Infinity Delta Series Patient Monitoring Series SW VF9 Ed 5 Instructions for Use Jan 2019

Infinity Delta Series Instructions for Use Software VF9 ©Drägerwerk AG & Co. KGaA 2016. All rights reserved. Printed in the United States of America. Reproduction in any manner, in whole or in part, in English or in any other languages, except for brief excerpts in reviews and scientific papers, is prohibited without prior written permission of Dräger. Before using any Dräger devices, carefully read all the manuals that are provided with your device. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

ACE®, DrägerService®, MultiMed®, Hemo2®, Hemo4®, Infinity®, SmartPod®, Trident®, Pick and Go®, Scio®, MicrO2+®, and OxiSure® are trademarks of Dräger. PiCCO®, PULSION®, and PULSIOCATH® are trademarks of PULSION Medical Systems. CAPNOSTAT® is a trademark of Coviden

BIS® and Bispectral Index® are trademarks of Coviden.

CNAP® is a trademark of CNSystems Medizintechnik. A-2000 and BISx are trademarks of Aspect Medical Systems, Inc. Masimo®, Masimo SET® and Signal Extraction Technology (SET)® are trademarks of Masimo Corporation. Nellcor® is a trademark of Covidien

SILICON SOFTWARE © 1989, 90, 91, 92, 93, 94 Microtec Research Inc. All rights reserved Some graphics courtesy of Coviden Unpublished rights reserved under the copyright laws of the United States. RESTRICTED RIGHTS LEGEND Use duplication or disclosure by the Government is subject to restrictions as set forth in subparagraph (c)(1)(ii) of the Rights in Technical Data & Computer Software clause at DFARS 252 227:7013 The capnography component of this product is covered by one of the following US patents: 6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending. Microstream® is a trademark of Oridion Medical 1987 Ltd. All other brand or product names are trademarks of their respective owners.

2

Instructions for Use Delta/Delta XL/Kappa VF9

Overview Intended Use ...10 Indications for Use ...10 Intended Patient Categories ...11 Functional Safety...11 Documentation Features...12 Warnings, Cautions, Notes ...12 Cross-references...12 Quick Reference Tables ...12 Footer ...12 Applicability ...13 Definition of Target Groups ...13 Users ...13 Service Personnel ...13 Experts ...13 Safety Considerations...14 Site of Operation ...15 Maintenance ...16 General Electrical Safety ...20 Potential Equalization Terminal ...22 Defibrillator Precautions ...22 Pacemakers ...23 Peripheral Devices ...23 Electrosurgery ...23 Medical Device Disposal ...25 Disposal of Accessories...25 Electromagnetic Compatibility ...25 Table of Contents ...27

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. NOTE: The Infinity CNAP SmartPod is available in selected markets. Contact your local sales representative for details and availability.

Indications for Use The Infinity Delta series monitors are capable of monitoring:

4



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

DELTA/DELTA XL/KAPPA

VF9

INFINITY DELTA SERIES USER ’S GUIDE 

Neuromuscular transmission

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.

Functional Safety The essential performance of a patient monitor is to provide a clinician with meaningful parameter values and alarm annunciation when the established parameter limits have been exceeded or the ability to provide values is compromised. Risks associated with use of the monitor in light of these essential performance functions have been evaluated and mitigations implemented so that the residual risk is as low as reasonably practicable, provided routine maintenance and service recommendations are followed throughout the life of the product.

VF9

DELTA/DELTA XL/KAPPA

5

INFINITY DELTA SERIES USER ’S GUIDE

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 i n f o r m a t i o n a b o u t a p o t e n t i a l l y h a z a r d o u s s i t ua t i o n w hi c h , i f n ot a v oi d e d, c ou l d re s ul t in de a t h o r s e ri o us i nj ur 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.

Footer The current software version appears at the bottom of each page, together with the chapter and page number and the device name.

6

DELTA/DELTA XL/KAPPA

VF9

INFINITY DELTA SERIES USER ’S GUIDE 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, 2-18, and 3-21). Internal battery (see pages A-3, and B-10). Size and weight (see page B-9).

