Drager Infinity Delta Instructions For Use (IFU)
Drager Infinity Delta Instructions For Use (IFU)
Drager Infinity Delta Instructions For Use (IFU)
Serious adverse events with this product must be reported to Dräger and the responsible authorities.
Safety information
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.
Target groups for this product include users, service personnel, and experts.
These target groups must have received instruction in the use of the product and must have the necessary
training and knowledge to use, reprocess, maintain, or repair the product. Contact Dräger for training
options.
The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target
groups.
Users
Users are persons who use the product in accordance with its intended use.
Service Personnel
Service personnel are persons who are responsible for the maintenance of the product. Service personnel
must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.
Experts
Experts are persons who perform repair or complex maintenance work on the product. Experts must have
the necessary knowledge and experience with complex maintenance work on the product.
Training
Training for users is available via the responsible Dräger organization (see www.draeger.com).
WARNING
Risk of serious personal injury, death or property damage.
The monitor can detach from the docking station and fall if:
– the mount is faulty
– the monitor is not securely locked in the docking station
If any part of the docking station appears faulty, do not install it or attach a monitor to it. Contact
your hospital’s service personnel.
Follow the installation instructions provided with the mount.
Position the docking station in a safe location away from the patient.
To prevent the monitor from falling, ensure that it is securely locked in the docking station.
When securely locked, the Battery Charge indicator located on the lower-left front panel of the
monitor is lit.
For more information on docking the monitor, see the main IFU.
Introduction
Starting with Delta VF10.1, the following VGA Display requirement has been removed from the Display
Unit (Kappa only) table under the Displays heading.
Output resolution:
High resolution mode: 1024 x 768
Medium resolution mode: 800 x 600
Low resolution mode: 640 x 480
System Components
Corrected vulnerabilities that may cause device to reboot, lose functionality, and/or lose communication.
Base Unit
Monitor Setup
Date & Time is no longer a selection in the Main Menu > Monitor Setup > Monitor Options submenu.
Date and time changes are only permitted by qualified hospital technical personnel or Dräger Service
personnel in the password-protected Service menu.
Unit Manager
The Unit Manager menu lets supervisory personnel configure monitoring functions for the clinical staff.
Access to this menu is restricted by a password.
Device Markings
The following table contains symbols that have been modified or added to the table in the section on
device markings in the main IFU.
Biomed
Temperature Display
All temperature readings appear on the main screen according to their position in Parameter Priority (see
page 2-6). The following display conventions govern temperature labels and values.
The monitor displays temperature values in one parameter box for each pod connector (MultiMed, He-
mo2/Hemo4). The variables “a” and “b” denote the first or second probe connector from the MultiMed with
Y-cable, NeoMed, Hemo2, Hemo4 pod or the MPod – Quad Hemo. When acquired via the MultiMed or
NeoMed pod, temperature signals are displayed as Ta <value> or Tb <value>. (If you are using a MultiMed
without a Y-cable, only Ta displays a value.)
When monitoring temperature using the Hemo2, Hemo4 pod, or the MPod – Quad Hemo, temperature
values are further identified according to where they are connected to the monitor. The temperature value
corresponding to the device hooked up to the Aux/Hemo2 PodCom connector is labeled T2a or T2b, while
the temperature value corresponding to the device hooked up to the Aux/Hemo3 connector is labeled T3a
or T3b.
NOTE
The transient response time for the monitor is less than 2.5 seconds.
Network Applications
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 85
Electromagnetic Compatibility (EMC). . . . . . . . 85
Electromagnetic Emissions . . . . . . . . . . . . . . . 88
Electromagnetic Immunity . . . . . . . . . . . . . . . . 89
Recommended separation distances . . . . . . . . 90
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 91
General information . . . . . . . . . . . . . . . . . . . . . 91
Electromagnetic environment . . . . . . . . . . . . . . 91
Recommended separation distances from
wireless communication devices . . . . . . . . . . . 92
The Condition for the Duplicate Address message should read as follows:
More than one monitor configured for the same IP address.
CAUTION
If the Duplicate Address network message is displayed, contact your Biomed or local DrägerService.
Remote View
Remote view of an IACS or M540 monitor from a Delta Series Monitor may not display all of the
information properly. Refer to the primary source device for all diagnostic and therapeutic decisions.
Remote view of a Delta Series Monitor from an IACS or M540 monitor may not display all of the
information properly. Refer to the primary source device for all diagnostic and therapeutic decisions.
Connections to IT networks
In an IT network, data can be exchanged by means of wired or wireless technologies. An IT network can
be any data interface (e.g., RS232, LAN, USB, printer interface) that is described in standards and
conventions.
During operation, this device can exchange information with other devices by means of IT networks and
supports the following functions:
– Display of waveforms and parameter data
– Signaling of alarms
– Recording, storing, and printing
– Remote control (e.g., alarm management)
– Bed view by remote access
– Access to saved patient data
– Transfer of device settings and patient data
Connecting this device to a network that incorporates other devices or making subsequent changes to that
network can lead to new risks for patients, users, and third parties. Before the device is connected to the
network or the network is changed, these risks must be identified, analyzed, and evaluated, and
appropriate measures taken.
Examples of subsequent changes to the network:
– Changing the network configuration
– Removing devices from the network
Prerequisites
This device must only be connected to the network by service personnel. The IT representative of the
hospital must be consulted in advance.
The following documents must be observed:
– Accompanying documents of this device
– Descriptions of the network
– Description of the network-based alarm systems
Dräger recommends complying with IEC 80001-1 (risk management for IT networks with medical
devices).
LAN networks
– LAN networks are usually configured in a star topology. Individual devices can be combined into groups
by means of layer-n-switches. Other data traffic is decoupled by means of separate VLAN networks.
Configure the network settings of the device in accordance with these instructions for use and the network
specifications.
– Specifications for LAN connections are described in the following standards:
– Wired networks: IEEE˽802.3
– Wireless networks: IEEE˽802.11 (b, g)
– If the device is used with a layer-2-switch or a layer-3-switch, the port settings must be configured on
the network switch. Before the device is shipped, Dräger can configure the network settings of the
device so that they are compatible with the specifications of the operating organization.
– This device exchanges data with other medical devices over the LAN network. The network must
support the following transmissions and protocols:
– TCP/IP
– Unicast (static or dynamic addressing with the ARP or RARP network protocols)
– Multicast
– Broadcast
– IGMP (version 2)
This device can join or leave an IP multicast group by using the IGMP network protocol.
VLAN networks
If data is being exchanged within a single physical network and a clinical information system is used, an
independent VLAN network must be set up for the clinical information system. Additionally, at least one of
the following independent VLAN networks must be set up:
– Network for medical devices for intrahospital use
– Network for portable patient monitors
WLAN networks
– On Dräger devices, the Advanced Encryption Standard (AES) WPA2 with pre-shared key
administration is used during installation.
– With some Dräger clinical devices, the installation is carried out using SSL and additional functions
that are defined in the form "Manufacturer Disclosure Statement for Medical Device Security" (MDS2).
Serial interfaces
The following interfaces are supported:
– RS232 interfaces conforming to EIA RS232 (CCITT V.24/V.28) for the following applications:
– MEDIBUS, MEDIBUS.X
– Paging systems
– Connections to medical devices from other manufacturers
– Interfaces conforming to IEEE˽1073 (Medical Information Bus) for connection to medical devices from
other manufacturers
The requirements of IEEE 1073.3.2 or the combined requirements of IEEE 1073.3.1 and IEEE
1073.4.1 must be complied with.
1 Hold the monitor firmly by its handle. Slide the lever to the left to disengage the power supply. The mon-
itor automatically switches to battery power.
2 Continue to move the lever to the left until it clicks. Use both hands to tilt the monitor forward and lift it
off the IDS or Docking Station.
3 When docking and undocking the monitor to and from an IDS, a minimum 15 second delay between
undocking and redocking the monitor is required, for loading the default IDS profile to the monitor.
Power Sources
Battery Power
The following information refers to the table on battery charge display as described in the main IFU.
NOTE
When the internal battery has approximately 20 minutes remaining, a low priority alarm sounds and
the message Monitor Internal Battery Low appears. The alarm can be silenced; however, the
banner message remains visible.
NOTE
To change the patient’s category (adult, pediatric, or neonatal), you must access the Patient
Setup menu at the bedside monitor.
If you change a patient’s category, the weight selection is cleared and must be entered again.
In neonatal mode, additional settings (gestational age and birth weight) are available at the
bedside monitor only. Day of Life and corrected GA values also appear in a read only field.
Entries and changes regarding a patient’s height and weight affect all other monitor menus and
displays that use this information.
For more information on admission at the Delta, see the Instructions For Use for the Delta
monitor.
Dräger recommends that patients be admitted at the Infinity CentralStation.
