Office Medic QRS for Use with Orbit Smart ECG User Manual Rev F

Table of Contents GENERAL CAUTIONS & WARNINGS ...4 GLOSSARY OF SYMBOLS WARNINGS CAUTIONS ELECTRICAL SAFETY CLASSIFICATIONS

4 5 6 9

OFFICE MEDIC BASICS...10 SYSTEM REQUIREMENTS INSTALLATION BACKING-UP AND RESTORING THE DATABASE NAVIGATION FILE MENU TEST MENU OPTIONS MENU TOOLS MENU HELP MENU

10 10 12 13 14 16 17 19 20

SPIROMETRY ...21 SPIROMETRY CAUTIONS & WARNINGS SPIROMETRY GETTING STARTED PROPER PATIENT PREPARATION PROPER TESTING PROCEDURE EFFORT QUALITY MESSAGES FOR ADULT SUBJECTS TEST SESSION GRADES UNACCEPTABLE SPIROMETRY TESTS REPEATABILITY PERFORMING A SPIROMETRY TEST ABOUT THE SPIROMETRY TEST SESSION WINDOW SPIROMETRY OPTIONS SPIROMETRY TOOLS PREDICTED VALUE EQUATIONS LUNG AGE CALCULATION SPIROMETRY INTERPRETATION

21 22 23 23 24 25 25 25 26 28 29 34 36 47 48

690002-00 Rev. F

ELECTROCARDIOGRAPHY ... 52 ECG CAUTIONS AND WARNINGS ECG GETTING STARTED PERFORMING AN ECG TEST ABOUT THE ACQUISITION WINDOW ECG OPTIONS REVIEWING AN ECG PRINTING AN ECG ECG DEVICE VERIFICATION ECG ANALYSIS PROGRAM

52 54 55 57 59 62 68 69 69

SERVICE INFORMATION ...70 DEVICE CARE & MAINTENANCE SERVICE LIMITED WARRANTY

70 71 71

GLOSSARY OF TERMS... 72 DEVICE SPECIFICATIONS ... 75

UNIVERSAL ECG SPECIFICATIONS ORBIT PORTABLE SPIROMETER SPECIFICATIONS

75 76

General Cautions & Warnings Before conducting tests read the General Caution & Warnings and the specific Cautions & Warnings pertaining to your particular medical device. If you need further assistance see Service.

Glossary of Symbols Attention Consult Accompanying Documents Consult Instructions For Use Consult Accompanying Documents Consult Instructions For Use Consult Accompanying Documents Type BF Equipment Type B equipment with an F-type applied part (patient isolation from electric shock). Defibrillator proof type BF equipment Defibrillator proof type BF equipment complying with IEC Publication 601. CE Mark Indicates this device is in compliance with MDD 93/42/ECC. 0086 is the Notified Body Number. Do not reuse. Class II, Electrical Equipment.

REF S/N

Catalogue or Model Number Serial Number Manufacturer Authorized representative in the European community. Waste Electronic Electrical Equipment (WEEE). Separate collection for waste electrical and electronic equipment.

Rx only

Federal (USA) law restricts this device to sale by or on the order of a physician.

General Cautions & Warnings

4

Latex-Free

Product is Latex-Free Non-Sterile

Batch Code Use By

Upper Limit of Temperature

Warnings • • • • • • • •

•

• • • • •

Do not use QRS Medical Devices in presence of flammable anesthetic mixture. Do not operate QRS Medical Devices in an explosive atmosphere. Use of accessory equipment not complying with EN60601-1 and/or UL2601-1 or equivalent safety standard may lead to a reduced level of safety of the resulting system. Computers and printers used with QRS Medical Devices should be evaluated to EN 60950-1, EN60601-1 or equivalent safety standard to maintain the safety of QRS Medical Devices. Do not use any QRS Medical Device on children or vulnerable adults without proper supervision. Ensure patient cabling or tubing is carefully routed on all QRS Medical Devices to reduce the possibility of patient entanglement or strangulation. All numerical, graphical and interpretive data should be evaluated with respect to the patient's clinical and historical picture. Do not attempt to insert any QRS Medical Device (including patient cables) directly into an electrical outlet.

Restoring the database erases all of the data located in Office Medic and replaces it with the data contained in the back-up file. Data that was acquired after the date of the last back-up will be lost and cannot be recovered. Once deleted, data can only be recovered from the date of your last back-up. Maintain regular back-ups to ensure data is not lost. The computer regulates the battery and will provide a warning message to inform the user that the battery is low in order to prevent data loss. Do not load any other manufacturer’s SCP files. The Office Medic program is designed to work only with QRS Diagnostic SCP files. Do not use 3rd party applications to review or analyze QRS Diagnostic SCP files. Use only QRS approved accessories with QRS devices.