Definition of Target Groups For this product, users, service personnel, and experts are defined as target groups. These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.

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

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

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

VF9

DELTA/DELTA XL/KAPPA

7

INFINITY DELTA SERIES USER ’S GUIDE

Safety Considerations These Instructions for Use assume 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. . 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 ti o n s f o r U s e and on equipment labels. WA R N I N G : N o m o d i f i c a t i o n o f t hi s e q u i p m e n t is a l l o w e d . Risk- modification of this equipment may cause interference w i t h o t h e r d e v i c e s , i n j u r y t o pa t i e n t a n d u s e r i n c l u d i n g e le c t r i c s h o c k , b u r n s o r d e a t h . WA R N I N G : R i s k o f n o t h e a r i n g a la r m s . A r a p i d r e c o g n i t i o n o f a la rm s a n d a n a p p r o p r i a t e r e s p o ns e a r e o n l y p o s s i b l e i f t h e user is within the hearing range of the acoustic alarm s ig na l s . T h e u s e r m u s t s ta y w i t h i n t h e h e a r i n g r a n g e o f t h e a c o u s t i c a l a r m s i g na l s a n d a d j u s t t he v ol u m e a c c o r d i n g t o t h e d is ta nc e f r o m t h e m e d i c a l d e v i c e .

8

DELTA/DELTA XL/KAPPA

VF9

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. 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 n v i r o n m e n ts , a i r c r a ft , a mb ul a n c e , h om e o r h y pe rb a ri c c ha mb e r s .

VF9



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 od s , m o d ul 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 q u i p m e n t t h a t e m i ts m i c r o w a v e o r o t h e r h i g h- f r e q ue n c y e m i s s i o n s s i n c e 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 os 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 t h e “ A p p r o v e d O p t i o n s a n d A c c e s s o r i e s ” c h a pt e r h a v e 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 . A c c o r d i n g l y i t i s s t r o n g l y r e c o m m e n d e d t h a t o nl y t h e s e a c c e s s o r i e s b e u s e d i n c o n j u nc t i o n w i t h t h e s p e c i f i c d e v i c e . O t h e r w i s e t h e c o r r e c t f u n c t i o n i n g o f t he d e v i c e may be compromised.



Disposable accessories (such as disposable e l e c t r o d e s , t r a n s d u 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. D o n o t r e u s e d i s p o s a bl e a c c e s s o r i e s .



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 u l l y p os i t i o n a nd s e c u r e s e n s o r c a b l e s . A l s o c a r e f u l l y p os 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 uc t i v e l o o ps .



This medical device is neither approved nor certified f o r u s e i n a r e a s w he r e o x y g e n c o n c e n t ra t i o n s g r e a t e r than 25 %, combustible or where explosive gas m i x t u re s a r e l i k e l y t o o c c u r.



Because of the danger of electric shock, never remove 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.



To a v o i d pa t i e n t i n j u r y a s t he r e s u l t o f a f a l l i n g m o n i t o r w h e n u s i n g a r o l l i n g s ta n d , u n i v e r s a l b e d h o o k o r h a n d l e h oo k m o u nt , d o n o t a p p l y e x c e s s i v e f o r c e t o t h e m o n i t o r o r m o u n t t o e n t e r / e x i t e l e v a t o rs , o r t o pa s s over thresholds etc.

DELTA/DELTA XL/KAPPA

9

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.

Maintenance Overview This chapter describes the maintenance measures required to maintain the proper functioning of the medical device. Maintenance measures must be performed by the responsible personnel. WA R N I N G :  Risk of infection. Users and service personnel can b e c o m e i n f e c t e d w i t h pa t h o ge n i c g e r m s . D i s i n f e c t a n d c l e a n t h e d e v i c e o r t h e d e v i c e pa r ts b e f o r e a ny maintenance measures and also before returning the m e d i c a l d e v i c e f o r r e pa i r.

