Riester ri-derma Otoscopio Diagnostic Instruments Instructions
- October 30, 2023
- Riester
Table of Contents
- Riester ri-derma Otoscopio Diagnostic
- Important information to observe prior to initial use
- Safety instructions
- Battery handles and startup
- Commissioning (inserting and removing batteries and rechargeable
- Charging the battery handles with rechargeable batteries
- Fitting instrument heads
- ri-scope®L otoscope
- ri-scope®L ophthalmoscopes
- Slit and spot retinoscopes
- Dermatoscope
- Bent-arm illuminator
- Nasal speculum
- Tongue depressor
- Laryngeal mirror
- Operation otoscope for veterinary medicine
- Replacing the lamp Otoscope L1
- Care instructions
- Spare parts and accessories
- Maintenance
- Instructions
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
Riester ri-derma Otoscopio Diagnostic
Important information to observe prior to initial use
You have purchased a high quality Riester diagnostic instrument set manufactured in compliance with Directive 93/42/EEC for medical devices and subject to stringent quality control procedures at all stages. The excellent quality guarantees you reliable diagnoses. The use of the Riester battery handle for the ri-scope® and riderma instrument heads and their accessories is de-scribed in our Operating Instructions. Please read the Operating Instructions carefully before initial use and retain them for future reference. Should you have any questions, we or the representative responsible for Riester products are available for you at all times. Please find our address on the last page of these Operating Instructions. We would be pleased to provide you with the address of our representative on request. Please note that at the instruments described in these Operating Instructions are exclusively suitable for use by properly trained persons. The operation otoscope in the Vet-I instrument set is an instrument exclusively produced for veterinary medicine and therefore bears no CE mark. Please also note that the faultless and safe function of our instruments can only be ensured if the instruments as well as their accessories used are exclusively from Riester.
Warning:
The use of other accessories may result in increased electromagnetic emissions
or reduced electromagnetic immunity of the device and may lead to incorrect
operation.
Caution / Contraindications
- There may be the danger of ignition of gases when the instrument is in the presence of combustible mixtures or mixtures of pharmaceuticals.
- The instrument heads and battery handles must never be placed in liquids. – In the case of a longer eye examination with the ophthalmoscope, the inten- sive exposure to light can damage the retina.
- The product and the ear specula are non-sterile. Do not use on injured tis- sue.
- Use new or sanitized specula to limit the risk of cross-contamination.
- The disposal of used ear specula must occur in accordance with current medical practices or local regulations regarding the disposal of infectious, biological medical waste.
- Only use accessories / consumables from Riester or Riester-approved ac- cessories / consumables.
- Cleaning frequency and sequence must comply with regulations on the cleaning of non-sterile products in their respective facility. Cleaning / disinfection instructions in the operating manual must be observed.
- The product may only be used by trained personnel.
Safety instructions
CE marking
Temperature limits
in °C for storage and transport
Temperature limits
in °F for storage and transport
Relative humidity
Fragile, handle with care
Store in a dry place
„Green Dot“ (country-specific)
Warning, this symbol indicates a potentially dangerous situation. Device of protection class II
Application part type B
Attention: Used electrical and electronic equipment should not be tre-ated as normal household waste but should be disposed of separately in accordance with national or EU directives
Batch code
Serial number
Please observe the operating instructions
For single use only
Battery handles and startup
Purpose / indication
The Riester battery handles described in this manual are used to power the
instrument heads (the lamps are incorporated into the corresponding instrument
heads). They also serve as a receptacle.
Battery handles in conjunction with plug-in charger for ri-accu® L
Battery handle range
All instrument heads described in this manual fit the following battery
handles and can therefore be combined individually. All instrument heads also
fit on the handles of the wall model ri-former®.
ATTENTION!
LED instrument heads are only compatible with a specific serial number of the
ri-former® diagnostic station. Information about the compatibility of your
diagnostic station is available on request.
Battery handle type C with rheotronic® 2.5 V
To operate these battery handles, you need 2 standard alkaline batteries
type C Baby (IEC standard LR14) or a ri-accu® 2.5 V. The handle with the ri-
accu® from Riester can only be charged in the Riester ri-charger® charger.
