Q-Stress User Manual Rev L Sept 2020

©2020 Welch Allyn This document contains confidential information that belongs to Welch Allyn, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Welch Allyn, Inc. Welch Allyn, Quinton, Q-Stress, WAM and VERITAS are trademarks or registered trademarks of Welch Allyn, Inc. “SCF” (Source Consistency Filter) is a copyright of Welch Allyn, Inc. SunTech and Tango are registered trademarks of SunTech Medical, Inc. Adobe and Acrobat are registered trademarks of Adobe Systems Inc. Microsoft and Windows are registered trademarks of Microsoft Corporation. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. Software V6.3.X The information in this document is subject to change without notice. PATENT/PATENTS hillrom.com/patents May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. Hillrom Technical Support For information about any Hillrom product, contact Hillrom Technical Support at 1.888.667.8272, [email protected].

9515-205-50-ENG Rev L Revision date 2020-09

901144 CARDIAC STRESS TESTING SYSTEM

and EU IMPORTER Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA

Welch Allyn Limited Navan Business Park, Dublin Road, Navan, Co. Meath C15 AW22 Ireland

Authorized Australian Sponsor Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park NSW 2113 Phone 800 650 083

hillrom.com Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc.

TABLE OF CONTENTS 1.

NOTICES ... 6 MANUFACTURER’S RESPONSIBILITY ...6 RESPONSIBILITY OF THE CUSTOMER ...6 EQUIPMENT IDENTIFICATION ...6 COPYRIGHT AND TRADEMARK NOTICES ...6 OTHER IMPORTANT INFORMATION...7 NOTICE TO EU USERS AND/OR PATIENTS ...7

2.

WARRANTY INFORMATION ... 8 YOUR WELCH ALLYN WARRANTY...8

3.

USER SAFETY INFORMATION ...10 WARNINGS...10 CAUTIONS ...13 NOTE(S) ...14

4.

EQUIPMENT SYMBOLS AND MARKINGS ...16 DEVICE SYMBOL DELINEATION ...16 PACKAGE SYMBOL DELINEATION...18

5.

GENERAL CARE ...19 PRECAUTIONS ...19 INSPECTION ...19 CLEANING AND DISINFECTING ...19 CAUTIONS ...20 DISPOSAL ...20

6.

ELECTROMAGNETIC COMPATIBILITY (EMC) ...22 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS ...23 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY...23 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY...24 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT ...25

7.

INTRODUCTION ...26 MANUAL PURPOSE ...26 AUDIENCE ...26 INDICATIONS FOR USE ...26 SYSTEM DESCRIPTION ...27 MISCELLANEOUS SYSTEM INFORMATION ...28 ABOUT THE Q-STRESS ...28 Q-STRESS ECG ACQUISITION DEVICES AND ACCESSORIES ...30 SUPPORTED TREADMILLS...31 SUPPORTED ERGOMETERS ...31 SUPPORTED AUTOMATIC BLOOD PRESSURE DEVICES ...31 Q-STRESS SOFTWARE INSTALLATION PROCESS...31 FEATURE ACTIVATION ...35 STARTING THE Q-STRESS WORKSTATION ...35 Q-STRESS LOGIN AND MAIN DISPLAY ...35

1

TABLE OF CONTENTS

Q-STRESS ICON DESCRIPTIONS ...37 USER ROLES AND PERMISSIONS ...38 Q-STRESS NETWORK OPERATION IN A DISTRIBUTED CONFIGURATION ...39 Q-STRESS SPECIFICATIONS...41 UTK SPECIFICATIONS ...43 PARTS AND ACCESSORIES ...44 SUPPORT PARTS ...45 8.

MWL/PATIENTS ...46 MWL ...46 PATIENTS ...48

9.

SETUP AND INSTALLATION...49 Q-STRESS SYSTEM SETUP AND COMPONENT INSTALLATION ...49 MEDICAL ISOLATION TRANSFORMER ...51 Q-STRESS FRONT END AND PATIENT CABLE CONNECTION ...52 Q-STRESS FRONT END AND TRIGGER MODULE CONNECTION ...52

10.

