Surveyor S12 and S19 Patient Monitor User Manual V3.1.0 July 2017

Copyright © 2018 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

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. V3.1.0 2017-07 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™, DuraY™, 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 Medical Ltd. 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 CO 2 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

TABLE OF CONTENTS 1.

GENERAL STATEMENTS ... 1 TECHNICAL SUPPORT AND SERVICE ...1

2.

NOTICES ... 2 MANUFACTURER’S RESPONSIBILITY ...2 RESPONSIBILITY OF THE CUSTOMER ...2 EQUIPMENT IDENTIFICATION ...2 COPYRIGHT AND TRADEMARK NOTICES ...2 OTHER IMPORTANT INFORMATION...2

3.

WARRANTY INFORMATION ... 3 YOUR MORTARA WARRANTY ...3

4.

USER SAFETY INFORMATION ... 5 SAFETY REGULATIONS...5 WARNINGS...5 Power Warnings ...6 Accessories, Cables, and External Connections Warnings ...7 Use with Electro Surgery Devices Warnings ...9 Installation and Mounting Warnings ...9 ECG Warnings ...10 ECG Calculated Heart Rate Warnings ...11 Warnings for Patients with Pacemakers ...11 Respiration Warnings ...12 SpO2 Warnings ...12 NIBP Warnings ...14 Invasive Pressure Warnings ...15 CO2 Warnings ...15 Cardiac Output Warnings ...15 CAUTIONS ...16 NOTES ...17

5.

EQUIPMENT SYMBOLS AND MARKINGS ... 19 SYMBOL DELINEATION ...19 NETWORK SYMBOL DELINEATION ...20

6.

GENERAL CARE ... 21 PRECAUTIONS ...21 INSPECTION ...21 CLEANING ...21 MAINTENANCE ...24 BATTERY REPLACEMENT ...26 Battery Life and Charge Time ...28 Battery Conditions ...28 DECOMMISSIONING AND DISPOSAL ...28 CALIBRATION ...28 CO2 Calibration ...29 Invasive Pressure Calibration ...29 NIBP Calibration ...29

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TABLE OF CONTENTS

7.

ELECTROMAGNETIC COMPATIBILITY (EMC) ... 30

8.

INTRODUCTION ... 34 GENERAL INFORMATION ...34 INDICATIONS FOR USE ...34 CONTRAINDICATIONS...34 SYSTEM OVERVIEW ...35 Front View - Figure 3 Surveyor Patient Monitor: Front View Example ...35 Left Side View - Figure 4 Surveyor Patient Monitor: Left Side Patient Cable Connector Ports ...35 Right Side View ...36 Back View...36

9.

INSTALLATION AND SETUP ... 38 UNPACKING AND CHECKING...38 INSTALLATION METHODS ...38 Rolling Stand ...39 Wall Mount ...39 POWER ON/OFF ...39 TO CONNECT FOR CENTRAL STATION COMMUNICATION...40 TO CONNECT FOR 3RD PARTY EMR SOFTWARE ...40

10.

MAIN SCREEN DISPLAY ... 42

OVERVIEW ...42 PARAMETER AREAS ...42 Waveform Parameter Area...42 Numeric Parameter Area ...43 QUICK-ACTION KEY AREA ...44 Alarm Silence Quick-Action Key ...44 All ECG/12-Lead ECG Quick-Action Key...44 NIBP Start/Stop Quick-Action Key ...45 Trends Quick-Action Key ...45 Standby Quick-Action Key ...45 Print Quick-Action Key ...45 Setup Quick-Action Key ...46 Home Quick-Action Key ...46 MESSAGE AREA...46 SYSTEM CLOCK AREA...47 DEMOGRAPHIC AND STATUS AREA ...47 Patient Information ...47 Patient Mode Icon...47 Network Status Icon...47 11.

PATIENT MANAGEMENT ... 48

OVERVIEW ...48 PATIENT INFORMATION DIALOGUE ...48 Patient Mode Specifics ...49 ADMIT ...50 STANDBY MODE ...50 Standby: Hibernation Mode ...50 Standby: Discharge Mode ...52

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TABLE OF CONTENTS

12.

