Riester M31807EN ri-former Integrated Wall Diagnostic System with 2 Handles Instruction Manual
- June 16, 2024
- Riester
Table of Contents
- Introduction
- Using the Device for the first time
- Operation and Function
- Cleaning and Disinfection
- Technical Data
- ri-scope®L Instrument heads
- Replacing the lamp
- Care instructions
- Spare parts and accessories
- Accessories
- Disposal
- Warranty:
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
Instruction for use
Introduction
1.1. Important Information read prior to Start-up
You have purchased a high quality Riester ri-former® Diagnostic Station, which
has been manufactured according to the Regulation (EU) 2017/745 and is subject
to the strictest quality controls at all times. Read these instructions for
use carefully before putting the unit into operation and keep them in a safe
place. If you should have any questions, we are available to answer queries at
all times. Our address can be found in these instructions for use. The address
of our sales partner will be given upon request. Please note that all
instruments described in these instructions for use are only to be used by
suitably trained personnel. The perfect and safe functioning of this device is
only guaranteed when original parts and accessories from Riester are used.
1.2. Safety Symbols
Symbol | Symbol Note |
---|---|
Follow the instructions in the operation manual. |
The symbol is printed in black color on the probe cover box.
The symbol is printed in blue color on the device.
| Medical Device
| Type B applied part
| Protection class II devices
| Warning!
The general warning sign indicates a potentially hazardous situation which
could result in serious injury.
(Background color yellow, foreground color black)
| Attention!
Important note in this instruction use.
The attention symbol indicates a potentially hazardous situation which may
result in minor or moderate injury. It may also be used to alert against
unsafe practices
| Direct current
| Alternating current
| Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician (licensed healthcare practitioner).
| Manufacturing date
YYYY-MM-DD / (Year-Month-Day)
| Manufacturer
SN| Manufacturer serial number
| Lot number
| Reference number
| 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 devices according to
Directive 2002/96/EC.
| Non-ionizing radiation
| Maximum weight of the basket can bear
| Final maximum weight of whole device including mobile stand, ri-former®
Diagnostic Station, big-ben and basket bear and basket bear the max. weight.
1.3. Packaging Symbols
Symbol | Symbol Note |
---|---|
Fragile. Show transport package contents fragile, so handling 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.
during the operation of wireless telephones or radiological instruments,
adverse effects on function cannot be excluded.
The electromagnetic compatibility of this device has been verified by test
according to the IEC 60601-1-2 requirements
1.4 Intended Use
The ri-former® Diagnostic Station was manufactured for use with various
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 facilities,
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
diagnostic 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 conditions.
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 laughing gas!
The appliance shall not be operated in premises where inflammatory 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 manufacturer for
repair.
| The device is to determine to be used in a controlled environment.
The device must not be exposed to harsh /rough environmental 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 contamination.
-Reusable ear specula Only use cleaned /sterilized ear specula to limit the risk of cross contamination.B110
| To limit the risk of cross-contamination, only use a cleaned,
disinfected nasal specula.
Using the Device for the first time
2.1 Scope of Supply
Art. No.: 3650| ri-former’ 1 handle with clock 3,5 V/100-240 V – User Manual
– Wall mounting material
– Drilling plan
---|---
Art. No.: 3652| ri-formere 1 handle without clock 3,5 V/100-240 V – User
Manual
– Wall mounting material
– Drilling plan
Art. No.: 3650-300| ri-formere 2 handle with clock 3,5 V/100-240 V – User
Manual
– Wall mounting material
– Drilling plans
Art. No.: 3652-300| ri-formere 2 handle without clock 3,5 V/100-240 V – User
Manual
– Wall mounting material
– Drilling plans
2.2 Device Function
The ri-former® Diagnostic Station was made with various instruments for
operating heads and modular components for non-invasive diagnosis.
ri-former® Diagnostic Station| ri-former® Diagnostic Station with Extension
Module
---|---
![Riester M31807EN ri-former Integrated Wall Diagnostic System with 2 Handles
- Figure 1](https://manuals.plus/wp-content/uploads/2024/01/Riester-M31807EN-
ri-former-Integrated-Wall-Diagnostic-System-with-2-Handles-Figure-1.png)
1. ri-former® Diagnostic Station
2. Optional clock
3. ON- OFF Rocker switch with green control lamp
4. Application part / Handle with rheotronic®
5. Switching ring on the handle
6. Handle head
7. Extension Module
1.6 User Responsibility
Attention!
