Dräger Infinity Delta, Infinity Delta XL, Infinity Kappa Instructions For Use Manual
Instructions for Use
Infinity Delta Series
WARNING
To properly use this medical device, the
user must obtain a full understanding of
the performance characteristics of this
medical device prior to use by carefully
reading these Instructions for Use.
Infinity Patient Monitoring Series
Software VF8
Manufactured by:
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford, PA 18969-1042
Infinity Delta Series Instructions for Use
Software VF8
©Draeger Medical Systems, Inc.2010.
All rights reserved.
Printed in the United States of America.
This device bears the CE label in
accordance with the provisions of the
Directive 93/42/EEC of 14 June 1993
concerning medical devices (this label is
not applicable for US devices).
Distributed By:
Dräger Medical GmbH
Moislinger Alee 53-55
D-23558 Lübeck
Germany
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 Medical
GmbH.
All Dräger devices are intended for use by trained
medical personnel only.
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, MultiMed, Hemo2, Hemo4, Infinity, SmartPod,
Trident, Pick and Go, Scio, MicrO2+, and OxiSure are
registered trademarks of Dräger Medical GmbH.
PiCCO, PULSION, and PULSIOCATH are registered
trademarks of PULSION Medical Systems AG
CAPNOSTAT is a registered trademark of Novametrix
Medical Systems, Inc.
BIS and Bispectral Index are trademarks of Aspect
Medical Systems, Inc. and are registered in the USA, EU,
and other countries.
A-2000 and BISx are trademarks of Aspect Medical
Systems, Inc.
The Infinity BISx pod bears the CE label
in accordance with the provisions of the
Directive 93/42/EEC of 14 June 1993
concerning medical devices (this label is
not applicable for US devices).
The Infinity BISx pod is manufactured by:
Covidien
15 Hampshire St.
Mansfield, MA 02048
USA
Authorized EC representative:
Covidien Ireland Limited
IDA Business & technology Park
Tullamore, Ireland
Masimo, Masimo SET and Signal Extraction Technology
(SET) are registered trademarks of Masimo Corporation.
Nellcor is a registered trademark of Covidien
SILICON SOFTWARE © 1989, 90, 91, 92, 93, 94
Microtec Research Inc.
All rights reserved
Some graphics courtesy of Novametrix Medical Systems,
Inc.
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 Infinity etCO
bears the CE label in accordance with
the provisions of the Directive
93/42/EEC of 14 June 1993 concerning
medical devices.
The Infinity etCO
manufactured by:
Oridion Medical 1987 Ltd.
P.O. Box 45025
HaMarpe 7, Har-Hozvim
91450 Jerusalem
Israel
Authorized EC representative:
Obelis S. A.
Av. de Tevuren, 34 Bte 44
B-1040 Brussels
Belgium
Microstream is a registered trademark of Oridion Medical
2 Microstream pod
2 Microstream pod is
1987 Ltd.
All other brand or product names are trademarks or
registered trademarks of their respective companies.
2 Instructions for Use Delta/Delta XL/Kappa VF8
Overview
Intended Use ..................................................................................................................... 4
Indications for Use ........................................................................................................... 4
Intended Patient Categories ............................................................................................ 5
Documentation Features.................................................................................................. 5
Warnings, Cautions, Notes ....................................................................................5
Cross-references........................................................................................................5
Quick Reference Tables ............................................................................................5
Footer ..........................................................................................................................5
Applicability ................................................................................................................ 6
Safety Considerations...................................................................................................... 6
Site of Operation ........................................................................................................ 7
Inspection and Maintenance ..................................................................................... 8
Defibrillator Precautions .........................................................................................10
Pacemakers ..............................................................................................................11
Peripheral Devices ...................................................................................................11
Electrosurgery..........................................................................................................11
Electromagnetic Compatibility ......................................................................................13
Table of Contents ...........................................................................................................14
I
NFINITY DELTA SERIES USER’S GUIDE
Intended Use
The Infinity Delta Series (Delta/Delta XL/Kappa) Monitors are intended for multiparameter patient monitoring. The devices will produce visual and audible alarms if
any of the physiological parameters monitored vary beyond preset limits and timed or
alarm recordings will be produced. This device will connect to an R50 recorder, either
directly or via the Infinity Network.
NOTE: All Dräger hardware and screen shots shown in these Instructions for Use are
examples only. Actual product or screens may differ slightly.
