Supplement Infinity Delta Series · Supplement – Infinity® Delta Series Software VF10.1 11...

Supplement

Infinity® Delta Series

Infinity® Patient Monitoring SeriesSoftware VF10.1

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

Supplement – Infinity® Delta Series Software VF10.1 3

Supplement for Infinity Delta Series Software

Infinity Delta Series Instructions for use

Software VF10.1

©Drägerwerk AG & Co. KGaA

All rights reserved.

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 prohibited without prior written permission of Dräger.

Before using any Dräger devices, carefully read all the manuals that are provided with your device. Patient 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®, DualHemo®, QuadHemo®, Infinity®, Perseus®, SmartPod®, Trident®, Pick and Go®, Scio®, and OxiSure® are trademarks of Dräger.

PiCCO®, PULSION®, and PULSIOCATH® are trademarks of PULSION Medical Systems.

CAPNOSTAT® is a trademark of Philips.

A-2000, BIS, BISx, Bispectral Index, Microstream, INVOS, and Nellcor are trademarks and registered trademarks of a Medtronic company.

CNAP® is a trademark of CNSystems Medizintechnik AG.

Masimo®, Masimo SET®, and Signal Extraction Technology (SET)® are trademarks of Masimo Corporation.

Dismozon® is a trademark of BODE Chemie.

Oxycide® is a trademark of Ecolab USA.

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Unpublished rights reserved under the copyright laws of the United States.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 restrictions 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 covered 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 applications pending.

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


4 Supplement – Infinity® Delta Series Software VF10.1

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.

Safety information

Definition of Target Groups

Target groups for this product include users, service personnel, and experts.

These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, reprocess, maintain, or repair the product. Contact Dräger for training options.

The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.

Users

Users are persons who use the product in accordance with its intended use.

Service Personnel

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

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

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

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



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).

WARNINGRisk of serious personal injury, death or property damage.

The monitor can detach from the docking station and fall if: – the mount is faulty– the monitor is not securely locked in the docking station

If any part of the docking station appears faulty, do not install it or attach a monitor to it. Contact your hospital’s service personnel.

Follow the installation instructions provided with the mount.

Position the docking station in a safe location away from the patient.

To prevent the monitor from falling, ensure that it is securely locked in the docking station. When securely locked, the Battery Charge indicator located on the lower-left front panel of the monitor is lit.

For more information on docking the monitor, see the main IFU.

http://www.draeger.com



Introduction

Changes in Delta VF10.1

Starting with Delta VF10.1, the following VGA Display requirement has been removed from the Display Unit (Kappa only) table under the Displays heading.

Output resolution:

High resolution mode: 1024 x 768

Medium resolution mode: 800 x 600

Low resolution mode: 640 x 480

System Components

Applicable Software Options (on a memory option card) include:

Options for Delta only:

– Delta second PodPort option – Pod Comm

Delta, Delta XL and Kappa:

– 4 to 5 channel option – Delta 4-5 Channels

– 6 to 8 channel option – Delta 6-8 Channels

– 3-Lead ST-segment analysis option – ST Monitoring

– ARIES option – Aries S/W

– Hemodynamic Calculations option – Hemodynamic Calculations

– ACE full arrhythmia option – Arrhythmia II

– Hemo/Oxy/Vent Calculations option package – Hemo/Oxy/Vent Calculations

– OR mode option (loaded in the monitor) – OR Single Unit

– OR Mode option (loaded in the IDS or Kappa Advanced Communication Option II) – OR Site



Cybersecurity and Network Stability

Corrected vulnerabilities that may cause device to reboot, lose functionality, and/or lose communication.

Base Unit

Monitor Rear View – Delta XL

Monitor Setup

Main Menu Setup

Date & Time is no longer a selection in the Main Menu > Monitor Setup > Monitor Options submenu. Date and time changes are only permitted by qualified hospital technical personnel or Dräger Service personnel in the password-protected Service menu.

Unit Manager

The Unit Manager menu lets supervisory personnel configure monitoring functions for the clinical staff. Access to this menu is restricted by a password.

1 External (lead-acid) battery compartment (not supported with software VF9.0 or higher)

2 Connector for docking station interface plate

3 Connector for AC adaptor

4 Slot for etCO2 modules



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 reminder tone sounds every 30 seconds at 50% volume.

Audio OFF Reminder (Alarm Control 1 submenu)

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

– Enabled (default) - When the alarm volume is set to OFF, 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 parameter box flashes and a reminder tone (high, medium, or low) sounds every 30 seconds at 50% volume.

– Disabled - There is no reminder tone when alarm volume is set to OFF.

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., retains prior settings).



Device Markings

The following table contains symbols that have been modified or added to the table in the section on device markings in the main IFU.

Caution: This product contains natural rubber latex which may cause an allergic reaction

Manufacturer’s reorder code

Date of manufacture Device serial number

Acceptable storage temerature ECG waveform out

Acceptable atmospheric pressure range

ECG Sync out

Acceptable humidity range Arterial waveform out

Contains DEHP Medical Device



Biomed

Quick Reference - Biomed Menu

Menu Item Description Settings/ProceduresMainstream CO2 Component Log

This read-only field contains information to assist with system upgrades and diagnosing field issues.

The display is read-only.

Press the Menu fixed key. Select Monitor Setup>Biomed>Logs>Component Log



Temperature Display

All temperature readings appear on the main screen according to their position in Parameter Priority (see page 2-6). The following display conventions govern temperature labels and values.

The monitor displays temperature values in one parameter box for each pod connector (MultiMed, He-mo2/Hemo4). The variables “a” and “b” denote the first or second probe connector from the MultiMed with Y-cable, NeoMed, Hemo2, Hemo4 pod or the MPod – Quad Hemo. When acquired via the MultiMed or NeoMed pod, temperature signals are displayed as Ta <value> or Tb <value>. (If you are using a MultiMed without a Y-cable, only Ta displays a value.)

When monitoring temperature using the Hemo2, Hemo4 pod, or the MPod – Quad Hemo, temperature values are further identified according to where they are connected to the monitor. The temperature value corresponding to the device hooked up to the Aux/Hemo2 PodCom connector is labeled T2a or T2b, while the temperature value corresponding to the device hooked up to the Aux/Hemo3 connector is labeled T3a or T3b.

NOTEThe transient response time for the monitor is less than 2.5 seconds.



Network Applications

Network Message (Delta/Delta XL/Kappa). . . . 14Remote View . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Connections to IT networks . . . . . . . . . . . . . 14Information about connecting to an IT network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Disconnecting the monitor from the network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Power Sources . . . . . . . . . . . . . . . . . . . . . . . . 17Battery Power. . . . . . . . . . . . . . . . . . . . . . . . . . 17

Admission, Transfer, and Discharge . . . . . . 18

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19General Requirements - Alarm Setup . . . . . . . 19Alarm History Table . . . . . . . . . . . . . . . . . . . . . 21Alarm Latching . . . . . . . . . . . . . . . . . . . . . . . . . 21

ECG and Heart Rate . . . . . . . . . . . . . . . . . . . . 22

ECG and Heart Rate . . . . . . . . . . . . . . . . . . . . 22ECG Leads. . . . . . . . . . . . . . . . . . . . . . . . . . . . 22ECG Setup Menu . . . . . . . . . . . . . . . . . . . . . . . 23

Arrhythmia Monitoring. . . . . . . . . . . . . . . . . . 24Arrhythmia Ranges and Defaults . . . . . . . . . . . 24

Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Non-Invasive Blood Pressure . . . . . . . . . . . . 26Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26NBP Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Status Messages . . . . . . . . . . . . . . . . . . . . . . . 29

Continuous Non-invasive Arterial Blood Pressure (CNAP) Pod. . . . . . . . . . . . . . . . . . . 30CNAP Calibration . . . . . . . . . . . . . . . . . . . . . . . 31Status Messages . . . . . . . . . . . . . . . . . . . . . . . 31

Maintenance (CNAP) . . . . . . . . . . . . . . . . . . . 31Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Definition of Maintenance Concepts . . . . . . . . 32Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . 33Inspection/ Safety Check. . . . . . . . . . . . . . . . . 33Metrological checks. . . . . . . . . . . . . . . . . . . . . 34

Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Pulse Oximetry (SpO2) . . . . . . . . . . . . . . . . . 35Quick Reference Table - SpO2 Setup . . . . . . . 37New Status Message. . . . . . . . . . . . . . . . . . . . 37

Dräger Mainstream etCO2 Monitoring. . . . . 38Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Connecting the Sensor . . . . . . . . . . . . . . . . . . 42Getting Started . . . . . . . . . . . . . . . . . . . . . . . . 43Device Conflicts. . . . . . . . . . . . . . . . . . . . . . . . 43Display Features . . . . . . . . . . . . . . . . . . . . . . . 45Capnograms . . . . . . . . . . . . . . . . . . . . . . . . . . 49Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . 51Status Messages . . . . . . . . . . . . . . . . . . . . . . . 54

Respiratory Mechanics . . . . . . . . . . . . . . . . . 55

FiO2 (Fractional Inspired O2) monitoring . . 56Display Features . . . . . . . . . . . . . . . . . . . . . . . 56

MultiGas Monitoring . . . . . . . . . . . . . . . . . . . 56xMAC (MAC multiple) . . . . . . . . . . . . . . . . . . . 56Status Messages . . . . . . . . . . . . . . . . . . . . . . . 59

Neuromuscular Transmission (NMT) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Patient Preparation . . . . . . . . . . . . . . . . . . . . . 60

Pulse Contour Cardiac Output (PiCCO) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Overview of the Infinity PiCCO Pod . . . . . . . . 61To set up the PiCCO Pod . . . . . . . . . . . . . . . . 63



Quick Reference - PiCCO Setup . . . . . . . . . . . 66Optimizing Results for PiCCO Measurements . . . . . . . . . . . . . . . . . . . . . . . . . 66

Peripheral Devices and Associated Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Analysis Tool. . . . . . . . . . . . . . . . . . . . . . . . . . . 67Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Compatible devices . . . . . . . . . . . . . . . . . . . . . 68Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 71Ventilation and Anesthesia Devices . . . . . . . . . 71Atlan, Primus, Zeus, Apollo, and Perseus Anesthesia Devices . . . . . . . . . . . . . . . . . . . . . 75Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C. . . . . . . . . . 79

Information on reprocessing. . . . . . . . . . . . . 79Safety information. . . . . . . . . . . . . . . . . . . . . . . 79

Classifications for reprocessing. . . . . . . . . . 80Classification of medical devices . . . . . . . . . . . 80Classification of device-specific components . . 80

Reprocessing list . . . . . . . . . . . . . . . . . . . . . . 81

Reprocessing procedures . . . . . . . . . . . . . . . 81Validated reprocessing procedures . . . . . . . . . 81Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Surface disinfection with cleaning . . . . . . . . . . 83

Cleaning and Disinfecting . . . . . . . . . . . . . . . 83IBP - Infinity PiCCO Pod. . . . . . . . . . . . . . . . . . 83etCO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84To dry the sidestream pump subsystem. . . . . . 85

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 85Electromagnetic Compatibility (EMC). . . . . . . . 85Electromagnetic Emissions . . . . . . . . . . . . . . . 88Electromagnetic Immunity . . . . . . . . . . . . . . . . 89Recommended separation distances . . . . . . . . 90

EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 91General information . . . . . . . . . . . . . . . . . . . . . 91Electromagnetic environment . . . . . . . . . . . . . . 91Recommended separation distances from wireless communication devices . . . . . . . . . . . 92

System Components . . . . . . . . . . . . . . . . . . . . 93Monitoring Accessories . . . . . . . . . . . . . . . . . . 94Monitoring Specifications. . . . . . . . . . . . . . . . . 96

Approved Options and Accessories . . . . . . 108Temperature probe covers . . . . . . . . . . . . . . . 108Invasive Blood Pressure (IBP) . . . . . . . . . . . . 109Pulse Oximeter (SpO2) . . . . . . . . . . . . . . . . . . 109Nellcor FLEXMAX reusable sensors . . . . . . . . 112Mainstream etCO2 . . . . . . . . . . . . . . . . . . . . . 113Infinity PiCCO Pod . . . . . . . . . . . . . . . . . . . . . 113Infinity PiCCO Pod Connecting Cables . . . . . . 113

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 114Admission, Transfer, and Discharge . . . . . . . . 114Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115ECG and Heart Rate . . . . . . . . . . . . . . . . . . . . 115Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . 115Pulse Oximetry (SpO2) . . . . . . . . . . . . . . . . . . 116Dräger Mainstream etCO2 Monitoring . . . . . . 116Pulse Contour Cardiac Output (PiCCO) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Peripheral Devices and Associated Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117



Network Message (Delta/Delta XL/Kappa)

The Condition for the Duplicate Address message should read as follows:

More than one monitor configured for the same IP address.

