Explanation of Symbols Used
General Symbols
Caution (Ref. 5.4.4 ISO 15223-1)
Consult Instructions For Use
(Ref. 5.4.3 ISO 15223-1)
Manufacturer and Date of Manufacture
(Ref. 5.1.1 ISO 15223-1)
Date of Manufacture (Ref. 5.1.3 ISO 15223-1)
Reference or Catalogue Number
(Ref. 5.1.6 ISO 15223-1)
Serial Number (Ref. 5.1.7 ISO 15223-1)
Lot or Batch Number (Ref. 5.1.5 ISO 15223-1)
Packaging unit, indicates the number of
pieces in the package (Ref. 2794 ISO 7000)
Non-sterile (Ref. 5.2.7 ISO 15223-1)
Materials
Medical Device in the European Community/
Union
Authorized Representative in the European
Community (Ref. 5.1.2 ISO 15223-1)
CE marking of conformity in European
Community with identification of notified body
(Regulation (EU) 2017/745)
CE marking of conformity in European
Community (Regulation (EU) 2017/745)
Use-by Date (Ref. 5.1.4 ISO 15223-1)
Keep away from sunlight
(Ref. 5.3.2 ISO 15223-1)
Keep dry
(Ref. 5.3.4 ISO 15223-1)
Sterilized using irradiation
(Ref. 5.2.4 ISO 15223-1)
Do not use if package is damaged
(Ref. 5.2.8 ISO 15223-1)
Do not re-use (Ref. 5.4.2 ISO 15223-1)
Caution: United States Federal law
restricts this device to sale by or on the
order of a physician or other licensed
healthcare provider (21 CFR 801.109)
Made in
Quantity, indicates the number of pieces
in the package
Type BF applied part complying with
IEC 60601-1 (Ref. 5333 IEC 60417)
Do not immerse device in liquids
Duty Cycle type according IEC 60034-1
Water ingress protection rating according
IEC 60529
Product is UL Classified to the require-
ments of both the United States and
Canada
Separate collection (EN 50419)
Indicates Environment-Friendly Use Period
of 10 years in China (SJ/T 11364)
Temperature Limit
(Ref. ISO 5.3.7 ISO 15223-1)
Humidity Limitation
(Ref. ISO 5.3.8 ISO 15223-1)
Atmospheric Pressure Limitation
(Ref. ISO 5.3.9 ISO 15223-1)
Non-ionizing electromagnetic radiation
(Ref. 5140 IEC TR 60878): Interference
may occur in the vicinity of equipment
marked with the following symbol
(IEC 60601-1-2, clause 5.1.1)
S9
IPX4, IPX6,
IPX8 and IPX9
Qty
EC REP
10PB
52
Instruction for Use • UNIUM
™