Indications for Use
The Infinity Delta series monitors are capable of monitoring:
Heart rate
Respiration rate
Invasive pressure
Non-invasive pressure
Arrhythmia
Temperature
Cardiac output
Arterial oxygen saturation
Pulse rate
Apnea
ST segment analysis
12-lead ST segment analysis
tcpO2/tcpCO2
EEG signals
FiO
etCO
Respiratory mechanics
Anesthetic agents
Neuromuscular transmission
2
2
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INFINITY DELTA SERIES USER’S GUIDE
The devices are intended to be used in the environment where patient care is provided
by healthcare professionals, i.e. physicians, nurses, and technicians, who will
determine when use of the device is indicated, based on their professional assessment
of the patient’s medical condition.
Intended Patient Categories
The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on
adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac
Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult
and pediatric populations only; and tcpO
only be used when the patient is not under gas anesthesia.
, which for the neonatal population, is to
2
Documentation Features
Warnings, Cautions, Notes
WARNING! A WARNING statement provides important
information about a potentially hazardous situation which, if
not avoided, could result in death or serious injury.
CAUTION! A CAUTION statement provides important information about a potentially
hazardous situation which, if not avoided may result in minor or moderate injury to the
user or patient, or in damage to the equipment or other property.
NOTE: A note provides additional information intended to avoid inconvenience
during operation.
Cross-references
Cross-references specify chapter and page (for example, page 16-3 refers to chapter
16, page 3). The chapter number is given when text refers to an entire chapter (for
example, chapter 1).
Quick Reference Tables
Wherever possible, a quick reference table is provided for easy access to information
about monitor functions.
VF8 DELTA/DELTA XL/KAPPA 5
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NFINITY DELTA SERIES USER’S GUIDE
Footer
The current software version appears at the bottom of each page, together with the
chapter and page number and the device name.
Applicability
All references to “the monitor” in this manual refer to the Delta, Delta XL and Kappa
patient monitors. Model-specific information is documented as required.
NOTE: Software funtionality is identical between the following products:
Infinity Delta = Siemens SC 7000
Infinity Delta XL = Siemens SC 9000XL
Infinity Kappa = Siemens SC 8000
with the following exceptions as noted:
Alarm bar (see pages 1-5, 2-16, and 3-17).
Internal battery (see pages 1-15, 1-18, A-3, and B-8).
Size and weight (see page B-8).
Safety Considerations
These Instructions for Use assumes a working knowledge of patient monitors. To
support proper, safe and accurate operation of equipment, read all operating
instructions carefully before you use the monitor. The monitor complies with IEC
60601-1 and applicable collateral and particular standards.
WARNING: To maintain patient safety, adhere to all
WARNINGS and CAUTIONS listed in these Instructions for
Use and on equipment labels.
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INFINITY DELTA SERIES USER’S GUIDE
Site of Operation
Only use these devices in areas that meet the environmental requirements outlined in
the technical data section.
WARNING:
Do not operate the device in areas such as: magnetic
resonance imaging (MRI) environments, aircraft,
ambulance, home or hyperbaric chambers.
Do not operate devices (monitor, pods, modules and
accessories) in close proximity to equipment that emits
microwave or other high-frequency emissions since
they may interfere with the devices’ operation.
When placing the device make sure adequate
ventilation exists and prevent overheating by
positioning this device with at least 2 in (5 cm) of space
around all sides. Do not cover the devices with
blankets or bedsheets. To prevent burns to the patient
avoid direct contact between these items’ external
surfaces and the patient.
Only the items indicated on the list of accessories in
the “Approved Options and Accessories” chapter have
been tested and approved to be used with the device.
Accordingly it is strongly recommended that only these
accessories be used in conjunction with the specific
device. Otherwise the correct functioning of the device
may be compromised.
Disposable accessories (such as disposable
electrodes, transducers, etc.) are for single use only.
Do not reuse disposable accessories.
To minimize the risk of patient strangulation, carefully
position and secure sensor cables. Also carefully
position sensor cables to minimize inductive loops.
To avoid explosions, devices should not be used in the
presence of flammable anesthetic mixture including
oxygen, ether, nitrous oxide, and cyclopropane.
Because of the danger of electric shock, never remove
the cover of a device while it is in operation or
connected to power.
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CAUTION: To avoid short-circuiting and otherwise damaging the device, do not allow
fluids to come in contact with the device. If fluids are accidentally spilled on the
equipment, remove the affected unit from service as soon as possible and contact the
technical personnel to verify that patient safety is not compromised.
CAUTION: Before moving the patient, disconnect the patient from all sensors that will
not be used (to avoid patient injury).
CAUTION: Read all cleaning instructions (for example, originating from the
disinfectant manufacturer and the hospital) carefully before cleaning the device. Refer
to the “Cleaning and Disinfecting” chapter for device-specific cleaning instructions.
Moisture may damage the circuits, compromise critical performance and/or present a
safety risk.
