Optos P200T E Series User manual

optos.com
USER GUIDE
Optos OCT Ophthalmoscope
P200TxE

G110230/1ENG
WARNING
Before using this system:
The system should be used by trained professionals. Before using the system, please
read the operating instructions and safety recommendations in this user guide.
Failure to follow the instructions for use and safety recommendations provided in this user
guide can cause injury to the patient, to the operator, or to other persons.
CAUTION
In the United States of America, Federal law restricts this device to sale by or on the order
of a physician.
Page 2 of 72 Part Number: G110230/1ENG
English Copyright 2019, Optos plc. All rights reserved.

Legal notice
Copyright 2019, Optos plc. All rights reserved.
Optos plc. products are protected by patents and patent applications listed at www.optos.com/patents.
The information contained within this document is subject to change without notice. The latest version of this
information can be found at optos.com.
This document should be used in conjunction with the assistance information supplied in each application.
Instructions and service information can be obtained by contacting Optos, see Contact us on page67.
Optos does not provide, and the optomap plus guidelines do not constitute advice on making reimbursement
claims. Diagnostic tests should be ordered by the treating physician and this physician is responsible for
appropriate usage, adequate documentation and proper coding. It is the responsibility of the physician to
comply with reimbursement regulations, and check with the local insurance carrier for reimbursement
information and instructions. Optos does not accept any liability for reimbursement claims made while using
this device.
Copyright
This document may only be used for your personal, non-commercial use. This document and all its contents
(including without limitation, all text, formats, graphics and logos) are the property of Optos plc and are
protected from unauthorized copying and dissemination by the Copyright, Designs and Patents Act 1988 (as
amended), by various intellectual property laws and by international conventions.
Trademarks
Optos, optomap, Daytona, Optos Daytona, California, Optos California, ResMax, 3D Wrap and are
registered trademarks. All rights reserved.
WINDOWS is a Trademark of Microsoft Corporation.
ADOBE and ACROBATREADER are Trademarks of Adobe Systems Incorporated.
All other trademarks are the property of their respective owners.
Part Number: G110230/1ENG
Release Date: August 2019
0197
Manufacturer
Optos plc
Queensferry House
Carnegie Campus
Enterprise Way
Dunfermline, Fife
KY11 8GR
UK
Part Number: G110230/1ENG Page 3 of 72
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Table of Contents
1 Warnings and cautions 11
1.1 General safety 11
1.2 Laser safety 13
1.3 Electrical safety 14
1.4 Environmental safety 14
1.5 EMC safety 15
1.6 Device failure 15
1.7 Cleaning guidelines 16
1.8 Maintaining information security 17
1.9 Data security 18
1.10 Software on Optos-supplied PCs 18
1.11 Symbol and label information 19
2 Introduction 21
2.1 Device description 21
2.2 Intended use 21
2.3 Intended users 21
2.4 Target environment 21
2.5 Contraindications 22
2.6 System configuration 22
2.6.1 System parts 22
2.6.2 Network specification and characteristics 23
2.6.3 Image modalities 24
2.6.3.1 SLO imaging modalities 24
2.6.3.2 OCT imaging modalities 25
2.6.3.3 Multi-mode workflow 26
2.6.4 System software 26
2.6.4.1 Understanding the review software 27
2.6.5 Accessories and detachable parts 27
3 How to... 29
3.1 Get started 29
3.1.1 Switch on each day 29
3.1.1.1 Switch on the image server 29
3.1.1.2 Switch on the scan head 29
3.1.1.3 Switch on browser-based review clients 30
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3.1.2 Use standby mode at the end of each day 30
3.1.2.1 Shut down the scan head 31
3.1.2.2 Log off the image server each day 31
3.1.2.3 Restart the image server each week 31
3.1.3 Use the system 32
3.1.3.1 Using the touch screen 32
3.1.3.2 Using the touch screen keyboard 32
3.1.3.3 Using the hand control 32
3.1.3.4 Using the chin rest and head rest 33
3.2 Capture images 34
3.2.1 Working with patient details 35
3.2.1.1 Working with Modality Work List (MWL) 36
3.2.1.1.1 How to search using MWL 36
3.2.2 How to prepare for image capture 36
3.2.3 How to align the patient 37
