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Manual | Users Manual | 401.21 KiB | July 06 2021 / January 03 2022 | delayed release | ||
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internal photos | Internal Photos | 1.77 MiB | July 06 2021 / January 03 2022 | delayed release | ||
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external photos | External Photos | 524.50 KiB | July 06 2021 / January 03 2022 | delayed release | ||
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Label | ID Label/Location Info | 105.87 KiB | July 06 2021 | |||
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Applicant cover letter | Cover Letter(s) | 586.31 KiB | July 06 2021 | |||
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Confidentiality Letter | Cover Letter(s) | 612.87 KiB | July 06 2021 | |||
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MPE Report | RF Exposure Info | 405.71 KiB | July 06 2021 | |||
1 | Operational Description | Operational Description | July 06 2021 | confidential | ||||
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Power of Attorney Letter | Cover Letter(s) | 383.36 KiB | July 06 2021 | |||
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Test Report | Test Report | 4.18 MiB | July 06 2021 | |||
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Test setup photo | Test Setup Photos | 585.94 KiB | July 06 2021 / January 03 2022 | delayed release |
1 | Manual | Users Manual | 401.21 KiB | July 06 2021 / January 03 2022 | delayed release |
Normatec 3 Operating Instructions EN WARNINGS Read the entire instruction manual before using the Normatec 3 System. WARNING! No modification of this equipment is allowed. during use:
Stop the control unit by pressing the power button. Disconnect the hose from either the control unit or the attachments. Remove the attachments from your limbs. Promptly consult your licensed healthcare practitioner, as required. WARNING! If you experience severe pain, any unusual symptoms, or want to remove the attachments in an emergency CAUTION!
Do not attempt to take apart the system. The system has no user-serviceable parts. When service or repairs are required, please contact customer service at +1.949.565.4994. Do not remove or attempt to disassemble the battery door from the enclosure. Only use the power supply provided with the system. Using a different power supply may cause the system to operate incorrectly. swimming pool. To avoid risk of electric shock, do not use the system near water, such as near a bathtub, kitchen sink, laundry tub, or To avoid damage and risk of electric shock, never spill liquid of any kind on the system. Do not place the system, power supply, or any accessories where they could be damaged, present a fall hazard, or become an obstruction to others. Keep the open ports of the control unit, hose interconnect, and power inlet free of debris. If the power supply is damaged, the control unit is dropped or damaged, liquid is spilled on the system, or the system does not operate normally when the operating instructions are followed, turn the system off by pushing the control units power button and then unplugging the system from the wall outlet. Contact customer service at Do not puncture or otherwise damage the attachments (legs, arms, hips, or custom attachments) since this may cause
+1.949.565.4994 for assistance. the system to operate incorrectly. 2 To avoid risk of strangulation, do not leave a baby or child unattended with the power supply or hose. Choking hazard, small parts. Keep away from small children. 3 Do not leave the system, power supply, or any accessories where they could be damaged by children, pets, pests, or liquids. If you suspect your control unit is damaged, contact customer service at +1.949.565.4994 for assistance. Do not allow lint or dust to accumulate on the control unit or the hose interconnects. If lint or dust accumulates, wipe down the system with a dry cloth before use. The IP21 classification means the control unit is protected against the ingress of vertically dripping water and the hazardous parts are protected against access to objects equal to or larger than 12.5 mm (1/2). The expected service life of the system and the integrated battery is 3 years. Do not walk while wearing the attachments. The attachments are designed to be used by only one person at a time. Do not hold the unit by the hose. Consult your physician before using this product if you are under the care of a physician or have a contraindication requiring the use of any medical control unit. Consult your physician before using this product if you are experiencing inflammation, an infection, pain of unknown origin, bleeding (internal or external) at or near the site of application, or if you have a wound at or near the site of application. Consult your physician before using this product on sensitive skin. Consult your physician before using this product if you have any of the following conditions:
