UK 3047

Issue date: Valid until:

04 September 2018 24 November 2026

Grégory Glas Lead Technical Manager For and on behalf of the Head of Technical Services

0135 NMO I Stanton Avenue I Teddington I TW11 OJZ I United Kingdom

Tel +44 (0) 20 8943 7272 I Fax +44 (0) 20 8943 7270 I Web www.gov.uk/government/organisations/office-for-product-safety-and-standards NMO is part of the Office for Product Safety and Standards within the Department for Business, Energy & Industrial Strategy

EU-type examination certificate UK 3047 Revision 2

Issued by:

NMO Notified Body Number 0126

In accordance with the requirements of the Non-automatic Weighing Instruments Regulations 2016 (S.I. 2016 No. 1152) which implement, in the United Kingdom Council Directive 2014/31/EU, this EU-type examination certificate has been issued to:

Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany

In respect of a Class III, non-automatic weighing instrument designated the Babyleo TN500 and having the following characteristics:

Max 10 kg 10 kg

Min 200 g 200 g

e = 5 g 10 g

T ≤ - 3 kg - 5 kg

The necessary data (principal characteristics, alterations, securing, functioning etc) for identification purposes and conditions (when applicable) are set out in the descriptive annex to this certificate.

This revision replaces previous versions of the certificate.

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Descriptive Annex

1 INTRODUCTION

The Drägerwerk Babyleo TN500 is a Class III, mains operated, self-indicating, non-automatic weighing instrument designed for medical use as a baby weigher and incubator / warming bed (Figure 1).

The instrument shall not be used for direct sales to the public. 2 DESCRIPTION

2.1 Construction

2.1.1 Main features

− Galvanised steel supporting frame on wheels, with height adjustable support

structure

− Plastic bassinet frame with canopy, mounted on the support structure

− Radiating heat lamp fixed above the canopy

− Plastic weighing platform comprising four load cells, analogue to digital

converter, and microcontroller to process the digital weight signal (scaling).

− User interface comprising a touch-screen display and push/rotate knob

(Figure 2).

− Plastic mattress tray on the weighing platform

− Softbed mattress or heated mattress on the mattress tray

− Ventilation fan below the weighing platform

− Pedals to adjust the height of the bassinet

− Keys on bassinet frame to adjust the longitudinal tilt and adjust the height of

the weighing platform.

2.1.2 Devices

− Tare balancing − “Weigh”, “Re Weigh” and “Adjust” functions − Gravity compensation − Data storage

2.1.3 Load cell

The instrument is fitted with four load cells, type Planar Beam, Emax = 7.5 kg, manufactured by Flintec.

2.2 Operation

The instrument does not display live weights, but indicates the result of the latest Weigh or Reweigh operation as well as the previous weight operation.

2.2.1 Weigh function (tare balancing)

To weigh the patient, the “Scale” button is pressed from the home screen to navigate to the Scale dialogue window. After selecting “Weigh patient”, a message instructs the operator to “Lift the patient off the mattress”, at least 200g must be lifted from the mattress. Once the scale is tared, a signal sounds and a message on the screen instructs the operator to “Replace the patient”, the net weight is then displayed along with the result from the previous weight capture.

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2.2.2 Reweigh function

The Reweigh function can only be used within 6 minutes of a previous weighing if the tilt or height of the weighing platform is not adjusted or moved since the previous weighing, and if the Scale dialogue window remains open. When selecting “Reweigh”, the same tare value is used as in the previous Weigh function; the net weight is displayed along with the result from the previous weigh capture.

2.2.3 Adjust weight

The weight values can be manually adjusted if this function is enabled in the System setup. After a weight is captured and displayed, a value is entered in the “Adjust weight” field and confirmed by pushing the rotary knob. The adjusted weight will be displayed along with the result from the previous weight capture, and shall be clearly labelled as an adjusted weight.

2.2.4 Over-range and under-range

If the gross or net load is less than the minimum capacity, then the weight capture is not possible and the indicator will not display any weight indication.

If the net load is more than nine divisions above the maximum capacity, then the weight capture is inhibited and the indicator displays the following overload message “Maximum weight exceeded”.

If the weight on the platform after choosing a “Weigh” operation and lifting the baby is greater than the maximum tare weight, then the weight capture is inhibited and the indicator displays the following overload message “Taring load is too high”.

2.2.5 Tilting

A bubble level indicator is fitted to the weighing platform; weighing functions should only be carried out when the platform is level and the bubble is within the black circle.

3 TECHNICAL DATA

3.1 Power supply

The instrument operates on a 100 V – 240 V, 50/60 Hz mains power supply.

3.2 Metrological characteristics

Max 10 kg

Min 200 g

e = 5 g

T ≤ - 3 kg

The temperature range for the instruments is +15 °C / +45 °C.

3.3 Software

The software is split into two main parts, held on the User Interface (product software) and the In-Bed Weighing Platform. The part held on the In-Bed Weighing Platform consists of the scale application software and the boot loader. The boot loader is executed at power on, calculates the checksum of the scale application software and starts execution if the checksum is correct.

