Supplement
Infinity® Delta Series
WARNING Infinity® Patient Monitoring Series
To properly use this medical device,
read and comply with the instructions
Software VF9.1
for use and this supplement.
Contents
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Dräger Mainstream etCO2 Monitoring . . . . . . 24
For your safety and that of your patients . . . . . 6 Application . . . . . . . . . . . . . . . . . . . . . . . . . 24
Mandatory reporting of adverse events . . . 6 Precautions . . . . . . . . . . . . . . . . . . . . . . . . 24
General Supplement Notes . . . . . . . . . . . . . . . 6 Connection. . . . . . . . . . . . . . . . . . . . . . . . . 26
Definition of Target Groups . . . . . . . . . . . . . 6 Connecting the Sensor . . . . . . . . . . . . . . . 27
Device Symbols . . . . . . . . . . . . . . . . . . . . . . . . 7 Getting Started. . . . . . . . . . . . . . . . . . . . . . 28
Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Display Features . . . . . . . . . . . . . . . . . . . . 28
Main Menu Setup . . . . . . . . . . . . . . . . . . . . 7 Capnograms . . . . . . . . . . . . . . . . . . . . . . . 31
Unit Manager . . . . . . . . . . . . . . . . . . . . . . . 7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . 32
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Status Messages . . . . . . . . . . . . . . . . . . . . 35
General Requirements - Alarm Setup. . . . . 9 MultiGas Monitoring . . . . . . . . . . . . . . . . . . . . 35
Alarm History Table. . . . . . . . . . . . . . . . . . 11 SCIO MultiGas. . . . . . . . . . . . . . . . . . . . . . 35
Alarm Latching . . . . . . . . . . . . . . . . . . . . . . 11 Status Messages . . . . . . . . . . . . . . . . . . . . 37
ECG and Heart Rate . . . . . . . . . . . . . . . . . . . . 12 Neuromuscular Transmission (NMT)
ECG Setup Menu . . . . . . . . . . . . . . . . . . . . 12 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Arrhythmia Monitoring . . . . . . . . . . . . . . . . . . . 13 Precautions . . . . . . . . . . . . . . . . . . . . . . . . 38
Arrhythmia Ranges and Defaults . . . . . . . . 13 Pulse Contour Cardiac Output (PiCCO)
Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Non-Invasive Blood Pressure . . . . . . . . . . . . . . 15 Overview of the Infinity PiCCO Pod. . . . . . 38
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 15 To set up the PiCCO Pod. . . . . . . . . . . . . . 40
NBP Setup . . . . . . . . . . . . . . . . . . . . . . . . . 17 Cleaning and Disinfecting . . . . . . . . . . . . . . . . 42
Continuous Non-invasive Arterial Blood IBP - Infinity PiCCO Pod . . . . . . . . . . . . . . 42
Pressure (CNAP) Pod . . . . . . . . . . . . . . . . . . . 18 etCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
CNAP Calibration . . . . . . . . . . . . . . . . . . . . 19 Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . 44
Status Messages . . . . . . . . . . . . . . . . . . . . 19 Electromagnetic Compatibility (EMC) . . . . 44
Maintenance (CNAP) . . . . . . . . . . . . . . . . . . . . 19 System Components . . . . . . . . . . . . . . . . . 45
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Monitoring Accessories . . . . . . . . . . . . . . . 46
Definition of Maintenance Concepts . . . . . . 20 Monitoring Specifications . . . . . . . . . . . . . . 47
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Approved Options and Accessories . . . . . . . . 56
Visual Inspection. . . . . . . . . . . . . . . . . . . . . 21 Temperature probe covers. . . . . . . . . . . . . 56
Inspection/ Safety Check . . . . . . . . . . . . . . 21 ECG leads . . . . . . . . . . . . . . . . . . . . . . . . . 56
Metrological checks . . . . . . . . . . . . . . . . . . 22 Invasive Blood Pressure (IBP). . . . . . . . . . 57
Preventive Maintenance . . . . . . . . . . . . . . . 22 Pulse Oximeter (SpO2) . . . . . . . . . . . . . . . 57
Pulse Oximetry (SpO2). . . . . . . . . . . . . . . . . . . 22 Mainstream etCO2. . . . . . . . . . . . . . . . . . . 60
Quick Reference Table - SpO2 Setup . . . . 23 Infinity PiCCO Pod. . . . . . . . . . . . . . . . . . . 60
New Status Message . . . . . . . . . . . . . . . . . 24 Infinity PiCCO Pod Connecting Cables . . . 60
Supplement – Infinity® Delta Series VF9.1 3
This page has been left blank intentionally.
4 Supplement – Infinity® Delta Series VF9.1
Infinity® Delta Series Instructions for use All rights reserved
Software SW VF9.1 Some graphics courtesy of Covidien
©Drägerwerk AG & Co. KGaA, 2014. Unpublished rights reserved under the copyright
laws of the United States.
All rights reserved.
RESTRICTED RIGHTS LEGEND Use duplication
Printed in the United States of America.
or disclosure by the Government is subject to re-
Reproduction in any manner, in whole or in part, in strictions as set forth in subparagraph (c)(1)(ii) of
English or in any other languages, except for brief the Rights in Technical Data & Computer Software
excerpts in reviews and scientific papers, is prohib- clause at DFARS 252 227:7013
ited without prior written permission of Dräger.
The capnography component of this product is cov-
Before using any Dräger devices, carefully read all ered by one of the following US patents: 6,428,483;
the manuals that are provided with your device. Pa- 6,997,880; 6,437,316; 7,488,229; 7,726,954 and
tient monitoring equipment, however sophisticated, their foreign equivalents. Additional patent applica-
should never be used as a substitute for the human tions pending.
care, attention, and critical judgment that only
All other brand or product names are trademarks of
trained health care professionals can provide.
their respective owners.
ACE®, DrägerService®, MultiMed®, Hemo2®, He-
mo4®, Infinity®, SmartPod®, Trident®, Pick and
Go®, Scio®, MicrO2+®, and OxiSure® are trade-
marks of Dräger.
PiCCO®, PULSION®, and PULSIOCATH® are
trademarks of PULSION Medical Systems.
CAPNOSTAT® is a trademark of Philips
A-2000, BIS®, BISx®, Bispectral Index®, Microst-
ream®, and Nellcor® are trademarks of Covidien.
CNAP® is a trademark of CNSystems Medizintech-
nik AG.
Masimo®, Masimo SET® and Signal Extraction
Technology (SET)® are trademarks of Masimo
Corporation.
SILICON SOFTWARE © 1989, 90, 91, 92, 93, 94
Microtec Research Inc.
Supplement – Infinity® Delta Series VF9.1 5
For your safety and that of your patients
Mandatory reporting of adverse events
Serious adverse events with this product must be
reported to Dräger and the responsible authorities.
General Supplement Notes
WARNING Users
A WARNING statement provides important Users are persons who use the product in accor-
information about a potentially hazardous sit- dance with its intended use.
uation which, if not avoided, could result in
death or serious injury.
Service Personnel
CAUTION Service personnel are persons who are responsible
A CAUTION statement provides important infor- for the maintenance of the product. Service person-
mation about a potentially hazardous situation nel must be trained in the maintenance of medical
which, if not avoided, may result in minor or mod- devices and install, reprocess, and maintain the
erate injury to the user or patient, or in damage to product.
the equipment or other property.
Experts
NOTE
Experts are persons who perform repair or complex
A NOTE provides additional information intended
maintenance work on the product. Experts must
to avoid inconveniences during operation.
have the necessary knowledge and experience
with complex maintenance work on the product.
Definition of Target Groups
Training
For this product, users, service personnel, and ex- Training for users is available via the responsible
perts are defined as target groups. Dräger organization (see www.draeger.com).
These target groups must have received instruction
in the use of the product and must have the neces-
sary 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 tar-
get groups.
6 Supplement – Infinity® Delta Series VF9.1
Device Symbols
The following table describes new and revised symbols that appear on the monitor and its accessories:
Fragile, handle with care Warning! Strictly follow the instructions for use
in the instructional manual or booklet
Keep Dry Print the currently displayed screen to a net-
work laser printer
Medical Device Contains DEHP
Caution: This product con-
tains natural rubber latex
which may cause an allergic
reaction
Monitor Setup
Main Menu Setup
Date & Time is no longer a selection in the Main by qualified hospital technical personnel or Dräger
Menu > Monitor Setup > Monitor Options sub- Service personnel in the password-protected
menu. Date and time changes are only permitted Service menu.
Unit Manager
The Unit Manager menu lets supervisory person-
nel configure monitoring functions for the clinical
staff. Access to this menu is restricted by a pass-
word.
Supplement – Infinity® Delta Series VF9.1 7
Unit Manager Menu
Menu Item Description Available Settings
The Alarm Control 1 and Alarm Control 2 submenus:
This menu allows the Unit Manager to configure alarm annunciation. Open the Unit Manager menu,
click on Alarm Control 1 or Alarm Control 2, and then follow the procedures outlined in this table to
execute the indicated functions.
All Alarms OFF A reminder tone to indicate all alarms are – Enabled (default)
Reminder tone OFF permanently. – Disabled
(Alarm Control 1
Enabled when the All Alarms OFF
submenu)
feature is set to Enabled. A remind-
er tone sounds every 30 seconds at
50 % volume.
Audio OFF Re- Allows you to set a reminder when the Alarm – Enabled (default) - When the
minder (Alarm Volume feature is set to Disabled. alarm volume is set to Disabled,
Control 1 sub- a reminder tone sounds every
menu) 30 seconds at 50% volume.
For monitors in OR mode: At the
end of an alarm silence or an
alarm off period, if the alarm
condition is still active, the pa-
rameter box flashes and a re-
minder tone (high, medium, or
low) sounds every 30 seconds
at 50% volume.
– Disabled - There is no reminder
tone when alarm volume is set
to Disabled.
The CODE Setup submenu
This menu allows the unit manager to configure the monitor for quick emergency response. Open the
Unit Manager menu, click on CODE Setup, and then select and execute functions as described in this
table.
Audio OFF Allows you to lower the alarm volume to OFF – Yes - Temporarily sets the alarm
when you press the Code fixed key. volume and the minimum alarm
volume to OFF when you press
the Code key.
NOTE: The central station continues to – No (default) - The alarm volume
sound audio alarms after you press the and the minimum alarm volume
Code key. settings do not change when
you press the Code key (i.e. re-
tains prior settings).