Acute pulmonary edema Acute thrombophlebitis Acute congestive cardiac failure Acute infections Deep vein thrombosis (DVT) Episodes of pulmonary embolism Wounds, lesions, or tumors at or near the site of application Where increased venous and lymphatic return is undesirable Bone fractures or dislocations at or near the site of application Do not use the Normatec 3 System air output or hose to direct pressurized air toward your eyes, nose, mouth, or ears. Doing so may lead to serious injury. Use by unconscious or incapacitated persons may be dangerous without supervision. Make sure the power inlet on the control unit is easily accessible at all times in order to disconnect power if required. The Normatec 3 control unit contains a Li-ion battery and, if the control unit is discarded, the control unit needs to be 4 disposed of in accordance with local regulations. Save this manual for future reference. LABELS The following labels and symbols appear on the control unit, garments, and/or packaging. Symbol Description Location IP21 Degree of protection against ingress of water On base of control unit Read instructions before use On base of control unit and attachment tag Level of protection type BF patient equipment (Leg, Arm, Hip Attachment) On base of control unit Double insulation Direct current Alternating current Manufacturers name and address Date of manufacture Fragile, handle with care Keep dry This side up Keep away from sunlight 93 %R H 10 %R H 70 0 h Pa 10 60 h Pa Separate collection for waste electrical and electronic equipment On base of control unit Serial number of the console On base of control unit Transportation & storage humidity limitation Transportation & storage atmospheric pressure limitation On package Transportation & storage temperature limitation On package On power adapter On base of control unit In manual On base of control unit and attachment tag On base of control unit On package On package On package On package On package 5 Place in and out of standby mode On side of control unit 6 Do not wash Do not dry clean Do not tumble dry Do not bleach Do not iron EU RF transmitter symbol Zone Boost icon FCC approved equipment authorization The Bluetooth figure mark On attachment tag On attachment tag On attachment tag On attachment tag On attachment tag In manual On control unit On control unit On control unit In manual and on control unit Warning symbol to identify a hazard that may lead to death or serious injury Caution symbol to indicate the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical control unit itself Tip to provide guidance to make use easier. Risk to user is considered negligible In manual In manual The Normatec 3 System is an air pressure massager indicated to temporarily relieve minor muscle aches and/or pains and INDICATIONS FOR USE to temporarily increase circulation to the treated areas. RISKS AND BENEFITS OF THE NORMATEC 3 SYSTEM The risks and benefits of using the Normatec 3 System are the same as having a massage. If the Normatec 3 massage feels uncomfortable, you can reduce the intensity or stop the session. Similar to a massage, the benefits include the temporary relief of minor muscle aches and pains. It also temporarily increases circulation in the area being massaged. Please call customer service at +1.949.565.4994 if you have any questions. 7 ILLUSTRATIONS Normatec 3 Control Unit 1. Power Button 2. Air outlet and power inlet 3. Attachment Selection button 4. Pressure Level button 5. Zone Boost button 6. Time adjustment button 7. Display screen 8. Bluetooth Status Indicator 9. Start/Stop button Normatec 3 Hose 1 1 3 2 1. Junction box air outlets 2. Junction box 3. Blocking plug (on the underside of the junction box) 4 4. Connector Normatec 3 Leg Attachment 2 2 2 2 2 2. Zones 1. Attachment connector 8 Normatec 3 Arm Attachment 1. Attachment connector 2. Zones Normatec 3 Hip Attachment 1. Attachment connectors 2. Zones Normatec 3 Power Supply 1. Wall outlet plug 2. Barrel connector WARNING! BEFORE OPERATING THIS CONTROL UNIT: Read all warnings at the beginning of this manual. If you do not understand these operating instructions, contact Hyperice at +1.949.565.4994. OPERATING INSTRUCTIONS SET UP THE SYSTEM Step 1: Plug the power supply into an electrical outlet and then into the Normatec 3 control unit. This control unit is equipped with a lithium ion battery. The battery automatically charges when the power supply is connected to the Normatec 3 control unit and an electrical outlet. 