Riester M31807EN ri-former Integrated Wall Diagnostic System with 2 Handles Instruction Manual

Instruction Manual for Riester models including: M31807EN ri-former Integrated Wall Diagnostic System with 2 Handles, M31807EN ri-former, Integrated Wall Diagnostic System with 2 Handles, Wall Diagnostic System with 2 Handles, System with 2 Handles, 2 Handles

ri-former - Gima

23 dic 2023 — The user must comply exactly with the instructions in the instructions for use ... The optional clock starts to blink. You can adjust it to local time by ...

[PDF] ri-former - Gima ITALY

The Riester operation otoscope described in these Operating Instruc- tions is produced for illumination and examination of the auditory canal and for insertion ...

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M31807EN

ri-former®
Gebrauchsanweisung Instruction for use Instructions d`utilisation Instrucciones de uso Istruzioni per l`uso
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Table of Content
1. Introduction 1.1. Important Information read prior to Start-up 1.2. Safety Symbols 1.3 Packaging Symbols 1.4 Intended Use 1.4.1 Indication 1.4.2 Contraindication 1.4.3 Intended patient population 1.4.4 Intended operators / users 1.4.5 Required skills / training of operators 1.4.6 Environmental conditions 1.5 Warnings / Attention 1.6 User Responsibility 2. Using the Device for the first time 2.1 Scope of Supply 2.2 Device Function 3. Operation and Function 3.1 Attachment 3.2 Icon Identification 3.3 Commissioning 3.4 ri-former® mobile 3.5 ri-former® Anesthesia 4. Cleaning and Disinfection 4.1 General Information 4.2 Cleaning and Disinfection 5. Technical Data 6. ri-scope®L Instrument heads / ri-scope Instrument heads 6.1 ri-scope®L otoscope 6.2 ri-scope®L ophthalmoscopes 6.3 Slit and spot retinoscopes 6.4 Dermatoscope 6.5 Bent-arm illuminator 6.6 Nasal specula 6.7 Tongue depressor 6.8 Laryngeal mirror 6.9 Operation otoscope for veterinary medicine 6.10 Operation otoscope for human medicine 7. Replacing the lamp Otoscope L1 7.1 Otoscopes L2, L3, ri-derma, lamp holder, nasal specula and
depressor holder 7.2 Ophthalmoscopes 8. Care instructions 8.1 General note 8.2 Cleaning and disinfecting 8.3 Sterilisation 9. Spare parts and accessories 10. Electromagnetic Compatibility accompanying Documents
according to IEC 60601-1-2 10.1 EMC (electromagnetic compatibility) 11. Accessories 12. Disposal 13. Warranty
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1. 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.

MD 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

Manufacturer serial number

Lot number

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 devices according to Directive 2002/96/EC.
Non-ionizing radiation

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.

Max. Maximum weight of the basket can bear < 1,5 kg

Mass 13 kg

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)

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 influence! 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.

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-

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.
To limit the risk of cross-contamination, only use a cleaned, disinfected nasal specula.
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The device and Ear specula are non-sterile. Do no use on abraded tissue.
The otoscope with LED lighting is not suitable for eye examination. There is a risk of eye damage!
Attention!: The caution symbol indicates a potentially hazardous situation which may result in minor or moderate injury. It may also be used to alert against unsafe practices. The perfect and safe functioning of this instrument is only guaranteed when original parts and accessories from Riester are used.
Cleaning frequency and practices must be consistent with institutional policy for cleaning of non-sterile devices.

