REF 9515-218-50-ENG Rev A1
Connex®
Cardio
12-LEAD ELECTROCARDIOGRAPH SYSTEM
USER MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Copyright © 2017
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
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. AM12, WAM,
and ELI are trademarks of Mortara Instrument, Inc. SCF (Source Consistency Filter) is a copyright of Mortara
Instrument, Inc. 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. V1.0.0 2017-10
TABLE OF CONTENTS
1. GENERAL STATEMENTS ................................................................................................................ 1 TECHNICAL SUPPORT AND SERVICE ..................................................................................................................................... 1 2. NOTICES ........................................................................................................................................... 2 MANUFACTURER’S RESPONSIBILITY .................................................................................................................................... 2 RESPONSIBILITY OF THE CUSTOMER .................................................................................................................................... 2 EQUIPMENT IDENTIFICATION ............................................................................................................................................. 2 COPYRIGHT AND TRADEMARK NOTICES ............................................................................................................................... 2 OTHER IMPORTANT INFORMATION ..................................................................................................................................... 2 3. WARRANTY INFORMATION ............................................................................................................ 3 YOUR MORTARA WARRANTY ............................................................................................................................................ 3 4. USER SAFETY INFORMATION........................................................................................................ 5 WARNINGS.................................................................................................................................................................... 5 29. FCC COMPLIANCE STATEMENT FOR THE WAM ........................................................................................................ 7 CAUTIONS ..................................................................................................................................................................... 8 NOTES .......................................................................................................................................................................... 9 5. EQUIPMENT SYMBOLS AND MARKINGS ................................................................................... 11 SYMBOL DELINEATION ................................................................................................................................................... 11 PACKAGE SYMBOL DELINEATION ...................................................................................................................................... 12 6. GENERAL CARE............................................................................................................................. 13 PRECAUTIONS .............................................................................................................................................................. 13 INSPECTION ................................................................................................................................................................. 13 CLEANING AND DISINFECTING ......................................................................................................................................... 13 4. ELECTROMAGNETIC COMPATIBILITY (EMC) ............................................................................ 15 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS .................................................................. 16 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ................................................................... 16 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ................................................................... 17 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT
................................................................................................................................................................................. 18 5. INTRODUCTION .............................................................................................................................. 19 MANUAL PURPOSE ....................................................................................................................................................... 19 AUDIENCE ................................................................................................................................................................... 19 INTENDED USE ............................................................................................................................................................. 19 INDICATIONS FOR USE ................................................................................................................................................... 20 SYSTEM DESCRIPTION .................................................................................................................................................... 20 ACQUISITION MODULE TYPES ......................................................................................................................................... 21 WAM with Lead Wires ............................................................................................................................................. 21 USB Transceiver Key (UTK) ....................................................................................................................................... 21 WAM LED Indicators ................................................................................................................................................ 22 AM12 with Lead Wires ............................................................................................................................................. 22 LEAD FAIL ................................................................................................................................................................... 22 CONNEX CARDIO SOFTWARE INSTALLATION PROCESS .......................................................................................................... 23 DICOM FEATURE ACTIVATION ....................................................................................................................................... 34 CONNEX CARDIO LOGIN AND MAIN DISPLAY ...................................................................................................................... 35 i
TABLE OF CONTENTS
CONNEX CARDIO PROGRAM ICONS AND DESCRIPTIONS ........................................................................................................ 36 USER ROLES AND PERMISSIONS ....................................................................................................................................... 37 CONNEX CARDIO WORKSTATION SPECIFICATIONS ............................................................................................................... 38 WAM SPECIFICATIONS .................................................................................................................................................. 40 WAM AND AM12 ACCESSORIES .................................................................................................................................... 41 Acquisition Modules................................................................................................................................................. 41 Manuals ................................................................................................................................................................... 41 CONNEX CARDIO NETWORK OPERATION IN A DISTRIBUTED CONFIGURATION ........................................................................... 42 Microsoft Updates ................................................................................................................................................... 42 Anti‐Virus Software .................................................................................................................................................. 43 Encrypt Protected Health Information (PHI) Stored in Connex Cardio ..................................................................... 43 6. USING CONNEX CARDIO .............................................................................................................. 45 Schedule an exam .................................................................................................................................................... 45 Start a resting exam ................................................................................................................................................ 45 Acquiring a STAT ECG exam ..................................................................................................................................... 45 Reviewing and signing an exam and printing a report ............................................................................................ 45 REAL‐TIME DISPLAY ...................................................................................................................................................... 45 RECORDING AN ECG ..................................................................................................................................................... 47 PREVIEW ACQUISITION SCREEN ............................................................................................................................. 47 Timed ECG Capture .................................................................................................................................................. 48 ECG Capture from the Full Disclosure Data Window ............................................................................................... 48 ECG COLLECTION USING THE ACQUISITION MODULE .......................................................................................... 49 CONNECTING THE ACQUISITION MODULE .............................................................................................................. 49 PAIRING WAM WITH CONNEX CARDIO .................................................................................................................. 49 7. MWL/PATIENTS .............................................................................................................................. 51 MWL ........................................................................................................................................................................ 51 EDIT ORDER ................................................................................................................................................................ 51 NEW ORDER ................................................................................................................................................................ 52 DELETE AN EXISTING ORDER ........................................................................................................................................... 52 EXIT MWL/PATIENTS ................................................................................................................................................... 52 Patients ............................................................................................................................................................... 53 Edit Patient ....................................................................................................................................................... 53 New Patient ...................................................................................................................................................... 53 Delete Patient .................................................................................................................................................. 53 Exit MWL/Patient ............................................................................................................................................ 53 8. RECORD AN ECG ........................................................................................................................... 55 PATIENT PREPARATION .................................................................................................................................................. 55 Preparing Patient Skin ............................................................................................................................................. 55 PATIENT HOOKUP ......................................................................................................................................................... 55 To Attach the Electrodes .......................................................................................................................................... 55 Patient Hookup Summary Table .............................................................................................................................. 57 PATIENT DEMOGRAPHIC ENTRY ....................................................................................................................................... 58 STAT ECG .................................................................................................................................................................. 58 START A RESTING EXAM ................................................................................................................................................. 58 Scheduled Order(s) ................................................................................................................................................... 58 No Scheduled Order(s) ............................................................................................................................................. 59 ECG ACQUISITION, PRINTING, AND STORAGE .................................................................................................................... 60 DISPLAY OVERVIEW....................................................................................................................................................... 60 ii
TABLE OF CONTENTS
Menu Selections ....................................................................................................................................................... 60 Date/Time ................................................................................................................................................................ 60 Real‐Time Heart Rate ............................................................................................................................................... 60 Timed Capture Status .............................................................................................................................................. 61 Full Disclosure ECG ................................................................................................................................................... 61 ECG Display Menu Icons .......................................................................................................................................... 61 ACQUIRE ECGS ............................................................................................................................................................ 62 Manual ECG Capture ............................................................................................................................................... 62 Best 10 Seconds Selection ........................................................................................................................................ 62 Capturing ECGs from Full Disclosure ........................................................................................................................ 63 Timed ECG Recording ............................................................................................................................................... 63 Captured ECG Display and Icons .............................................................................................................................. 63 Printing .................................................................................................................................................................... 65 Storage .................................................................................................................................................................... 65 Change Settings ....................................................................................................................................................... 65 9. CONTEXT MENUS .......................................................................................................................... 67 CONTEXT MENU SETTINGS ............................................................................................................................................. 67 Change Lead Format ................................................................................................................................................ 67 3 + 1 Lead Format – Select Lead .............................................................................................................................. 67 3 + 3 Lead Format – Select Leads ............................................................................................................................. 68 Full Disclosure Change Lead Format ........................................................................................................................ 68 Full Disclosure Single‐lead Format – Change Lead .................................................................................................. 68 Full Disclosure Three‐lead Format – Change Leads ................................................................................................. 68 Full Disclosure Change Print Lead ............................................................................................................................ 68 Change the ECG Presentation Gain.......................................................................................................................... 68 Change the ECG Presentation Speed ....................................................................................................................... 68 Change ECG Low Pass Filter ..................................................................................................................................... 69 Apply Anti‐Aliasing to the ECG Display .................................................................................................................... 69 Change AC Filter on the Real‐time ECG.................................................................................................................... 69 Change ECG Presentation To or From Cabrera Format ........................................................................................... 70 Change Median Zoomed Lead in ECG Review Mode ............................................................................................... 70 Switch Between Best Ten and Last 10 Seconds Capture in Real‐Time ECG Mode ................................................... 70 Print Pace Spike Channel ......................................................................................................................................... 70 Display and Print Average RR Interval ..................................................................................................................... 70 Display and Print QTcB (Bazett) ............................................................................................................................... 70 Display and Print QTcF (Fridericia) ........................................................................................................................... 71 Print Automatic Interpretation Text ........................................................................................................................ 71 Display and Print Automatic Interpretation Reasons Text ....................................................................................... 71 Display Calipers for on‐screen measurement .......................................................................................................... 71 10. EXAM SEARCH ............................................................................................................................... 73 SELECTING ECG REPORTS TO REVIEW ............................................................................................................................... 73 ................................................................................................................................................................................. 73 ADVANCED SEARCH....................................................................................................................................................... 74 Exam State Identifiers .............................................................................................................................................. 75 Exam Criteria Identifiers .......................................................................................................................................... 75 EDIT A RESTING ECG REPORT ......................................................................................................................................... 76 Editing Interpretation .............................................................................................................................................. 76 Editing Measurements ............................................................................................................................................. 77 Settings .................................................................................................................................................................... 77 Measurement caliper tool ....................................................................................................................................... 78 iii
TABLE OF CONTENTS
Editing Patient Information ..................................................................................................................................... 78 Printing the Report .................................................................................................................................................. 78 Complete the Editing process .................................................................................................................................. 78 REPORT PRINT PREVIEW ................................................................................................................................................ 79 ICON TOOL BAR ........................................................................................................................................................... 79 SECTIONS .................................................................................................................................................................... 79 Exit the Print Preview ............................................................................................................................................... 79 3. SYSTEM SETTINGS........................................................................................................................ 81 MANAGE USER ACCOUNTS AND PERSONNEL ...................................................................................................................... 81 User’s Database ....................................................................................................................................................... 81 Personnel ................................................................................................................................................................. 81 NEW USER .................................................................................................................................................................. 82 MANAGE/CREATE GROUPS ............................................................................................................................................ 82 MODALITY SETTINGS ..................................................................................................................................................... 83 WAVEFORMS TAB ......................................................................................................................................................... 84 Waveforms .............................................................................................................................................................. 84 Median Zoom ........................................................................................................................................................... 85 ACQUIRE TAB............................................................................................................................................................... 86 Main ......................................................................................................................................................................... 86 Real Time ................................................................................................................................................................. 86 FULL DISCLOSURE TAB ................................................................................................................................................... 87 RESTING ECG TAB ........................................................................................................................................................ 89 CFD CONFIGURATION ................................................................................................................................................... 91 ELI LINK CONFIGURATION .............................................................................................................................................. 92 Item .......................................................................................................................................................................... 93 Description ............................................................................................................................................................... 93 Host Name or IP ....................................................................................................................................................... 93 Entry field for the network name or IP address of the networked ELI Link service .................................................. 93 Port Number ............................................................................................................................................................ 93 Entry field for the TCP port number for network communication with the ELI Link service .................................... 93 Site Number ............................................................................................................................................................. 93 Entry of a number will uniquely identify the Connex Cardio that is communicating with the ELI Link service ........ 93 Encryption Key ......................................................................................................................................................... 93 Entry field for use of a secret string shared between the ELI Link service and the Connex Cardio .......................... 93 UNLOCK EXAMS ........................................................................................................................................................... 93 MANAGE ARCHIVE STORAGE .......................................................................................................................................... 93 Add Archive Location ............................................................................................................................................... 93 Recover Archived Exams .......................................................................................................................................... 95 AUDIT TRAIL LOGS ........................................................................................................................................................ 96 ................................................................................................................................................................................. 96 SERVICE LOGS .............................................................................................................................................................. 96 CONFIGURE WORKFLOW ................................................................................................................................................ 97 Workflow Config ...................................................................................................................................................... 97 No Legal Signature ................................................................................................................................................... 98 About the Legal Signature ....................................................................................................................................... 98 USER PREFERENCES ....................................................................................................................................................... 98 CONNEX CARDIO WILL PRESENT THE DEFAULT SETTINGS ON ANY OF THE WORKSTATIONS THAT THE USER LOGS
INTO. ........................................................................................................................................................................ 98 REPORT CONFIGURATION TOOL ....................................................................................................................................... 99 USER ROLE ASSIGNMENT TABLE .................................................................................................................................... 100 iv
1. GENERAL STATEMENTS
Technical Support and Service
Headquarters
Mortara Instrument
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel:
414.354.1600
Tel:
800.231.7437
Fax:
414.354.4760
Internet: http://www.mortara.com
Sales Support/
Supplies & Accessories
Mortara Instrument
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel:
414.354.1600
Fax:
414.354.4760
Hospital Customers:
Physician Practice:
U.S. Distribution:
orders.us@mortara.com
orderspc.us@mortara.com
orderspc.us@mortara.com
European Union
Representative
Service/Technical
Support Group
Mortara Instrument Europe s.r.l.
(European Headquarters)
Via Cimarosa 103/105
40033 Casalecchio di Reno (BO)
Italia
Tel:
+39.051.298.7811
Fax:
+39.051.613.3582
Mortara Instrument
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel:
414.354.1600
Service: 888.MORTARA
(888.667.8272)
Fax:
414.501.7977
E-mail:
techsupport@mortara.com
1
2. 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 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
Mortara Instrument, 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.
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 merchantability 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.
2
3. WARRANTY INFORMATION
Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara
products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the
number of years specified on documentation accompanying the product, or previously agreed to by the purchaser
and Mortara, or if not otherwise noted, for a period of thirteen (13) months from the date of shipment.
Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted
to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date
of first use, whichever is sooner.
Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE
HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE
MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for
a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of the following
circumstances or conditions:
a)
Freight damage;
b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara;
c)
Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information
guides;
d) Accident; a disaster affecting the Product/s;
e)
Alterations and/or modifications to the Product/s 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 PRODUCT/S 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 Product/s (i) of all
carrier charges with respect to any Product/s 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 expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A
purchaser of a Product/s, 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 there from relating to the
Product/s. 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/s when sold.
3
WARRANTY INFORMATION
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
PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE
THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S 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 MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE.
4
4. USER SAFETY INFORMATION
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.
NOTE: 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
1.
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.
2.
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.
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.
4.
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 IEC 60601-2-25. Only use
parts and accessories supplied with the device and available through Mortara Instrument
5.
Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each lead for
defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.
6.
Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including
the neutral conductor of the patient cable and electrodes, should not come into contact with other conductive
parts including earth ground.
7.
Do not attempt to clean the patient cables by submersing into a liquid, autoclaving, or steam cleaning as this
may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild
detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents, failure to
follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to
users, patients and bystanders, or damage to the device.
8.
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.
9.
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.
10. The personal computer used and any peripheral devices connected to it must be approved to the appropriate
safety standard for nonmedical information technology equipment per IEC 60950, or its national variants. The
5
USER SAFETY INFORMATION
personal computer and any peripheral devices connected to it, being non-medical electrical equipment, must be
situated outside the patient environment per IEC 60601-1–1. 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.
11. If the personal computer is situated within the patient environment, ensure that its level of safety is that of
medical electrical equipment per IEC 60601-1. This may be accomplished by powering the computer and any
other equipment connected to it through an isolation transformer or by operating on battery power.
12. 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 Mortara Instrument).
13. ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
Electrode materials and ingredients are specified on the packaging or are available from the vendor upon
request.
14. To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with
device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is
required to minimize harm to the patient.
15. Proper clinical procedure must be employed to prep the electrode sites and to monitor the patient for excessive
skin irritation, inflammation, or other adverse reactions. Electrodes are intended for short-term use and should
be removed from the patient promptly following testing. Do not mix electrodes made of dissimilar metals.
16. To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must
not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
17. A possible explosion hazard exists. Do not use the device in the presence of flammable anesthetic mixture.
18. Possible malfunction risks may be present when installing third-party software. Mortara Instrument. cannot
verify the compatibility of all possible hardware/software combinations.
19. 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.
20. When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be
met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike
amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.
21. 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.
22. Use only recommended alkaline battery cells with WAM™. Use of other cells may present a risk of fire or
explosion.
23. The WAM low battery warning function is designed for alkaline battery cells only. Use of other cells may
result in failure of the low battery warning possibly resulting in a malfunction of the device.
24. Test Connex Cardio functions after each Microsoft critical and security update with a simulator prior to patient
use.
25. Damaged or suspected inoperative equipment must be immediately removed from use and must be
checked/repaired by qualified service personnel prior to continued use.
6
USER SAFETY INFORMATION
26. To prevent emission of substances that may damage the environment, dispose of the device, its components and
accessories (e.g., batteries, cables, electrodes), and/or packing materials that are past the shelf life in accordance
with local regulations.
27. When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),
and/or packing materials in accordance with local regulations.
28. Proper functioning backup items such as a spare patient cable, display monitor, and other equipment are
recommended on hand to prevent delayed treatment due to an inoperable device.
29.
FCC Compliance Statement for the WAM
In the United States use of this device is regulated by the Federal Communications Commission (FCC). The WAM
with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled exposure.
FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the device.
WAM FCC ID: HJR-WAM2500
UTK FCC ID: HJR-UTK2500
These devices comply with Part 15 of the FCC rules. Operation is subject to the following conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause undesired
operation.
7
USER SAFETY INFORMATION
Cautions
1.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables
should be stored after forming them into a loose loop.
2.
Proper functioning backup items such as a spare patient cable, front-end device, display monitor, and other
equipment are recommended on hand to prevent delayed treatment due to an inoperable device.
3.
Windows compatibility, updates and anti-virus policy: The Connex Cardio™ software has been fully tested
with Windows 7 Professional Service Pack 1, Windows 8.1 Professional, and Windows 10 Pro operating
systems. The Connex Cardio software has also been tested with Windows Server 2008 R2 Service Pack 1 and
Windows Server 2012 R2. Although it is unlikely that Windows updates and security patches affect Connex
Cardio functionality, Mortara 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 Connex
Cardio with corporate anti-virus software packages has been evaluated. Mortara recommends excluding the
Connex Cardio 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.
4.
No other non-recommended PC application software should be running while the Connex Cardio application is
being used.
5.
It is recommended that all resting ECG 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.
6.
To prevent delivery of malware into the system Mortara recommends that institution operating procedures are
written to prevent malware to be transmitted into the system from removable media.
7.
The WAM will only work with receiving devices that are equipped with the appropriate option.
8.
This WAM is not recommended for use in the presence of imaging equipment such as Magnetic Resonance
Imaging (MRI) and Computed Tomography (CT) devices, etc.
9.
The following equipment may cause interference with the WAM RF channel: microwave ovens, diathermy
units with LANs (spread spectrum), amateur radios, and government radar.
10. AA batteries are known to leak their contents when stored in unused equipment. Remove battery from WAM
when not used for an extended period of time.
11. Be careful to insert the correct lead wire into the connector block with the appropriate input connector by
matching the lead wire labels to the WAM or AM12 lead labels.
8
USER SAFETY INFORMATION
Notes
1.
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.
2.
8-hour timeout expiration is automatically controlled by the system. Each operation that occurs (e.g. Exam
Search, Patient Search, editing exams, starting an exam, etc.) will reset the timeout start time. When there is no
interaction with the system for the timeout duration, the user is prompted to enter login information.
3.
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. Scheduled orders are not available. An exam can be conducted
with manually entered demographics and will be stored locally. When the server comes available, the user is
prompted with a list of unsent exams and a selection to send exams to the modality manager database.
4.
Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper
analysis performed by the device.
5.
Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
6.
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
7.
If an electrode is not properly connected to the patient, or one or more of the patient cable lead wires is
damaged, the display will indicate a lead fault for the lead(s) where the condition is present.
8.
A thick baseline presentation on the display while using the AM12 may be due to a calibration error. Review
the LED indicator on the AM12 to ensure the unit is connected, or disconnect and reconnect to the PC USB port
to re-calibrate.
9.
The WAM will automatically start flashing LEDs if the batteries have been discharged below 1.0 volts.
10. During normal WAM/AM12 operation, the green LED will display continuously.
11. If the WAM battery cover is opened during transmission, the device will stop transmitting. The battery must be
reinserted and the cover must be applied to resume operation.
12. The WAM will automatically turn off (LEDs off) if the battery has been severely discharged.
13. The WAM will automatically turn off when the electrocardiograph is powered down.
14. The WAM will automatically turn off after being disconnected from the patient. This will happen regardless of
Connex Cardio battery/AC power state.
15. A thick baseline presentation on the display while using the WAM may be due to the WAM being turned off,
having no battery, not being paired correctly, operating out of range, or due to a calibration error. Review the
LED indicator and auditory advisory on the WAM to ensure the unit is turned on, has proper battery level, is
paired correctly, and is within recommended proximity of the electrocardiograph, or power cycle the WAM to
re-calibrate.
16. As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
- Type CF, defibrillation-proof applied parts.
9
USER SAFETY INFORMATION
17. 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.
18. 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:
Relative humidity:
-20 C to 60 C (-4 F to 149 F)
10% to 95%, non-condensing
19. Allow the device and any computer equipment used to stabilize within its intended operating environment
for a minimum of two hours prior to use. Refer to the computer equipment user manual for allowable
environmental conditions. The allowable environmental conditions for the AM12 and WAM acquisition
modules are as follows:
Ambient temperature:
Relative humidity:
10 C to 40 C (50 F to 104 F)
10% to 95%, non-condensing
20. The WAM is UL classified:
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, IEC60601-2-25,
10
5. EQUIPMENT SYMBOLS AND MARKINGS
Symbol Delineation
Defibrillation protection in patient cable
Defibrillator-proof type CF applied part
General Warning
Consult instructions for use
PC
USB connection to PC
Do not dispose as unsorted municipal waste. Per European Union
Directive 2002/96, requires separate handling for waste disposal according
to national requirements
NOTE: Refer to the manual(s) accompanying the device that pertain to the computer hardware for
additional definitions of symbols that may be present.
11
EQUIPMENT SYMBOLS AND MARKINGS
Package Symbol Delineation
This side up
Fragile
Keep Dry
Keep Away from Heat
Acceptable Temperature Range
12
6. 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
1.
2.
3.
Disconnect the power source. Remove cables and lead wires from device before cleaning.
For general cleaning of cables and lead wires, use a soft, lint-free cloth lightly moistened with a mild soap
and water solution. Wipe and air dry.
For disinfecting the exterior surfaces of the device, patient acquisition module, cables, and lead wires, wipe
exterior using:
Clorox Healthcare® Bleach Germicidal Wipes (use according to instructions on product label), or
a soft, lint-free cloth with a solution of Sodium Hypochlorite (10% household bleach and water solution)
minimum 1:500 dilution (minimum 100 ppm free chlorine) and maximum 1:10 dilution as recommended
by the APIC Guidelines for Selection and Use of Disinfectants
WARNING: Prevent liquid from penetrating the device and do not attempt to clean/disinfect
the device or patient cables by submerging into a liquid, autoclaving, or steam cleaning. Never expose
cables to strong ultra-violet radiation. Do not sterilize the device or ECG lead wires with Ethylene
Oxide (EtO) gas.
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.
13
GENERAL CARE
14
4. ELECTROMAGNETIC COMPATIBILITY (EMC)
Electromagnetic compatibility with surrounding devices should be assessed when using the device.
An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic
compatibility (EMC) has been performed on the device according to the international standard for EMC for medical
devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The device should not be used adjacent to, or stacked on top of other equipment. If the device must be used adjacent
to or stacked on top of other equipment, verify that the device operates in an acceptable manner in the configuration
in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical
equipment. See the appropriate EMC table for recommended separation distances between the radio equipment and
the device.
The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in
increased emissions or decreased immunity of the equipment.
15
ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment: Guidance
RF Emissions CISPR 11
Group 1
The equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and not likely to cause
any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class A
Harmonic Emissions
IEC 61000-3-2
Complies
The equipment is suitable for use in all establishments other
than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for
domestic purposes.
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
Compliance Level
Electromagnetic Environment: Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
+/- 1 kV differential
mode
+/- 2 kV common
mode
+/- 1 kV differential
mode
+/- 2 kV common
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips,
short
interruptions,
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
Mains power quality should be that of a typical
commercial or hospital environment.
Power frequency
(50/60 Hz)
magnetic field
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.
16
ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment: Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
 3 .5 
d
 P
 3Vrms 
 3 .5 
d
 P
 3V / m 
80 MHz to 800 MHz
 7 
d
 P
 3V / m 
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya, should
be less than the compliance level in each frequency
rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the
equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the equipment.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
17
ELECTROMAGNETIC COMPATIBILITY (EMC)
Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the Equipment
The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
equipment as recommended in the table below, according to the maximum output power of the communications
equipment.
Rated Maximum Output Power
of Transmitter W
Separation Distance According to Frequency of Transmitter (m)
150 KHz to 800 MHz
800 MHz to 2.5 GHz
d  1 .2 P
d  2 .3 P
0.01
0.1 m
0.2 m
0.1
0.4 m
0.7 m
1
1.2 m
2.3 m
10
4.0 m
7.0 m
100
12.0 m
23.0 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the
absorption and reflection from structures, objects, and people.
18
5. INTRODUCTION
Manual Purpose
This manual is intended to provide the user with information about the Connex Cardio resting electrocardiograph’s
display screen, menu structure, icons, and navigation tools pertaining in the following sections:







