Related Manuals for CSO Z800
Summary of Contents for CSO Z800
- Page 1 COSTRUZIONE STRUMENTI OFTALMICI APPLANATION TONOMETER INSTRUCTIONS FOR USE Z800 / F900 / A900 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it 1/174...
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Page 3: Table Of Contents
NVIRONMENTAL CONDITIONS ..............15 ISPOSAL AT THE END THE USEFUL LIFE DEVICE DESCRIPTION ................17 ..................17 ROVISION DESCRIPTION 3.1.1 Tonometer Z800 ....................20 3.1.2 Tonometer A900 ....................21 3.1.3 Tonometer F900 ....................22 ....................23 ECHNICAL DATA DEVICE USE ..................... 24 Z800 ........ - Page 4 Functioning check with measuring knob on 2............. 52 5.4.3 Functioning check with measuring knob on 6............. 54 ..............56 PARE PARTS AND ACCESSORIES LIST ..................58 ROUBLESHOOTING This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 2/60...
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Page 5: Introduction
Note. Useful information for the user General prohibition sign Manufacturer CE Marking (Directive 93/42/EEC) Identification number of the notified body (IMQ) This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 3/60... -
Page 6: Device Symbols
SLIT LAMP SL9800. THE DEVICES A900 AND F900 ARE ACCESSORIES COMPATIBLE WITH THE SLIT LAMP SL9900. Within the instructions for use, the devices are identified by Z800, F900 or A900. When not specified, the indications are applicable to all the devices. -
Page 7: Normative References
1.3.3 QUALITY MANAGEMENT SYSTEMS STANDARDS UNI CEI EN ISO 13845:2016 - Medical devices. Quality management systems - Requirements for regulatory purposes This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 5/60... -
Page 8: Warranty
Manufacturer damages caused by service lack or inefficiency, originating by causes or circumstances out of the Manufacturers control This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 6/60... -
Page 9: Manufacturer Identification
CSO S.r.l. Costruzione Strumenti Oftalmici Via degli Stagnacci, 12/E 50018 - Scandicci (FI) - ITALY phone: +39-055-722191 - fax +39-055-721557 cso@csoitalia.it www.csoitalia.it This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 7/60... -
Page 10: Safety
Before any measurement the contact surface of the measuring prism must be inspected for damages. If there is any anomaly, replace the prism. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 8/60... - Page 11 The measuring prism shall not be disinfected with other instruments or medical devices. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 9/60...
- Page 12 The device does not generate and does not receive any electromagnetic interference if it is placed near other electrical appliances. No preventive or corrective actions are required. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 10/60...
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Page 13: Device Identification
Salute website on this page: Ministero della Salute - Ricerca dispositivi 2.2.2 DEVICE DATA PLATE Fig 1 - Plate position tonometer Z800 Fig 2 - Plate position tonometer A900 Fig 3 - Plate position tonometer F900 Description Device data plate This document is the property of CSO Costruzione Strumenti Oftalmici srl. -
Page 14: Intended Use
INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 Fig 4 - Data plate for tonometer Z800 Fig 5 - Data plate for tonometer A900 Fig 6 - Data plate for tonometer F900 INTENDED USE The applanation tonometer is an accessory device for the slit lamps that enables to measure the intra-ocular eye pressure, for the diagnosis of some ophthalmological diseases. -
Page 15: Medical Devices Classification
The tonometers have to be installed on the slit lamp by means of their support accessory. The tonometers A900 and Z800 can be left on the slit lamp even when they are not in use, and if necessary, they can be placed in front of the microscope during the exam. -
Page 16: Medical Electrical Devices Classification
-10°C +60°C Atmospheric pressure 500 hPa 1060 hPa Relative humidity Temperature +15°C +30°C Atmospheric pressure 700 hPa 1060 hPa Relative humidity This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 14/60... -
Page 17: Disposal At The End The Useful Life
This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 15/60... - Page 18 Strict sanctions for transgressors are provided for by law. For specific information about the disposal in other countries than Italy, contact the local Dealer. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 16/60...
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Page 19: Device Description
PROVISION DESCRIPTION Device Z800 Fig 7 - Provision description Denomination Device Hex key Measuring prism Functioning check accessory Tonometer support (optional) This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 17/60... - Page 20 INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 Device A900 Fig 8 - Provision description Denomination Device Measuring prism Functioning check accessory Tonometer support (optional) This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 18/60...
