Riester RCS-100 Medical Camera System with Lenses and Adapters Instruction Manual

RCS-100
Instruction For Use

RCS-100 with optics lenses and accessories

adapter
Otoscope Module (OT)| Module for eardrum imaging| specula
Dermatoscope Module (DE)| Module for skin imaging| —————-
General Module (GE)| Module for mouth and throat imaging| —————-

Important information read prior to start-up

You have purchased a high quality Riester RCS-100, which has been manufactured according to the Directive 93/42 EEC 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 instrument is only guaranteed when original parts and accessories from Riester are used.
2.1 Important Symbols

part
| The operator is advised to read the instructions of user manual
| Manufacturer serial number
| Lot number
| Manufacturing date
| Manufacturer
| CE mark
| The symbol indicating li-battery recyclable
| The symbol indicating separate collection for Waste Electric and Electrical Equipment per Directive 2000/532/EC
| The symbol indicating separate collection for Waste Electric and Electrical Equipment per Directive 2002/96/EC
****| Temperature for transport and storage condition
| Relative Humidity for transport and storage condition
| Non-ionizing radiation
| Attention: Do not look into the beam
| LED light
Do not look in the beam Class 1 LED
| 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
| „Green dot“ (country-specific)

2.2 Camera handling
Protect the camera from excessive vibration, force, or pressure.
Avoid using the camera under the following conditions, which may damage the lens, the handset and may also cause the camera to malfunction or prevent recording:

• Dropping or hitting the camera against a hard surface.
• Exerting excessive force on the lens.

The camera is not dust or splash resistant or waterproof.
Avoid using the camera in places with excessive dust, sand or where water can come into contact with the camera. Particular care should be given to the lens and gaps around buttons.
In extremely dusty or sandy places, or exposing the camera to rain, or moisture, can result in damage which may not be repairable.
2.3 Condensation
(when the lens or the monitor is fogged up)
Condensation may occur when the camera is exposed to sudden changes of temperature or humidity.
Avoid these conditions because they may soil the lens or the monitor, cause mold, or damage the camera. If condensation does occur,turn off the camera and wait for about two hours before usingit. Once the camera adjusts to the surrounding temperature,the fogging will clear naturally.

Warnings and contraindications!

3.1 When in use

• The camera may become warm if used for prolonged pe- riod of time.
• Keep the camera as far away as possible from electroma- gnetic equipment (such as microwave ovens, TVs, videogames, etc.).
• Do not use the camera near radio transmitters or highvoltage lines.
• Never leave the camera and the battery in a car or on a carhood in the summer. Doing so may cause leakage of thebattery electrolyte, overheating, fire, or a battery explosiondue to the high temperature.
• If the optical lens and control unit get wet, do not attempt to dry with a heater, microwave, autoclave, or UV light.
• Do not extend the supplied cables. Do not keep the powercord near any heat source.
• Disposal of used ear specula must be performed in accordance with current medical practices or local regulations regarding disposal of infectious,biological medicalwaste.
• Disposal of spent lithium battery must be performed inaccordance with local regulations regarding disposal of libattery waste.

3.2 Charging

• The time required for charging varies depending on the conditions of battery usage. Charging takes longer at high or low temperatures and when the battery has not been used for some time.
• The battery will get warm during charging and stay warm for some time thereafter.
• The battery will be drained completely if not used for long periods of time, even after being charged.
• Only use Li-ion Battery 3.6 V and 2.600 mAh provided by the manufacturer. The battery has an integrated protection circuit. To ensure the safety of the product operation, if the battery reaches its lifetime, please contact the manufacturer to buy a spare
  battery.

3.3 Protection

• Do not attempt to remove the housing from the product to prevent the product from malfunctioning.
• No modification of this device is allowed. The performance would be subject to any modification and may cause hazardous radiation exposure.

Intended use

The Riester camera system (RCS-100) is a portable and multifunctional electronic imaging diagnostic system which consists of OT, DE, and GE three replaceable modules. This camera system is designed to be operated by anyone who is eighteen years and older or medical professionals to capture images and video in specified operating environment.
Otoscope (OT):
intended to capture images and videos of eardrum of the ear.
Dermatoscope (DE):
intended to capture images and videos of skin.
General Lens (GE):
intended to capture digital images and video of mouth / throat.

