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: 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.
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