Electronic Platform and Handrail Scales M301020-01 Rev005-UM-e Instructions for Use March 2021

Content

Introduction ... 3 Assembly ... 3 Attachment of the indicator... 3 Power supply ... 3 Replacing the rechargeable battery ... 4 Tips for handling the batteries ... 4 Quality features ... 4 Display ... 5 Description ... 5 Safety ... 6 Safety instructions ... 6 Connecting additional devices ... 6 Housing and connections ... 7 Modes ... 7 Settings ... 7 Setting date and time ... 8 Operation ... 8 Weighing ... 8 Resetting the scales back to zero ... 8 Tare function ... 8 Hold function ... 9 Determining the Body Mass Index (BMI) ... 9 Evaluating Body Mass Index ... 9 Print out a record ... 10 Care, servicing and recalibration ... 10 Cleaning ... 10 Error messages ... 10 Waste disposal ... 11 Storage and transport conditions ... 11 Warranty ... 11 Recalibration ... 11 Technical specifications ... 12 Conformity declaration ... 13 Dealer: ... 16

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Introduction

This symbol means: "Consult operating instructions". To achieve accurate results, read the instructions for use carefully before use and follow all instructions provided therein. Keep the instructions for use for future reference. Your ADE electronic scale is a quality, sturdy and durable product manufactured under the high standards and regulations for calibrated class III scales in accordance with national regulation in Germany. The scale is designed and manufactured for the daily practice in hospitals, doctors’ surgeries and in-patient nursing facilities. The scale is especially being designed for the use of adipose patients. ADE instruction manuals have been prepared to provide the user with all the necessary knowledge about the safe use of ADE scales and their related accessory equipment. For further questions about how to use the products or about this or other service manuals, feel free to contact your local ADE representative or visit our web page at www.ade-hamburg.de

Assembly The indicator/ display of your ADE scale is able to be mounted on walls, on sockets, handrails or on stand-on devices for the table depending on the model you have selected. Please insure that your scale is being placed vibration free of any vibration and at a dry place. Please take the indicator and the cable extension out of the packaging and follow the instruction for assembly. Attachment of the indicator The ADE scales are delivered in a largely assembled state. Only model M301020 requires the indicator to be connected to the weighing platform. Connect the indicator to the scale platform using the connector provided. Alignment of the scale Place the scale on a plain, dry and level surface. Adjust the scales so that all feet are in contact with the surface. The air bubble in the spirit level should be right in the centre of the circle If the scale has been transported or stored, it must be re-adjusted as described above.

Power supply Power is supplied either by the rechargeable battery in the display unit or by the mains power via the supplied power unit. The imprinted voltage value at the mains adapter must match the local mains voltage. After checking same connect the mains cable to the indicator and to a socket. Note: The wall socket must be located near to the unit and be easily accessible. Please use only the mains adapter supplied by ADE. The mains adapter is charging the battery pack at the same time. When the battery is being charged for the first time a sufficient charging period of approx. 24 hours is necessary to achieve a full battery load. In case the scale is being used with batteries only and the display indicates – Lo, the battery should be recharged with the ADE mains adapter. After the first charging period the battery need 12-16 hours. The battery should be charged while the scale is switched off. Upon completion of the charging period switch the scale on again to check the battery status. In case Lo- still appears on the display inform your service partner.

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Replacing the rechargeable battery The battery compartment is located on the front of the unit. 1) Open the battery compartment. 2) Remove the battery cables carefully from the housing, connect the wires (red to red, black to black) and insert the battery into the housing. 3) Close the battery compartment again. Only use original rechargeable batteries and charger units from ADE. The warranty does not cover any damage caused by using other types of batteries or charger units.

Tips for handling the batteries The life of a battery depends essentially on the load, frequency of use, temperatures, settings and the accessories used. –

New batteries or batteries that have been stored for long periods require a longer charging period.

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Charge the batteries at room temperature.

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Store the batteries empty (uncharged) in a cool, dark and dry place.

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Never expose the batteries to temperatures below -10°C (14°F) or above 45°C (113°F).

