XFT MEDICAL 2001E User Manual
XFT-2001E
Nerve and Muscle Stimulator (Trade name: Foot Drop System)
User Manual
Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in
which he/she practices to us e or order the use of the device.
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Content
1. For Your Health and Safety ................................................................................................................................... 3
2. Overviews ............................................................................................................................................................ 10
3. Product Illustration ...............................................................................................................................................11
4. Operation Instruction ........................................................................................................................................... 13
5. Attentions ............................................................................................................................................................. 18
6. Care and Maintenance ......................................................................................................................................... 19
7. FAQ & Troubleshooting ...................................................................................................................................... 19
8. Product Configuration ......................................................................................................................................... 20
9. Product classification ........................................................................................................................................... 21
10. After-sales Service ............................................................................................................................................. 22
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1. For Your Health and Safety
Declaration of conformity according to the applicable European directives and number of the
To avoid any danger or loss caused by inappropriate use, please read this manual carefully;
In the precautions, the hazards and losses caused by improper use are stated, and the safety precautions are divided
into three parts: “contraindications”, “warning” and “attention”;
Please keep this manual carefully.
List of Symbols
Contraindications, or will cause danger
Mandatory Abidance, or will c a us e acc ident / physical discomfort
Type BF Equipment
Use with Caution
Non-ionizing radiation
Date of manufacture
Manufacturer
Serial Number
notified body (0123)
European Authorize d Representative
Consult instructions for use
Please dispose of the device/battery/accessory/packing in accordance with the legal obligation in
your area
Contraindications
Do not use with electronic monitoring equipment, NMR-imaging, pace-maker, defibrillator and high-frequency
medical device.
Do not use near short-wave, microwave. (such as 1m)
Patients with heart disease, severe hypertension and skin disorder are forbidden to use this product.
Patients with epilepsy are forbidden to use this product.
Patients with active hemorrhage, acute purulent Inflammation, malignant neoplasms, thrombophlebitis, sepsis and
cardiopulmonary failure are forbidden to use this product.
Do not use this product for purpose other than treatment.
Do not apply this product to unconscious patients.
Do not disassemble, repair or rebuild this product.
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Do not touch the charging connector/battery and the patient simultaneously when charging/using.
Warning
The safety of usage durin g p regnancy or menstruati on has not been determined.
Electrode positioning and stimulation parameters’ setting should be conducted by professionals. If you keep
feeling pains or rash, ple a s e s t op us ing this product.
Please do not position the electrode in the area of malignant neoplasms, neck arteries (throat) or thrombus.
Be careful if the electrode positioning areas show following situa t ions:
– Bleeding trend caused by serious trauma;
– Muscle training might cause disorder of rehabilitation of a recent surgery;
– Electrode positioning areas are not sensitive enough.
Please use with caution when the arteries of used area show partial occlusion, when the patient has vascular
atrophy because of hemodialysis, or when the vascular system shows instability.
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Please use with caution when the output current density exceeds 10mA/cm
(r.m.s).
Please use with caution if the used areas have structural deformity.
This product should be con ducted by doctors.
Patients should keep stable and not move while using this unit.
Patients should not move the electrode or be touched while using this unit.
Please stop using this product if the body shows any physical abnormality.
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.
FCC warning:
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment.
Note: 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.
The device has been evaluated to meet general RF exposure requirement. The device can be used in portable
exposure condition without restriction.
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This equipment uses RF energy only for its internal function.
voltage power
Electromagnetic Compatibility (EMC)
This equipment generates, uses, and radiates radio frequency energy. The equipment may cause radio frequency
interference to other medical or non-medical devices and to radio communications.
If this equipment is found to cause interference, which can be determined by turning on and off the equipment, the
operator or qualified service personnel should take following actions:
Reorient or relocate the affected device;
Increase the distance between the equipment and the affected device;
Power the equipment by another source;
Consult the service engineer for further suggestions.
Caution: it is customer’s responsibility to assure that this equipment and vicinity equipment comply with the contents of
th
IEC 60601-1-2 4
Edition.
Caution: do not use any device that might send out RF signals, including cell phone, radio transceiver and radio control
products, which might cause operation parameters beyond the standards. Please shutdown these devices when you are
near the equipment. Operator has the responsibility to warn user or any others to comply with this rule.
Caution: manufacturer will not responsible for any unauthorized actions that cause interference.
Table 1
Guidance and manufacture’s declaration – electromagnetic emission
This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is
used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
Its RF emissions are very low and are not likely to cause any
interference in nearby electronic.
RF emissions
CISPR 11
Harmonic emissions
Class B This equipment is suitable for domestic establishments and
those directly connected to the public low-
Class A
supply network.
IEC 61000-3-2
Voltage fluctuations/flicker
Complied
emissions
IEC 61000-3-3
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±0.5kV, ±1kV
±0.5kV, ±1kV
Voltage dips
0 % UT; 0.5 cycle
0 % UT; 0.5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
0 % UT; 1 cycle
0 % UT; 1 cycle
Table 2
Guidance and manufacture’s declaration – electromagnetic immunity
This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is
used in such an environment.
Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transients/bursts
(EFT)
IEC 61000-4-4
Surges
IEC 61000-4-5
IEC 61000-4-11
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±2kV
100kHz repetition
frequency
line-to-line
±0.5kV, ±1kV , ±2kV
line-to-ground
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±2kV
100kHz repetition
frequency
line-to-line
±0.5kV, ±1kV,
±2kV
line-to-ground
270° and 315°
Floors should be wood, concrete or ceramic
tile. Humidity should be at least 30% if it is
synthetic materials.
Main power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be typical
commercial or hospital environment. UPS
power is recommended if this device needs
to be used continuously.
Voltage
interruptions
IEC 61000-4-11
RATED power
frequency
magnetic fields
IEC 61000-4-8
Note: UT is the A.C. mains voltage prior to application of the test level.
and
70 % U
T; 25/30 cycles
Single phase: at 0°
T; 250/300 cycle 0% UT;
0% U
30A/m
50Hz or 60Hz
and
70 % U
T; 25/30
cycles
Single phase: at 0°
250/300 cycle
30A/m
50Hz or 60Hz
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Power frequency
magnetic fields should be at levels
characteristic
of a typical location in a typical commercial
or
hospital environment.
Table 3
Pd 2.1=
Pd 2.1=
Pd 3
.2=
EPd /6=
at RF wireless communications equipment
bands (Portable RF communications
ing peripherals such as
Guidance and manufacture’s declaration – electromagnetic immunity
This equipment should be used in the electromagnetic environment specified below. User should assure that it is used
in such an environment.
Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150 kHz to 80 MHz
6Vrms
in ISM and amateur
radio bands between 150
kHz and 80 MHz (a)
10 V/m
80MHz to 2.7GHz
3Vrms
6Vrms
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any
parts than the recommended separation
distance that calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
150 kHz to 80 MHz
80MHz to 800 MHz
800MHz to 2.7GHz
equipment (includ
antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to
any part of the device).
Where “P” is the maximum output power
Note1: At 80MHz and 800MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
refection from structures, objects and people.
rating of the transmitter in watts according to
transmitter manufacturer and “d” is the
recommended separation distance in meters.
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
(b), should be less than the compliance level
in each frequency range (c).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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