supplement babyleo tn500 · 2020-05-05 · supplement | babyleo tn500 sw 1.0n 7 operation 5...

Supplement

Babyleo TN500

WARNING

To properly use this medical device, read and comply with the instructions for use and this supplement.

IncuWarmerSoftware 1.0n

2 Supplement | SW 1.0n

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Supplement | Babyleo TN500 SW 1.0n 3

Supplement to the instructions for use

Babyleo TN500

1 Supplement to the instructions for use

Keep this supplement with the instructions for use for the device.

This supplement updates the information of the instructions for use in the following chapters.

2 Information about this document

2.1 Trademarks

Trademarks owned by third-party manufacturers

The following trademarks have been added.

3 Safety-related information

3.1 Intended use

The IncuWarmer Babyleo TN500 is intended for use with premature babies and neonates and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer.

3.2 Indications

The IncuWarmer Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use:

– Temperature

– Humidity

– Oxygen (option)

Device Part number Edition

Babyleo TN500 SW 1.0n 9054863 Edition: 2 – 2017-01

Trademark Trademark owner

Cleanisept® Dr. Schumacher

Clorox Professional® Clorox

Oxygenon® Antiseptica

SteriMax® Aseptix

Surfa’Safe® ANIOS Laboratories

Tuffie® Vernacare

4 Supplement | Babyleo TN500 SW 1.0n

Safety-related information

3.3 Contraindications

Do not use Babyleo TN500 outside the specified environments of use.

3.4 Environments of use

The following chapter has been changed.

Babyleo TN500 provides controlled ambient conditions for premature babies and neonates in a hospital. Babyleo TN500 is intended for use in the following environments:

– Labor and delivery units

– Labor and delivery rooms

– Neonatal intensive care units

– Operating rooms

Babyleo TN500 is not intended for use in the following environments:

– Home use

– Transport vehicles, e.g., ambulances, airplanes, or helicopters

– MRI environment

The following restrictions apply during intrahospital patient transfer within the building:

– The warming therapy is deactivated.

– During intrahospital transfer, the patient is not actively supplied with heat, humidified air, or oxygen.

– The body core temperature of the patient must be monitored with an external temperature sensor.

– The patient’s state of health must be suitable for intrahospital transfer.Babyleo TN500 is not a transport incubator. The user bears the responsibility for intrahospital patient transfer. Observe the following information: "Intrahospital patient transfer with switched off warming therapy", page 21.

3.5 Electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. During installation and before initial operation, follow the information in section: "EMC declaration" (page 34).

This device can be affected by other electrical devices.

The following safety instruction has been added:


Safety-related information

3.5.1 Electromagnetic disturbances

The functional integrity of this device may be compromised by electromagnetic radiation from other devices. As a result, the patient could be put at risk. Electromagnetic radiation is emitted, e.g., by the following devices:

– Radio communications equipment (e.g., cellular phones)

– Medical electrical equipment (e.g., defibrillators, electrosurgical devices)

Maintain the following distances between the device, the cables for the device, and other devices:

With wireless communication devices, maintain a distance of at least 0.3 m (1.0 ft), to ensure that the essential performance is fulfilled.

With other medical electrical equipment, maintain an adequate distance.


Operating concept

4 Operating concept

The following text replaces the section Backlighting of the rotary knob in the instructions for use. Text change: The rotary knob flashes orange.

4.1 Display unit

4.1.1 Colors of the control elements

Backlighting of the rotary knob

When the device is ready for operation, the rotary knob is backlit in color. The following table shows the meaning of the colors:

System support for unconfirmed selections

Using the example of the tabs and therapy controls, the following points show how the device responds to an unconfirmed selection:

– If a selection has not been confirmed, a prompt indicates the unconfirmed function or setting.

– If a selection remains unconfirmed for more than 10 seconds, the prompt flashes blue. The backlighting on the rotary knob flashes orange and an acoustic signal sounds.

– If a selection remains unconfirmed for more than 15 seconds, the rotary knob and prompt stop flashing. The device resets the selection. An alarm text warns the user that the function or setting has not been adopted.

Color Meaning

Blue The most recently selected and confirmed therapy is running.

Orange The selected function or setting has to be confirmed with the rotary knob.


Operation

5 Operation

The following chapters and functions have been added:

– The Touch time function has been added.

– The ClearView function can be deactivated at any time on the main screen.

5.1 Overview of incubator operation

When the hood is closed, the device is automatically operated as an incubator. The device displays the user interface for incubator operation.

Fig. 1 Standard view in incubator operation with air temperature mode activated

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0No. Designation Description

1 Air temp. Shows the current air temperature measurement in the patient compartment.

2 Touch time Allows undisturbed patient care for 20 minutes:

– Intensifies the air curtain in the device

– Suppresses some alarms acoustically and visu-ally

3 ClearView Reduces condensation on the inside of the hood.

4 Therapy bar Shows the available modes in incubator operation. In this example, air temperature mode is activated.

1

4 3 2


Operation

5.1.1 Condensation management

High humidity settings may cause the inside of the hood to fog up. To limit fogging, the ClearView function can be activated. If the ClearView button is activated in the therapy bar, the radiant warmer operates at low power. This warms the hood, reducing fogging.