Inspection and Maintenance
Regular inspection and maintenance of the monitoring system, its accessories and
its mounts are essential for maintaining patient safety. Failure by the responsible
individual, hospital or institution to follow the Service instructions may compromise
patient or caregiver safety and/or lead to device failure.
WARNING: If the monitor is mechanically damaged, or if it is
not working properly, do not use it. Contact your technical
personnel.
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INFINITY DELTA SERIES USER’S GUIDE
WARNING:
Repair of the device may only be carried out by trained
service personnel otherwise the correct functioning of
the device may be compromised. Regular annual
maintenance (functional and safety test) according to
IEC 62353 is recommended, in addition to national
regulations and laws (for example, accident prevention
regulations). Connecting this medical device to other
medical devices could result in additional maintenance
requirements. Consult the documentation for these
other devices to identify additional requirements.
Dräger recommends contracting with DrägerService for
any repairs. Use only authentic Dräger repair parts
during maintenance. Using non-Dräger repair parts may
adversely affect the operation of the device.
Contact your hospital’s technical personnel if the
monitor’s mounting mechanism appears mechanically
damaged or its structural integrity is compromised. Do
not mount the monitor under such circumstances.
Before docking, undocking or moving a monitor, verify that the mounting mechanism
is mechanically sound. Be careful not to apply too much force when docking the
monitor.
Verify that the safety labels are legible and the safety checks were performed at the
required interval.
Safety checks, verification, calibration and maintenance should be performed at least
every two years by properly trained personnel, as described in the Service manual (see
individual parameter chapters for information about calibration and verification of
parameter-specific functions and devices). All cables, alarm functions, accessories,
and associated devices should be checked for damage, ground resistance, chassis and
patient leakage currents on a yearly basis, or more frequently based on usage.
Maintain a record of these safety checks and other inspections.
NOTE:
The monitor’s service manual is available from your local DrägerService repre-
sentative.
Dispose of all equipment in accordance with local regulations.
VF8 DELTA/DELTA XL/KAPPA 9
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NFINITY DELTA SERIES USER’S GUIDE
Dräger recommends that:
Maintenance, modifications, and repairs are carried out by trained personnel.
Components are replaced with Dräger provided spare parts, otherwise the
correct functioning of the device may be compromised.
Devices are used in accordance with Dräger Instructions for Use.
General Electrical Safety
WARNING:
To protect the patient from possible injury due to
electrical shock:
Before putting a patient monitor into use, the installer
must verify that its leakage current meets the electrical
safety requirements of IEC 60601-1 and IEC 60601-1-1
(the safety standards for Medical Electrical Systems).
Connecting several medical devices to a patient
simultaneously increases the leakage current to which
that patient is exposed. Peripheral devices should only
be connected to a patient monitor within the same
room.
The installer or service provider should verify that the
interconnected system’s leakage currents meet the
electrical safety requirements mentioned above. The
installer or service provider should also verify that the
electrical safety classification of each device is
suitable for the intended application.
To avoid electric shock, inspect all cables before use.
Never use cables that appear cracked, worn, or
damaged in any way (doing so may compromise
performance or put the patient at risk).
To ensure that the device is properly grounded,
connect the AC adapter, communication power supply
module, and IDS power supply to a hospital-grade
outlet.
CAUTION: To avoid injuring the patient, do not touch any connector or mounting
screw on the device when you are touching the patient. Do not allow the conductive
parts of electrodes and cables to ever contact other conductive parts or ground, either.
NOTE: The potential equalization terminal can help ensure that a voltage difference
does not exist between multiple pieces of equipment.
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INFINITY DELTA SERIES USER’S GUIDE
Defibrillator Precautions
The monitor and peripheral devices are protected against high-frequency interference
from defibrillators and electrosurgical units and against 50- and 60-Hz power line
interference. Following defibrillation, the monitor begins displaying waveform data
again within 10 seconds if the correct electrodes are used and those electrodes are
applied in accordance with the manufacturer’s instructions.
CAUTION:
Only defibrillate across the chest.
To avoid potentially re-routing electrical current through electrodes, thus
causing burns and electric shock, do not position the defibrillator pads near
any electrodes or sensors.
To protect the monitor from damage during defibrillation, for accurate ECG
information, and to protect against noise and other interference, use only ECG
electrodes and cables specified by Dräger.
Pacemakers
NOTE: See the section “Pacemakers” on page 8-3 for safety precautions when
monitoring paced patients.
Peripheral Devices
NOTE: See the section “Precautions” on page 28-5 for safety precautions when using
a Medical Information Bus (MIB) protocol device or the Independent Surgical Display.
