Optos P200TxE User manual

User Guide
Optos OCT Ophthalmoscope
P200TxE
G110230-003-ENG

G110230-003-ENG
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.
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Legal notice
Copyright 2019-2021, 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79).
Optos does NOT provide guidelines on making reimbursement claims. Diagnostic tests should be ordered
by the consulting physician and this physician is responsible for appropriate usage, adequate
documentation and accurate 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, RESMAX, DAYTONA, CALIFORNIA, SILVERSTONE, OPTOS CALIFORNIA,
OPTOS MONACO, OPTOS SILVERSTONE, 3D WRAP, , and optomap 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: G110230-003-ENG
Release Date: 16Sep2021
0197
Manufacturer
Optos plc
Queensferry House
Carnegie Campus
Enterprise Way
Dunfermline, Fife
KY11 8GR
UK
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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 15
1.5 EMC safety 15
1.6 Device failure 16
1.7 Cleaning guidelines 16
1.8 Maintaining information security 18
1.9 Data security 18
1.10 Software on Optos-supplied PCs 19
1.11 Symbol and label information 19
2 Introduction 21
2.1 Device description 21
2.2 Clinical benefits statement 21
2.3 Intended use 21
2.4 Intended users 22
2.5 Target environment 22
2.6 Contraindications 22
2.7 System configuration 22
2.7.1 System parts 23
2.7.2 Network specification and characteristics 24
2.7.3 Image modalities 24
2.7.3.1 SLO imaging modalities 25
2.7.3.2 OCT imaging modalities 25
2.7.3.3 Multi-mode workflow 27
2.7.4 System software 27
2.7.4.1 Understanding the review software 27
2.7.5 Accessories and detachable parts 28
3 Get started 29
3.1 Switch on each day 29
3.1.1 Switch on the image server 29
3.1.2 Switch on the scan head 29
3.1.3 Switch on browser-based review clients 30
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3.2 Use standby mode at the end of each day 30
3.2.1 How to shut down the scan head 31
3.2.2 Install software updates 31
3.2.3 Log off the image server each day 31
3.2.4 Restart the image server each week 32
3.3 Use the system 32
3.3.1 Using the touch screen 32
3.3.2 Using the touch screen keyboard 33
3.3.3 Using the hand control 33
3.3.4 Using the chin rest and head rest 34
4 Capture images 35
4.1 Selecting and managing patient details 35
4.1.1 Adding a new patient 36
4.1.2 Selecting and editing existing patient 36
4.1.3 Selecting a Patient Order from MWL 36
4.1.4 Working with Modality Work List (MWL) 36
4.1.5 How to search using MWL 36
4.2 How to prepare for image capture 36
4.3 How to align the patient 37
4.3.1 Patient coaching 37
4.3.2 Align the patient 37
4.4 How to capture SLO images 39
4.4.1 What to do after the image is captured 40
4.5 How to capture SLO eye steered images 40
4.6 How to capture SLO stereo images 41
4.7 How to capture SLO angiography images 42
4.7.1 Control contrast 42
4.8 How to capture OCT images 43
4.8.1 The patient's view of OCT alignment 44
4.8.2 How to optimize OCT scan quality 44
4.8.2.1 Capture scans quickly and recapture if necessary 45
4.8.2.2 Using the auto-routines 45
4.8.2.3 Live OCT positioning 45
4.8.2.4 Minimizing eye dryness 45
4.8.3 How to capture an OCT follow-up scan 45
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4.9 How to check OCT scans 46
4.9.1 Artifacts - Low signal strength 47
4.9.2 Artifacts - Eye movements 49
4.9.3 Artifacts - Blinks 49
4.9.4 Artifacts - Clipping 50
4.9.5 Artifacts - Alignment of essential structures 50
4.10 How to capture using Multi-mode 50
4.11 How to manage the patient session 51
5 Review images 53
5.1 Starting the review software 53
5.1.1 How to start the application 53
5.2 Reviewing patient images and scans 53
5.3 Exiting the review software 54
6 Manage the system 55
6.1 Managing user details 55
6.1.1 How to create user accounts for use on the scan head 55
6.1.2 How to create user accounts on the image server 55
6.1.3 How to change users 56
6.2 How to change the language on the scan head 56
6.3 How to change the language displayed in the review application 56
6.4 Storing and archiving images 56
6.5 Managing connections 56
6.6 Managing the Modality Work List 56
6.7 Quality checks 57
6.7.1 Self-tests 57
6.7.2 Status indicator 57
6.7.3 Software update 57
7 Maintenance and cleaning 59
7.1 Servicing 59
7.2 Warranty 59
7.3 Cleaning 60
7.3.1 General cleaning 60
7.3.2 Cleaning before each patient 61
7.3.2.1 How to remove the head and chin rests 61
7.3.3 Cleaning the main mirror 61
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7.3.4 Disinfection 62
7.4 Battery replacement 63
7.5 Cable management 63
8 Troubleshooting 65
8.1 Why can't Ilogin? 66
8.2 What information do I need when contacting Optos? 67
8.3 How do I image if the alignment system does not recognize the eye? 67
8.4 How do I restart the scan head? 67
8.5 How do I restart the image server? 67
8.6 What should I do if the PC drive on the image server is full? 68
9 Technical Specification 69
9.1 Safety designation (IEC 60601-1) 69
9.1.1 Scan head 69
9.1.2 Connections 70
9.1.3 Scan head dimensions 71
9.1.4 Review client properties 71
9.1.5 Touch screen properties 71
9.1.6 Table requirements 72
9.1.7 Battery 72
9.1.8 Environmental considerations (ambient) 72
9.2 Laser safety designation (IEC 60825-1) 73
9.2.1 External Laser warning information 73
9.2.2 Internal Laser warning information 74
9.3 Electromagnetic compatibility (EMC) 74
9.3.1 Guidance and manufacturer declaration – electromagnetic emissions 74
9.3.2 Guidance and manufacturer declaration – electromagnetic immunity 74
9.3.3 Recommended separation distances 76
10 Contact us 79
10.1 Global Headquarters 79
10.2 Regional Offices 79
10.2.1 United States and Canada 79
10.2.2 Australia 80
10.2.3 Denmark 80
10.2.4 France 80
10.2.5 Germany and Austria 80
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10.2.6 Norway 80
10.2.7 Spain 81
10.2.8 Sweden 81
10.2.9 Switzerland 81
10.2.10 United Kingdom and other European countries 81
10.3 European Authorized Representative 82
Patient Alignment Guide 83
List of Tables
TABLE 1: Network specification 24
TABLE 2: List of parts 28
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: Examples of stereo buttons 41
TABLE 7: Scan results 46
TABLE 8: List of status indicator lights 57
TABLE 9: List of problems and solutions 65
TABLE 10: Scan head safety designation details 69
TABLE 11: Scan head dimensions 71
TABLE 12: Review client properties 71
TABLE 13: Touch screen properties 72
TABLE 14: Table size requirements 72