3.2.3.1 Patient coaching 37
3.2.3.2 Align the patient 37
3.2.4 How to capture SLO images 39
3.2.4.1 What to do after the image is captured 40
3.2.5 How to capture SLO eye steered images 40
3.2.6 How to capture SLO stereo images 41
3.2.7 How to capture SLO angiography images 42
3.2.7.1 Control contrast 42
3.2.8 How to capture OCT images 43
3.2.8.1 The patient's view of OCT alignment 44
3.2.8.2 How to optimize OCT scan quality 45
3.2.8.2.1 Capture scans quickly and recapture if necessary: 45
3.2.8.2.2 Using the auto-routines: 45
3.2.8.2.3 Live OCT positioning: 45
3.2.8.2.4 Minimizing eye dryness: 45
3.2.8.3 What to do after OCT image capture 46
3.2.8.4 SNR and OCT scan quality 46
3.2.9 Capture using Multi-mode 47
3.2.10 Manage the patient session 47
3.3 Review images 47
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3.3.1 Starting the review software 48
3.3.1.1 How to start the application 48
3.3.2 Reviewing patient images and scans 48
3.3.3 Exiting the review software 48
3.4 Manage the system 49
3.4.1 Managing user details 49
3.4.1.1 How to create user accounts for use on the scan head 49
3.4.1.2 How to create user accounts on the image server 49
3.4.1.3 How to change users 49
3.4.2 How to change the language on the scan head 49
3.4.3 How to change the language displayed in the review application 50
3.4.4 Storing and archiving images 50
3.4.5 Managing connections 50
3.4.6 Managing the Modality Work List 50
3.4.7 Quality checks 50
3.4.7.1 Self-tests 50
3.4.7.2 Status indicator 50
3.4.8 Maintenance 51
3.4.8.1 Servicing 51
3.4.8.2 Warranty 51
3.4.8.3 Cleaning 52
3.4.8.3.1 General cleaning 52
3.4.8.3.2 Cleaning before each patient 53
3.4.8.3.3 Cleaning the main mirror 53
3.4.8.3.4 Disinfection 54
3.4.8.4 Battery replacement 54
3.4.8.5 Cable management 55
3.4.9 Troubleshooting 55
3.4.9.1 Why can't Ilogin? 57
3.4.9.2 What information do I need when contacting Optos? 57
3.4.9.3 How do I image if the alignment system does not recognize the eye? 57
3.4.9.4 How do I restart the scan head? 57
3.4.9.5 How do I restart the image server? 58
3.4.9.6 What should I do if the PC drive on the image server is full? 58
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4 Technical Specification 59
4.1 Safety designation (IEC 60601-1) 59
4.1.1 Scan head 59
4.1.2 Connections 60
4.1.3 Scan head dimensions 60
4.1.4 Review client properties 61
4.1.5 Touch screen properties 61
4.1.6 Table requirements 62
4.1.7 Battery 62
4.1.8 Environmental considerations (ambient) 62
4.2 Laser safety designation (IEC 60825-1) 63
4.2.1 External Laser warning information 63
4.2.2 Internal Laser warning information 63
4.3 Electromagnetic compatibility (EMC) 63
4.3.1 Guidance and manufacturer declaration - electromagnetic emissions 64
4.3.2 Guidance and manufacturer declaration – electromagnetic immunity 64
4.3.3 Recommended separation distances 66
5 Contact us 67
5.1 Global Headquarters 67
5.2 Regional Offices 67
5.2.1 United States and Canada 67
5.2.2 Australia 68
5.2.3 Denmark 68
5.2.4 France 68
5.2.5 Germany and Austria 68
5.2.6 Norway 68
5.2.7 Spain 68
5.2.8 Sweden 69
5.2.9 Switzerland 69
5.2.10 United Kingdom and other European countries 69
Patient Alignment Guide 71
List of Tables
TABLE 1: Network specification 23
TABLE 2: List of parts 27
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TABLE 3: List of touch screen icons 32
TABLE 4: List of hand control buttons 33
TABLE 5: Examples of eye steering buttons 40
TABLE 6: Scan results 46
TABLE 7: List of status indicator lights 51
TABLE 8: List of problems and solutions 55
TABLE 9: Scan head safety designation details 59
TABLE 10: Scan head dimensions 61
TABLE 11: Review client properties 61
TABLE 12: Touch screen properties 61
TABLE 13: Table size requirements 62
TABLE 14: Environmental ranges 62
TABLE 15: List of electromagnetic emission compliance 64
TABLE 16: List of electromagnetic immunity compliance 64
TABLE 17: List of recommended separation distances 66
List of Figures
FIGURE 1: P200TxE device connected to network 22
FIGURE 2: Network data flow 24
FIGURE 3: Optos OCT line scan example position and scan pattern 25
FIGURE 4: Optos OCT raster scan example area, scan pattern and fixed center 25
FIGURE 5: Optos OCT retina scan example scan area and cross hairs 26
FIGURE 6: Optos OCT optic nerve head scan example target and scan lines 26
