Movement and Compressions System (Model RF1400) User Manual UM1400-00-09 Recovery Force, LLC 10022 Lantern Rd.
Approvals The User Manual has been approved by Recovery Force: Role Name Signature/Date Sales & Marketing Jason Bobay Approval in greenlight.guru Quality and Engineering Jeff Schwegman Approval in greenlight.guru Operations Matt Wainscott Approval in greenlight.guru Independent Reviewer Matt Wyatt Approval in greenlight.
Table of Contents A. Introduction .................................................................................................. 3 A.1 How Does the Movement and Compressions System Work? ................... 3 A.2 Intended Use ............................................................................................ 3 A.3 Contraindications ...................................................................................... 4 A.4 Document Definitions, and Abbreviations ................................
EMC Manufacturer Declarations................................................................ 30 E. Troubleshooting ......................................................................................... 33 F. Warranty and Contact Information ............................................................ 35 F.1 Contact Information ................................................................................ 35 F.2. Warranty .................................................................................
A. Introduction A.1 How Does the Movement and Compressions System Work? The Movement and Compressions System works by providing intermittent compressive forces to the legs, increasing the blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation. To perform intermittent compression for DVT Prophylaxis, a single-patient use disposable fabric moisture wicking strap (MAC Strap) is wrapped around a patient’s calf muscle just below the knee.
• As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. • Reduction of edema associated with soft tissue injuries, such as burns, postoperative or post-immobilization edema, or ligament sprains. During use, the system also monitors patient orientation and movement.
CAUTION: Indicates a potentially hazardous situation which, if not avoided, may results in minor or moderate injury, or damage to the equipment or other property. NOTE: Indicates a practice not related to personal injury which if not avoided, may result in property damage. RF1400 - Is a registered trademark of Recovery Force, LLC. DVT - Deep Vein Thrombosis MAC – Movement and Compressions A.
11.This device should not be used adjacent to or stacked upon other devices, or if necessary, to be adjacent or stacked, observation of the proper function in the position used should be verified. a. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation.
19.Do not use with a power supply/charger/strap not recommended by the Manufacturer. This could damage the components of the device. CAUTIONS 1. Movement and Compressions System is latex-free and not made with natural rubber latex. 2. Medical Electrical Equipment needs special precautions regarding EMC. Portable and mobile RF communication equipment can be affected by other medical electrical devices. If you believe interference is occurring, please consult Electromagnetic Compatibility (EMC) section. 3.
1. Compression for 1 second 2. Hold for 1 second 3. Compression release for 2 seconds 4. No compressions for ~ 56 seconds Device will operate for approximately 48 hours on a fully charged battery. Expected service life is 15 days. USER MANUAL P/N UM1400-00-09 12/30/19 Pg 8 Recovery Force 10022 Lantern Rd., Suite 100, Fishers, IN 46037 www.recoveryforceusa.
B. Instructions for Use B.1 Parts Definition MAC Controller MAC Strap MAC Charging Hub Parts List: • Applied Parts: o MAC Controller (Includes Electronics & Battery) Part #: RF1410-00-00 o MAC Strap (2 sizes) Standard Strap: 11” – 17” (27.9cm – 43.2cm) Part #: RF1420-00-00 Extra Large Strap: 17” – 24.5” (43.2cm – 62.
B.2 Unpacking a. Open the cardboard box for both the Controller and Charging Hub. b. Remove the Controller, Charging Hub, and AC Power Cord located in the internal corrugated packaging core. Lift flap and remove items. NOTE: Before using, check Controller and Charging Hub visually for any damage. USER MANUAL P/N UM1400-00-09 12/30/19 Pg 10 Recovery Force 10022 Lantern Rd., Suite 100, Fishers, IN 46037 www.recoveryforceusa.
B.3 Device Operation The Movement and Compressions System comes partially charged and will likely need to be charged before first use. For directions on how to charge the MAC System, see section Charging Movement and Compressions System Device Operation Indicator A user will be able to monitor the activity by an LED light on the Controller. SOLID RED: If the device is powered ON and active, the LED on the Controller shall indicate a solid RED light.
