OCULUS Corvis ST User manual

OCULUS Corvis®ST
INSTRUCTION MANUAL
Tonometer - Pachymeter

i / v Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
Noteson thisinstruction manual
Thank you for your purchase and the trust you have placed in this OCULUS product. The
Corvis® ST has been manufactured and tested according to strict quality criteria. You
have selected a modern and well-engineered product.
To ensure safe operation, it is essential that you use the device correctly. For this reason
you should familiarise yourself thoroughly with the contents of this instruction manual
before operating the device. In particular, pay attention to the safety instructions.
This instruction manual describes the measuring procedure of the Corvis® ST.
Due to ongoing development, the diagrams shown may depict minor changes to the
actual device delivered.
If you have any questions or wish to obtain further information on your device, please
contact us by phone, email or fax. Our service team is pleased to assist you.
OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 13485, setting high standards of quality
where development, manufacture, quality assurance and service regarding the entire
range of products are concerned.

Table of Contents
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) ii / v
Table of Contents
1 Scope of Delivery.........................................................................................................................1
2 Symbols .........................................................................................................................................2
3 Structure of the Documentation ............................................................................................3
4 Safety Instructions......................................................................................................................4
4.1 About this Manual .........................................................................................................4
4.1.1 Graphic symbols used..................................................................................4
4.2 Safety Instructions for Use..........................................................................................5
5 Indications for Use................................................................................................................... 11
6 Contraindications..................................................................................................................... 11
7 Warnings .................................................................................................................................... 11
8 Transport to Installation Location....................................................................................... 12
9 Device Description ................................................................................................................... 13
9.1 Overview of Device Components ............................................................................ 13
9.2 Mode of Operation of the Corvis® ST .................................................................... 15
10 Start-up ...................................................................................................................................... 17
10.1 Initial Start-up ............................................................................................................. 17
10.2 Set-up Jobs for Initial Start-Up .............................................................................. 17
10.3 Adjustments after an in-house transport............................................................. 18
10.3.1 Device set-up.............................................................................................. 18
10.3.2 Unlock transport safety device .............................................................. 18
10.4 Electrical Connection ................................................................................................. 19
10.5 Daily operation.............................................................................................................21
10.5.1 Switching on the Corvis® ST................................................................... 21
10.5.2 Setting the Safety Stop............................................................................ 21
10.5.3 Adjust the break......................................................................................... 21
10.5.4 Switching off the Corvis® ST.................................................................. 22
11 Preparing a measurement...................................................................................................... 23
11.1 Using the control unit................................................................................................ 23
11.2 Display with Touch Screen........................................................................................ 25
11.3 Start Patient Data Management............................................................................. 26
11.4 Importing patient data .............................................................................................. 27
11.4.1 Enter a new patient .................................................................................. 28
11.4.2 Select an existing patient ....................................................................... 29
12 Perform a Measurement ........................................................................................................ 31
12.1 Start the Corvis® ST Program at the Computer.................................................. 31
12.2 Adjusting the Corvis® ST ........................................................................................... 32
12.2.1 Rough Adjustment..................................................................................... 32
12.2.2 Fine Adjustment......................................................................................... 35
12.3 Triggering the measurement .................................................................................... 37

