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CardiacConnect
Instructions for Use
IFU-10300, Rev. 1
Table of Contents
Descriptive Information ......................................................................................................... 3
What is included with CardiacConnect? ..........................................................................................3
What you need at home: .................................................................................................................3
Who is clinically eligible to use CardiacConnect? .............................................................................3
Intended Use/Indications for Use: ..................................................................................................3
Limitations of Use (Contraindications) ............................................................................................4
Warnings .......................................................................................................................................4
Precautions ....................................................................................................................................5
How will Cardiac Rehabilitation benefit me? ...................................................................................6
How else will a rehab program help me? .........................................................................................6
How will rehabilitation with CardiacConnect benefit me? ...............................................................6
How is my physician part of my cardiac rehabilitation through CardiacConnect? ..............................7
What can I expect during each session? ................................................................................. 7
Operating Information .......................................................................................................... 8
Initial Set Up Instructions .................................................................................................................8
Important things to confirm before your session: ............................................................................8
Session Operation Instructions .........................................................................................................8
Cleaning instructions ......................................................................................................................9
Storage and Maintenance ...............................................................................................................9
Operational Requirements ..................................................................................................... 9
Hardware and Software requirements ............................................................................................9
System Requirements .....................................................................................................................9
Electromagnetic Emissions Compliance ...........................................................................................9
Troubleshooting .................................................................................................................. 10
Issue: Weak Cellular or Wi-Fi Internet Connection ......................................................................... 10
Issue: Auxiliary Device Connection ................................................................................................ 10
Issue: Auxiliary Device Loses Connection ....................................................................................... 11
TM
Rehabilitation System Model 10300
Page 1 of 25
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Table of Contents
Summary of Contents for Romtech CardiacConnect Cardiac 10300
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Page 1: Table Of Contents
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Table of Contents Descriptive Information ......................3 What Is CardiacConnect Cardiac Rehabilitation System model 10300? ..........3 What is included with CardiacConnect? ..................3 What you need at home: .........................3 Who is clinically eligible to use CardiacConnect? ................3 Intended Use/Indications for Use: ....................3 Limitations of Use (Contraindications) ....................4 Warnings ............................4... - Page 2 Electromagnetic Emissions Compliance and Instructions ......16 IEC 60601-1-2 Edition 4.0: 2014 Requirements ................16 FCC Compliant statement ......................22 The Unique Device Identifier label for the ROMTech CardiacConnect is depicted below: ..... 24 Questions and Answers ....................... 24 What should I do if the device isn’t working? ................24 How may I get a paper copy of the Instructions for Use? ...............
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Page 3: What Is Cardiacconnect Tm Cardiac Rehabilitation System Model 10300
Descriptive Information What Is CardiacConnect Cardiac Rehabilitation System model 10300? The ROMTech CardiacConnect Cardiac Rehabilitation System (CardiacConnect) is a cardiac rehabilitation and monitoring system in one. It helps keep an eye on patients while they're exercising for their heart health. It's used during planned workout sessions to make sure you're exercising at the right intensity and for the right amount of time. -
Page 4: Limitations Of Use (Contraindications)
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of ROMTech CardiacConnect including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 5: Precautions
Use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the ROMTech CardiacConnect as replacement parts for internal components, may result in increased emissions or decreased immunity of the ROMTech CardiacConnect WARNING! -
Page 6: How Will Cardiac Rehabilitation Benefit Me
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 • CAUTION Rehabilitation outside approved range, or with extreme resistance, or using/storing the device in extreme heat (above 104degrees F) can cause the device to abruptly shut off. • CAUTION Do not move CardiacConnect once it is set up in your home, or outside supervised rehabilitation sessions or you may experience bodily injury or damage the medical device. -
Page 7: How Is My Physician Part Of My Cardiac Rehabilitation Through Cardiacconnect
