Dräger Infinity Acute Care System Workstation Critical... Bedienungsanleitung

Supplement to

instructions for use

SW 2.n

WARNING

To properly use this medical device,

read and comply with the instructions

for use and this supplement.

Status: Draft, 5. March 2015 08:47

– Infinity Acute Care System

Workstation Critical Care and

Neonatal Care

– Infinity Acute Care System

Evita Infinity V500

– Infinity Acute Care System

Babylog VN500

–EvitaV300

Supplement to instructions for use

This supplement applies only to the listed medical

devices and updates the information of the respec-

tive instructions for use. Each chapter indicates the

medical devices to which the information applies.

Keep this supplement with the current instructions

for use of the respective medical device.

Where changes to screen content affect all of the

medical devices, the screen is displayed which

shows the maximum number of functions.

Devices delivered as of July 22, 2014 meet the re-

quirements of the 3rd edition of the IEC 60601-1

standard.

Typographical conventions

Applies to:

– Workstation Critical Care and Neonatal Care

– Evita Infinity V500

– Babylog VN500

–EvitaV300

Use of terms

Dräger uses the term "Accessory" not only for ac-

cessories in the sense of IEC 60601-1, but also for

consumable parts, removable parts, and attached

parts.

The designation "Infinity Acute Care System" is

omitted hereafter in this document.

Medical device Part number of

instructions for use

Infinity Acute Care System

Workstation Critical Care and Neonatal Care

9052077

Infinity Acute Care System

Evita Infinity V500

9052161

Infinity Acute Care System

Babylog VN500

9038982

Evita V300 9052995

For your safety and that of your patients

General safety information

Applies to:

– Workstation Critical Care and Neonatal Care

– Evita Infinity V500

– Babylog VN500

– Evita V300

Device combinations

This device can be operated in combination with

other Dräger devices or with devices from other

manufacturers. Observe the accompanying docu-

ments 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 or-

ganization 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, software-con-

trolled functions)

– IEC 60601-1-2 (electromagnetic compatibil-

ity)

– IEC 60601-1-8 (alarm systems)

Or:

– IEC 60601-1, 2nd edition (general require-

ments for safety)

– IEC 60601-1-1 (device combinations)

– IEC 60601-1-2 (electromagnetic compatibil-

ity)

– IEC 60601-1-4 (software-controlled func-

tions)

– IEC 60601-1-8 (alarm systems)

Training

Training for users is available via the Dräger organ-

ization responsible (see www.draeger.com).

For your safety and that of your patients

Product-specific safety information

Applies to:

– Evita Infinity V500

– Babylog VN500

–EvitaV300

WARNING

Risk of malfunction

Unauthorized modifications to the medical de-

vice lead to malfunctions.

This medical device must not be modified un-

less authorized by the manufacturer.

WARNING

Risk of fire

The use of unapproved O2pressure 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.

WARNING

Risk of unnoticed change in inspiratory O2

concentration

If an additional flow is delivered by an external

flow source, the actual O2concentration deliv-

ered may deviate from the displayed values.

Use additional monitoring, e.g., external SpO2

monitoring, if necessary.

WARNING

Risk of patient injury

If leakages are present, e.g., with non-invasive

ventilation, the actual tidal volume may devi-

ate from the measured values for VTe and VTi.

Activate leakage compensation and monitor

the measured value for VT. Minimize or rem-

edy all leakages.

CAUTION

Risk of patient injury

An additional flow delivered by an external flow

source can affect the measured values for airway

pressure and flow.

CAUTION

Risk of malfunction

The touch screen has a sensitive surface. Dam-

age to the surface may cause the touch-sensitive

controls not to work properly.

Do not operate the screen with sharp objects.

Application

Applies to:

– Evita Infinity V500

– Babylog VN500

– Evita V300

Environment of use

Do not operate the device with helium or helium

mixtures.

Overview

Applies to:

– Evita Infinity V500

– Babylog VN500

–EvitaV300

Range of functions

Connecting accessories

Accessories can be attached to the following hold-

ers:

– Universal holder with standard rail (G93140)

– Humidifier holder, can be swiveled (G93111)

– Humidifier holder, side rail (8416325)

Observe the permitted maximum distance to the

trolley and the permitted maximum load, see "Max-

imum loads of holders" on page 8.