9 Step 2: Connect the hose connector to the air outlet on the Normatec 3 control unit. The connector can only be inserted in the correct orientation. Insert the connector firmly into the Normatec 3 control unit until you hear an audible click. Step 3: Put the leg, arm, or hip attachments on. Find a comfortable position sitting, reclined, or lying down. If the attachments have a zipper, be sure to zip up the attachments completely. Never try to use the system with the zipper partially or totally unzippedthis could void your warranty. Only one set of attachments can be used with a single control unit. When using more than one attachment, make sure they are both of the same type. Step 4: Connect the attachment connectors on each attachment to the junction box air outlets. The attachment connectors can only be connected to the junction box in the correct orientation. Insert the attachment connectors firmly into the junction box air outlets until you hear an audible click. If only one attachment will be connected to the junction box, use the blocking plug located on the underside of the junction box to block off the unused junction box air outlet. Press firmly to make sure the blocking plug is fully seated. Step 5: Press the power button on the Normatec 3 control unit firmly for one second to turn on the system. While the control unit is on, the LED indicators and display on the control panel will be lit up according to your settings. To set the device to run the appropriate treatment for the attachment you are using, press the Attachment Selection button to select either Legs, Hips or Arm attachment. When Hips are selected the device will automatically run a 2 -zone SELECT YOUR ATTACHMENT treatment to match the number of zones on the Hips. ADJUST THE PRESSURE LEVEL Adjust the pressure level of the session by pressing the Pressure Level adjustment button on the left of the level indicator s. Pressure level 1 is the gentlest setting. The massage becomes stronger as the pressure level is increased. Level can be adjusted while the session is running. When level is adjusted during a session, the system will pause. Once you have finished adjusting your level, press the Start/Stop button to resume treatment at the new pressure. USE ZONE BOOST During your session, you can increase the intensity of a single zone with the Zone Boost feature. Zone Boost is designed to be used when you want extra attention in a specific area. Zone Boost will add an extra 60 seconds of massage time, as well as 10 mmHg increased pressure, in the selected zone. Zone Boost can be enabled before or during a session. Only one zone can be boosted at a time. To boost a zone press the Zone Boost button until the LED indicator above the zone you want to boost is lit up. To disable Zone Boost press the Zone Boost button until no Zone LED indicators are lit up. The zones on the attachment are numbered in ascending order from distal zone to proximal zone. So if you are using the leg attachments, Zone 1 would be your foot/ankle, Zone 2 would be your calf, Zone 3 your knee, Zone 4 lower quad and Zone 5 upper quad. 10 ADJUST THE SESSION TIME Adjust the session time by pressing the time adjustment button on the left of the Display Screen. The session time can be set to 15, 30, 45 and 60 minute intervals. Time can be adjusted while the session is running. Tap the time adjustment buttons to cycle through the time intervals to add or subtract time from the session. START THE SESSION To start the session, tap the Start/Stop button. PATENTED NORMATEC PULSE MASSAGE PATTERN Before the patented NORMATEC PULSE massage pattern begins, you will experience a pre-inflate cycle, during which the connected attachments are molded to your exact body shape. Once the pre-inflate cycle is complete, the patented NORMATEC PULSE massage pattern will begin by compressing your feet, hands, or upper quad (depending on which attachment you are using). Similar to the kneading and stroking performed during a massage, each zone of the attachments will first compress in a pulsing manner and then release as the compression pattern works its way up your limb. When the top zone completes its massage, there will be a brief rest period and then the cycle will begin again. This will repeat until the session time runs out. When the session is resumed after a pause, the system will perform a pre-inflate cycle before continuing. STOP OR PAUSE THE SESSION To stop the session at any time, tap the Start/Stop button. This will pause the session. To restart your paused session, tap the Start/Stop button again. If you