Welch Allyn H-Scribe Service Manual, 9516-147-50-ENGLITPDF Lab-Line Bench Top Incubated Shaker OPERATION AND REPAIR MANUAL AND PARTS LIST Model Numbers 3527 3527-1 35271 3527-1CE 3527-5 35275
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be
transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of
Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. H-SCRIBE and H12+ are
trademarks of Mortara Instrument, Inc.
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Technical Support and Service
Headquarters Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel: 414.354.1600
Tel: 800.231.7437
Fax: 414-354-4760
Internet: http://www.mortara.com
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
Tel: 414.354.1600
Fax : 414.354.4760
E-mail: sales@mortara.com
European Economic
Community Representative
Mortara Rangoni Europe, Srl
(European Headquarters, Italy)
Via Cimarosa 103/105
40033 Casalecchio di Reno (BO)
Tel: +39.051.298.7811
Fax: +39.051.613.3582
7865 North 86th Street
Milwaukee, WI 53224
Tel: 414.354.1600
Service: 888-MORTARA
(888.667.8272)
Fax : 414.354.4760
E-mail: techsupport@mortara.com
24 Hour Technical Support
Same Day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts
.
Mortara Instrument, B.V.
(The Netherlands)
H. Dunantplein 6
3731 CL De Bilt
Postbus 131
3720 AC Bilthoven
Tel: +31.30.2205050
Fax: +31.30.2213525
Mortara Instrument Australia P/L
Unit 11, 7 Inglewood Place
(PO Box 7568)
Baulkham Hills NSW 2153
Tel: +61.2.8824 5499
Fax: +61.2.8814 5399
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Notices
Manufacturer’s Responsibility
Mortara Instrument, Inc., is responsible for the effects on safety and performance only if
•Assembly operations, extensions, readjustments, modifications or repairs are carried out only by persons
authorized by Mortara Instrument, Inc.
•The device (H-Scribe) is used in accordance with the instructions for use.
Responsibility of the Customer
The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to
do so may cause undue failure and possible health hazards.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by serial and part numbers on the side, back or bottom of the device. Care
should be taken so that these numbers are not defaced.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part of this document may
be photocopied, reproduced or translated to another language without prior written consent of Mortara Instrument, Inc.
Other Important Information
The information in this document is subject to change without notice.
Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied
warranties of merchant ability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for
any errors or omissions that may appear in this document. Mortara Instrument Inc. makes no commitment to update or to
keep current the information contained in this document.
Warning: The H-Scribe System offers network capabilities and more than one system can be installed on the same
network to exchange patient data and Final Reports. Remote sites share drives, and there is no login or password required
to run the H-Scribe software. A higher level of security, however, can be achieved through an existing local network with a
security policy already in place. It is the responsibility of the local network administrator to connect an H-Scribe System to
a network and to assign users’ login names and passwords.
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Warranty Information
Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products
(hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and
maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara.
The warranty period is defined as twelve (12) months following the date of shipment from Mortara. Normal use, service and
maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This
Warranty does not apply to damage to the Products caused by any or all of the following circumstances or conditions:
a) Freight damage;
b) Parts and/or accessories of the Products not obtained from or approved by Mortara;
c) Misapplication, misuse, abuse and failure to follow the Product instruction sheets and/or information guides;
d) Accident, a disaster affecting the Products;
e) Alterations or modifications to the Products not authorized by Mortara;
f) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT
CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCTS FOUND UPON EXAMINATION BY MORTARA
TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects
promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further
be conditioned upon the assumption by the purchaser of the Products (i) of all carrier charges with respect to any Products
returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or
representative of Mortara, and (ii) all risk of loss in transit. It is ex pressly agreed that the liability of Mortara is limited and
that Mortara does not function as an insurer. A purchaser of a Product, by its acceptance and purchase thereof,
acknowledges and agrees that Mortara is not liable for loss, harm or damage due directly or indirectly to an occurrence or
consequence therefrom relating to the Products. If Mortara should be found liable to anyone under any theory (except the
expressed warranty set forth herein) for loss, harm or damage, the liability of Mortara shall be limited to the lesser of the
actual loss, harm or damage, or the original purchase price of the Product when sold.
EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS
PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES AND MAGNETIC STORAGE MEDIUMS.
EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A
PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE
PRODUCTS FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE
REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCTS TO THE EXTENT THAT THE DEFECT IS NOTICED
AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM
FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL OR CONSEQUENTIAL
DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE OR EXPENSE OF ANY KIND, INCLUDING LOSS OF
PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR
OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANT ABILITY AND THE
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
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User Safety Information
Means there is the possibility of personal injury to you or
Warning
Caution
Note
Federal law restricts this device for sale to and use by or on the order of a physician.