The Standard function or the Eco function can be selected for the transition between incubator operation and radiant warmer operation. The Standard function automatically activates the ClearView setting. The ClearView setting can be deactivated at any time on the main screen (e.g., during phototherapy).

5.2 Scale (option)

The following texts replace the chapter Scale (option) in the instructions for use. Zeroing the scale means that the weight of additional objects on the scale is deducted so that only the patient's weight is displayed.

5.2.1 Overview of the scale

The scale is integrated in the bed support. When weighing the patient, the objects resting on the mattress are also weighed. In order to precisely determine the patient's weight, the scale must be set to zero. In order to zero the scale, the patient must be lifted up so that the weight of the mattress tray and the objects resting on it can be determined. This weight is deducted from the measured weight when the patient is subsequently weighed so that only the patient's weight is displayed. An acoustic signal sounds when the scale is set to zero and also when the weighing process is complete. The patient can be weighed during incubator operation and radiant warmer operation.


Operation

Fig. 2 Scale dialog window

Offers access to a table of the last weight measurement with the following information: date and time, weight and manually adjusted weight. This button allows to switch between the graphical view and the tabular view.

Only one weight measurement per day is saved in the graphical view and the tabular view. Only the last measured value is saved.

5.2.2 Connecting the scale

Information about the NAWI scale (option) has been added.

NAWI scaleOnly use the NAWI scale that has been assigned to the respective Babyleo. If the NAWI scale is used in another Babyleo, the verification becomes invalid.

Prerequisites:

– The device has a connection for the scale (option).

– A scale is integrated in the bed support.

– The "Scale" software option is included in the device.

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No. Designation Description

1 Last weight Shows the last measured weight.

2 Weigh patient Activates the weighing process.

3 Weight [g] Shows the weight after weighing.

4 Adjusted weight The symbol indicates whether the measured weight was adjusted by the user.

1

2

4 3


Operation

WARNINGRisk of electric shockIf the contact pins are touched, the user and the patient will be exposed to the risk of an electric shock.

Do not touch the pins in the plug of the scale.

Procedure:

1. Make sure that the scale cable faces the sensor wall.

2. Place the bed support with the scale on the T-bars from above.

3. Pull the cable through the hose grommet in the center of the sensor wall and push it into the cable guide.

4. Make sure that the cable runs downward between the bed support and the sensor wall and is not caught.

5. Insert the gray plug for the scale into the gray socket on the rear of the sensor wall.

The scale is connected to the device.

5.2.3 Weighing

This chapter describes how to weigh the patient in the device.

Prerequisites:

– The device is in operation and the scale is connected.

– The bed support is resting securely on the T-bars and is not tilted to the side.

– The locking brakes are engaged.

– A mattress is placed on the mattress tray.

– The patient is lying in the center of the mattress.

WARNINGRisk due to measuring error or measuring inaccuracyIf the mattress tray is not horizontal during weighing or if the weight is falsified by hoses or cables, measuring errors or inaccuracies may occur.This may result in incorrect therapy decisions.

Always position the mattress tray horizontally before weighing.

Before weighing, make sure that the air bubble in the spirit level is within the black ring and is not touching the ring.

Make sure that cables (such as the heated mattress cable) are correctly routed and do not falsify the weighing result.

If a weighing result seems implausible, cross check it with a known weight value.

Double-check therapeutic decisions that are based on the patient's weight by performing a reference measurement using an external scale.

WARNINGMeasuring error due to incorrect zeroingIf zeroing is not performed before weighing, measuring errors may occur.

Set the scale to zero before each weighing process.


Operation

Procedure:

1. Touch the Scale button (1) in the main menu bar.

The dialog window Scale is displayed.

Fig. 3 Activating the Scale button

2. Place the mattress tray in a horizontal position using the mattress tray control panel and the spirit level. The mattress tray stops automatically once it reaches a horizontal position.

The air bubble in the spirit level is within the black ring and is not touching the ring.

Fig. 4 Note the spirit level

3. Proceed as follows in order to set the scale to zero:

– Keep as many hoses and cables that lead to the patient as possible off the mattress tray.

– Fasten the hoses and cables in the holders.

– Pull the hoses and cables tautly through the hose grommets.

This prevents hoses and cables from jamming the mattress tray or falsifying the weight measurement.

4. Touch the Weigh patient button (2).

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02

95

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2


Operation

5. To set the scale to zero, lift the patient up. At least 200 g (0.44 lbs) must be lifted off the mattress tray for the scale to be set to zero. Wait until a signal sounds.

The scale is set to zero.

Fig. 5 Zeroing the scale

6. Place the patient on the mattress.

The patient's weight is determined.

Once weighing is complete, a signal sounds.

The measuring result is displayed. The weight is also displayed as a trend.

7. To confirm the measuring result, touch the OK button.

8. To discard the measuring result, touch the Discard button.

The following note has been added:

The measurement result will also be saved automatically without confirmation.

