MDD Welch Allyn Hillrom Diagnostic Cardiology Suite... User manual

Welch Allyn®
Diagnostic Cardiology
Suite Spirometry
User Manual

© 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.
CAUTION Federal law restricts this device to sale by or on the order of a
physician.
This document contains confidential information that belongs to Welch Allyn. No part of this document may be
transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written
consent of Welch Allyn. Microsoft and Windows are registered trademarks of Microsoft Corporation. Adobe and
Acrobat are registered trademarks of Adobe Systems Incorporated. DICOM is the registered trademark of the
National Electrical Manufacturers Association for its standards publications relating to digital communications of
medical information. Citrix and Citrix XenApp are registered trademarks of Citrix Systems, Inc. V 2.1.0 2019
Welch Allyn and Connex are registered trademarks of Welch Allyn.
This manual applies to the 901128 CARDIOPULMONARY ECG SYSTEM and the 901051
SPIROMETER.
80023960 Ver. C
Revision date:2019-10
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
welchallyn.com

Contents
Notices ..................................................................................................... 1
User Safety .............................................................................................. 3
Warnings .............................................................................................................. 3
Cautions ............................................................................................................... 6
Note(s) ................................................................................................................. 7
Symbols ................................................................................................... 9
General Care .......................................................................................... 13
Precautions ........................................................................................................ 13
Inspection .......................................................................................................... 13
Cleaning and Disinfecting .................................................................................. 13
Introduction ........................................................................................... 15
Manual Purpose ................................................................................................. 15
Audience ............................................................................................................ 15
Indications for Use ............................................................................................. 15
Contraindications ............................................................................................... 16
System Description ............................................................................... 17
Welcome ............................................................................................................ 17
Product Overview .............................................................................................. 17
Features ............................................................................................................. 19
Important Considerations ................................................................................... 19
Installation ............................................................................................. 21
Spirometry Application Installer ......................................................................... 21
System Installation ............................................................................................ 21
Software Upgrade .............................................................................................. 22
Software Uninstallation ...................................................................................... 22
Spirometer Setup ............................................................................................... 23
Spirometry Display Overview .............................................................. 25
Customizing the Spirometry Module .................................................. 29
Modality Settings and Default Values ................................................. 31
General Tab ........................................................................................................ 31
Viewing Tab ....................................................................................................... 34
Parameters Tab .................................................................................................. 35
iii

Recording Tab .................................................................................................... 37
Customize the spiro.txt File ............................................................................... 37
Ambient Settings ................................................................................... 39
Calibration of Flow Sensor ................................................................... 41
The Calibration Process ..................................................................................... 42
View Calibration Results .................................................................................... 46
Recording Spirometry Tests ................................................................. 51
Start a Test Using the Desktop Application ....................................................... 51
Start a Test from within the EMR ..................................................................... 51
Incentive Screen ................................................................................................ 55
Patient Procedures ............................................................................................. 55
Viewing Spirometry Tests .................................................................... 59
FVC Tab .............................................................................................................. 63
SVC Tab ............................................................................................................. 64
MVV Tab ............................................................................................................ 64
Trend Tab ........................................................................................................... 65
Measurements Tab ............................................................................................ 67
Interpreting Spirometry Tests .............................................................. 69
Complete the Editing Process ........................................................................... 71
Printing Spirometry Reports ................................................................ 73
Configure the Report ......................................................................................... 77
Predictions ............................................................................................. 79
Norm Profiles ..................................................................................................... 79
Norm Extrapolation ............................................................................................ 83
Understanding Interpretation Results ................................................................ 86
Acceptability of an Effort .................................................................................... 86
Maintaining the Spirometer ................................................................. 91
Troubleshooting .................................................................................... 95
Spirometry Errors ............................................................................................... 95
Appendix A : System Specifications .................................................... 99
Spirometry Software Specifications ................................................................... 99
Appendix B: Electromagnetic Compatibility (EMC) .......................... 103
Electromagnetic Compatibility (EMC) .............................................................. 103
Appendix C: Warranty Information .................................................... 109
Your Welch Allyn Warranty .............................................................................. 109
iv Contents Welch Allyn® Diagnostic Cardiology Suite Spirometry

