Dräger Babylog VN500 Instructions For Use Manual

Page 1

Instructions for Use

Infinity Acute Care System

WARNING

For a full understanding of the performance characteristics of this medical device, the user should carefully read these Instructions for Use before use of the medical device.

Babylog VN500 Ventilation Unit SW 2.n

Page 2

Working with these Instructions for Use

The title of the main chapter in the header line helps with orientation and navigation.

The instructions for the user combine text and illustrations, providing a comprehensive overview of the device. The information is presented as sequential steps of action, allowing the user to learn directly how to use the device.

The text provides explanations and instructs the user step-by-step in the practical use of the product, with short, clear instructions in easy-to-follow sequence.

1 Consecutive numbers indicate steps of action,

with the numbering restarting with "1" for each new sequence of actions.

Bullet points indicate individual actions or different options for action.

– Dashes indicate the listing of data, options or

objects.

(A) Letters in parentheses refer to elements in the

relevant illustration.

The illustrations show the relationship between the text and the device. Elements mentioned in the text are highlighted. Unnecessary details are omitted.

Schematic renderings of screen images guide the user and allow to reconfirm actions performed. The actual screen images differ in look or in configuation.

A Letters denote elements referred to in the text.

Typing conventions

Any text shown on the screen and any labeling on the device are printed in bold and italics, for example, PEEP, Air or Alarm Settings.

The "greater than" symbol > indicates the navigation path in a dialog window, for example, System setup > Ventilation > Basic settings. In this example, System setup represents the dialog window title, Ventilation represents a horizontal tab and Basic settings a vertical tab.

Trademarks

– Infinity

– Babylog

– QuickSet

–ATC

– Acute Care System

– Medical Cockpit

are trademarks owned by Dräger.

2 Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 3

Definitions

WARNING A WARNING statement provides important in-

formation about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Abbreviations and Symbols

Please refer to "Abbreviations" on page 25 and "Symbols" on page 29 for explanations.

CAUTION

A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property.

NOTE

A NOTE provides additional information intended to avoid inconvenience during operation.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 3

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4 Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

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Content

Working with these Instructions for Use . . . . . . 2

Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Abbreviations and Symbols . . . . . . . . . . . . . . . 3

For Your Safety and that of Your Patients . . 7

General WARNINGS and CAUTIONS . . . . . . 10

Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Indications for use and contraindications . . . . . 16

Environment of use. . . . . . . . . . . . . . . . . . . . . . 16

System Overview . . . . . . . . . . . . . . . . . . . . . . 17

Infinity Acute Care System – Workstation

Neonatal Care . . . . . . . . . . . . . . . . . . . . . . . . . 18

Babylog VN500. . . . . . . . . . . . . . . . . . . . . . . . . 19

Trolley 2 - 90 cm . . . . . . . . . . . . . . . . . . . . . . . 21

Gas supply unit GS500. . . . . . . . . . . . . . . . . . . 22

Power supply unit PS500 . . . . . . . . . . . . . . . . . 22

Range of functions . . . . . . . . . . . . . . . . . . . . . . 23

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Operating Concept . . . . . . . . . . . . . . . . . . . . . 31

Operating concept for Infinity C500 . . . . . . . . . 32

Operating concept for Babylog VN500 . . . . . . 32

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Safety information on preparation . . . . . . . . . . 38

Preparing Trolley 2 - 90 cm . . . . . . . . . . . . . . . 38

Preparing Infinity C500. . . . . . . . . . . . . . . . . . . 41

Preparing Babylog VN500 . . . . . . . . . . . . . . . . 44

Transportation of patients within the

hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Getting Started . . . . . . . . . . . . . . . . . . . . . . . . 57

Safety information on getting started . . . . . . . . 58

Switching on Babylog VN500 and Infinity C500 58

Select patient . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Selecting the breathing circuit and the

breathing gas humidifier. . . . . . . . . . . . . . . . . . 62

Check readiness for operation . . . . . . . . . . . . . 63

Selecting Tube or NIV application mode . . . . 68

Select therapy type . . . . . . . . . . . . . . . . . . . . . 69

Start therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Displaying the status of accessories . . . . . . . . 71

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Setting ventilation . . . . . . . . . . . . . . . . . . . . . . 74

NIV – Non-invasive ventilation . . . . . . . . . . . . 82

Display curves and measured values . . . . . . . 85

Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Oxygen enrichment for suction maneuver. . . . 90

Manual inspiration – Manual inspiration/hold . 92

Medication nebulization . . . . . . . . . . . . . . . . . 93

Gas supply unit GS500 . . . . . . . . . . . . . . . . . . 99

2 Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Standby mode . . . . . . . . . . . . . . . . . . . . . . . . 102

Ending operation . . . . . . . . . . . . . . . . . . . . . . . 103

Storing Babylog VN500 . . . . . . . . . . . . . . . . . . 104

Mains power supply / DC power supply . . . . . 105

Power supply unit PS500 . . . . . . . . . . . . . . . . 107

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Display of alarms. . . . . . . . . . . . . . . . . . . . . . . 112

Displaying information on alarms . . . . . . . . . . 113

Alarm history . . . . . . . . . . . . . . . . . . . . . . . . . 114

Setting the alarm limits . . . . . . . . . . . . . . . . . . 114

Setting the volume of the alarm tone . . . . . . . 116

Suppressing the alarm tone . . . . . . . . . . . . . . 116

Position of the user to the alarm system . . . . . 117

Failure of the acoustic alarm . . . . . . . . . . . . . 117

Trends and Data. . . . . . . . . . . . . . . . . . . . . . . 119

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Displaying trends . . . . . . . . . . . . . . . . . . . . . . 120

Display data . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Display logbook . . . . . . . . . . . . . . . . . . . . . . . . 125

Data export . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

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Content

Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . .127

Information on calibrating the sensors . . . . . . . 128

Neonatal flow sensor calibration . . . . . . . . . . . 129

Calibrating the O

2 sensor . . . . . . . . . . . . . . . . 130

Calibrating the CO2 sensor . . . . . . . . . . . . . . .131

Deactivating or activating monitoring . . . . . . . .137

Neonatal flow monitoring . . . . . . . . . . . . . . . . . 139

Possible displays for measured values . . . . . . 140

Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 141

Information on configuration. . . . . . . . . . . . . . .142

Configuring the screen display . . . . . . . . . . . . 142

Configuring alarm settings . . . . . . . . . . . . . . . . 149

Configuring ventilation settings . . . . . . . . . . . . 151

Importing and exporting configurations . . . . . .159

Installing applications . . . . . . . . . . . . . . . . . . . . 160

Exchange intervals . . . . . . . . . . . . . . . . . . . . . . 161

System settings . . . . . . . . . . . . . . . . . . . . . . . .162

Service dialog. . . . . . . . . . . . . . . . . . . . . . . . . . 164

Alarm – Cause – Remedy . . . . . . . . . . . . . . .165

Cleaning, Disinfection and Sterilization . . . 193

Safety information on reprocessing . . . . . . . . . 194

Dismantling. . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

Reprocessing methods . . . . . . . . . . . . . . . . . . 199

Reprocessing list . . . . . . . . . . . . . . . . . . . . . . .202

Assembling parts . . . . . . . . . . . . . . . . . . . . . . . 204

Before reusing on patient . . . . . . . . . . . . . . . . . 206

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 215

Ambient conditions . . . . . . . . . . . . . . . . . . . . . 216

Set values . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Performance characteristics . . . . . . . . . . . . . . 219

Displayed measured values . . . . . . . . . . . . . . 221

Displayed calculated values . . . . . . . . . . . . . . 223

Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224

Operating data. . . . . . . . . . . . . . . . . . . . . . . . . 226

Device ports . . . . . . . . . . . . . . . . . . . . . . . . . . 229

Automatic alarm limits . . . . . . . . . . . . . . . . . . . 231

Description. . . . . . . . . . . . . . . . . . . . . . . . . . . 235

Description of the ventilation modes . . . . . . . . 236

Additional settings for ventilation. . . . . . . . . . . 249

Special procedures . . . . . . . . . . . . . . . . . . . . . 261

Description of the therapy types . . . . . . . . . . . 264

Automatic leakage compensation . . . . . . . . . 265

Measurements. . . . . . . . . . . . . . . . . . . . . . . . . 266

Pneumatic functional description . . . . . . . . . . 268

Main menu bar structure . . . . . . . . . . . . . . . . 271

Factory-set screen views. . . . . . . . . . . . . . . . . 275

Literature references . . . . . . . . . . . . . . . . . . . 276

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .207

Maintenance intervals for Babylog VN500 . . . .208

Safety inspections . . . . . . . . . . . . . . . . . . . . . . 209

Exchanging the ambient air filter . . . . . . . . . . . 210

Exchanging the diaphragm of the expiratory

valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211

Safety information on disposal . . . . . . . . . . . . .212

Disposing of packaging material . . . . . . . . . . . 212

Disposal of batteries . . . . . . . . . . . . . . . . . . . . 212

Disposal of a neonatal flow sensor . . . . . . . . . 213

Disposal of the medical device . . . . . . . . . . . .213

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 7

For Your Safety and that of Your Patients

Strictly follow these Instructions for Use. . . . . . 8

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Safety inspections . . . . . . . . . . . . . . . . . . . . . . 8

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Not for use in areas of explosion hazard . . . . . 8

Safe connection with other electrical

equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 9

Functional safety . . . . . . . . . . . . . . . . . . . . . . . 10

General WARNINGS and CAUTIONS . . . . . . 10

Note on EMC/ESD risk for the device

function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 12

Installing accessories . . . . . . . . . . . . . . . . . . . . 12

Keep the Instructions for Use . . . . . . . . . . . . . . 12

Monitoring ventilation . . . . . . . . . . . . . . . . . . . . 13

Back-up ventilation with an independent

Manual ventilation device . . . . . . . . . . . . . . . . . 13

Handling Infinity ID components. . . . . . . . . . . . 13

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 7

Page 8

For Your Safety and that of Your Patients

Strictly follow these Instructions for Use

WARNING Any use of the medical device requires full un-

derstanding and strict observation of all portions of these Instructions for Use. The medical device is only to be used for the purpose specified under "Intended use" on page 16 and in conjunction with an appropriate patient monitoring system (see page 9). Observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels. Failure to observe these statements means that the medical device is used outside of its intended use.

Maintenance

WARNING The medical device must be inspected and

serviced regularly by properly trained service personnel. Repair of the medical device may also only be carried out by properly trained service personnel. Dräger recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger recommends that only authentic Dräger Medical repair parts be used for maintenance. Otherwise the correct functioning of the medical device may be compromised. See chapter "Maintenance".

Accessories

WARNI NG Only the accessories indicated on the list of

accessories 9039002 (1st edition or higher) have been tested and approved to be used with the medical device. Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific medical device. Otherwise the correct functioning of the medical device may be compromised.

Not for use in areas of explosion hazard

WARNI NG This medical device is neither approved nor

certified for use in areas where combustible or explosive gas mixtures are likely to occur.

Safe connection with other electrical equipment

WARNI NG Patient hazard

Electrical connections to equipment which is not listed in these Instructions for Use should only be made following consultation with the respective manufacturers.

Safety inspections

The medical device must be subject to regular safety inspections. See chapter "Maintenance".

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 9

For Your Safety and that of Your Patients

Networking

Device combinations approved by Dräger (see Instructions for Use of the individual devices or units) meet the requirements set forth by the following standards:

– IEC 60601-1 (EN 60601-1)

Medical electrical equipment Part 1: General requirements for safety

– IEC 60601-1-1 (EN 60601-1-1)

Medical electrical equipment Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems

– IEC 60601-1-2 (EN 60601-1-2)

Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests

– IEC 60601-1-4 (EN 60601-1-4)

Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems

If Dräger devices or units are connected with other Dräger devices or third-party devices and the resulting combination is not approved by Dräger, the operator is responsible for ensuring that the resulting system meets the requirements set forth by the above standards.

Strictly follow Assembly Instructions and Instructions for Use for each networked device.

This publication excludes references to various hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous.

CAUTION

Patient hazard

Individual measured values und monitoring parameters should not be used as the sole basis for therapeutic decisions.

Patient monitoring

The operators of the medical device are responsible for choosing appropriate safety monitoring that supplies adequate information on medical device performance and patient condition.

Patient safety may be achieved through a wide variety of means ranging from electronic surveillance of medical device performance and patient condition, to simple, direct observation of clinical signs.

The responsibility for the selection of the best level of patient monitoring lies solely with the medical device operator.

Patient safety

The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase and use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained operator. Instructions, WARNING and CAUTION statements are limited, therefore, largely to the specifics of the Dräger medical device.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 9

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For Your Safety and that of Your Patients

Functional safety

The essential performance consists in controlled and monitored patient ventilation with user-defined settings for the monitoring functions – minimum breathing gas flow – maximum airway pressure – minimum and maximum O

breathing gas

or, if a set limit is exceeded, by an appropriate alarm. The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied.

2 concentration in the

General WARNINGS and CAUTIONS

The following WARNINGS and CAUTIONS apply to general operation of the device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of these Instructions for Use or in the Instructions for Use of any product being used with this device.

WARNING This medical device is only intended to be

used by trained medical personnel.

WARNING Medications and other substances based on

inflammable solvents, such as alcohol, must not be used in the patient system. Fire hazard! Adequate ventilation must be ensured if highly inflammable substances are used for disinfection.

WARNI NG Fire hazard!

Do not use the medical device in conjunction with flammable gases or flammable solutions that can mix with air, oxygen or nitrous oxide, or other sources of ignition since the medical device could ignite. Do not allow the medical device to come into contact with sources of ignition.

WARNI NG Do not use the medical device during magnet-

ic resonance (MRI, NMR, NMI)! This may impair correct functioning of the medical device and endanger the patient.

WARNI NG Do not use the medical device in hyperbaric

chambers! This may impair correct functioning of the medical device and endanger the patient.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 11

For Your Safety and that of Your Patients

WARNING Correct functioning of the medical device may

be impaired by operation of high-frequency electrosurgery units, defibrillators or shortwave therapy equipment and endanger the patient.

WARNING Do not open the housing of the medical de-

vice. Danger of electrical shock.

WARNING Fire hazard!

Do not use the medical device in oxygenenriched rooms since the medical device could ignite. Medical device malfunctions can increase the

2 concentration in the ambient air. The med-

O ical device is only suitable for use in rooms with adequate ventilation.

WARNING Do not obstruct the gas inlet for the safety

valve. Otherwise, spontaneous breathing via the emergency breathing valve is not possible in the event of a device failure.

CAUTION

Do not use the medical device outside of the specified ambient conditions. This can disrupt the proper functioning of the medical device.

CAUTION

Keep away from sources of heat such as direct sunlight, heat radiators or spotlights! Otherwise the medical device may become too hot.

CAUTION

Do not obstruct or close off the vents on the medical device. Make sure there is an adequate supply of air. Otherwise the medical device may become too hot. An alarm is triggered if the medical device overheats during operation.

CAUTION

Positive-pressure ventilation can lead to negative effects, such as barotrauma or strain on the circulatory system.

WARNING With neonates, the administration of in-

creased O2 concentrations can lead to retinopathy of prematurity. Use additional monitoring, e.g. external SpO

WARNING During HFO, the disconnection detection and

MV monitoring are only possible to a limited extent. For this reason, use external monitoring for MV and disconnection during HFO.

CAUTION

Do not expose the medical device to strong infrared radiation. This can disrupt the proper functioning of the medical device.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 11

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For Your Safety and that of Your Patients

Note on EMC/ESD risk for the device function

General information on electromagnetic compatibility EMC/ESD pursuant to international EMC standard IEC 60601-1-2:

Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided. Observe the separate Instructions for Use "Workstation Critical Care and Workstation Neonatal Care".

Portable and mobile RF communications equipment can affect medical electrical equipment.

WARNING

Connector pins with an electrostatic discharge (ESD) warning sign should not be touched and no connections should be made be-

tween these connectors without implementing ESD protective measures. Such precautionary procedures may include antistatic clothing and shoes, the touch of a ground stud before and during connecting the pins or the use of electrically isolating and antistatic gloves. All staff involved in the above shall receive instruction in these ESD precautionary procedures.

