Siesta 802a and Safiro User Guide Issue 1 April 2013

Siesta 802a and Safiro User Guide AF768-01 Part Number: 0207-0030-01 © Compumedics Limited Issue 1

April 2013

This work is copyright. Apart from any use as permitted under the Copyright Act 1968 no part may be reproduced by any process without written permission from Compumedics Limited. Requests and inquires concerning reproduction and rights should be addressed to: The Documentation Manager Compumedics Limited 30 – 40 Flockhart Street Abbotsford, Victoria, 3067 AUSTRALIA

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Table Of Contents TABLE OF CONTENTS...I 1

BEFORE YOU BEGIN...1 1.1 Limited Warranty – Hardware...1 1.2 Limited Warranty – Electrodes, Sensors And Leads...2 1.3 Safety And Effectiveness Considerations...2 1.4 Transport And Storage Conditions...2 1.5 Indications For Use...2 1.6 Contraindications...3 1.7 Labelling Definitions...3 1.8 Warnings And Cautions...4 1.9 Prescription Device...6 1.10 Placement of Equipment...6 1.11 Interference...6 1.12 Manufacturer's Recommendations...6 1.13 Cleaning...7 1.14 Wiring...7 1.15 Care... 7 1.16 Product Support...8

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INTRODUCING SIESTA 802A AND SAFIRO...11 2.1 System Components...11 2.1.1 Recording Unit...11 2.1.2 Batteries...13 2.1.3 Power Supply / Battery Charger...14 2.1.4 Host PC...16 2.2 Communication Modes...16 2.2.1 Wireless LAN...16 2.2.2 Compact Flash Card...17 2.2.3 Infra-Red Port...17 2.3 Study Types...18 2.3.1 PSG...18 2.3.2 EEG...18 2.4 Software...19 2.4.1 Data Card Manager...19 2.4.2 NetBeacon...20 2.4.3 PSG Online...21 2.4.4 Profusion PSG...22

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Table Of Contents 2.4.5

Profusion EEG...23

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SETTING UP SIESTA...25 3.1 Computer System Requirements...25 3.1.1 PC Configuration...25 3.1.2 Operating System And Additional Software...26 3.1.3 Software Protection Key...26 3.2 Installing Compumedics Software...27 3.2.1 Updating Compumedics Software...28 3.3 Configuring the Siesta Wireless LAN...29 3.3.1 Format Of The WIFI.CFG File...30 3.3.2 Selecting The Siesta IP Address...35 3.3.3 Infra-Structure Or Adhoc Mode?...36 3.3.4 Siesta 802 Configuration Tool...38 3.4 Additional Siesta Device Configuration...39 3.4.1 Optional Operating Modes...39 3.4.2 Device Calibration (PSG Studies Only)...40 3.4.3 Compact Flash Card...41 3.5 Pouch For Ambulatory Studies...42 3.6 Configuring Compumedics Software...44 3.6.1 Data Card Manager...44 3.6.2 NetBeacon...44 3.6.3 PSG Online...45 3.6.4 Profusion EEG...47

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USING SIESTA FOR SLEEP STUDIES...49 4.1 Select Recording Method...50 4.1.1 Ambulatory Studies...50 4.1.2 Attended Studies...51 4.2 Install or Charge the Batteries...51 4.3 Insert the Compact Flash Card...53 4.4 Connect Accessories...53 4.5 Connect Electrodes and Sensors...54 4.5.1 Referential Inputs...54 4.5.2 Bipolar Inputs...55 4.5.3 Connecting Input Adaptors...55 4.5.4 PSG Input Adaptor Set...57 4.5.5 Electrode Input Adaptor...58 4.5.6 Sensor Input Adaptor...58 4.5.7 REF / GND Adaptor...60 4.6 Commence Study...61

