Paingone KTR-2492 User manual

Thanks for choosing this product, please read this User Manual carefully before use!
your shield against back pain
User Manual
UK Enquiries：Tower Health Ltd.
www.tower-health.co.uk
Tel: [phone]
E-mail: [email protected]
Transcutaneous Electronic
Nerve Stimulator
20.12.09
L180 x W125mm
128G双铜纸/骑马钉编制审核批准产品名称CE版-说明书KTR-2492共24页骑马钉 4色印刷产品型号日期日期日期文件编号要 求页 码 尺 寸材 质颜 色产品名称
经皮电神经刺激器
paingone
Aegis
model:KTR-2492
Aegis
Fast, effective pain relie f
Distributed by:Quality Health Innovations Ltd, 1st Floor,
9 Exchange Place, I.F.S.C Dublin 1, D01 X8H2, Ireland.
[e-mail]

The following should not use Aegis:
Do not use Aegis in the following circumstances:
1. Patients with an implanted electronic device (for example a
cardiac pacemaker), unless specialist medical authorisation has
first been obtained.
2. Patients with suspected or confirmed epilepsy or heart disease,
malignant tumour, serious cerebrovascular disease or other acute
disease, unless specialist medical authorisation has first been
obtained.
3. Those who are or suspect they may be pregnant
4. Those with haemorrhage after acute trauma or fractures, or
those recovering from surgery
5. Those with skin particularly sensitive to heat or electrical
stimulation or with metal allergies
6. Children or people with no ability to express their own
consciousness.
1. On or near the heart, on the head, mouth cavity, genitals or
diseased skin
2. When skin is wet or humid, after showering or heavy sweating,
or while sleeping
3. On skin that is swollen (including phlebitis), infected or diseased
4. While driving or using heavy machinery
01
WARNINGS AND CONTRAINDICATIONS

Front View (Assembled)
Reverse View
Device Overview
Thank you for choosing Aegis. This guide will tell you how to
get started and how to get the most out of your device.
What is Aegis?
Aegis is a medical device that has been specifically designed to
help you target and manage back pain.
It delivers electrical stimulation (also known as “TENS”) straight to
the painful area. This blocks pain and stimulates the body’s own
natural pain relief mechanisms.
The device additionally delivers pleasant, massage-like stimulation.
Aegis can be worn discreetly under clothing and activated
whenever needed via the dedicated remote control.
Let Aegis be your shield against back pain and don’t let pain hold
you back!
Intended Use
Aegis is intended for the temporary relief of pain associated with
sore and aching muscles, specifically in the lower back, arising
from strain from exercise or normal household and work activities.
0302
paingone
Aegis
Aegis Unit
Power unit
Power button
Increase Intensity button
Decrease intensity button
LED light

Gel pads
Side A Side B
Electrode contacts Preparing Aegis before use
Remote Control
1. Attach gel pads to the Aegis unit
Remove one gel pad from its packaging. Remove the coloured
protective plastic cover from side A of the gel pad.
Apply the gel pad to the Aegis unit as shown in the diagram.
Now remove side B from the gel pad. Retain this plastic cover as it
will be re-used after treatment it coplete.
Now repeat the above process with the second gel pad.
05
04
Function/Mode
Intensity
Increase Intensity button
Decrease intensity button
Countdown Timer
Function/Mode button
Power button