Table of Contents
iii / v Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
12.4 Perform a second measurement..............................................................................37
12.5 Saving data....................................................................................................................38
12.6 Complete measurement .............................................................................................39
12.7 Using Patient Data Management............................................................................40
12.7.1 Rename Patient Data ................................................................................40
12.7.2 Exporting Patient Data .............................................................................40
12.7.3 Data backup.................................................................................................41
12.7.4 Backup data.................................................................................................42
12.7.5 Reconstruct data........................................................................................42
12.7.6 Automatic backup......................................................................................43
13 Working with the Corvis® ST program ...............................................................................44
13.1 View patient and examination data (1).................................................................45
13.2 Working with the Menu Bar (7) ..............................................................................45
13.2.1 Menu item "Patient" .................................................................................45
13.2.2 Menu item "Examination" .......................................................................45
13.2.3 Menu item "Display" .................................................................................46
13.2.4 Menu item "Export“...................................................................................46
13.2.5 Menu item "Settings“ ...............................................................................46
13.3 Use video function (4) ................................................................................................46
13.4 View specific images of the cornea (4) .................................................................47
14 Perform a measurement with the Corvis® ST unit..........................................................48
14.1 Change Settings ...........................................................................................................48
14.2 Entering Patient Data .................................................................................................49
14.2.1 Entering new Patient ................................................................................50
14.2.2 Select an existing patient........................................................................51
14.3 Perform a Measurement ............................................................................................52
14.3.1 Selecting a Measurement Mode............................................................52
14.4 Complete measurement .............................................................................................52
14.5 Re-use examination data ..........................................................................................53
14.5.1 Delete a Patient or an Examination......................................................53
14.5.2 Re-using data with the USB flash drive (optional) ..........................53
15 Cleaning, Disinfection and Maintenance .........................................................................55
15.1 Cleaning..........................................................................................................................55
15.1.1 Clean the front panel................................................................................56
15.2 Disinfection....................................................................................................................58
15.3 Maintenance .................................................................................................................59
15.4 Attach paper to the chin rest...................................................................................59
15.5 Insert new printing paper roll ..................................................................................60
16 Dismantling, Transport and Storage....................................................................................62
16.1 Removal..........................................................................................................................62
16.2 Transport and Storage ................................................................................................63
16.3 Information on Transport and Storage..................................................................63
17 Disposal of Used Devices........................................................................................................64

Table of Contents
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) iv / v
18 Troubleshooting........................................................................................................................ 65
19 Terms of Warranty and Servicing........................................................................................ 66
19.1 Liability for proper function or damages.............................................................. 66
20 Technical Data .......................................................................................................................... 67
21 Appendix..................................................................................................................................... 69
21.1 Correction Calculation of the Tonometrically calculated IOP ........................ 69
21.2 Electromagnetic Compatibility................................................................................ 69
21.3 Guidance and Manufacturer’s Declaration -
Electromagnetic Emmisssions and Immunity for the Corvis® ST................... 71
21.4 Description of the Connection................................................................................. 75
21.5 Data sheet Power Supply Adapter (05150285) .................................................. 76

Table of Contents
v / v Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)

1 Scope of Delivery
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) 1 / 80
1 Scope of Delivery
We reserve the right to change the scope of delivery in line with ongoing
technical development.
When checking the delivery, if you discover transport damages,
immediately make your claim with the transport company.
Have the damage confirmed on the bill of lading, so that a proper
claim settlement is possible.
Keep the packing material.
Note
We reserve the right to change the scope of delivery in line with ongoing
technical development.
Component Order number
Corvis® ST
Corvis® ST package with laptop en
72100
72200
Dust protection cover 026010005001
Paper for chin rest 65313
Paper roll (3 rolls) 65311
USB cable 05200601
USB FS MED Isolator 015692000010
Power supply GSM90B15-P1M 05150285
Instruction Manual
User Guide
Software Installation
G/72100/XXXX/EN 1019 Rev01
BH/72100/EN...
SI/50000...en

2 Symbols
2 / 80 Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
2Symbols
Symbolson device Symbolspackaging
Manufacturer Protection class Keep dry
Conformité eu-
ropéenne
IP XX Type of protec-
tion
This way up
Follow instruction
for use
Article number Fragile
Disposal in house-
hold trash is prohib-
ited
Serial number Limit of temperature for
transport
Applied part Type B Caution Limit of temperature for
storage
US-Pat US patent
number
Limit of humidity
Example: UDI number, consisting UDI-
DI (Device-Identification)
UDI-PI (Product Identifier)
machine-readable matrix code
Limit of air pressure
Transport
Lagerung
Fig. 2-1: Type plate (example) Fig. 2-2: Type plate: measure head

