ALGO 5 Newborn Hearing Screener User Manual Ver J Aug 2011

© 2011 Natus Medical Incorporated All rights reserved. Distribution of contents to persons other than custom ers of Natus is strictly prohibited. The content of this m anual m ay change without notice. ALGO ® is a registered tradem ark of Natus Medical Incorporated. Microsoft, W indows, and the W indows logo are tradem arks or registered trademarks of Microsoft Corporation. Adobe, OZ, HiTrack and all other tradem arks are the property of their respective holders.

Natus Medical Incorporated One Bio-logic Plaza Mundelein, IL 60060 USA Telephone +1 (650) 802-0400 Fax +1 (650) 802-0401 www.natus.com

Natus Europe GmbH Bärmannstrasse 38 D-81245 München Germany

CONFIDENTIAL PROPERTY OF NATUS MEDICAL INCORPORATED MEDICAL INCORPORATED ALL RIGHTS RESERVED

Table of Contents Table of Contents... v System Description... 1 Intended Use... 1 Safety Information... 2 Explanation of Terminology... 2 Explanation of Symbols... 2 Electrical Safety... 3 Electromagnetic Emissions... 3 Precautionary Information... 7

Overview of the ALGO Screening Technology... 9 Pass/Refer Criteria... 9

Screener Components and Accessories... 10 Screening Module... 10 Cable Assemblies... 12 Screening Station (Cart)... 15 ALGO Screening Supplies... 16

User Interface... 17 Interface for the ALGO Screener... 17 Note on Screen Appearance... 17 Login Window... 18 Main Window... 18 Patient Data Window... 20 Risk Factors Window... 21 Screening Method Selection Window... 22 Baby Preparation Window... 23 Screening Window... 24 Preferences Window... 25 Equipment Check Window... 26 audble® Data Management Window... 27 Help Windows... 28

Using the System... 28 Operating Instructions... 31 Overview of Screening Procedure... 31 Selecting a Baby... 32 Important Notes about Proper Baby Selection... 33

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Setting Up the Screener... 33 Starting Up the Screener... 34 Enter Patient Information... 35

Preparing the Baby for Screening... 39 Running the Screening Procedure... 45 Right/Left Simultaneous Screening Method... 46 Pausing a Screening... 49 Right/Left Sequential Screening Method... 50 Single-Ear Screening Method... 51

Cleanup... 51 Proper Shutdown Procedures... 53 Cable Storage... 54 Troubleshooting... 55 Using Online Help... 55 Help Topics:... 55 Using Help... 56

Artifact Rejection Systems... 56 Impedance and Sensor Problems... 57 Check Screener... 57 Check Environment... 59 Check Baby... 59

Prepping Techniques... 60 Reprep Method... 61

Ambient Interference... 63 Check Screener... 63 Check Environment... 64 Check Baby... 64

Myogenic Interference... 65 Check Screener... 65 Perform an Impedance Check... 65 Check Environment... 66 Check Baby... 67

Understanding a “REFER” result... 67 Check Screener... 68 Check Environment... 68 Check Baby... 69

Error Messages and System Failure... 69 Printer Error... 69 System Error... 69 Time Limit... 70

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Equipment Check... 70 Artifact Check... 72 Acoustic Check... 73 Impedance Check... 73

Database Corruption and Improper Shutdown Dialogs... 73 Corruption issues... 75 Subsequent uses of the device... 76 Update and Backup procedures... 77

Service and Maintenance... 79 Cleaning the Screener... 79 Inspecting Accessory Parts... 80 Loading Printer Labels... 81 Correcting a Printer Jam... 82 Technical Service and Calibration... 82 ALGO Screener Calibration Requirements... 82 Calibration Considerations... 83 Corrective Service/Maintenance... 83

Preferences and Profiles... 85 ALGO 5 Preferences... 86 Common Settings... 86 Screening Options... 87 User and Session Management... 88 Printer Settings... 89 Overall Result Computation... 89

audble Data Management Preferences... 91 Single Patient Layout Editor... 91 Risk Factor Editor... 95 Report Template Editor... 97 Pick List Editor... 100 Export Format and Network Settings... 101

Field Label Editor... 102 User Management... 103 Create new user... 104 Edit User... 104 Activate or Deactivate User... 105

Profile Manager... 105 Create New Profile... 105 Edit Profiles... 106

System Control... 106 Label Printer... 107 Letter Printer... 107

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Date and Time Control... 107 Wireless LAN... 108 System Info... 109 Update... 110 Backup... 110 Restore... 111 Archive Data... 111

audble® Data Management... 115 Note on Configuration... 115 Example Data... 115

Finding and Displaying Patient Records... 115 Editing Patient Records... 117 Adding Patient Records... 118 Screen Baby... 118 Exporting Data... 118 Importing Data... 120 Resolving Import Conflicts... 121