Notices
Manufacturer's Responsibility
Welch Allyn, 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 Welch Allyn, Inc.
• The device is used in accordance with the instructions for use.
Responsibility of the Customer
The user of this device 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
Welch Allyn, Inc. equipment is identified by a serial and reference number on the back of
the device. Care should be taken so that these numbers are not defaced. Software
equipment is accompanied by an identification card; carefully store this card as the
information is needed for activation, upgrade and customer service. This information can
be entered at the time of installation to help ensure the information is not lost.
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 Welch Allyn, Inc.
Other Important Information
The information in this document is subject to change without notice.
Welch Allyn, Inc. makes no warranty of any kind with regard to this material including,
but not limited to, implied warranties of merchantability and fitness for a particular
purpose. Welch Allyn, Inc. assumes no responsibility for any errors or omissions that
may appear in this document. Welch Allyn, Inc. makes no commitment to update or to
keep current the information contained in this document.
1

2Notices Welch Allyn® Diagnostic Cardiology Suite Spirometry

User Safety
WARNING Means there is the possibility of personal injury to you or
others.
CAUTION Means there is the possibility of damage to the device.
Note Provides information to further assist in the use of the device.
This manual may contain screen shots and pictures. Any screen shots and pictures are
provided for reference only. Consult the actual screen in the host language for specific
wording.
Warnings
WARNING This manual gives important information about the use and
safety of this device. Deviating from operating procedures, misuse or
misapplication of the device, or ignoring specifications and
recommendations could result in increased risk of harm to users, patients
and bystanders, or damage to the device.
WARNING The personal computer (non-medical electrical equipment) shall
be situated outside the patient environment (reference IEC 60601-1). The
personal computer used should adhere to the appropriate safety standard
for non-medical electrical equipment (IEC 60950, or its national variants),
and use of an isolation transformer is recommended. The personal
computer used should adhere to the appropriate electromagnetic
compatibility (EMC) standard for non-medical electrical equipment (CISPR
22/24 - FCC Part 15 - CE, or related national variants). If it is required for the
personal computer to be situated within the patient environment, it is the
responsibility of the user to ensure that the system provides a level of
safety in compliance with IEC 60601-1. To ensure the safety of the patient
it must not be possible for the operator to touch the patient and the
computer at the same time. In general, at least 1.5 meters (5’) of open area
must surround the patient to achieve this.
WARNING Device 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.
3

WARNING Users are expected to be licensed clinical professionals
knowledgeable about medical procedures and patient care, and adequately
trained in the use of this device. Before attempting to use this device for
clinical applications, the operator must read and understand the contents of
the user manual and other accompanying documents. Inadequate
knowledge or training could result in increased risk of harm to users,
patients and bystanders, or damage to the device. Contact service for
additional training options.
WARNING To minimize chances of a misdiagnosis, it is the physician’s
responsibility to assure that spirometry tests are properly administered,
evaluated, and interpreted.
WARNING To maintain designed operator and patient safety, peripheral
equipment and accessories used that can come in direct patient contact
must be in compliance with UL 60601-1, IEC 60601-1, and ISO 26782. Only
use parts and accessories supplied with the device and available through
Welch Allyn. Equipment relying only on basic insulation for protection
against electric shock should not be used in the system.
WARNING The device is part of an integral personal computer-based
diagnostic system. The user must adhere to all warnings in order to ensure
safe and reliable performance.
WARNING If operated on AC (~) power, the personal computer must be
connected with its original power cable to an electrical installation that
complies with applicable regulations for environments where patients are
treated.
WARNING If the personal computer is situated within the patient
environment, to maintain designed operator and patient safety when a LAN
network connection is being used, the network cable must be connected
to the device through an Ethernet isolator module that complies with IEC
60601-1-1 (available from Welch Allyn).
WARNING To avoid the possibility of serious injury or death during patient
defibrillation, do not come into contact with device.
WARNING To avoid potential for spread of disease or infection, single-use
disposable components (e.g., flow transducers) must not be reused.
WARNING A possible explosion hazard exists. Do not use the device in
the presence of flammable anesthetic mixture.
WARNING Possible malfunction risks may be present when installing
third-party software. Welch Allyn cannot verify the compatibility of all
possible hardware/software combinations.
WARNING The device has not been designed for use with high-frequency
(HF) surgical equipment and does not provide a protective means against
hazards to the patient.
WARNING The quality of the signal produced by the device may be
adversely affected by the use of other medical equipment, including but
not limited to defibrillation and ultrasound machines.
4User Safety Welch Allyn® Diagnostic Cardiology Suite Spirometry

