Baby Leo

Test instructions / Service Card IPM-L
Babyleo TN500
IncuWarmer
28227
Warning
Revision 10
All servicing and/or test procedures on the
device require detailed knowledge of this
documentation. Use of the device requires
detailed knowledge and observance of the
relevant Instructions for Use.
Babyleo TN500
Table of contents
Table of contents
Basic safety information 5

Inspection and servicing .......................................................................................................... 5
General information 6
1 Device configuration 6
1.1 Software version ...................................................................................................................... 6
1.2 Options..................................................................................................................................... 6
1.2.1 Scale.......................................................................................................................... 6
1.2.1.1 Type, software version and serial number............................................................. 7
1.2.1.2 NAWI scale (geographical position) ...................................................................... 7
1.2.1.3 NAWI scale (adjustment data)............................................................................... 8
1.2.2 Mattress ..................................................................................................................... 8
1.2.3 Drawer ....................................................................................................................... 8
1.2.4 Oxygen control .......................................................................................................... 8
1.2.5 Mount for gas cylinders ............................................................................................. 8
1.2.6 Auto Thermo package ............................................................................................... 9
1.2.7 Developmental care package .................................................................................... 9
2 Maintenance parts 9
2.1 Maintenance intervals, overview.............................................................................................. 9
2.2 Maintenance parts by specified interval................................................................................... 10
2.2.1 (Option) O2 sensors .................................................................................................. 10
2.2.2 Humidifier .................................................................................................................. 10
2.2.3 Seals for incline motors ............................................................................................. 10
2.2.4 Lithium button cell 3 V/195 mAh ................................................................................ 10
2.2.5 Fan motor .................................................................................................................. 11
2.2.6 (Option) Visual inspection of the inner compressed gas hose................................... 11
2.3 Maintenance parts as required ................................................................................................ 11
3 Electrical safety 11
3.1 Electrical safety according to IEC 62353 ................................................................................. 11
3.1.1 Visual inspection........................................................................................................ 12
3.1.2 Protective earth resistance measuring points............................................................ 12
3.1.3 Protective earth resistance ........................................................................................ 13
3.1.4 Equipment leakage current, test adapter for applied parts ........................................ 13
3.1.5 Device leakage current .............................................................................................. 13
3.1.6 Applied part leakage current, mains on applied part, type BF ................................... 15
3.1.6.1 Central skin temperature sensor (yellow).............................................................. 15
3.1.6.2 Peripheral skin temperature sensor (white)........................................................... 16
3.2 Electrical safety according to IEC 60601-1 .............................................................................. 16
3.2.1 Visual inspection........................................................................................................ 17
3.2.2 Protective earth resistance measuring points............................................................ 17
3.2.3 Protective earth resistance ........................................................................................ 17
3.2.4 Earth leakage current ................................................................................................ 18
No.2001_0000009935
3.2.5 Test adapters for patient leakage current .................................................................. 19

3.2.6 Patient leakage current.............................................................................................. 19
3.2.6.1 Central skin temperature sensor (yellow).............................................................. 20
2 / 63 Test instructions / Service Card IPM-L | Revision 10 |

Babyleo TN500
Table of contents
3.2.6.2 Peripheral skin temperature sensor (white) .......................................................... 20

4 Function and condition test 20
4.1 Condition tests ......................................................................................................................... 20
4.1.1 Accompanying documents ........................................................................................ 20
4.1.2 Product labels............................................................................................................ 20
4.1.3 Casing, complete....................................................................................................... 25
4.1.4 Hood.......................................................................................................................... 27
4.1.5 Access flaps and feedthrough openings ................................................................... 27
4.1.6 Castors ...................................................................................................................... 28
4.2 Function tests .......................................................................................................................... 28
4.2.1 Power-on test ............................................................................................................ 28
4.2.2 Height adjuster .......................................................................................................... 28
4.2.3 Operating mode......................................................................................................... 29
4.2.4 Air temperature and humidity control ........................................................................ 29
4.2.5 (Option) Adjusting (aligning) the O2 sensors............................................................. 31
4.2.6 (Option) O2 control.................................................................................................... 31
4.2.7 Skin temperature control ........................................................................................... 31
4.2.8 Sensor test (skin temperature sensors) .................................................................... 31
4.2.9 Metrological check..................................................................................................... 32
4.2.10 (Option) Standard scale up to Babyleo TN500 software 1.04 ................................... 32
4.2.11 (Option) Standard scale as of Babyleo TN500 Software 1.05................................... 34
4.2.12 (Option) NAWI scale with Babyleo TN500 software below 1.04................................ 37
4.2.12.1 Labeling................................................................................................................. 37
4.2.12.2 Test preparation .................................................................................................... 38
4.2.12.3 In-service test (service inspection)........................................................................ 40
4.2.12.4 Pre-verification test ............................................................................................... 42
4.2.13 (Option) NAWI scale with Babyleo TN500 software 1.04 .......................................... 44
4.2.13.1 Labeling................................................................................................................. 44
4.2.14 (Option) NAWI scale with Babyleo TN500 software 1.05 .......................................... 51
4.2.14.1 Labeling................................................................................................................. 51
4.2.15 Tests with the HIT software ....................................................................................... 59
4.2.15.1 Nurse Call ............................................................................................................. 60
4.2.15.2 Fan wheel.............................................................................................................. 60
4.2.15.3 O2 valve ................................................................................................................ 60
4.2.16 Power failure alarm ................................................................................................... 60
4.2.17 Final action ................................................................................................................ 61
4.2.17.1 Device handover with test label ............................................................................ 61
No.2001_0000009935
5 Test equipment 61
5.1 Test equipment subject and not subject to mandatory calibration ........................................... 61
5.1.1 Test equipment subject to mandatory calibration ...................................................... 61
| Revision 10 | Test instructions / Service Card IPM-L 3 / 63

Babyleo TN500
Table of contents
5.1.2 Test equipment not subject to mandatory calibration ................................................ 63
No.2001_0000009935

Babyleo TN500
Basic safety information
Basic safety information
Inspection and servicing
If the inspection and servicing activities are not performed correctly, this may
lead to personal injury and property damage.
► The inspection and servicing activities on the product require specific
knowledge of and compliance with this documentation and the product's
instructions for use.
► Only perform the inspection and servicing activities if no patient is located
in the device.
► Before using these test instructions, check that they are up to date
(compare the revision to the current service documentation).
No.2001_0000009935

Babyleo TN500
General information
General information
NOTE
All results and inputs must be recorded in the electronic test instructions or in
a printed outcome document.
NOTE
– These test instructions must be followed after performing a repair.
– These test instructions can be used to perform an inspection and mainte-
nance.
1 Device configuration
This chapter contains test steps to document the configuration.
NOTE
The part number and serial number of the device are recorded in the
electronic test instructions or in a printed outcome document.
1.1 Software version

Action • Subsequently read and record the software version under "Function and
condition test" (the software version can be read out in the service menu).
Result Software version [________txt]
1.2 Options
NOTE
The possible options are listed in the following. Confirm the existing option
with "OK" or enter the required parameters.
The options are also listed in the service menu under "Applications".
1.2.1 Scale
NOTE
The following scale data must be recorded and compared if necessary.
Read off the data in the service menu and/or from the product tag (label).
What is read Where Stan- NAWI

No.2001_0000009935
dard
Scale type Label on the scale X X
Software version Label on the scale Service Menu X X
Serial number Label on the scale Service Menu X X

Babyleo TN500
Device configuration
What is read Where Stan- NAWI

dard
Number of adjustments Label on the scale Service Menu X
Number of changes of Label on the rear col- Service Menu X
the geographic data umn wall
(Geographical position)
1.2.1.1 Type, software version and serial number
NOTE
Read the scale type later, when checking the product tags, and choose here
accordingly.
Result Scale type Standard scale [ ]