10



R i s k o f e l e c t r i c s h o c k . C u r r e n t - c a r r y i n g c o m p o n e n ts a re l o c a t e d u n d e r t h e c o v e r. D o n o t r e m o v e t h e c o v e r. M a i n t e n a n c e m e a s u r e s m u s t b e p e r f o rm e d b y t h e responsible personnel. Dräger recommends D r ä g e rS e r v i c e t o p e r f o rm t h e s e m e a s u r e s .



If the device is mechanically damaged, or if it is not w or k i n g p r o pe rl y, d o n o t u s e i t . C o n ta c t y o u r h o s p i ta l ’s technical personnel. Never perform monitor service or m a i n t e n a n c e a c t i v i t i e s w hi l e a c t i v e l y m o n i t o r i n g a pa t i e n t .



To a v o i d e l e c t r i c s h o c k d i s c o n n e c t A C l i n e c o r d f r o m power supply prior to servicing the device.

DELTA/DELTA XL/KAPPA

VF9

INFINITY DELTA SERIES USER ’S GUIDE

CAUTION: 

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



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

Definition of Maintenance Concepts Concept

Definition

Maintenance

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

Inspection

Measures intended to determine and assess the actual state of a medical device.

Preventative Maintenance

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

Repair

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

Inspection Perform inspections at regular intervals and observe the following specifications. Delta/DeltaXL/Kappa Checks

Interval

Personnel Responsible

Inspection/safety checks

Every 2 years

Service personnel

Metrological checks

Every 2 years

Service personnel

VF9

DELTA/DELTA XL/KAPPA

11

INFINITY DELTA SERIES USER ’S GUIDE Safety checks for Delta/DeltaXL/Kappa Safety checks are no substitute for preventive maintenance measures (including preventive replacement of wear parts) as identified by the manufacturer. Perform safety checks at the indicated intervals. WA R N I N G : R i s k o f m e d i c a l d e v i c e f a i l u r e . I f s a f e t y c h e c k s a r e n ot p e rf orm e d on a re gu l a r b a s i s , t he p ro pe r op e ra t i on of t h e medical device can be compromised.

Perform safety checks at the indicated intervals. • Check accompanying documents:

The instructions for use are available, according to the user/owner

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

• Power On/Off LED’s and tone • Battery charging indicator LED • Visual and acoustic alarm signals • Touch Keys on front panel • ECG lead off • Non-invasive blood pressure • Check/visual inspection of internal battery

• Check that the device combination is in good condition:

• Labels and inscriptions are complete and legible. • There is no visible damage

• Use the instructions for use to check that all components and accessories needed to use the product are available • Check the electrical safety requirements according to IEC62353

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

12



Body temperature



Non-invasive blood pressure

DELTA/DELTA XL/KAPPA

VF9

INFINITY DELTA SERIES USER ’S GUIDE Preventive Maintenance WA R N I N G :  R i s k o f f a u l t y c o m p o n e n ts D e v i c e f a i l u r e i s p o s s i b l e d u e t o w e a r o r m a t e r i a l f a t i g u e o f t h e c o m p o n e n ts . To m a i n ta in p r o p e r o p e r a t io n o f a l l c o m p o n e n ts , t h i s d e v i c e m u s t u nd e r g o i n s p e c t i o n a n d p re v e n t i v e maintenance at specified intervals. 

Risk of electric shock. Before performing any maintenance work, disconnect all electrical connectors f r o m t h e p o w e r s u p p l y.

The following table shows the preventive maintenance intervals: Component

Interval

Personnel Responsible

NBP filter

Replace every 2 years Service personnel

Repair Dräger recommends that all repairs are carried out by Dräger Service and that only authentic parts are used. The monitor’s Service Manual is available from your local Dräger Medical service representative.

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 s e r v i c e p e r s o n n e l o t h e r w i s e t h e c o r r e c t f u n c t i o ni n g o f 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 r e g u l a t i o ns ) . C o n n e c t i n g t hi s m e d i c a l d e v i c e t o o t h e r m e d i c a l d e v i c e s c o u l d r e s u l t i n a d d i t i o n a l m a i n t e n an c e 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 na l r e q ui r e m e n ts .