5.2.4 Reweighing

The prerequisites have been added in this chapter.

If certain parts of the device are not moved for 6 minutes after the last weighing process, the patient can be reweighed without having to set the scale to zero again. The Scale dialog window must remain open.

Example: The patient's weight needs to be determined with a diaper and then without a diaper.

Prerequisites:

– The patient was weighed earlier and the Scale dialog window remains open.

– The following parts of the device were not adjusted, moved or opened within 6 minutes:

– Mattress tray

– Lifting column

– Hood

– Access panels

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Operation

WARNINGRisk due to zeroing of the scale not being performedWhen changes are made between measurements, measuring errors may occur if the scale is not set to zero, e.g., if the mattress tray is moved or adjusted or additional items are placed on the mattress tray.

Before carrying out another weight measurement, lift the patient up and set the scale to zero.

Procedure:

1. To weigh the patient again, touch the Reweigh button (1).

The measuring result is displayed.

The weight is also displayed as a trend.

Fig. 6 Buttons after a measurement has been made

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Operation

5.2.5 Adjusting the measured patient weight

The measured patient weight can be adjusted manually after weighing.

Example: After weighing, the weight of the diaper needs to be subtracted.

Procedure:

1. Touch the System setup... button in the main menu bar.

2. Touch the Therapy tab.

3. Enter the password and confirm.

4. Touch the Scale tab.

5. Touch the On button.

The weight can be adjusted manually in the Scale dialog window.

6. Switch to the Scale dialog window and weigh the patient. Observe the information in the following chapter: "Weighing", page 10

7. Enter a value in the Adjust weight [g] input field (1) and confirm with the rotary knob.

8. Confirm the adjusted weight with OK.

The measuring result is displayed in the dialog window. The adjusted weight values are highlighted in the graphical view and the tabular view. Only the last measured weight is displayed per day.

Fig. 7 Adjusting the measured patient weight2

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Alarms

6 Alarms

The following chapters have been added.

6.1 Alarm priorities and alarm signals

6.1.1 Acoustic alarm signals

In the event of an alarm, acoustic alarm signals are signaled as follows:

– The alarm with the highest priority is signaled acoustically. The alarm signal sounds until either the cause of the alarm is cleared or the "Audio paused" key is pressed.

– The low priority alarms only generate an acoustic alarm once.

6.1.2 Optical alarm signals

In the event of an alarm, optical alarm signals are signaled as follows:

– The alarm message is shown on the display. For some alarms, the parameter that triggers the alarm flashes.

– The alarm light on the main column only flashes for medium- and high-priority alarms.

6.2 Suppressing and delaying the alarm signal

The following texts have been added and replace the chapter Suppressing and delaying the alarm signal in the instructions for use.

6.2.1 Suppressing the acoustic alarm signal

This chapter describes how the acoustic alarm signal can be suppressed.

WARNINGRisk of patient injury due to suppressed alarm signalsIf the "Audio paused" key is activated, some acoustic alarm signals are suppressed. The patient may be put at risk.

Stay close to the device and monitor the patient.

Observe the alarm messages on the display.

Procedure:

1. Press the "Audio paused" key.

The symbol and the remaining time for the suppressed alarm signal are displayed in the header bar.

If the fault triggering the alarm is not eliminated after the suppression time has elapsed, the acoustic alarm signal sounds again.


Alarms

6.2.2 Stopping the suppression of the acoustic alarm signal

This chapter describes how to prematurely stop the suppression of the acoustic alarm signal.

Prerequisite:

– The "Audio paused" key is active.

Procedure:

1. Press the "Audio paused" key.

The symbol for the suppressed alarm signal is no longer displayed in the header bar.

6.2.3 Manually suppressing the acoustic alarm signal

The acoustic alarm signal for certain alarms can be suppressed for 2 to 15 minutes. The duration of the suppression is based on the urgency of the alarm. The device responds as follows:

– If several alarms are displayed, all alarms are suppressed by pressing the "Audio paused" key.

– The duration of the suppression is based on the urgency.

– The most urgent alarm determines the duration of suppression.

– If a new alarm occurs during this time, the alarm signal sounds and the suppression is canceled.

6.2.4 Proactively suppressing the acoustic alarm signal

This description assumes that the touch time option is installed. If the device is not equipped with the touch time option, the duration of the proactive alarm suppression is 4 minutes.

If the user is planning to operate the device and acoustic alarms are foreseeable, these alarms can be suppressed in advance for 20 minutes.

Example: The device will be operated in incubator mode with oxygen. The patient compartment must be briefly opened for therapeutic reasons (hood or access panel). In such cases, the oxygen concentration in the patient compartment will probably fall.

If the "Audio paused" key is pressed before the hood or access panel is opened, the device suppresses the alarm as follows:

– If the oxygen concentration falls, no acoustic alarm is generated for 20 minutes.

– The alarm light on the main column is suppressed for 20 minutes.

– In the header bar, the symbol and the remaining alarm silence time are displayed.

