Babyleo TN500 Information on Verification of the Scale Rev 2.0

This page has been left blank intentionally.

2

Information on verification of the scale

| Babyleo TN500

Contents

Contents Babyleo TN500 IncuWarmer

1

2

3

Use of this documentation ...

4

1.1 1.2

Subject to change without notice ... Copyright and other protected rights ...

4 4

Basic safety Information...

5

2.1 2.2 2.3

Compliance with the documentation... Symbols and product labels... Modifications to the product...

5 5 5

Information on verification of the scale ...

6

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12

6 7 8 8 8 11 13 15 16 17 17 19

General information ... Scale function ... Geographic position... Software identification... Labeling ... Turning the device on and off ... Important instructions for handling... Establishing a level position... Removing the mini wall... Establishing the top position ... Access to the service menu... Calibration procedure ...

Information on verification of the scale | Babyleo TN500

3

Use of this documentation

1

Use of this documentation This document contains information on the calibration of the scale for the IncuWarmer Babyleo TN500 from version 1.05.

1.1

Subject to change without notice Dräger reserves the right to modify the product and/or this documentation without prior notice. This documentation is intended exclusively as information for service personnel or specialized service personnel.

1.2

Copyright and other protected rights The content of this documentation, in particular the design, text, software, technical drawings, configurations, graphics, figures, data and their selection and composition and any modifications (content) are subject to copyright. The content (in full or in parts) may not be modified, copied, distributed, reproduced, republished, displayed, transmitted or sold without the written permission of Dräger.

4

Information on verification of the scale | Babyleo TN500

Basic safety Information

2

Basic safety Information

2.1

Compliance with the documentation Without exact knowledge of and compliance with this documentation, carrying out the measures described herein could lead to personal injury, damage to property, or damage to the environment. Using the product without exact knowledge of and compliance with the corresponding instructions for use could lead to personal injury, damage to property, or damage to the environment. ► Make sure that you have the current revision of this documentation. Use only the current revision of this documentation. ► Carefully read and comply with the measures described in this documentation. ► Carefully read and comply with the corresponding instructions for use.

2.2

Symbols and product labels If the symbols and product labels are not observed, personal injury, property damage or environmental damage may result. ► Observe the symbols and product labels.

2.3

Modifications to the product Modifications to the product may result in malfunctions and subsequently in personal injury (injury or death), property damage, or environmental damage. ► Do not modify the product.

Information on verification of the scale | Babyleo TN500

5

Information on verification of the scale

3

Information on verification of the scale The following document content provides some background on the Babyleo TN500 scale. The document is intended for submission to calibration agencies and officials, other official bodies, or persons as appropriate.

3.1

General information The Babyleo TN500 is a heat therapy device for premature babies and neonates. It can be used to warm patients with a body weight of up to 5 kg (11 lbs) and height of up to 55 cm (22 in). The Babyleo TN500 provides a controlled environment with heat and humidity. The device can be used as an incubator and as a radiant warmer. A non-automatic scale can be integrated into the device as an option for determining the patient’s weight. The device’s scale is approved in accordance with the requirements of the regulations of EU Directive 2014/31/EU for non-automatic weighing instruments. The certificate number is T11461. The notified body is the National Metrology Institute (NMI) in the Netherlands. The scale has the following features: Class Max Min e T Operating range of the weighing module

III 10 kg 200 g 10 g -10 kg 15 °C/+45 °C

Drägerwerk AG & Co. KGaA (Lübeck, Germany) evaluates the conformity of the scale. Pursuant to standard EN 45501:2015, the scale consists of the two weighing module and terminal components. Weighing module: Located directly under the mattress tray. When weighing, only the patient with all the objects (incl. mattress) on the mattress tray are weighed. The weighing module can be removed from the device for cleaning.