Remote View

Remote view of an IACS or M540 monitor from a Delta Series Monitor may not display all of the information properly. Refer to the primary source device for all diagnostic and therapeutic decisions.

Remote view of a Delta Series Monitor from an IACS or M540 monitor may not display all of the information properly. Refer to the primary source device for all diagnostic and therapeutic decisions.

Connections to IT networks

In an IT network, data can be exchanged by means of wired or wireless technologies. An IT network can be any data interface (e.g., RS232, LAN, USB, printer interface) that is described in standards and conventions.

During operation, this device can exchange information with other devices by means of IT networks and supports the following functions:

– Display of waveforms and parameter data

– Signaling of alarms

– Recording, storing, and printing

– Remote control (e.g., alarm management)

– Bed view by remote access

– Access to saved patient data

– Transfer of device settings and patient data

Connecting this device to a network that incorporates other devices or making subsequent changes to that network can lead to new risks for patients, users, and third parties. Before the device is connected to the network or the network is changed, these risks must be identified, analyzed, and evaluated, and appropriate measures taken.

Examples of subsequent changes to the network:

– Changing the network configuration

– Removing devices from the network

CAUTIONIf the Duplicate Address network message is displayed, contact your Biomed or local DrägerService.



– Adding new devices to the network

– Performing upgrades or updates on devices that are connected to the network

Information about connecting to an IT network

Prerequisites

This device must only be connected to the network by service personnel. The IT representative of the hospital must be consulted in advance.

The following documents must be observed:

– Accompanying documents of this device

– Descriptions of the network

– Description of the network-based alarm systems

Dräger recommends complying with IEC 80001-1 (risk management for IT networks with medical devices).

LAN networks

– LAN networks are usually configured in a star topology. Individual devices can be combined into groups by means of layer-n-switches. Other data traffic is decoupled by means of separate VLAN networks. Configure the network settings of the device in accordance with these instructions for use and the network specifications.

– Specifications for LAN connections are described in the following standards:– Wired networks: IEEE˽802.3– Wireless networks: IEEE˽802.11 (b, g)

– If the device is used with a layer-2-switch or a layer-3-switch, the port settings must be configured on the network switch. Before the device is shipped, Dräger can configure the network settings of the device so that they are compatible with the specifications of the operating organization.

– This device exchanges data with other medical devices over the LAN network. The network must support the following transmissions and protocols:– TCP/IP– Unicast (static or dynamic addressing with the ARP or RARP network protocols)– Multicast– Broadcast– IGMP (version 2)

This device can join or leave an IP multicast group by using the IGMP network protocol.



VLAN networks

If data is being exchanged within a single physical network and a clinical information system is used, an independent VLAN network must be set up for the clinical information system. Additionally, at least one of the following independent VLAN networks must be set up:

– Network for medical devices for intrahospital use

– Network for portable patient monitors

WLAN networks

– On Dräger devices, the Advanced Encryption Standard (AES) WPA2 with pre-shared key administration is used during installation.

– With some Dräger clinical devices, the installation is carried out using SSL and additional functions that are defined in the form "Manufacturer Disclosure Statement for Medical Device Security" (MDS2).

Serial interfaces

The following interfaces are supported:

– RS232 interfaces conforming to EIA RS232 (CCITT V.24/V.28) for the following applications:– MEDIBUS, MEDIBUS.X– Paging systems– Connections to medical devices from other manufacturers

– Interfaces conforming to IEEE˽1073 (Medical Information Bus) for connection to medical devices from other manufacturersThe requirements of IEEE 1073.3.2 or the combined requirements of IEEE 1073.3.1 and IEEE 1073.4.1 must be complied with.

Consequences of using an unsuitable network

If the network does not meet the requirements, hazardous situations can result. The following situations can occur with this device:

– Due to unsafe distributed alarm system:– Alarms are not transmitted.– Alarms or data are delayed.– False alarms are indicated.

– During an interruption of the network connection:– Alarms are not transmitted.– Suppressed alarms or alarm tones are not reactivated, but remain suppressed.

– Without firewall and antivirus software:– Data are not protected.– Device settings are changed.– The device generates false alarms or no alarms.

– Data are sent incomplete, sent to the wrong device, or not sent at all.

– Patient data are intercepted, falsified, or damaged.



– Data have incorrect time stamps.

Requirements for the electrical characteristics of connected devices and networks

The LAN interfaces and the serial interfaces are only suitable for the connection of devices or networks that have a rated voltage of at most 24 V DC on the network side and that meet the requirements of one of the following standards:

– IEC 60950-1: Ungrounded SELV circuits

– IEC 60601-1 (as of 2nd edition): Touchable secondary circuits

Disconnecting the monitor from the network

1 Hold the monitor firmly by its handle. Slide the lever to the left to disengage the power supply. The mon-itor automatically switches to battery power.

2 Continue to move the lever to the left until it clicks. Use both hands to tilt the monitor forward and lift it off the IDS or Docking Station.

3 When docking and undocking the monitor to and from an IDS, a minimum 15 second delay between undocking and redocking the monitor is required, for loading the default IDS profile to the monitor.

Power Sources

Battery Power

The following information refers to the table on battery charge display as described in the main IFU.

NOTEWhen the internal battery has approximately 20 minutes remaining, a low priority alarm sounds and the message Monitor Internal Battery Low appears. The alarm can be silenced; however, the banner message remains visible.



Admission, Transfer, and Discharge

Admitting a patient at the Central Station

1 Select the viewport that corresponds to the room/patient monitor.

2 Click on Admit/Standby.

3 Click on the Demographics tab if it is not already selected.

4 Enter the patient information in the appropriate fields.

5 Click on Apply to confirm your entry.

If you pre-admit a patient to a discharged Delta patient monitor, the monitor exits discharge.

NOTE To change the patient’s category (adult, pediatric, or neonatal), you must access the Patient

Setup menu at the bedside monitor.

If you change a patient’s category, the weight selection is cleared and must be entered again.

In neonatal mode, additional settings (gestational age and birth weight) are available at the bedside monitor only. Day of Life and corrected GA values also appear in a read only field.

Entries and changes regarding a patient’s height and weight affect all other monitor menus and displays that use this information.

For more information on admission at the Delta, see the Instructions For Use for the Delta monitor.

Dräger recommends that patients be admitted at the Infinity CentralStation.



Alarms

General Requirements - Alarm Setup

Upper and Lower Alarm Limits

In addition to those listed in the main IFU, alarm limits should be set according to your patient’s prevailing condition within the predefined ranges of the monitor as listed in the following table:

Parameter Predefined Alarm Range and Resolution

Default State Default Alarm Setting

inCO2/inCO2* 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 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 current value


ΔT1, ΔT2, ΔT3, PVC/min, inCO2/inCO2*

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 current 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 current 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 overwritten). Events are deleted when the patient is discharged. Data is stored in the monitor and remains with the patient during Pick and Go transports. Data also survives power shutdowns. The Alarm History table records all high-priority and medium-priority alarms as well as selected low-priority alarms for MultiGas and Dräger Mainstream CO2 monitoring (e.g., alarms relating to module disconnection). The Alarm History table also records every activation and deactivation of cardiac bypass mode, every change of patient category, and records whenever you perform an All Alarms OFF/All Alarms Paused or Audio Paused/Alarm Silence. Switching the device on and off is not recorded.

Alarm Latching

Some alarms are latched: they continue to annunciate visually and audibly until you acknowledge them manually, even if the condition that caused the alarm no longer exists. Other alarms may be latched only partially, as indicated in the following table:

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 Signal Processing and Display

The monitor identifies QRS complexes with amplitudes between 0.2 and 5.0 mV and a QRS width of 70 to 120 ms for adults (or 40 to 120 ms for neonates). It calculates heart rates within a range of 15 to 300 beats per minute, using the R-R intervals of the last 10 seconds and diisregarding the two longest and two shortest R-R intervals. It averages the remaining intervals, and displays the result as the current heart rate in the HR parameter box on the main screen.

ECG and Heart Rate

ECG Leads

The number of available ECG leads depends on the type of pod and cable set you are using, as shown in the following tables.

Regular ECG Leads

ECG Pod Number of Lead Wires Channels Leads Available

NeoMed 3 lead ECG1 I, II, III3

MultiMed 5 3 lead

5 lead

ECG1

ECG1, ECG2, ECG3 1

I, II, III2

I, II, III, aVR, aVL, aVF, V 2

MultiMed 6 3 lead

5 lead

6 lead

ECG1

ECG1, ECG2, ECG3 1

ECG1, ECG2, ECG3 1

I, II, III


I, II, III, aVR, aVL, aVF, V, V+ 2

MultiMed 12 5 lead

6 lead

12 lead

ECG1, ECG2, ECG3 1

ECG1, ECG2, ECG3 1

ECG1, ECG2, ECG3 1


I, II, III, aVR, aVL, aVF, V, V+ 2

I, II, III, aVR, aVL, aVF, V1-V6 2

1 ECG3 is available only when HR, ARR, and ST parameter boxes are on the main screen.2 V and V+ are V2 and V5 chest leads with 6 and 12 lead; aVR, aVL, and aVF are augmented leads.3 I or II or III are labeled on the ECG cable as RA, LA, LL



ECG Setup Menu

Menu selection Description Available SettingsThe ECG Options submenuThis 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 selection.

CAUTION: Fusion mode pacer detection is not intended for use with large-signal, unipolar pacemakers. It is intended for use only with bipolar pacemakers.

In basic mode:

– Select ON to enable pacemaker detection.

– Select OFF (default) to disable pacemaker detection.

Pacer Detection (continued)

Observe the following:

– Select Fusion mode only in situations 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 programmed as appropriate for that patient.

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

In advanced mode:

– Select ON to enable pacemaker detection.

– Select OFF (default) to disable pacemaker detection.

– Select Fusion to enable pacer detection, 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 Priority 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)

Increments of 105 to 15 (10) Increments 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) Increments of 10

3 to 10 (3) Increments of 1

Str./Rec.

TACH MED 100 to 200 (130) Increments of 10

5 to 15 (8) Increments 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 priority 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 second 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 the rotary 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 information, 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

Available in software levels equal to or greater than VF9.1, and supports venous stasis in adult mode only (with adult-based inflation pressures).

NOTEThe accuracy of the oscillometric blood pressure signal can decrease (up to loss of measurement) under the following conditions:– Weak pulses– Irregular pulses– Patient movement artifacts– Tremor artifacts– Respiratory artifacts– Pulses generated from a ventricular assist

device

These conditions may prevent the monitor from performing a measurement within the maximum allowable measurement time.

NBP hose connector

Kappa

Delta/Delta XL

NBP hose connector



Status Messages

Message Possible Cause Suggested Action

NBP Cannot Measure

The pulse profile is too poor to make a reliable measurement (usually due to persistent motion artifact).

