Mortara S12 User manual

TABLE OF CONTENTS
1
REF 9516-183-50-ENG Rev M
S12/S19
SURVEYORPATIENTMONITORS
SERVICE MANUAL
Manufactured byMortara Instrument, Inc., Milwaukee, WisconsinU.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Copyright © 2018
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee,Wisconsin53224
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. Surveyor™, AM12M™, and VERITAS™are
trademarks of Mortara Instrument, Inc.
Nellcor™, Covidien™, C-LOCK™, SatSeconds™, OxiMax™,MAX™, Max-Fast™, SoftCare™, Oxiband™, Dura-
Y™, PediCheck™, OxiCliq™, and Durasensor™ are trademarks of Nellcor Puritan Bennett Inc.
Smart Capnography™, Smart Breath Detection Algorithm™(BDA™), Smart Alarm Respiratory Analysis ™
(SARA), Integrated Pulmonary Index™ (IPI), Microstream®, Filterline® and Capnoline® are trademarks or
registered trademarks of Oridion MedicalLtd.
Edwards® is a registered trademark of Edwards Lifesciences Corporation.
Oridion CO2 License Information -- NO IMPLIED LICENSE –Possession or purchase of this bedside monitor
does not convey any express or implied license to use the bedside monitor with unauthorized consumable CO2
sampling products which would, alone, or in combination with this bedside monitor, fall within the scope of one or
more patents relating to this bedside monitor and/or CO2 sampling consumable products.
The capnography component of this product is covered by one or more of the following US patents: 6,428,483;
6,997,880; 6,437,316;7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending.
All other trademarks and registered trademarks are the property of their respective owners.
For patent information, please visit www.welchallyn.com/patents

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TABLE OF CONTENTS
1. GENERAL STATEMENTS ...........................................................................................................................1
TECHNICAL SUPPORT AND SERVICE ................................................................................................................................ 1
2. NOTICES ....................................................................................................................................................2
M ANUFACTURER ’ S R ESPONSIBILITY ..................................................................................................................... 2
R ESPONSIBILITY OF THE C USTOMER ................................................................................................................... 2
E QUIPMENT I DENTIFICATION ............................................................................................................................ 2
C OPYRIGHT AND T RADEMARK N OTICES ............................................................................................................ 2
O THER I MPORTANT I NFORMATION .................................................................................................................. 2
3. WARRANTYINFORMATION ....................................................................................................................3
Y OUR M ORTARA W ARRANTY ............................................................................................................................. 3
4. USERSAFETYINFORMATION ..................................................................................................................5
S AFETY R EGULATIONS ......................................................................................................................................... 5
WARNINGS ............................................................................................................................................................... 5
POWERWARNINGS..................................................................................................................................................... 6
ACCESSORIES,CABLES,AND EXTERNAL CONNECTIONS WARNINGS......................................................................................... 8
USE WITH ELECTRO SURGERY DEVICES WARNINGS............................................................................................................. 9
INSTALLATION AND MOUNTING WARNINGS ..................................................................................................................... 9
ECGWARNINGS ........................................................................................................................................................ 9
ECG CALCULATED HEART RATE WARNINGS .................................................................................................................. 10
WARNINGS FOR PATIENTS WITH PACEMAKERS ................................................................................................................ 11
RESPIRATIONWARNINGS............................................................................................................................................ 11
SPO2WARNINGS..................................................................................................................................................... 11
NIBPWARNINGS ..................................................................................................................................................... 13
INVASIVE PRESSURE WARNINGS................................................................................................................................... 14
CO2WARNINGS ...................................................................................................................................................... 14
CARDIAC OUTPUT WARNINGS ..................................................................................................................................... 14
CAUTIONS............................................................................................................................................................... 16
N OTES ................................................................................................................................................................. 17
5. EQUIPMENTSYMBOLSANDMARKINGS ............................................................................................19
S YMBOL D ELINEATION ....................................................................................................................................... 19
6. ELECTROMAGNETIC COMPATABILITY (EMC) ...................................................................................21
TABLE X-1GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC EMISSIONS.................................................. 22
TABLE X-2GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY.................................................. 22
TABLE X-3GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY.................................................. 23
TABLE X-4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE
EQUIPMENT ............................................................................................................................................................ 24
7. GENERAL CARE AND MAINTENANCE ................................................................................................25
P RECAUTIONS .................................................................................................................................................... 25
I NSPECTION ........................................................................................................................................................ 25
C LEANING ............................................................................................................................................................ 25
M AINTENANCE ................................................................................................................................................... 28
B ATTERY R EPLACEMENT .................................................................................................................................... 33
BATTERY LIFE AND CHARGE TIME ................................................................................................................................. 33