Specified operating environment:

• Professional healthcare facility environment:
  Physician offices, Dental offices, Clinics, Limited care facilities, Freestanding surgical centers; Freestanding birthing centers; Multiple treatment facilities; Hospitals (emergency rooms, patient rooms, intensive care, surgery rooms except near HF SURGICAL EQUIPMENT, outside the RF shielded room of an ME SYSTEM for magnetic resonance imaging).

What to do before first use

• Remove the Riester Camera System from the sales packa-ge and check that all parts are undamaged
• Install the battery as instructed in point 7.3 of this manual.

Main unit

1. Touch screen
2. Wheel
3. Handle
4. Power button (on/off)
5. LED-display
6. Lens mount
7. Battery cover
8. Wifi-SD slot
9. Lens connecting pins
10. CMOS
11. Positioning fixed point
12. Type-C USB connector
13. DE module
14. GE module
15. OT module
16. Disposable specula
17. Contact PCB
18. Lens connector
19. Hole for pneumatic test
20. Charging adapt
21. USB connector
22. Type-C USB cable
23. Adapt connector
24. Adapt connector mount

Operating instruction

7.1 Lens exchange:

a) Lens assembly:

1. Hold the handset in the left hand and the lens to be mounted in the right hand
2. Align lens marks with handset marks
3. Hold and rotate the lens clockwise and install it in place

b) Lens removal:

1. Hold the handset in the left hand and the lens in the right hand
2. Rotate the lens counter clockwise and remove the lens

7.2 Specula replacement
a) Install specula:
Fingers pinch the specula to be installed, align OT and gently push it in and lock the specula.

Warning:
Only use the specula provided by the manufacturer.
Warning:
Check the accessories and their packages for any sign of da-mage, do not use them if any damage is detected.

b) Remove specula:

1. Hold the handset in the left hand and the lens in the right hand.
2. Fingers pinch the specula replacement device and pull it outward until the specula fall off.

Warning:
The disposal of specula shall meet requirements of local laws and regulations.
7.3 Battery replacement

1. Hold down and push out the battery cover with your fingers and remove the battery cover.
2. Remove the original battery and the battery cable.
3. Hold the battery cable with your thumb and forefinger and connect it to the connector in the correct direction.
4. Put the battery into the battery compartment and tidy up the cable. See 3.2 for type of battery.
5. Replace the battery cover by pushing it up in lock position.

Warning:
If the device is unlikely to be used for an extended time period, remove the batteries prior to shipping or storage by skilled or trained person.

7.4 Power-on/off

1. Press power button for 3 seconds to power on/off the system.
2. After power on the screen display the startup picture.
3. About 25 seconds, the system completed start-up and automatically recognizes the lens (if a lens is installed) and display the appropriate main page.

7.5 Indicator LED
An indicator on the top left corner of the device shifts in white and green to show device status.

• The handset works in sleep mode: green light flashing
• Low battery: white light flashing
• Battery charging: white light is on
• Full charged: green light is on

7.6 Settings
Tap to enter the setting page.User can set parameter by select item in setting list and touch screen. It is recommended that all setting items are set according to user’s requirements for first-time use .
Tap to enter the setting page.
Patient data:
“Patient data” can be enabled/disabled.
If disable, the patient information icon will not be shown on the screen and the photos/videos record name is excluding the patient last name, file name setting will also be invisible and deactivated.
If enable, file name setting will be visible to choose.

• File name format:
  User can choose shooting time or last name appears first in the record name. Patient info| File Name Rule| Module| File Name
  ---|---|---|---
  enable| Last Name

• Shooting Time| OT| Last name + shooting time + O + L/R
  DE| Last name + shooting time + D
  GE| Last name + shooting time + G
  Shooting Time

• Last Name| OT| shooting time + Last name + O + L/R
  DE| shooting time + Last name + D
  GE| shooting time + Last name + G
  disable| | OT| shooting time + O + L/R
  DE| shooting time + D
  GE| shooting time + G

• Font size:
  User can set the system font size to small, normal, large or extra large.

• Date & time:
  User can set the current date & time.

• Language:
  User can set system language as “English, Chinese, German, Spanish, Russian, French, Italian, Arabic”. Italian, Arabic”

• LCD backlight:
  User can set LCD screen backlight brightness.

• Sleep made
  The user can set the time for sleep mode.
  The sleep mode serves to optimize battery life and is auto-matically activated if the RCS-100 is not in operation.
  The options are 2, 5, 10, 30 minutes or never.