Using Connex Cardio
Preparing the Patient
Using MWL/Patients
Record an ECG
Context menus
Exam Search
System Settings
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.
Intended Use
The Connex Cardio Electrocardiograph is a multi-channel electrocardiograph product used for acquiring, analyzing,
displaying and printing resting ECG’s. The Connex Cardio is a 12-channel diagnostic electrocardiograph intended
for recording and printing ECG’s of adult and pediatric patients. The acquired ECG will be displayed for quality
check purpose, analyzed using the Mortara VERITAS resting interpretation, optionally printed, stored and/or
transmitted to a ECG Management System or Hospital Information System. The device is not intended to be used as
a vital signs physiological monitor.
It is a system comprised of a Mortara ECG amplifier (Wireless Acquisition Module [WAM] or AM12 Patient Cable)
and an off-the-shelf personal computer with Mortara software application that allows clinicians to collect ECGs on
patients during routine visits. The patient populations for which the device will be used may be healthy or diseased
of any age. ECG’s are taken with the patient in the supine position. The Connex Cardio is intended to be used by a
licensed health care practitioner in a hospital, medical clinic and offices of any size, including Clinical Research
Organizations.
19
INTRODUCTION
Indications for Use
The Connex Cardio electrocardiograph is a non-invasive prescription device.
 The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
 The device is indicated for use to provide interpretation of the data for consideration by a physician.
 The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting
on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
 The interpretations of ECG offered by the device are only significant when used in conjunction with a
physician over-read as well as consideration of all other relevant patient data.
 The device is indicated for use on adult and pediatric populations.
 The device is not intended to be used as a vital signs physiological monitor.
 The device is not designed for out of hospital transport.
 The device is not designed for use in highly invasive environments, such as an operating theatre.
System Description
Connex Cardio is a multi-lead, diagnostic, computer-based resting electrocardiograph capable of acquiring, viewing,
transmitting, printing, and storing ECG data.
Connex Cardio models ordered with the VERITAS™ resting ECG interpretation algorithm option are capable of
specific age and gender interpretation criteria. The VERITAS algorithm provides an over-reading physician with a
silent second opinion through diagnostic statements displayed on the ECG report. For additional information on the
VERITAS algorithm, please refer to the Physician’s Guide to VERITAS with Adult and Pediatric Resting ECG
Interpretation (see Accessories).
Connex Cardio can be configured with bidirectional connectivity and DICOM® protocol support.
The Connex Cardio application is integrated with a patient and exam management system that handles the
scheduling of exams, database storage and maintenance, exam and patient search, printing, communication with
external systems and dispatches the modality dependent acquisition and review functions. Connex Cardio can be
configured for data distribution. When so configured, the database resides on a server supporting a number of
networked client workstations.
The Connex Cardio Review software offers authorized users with the ability to schedule new exams when not linked
to an external scheduling system, view reports, enter conclusions, and generate printed or electronic reports for
completed exams.
The Connex Cardio server, workstations, and review stations can be set up as Citrix® Application Servers for remote
access from client computers with Citrix XenApp™ installed.
The Connex Cardio supports print formats that include:
 Standard or Cabrera,
 3+1,
 3+3,
 12,
 6+6 channel in automatic mode;
 Single channel on one page (60 min of acquired ECG for rhythm strip (Full Disclosure) printing.
The Connex Cardio packing list includes:
 Acquisition module with lead wire set and accessory starter kit
 Software CD
 Physician’s Guide to VERITAS and User Manual PDFs on CD
20
INTRODUCTION
Acquisition Module Types
Two acquisition module types, the Connex Cardio Wireless Acquisition Module (WAM) or Connex Cardio AM12
patient cable, for ECG acquisition are used with Connex Cardio.
WAM with Lead Wires
Figure 1 WAM with Lead Wires
Replaceable
Lead Wires
12-Lead ECG button
Power On/Off
Rhythm button
Battery compartment
LED Indicators
The WAM incorporates frequency-hopping technology in the 2500 MHz frequency range with 40,000 Hz ECG
acquisition and is operated by two buttons located on the front of the device when used with Connex Cardio:
1.
2.
Power On/Off
Acquiring a 12-lead ECG
NOTE: Rhythm button is non-functional for use with Connex Cardio.
The WAM uses one AA alkaline, 1.5V battery for approximately 8-hours of continuous operation.
WARNING: Use of other cells may present a risk of fire or explosion.
USB Transceiver Key (UTK)
The UTK connected to the Connex Cardio USB port receives ECG signals from the
paired WAM for presentation of the electrocardiogram. The UTK connected to USB
cable (6400-015) from the PC port is positioned in an unobstructed location.
21
INTRODUCTION
WAM LED Indicators
LED
+ Audio
MODE
GREEN off
YELLOW off
Intermittent beeping
WAM is on but not paired to an electrocardiograph, is
out of range of the paired electrocardiograph.
YELLOW solid or flashing
GREEN off
One or more leads are not connected properly.
GREEN solid
YELLOW off
No lead fail condition is detected; battery is OK.
GREEN solid
YELLOW off
Intermittent beeping
Blinking LED
(yellow or green depending
on lead fault status)
GREEN off
YELLOW off
WAM is collecting a 10-second ECG.
WAM has detected a low battery condition. Replace
the battery within 15 minutes.
1 second audio on, then
device turns off.
WAM has detected a very low battery status and
powered off.
AM12 with Lead Wires
Figure 2 AM12 with Lead Wires
Replaceable
Lead Wires
12-Lead ECG button
LED
Indicators
Rhythm button
USB cable
The AM12 is available for a traditional wired connection with direct USB connection and 40,000 Hz ECG
acquisition. The 12-Lead ECG button can be used to acquire a 12-lead ECG at the patient’s side.
NOTE: Rhythm button is non-functional for use with Connex Cardio.
Lead Fail
Lead fail is done automatically through visual communication with the LEDs located on the front of the WAM and
AM12. A yellow LED (solid or flashing) indicates a lead fail condition is present. A solid green LED indicates
proper lead connection as well as adequate WAM battery voltage for ECG acquisition.
22
INTRODUCTION
Connex Cardio Software Installation Process
Navigate to the location where the software to be installed is loaded.
Double click on the application file Setup. If prompted by a User Account Control window, allow the program to make changes to the computer by clicking Yes. Note: User must have Administrator access to complete the installation.
The following Exam setup prompt window appears informing Mortara PDF as a component to be installed on the
user’s machine. Click Install. The following Connex Cardio v1.X.X Setup window will appear, click Next to continue. 23
INTRODUCTION
Setup Type: The Choose Setup Type window details the setup types that can be selected:
There are three available choices for the installation process:
Simple: This option is to be selected if the user wants the exam result to be obtained in a PDF format only. The
choice Simple details the configuration of the system to export the PDF exam reports to a directory by
automatically installing and configuring both Connex Cardio and ELI Link. Do not use this option if installing
multiple Connex Cardio systems that are to be connected to a common ELI Link.
EHR Integrated: This option is to be selected when the user has a supported EHR (Electronic Health Record)
system that can integrate with Connex Cardio. The choice EHR Integrated installs the necessary components and
configures the system to launch from a supported EHR system. The choices of EHR’s in the list include:
AllScripts, eClinical, Epic, and default.
Advanced: This option is to be selected for any other type of installation or integration with a 3rd party system,
including HL7, DICOM, XML, or PDF. The choice Advanced does not automatically install or configure ELI
Link – this needs to be done separately. Note: if DICOM connectivity is desired, each Connex Cardio system
needs to be licensed for DICOM. 24
INTRODUCTION
The detailed configuration of the above three Setup Types is as follows:
If you select the Simple option Simple – Click on the Simple choice and a window with the following three installation options will be displayed:
Standalone: Choose this option if the user wants to
load a single Connex Cardio application with the
Database Server functionality included on a single
computer.
Server: Choose this option if the user wants to
configure this system to have Database Server
functionality and be networked to separate Client
systems that will run the modality.
Client: Choose this option if you are loading the
Connex Cardio application on a computer that will
be networked to the Database Server functionality
on a different computer.
Note: If installing a Client system, install the
Server system that the Client will be connected
to first.
If you select the Standalone option The following window containing the language
dropdown options (English by default) and the
information for the path to place the PDF file on the
C:\ drive will be displayed. If the user wants to setup a
different location, click the Browse button and set the
desired location for the PDF file.
Upon selecting the desired language and location,
click Next and the user will be navigated to the final
installation window. If you select the Server option The following window containing the language
dropdown options (English by default) and the
information for the path to place the PDF file on the
C:\ drive will be displayed. If the user wants to setup a
different location, click the Browse button and set the
desired location for the PDF file. ELI Link
automatically installs on the server, and Connex
Cardio Server is automatically configured to
communicate with the installed instance of ELI Link.
25
INTRODUCTION
Upon selecting the desired language and location, click Next and the user will be navigated to the final installation
window. If you select the Client option The following window containing the language
dropdown options (English by default) and the
information for the Server Address will be displayed.
Upon selecting the desired language and server
location, click Next and the user will be navigated to
the final installation window. 26
INTRODUCTION
If you select the EHR Integrated option EHR Integrated – Click on the EHR Integrated choice and a window with the following three installation options
will be displayed:
Standalone: Choose this option if the user wants to
load a single Connex Cardio application with the
Database Server functionality included on a single
computer.
Server: Choose this option if the user wants to
configure this system to have Database Server
functionality and be networked to separate Client
systems that will run the modality.
Client: Choose this option if you are loading the
Connex Cardio application on a computer that will
be networked to the Database Server functionality on
a different computer.
Note: If installing a Client system, install the
Server system that the Client will be connected
to first.
If you select the Standalone option The following window containing the language
dropdown options (English by default) and the EHR
dropdown information will be displayed.
The available options of EHRs in the drop-down menu
include Allscripts, eClinicalWorks, Epic, and Default
Upon selecting the desired language and supported
EHR, click Next and the user will be navigated to the
final installation window.
If you select the Server option The following window containing the language
dropdown options (English by default) will be
displayed.
Upon selecting the desired language, click Next and
the user will be navigated to the final installation
window. 27
INTRODUCTION
If you select the Client option The following Select Language, EHR and Server
Address window containing the language dropdown
options (English by default), EHR dropdown options
and the field for Server Address (Localhost by
default) will be displayed.
Upon selecting the desired language, supported EHR
and server address, click Next and the user will be
navigated to the final installation window.
28
INTRODUCTION
If you select the Advanced option Advanced – Click on the Advanced choice and a window with the following three installation options will be
displayed:
Standalone: Choose this option if the user wants to
load a single Connex Cardio application with the
Database Server functionality included on a single
computer.
Server: Choose this option if the user wants to
configure this system to have Database Server
functionality and be networked to separate Client
systems that will run the modality.
Client: Choose this option if you are loading the
Connex Cardio application on a computer that will
be networked to the Database Server functionality
on a different computer.
Note: If installing a Client system, install the
Server system that the Client will be connected
to first.
If you select the Standalone option The following Server Configuration window will be
displayed containing the default Database Port number
(5432) and an option to enable or disable the Unique
Patient option.
Database Port: It is recommended that the User uses
the default port number for the installation. If the port
is already in use the installation tool will alert the user
that the port is already taken and that a new port
number will need to be entered to continue with the
installation.
Unique Patient: This option defaults to an enabled
(checked) condition to configure the system to utilize
the Patient ID field as a unique identifier for patient
demographic information. This is the most commonly
used system configuration.
The Unique Patient option box can be UNCHECKED to NOT use the Patient ID field as a unique identifier for
patient demographics. Choose to uncheck the Unique Patient ID when patients can be entered from different
institutions (such as scanning centers) that use different ID schemes. Choose to uncheck the Unique Patient when
the Patient ID field is not used to identify a patient, such as with clinical research studies.
29
INTRODUCTION
Set Database Location: Selection of this button
allows the User to Browse to a location for the Connex
Cardio application and database other than the local
default (C:\) directory. This is beneficial when it is
necessary to define the application and database
locations on a different data drive.
 This selection allows a preview of Disk
Usage to ensure requirements are met.