Selecting and Printing Letters and Reports... 122 Printing Labels... 123 Printing Letters and Reports... 123 Patients Reports and Letters... 123 Statistics Reports... 123

Customizing Data Display... 124 Appendix 1... 125 Storing ALGO 5 Screener Cables... 125 High Risk Indicators... 126 Specifications... 126 Sweep Rates... 126 Power Supply... 126 Classifications... 127

Glossary... 127 Appendix 2... 129 ALGO 5 Software License Agreement... 129 List of Figures... 133 Index... 135

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System Description The ALGO® 5 Newborn Hearing Screener User Manual is designed to educate you on the proper and safe use of the product. This chapter covers several important introductory topics, including: •

Intended use: see “Intended Use” on page 1

•

Safety information: see “Safety Information” on page 2

•

Overview of the ALGO screening technology: see “Overview of the ALGO Screening Technology” on page 9

•

Screener components and accessories: see “Screener Components and Accessories” on page 10

•

User interface: see “User Interface” on page 17

•

Using the system: see “Using the System” on page 28

For installation and assembly information, see the Service Manual and accessory part installation notes.

Intended Use The ALGO 5 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® (Automated Auditory Brainstem Response) technology. The ALGO 5 also includes Natus Medical’s audble® Data Management software pre-installed. The screener is intended for babies between the ages of 34 weeks (gestational age) and six months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening. The screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good health. A typical screening process can be completed in 15 minutes or less. Sites appropriate for screening include the well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office.

Contraindications for Use: Screening an infant with known neurologic conditions should be done only under well-informed medical and/or audiological supervision.

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System Description

Safety Information

Safety Information

Explanation of Terminology

This manual presents three types of precautionary information. The three types of statements carry equal weight; that is, they are of equal importance to the safe and effective use of the device. Each statement is categorized by using an introductory word in boldface as follows: WARNING: Identifies conditions or practices that might present danger or possible injury to the patient and/or user. IMPORTANT:

An instruction provided to help ensure correct clinical results.

CAUTION: An instruction that, if not followed, can result in a condition that could damage the screening device. Other explanatory information is highlighted with the word Note. Information in this category is not considered precautionary. Note: Background information provided to clarify a particular step or procedure.

Explanation of Symbols Symbol

Meaning

Attention, consult product documentation Consult instructions for use Type BF rate for patient-applied parts Power WEEE Directive (Waste from Electrical and Electronic Equipment Directive) Symbol - Product should not be disposed of in normal waste Manufacturer Fuse Direct current AC/DC adapter Serial port

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Electrical Safety

System Description Safety Information The ALGO® 5 hearing screener is a Class A device (CISPR Classification), which is allowed in domestic establishments when used under the jurisdiction of a health care professional. This device may cause radio interference, in which case adequate measures may be required to prevent interference. The ALGO® 5 screener complies with the following electrical safety standards: •

UL2601-1

•

CAN/CSA-C22.2 601-1

•

EN60601-1

•

EN60601-1-2

•

EN60601-1-4

•

Electrical rating Class I, Type BF

Electromagnetic Emissions Guidance and manufacturer’s declaration - electromagnetic emissions The ALGO 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the ALGO 5 should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic environment guidance

RF emissions CISPR 11

Group 1

The ALGO 5 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

The ALGO 5 is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating ALGO 5 or shielding the location.

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Safety Information

Guidance and manufacturer’s declaration - electromagnetic immunity The ALGO 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the ALGO 5 should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD)

Or a batt ± 6 kV contact

± 6 kV

IEC 61000-4-2

± 8 kV air

± 8 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Electrical fast transient/burst

± 2 kV for power supply lines

± 2 kV

IEC 61000-4-4

± 1 kV for input/output lines

± 1 kV

Surge

± 1 kV line(s) to line(s)

± 1 kV

IEC 61000-4-5

± 2 kV line(s) to earth

± 2 kV

Voltage dips, short interruptions, and voltage variations on power supply input lines

<5 % UT (>95 % dip in UT) for 0,5 cycle

100% dip

40 % UT (60 % dip in UT) for 5 cycles

60% dip

IEC 61000-4-11

70 % UT (30 % dip in UT) for 25 cycles

Power frequency (50/60 Hz) magnetic field

30% dip

<5 % UT (>95 % dip in UT) for 5 s

100% dip

3 A/m

3 A/m

IEC 61000-4-8

Mains power quality should be that of a typical commercial or hospital environment

Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment. If the user of the ALGO 5 requires continued operation during power mains interruptions, it is recommended that the ALGO 5 be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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System Description Safety Information

Guidance and manufacturer’s declaration - electromagnetic immunity The ALGO 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the ALGO 5 should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the ALGO 5, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2,5 GHz

