omron healthcare, inc. symbols glossary glossary symbol standard no./standard title standard...

OMRON Healthcare, Inc.Symbols Glossary

Symbol Standard No./Standard Title Standard Reference No. / Symbol Title Symbol Meaning

ISO 15223-1 / Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied

5.1.1 / Manufacturer Indicates the medical device manufacturer


5.1.2 / Authorized representative in the European Community

Indicates the authorized representative in the European union. Symbol is accompanied by the name and address of the authorized representative adjacent to the symbol


5.1.3 / Date of Manufacture

Indicates the date when the medical device was manufactured


5.1.4 / Use-by-date Indicates the date after which the medical device is not to be used


5.1.5 / Batch code Indicates the manufacturer’s batch code or lot can be identified


5.1.6 / Catalogue numberIndicates the manufacturer’s catalogue number so the medical device can be identified


5.1.7 / Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified


5.2.8 / Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damaged or opened


5.3.1 / Fragile, handle with care

Indicates a medical device that can be broken or damaged if not handled carefully


5.3.4 / Keep dry Indicates a medical device that needs to be protected from moisture

Symbol Standard No./Standard Title Standard Reference No. /Symbol Title Symbol Meaning


5.3.5 / Lower limit of temperature

Indicates the lower limit of temperature to which the medical device can be safely exposed


5.3.6 / Upper limit of temperature

Indicates the upper limit of temperature to which the medical device can be safely exposed


5.3.7 / Temperature limit Indicates the temperature limits to which the medial device can be safely exposed


5.3.8 / Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed


5.3.9 / Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed


5.4.3 / Consult instructions for use

Indicates the need for the user to consult the instructions for use


5.4.4 / CautionIndicates the need for the user to consult the instructions for use for important information such as warnings and cautions

IEC 60417 / Graphical symbols for use on equipment

5333 / Type BF applied part

Identifies a type BF applied part complying with IEC 60601-1


5840 / Type B applied part

Identifies a type B applied part complying with IEC 60601-1

IEC 60417 / Graphicalsymbols for use on equipment 5172 / Class II equipment

Identifies equipment meeting the safety requirements specified for Class II equipment according to IEC 61140


5926 / Polarity of d. c. power connector

Identifies the positive and negative connections of a d. c. power supply


5957 / For indoor use only

Identifies electrical equipment designed for indoor use


IEC 60417 / Graphical symbols for use on equipment 5032 / Alternating Current

Indicates that the equipment is suitable for alternating current only; to identify relevant terminals

IEC 60417 / Graphical symbols for use on equipment 5031 / Direct current

Indicates that the equipment is suitable for direct current only; to identify relevant terminals

IEC 60417 — Graphical Symbols for Use on Equipment

5140 / Non-ionizing electromagnetic radiation

Indicates generally elevated, potentially hazardous, levels of non-ionizing radiation, or to indicate equipment or systems e.g. that intentionally apply RF electromagnetic for diagnosis or treatment

IEC 60417 / Graphical symbols for use on equipment 5009 / Stand-by

Identifies 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

IEC 60417 / Graphical symbols for Use on Equipment

5016 / Fuse Identifies fuse boxes or their locations


5008 / “OFF”Indicates disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved


5007 / “ON”Indicates connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved


5104 / Start; start of action Identifies the start button

ISO 7010 / Graphical symbols -- Safety colours and safety signs -- Registered safety signs

M002 / Refer to instruction manual / booklet

Indicates that the instruction manual / booklet must be read

ISO 7010 / Graphical symbols -- Safety colours and safety signs -- Registered safety signs

P007 / No access for people with active implanted cardiac devices

Indicates that people with active implanted cardiac devices are prohibited from entering a designated area

ISO 7000 / Graphical symbols for use on equipment 0623 / This way up Indicates the correct upright position of a

package

IP20 IEC 60529 / Degrees of protection provided by enclosures (IP Code)

N/AProtected against solid objects over 12.5mm (e.g., a finger) and no protection against liquids


N/AProtected against solid objects over 12.5mm (e.g., a finger) and protected against vertically falling drops of water or condensation


N/A

Protected against solid objects over 12.5mm (e.g., a finger) and protected against falling drops of water, if the case is disposed at any angle up to 15 degrees from vertical


No specific reference no./ IP Classification

Protected from limited dust ingress. Protected from water spray from any direction, limited ingress protection



No specific reference no./ IP Classification

Protected from limited dust ingress. Protected from water jets from any direction, limited ingress protection

21 CFR 801.109 / Prescription Devices Prescription Device

Indicates that the product is a medical device and Federal Law (USA) restricts this device to sale by or on the order of a physician

Medical Devices Directive 93/42/EEC CE Marking CE marking indicates that a product complies

with applicable European Union regulations

BS EN 50419, Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC (WEEE)

Crossed outwheelie bin

Indicates a product should not be disposed of in a landfill; the black bar indicates that the equipment was manufactured after 2005

Federal Communications Commission FCC Marking

FCC marking indicates the electronic device, which sold in the United States, is certified and the electromagnetic interference from the device is under the limits that are approved by Federal Communications Commission

N/A Cuff Positioning Indicates the correct positioning for the monitor on the wrist

N/A Cuff Positioning Indicates the correct positioning for the monitor on the wrist

or

N/A Artery Marks Types of marks used to indicate the correct positioning of the artery for the upper arm

N/A Cuff positioning Indicator on the cuff for left upper arm

N/A Cuff Indicator Range pointer and brachial artery alignment positioning indicator on the cuff

N/A Cuff Identifier Identifies the type of cuff that is compatible with the blood pressure monitor

N/A Cuff Identifier Identifies the type of cuff that is compatible with the blood pressure monitor

N/A Arm Circumference Range

Indicates the range of arm circumferences to help with selection of the correct cuff size

N/A WarningsVarious warning symbols to indicate a potentially hazardous situation which, if not avoided, could result in death or serious injury

N/AMarking for the position of the replaceable air tube

Indicates the position to insert the air tube

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