Supplement Infinity Delta Series...A-2000, BIS ®, BISx® ... For this product, users, service personnel, and ex-perts are defined as target groups. These target groups must have received

Supplement

Infinity® Delta Series

Infinity® Patient Monitoring SeriesSoftware VF9.1

WARNINGTo properly use this medical device, read and comply with the instructions for use and this supplement.

Supplement – Infinity® Delta Series VF9.1 3

Contents

Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3For your safety and that of your patients . . . . . 6

Mandatory reporting of adverse events . . . 6General Supplement Notes . . . . . . . . . . . . . . . 6

Definition of Target Groups . . . . . . . . . . . . . 6Device Symbols . . . . . . . . . . . . . . . . . . . . . . . . 7Monitor Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Main Menu Setup . . . . . . . . . . . . . . . . . . . . 7Unit Manager . . . . . . . . . . . . . . . . . . . . . . . 7

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9General Requirements - Alarm Setup. . . . . 9Alarm History Table. . . . . . . . . . . . . . . . . . 11Alarm Latching . . . . . . . . . . . . . . . . . . . . . . 11

ECG and Heart Rate . . . . . . . . . . . . . . . . . . . . 12ECG Setup Menu . . . . . . . . . . . . . . . . . . . . 12

Arrhythmia Monitoring . . . . . . . . . . . . . . . . . . . 13Arrhythmia Ranges and Defaults . . . . . . . . 13

Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Non-Invasive Blood Pressure. . . . . . . . . . . . . . 15

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 15NBP Setup . . . . . . . . . . . . . . . . . . . . . . . . . 17

Continuous Non-invasive Arterial Blood Pressure (CNAP) Pod . . . . . . . . . . . . . . . . . . . 18

CNAP Calibration . . . . . . . . . . . . . . . . . . . . 19Status Messages . . . . . . . . . . . . . . . . . . . . 19

Maintenance (CNAP) . . . . . . . . . . . . . . . . . . . . 19Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 19Definition of Maintenance Concepts . . . . . . 20Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . 21Visual Inspection. . . . . . . . . . . . . . . . . . . . . 21Inspection/ Safety Check . . . . . . . . . . . . . . 21Metrological checks . . . . . . . . . . . . . . . . . . 22Preventive Maintenance . . . . . . . . . . . . . . . 22

Pulse Oximetry (SpO2). . . . . . . . . . . . . . . . . . . 22Quick Reference Table - SpO2 Setup . . . . 23New Status Message . . . . . . . . . . . . . . . . . 24

Dräger Mainstream etCO2 Monitoring . . . . . . 24Application . . . . . . . . . . . . . . . . . . . . . . . . . 24Precautions . . . . . . . . . . . . . . . . . . . . . . . . 24Connection. . . . . . . . . . . . . . . . . . . . . . . . . 26Connecting the Sensor . . . . . . . . . . . . . . . 27Getting Started. . . . . . . . . . . . . . . . . . . . . . 28Display Features . . . . . . . . . . . . . . . . . . . . 28Capnograms . . . . . . . . . . . . . . . . . . . . . . . 31Troubleshooting . . . . . . . . . . . . . . . . . . . . . 32Status Messages . . . . . . . . . . . . . . . . . . . . 35

MultiGas Monitoring . . . . . . . . . . . . . . . . . . . . 35SCIO MultiGas. . . . . . . . . . . . . . . . . . . . . . 35Status Messages . . . . . . . . . . . . . . . . . . . . 37

Neuromuscular Transmission (NMT) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Precautions . . . . . . . . . . . . . . . . . . . . . . . . 38Pulse Contour Cardiac Output (PiCCO) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Overview of the Infinity PiCCO Pod. . . . . . 38To set up the PiCCO Pod. . . . . . . . . . . . . . 40

Cleaning and Disinfecting . . . . . . . . . . . . . . . . 42IBP - Infinity PiCCO Pod . . . . . . . . . . . . . . 42etCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . 44Electromagnetic Compatibility (EMC) . . . . 44System Components . . . . . . . . . . . . . . . . . 45Monitoring Accessories . . . . . . . . . . . . . . . 46Monitoring Specifications. . . . . . . . . . . . . . 47

Approved Options and Accessories . . . . . . . . 56Temperature probe covers. . . . . . . . . . . . . 56ECG leads . . . . . . . . . . . . . . . . . . . . . . . . . 56Invasive Blood Pressure (IBP). . . . . . . . . . 57Pulse Oximeter (SpO2) . . . . . . . . . . . . . . . 57Mainstream etCO2. . . . . . . . . . . . . . . . . . . 60Infinity PiCCO Pod. . . . . . . . . . . . . . . . . . . 60Infinity PiCCO Pod Connecting Cables . . . 60

4 Supplement – Infinity® Delta Series VF9.1

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Infinity® Delta Series Instructions for use

Software SW VF9.1

©Drägerwerk AG & Co. KGaA, 2014.

All rights reserved.

Printed in the United States of America.

Reproduction in any manner, in whole or in part, in English or in any other languages, except for brief excerpts in reviews and scientific papers, is prohib-ited without prior written permission of Dräger.

Before using any Dräger devices, carefully read all the manuals that are provided with your device. Pa-tient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

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.

All rights reserved

Some graphics courtesy of Covidien

Unpublished rights reserved under the copyright laws of the United States.

RESTRICTED RIGHTS LEGEND Use duplication or disclosure by the Government is subject to re-strictions as set forth in subparagraph (c)(1)(ii) of the Rights in Technical Data & Computer Software clause at DFARS 252 227:7013

The capnography component of this product is cov-ered by one of the following US patents: 6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applica-tions pending.

All other brand or product names are trademarks of their respective owners.


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

Definition of Target Groups

For this product, users, service personnel, and ex-perts are defined as target groups.

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.

Users

Users are persons who use the product in accor-dance with its intended use.

Service Personnel

Service personnel are persons who are responsible for the maintenance of the product. Service person-nel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.

Experts

Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product.

Training

Training for users is available via the responsible Dräger organization (see www.draeger.com).

WARNINGA WARNING statement provides important information about a potentially hazardous sit-uation which, if not avoided, could result in death or serious injury.

CAUTIONA CAUTION statement provides important infor-mation about a potentially hazardous situation which, if not avoided, may result in minor or mod-erate injury to the user or patient, or in damage to the equipment or other property.

NOTEA NOTE provides additional information intended to avoid inconveniences during operation.


Device Symbols

The following table describes new and revised symbols that appear on the monitor and its accessories:

Monitor Setup

Main Menu Setup

Date & Time is no longer a selection in the Main Menu > Monitor Setup > Monitor Options sub-menu. Date and time changes are only permitted

by qualified hospital technical personnel or Dräger Service personnel in the password-protected Service menu.

Unit Manager

The Unit Manager menu lets supervisory person-nel configure monitoring functions for the clinical staff. Access to this menu is restricted by a pass-word.

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


Unit Manager Menu

Menu Item Description Available SettingsThe 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 Reminder tone (Alarm Control 1 submenu)

A reminder tone to indicate all alarms are OFF permanently.

– Enabled (default)– Disabled

Enabled when the All Alarms OFF feature is set to Enabled. A remind-er tone sounds every 30 seconds at 50 % volume.

Audio OFF Re-minder (Alarm Control 1 sub-menu)

Allows you to set a reminder when the Alarm Volume feature is set to Disabled.

– Enabled (default) - When the alarm volume is set to Disabled, a reminder tone sounds every 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

when you press the Code fixed key.

NOTE: The central station continues to sound audio alarms after you press the Code key.

– Yes - Temporarily sets the alarm volume and the minimum alarm volume to OFF when you press the Code key.

– No (default) - The alarm volume and the minimum alarm volume settings do not change when you press the Code key (i.e. re-tains prior settings).


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-olution

Default State Default Alarm Setting

iCO2/iCO2* 2 to 10 mmHg (0.3 to 1.3 kPa) (upper limit only) increments of 1 mmHg or 0.1 kPa

ON High: 4 mmHg (0.5 kPa)

PLS/PLS* 30 to 240 in increments of 5 bpm ON Adult:Low 45 bpmHigh 120 bpm

Pediatric:Low 50 bpmHigh 150 bpm

Neonatal:Low 80 bpmHigh 180 bpm


Auto Set Alarm Limits

Alarm Limits Table

Function Description Available Settings

Auto Set Sets alarm limits based on current values: Not applicable

NOTE:• The monitor recalculates the upper

and lower alarm limits based on the parameter values in the Current column.

