Embla Sandman Manuel utilisateur

embla

Sandman Digital 32+ Amplifier

® ™

User Manual

Sandman Digital 32+ Amplifier User Manual

Applies to the Sandman Digital 32+ Amplifier, Sandman elink Adapter, and Sandman DC Expansion (DCX) Box

Issued May 2012. Printed in the USA or The Netherlands.

Document Number: D-1002-001, Revision 3.0

Document Item Number: 4280034

For assistance, please contact Embla Technical Support ([email protected]).

MANUFACTURER EUROPEAN REPRESENTATIVE

Embla Systems

1 Hines Rd, Suite 202

Kanata, ON K2K 3C7

Canada

Tel: +1.613.254.8877

Fax: +1.613.270.0627

Natus Europe GmbH

Robert-Koch-Str. 1

82152 Planegg

Germany

Tel: +49 089 83942-0

Fax: +49 089 83942-777

TOLL-FREE IN NORTH AMERICA: 888 NO APNEA (888.662.7632)

www.embla.com [email protected] [email protected]

Disclaimer

This document may contain technical inaccuracies or typographical errors. Embla does not accept any liability for

the use or misuse, direct or indirect, of this product. Users must accept all responsibility for any results obtained by

or concluded from the products. All clinical conclusions and decisions that are made based on the use of this

product are the responsibility of the user. Embla does not accept any liability or responsibility for damages

arising out of the use of or inability to use this product.

Information in this document, including URL and other Internet website references, is subject to change without

notice. Complying with all applicable copyright laws is the responsibility of the user. Without limiting the rights

under copyright, no part of this document may be altered for any purpose, without the express written permission

of Embla. The subject matter in this document is the express property of Embla. Unless specifically provided in any

written license agreement from Embla, the furnishing of this document does not give you any license to these

trademarks, copyrights, or other intellectual property.

Trademarks

Embla, Sandman, and Sandman Elite are registered trademarks of Embla Systems. Sandman Digital 32+ and

Sandman elink are trademarks of Embla Systems. All other trademarks are the property of their respective

owners.

0051

The Sandman Digital 32+ Amplifier is certified to carry the CE mark. The CE mark is a declaration

that the Sandman Digital 32+ Amplifier is in compliance with the directive for medical devices set

forth by the European Union.

The cCSAus mark is a safety symbol that shows the product has been independently tested and

certified to applicable U.S. and Canadian product safety standards.

MANUFACTURED IN ITALY BY:

EBNeuro S.p.A.

via Pietro Fanfani 97/A

50127 Firenze

ITALY

Distributed by Embla Systems.

Table of Contents

1. General Warnings and Cautions ......................................................................................................... 1

1.1. intended use .......................................................................................................................................... 1

1.2. safety information and document conventions................................................................................ 1

1.3. warnings ................................................................................................................................................ 1

1.4. amplifier casing symbols ..................................................................................................................... 2

1.5. electromagnetic compatibility............................................................................................................. 3

1.5.1. recommended distance from Radio Frequency systems....................................................4

2. Safety .................................................................................................................................................. 6

2.1. operational environment ..................................................................................................................... 6

2.1.1. electrical safety.........................................................................................................................7

2.1.2. patient leakage current............................................................................................................8

2.1.3. patient connection....................................................................................................................8

2.2. LCD display........................................................................................................................................... 8

2.3. declaration of conformity .................................................................................................................... 9

2.4. caution for the U.S. market.................................................................................................................. 9

3. Introduction ...................................................................................................................................... 10

3.1. Sandman Digital 32+™ amplifier (SD32+)...................................................................................... 10

3.2. headbox................................................................................................................................................ 11

connectors.........................................................................................................................................11

electrode sockets ..............................................................................................................................12

3.3. amplifier............................................................................................................................................... 15

ports...................................................................................................................................................16

sockets ...............................................................................................................................................16

3.4. LCD display......................................................................................................................................... 17

3.5. integrated pulse oximeter.................................................................................................................. 18

3.6. Sandman elink™ adapter .................................................................................................................... 19

3.7. power supply ...................................................................................................................................... 20

3.7.1. external medical grade ac/dc adapter ................................................................................20