The Reset selection will return all changes to
default settings.

Select Next to return to the Server
Configuration window to continue the
installation steps.

Select Cancel to exit the installation process.
Back at the Server Configuration window, click Next and the user will be navigated to the final installation
window.
If you select the Server option The following Server Configuration window will be
displayed containing the default Database Port number
(5432) and an option to enable or disable the Unique
Patient option.
Database Port: It is recommended that the User uses
the default port number for the installation. If the port
is already in use the installation tool will alert the user
that the port is already taken and that a new port
number will need to be entered to continue with the
installation.
Unique Patient: This option defaults to an enabled
(checked) condition to configure the system to utilize
the Patient ID field as a unique identifier for patient
demographic information. This is the most commonly
used system configuration.
The Unique Patient option box can be UNCHECKED to NOT use the Patient ID field as a unique identifier for
patient demographics. Choose to uncheck the Unique Patient ID when patients can be entered from different
institutions (such as scanning centers) that use different ID schemes. Choose to uncheck the Unique Patient when
the Patient ID field is not used to identify a patient, such as with clinical research studies.
30
INTRODUCTION
Set Database Location: Selection of this button
allows the User to Browse to a location for the Connex
Cardio application and database other than the local
default (C:\) directory. This is beneficial when it is
necessary to define the application and database
locations on a different data drive.
 This selection allows a preview of Disk
Usage to ensure requirements are met.

The Reset selection will return all changes to
default settings.

Select Next to return to the Server
Configuration window to continue the
installation steps.

Select Cancel to exit the installation process.
Back at the Server Configuration window, click Next and the user will be navigated to the final installation window.
If you select the Client option The user will be navigated to the final installation window.
31
INTRODUCTION
Final Installation Window: Click Install to load the software files to the defined location.
The wizard will now load the software files to the defined location.
During the software installation, you may be prompted
to install device driver software. This is needed for the
AM12 or WAM UTK drivers.
Select Install this driver software anyway
32
INTRODUCTION
Click Finish to complete the installation process of Connex
Cardio and exit the window.
As the Connex Cardio installation finishes, Microsoft SQL
Server and ELI Link will install automatically on the system.
If prompted for permissions, allow the installation of both
programs. When ELI Link finishes installing a window will appear
informing that for the installation to be successful a system
restart is required. Click Yes to restart the system now or No to manually restart the system later. The system should be
restarted before using Connex Cardio to ensure full
functionality. 33
INTRODUCTION
DICOM Feature Activation
Activation is required only to enable DICOM functionality.
To prepare for activation, run the Modality Manager Activation Tool accessed from the following menus:
 Start menu
 All Programs