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Over the course of time, batteries lose their charging capacity and require a recharging period. If the battery performance drops considerably, then it is time to replace the battery.

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New batteries are supplied only partially charged. Some batteries only achieve their full capacity after several complete charge and discharge cycles.

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When disposing of disused batteries, observe the valid legal and municipal regulations. Never dispose of batteries in fire as they can leak or explode!

Quality features ADE products correspond to the applicable EC Directives and European standards to manufacture and distribute world-wide medical devices as per the latest technical standards ensuring a long life time and continuous reliability. This symbol stands for compliance of the European Directive covering medical devices and declares the conformity as per the Medical Device Law..

Approved scales classes III respecting the standards of the European guideline covering approved scales are carrying this sign.

M21

Scales carrying this symbol are approved and accredited within the European Community and fulfils first class demands for calibrated scales. Products carrying this symbol meet the requirements as per:  The valid EC Directive for non automatic scales in the latest version.

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Display Description The ADE-display (MAK) is a digital precision display unit for medical use in hospitals by doctors and specialists of all medical fields. The unit in particular features easy operation, high efficiency and long-lasting operation (over 200 hours in power save mode). 2

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Fig. 1-1 Indicator and operating controls

No. Name

Description

1 2 3

LCD display for weight, mode, settings and configuration information. Status indicator for the current battery charge level. In program mode: Status indicator for switching points 1 & 2.

4 5 6 7 8 9 10 11 12

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14 15

Display Battery charge level Switching points 1 & 2 BMI status indicator (HI, OK, LO)

Status indicator of the automatic BMI (Body Mass Index) evaluation.

LCD on - net weight is being displayed. LCD off – gross weight is being displayed. LCD on - the weight is within ¼ of a calibrated value from the zero point. Status indicator LCD off - the weight is outside ¼ of a calibrated value from the zero point. Hold – button Activates the hold function. On/off, zero – button Switch the scale on and off or re-sets the display. Tare- button Activate/ deactivate the tare function. Short push on the button to recover the stored tare value. Preset tare – button Long push on the button to enter and save the tare value. Enter to proceed with BMI mode and to enter as next step the height. BMI – Button Press again to return to weight mode. Switch button between primary and secondary units. Not available for CE Units – Button approved class III scales Figures 0-9, Clear, Enter. - Navigation functions: Key 6 menu direction to the RIGHT Key 4 menu direction to the LEFT Key 8 menu direction DOWN Number pad Key 2 menu direction UP The blue symbols under the keys (up, down, left, and right) describe the key functions in configuration and setting modes. These keys are used to navigate through the menus, to select numerical values and to increase or lower the values. Special function: In weight mode, you can change between gross and net weight using figure "0" (if any weight have been tared off). "0" key "Enter" key Function in weight mode: "Print" if printer has been connected. The scale is at a standstill, meaning the weight is stable and no Standstill status indica- movement is on the platform. This is a mandatory precondition for functor (14) : tions such as resetting, printing and taring). If the LCD is not displayed: The scale is not in a the standstill mode If displayed is the hold function is activated “Hold” Net status indicator

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No. Name

Description

16 17 18

If displayed is the weight is displayed in pounds If displayed is the weight is displayed in ounces If displayed is the weight is displayed in kilograms If displayed is the weight is displayed in grams

“Ib” “oz” “kg” “g”

Safety Safety instructions The ADE-display unit (MAK) corresponds to the latest state of the art technology and complies with standard regulations and directives. Kindly follow the safety instructions in this operating manual, the country-specific installation standards as well as the applicable safety conditions and accident prevention regulations in all aspects. Portable and mobile HF-communication systems may influence electronic medical devices. Electronic medical devices are restricted to special safety regulations in respect of their electromagnetic compatibility. For positioning and operation follow the instructions of this Operating Manual. – Before commissioning, ascertain whether the mains voltage and power type stated on the type plate match the mains voltage and power type at the place of use. –

Make sure that the mains cable does not pose any potential trip hazard.

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Only use approved accessories and peripheral equipment.

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Only operate the unit under permitted ambient conditions.

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Remove the mains plug before cleaning the unit.