Alarms
Parameter Predefined Alarm Range and Default State Default Alarm Setting
Resolution
inCO2/inCO2* 2 to 10 mmHg (0.3 to 1.3 kPa) (upper ON High: 4 mmHg (0.5 kPa)
limit only) increments of 1 mmHg or
0.1 kPa
PLS 30 to 240 in increments of 5 bpm ON Adult:
Low 45 bpm
High 120 bpm
Pediatric:
Low 50 bpm
High 150 bpm
Neonatal:
Low 80 bpm
High 180 bpm
Auto Set Sets alarm limits based on current values: Not applicable
The monitor stores up to 50 physiological alarm events for each patient (the oldest log entry is overwritten).
Events are deleted when the patient is discharged. Data is stored in the monitor and remains with the
patient during Pick and Go transports. Data also survives power shutdowns. The Alarm History table
records all high-priority and medium-priority alarms as well as selected low-priority alarms for MultiGas
and Dräger Mainstream CO2 monitoring (e.g., alarms relating to module disconnection). The Alarm
History table also records every activation and deactivation of cardiac bypass mode, every change of
patient category, and records whenever you perform an All Alarms OFF/All Alarms Paused or Audio
Paused/Alarm Silence. Switching the device on and off is not recorded.
Alarm Latching
Some alarms are latched: they continue to annunciate visually and audibly until you acknowledge them
manually, even if the condition that caused the alarm no longer exists. Other alarms may be latched only
partially, as indicated in the following table:
NOTE
High-priority and medium-priority alarms do not
latch in OR mode.
To acknowledge (or silence) a latched alarm, press the Alarm Silence fixed key.
The monitor identifies QRS complexes with amplitudes between 0.2 and 5.0 mV and a QRS width of 70
to 120 ms for adults (or 40 to 120 ms for neonates). It calculates heart rates within a range of 15 to 300
beats per minute, using the R-R intervals of the last 10 seconds and diisregarding the two longest and two
shortest R-R intervals. It averages the remaining intervals, and displays the result as the current heart rate
in the HR parameter box on the main screen.
ECG Leads
The number of available ECG leads depends on the type of pod and cable set you are using, as shown
in the following tables.
Number of
ECG Pod Channels Leads Available
Lead Wires
NeoMed 3 lead ECG1 I, II, III3
MultiMed 5 3 lead ECG1 I, II, III2
12 lead ECG1, ECG2, ECG3 1 I, II, III, aVR, aVL, aVF, V1-V6 2
1
ECG3 is available only when HR, ARR, and ST parameter boxes are on the main screen.
2
V and V+ are V2 and V5 chest leads with 6 and 12 lead; aVR, aVL, and aVF are augmented
leads.
3
I or II or III are labeled on the ECG cable as RA, LA, LL
Arrhythmia Monitoring
Parameter Alarm Priority Rate (default) Count (default) Alarm Archive Factory
Default Default Setting
ASY HIGH Not adjustable Not adjustable Str./Rec.
VF HIGH Not adjustable Not adjustable Str./Rec.
VT HIGH 100 to 200 (120) 5 to 15 (10) Str./Rec.
Increments of 10 Increments of 1
RUN MED Not adjustable (VT Not adjustable (3 to Str./Rec.
rate) VT rate - 1)
AIVR MED Not adjustable = (VT Not adjustable (3) OFF
rate - 1)
SVT MED 120 to 200 (150) 3 to 10 (3) Str./Rec.
Increments of 10 Increments of 1
TACH MED 100 to 200 (130) 5 to 15 (8) OFF
Increments of 10 Increments of 1
BRDY MED 30 to 105 (50) Not adjustable (8) OFF
Increment of 5
CPT LOW Not adjustable Not adjustable Str./Rec.
BGM LOW Not adjustable Not adjustable Str./Rec.
PAUS OFF 1 to 3.5 (2.5) Not adjustable OFF
Increments of 0.5
ARTF OFF Not adjustable Not adjustable OFF
NOTE
When in neonatal mode or pediatric mode with Basic Arrhythmia monitoring, bradycardia is a high priority
heart rate alarm that is adjustable.
Respiration
Overview
The monitor can acquire and process non-invasive blood pressure (NBP) signals and display the results
for neonatal, pediatric, and adult patients. NBP accuracy was established using intra-arterial blood
pressure monitoring as a reference (within the limits prescribed by the Association for Advancement of
Medical Instrumentation, Electronic Automated Sphygmomanometers). Accuracy testing references used
the femoral artery for adults, and the umbilical, brachial, radial, or femoral arteries for pediatric and
neonate patients. NBP measurements for accuracy testing occurred on the same limb. NBP effectiveness
for pregnant and pre-eclamptic patients has not been established according to ISO 81060-2.
The accuracy is compromised with patients having dysrhythmias, arterial sclerosis, experiencing seizures,
or any type of cardiac or vascular malformation which results in an abnormal arterial waveform. Blood
pressure measurements are determined by the oscillometric method. Once the cuff has been inflated to
occlude the blood flow through the patient’s limb, the cuff is deflated in a controlled manner. As the cuff
pressure decreases, the oscillations increase in amplitude and then decrease as blood returns to normal
flow. From this change in amplitude, the mean arterial blood pressure can be directly determined and
systolic (S) and diastolic (D) blood pressures derived.
A B C
E D
NOTE
This illustration provides a general description that can be applied to all cuffs. For additional information,
see the instructions for use included with your NBP cuff, as applicable.
NBP Setup
NOTE
The accuracy of the oscillometric blood pressure signal can decrease (up to loss of measurement)
under the following conditions:
– Weak pulses
– Irregular pulses
– Patient movement artifacts
– Tremor artifacts
– Respiratory artifacts
– Pulses generated from a ventricular assist
device
These conditions may prevent the monitor from performing a measurement within the maximum
allowable measurement time.
Kappa
Delta/Delta XL
Venous Stasis
Available in software levels equal to or greater than VF9.1, and supports venous stasis in adult mode only
(with adult-based inflation pressures).
Status Messages
NBP Cannot The pulse profile is too poor to make a • Check the patient and treat, if
Measure reliable measurement (usually due to necessary.
persistent motion artifact). • Move the cuff to a limb with less
movement.
• Restart measurement. If the
message persists, contact the
hospital’s technical personnel or
DrägerService.
• Take a manual measurement if the
condition persists.
NBP A measurement was aborted (usually • Repeat the measurement.
Measurement due to motion artifact) because it lasted • Take a manual measurement if the
Timeout longer than two minutes (adult or condition persists.
pediatric) or 90 seconds (neonatal).
A
C
E
G B
NOTE
During CNAP measurements, the NBP Interval Time (5, 10, 15 min) is disabled and controlled by the
Auto CNAP Relearn menu.
CNAP Calibration
Each time a CNAP measurement starts or the inflation pressure alternates between the dual finger cuffs,
CNAP automatically calibrates. Calibration consists of a pulse determination phase followed by an NBP
correlation measurement. During calibration a triangular wave (for pod firmware version 2.14.14.) displays
in the CNAP waveform area and then the message CNAP @ Calibrating displays and the CNAP values
are blank. After a successful NBP measurement, the CNAP waveform and CNAP values display.
NOTE
A “rectangular” or “square” waveform displays for previous firmware versions.
Status Messages
Maintenance (CNAP)
Overview
This chapter describes the maintenance measures required to maintain the proper functioning of the
medical device. Maintenance measures must be performed by the responsible personnel.
WARNING
Risk of infection
Users and service personnel can become infected with pathogenic germs.
Disinfect and clean the device or the device parts before any maintenance measures and also
before returning the medical device for repair.
WARNING
Risk of electric shock
Components that carry current are located under the cover. Do not remove the cover.
Maintenance measures must be performed by the responsible personnel. Dräger recommends
DrägerService to perform these measures.
WARNING
If the device is mechanically damaged, or if it is not working properly, do not use it. Contact your
hospital's technical personnel. Never perform monitor service or maintenance activities while
actively monitoring a patient.
CAUTION
This device must be inspected and serviced at regular intervals. A record must be kept on this
preventive maintenance. We recommend obtaining a service contract with DrägerService through your
vendor. For repairs we recommend that you contact DrägerService.
CAUTION
When servicing devices from Dräger, always use replacement parts that are qualified to Dräger
standards. Dräger does not warrant or ensure the safe performance of third-party replacement parts for
use with the devices.
CAUTION
If you spill liquid on the equipment, battery, or accessories or immerse these components in liquid, allow
them to dry completely for at least 24 hours to 48 hours. Contact your hospital's technical personnel to
test whether any such component is fully operational before putting it back in clinical use.
Concept Definition
Maintenance All measures (inspection, preventive maintenance, repair) intended to maintain and
restore the functional condition of a medical device.
Inspection Measures intended to determine and assess the actual state of a medical device.
Preventive Recurrent specified measures intended to maintain the functional condition of a medical
Maintenance device.