8 Supplement – Infinity® Delta Series VF9.1
Alarms
General Requirements - Alarm Setup
Upper and Lower Alarm Limits
Alarm limits should be set according to your pa-
tient’s prevailing condition within the predefined
ranges of the monitor listed in the following table:
Parameter Predefined Alarm Range and Res- Default State Default Alarm Setting
olution
iCO2/iCO2* 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/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
Supplement – Infinity® Delta Series VF9.1 9
Auto Set Alarm Limits
Alarm Limits Table
Function Description Available Settings
Auto Set Sets alarm limits based on current values: Not applicable
Parameters Upper Limit Lower Limit
NOTE:
Ta, T1a, T1b, < 107% of cur- < 93% of cur- • The monitor recalculates the upper
T2a, T2b, T3a, rent value rent value and lower alarm limits based on the
T3b parameter values in the Current
column.
ΔT1, ΔT2, ΔT3, No change No change • Auto Set applies to all displayed
PVC/min, parameters and ST parameters
iCO2, iCO2* only.
• If a calculated limit value falls
SpO2/SpO2* Adults 100 Current value outside the range for that
- (value x 5%) parameter, the parameter’s alarm
Neonates 98 limits remain unchanged.
ΔSpO2% Current value + None
20%
ST Current value Current value
+2.0 mm -2.0 mm
MultiGas Agent < 105% of cur- < 95% of cur-
rent value rent value
BIS No change No change
TOF-Cnt No change No change
PCCO Current value + Current value -
30% 30%
PCCI Current value + Current value -
30% 30%
MultiGas O2 100% 21%
tp < 125% of cur- < 80% of cur-
rent value rent value
All others Current value + Current value -
25% 20%
10 Supplement – Infinity® Delta Series VF9.1
Alarm History Table
The monitor stores up to 50 physiological alarm MultiGas and Dräger Mainstream CO2 monitoring
events for each patient (the oldest log entry is over- (e.g., alarms relating to module disconnection). The
written). Events are deleted when the patient is dis- Alarm History table also records every activation
charged. Data is stored in the monitor and remains and deactivation of cardiac bypass mode, every
with the patient during Pick and Go transports. Data change of patient category, and records whenever
also survives power shutdowns. The Alarm Histo- you perform an All Alarms OFF/All Alarms
ry table records all high-priority and medium-priori- Paused or Audio Paused/Alarm Silence. Switch-
ty alarms as well as selected low-priority alarms for ing the device on and off is not recorded.
Alarm Latching
Some alarms are latched: they continue to annun- the alarm no longer exists. Other alarms may be
ciate visually and audibly until you acknowledge latched only partially, as indicated in the following
them manually, even if the condition that caused table:
NOTE
High-priority and medium-priority alarms do not
latch in OR mode.
Alarm Latching Behavior
High-priority alarms are latched (visual and auditory alarm signals continue).
Medium-priority alarms only latch the alarm message; it continues to display when the alarm condition
ceases, while the parameter box stops flashing and the alarm tone ceases.
Low-priority alarms cease as soon as the cause of the alarm disappears.
To acknowledge (or silence) a latched alarm,
press the Alarm Silence fixed key.
Supplement – Infinity® Delta Series VF9.1 11
ECG and Heart Rate
ECG Setup Menu
Menu selection Description Available Settings
The ECG Options submenu
This submenu allows you to configure the following functions:
Pacer Detection Determines the monitor’s ability to In basic mode:
identify pacemaker pulse. Allows user
– Select ON to enable pacemaker de-
to enable/disable pacer detection or
tection.
choose more advanced Fusion selec-
tion. – Select OFF (default) to disable pace-
maker detection.
CAUTION: Fusion mode pacer detec-
tion is not intended for use with large-
signal, unipolar pacemakers. It is in-
tended for use only with bipolar pace-
makers.
Pacer Detection Observe the following: In advanced mode:
(continued)
– Select Fusion mode only in situa- – Select ON to enable pacemaker de-
tions where it becomes necessary tection.
to suppress repeated false asystole
– Select OFF (default) to disable pace-
and/or false low heart rate alarms.
maker detection.
– Before selecting Fusion mode, be
– Select Fusion to enable pacer detec-
certain that the patient has a bipolar
tion, but minimize pacer tail rejection
pacemaker (external or implanted)
to reduce missed detection of pseudo-
and that it is accurately pro-
fused paced beats, which results in
grammed as appropriate for that
false asystole alarms.
patient.
– Do not use Fusion mode if you are
uncertain as to what type of pace-
maker is being used.
12 Supplement – Infinity® Delta Series VF9.1
Arrhythmia Monitoring
Arrhythmia Ranges and Defaults
Parameter Alarm Grade 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) In- 5 to 15 (10) Incre- Str./Rec.
crements of 10 ments 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) In- 3 to 10 (3) Incre- Str./Rec.
crements of 10 ments of 1
TACH MED 100 to 200 (130) In- 5 to 15 (8) Incre- OFF
crements of 10 ments of 1
BRDY MED 30 to 105 Not adjustable (8) OFF
(50)
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 heart rate alarm that is adjustable.
Supplement – Infinity® Delta Series VF9.1 13
Respiration
Quick Reference Table - OCRG Setup
OxyCRG Setup Menu
Menu item Description Settings
Parameter 2 Displays a list of label choices for updating the sec- – SpO2
ond channel of the OCRG menu. – tpO2
– tpO2*
Parameter 3 Displays a list of label choices for updating the third – RESP
channel of the OCRG menu. – etCO2
– etCO2*
Timed Displays Time Base choices. – 3min
– 6min
NOTE: Selecting Time Base displays the clinical
password menu. The new OCRG Time Base takes
effect after you enter the password.
Quick Reference Table - OxyCRG Review Summary
The OxyCRG Review Summary Menu
Menu item Description Settings
Hours Changes the time interval for data on the OCRG – 1 hr
Summary screen. Press knob to select the Hours button. – 2 hr
Turn the rotary knob to select the time interval setting. – 4 hr
Press the rotary knob again to display a new time interval. – 6 hr
– 12 hr
14 Supplement – Infinity® Delta Series VF9.1
Non-Invasive Blood Pressure
Overview
The monitor can acquire and process non-invasive The accuracy is compromised with patients having
blood pressure (NBP) signals and display the dysrhythmias, arterial sclerosis, experiencing
results for neonatal, pediatric and adult patients. seizures, or any type of cardiac or vascular
NBP accuracy was established using intra-arterial malformation which results in an abnormal arterial
blood pressure monitoring as a reference (within waveform. Blood pressure measurements are
the limits prescribed by the Association for determined by the oscillometric method. Once the
Advancement of Medical Instrumentation, cuff has been inflated to occlude the blood flow
Electronic Automated Sphygmomanometers). through the patient’s limb, the cuff is deflated in a
Accuracy testing references used the femoral controlled manner. As the cuff pressure decreases,
artery for adults, and the umbilical, brachial, radial the oscillations increase in amplitude and then
or femoral arteries for pediatric and neonate decrease as blood returns to normal flow. From this
patients. NBP measurements for accuracy testing change in amplitude the mean arterial blood
occurred on the same limb. NBP effectiveness for pressure can be directly determined and systolic
pregnant and pre-eclamptic patients has not been (S) and diastolic (D) blood pressures derived.
established according to ISO 81060-2.
Supplement – Infinity® Delta Series VF9.1 15
NBP Cuff Diagram
A B C
E D
A Cuff size indicators D Range labels
B Artery label E Label: This side to patient
C Index line
NOTE
This illustration provides a general description
that can be applied to all cuffs. For additional in-
formation, see the instructions for use included
with your NBP cuff, as applicable.
16 Supplement – Infinity® Delta Series VF9.1
NBP Setup
To connect the hose
Push the hose end fitted with the plastic collar
firmly into the connector on the left side of the
monitor (see figure below).
NBP hose connector
NBP hose connector
Kappa
Delta/Delta XL
Venous Stasis
Software VF9.1 and higher supports venous stasis
in adult mode only (with adult-based inflation pres-
sures).
Supplement – Infinity® Delta Series VF9.1 17
Continuous Non-invasive Arterial Blood Pressure (CNAP) Pod
A
C
E
G B
A Cuff controller with sliding mount E CNAP pod
B Cuff controller cable F Aux/Hemo or PodCom connector
C Forearm strap G PodCom cable
D Sensor cuff
To connect CNAP pod and sensor cuff NOTE
1 Connect the sensor cuff (D) to the cuff controller During CNAP measurements, the NBP Interval
(A). Time (5, 10, 15 min) is disabled and controlled by
the Auto CNAP Relearn menu.
2 Connect the cuff controller cable (B) to the Cuff-
Controller (A).
3 Connect the cuff controller cable (B) to the
CNAP (E).
4 Connect the CNAP pod (E) to the monitor’s
Aux/Hemo or PodCom connector (F) via the
PodCom cable (G).
18 Supplement – Infinity® Delta Series VF9.1
CNAP Calibration
Each time a CNAP measurement starts or the infla- and the CNAP values are blank. After a successful
tion pressure alternates between the dual finger NBP measurement, the CNAP waveform and
cuffs, CNAP automatically calibrates. Calibration CNAP values display.
consists of a pulse determination phase followed by
an NBP correlation measurement. During calibra- NOTE
tion a triangular wave (for pod firmware version A “rectangular” or “square” waveform displays for
2.14.14.) displays in the CNAP waveform area and previous firmware versions.
then the message CNAP @ Calibrating displays
Status Messages
Message Cause Remedy
CNAP @ Calibrat- CNAP calibration is in progress. Wait until calibration is complete.
ing
NOTE
Calibration could take up to 2.5 minutes. De-
pending on the pod firmware version, a trian-
gular waveform or intermittent ascending/de-
scending angled lines (pod firmware version
2.14.14) are displayed when calibration is in
progress. Since 15 minutes is the maximum
time between recalibrations and includes this
2.5 minutes, the actual useful duration for
CNAP monitoring is 12.5 minutes. This rep-
resents an 83 % duty cycle.
Maintenance (CNAP)
Overview WARNING
Risk of infection.
This chapter describes the maintenance measures
required to maintain the proper functioning of the Users and service personnel can become in-
medical device. Maintenance measures must be fected with pathogenic germs.
performed by the responsible personnel. Disinfect and clean the device or the device
parts before any maintenance measures and
also before returning the medical device for
repair.
Supplement – Infinity® Delta Series VF9.1 19
WARNING CAUTION
Risk of electric shock This device must be inspected and serviced at
regular intervals. A record must be kept on this
Components that carry current are located un-
preventive maintenance. We recommend obtain-
der the cover. Do not remove the cover. Main-
ing a service contract with DrägerService through
tenance measures must be performed by the
your vendor. For repairs we recommend that your
responsible personnel. Dräger recommends
contact DrägerService.
DrägerService to perform these measures.