NAWI scale [ ]
Action • Subsequently read and record the software version under "Function and
condition test" (the software version can be read out in the service menu).
Result Software version [________txt]
Action • Compare the software version from the service menu and the label on the
scale. If the specifications of the software version are different, correct the
sticker.
Action • Subsequently read and record the serial number under "Function and
condition test" (the serial number can be read out in the service menu).
Result Serial number [________txt]
Action • Check if the serial number from the service menu matches the serial
number on the label (rear column wall).
NOTE
If the serial numbers do not match, inform the operator of the following:
– The integrated weighing module is not assigned to the Babyleo TN500.
– For NAWI scales only: The existing combination of Babyleo TN500 and
weighing module is not verified and is not verifiable.
1.2.1.2 NAWI scale (geographical position)
Action • Subsequently read and record the Change counter under "Function and
condition test" (can be read out in the service menu).
Result Change counter from the service menu [________txt]
Action • Read off and record the Change counter from the label on the rear column
wall.
Result Change counter from the label [________txt]
No.2001_0000009935
Action • Compare the Change counter from the service menu and the label.
Test The change counters coincide.

Babyleo TN500
Device configuration
NOTE
If the change counters do not coincide, inform the customer that the scale
must be calibrated. Update the labels in compliance with the national
regulations.
Result Comparing the Change counter [________OK]
1.2.1.3 NAWI scale (adjustment data)
Action • Subsequently read and record the Number of adjustments under "Function
and condition test" (can be read out in the service menu).
Result Number of adjustments from the service menu [________txt]
Action • Subsequently, when checking the product tags, read off and record the
Number of adjustments from the label on the scale.
Result Number of adjustments from the label [________txt]
Action • Compare the Number of adjustments from the service menu and the label.
Test The number of adjustments coincides.
NOTE
If the number of adjustments does not coincide, inform the customer that the
scale must be calibrated. Update the labels in compliance with the national
regulations.
Result Comparing the Number of adjustments [________OK]
1.2.2 Mattress
NOTE
Heated, X-ray transparent mattress
Result "Heated mattress" option [________OK]
1.2.3 Drawer
Result "Drawer" option [________OK]
1.2.4 Oxygen control

Result "Oxygen control in the patient room" option [________OK]
1.2.5 Mount for gas cylinders

Result "Mount for gas cylinders (max. 2 units)" option [________OK]
No.2001_0000009935

Babyleo TN500
Maintenance parts
1.2.6 Auto Thermo package
NOTE
AutoThermo package for advanced treatment applications
– Leave to cool
– Heat
– Wean
Result "AutoThermo package for additional treatment applications" option [________OK]
1.2.7 Developmental care package
NOTE
Developmental care package
– Audio stimulation
– Measurement of the light level and noise level in the patient room
Result "Developmental care package" option [________OK]
2 Maintenance parts
This chapter contains information on maintenance parts, measures and tests.
2.1 Maintenance intervals, overview
The following table presents an overview of the required sets, maintenance

parts and intermittent activities over 12 years. After 12 years the table is
worked through again starting with the first year.
Designation Part number 1 2 3 4 5 6 7 8 9 10 11 12

(Option) replace 6873065
X X X X X X
O2 sensors (2)
Humidifier 2M61056 X X X X
Seals (2) for 2M60319
X X
incline motors
Lithium button cell 1888838
X X
3 V/195 mAh
Fan motor 2M60308 X X
(Option) visual inspection of the inner
compressed gas hose (6 years after
X X X X
commissioning. If no replacement is
required, re-check every 24 months.)
No.2001_0000009935

Babyleo TN500
Maintenance parts
2.2 Maintenance parts by specified interval
2.2.1 (Option) O2 sensors
Quan- Designation Part number Location/Remark

tity
2 O2 sensors 6873065 Sensorbox/replacement by
maintenance personnel
Result O2 sensors
Next replacement: [________dat]
2.2.2 Humidifier

tity
1 Humidifier 2M61056 Casing with patient
room/replacement by spe-
cialist maintenance person-
nel
Result Humidifier
2.2.3 Seals for incline motors

tity
2 Seal for incline motor 2M60319 Casing with patient
nel
Result Seal for incline motor

2.2.4 Lithium button cell 3 V/195 mAh

tity
1 Lithium button cell 1888838 Trolley, drawer and lower
3 V/195 mAh casing/replacement by spe-
nel
Result Lithium button cell 3 V/195 mAh

No.2001_0000009935

Babyleo TN500
Electrical safety
2.2.5 Fan motor

tity
1 Fan motor 2M60308 Casing with patient
nel
Result Fan motor

2.2.6 (Option) Visual inspection of the inner compressed gas hose

Action • Check 6 years after commissioning. If no replacement is required, re-check
every 24 months. Check by maintenance personnel.
Test The inner compressed gas hose is not damaged (e.g. porous or cracked) and
the hose connections have no visible leaks.
Result Check the inside of the compressed gas hose [________dat]
2.3 Maintenance parts as required
Designation Part number Location/Remark

Fresh air filter (set, MX17015 Sensor box
20 units) Replacement by user
Label set for 2M60683 After a preparatory calibration test starting with SW
TN500 scale 1.05. Replacement by maintenance personnel
3 Electrical safety
This chapter contains tests on the electrical safety.

Perform the tests according to IEC 62353 or IEC 60601-1 (depending on the
national guidelines. In Germany, for example, standard DIN EN 62353
applies).
3.1 Electrical safety according to IEC 62353

Introduction
NOTE
The device corresponds to the conditions in class I, skin temperature
sensors, scale (optional) and heated mattress (optional) type BF.
No.2001_0000009935

Babyleo TN500
Electrical safety
NOTE
The tester, e.g., SECUTEST, must be correctly configured for all
measurements. If implausible measurement results are obtained, such as a
leakage current of 0.0 µA, check the tester configuration in addition to the test
setup.
NOTE
– In testing to IEC 62353, the medical electrical device (ME device) or the
medical electrical system (ME system) must be tested.
– ME systems must be treated like ME devices.
– An ME system is a combination of several devices, as specified by the
manufacturer (of which at least one must be an ME device), which are
interconnected by a functional connection or by means of a multiple socket
outlet.
NOTE
With devices that are connected to other devices by means of a data cable,
this connection must be disconnected prior to performing the electrical safety
check, in order to avoid incorrect measurements.
NOTE
If the leakage current value is elevated, operate the device in radiant warmer
mode at 100 % heating performance for 15 minutes and repeat the
measurement.
3.1.1 Visual inspection

Prerequisites The tester and the device under test are switched off.
Test – The power supply cord and the mains plug are not dirty or damaged.
Result Visual inspection [________OK]
3.1.2 Protective earth resistance measuring points

Action • Scan the following measuring points one after the other with the tip of the
probe cable while measuring the protective earth resistance:
– Equipotential bonding pins
– Fastening screw from the thermal emitter's grid
– Fastening screw for the rear wall of the column
– Standard rail on the "front side"
Result The measuring points for the protective earth resistance are known [________OK]
No.2001_0000009935

Babyleo TN500
Electrical safety
3.1.3 Protective earth resistance

Test set-up
1936
Fig. 1 Protective earth resistance
Item Designation
1 Tester
2 Device under test
3 Probe cable with test probe
L Conductor
N Neutral conductor
PE Protective earth
Action • Prepare the test setup.

