seca 745 and 725 Instructions for Use

English

CONTENTS English 1. Description of device... 26 1.1 Intended use... 26 1.2 Description of function... 26 1.3 User qualification... 26 2. Safety information... 27

5.1 Rendering the scale operational... 34 Releasing/locking the beam . . 34 Checking the position of the beam... 34 Balancing the beam... 35 5.2 Weighing... 36 Performing a weighing operation... 36 Taring additional weight... 37

2.1 Safety information in these instructions for use... 27 2.2 Basic safety precautions... 27 Handling the device... 27 Avoiding infections... 28 6. Hygiene treatment... 38 Avoiding injury... 28 6.1 Cleaning... 38 Avoiding damage to the 6.2 Disinfecting... 38 device... 28 6.3 Sterilisation... 38 Handling the measurement results... 29 7. Function check... 39 Handling the packaging 8. What do I do if …?... 40 material... 29 9. Servicing/subsequent 3. Overview... 30 verification... 40 3.1 Controls... 30 9.1 Information on servicing 3.2 Information on device and on (seca 725)... 40 rating plate... 31 9.2 Information on servicing and 3.3 Information on the packaging . 31 subsequent verification 4. Before you get started …... 32

(seca 745)... 41

4.1 Scope of supply... 32 4.2 Remove transport lock... 32 4.3 Put on tray... 33 4.4 Set up and align scale... 33

10. Technical data... 41

5. Operation... 34

10.1 General technical data... 41 10.2 Weighing data... 42 11. Disposal... 42 12. Warranty... 43 13. Declaration of conformity... 43

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1. DESCRIPTION OF DEVICE 1.1 Intended use The seca mechanical baby scale is mainly used in hospitals, doctors' surgeries and inpatient care facilities in accordance with national regulations. The scale is both for determining birth weight and checking weight gain during the growth process, and it supports the doctor supervising treatment in making a diagnosis or deciding on a treatment. In order to make a precise diagnosis, however, other specific examinations must be set up by the physician in addition to determination of weight and their results taken into account.

1.2 Description of function On mechanical scales, weight is determined by a load lever system. To display the weight, the user moves two sliding weights on a beam until the beam is balanced. The patient's weight can then be read off at the position of the sliding weights. Use the scale only for the purpose quoted in the section entitled “Intended use”.

1.3 User qualification The device may only be operated by healthcare professionals.

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2. SAFETY INFORMATION 2.1 Safety information in these instructions for use DANGER! Used to identify an extremely hazardous situation. If you fail to take note of this information, serious irreversible or fatal injuries will occur. WARNING! Used to identify an extremely hazardous situation. If you fail to take note of this information, serious irreversible or fatal injuries may result. CAUTION! Used to identify a hazardous situation. If you fail to take note of this information, minor to moderate injuries may result. NOTICE! Used to identify possible incorrect usage of the device. If you fail to take note of this information, you may damage the device, or the measured results may be incorrect. NOTE Includes additional information about use of the device.

2.2 Basic safety precautions Handling the device

• Please take note of the information in these instructions for use. • Keep the instructions for use in a safe place. The instructions for use are a component of the device and must be available at all times. CAUTION! Patient hazard, damage to device

• Have servicing and subsequent verification carried out regularly as described in the relevant section of this document. • Technical modifications may not be made to the device. The device does not contain any parts for servicing by the user. Only have servicing and repairs performed by an authorized

Safety information • 27

seca service partner. You can find service partners in your area at www.seca.com or by sending an e-mail to service@seca.com. • Only use original seca accessories and spare parts, otherwise seca will not grant any warranty.

Avoiding infections

WARNING! Risk of infection

– Hygienically reprocess the scale regularly as described in the respective section in this document. – Make sure that the patient has no infectious diseases. – Make sure that the patient has no open wounds or infectious skin alterations, which may come into contact with the device.

Avoiding injury

WARNING! Risk of falling

Baby scales generally stand on raised work surfaces. If the baby falls from this surface, this may result in serious irreversible or fatal injuries. – Ensure that the device is steady and level. – Route connecting cables (if present) in such a way that people cannot trip over them. – Never leave a baby unsupervised.

Avoiding damage to the device

NOTICE! Damage to device

• Make sure not to drop the device. • Do not expose the device to any impact or vibration. • Perform function controls regularly as described in the relevant section in this document. Do not operate the device if it is damaged or not working properly. • Caustic detergents may damage the surfaces. Only use a soft cloth dampened with mild soapsuds to clean the surfaces of the device. • Only use disinfectants suitable for sensitive surfaces. Suitable disinfectants are available from specialist dealers.

