Welch Allyn Ear Wash System 29350 - User Manual - Manual (Page 6)

2
Warnings and Symbols
This manual uses the icons and symbols described below.
ATTENTION: Refer to the operating instructions. This symbol is
intended to advise the user of the presence of important oper-
ating or maintenance instructions in the documents accompa-
nying the instrument.
Performance specifications verified by ETL Laboratories
The CE mark on this device indicates that it has been tested
and conforms to the provisions noted within the 93/42/EEC
Medical Device Directive
Authorized European Representative Address:
European Regulatory Manager
Welch Allyn, Ltd.
Navan Business Park
Dublin Road
County Meath, Republic of Ireland
Telephone: 353-46-67700
Fax: 353-46-27128
Only a licensed health care professional or a properly trained per-
son under the direction of such a professional should perform the
irrigation procedure. Always inspect the ear before attempting
any irrigation. Do not irrigate with this device: a) if a perforated
tympanic membrane is documented in the patient’s chart or
observed on inspection, b) if a perforated tympanic membrane is
suspected, or c) if the tympanic membrane cannot be visualized
on inspection. Note that sometimes small perforations are evi-
dent only as an immobile tympanic membrane. Irrigation is not
advised if the patient presents with severe pain, vertigo (espe-
cially with nystagmus), sensorineural hearing loss, active and sig-
nificant bleeding or severe tinnitus. Irrigation in a patient with a
perforated tympanic membrane may result in contaminating the
middle ear with debris from the ear canal. Use clinical discretion
if the patient has acute otitis media, chronic or complicated otitis
media, PE Tubes or is immunocompromised.
If the water is too cold, the patient may experience vertigo or
light-headedness. Please verify that the thermal indicator is white
before proceeding with the irrigation.