Sterile accessories

CAUTION

Do not use sterile-packaged accessories if the packaging has been opened, is damaged or there are other signs of non-sterility. Disposable articles may not be reprocessed and resteralized.

Reuse, reprocessing or sterilization of disposable medical products can lead to a failure of the medical devices and cause injuries to the patient.

Installing accessories

CAUTION

Installation to the basic device must be in accordance with the Instructions for Use for the basic device. Check that connection is secure with the basic device system.

Strictly follow Assembly Instructions and Instructions for Use.

Keep the Instructions for Use

CAUTION

The Instructions for Use must be kept in an accessible location for users.

WARNING Do not use portable and mobile HF communi-

cations equipment, e.g., mobile phones, in the vicinity of the medical device.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

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For Your Safety and that of Your Patients

Monitoring ventilation

The following parameters are monitored by the built-in monitoring facilities of Babylog VN500: – Airway pressure – Expiratory minute volume – Respiratory rate – Apnea alarm time – Inspiratory O – End-expiratory CO

2 concentration

Changes in these parameters may be caused by: – Acute changes in the patient's condition – Incorrect settings and faulty handling – Device malfunctions – Failure of power and gas supplies

If a fault occurs in this equipment, separate measuring instruments should be used.

During O

2 therapy, the monitoring functions of the

medical device are restricted. See chapter "O2 Therapy" on page 100.

Back-up ventilation with an independent Manual ventilation device

WARNING If a fault is detected in the medical device, its

life-support functions may no longer be assured. Ventilation of a patient using an independent ventilation device must be started without delay, if necessary with PEEP and/or an increased inspiratory O (e.g., with manual breathing bag MR-100).

2 concentration

Handling Infinity ID components

Through ownership or purchase of this medical device equipped with RFID technology, you have only acquired the right to use the medical device and RFID technology in conjunction with products approved by Dräger and in strict compliance with these Instructions for Use. No intellectual property rights or any rights to the use of the medical device or RFID technology are hereby granted, either explicitly or implicitly, which are contrary to the abovementioned conditions.

WARNING Patient hazard

Although Babylog VN500 does not exceed the valid limit values for electromagnetic fields, radiation can interfere with the functioning of pacemakers. Wearers of pacemakers must keep a distance of at least 25 cm (10 inches) from the medical device.

Emission of high-frequency energy

This medical device is equipped with an RFID (Radio Frequency Identification) system to enable wireless communication with Infinity ID accessories. Any changes or modifications to the RFID system may only be carried out by properly trained service personnel. Otherwise this may compromise patient safety.

This medical device has been designed and manufactured to comply with emission limit values for high-frequency energy. These limit values are incorporated in international safety standards like IEC 60601-1-2 (EN 60601-1-2) which have been defined by regulation authorities, such as the Federal Communications Commission (FCC Rules), Industry Canada (Radio Standards Specifications) and the European Telecommunications Standards Institute (ETSI standards).

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For Your Safety and that of Your Patients

The RFID system of this medical device complies with Part 15 of the FCC regulations, and its operation is subject to the following conditions:

1 This medical device does not cause any dan-

gerous interference.

2 The medical device is not liable to damage

caused by the reception of interference, including interference causing undesired operating conditions.

Dräger hereby declares that the ventilation unit Babylog VN500 is in compliance with the basic requirements and the other pertinent regulations of Directive 1999/5/EC.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 15

Application

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Indications for use and contraindications . . 16

Environment of use . . . . . . . . . . . . . . . . . . . . 16

Application

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Page 16

Application

Intended use

The Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal and pediatric patients. Babylog VN500 offers mandatory ventilation modes and ventilation modes for spontaneous

breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas.

Indications for use and contraindications

Indications

The Babylog VN500 ventilation unit is used in combination with Infinity C Series Dräger Medical Cockpits. Babylog VN500 is intended to be used on patients needing respiratory support for different medical reasons temporarily or for longer time.

Contraindications

There are no additional contraindications apart from the contraindications contained in chapter "For Your Safety and that of Your Patients".

It is up to the medical user to select the appropriate respiratory mode for the underlying disease of the patient. For all ventilator settings, the user needs to consider the respiratory status and the general state of health of the patient in order to optimally adapt the ventilation settings to the patient's condition. Any changes to the patient's state need to be monitored continuously.

Environment of use

Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Babylog VN500 must not be used: – In hyperbaric chambers – For magnetic resonance imaging

(MRT, NMR, NMI)

– In conjunction with flammable gases or flamma-

ble solutions that can mix with air, oxygen or

nitrous oxide – In areas of explosion hazard – In areas with combustible or explosive

substances

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

– In rooms without adequate ventilation

Page 17

System Overview

Infinity Acute Care System –

Workstation Neonatal Care . . . . . . . . . . . . . . 18

How to use the Workstation Neonatal Care . . . 18

Babylog VN500 . . . . . . . . . . . . . . . . . . . . . . . . 19

Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Left side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Right side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Trolley 2 - 90 cm . . . . . . . . . . . . . . . . . . . . . . . 21

Gas supply unit GS500 . . . . . . . . . . . . . . . . . 22

Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Power supply unit PS500. . . . . . . . . . . . . . . . 22

Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

System Overview

Range of functions . . . . . . . . . . . . . . . . . . . . . 23

Ventilation functions of Babylog VN500 . . . . . . 23

Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Connections for the breathing hoses . . . . . . . . 24

Electrical power supply. . . . . . . . . . . . . . . . . . . 24

Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Medication nebulizer. . . . . . . . . . . . . . . . . . . . . 24

Connecting accessories . . . . . . . . . . . . . . . . . . 24

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 25

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 17

Page 18

System Overview

Infinity Acute Care System – Workstation Neonatal Care

How to use the Workstation Neonatal Care

The Workstation Neonatal Care can consist of the following units: – Infinity C500 (Medical Cockpit) – Babylog VN500 (ventilation unit) – Trolley 2 - 90 cm (trolley) – GS500 (gas supply unit) – PS500 (power supply unit) – Transport Supply Unit (transport supply unit)

Before using the Workstation Neonatal Care, carefully read the following Instructions for Use: – Instructions for Use for "Workstation Critical

Care and Workstation Neonatal Care"

– Instructions for Use for "Infinity Medical Cock-

pits" – Instructions for Use for "Babylog VN500" – Instructions for Use for "Transport Supply Unit"

The Workstation Neonatal Care may include additional accessories, see separate list of accessories.

A Infinity C500 – control and display unit (Medical

Cockpit). Strictly follow the Instructions for Use for "Infinity Medical Cockpits".

B Babylog VN500 – ventilation unit

C GS500 – gas supply unit

D PS500 – power supply unit

E Trolley 2 - 90 cm

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

001

Page 19

Babylog VN500

A B

System Overview

Front

Front, flap closed

A Operation display of ventilation

During ventilation, the inspiratory and expiratory phases are indicated by a bar display. The measured values for minute volume MV and the inspiratory O played.

B Infinity ID neonatal expiratory valve with

expiratory port Exp. (GAS RETURN)

C Inspiratory unit (safety valve with inspiratory

port) Insp. (GAS OUTPUT)

D Gas inlet for the safety valve Emergency air

intake, non-tapered connection (EMERGENCY

AIR INTAKE), do not obstruct

E Water trap

F Flap

2 concentration FiO2 are also dis-

Front, flap folded upwards

G Silencer

070

H Gas outlet Exhaust, non-tapered connection

(EXHAUST – NOT FOR SPIROMETER)

I Connections for future extensions

J Nebulizer port (nebulizer gas outlet for pneu-

matic medication nebulizer)

071

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 19

Page 20

System Overview

A B

D E

Rear

A Fuse for the internal battery

B Connection for the neonatal flow sensor V5

C Connections for future extensions V6, V8

D Connection for CO

E Potential equalization pin

F Fuse for mains power supply F1, F2

G Connection for mains power supply

2 sensor V7

Left side

004

005

A Connection for system cable to Infinity C500 V1

B Connections for future extensions V2, V3

C Connection for nurse call V4

D Toggle switch

E Ambient air filter with cover

F Strain relief for cable

G Left device flap

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 21

System Overview

Right side

Trolley 2 - 90 cm

A Connection for data cable to the gas supply unit

GS500 V9

B Connection for gas connection to the gas

supply unit GS500

C Connection for Air compressed gas hose Air

(FRESH GAS)

D Connection for O

(FRESH GAS)

E Right device flap

014

A Holder for Infinity C500

B Handle

C Trolley column

D Hose hooks

E Alignment aid

F Humidifier holder, can be swiveled

G Universal holder with standard rail

H Double castors with locking brake, set of 4

2 compressed gas hose O2

038

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 21

Page 22

System Overview

Gas supply unit GS500

Front

A LED for display of mains power supply

Power supply unit PS500

Front

Rear

333

B Rating plate

C Gas connection

Rear

330

A Fault indicator

B Charge indicator

C Standby key

D LED for display of mains power supply

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

332

E Cable duct

F Toggle switch of the power supply unit

G Rating plate

331

Page 23

Range of functions

System Overview

The functions described correspond to the overall functionality of Babylog VN500. Some functions are only optional and may not be included in the individual device configuration. Optional functions are shown in the separate list of accessories.

Ventilation functions of Babylog VN500

Ventilation modes: – Pressure-controlled ventilation:

– PC-CMV –PC-AC –PC-SIMV –PC-PSV –PC-APRV – PC-HFO –PC-MMV

– Support of spontaneous breathing:

– SPN-CPAP/PS – SPN-CPAP/VS –SPN-PPS

Additional settings for ventilation: – Apnea Ventilation – Flow trigger –Sigh – Volume Guarantee –ATC – AutoRelease –HFO-Sigh – Volume Guarantee (HFO)

Special procedures: – Suction maneuver – Manual inspiration/hold – Medication nebulization

Therapy types: – Invasive ventilation (Tube)

2 Therapy

–O – Non-invasive ventilation (NIV)

Additional information

For a detailed description of the ventilation modes and the additional settings see page 236. Abbreviations see page 25.

Monitoring

Patient monitoring is supported by the following alarm limit settings: – Maximum airway pressure Paw – Expiratory minute volume MV – Apnea alarm time Tapn – Respiratory rate RR – End-expiratory CO

The inspiratory O2 concentration is monitored by automatically set limits.

Babylog VN500 offers the following displays: – Curves – Graphic trends – Numeric trends – Loops – Alarm history – Logbook – Numeric parameters – Preconfigured lists for measured values and set

values

– Customized lists for measured values and set

values

– Smart Pulmonary View

During non-invasive ventilation and O certain monitoring functions are switched off or can be switched off.

2 concentration etCO2

2 therapy,

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 23

Page 24

System Overview

Connections for the breathing hoses

For connection of the breathing hoses, the standard IEC 60601-2-12 stipulates conical inspiratory ports and expiratory ports as per ISO 5356-1 with a diameter of 15 mm (0.59 inches) or 22 mm (0.87 inches). Babylog VN500 has, like Babylog 8000, conical inspiratory ports and expiratory ports with a diameter of 11 mm (0.43 inches).

Electrical power supply

Babylog VN500 is designed for connection to the hospital's mains power supply with 100 to 240 V at 50/60 Hz. If the mains power supply fails, Babylog VN500 switches over (without interruption) to the internal battery in order to ensure that operation can continue for at least 30 minutes (provided that the battery is fully charged and new).

Power supply unit PS500

The Workstation Neonatal Care may also be equipped with the external power supply unit PS500.

PS500 is designed for connection to the hospital's mains power supply (voltage ranges, see page 51). If the mains power supply fails, PS500 switches over (without interruption) to the internal batteries in order to ensure that the operation of the Workstation Neonatal Care can continue for at least 100 minutes (provided that the batteries are new, fully charged and ventilation is typical). Battery operation is possible for longer in the absence of the gas supply unit GS500.

Gas supply

Gas supply unit GS500

The Workstation Neonatal Care may also be equipped with the external gas supply unit GS500. GS500 supplies Babylog VN500 with compressed air.

Data transfer

A variety of interfaces can be used for transferring data: – USB port for data export and configuration ex-

change using a USB storage media – USB port for installation of optional applications

using an SIM card reader with SIM card – RS 232 port on Infinity C500 for data transfer

with the MEDIBUS protocol

Medication nebulizer

For medication nebulization a pneumatic medication nebulizer can be connected.

Connecting accessories

A humidifier and other approved accessories can be connected to the lateral rails of Babylog VN500. In so doing, it must be ensured that the maximum weight of 4 kg (8.8 lbs) does not exceed a maximum distance of 10 cm (3.9 inches).

For hose holders connected to the lateral rails of Babylog VN500, the maximum weight of 1 kg (2.2 lbs) must not exceed a maximum distance of 100 cm (39.4 inches).

The accessories can also be connected to the holders provided on the trolley.

Babylog VN500 features country-specific connections for the gas supply with oxygen and medical air.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 25

Abbreviations

System Overview

Abbreviation Explanation

% leak Leakage in percent

% Tplat Plateau time in % to the inspiratory

time (set value)

%MVspon Spontaneous breathing portion of

minute volume in percent

Air Connection for Air compressed gas

hose (FRESH GAS)

ALARM RESET

Acknowledging an alarm message that is no longer active ("Reset")

Ampl hf Pressure amplitude for HFO

(set value)

Apnea Vent. Apnea ventilation

APRV Airway Pressure Release

Ventilation

ATC Automatic Tube Compensation,

compensation of the tube resistance

BF Insulation class Body Floating

BTPS Body Temperature Pressure

Saturated, measured values based on the condition of the patient’s lungs, body temperature 37 °C (98.6 °F), water vapor-saturated gas, atmospheric pressure

C Compliance

C20/Cdyn Index of the last 20 % of compli-

ance in relation to the dynamic total compliance

Cdyn Dynamic compliance

2O Measuring unit for pressure

cmH

1cmH

2O = approx. 1 mbar

Compens. Degree of tube compensation

COPD Chronic Obstructive Pulmonary

Disease

Cycles sigh Number of cycles during a sigh

phase (set value)

Abbreviation Explanation

2 Dissociation coefficient for CO2

DCO

with HFO

ΔintPEEP Additional intermittent PEEP for

sigh (set value)

ΔPhf Maximum pressure difference of

amplitude with HFO

ΔPsupp Pressure support relative

(above PEEP) (set value)

E Elastance

EIP End Inspiratory Pressure,

end-inspiratory pressure

EMC Electromagnetic compatibility

Emergency air intake

Safety air inlet, inspiratory relief valve (EMERGENCY AIR INTAKE)

ESD Electrostatic Discharge

ET Endotracheal tube

2 End-expiratory CO2 concentration

etCO

ETSI European Telecommunications

Standards Institute, European Telecommunications Standards Institute

Exhaust Gas outlet (EXHAUST – NOT FOR

SPIROMETER)

Exp. Label on the device, Expiratory port

(GAS RETURN)

Exp. Expiration

Exp. term. Termination criterion in % from the

peak expiratory flow

FCC Federal Communications

Commission, approval authority for communications devices in the U.S.

fhf Frequency of oscillation for HFO

(set value)

2 Inspiratory O2 concentration

FiO

(set value)

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 25

Page 26

System Overview

Abbreviation Explanation

Flow Flow (set value)

Flow Assist Flow support in SPN-PPS

(set value)

Flow trigger Trigger threshold, sensitivity

(set value)

Flowsigh Flow of sighs for HFO

FRC Functional Residual Capacity

GS500 Gas supply unit

HF High frequency

HFO High Frequency Oscillation

HME Heat Moisture Exchanger

hPa Hectopascal, measuring unit for

pressure 1hPa = 1mbar = approx. 1cmH

I:E Ratio of inspiratory time to

expiratory time

I:Ehf I:E for HFO (set value)

I:Espon I:E during spontaneous breathing

IEC/CEI Alarm tone as per IEC 60601-1-8

Insp. Label on the device, Inspiratory

port (GAS OUTPUT)

Insp. Inspiration

Insp. flow Inspiratory flow

Interval sigh Time interval between two sigh

phases (set value)

LAN Local Area Network

MAPhf Mean airway pressure for HFO

(set value)

mbar Millibar, measuring unit for

pressure 1 mbar = approx.

