M322600 - Scale ADE - Free user manual and instructions

Product type	Class III electronic scale for professional use
Brand	ADE
Model	M322600
Dimensions	400 x 350 x 65 mm
Net weight	4.2 kg
Max capacity	250 kg
Divisions	100 g
Precision	±100 g (0-50 kg), ±200 g (50-200 kg), ±300 g (200-250 kg)
Power supply	4 AA 1.5 V batteries or 6 V DC power adapter (optional)
Battery life	> 5000 weighings or > 100 hours
Display	LCD, backlit, with pivot function (Turning)
Functions	Simple weighing, mom/baby function, Hold function, optional Bluetooth
Turn on	By key or by tapping (Touch to start)
Auto-off	90 s (battery) / 7 min (mains)
Cleaning	Damp cloth or suitable disinfectant (avoid alcohol on PMMA screen)
Disinfection	Disinfectant for sensitive surfaces, PMMA screen
Sterilization	Not allowed
Operating temperature	+10 °C to +40 °C
Storage temperature	-20 °C to +60 °C
Humidity	10% - 95% RH
Housing material	ABS plastic
Protection class	IP20
Applied part	Type BF (top surface)
Warranty	2 years parts and labor (excluding batteries, cord, adapter)
Included accessories	4 leveling feet, 4 AA batteries, instruction manual

Frequently Asked Questions - M322600 ADE

How to turn on the ADE M322600 scale?

You can turn on the scale by briefly pressing the ON/OFF key or by tapping the weighing surface with your foot (Touch to start function). After a check, the screen displays 0.00 kg.

What to do if the screen remains blank?

Check that the main switch under the scale is activated. If using batteries, ensure they are correctly installed and not discharged. In mains mode, plug in the optional adapter.

How to use the mom/baby function?

Turn on the scale, wait for 0.00 kg, then press the M/C key. Step onto the scale to record your weight (the scale tares automatically). Step off, pick up the child, and step back on. The child's weight is displayed.

How to rotate the display with the Turning function?

Briefly press (less than one second) the ON/OFF key during weighing. The display rotates 180° for easy reading from the other side.

Does the scale have Bluetooth connection?

A Bluetooth module is available as an option. It is disabled at the factory. To activate and pair it, consult the manufacturer or customer service. Detailed instructions will be provided with approved Bluetooth devices.

How to clean and disinfect the scale?

Unplug the scale. Use a damp cloth or a disinfectant suitable for sensitive surfaces. Avoid harsh products and alcohol on the PMMA screen (risk of cloudiness). Never immerse the device.

What do the error messages [Lo] and [oLoad] mean?

[Lo]: batteries low, replace them or use the power adapter. [oLoad]: overload, remove the load immediately (max 250 kg). If the problem persists, turn off and on again.

How to level the scale?

Screw the 4 leveling feet under the scale. Place it on a flat surface and turn the feet until the bubble in the spirit level is centered in the black circle.

What is the warranty for the ADE M322600 scale?

The warranty is 2 years from the date of purchase, covering parts and labor. Excluded: batteries, cord, adapter, normal wear, and accidental damage. Opening by an unauthorized person voids the warranty.

Can I use the scale without batteries on mains power?

Yes, you can use the optional mains adapter (ref. H2870-006, 6 V DC). Plug it into the supplied socket. The scale then operates without batteries.

USER MANUAL M322600 ADE

1. Intended use 21
2. Safety information 21

2.1 General safety instructions 21
2.2 Safety symbols 23

1. Scope of delivery 24
2. Overview 24

4.1 Key names and functions 25
4.2 Display symbols 25

1. Getting started with the scale 25
   6.How it works 26

2. Using the scale 26

7.1 Starting the scale 26
7.2 Switching off the scale 26
7.3 Correct weighing 26
7.4 Turning function 26
7.5 Mother/child function 27
7.6 Beep 27
7.7 Bluetooth 27

8.Care and maintenance 28

8.1 Cleaning 28
8.2 Disinfection 28
8.3 Sterilisation 28
8.4 Faults and error messages 29
8.5 Maintenance 29
8.6 Storage and Transport Conditions 29
8.7 Accessories 30
8.8 Disposal 30
8.9 Warranty 30

1. Technical Data 31

2. Symbol description 32

3. Electromagnetic compatibility 33
4. CE marking and declaration of conformity 36
5. Contact information of the manufacturer 36

1. Intended use

Your ADE electronic personal scale is a prime quality product designed for weighing of people who can step on the scale by themselves. In addition, the person must be able to stand firm and unaided on the scale throughout the weighing process. The integrated mother/child function allows the weighing of toddlers held by the mother or any other person.