6

Information on verification of the scale | Babyleo TN500

40809

Information on verification of the scale

Fig. 1

Weighing module

Terminal: Is the remaining part of the device pursuant to EN 45501:2015. Both components are connected by a disconnectable connector and a cable. Two labels are provided for assigning the terminal and the weighing module: – Label on the weighing module: Contains the serial number of the weighing module (see Fig. 3 in chapter 3.5.2 Labeling the weighing module). – Label on the terminal: Identification of the assigned weighing module via the corresponding serial number (see Fig. 2/1 in chapter 3.5.1 Device labeling).

3.2

Scale function The weighing process starts after pressing the key and lifting the baby. Weighing is completed when the baby is placed on the mattress tray. The device does not display any current weights, only the result of the last "Weigh" or "Reweigh" weighing process. Maximum load No values are displayed if the weight exceeds the weighing range, and the following message is shown: Maximum weight exceeded. Maximum tare weight The following message appears if the maximum tare weight is exceeded: Load is too high for zeroing.

Information on verification of the scale | Babyleo TN500

7

Information on verification of the scale

3.3

Geographic position The location data of the place of application (latitude and altitude, geolocation data of the scale) is saved on the terminal and secured against accidental changes by a non-resettable change counter. The location data of the operating location and the associated change counter can be read off the scale label on the rear of the device (see Fig. 2/1 in chapter 3.5.1 Device labeling). In addition, the location data of the operating location stored in the device can be read out via the service menu (see Fig. 13/3 and chapter 3.11 Access to the service menu). When calibrating the weighing module, the location data of the calibration location (cannot be read out) is read out for the currently set place of application and saved in the weighing module together with the calibration curve. Every calibration process is secured against unauthorized changes by a non-resettable change counter (calibration counter). The counter reading of the change counter is noted on the label on the weighing module together with the calibration date. The calibration counter can also be read out in the service menu (see Fig. 13/2 in chapter 3.11 Access to the service menu). Before starting the weighing process, the geolocation data is transmitted from the terminal to the weighing module using a secured data path. The weighing modules uses the transmitted geolocation data and the stored location data of the calibration location to perform a geocorrection. The corrected weight value in grams is transmitted to the terminal via the secured data path and Weight (full resolution) [g] and Weight [g] are displayed in the service menu. The weight value Weight [g] is displayed in accordance with the scale’s metrological specification in clinical operation.

3.4

Software identification To completely identify the software, the software version of the weighing module must be considered together with the product software version. The software version of the weighing module can be read off the label on the weighing module (see the Fig. 3 circled in green in chapter 3.5.2 Labeling the weighing module). The product software version can be read off the scale label on the rear of the device (see Fig. 2/1 in chapter 3.5.1 Device labeling). The software versions can also be read out in the service menu (see Fig. 12/1 and Fig. 13/1 in chapter 3.11 Access to the service menu).

3.5

Labeling

3.5.1

Device labeling The scale label (2M60669, Fig. 2/1) with information on the scale and the device’s name plate (Fig. 2/2) are located on the rear of the device.

8

Information on verification of the scale | Babyleo TN500

40536

Information on verification of the scale

Fig. 2

3.5.2

Device labeling

Labeling the weighing module The weighing module’s name plate (2M60657) is located on the base of the module. SN stands for serial number.

40505

The label with the calibration data, the software version, and the scale identification (2M60660), and the label with the approval number (2M60659) are located on the right side of the weighing module.

Fig. 3

Labeling the weighing module

The 6 screws for opening the module are secured with seal stickers (Fig. 4).

Information on verification of the scale | Babyleo TN500

9

40507

Information on verification of the scale

Fig. 4

3.5.3

Seal stickers for the weighing module

Alternative labels The factory labeling may need to be replaced as part of a repair or software update. The contents of the alternative labels are identical to the factory labeling, but the product-specific fields are not filled. These fields are filled out on site as part of the repair. A corresponding comparison can be found in the following table.