Battery handle type C with rheotronic® 3.5 V (for ri-charger® L)
To operate this battery handle you will need:
- 1 rechargeable battery from Riester with 3.5 V (art. no. 10691 ri-accu® L).
- 1 charger ri-charger® L (art. no. 10705, art. no. 10706)
Battery handle type C with rheotronic® 3.5
For charging in the wall socket 230 V or 120 V
To operate this socket handle you will need:
1 rechargeable battery from Riester with 3.5 V (art. no. 10692 ri-accu® L)
Battery handle type C with rheotronic® 3.5 V (for plug-in charger)
To operate this battery handle you will need:
- 1 rechargeable battery from Riester with 3.5 V (art. no. 10694 ri-accu® L).
- 1 Plug-in charger (art. no. 10707)
New ri-accu®USB
art. no. 10704
Battery handle type C with rheotronic® 3.5V and with ri-accu®USB charging
technology includes:
- 1 rechargeable battery from Riester with 3.5 V (art. no. 10699 ri-accu®USB)
- 1 handle type C Rheotronik
- 1 USB cabel Typ C, charging is possible with any DIN EN 60950 /DIN EN 62368-1 compliant USB source without patient contact (2 MOOP). Riester offers an optional medically approved power supply under art. no. 10709.
Function:
Instrument head with battery handle type C and ri-accu®USB is ready for use
during charging.
It can therefore be used during a patient examination while it is charging.
ATTENTION!
Takes place during charging (battery handle type C with USB charging
technology art. no. 10704), if the medical power supply of Riester art. no.
10709 is used, since this ME system is tested in accordance with standard IEC
60601-1: 2005 (Third Edition) + CORR. 1:2006 + CORR. 2: 2007 + A1: 2012 and is
medically approved.
This ri-accu®USB has a charge status indicator.
LED is green: – Battery is fully charged.
LED flashes green: – Battery is being charged.
LED is orange: – Battery is too weak and must be charged.
Specifications
18650 Li-ion Battery, 3.6 V 2600 mAh 9.62 Wh
Ambient temperature: 0° to +40°
Relative humidity: 30 % to 70 % non-condensing
Transport and storage temperature: -10 ° to +55 °
Relative humidity: 10 % to 95 % non-condensing
Air pressure: 800 hPa – 1100 hPa
Operating environment:
The ri-accu®USB is used exclusively by professional users in clinics and
medical practices.
Battery handle type AA with rheotronic® 2.5 V
To operate these battery handles, you need 2 standard alkaline batteries type
AA (IEC standard LR6)
Battery handle type C with rheotronic® 3.5 V (for ri-charger® L)
To operate this battery handle you will need:
- 1 rechargeable battery from Riester with 3.5 V (art. no. 10694 ri-accu® L).
- 1 charger ri-charger® L (art. no. 10705, art. no. 10706)
Commissioning (inserting and removing batteries and rechargeable
batteries)
ATTENTION!
Use only the combinations described under 2.3 to 2.8!
Inserting the batteries:
Battery handles (2.3 and 2.7) type C and AA with rheotronic® 2.5 V:
- Unscrew the battery handle cover on the lower part of the handle in a counter clockwise direction.
- Insert the standard alkaline batteries designated for this battery handle with the plus side in the direction of the handle top into the battery handle.
- Screw the battery handle cover firmly back onto the battery handle.
Removing the batteries:
Battery handles (2.3 and 2.7) type C and AA with rheotronic® 2.5 V:
- Unscrew the battery handle cover on the lower part of the battery handle in a counter clockwise direction.
- Remove the batteries from the battery handle by holding the opening of the battery handle slightly downwards and shaking it slightly if necessary.
- Screw the battery handle cover firmly back onto the battery handle.
ATTENTION!
For all factory-installed or separately supplied batteries, the red safety
foil on the plus side must be removed before startup!
ATTENTION!
Only applies to battery handle (2.5) type C with rheotronic® 3.5 V for
charging in the 230 V or 120 V socket:
When using the new ri-accu® L art. no. 10692, make sure that there is no
insulation on the spring of the battery grip cover. When using the old ri-
accu® L art. no. 10692, insulation must be attached to the spring (danger of
short circuit!).
