Service Manual
44 Pages
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© 2010 Natus Medical Incorporated All rights reserved. Distribution of contents to persons other than customers of Natus is strictly prohibited. The content of this manual may change without notice. ALGO® is a registered trademark of Natus Medical Incorporated. Microsoft, Windows, and the Windows logo are trademarks or registered trademarks of Microsoft Corporation. Adobe, OZ, HiTrack and all other trademarks 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) 802-8680 Global Sales & Support: 1-800-303-0306 www.natus.com
Natus Europe GmbH Bärmannstrasse 38 D-81245 München Germany
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 One Bio-logic Plaza Mundelein, IL 60060 USA
Global Sales & Support: 1-800-303-0306 Technical Service Fax +1 650-802-8680 E-mail: [email protected] International Support - Please contact your local Distributor Distributor locations can be found at www.natus.com P/N 000976C Rev.D
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 1.6. Upgrade – Version 1.3.0 ...11 2. Routine Maintenance Procedure ...13 2.1. Inspecting Accessory Parts ...13 2.2. Cleaning the ALGO 5...13 2.2.1. Cleaning the Screener ...13 2.2.2. Cleaning the cart ...14 2.3. Safety testing ...14 2.3.1. Ground Integrity ...14 2.3.2. Earth leakage current ...15 2.3.3. Enclosure leakage current ...15 2.4. Performance verification ...16 2.4.1. Equipment Check for the ALGO 5 screener ...16 2.4.2. Component tests ...21 2.4.2.1. General ...21 2.4.2.2. ATA 5 Cable calibration due Warnings ...22 3. Troubleshooting Guide ...23 3.1. Troubleshooting the ALGO 5 ...24 3.2. Troubleshooting the Panel PC ...27 3.2.1. Replacing the battery for the RTC (Real Time Clock) on the Panel PC ...27 3.3. Troubleshooting the Isolation Transformer ...30 3.4. Troubleshooting the ATA 5 ...32 3.5. Troubleshooting the Preamp 5 ...33 3.6. Troubleshooting the PCA 5 ...35 4. Technical Troubleshooting Guide ...36 4.1. High Impedance ...36 4.2. High Myogenic ...37 4.3. High Refer Rate ...38 4.4. High Ambient ...39 5. Parts and Specifications ...40 5.1. How to order parts ...40 5.2. Parts list ...40 5.3. Specifications ...42 6. Index ...43
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 ...16 ALGO® 5 Newborn Hearing Screener Service Manual P/N 000976C RevD
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FIGURE 8: ALGO Check Kit ...16 FIGURE 9: Equipment check ...17 FIGURE 10: DSP Box disconnected ...18 FIGURE 11: Preamp 5 disconnected ...19 FIGURE 12: ATA 5 disconnected ...20 FIGURE 13: Equipment Check - Overview ...21 FIGURE 14: ATA 5 Cable calibration due Warnings ...22 FIGURE 15: Block Diagram wiring ...23 FIGURE 16: Troubleshooting the ALGO 5 ...24 FIGURE 17: Location of Panel PC outer shell screws ...27 FIGURE 18: View outer shell Panel PC ...28 FIGURE 19: Location of Battery on Motherboard Panel PC ...28 FIGURE 20: Detail View RTC Battery on Panel PC ...29 FIGURE 21: Open the power inlet module ...30 FIGURE 22: Access to the fuse holder...30 FIGURE 23: Fuse holder ...31 FIGURE 24: Acoustic Check ...32 FIGURE 25: Impedance Check ...33 FIGURE 26: Artifact Check ...34 FIGURE 27: Impedance Check ...35 FIGURE 28: High Impedance ...36 FIGURE 29: High Myogenic ...37 FIGURE 30: High Refer Rate ...38 FIGURE 31: High Ambient ...39
TABLE 1: Ground Integrity ...15 TABLE 2: Earth leakage current ...15 TABLE 3: Enclosure leakage current ...15 TABLE 4: Parts List for Natus ALGO 5 system ...40
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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) 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 labelled as warning, caution or important. Other explanatory information is highlighted with the word Note. Type of information
WARNING
CAUTION:
Important!
Note:
Usage Identifies conditions or practices that may result in injury or death to the patient and/or user. Warnings are boxed and preceded by a hazard symbol. Precedes an action that may result in damage to or malfunction of the device. An instruction provided to help ensure correct clinical results and provide quality assurance to the screening procedures. Background information provided to clarify a particular step 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 lead to incorrect results.
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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: • • • • •
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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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• • • • • •
1.3.
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)
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
Keyboard
Label Printer Shelf Space Page Printer (optional)
Isolation Transformer
FIGURE 1: ALGO 5 - front view
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Cart Column with Integrated Cable Management – Rear View
DSP Box – Rear View
Preamp Holder Cable management for ATA 5 & PCA 5 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
FIGURE 2: ALGO 5 - rear view (cover removed)
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DSP Serial Number Label on top Panel PC Communication cable
Status LED
Power Socket
Preamp Socket
FIGURE 3: DSP Box
PCA Socket
ATA Socket
Preamp 5 Cable Connector
Hook
FIGURE 4: Preamplifier 5 (Preamp 5)
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Red Transducer: right ear
Blue Transducer: left ear
Connector
FIGURE 5: Acoustic Transducer Assembly (ATA 5)
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 +1 800-303-0306 Technical Service Fax +1 650-802-8680 E-mail: [email protected] International Support: Please contact your local Distributor. Distributor locations can be found at www.natus.com
1.6.
