Electronic baby scales M118000 and M118000-01 Rev002-UM-e Instructions for Use March 2021

1. Intended Use Your ADE electronic baby scale is a quality product and manufactured for determining weight (up to 15 respectively 20 kg) and optionally length (40 to 80 cm) of babies and toddlers, who cannot yet stand still on a personal scale by themselves without assistance. The scale may be used in all professional health care institutions, for medical, diagnostic and recovery purposes that require mandatory calibration. The maximum capacity of the scale is 15 respectively 20 kg. To achieve precise results, please read the user guide carefully and follow the instructions contained therein. The scale may only be operated and maintained by trained personnel. The device may only be used as intended. All applications of the device not mentioned in the chapter "Intended use" are considered as improper use. It is the user of the device, but not the manufacturer, who assumes liability for any resulting damage to property or personal injury resulting from misuse. The use of accessories other than the original accessories supplied by the manufacturer may void this warranty. Warning: This device may not be modified without the manufacturer's permission. During use, do not touch the mains adapter/battery and the baby to be weighed at the same time. Do not use the device in an oxygen-rich environment.

2. Safety Instructions 2.1

General Safety Instructions

Be sure to read, understand and follow all instructions in this manual and others that accompany the system and its components, as well as country-specific installation standards, applicable safety regulations and accident prevention rules. -

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Handle the scale with care and always keep in mind that it is a precision measuring instrument. Make sure that the baby to be weighed is centred on the weighing surface. Do not use the scale if one or more security marks are damaged. Do not use the scale if the calibration counter reading displayed when the scale is switched on does not match the number marked on the valid calibration counter mark. The scale may only be operated and maintained by trained and authorised skilled personnel. Before first use, make sure that the mains voltage and current type stated on the name plate match the mains voltage and current type at the place of use. Never touch baby and mains adapter simultaneous. Only the power adapters authorised by the manufacturer ADE may be used. Otherwise, there is a risk that other electrical devices will be affected. Only Bluetooth devices authorised by the manufacturer ADE may be connected. Otherwise, there is a risk that the specified performance level will be compromised. Anyone connecting additional equipment or power supply (other than specified in section 8) to the equipment is responsible that the system complies with the requirements of the standard IEC 60601-1. The plug/adapter connector isolates the device from the mains supply. Do not place the device in a position where it is difficult to disconnect the power supply to safely stop the operation of the device.

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Make sure that the mains cable is routed between the scale and the mains connection in such a way that there is no risk of stumbling. Make sure that the mains cable is routed between the scale and the mains connection in such a way that there is no risk of strangulation. Never push the scale back and forth without lifting, as this may cause damage to the load cells. Operate the device only within the permissible ambient conditions. After starting up the scale (connecting to the power supply or inserting the batteries), the scale must warm up for 15 minutes. Accuracy is only guaranteed after this time. Do not expose the scale to high temperatures, whether from neighbouring devices or direct sunlight. Use the scale at constant ambient temperatures and avoid using in draughts, otherwise the measurement results could be falsified. After storage under extreme conditions, allow at least 60 minutes for the scale to become acclimatised and ready for use as directed. If possible, place the scale away from other devices or sources that generate electromagnetic or other disturbances as these can falsify the measurement results. Use only approved accessories and peripherals. Before cleaning the device, disconnect the mains adapter from the mains. Do not immerse the device in water or other liquids. If the scale will not be used for a long time, it should be cleaned and stored in a protective film. The addition of a drying agent is desirable. Remove the batteries if you are not going to use the scale for a long time. If you have any problems with this device, such as problems with setup, maintenance or use, please contact your authorised dealer. Do not open or repair the device yourself. Please notify the authorised dealer if unexpected operations or events occur.

DO NOT use the scale: - If the mains adapter is damaged; - If the battery compartment has an unnatural bulge; - After long storage in a humid environment. In such cases, please contact an authorised customer support.

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2.2

Safety symbols Symbol

Meaning

Symbol

Meaning

Keep away from babies and toddlers! Do not pull over your head! There is a choking hazard!