3 Structure of the Documentation
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) 3 / 80
There are no temporarily fixed markings on the device.
3 Structure of the Documentation
A folder containing documentation is supplied with your Corvis® ST:
Instruction Manual: The design of the unit is described in detail in
this document. The instruction manual also gives you general infor-
mation about working with the Patient Data Management system
and all safety-related instructions for use of the Corvis® ST.
Attention
All safety-related instructions for use of the Corvis® ST are given in the
Instruction Manual for the unit. It is imperative that you read and under-
stand the whole Instruction Manual before you use the Corvis® ST.
User Guide: All features of the examination and analysis software
are described in the User Guide, along with detailed information
about the Patient Data Management system.
Software Installation: The introduction to the Software Installation
describes how to install the Corvis® ST software and the associated
drivers.
Symbolspower supply
Indoor use only Conform to US and
Canadian standards
Meets German
safety requirements
Notified body Nemkos symbol
Recycling Code Polarity of
DC connector

4 Safety Instructions
4 / 80 Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
4SafetyInstructions
4.1 About thisManual
Read the instruction manuals carefully.
Carefully store the instruction manuals near the device.
Observe the legal regulations with regard to accident prevention.
The instruction manuals describe the following versions:
control unit: from version 2.0.2007
measure head: from ersion 2.0.2013
The following software versions are used:
Corvis® ST program: from version 1.6r2015
Patient Data Management: from version 6.09
4.1.1 Graphic symbolsused
Warning
Identifies a potentially dangerous situation which may cause serious
bodily injuries.
Attention
Identifies a potentially dangerous situation which may cause minor injury
or damage to property.
Note
Instructions for use, and useful or important information.
☞
Identifies important information about the product or its operation,
which require special attention.

4 Safety Instructions
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) 5 / 80
4.2 Safety Instructionsfor Use
Attention
Personal or property damage due to false operation
Comply with the following safety instructions.
Personal or property damage due to unsafe equipment modifications
No modifications may be made to this device without the permission
of the manufacturer.
Information for the operators
Make sure that the Corvis® ST is used only by clinical persons or eye
spacialists
who can guarantee proper handling due to their knowledge,
training and practical experience.
who have been instructed by OCULUS staff or an authorized de-
aler before the initial operation.
Transport and Storage Instructions
Refer to the notes in sec. 16, page 62.
Information for set-up and connection
Do not use the Corvis® ST outdoors or in damp rooms, and do not
store the device there.
Keep the Corvis® ST away from water that may drip, splash or spray
on it, and make sure that no liquids can enter the Corvis® ST. Do not
place any containers holding liquids in the vicinity of the Corvis® ST.
Germany: Only operate the Corvis® ST in rooms used for medical
purposes if VDE 0107 installation procedures have been observed.
Do not operate the devices included in the delivery in areas where
explosions may occur, or in proximity to flammable anesthetics or
volatile substances such as alcohol, benzine or similar products.
Only use a power cord which meets the requirements of the
standards IEC 60227-1, Type H03VVH2-F, min. 0,75 m² and IEC
60320-1, Type C7.
Set up the Corvis® ST so that the power plug is easy to access. That
way, you can easily disconnect it from the power supply for any
repairs or maintenance work.

4 Safety Instructions
6 / 80 Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
Do not force any electrical connections. If you are unable to connect
a plug, check whether the plug fits the socket.
If you detect any damage to the connection, let our service personnel
repair the defect.
Establish an USB connection only with the OCULUS USB FS
MEDIsolator (Nr. 01 56920 00 010).
Note that an output voltage of maximum 5.5 V DC is supplied by a
device connected via USB.
Do not use the Corvis® ST with wireless technology, for example with
wireless USB.
Data responsibility: The device itself is not designed to connect with
the internet, but only with a PC. It does not require the internet to
function.
Do not connect with the internet while using the device. It is consid-
ered misuse.
If you elect to connect the PC to the internet for other purposes you
are responsible for ensuring data security.
Patient environment information
Patient environment is the area where patients can come into contact
with any part of a medical electrical equipment (ME equipment) or with
another person being in contact with the ME equipment.