1cmH

MEDIBUS Dräger communication protocol for

medical devices

mmHg Measuring unit for end-expiratory

2 concentration

More... Show more alarms

MRI Magnetic resonance imaging

Abbreviation Explanation

MV Overall minute volume

MV high Upper alarm limit for minute volume

MV low Lower alarm limit for minute volume

MVleak Leakage minute volume

MVmand Mandatory portion of minute

volume

MVspon Spontaneous breathing portion of

minute volume

Neo. Neonates patient category

NIV Non-Invasive Ventilation

NMI Nuclear magnetic imaging

NMR Nuclear magnetic resonance

NTPD Normal Temperature Pressure Dry,

20 °C (68 °F), 1013 hPa, dry

2 Connection for O2 compressed gas

hose (FRESH GAS)

2 suction Suction maneuver

Palv Alveolar pressure

Paw Airway pressure

Paw high Upper alarm limit for airway

pressure

PC-AC Pressure Control-Assist Control,

assisted-controlled, pressurecontrolled ventilation with back-up respiratory rate

PC-APRV Pressure Control-Airway Pressure

Release Ventilation, spontaneous breathing under continuous positive airway pressure with brief pressure releases

PC-CMV Pressure Control-Continuous

Mandatory Ventilation, continuous pressure-controlled ventilation

PC-HFO Pressure Control-High Frequency

Oscillation, pressure-controlled ventilation with high-frequency oscillation

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 27

System Overview

Abbreviation Explanation

PC-MMV Pressure Control-Mandatory

Minute Volume Ventilation, pressure-controlled ventilation to ensure a mandatory volume per minute

PC-PSV Pressure Control-Pressure

Support Ventilation, spontaneous breathing at continuous positive pressure level with pressure support and back-up respiratory rate

PC-SIMV Pressure Control-Synchronized

Intermittent Mandatory Ventilation, intermittent, triggered, pressurecontrolled ventilation

Ped. pat. Pediatric patient category

PEEP Positive end-expiratory pressure

Phigh Upper pressure level in APRV

(set value)

Pinsp Inspiratory pressure (set value)

PIP Peak Inspiratory Pressure

Plow Lower pressure level in APRV

(set value)

PmanInsp Pressure of the mandatory breath

for the manual inspiration during NIV (patient category Neo., ventilation mode SPN-CPAP)

Pmax Maximum allowed airway pressure

(set value)

Pmax/Paw high autoset

Linking the maximum airway pressure to the alarm limit Paw high

Pmean Mean airway pressure

Pmin Minimum airway pressure

Pplat Airway pressure on the plateau

PS Pressure Support

PS500 Power supply unit

Psigh Inspiratory pressure of sigh for

HFO (set value)

Psupp Pressure support absolute

Abbreviation Explanation

Ptrach Pressure in the trachea

R Resistance (resistance)

r² Correlation coefficient for the

calculation method "Least Mean Square" for R, C and Τau

REF Material and revision number of the

medical device

RFID Radio Frequency Identification

RR Respiratory rate (set value)

RRapn Respiratory rate of apnea

ventilation (set value)

RRmand Mandatory portion of respiratory

rate

RRsigh Respiratory rate of sighs for HFO

(set value)

RRspon Spontaneous breathing portion of

respiratory rate

RSB Rapid Shallow Breathing, quotient

of spontaneous respiratory rate and tidal volume

SIM Subscriber Identity Module,

participant identification

Slope Pressure rise time (set value)

Slopesigh Pressure rise time of sighs for HFO

Smart Pulmonary

Graphic display of lung characteristics

View

SN Device serial number

SPN-CPAP Spontaneous-Continuous Positive

Airway Pressure, spontaneous breathing with continuous positive pressure level

SPNCPAP/PS

Spontaneous-Continuous Positive Airway Pressure/Pressure Support, spontaneous breathing with continuous positive pressure level with or without pressure support

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 27

Page 28

System Overview

Abbreviation Explanation

SPNCPAP/VS

Spontaneous-Continuous Positive Airway Pressure/Volume Support, spontaneous breathing with continuous positive pressure level with or without volume support

SPN-PPS Spontaneous-Proportional

Pressure Support, spontaneous breathing with flow-proportional and volume-proportional pressure support

2 Partial O2 saturation

SpO

Tapn Apnea alarm time (set value)

Τau Time constant tau

Tdisconnect Time for disconnection alarm

(set value)

Te Expiratory time (set value)

Thigh Time of upper pressure level in

APRV (set value)

Ti Inspiratory time (set value)

Timax Maximum inspiratory time for flow

during pressure or volume support (set value)

Tisigh Inspiratory time of sigh for HFO

(set value)

Tispon Inspiratory time of sigh for

spontaneous breathing

Tisupp Inspiratory time during pressure

support

Tlow Time of lower pressure level in

APRV

Tlow max Maximum expiratory time during

APRV (set value)

TmanInsp Duration of the breath for the

manual inspiration during NIV (Neo. patient category, SPN-CPAP ventilation mode)

Tplat Time of inspiratory plateau

Trach. Tracheostomy tube

Tube Ø Inside diameter of tube (set value)

Abbreviation Explanation

UIP Upper Inflection Point

UMDNS Universal Medical Device

Nomenclature System, nomenclature for medical devices

N Rated voltage

USB Universal Serial Bus, serial bus

system

VG Volume Guarantee

VG (HF) Volume Guarantee for HFO

Vol. Assist Volume support in SPN-PPS

(set value)

VS Volume Support

VT Tidal Volume

VTapn Tidal volume of apnea ventilation

(set value)

VTe Expiratory tidal volume

VTemand Expiratory tidal volume during a

mandatory breath

VTespon Expiratory tidal volume during a

spontaneous breath

VThf Tidal volume for HFO (set value for

VG (HF))

VTi Inspiratory tidal volume

VTimand Inspiratory tidal volume during a

mandatory breath

VTispon Inspiratory tidal volume during a

spontaneous breath

VTmand Tidal volume during a mandatory

breath

VTspon Tidal volume during a spontaneous

breath

WOB Work of Breathing

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 29

Symbols

123

Audio paused

System Overview

Symbol Explanation

Temporarily suppress acoustic alarm

Group Views, screen displays

Group Trends/Data, information on the course of ventilation

Group Special procedures

Group Alarms

Group Therapy, ventilation parameter settings

Group configuration, system settings and settings for sensors

Group Start/Standby

System on or off (at the key on Infinity C500)

Switching the power supply unit on or off (at the key on PS500)

Alarm limit off

Configure trends

Save screen display

Medication nebulizer

Charge state of internal batteries (Babylog VN500, PS500) 90 to 100 %

Charge state of internal batteries (Babylog VN500, PS500) 60 to <90 %

Charge state of internal batteries (Babylog VN500, PS500) 40 to <60 %

Charge state of internal batteries (Babylog VN500, PS500) 20 to <40 %

Symbol Explanation

Charge state of internal batteries (Babylog VN500, PS500) <20 %

Internal batteries (Babylog VN500, PS500) defective or no information available on their charge state

Lower alarm limit

Upper alarm limit

Setting or access locked

Expiratory valve locked

Setting or access unlocked

Expiratory valve unlocked

Exhaust

Gas outlet (EXHAUST – NOT FOR SPIROMETER)

Patient category pediatric patients (Ped. pat.)

Neonates patient category (Neo.)

Display additional information or open Help

Hide additional information or close Help

Scroll in tables or lists

Close dialog window

Active test in the device check

Spontaneous breathing activity by the patient

Suppress acoustic alarm for 2 minutes

Mains power supply (AC voltage)

PS500, GS500: Mains power supply (AC voltage)

Power supply from the internal battery of Babylog VN500

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 29

Page 30

System Overview

Symbol Explanation

Caution: Observe important safety information and precautions in the Instructions for Use.

Observe the Instructions for Use

PS500: Failure, fault

Connection for equipotential bonding

Application part type BF

Nurse call

Marking point on the trolley – do not lean, press, push or pull against the trolley above the marking points

ESD warning symbol

Information on disposal

Manufacturer

2009

Manufacturing date

Connection for the neonatal flow sensor

Device ready to switch on

Device switched off

Labeling for FCC approval

Labeling in accordance with Directive 93/42/EEC concerning medical products

Labeling in accordance with Directive 1999/5/EC on radio equipment and telecommunications terminal equipment

Serial interface (on Infinity C500)

Additional symbols on Infinity C500 (Medical Cockpit) that are not described in these Instructions for Use are described in the Instructions for Use for "Infinity Medical Cockpits".

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 31

Operating Concept

Operating concept for Infinity C500 . . . . . . . 32

Operating concept for Babylog VN500. . . . . 32

Main screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . 33

Dialog windows. . . . . . . . . . . . . . . . . . . . . . . . . 34

Therapy bar . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Therapy controls. . . . . . . . . . . . . . . . . . . . . . . . 34

Setting ventilation parameters . . . . . . . . . . . . . 34

Exceeding the set limit of a ventilation

parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Direct setting of ventilation parameters

(QuickSet). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Linked setting of ventilation parameters . . . . . . 35

Operating Concept

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 31

Page 32

Operating Concept

123

Operating concept for Infinity C500

Infinity C500 is the central operating and display unit. The general operating concept is described in the Instructions for Use for "Infinity Medical Cockpits".

Operating concept for Babylog VN500

The following operating concept only contains the specific information and operating steps for Babylog VN500. This chapter describes: – Main screen – Main menu bar – Dialog windows – Therapy bar – Therapy controls – Setting ventilation parameters – Exceeding the set limit of a ventilation

parameter

– Direct setting of ventilation parameters

(QuickSet)

– Linked setting of ventilation parameters

Main screen

The main screen displays the most important ventilation information at a glance.

A Header bar with the following fields:

– Patient category, see page 60

– System data, e.g., state of charge of the in-

ternal battery, see page 106

– Therapy status: Therapy type (ventilation or

O2 Therapy), ventilation mode and additional settings

– Alarms, messages and instructions for the

user, see page 112

– Alarm status

B Monitoring area with curves, loops, trends and

measured values, see page 85. The display

can be configured, see page 144.

C Main menu bar with buttons for opening dialog

windows and activating functions, see page 33.

D Therapy bar with the therapy controls for the

ventilation parameters of the active ventilation

mode, see page 34.

078

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 33

Operating Concept

Main menu bar

The main menu bar contains fixed assigned and configurable buttons. The buttons are assigned to various groups. Touching a button opens the corresponding dialog window or activates the corresponding function.

Fixed assigned buttons

F Views... for switching to other configured moni-

toring area views, see page 85.

G Trends/Data... for displaying all the measured

and set values, logbook, trends and for exporting data, see page 119.

H Special procedures... for selecting additional

functions, e.g., suction maneuver, see page 90 or medication nebulization, see page 93.

Configurable buttons

Additional buttons for directly accessing functions or dialogs can be configured. These buttons are spatially assigned to the corresponding group. See "Assigning functions to additional buttons" on page 146.

100

A Alarms... for setting the alarm limits and dis-

playing the alarm logbook and listing all active alarms, see page 112.

B Ventilation settings... for setting the ventilation

mode and the ventilation parameters, see page 74.

C Sensors/ Parameters... for calibrating the sen-

sors, see page 128, and for activating or deactivating monitoring, see page 137.

D System setup... for configuring the device

functions, see page 141.

E Start/ Standby... for selecting standby mode or

starting the therapy, see page 102.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 33

Page 34

Operating Concept

Ventilation settings

Dialog windows

Dialog windows consist of one or several pages which are displayed by touching the corresponding horizontal or vertical tab. Dialog windows contain elements for operating the device and inform the user of current settings. Dialog windows can be opened by touching a button in the main menu bar.

A Dialog window title

B Tab to open a page

C Message field for dialog-specific information

and instructions

D Button for accessing additional information and

the Help function (if available)

E Button for closing the dialog window

Therapy bar

The therapy bar on the main screen contains the therapy controls for the active ventilation mode.

Therapy controls

The therapy controls (A) are used to set the ventilation parameters.

Therapy controls are contained in the therapy bar of the active ventilation mode and in the dialog window for the ventilation settings.

171078

Start-up settings

Arrows beside the scales on the screen knobs indicate the start-up values valid when Babylog VN500 is switched on. These start-up values can be adjusted specifically as required by the hospital. See "Configuring start-up settings for the ventilation parameters" on page 153.

Locking mechanism

The therapy controls in the therapy bar can be locked against the ventilation parameters being changed by accident. See "Locking of therapy controls in therapy bar" on page 148.

083128

A Name of active ventilation mode

B Message field for specific messages on the ac-

tive ventilation mode

C Button for opening the dialog window for the

ventilation settings of the active ventilation mode

D Therapy controls

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Setting ventilation parameters

1 Touch the therapy control. The color turns yel-

low. The unit of the parameter to be adjusted is

displayed in parentheses.

2 Turn the rotary knob to set the value.

Page 35

Operating Concept

B A

Ventilation settings

3 Press the rotary knob to confirm the value. The

color of the therapy control turns dark green.

The following chapters of the Instructions for Use provide a simplified explanation of these steps: "Use the rotary knob to set and confirm the value."

Exceeding the set limit of a ventilation parameter

When a set limit of a parameter has been reached, Babylog VN500 displays a message.

z Press the rotary knob to exceed the set limit.

The set limit can be exceeded.

If the maximum set limit for a parameter has been reached, e.g., depending on other parameters, it is not possible to exceed the set limit.

z Press the rotary knob. Babylog VN500 adopts

the maximum possible set value.

Direct setting of ventilation parameters (QuickSet)

The therapy control changes to dark green with a yellow edge. The direct setting function is now active.

087085

3 Press and hold the rotary knob and turn to set

the value.

The set value is immediately effective.

Exceeding the set limit of a parameter with direct setting

When a set limit of a parameter has been reached, Babylog VN500 displays a message.

4 Release rotary knob for a short moment.

5 Press the rotary knob again and turn it.

The set limit can be exceeded.

When a ventilation parameter is set directly, the changes to a setting become immediately effective for the patient. The user can immediately see the effect the changed setting has on the patient. The finally chosen setting does not have to be confirmed again.

Ventilation parameters can be set directly in all ventilation modes and can be carried out in the dialog window for the ventilation settings. Direct settings are only possible in the therapy bar when the therapy controls are not locked.

Setting ventilation parameters directly

1 Touch the corresponding therapy control.

2 Press and hold the rotary knob for approx.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 35

2 and Flow cannot be set directly.

3 seconds.

Linked setting of ventilation parameters

The linked setting is possible for PEEP/Pinsp and for RR/Ti.

Linking PEEP/Pinsp

1 Touch the therapy control PEEP (A) or

Pinsp (B); the color turns to yellow.

The Link (C) button is displayed.

2 Touch the Link (C) button.

Page 36

Operating Concept

The therapy control of the other linked parameter to be linked (Pinsp or PEEP) turns yellow.

3 Turn the rotary knob to set the value for PEEP

or Pinsp. The other value is also automatically changed so that the difference in pressure remains constant.

4 Press the rotary knob to confirm the value.

Both therapy controls turn dark green.

Linking RR/Ti

Setting RR and Ti is effected analogously to the linked setting of PEEP or Pinsp. The I:E ratio re- mains constant. If the respiratory rate is increased, the inspiratory time is reduced. If the inspiratory time is increased, the respiratory rate is reduced.

Additional information

If a condition is reached in which a parameter cannot be changed anymore when setting linked parameters, Babylog VN500 displays a corresponding message in the message field (D).