WARNING: Electrical connections to equipment which is not
listed in these Instructions for Use should only be made
following consultation with the respective manufacturer.
Electrosurgery
To support user and patient safety and to reduce electro-surgical unit (ESU)
interference, observe the following precautions during electrosugery.
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NFINITY DELTA SERIES USER’S GUIDE
WARNING:
The NeoMed and MultiMed 12 pods are not intended for
use during electrosurgery. To protect patients from
burns, do not use these pods in an ESU environment.
For better performance and to reduce the hazard of
burns during surgery, always use accessories designed
for ESU environments.
To reduce the hazard of burns during surgery, keep the
sensor or transducer (ECG, temperature, pressure,
SpO
, BISx) and their associated cables away from the
2
surgical site, the electro-surgical unit return electrode,
and earth ground.
Always use a Dräger ESU block or MultiMed Plus OR
cable with compatible lead wires. Doing so reduces
ESU interference and protects the patient from burns
caused by ESU-induced current flowing through the
lead wires. For better performance, also set the ECG filter option to ESU.
Dräger recommends using the ESU block during
electrosurgery. If you do not have an ESU block or a
MultiMed Plus OR, use only Dräger blue ECG lead sets.
They help protect the patient from burns caused by
ESU-induced current flowing through the leads.
While the ESU block or the MultiMed Plus OR cable are
in use, impedance respiration monitoring is inoperative
and the detection of pacemaker spikes is degraded. If
pacemaker detection is enabled, the ESU interference
may be detected as pacemaker spike.
Dräger recommends the use of the MultiMed Plus OR
during electrosurgery only.
Do not use the MultiMed Plus OR cable with Dräger blue
ECG lead wires. Doing so, will degrade performance
which can result in inaccurate values.
NOTE:
Use SpO
Use rectal temperature probe sheaths to cover internally placed temperature
instead of the ECG parameter to determine heart rate.
2
sensors.
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INFINITY DELTA SERIES USER’S GUIDE
Electromagnetic Compatibility
The monitor has been designed and tested for compliance with current regulatory
standards (IEC 60601-1-2 and CISPR 11 Class B) regarding its capacity to reduce
electromagnetic emissions (EMI) and to block EMI from external sources.
Dräger recommends these procedures to reduce electromagnetic interference:
Use only Dräger provided accessories, otherwise the correct functioning of
the device may be compromised (see appendix C).
Ensure that other products in patient-monitoring and/or life-support areas
comply to accepted emissions standards (CISPR 11, Class B).
Maximize distance between electro medical devices. High-power devices
relating to electrocautery, electrosurgery, and radiation (X-ray), as well as
electrical stimulators and evoked potential devices, may produce interference
on the monitor.
Strictly limit access to portable radio-frequency sources (e.g., cellular phones
and radio transmitters). Portable phones may periodically transmit even when
in standby mode.
Maintain good cable management. Avoid routing cables over electrical
equipment. Do not intertwine cables.
Ensure electrical maintenance is done by qualified personnel.
NBP and sidestream etCO
Microstream® pod) use motors that emit very low-level electromagnetic fields
that may interfere with other sensitive medical devices.
For more information on Electromagnetic Compatibility, see page B-3.
monitors and pods (except for the Infinity etCO
2
2
VF8 DELTA/DELTA XL/KAPPA 13
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NFINITY DELTA SERIES USER’S GUIDE
Table of Contents
Overview
Intended Use ....................................................................................................................4
Indications for Use .......................................................................................................... 4
Intended Patient Categories ........................................................................................... 5
Documentation Features ................................................................................................ 5
Safety Considerations ..................................................................................................... 6
Electromagnetic Compatibility ..................................................................................... 13
Table of Contents .......................................................................................................... 14
Introduction
Overview ........................................................................................................................1-2
Power Sources (Delta/Delta XL) ................................................................................1-13
Power Sources (Kappa) .............................................................................................1-17
Getting Started ............................................................................................................1-19
Menu Access ...............................................................................................................1-21
Data Archive Applications ......................................................................................... 1-24
Help Functions ............................................................................................................1-27
Monitor Setup
Overview ........................................................................................................................2-2
Configuring the Monitor ............................................................................................... 2-2
Setups Management ..................................................................................................... 2-9
Specialty Menus .........................................................................................................2-12
Software Upgrades ..................................................................................................... 2-24
Network Applications
Overview ........................................................................................................................3-2
Connecting to the Network ..........................................................................................3-3
Pick and Go Transport (Delta/Delta XL only) .............................................................3-5
Infinity Explorer Support .............................................................................................3-6
Wireless Network ..........................................................................................................3-6
Network Transfer ........................................................................................................ 3-12
Remote View ............................................................................................................... 3-13
Privacy .........................................................................................................................3-16
Admission, Transfer, and Discharge
Overview ........................................................................................................................4-2
14 DELTA/DELTA XL/KAPPA VF8
INFINITY DELTA SERIES USER’S GUIDE
Admitting a Patient ....................................................................................................... 4-2
Transferring Patient Data .............................................................................................4-3
Discharging a Patient ................................................................................................... 4-7