• Auto Set applies to all displayed parameters and ST parameters only.

• If a calculated limit value falls outside the range for that parameter, the parameter’s alarm limits remain unchanged.

Parameters Upper Limit Lower Limit

Ta, T1a, T1b, T2a, T2b, T3a, T3b

< 107% of cur-rent value


ΔT1, ΔT2, ΔT3, PVC/min, iCO2, iCO2*

No change No change

SpO2/SpO2* Adults 100

Neonates 98

Current value - (value x 5%)

ΔSpO2% Current value + 20%

None

ST Current value +2.0 mm

Current value -2.0 mm

MultiGas Agent < 105% of cur-rent value


BIS No change No change

TOF-Cnt No change No change

PCCO Current value + 30%

Current value - 30%

PCCI Current value + 30%

Current value - 30%

MultiGas O2 100% 21%

tp < 125% of cur-rent value


All others Current value + 25%

Current value -20%


Alarm History Table

The monitor stores up to 50 physiological alarm events for each patient (the oldest log entry is over-written). Events are deleted when the patient is dis-charged. Data is stored in the monitor and remains with the patient during Pick and Go transports. Data also survives power shutdowns. The Alarm Histo-ry table records all high-priority and medium-priori-ty alarms as well as selected low-priority alarms for

MultiGas and Dräger Mainstream CO2 monitoring (e.g., alarms relating to module disconnection). The Alarm History table also records every activation and deactivation of cardiac bypass mode, every change of patient category, and records whenever you perform an All Alarms OFF/All Alarms Paused or Audio Paused/Alarm Silence. Switch-ing the device on and off is not recorded.

Alarm Latching

Some alarms are latched: they continue to annun-ciate visually and audibly until you acknowledge them manually, even if the condition that caused

the alarm no longer exists. Other alarms may be latched only partially, as indicated in the following table:

To acknowledge (or silence) a latched alarm, press the Alarm Silence fixed key.

NOTEHigh-priority and medium-priority alarms do not latch in OR mode.

Alarm Latching BehaviorHigh-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.


ECG and Heart Rate

ECG Setup Menu

Menu selection Description Available SettingsThe ECG Options submenu

This submenu allows you to configure the following functions:Pacer Detection Determines the monitor’s ability to

identify pacemaker pulse. Allows user to enable/disable pacer detection or choose more advanced Fusion selec-tion.

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.

In basic mode:

– Select ON to enable pacemaker de-tection.

– Select OFF (default) to disable pace-maker detection.

Pacer Detection (continued)

Observe the following:

– Select Fusion mode only in situa-tions where it becomes necessary to suppress repeated false asystole and/or false low heart rate alarms.

– Before selecting Fusion mode, be certain that the patient has a bipolar pacemaker (external or implanted) and that it is accurately pro-grammed as appropriate for that patient.

– Do not use Fusion mode if you are uncertain as to what type of pace-maker is being used.

In advanced mode:

– Select ON to enable pacemaker de-tection.

– Select OFF (default) to disable pace-maker detection.

– Select Fusion to enable pacer detec-tion, but minimize pacer tail rejection to reduce missed detection of pseudo-fused paced beats, which results in false asystole alarms.


Arrhythmia Monitoring

Arrhythmia Ranges and Defaults

Parameter Alarm Grade Default

Rate (default) Count (default) Alarm Archive Factory 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-

crements of 105 to 15 (10) Incre-ments of 1

Str./Rec.

RUN MED Not adjustable (VT rate)

Not adjustable (3 to VT rate - 1)

Str./Rec.

AIVR MED Not adjustable = (VT rate - 1)

Not adjustable (3) OFF

SVT MED 120 to 200 (150) In-crements of 10

3 to 10 (3) Incre-ments of 1

Str./Rec.

TACH MED 100 to 200 (130) In-crements of 10

5 to 15 (8) Incre-ments of 1

OFF

BRDY MED 30 to 105(50)Increment of 5

Not adjustable (8) OFF

CPT LOW Not adjustable Not adjustable Str./Rec.BGM LOW Not adjustable Not adjustable Str./Rec.PAUS OFF 1 to 3.5 (2.5)

Increments of 0.5Not adjustable OFF

ARTF OFF Not adjustable Not adjustable OFF

NOTEWhen in neonatal mode or pediatric mode with Basic Arrhythmia monitoring, bradycardia is a high heart rate alarm that is adjustable.


Respiration

Quick Reference Table - OCRG Setup

Quick Reference Table - OxyCRG Review Summary

OxyCRG Setup MenuMenu item Description Settings

Parameter 2 Displays a list of label choices for updating the sec-ond channel of the OCRG menu.

– SpO2– tpO2– tpO2*

Parameter 3 Displays a list of label choices for updating the third channel of the OCRG menu.

– RESP– etCO2– etCO2*

Timed Displays Time Base choices.

NOTE: Selecting Time Base displays the clinical password menu. The new OCRG Time Base takes effect after you enter the password.

– 3min– 6min

The OxyCRG Review Summary MenuMenu item Description SettingsHours Changes the time interval for data on the OCRG

Summary screen. Press knob to select the Hours button. Turn the rotary knob to select the time interval setting. Press the rotary knob again to display a new time interval.

– 1 hr– 2 hr– 4 hr– 6 hr– 12 hr


Non-Invasive Blood Pressure

Overview

The monitor can acquire and process non-invasive blood pressure (NBP) signals and display the results for neonatal, pediatric and adult patients. NBP accuracy was established using intra-arterial blood pressure monitoring as a reference (within the limits prescribed by the Association for Advancement of Medical Instrumentation, Electronic Automated Sphygmomanometers). Accuracy testing references used the femoral artery for adults, and the umbilical, brachial, radial or femoral arteries for pediatric and neonate patients. NBP measurements for accuracy testing occurred on the same limb. NBP effectiveness for pregnant and pre-eclamptic patients has not been established according to ISO 81060-2.

The accuracy is compromised with patients having dysrhythmias, arterial sclerosis, experiencing seizures, or any type of cardiac or vascular malformation which results in an abnormal arterial waveform. Blood pressure measurements are determined by the oscillometric method. Once the cuff has been inflated to occlude the blood flow through the patient’s limb, the cuff is deflated in a controlled manner. As the cuff pressure decreases, the oscillations increase in amplitude and then decrease as blood returns to normal flow. From this change in amplitude the mean arterial blood pressure can be directly determined and systolic (S) and diastolic (D) blood pressures derived.


NBP Cuff Diagram

A Cuff size indicators D Range labels

B Artery label E Label: This side to patient

C Index line

A B C

E D

NOTEThis 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.


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).

Venous Stasis

Software VF9.1 and higher supports venous stasis in adult mode only (with adult-based inflation pres-sures).

NBP hose connector

Kappa

Delta/Delta XL

NBP hose connector


Continuous Non-invasive Arterial Blood Pressure (CNAP) Pod

To connect CNAP pod and sensor cuff

1 Connect the sensor cuff (D) to the cuff controller (A).

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).

A

B

C

D

E

F

G

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

NOTEDuring CNAP measurements, the NBP Interval Time (5, 10, 15 min) is disabled and controlled by the Auto CNAP Relearn menu.


CNAP Calibration

Each time a CNAP measurement starts or the infla-tion pressure alternates between the dual finger cuffs, CNAP automatically calibrates. Calibration consists of a pulse determination phase followed by an NBP correlation measurement. During calibra-tion a triangular wave (for pod firmware version 2.14.14.) displays in the CNAP waveform area and then the message CNAP @ Calibrating displays

and the CNAP values are blank. After a successful NBP measurement, the CNAP waveform and CNAP values display.

Status Messages

Maintenance (CNAP)

Overview

This chapter describes the maintenance measures required to maintain the proper functioning of the medical device. Maintenance measures must be performed by the responsible personnel.

NOTEA “rectangular” or “square” waveform displays for previous firmware versions.