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Handling the measurement results

WARNING! Patient hazard

This device is no diagnostic device. It simply assists the treating physician in establishing a diagnosis. – In order to make a precise diagnosis and initiate therapeutic measures, besides determination of the weight, further targeted examinations must be set up by the physician, and their results must be considered. – The responsibility for diagnosis and treatment lies with the treating physician. NOTICE! Inconsistent measuring results

• Before you save measurement values determined using this device and use them further (e.g. in seca PC software or in a hospital information system), make sure that the measurement values are plausible. • If measurement values are transmitted to seca PC software or a hospital information system, make sure prior to further use that the measurement values are plausible and are assigned to the correct patient.

Handling the packaging material

WARNING! Risk of suffocation

Packaging material made of plastic foil (bags) is a choking hazard. – Keep packaging material out of reach of children. – In the event that the original packing material may not be available anymore, only use plastic bags with security holes in order to reduce the risk of suffocation. Use recyclable materials if possible. NOTE Keep the original packing material for future use (e.g. returning for maintenance service).

Safety information • 29

3. OVERVIEW 3.1 Controls seca 745/725:

5 6 7

1 2

8

3

9 4 10

11

No.

Control

1

Large sliding weight

2

Small sliding weight

3

Tare weight with knurled screw

4

Fine-tare screw

5

Tray

6

Locking lever

8

Pointer and counterpointer Beam with scale

9

Locking lever

7

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Function Can be moved to set the weight display roughly • Pull forward: release sliding weight • Release: lock sliding weight in position Can be moved to set the weight display accurately Can be moved to balance the beam • On initial use and before every weighing operation • To tare off an additional weight Can be adjusted to balance the beam exactly • On initial use and before every weighing operation • To tare off an additional weight Where the baby is placed • 2 pcs • For locking the tray in position on the scale housing Indicate whether the beam is balanced For reading off the weight For locking/releasing the beam • Push down: lock in position • Raise: release

English No.

Control

10

Spirit level

11

Device feet

Function Indicates whether the device is horizontal (verified models) • 4 pcs • Adjustable to align the scale accurately (verified models)

3.2 Information on device and on rating plate Text/symbol Model Ser. No.

Meaning Model number Serial number Follow instructions for use

e d T

Value in mass units used for classifying and for verifying the scale (verified models) Value in mass units indicating the difference between the values of two adjacent increments Marks the zero position of the tare weight. Visible when tare weight is moved out of zero position. Scale of verification class III as per Directive 2014/31/EU

M16 0102 0123

Device complies with EC standards and directives. • M: Conformity label according to Directive 2014/31/ EU governing non-automatic weighing instruments (verified models) • 16: (Example: 2016) Year in which the declaration of conformity was completed and the CE symbol was applied (verified model) • 0102: Notified body metrology (verified models) • 0123: Notified body medical products

3.3 Information on the packaging Protect from moisture Arrows indicate top of product. Transport and store in an upright position. Fragile Do not throw or drop.

Overview • 31

Permitted min. and max. temperature for transport and storage Permitted min. and max. moisture for transport and storage Open packaging here Packaging material can be disposed of through recycling programs

4. BEFORE YOU GET STARTED … 4.1 Scope of supply

a

b

No.

a b -

Component Scale Tray User manual, not illustrated

Qty. 1 1 1

4.2 Remove transport lock The sliding weights and the tare weight are fixed in position by a transport lock (rubber band). 

Remove the transport lock as shown in the adjacent diagram before using the scale. NOTE Keep the transport lock for subsequent transport of the scale.

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4.3 Put on tray 1. Place the tray centrally on the scale.

1.

2. Ensure that the locking levers for the tray engage in the openings in the housing. 3.

3. Push the locking levers down. The tray is attached to the housing. 2.

4.4 Set up and align scale NOTICE! Incorrect measurement due to force shunts

If the scale is set up or aligned incorrectly, weight will not be measured correctly. – Place the scale on a firm and level surface. – Do not place the scale on changing mats or towels. – Set up the scale so that it is not in contact with any walls or objects. 1. Place the scale on a firm and level surface. 2. Verified models: align the scale by turning its feet so that the air bubble is in the exact centre of the spirit level.

Spirit level

NOTE Alignment of the scale must be checked and corrected every time the location of the scale is changed.

Air bubble

Before you get started … • 33

5. OPERATION 5.1 Rendering the scale operational Releasing/locking the beam

Checking the position of the beam

The beam must be locked in position when the device is transported and when the tray is to be placed on the housing. The beam must be released before weighing. 

Push the locking lever upwards. The beam is released.



