Packaging Symbols; Intended Use; Indication; Contraindication - Riester ri-former Gebrauchsanweisung

REF
Reference number
°C °F Temperature for transport and storage condition
Relative Humidity for transport and storage condition
Air pressure for transport and storage
Air pressure for Ambient Operating
CE Mark
Symbol for the marking of electrical and electronics de-
vices according to Directive 2002/96/EC.
Non-ionizing radiation
Max.
Maximum weight of the basket can bear
< 1,5 kg
Final maximum weight of whole device including mobile
Mass
stand, ri-former Diagnostic Station, big-ben and basket
®
13 kg
bear and basket bear the max. weight.

1.3. Packaging Symbols

Symbol Symbol Note
Fragile. Show transport package contents fragile, so hand-
ling should be handled with care.
Beware the package from getting wet.
Upward. It shows the correct position to transport the
package.
Keep away from sunlight
„Grüner Punkt" (country-specific)
The device satisfies the requirements for electromagnetic compatibility.
Please note that under the influence of unfavorable field strengths, e.g. du-
ring the operation of wireless telephones or radiological instruments, adver-
se effects on function cannot be excluded.
The electromagnetic compatibility of this device has been verified by test ac-
cording to the IEC 60601-1-2 requirements
1.4

Intended Use

The ri-former Diagnostic Station was manufactured for use with vari-
®
ous instrument heads and modular components for non-invasive
diagnostics.

1.4.1 Indication

The ri-former Diagnostic Station supplies the different instrument
®
heads and modular components with energy.
The various instruments, extension modules connected to the diagno-
stic Station, serve the trained physician or specialist as an aid in the
detection, diagnosis, monitoring, treatment o. Alleviation of illnesses,
injuries or disabilities.

1.4.2 Contraindication

The device is not designed, sold, or intended for use except as indicated.

1.4.3 Intended patient population

The device is intended for all patients.

1.4.4 Intended operators / users

The device could be used by a doctor, nurse in hospitals, medical facili-
ties, clinics, doctors' offices. No use in MR environment!

1.4.5 Required skills / training of operators

The operators have the appropriate qualification for the use of this dia-
gnostic tool. All connectors and connections are clearly explained in the
instructions for use.
The user must comply exactly with the instructions in the instructions
for use.

1.4.6 Environmental conditions

The device is determined to be used in a controlled environment .
The device must not be exposed to harsh / rough environmental con-
ditions.
1.5

Warnings / Attention

Warnings!:
The general warning sign indicates a potentially hazardous
situation which could result in serious injury.
No use in MR environment!
There is a possible danger of inflammation of gases if the
device is operated in the presence of inflammatory mixtures
or mixtures of pharmaceuticals and air or oxygen or laug-
hing gas!
/
The appliance shall not be operated in premises where in-
flammatory mixtures or mixtures of pharmaceuticals and
air or oxygen or laughing gas are present, e.g. Operating
rooms.
Electric shock!
The ri-former Diagnostic Station housing may only be
®
opened by authorized persons
Damage to the device due to falling, or to high ESD influ-
ence!
If the device has no function, it must be returned to the ma-
nufacturer for repair.
The device is to determine to be used in a controlled en-
vironment.
The device must not be exposed to harsh / rough environ-
mental conditions.
Using the Otoskope to a new earspecula.
A maximum of 2 handles may be used at the same time,
otherwise the wide-range power supply may be overloaded.
- Disposable ear specula
Only use new ear specula to limit the risk of cross conta-
mination.
-Reusable ear specula
Only use cleaned / sterilized ear specula to limit the risk of
cross contamination.
To limit the risk of cross-contamination, only use a cleaned,
disinfected nasal specula.
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