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 37

Preparation

Safety information on preparation . . . . . . . . 38

Preparing Trolley 2 - 90 cm . . . . . . . . . . . . . . 38

Safety information on the trolley. . . . . . . . . . . . 38

Connecting the universal holder with

standard rail to the trolley . . . . . . . . . . . . . . . . . 39

Connecting the humidifier holder to the

trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Securing accessories to the standard rail. . . . . 39

Securing the compressed air cylinders to

the trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Preparing Infinity C500 . . . . . . . . . . . . . . . . . 41

Positioning Infinity C500. . . . . . . . . . . . . . . . . . 41

Adjusting the position of Infinity C500 . . . . . . . 41

Connecting system cables . . . . . . . . . . . . . . . . 41

Using the MEDIBUS protocol . . . . . . . . . . . . . . 43

LAN and USB interfaces of Infinity C500 . . . . . 43

Preparation

Preparing Babylog VN500 . . . . . . . . . . . . . . . 44

Preparing the Infinity ID neonatal expiratory

valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Safety information for the use of HMEs,

bacterial filters and breathing circuits . . . . . . . . 45

Preparing the breathing gas humidifier. . . . . . . 46

Attaching breathing hoses . . . . . . . . . . . . . . . . 47

Installing a neonatal flow sensor . . . . . . . . . . . 48

Replacing the neonatal flow sensor insert . . . . 49

Installing a CO Connecting the electrical mains power

supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Power supply unit PS500 . . . . . . . . . . . . . . . . . 51

Failure of the electrical power supply . . . . . . . . 52

Power supply of the gas supply unit GS500. . . 52

Connecting the gas supply . . . . . . . . . . . . . . . . 52

Connecting the nurse call . . . . . . . . . . . . . . . . . 53

Closing the flaps at the side of the device . . . . 54

Transportation of patients within the

hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 37

2 cuvette and CO2 sensor. . . . . 49

Page 38

Preparation

Safety information on preparation

WARNING Before each use, reprocess the device and all

accessories in accordance with the Instructions for Use, see "Reprocessing list" on page 202. Note the hospital hygiene regulations!

WARNING The device must not be tilted more than 10°!

Failure to observe this may result in the device toppling over. Danger of damage to device or personal injury!

WARNING Securely mount Babylog VN500. Check for se-

cure fit. Danger of damage to device or personal injury!

Preparing Trolley 2 - 90 cm

WARNI NG Do not place any containers with liquid on or

above the device! Penetrating liquid may impair the correct functioning of the device or damage the device and endanger the patient!

WARNI NG Failure to observe the permitted maximum

load and weight distribution may result in the device toppling over. Danger of damage to device or personal injury! Observe the permitted maximum load and weight distribution, see "Maximum load" on page 228.

CAUTION

When parking the device, lock all the double castors of the trolley and check that the brakes are working properly.

Safety information on the trolley

WARNING Do not use the trolley in the event of visible

damage, e.g., damaged double castors! Contact DrägerService.

WARNING Do not lean, press, push or pull against the

trolley above the marking points on the trolley. The trolley could topple over.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

CAUTION

Connect all devices securely to the trolley. Check for secure fit. Danger of damage to device or personal injury!

Page 39

Preparation

Front of the trolley

Connecting the universal holder with standard rail to the trolley

Attach the universal holder with standard rail to the front of the trolley.

1 Unscrew the adjusting screw (A) completely.

2 Attach the right-hand side of the universal hold-

er to the right-hand side of the rail (B). Make sure that the catch of the universal holder is completely behind the alignment aid.

3 Align the universal holder (C) horizontally and

press the left-hand side of the universal holder onto the left-hand side of the column.

4 Tighten the adjusting screw (A). Make sure that

the catch of the universal holder is completely behind the alignment aid.

5 Check that the universal holder is fixed

securely.

Connecting the humidifier holder to the trolley

The humidifier holder is attached to the front of the trolley. The humidifier holder can be fastened on the left or right-hand side of the trolley column. The attachment of the humidifier holder on the righthand side is shown.

049

192

1 Hold the humidifier holder at the desired height

on the guide (A) of the trolley column.

2 Turn the clamping screw (B) to the left until the

base (C) fits into the guide of the trolley column.

3 Turn the clamping screw (B) to the right until the

humidifier holder is secured firmly in the guide.

4 Move the standard rail (D) to the desired posi-

tion.

Securing accessories to the standard rail

Adjusting the height of the universal holder

1 Unscrew the adjusting screw (A).

2 Adjust the height of the universal holder (C).

3 Align the universal holder horizontally.

4 Retighten the adjusting screw (A).

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 39

Secure the accessories, e.g., breathing gas humidifier or medication nebulizer, to the standard rail. Observe the maximum load! See chapter Technical Data, "Maximum load" on page 228.

Page 40

Preparation

Securing the compressed air cylinders to the trolley

Only available with the option cylinder holder

WARNING Attach the compressed air cylinders using

both Velcro fasteners securely to the trolley. Otherwise there is a risk of the trolley toppling over. Danger of damage to device or personal injury!

WARNING Have the height of the upper holder adjusted

to the respective compressed air cylinders by trained service personnel. The height must be adjusted so that the top half of the compressed air cylinders are secured by the Velcro strip. Otherwise there is a risk of the trolley toppling over. Danger of damage to device or personal injury!

WARNING The length of the Velcro fasteners must match

the diameter of the compressed air cylinders to ensure that the Velcro fasteners can hold the cylinders securely. Have an appropriate Velcro strip fitted by trained service personnel if necessary. This is essential to ensure that the compressed air cylinders are properly secured.

CAUTION

Not every combination of compressed air cylinder diameter and length can be secured. When used in combination with a pressure reducer, the compressed air cylinder must not come into contact with the console of the trolley. The maximum diameter is 176 mm (6.93 inches) when the base of the compressed air cylinder is resting completely on the base plate of the lower holder or is semispherical in shape.

1 Place the cylinders into the mountings on the

trolley.

2 Secure each cylinder with 2 Velcro fasteners

(A).

3 Secure the compressed gas hoses by hanging

them over the hose hooks (B).

Compressed air cylinders with the following dimensions can be secured:

Diameter: 80 to 176 mm (3.15 to 6.93 inches)

Length: 420 to 760 mm (16.54 to 29.92 inches)

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

193

CAUTION

Position the compressed air cylinders fitted with pressure reducers in such a way to prevent the pressure reducers from being damaged during transport. The lower part of the trolley is designed to protect against collisions. Take particular care when the compressed air cylinders being used are too large.

Page 41

Preparing Infinity C500

Preparation

Positioning Infinity C500

Infinity C500 is suitable for positioning on the trolley or on a standard rail.

Positioning Infinity C500 on the trolley

1 Hook the Infinity C500 holder (A) into the

mounting (B) on the trolley.

2 Tighten the locking screw (C).

3 Make sure that Infinity C500 is securely at-

tached to the trolley.

Positioning Infinity C500 on a standard rail

When Infinity C500 is connected to the trolley:

1 Unscrew the locking screw (C).

2 Lift Infinity C500 out of the mounting (B) on the

trolley.

3 Hook Infinity C500 into the standard rail.

4 Tighten the locking screw.

5 Make sure that Infinity C500 is securely at-

tached to the standard rail.

Adjusting the position of Infinity C500

Tilting the position of Infinity C500

Infinity C500 can be tilted down and up.

1 Press and hold the tilt release button (A).

010

2 Tilt Infinity C500 to the desired working position.

3 Release the button and make sure that it en-

gages securely.

Turning Infinity C500

Infinity C500 can be turned by a maximum of 180° to the left or 90° to the right.

z Turn to the desired working position.

Connecting system cables

The system cable is connected to Infinity C500 and to Babylog VN500. The system cable is fixed in a clamp.

011

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 41

Page 42

Preparation

Connecting the system cable to Infinity C500

1 Unscrew the cover from the socket (A).

2 Insert the system cable connector (B) into the

socket (A). Ensure that the connector is inserted with the correct orientation.

3 Screw the cover back on.

Connecting the system cable to Babylog VN500

1 Open the flap on the left-hand side of

Babylog VN500.

2 Route the system cable between

Babylog VN500 and the handle.

4 Insert the system cable connector (E) into the

socket until the connector audibly clicks into

place.

5 Insert the protective sleeve (C) into the protec-

tive plate (F) at the same time.

6 Turn the protective sleeve (C) by approx. 90°

until the protective sleeve clicks into place. The

cable is secured.

7 Close the left-hand flap.

Disconnecting the system cable from Babylog VN500

018003

1 Push the locking mechanism on the connector

(E) backwards and pull out the connector.

2 Turn the protective sleeve (C) by approx. 90°

and pull it out of the protective plate (F).

Fixing the system cable in the clamp (G)

3 Clip the protective sleeve (C) immediately after

the connector (E) onto the system cable (D). Align the protective sleeve so that the slots of the protective sleeve are facing downwards and upwards.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

188

1 Open the clamp cover (H).

2 Place the system cable into the clamp. Keep the

cable length short between the clamp and

Babylog VN500.

3 Close the clamp cover (H) and engage. Ensure

that the cover engages securely.

Removing the system cable from the clamp

1 Open the clamp cover.

2 Remove the cable from the clamp.

3 Close the clamp cover and engage.

Page 43

Preparation

Using the MEDIBUS protocol

NOTE

All transferred data is for information only and should not be used as basis for diagnostic or therapeutic decisions.

MEDIBUS is a software protocol for the transfer of data between Babylog VN500 and an external medical or non-medical device (e.g., patient monitors or computers for data management systems).

The combination of Babylog VN500, Infinity C500 and the external device must comply with the requirements of Directives IEC/EN 60601-1-1 and IEC/EN 60601-1-2.

Additional information

"MEDIBUS for Evita Infinity V500 and Babylog VN500" (9039527)

"Dräger RS MEDIBUS Protocol Definition" (9028258)

Connecting an external device for using MEDIBUS

Configuring the interface

A description is given in chapter "Configure interfaces" on page 163.

LAN and USB interfaces of Infinity C500

Use of LAN interfaces (A) of Infinity C500 is only permitted for service purposes.

The USB interfaces (B) should only be used for connecting a USB storage media or a USB SIM card reader.

WARNING Do not simultaneously touch the connectors

of the interfaces and the patient. Danger of electrical shock.

007

z Connect an external device to the interface

COM 1, COM 2 or COM 3 (A) of

Infinity C500. Use MEDIBUS cable 8416326.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 43

195

Page 44

Preparation

Preparing Babylog VN500

Preparing the Infinity ID neonatal expiratory valve

WARNING Only use properly reprocessed expiratory

valves which have been sufficiently dried. Otherwise the proper functioning of the device may be impaired and the patient endangered.

The expiratory valve is mounted and then inserted into the ventilation unit.

Mounting the expiratory valve

1 Fit the diaphragm (A) onto the edge of the expi-

ratory valve housing. Make sure that the diaphragm is fitted properly.

2 If the silencer (B) has been removed, fit the si-

lencer.

040006

3 Fit the collection container for the water trap

(C).

Open the flap

Open the flap (D) before inserting the expiratory valve.

329

z Lift the flap (D) by the lower edge and pivot it up-

wards.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 45

Preparation

Insert the expiratory valve into the ventilation unit

1 Turn the locking ring (E) as far as possible to the

left.

2 Push the expiratory valve into the fitting.

3 Turn the locking ring (E) as far as it will go to the

right until it clicks audibly into place.

4 Check that it is properly secured by gently pull-

ing on the expiratory valve.

Close the flap

When the expiratory valve and the silencer are fitted, tilt the flap (D) downwards.

Leave the flap closed during ventilation.

Safety information for the use of HMEs, bacterial filters and breathing circuits

CAUTION

Additional components in the breathing circuit such as bacterial filters or HME increase the dead space and result in the increase of compliance or resistance. The use of additional components therefore requires particular care and monitoring!

Additional components in the breathing circuit can increase the inspiratory and expiratory breathing resistance and exceed standard requirements. Examples: Inspiratory and expiratory bacterial filters, HMEs.

073006

Babylog VN500 is designed to minimize the patient's work of breathing. Operation does therefore not require inspiratory or expiratory bacterial filters. The use of bacterial filters or HMEs requires particular care and monitoring by the user. Especially during medication nebulization and humidification, the resistance of the expiratory bacterial filter may increase gradually.

A higher breathing resistance leads to a greater work of breathing and trigger effort. Under unfavorable conditions, this can lead to an undesirable intrinsic PEEP, which can be recognized by the fact that the expiratory flow does not return to "baseline" at the end of expiration. If the PEEP is unacceptably high, this is indicated by an alarm. The measured PEEP is then more than 4 mbar (4 cmH above the set PEEP. If the end-expiratory flow is high, the alarm threshold increases to a measured PEEP value of up to 12 mbar (12 cmH

A breathing resistance in the patient connection cannot be monitored directly by Babylog VN500. For this reason:

z Before starting ventilation, determine in standby

mode inspiratory and expiratory breathing resistance in the breathing circuit by means of the breathing circuit check.

z Check the condition of the patient and the de-

vice's measured values for volume and resistance more frequently.

2O).

2O)

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 45

Page 46

Preparation

z Observe the Instructions for Use for the HMEs,

bacterial filters and breathing circuits in use.

Preparing the breathing gas humidifier

z Prepare the Fisher & Paykel MR 850 breathing

gas humidifier in accordance with the corresponding Instructions for Use.

CAUTION

Do not use an HME together with a breathing gas humidifier! This can lead to an increased breathing resistance.

Connecting the Fisher & Paykel MR 850 breathing gas humidifier

The breathing gas humidifier can be connected in the following ways: – on the standard rail of the universal holder – on the humidifier holder of the trolley – on the humidifier holder on the side rail

Connecting the breathing gas humidifier on the universal holder with standard rail

Connecting the breathing gas humidifier to the humidifier holder of the trolley

185194

z Connect the breathing gas humidifier to the hu-

midifier holder of the trolley.

z Tilt the breathing gas humidifier into the correct

position.

Connecting the breathing gas humidifier to the humidifier holder on the side rail

If a compressor is used on the trolley, use humidifier holder on the side rail. The holder can be connected to the left-hand or right-hand side of device.

z Clamp the breathing gas humidifier to the stan-

dard rail (A) under the ventilation unit and screw firmly into place.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

1 Hook the holder on the lateral standard rail (B)

030

of Babylog VN500. Position the holder on the

standard rail so that the flap at the side of the

unit can still be opened.

2 Turn the clamping screw (C) until the holder is

fixed securely on the rail.

3 Attach the breathing gas humidifier to the mount

(D).

Page 47

Preparation

Additional information

For the order numbers of the holder for the breathing gas humidifier, see the list of accessories.

Attaching breathing hoses

WARNING Do not use antistatic or conductive breathing

hoses. The use of these materials increases the danger of electric shock to the patient and of fire in an oxygen-enriched environment.

CAUTION

The sterile packaging of disposable articles should only be opened immediately before use. Otherwise there is a risk of infection.

1 Hang the hinged arm (A) on the lateral standard

rail of Babylog VN500 and tighten the screws. Depending on the desired position of the device in relation to the bed, the hinged arm can be fitted to either side of Babylog VN500.

CAUTION

Do not reverse the connections for inspiration (B) and expiration (C). Humidification is ineffective if the connections are reversed.

3 Turn the inspiratory port and the expiratory port

in the direction of hoses.

A water trap is required for the Fisher & Paykel MR 850 breathing gas humidifier depending on the breathing circuit used.

4 If a water trap is required, install the water trap

(D) in a vertical position.

5 Connect the Y-piece (E) to the breathing hoses.

6 Insert the Y-piece or the breathing hoses in the

opening of the hinged arm.

Using the Infinity ID breathing circuit

Babylog VN500 recognizes the use of an Infinity ID breathing circuit. The message Infinity ID Breath- ing Circuit detected is displayed in the header bar.

The following Infinity ID functions are supported: – Detection of reversed hoses – Detection of non-compliance with the patient

Setting the breathing circuit

Babylog VN500 supports the user in selecting the breathing circuit on the page Start/Standby > Br.

2 Connect breathing hoses to the inspiratory port

(B) and to the expiratory port (C).

circuit/ Humidifier.

057

z Set the breathing circuit according to the patient

category.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 47

Page 48

Preparation

Whenever the breathing hoses or the breathing gas humidifier have been changed

z Check the breathing circuit, see "Performing the

breathing circuit check" on page 66.

Additional information

For the order numbers of the breathing circuits and the hinged arm, see the list of accessories.

Installing a neonatal flow sensor

The following neonatal flow sensors are available: – Neonatal flow sensor ISO 15 (8411130) – Neonatal flow sensor Y-piece (8410185)

Installing an ISO 15 neonatal flow sensor (8411130)

Installing a neonatal flow sensor Y-piece (8410185)

301302

1 Connect Y-piece with integrated neonatal flow

sensor (D) to the breathing hoses.