Batteries/rechargeable batteries are not a toy. There is a choking hazard!

Pay attention to correct polarity. There is an explosion hazard!

Do not throw batteries/ rechargeable batteries into fire. There is an explosion hazard!

Do not damage batteries/ rechargeable batteries. There is an explosion hazard!

Do not damage batteries/ rechargeable batteries. There is an explosion hazard!

Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts. If you are allergic to plastic/rubber, please don’t use this device.

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Scope of delivery Check the scope of delivery for completeness immediately upon receipt of the scale: - Scale - 4 x 1.5 Volt AA batteries - Instructions for Use - Declaration of Conformity

Overview Measuring Calliper Weighing surface Spirit level Display Keypad

Battery compartment

Mains connection

Cable Guide

Levelling Feet

Illustration: dual-range scale

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4.1

Key names and functions Symbol

4.2

Description

Function

ON/OFF

ON/OFF Key: Switches the scale on and off.

ZERO / TARE

Multi-function key: ZERO key: Sets the scale to "ZERO". (Only for loads in the range -0.2 kg to +0.6 kg). TARE key: Enables the tare function. (Only for loads less than -0.2 kg or greater than +0.6 kg).

HOLD

HOLD key: Activates the automatic hold function.

LENGTH / WEIGHT

Multi-function key: L/W key: Toggles the display between weight and length determination. (Only for scales with length measuring system.)

TRANSMIT

TRANSMIT key: Transmits the measurement result to a compatible receiving device. (Only for scales with transmitter module.)

Display symbols

Symbol

Meaning Non-calibratable function! HOLD function determines weight from a sequence of measured values.

„Hold“

Hold function is activated.

„Net“

Tare function is activated.

>0<

The scale is in zero point. The weighing result is stable.

Kg / lb

Determined weight in "kilograms" or "pounds”.

´´ / cm

Determined body height in "inch" or "cm.

WI / WII

Indicates the weighing range (only for multi-range version). Indicates the transmission of the measurement result to the paired receiving device.

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Getting started with the scale Carefully unpack the scale and remove all packaging materials. Turn the scale over and insert four 1.5 V AA batteries supplied into the battery compartment. When inserting the batteries, make sure the polarity is correct (as shown in the battery compartment). For mains operation, connect the optional mains adapter to the mains connection. Insert the cable into the cable guides. A cable not inserted in the cable guides can lead to a force shunt and thus to incorrect measured values. After warm-up time (15 minutes) the scale is ready for operation. Place the scale on a level, stable surface. Align the scale using the levelling feet. Make sure that the air bubble of the spirit level is centred in the black frame. Check the horizontal position of the scale after every change of location!

How it works 6.1

Determination of Weight

The mechanical forces acting on the scales are transformed into measurable and evaluable electrical signals by load cells. The weighing result is displayed continuously. 6.2

Determination of Length

The physical change of the length measuring device causes a change in impedance and is thus converted into measurable and evaluable electrical signals. By linking the two calipers, it is irrelevant at which position they are located. The result of the length measurement is displayed continuously.

Using the scale 7.1

Starting the scale

To switch on the scale, briefly press the ON/OFF key. After a brief functional test, the scale shows "0.00 kg" and the symbol >0<. The scale is now ready for use. The scale starts automatically with the last function used. 7.2

Switching off the scale

7.2.1 Automatic switch off The scale switches off automatically after approx. 90 seconds in battery operation and after approx. 7 minutes in mains operation.

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7.2.2 Switching off with key To switch off the scale, press and hold down the ON/OFF key for about 2 seconds. The scale automatically saves the last settings used. 7.3

Correct weighing

Switch on the scale with no load. Wait for "0.00 kg" and the symbol >0< to appear on the scale display. Place the baby to be weighed as centrally as possible on the weighing surface. The weight can be read off directly after standstill. 7.4

Hold function

With the Hold function (automatic hold function), the determined weight is still displayed even after the scale is unloaded). Switch on the scale with no load. Wait for "0.00 kg" and the symbol >0< to appear on the scale display. Briefly press the HOLD key. The symbols appear on the display.

