Natus ALGO 5 User manual

ALGO® 5 Newborn Hearing Screener
____________________________________________________________________________________
Service Manual
ALGO® 5 Newborn Hearing Screener
____________________________________________________________________________________
Service Manual
Caution: Federal Law (U.S.) restricts this device to sale or use by or on the order of a physician (or properly licensed practitioner).
AABR, ALGO, Flexicouplers, Jelly Tabs and Natus are registered trademarks of Natus Medical Incorporated.
Windows and Microsoft are registered trademarks of Microsoft Corporation
© Natus Medical Incorporated. April 2008 This manual may not be reprinted or copied in whole or in part without written consent from
Natus Medical Incorporated. The content of this manual may change without notice.
Natus Medical Incorporated Technical Service +1 888 496 2887 1501 Industrial Road Technical Service Fax +1 650 802 8680 San Carlos, CA 94070 E-mail: technical_service@natus.com
International Support - Please contact your local Distributor
Distributor locations can be found at www.natus.com
P/N 000976 Rev.A
Table of Contents
List of Figures and Tables..............................................................................................................................3
1. Introduction ............................................................................................................................................5
1.1. About this manual..........................................................................................................................5
1.1.1. Overview...............................................................................................................................5
1.1.2. Intended users......................................................................................................................5
1.1.3. Manual conventions..............................................................................................................5
1.2. Product description........................................................................................................................6
1.3. Pictorial introduction to the ALGO 5..............................................................................................7
1.4. Before you start...........................................................................................................................11
1.5. Contacting your Natus Technical Service...................................................................................11
2. Routine Maintenance Procedure.........................................................................................................12
2.1. Inspecting Accessory Parts.........................................................................................................12
2.2. Cleaning the ALGO 5..................................................................................................................12
2.2.1. Cleaning the Screener........................................................................................................12
2.2.2. Cleaning the cart ................................................................................................................13
2.3. Safety testing...............................................................................................................................13
2.3.1. Ground Integrity..................................................................................................................13
2.3.2. Earth leakage current.........................................................................................................14
2.3.3. Enclosure leakage current..................................................................................................14
2.4. Performance verification .............................................................................................................15
2.4.1. Equipment Check for the ALGO 5 screener.......................................................................15
2.4.2. Component tests ................................................................................................................20
2.4.2.1. General...............................................................................................................................20
2.4.2.2. ATA 5 Cable calibration due Warnings ..............................................................................21
3. Troubleshooting Guide.........................................................................................................................22
3.1. Troubleshooting the ALGO 5 ......................................................................................................23
3.2. Troubleshooting the Panel PC....................................................................................................25
3.2.1. Replacing the battery for the RTC (Real Time Clock) on the Panel PC.............................25
3.3. Troubleshooting the Isolation Transformer .................................................................................28
3.4. Troubleshooting the ATA 5 .........................................................................................................30
3.5. Troubleshooting the Preamp 5....................................................................................................31
3.6. Troubleshooting the PCA 5.........................................................................................................33
4. Technical Troubleshooting Guide........................................................................................................34
4.1. High Impedance..........................................................................................................................34
4.2. High Myogenic.............................................................................................................................35
4.3. High Refer Rate...........................................................................................................................36
4.4. High Ambient...............................................................................................................................37
5. Parts and Specifications ......................................................................................................................38
5.1. How to order parts.......................................................................................................................38
5.2. Parts list.......................................................................................................................................38
5.3. Specifications..............................................................................................................................40
6. Index ....................................................................................................................................................41
List of Figures and Tables
FIGURE 1: ALGO 5 — front view...................................................................................................................7