FIGURE 7: Hand control 33
FIGURE 8: Chin rest and head rest 34
FIGURE 9: Example capture and review workflow 35
FIGURE 10: Position of the canthus mark on the covers 37
FIGURE 11: Aligned patient 38
FIGURE 12: SLO capture workflow 39
FIGURE 13: OCT capture workflow 43
FIGURE 14: Indication of what the patient will see when being aligned for OCT imaging 44
FIGURE 15: Reviewing images workflow 48
FIGURE 16: Sample of the connection label 60
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Page 10 of 72 Part Number: G110230/1ENG
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Chapter 1 - Warnings and cautions
1 Warnings and cautions
Your system is a medical device and must be operated within the safety parameters and instructions defined
in this User Guide.
If the device appears faulty or has non-functioning components, please contact your Optos representative,
see Contact us on page67.
If you have any questions regarding the correct use of your device, please contact your Optos representative
before attempting to operate the device.
Read the warnings and cautions before using your device.
1.1 General safety
WARNING
Guidance for use on patients with Epilepsy
The device uses flashes of light. Some patients with epilepsy may be sensitive to flashes
of light. Caution should be exercised for patients who have a history of reaction to camera
flashes or strobe lighting.
Equipment modifications
No modification of this equipment is allowed.
Positioning scan head on table
The scan head should be positioned in the middle of the table width. The front of the scan
head should be inline with the front of the table to allow the patient to get into the correct
alignment position.
The chin rest should slightly overhang the edge of the table.
Suitability of images
The suitability of using an image or print for viewing is determined by the clinician.
Fluorescence Imaging
Optos does not offer any guidance or advice on the injection of imaging dyes. It is
recommended that only authorized and appropriately qualified physicians or MD's can use
angiography modalities that require medical interventions.
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Chapter 1 - Warnings and cautions
CAUTION
Day to day use - operators
The protection provided by the equipment may be impaired if the equipment is used in a
manner not specified by Optos.
The use of this device or any other device which uses light for ocular examination should
not be prolonged unnecessarily.
Do not place any optical elements, with the exception of the patient wearing contact
lenses, between the device and the patient’s eye.
Do not use lint cloths, tissues, or other materials that may create dust, on or near the scan
head. Always allow cleaned areas to air-dry.
The device requires low levels of room light to operate efficiently. Take care to avoid
accidents when working under low light conditions.
Do NOT touch the air vents.
Only use the fabric cover when the scan head is powered off or in standby mode. Remove
the fabric cover before operating the scan head.
OCT scans are described using external angles which can be converted to the nominal
'mm' using the scale factor derived from the wide-angle schematic eye model published
by Navarro et al 1. . The nominal scale factor is 3.47 degrees/mm for posterior region.
CAUTION
Day to day use - patients
Patients must not operate this device.
The patient should not touch the touch screen. The patient should only be in contact with
the forehead pad, chin pad and face pad.
When angiography images are being captured additional space will be required to allow
the injection of the dye and for other individuals involved in the procedure. These
individuals could include medical staff or patient helper.
Do not inject the patient until the appropriate point in the angiography procedure.
Do not capture images when the face pad is not in place.
Do not lean on the head rest, chin rest or table.
Ensure the head rest or chin rest do not restrict the patient’s access to the device.
The face pad may get warm during use.
The scan head will move when the alignment system is being centered. This will happen
automatically when the device is switched on and when the alignment system is re-
centered between patient sessions. You should ensure that there is space around the
scan head to allow free movement.