- Page 21 Functioning check accessory Tonometer support guide For the list of accessories and available models contact the Manufacturer or the local Distributor. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 19/60...
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Page 22: Tonometer Z800
INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 3.1.1 TONOMETER Z800 Fig 10 - Tonometer Z800 Description Resting arm support Tonometer Z800 body Measuring scale knob Measuring prism support Functioning check accessory compartment This document is the property of CSO Costruzione Strumenti Oftalmici srl. -
Page 23: Tonometer A900
Description Fixing connection for tonometer A900 Connection support Functioning check accessory compartment Measuring scale knob Measuring prism support Tonometer A900 body This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 21/60... -
Page 24: Tonometer F900
TONOMETER F900 Fig 12 - Tonometer F900 Description Measuring prism support Functioning check accessory compartment Measuring scale knob Support Tonometer F900 body This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 22/60... -
Page 25: Technical Data
Between 0 and 80 mmHg (between 0 Measurement range and 10,64 kPa) Backlash width ≤ 0,49 mN Weight 0,48 kg (without accessories) This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 23/60... -
Page 26: Device Use
INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 DEVICE USE HOW TO INSTALL THE TONOMETER Z800 ON THE SLIT LAMP Install the tonometer support on top of the microscope, on its compartment. Block it with the screw on the device. Place the tonometer on the support pivot. -
Page 27: How To Install The Tonometer A900 On The Slit Lamp
Place the tonometer A900 connection support on the tonometer support. Fig 17 - How to place the tonometer support Fig 18 - How to place the tonometer A900 This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 25/60... - Page 28 The blocking position ensures the correct position of the tonometer during the measurement. Fig 19 - Blocking position measurement/rest This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 26/60...
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Page 29: How To Install The Tonometer F900 On The Slit Lamp
(operator's left or right eye). This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 27/60... -
Page 30: How To Prepare The Slit Lamp (Z800)
(operator's left eye) (operator's right eye) HOW TO PREPARE THE SLIT LAMP (Z800) The microscope has to be adjusted so that the measuring prism semicircles can be observed and clearly focused during the measurement. -
Page 31: How To Prepare The Slit Lamp (F900)
A wrong disinfection can cause cross-contamination between patients and operator and damages to the measuring prism. Detergent or disinfectant products residuals can cause eye irritations. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 29/60... - Page 32 During the measuring prism positioning use disposable gloves. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 30/60...
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Page 33: How To Place The Reusable Measuring Prism
Insert the measuring prism on the tonometer arm support. Place the measuring knob on position 1. Fig 24 - How to insert the measuring prism on the support This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 31/60... -
Page 34: How To Place The Disposable Measuring Prism
Place the measuring knob on position 1. Fig 25 - Disposable measuring prism Fig 26 - How to insert the measuring prism on the package support This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 32/60... -
Page 35: How To Prepare The Patient
Ask the patient to look towards the front and keep the eyes open during the exam. If necessary use the fixation target to help the patient to keep the eyes still. Fig 27 - Position of the tonometer Z800 Fig 28 - Position of the tonometer F900 (SL9800) -
Page 36: How To Measure The Intraocular Pressure
When the tonometer is in the right position, the two semicircles have the same dimension. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 34/60... -
Page 37: How To Measure The Intraocular Pressure In Astigmatic Patients
The problem can be overcome rotating the prism to 43°, on red sign positioned on the prism holder, in the respect of the flatter meridian. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 35/60... -
Page 38: Correcting The Wrong Acquisitions
If the two semicircles are in a wrong position, in what follows are described the possible causes and solutions to visualize the right position. Fig 32 - Right semicircles position This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 36/60... - Page 39 Repeat the measurement. unstable contact between measuring prism and eye. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 37/60...
- Page 40 The measurement might result Adjust the slit lamp height. way higher than the real one. Repeat the measurement. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 38/60...
- Page 41 Reduce the pressure by rotating centered but the sides are not the measurement knob until the correctly aligned two semicircles will be correctly aligned. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 39/60...
