Babylog 8000 Plus Instructions for Use sw 5.n Edition 8 Feb 2015

Typographical conventions 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 related illustration. A

Letters in illustrations denote elements referred to in the text.

Any text shown on the screen and any labeling on the device are printed in bold and italics, for example, FiO2, IPPV or Vent. Mode. Translations of these texts are printed in bold and italics and are placed in parentheses. These translations in parentheses are not displayed on the device.

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

Product name used In these instructions for use, the designation Babylog 8000 is used for "Babylog 8000 plus".

Screen reproductions The reproductions of screen content in the instructions for use can differ from the content actually shown on the screen.

The "greater than" symbol > indicates the navigation path in a dialog window, for example, Options > VIVE. In this example, Options represents the dialog window title and VIVE a screen in the dialog window.

Trademarks Trademark

Trademark owner

®

Babylog

BabyLink® DrägerService®

Dräger

MEDIBUS® Buraton®

2

Schülke & Mayr GmbH

Instructions for use Babylog 8000 plus SW 5.n

Safety information definitions WARNING

CAUTION

A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

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.

Definition of target groups For this product, users, service personnel, and experts are defined as target groups.

Service personnel

These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. The target groups must understand the language of the present document.

Service personnel are persons who are responsible for the maintenance of the product.

The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.

Users Users are persons who use the product in accordance with its intended use.

Instructions for use Babylog 8000 plus SW 5.n

Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.

Experts Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product.

3

Abbreviations and symbols Explanations can be found in the sections ''Abbreviations'' and ''Symbols'' in chapter ''Overview''.

4

Instructions for use Babylog 8000 plus SW 5.n

Contents

Contents For your safety and that of your patients...

7

Terminating operation ...

80

General safety information ... 8 Product-specific safety information... 12

Alarms ...

81

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

Display of alarms... 82 Suppressing the acoustic alarm signal... 83 Acknowledging alarm messages... 83 Alarm limits... 84

Overview... 17

Trends ...

Babylog 8000... Trolley... Range of functions... Abbreviations... Symbols... Product labels...

Displaying waveforms and measured values .. 87 Displaying trends... 90 Displaying the logbook ... 91

Application ... 15

18 22 23 24 26 27

Operating concept... 28 Control and display unit ... 29 Dialog windows... 33 Assembly and preparation ... 37 Safety information... Preparing the trolley ... Mounting an additional monitor ... Preparing the ventilator ... Connecting a gas analyzer ... Establishing the gas supply ... Establishing the power supply ... MEDIBUS protocol ... Establishing potential equalization ... Transport within the hospital...

38 38 40 42 48 49 50 51 52 53

Getting started ... 54 Safety information... Switching on the ventilator... Charging the battery for the power supply failure alarm... Checking readiness for operation...

55 55 57 58

Operation... 62 Setting ventilation ... Endotracheal suction ... Manual inspiration ... Medication nebulization ... Analog and digital interface ... Instructions for use Babylog 8000 plus SW 5.n

63 68 69 70 76

86

Monitoring...

92

Information on monitoring... O2 monitoring ... Flow monitoring ...

93 94 95

Configuration...

98

Displaying device information... 99 Setting date and time ... 99 Setting the volume of the alarm signal ... 100 Setting the screen contrast... 100 Selecting the language... 101 Configuring the data interfaces ... 101 Troubleshooting ... 105 Failure of the power supply ... 106 Alarm – Cause – Remedy ... 106 Cleaning, disinfection and sterilization... 110 Safety information ... 111 Dismantling the ventilator ... 111 Reprocessing methods... 114 Reprocessing list ... 117 After reprocessing ... 119 Maintenance... 120 Overview ... 121 Inspection ... 122 Preventive maintenance... 124 Repairs ... 125 Replacing the cooling air filter ... 126

5

Contents

Disposal ... 127 Disposal of the medical device... 128 Disposal of batteries... 128 Disposal of O2 sensors... 129 Technical data ... 130 Ambient conditions ... 131 Set values... 131 Performance characteristics ... 133 Displayed measured values ... 134 Displayed calculated measured values ... 137 Monitoring functions ... 138 Operating characteristics... 139 Device outputs... 141 Essential performance characteristics... 142 Alarm criteria ... 143 EMC Declaration ... 146 Connection to IT networks... 151 Principles of operation ... 152 Pneumatic function description ... 153 Description of ventilation modes ... 156 Additional settings for ventilation... 161 Measurements... 165

6

Instructions for use Babylog 8000 plus SW 5.n

For your safety and that of your patients

For your safety and that of your patients General safety information ...

