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.

Instructions for use – Infinity® M300 and M300+ series – VG3.0 11
For your safety and that of your patients
Connected devices
Networking and connection to other devices
When combining Dräger devices with other electrical devices, the owner must ensure that the resulting
system meets the requirements of the following standards:
– IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– 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
Strictly follow the Assembly Instructions and Instructions for Use for each connected device.
Connection to hospital network
Many medical devices manufactured by Dräger use networks to transmit patient data in real-time and to
notify clinical users of alarm conditions. Hospitals should refer to IEC 80001-1 before attempting to
connect such medical devices to their IT networks.
IEC 80001-1 requires manufacturers (such as Dräger) to make technical documentation in support of such
network connections available upon request. Contact your Dräger representative for that information or to
facilitate negotiation of an IEC 80001-1 Responsibility Agreement for additional support from Dräger.
WARNING
Risk of electric shock and of device malfunction
Any connected devices or device combinations not complying with the requirements mentioned
in these instructions for use can compromise the correct functioning of the medical device and
leads to an electric shock. Before operating the medical device, strictly comply with the
instructions for use of all connected devices and device combinations.

For your safety and that of your patients
12 Instructions for use – Infinity® M300 and M300+ series – VG3.0
Connection to other devices
Safe connection with other electrical equipment
Electrical safety
CAUTION
Combinations of Dräger devices and third-party devices that are not approved by Dräger may adversely
affect operation of those devices and may put the patient at greater risk of injury.
CAUTION
The medical device must only be used with software tested and approved by Dräger. Any modifications
of the operating system settings can impair operating safety. Responsibility for any such modifications
lies with the owner.
WARNING
To protect the patient from possible injury due to electrical shock, peripheral devices should only
be connected to a monitor within the same room. The installer or service provider should verify
that the leakage current of the interconnected system meets the electrical safety requirements
of IEC 60601-1.
The leakage current increases when multiple medical devices are connected to a patient. Make
sure that the electrical isolation of each device is suitable for the intended application. Only
equipment that is set up and tested according to IEC standards should be connected to the
analog and digital signal inputs and outputs.
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in these instructions for use or these assembly instructions
must only be made when approved by each respective manufacturer.
WARNING
Because of the danger of electric shock, never remove the cover of a device while it is in use or
plugged into a power socket.
CAUTION
To ensure that it is properly grounded, connect the power cord of the power supply to hospital-grade
electrical outlets only.

Instructions for use – Infinity® M300 and M300+ series – VG3.0 13
For your safety and that of your patients
Patient safety
The design of the medical device, the accompanying documentation, and the labeling on the medical
device are based on the assumption that the purchase and the use of the medical device are restricted to
persons familiar with the most important inherent characteristics of the medical device. Instructions and
WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical
device.
These instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the medical device
– Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous.
Patient monitoring
The user of the medical device is responsible for choosing a suitable patient monitoring system that
provides appropriate information on medical device performance and patient condition.
Patient safety may be achieved by a wide variety of means ranging from electronic surveillance of medical
device performance and patient condition to direct observation of clinical signs.
The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical
device.
General safety information
The following WARNING and CAUTION statements apply to general operation of the medical device.
WARNING and CAUTION statements specific to subsystems or particular 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.
See "Battery safety information" on page 54 for additional safety information.
CAUTION
To avoid injuring the patient, do not touch any connector or mounting screw on the device when you are
touching the patient. In addition, do not allow the conductive parts of electrodes and cables to contact
other conductive parts or ground.
WARNING
To properly use the M300 and M300+ medical device, read and comply with the latest instructions
for use and supplement.