are done using the system, remove the attachments from the hose, remove the attachments from your limbs, turn off the control unit by pressing the power button, and disconnect the hose from the To disconnect connectors from the junction box or the control unit, push the button on the top of each connector while control unit. pulling away. FINISH THE SESSION unit. pulling away. The session will continue massaging until time runs out and the display reads Finishing Cycle. The control unit will continue until the current cycle is finished. When the session is completed, remove the attachments from the hose, remove the attachments from your limbs, turn off the control unit by pressing the power button, and disconnect the hose from the control To disconnect connectors from the junction box or the control unit, push the button on the top of each connector while TURN OFF THE CONTROL UNIT To turn off the system, press the power button and confirm that the LED indicators and display are OFF. 11 CARING FOR THE SYSTEM CLEANING THE SYSTEM To clean the control unit:
Wipe down the system with a damp, clean cloth. Dry thoroughly with a clean cloth. Cleaning the leg, arm, or hip attachments:
Wipe down the legs, arms, or hip attachments inside and out with a damp, clean cloth after each use. Dry thoroughly with a clean cloth. Do not machine wash or dry. Do not dry clean. MAINTAINING THE SYSTEM except for the care in this section. STORING THE SYSTEM REPLACEMENT PARTS replacement parts and accessories. TECHNICAL INFORMATION BLUETOOTH WIRELESS TECHNOLOGY in. 12 The control unit, hose, power supply, and attachments (legs, arms, or hips) require no routine maintenance or service Store control unit, hose, power supply, and attachments (legs, arms, or hips) in a clean, dry location. Please call customer service at +1.949.565.4994 or visit our website at hyperice.com for information regarding available Do not attempt to take apart the system. The system has no user-serviceable parts. There are no user-replaceable fuses. The Bluetooth word mark and logos are owned by Bluetooth SIG, Inc., and any use of such marks by Hyperice is under license. In the unlikely event of loss of a stable Bluetooth connection, the system will attempt to re-establish its connection automatically. The Normatec 3 control unit is completely autonomous, and will continue operating normally, even during a loss of connectivity. If this control unit does cause interference, which can be determined by turning the control unit off and on, the user is encouraged to try to correct the interference by reorienting or relocating the control unit, increasing the separation between equipment and the control unit, or connecting the control unit to a different outlet on a circuit if it is plugged The Normatec 3 control unit uses Bluetooth 5.0 wireless technology with the following radio specifications:
Frequency Modulations Transmit Power 2402 to 2480 MHz GFSK
+4 dBm Receiver Sensitivity
-96 dBm (BLE mode) Security AES HW FCC ID: 2AY3Y-NT3 IC: 23655-NT3 This control unit complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This control unit may not cause harmful interference, and (2) this control unit must accept any interference received, including interference that may cause undesired operation. This control unit complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this control unit may not cause interference, and (2) this control unit must accept any interference, including interference that may cause undesired operation of the control unit. This equipment complies with FCC/ISED radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the ISED radio frequency (RF) Exposure rules. This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption rate (SAR). Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to op erate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instru ctions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- 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. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : (1) lappareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le onctionnement. 13 Cet quipement est conforme aux limites d'exposition aux rayonnements FCC / ISED dfinies pour un environnement non contrl et rpond aux directives d'exposition aux frquences radio (RF) de la FCC et la norme RSS-102 des rgles d'exposition aux frquences radio (RF) d'ISDE. Cet quipement a de trs faibles niveaux d'nergie RF qui sont jugs conformes sans test de taux d'absorption spcifique (SAR). INTERNAL BATTERY INFORMATION This Normatec 3 control unit is equipped with a rechargeable lithium ion battery. The internal battery is designed to allow use of the Normatec 3 System anywhereeven when power outlets arent available. The Normatec 3 control unit may need to be plugged in before first use. The battery will provide power for 2+ hours of continuous use. It takes approximately 6 hours to fully charge the battery when the control unit is plugged in and not in use. The rechargeable lithium ion battery is intended to be changed only by authorized service personnel with the use of a special service tool. Normatec 3 Dimensions: 4 (width), 4 (depth), 8.5 (height); [10.2 cm (width), 10.2 cm (depth), 21.6 cm (height)]
