Riester Diagnostic Instruments: ri-scope®, ri-scope® L, ri-derma®

1. Important Information to Observe Prior to Initial Use

These Riester diagnostic instruments are manufactured in compliance with Directive 93/42/EEC for medical devices and undergo stringent quality control. For reliable diagnoses, please read these Operating Instructions carefully before initial use and retain them for future reference. Riester products are intended for use by properly trained persons. The faultless and safe function of Riester instruments and accessories is only ensured when using genuine Riester parts.

Safety Precautions:

• Caution: Observe the Operating Instructions! ?
• Device double-earthed.
• Classification: Type-B applied part - otoscope head with speculum.

2. Battery Handles and Initial Use

2.1. Purpose

Riester battery handles supply power to the instrument heads and serve as holders for them. The lamps are contained within the respective instrument heads.

2.2. Battery Handle Range

All Riester instrument heads are compatible with the battery handles described herein and the handles of the ri-former® wall model. Note: LED instrument heads are only compatible with the ri-former® diagnostic station above a certain serial number.

Types of Battery Handles:

• Type C battery handle with 2.5 V rheotronic®: Requires 2 commercial Type C Baby alkaline batteries (IEC LR14) or a 2.5 V ri-accu®. ri-accu® can only be charged in the Riester ri-charger®.
• Type C battery handle with 3.5 V rheotronic®: Requires two CR 123A lithium batteries (with reducing sleeve and LDO controller) or a ri-accu®L 3.5 V. ri-accu®L can only be charged in the Riester ri-charger®L.
• Type C chargeable battery handle (with or without sensomatic®): 2.5 V or 3.5 V function with rheotronic® for mains charging (230 V or 120 V). Compatible only with Riester ri-accu® or ri-accu®L.
• Type AA battery handle with 2.5 V rheotronic®: Requires two commercial Type AA alkaline batteries (IEC LR6) or a ri-accu® 2.5 V. ri-accu® can only be charged in the Riester ri-charger®.
• Type AA battery handle with 3.5 V rheotronic®: Requires two CR 123A lithium batteries (with LDO controller) or a ri-accu®L 3.5 V. ri-accu®L can only be charged in the Riester ri-charger®L.

2.3. Inserting and Removing Batteries and Rechargeable Batteries

Unscrew the handle cover. Insert batteries or rechargeable batteries with the positive end towards the top of the handle (an arrow indicates the direction for rechargeable batteries). Screw the handle cover back on. For lithium batteries (Type C), a reducing sleeve and LDO controller are required.

CAUTION: For lithium batteries (Type C), a reducing sleeve (item no.: 12652) + LDO controller (item no.: 12653) are required.

Handle C (Lithium Batteries): Twist off the cap. Insert reducing sleeve, LDO controller, and lithium batteries (positive poles forward). Screw cap back on.

Handle AA (Lithium Batteries): Twist off the cap. Insert LDO controller and lithium batteries (positive poles forward). Screw cap back on.

To remove batteries, unscrew the cover and shake the handle gently.

Initial Charging: Rechargeable batteries must be charged in the Riester ri-charger® before initial use. Follow the separate operating instructions for the charger.

Plug-in Handle (Type C): Charge for up to 24 hours before initial use.

CAUTION: Do not charge NiMH rechargeable batteries for longer than 24 hours.

Inserting/Replacing Rechargeable Batteries (Type C): Unscrew the handle cover. Insert rechargeable batteries (2.5 V: plus end up; 3.5 V: direction irrelevant). Screw cover back on. For charging, unscrew the lower part of the handle counter-clockwise to reveal mains pins (round for 230 V, flat for 120 V) and plug into the mains socket. CAUTION: Never charge with batteries being replaced!

CAUTION:

• Remove batteries if the device will not be used for a long time or during travel.
• Replace batteries when light intensity weakens.
• Use high-quality batteries for optimal light output.
• Do not charge if liquid or moisture has entered the handle to prevent electric shock.
• Charge ri-accu® batteries only when light intensity has weakened to extend service life.

Waste Disposal: Dispose of batteries and rechargeable batteries as special waste according to local regulations.

2.4. Fitting Instrument Heads

Align the recesses on the instrument head with the guide studs on the battery handle. Press the head onto the handle and screw clockwise until secure. Unscrew counter-clockwise to remove.

2.5. Switching Type C and AA Battery Handles On and Off

Turn the switching ring on the top of the handle clockwise to activate. Turn counter-clockwise to deactivate.

2.6. rheotronic® for Adjusting Light Intensity

Modulate light intensity by turning the switching ring. Clockwise increases intensity, counter-clockwise decreases it. The light intensity resets to 100% upon each switch-on. Automatic safety switch-off occurs after 180 seconds.

3. ri-scope®L Otoscope

3.1. Purpose

Used for illumination and examination of the auditory canal with Riester ear specula.

3.2. Fitting and Removing Ear Specula

Use Riester disposable (blue) or reusable (black) ear specula. The size is marked on the speculum.