TABLE 15: Environmental ranges 73
TABLE 16: List of electromagnetic emission compliance 74
TABLE 17: List of electromagnetic immunity compliance 74
TABLE 18: List of recommended separation distances 76
List of Figures
FIGURE 1: P200TxE device connected to network 23
FIGURE 2: Network data flow 24
FIGURE 3: Optos OCT line scan example position and scan pattern 26
FIGURE 4: Optos OCT raster scan example area, scan pattern and fixed center 26
FIGURE 5: Optos OCT retina scan example scan area and cross hairs 26
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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 38
FIGURE 11: Aligned patient 38
FIGURE 12: OCT capture workflow 43
FIGURE 13: Indication of what the patient will see when being aligned for OCT imaging 44
FIGURE 14: Examples of local weak signal strength. 48
FIGURE 15: Example of local weak signal near the fovea. 48
FIGURE 16: Example of local weak signal with acceptable global SNR. 48
FIGURE 17: Possible movement detected. 49
FIGURE 18: Possible blink detected. 49
FIGURE 19: Example of clipped B-Scan. 50
FIGURE 20: Example of clipping near the fovea. 50
FIGURE 21: Example of clipping near the optic disc. 50
FIGURE 22: Reviewing images workflow 53
FIGURE 23: Sample of the connection label 70
Page 10 of 84 Part Number: G110230-003-ENG
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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 you identify a serious issue related to the safety and performance of your device or a public health risk
you should forward the details to the relative authority and your Optos representative (see Contact us on
page79).
If the device appears faulty or has non-functioning components, please contact your Optos representative.
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.
Measurements on Optos UWF optomap and OCT images are based on scale factors
derived from the wide-angle schematic eye model published by Navarro et al1. . This
model describes a spherical 24mm representation and is embodied into the DICOM
encoding Supplement 173: Wide Field Ophthalmic Photography Image Storage SOP
Classes.
Measurements in third party viewers may not be accurate.
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.
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).
Page 12 of 84 Part Number: G110230-003-ENG
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Chapter 1 - Warnings and cautions
CAUTION
Signal to Noise Ratio
SNR has a major impact on OCT image quality and therefore could determine the ability
to distinguish the retinal layers (see How to optimize OCT scan quality on page44).
Images with SNR below 6 should be re-taken if possible or interpreted with caution.
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.
Please consult your Optos representative before moving the device.
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
In accordance with IEC 60825-1 Ed. 3, the Laser Management System maintains a
Class 1 accessible emission limit (AEL) at the eye for normal operation and under
foreseeable fault conditions. Based on current scientific knowledge, a Class 1 laser
device can be considered as safe by engineering design.
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 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79).
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79).
CAUTION
Ordinary equipment without protection against ingress of water.
You must regularly inspect the equipment. If there is any damage please contact your
Optos representative (see Contact us on page79).
The device is isolated from the mains by the main power cable and IEC connector. In an
emergency, the device should be isolated by unplugging from the mains power supply.
Ensure the mains socket is easily accessible.
Page 14 of 84 Part Number: G110230-003-ENG
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Chapter 1 - Warnings and cautions
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72).
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)
(see Guidance and manufacturer declaration – electromagnetic emissions on page74).
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
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Chapter 1 - Warnings and cautions
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76).
Adhering to the distance separation recommended will reduce the disturbances
recorded at the image level, but may NOT eliminate all disturbances (see List of
recommended separation distances on page76). 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 parts 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 from the mains power supply.
If you suspect the device may be faulty (see Troubleshooting on page65).
If the fault still persists, please contact your Optos representative (see Contact us on
page79).
CAUTION
The device is isolated from the mains by the main power cable and IEC connector. In an
emergency, the device should be isolated by unplugging from the mains power supply.
Ensure the mains socket is easily accessible.
1.7 Cleaning guidelines
The device cleaning instructions are detailed in this User Guide (see Cleaning on page60). 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61).
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.
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Chapter 1 - Warnings and cautions
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.
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.
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Chapter 1 - Warnings and cautions
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.
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 anti-virus signatures on the Image Server
PC and Viewing PCs by following the instructions displayed during the update.
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Chapter 1 - Warnings and cautions
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79).
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.
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.
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Chapter 1 - Warnings and cautions
Symbol and label information
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.
Serial Number.
Indicates the item is a medical device.
Authorized representative in the European Community.
0197
In accordance with Directive 93/42/EEC.
Consult accompanying documents.
Disposal in compliance with WEEE Directive.
Page 20 of 84 Part Number: G110230-003-ENG
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