Repair Measures intended to restore the functional condition of a medical device after a device
malfunction.
Inspection
Visual Inspection
Perform a visual inspection before every use and in accordance with your hospital's policy.
1 Make sure that the housing is not cracked or broken and there are no signs of spilled liquids or
damage.
2 Inspect all accessories (for example, sensors and cables). Do not use if there are any signs of damage.
3 Examine all system cables and power plugs and discontinue use if there are any signs of damage.
4 Inspect all patient cables, leads, and strain reliefs for general condition. Make sure the connectors are
properly engaged at each end.
Inspection and safety checks of devices must be performed according to suggested intervals.
WARNING
Risk of medical device failure
If safety checks are not performed on a regular basis, the proper operation of the medical device
can be compromised. Perform safety checks at the indicated interval.
– Perform device checks (for example, calibration of pod with cuff controller, sensor cuff, and NBP
cuff)
– Check/Visual inspection
3 Check that the device combination is in good condition:
– All labels are complete and legible
– There is no visible damage
4 Use the instructions for use to check that all components and accessories needed to use the product
are available.
5 Check the electrical safety requirements according to IEC 62353.
Metrological checks
If required by applicable regulations, the following measurement functions must be checked every two
years by qualified DrägerService personnel:
– Body temperature
– Non-invasive blood pressure
Preventive Maintenance
WARNING
Risk of faulty components
Device failure is possible due to wear or material fatigue of the components. To maintain proper
operation of all components, this device must undergo inspection and preventive maintenance
at specified intervals.
WARNING
Risk of electric shock
Before performing any maintenance work, disconnect all electrical connectors from the power
supply.
Calculations
The following table lists the parameter labels that have been updated in the Calculations chapter.
WARNING
A pulse oximeter should be considered an early warning device. If a trend towards patient
hypoxemia is observed, blood samples should be analyzed by laboratory instruments to
completely understand the condition of the patient.
WARNING
The pulsations from intra-aortic balloon support can elevate the pulse rate. Verify the pulse rate
of the patient against the heart rate.
WARNING
Risk of patient injury
If the SpO2 sensor is used in the presence of significant concentrations of dyshemoglobins, such
as carboxyhemoglobin or methemoglobin, measurement accuracy may be reduced.
Do not rely on measurement data if the SpO2 sensor is used under these conditions.
WARNING
If the SpO2 sensor is used in the presence of elevated levels of bilirubin, measurement accuracy
may be reduced.
Do not rely on measurement data if the SpO2 sensor is used under these conditions.
WARNING
If the SpO2 sensor is used in the presence of intravascular dyes, such as methylene blue,
measurement accuracy may be reduced.
Do not rely on measurement data if the SpO2 sensor is used under these conditions.
WARNING
Risk of inaccurate data
In the presence of shock, low blood pressure, severe vasoconstriction, major anemia,
hypothermia, arterial occlusion proximal to the sensor, and asystole, the pulse rate may be
inaccurate.
WARNING
Risk of patient injury
High intrathoracic pressure, pressure on the thorax and other consecutive impairments of the
venous flow can lead to venous pulsation and pulse signal failure.
Do not position the SpO2 sensor where it might be affected in this way.
WARNING
To reduce the hazard of burns during surgery, keep the sensor or transducer and their
associated cables away from the surgical site, the electro-surgical unit return cathode, and the
earth ground.
CAUTION
For Masimo SET pod, after connection of the sensor, observe monitor for any messages if the sensor does
not light up. If the sensor LED does not light up, replace sensor and/or intermediate cable.
CAUTION
Refer to the “Pulse Oximetry (SpO2)” chapter in the Infinity Delta Series Instructions for Use for Software
VF9 for additional precautions regarding safe device operation.
CAUTION
Do not immerse the sensor or patient cable in any liquid. Moisture may present a safety risk.
NOTE
When in neonatal mode or pediatric mode with Basic Arrhythmia monitoring, bradycardia is a high heart
rate alarm that is adjustable.
The following status message applies to any monitor using a Masimo SET pod.
As of the Infinity Delta Series Software VF10.1 release, MicrO2+ is no longer supported.
Application
Intended Use
The Dräger Mainstream CO2 module, when connected to a monitor, allows the monitor to measure and
display mainstream etCO2 (end-tidal CO2), inCO2 (inspired CO2), and RRc (Respiration Rate) for
neonate, pediatric, and adult patients. Respiratory phases are determined from excursion of the CO2 data
through a threshold which is adaptively calculated from the CO2 curve. The maximum CO2 value during
the expiratory phase is taken as end-tidal CO2 (etCO2), immediately shown after each breath. The Dräger
Mainstream CO2 module cannot be used simultaneously with Scio Four modules.
WARNING
For premature infants, do not carry out CO2 measurements because the CO2 cuvette
significantly increases the dead space.
NOTE
The Dräger Mainstream CO2 module is compatible with Delta and Delta XL monitors. The Dräger
Mainstream CO2 module is not compatible with Kappa.
Precautions
WARNING
Risk of misinterpretation
Misdiagnosis or misinterpretation of the measured values or other parameters can endanger the
patient. Do not make therapeutic decisions based solely on individual measured values and
monitoring parameters. Therapeutic decisions must be made solely by qualified users.
WARNING
Risk to patient safety
The etCO2-related information displayed is intended to be used by trained and authorized health
care professionals only.
WARNING
Risk of inaccurate gas measurement values
During warm-up, reported values may not be accurate. Wait until the Dräger Mainstream CO2
sensor has completed initialization and warm-up.
WARNING
The etCO2, inCO2, and RRc alarms do not activate until the second breath is detected after
turning on the monitor or discharging a patient.
WARNING
RRc apnea alarms are NOT reported if the setting RRc Apnea Time is set to OFF in the etCO2
setup menu and the RRc alarm feature is deactivated. To generate RRc apnea alarms, activate
the RRc alarms and select an RRc apnea time.
WARNING
To minimize the risk of patient strangulation, carefully position and secure sensor cables.
WARNING
Patient monitors that measure CO2, anesthetic agents, and/or respiratory mechanics are not
intended to be used as an apnea monitor and/or recording device. While these products provide
an apnea alarm, that alarm condition is initiated based on the elapsed time since the last breath
was detected. Clinical diagnosis of a true apneic event, however, requires multiple physiological
signals.
WARNING
In an ambient temperature of 104 degrees F (40 degrees C), the CO2 mainstream sensor reaches
a surface temperature of 110 degrees F (43 degrees C).
WARNING
Do not use the CO2 mainstream sensor in an explosive or oxygen-enriched environment
(atmosphere) (100% oxygen is allowed in the measuring cuvette). Fire hazard!
WARNING
Risk of device failure and/or patient injury and user injury
Magnetic fields can negatively influence the correct functioning of the medical device and
therefore endanger the patient or user.
Do not use the medical device near magnetic resonance imagers (MRI, NMR, NMI).
WARNING
Do not use any explosive anesthetic agents (e.g., ether or cyclopropane). Fire hazard!
CAUTION
Leaks in the breathing circuit (for example, an uncuffed endotracheal tube or a damaged cuvette) may
significantly affect CO2 measurement values.
CAUTION
To avoid accidental disconnections, do not apply excessive tension to any sensor cable.
CAUTION
To prevent leakage, make sure the cuvette is firmly connected to the breathing circuit.
CAUTION
Check the CO2 mainstream sensor and measureing cuvette for damage before use. A damaged CO2
sensor may impair electrical isolation or may introduce debris into the breathing circuit.
CAUTION
Only use the mainstream CO2 sensor with the approved CO2 measuring cuvettes for adult or pediatric
applications. See the “Approved options and accessories” section. The measuring function may
otherwise be inaccurate.
NOTE
In this chapter, all Infinity Delta Series patient monitors are referred to as “patient monitor.”
NOTE
When etCO2, inCO2 or RRc is followed by * (for example, etCO2*), the * indicates the origin of this
parameter is from an external device such as an A500, A350, or A300.
Connection
Slide the Dräger mainstream CO2 module into the slot on the rear of the monitor until it rests securely.
D E
B
C
A Dräger mainstream CO2 module D Connection port for external SpO2 pod
B Infinity MCable - CO2 mainstream E External SpO2 pod
sensor cable connection
C Connection port for the CO2
module to monitor
Before you connect any CO2 hardware, make sure the cuvette setting of the monitor matches the cuvette
in use. For example, the Delta must be configured for a disposable cuvette if a disposable cuvette is being
used. Not aligning the configuration setting with the cuvette type compromises the displayed CO2 value.
CAUTION
The cuvette windows of the reusable cuvette have optical properties different from the cuvette windows
of the disposable cuvette. Therefore, select the cuvette type correctly; otherwise, the zero point shifts
by up to 8 mmHg CO2 (1.1 kPa CO2).