• L1 and L2 Otoscopes: Screw speculum clockwise until resistance is felt. Unscrew counter-clockwise to remove.
• L3 Otoscope: Fit speculum onto the chrome-plated fixture until it locks. Press the blue ejection button to release the speculum.

3.3. Swivel Lens for Magnification

The swivel lens is fixed and can be rotated 360°.

3.4. Insertion of External Instruments into the Ear

Rotate the swivel lens 180° to allow insertion of external instruments (e.g., tweezers) using the operation lens.

3.5. Pneumatic Test

Requires a ball (ordered separately) attached to the connector to perform an eardrum examination by introducing air.

3.6. Technical Data of the Lamp

4. ri-scope®L Ophthalmoscope

4.1. Purpose

Used for examination of the eye and the eyeground.

4.2. Lens Wheel with Correction Lenses

Correction lenses are adjusted via the lens wheel. Available lenses include:

• L1 and L2 Ophthalmoscopes: Plus: 1-10, 12, 15, 20, 40. Minus: 1-10, 15, 20, 25, 30, 35.
• L3 Ophthalmoscope: Plus: 1-45 (single steps). Minus: 1-44 (single steps).

Values are displayed in illuminated field: Plus values in green, minus values in red.

4.3. Apertures

Selectable apertures via 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, slit.
• L3 Ophthalmoscope: Semi-circle, small/medium/large circular aperture, fixation star, slit, and grid.

4.4. Filters

Switchable filters for each aperture:

• L1 Ophthalmoscope: Red-free filter.
• L2 & L3 Ophthalmoscopes: Red-free filter, blue filter, and polarisation filter.

For L2 + L3, any filter can be switched to any aperture.

4.5. Focussing Device (only with L3)

Fast fine adjustment of the examination area is achieved by turning the focussing wheel.

4.6. Magnifying Glass

A 5-fold magnifying glass is supplied and can be positioned between the instrument head and the examination area.

4.7. Technical Data of the Lamp

5. Slit and Spot Retinoscopes

5.1. Purpose

Used to determine the refraction (ametropias) of the eye.

5.2. Initial Use and Function

Attach the instrument head to the handle, aligning recesses with guide cams. Press lightly and rotate the handle clockwise to secure. Rotate counter-clockwise to remove. Rotation and focusing of the slit/spot image are done via the knurled screw.

5.3. Rotation

The slit or spot image can be rotated 360° using the control, with angles readable on the scale.

5.4. Fixation Cards

Fixation cards are attached to the object side of the retinoscope into the bracket for dynamic skiascopy.

5.5. Technical Data of the Lamp

6. Dermatoscope

6.1. Purpose

Used for early identification of changes in skin pigmentation (e.g., malignant melanomas).

6.2. Initial Use and Function

Attach the instrument head to the handle, aligning recesses with guide cams. Press lightly and rotate the handle clockwise to secure. Rotate counter-clockwise to remove.

6.3. Focusing

Focus the magnifying glass by rotating the eyepiece ring.

6.4. Skin Adapters

Two skin adapters are supplied:

• 1) With a 0-10 mm scale for measuring melanotic skin changes.
• 2) Without a scale.

Both adapters are suitable for multiple removal and replacement.

6.5. Technical Data of the Lamp

7. Bent-Arm Illuminator

7.1. Purpose

Used for illuminating the oral cavity and the pharynx.

7.2. Initial Use and Function

Attach the instrument head to the handle, aligning recesses with guide cams. Press lightly and rotate the handle clockwise to secure. Rotate counter-clockwise to remove.

7.3. Technical Data of the Lamp

8. Nasal Speculum

8.1. Purpose

Used for illumination and examination of the inside of the nose.

8.2. Initial Use and Function

Attach the instrument head to the handle, aligning recesses with guide cams. Press lightly and rotate the handle clockwise to secure. Rotate counter-clockwise to remove.

• Fast expansion: Push set screw down with thumb. Speculum legs cannot be repositioned.
• Individual expansion: Rotate set screw clockwise to achieve desired expansion. Turn screw clockwise to close legs.

8.3. Swivel Lens

Equipped with a swivel lens (approx. 2.5X magnification) that can be pulled out or replaced.

8.4. Technical Data of the Lamp

9. Blade Holder

9.1. Purpose

Used for examination of the oral cavity and pharynx with commercial wooden and plastic blades.

9.2. Initial Use and Function

Attach the instrument head to the handle, aligning recesses with guide cams. Press lightly and rotate the handle clockwise to secure. Rotate counter-clockwise to remove. Insert a commercial tongue blade into the aperture below the light opening until it stops. Use the ejector to remove the blade.

9.3. Technical Data of the Lamp

10. Laryngeal Mirrors

10.1. Purpose

Used for mirroring or examination of the oral cavity and pharynx in combination with the Riester bent-arm illuminator.

10.2. Initial Use

Use only in combination with the bent-arm illuminator for maximum lighting. Fix two laryngeal mirrors in the required direction on the bent-arm illuminator.

11. Operation Otoscope for Veterinary Medicine

11.1. Purpose

Exclusively for use on animals and in veterinary medicine. Used for illumination and examination of the auditory canal, and for minor operations within the auditory canal. Does not bear a CE mark.

