TECHNICAL FEATURES |
Electronic Generator, compliant with: IEC 601-1 and IEC 60601-2-2 Standards |
Classification 93/42 EEC: IIB |
Approval 93/42 EEC: 187 MDD-IMQ 0051 |
Electromagnetic Compatibility: Unit is compliant with IEC 60601-1-2,
Test report IMQ nr.80SF00709/1, 80SF00709/2 |
Classification and Type IEC 601-1: Class I, Type CF
Typical BF leakage currents: on the patient: 4 µA= 0.004mA,
into the enclosure: 1 µA= 0.001mA, to earth:30 µA= 0.3mA |
Output Circuit according to IEC 60601-2-2:“Floating” insulated at low and high frequencies, protected against the use of the defibrillator.
Typical high frequency leakage currents: 100mA. |
ALSA Quality System: Approved ISO 9001:2000 and ISO 13485:2003. |
Monopolar and bipolar working frequency: 440 kHz ± 5% |
Functioning Control System: with double microprocessor Master/Slave System with 2 32 bit-microprocessors with interconnection in feed-back with serial communication and double memorization of the functioning data with validity control CRC at 16 bit, which performs what follows: |
Auto-Check, complete self control of the hardware / software with: |
• Main Auto-Check main auto-diagnosis procedure at the switching on;
• Standard Auto-Check continuous auto-diagnosis during the whole functioning;
• • Immediate interruption of the functioning (in less than 100millisec) with contemporary alarm signal to the operators through specific Error Codes, when the auto-diagnosis systems find out some problems or failures about:
a) General Error Control, that is the general functioning or the activation errors;
b) Output Error Control, that is the delivery of the powers, in order to eliminate the risk of a sudden and dangerous output of a power which is higher than the selected one.
• Memorization of the 32 last Error Codes in order to facilitate the check and the technical assistance. |
Output Power Control, complete self regulation by microprocessors of the output powers through three different modes: |
• ADC System – constant power which automatically auto-adjusts the powers by verifying the voltage and the current, according to a continuous feed-back in real time (7,000 checks/sec) between the unit and the patient tissues, as well as between the electrode and its rapidity of sliding on the tissues. This system is also necessary to intervene in an efficacious way on many types of tissue or under liquid with the lowest possible powers; |
• APC System – constant voltage which automatically auto-adjusts the powers, by keeping the voltage – and so the currents electric arc – constant, according to a continuous feed-back in real time (7,000 checks/sec) between the unit and the patient tissues, as well as between the electrode and its rapidity of sliding on the tissues. This system is also necessary to intervene in an efficacious and very delicate way on the operating point with the minimum superficial necrosis; |
• Starting impulse control which electronically checks the starting pulse of the cut currents, in order to guarantee the maximum efficacy with the lowest possible powers. |
HF Leakage control, check of the high frequency leakage currents to earth:
The system, through a specific circuit, always verifies the leakage currents to hearth, and, just in case of dangerous situations, it keeps them within the safety limits, by automatically decreasing the output powers and by giving an alarm signal. |
Argon section Auto-Check, into the models Excell NHP-400/DA and Excell NHP-250/DA,complete auto-check of the Argon gas circuit.
At the switching on, the Argon section performs a complete auto-diagnosis on its circuit about what follows: mains supply, pressure, loss or absence of gas. |
Functioning memorization:
100 memorisable programs; among them, some pre-set programs for general or laparoscopic surgery, endoscopic surgery under liquid and flexible endoscopic surgery, as well as for the bipolar use only.
Into the models Excell NHP-400/DA and Excell NHP-250/DA, which are already equipped with the Argon gas functions, there are also pre-set programs for the usage in general or laparoscopic surgery and flexible endoscopy with or without the Argon gas. |
Micro/macro powers adjusting by push-buttons with low/fast changing and steps:
Monopolar:0/30W=1W, 30/100W= 2W, 100/200W=5W, da 200W=10W
Bipolar: 0/10W=0,5W, 10/30W=1W, 30/100=2W, da 100 W=5W |
Selected powers control: by displays. |
Outputs, activations
All the models are equipped with two monopolar outputs and two bipolar outputs
The two monopolar outputs can be used at the same time by two different operators with Twin activation device, as follows:
• Both of them by the double pedal foot-switch;
• Both of them by the hand switches placed on the electrodes holder handles;
• One by hand switches and one by the double pedal foot-switch.
