Hillrom Mortara Welch Allyn Diagnostic Cardiology... User manual

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Service Manual
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Service Manual
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Copyright
© Copyright 2019, Welch Allyn. All rights are reserved. To support the intended use of the product
described in this publication, the purchaser of the product is permitted to copy this publication, for internal
distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of
this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn
assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that
may result from failure to use this product in accordance with the instructions, cautions, warnings, or
statement of intended use published in this manual.
Unauthorized copying of this publication may not only infringe copyright but also reduce the ability of
Welch Allyn to provide accurate and up-to-date information to users and operators alike.
Welch Allyn Diagnostic Cardiology Suite®, AM12®, WELCH ALLYN WIRELESS ACQUISITION
MODULE®, and ELI®are trademarks of Welch Allyn.
Software in this product is Copyright 2019, Welch Allyn. All rights are reserved. The software is protected
by United States of America copyright laws and international treaty provisions applicable worldwide.
Under such laws, the licensee is entitled to use the copy of the software provided on the original
distribution medium. The software may not be copied, decompiled, reverse-engineered, disassembled or
otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the
software; all right, title and ownership of the software remains with Welch Allyn.
The information contained in this manual is subject to change without notice.
All changes will be in compliance with regulations governing manufacture of medical equipment.
80024495 Ver. A
Revision Date: 2019-08
901128 CARDIOPULMONARY ECG SYSTEM
EU IMPORTER
Welch Allyn Limited
Navan Business Park, Dublin Road,
Navan, Co. Meath C15 AW22
Ireland
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY
13153 USA
www.welchallyn.com

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Service Manual
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User responsibility
This product is designed to perform in conformity with the description thereof contained in this manual
and accompanying labels and inserts, when assembled, operated, maintained and repaired in
accordance with the instructions provided. A defective product should not be used. Parts that are broken,
plainly worn, missing or incomplete, distorted or contaminated should be replaced immediately. Should
any repair or replacement become necessary, we recommend that service be performed at the nearest
approved service center. The user of the product shall have the sole responsibility for any malfunction,
which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone
other than Welch Allyn or their authorized service personnel.
Accessories
The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories and
replacement parts.
Caution
Use of accessories other than those recommended by Welch Allyn may
compromise product performance.
Caution
US Federal law restricts this device to sale by or on the
order of a physician.

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Warranty, Service, and Spare Parts
Warranty
All repairs on products under warranty must be performed or approved by Welch Allyn. Unauthorized
repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall
exclusively be performed by Welch Allyn certified service personnel.
Assistance and Parts
If the product fails to function properly or if assistance, service, or spare parts are required please contact
the nearest Welch Allyn Technical Support Center:
www.welchallyn.com/en/other/contact-us
Before contacting Welch Allyn, it is helpful to attempt to duplicate the problem and to check all
accessories to ensure that they are not the cause of the problem.
When calling, please be prepared to provide:
Product name and model number and complete description of the problem
The serial number of your product (if applicable)
The complete name, address and phone number of your facility
For out-of-warranty repairs or spare parts orders, a purchase order (or credit card) number
For parts order, the required spare or replacement part number(s)
Repairs
If your product requires warranty, extended warranty, or non-warranty repair service, please call first the
nearest Welch Allyn Technical Support Center. A representative will assist you troubleshooting the
problem and will make every effort to solve it over the phone, avoiding potential unnecessary return.
In case the return cannot be avoided, the representative will record all necessary information and will
provide a Return Material Authorization (RMA) number, as well as the appropriate return address. A
Return Material Authorization (RMA) number must be obtained prior to any return.
Note
Welch Allyn does not accept returned products without an RMA.
Packing Instructions
If you have to return goods for service, follow these recommended packing instructions:
Remove all hoses, cables, sensors, power cords, and ancillary products (as appropriate) before
packing, unless you suspect they are associated with the problem.
Wherever possible use the original shipping carton and packing materials.
Include a packing list and the Welch Allyn Return Material Authorization (RMA) number.
It is recommended that all returned goods be insured. Claims for loss or damage to the product must be
initiated by the sender.

