Babyleo TN500 Instructions for Use sw 1.0n Edition 2 Aug 2018

This page has been left blank intentionally.

2

Instructions for use Babyleo TN500 SW 1.0n

Contents

Contents 1

2

3

4

5

Information about this document ...

6

1.1 1.2 1.3 1.4

Typographical conventions ... Use of terms ... Illustrations... Trademarks...

6 6 6 7

Safety-related information ...

8

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16

Intended use ... Indications... Contraindications ... Environments of use ... Essential performance characteristics ... Target groups ... Information on safety instructions and precautionary statements... Basic safety instructions ... Electrical safety... Use of oxygen... Explosion protection ... Mechanical safety ... Thermal radiation and fire prevention ... Therapy and applications... Safety during cleaning and service... Safety instructions for accessories ...

8 8 8 8 9 9 10 11 13 14 15 15 18 19 22 23

Product description ...

24

3.1 3.2 3.3

Structure and function... Screen views ... Range of functions...

24 32 41

Operating concept ...

45

4.1 4.2 4.3 4.4 4.5 4.6

Display unit ... Adjusting the device height... Adjusting the mattress tray ... Hood ... Hand ports and access panels ... Locking and unlocking functions...

45 48 49 51 52 55

Assembly and preparation ...

56

5.1 5.2 5.3

56 57

5.4 5.5

Maximum load ... Nurse call... Adjusting the gas cylinder holder and connecting the oxygen cylinder Establishing potential equalization... MEDIBUS connection for data transfer...

Instructions for use Babyleo TN500 SW 1.0n

58 62 62

3

Contents

6

7

8

9

Operation ...

63

6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 6.14 6.15 6.16 6.17 6.18 6.19 6.20

Checking for operational readiness ... Switching on the device ... Switching off the device ... Operating modes ... Incubator operation... Radiant warmer operation ... Transition ... Skin temperature mode ... Air temperature mode ... Manual mode ... Humidity... Oxygen (option) ... Heated mattress (option) ... Kangaroo mode ... Tolerate cooling (option) ... Warm-up (option)... Weaning (option) ... Scale (option)... Taking x-rays ... Developmental care (option)...

63 64 67 68 69 71 74 77 85 91 94 96 100 104 109 111 113 116 122 124

Alarms...

127

7.1 7.2 7.3 7.4

Alarm priorities and alarm signals... Suppressing and delaying the alarm signal ... Dismissing the alarm message... Viewing the alarm history...

127 127 130 130

Configuration ...

131

8.1 8.2 8.3 8.4

131 134 137 142

Transfer...

150

9.1

Intrahospital patient transfer with switched off warming therapy ...

150

10 Troubleshooting...

153

10.1 10.2 10.3 10.4 10.5 10.6 10.7

Alarm – Cause – Remedy... Power failure alarm... Adjustment of device height not possible ... Adjustment of mattress tray not possible... Fault during weighing... Fault with the oxygen supply ... Removing liquid from the heating plate ...

153 161 162 162 162 163 164

11 Reprocessing ...

166

11.1 11.2 11.3

4

Entering patient data... Transferring data to another device... Displaying trends and data ... System setup ...

Automatic humidifier cleaning... Dismantling ... Information on reprocessing ...

166 167 171

Instructions for use Babyleo TN500 SW 1.0n

Contents

11.4 11.5 11.6 11.7 11.8

Classification for reprocessing... Recommendations for reprocessing ... Surface disinfection with cleaning... Additional reprocessing measures... After reprocessing...

172 172 174 176 176

12 Service ...

180

12.1 12.2 12.3 12.4 12.5 12.6

Overview... Inspection ... Maintenance ... Replacing the filter cloth for patient air in the sensor wall... Repair ... Activating applications ...

180 180 184 185 185 185

13 Disposal ...

187

13.1

Disposing of the device...

