240320
Contents
Instruction for use
AT 030 Applanation tonometer
[319300-9120-000-GA-GB-240320]
Instructions for use and disinfection
of tonometer measuring prisms
[319300-9231-000-AddGA01-GB-240320]
1
2

319300-9120-000-Inhalt1-GB
Contents
Instruction for use
AT 030 Applanation tonometer
[319300-9120-000-GA-GB-240320]
1

AT 030
Applanation tonometer
Instruction for use

Instruction for use Contents
AT 030
319300-9120-000-GA-GB-240320 3 / 60
Contents
1 Notes on the instructions for use ............................................................... 5
1.1 Product name .................................................................................................................... 5
1.2 Scope of application .......................................................................................................... 5
1.3 Purpose and storage of the documentation ...................................................................... 5
1.4 Questions and comments .................................................................................................. 5
1.5 Conventions in this document ........................................................................................... 5
1.5.1 Conventions in all text areas.......................................................................................................... 5
1.5.2 Conventions in a course of action.................................................................................................. 6
1.6 Applicable documents ....................................................................................................... 6
2 Safety notes ............................................................................................... 7
2.1 Intended user profile ......................................................................................................... 7
2.2 Area of use ........................................................................................................................ 7
2.2.1 Indication for use .......................................................................................................................... 7
2.3 Responsibilities and duties of the operator ....................................................................... 7
2.3.1 Messages to manufacturer and authorities .................................................................................... 8
2.4 Measures and duties of the operator................................................................................. 8
2.5 Maintenance measures...................................................................................................... 9
3 Description of the device............................................................................ 11
3.1 Package check list ............................................................................................................. 11
3.2 Device marking ................................................................................................................. 11
3.3 Structure of the device ...................................................................................................... 12
3.4 Functional description ....................................................................................................... 13
4 Installation ................................................................................................. 15
4.1 Installation safety .............................................................................................................. 15
4.2 General information .......................................................................................................... 15
4.3 Mounting the device on SL 800 slit lamp using the swivel-mounted tonometer holder on
the stereomicroscope or Fundus VarioView ...................................................................... 16
4.4 Mounting the device to the SL 120, SL 130 and SL 220 slit lamps using the swivel-
mounted tonometer holder behind the stereomicroscope................................................. 18
4.5 Mounting the device on SL 120, SL 130, SL 220, and ZEISS VISULAS laser slit lamps
using the fixed tonometer holder ...................................................................................... 20
5 Daily startup............................................................................................... 23
5.1 Preparation safety ............................................................................................................. 23
5.2 Measuring spherical corneal surfaces ................................................................................ 24

Contents Instruction for use
AT 030
4 / 60 319300-9120-000-GA-GB-240320
5.3 Measuring toric cornea surfaces........................................................................................ 24
5.4 Preparing for measurement............................................................................................... 24
5.5 Measurement with AT 030 ................................................................................................ 26
5.6 Conversion table for tonometer readings .......................................................................... 28
6 Cleaning and disinfection ........................................................................... 31
6.1 Safety when cleaning and disinfecting the device ............................................................. 31
6.2 Cleaning ............................................................................................................................ 31
7 Maintenance .............................................................................................. 33
7.1 Metrological check ............................................................................................................ 33
7.2 Adjusting the swivel-mounted tonometer holder with square mounting interface
(version a).......................................................................................................................... 34
7.3 Adjusting the swivel-mounted tonometer holder with round mounting interface (version
b) ....................................................................................................................................... 39
7.4 Checking the device........................................................................................................... 44
8 Troubleshooting......................................................................................... 47
9 Technical specifications.............................................................................. 51
9.1 Compliance........................................................................................................................ 51
9.1.1 Directives with which the device is compliant ................................................................................ 51
9.1.2 Classification of the device ............................................................................................................ 51
9.2 Device data........................................................................................................................ 51
9.3 Dimensions and weights.................................................................................................... 52
9.4 Ambient requirements....................................................................................................... 52
10 Optional accessories................................................................................... 53
11 Disposal of the device ................................................................................ 55
Glossary ..................................................................................................... 57
Index .......................................................................................................... 59

