Dräger Fabius plus Manuel du propriétaire

Supplement

Fabius plus

WARNING

To properly use this medical device,

read and comply with the

instructions for use and this

supplement.

Anesthesia workstation

Software 3.n

Supplement to the instructions for use

2 Supplement Fabius plus SW 3.n

Fabius plusAnesthesia workstation

Supplement to the instructions for use

Keep this supplement with the instructions for

use of the medical device.

The supplement updates the information of the

instructions for use in the following chapters:

Trademarks

The following trademarks have been added:

Device Part number Edition

Fabius Plus 9054673 Up to 1. Edition

Trademark Trademark owner

Actichlor®Ecolab

BruTab 6S®Brulin

Buraton®

Schülke & Mayr

Mikrozid®

Perform®

Descogen®Antiseptica

Dismozon®Bode Chemie

Klorsept®Medentech

Oxycide®Ecolab USA

Virkon®DuPont

Supplement Fabius plus SW 3.n 3

For your safety and that of your patients

General safety information

The following safety information has been added:

Accessories in sterile packaging

Electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special

precautionary measures concerning

electromagnetic compatibility. During installation

and before initial operation, follow the information

in section: "EMC declaration" (page 46).

This device can be affected by other electrical

devices.

CAUTION

Risk of medical device failure and patient injury

– Do not use accessories in sterile packaging if

the packaging has been opened, damaged,

or if there are other signs that the accessories

are not sterile.

– Reuse, reprocessing, and sterilization of

disposable products is not permitted.

WARNING

Risk due to electrostatic discharge

Malfunctions that endanger the patient may

occur if no protective measures against

electrostatic discharge are employed in the

following situations:

– When touching the pins of connectors

that carry the ESD warning symbol.

– When establishing connections with these

connectors.

To prevent malfunctions, observe the

following measures and train the relevant

personnel:

– Observe the ESD protective measures.

Such measures may include wearing

antistatic clothing and shoes, touching a

potential equalization pin before and while

making the connection, or using

electrically insulating and antistatic

gloves.

– Observe the requirements for the

electromagnetic environment. Observe

the following section: "Electromagnetic

environment" (page 46).

For your safety and that of your patients

4 Supplement Fabius plus SW 3.n

WARNING

Risk due to electromagnetic disturbance

Wireless communication devices (e.g.,

cellular phones) and medical electrical

equipment (e.g., defibrillators, electrosurgical

devices) emit electromagnetic radiation.

When such devices are operated too close to

this device or its cables, the functional

integrity of this device may be compromised

by electromagnetic disturbances. As a result,

the patient could be put at risk.

– Maintain a distance of at least 0.3 m (1.0 ft)

between this device and wireless

communication devices, to ensure that the

essential performance of this device is

fulfilled.

– Maintain an adequate distance between

this device and other medical electrical

equipment.

Supplement Fabius plus SW 3.n 5

For your safety and that of your patients

Product-specific safety information

The following safety information has been amended:

The following safety information has been deleted:

WARNING

Risk of tipping over during transport

The medical device may tip over if handled

incorrectly. Observe the following when

transporting the medical device:

– The medical device may only be moved by

people who have the physical ability to do

so.

– To improve the maneuverability, transport

the device with 2 persons.

– When transporting over inclines, around

corners, or over thresholds (e.g., through

doors or in elevators), make sure that the

medical device does not bump against

anything.

– Remove any devices mounted to the

holding arms or the top of the device.

– Clear the writing tray and slide it

completely into the device.

– Do not pull the medical device over hoses,

cables, or other obstacles lying on the

floor.

– Do not activate the brake while the

medical device is being moved.

– Use only the handles provided to push or

pull the device.

WARNING

Risk of device failure

The device can fail if the power supply is

interrupted.

Always connect the device on an

uninterruptible power supply.

Application

6 Supplement Fabius plus SW 3.n

Application

The MEDIBUS and Vitalink protocols

The following safety information has been amended:

The following safety information has been added:

Overview

Compact breathing system COSY (top view)

The following designation has changed:

WARNING

Risk of not hearing alarm signals

If the alarm volume is too low, alarm signals

may not be heard.

– Set the alarm volume loud enough so that

the alarm signals can be heard in the

environment where the device is located.

– The user must remain within earshot of

the alarm signals.

NOTE

The use of a serial interface for an analog or

optical link and the routing of data via the

MEDIBUS or Vitalink protocol to external

devices, systems, or networks (LAN, WLAN,

PDMS etc.) is the responsibility solely of the

system manufacturer or the operating

organization.

During operation, the alarms and indicators on

the anesthesia workstation are binding and must

be adhered to.

NConnection for sample gas return line

Supplement Fabius plus SW 3.n 7

Overview

The views of the power supply unit for the COSY heater have

changed:

Power supply unit for COSY heating (front view)

ALED indicator for COSY heating

BOn/Off switch

CFuse

21014

Overview

8 Supplement Fabius plus SW 3.n

Power supply unit for COSY heating (rear view)

APower inlet

BLED indicator for power supply

CCable clamp

21015

Supplement Fabius plus SW 3.n 9

Overview

Interface panel

The designation of the fuse and the power inlet has changed.

ACOM 1 port

BConnection for PEEP hose

CConnection for APL hose

DSocket for O2sensor

ESocket for airway pressure sensor

FSocket for flow sensor

GPower inlet with power fuses

HOn/Off switch

IFuse for internal battery

JPotential equalization pin

25301

Overview

10 Supplement Fabius plus SW 3.n

Ceiling-mounted version (optional)

The "Caution - Risk of tipping over" safety information has been

omitted and the following warning has been added in its place:

WARNING

Risk of tipping over

The ceiling-mounted version of the device

does not meet the requirements of ISO 80601-

2-13 and IEC 60601-1 with regard to tipping

stability and transport stability. Precautionary

measures must be taken. The medical device

may tip over if handled incorrectly.

– The medical device may only be moved by

people who have the physical ability to do

so.

– Use 2 persons to transport the device.

– Make sure that there is sufficient clear

space.

– Remove any devices mounted on attached

support arms or on the top of the device.

– Fold in the support arms.

– Clear the writing tray and push it in

completely.

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