User Responsibility
It is your responsibility to:
Before each use, the user must check the integrity and completeness of the ri-
former® Diagnostic Station / Extension Module /Instruments head. All
components must be compatible with each other.
Incompatible components can result in degraded performance.
Never knowingly use a defective device.
Immediately replace parts that are broken, worn, missing, incomplete, damaged
or contaminated.
Contact the nearest factory approved service center should repair or
replacement become necessary.
Further, the user of the device bears sole responsibility for any malfunction
that results from improper use, faulty maintenance, improper repair, damage or
alteration by anyone other than Riester or authorized service personnel.
****Any serious incident that has occurred in relation to the device should
be reported to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.
Operation and Function
3.1 Attachment
![Riester M31807EN ri-former Integrated Wall Diagnostic System with 2 Handles
- Figure 2](https://manuals.plus/wp-content/uploads/2024/01/Riester-M31807EN-
ri-former-Integrated-Wall-Diagnostic-System-with-2-Handles-Figure-2.png)
3.1.2 Drilling instructions/drilling plan
The drilling instructions and the drilling plan are enclosed separately. Follow the drilling instructions in order to drill the holes in the wall.
3.1.3 Attaching the wall mounting plates
After you have drilled the holes, take the plugs supplied and push them into the holes as far they will go.Take the wall mounting plate and hold it onto the wall so that the screws can be pushed through the holes of the mounting plate into the plugs. Now screw in the screws with a screw driver, as far as they will go.
3.1.4 Attachment of the diagnostic station
When all screws have been screwed in tightly, take the diagnostic station and
guide the screw heads through the openings. Remove the sliding cover of the
diagnostic station. Then press the diagnostic station downwards until it snaps
into
place.
3.1.5 Attachment of the extension module
Connect the diagnostic station and the extension module with the help of the
connecting cable. In order to plug in the connecting cable (a).
Close the casing opening of the extension module, which is not needed, with
the sliding cover (b). Take the extension module and guide the screw heads
through the openings (c). Then press the extension module downwards.
Attention!
Take care that the connecting cable does not get caught behind the extension
module. Push the connecting cable into the groove provided on the reverse side
of the extension module.
3.2 Icon Identification
I | ON |
---|---|
0 | OFF |
HR | Hour setting for the clock |
MIN | Minute setting for the clock |
Dimming the instrument light on the handle | |
Applied part |
Typ B
****| Attention!
Important note in this instruction use
3.3 Commissioning
3.3.1 Put the wall plug-in into the electrical socket. The optional clock
starts to blink.
You can adjust it to local time by repeatedly pressing the keys; with the left
key marked HR and the right key marked MIN.
3.3.2 Move the handle upwards out of the handle holder and attach the desired
instrument head by placing it with the two projecting guide cams onto the
handle. Press the instrument head lightly onto the handle and turn the handle
in a clockwise direction until it stops. Removal of the instrument head is
carried out by turning in a counter-clockwise direction.
3.3.3 Switching on and off.
Switch on the instrument by using the switching ring. Each handle is
automatically ready to operate at 100% light intensity as soon as it is taken
out of the handle holders.
The handle is switched off automatically by putting back into the handle
holder
The handle is automatically switched off when replaced back into the handle
holder.
3.3.4 rheotronic® for light intensity modulation the modulation of light
intensity can be done with the handle; you only have to tip the switching ring
clockwise direction or against clockwise direction and the light gets stronger
or weaker.
Attention!
The handle gets off automatically after abt. 3 minutes.
Make sure that no more than 2 handles are used at the same time! If more than
2 handles are used at the same time, the transformer in the instrument may
become overloaded and switch itself off.
3.4 ri-former® Diagnostic Station Mobile
Please follow the assembly instructions for the mobile stand with riformer®.
The assembly instructions is included in the mobile stand delivery package.
3.5 ri-former® Diagnostic Station Anesthesia
Assembly of the universal clamp.
Please check if the designated wall rail is rigidly mounted on the wall.
Fix the universal clamp on the determinated place of the wall rail and tighten
very well the locking screw. Put the preassembled ri-former® anesthesia device
on the universal clamp and insert it. Please ensure that both pins are
introduced in the universal clamp. Afterwards tighten the ri-former®
anesthesia device with the lateral screw.