Instruction for use 1 Notes on the instructions for use
AT 030 1.1 Product name
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1 Notes on the instructions for use
1.1 Product name
AT 030 applanation tonometer is referred to as "device" in these
instructions for use.
1.2 Scope of application
The present instructions for use apply to AT 030 applanation
tonometer with the following labeling:
• Reference number: 319300-9120-000
1.3 Purpose and storage of the documentation
These instructions for use explain the safety features, functions and
performance parameters of the device. They contain instructions on
the safe use of the device and identify measures for its care and
maintenance.
Correct operation of the device is imperative for its safe and
successful functioning.
uRead these instructions for use before setting up and using the
device the first time.
uKeep the instructions for use accessible for all users at all times.
uPass the instructions for use to future owners of the device.
1.4 Questions and comments
uIf you have questions or comments concerning these instruc-
tions for use or the device itself, contact ZEISS Service.
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med
1.5 Conventions in this document
Certain types of information are specially marked in this document
for better recognition.
1.5.1 Conventions in all text areas
• This is a list.
– This is a second level list.
This is a cross-reference: Questions and comments [}5].
This is highlighted text.
This is software code or program text.

1 Notes on the instructions for use Instruction for use
AT 0301.6 Applicable documents
6 / 60 319300-9120-000-GA-GB-240320
Names of software dialogs, fields or menus, and software
messages are marked by quotation marks:
• "View" menu.
• "Do you want to save the settings?"
The steps in menu and file paths are separated by slashes:
• "File / Save as"
• "My documents / Documents"
Keys, buttons, knobs, levers and other operating controls are
marked by square brackets:
• [START] key
• [Next] button
1.5.2 Conventions in a course of action
WARNING! This is warning information about hazards that can cause
death or severe injuries if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
CAUTION! This is warning information about hazards that can cause
injuries if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
NOTE This is warning information about hazards that can cause
property damages if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
þThis is a requirement that must be met before the start of a
sequence of actions.
1. This is a command.
2. CAUTION!This is a warning message about hazards that
can occur during a single action. This is a command.
ðThis is the result of a sequence of actions.
1.6 Applicable documents
Please also refer to the instructions for use for additional compo-
nents and accessories to be used with this device.

Instruction for use 2 Safety notes
AT 030 2.1 Intended user profile
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2 Safety notes
2.1 Intended user profile
The device may only be installed, operated, used and maintained by
persons who have the necessary training, knowledge and
experience to do so. Please also adhere to the national qualification
guidelines applicable in your country.
Persons who operate the device must have knowledge of basic
ophthalmic examination and diagnosis methods as well as of
ophthalmic optics. This includes, among others, persons belonging
to the following occupational groups or their national equivalents:
• Ophthalmologist
• Optometrist
2.2 Area of use
2.2.1 Indication for use
The AT030 applanation tonometer is for measuring the intraocular
pressure of a seated patient.
2.3 Responsibilities and duties of the operator
Operating personnel
The device may only be operated by instructed and trained
personnel.
uEnsure that the operating personnel have been trained and
instructed.
uEnsure that the operating personnel have read and understood
the instructions for use.
uThe instructions for use should be readily accessible to the
operating personnel at all times.
uTo facilitate access for the entire operating personnel: If
necessary, request further copies of the instructions for use
from ZEISS.
uDefine the required skills for handling the device and provide
information on who is authorized for which activities.
uDefine rules for reporting errors and damage, and provide
information on these. Notification to manufacturers and
authorities [}8]
uRegularly check compliance with the national laws and regula-
tions concerning accident prevention and occupational health.