CAUTION
Signal to Noise Ratio
SNR2has a major impact on OCT image quality and therefore could determine the ability
to distinguish the retinal layers, see SNR and OCT scan quality on page46.
1. Isabel Escudero-Sanz and Rafael Navarro, "Off-axis aberrations of a wide-angle schematic eye model," J. Opt. Soc. Am. A 16, 1881-1891 (1999).
2. Signal to noise ratio
Page 12 of 72 Part Number: G110230/1ENG
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Chapter 1 - Warnings and cautions
CAUTION
Installation and maintenance
Your device will be installed by Optos trained personnel. Do not operate the device until
they have completed the installation and training.
Your Optos representative will configure the settings when the device is installed. These
settings should not be changed in the course of normal operation.
Please consult your Optos representative before changing the settings.
Do not remove the scan head covers. Only Optos trained technical personnel are
permitted to service the device.
The scan head weighs 45 kg (100 lbs) maximum. This requires two people to lift or carry
the unit.
You should be aware of your contractual obligations before disposing of any equipment.
Only Optos trained personnel are permitted to install and service the device.
Do not service the device when imaging a patient.
1.2 Laser safety
WARNING
Danger of laser injury
While no acute optical radiation hazards have been identified for direct or indirect
ophthalmoscopes, some patients may be less tolerant to an exposure of light. This may
be the case for infants, aphakic patients and persons with diseased eyes. Patients who
have had any exposure with the same device or with any other ophthalmic device using a
visible light source within the previous 24 hours may also be less tolerant to a further
exam using light.
CAUTION
The Laser Management System maintains a Class 1 accessible emission limit (AEL) at
the eye for normal operation and under foreseeable fault conditions.
While the scan head covers are fitted the risks are minimized. Images may only be
captured when the scanning system is within safe operating conditions. The following
items are monitored by the Laser Radiation Management System:
lInternal power monitoring prevents excess power at the eye.
lAn internal shutter and associated controls prevent early or prolonged laser
exposure.
Using the controls, adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
The P200TxE is a Class 1 laser device at the eye, and complies with IEC/EN 60825-
1:2014 and 21 CFR1040.10 and 1040.11 except for deviation pursuant to Laser Notice 50,
dated June 24, 2007.
Based on current scientific knowledge, a Class 1 laser device can be considered as safe
by engineering design, and safe under reasonably foreseeable conditions of operation.
The patient may experience some discomfort from exposure to light. It should be noted
that the benefits of an eye exam outweigh any discomfort.
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Chapter 1 - Warnings and cautions
1.3 Electrical safety
WARNING
Equipment classification
Electrical Shock Protection - Class 1 Equipment
Type B - relates to the allowable maximum leakage current which can flow from the
applied part. The limits for this are defined in IEC/EN 60601.
The applied parts are the forehead pad, chin pad and face pad.
Medical device. Continuous operation.
Do not open the scan head covers. There are no user serviceable or replaceable parts
inside.
Donot plug the scan head into a power block or powered table. The scan head must be
plugged directly into a wall socket.
Do not disconnect or connect the touch screen while the scan head is in use.
To prevent electric shock:
lOnly use cables supplied by Optos.
lCables should not be extended or altered.
lMains supply must be earthed.
lThe device may only be serviced by Optos trained personnel.
lCare must be taken never to touch exposed parts of the device while in physical
contact with a patient.
If the mains cable is damaged do not use the system and contact your Optos
representative, see Contact us on page67.
The image server, switch and any browser-based review clients or monitors must be
positioned outside the patient environment; more than 1.5 meters (5 ft) from the scan
head.
Do not connect any peripherals to the scan head. Only use peripherals supplied with the
device. Independently sourced peripherals may not be compatible. Contact your Optos
representative for more information on compatible peripherals, see Contact us on page67.
CAUTION
You must regularly inspect the equipment. If there is any damage please contact your
Optos representative, see Contact us on page67.
Ensure the mains socket is easily accessible.
1.4 Environmental safety
WARNING
Do not operate the device:
lIn the presence of explosive or flammable gases, flammable anaesthetic mixtures
or in oxygen rich environments.
lInside the influence of the magnetic field of a magnetic resonance imaging device.
lIn environments that block the scan head air intake vents.
lIn environments that exceed the environmental limits, see Environmental
considerations (ambient) on page62.