CAUTION
WARNING
When servicing devices from Dräger, always use
If the device is mechanically damaged, or if it
replacement parts that are qualified to Dräger
is not working properly, do not use it. Contact
standards. Dräger does not warrant or ensure the
your hospital's technical personnel. Never
safe performance of third-party replacement parts
perform monitor service or maintenance activ-
for use with the devices.
ities while actively monitoring a patient.
CAUTION
If you spill liquid on the equipment, battery or ac-
cessories or immerse these components in liquid,
allow them to dry completely for at least 24 hours
to 48 hours. Contact your hospital's technical per-
sonnel to test whether any such component is ful-
ly operational before putting it back in clinical use.
Definition of Maintenance Concepts
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.
Preventative Recurrent specified measures intended to maintain the functional condition of a
Maintenance medical device.
Repair Measures intended to restore the functional condition of a medical device after a
device malfunction.
20 Supplement – Infinity® Delta Series VF9.1
Inspection
Perform inspections at regular intervals and ob-
serve the following specifications.
CNAP / Cuff Controller
Checks Interval Responsible personnel
Inspection/safety checks Every 2 years Service personnel
Metrological checks Every 2 years Service personnel
Visual Inspection WARNING
Risk of medical device failure.
Perform a visual inspection before every use and in
accordance with your hospital's policy. If safety checks are not performed on a regu-
lar basis, the proper operation of the medical
1 Make sure that the housing is not cracked or
device can be compromised. Perform Safety
broken and there are no signs of spilled liquids
Checks at the indicated interval.
or damage.
2 Inspect all accessories (for example, sensors 1 Check accompanying documents:
and cables). Do not use if there are any signs of – Instructions for use are available
damage.
2 Perform a functional test of the following fea-
3 Examine all system cables, power plugs and tures according to the instructions for use:
discontinue use if there are any signs of dam-
age. – CNAP pod
4 Inspect all patient cables, leads and strain re- – Cuff Controller
liefs for general condition. Make sure the con- – Perform device checks (for example calibra-
nectors are properly engaged at each end. tion of pod with cuff controller, sensor cuff,
and NBP cuff)
Inspection/ Safety Check – Check/Visual inspection
3 Check that the device combination is in good
Inspection and safety checks of devices must be condition:
performed according to suggested intervals.
– All labels are complete and legible
Scope of inspection/safety checks for the – There is no visible damage
CNAP Pod/ Cuff Controller 4 Use the instructions for use to check that all
Safety checks are no substitute for preventive components and accessories needed to use the
maintenance measures (including preventive re- product are available.
placement of wear parts} as identified by the man- 5 Check the electrical safety requirements ac-
ufacturer. Perform safety checks at the indicated in- cording to IEC62353.
tervals.
Supplement – Infinity® Delta Series VF9.1 21
Metrological checks Preventive Maintenance
If required by applicable regulations, the following WARNING
measurement functions must be checked every two
Risk of faulty components.
years by qualified DrägerService personnel:
Device failure is possible due to wear or mate-
– Body temperature
rial fatigue of the components. To maintain
– Non-invasive blood pressure proper operation of all components, this de-
vice must undergo inspection and preventive
maintenance at specified intervals.
WARNING
Risk of electric shock.
Before performing any maintenance work, dis-
connect all electrical connectors from the
power supply.
The following table shows the preventive mainte-
nance intervals:
Component Interval Measure Responsible Personnel
Calibration of CNAP Every 2 years Calibrate Expert
SmartPod
Calibration of CNAP cuff Every 2 years Calibrate Expert
controller
Replacement of the air Every 2 years Replace Expert
pump
Pulse Oximetry (SpO2)
WARNING WARNING
A pulse oximeter should be considered an Risk of patient injury.
early warning device. If a trend towards pa- If the SpO2 sensor is used in the presence of
tient hypoxemia is observed, blood samples significant concentrations of dyshemoglo-
should be analyzed by laboratory instruments bins, such as carboxyhemoglobin or methe-
to completely understand the condition of the moglobin, measurement accuracy may be re-
patient. duced.
Do not rely on measurement data if the SpO2
WARNING sensor is used under these conditions.
The pulsations from intra-aortic balloon sup-
port can elevate the pulse rate. Verify the
pulse rate of the patient against the heart rate.
22 Supplement – Infinity® Delta Series VF9.1
WARNING WARNING
If the SpO2 sensor is used in the presence of To reduce the hazard of burns during surgery,
elevated levels of bilirubin, measurement ac- keep the sensor or transducer and their asso-
curacy may be reduced. ciated cables away from the surgical site, the
electro-surgical unit return cathode, and the
Do not rely on measurement data if the SpO2
earth ground.
sensor is used under these conditions.
CAUTION
WARNING
For Masimo SET pod, after connection of the sen-
If the SpO2 sensor is used in the presence of
sor, observe monitor for any messages if the sen-
intravascular dyes, such as methylene blue,
sor does not light up. If the sensor LED does not
measurement accuracy may be inaccurate.
light up, replace sensor and/or intermediate ca-
Do not rely on measurement data if the SpO2
ble.
sensor is used under these conditions.
CAUTION
WARNING
Refer to the “Pulse Oximetry (SpO2)” chapter in
Risk of inaccurate data.
the Infinity Delta Series Instructions for Use for
In the presence of shock, low blood pressure,
Software VF9 for additional precautions regarding
severe vasoconstriction, major anemia, hypo-
safe device operation.
thermia, arterial occlusion proximal to the
sensor, and asystole, the pulse rate may be in-
accurate. CAUTION
Do not immerse the sensor or patient cable in any
WARNING liquid. Moisture may present a safety risk.
Risk of patient injury.
High intrathoracic pressure, pressure on the NOTE
thorax and other consecutive impairments of When in neonatal mode or pediatric mode with
the venous flow can lead to venous pulsation Basic Arrhythmia monitoring, bradycardia is a
and pulse signal failure. high heart rate alarm that is adjustable.
Do not position the SpO2 sensor where it
might be affected in this way.
Quick Reference Table - SpO2 Setup
Menu item Description Settings
SpO2 Alarm Accesses SpO2 alarms – SpO2 OxiSure = 20 – 100% in increments of 1%
on the Alarm Limits table. – Pulse OxiSure = 30 – 240% in increments of 5%
– SpO2 Masimo = 20 – 100% in increments of 1%
– Pulse Masimo = 30 – 240% in increments of 5%
– SpO2 Nellcor = 20 – 100% in increments of 1%
– Pulse Nellcor = 30 – 240% in increments of 5%
Supplement – Infinity® Delta Series VF9.1 23
New Status Message
The following status message applies to any moni-
tor using a Masimo SET pod.
Message Possible Cause Suggested Action
Replace SpO2 Sensor/Cable The sensor or the cable is ex- Replace the sensor or the cable.
pired or defective.
Dräger Mainstream etCO2 Monitoring
Application Precautions
Intended Use WARNING
Risk of misinterpretation
The Dräger Mainstream CO2 module, when con-
Misdiagnosis or misinterpretation of the mea-
nected to a monitor, allows the monitor to measure
sured values or other parameters can endan-
and display mainstream etCO2 (end-tidal CO2),
ger the patient. Do not make therapeutic deci-
iCO2 (inspired CO2) and RRc (Respiration Rate)
sions based solely on individual measured
for neonate, pediatric and adult patients. Respirato-
values and monitoring parameters. Therapeu-
ry phases are determined from excursion of the
tic decisions must be made solely by qualified
CO2 data through a threshold which is adaptively
users.
calculated from the CO2 curve. The maximum CO2
value during the expiratory phase is taken as end-
tidal CO2 (etCO2), immediately shown after each WARNING
breath. The Dräger Mainstream CO2 module can- Risk of patient safety
not be used simultaneously with Scio Four mod- The etCO2 related information displayed is in-
ules. tended to be used by trained and authorized
health care professionals only.
WARNING
For premature infants, do not carry out CO2 WARNING
measurements because the CO2 cuvette sig- Risk of inaccurate gas measurement values
nificantly increases the dead space.
During warm-up, reported values may not be
NOTE accurate. Wait until the Dräger Mainstream
CO2 sensor has completed initialization and
The Dräger Mainstream CO2 module is compati-
warm-up.
ble with Delta and Delta XL monitors. The Dräger
Mainstream CO2 module is not compatible with
Kappa. WARNING
The etCO2*, iCO2*, and RRc* alarms do not ac-
tivate until the second breath is detected after
turning on the monitor or discharging a pa-
tient.
24 Supplement – Infinity® Delta Series VF9.1
WARNING WARNING
RRc apnea alarms are NOT reported if the set- Do not use any explosive anesthetic agents,
ting RRc Apnea Time is set to OFF in the e.g., ether, or cyclopropane. Fire hazard!
etCO2 setup menu and the RRc* alarm feature
is deactivated. To generate RRc* apnea CAUTION
alarms, activate the RRc* alarms and select an
Leaks in the breathing circuit (for example, an un-
RRc* apnea time.
cuffed endotracheal tube or a damaged cuvette)
may significantly affect CO2* measurement val-
WARNING ues.
To minimize the risk of patient strangulation,
carefully position and secure sensor cables. CAUTION
To avoid accidental disconnections, do not apply
WARNING excessive tension to any sensor cable.
Patient monitors that measure CO2, anesthet-
ic agents, and/or respiratory mechanics are CAUTION
not intended to be used as an apnea monitor
To prevent leakage, make sure the cuvette is firm-
and/or recording device. While these products
ly connected to the breathing circuit.
provide an apnea alarm, that alarm condition
is initiated based on the elapsed time since
the last breath was detected. Clinical diagno- CAUTION
sis of a true apneic event, however, requires Check the CO2 mainstream sensor and measure-
multiple physiological signals. ing cuvette for damage before use. A damaged
CO2 sensor may impair electrical isolation or may
WARNING introduce debris into the breathing circuit.
In an ambient temperature of 104 degrees F
(40 degrees C), the CO2 mainstream sensor CAUTION
reaches a surface temperature of 110 degrees Only use the mainstream CO2 sensor with the ap-
F (43 degrees C). proved CO2 measuring cuvettes for adult or pedi-
atric applications. See the “Approved options and
WARNING accessories” section. The measuring function
may otherwise be inaccurate.
Do not use the CO2 mainstream sensor in an
explosive or oxygen-enriched environment
(atmosphere) (100% oxygen is allowed in the NOTE
measuring cuvette). Fire hazard! In this chapter, all Infinity Delta Series patient
monitors are referred to as "patient monitor".
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
reasonance imagers (MRI, NMR, NMI).