Cleaning and Disinfection
4.1 General Information
Cleaning and disinfection of medical products protects patients, users and
third parties, lead to value retention of medical products. Due to product
design and materials used there is no possibility to define the maximum limit
of re- processing cycles. The lifetime of a medical product is determined by
its function and how it is used. Before sending back defective products for
repair, the following instructions should be followed.
4.2 Cleaning and Disinfection
Attention!
– We recommend to remove the wall plug- in of the ri-former® Diagnostic
Station.
– Take care when cleaning and disinfecting the ri-former® Diagnostic Station.
The ri-former® Diagnostic Station can be cleaned on the outside (with the
exception of the display glass cover) using a damp cloth until optical
cleanliness is achieved. Use disinfection products only according to the
manufacturer’s instructions. Only disinfectants with proven effectiveness
according to national guidelines should be used.
After disinfection, please wipe the instruments using a damp cloth in order to
eliminate any remnants of the disinfectant.
- Never place the ri-former® Diagnostic Station and Extension Module or removable parts of the ri-former® Diagnostic Station (handle, cables, Instrument heads) in liquids!
- The ri-former® Diagnostic Station is shipped non-ste- rile. DO NOT use ethylene oxide gas, heat, autoclave or any other harsh methods to sterilize the unit.
- The devices are not meant to undergo machine-processed maintenance and sterilization. This could lead to irreversible damage!
- The single use ear specula is only single use suitable!
For all reusable devices, if there are any signs of material degradation, the device should no longer be reused and should be disposed/claimed following the procedure mentioned under Disposal /Warranty.
Technical Data
Technical Data
Medical device:| Medical device for powering instruments
Electrical protection:| Class II isolation equipment
Model| ri-formers. Diagnostic Station with
ri-former” Extension Module
Power supply| Input: 100 V-240 V AC / 50-60 Hz / 0,6 A
Output: 5VDC/3 A/15 W
ri-formere Diagnostic Station| Input: 5 V DC / 3 A/ 15 W
Output 1: 1 x 3.5 V dc / 700 mA Output 2: 2 x 5 V dc / 2 x 1,15A
ri-formere Extension Module| Input: 5 V DC / 3 A/ 15 W
Output 1: 1 x 3,5 V dc / 700 mA
Output 2: 1 x 5 V dc / 1 x 1,15 A
Classification| Application part type B
Operating conditions| 0° C to + 40° C, 10% up to 85 % relative humidity
Storage and transport conditions| -5° C to + 50° C. 10% up to 85 °A) relative
humidity
Airpressure| 700 bis 1050 hPa
Dimensions| ri-former; Diagnostic station: 200 x 180.5 x 75 mm
Weight| ri-former Diagnostic station: 800 g
Dimensions| ri-former; Extension Module: 200 x 100 x 75 mm
Weight| ri-former” Extension Module: 500 g
Swith-on time| ON: 1 Min / OFF: 5 Min
ri-scope®L Instrument heads
![Riester M31807EN ri-former Integrated Wall Diagnostic System with 2 Handles
- Figure 5](https://manuals.plus/wp-content/uploads/2024/01/Riester-M31807EN- ri-former-Integrated-Wall-Diagnostic-System-with-2-Handles-Figure-5.png)
Putting the instruments heads into operation
Place the desired instrument head onto the attachment on the handle so that
the two recesses on the lower part of the instrument head sit on top of the
two projecting guide cams of the battery handle. Press the instrument head
lightly onto the handle and turn the handle in a clockwise direction until it
stops. To remove the head turn it in a counter-clockwise direction.
Function
Place the desired instrument head onto the attachment on the handle so that
the two recesses on the lower part of the instrument head sit on top of the
two projecting guide cams of the battery handle.
Press the instrument head lightly onto the handle and turn thehandle in a
clockwise direction until it stops. In order to activate the anti-theft
security, turn the Allen screw (b) using the Allen key (a) (included with the
instrument head) until it stops.
The instrument head can now no longer be removed from the handle.
In order to deactivate the anti-theft security, the Allen screw (b) has to be
unscrewed again using the Allen key (a).
6.1 ri-scope®L otoscope
6.1.1 Intended use
The Riester otoscope described in these Operating Instructions is produced for
illumination and examination of the auditory canal in combination with Riester
ear specula.
6.1.2 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 specula.
L1 and L2 otoscopes:
Screw the specula clockwise until noticeable resistance is felt. To remove the
specula, screw the specula counter clockwise.
L3 otoscope:
Fit the chosen specula on the chrome-plated metal fixture of the otoscope
until it locks into place.