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Limited Warranty Statement
Hillrom, Inc. warrants that the Welch Allyn Diagnostic Cardiology Suite computer-based product you have
purchased meets the labeled specifications of the Product and will be free from defects in materials and
workmanship that occur within 1 year after the date of purchase. Accessories used with the Product are
warranted for 90 days after the date of purchase.
The date of purchase is: 1) the date specified in our records, if you purchased the Product directly from
us, 2) the date specified in the warranty registration card that we ask you to send to us, or 3) if you don’t
return the warranty registration card, 120 days after the date on which the Product was sold to the dealer
from whom you bought the Product, as documented in our records.
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or maintenance
contrary to labeled instructions, 3) alteration or repair by anyone not authorized by Welch Allyn, and 4)
accidents.
You assume all responsibility for use of the Product with any hardware or software that does not meet the
system requirements described in the Product documentation.
If a Product or accessory covered by this warranty is determined to be defective because of defective
materials, components, or workmanship, and the warranty claim is made within the warranty period
described above, Welch Allyn will, at its discretion, repair or replace the defective Product or accessory
free of charge.
You must obtain a return authorization from Welch Allyn to return your Product before you send it to
Welch Allyn’s designated service center for repair.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE. WELCH ALLYN'S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO
REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT
RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A
PRODUCT DEFECT COVERED BY THE WARRANTY.

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Table of contents
1Safety Summary.....................................................................................................7
1.1 Introduction..........................................................................................................7
1.2 Symbols...............................................................................................................8
1.3 Servicing the Welch Allyn equipment safely........................................................9
1.3.1 General Warnings .........................................................................................9
1.3.2 General Cautions ........................................................................................12
2Purpose and Scope..............................................................................................13
2.1 Service Options.................................................................................................13
2.1.1 Warranty Service.........................................................................................13
2.1.2 Technical Support Services.........................................................................13
2.1.3 Returning products......................................................................................14
2.2 Recommended Service Intervals.......................................................................14
2.2.1 Recommended Service Intervals Resting ECG...........................................14
2.2.2 Recommended Service Intervals Spirometry ..............................................14
3Database Maintenance ........................................................................................16
3.1 Moving PCs and/or Moving the Welch Allyn Diagnostic Cardiology Suite
Database...................................................................................................................16
4Functional Verification Overview........................................................................17
4.1 Functional Verification ECG Recorder...............................................................17
4.1.1 Equipment required.....................................................................................17
4.1.2 Patient Cable Verification............................................................................18
4.1.3 Computer Interface Verification...................................................................18
4.1.4 Resting ECG Results Verification................................................................19
4.1.5 Cleaning the AM12/Welch Allyn Wireless Acquisition Module ECG Recorder
19
4.2 Functional verification Spirometer.....................................................................20
4.2.1 Maintenance Welch Allyn Diagnostic Cardiology Suite Spirometer.............20
4.2.2 Cleaning the Welch Allyn Diagnostic Cardiology Suite Spirometer.............21
5Troubleshooting the Welch Allyn Diagnostic Cardiology Suite family of
devices.........................................................................................................................22
5.1 Problem-Solving suggestions Welch Allyn Diagnostic Cardiology Suite
AM12/Welch Allyn Wireless Acquisition Module Cardiographs .................................22
5.2 Problem-Solving suggestions Welch Allyn Diagnostic Cardiology Suite
Spirometer.................................................................................................................23
6Technical Support................................................................................................24
7ECG Checklist and Test Results Form...............................................................25

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1 Safety Summary
1.1 Introduction
This manual is written for Biomedical or IT engineers to support maintenance of the Welch Allyn
Diagnostic Cardiology Suite family of devices.
We at Welch Allyn are dedicated to providing safe products to our customers. It is the user’s responsibility
to follow the established rules of safety as described in this manual for their protection and for the
protection of their patients.
The hospital's Biomedical/IT support staff shall require primary skills including disciplines related to
maintenance and servicing computer controls/platforms.
Please take note of all safety precautions and warnings provided with the devices before using
the devices and the accompanying software.
Warnings
Power strips (multiple portable socket outlets) are not allowed for use in
connecting the medical electrical equipment or any accessories to ground unless
used in concert with a medical approved isolation transformer.
Accessible metal parts, such as electrode terminations, should not come in
contact with other electrically conductive parts, including earth ground.
Welch Allyn provides a number of high quality patient leads in varying termination
styles. Use of these approved patient leads is required for electrical protection of
the patient during cardiac defibrillation.
Welch Allyn Diagnostic Cardiology Suite devices are not intended for direct
cardiac application.
If there is a requirement for equipment to be connected to a personal computer or
other non-medical rated equipment, it is the responsibility of the user to ensure
that the electric power circuit to which the Welch Allyn Diagnostic Cardiology
Suite system is connected includes an additional protective earth ground or an
isolation transformer in order to satisfy the IEC 60601-1 safety standard.
Other medical equipment—including but not limited to defibrillators, ultrasound
machines, pacemakers, and other stimulators—may be used simultaneously with
the electrocardiograph. However, such devices may disturb the
electrocardiograph signal.
No modification of this equipment is allowed.