PRODUCT SPECIFICATIONS Normatec 3 Model REJ6 Normatec 3 Weight: 3.2 lbs [1.45 kg]
Normatec 3 electrical requirement: 15V DC 1 A Maximum Air Pressure: 110 mm Hg Temperature (operating): +41 F to 104 F [+5 C to +40 C]
Temperature (storage): -13 F to +158 F [-25 C to +70 C]
Relative Humidity (operating): 15% to 93%, non-condensing Relative Humidity (storage): -25 C without relative humidity control; +70 C at relative humidity up to 93%, non-
condensing Atmospheric pressure (storage and transportation): 190hPa to 1060hPa Atmospheric pressure (operating): 700hPa to 1060hPa AC-DC ADAPTER WARNING! Only use the AC-DC adapter model number 30120 provided with the system. Using a different adapter may cause the system to not operate correctly. Input: 100-240V 0.8-0.4 A 50/60 Hz per Normatec 3 model number 60090-001-00 Output: 15V DC minimum 1.6 A per Normatec 3 model number 60090-001-00 ELECTROMAGNETIC COMPATIBILITY The information contained in this section (such as separation distances) is in general specifically written with regard to the Normatec 3. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of 14 such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference. GENERAL NOTES Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this document and the remainder of the instructions for use of this control unit. Portable and mobile RF communications equipment can affect medical electrical equipment. Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity). Care should be taken if the equipment is used adjacent to or stacked with other equipment; if adjacent or stacked use is inevitable, the equipment should be observed to verify normal operation in the configuration in which it will be used. 15 ELECTROMAGNETIC EMISSIONS assure that it is used in such an environment. This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should Compliance According To Electromagnetic Environment Group 1 The equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. CISPR emissions Class B The equipment is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emissions RF emissions
(CISPR 11) classification Harmonic emissions Class A
(IEC 61000-3-2) Voltage fluctuations/
Complies flicker (IEC 61000-3-3) ELECTROMAGNETIC IMMUNITY Immunity Against Electrostatic Contact Discharge:
discharge, ESD 8 kV
(IEC 61000-4-2) Air Discharge:
15 kV This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment. IEC 60601-1-2 Test Level Electromagnetic Environment Compliance Level (of this control unit) 8 kV 15 kV Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be kept at levels to reduce electrostatic charge to suitable levels. Mains power quality should be that of a typical commercial or hospital Electrical fast Power Supply Lines: 2 kV transients/bursts Input DC Power Ports 2 kV 2 kV 2 kV 1 kV
(IEC 61000-4-4) Signal Input/Output Lines: 1 kV environment. 16 RF Proximity 385 Pulse Modulation, 18 Hz Equipment with high RF emissions
(IEC 61000-4-3) 450 FM + 5Hz deviation: 1 kHz sine should be kept at a distance to reduce the likelihood of interference. 710 745 810 870 1720 1845 5240 5500 780 Pulse Modulation: 217 Hz 930 Pulse Modulation: 18 Hz 1970 Pulse Modulation: 217 Hz 2450 Pulse Modulation: 217 Hz 5785 Pulse Modulation: 217 Hz 27 V/m 28 V/m 9 V/m 28 V/m 28 V/m 28 V/m 9 V/m 2 kV 1 kV Surges on AC Common Mode: 2 kV mains lines Differential Mode: 1 kV
(IEC 61000-4-5) magnetic field 50/60 Hz
(IEC 61000-4-8) Mains power quality should be that of a typical commercial or hospital environment. power line magnetic fields (in excess of 3A/m) should be kept at a distance to reduce the likelihood of interference. Power frequency 30 A/m 30 A/m Equipment that emits high levels of Voltage dips Dip > 95%, 0.5 cycles and short Dip > 95%, 1 cycle 0.5 cycles 1 cycle Mains power should be that of a typical commercial or hospital environment. If interruptions on Dip 30%, 25 cycles (50 Hz) 25 cycles (50 Hz) you require continued operation during AC mains input 30 cycles (60 Hz) 30 cycles (60 Hz) power mains interruptions, ensure that lines Drops >95%, 250 cycles (50 Hz) 250 cycles (50 Hz) batteries are installed and charged.