• Switch on the tester.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the probe cable, scan each of the measuring points on the
device under test listed under "Protective earth resistance measuring
points" one after the other, moving the power cable along the entire length
during the measurement. The resistance must not change when you do so.
Test The protective earth resistance of devices with detachable but connected
mains power cables must not exceed 0.3 Ω in each case.
Result Maximum measured value of device with power cable [________Ω]
3.1.4 Equipment leakage current, test adapter for applied parts

Prerequisites The following device-specific test adapters are required for the device under
test:
– 7910484, adapter to connect the central skin temperature sensor (yellow)
and to connect the peripheral skin temperature sensor (white)
Result Test adapters are available [________OK]
3.1.5 Device leakage current
NOTE
No.2001_0000009935
– The device leakage current can be tested according to the differential cur-
rent or direct measurement method.
– For direct measurement, the device under test must be insulated.

Babyleo TN500
Electrical safety
Prerequisites The tester is switched on.

Test set-up
30232
Fig. 2 Device leakage current pursuant to the differential current
measurement
Item Designation
1 Tester
2 Device under test
3 Device-specific test adapter for the device under test (application part)
4 Configurable ports for application components
L Conductor
N Neutral conductor
PE Protective earth

• Connect the device-specific test adapter to the device under test and the
test unit.
• Follow the instructions on the tester.
NOTE
– The test must be performed twice on symmetrical power plugs. In the sec-
ond test the power plug must be rotated through 180° before being
plugged into the socket. In many test devices the mains plug rotation is
simulated by means of a built-in selector switch.
– The higher measured value must be documented.
NOTE
The first measured value must be transferred to the test report as the
reference value.
Test The reference value must not exceed 500 µA.

Result Reference value [________µA]
NOTE
If the measured values are between 90% and 100% of the permissible limit
No.2001_0000009935
value, the reference value and the previously measured recurrent

measurement values must be applied to assess electrical safety.

Babyleo TN500
Electrical safety
Test The recurrent test value must not exceed 500 µA.
Result Recurrent test [________µA]
3.1.6 Applied part leakage current, mains on applied part, type BF

Test set-up
31722
Fig. 3 Leakage current on applied part
Item Designation
1 Tester
2 Device under test
3 Device-specific test adapter for the medical device (applied part)
L Conductor
N Neutral conductor
PE Protective earth

• Connect the device-specific test adapter (to the application part) to the
device under test on the one side and the test unit on the other.
NOTE
NOTE
The first measured value must be transferred to the test report as the
reference value.
3.1.6.1 Central skin temperature sensor (yellow)

No.2001_0000009935
Test The measured value must not exceed 5000 µA.


Babyleo TN500
Electrical safety
Test
NOTE
The measured value must not exceed 5000 µA.

3.1.6.2 Peripheral skin temperature sensor (white)

Test
NOTE
The measured value must not exceed 5000 µA.

3.2 Electrical safety according to IEC 60601-1

Introduction
NOTE
The device corresponds to the conditions in class I, skin temperature
sensors, scale (optional) and heated mattress (optional) type BF.
NOTE
The tester, e.g., SECUTEST, must be correctly configured for all
measurements. If implausible measurement results are obtained, such as a
leakage current of 0.0 µA, check the tester configuration in addition to the test
setup.
NOTE
For tests pursuant to IEC 60601-1, both the medical-electrical device (ME
device) as well as the medical electrical system (ME system) need to be
tested.
ME systems must be treated like ME devices.
An ME system is a combination of several devices, as specified by the
manufacturer, of which at least one must be an ME device, which are
interconnected by a functional connection or by means of a multiple socket
outlet.
NOTE
No.2001_0000009935
With devices that are connected to other devices by means of a data cable,
this connection must be disconnected prior to performing the electrical safety
check, in order to avoid incorrect measurements.

Babyleo TN500
Electrical safety
NOTE
If the leakage current value is elevated, operate the device in radiant warmer
mode at 100 % heating performance for 15 minutes and repeat the
measurement.
3.2.1 Visual inspection

Prerequisites The tester and the device under test are switched off.
Test – The power supply cord and the mains plug are not dirty or damaged.
Result Visual inspection [________OK]
3.2.2 Protective earth resistance measuring points

Action • Scan the following measuring points one after the other with the tip of the
probe cable while measuring the protective earth resistance:
– Equipotential bonding pins
– Fastening screw from the thermal emitter's grid
– Fastening screw for the rear wall of the column
– Standard rail on the "front side"
Result The measuring points for the protective earth resistance are known [________OK]
3.2.3 Protective earth resistance

Test set-up
1936
Fig. 4 Protective earth resistance

Item Designation
1 Tester
2 Device under test
3 Probe cable with test probe
L Conductor
N Neutral conductor
PE Protective earth
No.2001_0000009935

Babyleo TN500
Electrical safety

• Switch on the tester.
• Configure the tester appropriately, and follow the instructions on the tester.
• Using the tip of the probe cable, scan each of the measuring points on the
device under test listed under "Protective earth resistance measuring
points" one after the other, moving the power cable along the entire length
during the measurement. The resistance must not change when you do so.
Test The protective earth resistance of single devices (ME devices), including the
permanently installed power cable, or power cable detachable only by use of
tools, must not exceed 0.2 Ω in each case.
Result Maximum measured value [________Ω]
3.2.4 Earth leakage current
NOTE
– The ground leakage current can be tested pursuant to the differential cur-
rent measurement or direct measurement.
– For direct measurement, the device under test must be insulated.
Test set-up
30611
Fig. 5 Ground leakage current pursuant to the differential current

measurement
Item Designation
1 Tester
2 Device under test
L Conductor
N Neutral conductor
PE Protective earth

• Switch on the tester and the device under test.
No.2001_0000009935

Babyleo TN500
Electrical safety
NOTE
– The test must be performed twice on symmetrical mains plugs. In the sec-
ond test the mains plug must be rotated through 180° before being
Test The value must not exceed 500 µA.

Result Normal condition (N.C.) [________µA]
Test The value must not exceed 1000 µA.

Result Single fault condition (S.F.C.) [________µA]
3.2.5 Test adapters for patient leakage current

Prerequisites The following device-specific test adapters are required for the device under
test:
– 7910484, adapter to connect the central skin temperature sensor (yellow)
and to connect the peripheral skin temperature sensor (white)
Result Test adapters are available [________OK]
3.2.6 Patient leakage current

Test set-up
31722
Fig. 6 Patient leakage current, mains on the application part

Item Designation
1 Tester
2 Device under test
3 Device-specific test adapter for the medical device (applied part)
L Conductor
N Neutral conductor
PE Protective earth
No.2001_0000009935

• Connect the device-specific test adapter (to the application part) to the
device under test on the one side and the test unit on the other.

Babyleo TN500
Function and condition test
NOTE
3.2.6.1 Central skin temperature sensor (yellow)


3.2.6.2 Peripheral skin temperature sensor (white)


4 Function and condition test
This chapter contains condition and function tests.
4.1 Condition tests
4.1.1 Accompanying documents

Test – The instructions for use are available according to the user/owner.
– Only applicable in Germany: the medical product log is available (accord-
ing to user/owner).
Result Instructions for Use [________OK]
4.1.2 Product labels

Test – The product tags are complete and legible.
No.2001_0000009935

Babyleo TN500
NOTE
Read off the scale type, the number of adjustments, and the Change counter
of the change in the geographical data (Geographical position) on the
corresponding labels and enter these in the device configuration for the
scale.
Skin-temperature sensors Explanation

Bushings for main temperature sensors:
Central skin temperature (yellow),
peripheral skin temperature (white)
Scale (option) Explanation

Bushing for the scale
Seal for the scale (screw cover, 6x avail-

able)
No.2001_0000009935

Babyleo TN500

Label on the rear column wall (1st figure
of the name plate (Babyleo TN500), 2nd
Figure of the scale data (compare serial
numbers as described in device configu-
ration).
Lower software 1.05 Label: (First (NAWI scales only) and

second figure on the side of the scale,
3rd figure on bottom of scale (compare
serial numbers as described in device
configuration)
No.2001_0000009935