I G
CAUTION
Always use the mainstream CO2 measuring cuvettes with the windows in an upright position. Otherwise,
condensation deposits from the breathing system may collect, which could impair proper function.
Getting Started
CAUTION
The cuvette windows of the reusable cuvette have optical properties different from the cuvette windows
of the disposable cuvette. Therefore, select the cuvette type correctly; otherwise, the zero point shifts
by up to 8 mmHg CO2 (1.1 kPa CO2).
Initialization
Upon start-up, the sensor goes through a warm-up period (status message CO2 Warming Up appears).
During this time (approximately 30 seconds), concentrations for CO2 may not be available.
Device Conflicts
Source dialog
When Delta detects both a mainstream and SCIO device are connected, the Source dialog appears.
The user must select the preferred device from the dialog, or disconnect either the mainstream or SCIO
device to exit the screen lock.
To select the source of CO2 from the Source dialog:
– Dial to Mainstream or SCIO accordingly and click to select it.
NOTE
Delta continues to monitor the first device connected (mainstream or SCIO) until it is disconnected or
the alternate device is selected from the Source dialog.
NOTE
CO2* devices include the Dräger Scio Four modules or a device with etCO2* capabilities (e.g.,
ventilator, anesthesia machine) connected through MIB.
Display Features
etCO2 Monitoring
The etCO2 waveform displays the instantaneous CO2 concentration. The etCO2 parameter box displays
the following parameters:
– End-tidal CO2 (etCO2) — The level of CO2 in the airway at the end of expiration.
– Inspired CO2 (inCO2) — The level of CO2 in the airway during the inspiration phase.
– Respiration Rate (RRc) — The patient’s respiration rate, derived from the etCO2 signal by
calculating a n average rate over the two most recent breaths.
E
inCO2 C
D
F
NOTE
If alarms are disabled, crossed-out triangle icons appear next to the corresponding parameter values.
NOTE
The patient monitor does not alarm for etCO2 violations until it has established a valid respiratory rate.
etCO2 Setup
To access the etCO2 setup menu
Click on the etCO2 parameter box.
or
1 Press the Menu fixed key.
2 Click on Patient Setup.
3 Click on Parameters to display a list of available parameters.
4 Click on etCO2.
Smart Apnea
In OR mode only, the monitor automatically engages the Smart Apnea feature for RRc* apnea alarms if
RRc Apnea Time is set to a selection other than OFF in the etCO2 parameter menu.The Smart Alarm
feature escalates an apnea alarm in the following manner:
RRc Apnea Time in Alarm Priority Alarm Message Displayed Alarm History
Seconds
RRc apnea time None; Single attention tone RRc @ Apnea No
RRc apnea time * 2 None; Single attention tone RRc @ Apnea No
RRc apnea time * 3 Medium RRc @ Apnea Yes
RRc apnea time * 6 High RRc @ Apnea Yes
To illustrate, if RRc Apnea Time is set to 10 seconds and if an apnea alarm condition is present for
10 seconds, an attention tone annunciates and the alarm message RRc @ Apnea displays. If the apnea
alarm condition continues for 20 seconds, another attention tone annunciates and the alarm message
remains on the monitor. At 30 seconds, a medium-priority alarm annunciates. At 60 seconds a high-
priority alarm annunciates.
Capnograms
A
B
C
D
E
Zeroing
Perform the zeroing process once a day or when prompted to zero.
The zeroing operation is performed in ambient air with a clean Dräger mainstream CO2 sensor that is
removed from the cuvette.
1 Remove the Dräger mainstream CO2 sensor from the cuvette.
2 Select CO2 Zero under the etCO2 parameter menu. The monitor performs the zeroing operation and
displays a message that the CO2 zeroing is in progress. Waveforms flatline and parameter box values
disappear from the screen during this cycle.
3 Fit the Dräger mainstream CO2 sensor onto the cuvette.
If zero was successful, the monitor displays the message CO2 Zero Accepted after approximately
30 seconds. If zero was unsuccessful, the monitor displays the message CO2 Zero Failed. Repeat the
zeroing operation. If the zero remains unsuccessful, check whether the sensor is contaminated, clean it if
necessary, and re-zero. If the zero remains unsuccessful, the sensor may be defective and require
replacement.
Checking Calibration of the Dräger Mainstream CO2 Sensor with Test Filter
Perform the calibration check of the Dräger mainstream CO2 sensor with test filter at intervals of one
month.
Test filter
Starting the Calibration Check of the Dräger Mainstream CO2 Sensor with Test Filter
1 Remove the sensor from the cuvette and connect it to the test filter on the sensor cable.
2 Access the etCO2 parameter menu.
3 Select Calibration Check.
The monitor starts the check and displays the progress and result of the check in the message area.
If the check was successful
The monitor displays the message, Filter Check Successful. The test value is within the permissible
tolerance.
Fit the Dräger mainstream CO2 sensor back on the cuvette.
If the check was not successful
The monitor displays the message, Filter Check Failed. The test value is outside the permissible
tolerance.
Contact DrägerService.
Troubleshooting
If an alarm occurs, the following table helps to quickly identify causes and remedies. The possible causes
and remedial measures should be consulted in the order in which they are listed until the alarm is resolved.
Status Messages
Respiratory Mechanics
The following table lists the parameter labels that have been updated in the Respiratory Mechanics
chapter.
Display Features
NOTE
When FiO2 is followed by * (FiO2*), the * indicates the origin of this parameter is from a ventilator. For
more information on FiO2*, see the main IFU.
MultiGas Monitoring
If there is a secondary anesthetic agent already present while the Delta is admitted (taken out of
Discharge), that secondary agent is not trended. Powering on and admitting the monitor before starting
anesthetic gas measurements prevents this issue from occurring.
If the secondary anesthetic agent changes to the primary anesthetic agent, the agent is trended.
The Delta monitor can calculate an xMAC value from all SCIO Four modules (SCIO Four, SCIO Four Oxi,
SCIO Four plus, and SCIO Four Oxi plus).
The xMAC value is a simple navigation aid for anesthetic agent delivery.
The xMAC is the MAC multiple calculated from the current expiratory measured values and the age-
dependent MAC values.
MAC (minimum alveolar concentration) is the anesthetic gas concentration in the blood at 760 mmHg
(1013 hPa) at which 50% of patients no longer respond to a skin incision with movement. The integrated
xMAC algorithm is based on the MAC values shown in the following table. The MAC values are dependent
upon the age of the patient. The values specified in the table (according to ISO 80601-2-55) apply to a
patient age of 40 years.
NOTE
These values are guiding values only. The binding
values are specified on the package information
leaflet of the anesthetic agent.
The age-corrected MAC values are calculated using an equation developed by W. W. Mapleson (British
Journal of Anaesthesia 1996, pp. 179-185). The equation applies to patients older than 1 year.
The Delta series monitor allows the user to select whether Standard, Age-Corrected, or no xMAC
calculation is provided. The xMAC calculation is automatically adjusted according to the ambient pressure
measured by the gas analyzer. The influence of other drugs (opiates or intravenous hypnotics) is not
considered in the xMAC calculation.
NOTE
The xMAC Calc. selection in the Agent menu determines whether standard, age-corrected, or no xMAC
values are used.
NOTE
When connecting to a Dräger SCIO module or to a device using a protocol other than MEDIBUS.X:
– If Delta receives two anesthetic agents, xMAC displays locally only; it is not available on the network
for remote view or storage.
– If Delta receives one anesthetic agent, xMAC displays locally and is also available on the network
for remote view and storage, except that at ICS the xMAC value is shown without the label and in
Bed View only.
Connection to Dräger devices using MEDIBUS.X protocol does not have these limitations; xMAC from
those devices is available on the network and displays correctly, including at ICS Bed View and Main
Screen.
CAUTION
Risk due to incorrect setting for patient age
The patient’s age is derived from the birth date entered in the Patient Admit menu. Incorrect settings
can lead to inappropriate xMAC values and therefore to inappropriate anesthetic gas delivery.
Always set the patient age correctly.
Troubleshooting
Status Messages
Precautions
WARNING
To avoid serious injury to the patient, apply the stimulation electrodes close together as
described. Do not apply the electrodes
transcerebrally (across the head), directly over the eyes, covering the mouth, on the front of the
neck (particularly over the carotid sinus), trans-thoracically (across the chest), on the upper
back, or other position(s) that could place the electrodes over the heart. Doing so can cause
electrical current to enter the chest or head and may lead to irregularities in cardiac rhythm or
brain activity, or to pain.
Patient Preparation
Careful skin preparation is important to ensure appropriate electric contact for stimulation. Follow the
clinical techniques approved at your hospital for preparing the patient's skin prior to administering the
electrodes.
Precautions
WARNING
Do not use the PiCCO pod on patients for which placement of an indwelling arterial or central
venous catheter is contraindicated.