Inserting the batteries:
Battery handles (2.4 and 2.8) type C and AA with rheotronic® 3.5 V (for ri-
charger® L).
Battery handle type C with rheotronic® 3.5 V (for plug-in charger)
Battery handle (2.5) type C with rheotronic® 3.5 V for charging in the socket
230 V or 120 V.
ATTENTION!
Please observe safety instructions!
- Unscrew the battery handle cover on the lower part of the handle in a counter clockwise direction.
- Remove the red safety foil on the plus side of the battery during initial startup.
- Insert the battery approved for your battery handle (see 2.2) into the battery handle with the plus side in the direction of the handle top. In addition to the plus sign you will also find an arrow that shows you the direction of insertion into the battery handle.
- Screw the battery handle cover firmly back onto the battery handle.
Removing the batteries:
Battery handles (2.4 and 2.8) type C and AA with rheotronic® 3.5 V (for ri-
charger® L).
Battery handle type C with rheotronic® 3.5 V (for plug-in charger)
Battery handle (2.5) type C with rheotronic® 3.5 V for charging in the socket
230 V or 120 V.
ATTENTION!
Please observe safety instructions!
- Unscrew the battery handle cover on the lower part of the battery handle in a counter clockwise direction.
- Remove the batteries from the battery handle by holding the opening of the battery handle slightly downwards and shaking it slightly if necessary.
- Screw the battery handle cover firmly back onto the battery handle.
Charging the battery handles with rechargeable batteries
Battery handles (2.4 and 2.8) type C and AA with rheotronic® 3.5 V (for ri- charger® L).
- Can only be used in the charger ri-charger® L (art. no. 10705, art. no. 10706) from Riester.
- The ri-charger® L charger comes with an additional user manual that must be observed.
Battery handle type C with rheotronic® 3.5 V (for plug-in charger)
It can only be used with the plug-in charger (art. no. 10707) from Riester..
For this purpose, the small round plug is inserted into the lower part of the
battery handle through the opening in the battery handle cover in the battery
(art. no. 10694 ri-accu® L).
Now connect the mains plug of the plug-in charger to the power supply. The
charge status of the battery is indicated via the LED on the plug-in charger.
Red light means charging, green light means that the battery is fully charged.
Battery handle (2.5) type C with rheotronic® 3.5 V for charging in the 230
V or 120 V socket.
Unscrew the bottom part of the socket handle counter clockwise. The socket
contacts will become visible. Round contacts are for 230 V mains operation,
flat contacts are for 120 V mains operation. Now plug the handle base into the
socket for charging.
ATTENTION!
- Before using the socket handle for the first time, it should be plugged into the socket up to a max. of 24 hours.
- The socket handle must not be charged for more than 24 hours.
- The handle must never be in the socket when replacing the battery!
Technical specifications:
230 V or 120 V version options
ATTENTION
- If you do not use the device for a long time or take it with you while traveling, please remove the batteries and rechargeable batteries from the handle.
- New batteries should be inserted when the light intensity of the instrument becomes weaker.
- In order to obtain an optimal light yield, we recommend that you always insert new high-quality batteries when changing the battery (as described in 3.1 and 3.2).
- If there is a suspicion that liquid or condensation has penetrated the handle, it must not be charged under any circumstances.
- This can lead to a life-threatening electric shock especially with regard to the socket handles.
- To extend the battery life, the battery should not be charged until the light intensity of the instrument becomes weaker.
Waste disposal:
Please note that batteries and rechargeable batteries must be disposed of as
special waste. You can obtain the relevant information from your local
authority or from your local environmental advisor.
Fitting instrument heads
Fit the required instrument head on the receptacle on the upper part of the handle such that the two recesses of the lower part of the instrument head fit on the two protruding guide studs on the battery handle. Press the instrument head lightly on to the battery handle and screw the handle clockwise as far as it goes. The head is removed by screwing counter clockwise.
Switching Type C and AA battery handles on and off
Activate the instrument by turning the switching ring on the top of the handle
clockwise direction. To switch off the instrument turn the ring anti-clockwise
direction until the device is swithced-off.
rheotronic® for adjusting the light intensity
With the rheotronic it is possible to modulate the light intensity for the C
and AA handles. Depending on how often you turn the switching ring clockwise
or anti-clockwise direction, the light intensity is stronger or weaker.