• Check the patient and treat, if necessary.

• Move the cuff to a limb with less movement.

• Restart measurement. If the message persists, contact the hospital’s technical personnel or DrägerService.

• Take a manual measurement if the condition persists.

NBP Measurement Timeout

A measurement was aborted (usually due to motion artifact) because it lasted longer than two minutes (adult or pediatric) or 90 seconds (neonatal).

• Repeat the measurement.• Take a manual measurement if the

condition persists.



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 inflation pressure alternates between the dual finger cuffs, CNAP automatically calibrates. Calibration consists of a pulse determination phase followed by an NBP correlation measurement. During calibration a triangular wave (for pod firmware version 2.14.14.) displays in the CNAP waveform area and then the message CNAP @ Calibrating displays and the CNAP values are blank. After a successful NBP measurement, the CNAP waveform and CNAP values display.

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 @ Calibrating

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

NOTECalibration could take up to 2.5 minutes. Depending on the pod firmware version, a triangular waveform or intermittent ascending/descending 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 represents an 83% duty cycle.

WARNINGRisk of infectionUsers and service personnel can become infected with pathogenic germs.Disinfect and clean the device or the device parts before any maintenance measures and also before returning the medical device for repair.



Definition of Maintenance Concepts

Concept Definition

WARNINGRisk of electric shockComponents that carry current are located under the cover. Do not remove the cover. Maintenance measures must be performed by the responsible personnel. Dräger recommends DrägerService to perform these measures.

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 activities 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 obtaining a service contract with DrägerService through your vendor. For repairs we recommend that you 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 accessories or immerse these components in liquid, allow them to dry completely for at least 24 hours to 48 hours. Contact your hospital's technical personnel to test whether any such component is fully operational before putting it back in clinical use.

Maintenance All measures (inspection, preventive maintenance, repair) intended to maintain and restore the functional condition of a medical device.

Inspection Measures intended to determine and assess the actual state of a medical device.Preventive 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 observe 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 and power plugs and discontinue use if there are any signs of damage.

4 Inspect all patient cables, leads, and strain reliefs for general condition. Make sure the connectors are properly engaged at each end.

Inspection/ 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 replacement of wear parts) as identified by the manufacturer. Perform safety checks at the indicated intervals.

1 Check accompanying documents:

– Instructions for use are available

2 Perform a functional test of the following features according to the instructions for use:

– CNAP pod

– Cuff controller

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 regular basis, the proper operation of the medical device can be compromised. Perform safety checks at the indicated interval.



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

– Check/Visual inspection

3 Check that the device combination is in good condition:

– All labels are complete and legible

– There is no visible damage

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

5 Check the electrical safety requirements according to IEC 62353.

Metrological checks

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

– Body temperature

– Non-invasive blood pressure

Preventive Maintenance

The following table shows the preventive maintenance intervals:

WARNINGRisk of faulty components

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

WARNINGRisk of electric shock

Before performing any maintenance work, disconnect all electrical connectors from the power supply.

Component Interval Measure Responsible PersonnelCNAP SmartPod Every 2 years Check ExpertCNAP cuff controller Every 2 years Check ExpertAir pump Every 2 years Replace Expert



Calculations

The following table lists the parameter labels that have been updated in the Calculations chapter.

Pulse Oximetry (SpO2)

Updated label Former labelCstat Cs

inO2 iO2

Pmean MAP

Pplat PAUSE

Re Raw e

Ri Raw i

RR RRv

VTe TVe

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

WARNINGThe pulsations from intra-aortic balloon support 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 dyshemoglobins, such as carboxyhemoglobin or methemoglobin, measurement accuracy may be reduced.Do not rely on measurement data if the SpO2 sensor is used under these conditions.

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

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



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

WARNINGRisk of inaccurate data

In the presence of shock, low blood pressure, severe vasoconstriction, major anemia, hypothermia, arterial occlusion proximal to the sensor, and asystole, the pulse rate may be inaccurate.

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 associated cables away from the surgical site, the electro-surgical unit return cathode, and the earth ground.

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

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.



Quick Reference Table - SpO2 Setup

New Status Message

The following status message applies to any monitor using a Masimo SET pod.

MicrO2+ Standalone Pulse Oximeter

As of the Infinity Delta Series Software VF10.1 release, MicrO2+ is no longer supported.

Menu item Description SettingsPulse Tone Volume

Sets the volume of the pulse tone.

NOTE: You can also set the pulse tone volume from the ECG menu.

OFF, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100

SpO2 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%

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

expired or defective.Replace the sensor or the cable.



Dräger Mainstream etCO2 Monitoring

Application

Intended Use

The Dräger Mainstream CO2 module, when connected to a monitor, allows the monitor to measure and display mainstream etCO2 (end-tidal CO2), inCO2 (inspired CO2), and RRc (Respiration Rate) for neonate, pediatric, and adult patients. Respiratory phases are determined from excursion of the CO2 data through a threshold which is adaptively calculated from the CO2 curve. The maximum CO2 value during the expiratory phase is taken as end-tidal CO2 (etCO2), immediately shown after each breath. The Dräger Mainstream CO2 module cannot be used simultaneously with Scio Four modules.

Precautions

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

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

WARNINGRisk of misinterpretation

Misdiagnosis or misinterpretation of the measured values or other parameters can endanger the patient. Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. Therapeutic decisions must be made solely by qualified users.

WARNINGRisk to patient safety

The etCO2-related information displayed is intended 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, inCO2, and RRc alarms do not activate until the second breath is detected after turning on the monitor or discharging a patient.

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

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

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

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 resonance 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 uncuffed endotracheal tube or a damaged cuvette) may significantly affect CO2 measurement values.

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



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, cables, and accessories to the monitor.

CAUTIONTo prevent leakage, make sure the cuvette is firmly connected to the breathing circuit.

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

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

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

NOTEWhen etCO2, inCO2 or RRc is followed by * (for example, etCO2*), the * indicates the origin of this parameter is from an external device such as an A500, A350, or A300.



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 module to monitor



Connecting the Sensor

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

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 optical properties different from the cuvette windows of the disposable cuvette. Therefore, select the cuvette type correctly; otherwise, the zero point shifts by up to 8 mmHg CO2 (1.1 kPa CO2).

F

G

H

I

F Dräger mainstream CO2 sensor I Tracheal tube adapter

G Y-piece

H Cuvette



Getting Started

Patient Preparation for Dräger Mainstream CO2 Monitoring

The following tips provide optimal monitoring results 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, N2O, or HeliOx, select the gas that is being administered in the etCO2 parameter menu. Make sure to adjust the atmospheric pressure to the actual value. Failure to compensate for supplemental gases results in inaccurate measurement values.

When switching cuvette types (from reusable to disposable or adult to pediatric, or vice versa), it is not necessary to rezero a Dräger sensor. If the sensor window is clean and the correct sensor type is chosen in the etCO2 parameter menu (under Cuvette Type), only zero a Dräger sensor when the measurement value is suspect. Otherwise, perform zeroing once a day or when prompted to rezero.

Initialization

Upon start-up, the sensor goes through a warm-up period (status message CO2 Warming Up appears). During this time (approximately 30 seconds), concentrations for CO2 may not be available.

Device Conflicts

CO2 can be sourced from many devices.

When more than one source of CO2 is detected by Delta, a conflict occurs. Depending on the combination of duplicate sources of CO2 or CO2*, Delta responds to the conflict with the Source dialog or with one of the following two error messages:

– Duplicate Device Connected

– Disconnect Duplicate etCO2 Pods

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

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



Source dialog

When Delta detects both a mainstream and SCIO device are connected, the Source dialog appears.

The user must select the preferred device from the dialog, or disconnect either the mainstream or SCIO device to exit the screen lock.

To select the source of CO2 from the Source dialog:

– Dial to Mainstream or SCIO accordingly and click to select it.

To select the source of CO2 manually:

1 Click the CO2 or CO2* parameter box (whichever is active) on the Main screen.

2 Click Source.

3 Dial to Mainstream or SCIO accordingly and click to select it.

Duplicate Device Connected

The message Duplicate Device Connected appears when multiple CO2* devices are connected to the monitor (for example, a Dräger ventilator and a Scio Four module that is connected 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 disconnect the undesired CO2* device.

A label in the upper left corner of the etCO2* waveform identifies the CO2* device that is providing information to the user.

Disconnect Duplicate etCO2 Pods

When Delta detects any two or more of the devices listed below are connected, the message Disconnect Duplicate etCO2 Pods appears:

– Mainstream

– Microstream

– etCO2 + Respiratory Mechanics Pod

– etCO2 Pod

– etCO2 Cartridge

NOTEDelta continues to monitor the first device connected (mainstream or SCIO) until it is disconnected or the alternate device is selected from the Source dialog.

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



The suggested action is to disconnect the duplicate device.

Display Features

etCO2 Monitoring

The etCO2 waveform displays the instantaneous CO2 concentration. The etCO2 parameter box displays the following parameters:

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

– Inspired CO2 (inCO2) — The level of CO2 in the airway during the inspiration phase.

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

etCO2 Param eter Box

Typical etCO2 parameter box displays are shown below.

A etCO2 (end-tidal CO2) label and value

B etCO2 alarm limits

C inCO2 (inspired CO2) label and value

D inCO2 alarm limit (upper limit only)

E Respiration rate label and value

F Respiration rate alarm limits

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

NOTEThe patient monitor does not alarm for etCO2 violations until it has established a valid respiratory rate.

A

B

C

DE

F

inCO2



etCO2 Setup

To access the etCO2 setup menu

Click on the etCO2 parameter box.

or

1 Press the Menu fixed key.

2 Click on Patient Setup.

3 Click on Parameters to display a list of available parameters.

4 Click on etCO2.

Quick Reference Table - etCO2 Setup

Click on the etCO2 parameter box to execute etCO2 setup functions:Menu Item Description SettingsSource Describes what CO2 device is connected and

displays parameters on the monitor.

NOTE– If one CO2 device is connected to the

monitor, the setting automatically displays the appropriate device (read-only).

– If two CO2 devices are connected, the settings are made available to the user to select the desired CO2 device.

(See also the “Multiple CO2 Devices” section.)

– SCIO– Mainstream

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)

Gas Compensation

Determines gas percentages for inspiratory and expiratory breathing.

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

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)



Quick Reference Table - etCO2* Setup

Click on the etCO2* parameter box to execute etCO2* setup functions:

Calibration Check

Checks the calibration of the CO2 sensor with a test filter. The monitor reports whether the calibration check has passed or failed.

NOTEThe sensor must be removed from the cuvette and zeroed before performing a calibration check. During the calibration check the sensor must be connected to the test filter.

CO2 Zero

(Only available if a Dräger Mainstream CO2 module is connected.)

Zeroes the CO2 sensor. The CO2 sensor stores a new zero point for CO2 measurements.

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.

Apnea Alarm Displays the Apnea Alarm menu. – RRc Apnea Time– Apnea Archive

etCO2 Alarm Accesses the Alarm Limits table where you can set upper and lower alarm thresholds. See the Alarms chapter for more information about setting and displaying alarm limits.

WARNING

etCO2 alarms do not activate until the second breath is detected after turning on the monitor, admitting a patient or disconnecting and reconnecting the Mainstream CO2 sensor or module.

Not applicable

Menu Item Description Settings

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

displays parameters on the monitor.

NOTE– If no CO2* device is connected, “None”

displays (read-only).– If one CO2* device is connected to the

monitor, the setting automatically displays the appropriate device (read-only).

– If two CO2* devices are connected, the settings are made available to the user to select the desired CO2* device.

(See also the “Multiple CO2 Devices” section.)

– SCIO– Mainstream– 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)

Agent Display Displays a separate agent parameter box. Ghosted if the monitor is displaying combined MultiGas parameter box.