If an alarm occurs during the 20 minutes that has not been classified as a foreseeable alarm, the device responds as follows:

– The alarm suppression is canceled.

– The alarm signal sounds and the alarm is visually displayed.


Alarms

6.2.5 Touch time (option)

The touch time function can be activated in order to stabilize the climate in the patient compartment when the hand ports are open.

If the Touch time button is active, the device responds as follows:

– The rotation of the fan impeller is accelerated for 20 minutes and the warm air curtain in the patient compartment is intensified.

– Some alarms are suppressed acoustically for 20 minutes.

– The alarm light on the main column is suppressed for 20 minutes.

– In the header bar, the symbol and the remaining alarm silence time are displayed.

If an alarm occurs during the 20 minutes that has not been classified as a foreseeable alarm, the device responds as follows:

– The alarm suppression is canceled.

– The alarm signal sounds and the alarm is visually displayed.

– The touch time function remains activated.

– The fan impeller is still accelerated.

After 20 minutes, the device continues with the alarm settings that were active prior to touch time. The touch time is recorded in the logbook.

Touch time is terminated as soon as the hood is opened or kangaroo mode is started.

6.2.5.1 Activating touch time (option)

This chapter describes how touch time is activated.

Prerequisites:

– The device is operated in incubator operation.

– The touch time alarm suppression is only activated in the following cases:

– There is no alarm.

– There is a low priority alarm (turquoise).

– There is a touch time alarm.

WARNINGRisk of patient injury due to suppressed alarm signalsIf touch time is active, some acoustic alarm signals are suppressed. The alarm light on the main column is suppressed. The patient may be put at risk.

Stay close to the device and monitor the patient.

Observe the alarm messages on the display.


Alarms

Procedure:

1. Touch the Touch time button.

The button turns yellow.

2. Press the rotary knob to confirm.

The button turns dark green.

The duration of the alarm suppression is indicated by a symbol and a timer on the main screen.

Touch time is activated. Touch time ends automatically after 20 minutes or when deactivated.

6.2.5.2 Deactivating touch time (option)

This chapter describes how touch time is deactivated.

Prerequisite:

– The Touch time button is active and dark green.

Procedure:

1. Touch the Touch time button.

The button turns yellow.

2. Press the rotary knob to confirm.

The button turns light green.

Touch time is deactivated. The device continues with the alarm settings that were active prior to touch time.

6.2.6 Automatic delaying of acoustic and optical alarm signals

If the user switches on the device or changes settings that will probably result in alarms, the acoustic and optical alarm signal for some alarms will be automatically delayed. Whenever the settings are changed, the device checks whether an alarm condition exists. The device delays the output of the alarm signals for as long as it takes for it to reach the new values set by the user.

Example: The device is switched on when the room temperature is 23 °C (73.4 °F). An air temperature of 36.5 °C (97.7 °F) is set. For the period that the device was switched off, the current air temperature in the incubator was the same as the ambient temperature and lower than the set value. The device detects the warm-up phase and automatically suppresses the Air temperature low alarm for a maximum of 30 minutes.

When kangaroo mode is started, some alarms are delayed for 4 minutes, as these alarms are to be expected when the device is opened.

6.2.7 Duration of alarm suppression

The following table shows the foreseeable alarms and the duration of the alarm suppression when the device is equipped with the touch time option.


Alarms

Alarm Duration of man-ual alarm sup-pression (min)

Duration of pro-active alarm sup-pression (min)

Duration of pro-active alarm sup-

pression for touch time

(option) (min)

Duration of auto-matic delay of alarm signal (min)

Air temperature high

15 - - max. 30

Air temperature low

15 20 20 max. 30

Air temperature too high

5 - - max. 30

Ambient tempera-ture sensor faulty

2 - - -

Centr. sensor missing, heating off

5 - - -

Centr. temp. sen-sor faulty, heating off

5 - - -

Central skin temp. sensor faulty

5 - - -

Central skin temp. sensor missing

5 - - -

Central skin tem-perature high

15 - - -

Central skin tem-perature low

15 20 20 -

Central skin tem-perature too high

2 - - -

Device failure, heating off

2 - - -

Fan motor faulty, heating off

2 - - -

Humidity low - 20 20 max. 60

Internal tempera-ture high

2 - - -

Mattress faulty 2 - - -

Mattress tem-perature too high

2 - - -

Oxygen high 4 - - max. 30

Oxygen low 4 20 20 max. 10

Oxygen module faulty

2 - - -

Oxygen sensor faulty

2 - - -


Alarms

Peripheral skin temp. sensor faulty

5 - - -

Peripheral skin temp. sensor missing

5 - - -

Peripheral skin temperature high

15 - - -

Peripheral skin temperature low

15 20 20 -

Peripheral skin temperature too high

2 - - -

Skin temp. sen-sor faulty, heating off

2 - - -

Skin temperature difference high

15 20 20 -

Skin temperature difference low

15 20 20 -

Skin temperature high

15 - - 15

Skin temperature low

15 20 20 15

Temp. of convec-tive heater high

2 - - -

Temp. of humidi-fier heater high

2 - - -

Temperature high in warm air duct

5 - - -

Warmer off, check patient's condition

2 - - -

Water level low 15 20 20 -

Weaning failed 2 - - -

Alarm Duration of man-ual alarm sup-pression (min)

Duration of pro-active alarm sup-pression (min)

Duration of pro-active alarm sup-

pression for touch time

(option) (min)

Duration of auto-matic delay of alarm signal (min)


Transfer

7 Transfer

The following texts replace the chapter Transfer in the instructions for use.