REMOTE VIEW AND ALARM NOTIFICATION ... 53

12.1. 12.2. 12.2.1. 12.2.2. 12.3. 12.3.1. 12.3.2. 12.3.3. 12.3.4. 12.3.5. 12.4. 13.

REMOTE VIEW - OVERVIEW ...53 REMOTE VIEW CONFIGURATION AND DISPLAY ...54 NETWORK SETUP ...54 SETTING REMOTE VIEW OPTIONS ON THE S12/S19 MONITOR ...55 USING REMOTE VIEW ...56 REMOTE VIEW ALARM NOTIFICATIONS ...56 THE REMOTE VIEW NOTIFICATION INDICATOR ...57 OBSERVING AN ALARM NOTIFICATION USING REMOTE VIEW ...58 REMOTE VIEW WITHOUT PRESENCE OF AN ALARM NOTIFICATION ...59 SILENCED REMOTE ALARMS ...60 REMOTE VIEW AND ALARM NOTIFICATION TROUBLESHOOTING ...61

ALARM BEHAVIORS AND MANAGEMENT ... 62

GENERAL ALARM BEHAVIOR ...62 PHYSIOLOGICAL ALARMS ...62 Alarm Levels ...62 TECHNICAL ALARMS ...62 INFORMATIONAL ALERT MESSAGES ...62 ALARM CONFIGURATION DEFAULTS ...63 Factory Default Settings ...63 Departmental Default Settings ...63 ALARM NOTIFICATIONS...63 Visual Alarm Notifications ...63 Alarm Light Notifications ...64 Audio Alarm Notifications ...64 Audio Annunciation Type ...64 Alarm Silence ...64 Alarm Paused/Suspend ...65 Alarm Off Icon ...66 ALARM LATCHING ...66 ALARM DELAY...67 MULTIPLE ACTIVE ALARMS: HIERARCHY OF DISPLAY ...67 Different Alarm Priorities ...67 Same Alarm Priorities ...67 AUTOMATIC PRINT ON ALARM ...67 ADJUSTING ALARM LIMITS...68 Adjusting Non-ST Numeric Parameter Alarm Limits ...68 Adjusting ST Alarm Limits ...68 ADJUSTING ALARM LEVELS ...69 Lethal Arrhythmia Alarm Levels ...69 Non-Lethal Arrhythmia Alarm Levels ...69 Non-ST Numeric Parameter Alarm Levels ...69 ST Alarm Levels ...70 ALARM AUTO SET ...70 ALARM INTERFACES...71 Alarm Output/Nurse Call ...71 Surveyor Central Station ...71 14.

ECG MONITORING ... 72

OVERVIEW ...72

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TABLE OF CONTENTS

QUALITY ECG DATA ACQUISITION ...72 Skin Preparation ...73 Electrode Placement ...73 ELECTRODE LOCATIONS...74 Using a 3-Wire ECG Lead Set ...74 Using a 5-Wire ECG Lead Set ...74 Lead II Monitoring ...75 Modified Chest Lead (MCL) Monitoring ...75 Pacemaker Patients ...76 Using the AM12M for Continuous ECG Monitoring ...76 Using the AM12M for Diagnostic Resting 12-Lead ECG Acquisition ...77 CHECKING THE ECG SIGNAL...78 ECG WAVEFORM TILE ...79 ALL ECG/12-LEAD DISPLAY MODE ...79 RESTING 12-LEAD ECG INTERPRETATION ...80 15.

ECG/HEART RATE/PULSE RATE MONITORING ... 82

OVERVIEW ...82 HEART RATE/PULSE RATE TILE ...82 HR/PR ALARM BEHAVIORS ...82 HEART RATE/PULSE RATE SOURCING ...82 SETUP HR/PR DIALOGUE ...83 HR/PR Alarm Limits...83 Auto Set HR/PR Alarm Limits ...83 HR/PR Alarms On ...83 HR/PR Print on Alarm ...84 ECG Lead Set ...84 ECG 12-Lead Enabled ...84 ECG Top Channel Lead ...85 ECG Size ...85 HR/PR Source ...85 HR/PR Tone ...85 ECG Filter ...86 HR/ARR Detection and Confirmation Leads ...86 Analyze Pacers ...86 ST Enabled ...87 Min. QRS Amp ...87 16.