– ON– OFF

Pressure Comp. Sets the compensation for ambient atmospheric pressure.This item is always set to auto and is ghosted.

– Auto

RRc* Apnea Time

Sets the time that the monitors waits before reporting a cessation of breathing as an apnea event.

OFF, 10, 15, 20, 25, 30 s

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

OFF, 10, 15, 20, 25, 30 s

(Adult: OFF default)

(Pediatric/neonatal: 15 s default)MultiGas Zero Manually zeros the SCIO module (parameter

values disappear during zeroing).Not applicable

Auto Zero Delay Delays automatic zeroing for 5 minutes for uninterrupted monitoring.

WARNING: Delaying the auto zero may impact accuracy.

NOTE: Gas sensors in the SCIO module are automatically zeroed and calibrated against room air. Parameter values disappear during zeroing. One minute before automatic zeroing, the monitor sounds an attention tone and displays the message Auto zero in <1 minute.

Not applicable

etCO2* Alarm Accesses etCO2* alarms in Alarm Limits table (see Chapter 5 of the main IFU)

WARNING

etCO2* alarms do not activate until the first breath is detected after turning on the monitor or discharging a patient.

Menu Item Description Settings



Quick Reference Table--Apnea Alarm submenu

The following table explains apnea alarm submenu functions.

Smart Apnea

In OR mode only, the monitor automatically engages the Smart Apnea feature for RRc* apnea alarms if RRc Apnea Time is set to a selection other than OFF in the etCO2 parameter menu.The Smart Alarm feature escalates an apnea alarm in the following manner:

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

Capnograms

The monitor also displays an instantaneous CO2 waveform or capnogram.

Function Description Settings RRc Apnea Time Specifies time monitor waits before reporting a

cessation of breathing as an apnea event. OFF, 10, 15, 20, 25, and 30 s

Apnea Archive Allows you to automatically store and/or record an alarm event for apnea. You can later review store alarms on the Event Recall screen.

OFF, Record, Store (de-fault), Str./Rec.

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

NOTEIf the monitor detects multiple CO2 devices, the first device that was connected to the monitor retains priority until the user selects a different CO2 device in the etCO2 parameter menu or the undesired CO2 is physically disconnected from the monitor.



Zeroing

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

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

1 Remove the Dräger mainstream CO2 sensor from the cuvette.

2 Select CO2 Zero under the etCO2 parameter menu. The monitor performs the zeroing operation and displays a message that the CO2 zeroing is in progress. Waveforms flatline and parameter box values disappear from the screen during this cycle.

3 Fit the Dräger mainstream CO2 sensor onto the cuvette.

If zero was successful, the monitor displays the message CO2 Zero Accepted after approximately 30 seconds. If zero was unsuccessful, the monitor displays the message CO2 Zero Failed. Repeat the zeroing operation. If the zero remains unsuccessful, check whether the sensor is contaminated, clean it if necessary, and re-zero. If the zero remains unsuccessful, the sensor may be defective and require replacement.

A Expiratory or alveolar plateau (level of CO2 in lungs ceases to increase significantly)

B End-tidal concentration point (end of expiration phase, where CO2 is measured)C Onset of inspiration phaseD Onset of expiratory phaseE Baseline during inspiration

AB

C

DE



Checking Calibration of the Dräger Mainstream CO2 Sensor with Test Filter

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

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 connect it to the test filter on the sensor cable.

2 Access the etCO2 parameter menu.

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

If the check was successful

The monitor displays the message, Filter Check Successful. The test value is within the permissible tolerance.

Fit the Dräger mainstream CO2 sensor back on the cuvette.

If the check was not successful

The monitor displays the message, Filter Check Failed. The test value is outside the permissible tolerance.

Contact DrägerService.

Troubleshooting

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

Test filter



The following table lists the alarm messages in order of priority.

Alarm Priority Alarm Cause Remedy

Medium inCO2 > # Leakage in the breathing system.

Exchange breathing system.

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 inCO2 @ Out Of Range (High)

Inspiratory gas concentration has exceeded the upper measuring range.

Check ventilation.

Medium inCO2 @ 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 TypeNOTE: Measured parameter labels display but are followed by a “?” to indicate reduced accuracy.

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.

Inspiratory CO2 concentration high.

• Check ventilation settings.

• Check CO2 absorber• Check patient condition.

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

Message Condition Suggested actionCO2 Please Zero Zero has drifted Perform a zeroing operationCO2 Reduced Accuracy

Measurement values have reduced accuracy due to warm-up or because the Dräger mainstream CO2 sensor is becoming too warm.

NOTE– Measured parameter labels display

but are followed by a “?”.– Alarm history displays CO2 Reduced

Accuracy. When this condition is removed, the alarm history displays CO2 Reduced Accuracy Ended

– Parameter box (Pbox) question marks (?) are not transmitted/displayed over the network. 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.



Respiratory Mechanics

The following table lists the parameter labels that have been updated in the Respiratory Mechanics chapter.

Updated label Former labelMValv mand MValv m

MValv spon MValv s

MVemand MVe m

MVespon MVe s

Pmean MAP

Re Raw e

Ri Raw i

RR RRv

RRmand RR m

RRspon RR s

Vds TVd aw

Vds/VTe TVd/TV aw

VT lk TV lk

VTalv mand TValv m

VTalv spon TValv s

VTalv TValv

VTCO2 TVCO2

VTe TVe

VTemand TVe m

VTespon TVe s

VTi TVi

VTimand TVi m

VTispon TVi s



FiO2 (Fractional Inspired O2) monitoring

Display Features

MultiGas Monitoring

If there is a secondary anesthetic agent already present while the Delta is admitted (taken out of Discharge), that secondary agent is not trended. Powering on and admitting the monitor before starting anesthetic gas measurements prevents this issue from occurring.

If the secondary anesthetic agent changes to the primary anesthetic agent, the agent is trended.

xMAC (MAC multiple)

The Delta monitor can calculate an xMAC value from all SCIO Four modules (SCIO Four, SCIO Four Oxi, SCIO Four plus, and SCIO Four Oxi plus).

The xMAC value is a simple navigation aid for anesthetic agent delivery.

The xMAC is the MAC multiple calculated from the current expiratory measured values and the age-dependent MAC values.

MAC (minimum alveolar concentration) is the anesthetic gas concentration in the blood at 760 mmHg (1013 hPa) at which 50% of patients no longer respond to a skin incision with movement. The integrated xMAC algorithm is based on the MAC values shown in the following table. The MAC values are dependent upon the age of the patient. The values specified in the table (according to ISO 80601-2-55) apply to a patient age of 40 years.

NOTEWhen FiO2 is followed by * (FiO2*), the * indicates the origin of this parameter is from a ventilator. For more information on FiO2*, see the main IFU.

Agent MAC corresponds to: (in 100% O2, at age 40)

Desflurane 6.0 Vol%Enflurane 1.7 Vol%Halothane 0.77 Vol%Isoflurane 1.15 Vol%Nitrous oxide 105 Vol%Sevoflurane 2.1 Vol%



The age-corrected MAC values are calculated using an equation developed by W. W. Mapleson (British Journal of Anaesthesia 1996, pp. 179-185). The equation applies to patients older than 1 year.

The Delta series monitor allows the user to select whether Standard, Age-Corrected, or no xMAC calculation is provided. The xMAC calculation is automatically adjusted according to the ambient pressure measured by the gas analyzer. The influence of other drugs (opiates or intravenous hypnotics) is not considered in the xMAC calculation.

Standard xMAC Calculation

When calculating the Standard xMAC for gas mixtures, the respective multiples for N2O and anesthetic agents are added according to the following equation:

The xMAC standard calculation assumes a patient age of 40.

Standard xMAC example:

exp. conc. Anesth1 = etIso = 0.65 Vol%

exp. conc. N2O = etN2O = 69 Vol%

NOTEThese values are guiding values only. The binding values are specified on the package information leaflet of the anesthetic agent.

NOTEThe xMAC Calc. selection in the Agent menu determines whether standard, age-corrected, or no xMAC values are used.

NOTEWhen connecting to a Dräger SCIO module or to a device using a protocol other than MEDIBUS.X:– If Delta receives two anesthetic agents, xMAC displays locally only; it is not available on the network

for remote view or storage.– If Delta receives one anesthetic agent, xMAC displays locally and is also available on the network

for remote view and storage, except that at ICS the xMAC value is shown without the label and in Bed View only.

Connection to Dräger devices using MEDIBUS.X protocol does not have these limitations; xMAC from those devices is available on the network and displays correctly, including at ICS Bed View and Main Screen.



MAC (Iso) = 1.15 Vol%

MAC (N2O) = 105 Vol%

xMACstandard = (0.65 Vol% / 1.15 Vol%) + (69 Vol% / 105 Vol%) = 0.57 + 0.66 = 1.2

Age-Corrected xMAC Calculation

When calculating the Age-Corrected xMAC for gas mixtures, the respective multiples for N2O and anesthetic agents are added according to the following equation:

Age-Corrected xMAC example:

exp. conc. Anesth1 = etIso = 0.65 Vol%

exp. conc. N2O = etN2O = 69 Vol%

age = 72 years

MACage corrected (Iso, 72 years) = 1.15 Vol% x 10-0.00269 x (72-40) = 0.94 Vol%

MACage corrected (N2O, 72 years) = 105 Vol% x 10-0.00269 x (72-40) = 86.1 Vol%

xMACage corrected = (0.65 Vol% / 0.94 Vol%) + (69 Vol% / 86.1 Vol%) = 0.69 + 0.80= 1.49

CAUTIONRisk due to incorrect setting for patient age

The patient’s age is derived from the birth date entered in the Patient Admit menu. Incorrect settings can lead to inappropriate xMAC values and therefore to inappropriate anesthetic gas delivery.Always set the patient age correctly.



Troubleshooting

The following table describes alarms in alphabetical order by alarm message:

Status Messages

Alarm priority Alarm Cause RemedyLow 2 Mixed Agents A second anesthetic

agent has been detected.– Wait for the transition phase

to end after changing anesthetic 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 anesthetic 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 settings.

Low MultiGas Module Disconnected

Gas analyzer is disconnected.

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

DrägerService.Medium inO2 > # Inspiratory O2

concentration has exceeded the upper alarm limit

Check O2 concentration and fresh-gas settings

Message Condition Suggested actionDuplicate Device Connected

Multiple CO2* devices are connected.

– Select the desired CO2* device in the etCO2* Parameter menu.

– Disconnect the unwanted, duplicate CO2* device.



Neuromuscular Transmission (NMT) Monitoring

Precautions

Patient Preparation

Careful skin preparation is important to ensure appropriate electric contact for stimulation. Follow the clinical techniques approved at your hospital for preparing the patient's skin prior to administering the electrodes.

MultiGas Reduced Accuracy

Warm-up phase in progress.

NOTES– Measured parameter labels

display but are followed by a “?”.

– Alarm history displays MultiGas Reduced Accuracy. When this condition is removed, the alarm history displays MultiGas Reduced Accuracy Ended.

– Parameter box (Pbox) question marks (?) are not transmitted/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, allow the auto zero to occur.

– If the problem persists, call DrägerService.

MultiGas Zero Accepted

The zeroing cycle was successful.

No action is required.

Message Condition Suggested action

WARNINGTo avoid serious injury to the patient, apply the stimulation electrodes close together as described. Do not apply the electrodes transcerebrally (across the head), directly over the eyes, covering the mouth, on the front of the neck (particularly over the carotid sinus), trans-thoracically (across the chest), on the upper back, or other position(s) that could place the electrodes over the heart. Doing so can cause electrical current to enter the chest or head and may lead to irregularities in cardiac rhythm or brain activity, or to pain.