10

Factory labeling

Repair labeling

2M60657

2M60109

2M60660

2M60684

Information on verification of the scale | Babyleo TN500

Information on verification of the scale

3.5.4

Factory labeling

Repair labeling

2M60669

2M60685

Recommendation for affixing calibration marks and security marks We recommend affixing the calibration mark near the label with the approval number. The scale label on the rear of the device (2M60669, Fig. 2/1) and the label with the calibration data (2M60660, Fig. 3) contain variable data. This data is initially printed on the label by the manufacturer as part of the assessment of conformity. In the event of subsequent changes, e.g. calibrations, the data is hand-written on a new label with empty fields. We recommend protecting these labels against unauthorized changes by using security marks during the calibration.

3.6

Turning the device on and off

3.6.1

Turning the device on NOTE The device performs an automatic self-test when it turns on. If the device detects an error, a corresponding message or alarm is displayed. Procedure: 1. Connect the power plug. 2. Turn on the main switch on the rear of the main column (I position). 3. Then turn the device on at the front on the control unit with the Start/Stand-by button (Fig. 5/1).  The device performs an automatic self-test. The main page is then displayed.

Information on verification of the scale | Babyleo TN500

11

40508

Information on verification of the scale

Fig. 5 3.6.1.1

Control unit

Turning off the device Before the device is turned off, lower the lifting column to the transfer height. Procedure: 1. Adjust the height of the device using the foot pedals. If the red hatched sticker on the lifting column is completely covered, the correct transfer height has been reached. 2. Turn the device off at the control unit with the Start/Stand-by button.  The Shut down dialog window is displayed. 3. Tap the Shut down button and confirm.  The device functions are shut down. 4. Turn off the main switch on the rear of the main column (O position). NOTE Before removing the power plug, the device must also be turned off at the main switch. If the device is only turned off with the Start/Stand-by button on the control unit, and the power plug is subsequently disconnected, an alarm signal sounds for a few minutes. 5. Pull the power plug.

12

Information on verification of the scale | Babyleo TN500

Information on verification of the scale

3.7

Important instructions for handling These instructions must be followed to ensure correct weighing: – The device with the scale has been acclimatized in the test room for at least 24 hours. – The device is in operation and the scale connected. – Before the start of calibration, the device must have been in operation for at least 10 minutes to allow the operating temperatures of the load cells and the electronics to stabilize. – For optimal access, operate the device in radiant warmer mode (with hood open) and move the mattress tray to the top position (see Fig. 11). – The radiant warmer is switched off. – The side access panels are folded down. – The device is not located within a draft (e.g., from air conditioning). – The trolley brakes are engaged. – The air bubble on the spirit level is within the black ring and does not touch the ring. – Attachments, such as supply and discharge hoses, have been removed. – Make sure that exact weighing is not impaired by wind or drafts. – When the device is raised, do not touch the mattress tray and the device. – So as not to distort the weighing result, do not use the mattress tray as support or, for example, touch the mattress tray with scrubs. – We recommend placing a setting load of 10 kg onto the mattress tray for approx. 10 s three times in succession before calibration.

Information on verification of the scale | Babyleo TN500

13

Information on verification of the scale

3.7.1

Switching to radiant warmer mode and turning off the radiant warmer 1. Open the hood.  The device automatically switches to radiant warmer mode.

41350

2. Set the therapy adjuster Warmer to Off (Fig. 6/1) and confirm with the rotary knob.

Fig. 6

14

Radiant warmer mode

Information on verification of the scale | Babyleo TN500

Information on verification of the scale

3.8

Establishing a level position

40511

1. Move the mattress tray to a level position using the two bottom buttons (Fig. 7) on the mattress tray control panel and the spirit level.

Fig. 7

Buttons for the level position

 The mattress tray stops automatically once the level position is reached.

30295

 The air bubble in the spirit level is within the black ring and does not touch the ring (Fig. 8).

Fig. 8

Pay attention to the spirit level

NOTE If necessary, unevenness in the floor need to be compensated by aligning the device by tilting the mattress tray. ✓ The level position has been established.

Information on verification of the scale | Babyleo TN500

15

Information on verification of the scale

3.9

Removing the mini wall 1. Loosen the attachment before the mini wall can be removed. 2. Hold the mini wall precisely in the center from the inside (Fig. 9/1). 3. Push the bottom edge of the mini wall outwards (away from the mattress tray). 4. As soon as the center of the mini wall is released (Fig. 9/2) tilt it inwards (towards the mattress tray).

