Mindray BeneHeart D20 User Manual

A - 17
Nellcor SpO
2
Module
A.8.5 PR Specifications
PR from Mindray SpO
2
Module
PR from Masimo SpO
2
Module
Refreshing rate ≤1 s
SpO
2
averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
Low perfusion conditions Pulse amplitude: >0.02%
Light penetration: >5%
Low perfusion SpO
2
accuracy
2
±2%
PI measurement range 0.02 to 20%
1
The Masimo pulse oximeter with sensors have been validated for no motion accuracy in human blood studies on healthy
adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses
68% of the population. One percent was added to the accuracies for neonatal sensors to account for accuracy variation due
to properties of fetal hemoglobin.
The Masimo pulse oximeter with sensors has been validated for motion accuracy in human blood studies on healthy adult
volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to
2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of
70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard
deviation. Plus or minus one standard deviation encompasses 68% of the population.
2
The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2
simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for
saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
Standard Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Response time ≤30 s (normal perfusion, no disturbance, SpO
2
value sudden change from
70% to 100%)
Accuracy 70% to 100%:
70% to 100%:
0 to 69%:
±2%ABS (adult, pediatric)
±3%ABS (neonate)
not specified
Refreshing rate ≤1 s
When the SpO
2
sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by ±1%, to
compensate for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood.
Measurement range 20 to 300 bpm
Resolution 1 bpm
Response time <30 s (normal perfusion, no disturbance, PR value sudden changes from 25
to 220bpm)
Accuracy ±3 bpm
Refreshing rate ≤1 s
Measurement range 25 to 240 bpm
Resolution 1 bpm
Response time ≤20 s (with normal perfusion, no disturbance, and a PR value transition from
25 to 220 bpm)

Mindray BeneHeart D20 Specifications

General

Model	BeneHeart D20
Connectivity	USB
Operating Temperature	0°C to 50°C
Energy Levels (Pediatric)	50J
Analysis Time	<10 seconds
Monitoring Parameters	ECG
NIBP Measurement	Not available
SpO2 Measurement	Yes
Temperature Measurement	Not available
Voice Prompts	Yes
CPR Guidance	Yes
Data Recording	Yes
Data Transfer	USB
Battery Type	Lithium-ion battery
Storage Temperature	-20°C to 60°C

Summary

1 Safety

1.1 Safety Information

Details general safety guidelines, including DANGER, WARNING, CAUTION, and NOTE classifications.

1.1.1 Dangers

Highlights immediate hazards that can cause death or serious injury if not avoided.

2 Equipment Overview

2.1 Intended Use

Defines the intended purpose and applications of the medical equipment.

2.1.1 Intended Purpose Statement

Specifies the equipment's intended functions: defibrillation, cardioversion, pacing, and monitoring.

2.1.2 Indication for Use

Lists the specific medical conditions and patient types for which each function is indicated.

2.1.3 Intended Users

Identifies the qualified medical personnel responsible for operating the equipment.

3 Equipment Preparation

2.1.6 Contra-indications

Specifies conditions where AED and Manual Defibrillation modes should not be used.

2.2 Applied Parts

3.1 Equipment Preparation Safety Information

Provides critical safety warnings and cautions for setting up the equipment before use.

4 Therapy Preparation

3.2 Connecting the Power Supply

Details procedures and safety precautions for connecting the equipment to a power source.

4.1 Checking the Patient Contact Indicator

5 AED

5.1 AED Safety Information

Covers safety precautions, dangers, and warnings specific to Automated External Defibrillator (AED) use.

5.2 AED Procedure

Outlines the step-by-step procedure for using the AED function, including pad placement.

6 Manual Defibrillation

6.1 Manual Defibrillation Safety Information

Details safety information, dangers, warnings, and cautions for manual defibrillation operations.

6.2 External Defibrillation Procedure

Describes the procedures for external defibrillation using electrode pads and paddles.

6.3 Internal Defibrillation Procedure

7 CPR Assistance

6.4 Synchronized Cardioversion

6.4.1 Synchronized Cardioversion Procedure

Details the steps for performing synchronized cardioversion and shock delivery.

7.1 CPR Assistance Safety Information

Provides safety guidelines and warnings for using the CPR assistance features.

8 Noninvasive Pacing

7.2 CPR Metronome

8.1 Pacing Safety Information

Covers crucial safety information, warnings, and cautions for noninvasive pacing.

10 Alarms

10.1 Alarm Introduction

10.2 Alarm Safety Information

Provides essential safety warnings and precautions related to alarm configuration and management.

11 Monitoring ECG

12 Resting 12-Lead ECG Analysis

11.1 ECG Safety Information

Covers safety warnings and precautions related to ECG monitoring.

13 Monitoring Respiration (Resp)

11.3 Preparing for ECG Monitoring

11.3.1 Preparing the Patient for Electrode Application

14 Monitoring Pulse Oxygen Saturation (SpO2)

11.3.2 Applying ECG Electrodes

11.3.4 Checking Paced Status

15 Monitoring Noninvasive Blood Pressure (NIBP)

11.3.5 Setting the Switch of Pacer Rejection

11.4 Changing ECG Settings

11.5 Monitoring Arrhythmia

Provides information and safety precautions for monitoring cardiac arrhythmias.

16 Monitoring Carbon Dioxide (CO2)

11.5.2 Changing Arrhythmia Settings

11.6 ST Segment Monitoring

11.7 QT/QTc Interval Monitoring

18 Review

13.1 Resp Safety Information

Covers safety warnings and precautions for respiration monitoring.

20 Discharged Patient Management

14.1 SpO2 Introduction

14.2 SpO2 Safety Information

Provides essential safety warnings and precautions for SpO2 monitoring.

22 Configuration Management

14.6 SpO2 Troubleshooting

15.1 NIBP Introduction

23 Battery

15.2 NIBP Safety Information

Covers critical safety warnings and precautions for NIBP measurements.

24 Care and Cleaning

15.5 Preparing for NIBP Measurements

16.1 CO2 Safety Information

Provides safety warnings and precautions for CO2 monitoring.

25 Maintenance

16.2 Measuring Sidestream CO2