Pulse Contour Cardiac Output (PiCCO) Monitoring

Pulse Contour parameters/Transpulmonary Thermodilution parameters

The following parameters are not cleared for use by the FDA in the US market: dPmax, GEF, and PVPI.

Precautions

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

WARNINGDo not use the PiCCO pod on patients for which placement of an indwelling arterial or central venous catheter is contraindicated.



1 Initiates a zeroing of all connected pressures

5 Transducer plate

2 Starts a p-CO measurement 6 Monitor connector (to pod communication cable)

3 Transducer slots

NOTE: On the Infinity PiCCO pod, the transducers are attached to a separatetransducer plate and are available from the applicable manufacturer; pur-chase them locally or contact your Dräger representative for information.

7 CO connector

4 Pulsion blood pressure transducer 8 10-pin transducer adapter cable

NOTE: Cables are permanently fastened to the back of the Infinity PiCCO pod.

1 23 5

46 7

8



To set up the PiCCO Pod

1

2

3

4

5

6

57

8

9

10

11

12

1

1 CVP catheter 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 carefully using the flush clip. Air bubbles in the pressure lines or in the transducer influence the transmission and can cause measuring errors.

3 Insert an arterial thermodilution catheter into a suitable artery (femoral,brachial or axillary artery) of the patient. Ensure that all air is evacuated 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 connect 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 beneath 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 label 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 pressure transducer to the Delta/Delta XL/Kappa Delta series monitor.

13 If you have not already done so, enter the patient 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 zeroing 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.



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

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

17 Repeat step 15 to take an additional measurement, making sure you wait for the READY message. If a temperature drop is not detected within four minutes, the Averaging screen closes, and the current p-CO values are averaged and saved. You must repeat steps 15 and 16 if additional p-CO measurements are necessary.

NOTE: If the procedure is successful, the monitor displays the message: <IBP> @ Zero Accepted. If the procedure fails, the monitor displays the message: <IBP> @ Did Not Zero. Check the waveform. If spikes exceed three millimeters, repeat the procedure. If the procedure fails after two attempts, replace the transducer or consult your hospital’s technical personnel.

Single Transducer Zero Simultaneous “Smart Zero”

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

NOTE– In order to avoid disruption of p-CO thermodilution measurement, avoid connecting or

disconnecting any cables or changing any menus when measurements are in progress.– During a measurement, if p-IT or p-BT readings become invalid or go out of range, the averaging

screen disappears.– p-BT values are intended for p-CO thermodilution calibration and should not be used for the body

temperature of the patient.

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.



Quick Reference - PiCCO Setup

Optimizing Results for PiCCO Measurements

Arterial blood pressure signal

A good arterial blood pressure signal is mandatory (not under or over dampened). Before TD measurements, check arterial signal, and if necessary flush pressure line to optimize pressure signal/values. If there is an unstable or static ART pressure signal, the p-CO curve or value may not be generated because the calibration in this situation may not be accurate.

Amount of Bolus

15cc of iced injectate is normally adequate for most adult patients.

If room temperature injectate is used, it is recommended that 20cc of injectate be used.

Thermodilution (TD) Measurements

Always try to make at least three thermodilution measurements to calibrate the PCCO measurement.

Wait until READY is displayed before injection.

Check that valid C.O average values are obtained before saving these values.

Pulse Contour Parameters Setup Menu

Menu Item Description Available Settings

CVP Value Allows user to select a CVP Value.

NOTE: The auto CVP Value, if available, is used until the manual CVP Value menu is enabled. If auto CVP Value is unavailable or is out of range, a default of 5 mmHg is used.

5 mmHg (default)0 mmHg to 50 mmHg(in increments of 1 mmHg)

CAUTIONWhen using PiCCO, the Filter setting in the ART menu should be set to 16Hz or 32Hz only. Using the Filter setting of 8Hz may affect PiCCO measurement accuracy.

CAUTIONThe delivered injectate volume must always match the Injectate Volume setting in the Thermodilution menu. Administering an injectate volume that is different from the Injectate Volume setting can significantly affect the accuracy of the thermodilution measurement.



During a measurement, if p-IT or p-BT readings become invalid or go out of range, the averaging screen disappears. Check that p-ITand p-BT are in range before restarting the measurement.[p-IT range: -3 to 31 °C (27 to 88 °F), p-BT range: 25 to 43 °C (77 to 109 °F)]

Peripheral Devices and Associated Software

Analysis Tool

When receiving data from the Perseus A500, or Atlan A350/300, if the Analysis Tool is open and the A500,A350, or A300 exits standby, the VTi parameter label is not displayed. Close and reopen the Analysis Tool to restore the parameter label.

Overview

This chapter describes interfaces that can be used to connect the bedside monitor to peripheral devices and supported ventilators and anesthesia systems. This chapter also describes the Analysis tool and the Independent Surgical Display.

A monitor with compatible software displays waveforms and parameter values acquired from peripheral devices via the general Medical Information Bus (MIB) interface protocol or the MEDIBUS.X interface protocol. These protocols significantly expand the monitor's capabilities. The MIB protocol and the MEDIBUS.X protocol require the monitor to be connected to an Infinity Docking Station (IDS).The MEDIBUS.X interface protocol allows the peripheral device to be connected directly to the IDS. The MIB interface protocol requires the MIB II protocol converter to connect the device to the IDS.

The Delta series monitor displays only a subset of the parameters supported by these devices but relays all supported parameters to the infinity network and networked devices.

CAUTIONRecalibration of the thermodilution measurement is recommended at least every eight hours and with significant changes in hemodynamic conditions such as volume shifts or changes to medication.

NOTE“Analysis tool” replaces “Open Lung tool” throughout these instructions for use.

NOTEMIB and MEDIBUS.X functionality is not available when the monitor is in DirectNet mode.

NOTERefer to the RS-232 export handbook for information on which parameters are available for export protocol. The RS-232 export handbook is available in English only.



When a MEDIBUS.X device is in standby, the Delta series monitor does not process parameters, settings, waveforms, or modes (i.e., this data is not displayed on the Delta series monitor and is not sent to the Infinity network).

Parameter values acquired from peripheral devices are trended in graphical and tabular format. When you modify the parameter display, a message identifies the trend data that will be lost if the trend storage capacity is reached.

In the list of parameters available from specific peripheral devices later in this chapter, an asterisk (*) identifies parameters that duplicate the monitor's parameters.

Consult device documentation for details on setup and operation.

Compatible devices

The following table lists the devices supported by the Delta series monitors.

NOTEDelta series monitors support Medibus.X version 1.07.

MIB II Duo Protocol Converter(PN: 72 56 949)

MIB II Protocol Converter(PN: 72 56 931)

Input: RS232, 25 Pin DInput: RS232, 25 Pin D

Output: RJ45 MIBOutput MIB II: RJ45 MIB

Output MIB I: SDL

Device MIB Interface Protocol MEDIBUS.X Interface Protocol

Dräger Anesthesia devicesInfinity Perseus A500 No Yes

Atlan A350/A300 No Yes

Dräger Apollo Yes No

Dräger Fabius Family Yes No

Dräger Primus Yes No



Dräger Primus Infinity Empowered Yes No

Dräger Zeus Yes No

Dräger Zeus Infinity Empowered Yes No

Dräger ventilatorsDräger Babylog Yes No

Dräger Babylog VN500 No Yes

Dräger Evita 4 Yes No

Dräger Evita XL Yes No

Dräger Evita V500 No Yes

Dräger Evita V300 No Yes

Dräger Savina Yes No

Dräger Savina 300 No Yes

Dräger Infant Warmers and IncubatorsDräger Babytherm Infant Warmer Yes No

Dräger C2000/C2000e Infant Incubator Yes No

Dräger Caleo Infant Incubator Yes No

Other devicesGE Aestiva/Aspire 7100 anesthesia machine Yes No

GE Aestiva/Aspire 7900 anesthesia machine Yes No

Puritan Bennett 840 ventilator Yes No

Siemens/Maquet Servo-i ventilator Yes No

Covidien/Medtronic INVOS 5100C Cerebral/Somatic Oximeter

Yes No

Edwards Vigileo SvO2/CCO monitor Yes No

Device MIB Interface Protocol MEDIBUS.X Interface Protocol

WARNINGThe above table lists all of the external devices that Dräger has validated. Dräger cannot make any claim for the reliability of the data for any devices that have not been validated. In the interest of patient safety and device performance, do not connect to the monitor devices which have not been validated by Dräger. The hospital is responsible for contacting Dräger to determine the compatibility and warranty status of any connection made to medical devices not listed in the table.



MEDIBUS.X Protocol Support

MEDIBUS.X ventilators and anesthesia devices send parameters, settings, text messages or modes, and waveforms to the network via the Delta series monitor.

Supported MEDIBUS.X Waveforms

The Delta monitor can simultaneously display the following three waveforms when using the MEDIBUS.X protocol.

NOTEDelta series software VF10 and IDS software VF6.0 or higher support the MEDIBUS.X protocol for integrating external device information into the monitor system and Infinity network.

NOTEThe Patient Category and Patient Category-specific settings align with the configured patient category on the Delta monitor and are independent of that selected on the source device. The selected patient category determines specific monitoring settings for the selected patient. Make sure you select the appropriate patient category for the monitored patient on the Delta and the MEDIBUS X. device.

NOTEThe unit of measure displayed for each parameter, waveform, and trend aligns with the configured unit of measure on the Delta monitor and is independent of that displayed on the source device.

Waveform label

Description Unit of measure

Paw Airway pressure

cmH2O

Flow Inspiratory and expiratory flow

L/min

CO2 Carbon dioxide concentration

mmHg, kPa,%



Precautions

See sections “Electro surgery” and “General Electrical Safety” for general precautions regarding device operation.

Ventilation and Anesthesia Devices

The bedside monitor uses the airway pressure (Paw) and the ventilation (Vent) parameter boxes and waveform channels to display ventilation parameter values, waveforms, and loops. Parameter values acquired from the ventilator are trended in graphical and tabular form.

The ventilator provides the range and resolution for all parameters. Parameter settings, alarms, and error messages do not display on the bedside monitor; they are displayed on the network device instead.

CAUTION– Data transferred using the MEDIBUS protocol or MEDIBUS.X protocol is for information only and

is not intended as a basis for diagnostic or therapeutic decisions. Always refer to the primary data source for these decisions.

– Connecting peripheral devices is supported via the device connection option's RS232 connection. Only connect peripheral medical devices to a patient monitor if those devices comply with the electrical safety requirements found in IEC 60601-1. Refer to the Electrical Safety section for information on how to connect devices safely.

NOTE– The MIB II option will not work if a network cable is connected to it. Likewise the MIB II duo protocol

converter will not work if it is connected to an IDS network connector.– An RJ-45 cable can plug into the MIB II duo protocol converter's X6 connector (MIB I output);

however, this cable cannot be removed if it locks into place (the protocol converter is unusable and must be returned for service if this occurs). Only remove the label that covers the X6 connector if the protocol converter is to be operated in MIB I mode.

NOTERefer to the instructions for use of the source device for detailed information on external parameters.

Refer to the instructions for use for your network devices such as an Infinity CentralStation, Innovian, Gateway, or Symphony for a list of parameters transferred from the ventilator.

Refer to the "Atlan, Primus, Zeus, Apollo, and Perseus Anesthesia Devices" section for detailed information on those anesthesia devices, which also provide gas monitoring.



The monitor displays a ventilator pressure waveform next to the Airway Pressure (Paw) parameter box and a ventilator flow waveform next to the Flow/Volume (Vent) parameter box.

For MEDIBUS.X devices, the monitor can also display the CO2 waveform next to the End-Tidal CO2 (etCO2*) parameter box.

Supported Ventilator Parameters

When the inO2 parameter is received from a connected ventilator, the inO2 parameter is trended as FiO2* on the Delta Series monitor.

The following table lists the parameters for all ventilators.