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Do not operate the unit in hazardous or unstable conditions.

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Do not submerge the unit in water or other liquids.

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All actions/operations described in this operating manual may only be carried out by trained and by ADE authorised professional personnel.

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Using accessories that do not meet the safety requirements of this unit can lead to a reduction in the safety level of the entire system.

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Set up the unit as far away as possible from equipment that generates electromagnetic or other interference.

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Only ADE power adapters are allowed to use to avoid any risk of fire and electric shock.

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Clean with a dry cloth; do not use any sharp cleaning materials.

Hazard-free operation is no longer guaranteed -

If the power unit exhibits visible damage.

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If the power unit is no longer working.

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After longer periods of storage in damp rooms.

Inform your service partner in such cases for your own safety. Connecting additional devices Connection of printer, PC or remote-display will be done with the RS-232 interface. For connection of additional devices kindly ask your local representative or authorized ADE dealer for further instructions.

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Housing and connections The mains adapter connection, serial port connection and connection to the weighing cell are located on the back of the ADE indicator housing. The set-up switch to start configuration mode is recessed underneath the housing. It is protected by a cover plate and secured by a screw (not shown in Fig. 2-1). Do not use the set-up button as otherwise calibration will be lost. This procedure is only allowed to be done by authorized service personnel appointed by ADE (GmbH & Co.). Any unauthorized manipulations made to the configuration mode will affect the warranty agreement.

Modes The ADE display unit has four modes:  Weighing mode The "weighing mode" is of course the standard mode of your scale. After initial configuration and sealing (by attaching a calibration sticker to the back of the unit), the ADE-scale can only be operated in this mode.  Setting mode Date, time and consecutive numbers for print commands are being set in this mode. To start setting mode, hold the GROSS/NET key pressed until TIME appears on the display.  Configuration mode (set-up mode) The values for different parameters including the calibration could be set in the configuration mode. This function is reserved for authorized service personnel only.  Test mode There are different diagnostic functions for the ADE-MAK in test mode. This is reserved for service personnel only. Manipulations to test and configuration modes can revoke the calibration status and will result in loss of warranty!

Settings The following functions are available in setting mode: –

Select the serial interface,

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Set date, time and consecutive printout numbers.

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Set print format.

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Set switching points.

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Test functions

The setting mode is not designed for the input of metrological parameters. Access the function menu by pressing the CLEAR (13) key until TIME appears on the display. Use the key pad (13) to navigate within the menus, to select numerical values and to increase or lower the values. Press the ENTER key to save the values entered and to return to the super ordinate menu level.

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Menus structure of setting mode: FILTER

SERIAL

PROGR

PFORMT

SETPTS

TEST

TIME

DATE

VERS

Setting date and time –

Enter the CLEAR key for approx. 4 sec; FILTER appears on the display.

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Press key "6" six timed and TIME appears on the display.

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Press ENTER key and SHOW appears on the display.

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Press key "6" one time and HOUR appears on the display.

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Press ENTER key and set the hours using the arrow keys "2", "4", "6" and "8".

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Press the ENTER key and set the minutes and seconds.

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Go back by pressing key "2"; TIME appears on the display.

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Press key "6" one time and DATE appears on the display like the time entry.

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Press key "2" two times and EXIT Y appears on the display.

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Confirm with ENTER; date and time are set. Operation

Weighing Press the ON key for at least 3 seconds to turn the scales on. An automatic function test is carried out after being switched on. This test is completed when the display shows zero. The scale is now ready to be loaded. The weighing results can be read directly after a period of standstill at the display.

Resetting the scales back to zero Wait until the standstill status indicator (14) appears. By pressing the ZERO key (8), measuring inaccuracies after switching on the scale are being compensated. The zero key restarts the scale. The status indicator (6) appears when the scale is being resetted.