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Table Of Contents 4.6.1 Ambulatory Studies...61 4.6.2 Attended Studies...63 4.7 Example PSG Electrode and Sensor Connection...64 4.7.1 REF and GND Electrodes...64 4.7.2 EOG Electrodes...65 4.7.3 EEG Electrodes...66 4.7.4 ECG Electrodes...67 4.7.5 Chin EMG Electrodes...68 4.7.6 Leg EMG Electrodes...69 4.7.7 Airflow Sensor...70 4.7.8 Respiratory Bands...71 4.7.9 Microphone...72 4.7.10 Oximeter Probe...72 4.7.11 Position Sensor...74 4.8 Cleaning...75 4.8.1 Contamination With HIV, Hepatitis Or CJD...75 4.8.2 Damage Or Deterioration...75 4.8.3 Siesta Recording Unit...75 4.8.4 Snap Leads For Disposable Electrodes...75 4.8.5 Gold Cup Electrodes, Position Sensor, Airflow Sensor...76 4.8.6 Oximeter Probe...77 4.8.7 Abdominal And Thoracic Respiratory Bands...78 4.8.8 Nasal Cannula...78 4.9 Transfer Study...78 4.10 Review, Analysis and Report...79 5

USING SIESTA FOR EEG STUDIES...81 5.1 Select Recording Method...82 5.1.1 Ambulatory Studies...83 5.1.2 Attended Studies...84 5.2 Install or Charge the Batteries...84 5.3 Insert the Compact Flash Card...86 5.4 Connect Accessories...87 5.5 Connect Electrodes...87 5.5.1 Electrode Input Adaptors...88 5.5.2 Connecting Input Adaptors...88 5.5.3 Reference Input Adaptor...91 5.5.4 Electrode Inputs Adaptor...91 5.6 Commence Study...92 5.6.1 Turn the Siesta On...92

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Table Of Contents 5.6.2 Launch Profusion EEG...92 5.6.3 Check Signal Quality and Start Recording...93 5.7 Example EEG Study Electrode Connections...94 5.7.1 REF and GND Electrodes...94 5.7.2 EEG Electrodes...95 5.7.3 ECG Electrode...96 5.8 Cleaning...96 5.9 Transfer Study...96 5.10 Review, Analyse and Report...97 6

SIESTA PARTS...99 6.1 Recorder and Accessories...99 6.2 Electrodes and Sensors...102

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SIESTA SPECIFICATIONS...105 7.1 System Classification...105 7.2 System Environmental Requirements...105 7.2.1 Transport And Storage Conditions...105 7.2.2 Operating Conditions...105 7.2.3 Electromagnetic Compatibility...106 7.3 Physical...109 7.3.1 Recording Unit...109 7.3.2 Power Supply / Battery Charger...110 7.4 Power Source...110 7.4.1 Recording Unit...110 7.4.2 Power Supply / Battery Charger...110 7.5 Status Indicator...111 7.6 Radio Interface...111 7.7 Infra Red Interface...111 7.8 Internal Data Storage...112 7.9 Patient Inputs...112 7.9.1 DC capable channels...112 7.9.2 Standard channels...113 7.9.3 Selectable high pass filter channels...114 7.9.4 Oximeter (optional, see 7.10)...115 7.10 Expansion Ports...115

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C H AP TE R

1

Before You Begin

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The Siesta 802a and Safiro User Guide contains procedures and information for you to work with the Compumedics Siesta 802a, part number 8007-0024-02, or Safiro, part number 8007-0027-02, physiological recorders. It is a member of a set of several user guides designed to enhance your knowledge of the Compumedics Siesta system. Throughout this user guide the term Siesta is used to refer to either the Siesta 802a or Safiro device unless it is necessary to distinguish between them. In this case either Siesta 802a or Safiro is used as appropriate.

1.1 Limited Warranty – Hardware Compumedics Limited warrants each new device to be free from defects in workmanship and materials under normal use and service for a period of twelve (12) months from the date of shipment. Compumedics’ sole obligation under this warranty will be to repair or replace, at its option, products that prove to be defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth herein, seller makes no warranties, either expressed or implied, including the implied warranties of merchantability and fitness for a particular purpose. The warranty is not assignable. The warranty is invalidated if anyone other than Compumedics Limited or an authorised service agent attempts to repair or disassemble the unit.