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BATTERYCONDITIONS................................................................................................................................................ 34
D ECOMMISSIONINGAND D ISPOSAL ................................................................................................................... 34
C ALIBRATION ...................................................................................................................................................... 34
CO2CALIBRATION.................................................................................................................................................... 34
INVASIVE PRESSURE CALIBRATION................................................................................................................................. 35
NIBPCALIBRATION................................................................................................................................................... 35
S12/S19 P REVENTATIVE M AINTENANCE R ECORD .......................................................................................... 36
8. DEVICESETUP .........................................................................................................................................38
O VERVIEW .......................................................................................................................................................... 38
P ATIENT I NFORMATION ................................................................................................................................... 38
P ARAMETERS ...................................................................................................................................................... 38
W AVEFORMS ...................................................................................................................................................... 39
R ECORDER ........................................................................................................................................................... 41
A RRHYTHMIA ..................................................................................................................................................... 42
A LARM S USPEND ................................................................................................................................................ 43
A LARMS ............................................................................................................................................................... 43
A UDIO ................................................................................................................................................................. 45
R ESTORE D EPARTMENTAL D EFAULTS ............................................................................................................... 46
A DMINISTRATION .............................................................................................................................................. 46
CONFIGURATION ...................................................................................................................................................... 47
COMMUNICATIONS................................................................................................................................................... 47
SCREENCLEANING .................................................................................................................................................... 48
ADMINISTRATION SETUP ALARMS DIALOGUE.................................................................................................................. 48
ADMINISTRATION SETUP SYSTEM DIALOGUE................................................................................................................... 50
ADMINISTRATION SETUP SERVICE DIALOGUE .................................................................................................................. 51
ADMINISTRATION SETUP FACTORY DIALOGUE................................................................................................................. 51
9. UNIT DISSASSEMBLY .............................................................................................................................52
B ATTERY R EMOVAL & R EPLACEMENT ............................................................................................................. 55
R EAR H OUSING R EMOVAL & R EPLACEMENT .................................................................................................. 56
P ROCESSOR B OARD R EMOVAL & R EPLACEMENT ........................................................................................... 59
M AIN B OARD R EMOVAL & R EPLACEMENT ..................................................................................................... 60
LCD R EMOVAL & R EPLACEMENT S12 ................................................................................................................ 62
LCD R EMOVAL & R EPLACEMENT S19 ................................................................................................................ 63
R EMOVAL AND R EPLACEMENT OF THE O PTIONAL T HERMAL W RITER (S12 ONLY) .................................. 65
O PTIONAL T HERMAL W RITERFORTHE S19 ...................................................................................................... 68
10. CONFORMANCE TESTING .................................................................................................................79
REQUIREDEQUIPMENT: ............................................................................................................................................. 79
1.0POWERTESTING.......................................................................................................................................... 80
2.0 FUNCTIONALTESTING ................................................................................................................................... 80
3.0 DEVICECLEANING ...................................................................................................................................... 108
4.0 SAFETYTESTING......................................................................................................................................... 109
11. PRODUCT SPECIFICATIONS ..............................................................................................................113
G ENERAL S PECIFICATIONS ............................................................................................................................... 113
E NVIRONMENTAL C ONDITIONS ...................................................................................................................... 113
P OWER R EQUIREMENTS & B ATTERY .............................................................................................................. 114
D ISPLAY S PECIFICATIONS ............................................................................................................................... 114
R ECORDER S PECIFICATIONS ............................................................................................................................ 114
M OUNTING S PECIFICATIONS ......................................................................................................................... 115
T RENDING ......................................................................................................................................................... 115

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12. PARAMETER SPECIFICATIONS ..........................................................................................................116
P ATIENT P OPULATION .................................................................................................................................... 116
W AVEFORMS .................................................................................................................................................... 116
ECG .................................................................................................................................................................... 116
A RRHYTHMIA A NALYSIS .................................................................................................................................. 117
ST A NALYSIS ..................................................................................................................................................... 118
N ON -I NVASIVE B LOOD P RESSURE (NIBP) ...................................................................................................... 119
P ULSE O XIMETRY (S P O2) ................................................................................................................................ 119
T EMPERATURE .................................................................................................................................................. 120
R ESPIRATIONS : V IA ECG I MPEDANCE ............................................................................................................ 120
C APNOGRAPHY (CO2) ....................................................................................................................................... 120
I NVASIVE P RESSURES ........................................................................................................................................ 121
C ARDIAC O UTPUT ............................................................................................................................................ 122
13. PARAMETERALARM LIMIT RANGES .............................................................................................124
A DULT P ATIENT M ODE ................................................................................................................................... 124
P EDIATRIC P ATIENT M ODE ............................................................................................................................. 126
14. ALARMSPECIFICATIONS .................................................................................................................128
G ENERAL A LARMS ........................................................................................................................................... 128
ECG AND HR M ESSAGES ................................................................................................................................. 128
N ON -I NVASIVE B LOOD P RESSURE (NIBP) M ESSAGES ................................................................................... 129
P ULSE O XIMETRY (S P O2) M ESSAGES ............................................................................................................. 131
T EMPERATURE M ESSAGES ............................................................................................................................... 132
R ESPIRATION M ESSAGES .................................................................................................................................. 133
C APNOGRAPHY (CO2) M ESSAGES .................................................................................................................. 134
I NVASIVE P RESSURE M ESSAGES ....................................................................................................................... 135
C ARDIAC O UTPUT M ESSAGES .......................................................................................................................... 136
NETWORK MESSAGES ............................................................................................................................................. 136
15. TROUBLESHOOTING .......................................................................................................................137
P OWER AND B ATTERY ..................................................................................................................................... 137
D ISPLAY AND T OUCH S CREEN ......................................................................................................................... 137
ECG, A RRHYTHMIA , AND ST ........................................................................................................................... 138
N ON -I NVASIVE B LOOD P RESSURE (NIBP) ...................................................................................................... 138
P ULSE O XIMETRY (S P O2) ................................................................................................................................ 139
T EMPERATURE .................................................................................................................................................. 139
R ESPIRATIONS : V IA ECG T HORACIC I MPEDANCE ......................................................................................... 139
C APNOGRAPHY (CO2) ....................................................................................................................................... 139
I NVASIVE P RESSURES ........................................................................................................................................ 140
C ARDIAC O UTPUT ............................................................................................................................................ 140
16. MOUNTING ACCESSORIES ..............................................................................................................144
Q UICK D ISCONNECT (M-S ERIES ) W ALL M OUNTING C OMPONENTS .............................................................. 144
V ALUE (V ESA M-S ERIES ) W ALL M OUNTING C OMPONENTS ........................................................................... 144
P REMIUM (VHM-25) W ALL M OUNT C OMPONENTS .................................................................................... 145
S URVEYOR S12 R OLL S TAND C OMPONENTS ( NOTTOBEUSEDWITH S19) .................................................... 146