Push the locking lever downwards. The beam is locked in position.

1. Ensure that the beam is released (see previous section). 2. Ensure that there is no load on the scale. 3. Push both sliding weights to the “0” position. 4. Wait until the beam has stopped swinging. NOTICE! Incorrect measurement due to force shunt

If you touch the scale, weight will not be measured correctly. – Ensure that you do not touch the scale while the beam is swinging. 5. Check whether the beam is balanced. The pointer and counterpointer must be at exactly the same level. 6. If the pointer and the counterpointer are not at exactly the same level, balance the beam as described in the section below.

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Balancing the beam 1. Ensure that both sliding weights are in the “0” position.

2. Undo the knurled screw on the tare weight. 3. Move the tare weight to balance the beam. 4. Wait until the beam has stopped swinging. NOTICE! 3.

3.

2.

Incorrect measurement due to force shunt

If you touch the scale, weight will not be measured correctly. – Ensure that you do not touch the scale while the beam is swinging. 5. Check whether the beam is balanced. Pointer and counterpointer must be at exactly or approximately the same level. 6. Repeat Step 3 if required.

7. Fix the tare weight in position using the knurled screw. 8. Turn the fine-tare screw until the pointer and counterpointer are exactly opposite one another. The scale is operational. 7.

8.

Operation • 35

5.2 Weighing CAUTION! Risk of falling, faulty operation

To prevent falls from the scale and faulty operation, you must ensure before each use that the scale is operational. – Ensure that the tray is correctly fixed in position (see “Put on tray” on page 33). – Perform a function check (see “Function check” on page 39). – Check whether the beam is balanced (see “Checking the position of the beam” on page 34).

Performing a weighing operation

1. Ensure that the locking lever of the beam is released (see “Releasing/locking the beam” on page 34). 2. Place the baby on the tray. WARNING! Risk of falling

Baby scales generally stand on raised work surfaces. If the baby falls from this surface, this may result in serious irreversible or fatal injuries. – Ensure that the device is steady and level. – Route connecting cables (if present) in such a way that people cannot trip over them. – Never leave a baby unsupervised.

3.

3. Move the large sliding weight until the beam is balanced approximately. Pointer and counterpointer must be at approximately the same level. 4. Wait until the beam has stopped swinging. NOTICE! Incorrect measurement due to force shunt

If you touch the scale, weight will not be measured correctly. – Ensure that you do not touch the scale while the beam is swinging.

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English 5. Move the small sliding weight until the beam is balanced exactly. Pointer and counterpointer must be at exactly the same level. 5.

6. Wait until the beam has stopped swinging. NOTICE! Incorrect measurement due to force shunt

If you touch the scale, weight will not be measured correctly. – Ensure that you do not touch the scale while the beam is swinging.

3 kg

600 g Taring additional weight

7. Read off the baby's weight: – read off the kilogram number at the large sliding weight (in this case: 3 kg = 3,000 g) – read off the gram number at the small sliding weight (in this case: 600 g) – add the two values (in this case: 3,600 g)

You can use the tare weight to compensate for a maximum of 2,500 g additional weight (e.g. a towel or padding). The additional weight is not taken into account in the weighing result. NOTICE! Incorrect measurement due to force shunts

If an additional weight such as a large towel is in contact with the surface on which the scale is standing, the weight will not be measured correctly. – Make sure that any additional weights is only placed on the tray of the scale. 1. Place the additional weight on the tray. 2. Balance the beam (see the section entitled “Balancing the beam” on page 35). 3. Perform the weighing operation (see “Performing a weighing operation” on page 36).

Operation • 37

6. HYGIENE TREATMENT NOTICE! Damage to device

Inappropriate detergents and disinfectants may damage the sensitive surfaces of the device. – Do not use aggressive or abrasive cleaning agents. – Do not use white spirit or petroleum spirit. – Only use disinfectants suitable for sensitive surfaces. Suitable disinfectants are available from specialist dealers.

6.1 Cleaning 

Use a soft cloth dampened with mild soapsuds to clean the surfaces of the device.

6.2 Disinfecting 1. Check that your disinfectant is suitable for sensitive surfaces and acrylic sheet. 2. Follow the instructions on the disinfectant. 3. Disinfect the device by moistening a soft cloth in disinfectant and wiping the device over with it. 4. Please take note of the following terms: Interval

Component

Before every measurement Tray After every measurement

Tray

If required

Display elements, controls, housing

6.3 Sterilisation This device may not be sterilised.

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7. FUNCTION CHECK 

Perform a function check prior to each use.