FIGURE 2: ALGO 5 — rear view (cover removed) ........................................................................................8
FIGURE 3: DSP Box.......................................................................................................................................9
FIGURE 4: Preamplifier 5 (Preamp 5)............................................................................................................9
FIGURE 5: Acoustic Transducer Assembly (ATA 5)....................................................................................10
FIGURE 6: Patient Cable Assembly (PCA 5)...............................................................................................10
FIGURE 7: Main Window .............................................................................................................................15
FIGURE 8: ALGO Check Kit.........................................................................................................................15
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FIGURE 9: Equipment check .......................................................................................................................16
FIGURE 10: DSP Box disconnected............................................................................................................17
FIGURE 11: Preamp 5 disconnected...........................................................................................................18
FIGURE 12: ATA 5 disconnected.................................................................................................................19
FIGURE 13: Equipment Check - Overview ..................................................................................................20
FIGURE 14: ATA 5 Cable calibration due Warnings....................................................................................21
FIGURE 15: Block Diagram wiring...............................................................................................................22
FIGURE 16: Troubleshooting the ALGO 5...................................................................................................23
FIGURE 17: Location of Panel PC outer shell screws.................................................................................25
FIGURE 18: View outer shell Panel PC .......................................................................................................26
FIGURE 19: Location of Battery on Motherboard Panel PC........................................................................26
FIGURE 20: Detail View RTC Battery on Panel PC.....................................................................................27
FIGURE 21: Open the power inlet module...................................................................................................28
FIGURE 22: Access to the fuse holder.........................................................................................................28
FIGURE 23: Fuse holder..............................................................................................................................29
FIGURE 24: Acoustic Check ........................................................................................................................30
FIGURE 25: Impedance Check....................................................................................................................31
FIGURE 26: Artifact Check...........................................................................................................................32
FIGURE 27: Impedance Check....................................................................................................................33
FIGURE 28: High Impedance.......................................................................................................................34
FIGURE 29: High Myogenic.........................................................................................................................35
FIGURE 30: High Refer Rate.......................................................................................................................36
FIGURE 31: High Ambient ...........................................................................................................................37
TABLE 1: Ground Integrity ...........................................................................................................................14
TABLE 2: Earth leakage current...................................................................................................................14
TABLE 3: Enclosure leakage current ...........................................................................................................14
TABLE 4: Parts List for Natus ALGO 5 system............................................................................................38
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1. Introduction
1.1. About this manual
1.1.1. Overview
This manual contains information needed for servicing the ALGO® 5 Newborn Hearing
Screener.
Description of the product and overview illustrations (Chapter 1)
Maintenance Procedure (Chapter 2)
Troubleshooting Guide (Chapter 3)
Troubleshooting Flowcharts (Chapter 4)
Installation and Assembly Instructions (Chapter Error! Reference source not
found.)
Parts and ordering information (Chapter 5)
Index
1.1.2. Intended users
This service manual is written for qualified biomedical technicians. It describes service tasks which could lead to injury, or which could damage the device, if attempted by a person without the requisite skills.
1.1.3. Manual conventions
Precautionary information is emphasized by being labeled as warning, caution or important. Other explanatory information is highlighted with the word Note.
Type of information Usage
Identifies conditions or practices that may result in injury or
WARNING
death to the patient and/or user. Warnings are boxed and preceded by a hazard symbol.
CAUTION:
Precedes an action that may result in damage to or malfunction of the device.
An instruction provided to help ensure correct clinical
Important!
results and provide quality assurance to the screening procedures.
Background information provided to clarify a particular step
Note:
or procedure. Information in this category is not considered precautionary.
Precautionary Information
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
ALGO® 5 Newborn Hearing Screener Service Manual P/N 000976 Rev.A
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lead to incorrect results. Do not use your screener if there is any suspicion that it is not functioning properly, or if
any parts appear damaged. Contact Natus Technical Service or your authorized service representative.
Warning! Please avoid practices that can compromise the safe and effective use of the ALGO 5:
Do not remove the Panel PC computer from the ALGO 5 unless your service representative specifically instructs you to do so. There are no user-serviceable parts inside aside from replacement of the RTC Battery. Installation, modification, or replacement of any circuit cards, or alteration of the CMOS configuration memory outside of Natus instructions, may compromise the safe and effective operation of this device and will void the warranty.