Supplement – Infinity® Delta Series VF9.1 25
Connection
Hardware - Module Connection
Connection ports are marked on the front of the Slide the Dräger mainstream CO2 module into the
Dräger mainstream CO2 module. Use the diagram slot on the rear of the monitor until it rests securely.
below as a guide when connecting the module, ca-
bles, and accessories to the monitor.
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 mod-
ule to monitor
26 Supplement – Infinity® Delta Series VF9.1
Connecting the Sensor
Before you connect any CO2 hardware, make sure CAUTION
the cuvette setting of the monitor matches the cu-
The cuvette windows of the reusable cuvette have
vette in use. For example, the Delta must be config-
different optical properties to the cuvette windows
ured for a disposable cuvette if a disposable cu-
of the disposable cuvette. Therefore, select the
vette is being used. Not aligning the configuration
cuvette type correctly. Otherwise the zero point
setting with the cuvette type compromises the dis-
shifts by up to 8 mmHg CO2 (1.1 kPa CO2).
played CO2 value.
I G
F Dräger mainstream CO2 sensor H Cuvette
G Y-piece I Tracheal tube adapter
To connect the sensor 4 Snap the Dräger mainstream CO2 sensor (F)
firmly into the cuvette (H) and make sure that
1 Connect the Dräger mainstream CO2 sensor
the cable is directed away from the patient.
cable into the Dräger mainstream CO2 module
input port (as depicted by B on the hardware – CAUTION
module connection diagram).
Always use the mainstream CO2 measuring cu-
2 Select a suitable mainstream cuvette (H) whose vettes with the windows in an upright position.
windows are clean and dry (replace the cuvette Otherwise condensation deposits from the
if necessary). breathing system may collect, which could impair
3 Insert the cuvette (H) between the endotracheal proper function.
tube adapter (I) and the ventilator (G).
Supplement – Infinity® Delta Series VF9.1 27
Getting Started
Patient Preparation for Dräger Mainstream CO2 Initialization
Monitoring
Upon start-up, the sensor goes through a warm-up
The following tips provide optimal monitoring re- period (status message \211 CO2* Warming Up
sults but must never replace hospital-approved appears). During this time (approximately 30 sec-
practices or manufacturer’s recommendations. onds), concentrations for CO2 may not be avail-
able.
A default O2 concentration of 21% (the percentage
of oxygen in ambient air) for all CO2 measurements
is assumed. If the patient is receiving supplemental
oxygen or N2O or HeliOx, select the gas that is be- Display Features
ing administered in the etCO2 parameter menu.
Make sure to adjust the atmospheric pressure to etCO2* Monitoring
the actual value. Failure to compensate for supple-
mental gases results in inaccurate measurement The etCO2* waveform displays the instantaneous
values. CO2 concentration. The etCO2* parameter box dis-
plays the following parameters:
When switching cuvette types (from reusable to
disposable or adult to pediatric, or vice versa) you – End-tidal CO2 (etCO2*) — The level of CO2
do not have to rezero a Dräger sensor. If the sensor in the airway at the end of expiration.
window is clean and the correct sensor type is cho- – Inspired CO2 (iCO2*) — The level of CO2 in
sen in the etCO2* parameter menu (under Cuvette the airway during the inspiration phase.
Type), only zero a Dräger sensor when the mea-
surement value is suspect. Otherwise, perform ze- – Respiration Rate (RRc*) — The patient’s
roing once a day or when prompted to rezero. respiration rate, derived from the etCO2*
signal by calculating an average rate over
CAUTION the two most recent breaths.
The cuvette windows of the reusable cuvette have NOTE
different optical properties to the cuvette windows
The parameter labels etCO2, iCO2, and RRc are
of the disposable cuvette. Therefore, select the
marked by an asterisk (*) to distinguish them from
cuvette type correctly, otherwise the zero point
CO2-related parameters provided by the Infinity
shifts by up to 8 mmHg CO2.
etCO2 Microstream SmartPod.
28 Supplement – Infinity® Delta Series VF9.1
etCO2* Parameter Box NOTE
Typical etCO2* parameter box displays are shown If alarms are disabled, crossed-out triangle icons
below. appear next to the corresponding parameter val-
ues.
A
NOTE
B
The patient monitor does not alarm for etCO2* vi-
olations until it has established a valid respiratory
E C rate.
D etCO2* Setup
F To access the etCO2* setup menu
Click on the etCO2* parameter box
A etCO2* (end-tidal CO2) label and value or
B etCO2* alarm limits 1 Press the Menu fixed key.
C iCO2* (inspired CO2) label and value 2 Click on Patient Setup.
D iCO2* alarm limit (upper limit only) 3 Click on Parameters to display a list of avail-
E Respiration rate label and value able parameters.
4 Click on etCO2*.
F Respiration rate alarm limits
Quick Reference Table - etCO2* Setup
Click on the following items to execute etCO2* set-
up functions:
Menu Item Description Settings
Device Describes what CO2* device is connected and – CO2*
displays parameters on the monitor. – SCIO/MIB
– None
NOTE
– If no CO2* device is connected, “None” dis-
plays (read-only).
– If one CO2* device is connected to the mon-
itor, the setting automatically displays the ap-
propriate device (read-only).
– If two CO2* devices are connected, the set-
tings are made available to the user to select
the desired CO2* device.
(See also the "Multiple CO2* Devices" section.)
Supplement – Infinity® Delta Series VF9.1 29
Menu Item Description Settings
Scale Sets the etCO2* waveform scale. 40, 60, 80, 100 mmHg (40 mmHg
default)
5, 8, 12, 16 kPa (5 kPa default)
5, 8, 12, 16% (5% default)
Resp. Sweep Sets the respiratory waveform sweep speed on 6.25, 12.5, 25, 50 mm/s (6.25
Speed the screen’s display. mm/s default)
Atm. Pressure Sets the compensation for ambient atmospheric 540-800 mmHg in increments of 1
pressure. mmHg (760 mmHg default)
72.0-106.7 kPa in increments of
0.1 kPa (101.3 kPa default)
Cuvette Type Sets the cuvette type for adult and pediatric – Disposable
adapters – Reusable (default)
Gas Compensa- Determines gas percentages for inspiratory and – Air (default)
tion expiratory breathing. – N2O/O2 (in OR mode only)
– O2>60%
– HeliOx
RRc* Apnea Sets the time that the monitor waits before re- OFF, 10, 15, 20, 25, 30 s
Time porting a cessation of breathing as an apnea (Adult: OFF default)
event. (Pediatric/neonatal: 15 s default)
Apnea Archive Stores and/or records an alarm event automati- OFF, Record, Store (default),
cally for apnea. You can later review stored Str./Rec.
alarms on the Event Recall screen.
Calibration Checks the calibration of the CO2* sensor with a test filter. The monitor will report
Check whether or not the calibration check has passed or failed.
NOTE
The sensor must be removed from the cuvette and zeroed before performing a cali-
bration check. During the calibration check the sensor must be connected to the test
filter.
CO2* Zero Zeroes the CO2* sensor. The CO2* sensor stores a new zero point for CO2* mea-
surements.
(Only available if
a Dräger Main- NOTE
stream CO2 mod- The sensor must be removed from the cuvette before zeroing. The sensor is zeroed
ule is connected.) in room air. Do not breathe on the cuvette during zeroing.
etCO2 Alarm Accesses etCO2* alarms in Alarm Limits table
WARNING
etCO2* alarms do not activate until the second breath is detected after turning
on the monitor or discharging a patient.
30 Supplement – Infinity® Delta Series VF9.1
Smart Apnea
In OR mode only, the monitor will automatically en- other than OFF in the etCO2* parameter menu.The
gage the Smart Apnea feature for RRc* apnea Smart Alarm feature will escalate an apnea alarm in
alarms if RRc* Apnea Time is set to a selection 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 sec- Capnograms
onds and if an apnea alarm condition is present for
10 seconds, an attention tone annunciates and the The monitor also displays an instantaneous CO2
alarm message RRc* @ Apnea displays. If the ap- waveform or capnogram.
nea alarm condition continues to be present for 20 NOTE
seconds, another attention tone will annunciate and If the monitor detects multiple CO2* devices, the
the alarm message remains on the monitor. At 30 first device that was connected to the monitor re-
seconds, a medium alarm will annunciate. At 60 tains priority until the user selects a different CO2*
seconds a high alarm will annunciate. device in the etCO2* parameter menu or the un-
desired CO2* is physically disconnected from the
Multiple CO2* Devices monitor.
NOTE
CO2* devices include the Dräger mainstream A
CO2 module, Scio Four modules, or a device with B
etCO2* capabilities (e.g., ventilator, anesthesia
machine) connected through MIB. C
The message Duplicate Device Connected ap-
pears when multiple CO2* devices are connected
to the monitor (for example, a Dräger mainstream
CO2 module and a Scio Four module that is con-
nected to the IDS). In addition to the message, the
D
etCO2* parameter menu appears. You can select
the desired CO2* device (as described in the Quick
E
Reference Table). Or, you can physically discon-
nect the undesired CO2* device. A Expiratory or alveolar plateau (level of
A label in the upper left corner of the etCO2* wave- CO2 in lungs ceases to increase signifi-
cantly)
form identifies the CO2* device that is providing in-
formation to the user. B End-tidal concentration point (end of expi-
ration phase, where CO2 is measured)
C Onset of inspiration phase
D Onset of expiratory phase
E Baseline during inspiration
Supplement – Infinity® Delta Series VF9.1 31
Zeroing
Perform the zeroing process once a day or Starting the Calibration Check of the Dräger
when prompted to zero. Mainstream CO2 Sensor with Test Filter
The zeroing operation is performed in ambient air 1 Remove the sensor from the cuvette and con-
with a clean Dräger mainstream CO2 sensor that is nect it to the test filter on the sensor cable.
removed from the cuvette.
2 Access the etCO2* parameter menu.
1 Remove the Dräger mainstream CO2 sensor
3 Select Calibration Check.
from the cuvette.
The monitor starts the check and displays the
2 Select CO2* Zero under the etCO2* parameter progress and result of the check in the message
menu. The monitor performs the zeroing opera- area.
tion and displays a message that the CO2 zero-
ing is in progress. Waveforms flatline and pa-
If the check was successful
rameter box values blank from the screen
during this cycle. The monitor displays the message, Filter Check
Successful. The test value is within the permissi-
3 Fit the Dräger mainstream CO2 sensor onto the
ble tolerance.
cuvette.
