fault indication
the stimulator device will
automatically switch off for over
current, under current, low battery
voltage or end of 30 hour run time
standards
IEC60601-1 (1996), IEC60601-2-10
(2001), IEC60601-1-2 (2001),
ISO10993
Operating conditions:
temperature range
10°C to 30°C
humidity range
10% to 80% non-condensing
Storage conditions in original packaging:
temperature range
-10ºC to 30ºC
humidity range
10% to 80% non-condensing
shelf-life
see expiry date on the pouch label
Transport conditions:
temperature range
-10°C to 40°C
humidity range
10% to 80% non-condensing
materials
soft moulding: TPE
Hydrogel cover: PET (Mylar)
polyethylene terephthalate
warranty
check expiry date on pouch before
use and 24 hours stimulation
INST
SK
Y8C/R1
T-1
T-1
instructions for use
specifications
Firstkind Limited*
Hawk House, Peregrine Business Park, High Wycombe,
Buckinghamshire, HP13 7DL, United Kingdom
T: +44 (0)1494 572040
To find out more about firefly™ T-1 device visit:
www.fireflyrecovery.com
firefly™ and OnPulse™ are registered trademarks of
Sky Medical Technology Limited.
* Firstkind Ltd is a wholly owned subsidiary of Sky Medical
Technology Limited.
This product is covered by granted and pending patents.
©2014 Sky Medical Technology Limited.
product name
firefly™
model reference
T-1
product type
powered muscle stimulator
class
BF
dimensions
149mm x 42mm x 11mm
weight
18g (firefly™ T-1 device only)
power source
internally powered equipment, battery
not replaceable
battery
primary lithium coin cell
operation
continuous operation
– equipment not suitable for use in
presence of flammable anaesthetic
mixture with air or with oxygen or
nitrous oxide
stimulation modes 7 (selectable pulse widths)
pulse current
27mA (±15%) constant current,
compliance to 80v
load impedance
200Ω to 3kΩ for 27mA output
pulse voltage
set by current and load
pulses width
70, 100, 140, 200, 280, 400 and 560µs
(200Ω to 10kΩ)
(±5% +20µs) (open circuit ±5% +70µs)
repetition rate
1Hz (±5%)
maximum charge
20µC per pulse
net charge output
zero per cycle
output coupling
ceramic capacitor
current rms (500Ω) 1mA rms maximum
voltage rms (500Ω) 0.5V rms maximum
operating time
24 hour duration (maximum 30 hours)
indicator display
green LED, flashing
repetition rate: 1Hz
pulse width
pulse width
voltage
voltage waveform:
current waveform:
repetition rate: 1Hz
pulse width
pulse width
current
output voltages and currents:
measured at internal outputs of the pulse generator (±15%)
pulse width half-power setting
280µs
full-power setting
560µs
load
current voltage
current voltage
200Ω
500Ω
1000Ω
2000Ω
3000Ω
open circuit
27mA
27mA
27mA
27mA
27mA
0
5.4V
13.5V
27V
54V
81V
80 to 160V
27mA
27mA
27mA
27mA
27mA
0
5.4V
13.5V
27V
54V
81V
80 to 160V
continued from overleaf
to Firstkind Limited by dialling 011 44 1494
572040 or log-on at:
http://www.fireflyrecovery.com/contact-us
Discontinue use of the firefly™ T-1 device until
further investigations have been carried out.
7.0 About the firefly™ T-1device and
muscle stimulation
7.1 The physiology
The body’s circulatory system serves to transport
and distribute essential substances to the tissues
of the body and to remove by-products of
metabolism, both of which are important for
recovery after intensive exercise. It also plays a
role in the regulation of body temperature,
humoral communication throughout the body
and adjustments of oxygen and nutrient supply in
differing physiological states. The cardiovascular
system is made up of a pump (the heart), a series
of distributing and collecting tubes and an
extensive system of thin vessels that allow rapid
exchange with tissues. An average adult has a
blood volume of about 5-6 litres. The venous
system has a large capacity and may contain
some 70% of the blood volume at any time with a
large percentage of this in the lower legs. Cardiac
output is the volume of blood pumped by the
heart per minute and venous return is the volume
returning to the heart in the same unit of time.