(IEC 61000-4-11) 300 cycles (60 Hz) 300 cycles (60 Hz) Ensure that battery life exceeds longest anticipated power outages or provide additional uninterruptible power source. 17 This equipment is intended for use in the electromagnetic environment specified below. The customer or the user of this equipment should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level RF coupled into MHz lines outside ISM
(IEC 61000-4-6) bandsa Radiated RF 150 kHz to 80
(IEC 61000-4-3) MHz Conducted RF 150 kHz to 80 3 Vrms Recommended separation distance:
Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below. d=1.2/V1]P d=1.2/P 80 MHz to 800MHz d=2.3P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter 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 rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
in ISM bandsa manufacturer and d is the recommended separation a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. b 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 the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. 18 RECOMMENDED SEPARATION DISTANCES Recommended separation distances between portable and mobile RF communications equipment and the Normatec 3 control unit. Rated maximum output power of transmitter W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitters in meters 150 kHz 80 MHz 80 MHz to 800MHz 800 MHz to 2.5 GHz d=1.2/V1]P d=1.2/V1]P d=2.3P 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 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. EQUIPMENT CLASSIFICATION Protection against electric shock: Class II/internally powered equipment Degree of protection against electric shock: Type BF applied part (control unit, leg, arm, and hip attachments) Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous Ingress protection: IP21 oxide Continuous operation 19 TROUBLESHOOTING start Problem Possible Causes Solutions The system does not Power is not turned on Press the power button to turn the control unit on. Power supply is not Check that the power supply is securely connected to the securely connected Normatec 3 control unit and the electrical outlet. Faulty electrical wall Check that the wall outlet works. outlet The attachments (legs, The session has not Tap the start button to start the session. arms, or hips) do not been started inflate The hose is not securely Check that the hose is securely connected to the Normatec 3 connected control unit and that the attachments are securely connected to the junction box. The attachments have Check that the attachments do not have an air leak. been damaged The system stopped The hose is not securely Check that the hose is securely connected to the Normatec 3 pumping connected control unit and that the attachments are securely connected The attachments have to the junction box. been damaged Check that the attachments do not have an air leak. Air leak message: ERR Air leak Check for leaks in the hose or attachment. Check that the connectors are firmly connected. Low Battery Battery needs to be Plug in the control unit to charge the battery. charged Please see page 10 for battery functionality. Bluetooth is turned off on mobile device Turn on Bluetooth on the phone attempting to pair with the Normatec 3 control unit. Call Hyperice customer service at +1.949.565.4994 if further assistance is needed. Cannot establish or maintain a Bluetooth connection 20 WARRANTY INFORMATION Normatec 3 System Limited One-Year Warranty The Normatec 3 control unit is warranted by Hyperice, a California corporation (Hyperice), against manufacturing defects in material and workmanship for a period of one year from the date of purchase from Hyperice. In the event of any such defect occurring during the warranty period, Hyperice will, at its option, (a) correct the defect by repair or by replacement of the applicable part or component that fails as a result of such defect, without charge for parts and labor; or