• White balance
  The white balance is to adjust the camera to the color tem- perature of the light for the specific requirements when working with the RCS-100.

The following options are available

1. Auto white balance
2. Incandescent (light bulb 2800 Kelvin)
3. Daytight (daylight 5600 Kelvin)
4. Fluorescent (neon light 4500 Kelvin)
5. Cloudy (cloudy 7500 Kelvin)
6. Twilight (twilight 10000 Kelvin)
7. Shade (shade 9000 Kelvin!
8. Warm fluorescent (neon light 6500 Kelvin)

• Right handed mode:User can set left / right handed operation mode according to their operating habits.

• Preserve lens setting:
  The system can be set to ‚default‘ mode or ‚record keeping‘mode. When the lens is changed in ‚default‘ mode, the system will reset to default parameters. When the lens is changed in ‚record keeping‘ mode, the parameters of the lastused lens would be preserved.

• Duration of image review:
  The user can set the review time for which the photo is displayed after taking the shot. The review time can be set to 2, 3, 5 seconds and freeze. If set to freeze, the image will be displayed until the next command is given (use of control wheel or touch to the display).

• Dermatoscope ruler unit:
  There is a software ruler in the main interface of dermatoscope, user can set the software ruler unit to mm or inch.

• Dermatoscope focus correction:
  In dermatoscope mode, user can correct the focusing length.

• Place the DE lens on the desired surface, at the desired focus distance. The system will automatically focus. If the focus is poor, pick up the camera and repeat. When the image can be seen clearly tap ‚SET FOCUS‘ to save the focus data and then return to the main menu.

• Hospital name:
  When hospital name is entered, it will be displayed at the bottom right of test report.

• About:
  About item shows model version, software version, hardware version, storage and factory data reset.

• Factory data reset:

Warning:
Performing the factory data reset will lose recorded files. 7.7 Records manager
Tap ****to enter the records management page. All records displayed in records list by time reverse.

a) Review a record:
Click on the record wanted to review and enter record view page.

1. Finger slides on the touch screen left/right to review previous/next record.

2. Use two fingers to move closer (zoom in) or farther away (zoom out) to view the image on the touch screen.
   When the image is zoomed in, use a finger to move the image around the screen so the entire image can be seen.

3. Tap to delete the picture.

4. Tap to enter a page that all photos are displayed in square form.

5. Tap to come back to main page.

1. Tap a record to select/deselect it.
2. Tap to select/deselect all records.
3. Tap to delete the selected records.
4. Tap to come back to main page.

7.8 Patient information
a) Patient information data:

“Patient Info” in parameter setting page, patient information enable and patient information disable.
b) Patient information add/edit (patient Info ):
If patient did not add (shown by ):

1. Tap to enter the patient information add page.
2. Enter the correct last name, first name, birthday, gender.
3. Tap  to finish the patient information addition.

If patient has already added (shown by ):

1. Tap to enter the patient information edit page.
2. Enter the correct last name, first name, birthday, gender.
3. Tap to complete the patient information editing.

7.9 Connect PC
a) USB disk mode:
Image data transfer method to a PC is similar as with a USB Stick. When connected to a PC running Microsoft Windows, the operating system displays optional mode of operation.

RCS-100
Wahlen Sie eine Aktion fur dieses Gerat aus.

| Fotos und Videos importieren
Fotos
---|---
| Digitale Mediendateien mit Gerat synchron…
Windows Media Player
| Gerat zum Anzeigen der Dateien dffnen
Explorer
| Keine Aktion durchfihren

It is possible to select an appropriate image viewing program,or simply open the folder to view and transfer files to the PC.
b) UVC mode:
The camera can work on UVC mode.

1. Please activate the UVC-mode in the settings.
2. Open windows system UVC component on computer.
3. Camera connects to the computer by USB cable.
4. Power on the camera.
5. Windows UVC component automatically connect the camera and display the preview image of the Camera.

