Infinity Delta Series V8 Instructions for Use

Page 1

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

Page 2

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 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 etCO2 Microstream pod

bears the CE label in accordance with

the provisions of the Directive

93/42/EEC of 14 June 1993 concerning

medical devices.

The Infinity etCO2 Microstream pod is

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

1987 Ltd.

All other brand or product names are trademarks or

registered trademarks of their respective companies.

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).

2

Instructions for Use Delta/Delta XL/Kappa VF8

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INFINITY 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

FiO2

etCO2

Respiratory mechanics

Anesthetic agents

Neuromuscular transmission

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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 tcpO2, which for the neonatal population, is to

only be used when the patient is not under gas anesthesia.

Documentation Features

Warnings, Cautions, Notes

WA R N I N G ! A WA R N I N G s ta t e m e n t p r o v i d e s i m p o r ta n t

information about a potentially hazardous situation which, if

n o t a v o i d e d, c o u l d re s u l t i n d e a t h o r s e r i o u s i n j u r y.

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.

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INFINITY 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.

WA R N I N G : To m a i n ta i n pa t i e nt s a f e t y, a d h e r e t o a l l

WA R N I N G S a n d C A U T I O N S l i s t e d i n t h e s e I n s t r u c t i o n s f o r

Use and on equipment labels.

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Site of Operation

Only use these devices in areas that meet the environmental requirements outlined in

the technical data section.

WA R N I N G :

Do not operate the device in areas such as: magnetic

r e s o n a n c e i m a g i n g ( M R I ) e nv i r o n m e n ts , a i r c r a ft ,

a mb u l a n c e , h o m e o r h y p e rb a ri c c h a mb e r s .

D o n o t o p e r a t e d e v i c e s ( m o n i t o r, p o d s , m o d u l e s a n d

a c c e s s o r i e s ) i n c l o s e p r o x i m i t y t o e qu i p m e n t t h a t e m i ts

microwave or other high-frequency emissions since

they may interfere with the devices’ operation.

W h e n p l a c i n g t h e d e v i c e m a k e s u r e a d e qu a t e

v e n t i l a t i o n e x i s ts a n d p re v e n t o v e rh e a t i n g b y

p o s i t i o n i n g t h i s d e v i c e w i t h a t l e a s t 2 i n ( 5 c m ) o f s pa c e

a ro u n d a l l s i d e s . D o n o t c o v e r t h e d e v i c e s w i t h

b l a n k e ts o r b e d s h e e ts . To p re v e n t b u r n s t o t h e pa t i e nt

a v o i d d i r e c t c o n ta c t b e t w e e n t h e s e i t e ms ’ e x t e rn a l

s u r f a c e s a n d t h e pa t i e n t .

O nl y t h e i t e m s i n d i c a t e d o n t h e l i s t o f a c c e s s o r i e s i n

the “Approved Options and Accessories” chapter have

b e e n t e s t e d a n d a pp ro v e d t o b e u s e d w i t h t h e d e v i c e .

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

e l e c t r o d e s , t r a n s du c e r s , e t c . ) a r e f o r s i n g l e u s e o n l y.

Do not reuse disposable accessories.

To m i n i m i z e t h e r i s k o f pa t i e n t s t r a n g u l a t i o n , c a r e f ul l y

position and secure sensor cables. Also carefully

p o s i t i o n s e n s o r c a b l e s t o m i n i m i z e i n d u c t i v e l o o ps .

To a v o i d e x p l o s i o n s , d e v i c e s s h o u l d n o t b e u s e d i n t h e

p re s e n c e o f f l a m m a b l e a ne s t h e t i c m i x t u re i n c l u d i n g

o x y g e n , e t h e r, n i t r o u s o x i d e , a n d c y c l o p r o pa n e .

B e c a u s e o f t h e d a n ge r o f e l e c t r i c s h o c k , n e v e r r e m o v e

the cover of a device while it is in operation or

c o n n e c t e d t o p o w e r.

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INFINITY DELTA SERIES USER ’S GUIDE

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.

WA R N I N G : I f t h e m o n i t o r i s m e c h a n i c a l l y d a m a g e d , o r i f i t i s

n o t w o r k i n g p r o p e rl y, d o n o t u s e i t . C o n ta c t y o u r t e c h n i c a l

personnel.