TABLE OF CONTENTS
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1
1. GENERAL STATEMENTS
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.mortara.com
European Union
Representative
Via Cimarosa, 103/105
40033 Casalecchio di Reno (Bologna)
Italy
Tel: [phone]
Fax: [phone]
E-mail: clienti.mortarait @welchallyn.com
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)(USA)
Fax: [phone]
E-mail: [email protected]m
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]
E-mail: [email protected]m
Hospital Customers: o[email protected]m
Physician Practice:[e-mail]
U.S. Distribution: or[email protected]m
Mortara InstrumentGermany
Hofgartenstraße 16
72379 Hechingen
Germany
Tel.: [phone]
Fax: [phone]
E-Mail: info @ welchallyn.com
MortaraInstrumentNetherlands
“Amerika” Gebouw– 7e verdieping
Hoogoorddreef 15
1101 BA Amsterdam
Netherlands
Tel.: [phone]
E-mail: infonl @ welchallyn.com
Mortara InstrumentAustralia
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]

2
2. NOTICES
Manufacturer’s Responsibility
Mortara Instrument, Inc. is responsible forthe effects on safetyand performance of the patient monitor, as indicated
bythe label, only if article 2 of 93/42/EEC directive is applied, in particular:
WARNING: System installation and assemblyoperations, extensions, readjustments, modificationsor
repairs are carried out bypersonnel authorized byMortara Instrument, Inc. only.
 The patient monitor is used in accordance with the instructionsfor use.
 The patient monitor iscorrectlymaintained accordingto thestandardsauthorized byMortara Instrument, Inc.
using original spareparts.
 The patient monitor isused with original accessories and supplies that are in compliance with the standard
specificationsdescribed in this manual.
 Theelectricalinstallation of therelevantroomcomplies with therequirementsof appropriateregulations.
Responsibility of the Customer
The user of this patient 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 Instrument, Inc. authorized personnel must
have access to this manual at any time.
The user of this patient monitor must periodically check the accessories, their functionality and integrity.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the patient 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 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 anyerrors or omissions that mayappear in this document. Mortara Instrument, Inc. makes no
commitment to update or to keep current the information contained in this document.

3
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 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) Freightdamage;
b) Supplies, accessories and internal parts NOT approved by Mortara;
c) Misapplication,misuse, abuse, and/or failuretofollowtheProduct/sinstruction sheetsand/or information
guides;
d) Accident;
e) A disaster affecting theProduct/s;
f) Alterationsand/or modifications to theProduct/s not authorized by Mortara;
g) Otherevents outside of Mortara’s reasonable controlor not arising under normal operating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENTWITHOUT
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 warrantywill 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/swhen sold.

4
WARRANTY INFORMATION
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 A N D M O R T A R A 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 OFMERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE.

