MedCenter 5000 Wandstation Users Manual May 2021

230 V

120 V

6

230 V

Ø 4 mm

Ø 2,5 mm

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User's Manual Wall-Mounted Charging Station KaWe MedCenter 5000 Dear buyer! Thank you for choosing a KaWe product. Our products are known for high quality and durability. This KaWe device complies with the provisions of Directive EU 2017/745 (European Directive on Medical Devices), whereby it is classified as a medical product of class 1. Please carefully consider this instruction and read all the provisions prior to use. Follow the warning instructions. Application: Only authorized qualified personnel can use the wall station. Intended use: The wall station is used to supply voltage to KaWe otoscope heads & ophthalmoscope heads with 3.5 V lamps. The wall control can be extended by up to three more handles.

9. Secure the back panel of the end frame by tightening the screws with a screwdriver. 10. Attach the front panel to the end frame. 11. To disassemble, disconnect the wall station from the power supply. After that, first remove the front panel. To do this, at the base of the end frame, slightly press the locking tab up with a slotted screwdriver and remove the front panel. Remove the screws while holding the unit. Slide the base unit upwards and remove it from the mounting plate. Information: The diagnostic heads are equipped with KaWe PICCOLIGHT screw locks. They can be screwed onto the handles. To protect against theft, the heads are secured with side set screws. To remove the head, loosen the set screw and unscrew the diag-nostic head.

Group of patients with indications for use: All Improper use of the device/contraindications for use: Any other method of use or use for purposes other than intended is considered improper. The manufacturer is not responsible for damage resulting from such use. In this case, only the operator assumes all risks. Use only the supplied handle for the supply voltage. Assembly/Disassembly: Use only the included components for the assembly of KaWe MedCenter 5000. 1. Hold the mounting plate horizontally on the wall and mark 3 anchor holes. 2. Drill holes with a Ø 6 mm drill to a depth of approx. 35 mm and insert the anchors. 3. Secure the mounting plate by tightening the screws with a screwdriver. 4. Place the base unit disconnected from the mains on the sheet strip, press it down and slide it down gently until it stops. 5. Check that the base unit is securely fastened. 6. When using an add-on unit: Affix it on the right side of the base unit. The add-on unit is secured by the guides of the base unit and the hinge of the end frame. Hold the add-on unit, attach the end frame and mark the holes. Remove the add-on unit before drilling the holes. 7. Drill holes with a Ø 6 mm drill to a depth of approx. 35 mm and insert the anchors for the end frame. 8. Attach the add-on unit and end frame to the base unit as described in Step 6 and secure it with screws.

Commissioning/Handling: 1. Connect the power cord to the local power outlet. 2. The green ready-to-operate indicator on the base unit will light up. 3. The backlight in the diagnostic heads automatically lights up when it is removed from the console. 4. The brightness of the backlight can be adjusted by pressing the (+/-) switch. 5. Two diagnostic devices can be used at the same time independently of each other. Make sure that the cords do not cross. 5..Two diagnostic devices can be used at the same time independently of each other. Make sure that the cords do not cross. At the head of the KaWe PICCOLIGHT C otoscope, slide the magnifier upwards and remove the lamp on the adapter. Disconnect the lamp from the adapter. If necessary, clean the glass bulb of the new lamp with alcohol. Insert the lamp with the adapter as far as it will go.

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Unscrew the safety screw at the upper side end of the handle. Remove the KaWe PICCOLIGHT F.O. otoscope head from the handle and remove the lamp. If necessary, clean the glass bulb of the new lamp with alcohol. The glass bulb shall be clean and free from fingerprints (grease spots). Put the lamp all the way in. Unscrew the safety screw at the upper side end of the handle. Unscrew the KaWe PICCOLIGHT ophthalmoscope head from the handle. Remove the lamp and insert the new incandescent lamp as far as it will go. Technical data for KaWe MedCenter 5000: Power supply unit with a plug... Type UES12LCP-050200SPA Input voltage range... ..100–240 V~, 50/60 Hz Output voltage...5.0 VDC Output current...max. 2 A Cord length... 3 m Protection rating...II Base unit (with end frame): Base unit dimensions (WxHxD)...206 x 146 x 100 mm Spiral cord effective length ...2800 mm (700 mm spiral length) Weight...about 810 g Add-on unit: Add-on unit dimensions (WxHxD)...80 x 146 x 100 mm Spiral cord effective length ...2800 mm (700 mm spiral length) Weight...about 370 g Ear funnel unit: Ear speculum unit dimensions (WxHxD)...80 x 146 x 100 mm Weight...about 200 g Environmental conditions during use:

Temperature ... +10 °C to +40 °C Relative humidity ...10 % to 75 % Atmospheric pressure ...700 to 1060 hPa Lagerbedingungen und Transport:

Temperature ... -10 °C bis +60 °C Relative humidity ...10 % to 95 % Atmospheric pressure... 700 to 1060 hPa

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Warnings: • The device is maintenance free. The housing can only be opened at the end frame to accommodate add-on units. Repairs may only be carried out by qualified personnel. • Only two KaWe MedCenter 5000 handles can be used at a time! • The device has no connection components. • In case of visible damages, remove the plug from the outlet immediately. The power supply is a separating device and must be disconnected from the mains if there is visible damage to the device. • The power supply unit must always be accessible. • The wall station is not intended for operation in hazardous areas and under the influence of intense magnetic fields, as well as in operating rooms. • Take care not to trip over the spiral cord. Use on escape routes is prohibited. • Only KaWe components may be used. It is forbidden to modify the design of the device. • During the examination, the user must not touch live parts such as the plug or screw lock of the diagnostic device. • If the lamps are lit for a long time (> 1 min), the metal surface of the handle becomes very hot, which, if it comes into direct contact with the skin, may cause burns, or if the handle is placed on surfaces that are sensitive to high temperatures, it may catch fire. Please note that after each use the handles must be returned in their respective slots and the lights must be turned off. Allow the handles to cool down after prolonged use. • To prevent heating of the surface of the handles, the device automatically turns off after 3 minutes. Activate it again by pressing a button on the handle or by placing it in the wall console. • When working with the wall station, special precautions regarding electromagnetic copatibility must be observed. • Portable and mobile high frequency telecommunication devices may interfere with the operation of the wall station. • The ear funnels of the ear funnel unit are for single use only and must not be reused. • The otoscope can be used to examine patients only with an installed ear funnel.

Instructions Transportation and storage: To prevent contamination and dust, store the device only in its packaging before installation

Warranty: The warranty for the device totals two years from the date of purchase with proper handling and following the User’s Manual. If any issues arise or repair is necessary, please contact your dealer.

Preparation for cleaning: No special requirements.

General accessories: To find out more about these products, visit our homepage: www.kawemed.com

Manual cleaning: The wall station and diagnostic devices can be cleaned from the outside with a damp, soft and lint free cloth. Use soapy water or other non corrosive products for cleaning. Clean the otoscope magnifying glass with a glass detergent only

Basic UDI-DI: 4030155KaWe02SL Symbol key: Manufacturer

Automatic cleaning: Automatic cleaning is not possible/not required.

Date of manufacture LOT Lot code

Disinfection: The housing can be wiped clean with a surface disinfectant. The surfaces must be wiped dry.

Separate disposal of electric and electronic devices SN Serial number

Sterilization: Sterilization is not possible/not required.

Please follow the User’s Manual CE conformity mark

Control and functional check: Check the smooth travel of moveable parts, such as magnifying glass frame and plugs. Turn diagnostic devices on. For all the parts of the units: Visually check for damages and wear. Remove or replace the damaged parts.

Protection rating II Temperature range Keep dry

Package: Packaged in molded tabs and bubble wrap boxes.

GOST-R certification of export goods imported into Russia

Additional information: Please note that the KaWe MedCenter 5000 wallmounted station must be installed in such a way that no one can be caught on it when passing by. The suspension height should ensure that the device is out of the reach of children.

Use the device only in dry rooms Article number Medical device

Manufacturer: KaWe Manufacturer’s contact details: Dealer’s address or phone number: +49-7141-68188-0. Information for users and patients All serious incidents involving this device must be immediately reported to the manufacturer and the competent authorities of the respective Member State in which the user and/or pa-tient is located. Additional information, maintenance and storage: The device will serve for years with proper handling and storage. Only KaWe spare parts and accessories may be used for KaWe otoscopes/ophthalmoscopes.

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Guidelines and manufacturer declaration – electromagnetic emissions The KaWe MedCenter 5000 is designed to be used in the types of electromagnetic environments listed below. The customer or user is responsible for ensuring that this device is used in such an environment. Emissions Measurement

Conformity

Electromagnetic environment – guidelines

Type-CISPR 11 – high-frequency emissions

Group 1

The KaWe MedCenter 5000 uses high-frequency energy solely for its internal operation. Its high-frequency emissions are therefore very low and it is unlikely that any nearby electronic equipment will be adversely effected.

Type-CISPR 11 – high-frequency emissions

Class B

Harmonic oscillations according to IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions according to IEC 61000-3-3

Complies

The KaWe MedCenter 5000 is designed for use in all facilities including living spaces that are directly connected to a public low-voltage power supply network that also supplies power to buildings used for domestic purposes.