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The product software may be designated version 1.01 or 1.02. The scale application software is designated version 3.22. Any change to calibration data or scale application software version will increment the non-resettable adjustment counter. The location of the instrument is input at installation to allow gravity compensation; any change to the geographical position information will increment the non-resettable geographical position counter. The geographical position information is held on the incubator device. The version number for the product software is displayed by navigating to System setup > System > Service (requires password) (Figure 3 - Top). The version number of the scale application software, adjustment, and geographical position counters are displayed by navigating to System setup > System > Service (requires password) > Service menu > Operating Data > Scale (Figure 3 - Bottom). 3.4 Documentation and drawings

The instrument is fully described in the technical file held at NMO.

4 PERIPHERAL DEVICES AND INTERFACES

4.1 Interfaces

The instrument may have the following interface types:

− RJ45

− USB

− Serial Port

− Temperature sensors

− Nurse call

− Audio input

− Scale input

4.2 Peripheral devices The instrument may be connected to any peripheral device that has been issued with Parts (Test) Certificate by a Notified Body responsible for Module B under Directive 2014/31/EU and bears the CE marking of conformity to the relevant directives; or A peripheral device without a Parts (Test) certificate may be connected under the following conditions:

− it bears the CE marking for conformity to the EMC Directive;

− it is not capable of transmitting any data or instruction into the weighing instrument, other than to release a printout, checking for correct data transmission or validation;

− it prints weighing results and other data as received from the weighing instrument without any modification or further processing; and

− it complies with the applicable requirements of EN45501, i.e. 4.2, 4.4, 4.6 and 4.7.

A printing device may print additional information such as date or number to identify the

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printed weighing result(s) or sets of weighing results.

5 APPROVAL CONDITIONS

This certificate is issued subject to the following conditions:

5.1 Inscriptions

5.1.1 The instrument shall bear the following inscriptions on or near the display:

− Max

− Min

− e = 5.1.2 The instrument shall bear the following inscriptions as shown in figure 4:

− CE marking

− Supplementary metrology marking

− Identification number of the notified body

− Number of the EU-type examination certificate

− Manufacturer’s name, registered trade name or registered trade mark and postal address

− Accuracy class

− Type, batch or serial number

and, when applicable:

− for instruments consisting of separate but associated units: identification mark on each unit;

− scale interval if it is different from e, in the form d = …;

− maximum additive tare effect, in the form T = + …;

− maximum subtractive tare effect if it is different from Max, in the form T = – …;

− tare interval if it is different from d, in the form dT = …;

− maximum safe load if it is different from Max, in the form Lim …;

− the special temperature limits, in the form … oC/… oC;

− ratio between load receptor and load.

The markings and inscriptions shall fulfil the requirements of Article 6, Article 16, Article 17 and Point 1 of Annex III of Directive 2014/31/EU.

6 LOCATION OF SEALS AND VERIFICATION MARKS

6.1 The data plate is secured by being of a form such that it is destroyed when removed.

6.2 All legally relevant parameters are stored/provided by the weighing platform. Access to the electronics, load cell and ADC is prevented by sealing labels shown in figure 5 covering the 6 screws that seal the weighing platform.

6.3 Verification marks, and the CE-marking, are located on the side of the weighing platform. An example verification data label is shown in figure 6.

6.4 The value of the adjustment counter described in section 3.3 must be written on a tamper-evident label on the side of the weighing platform. An example adjustment counter label is shown in figure 7.

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The value of the geographical position counter described in section 3.3 must be written on a tamper-evident label on the back of the display. An example geographical position label is shown in figure 8.

6.5 All weighing platforms are calibrated identically and geographical position is held on the incubator.

7 ALTERNATIVES

7.1 The Babyleo TN500 may have product software version 1.04, all other software information remains as described in section 3.3.

7.1.1 The metrological characteristics are as follows (see figure 9):

Max 10 kg

Min 200 g

e = 10 g

T ≤ - 5 kg

8 ILLUSTRATIONS

Figure 1 Babyleo TN500 Figure 2 User interface touchscreen Figure 3 Software information Figure 4 NAWI/OIML data label Figure 5 Sealing label Figure 6 Verification data label Figure 7 Adjustment counter label Figure 8 Geographical position label Figure 9 NAWI/OIML data label (Alternative 7.1)

CERTIFICATE HISTORY

ISSUE NO. DATE DESCRIPTION

UK 3047 25 November 2016 Type examination first issued.

UK 3047 Revision 1 18 June 2018 Added product software version numbers in 3.3.

Updated wording in 5.1.2 to reflect 2014/31/EU.

Added alternative 7.1 and added these metrological characteristics to front page.

Replaced figures 3, 7 and 8. Added Figure 9.

UK 3047 Revision 2 04 September 2018 Corrected software version “1.03” to “1.04” in Section 7.1 and Figure 3.

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Figure 1 Babyleo TN500

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Figure 2 User interface touchscreen

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Figure 3 Software information

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Figure 4 NAWI/OIML data label

Figure 5 Sealing label

Figure 6 Verification data label

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Figure 7 Adjustment counter label

Figure 8 Geographical position label

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Figure 9 NAWI/OIML data label (Alternative 7.1)

Crown copyright 2018 NMO Office for Product Safety and Standards Department for Business, Energy & Industrial Strategy This material may be freely reproduced except for sale