Combination With Medical Electrical Equipment; Inspections; First Use - Aesculap PV481 Instrucciones De Manejo

Danger of explosion from a device that is improp-
erly set up!
►
WARNING Make certain that the power plug is connected
to the power supply outside of any areas where
there is a risk of explosion.
►
Do not use the product in potentially explosive
areas or close to highly flammable or explosive
gases (e.g. oxygen, anesthetic gases).
Risk to patient and user due to condensation and
short-circuit!
►
Before putting into operation make sure that all
WARNING
components used have enough time to adjust to
the changed environmental conditions.
Risk of injury to the eyes!
►
Do not insert the light guide into the light
WARNING source during the check of the fibers.
Risk of infection and injury!
►
Do not use products with damaged fiber optics,
WARNING damaged glass surfaces or stubborn deposits
which cannot be removed by cleaning.
Risk to patient due to use of damaged products!
►
Do not use products if they have sharp edges or
WARNING other hazardous surface damage.
Risk to persons and risk of damage to equipment
due to improper cable routing!
►
Lay all cables and leads so that they do not pres-
CAUTION
ent a tripping hazard.
►
Do not place objects on the cables.
Risk to patient due to poor/lack of vision!
►
Adjust the monitors and display elements so
that they are highly visible to the user.
CAUTION
Interference of high frequency energy with the
device!
►
CAUTION Do not use any mobile or portable equipment
that emit high-frequency energy (e.g. mobile
phones, cell phones, GSM phones) in the vicinity
of the product.
Note
The product including the camera cable is fragile when bent, kinked,
twisted, pulled, or pressed.
Note
Handle the camera head and camera cable with care. Do not exert any
mechanical forces and avoid mechanical impacts.
Note
Connect the equipotential bonding terminals of all equipment used with
the equipotential bonding strip see IEC 60601-1-1 / EN 60601-1-1 or in
accordance with national standards.
Note
Ensure that the corresponding interconnection conditions, standards and
respective national deviations are observed.
4.1

Combination with medical electrical equipment

The product can be combined with components from other manufacturers
provided that all components are compliant with the medical electrical
equipment safety requirements according to IEC 60601-1.
It is the operator's responsibility to check and make sure that the system
is and remains fully operational.
When using devices from different manufacturers and when operating an
endoscope and/or endoscopic accessories together with medical electrical
equipment, it must be ensured that the applied part is properly isolated:
Type CF, defibrillation-proof.
4.2

Inspections

Carry out the following inspection steps before reprocessing and immedi-
ately before use of the device:
Inspection of the glass surfaces
►
Before each use, inspect the camera head for damage such as rough
surfaces, sharp edges or protrusions to avoid injuries to the patient.
►
Perform a visual inspection of the glass surfaces. The surfaces must be
clean and smooth.
If there are impairments/damage, see Troubleshooting list.
4.3

First use

Risk of injury and/or product malfunction due to
incorrect operation of the medical electrical sys-
tem!
WARNING
►
Follow the instructions for use of all products
required.
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