Mortara Surveyor S4 User Manual

i
REF 9515-190-50-ENG Rev C1
Surveyor S4
MOBILE MONITOR
USER MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Mortara Surveyor S4 Specifications

General

Category	Medical Equipment
Battery	Lithium Ion
Networking	Ethernet
Operating Temperature	0° to 40°C
Storage Temperature	-20° to 60°C

Summary

General Statements

Technical Support and Service

Provides contact information for Mortara headquarters, sales, and service locations worldwide.

Notices

Manufacturer's Responsibility

Outlines Mortara's responsibility for product safety and performance.

Responsibility of the Customer

Defines the user's role in device maintenance and manual upkeep.

Equipment Identification

Explains how to identify the device via serial and reference numbers.

Copyright and Trademark Notices

States document copyright and trademark ownership.

Other Important Information

General disclaimers about warranty and document updates.

Warranty Information

Your Mortara Warranty

Details the product warranty terms, duration, exclusions, and limitations.

User Safety Information

Safety Symbols and Definitions

Explains the meaning of WARNING, CAUTION, and NOTE symbols used in the manual.

Safety Regulations and General Warnings

Lists safety compliance, user qualifications, and general warnings for device operation.

General Care

S4 and Accessory Care Precautions

General care and cleaning instructions for the S4 mobile monitor and its accessories.

Inspection Prior to Clinical Use

Steps to inspect the device and accessories before clinical operation.

Cleaning and Disinfecting Procedures

Detailed procedures for cleaning and disinfecting the S4 and accessories.

Maintenance Procedures

Describes recommended maintenance procedures and servicing schedule.

Battery Life and Charge Time

Information on battery run-time and charging specifications for the device.

Product Life and Disposal

Defines the device's expected product life and provides disposal instructions.

Electromagnetic Compatibility (EMC)

EMC Overview and Guidelines

Introduces EMC, its importance, and general operational guidelines for the device.

Electromagnetic Emissions Declaration

Details emissions standards and guidance for the device's operational environment.

Electromagnetic Immunity Declaration

Outlines immunity standards and guidance for the device's operational environment.

RF Immunity Requirements

Specifies immunity requirements for conducted and radiated RF signals.

Recommended Separation Distances

Provides guidance on safe distances from RF devices to prevent interference.

USA and Canada Radio Regulations

Covers FCC and IC compliance for radio transmission and SAR testing.

Introduction

General Information

Overview of the manual's purpose and the Surveyor S4 mobile monitor.

Indications For Use

Specifies the intended use, patient populations, and warnings for the S4 device.

System Overview

Describes the S4 system components, SAM modules, and required equipment.

S4 Device Elements Overview

Details key device features like WiFi LED, LCD, Nurse Call Button, and ECG connection.

Carrying Pouches

Information on disposable pouches for wearing the S4 device.

Battery Charger Operation

Explains the operation and LED indicators of the Li-Ion battery charger.

Unpacking and Set Up

Checking Contents

Lists the components included with the S4 shipment upon delivery.

Optional S4 Accessories

Lists available accessories such as pouches and battery charger components.

Battery Installation Procedure

Step-by-step instructions for installing batteries (rechargeable or AA) into the S4.

Patient Preparation for Quality ECG

Quality ECG Data Acquisition

Explains factors for obtaining good ECG data and causes of poor quality ECG.

Skin Preparation

Details procedures for preparing patient skin for electrode placement.

Electrode Placement Guidelines

Provides instructions on applying electrodes for ECG monitoring.

Pacemaker Patient Considerations

Notes special considerations for patients with pacemakers during ECG monitoring.

Electrode Locations for 12-Lead ECG

Details electrode placement for 12-lead ECG using the LeadForm cable.

Using the LeadForm 12-Lead Cable

Explains the use and electrode placement for the 12-lead LeadForm cable.

Electrode Locations for 5-Wire Cable

Details electrode placement for the 5-wire ECG cable.

Electrode Locations for 3-Wire Cable

Details electrode placement for the 3-wire ECG cable.

Pacemaker Electrode Placement (5-Wire)

Illustrates electrode placement for pacemaker patients using a 5-wire cable.

Checking ECG Signal Quality

Guides on verifying ECG signal quality and lead connections after attachment.

Operation

Powering On and Quick Setup

Steps to power on the S4 and describes the initial quick setup guide.

