Quinton Q-Tel RMS User Guide and Service Manual Ver 3.1

USER GUIDE AND SERVICE MANUAL

Q-TEL® RMS 3.1

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Information in this document is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted. CE Mark Declaration The CE marking of conformity indicates that the device having this symbol on its immediate label meets the applicable requirements of the European Medical Device Directive. Trademark Information Cardiac Science, the Shielded Heart logo, Quinton, Q-Tel, and Q-Exchange are trademarks of Cardiac Science Corporation. All other product and company names are trademarks or registered trademarks of their respective companies. Copyright © 2008 Cardiac Science Corporation. All Rights Reserved.

Cardiac Science Corporation 3303 Monte Villa Parkway Bothell, WA 98021, USA (800) 426 0337 (USA and Canada) (425) 402 2000 [email protected] www.cardiacscience.com 2

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MDSS GmbH Schiffgraben 41 D-30175 Hannover Germany Q-Tel® RMS 3.1

Contents

Contents Chapter 1: Safety Indications for Use... 1-1 Safety Alert Descriptions... 1-2 Warnings and Cautions ... 1-3 Electrical safety... 1-6 Improper software use ... 1-8 Operator notes ... 1-9 Symbols and Labels... 1-10 Cleaning and Care ... 1-12 Transmitter Restrictions... 1-12 Channel assignments: 608.48 - 613.52 MHz ... 1-12 Channel assignments: 2400.96 - 2482.56 MHz ... 1-13 EMC Declaration Tables ... 1-14 Electromagnetic emissions ... 1-14 Recommended separation distances... 1-15 Electronic immunity... 1-16

Chapter 2: Introduction User Profile... 2-2 Overview of System ... 2-3 System configuration and settings... 2-4 Software-only configuration ... 2-5 Function ... 2-6 Basic Terms and Operations ... 2-7 Mouse and keyboard operations ... 2-7 Conventions used in this manual... 2-7 Product Features ... 2-8 Product Components... 2-9 Towers and workstations ... 2-9 Telemetry unit ... 2-10 Spectrum analyzer tool ... 2-10 Printers... 2-11 Uninterruptible power supply (UPS)... 2-11 Remote terminal (optional/legacy)... 2-12

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Remote monitor (optional/legacy) ... 2-12 External video extension (optional)... 2-12 Starting the Application ... 2-13 Powering Off the Computer ... 2-14 Help Files... 2-15 Sales and Service ... 2-15

Chapter 3: System Setup Hardware Setup ... 3-1 Transmitter Setup ... 3-2 Configuring the transmitters ... 3-2 X12 Transmitter (legacy)... 3-12 Attaching the patient cable ... 3-13 Battery installation and operation ... 3-13 Patient preparation ... 3-16 Patient hookup... 3-17 Lead fail... 3-17 Lead check... 3-18 X12+ Transmitter advanced features... 3-19 LCD display battery voltage indicator ... 3-20 Display actual battery voltage ... 3-21 Displaying ECG leads ... 3-21

Chapter 4: Patient Information Accessing Patient Information... 4-2 Patient Information... 4-2 Printing a demographics report... 4-4 Patient query report... 4-4 Patient Search Tab ... 4-6 Searching for a patient ... 4-6 Editing existing patients ... 4-7 Adding a new patient... 4-7 Patient search fields ... 4-8 New patient fields... 4-9 Patient Info Tab... 4-10 Insurance Tab ... 4-12 Billing Tab... 4-13 Physician Tab ... 4-14 Emergency Contact Tab ... 4-15 Diagnoses Tab ... 4-16 2

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Medications Tab ... 4-17 Risk Factors Tab ... 4-18 History tab ... 4-18 Family history tab... 4-20 Lipid profile tab ... 4-20 Allergies tab... 4-21 Program Tab... 4-22 Prescription (Rx) Tab ... 4-25 Printing a prescription... 4-25 Modifying a prescription ... 4-26 Prescription (Rx) fields ... 4-27 Alarms Tab ... 4-28 Assessment Tab... 4-29 Clinical assessment ... 4-29 Behavioral assessment ... 4-34 Health assessment... 4-36 Services assessment ... 4-36 Comments ... 4-37 PCP (Patient Care Plan) tab... 4-38 Exercise plan... 4-38 Nutrition plan ... 4-39 Education plan ... 4-39 Psycho-Social plan... 4-40 Expected outcomes... 4-41