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Cautions Disposal Instructions: Due to the potential presence of hazardous substances in electrical or electronic equipment, DO NOT dispose of QRS Diagnostic medical devices with municipal waste. Improper disposal could have an adverse effect on the environment and human health. For QRS Diagnostic products NOT marked with for proper disposal instructions.

please contact your local municipal waste company

For QRS Diagnostic products MARKED with please contact your local sales representative (from whom you purchased the product) or your local municipal waste company for proper disposal instructions. • Federal (USA) law restricts this device to sale by or on the order of a physician. • All QRS Devices are intended for use by a physician or by trained personnel under a physician's supervision. Read all instructions for use and specifications provided prior to use. Important! QRS Diagnostic medical devices are intended for use in the electromagnetic environment(s) specified below. Users of this equipment should ensure that it is used in such environment(s).

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Attention should be paid to the following EMC information prior to installing or using QRS Diagnostic medical devices. • • • •

Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of QRS Diagnostic medical devices. QRS Diagnostic medical devices have been tested and found to comply with IEC/EN 60601-1-2. Computers, cables and accessories not tested to 60601-1-2 may result in increased emissions or decreased immunity of QRS devices. Verify normal operation if utilizing QRS Diagnostic medical devices adjacent to or stacked with other electrical equipment.

Guidance and manufacturer's declaration - electromagnetic emissions and immunity Emissions Test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

QRS Diagnostic equipment uses RF energy only for its internal function. Therefore, its RF emissions are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Not applicable for QRS Devices other than Universal ECG. Class A for Universal ECG Cable

Voltage Fluctuations/flicker emissions IEC 61000-3-3

Not applicable

QRS Diagnostic medical devices are suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supplies buildings used for domestic purposes.

Immunity Test

IEC 60601 Test Level

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 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of QRS medical devices requires continued operation during power mains interruptions, it is recommended that the computer to be used is powered by an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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 a.c. mains voltage prior to application of the test level

General Cautions & Warnings

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Conducted RF IEC 61000-4-6

3 Vrms 150 KHz to 80 Mz

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF Communications equipment should be used no closer to any part of QRS Diagnostic medical devices, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 80 MHz to 800 MHz 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 range. b Interface may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, 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 QRS medical devices are used exceeds the applicable RF compliance level above, QRS medical devices should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating QRS medical devices. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and QRS Diagnostic medical devices. QRS Diagnostic medical devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of QRS Diagnostic medical devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and QRS Diagnostic medical devices as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

W

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

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 80 MHz and 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 absorption and reflection from structures, objects and people.

General Cautions & Warnings

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Electrical Safety Classifications Note: These classifications currently apply only to QRS Medical Devices. • • • • •

Class II Equipment Type BF Equipment. Note: Universal ECG is Type BF with defibrillator-proof applied part. IPXO - Ordinary Equipment. Continuous Operation. Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

General Cautions & Warnings

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Office Medic Basics System Requirements Microsoft® Windows®: 7, 8, or 10 600MB Free Disk Space: Internet Requirements: Internet Explorer 6.0 SP1 or later RAM: 512 MB or higher Processor: x86 1.0 GHz or x64 1.4 Ghz Screen Resolution: 1024x768 (EKG Requirement) Interface: Available USB port Media: A CD/DVD drive or access to the internet to download the software. Contact Customer care for download instructions and details. Operating System:

**Recommended system specifications: PC running Windows 7, Dual core CPU, 2 gigs of RAM, 300 gig HDD or better with an available USB port.

Installation

Important! Do not connect the medical device to the PC prior to installing the software. The device drivers (step #8) must be installed prior to testing. 1. 2. 3. 4.

Ensure you are logged in with Administrator rights. Remove all QRS devices from the computer. Log out and close all programs. Insert the Office Medic CD-ROM. If the autorun feature on your computer is disabled go to the next instruction. If not follow the on screen prompts.

5. On the lower Windows toolbar select Start | Run or simultaneously press the Windows logo  and R key. Type d:setup.exe in the Open dialog box. Note: substitute the letter of your CD/DVDROM drive if it is different from d:. 6. Select a language. Note: If you need to change the language, you will need to uninstall Office Medic. To do this go to your control panel, click on “Programs and Features” and then find the “Programs” and select “Uninstall a program. Find Office Medic on the list and uninstall. Finally, reinstall Office Medic using the setup program and select the correct language. Any data that was recorded will be preserved because uninstallation doesn’t delete data. 7. Follow the on-screen instructions.

