
NU OPTIMA PT IS - 1273 rev 0 – 03/12/02 - 15 -
7. Precautions to be taken
The symbol , visible inside door label of the device,
recommends this Operator's Guide should be completely read in
accordance with the EN 60 601-1 Standard.
Fresenius Vial
will not be liable for any damages or claims,
medical or otherwise, of any nature whatsoever, whether direct or
consequential, caused by improper use of this device.
In order to insure that all the safety features of the device are
activated, the pump should be switched ON prior to being
connected to the patient.
Special attention must be paid to the stability of the device. Use the
device in horizontal position, on a table, or with the incorporated clamp
for using on a pole.
Fresenius Vial recommends not to place the pump higher than 1,3
metre above patient.
Container must be placed on a range of 50 cm above the pump ±30
cm.
During all manipulations on the pump or on the set (set installation,
door opening, set removal), make sure the line is closed near to the
injection device with a clamp or a stopcock. If they are not available,
we recommend a back check valve to be assembled on the injection
device in order to avoid any pressure variations which may occur due
to the compliance of the line.
Recommendations to improve performances and safety when the
pump is commonly used at low flow rates (≤20 ml/h) :
Limit the range of available flow rates in accordance with the
maximum flow rate to be used with your protocol (see
configuration menu);
The time to detect a downstream occlusion being conversely
proportional to the flow rate, it is recommended to lower the
pressure limit in order to gain in time to detect an occlusion.
For the infusion of very short half life drugs at flow rate below 5 ml/h,
we recommend the use of syringe pumps which usually offer better
performances of instant flow rates. Check instant flow rate curves and
trumpet curves.
We recommend you partially or completely recharge the battery when
you receive the device or in the case of prolonged storage so as to
prevent all risks of premature discharge.
To preserve the environment, remove the battery from the device prior
to destruction or at the end of the device life and as during normal
maintenance replacement, return it to a competent recycling
organisation. Proceed in the same way for the device itself (electronic
boards, plastics…).
Avoid short circuit and excessive temperature.
Anaesthetic substances: the device must not be used in the presence
of inflammable anaesthetic agents due to the risk of explosion. It
should always be used away from all risk areas.
The device is designed to infuse any medical substance that can be
injected in normal conditions of temperature: +18°/+30°C. The
physiological effects of medicine can be influenced by the
characteristics of the device and the associated disposable
(constitution material is commonly listed on the set packaging). Check
that they are compatible with prescriptions, the characteristics of
trumpet curves and occlusion alarm setting times in relation to the
programmed flow rate.
When using the pump with protocols including refrigerated solution,
check normal temperature of the solution container (+18°/+30°C)
before the installation of the infusion set into the pumping system. This
medical device complies with IEC 60 601-2-24 for environmental
range of use (+ 5°C to + 40°C, 20% to 90% relative humidity) but due
to the range limitation condition of the solution to be infused, we
recommend a normal use condition from + 18°C to + 30°C.
Use only disposable proposed in this Operator’s Guide in accordance
with local standard operating procedures and good clinical practices.
Using non recommended disposable could lead to serious hazards
such as free flow or pump degradation.
After the disposable is primed, check the integrity of the connected
disposable to patient (no leak, no air, especially after the air bubble
sensor).
Fuses should be replaced by equivalent parts. This should be done by a
qualified technician. Refer to the part list of the technical manual for full
specification.
The pump may only be connected to the mains with the power cord
supplied by the manufacturer. Check that the mains voltage corresponds
with the value indicated on the label placed underneath the device.
Do not exceed the permitted voltage on the different external
connections.
The settings parameters which have been modified but not validated by
the users, or the ones which are proposed after the pump has been
switched on may trigger an alarm after a while. The default values
which are then proposed by the pump may vary according to ongoing
status (Start-up, Stop, Infusion). In any case, check the setting
parameters are in accordance with the one you wish.
This device can be disturbed by a strong electromagnetic fields, external
electrical influences and electrostatic discharges above the limits
stipulated by EN 60 601-1-2 and EN 60 601-2-24 (e.g.: mobile phones,
surgical equipment leads close to the pump). It can also be disturbed by
environmental pressure or pressure variations, mechanical shocks, heat
ignition sources, etc.
Standard precautions should be taken to prevent contamination or
injuries while discarding the associate waste disposables (e.g. extension
sets, etc.).
High inline depression may create free flow.
Only use luer lock connection to prevent disconnection due to infusion
pressure.
Make sure that all connection tubes and other infusion devices, that may
be connected to this pump, will resist to a pressure up to 2000 HPa.
Do not use in conjunction with positive pressure infusion devices, that
could generate backpressure higher than 1500 HPa, susceptible to
damage infusion disposables and the device (e.g. contrast fluid
devices).
While in use, negative pressure variation may occur in the line, by the
relative height from the device to the injection site or by combination with
pumping devices such as blood pump, alternative clamp, etc.
Pressure variation may generate flow rates fluctuation mainly noticeable
at low flow rates.
When the reservoir is placed higher than the injection site, please pay
attention to manipulate the set only when it is clamped or disconnected
from patient side.
Make sure that infusion line does not hinder moving parts of other
devices.
Fresenius Vial
recommends the use of one way valves or positive
pressure infusion devices for multi-line infusions. If there is no one way
valve on a gravity infusion line during a multi-line infusion, this will make
it impossible to detect occlusions on the patient side, and could result in
accumulation of the drug being infused in the gravity line, which could
later be infused in an uncontrolled manner when the occlusion is
released. Place the connection between the gravity line and the pump-
driver line as near to the start of the set as possible in order to minimise
the dead space and consequently the impact of any change in flow rate
on the gravity line.
One way
valve
Solution container
Infusion pump
All computer systems connected to the RS 232 link on the base must
meet the safety features, as in the IEC 950 standard for computer
interfaces.
Fresenius Vial
will not be responsible whatsoever for use of any
interface communication between the Optima pump and computer
systems.
Opening the pump or the battery cover must only be carried out by the
qualified personnel in your establishment, and taking all the necessary
technical precautions. Non-respect of these procedures is dangerous to
the personnel and may damage the pump. We recommend you follow
the maintenance procedures defined in the Technical Manual. To obtain
a copy of the Technical Manual, please contact our After-Sales
Department specifying the identification number of the device.