Dräger Babylog 8000 plus Instructions For Use Manual

Intensive Care Ventilator

for Neonates

Software 5.n

Instructions for Use

Babylog 8000 plus

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.

Working with these Instructions for Use

2

Working with these Instructions for Use

Header line...

the title of the main chapter.

The title of the specific sub-section is printed underneath the

main header – to help you find your way quickly from subject

to subject.

Page body...

the Instructions for Use

in combined text/illustrations. The information is expressed in

the form of practical actions, giving the user direct hands-on

experience in learning how to use the machine.

Left-hand column...

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.

Bullet points indicate separate actions. Where several actions

are described, numbers are used both to refer to the relevant

details in the illustrations and to specify the sequence of

actions.

Right-hand column...

the illustrations

provide the visual reference for the text and make it easier to

locate the various parts of the equipment. Elements mentioned

in the text are highlighted. Unnecessary details are avoided.

Screen displays prompt the user to proceed and confirm

correct actions.

Definitions

WARNING

A WARNING statement provides important information

about a potentially hazardous situation which, if not

avoided, could result in death or serious injury.

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 equipment or other property.

NOTE

A NOTE provides additional information intended to avoid

inconvenience during operation.

Preparation

24

Calibration

For oxygen measurement:

– This is done automatically every 24 hours during operation.

– It must be done manually each time the sensor is replaced.

– It may be done manually at any time.

For flow measurement:

– This must be done each time the ventilator is switched on

and

– each time the sensor is replaced.

For pressure measurement:

– This is done automatically each time the ventilator is

switched on.

Calibrating the O

2 sensor manually

This is required only when the sensor is replaced, but may be

done at any time.

1 Press the key »Cal. Config.«.

2 Press the key »O

2-Cal«.

3 After about 5 minutes, the display »O

2-Cal« disappears

from the status window, indicating that calibration is

complete.

222

1

027

2

028

3

Contents

3

Contents

For Your Safety and that of Your Patients 5

Intended Use 8

Operating Principle 9

Preparation 15

Operation 31

Fault – Cause – Remedy 77

Care 81

Maintenance intervals 93

What’s What 95

Technical Data 101

Description 113

Parts List/Order List 131

Index 136

4

5

For Your Safety and that of Your Patients

For Your Safety and that of Your

Patients

Strictly follow these Instructions for Use

Maintenance

Accessories

Not for use in areas of explosion hazard

Safe connection with other electrical equipment

WARNING

Any use of the medical device requires full

understanding 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 8 and in conjunction with appropriate patient

monitoring. 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 product that is inconsistent with its intended use.

WARNING

The device must be inspected and serviced regularly by

trained service personnel. Repair of the device may also

only be carried out by trained service personnel.

Dräger recommends that a service contract be obtained

with DrägerService and that all repairs also be carried

out by DrägerService. Dräger recommends that only

authentic Dräger repair parts be used for maintenance.

Otherwise, the correct functioning of the device may be

compromised.

Observe chapter "Maintenance Intervals".

WARNING

Only the accessories indicated on the Order List have

been tested and approved to be used with the device.

Accordingly, it is strongly recommended that only these

accessories be used in conjunction with the specific

device. Otherwise, the correct functioning of the device

may be compromised.

WARNING

The device is neither approved nor certified for use in

areas of explosion hazard.

WARNING

Risk of patient injury

Electrical connections to equipment not listed in these

Instructions for Use should only be made following

consultation with the respective manufacturers.

Networking

Device combinations approved by Dräger (see Instructions for

Use of the individual devices or units) meet the requirements of

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 to other Dräger

devices or third-party devices and the resulting combination is

not approved by Dräger, the owner must ensure that the

resulting system meets the requirements of the above-

mentioned standards.

Strictly observe Assembly Instructions and Instructions for Use

for each networked device.

Patient safety

The design of the medical device, the accompanying docu-

mentation, and the labelling on the medical device are based

on the assumption that the purchase and the 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 therefore largely limited to the

specifics of the Dräger device.

These Instructions for Use exclude references to various

hazards which are obvious to medical professionals, to the

consequences of medical device misuse, and to potentially

adverse effects in patients with different underlying diseases.

Medical device modification or misuse can be dangerous.

6

For Your Safety and that of Your Patients

Patient monitoring

The operators of the medical device must recognise their

responsibility for choosing appropriate safety monitoring that

supplies adequate information on device performance and

patient condition.

Patient safety may be achieved through a wide variety of

means ranging from electronic surveillance of device perform-

ance and patient condition to simple, direct observation of clin-

ical signs.

The responsibility for selecting the best level of patient moni-

toring lies solely with the medical device operator.

CAUTION

Risk of patient injury

Do not make therapeutic decisions based solely on individual

measured values and monitoring parameters.