3 1 2 5
6 7
4
8
1 Initiates a zeroing of all connected 5 Transducer plate
pressures
2 Starts a p-CO measurement 6 Monitor connector (to pod communication
cable)
3 Transducer slots 7 CO connector
2
3
11
5
10
7 5
12 6
from Pulsion Medical Systems. Contact your local sales representative for ordering information.
1. Make sure the transducer is at heart level. Dräger recommends securing the transducer holders on
the front of the PiCCO pod for proper height.
2. Close the transducer stopcock to the patient and open it to air.
3(a). Click on the parameter box associated with the 3(b). Press the key on the
transducer you want to zero (ART, CVP, etc.). The hemodynamic pod/MPod to zero all pressures
parameter setup menu appears. whose transducers are open to air.
NOTE: You can also access the parameter menu as WARNING: Do not use the “Smart Zero”
follows: function if any pressure waveform is flat
1) Press the Menu fixed key to display the main (nearly static). Only use the “Smart Zero”
menu. function when all the stopcocks are opened
to air.
2) Click on Patient Setup.
NOTE: If you use this step, 3(b), and are
3) Click on Parameters. unable to zero a particular IBP with the
4) Scroll to the desired pressure parameter and click. key, use the associated parameter box as
described in 3(a). This method can be more
4. Click on Zero. effective.
NOTE: If the procedure is successful, the monitor displays the message: <IBP> @ Zero Accepted. If
the procedure fails, the monitor displays the message: <IBP> @ Did Not Zero. Check the waveform. If
spikes exceed three millimeters, repeat the procedure. If the procedure fails after two attempts, replace
the transducer or consult your hospital’s technical personnel.
NOTE
Make sure all patient connections are secure and that valid blood temperature and injectate
temperature readings are present before initiating a p-CO measurement.
15 Press the C.O. Start fixed key on the front of the PiCCO pod or p-CO Start in the PiCCO main
selection. A p-CO averaging screen appears. If you do not see a blood temperature baseline, exit the
screen and repeat this step.
NOTE
– In order to avoid disruption of p-CO thermodilution measurement, avoid connecting or
disconnecting any cables or changing any menus when measurements are in progress.
– During a measurement, if p-IT or p-BT readings become invalid or go out of range, the averaging
screen disappears.
– p-BT values are intended for p-CO thermodilution calibration and should not be used for the body
temperature of the patient.
16 Inject the bolus solution into the patient’s bloodstream only after you see the READY message. A
thermodilution curve appears, displaying the change in blood temperature, and a p-CO value is
computed.
NOTE
If the READY message fails to appear or appears only intermittently, the blood temperature may be
unstable. Check that all connections are correct and that the blood temperature is stable and valid, and
repeat step 15.
17 Repeat step 15 to take an additional measurement, making sure you wait for the READY message. If
a temperature drop is not detected within four minutes, the Averaging screen closes, and the current
p-CO values are averaged and saved. You must repeat steps 15 and 16 if additional p-CO
measurements are necessary.
CAUTION
When using PiCCO, the Filter setting in the ART menu should be set to 16Hz or 32Hz only. Using the
Filter setting of 8Hz may affect PiCCO measurement accuracy.
Amount of Bolus
15cc of iced injectate is normally adequate for most adult patients.
If room temperature injectate is used, it is recommended that 20cc of injectate be used.
CAUTION
The delivered injectate volume must always match the Injectate Volume setting in the
Thermodilution menu. Administering an injectate volume that is different from the Injectate Volume
setting can significantly affect the accuracy of the thermodilution measurement.
During a measurement, if p-IT or p-BT readings become invalid or go out of range, the averaging
screen disappears. Check that p-ITand p-BT are in range before restarting the measurement.
[p-IT range: -3 to 31 °C (27 to 88 °F),
p-BT range: 25 to 43 °C (77 to 109 °F)]
CAUTION
Recalibration of the thermodilution measurement is recommended at least every eight hours and with
significant changes in hemodynamic conditions such as volume shifts or changes to medication.
Analysis Tool
When receiving data from the Perseus A500, or Atlan A350/300, if the Analysis Tool is open and the
A500,A350, or A300 exits standby, the VTi parameter label is not displayed. Close and reopen the
Analysis Tool to restore the parameter label.
NOTE
“Analysis tool” replaces “Open Lung tool” throughout these instructions for use.
Overview
This chapter describes interfaces that can be used to connect the bedside monitor to peripheral devices
and supported ventilators and anesthesia systems. This chapter also describes the Analysis tool and the
Independent Surgical Display.
A monitor with compatible software displays waveforms and parameter values acquired from peripheral
devices via the general Medical Information Bus (MIB) interface protocol or the MEDIBUS.X interface
protocol. These protocols significantly expand the monitor's capabilities. The MIB protocol and the
MEDIBUS.X protocol require the monitor to be connected to an Infinity Docking Station (IDS).The
MEDIBUS.X interface protocol allows the peripheral device to be connected directly to the IDS. The MIB
interface protocol requires the MIB II protocol converter to connect the device to the IDS.
NOTE
MIB and MEDIBUS.X functionality is not available when the monitor is in DirectNet mode.
The Delta series monitor displays only a subset of the parameters supported by these devices but relays
all supported parameters to the infinity network and networked devices.
NOTE
Refer to the RS-232 export handbook for information on which parameters are available for export
protocol. The RS-232 export handbook is available in English only.
When a MEDIBUS.X device is in standby, the Delta series monitor does not process parameters, settings,
waveforms, or modes (i.e., this data is not displayed on the Delta series monitor and is not sent to the
Infinity network).
Parameter values acquired from peripheral devices are trended in graphical and tabular format. When you
modify the parameter display, a message identifies the trend data that will be lost if the trend storage
capacity is reached.
In the list of parameters available from specific peripheral devices later in this chapter, an asterisk (*)
identifies parameters that duplicate the monitor's parameters.
Consult device documentation for details on setup and operation.
Input: RS232, 25 Pin D
Input: RS232, 25 Pin D
Compatible devices
The following table lists the devices supported by the Delta series monitors.
NOTE
Delta series monitors support Medibus.X version 1.07.
MEDIBUS.X
Device MIB Interface Protocol Interface Protocol
MEDIBUS.X
Device MIB Interface Protocol Interface Protocol
WARNING
The above table lists all of the external devices that Dräger has validated. Dräger cannot make
any claim for the reliability of the data for any devices that have not been validated. In the interest
of patient safety and device performance, do not connect to the monitor devices which have not
been validated by Dräger. The hospital is responsible for contacting Dräger to determine the
compatibility and warranty status of any connection made to medical devices not listed in the
table.
NOTE
Delta series software VF10 and IDS software VF6.0 or higher support the MEDIBUS.X protocol for
integrating external device information into the monitor system and Infinity network.
MEDIBUS.X ventilators and anesthesia devices send parameters, settings, text messages or modes, and
waveforms to the network via the Delta series monitor.
NOTE
The Patient Category and Patient Category-specific settings align with the configured patient category
on the Delta monitor and are independent of that selected on the source device. The selected patient
category determines specific monitoring settings for the selected patient. Make sure you select the
appropriate patient category for the monitored patient on the Delta and the MEDIBUS X. device.
NOTE
The unit of measure displayed for each
parameter, waveform, and trend aligns with the
configured unit of measure on the Delta monitor
and is independent of that displayed on the
source device.
Precautions
See sections “Electro surgery” and “General Electrical Safety” for general precautions regarding device
operation.
CAUTION
– Data transferred using the MEDIBUS protocol or MEDIBUS.X protocol is for information only and
is not intended as a basis for diagnostic or therapeutic decisions. Always refer to the primary data
source for these decisions.
– Connecting peripheral devices is supported via the device connection option's RS232 connection.
Only connect peripheral medical devices to a patient monitor if those devices comply with the
electrical safety requirements found in IEC 60601-1. Refer to the Electrical Safety section for
information on how to connect devices safely.
NOTE
– The MIB II option will not work if a network cable is connected to it. Likewise the MIB II duo protocol
converter will not work if it is connected to an IDS network connector.
– An RJ-45 cable can plug into the MIB II duo protocol converter's X6 connector (MIB I output);
however, this cable cannot be removed if it locks into place (the protocol converter is unusable and
must be returned for service if this occurs). Only remove the label that covers the X6 connector if
the protocol converter is to be operated in MIB I mode.
NOTE
Refer to the instructions for use of the source
device for detailed information on external
parameters.
Refer to the instructions for use for your network
devices such as an Infinity CentralStation,
Innovian, Gateway, or Symphony for a list of
parameters transferred from the ventilator.
Refer to the "Atlan, Primus, Zeus, Apollo, and
Perseus Anesthesia Devices" section for detailed
information on those anesthesia devices, which
also provide gas monitoring.
