Mortara Surveyor User manual

REF 9515-169-90-ENG Rev F
Surveyor
Central System
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.

Copyright © 2019
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
For patent information, please visit www.welchallyn.com/patents
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. Mortara is a registered trademark of Mortara Instrument, Inc. E-Scribe,
HScribe, Surveyor, and VERITAS are trademarks of Mortara Instrument, Inc. Microsoft and Windows are
registered trademarks of Microsoft Corporation. V5.1, 2017-07

i
TECHNICAL SUPPORT AND SERVICE
Headquarters
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Tel: [phone]
Fax: [phone]
Internet: http://www. welchallyn.com
European Union
Representative
Mortara Instrument Europe, s.r.l.
Via Cimarosa, 103/105
40033 Casalecchio di Reno (Bologna)
Italy
Tel: [phone]
Fax: [phone]
Service/Technical
Support Group
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Service: 888.MORTARA
(888.667.8272)
Fax: [phone]
E-mail: mor_tech.suppor[email protected]
24-hour Technical Support
Same-day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts
Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224 U.S.A.
Tel: [phone]
Fax: [phone]
Mortara Instrument Germany
Hofgartenstraße 16
72379 Hechingen
Germany
Tel.: [phone]
Fax: [phone]
Mortara Instrument Netherlands
“Amerika” Gebouw– 7e verdieping
Hoogoorddreef 15
1101 BA Amsterdam
Netherlands
Tel.: [phone]
Mortara Instrument Australia
Head Office
Suite 4.01, 2-4 Lyonpark Road
Macquarie Park, Sydney
NSW 2113 Australia
Tel: [phone]
Fax: [phone]
Mortara Instrument UK
Clinitron House, Excelsior Road
Ashby de la Zouch
Leicester LE65 1JG
Tel: [phone]
Fax: [phone]

ii
NOTICES
Manufacturer’s Responsibility
Mortara Instrument, Inc. is responsible for the effects on safety and performance of the device, as indicated by the
label, only if article 2 of 93/42/EEC directive is applied, inparticular:
 System installation and assembly operations, extensions, readjustments, modifications or repairs are carried
out by personnel authorized by Mortara Instrument, Inc.only.
 The device is used in accordance with the instructions foruse.
 The device is correctly maintained according to the standards authorized by Mortara Instrument, Inc. using
original spare parts.
 The device is used with compatible accessories and supplies. Contact Mortara or one of its affiliates for a
current list of compatible accessories andsupplies.
 The electrical installation of the relevant room complies with the requirements of appropriate regulations.
Responsibility of the Customer
The user of this device 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 Instrument, Inc. authorized personnel must have
access to this manual at any time.
The user of this device must periodically check the transmitters and monitors, their functionality and the integrity of
their accessories.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by serial and part numbers on the side, back, or bottom of the
device. 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 Instrument, Inc.
Other Important Information
The information in this document is subject to change without notice.
Mortara Instrument, Inc. 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 Instrument, Inc. assumes no
responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no
commitment to update or to keep current the information contained in this document.

iii
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 as, but not limited to, PAPER or ELECTRODES 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, BLOOD PRESSURE CUFFS, BLOOD PRESSURE
HOSES, TRANSDUCER CABLES, Y-CABLES, 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) Parts and/or accessories of the Product/s not obtained from or approved by Mortara;
c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheetsand/or
information guides;
d) Accident; a disaster affecting theProduct/s;
e) Alterations and/or modifications to the Product/s not authorized byMortara;
f) 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 therefrom 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.