Babyleo TN500

As of software 1.05 Label: (First (NAWI scales only) and
second figure on the side of the scale,
3rd figure on bottom of scale (compare
serial numbers as described in device
configuration)
Audio connection (option) Explanation

Bushing for the audio connection
Oxygen connection (option) Explanation

Connections for oxygen (oxygen cylin-
der or wall extraction point)
Cylinder mount (option) Explanation

Oxygen cylinders only on this side of the
device (right side of the device, cylinder
mount)
No oxygen cylinders only on this side of

the device (left side of the device, cylin-
No.2001_0000009935
der mount)

Babyleo TN500
Radiant warmer Explanation

Do not cover the radiant warmer's venti-
lation openings (2x).
Warning: Hot surface (3x, radiant

warmer (1x) and next to the heating
plate (2x))
Intra-hospital transfer Explanation

Maximum permitted transfer height
exceeded (2x on the lifting column)
Warning: Risk of crushing for feet (2x on

the drawer casing), only for the "drawer"
option.
Maximum loading Explanation

Maximum loading (3x on the standard
rail) and, if available, the drawer
x
Maximum loading of the channel rail;
risk of toppling: Do not push or pull the
device sideways on the main column (2x
on the left and right side of the column).
Weight of the device and maximum total

weight of the device (1x on the rear wall
of the column)
No.2001_0000009935

Babyleo TN500
Heated mattress (option) Explanation

Bushing for the heated mattress
Humidification system Explanation

Bushing for the humidification system
(use aqua dist.).
Filter inlet Explanation

Keep oxygen sources away from the air-
inlet filter (1x in front of the PSU).
Swivel caster Explanation

Green arrow: Swivel caster moves in the
longitudinal direction (direction lock).
Green lock: Swivel caster is unlocked
(no direction lock).
Red lock: Swivel caster is locked.
Result Product tags [________OK]
4.1.3 Casing, complete

Action • Remove the following components:
– Heated mattress or SoftBed
– Mattress tray with the 2 mini walls
– Bed support with scale (option)
– T bars
– Small and large cover for the warm air duct
No.2001_0000009935

Babyleo TN500
Test The following components do not display any visible damage:

– Trolley and casing parts
– Drawer (option)
– X-ray drawer
– Heated mattress (option) or SoftBed mattress and bed
– T bars
– Fan impeller
– Incline motor and airflow sensor seals
– Sealing for the heating plate of the incubator interior
– Sealing for the fan motor
– Check moisture outlet of humidifier for deformation and narrowing of cross-
section
– O2 outlet
– Hose ducts
– Sensor unit
– Control unit
– Main column, including alarm display
– Tubing and cables
– Filter mat (in the sensor wall)
– Holding arm (option)
– Strain relief for the compressed gas hose and cable
– Gas inlets (option)
– All pressure reducers (option)
– All gas cylinder mounts (option)
The device equipment is complete pursuant to the instructions for use.
Result Casing, complete [________OK]
Action • Re-assemble the following components:

– T bars
– Mattress tray with the 2 mini walls
– Heated mattress or SoftBed
No.2001_0000009935

Babyleo TN500
4.1.4 Hood
Test – The hood does not display any visible damage.
– The seals on the hood frame do not display any visible damage.
– The hood is firmly mounted to the hood arm.
– The hood is easy to open and close.
– The hood can be fully opened and is cushioned towards the end.
– When closing the hood, it lowers slowly and moves into the end position.
– The hood is in a level position.
– The hood arm is firmly mounted to the main column.
– The hood arm does not snag when in motion.
Result Hood and hood arm [________OK]
4.1.5 Access flaps and feedthrough openings

Test – The access flaps can be fully folded down, close evenly and securely lock
in place.
– The top edges of the access flaps are aligned.
– The X-ray flap can be opened and closed without any conspicuous noises.
The X-ray flap is flush-mounted. The air ducts are perfectly vertical.
– The feedthrough openings swing open up 90° when opening.
– When closing the feedthrough openings, the locking system independently
locks into place and securely closes the feedthrough opening.
– No conspicuous noises can be heard when locking the feedthrough open-
ings.
Action • "Use a spring scale with pressure set" to internally (Fig. 7) load every
access flap for the feedthrough openings with a horizontal force of 20 N
(display on the spring scale = 2000 g) for 5 S.
32257
Fig. 7 Pressure point on the access flaps of the feedthrough openings

No.2001_0000009935
Test The respective feedthrough opening must not open.

Result Access flaps and feedthrough openings [________OK]

Babyleo TN500
4.1.6 Castors
Test – The castors do not display any visible damage.
– The steering function of the castors is in order.
– The castor brakes lock and the device cannot be moved when the brakes
are engaged.
Result Castors [________OK]
4.2 Function tests
4.2.1 Power-on test

Prerequisites – The device is fully set up.
– The power plug is connected.
Action • Switch on the device.
Test – When turning on the device, 2 acoustic signals sound and the alarm light is
alternately illuminated in yellow and red.
– After the self-test, the device is ready for operation.
Result Power-on self-test [________OK]
4.2.2 Height adjuster
NOTE
If the height adjustment has been operated for 2 minutes, the height
adjustment requires about 18 minutes to cool down. The height adjustment
cannot be operated during this time.
Action • Move the lifting column up to the end position from one side.
Test – The lifting column moves up smoothly and evenly.
– No scratching or scraping noises can be heard during the upwards move-
ment.
– The lifting column stops in the top end position.
– When the lifting column is fully extended, the label for the transfer height is
visible on both sides of the lifting column.
Action • Move the lifting column down to the end position from the same side.
Test – The lifting column moves down smoothly and evenly.
– No scratching or scraping noises can be heard during the downwards
movement.
– The lifting column stops in the bottom end position.
Action • Test the function of the foot pedals from the other side (briefly move up and
down).
Test – The foot pedals respond in accordance with the control logic.
No.2001_0000009935
Action • Move the lifting column to a desired position for further testing.
Result Lifting column adjustment [________OK]

Babyleo TN500
Action • Raise and lower the bed to the maximum positions.

• Change the incline of the bed.
Test – The bed moves up and down smoothly and evenly.
– No scratching or scraping noises can be heard during the height adjust-
ment.
– The bed stops in the respective end position.
– The incline of the bed can be adjusted.
– The two bed control panels respond in line with the control logic.
Action • Move the bed to a flat position.
Result Bed adjustment [________OK]
Action • In the service menu (0000) (Operating Data -> Lifting Column) read and
record the Operating parameter. Operating parameter 1 must amount to a
maximum of 7680. If the operating parameter exceeds this value, a new
lifting column must be installed.
Result Operating parameter 1 of the lifting column [________]
Action • Operating parameter 2 must amount to a maximum of 576. If the operating

parameter exceeds this value, a new lifting column must be installed.
Result Operating parameter 2 of the lifting column [________]
4.2.3 Operating mode

Action • Open the hood.
Test The device switches to radiant warmer mode.
Action • Set the radiant warmer to 100% power.
• Operate the radiant warmer until the heating element next to the column
glows red.
Test The other heating element is gray/brown.
Action • Adjust the radiant warmer's power to 30%.
• Close the hood.
Test The device switches to incubator mode.
Action • Operate the device for at least 30 seconds in incubator mode.
Test No error messages appear.
Result Changing over the mode of operation [________OK]
4.2.4 Air temperature and humidity control

Prerequisites – The device is in "Air temperature mode".
– The mattress heater is switched off, if present.
– The radiant warmer is switched off.
– Sufficient water for the humidifier is available.
No.2001_0000009935

Babyleo TN500
NOTE
The temperature and humidity are measured with different sensors.
Both sensors must be connected to the humidity and temperature
measuring device.
– Connection 1 = Humidity / temperature sensor (for measuring the humidity)
– Connection 2 = Precision temperature sensor (for measuring the tempera-
ture)
The humidity and temperature measuring device must be configured
accordingly (see also the operating instructions for the humidity and
temperature measuring device).
Test set-up
40333
Fig. 8 Test setup for measuring the temperature and humidity
Item Designation
1 Humidity / temperature sensor
2 Precision temperature sensor
Action • Set the air temperature to 36.0 °C.