ECG ARRHYTHMIA MONITORING ... 88

OVERVIEW ...88 NOISE AND ARTIFACT ...88 ABERRANT BEATS ...89 ATRIAL RHYTHMS ...89 ARRHYTHMIA/ST ALGORITHM LEARNING ...89 Automatic Learn ...89 Manual Relearn ...89 ARRHYTHMIA ANALYSIS METHODOLOGY ...90 First Step: Beat Detection ...90 Second Step: Heart Rate Calculation ...90 Third Step: Beat Typing and Template Memory ...90 ECG Leads Used for Analysis ...91

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TABLE OF CONTENTS

ARRHYTHMIA DEFINITIONS ...91 Lethal Arrhythmias ...91 Non-Lethal Arrhythmia Classifications ...92 ARRHYTHMIA SETUP...93 ARRHYTHMIA SETTINGS ...94 17.

ECG ST MONITORING... 96

OVERVIEW ...96 ENABLE/DISABLE ST ANALYSIS ...97 ST TILE ...97 ST ALARM BEHAVIORS ...97 Physiological ST Alarms ...97 ST TILE ALARM BEHAVIORS ...98 ST ALARM DELAY ...98 SETUP ST DIALOGUE ...98 Arrhythmia and ST Algorithm Learning ...99 ST Alarm Levels ...99 ST Print on Alarm ...100 ST Alarm Limits ...100 Display Averages...100 ST Display ...101 ST Delay After J-Point ...101 Enable ST Leads ...102 18.

NON-INVASIVE BLOOD PRESSURE MONITORING ... 103

OVERVIEW ...103 BLOOD PRESSURE TECHNOLOGY ...104 NEONATE & PEDIATRIC PATIENT NIBP CONSIDERATIONS ...104 HYPERTENSIVE PATIENT CONSIDERATIONS ...104 NIBP MONITORING PROCEDURE ...105 NIBP TILE ...105 NIBP ALARM BEHAVIORS ...106 NIBP START/STOP QUICK-ACTION KEY ...106 SETUP NIBP DIALOGUE ...106 NIBP Alarm Limits ...106 Auto Set NIBP Alarm Limits ...107 NIBP Alarms On...107 NIBP Print on Alarm ...107 NIBP Interval ...108 NIBP Initial Inflation Pressure ...108 NIBP Format ...109 Show NIBP Trends ...109 CUFF OVERPRESSURE ...110 19.

SPO2 MONITORING ... 111

OVERVIEW ...111 Mortara SpO2 Technology...111 Nellcor OxiMax Technology ...111 SPO2 MONITORING PROCEDURE ...111 SPO2 DISPLAY ...112 Pleth Waveform Parameter Tile ...112

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TABLE OF CONTENTS

SpO2 Numeric Parameter Tile ...112 SPO2 ALARM BEHAVIORS ...112 SETUP SPO2 DIALOGUE ...112 SpO2 Alarm Limits ...113 Desaturation alarm ...113 SpO2 Auto Set Alarms...113 SpO2 Alarms On...113 SpO2 Print on Alarm ...114 SpO2 Alarm Pause ...114 HR/PR Tone ...114 SatSeconds (Nellcor only)...114 Response Mode (Nellcor only) ...115 SPO2 FUNCTIONAL TESTING...115 20.

TEMPERATURE MONITORING ... 117

OVERVIEW ...117 TEMPERATURE MONITORING PROCEDURE ...117 TEMPERATURE DISPLAY ...117 TEMPERATURE ALARM BEHAVIORS ...117 SETUP TEMPERATURE DIALOGUE ...117 Temperature Alarm Limits ...118 Temperature Alarms On ...118 Temperature Print on Alarm ...118 Temperature Display Mode ...119 21.