4 Safety Instructions
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) 7 / 80
In the patient environment, use devices that conform to IEC 60601-1. If
a multiple power socket is to be used, or if a device is to be used that does
not meet the IEC 60601-1 standard, use an isolating transformer.
Information about the operation of an ME system
The Corvis® ST and a connected computer form a medical
electrical system (ME system) according to DIN EN 60601-1. If you
connect additional devices, such as, for example a printer, those devices
become part of the ME system.
Make sure that all devices of the ME system meet the requirements
of IEC 60601-1 or IEC 60950-1.
Note that an output voltage of maximum 5.5 V DC is supplied by a
device connected via USB.
Abb. 4-1: Patient environment

4 Safety Instructions
8 / 80 Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
Information about operation
Never put a damaged Corvis® ST into operation.
Only operate the Corvis® ST using original accessory parts supplied
by us, and only when the device is in technically correct working
order.
Before first use: Let OCULUS or an authorized dealer train you in the
operation of the Corvis® ST.
Only operate the device if you have understood the instruction
manuals.
Do not put the Corvis® ST, including the rechargeable battery or
cable, down onto devices that produce heat, heaters (e.g. radiators)
microwaves or similar.
Do not put any heavy objects onto the unit or the cables.
Information for Maintenance
Germany: The operating company must ensure that the device
undergoes technical measurement testing every 2 years according to
MPBtreibV, Appendix 2 Tonometer.
Only authorized persons are allowed to perform the software
updates.
To ensure that it functions correctly and safely we recommend the
following:
Have the Corvis® ST checked every two years by our service
department or an authorized dealer. If an error occurs which you are
unable to correct, label the Corvis® ST as "out of order" and contact
our service department or an authorized dealer.
Information for removal and disposal
When you disconnect electrical connections, pull on the respective
connectors, not the cord.
Dispose of the device according to legal regulations.
Instructions on Electrical Safety
Attention
Risk of personal injury or damage to property due to an incorrect level of
safety
Connecting the Corvis® ST with its non-medical electrical equipment (e.g.
data processing equipment) to a medical electrical system must not result
in a patient safety level below that prescribed by DIN EN ISO 60601-1. If
making this connection leads to the leakage current threshold being ex-
ceeded, protective measures including a circuit breaker must be in place.

4 Safety Instructions
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) 9 / 80
Ensure that connections with non-medical devices are made
correctly.
Only use the power adapter listed in the packing list.
Establish an USB connection only with the OCULUS USB FS
MEDIsolator (Nr. 01 56920 00 010).
Use only a computer that meets the specifications given in this
instruction manual, sec. 20, page 67.
Note that an output voltage of maximum 5.5 V DC is supplied by a
device connected via USB.
Attention
Use of a multiple socket extension cord
Risk of personal injury or material damage caused by unsafe multiple
socket extension cord
If you use a multiple socket extension cord to connect the
Corvis® ST to the power supply, you must heed the following information:
Use an extension cord that complies with the requirements of DIN
EN ISO 60601-1: 20005, section 16.
Do not place the multiple socket extension cord on the floor.
Do not use more than one multiple socket extension cord.
Plug only the Corvis® ST and the computer that is being used with
the unit (if applicable) into the multiple socket extension cord.
If you are using a multiple socket extension chord it has to be supplied
with a isolation transformer.
If you are using a new computer for the Corvis® ST, you must have the
electrical safety checked. Call OCULUS Service for this purpose.
Electromagnetic Compatibility (EMC) / Cables
Risk of personal injury or damage to property due to electromagnetic in-
terference
Portable and mobile RF communications equipment can affect medical
electrical equipment sec. 21, page 69.
Make sure that portable and mobile RF communications equipment
do not cause interference.
Recommendation: Maintain a minimum distance of 4 m. If the
distance is shorter, you must ensure that the Corvis® ST functions
correctly.