Now press the power button on the remote control. Two beeps
will sound to indicate that the remote and the Aegis device are
paired.
4. Adjusting Intensity
Press the “+” button on the remote control repeatedly to increase
the intensity to a level you find comfortable. Alternatively, you can
use the buttons located on the power unit itself. If the intensity
becomes too strong, press the “–” button to reduce the strength of
the pulses.
The device will beep with each step up or down in intensity. There
are 16 steps of intensity in total.
5. Changing Functions and Modes
Aegis offers two main settings:
Automatic Function – This setting delivers combinations of
different frequencies and lengths of pulses
Manual Function – This setting allows you to select one specific
type of pulse.
Upon activation the device is automatically set to Automatic
function. The letter “A” displays in the upper left corner of the
screen.
Press the “F” (function/mode) button on the remote control quickly
to cycle through different combinations of pulses to find a mode
that you prefer. There are 6 modes in Automatic function.
Each time you switch Function or mode the device intensity will
reset to level “1”.
To switch to Manual function press and hold down the “F” button
on the remote control. The letter “M” will display in the upper left
corner of the screen.
Press the “F” button briefly to cycle through the pulse modes.
There are 9 pulse modes in Manual function.
2. Attach the power unit to the main unit
The power unit attaches to the main unit via two metal press studs.
Align the press studs, then push firmly until the control unit clicks
into place.
3. Applying Aegis
IMPORTANT: BEFORE USING AEGIS IT IS ESSENTIAL TO
WASH AND DRY THE AREA OF APPLICATION THOROUGHLY.
THIS WILL ENSURE THE DEVICE ADHERES CORRECTLY TO
THE SKIN. CLEANSING WIPES CAN ALSO BE USED FOR THIS
PURPOSE.
After cleansing and drying the skin, apply Aegis to the desired area.
Ensure that the gel pads are firmly pressed against the skin. A poor
connection will affect performance.
Press the power button on the power unit to activate the device.
A beep will sound and a green light will show.
0706

To return to Automatic function press and hold down the “F” button
once again.
6. Timer
Each session lasts for 15 minutes. The remaining minutes of the
session are displayed in the upper right corner of the screen on the
remote control.
The remote control will automatically turn off after the 15 minutes
have elapsed.
To begin another session simply re-activate the remote control, or
press the “+” intensity button on the device.
The maximum recommended number of consecutive sessions is 4
(60 minutes)
7. Powering off
To end a session before 15 minutes have elapsed, simply press the
power button on either the power unit or the remote control.
8. Safety mode / Power cut-out
If the gel pads lose full contact with the skin the pulse intensity will
automatically reduce to zero, as a safety feature. To re-commence
treatment, re-position the gel pads firmly against the skin and press
either the “+” or “–” buttons.
9. Storage
After use, remove Aegis from the body. Replace the plastic covers
over the gel pads to protect them until the device is used again.
Replacing the gel pads
Gel pads can be refreshed by wiping them with moistened fingers.
Allow to dry before using the device again.
When the gel pads have lost their stickiness completely, they
should be replaced with brand new gel pads.
Only use official Aegis gel pads with the Aegis device.
Only use one pair of pads per user of the device.
To purchase replacement gel pads contact Tower Health Ltd.
www.tower-health.co.uk
Tel: [phone]
E-mail: [email protected]
Recharging the battery
The power unit and the remote control are both powered by lithium
battery. These can be charged via the USB charging cable supplied.
The LED on the power unit will flash and a beep will sound to
indicate when recharging is required.
On the remote control, a battery symbol will appear in the upper
right corner of the screen to indicate that recharging is required.
Power unit charging time: Approximately 2 hours
Power unit battery life: Approximately 7 days, based on 15 minutes
use per day.
Remote Control charging time: Approximately 2 hours
Power unit battery life: Approximately 20 days, based on 15
minutes use per day.
Cleaning and maintenance
Keep the surface of gel pads clean. Avoid dust, oily matter and
viscous matter. These can cause the adhesiveness of the gel pads
to decline.
The control unit does not require maintenance or calibration. Do
not attempt to open the control unit for any reason. If a fault is
suspected, contact the point of purchase.
Storage
1) Keep Aegis out of reach of children
2) Do not store the device in places where it will be exposed to
direct sunlight, high temperature or moisture.
3) Store the device in a dry and ventilated space
09
08