34341

5. Remove the mini wall.

Fig. 9

3.9.1

Mini wall

Removing the mattress 1. If a heated mattress is installed in the device proceed as follows: ● Remove the cable on the rear of the sensor wall, guide it through the hose grommet in the center of the sensor wall, and remove.

27109

2. Remove the mattress from the mattress tray.

Fig. 10

16

Mattress

Information on verification of the scale | Babyleo TN500

Information on verification of the scale

3.10

Establishing the top position 1. Move the mattress tray to the top setting using the top right button (Fig. 11) on the mattress tray field.

40881

 The LED in the button is extinguished when the top setting is reached (Fig. 11).

Fig. 11

3.11

Button for the top position

Access to the service menu 1. In the main menu bar, tap the System setup... button. 2. In the System setup dialog window, open the System > Service page. 3. Enter the password 0000 and confirm.

Information on verification of the scale | Babyleo TN500

17

Information on verification of the scale

NOTE If the password does not work, another password may have been set. In this case, contact the hospital staff.

41266

 The product software version can be read out (see Fig. 12/1).

Fig. 12

Product software version

4. Tap the Service menu button and confirm with the rotary knob.  The Service dialog window is displayed. 5. In the Operating Data tab open the Scale tab.  General information displays the following data for the scale (Fig. 13/1): – Status (Scale status). – Serial number (Serial number) and software version (Software version). – High-resolution weight (Weight (full resolution) [g]) and weight in clinical operation (Weight [g]).

18

Information on verification of the scale | Babyleo TN500

Information on verification of the scale

NOTE For (Weight (full resolution) [g]) the display accuracy is 1 g. For (Weight [g]) the display accuracy is 10 g.  Scale adjustment displays the number of scale calibrations (Number of adjustments) (Fig. 13/2).  Geographical position displays the following data for the scale (Fig. 13/3): – Change counter for the geographic position (Change counter). – Latitude (Latitude [°]). 40526

– Altitude above sea level (Altitude [m]).

Fig. 13

Tab Operating Data

NOTE If necessary, the weighing function can be disabled using the Deactivate button (Fig. 13/4). Activation is only possible by specialized service personnel.

3.12

Calibration procedure Calibration can be performed in clinical operation or in the service menu. Calibration in the service menu is easier for the user and is described below.

3.12.1

Preparing the scale To be able to correctly check the measurement limits during calibration, the scale must be set to zero.

Information on verification of the scale | Babyleo TN500

19

Information on verification of the scale

Preconditions – The device with the scale has been acclimatized in the test room for at least 24 hours. – Before the start of calibration, the device must have been in operation for at least 10 minutes to allow the operating temperatures of the load cells and the electronics to stabilize. Procedure: 1. Lock the castors. 2. Remove attachments such as supply and discharge hoses. 3. Turn on the device and switch to radiant warmer mode. 4. Turn off the radiant warmer. 5. Horizontally align the mattress tray. 6. Move the mattress tray to the top position. 7. Switch to the service menu (see chapter 3.11 Access to the service menu). 8. If a heated mattress is present, disconnect the associated connector. 9. Remove the mini walls and the existing mattress from the mattress tray. 10.Place a setting load of 10 kg onto the mattress tray for approx. 10 s three times in succession. 11. Tap the O/T button. 40527

 The scale is set to zero.

Fig. 14

General information tab

NOTE The scale is fitted with a combined zeroing and taring mechanism. Negative weight values may be displayed in the service menu for the following reasons: – If a test weight is on the mattress tray when zeroing the scale and this test weight is removed after zeroing.

3.12.2

Checking the counter readings The change counter’s readings can be read out (see chapter 3.11 Access to the service menu) and compared with the entries on the labels (see chapter 3.5.1 Device labeling and 3.5.2 Labeling the weighing module).

20

Information on verification of the scale | Babyleo TN500