5
4. USER SAFETY INFORMATION
Warning: Means there is the possibilityof personal injury to you or others.
Caution: Means there is the possibilityof damage to the patient monitor.
Note: Provides information to further assist in the use of the patient monitor.
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.
Safety Regulations
 Surveyoris a medical patient monitor.
 Surveyor and its accessories are labeled, according to European directive 93/42/EEC (MDD), as a class
IIb patient monitor,andclass I medical patient monitors respectively.
 Surveyor with all accessories that have a physical or logical connection with it, forms part of a Medical
ElectricalSystem. Surveyor complieswith varioussafetyand performanceregulationsas mentioned in this
manual(AppliedStandards).
Warnings
 This manual gives important information about the use and safety of this patient monitor. Deviating from
operating procedures, misuse or misapplication of the patient monitor, or ignoring specifications and
recommendations could result in increased risk of harm to users,patients and bystanders, or damage to the
patientmonitor.
 Users are expected to belicensed clinicalprofessionals knowledgeable about medical proceduresand patient
care, and adequately trained in the use of this patient monitor. Patient 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’sdiagnosis.
 Before attempting to use this device forclinical applications,theoperator must read andunderstand 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 patient monitor. Contact Mortara
Technical Service for additionaltraining options.
 The patient monitorprovides thepossibilityto monitormultiple functions, but is not intended to be connected to
more than onepatient.
 Operationofthe equipment beyond itsspecified ranges, or beyondnormal physiological conditions ofhuman
subjects, may cause inaccurate results.
 To ensure the safetyof both the patient and the device, 1.5 meters (5’) of open area should surround the patient.

USER SAFETY INFORMATION
6
 A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
Do not mount anypart of the device closer than 25 cm from outlets of flammable gases, includingoxygen.
 For proper operation and the safetyof users or patients and bystanders, equipment and accessories must be
connected onlyas described in thismanual.
 Repairs and modification must be made byauthorized and trained technical personnel. Unauthorized
modifications and repairs will void the Surveyor warranty and maypose a danger to patients and users.
 If additional devices beyond Surveyor are connected to the patient, leakage currents through the patientmight
add up and should be accountedfor.
 The Surveyor, as all medical equipment or systems, needs special precautions regarding EMC and needs to be
installed and put into service accordingto the EMC information provided in the installationprocedure in order
to obtain a sufficient degree of immunity as well as not to create disturbance to other equipment. Refer to the
specificEMC instructionsinthismanual.
 The quality of the signal produced by the device maybe adversely affected bythe use of other medical
equipment, includingbut not limited to electrosurgeryand ultrasound machines. Do not use the systemin the
presence of imaging equipment such as magnetic resonance imaging (MRI) and tomography systems.
Simultaneousoperation maydamage the device orlead to erroneousresults.
 Portable and mobile RFcommunications equipment mayaffect medical electrical equipment or systems as
well as the Surveyor and its accessories. Do not operate the Surveyor near high frequency emissions (e.g.
microwaves).
 Various alarm conditions require operator to adjust alarm configurations individualized according to patient
condition and demographics. Surveyor supports the selection of appropriate alarm profiles when a patient is
admitted. The operator should check these settings with each patient admission to ensure the alarm settings are
appropriate for the individual patient. Inappropriate alarm configuration settings may render the alarm system
useless.
 Surveyor 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 level, 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. Always respond promptly toalarms.
 Apatient monitor is an addition to monitoringpatient status and is not intended to replace clinical assessments
and clinical judgments. It is important that a qualified individual regularly supervise the patient.
 In an environment where multiple systems,whetherSurveyorand/or othersystems,areutilized for monitoring
patients, use of different alarm presets on each system may pose a safety risk. Be careful in using different
alarmconditionsondifferentsystems.
Power Warnings
 Only use the Mortara-provided external power adapter with the Surveyor. Ensure that the power adapter is
connected to a properly grounded power terminal and the electrical installation complies with local safety
requirements for theenvironment whereit is used.
 To ensure that electrical safetyis maintained duringoperationfromAC power, the Surveyor external power
adapter must be plugged into a hospital-grade outlet.
 Where the integrityof external protective earth conductor arrangement is in doubt, the device shall be operated
from its internal battery power source.
 Do not use the Surveyor power supplyto power other devices, because of the risk ofadditional leakage currents

USER SAFETY INFORMATION
7
and of transformeroverload.
 The device is not operative if no image appears on the screen. If the device becomes inoperative during
monitoring, a medium leveltypealarmsounds and thesystemresets automatically.
 Regularly check all mains power cables for damage and proper connection. Do not use equipment with a
damaged powercord.
 TheSurveyorcontains a lithium ion battery. The following precautionsshould be taken regarding thebattery:
o Do not immerse the device in water.
o Do not heat or throw the device infire.
o Do not leave the in conditions over 60 ºC or in a heatedcar.
o Do not attempt to crush or drop thedevice.
o Only use the approved Mortara batterypack with the Surveyor monitor.
o Followthe instructions in the disposal section of this manual when the Surveyor monitor is taken out of
service.
 The Surveyor battery must be initially fully charged prior to use. Ideally, the battery must be fully charged and
fullydischarged several timesto allowfor optimalperformance.
 The Surveyor produces audible startup tones when powered on (two tones followed by two higher beeps). If a
patient monitor does not sound the startup tones when it ispowered on, remove the patient monitor from service
and contact Mortara TechnicalSupport.
 If the AC power supply is interrupted or disconnected during monitoring, the Surveyor switches to battery
backup if the battery is properly installed and has sufficient charge. If power is completely interrupted,
includingexhausting the batterysupply, monitoring will cease until AC powersupplyhas been restored or a
fresh batteryis installed, and themonitor’s power switch isrecycled.
 Forcontinued operation, always connect the Surveyor to a wall outlet when a LowBatteryalarm indication
occurs. Failure to do this can lead to an interruption of monitoring.
 Ensure the batteryhas sufficient charge prior to disconnecting the external power supply. To disconnect from
the AC power, disconnect the external power adapter from AC power first, then disconnect the power
connection from the back of the monitor.
 Always reconnect the power cord to AC power after operating the patient monitor using battery power. This
ensures that the batteries are recharged for the next time the patient monitor is operated on battery power. A
light next to the on/off switch will illuminateindicating that the patientmonitor is connected to mainspower and
charging. The batteryicon on the main displayindicates when the batteryis fullycharged.