2. Using the Device for the first time 2.1 Scope of Supply

Art. No.: 3650 Art. No.: 3652 Art. No.: 3650-300 Art. No.: 3652-300

ri-former® 1 handle with clock 3,5 V/100-240 V - User Manual - Wall mounting material - Drilling plan
ri-former® 1 handle without clock 3,5 V/100-240 V - User Manual - Wall mounting material - Drilling plan
ri-former® 2 handle with clock 3,5 V/100-240 V - User Manual - Wall mounting material - Drilling plans
ri-former® 2 handle without clock 3,5 V/100-240 V - User Manual - Wall mounting material - Drilling plans

- We recommend disconnecting the power adapter of the ri-former® Diagnostic Station from the power supply before cleaning or disinfection.
- Be careful when cleaning and disinfecting the ri-former® diagnosis Station so that no liquid penetrates into the interior.
- Never put detachable parts of the ri-former® diagnosis station and extension modules (spiral cable / handle / instrument heads) in liquids!
- The ri-former® diagnostic Station / instrument heads are supplied non-sterile. DO NOT use ethylene, oxide gas, heat, autoclave, or other harsh methods to sterilize the device.
- The devices / instruments have not been released for machine reprocessing and sterilization. This leads to irreparable damage!
- The disposable ear specula is only suitable for single use!

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

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.

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.
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3. Operation and Function 3.1 Attachment
3.1.1 Drilling plan
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.

3.2 Icon Identification

OFF

Hour setting for the clock

MIN Minute setting for the clock

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.

Dimming the instrument light on the handle

Applied part Typ B

Attention! Important note in this instruction use a)

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.

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.

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.

3.4 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.
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4. 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 pro-

duct is determined by its function and how it is used. Before sending

back defective products for repair, the following instructions should be

followed.

ri-scope®L Instrument heads ri-scope Instrument heads

4.2 Cleaning and Disinfection
Attention! - We recommend to remove the wall plug- in of the ri-for-
mer® 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-sterile. 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.

ri-scope®L otoscope

ri-scope®L ophthalmoscopes

Dermatoscope

Bent-arm illuminator

Tongue blade holder Laryngeal mirror
Operation otoscope for veterinary medicine

Slit and spot retinoscopes
Nasal speculum
Operation otoscope for human medicine

5. Technical Data Technical Data Medical device: Electrical protection:
Model
Power supply
ri-former® Diagnostic Station
ri-former® Extension Module
Classification Operating conditions Storage and transport conditions Airpressure Dimensions Weight Dimensions Weight Swith-on time 5

Medical device for powering instruments
Class II isolation equipment
ri-former® Diagnostic Station with ri-former® Extension Module
Input: 100 V-240 V AC / 50-60 Hz / 0,6 A Output: 5 V DC / 3 A / 15 W
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 1,15 A
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
Application part type B
0° C to + 40° C, 10% up to 85 % relative humidity
-5° C to + 50° C, 10% up to 85 % relative humidity
700 bis 1050 hPa
ri-former® Diagnostic station: 200 x 180.5 x 75 mm
ri-former® Diagnostic station: 800 g
ri-former® Extension Module: 200 x 100 x 75 mm
ri-former® Extension Module: 500 g
ON: 1 Min / OFF: 5 Min

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 the handle 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

6.2.3 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.

Aperture

Function

Semicircle: Small circle: Medium circle: Large circle:

for examinations with turbid lenses to reduce reflections for small pupils to reduce reflections for small pupils for normal examination results

Grid: Light slit:

for topographic determination of retina changes
to determine differences in level

Fixation star:

to ascertain central of eccentric fixation

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.

6.2.4 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

6.2.2 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.

6.3 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.

