Tuttnauer TIVA8-MD, Инструкция по эксплуатации

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7
Operative Instructions
a program (USER PIN MANAGEMENT option on
request).
•
SUPER USER:
Is the user that has special access to the
device's menu for extra settings.
•
SERVICE PERSONNEL:
The person(s) in charge
of installing, operating, adjusting, maintaining,
cleaning, repairing and transporting the machine.
Can perform every operation concerning machine
positioning at the User's premises, the connection
of different systems, machine commissioning, the
routine and special maintenance and the repairs
that require special knowledge of the machine.
The service personnel is also able to recognize the
dangers deriving from incorrect or improper use
of the machine itself and to proceed with the final
demolition of the machine.
Before proceeding with the various operations, the
above listed operators, must have carefully read and
become familiar with this manual.
The washer disinfector packaging, in addition to the
machine's documentations, contains the two spray
arms that will be applied on the chamber, the flexible
hoses for the hydraulic connections the drain pipe, the
supply wire, the emergency release key and the USB
key.
Upon delivery, check that the washer disinfector is
intact and that the above-described material is actually
present.
For the installation, wiring and hydraulic diagrams
(water filling and draining) contact the manufacturer.
2.5 Product analysis
The washer disinfector was tested by applying «UL
61010-1 CAN/CSA-C22.2 61010-1-12 IEC 61010-2-
010 61010-2-040 Safety requirements for electrical
equipment for measurement, control, and laboratory
use Part 2-040 Particular requirements for sterilizers
and washer disinfectors used to treat medical
materials», where the machine is expected to:
• use with a primary voltage fluctuation up to ±10%
compared to the nominal voltage;
• use with a temporary type overvoltages:
- of short duration, which may occur between the line
conductor and the system earthing, which may have
a voltage equal to the power supply voltage on the
line-n1200V, and a duration up to 5s;
- of long duration which may occur between the line
conductor and the system earthing, which may have a
voltage equal to the power supply voltage on the line-
n250V, and a duration greater than 5s;
- overvoltage category II;
- pollution degree 2.
• The validation of the product was made by the
manufacturer in compliance with standard ISO 15883.
• The machine does not cause harmful vibrations.
• The residual radiation emitted within the limits is
non-ionizing.
• The shelf life cycle of the device is 10 years.
• The machine must not be dumped when scrapped,
as it contains materials subject to legislation requiring
disposal at special centres.
2.5.1 Inlet water quality
The quality of the water used in all stages of cleaning is
important for good results.
The water used in each stage must be compatible with:
• The material which the machine is made of.
• The chemicals used in the process.
• Process requirements for the various stages of the
process.
The main factors for good inlet water quality in relation
to the effectiveness of washing are:
HARDNESS
The high hardness of the water generates a detergent
inactivation, reducing its efficacy. It also causes
limescale deposits in the machine, jeopardizing the
cleanliness of the instruments and the machine,
especially on hot parts (ex. heating elements).
IONIC CONTAMINANTS
A high concentration of ionic contaminants may cause
corrosion of steel, manganese or copper instruments.
MICROBIAL CONTAMINANTS
Microbial contaminants can increase the microbial
contamination of the instruments at the end of the
wash.
The manufacturer therefore recommends that:
- the water used in the pre-rinse and washing stage
should be of drinking quality according to the
“Guidelines for drinking-water quality, 4th edition”
published by the WHO.
- deionized water is used for the rinsing and
disinfection. A typical specification for deionized
water is:
Ion concentration H+ 4.5…7 pH
Conductivity < 30 μs/cm
TDS < 40 mg/l
Maximum hardness (CaCO
3
) < 10 mg/l
Chlorine < 10 mg/l
Heavy metals < 10 mg/l
Phosphates < 0.2 mg/l as P
2
O
5
Silicates < 0.2 mg/l as SiO
2
Endotoxins < 0.25 EU/ml