NOTEFor information on calculating parameter values, see the documentation for the peripheral device you are using.

CAUTIONThe parameter abbreviations on the bedside monitor may differ from those displayed on the ventilator (refer to the "Ventilation Parameters" table).

The bedside monitor displays pressure units in cmH2O while the ventilator displays pressure units in mbar (1 cmH2O being equal to 1 mbar approximately).



Ventilation Parameters

Parameter Bedside monitor label

Bedside and Infinity network units of measure

Where locally displayed Former label

Peak inspiratory pressure

PIP cmH2O • Paw (Flow andVolume) parameter box

• Show All Parameters screen• Ventilation split screenMean airway

pressurePmean cmH2O MAP

Positive end-expiratory pressure

PEEP cmH2O

Respiratory rate RR /min • Vent (Flow andVolume) parameter box

• Show All Parameters screen• Ventilation split screen

RRv

Expiratory minute volume

MVe 1 L/min • Vent (Flow andVolume) parameter box

• Ventilation split screenExpiratory tidal volume

VTe 2 ml TVe

End-tidal CO2 concentration

etCO2* mmHg, kPa,%

• etCO2* parameter box• Show All Parameters screen

Inspiratory oxygen fraction

inO2

NOTE: may show as FiO2 on the network or source device

% • MultiGas parameter box (when MultiGas is enabled)

• O2/N2O parameter box (when MultiGas is disabled)

• Show All Parameters screen• Ventilation split screenNOTE: in the Show All Parameters screen, inO2 displays as FiO2*

iO2

Plateau pressure Pplat cmH2O • Show All Parameters screen• Ventilation split screen

Pause

Ratio of Inspiratory time to Expiratory time

I:E



Tidal volume 3 VT ml • Show All Parameters screen

Minute volume 3 MV L/min

Spontaneous respiratory rate 4

RRspon /min RRs

Mandatory respiratory rate

RRmand /min RRm

Leakage minute volume in% of inspiratory minute volume 4

% leak %

Dynamic compliance 4

Cdyn ml/cmH2O

Resistance 4 R cmH2O/l/s Raw

Inspiration Time 5 InspT% % • Ventilation split screen1 Appears as MV on the following non-MEDIBUS.X devices: Evita V500, Primus, Apollo, and Zeus.2 Appears as VT on non-MEDIBUS.X Evita V500 devices.3 Supported by MEDIBUS.X devices only.4 Available for Evita/Evita XL, MEDIBUS.X Evita V500, and MEDIBUS.X Savina 300 only.5 Not supported by MEDIBUS.X devices.






Atlan, Primus, Zeus, Apollo, and Perseus Anesthesia Devices

The Delta/Delta XL/Kappa monitor displays data from the devices listed at the beginning of this chapter.

When the monitor is connected to an Infinity Primus, Apollo, Perseus,or Atlan anesthesia machine, it displays the concentrations of CO2, O2, N2O, and anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, or Desflurane). The "Anesthesia Parameters" table lists all displayed parameters.

The monitor uses the multigas parameter box, etCO2* parameter box, and waveform channels to display parameter values, waveforms, and loops. The agent parameter box displays agent concentrations for anesthetic gases.

Parameter values acquired from the anesthesia machine are trended in graphical and tabular form.The anesthesia machine provides the range and resolution for all parameters.

Parameter settings, alarms, and error messages are not displayed on the monitor. They are displayed on the network device such as an Infinity CentralStation, Innovian, Gateway, or Symphony instead. See the Instructions for Use for your network device for the list of parameters transferred from the anesthesia machine. Refer to the Primus, Apollo, Perseus,and Atlan instructions for use for details on calculating parameter values.

NOTEThe Infinity Primus and the Zeus anesthesia machines are not sold in the United States.

NOTEThe bedside monitor displays the xMAC (MAC multiple) values only if available and sent by the connected anesthesia device.



Anesthesia Parameters




Peak inspiratory pressure

PIP cmH2O • Paw (Flow andVolume) parameter box

• Show All ParametersMean airway pressure

Pmean cmH2O MAP

Positive end-expiratory pressure

PEEP cmH2O

Respiratory rate RR /min • Vent (Flow andVolume) parameter box

• Show All Parameters screen

RRv

Inspiratory carbon dioxide concentration

inCO2* mmHg, kPa,%

• etCO2* parameter box• Show All Parameters screen

CO2*

End-tidal CO2 concentration

etCO2* mmHg, kPa,%

MAC multiple derived from expiratory concentrations

xMAC

NOTE: may appear as MAC exp on the network

• Agent parameter box• Show All Parameters screen

MAC

Inspiratory oxygen fraction

inO2

NOTE: may appear as FiO2 on the network or source device

% • MultiGas parameter box• Show All Parameters screenNOTE: in the Show All Param-eters screen, inO2 displays as FiO2*

iO2

End-tidal oxygen concentration

etO2 % • MultiGas parameter box (when MultiGas is enabled)

• O2/N2O parameter box (when MultiGas is disabled)

• Show All Parameters screen

Respiratory rate based on carbon dioxide measurement

RRc* /min • etCO2 parameter box



End-tidal desflurane concentration

etDes % • MultiGas parameter box (when MultiGas is enabled)

• Agent parameter box (when MultiGas is disabled)

etDES

End-tidal enflurane concentration

etEnf % etENF

End-tidal halothane concentration

etHal % etHAL

End-tidal isoflurane concentration

etIso % et ISO

End-tidal sevoflurane concentration

etSev % etSEV

Inspiratory desflurane concentration

inDes % iDES

Inspiratory enflurane concentration

inEnf % iENF

Inspiratory halothane concentration

inHal % iHAL

Inspiratory isoflurane concentration

inIso % i ISO

Inspiratory sevoflurane concentration

inSev % iSEV

End-tidal nitrous oxide concentration

etN2O % • MultiGas parameter box (when MultiGas is enabled)

• O2/N2O parameter box (when MultiGas is disabled)Inspiratory nitrous

oxide concentrationinN2O % iN2O






Plateau pressure Pplat cmH2O • Show All Parameters screen Pause

Tidal volume 1 VT ml

Spontaneous minute volume 1

MVspon L/min MVs

Mandatory minute volume 1

MVmand L/min MVm

Minute volume 1 MV L/min

Spontaneous respiratory rate

RRspon /min RRs

Mandatory respiratory rate

RRmand /min RRm

Dynamic compliance Cdyn ml/cmH2O

Resistance R cmH2O/l/s Raw

Inspiratory concentration of primary agent 1

inPrimA %

End-tidal concentration of primary agent 1

etPrimA %

Inspiratory concentration of secondary agent 1

inSecA %

End-tidal concentration of secondary agent 1

etSecA %

1 Supported by MEDIBUS.X devices only






Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C

The monitor, when connected to a Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C via MIB, displays cerebral oximetry.

Reprocessing

The following information on reprocessing applies only to the Delta monitor. For information on reprocessing for Delta accessories, please see the section on cleaning and disinfecting as described in this supplement and the main IFU.

Information on reprocessing

Instructions for reprocessing are based on internationally accepted guidelines, e.g., standard ISO 17664.

Safety information

NOTEThe Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C is now available in adult, pediatric, and neonatal patient categories.

WARNINGRisk due to inappropriately reprocessed products

Reusable products must be reprocessed, otherwise there is an increased risk of infection.– Observe the hygiene regulations and reprocessing regulations of the healthcare facility.– Observe national hygiene regulations and reprocessing regulations.– Use validated procedures for reprocessing.– Reprocess reusable products after every use.– Observe the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing

devices.

CAUTIONRisk due to faulty products

Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with reprocessed products.

Check the products for signs of wear and replace them if necessary.



Classifications for reprocessing

Classification of medical devices

Medical devices and their components are classified according to the way they are used and the resulting risk.

Classification of device-specific components

Observe the instructions for use for the components.

The following classification is a recommendation from Dräger.

Non-critical

– Delta series monitors

Semi-critical A

– N/A

Semi-critical B

– N/A

Critical

– N/A

Classification ExplanationNon-critical Components that come only into contact with skin that is intactSemi-critical (A, B) Components that carry breathing gas or come into contact with mucous

membranes or pathologically altered skinCritical (A, B, C) Components that penetrate skin or mucous membranes or come into contact with

blood



Reprocessing list

Reprocessing procedures

Validated reprocessing procedures

At the time of product-specific validation, the following reprocessing procedures showed good material compatibility and effectiveness:

The effectiveness of the listed reprocessing procedures has been validated by independent laboratories that are certified to the standard ISO 17025.

Disinfectants

Use disinfectants that are nationally approved and are suitable for the particular reprocessing procedure.

Surface disinfectant

At the time of the test, the surface disinfectants listed in the following table showed good material compatibility. They can be used in addition to the surface disinfectants listed in the section "Validated reprocessing procedures".

The manufacturers of the surface disinfectants have verified at least the following spectra of activity:– Bactericidal– Yeasticidal– Virucidal or virucidal against enveloped viruses

Observe the specifications of the surface disinfectant manufacturers.

Components Surface disinfection with cleaning

Manual cleaning followed by disinfection by immersion

Machine cleaning with thermal disinfection

Steam sterilization

Special reprocessing measures

Delta series monitors

Yes N/A N/A N/A N/A

Procedure Agent Manufacturer Concen-tration

Contact time

Tempera-ture

Surface disinfection with cleaning

Dismozon Plus BODE Chemie 1.6 % 15 min N/AOxycide Ecolab USA 2.34 % 5 min N/A



Other surface disinfectants are used at one's own risk.

Dräger states that oxygen-releasing agents and chlorine-releasing agents may cause color change in some materials. Color change does not indicate that the product is not functioning correctly.

Class of active ingredient Surface disinfectant ManufacturerChlorine-releasing agents Actichlor plus Ecolab

BruTab 6S BrulinClorox Professional Disinfecting Bleach Cleaner

Clorox

Dispatch Hospital Cleaner Disin-fectant Towels with BleachKlorsept 17 Medentech

Oxygen-releasing agents Descogen Liquid AntisepticaDescogen Liquid r.f.u.Dismozon plus BODE ChemieDismozon purOxycide Ecolab USAPerform Schülke & MayrVirkon DuPont

Quaternary ammonium com-pounds

Mikrozid sensitive liquid1)

1) Virucidal against enveloped viruses

Schülke & MayrMikrozid sensitive wipes1)

Mikrozid alcohol free liquid1)

Mikrozid alcohol free wipes1)

acryl-des1)

Aldehydes Buraton 10 F Schülke & Mayr



Surface disinfection with cleaning

1 Remove soiling immediately. Use a cloth dampened with disinfectant to remove soiling.

2 Perform surface disinfection.

3 After the product has been exposed to the disinfectant for the specified contact time, remove residual disinfectant.

4 Wipe with a cloth dampened with water (preferably drinking-water quality). Allow the product to dry.

5 Check the product for visible soiling. Repeat steps 1 to 5 if necessary.

6 Check the product for visible damage and replace if necessary.

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

WARNINGRisk due to penetrating liquid

Penetrating liquid may cause the following:– Damage to the device– Electric shock– Device malfunctions

Ensure that no liquid penetrates the device.

CAUTIONDo not autoclave the Infinity PiCCO Pod.

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



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 approved 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.


etCO2

Dräger Mainstream CO2 Module, Sensor, and Cuvettes

Mainstream Module

To clean the Mainstream Module

1 Disconnect the sensor cable (SpO2 cable, if using) from the Dräger etCO2 mainstream module.

2 Wipe the module surfaces with a cloth moistened with a soap solution.


To disinfect the Mainstream Module

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

2 Wipe the module surfaces with a gauze moistened with one of the following:

– A 1:3 solution of alcohol

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


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.



To dry the sidestream pump subsystem

1 Reattach the etCO2 module or pod to the monitor. The sidestream sampling pump starts running, and there is suction at the input port on the face of the module or pod.