7.1 Intrahospital patient transfer with switched off warming therapy

The following chapters have been changed.

7.1.1 Overview of intrahospital patient transfer with switched off warming therapy

The patient can be transported in the device within a building of the hospital, e.g., from the labor and delivery room to the neonatal intensive care unit. Warming therapy is interrupted during this time. The patient is not actively supplied with heat, humidified air, or oxygen.

The user bears the responsibility for intrahospital patient transfer and must ensure the following:

– The patient’s state of health is suitable for intrahospital transfer.

– The body core temperature of the patient is monitored with an external temperature sensor.

During intrahospital patient transfer, the air temperature in the patient compartment drops depending on the ambient temperature.

Examples for an ambient temperature of 23 °C (73.4 °F):

– The set air temperature in the patient compartment is 35.1 °C (95.2 °F): After the device is switched off, the air temperature in the patient compartment falls by 1.4 °C (2.5 °F) after 10 minutes.

– The set air temperature in the patient compartment is 35.1 °C (95.2 °F): After the device is switched off, the air temperature in the patient compartment falls by 2.0 °C (3.6 °F) after 20 minutes.

Carry out the following preparations to prevent loss of heat during intrahospital patient transfer with the warming therapy switched off:

– 15 minutes before the device is switched off, increase the target value for the air temperature in the patient compartment by 1.0 to 1.5 °C (1.7 to 2.7 °F). The device will be preheated accordingly.

– Preheat the heated mattress.

– Keep the patient in a positioning aid and cover with a blanket.

– Lay external heat cushions in the device.

– Place the hood cover on the device.

The device must be set to a low height prior to moving the patient so that the red hatched label on the lifting column is no longer visible. At this height, the device can be moved without the radiant warmer hitting a door frame, for example.


Transfer

Fig. 8 Label on the lifting column

7.1.2 Transferring the patient

This chapter describes how to prepare the device for transfer and how to transfer the patient together with the device.

Prerequisites:

– The device is in operation.

– The device height adjustment mechanism is not locked.

– An external temperature sensor for measuring body core temperature is at hand.

– The patient’s state of health is suitable for intrahospital transfer.

– The user bears the responsibility for intrahospital patient transfer.

WARNINGRisk of patient injury due to interruption of warming therapyWhen the patient is moved to another room in the device, the device is switched off during the transfer. The warming therapy is interrupted and the skin temperature is not measured.

During the transfer, monitor the patient's body core temperature with a separate measuring device.

Make sure that the patient is sufficiently warmed during the transfer.

WARNINGRisk of patient injury during transferDevice parts may be damaged during transfer. The device may tip over. The patient may be injured and device functions may be impaired. Before transfer, perform the following measures:

Set the device to transfer height and observe the information in the chapter "Transferring the patient".

Make sure that there is always sufficient clearance above the radiant warmer and that the radiant warmer is not damaged.

Make sure that accessories, e.g., pressure reducers and cylinder valves, do not protrude beyond the trolley during the transfer.

When transferring the patient, the device must always be moved by two people.

Avoid shocks and vibrations as much as possible, e.g., when crossing door thresholds and passing through door frames.

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Transfer

Check the functional integrity of the accessories during and after the intrahospital transport. Observe the chapter Adjusting the device height.

The following restrictions apply during intrahospital patient transfer within the building:

– The warming therapy is deactivated.

– During intrahospital transfer, the patient is not actively supplied with heat, humidified air, or oxygen.

– The body core temperature of the patient must be monitored with an external temperature sensor.

– The patient’s state of health must be suitable for intrahospital transfer.Babyleo TN500 is not a transport incubator. The user bears the responsibility for intrahospital patient transfer.

Procedure:

1. Adjust the height of the device using the foot pedals. The correct transfer height is reached when the red hatched label on the lifting column is completely covered.

The correct device height for transfer is set.

Fig. 9 Setting the transfer height

2. Carefully fold additional devices on the mounted support arms, e.g., patient monitors or syringe pumps, against the device.

3. Secure loose objects on mounted support arms to prevent them from falling down.

4. Close the hood.

5. Remove the x-ray cassette from the x-ray tray. Slide the x-ray tray into the device.

6. Slide the bed support into the device.

7. Slide the drawer into the device and lock the drawer.

8. Check if the patient can be moved without warming therapy.

If the patient's state of health is stable enough, the patient can be moved in the device.

9. Fasten an external temperature sensor to the patient to measure the body core temperature.

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Transfer

10.Switch off the device on the display unit using the Start/standby key .