For your safety and that of your patients
14 Instructions for use – Infinity® M300 and M300+ series – VG3.0
WARNING
Inaccurate SpO2 measurements may result under the following conditions:
– Elevated levels of methemoglobin
– Elevated levels of total bilirubin
– Excessive patient motion
– Severe anemia
– Low arterial perfusion
WARNING
Risk of electric shock and device malfunction.
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
Ensure that no liquid penetrates the device.
WARNING
Pacemaker considerations
False low-rate alarms can result under the following conditions:
– Asynchronous pacemaker with large amplitude pace pulses with no overshoot and at low
heart rate (30 bpm)
False high-rate alarms can result under the following condition:
– Asynchronous pacemaker with large pace pulse tails and at low heart rate (30 bpm)
CAUTION
Signs of wear, such as cracks, deformation, discoloration, or peeling, may occur with reprocessed prod-
ucts.
Check the products for signs of wear and replace them if necessary.
CAUTION
To avoid damaging the device, do not use sharp tools or abrasives. Never immerse electrical connectors
in water or other liquids.
CAUTION
Do not autoclave accessories.
WARNING
Risk of explosion and of chemical burns
Improper handling of batteries can result in explosions and chemical burns.
Do not throw batteries into fire. Do not force batteries open.

Instructions for use – Infinity® M300 and M300+ series – VG3.0 15
For your safety and that of your patients
Not for use in areas of explosion hazard
Information on electromagnetic compatibility
General information on electromagnetic compatibility (EMC) according to international EMC standard
IEC 60601-1-2:
Medical electrical equipment is subject to special precautionary measures concerning electromagnetic
compatibility (EMC) and must be installed and put into operation in accordance with the EMC information
provided on page 285.
Portable and mobile radio frequency communications equipment can affect medical electrical equipment.
WARNING
Follow local regulations for safe disposal of batteries. To prevent fire or explosion, never dispose
of batteries in fire.
WARNING
To avoid electric shock, inspect all cables before use. Never use cables that appear cracked,
worn, or damaged in any way. Doing so may compromise performance or put the patient at risk.
WARNING
When placing the device, make sure that adequate airflow exists. To prevent overheating,
position the device with at least 5 cm (2 in) of space all around.
CAUTION
To avoid injuring the patient, disconnect all sensors that will not be used during transport before moving
the patient.
CAUTION
Read all cleaning instructions (for example, originating from the disinfectant manufacturer and the hos-
pital) carefully before cleaning the device. Refer to the chapter entitled “Reprocessing” for device-spe-
cific cleaning instructions. Moisture may damage the circuits, compromise critical performance, and
present a safety risk.
WARNING
Risk of fire
The medical device is not approved for use in areas where combustible or explosive gas
mixtures are likely to occur.

For your safety and that of your patients
16 Instructions for use – Infinity® M300 and M300+ series – VG3.0
Site of operation
Only use devices (monitors, chargers, accessories, etc.) in areas that meet the environmental
requirements outlined in the Technical Data chapter.
WARNING
Do not connect connectors with an ESD warning symbol and do not touch their pins
without implementing ESD protective measures. Such protective measures may
include antistatic clothing and shoes, touching a potential equalization pin before
and during connection of the pins, or using electrically insulating and antistatic
gloves. All users concerned must be instructed in these ESD protective measures.
WARNING
Do not operate the device in the following areas: magnetic resonance imaging (MRI)
environments, aircraft, ambulance, home, or hyperbaric chambers.
WARNING
To avoid interfering with device operation, do not operate devices (monitors, accessories, etc.)
within 10 m (33 feet) of equipment that emits microwave or other high-frequency emissions.
WARNING
To minimize the risk of patient strangulation, carefully position and secure sensor cables. Also
position the sensor cables to minimize inductive loops.
WARNING
When placing the Infinity M300 and M300+, make sure adequate airflow exists. Do not cover the
device with blankets.
CAUTION
After extended exposure in a cold environment, acclimate the device carefully so that condensation does
not form on the electronic parts and damage the device.
CAUTION
To avoid damaging the touch-sensitive screen, do not allow sharp instruments to touch the front panel
of the devices.
WARNING
To avoid short-circuiting and otherwise damaging the device, Dräger recommends that no fluids come
in contact with the ICS devices when they are connected to a power socket. If fluids are accidentally
spilled on the equipment, remove the affected device from service as soon as possible and have tech-
nical personnel verify that patient safety is not compromised.