General safety information

The following WARNINGS and CAUTIONS apply to general

operation of the medical device.

WARNINGS and CAUTIONS specific to subsystems or partic-

ular 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 medical device.

WARNING

The medical device must only be operated by trained

medical professionals.

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. Keep igni-

tion sources away from medical devices.

WARNING

If PEEP is set to <2.5 mbar, additional respiratory

monitoring and external saturation monitoring (SpO

2 with

narrow alarm limits) or Bradycardia monitoring (heart

rate) or TcO

2 / TcCO2 monitoring (also using narrow alarm

limits) must be used.

With the following equipment settings and a PEEP

of <2.5 mbar, a patient disconnection or extubation or

their immediate consequences can only be detected

securely and flagged as an alarm situation by these

monitoring combinations, and not by the integrated

pressure monitoring of the device:

– Ventilation mode with VG and PEEP of <2.5 mbar

simultaneously.

– Pinsp <10 mbar and PEEP of <2.5 mbar simultane-

ously.

– Switching from a ventilation mode using VG to IPPV

without turning VG off and with a PEEP of <2.5 mbar.

Therefore: Turn VG off when switching to IPPV.

Due to equipment and hose system tolerances, in

these cases no exact PEEP limits can be indicated for

omission of the alarm. This risk increases with a PEEP

of 2.5 mbar and lower.

CAUTION

Extractive monitors can generate a vacuum in the airway

if the inspiration tube becomes blocked.

Connect the sampling line of the extractive monitor only via

the adapter with safety valve 84 12 448.

CAUTION

If the integrated apnoea monitor is switched off, use

a separate apnoea monitoring device, otherwise apnoea

monitoring will not take place.

7

For Your Safety and that of Your Patients

Note on EMC/ESD risk for the device function

General information on electromagnetic compatibility EMC/

ESD declaration according to international EMC standard

IEC 60601-1-2:

Medical electrical equipment requires special precautions

regarding electromagnetic compatibility (EMC) and needs to

be installed and put into service according to the EMC informa-

tion provided in the technical documentation. See Technical

Data, "EMC Declaration" on page 109.

Portable and mobile RF communications equipment can affect

medical electrical equipment.

Ensuring ventilation using an independent manual

ventilator

WARNING

Pins of connectors identified with the ESD

warning symbol shall not be touched and

shall not be connected unless ESD precautio-

nary procedures are used. Such protective measures

may include antistatic clothing and shoes, touching

a ground stud before and during connection of the pins,

or using electrically insulating and antistatic gloves.

All personnel involved in the above shall receive instruc-

tion in these ESD protective measures

.

WARNING

In the case of an obvious defect in the device, the life-

support function may be endangered. The patient must

be ventilated immediately using an independent venti-

lator. If necessary, PEEP and/or an increased inspiratory

O

2 concentration should be applied (e. g. with the

manual ventilation bag MR-100).

8

Intended Use

Babylog 8000 plus 5.n

Long-term ventilator for premature and newborn babies and for

infants weighing up to 20 kg.

It is intended for use in an intensive care area.

The unit should only be operated by qualified personnel.

All users must be suitably trained and must be familiar with the

Instructions for Use.

Use of the ventilation modes

– IPPV/IMV (Intermittent Positive Pressure Ventilation and

Intermittent Mandatory Ventilation)

Controlled ventilation according to a predetermined pattern

and frequency, regardless of the patient's spontaneous

breathing.

– SIPPV (Synchronized Intermittent Positive Pressure

Ventilation)

Controlled ventilation with a predetermined pattern or

predetermined tidal volume, synchronised with each

spontaneous breath by the patient.

– SIMV (Synchronized Intermittent Mandatory Ventilation)

Controlled ventilation with a predetermined pattern or

predetermined tidal volume and frequency, synchronised

with the patient's spontaneous breathing. The patient

breathes spontaneously between the synchronised ventila-

tion strokes.

– PSV (Pressure Support Ventilation) – optional

Synchronised ventilation with a predetermined inspiration

pressure or predetermined tidal volume. The patient

determines the duration of the inspiration and the ventilation

frequency.

– CPAP (Continuous Positive Airway Pressure)

Spontaneous breathing with positive airway pressure.

The above ventilation modes can be combined with the

following special functions:

– VG (Volume Guarantee) – optional

Volume-controlled ventilation. The unit automatically regu-

lates the inspiration pressure in order to achieve a predeter-

mined tidal volume.

This can be combined with SIPPV, SIMV and PSV.

– HFV (High

Frequency Ventilation) – optional

High-frequency ventilation for patients weighing up to 2 kg.

This can be combined with IPPV/IMV or CPAP.

– VIVE (Variable Inspiratory Variable Expiratory Flow)

Separately adjustable continuous flow during the expiration

phase of mandatory ventilation. This cannot be combined

with HFV.