To remove the specula, press the blue ejection button. The specula is
automatically ejected.
6.1.3 Swivel lens for magnification
The swivel lens is fixed to the device and can be swivelled 360°.
6.1.4 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.
6.1.5 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 carefully insert the necessary volume of air into the ear canal.
6.1.6 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
6.2 ri-scope®L ophthalmoscopes
6.2.1 Intended use
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 increases
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.
6.2.2 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
displayed in green numbers, minus values with red numbers.
6.2.3 Apertures
The following apertures can be selected with the aperture hand-wheel:
L1 ophthalmoscope:
Semi-circle, small/medium/large circular aperture, fixation star, slit.
L2 ophthalmoscope:
Semi-circle, small/medium/large circular aperture, fixation star and slit.
L3 ophthalmoscope:
Semi-circle, small/medium/large circular aperture, fixation star, slit and
grid.
Icon | Aperture | Function |
---|---|---|
Semicircle: | for examinations with turbid lenses | |
Small circle: | to reduce reflections for small pupils | |
Medium circle: | to reduce reflections for small pupils | |
Large circle: | for normal examination results | |
Grid: | for topographic determination of retina changes | |
Light slit: | to determine differences in level | |
Fixation star: | to ascertain central of eccentric fixation |
6.2.4 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.
Filter | Function |
---|---|
Red-free filter: | contrast enhancing to assess fine vascular changes, e.g. |
retinal bleeding
Polarisation filter:| for precise assessment of tissue colours and to avoid
retinal reflections
Blue filter:| for improved recognition of vascular abnormalities or bleeding,
for fluorescence ophthalmology
For L2 + L3, every filter can be switched to every aperture.
6.2.5 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.
6.2.6 Magnifying glass
A magnifying glass with 5-fold magnification is supplied with the
ophthalmoscope set. This can be positioned between the instrument head and the
area under examination, as required. The area under examination is magnified
accordingly.
6.2.7 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
6.3 Slit and spot retinoscopes
6.3.1 Intended use
The slit/spot retinoscopes (also known as skiascopes) described in these
Operating Instructions are produced to determine the refraction (ametropias)
of the eye.
6.3.2 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
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.
Replacing the lamp
Otoscope L1
Remove the specula receptacle from the otoscope. Unscrew the lamp counter
clockwise. Tighten the new lamp clockwise and reattach the specula receptacle.
7.1 Otoscopes L2, L3, ri-derma, lamp holder, nasal specula and tongue blade
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.
7.2 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.
7.3 Retinoscope slit and spot
Remove the instrument head from the battery handle. The lamp is located in a
sleeve at the base of the instrument head. Remove the lamp from the sleeve
using the thumb and index finger or a suitable tool.
Insert the new lamp firmly into the sleeve and replace the sleeve back into
the instrument head so that the base of the lamp fits into the slot on the
instrument head.
Attention!
The pin of the lamp must be inserted into the guide groove on the
ophthalmoscope‘s instrument head.
Care instructions
8.1 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
before being returned forrepair.
8.2 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 spiral cable/handle/instrument heads 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!
8.3 Sterilisation
Reusable ear specula:
The ear specula can be sterilised at 134° C, with a 10 minute period in the
steam steriliser. Single use ear specula: For single use only!
Warning!
-Disposable ear specula
Only use new ear specula to limit the risk of cross contamination.
-Reusable ear specula
Only use cleaned / sterilized ear specula to limit the risk of cross
contamination
Attention!
More information about
ri-scope®L
ri-scope
are in the Instruction of use Art.No.99220
Spare parts and accessories
A detailed list can be found in „Instruments for H.N.O.,“ Ophthalmologic
Instruments, which you can find at www.riester.de
https://www.riester.de/en/productdetails/d/ri-scoper-l-premium-entand-
ophthalmic-instruments/other-ri-scope-l-accessories/
Electromagnetic Compatibility accompanying Documents according to IEC
60601-1-2
The instrument satisfies the requirements for electromagnetic compatibility.
Please note that under the influence of unfavorable field strengths, e.g.
during the operation of wireless telephones or radiological instruments,
adverse effects on function cannot be excluded.
The electromagnetic compatibility of this device has been verified by test
according to the IEC60601-1-2 requirements.
10.1 EMC (electromagnetic compatibility)
10.1.1 During installation and operation of the device, observe the following
instructions:
10.1.2 Do not use the device simultaneously with other electronic equipment to
avoid electromagnetic interference with the operation of the device.