8

Strictly follow these instructions for use... Maintenance ... Safety checks ... Accessories ... Not for use in areas of explosion hazard ... Connected devices ... Device combinations ... Patient safety... Patient monitoring... Information on electromagnetic compatibility .. Disposable product... Sterile accessories ... Installing accessories ... Storing the instructions for use ... Training...

8 8 8 8 9 9 9 10 10 10 11 11 11 11 11

Product-specific safety information ... 12 Ensuring ventilation using an independent manual ventilator ... 14

Instructions for use Babylog 8000 plus SW 5.n

7

For your safety and that of your patients

General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this device.

Strictly follow these instructions for use WARNING Risk of incorrect operation and incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under ''Intended use'' (see page 16) and in conjunction with appropriate patient monitoring (see page 10). Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Maintenance WARNING Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. Dräger recommends DrägerService for a service contract and for repairs. Dräger also recommends using original Dräger parts for maintenance. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter ''Maintenance''.

Safety checks The medical device must be subject to regular safety checks. See chapter ''Maintenance''.

Accessories WARNING Risk due to incompatible accessories Dräger has only tested the compatibility of accessories that appear in the current list of accessories or in separate declarations by Dräger. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends using the medical device only with accessories from the current list of accessories.

8

Instructions for use Babylog 8000 plus SW 5.n

For your safety and that of your patients

Not for use in areas of explosion hazard WARNING Risk of fire The device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur.

Connected devices WARNING Risk of electric shock and of device malfunction Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer. Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations.

Device combinations This device can be operated in combination with other Dräger devices or with devices from other manufacturers. Observe the accompanying documents of the individual devices. If a device combination is not approved by Dräger, the safety and the functional state of the individual devices can be compromised. The operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices. Device combinations approved by Dräger meet the requirements of the following standards: –

IEC 60601-1, 3rd edition (general requirements for safety, device combinations, softwarecontrolled functions) – IEC 60601-1-2 (electromagnetic compatibility) – IEC 60601-1-8 (alarm systems)

Or: –

IEC 60601-1, 2nd edition (general requirements for safety) – IEC 60601-1-1 (device combinations) – IEC 60601-1-2 (electromagnetic compatibility) – –

Instructions for use Babylog 8000 plus SW 5.n

IEC 60601-1-4 (software-controlled functions) IEC 60601-1-8 (alarm systems)

9

For your safety and that of your patients

Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. The instructions for use do not contain any information on the following points: –

Risks that are obvious to users

–

Consequences of obvious improper use of the medical device

–

Potentially negative effects on patients with different underlying diseases

Medical device modification or misuse can be dangerous.

Patient monitoring The user of the medical device is responsible for choosing suitable monitoring that provides appropriate information about medical device performance and the patient's condition. Patient safety may be achieved by 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 selecting the best level of patient monitoring lies solely with the user of the medical device.

Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided (see ''EMC Declaration''). Portable and mobile radio frequency communication equipment can affect medical electrical equipment. WARNING Risk of electric shock Do not connect connectors with an ESD warning symbol and do not touch their pins without implementing ESD protective measures. Such protective measures can include antistatic clothing and shoes, touching a potential equilization pin before and during connection of the pins, or using electrically insulating and antistatic gloves. All users concerned must be instructed in these ESD protective measures. WARNING Risk of device failure Electromagnetic fields can compromise proper operation of the device. Electromagnetic fields are generated by, e.g.,: – Mobile phones – Radio frequency electrosurgical equipment – Defibrillators – Shortwave therapy equipment Maintain sufficient safety distances, see EMC declaration in chapter ''Technical data''.

10

Instructions for use Babylog 8000 plus SW 5.n

For your safety and that of your patients

Disposable product

Storing the instructions for use

WARNING

CAUTION

Risk of patient injury due to failure of accessories

Risk of incorrect use

Disposable products have been developed, tested, and manufactured for disposable use only. Reuse, reprocessing or sterilization can lead to a failure of the accessories and cause injuries to the patient. Do not reuse, reprocess, or sterilize disposable products.