3V

3, 5 d = --------V1

P

3, 5 d = --------E1

P 80 MHz to 800 MHz

7 d = -----E1

P 800 MHz to 2,5 GHz

3 V/m

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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System Description

Safety Information

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environmnet due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the ALGO 5 is used exceeds the applicable RF compliance level above, the ALGO 5 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ALGO 5.

b Over the frequency range 150 kHz to 80 MHz, field strenghts should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the ALGO 5 The ALGO 5 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ALGO 5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ALGO 5 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to the frequency of transmitter m 150 kHz to 80 MHz 3, 5 d = --------V1

P

80 MHz to 800 MHz 3, 5 d = --------E1

P

800 MHz to 2,5 GHz 7 d = -----E1

P

0,01

0.12

0.12

0.20

0,1

0.37

0.37

0.63

1

1.17

1.17

2.0

10

3.69

3.69

6.32

100

11.67

11.67

20

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Precautionary Information

System Description Safety Information

Read all sections of this user manual carefully before attempting a hearing screening with an infant. IMPORTANT: Incorrect use of the screener and its accessories, or the use of parts and accessories that are not manufactured or supplied by Natus Medical Incorporated can lead to incorrect results. WARNING: Do not use your screener if there is any suspicion that it is not functioning properly, or if any parts appear damaged. Contact Natus Medical Technical Service or your authorized service representative. WARNING: Any misuse of the earphones or the earphone cable (that is, any use other than that described in this manual) may result in screening at unknown and uncontrolled decibel levels. WARNING: Do not remove the computer from the screening system unless your service representative specifically instructs you to do so.There are no user-serviceable parts inside the computer aside from replacement of the RTC Battery. Installation, modification, or replacement of any computer accessories, circuit cards, components, or alteration of the CMOS configuration memory may compromise the safe and effective operation of this device and will void the warranty. CAUTION: There is no user access to the computer operating system. Never attempt to load software into the system that has not been supplied or approved by Natus Medical. Attempting to load any software, computer accessory, or other medical device that has not been provided or approved by Natus Medical is expressly prohibited and will void the warranty. CAUTION: The label printer with the ALGO 5 screener uses a thermal print mechanism. This technique avoids the use of inks and ribbons; however, because the paper is heat-sensitive, it is possible for a label to darken if exposed to high heat or very bright light for an extended period of time. It is also possible for certain plasticizers in some plastic binders to cause a reaction which results in the image fading over time. Care should be taken by the institution to back up screening results to ensure long-term record retention. WARNING: Verify the maximum load for all multiple portable socket-outlets does not exceed 600VA. WARNING:

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Safety Information

WARNING: Never connect an extension cord to the multiple portable socket-outlets. WARNING: Do not use the multiple portable socket-outlets to power any equipment that is not a part of the ALGO 5 system. Adding other equipment may increase the current amount of leakage and exceed the safety limit. WARNING: Do not connect non-medical electrical equipment directly to a wall outlet if the Natus ALGO 5 system is using a multiple portable socket-outlet with a separating iso-transformer. The additional equipment may increase the current amount of leakage and exceed the safety limit. WARNING: Do not connect other equipment to the ALGO 5 system that is not part of the system. The additional equipment may increase the current amount of leakage and exceed the safety limit. CAUTION: Always power off the device via the computer menu selections available. Do not simply turn off the power switch nor unplug from the wall prior to a proper shutdown. The proper shutdown procedure includes navigating to the Main Window, choosing Exit and then either Power Off (and confirm your selection) or Hibernate.” Wait for the computer to complete the action chosen. Only then should the device be switched off via the switch at the bottom of the column, and then, if desired, be unplugged. Please refer to Shutdown Procedures on Page 49. CAUTION: Failure to shut down properly may lead to problems with the stability of the database containing patient data. Patient data could potentially be lost if the device is shut down improperly. Care should be taken to ensure all staff are following proper shutdown procedures. Please refer to Shutdown Procedures on Page 49.

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System Description Overview of the ALGO Screening Technology

Overview of the ALGO Screening Technology The ALGO screener delivers thousands of soft click sounds at 35 dB nHL (‘normal hearing level’ scale) to a newborn’s ears through disposable earphones. Each click evokes a series of identifiable brain waves from a special area of the baby’s brain called the auditory brainstem. This brain wave activity is called the auditory brainstem response (ABR). The ABR is the most accurate measure of auditory sensitivity in the newborn population.1 The instance in which the screener delivers a click and receives a response to that click is called a sweep. Sensors on the baby’s skin pick up the brain wave signals and transmit the signals to the screener. Since these signals are very small compared to other electrical activity in a baby’s brain, it is important to place the sensors correctly and ensure that the baby is sleeping quietly or is in a quiet state. The screener uses advanced signal processing technology to separate the ABR waves from background noise and other brain activity. These brain waves are averaged and checked to see if they are consistent with a pattern called a template. The template is derived from ABRs of normal-hearing infants. The screener must detect the ABR waveform with high statistical confidence to determine that a response is present. The screener’s design offers simple user interaction with on-screen instructions. The screener is part of a mobile screening station and can be used easily at an infant’s cribside. The included label printer automatically prints results on a self-adhesive label, which can be affixed directly in the medical chart. An optional letter printer can also be used to print patient results, reports, and letters. The screener can be operated by trained volunteers and other trained nonmedical personnel. Users can track screening data with the integrated ALGO audble® NHS Data Management System software. (See “audble® Data Management ” on page 115)