WARNING Test Welch Allyn Diagnostic Cardiology Suite functions after
each Microsoft critical and security update with a simulator prior to patient
use.
WARNING Damaged or suspected inoperative equipment must be
immediately removed from use and must be checked/repaired by qualified
service personnel prior to continued use.
WARNING To prevent emission of substances that may damage the
environment, dispose of the device, its components and accessories and/or
packing materials that are past the shelf life in accordance with local
regulations.
WARNING Proper functioning backup items such as, display monitor, and
other equipment are recommended on hand to prevent delayed treatment
due to an inoperable device.
WARNING A color printer and a color printout are recommended for
printing spirometry reports. Printing these reports with a monochrome
printer or in black and white can lead to confusion as it is not easy to
identify which curve is a Pre and which is a Post effort.
WARNING Do not perform spirometry test if any of the following
conditions apply to the patient:
• hemoptysis of unknown origin (forced expiratory maneuver may aggravate
the underlying condition);
• pneumothorax;
• unstable cardiovascular status (forced expiratory maneuver may worsen
angina or cause changes in blood pressure) or recent myocardial infarction or
pulmonary embolus;
• thoracic, abdominal, or cerebral aneurysms (danger of rupture due to
increased thoracic pressure);
• recent eye surgery (e.g., cataract);
• presence of an acute disease process that might interfere with test
performance (e.g., nausea, vomiting);
• recent surgery of thorax or abdomen.
WARNING People may become light-headed, dizzy, or even faint during a
spirometry effort. Watch patients closely. If they choose to stand during
testing, keep a chair immediately behind them. If there is any reason for
concern, stop the test and take appropriate action.
WARNING To prevent cross-contamination, do not try to clean the flow
transducers and nose clips. Discard these items after a single patient use.
WARNING The American Thoracic Society (ATS) recommends using
gloves when replacing disposable flow transducers, and washing hands
after touching them.
WARNING No modification of this equipment is allowed.
User manual User Safety 5

WARNING Fire and explosion hazard. Do not operate the spirometer 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 The performance of the spirometer can be affected by the
patient spitting or coughing into the spirometer during expiration.
Cautions
CAUTION Windows compatibility, updates and anti-virus policy: The
Welch Allyn Diagnostic Cardiology Suite software has been fully tested
with Windows 7 (32-bit and 64-bit) Professional Service Pack 1, and
Windows 10 Pro (64-bit) operating systems. The Welch Allyn Diagnostic
Cardiology Suite software has also been tested with Windows Server 2012
R2 and Server 2016. Although it is unlikely that Windows updates and
security patches affect Welch Allyn Diagnostic Cardiology Suite
functionality, Welch Allyn recommends turning automatic Windows update
off, and periodically running it manually. A functional test should be
executed after update, which includes acquiring a recording, editing and
printing a report, as well as importing an order and exporting results, if
activated. Compatibility of Welch Allyn Diagnostic Cardiology Suite with
corporate anti-virus software packages has been evaluated. Welch Allyn
recommends excluding the Welch Allyn Diagnostic Cardiology Suite
database folder (normally C:\ProgramData\MiPgSqlData on a stand-alone
system or the server) from the folders to be scanned. In addition, anti-virus
patch updates and system scans should be scheduled for time periods
when the system is not actively in use or performed manually.
CAUTION No other non-recommended PC application software should be
running while the Welch Allyn Diagnostic Cardiology Suite application is
being used.
CAUTION It is recommended that all workstations and review stations be
periodically updated with Microsoft critical and security updates to protect
from malware attacks and to fix critical Microsoft software issues.
CAUTION To prevent delivery of malware into the system Welch Allyn
recommends that institution operating procedures are written to prevent
malware to be transmitted into the system from removable media.
CAUTION Test information should be backed up to prevent loss of critical
data as a result of a malware attack or system failure.
CAUTION Use only parts and accessories supplied with the device and
available through Welch Allyn . The use of accessories other than those
specified my result in degraded performance of the device.
CAUTION When putting the spirometer away, store the pressure tubing in
a basket or drawer or somewhere that prevents compression or kinking.
CAUTION Avoid installing the spirometer in direct sunlight or in a location
where it may be affected by significant changes in humidity, ventilation, or
airborne particles containing dust, salt or sulfur.
6User Safety Welch Allyn® Diagnostic Cardiology Suite Spirometry

