5
Operative Instructions
2.1 Field of application
This machine, intended for washing and disinfecting,
is considered a class IIb medical device (as defined by
Directive 93/42/EEC class IIb).
Follow the instructions of the instrument manufacturers
(according to EN ISO 17664), as well as the national laws
and directives for the automatic treatment of medical
devices. The personnel in charge using the machine
daily must be aware of its main features, and must also
receive adequate and continuous training.
2.1.1 Intended use
The washer disinfector is designed for the needs of
cleaning and disinfecting non active and active surgical
instruments, whose manufacturers expressly state that
they can be treated in the machine.
Non active surgical instruments, such as:
- dental instruments;
- instruments for surgery and minimally invasive
surgery (MIS);
- anesthesia and intensive care instruments;
- surgical instruments for ophthalmology;
- instruments for arthroscopy and rectoscopy (except
for flexible endoscopes);
- instruments for ear, nose and throat surgery;
- instruments for gynaecology and urology;
- baby bottles and teats;
- ward end utensils such as kidney dishes, bowls and
OP shoes.
Active surgical instruments, such as:
- Da Vinci arms.
2.1.2 Intended users
Specialized personnel capable of working in a CSSD,
Dental clinics and Hospital’s disinfection area.
2.1.3 Intended use of environment
The machine is intended to be used only for internal
uses. The machine is designed to be operational up
to a maximum altitude of 6562 ft (2000 meters), at a
temperature between 41 and 104°F (5 and 40°C) and
used in an environment with a maximum humidity of
80% for temperatures up to 88°F (31°C), decreasing
linearly to 50% at 104°F (40°C).
2.2 Label specifications
The washer disinfector is equipped with an identification
label (for position see Fig. 2). The following table shows
the symbols used on the identification labels:
Symbol
Description
Manufacturer of the device.
Symbol
Description
Date of manufacture of the device.
Device serial number from the
manufacturer.
Model name of the device.
Indicates the permitted temperatu-
re range (min./max.) of the water
supply.
Flow pressure on the water inlet
connected from min. to max.
The user manual includes important
safety information. Failure to comply
with these instructions can result in
injury and material damage. Please
read carefully the User Manual.
For indoor use only.
Keep away from sunlight.
Keep dry.
Please read this user manual
carefully before commissioning the
device.
The product complies with UL safety
standards valid for both Canada and
the USA.
For the disposal of the machine
please refer to chapter "Equipment
Disposal".
2.3 Warranty
The manufacturer warrants the newly manufactured
product for 12 (twelve) months from the date of the
invoice of the Products unless specifically provided
otherwise in the Contract or Order Confirmation.
Within the aforementioned terms, the manufacturer
will supply free of charge any part which, at its sole
discretion, or of its authorized representative, shows
manufacturing defects, or at its discretion, carries out
repairs directly or through authorized personnel. In
any case, labor costs for replacing defective parts are
always charged to the Customer.
- The right of warranty services it is only recognized if,
once the defect is found, it is immediately reported
to the manufacturer, at the same time sending the
Summary of Contents for TIVA8-MD
Page 56: ...56 Operative Instructions Notes...
Page 57: ...57 Operative Instructions Notes...
Page 58: ...58 Operative Instructions Notes...
Page 59: ...59 Operative Instructions...