• Set humidity control to 70 %.
• Position the sensors centrally 10 cm above the mattress tray (e.g., using a
hose strap, see Fig. 8).
• Measure the temperature in the incubator with the humidity and
temperature measuring device (wait until the warm-up phase has ended).
Test The reading on the control unit deviates by max. 0.8 °C from the reading on
the humidity and temperature measuring device. Both values lie within a
range from 35.2 °C to 36.8 °C.
Result Air temperature control 36 °C [________OK]
Action • Measure the humidity in the incubator with the humidity and temperature
measuring device (wait until the warm-up phase of the evaporator has
ended).
Test The reading on the control unit deviates by max. 10 % from the reading on
the humidity and temperature measuring device. Both values lie within a
range from 60 % to 80 %.
No.2001_0000009935
Action • Stop the water supply.

Babyleo TN500
Test Once the water has been consumed, a message indicating that the water
level is too low appears.
Result Humidity control [________OK]
Action • Reconnect the water supply.

• Switch off humidity control.
4.2.5 (Option) Adjusting (aligning) the O2 sensors

Prerequisites The O2 sensors have warmed up (in operation for at least 30 minutes).
In the incubator, the oxygen concentration amounts to 21% (if the device has
been operated at a higher oxygen concentration, ventilate the device well
(open the hood and side walls and close after ventilation)).
Action • Adjust (align) the O2 sensors. The O2 sensors can be adjusted in the
service menu (0000).
Test After adjustment, the current O2 concentration and the date of next
adjustment is displayed.
Result Adjust (align) the O2 sensors [________OK]
4.2.6 (Option) O2 control

Prerequisites The device is equipped with O2 (option)
The device is connected to an oxygen cylinder or the central O2 supply.
Action • Set the O2 control to 50 Vol% (advanced area).
• Use the external oxygen measuring device to measure the oxygen
concentration. To do so, place the O2 sensor 10 cm over the center of the
resting area.
Test The reading on the control unit deviates a maximum of 3 Vol% from the
reading on the measuring device. Both values lie within the range of 47 Vol%
to 53 Vol%.
Action • Turn off the O2 control.
Result (Option) O2 control [________OK]
4.2.7 Skin temperature control

Action • Plug the test connectors for the skin temperature sensors (Test connector
36 °C) into the connector sockets.
• Switch to "Skin temperature control mode".
Test The readings on the control unit for the measured values of the skin
temperature sensors lie within a range from 35.8 °C to 36.2 °C.
Result Skin temperature control [________OK]
4.2.8 Sensor test (skin temperature sensors)

Action • Pull out the test connector of the central skin temperature sensor (yellow).
No.2001_0000009935
Test A visual and acoustic alarm is triggered after about 5 seconds.

A message that the sensor is not connected appears on the display.

Babyleo TN500
Action • Insert the test connector of the central skin temperature sensor (yellow).
Test The alarm disappears.
Action • If necessary, reset the message.
• Pull out the test connector of the peripheral skin temperature sensor
(white).
Test A visual and acoustic alarm is triggered after about 5 seconds.
A message that the sensor is not connected appears on the display.
Action • Insert the test connector of the peripheral skin temperature sensor (white).
Test The alarm disappears.
Action • If necessary, reset the message.
Result Sensor test (skin temperature sensors) [________OK]
4.2.9 Metrological check
NOTE
If necessitated by applicable regulations, the following measuring functions
must be checked at the specified intervals.
Prerequisites The measuring range for the skin temperature sensors is active.
Action • Instead of the skin temperature sensors, connect the resistance decade
and set the relevant resistances (for the central skin temperature sensor
(yellow) and the peripheral skin temperature sensor (white)).
Resistance Temperature
1586 Ω 33.2 °C
1412 Ω 36.0 °C
1312 Ω 37.8 °C
Test The displayed temperature measurement value deviates from the

temperature value that is simulated by the respective resistance by a
maximum of 0.2 °C.
Action • Enter the date of the next “measurement check”.
Result Metrological control of the body temperature measurement [________dat]
4.2.10 (Option) Standard scale up to Babyleo TN500 software 1.04
NOTE
Always wear gloves when handling the test weights.
No.2001_0000009935

Babyleo TN500
Prerequisites – 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.
– The scale has been warming up for at least 12 minutes.
– The device is used in radiant warmer operation (with hood open).
– The mattress tray is in the topmost position.
– The side access panels are folded down.
– The device is not located within a draft (e.g., from air conditioning).
– The bed support is positioned stably on the T-bars and is not inclined to
one side.
– The trolley brakes are engaged.
– Attachments, such as supply and discharge hoses, have been removed.
– The air bubble on the spirit level is within the black ring and does not touch
the ring.
NOTE
The SoftBed or heated mattress is on the mattress tray. Called "mattress" in
the following.
Test set-up
35700
Fig. 9 Support point (A) for the test weight

No.2001_0000009935

Babyleo TN500
Action • Place a weight of 5 kg in a central position on the mattress tray 3x for 10

seconds (used to set the scale).
• Remove the weight of 5 kg from the mattress tray.
• Place a weight of 1 kg on the center (A) of the mattress.
• Switch to the scale menu and tap the button to weigh the patient.
• Lift the weight and wait for taring to take place.
• Place the 1 kg weight back on the center (A) of the mattress.
Test The displayed weight is 1000 g (+/-5 g SW 1.02), (+/-10 g SW 1.04).
Action • Place an additional weight of 5 kg on the center (A) of the mattress.
• Tap the button to weigh the patient once again.
Test The displayed weight is 6,000 g (+/-10 g SW 1.02), (+/-20 g SW 1.04).
NOTE
If the specified values are not attained, repeat the test procedure up to two
times. If the target values are still not reached, carry out an adjustment and
repeat the test.
Result Testing the scale [________OK]
Action • Remove the test weights.

• Fold up the side access panels.
4.2.11 (Option) Standard scale as of Babyleo TN500 Software 1.05
NOTE
least 24 hours.
one side.
the ring.
No.2001_0000009935

Babyleo TN500
Action • Remove both mini walls from the mattress tray.

• If the heated mattress is available, disconnect the cable on the rear of the
sensor wall. Remove the heated mattress or the SoftBed from the bed.
• Tap the following buttons in the respective window:
– System setup...
– System
– Service. Enter the password 5700 and confirm with OK (for the device
configuration: Babyleo TN500 software version).
– Service menu. Confirm the notice being displayed.
– Make and confirm the appropriate selection:
44751
Fig. 10 Message starting with SW 1.05
– Operating Data
– Scale
• Place a weight of 5 kg in a central position on the mattress tray 3x for 10
seconds (used to set the scale).
• Remove the weight of 5 kg from the mattress tray.
• Regardless of the weight display Weight (full resolution) [g], press the
Compensate button.
NOTE
In the Scale offset compensation category, all values are depicted with "---":
– if compensation has not yet been performed
– if the zero point of the scale for compensation corresponds to the zero
point of the last adjustment to the nearest gram
The displayed values are not real-time values. The values always refer to the
last compensation performed.
The values Cal. offset shift per year [g/y] and Estimated offset in 1 year
[g] are only calculated and displayed if the compensation is carried out at
least 31 days after the last adjustment.
Test The compensation was carried out successfully.