Product disposal
Troubleshooting
7. Product Requirements and Major Parametric
Description
Product Power Requirement
a) Power source: Rechargeable lithium battery3.7v/100mAh
b) Device safety classes: class II type BF
Product Main Technical Parametric description
a)Impulse frequency:
TENS:20-100Hz
Problem Analysis of cause Recommended
Solution
In order to avoid environmental pollution, please dispose of Aegis
according to local environmental requirements. Do not discard in
your standard waste disposal.
The device does
not power up
correctly
The buttons are
not functioning
correctly
The device does
not emit any
"beep" sound
There is no
output (electrical
pulses) or the
output feels low
The battery is running
low or running out
The button is damaged
The battery is running
low or running out
The button is damaged
The speaker is
damaged
The battery is running
low or running out
The gel pad is
damaged or dirty, has
no stickiness or is
making poor contact
with the skin
Skin is too oily
Recharge the battery
Wipe the gel pad with
moist fingers. Allow to
dry before re-use.
Alternatively, replace
with a new gel pad
Wipe skin with a wet
towel or alcohol wipe.
Recharge the Battery
Contact the point of
purchase
Recharge the Battery
Contact the point of
purchase
Contact the point of
purchase
1110
The skin is
strongly
irritated/shows
signs of
redness
The treatment has
been applied too long
The intensity is set too
high
The gel pad is not
making good contact
with the skin
There may be an
allergic reaction to the
gel pad
The gel pad is dirty
Limit treatments to 15
minutes
Decrease the intensity
to a more comfortable
level
Press the gel pad
firmly against the skin
to improve contact
Cease use of the
device
Clean the gel pad
The device is damaged Allow to dry before
using the device
Contact the point of
purchase

■ The warning symbols and their glossary are intended to ensure
safe and proper use of the device by the user and prevent harm to
the user and others.
■The meaning of the warning symbols are as follows:
b)Pulse width:
TENS: 120µs
c)Impulse waveform: square wave
d)The product output has no the DC component.
e)Influence of output end open circuit and short circuit: it is able to
support the influence of output end open and short circuit, and its
performance will not be allowed to weaken.
f)Adjustment of output amplitude: 0-16 levels.
g)The timer of therapeutic equipment: 15 minutes.
h)Safety classification: internal electric source class and type BF
equipment
i)Boundary dimension:
Main unit : Model KTR-2492: Φ49.8*12.48
j)Product software version No.: A/0
k)Service life: the shelf life of subject device is 2 years; the use life
of the Electrode Pad is 80 times and shelf life is 2 years
Product Environmental Requirement
a)Normal work environmental requirements:
Environment temperature: +5℃-+40℃;
Environment humidity: 0%-80%RH;
Atmospheric environment conditions: 860hPa-1060hPa.
b)Storage environment requirements:
Environment temperature: -25℃-+55℃;
Environment humidity: 0-93%RH;
Atmospheric environment conditions: 500hPa-1060hPa.
c)Transport environment requirements:
Environment temperature: -25℃-+55℃;
Environment humidity: 0-93%RH;
Atmospheric environment conditions: 500hPa-1060hPa.
Indicates potential danger, injury or serious injury due to
incorrect usage
Indicates possibility of personal injury or damaged to goods
through incorrect usage.
-- To avoid burns or damaged apparatus The device must not be used
with Heart Fibrillation (HF) apparatus.
-- If the patient uses the therapeutic apparatus and HF apparatus at the
same time, the contact plate may cause burns, it may also damage the
apparatus. If the apparatus is used near (within 1 metre) of short-wave or
microwave therapeutic apparatus, the output of the device may become
unstable.
-- There is an increased risk of heart fibrillation if the electrode pads are
used close to the chest.
-- Do not modify this equipment without authorization of the manufacturer
--Do not attempt to replace the lithium batteries. Contact aftersales staff
designated and authorized by the manufacturer directly.
-- Battery replacement should only be attempted by professional
maintenance staff.
--The must not be used by people who can no longer take care of
themselves, with no ability to express their own consciousness, or
children.
Warning
attention
attention
Warning Sigh Meaning
Indicates potential danger, injury or serious injury due to
incorrect usage
Usage
contraindication
13
12
8. Safety Precautions

