Synapse Accel-Heal Instruction manual

a Synapse electroceutical technology
General Instructions for Use
In addition, see product packaging for instructions specic to your device.
Electroceutical treatment for complex wounds
Accel-Heal® is a Class IIa registered medical device designed to accelerate healing in complex wounds using proprietary
electroceutical programs.
The Accel-Heal® treatment uses 6 single use devices used consecutively to deliver 12 days of treatment and is intended for use for
the treatment of complex wounds. The units may be used during sleep.
1. Clean the skin surrounding the wound with the alcohol
wipes included in the pack.
Attach the Accel-Heal® Unit to the electrode pads by
connecting the cables from the Accel-Heal® Unit to the
electrical leads from the electrode pads.
Do this by pushing the electrode connectors at the end
of the cables leading from the Accel-Heal® Unit into the
electrode receptors at the end of the electrical leads
leading from the electrode pads.
2. Press and hold button for 2 seconds to activate device. Activating the Program
When your nger is released the program will com-
mence its operation and the green LED will ash once
every two seconds. The program runs its specic
sequence after which time the device will turn itself
o. That’s it, it is that simple.
Connect the electrical leads from the electrode pads to
the cable ends from the Accel-Heal® Unit.
3. Flashing green light indicates activation.
Device will now run for 48 hours.
Stopping the Program Part-Way Through
If you wish to cease a program part-way through, the
device may be switched oby pressing and holding
down the on/obutton for 2 seconds. When the de-
vice is re-started a new program will start from
the beginning.
The following rules should be adhered to when using
a Synapse Electroceutical device.
Treatment Discomfort
Synapse Electroceutical treatments should be pain
free and sub-sensory (without feeling). However a
tingling sensation may be felt by some users and
is normal. If discomfort is experienced the device
should be switched oand the electrodes removed
immediately. Therefore, if in the unlikely event you do
feel increased pain or discomfort following use of the
device, please cease using it immediately and contact
your referring clinician. We strongly advise that the
electroceutical treatments will be more eective if you
are well hydrated, in addition, ensure the skin is clean
and dry before pad placement.
Skin Irritation
In the unlikely event that skin irritation develops
please stop using the Synapse Electroceutical device
and contact your clinician. Please do ensure that the
pads are clean prior to use.
Contra-indications Hazards
Your clinician should have explained the few con-
tra-indications for using the device; these are:
Heart Conditions
Consult your physician before using the Synapse Elec-
troceutical device if you have a heart condition and/or
have an implanted cardiac pacemaker.
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The program will now run its 48 hour sequence after
which time the unit will turn itself o. At this time
you should apply the next unit following the same
directions as above until the full course of treatment is
completed.
Attach the electrodes either side of wound or dressing
area.
Trouble Shooting
Problem: When there is poor contact between the
conducting electrode pads and the skin, the green ‘ON’
light/LED ashes more quickly at a rate of twice per
second.
Remedy: Clean the skin and reapply or use fresh pads.
Problem: The green ‘ON’ light will not light.
Remedy: The device has completed its treatment
course. Please return the device via the instructions
below.
Returning the Devices
Please dispose of used and decontaminated
devices in your organisation’s Waste Electrical and
Electronics Equipment (WEEE) disposal facility. Al-
ternatively, please contact Synapse Electroceutical
Ltd. on 01959 569433 to obtain a return envelope.
The devices will then be disposed of in an environ-
mentally sound manner. These devices are medical
electrical devices and should not be disposed of
with general waste. Devices will only be accepted
if accompanied with a decontamination certicate
or statement of decontamination. Devices can be
decontaminated by wiping them gently with 70%
isopropyl alcohol.
General Advice
The Synapse Electroceutical devices have been
developed as a result of signicant medical and sci-
entic research and they are intended to be used/
recommended for use by a medical or healthcare
clinician/practitioner following a consultation.

Emissions Test IEC 60601-
1-1
Test Level
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6 kV
contact
± 8 kV air
± 6 kV
contact
± 8 kV air
Floors should be wood,
concrete, or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should be
at least 30 %
Electrical fast
transient/burst
IEC 61000-4-4
Not
Applicable
Not Applicable
Not Applicable
Surge
IEC 61000-4-5
Not
Applicable
Not Applicable
Voltage dips,
short
interruptions
and
voltage
variations
on power supply
input lines
IEC 61000-4-11
Not Applicable Not Applicable
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 3 A/m 3 Power frequency magnetic
elds should be at levels
characteristic of a typical
location in a typical
domestic, commercial
or hospital environment.