Screen Time-Out and Reactivation

Explains display dimming, reactivation, and Nurse Call button functions.

Powering Off the S4

Instructions for powering down the S4 mobile monitor and suspending monitoring.

Main Screen Layout

Overview of the S4's main screen layout and its functional display areas.

Device/Patient Status Area Details

Details information displayed in the status area: lock, WiFi, battery, IDs.

Lock Icon and Passcode Access

Explains the lock icon and passcode access to configuration functions.

Status Indicators (Time, Battery, Slot, Monitoring)

Explains Time of Day, Battery Level, Slot IDs, and Monitoring Statuses.

Patient Hookup Display and Lead Quality

Visual aid for lead placement and connection quality indication on the torso display.

Patient Demographics and Waveform Review

Displays patient data and how to access/view ECG waveforms for lead quality.

Waveform Displays (Multiple Sets)

Shows how multiple sets of waveforms are presented for 12-lead ECG monitoring.

Waveform Failure Indicators

Explains how lead failures (e.g., square waves, "ALL FAIL") are displayed.

Monitoring Menus and Start Options

How to start ECG monitoring and select options like same/new patient.

Same Patient Monitoring Procedure

Procedure to resume monitoring a previous patient.

New Patient Monitoring Procedure

Procedure to start monitoring a new patient, including profile selection.

Heart Rate Display

How to display the patient's current heart rate on the S4 screen.

Printing Reports

How to print reports directly from the S4 to the Central Station.

Toolkit Functions

Accessing special functions and configuration via the toolkit icon.

Setup Screen Options (Lead and Cable Selection)

Defines lead selection for 3-wire and SAM10 configurations based on cable type.

Waveform Gain and Speed Adjustment

How to adjust waveform gain (amplitude) and speed settings.

Suspend Monitoring and Power Off

How to suspend monitoring and power off the S4 device.

Passcode Entry for Protected Functions

Screen for entering the administrative passcode for protected functions like suspend/power off.

Configuring the S4

Accessing Configuration Settings

How to access configuration settings via the toolkit and passcode entry.

Configuration Settings Screen

Main screen for configuring various device settings like Host, Network, Language.

Host Settings Configuration

Configuration for Central Station IP, Unit ID, and Bed ID.

Network Settings Configuration

Configuration of WiFi network settings, including SSID, security, and passkey.

Language Settings

Selection of the user interface language for the S4.

WiFi Diagnostics and Troubleshooting

Tools for assessing WiFi connection, network status, and troubleshooting.

Reset Passcode and Hardware Diagnostics

Procedures for changing the passcode and checking device hardware diagnostics.

S4 and SAM Version Information

Displays current software versions, build dates, serial, and part numbers.

Performing ECG Monitoring

Power-On and Patient Setup

Steps for powering on the S4 and preparing the patient with electrode placement.

Patient Cable Hookup

Instructions for connecting the patient cable to electrodes and the S4 device.

Confirm Signal Quality and Start New Monitoring

Verifying signal quality and initiating monitoring for a new patient.

Same Patient Monitoring and Confirmation

Procedure to resume monitoring a previous patient and confirm active status.

Ending a Monitoring Session

Steps to end an active monitoring session on the S4, including confirmation.

Product Specifications

General and Environmental Specifications

Details on instrument type, channels, frequency range, and environmental conditions.

Power Requirements and Battery Specifications

Information on battery types, run-time, and charging time for the device.

Display and ECG Specifications

Technical specifications related to the device's LCD display and ECG acquisition.

Wireless Network Specifications

Details on wireless protocols, security, network requirements, and performance metrics.

Troubleshooting & Error Codes

Power, Battery, Display, and ECG Trace Issues

Troubleshooting common problems with power, battery, display, and ECG signal noise.

Network Transmission and Connectivity Issues

Troubleshooting network transmission, connectivity, and Central Station communication problems.

Error Messages and Resolutions

Explains common error messages displayed by the S4 and their suggested resolutions.

Reordering Accessories & Consumables

Accessory and Part Number List

Lists Mortara part numbers for ordering spare parts and consumables for the S4.

Applicable Standards

Safety, Performance, and EMC Standards

Lists applicable IEC, EU, US, and Canadian safety, performance, and EMC standards.

Radio and R&TTE Directives

Lists applicable radio and R&TTE directives relevant to the device.

Medical Device and Software Lifecycle Standards

Lists standards for risk management, FDA compliance, and medical device software lifecycle.