Tare function The TARE key (9) is used when the patient is being weighed with other items (e.g. clothing, shoes or other items) which have to be ignored by the scale. To do this, weigh these items first. After the weight is displayed, press the TARE key (9) to reset the display back to zero. The ADE-MAK changes to net mode (NET status indicator (5) is on). The weight of the previously weighed and saved items is ignored when the patients’ weight is displayed. Enter the tare button again to get back to the normal weighing mode and remove any load from the platform. Entering manually tare - values: Enter the appropriate tare value just by using the key pad under normal weighing mode. If the tare value has been entered correctly, the value will be stored. Press the ENTER key (or TARE). The ADE-display is now ready for weighing and changes to net mode [NET status indicator (5) is on]. Enter the tare button again to leave this mode. The manual tare value must be >0, the maximum value is limited by the weighing range. PRESET TARA : Press and hold the PRESET TARE key (10) [approx. 3 sec.], PRO PT X appears on the display. Select the memory location (e.g. 2). Now enter the TARE VALUE which you would like to be tared off and confirm same with ENTER. Enter the tare button again to leave this mode.

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Restore the preset PRESET TARA value: Press the PRESET TARE key (10). "Pt x" appears on the display. Enter a number from 0-9 (memory location for the tare value). If no number is entered within five seconds, the unit will turn back to weighing mode. After entering the number, the ADE-MAK accesses the preset tare value, shows it for five seconds on the display and then changes to net mode. The accessed tare value is accepted at the same time. Enter the tare button again to leave this mode. Displaying the gross weight, net weight and tare value: Press the "0" key to change between displays for tare, gross weight (NET status indicator (5) off) and net weight (NET status indicator (5) on). If a tare value is saved, the net weight shown corresponds to the gross weight minus the tare value. If there is no tare value saved, the display remains in gross mode. The tare value flashes briefly, then after a second the display changes to gross mode.

Hold function Use the HOLD key to hold the display if there are weight fluctuations which e.g. are caused by patient movements on the scales. You could also use this function if you like to hold the results at the display after the weight/load has been removed from the scale. To do this, the scales must be at standstill, e.g. the standstill status indicator (14) is on (depending on the setting it is not always necessary for the scales to be at standstill). The Hold status indicator (15) is on. Deactivate the HOLD function by pressing the key again.

Determining the Body Mass Index (BMI) The BMI figure is a index which displays the ratio between height and weight. body weight BMI= (height)² To determine this value you need the height of the person. Best way to get the height is of course to use an ADE height measuring rod; model MZ10023. Start the scale and weigh the person. Then press the BMI key (11) to start BMI mode. The last value entered appears on the display. Use the numerical key pad to enter a new value for the height (in cm) or retain the value which is already displayed. Confirm the value entered with the ENTER key or delete same by using the CLEAR key. After the entry has been confirmed by the ENTER key, the BMI value will be calculated using the weight on the scales. The display changes between weight value and BMI value "b xx.x" (every two seconds) for a period of 3 minutes. Press the BMI key (11) to cancel befoe this time has expired.

Evaluating Body Mass Index BMI evaluation according to WHO BMI 16 17

< -

16 17 18.5

Severely underweight Moderately underweight Slightly underweight

BMI

18.5

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25

Normal weight

BMI

25 30 35

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30 35 40 40

Overweight Obese Class I Obese Class II Obese Class III

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Print out a record The scales must be at standstill, e.g. standstill status display (14) appears at the screen. Press the ENTER key (13) to send the data to the serial interface. Note: Printing is not possible if the net weight is 0. The print function only produces one print-out. A reset is required to print out another copy.

Care, servicing and recalibration Cleaning Please disconnect the unit from the operating voltage before cleaning. Do not use any aggressive cleaning materials for cleaning; only use a damp cloth or conventional disinfectant. Make sure that no liquids penetrate the unit!

Error messages Error message

AD LOW AD HI EE SUM EE WR PM SUM HOFSET LOFSET UOFSET

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Description

Problem solution

Overload display

Weight exceeds max. capacity of the scales.

Overflow indicator (negative)

Negative weight indicated – weight too low to be displayed (<=99999).

Overflow indicator (positive)

Positive weight indicated – weight too high to be displayed (>=999999).

A/D above negative range

Check if the scales are correctly assembled or if they are damaged.

A/D above positive range

Check if the scales are correctly assembled or if they are damaged.

