seca 384 and 385 Instruction manual and guarantee Oct 2009

Full certification seca products you are purchasing not only technology matured over a century, but also quality confirmed by authorities, the legal system and by institutes. seca products comply with European directives, standards and national laws. With seca, you are buying the future. The products in these operating instructions comply with German legislation governing medical products and therefore with Directive 93/42/EEC of the Council of the European Community which is embodied in national laws throughout Europe.

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Scales carrying this symbol are approved for medical purposes in the European Community. seca scales with this symbol meet the stringent quality and technical requirements placed on scales which can be calibrated. Scales carrying this symbol are calibrated in accordance with Precision Class III of EC Directive 2009/23/EC. Products carrying this symbol comply with the following directives and standards: 1. Directive 2009/23/EC governing non-automatic weighing instruments 2. Directive 93/42/EEC governing medical devices 3. DIN EN 45501 governing metrological aspects of non-automatic scales

ISO 9001

ISO 13485

seca’s professionalism has also been officially recognized. The certificate from TÜV Product Service, the body responsible for medical devices, confirms that as a manufacturer of medical devices, seca rigorously complies with stringent legal requirements. seca's quality assurance system covers the design, development, production, sales and service of medical scales and measuring systems. seca helps the environment. We are concerned to save natural resources. We therefore strive to save pakkaging material where meaningful. What is left over can conveniently be disposed of locally via the German Dual System (recycling programme).

Model 384/385

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1. Congratulations! English

In the seca 384/385 electronic baby scale you have acquired a highly-accurate yet simultaneously sturdy piece of equipment. seca has been putting its experience at the service of health for over 150 years now, and as market leader in many countries of the world, is always setting new standards with its innovative developments for weighing and measuring.

The seca 384/385 electronic baby scale is designed for use in a doctor’s surgery or hospital. It serves both to establish birth weight and to check weight gain during the growth process. The scale has Class III approval.

2. Safety • Follow the instructions in the instructions for use. • Keep the operating instructions and the declaration of conformity in a safe place. • Never leave a baby lying on the scale unsupervised. • Ensure that the scale is standing firmly on a smooth, level surface.

• Do not drop the scale or subject it to violent shocks. • Use only the type of battery stated (see “Power supply” on page 14). • Have scale serviced and re-calibrated on a regular basis (see “Servicing/recalibration” on page 19). • Have repairs carried out only by authorised persons.

3. Before you start… Power supply The scale is powered by batteries. The LC display has a low power consumption – approx. 10,000 weighing operations can be performed with one set of batteries. If or bAtt appear in the display, you should change the batteries. You need 6 1.5 V type AA R6 round-cell batteries. – Take off the tray and then turn the scale over carefully so that the base is accessible (see “Setting up the scale” on page 15).

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– Open the battery compartment lid and insert the batteries supplied according to the polarity shown on the battery compartment. Check that polarity is correct! – Now close the battery compartment cover again carefully.

Setting up the scale – Place the scale on a level and stable surface. Then position the tray as shown on the base of the scale and pull forward until the tray is heard to snap into place, and the release button is in the top position. The tray is now securely interlocked with the base. – Align the scale by undoing the foot screws. The air bubble in the spirit level must be right in the centre of the circle. – Ensure that only the feet of the scale are in contact with the floor. The scale may not be in contact at any other point.

spirit level – To remove the tray just press the release button hard and slide back the tray. Important! The alignment of the base of the scale must be checked and corrected if necessary every time the location of the scale is changed.

Model 384/385

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4. Operation Correct weighing – Press the Start key with no load on the scale. SE(A, 88888 and 0.000 appear consecutively in the display. The scale is then automatically set to zero and ready for use. – When weighing infants: Place the infant on the tray, ensuring that the child lies as still as possible. Important! The maximum additional weight is 10 kg (model 384) / 20 kg (model 385) in weighing range 1 and 20 kg (model 384) / 50 kg (model 385) in weighing range 2. The maximum weight which can be displayed is reduced by the weight of the objects already placed on the scale. – When weighing children able to stand up: Remove the tray as described (see “Setting up the scale” on page 15). Note: Check the secure positioning of the base. Place the child on the scale and make sure he/she keeps still. – Read the weighing result off the digital display. Note: The scale must not be subjected to weights exceeding the maximum load specified! – To switch off the scale, press the Start key again.

Automatic switch-off/economy mode The scale remains ready for weighing for approx. 20 seconds after being switched on. Once weighing has been performed, the value is displayed for approx. 2 minutes until the scale switches off automatically.

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Taring weight display (TARE) The tare function is useful if an additional weight (such as cloths or a pad on the weighing surface) are to be ignored in the weighing result. Proceed as follows: – Place the additional weight on the scale and activate the Tare function by depressing and holding the HOLD/TARE key. The display of the scale is now reset to “0” and a normal weighing operation can begin. – You can now perform as many weighing operations as you like with this additional weight. – TARA is deactivated by pressing the button HOLD/TARE once again, or by switching the scales off.

Storing the weight value (HOLD) You can also continue displaying the weight determined once the load has been removed. This makes it possible to put the baby down safely again before noting the weight: – Press the HOLD/TARE key whilst the load is on the scale. The display flashes until a stable weight has been measured. The display is then frozen. The value remains saved in the display until the scale switches off automatically. – The HOLD function can be switched off by pressing the HOLD/TARE key again. 0.0 appears in the display if the scale has no load on it, otherwise the current weight. The “HOLD“ display vanishes. Note: The HOLD function can also be used if the TARE function has been executed beforehand.