Alarms
Overview.........................................................................................................................5-2
Alarm Priorities..............................................................................................................5-3
Alarm Latching ..............................................................................................................5-5
Alarm Management .......................................................................................................5-5
Alarm Setup (Alarm Limits Table)................................................................................5-6
Alarm History Table.....................................................................................................5-14
OR Alarms ....................................................................................................................5-15
Trends
Overview ........................................................................................................................6-2
Trend Setup ...................................................................................................................6-2
Trend Graphs ................................................................................................................6-3
Trend Table ...................................................................................................................6-6
Mini-Trends ...................................................................................................................6-7
Recordings
Overview ........................................................................................................................7-2
Recordings ....................................................................................................................7-2
Recorder Setup .............................................................................................................7-8
Print Screen ...............................................................................................................7-11
Reports ........................................................................................................................7-11
Status Messages ........................................................................................................7-13
ECG and Heart Rate
Overview ........................................................................................................................8-2
ECG Precautions ..........................................................................................................8-3
Patient Preparation .......................................................................................................8-8
ECG Leads ..................................................................................................................8-14
ECG Signal Processing and Display ........................................................................ 8-15
Alarms and Alarm Conditions ...................................................................................8-16
ECG Setup Menu ........................................................................................................8-17
Status Messages ........................................................................................................8-23
Arrhythmia Monitoring
Overview ........................................................................................................................9-2
VF8 DELTA/DELTA XL/KAPPA 15
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NFINITY DELTA SERIES USER’S GUIDE
About the Arrhythmia Template ..................................................................................9-3
Arrhythmia Setup .........................................................................................................9-5
Status Messages ..........................................................................................................9-9
ST Monitoring
Overview ......................................................................................................................10-2
MultiMed Pods for ST Analysis .................................................................................10-3
ST Display ...................................................................................................................10-4
ST Analysis Setup ...................................................................................................... 10-4
ST Alarms Table .......................................................................................................10-10
Status Messages .....................................................................................................10-11
EEG Monitoring
Overview ......................................................................................................................11-2
Precautions ................................................................................................................. 11-2
Connecting the EEG Pod ........................................................................................... 11-3
EEG Setup ...................................................................................................................11-6
Status Messages ........................................................................................................11-9
Respiration
Overview ......................................................................................................................12-2
RESP Precautions ......................................................................................................12-3
Patient Preparation .....................................................................................................12-4
Display Features ......................................................................................................... 12-5
RESP Setup Menu ......................................................................................................12-6
OxyCRG (OCRG) Monitoring ..................................................................................... 12-9
Status Messages ......................................................................................................12-18
Non-Invasive Blood Pressure
Overview ......................................................................................................................13-2
Display Features ......................................................................................................... 13-2
NBP Setup ................................................................................................................... 13-3
Status Messages ......................................................................................................13-13
Invasive Blood Pressure
Overview ......................................................................................................................14-2
Precautions ................................................................................................................. 14-3
Hardware Setup .......................................................................................................... 14-3
Display Features ....................................................................................................... 14-11
IBP Setup ...................................................................................................................14-13
16 DELTA/DELTA XL/KAPPA VF8
INFINITY DELTA SERIES USER’S GUIDE
Pulmonary Wedge Pressure Display ..................................................................14-18
Status Messages ......................................................................................................14-20
Cardiac Output (C.O.)
