Dräger Infinity M300 series Bedienungsanleitung

Instructions for use

Infinity® M300 and M300+ Series

Software VG3.0

WARNING

To properly use this medical device,

read and comply with these

instructions for use.

Instructions for use – Infinity® M300 and M300+ series – VG3.0 3

Typographical conventions

Any text shown on the screen and any labeling on the device are printed in bold and italics, for example,

Printer setup.

The “greater than” symbol > indicates the navigation path in a dialog window.

In the example System setup > General settings, System setup represents the dialog window title

(which is often accessed by selecting a button), and General settings represents a horizontally aligned

tab within the selected window.

Screen images

Schematic renderings of screen images are used, which may differ in appearance or in configuration from

the actual screen images.

Use of terms

All references to M300 in these instructions for use include M300+ unless otherwise specified.

1Consecutive numbers indicate steps of action, with the numbering restarting with “1” for each new se-

quence 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.

ALetters in illustrations denote elements referred to in the text.

4 Instructions for use – Infinity® M300 and M300+ series – VG3.0

Trademarks

Trademarks owned by Dräger

The following web page provides a list of the countries in which the trademarks are registered:

www.draeger.com/trademarks

Trademarks owned by third-party manufacturers

All other brand or product names are trademarks of their respective owners, including, without limitation:

Trademark

ACE® (Arrhythmia Classification Expert)

Infinity®

Pick and Go®

TruST®

MCable®

MonoLead®

Trademark Trademark owner

BruTab 6S Brulin

Dispatch Clorox

Actichlor Ecolab USA

Incidin

Oxycide

TOFscan IDMED

Masimo Masimo Corporation

Masimo SET (Signal Extraction

Technology)

rainbow

Klorsept Medentech

Capnoline Medtronic

Microstream

Nellcor

OxiMax

Instructions for use – Infinity® M300 and M300+ series – VG3.0 5

Open-source software

Dräger devices that use software may use open-source software, depending on their setup. Open-source

software may be subject to different terms of license. Additional information regarding the open-source

software used in this device is available at the following web page:

www.draeger.com/opensource

Safety information definitions

User group requirements

The term "user group" describes the personnel responsible who have been assigned by the operating or-

ganization to perform a particular task on a product.

Duties of the operating organization

The operating organization must ensure the following:

– Every user group has the required qualifications (e.g., has undergone specialist training or acquired

specialist knowledge through experience).

– Every user group has been trained to perform the task.

– Every user group has read and understood the relevant chapters in this document.

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 inconveniences during operation.

6 Instructions for use – Infinity® M300 and M300+ series – VG3.0

User groups

Clinical users

This user group operates the product in accordance with the intended use.

Users have medical specialist knowledge in the application of the product.

Reprocessing personnel

This user group carries out the necessary activities to reprocess the product.

Reprocessing personnel has specialist knowledge in the reprocessing of medical devices.

Service personnel

This user group installs the product and performs the service activities.

Service personnel has specialist knowledge in electrical and mechanical engineering and experience in

the servicing of medical devices.

Where product specific knowledge or tools are required, the service activities must be carried out by spe-

cialized service personnel. The specialized service personnel was trained by Dräger for these service ac-

tivities on this product.

Abbreviations and symbols

Refer to "Device symbols" on page 61, and to "Abbreviations" on page 66 for explanations.

Product compatibility information

Contact DrägerService or specialized service personnel for product compatibility information.

Instructions for use – Infinity® M300 and M300+ series – VG3.0 7

For your safety and that of your patients

Mandatory reporting of adverse events . . . . . . 8

Strictly follow these instructions for use . . . . . . 8

Storing the instructions for use. . . . . . . . . . . . . 8

Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Unauthorized changes to hardware or

software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . .9

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Installing accessories . . . . . . . . . . . . . . . . . . . . 10

Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 10

Environment of Use . . . . . . . . . . . . . . . . . . . . . 10

Restrictions for use. . . . . . . . . . . . . . . . . . . . . . 10

Restriction of distribution . . . . . . . . . . . . . . . . . 10

Connected devices. . . . . . . . . . . . . . . . . . . . . . 11

Networking and connection to other devices . . 11

Connection to hospital network . . . . . . . . . . . . 11

Connection to other devices. . . . . . . . . . . . . . . 12

Safe connection with other electrical

equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . 12

Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 13

General safety information . . . . . . . . . . . . . . 13

Not for use in areas of explosion hazard . . . . . 15

Information on electromagnetic compatibility . . 15

Site of operation . . . . . . . . . . . . . . . . . . . . . . . .16

Defibrillator precautions . . . . . . . . . . . . . . . . . . 17

For your safety and that of your patients

8 Instructions for use – Infinity® M300 and M300+ series – VG3.0

Mandatory reporting of adverse events

Serious adverse events with this product must be reported to Dräger and the responsible authorities.

Strictly follow these instructions for use

Storing the instructions for use

Training

Training for users is available from the responsible Dräger organization. See www.draeger.com.

Unauthorized changes to hardware or software

WARNING

Risk of incorrect operation and of 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” and in conjunction with appropriate patient monitoring.

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.

WARNING

Risk of incorrect use

Instructions for use must be kept accessible for the user.

WARNING

Any changes or modifications to the device hardware or software must be performed exclusively

by service technicians authorized by Dräger. Any unauthorized change can decrease patient

safety, can void the user’s authority to operate the equipment, and will void the warranty.

Instructions for use – Infinity® M300 and M300+ series – VG3.0 9

For your safety and that of your patients

Maintenance

Accessories

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.

If the above is not complied with, medical device failure and patient injury may occur. Observe

chapter "Maintenance" on page 241.

Dräger recommends that a service contract is obtained with DrägerService or specialized service

personnel and that all repairs are performed by DrägerService or specialized service personnel.

For maintenance, Dräger recommends the use of authentic Dräger repair parts.

WARNING

Risk due to incompatible accessories

Dräger has only tested the compatibility of accessories listed in the current list of accessories.

If other accessories are used, there is a risk of patient injury due to medical device failure. Dräger

recommends that the medical device is only used with accessories listed in the current list of

accessories.

NOTE

Dräger accessories that come in contact with the patient do not contain natural rubber latex.

NOTE

At least once per year, check all cables, devices, and accessories for damage, and check patient

leakage currents, and all alarm functions.

For your safety and that of your patients

10 Instructions for use – Infinity® M300 and M300+ series – VG3.0

Installing accessories

Sterile accessories

Environment of Use

The device is intended to be used in an environment where patient care is provided by healthcare

professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine

when use of the device is indicated, based upon their professional assessment of the patient's medical

condition.

Restrictions for use

Restriction of distribution

Federal Law (U.S.) restricts this device to sale by or on the order of a physician.

CAUTION

Risk of device failure

Install accessories to the basic device in accordance with the instructions for use of the basic device.

Make sure that there is a safe connection to the basic device.

Strictly observe instructions for use and assembly instructions.

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.

Single-use accessories must not be reused, reprocessed, or re-sterilized.

CAUTION

This device is intended for use in health care environments only and exclusively by persons with specific

training and experience in its use.

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