3.7.2. amplifier power modes.........................................................................................................21

3.7.3. surge protection .....................................................................................................................21

3.8. DC expansion box............................................................................................................................... 21

inputs.................................................................................................................................................22

4. Software Driver Installation .............................................................................................................23

5. Amplifier System Assembly..............................................................................................................24

5.1. connecting the headbox to the amplifier ......................................................................................... 24

5.2. connecting the amplifier to the sandman elink adapter .................................................................. 24

5.3. connecting the external power supply to the amplifier system ................................................... 24

5.4. connecting the DC expansion box to the computer (serial connection)...................................... 25

5.5. connecting the DC expansion box to the computer (USB connection)........................................ 25

6. Calibration.........................................................................................................................................27

6.1. system record calibration .................................................................................................................. 27

7. Maintenance .....................................................................................................................................28

7.1. safety checks........................................................................................................................................ 28

7.2. operational environment electrical equipment .............................................................................. 28

7.3. amplifier calibration........................................................................................................................... 28

7.4. cables and connectors......................................................................................................................... 28

7.5. cleaning ................................................................................................................................................ 29

8. Specifications ....................................................................................................................................30

8.1. system specifications.......................................................................................................................... 30

8.2. environmental operating conditions................................................................................................ 31

8.3. environmental conditions for storage.............................................................................................. 31

8.4. amplifier specifications...................................................................................................................... 31

8.4.1. general amplifier specifications ...........................................................................................31

8.4.2. filters........................................................................................................................................32

8.4.3. resolution, full scale range, noise.........................................................................................32

8.4.4. sampling rate..........................................................................................................................33

8.5. headbox specifications ....................................................................................................................... 33

8.6. external medical grade AC/DC adapter specifications ................................................................ 34

8.6.1AULT SW173........................................................................................................................34

8.6.2SINPRO MPU50-106 ...........................................................................................................34

8.7. Sandman elink™ adapter................................................................................................................... 35

8.8. DC expansion box specifications...................................................................................................... 35

8.8.1. technical characteristics.........................................................................................................35

8.8.2. environmental conditions.....................................................................................................36

8.9. pulse oximeter performance ............................................................................................................. 36

List of Figures

Figure 1. the SD32+ system...................................................................................................................... 11

Figure 2. the headbox amplifier connection port .................................................................................. 12

Figure 3. removable patient box (headbox) link port ........................................................................... 12

Figure 4. headbox to amplifier cable....................................................................................................... 12

Figure 5. headbox electrode sockets........................................................................................................ 13

Figure 6. SD32+ amplifier’s external connections (front)..................................................................... 15

Figure 7. SD32+ amplifier’s external connections (back) ..................................................................... 15

Figure 8. Sandman elink adapter............................................................................................................... 19

Figure 9. fiber optic cable.......................................................................................................................... 20

Figure 10. external medical grade ac/dc adapter ................................................................................. 20

Figure 11. power transfer cable ............................................................................................................... 21

Figure 12. dc expansion box input sockets............................................................................................. 22

Figure 13. SD32+ amplifier dc expansion box cable ............................................................................. 25

Figure 14. typical SD32+ system set-up.................................................................................................. 26

List of Tables

Table 1. electromagnetic emission............................................................................................................. 3

Table 2. electromagnetic immunity........................................................................................................... 4

Table 3. recommended distances............................................................................................................... 5

Table 4. SD32+ amplifier headbox sockets............................................................................................. 14

SD32+

System General Warnings and Cautions

1. General Warnings and Cautions

This document contains proprietary information. No part of this publication may be reproduced

in any form without written permission from Embla Systems.

1.1. intended use

The Sandman®Digital 32+™ Amplifier ("SD32+") is intended to be used by or under the direction

of a physician for acquisition of EEG, polygraphy, and polysomnography signals and

transmission of these signals to a PC during recording of neurophysiology examinations.

1.2. safety information and document conventions

The following table describes the safety and document conventions found in this manual:

Warning The Warning message appears in this manual before procedures or tasks

that must be strictly observed to avoid patient harm, inaccurate

measurements, or loss of data.