The Estimated offset in 1 year [g] value is less than 1000 or "---."
No.2001_0000009935
The depicted value Weight (full resolution) [g] is in the range of -1 to 1.

Babyleo TN500
NOTE
If the compensation was not successful or if the Estimated offset in 1 year
[g] value is greater than 1000, the scale must be adjusted.
Test set-up
35700
Fig. 11 Support point (A) for the test weight
Action • Place a weight of 1 kg on the center (A) of the mattress tray.

Test The displayed weight amounts to 1000 g +/-10 g.
Action • Place an additional weight of 5 kg on the center (A) of the mattress tray.
Test The depicted weight Weight (full resolution) [g] is 6000 g +/-20 g.
NOTE
times. If the target values are still not reached, carry out an adjustment and
repeat the test.
Result Testing the scale [________OK]
Action • Remove the test weights.

• Place the mattress / heated mattress on the mattress tray and connect
them.
• Mount the mini walls.
No.2001_0000009935

Babyleo TN500
4.2.12 (Option) NAWI scale with Babyleo TN500 software below 1.04
NOTE
Next perform either the in-service test (service inspection) or the pre-
verification test.
4.2.12.1 Labeling
Identifier of the NAWI scale
41318
Fig. 12 Sticker on the NAWI scale: right (Scale TN500, NAWI compliant)
may not include a bar code, e.g. when manually replacing the
sticker)
NOTE
The following describes two different types of test – the in-service test
(service inspection) and the pre-verification test – for scales subject to
mandatory verification.
In-service test (service inspection)

The in-service test for the NAWI scale takes place in accordance with the
specifications of the permissible tolerance limits and the defined intervals.
Pre-verification test
The preparatory calibration test is based on the error limits and suggests that
the calibration of the NAWI scale is passed by the national authority or
authorized specialist personnel.
Verifying the NAWI scale (option)
Information on the manufacturer's conformity assessment and the verification
prior to initial installation at the place of use is provided on a product tag. The
scale can be operated within the defined measurement uncertainty in the
specified zone.
The verification becomes invalid once the verification period has expired. The
verification also becomes invalid in the following cases:
– Illegible or damaged main stamp or security stamp
– Change to the service dialog by pushing the Adjust button
– Transgression of the tolerance limits
– Change the Geographical position in the service menu
No.2001_0000009935
In these cases, an official re-verification in accordance with the national

regulations is required. Calibration of the scale may only be carried out by
authorized expert personnel. The national calibration periods are to be

Babyleo TN500
considered. Maintenance personnel may perform a corresponding scale test

to ensure that the scale operates correctly and accurately. Please contact
DrägerService for more information.
Before the expiry of the verification deadline, re-verification must be carried
out in accordance with national regulations.
NOTE
The pre-verification test only needs to be performed if the date for the next
verification is before the next in-service test (service inspection) of the scale
or if the no fixed intervals are set for the verification.
The pre-verification test only needs to be performed if verification of the scale
is not scheduled soon, or in countries/regions where the NAWI/OIML
standard does not apply.
NOTE
The following details the in-service test (service inspection) and pre-
verification test procedures.
4.2.12.2 Test preparation
least 24 hours.
one side.
the ring.
NOTE
the following.
No.2001_0000009935

Babyleo TN500
Action • Place a weight of 10 kg (2x5 kg) in a central position on the mattress tray
3x for 10 seconds (used to set the scale).
– System setup...
– System
– Service. Enter the password (password upon delivery 0000) and confirm
with OK (for device configuration: Babyleo TN500 software version).
– Operating Data
– Scale
NOTE
Read off the following parameters and enter them in the device configuration
for the scale:
– Serial number (serial number)
– Softwareversion (software version)
– Geographical position: Change counter (counter for the change of geo-
graphical data)
– Number of adjustments (number of adjustments)
• Check whether the displayed weight "Weight (gross) [g]" with fitted mini
walls and mattress is at least 1 g.
NOTE
If, in the Service menu, the display "Weight (gross) [g]", with the mattress and
fitted mini walls on the mattress tray, does not indicate at least 1 g, then the
scale presented for the test is not calibratable.
If required by national regulations or laws, inform the customer that he or she
may no longer maintain and operate the scale. The non-calibratable scale
can be deactivated in the Service menu (password upon delivery "0000").
• Remove both mini walls from the mattress tray.

• Check in the Service menu that the display "Weight (gross) [g]", without the
mattress and mini walls on the mattress tray, indicates "---".
NOTE
If, in the Service menu, the display "Weight (gross) [g]", without the mattress
and mini walls on the mattress tray, does not indicate "---", then the scale
presented for the test is not calibratable.
If required by national regulations or laws, inform the customer that he or she
may no longer maintain and operate the scale. The non-calibratable scale
can be deactivated in the Service menu (password upon delivery "0000").
• Fit the mini walls and apply balancing weights (e.g., Allen keys) to change
the "Weight (gross) [g]" display so that the display is within the range of
1 g to 30 g.
No.2001_0000009935

Babyleo TN500
NOTE
If the "Weight (gross) [g]" is greater than 60 g, the scale may not be able to
measure the 10 kg. In this case, only the message that the maximum weight
has been exceeded appears.
If the "Weight (gross) [g]" weight of 1 g leads to measurement problems,
place an additional small weight on the scale.
Result Preparing for testing [________OK]
4.2.12.3 In-service test (service inspection)
NOTE
The in-service test (service inspection) of the NAWI scale is performed yearly
according to the specified maximum permissible errors in service.
NOTE
Prerequisites – The test preparation has taken place.

– The device is in the menu for weighing the patient.
No.2001_0000009935

Babyleo TN500
Test set-up
30573
Fig. 13 Support points (A to E) for the test weight

Item Designation
A Center of mattress
B Front right
C Front left
D Back right
E Back left
Action • Perform all measurements from measurement 1 to measurement 6 in

accordance with the following table. Then perform the measurements from
measurement 6 to measurement 1.
Test Measurement Measurement Measurement Measurement Measurement 5/ Measurement 6/

weight 1/ Test posi- 2/ Test posi- 3/ Test position 4/ Test position Test position Test position
tion tion
100 g -- -- -- C C --
200 g C C C C -- --
500 g -- E E, D E, D -- --
1000 g -- -- -- B -- --
5000 g -- -- -- -- A A, A
Target 200 g +/-5 g 700 g +/-5 g 1,200 g +/-5 g 2,300 g +/-5 g 5,100 g +/-10 g 10,000 g +/-10 g
No.2001_0000009935

Babyleo TN500
NOTE
times. Before starting the repeat measurements, check whether the mattress
tray is correctly positioned on the weighing pins and whether any shunt forces
are present, such as the mattress tray abutting the double wall or connections
between the intermediate element and the mattress tray. If the target values
are still not reached, carry out an adjustment and repeat the test. A new
calibration must then be carried out.
Action • Remove the weights and the balancing weights.