The scale may be used in all professional health care environments for control purposes.

The maximum capacity of the scale is 250kg . 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.

Do not touch the mains adapter outlet connector/battery and the person on the scale at the same time during weighing.

Do not use the device in an oxygen-rich environment.

A Class III calibrated scale must be used for medical, diagnostic and curative purposes.

2. Safety information

2.1 General safety instructions

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

• Handle the scale with care and always keep in mind that it is a precision measuring instrument.
• Make sure, the patient is centered on the scale.
• 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.
• Only authorised ADE power adapters 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 9) to the equipment is responsible that the system complies with the requirements of the standard IEC 60601-1.
• The plug/adapter plug insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of me equipment.
• Make sure to lay the power cord between the scale and mains connection so as to preclude a tripping hazard.

• Make sure to lay the power cord between the scale and mains connection so as to preclude a strangulation hazard.

• Never move the scale back and forth at the place of use as this may cause damage to the load cells.

• Operate the device only within the permissible ambient conditions.
• Do not expose the scale to high temperatures, whether from neighbouring devices or direct sunlight. The liquid crystal display may suffer damage.
• Use the scale at constant ambient temperatures and avoid using in draughts, otherwise the measurement results could be falsified.
• After Storage under extreme conditions at least 30 min required until the scale has acclimated and is ready for intended use.
• 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. The use of unauthorised accessories or cables will invalidate the classification of the scale as a medical device.
• 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 setting up, maintaining or using, please contact authorised customer support. Do not open or repair the device by yourself.
• Please report authorised customer support if any unexpected operation or events occur.

DO NOT use the scale:

• If the mains adapter is damaged;
• If the mains adapter is not working;
• If the battery compartment has an unnatural bulge;
• After long storage in a humid environment.

In such cases, please contact authorised customer support.

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.

3. Scope of delivery

Check the scope of delivery for completeness immediately upon receipt of the scale:

• Scales
• 4 support feet
• 4 x 1.5 V AA batteries
  -User Guide with Declaration of Conformity

4. Overview

4.1 Key names and functions

Symbol	Description	Function
Turning	ON/OFF	Multi-function key: : The function of this key is switching on the scale. Turning: While in operation, this key is used to turn the displayed values.
	M/C	Mother/child key: Enables the mother/child function.

4.2 Display symbols

Symbol Meaning
	Mother/child function: The sign appears when the mother/child function is enabled.
"Net"	Tare function: The sign appears when the sare function is enabled. The display shows the net weight.
	Mother/child function: The sign appears when the child's net weight is displayed.
>0< The scale is in zero position.
~	The weighing result is stable.
"kglb" Measured weight in kilograms (kg) or pounds (lb).

5. Getting started with the scale

Carefully unpack the scale and remove all packaging materials.

Turn the scale over and screw the 4 support feet into the dedicated threads at the bottom of the scale.

Insert the 4 supplied 1.5V AA batteries in the battery compartment. When inserting the batteries, pay attention to the correct polarity (as shown in the battery compartment) and that the insulation of the batteries is undamaged.

For mains operation, connect the optional mains adapter to the mains connection.

Use the main switch to switch on the scale. The scale is now ready for use.

Place the scale on a level, stable surface.

Align the scale using the support 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!

6. How it works

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

7. Using the scale

7.1 Starting the scale

7.1.1 Main switch

The main switch at the bottom of the scale must be switched on. The switch serves only as transport protection for the scale.

7.1.2 Per key

To switch on the scale, briefly press the ON/OFF key.

After a brief functional test, the scale will show "0.00 kg" and the symbol >0< .

The scale is now ready for use.

