THI ViVi 80100 Bedienungsanleitung Seite 2

2
EN
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
ViVi
In combination with ® Hood (REF 80200) or
80221, 80222), this device is part of a PPE system. This device has been EC-
type examined by the following notifi ed body:
Villanova 32013 Longarone (BL) Italy, (Code 0530)
To download the declaration of conformity please visit:
MARKING DEFINITIONS - THI EN166 3 F
CODE DEFINITION
THI Code of Manufacturer - THI GmbH
European Standard – Personal Eye Protection Specifi cation
EN166
- EN 166:2001
3
Field of use - against splashes of liquids
Mechanical Strength - resistance against higspeed particles
F
– low energy 45 m/s
INDICATIONS FOR USE
ViVi ®
The Helmets are surgical devices that pull in and circulate fresh air
throughout the helmet to aid user comfort.
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.
REF 20602 | Rev-03
ViVi
® Toga (REF 80220,
CERTOTTICA S.C.R.L.
, Z.I.
www.thigmbh.at
ViVi
® Helmets are multiple-use
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
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)
Recyclable Product
Li-ion
Headlight ON/OFF
Temperature Limitation
%
Humidity Limitation
Consult Instructions for Use
Direct Current (DC)
Hook-and-loop attachment points
Acoustic Signal
Beep
Manufacturer
Non-ionizing electromagnetic radiation
CE Mark
Catalog number
Serial number
/ ViVi Helmet
®
ViVi
® Helmet. Install
© THI GmbH 2018/09