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ZONDAN iMD 12 User Manual

ZONDAN iMD 12
132 pages
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Instructions Manual
First Edition: May 2018
I
Product Information
Product model: iMD 12
Product name: Patient Monitor
Manufacturer
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.
Registered/Production address:
Floor 14, Block D,Dianlian Technology Building,the Crossing between South Circle
Road and South Fuli Road ,Guangming District,518106 Shenzhen PEOPLE'S
REPUBLIC OF CHINA
Tel: +86 755 26865970 Fax: +86 755 26860497
Edition
First Edition: May 2018
MEDHealth supplies (Pty) Ltd
All Rights Reserved.
Distributor
MEDHealth Supplies (Pty) Ltd
Corner of Barbara and North Reef Road
Elandsfontein, Henville, 1429, Germiston, Johannesburg, Gauteng, South Africa
Reg No.: 2021/385832/07 Telephone: +27 10 013 3010
E-mail: admin@medhealthsup.com
Regulatory and Safety Specifications
Standard
The product is made under the ISO13485 quality system certified by TUV PS. The
product has passed the CE certification.
Declaration
The iMD 12 Patient Monitor is a Class IIb device and complies with the requirements of
the Council Directive 93/42/EEC concerning medical devices and carries CE-marking
accordingly.
Authorized EU Representative
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175 Fax: 0049-40-255726

Table of Contents

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ZONDAN iMD 12 Specifications

General IconGeneral
BrandZONDAN
ModeliMD 12
CategoryMonitor
LanguageEnglish

Summary

Product Information

Manufacturer and Distributor Information

Details about the product manufacturer and authorized distributor.

Regulatory and Safety Specifications

Covers standards, declarations, and EU representative information.

Chapter 1 Overview

Indications, Intended Use, and Configurations

Details on product usage, target patients, and available features.

Chapter 2 Basic Operation

Before You Begin: Unpacking, Setup, Networking

Guidance on unpacking, setting up, and connecting the monitor.

Product Description: Panels and Controls Overview

Overview of monitor components, including front and rear panels.

Side and Bottom Panel Details

Description of side panel connectors and the bottom panel layout.

Screen Display Basics and Icons

Explains the typical screen display, its elements, and menu icons.

Configuring Display Layouts

Instructions for selecting and configuring various screen display layouts.

Changing Waveform and Monitor Settings

Adjusting waveform speed, color, freezing, and general monitor settings.

Language, Date/Time, and Brightness Settings

Procedures for changing monitor language, date/time, and screen brightness.

Managing Patients and System Maintenance

Steps for patient information management and accessing system maintenance.

Chapter 3 Alarms

Alarm Types, Levels, and Visual Indicators

Details on physiological and technical alarms, their priorities, and visual cues.

Audible Alarms and Silencing Procedures

Information on audible alarm sounds, volume adjustment, and temporary silencing.

Setting and Restoring Alarm Limits

Guide to configuring individual and default alarm limits for patient safety.

Chapter 4 Monitoring ECG

Electrode Placement and Lead Set Configuration

Instructions for applying electrodes and selecting ECG lead configurations.

ECG Display and Waveform Settings

How to view ECG waveforms, adjust size, speed, color, and manage arrhythmia.

Arrhythmia Monitoring Setup and Analysis

Enabling and configuring arrhythmia analysis for ECG monitoring.

Chapter 5 Monitoring Respiration

Respiration Lead Placement and Display Settings

Guidance on electrode placement for respiration and configuring display parameters.

Apnea Alarm Configuration and Safety

Setting up apnea alarms and safety precautions for respiration monitoring.

Chapter 6 Monitoring SpO2

Sensor Application and Cable Connection

Procedures for applying SpO2 sensors and connecting cables correctly.

SpO2 Display, Pulse Rate, and Alarm Settings

Configuring the SpO2 display, pulse rate, and managing alarm limits.

Masimo SpO2 Specific Features and Setup

Details on advanced Masimo SpO2 settings like Fast Sat and Smart Tone.

Chapter 7 Monitoring NIBP

NIBP Cuff Connection and Measurement Modes

Instructions for connecting NIBP cuffs and selecting measurement modes.

NIBP Unit, Interval, and Alarm Settings

Configuring NIBP units, measurement intervals, and alarm limits.

Chapter 8 Monitoring Temperature

Probe Selection, Influencing Factors, and Display

Guide to selecting temperature probes, understanding influencing factors, and viewing data.