RESPIRATION MONITORING ... 120

OVERVIEW ...120 RESPIRATION ACQUISITION ...120 Respirations: ECG Thoracic Impedance ...120 Respirations: CO2 Measurement ...120 RESPIRATION ALARM BEHAVIORS...120 RESPIRATION DISPLAY...121 Respirations Waveform Parameter Tile ...121 Respirations Numeric Parameter Tile ...121 SETUP RESPIRATION (RR) DIALOGUE ...121 Respiration Alarm Limits ...122 Respiration Alarms On ...122 Respiration Print on Alarm...122 Respiration Enabled (Disabled) ...123 ’No Respiratory Effort’ alarm ...123 22.

CO2 MONITORING... 124

OVERVIEW ...124 PRINCIPLES OF OPERATION ...124 INTEGRATED PULMONARY INDEX (IPI) PARAMETER ...125 CO2 MONITORING PROCEDURE...125 CO2 DISPLAY ...126 CO2 Waveform Parameter Tile ...126 CO2 Numeric Parameter Tile ...126 CO2 ALARM BEHAVIORS ...126 SETUP CO2 DIALOGUE ...127

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TABLE OF CONTENTS

CO2 Alarm Limits ...127 IPI Low Alarm Limit ...127 CO2 Auto ...128 CO2 Alarms On ...128 CO2 Print on Alarm ...128 CO2 Waveform Size ...129 IPI Enabled/Disabled ...129 IPI Age Range (Pediatric Only) ...129 23.

INVASIVE PRESSURE MONITORING ... 130

OVERVIEW ...130 INVASIVE PRESSURE MONITORING PROCEDURE ...130 INVASIVE PRESSURE DISPLAY ...131 Invasive Pressure Waveform Parameter Tile ...131 Invasive Pressure Numeric Parameter Tile ...131 INVASIVE PRESSURE ALARM BEHAVIORS ...132 SETUP INVASIVE PRESSURE DIALOGUE ...132 Invasive Pressure Alarm Limits ...132 Auto Set Invasive Pressure Alarm Limits ...133 Invasive Pressure Alarms On ...133 Invasive Pressure Print on Alarm ...133 Invasive Pressure Label ...134 Invasive Pressure Format ...134 Invasive Pressure Waveform Size ...135 Invasive Pressure Zero Set ...135 Invasive Pressure Zero All ...136 MEASURING PAWP...136 Printing the PAWP Waveform ...138 OVERLAPPING INVASIVE PRESSURES ...138 24.

THERMODILUTION CARDIAC OUTPUT ... 140

OVERVIEW ...140 CO DISPLAY ...140 CO ALARM BEHAVIORS...141 SETUP CO DIALOGUE ...141 Computation Constant ...141 Injectate Probe Type ...142 Measure PAWP ...142 Begin CO Measurement ...143 Hemodynamic Calculations ...146 Height ...146 Weight ...146 25.

HEMODYNAMIC CALCULATIONS ... 147

OVERVIEW ...147 HEMODYNAMIC CALCULATION PARAMETERS ...147 HEMODYNAMIC CALCULATION DIALOGUE ...147 HD Calcs Input Parameters ...148 HD Calcs Output Parameters ...148 Resample ...149 Print ...149

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TABLE OF CONTENTS

26.

LIST TRENDS ... 150

OVERVIEW ...150 TRENDS DIALOGUE...150 Trends and Alarm Behaviors ...151 Page Up/Page Down Arrows ...151 Interval ...151 Clear Trends ...151 Print Trends...151 Close Trends ...152 27.

SETUP ... 153

OVERVIEW ...153 PATIENT INFORMATION...153 PARAMETERS ...153 WAVEFORMS ...154 RECORDER...155 ARRHYTHMIA ...157 ALARM SUSPEND ...158 ALARMS...159 AUDIO ...160 RESTORE DEPARTMENTAL DEFAULTS ...161 ADMINISTRATION ...161 Configuration ...161 Communications ...162 Connectivity ...162 Screen Cleaning...163 Administration Setup Alarms Dialogue ...163 Administration Setup System Dialogue ...165 Administration Setup Service Dialogue ...166 Administration Setup Factory Dialogue ...166 28.

PRODUCT SPECIFICATIONS ... 167

GENERAL SPECIFICATIONS ...167 ENVIRONMENTAL CONDITIONS ...167 POWER REQUIREMENTS & BATTERY ...168 DISPLAY SPECIFICATIONS ...168 RECORDER SPECIFICATIONS...168 MOUNTING SPECIFICATIONS ...169 TRENDING ...169 29.

