HYPERICE Normatec Elite Operating Instructions Manual page 5

Changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate 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 instructions, 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 présent appareil est conforme aux CNR d'Innovation, Sciences et Développement économique Canada
applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions
suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout
brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le onctionnement.
INTERNAL BATTERY INFORMATION
This Normatec Elite control unit is equipped with a rechargeable lithium ion battery. The internal battery is designed to
allow use of the Normatec Elite anywhere—even when power outlets aren't available. The Normatec Elite control unit
may need to be plugged in before first use. A fully charged battery will provide power for 3+ hours of continuous use. It
takes approximately 5 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. Battery voltage and capcity: 7 .2V, 5000 mAh / 7 .38V, 4800 mAh
PRODUCT SPECIFICATIONS
• Normatec Elite Model: JPN11 -SH, JPN11-ST, JPN11-TL, JPN11-PH, JPN11-PS, JPN11-PT
• Hardware versions: V1.3, V1.4, V1.5, V1.6, V1.7 , V1.8, V1.9, V1.10, V1.11, V1.12, V1.13, V1.14
• Normatec Elite Dimensions: 4" (width), 4" (depth), 8.5" (height); [10.2 cm (width), 10.2 cm (depth), 21.6
cm (height)]
• Normatec Elite Weight: 3.2 lbs [1.45 kg]
• Normatec Elite electrical requirement: 12V
• 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 SMS-01120400-S68 provided with the
device. Using a different adapter may cause the device to not operate correctly.
• Input: 100-240V 1.5 A 50/60 Hz
• Output: 12V DC minimum 4 A
ELECTROMAGNETIC COMPATIBILITY
The information contained in this section (such as separation distances) is in general specifically written
with regard to the Normatec Elite. The numbers provided will not guarantee faultless operation but should
provide reasonable assurance of 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.
DC 4 A
WARNING!
• 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 the Normatec Elite, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• The Normatec Elite should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use is necessary, the Normatec Elite should be observed to verify normal operation. If
operation is not normal, the Normatec Elite or the other equipment should be moved.
• Use of accessories, transducers and cables other than those specified or provided by the manufacturer
of this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
• Avoid exposure to known sources of EMI (electromagnetic interference) such as diathermy, lithotripsy,
electrocautery, RFID (Radio Frequency Identification), and electromagnetic security systems such as anti-
theft/electronic article surveillance systems, metal detectors. Note that the presence of RFID devices may not
be obvious. If such interference is suspected, reposition the equipment, if possible, to maximize distances.
ELECTROMAGNETIC EMISSIONS
This equipment is intended for use in the electromagnetic environment of clinics, hospitals, athlete training,
or home environments. The user of this equipment should assure that it is used in such an environment.
Compliance
Emissions Electromagnetic Environment
According To
RF emissions Group 1 The equipment uses RF energy only for its internal
(CISPR 11) 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,
classification including domestic establishments and those directly
connected to the public low-voltage charger network
that supplies buildings used for domestic purposes.
Harmonic emissions Class A
(IEC 61000-3-2)
Voltage fluctuations/ Complies
flicker (IEC 61000-3-3)
ELECTROMAGNETIC IMMUNITY
During the immunity testing described below the Normatec Elite continued to provide therapy normally.
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.
Compliance
Immunity
Level (of this Electromagnetic Environment
Against
control unit)
Electrostatic ± 8 kV Direct Floors should be wood, concrete, or ceramic tile. If floors
discharge, ESD are covered with synthetic material, the relative humidity
(IEC 61000-4-2) ± 2,4,8,15 kV should be kept at levels to reduce electrostatic charge to
suitable levels.
Electrical fast ± 2 kV Mains power quality should be that of a typical clinic,
transients/bursts hospital, athletic training, or home environment.
(IEC 61000-4-4)
RF Proximity 27 V/m 28 V/m Equipment with high RF emissions should be kept at a
(IEC 61000-4-3) 9 V/m 28 V/m distance to reduce the likelihood of interference.
28 V/m 28 V/m
9 V/m