There is no user access to the computer operating system. Never attempt to load software into the ALGO 5 that has not been supplied or approved by Natus Medical. Attempting to load any software or to attach computer accessories or other medical devices that have not been provided or approved by Natus Medical is expressly prohibited and will void the warranty.
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! The ALGO 5 is not suitable for use in the presence of flammable Anaesthetic Mixtures with Air, Oxygen, or Nitrous Oxide.
Warning! The ALGO 5 is an electrically isolated system only when the unit is plugged in through the Isolation Transformer built into the cart and not connected to any other external system. If the device is to be connected to a hospital network, the optional LAN Isolator (P/N 040948) must be used between the Panel PC and the hospital network to maintain electrical isolation of the device.
1.2. Product description
The ALGO 5 consists of several major components:
Screening station (cart) for component storage and transport
Isolation Transformer (to electrically isolate AC mains voltage provided by
hospital from ALGO 5 main power)
Panel PC (the interface between the medical personnel and the equipment)
Acoustic Transducer Assembly 5 (ATA 5) - (calibrated earphones to deliver
clicks to the patient’s ears)
Patient Cable Assembly 5 (PCA 5) - (electrodes registering EEG signals from the patient)
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Preamplifier 5 (Preamp 5) - (amplifies signals from the electrodes, also serves as isolation for the patient)
DSP Box (processes digital signals from Preamp 5)
Label printer
Page printer (optional, available in inkjet or laser models)
Bar code scanner (optional)
LAN Isolator (optional)
1.3. Pictorial introduction to the ALGO 5
This section is meant to acquaint you with various views of the ALGO 5 that you will see in the course of troubleshooting and repairing it. The item names used in the Parts List (see Chapter 5) are used throughout the manual whenever parts are discussed.
Panel PC
DSP Box
Drawer for Disposables
Cart Column with Integrated
Cable Management
Isolation Transformer
FIGURE 1: ALGO 5 — front view
Keyboard
Label Printer
Shelf Space
Page Printer
(optional)
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Cart Column with
Integrated Cable
Management –
management for
ATA 5 & PCA 5
FIGURE 2: ALGO 5 — rear view (cover removed)
Rear View
DSP Box –
Rear View
Preamp Holder
Cable
Cables
Barcode Scanner
(optional)
Power Supply
for DSP Box
mounted in the
column
Power Supply
for Label Printer
mounted in the
column
Optional Power
Supply for Inkjet
Page Printer
Main Switch
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p
Panel PC
Communication
cable
DSP Serial Number Label on to
Status LED
Power
Socket
FIGURE 3: DSP Box
Preamp 5 Cable
FIGURE 4: Preamplifier 5 (Preamp 5)
Connector
Hook
PCA Socket
Preamp
Socket
ATA Socket
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FIGURE 5: Acoustic Transducer Assembly (ATA 5)
Blue Transducer:
left ear
Red Transducer:
right ear
Connector
Connector
Nape - White
Common - Green
Vertex - Black
FIGURE 6: Patient Cable Assembly (PCA 5)
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1.4. Before you start
Observe Electrostatic Discharge (ESD) precautions when handling, adjusting, or performing any procedure with the device internal
WARNING
components.
1.5. Contacting your Natus Technical Service
Should you encounter situations that are not covered by this Service Manual, contact a Natus Technical Service representative.
Please have your Natus device model and serial number available when calling Technical Service.
United States customers: Contact a Natus Technical Service Representative at: Technical Service +1 888 496 2887
Technical Service Fax +1 650 802 8680 E-mail: technical_service@natus.com
International Support: Please contact your local Distributor. Distributor locations can be found at www.natus.com
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2. Routine Maintenance Procedure
This chapter defines procedures for routine maintenance of the ALGO 5 screener. These
procedures must be performed after any of the following events and/or as prescribed by the institution’s maintenance schedule:
Institution first receives the ALGO 5 screener.