Chapter 5: Session Management Accessing Session Management ... 5-2 Admit Tab ... 5-3 Admit tab fields... 5-5 ECG monitoring tile ... 5-6 Session Tab... 5-10 Group view ... 5-10 Individual view... 5-10 Activity management... 5-11 Patient Session Data Tabs ... 5-13 Full Disclosure Tab... 5-18 Comments Tab... 5-20 Entering comments ... 5-20 Comment tab fields... 5-20 Discharge Tab... 5-22 70-00258-01 D

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Discharging a patient... 5-22 Discharge tab fields ... 5-23 Sample Reports ... 5-25

Chapter 6: Charting and Editing Accessing Charting and Editing ... 6-2 Patient Queue ... 6-3 Add to Queue Tab ... 6-4 Session History Tab ... 6-5 Session Tab ... 6-7 Editing past information... 6-7 Editing the prescription ... 6-8 Full Disclosure Tab... 6-9 Comments Tab ... 6-10

Chapter 7: Q-Exchange® Q-Exchange Import/Export folders... 7-2 Import Schema ... 7-3 Data field mapping... 7-3 Modifying billing codes ... 7-4 Import Window... 7-5 Importing Patient Files ... 7-9 Q-Exchange import folders... 7-10 Invalid Imported Files... 7-11 Exporting Patient Data ... 7-12 Exporting patient demographics ... 7-12 Exporting session data from session management ... 7-12 Exporting session data from charting and editing ... 7-13 Q-Exchange viewer... 7-13 Q-Exchange export folders ... 7-14

Chapter 8: Administrative Reports Generating Administrative Reports ... 8-2 Report preview ... 8-4 Administrative Reports... 8-5 Daily Billing ... 8-5 Insurance List ... 8-6 Patient List ... 8-7 Patients for Dates ... 8-8 Physician List ... 8-9 4

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Patient Intake Assessment... 8-10 Patient Care Plan... 8-14 Patient Query... 8-16

Chapter 9: Q-Progress Installing and Configuring ... 9-2 Requirements ... 9-2 System preparation ... 9-2 Installing Q-Progress ... 9-3 Notes for network installations ... 9-5 Windows XP (SP2) Setting Changes... 9-6 Using Q-Progress... 9-10 Using the application ... 9-10 Toolbar options... 9-14 Changing the current Q-Tel RMS database... 9-15 Running Q-Progress on a remote workstation ... 9-15 Configuring the storage directory ... 9-16 Shared network drive... 9-16 Q-Progress Reports ... 9-17 Before you begin ... 9-17 Displaying patient reports ... 9-18 HCFA 700 and 701 reports... 9-18 Discharge Summary Report... 9-21 Discharge Summary Report - Trending... 9-24 Summary Outcomes Report ... 9-28 Critical Comments Summary ... 9-30 Patient Session Summary... 9-31 Duke Activity Status Index... 9-33 Dartmouth Quality of Life Index ... 9-34 Weekly Summary Report ... 9-38 Q-Progress and Microsoft Excel ... 9-39 Excel display notes... 9-40 Q-Progress Export Wizard ... 9-42 Viewing the data in Orion Outcomes... 9-43 Troubleshooting... 9-43 Q-Progress Data exported to Orion Outcomes... 9-44

Chapter 10: Backup/Restore Utility Backup... 10-2 Backup frequency ... 10-2 Tape backup (legacy only) ... 10-2 70-00258-01 D

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Backing up Q-Tel RMS ... 10-3 Restore... 10-5 Messages ... 10-6

Chapter 11: Alarm Subsystem Alarm Types... 11-2 Priority... 11-5 Limits ... 11-7 Record and Store... 11-8 Alarm Notification... 11-9 Visual ... 11-9 Audio ... 11-9 Arrhythmia Detection Modes ... 11-11 Standby ... 11-11 Learn ... 11-11 Normal... 11-12 Alarm Persistence ... 11-13 Silencing Alarms ... 11-16 Example: single session ... 11-16 Example: dual session ... 11-17

Chapter 12: Session Recovery Session Recovery Screen ... 12-2 Recovering a Session ... 12-4