Mortara Modality Manager
 Modality Manager Activation Tool (click Yes when prompted to allow changes to the computer)
Once your system serial number is entered, this utility generates the site code that is needed for activation by
Technical Support personnel. You can click on the Copy to Desktop or the Copy to Clipboard button to generate
a file to be e-mailed Technical Support
Technical Support will return an activation code that can be typed or copied and pasted into the white space above
the "Extend License" button. Select the Extend License button to activate the DICOM feature. Contact Technical
Support personnel for further information.
34
INTRODUCTION
Connex Cardio Login and Main Display
Use the
application.
icon on the desktop to start the Connex Cardio
If not set up with "single sign on", Connex Cardio will require
user credentials on startup. Enter your Connex Cardio Username
and Password and then select OK to open the application main
menu.
Note: The default Username and Password are "admin"
(password is case-sensitive).
Upon successful login, the Connex Cardio application screen will
appear displaying the user name and software version in the
bottom left corner.
The icons in the center of the screen indicate workflow tasks in
presumed order left to right. Click the icon representing workflow
task you wish to perform.
Hover the mouse over an icon to display its function.
35
INTRODUCTION
Connex Cardio Program Icons and Descriptions
Icon and Hover Text
Description
Desktop shortcut icon to launch the Resting ECG application.
MWL/Patients
STAT ECG
Opens a window with two selectable tabs. A MWL (Modality Work List)
tab allows exam scheduling (when no orders interface exists) and
schedule review. A Patients tab allows addition of new patient
information and editing of existing patient information.
Use to bypass Exam Data Entry and proceed directly to real-time ECG
for immediate acquisition
Use to enter exam data and begin real-time ECG acquisition
Start a Resting Exam
Use to search for exams in the database using filters.
Exam Search
Use to configure user preferences for the Worklist and to change the
password.
User Preferences
System Configuration
For administrative users to configure system settings such as
creating/modifying users, changing the Connex Cardio default
acquisition criteria, defining archive directories, and so on.
Use to close the Connex Cardio application and return to the desktop.
Exit
Use to minimize or exit the application and return to the desktop.
36
INTRODUCTION
User Roles and Permissions
Connex Cardio supports a workflow-oriented setup for defining user roles and controlling user access to the various
operations. Role assignments are comprised of a set of permissions for each user type (e.g. IT administrator, clinical
administrator, ECG Tech, and so on).
Each user can be assigned a single role or a combination of roles. Some roles will include permissions assigned to
other roles where applicable. After installation, a single user is created, with the role of "IT Administrator". Before
using Connex Cardio, this user should log in and create required users and roles.
Roles
Permission Assignment
IT Administrator
Manage user permissions; manage personnel lists; export settings; archive
settings; workflow configuration; storage system configuration; unlock exams;
view audit trail reports; export service logs; create and modify groups.
Clinical Administrator
Manage database exams (delete, archive, and restore); copy exams offline to
share with Mortara personnel or other sites; view audit trail reports; modify modality
settings (profiles, protocols, and other resting ECG specific settings); reconcile;
export service logs.
Create new patient orders; associate an order with an existing patient; modify
demographics of an existing patient; export service logs.
Schedule Procedure
Scheduling and order entry is only available when Connex Cardio is not linked to
an external scheduling system.
Patient Hookup
(Start a Resting Exam)
Edit Holter Diary
Ability to start a test using Start a Resting Exam icon. Includes the ability to create
a new patient; associate an order with an existing patient; export service logs.
Not applicable to the Connex Cardio application.
View Exams/Reports
Review exams and final reports only. Includes the ability to search exams, view
and print reports; export service logs.
Prepare Report
Review and edit exams to move them from an acquired state to the edited state.
Includes ability to search exams and view and print reports; export service logs.
Review and Edit Report
Review and edit exams to move them to the reviewed state. Includes ability to
search exams and view and print reports; modify and create conclusions; export
service logs.
Edit Conclusions
Create and modify conclusions. Includes ability to review exams and final reports
only; search exams and view and print reports; export service logs.
Sign Report
Ability to move exams to a signed state. Includes ability to review exams and final
reports; search exams and view and print reports; export service logs. May
require user authentication.
Export Report
Ability to export a PDF and XML file when features are enabled. Must be
assigned in conjunction with another role (e.g. Review, View, or Conclusions).
Refer to User Role assignment table with details.
37
INTRODUCTION
Connex Cardio Workstation Specifications
Feature
Specification*
Input Channels
Simultaneous acquisition of all 12 leads
Standard Leads Acquired
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Waveform Display
Compatible with 1024 x 768, 1366 x 768, 1280 x 800, 1680 x 1050, 1920 x
1080, 1920 x 1200, and 2736 x 1824 resolutions
Compatible Operating Systems
Compatible with: Microsoft® Windows® 7 Professional 32 bit or 64 bit and
Microsoft® Windows® 10 Pro 64-bit operating systems**
Storage Capacity
100 GB SATA hard disk drive minimum
Memory 2 Gb minimum
USB ports 3 minimum
Archive
Network or external USB disks (standalone installation)
Input devices
Standard keyboard and 2-button scroll mouse
DVD drive
DVD-ROM, DVD-DRIVE
Network Support
Option to utilize industry-standard database server
Network Infrastructure
100 Mbps connection or better required for use with server
Printing Device
HP M501dn Windows printer with HPUPD PCL 5 driver or equivalent
Optional Function
Mortara VERITAS resting ECG interpretation algorithm with age and
gender specific criteria; connectivity with bidirectional communication
On-Screen Tools
Time and amplitude calipers; 40 Hz and 150 Hz noise filters; various lead
layouts and grid
Digital Sampling Rate
40,000 s/sec/channel used for pacemaker spike detection;
1,000 s/sec/channel used for recording and analysis
Gain Setting
2.5, 5, 10, 20 mm/mV
Report Formats
Standard or Cabrera; 3+1, 3+3, 6, 6+6, or 12 channel
Rhythm Print Format
Single lead of up to 60 minutes of data
Frequency Response
0.05 – 300 Hz
Filters
High-performance baseline filter; AC interference filter 50/60 Hz; low-pass
filters 40 Hz, 150 Hz, 300 Hz
Power Requirements
Dependent on computer, 100 – 240 VAC at 50/60 Hz
* Specifications subject to change without notice.
**Installations that include ELI Link 5.0 and later require 64-bit systems (Simple – Standalone; Simple – Server).
38
INTRODUCTION
Connex Cardio Minimum Server Specifications
Feature
Server Minimum Specifications*
Processor
Performance equivalent to an Intel Xeon class; Quad-core with
hyperthreading
Graphics
1024 x 768
RAM
4 GB
Operating System
Microsoft® Windows® 2008 Server R2 (32-bit, 64-bit)
Microsoft® Windows® 2012 R2 (32-bit, 64-bit)
*If installing ELI Link with Connex Cardio, system requires 64-bit OS to
operate both. (Simple Installer will automatically load ELI Link and
Connex Cardio together.)
System Disk
100 GB for OS and product installation (RAID recommended for data
redundancy)
Data Disks
550 GB hard drive space available
HD controller with 128 MB read/write cache
(RAID recommended for data redundancy)
Archive
Network or external USB drive
Software Installation
CD-ROM
Network
100 Mbps connection or better
Input Devices
Standard keyboard and mouse
*Specifications subject to change without notice.
Requirements for Connex Cardio as a Citrix XenApp
Requirements*
Client Machines that will run
Citrix XenApp
Microsoft® Windows® 7 Professional (64-bit)
Microsoft® Windows® 10 Professional (64-bit)
Citrix Receiver
Internet Browser – any that is supported by Citrix
Citrix Domain Controller Server
Citrix XenDesktop Enterprise Edition 7.9
Any operating system supported by Citrix
Citrix App Servers
Microsoft® Windows® 7 Professional (64-bit)
Microsoft® Windows® 10 Professional (64-bit)
Citrix Virtual Delivery Agent 7.9
Connex Cardio Client software (EMR configuration not compatible)
*Requirements subject to change without notice.
39
INTRODUCTION
WAM Specifications
Feature
Specification*
Instrument Type
12-lead wireless acquisition module for resting ECG
Input Channels
12-lead signal acquisition and transmission
ECG Leads Transmitted
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6
WAM Transmission Protocol
Bidirectional and frequency hopping; beacon and response method
links a single acquisition module to a single electrocardiograph
Frequency Range
2400.96 MHz to 2482.56 MHz
WAM and Receiver Distance
Approximately 10 feet (3 meters)
Lead Set
RA, LA, RL, LL, V1, V2, V3, V4, V5, and V6 (R, L, N, F, C1, C2, C3,
C4, C5, and C6) with detachable lead wires
Sampling Rate
40,000 samples/second/channel acquisition; 1,000
samples/second/channel transmitted for analysis
Resolution
1.875 microvolt LSB
User Interface
Two-button operation: ON/OFF and 12-lead ECG acquisition; Rhythm
button is non-functional
Defibrillator Protection
Complies with AAMI standards and IEC 60601-2-25
Special Functions
LED indication of power status, operating mode, lead fail, and
remaining battery charge
Device Classification
Type CF, battery operated
Weight
6.7 oz. (190 g) with battery
Dimensions
4.45 x 4.25 x 1.1” (11.3 x 10.8 x 2.79 cm)
Battery
1 AA alkaline battery typically powers WAM for acquisition of 250
resting ECGs
* Specifications subject to change without notice.
40
INTRODUCTION
WAM and AM12 Accessories
Part Number
Description
9293-046-07
COMBINER WAM LEADS 10 POS GRAY
9293-046-60
LEAD SET WAM 10 WIRE BANANA AHA GRAY
9293-046-61
9293-046-62
LEAD SET WAM 10 WIRE BANANA IEC GRAY
RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY
9293-046-63
RPLCE LD SET WAM/AM12 LIMBS BANA IEC GRY
9293-046-64
RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY
9293-046-65
RPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRY
9293-046-66
RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY
9293-046-67
RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY
9293-047-60
LEAD SET WAM 10 WIRE CLIPS AHA GRAY
9293-047-61
9293-047-62
LEAD SET WAM 10 WIRE CLIPS IEC GRAY
RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY
9293-047-63
RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY
9293-047-64
RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY
9293-047-65
RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY
9293-047-66
RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY
9293-047-67
RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY
Electrodes
Part Number
Description
9300-032-50
ECG MONITORING ELECTRODES CASE 300
9300-033-51
ELECTRODE RESTING TAB BOX/500
9300-033-52
ELECTRODE RESTING TAB CASE/5000
042729
CardioSens / Ultra II Electrodes
Acquisition Modules
Part Number
Description
9293-048-64
30012-019-75
CONNEX CARDIO WIRED PATIENT CABLE (AM12)
30012-021-51
UTK (Wireless receiver / transceiver)
CONNEX CARDIO WIRELESS ACQUISITION MODULE (WAM)
Manuals
Part Number
Description
9515-001-51-CD
PHYSICIAN'S GUIDE ADULT & PEDIATRIC UM ON CD
9515-218-50-CD
CONNEX CARDIO USER MANUAL PDFS ON CD
9515-218-50-ENG
CONNEX CARDIO USER MANUAL ENGLISH
9515-166-50-CD
ELI LINK USER MANUALS ON CD
Contact your dealer or go to www.mortara.com for more information.
41
INTRODUCTION
Connex Cardio Network Operation in a Distributed Configuration
The Connex Cardio network capabilities leverage a common database across multiple networked Connex Cardio
workstations where exams will be conducted and Connex Cardio Review stations where acquired exams can be
reviewed and edited.
A distributed configuration is comprised of a dedicated server and a number of networked client Connex Cardio
workstations and Connex Cardio Review Stations sharing the same database.
A distributed configuration supports efficient operation for a busy department to:

Create logins for all users at a single location who can log into any networked station.

Define system settings at a single location for all networked workstations and review stations.

Manually schedule exam orders, when no orders interface exists, that are available to all Connex Cardio
workstations regardless of the lab location.

Access and update Patient Information, exam data, and final reports from multiple locations.

Start exams utilizing scheduled orders received from the institution information system with a single
DICOM or HL7 interface to the shared database. Refer to the ELI Link Administrator manual for network
interface configuration instructions.

Selectively search the database to review any completed exam’s full disclosure data. This includes the
ability to edit, sign, print, and export the final report from multiple Connex Cardio workstations and review
stations on your network, dependent on the user permissions.

Manage the stored data for all exams with ability to view audit trails, create groups, configure workflow,
troubleshoot issues, and archive/restore/delete exams at a single location according to user permissions.
Microsoft Updates
Mortara recommends that all Connex Cardio 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.
The following guidelines apply for Microsoft updates:

Customer is responsible for applying Microsoft updates.

Configure Microsoft updates to be manually applied.
o
Turn automatic Windows update off and run it periodically as a manual action.

Do not install Microsoft updates during active use of the product.

Run a functional test after any update which includes conducting a test exam as well as importing an order
and exporting results (if activated) before running patient exams.
Each Connex Cardio product release is tested against the cumulative Microsoft updates at the time of product
release. There are no known Microsoft update conflicts with the Connex Cardio application. Please contact
Technical support if conflicts are identified.
42
INTRODUCTION
Anti-Virus Software
Mortara recommends the use of anti-virus (AV) software on computers hosting the Connex Cardio application. The
following guidelines apply in the use of AV software:

Customer is responsible for installation and maintenance of AV software.

AV software updates (software and definition files) should not be applied during active use of the Connex
Cardio application.
o

AV patch updates and system scans should be scheduled for time periods when the system is not
actively in use or should be performed manually.
AV software must be configured to exclude files/folders as defined in Cautions in User Safety Information
and below:
o
Mortara recommends excluding the Connex Cardio database folder (normally
C:\ProgramData\MiPgSqlData) from the folders to be scanned.
If a technical support issue is reported, you may be asked to remove the virus scanning software to allow
investigation of the issue.
Encrypt Protected Health Information (PHI) Stored in Connex Cardio
The Connex Cardio database may be configured for Windows Encrypted File System (EFS) for protection of patient
data security. EFS encrypts individual files with a key stored with the Windows user account. Only the Windows
user that encrypts or creates new files in an EFS-enabled folder can decrypt the files. Additional users can be
granted access to individual files by the original account that encrypted the files.
NOTE: The Connex Cardio system database must be unencrypted prior to performance of any software
upgrades.
43
INTRODUCTION
Contact technical support if your facility requires this security feature.
44
6. USING CONNEX CARDIO
A typical workflow on Connex Cardio consists of the following actions:
Schedule an exam
An exam is scheduled for a patient; exam data such as referring physician and requested date and time are entered. If
the patient does not exist in the database, patient demographic data is entered. Orders may be managed through the
Connex Cardio Modality Worklist (MWL) feature, or through an external scheduling system interface.
Start a resting exam
The patient is connected to the Connex Cardio through the data acquisition module, data is collected and one or
more 10 second ECGs are saved for analysis and further processing. An exam may fulfill an order or can be an adhoc exam, in which case a patient must be selected from the database or a new patient created with demographic
data entered. Connex Cardio can collect multiple ECGs in a single acquisition session that may last for up to one
hour, dependent on system settings. ECGs and a full disclosure rhythm page may be previewed and printed on the
Windows default printer during an acquisition session. The ECG records can be modified with appropriate user
permissions.
Acquiring a STAT ECG exam
The STAT ECG icon can be selected when there is an immediate need to acquire an ECG without prior
demographic data entry. The patient is connected to the Connex Cardio through the data acquisition module, data is
collected and one or more 10 second ECGs are saved for analysis and further processing. Patient Information can be
accessed after the ECG is acquired where the Last Name field has been automatically populated with STAT ECG.
These saved exams can be found through exam search to update patient information at a later time.
Reviewing and signing an exam and printing a report
In order to edit an exam and electronically sign it, you must have the necessary permission to do so. The program
will automatically start the Review mode after exiting the acquisition session with the first ECG that was collected
during the session. Other acquired ECGs are saved and can be found through exam search.
Real-time Display
Real-time ECG may be displayed in one of two full-screen views. The standard (12x1) full-screen view displays
10 or more seconds of continuous waveform data for each of the 12 leads. The split-screen (6x2) view displays 5 or
more seconds of continuous waveform data for each of the 12 leads. The six (6) limb leads appear on the left and the
six (6) precordial leads appear on the right side of the screen.
To change the default display format for the real-time ECG view, see the Settings section in this manual.
NOTE: The amount of data displayed may vary and depends on display speed and display size.
45
USING CONNEX CARDIO
46
USING CONNEX CARDIO
Recording an ECG
Connex Cardio can acquire single or multiple ECGs in real time, retrospectively, or in a timed sequence.
Prepare the patient for best conductivity between the skin surface and the electrode. Place the electrodes on the
patient according to lead placement guidelines. Ensure that the proper lead wire is firmly and correctly attached to
each electrode.
Select an existing order from the MWL tab, search for the patient from the Patients tab, or manually enter patient
demographics.
The real-time ECG display can be exited with selection of the Done
button to return to the Start a Resting
Exam display at any time. The user is prompted to select Yes or No when an ECG has not been acquired.
To acquire a real-time ECG:


Select the ECG button on the display to capture Best 10
or Last 10
12-lead ECG data.
o
BEST 10 captures the best quality, 10-second ECG accumulated within the full disclosure
o
LAST 10 captures the most recently acquired 10-second ECG
Or, select the ECG button
on the Connex Cardio WAM™ or the Connex Cardio AM12™ that will
capture either the BEST or LAST 10-seconds of acquired ECG dependent on Connex Cardio
configurations.
Preview Acquisition Screen
The ECG preview screen appears with an ECG report exactly as it will save and print upon exiting this display.

Select the Save
Exam display.

Select the Delete
another ECG.

Select the Review
button to save the ECG as reviewed, exit, and return to the Start a Resting
Exam display. The user is prompted to enter the reviewer’s name prior to exit.

Select the Sign
button to save the ECG as signed, exit, and return to the Start a Resting
Exam display. The user is prompted to enter the signer’s name prior to exit. When Legal Signature has
been defined in the workflow configuration settings, the signer is prompted to enter the user name and
password.

Select the Print ECG
button to save the ECG as acquired, exit, and return to the Start a Resting
button to discard the ECG and return to the real-time ECG display to capture
button to print the displayed ECG according to the Resting ECG settings.
47
USING CONNEX CARDIO
Timed ECG Capture
Connex Cardio can automatically acquire ECGs at preset time intervals for future review and processing on the full
disclosure screen. Automatic acquisition may be as frequent as every 20 seconds or once per a 60-minute period
(dependent on the amount of full disclosure time set by the administrator).
To acquire timed ECGs:

Prep the patient and place the electrodes in the correct locations (ensuring lead wires are securely attached).

Select ECG Timed Capture from the settings icon in the
upper right corner of the real-time ECG display.

Enable Auto Capture Time by checkbox.