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Note: You will be given a choice to install a local or network database. The Network option requires an Office Medic Network Database formally called IDMS database. To learn more about obtaining a Network database, and networking Office Medic, contact Customer Care. An Office Medic shortcut will appear on your desktop when the installation is complete. 8. Once the installation is complete, connect the medical device to the PC with the CD-ROM still inserted. Follow the software prompts for installing the device driver.

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Backing-up and Restoring the Database Database Back-up Instructions Backing-up your database protects you from losing your patient data should a catastrophic event occur. Regular back-ups of the database should be maintained. Follow the steps below to back-up the database: 1. Close Office Medic. 2. Open folder: C:Program FilesMicrosoft SQL ServerMSSQL.1MSSQLData. 3. Copy the two files OfficeMedic_Data.MDF and OfficeMedic_Log.LDF to a secure location. This is the back-up copy of your Office Medic database. Copy these files as often as needed to maintain a current back-up file.

Database Restore Instructions Warning! Restoring the database erases all of the data located in Office Medic and replaces it with the data contained in the back-up file. Data that was acquired after the date of the last back-up will be lost and cannot be recovered. Follow the steps below to restore the database: 1. Close Office Medic. 2. Copy and paste the two back-up files into the following location: C:Program FilesMicrosoft SQL ServerMSSQL.1MSSQLData. 3. Open Office Medic. The database should look exactly as it did on the date of the last back-up.

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Navigation Select the Office Medic icon to open the software. The initial screen displays the directory of patients, sessions and tests. Contact QRS Technical Support for instructions on how to hide patient names.

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File Menu

New (Ctrl+N) Opens the Patient Information window. Required fields are highlighted by an asterisk.

Note: Smoking-Pack Years is calculated by multiplying the number of cigarette packs smoked per day by the number of years the patient has smoked.

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Open (Ctrl+O) Select a patient, session or test and then select Open to view the selected data. Delete (Ctrl+D) Select a patient, session or test and then select Delete to delete the selected data. Delete All The Delete All option deletes the entire database. Warning! Once deleted, data can only be recovered from the date of your last back-up. Maintain regular back-ups to ensure data is not lost. Print to File Creates an image file (either JPEG, TIFF, or PDF) of an Office Medic report. Highlight the session or test in the patient tree and select this option. Note: The default location for image files is My DocumentsDiagnostic Test DataImage Files. Batch Print The Batch Print option allows for the printing of multiple patient reports. Print Preview Reports can be previewed by selecting the desired session or test and then select File | Print Preview. Print (Ctrl+P) Select a patient, session or test and select File | Print to print a report. Refresh Patient Tree (F5) Select to refresh the patient database. Database Connection... Select to switch between local and network databases. Exit Exits the Office Medic program.

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Test Menu Select a patient and then select the desired test from the Test menu to begin testing.

For details on spirometry testing see Performing a Spirometry Test For details on ECG testing see Performing an ECG Test

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Options Menu Select Options to change program settings.

General Options

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Units Select Imperial or Metric. Export File Creates tab delimited ASCII text files: Session.txt, SpTest.txt, SpCalibr.txt, OxiSess.txt and OxiTest.txt. The Export Flow/Volume Points feature creates two files called SpGraph.txt and SpCalGr.txt. Image File Directory: Select the browse button to change the default path where image files are saved. Allow remote handhelds to initiate unattended synchronization sessions: MedicSync will launch automatically on the host computer and execute the existing handheld synchronization profile automatically within 30 seconds. If a conflict occurs, the handheld database will always overwrite the host computer database as no manual conflict resolution is available when using unattended synchronization. Note: If the host computer is set to delete data from the remote, then data will be deleted from the remote during an automatic synchronization.

For details on changing the spirometry options see Spirometry Options For details on changing the ECG options see ECG Options

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Tools Menu

General Tools

MedicSync MedicSync synchronizes data between QRS patient databases. For information about unattended remote synchronization with your Pocket PC see the General Options section. MedicSync is designed to work with Microsoft® ActiveSync® version 3.5 or higher. Before using MedicSync you should upgrade ActiveSync (if necessary). ActiveSync is a free download from the Microsoft website. Important! You should close all other applications on your PC before beginning a MedicSync session. For details on the spirometry tools see Spirometry Tools

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Help Menu

User’s Manual Opens the Office Medic User Manual. ECG Physician’s Guide Opens the Physician’s Guide for the ECG interpretation algorithm. About QRS Provides information for contacting QRS Diagnostic. About Office Medic Displays the version of Office Medic and statistics about any connected device.

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