Model 384/385

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Use of differential display function You can use this function for example to measure the intake of milk when breastfeeding or have Baby's increase in weight displayed since being last weighed. This function (which cannot be calibrated) can be used to store an individual weight value and then use that value to form a difference - to detect the amount of milk ingested during breastfeeding, for example, or to see how a particular baby’s weight has increased since it was last weighed. – To store the weight value, press the STORE key for approx. 2 seconds after the weighing operation is complete. The ST0 indicator is faded in. The weight value is now saved and will also remain stored once the scale is switched off. – With a subsequent weighing operation it is then possible to switch the display over to differential display, i.e. display of current value less saved value, by briefly pressing the STORE button. When the differential display function is activated, appears in the display.

– Briefly pressing the key again switches the function off again.

Note: If a new weight value is stored, the previous stored value will be overwritten. If the differential display function is activated with no load on the scale, the stored value is shown in the display as a negative value.

Switching the weighing range The seca 384/385 has two weighing ranges which can be selected. Weighing range 1 has a reduced maximum capacity but greater display resolution, whilst weighing range 2 allows you to use the maximum load capacity of the scale. Depending on the application in question, you decide whether you would prefer to use the fine display resolution or the high load range. – Switch on the scale at the green Start key. The scale initially operates in the weighing range last selected. – To change the weighing range, press the key

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– The symbol –>I1I<– or –>I2I<– in the display indicates the weight range which is active in each case. This remains active even when the scale is turned off.

Note: It is possible to switch from Range 1 with fine graduations to Range 2 with coarse graduations with a load on the scale unless the scale is switched to a special function (like preTare, for example). For technical reasons, it is only possible to switch from coarse Range 2 to fine Range 1 with no load on the scale. In this case too, no special function may be activated.

5. Cleaning Clean the tray and the outside of the scale with a damp cloth as required. Under no circumstances use abrasive or acid cleaners, white spirit, benzene or the like for cleaning.

6. What do I do if… … no weight is displayed with a load on the scale? – Check that the batteries are inserted correctly. … the display shows ? – Battery voltage is dropping. Charge the rechargeable batteries in the next few days. … bAtt appears in the display? – The rechargeable battery is so severely discharged that weighing is no longer possible. Recharge the battery. … St0p appears in the display? – Maximum load has been exceeded. Remove the weight on the scale as quickly as possible in order to avoid permanent damage to the scale.

7. Servicing/recalibration Have the scale recalibrated by authorised persons in accordance with national legal requirements. The year of initial calibration can be found behind the CE symbol on the rating plate above the number of the appointed office, 0109 (Hessen Weights & Measures Office). Recalibration is essential if one or more security marks are damaged. We recommend having your scale serviced by your local service agent before having it recalibrated. seca Customer Service will be pleased to give you further assistance.

Model 384/385

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8. Technical data Dimensions length: width: height: Weight Temperature range EN 60 601-1: medical electrical equipment type B: Calibration as per Directive 2009/23/EC Medical product as per Directive 93/42/EEC Height of figures Power supply Power consumption seca 384: Maximum load Weighing range 1 Weighing range 2 Graduations Weighing range 1: Weighing range 2: Accuracy at first calibration Weighing range 1: 0.2 kg up to 5 kg: 5 kg up to 10 kg: Weighing range 2: 0.4 kg up to 10 kg: 10 kg up to 20 kg: seca 385: Maximum load Weighing range 1 Weighing range 2 Graduations Weighing range 1: Weighing range 2: Accuracy at first calibration Weighing range 1: 0.4 kg up to 10 kg: 10 kg up to 20 kg:

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362 mm 550 mm 165 mm approx. 2.5 kg +10 °C to +40 °C

approved for medical use, Class III Class I 22 mm Battery approx. 30 mA

10 kg 20 kg 10 g 20 g

±5 g ±10 g ±10 g ±20 g

20 kg 50 kg 20 g 50 g

±10 g ±20 g

Weighing range 2: 1 kg up to 25 kg: 25 kg up to 50 kg:

±25 g ±50 g

9. Disposal Disposing of the device

Batteries

Do not dispose of the device in domestic waste. The device must be disposed of properly as electronic waste. Follow the national regulations which apply in your case. For further information, contact our service department at: service@seca.com

Do not throw used batteries away in domestic waste. Dispose of batteries at collection points in the vicinity. When buying new batteries, select those low in harmful substances and containing no mercury (Hg), cadmium (Cd) or lead (Pb).

10. Warranty A two-year warranty from date of delivery applies to defects attributable to poor materials or workmanship. All moveable parts - batteries, cables, mains units, rechargeable batteries etc. - are excluded. Defects which come under warranty will be made good for the customer at no charge on production of the receipt. No further claims can be entertained. The costs of transport in both directions will be borne by the customer should the equipment be located anywhere other than the customer’s premises. In the event of transport damage, claims under warranty can be

Model 384/385

honoured only if the complete original packaging was used for any transport and the scale secured and attached in that packaging just as it was when originally packed. All the packaging should therefore be retained. A claim under warranty will not be honoured if the equipment is opened by persons not expressly authorised by seca to do so. We would ask our customers abroad to contact their local sales agent in the event of a warranty matter.

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