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1.2 Limited Warranty – Electrodes, Sensors And Leads Compumedics Limited warrants each of the Products as free from material defect for a period of three (3) months from the date of delivery to the Distributor. During such period of three (3) months as aforesaid, Compumedics will replace without charge any component found to be materially defective and shall be responsible for all labour or other charges involved in repairing the Product(s) provided that Compumedics shall not be liable to replace components which are defective due to accident or misuse.

1.3 Safety And Effectiveness Considerations Sleep or neurological studies should only be carried out under the recommendation of a physician. This device is intended for use by persons trained in professional health care. The operator must be thoroughly familiar with the information contained in this User Guide before using the equipment. Do not use in conditions where vibrational stresses are excessive. Do not use in excessively unhygienic locations. Do not operate the equipment at ambient temperatures above +40ºC or below 10ºC (+104ºF and +50ºF respectively). Do not use in conditions where the device may be exposed to liquids (e.g. in shower).

1.4 Transport And Storage Conditions -10OC (+14OF) to 50OC (+122OF) 20 to 90% relative humidity, noncondensing.

1.5 Indications For Use The Siesta is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements Page 2

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to assist in the diagnosis of various sleep disorders or neurological disorders. The Siesta is designed for use in a hospital or other clinical environment. The Siesta is only to be used under the direction of a physician.

1.6 Contraindications Discontinue use if the patient displays distress, discomfort or adverse reaction to electrode and/or sensor attachment. Discontinue use if the patient perspires excessively. This may cause signal distortion. The Siesta is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

1.7 Labelling Definitions Where the following symbols appear on equipment according to IEC60601-1 / EN60601-1 they have the following definitions: Where you see this symbol on any device label it means “Attention, consult ACCOMPANYING DOCUMENTS”. Where you see this symbol on any device label it means “Type CF Applied Part”. Where you see this symbol on any device label it means “Type BF Applied Part”. Where you see this symbol on any device label it means “Type B Applied Part”. Where you see this symbol on any device label it means “Class II Equipment”.

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Before You Begin Where you see this symbol on any device label it means “RF electromagnetic energy emitted for diagnosis or treatment”.

1.8 Warnings And Cautions This symbol is used to indicate a WARNING. These highlight potentially harmful (to the patient or operator) situations. This symbol is used to indicate a CAUTION. These are conditions which may lead to equipment damage, malfunction or inaccurate operation. WARNING

The Siesta should not be used in the presence of flammable liquids or gasses. This may present an explosion hazard. Do not connect sensor lead wires into electrical outlets. Lead wire contact with electrical outlets presents a serious shock hazard. Pacemaker Patients – Heart rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon heart rate meters. Burns may occur at the electrode sites when the Siesta is used in conjunction with high frequency surgical or diathermy equipment due to high frequency currents flowing in the electrode lead wires. To minimise this risk: ●

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the electrodes should be positioned as far as practical from the patient electro-surgical equipment connections or the electro-surgical site on the patient use bipolar electro-surgery if possible use as low power as possible for the electrosurgical procedure in order to minimise the current. Siesta 802a and Safiro User Guide © Compumedics Limited 2013

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The equipment is not serviceable by the User's service personnel. The Siesta should under go regular electrical safety testing in accordance with your hospital's medical equipment routine testing procedures. This should be done at least annually. The Siesta does NOT have defibrillator protected patient circuits. If the patient needs to be de-fibrillated, remove all patient connected leads from the Siesta before activating the defibrillator. This product contains batteries which must be disposed of properly. Local, state or national laws my prohibit disposal of batteries in ordinary trash. Consult your local waste authority for information regarding available recycling and/or other disposal options. All external devices must be connected to the Siesta expansion ports prior to making any patient connections to the Siesta. Failure to do so may present a patient safety hazard. Do not connect unterminated interface leads to the Siesta. Doing so may present a patient safety hazard. CAUTION

Operation may be affected in the presence of strong electromagnetic sources such as electro surgery equipment. Remove any batteries from the Siesta if the equipment is not likely to be used for some time. The Siesta must be powered off before connecting or disconnecting external modules or the XPOD oximeter from the expansion ports. Failure to do so may damage the Siesta. Use only the sensors and electrodes supplied with or specifically intended for use with the Siesta. Failure to do so may result in invalid study data. Compumedics recommends the patient be supervised at all times during a study to prevent possible injury due to excessive patient movement.

