background image

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

C

M

Y

CM

MY

CY

CMY

K

FK-F_IFU-US_8C-R1_aw.pdf   2   05/08/2014   09:50

Summary of Contents for Firefly T-1

Page 1: ...uctions for Use before applying the firefly T 1 device 1 0 firefly T 1 device 1 1 Description of firefly T 1 device The firefly T 1 device is a small disposable internally powered neuromuscular stimulation device for muscle conditioning It is an integrated device and there are no additional cables or electrodes required for its operation Familiarize yourself with the components before you use the ...

Page 2: ...uctions for Use before applying the firefly T 1 device 1 0 firefly T 1 device 1 1 Description of firefly T 1 device The firefly T 1 device is a small disposable internally powered neuromuscular stimulation device for muscle conditioning It is an integrated device and there are no additional cables or electrodes required for its operation Familiarize yourself with the components before you use the ...

Page 3: ...ession 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 hydro...

Page 4: ...ession 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 hydro...

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