Welch Allyn 5300P Directions For Use

Directions for Use Chapter 7 Reference 73
Monitor Specifications
The monitor is an FDA Class II non-critical device and, according to Council Directive 93/
42/EEG, Annex IX, a Class IIB device.
Performance
Characteristic Specification
General
Recovery from Defibrillation
Discharge
Per IEC 60606-2-30:1999(E) The monitor returns to normal function within 1 minute after
the discharge of a cardiac defibrillator. (Actual recovery time = 0 seconds)
NIBP
Cuff Pressure Range 0 to 300 mmHg (0 to 40 kPa)
Initial Cuff Inflation
Factory Default
Adult 160 mmHg (21.3 kPa)
Pediatric 120 mmHg (16 kPa)
Neonate 90 mmHg (12 kPa)
Blood Pressure Accuracy • Blood pressure measurement meets or exceeds ANSI/AAMI
SP10: 2002 for manual, electronic, or automated
sphygmomanometers.
• Blood pressure accuracy is validated for pressure measurement
using the upper arm only, with the patient seated.
• Blood pressure is validated against manual auscultatory readings
for adults and children older than 3 years.
• Blood pressure is validated against intra-arterial readings for
children 3 years and younger.
Blood Pressure
Determination Time
20 - 45 seconds typical; 165 seconds maximum.
Overpressure Cutoff 295 to 330 mmHg (39.3 to 44 kPa)
Systolic Range Adult 30 to 260 mmHg (4 to 34.5 kPa)
Pediatric 30 to 160 mmHg (4 to x 21.3 kPa)
Neonate 25 to 120 mmHg (3.3 to 16 kPa)
Diastolic Range Adult 20 to 235 mmHg (2.7 to 31.3 kPa)
Pediatric 15 to 130 mmHg (2 to 17.3 kPa)
Neonate 10 to 105 mmHg (1.3 to 14 kPa)
MAP Adult 20 to 255 mmHg (2.7 to 30 kPa)
Pediatric 15 to 140 mmHg (2 to 18.7 kPa)
Neonate 10 to 110 mmHg (1.3 to 14.7 kPa)
Pulse Rate Range 30 to 220 bpm
Pulse Rate Accuracy ± 3 bpm or 3%
Note
NIBP specifications are tested by Welch Allyn using the BIO-TEK BP Pump NIBP
Monitor Tester.

Welch Allyn 5300P Specifications

General

Brand	Welch Allyn
Model	5300P
Category	Medical Equipment
Language	English