Dräger Infinity M300 series User manual

Instructions for use
Infinity® M300 and M300+ Series
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
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.