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1.9 Prescription Device CAUTION

U.S. Federal law restricts this device to sale by or on the order of a physician.

1.10 Placement of Equipment Do not operate the Siesta near flammable or explosive gases or materials.

1.11 Interference The Siesta records physiological electrical signals which can be influenced by external electrical interference. Filtering techniques can be used to reduce the impact of external sources of interference. However, by being alert to signal interference, the potential effect of interference can be minimised. Keep the Siesta at least one metre (three feet) away from all electrical appliances. Examples of these include TV sets, electric blankets, air conditioners, microwave ovens, cordless and cellular telephones and walkie-talkies. Interference to physiological signals could be caused by strong transmitter signals such as TV, radio, airport, police, fire and ambulance stations. If recording will occur within two kilometres (1.3 miles) of one or more of these sources, then ask Compumedics Product Support to help you to determine if your system will operate properly. Synthetic fabric from draperies or carpets can cause interference due to static electricity. Touching an electrically conductive and earthed object before handling the patient or the Siesta can prevent interference from static charges.

1.12 Manufacturer's Recommendations Use only Compumedics supplied accessories with the Siesta. Be sure to read, understand and follow the instructions in this User Guide and others that come with the system and its components. Page 6

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1.13 Cleaning Unless specified otherwise within these instructions follow the manufacturer's recommendations and instructions for reusing, cleaning, disinfecting or sterilising sensors, sensor cables and monitoring equipment used with the Siesta. Always disconnect the components from all electrical power sources when cleaning the Siesta system or any of its accessories. Do not autoclave, gas or pressure sterilise any of the Siesta components. If any liquid is spilled on any Siesta component discontinue using it until it is determined that the component can be safely operated. Contact Compumedics Product Support or your authorised representative for assistance.

1.14 Wiring WARNING

Do not connect sensor lead wires into electrical outlets. Lead wire contact with electrical outlets presents a serious shock hazard.

Keep children and pets away from the Siesta. Children or pets could accidentally disconnect the equipment or cause other incidents. Do not allow the sensor wires or connecting cables to become tangled, coiled, crossed or wrapped around the patient's neck, arms or legs. This condition may cause strangulation. Compumedics recommends bundling electrode and sensor lead wires and using tape to hold them in place. Handle sensor wires carefully to prevent them breaking inside the insulation. Always grasp and pull wires at the strain relief area when disconnecting them from the Siesta.

1.15 Care Do not drop any components of the Siesta system. If a component is dropped discontinue using it until it is determined that the

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component can be safely operated. Contact Compumedics Product Support or your authorised representative for assistance.

1.16 Product Support If you have a question regarding the correct use of the Siesta and/or any of its components first refer to the relevant sections in this User Guide for the solution. If you are unable to find the answer in this User Guide contact Compumedics Product Support on: Australia New Zealand USA International

1800 244 773 0800 888 015 877 294 1346 +61 3 8420 7396

or your authorised representative. If you call you should be close to the product so that questions by trained Compumedics technicians can be answered efficiently. You should also have this manual at hand. When you call please provide the following information: ● ● ● ● ●

The version of software and operating system being used. If applicable the compact flash card manufacturer, model number and capacity. A description of what happened and what you were doing when the problem occurred. The exact wording of any messages that appeared on your screen. A description of any attempts made to fix the problem.

Repairs of Compumedics Limited equipment under warranty or service contracts must be made at authorised repair centres. If the equipment needs repair contact Compumedics Limited service department to request an RA Number (Return Authorisation). When calling have the device model and serial number ready. Service items received without an RA number may be returned to the sender or remain un-repaired until such time as a number is raised.