Abbreviations

Abbreviation Explanation

BTPS Body Temperature Pressure Satu-

rated, measured values based on

the condition of the patient's lungs,

body temperature 37 °C (98.6 °F),

water vapor-saturated gas, ambi-

ent pressure and airway pressure

Vds Serial dead space,

volume up to CO2cuvette

Overview

Symbols

Symbol Explanation

Attention!

Warning! Strictly follow these

instructions for use.

Label with notice: "Transport

within the hospital"

Nominal weight and maximum

weight (for information, see

chapter "Technical data")

Temperature limitation during

storage

Ambient pressure

Relative humidity

Use by

Keep dry

nom. 58 kg (128 lbs)

max. 133 kg (293 lbs)

Assembly and preparation

Applies to:

– Evita Infinity V500

– Babylog VN500

–EvitaV300

Safety information

Prepare trolley 2 – 90 cm

Securing accessories to the standard

rail

Maximum loads of holders

The following information applies to the holders:

WARNING

Risk of tipping over

Do not tilt the device by more than 5°.

Holder Position of the holder Maximum

load

Possible accesso-

ries

Maximum distance

to side rail

Universal holder

with standard rail

(G93140)

On the front of the trol-

ley

10 kg

(22 lbs)

Breathing gas humid-

ifier, medication neb-

ulizer

–

Humidifier holder,

can be swiveled

(G93111)

On the side of the trolley 5 kg

(11 lbs)

Breathing gas humid-

ifier

–

Humidifier holder,

side rail (8416325)

On the side rails of the

ventilation unit1)

1) Maximum load on the side rails of the ventilation unit: 5 kg (11 lbs) per side rail

5kg

(11 lbs)

2) If a hinged arm is attached to the side rails of the ventilation unit in addition to the humidifier holder (8416325), the maximum

load of 5 kg (11 lbs) per side rail must be observed. The humidifier holder can then only support 4 kg (8.8 lbs).

Breathing gas humid-

ifier

10 cm (3.9 in)

IACS hinged arm

(MP00690)

On the side rails of the

ventilation unit1)

1kg

(2.2 lbs)

Breathing hoses 100 cm (39.4 in)

Assembly and preparation

Preparing the Medical Cockpit

Using the MEDIBUS or the MEDIBUS.X

protocol

Preparing the ventilation unit

Safety information for the use of HMEs,

bacterial filters, and breathing circuits

Installing a neonatal flow sensor

If a neonatal flow sensor and HME are used in the

patient categories Neo. or Ped. pat., the HME must

be installed between the neonatal flow sensor and

the patient connection.

WARNING

Risk of patient injury

All data transferred via the MEDIBUS interface

are for information only and must not be used

as the sole basis for diagnostic or therapeutic

decisions. The MEDIBUS interface is not in-

tended for use with a distributed alarm system

according to IEC 60601-1-8:2012.

CAUTION

Additional components in the breathing circuit

such as bacterial filters, HME or CO2cuvettes

may increase the dead space, compressible vol-

ume, and resistance.

Particular care and monitoring are required when

using additional components.

Before checking the breathing circuit (see instruc-

tions for use, chapter "Getting started"), attach all

necessary additional components up to the pa-

tient connection.

WARNING

Increased resistance

Medication nebulization and active humidifi-

cation may increase the resistance of addi-

tional components.

Check the breathing circuit regularly for signs

of increased resistance and replace additional

components if necessary.

Assembly and preparation

Connecting the mains power supply

Connecting the nurse call

Transportation of patients within the hospital

When transporting the patient within the hospital,

grasp the trolley handle firmly and push the device

in longitudinal direction.

WARNING

Risk of electric shock and of device failure

If the device is connected to a power socket

with incorrect mains voltage or without a pro-

tective ground, the user can be injured and the

device damaged.

Only connect the power cable to power sock-

ets with a protective ground and the correct

mains voltage. Observe the technical data.

NOTE

The mains power socket in use must be freely ac-

cessible during operation.

WARNING

Risk of patient injury

All data transferred via the nurse call are for

information only and must not be used as the

sole basis for diagnostic or therapeutic deci-

sions. The nurse call is not intended for use

with a distributed alarm system according to

IEC 60601-1-8:2012.

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