Office Medic QRS for Use with Orbit Smart ECG User Manual Rev K April 2021

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

4 5 6 9

ACCESSORIES ...10 Spirometry Accessories Electrocardiogram Accessories

10 11

OFFICE MEDIC BASICS...12 SYSTEM REQUIREMENTS INSTALLATION BACKING-UP AND RESTORING THE DATABASE NAVIGATION FILE MENU TEST MENU OPTIONS MENU TOOLS MENU HELP MENU

12 12 13 14 15 17 18 20 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. K

ELECTROCARDIOGRAPHY ... 52 ECG CAUTIONS, WARNINGS, AND OTHER INFORMATION 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 55 56 57 59 62 68 69 69

TROUBLESHOOTING AND TIPS. ... 70 SERVICE INFORMATION ...74 DEVICE CARE & MAINTENANCE SERVICE LIMITED WARRANTY

74 75 75

GLOSSARY OF TERMS... 76 DEVICE SPECIFICATIONS ... 79 UNIVERSAL SMARTECG SPECIFICATIONS ORBIT PORTABLE SPIROMETER SPECIFICATIONS

79 80

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

Defibrillator proof type CF equipment Defibrillator proof type CF equipment complying with IEC Publication 60601. CE Mark Indicates this device is in compliance with MDD 93/42/ECC. 2797 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

Important Information Regarding Instruction for Use • • • • • •

Instructions for use are only provided in electronic format and are provided in all Member States of the EU where product is available. Customers can request a hard copy of the instruction for use by contacting VectraCor within 30 days of receiving equipment at no additional cost. Any request for a hard copy of the instruction for use after 30 days upon receiving the equipment can be provided at a cost. Customers can contact VectraCor either by phone or email to request a hard copy of the instruction for use. When a hard copy of the instructions for use are requested, a hard copy will be provided with 7 days of receiving the request. Current and previous revisions of instructions for use are available on www.VectraCor.com.

Warnings • • • • • • • •

Do not use VectraCor Medical Devices in presence of flammable anesthetic mixture. Do not operate VectraCor 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 VectraCor Medical Devices should be evaluated to EN 60950-1, EN60601-1 or equivalent safety standard to maintain the safety of VectraCor Medical Devices. When using a Networked database: verify virus protection software and firewall software are installed and not disabled. Do not use any VectraCor Medical Device on children or vulnerable adults without proper supervision. Ensure patient cabling or tubing is carefully routed on all VectraCor 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.

General Cautions & Warnings

5

•

Do not attempt to insert any VectraCor 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 VectraCor SCP files. Do not use 3rd party applications to review or analyze VectraCor SCP files. Use only VectraCor approved accessories with VectraCor devices.

• • • • •

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.

General Cautions & Warnings

6

Cautions

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

please contact your local municipal waste company for

For VectraCor 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 VectraCorDevices 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! VectraCor 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). Security precautions: • • •

• • • • • • •

User is responsible for protection of the login credentials/ access controls used to access the PC hosting Office Medic and patient database. VectraCor will not be able to give access to any user who has lost their access to their host PC. User is responsible for equipping the PC hosting Office Medic and patient database with necessary protection against external attacks (virus, malware etc.) and protection configuration. VectraCor strongly recommends the user utilize credible antivirus, malware protection, firewall, etc. software on each piece of equipment where patient information is stored. Please keep in mind that VectraCor software will need to be given appropriate permissions to operate properly. User is responsible for creating/maintaining logs of login or Office Medic usage information. User is responsible for patient database including patient demographic information and patient medical data. VectraCor will not receive or maintain any patient identifiable data. User is responsible for scheduled backup of the database to prevent data loss due to unforeseen circumstances. Refer BACKING UP AND RESTORING DATABASE section for instructions. User is responsible for the integrity of Office Medic software and its components residing in the PC. VectraCor does not access, store or modify the patient demographic and medical data stored in the Office Medic database residing in the user’s PC. Use of other equipment that connects to the network may result in unidentified risks to patients, operators or third parties. The User is responsible for identifying, evaluating, and controlling these risks. Changes to the network (including, but no limited to changes in network configuration, connection of additional items, disconnection of items, update of equipment, or upgrade of equipment) may introduce new risks that requires additional analysis.

General Cautions & Warnings

7

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

Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of VectraCor medical devices. RF equipment should only be used no closer than 30 cm (12 inches to any part of VectraCor medical devices. VectraCor 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 VectraCor devices. Verify normal operation if utilizing VectraCor 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

VectraCor 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 VectraCor devices

Voltage Fluctuations/flicker emissions IEC 61000-3-3

Not applicable for VectraCor devices

VectraCor medical devices are suitable for use in all establishments including domestic establishments and those directly connected to the public lowvoltage power supplies buildings used for domestic purposes.