10.1.3 Do not use or stack the device near, on, or under other electronic
equipment to avoid electromagnetic interference with the operation of the
device.
10.1.4 Do not use the device in the same room as other electronic equipment,
such as life-support equipment that has major effects on the life of the
patient and results of treatment, or any other measurement or treatment
equipment that involves small electric current.
10.1.5 Do not use cables or accessories that are not specified for the device
because that may increase the emission of electromagnetic waves from the
device and decrease the immunity of the device to electromagnetic disturbance.
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 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 en-
vironment.
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 ME device is intended for use
inProfessional Healthcare Facility Environment. 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 IEC 60601-1, which would present an
unacceptable risk to patients, operators or third parties should the power
supply fail or malfunction.
Guidance and manufacture’s declaration – electromagnetic immunity
The ri-former® Diagnostic Station is intended for use in the electro- magnetic
environment specified below. The customer or the user of ri-former® Diagnostic
Station should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance
level| Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4| Con: ± 8 kV Air: ± 15 kV 5/50
ns, 100
kHz; ±2 kV| Con: ± 8 kV Air: ± 15 kV
5/50 ns, 100 kHz; ±2 kV| Floors should be wood, concrete or ceramic tile. If
floor are covered with synthetic material, the relative humidity should be at
least 30%. The quality of the supply voltage should be that of a typical
business or hospital environment.
Surge
IEC 61000-4-5| 1.2/50 (8/20) µs LtL: ± 1.0 kV LtG: ± 2.0 kV| 1.2/50 (8/20) µs
LtL: ± 1.0 kV LtG: ± 2.0 kV| The quality of the supply voltage should be that
of a typical business or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input
lines
IEC 61000-4-11
| 0 % UT for 0.5 cycle (1 phase) 0 % UT for 1 cycle 70 % UT for 25/30
cycles (50/60 Hz)| 0 % UT for 0.5 cycle (1 phase) 0 % UT for 1 cycle 70 % UT
for 25/30 cycles (50/60 Hz)| The quality of the supply voltage should be that
of a typical business or hospital environment.
0 % UT for 50/300 cycles (50/60 Hz)| 0 % UT for 250/300 cycles (50/60 Hz)
Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8| 30 A/m 50 Hz| 30 A/m
50 Hz| Mains frequency ma- gnetic fields should be at a level charac- teristic
of a typical location in a typical commercial hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test
level.
Accessories
Art. No.: 3652-600 | ri-former® with foot and big ben® 3.5 V / 100-240 V |
---|---|
Art. No.: 3652-500 | ri-former® with foot 3,5 V / 100-240 V |
Art. No.: 3652-400 | ri-former® anesthesia model without universal clamp 3.5 V |
/ 100-240 V
Art. No.: 10384| Universal clamp
Extension module, big-ben
Art. No.: 3655-103| big ben® Wickelman. adult
Art. No.: 3655-106| Hakenman. adult
Art. No.: 3655-109| Klettenman. adult
Art. No.: 3655-123| Klettenman. strong arms
Art. No.: 3655-130| Klettenman. children
Extension module, infrared thermometer ri-thermo®N
Art. No.: 3656| Extension module, infrared thermometer ri-ther- mo®N without
anti-theft device
Art. No.: 3656-301| Extension module, infrared thermometer ri-ther- mo®N with
anti-theft device
Art. No.: 3654| ri-spec Ear specula Dispenser Packed in a polybag 25 pcs.
Art. No.: 14065-531| 1 box 40 poly bags 1000 pcs. 2.5 mm hopper Packed in a
polybag 25 pcs.
Art. No.: 14065-534| 1 box 40 poly bags 1000 pcs. 4 mm funnels Packed in a
polybag 25 pcs.
