Physio Control LIFEPAK 15, Operating Instructions Manual

Page: 235 / 284

Appendix A | Specifications and Performance Characteristics
©2007-2015 Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillator Operating Instructions
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ENVIRONMENTAL—Unit meets functional requirements during exposure to the following
environments unless otherwise stated.
Operating Temperature 0° to 45°C (32° to 113°F)
-20°C (-4°F) for 1 hour after storage at room temperature
60°C (140°F) for 1 hour after storage at room temperature
Storage Temperature -20° to 65°C (-4° to 149°F) except therapy electrodes and batteries
Relative Humidity,
Operating
5 to 95%, non-condensing
NIBP: 15 to 95%, non-condensing
Relative Humidity,
Storage
10 to 95%, non-condensing
Atmospheric Pressure,
Operating
-382 to 4,572 m (-1,253 to 15,000 ft)
NIBP: -152 to 3,048 m (-500 to 10,000 ft)
Water Resistance,
Operating
IP44 (dust and splash resistance) per IEC 60529 and EN 1789 (without
accessories except for 12-lead ECG cable, hard paddles, and battery
pack)
Vibration MIL-STD-810E Method 514.4
Propeller Aircraft - category 4 (figure 514.4-7 spectrum a)
Helicopter - category 6 (3.75 Grms)
Ground Mobile - category 8 (3.14 Grms)
EN 1789: Sinusoidal Sweep, 1 octave/min, 10-150 Hz, ±0.15 mm/2 g
Shock (drop) 5 drops on each side from 18 inches onto a steel surface
EN 1789: 30-inch drop onto each of 6 surfaces
Shock (functional) Meets IEC 60068-2-27 and MIL-STD-810E shock requirements
3 shocks per face at 40 g, 6 ms half-sine pulses
Bump 1000 bumps at 15 g with pulse duration of 6 msec
Impact, Non-operating IEC 60601-1 0.5 + 0.05 joule impact
UL 60601-1 6.78 Nm impact with 2-inch diameter steel ball
Meets IEC 62262 protection level IK04
EMC IEC 60601-1-2 Medical Equipment - General Requirements for Safety
- Collateral Standard: Electromagnetic Compatibility - Requirements
and Tests
Cleaning Cleaning 20 times with the following: Quaternary ammonium,
isopropyl alcohol, hydrogen peroxide
Chemical Resistance 60 hour exposure to specified chemicals:
Betadine (10% Povidone-Iodine solution)
Coffee, Cola
Dextrose (5% Glucose solution)
Electrode Gel/Paste (98% water, 2% Carbopol 940)
HCL (0.5% solution, pH=1)
Isopropyl Alcohol
NaCl solution (0.9% solution)
Cosmetic discoloration of the paddle well shorting bar shall be
allowed following exposure to HCL (0.5% solution).