Warning:
PC should follow EN 60950-1 standard.
7.10 Wifi-SD
This device only supports TOSHIBA FlashAir Wifi-SD card (optional) to expand internal storage or support Wlan. You can also use the TOSHIBA FlashAir center setup guide. More information about the card can be found in TOSHIBA internet pages: http://www.toshiba-personalstorage.cn
Warning:
Does not guarantee use of other brands of Wifi-SD/SD cards.
a) Wifi-SD card installation:
Put Wifi-SD card into handset card slot (as shown below) and push it into place. b) Use Wifi- SD on handset:
When Wifi-SD is installed, system first saves records on Wifi-SD until it is full, and then system saves records on internal storage.
c) PC connect Wifi-SD:
In the PC (with Wifi function) Wifi management page, select the name of „flashair_XXXXXXXXXXX“connection, and enter the password (initial password 12345678).
After the connection is successful, the PC automatically displays file management page, and you can view captured records that had been saved on Wifi-SD/SD on the file management page.

Imaging using optics module otoscope (OT)

The RCS-100 camera with otoscope lens is intended to capture digital images and videos of the eardrum.

It consists of:

• Camera handset.
• Attachable otoscope module.
• Disposable specula (default Ø 4).

The otoscope supports adjust brightness, manual/auto focus, left/right ear mode.
The picture brightness can be automatically adjusted by the system according to the illumination intensity of the subject in real time, and it can be adjusted manually.
The brightness level can be adjusted manually in 6 steps.
Illumination will turn off when the brightness level is at the lowest level, and it will turn on when the brightness level is more than the lowest level.

8.1 Steps for eardrum imaging:

1. Connect the inflation system (when a pneumatic test is required).

2. Install disposable specula.

3. Tap to select the left or right ear to be examined.

4. Tap L/M/H to select the specula, low (L), medium (M), high (H)

5. The examiner pulls the auricle using one hand to straighten the ear canal as much as possible, and usingthe other hand gently put the lens into the external auditory canal until the front end of OT reaches thecartilage site.

6. Tap to enter adjust brightness function and turn wheel or slide the process bar to adjust brightness of the picture.

7. Tap to select manual/auto focus.
   When is selected, click on the position in the preview area where you want to focus, the system will automatically focus according to the selected position.
   When is selected , turn the wheel or drag the focus progress bar on the touch screen to complete manual focus.

8. Tap to select a capture mode.
   To take photos
   a) When photo mode is selected:
   Tap to enter picture taking photo mode .
   • Tap again or turn the wheel to capture photo.
   • When the photo has captured, will change to , and the image will be saved in Wifi-SD (if used) or to the internal storage, if “Save” is selected in the pop-up window. If “Don‘t save” is selected, the image will be discarded.
   To record video
   b) When video mode is selected:
   • Tap to enter video capture mode .
   • Tap or turn the wheel to start the video and will change to .
   • Tap or turn the wheel to stop the video with showing the saving reminder information. And the video will be saved in Wifi-SD (if used) or in internal memory.

9. **** Tap to review the results of the photo or start the next photo.

Imaging using optics module dermatoscope (DE)

The RCS-100 camera with dermatoscope lens is intended to capture digital images and videos of the skin. The focus position of the DE is preset at the factory, and in the “Dermatoscope Focus Correction” in the Setting page, user can reset the focus position (see the detail at section 8.6). The dermatoscope has a ruler that can measure the length of the part to be photographed. The picture brightness can be automatically adjusted by the system according to the illumination intensity of the subject in real time, and it can be adjusted manually.The brightness level can be adjusted manually from 0 to 6 (the default is 2). Illumination will turn off when the brightness level is at the lowest level, and it will turn on when the brightness level is more than the lowest level.

The device set for skin imaging consists of:

• Camera handset
• Attachable DE

9.1 Steps for skin imaging:

1. Clean the lens and the part of the skin area to be photographed.

2. Hold the handset and hold the lens against the skin area of the patient to be tested.

3. Tap to enter adjust brightness function and turn wheel or drag the process bar to adjust brightness of the picture.

4. Click and drag one end of the ruler or hold the middle of the ruler and move it in parallel to adjust the ruler to the appropriate measurement angle and position.

5. Tap to select a capture mode.
   To take photos
   a) When photo mode is selected:
   • Tap to enter picture taking photo mode .
   • Tap again or turn the wheel to capture photo.
   • When the photo has captured, will change to , and the image will be saved in Wifi-SD (if used) or to the internal storage, if “Save” is selected in the pop-up window.
   If “Don‘t save” is selected, the image will be discarded.
   To record video
   b) When video mode is selected:
   • Tap to enter video capture mode .
   • Tap again or turn the wheel to start the video, and will change to .
   • Tap or turn the wheel to stop the video with showing the saving reminder information. And the video will be saved in Wifi-SD (if used) or in internal memory.