The scale will start automatically with the last function used. When used for the first time, the scale will start automatically with the hold function.

7.1.3 Tap to start

Briefly load the weighing surface of the scale by briefly "tapping" it with your foot. If done correctly, a short functional test will follow, at the end of which the scale will show "0.00 kg" and the symbol >0< . The scale is ready for use.

7.2 Switching off the scale

7.2.1 Automatic switch off

The scale will switch off automatically after 90 seconds in battery mode and after 7 minutes in mains operation.

7.2.2 Per key

To switch off the scale, press and hold down the ON/OFF key for about 2 seconds.

The scale will automatically save the last function 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.

Stand as firm as possible on the weighing surface. The weight can be read off directly after standstill.

7.4 Turning function

To turn the display indication, briefly press the ON/OFF key (<1 second).

7.5 Mother/child function

Switch on the scale with no load. Wait for "0.00 kg" and the symbol >0< to appear on the scale display.

Press the M/C key. The M/C symbol will appear on the display. Stand as firm as possible on the scale. The scale will save the weight reading and display "0.00 kg". In addition, the symbol Net will appear. When unloading the scale, the net weight displayed will be negative. Now take a child by the hand and have them step on the weighing surface again. The weight will be automatically stabilised and the child's weight will be displayed. When unloading the scale, the blinking weight reading with the symbol Hold will still be displayed. Press the Tare key again to exit the tare function.

7.6 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.

7.7 Bluetooth

NOTE: 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.

8. 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, 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.	"Tap" or switch on the scale.
The display shows nothing.	The main switch is not switched on.	Switch on the main switch.
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 display indication shows cryptic characters.	The display is in "Turning mode". Press the Turning key.
The scale wobbles. The scale is not levelled properly.		Adjust the support feet. Use the spirit level to check the horizontal position.

8.4.2 Error messages

Error message Description	Troubleshooting
[Lo] Empty battery. Insert new batteries.		Use the scale in mains operation.
[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.

8.5 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 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.

Disconnect all cables before transport and use the mains switch on the back of the scale to switch it off to avoid damage.

8.7 Accessories

Item Item description Item number
Power adapter UES06WOCP-060100SPA H2870-006
Carrying bag MZ10062 MZ10062

8.8 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!

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.

9. Technical Data

Power supply
Mains operation:	Use only with Mains Adapter UES06WOCP-060100SPA
Mains voltage:	100 - 240 V AC, 0.2A
Frequency:	50/60 Hz
Adaptor voltage output:	6 V DC
Adaptor current output:	1.0 A (max.)
Battery operation: 4 x 1.5 V AA alkaline batteries (>5000 measurements / >100 h operating time)
Measuring range
Max. load capacity:	250 kg
Division:	100 g
Accuracy:	0≤50,0kg: 50,1kg≤200,0kg:	200,1≤250,0kg:
	±100g	±200g
		±300g
Ambient conditions
Operating temperature:	+10°C to +40°C
Storage and Transport temperature:	-20°C to +60°C
Humidity:	10% - 95% RH
Air pressure:	700 hPa - 1060 hPa
Device classification The combination of adapter and main unit are specified as an ME EQUIPMENT. Adapter is considered as part of ME equipment.
Mode of operation:	Continuous operation
Degree of protection:	Type BF applied part (scale top surface)
Battery mode:	Internally powered ME equipment
AC adapter mode:	Class II ME equipment
Software:	The software version is displayed when the scale is switched on.
Wireless:
Frequency:	2402 MHz to 2483.5 MHz
Transmission power:	+4 dbm
Range:	10 metres
Housing
Dimensions:	400 x 350 x 65 mm
Net weight:	4.2 kg
Material:	ABS plastic
Protection class:	IP20; the device is protected against solid foreign objects with a diameter of ≥ 12.5 mm. It is not protected against water drops.
Service Lifetime:	The design provides you with a service lifetime of 8 years.