2 Connect plug (E) of the flow sensor cable to the

flow sensor.

Further procedure for both neonatal flow sensors

3 Position patient connector of the Y-piece

about 45° downwards to prevent condensation

from forming on the neonatal flow sensor.

4 Route the cables along the breathing hoses to

the device.

1 Insert the neonatal flow sensor (A) into the pa-

tient connector of the Y-piece (B).

2 Connect plug (C) of the flow sensor cable to the

flow sensor.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

300

5 Insert the connector (F) of the flow sensor cable

into the socket (G) at the rear of

Babylog VN500.

Page 49

Additional information

For the order numbers of the neonatal flow sensor, see the list of accessories.

Replacing the neonatal flow sensor insert

Preparation

If the Babylog VN500 displays the alarm message Neonatal flow sensor?, the insert of the neonatal flow sensor must be replaced.

1 Disconnect the flow sensor cable (A) from the

neonatal flow sensor.

2 Press the buttons (B) on both sides while pulling

the insert (C) out of its housing.

3 Push in new insert (C) until it engages. The two

markings (D) must line up.

4 Connect plug (A) of the flow sensor cable to the

neonatal flow sensor.

5 Calibrate the neonatal flow sensor,

see page 129.

Installing a CO2 cuvette and CO2 sensor

1 Insert the cuvette (A) into the patient connector

of the Y-piece. The cuvette windows are facing to the side.

2 Fit the CO

is facing towards the device.

303

3 Insert the connector of the CO

the socket (D) at the rear of Babylog VN500.

4 Selecting the cuvette type, see page 131.

2 sensor (B) on the cuvette. The cable

2 sensor (C) into

054180

For small premature infants, do not carry out CO2 measurements because the CO cantly increases the dead space.

2 cuvette signifi-

Additional information

"Calibrating the CO

For the order numbers of the accessories for the CO

2 application, see the list of accessories.

2 sensor" on page 131.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 49

Page 50

Preparation

Connecting the electrical mains power supply

If the power supply unit PS500 is connected, see "Power supply unit PS500" on page 51.

Connecting the electrical mains power supply to Babylog VN500

The mains power must conform with the voltage range specified on the rating plate (100 V to 240 V, 50/60 Hz).

1 Plug the appliance socket (A) onto the appli-

ance connector (B).

2 Position the power cable (C) in the clamp (D).

Fit the clamp into the housing (E). Tighten the screw (F) (stress relief).

Checking the toggle switch on Babylog VN500

CAUTION

Do not press the toggle switch during ventilation.

Prerequisite: The flap on the left-hand side of the device is opened.

182

z Check whether the toggle switch (G) is set to

(on).

z If the toggle switch is set to (off), set the tog-

gle switch to (on).

WARNI NG Do not simultaneously touch the connectors

of the interfaces (H) and the patient. Danger of electrical shock.

002186

Electricity supply from the internal battery

Babylog VN500 is provided with an internal battery to ensure that operation of the device can continue for at least 30 minutes (provided that the battery is fully charged and new) following failure of the mains power supply.

z Insert the mains plug into the mains power

socket.

The LED on Infinity C500 lights up green.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

CAUTION

The internal battery is intended exclusively for emergency use and not for normal operation! It is essential to operate the device with mains power again as soon as possible after switching over to operation with the internal battery.

Page 51

Additional information

For more information on the internal battery, see "Mains power supply / DC power supply" on page 105.

If the gas supply unit GS500 is connected, see "Power supply of the gas supply unit GS500" on page 52.

Preparation

Power supply unit PS500

Connecting the electrical mains power supply to PS500

The mains power must conform with the voltage range specified on the rating plate: – 100 to 127 V at 50 Hz or 60 Hz – 220 to 240 V at 50 Hz – 220 to 240 V at 60 Hz with additional equipoten-

tial bonding

z Insert the mains plug into the mains power

socket.

The LED on PS500 lights up green.

Checking the toggle switch on PS500

CAUTION

Do not press the toggle switch during ventilation.

z Check whether the toggle switch (A) is set to

(on).

z If the toggle switch is set to (off), set the tog-

gle switch to (on).

z Check the toggle switch on Babylog VN500,

see "Checking the toggle switch on Babylog VN500" on page 50

Electrical power supply from the internal batteries

PS500 is provided with internal batteries to ensure, following failure of the mains power supply, that the operation of the Workstation Neonatal Care can continue for at least 100 minutes (provided the batteries are fully charged and new and ventilation is typical).

CAUTION

The internal batteries are intended exclusively for emergency use and not for normal operation! It is

337

essential to operate the device with mains power again as soon as possible after switching over to operation with the internal batteries.

For more information on the power supply unit, see PS500

See "Power supply unit PS500" on page 107.

335

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 51

Page 52

Preparation

Failure of the electrical power supply

If the power supply fails and the internal batteries of Babylog VN500 and PS500 are fully discharged, then Babylog VN500 generates a power failure alarm. The ventilation settings and the alarm limits remain saved even in the event of a mains power failure.

Power supply of the gas supply unit GS500

If Babylog VN500 is equipped with the power supply unit PS500, then the gas supply unit is supplied with power using the power supply unit.

If Babylog VN500 is not equipped with the power supply unit PS500:

z Plug the mains plug of the gas supply unit into

the mains socket.

The LED on GS500 lights up green.

Connecting the gas supply

WARNING Do not bring any oxygen supply components

into contact with oil and grease. Danger of explosion through spontaneous ignition!

WARNING Only use compressed gases approved for

medical use. The compressed gases must be free of dust and oil particles and dry. Otherwise the proper functioning of the device cannot be ensured.

Central gas supply

Prerequisite: The flap on the right-hand side of the device is opened.

1 Screw the compressed gas hose for air to the

connection Air (A) and the O

hose to the O

Babylog VN500.

2 Plug the connectors into the wall outlets for the

central gas supply.

3 Position the compressed gas hoses over the

hose hooks (C).

The gas delivered through compressed gas hoses is used as fresh gas (FRESH GAS).

Additional information

For the order numbers of the compressed gas hoses, see the list of accessories.

2 connection (B) of

2 compressed gas

021

Gas supply from cylinders

If the central gas supply fails or is not available, the gas can be supplied from cylinders.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 53

Additional information

Brown (COM)

Green (NC)

White (NO)

Air supply from a gas supply unit (GS500), see "Gas supply unit GS500" on page 99.

Connecting the nurse call

Preparation

The nurse call is used for transmitting high priority alarm messages (warning) to a central hospital alarm system.

Safety information for using the nurse call

CAUTION

A fault in any of the components in the link between the nurse call and the central hospital alarm system (e.g., in the unit's electronics for nurse call, in the unit's power supply or in the alarm generator of the central hospital alarm system) may result in failure of the nurse call.

CAUTION

Connection of a nurse call does not relieve staff of their duty to check the monitoring on the device screen at regular intervals. Screen displays must be checked regularly.

CAUTION

All alarms of Babylog VN500 must be checked regularly even when the nurse call is connected. Do not use nurse call as the sole source of alarm information!

029022

As soon as Babylog VN500 signals an alarm, the connection between the white cable and the brown cable (NO and COM) is closed and the nurse call is activated.

Connecting the nurse call to the ventilation unit

Prerequisite: The flap on the left-hand side of the device is opened.

Connecting the nurse call to the central alarm

z The nurse call cable must be connected to the

lead to the central alarm station in the hospital by trained service personnel.

1 Plug the nurse call connector (A) into the socket

(B) until it engages audibly.

NOTE

The connector must engage audibly into the socket to ensure all alarm messages are transmitted properly.

2 Check the correct operation of connected nurse

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 53

call system.

Page 54

Preparation

Information on the nurse call

High priority alarm messages (warning) are transmitted to a central alarm station in the hospital. Medium priority (caution) and low priority (note) alarm

Closing the flaps at the side of the device

z Close the lateral flaps of the device after prepa-

ration.

messages are not transmitted.

The nurse call is also activated when the internal acoustic alarm generator in the device is defective.

If, in the event of an alarm, the Audio paused key is pressed, the acoustic alarm on the device and the nurse call are suppressed for 2 minutes.

Additional information

For the order number of the nurse call cable, see the list of accessories.

CAUTION

Keep both lateral flaps on the device closed during operation to prevent accidental actuation of the toggle switch or connections becoming loose.

Transportation of patients within the hospital

023

WARNING The device must not be tilted more than 10°!

Failure to observe this may result in the device toppling over. Danger of damage to device or personal injury!

WARNING The device must not be placed on the bed

while transferring a patient within the hospital. The device could topple over or fall down. Danger of damage to device or personal injury!

WARNING Do not lean, press, push or pull against the

trolley above the marking points on the trolley. The trolley could topple over.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

WARNI NG Do not move trolley faster than at a walking

pace. There is an increased danger of the trolley toppling over at thresholds, uneven surfaces and ramps. Reduce the speed of transport further. Danger of damage to equipment!

WARNI NG Two people are always required to move the

device. Otherwise there is an increased risk of the device toppling over.

WARNI NG Make sure to securely hold onto the handle of

the trolley whenever moving or positioning the device. Otherwise there is an increased risk of the device toppling over.

Page 55

Preparation

WARNING Patient hazard due to discharged batteries.

Only start transporting patients when the batteries are sufficiently charged.

When transporting patients within the hospital, medical staff must ensure that the patient is monitored continuously.

Using Babylog VN500 with a safety bar

CAUTION

During the transportation of patients within the hospital, Babylog VN500 must be used with a safety bar (A) in order to prevent accidental disconnection of the breathing hoses or damage to the inspiratory port and the expiratory port.

Additional information

Air supply from the gas supply unit GS500, see "Gas supply unit GS500" on page 99.

Power supply from the power supply unit PS500, see "Power supply unit PS500" on page 107.

For the order number of the safety bar, see the list of accessories.

020

Increase the toppling stability during the transportation of patients within the hospital

To ensure that the equipment cannot topple over, the accessories must be moved to the most advantageous position:

1 Hinged arm set to minimum deflection.

2 Hoses and cables hooked as close as possible

to the trolley.

3 Humidifier secured to the trolley, not to the lat-

eral rails of Babylog VN500.

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56 Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 57

Getting Started

Safety information on getting started. . . . . . 58

Prerequisites to getting started. . . . . . . . . . . . . 58

Switching on Babylog VN500 and

Infinity C500 . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Select patient . . . . . . . . . . . . . . . . . . . . . . . . . 59

Using the settings of the previous patient. . . . . 59

Admission of a new patient. . . . . . . . . . . . . . . . 59

Selecting the breathing circuit and the

breathing gas humidifier . . . . . . . . . . . . . . . . 62

Check readiness for operation . . . . . . . . . . . 63

Safety information on the system check. . . . . . 63

Starting the system check. . . . . . . . . . . . . . . . . 63

Performing a device check . . . . . . . . . . . . . . . . 63

Performing the breathing circuit check . . . . . . . 66

Getting Started

Selecting Tube or NIV application mode . . . 68

Setting parameters for the tube . . . . . . . . . . . . 68

Select therapy type. . . . . . . . . . . . . . . . . . . . . 69

Start therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Displaying the status of accessories . . . . . . 71

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 57

Page 58

Getting Started

Start

Safety information on getting started

WARNING Ventilation does not take place in standby

mode! The device must only be set to standby mode when no patient is connected to the device. Other settings may jeopardize the patient!

CAUTION

Before using for the first time, the device must remain connected to the mains power supply for at least 4 hours so that the internal battery can be fully charged.

CAUTION

Before using the power supply unit PS500 for the first time, the device must remain connected to the mains power supply for at least 8 hours so that the internal batteries can be fully charged.

CAUTION

Condensation may form when the device is moved from a cold storage location to a warm environment. Do not switch on the device as otherwise its proper functioning may be adversely affected. Wait until the condensation has dried.

Prerequisites to getting started

– Babylog VN500, Infinity C500, PS500 and

GS500 are reprocessed and assembled ready

for operation. – The electrical power supply and the gas supply

must be connected. – The toggle switches Babylog VN500 and

PS500 are set to (on).

Switching on Babylog VN500 and Infinity C500

z Press the (A) button on Infinity C500.

The system is started. The Start dialog is displayed.

Babylog VN500 provides you with two options: – Use settings of previous patient (B) – Admit new patient (C)

017

If the Start dialog is closed via the X (D) button,

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Babylog VN500 adopts the settings of the previous patient.

116

Page 59

If a data loss occurs, the previous settings cannot

Start

Start/Standby

be recovered. The Current patient (B) button is not displayed.

Select patient

Getting Started

Using the settings of the previous patient

Prerequisite: The Start dialog is opened.

z Touch the Current patient (A) button.

The last used patient-related settings including the alarm limits, application mode and device status are restored.

The Start/Standby (B) page is displayed. Babylog VN500 is in standby mode.

The button for starting the therapy (D) is preset for 15 seconds. When the therapy is started, the settings become effective.

Admission of a new patient

For a new patient, Babylog VN500 determines the ventilation parameters’ start-up settings based on the patient category (factory setting) or the body weight. The factory settings for the settings dependent on patient category and weight can be changed in the System setup dialog window.

116092

The patient category or the body weight can only be changed when a new patient is admitted. In the patient category Ped. pat., the body height is entered and from that the ideal body weight is determined. In the Neo. patient category, the body weight is entered directly. The weight-dependent setting for a new patient is only possible after selecting Weight in the System setup dialog window.

The alarm limit start-up settings are recalculated according to the customized system configuration.

When a new patient is admitted, the settings and trend data of the previous patient are deleted.

Babylog VN500 displays the ventilation parameter start-up settings (C).

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Page 60

Getting Started

Start

125

Start/Standby

Prerequisite: The Start dialog is opened.

1 Touch the following button for a new patient:

– New Ped. pat. (A) for new pediatric patients – New Neo. (B) for new neonatal patients

The respective button turns yellow.

2 Confirm with the rotary knob.

The Start/Standby page is displayed. Babylog VN500 is in standby mode.

Ventilation parameter start-up settings by patient category

The Start/Standby page (C) contains the buttons for the patient category:

The ventilation parameters displayed in the lower part of the page (F) are the start-up settings for the selected patient category.

Determining the start-up settings can take up to 5 seconds. No entries can be made during this time.

Ventilation parameter start-up settings by body height/body weight

116

Prerequisite: In the System setup dialog window, the Weight function was configured and a new patient was admitted.

In the Ped. pat. patient category, the Start/Standby page (C) contains the button for body height (G) and the field for the ideal body weight (H).

New Ped. pat. (D)

New Neo. (E)

1 Touch the button for the desired patient

category (D) or (E).

2 Confirm with the rotary knob.

106

1 Touch the button for the body height (G).

2 Set the body height by turning the rotary knob

and push to confirm.

Babylog VN500 determines the start-up values for VT, RR, Slope and Flow trigger based on the ideal body weight calculated from the body height. The values for VT and RR are displayed in the lower part of the page (F). The other ventilation parameters displayed in the lower part of the page are startup settings for the selected patient category.

In the Neo. patient category, the patient’s body weight is set directly. The Start/Standby page (C) contains the button for this start-up body weight (I).

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 61

1 Touch the button for the start-up body weight (I).

Start/Standby

2 Using the rotary knob, set the start-up body

weight and confirm the value.

The button for the current body weight (J) is displayed. After the patient has been admitted, the current body weight corresponds to the start-up body weight. If the current body weight is different from the start-up body weight:

3 Touch the button for the current body weight (J).

4 Using the rotary knob, set the current body

weight and confirm the value.

Babylog VN500 determines the start-up values for VT, RR, Slope and Flow trigger based on the start-up body weight. The values for VT and RR are displayed in the lower part of the page (F). The other ventilation parameters displayed in the lower part of the page are start-up settings for the selected patient category.

By setting the current body weight, it is possible to display the measured values relative to the body weight, e.g., VT/kg BW.

Determining the start-up settings can take up to 3 seconds. No entries can be made during this time.

Getting Started

Additional information

The configuration for the ventilation parameter start-up values by body height/body weight or by patient category is entered on the System setup > Ventilation > Start settings page. See chapter "Configuring start-up settings for the ventilation parameters" on page 153.