• Fit the mattress. If the heated mattress is present, remove the mini wall
that is closer to the column. Pull the cable through the hose feed-through in
the center of the sensor wall. Push the cable into the cable guide and
insert the connector on the back of the sensor wall.
• If necessary, fit the removed mini walls.
Result In-service test (service inspection) [________OK]
4.2.12.4 Pre-verification test
NOTE
The pre-verification test is performed prior to verification of a scale. The scale
can only be verified by a local measurement authority and the respective
verification authority.
NOTE

No.2001_0000009935

Babyleo TN500
Test set-up
30573

Item Designation
B Front right
C Front left
D Back right
E Back left


tion tion
100 g -- -- -- C C --
200 g C C C C -- --
500 g -- E E, D E, D -- --
1000 g -- -- -- B -- --
5000 g -- -- -- -- A A, A
Target 200 g +/-0 g 700 g +/-0 g 1200 g +/-0 g 2300 g +/-0 g 5,100 g +/-5 g 10,000 g +/-5 g
No.2001_0000009935

Babyleo TN500
NOTE
are still not reached, carry out an adjustment and repeat the test. A
calibration shall then be carried out

Result Pre-verification test (inspection) [________OK]
4.2.13 (Option) NAWI scale with Babyleo TN500 software 1.04
NOTE
verification test.
4.2.13.1 Labeling
41237
Fig. 15 NAWI scale sticker: right (Scale TN500, NAWI compliant) may also
not include a bar code, e.g., when manually replacing the sticker).
The left sticker may vary depending on the delivery (see software
1.05).
No.2001_0000009935

Babyleo TN500
NOTE

specified zone.
NOTE
NOTE
No.2001_0000009935

Babyleo TN500
least 24 hours.
one side.
the ring.
NOTE
the following.
Action • Place a weight of 10 kg (2x5 kg) in a central position on the mattress tray
– System setup...
– System
– Service. Enter the password (password upon delivery 0000) and confirm
with OK (for device configuration: Babyleo TN500 software version).
– Operating Data
– Scale
NOTE
Read off the following parameters and enter them in the device configuration
for the scale:
– Serial number (serial number)
– Software version (software version)
graphical data)
– Number of adjustments (number of adjustments)
• Check whether the displayed weight "Weight (gross) [g]" with fitted mini
walls and mattress is at least 1 g.
No.2001_0000009935

Babyleo TN500
NOTE
If, in the Service menu, the display "Weight (gross) [g]", with the mattress and
fitted mini walls on the mattress tray, does not indicate at least 1 g, then the
scale presented for the test is not calibratable.
If required by national regulations or laws, inform the customer that he may
no longer maintain and operate the scale. The non-calibratable scale can be
deactivated in the Service menu (password upon delivery "0000").
• Remove both mini walls from the mattress tray.

sensor wall. Remove the mattress from the mattress tray.
• Check in the Service menu that the display "Weight (gross) [g]", without the
mattress and mini walls on the mattress tray, indicates "---".
NOTE
If, in the Service menu, the display "Weight (gross) [g]", without the mattress
and mini walls on the mattress tray, does not indicate "---", then the scale
presented for the test is not calibratable.
If required by national regulations or laws, inform the customer that he may
no longer maintain and operate the scale. The non-calibratable scale can be
deactivated in the Service menu (password upon delivery "0000").
• Fit the mini walls and apply balancing weights (e.g., Allen keys) to change
the "Weight (gross) [g]" display so that the display is within the range of
1 g to 30 g.
NOTE
If the "Weight (gross) [g]" is greater than 60 g, the scale may not be able to
measure the 10 kg. In this case, only the message that the maximum weight
has been exceeded appears.
If the "Weight (gross) [g]" weight of 1 g leads to measurement problems,
place an additional small weight on the scale.
NOTE
NOTE

No.2001_0000009935

Babyleo TN500
Test set-up
30573

Item Designation
B Front right
C Front left
D Back right
E Back left


tion tion
100 g -- -- -- C C --
200 g C C C C -- --
500 g -- E E, D E, D -- --
1000 g -- -- -- B -- --
5000 g -- -- -- -- A A, A
Target 200 g +/-10 g 700 g +/-10 g 1200 g +/-10 g 2300 g +/-10 g 5100 g +/-20 g 10000 g +/-20 g
No.2001_0000009935

Babyleo TN500
NOTE

NOTE
NOTE

No.2001_0000009935

Babyleo TN500
Test set-up
30573

Item Designation
B Front right
C Front left
D Back right
E Back left

Test Measurement Measurement Measurement Measurement 4/ Measurement Measurement 6/

weight 1/ Test posi- 2/ Test position 3/ Test position Test position 5/ Test position Test position
tion
100 g -- -- C -- -- --
200 g C C C -- C --
500 g -- E, D E, D -- E, D --
1000 g -- -- B -- B --
5000 g -- -- -- A A A, A
Target 200 g +/-0 g 1200 g +/-0 g 2300 g +/-0 g 5,000 g +/-0 g 7,200 g +/-10 g 10,000 g +/-10 g
No.2001_0000009935

Babyleo TN500
NOTE
are still not reached, carry out an adjustment and repeat the test. Afterwards
a calibration is to be carried out.

Result Pre-verification test (inspection) [________OK]
4.2.14 (Option) NAWI scale with Babyleo TN500 software 1.05
NOTE
verification test.
4.2.14.1 Labeling
44587
Fig. 18 Identifier of NAWI scale: M (the label on the right (Scale TN500,
NAWI compliant) may also not contain any bar code, e.g. if the label
is manually replaced)
No.2001_0000009935

Babyleo TN500
NOTE

specified zone.
NOTE
NOTE
No.2001_0000009935

Babyleo TN500
least 24 hours.
one side.
the ring.
NOTE
the following.
No.2001_0000009935

Babyleo TN500
Action • Remove both mini walls from the mattress tray.

– System setup...
– System
– Service. Enter the password 5700 and confirm with OK (for the device
configuration: Babyleo TN500 software version).
– Make and confirm the appropriate selection:
44751
Fig. 19 Message starting with SW 1.05
– Operating Data
– Scale
• Place a weight of 10 kg (2x5 kg) in a central position on the mattress tray
• Remove the weight of 10 kg (2x5 kg) from the mattress tray.
NOTE
NOTE

– Heated mattress or SoftBed and both mini walls are removed.
– The scale tab in the service menu is open.
No.2001_0000009935
Action • Regardless of the weight display Weight (full resolution) [g], press the
Compensate button.

Babyleo TN500
NOTE
In the Scale offset compensation category, all values are depicted with "---":
– if compensation has not yet been performed
– if the zero point of the scale for compensation corresponds to the zero
point of the last adjustment to the nearest gram
The displayed values are not real-time values. The values always refer to the
last compensation performed.
The values Cal. offset shift per year [g/y] and Estimated offset in 1 year
[g] are only calculated and displayed if the compensation is carried out at
least 31 days after the last adjustment.
Test The compensation was carried out successfully.

The Estimated offset in 1 year [g] value is less than 1000 or "---."
The depicted value Wert Weight (full resolution) [g] is in the range of -1 to
1.
NOTE
If the compensation was not successful or if the Estimated offset in 1 year
[g] value is greater than 1000, the scale must be adjusted.
Action • Read off the following parameters and enter them in the device
configuration for the scale:
– Serial number
– Software version
graphical data)
– Number of adjustments
No.2001_0000009935

Babyleo TN500
Test set-up
30573

Item Designation
A Center of the mattress tray
B Front right
C Front left
D Back right
E Back left

• Compare the target values with the value Weight (full resolution) [g].

tion tion
100 g -- -- -- C C --
200 g C C C C -- --
500 g -- E E, D E, D -- --
1000 g -- -- -- B -- --
5000 g -- -- -- -- A A, A
Target 200 g +/-10 g 700 g +/-10 g 1200 g +/-10 g 2300 g +/-10 g 5100 g +/-20 g 10000 g +/-20 g
No.2001_0000009935

Babyleo TN500
NOTE
Action • Remove the weights.