Chapter 13: Configuration Utility Accessing the Configuration Utility ... 13-2 Parameters Tab ... 13-3 Parameter definitions... 13-3 System-defined parameters ... 13-4 Defining custom parameters ... 13-6 Modalities Tab... 13-8 Workload parameters ... 13-9 METS equations ... 13-9 Defining a modality... 13-9 System-defined modalities ... 13-12 METS unit of measure ... 13-14 Programs Tab ... 13-15 Defining a program ... 13-15 Programs tab fields ... 13-19 6

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Alarms Tab ... 13-21 Alarm sound... 13-21 Main volume... 13-21 Medical alarms ... 13-22 Technical alarms... 13-24 List Maintenance Tab ... 13-28 System Setup Tab ... 13-30 Telemetry tab ... 13-30 Trace setup tab ... 13-32 Facility Information tab... 13-34 Auditing Schedule tab ... 13-35 Startup Settings tab ... 13-36 Exchange Tab ... 13-37 Comments Library Tab... 13-38 Session comments ... 13-38 Health assessment comments... 13-38 Exercise goals... 13-39 Nutrition goals ... 13-39 Education classes ... 13-39 Resource Tab ... 13-40 CPT Billing Code Tab... 13-41

Chapter 14: Purge and Archive Purge and Archive Utility... 14-2 Starting the purge and archive utility... 14-3 Select patient information for purge and archive ... 14-3 Patient list ... 14-4 Select patients and programs to purge and archive... 14-5 Final Purge/Archive patient list ... 14-5 Purging data ... 14-7 Archiving data ... 14-8 Error Information List tab ... 14-9 Purge and Archive utility tools... 14-13 Archive Viewer utility ... 14-14 Starting the archive viewer... 14-14 Search archive batch info... 14-14 Selecting patient data to display... 14-15 Display archive data ... 14-15 Show patient and session data... 14-15 User Controls ... 14-16 70-00258-01 D

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Chapter 15: Network Option and Workstation Network Option ... 15-2 Anti-Virus Software ... 15-3 Accessing Patient Data on the Network (Locking) ... 15-4 Locking a record... 15-4 Locking with the Rx feature... 15-5 Accessing Q-Tel RMS Data Remotely ... 15-6 Configuring the Q-Tel RMS ... 15-6 Configuring the remote computer ... 15-7 Additional Features in Patient Information ... 15-9 Refresh List ... 15-9 Patient locking ... 15-9 Additional Features in Session Management ... 15-10 Workstations... 15-11 Turnkey workstation ... 15-11 Software-only workstation ... 15-12 Patient selection... 15-13 Additional Features in Charting and Editing... 15-16 Network Errors ... 15-17 Q-Tel RMS workstation network issue... 15-17 Q-Tel RMS Slave tower network issue ... 15-17 Q-Tel RMS Master tower network issue... 15-18

Chapter 16: Q-Tel RMS Pocket Assistant Navigating with the Q-Tel RMS Pocket Assistant... 16-2 Using the Q-Tel RMS Pocket Assistant... 16-2 Ensuring reliable use... 16-3 Connection Process... 16-4 Patient List View... 16-6 Session Control... 16-8 Session Detail... 16-9 Modality management... 16-9 Modality properties and standard parameters ... 16-11 Adding new parameters to modalities ... 16-12 Modifying existing parameters... 16-13 Removing Parameters from Modalities ... 16-13 Patient Comments ... 16-14 Discharge Settings... 16-15 Password Protection... 16-16 8

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Chapter 17: Troubleshooting Software: Diagnostic/Service Programs and Procedures... 17-2 Strip Recorder... 17-3 Laser Printer ... 17-4 Troubleshooting... 17-4 Report printing errors... 17-4 Speakers ... 17-5 Transmitter Troubleshooting... 17-6 Q-Tel RMS Pocket Assistant Troubleshooting ... 17-7 Encryption ... 17-7 MAC filtering (optional) ... 17-7 Connecting to the Q-Tel RMS Pocket Assistant... 17-7 Valid Q-Tel RMS Pocket Assistant license ... 17-7 Pocket Assistant device re-connection... 17-8 Pocket Assistant user interface display ... 17-8 Error Messages ... 17-9 Configuration errors... 17-11 Network errors ... 17-11