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1.2 Symbols
Documentation symbols
WARNING
Indicated conditions or practices that, if continued or not corrected immediately,
could lead to illness, injury, or death.
Caution
Indicated conditions or practices that, if continued or not corrected immediately,
could damage the equipment.
Single Use - Do Not Reuse
Protected against the ingress of solid foreign objects ≥ 12.5 mm diameter, not
protected against the ingress of water.
Shipping, storing, and environment symbols
YYYY-MM
Expiration Date
Keep away from sunlight
Stacking limits
Fragile
Keep away from rain
Equipment symbols
Serial Number
Product Identifier
Defibrillation-Proof Type CF applied part
Manufacture Date
YYYY-MM-DD
Temperature Range
Reorder Number

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Do not dispose of in trash, for devices
Consult operating instructions/directions for use (DFU). A copy of the DFU is
available on this website. A printed copy of the DFU can be ordered from Welch
Allyn for delivery within 7 calendar days.
Global Trade Item Number
1.3 Servicing the Welch Allyn equipment safely
Before using or servicing the Welch Allyn equipment, you must read and understand the following safety-
related information.
1.3.1 General Warnings
The following warning statements apply to the Welch Allyn Diagnostic Cardiology Suite family of devices
in general. Warning statements that apply specifically to particular procedures or devices you can find in
the corresponding Welch Allyn Diagnostic Cardiology Suite user manuals / device manuals:
Resting ECG manual
AM12 manual
Welch Allyn Wireless Acquisition Module manual
Spirometry manual
WARNINGS Related to the environment
WARNING: To avoid a possible explosion, do not use the Welch Allyn Diagnostic
Cardiology Suite family of devices in the presence of flammable anesthetics.
WARNING: Do not use the Welch Allyn Diagnostic Cardiology Suite family of
devices in an MRI suite or hyperbaric chamber.
WARNING: Do not autoclave the Welch Allyn Diagnostic Cardiology Suite family of
devices or cables.
WARNINGS Related to Accessories and other equipment
WARNING: For operator and patient safety, peripheral equipment and accessories
that can come in direct patient contact must be in compliance with all appropriate
safety, EMC, and regulatory requirements. For detailed information on this
requirement we refer to the “Guidance and the manufacturer’s declaration” of the
user and device manuals.
WARNING: The Welch Allyn Diagnostic Cardiology Suite family of devices has not
been designed for use with high-frequency (HF) surgical equipment and does not
protect against hazards to the patient.
WARNINGS Related to using the Welch Allyn Diagnostic Cardiology Suite
family of devices
WARNING: Satisfactory maintenance procedures must be implemented, or
equipment failure and health hazards may result.
WARNING: Avoid positioning any leads or cables so that they could easily trip
someone.
WARNINGS Related to repairing the Welch Allyn Diagnostic Cardiology Suite
family of devices