PARAMETER SPECIFICATIONS ... 170

PATIENT POPULATIONS ...170 WAVEFORMS ...170 ECG ...171 ARRHYTHMIA ANALYSIS ...172 ST ANALYSIS ...172 NON-INVASIVE BLOOD PRESSURE (NIBP) ...172 PULSE OXIMETRY (SPO2) ...173 TEMPERATURE ...174 RESPIRATIONS: VIA ECG IMPEDANCE...174 CAPNOGRAPHY (CO2) ...174

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1. GENERAL STATEMENTS Technical Support and Service Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760

European Union Representative

Hospital Customers: Physician Practice: U.S. Distribution:

Mortara Instrument Europe s.r.l. Via Cimarosa, 103/105 40033 Casalecchio di Reno (Bologna) Italy

Mortara Instrument Germany Hofgartenstraße 16 72379 Hechingen Germany Tel.: +49 (0) 7471 98 41 14-0 Fax: +49 (0) 7471 98 41 14-90 E-Mail: info @ welchallyn.com

Tel: +39 051 2987811 Fax: +39 051 6133582 E-mail: clienti.mortarait @ welchallyn.com

Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected] 24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts

[email protected] [email protected] [email protected]

Mortara Instrument Netherlands “Amerika” Gebouw– 7e verdieping Hoogoorddreef 15 1101 BA Amsterdam Netherlands Tel.: 020 206 1360 E-mail: infonl @ welchallyn.com Mortara Instrument Australia Head Office Suite 4.01, 2-4 Lyonpark Road Macquarie Park, Sydney NSW 2113 Australia Tel: 1800 650 083 Fax: +61 2 9562 0982 Mortara Instrument UK Clinitron House, Excelsior Road Ashby de la Zouch Leicester LE65 1JG Tel: 0207 365 6780 Fax: 0207 365 9694

1

2. NOTICES Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance of the patient monitor, as indicated by the label, only if article 2 of 93/42/EEC directive is applied, in particular: WARNING: System installation and assembly operations, extensions, readjustments, modifications or repairs are carried out by personnel authorized by Mortara Instrument, Inc. only. 

The patient monitor is used in accordance with the instructions for use.



The patient monitor is correctly maintained according to the standards authorized by Mortara Instrument, Inc. using original spare parts.



The patient monitor is used with original accessories and supplies that are in compliance with the standard specifications described in this manual.



The electrical installation of the relevant room complies with the requirements of appropriate regulations.

Responsibility of the Customer The user of this 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 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.

2

3. WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Mortara, or if not otherwise noted, for a period of twelve (12) months from the date of shipment. Consumable, disposable or single use products such 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) Supplies, accessories and internal parts NOT approved by Mortara; c)

Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides;

d) Accident; e)

A disaster affecting the Product/s;

f)

Alterations and/or modifications to the Product/s not authorized by Mortara;

g) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions. THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence there from relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT,

3

WARRANTY INFORMATION

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.

4

4. USER SAFETY INFORMATION Warning:

Means there is the possibility of personal injury to you or others.

Caution:

Means there is the possibility of damage to the 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 

Surveyor is a medical patient monitor.



Surveyor with all accessories that have a physical or logical connection with it, forms part of a Medical Electrical System. Surveyor complies with various safety and performance regulations as mentioned in this manual (Applied Standards).

Warnings



This manual gives important information about the use and safety of this 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 patient monitor.



Users are expected to be licensed clinical professionals knowledgeable about medical procedures and 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’s diagnosis.



Before attempting to use this device for clinical applications, the operator must read and understand the contents of the user manual and other accompanying documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and bystanders, or damage to the patient monitor. Contact Mortara Technical Service for additional training options.



The patient monitor provides the possibility to monitor multiple functions, but is not intended to be connected to more than one patient.



Operation of the equipment beyond its specified ranges, or beyond normal physiological conditions of human subjects, may cause inaccurate results.



A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. Do not mount any part of the device closer than 25 cm from outlets of flammable gases, including oxygen.