USER SAFETY INFORMATION
8
Accessories, Cables, andExternal Connections Warnings
 The patient monitor 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 and may pose
possible patient and user safetyconcerns.
 It is the user’s responsibility to use only approved supplies, accessories and internal parts available through
Mortara Instrument, Inc. Product performance and patient safety require the use of supplies, accessories and
internal parts that comply with applicable standards. To maintain designed operator and patient safety,
peripheral equipment and accessories used that can come in direct patient contact must be in compliance with
applicable standards including IEC 60601-1, or other IEC standards (e.g., IEC 60950) as appropriate to the
patient monitor. Additionally, cables and accessories must comply with all EMC regulations. In Europe, cables
and accessories should bear the CE Mark. Only use parts and accessories supplied with the patient monitor and
availablethroughMortaraInstrument,Inc.
 Connected devices must stay outside of the patient environment, and must be electrically insulated from the
Surveyor bya separation device, or alternatively a permanent additional safety ground must be attached to the
Surveyor using the appropriate terminal at the back of the unit. Connecting additional devices to the patient
monitor may increase chassis and/or patient leakage currents. To maintain operator and patient safety,
consideration should begiven to the requirements of IEC 60601-1-1, and leakage currents should be measured
to confirm no electric shock hazard exists.
 Do not use excessive force on anyof the connection cables and handle all accessories with care.
 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 are intended for
short-termuse and should beremoved fromthe patientpromptlyfollowingtesting.
 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
patient monitor or patient cables. Additionally, proper placement of defibrillator paddles in relation to the ECG
electrodes isrequired to minimize harmto the patient.
 To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes, IBP
catheters, disposable SpO2 sensors, disposable temperature sensors, single-use blood pressure cuffs, etc.) must
not be reused.
 Mortara-approved manufacturersof accessories provideseparateuser manuals (e.g.,patient cables, electrodes,
etc.). Read these manuals thoroughly and refer to them for specific functions. It is recommended to keep all
manualstogether.

To maintain safetyand effectiveness, reusable sensors and cables - such as ECG electrodes and SpO2 sensors -
must not be used beyond their expiration dateor useful life.
 All accessories including hoses, cables, connectors, hoses and other patient-applied parts supplied with the
Surveyor do NOT contain any Latex. If the patient develops an allergic reaction or rashes, immediatelyremove
the accessory and inform Mortara Technical Support.
 Check the date and integrityof the packing of all accessories that need to be sterilized before use.
 Do not attach unauthorized devices such as a mouse or keyboard to the USB port.
 Do not attach unauthorized patient cable for use with AM12M. Patient cable should provide locking mechanism
to matingdevice.

USER SAFETY INFORMATION
9
Use with Electro Surgery Devices Warnings
 The Surveyor is approved for use in the presence of electrosurgical (ESU) equipment providing the following
precautions aretaken:
o To minimize the risk of patient burns, only use ESU equipment that monitors the impedance of the ESU
returnwires.
o Users should be properlytrained in the operation of the ESU equipment.
o TheAM12M 12-Lead ECG Acquisition Module should NOT be used when operating ESU equipment.
o Keep patient-applied cables (e.g., ECG lead wires) off of earth ground and awayfrom the ESU knife and
return wires to prevent burnsto measurement sites.
o To prevent burns to the patient in the event of a defective neutral ECG electrode of the device, it is
necessaryto place ECG electrodes far from the neutral electrode, and as equidistant as possible fromthe
blade-neutralaxis of the surgicalpatient monitor.
o When activating the ESU device, the ECG signals maybe distorted or maydisappear, and Lead Fail or
Noise alarms might be present. The signal should return once the ESU activationstops.
o When activating the ESU device, using the SpO2 parameter as the heart rate source rather than the ECG
parameter to determine heart rate maybe clinicallypreferred.
Installation and Mounting Warnings
 Place the Surveyor on a flat and leveled surface or mount it according to the manufacturer’s instructions. Place
the Surveyor in a well-ventilated place. Keep the Surveyor away from overly hot, cold or humid places, places
directlyundersunlight,ordustysurroundings.
 Ensure that the Surveyor is securelyplaced or mounted such that it does not tip or drop which maydamage the
monitor and potentiallycreate a hazard to patients and hospitalpersonnel.
 Onlyapproved rolling standsand wall-mountfixturesshould beused with the Surveyor.
 AVESA-standard adapter is available onthe back of the Surveyor systemfor wall, swivel-armor rolling-stand
mounting. The user is responsible for correct installation of thesystem.
 Do not mount the S12 on a rolling stand at a height exceeding 110 cm (43”).
 The S19 should NOT be mounted on a rollingstand.
ECG Warnings
 Excessivepatientmovement could interferewith theoperationofthe system.
 Proper patient preparation is important to proper application of ECG electrodes and operation of the patient
monitor.
 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 orprinted, the respective lead(s) will print out
as blank. A lead fail alarm is generated on the Surveyor Central monitoringstation
 The AM12M acquisition module automaticallycalibrates when it is connected to the monitor or when the
monitor powers up. If there is a very high amount of electrical interference present at that time (usually because
electrodes make spurious contact with earth ground), the calibration mayfail. The monitor is aware of the failure
and will not display the ECG waveforms. If this happens, the user should attempt to recalibrate by reconnecting
the AM12M to the monitor, making sure that there are no spurious contacts between electrodes and earth
ground.
 Patient cables intended for use with the patient monitor include series resistance (9 Kilo Ohmminimum) in each
lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.
 ECGelectrodes could cause skin irritation;patients should be examined for signs of irritation or inflammation.