USING THE Q-STRESS ...55

DEMONSTRATION MODE ...58 SYSTEM DISPLAY DURING EXERCISE ...59 TOOL BAR: EXAM PHASE BUTTONS ...62 TOOL BAR: FUNCTION KEYS ...63 TILES ...66 PANELS ...69 11.

CONDUCTING A STRESS TEST...73

PATIENT PREPARATION ...73 PATIENT HOOKUP ...73 LEAD IMPEDANCE CHECK...76 START A STRESS TEST ...77 OBSERVATION PHASE ...79 PRE-EXERCISE PHASE ...82 EXERCISE PHASE ...86 RECOVERY PHASE ...87 FINAL REPORT PHASE ...88 QUICK START: SYSTEM SELECTION TO START A STRESS TEST ...89 QUICK START: SYSTEM DISPLAY DURING THE OBSERVATION PHASE ...90 QUICK START: SYSTEM DISPLAY DURING THE PRE-EXERCISE PHASE ...91 QUICK START: SYSTEM DISPLAY DURING EXERCISE PHASE ...92 QUICK START: SYSTEM DISPLAY DURING RECOVERY PHASE ...93 QUICK START: REPORT MANAGER DISPLAY ...94 USING REPORT MANAGER...95 OPEN LEGACY EXAMS ...100 12.

SYSTEM AND USER CONFIGURATION ... 101

ADMINISTRATION TASKS ...101 MANAGE USER ACCOUNTS AND PERSONNEL...101 NEW USER ...102 MANAGE/CREATE GROUPS ...102 MODALITY SETTINGS ...103 FILE EXCHANGE ...109

2

TABLE OF CONTENTS

CFD CONFIGURATION ...110 DICOM AND MWL SETTINGS ...110 UNLOCK EXAMS ...111 MANAGE ARCHIVE STORAGE ...111 AUDIT TRAIL LOGS ...112 SERVICE LOGS ...113 CONFIGURE WORKFLOW ...113 USER PREFERENCES ...114 REPORT SETTINGS ...115 REPORT CONFIGURATION TOOL ...116 13.

EXAM SEARCH ... 118

ADVANCED SEARCH...119 14.

FINAL REPORTS ... 120

PATIENT INFORMATION ...120 EXAM SUMMARY ...120 RATE/BP/WORKLOAD TRENDS ...121 ST LEVEL TRENDS ...121 ST SLOPE TRENDS ...121 WORST CASE AVERAGE ...121 PERIODIC AVERAGE ...121 PEAK AVERAGE ...122 ECG PRINTS ...122 15.

MAINTENANCE AND TROUBLESHOOTING... 123

ROUTINE MAINTENANCE REQUIREMENTS AND CLEANING INSTRUCTIONS ...123 CARE AND HANDLING OF THE OPTIONAL TOUCH MONITOR ...123 CARE AND HANDLING OF THE OPTIONAL ANTIMICROBIAL KEYBOARD AND MOUSE ...123 TROUBLESHOOTING CHART...124 SYSTEM INFORMATION LOG ...126 16.

PROTOCOLS ... 127

STAGE PROTOCOLS ...127 LINEAR RAMP PROTOCOLS ...127 BRUCE PROTOCOLS ...128 17.

TTL/ANALOG OUTPUT ... 143

TTL OUTPUT ...143 ANALOG OUTPUT ...143 TRIGGER MODULE ANALOG AND TTL INTERFACE PORTS ...144 18.

TREADMILL/ERGOMETER HOOKUP ... 145

Q-STRESS TO TREADMILL HOOKUP INSTRUCTIONS WITH SERIAL PORT CONNECTION ...145 Q-STRESS TO ERGOMETER HOOKUP INSTRUCTIONS WITH SERIAL PORT CONNECTION ...145 Q-STRESS TO TREADMILL HOOKUP INSTRUCTIONS WITH USB PORT CONNECTION ...146 Q-STRESS TO ERGOMETER HOOKUP INSTRUCTIONS WITH USB PORT CONNECTION ...146 TREADMILL REMOTE KEYPAD ...147 19.