2 With the input sidestream port still open and the drain tubing still connected, let the pump run for several minutes to remove any water still trapped in the system.

3 Block the sidestream input port with your finger for several seconds and then unblock it. Repeat at least ten times.

4 Move your finger to the sidestream output port and block the port with your finger for several seconds and then unblock it. Repeat at least ten times.

5 Remove the drain tubing, and allow the sidestream pump to continue running for at least 30 minutes.

Technical Data

Electromagnetic Compatibility (EMC)Electromagnetic Immunity

NOTEIf the sidestream pump fails to start, make sure the Capnostat sensor is disconnected. The pump is designed to shut down while a connected sensor is warming up.

NOTESidestream accessories are for single use only. Do not reuse.

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




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:



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 MHz

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.



Electromagnetic Emissions


Emissions: Compliance according to: Electromagnetic environment:

RF emissions (CISPR 11) Group 1 The monitor only uses RF energy internally. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Also see the following note.

CISPR emissions Classification

Delta - Class B

Delta XL - Class B

Kappa - Class A

Infinity Docking Station (IDS), integrated MIB - Class A

SCIO Four Module - Class A

BISx pod - Class A

The equipment is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions(IEC 61000-3-2)

Class A

Voltage fluctuations / flicker (IEC 61000-3-3)

Complies

NOTEWhen the monitor is configured with the wireless option, that option's radio emits electromagnetic energy in order to communicate with the Infinity network. This may affect nearby equipment. See the documentation that accompanies the wireless option's radio for further details.

CAUTIONDo not place monitor with radio operational next to paced patients.



Electromagnetic Immunity


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


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

Common mode: ±2 kVDifferential mode: ±1 kV

±2 kV±1 kV


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:



Recommended separation distances

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 3 Vrms

Radiated rf(IEC 61000-4-3)

80 MHz to 800 MHz

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.

d 1.2∗ P=

d 1.2∗ P=

d 2.3∗ P=

Recommended separation distances between portable and mobile RF communications equipment and the equipment

Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter in meters

150 kHz - 80 MHz 80 MHz to 800MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23

d 1.2∗ P= d 1.2∗ P= d 2.3∗ P=



EMC declaration

General information

This device was tested for electromagnetic compatibility using accessories from the list of accessories. Other accessories may only be used if they do not compromise the electromagnetic compatibility. The use of non-compliant accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.

This device may be used in the direct vicinity of other devices only if Dräger has approved this device arrangement. If no approval has been given by Dräger, it must be ensured that this device functions correctly in the desired arrangement before use. The instructions for use for the other devices must be followed.

Electromagnetic environment

NOTE:• For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Emissions ComplianceRadiated emissions Kappa, Infinity Docking Station (IDS), integrated

MIB, SCIO Four Module, BISx pod:– Class A, group 1 (30 MHz to 1 GHz)

Delta, Delta XL:– Class B, group 1 (30 MHz to 1 GHz)

Conducted emissions Kappa, Infinity Docking Station (IDS), integrated MIB, SCIO Four Module, BISx pod:– Class A, group 1 (150 kHz to 30 MHz)

Delta, Delta XL:– Class B, group 1 (150 kHz to 30 MHz)



Recommended separation distances from wireless communication devices

To ensure that the functional integrity of this device is maintained, there must be a separation distance of at least 1.0 m (3.3 ft) between this device and wireless communication devices.

NOTEThe emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio-frequency communication ser-vices. The user might need to take mitigation measures, such as relocating or re-orienting the equip-ment.

Immunity against Test level and required electromagnetic environ-ment

Electrostatic discharge (ESD) (IEC 61000-4-2) Contact discharge: ±8 kVAir discharge: ±15 kV

Fast transient electrical disturbances (bursts) (IEC 61000-4-4)

Power cable: ±2 kVLonger signal input lines/output lines: ±1 kV

Impulse voltages (surges) (IEC 61000-4-5) Voltage, external conductor – external conductor: ±1 kVVoltage, external conductor – protective ground con-ductor: ±2 kV

Magnetic fields at mains frequency (IEC 61000-4-8)

30 A/m

Voltage dips and short interruptions in the supply voltage (IEC 61000-4-11)

100 % drop, 0.5 period

100 % dip, 1 period

30 % dip, 25/30 periods

Voltage interruptions:

100 % drop, 5 secondsRadiated high-frequency disturbances (IEC 61000-4-3)

80 MHz to 2.7 GHz: 3 V/m

Conducted high-frequency disturbances (IEC 61000-4-6)

150 kHz to 80 MHz: 3 Vrms, ISM bands: 6 Vrms

Electromagnetic fields in the vicinity of wireless communication devices

Various frequencies from 385 MHz to 5785 MHz: 9 V/m to 28 V/m, with various pulse modulations



System Components

Delta/Delta XL base unit

Kappa CPU base unit

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

Free field measurements (complying with ISO 3744) IEC/Infinity– High-priority alarms - 56 dB(A) to 69 dB(A) / 56 dB(A) to

76 dB(A)– Medium-priority alarms - 56 dB(A) to 69 dB(A) / 54 dB(A) to

72 dB(A)– Low-priority alarms - 52 dB(A) to 65 dB(A) / 41 dB(A) to

58 dB(A)

NOTE

The Infinity alarm volume must be set at 20% or higher to comply with the minimum audio sound pressure of 45 db specified in standard 60601-2-49.

Environmental RequirementsTemperature range: Operating: 10 to 45 °C (50 to 113 °F)

Storage: –15 to +45 °C (–5 to +113 °F)

NOTE

Storage of the monitor at 40 °C (104 °F) for an extended period of time (3 - 5 months) degrades the battery capacity.



Monitoring Accessories

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 (41 to 113 °F)

Storage: –40 to 70 °C (–40 to 158 °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 2.17 x 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 ingress

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

Mode of operation ContinuousProtection against electric shock

Sensor: Type BF

Defibrillator protection YesEnvironmental requirementsTemperature 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)



Monitoring Specifications

ECG

Respiration

Pulse Contour Cardiac Output (PiCCO)

WARNINGThe following parameters and functions are not monitored in neonatal mode: Arrhythmia, cardiac output, ST, pacer detection,% paced, and all MultiGas parameters.

Description ValueV/s pacer detected 3.18 V/s

Description ValueDetection threshold: 0.15Ω to 4.0Ω in manual mode (user adjustment)

Adult and Pediatric: 0.20Ω - 1.5Ω in auto mode(automatic adjustment)

Neonatal: 0.20Ω - 1.5Ω in auto mode(automatic adjustment)

Measurement range: Range: 0 - 154 breaths per min

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)

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 ±200 mmHg

Additional technical data



Non-Invasive Blood Pressure (NBP)

Non-Invasive Blood Pressure (NBP)

NOTEFor neonatal patients with high blood pressure and a heart rate close to 30 bpm, the monitor may not be able to measure NBP within the maximum measurement time of 90 seconds.

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 ±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)

Inflation pressure after a valid measurement (±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)



Continuous Non-Invasive Arterial Blood Pressure via CNAP Pod

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)

Parameter label CNAPSystolic CNAP-SDiastolic CNAP-DMean CNAP-M

NOTE: Only values for systolic, diastolic, and mean are displayed in the p-box. Labels are not displayed.

Units mmHg (kPa)Measuring range

Systolic 40 to 250 mmHg (5.3 to 33.3 kPa)Diastolic 30 to 210 mmHg (4 to 28 kPa)Mean 35 to 230 mmHg (4.66 to 30.7 kPa)

HR range (for CNAP measurements) 20 to 200 bpmAccuracy ± 5 mmHg (0.6 kPa)Display resolution 1 mmHg (0.1 kPa)Inflation pressure

Default 120 mmHg (16 kPa)Minimum 30 mmHg (4 kPa)Maximum 300 mmHg (40 kPa)

Over pressure limitPressure 300 mmHg (40 kPa) + 10%Response time ≤ 3 sDeflation time ≤ 15 s (to reach < 15 mmHg)



Pulse Oximetry (Masimo SET SpO2 via Pod)

Description ValueIntended use The Infinity Masimo SET® pod and accessories are

indicated for use during both motion and non-motion conditions and for patients who are well or poorly perfused.

Parameter display: Saturation (%SpO2), pulse rate, perfusionMeasurement 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)


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

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

Adults, pediatrics, neonates ±3Pulse Rate (bpm) - During motion conditions:(3,4)

Adults, pediatrics, neonates ±5

NOTES:1) Since pulse oximeter measurements are statistically distributed, only about two-thirds of those measurements can be expected to fall within ±1 Arms of the value measured by a co-oximeter.2) The Infinity Masimo SET SpO2 SmartPod pulse oximeter with LNOP-Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1 Arms of the value measured by a co-oximeter.3) The Masimo SET pod with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 - 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1 Arms of the value measured by a co-oximeter.4) The Masimo SET pod with LNOP-Neo PT and Neo Pt sensors has been validated for motion and no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 - 100% SpO2 against a laboratory co-oximeter and ECG monitor. 1% has been added to the results to account for the effects of fetal hemoglobin.5) The pulse rate accuracy has been validated on healthy adult volunteers during induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1 Arms of the pulse rate value measured by the ECG monitor.6) A functional tester cannot be used to assess the accuracy of a Pulse oximeter probe or a Pulse oximeter monitor.



Pulse Oximetry (Masimo RD SET SpO2 via pod)

Description ValueIntended use The Infinity Masimo SET® pod and accessories are

indicated for use during both motion and non-motion conditions and for patients who are well or poorly perfused.

Parameter display: Saturation (%SpO2), pulse rate, perfusionMeasurement range %SpO2: 1 to 100%

Pulse rate: 25 to 239 /minPerfusion: 0.02 to 20%

Measurement accuracy:The following are for all Masimo RD SET sensors.Saturation (%SpO2) - During conditions with no motion:



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


Pulse Rate (bpm) - During no motion conditions:Adults, pediatrics, neonates ±3

Pulse Rate (bpm) - During motion conditions:Adults, pediatrics, neonates ±5



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, FLEXMAX, FLEXMAX-P 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, FLEXMAX, FLEXMAX-P ±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 SensorDescription ValueParameter display etCO2, inCO2, RRcMeasuring principle Dual wavelength infrared absorptionMeasurement range etCO2 and inCO2: 0 to 99 mmHg

(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 inCO2:±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 inCO2: 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, inCO2: 1 mmHg (0.1 kPa)RRc*: 1 breath/min

Apnea detection Adult: YesPediatric: YesNeonatal: Yes

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



How Performance is affected by Barometric Pressure

:

Rise time <35 msDelay 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 humidity/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 replaced).

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 Dräger mainstream CO2 module incorporates compensation 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 automatically through the Gas Compensation selection.

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, O2, N2O, anesthetic agent or CO2, O2, N2, water vapor) is within specified tolerance.



