6
Safety Information
·
Equipment Classification
As per the International Electrotechnical Commission standard IEC 60601
-
1, and
the European standard EN 60601
-
1, Medical Electrical Equipment, General
Requirements for Basic Safety and Essential Performance, the NexWave is
classified as follows:
·
Type BF Equipment
A Type BF piece of equipment is one that provides a particular degree of
protection against electric shock, particularly regarding allowable leakage
current. Type BF applied part is one that is floating above ground and is
isolated from all other parts of the equipment.
·
Internally Powered Equipment
When the NexWave is powered by the internal, 9 VDC, MN1604, battery it is
classified as Internally Powered Equipment.
·
Class II Medical Equipment
When powered by the external, 12 VDC, medical grade, power supply, the
NexWave is classified as Class II Medical Electrical (ME) Equipment. Note:
When the external power supply is connected to the NexWave device, the
power supply is considered part of the ME equipment.
·
Electromagnetic Compatibility
Conforms to IEC 60601
-
1
-
2.
·
Temperature
Operating temperature range: 0°
-
40° C (32°
-
104° F)
Storage temperature range:
-
20°
-
70° C (
-
4°
-
158° F)
·
Water Ingress
Ordinary equipment. This device does not have protection against ingress of
water.
·
Flammable Anesthetics
This device is not suitable for use in the presence of a flammable anesthetic
mixture with air, or in the presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.
43
NexWave
Specifications and Accessories
Interferential Current (IFC)
Amplitude:
0
-
50 mA
Channel 1 frequency:
4000 Hz
Channel 2 frequency:
4001
-
4128 Hz
I/F Modes:
Low
-
High, Low, Combo
Muscle Mode:
64 Hz, 6 sec. on, 6 sec. off, ramp up 1 sec., and ramp down 0.5 sec.
Waveforms:
Symmetrical biphasic
Transcutaneous Electrical Nerve Stimulation (TENS)
Amplitude:
0
-
100 mA
Frequency:
1
-
125 Hz
Pulse Width:
120
-
300 µs
TENS Modes:
Sweep, Low frequency Modulation, High frequency Modulation
Waveform:
Symmetrical biphasic
Neuromuscular Electrical Stimulation (NMES)
Amplitude:
0
-
100 mA
Frequency:
35 Hz
Pulse Width:
480 µs
NMES Modes:
30:10, 20:10, 10:10
On
-
Time:
10 sec.
Off
-
Time:
30, 20, or 10 sec.
Ramp Up:
3 sec.
Ramp Down:
1 sec.
Waveforms:
Symmetrical biphasic
Other Specifications
Treatment timer:
10 to 90 minutes, in 10 minute increments, with no timer setting
Compliance meter:
Records total usage time in minutes and number of times used
Dimensions:
2.9 x 4.6 x 1.0 in.
Weight:
5.8 oz. including battery
Warranty:
5 year manufacturer’s warranty on materials and workmanship
Accessories excluded
Accessories
Lead wires:
104203, lead wire, black, with black pins
104204, lead wire, gray, with red pins
Electrodes:
300027, electrodes, 2” diameter, round, pkg. of four
300100, electrodes, sterile, 2” x 2”, square, pkg. of four
Power supply:
200109, power supply, medical grade, input 100
-
240 VAC, 50
-
60 Hz,
0.3 A max., output 12 VDC, 0.5 A max
Battery:
130010, battery, 9 V, alkaline, MN1604
Summary of Contents for NexWave
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