(non-calibratable function) and Hold additionally

Start the weighing process. The end of weight determination is indicated by the now flashing Hold symbol. The weighing result is permanently shown on the display (even after the scale has been unloaded) until the following weighing procedure or until the scale is (automatically) switched off. NOTES:

If multiple weighings shall follow each other in the hold function, it is not necessary to switch the hold function off and on again each time. However, the scale must have reached zero once before it is loaded again. When the scale shows the symbol >0< on the display, the next weighing can begin. If the weighing procedure was started without using the hold function, this can still be switched on by pressing the HOLD key even if the scale is already loaded.

To deactivate the hold function, briefly press the HOLD key. The symbols longer be displayed. 7.5

and Hold will no

Tare function

The tare function does not take into account any additional weight placed on the scale. Switch on the scale with no load. Wait for "0.00 kg" and the symbol >0< to appear on the scale display. Place the additional weight (e.g. towel) on the scale and briefly press the TARE key. The display will blink temporarily and then "0.00 kg" will appear on it. The symbol Net will light up on the display. Remove the additional weight from the scale. The display shows „-----“. Place the baby with the additional weight (e.g. towel) on the scale. The scale determines the weight of the baby without the additional weight.

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The value of the additional weight remains stored until the tare function or the scale is switched off. Make sure that, for example, additional towels only come in contact with the weighing surface. If a towel also comes in contact with the surface on which the scale is placed, the weight readings will be incorrect. To exit the tare function, briefly press the Tare key or switch off the scale. 7.6

Length measurement NOTE:

Length measurement is only possible using models with mounted measurement calipper. With other models, it is not possible to switch between weight and length measurement. The measuring function can also be upgraded. Please contact our customer service.

To switch to length measurement, briefly press the L/W key. The display shows the current measured length as well as the set unit. Pull both measuring callipers completely apart. Place the baby on the weighing surface. The exact position of the baby is irrelevant. Place the two measuring callipers on the baby’s head and feet. The display shows the measured length value. To exit the length measurement, briefly press the L/W key again. 7.7

Beep NOTE:

The beep tone is deactivated by default. If desired, you can activate the function. Please ask for the extended instructions.

If activated, a beep sounds when … … the scale is overloaded. … the scale is underloaded. … a key is pressed. 7.8

Bluetooth NOTE:

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The (optional) Bluetooth module is disabled at the factory. Information on activating and setting up the Bluetooth interface as well as pairing with other devices will only be announced once Bluetooth devices approved by ADE are available.

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Care and maintenance 8.1

Cleaning

Clean the device if required. Disconnect the mains plug before cleaning the scale. Use only a damp cloth or an ordinary disinfectant for cleaning. Do not use aggressive liquid cleaning agents, abrasive or acidic detergents. Make sure that no liquid cleaning agent or water penetrates the scale and always follow the manufacturer's instructions for use. 8.2

Disinfection

The display is made of polymethyl methacrylate (PMMA). PMMA is sensitive to alcohol and can become cloudy if unsuitable disinfectants are used on it. Only use disinfectants suitable for sensitive surfaces. Suitable disinfectants are available from specialist dealers. Ensure that the disinfectant is suitable for sensitive surfaces and polymethyl methacrylate (PMMA). Follow the instructions on the disinfectant. Disinfect the device at regular intervals using a soft cloth dampened with a suitable disinfectant. Component

Intervall

Tray

Before and After every measurement

Housing, controls and display

If required

8.3

Sterilisation

This device may not be sterilised. 8.4

Faults and error messages

8.4.1 Faults Fault

Cause

Measure

The display shows nothing.

The scale has switched off automatically.

Switch on the scale.

The display shows nothing.

Not connected to the mains.

Use the optional mains adapter to connect the scale to the mains.

The display shows nothing.