Warning
•Device (Holter System) captures and presents data reflecting a patient’s physiological condition that when
reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should
not be used as a sole means for determining a patient’s diagnosis.
•To ensure that electrical safety is maintained during operation from AC ~ power, the device must be plugged into a
Hospital Grade outlet.
•To maintain operator and patient safety, peripheral equipment and accessories used that can come in direct patient
contact must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25.
•To maintain operator and patient safety, only use parts and accessories supplied with the device and available
through Mortara Instrument, Inc.
• If a possible explosion hazard exists, do not use the device in the presence of flammable anesthetics.
• Before attempting to use the device for clinical applications, the operator must read and understand the contents of
the operator’s manual and any documents accompanying the device.
others.
Means there is the possibility of damage to the equipment.
Provides information to further assist in the use of the device.
Caution
• Do not attempt to clean the device or patient cables by submerging into a liquid, autoclaving or steam cleaning.
• Wipe the exterior surface of the device with an alcohol-free sterilizing disinfectant, avoiding aggressive detergents;
then dry with a clean cloth.
•The internal battery is a lithium type and is maintenance free. If the battery appears to become defective, contact
Mortara Instrument, Inc. Technical Support Group.
•A Final Report that includes the Summary, Profile, Trends and 5 pages of strips (including 3 pages of 12-lead
strips and one 6-minute strip page) in PDF format is approximately 1,760 KB in size. Final reports that are saved
to the local hard drive will cause the system to fill over a period of time. These files will need to be removed from
the hard drive prior to causing the system to cease to operate. Periodic checks of the H-Scribe System capacity are
recommended. Contact Mortara Instrument, Inc. Technical Support Group for assistance with removal of these
files.
•System environment:
Operating temperature: +10° to +35° C
Storage temperature: -40° to +65° C
Relative humidity: 8% to 80%
Altitude: -50 to 10,000 ft
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Notes
•Poor patient preparation prior to electrode attachment may affect the recording and could interfere with the
operation of the device.
•The H12+ Digital Recorder High Fidelity data requires a special version of H-Scribe software to export the 1,000
samples per second waveforms. If you have standard H-Scribe software on your analysis system, you will not
benefit from the acquisition of this High Fidelity data.
•An ambulatory 12-lead ECG obtained with torso-located limb electrodes is not equivalent to a conventional
diagnostic ECG.
Equipment Symbols
Symbol Delineation
Attention, consult accompanying documents
CE Mark
Do not dispose as unsorted municipal waste. Per EC
Directive 2002/96, requires separate handling for waste
disposal according to national requirements
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Table of Contents
1 General Information
General Information...............................................................................................................1.1
The purpose of this manual is to supply information to service personnel so they can maintain the H-Scribe System,
information for peripheral devices should be found in manuals supplied with equipment or by contacting original
manufacturer. This manual is intended to function primarily as a guide to preventative and corrective maintenance
and electrical repairs considered field repairable.
User Safety Information
Periodic Safety Inspections
Follow the recommended maintenance schedule. Inspect the power cord and transmission cables periodically for
fraying or other damage and replace as needed. Broken or frayed wires may cause interference or loss of signal.
Pay particular attention to points where wires enter connectors.
Do Not Operate in Explosive Atmospheres
Do not operate the H-Scribe in the presence of flammable gasses or anesthetics, this environment could cause an
explosion. Refer to User's Manual Safety Information: Warning(s) and Caution(s).
Do Not Mount Product above Patient
Do not mount or place any part of the product where it could fall on a patient or where it could be accidentally
knocked off a shelf or other mounting arrangement.
Recommended Accessories
For the patient's safety and optimum equipment performance, use only the accessories specified by Mortara
Instrument, Inc.
Sterilizing this Product
Do not sterilize this product or any accessories unless specifically directed by the manufacturer. Sterilization and
sterilization environments can seriously damage many components and accessories.
Liquid Spills
Do not set beverages or other liquids on or near the H-Scribe, and/or optional equipment.
Clean and inspect system
PC Performance check 1 Yr. Use of standard Windows utilities sufficient
6 mo. More frequent cleaning may be required in
unusually dusty or dirty environments.
PC Performance Check
WARNING
•Check the hard disk space to verify the system is not nearing capacity; this could have an adverse affect on
overall system performance (see below).
•Also check the Programs menu for any 3
maintenance check.
Additional third party software installed on any Mortara PC based system may affect the
integrity of the system. Mortara is not responsible for issues resulting from the use or
installation of additional software by non-Mortara personnel.
rd
party software that may have been installed since the last
This section contains instructions for periodic cleaning and inspection of the instrument as preventive maintenance
measures
WARNING
Ventilate work area thoroughly when using solvents. Observe manufacturers warnings on
solvent containers with regard to personnel safety and emergency first aid. Be sure that first
aid equipment is available before using chemicals. Observe shop safety and fire
precautions. Ventilate all work areas where solvents are used. Store solvents and so lventsoaked rags in approved containers. Refer to manufacturers’ instructions on containers for
recommended fire-fighting procedures, and make sure that fire-fighting equipment is
available.
