Empi 199580-001, Руководство пользователя

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Select User’s Manual
12
Select User’s Manual 13
Prescribing Information Prescribing Information
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 control panel.
Cables and connectors
– Inspect cables and connectors before each use.
Treatment outcome
– Treatment outcome will be influenced by the patient’s
psychological state and use of drugs.
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 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 and 106 kPa, and relative humidity between 10% - 90%.
Batteries
– Remove the Select system batteries if the unit is to be unused for an extended
period of time, i.e. 2 weeks or more.
Transportation of batteries
– Do not carry batteries in a pocket, purse or any other
place where the terminals could become short-circuited, e.g. by way of a coin or paper clip.
Intense heat could be generated and injury may result.
Using device while sleeping
– Do not use while sleeping because the lead wires or the
electrodes 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 with Empi rechargeable
batteries. Do not attempt to recharge any battery other than the rechargeable battery
supplied by Empi for this device. Attempts to charge alkaline or other non-rechargeable
batteries could cause the battery to overheat, burst, or be permanently damaged.
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 orrelocate the receiving device,
increase the separation between the equipment and consult the Empi Service Department
for help.
Adverse Effects
Skin irritation, inflammation, and electrode burns beneath the electrodes are potential
adverse reactions.
Dangers
Dangerous voltage
– Stimulus delivered by the TENS waveforms 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 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.
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