USER SAFETY INFORMATION
10
 Defibrillation protection isguaranteed when the originalMortaraECG patient cables areused.
 The system captures and presents data reflecting a patient’s physiological condition that when reviewed bya
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 equipped with Mortara’s VERITAS™ 12-lead
resting ECG interpretation algorithm. The VERITAS ECG algorithm can provide an over-reading physician
with a silent second opinionthrough diagnostic statements output on the ECG report.
 12-lead ECGs acquired through Surveyor 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 ECGsprinted with Surveyor 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 thepossibilityof motion artifact.
 During periods of lead fail and when a reduced lead set isused for patient monitoring, 12-lead resting ECG
interpretationcannot be reliablyused indetermining a diagnosis.
 For full diagnostic quality, the resting ECG should be printed on the Surveyor Central Station printer and not on
the S12 or S19 strip chartrecorder.
ECG Calculated Heart Rate Warnings
 Heart rate indication is usually not affected bypacemakers with direct cardiac application, ventricular or
supraventricular arrhythmias orirregularheart rates; however, insomeconditionsa pacemaker pulse can give
rise to double QRS detections. Also, not activating the “Analyze Pacers” field in the signals menu in the
presence of a pacemaker might lead to beat detections without a QRS complex due to the detection of the
pacemakerspike.
 Heart rate is calculated over 16 beats at rates over 40 bpm and 4 beats at lower heart rates. This results in 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 ANSI/AAMI EC13 and IEC60601-2-27.
 Tall and peaked T-waves may affect QRS detection resulting in doubled heart rates. Surveyor rejectstall
T-Waves less than or equal to 240% of a 1mV QRS in diagnostic mode, and 70% of a 1mV QRS in monitoring
mode, as well as a Q-T interval of 350 ms measured for both diagnostic and monitoring modes according to
ANSI/AAMI EC13 and IEC 60601-2-27.
 The heart rate meter correctly detects all beats of the alternating beat type waveforms considered in
ANSI/AAMI EC 13 and IEC 60601-2-27 Figure 201.101 patterns A1-A4 if the QRS amplitudes exceed the
minimumdetection threshold set bythe user.
 Time to tachycardia, as measured according to ANSI/AAMI EC13 and IEC 60601-2-27 Figure 201.101 patterns
B1-B2 is less than 8seconds.
 Heart rate indication isnot reliable duringepisodes of ventricularfibrillation.
 Thesummarized performance ofthe QRS recognition and classification algorithmon standard databases,as
defined by ANSI/AAMIEC 57, is as follows:

USER SAFETY INFORMATION
11
MITDatabase
PerformanceMeasures
Mortara
QRS Detection Sensitivity %
99.94
QRS Detection Positive Predictivity %
99.87
PVC Detection Sensitivity %
95.49
PVC Detection Positive Predictivity %
97.05
PVC Detection False Positive Rate %
0.220
AHADatabase
PerformanceMeasures
Mortara
QRS Detection Sensitivity %
99.86
QRS Detection Positive Predictivity %
99.90
PVC Detection Sensitivity %
93.49
PVC Detection Positive Predictivity %
98.32
PVC Detection False Positive Rate %
0.162
 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
onautomaticalarmsystems for themonitoring of critical patients.
Warnings for Patients with Pacemakers
 Rate meters maycontinue to count the pacemaker rate during occurrencesof cardiac arrest orsome arrhythmias.
Do not rely entirely upon rate meter alarms. Keep pacemaker patients under closesurveillance.
When using the 3/5 lead ECG cable, pacemaker spikes are normally recognized and rejected by the software.
Signals are recognized as pacemaker spikes when they have a slewrate over 1.4 V/s, as measured accordingto
the ANSI/AAMI EC 13 and IEC 60601-2-27standards.
 When using the AM12M 12-lead ECG Acquisition Module,pacemaker spikes in the range of 0.3 to 1.3 mS, +/-
2 to +/-700 mV are recognized and rejected according to the ANSI/AAMI EC13 and IEC 60601-2-
27:2011standards.
 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 cardiacarrest.
Other than the influence on beat detection as stated above, there is no known safetyhazard if other equipment,
suchaspacemakers orother stimulators, isused simultaneouslywith thesystem.
RespirationWarnings
 When using an ECG electrodeto calculate respiration rate via the thorax impedance method,movement artifacts
may create inaccurate results. Respiration rates derived from CO2 parameter is not subject to such movement
artifacts.
SpO2 Warnings
 Use only approved pulse oximetry sensors specifically intended for use with the patient monitor. Unapproved
componentscanresult indegradedperformanceand/or devicemalfunction.
 Use pulse oximetrysensors specified for the correct patient modeand for the correct application position.
 Pulse oximetrysensors must be checked a minimum of every4 hours and moved to a new site as necessary.
Reposition the sensor at least once every24 hours to allow the patient’s skin to breathe.
 Tissue damage or inaccurate measurements maybe caused byincorrect SpO2 sensor applicationor use, such as