Quick-Start Guide STEP 1 Plug-in the Charging Hub a. The Charging Hub should be plugged into the wall immediately after unboxing to begin charging the batteries that come inside the Charging Hub. b. The Charging Hub has LED lights indicating the charging status of the battery FLASHING GREEN: When a battery is present in the Charging Hub yet not fully charged, the LED shall indicate charging by flashing green.
STEP 2 Insert Battery into Controller a. Once the solid green LED is illuminated on the Charging Hub, remove the battery from the Charging Hub, replace that battery with the battery that came inside the Controller, and insert the fully charged battery from the Charging Hub into the Controller. NOTE: The battery that came inside the Controller will likely need to be charged before being used. STEP 2 Apply Strap a.
STEP 3 Secure Strap a. Feed the end of the strap through the securement loop and secure Velcro. NOTE: Securement Loop should always be placed on inside part of the leg STEP 4 Connect Controller to Strap a. Drop and lock the MAC Controller vertically to the blue mounts on the face of the strap. CAUTION: The Controller must be secured and engaged by both Controller mounts on strap to perform properly. STEP 5 Secure Controller to Strap a.
b. Re-secure Velcro around leg comfortably, but not too snug. STEP 6 Power On Controller a. Once the Controller has successfully been secured to the Strap, power on Controller by pressing the ON / OFF button for ONE second until a SOLID RED light appears. USER MANUAL P/N UM1400-00-09 8/10/20 Pg 15 Recovery Force 10022 Lantern Rd.
NOTE: The Movement and Compressions System will illuminate with a SOLID RED LED when device is turned on and ready to be used. STEP 7 Begin Mechanical Prophylaxis and Mobility Tracking a. Once powered on, the Controller will show a calibration screen followed automatically by the Attach Controller to Strap screen. b.
a. To turn the device OFF, PRESS the ON / OFF button again for THREE seconds until the SOLID RED light no longer appears. b. When not in use, the Controllers should be stored by hanging the securement ring from the Charging Hub. NOTE: The screen on the Controller will read Device Off when device has been turned off properly and also display when the device was last used. Frequently Used Functions Power button ON / OFF for initiating the process to set up intermittent compressions.
The following are example screens offered while using the Movement and Compressions System: BED SCREEN: USER IS CURRENTLY LAYING DOWN This screen example shows the highlighted Bed tab because the user has currently been laying down for 20 consecutive minutes without changing position for more than 1 minute. It also displays that the user has a total of 7 hours and 15 minutes laying down and has spent 80% of the day in the laying down position.
position for more than 1 minute two times. Yesterday’s data is also displayed allowing for the user to compare today’s data vs. yesterday’s. Note: The Upright position includes sitting, standing, and walking. STEPS SCREEN: USER IS CURRENTLY WALKING This screen example shows the highlighted Steps tab because the user is walking. It also displays that the user has a total of 1046 steps in this current session with a total of 1375 steps taken today over the course of 15 minutes.
INACTIVE UPRIGHT SCREEN INACTIVE STEPS SCREEN Note: Once one of the activity tabs has been pressed, the screen will automatically return to the current activity after 10 seconds. Charging Movement and Compressions System CHARGING THE BATTERY: USE ONLY THE CHARGING HUB PROVIDED BY RECOVERY FORCE to charge the MAC System batteries. USER MANUAL P/N UM1400-00-09 12/30/19 Pg 20 Recovery Force 10022 Lantern Rd., Suite 100, Fishers, IN 46037 www.recoveryforceusa.
The Charging Hub is the only way to charge the replaceable batteries of the Movement and Compressions System. Only place the batteries of the Movement and Compressions System in the Charging Hub. NOTE: The batteries for the Movement and Compressions System come partially charged and will likely need to be charged before first use.
B.4 Ending of Treatment Period To end therapy, push the ON / OFF button and hold for 1 second. Remove Controller from the Strap and then remove the Strap from the leg. If the Movement and Compressions System stops working or displays an error message, refer to the Troubleshooting section to resolve the issue. B.5 Safety Features Movement and Compressions System is equipped with overload fuses and will protect against thermal or electrical events. Fuses are not able to be reset by the user.
Contact Recovery Force Customer Service at 1 866.745.7445 to report unexpected operation or events and to receive replacement instructions for any damaged items. If you have any questions or comments about setting up or maintaining this device, call us at 1 866.745.7445 or visit our website www.recoveryforcusa.com/contactus C.