Instructions for use must be kept accessible to the user.

Training User training is offered by the responsible Dräger organization, see www.draeger.com.

Sterile accessories CAUTION Risk of medical device failure and of patient injury Do not use sterile-packaged accessories if the packaging has been opened, is damaged, or if there are other signs of non-sterility.

Installing accessories CAUTION Risk of device failure Install the accessory on the basic device in accordance with the instructions of the basic device. Check for secure connection to the basic device. Strictly observe the instructions for use and assembly instructions.

Instructions for use Babylog 8000 plus SW 5.n

11

For your safety and that of your patients

Product-specific safety information WARNING

WARNING

Risk of incorrect use

Risk of patient injury with PEEP <2.5 mbar (2.5 cmH2O)

This medical device is intended to be used only by the target group "users". WARNING Risk of suffocation following device failure If the gas inlet for the emergency breathing valve is obstructed, the patient will not be able to breathe spontaneously in the case of a device failure. Do not obstruct the gas inlet for the emergency breathing valve. WARNING Risk of malfunction

If the PEEP is set to <2.5 mbar (2.5 cmH2O) and the following settings are also made, the integrated pressure monitoring cannot detect an alarm situation during disconnection or extubation and their immediate consequences: – Pinsp <10 mbar (10 cmH2O) – Ventilation mode with volume guarantee – Change from a ventilation mode with VG into the ventilation mode IPPV, without switching off VG From a PEEP of 2.5 mbar (2.5 cmH2O) the risk of an undetected alarm situation increases with decreasing PEEP values.

This medical device must not be altered without permission from Dräger.

Use external ventilation monitoring as well as the following types of monitoring with narrow alarm limits: – SpO2 monitoring – Bradycardia monitoring – TcO2/TcCO2 monitoring

WARNING

WARNING

Risk of patient injury

Risk of eye injury

During magnetic resonance imaging the correct functioning of the medical device can be impaired.

With neonates, the administration of increased O2 concentrations can lead to retinopathy of prematurity.

Do not use the medical device during magnetic resonance imaging.

Use additional monitoring, e.g., external SpO2 monitoring.

WARNING

WARNING

Risk of patient injury

Risk of incorrect NO dosing

In hyperbaric chambers the correct functioning of the medical device can be impaired.

If a device for nitric oxide (NO) delivery without internal NO monitoring is used, patient monitoring is not guaranteed.

Do not use the medical device in hyperbaric chambers.

Monitor the NO concentration separately.

Unallowed modifications to the medical device lead to malfunctions.

12

Instructions for use Babylog 8000 plus SW 5.n

For your safety and that of your patients

WARNING

WARNING

Risk of fire

Risk of fire

The flow sensor can ignite medications or other substances based on highly flammable substances. – Do not nebulize medications or other substances that are easily flammable or spray them into the device. – Do not use substances containing alcohol. – Do not allow flammable or explosive substances to enter the breathing system or the breathing circuit.

The medical device may catch fire as a result of oxygen enrichment in the ambient air. Medical device malfunctions can increase the O2 concentration in the ambient air.

WARNING Risk due to failure of flow measurement Deposits that were not removed during reprocessing can damage the measuring wires in the flow sensor or cause a fire. – Before inserting the flow sensor check for visible damage, soiling, and particles. Repeat this check regularly. – Replace flow sensors when damaged, soiled, or not particle-free. WARNING Risk of fire The use of unapproved O2 pressure reducers can lead to excess pressure, which can cause a fire. – When supplying the ventilator with oxygen from a compressed gas cylinder, only use pressure reducers compliant with ISO 10524. – Slowly open the pressure reducer manually. Do not use tools.

Instructions for use Babylog 8000 plus SW 5.n

The medical device is only suitable for use in rooms with sufficient ventilation. WARNING Risk of fire Do no use the medical device together with flammable gases or flammable solutions that may become mixed with air, oxygen or nitrous oxide, or other ignition sources, as the medical device may catch fire. Do not allow the medical device to come into contact with sources of ignition. WARNING Risk of electric shock There is a risk of electric shock if the connectors of the interfaces and the patient are touched simultaneously. Do not simultaneously touch the connectors of the interfaces and the patient. WARNING Risk of patient injury Penetrating liquid may cause malfunction of the device, which may endanger the patient. – Do not place any containers with liquid on or above the device. – Make sure that no liquid penetrates into the device when disinfecting surfaces.

