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1 5.4.3 Consult instructions for use Indicates the need for the user to consult the instructions for use electronic Table D.1 11 IEC electronic equipment Part 2-18: Particular the performance of endoscopic 101 Endoscope Endoscope 5335 Type CF applied part To identify a type CF applied part complying with. electronic Table D.1 21 Symbols Glossary Rev. 1 1 / 16

2 5333 Type BF applied part To identify a type BF applied part complying with. electronic Table D Type B applied part To identify a type B applied part complying with. electronic Table D.1 19 electronic 5336 Defibrillation-p roof type CF applied part Table D.1 27 To identify a defibrillation-proof type CF applied part complying with IEC Caution, hot surface To indicate that the marked item can be hot and should not be touched without taking care. Symbols Glossary Rev. 1 2 / 16

3 Reference Symbol Title Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented 0434A on the itself. electronic Table D Batch code Indicates the manufacturer s batch code so that the batch or lot can be identified Serial number Indicates the manufacturer s serial number so that a specific can be identified Symbols Glossary Rev. 1 3 / 16

4 5.1.6 Catalogue number Indicates the manufacture s catalogue number so that the can be identified electronic Do not re-use Indicates a medical device that is intended for one use, or a single patient during a single procedure Table D Use-by date Indicates the date after which the medical device is not to be used Symbols Glossary Rev. 1 4 / 16

5 5.2.4 Sterilized using irradiation Sterilized using ethylene oxide Sterilized using steam or dry heat Indicates a medical device that has been sterilized using irradiation. Indicates a medical device that has been sterilized using ethylene oxide. Indicates a medical device that has been sterilized using steam or dry heat Keep away from sunlight Indicates a medical device that needs protection from light sources Symbols Glossary Rev. 1 5 / 16

6 Reference Symbol Title Keep dry Indicates a medical device that needs to be protected from moisture Do not resterilize 2608 Indicates a medical device that is not to be resterilized Non-sterile Indicates a medical device that has not been subjected to a sterilization process Contains or presence of natural rubber latex 5.4.5* Not Made with Natural Rubber Latex Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the or the packaging of a medical device. Indicates a medical device that does not contain natural rubber latex. *Annex B B.2 is applied to the reference number of symbol: Symbols Glossary Rev. 1 6 / 16

7 5.2.8 Do not use if package is damaged Upper limit of temperature Lower limit of temperature Temperature Limit Indicates a medical device that should not be used if the package has been damaged or opened. Indicates the upper limit of temperature to which the medical device can be safely exposed. Indicates the lower limit of temperature to which the medical device can be safely exposed. Indicates the temperature limits to which the medical device can be safely exposed Manufacturer Indicates the medical device manufacturer Authorized representative in the European Community Indicates the Authorized representative in the European Community. Symbols Glossary Rev. 1 7 / 16

8 BS EN 15986:2011 Symbol for use in the labelling of s Requirements for labelling of medical devices containing phthalates electronic electronic electronic Date of manufacture 2497 Figure A.1 Table D.2 10 Table D.2 2 Table D.2 9 Contains or presence of phthalate (DEHP) Follow instructions for use warning sign mandatory action sign 5032 Alternating current Indicates the date when the was manufactured. Contains or presence of phthalate: bis(2-ethylhexyl)phthal ate (DEHP) Follow instructions for use warning sign mandatory action sign To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. Symbols Glossary Rev. 1 8 / 16

9 electronic electronic 5021 Equipotentiality Table D Non-ionizing electromagnetic radiation Table D.3 2 Ingress protection rating is Electrostatic sensitive devices 5010 ON / OFF (push-push) To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding. To indicate generally elevated, potentially hazardous, levels of non-ionizing radiation, or to indicate equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment. Protected against the effects of temporary immersion in water. To indicate packages containing electrostatic sensitive devices, or to identify a device or a connector that has not been tested for immunity to electrostatic discharge. To indicate connection to or disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved. Symbols Glossary Rev. 1 9 / 16

10 Reference Symbol Title 5007 On (power) To indicate connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved Off (power) To indicate disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved Start; start of To identify the start action button White balance To identify the controls that adjust the white balance Brightness; brilliance To identify the brightness control Fuse To identify fuse boxes or their location Menu To identify the control by which the menu (availability of options) can be displayed. 5525A Video input To identify video equipment input controls and connecting terminals. 5529A Video output To identify video equipment output controls and connecting terminals. Symbols Glossary Rev / 16

11 0018 Lock; tighten Lock or tighten Unlock; unclamp Unlock or unclamp Foot switch To identify a foot switch or the connection for a foot switch Earth; ground To identify an earth (ground) terminal ON for a part of equipment To indicate the ON condition for a part of equipment OFF for a part of equipment To indicate the OFF condition for a part of equipment Input To indicate an input terminal Output To indicate an output terminal Short-circuitproof transformer To identify a transformer which can withstand a short-circuit, inherently or non-inherently. Symbols Glossary Rev / 16

12 Reference Symbol Title 5002 Position of cell On and in battery holders. EN Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC (WEEE) NA Crossed-out wheeled bin To indicate that the product shall be separated when disposal. BS EN ISO 780: 2015 Packaging. Distribution packaging. Graphical symbols for handling and storage of packages 3 Fragile, handle with care Contents of the distribution packages are fragile therefore it shall be handled with care BS EN ISO 780: 2015 Packaging. Distribution packaging. Graphical symbols for handling and storage of packages 13 This way up This is the correct upright position of the distribution packages for transport and/or storage Symbols Glossary Rev / 16

13 BS EN ISO 780: 2015 Packaging. Distribution packaging. Graphical symbols for handling and storage of packages 16 Stacking limit by number Maximum number of identical transport packages/items which may be stacked on the bottom package, where n is the limiting number BS EN ISO 780: 2015 Packaging. Distribution packaging. Graphical symbols for handling and storage of packages 17 Do not stack Stacking of the distribution packages is not allowed and no load shall be placed on the distribution packages ISO : One-way valve Indicates a medical device with a valve that allows flow in only one direction Symbols Glossary Rev / 16

14 ISO : Humidity limitation Indicates the range of humidity to which the can be safely exposed ISO : Atmospheric pressure limitation Indicates the range of atmospheric pressure to which the medical device can be safely exposed ISO 7010 Safety colours and safety signs Registered safety signs ISO 7010-P00 1 prohibition sign To signify a prohibited action Stand-by To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition Lamp; lighting; illumination To identify switches which control light sources. Symbols Glossary Rev / 16

15 Reference Symbol Title 5110B Stop To identify the control or the indicator to stop the active function Adjustment to a maximum 5181 Variability in steps 5184 Clock; time switch; timer To identify the control by means of which a quantity is adjusted to its maximum value. To identify the device by which a quantity is controlled. To identify terminals and controls related to clocks, time switches and timers Iris diaphragm, open To identify the control for opening the iris diaphragm or to indicate the open state Air impeller, feeding 0017 Automatic control (closed loop) To identify the switch or control which operates the air impeller for air feeding. To indicate any automatic closed loop function Suction To indicate the generation of an air current by the use of suction (for example, for the removal of dust or particulate matter, or lifting of light material (such as paper) by suction). Symbols Glossary Rev / 16

16 ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment Reference Symbol Title 0096 Manual control To identify a manually operated control. To identify the switch position that places the equipment under manual (as opposed to automatic) control. To identify the control that activates manual control. To indicate that the equipment is in manual control mode. FIG. 6 MR Conditional To identify an item with demonstrated safety in the MR environment within defined conditions. Symbols Glossary Rev / 16