ATTENTION!
At every switch-on of the battery handle the light intensity is at 100%
Automatic safety switch-off after 180 seconds.
Explanation of the symbol on the plug-in handle:
ATTENTION!
Observe the Operating Instructions!
ri-scope®L otoscope
Purpose
The Riester otoscope described in these Operating Instructions is produced
for illumination and examination of the auditory canal in combination with
Riester ear specula.
Fitting and removing ear specula
Either Riester disposable ear specula (blue colour) or reusable Riester ear
specula (black colour) can be fitted to the otoscope head. The size of the ear
specula is marked at the back of the speculum.
L1 and L2 otoscopes
Screw the speculum clockwise until noticeable resistance is felt. To remove
the speculum, screw the speculum counter clockwise.
L3 otoscope
Fit the chosen speculum on the chrome-plated metal fixture of the otoscope
until it locks into place. To remove the speculum, press the blue ejection
button. The speculum is automatically ejected.
Swivel lens for magnification
The swivel lens is fixed to the device and can be swivelled 360°.
Insertion of external instruments into the ear
If you wish to insert external instruments into the ear (e.g. tweezers), you
have to rotate the swivel lens (approx. 3-fold magnification) located on the
otoscope head by 180°. Now you can use the operation lens.
Pneumatic test
To perform the pneumatic test (= examination of the eardrum), you require a
ball, which is not included in the normal delivery package, but can be ordered
separately. The tube for the ball is attached to the connector. Now you can
care-fully insert the necessary volume of air into the ear canal.
Technical data of the lamp
Otoscope XL 2.5 V 2.5 V 750 mA ave. life 15 h
Otoscope XL 3.5 V 3.5 V 720 mA ave. life 15 h
Otoscope LED 2.5 V 2.5 V 280 mA ave. life 10.000 h
Otoscope LED 3.5 V 3.5 V 280 mA ave. life 10.000 h
ri-scope®L ophthalmoscopes
Purpose / indication
The Riester ophthalmoscope described in these Operating Instructions is produced for the examination of the eye and the eyeground.
ATTENTION!
Because prolonged intense exposure to light can damage the retina, the use of
the eye exam device should not be unnecessarily prolonged, and the brightness
setting should not be set higher than needed for a clear representation of the
target structures.
The irradiation dose of the photochemical exposure to the retina is the
product of irradiance and duration of irradiation. If the irradiance is
reduced by half, the irradiation time may be twice as long to reach the
maximum limit.
Although no acute optical radiation hazards have been identified for direct or
indirect ophthalmoscopes, it is recommended that the intensity of light
directed into the patient‘s eye be reduced to the minimum required for
examination / diagnosis. Infants / children, aphasics and people with eye
diseases are at a higher risk. The risk may be increased if the patient has
already been examined with this or another ophthalmological instrument during
the last 24 hours. This is especially true when the eye has been exposed to
retinal photography.
The light of this instrument may be harmful. The risk of eye damage increa-ses
with the duration of irradiation. An irradiation period with this instrument
at maximum intensity of longer than >5 min. exceeds the guideline value for
hazards.
This instrument does not pose a photobiological hazard according to DIN EN
62471 but still features a safety shutdown after 2 / 3 minutes.
Lens wheel with correction lens
The correction lens can be adjusted on the lens wheel. The following
correction lenses are available:
L1 and L2 ophthalmoscopes
Plus: 1-10, 12, 15, 20, 40.
Minus: 1-10, 15, 20, 25, 30, 35.
L3 ophthalmoscope
Plus: 1-45 in single steps
Minus: 1-44 in single steps
The values can be read off in the illuminated field of view. Plus values are
dis-played in green numbers, minus values with red numbers.
Apertures
The following apertures can be selected with the aperture hand-wheel:
-
ophthalmoscope
Semi-circle, small/medium/large circular aperture, fixation star, slit. -
ophthalmoscope
Semi-circle, small/medium/large circular aperture, fixation star and slit. -
ophthalmoscope
Semi-circle, small/medium/large circular aperture, fixation star, slit and grid.
Filters
Using the filter wheel, the following filters can be switched for each
aperture: L1 ophthalmoscope Red-free filter
L2 ophthalmoscope Red-free filter, blue filter and polarisation filter.