Temperature Unit and Alarm Settings

Configuring temperature units and setting appropriate alarm limits.

Chapter 9 Monitoring CO2

CO2 Measurement Preparation and Setup

Steps for preparing and connecting CO2 monitoring accessories and initial setup.

CO2 Settings and Safety Information

Configuration options for CO2 measurement, alarms, and safety precautions.

Chapter 10 Monitoring Invasive Blood Pressure

IBP Setup, Transducer Zeroing, and Measurement

Instructions for connecting IBP tubing, zeroing transducers, and performing measurements.

IBP Display and Alarm Settings Configuration

Adjusting IBP display settings, units, and configuring alarm limits.

Chapter 11 Monitoring Gases (Optional)

Anesthesia Gas Overview and Multi-Gas Setup

Principles of anesthesia gas monitoring and setting up the Multi-Gas module.

Gas Measurement Settings and Safety Precautions

Configuring gas measurement parameters and essential safety measures.

Chapter 12 CO Monitoring (Optional)

CO Measurement Theory and Setup Procedures

Understanding Cardiac Output measurement principles and connecting accessories.

Hemodynamics Calculation and TB Measurement

Performing hemodynamic calculations and monitoring blood temperature.

Chapter 13 Monitoring CSI (Optional)

CSI Measurement Principle and Parameters

Explanation of Cerebral State Index, its parameters, and scale.

CSI Setup and Waveform Gain Configuration

Procedures for setting up CSI monitoring and adjusting waveform gain.

Chapter 14 Review

Trend Table and Graph Display Procedures

Viewing patient data trends in tabular and graphical formats.

Waveform and Alarm Recall Functionality

Recalling historical waveforms and reviewing physiological alarm events.

Chapter 15 Drug Calculation

Calculating Drug Concentration and Infusion Rates

Tools for calculating drug concentrations, infusion rates, and titration.

Using the Titration Chart for Dosage Adjustment

Guidance on utilizing the titration chart for precise drug administration.

Chapter 16 Recording

Loading and Operating the Recorder Functions

Instructions for loading paper and starting/stopping recordings.

Selecting Record Content and Paper Handling

Choosing data for printouts and guidelines for recorder paper care.

Chapter 17 Cleaning and Care

General Cleaning Guidelines and Monitor Care

Basic principles for cleaning the monitor and its accessories to ensure longevity.

Cleaning Specific Accessories (Cables, Sensors, Cuffs, Probes)

Detailed instructions for cleaning various monitor accessories like cables and sensors.

Disinfecting and Sterilizing Procedures

Guidelines for safely disinfecting and sterilizing the monitor and its components.

Chapter 18 Maintaining the Battery

Battery Charging, Indicators, and Installation

Information on charging the battery, understanding indicators, and proper installation.

Battery Recharging, Optimization, and Disposal

Procedures for recharging, extending battery life, and safe disposal.

Chapter 19 Maintenance and Troubleshooting

Equipment Inspection and Maintenance Schedule

Regular inspection tasks and scheduled maintenance for equipment reliability.

Troubleshooting Common Equipment Problems

Guidance for diagnosing and resolving issues with ECG, SpO2, NIBP, and other modules.

A Accessories

Compatible Accessories List and Warnings

List of compatible accessories with specifications and important usage warnings.

B Specifications

ECG/ST/Arrhythmia and Respiration Specs

Technical specifications for ECG, ST, Arrhythmia, and Respiration monitoring.

SpO2, NIBP, CO2, and Gas Specifications

Detailed technical specifications for SpO2, NIBP, CO2, and Multi-Gas modules.

IBP, CSI, Power, Display, and Recorder Specs

Specifications related to IBP, CSI, power, display, recorder, and environmental parameters.

Interface and Environmental Specifications

Details on interface capabilities and operating environmental conditions.

C Alarm

Physiological Alarm Information and Causes

Information on physiological alarms, their triggers, and solutions.

Technical Alarm Information and Solutions

Details on technical alarms, their causes, and troubleshooting steps.

D Glossary

Terminology and Abbreviation Definitions

Definitions of key terms and abbreviations used throughout the manual.

E Electromagnetic Compatibility

EMC Instructions for Use and Declarations

Guidelines for using the monitor in an electromagnetic environment and EMC compliance.

Emissions, Immunity, and Separation Distances

Details on electromagnetic emissions, immunity levels, and recommended separation distances.

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