USER SAFETY INFORMATION
12
wrapping too tightly, applying supplemental tape, failing to inspect periodically, or failing to position
appropriately. Read the Instructions for Use provided with the SpO2 sensor carefully prior touse.
 Do not sterilize or immerse pulse oximetry sensors in liquid. Clean and/or disinfect re-usable sensors between
patients.
 Pulse oximetry sensors are susceptible to high ambient light interference including surgical lights, especially
xenonlight sources, ambient photodynamic therapy(e.g., Bilirubin lamps), fluorescent lights, infrared heating
lamps, direct sunlight. Shield the sensor area as necessary.
 SpO2 measurementmaybeadverselyaffected bydyes(e.g., methyleneblue, indocyanine green, indigo,
carmine,fluorescein)introducedinto thebloodstream
 That factors that maycause inaccurate readings and alarms, decreased perfusion, and orlowsignal strength
include:
Interferingsubstances:
o CarboxyhemoglobinmayerroneouslyincreaseSpO2reading.
o Methemoglobin (MetHb) usually represents less than 1% of the total Hgb, but in the case of
methemoglobinemia that can becongenital orinduced bysome IV dyes, antibiotics (such as sulphas,)
inhaled gases etc. this level increases sharply and thus can confound the SpO2reading.
o Intravasculardyes(suchas indocyaninegreen,methyleneblue, etc.).
Physiological conditions:
o Cardiac arrest
o Hypotension
o Shock
o Severevasoconstriction
o Severeanemia
o Hypothermia
o Venouspulsations
o Ventricular septal defects(VSDs)
Sensorplacement:
o Incorrect sensorplacement
o Poor sensor fit
 Anycondition that restricts blood flow such as the use of a blood pressure cuff or supplemental tape, or
extremesin systemicvascular resistancemaycause inabilityto determine accurateSpO2 readings.
 Certain conditions suchasphysicalmovement(patient and imposed motion);diagnostictesting;lowperfusion;
electromagnetic interference; electrosurgical patient monitors; dysfunctional hemoglobin; and inappropriate
positioning of the pulse oximeter sensor mayresult in pulse oximetryreadings that are unreliable.
 SpO2 signal inadequacyis indicated by error messages or alarms generated at theSurveyor patient monitors.
 If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs, and then
check for conditions that may cause inaccurate SpO2 readings. If the problem is still not resolved, check the
monitor and the SpO2 module, cable, orsensor for proper functioning.
 A pulse oximeter is not an apnea monitor. A pulse oximeter should be considered an early warning device. As a
trend toward patientdeoxygenation isindicated, blood samplesshould beanalyzed bya laboratory CO-oximeter
to completely understand the patient’s condition. Check that the pulse oximetry waveform is physiological in
shape.
 To prevent erroneous readings, do not use physically damaged sensors, cables ormodules. Discard a damaged
sensoror cableimmediately.
 The performance of the pulse oximetry may be compromised byexcessive motion includingtremors or