Fit the Dräger mainstream CO2 sensor back on
If zero was successful, the monitor will display the
the cuvette.
message CO2* Zero Accepted after approximate-
ly 30 seconds. If zero was unsuccessful, the moni- If the check was not successful
tor will display the message CO2* Zero Failed. Re-
The monitor displays the message, Filter Check
peat the zeroing operation. If the zero remains un-
Failed. The test value is outside the permissible tol-
successful, check whether the sensor is contami-
erance.
nated, clean it if necessary, and re-zero. If the zero
still remains unsuccessful, the sensor may be de- Contact DrägerService.
fective requiring replacement.
Checking Calibration of the Dräger Mainstream
Troubleshooting
CO2 Sensor with Test Filter
If an alarm occurs, the table below helps to quickly
Perform the calibration check of the Dräger identify causes and remedies. The possible causes
mainstream CO2 sensor with test filter at inter- and remedial measures should be consulted in the
vals of one month. order in which they are listed until the alarm is re-
solved.
Before the check
Prerequisite: The monitor is switched on and at
least the warm-up phase for the CO2 sensor has
elapsed.
Perform CO2 zero in ambient air.
32 Supplement – Infinity® Delta Series VF9.1
The following table lists the alarm messages in or-
der of priority.
Alarm Priority Alarm Cause Remedy
Medium iCO2* > # Leakage in the breathing Exchange breathing sys-
system. tem.
lnspired CO2 concentration has Check ventilation.
exceeded the upper alarm limit.
Gas measurement is inaccurate Adjust alarm limits if
due to high respiratory rate. necessary.
Large dead space. Check ventilation settings.
Medium etCO2* > # End-tidal CO2 concentration Check ventilation.
has exceeded the upper alarm
limit.
Medium etCO2* < # End-tidal CO2 concentration Check ventilation.
has fallen below the lower
alarm limit.
Medium RRc* > # The patient is breathing at a • Check patient condition.
high respiratory rate. • Check ventilation
settings or spontaneous
respiratory rate.
RRc* has exceeded the upper Check ventilation settings.
alarm limit.
Medium RRc* < # RRc* has fallen below the lower • Check patient condition.
alarm limit. • Check ventilation
settings.
Medium RRc* @ Apnea No breathing or ventilation. • Start manual ventilation!
(escalates in • Check ventilation
OR mode - see settings.
Smart Apnea
section) • Check spontaneous
breathing ability of the
patient.
Sample line is not connected. Connect sample line to
breathing circuit or gas
analyzer.
Medium iCO2* @ Out Of Inspiratory gas concentration Check ventilation.
Range (High) has exceeded the upper
measuring range.
Medium iCO2* @ Out of Range Inspiratory gas concentration Check zero.
(Low) has fallen below the lower
measurement range.
Medium etCO2* @ Out Of Expiratory gas concentration Check ventilation.
Range (High) has exceeded the upper
measuring range.
Supplement – Infinity® Delta Series VF9.1 33
Alarm Priority Alarm Cause Remedy
Medium etCO2* @ Out of Expiratory gas concentration • Check ventilation.
Range (Low) has fallen below the lower • Check zero.
measuring range.
Medium RRc* @ Out Of Range Respiration rate has exceeded Check ventilation or
(High) the upper measuring range. spontaneous respiration
rate.
Medium CO2* Check Cuvette A disposable cuvette has been Ensure the correct cuvette
Type selected on the monitor but a is used and that the
reusable cuvette has been cuvette selected on the
inserted into the breathing monitor is correct.
apparatus (or vice versa).
If cuvette used matches that Check zero.
selected on the monitor, the
zero may have drifted.
Medium CO2* Window Window is contaminated or Ensure window is clean.
Occluded occluded
Low CO2* Sensor Too Dräger mainstream CO2 sensor • Correct ambient clinical
Warm too warm as a result of the environment.
ambient clinical environment. • If the problem persists,
call DrägerService.
Low CO2* Disconnected Dräger mainstream CO2 sensor • Check sensor and
unplugged and/or module module connections.
disconnected. • If the problem persists,
call DrägerService.
Low CO2* H/W Failure Loss of communication. • Check cable
connections.
• Unplug and re-plug the
Dräger mainstream CO2.
• Power-cycle or undock
and re-dock the patient
monitor.
• If the problem persists,
call DrägerService.
Failure of the entire Dräger Call DrägerService.
mainstream CO2 module.
34 Supplement – Infinity® Delta Series VF9.1
Status Messages
Message Condition Suggested action
CO2* Please Zero Zero has drifted Perform a zeroing operation
CO2* Reduced Ac- Measurement values have reduced accu- • Wait until the warm-up phase has
curacy racy due to warm-up or because the ended before relying on the
Dräger mainstream CO2 sensor is begin- displayed etCO2* values for
clinical evaluation.
ning to become too warm.
• Correct ambient clinical
NOTE environment.
Measured parameter labels will display • If the problem persists, call
but will be followed by a “?”. DrägerService.
NOTE
Alarm history displays CO2* Reduced Ac-
curacy. When this condition is removed,
the alarm history displays CO2* Reduced
Accuracy Ended.
NOTE
Parameter box (Pbox) question marks (?)
are not transmitted/displayed over the net-
work. They only appear in Pboxes.
Duplicate Device Multiple CO2* devices are connected. • Select desired CO2* device in the
Connected etCO2* parameter menu.
• Disconnect the unwanted CO2*
device.
MultiGas Monitoring
SCIO MultiGas
1 MAC
1 MAC is the anesthetic gas concentration in the 1 MAC corresponds to:
blood at 760 mmHg (1013 hPa), at which 50% of Agent in 100% O2
patients no longer respond to a skin incision with Desflurane 6.0 Vol%
movement. The integrated MAC algorithm is based Enflurane 1.7 Vol%
on the MAC values as indicated on the list. These
Halothane 0.77 Vol%
values are merely guideline values. It is the infor-
mation on the slip accompanying the anesthetic Isoflurane 1.15 Vol%
agents which is binding. Nitrous oxide 105 Vol%
Sevoflurane 2.1 Vol%
Supplement – Infinity® Delta Series VF9.1 35
The MAC values are dependent on the age of the Once the monitor has detected an agent, the pa-
patient. The values indicated in the table relate to rameter box shows a MAC value.
an age of 40 years.
For gas mixtures, the respective multiples for N2O
The Delta series monitor automatically adjusts the and anesthetic agents are added according to the
MAC calculation according to the ambient pressure following equation:
measured by the gas analyzer.
System Compatibility
MAC is not supported by the network.
Troubleshooting
The following table describes alarms in
alphabetical order by alarm message:
Alarm priority Alarm Cause Remedy
Low 2 Mixed Agents A second anesthetic – Wait for the transition phase
agent has been detected. to end after changing anes-
thetic agents.
– Check vaporizer filling level.
– Flush system if necessary.
– Check fresh gas settings.
Medium 3 Mixed Agents A mixture of more than – Wait for the transition phase
two anesthetic agents has to end after changing anes-
NOTE been detected. thetic agents.
The simultaneous – Check vaporizer filling level.
presence of 3 agents – Flush system if necessary.
cannot always be – Check fresh gas settings.
identified.
Medium Inspired MAC High Inspiratory anesthetic gas – Check vaporizer and fresh
concentration exceeds 3 gas setting.
MAC for a period of 30 or
more seconds.
Low MultiGas Module Gas analyzer is discon- – Check cable connections.
Disconnected nected. – If the problem persists, call
DrägerService.
36 Supplement – Infinity® Delta Series VF9.1
Status Messages
Message Condition Suggested action
Duplicate Device Multiple CO2* devices are con- – Select the desired CO2* device in the et-
Connected nected. CO2* Parameter menu.
– Disconnect the unwanted, duplicate CO2*
device.
MultiGas Reduced Warm-up phase in progress – Wait until the warm-up phase has ended
Accuracy before relying on the displayed MultiGas
NOTES
values for clinical evaluation.
– Measured values will display
– If Auto Zero Delay has been selected, al-
but followed by a "?"
low the auto zero to occur.
– Alarm history displays Multi-
– If the problem persists, call DrägerSer-
Gas Reduced Accuracy.
vice.
When this condition is re-
moved, the alarm history dis-
plays MultiGas Reduced
Accuracy Ended.
– Parameter box (Pbox) ques-
tion marks (?) are not trans-
mitted/displayed over the
network. They only appear in
Pboxes.
MultiGas Zero Ac- The zeroing cycle was success- No action is required.
cepted ful.
Supplement – Infinity® Delta Series VF9.1 37
Neuromuscular Transmission (NMT) Monitoring
Precautions
WARNING
To avoid serious injury to the patient, apply
the stimulation electrodes close together as
described. Do not apply the electrodes tran-
scerebrally (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 cardi-
ac rhythm, brain activity, or pain.
Pulse Contour Cardiac Output (PiCCO) Monitoring
Overview of the Infinity PiCCO Pod
The Infinity PiCCO pod has connections for:
up to four (4) invasive pressure transducers
one (1) cardiac output (C.O.) cable
38 Supplement – Infinity® Delta Series VF9.1
3 1 2
5
6 7
1 Initiates a zeroing of all connected pressures
2 Starts a p-CO measurement
3 Transducer slots.
NOTE: On the Infinity PiCCO pod, the transducers are attached to a separate
transducer plate which are available from the applicable manufacturer; purchase them locally or
contact your Dräger representative for information
4 Pulsion blood pressure transducer
5 Transducer plate
6 Monitor connector (to pod communication cable)
7 CO connector
8 10-pin transducer adapter cable
NOTE: Cables are permanently fastened to the back of the Infinity PiCCO pod.
Supplement – Infinity® Delta Series VF9.1 39
To set up the PiCCO Pod
2
3
11
5
10
7 5
12 6
1 Pulsion CVP catheter1 7 Pulsion blood pressure transducer1
2 Pulsion injectate temperature sensor 8 PodCom connection to Delta series monitor
housing1
3 p-CO thermistor cable 9 10-pin transducer adapter cable
4 p-CO intermediate cable 10 Pulsion arterial thermodilution catheters1
5 Infinity PiCCO pod 11 p-CO catheter cable
6 CO connector 12 Pressure transducer interface cable
1
Catheters and blood pressure transducers required for use with the PiCCO pod are only available
from Pulsion Medical Systems. Contact your local sales representative for ordering information.
40 Supplement – Infinity® Delta Series VF9.1
1 Insert a central venous catheter (CVC) into the 8 Connect the “Injectate temperature sensor
patient. housing” to the p-CO thermistor cable.
2 Prepare a pressure monitoring kit for arterial 9 Slide the Arterial Pressure transducer into a slot
pressure monitoring. Fill the transducer kit care- on the front of the transducer plate located be-
fully using the flush clip. Air bubbles in the pres- neath the PiCCO pod. Make sure the pressure
sure lines or in the transducer will influence the label is ART on the monitor.
transmission and can cause measuring errors.