10. Symbol description

Symbol

0044

AC/

DC/

Meaning

Instruction manual

Refer to Instruction Manual

Manufacturer

Date of manufacture

CE mark, complies with MDD 93/42/EEC requirements

Serial Number

Number of notified body registered as medical device

Type BF applied part

Alternating current

Direct current

Warning indication

11. Electromagnetic compatibility

Medical 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 - guidance
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	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.
Harmonic emissions as per IEC 61000-3-2	Class A
Voltage fluctuations/flicker emissions as per IEC 61000-3-3	Complies
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 606	01 Test Level Compliance	evel	Electromagnetic environment - guidance
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 conductor-conductor ±2 kV conductor-earth	±1 kV conductor-conductor ±2 kV conductor-earth	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)
Magnetic field at the supply frequency (50/60 Hz) according to IEC 61000-4-8	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.

NOTE: 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	IEC 60601 Test Level	Compliance level	Electromagnetic environment - guidance
HF conducted disturbances as per IEC 61000-4-6	3 Vrms150 kHz to 80 MHz	3 Vrms	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: d = 1.2√Pd = 6/E
HF radiated disturbances as per IEC 61000-4-3	10 V/m80 MHz to 2.7 GHz	10 V/m	d = 1.2√P 80 Mhz to 800 Mhzd = 2.3√P 800 MHz to 2.7 GHzWhere (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.bIn 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.
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 MHzd = 1.2√P	80 MHz to 800 MHzd = 1.2√P	800 MHz to 2.7 GHzd = 2.3√P
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
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.

12. 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.

C E

Declaration of conformity by the manufacturer

ADE hereby declares under its sole responsibility that the electronic personal scale M322600 complies with the directives 93/42/EEC, 2014/30/EU, 2014/35/EU, 2014/53/EU, and 2011/65/EU. The full text of the EU declaration of conformity is available at the following Internet address: www.ade-germany.de/DoC

The declaration loses its validity if modifications have been made to the device without our approval.

Hamburg, April 2021

ADE Germany GmbH

13. Contact information of the manufacturer

Manufacturer:

ADE Germany GmbH

Symbole Signification Symbole Signification

...la balance est surcharge.

Fabricant: ADE Germany GmbH

Neuer Höltigbaum 15

7.1.1 Interruptor principal

Apparaatclassificatie The combination of adapter and main unit are specified as an ME EQUIPMENT. Adapter is considered as part of ME equipment.

Material: ABS plastic

Medical 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	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.
Harmonic emissions as per IEC 61000-3-2	Class A
Voltage fluctuations/flicker emissions as per IEC 61000-3-3	Complies

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 606	1 Test Level Compliance	evel	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 conductor-conductor ±2 kV conductor-earth	±1 kV conductor-conductor ±2 kV conductor-earth	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 1/2 period (100% break-in)	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.
	0% UT for 1 period (100% break-in)	0% UT for 1 period (100% break-in)
	40% UT for 5 periods (60% break-in)	40% UT for 5 periods (60% break-in)
	70% UT for 25 periods (30% break-in)	70% UT for 25 periods (30% break-in)
	80% UT for 250 periods (20% break-in)	80% UT for 250 periods (20% break-in)
	0% UT for 250 periods (short interruption)	0% UT for 250 periods (short interruption)
Magnetic field at the supply frequency (50/60 Hz) according to IEC 61000-4-8	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.

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

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.

Guidance and manufacturer's declaration - electromagnetic immunity

Immunity Tests IEC	60601 Test Level	Compliance level	Electromagnetic environment – guidelines
HF conducted disturbances as per IEC 61000-4-6	3 Vrms150 kHz to 80 MHz 3Vrms	Vrms	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:d=1.2√Pd=6E√Pd=1.2√P80 Mhz to 800 Mhzd=2.8√P800 MHz to 2.7 GHzWhere (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 fieldstrength of fixed RF transmitters, as determine by an electromagnetic site survey a should be less than the compliance level in each frequency range.bIn the vicinity of devices that bear the following pictorial symbol, interference is possible:((·))
HF radiated disturbances as per IEC 61000-4-3	10 V/m80 MHz to 2.7 GHz	10 V/m

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

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 d = 1.2√P	80 MHz to 800 MHz d = 1.2√P	800 MHz to 2.7 GHz d = 2.3√P
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
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.

12. CE-markering en Conformiteitverklaring