• Mount the heated mattress or the SoftBed.
• Fit the mini walls which have been removed.
NOTE
NOTE

– Heated mattress or SoftBed and both mini walls are removed.
– The scale tab in the service menu is open.
Action • Adjust the scale regardless of the weight display Weight (full resolution)
[g] and Estimated offset in 1 year [g].
No.2001_0000009935

Babyleo TN500
Test set-up
30573

Item Designation
A Center of the mattress tray
B Front right
C Front left
D Back right
E Back left

• Compare the target values with the "Weight (full resolution) [g]" value.
Test Measurement Measurement Measurement Measurement 4/ Measurement Measurement 6/

weight 1/ Test posi- 2/ Test position 3/ Test position Test position 5/ Test position Test position
tion
100 g -- -- C -- -- --
200 g C C C -- C --
500 g -- E, D E, D -- E, D --
1000 g -- -- B -- B --
5000 g -- -- -- A A A, A
Target 200 g +/-5 g 1,200 g +/-5 g 2,300 g +/-5 g 5,000 g +/-5 g 7,200 g +/-10 g 10,000 g +/-10 g
No.2001_0000009935

Babyleo TN500
NOTE
between the intermediate element and the mattress tray.
If necessary, repeat the adjustment of the scale.
Action • Remove the weights.

• Label new sticker for the scale with a waterproof pen, attach it and stick the
protective foil on it.
44595
Fig. 22 Label (1x) on the scale
• Place the heated mattress or SoftBed on the mattress tray and connect
them.
• Fit the mini walls which have been removed.
• Read off the following parameters and enter them in the device
configuration for the scale:
– Serial number
– Software version
graphical data)
– Number of adjustments
Result Pre-verification test [________OK]
4.2.15 Tests with the HIT software

Prerequisites The HIT software is started and the device is in "Product Test Mode."
No.2001_0000009935
The "IPM-L" tab in the HIT software is active.

Babyleo TN500
4.2.15.1 Nurse Call
Test set-up
30842
Fig. 23 Pin assignment for nurse call
HIT software Turn on the alarm for the nurse call.

Action • Measure the contacts for the nurse call using the multimeter.
Test Contacts 1 and 3 are open (high-resistance)
Contacts 1 and 2 are closed (low-resistance).
HIT software Turn off the alarm for the nurse call.
Test Contacts 1 and 3 are closed (low-resistance).
Contacts 1 and 2 are open (high-resistance).
Result Nurse call [________OK]
4.2.15.2 Fan wheel
HIT software Start the test for the fan wheel. The fan wheel is actuated between 300 and
3,000 rpm and then turned off.
Test No scratching or scraping noises can be heard.
Result Fan wheel [________OK]
4.2.15.3 O2 valve
Prerequisites The supply pressure for oxygen is available.

HIT software Open the O2 valve 50% and 100%. Read the respective current.
Test The opening current amounts to 0.148 A +/-0.02 A at 50% and 0.296 A +/-
0.02 A at 100%.
Result O2 valve [________OK]
Action • Remove the connection to the Service PC.

• Switch device off and on again.
4.2.16 Power failure alarm

No.2001_0000009935
Prerequisites The device is switched on.

Action • Disconnect the power plug from the socket-outlet.

Babyleo TN500
Test equipment
Test A loud acoustic signal sounds and the LED to display the power supply is
illuminated in red.
The acoustic signal must be able to be clearly audible for at least 10 minutes.
Action • Insert the power plug back into the power socket.
Test The acoustic signal falls silent and the LED to display the power supply is
illuminated in green.
Action • Switch on the device.
Test The device starts without error messages.
Result Power failure alarm [________OK]
4.2.17 Final action

Prerequisites – The test instructions have been performed as specified.
– All tests performed were passed successfully.
4.2.17.1 Device handover with test label
Action • Attach a test label to the device.

• Hand over the device to the user/operator.
Result Test label and device handover [________OK]
5 Test equipment
This section sets out the test equipment required for the tests in this test
procedure.
5.1 Test equipment subject and not subject to mandatory calibration
NOTE
Use the following test equipment or equivalent aids.
5.1.1 Test equipment subject to mandatory calibration
Part number Designation Figure/Comment

7910594 Tester for electrical safety, SECUTEST
No.2001_0000009935

Babyleo TN500
Test equipment

7911370 Spring balance with pressure set
7912121 Humidity-temperature measuring

device
7911314 Test connector 36 °C
7910120 Resistance decade
7911898 Set of weights to check the scale
7901021 Digital multimeter 4 1/2-digit

No.2001_0000009935
Test Valid calibrated test equipment was used.

Result Test equipment subject to mandatory calibration [________OK]

Babyleo TN500
Test equipment
5.1.2 Test equipment not subject to mandatory calibration

7910484 VDE adapter for heat therapy
8411075 Hose strap
7911955 MX 300-i oxygen monitor
7912018 Set Combination Blade 11prt.
7912146 Set hexagon socket 6 mm, 11-piece
7910304 Set Allen wrench

No.2001_0000009935

Baby Leo

Uploaded by

Copyright:

Available Formats

Baby Leo

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Baby Leo

Uploaded by

Copyright:

Available Formats

Test instructions / Service Card IPM-L

Basic safety information 5

3.2.5 Test adapters for patient leakage current .................................................................. 19

2 / 63 Test instructions / Service Card IPM-L | Revision 10 |

3.2.6.2 Peripheral skin temperature sensor (white) .......................................................... 20

| Revision 10 | Test instructions / Service Card IPM-L 3 / 63

5.1.2 Test equipment not subject to mandatory calibration ................................................ 63

4 / 63 Test instructions / Service Card IPM-L | Revision 10 |

Basic safety information

Inspection and servicing

| Revision 10 | Test instructions / Service Card IPM-L 5 / 63

This chapter contains test steps to document the configuration.

1.1 Software version

What is read Where Stan- NAWI

6 / 63 Test instructions / Service Card IPM-L | Revision 10 |

What is read Where Stan- NAWI

1.2.1.1 Type, software version and serial number

Result Scale type Standard scale [ ]

1.2.1.2 NAWI scale (geographical position)

| Revision 10 | Test instructions / Service Card IPM-L 7 / 63

Result Comparing the Change counter [________OK]

1.2.1.3 NAWI scale (adjustment data)

Result Comparing the Number of adjustments [________OK]

Result "Heated mattress" option [________OK]

1.2.4 Oxygen control

1.2.5 Mount for gas cylinders

8 / 63 Test instructions / Service Card IPM-L | Revision 10 |

1.2.6 Auto Thermo package

Result "AutoThermo package for additional treatment applications" option [________OK]

1.2.7 Developmental care package

Result "Developmental care package" option [________OK]

This chapter contains information on maintenance parts, measures and tests.

2.1 Maintenance intervals, overview

The following table presents an overview of the required sets, maintenance

Designation Part number 1 2 3 4 5 6 7 8 9 10 11 12

| Revision 10 | Test instructions / Service Card IPM-L 9 / 63

2.2 Maintenance parts by specified interval

2.2.1 (Option) O2 sensors

Quan- Designation Part number Location/Remark

Quan- Designation Part number Location/Remark

2.2.3 Seals for incline motors

Quan- Designation Part number Location/Remark

Result Seal for incline motor

2.2.4 Lithium button cell 3 V/195 mAh

Quan- Designation Part number Location/Remark

Result Lithium button cell 3 V/195 mAh

10 / 63 Test instructions / Service Card IPM-L | Revision 10 |

2.2.5 Fan motor

Quan- Designation Part number Location/Remark

Result Fan motor

2.2.6 (Option) Visual inspection of the inner compressed gas hose

2.3 Maintenance parts as required

Designation Part number Location/Remark

This chapter contains tests on the electrical safety.

3.1 Electrical safety according to IEC 62353

| Revision 10 | Test instructions / Service Card IPM-L 11 / 63

3.1.1 Visual inspection

3.1.2 Protective earth resistance measuring points

12 / 63 Test instructions / Service Card IPM-L | Revision 10 |

3.1.3 Protective earth resistance