USER SAFETY INFORMATION
13
shivering.
 Nail polish and/or artificial fingernails can affect theaccuracyof pulseoximetryand should be removed.
 Pulse rate measurement is based on the optical detection of a peripheral flow pulse. While a pulse rate does
assist with the detection or absence of a peripheral pulse, the pulse oximeter should not be used as a replacement
orsubstituteforECG-basedarrhythmiaanalysis.
 In certain situations such as lowperfusion or weak signal strength, such as with patients who have pigmented or
thick skin, inaccurate SpO2 measurements may be reported. Verification of oxygenation should be made
through other means, particularly in preterm infants, and patients with chronic lung disease, prior to instituting
anytherapy orintervention.
 Always monitor ECG for arrhythmia detectionpurposes.HR calculated frompulsatile SpO2 waveformmay
differsignificantlyfromECG HRmeasuredvalues.
NIBP Warnings
 Useonlyapproved blood pressure (BP) cuffs specificallyintended foruse with the Surveyor patient monitors.
 Use the correct size cuff for the intended limb (see indication of cuff size in cm printed on cuff) of the patient.
The terminology printed on some BP cuffs like “child,” “adult,”“thigh,”etc., is only an indication of the size of
the cuff and should not be used to determine if the cuff is suitable for the limb. Use the range markers on the BP
cuff’s to determine whether a particular cuff fits the patient’sarmor not.
 The Surveyor patient monitor is not intended for use with neonates.
 Do not fold, clamp, cut, or alter the pressure hose of the cuff or the monitor.
 Periodically check the limb connected to the cuff for adequate perfusion, circulation, and function. Repeated
NIBP measurements can lead to hematomas, limb ischemia, and other limb injuries. Kinked or blocked hoses
can lead to prolonged impairment ofblood circulation and lead to injury.
 Educate the patient to relax, rest, and lie still during inflation and pressure measurements. Patient movement can
lead to artifacts orerrors.
 Thepressure measurement might beinfluencedbypatientposition,physicalconditions, and otherfactors.
 Avoid placing the blood pressure cuff on the arm next to where a patient has had a mastectomy.
 Avoid applying the cuff to a wounded limb as this can cause further injury. Use with caution in patients with
dermatologicaldisease, subcutaneous laceration, orotherintegumentarycompromiseasthere mayexist a skin
damage hazard during electronic NIBP measurements. Follow prudent evidence-based clinical practice to
determine if an electronic blood pressure is safe for these patients.
 There maybe an increased risk of hematomas in patients with serious coagulation problems.
 Avoid applying the cuff to a limb with a catheter, arterio-venous shunt or infusion pump applied. The cuff
pressure could produce damage to the tissues surrounding the catheter, shunt or the infusion needle, or
compromise the infusion flow.
 To avoid the potential for spread ofdisease or infection, reusable blood pressure cuffs should be cleaned after
each patient use. Disposable blood pressure cuffs should not be used with multiplepatients.
 Inflation of the NIBP cuff can cause a temporary degradation of monitoring of other parameters derived from
the same limb, including invasive pressure and SpO2 measurements. If applicable, place the SpO2 sensor and
the NIBP cuff on differentlimbs.

USER SAFETY INFORMATION
14
 An irregular heart beat (arrhythmia) causes beat-to-beat blood pressure variations and may therefore disturb
the NIBP measurement, which may fail or be inaccurate. It is advisable to confirm automatic NIBP
measurements periodically for patients with frequent premature beats or a very irregular heart rate, for example
caused by atrial fibrillation.
 NIBP measurements may be inaccurate or fail in the presence of excessive movement, shivering, or trembling.
Advise patients to relax and avoid moving when a blood pressure measurement is made.
 NIBP cuffs and hoses supplied with the Surveyor do NOT contain any Latex. If the patient develops an allergic
reactionorrashes, immediatelyremovethe cuff.
Invasive Pressure Warnings
 All invasive procedures involve risks to the patient. Use aseptic technique. Follow catheter manufacturer's
instructionsandestablishedhospitalguidelines.
 Ensure that no part of thepatientconnectionstouches anyelectricallyconductive material includingearth.
 Onlyuse invasive pressures transducers that canwithstand defibrillation as required byANSI/AAMI BP22
standard.
 Mechanical shock to the invasive blood pressure transducer maycause severe shifts in zero balance and
calibration, and cause erroneousreadings.
CO2 Warnings
 Always inspect the airwayadapter for a tight connection and proper operation before attaching it to the patient.
 Remove theairwaysamplingline fromthepatient’s airwaywhile nebulized medications arebeingdelivered.
 Route alltubingawayfromthe patient’s throatto avoid strangulation.
 Do not apply pressurized air to any outlet or tubing connected to the monitor. Pressure may destroy sensitive
elements.
 When monitoring an anesthetized patient in an operating room environment, it is recommended to connect the
CO2 exhaust port of the Surveyor to the hospital’s waste gas scavenging system so as to prevent exposure for
other patients and hospital personnel to the patient’s respiratory sample. Ensure that sampled gases are not
returned from the exhaust port to a breathing system such as a ventilator. Use standard clinical guidelines and/or
hospital procedures. Scavenge vacuum greater than 1mmHg mayresult in damage to the Surveyor.
 When using a sampling line for intubated patients with a closed suction system, do not place the airwayadapter
between the suction catheter and endotracheal tube. This is to ensure that the airway adapter does not interfere
withthe functioning ofthesuction catheter.
 Looseor damaged connectionsmaycompromiseventilation orcause an inaccuratemeasurement ofrespiratory
gases. Securely connect all components and check connections for leaks according to standard clinical
procedures.
 Do not cut or remove any part of the sample line. Cuttingthe sample line could lead to erroneous readings.
 If too much moisture enters thesampling line (i.e., fromambient humidityor breathing of unusuallyhumid air),
the message CO2 Purging Line will appear in the message area. If the sampling line cannot be cleared, the
message CO2 occluded line will appear in the message area. Replace the sampling line once the CO2 occluded
line messageappears.
Cardiac Output Warnings