Overview ......................................................................................................................15-2
Accuracy .....................................................................................................................15-3
Main Screen Display ...................................................................................................15-4
C.O. Setup - Hardware ................................................................................................ 15-5
C.O. Measurement Procedures ...............................................................................15-10
Averaging C.O. Measurements ...............................................................................15-12
Status Messages ......................................................................................................15-14
Calculations
Overview ......................................................................................................................16-2
Physiological Calculations (Hemo/Oxy/Vent Calculations) ....................................16-3
Hemodynamic Calculations (Hemo-Calcs) ............................................................16-10
Drug Calculations ..................................................................................................... 16-12
Pulse Oximetry (SpO2)
Overview ......................................................................................................................17-2
Precautions ................................................................................................................. 17-2
Hardware Setup .......................................................................................................... 17-4
Patient Preparation .....................................................................................................17-7
Display Features ......................................................................................................... 17-8
SpO2 Setup .................................................................................................................17-8
Status Messages ......................................................................................................17-10
MicrO2+® Standalone Pulse Oximeter ...................................................................17-19
Transcutaneous Blood Gas Monitoring
Overview ......................................................................................................................18-2
Precautions ................................................................................................................18-3
Patient Preparation .....................................................................................................18-4
Hardware .....................................................................................................................18-5
Display Features ....................................................................................................... 18-10
tpO2/CO2 Setup ........................................................................................................18-10
Status Messages ......................................................................................................18-14
etCO2 (End-Tidal CO2) monitoring
Overview ......................................................................................................................19-2
General etCO2/Gas Analysis Precautions ...............................................................19-4
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Sampling Methods ...................................................................................................... 19-6
Display Features ......................................................................................................... 19-9
etCO2 Setup .............................................................................................................. 19-11
Cleaning, Calibration and Verification ....................................................................19-14
Status Messages ......................................................................................................19-16
Microstream® etCO2 Monitoring
Overview ......................................................................................................................20-2
Precautions ................................................................................................................. 20-2
Connection .................................................................................................................. 20-3
etCO2 Display Features .............................................................................................20-4
etCO2 Setup ................................................................................................................ 20-6
Calibration ................................................................................................................... 20-7
Status Messages ........................................................................................................20-8
Respiratory Mechanics
Overview ......................................................................................................................21-2
Precautions ................................................................................................................. 21-2
Hardware Setup .......................................................................................................... 21-4
Paw and Vent Setup Menus .......................................................................................21-7
Display Features ....................................................................................................... 21-10
Alarms .......................................................................................................................21-24
Cleaning and Calibration .........................................................................................21-24
Status Messages ......................................................................................................21-24
FiO2 (Fractional Inspired O2) monitoring
Overview ......................................................................................................................22-2
Precautions ................................................................................................................. 22-2
Display Features ......................................................................................................... 22-3
FiO2 Setup ...................................................................................................................22-3
Status Messages ........................................................................................................22-6
Scio® Four Modules
Overview ......................................................................................................................23-2
Precautions ................................................................................................................. 23-5
Hardware Setup .......................................................................................................... 23-7
Scio Setup ................................................................................................................. 23-12
Maintenance and Repair ..........................................................................................23-24
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Neuromuscular Transmission (NMT) monitoring
Overview ......................................................................................................................24-2
Precautions ................................................................................................................. 24-3
Connections ................................................................................................................ 24-4
Monitoring Modes .......................................................................................................24-5
Taking NMT Measurements .......................................................................................24-6
Status Messages ........................................................................................................24-9
Bispectral Index (BISx) monitoring
Overview ......................................................................................................................25-2
Precautions ................................................................................................................. 25-2
Patient Preparation .....................................................................................................25-3
Display Features ......................................................................................................... 25-3
BIS Setup ....................................................................................................................25-5
Checking the Impedance ...........................................................................................25-8
Status Messages ........................................................................................................25-9
Pulse Contour Cardiac Output (PiCCO) monitoring
Overview ......................................................................................................................26-2
Precautions ................................................................................................................. 26-6
PiCCO Setup including IBP .......................................................................................26-8
Averaging p-CO Measurements ..............................................................................26-12
Display Features ....................................................................................................... 26-15
PiCCO Parameter Setup ........................................................................................... 26-16
Optimizing Results for PiCCO Measurements .......................................................26-23
Status Messages .....................................................................................................26-26
Body Temperature
Overview ......................................................................................................................27-2
Temperature Display .................................................................................................. 27-4
Temperature Setup ..................................................................................................... 27-6
Status Messages ........................................................................................................27-6
Peripheral Devices
and Associated Software