Exterior Cleaning
CAUTION
Use a damp, clean cloth to wipe off external surfaces and the line cord. Do not use solvents, or cleaning solutions
that may damage the surface of the instrument. Alcohol or naphtha will not damage the unit's exterior. Avoid
contact with open vents, plugs, and jacks. Naphtha removes sticker residue.
Unplug from power outlet before cleaning. Do not wipe over surfaces of nameplates or
labels with abrasive cleaners or materials, as this will eventually wear away the nameplate
information. Do not use solvents to clean plastic parts.
Interior Cleaning
•Vacuum any dust or debris that may have collected in the PC housing, paying special attention to air ventilation
passages and air cooling fans.
• Brush all surfaces and parts with a non-metallic, soft bristle brush.
• Wipe metal surfaces with soft, non-abrasive cloth dampened with isopropyl alcohol.
•The printed circuit board assemblies in the H-Scribe system contain static sensitive devices. Use special
handling procedures to prevent damage due to ESD.
•Clean assembled parts with a vacuum cleaner or low pressure compressed air (30 psi). Take care when cleaning
printed circuit boards that wires or component leads are not bent back and forth in such a manner as to weaken
them and cause them to eventually break.
•Dry with low pressure compressed air.
Monitor Cleaning
WARNING
Unplug the monitor from the power outlet before cleaning.
•To clean your monitor screen, lightly dampen a soft, clean cloth with water or mild detergent. If possible, use a
special screen cleaning tissue or solution suitable for the anti-static coating.
•To clean the monitor cabinet, use a cloth lightly dampened with mild detergent. Make sure that water can not
drip into the case of the monitor.
•Wipe off stubborn stains from the cabinet or screen with a cloth lightly dampened in alcohol (methyl, ethyl or
isopropyl). Do not use benzene, thinner, ammonia, or abrasive cleaners.
To avoid risk of electric shock and damage to the monitor, do not disassemble the monitor
cabinet. The unit is not user-serviceable. User maintenance is restricted to the following
cleaning instructions.
Compact Flash Card Reader Cleaning
WARNING
•Use “Electronic safe non-residue solvent” to carefully spray the connector pins to remove any residue, dust or
debris that may have collected.
Safety glasses should be worn when using spray solvents to prevent the possibility of eye
injuries.
The H-Scribe System is a high-speed, PC-based Holter scanner. Designed in conjunction with the H3+ Digital
Holter recorder, the H12+ Digital Holter recorder and the X12+ ambulatory transmitter data received by the
Surveyor Central patient monitoring system, the H-Scribe System provides three channels of full disclosure data for
arrhythmia analysis and 12-Lead ST segment analysis depending on the recorder type used. The H-Scribe System
incorporates Mortara Instrument’s exclusive VERITAS™ algorithm for superior beat detection and analysis.
The H-Scribe System is offered in two versions.
•The H-Scribe Clinic Holter System is designed for institutions that need a centralized system for
acquisition of H3+ 2-channel or 3-channel Holter data, review, editing, final report generation and
archiving. This is the central system on the network and allows acquisition of H3+ recorded Holter data,
review, editing, final report generation and archiving. This model allows the institution to take advantage
of advanced scanning options, Final Report export, the network and multiple Patient List capabilities.
•The H-Scribe Enterprise Holter System is designed for large institutions and users that desire to take
advantage of advanced acquisition options (Holter data uploaded to a web server and Surveyor Central 12Lead telemetry patient monitoring data), the network and multiple Patient List capabilities. This is the
central system on the network and allows downloading of H3+ and/or H12+ recorded Holter data, review,
editing, final report generation, final report export and archiving.
The H-Scribe Remote Download Station is designed for users that need a system for acquisition of Holter data and
final report review. This configuration does not allow review and editing of the Holter data and requires network
connection to an H-Scribe Enterprise or Clinic system. This configuration offers the ability to acqu ire reco rdings
from both H3+ and H12+ recorders with the Enterprise System or H3+ with the Clinic System. This model also
supports multiple Patient List and network capability.
The H-Scribe Review Station is designed for users that need review, editing, final report generation and archiving
capabilities. This configuration does not allow acquisition of patient recordings and requires network connection to
an Enterprise or Clinic system.
The H12+ Digital Holter Recorder records 12-lead ECG continuously for a 24-hour period using a 24-hour
Compact Flash card. The H12+ 48 Hour Digital Holter Recorder records 12-lead ECG continuously for up to 48
hours with the 48-Hour Compact Flash card.