The bedside monitor uses the airway pressure (Paw) and the ventilation (Vent) parameter boxes and
waveform channels to display ventilation parameter values, waveforms, and loops. Parameter values
acquired from the ventilator are trended in graphical and tabular form.
The ventilator provides the range and resolution for all parameters. Parameter settings, alarms, and error
messages do not display on the bedside monitor; they are displayed on the network device instead.
The monitor displays a ventilator pressure waveform next to the Airway Pressure (Paw) parameter box
and a ventilator flow waveform next to the Flow/Volume (Vent) parameter box.
For MEDIBUS.X devices, the monitor can also display the CO2 waveform next to the End-Tidal CO2
(etCO2*) parameter box.
NOTE
For information on calculating parameter values, see the documentation for the peripheral device you
are using.
CAUTION
The parameter abbreviations on the bedside monitor may differ from those displayed on the ventilator
(refer to the "Ventilation Parameters" table).
The bedside monitor displays pressure units in cmH2O while the ventilator displays pressure units in
mbar (1 cmH2O being equal to 1 mbar approximately).
Ventilation Parameters
The Delta/Delta XL/Kappa monitor displays data from the devices listed at the beginning of this chapter.
When the monitor is connected to an Infinity Primus, Apollo, Perseus,or Atlan anesthesia machine, it
displays the concentrations of CO2, O2, N2O, and anesthetic agents (Halothane, Isoflurane, Enflurane,
Sevoflurane, or Desflurane). The "Anesthesia Parameters" table lists all displayed parameters.
NOTE
The Infinity Primus and the Zeus anesthesia machines are not sold in the United States.
The monitor uses the multigas parameter box, etCO2* parameter box, and waveform channels to display
parameter values, waveforms, and loops. The agent parameter box displays agent concentrations for
anesthetic gases.
Parameter values acquired from the anesthesia machine are trended in graphical and tabular form.The
anesthesia machine provides the range and resolution for all parameters.
NOTE
The bedside monitor displays the xMAC (MAC multiple) values only if available and sent by the
connected anesthesia device.
Parameter settings, alarms, and error messages are not displayed on the monitor. They are displayed on
the network device such as an Infinity CentralStation, Innovian, Gateway, or Symphony instead. See the
Instructions for Use for your network device for the list of parameters transferred from the anesthesia
machine. Refer to the Primus, Apollo, Perseus,and Atlan instructions for use for details on calculating
parameter values.
Anesthesia Parameters
The monitor, when connected to a Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C via MIB,
displays cerebral oximetry.
NOTE
The Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C is now available in adult, pediatric,
and neonatal patient categories.
Reprocessing
The following information on reprocessing applies only to the Delta monitor. For information on
reprocessing for Delta accessories, please see the section on cleaning and disinfecting as described in
this supplement and the main IFU.
Information on reprocessing
Instructions for reprocessing are based on internationally accepted guidelines, e.g., standard ISO 17664.
Safety information
WARNING
Risk due to inappropriately reprocessed products
Reusable products must be reprocessed, otherwise there is an increased risk of infection.
– Observe the hygiene regulations and reprocessing regulations of the healthcare facility.
– Observe national hygiene regulations and reprocessing regulations.
– Use validated procedures for reprocessing.
– Reprocess reusable products after every use.
– Observe the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing
devices.
CAUTION
Risk due to faulty products
Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with reprocessed products.
Check the products for signs of wear and replace them if necessary.
Medical devices and their components are classified according to the way they are used and the resulting
risk.
Classification Explanation
Non-critical Components that come only into contact with skin that is intact
Semi-critical (A, B) Components that carry breathing gas or come into contact with mucous
membranes or pathologically altered skin
Critical (A, B, C) Components that penetrate skin or mucous membranes or come into contact with
blood
Non-critical
– Delta series monitors
Semi-critical A
– N/A
Semi-critical B
– N/A
Critical
– N/A
Reprocessing list
Reprocessing procedures
At the time of product-specific validation, the following reprocessing procedures showed good material
compatibility and effectiveness:
The effectiveness of the listed reprocessing procedures has been validated by independent laboratories
that are certified to the standard ISO 17025.
Disinfectants
Use disinfectants that are nationally approved and are suitable for the particular reprocessing procedure.
Surface disinfectant
At the time of the test, the surface disinfectants listed in the following table showed good material
compatibility. They can be used in addition to the surface disinfectants listed in the section "Validated
reprocessing procedures".
The manufacturers of the surface disinfectants have verified at least the following spectra of activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses
Observe the specifications of the surface disinfectant manufacturers.
Dräger states that oxygen-releasing agents and chlorine-releasing agents may cause color change in
some materials. Color change does not indicate that the product is not functioning correctly.
WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
Ensure that no liquid penetrates the device.
1 Remove soiling immediately. Use a cloth dampened with disinfectant to remove soiling.
2 Perform surface disinfection.
3 After the product has been exposed to the disinfectant for the specified contact time, remove residual
disinfectant.
4 Wipe with a cloth dampened with water (preferably drinking-water quality). Allow the product to dry.
5 Check the product for visible soiling. Repeat steps 1 to 5 if necessary.
6 Check the product for visible damage and replace if necessary.
CAUTION
Do not autoclave the Infinity PiCCO Pod.
Agents tested by Dräger and shown to have no harmful effect at the time of testing on the materials utilized
in the Infinity PiCCO Pod include:
– Isopropyl alcohol 40%
CAUTION
If using alcohol, it should only be a 40% diluted solution.
etCO2
Mainstream Module
To clean the Mainstream Module
1 Disconnect the sensor cable (SpO2 cable, if using) from the Dräger etCO2 mainstream module.
2 Wipe the module surfaces with a cloth moistened with a soap solution.
3 Dry thoroughly with a lint-free cloth.
To disinfect the Mainstream Module
1 Disconnect the sensor cable (including the SpO2 cable, if using) from the Dräger etCO2 Mainstream
Module.
2 Wipe the module surfaces with a gauze moistened with one of the following:
– A 1:3 solution of alcohol
– A 1:10 solution of sodium hypochlorite (household bleach)
3 Dry thoroughly with a lint-free cloth.
WARNING
To reduce the risk of infection, remember that the disposable cuvettes are for single patient use
only and cannot be sterilized.
1 Reattach the etCO2 module or pod to the monitor. The sidestream sampling pump starts running, and
there is suction at the input port on the face of the module or pod.
NOTE
If the sidestream pump fails to start, make sure the Capnostat sensor is disconnected. The pump is
designed to shut down while a connected sensor is warming up.
2 With the input sidestream port still open and the drain tubing still connected, let the pump run for
several minutes to remove any water still trapped in the system.
3 Block the sidestream input port with your finger for several seconds and then unblock it. Repeat at
least ten times.
4 Move your finger to the sidestream output port and block the port with your finger for several seconds
and then unblock it. Repeat at least ten times.
5 Remove the drain tubing, and allow the sidestream pump to continue running for at least 30 minutes.
NOTE
Sidestream accessories are for single use only. Do not reuse.
Technical Data
Electromagnetic Emissions
This equipment is intended for use in the electromagnetic environment specified below. The
user of this equipment should assure that is used in such an environment.
NOTE
When the monitor is configured with the wireless option, that option's radio emits electromagnetic
energy in order to communicate with the Infinity network. This may affect nearby equipment. See
the documentation that accompanies the wireless option's radio for further details.
CAUTION
Do not place monitor with radio operational next to paced patients.
Electromagnetic Immunity
This equipment is intended for use in the electromagnetic environment specified below. The
user of this equipment should assure that is used in such an environment.
Compliance
Immunity against IEC 60601-1-2 test level: level (of this Electromagnetic environment:
device:
Electrostatic Contact discharge: ±6 kV ±6 kV Floors should be wood, concrete
discharge, ESD air discharge: ±8 kV ±8 kV or ceramic tile. If floors are
(IEC 61000-4-2) covered with synthetic material,
the relative humidity should be at
least 30 % so that electrostatic
charges are at suitable levels.
Electrical fast Power supply lines: ±2 kV ±2 kV Mains power quality should be
transients / bursts longer input / output lines: that of a typical commercial or
(IEC 61000-4-4) ±1 kV ±1 kV hospital environment.
Surges on AC Common mode: ±2 kV ±2 kV Mains power quality should be
mains lines Differential mode: ±1 kV ±1 kV that of a typical commercial or
(IEC 61000-4-5) hospital environment.
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
magnetic field should be at levels characteristic
50/60 Hz of a typical location in a typical
(IEC 61000-4-8) commercial or hospital
environment.
Voltage dips and Dip >95%, 0.5 periods >95%, 0.5 per. Mains power quality should be
short interruptions Dip 60%, 5 periods 60%, 5 per. that of a typical commercial or
on AC mains input Dip 30%, 25 periods 30%, 25 per. hospital environment. If the
lines Dip >95%, 5 seconds >95%, 5 sec. monitor’s user requires continued
(IEC 61000-4-11) operation during power mains
interruptions, the monitor should
be powered from an
uninterruptible power supply or a
battery.