For information on configuring customized alarm limits, see chapter "Setting start-up values for alarm limits" on page 149.

319

For information on starting the therapy, see "Start therapy" on page 70.

Whenever the patient category has been changed

Check the breathing circuit, see "Performing the breathing circuit check" on page 66.

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Page 62

Getting Started

Start/Standby

Selecting the breathing circuit and the breathing gas humidifier

The breathing circuit and the breathing gas humidifier can only be selected in standby mode.

1 Touch the Start/ Standby... button in the main

menu bar.

2 Touch the Br. circuit/ Humidifier (A) tab.

The page for selecting the breathing circuit and the breathing gas humidifier is displayed.

Selecting the breathing circuit from the selection list

3 Touch the (B) button.

4 Select the breathing circuit used from the selec-

tion list.

5 Confirm with the rotary knob.

To help with the selection, the selected breathing circuit is displayed as a detailed representation (C) and also described as text (D).

Babylog VN500 automatically selects the corresponding humidification type based on the breathing circuit (E) selected. Some breathing circuits provide the selection of HME/Filter and None.

If the breathing circuit used is not included in the selection list

1 Touch the (B) button.

2 Select Other from the selection list.

3 Confirm with the rotary knob.

4 Select the humidification type (E):

– Active humid., exp. unheated

– Active humid., exp. heated

– HME/Filter

–None

Press the corresponding button.

Infinity ID Breathing circuits

When using Infinity ID breathing circuits, the connected hose type as well as the corresponding humidification type are set automatically.

If the message Infinity ID Breathing Circuit de-

080

tected is not displayed when connecting an Infinity ID breathing circuit, then use a different Infinity ID breathing circuit. If the message is still not displayed, replace the Infinity ID neonatal expiratory valve or inspiratory valve.

Whenever the breathing circuit or the breathing gas humidifier have been changed:

z Check the breathing circuit, see "Performing the

breathing circuit check" on page 66.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 63

Check readiness for operation

Start/Standby

Getting Started

The system check consists of the device and breathing circuit check.

Safety information on the system check

WARNING The device must not be put into operation if a

fault is discovered during the device and breathing circuit check! Patient hazard!

CAUTION

The device and breathing circuit check must be carried out before use on the patient in order to confirm that Babylog VN500 is operating correctly.

Starting the system check

The system check is only possible in standby mode.

1 Touch the Start/ Standby... button in the main

menu bar.

2 Touch the System check (A) tab.

Performing a device check

The device check is only possible in standby mode.

Keep test lung ready

Pediatric test lung (8409742) for the pediatric and neonatal breathing circuit

The test lung must only be inserted into the patient connector of the Y-piece after instruction by Babylog VN500.

Starting the device check

Prerequisite: The System check (A) page is opened.

1 Touch the Device check (B) tab.

Babylog VN500 displays the individual test steps in a list (C). The size of the list depends on the available applications.

2 Touch the Start (D) button.

3 Confirm with the rotary knob.

Babylog VN500 displays the date, time and results of the last system check on the Overview (B) page.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 63

101

102

Page 64

Getting Started

Start/Standby

Test steps in the device check

In the device check the following test steps are carried out: – Auxiliary acoustical alarm (test of auxiliary

alarm/power failure alarm)

– Breathing circuit connection (visual inspection

of breathing circuit)

– Inspect humidifier (visual inspection of breath-

ing gas humidifier)

2 sensor calibration

–CO – Neonatal flow sensor: Calibration – Neonatal flow sensor: Measurement – Test lung connection – Gas supply sensors: Calibration

2 supply

–O – Air supply – GS500 (gas supply unit) (if the gas supply unit

function is activated) – Pressure sensor calibration valve – Expiratory valve (expiratory valve check) – Safety valve (safety function check)

2 sensor: Calibration

–O – Medication nebulizer (medication nebulizer

control check)

Device check procedure

Babylog VN500 guides the user in the form of a question/answer dialog through the respective test step. The instruction field (E) displays the questions or instructions how to carry out the test steps.

The questions must be answered by pressing the Yes (F) or No (G) buttons.

The Next test (H) button can be used to skip the test steps.

A test step is also skipped if the necessary prerequisites have not been met.

102

The test steps in the device check are displayed with the following symbols:

Rotating symbol : Active test step

Green dot : Correct result

Red dot : Incorrect result

Colorless dot : Test step not carried out

Repeating test steps in the device check

1 Touch the Repeat (I) button.

2 Confirm with the rotary knob.

All test steps that have not yet been carried out or that were unsuccessful are repeated.

Aborting the device check

1 Touch the Cancel (J) button.

2 Confirm with the rotary knob.

The device check is also aborted when the Device check page is exited. The device check can be

continued when the Device check page is called again.

1 Touch the Repeat (I) button.

2 Confirm with the rotary knob.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 65

Getting Started

Test results

The test results obtained from the device check and the calibration and zero-checking values of the sensors remain stored until the next calibration, even if the device is switched off.

Incorrect test steps and remedies

Errors in the following safety-relevant test steps generate the medium-priority alarm message Device check failed: – Pressure sensor calibration valve – Expiratory valve – Safety valve

The alarm cannot be acknowledged. Do not start ventilation!

Errors in non-safety-relevant test steps or test steps that are not carried out on account of a prerequisite generate the low-priority alarm message Device check incomplete.

The alarm causes and their remedies are displayed on the Current alarms page.

The following table shows the remedies for eliminating the errors during the device check:

Test step Remedy

Auxiliary acoustical

Contact DrägerService.

alarm

2 sensor

calibration

Check whether the

2 sensor is connected.

CO Wait for the CO2 sensor to complete its three-minute warm-up phase. Check whether the

2 sensor or the cuvette

CO are soiled.

Neonatal flow sensor: Calibration

Clean the flow sensor. Keep flow sensor sealed during calibration. Check whether the flow sensor cable is connected.

Test step Remedy

GS500 (gas supply unit)

Check whether the gas connection to the device is kinked. Check whether the data cable is connected.Contact DrägerService.

Gas supply sensors: Calibration

Check whether the compressed gas hoses are connected.

2 supply Check whether the O2 com-

pressed gas hose is connected.

Air supply Check whether the Air com-

pressed gas hose is connected.

Pressure sensor calibration valve

Connect the test lung. Check the breathing circuit for leaks. Check whether the compressed gas hoses are connected. Check whether the expiratory valve is properly engaged.

Expiratory valve Check whether the water

trap is connected. Check whether the expiratory valve is properly engaged.

Safety valve Connect the test lung.

Check the breathing circuit for leaks. Check whether the compressed gas hoses are connected. Check whether the expiratory valve is properly engaged.

2 sensor:

O Calibration

Check whether the compressed gas hoses are connected.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 65

Page 66

Getting Started

Test step Remedy

Medication nebulizer

Check whether the compressed gas hoses are connected.

z Eliminate the causes of the error and repeat the

test step.

z If the test step is still incorrect, contact

DrägerService.

Inspiratory calibration

Inspiratory calibration takes approx. 2 minutes. This test step must be carried out every 3 months. The test step can be skipped with No and is displayed as "successfully completed" (green dot).

If the test step is skipped with Next test, the test step is displayed as "not carried out" (colorless dot).

If a complete calibration is necessary after 3 months and the test step is skipped with Next test, the test step is displayed as "failed" (red dot).

Calibrating the O

The O

2 sensor is calibrated during each device

check. The regular calibration of the O

2 sensor

2 sensor en-

sures the specified accuracy.

If the test step is skipped with Next test and the O2 sensor is not calibrated for 3 months, the accuracy of the O eter field for FiO

2 sensor will be reduced. In the param-

2 a question mark appears next to

the measured value. After calibration during the device check the sensor will work again with full accuracy. The measured value is displayed in the parameter field.

If the test step is skipped with Next test, the test step is displayed as "not carried out" (colorless dot).

If Babylog VN500 requires the O

2 sensor to be

calibrated and the test step is still skipped with Next test, the test step is displayed as incorrect (red dot).

CAUTION

If the quality of the oxygen from the central gas supply is not sufficient, calibrate the O

2 sensor

with a corresponding calibration gas (100 % O2). Otherwise this may result in an incorrect calibration.

After the device check

z Performing the breathing circuit check.

Performing the breathing circuit check

The check is only possible in standby mode.

The breathing circuit check must be performed: – Device check – after changing the breathing circuit – after changing the breathing gas humidifier – after changing the patient category

Test steps during the breathing circuit check

The following test steps are carried out: – Leakage – Compliance – Insp. Resistance – Exp. Resistance

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 67

Getting Started

Start/Standby

Starting the breathing circuit check

Prerequisite: The System check (A) page is opened.

1 Touch the Breathing circ. check (B) tab.

The values of the last test are displayed (C). If a valid measurement has not yet taken place, the standard values are displayed.

2 Touch the Start (D) button.

3 Confirm with the rotary knob.

4 When requested by Babylog VN500 in the in-

struction field (E): seal the Y-piece or the neonatal flow sensor Y-piece, e.g., with a sterile glove. Confirm with OK (F).

5 When requested, open the Y-piece or remove

the neonatal flow sensor Y-piece. Confirm with OK (F).

The current leakage flow is displayed continuously throughout the test. A leakage flow up to 300 mL/min at a pressure of 60 mbar (60 cmH is permissible.

After the leak test, Babylog VN500 determines the compliance and the inspiratory and expiratory resistance of the breathing circuit.

When changing the breathing circuit and type of humidifier, Babylog VN500 automatically resets the values for hose compliance and hose resistance to default values. When using Infinity ID breathing circuits, the default values of the breathing circuit detected are used. The leakage measurement becomes invalid.

When the patient category is changed, the breathing circuit that was last used in this category is selected and the corresponding values for hose compliance and hose resistance are used.

The leakage measurement becomes invalid when a new patient is admitted to the same patient category. The values for hose resistance and hose compliance are retained.

It is recommended to perform the breathing circuit check before commencing patient ventilation with a newly started device.

Aborting the breathing circuit check

103

1 Touch the Cancel (G) button.

2 Confirm with the rotary knob.

The leakage measurement becomes invalid. The values for hose resistance and hose compliance are reset to the default values.

2O)

Repeating the breathing circuit check

If the breathing circuit is changed after the breathing circuit check, the humidification type or the patient category is changed, the breathing circuit check will have to be repeated.

The breathing circuit check is also necessary when using Infinity ID breathing circuits.

103

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Getting Started

Start/Standby

C D

Start/Standby

Selecting Tube or NIV application mode

Babylog VN500 can change between non-invasive ventilation and tube ventilation.

The application mode can only be selected in standby mode.

1 Touch the Start/ Standby... button in the main

menu bar.

2 Touch the Tube/NIV (A) tab.

3 Touch the Tube (B) or NIV (C) button.

4 Confirm with the rotary knob.

Observe the information on changing the application mode!

Setting parameters for the tube

The tube inside diameter and tube type can be entered for the following functions: – Display of Ptrach, independent of ATC, – Improvement of leakage compensation – Measurement of resistance R and

compliance C

When the tube inside diameter and tube type are entered, the measured value R corresponds with the patient resistance. When the tube inside diameter and tube type are not entered, the measured value R corresponds with the total resistance.

Prerequisite: The Tube/NIV (A) page is opened. The Tube application mode has been selected.

113

CAUTION

Application mode NIV must not be activated with intubated patients.

WARNING Alarm limits and ventilation settings must be

checked or set again in order to ensure complete monitoring of ventilation after changing from NIV application mode to Tube application mode.

Additional information

For information on using the NIV application mode for non-invasive ventilation, see "NIV – Non-invasive ventilation" on page 82.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

113

Activating or deactivating the calculation of tracheal pressure

1 Touch the appropriate button (B).

2 Confirm with the rotary knob.

If ATC is switched off, the calculation of tracheal pressure is always deactivated when a new patient is admitted.

Page 69

Getting Started

Start/Standby

Selecting the tube type

In the Neo. patient category, this selection is not available.

1 Touch the appropriate button (C).

2 Confirm with the rotary knob.

Select therapy type

Babylog VN500 can choose between the therapy types Ventilation and O

The therapy type can only be changed in standby mode.

1 Touch the Start/ Standby... button in the main

menu bar.

The Start/Standby (A) page is displayed.

2 Therapy.

Entering the inside diameter

1 Touch the (D) button.

2 Set the value by turning the rotary knob and

push to confirm.

126

2 Touch the Ventilation (B) or O

2 Therapy (C)

button.

3 Confirm with the rotary knob.

Additional information

2 Therapy, see page 100.

Setting ventilation, see page 74.

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Page 70

Getting Started

Start/Standby

Start therapy

Before using on the patient

z Carry out a system check to ensure that

Babylog VN500 is operating correctly,

seepage63.

z Check the therapy settings: For information on

setting alarm limits, see page 114. Setting ven-

tilation modes and ventilation parameters, see

"Setting ventilation" on page 74.

Starting ventilation or O

2 therapy

1 Touch the Start/ Standby... button in the main

menu bar.

The Start/Standby (A) page is displayed. The Start (B) remains preset for 15 seconds.

Additional information

The page for the ventilation settings can be opened with the Ventilation settings... (C) button.

2 Confirm with the rotary knob.

Babylog VN500 starts the therapy with the set ventilation parameters. The main screen for ventilation or O

2 therapy is displayed.

When the Start button is no longer preset

After 15 seconds the Start button is no longer preset.

1 Touch the Start (B) button.

2 Confirm with the rotary knob.

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Page 71

Displaying the status of accessories

1 Touch the Start/ Standby... button in the main

menu bar.

2 Touch the Accessory status tab.

Babylog VN500 displays the time until it is recommended to exchange the accessories.

Sterilization of the Infinity ID expiratory valve or inspiratory valve may gradually impair the operation of RFID transmission. This may mean that Infinity ID breathing circuit functions may not work or may no longer work reliably. The status for the Infinity ID accessories is not displayed.

Additional information

The time for the exchange interval can be configured on the System setup > Exchange intervals page. See "Exchange intervals" on page 161.

Getting Started

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72 Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

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Operation

Setting ventilation . . . . . . . . . . . . . . . . . . . . . 74

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Opening the Ventilation settings dialog window 74

Selecting ventilation modes . . . . . . . . . . . . . . . 74

Setting ventilation parameters . . . . . . . . . . . . . 75

Basic settings for ventilation. . . . . . . . . . . . . . . 76

Additional settings for ventilation . . . . . . . . . . . 79

NIV – Non-invasive ventilation . . . . . . . . . . . 82

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Safety information on using NIV. . . . . . . . . . . . 82

Selecting the NIV application mode . . . . . . . . . 82

Starting NIV ventilation . . . . . . . . . . . . . . . . . . . 83

Setting ventilation parameters for NIV . . . . . . . 83

Monitoring during NIV. . . . . . . . . . . . . . . . . . . . 84

Display curves and measured values. . . . . . 85

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Changing the screen view . . . . . . . . . . . . . . . . 85

Changing the display of monitoring fields. . . . . 85

Evaluating loops . . . . . . . . . . . . . . . . . . . . . . . . 86

Freeze waveforms . . . . . . . . . . . . . . . . . . . . . . 87

Smart Pulmonary View. . . . . . . . . . . . . . . . . . . 88

Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Fitting the Aeroneb Pro nebulizer . . . . . . . . . . 97

Gas supply unit GS500 . . . . . . . . . . . . . . . . . 99

2 Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Safety information on O Preparing O Switching on O Setting FiO Switching off O

2 therapy . . . . . . . . . . . . . . . . . . . 100

2 therapy . . . . . . . . . . . . . . . . . 101

2 and flow for O2 therapy. . . . . . . . 101

2 therapy . . . . . . . . . . . . . . . . . 102

2 therapy . . . . . . . . . . 100

Standby mode . . . . . . . . . . . . . . . . . . . . . . . . 102

Activating standby mode . . . . . . . . . . . . . . . . . 102

Continuing the therapy . . . . . . . . . . . . . . . . . . 103

Ending operation. . . . . . . . . . . . . . . . . . . . . . 103

Storing Babylog VN500. . . . . . . . . . . . . . . . . 104

Mains power supply / DC power supply . . . 105

Power supply unit PS500 . . . . . . . . . . . . . . . 107

Fault – Cause – Remedy on PS500 . . . . . . . . 109

Oxygen enrichment for suction

maneuver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Before suction. . . . . . . . . . . . . . . . . . . . . . . . . . 90

Automatic interruption of oxygen enrichment . . 91

After reconnection . . . . . . . . . . . . . . . . . . . . . . 91

Manual inspiration – Manual inspiration/hold92

Medication nebulization. . . . . . . . . . . . . . . . . 93

Safety information on medication nebulization . 93 Preparing the pneumatic medication nebulizer 93 Connecting the medication nebulizer to the

breathing circuit . . . . . . . . . . . . . . . . . . . . . . . . 94

Switching on medication nebulization. . . . . . . . 95

Aborting medication nebulization . . . . . . . . . . . 97

Required steps after medication nebulization. . 97

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 73

Page 74

Operation

123

Ventilation settings

BBB

Setting ventilation

Overview

This chapter describes how to set ventilation modes and basic settings as well as additional settings for ventilation parameters.