The battery is empty.

Insert new batteries.

The display shows nothing.

No battery is inserted.

Insert batteries.

The scale wobbles.

The scale is not levelled properly.

Adjust the leveling feet. Use the spirit level to check the horizontal position.

The displayed measurement results do not change or are obviously incorrect.

Wrong operating mode selected.

Toggle between weight and length measurement.

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8.4.2 Error messages Error message

Description

[Lo]

Empty battery.

[uLoad]

Underload (-20d)

Switch the scale off and on again.

[oLoad]

Overload (-9d)

Unload the scale. Zero range or weighing capacity exceeded

[no 0.00]

No zero point available.

Zero the scale.

Negative weight values (e.g. in the tare function) are not displayed.

Load the scale.

„-----“

Scale is loaded too slowly during the HOLD function.

Unload the scale. Wait until >0< is shown in the display. Load the scale again.

„-----“

8.5

Troubleshooting Insert new batteries. Use the scale in mains operation.

Maintenance

To ensure correct measurement, maintenance and repair should only be carried out by authorised personnel. To prevent the intended level of accuracy the product must be set up carefully and services regularly. We recommend having it serviced every 3 to 5 years depending on how often the scales are used. 8.6

Recalibration

According to the national regulations of the legislature, only authorized companies or authorized personnel can perform recalibration. On the CE mark, you can find the year of initial calibration next to the notified body (0122). Recalibration must be carried out when: 8.7

the calibration counter reading displayed when the scale is switched on does not match the number marked on the valid calibration counter mark, one or more security marks were damaged, after repair of a calibrated scale, after expiry of the period, set by the national regulations for recalibration. Storage and Transport Conditions

Keep all original packaging materials and components for eventual return of the scale to avoid damage during transport; these are not covered by the warranty. To avoid damage disconnect all cables before transport.

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8.8

Accessories

Item

Item description

Item number

Power adapter

UES06WOCP-060100SPA

H2870-006

Carrying bag

MZ10060

MZ10060

8.9

Warranty

You have a two-year warranty from the date of purchase against defects in materials and workmanship, the scale will be either repaired or replaced (please keep proof of purchase). All removable parts such as batteries, cables, mains adapter, rechargeable batteries etc. are not covered by the warranty. The warranty does not cover normal wear or damage caused by accident or misuse. Any warranty or liability claims are valid only if original ADE accessories and spare parts are used. Products that have been opened by unauthorised persons are not covered by the warranty. Foreign customers should contact the local dealer for warranty. 8.10

Disposal

Waste electrical equipment do not belong in household waste. Devices with this marking may not be disposed of as residual waste, but must be recycled. Remove (if possible) all batteries and rechargeable batteries from the devices and send them to the battery disposal. Make sure that only depleted batteries or batteries with insulated poles are disposed of so that there is no short circuit!

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9. Technical Data Power supply Mains operation: Mains voltage: Frequency: Supply Voltage: Current: Battery operation:

Use only with mains adapter UES06WOCP-060100SPA 100 – 240 V AC, 0.2A 50/60 Hz 6 V DC 1.0 A (max.) 4 x 1.5 V AA alkaline batteries (> 5000 measurements / >100 h operating time)

"Weight“ Measuring range

Single Range

Max. load capacity: Division: Accuracy:

15 kg 5g 0 ≤ 2,500 kg: 2,505 ≤ 10,000 kg: 10,010 ≤ 15,000 kg:

Dual Range

±5g ±10g ±15g

20 kg 5 g < 10 kg > 10g 0 ≤ 2,500 kg: 2,505 ≤ 10,000 kg: 10,010 ≤ 20,000 kg:

±5g ±10g ±20g

"Length“ Measuring range Measuring Range: Division: Accuracy:

39,8 – 80,2 cm 0,2 cm ±0,4 cm

Ambient conditions Operating temperature: Storage and Transport temperature: Humidity: Air pressure:

+10°C to +40°C -20°C to +60°C

Device classification Mode of operation: Degree of protection: Battery mode: AC adapter mode:

The combination of scale and adapter are specified as ME System. Adapter is considered as non-ME equipment part of ME System. Continuous operation Type BF applied part (scale top surface) Internally powered ME equipment Class II ME equipment

Software

The software version is displayed when the scale is switched on.