Message Cause RemedyCNAP @ Calibrat-ing

CNAP calibration is in progress. Wait until calibration is complete.

NOTECalibration 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.

WARNINGRisk of infection.

Users and service personnel can become in-fected with pathogenic germs.

Disinfect and clean the device or the device parts before any maintenance measures and also before returning the medical device for repair.


Definition of Maintenance Concepts

Concept Definition

WARNINGRisk of electric shock

Components that carry current are located un-der the cover. Do not remove the cover. Main-tenance measures must be performed by the responsible personnel. Dräger recommends DrägerService to perform these measures.

WARNINGIf the device is mechanically damaged, or if it is not working properly, do not use it. Contact your hospital's technical personnel. Never perform monitor service or maintenance activ-ities while actively monitoring a patient.

CAUTIONThis device must be inspected and serviced at regular intervals. A record must be kept on this preventive maintenance. We recommend obtain-ing a service contract with DrägerService through your vendor. For repairs we recommend that your contact DrägerService.

CAUTIONWhen servicing devices from Dräger, always use replacement parts that are qualified to Dräger standards. Dräger does not warrant or ensure the safe performance of third-party replacement parts for use with the devices.

CAUTIONIf 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.

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 Maintenance

Recurrent specified measures intended to maintain the functional condition of a medical device.

Repair Measures intended to restore the functional condition of a medical device after a device malfunction.


Inspection

Perform inspections at regular intervals and ob-serve the following specifications.

CNAP / Cuff Controller

Visual Inspection

Perform a visual inspection before every use and in accordance with your hospital's policy.

1 Make sure that the housing is not cracked or broken and there are no signs of spilled liquids or damage.

2 Inspect all accessories (for example, sensors and cables). Do not use if there are any signs of damage.

3 Examine all system cables, power plugs and discontinue use if there are any signs of dam-age.

4 Inspect all patient cables, leads and strain re-liefs for general condition. Make sure the con-nectors are properly engaged at each end.

Inspection/ Safety Check

Inspection and safety checks of devices must be performed according to suggested intervals.

Scope of inspection/safety checks for the CNAP Pod/ Cuff Controller

Safety checks are no substitute for preventive maintenance measures (including preventive re-placement of wear parts} as identified by the man-ufacturer. Perform safety checks at the indicated in-tervals.

1 Check accompanying documents:

– Instructions for use are available

2 Perform a functional test of the following fea-tures according to the instructions for use:

– CNAP pod

– Cuff Controller

– Perform device checks (for example calibra-tion of pod with cuff controller, sensor cuff, and NBP cuff)

– Check/Visual inspection

3 Check that the device combination is in good condition:

– All labels are complete and legible

– There is no visible damage

4 Use the instructions for use to check that all components and accessories needed to use the product are available.

5 Check the electrical safety requirements ac-cording to IEC62353.

Checks Interval Responsible personnelInspection/safety checks Every 2 years Service personnelMetrological checks Every 2 years Service personnel

WARNINGRisk of medical device failure.

If safety checks are not performed on a regu-lar basis, the proper operation of the medical device can be compromised. Perform Safety Checks at the indicated interval.


Metrological checks

If required by applicable regulations, the following measurement functions must be checked every two years by qualified DrägerService personnel:

– Body temperature

– Non-invasive blood pressure

Preventive Maintenance

The following table shows the preventive mainte-nance intervals:

Pulse Oximetry (SpO2)

WARNINGRisk of faulty components.

Device failure is possible due to wear or mate-rial fatigue of the components. To maintain proper operation of all components, this de-vice must undergo inspection and preventive maintenance at specified intervals.

WARNINGRisk of electric shock.

Before performing any maintenance work, dis-connect all electrical connectors from the power supply.

Component Interval Measure Responsible PersonnelCalibration of CNAP SmartPod

Every 2 years Calibrate Expert

Calibration of CNAP cuff controller

Every 2 years Calibrate Expert

Replacement of the air pump

Every 2 years Replace Expert

WARNINGA pulse oximeter should be considered an early warning device. If a trend towards pa-tient hypoxemia is observed, blood samples should be analyzed by laboratory instruments to completely understand the condition of the patient.

WARNINGThe pulsations from intra-aortic balloon sup-port can elevate the pulse rate. Verify the pulse rate of the patient against the heart rate.

WARNINGRisk of patient injury.If the SpO2 sensor is used in the presence of significant concentrations of dyshemoglo-bins, such as carboxyhemoglobin or methe-moglobin, measurement accuracy may be re-duced.Do not rely on measurement data if the SpO2 sensor is used under these conditions.


Quick Reference Table - SpO2 Setup

WARNINGIf the SpO2 sensor is used in the presence of elevated levels of bilirubin, measurement ac-curacy may be reduced.

Do not rely on measurement data if the SpO2 sensor is used under these conditions.

WARNINGIf the SpO2 sensor is used in the presence of intravascular dyes, such as methylene blue, measurement accuracy may be inaccurate.Do not rely on measurement data if the SpO2 sensor is used under these conditions.

WARNINGRisk of inaccurate data.In the presence of shock, low blood pressure, severe vasoconstriction, major anemia, hypo-thermia, arterial occlusion proximal to the sensor, and asystole, the pulse rate may be in-accurate.

WARNINGRisk of patient injury.High intrathoracic pressure, pressure on the thorax and other consecutive impairments of the venous flow can lead to venous pulsation and pulse signal failure.Do not position the SpO2 sensor where it might be affected in this way.

WARNINGTo reduce the hazard of burns during surgery, keep the sensor or transducer and their asso-ciated cables away from the surgical site, the electro-surgical unit return cathode, and the earth ground.

CAUTIONFor Masimo SET pod, after connection of the sen-sor, observe monitor for any messages if the sen-sor does not light up. If the sensor LED does not light up, replace sensor and/or intermediate ca-ble.

CAUTIONRefer to the “Pulse Oximetry (SpO2)” chapter in the Infinity Delta Series Instructions for Use for Software VF9 for additional precautions regarding safe device operation.

CAUTIONDo not immerse the sensor or patient cable in any liquid. Moisture may present a safety risk.

NOTEWhen in neonatal mode or pediatric mode with Basic Arrhythmia monitoring, bradycardia is a high heart rate alarm that is adjustable.

Menu item Description SettingsSpO2 Alarm Accesses SpO2 alarms

on the Alarm Limits table.– SpO2 OxiSure = 20 – 100% in increments of 1%– 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%


New Status Message

The following status message applies to any moni-tor using a Masimo SET pod.

Dräger Mainstream etCO2 Monitoring

Application

Intended Use

The Dräger Mainstream CO2 module, when con-nected to a monitor, allows the monitor to measure and display mainstream etCO2 (end-tidal CO2), iCO2 (inspired CO2) and RRc (Respiration Rate) for neonate, pediatric and adult patients. Respirato-ry phases are determined from excursion of the CO2 data through a threshold which is adaptively calculated from the CO2 curve. The maximum CO2 value during the expiratory phase is taken as end-tidal CO2 (etCO2), immediately shown after each breath. The Dräger Mainstream CO2 module can-not be used simultaneously with Scio Four mod-ules.

Precautions

Message Possible Cause Suggested ActionReplace SpO2 Sensor/Cable The sensor or the cable is ex-

pired or defective.Replace the sensor or the cable.

WARNINGFor premature infants, do not carry out CO2 measurements because the CO2 cuvette sig-nificantly increases the dead space.

NOTEThe Dräger Mainstream CO2 module is compati-ble with Delta and Delta XL monitors. The Dräger Mainstream CO2 module is not compatible with Kappa.

WARNINGRisk of misinterpretationMisdiagnosis or misinterpretation of the mea-sured values or other parameters can endan-ger the patient. Do not make therapeutic deci-sions based solely on individual measured values and monitoring parameters. Therapeu-tic decisions must be made solely by qualified users.

WARNINGRisk of patient safetyThe etCO2 related information displayed is in-tended to be used by trained and authorized health care professionals only.

WARNINGRisk of inaccurate gas measurement values

During warm-up, reported values may not be accurate. Wait until the Dräger Mainstream CO2 sensor has completed initialization and warm-up.

WARNINGThe 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.