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Page 42: How To Read The Measuring Scale
Position on the measuring knob mmHg 9,81 1,33 19,62 2,66 29,43 39,9 39,24 53,2 49,05 66,5 58,86 79,8 68,67 93,1 78,48 10,64 This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 40/60... -
Page 43: How To Remove The Measuring Prism
Measuring prism cleaning at page 45 If you use a disposable measuring prism, dispose it immediately. Fig 33 - Measuring prism removal This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 41/60... -
Page 44: How To Remove The Tonometer Z800 From The Slit Lamp
INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 4.14 HOW TO REMOVE THE TONOMETER Z800 FROM THE SLIT LAMP Rotate the arm and place it on the protection bracket in resting position. Lift the tonometer too remove it from the support pivot. -
Page 45: Ordinary Maintenance
This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 43/60... -
Page 46: Device Cleaning
Clean the external parts of the device using a damp non-abrasive cloth to avoid damaging the material. CAUTION Danger of material damages. Do not use solvents or diluent to clean the device. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 44/60... -
Page 47: Measuring Prism Cleaning
Check the absence of dirt on the measuring prism integrity. Place the measuring prism in a clean and dry container. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 45/60... -
Page 48: Measuring Prism Disinfection
The measuring prisms shall be completely immersed in the disinfectant solution Let the disinfectant have its effect following the instructions of the disinfectant solution Producer. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 46/60... - Page 49 10 minutes, max 15 minutes. Remove the measuring prisms from the container. Fig 39 - Rinsing the measuring prism in the container This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 47/60...
- Page 50 Disinfection of Tonometers a Report by the American Academy of Ophthalmology 2017;124:1867-1875 a 2017 by the American Academy of Ophthalmology This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 48/60...
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Page 51: Tonometer Functioning Check
Fig 42 - How to place the functioning check Fig 43 - How to place the functioning check accessory on the tonometer Z800 accessory on the tonometer A900 and F900 This document is the property of CSO Costruzione Strumenti Oftalmici srl. -
Page 52: Functioning Check With Measuring Knob On 0
INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 Fig 44 - Marking on the functioning check Fig 45 - Marking on the functioning check accessory on the tonometer (Z800) accessory on the tonometer (A900 and F900) 5.4.1 FUNCTIONING CHECK WITH MEASURING KNOB ON 0 Position the functioning check accessory in position 0 (central) and the measuring knob on the corresponding value 0. - Page 53 INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 Fig 46 -Tonometer A900 measuring knob Fig 47 -Tonometer F900 measuring knob Fig 48 -Tonometer Z800 measuring knob This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited.
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Page 54: Functioning Check With Measuring Knob On 2
The arm should be displaced in stop position facing the patient. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 52/60... - Page 55 INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 Fig 51 -Tonometer A900 measuring knob Fig 52 -Tonometer F900 measuring knob Fig 53 -Tonometer Z800 measuring knob This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited.
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Page 56: Functioning Check With Measuring Knob On 6
The arm should be displaced in stop position facing the patient. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 54/60... - Page 57 INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 Fig 56 -Tonometer A900 measuring knob Fig 57 -Tonometer F900 measuring knob Fig 58 -Tonometer Z800 measuring knob This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited.
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Page 58: Spare Parts And Accessories List
Installation support for microscopes 2x - 5x galieian 100250303 and internal zoom new version 100212609 Installation support on zoom microscopes This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 56/60... - Page 59 INSTRUCTIONS FOR USE Z8A9F9 | IFU323EN00 Support for tonometer Z800 Code Description Installation support for microscopes 2x - 3x - 5x 100203101 galieian old version Installation support ( dominant left eye) for 100203102 microscopes 2x - 3x - 5x galieian old version...
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Page 60: Troubleshooting
Wrong horizontal and vertical Contact the alignment of the The arm is bent. Technical device in respect Assistance Center. to the microscope. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 58/60... - Page 61 Turn on use for the slit position or it is off. the light and adjust measurement. lamp. its intensity. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 59/60...
- Page 62 The applanation is not correctly Contact the The device might visualized during The arm is bent. Technical have been hit. Assistance Center. measurement. This document is the property of CSO Costruzione Strumenti Oftalmici srl. Any reproduction, even partial, it is prohibited. 60/60...
- Page 64 4/174 COSTRUZIONE STRUMENTI OFTALMICI phone: +39 055 722191 | fax: +39 055 721557 cso@csoitalia.it | www.csoitalia.it Z8A9F9 | IFU323EN00 - 09/2018...
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