For a detailed description of the ventilation modes and ventilation parameters, see chapter "Description of the ventilation modes" on page 236 and "Additional settings for ventilation" on page 249.

Opening the Ventilation settings dialog window

The Ventilation settings dialog window can be opened as follows:

z Touch the Ventilation settings... button (A) in

the main menu bar.

z Touch the (B) button in the therapy bar.

z Touch the displayed ventilation mode (C) in the

header bar.

The page for the active ventilation mode (D) with the Basic settings (F) appears by default. The cor- responding therapy controls (E) are displayed.

The tab for Additional settings (G) can be used to supplement the active ventilation mode with additional settings.

083083

Selecting ventilation modes

Prerequisite: The Basic settings (A) page is opened.

Babylog VN500 opens the Ventilation settings dialog window.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

The Ventilation settings dialog window contains 5 tabs for selecting the ventilation modes. 4 tabs (B) have ventilation modes permanently assigned to them. The fifth tab (C) can be used to select another ventilation mode, which can be selected from the available ventilation modes.

078

The following 4 ventilation modes are preset at the factory: – PC-CMV –PC-AC –PC-SIMV – PC-PSV

Page 75

Operation

Ventilation settings

For information on changing the assignment of ventilation modes, see "Configuring start-up settings for the ventilation modes" on page 152.

Selecting an additional ventilation mode in the dialog window

1 Touch the Other modes (D) tab.

All the available ventilation modes (E) are displayed.

2 Touch the button for the corresponding ventila-

tion mode. The color of the (D) tab turns yellow.

3 Confirm with the rotary knob.

The additional ventilation mode is displayed in the fifth tab (C). The ventilation mode is active.

Setting ventilation parameters

Prerequisite: The Basic settings (A) page is opened.

1 Touch the corresponding therapy control, e.g.,

(B).

170077

2 Set the value by turning the rotary knob and

push to confirm.

The additional ventilation parameters derived from the ventilation parameter are calculated by Babylog VN500 and displayed in the setting assistance field (C).

Information is displayed in the message field (D), e.g., when the setting limit of a parameter has been reached.

131078

Changing the ventilation mode

1 Touch the corresponding tab, e.g., (F). The col-

2 Preset the ventilation parameters if necessary.

3 Confirm with the rotary knob. The color of the

The ventilation mode is active. The settings are applied to the patient.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 75

or of the tab turns yellow.

tab turns dark green.

Setting ventilation parameters in the therapy bar

The ventilation parameters of the active ventilation mode can also be set with the therapy controls in the therapy bar (E).

Additional information

"Exceeding the set limit of a ventilation parameter" on page 35.

"Direct setting of ventilation parameters (QuickSet)" on page 35.

Page 76

Operation

"Linked setting of ventilation parameters" on page 35.

Basic settings for ventilation

The basic settings of the ventilation parameters are listed in the following tables: – Pressure-controlled ventilation modes – Spontaneous breathing support

WARNING If flow measurement is deactivated for SPN-

CPAP with the use of a nasopharyngeal tube, use a separate monitoring device.

CAUTION

Only remove the water trap of the expiratory valve briefly during ventilation. Otherwise, ventilation will be impaired.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 77

Pressure-controlled ventilation modes

Operation

Ventilation parameters

FiO

2 XXXXXXX

VT X

PC-SIMV PC-AC PC-CMV PC-APRV PC-MMV PC-PSV PC-HFO

Ventilation mode

Ti X X X X

RR X X X X X

Slope or Insp. flow

Pmax X

Pinsp X

XXXXXX

PEEP X X X X X

ΔPsupp X X

Timax X

Thigh X

Tlow X

Phigh X

Plow X

Tlow max X

Exp. term. X

I:Ehf X

fhf X

Ampl hf X

MAPhf X

1) if VG is switched on

2) depending on configuration, Slope adjustment

3) if Pmax/Paw high autoset is activated and ATC or VG is switched on

4) if VG is switched off

5) in the Neo. patient category in the Tube application mode, or in the Ped. pat. patient category in the NIV application mode

6) If AutoRelease is switched off

7) if AutoRelease is switched on

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 77

Page 78

Operation

Spontaneous breathing support

Ventilation parameters

2 XXXX

FiO

SPN-CPAP/PS SPN-CPAP/VS SPN-CPAP

Ventilation mode

SPN-PPS

VT X

Timax X

Slope or Insp. flow

Pmax X

XXX

PEEP X X X X

ΔPsupp X

Vol. Assist X

Flow Assist X

TmanInsp X

PmanInsp X

1) only available in the Neo. patient category in the NIV application mode

2) in the NIV application mode or in the Neo. patient category

3) depending on configuration, Slope adjustment

4) if Pmax/Paw high autoset is activated

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 79

Additional settings for ventilation

Ventilation settings

Overview of possible supplementary settings

The ventilation modes can be combined with additional settings to optimize ventilation. The table shows the possible additional settings for the respective ventilation mode.

Operation

Ventilation

mode

Apnea

Ventilation

Trigger Sigh ATC Volume

Additional settings

Guaran-

tee

Auto

Release

HFO-

Sigh

Vol ume

Guarantee

(HFO)

PC-CMV X X X

PC-AC X XXX

PC-SIMV X X XXX

PC-PSV X X X X

PC-MMV X X X X

PC-APRV X X X

SPN-CPAP/PS X X X

SPN-CPAP/VS X X X

SPN-PPS X X X

PC-HFO XX

Setting the supplementary settings

Prerequisite: The page with the active ventilation

The page for setting the corresponding parameters is opened.

mode is open.

1 Touch the Additional settings (A) tab.

The additional settings of the active ventilation mode are displayed.

2 Touch the tab of the respective additional set-

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 79

ting (B).

3 Use the (C) buttons to activate or deactivate the

additional setting.

4 Touch the corresponding therapy control (D).

084

5 Set the value by turning the rotary knob and

push to confirm.

098

Page 80

Operation

Ventilation parameters of the additional settings

CAUTION

High trigger sensitivity may lead to auto-triggering of the ventilator.

Additional settings Ventilation parameters Dependencies, information

Apnea Ventilation On/Off

VTapn RRapn Pmax If Pmax/Paw high autoset is configured PEEP In PC-APRV Flow trigger In PC-APRV Slope In SPN-PPS

Configuration of the Automatic return from Apnea Ventilation function, see "Configuring general settings" on page 158. Description, see "Automatic re-

turn from apnea ventilation" on page 249. Trigger Flow trigger Sigh On/Off

ΔintPEEP Interval sigh Cycles sigh

ATC On/Off See chapter "Configuration" on page 141.

Tube type (ET/Trach.) only available in the Ped. pat. patient category Tube Ø Inside diameter of tube Compens. Degree of compensation:

Compens. = 100 % – airway pressure regulation to

the tracheal level

Pmax If Pmax/Paw high autoset is configured

Volume Guarantee On/Off See chapter "Configuration" on page 141

VT Pmax If Pmax/Paw high autoset is configured Pinsp If VG is switched off

AutoRelease On/Off

Exp. term. Tlow If AutoRelease is switched off Tlow max If AutoRelease is switched on

HFO-Sigh Psigh

RRsigh Tisigh Flowsigh If Insp. flow is configured, see page 158 Slopesigh If Slope is configured, see page 158

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 81

Additional settings Ventilation parameters Dependencies, information

Volume Guarantee (HFO)

On/Off VThf Ampl hf Set the amplitude before switching off the Volume

Guarantee (HFO)

Additional information

For a detailed description of the additional settings, see in chapter "Additional settings for ventilation" on page 249.

Operation

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 81

Page 82

Operation

NIV – Non-invasive ventilation

Overview

Babylog VN500 can be used for the ventilation of intubated patients (application mode Tube) and for non-invasive ventilation (application mode NIV).

This chapter describes the use of non-invasive ventilation in the NIV application mode.

The following ventilation modes can be selected in the NIV application mode:

Ventilation mode Patient category

Ped. pat. Neo.

PC-CMV X X

PC-AC X

PC-SIMV X

PC-PSV X

PC-MMV X

PC-APRV X

SPN-CPAP X

SPN-CPAP/PS X

SPN-CPAP/VS X

SPN-PPS X

When the PC-HFO ventilation mode is set, it is not possible to switch to the NIV application mode.

Safety information on using NIV

CAUTION

Application mode NIV must not be activated with intubated patients!

NOTE

Use suitable masks and prongs. Otherwise too high leakages may occur.

WARNI NG Avoid high airway pressures. Danger of aspi-

ration!

WARNI NG Alarm limits and ventilation settings must be

checked or set again in order to ensure complete monitoring of ventilation after changing from NIV application mode to Tube application mode.

Automatic tube compensation (ATC) which is activated in Tube application mode is ineffective in NIV application mode.

Selecting the NIV application mode

The application mode can only be selected in standby mode.

1 Touch the Start/ Standby... button in the main

menu bar.

Babylog VN500 opens the Start/Standby dialog window. The Start/Standby page appears by de- fault.

2 Touch the Standby button and confirm with the

rotary knob.

Babylog VN500 is in standby mode.

CAUTION

Use of masks increases the dead space. Note the mask manufacturer's instructions!

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 83

Operation

Start/Standby

Ventilation settings

3 Touch the Tube/NIV (A) tab.

4 Touch the NIV (B) button and confirm with the

rotary knob.

Babylog VN500 is in the NIV application mode. Babylog VN500 displays the symbol in the header bar

In the Neo. patient category, flow monitoring is deactivated.

Starting NIV ventilation

Prerequisite: The Start/Standby dialog window is opened.

1 Touch the Start/Standby (A) tab.

Babylog VN500 starts the therapy with the set ventilation parameters. The main screen for ventilation is displayed.

Setting ventilation parameters for NIV

z Set the ventilation parameters as described

under "Setting ventilation parameters" on page 75.

Therapy control Timax

113092

The therapy control Timax (A) limits the maximum duration of supported breaths (Pressure Support, Volume Support, PPS) because the inspiratory termination criterion may be ineffective with very high leakages.

z Set the value for Timax by turning the rotary

knob and push to confirm.

105339

Therapy controls TmanInsp and PmanInsp

Prerequisite: The Neo. patient category and the SPN-CPAP ventilation mode are set.

The Start (B) button remains preset for 15 seconds.

2 Confirm with the rotary knob.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 83

During manual inspiration, the duration of the mandatory breath is determined by the TmanInsp therapy control (B).

Page 84

Operation

During manual inspiration, the pressure of the mandatory breath is determined by the PmanInsp therapy control (C).

z Set and confirm the relevant values using the

rotary knob.

Monitoring during NIV

z Use additional monitoring, e.g., external SpO2,

if necessary.

A time-lag Tdisconnect between 0 and 60 seconds can be set for the lower alarm limit of the airway pressure.

Additional information

"Setting the alarm limits" on page 114.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 85

Display curves and measured values

123

Operation

Overview

This chapter describes how curves and measured values are displayed on the main screen as well as how to change the screen views during operation.

Changing the screen view

Babylog VN500 displays a preconfigured view on the main screen. 3 views can be grouped together specifically for the hospital concerned in the System setup dialog window.

Displaying other views

z Touch the Views... button in the main menu

bar.

The screen displays the second view .

z Touch the Views... button.

The screen displays the third view .

Changing the display of monitoring fields

The parameters can be displayed in parameter fields (A) and in the curve field (B).

The fields can be standard or double in size. The information that can be displayed depends on the size of the fields:

Parameter fields

Standard size Single parameter

Two parameters Short trend for measured

values Short trend for setting

values

Double size Single parameter

Parameter group Loop Short trend for measured

values Short trend for setting

values

Curve fields

Standard size Single curve

Trend for measured values Trend for setting values Tabular trend Multi-trend Alarm history

Double size Single curve

Single loop Double loop Trend for measured values Trend for setting values Tabular trend Multi-trend Alarm history Smart Pulmonary View

115

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 85

Page 86

Operation

Content

500.0

450.0

400.0

350.0

300.0

250.0

200.0

150.0

100.0

50.0

0.0

-5.0 0.0 5.0 10.0 15.0 20.0 25.0 30.0

Selecting the display of parameter fields

1 Touch the parameter field.

The selected parameter field is marked. Babylog VN500 opens the dialog for the contents of the parameter field.

Selecting the field size

2 Touch the 1x (C) button for standard size or

2x (D) for double size.

Selecting the display format

3 Touch the (E) button.

The selection list for the display of parameters is displayed according to the selected size of the parameter field.

4 Select the display format and confirm with the

rotary knob.

Selecting the parameter

5 Touch the (F) button.

The selection list for the displayable parameters is displayed.

6 Select the parameter and confirm with the rota-

ry knob.

Closing the dialog

7 Touch the X button. The dialog is closed.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Selecting the display of curve fields

1 Touch the curve field.

The selected curve field is marked. Babylog VN500 opens the dialog for the contents of the curve field.

2 Proceed as described under "Selecting the dis-

play of parameter fields".

Additional information

"Configuring the screen view" on page 144.

"Factory-set screen views" on page 275.

Evaluating loops

107

112

Displaying a reference loop

z Touch the Ref. (A) button.

A loop is recorded and displayed as a reference loop.

The date and the time of the loop appear beside the (A) button. The reference loop is drawn in black. The reference loop remains displayed until the Ref. (A) button is touched again.

Recording the current loop in order to freeze, display and save it afterwards

z Touch the Capture loop (B) button.

Page 87

Operation

The current loop is frozen. The loops are drawn in blue. After "freezing", a cursor (C) is displayed which can be moved with the rotary knob. The respective values are displayed (D).

Recording up to 10 loops of automatic or spontaneous breaths

1 Touch the Draw (E) button.

2 Set how many loops should be recorded with

the rotary knob and push to confirm.

The set number is displayed in the button.

The contrast with which loops are displayed decreases depending how far back the recording was made.

Additional information

A grid only appears if loops are displayed in the complete curve field.

Freeze waveforms

The Freeze waveforms function can be configured as a button in the main menu bar to enable direct access. See "Assigning functions to additional buttons" on page 146.

z Touch the Freeze waveforms button in the

main menu bar.

145

The current curves are immediately frozen. The cursor (A) displays the time of "freezing" and the value at the cursor position.

To display a measured value at a certain moment in time:

z Position the cursor on the time with the rotary

knob.

The measured value or the measured value pair are displayed above the curve.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 87

Page 88

Operation

Smart Pulmonary View

Smart Pulmonary View is a graphic display of the compliance and resistance as well as of the spontaneous and mandatory minute volume.

A double-size curve field must be configured in order to display Smart Pulmonary View. See "Configuring the screen view" on page 144.

A The movement of the diaphragm indicates syn-

chronized mandatory breaths or supported (triggered) breaths.

B The blue line around the trachea indicates the

resistance R. The higher the resistance, the thicker the line. The value is also displayed.

C The blue line around the lungs indicates the

compliance Cdyn. The higher the compliance, the thinner the line. The value is also displayed.

D Diagram displaying the relationship between

spontaneous breathing and mandatory ventilation. The following parameters are displayed in different colors: – VTspon and RRspon – VTmand and RRmand

Smart Pulmonary View must be calibrated for each new patient. If the measured values for R and Cdyn are outside the current display range, a red line appears and calibration is required. Babylog VN500 displays the following information Calibrate lung

display.

