2
EN
EN
3
/ ViVi
®
Helmet
/ ViVi
®
Helmet
© THI GmbH 2018/09
REF 20602 | Rev-03
INTRODUCTION
This
Instructions For Use manual
is the most comprehensive source of informa-
tion for the safe and eff ective use of your product. This manual may be used by
in-service trainers, physicians, nurses, surgical technologists, and biomedical
equipment technicians.
Keep and consult this reference manual during the life of the product.
THE FOLLOWING CONVENTIONS ARE USED IN THIS MANUAL:
WARNING
A
WARNING
highlights a safety-related issue.
ALWAYS
comply with this information to prevent patient and/or
healthcare staff injury.
CAUTION
A
CAUTION
highlights a product reliability issue.
ALWAYS
comply with this information to prevent product damage.
NOTE
A
NOTE
supplements and/or clarifi es procedural informa-
tion.
If additional information, especially safety information, or in-service training is
required, contact your distributor.
Trademarks not the property of THI GmbH are the property of their respective
owners.
COMPLIANCE STATEMENTS
MEDICAL DEVICE ACC. DIRECTIVE 93/42/EEC
PERSONAL PROTECTIVE EQUIPMENT ACC. REGULATION (EU)
2016/425
In combination with
ViVi
®
Hood (REF 80200) or
ViVi
®
Toga (REF 80220,
80221, 80222), this device is part of a PPE system. This device has been EC-
type examined by the following notifi ed body:
CERTOTTICA S.C.R.L.
, Z.I.
Villanova 32013 Longarone (BL) Italy, (Code 0530)
To download the declaration of conformity please visit:
www.thigmbh.at
MARKING DEFINITIONS - THI EN166 3 F
CODE
DEFINITION
THI
Code of Manufacturer - THI GmbH
EN166
European Standard – Personal Eye Protection Specifi cation
- EN 166:2001
3
Field of use - against splashes of liquids
F
Mechanical Strength - resistance against higspeed particles
– low energy 45 m/s
INDICATIONS FOR USE
The
ViVi
®
Helmets are surgical devices that pull in and circulate fresh air
throughout the helmet to aid user comfort.
ViVi
®
Helmets are multiple-use
devices, which are worn by healthcare professionals in the operating room
during surgery.
CONTRAINDICATIONS
None known.
LIMITATIONS OF USE
WARNINGS:
•
The surgical helmets are not intended to be used as a respiratory protec-
tion device.
•
The materials contained within this device are not known allergens. However, if
an allergic reaction occurs, contact a physician.
FOR USE WITH
•
Rechargeable Battery Pack. See
Accessories
section
DESCRIPTION
In addition to pulling in, pushing out and circulating fresh air throughout the
surgical helmet, the helmet stabilizes the face-shield of a surgical gown for
user comfort.
USER/PATIENT SAFETY
WARNINGS:
•
Before using any component, or any component compatible with this
equipment, read and understand the instructions. Pay special attention to
WARNING
information. Become familiar with the components prior to use.
•
Only trained and experienced healthcare professionals should use this
equipment.
•
Upon initial receipt and before each use, operate the equipment and in-
spect each component for damage.
•
DO NOT use any equipment if damage is apparent or the inspection criteria
are not met. See the Inspection and Testing section for inspection criteria.
•
The healthcare professional performing any procedure is responsible for
determining the appropriateness of this equipment and the specifi c tech-
nique used for each patient. THI GmbH, as a manufacturer, does not rec-
ommend surgical procedure or technique.
•
DO NOT use this equipment in areas in which fl ammable anesthetics or
fl ammable agents are mixed with air, oxygen or nitrous oxide.
•
Take special precautions regarding electromagnetic compatibility (EMC)
when using medical electrical equipment like the
ViVi
®
Helmet. Install
and place the helmet into service according to the EMC information in this
manual. Portable and mobile RF communications equipment, such as wire-
less phones, can aff ect the function of the helmet. See the Specifi cations
section.
SYMBOL DEFINITIONS
The symbols located on the equipment and/or labeling are defi ned in this sec-
tion.
SYMBOL
DEFINITION
Caution, consult accompanying documents
Waste Electrical and Electronic Equipment Directive
(WEEE)
Li-ion
Recyclable Product
Headlight ON/OFF
Temperature Limitation
%
Humidity Limitation
Consult Instructions for Use
Direct Current (DC)
Hook-and-loop attachment points
Beep
Acoustic Signal
Manufacturer
Non-ionizing electromagnetic radiation
CE Mark
Catalog number
Serial number