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Chapter 1 - Warnings and cautions
1.5 EMC safety
CAUTION
In order to provide reasonable interference protection against radio communication
services, this device has been tested and complies with 47 CFR Part 15, Sub Part B of
the FCC (U.S.A.) rules and IEC/EN 60601-1-2 standard requirements at the premises of a
typical user, and the CISPR11 standard emission limits (CISPR11 Group 1 Class B),
Guidance and manufacturer declaration - electromagnetic emissions on page64.
Although compliant with all applicable international EMC standards, the equipment
generates, uses and can radiate radio frequency energy. The equipment may cause radio
frequency interference to other medical and non-medical devices and radio
communications nearby.
There is no guarantee that interference will not occur in a particular installation.
If this device is found to cause interference (which may be determined by turning the
equipment on and off), the user or qualified service personnel should attempt to correct the
problem by one or more of the following measures:
lRelocate the affected device or devices
lIncrease the separation between the equipment and the affected device
lConsult the Optos service representative for further suggestions
CAUTION
Unauthorized changes or modifications will invalidate the warranty of this device.
The manufacturer is not responsible for any interference caused by using:
lInterconnect cables not supplied by Optos
lUnauthorized changes or modifications to this equipment
Do not use devices which intentionally transmit RF signals (cellular phones, transceivers
or radio controlled devices) in the vicinity of this equipment, as it may cause performance
outside the published specifications, see Recommended separation distances on
page66.
Adhering to the distance separation recommended will reduce the disturbances recorded
at the image level, but may not eliminate all disturbances, see Recommended separation
distances on page66. However, when installed and operated as specified herein the
system will maintain its essential performance by continuing to acquire, display and store
diagnostic quality images safely.
It is recommended that the image server is not used adjacent to or stacked with other
equipment.
The use of accessories and cables other than those specified may result in degraded
electromagnetic compatibility of the system.
1.6 Device failure
WARNING
In the unlikely event you hear a loud noise from the device, see smoke or smell burning,
stop imaging and isolate the device by unplugging.
If you suspect the device may be faulty see Troubleshooting on page55.
If the fault still persists, please contact your Optos representative, see Contact us on
page67.
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Chapter 1 - Warnings and cautions
CAUTION
Ensure the mains socket is easily accessible.
1.7 Cleaning guidelines
The device cleaning instructions are detailed in Cleaning on page52. Adhere to the following cautions while
cleaning the device.
CAUTION
Cleaning patient contact parts
In order to prevent any contamination always clean and disinfect parts of the equipment
which will be in contact with the patient, see Cleaning before each patient on page53.
Adequate cleaning and disinfection is necessary to prevent disease transmission.
Thoroughly clean and disinfect the equipment surfaces that contact the patient and all
equipment surfaces likely to become soiled during use.
Do not attempt to wash or immerse the patient contact parts (for example, forehead pad,
chin pad and face pad) in water or cleaning fluid.
CAUTION
Cleaning the main mirror
The mirror can be damaged during cleaning. Preventing mirror contamination reduces the
risk of damaging the mirror. It is not recommended to routinely clean the main mirror. Only
clean the mirror if dust particles, smudges or spots have accumulated on its surface.
When cleaning the main mirror, do not rub the spots too hard, as this may cause damage.
Do not touch the edges of the main mirror. The edges of the main mirror are sharp.
Only clean visible areas of the main mirror. Do not put your hand or any cleaning material
into parts of the device you cannot see.
Do not polish the mirror surfaces; clean only dust particles, smudges or spots.
Do not wear jewelry (for example rings, watches or bracelets) while cleaning the mirror
surface as this may damage the mirror.
Dispose of the dirty cloth after each wipe to avoid transferring the dust back on to the
mirror. You will have to use several wipes to clean the mirror.
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Chapter 1 - Warnings and cautions
CAUTION
Cleaning materials
Wear powder-free gloves at all times when cleaning the device including the scan head
and main mirror. If the gloves become contaminated they must be replaced immediately.
Do not use lint cloths, tissues, or other materials that may create dust, on or near the scan
head. Always allow cleaned areas to air-dry.
