Internal Defibrillation Perfected

Internal Defibrillation Perfected
The system includes the sterile PulseOneTM (+), a lightweight single hand-held positive contact designed with
an ingenious 360° pivoting head. It delivers shocks exactly where needed without manipulating the heart.
The negative contact pad, the PulseOneTM (-), is placed on the patient’s back.
Together, the system provides a better, safer, easier-to-use method for internal
defibrillation.
What’s more this system is completely disposable.
Always ready. Always reliable. Take a look at the benefits the PulseOne™ System offers:
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One-handed operation - Better, safer and
easier to use
360° pivoting head - Enables shocks to be
delivered exactly where needed, no matter what
the angle or positioning… without ever
manipulating the heart
Safer - Negative pad on the patient’s back is far
removed from the hand-held conductor, virtually
eliminating the risk of sparking and burning
Superior patient outcomes - Proven results from
thousands of patients at a highly esteemed
university hospital in Belgium
Lightweight - Ease of use and flexibility
Completely disposable - Eliminates the risk of
cross contamination with no clean up or
sterilization. Immediately ready to perform when
needed
Cost effective - Save time and money
The new way of internal defibrillation in your hand
 SAFETY FEELS GOOD

www.innomediq.com . [email protected]
Nieuwlandlaan 1c, BE 3200 Aarschot
Tel.: +32(0)16 25 26 90 . Fax: +32 (0)16 57 25 90
The PulseOne
TM
System
Internal Defibrillation Perfected
Electrical Specifications: PulseOne™ System
 Therapy energy range: 50 Joules maximum
 Internal paddle identification: defibrillator
limits energy to 50 Joules - to be used
with the PulseOne(-)™ Disposable External
Pad (placed on patient to complete circuit)
 Therapy waveform compatibility:
monophasic
or biphasic truncated exponential
 Peak operating voltage: 1700 Volts
 Peak operating current: 85 Amps
 Maximum discharge rate: 1 minute
duration – 6 cycles/min.
 Service life: 20 cycles @ 50 Joules
 Paddle dielectric withstand: 3500 VDC
 Wire dielectric withstand: 3500 VDC
 IEC Type: CF applied part
Physical Specifications
 PulseOne(+)™ weight: 0.112 kg
 PulseOne(+)™ overall length: 22.58 cm
 Cable length: 3.048 m
 Termination: 4mm plug with red square
shroud
 PulseOne(-)™ Adult/Pediatric total area
144 cm square
 PulseOne(-)™ Cable length 2.4m
PulseOne(-)™ Termination 4mm plug with
black round shroud
Environmental Specifications
 Operating temperature: 0ºC to 50ºC
(32ºF to 122ºF)
 Storage temperature: -20ºC to 55ºC
(4ºFto 131ºF)
 Storage humidity: 15% to 80%
 Storage altitude: 0 to 4.57 km
(0 to15,000 ft.)
 Operating altitude: 0 to 4.57 km
(0 to15,000 ft.)
 Shock: no functional damage following
0.9 m (3ft.) drop
Package Specifi cations
 Disposable, single-patient-use
 PulseOne(+)™ 1 Disposable Sterile
Internal Contact per package
 PulseOne(-)™ 1 per pouch, 10 per box
 Shelf life: 2.5 years
Regulatory Standards: Meets applicable
portions of the following standards:
ANS/AAMI DF80:2003 Medical electrical
equipment
EN ISO 10993-1:1997 Biocompatibility
EN60601-1:1990 Medical Electrical
Equipment,
General Requirements for Safety
EN60601-1-2:2001 Medical Electrical
Equipment, General Requirements for
Safety
Collateral Standard:
Electromagnetic Compatibility –
Requirements and Tests
EN60601-2-4:2003 Particular Requirements
for the Safety of Cardiac Defibrillators
PulseOneTM System
Adapter Specifications
Electrical Specifications:
 Peak operating voltage:400mA
32VAC –100mA 50VDC–125mA 12VAC
 Initial contact resistance: 50 mΩ max.
 Insulation resistance: 1 GΩmin. At
500VDC
 Dielectric strength: 1,000 VAC rms
 Electrical life at full load: 500,000 cycles
 Mechanical life: 1,000,000 cycles
 Operating force: 2N to 5N
Physical Specifications
 Weight: 3.85 oz.
 Overall length: 9.4in
 Non-sterile
 Latex Free
 Materials:
1.Internal case: thermoplastic UL94-V0
2.External case: ABS plastic
3.Plunger: polyamide 6/6
4.Bushing/bezel: polyamide 6/6
5.Contacts: silver, gold plated
6.Terminal seal: epoxy
Environmental Specifications
 Operating temperature: -40º C to +85º C
 Salt spray: IEC 512-6, test 11f
 Vibration resistance: 10-500 Hz – 10 g
according to IEC 512-4, test 6d
 Shock resistance: 100 g according to IEC
512-4, test 6c
 Degree of protection: IP 67
PulseOne™ System Adapters
Adapter plug for use with:
Mindray D3 / D6
Mindray D3
Custom adaptors available upon request.