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WARNING: Only qualified service personnel should attempt to repair the device. In
case of malfunction, call Technical Support and precisely describe the problem. For
contact information, see page 3.
WARNING: While under warranty, the device must be serviced only by a Welch
Allyn service technician.
WARNING: Electrostatic discharge (ESD) can damage or destroy electronic
components. Handle static-sensitive components only at static safety workstation.
WARNING: Consider all electrical and electronic components of the monitor as
static-sensitive
WARNINGS Related to the Welch Allyn Diagnostic Cardiology
Suite ECG recorders
WARNING: As with any electronic equipment, Radio Frequency (RF) interference
between the cardiograph and any existing RF transmitting or receiving equipment at
the installation site, including electro surgical equipment, should be evaluated before
the equipment is operated. Pay special attention to electro surgical equipment and
other RF transmitters that are in close proximity to the cardiograph as they are
sources of RF interference as they may seriously degrade performance. Like all
electronic devices, this cardiograph is susceptible to electrostatic discharge (ESD).
Electrostatic discharge typically occurs when electrostatic energy is transferred to
the patient, the electrodes, or the cardiograph. ESD may result in ECG artifact that
may appear as narrow spikes on the cardiograph display or on the printed report.
When ESD occurs, the cardiograph’s ECG interpretation may be inconsistent with
the physician’s interpretation.
Welch Allyn assumes no liability for failures resulting from RF interference between
Welch Allyn medical electronics and any radio frequency generating equipment
when these levels exceed those established by applicable standards.
WARNING: During defibrillation, the ECG signals displayed may show waveform
artifacts and cannot be relied on as a true indication of the patient’s physical
condition.
WARNING: An inoperable or damaged electrocardiograph can be identified by
abnormal signals on the ECG waveforms. Abnormal signals are characterized by
flat lines, excess noise, square waves or other non-typical anomalies that appear on
the ECG waveform. The electrocardiograph can be periodically tested by
connecting the Welch Allyn Diagnostic Cardiology Suite AM12/Welch Allyn Wireless
Acquisition Module to an ECG simulator. Follow manufacturer’s instructions.
WARNING: The electrocardiograph has not been designed for use with high
frequency (HF) surgical equipment and does not protect against hazards to the
patient.
WARNING: Fire and explosion hazard. Do not operate the electrocardiograph in the
presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in
oxygen-enriched environments; or in any other potentially explosive environment.
WARNING: To prevent the spread of infection, take these precautions:
•Dispose of single-use components (for example, electrodes) after using
them once.
•Regularly clean all components that come in contact with patients.
•Consult your facility's equipment cleaning procedures when performing ECG
testing on patients with open, infectious sores.

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WARNINGS Patient and operational safety notes
WARNING: Your cardiograph isolates all connections to the patient from electrical
ground and all other conductive circuits in the cardiograph. This reduces the
possibility of hazardous currents passing from the cardiograph through the patient’s
heart to ground. To ensure the patient’s safety and your own please observe the
following:
When operating your Welch Allyn System from AC power, be sure it and all other
electrical equipment connected to or near the patient are effectively grounded.
Use only grounded power cords (three-wire power cords with grounded plugs). Also
make sure the outlet accepts the plug and is grounded. Never adapt a grounded
plug to fit an ungrounded outlet by removing the ground prong or ground clip. The
patient cable should be routed away from power cords and any other electrical
equipment. Failure to do so can result in AC power line frequency interference on
the ECG trace.
The Welch Allyn warranty can only be honored if you use Welch Allyn approved
accessories and replacement parts. See Maintaining the Cardiograph for more
information.

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1.3.2 General Cautions
The following caution statements apply to the Welch Allyn Diagnostic Cardiology Suite family of devices
in general. Caution statements that apply specifically to particular procedures or devices you can find in
the corresponding Welch Allyn Diagnostic Cardiology Suite user manuals / device manuals:
Resting ECG manual
AM12 manual
Welch Allyn Wireless Acquisition Module manual
Spirometry manual
Caution statements indicate conditions or practices that could damage the equipment or other property.
General Cautions
Caution: Use of accessories other than those recommended by Welch Allyn may
compromise product performance.
Caution: When removing the device from storage, allow it to thermally stabilize to the
surrounding environmental conditions before using it.
Caution: To prevent possible damage to the device, do not use sharp or hard objects to
press keys. Only use fingertips.
Caution: Do not pull or stretch the cables. Doing so could result in mechanical or electrical
failures. Form cables into a loose loop before storing.
Caution: Portable and mobile RF communications can affect the performance of the
device.
Cautions Related to the Welch Allyn Diagnostic Cardiology Suite ECG recorders
Caution: Radio Frequency (RF) interference between the AM12/Welch Allyn Wireless
Acquisition Module ECG Recorder or cardiograph and any existing RF transmitting or
receiving equipment at the installation site, including electrosurgical equipment, in close
proximity to the cardiograph should be evaluated before the equipment is operated as they
may seriously degrade performance.
Caution: The Welch Allyn Diagnostic Cardiology Suite Cardiograph is susceptible to
interference from RF energy sources (lowered RF immunity) which exceed the IEC 60601-
1-2 limits, such as power line bursts, other medical devices, cellular products, information
technology equipment and radio/television transmission.
Caution: To reduce EMC interference the cardiograph shall be separated from the emitting
source as much as possible. If assistance is needed, call your local Welch Allyn service
representative.
Caution: Artifact on the ECG caused by electromagnetic interference should be evaluated
by a physician or physician authorized personnel to determine if it will negatively impact
patient diagnosis or treatment.
Caution: Like all electronic devices, this cardiograph is susceptible to electrostatic
discharge (ESD). Electrostatic discharge typically occurs when electrostatic energy is
transferred to the patient, the electrodes, or the cardiograph. ESD may result in ECG
artifact that may appear as narrow spikes on the cardiograph display or on the printed
report. When ESD occurs, the cardiograph’s ECG interpretation may be inconsistent with
the physician’s interpretation.
Caution: Welch Allyn assumes no liability for failures resulting from RF interference
between Welch Allyn medical electronics and any radio frequency generating equipment
when these levels exceed those established by applicable standards.
Caution: The patient cable is intended to be inserted and removed from the AM12/Welch
Allyn Wireless Acquisition Module ECG Recorder in a push / pull motion. Do not twist the
cable. Damage to the cables and the AM12 ECG Recorder will occur.