Accessories of Transcutaneous Electronic Nerve Stimulator, Models: KTR-2492
KTR-2491A
14 15
Usage Contraindications
⑴This device is contraindicated for those with a skin perceptual
disturbance or those unable to detect heat
⑵It is prohibited to use when bathing, sweating and sleeping.
⑶It is contraindicated for use by those with a purulent inflammation, acute
blood poisoning or continuous hyperpyrexia.
⑷It is contraindicated for use by those with acute cardiovascular or
cerebrovascular diseases.
⑸Please terminate use immediately and consult with a doctor if you
experience irritation of the skin during use.
⑴Pregnant women and menstruating women, people with sensitive skin,
heart disease, abnormal blood pressure, malignant tumors,
cerebrovascular patients, patients with acute disease or other persons
treated by a doctor must consult a doctor before using this product. ⑴Please do not use over the heart, on the head, eyes, front of neck
(especially the carotid artery), lower back, oral cavity or pudendum, or on
diseased skin
⑴Turn off the device if changing the area of application, otherwise there
is a risk of strong stimulation.
⑵If you feel unwell while using the product, please stop use immediately
and consult with a doctor if necessary
⑶Do not used in conjunction with other medical electronic devices, such
as cardiac pacemaker, artificial heart and lung and other medical
electronic devices such as electrocardiograph.
⑷Do not use the product in strong direct sunlight, or where there is high
heat, inflammable material, electromagnetic radiation and or high humidity.
⑸Do not disassemble, repair or modify the device. This risks damaging
the device and causing electric shock.
⑹The device should be placed in a position that is easily reached in case
it needs to be removed in an emergency
⑺Check the equipment before each use to avoid exposed wires caused
by accidental damage or other reasons.
⑻Dust may affect the performance of the unit, please use a dry soft cloth
to clean the device as needed.
⑼Please check whether the electrode is loose before each use, otherwise
it may have adverse effects on performance or cause other problems.
precautions
-- Simultaneous connection of a patient to high frequency surgical Medical
Electrical (ME) equipment may result in burns at the site of the stimulator
electrode pads and possible damage to the stimulator.
-- Operation in close proximity (e.g. 1 m) to a shortwave or
microwave therapy ME equipment may produce instability in the
stimulator output.
--Application of electrode pads near the thorax may increase the risk of
cardiac fibrillation.
-- Stimulation should not be applied across or through the head, directly
on the eyes, over the mouth, on the front of the neck, (especially the
carotid sinus), or from electrode pads placed on the chest and the upper
back or crossing over the heart.
--Prevent inhalation or accidental swallowing of small parts
-- Prevent sharp parts from damaging the product.
-- Do not use accessories not specified by the manufacturer.

2、IEC 60601-1-11：2015 Medical Electrical Equipment - Part
1-11: General Requirements For Basic Safety And Essential
Performance - Collateral Standard: Requirements For Medical
Electrical Equipment And Medical Electrical Systems Used In The
Home Healthcare Environment
3、IEC 60601-2-10：2013 Medical electrical equipment - Part
2-10: Particular requirements for the safety of nerve and
muscle stimulators
4、IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2:
General Requirements For Basic Safety And Essential
Performance - Collateral Standard: Electromagnetic Disturbances -
Requirements And Tests
The product conforms to the following standards and laws:
1、IEC 60601-1:2005+A1：2012 Medical electrical equipment-
Part 1: General requirements for basic safety and essential
performance
The equipment is intended for use in the electromagnetic
environment specified below. The customer or the user of the
EQUIPMENT should assure that it is used in such an environment.
The Transcutaneous Electronic Nerve Stimulator is suitable for
use in a professional health care environment, not including areas
where there are sensitive equipment or sources of intense
electromagnetic disturbances, such as the RF shielded room of an
imaging system magnetic resonance imaging, in operating rooms
near active AF surgical equipment, electrophysiology laboratories,
armored rooms or areas where short wave therapy equipment is
used.
-Do not use the system around strong electric filed,
electromagnetic filed (e.g. MRI scan room) and mobile wireless
communication devices. Using the device in an improper
environment may cause malfunction or damage.
-The compliance with EMC and EMI regulation cannot be
guaranteed by the use of modified cables or those which does not
comply with the same standards under what the equipment was
validated.
13. The Paraphrase of Graphic Symbol
14. Executive Standards
15. Appendix EMC Declaration
Symbol Explanation
Production Batch
Product catalogue reference code
Manufacturer
(Directive 93/42/EEC amended by Directive 2007/47/EC)
DATE OF MANUFACTURE. This symbol shall be
accompanied by a date to indicate the date of manufacture
Caution
Symbol for CE Mark. This symbol certifies that a product has met
European Union consumer safety, health, or environmental
requirements.
IP22
CE marking with the Registration Number of the Notified Body.
This denotes compliance with European Directive 93/42/EEC
concerning medical devices.
Refer to instruction manual/ booklet
Level of protection against the insertion of solid bodies of size
/diameter ≥ 12 mm and liquids in the presence of dripping water
when tilted at 15° compared with product.
0413Applied parts: BF type
European Authorized Representative
REF
1716