Foreign material or liquid has been deposited on the ALGO 5 screener.
ALGO 5 screener has been visually damaged or subjected to mechanical
shock (e.g. being dropped).
ALGO 5 screener has been submitted for maintenance or scheduled performance verification.
2.1. Inspecting Accessory Parts
Routinely inspect screener components as described below:
Inspect earphone cable for damage (tears, cracks, exposed wires, etc.)
Inspect sensor cable for proper connection to the Preamp 5, for worn or
broken insulation, and for looseness at the clips. Inspect Preamp 5 cable for damage.
Inspect power cord for fraying or other damage.
If the screener is frequently moved to different locations or subjected to heavy
use, check regularly for external damage.
Examine the Preamp 5 for cracks or dents that might have been caused by repeated banging against the side of the screener or the edge of a crib.
Replace accessories or have them repaired as needed.
Warning! Do not use the screener if you suspect that it is not functioning properly, or if any parts appear damaged. Contact Natus Technical Service or your authorized service representative.
2.2. Cleaning the ALGO 5
2.2.1. Cleaning the Screener
WARNING
To keep the screener clean, perform the following tasks regularly:
Remove dust from the screener’s exterior with a soft brush or cloth.
Clean the exterior case of the screener with a lightly water-dampened soft
cloth.
To clean the Panel PC, dilute a volume of glass cleaner with an equal volume of water. Spray a small amount of the diluted cleaner on a soft cloth and gently wipe the screen.
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Turn off power and unplug the screener before cleaning.
CAUTION: Press gently on the Panel PC display! Too much pressure can cause permanent damage. Do not spray diluted cleaner directly on the display.
Clean the sensor and earphone cables with a cloth dampened with water, isopropyl alcohol, or a 10% bleach solution. Do not stretch the cables. Delicate shielding in the wires can be damaged, resulting in electrical shorting. Refer to your hospital’s protocol for the frequency of cleaning equipment that comes into contact with the patient.
Wipe off any remaining dirt or spots on the screener and cables with a cloth dampened with a mild solution of commercial detergent, hospital cleaning agent and water, or isopropyl alcohol.
CAUTION: Do not spray or pour cleaners directly on the screener. Keep liquids, including cleaning fluid, away from the screener’s keyboard, earphone transducers, and other openings. Never spray cleaner directly onto the screener. Never use harsh or abrasive chemical products to clean the screener. Do not immerse patient cables or transducers in water or cleaning solutions.
2.2.2. Cleaning the cart
The cart may be cleaned with most mild, non-abrasive solutions commonly used in the hospital environment (e.g., diluted bleach, ammonia, or alcohol solutions).
The surface finish will be permanently damaged by strong chemicals and solvents such as acetone and trichloroethylene.
Abrasive material such as steel wool should never be used to clean any component of the cart.
Never submerge the cart base or allow liquids to enter any component of the cart. Wipe any cleaning agents off cart components immediately using a water­dampened cloth. Dry all components thoroughly after cleaning.
Damage caused by the use of unapproved substances or processes will not be covered by warranty. It is recommended that any cleaning solution be tested on a small area of the cart that is not easily visible to verify compatibility.
CAUTION: To clean or sterilize mounted instruments or accessory equipment, refer to the specific instructions delivered with those products. Consult your hospital’s infection control officer or epidemiologist.
2.3. Safety testing
The safety tests meet the standards and are performed in accordance with, IEC 60601-1, (Amendment 1, Amendment 2,) and UL 60601, for instruments as Class 1 and Type BF and ANSI/NFPA Standard 99.
Applicable tests for these standards are listed in following sections (2.3.1-2.3.3). Technicians must be familiar with the standards applicable to their institution and country.
2.3.1. Ground Integrity
1. Unplug the ALGO 5 power cord from the wall outlet. Make sure it is a 3-prong
power cord (with ground).
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