6. Tap **** to review the results of the photo or start the next photo.

7. After the photo is taken, clean the part of the lens that camera contact with the patient.

Imaging using optics module general lens (GE)

The RCS-100 camera with general lens has an object range of 30 mm ~ 4 m, is intended to capture digital images and video of mouth and throat.
The picture brightness can be automatically adjusted by the system according to the illumination intensity of the subject in real time, and it can be adjusted manually.
The brightness level can be adjusted manually from 0 to 6 (the default is 2). Illumination will turn off when the brightness level is at the lowest level, and it will turn on when the brightness level is more than the lowest level.
The device set for general imaging consists of:

• Camera handset
• Attachable GE

10.1 Steps for general imaging:

1. Hold the handle and move towards desired position. The lens should be about 35 mm from the required image.

2. Tap to adjust brightness . Turn wheel or drag the process bar to adjust the brightness of the picture.

3. Tap to select manual/auto focus.
   When is selected, click on the position in the preview area where you want to focus, the system will automati-cally focus according to the selected position.
   When is selected, turn the wheel or drag the focus progress bar on the touch screen to complete manual focus.

4. Tap to select a capture mode.
   a) When photo mode is selected:
   • Tap to enter picture taking photo mode.
   • Tap again or turn the wheel to capture photo
   • When the photo has captured,   will change ) ,and the image will be saved in Wifi-SD [if used) or to the in-ternal storage, if “Save” is selected in the pop-up window.
   If “Don’t save” is selected, the image will be discarded.
   b) When video mode is selected:
   • Tap to enter video capture mode .
   • Tap again or turn the wheel to start the video, and will change to .
   • Tap or turn the wheel to stop the video with showing the saving reminder information. And the video will be saved in Wifi-SD (if used) or in internal memory.

5. Tap **** to review the results of the photo or start the next photo.

Cleaning and disinfection

The device is a precision photoelectronic instrument thatshould be handled with care.
Please note the following cleaning instructions:

• Turn off the device before cleaning it.
• Disinfect the control unit and charging adapter with the soft cloth with little alcohol (70% ethyl alcohol). Wait for thecleaning liquid to evaporate before turning the power onand connecting the charging adapter and USB cable to thecontrol unit.
• It is recommended to clean the optical lens with a cleaning cloth or lens cleaning tissue, such as THORLABS Inc.(www.thorlabs.com) lens cleaning tissue.

Clean the position of dermatoscope lens which have been in contact with patient before each use:

• Disinfect dermatoscope lens head with the soft cloth with alcohol (70 % ethyl alcohol). Wait for the cleaning liquid to evaporate before attaching with handset.

Replace the specula before each use. If a replacement for the specula is needed, please contact the manufacturer or retailer.
Note:
The device is not intended to be sterilized.

Troubleshooting

• Failed lens recognition: When the main interface on the screen does not match the connected lens, disconnect the lens to confirm whether the lens connection pins and surfaces is abnormal or not. After confirming, connect the lens again.
• Illumination does not work: Please test the other lenses and confirm whether the illumination can be controlled.
• The handset can not turn on: Confirm that the battery is charged.
• Battery operating time is too short: Check the battery is in good condition.

Information a bout the device

RCS-100 is a portable and multifunctional electronic imaging diagnostic system. Which consists of a handset (5.0 inch, 720 p, multi-touch display, 3.6 V 2.600 mAh rechargeable battery, 1000 photo storage capacity), three kinds of replaceable lenses (Otoscope,
Dermatoscope, General).

Technical data

Size & weight| Size: 225mm135mm45mm
Weight: 292.0 g
---|---
LCD| 5.0 inch touch (110.7 mm 62.3 mm), 1280×720
Focus| automatic/manual
Image/video format| picture: JPEG, video: MP4
Battery| 3.7V 2600mAH 18650  li-battery
Video 3.5 hours (fully charged battery at 25℃ ambient temperature)
Adapt| input 100~240V 50~60Hz 0.3A
output DC 5V/2A
CMOS pixels| 8M
USB| OTG and type-C USB
RAM| 2G LPDDR3
Rom| 16G
Extend Memory(OPT)| 16G wifi SD card
Otoscope：
Size & weight| Size: 73.5mm40.0mm40.0mm Weight:96g
F/#| 2.9
Max object distance| 15mm, At max object distance FOV diameter: 15mm
Object height| 10mm (Ø4 specula)
Depth of field scope| 10mm
Lighting source| natural light LED
LED color temperature| 4000k
Dermatoscope：
Size & weight| Size:62.1mm62.1mm36.0mm Weight:108.5g
F/#| 2.2
Polarization:| Dermis / Epidermis
Object distance| 0mm
Field of view:| 30 mm Ø
Magnification| 2.5x
Photography source| natural light LED
LED color temperature:| 4000K
General：
Size & weight| Size:60.5mm60.5mm*19.0mm Weight:66.4g
F/#| 2.0
Field angle| 78°
Object distance| 30mm ~ 4m
Lighting source| natural light LED
LED color temperature| 5500K