Table 1 Compliance class
Emissions
Test
Compliance Electromagnetic Environment and
Guidance
RF emissions
CISPR 11 Group 1 The equipment uses RF energy only for its
internal function.
Therefore, its RF emissions are very low and
are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11 Class B
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Complies
The equipment is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Table 2- Compliance standards
Phenomenon Basic
Standard of Immunity Test Level of
±8 KV contact
±2 KV, ±4 KV,
±8 KV,±15KV air
±8 KV contact
± 2 K V, ± 4 K V,
± 8 KV, ±15KV air
3V/m
80 MHz-2.7 GHz
80% AM at 1 KHz
3V/m
80 MHz-2.7 GHz
80% AM at 1 KHz
See table See table
±1 KV
100 KHz repetition
frequency
±1 KV
100 KHz repetition
frequency
Electrostatic
discharge
IEC 61000-4-2
Radiated RF
EM fields1
IEC 61000-4-3
Proximity
fields from RF
wireless
communication
equipment
IEC 61000-4-3
Electrical
Fast/Transients
bursts
IEC 61000-4-4
3V
0.15 MHz-80 MHz
6 Vm in ISM bands
between 0 .15 MHz
and 80 MHz
80% AM at 1KHz
3V
0.15 MHz-80 MHz
6 Vm in ISM bands
between 0.15 MHz
and 80 MHz
80% AM at 1KHz
Conducted
disturbances
induced by RF
fields.
IEC 61000-4-6
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Rated power
frequency
magnetic fields
IEC 61000-4-8
The following tables provide information on compliance of the
equipment according to the standard EN 60601-1- 2:2015.
1918
-The system must not be used adjacent or supported by other
equipment. The recommendations of this manual must be followed.
-Do not use accessories, transducers, internal parts of components
and other cables other than those previously specified by the
manufacturer. This may result in increased emission or decreased
electromagnetic immunity and result in improper operation.
-Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should by used no
closer than 30 cm to any part of the ultrasound system, including
cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
-To maintain basic safety in relation to electromagnetic
disturbances during the expected service life, always use the
system in the specified electromagnetic environment and follow the
maintenance recommendation described in this manual.

Table 3- Test specifications for ENCLOSURE PORT IMMUNITY to RF
wireless communications equipments
Test
Frequency
(MHz)
Band
(MHz)
Service Modulation Maximum
Power
(W)
Distance
(m)
Immunity
Test
Level
(V/m)
385 380-390 TETRA 400 Pulse
modulation
18 Hz
1.8 0.3 27
450
710
745
780
810
870
930
430-470
704-787
800-960
GSM
800/900,
TETRA 800 ,
iDEN 820,
CDMA 850,
LTE
5 Band
Pulse
modulation
18 Hz
LTE 13, 17
Band
GMRS 460,
FRS
460
FM ±5 KHz
deviation
1KHz sine
Pulse
modulation
217 Hz
2
2
0.3
0.30.2
0.3
0.3
28
28
9
1720
1845
1970
1700-1990
GSM 1800 ,
CDMA 1900,
GSM 1900,
DECT,LTE
1, 3, 4 , 25
Band, UMTS
Pulse
modulation
217 Hz 2 28
2450 2400-2570
Bluetooth,
WLAN
802.1 1 b/g/n,
RFID 2450,
LTE 7 Band
P u l s e
modulation
217 Hz
2 0.3
0.3
28
5240
5500
5785
5100-5800
WLAN
802.11 a/n
P u l s e
modulation
217 Hz
0.2 9
20 Well Kang LimitedThe Black Church, St. Mary’s Place, Dublin 7, D07 P4AX, Ireland[Tel]: [phone] [Fax]: [phone]
Shenzhen Kentro Medical Electronics Co.,Ltd 2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District, Shenzhen City, Guangdon Province, China[Tel]: [phone], [Fax]: [phone]