26 | Espire Elbow Technical Manual - Classic Plus, Classic and Basic
Definitions of symbols used in and on this device
and packaging
Symbol
Definition
Source
Consult instructions for use.
BS EN ISO
15223-1: 2012
Reference no.
5.4.3
Keep dry.
BS EN ISO
15223-1: 2012
Reference no.
5.3.4
This product contains electrical and
electronic components that may
contain materials which, if disposed
with general waste, could be damaging
to the environment. Residents of the
European Union must follow specific
disposal or recycling instructions
for this product. Residents outside
the European Union must dispose or
recycle this product in accordance with
local laws or regulations that apply.
IS EN
50419:2006
Reference no.
Fig. 1
Caution: Federal (USA) law restricts this
device to sale by or on the order of a
physician.
USA Code
of Federal
Regulations
21 CFR Part 801
§ 801.109(b)(1)
Refer to instruction manual/booklet.
IEC TR 60878
Ed. 3.0 b:2015
Symbol
Definition
Source
The requirements for accreditation
and market surveillance relating to the
marketing of products; Medical Device
Directive.
765/2008/EC
768/2008/EC
MDD 93/42/
EEC Articles
4,11,12,17, Annex
II )
Temperature limit.
ISO 15223-1
Reference no.
5.3.7
Storage humidity range.
ISO 15223-1
Reference no.
5.3.8
Protection against solid foreign objects
of 12.5 mm diameter and greater, and
protection against vertically falling
water drops when tilted up to 15
degrees.
IEC 60601-
1, Table D.3,
Symbol 2
Medical device manufacturer.
ISO 15223-1,
Clause 5.1.1
China RoHS Mark I logo. Product
does not contain toxic and hazardous
substances or elements above the
clip level in any material or application
including those exempt from the
requirements of the EU RoHS Directive.
SJ/T11364-
2006
Subject to recycling under the Waste
Disposal Act.
Environmental
Protection
Administration,
R.O.C.(Taiwan)
Note: Possible technical damage.
Additional Notes
Symbol
Definition
Source
Info: Basic information regarding this
product.
Caution: Possible risk of accident or
injury.
Warning: Possible risk of severe
accident or injury.
Indicates that this item is a medical
device
MD