Improper cleaning methods or use of inappropriate cleaning and disinfecting agents can
result in the following:
lDamaged equipment
lPoor imaging performance
lIncreased risk of electric shock
Always follow the cleaning and disinfecting agents’ manufacturer’s instructions and
precautions; for storage, method of application, protective gloves, shelf life and disposal
to help assure effective and safe use of the product.
Be careful not to damage the scan head covers when cleaning.
Do not use harsh detergent, abrasive cleaners or solvents that are not recommended by
the manufacturer.
Do not expose equipment parts to steam or sterilizers as this will damage the device.
Do not allow liquids to get into the equipment.
If you believe cleaning sprays or liquids have got into the equipment, disconnect the
power supply and have the equipment checked by Optos qualified service personnel.
Do not let the cleaning wipes come into contact with the inside of the instrument.
Do not use the equipment until you have confirmed it is safe to use.
1.8 Maintaining information security
WARNING
Do not connect this equipment with any other equipment not provided in the accessory kit.
Do not use any cables, adapters, or products that are not provided or approved for the
device as this may result in non-compliance.
Part Number: G110230/1ENG Page 17 of 72
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Chapter 1 - Warnings and cautions
WARNING
IT networks used by medical devices
Connection of the P200TxE device to an IT network/data coupling that includes other
equipment could result in previously unidentified risks to patients, operators or third
parties.
The responsible organization should identify, analyze, evaluate and control these risks .
Subsequent changes to the IT network/data coupling could introduce new risks and
require additional analysis, and changes to the IT network/data coupling.
These include:
lchanges in the IT network/data coupling configuration
lconnection of additional items to the IT network/data coupling
ldisconnecting items from the IT network/data coupling
lupdate of equipment connected to the IT network/data coupling
lupgrade of equipment connected to the IT network/data coupling.
CAUTION
The scan head and image server should be kept in a secure location. You are responsible
for maintaining the security of information stored on the scan head and image server.
You are responsible for the security of user accounts and the maintenance of password
security.
1.9 Data security
CAUTION
Your System Administrator is responsible for backing up the image server. Backups must
be verified regularly to avoid patient data loss.
Only allow authorized personnel to access the data. Changes to data may lead to
incorrect diagnosis.
Implement measures to protect personal patient data from misuse.
If a critical error occurs during capture you should review the saved images and scans,
and recapture scans and images if necessary.
Exit OptosAdvance before turning off the image server.
You can install critical Windows Updates and antivirus signatures on the Image Server
PC and Viewing PCs by following the instructions displayed during the update.
1.10 Software on Optos-supplied PCs
CAUTION
Only install software when supplied and instructed by Optos.
Installing new software
Contact Optos Customer Support if you need to install other software, see Contact us on
page67.
Updating existing software
Your System Administrator should carry out software upgrades using the software and
instructions provided by Optos.
Do not accept software updates when you are about to image a patient.
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Chapter 1 - Warnings and cautions
1.11 Symbol and label information
Symbol and label information
Switch - off position.
Switch - on position.
Protective earth terminal.
Protective earth product is achieved via the mains input. Threaded studs are included on the
product as provision for mechanical fixing and an additional protective earth connection should
this be required.
Danger: high voltage warning.
WARNING
Warnings are directions which, if not followed, could cause:
lFatal or serious injury to a user, engineer, patient or any other person.
lDamage to the equipment described in this manual and/or other equipment or goods.
lEnvironmental pollution.
CAUTION
Cautions are directions which, if not followed, could cause:
lA hazardous situation for a user, engineer, patient or any other person.
lDamage to the equipment or loss of data.
Interference may occur in the vicinity of equipment marked with this symbol.
Laser device present. This symbol is used internally. Only Optos trained personnel are
permitted to service the device. Under normal use, operators should never see this symbol.
Date of manufacture.
Manufacturer.
Type B - relates to the allowable maximum current leakage which can flow from the applied
part. The limits for this are defined in IEC 60601.
SN
Serial Number.
0197
In accordance with Directive 93/42/EEC.
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Chapter 1 - Warnings and cautions
Symbol and label information
Consult accompanying documents.
Disposal in compliance with WEEE Directive.
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