Instructions Manual
86 Pages
Preview
Page 1
Notes on this instruction 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.
i/v
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
Table of Contents
Table of Contents 1
Scope of Delivery...1
2
Symbols ...2
3
Structure of the Documentation ...3
4
Safety Instructions...4 4.1 4.2
About this Manual ...4 4.1.1 Graphic symbols used...4 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 9.2
Overview of Device Components ... 13 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 11.2 11.3 11.4
Using the control unit... 23 Display with Touch Screen... 25 Start Patient Data Management... 26 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
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
ii / v
Table of Contents
12.4 12.5 12.6 12.7
Perform a second measurement...37 Saving data...38 Complete measurement ...39 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
iii / v
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
Table of Contents
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
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
iv / v
Table of Contents
v/v
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
1 Scope of Delivery
1
Scope of Delivery
Component
Corvis® ST Corvis® ST package with laptop en
Order number
72100 72200
Dust protection cover
Paper for chin rest
65313
Paper roll (3 rolls)
65311
USB cable
USB FS MED Isolator
Power supply GSM90B15-P1M
Instruction Manual User Guide Software Installation
026010005001
05200601 015692000010
05150285 G/72100/XXXX/EN 1019 Rev01
BH/72100/EN... SI/50000...en
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.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
1 / 80
2 Symbols
2
Symbols
Symbols on device
Symbols packaging
Manufacturer
Protection class
Keep dry
Type of protection
This way up
Follow instruction for use
Article number
Fragile
Disposal in household trash is prohibited
Serial number
Transport
Limit of temperature for transport
Applied part Type B
Caution
Lagerung
Limit of temperature for storage
Conformité européenne
IP XX
US-Pat
US patent number
Limit of humidity
Example: UDI number, consisting UDIDI (Device-Identification)
Limit of air pressure
UDI-PI (Product Identifier) machine-readable matrix code
Fig. 2-1: Type plate (example)
2 / 80
Fig. 2-2: Type plate: measure head
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
3 Structure of the Documentation
Symbols power supply
Indoor use only
Conform to US and Canadian standards
Notified body
Nemkos symbol
Recycling Code
Polarity of DC connector
Meets German safety requirements
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 information 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 understand 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.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
3 / 80
4 Safety Instructions
4
Safety Instructions 4.1
About this Manual
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:
4.1.1
Corvis® ST program: from version 1.6r2015 Patient Data Management: from version 6.09
Graphic symbols used
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.
4 / 80
Identifies important information about the product or its operation, which require special attention.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
4 Safety Instructions
4.2
Safety Instructions for 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 dealer 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.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
5 / 80
4 Safety Instructions
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 considered 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.
6 / 80
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
4 Safety Instructions
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.
Abb. 4-1: Patient environment
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.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
7 / 80
4 Safety Instructions
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 exceeded, protective measures including a circuit breaker must be in place.
8 / 80
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
4 Safety Instructions
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 interference 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.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
9 / 80
4 Safety Instructions
☞
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 reentering 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 – WiFi 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.
10 / 80
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
5 Indications for Use
5
Indications for 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.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
11 / 80
8 Transport to Installation Location
8
Transport 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.
12 / 80
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
9 Device Description
9
Device Description
9.1
Overview of Device Components Side - view
1
2 8
7 6
5
3
4 1 measure head 2 Chin rest 3 XY-base 4 Control knob Abb. 9-1: Corvis® ST: Side view
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
5 6 7 8
Joystick Function keys Display Printout slot
13 / 80
9 Device Description
Front - view
1
5 2 4 3
8
7
6
9
10
1 Head rest 2 Air nozzle / window of the slit lamp 3 Lens protection glass 4 LED to illuminate the eye 5 Marking for the eye height Abb. 9-2: Corvis® ST: Front view and connections
14 / 80
6 7 8 9 10
On/Off switch Control LED Mains connection USB port Safety stop
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
9 Device Description
9.2
Mode of Operation of the Corvis® ST The Corvis® ST is a non-contact tonometer equipped with an optical Pachymetry function. The Corvis® ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. During the air puff the eye gets illuminated by a 9 mm slit through the apex and a built-in high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera uses a sequence of 140 Scheimpflug images of the cornea which are analyzed by a built-in computer. Intra ocular pressure is determined by the detection of the applanation moments of the cornea. Based on the Imbert-Fick principle the intraocular pressure is calculated by dividing the amount of air pressure into the area of applanated surface. The device increases the air pressure puffed onto the cornea in proportion to time. The shape of the cornea changes from the normal convex surface to a concave surface. This change is optically detected within 140 Scheimpflug images. The device calculates the time required to applanate (plane shape) the cornea with the air puff. The slit light illuminates a sectional plane from the front surface of the cornea to the back surface during the air puff. The transparent cells of the cornea scatter the slit light such that the sectional plane appears as if it were self-luminous. This is captured at an angle of 45° through the pupil by a camera, whereby the image plane of the camera is also tilted 45° to the optical axis of the camera lens, in order to sharply focus the light-scattering cornea plane onto the image plane of the camera (Scheimpflug image). Due to this arrangement, sharp sectional images of the cornea can be obtained. The pachymetry principle uses also the sectional images of the cornea. Corneal thickness and shape are obtained from images when the Cornea is not influenced by the air puff. Tonometry and Pachymetry are measured at the same measurement process.
Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)
15 / 80