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2 Purpose and Scope
The service manual is a reference for periodic preventive maintenance and corrective service procedures
and custom configurations.
Corrective service is supported to the level of field-replaceable parts.
Note
Opening and repair of the Welch Allyn Diagnostic Cardiology Suite
family of devices can only be performed by certified and qualified
service personnel at an authorized Welch Allyn Service center.
Caution
No component-level repair of circuit boards and subassemblies is
supported. Use only the repair procedures described in the manual.
Warning
When performing a service procedure, follow the instructions exactly
as presented in this manual. Failure to do so could damage the
equipment, invalidate the product warranty, and lead to serious
personal injury.
This guide provides troubleshooting, installation and configuring information and instructions for functional
testing and performance verification.
2.1 Service Options
2.1.1 Warranty Service
All repairs on products under warranty must be performed and/or approved by Welch Allyn. Refer all
warranty service to Welch Allyn Factory Service or another authorized Welch Allyn Service Center. Obtain
an RMA number for all returns to Welch Allyn Factory Service –see Returning Products.
Caution
Unauthorized repairs will void the product warranty.
Non-Warranty Service
Welch Allyn Factory Service and authorized Service Centers support non-warranty repairs. Contact any
Welch Allyn regional service center for pricing and service options.
Welch Allyn offers modular repair parts for sale to support non-warranty service. This service must be
performed only by qualified end-user biomedical/clinical engineers using this service / installation manual.
2.1.2 Technical Support Services
Welch Allyn offers the following technical support services:
Telephone support
Loaner equipment
Service Agreements
Replacement service parts
Factory service
For information on any of these services, contact Welch Allyn as detailed on page 3.

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2.1.3 Returning products
To return a product for service, contact Welch Allyn Technical Support and request a Return Material
Authorization (RMA) number.
Note
Welch Allyn does not accept returned products without an RMA.
When requesting an RMA, please have the following information available:
Product name, model number and serial number.
A complete return shipping address, including a contact name and phone number; include any
special shipping instructions.
A purchase-order number or credit card number if the product is not covered by warranty.
A full description of the problem or service request.
To ship the unit, please observe these packing guidelines:
Remove from the package all hoses, connectors, cables, sensors, power cords and other
ancillary products and equipment, except those items that might be associated with the problem.
Use the original shipping carton and packing materials, or as close an approximation as possible.
Include a packing list.
Write the Welch Allyn RMA number with the Welch Allyn address on the outside of the shipping
carton.
2.2 Recommended Service Intervals
2.2.1 Recommended Service Intervals Resting ECG
Interval or Condition
Action Recommended
Procedure
Every 6-24 months (per hospital
procedure)
Complete Functional test
Functional verification ECG recorder
Unit has been dropped or otherwise
damaged
Complete Functional test
Functional verification ECG recorder
Unit malfunctioning
Complete Functional test
Functional verification ECG recorder
Unit does not pass Functional verification
Troubleshooting and repair followed
by functional test
Troubleshooting ECG recorder
Troubleshooting Software module
Functional verification ECG recorder
Return to Authorized service center
Returning products
2.2.2 Recommended Service Intervals Spirometry
The Spirometer sensor needs little maintenance to stay in good working condition. Change the flow
transducer for each patient. Check daily for damages. Check that all connections are properly aligned and
tight. Visually check the pressure tubing for leaks and kinks. Check for irreversible bending or
compression of the pressure tubing between flow transducers and device.
Ensure Spirometer is calibrated, and that the proper calibration code is used. The calibration code can be
found on the Labeling that came with your flow transducer package. For proper installation, refer to the
Calibration chapter in the Welch Allyn Diagnostic Cardiology Suite Spiro manual. Replace sensor when
faulty.
Avoid placing the Spirometer and any of its components in direct sunlight or in a dusty environment.