A complete function check includes: • • • •

visual inspection for mechanical damage checking the alignment of the device visual and function check of the display elements function check of all the controls shown in the section entitled “Overview” • function check of optional accessories If you notice any faults or deviations during the function check, first try to resolve the error with the aid of the section entitled “What do I do if ...” in this document. CAUTION! Personal injury

If you notice any faults or deviations during the function check which cannot be resolved with the aid of the section entitled “What do I do if ...” in this document, you may not use the device. – Have the device repaired by seca service or by an authorized service partner. – Follow the section entitled “Servicing/ recalibration” in this document.

Function check • 39

8. WHAT DO I DO IF …? Fault ... the beam does not move when the scale is loaded?

Cause/Remedy Scale is not operational - Remove transport lock (rubber band) - Release locking lever

Scale is not correctly aligned - Align scale, see 4.4 Beam was not balanced before the weighing operation - Balancing the beam, see 5.1 Force shunt, scale is in contact with a wall or the housing is abutting something (e.g. a towel) ... the scale is not dis- Increase distance from wall playing plausible values? - Set up scale so that only the device feet are in contact with the floor Force shunt, an additional weight (e.g. towel) is in contact with the surface on which the scale is standing - Ensure that additional weights are only on the tray

9. SERVICING/SUBSEQUENT VERIFICATION 9.1 Information on servicing (seca 725) The product must be set up carefully and serviced regularly. Depending on how frequently the product is used, we recommended servicing at intervals of 3 to 5 years. NOTICE! Incorrect measurements as a result of poor servicing

– Have servicing and repairs carried out exclusively by seca service or by an authorized service partner. – You can find service partners in your area at www.seca.com or by sending an e-mail to service@seca.com.

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9.2 Information on servicing and subsequent verification (seca 745) We recommend having your device serviced prior to subsequent verification. NOTICE! Incorrect measurements as a result of poor servicing

– Please only have servicing and repairs performed by an authorized service partner. – You can find service partners in your area at www.seca.com or by sending an e-mail to service@seca.com. Have an authorized technician perform subsequent verification according to national legal regulations. Subsequent verification is necessary whenever one or more verification seals are damaged.

10.TECHNICAL DATA 10.1 General technical data General technical data seca 745/725 Dimensions • Width • Height • Depth Weight

555 mm 185 mm 320 mm approx. 6 kg

Ambient conditions, operation • Temperature • Air pressure • Humidity

+10 °C to +40 °C (50 °F to 104 °F) 700 - 1060 hPa 30 % - 80 %, no condensation

Ambient conditions, storage • Temperature • Air pressure • Humidity

-10 °C to +65 °C (14 °F to 149 °F) 700 - 1060 hPa 0 % - 95 %, no condensation

Ambient conditions, transport • Temperature • Air pressure • Humidity

-10 °C to +65 °C (14 °F to 149 °F) 700 - 1060 hPa 0 % - 95 %, no condensation

Technical data • 41

General technical data seca 745/725 Medical device in accordance with Directive 93/42/EEC

Class I with measuring function

10.2 Weighing data Weighing data seca 745 Verification according to Directive 2014/31/EU

Class III

Maximum load

16 kg

Minimum load

0.2 kg

Increments (e)

10 g

Tare range

max. 2.5 kg

Accuracy following initial verification: • to 5 kg • over 5 kg

±5 g ±10 g

Weighing data seca 725 Maximum load

16 kg

Increments (d)

5g

Tare range Accuracy • to 4 kg • 4 kg to 16 kg

max. 2.5 kg ±10 g ±0.25 %

11.DISPOSAL This device consists of high-quality raw materials which can be recycled. Dispose of the device in accordance with the local laws and regulations applicable in your country.

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12.WARRANTY We offer a two-year warranty from the date of delivery for defects attributable to faulty material or poor workmanship. This excludes all moveable parts such as (rechargeable) batteries, cables, power supply units, etc. Defects which are covered by the warranty shall be rectified free of charge for customers on production of the sales receipt. No further claims can be accepted. The costs of shipment in both directions shall be borne by the customer where the device is not located at the customer's premises. In the event of any damage during shipment warranty claims can only be asserted where the complete original packaging was used for shipment and the scales were secured inside in the same manner as in the original packaging. You should therefore keep all packaging. The warranty shall become null and void where the device is opened by persons not expressly authorised to do so by seca. We ask customers based abroad to contact their local sales agent directly in the case of warranty claims.

13.DECLARATION OF CONFORMITY seca gmbh & co. kg hereby declares that the product meets the terms of the applicable European directives. The unabridged declaration of conformity can be found at: www.seca.com.

Warranty • 43