WARNINGRRc apnea alarms are NOT reported if the set-ting RRc Apnea Time is set to OFF in the etCO2 setup menu and the RRc* alarm feature is deactivated. To generate RRc* apnea alarms, activate the RRc* alarms and select an RRc* apnea time.

WARNINGTo minimize the risk of patient strangulation, carefully position and secure sensor cables.

WARNINGPatient monitors that measure CO2, anesthet-ic agents, and/or respiratory mechanics are not intended to be used as an apnea monitor and/or recording device. While these products provide an apnea alarm, that alarm condition is initiated based on the elapsed time since the last breath was detected. Clinical diagno-sis of a true apneic event, however, requires multiple physiological signals.

WARNINGIn an ambient temperature of 104 degrees F (40 degrees C), the CO2 mainstream sensor reaches a surface temperature of 110 degrees F (43 degrees C).

WARNINGDo not use the CO2 mainstream sensor in an explosive or oxygen-enriched environment (atmosphere) (100% oxygen is allowed in the measuring cuvette). Fire hazard!

WARNINGRisk 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).

WARNINGDo not use any explosive anesthetic agents, e.g., ether, or cyclopropane. Fire hazard!

CAUTIONLeaks in the breathing circuit (for example, an un-cuffed endotracheal tube or a damaged cuvette) may significantly affect CO2* measurement val-ues.

CAUTIONTo avoid accidental disconnections, do not apply excessive tension to any sensor cable.

CAUTIONTo prevent leakage, make sure the cuvette is firm-ly connected to the breathing circuit.

CAUTIONCheck the CO2 mainstream sensor and measure-ing cuvette for damage before use. A damaged CO2 sensor may impair electrical isolation or may introduce debris into the breathing circuit.

CAUTIONOnly use the mainstream CO2 sensor with the ap-proved CO2 measuring cuvettes for adult or pedi-atric applications. See the “Approved options and accessories” section. The measuring function may otherwise be inaccurate.

NOTEIn this chapter, all Infinity Delta Series patient monitors are referred to as "patient monitor".


Connection

Hardware - Module Connection

Connection ports are marked on the front of the Dräger mainstream CO2 module. Use the diagram below as a guide when connecting the module, ca-bles, and accessories to the monitor.

Slide the Dräger mainstream CO2 module into the slot on the rear of the monitor until it rests securely.

A

BC

D E

A Dräger mainstream CO2 module D Connection port for external SpO2 pod

B Infinity MCable - CO2 mainstream sensor cable connection

E External SpO2 pod

C Connection port for the CO2 mod-ule to monitor


Connecting the Sensor

Before you connect any CO2 hardware, make sure the cuvette setting of the monitor matches the cu-vette in use. For example, the Delta must be config-ured for a disposable cuvette if a disposable cu-vette is being used. Not aligning the configuration setting with the cuvette type compromises the dis-played CO2 value.

To connect the sensor

1 Connect the Dräger mainstream CO2 sensor cable into the Dräger mainstream CO2 module input port (as depicted by B on the hardware – module connection diagram).

2 Select a suitable mainstream cuvette (H) whose windows are clean and dry (replace the cuvette if necessary).

3 Insert the cuvette (H) between the endotracheal tube adapter (I) and the ventilator (G).

4 Snap the Dräger mainstream CO2 sensor (F) firmly into the cuvette (H) and make sure that the cable is directed away from the patient.

CAUTIONThe cuvette windows of the reusable cuvette have different optical properties to the cuvette windows of the disposable cuvette. Therefore, select the cuvette type correctly. Otherwise the zero point shifts by up to 8 mmHg CO2 (1.1 kPa CO2).

F

G

H

I

F Dräger mainstream CO2 sensor H Cuvette

G Y-piece I Tracheal tube adapter

CAUTIONAlways use the mainstream CO2 measuring cu-vettes with the windows in an upright position. Otherwise condensation deposits from the breathing system may collect, which could impair proper function.


Getting Started

Patient Preparation for Dräger Mainstream CO2 Monitoring

The following tips provide optimal monitoring re-sults but must never replace hospital-approved practices or manufacturer’s recommendations.

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-ing administered in the etCO2 parameter menu. Make sure to adjust the atmospheric pressure to the actual value. Failure to compensate for supple-mental gases results in inaccurate measurement values.

When switching cuvette types (from reusable to disposable or adult to pediatric, or vice versa) you do not have to rezero a Dräger sensor. If the sensor window is clean and the correct sensor type is cho-sen in the etCO2* parameter menu (under Cuvette Type), only zero a Dräger sensor when the mea-surement value is suspect. Otherwise, perform ze-roing once a day or when prompted to rezero.

Initialization

Upon start-up, the sensor goes through a warm-up period (status message \211 CO2* Warming Up appears). During this time (approximately 30 sec-onds), concentrations for CO2 may not be avail-able.

Display Features

etCO2* Monitoring

The etCO2* waveform displays the instantaneous CO2 concentration. The etCO2* parameter box dis-plays the following parameters:

– End-tidal CO2 (etCO2*) — The level of CO2 in the airway at the end of expiration.

– Inspired CO2 (iCO2*) — The level of CO2 in the airway during the inspiration phase.

– Respiration Rate (RRc*) — The patient’s respiration rate, derived from the etCO2* signal by calculating an average rate over the two most recent breaths.CAUTION

The cuvette windows of the reusable cuvette have different optical properties to the cuvette windows of the disposable cuvette. Therefore, select the cuvette type correctly, otherwise the zero point shifts by up to 8 mmHg CO2.

NOTEThe parameter labels etCO2, iCO2, and RRc are marked by an asterisk (*) to distinguish them from CO2-related parameters provided by the Infinity etCO2 Microstream SmartPod.


etCO2* Parameter Box

Typical etCO2* parameter box displays are shown below.

etCO2* Setup

To access the etCO2* setup menu

Click on the etCO2* parameter box

or

1 Press the Menu fixed key.

2 Click on Patient Setup.

3 Click on Parameters to display a list of avail-able parameters.

4 Click on etCO2*.

Quick Reference Table - etCO2* Setup

Click on the following items to execute etCO2* set-up functions:

A etCO2* (end-tidal CO2) label and value

B etCO2* alarm limits

C iCO2* (inspired CO2) label and value

D iCO2* alarm limit (upper limit only)

E Respiration rate label and value

F Respiration rate alarm limits

A

B

C

DE

F

NOTEIf alarms are disabled, crossed-out triangle icons appear next to the corresponding parameter val-ues.

NOTEThe patient monitor does not alarm for etCO2* vi-olations until it has established a valid respiratory rate.

Menu Item Description SettingsDevice Describes what CO2* device is connected and

displays parameters on the monitor.

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.)

– CO2*– SCIO/MIB– None


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 Speed

Sets the respiratory waveform sweep speed on the screen’s display.

6.25, 12.5, 25, 50 mm/s (6.25 mm/s default)

Atm. Pressure Sets the compensation for ambient atmospheric pressure.

540-800 mmHg in increments of 1 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 adapters

– Disposable– Reusable (default)

Gas Compensa-tion

Determines gas percentages for inspiratory and expiratory breathing.

– Air (default)– N2O/O2 (in OR mode only)– O2>60%– HeliOx

RRc* Apnea Time

Sets the time that the monitor waits before re-porting a cessation of breathing as an apnea event.

OFF, 10, 15, 20, 25, 30 s(Adult: OFF default)(Pediatric/neonatal: 15 s default)

Apnea Archive Stores and/or records an alarm event automati-cally for apnea. You can later review stored alarms on the Event Recall screen.

OFF, Record, Store (default), Str./Rec.

Calibration Check

Checks the calibration of the CO2* sensor with a test filter. The monitor will report whether or not the calibration check has passed or failed.

NOTEThe 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

(Only available if a Dräger Main-stream CO2 mod-ule is connected.)

Zeroes the CO2* sensor. The CO2* sensor stores a new zero point for CO2* mea-surements.

NOTEThe sensor must be removed from the cuvette before zeroing. The sensor is zeroed 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.