6.3.3 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.
6.3.4 Fixation cards Fixation cards are suspended and fixed on the object side of the retinoscope into the bracket for the dynamic skiascope.
6.3.5 Slit/Spot design The slit retinoscope may be converted to a spot retinoscope by exchanging the slit lamp against a spot lamp.
6.3.6 Technical data of the lamp Slit retinoscope HL 2.5 V 2.5 V 440 mA mean life span 15 h Slit retinoscope XL 3.5 V 3.5 V 690 mA mean life span 50 h Spot retinoscope HL 2.5 V 2.5 V 450 mA mean life span 15 h Spot retinoscope XL 3.5 V 3.5 V 640 mA mean life span 40 h
6.4 ri- derma Dermatoscope 6.4.1 Intended use
The ri-derma dermascope described in these Operating Instructions is produced for early identification of changes of skin pigmentation (malignant melanomas).
6.4.2 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.
6.4.3 Focusing Focus the magnifying glass by rotating the eyepiece ring.
6.4.4 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.
6.4.5 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 h24
6.5 Bent-arm illuminator 6.5.1 Intended use
The bent-arm illuminator described in these Operating Instructions is produced for illuminating the oral cavity and the pharynx.
6.5.2 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.
6.5.3 Technische Daten der Lampe 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
6.6 Nasal speculum 6.6.1 Intended use
The nasal speculum described in these Operating Instructions is produced for illumination and therefore examination of the inside of the nose.

For two modes of operation: Fast expansion: Push set screw on instrument head down with your thumb. This setting does not allow changes in the position of the specula legs. Individual expansion: Rotate set screw in clockwise direction until the required expansion width is obtained. Close legs again by turning screw in clockwise direction.
6.6.3 Swivel lens The nasal specula 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 specula.
6.6.4 Technical data of the lamp Nasal specula XL 2.5 V 2.5 V 750 mA ave. life 15 h Nasal specula XL 3.5 V 3.5 V 720 mA ave. life 15 h Nasal specula LED 2.5 V 2.5 V 280 mA ave. life 10.000 h Nasal specula LED 3.5 V 3.5 V 280 mA ave. life 10.000 h
6.7 Tongue blade holder 6.7.1 Intended use
The Tongue 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.
6.7.2 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. 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.
6.7.3 Technical data of the lamp Depressor holder XL 2.5 V 2.5 V 750 mA ave. life 15 h Depressor holder XL 3.5 V 3.5 V 720 mA ave. life 15 h Depressor holder LED 2.5 V 2.5 V 280 mA ave. life 10.000 h Depressor holder LED 3.5 V 3.5 V 280 mA ave. life 10.000 h
6.8 Laryngeal mirror 6.8.1 Intended use
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.
6.8.2 Commissioning and function 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.
6.9 Operation otoscope for veterinary medicine without speculum 6.9.1 Intended use
The Riester operation otoscope described in these Operating Instructions is produced exclusively for use on animals and for veterinary medicine and therefore 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.
6.9.2 Attachment and removal of ear specula in veterinary medicine Position the required specula on the black bracket of the operating otoscope, with the recess of the specula fitting into the guide of the bracket. Attach specula by rotating in anti-clockwise direction.
6.9.3 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.

6.6.2 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.

6.9.4 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.
6.9.5 Technical data of the lamp Operating otoscope HL 2.5 V 2.5 V 680 mA ave. life 20 h Operating otoscope XL 3.5 V 3.5 V 700 mA ave. life 20 h

6.10 Operation otoscope for human medicine 6.10.1Intended use
The Riester operation otoscope described in these Operating Instructions is produced for illumination and examination of the auditory canal and for insertion of external instruments into the auditory canal.
6.10.2 Placing and removing ear specula for human medicine Place the desired specula on the black holder on the surgical scope so that the notch on the specula fits into the guide in the holder. Fasten the specula by turning it clockwise.
6.10.3 Swivel magnifying lens for enlarging There is a small 360 ° swivel magnifying lens on the surgical oscilloscope with a magnification power of about 2.5 times.

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!

6.10.4 Insertion of external instruments into the ear The operating otoscope is designed so that external instruments can be inserted into the ear.
6.10.5 Technical data of the lamp Operating otoscope HL 2.5 V 2.5 V 680 mA ave. life 40 h Operating otoscope XL 3.5 V 3.5 V 700 mA ave. life 40 h

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

7. 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 lo-

cated 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.

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/

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.