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WA R N I N G :

R e pa i r o f t h e d e v i c e m a y o n l y b e c a r ri e d o u t b y t r a i n e d

service personnel otherwise the correct functioning of

t h e d e v i c e m a y b e c o m p r o m i s e d . R e g ul a r a n n u a l

m a i n t e n a n c e ( f u n c t i o na l a n d s a f e t y t e s t ) a c c o r d i n g t o

IEC 62353 is recommended, in addition to national

r e g u l a t i o ns a n d l a w s ( f o r e x a m p l e , a c c i d e n t p re v e n t i o n

regulations). Connecting this medical device to other

medical devices could result in additional maintenance

r e q u i r e me nts . C o n s u l t t h e d oc um e n ta t i o n f o r t h e s e

o t h e r d e v i c e s t o i d e n t i f y a d d i t i o n a l r e q u i r e m e n ts .

D r ä g e r r e c o m m e n ds c o n t r a c t i n g w i t h D r ä ge r S e r v i c e f o r

a n y r e pa i r s . U s e o nl y a ut h e n t i c D r ä g e r r e pa i r pa r ts

d ur i n g ma i n t e n a n c e . U s i n g n o n - D rä g e r re pa i r pa r ts ma y

a d v e r s e l y a f f e c t t h e o p e r a t i o n o f t he d e v i c e .

C o n ta c t y o u r h o s p i ta l ’s t e c h n i c a l p e r s o n n e l i f t h e

m o n i t o r ’s m o u n t i n g m e c h a n i s m a p p e a rs m e c h a n i c a l l y

d a m a g e d o r i ts s t r u c t u r a l i n t e g r i t y i s c o m p r o m i s e d . D o

n o t m o u nt t he m o n i t o r u n d e r s u c h c i r c u m s ta nc e s .

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 representative.

Dispose of all equipment in accordance with local regulations.

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INFINITY 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

WA R N I N G :

To p r o t e c t t h e pa t i e n t f r o m p o s s i b l e i n j u r y d ue t o

electrical shock:

B e f o r e p u t t i n g a pa t i e n t m o n i t o r i n t o u s e , t h e i n s ta l l e r

m u s t v e r i f y t ha t i ts l e a k a g e c ur r e n t m e e ts t h e e l e c t r i c a l

s a f e t y r e q ui r e m e n ts o f I E C 6 0 6 0 1 - 1 a n d I E C 6 0 6 0 1 - 1 - 1

( t h e s a f e t y s ta nd a r d s f o r M e d i c a l E l e c t r i c a l S y s t e m s ) .

C o n n e c t i n g s e v e r a l m e d i c a l d e v i c e s t o a pa t i e n t

s i m u l ta n e o u s l y i n c r e a s e s t h e l e a k a g e c u r r e n t t o w h i c h

t h a t pa t i e n t i s e x p o s e d . P e r i p h e r a l d e v i c e s s h o u l d o n l y

b e c o n n e c t e d t o a pa t i e n t m o n it or w i t h i n t h e s a m e

r o o m.

T h e i n s ta l l e r o r s e r v i c e p ro v i d e r s h o u l d v e r i f y t h a t t h e

i n t e r c o n n e c t e d s y s t e m ’s l e a k a g e c u r r e n ts m e e t t h e

e l e c t r i c a l s a f e t y r e q ui r e m e n ts m e n t i o n e d a bo v e . T he

i n s ta l l e r o r s e r v i c e p ro v i d e r s h o u l d a l s o v e r i f y t h a t t h e

electrical safety classification of each device is

s u i ta b l e f o r t he i n t e n d e d a p p l i c a t i o n .

To a v o i d e l e c t r i c s h o c k , i n s p e c t a l l c a b l e s b e f o r e u s e .

N e v e r u s e c a b le s t h a t a p p e a r c r a c k e d , w or n , o r

damaged in any way (doing so may compromise

p e r f o r m a n c e o r p u t t h e pa t i e n t a t r i s k ) .