Overview ......................................................................................................................28-2
Precautions ................................................................................................................. 28-5
Ventilation and Anesthesia Devices ........................................................................28-6
Open Lung Tool ........................................................................................................28-12
Primus, Zeus and Apollo Anesthesia Devices .......................................................28-14
VF8 DELTA/DELTA XL/KAPPA 19
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SvO2/CCO Monitors ................................................................................................. 28-17
Radiometer MicroGas 7650 Monitor ..................................................................... 28-19
Aspect A-2000 BIS“ Monitor ....................................................................................28-19
Independent Surgical Display (ISD) ........................................................................28-20
MIB Status Messages ............................................................................................... 28-23
Dräger Infant Incubator C2000/C2000e ................................................................... 28-24
Dräger Infant Incubator Caleo .................................................................................28-27
Dräger Babytherm Infant Warmer ...........................................................................28-30
Somanetics INVOS Cerebral/Somatic Oximeter 5100C ........................................ 28-33
Cleaning and Disinfecting
Overview ......................................................................................................................29-2
ECG ..............................................................................................................................29-3
NBP ..............................................................................................................................29-4
IBP ................................................................................................................................29-4
SpO2 ............................................................................................................................29-6
Trident (NMT) Pod ......................................................................................................29-7
etCO2 and Respiratory Mechanics ........................................................................... 29-7
FiO2 ............................................................................................................................29-11
Temperature .............................................................................................................. 29-12
Glossary.................................................................................................................. A-1
Technical Data
Overview .......................................................................................................................B-3
Overall Regulatory Standard Compliance ................................................................. B-3
Electromagnetic Compatibility (EMC) ....................................................................... B-3
System Components ................................................................................................... B-8
Displays ...................................................................................................................... B-18
Monitoring Accessories ............................................................................................ B-21
Monitoring Specifications ......................................................................................... B-33
Approved Options and Accessories
Power Supply................................................................................................................ C-3
External Connection Accessories .............................................................................. C-6
Displays and Display Components............................................................................. C-9
Monitor Options........................................................................................................... C-9
ECG.............................................................................................................................. C-10
Pulse Oximetry (SpO2) .............................................................................................. C-14
Temperature................................................................................................................ C-17
Non-Invasive Blood Pressure (NBP)......................................................................... C-18
20 DELTA/DELTA XL/KAPPA VF8
INFINITY DELTA SERIES USER’S GUIDE
Pulse Contour Cardiac Output (PiCCO) ................................................................... C-19
Invasive Blood Pressure (IBP) .................................................................................. C-20
Cardiac Output ........................................................................................................... C-23
Transcutaneous Blood Gas....................................................................................... C-24
End-Tidal CO2 (etCO2)............................................................................................... C-24
etCO2/Respiratory Mechanics................................................................................... C-26
FiO2.............................................................................................................................. C-26
MultiGas Monitoring................................................................................................... C-27
NMT Monitoring ......................................................................................................... C-28
BISx Monitoring ......................................................................................................... C-29
EEG .............................................................................................................................. C-29
Pod Communication................................................................................................... C-29
VF8 DELTA/DELTA XL/KAPPA 21
I
NFINITY DELTA SERIES USER’S GUIDE
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22 DELTA/DELTA XL/KAPPA VF8
1 Introduction
Overview.........................................................................................................................1-2
Overview (Delta/Delta XL).......................................................................................1-2
Overview (Kappa)....................................................................................................1-3
System Components .............................................................................................1-4
Base Unit..................................................................................................................1-5
Kappa Video Display.............................................................................................1-10
Device Markings....................................................................................................1-11
Auxiliary Display and Other Components ..........................................................1-12
Power Sources (Delta/Delta XL) .................................................................................1-13
Infinity Docking Station (IDS)...............................................................................1-14
Battery Power ........................................................................................................1-14
Power Sources (Kappa) ..............................................................................................1-17
Getting Started.............................................................................................................1-19
Accessing the Main Screen..................................................................................1-19
Using the Rotary Knob .........................................................................................1-20
Remote Keypad .....................................................................................................1-21
Menu Access................................................................................................................1-21
Fast Access Menu.................................................................................................1-22
Main Menu..............................................................................................................1-22
Fixed Keys .............................................................................................................1-23
Control Buttons.....................................................................................................1-23
Data Archive Applications ..........................................................................................1-24
Storing Events.......................................................................................................1-25
Event Recall...........................................................................................................1-26
Navigating the Event Recall Screen ....................................................................1-27
Help Functions.............................................................................................................1-27
1 I
NTRODUCTION
Overview
The patient monitor is intended for adult, pediatric, and neonatal monitoring. It can be
used as a standalone device or can be connected to the Infinity network. Monitor use is
restricted to one patient at a time.
The following optional software features are available:
ACE full arrhythmia (Arrhythmia II)
Hemodynamic & oxygenation/ventilation calculations (physiological
3-lead ST segment analysis
Waveform channel upgrades (Kappa only: 4 channels to 5 channels. Delta/
Aries (Advanced Review of Ischemia Event System)
One PodCom connection is standard on the Delta monitor, a second PodCom
MIB (Kappa only: Advance Communication. Delta/Delta XL only: MIB II 1
calculations)
Kappa only: 5 channels to 6 channels. Delta/Delta XL/Kappa: 6 channels to 8
channels)
connection is optional. Two PodCom connections are standard on the Kappa
Delta XL. Three PodCom connections are available on Kappa.
to 4 Option for IDS)
Wireless Networking
OR mode (for the IDS and/or monitor)
NOTE: After connecting various sensors, make sure that each sensor's parameter data
such as values and a waveform (if applicable) appear on the monitor screen.