Chapter 18: Maintenance Care and Cleaning ... 18-2 Cleaning Q-Tel RMS components ... 18-2 Cleaning transmitter ECG cables ... 18-3 Transmitter Cleaning and Maintenance... 18-4 Lubricating the battery door (X12 Transmitter only) ... 18-4 Cleaning the electrical connections... 18-5 Disposal of Waste Materials ... 18-7 Printer LED array (OkiData OkiPage only)... 18-8 Cleaning the tape drive ... 18-9 Pocket Assistant ... 18-10 Inspection ... 18-10 Q-Tel RMS Tower hard drive space maintenance... 18-11 Delete temp files... 18-11 Defragment hard disk... 18-12 Assembly/Disassembly Procedures ... 18-13 Replacing computer boards ... 18-13 Installing a new card... 18-14

Appendix A: Specifications 70-00258-01 D

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Q-Tel RMS...A-2 Software-only Workstation Specifications ...A-13 Ventilation clearances ...A-14 Fuse replacement ...A-14 BTU output ...A-14

Appendix B: Antenna Design Amplifiers ...B-2 Antenna Network ...B-3 Power supply requirements...B-3 AN unit specifications ...B-4 Antennas...B-5 Antenna configurations ...B-5 RF cable requirements ...B-7 Network Configurations ...B-8 Single and multi-tower systems...B-8 Extended series networks ...B-10 Branched networks ...B-11 Design Considerations ...B-12 Signal strength...B-12 PC and monitor noise ...B-12 Solving noise problems ...B-13 Coax cabling...B-14

Appendix C: Physician's Guide to Signal Analysis Data Acquisition ... C-2 Filters... C-3 Baseline wander removal... C-3 50/60 Hz line filter... C-3 Muscle artifact and pacer spikes... C-4 Pacer spikes ... C-5 Beat identification accuracy ... C-5 Algorithm Notes ... C-7 Ventricular fibrillation... C-7 Missing QRS ... C-7

Appendix D: Functional Block Diagram Glossary Contact Information 10

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Safety Contents ◆

Indications for Use

1-1

◆

Safety Alert Descriptions

1-2

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Warnings and Cautions

1-3

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Symbols and Labels

1-10

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Cleaning and Care

1-12

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Transmitter Restrictions

1-12

◆

EMC Declaration Tables

1-14

This chapter contains important safety and care information for the Q-Tel RMS system. Periodic inspections and maintenance service are recommended to ensure effective operation. See Maintenance on page 18-1 for more information.

Indications for Use The intended use of the Q-Tel RMS system is the acquisition and transmission of ECG data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting, to a central monitor where it is received, displayed, stored, and analyzed. The system alerts the user to heart rate and arrhythmia in the patient. The intended populations are ambulatory adults where cardiac monitoring is prescribed while undergoing exercise rehabilitation. Patient demographics, exercise prescription, and collected data can be exported to an outcomes management program.

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Safety

Safety Alert Descriptions The symbols shown below identify potential hazard categories. The definition of each category is as follows:

! !

1-2

WARNING! This alert identifies hazards that may cause serious personal injury or death.

Caution This alert identifies hazards that may cause minor personal injury, product damage, or property damage.

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Warnings and Cautions

Warnings and Cautions This section lists general warnings and cautions. Those pertaining to specific functions and procedures are included in the text where appropriate.

! !

WARNING! Restricted use. The Q-Tel RMS System is intended for use in a hospital or clinical setting by trained and authorized personnel who are acting on the orders or under the supervision of a physician. The system is intended as a complement to, not a substitute for, patient observation by health care professionals. WARNING! Use only Cardiac Science Corporation approved equipment. Use of accessories or cables other than those specified, with the exception of accessories or cables sold by Cardiac Science Corporation. as replacement parts for internal components, may result in increased emissions or decreased immunity of the system. Use only Cardiac Science Corporation-approved and specified parts and accessories. Use of other parts can degrade performance and/or safety and may void warranty or contract coverage.

! ! ! ! ! !

WARNING! Restricted use. The Q-Tel RMS system needs special precautions regarding EMC and needs to be installed and put into service according to the guidelines of the EMC declaration tables. WARNING! Audible alarms. Do not connect any devices to the Aux input on the speakers as this may mask an audible alarm. WARNING! Audible alarms are not available during a power failure. During a power outage, the audible alarms will not function; discharge all patients.