5

USER SAFETY INFORMATION



For proper operation and the safety of users or patients and bystanders, equipment and accessories must be connected only as described in this manual.



Repairs and modification must be made by authorized and trained technical personnel. Unauthorized modifications and repairs will void the Surveyor warranty and may pose a danger to patients and users.



The Surveyor, 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 this manual.



The quality of the signal produced by the device may be adversely affected by the use of other medical equipment, including but not limited to electrosurgery and ultrasound machines. Do not use the system in the presence of imaging equipment such as magnetic resonance imaging (MRI) and tomography systems. Simultaneous operation may damage the device or lead to erroneous results.



Portable and mobile RF communications equipment may affect 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 to alarms.



A patient monitor is an addition to monitoring patient 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, whether Surveyor and/or other systems, are utilized for monitoring patients, use of different alarm presets on each system may pose a safety risk. Be careful in using different alarm conditions on different systems.



Always ensure that the Patient Mode (adult, pediatric, neonate) is set appropriately for the patient since different default parameters of the monitor’s operation may be used depending on mode.

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 the environment where it is used.



To ensure that electrical safety is maintained during operation from AC power, the Surveyor external power adapter must be plugged into a hospital-grade outlet.



Where the integrity of 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 supply to power other devices, because of the risk of additional leakage currents and of transformer overload.

6

USER SAFETY INFORMATION



The device is not operative if no image appears on the screen. If the device becomes inoperative during monitoring, a medium level type alarm sounds and the system resets automatically.



Regularly check all mains power cables for damage and proper connection. Do not use equipment with a damaged power cord.



The Surveyor contains a lithium ion battery. The following precautions should be taken regarding the battery: o

Do not immerse the device in water.

o

Do not heat or throw the device in fire.

o

Do not leave the in conditions over 60 ºC or in a heated car.

o

Do not crush, drop, or puncture the battery as this may result in overheating and possible fire.

o

Only use the approved Mortara battery pack with the Surveyor monitor.

o

Follow the 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 fully discharged several times to allow for optimal performance.



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 is powered on, remove the patient monitor from service and contact Mortara Technical Support.



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, including exhausting the battery supply, monitoring will cease until AC power supply has been restored or a fresh battery is installed, and the monitor’s power switch is recycled.



For continued operation, always connect the Surveyor to a wall outlet when a Low Battery alarm indication occurs. Failure to do this can lead to an interruption of monitoring.



Ensure the battery has 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 illuminate indicating that the patient monitor is connected to mains power and charging. The battery icon on the main display indicates when the battery is fully charged.

Accessories, Cables, and External 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 safety concerns.



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

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USER SAFETY INFORMATION

and accessories should bear the CE Mark. Only use parts and accessories supplied with the patient monitor and available through Mortara Instrument, Inc. 

Medical devices have been designed to have a higher degree of protection against electric shock than, for instance, information technology equipment because patients often are connected to multiple devices and also may be more prone to the adverse effect of electric currents than healthy persons. All equipment that is connected to the patient, can be touched by the patient, or can be touched by another person while that person touches the patient at the same time, should have the same level of protection against electric shock as medical equipment. The Surveyor patient monitor is a medical device that has been designed to be connected to other devices for the purpose of receiving and transmitting data. Certain measures must be taken to prevent the risk of excessive electric current flow through the operator or patient when connected: o

All electrical equipment that is not medical electrical equipment must be placed outside of the “patient environment,” defined by applicable safety standards to be at least 1.5 meters (5 feet) from the patient. Alternatively, non-medical equipment may be provided with additional protection such as an additional protective earth connection.

o

All medical electrical equipment that has a physical connection to the Surveyor or the patient, or is in the patient environment must comply with applicable safety standards for medical electrical devices.

o

All electrical equipment that is not medical electrical equipment and has a physical connection to the Surveyor must comply with applicable safety standards, such as IEC 60950 for information technology equipment. This includes information network equipment connected through the LAN connector.

o

Conductive (metal) parts that can be touched by the operator in normal use and that are connected to nonmedical equipment should not be brought into the patient environment. Examples are connectors for shielded Ethernet or USB cables.

o

If multiple devices are connected to each other or to the patient, device chassis and patient leakage currents may be increased, and should be measured for compliance with applicable standards for medical electrical systems.

o

Avoid the use of portable multiple socket outlets. If used and not compliant with medical electrical device standards, an additional protective earth connection is required.

o

To prevent electric shock due to unequal ground potentials that may exist between points of a distributed network system or fault conditions in external network connected equipment, network cable shielding (where used) must be connected to protective earth ground appropriate to the area where the device is used.