L3 ophthalmoscope Red-free filter, blue filter and polarisation filter.
Focussing device (only with L3)
Fast fine adjustment of the examination area to be observed is achieved from
various distances by turning the focussing wheel.
Magnifying glass
A magnifying glass with 5-fold magnification is supplied with the ophthalmos-
cope set. This can be positioned between the instrument head and the area
under examination, as required. The area under examination is magnified ac-
cordingly.
Technical data on the lamp
XL 2.5 V ophthalmoscope: 750 mA ave. life 15 h
XL 3.5 V ophthalmoscope: 690 mA ave. life 15 h
LED 3.5 V ophthalmoscope: 280 mA ave. life 10.000 h
Slit and spot retinoscopes
Purpose / indication
The slit/spot retinoscopes (also known as skiascopes) described in these
Operating Instructions are produced to determine the refraction (ametropias)
of the eye.
Initial use and function
Position the required instrument head on point of attachment on top section of
handle with both recesses of the instrument head bottom section being
congruent with the two projecting guide cams of the battery handle. Press
instrument head lightly on battery handle and rotate handle in clockwise
direction to the stop. Remove head by rotating in counter-clockwise direction.
Rotation and focusing of the slit and/or spot image may now be effected by the
knurled screw.
Rotation
The slit or spot image may be rotated by 360° by the control. Each angle may
be directly read from the scale on the retinoscope.
Fixation cards
Fixation cards are suspended and fixed on the object side of the retinoscope
into the bracket for the dynamic skiascope.
Technical data of the lamp
Slit retinoscope HL 2.5 V 2.5 V 440 mA mean life span 15h
Slit retinoscope XL 3.5 V 3.5 V 690 mA mean life span 50h
Spot retinoscope HL 2.5 V 2.5 V 450 mA mean life span 15h
Spot retinoscope XL 3.5 V 3.5 V 640 mA mean life span 40h
Dermatoscope
Purpose / indication
The ri-derma dermascope described in these Operating Instructions is
produced for early identification of changes of skin pigmentation (malignant
me-lanomas).
Commissioning and function
Position the required instrument head on point of attachment on top section of
handle with both recesses of the instrument head bottom section being congru-
ent with the two projecting guide cams of the battery handle. Press instrument
head lightly on battery handle and rotate handle in clockwise direction to the
stop. Remove head by rotating in counter-clockwise direction.
Focusing
Focus the magnifying glass by rotating the eyepiece ring.
Skin-friendly contact plates
2 skin-friendly contact plates are included:
- With a scale of 0-10 mm for the measurement of pigmented lesions such as malignant melanoma.
-
- Without scaling.
Both contact plates are easily removable and replaceable.
- Without scaling.
Technical data of the lamp
ri-derma XL 2.5 V 2.5 V 750 mA ave. life 15 h ri-derma XL 3.5 V 3.5 V 690 mA
ave. life 15 h ri-derma LED 2.5 V 2.5 V 280 mA ave. life 10.000 h ri-derma LED
3.5 V 3.5 V 280 mA ave. life 10.000 h
Bent-arm illuminator
Purpose / indication
The bent-arm illuminator described in these Operating Instructions is
produced for illuminating the oral cavity and the pharynx.
Initial use and function
Position the required instrument head on point of attachment on top section of
handle with both recesses of the instrument head bottom section being congru-
ent with the two projecting guide cams of the battery handle. Press instrument
head lightly on battery handle and rotate handle in clockwise direction to the
stop. Remove head by rotating in counter-clockwise direction.
Technical data of the lamp
bent-arm illuminator XL 2.5 V 2.5 V 750 mA ave. life 15 h
bent-arm illuminator XL 3.5 V 3.5 V 690 mA ave. life 15 h
bent-arm illuminator LED 2.5 V 2.5 V 280 mA ave. life 10.000 h
bent-arm illuminator LED 3.5 V 3.5 V 280 mA ave. life 10.000 h
Nasal speculum
Purpose / indication
The nasal speculum described in these Operating Instructions is produced
for illumination and therefore examination of the inside of the nose.