Enter the frequency in the Set Capture Time (mm:ss)
window
o

20 seconds up to 59-minutes and 59-seconds.
Select OK to begin automatic ECG collection or Cancel to
exit the window. o

Message appears prompting a manual ECG capture Capture the first ECG to begin the timed ECG capture. The
time remaining to the next capture and the number of ECGs
captured is displayed in the lower right corner of the display.
ECGs are automatically captured according to the Full Disclosure duration defined by the administrator. ECG
capture automatically ends when the duration has been reached.
Automatic ECG capture can be manually ended with selection of the done
button.
Captured ECGs are saved and can be reviewed and edited using the Exam Search feature.
ECG Capture from the Full Disclosure Data Window
The full disclosure data window is located at the bottom of the ECG display screen. ECG data is displayed using a
single lead or three leads according to the settings.
To acquire a retrospective ECG:
48

Use a left mouse click anywhere in the full disclosure ECG to highlight 10-seconds of data. Once clicked,
the Page Up
, Page Down
, Select
, and Print Full Disclosure
buttons
become active allowing navigation and ECG selection.

Position the 10-second box of highlighted ECG anywhere in the full disclosure ECG using left mouse
clicks and the Page Up/Down buttons.

Select the ECG button to the right of the full disclosure
lead ECG.
to capture the highlighted 10-second 12-
USING CONNEX CARDIO
ECG Collection Using the Acquisition Module
ECG acquisition can be performed at the WAM or AM12 acquisition modules. Refer to the AM12 short-form
instruction card when using the AM12.
NOTE: The WAM must be synchronized to the UTK before Connex Cardio operation. The Universal
Transmitter/receiver Key (UTK) is a bidirectional device that links the PC’s USB port to the WAM.
Select the ECG button
on the WAM™ or the AM12™ to capture the last 10-seconds of acquired ECG.
Connecting the Acquisition Module
The AM12 connects to a USB port on the PC for signal acquisition. The Connex Cardio will automatically detect
the AM12 once it’s connected to the USB port.
The WAM communicates via the UTK (Universal Transmitter/receiver Key) connected to an active USB port on the
PC. The WAM is synchronized with the UTK making them a matched pair. Using the same UTK and WAM that
were last paired maintains their synchronization.
Pairing WAM with Connex Cardio
Start the Connex Cardio application. Navigate to the real-time display and:







Select the settings icon
in the upper right corner of the real-time display
Select WAM Pairing
Place the WAM (powered off) in close proximity to the UTK receiver connected to an Connex Cardio USB
port.
Select Start and then Yes
Power the WAM on.
A successfully paired message will display.
Select DONE.
NOTE: The wireless acquisition module (WAM) must be paired to a specific Connex Cardio prior to signal
acquisition.
NOTE: If both AM12 and the UTK are connected simultaneously, Connex Cardio will default to the AM12
over the UTK with WAM for acquisition.
NOTE: Disconnecting the UTK and connecting the AM12 will automatically cause the Connex Cardio to
switch to the AM12. It is not necessary to pair the same WAM with the same UTK to use it again.
49
USING CONNEX CARDIO
50
7. MWL/PATIENTS
The MWL/Patients icon
allows you to schedule exams and enter patient demographics information. Select
this icon to open a window for scheduling resting ECG exams and to view the existing schedule.
When Connex Cardio is linked to an external scheduling system, this information arrives from institution entered
orders.
When the icon is selected, a split window appears with two selectable tabs (MWL and Patients) on the left and
Patient or Order Information fields on the right, dependent on the selected tab.
A Search field and button are present below the tab selections.
MWL
Text that is entered in the search field will be used to search through the Modality Worklist (MWL) to display orders
that start with matching text in the Last Name, First Name, or Patient ID. A blank search field will list all orders.
MWL columns include Scheduled Date/Time, Patient ID, Last Name, First Name, Date of Birth, and Group. The
list can be sorted by a click on the column headers. A second click on the same header will reverse the column
order.
NOTE: Selection of an unavailable order (e.g. in use at another workstation, deleted, or canceled) will
result in a refresh of the listed orders.
Edit Order
Selection of an entry in the list will display
the Order Information as read-only. Select
the Manage button and click on the item
Edit Order to modify the order. Select the
Save Order button to save changes or
Cancel to cancel all changes.
NOTE: This function is not available
when an orders interface is enabled.
51
MWL/PATIENTS
New Order
A New Order button allows a Patient ID
or name search of patient information in
the database allowing addition of a new
order in the MWL list. A blank search
field will list all patients in the database.
When the patient does not exist in the database, Cancel the Patient Information search and select the Patients tab
to enter a new patient. Instructions are on the following page.
The patient information populates the Order Information at the right of the display. Additional order information
can be entered and the order saved. The Cancel button will close the order without saving.
When entering an order, use the Group drop-down list to assign the order to a specific group that has been
configured in the system settings. This is not necessary when there is no more than one Group.
Select the calendar icon in the bottom right corner of the
Order Information section to open a calendar for
selection of the scheduled order date and time. Date and
time may also be entered by typing in the Requested
Date/Time field.
Delete an Existing Order
Select an existing patient order by highlighting the line and then select
Manage and then Delete Order.
A warning message prompting delete confirmation will appear. Select
Yes to delete the order or No to cancel and return to the MWL listing.
Exit MWL/Patients
Select the Exit button when finished to return to the main menu.
52
MWL/PATIENTS
Patients
Text that is entered in the search field will be used to
search through the patient demographics in the
database to display any patients that start with
matching text in the Last Name, First Name, or Patient
ID.
Patients’ columns include Patient ID, Last Name, First
Name, and Date of Birth. The list can be sorted by
selecting the column headers. A second selection on
the same header will reverse the column order.
Edit Patient
Selection of an entry in the list will display the Patient Information as read-only. Select the Manage button and
then Edit to enable and modify the patient demographics fields.
Select the Save Patient button when finished to save changes or the Cancel button to return to read-only
demographics without saving changes.
New Patient
Selecting the Manage button and then New Patient
clears any selected patient information allowing addition
of a new patient in the list. The new patient information
can be entered in the demographic fields and the Save
Patient button selected to save it to the database. The
Cancel button will close the patient information
without saving.
Delete Patient
Select the Manage button and then Delete to remove patient demographics from the database.
NOTE: The Delete button is disabled when the patient demographics are associated with an existing order
or exam. All orders and exams for that patient must first be deleted before the patient demographics can
be deleted.
A warning message prompting delete confirmation will appear. Select
Yes to delete the patient demographics or No to cancel and return to the
Patients listing.
Exit MWL/Patient
Select the Exit button when finished to return to the main menu.
53
MWL/PATIENTS
54
8. RECORD AN ECG
Patient Preparation
Before attaching the electrodes, assure the patient fully understands the procedure and what to expect.
 Privacy is very important in assuring the patient is relaxed.
 Reassure the patient that the procedure is painless and that the electrodes on their skin are all that they
will feel.
 Make sure the patient is lying down and is comfortable. If the table is narrow, tuck the patient’s hands
under his/her buttocks to ensure their muscles are relaxed.
 Once all the electrodes are attached, ask the patient to lie still and to not talk. Explain this will assist you in
acquiring a good ECG.
Preparing Patient Skin
Thorough skin preparation is very important. There is natural resistance on the skin surface from various sources
such as hair, oil, and dry, dead skin. Skin preparation is intended to reduce resistance and maximize the quality of
the ECG signal.
To prepare the skin:
 Clip hair from electrode sites if necessary.
 Wash area with warm, soapy water or alcohol if dirty or oily.
 Dry skin vigorously with a pad such as 2 x 2 or 4 x 4 gauze to remove residue from cleaning, dead skin
cells and oil, and to increase capillary blood flow.
NOTE: With elderly or frail patients take care to not abrade the skin causing discomfort or bruising.
Patient Hookup
Correct electrode placement is essential for acquiring a diagnostically valid ECG.
A low resistance highly conductive pathway from the skin surface to the electrocardiograph provides superior noisefree waveforms. Good quality silver-silver chloride (Ag/AgCl) electrodes within their expiration date should be
used whenever taking an ECG.
TIP: Electrodes should be stored in an air-tight container. Electrodes will dry out if not stored properly
causing reduced adhesion and conductivity, leading to poor trace quality.
To Attach the Electrodes
1.
2.
3.
4.
Expose the arms and legs of the patient to attach the limb leads.
Place the electrodes on flat, fleshy parts of the arms and legs.
If a limb site is not available, place the electrodes on a perfused area of the stump.
Attach the electrodes to the skin. A good test for firm electrode contact is to slightly tug on the electrode to
check adhesion. If the electrode moves freely, it needs to be changed. If the electrode does not move
easily, a good connection has been obtained.
55
RECORD AN ECG
56
RECORD AN ECG
For accurate V-lead placement, it is important to locate the 4th intercostal space Because patients vary with respect
to body shape, it is difficult to palpate the 1st intercostal space with accuracy. Thus, locate the 2nd intercostal space
by first palpating the little bony prominence called the Angle of Lewis, where the body of the sternum joins the
manubrium. This rise in the sternum identifies where the second rib is attached, and the space just below it is the 2nd
intercostal space. Palpate and count down on the chest until you locate the 4th intercostal space.
Patient Hookup Summary Table
AAMI Lead
Red
IEC
Lead
Red
Electrode
Position
th
On the 4
intercostal space
at the right sternal
border.
Yellow
On the 4
intercostal space
at the left sternal
border.
th
Yellow
Green
Green
Midway between
V2/C2 and V4/C4
electrodes.
th
Blue
Orange
Brown
Black
Violet
Violet
Black
Yellow
White
Red
Red
Green
Green
Black
On the 5
intercostal space
at the left
midclavicular line.
Midway between
V4/C4 and V6/C6
electrodes.
On the left
midaxillary line,
horizontal with
V4/C4 electrode.
On the deltoid,
forearm, or wrist.
On the thigh or
ankle.
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RECORD AN ECG
Patient Demographic Entry
Patient demographic information can be entered before, during or after acquisition. The entered patient ID fields
will remain populated until you acquire the ECG; however, if you turn off the device before exiting the patient
information will be cleared.
In addition to the default patient ID format, Connex Cardio also supports custom ID formats for each group through
use of ELI Link. Refer to the ELI Link Administrator Manual, Part number 9515-166-50-ENG, for instructions on
Custom ID.
STAT ECG
To begin STAT ECG acquisition without patient demographic entry, select the STAT ECG icon
from the
main display to directly start continuous ECG display. Skip to ECG, Acquisition, and Storage on the following
pages. Patient demographics may be entered during ECG collection or after ending ECG acquisition by retrieval of
the STAT ECG from the database.
Start a Resting Exam
Select the Start a Resting Exam icon to open the MWL/Patients window.


When scheduled orders exist, the MWL tab is automatically selected.
When no scheduled orders exist, the Patients tab is automatically selected.
Scheduled Order(s)
1.
When there is an existing order for the patient, highlight the patient in the MWL list.
The Exam Information section on the left side of the display is populated by the previously entered patient
demographics.
2.
Enter any desired exam information on the left panel and select Start Exam.
NOTE: Selection of an unavailable order (e.g. in use at another workstation, deleted, or canceled) will
result in a refresh of the listed orders.
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RECORD AN ECG
No Scheduled Order(s)
When no scheduled orders exist, the Patient tab is automatically selected.
1.
Search for existing patients in the database by entering a name or ID number, and then select the Search
button.
2.
When the patient information is not found, enter any desired patient and exam information on the left panel.
NOTE: If the entered ID number already exists in the database, a warning will appear informing you to
click OK to continue or Cancel to correct the entered demographics.
Enter date of birth by typing MM/DD/YY or DD-MM-YY according to the computer regional settings, or by
clicking on the calendar icon. Select the decade and the year; use the left/right arrows to scroll the year, the
month, and the day to populate the field. Age will be automatically calculated.
Connex Cardio will remember list items such as Indications, Medications, Procedure Type, and Referring
Physician as they are entered. The added items will be available for future selection. Enter text or choose items
from the drop-down menu and then click on the green checkmark to enter. Use the red X to delete the selected
item. When there are multiple entries, items can be moved up or down by using the green arrow keys.
Some fields are not available (grayed) when patient demographics are attached to existing exams in the database
or are ordered by an external system.
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RECORD AN ECG
ECG Acquisition, Printing, and Storage
Once the patient is connected, Connex Cardio continuously captures and displays ECG data. The patient should be
in a supine position and encouraged to relax to ensure that the ECG is free from artifact (noise) due to patient
activity.
Display Overview
Menu Items
Date/Time
Patient
Demographics
Patient Heart
Rate
Patient
Information
ECG
Acquisition
12-lead Real-time
ECG View
Exit
Gain/Speed/Filter
Full Disclosure
ECG / Full
Disclosure Menu
Icons
Timed
Capture
Status
Menu Selections