Do not spill any liquids on the device Do not immerse in liquid for any reason. Do not hand or machine wash, dry clean, hand or power wring, iron, tumble or force heat dry. C.
D. Technical Details D.1 Technical Specifications Specifications Model RF1400 Movement and Compressions System Catalog No. RF1400 Class II Max Force 5.5 lbs Voltage 3.6V Lithium rechargeable Battery Battery charger 115V~ 60 Hz Power Consumption 10.44 Wh Fuses Rating 2A Sizing Strap Size Length (in) Height (in) Standard Strap 22 4 XL Strap 29 4 Weight Net Weight including Controller 11 oz Service and Repair The MAC system is not serviceable.
D.2 Product Symbols Definition Symbol Explanation Temperature limitations for storage and/or transport & Operation of the device. Location On Charging Hub and Controller Storage & Transport Temperature: -13°F to 158°F (-25°C to 70°C) Operating Temperature: 41°F and 104°F (5°C to 40°C) Humidity limitations for storage and/or transport & Operation of the device.
UDI Catalog Model number reference On packaging, Controller, Charging Hub, and Strap Unique Device Identifier. On packaging, Controller, Charging Hub, and Strap On packaging, Controller, and Charging Hub This indicates that an object is capable of being recycled, not that the object has been recycled or will be accepted in all recycling collection systems. TYPE BF APPLIED PARTS IP22 IP22 - Protected against solid foreign objects of 12.
Strap not made Not manufactured with natural rubber latex with natural rubber latex Single Patient Use Only This electromechanical device includes printed circuit boards and rechargeable batteries. Do not discard in landfill. Contact local requirements for proper disposal instructions.
Symbols on the Power Adaptor Symbol IP22 Explanation Location Refer to the user manual before proceeding with installation or maintenance This electromechanical device includes printed circuit boards and rechargeable batteries. Do not discard in landfill. Contact local requirements for proper disposal instructions.
D.3 Electromagnetic Interference EMC Manufacturer Declarations Movement and Compressions System - electromagnetic emissions - manufacturer declaration The Movement and Compressions System is intended for use in the electromagnetic environment specified below. The customer or the user of the Movement and Compressions System should assure that it is used in such an environment.
Power frequency (50/60 Hz) magnetic field 3 A/m Complies Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial home use or hospital environment. IEC 61000-4-8 NOTE: U T is the a.c. mains voltage prior to application of the test level! R R Movement and Compressions System - electromagnetic immunity - manufacturer's declaration The Movement and Compressions System is intended for use in the electromagnetic environment specified below.
Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1,2 P 80 MHz to 800 MHz d = 1,2 P 800 MHz to 2,5 GHz d = 2,3 P 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 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
E. Troubleshooting NOTE: Before continuing, check visually for any defects. Error Screen Error Description Battery was removed during operation. Corrective Action Insert charged battery into the MAC System Controller An incorrect date has been set in Press OK and then set correct date on the Controller. Controller Date and/or time is not correct on Controller. Set correct date and time on Controller A critical error has occurred with Power down the Controller. Replace the the Controller.
012: Board Over-Temperature 013: Strap Read/Write Error 014: RTC Error A valid Strap is not connected to Connect the Controller to a MAC System the Controller. Strap. The battery is critically low. Replace the battery with a fully charged battery from the Charging Hub. Date or time of Controller does not match the date or time of the data in the Strap from the previously used Controller. The device is unable to keep the previous data on the strap due to an incorrect date/time.
F. Warranty and Contact Information F.1 Contact Information Recovery Force 10022 Lantern Rd., Suite 100 Fishers, IN 46037 www.recoveryforceusa.com Customer Service Recovery Force 10022 Lantern Rd., Suite 100 Fishers, IN 46037 1 866.745.7445 F.2.
EXCEPT AS PROVIDED ABOVE, RECOVERY FORCE MAKES NO EXPRESS WARRANTIES OR ANY IMPLIED WARRANTIES, INCLUDING THOSE OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE, AND ARE LIMITED IN DURATION AS STATED ABOVE.
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. CAUTION: Please note that changes or modifications of this product is not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with part 15 of the FCC Rules.