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CAUTION
To make reliable recordings, calibrate the sensor on a daily basis.
Keep track of the calibrations in the calibration log.
Interval or Condition
Action Recommended
Procedure
Unit has been dropped or
otherwise damaged
Recalibrate
Calibration procedure Welch Allyn Diagnostic
Cardiology Suite Spiro manual
Unit malfunctioning
Recalibrate
Calibration procedure Welch Allyn Diagnostic
Cardiology Suite Spiro manual
Unit does not pass
calibration
Troubleshooting and repair followed by
functional test
Troubleshooting Spirometer
Return to Authorized service center
Returning products
Every 90 days, or 200
maneuvers, or detected
signs of wear / damage,
whichever comes first
Replace Pressure-Tubing
Welch Allyn Diagnostic Cardiology Suite Spirometry
manual

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3 Database Maintenance
3.1 Moving PCs and/or Moving the Welch Allyn Diagnostic
Cardiology Suite Database
When switching from the PC on which Welch Allyn Diagnostic Cardiology Suite was originally installed to a
new PC, if the user wants to keep the data stored locally, it is necessary to move the database from the
previous PC to the new PC. Moving the database would also be required if large architecture changes are
required for the system, such as changing the system from a standalone system to an advanced or EMR-
integrated system while keeping old exam data. The following process details how to move the database
from the original PC with Welch Allyn Diagnostic Cardiology Suite installed to the new PC with a new
Welch Allyn Diagnostic Cardiology Suite version installed:
Starting with the original PC, the database can be located by following
C:\ProgramData\MiPgSqlData. The
MiPgSqlData folder contains the FDrepo
folder and pgdata folder which together
represent the database.
Since Welch Allyn Diagnostic Cardiology
Suite is installed on the original PC, the
two database folders are currently being
used by the CorScribeDBSvc service. To
modify these two database folders, the
CorScribeDBSvc service must be stopped. To do this
go to Control Panel\ System and
Security\Administrative Tools\ and select Services. Or
press Ctrl+Alt+Delete, start the Task Manager, go to
the Services tab and in the bottom right click the
Services… button.
Once in the services window find CorScribeDBSvc
and select Stop. Stopping this service will also cause
the services CorScribeAppServer and
CorScribeLogServer to stop.
Now that these services are stopped the user can
move the database folders out of the original PC’s
MiPgSqlData folder to a flash drive or external hard drive until the user is ready to put them in
the location of the new PC’s database.
Once the new PC has the Welch Allyn Diagnostic Cardiology Suite installed, new FDrepo and pgdata
folders are created in C:\ProgramData\MiPgSqlData. The user must delete these folders to move the
original database into the MiPgSqlData folder. To delete these folders the CorScribeDBSvc service must
again be stopped as before. Once the folders are deleted the user is then able to move the original
database from the external drive to the MiPgSqlData folder. The user can then start the services
CorScribeDBSvc, CorScribeAppServer and CorScribeLogServer.
At this point the new PC is running and accessing the data that was moved from the original PC.