Electromagnetic environment guidance: Portable and mobile RF communications equipment
should be used no closer to any part of the monitor, including cables, than the recommended
separation distance calculated from the equation that applies to the frequency of the transmitter
listed below. In this equation, P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation distance in metres
(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1,
should be less than the compliance level in each frequency range2. Interference may occur in the
vicinity of equipment marked with the following symbol:
NOTE:
• For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
EMC declaration
General information
This device was tested for electromagnetic compatibility using accessories from the list of accessories.
Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use
of non-compliant accessories may result in increased electromagnetic emissions or decreased
electromagnetic immunity of the device.
This device may be used in the direct vicinity of other devices only if Dräger has approved this device
arrangement. If no approval has been given by Dräger, it must be ensured that this device functions
correctly in the desired arrangement before use. The instructions for use for the other devices must be
followed.
Electromagnetic environment
Emissions Compliance
Radiated emissions Kappa, Infinity Docking Station (IDS), integrated
MIB, SCIO Four Module, BISx pod:
– Class A, group 1 (30 MHz to 1 GHz)
Delta, Delta XL:
– Class B, group 1 (30 MHz to 1 GHz)
Conducted emissions Kappa, Infinity Docking Station (IDS), integrated
MIB, SCIO Four Module, BISx pod:
– Class A, group 1 (150 kHz to 30 MHz)
Delta, Delta XL:
– Class B, group 1 (150 kHz to 30 MHz)
NOTE
The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required), this equipment might not offer adequate protection to radio-frequency communication ser-
vices. The user might need to take mitigation measures, such as relocating or re-orienting the equip-
ment.
Voltage interruptions:
100 % drop, 5 seconds
Radiated high-frequency disturbances 80 MHz to 2.7 GHz: 3 V/m
(IEC 61000-4-3)
Conducted high-frequency disturbances 150 kHz to 80 MHz: 3 Vrms, ISM bands: 6 Vrms
(IEC 61000-4-6)
Electromagnetic fields in the vicinity of wireless Various frequencies from 385 MHz to 5785 MHz:
communication devices 9 V/m to 28 V/m, with various pulse modulations
To ensure that the functional integrity of this device is maintained, there must be a separation distance of
at least 1.0 m (3.3 ft) between this device and wireless communication devices.
System Components
NOTE
The Infinity alarm volume must be set at 20% or higher to
comply with the minimum audio sound pressure of 45 db
specified in standard 60601-2-49.
NOTE
Storage of the monitor at 40 °C (104 °F) for an extended period
of time (3 - 5 months) degrades the battery capacity.
Monitoring Accessories
Physical specifications
Mode of operation Continuous
Protection against electric Sensor: Type BF
shock
Defibrillator protection Yes
Environmental requirements
Temperature range Operating: 10 to 40 °C (50 to 104 °F)
Storage: –40 to 75 °C (–40 to 167 °F)
Relative humidity Operating: 20 to 90%, non-condensing
Storage: 10 to 95% (with packaging)
Atmospheric pressure Operating: 525 to 795 mmHg (70 to 106 kPa)
Storage: 86 to 825 mmHg (11.5 to 110 kPa)
Monitoring Specifications
WARNING
The following parameters and functions are not monitored in neonatal mode: Arrhythmia,
cardiac output, ST, pacer detection,% paced, and all MultiGas parameters.
ECG
Description Value
V/s pacer detected 3.18 V/s
Respiration
Description Value
Detection threshold: 0.15Ω to 4.0Ω in manual mode (user adjustment)
Adult and Pediatric: 0.20Ω - 1.5Ω in auto mode
(automatic adjustment)
Neonatal: 0.20Ω - 1.5Ω in auto mode
(automatic adjustment)
Measurement range: Range: 0 - 154 breaths per min
NOTE
For neonatal patients with high blood pressure and a heart rate close to 30 bpm, the monitor may not be
able to measure NBP within the maximum measurement time of 90 seconds.
Description Value
Intended use The Infinity Masimo SET® pod and accessories are
indicated for use during both motion and non-motion
conditions and for patients who are well or poorly
perfused.
Parameter display: Saturation (%SpO2), pulse rate, perfusion
Measurement range %SpO2: 1 to 100%
Pulse rate: 25 to 239 /min
Perfusion: 0.02 to 20%
Measurement accuracy(1, 5, 6):
The following are for all Masimo LNCS and LNOP sensors.
Saturation (%SpO2) - During conditions with no motion:(2)
0 to 69% not specified
70 to 100%:
Adults, pediatrics ±2
Neonates ±3
Saturation (%SpO2) - During motion conditions:(3,4)
0 to 69% not specified
70 to 100%:
Adults, pediatrics(3) ±3
Neonates(4) ±3
Pulse Rate (bpm) - During no motion conditions:(2)
Adults, pediatrics, neonates ±3
Pulse Rate (bpm) - During motion conditions:(3,4)
Adults, pediatrics, neonates ±5
NOTES:
1) Since pulse oximeter measurements are statistically distributed, only about two-thirds of those
measurements can be expected to fall within ±1 Arms of the value measured by a co-oximeter.
2) The Infinity Masimo SET SpO2 SmartPod pulse oximeter with LNOP-Adt sensors has been
validated for no motion accuracy in human blood studies on healthy adult volunteers in induced
hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This
variation equals ±1 Arms of the value measured by a co-oximeter.
3) The Masimo SET pod with LNOP-Adt sensors has been validated for motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and
tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to
5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 - 100% SpO2 against a
laboratory co-oximeter and ECG monitor. This variation equals ±1 Arms of the value measured by a
co-oximeter.
4) The Masimo SET pod with LNOP-Neo PT and Neo Pt sensors has been validated for motion and
no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies
while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-
repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the
range of 70 - 100% SpO2 against a laboratory co-oximeter and ECG monitor. 1% has been added to
the results to account for the effects of fetal hemoglobin.
5) The pulse rate accuracy has been validated on healthy adult volunteers during induced hypoxia
studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This
variation equals ±1 Arms of the pulse rate value measured by the ECG monitor.
6) A functional tester cannot be used to assess the accuracy of a Pulse oximeter probe or a Pulse
oximeter monitor.
Description Value
Intended use The Infinity Masimo SET® pod and accessories are
indicated for use during both motion and non-motion
conditions and for patients who are well or poorly
perfused.
Parameter display: Saturation (%SpO2), pulse rate, perfusion
Measurement range %SpO2: 1 to 100%
Pulse rate: 25 to 239 /min
Perfusion: 0.02 to 20%
Measurement accuracy:
The following are for all Masimo RD SET sensors.
Saturation (%SpO2) - During conditions with no motion:
0 to 69% not specified
70 to 100%:
Adults, pediatrics ±2
Neonates ±3
Saturation (%SpO2) - During motion conditions:
0 to 69% not specified
70 to 100%:
Adults, pediatrics ±3
Neonates ±3
Pulse Rate (bpm) - During no motion conditions:
Adults, pediatrics, neonates ±3
Pulse Rate (bpm) - During motion conditions:
Adults, pediatrics, neonates ±5
Pulse Rate :
(3)
±3 beats/min or ±3% (whichever is greater)
NOTES:
1) Since pulse oximeter measurements are statistically distributed, only about two-thirds of those
measurements can be expected to fall within ±1 Arms of the value measured by a co-oximeter.
2) The Infinity Nellcor Oximax™ SpO2 SmartPod™ pulse oximeter with adult sensors has been
validated in human blood studies on healthy adult volunteers in induced hypoxia studies in the range
of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1 Arms
of the value measured by a co-oximeter.
3) The pulse rate accuracy has been validated on healthy adult volunteers during induced hypoxia
studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This
variation equals ±1 Arms of the pulse rate value measured by the ECG monitor.
4) A functional tester cannot be used to assess the accuracy of a Pulse Oximeter Probe or a Pulse
Oximeter monitor.
Description Value
Rise time <35 ms
Delay time <165 ms
Time until availability <10 s
Data sample rate Sensor: 20 ms
Display update period 2s
Time until specified accuracy is attained <120 s (at 23 °C (73 °F))
Measurement accuracy drift Over 6 hours is <0.03 Vol% at 5 Vol% CO2
How performance is affected by The cuvette windows are indirectly heated through the
humidity/condensate sensor to prevent moisture condensation. Water droplets
and other window contamination may slightly influence
measurement bias, up to 0.3 Vol% at 5 Vol% CO2 at worst
(normally much less).
If measurement light is blocked so the noise of the reading
gets too high, an error message is displayed by the monitor
indicating that the cuvette must be checked (cleaned or
replaced).
How performance is affected by cyclical No effect
pressures up to 10 kPa (100 cmH2O)
Compensation Atm. Pressure: user-selectable; 540 to 800 mmHg (72-
106.7 kPa)
Gas Compensation: user-selectable; Air, N2O/O2,
O2>60%, HeliOx
NOTE regarding Gas Compensation:
Selection for Gas Compensation must be made for the
automatic correction of the influence of a balance gas.
NOTE
Regarding interfering gases and vapors:
These additional errors are not corrected for automatically through the Gas Compensation selection.
Output signals Graphical signal of the output voltage and current stimulation pulse:
A C
1
Stimulation current accuracy is ±5% within this range. Stimulation current is disabled at
impedance values greater than 8900 Ω.
2
At a stimulation current of 30 mA, voltage and current values are approximately half (50%) of
those listed for 60 mA.
NOTE
All Draeger approved pods and associated accessories that have patient contact are manufactured
without natural rubber latex, with the exception of the 7014616 temperature probe covers.
Some articles are not available worldwide because they are not approved in all countries.
ECG leads
Standard ECG lead sets (single pin version - for direct connection to MultiMed Plus and MultiMed Plus
OR).
MP03401 ECG 3-lead, grabber, 1m, single pin connector, IEC1 (European color code)
MP03402 ECG 3-lead, grabber, 1m, single pin connector, IEC2 (AHA color code)
MP03403 ECG 5-lead, grabber, 1/1.5m, single pin connector, IEC1 (European color code)
MP03404 ECG 5-lead, grabber, 1/1.5m, single pin connector, IEC2 (AHA color code)
MP03405 ECG 6-lead, grabber, 1/1.5m, single pin connector, IEC1 (European color code)
MP03406 ECG 6-lead, grabber, 1/1.5m, single pin connector, IEC2 (AHA color code)
Standard ECG Lead Sets (Dual Pin Version - for Direct Connection to MultiMed 5/6/12)
MP03411 ECG 3-lead, grabber, 1m, dual pin connector, IEC1 (European color code)
MP03412 ECG 3-lead, grabber, 1m, dual pin connector, IEC2 (AHA color code)
MP03413 ECG 5-lead, grabber, 1/1.5m, dual pin connector, IEC1 (European color code)
MP03414 ECG 5-lead, grabber, 1/1.5m, dual pin connector, IEC2 (AHA color code)
MP03415 ECG 6-lead, grabber, 1/1.5m, dual pin connector, IEC1 (European color code)
MP03416 ECG 6-lead, grabber, 1/1.5m, dual pin connector, IEC2 (AHA color code)
MP03417 ECG 5-lead C, grabber, 1m, dual pin connector, IEC1 (European color code)
MP03418 ECG 5-lead C, grabber, 1m, dual pin connector, IEC2 (AHA color code)
IBP accessories
5196998 Hemo pod adapter, Abbott/Medex/(Transtar) (One for each DualHemo and two for each
QuadHemo/HemoMed pod)
NOTE
For Masimo sensors, unique part numbers for USA and Japan apply.
NOTE
Always refer to the Directions for Use accompanying the Masimo patient accessories.
NOTE
LNCS intermediate cables are designed to last approximately 17,000 hours while actively monitoring
SpO2 (for example 4 years if monitoring occurs 12 hours a day). This duration is monitored by a chip
inside the cable.
PN Description
MS34677 Nellcor FLEXMAX Adt, SpO2 sensor, adult, finger
MS34678 Nellcor FLEXMAX Pdt, SpO2 sensor, pediatric, finger
*NOTE: Only for use with Nellcor Oximar technology.
Mainstream etCO2
PN Description
6871950 Dräger Infinity MCable - Mainstream CO2.
6870279 etCO2 cuvette adult, reusable (resistance 0.4 mbar at 60 L/min,
internal volume 7 mL) for CO2 sensors 6871500, 6870300, 6871950.
6870280 etCO2 cuvette pediatric, reusable (resistance 3.0 mbar at 30 L/min,
internal volume 5 mL), for CO2 sensors 6871500, 6870300, 6871950.
MP01062 etCO2 cuvette, adult, disposable (resistance 0.32 mbar at 60 L/min,
internal volume 7 mL), 10 pcs.
MP01063 etCO2 cuvette pediatrics, disposable (resistance 2.4 mbar at
30 L/min, internal volume 5 mL), 10 pcs.
PN Description
MS32282 Infinity kit:
1 Infinity PiCCO pod
2 Dräger 10-pin Transducer Adapter Cable
1 PULSION pressure transducer to PiCCO pod interface cable, 20 cm
1 PiCCO pod C.O. injectate thermistor cable
1 PiCCO pod C.O. catheter cable
1 PiCCO pod C.O. intermediate cable, 1.5 m
1 PodCom Cable to monitor (3 m)
1 Universal Pole Mount
NOTE: All disposables are delivered by PULSION directly.
MS23133 Infinity PiCCO pod
PN Description
MS22532 Dräger 10-pin Transducer Adapter Cable (Adapter cable to connect
PULSION disposable pressure transducers to the PiCCO Pod).
MS16920 PULSION pressure transducer to PiCCO Pod interface cable
(Connects PULSION disposable pressure transducers to the adapter
cable).
MS16919 PiCCO pod C.O. injectate thermistor cable (Connects the PiCCO
PV4046 injectate sensor housing to the C.O. intermediate cable).
MS16918 PiCCO pod C.O. catheter cable (Connects the PiCCO arterial
thermodilution catheter to the C.O. intermediate cable).
MS16916 PiCCO pod C.O. intermediate cable, 1.5 m (Connects the PiCCO
C.O. catheter cable and C.O. thermistor cable to PiCCO pod).
NOTE: All disposables are delivered by PULSION directly.
Troubleshooting
Admitting a Patient
Configuring the Menu Time Limit to OFF can obscure waveform data and other information while the
Patient Admit menu remains active. Under this configuration, due to the lack of a menu timeout, as soon
as the Patient Admit menu is no longer required, users should cancel the menu so that the monitor can
display all information of monitored parameters.
Discharging a Patient
When a patient is discharged from the Delta monitor and is placed on another Delta monitor, but the first
monitor is not placed on a new patient, the Gateway may see the patient on two monitors: the Delta
monitor that is in a discharge state and is not monitoring another patient, and the monitor that is currently
monitoring the patient. This scenario may cause data exchange issues if the Delta monitor is interfaced to
other information systems (e.g., electronic health record).
Alarms
Alarm Management
The monitor may not suppress disconnect-related messages without a validated clinical signal in
situations that reset the monitor (e.g., changing units of measure, restore setup, power cycling).
Acknowledging disconnect-related alarms (e.g., pressing Alarm Silence) removes these alarms.
Trends
Mini-Trends
When viewing Mini-Trend data and removing and re-connecting parameter cables (e.g., ECG MultiMed
cable), allow the monitor 10 seconds to update Mini-Trend data so that the trend data color matches that
of the monitored parameters.
Status Messages
If an ECG Leads Invalid alarm remains displayed even though ECG leads are connected and the alarm
has been acknowledged, disconnect and reconnect the ECG leads to clear the ECG Leads Invalid alarm.
Respiration
Cursor
In the OCRG screen, if inaccurate measurement values are suspected when a cursor rests on a point on
a waveform, allow the OCRG screen to populate data for a full 3 minutes if the configured time duration
is 3 minutes (or 6 minutes if the configured time duration is 6 minutes).
Time Base
If the OCRG time base is changed (e.g., from 6 minutes to 3 minutes), the OCRG cursor time may be one
minute ahead of the monitor's time. This issue is rectified upon patient discharge.
Recordings
If a timed recording is performed with OCRG so that an etCO2 or etCO2* waveform is printed, the
etCO2/etCO2* waveform appears as a flat line in the middle of the grid. All etCO2-related numeric values
are correct and available.
Precautions
NOTE
If a MultiGas parameter box appears after a Restore Setup with a Dräger mainstream CO2 module
connected to the monitor, do the following:
1 Disconnect the Dräger mainstream CO2 module.
2 Connect a Scio module.
3 Disconnect the Scio module.
4 Reconnect the Dräger Mainstream CO2 module.
This procedure should remove the MultiGas parameter box.
When performing a cardiac output calibration and the Manual CVP setting in the Pulse Contour setup
menu is set to enabled, ensure 4 minutes have passed after initiating the calibration before entering a CVP
value.
Overview
If OSI OpticalCAM blood gas monitor pH values are interfaced into the monitor through MIB, the trended
pH values are not available on the central station. This information is transferred over the network and
through Gateway and, therefore, does not impact interfaced information systems. This trended
information should be available directly from the blood gas analyzer or interfaced information systems.
MS32649 – RI 05 en
© Drägerwerk AG & Co. KGaA
Edition: 5 – 2020-03
(Edition: 1 – 2015-12)