13

For your safety and that of your patients

CAUTION

CAUTION

Risk of patient injury

Risk of personal injury

Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

If the glass on the LC screen is damaged, a chemical liquid may escape. – Avoid contact with the body. – Immediately clean affected skin areas with soap.

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

Ensuring ventilation using an independent manual ventilator

Monitor the patient's condition.

WARNING

CAUTION Reduced O2 concentration When nitric oxide (NO) is added, the set inspiratory O2 concentration may be reduced. Monitor the O2 concentration. CAUTION Risk of medical device overheating

Risk of patient injury If a fault is detected in the medical device, its life-support functions may no longer be assured. Ventilation of the patient using an independent ventilation device must be started without delay, if necessary with PEEP and/or an increased inspiratory O2 concentration (e.g., with a manual resuscitator).

The medical device may overheat due to sources of heat such as direct sunlight, heat radiators, or spotlights. – Keep the medical device away from sources of heat. – Only operate the medical device in rooms with sufficient ventilation. – Do not cover the medical device or slide the rear of the device against a wall. CAUTION Risk of medical device overheating If the ventilation slots on the medical device are covered or sealed, the medical device may overheat. – Air must be able to enter freely. – An alarm is triggered if the medical device overheats during operation.

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Instructions for use Babylog 8000 plus SW 5.n

Application

Application Intended use ... 16 Environment of use ... 16

Instructions for use Babylog 8000 plus SW 5.n

15

Application

Intended use Babylog 8000 plus 5.n is a long-term ventilator for premature babies, newborns, and children with a body weight of up to approx. 20 kg (44 lbs). The device must only be operated by doctors or, on a doctor's order, by clinical personnel. Each user must be trained and familiar with the instructions for use.

Environment of use Babylog 8000 is intended for use in intensive care units. Do not use Babylog 8000 in the following environments: –

In hyperbaric chambers

–

For magnetic resonance imaging (MRI, NMR, NMI)

–

In conjunction with flammable gases or flammable solutions that can mix with air, oxygen, or nitrous oxide

–

In areas of explosion hazard

–

In areas with combustible or explosive substances

–

In rooms without sufficient ventilation

16

Instructions for use Babylog 8000 plus SW 5.n

Overview

Overview Babylog 8000 ... 18 Ventilator on trolley... Control and display unit ... Patient connection panel ... Rear...

18 19 20 21

Trolley... 22 Range of functions ... 23 Ventilation functions ... Monitoring functions ... Power supply ... Gas supply... Data transfer (optional)... Medication nebulization ... Non-invasive ventilation...

23 23 23 23 23 23 23

Abbreviations... 24 Symbols... 26 Product labels... 27

Instructions for use Babylog 8000 plus SW 5.n

17

Overview

Babylog 8000

Ventilator on trolley

A B C E

21988

D

A Control and display unit, display panel B Control and display unit, control panel C Control panel cover D Trolley E Patient connection panel

18

Instructions for use Babylog 8000 plus SW 5.n

Overview

Control and display unit

A

B

C

D

Q

E F

P

G O H N

I

L

A LED Trigger B Screen

K J

J

21096

M

PEEP/CPAP setting knob with mechanical release for PEEP <2.5 mbar (2.5 cmH2O)

C Bar display for airway pressure Paw

K TE setting knob

D Visual alarm display

L Pinsp setting knob M TI setting knob

–

Flashes red in the event of an alarm of medium or high priority

N Insp. Flow

–

Flashes yellow if set value TI is incorrect

O O2-Vol.% setting knob

setting knob

E Key to suppress alarm tone for 2 minutes

P Cal. Config. key

F OK key

Q man. Insp. key

G Key to select dialog windows H Vent. Mode key for ventilation modes I

Vent. Option key for additional settings

Instructions for use Babylog 8000 plus SW 5.n

19

Overview

Patient connection panel

B

C

D 21100

A A "Exhaust" muffler

B Rocker lever for expiratory valve C Expiratory port "GAS RETURN" D Inspiratory port "GAS OUTPUT"

20

Instructions for use Babylog 8000 plus SW 5.n