After your cardiac event, your physician prescribed CR. ROMTech received your prescription and after the CRS confirms you are healthy enough to receive CR at home, ROMTech will charge the services back to your insurance provider. If you are not healthy enough to receive CR at home, you may still be eligible to receive services at a local facility, but you will need to check with your local physician. -
Page 8: Operating Information
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Operating Information Initial Set Up Instructions The CardiacConnect is delivered to your home and set up by a ROM Technologies Inc. trained technician: A. You will need to provide a stable chair from your home and place its back against a wall, with the front toward the device. -
Page 9: Cleaning Instructions
15% - 90% and atmospheric pressure range of 700 hPa to 1060 hPa. Electromagnetic Emissions Compliance The ROMTech CardiacConnect has been tested and found to comply with the limits for medical devices to IEC 60601-1-2 Edition 3.0:2007 and IEC 60601-1-2 Edition 4.0:2014 standards. These limits are designed to provide reasonable protection against harmful interference in a typical installation. -
Page 10: Troubleshooting
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Troubleshooting Issue: Weak Cellular or Wi-Fi Internet Connection Troubleshooting Steps - When signal strength is weak: A. Click Menu Icon. B. Slide Wi-Fi toggle to switch between Wi-Fi and Cellular as needed. Issue: Auxiliary Device Connection Troubleshooting Steps - When a device will not connect: A. -
Page 11: Issue: Auxiliary Device Loses Connection
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Issue: Auxiliary Device Loses Connection Troubleshooting Steps - When a device loses connection: A. Make sure the device is charged. B. Reboot the device. C. Refer to device IFU for detailed instructions. Symbol Glossary Symbols for Warnings, Precautionary Measures and Notes The following conversations are used in this manual:... -
Page 12: Symbols For Labels
This symbol indicates separate collection for safe disposal. INFORMATION This symbol indicates wireless transmission. INFORMATION This symbol indicates the system is protected against condensation. ROM Technologies, Inc. 101 Silvermine Road, Brookfield, CT 06804 1 – 888 – 457 – 6430 info@romtech.com Page 12 of 25... -
Page 13: Electrical Rating
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Electrical Rating The rating tag for the CardiacConnect is set at 108V – 132 VAC, 2.3A - 1.9A, 50/60Hz. 250 W. The CardiacConnect runs on three main wireless protocols to envision its essential performance: Wireless Modulation Transmitter / Receiver Bandwidth... -
Page 14: Tm Have The Following Ratings
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 The fuses used in the CardiacConnect have the following ratings: Fuse Mfg. Part Related Item Ref Des Fuse Mfg. Description Number Boards 0ZCF0185FF2C Polymeric PTC Resettable 10145-200 Fuse 33V 1.85A Ih Surface rev 2 Mount 2920 (7351 Metric), Concave... -
Page 15: Standards And Compliances
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Standards and Compliances CardiacConnect device and accessories complies with the follow standards: IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 - Electromagnetic Compatibility (EMC) Testing for Medical Devices IEC 60601-2-27 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment... -
Page 16: Electromagnetic Emissions Compliance And Instructions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The ROMTech CardiacConnect is intended for use in the electromagnetic environment specified below. The customer or the user of the ROMTech CardiacConnect should assure that it is used in such an environment. Emissions... - Page 17 Guidance and Manufacturers Declaration – Electromagnetic Immunity The ROMTech CardiacConnect is intended for use in the electromagnetic environment specified below. The customer or the user of the ROMTech CardiacConnect should assure that it is used in such an environment. Immunity Test...
- Page 18 Guidance and Manufacturers Declaration – Electromagnetic Immunity The ROMTech CardiacConnect is intended for use in the electromagnetic environment specified below. The customer or the user of the ROMTech CardiacConnect should assure that it is used in such an environment. Immunity Test...
- Page 19 CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Guidance and Manufacturers Declaration – Electromagnetic Immunity IEC 60601-1-2:2014 + AMD 1:2020 Clause 8.10 Immunity to Proximity Fields from RF wireless communications Equipment. Test Band Service Modulation IMMUNITY Frequency (MHz) TEST (MHz)
- Page 20 Guidance and Manufacturers Declaration – Electromagnetic Immunity The ROMTech CardiacConnect is intended for use in the electromagnetic environment specified below. The customer or the user of the ROMTech CardiacConnect should assure that it is used in such an environment. Immunity...
- Page 21 Guidance and Manufacturers Declaration – Electromagnetic Immunity The ROMTech CardiacConnect is intended for use in the electromagnetic environment specified below. The customer or the user of the ROMTech CardiacConnect should assure that it is used in such an environment. Immunity...
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Page 22: Fcc Compliant Statement
ROMTech CardiacConnect The ROMTech ROMTech CardiacConnect is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the ROMTech CardiacConnect can help prevent electromagnetic interference by maintaining a minimum distance between portable and... - Page 23 CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 Important Information To maintain compliance with FCC regulations, please adhere to the following guidelines: • Proper Usage: Use this medical device only in accordance with the instructions provided in this user guide.
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Page 24: Tm Is Depicted Below
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 The Unique Device Identifier label for the ROMTech CardiacConnect is depicted below: Cybersecurity Update Any time the software on the CardiacConnect updates, you will see the following on the tablet screen: Questions and Answers What should I do if the device isn’t working? -
Page 25: How May I Get A Paper Copy Of The Instructions For Use
CardiacConnect Rehabilitation System Model 10300 Instructions for Use IFU-10300, Rev. 1 How may I get a paper copy of the Instructions for Use? Call 1 – 888 – 457 – 6430 Where can I get more information about the accessories? Detailed information about each accessory (including biocompatibility) may be found within the portal.
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