Caution The Caution message appears in the manual before procedures or tasks that

must be strictly observed to avoid damage to the product.

Note The Notes message contains important information to help the operator

complete a procedure or task correctly.

1.3. warnings

1. Do not disassemble the SD32+ or Headbox.

2. All connections on the Headbox are isolated from the ground of your building’s

electrical system (AC power ground). This type of insulation is known as “floating

isolation”. To avoid injury to the patient, do not connect input signals to the

Headbox from devices that are not equipped with floating isolation.

3. To maintain the SD32+ electrical isolation ensure that neither the patient nor any

conductive part connected to the patient (such as electrodes or sensors) comes into

contact with any conductive material.

4. Verify that the building’s electrical wiring is in good condition and properly

grounded. To ensure the safety of both patient and technician make certain that any

AC powered device connected to the SD32+ is properly grounded.

5. Always follow the safety precautions outlined in chapter 2. Safety on page 6of this

manual.

6. Place the computer outside of the patient area. If this is not possible, power the

computer through a dedicated isolation transformer.

7. Carefully route and secure sensor cables to avoid patient entanglement or

strangulation.

General Warnings and Cautions

SD32+

System

1.4. amplifier casing symbols

This symbol identifies ports or sockets equipped with a Type BF level of electrical

isolation in accordance with IEC60601-1.

This symbol prompts the user to refer to this manual for proper usage and safety

instructions.

This symbol identifies input connectors.

This symbol identifies output connectors.

This symbol identifies the manufacturing date

REF This symbol identifies the part number of the device

SN This symbol identifies the serial number of the device

SD32+

System General Warnings and Cautions

1.5. electromagnetic compatibility

This device is designed for use in environments that comply with IEC 60601-1-2:2001 as indicated

in the tables shown. You must ensure that the device is used in compliance with the IEC

standards.

Emission Test Compliance Electromagnetic Environment

Radiated and Conducted RF

emission

CISPR 11

Class B The device is suitable for use in domestic and

other environments that are connected to a low

voltage power supply.

Group 1 The internal operation uses a low RF. The

emission is not likely to cause interference with

nearby electronic equipment.

Harmonic emission

IEC 61000-3-2

Complies The device may be connected directly to a low

voltage supply using an electrical ground.

Voltage fluctuations/flicker

emissions

IEC 61000-3-3

Complies The device may be connected directly to a low

voltage supply using an electrical ground.

Table 1. electromagnetic emission

Immunity Test IEC 60601-1-2 Test Level Compliance Electromagnetic

environment

Electrostatic

Discharge

(ESD)

IEC 61000-4-2

6 kV direct contact

8 kV through air IEC 60601-1-2 Test

Levels Residential

(Note 1)

Electrical fast

transient/burst

IEC 61000-4-4

2 kV for power supply line

1 kV for input/output line

>3m

IEC 60601-1-2 Test

Levels Residential

(Note 2)

(Note 3)

Surge

IEC 61000-4-5 1 kV differential mode

2 kV common mode IEC 60601-1-2 Test

Levels Residential

(Note 2)

(Note 3)

Voltage dips,

short

interruptions

and voltage

variation on

power supply

input lines

IEC 61000-4-11

0% of rated voltage (voltage

dip 100%) for 0.5 cycles

40% of rated voltage

(voltage dip 60%) for 5

cycles

70% of rated voltage

(voltage dip 30%) for 25

cycles

0% of rated voltage (voltage

dip 100%) for 5 cycles

Residential

(Note 2)

(Note 3)

General Warnings and Cautions

SD32+

System

Immunity Test IEC 60601-1-2 Test Level Compliance Electromagnetic

environment

Magnetic fields

at ground

frequency

(50/60Hz)

IEC 61000-4-8

3 A/m

Radiated RF

fields

IEC 61000-4-3

Non-life-supporting

equipment

3 V/m

From 80 MHz to 2.5 GHz

IEC 60601-1-2 Test

Levels Residential

(Note 4)

Conducted RF

fields

IEC 61000-4-6

Non-life-supporting

equipment

3 V

From 150 kHz to 80 MHz

Measures to observe

Note 1 – The floor should be antistatic (wood, ceramic, etc.). If carpeted, the relative humidity

should be maintained at 30%.