iv
TABLE OF CONTENTS
TECHNICAL SUPPORT AND SERVICE ..............................................................................................................................I
NOTICES ......................................................................................................................................................................II
MANUFACTURER’S RESPONSIBILITY .........................................................................................................................................II
RESPONSIBILITY OF THE CUSTOMER .........................................................................................................................................II
EQUIPMENT IDENTIFICATION..................................................................................................................................................II
COPYRIGHT AND TRADEMARK NOTICES....................................................................................................................................II
OTHER IMPORTANT INFORMATION..........................................................................................................................................II
WARRANTY INFORMATION ........................................................................................................................................III
YOUR MORTARA WARRANTY................................................................................................................................................ III
1. SAFETY INFORMATION .......................................................................................................................................1
SAFETY REGULATIONS.......................................................................................................................................................... 1
WARNINGS........................................................................................................................................................................ 1
The following warnings concern telemetry monitoring: ........................................................................................... 5
The following warnings concern pulse oximetry (SpO2) telemetry monitoring:....................................................... 5
The following warnings concern heart rate for telemetry monitoring: .................................................................... 6
The following warnings concern pacemaker patients for telemetry monitoring:..................................................... 7
NOTES.............................................................................................................................................................................. 8
2. EQUIPMENT SYMBOLS AND MARKINGS .............................................................................................................9
PRODUCT LIFETIME ............................................................................................................................................................. 9
3. ELECTROMAGNETIC COMPATIBILITY..................................................................................................................11
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions ............................................................... 12
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity ................................................................ 12
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity ................................................................ 13
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the
System..................................................................................................................................................................... 14
4. INTRODUCTION ................................................................................................................................................15
AUDIENCE ....................................................................................................................................................................... 15
INTENDED USE ................................................................................................................................................................. 15
INDICATIONS FOR USE ....................................................................................................................................................... 15
SYSTEM DESCRIPTION........................................................................................................................................................ 16
Surveyor Central with WiFi telemetry ..................................................................................................................... 17
Surveyor Central with Multiple Control of Same Channels ..................................................................................... 17
Surveyor Central USB-WATCHDOG ......................................................................................................................... 17
OPTIONAL SYSTEM COMPONENTS........................................................................................................................................ 18
Surveyor Central with Wireless Access Points......................................................................................................... 20
SURVEYOR CENTRAL NETWORK ........................................................................................................................................... 20
SURVEYOR CENTRAL CONNECTIONS...................................................................................................................................... 22
Peripheral Workstation Component Interconnect .................................................................................................. 22
INSTALLATION AND CONNECTIONS ....................................................................................................................................... 23
ROUTINE MAINTENANCE AND CLEANING INSTRUCTIONS .......................................................................................................... 23
DISPOSAL OF WASTE MATERIALS......................................................................................................................................... 23
PRIVACY INFORMATION ..................................................................................................................................................... 24

v
TABLE OF CONTENTS
5. USING THE SYSTEM...........................................................................................................................................25
TURNING ON THE SURVEYOR CENTRAL WORKSTATION............................................................................................................. 25
Display Screen ......................................................................................................................................................... 25
MULTI-PATIENT DISPLAY BUTTONS ...................................................................................................................................... 26
MULTI-PATIENT DISPLAY SUB-SCREEN FIELDS.......................................................................................................................... 27
SpO2 display............................................................................................................................................................ 27
SINGLE-PATIENT DISPLAY ................................................................................................................................................... 29
Selected telemetry patient sub-screen, Telemetry Traces view .............................................................................. 29
S12/S19 patient traces view.................................................................................................................................... 30
Single-patient display tabs...................................................................................................................................... 30
EVENT/ALARM AND FULL-DISCLOSURE REVIEW ...................................................................................................................... 31
BEGINNING A 12-LEAD ECG MONITORING SESSION................................................................................................................. 32
To begin a 12-lead monitoring session: .................................................................................................................. 33
ID Format ................................................................................................................................................................ 34
Reduced Lead-set Monitoring: Ambulatory Transmitter ........................................................................................ 35
5-wire Monitoring ................................................................................................................................................... 35
3-wire Monitoring ................................................................................................................................................... 36
Using a Protocol...................................................................................................................................................... 37
ENDING A MONITORING SESSION:TELEMETRY ....................................................................................................................... 38
RESTARTING A MONITORING SESSION:TELEMETRY ................................................................................................................. 38
Discharge: Surveyor S12/S19 Patient Monitor........................................................................................................ 38
Standby: Surveyor S12/S19 Patient Monitor........................................................................................................... 38
Resume Monitoring: Surveyor S12/S19 Patient Monitor ........................................................................................ 38
6. SETTINGS..........................................................................................................................................................39
DISPLAY SETTINGS............................................................................................................................................................. 40
Multi-patient........................................................................................................................................................... 40
Traces...................................................................................................................................................................... 40
Parameters.............................................................................................................................................................. 40
ID............................................................................................................................................................................. 41
ECG Filter................................................................................................................................................................. 41
ECG Gain (mm/mV)................................................................................................................................................. 41
Plethysmogram Gain .............................................................................................................................................. 41
Invasive Pressure Waveform Gain .......................................................................................................................... 41
Capnography Waveform Gain ................................................................................................................................ 41
PRINT SETTINGS................................................................................................................................................................ 41
Rhythm.................................................................................................................................................................... 41
12-leads................................................................................................................................................................... 42
ST Report................................................................................................................................................................. 42
Trend....................................................................................................................................................................... 42
Summary report ...................................................................................................................................................... 42
SIGNAL SETTINGS .............................................................................................................................................................. 45
Analyze Pacers ........................................................................................................................................................ 45
ECG.......................................................................................................................................................................... 45
Protocol................................................................................................................................................................... 46
SAVE AS PROFILE........................................................................................................................................................... 46
7. ALARM SETTINGS .............................................................................................................................................47
PATIENT MONITOR-SPECIFIC ALARM INTERACTIONS................................................................................................................ 47
ALARMS AND EVENTS ........................................................................................................................................................ 48
Alarm Hierarchy ...................................................................................................................................................... 48
Alarm Display.......................................................................................................................................................... 48
How to Silence Alarms ............................................................................................................................................ 48
PERMANENT AND NON-PERMANENT ALARMS ........................................................................................................................ 49

TABLE OF CONTENTS
vi
OVERLAPPING ALARMS...................................................................................................................................................... 49
ALARM AND EVENT MESSAGES ........................................................................................................................................... 49
SUSPENDED ALARMS......................................................................................................................................................... 49
ALARM RE-ACTIVATION ..................................................................................................................................................... 50
DISABLING ALARMS .......................................................................................................................................................... 50
SETTING ALARM EVENT AUTOMATICPRINTOUTS .................................................................................................................... 51
CHANGING ALARM LIMITS.................................................................................................................................................. 51
CHANGING ALARM PRIORITY .............................................................................................................................................. 51
ELECTROCARDIOGRAM ALARMS:HEART RATE ....................................................................................................................... 52
ELECTROCARDIOGRAM ALARMS:HEART RATE FOR S12/S19 PATIENT MONITORING.................................................................... 52
ELECTROCARDIOGRAM ALARMS:CARDIAC ARREST ................................................................................................................. 52
VENTRICULAR TACHYCARDIA ALARM .................................................................................................................................... 52
ST ALARMS ..................................................................................................................................................................... 53
EXTENDED ARRHYTHMIA ALARMS........................................................................................................................................ 53
RESTING ECG .................................................................................................................................................................. 53
SPO2ALARMS................................................................................................................................................................. 54
TECHNICAL ALARMS .......................................................................................................................................................... 54
PROTOCOL EVENTS ........................................................................................................................................................... 54
8. AVERAGES ........................................................................................................................................................55
ST VALUES ...................................................................................................................................................................... 56
OTHER DISPLAYED INFORMATION ........................................................................................................................................ 56
9. TRENDS ............................................................................................................................................................57
TREND SELECT.................................................................................................................................................................. 57
DUAL TRENDS .................................................................................................................................................................. 57
Upper Trend ............................................................................................................................................................ 57
Lower Trend ............................................................................................................................................................ 57
Minimum/Average/Maximum ................................................................................................................................ 57
ALL ST TRENDS ................................................................................................................................................................ 59
Minimum/Average/Maximum ................................................................................................................................ 59
10. TRACES.............................................................................................................................................................61
PROTOCOL TIMERS ........................................................................................................................................................... 62
ACCESS POINT.................................................................................................................................................................. 62
ST VALUES ...................................................................................................................................................................... 62
QT/C VALUES .................................................................................................................................................................. 63
ARRHYTHMIA VALUES........................................................................................................................................................ 63
SPO2VALUES.................................................................................................................................................................. 63
S12/S19 NUMERIC PARAMETER VALUES ............................................................................................................................. 63
LEARN ............................................................................................................................................................................ 63
ECG GAINS ..................................................................................................................................................................... 64
WAVEFORM GAINS ........................................................................................................................................................... 65
SHOW 10 MM/S.............................................................................................................................................................. 65
11. REVIEW ............................................................................................................................................................67
MULTI-PATIENT REVIEW .................................................................................................................................................... 67
SINGLE-PATIENT REVIEW.................................................................................................................................................... 68
EVENT REVIEW ................................................................................................................................................................. 68
TREND REVIEW ................................................................................................................................................................ 69
NAVIGATION TO DAY AND TIME .......................................................................................................................................... 69
SELECT TREND FOR WAVEFORM TRACES DISPLAY ................................................................................................................... 69
GAIN.............................................................................................................................................................................. 70
MULTI (TRACES), 12-LEAD AND CUSTOM DISPLAY.................................................................................................................. 70

vii
TABLE OF CONTENTS
GRAPHICAL TRENDS REVIEW............................................................................................................................................... 71
TABULAR TRENDS REVIEW.................................................................................................................................................. 73
PRINT............................................................................................................................................................................. 74
SETTINGS ........................................................................................................................................................................ 74
RELOAD .......................................................................................................................................................................... 75
ALARM EVENTS LIST.......................................................................................................................................................... 75
Multi-patient Alarm Events List .............................................................................................................................. 75
Single-patient Alarm Events List ............................................................................................................................. 75
ALARM EVENTS FILTERING.................................................................................................................................................. 75
12. PATIENTS..........................................................................................................................................................77
NEW .............................................................................................................................................................................. 77
MODIFY.......................................................................................................................................................................... 77
DELETE ........................................................................................................................................................................... 77
ARCHIVE ......................................................................................................................................................................... 78
SESSION MANAGEMENT .................................................................................................................................................... 78
Moving a Patient..................................................................................................................................................... 78
Multiple Sessions..................................................................................................................................................... 78
Blind Monitoring Sessions ....................................................................................................................................... 78
Review..................................................................................................................................................................... 79
13. SYSTEM CONFIGURATION ................................................................................................................................81
BEDS.............................................................................................................................................................................. 81
Beds menu at a Surveyor Central Repeater Station ................................................................................................ 82
PRINTERS ........................................................................................................................................................................ 82
VOLUMES........................................................................................................................................................................ 82
ALARMS.......................................................................................................................................................................... 83
Permanent (Latched) and Non-permanent (Non-latched) Alarms.......................................................................... 83
DISPLAY.......................................................................................................................................................................... 83
Display menu at a Surveyor Central Repeater Station ............................................................................................ 83
SIGNAL PROCESSING ......................................................................................................................................................... 84
PASSWORDS .................................................................................................................................................................... 84
MANAGEMENT ................................................................................................................................................................ 84
IMPORT/EXPORT .............................................................................................................................................................. 84
USER SETUP .................................................................................................................................................................... 85
Review Users ........................................................................................................................................................... 85
User-Authorized ID Formats.................................................................................................................................... 85
User Permissions for the ID Format ........................................................................................................................ 85
SHUTDOWN OR REBOOT NODE ........................................................................................................................................... 85
14. TROUBLESHOOTING FOR THECLINICIAN...........................................................................................................87
15. VERITAS ADVANCED ECG ALGORITHMS ...........................................................................................................91
HOW TO OPTIMIZE PERFORMANCE ...................................................................................................................................... 91
1. Optimize signal quality. ................................................................................................................................. 91
2. Select the right detection leads. .................................................................................................................... 91
3. Adjust the alarm thresholds to patient conditions. ....................................................................................... 92
16. ALARM DETAILS................................................................................................................................................93
17. TELEMETRY MONITORING PRINTOUTEXAMPLES..............................................................................................97
END OF SHIFT REPORT ..................................................................................................................................................... 111
18. TECHNICALSPECIFICATIONS............................................................................................................................117
System................................................................................................................................................................... 117

TABLE OF CONTENTS
viii
SPECIFICATIONS.............................................................................................................................................................. 118
System................................................................................................................................................................... 118
Alarms................................................................................................................................................................... 119
Network ................................................................................................................................................................ 122

1
1. 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 device.
Note:
Provides information to further assist in the use of the device.
Safety Regulations
Surveyor Central and Surveyor Central Repeater are medical devices labelled, according to Europeandirective
93/42/EEC (MDD), as a class IIb and class I medical devices respectively. Telemetry transmitters are produced by
Mortara Instrument, and marked per the MDD directive. Various other accessories, like the monitor and
printer are marked by the respective manufacturers according to the applicable European directives. See
respective declarations of conformity fordetails.
Surveyor Central cannot be classified as Medical Electrical Equipment according to the definition of safety standard
IEC 60601-1. The Surveyor Central, together with all accessories that have a physical or logical connection with it,
forms part of a Medical Electrical System. The Surveyor Central complies with various safety and performance
regulations as mentioned in Appendix E.
Warnings
 This manual gives important information about the use and safety of this system. Deviating from operating
procedures, misuse or misapplication of the system, or ignoring specifications and recommendations could
result in increased risk of harm to users, patients and bystanders, ordamage to the system.
 Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient
care, and adequately trained in the use of this system. Before attempting to use this system 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 system. Contact Mortara service for additional training options.
 The Surveyor Central is not designed to be used in the environment where the patient is undergoing a medical
procedure as defined in IEC 60601-1 (1.5 m from the patient). The use of an isolation transformer between
mains and Surveyor Central is required but is not a sufficient safety measure for use in the patient environment
because of data connections (data network) that might cause excessive leakage currents in some conditions.
Additional separation devices may be required. Any equipment that has a physical connection between
Surveyor Central and that is in the patient environment must have additional protection against electrical shock
(e.g., a separation device between the equipment and Surveyor Central) in order to be incompliance with
IEC 60601-1 or equivalent safety standards.
 The Surveyor Central is not battery operated. For uninterrupted use, an appropriate uninterruptible power
supply (UPS) is required. The WiFi network (telemetry) as well as any active network components such as
switch and firewall should also have the capability to remain operational in cases of general power outages. The
Surveyor Central is designed to continue operation with the last stored settings after a power interruption,
however, loss of stored data is possible if power is interrupted to the system that stores the data. When using a
backup power source such as a UPS, periodically check it to ensure it is properly functioning per the
manufacturer’s recommendations andspecifications.

2
SAFETY INFORMATION
 In order to be safely used, all accessories (such as monitors, printers, data network, etc.) must be compatible,
and comply with all safety and EMC regulations that apply to them according to their intended use; for use in
Europe, these accessories should be CE marked.
 The various parts of a Surveyor Central monitoring system (Telemetry receiver computers, control and display
computers, storage computers, printers, or bedside monitors) are all connected through a specific Ethernet data
network. This network must be installed according to all applicable standards and may only be logically or
physically connected to the outside world through a specific routing device available from Mortara Instrument.
Any other data path can lead to serious security risks and interruptions of monitoring. Other devices must not
be connected to the Surveyor data network.
 Connection of the Surveyor Network along with its associated transmitters and monitors to the IT Network in a
healthcare delivery organization may carry risks to patients, operators as well as 3rd parties. Such risks must be
carefully assessed and mitigated. The IEC 80001-1:2010 standard provides guidance to the healthcare delivery
organization for carrying out such risk assessment and mitigation. Changes to the IT Network can also
introduce new risks which should be carefully assessed andplanned.
 The Surveyor Central, as all medical equipment or systems, needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in the installation
procedure in order to obtain a sufficient degree of immunity as well as not to create disturbance to other
equipment. Refer to the specific EMC instructions in thismanual.
 In the case of a Surveyor Central system with additional control stations for display and control of the same
patient channels in multiple locations, silencing or suspending of alarms will cause the alarm to be silenced or
suspended at all the locations. Be certain that alarms are silenced or suspended by the clinician having direct
responsibility for care of the givenpatient.
 Cleaning must be performed with the system turned off. Let all parts dry well before turning the power
back on.
 Install all computer equipment with adequate space around ventilation vents. Clean and remove accumulated
dust on ventilation openings, and also remove dust regularly from the inside of the system. The last operation
must be performed byadequately trained and authorized personnel, and with the system turned off.
 Install the computer that generates the alarm sounds in such a way that the sound can be heard adequately in the
appropriate areas. The speaker is installed on the front panel of thecomputer.
 The Surveyor Central provides an alarm volume adjustment. Be sure to set the volume at a level that alarms can
be heard above the ambient noise level in the environment of use. Setting alarm volumes too low can impede
recognition of alarmsignals.
 The hardware watchdog device is connected to the computer with a USB cable and has its own power supply.
Mount it in such a way that the sound can be heard adequately in the appropriate areas. Test regularly by
temporarily removing the USB plug while the central station power is turnedon.
 The Surveyor Central must be connected to a properly grounded power terminal, and the electrical installation
must comply with the local safety requirements for the environment where it is used.
 The Surveyor Central requires more than one mains outlet. Fix multi-socket outlets properly, do not leave
them on the floor, and organize the cabling in such a way that normal work is not hampered and safety is
not compromised.
 Regularly check all mains power cables for damage and proper connection. Do not use equipment with a
damaged power cord.

3
SAFETY INFORMATION
 The Surveyor Central components are not waterproof. Avoid spillage of liquids from penetrating the system or
submersion of components and transmitters into a liquid. In case of accidental spillage, turn device off and let
dry thoroughly.
 The various manufacturers of accessories provide separate user manuals (e.g., monitor, laser printer,
Surveyor S12/S19, Surveyor S4, patient cables, electrodes). Read these manuals well and refer to them for
specific functions. It is recommended to keep all manuals together. Refer to these manuals for a list of
approved accessories. When in doubt, contact MortaraInstrument.
 Every hardware or software modification has to be made by Mortara authorized and trained technicalpersonnel.
 Do not disassemble the equipment as hazardous voltages may be present within. Contact Mortara or an
affiliated service representative for repairs.
 Technical and service documents are available uponrequest.
 Always turn the system off before connecting or disconnecting any cables.
 Do not use the system in places that are susceptible to explosion hazard or in the presence of flammable gases.
 Do not use the system in the presence of Magnetic Resonance Imaging (MRI) equipment and
tomography equipment.
 Do not insert a bootable CD/DVD on the Surveyor Central computers. Do not run any program from CD/DVD
or USB memory sticks. These I/O devices should only be used for export and import of patient ID formats,
profiles and protocols.
 Surveyor Central computers contain a small lithium battery for maintaining clock and BIOS settings which
should normally last the lifetime of the system. If the battery needs to be replaced, be sure that it is done by
qualified personnel and with a battery of the sametype.
 Surveyor Central software has been extensively tested and clinically validated. Several protection mechanisms
against software errors have been built into the Surveyor Central; however, in the unlikely event of a failure of
the software or the computer processor, the electronic (hardware) “watchdog” of the Surveyor Central sounds a
continuous loud beep and the Central station has to be power-cycled to remove this. Please inform Mortara
service personnel for further troubleshooting should this continuous loud beeping occur.
 Surveyor Central hardware has been carefully selected for reliability; however, in mission critical situations, it
might be advisable to have a backup system available at short notice. This also includes accessories such as
patient transmitters and monitors which, by nature and way of use, can be more prone to failure.
 Installation and connection to data networks must be performed by properly trained personnel, authorized by
Mortara Instrument, Inc.
 To maintain designed operator and patient safety, use only parts and accessories supplied with the system and
available through Mortara Instrument,Inc.
 The equipment described in this manual has an expected lifetime of five years from the date of manufacture.
Operation beyond this expected life may not meet specifications. This lifetime is only valid if devices areused
according to the instructions in this manual and associated manuals provided with theequipment.

4
SAFETY INFORMATION
 The system 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. The system is optionally equipped with Mortara’s
VERITAS™ 12-lead resting ECG interpretation algorithm. When this option is enabled, the VERITAS ECG
algorithm can provide an over-reading physician with a silent second opinion through diagnostic statements
output on the ECG report. For additional information on the Mortara VERITAS 12-lead resting ECG
interpretation algorithm, please refer to the Physician’s Guide to ECG Interpretation.
 12-lead ECGs acquired through Surveyor Central or attached monitors 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. All 12-lead ECGs printed with
Surveyor Central have a warning message that alerts the physician that the ECG might have been acquired with
torso positioned 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.
 The minimum amplitude for detecting QRS complexes is user selectable between 160, 300 and 500 µV. A low
value of this limit has the risk of detecting P waves as QRS complexes in the case of atrio-ventricular block;
however, a high value might lead to false cardiac arrest alarms if the QRS amplitude is low in all leads.
Therefore, the user is encouraged to select detection leads with amplitude of at least 1 mV and set the minimum
QRS amplitude at 300 µV.
 During periods of lead fail and when a reduced lead set is used for patient monitoring, 12-lead resting ECG
interpretation cannot be reliably used in determining adiagnosis.
 When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment cannot be
met. The 40 Hz filter significantly reduces high-frequency components of the ECG and pacemaker spike
amplitudes, and is recommended only if high-frequency noise cannot be reduced by proper procedures.
 The quality of the signal produced by the system may be adversely affected by the use of other medical
equipment connected to the patient including, but not limited to, defibrillators and ultrasound machines.
 If the system or one of its subsystems become inoperable during monitoring, a medium or low priority type
alarm sounds and a message is displayed on the screen. In case of hardware or software failure that causes the
sound generator or display subsystem to fail, the hardware watchdog unit generates a continuous beep. Periodic
checks of the monitoring screen are recommended to ensure properfunctioning.
 The LCD supplied with the Surveyor Central has a separate power switch and power-on indicator. If no image
appears on the screen, check the LCD power indicator. Alarm sounds are not affected by the status of the LCD.
Do not connect a sound-capable display monitor such as a LCD TV to the SurveyorCentral.
 The on/off switch of the Surveyor Central is deactivated and can only be used for emergency power down by
depressing it for a period greater than 4 seconds. Normal shutdown of the Surveyor Central should be done by
using the password-protected configurationwindow.
 Do not use excessive force on any of the connection cables and handle all accessories with care.
 Various alarm conditions require operator set limits that vary per patient. For telemetry monitoring,Surveyor
Central supports the selection of appropriate alarm profiles when a patient is admitted. The operator should
check these settings after each patient admission to ensure whether the chosen alarm limits are appropriate for
the individual patient. Inappropriate alarm limits render the alarm systemuseless.

5
SAFETY INFORMATION
 Saved profiles are only applicable to the type of cable and detection leads in use when the profile was defined.
If another type of cable is used with a saved profile, the default detection leads will be utilized.
 In any single environment such as an intensive care unit or cardiac operating theater, a potential hazard can
exist if different alarm preset values are used for the same or similarequipment.
 Portable and mobile RF communications equipment can affect medical electrical equipment or systems aswell
as the Surveyor Central and itsaccessories.
 Surveyor Central alarms can only be silenced and not reset. This means that visual representation of an alarm
condition remains present after an operator silenced action until the alarm condition disappears (unless obscured
by another, higher priority, alarm). The auditory alarm signal does not re-activate after a silence action if the
alarm condition remains the same. As soon as the alarm condition of a silenced alarm goes away, the alarm can
be reactivated.
 The Surveyor Central alarm system can be globally disabled or suspended for a period of time for a patient.
The selection between disabling and suspending, as well as the suspension duration, can be set in the password-
protected system configuration page. A clear visual indication of this condition is present in the patient
window, and a reminder signal sounds every three minutes. Any technical alarms will be visually presented on
the screen, regardless of the alarm disabled state. In this configuration the technical alarms will not be audible.
 The intended use of Surveyor Central Repeater is to repeat waveforms, parameters and system status of selected
patients monitored by Surveyor Central in order to enhance workflow for medical personnel. Surveyor Central
Repeater does not produce audible alarm signals and may not be used to substitute any alarm functions of
Surveyor Central.
 This manual applies to the most recently manufactured system, with respect to software release and hardware
configuration. Whenever used for software upgrades on previously installed equipment, some technical
specifications or labels may not be respected, whereas functions and instructions for use of the system are
always valid. This user manual reflects software version5.1.0.
The following warnings concern telemetry monitoring:
 Electrostatic discharges may generate short interference on the ECGtracings.
 WiFi Telemetry: The Surveyor S4 utilizes standard WiFi telemetry per the IEEE 802.11g/n standard. The
WiFi network supporting the Surveyor S4 and for use with the Surveyor Central must be installed and tested in
accordance to Mortara Instrument’s guidance and network requirements. Also refer to Mortara Instrument’s
Manufacturer Disclosure Statement for Medical Device Security (MDS2) documents for the Surveyor Central
and Surveyor S4. Mortara Instrument and/or 3rd party partners are available to perform network site surveys
and audits to confirm the suitability of the facility’s WiFi network for use with the S4 mobile monitor and
connection to the Surveyor Central and its SurveyorNetwork.
 The system was not designed to be used with high frequency (HF) surgicaldevices.
 Use of transmitters and monitors may be restricted in some countries; see the transmitter’s and monitor’s user
manuals for details.
 Consult the Surveyor S12/S19 and Surveyor S4 user manuals for more information regarding the patient cable,
electrode recommendations, cleaning, maintenance, channel frequencies, precautions to take during patient
defibrillation, and other warnings.
The following warnings concern pulse oximetry (SpO2) telemetry monitoring:
 Pulse oximetry sensors must be checked a minimum of every 4 hours and moved to a new site as necessary.

6
SAFETY INFORMATION
 Pulse oximetry sensors are susceptible to high ambient light interference including ambient photodynamic
therapy. Shield the sensor area asnecessary.
 SpO2 measurement may be adversely affected by dyes (e.g., methylene blue, indocyanine green, indigo,
carmine, fluorescein) introduced into thebloodstream.
 Any condition that restricts blood flow such as the use of a blood pressure cuff or extremes in systemic vascular
resistance may cause inability to determine accurate SpO2 readings.
 Certain conditions such as physical movement (patient and imposed motion); diagnostic testing; low perfusion;
electromagnetic interference; electrosurgical units; dysfunctional hemoglobin; and inappropriate positioning of
the pulse oximeter sensor may result in pulse oximetry readings that areunreliable.
 SpO2 signal inadequacy is indicated by error messages displayed on the LCD of the transmitter and by alarms
generated at the Surveyor Central system for signals coming from the transmitter.
 The performance of the monitor may be compromised by excessivemotion.
 Nail polish and/or artificial fingernails can affect the accuracy of pulse oximetry and should be removed.
 The pulse oximeter equipment is calibrated to display functional oxygen saturation.
 Functional SpO2 testers (simulators) are useful to measure how accurately a particular monitor is reproducing
the calibration curve but cannot be used to assess the accuracy of a type of probe or monitor. If there is
independent demonstration that a particular calibration curve is accurate for the combination of a pulseoximeter
monitor and a pulse oximeter probe, then a functional tester can measure the contribution of a monitor to the
total error of a monitor/probe system. The functional tester can then measure how accurately a particular pulse
oximeter monitor is reproducing that calibrationcurve.
 If no SpO2 or pulse rate is present, alarm conditions are provided at the Surveyor Central system. There is no
alarm condition provided at the transmittingdevice.
 For additional instructions and warnings, refer to the user manual of the transmittingdevice.
The following warnings concern heart rate for telemetry monitoring:
 Heart rate indication is usually not affected by ventricular or supraventricular arrhythmias or irregular heart
rates. Heart rate is calculated over 16 beats at rates over 40 bpm and 4 beats at lower heart rates. This resultsin
a response time of 9 seconds or less when the heart rate changes suddenly from 80 bpm to 40 or 120 bpm, as
measured according to IEC 60601-2-27.
 High heart rate and low heart rate alarms cannot bedisabled.
 Tall and peaked T-waves may affect QRS detection resulting in doubled heart rates. Surveyor Central rejects
tall T-Waves less than or equal to 230% of a 1 mV QRS measured according to IEC60601-2-27.
 The heart rate meter correctly detects all beats of the alternating beat type waveforms considered in
IEC 60601-2-27, Figure 201.101, patterns A1-A4, if the QRS amplitudes exceed the minimum detection
threshold set by the user.
 Time to low heart rate, high heart rate and asystole, as measured according to IEC 60601-2-27, is lessthan
10 seconds.
 Heart rate indication is not reliable during episodes of ventricularfibrillation.

7
SAFETY INFORMATION
 The summarized performance of the QRS recognition and classification algorithm on standard databases,
as defined by ANSI/AAMI EC 57, is as follows:
MIT Database
Performance Measures
Mortara
QRS Detection Sensitivity %
99.93
QRS Detection Positive Predictivity %
99.87
PVC Detection Sensitivity %
95.13
PVC Detection Positive Predictivity %
97.04
PVC Detection False Positive Rate %
0.220
AHA Database
Performance Measures
Mortara
QRS Detection Sensitivity %
99.78
QRS Detection Positive Predictivity %
99.91
PVC Detection Sensitivity %
93.15
PVC Detection Positive Predictivity %
98.40
PVC Detection False Positive Rate %
0.154
 Because of noise, artifact and the many different physiological manifestations of the ECG signal, it is inevitable
that some beats are not detected or correctly classified by the system. The user is advised not to rely completely
on automatic alarm systems for the monitoring of criticalpatients.
 Excessive patient movement could interfere with the operation of thesystem.
 Proper patient preparation is important to proper application of ECG electrodes and operation of thedevice.
 If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the lead(s)
where this condition is present and if the signal is being displayed or printed, the respective lead(s) will print
out as square waves. A lead fail alarm is generated on the SurveyorCentral.
The following warnings concern pacemaker patients for telemetry monitoring:
 Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some
arrhythmias. Do not rely entirely upon heart rate meter ALARM SIGNALS. Keep pacemaker PATIENTS
under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this
instrument.
 With the Surveyor S4 when used with the 4-wire, 5-wire or 10-wire ECG cable, all pacemaker spikes are
rejected per the IEC 60601-2-27 standard (0.1 - 2 msduration, 2 - 700 mV amplitude). Signals are
recognized as pacemaker spikes when they have a slew rate over 4 V/s, as measured according to the IEC
60601-2-27 standard. Abnormally high or wide pacemaker spikes might be recognized as QRS if their
amplitude and pulse width exceed thesevalues.
 With the Surveyor S4 when used with the 3-wire ECG cable, pacemaker spikes are not rejected consistently.
For this reason, do not rely upon heart rate meter ALARM SIGNALS, when using a 3-wire cable.
 Mortara Instrument does not claim, verify, or validate support for all available pacemakers.
 Consult the Surveyor S12/S19 User Manual for a description of its pacemaker spike rejection capabilities.
 The Pacemaker Rejection software can be deactivated by the user. This should not be done for patients with a
pacemaker or suspected to have a pacemaker implanted because this can lead to a heart rate indication and
failure to alarm for cardiacstandstill.

8
SAFETY INFORMATION
 Other than the influence on beat detection as stated above, there is no known safety hazard if other
equipment, such as pacemakers or other stimulators, is used simultaneously with thesystem.
Notes
 Surveyor Central contains electronic records including ECG’s which can be exported to other applications. The
Surveyor Central system can be part of a system that is compliant with the electronic records requirements of
part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21CFR
Part 11) as stipulated by the US Food and Drug Administration's (FDA). The user of the Surveyor Central
system must ensure full compliance to this as required.
 Compliance with applicable privacy and data protection guidelines, such as HIPAA in the United States and
Directive 95/46/EC of the European Parliament and the Council, plus any other local regulations and policies
are the ultimate responsibility of the entity deploying and using the Surveyor Central. The Surveyor Central
system implements certain features such as username/passwords and audit trails. By-design, the system is
accessible and available for use upon power-up. The facility deploying and using the system is responsible for
ensuring appropriate safeguards are put in place to protect patient health information (PHI). This includes a
mixture of physical and IT-based mechanisms to secure PHI from unauthorized access. The Surveyor Central
Station including printers generating reports must be placed in a physical location that is secure (e.g., nurse’s
station). Surveyor Review and Repeater stations may be placed in less secure locations but must implement
proper username/password access policies asrequired.

9
2. EQUIPMENT SYMBOLS AND MARKINGS
WARNING The warning statements in this manual identify conditions or practices that could lead to
illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates
defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black
and white document.
CAUTION The caution statements in this manual identify conditions or practices that could result in
damage to the equipment or other property, or loss of data.
Follow operating instructions
Direct Current (DC) power input
Indicates compliance to applicable European
Union directives
Universal Serial Bus (USB) port
Do not dispose as unsorted municipal waste.
Requires separate handling for waste disposal
according to local requirements
Output terminal
Network connection
Mouse Connection
Serial Port Connection
ON (Power)
Keyboard Connection
Parallel Port Connection
Product Lifetime
Mortara intends to support the Surveyor Central Processing Unit, monitors, transmitters and proprietary antenna
network components most current version, for not less than three (3) years beyond the date of the last unit produced
of that revision, or for as long as parts, accessories and expertise are available from our vendors, subject to last time
buys and technology obsolescence.

EQUIPMENT SYMBOLS AND MARKINGS
10