Immunity Test

IEC 60601 Test Level Universal SmartECG Orbit Spirometer

Electrostatic Discharge (ESD) IEC 61000-4-2

±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air

±2 kV, ±4 kV, ±6 kV contact ±2 kV, ±4 kV, ±8 kV air

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

30 A/m

3 A/m

General Cautions & Warnings

Compliance Electromagnetic Environment Guidance



Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%



Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

8

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz



Portable and mobile RF Communications equipment should be used no closer to any part of VectraCor medical devices, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 𝑑𝑑 = 1.2√𝑃𝑃 80 MHz to 800 MHz 𝑑𝑑 = 2.3√𝑃𝑃 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:

General Cautions & Warnings

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NOTE: 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 VectraCor medical devices are used exceeds the applicable RF compliance level above, VectraCor medical devices should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating VectraCor 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 VectraCor medical devices. VectraCor medical devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of VectraCor medical devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and VectraCor 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 (m) 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

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

W

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: 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 VectraCor Medical Devices. • • • • •

Class II Equipment Type CF Equipment. Note: Universal SmartECG is Type CF 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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Accessories Spirometry Accessories Mouth Pieces (Z-5000-2608)

All QRS spirometers use pre-calibrated, disposable mouthpieces. These mouthpieces are individually calibrated during production using the same equipment LDS Hospital uses to validate spirometers against the American Thoracic Society's Recommendations for the Standardization of Spirometry. These pneumotachs are single patient use only. Pressure Tubes (Z-7000-2032)

Pressure tubes connect the pre-calibrated mouthpieces to the QRS spirometers. They are re-usable, but need to be replaced if kinked or if condensation forms inside the tube. Pressure tubes measure 48” long. Nose Clips (724050-00)

QRS, in line with ATS Guidelines, recommends the use of nose-clips when performing a Spirometry test with a QRS spirometer. Calibration Syringe (723000-00)

Accessories

10

QRS sells a three liter Volume Calibration Syringe designed to fit the QRS spirometers. Although QRS spirometers cannot be calibrated in the field, the syringe allows you to check your calibration. According to ATS Guidelines, the volume accuracy of the spirometer must be checked at least daily. If calibration is off, please contact QRS for recalibration of your spirometer.

Electrocardiogram Accessories

Accessories

11

Tab Electrodes

• Gel: Adhesive Gel • Chloride Content: 4% • Substrate: Synthetic Paper or Vinyl • Sensor: Ag/AgCl • Shape/Size: Rectangle, 1” x 7/8” • Adhesive Performance: Usable up to 1 hour • Shelf Life: 2 years, when stored between 10-32°C Wet Gel Electrodes

   

Superior Conductivity Up to 72 hours of continuous use Better Skin Contact Recommended for VectraplexECG System

Snap Electrode Adaptors

• Universal Adapter fits both snap and tab electrodes: Fits 3 mm to 4 mm pin leads • Latch Lock System: Securely locks on electrodes, leads won’t detach • Secure Connection: Reduces false alarms • Re-usable: Adapters can be cleaned/sterilized and re-used

Office Medic Basics

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Office Medic Basics System Requirements Operating System: Microsoft® Windows®: 7 or 10 Free Disk Space: 600MB Internet Requirements: Internet Explorer 6.0 SP1 or later RAM: 4 GB or higher Processor: Dual-core 2 Ghz or higher 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. IT-Network information: • Purpose of networking: Networked databases can be accessed by multiple computers and integrate Office Medic test sessions to an EMR/HER • Required characteristics: Windows NT Client/Server domain. • Required configuration: Windows NT Active Directory • Technical specifications: Microsoft SQL trusted connect string • Intended information flow: The Office Medic software utilizes a Software Developer Kit (SDK) and calls Office Medic to perform tests and return test data. **Recommended system specifications: PC running Windows 7 or 10, Dual core CPU, 4 gigs of RAM, 300 gig HDD or better with an available USB port.

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Installation

Important! Do not connect the medical device to the PC prior to installing the software. The device drivers (step #9) must be installed prior to testing. 1. 2. 3. 4.

Ensure you are logged in with Administrator rights. Remove all VectraCor 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/DVD- ROM drive if it is different from d:. 6. Select Program(s) to be installed I. Office Medic II. Office Medic & VectraplexECG 7. Select a language. ** Language package is available for Office Medic only. VectraplexECG is currently in English only. 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. 8. Follow the on-screen instructions. 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 at VectraCor. An Office Medic shortcut will appear on your desktop when the installation is complete. 9. 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:VectraplexDatabase. 3. Copy the two files VectraplexECG.MDF and VectraplexECG_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:VectraplexDatabase. 3. Open Office Medic. The database should look exactly as it did on the date of the last back-up.

Office Medic Basics

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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 VectraCor Technical Support for instructions on how to hide patient names.

Note: ECG tests with an asterisk symbol are acquired by VectraplexECG. ECG’s with an asterisk symbol will be displayed in VectraplexECG when opened. Note: VectraplexECG only requires account number and gender to create a new patient. Some functions in Office Medic require more information.

Note: If an ECG was first acquired using Office Medic and the user changed the default ECG program from Office Medic to VectraplexECG, the ECG will be displayed in VectraplexECG when opened. Upon closing the ECG in VectraplexECG, the user will be prompted to save the ECG. If the user clicks yes to save the ECG, an ECG test will be created in the Office Medic patient tree under that specific patient. The original ECG from Office Medic will remain. If you do not save, a new file will not be created. When viewing these cases in the future open the appropriate file according to your default ECG program.

Office Medic Basics

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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.

Office Medic Basics

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