Mindray DPM 1, Operator'S Manual

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Specifications
1. General
1.1 Basics
Product Model: DPM1
Product Name: Pulse Oximeter
Classification:
IIb (According to MDD 93/42EEC directive)
II (21CFR 870.2700, 870.2710)
1.2 Safety Designations
Safety designations per IEC 60601-1 Standard:
Type of protection against
electric shock:
Internally powered equipment.
Degree of protection against
electric shock:
Type BF
Mode of operation: Continuous
Protection Against Ingress of
Liquid’s:
Not protected (Ordinary) - IPX0 per IEC60529
2. Parameter Specifications
The parameter specifications are applicable to the DPM1 Pulse Oximeter with sensors listed
in chapter 8 Accessories.
2.1 SpO
2
Range: 0% to 100%
Resolution: 1%
Accuracy:
70% to 100%:
±
2% (Adult, Pediatric)
70% to 100%:
±
3% (Neonate)*
0% to 69%: Unspecified
*Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO2 sensors
by contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age
of 22 weeks to full term were involved in this study. The statistical analysis of data of this study
shows the accuracy (Arms) is within the stated accuracy specification. Please see the following
table.
Sensor type Totally neonates Data Arms
518B 97 (51 male & 46 female) 200 pairs 2.38%
520N 122 (65 male & 57 female) 200 pairs 2.88%