187

14 Technical data ...

188

14.1 Ambient conditions ... 14.2 Operating data ... 14.3 Performance characteristics ... 14.4 Measured value display ... 14.5 Materials ... 14.6 Data exchange and interfaces ... 14.7 Device combinations... 14.8 Connections to IT networks ... 14.9 EMC Declaration... 14.10 Open-source software ...

188 188 189 190 192 192 194 194 196 199

15 Annex ...

200

15.1 Description of skin temperature regulation ... 15.2 Further information on heated mattress (option) ... 15.3 Automatic selftest ... 15.4 Delay of the alarm condition ... 15.5 Schematic representation of alarm and information tones ... 15.6 Interfaces ... 15.7 Abbreviations ... 15.8 Symbols ... 15.9 Symbol in the software ... 15.10 Product labels ...

200 201 202 203 203 204 205 206 209 210

16 Password ...

213

16.1

Configuration password for Babyleo TN500 Software 1.0n...

213

Index...

215

Instructions for use Babyleo TN500 SW 1.0n

5

Information about this document

1

Information about this document

1.1

Typographical conventions Text

Texts printed in bold and italics indicate device labels and screen texts.

1

Numbers indicate the individual action steps of a sequence of actions. The numbering restarts with 1 for each new sequence of actions.

(1)

Numbers in parentheses refer to elements in illustrations.

1

Numbers in illustrations are shown within a circle and indicate elements to which reference is made in the text.

►

This triangle is used in safety instructions and precautionary statements to indicate possible ways of avoiding the risk.

–

Dashes indicate lists.

>

The "greater than" symbol indicates the navigation path in a dialog window. This symbol indicates information which makes it easier to use the product.

1.2



This arrow indicates the result of a process step.

✓

This check mark indicates the result of a process sequence.

Use of terms Dräger uses the term "accessory" not only for accessories in the sense of IEC 60601-1, but also for consumable parts, removable parts and attached parts.

1.3

Illustrations Depending on the configuration, the products and screen content shown in this document may differ from the actual on-site products.

6

Instructions for use Babyleo TN500 SW 1.0n

Information about this document

1.4

Trademarks Trademarks owned by Dräger The trademarks are registered in the following countries: Trademark Babyleo®

Country Germany, Australia, Switzerland, China, EU, Japan, Korea, Mexico, New Zealand, Russia, Singapore, USA

Infinity®

EU, USA, China, Brazil, Australia, India

IncuWarmer®

EU

DrägerService®

Germany, USA

®

MEDIBUS.X

EU, USA

Oxycell®

EU, USA

KangarooMode®

EU, USA

ThermoMonitoring®

Germany, France, USA

Trademarks owned by third-party manufacturers Trademark

Trademark owner

Actichlor®

Ecolab

Incidin®

Ecolab ®

BruTab6S

Brulin

®

Buraton

Schülke & Mayr

Mikrozid®

Schülke & Mayr

Perform®

Schülke & Mayr

acryl-des®

Schülke & Mayr

Descogen®

Antiseptica

Dismozon®

BODE Chemie

Dispatch®

Clorox

®

Medentech

Oxycide®

Ecolab USA

Virkon®

DuPont

Neodisher®

Chemische Fabrik Dr. Weigert

ODU MEDI-SNAP®

ODU

Klorsept

Instructions for use Babyleo TN500 SW 1.0n

7

Safety-related information

2

Safety-related information

2.1

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.

2.2

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)

2.3

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

2.4

Environments of use 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 intended for use in the following environments where some of the functions described under intended use are restricted (no active warming therapy, humidification, and oxygen enrichment). For further information, see the following chapter: ''Intrahospital patient transfer with switched off warming therapy'' (page 150) – During intrahospital patient transfer Babyleo TN500 is not intended for use in the following environments: – Home use – Transport vehicles, e.g., ambulances, airplanes, or helicopters – MRI environment

8

Instructions for use Babyleo TN500 SW 1.0n

Safety-related information

2.5

Essential performance characteristics Provided that the essential performance characteristics are functioning correctly, the product can be used for its intended purpose. The product has the following essential performance characteristics: – Skin temperature regulation in incubator operation The measured central skin temperature is compared with the set value for the skin temperature and adjusted accordingly, or an alarm is triggered. – Air temperature regulation in incubator operation The measured air temperature in the patient compartment is compared with the set value for the air temperature and adjusted accordingly, or an alarm is triggered. – Skin temperature regulation in radiant warmer operation The measured central skin temperature is compared with the set value for the skin temperature and adjusted accordingly, or an alarm is triggered.