The dialog window Shut down will be displayed.

11.Touch the Shut down button and confirm.

The device functions are shut down.

12.Switch off the device using the main switch on the rear of the main column.

13.Remove all plugs and the mains plug. Fasten the power cable to the device.

The device is ready for transfer.

Check the operational readiness after the transfer.


Troubleshooting

8 Troubleshooting

8.1 Alarm – Cause – Remedy

The priority of the following alarm message has been changed from low to medium.

8.2 Fault during weighing

The following texts replace the chapter Faults during weighing in the instructions for use.

The weight of the patient cannot be determined.

Weight is too high.

Priority Alarm Cause Remedy

!! 16 Water level low The water level of the humid-ification system is low.

Make sure that the water supply is correctly connected.

Refill the water supply.

Condition Cause Remedy

The following text is dis-played while the scale is being zeroed or the patient is being weighed: Weight value invalid. Check scale.

The weight for zeroing or the weight of the patient could not be determined. There is a problem with the scale.

Check the position of the mattress tray and the mat-tress on the scale. Check that the scale plug is cor-rectly plugged in. Repeat the weighing process. If weighing is still not possi-ble, contact specialized service personnel.

Condition Cause Remedy

The following text is dis-played during the weigh-ing process: Maximum weight exceeded. The weight cannot be deter-mined.

There is too much weight on the scale.

Check the scale. Check that the mattress tray and mattress are correctly positioned on the scale. Take all unnecessary items off the mattress tray. Repeat the weighing pro-cess. If weighing is still not possible, contact special-ized service personnel.


Troubleshooting

Other faults during weighing:

Text Cause Remedy

Zeroing failed. The weight for zeroing could not be determined. The patient has not been lifted. The scale was not set to zero.

Set the scale to zero again.

Load is too high for zeroing.

The permissible weight for zeroing has been exceeded.

Set the scale to zero again and only lift the patient.

Weighing canceled. The weight of the patient could not be determined.

Repeat the weighing pro-cess. If weighing is still not possible, contact special-ized service personnel.

Weighing failed. The weight of the patient could not be determined.

Repeat the weighing pro-cess. If weighing is still not possible, contact special-ized service personnel.


Reprocessing

9 Reprocessing

The following chapters have been changed or added.

9.1 Information on reprocessing

Follow the national infection prevention policies and reprocessing regulations. Follow the infection prevention policies and reprocessing regulations of the health-care facility (e.g., concerning the reprocessing cycles).

9.2 Classifications for reprocessing

9.2.1 Classification of medical devices

Medical devices and their components are classified according to the way they are used and the resulting risk.

9.2.2 Classification of device-specific components

The entire device must be reprocessed. Observe the following classification and the instructions for use for the components.

9.3 Validated reprocessing procedures

At the time of validation, the following reprocessing procedures showed good material compatibility and effectiveness:

Classification Definition

Non-critical Components that come into contact with intact skin only

Semi-critical Components that carry breathing gas or come into con-tact with mucous membranes or pathologically altered skin

Critical Components that penetrate skin or mucous membranes or come into contact with blood

Classification Device-specific components

Non-critical The entire device and all components that can be dis-mantled

Semi-critical -

Critical -


Reprocessing

9.3.1 Surface disinfection with cleaning

This chapter describes surface disinfection with cleaning for the entire device and for all components. Surface disinfection using the following surface disinfectant is suitable for the device and all components:

Validated reprocessing procedure

Prerequisite:

– The surface disinfectant was prepared immediately before cleaning according to the manufacturer's instructions.

WARNINGRisk due to penetrating liquidPenetrating liquid may cause the following:– Damage to the device– Electrical shock when switching on the device– Device malfunctions

Make sure that no liquid penetrates into the device.

WARNINGRisk of O2 sensor malfunctionDisinfectants or cleaning agents which contain formaldehyde or ammonia may damage the O2 sensors. The O2 sensors may provide incorrect measured values. This may put the patient at risk.

Only use disinfectants or cleaning agents which do not contain formaldehyde or ammonia.

Surface disinfectants containing alcohol are not suitable for reprocessing Babyleo TN500.

Cleaning

1. Dip the low-germ, lint-free cloth into the surface disinfectant. Squeeze out the cloth.

2. Wipe all surfaces at least 3 times. Check that all visible soiling has been removed. If necessary, repeat the cleaning.

Surface disinfection

1. Dip the low-germ, lint-free cloth into the surface disinfectant. Squeeze out the cloth.

2. Wipe all surfaces at least 3 times. Make sure that the surfaces are fully moistened.

3. Observe the contact time.

4. Moisten a new low-germ, lint-free cloth with water (at least drinking water quality).

5. Wipe all surfaces until no remains of the surface disinfectant are visible. There must be no more foam residues or streaks.