The H3+ Digital Holter Recorder records two or three channels of continuous ECG data over a 24-hour or 48-hour
period. Stored ECG data is downloaded for analysis to the H-Scribe System with a USB interface cable after the
H3+ patient cable has been disconnected from the recorder. After the data is acquired at the H-Scribe System, the
H3+ recorder memory is cleared and the recorder can be prepared for the next recording session using the H-Scribe
application software.
The Surveyor Telemetry Central System at software version 3.00 and later receives 12-lead ECG data from the
X12+ ambulatory transmitter. The full disclosure monitoring data is imported into the H-Scribe system through the
use of the H-Scribe Surveyor Import application. Any Surveyor Central patient monitoring period up to 48 hours in
duration can be chosen for Holter analysis.
24 and 48 hour Holter recordings can optionally be uploaded to an institution web server with the H-Scribe Web
Option software component integrated into the web service from a remote client computer over the internet. The HScribe system will then connect to and acquire the recordings from the web server for full Holter analysis.
Report formats include scan criteria, report summary, rhythm profile, 24-hour trends of all arrhythmias and ST
segment changes, operator-selected strips in one, two, and three or twelve leads and full disclosure of three
channels.
The user may customize the scanning criteria that are used to analyze a patient record. Most changes, with a few
exceptions, are instantly applied to the current analysis which eliminates the time spent on rescanning. Scan criteria
are saved on a per-patient basis and affect the current patient’s analysis only, unless the user desires to modify the
user preferences or scan criteria for future analyses.
Multiple recordings with analyses are stored on the hard drive o f the H-Scribe System in patient slots. The user can
select a patient slot to store a new recording or to review existing analyses.
Long term storage of full disclosure patient recordings is accomplished by archiving data to DVD-RW or CD-RW
media as well as a local or network drive. Archived patient recordings can be restored to the H-Scribe system for
further analysis, review, report export or printing at any time.
H-Scribe System with CF Card Reader and Optional Cassette Reader
H-Scribe System Specifications
CPU:
Operating System:
Storage:
Input devices:
Monitor:
Printing Device:
Operating Environment:
Pentium class tower
Windows
Hard drive, DVD+/-RW or CD-RW disc, any arbitrary drive
H3+ USB interface cable, Compact Flash card reader; extended
keyboard and 2-button mouse with wheel; 3.5” floppy disk drive,
DVD+RW/CD-RW drive, Cassette reader (optional)
Color monitor
High speed laser printer
Operating temperature: +10° to +35° C
Storage temperature: -40° to +65° C
Relative humidity: 8% to 80%
Altitude: -50 to 10,000 ft
Power Requirements:
3-2
100 - 240 VAC at 50/60 Hz
800 watts maximum, 400 watts average
be rotating when
the PC in operating; if the fans are not rotating, or they appear to be
running at less than optimal speed, the fans should either be
cleaned or replaced prior to continued operation.
The PC parts identified above (with the exception of the cooling fans) are considered “Field Replaceable” and can
be purchased through Mortara, if desired (refer to the item listing for Mortara part numbers).
stored patient
data, custom settings, and additional software or data that was
loaded on the system. The PC will be restored to the exact state it
was in, when delivered from Mortara Instrument.
The System Restoration option should only be used on a system that is experiencing serious
performance issues, or if the system is to be reassigned to a new facility or departmental area.
CAUTION
Before performing system restoration, make sure you have properly
identified the PC model number. The PC has an identification
sticker indicating the model. If you have any questions regarding
the identification, contact Mortara Service for assistance.
HP Model 7700 restoration process:
• Turn the system on and then press the F11 key when instructed to do so. After some
time, the PC Recovery Wizard will appear.
• Make sure the option “Recover the PC to a specific point in time” is selected and then
click on Next.
• Under Description, click on “Initial Recovery Point” (or the most recent recovery point
installed by the manufacturer) and then click on Next.
• In the Smart PC Recovery screen, select the option “Recover PC without preserving new
and updated files” and then click on Next.
• Click on Yes to begin the Recovery Process. The drive will first be formatted; then the
Recovery Point will be copied.
• Once the Recovery Process is complete, click on Restart. The system will then reboot.
Log back into the system, and then click on Yes to restart the system. Log back into the
system.
Items to check prior to contacting Mortara Customer Service Center
o Check power connections
o Is the PC fan turning?
o Are there any LEDs (lights) on the front panel of the PC?
o Does the display show anything at all?
o Is Windows starting to load?
o Does Windows finish loading and bring up the desktop?
o Are there any error messages
• H-Scribe application will not run
o Is software dongle installed?
o Dong le Failure?
o Check windows explorer to verify system sees card.
o Attempt to access card. If you are unable to access card it is likely a hardware problem with the
flashcard. (contact Technical Support)
•Application can not acquire data from card
o Verify flashcard has data files via Windows Explorer
o Verify flashcard has correct Volume Label Mortara_H12