2.6

Target groups

2.6.1

Definition of target groups The target groups may only carry out the following activities if they meet the necessary requirements. For further information, see the following chapter: ''Basic safety instructions'' (page 11)

2.6.1.1

Users Users are clinical personnel such as doctors and nursing staff trained in neonatology. Activity Requirement Use of the product in accordance with Specialist medical knowledge in neonatolthe intended use ogy Knowledge of currently known risks and benefits of warming therapy

2.6.1.2

Reprocessing personnel Activity Reprocessing

2.6.1.3

Requirement Specialist knowledge in the reprocessing of medical devices

Service personnel Service personnel are, e.g., hospital technicians trained in servicing the device. Activity Requirement Installation Specialist knowledge in electrical engineering and mechanics Basic service work (inspection, mainExperience in the servicing of medical tenance according to the "Maintedevices nance" chapter)

Instructions for use Babyleo TN500 SW 1.0n

9

Safety-related information

2.6.1.4

Specialized service personnel Activity Installation Basic and complex service work (inspection, maintenance, repair)

Requirement Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices Experience in complex service work on this product

Dräger recommends arranging a service contract with DrägerService. 2.6.1.5

Installation personnel Installation personnel are, e.g., hospital technicians who have not received training for this device. Activity Assembly and installation

2.7

Requirement Specialist knowledge in electrical engineering and mechanics Experience in the assembly and installation of medical devices

Information on safety instructions and precautionary statements Safety instructions and precautionary statements warn of risks and give instructions for the safe use of the product. Failure to observe them may lead to personal injury or property damage.

2.7.1

Safety instructions This document contains sections with safety instructions which warn of risks. The type of risk and the consequences of non-compliance are described in each safety instruction.

2.7.2

Precautionary statements Precautionary statements relate to action steps and warn of risks that may arise when executing the action steps. Precautionary statements precede the action steps. The following warning signs and signal words indicate precautionary statements and differentiate the possible consequences of non-compliance. Warning sign Signal word WARNING

10

Consequences of non-compliance May result in death or serious injury.

CAUTION

May result in moderate or minor injury.

NOTICE

May result in property damage.

Instructions for use Babyleo TN500 SW 1.0n

Safety-related information

2.8

Basic safety instructions

2.8.1

Instructions for use Failure to use the product in accordance with the information contained in these instructions for use may result in personal injury and property damage. ► Follow these instructions for use and those for any products used in conjunction with this product. ► Only use this product for the purpose specified in ''Intended use''. ► Keep these instructions for use close to hand. The instructions for use do not contain any information on the following points: – Risks that are obvious to users – Consequences of obvious improper use of the product – Potentially negative effects on patients with different underlying diseases

2.8.2

Symbols and product labels Failure to observe symbols and product labels may result in personal injury and property damage. ► Observe the symbols and product labels.

2.8.3

Monitoring the patient's condition Monitoring of a patient's condition can range from direct observation to electronic monitoring by means of medical devices. The patient may be put at risk if his or her condition is not adequately monitored. ► Monitor the patient's condition by suitable means and at appropriate intervals.

2.8.4

Duties of the operating organization The tasks described in this document specify the requirements which have to be met by each respective target group. If the respective target group is not appropriately qualified, personal injury and property damage may result. The operating organization of this product must ensure the following: ► The target group has the required qualifications (e.g., has undergone specialist training or acquired specialist knowledge through experience) ► The target group has been trained to perform the task. ► The target group has read the sections of these instructions for use relating to the activity concerned and noted the safety instructions and precautionary statements they contain.

Instructions for use Babyleo TN500 SW 1.0n

11

Safety-related information

2.8.5

Operation of the device by persons outside the defined target groups The device is not intended for use by non-specialists (persons not defined as target group). Responsibility for use of the device that is inconsistent with its intended use, particularly by non-specialists, lies with the operating organization. If the operating organization nevertheless allows non-specialists to interact with the device, appropriate instruction and supervision must be provided. If non-specialists (e.g., visitors) are given access to the device, the following precautions must be taken: ► Non-specialists must be informed that unauthorized interactions may lead to injury. ► Select the Family screen view or lock the user interface to prevent device settings from being changed unintentionally. ► Lock the height adjustment and the bed-tilt mechanism to prevent them from being activated unintentionally.

2.8.6

Modifications to the product Modifications to the product may lead to malfunctions, which in turn may result in personal injury and property damage. ► Do not modify this product.

2.8.7

Alarms Failure to notice alarm signals may put the patient at risk. ► Check that 2 acoustic signals sound and the alarm light shows yellow and red when the device is switched on. ► Set the alarm volume so that alarm signals can be heard. ► Be aware that only high- and medium-priority alarms trigger the nurse call. ► Take note of alarms directly on the device. Be aware that using the nurse call does not unconditionally guarantee that alarms will be transmitted. ► Make sure that the alarm system has not been rendered ineffective by setting the alarm limits to extreme values or deactivated by switching off the alarms. ► Adjust the basic alarm settings on devices to the needs of the patient.

2.8.8

Service port Only use the service port on the device for servicing purposes. Any other use may lead to malfunctions, which in turn may result in personal injury. ► Do not use the service port (RJ45) to connect the device to the IT network.

12

Instructions for use Babyleo TN500 SW 1.0n

Safety-related information

2.9

Electrical safety

2.9.1

Electric shock Under the housing there are conducting components which may cause an electric shock. To avoid the risk of personal injury and property damage, the following preventive measures must be taken: ► The housing must only be opened by the target groups authorized to perform the respective service measure. ► Disconnect the mains plug before opening the housing. ► Do not simultaneously touch the connectors of the interfaces and the patient. ► To prevent condensate formation and the resulting failure of electronic components, do not switch on the device for 3 hours after sudden temperature changes (e.g., after storage in unheated rooms). ► Only connect the device to grounded power sockets. ► Do not connect the device by means of a power socket strip. ► Only connect USB mass storage devices that are included in the list of approved accessories to the USB port. ► Do not connect any accessory operating on mains voltage to the USB port. ► Only connect devices to the audio port, COM port, USB port and service port that comply with the requirements set out in the standards and specifications listed in the technical data. For further information, see the following chapter: ''Technical data'' (page 188). ► Do not place containers containing more than 1 liter of liquid in or on the device. ► Do not allow any liquids to penetrate into the device.

2.9.2

Electromagnetic compatibility (EMC) Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. The EMC information must be observed during installation and commissioning. For further information, see the following section: ''EMC Declaration'' (page 196). Portable and mobile radio frequency communication equipment can affect medical electrical equipment. To avoid the risk of malfunctions, the following measures must be taken and the personnel concerned must be trained accordingly: ► Observe the ESD protective measures. Such protective measures may include wearing antistatic clothing and shoes, touching a potential equalization pin before and during connection of the pins, or using electrically insulating and antistatic gloves. ► Comply with the requirements for an electromagnetic environment. For further information, see the following chapter: ''Electromagnetic environment'' (page 197).

Instructions for use Babyleo TN500 SW 1.0n

13

Safety-related information

Electromagnetic fields may disrupt the function of the device, putting the patient at risk. Electromagnetic fields are generated by, for example: – Cellular phones – Radio-frequency surgical equipment – Defibrillators – Shortwave therapy equipment ► Observe the separation distances. For further information, see the following chapter: ''Recommended safety clearances for portable and mobile highfrequency communication equipment'' (page 199).

2.10

Use of oxygen

2.10.1

Oxygen cylinders If oxygen cylinders or devices containing oxygen are installed in the vicinity of the ventilation slot, oxygen may get into the device at the power supply unit. In the event of sparking at the power supply unit there is an increased risk of fire, which may lead to personal injury and property damage. ► Position oxygen cylinders and devices containing oxygen on that side of the device without the ventilation slot.

2.10.2

Oxygen cylinder valves The use of unauthorized or poorly maintained oxygen cylinder valves presents an increased risk of fire, which may lead to personal injury and property damage. ► Do not use unauthorized oxygen cylinder valves. ► Make sure that oxygen connectors and oxygen seals are kept free from oil and dust at all times. Always open oxygen cylinder valves slowly.

2.10.3

Oxygen supply The health of patients can be endangered if they are provided with too much or not enough oxygen. If O2 is supplied externally, there is also a risk of fire. ► If the device is switched off, do not supply any O2 from an external source. Do not leave behind any oxygen-supplying accessories (e.g., O2 hood, nasal prongs) in the patient compartment. ► Measure and monitor the oxygen concentration in the patient compartment. ► Make sure that the oxygen concentration in the patient compartment is always below 65 %. ► Always monitor the oxygen concentration in the patient's blood, e.g., using blood gas analysis and a pulse oxymeter. ► Make sure that the O2 settings are correct. ► Check the amount of O2 supplied via an external O2 hood. ► Always monitor the additional O2 supply via the central gas supply, an oxygen cylinder or an O2 hood. ► Be aware that Babyleo TN500 displays no alarms in the case of an external oxygen supply, e.g., via an O2 hood. ► In the patient compartment use only electrical devices that are approved for use in an oxygen-enriched atmosphere.

14

Instructions for use Babyleo TN500 SW 1.0n

Safety-related information

2.10.4

Oxygen sensors The air in the patient compartment can be enriched with oxygen (option). The oxygen concentration in the patient compartment is measured by O2 sensors. The user must adjust the O2 sensors regularly. If the O2 sensors are not adjusted, the measurement uncertainty of the oxygen concentration may be increased. The patient may then receive too much or too little oxygen. The health of the patient may be endangered. ► Always monitor the oxygen concentration in the patient's blood, e.g., using blood gas analysis and a pulse oxymeter. ► Adjust the O2 sensors at least every 2 weeks under Special procedures... > Oxygen. ► Measure and monitor the oxygen concentration in the patient compartment.

2.11

Explosion protection

2.11.1

Flammable gases In the presence of oxygen concentrations greater than 25 Vol%, combustible or explosive gas mixtures, there is an increased risk of explosion and fire, which may lead to personal injury and property damage. ► Do not operate the device in areas where oxygen concentrations greater than 25 Vol%, combustible or explosive gas mixtures are likely to occur. ► Do not operate the device in areas where combustible solvents or explosive anesthetic agents are used. ► Do not use combustible solvents or explosive anesthetic agents in the device. Even small residues of these agents may react with oxygen to cause a fire.

2.11.2

Unauthorized gases The use of compressed gases that are not approved for medical purposes may adversely affect the function of the device and put the patient's health at risk. ► Only use compressed gases that are approved for medical purposes. ► Only use compressed gases that are dry and free from dust and oil.

2.12

Mechanical safety

2.12.1

Tipping over of the device Excessive weight loading or a change in the center of gravity may cause the device to tip over, injuring the patient, users, and bystanders. The device and accessories may also be damaged due to the tip over. ► Do not place the device on inclined surfaces and avoid lateral loading by pushing, resting, or leaning against the side. ► Observe the maximum load for all shelves, drawers, and holding devices. ► Do not exceed the maximum load of the x-ray tray. ► During transfer make sure that the device does not tip over due to incorrect alignment of accessories on the duct rail.

Instructions for use Babyleo TN500 SW 1.0n

15

Safety-related information

2.12.2

Trapping of body parts

28227

The careless execution of functions or the accidental triggering of functions by untrained persons may cause injury to the patient, users or third parties. Hands, feet, and other body parts may become trapped and crushed. There is also a risk of injury from incorrectly mounted accessories. The illustration below shows the special hazard areas.

1

2 3 4

10

5

9

6 7 8

Fig. 1

Special hazard areas during operation

No. Location where there is a risk of injury 1 Between the hood arm and the housing of the radiant warmer and between the hood frame and the front of the radiant warmer (e.g., when opening and closing the hood) 2 On the accessories of the side duct rails when closing the hood or lowering the hood arm 3 Between the hood and the side panels (especially on the sensor wall) 4 On the sensor wall between the bed support and the inside of the device (e.g., when lowering or tilting the mattress tray) 5 On the long side of the bed support between the mattress tray and the inside of the device (e.g., when lowering or tilting the mattress tray) 6 Between the compressed gas cylinder and accessories fixed to the duct rail (e.g., when lowering the device) 7 Between the trolley and the power cable connection (e.g., when lowering the device) 8 Between the trolley and the drawer (e.g., when lowering the device)

16

Instructions for use Babyleo TN500 SW 1.0n

Safety-related information

No. Location where there is a risk of injury 9 On the front between the bed support and the inside of the device (e.g., when lowering or tilting the mattress tray) 10 When closing the hand ports, when closing one of the two side access panels or the front access panel. Before moving device components, take the following precautions: ► Make sure that there is no-one else in the hazard area. ► Make sure that no body parts become trapped.

2.12.3

Risk of patient falling out If the access panels or the hand ports are open or the mattress tray has been pulled out, there is a risk of the patient falling out. ► Make sure that the side and front access panels are correctly locked. ► Monitor the patient at all times when the access panels or hand ports are open or the mattress tray is pulled out.

2.12.4

Unintended movement of the trolley If the locking brakes are not engaged, the trolley may move on inclined surfaces, causing injury to the patient and bystanders. ► In stationary operation, engage all the locking brakes on the trolley and check that they are working properly.

2.12.5

Falling objects Objects placed on the hood may fall off, injuring the patient. ► Remove all objects before opening the hood.

2.12.6

Wear and material fatigue Wear and material fatigue on the components may lead to device malfunctions and other faults. There is a risk of injury. ► Check the device and reusable products for signs of wear (e.g., cracks, deformation, discoloration, or detachment) and replace if necessary. ► Perform service measures at the specified intervals. ► Replace the fan impeller when damaged. ► Check that the side access panels, the front access panel, and the hand ports lock securely, and repair if necessary.

Instructions for use Babyleo TN500 SW 1.0n

17

Safety-related information

2.13

Thermal radiation and fire prevention

2.13.1

Radiant warmer Thermal radiation from the radiant warmer may cause increased water loss, skin burns, and eye damage in the patient. ► Do not leave the patient unattended during radiant warmer operation.

2.13.2

Fire prevention Objects placed on the housing of the radiant warmer or on the protective grid may melt or fall off, injuring the patient. There is a risk of fire. ► Do not place objects (e.g., towels) or combustible materials over the housing of the radiant warmer or hang them in front of the protective grid. ► Do not obstruct the ventilation slots on the radiant warmer and do not cover them with combustible materials.

30230

► In radiant warmer operation remove the hood cover and ensure a safety clearance of 20 cm (8 in) between the top edge of the radiant warmer and the ceiling.

Fig. 2

Radiant warmer protective grid

The radiant warmer may heat up objects in the beam path close to the radiant warmer to such an extent that touching the objects causes burns. In addition, the objects may ignite and cause a fire. ► Do not permanently locate objects (e.g., examination lights) in the beam path of the radiant warmer. ► Allow the objects to cool down before touching, to avoid burns. ► Before pivoting accessories (e.g., examination lights) out of the beam path of the radiant warmer, take precautions to prevent burns.

2.13.3

Additional heat sources The temperature in the patient compartment may rise to dangerous levels due to direct sunlight or other external heat sources (e.g., phototherapy devices). The patient may become overheated. ► When additional heat sources (e.g., solar radiation, examination lights, or phototherapy lights) are active, make sure that the temperature in the patient compartment remains non-critical. ► Check the patient's body core temperature at regular intervals.

18

Instructions for use Babyleo TN500 SW 1.0n

Safety-related information

2.13.4

Air flow in the warm air duct If the warm air duct in the device becomes blocked or covered, thermoregulation is disrupted. The hot air flow may reach the patient directly, causing burns. ► Do not block or cover the warm air duct (1) and do not deflect the hot air flow to the patient using objects (e.g., blankets).

30231

The warm air duct passes through the air ducts of the X-ray flap. The convective heater directs the warm air through the air ducts of the X-ray flap into the patient compartment.

1

Fig. 3

Air ducts of the X-ray flap

2.14

Therapy and applications

2.14.1

Ambient conditions If the permissible ambient conditions are not complied with, the values set for humidity and temperature in the patient compartment may not be achieved. The patient may be put at risk. ► Be aware of and comply with the permissible ambient conditions. For further information, see the following chapter: ''Technical data'' (page 188)

2.14.2

Therapy settings If the therapy settings are unsuitable for the patient, the patient may be put at risk. ► Before starting therapy, check the therapy settings carefully. Adjust the therapy settings to the needs of the patient, e.g., after transferring patient data to a new device, after transferring data via a USB port, after changing the operating mode, when using the default settings. ► Measure the body core temperature at regular intervals using a separate thermometer.

Instructions for use Babyleo TN500 SW 1.0n

19

Safety-related information

2.14.3

Increased CO2 concentration in the patient compartment If the device does not have the "Tolerate cooling" option, it must be switched off to cool down. When the device is switched off, an inadequate supply of fresh air may result in an increase in CO2 in the patient compartment. This may put the patient at risk. ► Ensure that the patient has an adequate supply of fresh air when the device is switched off (e.g., by opening a hand port or a side panel).

2.14.4

Skin temperature sensors Incorrect use of the skin temperature sensors may result in hypothermia or hyperthermia. Reused skin temperature sensors may transmit pathogens or may be defective and result in incorrect measurements. The patient is put at risk. ► Only use skin temperature sensors approved for the device. ► The skin temperature sensors are disposable products: Do not reuse, reprocess, or sterilize. ► Incorrect interpretation of the values may result in hypothermia or hyperthermia. ► Do not use the skin temperature sensor as a clinical thermometer and do not use it to measure rectal temperature. ► Use dry skin temperature sensors only. ► Use covers recommended by Dräger only, e.g., ThermoPad sensor covers or similar covers with aluminum film. ► Check the position of the skin temperature sensors at regular intervals. ► Place the yellow skin temperature sensor in the liver or kidney region only. ► Place the white skin temperature sensor on the foot or hand only. ► Do not place the skin temperature sensors under the patient. ► The device cannot distinguish between an increase in body core temperature when the skin is cold (e.g., with a fever) and a low body core temperature (e.g., with hypothermia). Do not use skin temperature mode in cases of fever or shock. ► If skin temperature sensors are connected, do not use radio-frequency surgical equipment, endocardial catheters, or defibrillators.

2.14.5

Air temperature in the device The following situations may lead to hypothermia or hyperthermia in the patient: – The hand ports or access panels are left open. – The mattress tray or x-ray tray is left pulled out. ► Only open the hand ports or access panels temporarily and only for as long as is necessary. ► Only pull out the mattress tray or x-ray tray temporarily and only for as long as is necessary.

20

Instructions for use Babyleo TN500 SW 1.0n