250/DA, the two outputs can also be activated as follows:
• Both of them by the double pedal foot-switch: one for the electro-surgery, and one for the electro-surgery with Argon gas;
• Both of them by the hand switches placed on the electrodes holder handles: one for the electro-surgery, and one for the electro-surgery with Argon gas.
The two bipolar outputs can be always activated independently from the monopolar ones, through three modes:
• For the cut or the coagulation, by the double pedal foot-switch;
• For the coagulation, with the Micro Auto current, by the automatic Auto Start / Auto StopImpedance Sensing device and starting delay adjustable from 0 to 5 sec.
• For the coagulation / sealing of big vessels, with the Seal HC current, by the pedal foot-switch and automatic Auto Stop Impedance Sensing. |
Foot-switches
The Excell units can be equipped with:
• One double pedal foot-switch, selectable for the monopolar or bipolar functions;
• Two double pedal foot-switches: one for the monopolar functions, and one for the bipolar functions. The pedals are compliant with IEC 60601-2-2 Standard, and have an extra protection against the involuntary activation; they are waterproof (IPX7), and have a low tension supply for medical safety 12VDC. |
Neutral electrode safety circuit NPCC System
Complete control on the connection of the neutral electrodes “non split” type with one single section, and “split” type with double section.
With the “non split” electrodes, it checks the status of the cable and its connection.
• If the cable is broken/non well connected, the circuit interrupts the delivery of the power and gives a luminous acoustic alarm.
With the “split” electrodes, it also checks the contact between the electrode and the patient tissues.
• If only 80% of an adult standard electrode is well connected, the circuit gives a first luminous alarm signal. If the contact decreases to 50%, it gives another luminous alarm signal, and automatically reduces the output power to max. 200W. Finally, if the contact is dangerous or the cable is broken/non well connected, it interrupts the delivery of the power by giving a complete acoustic and luminous alarm signal. |
Colour codes and luminous or acoustic signals compliant with IEC 60601-2-2 |
Cut: hand switches or pedal foot-switches (yellow), activation (yellow light / low tone);
Coagulation: hand switches or pedal foot-switches (blue), activation (blue light / high tone);
Neutral electrode alarm: (red light / high and intermittent tone, not adjustable). |
|
Mains:230/115VAC± 10% ~ 50/60Hz |
Absorption at 230V: max power 3.6A=828VA, Stand-by 0.4A=92VA |
Enclosure: protected against the penetration of liquids, according to IEC 60601-1 |
Cooling: by convection, without fan |
Equipotential Connection: standard plug DIN 42801 |
Software Updating: through a serial port connected to a PC |
On-site Calibration: yes, special software |
Dimensions and Weight (LxDxH)
NHP 400/DA, NHP 250/DA: cm 38x38x16 – 16 Kgs
NHP 400/D, NHP 350/D, NHP 250/D: cm 38x35x16 – 15 Kgs |
Facility to use an external module for Argon gas
The models: NHP 400/D, NHP 350/D, NHP 250/D. |
Argon gas section (model Excell NHP 400/DA and Excell NHP 250/DA only)
Supply: both with 1 or 2 cylinders of 5lt. and with a centralized system; |
Max. flow and gas pressure: 15lt/min - input pressure: 2.5 atm; working pressure: 1 atm; |
Control of the flow through Constant flow System:from 1 to 15lt/min., through an electronic sensor with adjusting buttons, visual check on the bar-led, automatic auto-compensation according to the used electrode, and alarm just in case of absence of gas; |
Control of the pressure into the circuit Safety gas System: Reducer of the pressure on the cylinder; internal reducer of the pressure with safety valve; pressure sensor connected to the electronic control system with Auto-Check when the gas section is activated; |
Protection of the supplied gas flow: The output device for the gas is equipped with antibacterial filter. |