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Guidelines and manufacturer declaration – electromagnetic interference immunity The KaWe MedCenter 5000 is designed to be used in the types of electromagnetic environments listed below. The customer or user is responsible for ensuring that this device is used in such an environment. Interference immunity test

IEC 60601test level

Compliance level

Electromagnetic environment – guidelines

ELECTROSTATIC ± 6kV contact discharge DISCHARGE (ESD) accor± 8 kV air discharge ding to IEC 61000-4-2

The flooring should be wood or concrete or be covered ± 6kV contact discharge with ceramic tile. If the floor material is a non-conductive, synthetic material, the relative humidity of the air ± 8 kV air discharge must be at least 30%

Fast transient electrical disturbances/ bursts according to IEC 61000-4-4

± 2kV for power supply lines ± 1kV for input and output lines

± 2kV for power supply lines ± 1kV for input and output lines

Surges according to IEC 61000-4-5

± 1kV phase-tophase voltage ± 2kV phase-to-ground voltage

± 1kV phase-toThe quality of the mains supply voltage should be phase voltage the same as that of a typical commercial or hospital ± 2kV phase-to-ground environment. voltage

<5% UT for 1/2 period (>95 % dip)

<5% UT for 1/2 period (>95 % dip)

40 % UT for 5 periods (60 % dip)

40 % UT for 5 periods (60 % dip)

70% UT for 25 periods (30 % dip)

70% UT for 25 periods (30 % dip)

<5 % UT for 5 ѕ (>95 % dip)

<5 % UT for 5 ѕ (>95 % dip)

Voltage dips, short interruptions and voltage variations on power supply input lines according to IEC 61000-4-11

Magnetic field with a power frequency of (50/60 Hz) according to IEC 61000-4-8

3 A/m

The quality of the mains supply voltage should be the same as that of a typical commercial or hospital environment.

The quality of the mains supply voltage should be the same as that of a typical commercial or hospital environment. If the user requires continued operation during power interruptions, it is recommended that the device be powered from an uninterruptable power supply or a battery.

Should interference occur, it may be necessary to place the KaWe MedCenter 5000 further from the source line frequency magnetic fields or to fit it with a magnetic shield: the line frequency magnetic field should be measured at the intended use site to ensure that it is not large enough to cause a disturbance.

3 A/m

Note: UT is the mains voltage prior to application of the test level.

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Guidelines and manufacturer declaration – electromagnetic interference immunity The KaWe MedCenter 5000 is designed to be used in the types of electromagnetic environments listed below. The customer or user is responsible for ensuring that this device is used in such an environment. Interference immunity test

Conducted HF-interference according to IEC 61000-4-6

HF-interference according to IEC 61000-4-3

IEC 60601test level

Compliance level

Electromagnetic environment – guidelines Portable and mobile HF communications equipment should be used no closer to the KaWe MedCenter 5000 (including its power cords) than the recommended separation distance. The separation distance is calculated using various equations depending on the transmission frequency.

3 V rms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 V rms

Recommended separation distance: d = 1.2 √P

3 V/m

d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz “P” is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. “d” is the recommended separation distance in meters (m). Field strengths from fixed transmitters, as determined by an electromagnetic survey of the site (a) are less than the compliance level (b) in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: For 80 MHz and 800 MHz, the larger of the two values 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 land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted with accuracy in theory. It is recommended that in order to assess the electromagnetic environment caused by fixed HF transmitters, an electromagnetic site survey should be conducted. If the measured field strength at the location at which the KaWe MedCenter 5000 is used exceeds the applicable compliance level stated above, the equipment should be checked at each of its locations of use in order to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the KaWe MedCenter 5000. b: For frequencies ranging from 150 kHz to 80 MHz, the field strength is less than 3 V/m.

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Recommended Separation Distances Between Portable and Mobile HF Communications Equipment and the Wall Station KaWe MedCenter 5000 The KaWe MedCenter 5000 is intended for use in an electromagnetic environments in which radiated HF disturbances are controlled. The customer or the user of the equipment can help prevent electromagnetic interference by ensuring that the minimum distance (shown below) between communications equipment (transmitters) and the KaWe MedCenter 5000 is maintained. The minimum distance is dependent on the maximum output power and the frequency of the communications equipment. Separation Distance According to Transmitter Frequencies (m) Rated Power Output of Transmitter (W)

150 kHz to 80 MHz d = 1.2√P

150 kHz to 80 MHz d = 1.2√P

150 kHz to 80 MHz d = 2.3√P

0.01

0.12

0.12

0.23

0.10

0.38

0.38

0.73

1

1.20

1.20

2.30

10

3.80

3.80

7.30

100

12

12

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For transmitters rated at a maximum output power not listed above, the recommended separation distance can be determined using the equation applicable to the frequency of the transmitter. P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the frequency bands between 80 MHz and 2.5 GHz in order to decrease the likelihood that mobile/portable communications equipment could cause interference if they are inadvertently brought into patient areas. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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