The ventilator monitors:

– inspiratory oxygen concentration,

– airway pressure,

– flow,

–tidal volume and

– breathing rate (for panting breathing).

The Babylog 8000 plus can be equipped with an interface for

the transfer of measured data and settings to units such as

patient monitors or computers.

If necessary, the ventilator can also be combined with a medical

nebulizer.

MEDIBUS

Software protocol for the transfer of data between

Babylog 800 plus and an external medical or non-

medical device (e.g. patient monitors or computers

for data management systems) via an RS 232 port, see

"MEDIBUS for Dräger Intensive Care Devices" (9029205).

All transferred data are for information only and should not

be used as a basis for diagnostic or therapeutic decisions.

To protect the patient and the user against electrical hazards,

it is essential that all systems consisting of medical devices

as well as other electrical devices which are not restricted

to computers, printers etc., are only assembled by trained

personnel.

The system must meet the requirements of the

IEC/EN 60601-1-1 and IEC/EN 60601-1-2 standards.

Operating Principle

9

Operating Principle

Layout of the front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Display panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Layout of the screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Ventilation menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Monitoring menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Calibration/Configuration menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Operating Principle

10

Layout of the front panel

Operating Principle

Layout of the front panel

The front panel consists of the control panel and the display

panel with a screen.

Control panel

This carries the keys for ventilation modes and rotary knobs for

adjusting important ventilation parameters.

The rotary knobs which can be adjusted for current selected

ventilation modes are indicated by green LEDs. These LEDs

blink if any adjustments are limited internally or still need to be

acknowledged.

1 Rotary knobs for ventilation parameters.

2 Pressing the key »Vent. Mode« selects the menu for

ventilation modes.

3 Pressing the key »Vent. Option« selects the menu for

additional functions for ventilation modes.

201

111

1

11

2

3

11

Operating Principle

Layout of the screen

Display panel

This carries the screen, the pressure display and various keys

with fixed or variable functions.

1 Pressing the key » « suppresses audible alarms for

2 minutes.

2 Pressing the key »OK« acknowledges messages or

settings.

3 Pressing the key »man. Insp.« initiates manual inspiration

breaths.

4 Pressing the key »Cal. Config.« selects the

calibration menu.

5 The six keys below the screen are used in various menus

for selecting monitoring functions and ventilation modes.

6 The bargraph display above the screen shows airway

pressure.

Layout of the screen

1 The graphics window displays either the pressure curve

or the flow curve, as desired.

2 The measured-value window displays measured values

such as MV, FiO

2, Peak, Mean, PEEP in numerical format.

3 The status window displays the currently selected

ventilation mode and other status information.

4 The menu line gives the current function of the menu key

in text and symbols.

In some cases, the graphics window and the measured-value

window are combined to form a single window.

Messages are displayed in a superimposed window on the

current display:

Display (example):

Apnoea

202

6

1

2

3

4

5

003

1

2

3

4

004

Operating Principle

12

Menu structure

Ventilation menu

005

006007008009010

13

Operating Principle

Menu structure

Monitoring menu

011

012013014015016017

Operating Principle

14

Menu structure

Calibration/Configuration menu

018

019020021022023

Preparation

15

Preparation

Mounting Babylog 8000 plus on a trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Inserting the expiration valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Inserting the O

2 sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Connecting the gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Connecting the electrical supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Breathing gas humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Connecting the ventilation hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Installing the bacterial filter (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

For high-frequency ventilation (HFV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Installing the Y-piece and the flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Before using for the first time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Calibrating the O

2 sensor manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Calibrating the flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Replacing the insert of the flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Checking the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Preparation

16

Mounting Babylog 8000 plus on a trolley

Preparation

Mounting Babylog 8000 plus on a trolley

z Turn the trolley so that the two lockable castors are on

the right.

Safety information for using the trolley 0.5 B (84 09 280)

Mount the Babylog 8000 plus on the trolley in this position:

1 Tilt the Babylog 8000 plus forwards.

2 Engage the front latches in the slots of the mounting plate.

3 Lower the Babylog 8000 plus, insert the rear latches in the

slots of the mounting plate and secure the unit with the

knurled screws on the rear.

z Place the shelf on the Babylog 8000 plus, engaging the two

tabs in the slots at the rear of the unit.

CAUTION

The operator must be physically capable of safely moving the

trolley with ventilator.

Remove monitors and accessories (e.g. hinged arm, brea-

thing gas humidifier) before transportation. Failure to observe

this may result in the device toppling over.

Hold the trolley at the handle and move no faster than at

a walking pace. There is an increased danger of the trolley

toppling over at thresholds, uneven surfaces, corners and

ramps. Reduce the speed of transport further. Do not move

the trolley over hoses, lines and other obstacles. Danger of

damage to device or personal injury.