Note(s)
Note Local Administrator permissions are required for software installation, and
application configuration. Local User privileges are required for application
users. Roaming and temporary accounts are not supported.
Note The application times out automatically after 8 hours of inactivity. Any
operation (e.g. Exam Search, Patient Search, editing exams, starting an
exam, etc.) will reset the timeout start time. When returning to the
application after the timeout, the user is prompted to enter login
credentials.
Note When the server is unavailable in a distributed configuration, the client
workstation will notify the user with a prompt to proceed in Offline Mode
or cancel. In Offline Mode, scheduled orders are not available. An exam can
be conducted with manually entered demographics and will be stored
locally. When the server becomes available, the user is prompted with a list
of unsent exams and a selection to send exams to the server database.
Note If not specifically indicated otherwise, personal computer equipment used
with the device can be regarded as:
• Class I (if the computer has a three-prong power inlet) or class II (if it has a
two-prong inlet)
• Ordinary equipment.
• Equipment not suitable for use in the presence of a flammable anesthetic
mixture.
• Continuous operation.
Note To prevent possible damage to the device during transport and storage
(while in original packaging) the following environmental conditions must
be adhered to:
Ambient temperature: -20° C to 60° C (-4° F to 149° F)
Relative humidity: 10% to 95%, non-condensing
Note The compatible spirometer flow sensor, mouthpiece and disposable
accessories are manufactured by Medikro Oy, Finland and Distributed by
Welch Allyn. Medikro’s spirometer accessories are CE marked :
User manual User Safety 7

8User Safety Welch Allyn® Diagnostic Cardiology Suite Spirometry

Symbols
Documentation symbols
WARNING The warning statements in this manual identify conditions or practices that could
lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol
indicates defibrillation protection is in the cables. Warning symbols will appear with a grey
background in a black and white document.
CAUTION The caution statements in this manual identify conditions or practices that could
result in damage to the equipment or other property, or loss of data.
Miscellaneous symbols
Manufacturer Do not dispose as unsorted
municipal waste. Requires
separate handling for waste
disposal according to local
requirements.
Consult 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.
Not made with natural rubber latex
USB Single Use - Do Not Reuse
Protected against the ingress of
solid foreign objects ≥12.5 mm
diameter, not protected against the
ingress of water.
Serial Number
Reorder Number Batch Code
Model Identifier Global Trade Item Number
9

Expiration Date To identify a type BF applied part
complying with IEC 60601-1.
Meets essential requirements of
the European Medical Device
Directive 93/42/EC
-Applies to spirometer hardware
Canadian Standards Association
mark of conformity
By prescription or order of
physician or dentist
Note Refer to the manual(s) accompanying the device that pertain to the
computer hardware for additional definitions of symbols that may be
present.
10 Symbols Welch Allyn® Diagnostic Cardiology Suite Spirometry

Package Symbol Delineation
Fragile
Keep dry
Keep away from heat / sunlight
Temperature limit
Atmospheric pressure limitation
Humidity limitation
User manual Symbols 11

12 Symbols Welch Allyn® Diagnostic Cardiology Suite Spirometry

General Care
Precautions
• Turn off the device before inspecting or cleaning.
• Do not immerse the device in water.
• Do not use organic solvents, ammonia based solutions, alcohol, or abrasive cleaning
agents which may damage equipment surfaces.
Inspection
Inspect your equipment daily prior to operation. If you notice anything that requires
repair, contact an authorized service person to make the repairs.
•Verify that all cords and connectors are securely seated.
• Check the case and chassis for any visible damage.
• Inspect cords and connectors for any visible damage.
• Inspect keys and controls for proper function and appearance.
Cleaning and Disinfecting
Note To clean the PC or any PC accessories, consult the manufacturer’s
recommendation for cleaning procedures.
WARNING Use of unspecified cleaning/disinfecting agents or failure to
follow recommended procedures could result in increased risk of harm to
users, patients and bystanders, or damage to the device.
CAUTION Do not clean the pressure tubing or sensor. Trapped moisture
could affect their accuracy. Replace the pressure tubing if it becomes
visibly soiled, is known to be contaminated with blood or sputum, or after
100 uses, whichever comes first. After replacing the used pressure tube,
discard it. Replace the sensor when it becomes faulty.
CAUTION You cannot clean the spirometer or any of its components.
13