Operation condition:

• For indoor use only
• Ambient temperature: 10°C to +40°C
• Relative humidity: 15 % to 95 %, rel. non-condensing
• Atmospheric pressure: 700 hPa ~ 1060 hPa
• Storage condition:
• Ambient temperature: 0°C to +45°C
• Relative humidity: 15 % to 95 %, rel. non-condensing

Note:
It is recommended to remove the battery if the device is stored over 2 weeks.

Environment

• Follow the local governing ordinances and recycling plans regarding disposal or recycling of device components. Especially when disposing of the lithium ion battery, circuit board, plastic parts that contain brominated flame retardant, LCD, or power cord,
  be sure to follow the local governing ordinances.

• When disposing of packing materials, sort them by material and follow local ordinances and recycling regulations.

• Inappropriate disposal may contaminate the environment.

• When disposing of specula, or contact plate, follow the disposal procedures for medical waste such as needles, infusion tubes, metal instruments for surgery as specified by your medical facility to avoid infection outside the facility
  and environmental pollution.

Standards

Electrical safety IEC 60601-1 2005 (EN 60601-1 2006) EMC and regulatory compliance IEC60601-1-2:2014
ELECTROMAGNETIC COMPATIBILITY
ACCOMPANYING DOCUMENTS ACCORDING TO IEC 60601-1-2, 2014, Ed. 4.0

EMC (electromagnetic compatibility)
The instrument satisfies the requirements for electromag- netic 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 IEC60601-1-2:2014 requirements.During installation and operation of the device, observe the following instructions:

• Do not use the device simultaneously with other electronic equipment to avoid electromagnetic interference with the operation of the device.
• Do not use or stack the device near, on, or under other electronic equipment to avoid electromagnetic interference with the operation of the device.
• 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.
• 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.
• Do not touch the pins connecting the control unit to the lenses or the signal pad on the lenses without special precautions.

Attention:
Medical electrical equipment (ME) 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 of home health care and intended for professional facilities such as industrial areas and hospitals.
The user of the device should ensure that it is operated within such an environment.
Warning:
The ME device may not be stacked, arranged or used directly next to or with other devices. When operation is required to be close to or stacked with other devices, the ME device and the other ME devices must be observed in order to verify proper operation within this arrangement.
This ME device is only intended for use by medical professionals. This device may cause harmful interference or interfere with the operation of nearby devices. It may become necessary to take appropriate measures, such as redirecting or re arranging the ME device or shield.
The ME device assessed does not exhibit any essential performance features in the sense of EN60601-1, which would present an unacceptable risk to patients, operators or third parties in the event that it should present an outage or the power supply should disconnect.
Warning:
Portable RF communications equipment (radios) including accessories, such as antenna cables and external antennas, should not be used in closer proximity to modules than specified by the RCS-100 parts and lines manufacturer 30 cm (12 inch). Failure to comply may result in a reduction in the device‘s performance features.
Table  1

Guidance and manufacturer’s declaration – electromagnetic emissions

The RCS-­100 is compliance for each EMISSIONS test specified by the standard, e.g. EMISSIONS class and group.
Emissions| Compliance| Electromagnetic environment-­-­ guidance
RF emissions CISPR 11| Group 1| The RCS-­100 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 emissions CISPR 11| Class B| The RCS-­100 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-­voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-­3-­2| Class A
Voltage fluctuations/ flicker emissions
IEC 61000-­3-­3| Complies