Pass/Refer Criteria

During the screening process, the screener measures the probability of two conditions: a response-plus-noise condition (PASS) and a pure noise or no response condition (REFER). To grant a PASS or REFER result, the screener measures the probability that the infant’s response is present. Pass Condition: The screener will generate a PASS result when it collects sufficient data to establish with >99% statistical confidence that an ABR signal is present and consistent with the template at a minimum of 1000 sweeps. Refer Condition: The screener will continue to collect data up to 15,000 sweeps. If it has not established with >99% statistical confidence that the ABR signal is present at 15,000 sweeps, the screener will generate a REFER result. 1. Jacobson J et al Jacobson J et al. (1990) Automated and conventional ABR screening techniques in high-risk infants. Journal of American Academy of Audiology, 1(4): 187–195.

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System Description

Screener Components and Accessories

Screener Components and Accessories The screening system is made up of several primary components:

Screening Module

•

Screening module with computer/monitor and keyboard

•

Label printer

•

Cable assemblies

•

Screening station (cart) for component storage and transport

•

Screening and accessory supplies

The screening module combines a computer with a cart. This cart contains a special set of customized electronic components that incorporate the AABR technology. The monitor display presents windows containing command buttons, baby illustrations, instructions, screening parameters, and screening results. You operate the screener by using command buttons along with the keyboard, touch screen (if available), and/or pointing device to select and begin each procedure. Results are recorded within the computer and can also be printed on a label or report by a printer. The screener preferences can be set to print the results onto a label automatically at the end of a test. A label printer is included as a standard part of the package; a letter-size printer for reports and letters is an optional addition. You will find a CD ROM drive on your computer. The CD-R drive, or a USB flash drive, allows you to save a copy of the results as a computer file. The CD ROM drive also allows you to install Natus Medical-approved software updates.

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System Description Screener Components and Accessories

Figure 1-Screening module and cart

Note: Controls for brightness, contrast, and color adjustment are adjusted by pressing the “Menu” button on the front of the monitor display. Use the arrow buttons, along with the “SEL(ect)” and “Exit” buttons to cycle through the menu choices. Adjust these controls to improve display screen visibility, if desired. Note: Location of controls may differ from the description above, depending on the computer used.

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System Description

Screener Components and Accessories

Cable Assemblies

The earphone cable (also known as the Acoustic Transducer Assembly 5 or ATA 5) consists of two cables each with plastic transducer housings on one end that merge into a single cable. Each transducer housing holds a speaker to generate the click sounds and a microphone to listen for ambient noise. The transducer housings fit into the earphones and are identified with red for the right ear and blue for the left ear. Figure 2-Earphone (ATA) cable

The sensor cable includes three individual cables, each with a colored clip at one end, that merge into one cable before connecting to the preamplifier box. CAUTION: Do not allow transducers to dangle from the screener, or to bang against the side of the cart. Never swing the earphone cable or strike the transducers against a hard surface. Shock to the transducers can result in damage to their sensitive acoustic components.

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System Description Screener Components and Accessories

Figure 3-Sensor cable, also called the Patient Cable Assembly 5, or PCA 5

Both the earphone (ATA) cable and the sensor (PCA) cable plug into the preamplifier cable which plugs into the DSP box. The clips attach to the sensors on the baby’s skin and transmit the baby’s brain wave signals back to the screener. When not in use, the preamplifier and sensor cable should be kept in the storage drawer, placed in the cable storage tray, or hung on the cable hanger at the back of the cart. Note: When not in use, transducers and the earphone cable can be stored in the drawer under the keyboard, hung on the forks at the back of the cart, or placed in the cable storage tray.

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System Description

Screener Components and Accessories

Figure 4-Preamp cable

CAUTION: When inserting the Preamp cable into the DSP, ensure that the alignment arrows match up to allow proper mating. The connection will not require force and an audible click will be heard with proper seating of the connector. Do not force the connection. Do not twist connection. ALGO 5 software version 1.3 and later requires the use of a newer version preamp. Earlier version preamps will not function with these software versions. A warning message will appear. Please contact Natus Technical Service if this message appears.

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