(b) replace the control unit with one of the same or then current design. The Normatec 3 attachments and other accessories include the leg attachments, hip attachment, arm attachments, power supply, and hosing. Normatec 3 attachments and other accessories are warranted by Hyperice against manufacturing defects in material and workmanship for a period of one year from the date of purchase from Hyperice. In the event of any such defect occurring during the warranty period, Hyperice will, at its option, (a) correct the defect by repair or by replacement of the applicable part or component that fails as a result of such defect, without charge for parts and labor; or (b) replace the control unit with one of the same or then current design. The foregoing Warranties do not cover normal wear and tear or cosmetic damage, and are void if the control unit and/
or the attachments and other accessories (collectively, the product) are not used in accordance with the user manual, are otherwise misused or modified in any way, and/or are repaired or altered by anyone other than an authorized service representative of Hyperice. These Warranties expressly exclude transportation, shipping or insurance costs, or defects, damages, or failure resulting from misuse, abuse, improper or abnormal usage, or neglect. EXCEPT AS PROVIDED ABOVE, HYPERICE 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. EXCEPT AS EXPRESSLY STATED ABOVE, HYPERICE SHALL HAVE NO LIABILITY OR RESPONSIBILITY TO ITS CUSTOMER OR ANY OTHER PERSON OR ENTITY WITH RESPECT TO ANY LIABILITY, LOSS, OR DAMAGE CAUSED DIRECTLY OR INDIRECTLY BY USE OR PERFORMANCE OF THE PRODUCT OR ARISING OUT OF THE USE OR INABILITY TO USE THE PRODUCT OR ANY BREACH OF THESE WARRANTIES, INCLUDING BUT NOT LIMITED TO ANY DAMAGES RESULTING FROM INCONVENIENCE, LOSS OF TIME, PROPERTY, OR INCOME, OR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusions may not apply to you. These Warranties give you specific legal rights, and you may also have other rights, which vary from state to state. In the event of a product defect covered by the foregoing Warranties during the applicable warranty period, contact Hyperice at +1.949.565.4994 or customersupport@hyperice.com. 21 All replaced parts and products become the property of Hyperice. New or reconditioned parts and products may be used in the performance of Warranty service. Repaired or replaced parts and products are warranted for the remainder of the original warranty period only. You will be charged for repair or replacement of parts and products made after the expiration of the applicable Warranty period. RETURN POLICY This policy is only applicable if you are an end user and you purchased the equipment directly from Hyperice. In the unlikely event that you are not satisfied with your purchase, you may return it within thirty (30) days of the purchase date. If you purchase incorrectly sized attachments, they may be exchanged within fourteen (14) days of the purchase date. All returns and exchanges are subject to the conditions listed below. Returns and exchanges must have a Return Merchandise Authorization (RMA) number. Obtain an RMA number by contacting us at +1.949.565.4994 or customersupport@hyperice.com. Returned items without an RMA number will not be eligible for a credit to your account. Returns must be shipped within 30 days of the purchase date; exchanges must be shipped within 14 days of the Products and packaging must be returned in new and undamaged condition. Any products showing signs of wear or being soiled in any way will be deemed unacceptable, and you will be so notified. Unacceptable returns and/or exchanges may be reshipped to you following payment of an inspection/shipping fee. Returned items will be subject to a 7.5% restocking fee. A returned item is an item that is being sent back for a purchase date. refund. If you refuse delivery of your order for any reason, you will be refunded the cost of your order less shipping fees. All partial or full refunds will be posted to the credit card used for purchase. Hyperice is not responsible for items lost or damaged during shipping. 22 hyperice.com NormaTec Industries, LP 480 Pleasant Street, Suite A200 Watertown, Massachusetts 02472 USA Copyright 2021 Hyperice, Inc. All rights reserved. 70-00069 Rev 1 23
1 | Label | ID Label/Location Info | 105.87 KiB | July 06 2021 |
FCC ID:2AY3Y-NT3 IC:23655-NT3 CAN ICES-003(B)/NMB-003(B) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Main Label will screen printing on main board refer to external photo of report. Battery Label will screen printing on battery door refer to external photo of report.