Click on the settings button in the upper-right area of the display to open the ECG Timed Capture and
WAM Pairing menus.
o
Select ECG Timed Capture to automatically acquire ECGs at preset time intervals.
 Refer to page 39 for instructions
o
Select WAM Pairing to pair the WAM acquisition module.
 Refer to page 39 for instructions
Click the show/hide Full Disclosure ECG section in the lower-left area of the display as desired.
Date/Time
Current date/time according to the computer regional settings is displayed in the upper right-hand corner of the
display.
Real-Time Heart Rate
When a patient is connected to the Connex Cardio, his/her heart rate is displayed in real time. The HR is the
average ventricular rate measured over the patient’s last five beats.
NOTE: If a lead fail occurs or swapped leads are suspected, a red message is visible next to the HR,
indicating the leads off or possibly misplaced, for both limb lead and chest lead fault conditions.
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RECORD AN ECG
Timed Capture Status
Values in the lower-right area of the ECG display indicate the time remaining until the next timed ECG capture and
the total number of 10-second 12-lead ECGs that are currently captured and saved.
Full Disclosure ECG
Single lead ECG or three (3) lead ECG (configurable) is accumulated and displayed along the bottom area of the
display. Twelve (12) leads of ECG are accumulated and stored for up to 60 minutes of full disclosure, which can be
reviewed or printed as a single lead or as acquired ECG.
ECG Display Menu Icons
Icon
Description
Patient Demographics allows editing of existing and entry of new demographics.
ECG button permits the capture of an ECG at any time the patient is connected.
10 appears in the place of ECG when Best 10 capture mode is configured; selects the Best
10 seconds of the full disclosure as the captured ECG.
Done ends and exits the ECG acquisition session.
Full Disclosure Menu Icons
Click within the full disclosure ECG to enable the menu icons for selection.
Icon
Description
Page Up advances the cursor back one page. Page size is
determined by the format, speed, and computer screen size.
Select allows for the selection of the data in the cursor to be
analyzed.
Prints a single lead rhythm page of the Full Disclosure.
Page Down advances the cursor forward one page. Page size is
determined by the format, speed, and computer screen size.
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RECORD AN ECG
Acquire ECGs
Examine the display for artifact or baseline drift. Re-prep and replace electrodes if necessary to obtain satisfactory
waveforms. (See Patient Preparation.)
Please refer to the following troubleshooting guide based on Einthoven’s Triangle:
Artifact
Check Electrode
Lead II and III artifact
Poor LL electrode or left leg tremor
Lead I and II artifact
Poor RA electrode or right arm tremor
Lead I and III artifact
Poor LA electrode or left arm tremor
V Leads
Re-prep site & replace electrode
If a lead fault occurs, square waves appear on the display for that lead and the lead(s) that are faulty will display in
the upper left corner of the screen one at a time. After the leads are reattached correctly at least 10 seconds must be
acquired before an ECG can be captured.
The program monitors the ECG waveform for unusual configurations that could be caused by misplaced (swapped)
electrode positions. If the program detects a high probability of electrode swap, it will display a message like "RA or
LA misplaced?" in the same message area as used for lead fault. Check the electrode connections for any
misplacement.
NOTE: Although the majority of lead wire swaps are correctly detected, some real ECG configurations
may give rise to an inappropriate "misplaced" message, and some real swaps may not be detected due to
patient specific ECG morphologies. The automatic detection helps to prevent lead wire swaps but do not
rely completely on the automatic detection.
Manual ECG Capture
Use the Capture ECG
icon to capture the last 10 seconds of the real time ECG. The captured ECG will
appear on the screen in a format similar to a printout. An average beat can also be viewed if enabled.
The print ECG icon
print automatically.
can be used to print the unconfirmed report; if set in the configuration, the ECG will
ECG acquisition can also be captured by pressing the ECG button
module.
on the WAM or AM12 acquisition
Best 10 Seconds Selection
When the BEST 10
icon is selected, Connex Cardio automatically selects the best quality10 seconds of
acquired ECG available from within the full disclosure ECG buffer.
ECG acquisition can also be captured by pressing the ECG button
on the WAM or AM12 acquisition module
when Best 10 capture has been set up. However, this action will always capture the last 10-seconds of acquired
ECG.
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RECORD AN ECG
Capturing ECGs from Full Disclosure
Click anywhere in the full disclosure display at the bottom of the screen to capture an ECG retrospectively from the
buffer. A green rectangle will appear highlighting the selected 10-seconds of ECG data. You can navigate through
the window with the mouse, or use the page up/down buttons to the right. Use the ECG icon
to capture
the 12-lead ECG. The complete full disclosure data can be printed as a single lead by using the Print Full Disclosure
icon. Waveform data reviewed on the screen can be selected and printed as a single lead of up to 60
minutes of data, depending on the amount of ECG data that has been acquired.
NOTE: ECG size and gain will automatically adjust to allow all data to fit on one page.
NOTE: The full disclosure data cannot be accessed once the acquisition session has ended.
Timed ECG Recording
Connex Cardio automatically acquires ECGs at preset time intervals for future review and processing on the full
disclosure screen. Automatic acquisition is based on the amount of full disclosure time set by the administrator. It
may be set as frequent as every 20 seconds or as infrequently as once per a 60-minute period.
The ECGs captured for the current patient are presented as white rectangles in the full disclosure window. As the
waveform data on the screen refreshes, additional ECGs can be acquired as necessary. Previously acquired data will
be retained in the buffer until the full disclosure buffer has been filled.
See the description of the Menu Item "ECG Timed Capture" on page 39 for instructions how to initiate and set up
timed capture of ECGs. To begin, manually capture an ECG to start timed collection.
NOTE: When the full disclosure buffer duration set by the administrator is reached, Connex Cardio
automatically ends ECG capture and will display the last captured ECG.
Captured ECG Display and Icons
Once captured, the ECG is displayed with global measurements and the VERITAS automatic interpretation. Icon
button selections are located at the right of the captured ECG and actions are described below.
Icon
Description
ID allows editing of existing and entry of new patient information.
Sign the displayed ECG. Icon is only available for those logged in with signing
authority.
Mark the displayed ECG with a Reviewed status. Icon is only available for those logged
in with permission to Edit and Review exams. User is prompted to enter the Reviewer’s
name and select OK. Start a Resting Exam is then displayed.
Save the ECG. ECG is saved with an “Acquired” status. Start a Resting Exam is then
displayed.
Delete the ECG. User is prompted to select Yes or No and is then returned to the realtime ECG display.
Print ECG will send the displayed ECG to the default printer.
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RECORD AN ECG
Median Beats and Median Lead Zoom panels can be shown or hidden by toggling the small arrow buttons
upper-right corners.
in the
The global measurement and interpretation panels can be shown or hidden by toggling the small arrow button
the upper-left corner.
in
Measurement parameters can be changed with a double-click in the Median Lead Zoom area and by dragging the
cursors to the desired positions. Global measurements are updated upon selection of the OK button. Cancel will
undo any changes and revert back to the original locations and global values.
For users with editing permission, the interpretation area can be edited by a single-click in the text area. When the
user begins to type characters, a scrollable pick-list with commonly used statements that begin with, or contain the
characters typed appears allowing quick selection of the desired statement. Refer to interpretation editing details on
page 64.
An undo icon
in the bottom-right corner of the interpretation or measurements area can be selected to revert back
to the original interpretation or measurements respectively when selected before saving the ECG.
NOTE: If no patient age is entered prior to acquiring an ECG, the interpretation algorithm assumes a
40-year old male. The statement “INTERPRETATION BASED ON A DEFAULT AGE OF 40 YEARS” will
be added to the Interpretation text.
NOTE: If a patient age of zero (0) is used the interpretation algorithm will assume a 6-month old infant.
The statement “INTERPRETATION BASED ON A DEFAULT AGE OF 6 MONTHS” will be added to the
interpretation text.
NOTE: Where global measurement values are not available (i.e., rate, interval, axis), text such as ‘- -‘or
‘*’ or similar will display/print for the unavailable value.
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RECORD AN ECG
Printing
If Auto-Print is enabled in the configuration, an ECG is printed following ECG capture, both for manual or timed
capture.
For manual printing, select the Print ECG
button icon. The view on the display is what will print out.
To change the speed, gain, filter, or print format (regardless of the plot format configuration setting) of the acquired
ECG, use a right mouse click over the acquired ECG (see below).
The complete full disclosure data can be printed as a single lead by selecting the Print Full Disclosure
icon. Waveform data reviewed on the screen can be selected and printed as a single lead of up to 60 minutes of data,
depending on the amount of ECG data that has been acquired.
Storage
ECGs are automatically saved to the database upon acquisition. If the current user has permission to review (edit the
interpretation), the Connex Cardio program will automatically restart in Review mode after ending the ECG
acquisition session, with the first ECG captured in the session selected. When multiple timed ECGs are captured,
they can be edited using the exam search functions.
Change Settings
Many settings can be changed by clicking the right mouse button on areas of the display. The context menus may be
different depending on the area selected. Some specific context menus are available for display speed, gain, filter
settings and lead layout in the area of the window where that parameter is displayed. The context menu is also
specific to the display area (e.g. the full disclosure window or the captured ECG window), but where appropriate,
the settings may apply to all windows; for example, if you change the gain through the menu in the full disclosure
window, the gain in the real time window is also changed.
Refer to the next section of this manual for a detailed description of the context menus allowing change.
65
RECORD AN ECG
66
9. CONTEXT MENUS
Context Menu Settings
Many settings can be changed by clicking with the right mouse button on areas of the display. A so-called "context
menu" will be displayed as seen in the examples below. The context menus may be different depending on the area
selected. Some specific context menus are available for display speed, gain, filter settings and lead layout in the area
of the window where that parameter is displayed. The context menu is also specific to the display area (e.g. the full
disclosure window or the captured ECG window), but where appropriate, the settings may apply to all windows; for
example, if you change the gain through the menu in the full disclosure window, the gain in the real time window is
also changed. Some context menus activate specific tools, like measurement calipers.
NOTE: Changes are maintained ONLY for the current sessions. Settings will revert back to the default
settings with the next exam. Refer to the System Settings section in this manual to change the default
settings.
NOTE: Some of the described menus may not be present if they were locked by the administrator in the
Connex Cardio configuration settings.
Context Menus in Captured ECG Context Menus in Real‐time ECG Change Lead Format
 Right mouse click while the cursor is over the captured ECG waveform
 Select Waveforms
 Select Lead Format
 Select from: 3+1, 6, 3+3, 12, or 6+6
NOTE: In the real time display only 6+6 and 12 lead formats are available. It is recommended to choose
a format that allows at least 10 seconds of real time ECG on the screen during acquisition.
3 + 1 Lead Format – Select Lead
 Right mouse click while the cursor is over the captured ECG waveform
 Select Waveforms
 Select Lead Format
 Select: 3+1
 Select from: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, or V6
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CONTEXT MENUS
3 + 3 Lead Format – Select Leads
 Right mouse click while the cursor is over the captured ECG waveform
 Select Waveforms
 Select Lead Format
 Select: 3+3
 Select from: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, or V6
NOTE: 3+3 lead format requires a lead selection for each of the three leads presented.
Full Disclosure Change Lead Format
To change lead format in the full disclosure display:
 Right mouse click while the cursor is over the ECG waveform in the Full Disclosure window
 Select Waveforms
 Select Lead Format
 Select from: single lead by 3, single lead by 6, or 3 lead
NOTE: Single lead by 3 displays three lines of ECG data in the full disclosure buffer. Single lead by 6
displays six lines of ECG data in the full disclosure buffer. Three lead displays two groups of three leads in
the full disclosure buffer. The amount of data displayed is dependent on the size of the display and the ECG
sweep speed selected.
Full Disclosure Single-lead Format – Change Lead
To change the full disclosure lead to a single-lead format:
 Right mouse click while the cursor is over the ECG waveform in the Full Disclosure window
 Select Waveforms
 Select Single Lead Format
 Select from: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, or V6
Full Disclosure Three-lead Format – Change Leads
To change the full disclosure lead to a 3-lead format:
 Right mouse click while the cursor is over the ECG waveform in the Full Disclosure window
 Select Three Lead Format
 Select from: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, or V6
NOTE: Three-lead format requires a lead selection for each of the three leads presented.
Full Disclosure Change Print Lead
To change the full disclosure print lead:
 Right mouse click while the cursor is over the ECG waveform in the Full Disclosure window
 Select Print Lead
 Select from: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, or V6
Change the ECG Presentation Gain
 Right mouse click while the cursor is over the real-time or captured ECG waveform
 Select Waveforms
 Select Gain
 Select from: 2.5 mm/mV, 5 mm/mV, 10mm/mV, or 20 mm/mV
 Gain displays and prints at the bottom of the ECG
NOTE: A shortcut to this menu is available when you right-click on the current gain display of the
window. Different gains are available in the median and full disclosure windows.
Change the ECG Presentation Speed
 Right mouse click while the cursor is over the real-time or captured ECG waveform
68
CONTEXT MENUS





Select Waveforms
Select Speed
Select from: 5 mm/s, 10 mm/s, 25mm/s, or 50 mm/s (real-time only)
Select from: 25mm/s or 50mm/s in the captured ECG waveform
Gain displays and prints at the bottom of the ECG
NOTE: A shortcut to this menu is available when you right-click on the current speed display of the
window. Different speeds are available in the median and full disclosure windows.
Change ECG Low Pass Filter
 Right mouse click while the cursor is over the real-time or captured ECG waveform
 Select Waveforms
 Select Low Pass Filter
 Select from: 0.05 – 40 Hz, 0.05 – 150 Hz, or 0.05 – 300 Hz
WARNING: When the 40 Hz filter is used, the frequency response requirement for diagnostic
ECG equipment cannot be met. The 40 Hz filter significantly reduces high-frequency components of the
ECG and pacemaker spike amplitudes, and is recommended only if high-frequency noise cannot be reduced
by proper procedures.
NOTE: A filter setting lower than 150 Hz will reduce the visibility of fast transients in the ECG like
pacemaker spikes or fast notches. For pediatric ECGs a 300 Hz setting is recommended. Filter settings
apply only to displayed and printed data. Data is stored in unfiltered format.
NOTE: The High Pass filter (or base line filter), indicated by the number "0.05" cannot be changed.
Connex Cardio automatically implements a high performance base line filter that does not distort the ECG
waveform. High Pass filters that do distort the ECG waveform are not available.
Apply Anti-Aliasing to the ECG Display
 Right mouse click while the cursor is over the real-time or captured ECG waveform
 Select Waveforms
 Select Anti-Aliasing
NOTE: Anti aliasing reduces slightly the "staircase" effect due to individual pixels in digital monitors, but
may put a strain on low performance computers.
Change AC Filter on the Real-time ECG
 Right mouse click while the cursor is over the real time ECG waveform
 Select Waveforms
 Select AC Filter
 Select from: None, 50 Hz, or 60 Hz
NOTE: Connex Cardio removes 60 Hz or 50 Hz interference. The setting you select depends on the line
frequency in your country. For example, use the 60 Hz setting in the U.S. If the setting is correct but you
still see mains interference, check the electrode connections, mains interference sources like transformers
or motors close to the patient, and the connection to the safety ground of the computer. Try operating from
battery power if needed.
69
CONTEXT MENUS
Change ECG Presentation To or From Cabrera Format
 Right mouse click while the cursor is on the ECG waveform.
 Select Waveforms
 Select or unselect
Change Median Zoomed Lead in ECG Review Mode
 Right mouse click while the cursor is over the
Median Lead Zoom ECG
 Select Lead
 Select from: I, II, III, aVR, aVL, aVF, V1, V2,
V3, V4, V5, V6 , or All leads (all 12 leads
superimposed)
Switch Between Best Ten and Last 10 Seconds Capture in Real-Time ECG Mode
 Right mouse click while the cursor is over the real-time ECG waveform
 Select Capture
 Select Capture Mode
 Select from: Best 10 or Last 10
NOTE: Defines whether or not the Connex Cardio will automatically capture the 10 seconds ECG with the
lowest noise level from the full disclosure buffer, or the last 10 seconds of data when the ECG button is
selected.
Print Pace Spike Channel
 Right mouse click while the cursor is over the
acquired ECG waveform
 Select Pace Spike on or off
NOTE: When Pacer Spike is selected small tick
marks will appear at the bottom of the ECG printout
where each pacemaker spike was detected by Connex
Cardio.
Display and Print Average RR Interval
 Right mouse click while the cursor is over the acquired ECG waveform
 Select Interpretation
 Select Avg RR on or off
Display and Print QTcB (Bazett)
 Right mouse click while the cursor is over the acquired ECG waveform
 Select Interpretation
 Select QTcB on or off
70
CONTEXT MENUS
Display and Print QTcF (Fridericia)
 Right mouse click while the cursor is over the acquired ECG waveform
 Select Interpretation
 Select QTcF on or off
NOTE: Mortara VERITAS calculates by default the QTc with a linear correction method for average RRinterval similar to the Framingham method. In addition it is possible to display and print the QTc corrected
with the Bazett or Fridericia correction methods.
Print Automatic Interpretation Text
 Right mouse click while the cursor is over the acquired ECG waveform
 Select Interpretation
 Select Print Interpretation on or off
Display and Print Automatic Interpretation Reasons Text
 Right mouse click while the cursor is over the real time ECG waveform
 Select Capture
 Select Interpretation
 Select Reasons Text on or off
NOTE: Reasons statements indicate why a particular interpretive statement was printed. Reasons
statements print enclosed in [square brackets] within the interpretive text if the interpretation option is
turned on. Turning the reasons statement function on or off does not affect the measurements performed or
the interpretive statements selected by the analysis program.
For Example Anteroseptal Infarct [40+ ms Q WAVE IN V1-V4] where “Anteroseptal Infarct” is the
interpretive statement, and “40+ ms Q WAVE IN V1-V4” is the reason statement or explanation as to why
the interpretive statement was printed.
Display Calipers for on-screen measurement