Menu Item Description Settings


Smart Apnea

In OR mode only, the monitor will automatically en-gage the Smart Apnea feature for RRc* apnea alarms if RRc* Apnea Time is set to a selection

other than OFF in the etCO2* parameter menu.The Smart Alarm feature will escalate an apnea alarm in the following manner:

To illustrate, if RRc* Apnea Time is set to 10 sec-onds and if an apnea alarm condition is present for 10 seconds, an attention tone annunciates and the alarm message RRc* @ Apnea displays. If the ap-nea alarm condition continues to be present for 20 seconds, another attention tone will annunciate and the alarm message remains on the monitor. At 30 seconds, a medium alarm will annunciate. At 60 seconds a high alarm will annunciate.

Multiple CO2* Devices

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 etCO2* parameter menu appears. You can select the desired CO2* device (as described in the Quick Reference Table). Or, you can physically discon-nect the undesired CO2* device.

A label in the upper left corner of the etCO2* wave-form identifies the CO2* device that is providing in-formation to the user.

Capnograms

The monitor also displays an instantaneous CO2 waveform or capnogram.

RRc* Apnea Time in Seconds

Alarm Priority Alarm Message Displayed Alarm History

RRc* apnea time None; Single attention tone RRc* @ Apnea NoRRc* apnea time * 2 None; Single attention tone RRc* @ Apnea NoRRc* apnea time * 3 Medium RRc* @ Apnea YesRRc* apnea time * 6 High RRc* @ Apnea Yes

NOTECO2* devices include the Dräger mainstream CO2 module, Scio Four modules, or a device with etCO2* capabilities (e.g., ventilator, anesthesia machine) connected through MIB.

NOTEIf the monitor detects multiple CO2* devices, the first device that was connected to the monitor re-tains priority until the user selects a different CO2* device in the etCO2* parameter menu or the un-desired CO2* is physically disconnected from the monitor.

A Expiratory or alveolar plateau (level of CO2 in lungs ceases to increase signifi-cantly)

B End-tidal concentration point (end of expi-ration phase, where CO2 is measured)

C Onset of inspiration phaseD Onset of expiratory phaseE Baseline during inspiration

AB

C

DE


Zeroing

Perform the zeroing process once a day or when prompted to zero.

The zeroing operation is performed in ambient air with a clean Dräger mainstream CO2 sensor that is removed from the cuvette.

1 Remove the Dräger mainstream CO2 sensor from the cuvette.

2 Select CO2* Zero under the etCO2* parameter menu. The monitor performs the zeroing opera-tion and displays a message that the CO2 zero-ing is in progress. Waveforms flatline and pa-rameter box values blank from the screen during this cycle.

3 Fit the Dräger mainstream CO2 sensor onto the cuvette.

If zero was successful, the monitor will display the message CO2* Zero Accepted after approximate-ly 30 seconds. If zero was unsuccessful, the moni-tor will display the message CO2* Zero Failed. Re-peat the zeroing operation. If the zero remains un-successful, check whether the sensor is contami-nated, clean it if necessary, and re-zero. If the zero still remains unsuccessful, the sensor may be de-fective requiring replacement.

Checking Calibration of the Dräger Mainstream CO2 Sensor with Test Filter

Perform the calibration check of the Dräger mainstream CO2 sensor with test filter at inter-vals of one month.

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.

Starting the Calibration Check of the Dräger Mainstream CO2 Sensor with Test Filter

1 Remove the sensor from the cuvette and con-nect it to the test filter on the sensor cable.

2 Access the etCO2* parameter menu.

3 Select Calibration Check.The monitor starts the check and displays the progress and result of the check in the message area.

If the check was successful

The monitor displays the message, Filter Check Successful. The test value is within the permissi-ble tolerance.

Fit the Dräger mainstream CO2 sensor back on the cuvette.

If the check was not successful

The monitor displays the message, Filter Check Failed. The test value is outside the permissible tol-erance.

Contact DrägerService.

Troubleshooting

If an alarm occurs, the table below helps to quickly identify causes and remedies. The possible causes and remedial measures should be consulted in the order in which they are listed until the alarm is re-solved.


The following table lists the alarm messages in or-der of priority.

Alarm Priority Alarm Cause Remedy

Medium iCO2* > # Leakage in the breathing system.

Exchange breathing sys-tem.

lnspired CO2 concentration has exceeded the upper alarm limit.

Check ventilation.

Gas measurement is inaccurate due to high respiratory rate.

Adjust alarm limits if necessary.

Large dead space. Check ventilation settings.

Medium etCO2* > # End-tidal CO2 concentration has exceeded the upper alarm limit.

Check ventilation.

Medium etCO2* < # End-tidal CO2 concentration has fallen below the lower alarm limit.

Check ventilation.

Medium RRc* > # The patient is breathing at a high respiratory rate.

• Check patient condition.• Check ventilation

settings or spontaneous respiratory rate.

RRc* has exceeded the upper alarm limit.

Check ventilation settings.

Medium RRc* < # RRc* has fallen below the lower alarm limit.

• Check patient condition.• Check ventilation

settings.

Medium (escalates in OR mode - see Smart Apnea section)

RRc* @ Apnea No breathing or ventilation. • Start manual ventilation!• Check ventilation

settings.• 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 Range (High)

Inspiratory gas concentration has exceeded the upper measuring range.

Check ventilation.

Medium iCO2* @ Out of Range (Low)

Inspiratory gas concentration has fallen below the lower measurement range.

Check zero.

Medium etCO2* @ Out Of Range (High)

Expiratory gas concentration has exceeded the upper measuring range.

Check ventilation.


Medium etCO2* @ Out of Range (Low)

Expiratory gas concentration has fallen below the lower measuring range.

• Check ventilation.• Check zero.

Medium RRc* @ Out Of Range (High)

Respiration rate has exceeded the upper measuring range.

Check ventilation or spontaneous respiration rate.

Medium CO2* Check Cuvette Type

A disposable cuvette has been selected on the monitor but a reusable cuvette has been inserted into the breathing apparatus (or vice versa).

Ensure the correct cuvette is used and that the cuvette selected on the monitor is correct.

If cuvette used matches that selected on the monitor, the zero may have drifted.

Check zero.

Medium CO2* Window Occluded

Window is contaminated or occluded

Ensure window is clean.

Low CO2* Sensor Too Warm

Dräger mainstream CO2 sensor too warm as a result of the ambient clinical environment.

• Correct ambient clinical environment.

• If the problem persists, call DrägerService.

Low CO2* Disconnected Dräger mainstream CO2 sensor unplugged and/or module disconnected.

• Check sensor and module connections.


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.


Failure of the entire Dräger mainstream CO2 module.

Call DrägerService.

Alarm Priority Alarm Cause Remedy


Status Messages

MultiGas Monitoring

SCIO MultiGas

1 MAC

1 MAC is the anesthetic gas concentration in the blood at 760 mmHg (1013 hPa), at which 50% of patients no longer respond to a skin incision with movement. The integrated MAC algorithm is based on the MAC values as indicated on the list. These values are merely guideline values. It is the infor-mation on the slip accompanying the anesthetic agents which is binding.

1 MAC corresponds to:

Message Condition Suggested actionCO2* Please Zero Zero has drifted Perform a zeroing operationCO2* Reduced Ac-curacy

Measurement values have reduced accu-racy due to warm-up or because the Dräger mainstream CO2 sensor is begin-ning to become too warm.

NOTEMeasured parameter labels will display but will be followed by a “?”.

NOTEAlarm history displays CO2* Reduced Ac-curacy. When this condition is removed, the alarm history displays CO2* Reduced Accuracy Ended.

NOTEParameter box (Pbox) question marks (?) are not transmitted/displayed over the net-work. They only appear in Pboxes.

• Wait until the warm-up phase has ended before relying on the displayed etCO2* values for clinical evaluation.

• Correct ambient clinical environment.


Duplicate Device Connected

Multiple CO2* devices are connected. • Select desired CO2* device in the etCO2* parameter menu.

• Disconnect the unwanted CO2* device.

Agent in 100% O2Desflurane 6.0 Vol%Enflurane 1.7 Vol%Halothane 0.77 Vol%Isoflurane 1.15 Vol%Nitrous oxide 105 Vol%Sevoflurane 2.1 Vol%


The MAC values are dependent on the age of the patient. The values indicated in the table relate to an age of 40 years.