CONFIGURE PRINTER ... 149

Z200+ THERMAL PRINTER ...149 Z200+ THERMAL PRINTER SPECIFICATIONS ...150

3

TABLE OF CONTENTS

INPUT AND OUTPUT DESCRIPTIONS ...150 SETTING UP THE Z200+ THERMAL PRINTER ...151 MAINTAINING THE Z200+ THERMAL PRINTER ...153 CLEANING THE Z200+ THERMAL PRINTER ...153 TESTING PRINTER OPERATION ...155 POST SERVICE TESTING ...155 LOADING THE THERMAL PRINTER PAPER ...156 TROUBLESHOOTING CHART...159 20.

SUNTECH TANGO+ AND TANGO M2 INTERFACE ... 160

SUNTECH TANGO+ BLOOD PRESSURE (BP) MONITOR AND Q-STRESS CONNECTIONS ...160 TANGO+ BP MONITOR SETUP ...160 SUNTECH TANGO M2 BLOOD PRESSURE (BP) MONITOR AND Q-STRESS CONNECTIONS ...161 TANGO M2 BLOOD PRESSURE (BP) MONITOR SETUP ...162 Q-STRESS SYSTEM SETUP ...162 21.

USER ROLE ASSIGNMENT TABLE ... 163

22.

Q-STRESS DATA EXCHANGE CONFIGURATION ... 165

DATA EXCHANGE INTERFACES ...165 GLOSSARY ...165 NETWORK TOPOLOGIES ...166 DICOM ...168 FILE EXCHANGE ...173 Q-STRESS EXPORT Q-EXCHANGE XML (V3.6) ...174 Q-STRESS DATA IMPORT Q-EXCHANGE XML (V3.6)...178 Q-STRESS EXPORT WELCH ALLYN XML ... 189 Q-STRESS ORDER XML ...198 Q-STRESS EXPORT Q-EXCHANGE XML (V1.0) ...200 23.

Q-STRESS PHYSICIAN’S GUIDE ... 213

Q-STRESS SIGNAL ANALYSIS ...213 DATA ACQUISITION ...213 FULL DISCLOSURE DISPLAY AND STORAGE ...213 FINAL REPORT ...213 FILTERS ...214 BEAT IDENTIFICATION AND ACCURACY ...216 RESTING ECG INTERPRETATION ...216 Q-STRESS CALCULATIONS AND ALGORITHMS ...217

4

TABLE OF FIGURES FIGURE 1 Q-STRESS SYSTEM* ...29 FIGURE 2 Q-STRESS INTERCONNECT DIAGRAM...50 FIGURE 3 MEDICAL ISOLATION TRANSFORMER...51 FIGURE 4 ELECTRODE POSITIONING ... 74 FIGURE 5 Z200+ THERMAL PRINTER ...149 FIGURE 6 USB Z200+ THERMAL PRINTER CONNECTORS ...152 FIGURE 7 INTEGRATED NETWORK Z200+ THERMAL PRINTER CONNECTORS ...152 FIGURE 8 LOADING THE THERMAL PRINTER PAPER ...156 FIGURE 9 INSERT THE PAPER TRAY SPACER ...157 FIGURE 10 INSERT THE PAPER TRAY SPACER ...158

5

1. NOTICES Manufacturer’s Responsibility Welch Allyn, Inc. is responsible for the effects on safety and performance only if: •

Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by Welch Allyn, Inc.

•

The device is used in accordance with the instructions for use.

•

The electrical installation of the relevant room complies with the requirements of appropriate regulations.

Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards.

Equipment Identification Welch Allyn, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced. The Q-Stress product label is applied showing the unique identification numbers along with other important information printed on the label. The serial number format is as follows: YYYWWSSSSSSS YYY = First Y is always 1 followed by two-digit Year of manufacture WW = Week of manufacture SSSSSSS = Sequence number of manufacture The stress system product label and UDI label (when applicable) are applied to the product identification card delivered with the software. AM12Q Module Identification The wired Acquisition Module is identified with a product label on the back of the device and will have its own unique serial number and UDI label applied. Wireless Module Identification The Wireless Acquisition Module (WAM) is identified with a product label on the back of the device and has its own unique serial number and UDI label applied. When the Q-Stress system is configured for the WAM, an external UTK is included with its label showing reference number (REF) and a lot number placed on the UTK.

Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without prior written consent of Welch Allyn, Inc.

6

NOTICES

Other Important Information The information in this document is subject to change without notice. Welch Allyn, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Welch Allyn, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Welch Allyn, Inc. makes no commitment to update or to keep current the information contained in this document.

Notice to EU Users and/or Patients Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

7

2. WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC. (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn 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 Welch Allyn, or if not otherwise noted, for a period of twelve (12) 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 Welch Allyn; 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 Welch Allyn;

f)

Other events outside of Welch Allyn’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 WELCH ALLYN TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Welch Allyn of any alleged defects promptly after discovery thereof within the warranty period. Welch Allyn’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 Welch Allyn’s principal place or any other place as specifically designated by Welch Allyn or an authorized distributor or representative of Welch Allyn, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Welch Allyn is limited and that Welch Allyn does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Welch Allyn is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Welch Allyn should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Welch Allyn shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.

8

WARANTY INFORMATION

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN 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 WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL WELCH ALLYN 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.

9

3. 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 and are not intended to convey actual operating techniques. 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.

The various manufacturers of accessories provide separate user manuals and/or instructions (e.g., display, blood pressure monitor, laser printer, patient cables, and electrodes). Read these instructions well and refer to them for specific functions. It is recommended to keep all instructions together. Refer to these instructions for a list of approved accessories. When in doubt, contact Welch Allyn.

3.

Device (cardiac stress system) captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis; however, the data should not be used as a sole means for determining a patient’s diagnosis.

4.

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 Welch Allyn service for additional training options.

5.

To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a hospital-grade outlet.

6.

The device is supplied with a power isolation transformer that must be used to maintain designed operator and patient isolation from power source. The power isolation transformer must be plugged into a hospital-grade outlet.

7.

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 2601-1, IEC 60601-1, and IEC 60601-2-25. Only use parts and accessories supplied with the device and available through Welch Allyn, Inc.

8.

All signal input and output (I/O) connectors are intended for connection of only those devices complying with IEC 60601-1, or other IEC standards (e.g., IEC 60950), as appropriate to the device. Connecting additional devices to the device may increase chassis and/or patient leakage currents. To maintain operator and patient safety, consideration should be given to the requirements of IEC 60601-1, and leakage currents should be measured to confirm no electric shock hazard exists.

10

USER SAFETY INFORMATION

9.

To avoid potential for electric shock, ensure that approved equipment and accessories are connected to the appropriate ports and that no incompatible equipment has been connected.

10. 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. 11. Conductive parts of the patient cable, electrodes, and associated connections of Type CF applied parts, including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts, including earth ground. 12. Conductive parts of the SunTech® Tango® blood pressure monitor’s optional pulse oximeter (SpO2 sensor used to monitor oxygen saturation) and associated connections of Type BF applied parts should not come into contact with other conductive parts, including earth ground. The pulse oximeter is not defibrillator protected. Refer to the SunTech Tango user instructions for further details. 13. To avoid risk of improper electrical isolation the Tango SpO2 sensor must only be connected to the proper SpO2 extension patient cable or port on the SunTech Tango blood pressure monitor. 14. The personal computer and all peripheral equipment used should be approved to the appropriate safety standard for nonmedical electrical equipment per IEC 60950, or its national variants. 15. If there is a requirement for the personal computer or any peripheral equipment connected to it, including exercise equipment like an ergometer or treadmill to be situated within the patient environment it is the responsibility of the user to ensure the system provides a level of safety that ensures compliance with IEC 60601-1. Non-medical equipment should be powered through a medical grade isolation transformer of sufficient capacity, and a connection to a data network should be made through a medical grade separation device. 16. Position the system in a location where the isolation transformer medical grade power cord plug can be quickly disconnected from the power source should it become necessary to isolate the cardiac stress system from the supply mains. 17. 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. 18. 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. 19. 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. 20. A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. 21. 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. 22. 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. 23. To maintain designed operator and patient safety when the optional network connection is being used, the network cable must be connected to the device through the Ethernet isolator module provided.