10. 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:

Attention! The pin of the lamp must be inserted into the guide groove on the ophthalmoscope`s instrument head.
8. 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 for repair.
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

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.
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 Diagnostic station ri-former 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 Diagnostic station ri-former are intended for use in the electromagnetic environment specified below. The customer or user of the Diagnostic station ri-former should ensure that it is used in such an environment.

Guidance and manufacture's declaration electromagnetic immunity
The ri-former® Diagnostic Station is intended for use in the electromagnetic 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 Compliance test level 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 5/50 ns, 100 kHz; kHz; ±2 kV ±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

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)

The quality of the supply voltage should be that of a typical business or hospital environment.

0 % UT for 250/300 cycles (50/60 Hz)

Power frequency (50Hz/60Hz) magnetic
field IEC 61000-4-8

30 A/m 50 Hz

Mains frequency ma-
gnetic fields should be at a level characteristic 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.

Guidance and manufacture's declaration electromagnetic emission

The ri-former® Diagnostic Station intended for use in the electromagnetic environment specified below. The customer of the user of the Diagnostic station ri-former should assure that it is used in such an environment.

Emission test

Compliance

Electromagnetic environment guidance

RF-Emissionen CISPR 11

Group 1

The ri-former® Diagnostic Station uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF-Emission CISPR 11

Class B

Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3

Pass Pass

The ri-former® Diagnostic Station 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.

Guidance and manufacture's declaration electromagnetic immunity
The ri-former® Diagnostic Station is intended for use in the electromagnetic environment specified below. The customer or the user of the Diagnostic station ri-former should assure that it is used in such an environment.

Immunity test

IEC 60601 Compliance Electromagnetic

test level level

environment - guidance

Conducted RF IEC 61000-4-6

Pass

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,7 GHz

3 V/m

Proximity fields from RF wireless communi-cations equipment

Pass

Portable and mobile RF communications equipment should not be used closer to any part of the ri-former® Diagnostic Station, including the cables, than the recommended distance, which is calculated using the equation applicable to the transmitter frequency. Recommended separation distance d= 1.2P 150 KHz to 80 MHz d= 1.2P 80 MHz to 800 MHz d= 2.3P 800 MHz to 2,7 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Where P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer and the recommended distance is given in meters (m). Field strengths from fixed RF transmitters determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of devices marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a.) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and landmobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreticallywith accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic sitesurvey should be considered. If the measured field strength in the location in which the Diagnostic station ri-former is used exceeds the applicable RF compliance level above, the Diagnostic station ri-former should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ri-former® Diagnostic Station. b.) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the ri-former® Diagnostic Station.
The ri-former® Diagnostic Station is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ri-former® Diagnostic Station can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ri-former® Diagnostic Station as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter
(W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 80 MHz to 800

MHz

800 MHz to 2,7 GHz

d =12P

d =1,2P

d =2,3P

0,01

0,12

0,23

0,1

0,38

0,73

1,2

2,3

3,8

7,3

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d inmetres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is themaximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption andreflection from structures, objects and people.

11. Accessories Art. No.: 3652-600 Art. No.: 3652-500 Art. No.: 3652-400 Art. No.: 10384
Art. No.: 3655-103 Art. No.: 3655-106 Art. No.: 3655-109 Art. No.: 3655-123 Art. No.: 3655-130
Art. No.: 3656 Art. No.: 3656-301 Art. No.: 3654 Art. No.: 14065-531 Art. No.: 14065-534
Art. No.: 10563 Art. No.: 10563-301 Art. No.: 10580 Art. No.: 10580-301 Art. No.: 10565 Art. No.: 10565-301

ri-former® with foot and big ben® 3.5 V / 100-240 V
ri-former® with foot 3,5 V / 100-240 V
ri-former® anesthesia model without universal clamp 3.5 V / 100-240 V
Universal clamp
Extension module, big-ben
big ben® Wickelman. adult
Hakenman. adult
Klettenman. adult
Klettenman. strong arms
Klettenman. children
Extension module, infrared thermometer ri-thermo®N
Extension module, infrared thermometer ri-thermo®N without anti-theft device
Extension module, infrared thermometer ri-thermo®N with anti-theft device
ri-spec Ear specula Dispenser Packed in a polybag 25 pcs.
1 box 40 poly bags 1000 pcs. 2.5 mm hopper Packed in a polybag 25 pcs.
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
L1 3,5 V XL L1 3,5 V XL with anti-theft device
L2 3,5 V XL L2 3,5 V XL with anti-theft device
L2 3,5 V LED L2 3,5 V LED with anti-theft device
10