The Delta series monitor automatically adjusts the MAC calculation according to the ambient pressure measured by the gas analyzer.

Once the monitor has detected an agent, the pa-rameter box shows a MAC value.

For gas mixtures, the respective multiples for N2O and anesthetic agents are added according to the following equation:

System Compatibility

MAC is not supported by the network.

Troubleshooting

The following table describes alarms inalphabetical order by alarm message:

Alarm priority Alarm Cause RemedyLow 2 Mixed Agents A second anesthetic

agent has been detected.– Wait for the transition phase

to end after changing anes-thetic agents.

– Check vaporizer filling level.– Flush system if necessary.– Check fresh gas settings.

Medium 3 Mixed Agents

NOTEThe simultaneous presence of 3 agents cannot always be identified.

A mixture of more than two anesthetic agents has been detected.

– Wait for the transition phase to end after changing anes-thetic agents.

– Check vaporizer filling level.– Flush system if necessary.– Check fresh gas settings.

Medium Inspired MAC High Inspiratory anesthetic gas concentration exceeds 3 MAC for a period of 30 or more seconds.

– Check vaporizer and fresh gas setting.

Low MultiGas Module Disconnected

Gas analyzer is discon-nected.

– Check cable connections.– If the problem persists, call

DrägerService.


Status Messages

Message Condition Suggested actionDuplicate Device Connected

Multiple CO2* devices are con-nected.

– Select the desired CO2* device in the et-CO2* Parameter menu.

– Disconnect the unwanted, duplicate CO2* device.

MultiGas Reduced Accuracy

Warm-up phase in progress

NOTES– Measured values will display

but followed by a "?"– Alarm history displays Multi-

Gas Reduced Accuracy. 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.

– Wait until the warm-up phase has ended before relying on the displayed MultiGas values for clinical evaluation.

– If Auto Zero Delay has been selected, al-low the auto zero to occur.

– If the problem persists, call DrägerSer-vice.

MultiGas Zero Ac-cepted

The zeroing cycle was success-ful.

No action is required.


Neuromuscular Transmission (NMT) Monitoring

Precautions

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

WARNINGTo 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.


213 5

4

6 7

8

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 separatetransducer 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.


To set up the PiCCO Pod

1

2

3

4

5

6

57

8

9

10

11

12

1

1 Pulsion CVP catheter1 7 Pulsion blood pressure transducer1

2 Pulsion injectate temperature sensor housing1

8 PodCom connection to Delta series monitor

3 p-CO thermistor cable 9 10-pin transducer adapter cable4 p-CO intermediate cable 10 Pulsion arterial thermodilution catheters1

5 Infinity PiCCO pod 11 p-CO catheter cable6 CO connector 12 Pressure transducer interface cable1Catheters 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.


1 Insert a central venous catheter (CVC) into the patient.

2 Prepare a pressure monitoring kit for arterial pressure monitoring. Fill the transducer kit care-fully using the flush clip. Air bubbles in the pres-sure lines or in the transducer will influence the transmission and can cause measuring errors.

3 Insert an arterial thermodilution catheter into a suitable artery (femoral,brachial or axillary ar-tery) of the patient. Take care that all air is evac-uated from the blood pressure lumen.

4 Connect the pressure line of the monitoring kit to the lumen of the thermodilution catheter.

5 Fill the injectate temperature sensor housing, enclosed in the pressure monitoring kit and con-nect it to the distal lumen of the central venous line.

6 Connect the p-CO thermistor cable to the p-CO intermediate cable.

7 Plug the p-CO intermediate cable into the port labeled “CO” on the PiCCO pod.

8 Connect the “Injectate temperature sensor housing” to the p-CO thermistor cable.

9 Slide the Arterial Pressure transducer into a slot on the front of the transducer plate located be-neath the PiCCO pod. Make sure the pressure label is ART on the monitor.

10 Slide the Central Venous Pressure transducer into a different slot. Make sure the pressure la-bel is CVP on the monitor.

11 Connect the PiCCO catheter with the blood pressure transducer.

12 Use the 10-pin cable to connect the blood pres-sure transducer to the Delta/Delta XL/Kappa Delta series monitor.

13 If you have not already done so, enter the pa-tient specific input parameters (height and weight) in the Patient Admit menu.

14 A zero adjustment of the pressure transducer is now necessary. The following table outlines ze-roing procedures:

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 transducer you want to zero (ART, CVP, etc.). The parameter setup menu appears.

NOTE: You can also access the parameter menu as follows:

1) Press the Menu fixed key to display the main menu.

2) Click on Patient Setup.3) Click on Parameters.4) Scroll to the desired pressure parameter and click.

3(b). Press the key on the hemodynamic pod/MPod to zero all pressures whose transducers are open to air.WARNING: Do not use the ‘Smart Zero’ function if any pressure waveform is flat (nearly static). Only use the ‘Smart Zero’ function when all the stopcocks are opened to air.NOTE: If you use this step, 3(b), and are unable to zero a particular IBP with the key, use the associated parameter box as described in 3(a). This method can be more effective.4. Click on Zero.

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.


15 Press the C.O. Start fixed key on the front of the PiCCO pod or p-CO Start in the PiCCO main selection. A p-CO averaging screen appears on the screen. If you do not see a blood tempera-ture baseline, exit the screen and repeat this step.

16 Inject the bolus solution into the patient’s blood-stream only after you see the READY message. A thermodilution curve appears, displaying the change in blood temperature and a p-CO value is computed.

17 Repeat step 15 to take an additional measure-ment, making sure you wait for the READY message. If a temperature drop is not detected within four minutes, the Averaging screen clos-es, and the current p-CO values will be aver-aged and saved. You must repeat steps 15 and 16 if additional p-CO measurements are neces-sary.

Cleaning and Disinfecting

IBP - Infinity PiCCO Pod

Agents tested by Dräger and shown to have no harmful effect at the time of testing on the materials utilized in the Infinity PiCCO Pod include: – Isopropyl alcohol 40%

Higher concentrations could damage:– Compliance™; this cleaning agent may discolor

soft plastic material– Sporox II– Dismozon pur

To clean the Infinity PiCCO Pod

1 Disconnect the Infinity PiCCO pod from the bedside monitor.

2 Clean the Infinity PiCCO pod with a gauze pad moistened with soapy water or with an ap-proved cleaning agent.

3 Dry thoroughly with a lint-free cloth.

To disinfect the Infinity PiCCO Pod

1 Disconnect the Infinity PiCCO pod from the bedside monitor.

2 Disinfect the Infinity PiCCO pod with a gauze pad moistened with diluted alcohol.


NOTEMake sure all patient connections are secure and valid blood temperature and injectate temperature readings are present before initiating a p-CO measurement.

NOTE– In order to avoid disruption of p-CO thermodi-

lution measurement, avoid connecting or dis-connecting any cables or changing any menus when measurements are in progress.

– During a measurement, if p-IT or p-BT read-ings become invalid or go out of range, the av-eraging screen will disappear.

NOTEIf the READY message fails to appear or appears only intermittently, the blood temperature may be unstable. Check that all connections are correct and that the blood temperature is stable and valid and repeat step 15.

CAUTIONDo not autoclave the Infinity PiCCO Pod.

CAUTIONIf using alcohol, it should only be a 40% diluted solution.


etCO2

Dräger Mainstream CO2 Module, Sensor, and Cuvettes

Mainstream Module

To clean the Mainstream Module

1 Disconnect the sensor cable (SpO2 cable, if us-ing) from the Dräger etCO2 mainstream mod-ule.

2 Wipe the module surfaces with a cloth moist-ened with a soap solution.


To disinfect the Mainstream Module

1 Disconnect the sensor cable (including the SpO2 cable, if using) from the Dräger etCO2 Mainstream Module.

2 Wipe the module surfaces with a gauze moist-ened with one of the following:

– A 1:3 solution of alcohol should be used

– A 1:10 solution of sodium hypochlorite (household bleach)


Mainstream Sensor and Cuvettes

For cleaning and disinfecting instructions for the sensor and reusable cuvettes, refer to the Dräger Infinity MCable – Mainstream CO2 IFU.

WARNINGTo reduce the risk of infection, remember that the disposable cuvettes are for single patient use only and cannot be sterilized.