4 Safety Instructions
10 / 80 Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
Cybersecurity
☞
Precaution
Do not use the Corvis® ST with wireless technology, for example with
wireless USB
To ensure cyber security in order to the usage of the device, the following
security measures should be considered. Contact your computer
administrator:
Precautions for access control of the computer
Secure the computer with a password (for example at Windows start
up).
Choose a complex password: A good password should be at least
eight characters long and are not in the dictionary. In addition to
letters, it should also include numbers and special characters.
Do not choose a name or device name for a password (for example
“Corvis“).
Change the password regularly.
Do not note the password in an accessible location.
Use different passwords for different users.
Enable the screen saver and use the option for the necessity of re-
entering the password when exit the screen saver.
Choose an adequate time setting for starting the screen saver if
software session is inactive (e.g. 10 minutes). Adequate time setting
should consider duration of examination, number of patients, time
between examinations, use of other devices in the examination
room, several user, etc.
Lock the computer if you are leaving the workstation (shortcut:
‘windows logo key’ + ‘L’).
Precautions if the computer is connected to a LAN or internet network
Prefer wired connections of the computer to the network.
If you are using Wi-Fi connections nevertheless, please ensure the
usage of adequate security methods (for example WPA2/AES – Wi-
Fi Protected Access / Advanced Encryption Standard – with a strong
network key).
The usage of a firewall (software or hardware) is recommended.
Recommendation: Use anti-malware tools with up to date malware
definitions.
Note
Also observe the regulations, notes and recommendations of the
Bundesamt für Sicherheit in der Informationstechnik for the protection of
critical infrastructures.

5 Indicationsfor Use
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) 11 / 80
5Indicationsfor Use
The Corvis® ST is intended to measure intraocular pressure of the eye and
to photograph the eye and take Scheimpflug images of the anterior
segment of the eye to evaluate the thickness of the cornea.
The Corvis® ST is designed for hospitals and eye care professionals. The
device may only be used in environments that are intended for eye
examinations.
6 Contraindications
None known.
7 Warnings
The Corvis® ST is an automatic non-contact Tonometer with the
additional function of pachymetry which is a non-contact pachymeter.
The automatic non-contact tonometer function is the center of
application while the additional Pachymetry function give the examiner
first hints of any unusual values which were unknown before the
examination.
If some unusual corneal thickness values are present, further
examinations with devices like our Pentacam® might be necessary.
Furthermore if some unusual intraocular pressure values are preset,
further examinations with devices like the Goldman Tonometer might be
necessary.
Furthermore if some unusual intraocular pressure values are preset,
further examinations with devices like the Goldman Tonometer might be
necessary.

8 Transport to Installation Location
12 / 80 Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
8Transport to Installation Location
The transport and storage conditions see sec. 16, page 62.
Wait approx. 3-4 hours after transport before operating the Corvis®
ST. Extreme temperature changes from cold areas to warm rooms
can cause condensation on the optical components.
Note
Equipment damage due to incorrect transport and improper storage
Avoid shocks and vibration.
Avoid contamination, high temperatures and humidity.
Transport the Corvis® ST professionally.
Store the Corvis® ST according to the storage conditions.
Avoid placing near radiators and moisture.
Note
Keep the packing material. You can then ship or transport the unit
in the proper manner for any servicing or repairs that may arise. You
can thus avoid unnecessary damage and costs.

9 Device Description
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01) 13 / 80
9 Device Description
9.1 Overview of Device Components
Side - view
1 measure head 5 Joystick
2 Chin rest 6 Function keys
3 XY-base 7 Display
4 Control knob 8 Printout slot
Abb. 9-1: Corvis® ST: Side view
1
2
5
3
4
6
7
8

9 Device Description
14 / 80 Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
Front - view
1 Head rest 6 On/Off switch
2 Air nozzle / window of the slit lamp 7 Control LED
3 Lens protection glass 8 Mains connection
4 LED to illuminate the eye 9 USB port
5 Marking for the eye height 10 Safety stop
Abb. 9-2: Corvis® ST: Front view and connections
2
1
3
4
5
9
10
876