11

USER SAFETY INFORMATION

24. Test Q-Stress functions after each Microsoft critical and security update. Instructions for testing the system functions are located in the Q-Stress System Installation Manual, part number 9515-205-60-ENG. 25. To maintain designed operator and patient safety, the Q-Stress Front End, and conductive portions of connected cables must be positioned such that they are inaccessible during normal operation. 26. An additional Multiple Plug Socket Outlet (MPSO) or extension cord shall not be connected to the system. 27. Do not connect any items which are not specified as part of the system. 28. The quality of the signal produced by the thermal writer may be adversely affected by the use of other medical equipment, including but not limited to defibrillators and ultrasound machines. 29. 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. 30.

Do not attempt to clean the device or 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.

31. No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use. 32. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use. 33. 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. 34. When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations. 35. To maintain a safe working environment, the cardiac stress cart including devices and equipment should not exceed 200 kg. 36. 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. 37. The device and IT Network the device is connected to should be securely configured and maintained per the IEC 80001 standard, or an equivalent network security standard or practice. 38. This product complies with relevant electro-magnetic interference, mechanical safety, performance, and biocompatibility standards. However, the product cannot completely eliminate potential patient or user harm from the following: • Harm or device damage associated with electro-magnetic hazards, • Harm from mechanical hazards, • Harm from device, function, or parameter unavailability, • Harm from misuse error, such as inadequate cleaning, and/or

12

USER SAFETY INFORMATION

•

Harm from device exposure to biological triggers that may result in a severe systemic allergic reaction

Cautions 1.

Do not use the device as a method for loading or operating commercially available software. Doing so might affect the performance of the device.

2.

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.

3.

Microsoft Windows compatibility, updates and anti-virus policy: The Q-Stress software has been fully tested with Windows 7 Professional Service Pack 1 and Windows 10 Professional. The Modality Manager 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 Q-Stress functionality, Welch Allyn recommends turning automatic Windows update off, and periodically running it manually. A functional test should be executed after update, which includes conducting an exam, as well as importing an order and exporting results, if activated. Compatibility of Q-Stress with major corporate anti-virus software packages has been verified. Welch Allyn recommends excluding the Q-Stress database folder (normally C:ProgramDataMiPgSqlData 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 Q-Stress application is being used.

5.

It is recommended that all cardiac stress 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 Welch Allyn recommends that institution operating procedures are written to prevent malware to be transmitted into the system from removable media.

7.

Exams that are saved to the local or server database on the hard drive will cause the device to fill over a period of time. These exams must be removed from the database by deleting or archiving prior to causing the device to cease to operate. Periodic checks of the device’s capacity are recommended; a safe minimum capacity is 3 GB. See Exam Search for ways to select exams for deletion or archiving.

8.

The Q-Stress application will display a warning prompting the user to delete exams when the database reaches a threshold at 3.2 GB of available space. Each stress exam is approximately 40 MB in size and only 30 more exams can be started. When the available storage is at 2 GB, no new stress exams can be started.

9.

To avoid risk of unintentionally booting into a USB device, ensure that the Boot Order in BIOS is set with the SATA hard drive listed first in the boot order. Refer to computer manufacturer’s instruction for entering BIOS on startup and configuring Boot Order.

10. The WAM will only work with receiving devices that are equipped with the appropriate option. 11. 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.

13

USER SAFETY INFORMATION

12. The following equipment may cause interference with the WAM RF channel: microwave ovens, diathermy units with LANs (spread spectrum), amateur radios, and government radar. 13. When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations. 14. 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. 15. Be careful to insert the connector block into the appropriate input connector by matching the lead wire labels to the WAM.

Note(s) 1.

Local Administrator permissions are required for software installation, application configuration, and software activation. 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.