Table  2

Guidance and manufacturer’s declaration – electromagnetic immunity

The RCS-­100 is compliance for each IMMUNITY test specified by the standard, e.g. IMMUNITY test level.
Immunity test| IEC 60601-­1-­2 test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-­4-­2| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated RF EM fields IEC 61000-­4-­3| 10V/m
80 MHz -­ 2.7 GHz
80 % AM at 1 kHz| 10 V/m
80 MHz -­ 2.7 GHz
80 % AM at 1 kHz
Electrical fast transient/burst
IEC 61000-­4-­4| ±2 kV
100 kHz repetition frequency| ±2 kV
100 kHz repetition frequency
Surge
IEC 61000-­4-­5| ±0.5 kV, ±1 kV line-­to-­line;;
±0.5 kV, ±1 kV and ±2 kV line-­to-­ ground;;| ±0.5 kV, ±1 kV line-­to-­line;;
±0.5 kV, ±1 kV, and ±2 kV line-­to-­ ground;;
Conducted
disturbances induced
by RF fields
IEC 61000-­4-­6| 3 V
0.15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0.15 MHz and 80 MHz
80 % AM at 1 kHz| 3 V
0.15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0.15 MHz and 80 MHz
80 % AM at 1 kHz
Voltage dips, short
interruptions and
voltage variations
on power supply input lines
IEC 61000-­4-­11| 0 % UT: 0.5 cycle a)
At 0o, 45o, 90o, 135o, 180o, 225o,
270o, and 315o.| 0 % UT: 0.5 cycle a)
At 0o, 45o, 90o, 135o, 180o, 225o, 270o,
and 315o.
0 % UT: 1 cycle
70 % UT: 25/30 cyclesb)
Single phase: at 0o| 0 % UT: 1 cycle

70 % UT: 25/30 cyclesb)
Single phase: at 0o

0 % UT: 250/300 cyclesb)| 0 % UT: 250/300 cyclesb)
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-­4-­8| 30 A/m
50 Hz or 60 Hz| 30 A/m
50 Hz or 60 Hz
NOTE
a) UT  is the a.c. mains voltage prior to application of the test level;;
b) e.g. 25/30 means 25 periods at 50 Hz or 30 periods at 60 Hz.

Table  3  –  Test  specifications  for  ENCLOSURE  PORT  IMMUNITY  to  RF wireless communications  equipment

Test Frequency (MHz)| Band (MHz)| Service a)| Modulation b)| Maximum Power (W)| Distance (m)| IMMUNITY TEST LEVEL (V/m)| Compliance level
---|---|---|---|---|---|---|---
385| 380-­390| TETRA 400| Pulse
Modulation 18 Hz| 1.8| 0.3| 27| 27
450| 430-­470| GMRS 460
FRS 460| FM c)
±5 kHz deviation
1 kHz sine| 2| 0.3| 28| 28
710| 704-­787| LTE-­Band 13,
17| Pulse Modulation 217 Hz| 0.2| 0.3| 9| 9
745
780
810| 800-­960| GSM 800/900, TETRA 800,
Iden 820,
CDMA 850,
LTE Band 5| Pulse Modulation 18 Hz| 2| 0.3| 28| 28
870
930
1720| 1700-­1990| GSM 1800;;
CDMA 1900;;
GSM 1900;; DECT;;
LTE Band 1, 3,
4, 25;; UMTS| Pulse Modulation 217 Hz| 2| 0.3| 28| 28
1845
1970
2450| 2400-­2570| Bluetooth, WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Pulse Modulation 217 Hz| 2| 0.3| 28| 28
5240| 5100-­5800| WLAN 802.11
a/n| Pulse Modulation 217 Hz| 0.2| 0.3| 9| 9
5500
5785
NOTE:
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

WARRANTY

This product has been manufactured under the strictest quality standards and has undergone a thorough final quali-ty 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 defec-tive 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 or repair, please re-turn the Riester product with the completed warranty Card to the following address:
Rudolf Riester GmbH
Dept. Repairs RR
Bruckstr. 31
72417 Jungingen
Germany

Serial number or batch number
Date
Stamp and signature of the specialist dealer,

99365 Rev. C 2020-03
Subject to alterations
**** Rudolf Riester GmbH | Postfach 35 |
Bruckstraße 31 | 72417 Jungingen | Deutschland
Tel.: (+49) 7477-9270-0
Fax: (+49) 7477-9270-70
info@riester.de
www.riester.de

References

• Rudolf Riester GmbH - Medical devices of the highest standards.
• Thorlabs, Inc. - Your Source for Fiber Optics, Laser Diodes, Optical Instrumentation and Polarization Measurement & Control

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