ri-former® Instrument heads without anti-theft device with anti-theft device
ri-scope® L F.O. Otoscope
Art. No.: 10563
Art. No.: 10563-301| L1 3,5 V XL
L1 3,5 V XL with anti-theft device
Art. No.: 10580
Art. No.: 10580-301| L2 3,5 V XL
L2 3,5 V XL with anti-theft device
Art. No.: 10565
Art. No.: 10565-301| L2 3,5 V LED
L2 3,5 V LED with anti-theft device
Art. No.: 10581
Art. No.: 10581-301| L3 3,5 V XL
L3 3,5 V XL with anti-theft device
---|---
Art. No.: 10567
Art. No.: 10567-301| L3 3,5 V LED
L3 3,5 V LED with anti-theft device
ri-scope® Human surgical otoscope without ear specula
Art. No.: 10561
Art. No.: 10561-301| 3,5 V XL
3,5 V XL with anti-theft device
| ri-scope® Veterinary surgical otoscope without ear specula
Art. No.: 10542| 3,5 V XL
Art. No.: 10542-301| 3,5 V XL with anti-theft device
| ri-scope®L Ophthalmoscope
Art. No.: 10569
Art. No.: 10569-301
| L1 3,5 V XL
L1 3,5 V XL with anti-theft device
Art. No.: 10571
Art. No.: 10571-301
| L2 3,5 V XL
L2 3,5 V XL with anti-theft device
Art. No.: 10571-203
Art. No.: 10595-301
| L2 3,5 V LED
L2 3,5 V LED with anti-theft device
Art. No.: 10573
Art. No.: 10573-301
| L3 3,5 V XL
L3 3,5 V XL with anti-theft device
Art. No.: 10573-203
Art. No.: 10596-301
| L3 3,5 V LED
L3 3,5 V LED with anti-theft device
| ri-scope® L Retinoscope (Skiascope)
Art. No.: 10544
Art. No.: 10544-301
| with Spaltlampe 3,5 V XL
with Spaltlampe 3,5 V XL with anti-theft device
Art. No.: 10546
Art. No.: 10546-301
| with Punktlampe 3,5 V XL
with Punktlampe 3,5 V XL with anti-theft device
| ri-derma® Dermatoscope
Art. No.: 10551
Art. No.: 10551-301
| 3,5 V XL
3,5 V XL with anti-theft device
Art. No.: 10577
Art. No.: 10577-301
| 3,5 V LED
3,5 V LED with anti-theft device
| ri-scope® L F.O. tongue depressor holder
Art. No.: 10535
Art. No.: 10535-301
| 3,5 V XL
3,5 V XL with anti-theft device
Art. No.: 10574
Art. No.: 10574-301
| 3,5 V LED
3,5 V LED with anti-theft device
| ri-scope® L F.O. Nasal specula
Art. No.: 10537
Art. No.: 10537-301| 3,5 V XL
3,5 V XL with anti-theft device
Art. No.: 10575
Art. No.: 10575-301| 3,5 V LED
3,5 V LED with anti-theft device
| ri-scope® L F.O. Lamp holder
Art. No.: 10539
Art. No.: 10539-301| 3,5 V XL
3,5 V XL with anti-theft device
Art. No.: 10576
Art. No.: 10576-301| 3,5 V LED
3,5 V LED with anti-theft device
| EliteVue
Art. No.:. 10512| EliteVue head, single, LED, 3.5 V
Art. No.: 10512-301| EliteVue head, single, LED, 3.5 V, with anti-theft device
(for ri-former wall station))
Art. No.: 10513| EliteVue head, single, XL, 3.5 V
Art. No.: 10513-301| EliteVue head, single, XL, 3.5 V, with anti-theft device
(for ri-former wall station)
Disposal
| Attention!
Disposal of the used medical device must be performed in accordance with
current medical practices or local regulations regarding disposal of
infectious, biological medical waste.
---|---
| Batteries and electrical/electronic devices must be disposed in
accordance with locally applicable regulations, not with domestic waste.
****| If you have any questions regarding disposal of products, please
contact the manufacturer or its representatives.
Warranty:
This product has been manufactured under the strictest quality standards and has undergone a thorough final quality check before leaving our factory. We are therefore pleased to be able to provide a warranty of 2 years from the date of purchase on all defects, which can verifiably be shown to be due to material or manufacturing faults. A warranty claim does not apply in the case of improper handling. All defective parts of the product will be replaced or repaired free of charge within the warranty period.This does not apply to wearing parts. For R1 shock-proof, we grant an additional warranty of 5 years for the calibration, which is required by CE-certification. A warranty claim can only be granted if this warranty card has been completed and stamped by the dealer and is enclosed with the product. Please remember that all warranty claims have to be made during the warranty period. We will, of course, be pleased to carry out checks or repairs after expiry of the warranty period at a charge. You are also welcome to request a provisional cost estimate from us free of charge. In case of a warranty claim o repair, please return the Riester product with the completed warranty Card to the following address:
Rudolf Riester GmbH
Dept. Repairs RR
Bruckstr. 31
72417 Jungingen
Deutschland
Serial number or batch number
Date, Stamp and signature of the specialist dealer
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>