10 Slide the Central Venous Pressure transducer
3 Insert an arterial thermodilution catheter into a into a different slot. Make sure the pressure la-
suitable artery (femoral,brachial or axillary ar- bel is CVP on the monitor.
tery) of the patient. Take care that all air is evac-
11 Connect the PiCCO catheter with the blood
uated from the blood pressure lumen.
pressure transducer.
4 Connect the pressure line of the monitoring kit
12 Use the 10-pin cable to connect the blood pres-
to the lumen of the thermodilution catheter.
sure transducer to the Delta/Delta XL/Kappa
5 Fill the injectate temperature sensor housing, Delta series monitor.
enclosed in the pressure monitoring kit and con-
13 If you have not already done so, enter the pa-
nect it to the distal lumen of the central venous
tient specific input parameters (height and
line.
weight) in the Patient Admit menu.
6 Connect the p-CO thermistor cable to the p-CO
14 A zero adjustment of the pressure transducer is
intermediate cable.
now necessary. The following table outlines ze-
7 Plug the p-CO intermediate cable into the port roing procedures:
labeled “CO” on the PiCCO pod.
Single Transducer Zero Simultaneous “Smart Zero”
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 procedure fails after two attempts, replace the
transducer or consult your hospital’s technical personnel.
Supplement – Infinity® Delta Series VF9.1 41
NOTE 16 Inject the bolus solution into the patient’s blood-
stream only after you see the READY message.
Make sure all patient connections are secure and
A thermodilution curve appears, displaying the
valid blood temperature and injectate temperature
change in blood temperature and a p-CO value
readings are present before initiating a p-CO
is computed.
measurement.
NOTE
15 Press the C.O. Start fixed key on the front of the
PiCCO pod or p-CO Start in the PiCCO main If the READY message fails to appear or appears
selection. A p-CO averaging screen appears on only intermittently, the blood temperature may be
the screen. If you do not see a blood tempera- unstable. Check that all connections are correct
ture baseline, exit the screen and repeat this and that the blood temperature is stable and valid
step. and repeat step 15.
NOTE 17 Repeat step 15 to take an additional measure-
ment, making sure you wait for the READY
– In order to avoid disruption of p-CO thermodi-
message. If a temperature drop is not detected
lution measurement, avoid connecting or dis-
within four minutes, the Averaging screen clos-
connecting any cables or changing any
es, and the current p-CO values will be aver-
menus when measurements are in progress.
aged and saved. You must repeat steps 15 and
– During a measurement, if p-IT or p-BT read-
16 if additional p-CO measurements are neces-
ings become invalid or go out of range, the av-
sary.
eraging screen will disappear.
Cleaning and Disinfecting
IBP - Infinity PiCCO Pod
CAUTION To clean the Infinity PiCCO Pod
Do not autoclave the Infinity PiCCO Pod. 1 Disconnect the Infinity PiCCO pod from the
bedside monitor.
Agents tested by Dräger and shown to have no
2 Clean the Infinity PiCCO pod with a gauze pad
harmful effect at the time of testing on the materials
moistened with soapy water or with an ap-
utilized in the Infinity PiCCO Pod include:
proved cleaning agent.
– Isopropyl alcohol 40%
3 Dry thoroughly with a lint-free cloth.
CAUTION
If using alcohol, it should only be a 40% diluted
To disinfect the Infinity PiCCO Pod
solution.
1 Disconnect the Infinity PiCCO pod from the
Higher concentrations could damage: bedside monitor.
– Compliance™; this cleaning agent may discolor
2 Disinfect the Infinity PiCCO pod with a gauze
soft plastic material
pad moistened with diluted alcohol.
– Sporox II
– Dismozon pur 3 Dry thoroughly with a lint-free cloth.
42 Supplement – Infinity® Delta Series VF9.1
etCO2
Dräger Mainstream CO2 Module, Sensor, and To disinfect the Mainstream Module
Cuvettes
1 Disconnect the sensor cable (including the
SpO2 cable, if using) from the Dräger etCO2
Mainstream Module Mainstream Module.
To clean the Mainstream Module 2 Wipe the module surfaces with a gauze moist-
ened with one of the following:
1 Disconnect the sensor cable (SpO2 cable, if us-
ing) from the Dräger etCO2 mainstream mod- – A 1:3 solution of alcohol should be used
ule.
– A 1:10 solution of sodium hypochlorite
2 Wipe the module surfaces with a cloth moist- (household bleach)
ened with a soap solution.
3 Dry thoroughly with a lint-free cloth.
3 Dry thoroughly with a lint-free cloth.
Mainstream Sensor and Cuvettes
For cleaning and disinfecting instructions for the
sensor and reusable cuvettes, refer to the Dräger
Infinity MCable – Mainstream CO2 IFU.
WARNING
To reduce the risk of infection, remember that
the disposable cuvettes are for single patient
use only and cannot be sterilized.
Supplement – Infinity® Delta Series VF9.1 43
Technical Data
Electromagnetic Compatibility (EMC)
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.
IEC 60601-1-2 Test Level: Compliance level Electromagnetic Environment:
Immunity against (of this 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:
44 Supplement – Infinity® Delta Series VF9.1
Compliance Recommended Separation
Immunity test IEC 60601 Test Level: Level: Distance:
Conducted RF 150 kHz to 80 MHz RMS
rf coupled into lines See note 3
(IEC 61000-4-6)
Radiated rf 80 MHz to 800 GHz 3 V/m
(IEC 61000-4-3)
800 MHz to 2.5 GHz
where 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).
1
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the equipment is used exceeds the applicable RF compliance level above, the
equipment should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the equipment.
2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
3
Applicable for MultiGas Monitor (SCIO) over frequency range 150 KHz to 2.5 GHz and less than 1
V/m above 2.5 GHz.
System Components
Delta/Delta XL base unit
Electrical specifications
Alarm tone sound pressure L(A) alarm Free field measurements (complying with ISO 3744) IEC/Infin-
tone sequence ity
– High alarms - 56dB(A) to 69dB(A) / 56dB(A) to 76dB(A)
– Medium-priority alarms - 56dB(A) to 69dB(A) / 54dB(A) to
72dB(A)
– Low-priority alarms - 52dB(A) to 65dB(A) / 41dB(A) to
58dB(A)
NOTE
The Infinity alarm volume must be set at 20% or higher to com-
ply with the minimum audio sound pressure of 45 db specified
in standard 60601-2-49.
Supplement – Infinity® Delta Series VF9.1 45
Monitoring Accessories
Infinity PiCCO Pod
Physical attributes
Size (H x W x D) 110 x 205 x 40 mm (4.3 x 8.1 x 1.6 in)
Weight < 0.9 kg (1.9 lb)
NOTE: Weight includes four transducer cables and excludes mounting clamp and mounting rod.
User Controls Fixed keys (C.O. Start, IBP Zero)
Connections 4 invasive pressures, C.O., single cable connecting pod to monitor
Degree of protection against IPX1 (protected against harmful effects of dripping water) per IEC 60529
ingress of water
Electrical specifications
Power source Powered directly from the monitor
Protection against electric Type CF
shock
Mode of operation Continuous
Defibrillation protection Yes
Environmental requirements
Temperature range Operating: 5 to 45 °C (41to 113 °F)
Storage: -40 to 70 °C (-4 to 140 °F)
Relative humidity Operating:10 to 95 %, non-condensing
Storage: 10 to 95 % (with packaging)
Atmospheric pressure Operating:485 to 795 mmHg (65 to 106 kPa)
Storage: 375 to 795 mmHg (50 to 106 kPa)
Mainstream CO2 Module and Sensor
Physical specifications
Size (H x W x D) Module: 150 x 95 x 43 mm (5.9 x 3.7 x 1.7 in)
Sensor: 32 x 55 x 22 mm (1.26 x 2.17x 0.87 in)
Weight Module: 0.3 kg or less (0.66 lb or less, without sensor connected)
Sensor: 30 g or less (0.066 lb or less, without cable)
Cable length 2.5 m (98.4 in)
Connections Module: Dräger mainstream CO2 sensor port, SpO2 input port
Cuvette internal volume Adult 6.7 cm3 (0.41 in3)
(dead space) Pediatric 4.6 cm3 (0.28 in3)
Cuvette effective dead space Adult 4.3 cm3 (0.26 in3)
volume Pediatric 1.9 cm3 (0.12 in3)
Protection against liquid in- Module: IPX1 (protected against harmful effects of dripping water) per
gress IEC 60529
Sensor: IP64 (dust-tight, protected against splashing water) per IEC
60529
Electrical specifications
Power source Powered directly from monitor
46 Supplement – Infinity® Delta Series VF9.1
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)
Invasive Blood Pressure
Frequency ranges DC to 8, 16 or 32 Hz ± 10% (user selectable)
Accuracy ±1 mmHg or ±1 % exclusive of transducer (whichever is greater)
Monitoring Specifications
WARNING
The following parameters are not monitored in
neonatal mode: arrhythmia, cardiac output,
ST, and all MultiGas parameters.
ECG
Description Value
V/s pacer detected 3.18 V/s
Supplement – Infinity® Delta Series VF9.1 47
Respiration
Description Value
Measurement range: Range: 0 - 154 breaths per min
Pulse Contour Cardiac Output (PiCCO)
Additional technical data
Measurement method PCCI Continuous Pulse Contour Analysis
PCCO Continuous Pulse Contour Analysis
p-SVI Continuous Pulse Contour Analysis
SVV Continuous Pulse Contour Analysis
p-SVR Continuous Pulse Contour Analysis
p-SVRI Continuous Pulse Contour Analysis
dPmax Continuous Pulse Contour Analysis
GEF Transpulmonary Thermodilution
p-CO Transpulmonary Thermodilution
GEDV Transpulmonary Thermodilution
GEDVI Transpulmonary Thermodilution
EVLW Transpulmonary Thermodilution
EVLWI Transpulmonary Thermodilution
PVPI Transpulmonary Thermodilution
Display resolution PCCI 0.01 L/min/m2
PCCO 0.01 L/min
p-SVI 1 ml/m2
SVV 1%
p-SVR 10 dyn.sec. cm-5
p-SVRI 10 dyn.sec. cm-5/m2
dPmax 1 mmHg/s
GEF 1%
p-CO 0.01 L/min
GEDV 1 ml
GEDVI 1 ml/m2
EVLW 1 ml
EVLWI 1 ml/kg
PVPI 0.1
p-BT 0.1 ºC (1 ºF)
Measurement range PCCI 0.01 to 15 L/min/m2
PCCO 0.25 to 25 l/m
p-SVI 1 to 125 ml/m2
SVV 0 to 50%
p-SVR 0 to 30000 dyn.sec. cm-5
p-SVRI 0 to 30000 dyn.sec. cm-5/m2
dPmax 200 to 5000 mmHg/s
GEF 1 to 99%
p-CO 0.25 to 25 L/min
GEDV 40 to 4800 ml
GEDVI 80 to 2400 ml/m2
EVLW 10 to 5000 ml
EVLWI 0 to 50 ml/kg
PVPI 0.1 to 10
p-BT 25 ºC to 43 ºC (77 ºF to 109 ºF)
48 Supplement – Infinity® Delta Series VF9.1
Additional technical data
Accuracy PCCI Not applicable
PCCO Coefficient of variation ≤ 3%
p-SVI Not applicable
SVV Not applicable
p-SVR Not applicable
p-SVRI Not applicable
dPmax Not applicable
GEF Not applicable
p-CO Coefficient of variation ≤ 1%
GEDV Coefficient of variation ≤ 2%
GEDVI Not applicable
EVLW Not applicable
EVLWI Not applicable
PVPI Not applicable
Zero balance range ±200mmHg
Non-Invasive Blood Pressure (NBP)
Pressure measurement range Systolic NBP: 30 to 250 mmHg (4.0 to 33.3 kPa)
(Adult - 270 mmHg, 36.0 kPa) Mean NBP: 20 to 230 mmHg (2.7 to 30.7 kPa)
Diastolic NBP: 10 to 210 mmHg (1.3 to 28.0 kPa)
Pressure measurement range Systolic NBP: 30 to 170 mmHg (4.0 to 22.7 kPa)
(Pediatric - 180 mmHg, 24.0 kPa) Mean NBP: 20 to 150 mmHg (2.7 to 20.0 kPa)
Diastolic NBP: 10 to 130 mmHg (1.3 to 17.3 kPa)
Pressure measurement range Systolic NBP: 30 to 130 mmHg (4.0 to 17.3 kPa)
(Neonatal - 140 mmHg, 18.7 kPa) Mean NBP: 20 to 110 mmHg (2.7 to 14.7 kPa)
Diastolic NBP: 10 to 100 mmHg (1.3 to 13.3 kPa)
Connections Quick-release hose connector with single airway
Default inflation pressure Adult (270): 160 mmHg ±10mmHg (21.3 kPa ± 1.3 kPa)
Pediatric (180): 120 mmHg ±10 mmHg (16.0 kPa ± 1.3 kPa)
Neonatal (140): 110 mmHg ±10 mmHg (14.7 kPa ± 1.3 kPa)
Inflation pressure after a valid mea- Adult (270): Previous NBPSYS + 25 mmHg (+ 3.3 kPa)
surement (±10 mmHg) Pediatric (180): Previous NBPSYS + 25 mmHg (+ 3.3 kPa)
Neonatal (140): Previous NBPSYS + 30 mmHg (+ 4.0 kPa)
Inflation pressure after an alarm Adult (270): 160 mmHg ±10 mmHg (21.3 kPa ± 1.3 kPa)
Pediatric (180): 120 mmHg ±10 mmHg (16.0 kPa ± 1.3 kPa)
Neonatal (140): 110 mmHg ±10 mmHg (14.7 kPa ± 1.3 kPa)
Maximum inflation pressure Adult (270): 265 mmHg ±5 mmHg (35.3 kPa ± 0.7 kPa)
Pediatric (180): 180 mmHg ±10 mmHg (24.0 kPa ± 1.3 kPa)
Neonatal (140): 142 mmHg ±10 mmHg (18.9 kPa ± 1.3 kPa)
Minimum inflation pressure Adult (270): 110 mmHg ±10 mmHg (14.7 kPa ± 1.3 kPa)
Pediatric (180): 90 mmHg ±10 mmHg (12.0 kPa ± 1.3 kPa)
Neonatal (140): 70 mmHg ±10 mmHg (9.3 kPa ± 1.3 kPa)
Maximum measurement time Adult (270): 2 min ±1 sec
Pediatric (180): 2 min ±1 sec
Neonatal (140): 90 sec ±1 sec
Supplement – Infinity® Delta Series VF9.1 49
Maximum measurement time Adult (270): 3 min ±1 sec
including a retry Pediatric (180): 3 min ±1 sec
Neonatal (140): 90 sec ±1 sec
Software safety cut-off Adult (270): 273 ±3 mmHg (36.4 kPa ± 0.4 kPa)
Pediatric (180): 215 ±3 mmHg (28.7 kPa ± 0.4 kPa)
Neonatal (140): 153 ±3 mmHg (20.4 kPa ± 0.4 kPa)
Hardware safety cut-off Adult (270): 300 ±30 mmHg (40.0 kPa ± 4.0 kPa)
Pediatric (180): 300 ±30 mmHg (40.0 kPa ± 4.0 kPa)
Neonatal (140): 157 ±8 mmHg (20.9 kPa ± 1.1 kPa)
Static cuff accuracy ±3 mmHg (± 0.4 kPa)
Calibration range Adult and Pediatric:10 to 260 mmHg ±3 mmHg (1.3 to 34.7 kPa ±
0.4 kPa)
Neonatal: 10 to 150 mmHg ±3 mmHg (1.3 to 20.0 kPa ± 0.4 kPa)
50 Supplement – Infinity® Delta Series VF9.1
Pulse Oximetry (Masimo SET SpO2 via Pod)
Description Value
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 bpm ±3
Pulse Rate (bpm) - During motion conditions:(3,4)
Adults, pediatrics, neonates bpm ±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.
Supplement – Infinity® Delta Series VF9.1 51
Pulse oximetry (Nellcor Oximax SpO2 via pod)
Parameter display Saturation (%SpO2), pulse rate
Measurement range %SpO2: 1 - 100%
Pulse rate:25 - 239 /min
Measurement accuracy, adult mode (1, 2, 4):
Saturation (%SpO2):
0 to 60% not specified
60 to 80% sensor-specific as follows:
Nellcor:
OxiMAX MAX-A, OxiMAX MAX-AL, OxiMAX MAX-P,
OxiMAX MAX-N, OxiMAX MAX-I, OxiMAX MAX-FAST ±3
Nellcor:
SC-A, MAX-R, OxiCliq A, OxiCliq P, OxiCliq N, OxiCliq I,
D-YS, DS-100A, OXI-A/N, OXI-P/I not specified
70 to 100% sensor-specific as follows:
Nellcor:
OxiMAX MAX-A, OxiMAX MAX-AL, OxiMAX MAX-P,
OxiMAX MAX-N, OxiMAX MAX-I, OxiMAX MAX-FAST
SC-A ±2
Nellcor:
OxiCliq A, OxiCliq P, OxiCliq N, OxiCliq I ±2.5
Nellcor:
D-YS, DS-100A, OXI-A/N, OXI-P/I ±3
Nellcor:
D-YS with D-YSE Ear Clip, D-YS with D-YSPD Spot Clip ±3.5
80 to 100% sensor-specific as follows:
Nellcor:
MAX-R ±3.5
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
52 Supplement – Infinity® Delta Series VF9.1
CO2 Concentrations Via Mainstream CO2
Module and Sensor
Description Value
Parameter display etCO2*, iCO2*, RRc*
Measuring principle Dual wavelength infrared absorption
Measurement range etCO2* and iCO2*: 0 to 99mmHg
(0 to 13.2 kPa or 0 to 13.0 Vol% at sea level)
RRc*: 3 to 90 breaths/min
Measurement accuracy Disposable cuvette and reusable cuvette
etCO2* and iCO2*:
±0.26 Vol% or ±5% rel.
±0.27 kPa or ±5% rel.
±2.00 mmHg or ±5% rel.
(depending on which value is higher)
RRc*:
±1 breaths/min between 3 and 80 breaths/min
±2 breaths/min at > 80 breaths/min
Pressure drop of the cuvettes Adult cuvette
<0.1 mbar at 2.5 L/min
<0.2 mbar at 15 L/min
<0.4 mbar at 30 L/min
<1.2 mbar at 60 L/min
Pediatric cuvette
<0.1 mbar at 2.5 L/min
<1.4 mbar at 15 L/min
<5.4 mbar at 30 L/min
<20.0 mbar at 60 L/min
Compliance of the cuvettes <0.3 mL/mbar (or mL/hPa or mL/cmH2O)
Leakage of the cuvettes <3 mL/min (Disposable cuvette)
<0.3 mL/min (Reusable cuvette)
Resolution etCO2* and iCO2*: 1 mmHg (0.1 kPa or 0.1 Vol%)
RRc*: 1 breath/min
Zeroing Verify once a day.
Zero when moving the sensor from one module to another.
Zeroing time: <10 s
Calibration Verify once a month.
Calibration check time: <10 s
Alarm limit resolution etCO2*, iCO2*: 1 mmHg (0.1 kPa)
RRc*: 1 breath/min
Apnea detection Adult: Yes
Pediatric: Yes
Total system response time <200 ms (rise time plus delay time)
Rise time <35 ms
Supplement – Infinity® Delta Series VF9.1 53
Description Value
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 humidi- The cuvette windows are indirectly heated through the
ty/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 re-
placed).
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.
How Performance is affected by Barometric :
Pressure
The user has to manually set the total gas pressure (ambient or barometric pressure) in the monitor, the
mainstream CO2 sensor uses to automatically compensate for pressure effects.
The remaining bias error is less than 2 % of reading (i.e., 2 % relative) for ambient pressures between
57 and 110 kPa, which error includes imperfection of foreign gas compensation (O2, N2O, He).
When users select the atmospheric pressure, the Draeger mainstream CO2 module incorporates com-
pensation for pressure effects in accordance to the following table:
CO2* value prior to Correction Factors for Atmospheric Pressure
correct Atm pressure
Atm. pr. Atm. pr. Atm. pr. Atm. pr. Atm. pr. Atm. pr.
106.3 kPa 101.3 kPa 96.3 kPa 91.3 kPa 86.3 kPa 81.3 kPa
1 kPa (7.5 mmHg) 0.981 1 1.020 1.042 1.066 1.093
5 kPa (37.5 mmHg) 0.969 1 1.033 1.069 1.0109 1.153
10 kPa (75.0 mmHg) 0.969 1 1.033 1.070 1.110 1.155
NOTE: This table is applicable to the Gas Compensation of Air.
54 Supplement – Infinity® Delta Series VF9.1
How performance is affected by interfering
gases and vapors
NOTE
Regarding interfering gases and vapors:
These additional errors are not corrected for auto-
matically through the Gas Compensation selec-
tion.