1 | Applicant cover letter | Cover Letter(s) | 586.31 KiB | July 06 2021 |
SGS North A\ I e . SG S 820 Old Peachtree Read Applicant Declaration SUITE 100 Suwanee, Georgia 30024 United States
[ Applicant Legal Business Name NormatTec Industries LP Address 480 Pleasant St. Ste A200, Watertown, Massachusetts 02472, United States Grantee Code 2AY3Y
| Foc iD | 2AY3Y-NT3 Authorized Contact Name | Steve Henderson Contact Email regulatory@bhyperice.com Contact Phone 617.658.5857
|, the undersigned, certify that | am an authorized signatory for the Applicant and therefore declare;
a) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. b) in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:
(1) labeling the equipment with the exact FCC ID as specified in this application,
(2) compliance statement labeling pursuant to the applicable rules,
(3) compliance of the equipment with the applicable technical rules, c) if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCC's technical requirements. d) in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2 909 and KDB394321 e) in accordance with IS017065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements
(1) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing
(2) the Applicant shel! make provisions to always have a production sample available upon request by SGS, FCC and/or ISED.
(3) the Applicant sha/!, upon request by SGS, at the Applicant's expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed, The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS f) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. g) the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www fcc. gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fec.gov/oetct/kdb/index.cfm Link to RSP-100: https.// ic.qc.ca/eic/site/s! st.nsf/ena/sf01130.html Date:
{ April 26, 2021 Applicant Signatpre:
Print Name: _| Steve Henderson |
Title: uality Systems & Regulatory Manager |
NOTE. This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database Applicant Declaration Rev:0.0
1 | Confidentiality Letter | Cover Letter(s) | 612.87 KiB | July 06 2021 |
Normatec Industries LP TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: Confidentiality Request regarding application for FCC ID; 2AY3-NT3 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby requests confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 DO1 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Print Name: Steve Henderson Title: Quality Systems & Regulatory Manager Signature: Aa On behalf of Company: Normatec Industries LP Telephone: 617.658.5857 E-mail: regulatory@hyperice.com
1 | Power of Attorney Letter | Cover Letter(s) | 383.36 KiB | July 06 2021 |
NormatTec Industries LP Date: April 26, 2021 TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding: 2AY3Y-NT3 To whom it may concern:
We, the undersigned, hereby authorize SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch and Keny Xu in SGS-CSTC Standards Technical Services Co., Ltd. (SGS) Shenzhen Branch to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, | acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with NormaTec Industries LP This authorization is valid until further written notice from the applicant. Print Name: Steve Henderson Title: Quality Systems & Regulatory Manager Signature: Ae L~
On behalf of Company: NormaTec Industries LP Telephone: 617.658.5857 E-mail: regulatory@hyperice.com
1 | Test setup photo | Test Setup Photos | 585.94 KiB | July 06 2021 / January 03 2022 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-07-06 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-07-06
|
||||
1 | Applicant's complete, legal business name |
NormaTec Industries LP
|
||||
1 | FCC Registration Number (FRN) |
0027262146
|
||||
1 | Physical Address |
480 Pleasant St. Ste A200
|
||||
1 |
480 Pleasant St.
|
|||||
1 |
Watertown, MA
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AY3Y
|
||||
1 | Equipment Product Code |
NT3
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
S**** H****
|
||||
1 | Title |
Quality System and Regulatory Manager
|
||||
1 | Telephone Number |
61765********
|
||||
1 | Fax Number |
86629********
|
||||
1 |
s******@hyperice.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd.
|
||||
1 | Name |
K**** X******
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
+8675********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/03/2022 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Normatec 3 | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd
|
||||
1 | Name |
D****** Y********
|
||||
1 | Telephone Number |
+86 0********
|
||||
1 |
D******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0025000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC