Mortara Surveyor S4 User Manual
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.
i
Copyright © 2015
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
E-mail: techsupport@mortara.com
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document
may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written
consent of Mortara Instrument, Inc. V1.1.0 2015-11
Mortara is a registered trademark of Mortara Instrument, Inc. Surveyor™ is a trademark of Mortara Instrument,
Inc. All other trademarks and registered trademarks are the property of their respective owners.
Product License
This product and its accompanying software are subject to Mortara Instrument’s End User License Agreement. By
using this product and its accompanying software, you agree to the terms and conditions specified therein.
Open-Source Software
Mortara Instrument uses a variety of software and components created by the open-source community. The use of
open-source software and components is essential to creating robust, high quality products, as these have been
under constant scrutiny and review by the open-source community. Upon explicit written request, Mortara
Instrument will make available to customers the source code for open-source components used in this product
within three years after the purchase of the product. Mortara Instrument may charge a fee for delivering such
source code. Permission to use, copy, modify, and/or distribute this software for any purpose with or without fee is
hereby granted, provided that the above copyright notice and this permission notice appear in all copies.
Additional Notices
Portions of this product incorporate software and components that are copyrighted by their respective owners
including:
Linux Operating System Kernel
Licensed under the GNU General Public License version 2 (GPLv2).
Copyright (C) 1989, 1991 Free Software Foundation, Inc.
All rights reserved.
BusyBox Utilities
Licensed under the GNU General Public License version 2 (GPLv2).
See http://www.busybox.net/license.html
All rights reserved.
Linux WLAN Driver SD8787
Licensed under the GNU General Public License version 2 (GPLv2).
© Marvel® Technology Group, Ltd.
All rights reserved
wpa_supplicant
Copyright (c) 2003-2013, Jouni Malinen <j@w1.fi> and contributors.
This software may be distributed, used, and modified under the terms of BSD license.
All rights reserved.
Dropbear SSH
Copyright (c) 2002-2013 Matt Johnston
Portions copyright (c) 2004 Mihnea Stoenescu
All rights reserved.
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QT Framework
© 2013 Digia Plc and/or its subsidiary(ies) and other contributors.
License under GNU Lesser General Public License version 2.1 (LGPLv 2 .1).
SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND ANY
EXPRESS OR IMPLIED WARRANTIES, INCLUDING (BUT NOT LIMITED TO) THE IMPLIED WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE DISCLAIMED. IN NO EVENT
SHALL THE COPYRIGHT OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT,
INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED
TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR
BUSINESS INTERRUPTION), HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY; WHETHER IN
CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE); ARISING IN ANY
WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
ii
TABLE OF CONTENTS
1.
GENERAL STATEMENTS ................................................................................................................ 1
TECHNICALSUPPORTANDSERVICE.....................................................................................................................................1
2. NOTICES ........................................................................................................................................... 2
MANUFACTURER’SRESPONSIBILITY............................................................................................................................... .....2
RESPONSIBILITYOFTHECUSTOMER....................................................................................................................................2
EQUIPMENTIDENTIFICATION.............................................................................................................................................2
COPYRIGHTANDTRADEMARKNOTICES............................................................................................................................... 2
OTHERIMPORTANTINFORMATION.....................................................................................................................................2
3. WARRANTY INFORMATION ............................................................................................................ 3
YOURMORTARAWARRANTY............................................................................................................................................3
4. USER SAFETY INFORMATION ........................................................................................................ 5
SAFETYREGULATIONS......................................................................................................................................................5
WARNINGS....................................................................................................................................................................5
PowerSupplyWarnings.............................................................................................................................................6
Accessories,Cables,andExternalConnectionsWarnings..........................................................................................7
DefibrillationandElectrosurgeryWarnings...............................................................................................................7
ECGWarnings............................................................................................................................................................7
CAUTIONS.....................................................................................................................................................................8
5. EQUIPMENT SYMBOLS AND MARKINGS ................................................................................... 10
SYMBOLDELINEATION............................................................................................................................... ....................10
6. GENERAL CARE ............................................................................................................................. 11
PRECAUTIONSFORS4....................................................................................................................................................11
PRECAUTIONSFORLI‐IONBATTERYCHARGER,ACPOWERPACKANDCORD............................................................................11
INSPECTIONPRIORTOCLINICALUSE.................................................................................................................................11
CLEANINGANDDISINFECTING.........................................................................................................................................12
MAINTENANCE.............................................................................................................................................................13
BATTERYLIFEANDCHARGETIME.....................................................................................................................................15
PRODUCTLIFE..............................................................................................................................................................16
DECOMMISSIONINGANDDISPOSAL..................................................................................................................................16
7. ELECTROMAGNETIC COMPATABILITY (EMC) ........................................................................... 17
GUIDANCEANDMANUFACTURER’SDECLARATION:ELECTROMAGNETICEMISSIONS..................................................................18
GUIDANCEANDMANUFACTURER’SDECLARATION:ELECTROMAGNETICIMMUNITY...................................................................18
GUIDANCEANDMANUFACTURER’SDECLARATION:ELECTROMAGNETICIMMUNITY...................................................................19
RECOMMENDEDSEPARATIONDISTANCESBETWEENPORTABLEANDMOBILERFCOMMUNICATIONSEQUIPMENTANDTHEEQUIPMENT
............................................................................................................................... ..................................................20
USAANDCANADARADIOREGULATIONS..........................................................................................................................21
8. INTRODUCTION .............................................................................................................................. 23
GENERALINFORMATION................................................................................................................................................23
INDICATIONSFORUSE...................................................................................................................................................23
SYSTEMOVERVIEW.......................................................................................................................................................24
SAM10......................................................................................................................................................................24
SAM5........................................................................................................................................................................24
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TABLE OF CONTENTS
C
ARRYINGPOUCHES......................................................................................................................................................27
BATTERYCHARGER.......................................................................................................................................................28
9. UNPACKING AND SET UP ............................................................................................................. 29
CHECKINGCONTENTS....................................................................................................................................................29
BATTERYINSTALLATION.................................................................................................................................................30
10. PATIENT PREPARATION FOR QUALITY ECG ............................................................................ 31
QUALITYECGDATAACQUISITION...................................................................................................................................31
SKINPREPARATION.......................................................................................................................................................31
ELECTRODEPLACEMENT............................................................................................................................... ..................32
PACEMAKERPATIENTS...................................................................................................................................................32
ELECTRODELOCATIONSFOR12‐LEADECG.......................................................................................................................32
UsingtheLeadForm12‐LeadCable..........................................................................................................................33
ELECTRODELOCATIONSFOR5‐WIRECABLE.......................................................................................................................34
ELECTRODELOCATIONSFOR3‐WIRECABLE.......................................................................................................................35
PACEMAKERPATIENTS...................................................................................................................................................35
CHECKINGECGELECTRODEANDLEADWIRESIGNALQUALITY..............................................................................................36
11. OPERATION .................................................................................................................................... 37
POWERINGONTHES4..................................................................................................................................................37
SCREENTIME‐OUT&REACTIVATION............................................................................................................................... .37
ONSCREENQUICKSETUPGUIDE.....................................................................................................................................37
POWERINGOFFTHES4.................................................................................................................................................38
MAINSCREEN..............................................................................................................................................................39
Device/Patient..........................................................................................................................................................40
StatusArea...............................................................................................................................................................40
LockIcon...................................................................................................................................................................40
TimeofDay..............................................................................................................................................................41
BatteryLevelIndicator.............................................................................................................................................41
CentralStationSlotName+UnitID&BedID..........................................................................................................41
MonitoringStatus....................................................................................................................................................41
PatientHookupDisplay&LeadQualityIndicators..................................................................................................42
PatientDemographicsScreen..................................................................................................................................43
WaveformReview....................................................................................................................................................43
MONITORINGMENUS...................................................................................................................................................46
HEARTRATEDISPLAY....................................................................................................................................................49
PRINTING............................................................................................................................... .....................................50
TOOLKIT.....................................................................................................................................................................51
WaveformGain(Amplitude)....................................................................................................................................53
WaveformSpeed......................................................................................................................................................53
PowerOff–SuspendMonitoring.............................................................................................................................54
12. CONFIGURING THE S4 .................................................................................................................. 57
HOSTSETTINGS............................................................................................................................................................58
NETWORKSETTINGS......................................................................................................................................................59
LANGUAGESETTINGS....................................................................................................................................................59
WIFIDIAGNOSTICS.......................................................................................................................................................60
RESETPASSCODE............................................................................................................................... ...........................60
HARDWAREDIAGNOSTICS..............................................................................................................................................60
S4VERSION................................................................................................................................................................61
SAMVERSION.............................................................................................................................................................61
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TABLE OF CONTENTS
13.
PERFORMING ECG MONITORING ................................................................................................ 63
POWER‐ON.................................................................................................................................................................63
PATIENTPREP..............................................................................................................................................................63
PATIENTCABLEHOOKUP................................................................................................................................................63
CONFIRMGOODSIGNAL................................................................................................................................................64
NEWPATIENTMONITORING...........................................................................................................................................64
SAMEPATIENTMONITORING..........................................................................................................................................65
CONFIRMMONITORINGACTIVE......................................................................................................................................65
ENDINGAMONITORINGSESSION....................................................................................................................................66
14. PRODUCT SPECIFICATIONS ........................................................................................................ 69
GENERALSPECIFICATIONS..............................................................................................................................................69
ENVIRONMENTALCONDITIONS........................................................................................................................................69
POWERREQUIREMENTS&BATTERY.................................................................................................................................69
DISPLAYSPECIFICATIONS................................................................................................................................................70
ECGSPECIFICATIONS....................................................................................................................................................70
WIRELESSNETWORKSPECIFICATIONS............................................................................................................................... 71
15. TROUBLESHOOTING & ERROR CODES ..................................................................................... 73
POWERANDBATTERY............................................................................................................................... .....................73
DISPLAYANDTOUCHSCREEN...........................................................................................................................................73
ECGTRACE............................................................................................................................... ..................................73
NETWORKTRANSMISSION............................................................................................................................... ...............74
ERRORMESSAGES........................................................................................................................................................76
16. REORDERING ACCESSORIES & CONSUMABLES ..................................................................... 77
17. APPLICABLE STANDARDS ........................................................................................................... 79
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TABLE OF CONTENTS
vi
1. GENERAL STATEMENTS
Technical Support and Service
Headquarters
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: 414.354.1600
Tel: 800.231.7437
Fax: 414.354.4760
Internet: http://www.mortara.com
European Union
Representative
Mortara Instrument Eu rope s.r.l.
(European Headquarters)
Via Cimarosa 103/105
40033 Casalecchio di Reno (BO)
Italy
Tel: +39.051.298.7811
Fax: +39.051.613.3582
Service/Technical
Support Group
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: 414.354.1600
Service: 888.MORTARA
(888.667.8272)
Fax: 414.354.4760
E-mail: techsupport@mortara.com
Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: 414.354.1600
Fax: 414.354.4760
Hospital Customers: orders.us@mortara.com
Physician Practice: orderspc.us@mortara.com
U.S. Distribution: orderspc.us@mortara.com
Mortara Instrument Germany
Bonifaciusring 15
45309 Essen
Germany
Tel: +49.201.18 55 69 70
Fax: +49.201.18 55 69 77
Mortara Instrument Netherlands
Postbus 324
5680 AH Best
Industrieweg 160b
5683 CG Best
Netherlands
Tel: +31.499.377310
Fax: +31.499.377908
Mortara Instrument Aus tralia
PO Box 7568
Baulkham Hills NSW 2153
Unit 28, 9 Hoyle Avenue
Castle Hill NSW 2154
Australia
Tel: +61 2 8070 9303
Fax: +61 2 9899 9478
Mortara Instrument UK Ltd
Units 11 & 12, Scion House
Stirling University Innovation Park
Stirling FK9 4NF
Scotland
Tel: +44.1786.444980
Fax: +44.1786.446630
1
2. NOTICES
Manufacturer’s Responsibility
Mortara Instrument, Inc. (Mortara) is responsible for the effects on safety and performance of the Surveyor™ S4
mobile monitor, as indicated by the label, only if article 2 of 93/42/EEC directive is applied, in particular:
WARNING: System installation and assembly operations, extensions, readjustments, modifications or
repairs are carried out by personnel authorized by Mortara only.
The mobile monitor is used in accordance with the instructions for use.
The mobile monitor is correctly maintained according to the standards authorized by Mortara using original
spare parts.
The mobile monitor is used with original accessories and supplies that are in compliance with the standard
specifications described in this manual.
The electrical installation of the relevant room complies with the requirements of appropriate regulations.
Responsibility of the Customer
The user of this mobile monitor is responsible for ensuring the implementation of a satisfactory maintenance
schedule. Failure to do so may cause undue failure and possible health hazards. This manual must be kept in a safe
place to prevent its deterioration and/or alteration. The user and Mortara authorized personnel must have access to
this manual at any time. The user of this mobile monitor must periodically check the accessories, their functionality
and integrity.
Equipment Identification
Mortara equipment is identified by a serial and reference number on the back of the mobile monitor. Care should be
taken so that these numbers are not defaced.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part of this
document may be photocopied, reproduced, or translated into another language without prior written consent of
Mortara.
Other Important Information
The information in this document is subject to change without notice.
Mortara makes no warranty of any kind with regard to this material including, but not limited to, implied warranties
of merchantability and fitness for a particular purpose. Mortara assumes no responsibility for any errors or
omissions that may appear in this document. Mortara makes no commitment to update or to keep current the
information contained in this document.
2
3. WARRANTY INFORMATION
Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara
products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the
number of years specified on documentation accompanying the product, or previously agreed to by the purchaser
and Mortara, or if not otherwise noted, for a period of twelve (12) months from the date of shipment.
Consumable, disposable or single use products such are warranted to be free from defects in workmanship and
materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner.
Reusable product such as, but not limited to, BATTERIES, PATIENT CABLES, LEAD WIRES, MAGNETIC
STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and
materials for a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of
the following circumstances or conditions:
a) Freight damage;
b) Supplies, accessories and internal parts NOT approved by Mortara;
c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information
guides;
d) Accident;
e) A disaster affecting the Product/s;
f) Alterations and/or modifications to the Product/s not authorized by Mortara;
g) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT
CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY
MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara
of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the
foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all
carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically
designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It
is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A
purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable
for loss, harm, or damage due directly or indirectly to an occurrence or consequence there from relating to the
Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth
herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or
damage, or the original purchase price of the Product/s when sold.
EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A
PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE
PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE
THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS
NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT,
INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF
ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT
LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED
WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE.
3
WARRANTY INFORMATION
4
4. USER SAFETY INFORMATION
WARNING: Means there is the possibility of personal injury to you or others.
CAUTION: Means there is the possibility of damage to the mobile monitor.
NOTE:
NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures are provided
for reference only and are not intended to convey actual operating techniques. Consult the actual screen in
the host language for specific wording.
Provides information to further assist in the use of the mobile monitor.
Safety Regulations
The Surveyor S4 (henceforth referred to as either Surveyor S4 or S4) is a medical mobile monitor.
The S4 and its accessories are labeled, according to applicable standards.
The S4 with all accessories that have a physical or logical connection with it, forms part of a Medical Electrical
System.
The S4 complies with various safety and performance regulations as mentioned in this manual (Applied
Standards).
Warnings
This manual gives important information about the use and safety of this mobile monitor. Deviating from
operating procedures, misuse or misapplication of the mobile monitor, or ignoring specifications and
recommendations could result in increased risk of harm to users, patients and bystanders, or damage to the
mobile monitor.
Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient
care, and adequately trained in the use of this mobile monitor. The S4 mobile monitor captures and presents
data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be
useful in determining a diagnosis; however, the data should not be used as a sole means for determining a
patient’s diagnosis.
Before attempting to use this device for clinical applications, the operator must read and understand the contents
of the user manual and other accompanying documents. Inadequate knowledge or training could result in
increased risk of harm to users, patients and bystanders, or damage to the mobile monitor. Contact Mortara for
additional training options.
Operation of the equipment beyond its specified ranges, or beyond normal physiological conditions of human
subjects, may cause inaccurate results.
A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
Do not mount any part of the device closer than 25 cm from outlets of flammable gases, including oxygen.
For proper operation and the safety of users or patients and bystanders, equipment and accessories must be
connected only as described in this manual.
5
USER SAFETY INFORMATION
Repairs and modification must be made by authorized and trained technical personnel. Unauthorized
modifications and repairs will void the S4 warranty and may pose a danger to patients and users.
If additional devices beyond the S4 are connected to the patient, leakage currents could add up and should be
accounted for.
The S4, as all medical equipment or systems, requires special precautions regarding EMC, and should be
installed and put into service according to the EMC information provided in the installation procedure to obtain
a sufficient degree of immunity as well as not to create disturbance to other equipment. Refer to the specific
EMC instructions in this manual.
The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators, electrosurgery equipment and ultrasound machines. Do
not use the S4 system in the presence of imaging equipment such as magnetic resonance imaging (MRI) and
tomography systems. Simultaneous operation may damage the device or lead to erroneous results.
There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
Portable and mobile RF communications equipment may affect medical electrical equipment or systems as well
as the S4 and its accessories. Do not operate the S4 near sources of high frequency emissions (e.g.
microwaves). Unauthorized wireless devices, such as personal access points and WiFi hotspots including those
available on personal smartphones, may also interfere with the operation of the system.
A mobile monitor is not intended to replace clinical assessments. It is important that a qualified individual
regularly supervise the patient.
The S4 is restricted to use on one patient at a time.
Power Supply Warnings
Only use the recommended batteries. Use of alternate batteries may damage the device or cause other hazards.
Only charge Mortara Rechargeable Battery (Mortara Re-Order Number 4800-018) in the Mortara Li-Ion
Battery Charger. Attempting to charge unauthorized batteries may result in damage to the unauthorized battery
and/or the Li-Ion Battery Charger.
The S4 is a battery operated device that transmits data reflecting a patient’s physiological condition to a
receiving device. During operation failure, data transmission and LCD information will cease to occur. In the
case of battery depletion, replace the batteries on the device to resume monitoring. In mission critical
conditions, it is advisable to have a backup device available.
Only use the Mortara-provided external battery charger and adapter with the S4. Ensure that the electrical
installation also complies with local safety requirements for the environment where it is used.
Regularly check all cables for damage and proper connection. Do not use equipme
nt with a damaged cable.
The S4 contains an internal battery. The following precautions should be taken regarding the internal battery:
o Do not immerse in water.
o Do not heat or throw in fire.
o Do not leave in conditions over 60 ºC.
o Do not crush or drop.
o Only use the approved batteries.
o Follow the instructions in the disposal section of this manual when taken out of service.
6
USER SAFETY INFORMATION
The S4 rechargeable battery must be initially fully charged prior to use.
When the S4 initially powers on, the screen will illuminate if the batteries are installed properly and charged.
Remove the S4 from service and contact Mortara if the screen does not activate when new or fully charged
batteries are initially installed.
AA batteries are known to leak their contents when stored for an extended period of time in unused equipment.
Always remove the batteries after completing operating the mobile monitor. Always place rechargeable
batteries in the battery charger when not in use. This ensures that the batteries are recharged for the next time
the mobile monitor is operated.
There is a potential pinch hazard when applying the battery compartment cover to the device that could result in
minor injury. Care should be taken to avoid entrapment of fingers when performing this operation.
Accessories, Cables, and External Connections Warnings
The S4 is designed to meet applicable specifications when using Mortara-approved patient cables and
accessories. Use of non-approved cables and accessories may result in reduced performance or electromagnetic
interference, and may pose possible patient and user safety concerns.
Do not use excessive force on any of the connection cables and handle all accessories with care.
Conductive parts of the ECG patient cables, electrodes, and associated connections of type CF applied parts,
including the neutral conductor of the patient cable and electrode should not come into contact with other
conductive parts including earth ground.
To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with
mobile monitor or patient cables.
Accessories may be provided with separate user manuals. Read these manuals thoroughly and refer to them for
specific functions. It is recommended to keep all manuals together.
To avoid potential for spread of disease or infection, single-use components and accessories (e.g., electrodes,
pouches, etc.) must not be reused. To maintain safety and effectiveness, ECG electrodes and sensors must not
be used beyond their expiration date or useful life.
All accessories including cables, connectors and other patient-applied parts supplied with the S4 do NOT
contain any Latex. If the patient develops an allergic reaction or rash, immediately remove the accessory and
inform Mortara.
Defibrillation and Electrosurgery Warnings
The S4 has not been designed for use together with electrosurgery equipment.
The S4 is defibrillator protected in compliance with IEC 60601-2-25 and/or IEC 60601-2-27 standards if used
with Mortara-approved patient cables. Defibrillation while using non-approved patient cables may damage the
device beyond repair and cause a safety hazard to the patient.
ECG Warnings
Excessive patient movement could interfere with the operation of the system.
Proper clinical procedure must be employed to prep the electrode and sensor sites, and to monitor the patient for
excessive skin irritation, inflammation, or other adverse reactions. Electrodes and other sensors that are
intended for short-term use should be removed from the patient promptly following use.
7
USER SAFETY INFORMATION
12-lead ECGs acquired through the S4 with 10-wire cable will normally use a modified lead system with the
limb electrodes positioned on the torso. Although this is a generally accepted practice (e.g., in stress testing),
the different electrode positions can cause morphology changes on the ECG, thus influencing their
interpretation. Most frequently seen differences are a vertical and rightward axis shift, minor changes of
evidence of old inferior infarction and changes in the T-wave in the limb leads. It is recommended that you
place the electrodes as close as possible to the normal limb positions avoiding the possibility of causing artifact.
The right arm and left arm electrodes should be placed on the clavicles as close as possible to the arms. The left
leg electrode should be placed as close as possible to the left leg without subjecting it to the possibility of
motion artifact.
During periods of lead fail and when a reduced lead set is used for the S4, 12-lead ECG interpretation cannot be
reliably used in determining a diagnosis.
When using the 3-wire or 5-wire ECG cables, it is not possible to acquire a 12-lead ECG with the S4.
Cautions
This device must be installed as part of a system in conjunction with the Surveyor Central Station and in
accordance to guidance and minimum characteristics per requirements provided by Mortara for deployment of
the system on the hospital/clinic’s IT network. Refer to those requirements as well as Manufacturer Disclosure
Statement for Medical Device Security (MDS2) statements provided by Mortara before deploying and using the
system.
The device and patient cable should be cleaned between each use. Cleaning must be performed with the system
turned off and battery removed. Let all parts dry well before turning the power back on.
Prevent liquids from penetrating the system, components, or the monitor. Do not spray the system with liquid
cleaning agents. Do not allow the system, components or accessories to become in contact with unknown
substances which may compromise its mechanical or electrical integrity. If liquids have penetrated the system,
open by authorized personnel for inspection and let dry completely.
Do not attempt to clean the mobile monitor or patient cables by submersing into a liquid, autoclaving, or steam
cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water
and mild detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting agents,
failure to follow recommended procedures, or contact with unspecified materials could result in increased risk
of harm to users, patients and bystanders, or damage to the mobile monitor.
No user-serviceable parts inside. Screw removal by authorized service personnel only. Damaged or suspected
inoperative equipment must be immediately removed from use and must be checked/repaired by authorized
service personnel prior to continued use.
The S4 accommodates single-use or rechargeable internal batteries. If the rechargeable battery appears to
become defective, refer to Mortara Technical Support.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient cables
should be stored off of the floor away from bedrails and wheels to avoid cable damage. Roll the patient cables
into a loose loop prior to storage.
When necessary, dispose of the mobile monitor, its components and accessories (e.g., batteries, cables,
electrodes), and/or packing materials in accordance with local regulations.
Check that all operating and environment conditions such as ambient temperature meet the device’s
specifications. Allow the device to stabilize within its intended operating environment for a minimum of two
hours prior to use.
8
USER SAFETY INFORMATION
Do not exert excessive pressure on the touchscreen LCD or use a sharp or hard object with it. Excessive
pressure may permanently damage the display.
This device is not recommended for use in the presence of imaging equipment such as Magnetic Resonance
Imaging (MRI) and Computed Tomography (CT) devices, etc.
The device is UL listed:
UL-Listed device in the USA and Canada.
Upon request, Mortara can supply a service manual that includes test instructions as well as a list of spare parts
that must be used with the S4.
9
5. EQUIPMENT SYMBOLS AND MARKINGS
Symbol Delineation
Do not dispose as unsorted municipal waste.
Per European Union Directive 2002/96,
requires separate handling for waste disposal
according to national requirements
Defibrillator-proof type CF applied part
IPX4
Indicates compliance to applicable
European Union directives
Indicates the device has been
tested for safety and shall have no
harmful effect from water splashing
against the enclosure from any
direction
Caution Consult accompanying documents
Power input Consult accompanying documents
Catalog number for relevant Mortara
part
This end up Keep away from sunli ght
Serial number
Fragile, handle with care Keep dry
Storage temperature range
The illuminated LED below this icon
indicates the Power On/Off status
Speaker
(RESERVED FOR FUTURE USE)
Nurse Call/Control Button
The illuminated LED below this icon indicates
the status of the WiFi connection
Patient Cable Input
10
6. GENERAL CARE
Precautions for S4
Power off and remove the battery from the S4 before inspecting or cleaning.
Protect the S4 from water and other liquids.
Never immerse the S4 in water or other fluids.
Do not drop the S4 or subject to shock and/or vibration.
Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents that may damage
equipment surfaces.
Precautions for Li-Ion Battery Charger, AC Power Pack and Cord
Remove the AC Power Pack and AC power cord from the Li-Ion Battery Charger before inspecting or
cleaning.
Protect the AC Power Pack, AC power cord and the Li-Ion Battery Charger from water or other liquids.
Never immerse the AC Power Pack, AC power cord or the Li-Ion Battery Charger in water or other fluids.
Do not subject the AC Power Pack or the Li-Ion Battery Charger to shock and/or vibration.
Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents that may damage
equipment surfaces.
Inspection Prior to Clinical Use
Inspect your equipment prior to clinical operation. Do not use the equipment and contact an authorized service
representative for servicing if there are concerns about integrity of the system.
Verify that all cables and connectors are securely seated.
Check the case and chassis of the S4, AC Power Pack, AC power cord or the Li-Ion Battery Charger for
any visible damage.
Inspect the S4 touchscreen and controls for proper function and appearance.
Inspect the Li-Ion Battery Charger indicator LEDs for proper operation and indication of battery charging
and AC connection.
Inspect patient accessories for any visual damage.
S4 patient input connector - Verify the pins on the patient input connector are all present and are not bent or
damaged in any way. The recessed area for the patient connector should be free from debris and clean. Use
compressed air to remove any debris that has entered into the connector area.
S4 display – Verify there are no deep scratches or physical damage to the S4 mobile monitor’s display.
Inspect the display bezel to ensure it is firmly adhered to the device housing. Contact Mortara Technical
Support if the display or display bezel require replacement.
S4 battery door – Verify the S4’s battery door for proper opening and closing. Inspect the plastic door
assembly for signs of excessive wear or cracking, including the door seal to prevent fluid ingress. Replace
the battery door assembly if necessary.
S4 Battery Compartment – Inspect the S4’s battery spring contacts and the battery door latching
mechanism for signs of excessive wear. If the battery compartment has been damaged, contact Mortara
Technical Support for assistance.
11
GENERAL CARE
Battery Charger bays – Inspect the Li-Ion Battery Charger’s spring contacts and latching mechanisms for
signs of excessive wear. If a battery bay is damaged, contact Mortara for replacement.
Rechargeable Li-Ion Battery – Follow the instructions and note the cautions labeled on the rechargeable
battery. Contact Mortara for replacement.
AC Power Pack – Inspect the Li-Ion Battery Charger connector on the power pack to ensure adequate
contact to the Li-Ion Battery Charger. Inspect the AC Power Cord connector on the power pack to ensure
adequate contact to the AC Power Cord.
AC Power Cord – With the cord unplugged from AC power, visually and mechanically inspect the AC
Power Cord connectors and along its cable length for cracks in the insulating jacket or other abnormalities
that would inhibit its function. Contact Mortara for replacement.
Device Labeling – Inspect the device labeling for signs of wear and legibility. If the labeling is no longer
clear and legible, contact Mortara Technical Support for assistance.
Cleaning and Disinfecting
The following section provides information on proper cleaning directions for the S4, patient accessories, Li-Ion
battery Charger, AC Power Pack and AC Power Cord. Patient accessories should be cleaned before they are applied
to a new patient. The mobile monitor should be cleaned as per facility standard of care. The Li-Ion battery Charger,
AC Power pack and AC Power Cord should be cleaned in accordance with facility standards pertaining to power
components.
Clean the exterior surface of the device and patient cables with a mild soap and water solution. After cleaning
thoroughly dry off the device with a clean, lint-free, soft cloth.
Disinfect the device after cleaning the exterior surface as required. To disinfect the device wipe the exterior surface
with a damp, soft, lint-free cloth using a solution of 10% household bleach and water (Sodium Hypochlorite solution
consisting of a minimum 1:500 dilution and maximum of 1:10 dilution). Dry off the device with a clean, lint-free,
soft cloth.
Warnings:
Remove the batteries from the device before inspecting or cleaning.
Do not immerse the device in water or other fluids.
Do not drop the device or subject it to shock and/or vibration.
Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage
equipment surfaces.
Be careful not to use an excessive amount of disinfecting solution that could lead to fluid entering the
device. Fluid ingress may cause irreparable damage to the internal circuitry.
12
GENERAL CARE
Cautions:
Always disconnect the S4 from power source before cleaning.
Do not use harsh chemicals for cleaning. Do not use disinfectants that contain phenol as they can spot
plastics. Do not steam autoclave, gas sterilize, irradiate, subject to intense vacuum, or immerse in
water or cleaning solution. Be careful to avoid getting cleaning liquids into connectors or the mobile
monitor. If this occurs, allow the mobile monitor to dry in warm air for 2 hours, then check to make
sure all monitoring functions are working properly.
Keep the patient accessories off of the floor. Accessories that fall on the floor should be inspected for
defects, contamination, proper functionality, and cleaned or discarded according to the approved
recommendations.
The user has the responsibility to validate any deviations from the recommended method of cleaning
and disinfection.
Maintenance
The following table shows the recommended maintenance procedures for the S4, patient accessories, Li-Ion Battery
Charger, AC Power Pack and AC Power Cord. The S4 should be serviced once a year by a Mortara authorized
service technician; however, it is good practice to periodically ensure the mobile monitor is in proper working order.
This can be performed by a clinician or biomed at the hospital or healthcare delivery organization familiar with the
S4 mobile monitor, ECG signal acquisition, as well as general maintenance/calibration of biomedical equipment.
To accomplish these steps in their entirety and verify the correct operation of the system, appropriate patient
simulators or other equipment may be required.
Functionality Procedure
Mechanical Integrity Check for cracks, abrasive edges and other signs of damage.
ECG
Li-Ion Battery Charger,
AC Power Pack, AC
Power Cord
Connect ECG leads to Patient Simulator.
Start a new monitoring session.
Verify that waveforms for all leads are properly shown on the LCD.
Check for cracks, abrasive edges and other signs of damage.
Check that all connectors and AC cord length is unbroken and smooth along its
length.
Refer to the service manual for further details.
13
Functionality Procedure
Touchscreen Display
Li-Ion Battery Charger,
AC Power Pack, AC
Power Cord
ECG Cables
AC Power Cord, AC
Power Pack Captive
Cable
Approved Cleaning Agents
Clean the touchscreen with a soft cloth moistened with either a solution of
70% isopropyl alcohol in distilled water or soapy water.
Do not spray cleaner directly onto the touchscreen. Spray the cleaner onto a lint-free
cloth and then wipe the S4 mobile monitor.
To clean the touchscreen display,
1. Ensure that the touchscreen display is off. If on, press the Nurse Call button
once to turn off the display.
2. Clean the display.
Verify proper LED indicators during battery charging.
Approved Cleaning Agents
Enzymatic detergent such as ENZOL (US) or CIDEZYME (outside the US).
Distilled water.
Disinfectant solution (such as CIDEX OPA, or a 10% solution of household
bleach (5.25% sodium hypochlorite) in distilled water).
Soft, lint-free cloths and/or soft-bristled brushes.
Protective gloves and eyewear.
Procedure
1. Disconnect the mobile monito r from its power source.
2. Put on gloves and protective eyewear.
3. Prepare the detergent according to the manufacturer's instructions, and also
4. Apply detergent to product using a soft, lint-free cloth. If material is dried on,
5. Wipe smooth surfaces with the cloth.
6. Use a soft-bristle brush on visibly soiled areas and irregular surfaces.
7. Remove detergent from product using cloth dampened in distilled water.
8. Repeat as necessary.
9. Apply disinfectant solution on affected area using a soft cloth. Allow product to
10. Wipe excess solution and clean product again with cloth dampened in distilled
11. Allow 2 hours for drying.
Approved Cleaning Agents
the disinfectant solution, in separate containers.
allow to sit for 1 minute. Do not immerse cable ends or lead wires in liquid as
it can cause corrosion.
sit for 5 minutes.
water.
Enzymatic detergent such as ENZOL (US) or CIDEZYME (outside the US).
Distilled water.
Disinfectant solution (such as CIDEX OPA, or a 10% solution of household
bleach (5.25% sodium hypochlorite) in distilled water).
Soft, lint-free cloths and/or soft-bristled brushes.
Protective gloves and eyewear.
GENERAL CARE
14
p
Functionality Procedure
Procedure
1. Disconnect the cables from other devices and AC power source.
2. Put on gloves and protective eyewear.
3. Prepare the detergent according to the manufacturer's instructions, and also
4. Apply detergent to product using a soft, lint-free cloth. If material is dried on,
5. Wipe smooth surfaces with the cloth.
6. Use a soft-bristle brush on visibly soiled areas and irregular surfaces.
7. Remove detergent from product using cloth dampened in distilled water.
8. Repeat as necessary.
9. Apply disinfectant solution on affected area using a soft cloth. Allow product
10. Wipe excess solution and clean product again with cloth dampened in distilled
WARNING: Servicing of this device should only be performed by Mortara authorized service personnel.
WARNING: The S4 mobile monitor and/or its accessories and parts should not be used beyond their
roduct life.
GENERAL CARE
the disinfectant solution, in separate containers.
allow to sit for 1 minute. Do not immerse cable ends or lead wires in liquid as
it can cause corrosion.
to sit for 5 minutes.
water. Allow 2 hours for drying.
Battery Life and Charge Time
Battery Life
1. With a new, fully charged rechargeable battery pack installed and under normal operating conditions, the
device should operate for a minimum of 24 hours.
2. When a fresh set (3) of single-use alkaline batteries are installed and under normal operating conditions, the
device should operate for a minimum of 12 hours.
CAUTION: The battery should be removed from the mobile monitor upon completing each clinical use.
The battery should be replaced if it is no longer holding a charge.
WARNING: Use only APPROVED BATTERIES as listed in the Accessories section. Use of unapproved
batteries may cause a hazard and will void the warranty.
CAUTION: Batteries should only be replaced by a trained user.
NOTE: Excessive wireless network traffic and network dropouts may affect the battery life.
15
GENERAL CARE
Product Life
The S4 has a defined product life of 5 years excluding accessories, cables and batteries. As required, product
service, accessories and spare parts are available through Mortara or its authorized partners. Using the mobile
monitor or its accessories and components beyond their defined life may lead to damage to the equipment or a safety
hazard to the user.
Decommissioning and Disposal
Dispose of the mobile monitor, its components and accessories (e.g., batteries, cables, electrodes), and/or packing
materials in accordance with local regulations. Do NOT incinerate the battery.
16
7. ELECTROMAGNETIC COMPATABILITY (EMC)
When using the mobile monitor, assess the electromagnetic environment affected by surrounding devices.
An electronic device may either generate or receive electromagnetic interference. Testing for electromagnetic
compatibility (EMC) has been performed on the mobile monitor according to the applicable international standards.
The mobile monitor should not be used adjacent to or stacked with other equipment. If the mobile monitor is used
in this manner, verify the mobile monitor operates in an acceptable manner in the configuration in which it will be
used.
Fixed, portable, and mobile radio frequency communications equipment may affect the performance of medical
equipment. See the appropriate EMC table for recommended separation distances between the radio equipment and
the mobile monitor.
The use of accessories, transducers, and cables other than those specified by Mortara may result in increased
emissions or decreased immunity of the equipment.
17
ELECTROMAGNETIC COMPATABILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment: Guidance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Group 2 The S4 must emit electromagnetic energy in order to perform its
intended function. Nearby electronic equipment may be affected
Class A The S4 is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
Not Applicable
Not Applicable
purposes.
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level
Electrostatic
discharge (ESD)
EN 61000-4-2
Electrical fast
transient/burst
EN 61000-4-4
Surge
IEC 61000-4-5
Voltage
fluctuations and
Interruptions
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
+/- 6 kV contact
+/- 8 kV air
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
+/- 1 kV differential
mode
+/- 2 kV common mode
<5% UT for 0.5 cycles
40% UT for 5 cycles
70% UT for 25 cycles
<5% UT for 5s
3 A/m 3 A/m Power frequency magnetic fields should
+/- 6 kV contact
+/- 8 kV air
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
+/- 1 kV differential
mode
+/- 2 kV common
mode
<5% UT for 0.5 cycles
40% UT for 5 cycles
70% UT for 25 cycles
<5% UT for 5s
NOTE: UT is the AC Mains voltage prior to application of the test level.
Electromagnetic Environment:
Guidance
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Note that monitoring is interrupted at the
level “< 5% UT for 5s”, but equipment
remains safe (as specified in
EN 60601-1-2).
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
18
ELECTROMAGNETIC COMPATABILITY (EMC)
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Immunity Test
Conducted RF
EN 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 Test
Level
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Compliance
Level
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Electromagnetic Environment: Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.2
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya, should
be less than the compliance level in each frequency
rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the equipment is used
exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
equipment.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
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