VF9



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 n l y a u t h e n t i c D r ä g e r r e pa i r pa r ts d u r 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 dv 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 ot 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 . A l w a y s o bs e r v e i n s ta l l a t i o n i n s t r u c t i o n s w i t h t h e mount.

DELTA/DELTA XL/KAPPA

13

INFINITY DELTA SERIES USER ’S GUIDE 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. Devices should be used in accordance with Dräger Instructions for Use.

General Electrical Safety This device can be operated in combination with other Dräger devices or devices from other manufacturers. WA R N I N G : O b s e r v e t h e a c c o m pa n y i n g d o c u m e n ta t i o n o f t h e s pe c i f i c d e v i c e s . I f a d e v i c e c o m b i n a t i o n i s n ot a pp ro v e d b y D r ä g e r, t h e s a f e t y a n d f u n c t i o n a l i t y o f t h e i n d i v i d u a l d e v i c e s can be compromised.

The operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices. Device combinations approved by Dräger meet the requirements of the following standards: 

IEC 60601-1, 3rd edition (general safety requirements, device combinations, software controlled functions)



IEC 60601-1-2 (electromagnetic compatibility)



IEC 60601-1-8 (alarm systems)



IEC 60601-1, 2nd edition (general safety requirements)



IEC 60601-1-1 (device combinations)



IEC 60601-1-2 (electromagnetic compatibility)



IEC 60601-1-4 (software-controlled functions)



IEC 60601-1-8 (alarm systems)

Or:

14

DELTA/DELTA XL/KAPPA

VF9

INFINITY DELTA SERIES USER ’S GUIDE 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: 

When connecting the Dräger monitor to other equipment not described in these instructions for use e ns u r e c o m p l i a n c e o f t h e c o n f i g u r e d m e d i c a l e l e c t r i c a l s y s t e m w i t h t h e r e q u i r e m e n ts o f I E C 6 0 6 0 1 - 1 / I E C 60601-1-1.



To a v o i d e le 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 l e s t h a t a p p e a r c ra c k e d , w o r 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 ie 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 un de d , c o n n n e c t t h e A C a da p t e r, c o m m u ni c a t i o n p ow e r s u p pl 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.

WA R N I N G : T h e u s e o f m u l t i p l e s o c k e t - o u t l e ts s h o u ld b e avoided as far as possible. The combined earth leakage c u r r e n ts c o u l d r e s u l t i n :  Excessive earth leakage current in normal condition 

E x c e s s i v e t o u c h c u r r e nt i n t h e s i n g l e f a u l t c o n d i t i o n o f t h e b ro k e n p ro t e c t i v e e a r t h c o n d u c t o r o f t h e m u l t i p l e s oc k e t - o u t l e t s u p pl y c a b l e



Av a i l a b i l i t y o f t h e s u p p l y m a i n s d e p e n d s o n t h e reliability of a single fixed mains socket outlet



A complete interruption of electrical supply is possible a n d m i g ht r e q u i r e a l o n g s e t - u p t i m e t o r e a c t i v a t e t h e complete ME system



O nl y o ne p ro t e c t i v e e a r t h c o n ne c t i o n t o t he e l e c t r i c a l i n s ta l l a t i o n i s p r o v i d e d ; t h i s i s l e s s r e l i a b l e t h a n w h e n e a c h pa r t o f t h e M E s y s t e m i s d i r e c t l y e a r t h e d



T he p ro t e c t i v e e a r t h r e s i s ta n c e i s i n c re a s e d .

T he o pe ra t i n g o rg a n i z a t i o n m u s t e ns u r e t ha t t he d e v i c e c om b i n a t i o n c o m p l i e s w i t h t h e a p p l i c a b l e e d i t i o n s o f t h e r e l e v a n t s ta n d a r d s f o r m e d i c a l d e v i c e s .

VF9

DELTA/DELTA XL/KAPPA

15

INFINITY DELTA SERIES USER ’S GUIDE 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.