Note 2 – The main power supply must be of residential, commercial, or medical grade.

Note 3 – If operating for an extended period, a UPS system must be provided in the event of a

power outage.

Note 4 – Mobile or portable RF communication devices should be used at greater distances than

those provided in table 3.

Table 2. electromagnetic immunity

1.5.1. recommended distance from Radio Frequency systems

It is not recommended to use RF transmitting devices near the SD32+ digital amplifier. RF

transmitting devices can cause interference with the device and impact the quality of the signals

being acquired during use.

To prevent RF interference it is recommended to maintain a minimum distance between the

SD32+ digital amplifier and the RF transmitting device being used; such as cell/mobile phones.

The following table shows recommended distances that the SD32+ digital amplifier should

remain from some common RF transmitting devices.

RF Source Typical Rated

Power (W) Distance

(m)

Microcellular phone CT1, CT2, CT3 0.01 0.3

DECT cellular phone, Wireless Information

Technology equipment (modems, LAN's) 0.25 2

Cellular phone, hand-held (USA) 0.6 2

Cellular phone, hand-held (GSM and NMT,

Europe DECS 1800) 2

8 4

Walkie-talkie (Rescue, police, fire, maintenance) 5 3

Cellular phone, bag 16 10

Mobile radio (Rescue, police, fire) 100 30

SD32+

System General Warnings and Cautions

For transmitters, the maximum output power of which is not within the values above, the

recommended distance can be estimated by using the following calculations:

For transmitters using a frequency range from 150 kHz to 80 MHz and 80MHz to 800 MHz, the

distance can be estimated as follows: D = 1.2√P

For transmitters using a frequency range from 800 MHz to 2.5 GHz, the distance can be

estimated as follows: D = 2.3√P

P = the rated power of the transmitter in Watts (W).

Note: Always use the greater distance provided.

Note: These values are general guidelines as electromagnetic fields can be compromised in

the presence of structures, objects, and people.

Table 3. recommended distances

Always remember that the intensity of the electromagnetic field generated by a fixed transmitter

(base station for radio, TV, Cell service, etc.) cannot be predicted.

Additional measures may be required if the electromagnetic field exceeds the specified intensity

shown in table 3.

Safety

SD32+

System

2. Safety

Please follow all warnings and cautions listed in this manual to ensure the safety of the patient

and the operator.

Warning: Before using the SD32+ system, ensure that it satisfies all safety requirements.

Safety checks should be performed periodically and no less than twice a year.

2.1. operational environment

The SD32+ amplifier is designed to work in the following environmental conditions:

temperature 5°C to 40°C

relative humidity 30% to 75% RH

atmospheric pressure 700 to 1060 hPa

Avoid condensation.

Use caution when operating the amplifier after moving it between locations with different

temperatures. Condensation (slight moisture accumulation or misting over internal or external

surfaces of the amplifier) may occur if the amplifier is moved rapidly from a cold location to a

warmer location. Wait for the condensation to evaporate completely before supplying power to

and using the amplifier.

Avoid flammable vapors or gases.

Do not use the amplifier in atmospheres with high oxygen concentration or in buildings where

flammable substances or anesthetic agents are present.

Avoid contact with liquids.

The amplifier and its internal parts are not protected against the inflow of liquids. Avoid

exposing the amplifier to moisture or using the amplifier where such a risk is present.

Components that have been penetrated by liquids must be cleaned immediately and checked by

authorized personnel.

Ensure proper electrical grounding.

The building’s electrical wiring must be properly grounded. When the amplifier is connected to

other AC powered devices ensure those devices are grounded. This protection is essential for the

safety of both the patient and the technician.

Avoid strong magnetic fields.

Keep the amplifier away from sources of induced electromagnetic fields to avoid possible

instability or malfunction. The SD32+ system is compliant with the EMC (Electromagnetic

Compatibility) requirements specified by the 89/336/EEC European directive.

Avoid short wave or microwave devices.

Therapeutic short wave or microwave devices may cause instability and interfere with the

amplifier’s functions. Do not place the amplifier near X-ray or diathermy devices.

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