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4 Functional Verification Overview
This section describes the procedure for a complete functional test to support recommended preventive-
maintenance schedules.
Functional verification does not require opening the device case.
Whenever the device is serviced, or problems are suspected, Welch Allyn recommends a Functional
Check.
WARNING Only qualified service personnel should perform a full functional
verification procedure.
4.1 Functional Verification ECG Recorder
A checklist of the functional tests is provided on Checklist and Test Results Form I. It is recommended
that you print a copy of the checklist each time you perform the functional verification procedure, so you
can record and save the test results. If the ECG recorder ever requires service, the records of test results
often facilitate troubleshooting.
4.1.1 Equipment required
Commercially Available General-purpose/Medical Test Equipment
Item
Description
ECG simulator
Standard 12 lead ECG simulator
Computer
Welch Allyn Diagnostic Cardiology Suite software version 2.1.0 or higher, with appropriate
modules, installed
DVM
Digital Volt Meter

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4.1.2 Patient Cable Verification
1. The Patient cable should be inspected for any cracks, exposed wires or other damage
2. The impedance of each cable needs to be individually measured, between contact 1 and the banana
clip at the opposite end of the cable. Anywhere in the range of 9 Kto 11 Kis acceptable.
Cable
Expected
impedance
(Ohm)
AHA
EUR
10 K(+/- 10%)
LA
L
RA
R
LL
F
V1
C1
V2
C2
V3
C3
V4
C4
V5
C5
V6
C6
RL
N
4.1.3 Computer Interface Verification
The interface between the computer and the ECG recorder depends on the type of recorder and the
connection used on the computer. In the following table you find all possible configurations.
Recorder type
Part number
Computer
connection
Part number
AM12
9293-048-64
USB
N/A (incorporated)
WELCH ALLYN WIRELESS ACQUISITION
MODULE
30012-019-75
(UTK)
30012-021-60
The AM12 cable should be inspected for any cracks, exposed wires or other damage.
Follow this procedure to verify that the ECG recorder, in combination with the computer interface,
is working:
1.Connect the patient cable to the ECG simulator
2.Set the ECG simulator on a specific simulation for example 90 BPM
3.Connect the patient cable to the ECG recorder
4.AM12: Connect the Computer Interface cable to the computer and the ECG recorder
WELCH ALLYN WIRELESS ACQUISITION MODULE: Pair the ECG recorder with the
computer using the UTK
5.Start the Welch Allyn Diagnostic Cardiology Suite Software
6.Create a new test patient or select a previously created test patient¹.
7.Start a Resting ECG and follow the instructions on the screen².
8.You should see the ECG traces on the computer screen³
9.Monitor the ECG traces for approximately one minute³
10. Record a Resting ECG²
If the complete procedure passes with no issues, the communication is working properly.
¹ See the Welch Allyn Diagnostic Cardiology Suite user’s manual for further detail
²See the Welch Allyn Diagnostic Cardiology Suite Resting ECG user’s manual for further detail
³ Resolve issues/problems with the use of the troubleshooting guide

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4.1.4 Resting ECG Results Verification
To verify the ECG results you can perform the following procedure:
a. Select the ECG on the screen which you recorded.
b. Manually measure the following parameters and compare them with the computer
measurements. You can fill in the test results on Checklist and Test Results Form I.
Heart rate ± 1BPM
Height Calibration pulse
4.1.5 Cleaning the AM12/Welch Allyn Wireless Acquisition Module ECG
Recorder
For information about cleaning the AM12 or Welch Allyn Wireless Acquisition Module ECG Recorder
please refer to the appropriate manual.

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4.2 Functional verification Spirometer
Functional verification can be performed by using the Calibration procedure described in the Welch Allyn
Diagnostic Cardiology Suite Spiro manual.
4.2.1 Maintenance Welch Allyn Diagnostic Cardiology Suite Spirometer
The Spirometer sensor needs little maintenance to stay in good working condition. Change the flow
transducer for each patient. Check daily for damages. Check that all connections are properly aligned and
tight. Visually check the pressure tubing for leaks and kinks. Check for irreversible bending or
compression of the pressure tubing between flow transducers and device.
To ensure that the Spirometer is calibrated properly, confirm that the proper flow-tube lot number and
calibration code are used. The flow-tube lot number and calibration code can be found on the wrapper of
each individually wrapped flow-tube. For proper installation, refer to chapter 7 of the Welch Allyn
Diagnostic Cardiology Suite Spiro manual. Replace sensor when faulty.
Avoid placing Spirometer and any of its components in direct sunlight or in a dusty environment.
CAUTION
To make reliable recordings, calibrate the sensor on a daily basis.
Keep track of the calibrations in the calibration log.