Initial use and function
Position the required instrument head on point of attachment on top section of
handle with both recesses of the instrument head bottom section being
congruent with the two projecting guide cams of the battery handle. Press
instrument head lightly on battery handle and rotate handle in clockwise
direction to the stop. Remove head by rotating in counter-clockwise direction.
For two modes of operation:
a) Fast expansion
Push set screw on instrument head down with your thumb.
This setting does not allow changes in the position of the speculum legs.
b) Individual expansion
Rotate set screw in clockwise direction until the required expansion width is
obtained. Close legs again by turning screw in clockwise direction.
Swivel lens
The nasal speculum is equipped with a swivel lens of approx. 2.5X enlargement
which may be simply pulled out and/or replaced in the opening provided on the
nasal speculum.
Technical data of the lamp
Nasal speculum XL 2.5 V 2.5 V 750 mA ave. life 15 h
Nasal speculum XL 3.5 V 3.5 V 720 mA ave. life 15 h
Nasal speculum LED 2.5 V 2.5 V 280 mA ave. life 10.000 h
Nasal speculum LED 3.5 V 3.5 V 280 mA ave. life 10.000 h
Tongue depressor
Purpose / indication
The blade holder described in these Operating Instructions is produced for
examination of the oral cavity and pharynx in combination with commercial
wooden and plastic blades.
Initial use and function
Position the required instrument head on point of attachment on top section of
handle with both recesses of the instrument head bottom section being
congruent with the two projecting guide cams of the battery handle. Press
instrument head lightly on battery handle and rotate handle in clockwise
direction to the stop. Remove head by rotating in counter-clockwise direction.
Insert a commercial wooden or plastic tongue blade into the aperture below the
light opening up to the stop. The tongue blade is easy to remove after
examination by actuating the ejector.
Laryngeal mirror
Purpose / indication
The laryngeal mirrors described in these Operating Instructions are
produced for mirroring or examination of the oral cavity and pharynx in
combination with the Riester bent-arm illuminator.
Initial use
Laryngeal mirrors may only be used in combination with the bent arm
illuminator, thus ensuring maximum lighting conditions. Take two laryngeal
mirrors and fix them in the required direction on the bent-arm illuminator.
Operation otoscope for veterinary medicine
Purpose / indication
The Riester operation otoscope described in these Operating Instructions is
produced exclusively for use on animals and for veterinary medicine and there-
fore bears no CE mark. It can be used for illumination and examination of the
auditory canal, as well as for minor operations in the auditory canal.
Attachment and removal of ear specula in veterinary medicine
Position the required speculum on the black bracket of the operating otoscope,
with the recess of the speculum fitting into the guide of the bracket. Attach
speculum by rotating in anti-clockwise direction.
Swivel lens for enlargement
The operating otoscope comprises a small magnifying lens to be swivelled at an
angle of 360° for a maximum enlargement of approx. 2.5 x.
Insertion of external instruments into the ear
The operation otoscope is designed to be open so that external instruments can
be inserted into the animal ear.
Replacing the lamp Otoscope L1
Remove the speculum receptacle from the otoscope. Unscrew the lamp counter clockwise. Tighten the new lamp clockwise and reattach the speculum recep- tacle.
Otoscopes L2, L3, ri-derma, lamp holder, nasal speculum and depres-sor
holder
Remove the instrument head from the battery handle. The lamp is located at the
bottom of the instrument head. Pull the lamp out of the instrument head using
your thumb and forefinger or a suitable tool. Insert the new lamp firmly.
Ophthalmoscopes
Remove the instrument head from the battery handle. The lamp is located at the
bottom of the instrument head. Remove the lamp from the instrument head using
your thumb and forefinger or a suitable tool. Insert the new lamp firmly.
CAUTION:
The pin of the lamp must be inserted into the guide groove on the ophthalmos-
cope‘s instrument head.
Care instructions
General note
The cleaning and disinfecting of the medical devices serve to protect the
patient, the user and third parties and to maintain the value of the medical
devices. Due to the product design and the materials used, there is no defined
upper limit on feasible reprocessing cycles. The service life of medical
devices is determined by their function and careful handling.
Defective products must have completed the entire reprocessing procedure be-
fore being returned for repair.