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Do not use excessive force on any of the connection cables and handle all accessories with care.

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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-term use and should be removed from the patient promptly following testing.

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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.

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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 is required to minimize harm to the patient.

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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.

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USER SAFETY INFORMATION

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Mortara-approved manufacturers of accessories provide separate user manuals (e.g., patient cables, electrodes, etc.). Read these manuals thoroughly and refer to them for specific functions. It is recommended to keep all manuals together.

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To maintain safety and effectiveness, reusable sensors and cables - such as ECG electrodes and SpO2 sensors must not be used beyond their expiration date or useful life.

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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, immediately remove the accessory and inform Mortara Technical Support.

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Check the date and integrity of the packing of all accessories that need to be sterilized before use.

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Do not attach unauthorized devices such as a mouse or keyboard to the USB port.

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Do not attach unauthorized patient cable for use with AM12M. Patient cable should provide locking mechanism to mating device.

Use with Electro Surgery Devices Warnings 

The Surveyor is approved for use in the presence of electrosurgical (ESU) equipment providing the following precautions are taken: o

To minimize the risk of patient burns, only use ESU equipment that monitors the impedance of the ESU return wires.

o

Users should be properly trained in the operation of the ESU equipment.

o

The AM12M 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 away from the ESU knife and return wires to prevent burns to measurement sites.

o

To prevent burns to the patient in the event of a defective neutral ECG electrode of the device, it is necessary to place ECG electrodes far from the neutral electrode, and as equidistant as possible from the blade-neutral axis of the surgical patient monitor.

o

When activating the ESU device, the ECG signals may be distorted or may disappear, and Lead Fail or Noise alarms might be present. The signal should return once the ESU activation stops.

o

When activating the ESU device, using the SpO2 parameter as the heart rate source rather than the ECG parameter to determine heart rate may be clinically preferred.

Installation and Mounting Warnings 

Place the Surveyor on a flat and leveled surface or mount it according to the manufacturer’s instructions. Use only mounting accessories indicated in this manual. Place the Surveyor in a well-ventilated place. Keep the Surveyor away from overly hot, cold or humid places, places directly under sunlight, or dusty surroundings.

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Ensure that the Surveyor is securely placed or mounted such that it does not tip or drop which may damage the monitor and/or create a hazard to patients and hospital personnel.

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Use only roll stands and wall-mount fixtures recommended for Surveyor in this manual. Other types have not been tested with the monitors and may not provide adequate safety against fall / tip-over.

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A VESA-standard adapter is available on the back of the Surveyor system for wall, swivel-arm or rolling-stand mounting. The user is responsible for correct installation of the system.

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USER SAFETY INFORMATION

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Do not mount the S12 on a rolling stand at a height exceeding 110 cm (43”).

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The S19 should NOT be mounted on a rolling stand.

ECG Warnings 

Excessive patient movement could interfere with the operation of the system.

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Proper patient preparation is important to proper application of ECG electrodes and operation of the patient monitor.

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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 blank. A lead fail alarm is generated on the patient monitor.

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The AM12M acquisition module automatically calibrates 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 may fail. 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.

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ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.

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Defibrillation protection is guaranteed when the original Mortara ECG patient cables are used.

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Use only ECG patient cables listed in Section ACCESSORIES with this monitor. Other cables have not be tested with the monitor and may not provide sufficient performance and/or defibrillation protection.

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Check ECG cables for cracks or breakage prior to use to ensure adequate defibrillation protection.

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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 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 opinion through diagnostic statements output on the ECG report.

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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 ECGs printed 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 the possibility of motion artifact.

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The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes need to be determined by a clinician.

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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 a diagnosis.

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For full diagnostic quality, the resting ECG should be printed on the Surveyor Central Station printer and not on the S12 or S19 strip chart recorder.

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