10% - 95% RH, non-condensing 700 hPa - 1060 hPa

Wireless: Frequency: Transmission power: Range:

2402 MHz to 2483.5 MHz +4 dbm 10 metres

Housing Dimensions: Net weight: Material: Protection class:

610 x 390 x 140 mm without length measuring system 655-1055 x 390 x 140 mm with length measuring system 3,5 kg / 3,7 kg without / with length measuring system ABS plastic IP21; the device is protected against solid foreign objects with a diameter of ≥ 12.5 mm. Protected against vertically falling drops of water or condensation.

Service life:

The design provides you with a service lifetime of 8 years.

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Symbol description Symbol

Meaning Instruction manual Follow instructions for use Manufacturer Date of manufacture Serial number CE marking

M 21

Marking according NAWI Directive 2014/31/EC with year of calibration

0122

Number of notified body registered according calibration requirements

0044

Number of notified body registered as medical device Class of calibration Type BF applied part

AC /

Alternating current

DC /

Direct current Warning

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11.

Electromagnetic compatibility

Electrical equipment is subject to special precautions regarding EMC and must be installed and commissioned in accordance with the guidance below. Portable and mobile HF devices (e.g. mobile phones) may affect medical electrical equipment. The use of third-party accessories may increase the emission or reduce the immunity of the device. Do not use mobile phones or similar devices that emit electromagnetic fields near the product. This could adversely affect the functionality of the product. Guidance and manufacturer's declaration - electromagnetic emissions This PRODUCT is intended for use in the electromagnetic environment specified below. The customer or the user of the PRODUCT should make sure that it is used in such an environment. Emission tests

Compliance

Electromagnetic environment – guidelines

HF emissions as per CISPR 11/EN55011

Group 2

The device must emit electromagnetic energy to perform its intended function. Electronic devices in the area can be affected.

HF emissions as per CISPR 11/EN55011

Class B

Harmonic emissions as per IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions as per IEC 61000-3-3

Complies

The PRODUCT is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration - electromagnetic immunity This PRODUCT is intended for use in the electromagnetic environment specified below. The customer or the user of the PRODUCT should make sure that it is used in such an environment. Immunity tests

IEC 60601 Test Level

Compliance level

Electromagnetic environment – guidelines

Electrostatic discharge (ESD) according to IEC 61000-4-2

± 8 kV contact discharge ± 15 kV air discharge

± 8 kV contact discharge ± 15 kV air discharge

Floors should be made of wood or concrete, or covered with ceramic tiles. If the floor is covered with synthetic material, the relative air humidity must be at least 30%.

Electrical fast transient/ burst as per IEC 61000-4-4

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

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

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

Surges according to IEC 61000-4-5

± 1 kV conductorconductor ± 2 kV conductor-earth

± 1 kV conductorconductor ± 2 kV conductorearth

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

Voltage drops, short-term interruptions, and fluctuations of the supply voltage according to IEC 61000-4-11

0% UT for 1/2 period (100% break-in) 0% UT for 1 period (100% break-in) 40% UT for 5 periods (60% break-in) 70% UT for 25 periods (30% break-in) 80% UT for 250 periods (20% break-in) 0% UT for 250 periods (short interruption)

0% UT for 1/2 period (100% break-in) 0% UT for 1 period (100% break-in) 40% UT for 5 periods (60% break-in) 70% UT for 25 periods (30% break-in) 80% UT for 250 periods (20% break-in) 0% UT for 250 periods (short interruption)

The quality of the supply voltage should correspond to that of a typical business or hospital environment. If the user of the PRODUCT requires continued operation even during power interruptions, it is recommended that the PRODUCT be supplied by an uninterruptible power source or a battery.