11.2. Attachment and Removal of Ear Specula in Veterinary Medicine

Position the speculum on the black bracket of the operating otoscope, aligning the recess with the bracket's guide. Attach by rotating counter-clockwise.

11.3. Swivel Lens for Enlargement

Includes a 360° swivel magnifying lens (approx. 2.5X magnification).

11.4. Insertion of External Instruments into the Ear

The operating otoscope is designed to be open for insertion of external instruments into the animal ear.

11.5. Technical Data of the Lamp

12. Operation Otoscope for Human Medicine

12.1. Purpose

Used for illumination and examination of the auditory canal, and for insertion of external instruments into the auditory canal.

12.2. Attachment and Removal of Ear Specula for Human Medicine

Place the speculum onto the black holder of the operation otoscope, aligning the recess with the holder's guide. Fix by turning counter-clockwise.

12.3. Swivel Lens for Magnification

Features a 360° swivel magnification lens (approx. 2.5X magnification).

12.4. Insertion of External Instruments into the Ear

Designed to allow insertion of external instruments into the ear.

12.5. Technical Data of the Lamp

13. Replacing the Lamp

• L1 Otoscope: Remove specula fitting. Unscrew lamp counter-clockwise. Screw in new lamp clockwise. Replace specula fitting.
• L2, L3 Otoscopes, ri-derma®, bent-arm illuminator, nasal speculum, blade holder: Unscrew instrument head from battery holder. Pull lamp out from the base of the instrument head. Insert new lamp.
• Ophthalmoscopes: Remove instrument head from battery holder. Remove lamp from the base of the instrument head. Insert new lamp. CAUTION: Ensure the pin on the lamp is inserted into the guide groove on the instrument head.
• Veterinary/Human Operation Otoscope: Unscrew lamp from fixture and screw in a new lamp.

14. Instructions for Care

General Information

Cleaning and disinfection protect patients, users, and third parties, and preserve the value of the devices. The lifespan is determined by function and gentle handling. Defective products must be reprocessed before return for repair.

Cleaning and Disinfection

Clean instrument heads and handles externally with a moist cloth until visually clean. Use disinfectants with proven efficacy according to manufacturer's instructions and national requirements. Wipe down with a moist cloth after disinfection to remove residues. ri-derma® components in contact with skin can be wiped with alcohol or disinfectant.

PLEASE NOTE!

• Never immerse instrument heads and handles in liquids! Prevent liquids from entering the casing.
• This item is not approved for automated reprocessing and sterilization, as these procedures cause irreparable damage.

Sterilization

• Reusable ear specula: Can be sterilized in a steam sterilizer at 134°C for 10 minutes.
• Single-use ear specula: For single use only. WARNING: Repeated use can cause infections.

15. Spare Parts and Accessories

A detailed list is available in the Instruments for E.N.T. and Ophthalmologic Instruments brochure, downloadable at www.riester.de.

16. Maintenance

These instruments and accessories require no specific maintenance. For examination, return the instrument to the company or an authorized Riester dealer.

17. Notices

• Ambient temperature: 0°C to +40°C
• Relative humidity: 30% to 70% non-condensing
• Transport and storage temperature: -10°C to +55°C
• Relative humidity: 10% to 95% non-condensing

18. Electromagnetic Compatibility

Medical electrical equipment requires special precautionary measures regarding electromagnetic compatibility (EMC). Portable and mobile high-frequency communication equipment can influence this ME device. The user should ensure it is operated in the specified environment. Avoid direct use next to or stacked with other devices. Monitor the ME device for normal operation if used near or stacked with other devices. This ME device is intended for professional medical staff only. It may cause radio interference. Remedial measures like re-alignment or shielding may be necessary.

Guidelines and Manufacturer's Declaration - Electromagnetic Emissions

The ri-scope® L is intended for operation in the specified electromagnetic environment. The customer or user should ensure this.

Guidelines and Manufacturer's Declaration - Electromagnetic Immunity

The ri-scope® L model is intended for operation in the specified electromagnetic environment. The customer or user should ensure this.

Recommended safety distances between portable and mobile HF communication devices and the ri-scope® L

The ri-scope® L is intended for operation in an environment where HF interference is monitored. To prevent interference, maintain minimum distances between HF communication equipment and the ri-scope® L, based on the transmitter's maximum output power.

For transmitters not listed, use the equation: d = √(3) * P (for 80 MHz to 1000 MHz) and d = √(10) * P (for 1400 MHz to 2.5 GHz), where P is the transmitter's nominal power in Watts (W).

Note 1: At 80 MHz and 1400 MHz, use the distance for the higher frequency range.

Note 2: Guidelines may vary. Electromagnetic wave propagation is influenced by reflections and absorption.

^a Field strength of stationary transmitters (e.g., base stations, amateur radio, AM/FM/TV transmitters) cannot be precisely determined theoretically. Site investigation is advisable. If field strength exceeds compliance level, monitor normal operation. If unusual performance occurs, take remedial measures like re-alignment or relocation.

^b In the 150 kHz to 80 MHz range, field strength should be less than 3 V/m.