WARNING! The Lead Off condition disrupts the alarm function. The arrhythmia alarm detection system must have all leads properly connected to the patient in order to function correctly. If a lead-off condition occurs and the Lead Off alarm displays, reattach the lead as soon as possible. WARNING! RF Interference. Portable and mobile RF communications equipment may affect the Q-Tel RMS system. Observe the recommended separation distances in the EMC declaration tables. WARNING! Improper system performance. The Q-Tel RMS system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe the Q-Tel RMS system to verify normal operation in the configuration in which it will be used.

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Safety

!

! ! ! !

WARNING! Frequency Interference. Other wireless devices operate in the same bandwidth as Q-Tel RMS. For example, 900 MHz cordless telephones and other wireless medical devices operate in the same bandwidth as the 900 MHz Q-Tel RMS system. If used within the vicinity of Q-Tel RMS, these devices may interfere with the signal from the transmitter and can affect the alarm detection/ identification capability. WARNING! Frequency Interference. Microwave ovens operating in the vicinity of a Q-Tel RMS system, particularly the 2.4 GHz system, can interfere with the signal from the transmitter and can affect the alarm detection/ identification capability. Physiotherapy devices that use microwave radiation therapy can cause similar anomalies. Use the Spectrum Analyzer utility to identify interference. WARNING! Review default settings. For optimal patient safety, all operators and clinicians using the system must review the system default settings periodically. WARNING! Explosion hazard. This instrument is not approved for use and must not be operated in the presence of flammable anesthetics. WARNING! Shock hazard. Do not place fluids on top of the unit. Never spill liquid of any kind on this product. Connectors are not fluid proof. Fluid spilled onto the internal parts of the system can create an electrical hazard. If fluid enters the system, turn off the power immediately and call Technical Support. Do not use until the interior has been cleaned and tested. Water tight boots are commercially available, if needed, for your facility’s environment.

! ! !

1-4

WARNING! Shock hazard. Do not spray on liquid cleaners/aerosol cleaners. Only use damp cloth for cleaning.

WARNING! Shock hazard. Do not use this product near water.

WARNING! Possible injury or system damage. Do not place this product on an unstable cart, stand, or table. This product may fall, causing serious damage to the product or to a person nearby.

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Warnings and Cautions

!

WARNING! Visual inspection required. Visually inspect the system periodically to verify functionality. Be aware of and correct any system issues that can affect correct operation and full functionality, such as inoperable hardware, out of adjustment hardware, powered off hardware, or system error messages. Before each use of the equipment, visually check all connector cables and the power receptacle. Make sure all power cables are plugged in securely. Check for worn or damaged plastic coverings, frayed or broken wires, cracked connections, and other signs of damage. Do not operate the equipment if the integrity of these items is in question.

! !

! ! ! !

WARNING! Monitor system data. Q-Tel RMS provides ECG monitoring data. The operator must be aware of the meanings of this data and the patient’s condition to ensure that the patient is not over-exerted during the rehab session. WARNING! Monitor system data. Network slowdowns and system failures may delay or disable the display of ECG waveforms and visual alarms on network-connected Q-Tel RMS Workstations. Alarm volumes should be set sufficiently loud on the Q-Tel RMS Tower to be heard adequately over the entire rehab facility. ECG waveforms displayed on the Workstation that are not being updated should not be relied upon for current patient status. Caution: Restricted use. U. S. Federal Law restricts this device to sale by or on the order of a physician.

Caution: UPS software is not compatible with Q-Tel RMS. Do not install the UPS software that comes with the UPS device.

Caution: Connect only the computer, monitor, and HUB to the UPS. Do not connect any components, other than the computer, monitor, and HUB into the UPS. See the Q-Tel RMS Master Tower block diagram. Caution: System damage. Do not obstruct the air holes on the unit. Improper ventilation and air flow could cause the unit to overheat, resulting in automatic shutdown. Slots and openings in the cabinet and the back or bottom are provided for ventilation. To ensure reliable operation of the product and to protect it from overheating, do not block or cover these openings. Do not place the product on a rug or similar surface that may block ventilation openings. Never place this product near or over a radiator or heat register. Do not place this product in a built-in installation unless proper ventilation is provided.

!

Caution: Possible interference. Other electrical devices used on or near patients connected to this device can cause arrhythmia-like artifact on ECG recordings or displays. Those devices, that induce or pass current through the body, can be checked as a possible source of artifact by turning them off while obtaining the diagnostic ECG waveforms on this device.

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