Upgrade – Version 1.3.0 A new version of software was released in mid-2011. Version 1.3.0 implements many improvements to the system. A significant portion of those improvements are in software functionality – improved error handling, better database functionality, improved DSP / PC communication processes, etc., and thus, are not service procedure related. However, there are items that should be appreciated when servicing the system. They are described here. New Pre-Amplifier Module The pre-amplifier module has been improved for better noise-elimination performance. The new module is NOT compatible with previous versions of software. Identification bits in the module EEPROM will alert the system if the wrong module is connected. Additionally, each new module will have an informational label on the preamp body indicating the need to run version 1.3.0 software with the module. “Newer” versus “older” modules can be determined physically by inspection of the module serial number. A “newer” module serial number will be the P6 series – P6XXXXX. An “older” module serial number will be the P5 series – P5XXXXX.
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Electrode Impedance Checks Version 1.3.0 performs periodic impedance checks on the Vertex, Nape, and Common sensors in a manner similar to previous versions of software. This version monitors the difference of impedance values between the Vertex and Nape sensors.
Vertex Impedance minus Nape Impedance ≥ 2 kΩ
System issues a warning message.
Vertex Impedance minus Nape Impedance ≥ 5 kΩ
System pauses and waits for correction.
DSP – PC Communications The communications process between the two subsystems of Algo 5 has been made more error tolerant. Key improvements are: • • • •
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Option to restart the system when the program becomes unresponsive Multiple communications “re-tries” when communications errors between DSP and PC occur Automatic notification to the user that communication errors have been encountered. System can be restarted without the need to “re-boot” the PC.
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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: • • • •
2.1.
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.
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
Turn off power and unplug the screener before cleaning.
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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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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ALGO® 5 Newborn Hearing Screener Service Manual P/N 000976C Rev.D
Using an Ohm Meter, measure impedance between the positive and negative contacts to get a baseline impedance. 3. Using the Ohm Meter, measure the impedance from the ground pin on the outlet plug to any screw on a cart column, such as the bracket that attaches the panel PC to the column. 2.
Subtract the measured value from the baseline value measured in step 2 to get the ground integrity value. Verify that the impedance is less than 100 milliohm (0.1 ohm). 5. Ground integrity should be checked whenever a shelf is adjusted in height. 4.
100 milliohms or less TABLE 1: Ground Integrity
2.3.2. Earth leakage current AC Line cord Neutral cord Polarity Normal Closed Closed Reversed Closed Closed Normal Open Closed Normal Closed Open TABLE 2: Earth leakage current
IEC 60601-1 500 µA 500 µA 1000 µA 1000 µA
UL 60601-1 ANSI/NFPA 99 300 µA 300 µA 500 µA 500 µA
2.3.3. Enclosure leakage current AC line AC line cord AC line cord ground cord neutral conductor polarity conductor Normal Closed Closed Normal Closed Open Normal Open Closed Reversed Closed Open Reversed Open Closed Reversed Closed Open TABLE 3: Enclosure leakage current
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IEC 60601-1
UL 60601-1 ANSI/NFPA 99
100 µA 500 µA 100 µA 500 µA 500 µA 500 µA
300 µA 500 µA 300 µA 500 µA 300 µA 500 µA
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2.4.
Performance verification An equipment check is available using the Main Window of the Panel PC (see FIGURE 7 in Section 2.4.1). If the equipment check option is not available from the main window, access the Service Menu from the Preferences panel to acquire rights via the Profile Manager. 2.4.1. Equipment Check for the ALGO 5 screener Access the Equipment Check from the main window:
FIGURE 7: Main Window Equipment check F5
Use the ALGO Check Kit to run the Equipment Check:
FIGURE 8: ALGO Check Kit
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ALGO® 5 Newborn Hearing Screener Service Manual P/N 000976C Rev.D
The Equipment Check comprises the following routines:
FIGURE 9: Equipment check
o Initialize Baseboard Test DSP board runs a self-test and loads firmware o Cable connection Verifies connectivity of ATA 5 and Preamp 5 o Calibration dates Shows calibration date of ATA 5 (refer to 2.4.2.2 – ATA 5 Cable calibration due ) o Artifact Test Runs internal DSP test program o Acoustic Test Verifies ATA 5 equipment o Impedance Test Verifies electrical properties of PCA 5
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If the DSP Box is not connected to the Panel PC or the DSP Box power cord is disconnected, the Initialize Baseboard Test will fail with the following Warning:
FIGURE 10: DSP Box disconnected
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ALGO® 5 Newborn Hearing Screener Service Manual P/N 000976C Rev.D
If the Preamp 5 is disconnected, the Cable Connection Test shows a red icon with error message below:
FIGURE 11: Preamp 5 disconnected
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If the ATA 5 cable is disconnected, the Cable Connection Test shows a red icon with the error message below:
FIGURE 12: ATA 5 disconnected
If the ATA 5 cable is overdue for calibration, the Calibration Dates section in FIGURE 12 shows a red icon next to the <Next calibration> date. Please refer to chapter 2.4.2.2 – ATA 5 Cable calibration due Warnings):
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ALGO® 5 Newborn Hearing Screener Service Manual P/N 000976C Rev.D
The following figure gives an overview of the hardware components tested during the series of Equipment Check tests.
DSP Box
Equipment Check Kit ATA 5 Cable
Preamp 5
PCA 5 Cable
FIGURE 13: Equipment Check - Overview
The following lists each step in the Equipment Check and identifies which device is involved in the testing: • • • • • •
DSP Box Test – DSP Box and Panel PC Cable Connections – ATA 5 and Preamp 5 Calibration Date – ATA 5 Artifact Test – DSP Box and Preamp 5 Acoustic Test – ATA 5 Impedance Test – PCA 5
2.4.2. Component tests 2.4.2.1.
General
The Service Menu allows performing the following tests in non-screening mode: • • •
Print a test page on Page printer Print a test page on Label printer Scan a Bar code and view result
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