Right mouse click while the cursor is over the acquired ECG waveform
Select Show Calipers on or off
A caliper tool is available in the context menus when you
right click anywhere in the main ECG window, and select
Calipers. Calipers for amplitude and interval
measurements will appear on the waveform.
Hover with the mouse over the caliper area. When you are close to the dotted line, the mouse cursor will change to a
cross and you can now drag the caliper to desired position without changing the distance. When you are close to the
solid line, the mouse cursor will change to a double arrow, and you can drag the single line to the desired position.
When you right click when the arrows or cross is present on the interval calipers, you can select March Out to
repeat the interval caliper over the duration of the recording. You can use any of the vertical solid line to expand or
shrink the calipers, and the horizontal dotted line to drag the whole series to a different position.
71
CONTEXT MENUS
72
10. EXAM SEARCH
Selecting ECG Reports to Review
The Exam Search icon
is available for users that will edit, review, and sign exams. Click on the icon to open
a window allowing you to view the exams according to their status and your role.
The Get Worklist button will filter the list of exams according to the User Preferences for the logged in user.
A search field is available for entry of a patient name or ID number. When you enter one or more alphanumeric
characters, all exams that start with those characters are displayed in a list when the Search button is clicked.
Listed exams can be sorted by clicking any of the column headers.
When a complete last name, first name, or patient ID is entered in the search field and the Search button is clicked,
all matching exams will appear in the list.
Highlight an exam in the list and then click the

Edit button to open the exam for review and editing, or

Report button to open the final report for review and printing, or

More button to display more advanced selections explained below.

Copy Offline button that allows an existing exam to be copied to an external drive using a browser for review
at another Connex Cardio system.

Open Offline button that allows an Connex Cardio system user to open an exam from another system by
browsing to the location of the copied exam.
73
EXAM SEARCH

Transmit button allows the exam results to be sent to the ELI Link destination defined in the system
configuration settings. This selection is only enabled when the selected exam(s) has the associated export status
enabled in the Workflow Config settings.

Reconcile button is used to match an order to an exam that was performed before the order was available, or
to correct information after the exam has been completed with incorrect patient demographics.

Archive button is used to move the exam from the database to an external drive for long-term storage
purposes.

Delete button is used to permanently remove an exam or an order from the system database. The exam is not
recoverable after performing this action.
Button actions are dependent on user permissions. Unavailable buttons will appear grayed.
Advanced Search
For more sophisticated exam list filtering, click on the Advanced button. The identifier selections are relational to
the selected filter and are dependent on your system configuration.
The exam state(s) are selected by checkbox as identifiers. Click the Search button after your filter and identifiers
are selected. Click the Clear button to cancel and remove your entries from the search fields.
When finished, click the Done button to exit the advanced search selections and return to the main Exam Search
window.
74
EXAM SEARCH
Exam Criteria Identifiers
Exam State Identifiers

Acquired
o Checked if equal to


Edited
o Checked if equal to


Reviewed
o Checked if equal to


Signed
o Checked if equal to


Patient ID
o Equal To
o Start With
Last Name
o Equal To
o Start With
First Name
o Equal To
o Start With
Group
o Equal To
o Blank (All)
o Any defined Group this user can access
Date/Time
o Equal To
o Prior To
o Later Than
75
EXAM SEARCH
Edit a Resting ECG Report
When a report is selected from the Exam Search list by a user with review and signing permissions, it is presented
on the screen similar to the one shown below. The Sign and Review button icons are not present for those without
appropriate permissions.
Presence of the Save and Review button icons is dependent on how the administrator has configured workflow in
system settings.
The Patient Information window can be opened and edited with selection of the ID icon button.
If the user agrees with the interpretation statements, the ECG can be saved, marked as reviewed, or signed. After
selection of any of these icon buttons, the user is returned to the Exam Review list.
Patient ID Sign Review Save Print ECG Editing Interpretation
Interpretation statements may be deleted, modified, and new statements added. When adding statements, Connex
Cardio will predict the full statement as characters are typed and will present statements in a pick-list in order of use
frequency. A single-click in the text area allows editing for users with appropriate permissions.
Editing Actions
Description
Down arrow
Moves focus to the statement pick-list
Enter (in statement pick-list)
Adds highlighted statement to the interpretation
Ctrl+L
Deletes the statement text leaving a blank line
76
EXAM SEARCH
Ctrl +L Ctrl+L
Deletes the statement without leaving a blank line
Esc
Closes the statement pick-list
An undo icon
in the bottom-right corner of the interpretation area can be selected to revert back to the
interpretation before any editing changes were made, and when selected before saving the ECG.
NOTE: Each interpretation field line allows up to approximately 65 characters.
Additional characters will wrap to the next line.
NOTE: The interpretation area supports up to 11 lines of text.
Additional lines are allowed but may overwrite the ECG waveform.
Editing Measurements
There are two ways to edit the global measurement values:
1.
Measurement Value Editing
o
Left-click in the value measurement field and enter the
desired value.
o
The undo icon
in the bottom-right corner of the
interpretation area can be selected to revert back to the
measurement values before any editing changes were
made, and when selected before saving the ECG.
2.
Editing Interval measurements using the Median Beat Calipers
o
o
o
o
o
This method can be used for the PR-interval, QRS
duration, and QT duration editing
Double-click in the Median Lead Zoom window.
Measurement calipers are now active in this window.
Drag the calipers to the desired position. Involved and
related interval measurements will be automatically
recalculated.
Select Cancel to leave the editing process without
saving.
Select OK to complete the editing process
NOTE: Interval measurements can also be edited using the interval caliper tool. See next page for details.
Settings
Many settings can be changed using context menus. Right click the mouse on any part of the ECG tracing for the
following settings:
 Change the waveform presentation
 Print pacemaker spikes
 Print interpretation
See the Context Menus section in this manual for a complete description of the context menus.
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EXAM SEARCH
Measurement caliper tool
A caliper tool is available in the context menus when you right click
anywhere in the main ECG window, and select Show Calipers.
Calipers for amplitude and duration measurements will appear on
the waveform.
Hover with the mouse over the caliper area. When you are close to
the dotted line, the mouse cursor will change to a cross and you can
now click and drag the caliper to a desired position without
changing the distance.
When you are close to the vertical line, the mouse cursor will
change to a double arrow, and you can then drag the vertical line to
a desired position.
When you right click when the arrows or cross is present on the interval calipers, a special context menu appears
that allows you to use the displayed caliper value to modify the ECG interval measurements. You can also select
March Out to repeat the interval caliper over the duration of the recording. You can use any of the vertical solid
lines to expand or shrink the marching calipers, and the horizontal dotted line to drag the whole series to a different
position.
Editing Patient Information
Use the ID
button icon at the right to edit patient and exam demographic information
Printing the Report
Use the Print ECG
button icon to the right to print the ECG in the currently displayed format on the default
Windows printer. Note that the state of the exam is not yet updated at this point, so the previous state of the ECG
(e.g. Unconfirmed report) will be printed.
Complete the Editing process



78
Select Save to complete the editing process and return to the Exam Review list.
o ECG is saved with an acquired status if not previously marked as reviewed or signed.
Select Review to mark the ECG status as Reviewed and return to the Exam Review list.
o User is prompted to enter the reviewer’s name.
Select Sign to mark the ECG status as Signed and return to the Exam Review list.
o User is prompted to enter signer’s name or signing authority depending on system configuration.
EXAM SEARCH
Report Print Preview
To open a preview of the ECG report that has been reviewed or signed, select the Report
Exam Search. A preview is generated and the first report page is displayed.
button icon in
Icon Tool Bar
Use the printer icon to open a Windows’ printer dialog and choose defined printers with properties, print range, and
number of copies. To print the report, select OK.
Use the magnifying glass icon to choose Auto to fit the window or a percentage size for display.
Use the page icons to select a single-page or two-page preview.
The number of report pages is shown as xx / xx (displayed page number per total pages). The red arrow keys allow
you to preview the next page or the previous page, as well as move to the last page or the first page.
Use the pink grid icon to toggle the ECG grid background on or off. An X appears when the background is off.
Sections
Use the checkboxes at the left of the display to choose sections for inclusion or exclusion in the final report. Select
the arrows in the bottom left corner of the display to refresh the displayed report after a change is made. The
"Resting" section will print the predefined 12-lead ECG report with demographic information, measurements,
interpretation and signature block.
The "Rhythm" section prints a 12-lead rhythm strip with summarized patient information and no measurements and
interpretation. This section is enabled in the configuration settings by the administrator and may not be present.
Exit the Print Preview
Click on the red X to close the report preview and return to the previous display.
79
EXAM SEARCH
80
3. SYSTEM SETTINGS
Use the System Configuration icon
on the main screen to enter the system configuration menus
The IT and Clinical Administrator can select the System Configuration icon to enter
the Connex Cardio administrative functions. All other users can enter this menu to
access the Export Service Log task only.
A list of administrative task buttons is presented to:

Manage user accounts

Manage personnel lists

Manage Groups

Manage archived exams

View audit trail logs

Export service logs for troubleshooting purposes

Configure system-wide modality settings

Configure ELI Link for DICOM connectivity, XML, and PDF file
exchange

Configure workflow

Unlock exams

Configure patient demographics fields
Manage User Accounts and Personnel
User’s Database
The IT administrator will select Users Database
to create new or delete user accounts, reset user
passwords, assign roles (permissions) and groups
for each user, and assign personnel entries for that
user’s selection. When a single sign-on is used, no
user account and password creation is needed.
Personnel
Personnel is selected to add personnel that will
be available in the Patient Information, Summary,
and the Finalize Exam Update windows. Listed
personnel can be assigned to each user account and
will appear as selections for the logged-in user and
in the appropriate final report fields.
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SYSTEM SETTINGS
New User
Selection of the New button within the Users Database
window will open the New User dialog, similar to the
window to the right.
Tip: It is recommended to complete the
Personnel list before adding Users so they can
be selected as New Users are added.
The name entered in the Display Name field will appear
on the Connex Cardio display when that user logs in.
The login password is entered and repeated.
Roles for this user, Personnel that will populate dropdown lists for this user, and Groups that this user will
have access to are checked.
Tip: Refer to User Role Assignment Table.
Manage/Create Groups
Groups allow the IT administrator to group exams according to user access, reporting preferences (modality
settings) and file exchange preferences. Any user can be assigned to multiple groups. A group definition can be
copied and saved with a new name to create a second group, copying all settings and preferences of the existing
group.
82

Select the Groups button to make changes. Any created group can be copied, renamed and modified.

To create a new group, highlight the group you would like to copy, select New Group, and enter the new
Group Name. A new group will be created with the settings of the highlighted group.

Select the users under the Group User List that may have access to the highlighted group. The Select
All and Deselect All selection can be used to enable or disable all users.
SYSTEM SETTINGS
If you want to rename a group without creating a new one, highlight the group, and enter a Group Name

Select Save Group to save your changes.
The Default group (first in the list) can only be renamed. An unlimited number of new groups can be created and
modified.
Connex Cardio Modality Settings, CFD Configuration, and ELI Link configurations can be uniquely defined for
each individual group.
Groups, with exception of the Default group, can be deleted. All exams present in the database for the deleted group
will be automatically assigned to the default group.
Modality Settings
Modality Settings define all Connex Cardio modality specific default values that do not change on a daily or patientto-patient basis. Most of these settings can be modified within the Connex Cardio modality for a single exam, but
most of these default conditions will rarely need to change. The Modality settings may be "Locked" by the
administrator, meaning that the setting will not be available from within the modality. Use the "Lock" checkbox to
the right of each setting to exclude it from the settings available from within the modality.
Modality settings and file exchange settings are Group dependent. Ensure that the desired group is selected from the
drop-down list before proceeding.
Select the tab you wish to modify and click on Save Changes to apply or Discard Changes to cancel changes
before exiting.
83
SYSTEM SETTINGS
Waveforms Tab
Waveforms
Gain

To change default ECG gain:
 Position the left mouse key over the Gain
 Select Gain
 Select from: 2.5 mm/mV, 5 mm/mV, 10mm/mV, or 20 mm/mV
 Gain displays and prints at the bottom of the ECG
Anti-aliasing
 To apply anti-aliasing to ECG view:
 Select Anti-aliasing
 Choices: On, Off
NOTE: Anti aliasing reduces slightly the "staircase" effect due to individual pixels in digital monitors, but
may put a strain on low performance computers.
Low Pass Filter
 To change default ECG low pass filter:
 Select Low Pass Filter
 Select from: 0.05 – 40 Hz, 0.05 – 150 Hz, or 0.05 – 300 Hz
84
SYSTEM SETTINGS
WARNING: When the 40 Hz filter is used, the frequency response requirement for diagnostic
ECG equipment cannot be met. The 40 Hz filter significantly reduces high-frequency components of the
ECG and pacemaker spike amplitudes, and is recommended only if high-frequency noise cannot be reduced
by proper procedures.
NOTE: A filter setting lower than 150 Hz will reduce the visibility of fast transients in the ECG like
pacemaker spikes or fast notches. For pediatric ECGs a 300 Hz setting is recommended. Filter settings
apply only to displayed and printed data. Data is stored in unfiltered format.
NOTE: The High Pass filter (or base line filter), indicated by the number "0.05" cannot be changed.
Connex Cardio automatically implements a high-performance base line filter that does not distort the ECG
waveform. High Pass filters that do distort the ECG waveform are not available.
AC Filter
 To change default ECG AC filter:
 Select AC Filter
 Select from: None, 50 Hz, or 60 Hz
NOTE: Connex Cardio removes 60 Hz or 50 Hz interference. The setting you select depends on the line
frequency in your country. For example, use the 60 Hz setting in the U.S. If the setting is correct but you
still see mains interference, check the electrode connections, mains interference sources like transformers
or motors close to the patient, and the connection to the safety ground of the computer. Try operating from
battery power if needed.
Cabrera
 To change default ECG to Cabrera:
 Left mouse click on the Cabrera icon
 Choices: On, Off
NOTE: Using the lock indicator to the right of this selection can be enabled to hide this choice from the
technician, permitting only unlocked choices.
Median Zoom
Lead