Cleaning and disinfecting
The instrument heads and handles can be cleaned externally with a damp cloth
until visual cleanliness is achieved.
Wipe with disinfectant according to the instructions of the disinfectant
manufacturer. Only cleaning agents with proven efficacy should be used under
consideration of national requirements.
After disinfecting, wipe the instrument with a damp cloth to remove possible
disinfectant residue.
The contact plates (ri-derma) can be rubbed off with alcohol or a suitable
disinfectant.
Attention!
- Never place the instrument heads and handles in liquids! Make sure that no liquids penetrate the housing interior!
- The article is not approved for machine reprocessing and sterilisation. This can lead to irreparable damage!
Sterilisation
a) Reusable ear specula
The ear specula can be sterilised at 134° C, with a 10 minute period in the
steam steriliser.
b) Single use ear specula
Spare parts and accessories
A detailed list can be found in our brochure, „Instruments for H.N.O.,“ Ophthal-mologic Instruments, which you can find at www.Riester.de https://www .Ries-ter.de/en/productdetails/d/ri-scoper-l-premium-ent-and-ophthalmic-inst- ruments/ri-scoper-l-otoscopes/
Maintenance
The instruments and their accessories require no special maintenance. If an instrument needs to be inspected for any reason, please send it to us or to an authorised Riester dealer in your area, whom we will gladly name upon request.
Instructions
Ambient temperature: 0° to +40°
Relative humidity: 30 % to 70 % non-condensing
Transport and storage temperature: -10 ° to +55 °
Relative humidity: 10 % to 95 % non-condensing
Air pressure: 800 hPa – 1100 hPa
ELECTROMAGNETIC COMPATIBILITY ACCOMPANYING DOCUMENTS ACCORDING TO IEC 60601-1-2, 2014, Ed. 4.0
Attention:
Medical electrical equipment is subject to special precautions regarding
electromagnetic compatibility (EMC).
Portable and mobile radio frequency communication devices can affect medical
electrical equipment. The ME device is for operation in an electromagnetic
environment or home health care and intended for professional facilities such
as industrial areas and hospitals.
The user of the device should ensure that it is operated within such an
environment.
Warning:
The ME device may not be stacked, arranged or used directly next to or with
other devices. When operation is required to be close to or stacked with other
devices, the ME device and the other ME devices must be observed in order to
ensure proper operation within this arrangement. This ME device is intended
for use by medical professionals only. This device may cause radio
interference or interfere with the operation of nearby devices. It may become
necessary to take appropriate corrective measures, such as redirecting or
rearranging the ME device or shield.
The rated ME device does not exhibit any basic performance features in the sense of EN60601-1, which would present an unacceptable risk to patients, operators or third parties should the power supply fail or malfunction.
Warning:
Portable RF communications equipment (radios) including accessories, such as
antenna cables and external antennas, should not be used in closer proximity
than 30 cm (12 inches) to parts and cables of the ri-scope L instrument head
specified by the manufacturer. Failure to comply may result in a reduction in
the device‘s performance features.
Directives and manufacturer‘s declaration – Electromagnetic emissions
The ri-scope L instruments are intended for use in the electromagnetic
environment specified below. The customer or user of the ri-scope® L should
ensure that it is used in such an environment.
Guidance and manufacturer’s declaration - electromagnetic emission
The ri-‐scope L instrument is intended for use in the electromagnetic
environment specified below. The customer or the user of the e-scope® should
ensure that it is used in such an environment
Emission test| Compliance| Electromagnetic environment – guidance
RF emissions
HF- emissions pursuant to CISPR 11
|
Group 1
| The ri-‐scope L uses RF energy
exclusively for an internal function. Therefore his RF transmission is very low and it is unlikely to be adjacent
electronic devices are disturbed.
RF emissions
HF- emissions pursuant to CISPR 11
|
Class B
| The ri-‐scope L is intended for use in all establishments, including
residential areas and those directly connected to a public supply network
that also supplies buildings used for residential purposes.
Emissions of harmonics IEC 61000-3-2| Not applicable
Emissions of voltage fluctuations, flicker
IEC 61000-3-3
|
Not applicable
References
- Rudolf Riester GmbH – Medical devices of the highest standards.
- Otoscopio ri-scope® L2 F.O. Riester
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