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Magnetic field at the supply frequency (50/60 Hz) according to IEC 61000-4-8

NOTE:

30 A/m

30 A/m

The line-frequency magnetic fields should correspond to the characteristics of a typical installation site in a commercial or clinical environment.

UT is the alternating mains voltage prior to the application of the testing level.

Guidance and manufacturer’s declaration - electromagnetic immunity This PRODUCT is intended for use in the electromagnetic environment specified below. The customer or the user of the PRODUCT should make sure that it is used in such an environment. Immunity Tests

HF conducted disturbances as per IEC 61000-4-6 HF radiated disturbances as per IEC 61000-4-3

Immunity Tests

3 Vrms 150 kHz to 80 MHz 10 V/m 80 MHz to 2.7 GHz

Immunity Tests

Immunity Tests Portable and mobile RF communications equipment should be used no closer to any part of the PRODUCT, including cables, than the recommended separation distance calculated from the equation applicable to the transmitter frequency. Recommended protective distance:

3 Vrms

= 1.2√

10 V/m

=

6

√

= 1.2√ 80 Mhz to 800 Mhz = 2.3√ 800 MHz to 2.7 GHz Where (P) is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer's specifications and d is the recommended separation distance in metres (m). The field strength of fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range.b In the vicinity of devices that bear the following pictorial symbol, interference is possible:

COMMENT 1

At 80 MHz and 800 MHz, the higher value shall apply.

COMMENT 2

This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

The field strength of fixed transmitters such as base stations for wireless telephones and mobile land radio services, amateur radio stations, AM and FM radio and television transmitters cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed HF transmitters, an electromagnetic site survey should be considered. If the field strength measured at the location of the PRODUCT exceeds the compliance level indicated above, the PRODUCT should be monitored for its normal operation at each place of use. If abnormal performance characteristics are observed, additional measures may be necessary such as reorienting or relocating the PRODUCT.

b

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

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Recommended separation distances between portable and mobile HF communications equipment and the PRODUCT The PRODUCT is intended for operation in an electromagnetic environment in which HF radiated disturbances are monitored. The customer or user of the PRODUCT can help prevent electromagnetic interferences by maintaining minimum distances between portable and mobile HF communications equipment (transmitters) and the PRODUCT as recommended below, according to the maximum output power of the communications equipment. Nominal power of the transmitter (W)

Separation distance according to transmitter frequency (m) 150 KHz to 80 MHz 80 MHz to 800 MHz

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

= . √

= , √

800 MHz to 2.7 GHz = , √

F For transmitters whose maximum output power is not listed in the table above, the distance can be determined using the equation specified in the respective column, where P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer's specification. COMMENT 1

An additional factor of 10/3 has been used to determine the recommended separation distance of transmitters in the frequency range of 80 MHz to 2.7 GHz in order to reduce the likelihood that a mobile/portable communication device placed inadvertently in the patient area will result in interference.

COMMENT 2

This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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CE marking and declaration of conformity ADE products are manufactured to the latest technical standards and with a long service life according to European standards and directives for worldwide products.

Declaration of conformity by the manufacturer ADE hereby declares under its sole responsibility that the M118000(S) and M118000-01(S) electronic baby scale complies with the directives 92/42/EEC, 2014/30/EU, 2014/31/EU, 2014/35/EU, 2014/53/EU and 2011/65/EU. The declaration will lose its validity if any modification is made to the device without our approval. The full text of the EU declaration of conformity is available at the following Internet address: www.ade-germany.de/DoC

Hamburg, April 2020 ADE Germany GmbH Neuer Hoeltigbaum 15 D-22143 Hamburg

Contact information of the manufacturer Manufacturer:

ADE Germany GmbH Neuer Hoeltigbaum 15 22143 Hamburg/Germany

Fon: Fax:

+49 40 432 776 - 0 +49 40 432 776 - 10

E-Mail:

[email protected]

Internet:

www.ade-germany.de

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