These are interdependent and multiple feedback
control loops operate to regulate the
cardiovascular system. Ancillary factors can affect
venous return including muscular activity.
Contraction of the muscles causes intermittent
venous compression and, because of the
orientation of the venous valves, blood is forced
from the veins toward the heart. The muscle
contractions can be the result of physical
activities, but can also be elicited by external
electrical stimulation.
Muscular contraction in the lower limb lowers the
mean venous pressure and serves as an auxiliary
pump to assist venous return. Muscle contraction
lowers capillary hydrostatic pressure and
increases local blood circulation.
7.2 How firefly™ T-1 device works
The firefly™ T-1 device is a small disposable,
internally powered, neuromuscular stimulation
device for muscle conditioning. Specifically, the
firefly™ T-1 device is intended to be used
following intense exercise to facilitate muscle
recovery. It is self-adhesive and is applied to the
outside of the knee, wrapping around towards
the back of the knee. This positioning enables the
firefly™ T-1 device electrodes to apply a stimulus
to the common peroneal nerve, which runs down
the back of the knee and down the side of the
lower leg (see Fig. 2 & 3), causing mild contraction
of the calf and foot muscles without affecting
mobility or other normal movements of the lower
leg. Contraction of the calf muscles will boost
blood flow from the lower limbs back to the heart,
thus increasing venous return and local blood
circulation. The increased blood flow resulting
from use of the firefly™ T-1 device has been shown
to improve recovery from muscle soreness in the
lower legs following intense exercise. The firefly™
T-1 device has seven stimulation levels. It is fully
insulated by the protective moulding and there is
no risk of electric shock.
7.3 The user experience
The application of the firefly™ T-1 device is very
simple and you will only experience a cooling
effect as the area of skin, to which the device will
be applied, is cleaned. Thereafter, you will feel as
if a small adhesive patch has been applied to
the skin.
Upon switching on the firefly™ T-1 device and
selecting the appropriate stimulation level (see
fitting and operating instructions below), you will
be aware of the muscle contraction, but this
awareness usually recedes slightly after a few
minutes as you become used to the feeling. This
is called “accommodation”.
For optimal results, you should apply the firefly™
T-1 device within 1 hour after exercise, and wear
the firefly™ T-1 device for as long as possible, but
not more than 24 hours. You should be able to
carry out your normal routine while wearing the
firefly™ T-1 device, including sleep. Be sure to
remove the firefly™ T-1 device if you need to
shower or bathe.
8.0 Disposal of the firefly™ T-1 device
The firefly™ T-1 device is not reusable after its 24
hour operating period. The used device should
be disposed of safely.
The firefly™ T-1 device is powered by a lithium
coin battery located inside the protective
moulding. Do not remove the battery from the
firefly™ T-1 device. Dispose of the entire firefly™
T-1 device after use in the normal, municipal
waste or follow local or State procedures for
battery disposal, if applicable.
DO NOT INCINERATE.
9.0 Help
If you require any help with the use of the firefly™
T-1 device, contact Firstkind Limited by dialling
011 44 1494 572040 or log-on at
http://www.fireflyrecovery.com/contact-us
Muscles extend
into foot
Tibialis anterior
Extensor digitorum
longus
Tibialis anterior
Extensor
digitorum longus
Extensor hallucis
longus
Peroneus tertius
fig. 2
Anterior muscle
engagement
Peroneal nerve
Muscles extend
into foot
Peroneus longus
Peroneus brevis
Extensor hallucis longus
Extensor digitorum
brevis
Peroneus tertius
Peroneus longus
Peroneus brevis
fig. 3
Lateral muscle
engagement
explanation of the meaning of symbols
single use only
do not re-use
expiry date
do not use after the adjacent number
type BF
applied part, suitable for direct electrical contact
to user but not for direct cardiac application
refer to instructions for use
lot number
the adjacent number is the lot number used for
traceability
attention
read instructions before use
+
-
transport and storage temperature
the device must be stored or transported at a
temperature between the indicated range
not made with natural rubber latex
manufactured by
the firefly™ T-1 device is manufactured by
Firstkind Ltd, a wholly owned subsidary of Sky
Medical Technology Ltd
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