2 Safety notes Instruction for use
AT 0302.4 Measures and duties of the operator
8 / 60 319300-9120-000-GA-GB-240320
Maintenance and inspection
uTo ensure safe operation of the device and reach the expected
service life: Observe the maintenance and inspection intervals
that are specified in these instructions for use.
Modifications to the product
Modifications to the product or failure to follow the manufacturer’s
instructions may substantially reduce the expected service life and
significantly increase the risks associated with the use of this device
and are thus not permitted.
Accessories and additional equipment
uIf you want to connect accessories or additional equipment to
the device: Contact your ZEISS representative [}5].
2.3.1 Messages to manufacturer and authorities
If a serious incident occurs in connection with this medical device
affecting the operator or another person, the operator (or person
responsible) must report this serious incidence to the manufacturer
or seller of the medical product. In the European Union, the
operator must report this serious incident to the responsible
authorities in the applicable country.
2.4 Measures and duties of the operator
Ambient conditions
uMake sure that the installation conditions and the operation of
the device comply with the surgical requirements:
• Low vibration
• Clean environment
• Avoid extreme mechanical loads
uDo not store or use this device in damp areas. Do not expose
the device to water splashes, dripping water or sprayed water.
uEnsure that no liquids can enter the device.
Symbols and labels
uObserve the symbols and labels attached to the device.

Instruction for use 2 Safety notes
AT 030 2.5 Maintenance measures
319300-9120-000-GA-GB-240320 9 / 60
Transport
uWhen assembling or transporting the AT 030 applanation
tonometer, the measuring element must be set to 2.0 using the
rotary knob. Only in this way the measuring arm with the
measuring prism holder will be at a defined position.
uTransport the device over long distances (e.g. move, return for
repair, etc.) only in original packaging or special return
packaging.
uContact your dealer or ZEISS Service.
2.5 Maintenance measures
Maintenance procedures (maintenance and repairs) which are not
specified in these instructions for use may only be carried out by
persons authorized by Carl Zeiss Meditec and solely according to
the service instructions issued by Carl Zeiss Meditec. For planning
and implementing these maintenance and care procedures please
contact ZEISS Service or your local dealer.

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Instruction for use 3 Description of the device
AT 030 3.1 Package check list
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3 Description of the device
3.1 Package check list
The scope of delivery of the AT 030 applanation tonometer
includes the following components:
• AT 030 applanation tonometer
• Box with measuring prisms and test weights
• Documentation set
3.2 Device marking
Labels Explanation
AT 030 type label
Manufacturer
Date of manufacture
Disposal advice for EU
AT 030 identification label
REF Catalog/part number
SN Serial number
Label with manufacturing date
Sign with scale value

3 Description of the device Instruction for use
AT 0303.3 Structure of the device
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3.3 Structure of the device
1
2
3
4
5
5
6
7
8
10
9
Figure1: Control elements of the AT 030 applanation tonometer and the
swivel-mounted/fixed tonometer holder
1 AT 030 applanation
tonometer
2 Rotary knob of graduated
drum
3 Knurled screw 4 Base plate of fixed tonometer
holder
5 Alignment holes 6 Base plate of swivel-mounted
tonometer holder
7 Centering pin 8 Readout scale
9 Extensible measuring prism
holder
10 Measuring prism

Instruction for use 3 Description of the device
AT 030 3.4 Functional description
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3.4 Functional description
The AT 030 applanation tonometer may only be used according to
its indication for use if it is used in combination with a slit lamp. In
this combination, the slit lamp fulfills the following functions:
mechanical attachment of the tonometer, illumination and
magnified observation of the produced measuring pattern. During
operation, the ZEISS slit lamp does not have any impact on the
applanation tonometer, neither has the applanation tonometer any
impact on the functioning of the ZEISS slit lamp.
Following ZEISS slit lamps are compatible to AT 030: SL120,
SL130, SL220, SL800 and ZEISS VISULAS laser slit lamps.
The AT 030 applanation tonometer was designed for ZEISS slit
lamps according to the principle applied by Professor Goldmann.
The measuring device, containing a measuring prism with built-in
optical doubling system, is mounted on the slit lamp using a
dedicated tonometer holder and the applanation surface is
observed through the microscope of the slit lamp.
Further progress has been achieved by the use of a comparatively
small applanation surface requiring only small measuring forces, as
introduced by Professor Goldmann.
Professor Goldmann discovered that the counteracting forces of
corneal rigidity and capillary attraction of tear fluid neutralize each
other at an applanation surface of 3.06 mm diameter, so that the
applied force corresponds to the intraocular pressure.
The AT 030 works on the principle of force variation due to the
expansion of a spring. Therefore, it does not require any mainte-
nance or readjustment.
The measurement accuracy and repeatability of the AT 030
measuring results corresponds to the requirements of
ISO8612:2009.

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