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1.2.3
Regulatory Compliance
Designed to comply with Medical Electrical Equipment Standards (UL2601-1: 2000, IEC60601-1: 1995,
IEC60601-1-1: 2000, IEC60601-1-2: 2001, IEC60601-1-4: 2000, IEC60601-2-2: 1998, ANSI/AAMI
HF18: 2001).
Manufactured in an ISO 13485: 2003 Registered Facility.
Type of protection against electric shock: IEC Class 1.
Degree of protection against electric shock: Type CF, Defibrillator Proof.
Non-Ionizing Radiation.
1.2.4
Operation
Mode of operation: Intermittent 10 Sec on/30 Sec off.
1.2.5
Power Display Accuracy
The greater of ±10% of display or ±3 watts at rated load.
1.2.6
Line Regulation
Power Change <1%/V for the range of line voltages specified.
1.2.7
Environmental
Operating Conditions: 10°C to 30°C, 95% RH Non-condensing maximum.
Degree of protection against Ingress of Water: IPX1 (Protection against vertically falling water drops).
Mounting Restriction: 2-inch (5cm) clearance required on each side, back and above the ESU for cooling.
Cooling: Natural convection, conduction, radiation and temperature controlled fan.
Storage Conditions: -40°C to 70°C, at altitudes from –60 to +4500 meters above mean sea level when sealed
in original poly bag, packing material and shipping carton.
Prior to shipment or storage, the ESU should be enclosed and sealed in a polyethylene bag and placed in
original carton using original packaging materials.
RF Leakage: <100 mA per IEC60601-2-2: 1998, Clause 19.3.101b.
1.2.8
Contact Quality Monitor
Single dispersive electrode: Two wire continuity detector, typical trip threshold is 10 ohms
Dual dispersive electrode: Two wire resistance monitor, typical acceptance range 10 to 150 ohms, trip thresh-
old typically 30% higher than initial activation, visual indication of patient resistance changes.
1.2.9
Audio Specifications
Cut = 520 Hz
Coag = 440 Hz
Bipolar = 440 Hz
Acc Fault = 847 Hz (pulsating)
Dispersive Electrode Alarm = 847 Hz (pulsating)
Err Fault = 847 Hz (pulsating)
Increase Power Level = 379 Hz
Decrease Power Level = 343 Hz
(All tones are 45 dbA minimum except Alarms, which are 65 dbA minimum)
1-10
Enter Cut Remote Power Control = 440 Hz fol-
lowed by 574 Hz
Enter Coag Remote Power Control = 440 Hz
followed by 515 Hz
Bipolar Output Tone = 215 Hz
Pulse Cut Activation Tone = 520 Hz with peri-
odic short pulses at 481 Hz during output power
pulses
Pulse Coag Activation Tone = 440 Hz with peri-
odic short pulses at 384 Hz
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