To e n s u r e t h a t t h e d e v i c e i s p r o p e r l y g ro u n d e d ,

c o n n e c t t h e A C a d a p t e r, c o m m u n i c a t i o n p o w e r s u p p l y

m o d u l e , a n d I D S p o w e r s u p p l y t o a h o s p i ta l - g r a d e

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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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.

WA R N I N G : E l e c t r i c a l c o n n e c t i o n s t o e q u i p m e n t w h i c h i s n o t

listed in these Instructions for Use should only be made

f o l l o w in g c on s ul ta t i o n w i t h t he re s pe c t i v e m a n uf a c t u re r.

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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WA R N I N G :

The NeoMed and MultiMed 12 pods are not intended for

u s e d ur i n g e l e c t r o s ur g e r y. To p ro t e c t pa t i e n ts f r o m

b u r n s , d o n ot u s e t h e s e p o d s i n a n E S U e n v i r o n m e n t .

F o r b e t t e r p e r f o r ma n c e a n d t o r e d u c e t h e h a z a r d o f

b u r n s d u r i n g s u r g e r y, a l w a y s u s e a c c e s s o r i e s d e s i g n e d

f o r E S U e n v i ro n m en ts .

To r e d u c e t h e h a z a r d o f b u r n s d u r i n g s u r g e r y, k e e p t h e

s e n s o r o r t r a n s d u c e r ( E C G, t e m p e ra t u re , p r e s s u r e ,

Sp O 2, B I S x ) a nd t h e i r a s s o c i a t e d c a b l e s a w a y f r o m t h e

surgical site, the electro-surgical unit return electrode,

and earth ground.

Always use a Dräger ESU block or MultiMed Plus OR

c a b l e w i t h c o m pa t i b l e l e a d w i r e s . D o i n g s o r e d u c e s

E S U i n t e r f e r e n c e a n d p ro t e c ts t h e pa t i e n t f r o m b u r n s

caused by ESU-induced current flowing through the

l e a d w i r e s . F or b e t t e r p e r f o r m a n c e , a l s o s e t t h e E C G f i l ter option to ESU.

Dräger recommends using the ESU block during

e l e c t r o s u r g e r y. I f y o u d o n o t h a v e a n E S U b l o c k o r a

M u l t i M e d P l u s O R , u s e o n l y D r ä g e r b l u e E C G l e a d s e ts .

T h e y h e l p p r o t e c t t h e pa t i e n t f r o m b u r n s c a u s e d b y

E S U - i n d u c e d c u r r e n t f l o w i n g t hr o u g h t h e l e a ds .

While the ESU block or the MultiMed Plus OR cable are

in use, impedance respiration monitoring is inoperative

a n d t h e d e t e c t i o n o f pa c e m a k e r s p i k e s i s d e g ra d e d . I f

pa c e m a k e r de t e c t i on i s e na bl e d , t he ES U i nt e rf e re nc e

m a y b e d e t e c t e d a s pa c e m a k e r s p i k e .

Dräger recommends the use of the MultiMed Plus OR

d ur i n g e l e c t r o s u r g e r y o n l y.

Do not use the MultiMed Plus OR cable with Dräger blue

ECG lead wires. Doing so, will degrade performance

w hi c h c a n r e s u l t i n i n a c c u r a t e v a l u e s .

NOTE:

Use SpO2 instead of the ECG parameter to determine heart rate.

Use rectal temperature probe sheaths to cover internally placed temperature

sensors.

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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 etCO2 monitors and pods (except for the Infinity etCO2

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.

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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

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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

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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

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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

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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

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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

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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

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1 INTRODUCTION

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

calculations)

3-lead ST segment analysis

Waveform channel upgrades (Kappa only: 4 channels to 5 channels. Delta/

Kappa only: 5 channels to 6 channels. Delta/Delta XL/Kappa: 6 channels to 8

channels)

Aries (Advanced Review of Ischemia Event System)

One PodCom connection is standard on the Delta monitor, a second PodCom

connection is optional. Two PodCom connections are standard on the Kappa

Delta XL. Three PodCom connections are available on Kappa.

MIB (Kappa only: Advance Communication. Delta/Delta XL only: MIB II 1

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.

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OVERVIEW

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

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Display unit

2

Kappa base unit

1-3