Class of active ingredient

Product name Manufacturer Contact time

Concentra-tion

Oxygen-releasing agents

Dismozon plus BODE Chemie 15 min 1.6 %


Reprocessing

6. Allow the product to dry.

7. Check the product for visible damage and replace if necessary.

Supplementary information

Surface disinfection with cleaning of the following parts requires special attention:

– Hood and hood seal

– Air ducts of the X-ray flap

1. Wipe the inside and outside of the hood.

2. When treating the hood seal, make sure the disinfectant also comes into contact with the inner part of the hood seal.

3. To clean the air ducts of the X-ray flap (1), pull a cloth soaked with surface disinfectant through each air duct.

Fig. 10 Air ducts of the X-ray flap

9.3.2 Machine cleaning with thermal disinfection

Machine reprocessing is suitable only for the fan impeller and the hose grommets. The fan impeller and the hose grommets can be machine cleaned and disinfected. Machine reprocessing can be carried out in addition to or as an alternative to surface disinfection. Use a washer-disinfector which meets the requirements of ISO 15883. Follow the instructions for use for the washer-disinfector.

Validated reprocessing procedure

Prerequisite:

– The washer-disinfector has been prepared according to the manufacturer's instructions.

30

23

1

1

Process step Product name Manufacturer Contact time

Temperature

Machine cleaning

Neodisher MediClean forte

Chemische Fabrik Dr. Wei-gert

At least 10 min

55 °C (131 °F)

Machine dis-infection (thermal)

- -At least 5 minutes

90 °C (194 °F)


Reprocessing

Procedure:

1. Securely position the product in the basket. Ensure the following:

– All surfaces and interior spaces can be flushed completely.

– The water can drain off freely.

2. Start the machine cleaning with thermal disinfection.

3. Use demineralized water for the final rinsing.

4. After the cycle has ended, check the product for visible soiling. If required, repeat the cycle or carry out a surface disinfection with cleaning.

5. Check the product for visible damage and replace it if necessary.

9.4 Other agents and reprocessing procedures

Use disinfectants that are nationally approved and suitable for the particular reprocessing procedure.

9.4.1 Surface disinfectant

The surface disinfectants listed in the following table can be used in addition to the surface disinfectants listed in the section "Validated reprocessing procedures".

The manufacturers of the surface disinfectants have verified at least the following spectra of activity:

– Bactericidal

– Yeasticidal

– Virucidal or virucidal against enveloped viruses

Follow the manufacturer's instructions for surface disinfectants.

The following surface disinfectants were compatible with the material at the time of testing:


Surface disinfectant Manufacturer Listing

Chlorine-releas-ing agents

BruTab 6S Brulin EPA1)

Clorox Professional Dis-infecting Bleach Cleaner

Clorox EPA

Dispatch Hospital Cleaner Disinfectant Towels with Bleach

Clorox EPA

Klorsept 17 Medentech EPA

Oxygen-releasing agents

Descogen Liquid Antiseptica CE

Descogen Liquid r.f.u. Antiseptica CE

Oxygenon Liquid r.f.u. Antiseptica CE

Dismozon plus BODE Chemie CE

Dismozon pur2) BODE Chemie CE

Oxycide Ecolab USA EPA

Perform Schülke & Mayr CE

SteriMax Wipes Maxi Aseptix CE


Reprocessing

Dräger states that oxygen-releasing agents and chlorine-releasing agents may cause color change in some materials. Color change does not indicate that the product is not functioning correctly.

Other surface disinfectants are used at one's own risk.

9.5 Storage and transport

After reprocessing, there are no special requirements for the storage and transport of the product. All other information in the instructions for use regarding storage and transport continues to apply. In addition, the requirements that prevent contamination or damage to the product must be met. These include, for example, dry and dust-free storage and avoiding damage during transport to the operating location.

Quaternary ammonium com-pounds

Mikrozid sensitive liquid3) Schülke & Mayr CE

Mikrozid sensitive

wipes3)Schülke & Mayr CE

Mikrozid alcohol free liq-

uid3)Schülke & Mayr CE

Mikrozid alcohol free

wipes3)Schülke & Mayr CE

acryl-des3) Schülke & Mayr CE

Cleanisept Wipes Maxi Dr. Schumacher CE

Surfa'Safe Premium ANIOS Laborato-ries

CE

Wip'Anios Excel ANIOS Laborato-ries

CE

Tuffie 5 Vernacare ARTG4)

1) United States Environmental Protection Agency2) Discontinued by the manufacturer3) Virucidal against enveloped viruses4) Australian Register of Therapeutic Goods


Surface disinfectant Manufacturer Listing


Service

10 Service


10.1 Inspection

The texts for the scale have been changed.

10.1.1 Remote Service

The following chapter has been added.

10.1.1.1 Reading out the logbook entries

Prerequisites:

– There is no patient in the device.

– The device is in operation.

WARNINGRisk of patient injury due to service measures performed during therapyPerforming service measures during therapy may endanger the patient.

Only perform service measures when there is no patient in the device.

Procedure:

1. Connect the USB mass storage device to the USB port on the rear of the main column.

2. Touch the System setup... button in the main menu bar.

3. In the System setup dialog window, open the System > Service screen.

4. Enter and confirm the configuration password.

5. Touch the Service menu button and confirm.

6. Open the Service Call > Help Ticket screen.

7. Touch the Send Data button.

Wait until the following messages are displayed: Finished DSR generation and Success.