Instructions for use – Infinity® M300 and M300+ series – VG3.0 17
For your safety and that of your patients
Defibrillator precautions
The M300 and Bedside Charger are protected against high-frequency interference from defibrillators and
against 50-Hz and 60-Hz power line interference.
CAUTION
To prevent burns and electric shock due to rerouting of electrical current through electrodes, do not po-
sition the defibrillator pads near any electrodes or sensors.
CAUTION
Only defibrillate across the chest.
CAUTION
Using ECG electrodes and cables specified by Dräger protects the device from damage during defibril-
lation and reduces noise and other interference on the ECG waveform.
CAUTION
Remove all non-defibrillation-proof applied accessories prior to defibrillation. Failure to remove non-de-
fibrillation-proof applied accessories could potentially be harmful to both the patient and operator, as well
as other medical devices connected to the patient.

18 Instructions for use – Infinity® M300 and M300+ series – VG3.0
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Instructions for use – Infinity® M300 and M300+ series – VG3.0 19
Cybersecurity
Cybersecurity
Definition of cybersecurity terminology. . . . 20
Cybersecurity safety information . . . . . . . . . 21
Cybersecurity information and
recommendations. . . . . . . . . . . . . . . . . . . . . . 23
Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Cybersecurity incident response . . . . . . . . . . . 26
Product security information. . . . . . . . . . . . . . . 26
Infinity network configuration . . . . . . . . . . . . . . 27
Security modes of operation. . . . . . . . . . . . . . . 28
Network security troubleshooting and error
conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
M300/M300+ network error message. . . . . . . . 31
PSK security credential expiration . . . . . . . . . . 31
Network support matrix. . . . . . . . . . . . . . . . . . . 32

Cybersecurity
20 Instructions for use – Infinity® M300 and M300+ series – VG3.0
Definition of cybersecurity terminology
The following table lists the cybersecurity terms used in the instructions for use or displayed on the
M300/M300+ and/or ICS.
Term Description
ACS Application Control Service. ACS is a Dräger-specific network func-
tionality that allows remote control over the network or a patient moni-
tor.
Denial of service A situation where intended services or functions cannot be accessed
due to unavailable resource. It is usually caused by excess resource
consumption.
DSCP Differentiated Services (DiffServ) value set in an IP packet for classifi-
cation and management. DSCP is part of a Quality of Service (QoS)
implementation.
Legacy mode Disabled security protocol without authenticated and encrypted com-
munication between devices. Legacy mode is a non-preferred mode of
operation in which devices can operate without secure communica-
tions. When selected, authentication, integrity protection, and encryp-
tion will not be used for data in motion between devices on the Infinity
network.
Man-in-the-middle attack A type of security compromise where a third-party positions itself in the
communication path between two or more entities. It usually compro-
mises one or more of data authenticity, integrity and confidentiality.
Packet storm An excessive amount of traffic on a computer network. The network
congestion can delay or inhibit network communication between devic-
es. A packet storm could cause latency, potentially preventing network
communications between devices. It could also cause excessive load
on devices as they attempt to manage the adverse condition.
PDS Patient Data Service. PDS is a Dräger-specific network functionality
that allows physiological patient data to be transferred across a net-
work for other entities to consume.
PIN Personal Identification Number.
PSK Pre-shared Key. A PSK is a shared confidential phrase, code, or key
used as a credential to mutually authenticate the peers.
Secure mode A security protocol that enables authenticated and encrypted commu-
nication between devices. Secure mode is a preferred mode of opera-
tion in which devices operate with protected communication. This im-
plementation provides mutual authentication, integrity protection, and
encryption for data in motion between devices on the Infinity network.
Spoofing A situation when another entity identifies as a third-party by falsifying
authentication information. Strong authentication mitigates spoofing
attacks.