Overview (Delta/Delta XL)
The Pick and Go feature allows you to disconnect the Delta or Delta XL monitor from
the network and transport both monitor and patient to another location; you do not
have to discharge the patient and admit him or her at another monitor. You can
therefore not only save valuable time but maintain continuous monitoring during
patient transport. At any time, you can reconnect (redock) the portable monitor to the
network via the Docking Station or the Infinity Docking Station.
1-2 DELTA/DELTA XL/KAPPA VF8
Overview (Kappa)
The basic Kappa monitoring system consists of two components: a processing CPU
base unit and a display unit. These Instructions for Use use the word “Kappa” monitor
to refer to the CPU base unit, unless otherwise specified. The Kappa is designed to
operate with a separate large screen display.
The monitor displays trended data in graphical and tabular trends.
Kappa Monitoring System
Display unit
1
Kappa base unit
2
OVERVIEW
VF8 DELTA/DELTA XL/KAPPA 1-3
1 I
NTRODUCTION
System Components
NOTE:
For a complete list of accessories available with this product, see Appendix C.
The monitor configuration may vary. Refer to your hospital’s technical
personnel for more information.
The parts below include standard and optional components.
The Delta or Delta XL requires:
Monitor
Power supply
Country specific power cord and monitor
MultiMed or NeoMed cables
Optional: Infinity Docking Station (IDS) for mounting, power, and
networking capabilities
The Kappa requires:
Monitor front end
Country specific power cord
A display unit
MultiMed or NeoMed cables
Applicable Software Options (on a memory option card) include:
Options for Delta only:
Delta second PodPort option
Options for Kappa only:
Kappa 4 to 5 channel option
Kappa advanced communication option II
Delta and Kappa only:
Delta and Kappa 5 to 6 channel option
Delta and Delta XL only:
OR Mode option (loaded in the IDS)
1-4 DELTA/DELTA XL/KAPPA VF8
Delta, Delta XL and Kappa:
Delta/Delta XL MIB II 1 to 4 option for IDS/ Kappa - advance
communication
6 to 8 channel option
3-Lead ST analysis option
Wireless networking option
ARIES option
Physio calculations option
ACE full arrhythmia option
ARIES/Physio Calcs/ACE arrhythmia option package
OR mode option (loaded in the monitor)
Base Unit
Monitor Front View – Delta
OVERVIEW
1
2
3
4
5
6
Fixed keys
Main menu fixed key
Main screen fixed key
Battery charge indicator
Power switch
Alarm bar (not available
on SC 7000)
VF8 DELTA/DELTA XL/KAPPA 1-5
1 I
NTRODUCTION
Monitor Front View – Delta XL
Monitor Front View – Kappa
1
Fixed keys
1
2
3
4
5
6
HemoMed connector
Fixed keys
Main menu fixed key
Main screen fixed key
Battery charge indicator
Power switch
2
3
4
5
Rotary knob
Analog (balloon pump)/sync
(QRS sync defib) connector
NBP hose connector
Auxiliary PodCom connector
7
8
9
Connectors for Aux/Hemo or
PodCom
MultiMed connector
Cable strain relief
1-6 DELTA/DELTA XL/KAPPA VF8
Monitor Rear View – Delta
Monitor Rear View – Delta XL
External (lead-acid) battery
1
compartment
Connector for docking station/
2
interface plate
Connector for AC adaptor
3
Slot for etCO2 module
4
External (lead-acid) battery
1
compartment
Connector for docking station/
2
interface plate
OVERVIEW
Connector for AC adapter
3
Slot for etCO2 module
4
VF8 DELTA/DELTA XL/KAPPA 1-7
1 I
NTRODUCTION
Monitor Rear View – Kappa
Analog out / Sync (balloon pump/
1
defibrillator) (X10)
Alarm output (nurse call)1, export
2
protocol (X5)
Recorder output (X13) 8 Infinity network connector (X14)
3
Video out (VGA) (X16) 9 Potential equalization
4
RS232 connector, Scio module, Smart
5
Pod, remote keypad, Vital Connect
Cable (VCC), Alarm output (nurse
call)2 – (X8)
1
NOTE: Alarm output (nurse call) requires the alarm output cable with partnumber 5194928.
2
NOTE: Alarm output (nurse call) requires the alarm output cable with partnumber 4314626.
QRS Sync (for example, for defibrillator
6
connection)
7 PCMCIA slot (“Memory card”)
10 AC input
Monitor Left Side – Delta
HemoMed connector
1
Connectors for Aux/Hemo or PodCom
2
MultiMed connector
3
NBP connector
4
1-8 DELTA/DELTA XL/KAPPA VF8
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