Art. No.: 10581 Art. No.: 10581-301 Art. No.: 10567 Art. No.: 10567-301
Art. No.: 10561 Art. No.: 10561-301
Art. No.: 10542 Art. No.: 10542-301
Art. No.: 10569 Art. No.: 10569-301 Art. No.: 10571 Art. No.: 10571-301 Art. No.: 10571-203 Art. No.: 10595-301 Art. No.: 10573 Art. No.: 10573-301 Art. No.: 10573-203 Art. No.: 10596-301
Art. No.: 10544 Art. No.: 10544-301 Art. No.: 10546 Art. No.: 10546-301
Art. No.: 10551 Art. No.: 10551-301 Art. No.: 10577 Art. No.: 10577-301
Art. No.: 10535 Art. No.: 10535-301 Art. No.: 10574 Art. No.: 10574-301
Art. No.: 10537 Art. No.: 10537-301 Art. No.: 10575 Art. No.: 10575-301
Art. No.: 10539 Art. No.: 10539-301 Art. No.: 10576 Art. No.: 10576-301
Art. No.:. 10512 Art. No.: 10512-301
Art. No.: 10513 Art. No.: 10513-301

L3 3,5 V XL L3 3,5 V XL with anti-theft device
L3 3,5 V LED L3 3,5 V LED with anti-theft device
ri-scope® Human surgical otoscope without ear specula
3,5 V XL 3,5 V XL with anti-theft device
ri-scope® Veterinary surgical otoscope without ear specula
3,5 V XL
3,5 V XL with anti-theft device
ri-scope®L Ophthalmoscope
L1 3,5 V XL L1 3,5 V XL with anti-theft device
L2 3,5 V XL L2 3,5 V XL with anti-theft device
L2 3,5 V LED L2 3,5 V LED with anti-theft device
L3 3,5 V XL L3 3,5 V XL with anti-theft device
L3 3,5 V LED L3 3,5 V LED with anti-theft device
ri-scope® L Retinoscope (Skiascope)
with Spaltlampe 3,5 V XL with Spaltlampe 3,5 V XL with anti-theft device
with Punktlampe 3,5 V XL with Punktlampe 3,5 V XL with anti-theft device
ri-derma® Dermatoscope
3,5 V XL 3,5 V XL with anti-theft device
3,5 V LED 3,5 V LED with anti-theft device
ri-scope® L F.O. tongue depressor holder
3,5 V XL 3,5 V XL with anti-theft device
3,5 V LED 3,5 V LED with anti-theft device
ri-scope® L F.O. Nasal specula
3,5 V XL 3,5 V XL with anti-theft device
3,5 V LED 3,5 V LED with anti-theft device
ri-scope® L F.O. Lamp holder
3,5 V XL 3,5 V XL with anti-theft device
3,5 V LED 3,5 V LED with anti-theft device
EliteVue
EliteVue head, single, LED, 3.5 V
EliteVue head, single, LED, 3.5 V, with anti-theft device (for ri-former wall station))
EliteVue head, single, XL, 3.5 V
EliteVue head, single, XL, 3.5 V, with anti-theft device (for ri-former wall station)

12. 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.

13. 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

99249 Rev. 01 2021-11 Änderungen vorbehalten · Subject to alterations · Sous reserve de modifications · Sujeto a modificaciones · Con riserva di apportare modifiche·

References

Riester - Medical devices of the highest standards

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