Gas or Vapor Concentration CO2 reading in Vol% at 0 Vol.% CO2
Halothane, 5 Vol% 0.02
Enflurane, 5 Vol% 0.03
Isoflurane, 5 Vol% 0.02
Sevoflurane, 5 Vol% 0.02
Desflurane, 20 Vol% 0.00
Ethanol, 4 % 0.00
Isopropanol, 1 Vol% 0.00
Acetone, 1 % 0.00
Methane, 3 Vol% < 0.02
NO, 100 ppm 0.01
NO2, 50 ppm 0.00
CO, 4 Vol% 0.00
Freon R21, 100 Vol.% 0.07
Freon R134a, 100 Vol.% 0.19
Water vapor, 37 °C saturated 0.01
NOTE: Given readings are pure interfering gas effects, balance N2 (if applicable, without CO2 content).
CO2 reading of mixtures (for example, CO2, N2O, O2, anesthetic agent or CO2, O2, N2, water vapor) is
within specified tolerance.
Supplement – Infinity® Delta Series VF9.1 55
Approved Options and Accessories
NOTE
All Draeger approved pods and associated acces-
sories 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 be-
cause they are not approved in all countries.
Temperature probe covers
7014616 Core temperature probe covers, 20 cm, 10 pcs (contains latex)
MS40243 Core temperature probe covers, 20 cm, 100 pcs (latex-free)
ECG leads
Standard ECG Lead Sets (Single Pin Version - for Direct Connection to MultiMed Plus and Mul-
tiMed Plus OR)
MP03401 ECG 3-lead, grabber, 1 m, single pin connector, IEC1 (European color code)
MP03402 ECG 3-lead, grabber, 1 m, single pin connector, IEC2 (AHA color code)
MP03403 ECG 5-lead, grabber, 1/1.5 m, single pin connector, IEC1 (European color code)
MP03404 ECG 5-lead, grabber, 1/1.5 m, single pin connector, IEC2 (AHA color code)
MP03405 ECG 6-lead, grabber, 1/1.5 m, single pin connector, IEC1 (European color code)
MP03406 ECG 6-lead, grabber, 1/1.5 m, 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, 1 m, dual pin connector, IEC1 (European color code)
MP03412 ECG 3-lead, grabber, 1 m, dual pin connector, IEC2 (AHA color code)
MP03413 ECG 5-lead, grabber, 1/1.5 m, dual pin connector, IEC1 (European color code)
MP03414 ECG 5-lead, grabber, 1/1.5 m, dual pin connector, IEC2 (AHA color code)
MP03415 ECG 6-lead, grabber, 1/1.5 m, dual pin connector, IEC1 (European color code)
MP03416 ECG 6-lead, grabber, 1/1.5 m, dual pin connector, IEC2 (AHA color code)
MP03417 ECG 5-lead C, grabber, 1 m, dual pin connector, IEC1 (European color code)
MP03418 ECG 5-lead C, grabber, 1 m, dual pin connector, IEC2 (AHA color code)
56 Supplement – Infinity® Delta Series VF9.1
Invasive Blood Pressure (IBP)
IBP accessories
5196998 Hemo pod adapter, Abbott/Medex/(Transtar) (One for each Hemo2 and two for each He-
mo4/HemoMed pod)
Pulse Oximeter (SpO2) NOTE
LNCS intermediate cables are designed to last
NOTE approximately 17,000 hours while actively moni-
For Masimo sensors, unique part numbers for toring SpO2 (for example 4 years if monitoring oc-
USA and Japan apply. curs 12 hours a day). This duration is monitored
by a chip inside the cable.
NOTE
Always refer to the Directions for Use accompa-
nying the Masimo patient accessories.
LNCS Adhesive SpO2 Sensors
ROW PN USA PN Japan PN Description
MP00790 MP03011 MP03089 Masimo SpO2-Sen LNCS Adtx Bx20
MP00793 MP03012 MP03090 Masimo SpO2-Sen LNCS Pdtx Bx20
MP00791 MP03013 MP03091 Masimo SpO2-Sen LNCS Inf Bx20
MP00792 MP03014 MP03092 Masimo SpO2-Sen LNCS Neo Bx20
MP00794 MP03015 MP03093 Masimo SpO2-Sen LNCS NeoPt Bx20
LNCS Adhesive Trauma Sensors
ROW PN USA PN Japan PN Description
MP03191 MP03016 MP03094 Masimo TraumaSen LNCS Adt Bx20
MP03192 MP03017 MP03095 Masimo TraumaSen LNCS Neo Bx20
MP03193 MP03018 MP03096 Masimo TraumaSen LNCS Inf/Ped Bx20
CAUTION: With specialty sensors, the sensor-off detection performance may be compromised.
NOTE: Trauma Sensors are only for use with Masimo SET technology.
Supplement – Infinity® Delta Series VF9.1 57
LNCS Reusable SpO2 Sensors
ROW PN USA PN Japan PN Description
MP00796 MP03019 MP03097 Masimo SpO2-Sensor LNCS DC-I
MP00795 MP03020 MP03098 Masimo SpO2-Sensor LNCS DC-IP
MP00788 MP03021 MP03099 SpO2 Masimo Sen LNCS-TC-I Ear*
MP00799 MP03022 MP03101 SpO2 Masimo Sen LNCS-TF-I*
MP00789 MP03023 MP03102 SpO2 Masimo Sen LNCS-YI Multi
MP02993 MP03024 MP03103 SpO2 Masimo Sen LNCS DBI Adult
NOTE: Masimo does not make any claims regarding
motion for this sensor.
* NOTE: Only for use with Masimo SET technology.
Assorted Sensor Accessories
ROW PN USA PN Japan PN Description
7496933 MP03045 MP03147 SpO2 Posey Wrap Masimo 12 pcs
7496917 MP03046 MP03148 SpO2 Wrap for Masimo LNOP YI
7496909 MP03047 MP03149 SpO2 Masimo Petite Wrap 100 pcs
7496875 MP03048 MP03150 SpO2 Masimo adh square, 12 pcs
7496891 MP03049 MP03151 SpO2 Masmiso FOAMWRAPLNOP 12PC
MP03197 MP03050 MP03152 Headband for LNOP/LNCS TF-I
MP03198 MP03051 MP03153 Adhesive Pad LNOP/LNCS TF-I
RD SET Adhesive SpO2 Sensors
ROW PN USA PN Japan PN Description
MS33726 MS33745 MS33764 Masimo SpO2 RD SET Adt Bx20
MS33727 MS33746 MS33765 Masimo SpO2 RD SET Pdt Bx20
MS33728 MS33747 MS33766 Masimo SpO2 RD SET Inf Bx20
MS33729 MS33748 MS33767 Masimo SpO2 RD SET Neo Bx20
MS33730 MS33749 MS33768 Masimo SpO2 RD SET NeoPt Bx20
58 Supplement – Infinity® Delta Series VF9.1
RD SET Adhesive Trauma Sensors
ROW PN USA PN Japan PN Description
MS40088 MS40086 MS40087 RD-SET Trauma Adt Bx20
MS40091 MS40089 MS40090 RD-SET Trauma Inf/Pd Bx20
MS40094 MS40092 MS40093 RD-SET Trauma Neo Bx20
CAUTION: With specialty sensors, the sensor-off detection performance may be compromised.
NOTE: Trauma Sensors are only for use with Masimo SET technology.
RD SET Reusable SpO2 Sensors
ROW PN USA PN Japan PN Description
MS33740 MS33759 MS33778 Masimo SpO2-Sen RD SET DC-I
MS33741 MS33760 MS33779 Masimo SpO2-Sen RD SET DCIP
MS40067 MS40065 MS40066 Masimo SpO2 RD-SET TC-I*
MS40070 MS40068 MS40069 Masimo SpO2 RD-SET YI
MS40073 MS40071 MS40072 Masimo SpO2 RD-SET TF-I*
*NOTE: Only for use with Masimo SET technology.
RD SET Adapter Cables
ROW PN USA PN Japan PN Description
MS33731 MS33750 MS33769 RD to LNOP adapter
MS33732 MS33751 MS33770 RD to LNCS adapter
MS33733 MS33752 MS33771 RD to MM adapter cable
MS33734 MS33753 MS33772 RD to M-LNCS adapter
RD SET Intermediate Cables
PN Description
MS34436 SpO2 intermediate cable Masimo RD-SET, 1.2 m
MS34437 SpO2 intermediate cable Masimo RD-SET, 3 m
NOTE: For connecting Masimo RD SET sensors to the respective Masimo SET Pod. For additional
instructions refer to Instructions for Use Infinity Delta Series, Infinity Patient Monitoring Series Software
VF9, Chapter 18.
Nellcor FLEXMAX Reusable Sensors
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.
Supplement – Infinity® Delta Series VF9.1 59
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, inter-
nal volume 7 mL), 10 pcs.
MP01063 etCO2 cuvette pediatrics, disposable (resistance 2.4 mbar at 30 L/min, in-
ternal volume 5 mL), 10 pcs.
Infinity PiCCO Pod
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 CO injectate thermistor cable
1 PiCCO pod CO catheter cable
1 PiCCO pod CO 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
Infinity PiCCO Pod Connecting Cables
PN Description
MS22532 Dräger 10-pin Transducer Adapter Cable (Adapter cable to connect PUL-
SION 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 CO injectate thermistor cable (Connects the PiCCO PV4046
injectate sensor housing to the CO intermediate cable).
MS16918 PiCCO pod CO catheter cable (Connects the PiCCO arterial thermodilution
catheter to the CO intermediate cable).
MS16916 PiCCO pod CO intermediate cable, 1.5 m (Connects the PiCCO CO cath-
eter cable and CO thermistor cable to PiCCO pod).
NOTE: All disposables are delivered by PULSION directly.
60 Supplement – Infinity® Delta Series VF9.1
This supplement only applies to
Infinity® Delta SW VF9.1
with the Serial No.:
If no Serial No. has been filled in by Dräger, this
supplement is provided for general information
only and is not intended for use with any specific
machine or unit.
Manufacturer in Europe, Middle East, Africa, Latin
America, Asia Pacific distributed by
Draeger Medical Systems, Inc.
3135 Quarry Road Drägerwerk AG & Co. KGaA
Telford, PA 18969-1042 Moislinger Allee 53 – 55
U.S.A. D-23542 Lübeck
(215) 721-5400 Germany
(800) 4DRAGER +49 451 8 82-0
(800 437-2437) FAX +49 451 8 82-20 80
FAX (215) 723-5935 http://www.draeger.com
http://www.draeger.com
MS32082 – RI 01 en
© Drägerwerk AG & Co. KGaA
Edition: 2 – 2020-05
(Edition: 1 – 2014-11)
Dräger reserves the right to make modifications
to the device without prior notice.