Babyroo TN300 Radiant Warmer Instructions for Use Edition 1

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2

Instructions for use

| Babyroo TN300 SW 1.0n

Contents

Contents Babyroowarmer Radiant TN300

1

2

3

4

Information about this document ...

6

1.1 1.2 1.3 1.4 1.5

Typographical conventions ... Use of terms ... Illustrations... Trademarks... Further information on Masimo pulse oximetry products (option)...

6 6 6 6 7

Safety-related information ...

8

2.1 2.2 2.3 2.4 2.5 2.6 2.7

Intended use ... Indications... Contraindications ... Environments of use ... Essential performance characteristics ... User group requirements ... Operation of the device by persons outside the defined user groups

8 8 8 8 8 9

2.8 2.9 2.10

Information on safety instructions and precautionary statements... Further information ... Safety instructions ...

10 10 10 11

Product description ...

21

3.1 3.2 3.3 3.4 3.5 3.6 3.7

21 26 29 34 35 37 39

Operating concept...

42

Display unit ... Locking and unlocking the screen ... Using the quick setup dialog window... Using the timers... Adjusting the device height (option)... Operating the castor brakes ... Operating the bed-tilt ... Operating the side walls and front end wall ... Resuscitation module (option) ...

42 44 45 45 46 47 48 49 50

Assembly and preparation ...

54

5.1 5.2 5.3 5.4 5.5 5.6 5.7

54 54 54 55 55 56 57

4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 5

Structure and function... Range of functions... Screen views ... Abbreviations ... Symbols ... Symbols in the software... Product labels ...

Maximum load ... Unpacking the device ... Preparing the radiant warmer ... Preparing the scale (if installed) ... Installing the mattress... Installing the disposable 800 mL suction bottle (option) ... Connecting the gas supply (option) ...

Instructions for use | Babyroo TN300 SW 1.0n

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Contents

5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16

Nurse call... Establishing potential equalization... MEDIBUS connection for data transfer... Holding systems ... Fitting the BiliLux phototherapy light (MU20100)... Mounting the VarioLux examination light... Installing the suction bottle holder for GCX (3702751) ... Mounting the suction unit VarioVac P rail (MP00660) ... Mounting the humidifier (F&P MR850) ...

59 60 60 61 65 66 67 68 69

Getting started...

71

6.1 6.2 6.3 6.4

Checking for operational readiness ... Switching on the device ... Checking supply pressure (if installed) ... Checking the resuscitation module (if installed) ...

71 72 76 76

Operation ...

79

7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13

Radiant warmer operation ... Skin temperature mode ... Manual mode ... Heated gel mattress (option) ... SpO2 monitoring (option) ... Kangaroo mode ... Tolerate cooling (option) ... Warm-up (option)... Scale (option)... Taking X-rays... Intrahospital patient transfer ... Operating the resuscitation module (if installed)... Switching off the device ...

79 81 87 90 92 99 103 106 108 113 115 119 125

Alarms ...

127

8.1 8.2 8.3 8.4

Alarm priorities and alarm signals... Silencing and delaying the alarm signal ... Viewing current alarms ... Viewing the alarm history...

127 128 131 131

Trends ...

132

9.1

Displaying trends and data ...

132

10 Configuration...

137

6

7

8

9

10.1 10.2 10.3 10.4 10.5

Safety instructions ... Password ... Entering patient data... Transferring data to another device... Specifying the device settings ...

137 137 138 140 144

11 Troubleshooting ...

150

11.1 11.2

4

Alarm – Cause – Remedy... Power failure alarm...

150 157

Instructions for use | Babyroo TN300 SW 1.0n

Contents

11.3 11.4 11.5 11.6

Adjustment of device height not possible ... Fault during weighing... Resuscitation module ... SpO2 messages...

157 158 159 160

12 Reprocessing...

161

12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8

Safety instructions ... Information on reprocessing ... Classifications for reprocessing ... Before reprocessing... Validated reprocessing procedures ... Other agents and reprocessing procedures ... Reprocessing of patient-specific accessories... After reprocessing...

161 161 161 162 166 169 171 174

13 Service ...

176

13.1 13.2 13.3 13.4 13.5 13.6

Safety instructions ... Definition of service terminology... Inspection ... Maintenance ... Repair ... Activating applications ...

176 176 176 178 179 179

14 Disposal ...

181

14.1 14.2

Safety instructions ... Disposing of the device...

181 181

15 Technical data ...

182

15.7 15.8 15.9

Device combinations... IT networks and cybersecurity ... EMC declaration ...

189 190 194

16 Principles of operation ...

196

16.1 16.2 16.3 16.4

Description of skin temperature regulation ... Further information on heated gel mattress (option)... Automatic self-test ... Schematic representation of alarm and information tones ...

196 196 196 197

Index ...

198

Instructions for use | Babyroo TN300 SW 1.0n

5

Information about this document

1

Information about this document

1.1

Typographical conventions Text

Bold, italicized texts indicate labels on the device and screen texts.

1.

Numbers followed by a period indicate individual action steps in a sequence of actions. Numbering begins with the number 1 for each new sequence of actions.

a.

Lowercase letters followed by a period indicate subordinate action steps. Numbering begins anew with the letter a. for each new subordinate action step.

●

This bullet point indicates individual process steps with no specific sequence.

►

This triangle in safety instructions and precautionary statements indicates ways to avoid danger.

(1)

Numbers in parentheses refer to elements in figures.

1

Numbers in figures indicate elements referred to in the text.

–

Dashes indicate listings.

>

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

1.2



This arrow indicates the result of an action step.

✓

This check mark indicates the result of a sequence of actions.

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

1.3

Illustrations Illustrations of products and screen content in this document may differ from the actual products depending on configuration and design.

1.4

Trademarks

1.4.1

Trademarks owned by Dräger Trademark Babyroo® BiliLux® DrägerService® MEDIBUS.X® SoftBed® VarioLux®

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Instructions for use | Babyroo TN300 SW 1.0n

Information about this document

Trademark VarioVac® The following web page provides a list of the countries in which the trademarks are registered: www.draeger.com/trademarks

1.4.2

Trademarks owned by third-party manufacturers Trademark

Trademark owner

Dismozon

BODE Chemie

acryl-des Mikrozid

Schülke & Mayr

Perform Actichlor Incidin

Ecolab USA

Oxycide Rely+On Virkon

DuPont

Dispatch

Clorox

Klorsept

Medentech

Descogen Oxygenon SteriMax

Antiseptica Aseptix

Masimo SET Apod

Masimo

X-Cal FastSat Cleanisept

Dr. Schumacher

neodisher

Dr. Weigert

1.5

Further information on Masimo pulse oximetry products (option)

1.5.1

Masimo patent information Masimo Patents: www.masimo.com/patents.htm

1.5.2

Masimo no implied license clause Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Instructions for use | Babyroo TN300 SW 1.0n

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Safety-related information

2

Safety-related information

2.1

Intended use The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with patients with a body weight up to 10 kg (22 lb).

2.2

Indications The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.

2.3

Contraindications The device is contraindicated for patients with a body weight above 10 kg (22 lb).The device is not intended for use outside of the specified environments of use.

2.4

Environments of use Babyroo TN300 is intended for use in the following environments of use: – Labor and delivery units – Neonatal intensive care units – Operating rooms Babyroo TN300 is intended for use in the following environments where some of the functions described under intended use are not provided (e.g., no active warming therapy): – During intrahospital transfer

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: – Heat regulation in manual mode Heater power and time limits are monitored and if they are exceeded, an alarm is generated. – Skin temperature regulation The measured skin temperature is compared with the set value and adjusted accordingly, or an alarm is generated. – Optional resuscitation

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Instructions for use | Babyroo TN300 SW 1.0n

Safety-related information

The resuscitation module continuously measures and displays airway pressure during resuscitation. It also continuously measures and displays the subatmospheric pressure during suction operation. If the optional gas mixer is present, an alarm is generated if either the air or the oxygen gas source pressure is low. – Optional mattress temperature regulation The measured mattress temperature is compared with the set value and adjusted accordingly, or an alarm is generated. – Optional pulse oximetry (SpO2) monitoring SpO2 and pulse rate measurements obtained through connected sensors are displayed. The limits of the measured values are monitored and if they are exceeded, an alarm is generated. The product is equipped with basic safety systems to reduce the likelihood of injury to the patient before the circumstance causing the alarm is remedied.

2.6

User group requirements The term "user group" describes the responsible personnel who have been assigned by the operating organization to perform specific tasks on a product.

2.6.1

Duties of the operating organization The operating organization must ensure the following: – Each user group has the required qualification (e.g., has undergone specialist training or acquired specialist knowledge through experience). – Each user group has been trained to perform the task. – Each user group has read and understood the relevant chapters in this document.

2.6.2

User groups Clinical users This user group operates the product in accordance with the intended use. Users have medical specialist knowledge in the field of neonatology. Users have knowledge of device monitoring and neonatal care. Reprocessing personnel This user group carries out the necessary activities to reprocess the product. Reprocessing personnel has specialist knowledge in the reprocessing of medical devices. Service personnel This user group installs the product and performs the service activities. Service personnel has specialist knowledge in electrical and mechanical engineering and experience in the servicing of medical devices. Where product specific knowledge or tools are required, the service activities must be performed by specialized service personnel. The specialized service personnel was trained by Dräger for these service activities on this product.

Instructions for use | Babyroo TN300 SW 1.0n

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Safety-related information

2.7

Operation of the device by persons outside the defined user groups The device is not intended for use by non-specialists (persons not defined as user 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.

2.8

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.

2.8.1

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.

2.8.2

Precautionary statements Precautionary statements relate to action steps and warn of risks that may arise when performing 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

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.

2.9

Further information

2.9.1

Mandatory reporting of incidents Serious incidents with this product must be reported to Dräger and the responsible authorities.

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Instructions for use | Babyroo TN300 SW 1.0n

Safety-related information

2.9.2

Training Training for users is available via the Dräger organization responsible (see www.draeger.com).

2.10

Safety instructions

2.10.1

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. ► Use this product only according to its intended use. ► Keep these instructions for use close to hand. ► Follow these instructions for use and those for any products used in conjunction with this product. 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 one or more illnesses

2.10.2

Use of device Failure to observe proper use of the device may result in personal injury and property damage. ► The device is intended for use in healthcare facilities only, and only trained personnel under the direction of qualified medical staff may operate the device. ► The device can be used in any department of the hospital that provides neonatal and infant care, including all levels of the Neonatal Intensive Care Unit (NICU), Special Baby Care Unit, Step Down Nursery, Newborn Nursery, and Pediatrics. ► Comply with the conditions for operation and storage of the device.

2.10.3

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.

2.10.4

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.

Instructions for use | Babyroo TN300 SW 1.0n

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Safety-related information

2.10.5

Alarm volume If the alarm volume is too low, or if the user is too far away from the device, alarm signals may not be heard. The patient may be put at risk. ► Set the alarm volume loud enough so that the alarm signals can be heard in the environment where the device is located. ► The user must remain within hearing range of the acoustic alarm signals (user position). ► The user’s distance from the device must be limited according to the volume of the acoustic alarm signal.

2.10.6

Service port Use the service port on the device only 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.

2.10.7

Modifications to the product Modifications to the product may lead to malfunctions and unforeseen risks. This may result in injury to the patient or the user or in property damage. ► Do not modify this product.

2.10.8

Safety instructions for accessories

2.10.8.1

Accessories The approved accessories for this product are included in the list of accessories (9511204). The use of other accessories may adversely affect the functional integrity of the product and lead to personal injury and property damage. ► Only use approved accessories. ► Only service personnel are authorized to mount accessories. ► Observe the current list of accessories and the assembly instructions of the device. ► Observe the instructions for use and assembly instructions for the accessories. ► Observe the weight limit for attached accessories. ► When attaching accessories, make sure that the device does not tip over. ► When attaching accessories, do not place any part or accessory in a position that may cause it to fall on the patient.

2.10.8.2

Disposable products Improper use of disposable components or accessories may adversely affect the patient or the function of the device. Personal injury and property damage may occur as a consequence. ► Do not reuse, reprocess, or sterilize disposable products. ► Do not use disposable products if the package has been compromised.

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Instructions for use | Babyroo TN300 SW 1.0n

Safety-related information

2.10.8.3

Hoses and cables Improper routing of hoses and cables and uncontrolled movement of the device or the trolley may result in patient injury or interruption of treatment. The patient is put at risk. ► When using the height adjustment mechanism and the trolley, always make sure that connected hoses and cables are not accidentally disconnected. ► Lock the double castors on the trolley with the locking brakes. ► Only use hoses and cables of sufficient length for height adjustment. ► Securely fasten all hoses and hand-tighten them to fittings to avoid damage to the fittings. ► Use hose and cable management to avoid patient entanglement. ► Route hoses and cables into the bassinet through the hose grommets. ► Do not run hoses and cables over the bassinet.

2.10.8.4

Objects in the bassinet If objects are placed in the bassinet, the patient may be infected by pathogens. The patient may swallow parts and choke. ► Do not place any objects in the bassinet.

2.10.9

Electrical safety

2.10.9.1

Electric shock Under the housing, there are conducting components that 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 user groups authorized to perform the respective service measure. ► Disconnect the power plug before opening the housing. ► Do not simultaneously touch the connectors of the interfaces and the patient. ► Do not operate the device directly after storage in a cold environment. Allow the device to acclimate before connection to power supply. ► Only connect the device to power sockets with protective earth. ► Do not connect the device by means of a power socket strip. ► Do not connect any accessory operating on mains voltage to the USB port. ► Only connect devices to the serial (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 182. ► Do not use a defibrillator if a skin temperature sensor or a heated gel mattress is connected. It could result in electric shock, device malfunction, and ineffective defibrillation. ► Do not allow the trolley castors to roll over the power cable. ► Do not allow any liquids to penetrate into the device.

Instructions for use | Babyroo TN300 SW 1.0n

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Safety-related information

2.10.9.2

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 194). Electrostatic discharge When components that bear the ESD warning symbol are handled, protective measures against electrostatic discharge must be complied with. Otherwise, malfunctions may occur that put the patient at risk. To prevent malfunctions, observe the following measures and train the relevant personnel: ► Follow the ESD protective measures, such as: – Wear antistatic clothing and shoes. – Use electrically insulating and antistatic gloves. – When establishing connections, touch a potential equalization pin. ► Observe the requirements for the electromagnetic environment. Observe the following section: "Electromagnetic environment" (page 194). Electromagnetic disturbances Wireless communication devices (e.g., cellular phones) and medical electrical equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic radiation. When such devices are operated too close to this device or its cables, the functional integrity of this device may be compromised by electromagnetic disturbances. As a result, the patient could be put at risk. ► Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless communication devices, to ensure that the essential performance of this device is fulfilled. ► Maintain an adequate distance between this device and other medical electrical equipment. ► Do not use the device in an MRI environment.

2.10.10

Therapy and applications

2.10.10.1

Ambient conditions If the permissible ambient conditions are not complied with, the values set for temperature in the bassinet 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: "Technical data", page 182.

2.10.10.2

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.

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Instructions for use | Babyroo TN300 SW 1.0n

Safety-related information

2.10.10.3

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 faulty and result in incorrect measurements. The patient is put at risk. ► Only use skin temperature sensors approved for the device. ► Do not reuse, reprocess, or sterilize disposable skin temperature sensors. ► Do not use the skin temperature sensor as a clinical thermometer and do not use it to measure rectal temperature. ► Check the patient’s core temperature regularly with an independent thermometer. ► Use dry skin temperature sensors only. ► Only use sensor covers recommended by Dräger. ► Check the position of the skin temperature sensors at regular intervals to make sure they are attached correctly. ► 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. ► Do not use a defibrillator if skin temperature sensors are connected.

2.10.10.4

Transdermal patches If a patch treated with an active agent (transdermal patch) is applied to the patient's skin during warming therapy, too much of the active agent may be released. This may put the patient at risk. ► Do not apply transdermal patches to the patient's skin during and prior to warming therapy, or be aware of the possibility that the active agent may be absorbed too rapidly.

Instructions for use | Babyroo TN300 SW 1.0n

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Safety-related information

2.10.11

SpO2 monitoring Patient condition should be monitored during SpO2 monitoring to assess if adjustment to treatment is needed. The patient may be put at risk if his or her condition is not adequately monitored. ► The pulse oximeter should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. ► If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. ► If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check the pulse oximeter for proper functioning. ► If the Low perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. ► Variation in measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition. The use of other therapies or equipment during SpO2 monitoring may affect the accuracy of SpO2 measurements. The patient may be put at risk. ► Pulsations from an intra-aortic balloon may affect the accuracy of the pulse rate. The pulse rate should be verified against ECG heart rate. ► When using the pulse oximeter during defibrillation, be aware that this may affect the accuracy or availability of parameters and measurements. ► Ensure that any equipment that emits radio frequency transmissions is not in close proximity to the pulse oximeter. ► If using the pulse oximeter during full body radiation, keep the sensor out of the radiation field. The measurement may be inaccurate or may show zero for the duration of the radiation. The use of the pulse oximeter for purposes outside its intended use may put the patient at risk. ► Do not use the pulse oximeter as an apnea monitor. ► Do not use the pulse oximeter for arrhythmia analysis. Improper use or handling of the pulse oximeter can lead to equipment damage or patient injury. ► Do not place the device on surfaces with visible liquid spills. ► Do not soak or immerse the device in liquids. ► Do not attempt to sterilize the device. ► Use cleaning solutions only as instructed in the manufacturer’s instructions for use. ► Do not attempt to clean the device while in use with a patient. ► Always remove the sensor and completely disconnect the device before bathing the patient. ► Do not adjust, repair, disassemble, or modify the device or accessories. Return to manufacturer for servicing if necessary.

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Instructions for use | Babyroo TN300 SW 1.0n

Safety-related information

2.10.12

Oxygen supply Improper use of supplemental oxygen may be associated with serious side effects including blindness, brain damage, and death. The risks vary with each infant. ► The qualified attending physician should prescribe the method, the concentration, and the duration of oxygen administration. ► Make sure that the O2 settings are correct. ► Use an external oxygen analyzer when oxygen is being delivered. ► Make sure that the oxygen concentration in the bassinet does not exceed 65 %. ► Use continuous pulse oximetry for measuring the oxygen concentration when oxygen is being delivered. ► Always monitor the additional O2 supply from the central gas supply system or an oxygen cylinder. ► In the bassinet use only electrical devices that are approved for use in an oxygen-enriched atmosphere.

2.10.13

Explosion protection In the presence of combustible or explosive mixtures, there is an increased risk of explosion and fire, which may lead to personal injury and property damage. ► Do not use the device in the presence of flammable anesthetic gases or other flammable materials, such as some types of cleaning agents. ► Do not use the device in an oxygen-enriched environment. ► On devices equipped with the resuscitation module, do not perform cauterization procedures near an open patient outlet.

2.10.14

Mechanical safety

2.10.14.1

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 total load of the device together with accessories. ► 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 GCX rail.

2.10.14.2

Trapping of body parts 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. For special hazard areas, see Fig. 1.

Instructions for use | Babyroo TN300 SW 1.0n

17

50641

Safety-related information

1 7 2 6 5 4

Fig. 1 No. 1 2

3 4 5 6 7

3

Special hazard areas during operation Location where there is a risk of injury Between the main column and head end wall (for example, when tilting the bassinet) Between the compressed gas cylinder and the bassinet, or between the compressed gas cylinder and accessories fixed to the GCX rail (for example, when lowering the device) When opening and closing the X-ray tray Between the trolley and the drawer (for example, when lowering the device) When opening and closing the instrument tray On the front between the bassinet and the support frame (for example, when tilting the bassinet) When closing one of the two side walls or the front end wall

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. 2.10.14.3

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.

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Instructions for use | Babyroo TN300 SW 1.0n

Safety-related information

2.10.15

Thermal radiation and fire prevention

2.10.15.1

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.

2.10.15.2

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. ► Do not obstruct the ventilation slots of the power chassis or rear cover.

30230

► During radiant warmer operation, remove the bed canopy 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. 2.10.15.3

Additional heat sources The temperature in the bassinet 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 bassinet remains non-critical. ► Check the patient's body core temperature at regular intervals.

Instructions for use | Babyroo TN300 SW 1.0n

19

Safety-related information

2.10.16

Working light Conducting a medical examination of the patient without the use of lighting with neutral colors may cause inaccurate judgment of patient condition, for example, misinterpretation of the skin color. ► Do not use the working light on the device when examining the patient. ► Always use an examination light in accordance with the standard IEC 60601-241 when examining a patient.

2.10.17

Mains power supply If the device is connected to a power socket with incorrect mains voltage or a power socket without protective earth, an electric shock may occur. Personal injury and property damage may occur as a consequence. ► Connect the device only to power sockets with correct mains voltage and protective earth.

2.10.18

Reprocessing If reprocessing is not performed properly, there is an increased risk of infection and damage to products. This can result in personal injury and property damage. ► Perform reprocessing in accordance with chapter "Reprocessing".

2.10.19

Service If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage. ► Perform the service in accordance with chapter "Service".

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Instructions for use | Babyroo TN300 SW 1.0n