Related Manuals for Manamed ManaFlexx 2
Summary of Contents for Manamed ManaFlexx 2
- Page 1 Model: MF002-RX Manufactured By: ManaMed, LLC Instructions for Use (Version: V1.1) TD-MF002-RX-BOOK, Rev. 1...
- Page 2 Manufactured By: ManaMed, LLC 2612 Sirius Dr. Denton, TX 76208 Ph: 888-508-0712 www.ManaMed.com...
-
Page 3: Table Of Contents
8. SYMBOL GLOSSARY ..... . 22 For an explanation of symbols, please refer to https://www.manamed.com/glossary/symbol-glossary.pdf 9. ELECTROMAGNETIC COMPATIBILITY ..22 - 27... -
Page 4: Safety Guide
1. SAFETY GUIDE 1.1 Warnings DO NOT USE THIS DEVICE UNDER THESE CONDITIONS... - Page 5 1. SAFETY GUIDE 1.1 Warnings (continued) DO NOT USE ON THESE INDIVIDUALS DO NOT USE THIS DEVICE DURING THESE ACTIVITIES WARNINGS / PRECAUTIONS REGARDING THE ELECTRODE...
-
Page 6: Precautions
1. SAFETY GUIDE 1.2 Precautions... - Page 7 1. SAFETY GUIDE 1.2 Precautions (continued)
-
Page 8: Contraindications
1. SAFETY GUIDE 1.2 Precautions (continued) 1.3 Contraindications... -
Page 9: Adverse Reactions
1. SAFETY GUIDE 1.4 Adverse Reactions 1.5 Intended Use / Indications for Use Mode 2: TENS (Transcutaneous Electrical Nerve Stimulation): Mode 1: PMS/NMES (Neuromuscular Electrical Stimulation):... -
Page 10: Device Description
2. DEVICE DESCRIPTION 2.1 General Description The ManaFlexx 2 delivers electric pulse generated to the user’s body areas through the electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS/NMES. The main unit is egg shape, includes operating... -
Page 11: Device Drawing
2. DEVICE DESCRIPTION 2.2 Device Drawing ManaFlexx 2 Main Unit (Qty: 1) Scan for Fitting Video www.ManaMed.com Electrode (Qty: 1) USB Cable (Qty: 1) Adaptor (Qty: 1) -
Page 12: Device Components
2. DEVICE DESCRIPTION 2.3 Device Components 1. Output Ports 2.3 1 Rear view of the main unit 5. LED Display 4. Intensity Decrease 4. Intensity Increase 2. Mode Switch Power On/Off 2.3 2 Front view of the main unit... -
Page 13: Specifications
2. DEVICE DESCRIPTION 2.4 Specifications Basic Specifications Power Source DC3.7V, 120mAh rechargeable lithium battery Method of Line Current Isolation Type BF Applied Part Patient leakage current Comply with IEC 60601-1 and IEC 60601-2-10 - Normal Condition < 10 μA - Single Fault Condition <... - Page 14 2. DEVICE DESCRIPTION 2.4 Specifications (continued) Treatment Mode Specifications Mode 1 Pulse Duration and Pulse Cycle 1 f=45Hz, T1=22.22ms Note: “T” means Pulse Cycle Mode 1 Pulse Duration and Pulse Cycle 2 f=35Hz, T2=28.57ms Note: “T” means Pulse Cycle Cycle of Mode 1...
- Page 15 2. DEVICE DESCRIPTION 2.4 Specifications (continued) Treatment Mode Specifications Mode 2 Pulse Duration and Pulse Cycle T1=1/f=1/100=10ms Note: “T” means Pulse Cycle Cycle of Mode 2...
-
Page 16: Step 3: Electrode Placement
3. USER INSTRUCTIONS Step 1: Charging Charge the main unit with the included adaptor. It takes about 1.5 hours to charge the main unit from low battery to fully charged. After it is fully charged, the device can be used for 2~2.5 hours. -
Page 17: Step 4: Operation
3. USER INSTRUCTIONS Step 4: Operation (continued) 1. Turn on Briefly press the power button to turn on the device. When booting, the character "1" is displayed, indicating the current mode is Mode 1 (NMES), and the character "0" is displayed after 1 second, indicating that the intensity is 0. -
Page 18: User Instructions
3.3 Electrode Guidelines 1. Only use the electrode supplied by the ManaMed; other electrodes may pose a risk of unsuitable electrical characteristics with your ManaFlexx 2. -
Page 19: Cleaning And Maintenance
9. If you need to re-order the electrode, please contact your medical provider or email ManaMed at support@ManaMed.com 4. CLEANING AND MAINTENANCE 4.1 For Main Unit Dirt and grime on the device should be wiped with a damp cloth. -
Page 20: Storage
4. CLEANING AND MAINTENANCE 4.1 For Electrode (continued) 5. STORAGE... -
Page 21: Troubleshooting
6. TROUBLESHOOTING Problem Possible causes Try this Solution The stimulation Are both two sections Attach both two sections of electrode is not felt or the of electrode to the body and make sure the electrode intensity attached to the body? are not touching each other. -
Page 22: Disposal
For an explanation of symbols, please refer to https://www.manamed.com/glossary/symbol-glossary.pdf 9. ELECTROMAGNETIC COMPATIBILITY The ManaFlexx 2 has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. - Page 23 9. ELECTROMAGNETIC COMPATIBILITY (continued) Manufacturer’s declaration - electromagnetic emissions The ManaFlexx 2 is intended for use in the electromagnetic environments specified below. The customer or the user of the ManaFlexx 2 should assume that it is used in such an environment.
- Page 24 Manufacturer’s declaration - electromagnetic emissions The ManaFlexx 2 is intended for use in the electromagnetic environment specified below. The customer or the user of the ManaFlexx 2 should assure that it is used in such an environment. Electromagnetic Immunity test...
- Page 25 Manufacturer’s declaration - electromagnetic emissions The ManaFlexx 2 is intended for use in the electromagnetic environment specified below. The customer or the user of the ManaFlexx 2 should assure that it is used in such an environment. Immunity test IEC 60601 test...
- Page 26 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured filed strength in the location in which the ManaFlexx 2 is used exceeds the applicable RF compliance level above. The ManaFlexx 2 should be observed to verify normal operation.
- Page 27 9. ELECTROMAGNETIC COMPATIBILITY (continued) Table: Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communications Equipment Immunity test level (V/m) Test Frequency (MHz) Band (MHz) Service Modulation Pulse 380-390 TETRA 400 modulation 18 Hz FM ±5 KHz GMRS 460, FRS deviation 430-470 1KHz sine...
- Page 28 This page left intentionally blank.
- Page 29 This page left intentionally blank.
- Page 30 This page left intentionally blank.
- Page 31 This page left intentionally blank.
- Page 32 Manufactured By: ManaMed, LLC 2612 Sirius Dr. Denton, TX 76208 Ph: 888-508-0712 www.ManaMed.com...
Need help?
Do you have a question about the ManaFlexx 2 and is the answer not in the manual?
Questions and answers