CAUTION If you choose to clean the calibrations syringe, clean the outer
surface of the syringe with only the following solutions or wipes:
• Solution of dish soap and water, ½ tsp per cup of water
• Solution of bleach and water, 1 part bleach (6% sodium hypochlorite) with 9
parts water
• Isopropyl alcohol and water, 70% by volume
• PDI Sani-Cloth Plus wipes (14.85% Isopropanol)
• Cavi-Wipes (17.2% Isopropanol)
CAUTION Keep the spirometer away from splashing fluids.
14 General Care Welch Allyn® Diagnostic Cardiology Suite Spirometry

Introduction
Manual Purpose
This manual provides information about the Welch Allyn Diagnostic Cardiology Suite
Spirometry software:
• Installing Welch Allyn Diagnostic Cardiology Suite Spirometry
• Spirometry Display Overview
• Customizing the Spirometry Module
• Ambient Settings
• Calibration of the Flow Sensor
• Recording Spirometry Tests
• Viewing Spirometry Tests
• Interpreting Spirometry Tests
• Printing Spirometry Reports
• Prediction Norms
• Maintaining the Spirometer
This manual supplements the Welch Allyn Diagnostic Cardiology Suite Manager manual.
For information on the shared components of the Manager and the Spirometry
applications — for example, searching for patient data, setting system wide settings —
see the Welch Allyn Diagnostic Cardiology Suite Manager manual .
Note This manual contains screen images that are for illustration, and might be
different in the actual product. Consult the actual screen in the host
language for specific wording.
Audience
This manual is written for clinical professionals with a working knowledge of medical
procedures and terminology as required for monitoring cardiac patients.
Indications for Use
The Welch Allyn Diagnostic Cardiology Suite is a prescription device intended for use by
physicians, other licensed health care practitioners, and trained personnel who are acting
on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use
in medical clinics, physician offices and hospital settings to acquire, analyze, display,
15

transmit and print certain physiological signals identified below and provide the data for
consideration by a physician.
Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead
diagnostic resting ECG and diagnostic spirometry applications and is designed to operate
within the inherent capabilities of an off-the-shelf laptop or PC Windows operating
system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to
patient data management including communication with electronic medical records
systems. Welch Allyn Diagnostic Cardiology Suite Resting ECGs are intended to be
taken with the patient in the supine position and offer VERITAS™ resting ECG algorithm
to generate measurements and advisory statements for review and interpretation by the
physician.
Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological
vital signs monitor, not intended to be used in a mobile medical environment (e.g.
ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters,
nor in conjunction with high frequency surgical equipment.
Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function
testing, providing forced expiratory flow-volume and time measurements. The device is
intended to be a general assessment tool assisting the clinician in the diagnosis of
pulmonary function. These devices are commonly used on patients with occupational
exposure to dust or chemicals; presenting with symptoms such as chronic cough,
shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis,
asthma, and COPD; or other patients where the clinician determines these pulmonary
function measurements are needed.
Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for adult and pediatric
patients age 6 years and older and should only be used with patients able to understand
the instructions for performing the test.
Contraindications
Contraindications to performing spirometry are:
•Hemoptysis of unknown origin (forced expiratory maneuver may aggravate the
underlying condition);
• Pneumothorax;
• Unstable cardiovascular status (forced expiratory maneuver may worsen angina or
cause changes in blood pressure) or recent myocardial infarction or pulmonary
embolus; thoracic, abdominal, or cerebral aneurysms (danger of rupture due to
increased thoracic pressure);
• Recent eye surgery (e.g., cataract);
• Presence of an acute disease process that might interfere with test performance
(e.g., nausea, vomiting);
• Recent surgery of thorax or abdomen.
16 Introduction Welch Allyn® Diagnostic Cardiology Suite Spirometry