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If you need to ship the equipment pack it and its accessories carefully to prevent shipping damage. All relevant accessories should accompany the equipment. Compumedics Service Addresses Compumedics Ltd 30 – 40 Flockhart Street Abbotsford, VIC., 3067 AUSTRALIA

Phone: +61 3 8420 7300 Fax: +61 3 8420 7399

Compumedics USA 6605 West WT Harris Blvd. Suite F Charlotte, NC 28269 USA

Phone: Fax:

+1 704 749 3200 +1 704 749 3299

Compumedics European Authorised Representative Compumedics Germany GmbH Josef-Schüttler-Str. 2 Phone: +49 7731 79 769 0 D-78224 Singen Fax: +49 7731 79 769 99 GERMANY Compumedics E Mail Address Compumedics can also be contacted by sending e mail via the Internet. This will be most beneficial to international users. The Compumedics e mail address is: [email protected] Compumedics Home page Visit Compumedics home page on the World Wide Web at: http://www.compumedics.com

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2

Introducing Siesta 802a and Safiro

The Siesta system is a multi-functional, ambulatory recording device for physiological data. It enables recording, monitoring, storage and transfer of up to 32 physiological data channels, such as brain, heart and muscle activity, eye movement, breathing, and body movements. In addition an expansion interface allows connection of an oximeter for heart rate and oxygen saturation as well as supporting up to 16 external DC signal inputs for recording the output of other devices such as pH meters. There are applications for the Siesta system to assist in neurological and sleep disorder diagnoses. Using the latest in networking technology, investigations can be conducted at any distance, from the room next door to the other side of the world.

2.1 System Components A Siesta system is made up of several components. The primary components are discussed here, while a complete listing can be found in chapter 6. 2.1.1 Recording Unit The Siesta recording unit, shown in figure 2-1, provides the following functions: ●

32 user-definable input channels for flexible physiological monitoring, allowing a variety of signals to be recorded.

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Chapter 2 ●

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Introducing Siesta 802a and Safiro A built in compact flash card interface for data storage and convenient transfer to the review workstation. There is no proprietary hardware required to transfer the study data. A built in 802.11a/b/g compatible wireless LAN allowing for remote monitoring and configuration of the study parameters as well as remote data collection. The Siesta 802a wireless supports infra-structure or ad-hoc connection modes, no security, WEP, WPA or WPA2 security (PSK only, EAP is not supported) and two power savings modes. The wireless used in the Safiro only supports ad-hoc connection mode, WEP (or no) security and does not support any power saving modes. Flexible power options with the unit supporting both rechargeable and non-rechargeable batteries as well as an external mains powered combination power supply and battery charger. Two expansion interfaces for connection of an oximeter, event button or expansion modules (for external DC inputs or pressure and flow).

Figure 2-1: Siesta Recorder To turn the Siesta recorder on press and hold the power button, indicated by , until the status indicator lights. To turn the Siesta off press and hold the power button until the status indicator goes out (at least 5 seconds). The operating status of the Siesta recorder is shown via the status indicator as follows: Off:

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Siesta is turned off.

Siesta 802a and Safiro User Guide © Compumedics Limited 2013

Introducing Siesta 802a and Safiro Off (charger connected): Solid Green: Solid Red:

Flashing Orange: Flashing Green:

Alternating Green Orange:

Flashing Red:

Chapter 2

Siesta is turned off and the battery is fully charged. Siesta is turned off but the battery is charging. An unrecoverable error has occurred. It is necessary to turn the Siesta off and back on again to continue operation. Siesta is turned on and idle (not transmitting or recording data). Siesta is turned on and capturing data which is transmitted via the wireless interface and/or recorded to the device local compact flash card. Siesta is turned on and capturing data for transmission over the wireless interface however the wireless connection is not currently active. Usually this means that the Siesta is out of wireless range of any access point devices. A compact flash card error has occurred. It is necessary to remove and re-install the compact flash card to continue.

Battery charging status is not indicated, at the device, while the Siesta recording unit is turned on.

2.1.2 Batteries The Siesta may be powered from either 4 AA alkaline batteries or a re-chargeable 1800 mAh NiMH (Nickel Metal Hydride) battery pack, Compumedics part number 0300-0024-00. The Siesta is able to determine automatically if AA batteries or the rechargeable battery pack is installed. If the rechargeable battery pack is installed it is automatically charged whenever the Siesta is connected to the power supply / battery charger unit (see section 2.1.3).

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