CAUTION

Do not place containers with liquids above or on the device!

Any liquids entering the ventilator may impair its operation!

203204

1

2

3

205

17

Preparation

Inserting the expiration valve

Use a sterile expiration valve!

1 Lift the lever upwards to unlock the expiration valve.

z Slide the expiration valve as far as possible onto the

guide rods.

2 Push the lever down again to lock the expiration valve.

3 Fit the silencer on the exhaust nozzle of the expiration valve.

Inserting the O2 sensor

This must be done:

– before the ventilator is used for the first time,

– when the sensor is exhausted and can no longer be

calibrated.

z Unscrew the two slotted screws in the cover on the right-

hand side and pull the cover out.

z Pull out the exhausted O2 sensor.

z Insert the new O2 sensor with the circular printed wiring

towards the cover.

z Press the cover into place and tighten the two screws.

z Allow the O2 sensor to run for 15 minutes and then

calibrate the O

2 measurement manually (page 24).

z Dispose of the old O2 sensor as special waste (page 94).

206

1

2

3

207

Babylog 8000 plus

Preparation

18

Connecting the gas supply

z Screw the medical air and oxygen hoses into the rear of the

Babylog 8000 plus and insert the plug connectors into the

wall outlets.*

If the medical air is supplied from a compressor:

z Screw the high-pressure water trap 84 12 628 onto the air

connector and screw the medical air hose into the high-

pressure water trap.

Connecting the electrical supply

The mains voltage must lie within the supply voltage range

specified on the rating plate on the rear of the ventilator.

z Insert the mains plug of the Babylog 8000 plus into the

outlet socket.

Breathing gas humidifier

– The humidifier must comply with the standard EN ISO 8185.

– The hose resistance must be less than 20 mbar/L/s

inspiratory resistance ≤12 mbar/L/s,

expiratory resistance ≤8 mbar/L/s.

– The combination of the humidifier with the Babylog 8000 plus

should not impair the safety and function of either unit.

z Prepare the humidifier for use as described in the related

Instructions for Use.

* EN 794-1, Ventilation equipment:

"If the unit is used with O

2, adequate ventilation must be provided in

order to avoid an increased risk of fire due to an O

2 concentration of

more than 24 % by volume".

NOTE

The gases must be dry and connectors free of oil and dust,

otherwise the device may malfunction!

Either: 100 V

~

to 127 V

~

or: 220 V

~

to 240 V

~

208

Air O2

209

Air O2

19

Preparation

Assembly

Connecting the ventilation hoses

z Fit the ventilation hoses on the nozzles. Observing the

permissible hose lengths (in metres).

When not using in combination with an incubator

Use the hinged arm with claw:

z Swing both nozzles downwards or towards the patient.

z Fit the ventilation hoses on the nozzles. Observing the

permissible hose lengths (in metres).

z Install the water trap in a vertical position.

WARNING

Only use antistatic or non-conductive hoses, to avoid

risk to the patient.

Only use hose systems that are described here or if they

have an internal diameter of at least 10 mm, since the

measurement of the airway pressure may otherwise be

impaired!

NOTE

Always hold the hoses by their sleeves when fitting and

removing them since they can otherwise be damaged.

210211

0.5m

0.4m

1.1m

1m

Preparation

20

Assembly

When using with Dräger Incubator 8000

or Dräger Incubator Caleo

z Install the water trap in a vertical position.

z Mount the holder for the ventilation hoses in the incubator.

z Press the rubber sleeves of the ventilation hoses into the

clamp of the holder.

Installing the bacterial filter (optional)

A bacterial filter can be fitted on the inspiration side in order to

protect against contamination.

z Use modification kit 84 10 230.

1 Fit the 0.25 metre ventilation hose to the inspiration nozzle.

2 Insert the Ø15 / Ø22 diameter adapter in the

ventilation hose.

3 Plug the bacterial filter into the adapter.

4 Plug a size II catheter connector into the bacterial filter.

z Connect the ventilation hoses.

z Observe the Instructions for Use for the bacterial filter.

For high-frequency ventilation (HFV)

Use the "HF Fisher & Paykel" (84 11 153) hose set with reusable

chamber Fisher & Paykel MR 430 (84 11 047) or with single-use

chamber Fisher & Paykel MR 290 (84 18 282).

The low compliance of this hose system reduces the damping

of high frequency oscillations, thus ensuring adequate gas

volumes.

z Fit the ventilation hoses on the nozzles, observing the

permissible hose lengths (in meters).

z Install the water trap in a vertical position.

212213

1

2

4

3

214

0.4m

0.75m

0.65m

Ø12mm

0.4m

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Dräger Babylog 8000 plus Instructions For Use Manual

Dräger Babylog 8000 plus Instructions For Use Manual

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