XFT MEDICAL 2001EA User Manual

XFT-2001EA

G4 Foot Drop System
User Manual

Caution: Federal law restricts this device to sale by or on the order of a pra ctitioner licensed by the law of the State in which
he/she practices to use or order the use of the device.

Content

1. For Your Health and Safety ............................................................................................................................................................. 3

2. Overviews ....................................................................................................................................................................................... 8

3. Product Illustration.......................................................................................................................................................................... 9

4. Operation Instruction .................................................................................................................................................................... 12

5. Attentions ...................................................................................................................................................................................... 17

6. Care and Maintenance ................................................................................................................................................................... 17

7. F AQ & Troubleshooting................................................................................................................................................................ 18

8. Product Configuration ................................................................................................................................................................... 18

9. Product classification .................................................................................................................................................................... 19

10. After-sales Service ...................................................................................................................................................................... 20

1. For Your Health and Safety

Declaration of conformity according to the applicable European

 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 cause acci de nt / physical discomfort

Type BF Equipment

Use with Caution

Non-ionizing radiation

Date of manufacture

Manufacturer

Serial Number

directives and number of the notified body (0123)
European Authorized Representative

Consult instructions for use

Please dispose of the device/battery/accessory/packing in accordance
with the legal obligation in your area

Contraindications

 Powered muscle stimulators should not be used on patients with cardiac demand pacemakers.
 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.
 Do not touch the charging connector/battery and the patient simultaneously when charging/using.

Warning

 The long-term effects of chronic electrical stimulation are unknown.
 Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the

carotid sinus reflex.

 Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur

and the contractions may be strong enough to close the airway or cause difficulty in breathing.

 Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause

cardiac arrhythmias.

 Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis,

varicose veins, etc.

 Stimulation should not be applied over, or in proximity to, cancerous lesions
 The safety of usage durin g p regnancy or menstruation has not been determined.
 Electrode positioning and stimulation parameters’ setting should be conducted by professionals. If you keep feeling pains or

rash, please stop using 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 situations:

– Bleeding trend caused by serious trauma;
– Muscle training might cause disorder of rehabilitation of a recent surgery;
– Electrode positionin g 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.

2

 Please use with caution when the output current de ns i ty 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.

Precautions

 Safety of powered muscle stimulators for use during pregnancy has not been established.
 Caution should be used for patients with suspected or diagnosed heart problems.
 Caution should be used for patients with suspected or diagnose d epi lepsy.
 Caution should be used in the presence of the following:

a. When there is a tendency to hemorrhage following acute trauma or fracture;
b. Following recent surgical procedures when muscle contraction may disrupt the
c. healing process;
d. Over the menstruating or pregnant uterus; and
e. Over areas of the skin which lack normal sensation.
 Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive

medium. The irritation can usually be reduced by using an alternate conductive medium, or alternate electrode placement.

 Electrode placement and st i mulation settings should be based on the guidance of the prescribing practitioner.
 Powered muscle stimulators should be kept out of the reach of children.
 Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
 Powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which

involuntary muscle contractions may put the user at undue risk of injury.

Adverse Reactions

Skin irritation and burns beneath the electrodes have been re p or t ed with the use of powered muscle stimulators.

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

EMC in this manual.

Caution: This section will list the contents described in the YY0505-2012 form. It is the responsibility of the user to

ensure that this equipment and its nearby equipment meet the RF interference parameters indicated in the general safety
requirements.

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.

such an environment.

This equipment uses RF energy only for its internal function. Its RF

nearby electronic.

CISPR 11

This equipment is suitable for domestic establishments and those

IEC 61000-3-2

IEC 61000-3-3

±1kV diffe re ntial mode

±1kV differential

voltage variations

<5% UT (>95% dip in

<5% UT (>95% dip

Table 1
MANUFACTURER’S DECLARATION-ELECTROMAGNETIC EMISSION

This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is used in

Emissions test Compliance Electromagnetic

Environment - Guidance

RF emissions,
CISPR 11

Group 1

emissions are very low and are not likely to cause any interference in

RF emissions,

Class B

directly connected to the public low-voltage po wer supply network.

Harmonic emissions,

Voltage fluctuations/flicker

Class A

Complied

emissions,

Table 2
MANUFACTURER’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.

Immunity test IEC60601 test level Compliance Guidance
Electrostatic

discharge (ESD)
IEC 61000-4-2
Electrical fast

±6kV contact
±8kV air

±2kV power lines

±6kV contact
±8kV air

Floors should be wood, concrete or ceramic tile.
Humidity should be at least 30% if it is synthetic
materials.

±2kV power lines Main power quality should be that of a typical
transient burst
(EFT)

±1kV I/O electric cable
(length>3m)

IEC 61000-4-4
Surge
IEC 61000-4-5

±2kV common mode

mode

±2kV common

mode
Voltage dips,

short
interruptions and

UT) 0.5 cycle
40% UT (60% dip in
UT) 5 cycle

IEC 61000-4-11

70% UT (30% dip in
UT) 25 cycle
<5% UT (>95% dip in

Power frequency

UT) 5s
3 A/m 3 A/m Power frequency

in UT) 0.5 cycle

40% UT (60% dip

in UT) 5 cycle

70% UT (30% dip

in UT) 25 cycle

<5% UT (>95% dip

in UT) 5s

(50/60Hz)

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.

magnetic fields should be at levels characteristic

IEC 61000-4-8

of a typical location in a typical commercial or
hospital environment.

Note: UT is the A.C. mains voltage prior to application of the test level.

Table 3
MANUFACTURER’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 Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3

3 Vrms
150k~80MHz
3 V/m
80M~2.5GHz

3 Vrms Portable and mobile RF communications

equipment should be used no c l os e r to any parts

3 V/m

than the recommended separation distance that
calculated from the equation applicable to the
frequency of the transmitter. Recommended
separation distance:

d = 1.2√p
d = 1.2√p 80MHz to 800 MHz
d = 2.3√p 800MHz to 2.5GHz

Where “p” is the maximum output power 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 a)
should be less than the compliance level in each
frequency range b) interference may occur in the
vicinity of equipment marked with the following
symbol:

Note1: at 80MHz~800MHz, the higher frequency range applies.
Note 2: these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refection

from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which this is used exceeds the applicable RF compliance level above , this
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating.

b) Field strengths should be le s s than 3V/m in the frequency range o f 1 50k~80MHz.