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.

Immunity against IEC 60601-1-2 Test Level: Compliance level (of this device: Electromagnetic Environment:

Electrostatic discharge, ESD (IEC 61000-4-2)

Contact discharge: ±6 kVair discharge: ±8 kV

±6 kV±8 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% so that electrostatic charges are at suitable levels.

Electrical fast transients / bursts (IEC 61000-4-4)

Power supply lines: ±2 kV longer input / output lines: ±1 kV

±2 kV

±1 kV

Mains power quality should be that of a typical commercial or hospital environment.

Surges on AC mains lines(IEC 61000-4-5)

Common mode: ±2 kVDifferential mode: ±1 kV

±2 kV±1 kV

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency magnetic field 50/60 Hz(IEC 61000-4-8)

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Voltage dips and short interruptions on AC mains input lines(IEC 61000-4-11)

Dip >95 %, 0.5 periodsDip 60 %, 5 periodsDip 30 %, 25 periodsDip >95 %, 5 seconds

>95 %, 0.5 per.60 %, 5 per.30 %, 25 per.>95 %, 5 sec.

Mains power quality should be that of a typical commercial or hospital environment. If the monitor’s user requires continued 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:


System Components

Delta/Delta XL base unit

Immunity test IEC 60601 Test Level: Compliance Level:

Recommended Separation Distance:

Conducted RFrf coupled into lines(IEC 61000-4-6)

150 kHz to 80 MHz RMSSee note 3

Radiated rf(IEC 61000-4-3)

80 MHz to 800 GHz

800 MHz to 2.5 GHz

3 V/m

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.

Electrical specificationsAlarm tone sound pressure L(A) alarm tone sequence

Free field measurements (complying with ISO 3744) IEC/Infin-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.


Monitoring Accessories

Infinity PiCCO Pod

Mainstream CO2 Module and Sensor

Physical attributesSize (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 monitorDegree of protection against ingress of water

IPX1 (protected against harmful effects of dripping water) per IEC 60529

Electrical specificationsPower source Powered directly from the monitorProtection against electric shock

Type CF

Mode of operation ContinuousDefibrillation protection YesEnvironmental requirementsTemperature 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)

Physical specificationsSize (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 portCuvette internal volume (dead space)

Adult 6.7 cm3 (0.41 in3)Pediatric 4.6 cm3 (0.28 in3)

Cuvette effective dead space volume

Adult 4.3 cm3 (0.26 in3)Pediatric 1.9 cm3 (0.12 in3)

Protection against liquid in-gress

Module: IPX1 (protected against harmful effects of dripping water) per IEC 60529Sensor: IP64 (dust-tight, protected against splashing water) per IEC 60529

Electrical specificationsPower source Powered directly from monitor


Invasive Blood Pressure

Monitoring Specifications

ECG

Mode of operation ContinuousProtection against electric shock

Sensor: Type BF

Defibrillator protection YesEnvironmental 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)

Physical specifications

Frequency ranges DC to 8, 16 or 32 Hz ± 10% (user selectable)Accuracy ±1 mmHg or ±1 % exclusive of transducer (whichever is greater)

WARNINGThe following parameters are not monitored in neonatal mode: arrhythmia, cardiac output, ST, and all MultiGas parameters.

Description ValueV/s pacer detected 3.18 V/s


Respiration

Pulse Contour Cardiac Output (PiCCO)

Description ValueMeasurement range: Range: 0 - 154 breaths per min

Additional technical dataMeasurement method PCCI Continuous Pulse Contour Analysis

PCCO Continuous Pulse Contour Analysisp-SVI Continuous Pulse Contour AnalysisSVV Continuous Pulse Contour Analysisp-SVR Continuous Pulse Contour Analysisp-SVRI Continuous Pulse Contour AnalysisdPmax Continuous Pulse Contour AnalysisGEF Transpulmonary Thermodilutionp-CO Transpulmonary ThermodilutionGEDV Transpulmonary ThermodilutionGEDVI Transpulmonary ThermodilutionEVLW Transpulmonary ThermodilutionEVLWI Transpulmonary ThermodilutionPVPI Transpulmonary Thermodilution

Display resolution PCCI 0.01 L/min/m2

PCCO 0.01 L/minp-SVI 1 ml/m2

SVV 1%p-SVR 10 dyn.sec. cm-5

p-SVRI 10 dyn.sec. cm-5/m2

dPmax 1 mmHg/sGEF 1%p-CO 0.01 L/minGEDV 1 mlGEDVI 1 ml/m2

EVLW 1 mlEVLWI 1 ml/kgPVPI 0.1p-BT 0.1 ºC (1 ºF)

Measurement range PCCI 0.01 to 15 L/min/m2

PCCO 0.25 to 25 l/mp-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/sGEF 1 to 99%p-CO 0.25 to 25 L/minGEDV 40 to 4800 mlGEDVI 80 to 2400 ml/m2

EVLW 10 to 5000 mlEVLWI 0 to 50 ml/kgPVPI 0.1 to 10p-BT 25 ºC to 43 ºC (77 ºF to 109 ºF)


Non-Invasive Blood Pressure (NBP)

Accuracy PCCI Not applicablePCCO Coefficient of variation ≤ 3%p-SVI Not applicableSVV Not applicablep-SVR Not applicablep-SVRI Not applicabledPmax Not applicableGEF Not applicablep-CO Coefficient of variation ≤ 1%GEDV Coefficient of variation ≤ 2%GEDVI Not applicableEVLW Not applicableEVLWI Not applicablePVPI Not applicable

Zero balance range ±200mmHg

Additional technical data

Pressure measurement range(Adult - 270 mmHg, 36.0 kPa)

Systolic NBP: 30 to 250 mmHg (4.0 to 33.3 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(Pediatric - 180 mmHg, 24.0 kPa)


Pressure measurement range(Neonatal - 140 mmHg, 18.7 kPa)


Connections Quick-release hose connector with single airwayDefault 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-surement (±10 mmHg)

Adult (270): Previous NBPSYS + 25 mmHg (+ 3.3 kPa)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 secPediatric (180): 2 min ±1 secNeonatal (140): 90 sec ±1 sec


Maximum measurement time including a retry

Adult (270): 3 min ±1 secPediatric (180): 3 min ±1 secNeonatal (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)


Pulse Oximetry (Masimo SET SpO2 via Pod)

Description ValueMeasurement range %SpO2: 1 to 100%

Pulse rate: 25 to 239 /minPerfusion: 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 specified70 to 100%:

Adults, pediatrics ±2 Neonates ±3

Saturation (%SpO2) - During motion conditions:(3, 4)0 to 69% not specified70 to 100%:

Adults, pediatrics(3) ±3 Neonates(4) ±3

Pulse Rate (bpm) - During no motion conditions:(2)

Adults, pediatrics, neonates bpm ±3Pulse 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.


Pulse oximetry (Nellcor Oximax SpO2 via pod) Parameter display Saturation (%SpO2), pulse rateMeasurement range %SpO2: 1 - 100%

Pulse rate:25 - 239 /min

Measurement accuracy, adult mode (1, 2, 4):Saturation (%SpO2):0 to 60% not specified60 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-FASTSC-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


CO2 Concentrations Via Mainstream CO2 Module and Sensor

Description ValueParameter display etCO2*, iCO2*, RRc*Measuring principle Dual wavelength infrared absorptionMeasurement 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/minZeroing 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: YesPediatric: Yes

Total system response time <200 ms (rise time plus delay time)Rise time <35 ms


How Performance is affected by Barometric Pressure

:

Delay time <165 msTime until availability <10 sData sample rate Sensor: 20 msDisplay update period 2 sTime 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-ty/condensate

The cuvette windows are indirectly heated through the 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 pressures up to 10 kPa (100 cmH2O)

No effect

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.

Description Value

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 tocorrect Atm pressure

Correction Factors for Atmospheric Pressure

Atm. pr.106.3 kPa

Atm. pr.101.3 kPa

Atm. pr.96.3 kPa

Atm. pr.91.3 kPa

Atm. pr.86.3 kPa

Atm. pr.81.3 kPa

1 kPa (7.5 mmHg) 0.981 1 1.020 1.042 1.066 1.0935 kPa (37.5 mmHg) 0.969 1 1.033 1.069 1.0109 1.15310 kPa (75.0 mmHg) 0.969 1 1.033 1.070 1.110 1.155NOTE: This table is applicable to the Gas Compensation of Air.