To change default median ECG lead format display:
 Select Lead
 Choices: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 , All leads (all 12 leads
superimposed)
Speed
 To change default speed on the display:
 Select Speed
 Choices: 100 mm/s, 200 mm/s
Gain

To change default ECG gain:
 Select Gain
 Choices: 10, 20, 40, 80 mm/Mv
85
SYSTEM SETTINGS
Acquire Tab
This Tab is for the default settings of the real time acquisition function of Connex Cardio.
Main
Auto Print
 Select Auto Print
 Choices: On, Off
NOTE: Defines whether or not Connex Cardio will automatically print an unconfirmed ECG after a timed
or manual capture. Manual printout is always possible.
Capture Mode
 Select Capture Mode
 Choices: Best 10 seconds, Last 10 seconds
NOTE: Defines whether or not the Connex Cardio will automatically capture the 10-second ECG with the
lowest noise level from the full disclosure buffer, or the last 10 seconds of data when the ECG button is
selected.
Auto Capture Time (mm:ss)
 Set from: a minimum of 20 seconds up to 59-minutes and 59-seconds.
NOTE: Defines the time intervals in which the ECG will automatically be acquired once "Timed ECG
Capture" is selected.
Real Time
Speed
 Select Speed
 Choices: 5, 10, 25, 50 mm/sec
Lead Format
 Select Lead
 Choices: 12 by 1, 6 by 2
NOTE: In the real time display only 6+6 and 12 lead formats are available. It is recommended to choose
a format that allows at least 10 seconds of real time ECG on the screen during acquisition.
86
SYSTEM SETTINGS
Full Disclosure Tab
This Tab is for the default settings of the full disclosure buffer at the bottom of the acquisition screen.
Speed
 Select Speed
 Choices: 5, 10, 25, 50 mm/s
Lead Format
 Select Lead Format
 Choices: single lead by 3, single lead by 6, or 3 lead
NOTE: Single lead by 3 displays three lines of ECG data in the full disclosure buffer. Single lead by 6
displays six lines of ECG data in the full disclosure buffer. Three lead displays two groups of three leads in
the full disclosure buffer. The amount of data displayed is dependent on the size of the display and the ECG
sweep speed selected.
Single Lead Format - Lead
 Select Single Lead Format
 Choices: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
Three Lead Format - Lead 1, 2 or 3
 Select Three Lead Format
 Choices: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
NOTE: The three-lead format requires a lead selection for each of the three leads presented.
87
SYSTEM SETTINGS
Print Lead
 Select Print Lead
 Choices: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
NOTE: Use Print Lead to select the lead printed on full disclosure printouts.
Buffer Size
 Select Buffer Size
 Choices: 5, 10, 20, 30, 45, 60 minutes
NOTE: Use the Buffer Size to select the total amount of acquisition time permitted in the full disclosure
memory. A warning message will display when the selected time limit has been reached, and acquisition
terminated.
88
SYSTEM SETTINGS
Resting ECG Tab
This Tab is for the default settings of the captured ECG waveform and printouts.
Speed
 Select Speed
 Choices: 25, 50 mm/sec
Lead Format
 Select Lead Format
 Choices: 3+1, 6, 3+3, 12, 6+6
3 + 1 Lead Format - Lead
 Select 3+1 Lead Format
 Choices: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
3 + 3 Lead Format - Lead
 Select 3+3 Lead Format
 Choices: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
NOTE: 3+3 lead format requires a lead selection for each of the three leads presented.
Pace Spike
 Select Pace Spike
 Choices: On, Off
NOTE: When Pace Spike is on, pacemaker spikes will be visible on the waveform display and at the
bottom of the page on captured ECG printouts.
89
SYSTEM SETTINGS
Average RR
 Select Avg. RR
 Choices: On, Off
NOTE: Use this option to display an averaged RR value on the report.
QTcB (Bazett)
 Select QTcB
 Choices: On, Off
QTcF (Fridericia)
 Select QTcF
 Choices: On, Off
NOTE: Mortara VERITAS calculates by default the QTc with a linear correction method for average RRinterval similar to the Framingham method. In addition it is possible to display and print the QTc corrected
with the Bazett or Fridericia correction methods.
Print Interpretation
 Select Print Interpretation
 Choices: On, Off
Reasons Text
 Select Reasons Text
 Choices: On, Off
NOTE: Reasons statements indicate why a particular interpretive statement was printed. Reasons
statements print enclosed in [square brackets] within the interpretive text if the interpretation option is
turned on. Turning the reasons statement function on or off does not affect the measurements performed or
the interpretive statements selected by the analysis program.
For Example:
Anteroseptal Infarct [40+ ms Q WAVE IN V1-V4] where “Anteroseptal Infarct” is the interpretive
statement and “40+ ms Q WAVE IN V1-V4” is the reason statement or explanation as to why the
interpretive statement was included.
90
SYSTEM SETTINGS
CFD Configuration
A long, custom, or short format for displayed items and report contents can be uniquely defined per Group. Select
the CFD Configuration button to display the Custom Format Definition Template drop-down list. Choose the
Long, Custom, or Short template for the selected group and then click the Save Changes button, or the Discard
Changes button to cancel any changes.
The Long format contains all available
demographics.
The Custom format has been created
through use of the ELI Link tool. Refer to
the ELI Link administrator manual, part
number 9515-166-50-ENG, for
information regarding Custom IDs.
Note: Custom IDs are only available
when connected to ELI Link and when an
order is used to populate patient
demographics. If no order, the Short
format is defaulted.
The Short format excludes the patient
history and contact information in the
report summary.
Long CFD
Custom CFD
Short CFD
91
SYSTEM SETTINGS
ELI Link Configuration
Connex Cardio supports the ability to exchange information with DICOM systems, import orders from XML files,
and export PDF and XML results to an external system via ELI Link. Available connectivity options are dependent
on the Connex Cardio system activated features. Refer to the ELI Link Administrator Manual, part number 9515166-50-ENG, for information regarding installation and configuration of the ELI Link gateway service.
When using ELI Link connectivity, check the box to enable communication and enter appropriate information into
the available fields.
The following table describes the available ELI Link configuration settings:
92
SYSTEM SETTINGS
Item
Description
Host Name or IP
Entry field for the network name or IP address of the networked ELI
Link service
Port Number
Site Number
Encryption Key
Entry field for the TCP port number for network communication with
the ELI Link service
Entry of a number will uniquely identify the Connex Cardio that is
communicating with the ELI Link service
Entry field for use of a secret string shared between the ELI Link
service and the Connex Cardio
Enter your desired settings and then click the Save Changes button, or the Discard Changes button to cancel
any changes.
Note: If orders are used with Connex Cardio in XML format and setup through ELI Link, XML order refresh must
be checked in ELI Link or orders will not appear in the worklist in Connex Cardio.
Unlock Exams
Connex Cardio internally tracks transitioning exams preventing the same exam to be processed by two or more
users. When a second user attempts to access an exam in use, a message displays with notification that the exam is
not currently available.
As a measure for recovering locked exams, administrative users can unlock an exam that resides on the same
workstation by selecting Unlock Exams. Highlight the listed exam(s) and click on Unlock.
Manage Archive Storage
The Connex Cardio administrative user will manage storage system disks through selection of Storage System.
Add Archive Location
Select New Archive button to define a path
to the archive directory destination.

Any external disk (e.g. NAS, USB, etc.)
accessible from the Connex Cardio
central database is a candidate for
becoming an archive volume.

The archive path should be defined as a
UNC path such as

\\ServerName\ShareName\Directory\
A Username, Password and Domain
may be entered as needed to add the
new storage disk to the Archive drive
The Refresh Drive List button is available to update the list of
93
SYSTEM SETTINGS
available drives.
listing.
Select Save Changes button to create the
archive location or Discard Changes button to exit this window without saving
changes.
An archive path may also be deleted by highlighting the desired label and selecting the Delete Archive button.
When selected, a prompt asking if you are sure you want to delete the selected archive is presented. Select Yes or
No. All archived ECGs will remain at the destination until they are manually deleted.
94
SYSTEM SETTINGS
Recover Archived Exams
Administrative users can restore exams from the archive location to the Connex Cardio database through selection
of Archive Recovery tab. Once selected, a window will open allowing a search of the Archive Name or the
Archive Label.
To search by Archive Name, a letter or number combination may be entered to show exams that contain the
characters. To search by Archive Label, the first letter of the label can be entered with the Start With description,
or the entire Archive Label can be entered with the Equal To description. Select the Search button when ready.
The Clear button can be selected to clear all search fields. Column headers can be selected to sort listed exams by
that item.
To restore exams, highlight the desired
exam(s) in the list and click on
Recover.
Multiple exams can be restored by
highlighting them followed by a single
Recover button click.
95
SYSTEM SETTINGS
Audit Trail Logs
The Connex Cardio administrative user will select Audit Trail to view the audit trail history. Selections for filter
criteria are available to sort the listing by date, user, workstation, operation, or target (e.g. User, Patient, Exam,
Conclusion, Locked Exams, User and System Settings). One or more filter criteria can be used to find audit trail
information.
Results will display differences by comparing the XML statistics data before and after changes. A legend with
colored highlighting will point to added, removed, changed, and moved information.
All configuration information, user information, patient demographic information, exam demographic information,
textual conclusions, archive operations, and exam download requests are tracked by the audit trail with a date and
time.
Service Logs
All Connex Cardio users have access to Export Service Logs. Selection of the button creates a Win-7 zipped file
that can be sent to the desktop containing a copy of the system logged events.
The file named EMSysLog.xml.gz can be e-mailed to a service representative for troubleshooting purposes.
96
SYSTEM SETTINGS
Configure Workflow
The Connex Cardio exam states are designed to follow typical user workflow. There are five possibilities with
meanings defined below each state:
1.
ORDERED
The resting ECG exam is either scheduled by a user or an external scheduling system has sent an order.
2.
ACQUIRED
The resting ECG exam is completed at the Connex Cardio system and is ready for editing.
3.
EDITED
The resting ECG exam has been analyzed and saved with changes, ready for review by a physician.
Interpretation may be edited at this state.
4.
REVIEWED
The resting ECG exam has been reviewed and confirmed to be accurate by an authorized user (e.g. physician,
fellow, clinician, etc.). Interpretation may be edited at this state.
5.
SIGNED
The exam is reviewed and electronically signed by an authorized user. No further workflow processing is
required. Interpretation may be edited at this state.
Workflow Config
A Legal Signature can be enabled by selecting Yes or
disabled by selecting No. When legal signature is set to Yes,
the user is prompted to enter their login password and ID.
Administrative users can configure the workflow to include
all, or exclude some states through selection of Modality
Status radio buttons.

Select All to enable all five states.

Select No REVIEWED to move the state from EDITED
to SIGNED.

Select No EDITED/REVIEWED to move the state from
ACQUIRED to SIGNED.
Checkboxes under Export Status allow choices for Manual
or Automatic export of the results when the state moves to
Acquired, Edited, Reviewed or Signed. Any combination
may be selected.
A default Print Option with the number of automatic Copies from 1 to 9 can be defined to

Always print automatically when moving to the next state

Never print automatically

Automatically print only If Signed
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SYSTEM SETTINGS
No Legal Signature
When updating the exam to the signed state, the signature area will show the approver’s name with a label of
Approved by: in the final report.
About the Legal Signature
The legal signature requires the user credentials prior to updating a resting ECG exam when changing to a signed
state. When enabled, the user is prompted to authenticate with a user name and password when transitioning to the
signed state. Authentication can be entered when a different user is currently logged in. When the correct
credentials are not entered, the user will be notified with a message that the “Credentials supplied are not valid.”
When the signing physician has been set up as an Attending Physician under Personnel, the printed name will appear
in the Connex Cardio final report on the signature line following the Electronically Signed by: field label.
User Preferences
Select the User Preferences icon to open the window.
Set selections define the default criteria for the Get
Worklist in the Search feature when the particular user is
logged into Connex Cardio.
Set selections can be changed when the user selects the
Advanced search selections.
The user can also change the password in this window
when the system is not set up with a single sign-on.
All users have access to the User Preferences settings but may not have the Search feature available. Those users
will only enter this window to change their own password.
There are three possible choices for the Worklist exam states that can be enabled or disabled by checkboxes. The
choices are dependent on the workflow configuration modality status setting in that Edited or Review may not
appear as selections.
1. Acquired
2. Edited
3. Reviewed
There are three choices for the default time filter for worklists.
1. All
2. Today
3. Last week
The user’s custom lists can also be modified on this page. Some demographic data entry lists also accept free text
which will be automatically added to the list for future use. “My Custom Lists” allows deletion of any list items you
do not wish to use in the future.
The user can change his password on this page, only if “Single Sign On” is not used
When finished, select OK to save changes or Cancel to exit the window without saving changes.
Connex Cardio will present the default settings on any of the workstations that the user logs into.
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SYSTEM SETTINGS
Report Configuration Tool
Connex Cardio final reports can be configured with the practice name prior to using the system. The practice name
is printed at the bottom of each ECG report. In addition, the system can be set up to add or omit a 10 s 12-lead
rhythm strip to each ECG report.
The Report Configuration Tool is a separate program. Click on the Start menu from the Connex Cardio workstation
desktop. Choose "All Programs", "Mortara Modality Manager" followed by "Report Configuration Tool". This will
open a dialog window prompting a Group choice from a drop-down list. Each group that has been defined will have
its own report configuration. Select the group.
Choose the Resting report from the top left. Enter the practice name at the bottom white space. Select the Hide
checkbox if you do not want to print a rhythm strip with each ECG. You can use Report Preview to see a preview
of what will appear on each report.
NOTE: As an individual ECG report is reviewed, rhythm strips can be manually added if "Hide" has been
selected by default.
Select Next and Finish to save the configuration for the selected group. Select another group to configure or Exit
to leave the report configuration tool.
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SYSTEM SETTINGS
User Role Assignment Table
IT Admin
Clinical Admin
Schedule
Procedure
Patient
Hookup
Prepare Report
Schedule / Orders
No
Yes
Yes
No
No
Start a Resting Exam
No
No
No
Yes
No
Exam Search
No
Yes
No
No
Yes
Yes - No
Status Filter
Yes - No Status
Filter
Yes - No
Status Filter
Yes - Filter
Acquired only
Yes - Filter
Acquired and
Edited only
Yes - No
Modality
Settings, CFD
or Report
Settings
Yes - Audit Trail,
Service Logs,
Report Settings,
Modality
Settings and
CFD
Yes - Service
Logs only
Yes - Service
Logs only
Yes - Service Logs
only
Edit
No
No
No
No
Yes - Acquired and
Edited Exams only
Report
No
No
No
No
No
Copy Offline
No
Yes
No
No
No
Open Offline
No
No
No
No
Yes
Export
No
No
No
No
No
Reconcile
No
Yes (Signed
only)
No
No
No
Archive
No
Yes
No
No
No
Delete
No
Yes
No
No
No
Summary Tables
No
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