Potential Equalization Terminal Even small electrical potential differences between housing surfaces of different devices in the vicinity of the patient can be reduced by potential equalization (consider IEC 60601-1 for Medical Electrical Systems). 1. Connect one end of the potential equalization cable to a potential equalization pin. 2. Connect the other end of the potential equalization cable to the potential equalization connector on the operating table or the wall. NOTE:

Do not use the connection as a PE (protective earth) connection.

Defibrillator Precautions Defibrillator Precautions: The monitor is protected against defibrillator voltages, highfrequency interference from electrosurgical units and 50 / 60 Hz interference. Following defibrillation, the monitor begins displaying waveform data again within 5 seconds if the correct electrodes are used and those electrodes are applied in accordance with the manufacturer's instructions.

WA R N I N G : To p r o t e c t t h e pa t i e n t d u r i n g d e f i b r i l l a t i o n a n d t o ensure accurate ECG information use only ECG electrodes a n d c a b l e s s p e c i f i e d b y D r ä g e r. R e m o v a l o f a p p l i e d pa r ts t h a t a r e n o t r a t e d d e f i b r i l l a t i o n p r o o f s u c h a s d i s p o s a b l e SpO 2 s e n s o r s m a y b e r e q ui r e d t o p re v e n t s e n s o r b r e a k d o w n a n d e ne r gy s hu nt i n g.

CAUTION:

16



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.

DELTA/DELTA XL/KAPPA

VF9

INFINITY DELTA SERIES USER ’S GUIDE 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 29-5 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 n o t 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 U s e s ho u l d o n l y b e m a d e f o l l o w i n g c o n s u l ta t i o n w i t h t h e r e s pe c t i v e m a n uf a c t u r e r.

Electrosurgery To support user and patient safety and to reduce electro-surgical unit (ESU) interference, observe the following precautions during electrosugery.

VF9

DELTA/DELTA XL/KAPPA

17

INFINITY DELTA SERIES USER ’S GUIDE

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 burns, do not use these pods in an ESU environment. 

F or be t t e r p e r f or ma nc e a nd t o r e d uc e t he h a z a r d o f b ur n s d u r i n g s ur 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 e n 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 n d 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 s ur g i c a l s i t e , t h e e l e c t r o - s u r g i c a l u ni t r e t u r n e l e c t r o d e , 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 lead wires. For better performance, also set the ECG filter 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 ul t i M e d P l u s O R , u s e o nl y D r ä g e r b l u e E C G l e a d s e ts . T he 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 u r 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 which can result in inaccurate values.

NOTE:

18



If ESU issues arise with HR values from ECG source, change the source to ART or SpO2



Use rectal temperature probe sheaths to cover internally placed temperature sensors.

DELTA/DELTA XL/KAPPA

VF9

INFINITY DELTA SERIES USER ’S GUIDE Medical Device Disposal WA R N I N G : R i s k o f i n f e c t i o n . T he d e v i c e a n d i ts c o m p o n e n ts must be disinfected and cleaned before disposal.

When disposing of the medical device: 

Consult the relevant waste disposal company for appropriate disposal.



Observe the applicable laws and regulations.

For countries subject to the EU Directive 2002/96/EC This device is subject to EU Directive 2002/96/EC (WEEE). In order to comply with its registration according to the directive, this device may not be disposed of at municipal collection points for waste electrical and electronic equipment. Dräger has authorized a company to collect and dispose of this device. To initiate collection, or for further information, visit Dräger on the internet at www.draeger.com. Us the Search function with the keyword “WEEE” to find the relevant information. If access to Dräger’s website is not possible, contact the local Dräger organization.

Disposal of Accessories When disposing of accessory parts, observe the hospital hygiene regulations and the respective instructions for use.

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:

VF9



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.

DELTA/DELTA XL/KAPPA

19

INFINITY DELTA SERIES USER ’S GUIDE

20



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 and secure properly at both ends.



Ensure electrical maintenance is done by qualified personnel.



For more information on Electromagnetic Compatibility, see page B-3.

DELTA/DELTA XL/KAPPA

VF9