Once the Pre-Exercise phase is started, full disclosure data storage begins and will continue for up to 120minutes. It is recommended to Abort the exam and Begin again if waiting in this phase for up to 60-minutes. This prevents unnecessary data storage, however previously stored full disclosure, ECG events, and BP values are not saved when the exam is aborted.

5.

Patient movements may generate excessive noise that may affect the quality of the ECG traces and the proper analysis performed by the device.

6.

Proper patient preparation is important to proper application of ECG electrodes and operation of the device.

7.

The Beat Consistency Filter (BCF) that produces averaged 12-lead ECG printout introduces an additional twosecond delay to the real-time ECG data when enabled.

8.

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.

9.

If the treadmill COM port was originally set to a USB port that was not used, a TREADMILL FAIL message will appear when the Trackmaster (No Sensing) selection is made in the Local Settings menu. When the COM port is set to Treadmill COM Port 1 or 2, which are serial ports, there will be no TREADMILL FAIL message.

10. If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged, display will indicate a lead fault for the lead(s) where the condition is present. 11. As defined by IEC 60601-1 the device is classified as follows: - Class I equipment

14

USER SAFETY INFORMATION

- Type CF, defibrillation-proof applied parts (ECG inputs) - Tango BP monitor type BF, defibrillation-proof applied parts with exception of the optional pulse oximeter that is not defibrillation-proof - Ordinary equipment - Equipment not suitable for use in the presence of a flammable anesthetic mixture - Continuous operation NOTE: From a safety perspective, per IEC 60601-1 and derivative standards/norms, this unit is declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with mains. 12. 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:

-40° C to 65° C (-40° F to 149° F) 8% to 80%, non-condensing

13. Allow the device to stabilize within its intended operating environment for a minimum of two hours prior to use. Refer to the computer and peripheral equipment user manuals for allowable environmental conditions. The allowable environmental conditions for the Q-Stress Front End and Trigger Module are as follows: • •

Ambient temperature: Relative humidity:

10° C to 35° C (50° F to 95° F) 8% to 80%, non-condensing

14. The display of absent waveform while using the WAM wireless acquisition module could be due to the WAM being turned off or having no battery, or the WAM being out of range or experiencing a calibration error. Ensure the WAM is paired correctly and is within recommended proximity of the UTK receiver, and/or power cycle the WAM to re-calibrate. **RF Synch Fail** message will also be displayed. 15. A square wave on the display and rhythm printout could be due to the lead wires not being connected to the patient. 16. The WAM must be paired to the Q-Stress system before operation. 17. 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. 18. The WAM will automatically turn off (LEDs off) if the battery has been severely discharged. 19. The WAM will automatically power off after the exam has ended. 20. The WAM Rhythm Print and 12-Lead ECG buttons are non- functional. 21. The Q-Stress Cardiac Stress Testing System is UL classified:

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4. EQUIPMENT SYMBOLS AND MARKINGS Device Symbol Delineation WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data Follow instructions/directions for use (DFU) -- mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Hillrom for delivery within 7 calendar days. Protective earth Fuse

Defibrillator-proof type CF applied part

Equipment mass including safe working load

Input

ECG A ECG A input connection

ECG B ECG B input connection

Output

TTL Signal Output connection

1

Analog Signal 1 Output connection

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EQUIPMENT SYMBOLS AND MARKINGS

2

3

Analog Signal 2 Output connection

Analog Signal3 Output connection

USB connection

PC USB connection to PC

AC (alternating current)

Printer out of paper or paper error condition Advances paper to the next paper perforation and will reset a paper error condition. When depressed for approximately 7 seconds, will reset the device Do not dispose as unsorted municipal waste. Requires separate handling for waste disposal according to local requirements as per 2012/19/EU.

Indicates compliance to applicable European Union directives

Medical Device

Model Identifier

Reorder Number

Serial Number

Manufacturer Authorized representative in the European Community NOTE: Refer to the manual(s) accompanying the device that pertain to the computer hardware for additional definitions of symbols that may be present

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EQUIPMENT SYMBOLS AND MARKINGS

Package Symbol Delineation

This side up

Fragile

Keep Dry

Keep Away from Heat

Acceptable Temperature Range

Contains Non-spillable Battery

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