If an error message is displayed, disconnect the USB mass storage device and plug it in again.

8. Disconnect the USB mass storage device.

9. Send the file to DrägerService.

Measure Interval Target group

Check the measurement accu-racy of the scale

Every 12 months Service personnel

Verifying the scale According to regulatory requirements for scales

which must be verified1)

1) Both according to regulatory requirements, such as prescribed intervals, and, for example, after repair and adjustment of the scale.

Officially authorized specialist personnel


Service

10.1.2 Verification of the NAWI scale (option)

This chapter has been omitted.

10.1.3 Safety checks

10.1.3.1 Performing the safety checks

7.) The following sentence has been deleted:

– Check of the incubator temperature according to standard IEC 60601-2-19, sentence 201.12.1.105

8.) The following section has been changed:

– Check the accuracy of the incubator temperature:


– Check the accuracy of the skin temperature measurement:

Simulation resistors are connected instead of the skin temperature sensors.

10.1.4 Metrological checks

10.1.4.1 Skin temperature measurement


– The displayed measured temperature value must not deviate from the temperature value simulated by the relevant resistance by more than 0.2 °C (0.36 °F).

Set value 36.0 °C (96.8 °F)

Accuracy ±0.8 °C (±1.44 °F)

Accuracy of reference thermometer ± 0.05 °C (±0.09 °F)

Simulation resistance 1412 Ω

Set value 36.0 °C (96.8 °F)

Accuracy ±0.2 °C (±0.36 °F)


Technical data

11 Technical data


11.1 Operating characteristics

11.1.1 Measured value displays

11.2 EMC declaration

The following text and data replace the EMC Declaration chapter in the instructions for use:

11.2.1 General information

This device was tested for electromagnetic compatibility using accessories from the list of accessories. Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use of non-compliant accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.

This device may be used in the direct vicinity of other devices only if Dräger has approved this device arrangement. If no approval has been given by Dräger, it must be ensured that this device functions correctly in the desired arrangement before use. The instructions for use for the other devices must be followed.

11.2.2 Electromagnetic environment

This device may only be used in environments specified in the "Environments of use" section.

The emissions characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11, class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Scale

Measuring range (including the weight for zeroing)

200 to 10000 g (0.44 to 22 lb)

Display range 0 to 10090 g (0 to 22.2 lb)

Measurement uncertainty 0 to 5000 g (0 to 11 lb): 5 g (0.2 oz)for loads over 5000 g (11 to 22 lb): 10 g (0.4 oz)

Weight for zeroing ≤ 10 kg (22 lb)

Resolution (NAWI version) 10 g

Resolution (standard version) 1 g (1 oz)

Emissions Compliance

Radiated emissions Class A, group 1 (30 MHz bis 1 GHz)

Conducted emissions Class A, group 1 (150 kHz to 30 MHz)


Technical data

11.2.3 Recommended separation distances from wireless communication devices

To ensure that the full functional integrity of this device is not compromised, there must be a separation distance of at least 1.0 m (3.3 ft) between this device and radio communications devices.

Immunity against Test level and required electromag-netic environment

Electrostatic discharge (ESD) (IEC 61000-4-2)

Contact discharge: ±8 kV

Air discharge: ±15 kV

Fast transient electrical disturbances (bursts) (IEC 61000-4-4)

Power cable: ± 2 kV

Longer signal input lines/output lines: ±1 kV

Impulse voltages (surges) (IEC 61000-4-5)

Voltage, external conductor – external conductor: ±1 kV

Voltage, external conductor – protective ground conductor: ± 2 kV

Magnetic fields at mains frequency (IEC 61000-4-8)

50 Hz: 30 A/m

Voltage dips and short interruptions in the supply voltage (IEC 61000-4-11)

Voltage dips of 30 % to 100 %, 8.3 ms to 5 s, different phase angles

Radiated high-frequency disturbances (IEC 61000-4-3)

80 MHz to 2.7 GHz: 3 V/m

Conducted high-frequency distur-bances (IEC 61000-4-6)

150 kHz to 80 MHz: 3 V, ISM bands: 6 V

Electromagnetic fields in the vicinity of wireless communication devices

Various frequencies from 385 MHz to 5785 MHz: 9 V/m to 28 V/m


Annex

12 Annex

12.1 Delay of the alarm condition

The duration of the alarm delay has been changed for the following alarm message:

Alarm Duration of alarm delay

Water level low 3 min

Á9056310#È

Manufacturer

Drägerwerk AG & Co. KGaAMoislinger Allee 53 – 5523542 LübeckGermany+49 451 8 82-0

FAX +49 451 8 82-2080http://www.draeger.com

9056310 – en© Drägerwerk AG & Co. KGaA Edition: 3 – 2019-04 Dräger reserves the right to make modifications to the medical device without prior notice.

supplement babyleo tn500 · 2020-05-05 · supplement | babyleo tn500 sw 1.0n 7 operation 5...

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