Emissions Test Compliance Electromagnetic Environment Guidance
RF emissions
CISPR 11
Group 1 The device does not use RF for its 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
The device is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the low voltage power
supply network that supplies buildings used for
domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
uctuations/
icker emissions
IEC 61000-3-3
Not applicable
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
IEC 60601-1-2 for the Tendonworks and Accel-Heal® Devices
The device is suitable for use in the specied electromagnetic
environment. The customer and / or the user of the device should assure
that it is used in an electromagnetic environment as described below:
Guidance and Manufacturer’s Declaration
Electromagnetic Immdevicey
IEC 60601-1-2 Tendonworks and Accel-Heal® Devices
Immunity
test
IEC
60601
test
level
Compliance
level
Electromagnetic
environment – guidance
Conducted
RF
IEC 61000-
4-6
3Vrms
150kHz
to
80 MHz
3Vrms
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m). Field strengths from xed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range. Interference
may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
IEC 61000-
4-3
3 V/m
80 MHz
to
2,5 GHz
3 V/m
80 MHz
to
2.2 GHzw
Guidance and Manufacturer’s Declaration
Electromagnetic Immunity for Tendonworks and Accel-Heal® Devices
The device is intended for use in the electromagnetic environment
specied below. The customer and / or the user of the device should
assure that it is used in such an environment.
Immunity
test
IEC
60601
test
level
Compliance
level
Electromagnetic
environment – guidance
test If abnormal performance is observed
such as the device turning o, additional
separation distance or screening may
be necessary.
NOTE 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic propagation is
aected by absorption and reection from structures, objects and people.
Field strengths from xed 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 xed RF transmitters, an electromagnetic site
survey should be considered. If the measured eld strength in the location in which
the device is used exceeds the applicable RF compliance level above, the device should
be observed to verify normal operation. If abnormal performance is observed such as
the device turning o, additional measures may be necessary, such as reorienting or
relocating the device.
Over the frequency range 150kHz to 80MHz, eld strength should be less than 3V/m.
Rated maximum
output power of
transmitter
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
Not Applicable
80 MHz to
800 MHz
800 MHz to
1.4 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz the separation distance for the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is aected by absorption and reection from structures, objects and people.
Symbol Used Meaning
Caution
Keep Dry
Keep Out of Direct Sunlight
Temperature Limitation
Single Use Only - Do NOT Reuse
WEEE Directive 2002/96/EC Compliant
106kPa
50kPa Atmospheric Pressure Limitation
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Humidity Limitation
Type BF protection against electric
shock
Recommended Separation Distances
Between portable and mobile RF communications equipment
and the Tendonworks and Accel-Heal® devices
The device is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the
user of the device can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the device as
recommended below, according to the maximum output power of the
communications equipment.
Glossary of Symbols Used
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Manufactured by:
Synapse Electroceutical Ltd. UK
1 Churchill Court, Hortons Way,
Westerham, Kent TN16 1BT,
England, UK.
Tel: [phone]
Fax: [phone]
Email: [email protected]
www.accelheal.com
Revision No: 8 Date of Issue:28th September 2015
Pregnancy
There is no evidence to suggest that the Synapse Elec-
troceutical device would be detrimental to a healthy
pregnancy. However, based upon precautionary meas-
ures, we suggest that you consult your physician before
using the device.
Serious Disease
If you suer from a serious disease or condition such as
cancer we suggest you consult your physician before
using the device.
Epilepsy
If you suer from epilepsy we advise that you do not
use the device near the head.
Varicose Veins / Main Arteries
Do not place electrode pads directly over broken capil-
laries or varicose veins. We also advise that you do not
place electrode pads directly over main arteries such as
the carotid arteries in the neck.
Water
As with all electrical devices do not use the Synapse
Electroceutical device when bathing or if the device
becomes wet.
Children
The device and the accessories should be kept out of
the reach of children.
ECGs and other electrical devices
When the Synapse Electroceutical treatments are in
progress they may interfere with ECG and EEG monitors
and alarms.
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Interference
Please be aware there may be interference from other
electronic devices that aect the performance of the
Synapse Electroceutical device and it may aect other
electronic devices. If there are problems please switch o
the oending device or increase their separation distance.
Electrode Pads
We advise that you use electrode pads which comply with
MDD* safety standards (*Medical Device Directive). These
are available directly from Synapse Electroceutical Ltd.
No unauthorised extension leads, cables or attachments
should be used with the device.
Environmental Conditions for Transport, Storage and
Operation
Please ensure storage transportation and operation is
within 0°C ~ 45°C and less than 95% humidity.
Please ensure device is stored and transported between
50 -106 kPa
Please ensure device is operated between 70 - 106 kPa
Cleaning
For optimum performance always ensure that the Synapse
Electroceutical device is kept in a clean condition. We sug-
gest cleaning with a mildly damp cloth; ensure that water
does not penetrate the device.
For a comprehensive document covering hazards,
contra-indications and warranty please visit:
www.accelheal.com/support.html
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106kPa
50kPa