How performance is affected by interfering gases and vapors

NOTERegarding 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% 0.02Enflurane, 5 Vol% 0.03Isoflurane, 5 Vol% 0.02Sevoflurane, 5 Vol% 0.02Desflurane, 20 Vol% 0.00Ethanol, 4 % 0.00Isopropanol, 1 Vol% 0.00Acetone, 1 % 0.00Methane, 3 Vol% < 0.02NO, 100 ppm 0.01NO2, 50 ppm 0.00CO, 4 Vol% 0.00Freon R21, 100 Vol.% 0.07Freon R134a, 100 Vol.% 0.19Water vapor, 37 °C saturated 0.01NOTE: 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.


Approved Options and Accessories

Temperature probe covers

ECG leads

Standard ECG Lead Sets (Single Pin Version - for Direct Connection to MultiMed Plus and Mul-tiMed Plus OR)

Standard ECG Lead Sets (Dual Pin Version - for Direct Connection to MultiMed 5/6/12)

NOTEAll 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.

7014616 Core temperature probe covers, 20 cm, 10 pcs (contains latex)MS40243 Core temperature probe covers, 20 cm, 100 pcs (latex-free)

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)

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)


Invasive Blood Pressure (IBP)

IBP accessories

Pulse Oximeter (SpO2)

LNCS Adhesive SpO2 Sensors

LNCS Adhesive Trauma Sensors

5196998 Hemo pod adapter, Abbott/Medex/(Transtar) (One for each Hemo2 and two for each He-mo4/HemoMed pod)

NOTEFor Masimo sensors, unique part numbers for USA and Japan apply.

NOTEAlways refer to the Directions for Use accompa-nying the Masimo patient accessories.

NOTELNCS intermediate cables are designed to last approximately 17,000 hours while actively moni-toring SpO2 (for example 4 years if monitoring oc-curs 12 hours a day). This duration is monitored by a chip inside the cable.

ROW PN USA PN Japan PN DescriptionMP00790 MP03011 MP03089 Masimo SpO2-Sen LNCS Adtx Bx20MP00793 MP03012 MP03090 Masimo SpO2-Sen LNCS Pdtx Bx20MP00791 MP03013 MP03091 Masimo SpO2-Sen LNCS Inf Bx20MP00792 MP03014 MP03092 Masimo SpO2-Sen LNCS Neo Bx20MP00794 MP03015 MP03093 Masimo SpO2-Sen LNCS NeoPt Bx20

ROW PN USA PN Japan PN DescriptionMP03191 MP03016 MP03094 Masimo TraumaSen LNCS Adt Bx20MP03192 MP03017 MP03095 Masimo TraumaSen LNCS Neo Bx20MP03193 MP03018 MP03096 Masimo TraumaSen LNCS Inf/Ped Bx20CAUTION: With specialty sensors, the sensor-off detection performance may be compromised.NOTE: Trauma Sensors are only for use with Masimo SET technology.


LNCS Reusable SpO2 Sensors

Assorted Sensor Accessories

RD SET Adhesive SpO2 Sensors

ROW PN USA PN Japan PN DescriptionMP00796 MP03019 MP03097 Masimo SpO2-Sensor LNCS DC-IMP00795 MP03020 MP03098 Masimo SpO2-Sensor LNCS DC-IPMP00788 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 MultiMP02993 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.

ROW PN USA PN Japan PN Description7496933 MP03045 MP03147 SpO2 Posey Wrap Masimo 12 pcs7496917 MP03046 MP03148 SpO2 Wrap for Masimo LNOP YI7496909 MP03047 MP03149 SpO2 Masimo Petite Wrap 100 pcs7496875 MP03048 MP03150 SpO2 Masimo adh square, 12 pcs7496891 MP03049 MP03151 SpO2 Masmiso FOAMWRAPLNOP 12PCMP03197 MP03050 MP03152 Headband for LNOP/LNCS TF-IMP03198 MP03051 MP03153 Adhesive Pad LNOP/LNCS TF-I

ROW PN USA PN Japan PN DescriptionMS33726 MS33745 MS33764 Masimo SpO2 RD SET Adt Bx20MS33727 MS33746 MS33765 Masimo SpO2 RD SET Pdt Bx20MS33728 MS33747 MS33766 Masimo SpO2 RD SET Inf Bx20MS33729 MS33748 MS33767 Masimo SpO2 RD SET Neo Bx20MS33730 MS33749 MS33768 Masimo SpO2 RD SET NeoPt Bx20


RD SET Adhesive Trauma Sensors

RD SET Reusable SpO2 Sensors

RD SET Adapter Cables

RD SET Intermediate Cables

Nellcor FLEXMAX Reusable Sensors

ROW PN USA PN Japan PN DescriptionMS40088 MS40086 MS40087 RD-SET Trauma Adt Bx20MS40091 MS40089 MS40090 RD-SET Trauma Inf/Pd Bx20MS40094 MS40092 MS40093 RD-SET Trauma Neo Bx20CAUTION: With specialty sensors, the sensor-off detection performance may be compromised.NOTE: Trauma Sensors are only for use with Masimo SET technology.

ROW PN USA PN Japan PN DescriptionMS33740 MS33759 MS33778 Masimo SpO2-Sen RD SET DC-IMS33741 MS33760 MS33779 Masimo SpO2-Sen RD SET DCIPMS40067 MS40065 MS40066 Masimo SpO2 RD-SET TC-I*MS40070 MS40068 MS40069 Masimo SpO2 RD-SET YIMS40073 MS40071 MS40072 Masimo SpO2 RD-SET TF-I**NOTE: Only for use with Masimo SET technology.

ROW PN USA PN Japan PN DescriptionMS33731 MS33750 MS33769 RD to LNOP adapterMS33732 MS33751 MS33770 RD to LNCS adapterMS33733 MS33752 MS33771 RD to MM adapter cableMS33734 MS33753 MS33772 RD to M-LNCS adapter

PN DescriptionMS34436 SpO2 intermediate cable Masimo RD-SET, 1.2 mMS34437 SpO2 intermediate cable Masimo RD-SET, 3 mNOTE: 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.

PN DescriptionMS34677 Nellcor FLEXMAX Adt, SpO2 sensor, adult, fingerMS34678 Nellcor FLEXMAX Pdt, SpO2 sensor, pediatric, finger*NOTE: Only for use with Nellcor Oximar technology.


Mainstream etCO2

Infinity PiCCO Pod

Infinity PiCCO Pod Connecting Cables

PN Description6871950 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.

PN DescriptionMS32282 Infinity kit:

1 Infinity PiCCO pod2 Dräger 10-pin Transducer Adapter Cable 1 PULSION pressure transducer to PiCCO pod interface cable, 20 cm1 PiCCO pod CO injectate thermistor cable1 PiCCO pod CO catheter cable1 PiCCO pod CO intermediate cable, 1.5 m1 PodCom Cable to monitor (3 m)1 Universal Pole MountNOTE: All disposables are delivered by PULSION directly.

MS23133 Infinity PiCCO pod

PN DescriptionMS22532 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.

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

Draeger Medical Systems, Inc.3135 Quarry RoadTelford, PA 18969-1042U.S.A.(215) 721-5400(800) 4DRAGER(800 437-2437)

FAX (215) 723-5935http://www.draeger.com

in Europe, Middle East, Africa, Latin America, Asia Pacific distributed by

Drägerwerk AG & Co. KGaAMoislinger Allee 53 – 55D-23542 Lübeck Germany+49 451 8 82-0

FAX +49 451 8 82-20 80http://www.draeger.com

MS32082 – RI 01 en© Drägerwerk AG & Co. KGaAEdition: 2 – 2020-05(Edition: 1 – 2014-11)

Dräger reserves the right to make modifications to the device without prior notice.

Documents

Supplement Infinity Delta Series...A-2000, BIS ®, BISx® ... For this product, users, service personnel, and ex-perts are defined as target groups. These target groups must have received