Parameter or calibration error

Recalibrate – please contact your supplier or service partner:

EEPROM indicates an error

Please contact your supplier or service partner.

Internal program indicates a check error

Please contact your supplier or service partner.

Switch on – above zero

Please remove the weight from the scales and restart.

Switch on – below zero

Check scales for damage and inform your service partner:

Irregular

Do not touch the scales after they have been switched on.

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Waste disposal Used electrical equipment and batteries do not belong in the domestic waste. Please dispose of defective or used equipment and batteries according to legal regulations of your specific country! Please make sure that only discharged batteries or batteries with insulated "poles" are disposed of as otherwise they may short-circuit!

Storage and transport conditions Keep all packaging in case you need to return the item, in order to avoid any potential transport damage. Disconnect all connected cables before dispatch. This is how you can avoid unnecessary damage.

Warranty A two-year warranty from date of delivery applies to defects attributable to poor materials or workmanship. All movable parts, e.g. batteries, cables, power units, etc. are excluded. This warranty does not cover any normal, external appearance of use and wear or any damage occurring as a result of an accident or misuse. Any warranty or damage compensation claims presuppose the use of original ADE accessories and replacement parts. The warranty does not cover units that have been opened by unauthorised persons. The legally regulated rights of the customer are in no way affected by this agreement. The supplier who sold the scales is in charge of complaints, customer service and replacement parts.

Recalibration Have the calibration carried out by an authorised company or authorised person according to national legislative regulations. The CE symbol shows the authorised site (0122) and the year of initial calibration. Recalibration must be carried out -

if the calibration mark has been damaged

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after calibrated scales have been successfully repaired

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or after expiry of a period for recalibration as stipulated by national, legal regulations.

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Technical specifications Power supply Mains Adapter: Mains voltage Frequency Power Consumption Main power circuit Input Voltage Max. Current (in-charger) Battery Requirement:

115 or 230VAC 50 or 60HZ 11W in-charger, 2W off-charger 5.0VDC 1000mA Rechargeable Lithium Ion Cylindrical (18650x2) Cell 3.7V 4000mAH

Battery Operation: Charger Saving (350ohm, Backlight-ON 30Sec, Shutdown 5Min)

7~10 Hours 200Hours

Serial Communications EDP Port Printer Port Both Ports

Full duplex RS-232 38400,19200,9600, 4800, 2400, 1200 bps Output-only RS-232 or active 20 mA current loop, 9600, 4800, 2400, 1200 bps 7 or 8 data bits; even, odd, or no parity

Operator Interface Display LCD annunciator Keyboard

6-digit LCD display. 7-segment, 0.815 in (21.2 mm) digits net, center of zero, standstill, kg/lb/g/oz/ units, Battery, Set points, Hold, HI/OK/LO 24-key flat membrane panel

Environmental Operating Temperature Storage Temperature Humidity Altitude

–10 to +40°C (legal); –25 to +70°C 0–95% relative humidity 2000 m (6500 ft) maximum

Housing Dimensions Weight Material

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18.6 cm x 9.5 cm x 10 cm 0.4 kg (without battery) ABS plastic, white

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Conformity declaration

Declaration of conformity by the manufacturer This product has been manufactured in accordance with the harmonised European standards. They conform to the regulations of the EC-directives listed below:  NAWI Directive 2014/31/EC  Medical Devices Directive 93/42/EEC  EMC Directive 2014/30/EC regarding electromagnetic compatibility  Low Voltage Directive 2014/35/EC  RoHS Directive 2011/65/EC in the currently valid versions. This declaration loses its validity if modifications are made to the scale without our approval. Hamburg, March 2021 ADE Germany GmbH Neuer Hoeltigbaum 15 22143 Hamburg / Germany

Manufacturer:

ADE Germany GmbH Neuer Hoeltigbaum 15 22143 Hamburg / Germany ℡ +49 40 432 776-0 +49 40 432 776-10  [email protected]

Notified body:

TÜV NORD CERT GmbH NB 0044 (93/42/EEC) Langemarckstraße 20 D - 45141 Essen ℡ +49 201 825-0 +49 201 825-2517  [email protected]

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Dealer:

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