EMPI Active
User Guide
EMPI Active
User Guide
7
Prescribing Information
continued
Uterus:
Do not use electrical stimulation over a menstruating or pregnant uterus.
Sensory loss:
Do not use electrical stimulation where sensory nerve damage is
present, causing a loss of normal skin sensation.
Prescription:
Use electrical stimulation only in the prescribed manner and for the
prescribed diagnosis. If there are any changes in an existing condition, or if a new
condition develops, the patient should consult a healthcare professional.
Effectiveness:
Effectiveness is highly dependent upon patient selection by a
healthcare professional qualified in the management of pain or rehabilitation.
Keep out of reach of children:
Keep this device out of the reach of children.
If the patient is a child, make sure he/she is properly supervised during
electrical stimulation.
Leads and Electrodes:
Use the device only with the electrodes or conductive
garment provided for use by the manufacturer. The safety of other products has
not been established, and their use could result in injury to the patient. Use only the
electrode placements and stimulation settings prescribed by your practitioner.
NOTE:
An electrode active area of no less than 1.2 in
2
(7.9 cm
2
) is recommended for the Empi Active.
Electronic equipment:
Electronic monitoring equipment (such as ECG and ECG
alarms) may not operate properly when electrical stimulation is in use.
Microwave or radio frequency sources:
Operation in close proximity, such as 3
feet (1 meter), to shortwave or microwave therapy equipment may produce instability
in the device output and may shut the device off.
Machinery operation:
Patient should never operate potentially dangerous
machinery such as power saws, automobiles, etc. during electrical stimulation.
Flammable:
Do not use the device in an environment where flammable or explosive
fumes may exist.
External use:
This device is for external use only.
Electromagnetic energy:
Do not operate this unit in an environment where other
devices are being used that intentionally radiate electromagnetic energy in an
unshielded manner. Portable and mobile RF communications equipment can affect
medical electrical equipment.
Sharp objects:
Do not use sharp objects such as a pencil point or ballpoint pen to
operate the buttons on the device.
Connectors:
Inspect connectors before each use.
Treatment outcome:
Treatment outcome will be influenced by the patient’s
psychological state and use of drugs.
Prescribing Information
continued
Negative reaction to stimulation:
Patients who react negatively to the stimulation
sensation after an adequate trial period or who find stimulation intolerable should not
undergo further treatment.
Operation conditions:
This unit should be operated in temperatures between 50° F
and 104° F (10° C and 40° C), atmospheric pressures between 50 kPa and 106 kPa,
and relative humidity between 30% and 75%.
Transportation and storage conditions:
This unit should be transported and
stored in temperatures between -40° F and 158° F (-40° C and 70° C), atmospheric
pressures between 50 kPa and 106 kPa, and relative humidity between 10% and 90%.
Using device while sleeping:
Do not use while sleeping because the electrode or
specialized wrap may become disconnected.
Heat and cold products:
The use of heat or cold producing devices, such as
electric heating blankets, heating pads or ice packs, may impair the performance of
the electrode or alter the patient’s circulation/sensitivity and increase the risk of injury
to the patient.
Battery charger:
Only the Empi battery charger should be used to charge the
battery in the device.
Radio frequency generation:
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 other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular installation.
Harmful interference to other devices can be determined by turning the unit on and
off. Try to correct the interference using one or more of the following: reorient or
relocate the receiving device, increase the separation between the equipment, or
consult the Empi Service Department (800.328.2536) for help.
Dangers
Dangerous voltage:
Stimulus delivered by the TENS waveform of
this device, in certain configurations, will deliver a charge of up to 20
microcoulombs (μC) or greater per pulse and may be sufficient to cause
electrocution. Electrical current of this magnitude must not flow through
the thorax (chest) because it may cause a cardiac arrhythmia.
Biohazardous materials:
Handle, clean, and dispose of components
and accessories that have come in contact with bodily fluids according to
national, local, and facility rules, regulations, and procedures.
Adverse Effects
Skin irritation, inflammation, and burns beneath the electrode are potential
adverse reactions.
BIOHAZARD
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