Calibrating Smart Pulmonary View:

z Touch the Calibrate (E) button.

The display range is adapted to the current measured values. The measured values from the last calibration are displayed as a broken line.

Additional information

For a detailed description, see "Smart Pulmonary View" on page 262.

316

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 89

Help

Ventilation settings

Operation

WARNING Risk of operating error.

The Help function is not a substitute for the Instructions for Use. The Instructions for Use must be observed to ensure safe operation.

The Help function can be configured as a button in the main menu bar to enable direct access. See "Assigning functions to additional buttons" on page 146.

Opening Help

z Touch the Help button in the main menu bar.

Opening Help in the dialog window

The Help function can also be opened in the following dialog windows:

– Ventilation settings

– Special procedures > Med. nebulization – Special procedures > Functions

171

z Touch the button (G) in the relevant dialog

window.

The appropriate section of the Help is displayed.

Closing Help

Touch the (G) or the (H) button in the relevant dialog window.

318

The following buttons are available in the Help dia- log window: – Home (A) to open the start page – (B) to scroll back – (C) to scroll forward – Content (D) to open the table of contents – Index (E) to open the index

z Touch the appropriate button.

Closing Help

z Touch the (F) button.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 89

Page 90

Operation

Special procedures

123

Oxygen enrichment for suction maneuver

Overview

To avoid any risk of hypoxia during endotracheal suction, Babylog VN500 offers a program for oxygen enrichment.

The O

2 concentration is increased to the current in-

spiratory O The factor can be configured, see page 158.

After the oxygen enrichment program is started, Babylog VN500 ventilates the patient for an initial oxygen enrichment phase of max. 180 seconds with an increased O time, Babylog VN500 waits for a disconnection.

When the device is disconnected for suction, Babylog VN500 interrupts ventilation. During the suction phase, the acoustic alarms are suppressed so that the suction maneuver is not disturbed.

After suction and automatically recognized reconnection, Babylog VN500 delivers an increased O

2 concentration for the final oxygen enrichment

phase of 120 seconds.

During suction and for 2 minutes afterwards, the lower alarm limit for the minute volume is switched off.

Initial and final oxygen enrichment are only possible with a fully functioning flow sensor and if flow monitoring is switched on!

2 concentration, multiplied by a factor.

2 concentration. During this

2 Touch the Functions (A) button if the page is

not already preset.

3 Touch the O

2 suction (B) button and confirm

with the rotary knob.

The oxygen enrichment program is started.

Babylog VN500 continues ventilating in the set ventilation mode with an increased O

2 concentration:

1 to 2-fold of the current FiO

If PEEP is not set to more than 4 mbar (4 cmH

2 concentration

2O),

PEEP will be applied automatically at 4 mbar

2O). This PEEP allows Babylog VN500 to

(4 cmH detect any subsequent disconnection. The other ventilation parameters remain unaffected.

Screen display:

081078

WARNING Select an appropriate suction catheter for suc-

tion. Otherwise this may result in a too high negative pressure.

Before suction

1 Touch the Special procedures... button in the

main menu bar.

Babylog VN500 opens the Special procedures dialog window.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

The (C) field in the header bar continuously displays the initial oxygen enrichment phase with the remaining time in seconds.

Initial oxygen enrichment lasts for a maximum of 180 seconds. During this time Babylog VN500 waits for a disconnection for suction. The oxygen

Page 91

enrichment program is terminated by Babylog VN500 if there is no disconnection after the 180 seconds have elapsed.

After disconnection for suction, Babylog VN500 delivers a minimal flow for the duration of disconnection in order to detect automatically the end of the disconnection phase. 120 seconds are available for suctioning. In the header bar, the disconnection phase with the remaining time available for suction is displayed continuously in seconds (C). If suction is ended and the system is reconnected within the displayed time, Babylog VN500 terminates the disconnection phase.

Automatic interruption of oxygen enrichment

If there is no reconnection when the available time (120 seconds) has elapsed, the oxygenation procedure is terminated. All alarms are immediately reactivated. Babylog VN500 immediately continues ventilating in the set ventilation mode.

Operation

After reconnection

After reconnection, Babylog VN500 continues ventilating in the set ventilation mode, except that for 120 seconds a correspondingly increased

2 concentration will continue to be delivered for fi-

O nal oxygen enrichment.

In the header bar, the remaining time available for the final oxygen enrichment phase is displayed continuously in seconds.

Aborting oxygen enrichment

z Touch the O

Additional information

The Suction maneuver function can be configured as a O

2 suction button in the main menu bar to en-

able direct access. See "Assigning functions to additional buttons" on page 146.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 91

2 suction button again.

Page 92

Operation

Special procedures

Manual inspiration – Manual inspiration/hold

The Manual inspiration/hold function can be activated in all ventilation modes and offers the following options:

– Between two automatic breaths, a breath can

be manually started and held. The pattern of the manually started breath corresponds to the ventilation pattern of the currently active automatic ventilation mode.

– Regardless of the start time, an automatic

breath can be prolonged.

1 Touch the Special procedures... button in the

main menu bar.

Babylog VN500 opens the Special procedures dialog window.

2 Touch the Functions (A) button if the page is

not already preset.

– After a maximum of 40 seconds in the Ped. pat.

patient category

– After a maximum of 5 seconds in the Neo. pa-

tient category

WARNI NG The Manual inspiration/hold function must not

be used during endotracheal suction. Otherwise negative pressure may jeopardize the patient.

Additional information

The Manual inspiration/hold function can be configured as a Man. insp./hold button in the main menu bar to enable direct access. See "Assigning functions to additional buttons" on page 146.

Triggering manual inspiration

z Briefly touch the Man. insp./hold button (B).

Manually extending inspiration

z Touch and hold the Man. insp./hold (B) button

for the desired inspiratory time.

Babylog VN500 triggers an extended breath or extends an already triggered automatic breath.

Babylog VN500 automatically ends inspiration:

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

081

Page 93

Medication nebulization

Operation

Safety information on medication nebulization

WARNING Inflammable agents must not be nebulized!

They may be ignited by the glowing flow sensor.

CAUTION

During medication nebulization, do not use a heat and moisture exchanger (HME) at the Y-piece. The medication will not be adequately administered to the patient.

CAUTION

Do not place a bacterial filter on the nebulizer outlet during nebulization! Bacterial filters may increase the flow resistance and impair ventilation.

CAUTION

Remove the medication nebulizer after use. Accidental medication nebulization may impair ventilation.

CAUTION

Surplus nebulized medication can affect the ambient air.

NOTE

Aerosols can impair the proper functioning of the expiratory valve. When using medication nebulization, shorten the reprocessing cycles for the expiratory valve.

Installing the pneumatic medication nebulizer

Medication nebulization is possible in the pressurecontrolled ventilation modes.

The medication nebulizer nebulizes continuously. But the aerosol generated during expiration does not reach the lungs.

The medication nebulizer is supplied with medical gas according to the set O deviations in the inspiratory O ±4 Vol% are possible. For respiratory rates above 12/min, refer to the graph on page 261.

In order to avoid false alarms and ensure monitoring:

z Use additional monitoring, e.g. SpO

sary.

2 concentration. Small

2 concentration up to

2, if neces-

Preparing the pneumatic medication nebulizer

Only use pneumatic medication nebulizer 8411030.

CAUTION

In order to ensure limitation of the nebulizer flow, only use pneumatic medication nebulizer

8411030.

z Prepare the medication nebulizer in accordance

with the corresponding Instructions for Use.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 93

Page 94

Operation

ABC

D A

Connecting the medication nebulizer to the breathing circuit

1 Insert the catheter connector (A) in the inlet port

of the medication nebulizer.

2 Insert the adapter (B) in the outlet port of the

medication nebulizer.

3 Fit the corrugated hose (C), length 0.13 m

(5.1 inches), to the adapter (B).

When using on the incubator

024025

321322

z Push the outlet port of the medication nebulizer

into the upper hose guide of the incubator.

When using without incubator

4 Remove the corrugated hose of the breathing

circuit (D) from the inspiratory port of the Y-piece and connect it to the catheter connector (A).

5 Connect the free end of the corrugated hose (E)

to the inspiratory port of the Y-piece.

Additional information

For the order numbers of catheter connector (A) and adapter (B), see the list of accessories.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

1 Press the inlet or outlet port of the medication

nebulizer into one side of the clip and the expiratory hose into the other.

2 Place the medication nebulizer in the vertical

position.

Page 95

Connecting the nebulizer hose

Special procedures

WARNING The nebulizer port (F) must be used for nebu-

lization only! Otherwise the proper functioning of the device may be disrupted and the patient endangered.

z Connect the nebulizer hose (G) to the nebulizer

port (F).

Operation

086323327

3 Touch the button for the desired nebulization

time (B).

Nebulization can be set for 5, 10, 15, 30 minutes.

Deactivating neonatal flow monitoring

064

z Fill the medication nebulizer in accordance with

the corresponding Instructions for Use.

CAUTION

Check the correct functioning of the medication nebulizer. Check whether aerosol is generated. A medication nebulizer fault is not detected by Babylog VN500.

z Touch the Off button (D) and confirm with the

rotary knob.

Removing the neonatal flow sensor from the breathing circuit

Switching on medication nebulization

1 Touch the Special procedures... button in the

main menu bar.

2 Touch the Med. nebulization (A) tab.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 95

Page 96

Operation

WARNING Fire hazard!

Before medication nebulization, remove the neonatal flow sensor from the Y-piece.

The wires of the neonatal flow sensor are hot. If the flow sensor is left in the breathing circuit during nebulization, medication aerosol deposits may build up and impair flow measurement. In the worst case, these deposits could catch fire! Disconnecting the neonatal flow sensor cable is not sufficient to prevent this.

The minute volume is not monitored without the neonatal flow sensor and apnea monitoring is limited. Use additional monitoring.

When using the Y-piece with integrated neonatal flow sensor (8410185):

305304

2 Remove the insert (H).

3 Insert the sealing plug (I) (8411024). The seal-

ing plug is a component of the medication nebulizer.

When using the ISO 15 neonatal flow sensor (8411130):

1 Disconnect the cable (F) from the neonatal flow

sensor (G).

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306

1 Remove the flow sensor (J) (housing and insert)

from the Y-piece.

2 Connect the tube catheter cone (K) to the

Y-piece.

z Replace or clean the neonatal flow sensor if

there is visible soiling. See "Dismantling neonatal flow sensor" on page 194.

After removing the neonatal flow sensor:

z Touch the Done (E) button.

Babylog VN500 starts nebulization. The symbol and the remaining nebulization time is displayed in the screen header bar.

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Operation

Babylog VN500 automatically switches off the medication nebulizer after the set nebulization time has elapsed.

A message indicating that nebulization has been ended appears in the screen header bar.

Aborting medication nebulization

z Touch the Cancel (C) button.

Required steps after medication nebulization

1 Remove any residual medication. Observe the

Instructions for Use of the medication nebulizer.

2 If a bacterial filter is used to protect the expira-

tory valve, exchange or remove the bacterial filter.

3 Re-insert the neonatal flow sensor in the

Y-piece.

4 Activate neonatal flow monitoring. See "Activat-

ing neonatal flow monitoring" on page 138.

5 When using a new neonatal flow sensor, cali-

brate the flow sensor. See "Neonatal flow sensor calibration" on page 129.

Fitting the Aeroneb Pro nebulizer

z Observe the Instructions for Use of the

Aeroneb Pro nebulizer.

z Observe the "Safety information for the use of

HMEs, bacterial filters and breathing circuits" on page 45.

z Observe the "Safety information on medication

nebulization" on page 93.

z Do not switch on the Med. nebulization func-

tion on Babylog VN500 as the Aeroneb Pro nebulizer does not require a nebulizer flow from Babylog VN500.

Before nebulization with Aeroneb Pro

1 Deactivate neonatal flow monitoring.

See "Deactivating neonatal flow monitoring" on page 137.

2 Remove the neonatal flow sensor from the

breathing circuit. See "Removing the neonatal flow sensor from the breathing circuit" on page 95.

WARNING Fire hazard!

Before medication nebulization, remove the neonatal flow sensor from the Y-piece.

The wires of the neonatal flow sensor are hot. If the flow sensor is left in the breathing circuit during nebulization, medication aerosol deposits may build up and impair flow measurement. In the worst case, these deposits could catch fire! Disconnecting the cable from the neonatal flow sensor is not sufficient to prevent this.

The minute volume is not monitored without the neonatal flow sensor and apnea monitoring is limited! Use additional monitoring.

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Operation

After nebulization with Aeroneb Pro

1 If a bacterial filter is used to protect the expira-

tory valve, exchange or remove the bacterial filter.

2 Re-insert the neonatal flow sensor in the

Y-piece.

3 Activate neonatal flow monitoring. See "Activat-

ing neonatal flow monitoring" on page 138.

4 When using a new neonatal flow sensor, cali-

brate the flow sensor. See "Neonatal flow sensor calibration" on page 129.

Additional information

z For the order number of the nebulizer

Aeroneb Pro, see the list of accessories.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n

Page 99

Gas supply unit GS500

Special procedures

B C

Operation

Babylog VN500 can be equipped with the GS500 gas supply unit in order to ensure the air supply to the device in the event of failure of the central gas supply and during the transportation of patients within the hospital.

When Babylog VN500 is supplied from the GS500 gas supply unit, the inspiratory O may deviate from the set FiO

2 concentration

Installing the bacterial filter

CAUTION

In order to protect the patient from contamination through the aspirated ambient air, an inspiratory bacterial filter must always be used.

z Fit the bacterial filter (A) onto the inspiratory

port.

gas supply, Babylog VN500 displays an alarm message. The gas supply unit starts the supply of air after 4 seconds at the latest.

Switching on the gas supply unit for the transportation of patients within the hospital:

1 Touch the Special procedures... button in the

main menu bar.

2 Touch the Transport (B) tab.

3 Touch the On (C) button.

4 Detach the connectors of the compressed gas

hoses from the wall outlets of the central gas supply.

If the connectors of the compressed gas hoses have not been detached within 5 minutes of the gas supply unit being switched on, Babylog VN500 switches off the gas supply unit.

342

Switching off the gas supply unit:

5 Touch the Off (D) button.

325

Using the gas supply unit

Prerequisite: Functionality of the gas supply unit is

z Deactivating functionality of the gas supply unit,

see "Device extensions" on page 164.

activated, see "Device extensions" on page 164.

Additional information

In the event of failure of the central gas supply, or if the connectors of the compressed gas hoses become detached from the wall outlets of the central

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Operation

O2 Therapy

Safety information on O2 therapy

During the O2 therapy, only the O2 concentration and the inspiratory pressure are monitored.

Oxygen masks, hoods, or nasal cannulas can be used for O

2 therapy.

CAUTION

Only use oxygen masks for the O2 therapy. Do not use masks for non-invasive ventilation (NIV). Use of unsuitable masks may jeopardize the patient.

CAUTION

Internal monitoring is deactivated. Airway pressure and ventilation parameters, e.g., flow, minute volume or apnea are not monitored. Use external

2 monitoring for patients who are dependent

SpO on an increased defined O2 concentration. Otherwise a worsening of the patient's condition cannot be detected.

Preparing O2 therapy

Attaching breathing hoses

WARNING Do not use antistatic or conductive breathing

hoses. The use of these materials increases the danger of electric shock to the patient and of fire in an oxygen-enriched environment.

Preparing the system with Fisher & Paykel MR 850 breathing gas humidifier

1 Hang the hinged arm (A) on the rail and tighten

the screws. Depending on the desired position of the device in relation to the bed, the hinged arm can be fitted to either side of the device.

2 Fit the breathing hoses (B) for inspiration. The

expiratory ports on the device and on the Y-piece remain open!

3 Switch on Babylog VN500. See page 58.

4 Switch Babylog VN500 to standby. See

page 102.

5 Switch on O

2 monitoring. See page 138.

The alarm limits for MV, Paw, RR, Tapn are not active. The alarm limits for O

2 monitoring are auto-

matically set by the device.

037

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Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n