NMT via Trident Pod

Stimulation current Auto mode: read-only; displayed value is based on referencemeasurement at startup (max. 60 mA)

Manual mode: 5 mA (default) to 60 mA, in increments of 5 mA

Pulse width 100, 200 (default), or 300 μs

Output polarity Monophasic

Measurement range NMT-Temp: 20 to 40 °CSingle: 0 to 200 % (of reference twitch)TOF-Ratio: 4 to 150 %TOF-Count: 0 to 4 (number of twitches displayed if TOF-Ratio <4 %

or number of twitches <4)PTC: 0 to 20 (number of twitches)

Measurement interval None, 1s, 10s, 20s (default), 1min, 5min, 15min, 30min

Impedance range 1.2 Ω to 6000 Ω (1)

Accuracy NMT-Temp:±1 °CSingle: ±10 %TOF-Ratio:±10 %

Display resolution NMT-Temp:1 °CSingle/TOF-Ratio:1%TOF-Count/PTC:1

Trend scale range NMT-Temp: 20 to 40° C (incr. of 1 °C)Single: 0 to 200 % (incr. of 5 %)TOF-Ratio: 0 to 150 % (incr. of 5 %)TOF-Count: 0 to 4 (incr. of 1)PTC: 0 to 20 (incr. of 1)

Maximum output charge per pulse frequency

18 μC (stimulation current of 60 mA, pulse width of 300 μs)

Maximum average current across a 500 Ω resistor

18 μA (stimulation current of 60 mA, pulse width of 300 μs)



Output signals Graphical signal of the output voltage and current stimulation pulse:

A – Voltage (Voff) or Current (Ioff) when pulse is not delivered (OFF)B – Voltage (Von) or Current (Ion) when pulse is delivered (ON)C – Pulse width (varies, dependent on setting)

1 Stimulation current accuracy is ±5% within this range. Stimulation current is disabled at impedance values greater than 8900 Ω.

2 At a stimulation current of 30 mA, voltage and current values are approximately half (50%) of those listed for 60 mA.

NOTE: There is no output in an open-circuited load condition.

A

B

C

Output voltage and current at stimulation current of 60mA(2)

Load impedence 1.2 Ω 500 Ω 1000 Ω 6000 ΩVon 0.07 V 29.2 V 60.8 V 342.0 VVoff 0 V 0 V 0 V 0 VIon 57.5 mA 59.8 mA 59.3 mA 57.0 mAIoff 0 mA 0 mA 0 mA 0 mA



Approved Options and Accessories

Temperature probe covers

ECG leads

Standard ECG lead sets (single pin version - for direct connection to MultiMed Plus and MultiMed Plus OR).

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

NOTEAll Draeger approved pods and associated accessories that have patient contact are manufactured without natural rubber latex, with the exception of the 7014616 temperature probe covers.

Some articles are not available worldwide because they are not approved in all countries.

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

MP03401 ECG 3-lead, grabber, 1m, single pin connector, IEC1 (European color code)MP03402 ECG 3-lead, grabber, 1m, single pin connector, IEC2 (AHA color code)MP03403 ECG 5-lead, grabber, 1/1.5m, single pin connector, IEC1 (European color code)MP03404 ECG 5-lead, grabber, 1/1.5m, single pin connector, IEC2 (AHA color code)MP03405 ECG 6-lead, grabber, 1/1.5m, single pin connector, IEC1 (European color code)MP03406 ECG 6-lead, grabber, 1/1.5m, single pin connector, IEC2 (AHA color code)

MP03411 ECG 3-lead, grabber, 1m, dual pin connector, IEC1 (European color code)MP03412 ECG 3-lead, grabber, 1m, dual pin connector, IEC2 (AHA color code)MP03413 ECG 5-lead, grabber, 1/1.5m, dual pin connector, IEC1 (European color code)MP03414 ECG 5-lead, grabber, 1/1.5m, dual pin connector, IEC2 (AHA color code)MP03415 ECG 6-lead, grabber, 1/1.5m, dual pin connector, IEC1 (European color code)MP03416 ECG 6-lead, grabber, 1/1.5m, dual pin connector, IEC2 (AHA color code)MP03417 ECG 5-lead C, grabber, 1m, dual pin connector, IEC1 (European color code)MP03418 ECG 5-lead C, grabber, 1m, dual pin connector, IEC2 (AHA color code)



Invasive Blood Pressure (IBP)

IBP accessories

Pulse Oximeter (SpO2)

LNCS Adhesive SpO2 Sensors

LNCS adhesive trauma sensors

LNCS Reusable SpO2 Sensors

5196998 Hemo pod adapter, Abbott/Medex/(Transtar) (One for each DualHemo and two for each QuadHemo/HemoMed pod)

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

NOTEAlways refer to the Directions for Use accompanying the Masimo patient accessories.

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

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 Neo PtBx20

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.

ROW PN USA PN Japan PN DescriptionMP00796 MP03019 MP03097 Masimo SpO2-Sensor LNCS DC-I



Assorted sensor accessories

MP00795 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 Description

ROW PN USA PN Japan PN Description7496933 MP03045 MP03147 SpO2 Posey Wrap Masimo 12pcs7496917 MP03046 MP03148 SpO2 Wrap for Masimo LNOP YI7496909 MP03047 MP03149 SpO2 Masimo Petite Wrap 100pcs7496875 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



RD SET adhesive SpO2 sensors

RD SET adhesive trauma sensors

RD SET reusable SpO2 sensors

RD SET adapter cables

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

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 ith 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



RD SET intermediate cables

Nellcor FLEXMAX reusable sensors

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 Masio 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,

internal volume 7 mL), 10 pcs.MP01063 etCO2 cuvette pediatrics, disposable (resistance 2.4 mbar at

30 L/min, internal volume 5 mL), 10 pcs.

PN 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 C.O. injectate thermistor cable1 PiCCO pod C.O. catheter cable1 PiCCO pod C.O. 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

PULSION disposable pressure transducers to the PiCCO Pod).MS16920 PULSION pressure transducer to PiCCO Pod interface cable

(Connects PULSION disposable pressure transducers to the adapter cable).

MS16919 PiCCO pod C.O. injectate thermistor cable (Connects the PiCCO PV4046 injectate sensor housing to the C.O. intermediate cable).

MS16918 PiCCO pod C.O. catheter cable (Connects the PiCCO arterial thermodilution catheter to the C.O. intermediate cable).

MS16916 PiCCO pod C.O. intermediate cable, 1.5 m (Connects the PiCCO C.O. catheter cable and C.O. thermistor cable to PiCCO pod).

NOTE: All disposables are delivered by PULSION directly.



Troubleshooting

Admission, Transfer, and Discharge

Admitting a Patient

Configuring the Menu Time Limit to OFF can obscure waveform data and other information while the Patient Admit menu remains active. Under this configuration, due to the lack of a menu timeout, as soon as the Patient Admit menu is no longer required, users should cancel the menu so that the monitor can display all information of monitored parameters.

Transferring Patient Data

The network patient transfer function from a Delta to an IACS is not supported when peripheral devices have been connected to the Delta through the MEDIBUS.X interface protocol.

When transferring a patient who has ST monitoring enabled from a Delta monitor to an M300 telemetry unit, only those ST parameters displayed on the Delta ST parameter box will have their ST trend data transferred to the M300.

Delta does not transfer the FiO2*/inO2 parameters when they originated from a Medibus.X device.

Discharging a Patient

When a patient is discharged from the Delta monitor and is placed on another Delta monitor, but the first monitor is not placed on a new patient, the Gateway may see the patient on two monitors: the Delta monitor that is in a discharge state and is not monitoring another patient, and the monitor that is currently monitoring the patient. This scenario may cause data exchange issues if the Delta monitor is interfaced to other information systems (e.g., electronic health record).

Alarms

Alarm Management

The monitor may not suppress disconnect-related messages without a validated clinical signal in situations that reset the monitor (e.g., changing units of measure, restore setup, power cycling). Acknowledging disconnect-related alarms (e.g., pressing Alarm Silence) removes these alarms.



Trends

Mini-Trends

When viewing Mini-Trend data and removing and re-connecting parameter cables (e.g., ECG MultiMed cable), allow the monitor 10 seconds to update Mini-Trend data so that the trend data color matches that of the monitored parameters.

ECG and Heart Rate

Status Messages

If an ECG Leads Invalid alarm remains displayed even though ECG leads are connected and the alarm has been acknowledged, disconnect and reconnect the ECG leads to clear the ECG Leads Invalid alarm.

Respiration

OxyCRG (OCRG) Monitoring

Do not disconnect and reconnect the Infinity etCO2 Microstream SmartPod when the OCRG menu is open, as the trim knob and hard keys may freeze for approximately 30 seconds. After the 30 seconds, the monitor resumes normal operation.

Cursor

In the OCRG screen, if inaccurate measurement values are suspected when a cursor rests on a point on a waveform, allow the OCRG screen to populate data for a full 3 minutes if the configured time duration is 3 minutes (or 6 minutes if the configured time duration is 6 minutes).

Accessing OxyCRG Review Summary Screen

When reviewing the OxyCRG Review Summary screen, if the event recall data appears unavailable, access the Event Recall screen directly via the Main Menu or Fast Access menus to determine if the data is truly unavailable.

Time Base

If the OCRG time base is changed (e.g., from 6 minutes to 3 minutes), the OCRG cursor time may be one minute ahead of the monitor's time. This issue is rectified upon patient discharge.

Recordings

If a timed recording is performed with OCRG so that an etCO2 or etCO2* waveform is printed, the etCO2/etCO2* waveform appears as a flat line in the middle of the grid. All etCO2-related numeric values are correct and available.



Pulse Oximetry (SpO2)

Quick Reference Table – SpO2 Setup

If double-pulsing occurs when Pulse Tone Volume is enabled under the SpO2 parameter menu, disable the pulse tone volume for SpO2 and enable the pulse tone volume in the ECG Options menu.

Dräger Mainstream etCO2 Monitoring

Precautions

Multiple CO2* Devices

In a multiple etCO2* devices situation involving MIB and Scio, it is recommended to physically disconnect the undesired device from the monitor.

When the message Duplicate Device Connected appears and if the CO2* waveform label disagrees with the parameters being monitored (e.g., the “CO2* module” waveform label displays when MIB is the active CO2* source device), disconnect one of the CO2* devices, wait a few second, then reconnect the CO2* source device.

NOTEIf a MultiGas parameter box appears after a Restore Setup with a Dräger mainstream CO2 module connected to the monitor, do the following:

1 Disconnect the Dräger mainstream CO2 module.

2 Connect a Scio module.

3 Disconnect the Scio module.

4 Reconnect the Dräger Mainstream CO2 module.

This procedure should remove the MultiGas parameter box.



Pulse Contour Cardiac Output (PiCCO) Monitoring

Pulse Contour Parameters and Thermodilution Setup Menus

On the Pulse Contour Parameters Setup Menu table and the Thermodilution Setup Menu table, the CVP Value Description and Available Settings are changed.

When performing a cardiac output calibration and the Manual CVP setting in the Pulse Contour setup menu is set to enabled, ensure 4 minutes have passed after initiating the calibration before entering a CVP value.

Peripheral Devices and Associated Software

Overview

If OSI OpticalCAM blood gas monitor pH values are interfaced into the monitor through MIB, the trended pH values are not available on the central station. This information is transferred over the network and through Gateway and, therefore, does not impact interfaced information systems. This trended information should be available directly from the blood gas analyzer or interfaced information systems.

Independent Surgical Display (ISD)

When MultiGas is turned off on the Delta, the ISD may display additional invalid waveforms and parameter fields. Refer to the primary source device for all diagnostic and therapeutic decisions.

If an ISD is used in the OR with PiCCO measurements, ensure that both the pulse contour and thermodilution parameter boxes are displayed on the ISD. This step prevents any resets of the ISD following a PiCCO measurement.

If you are using the Independent Surgical Display and it is configured for the display mode Monitor, make sure the setting MultiGas is enabled in the respective setup menu to ensure that the waveforms and values on the ISD appear correctly.

Menu Item Description Available Settings

CVP Value Allows user to select a CVP value.

NOTE: The auto CVP Value, if available, is used until the manual CVP Value menu is enabled. If auto CVP Value is unavailable or is out of range, a default of 5 mmHg is used.

5 mmHg (default)0 mmHg to 50 mmHg(in increments of 1 mmHg)


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This supplement only applies to Infinity Delta SW VF10.1 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

MS32649 – RI 05 en© Drägerwerk AG & Co. KGaAEdition: 5 – 2020-03(Edition: 1 – 2015-12)

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

Supplement Infinity Delta Series · Supplement – Infinity® Delta Series Software VF10.1 11...

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