Surveyor S12 and S19 User Manual Rev F June 2020

© 2020 Welch Allyn This document contains confidential information that belongs to Welch Allyn, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Welch Allyn, Inc. Software V3.1.X Welch Allyn is a registered trademark of Welch Allyn, Inc. Surveyor™, AM12M™, and VERITAS™ are trademarks of Welch Allyn, Inc. Nellcor™, Covidien™, C-LOCK™, Sat Seconds™, OxiMax™, MAX™, Max-Fast™, Soft Care™, Oxiband™, Dura-Y™, Pedi Check™, 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), Micro stream®, Filter line® 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 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.

The information in this document is subject to change without notice.

PATENT/PATENTS hillrom.com/patents May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications.

Hillrom Technical Support For information about any Hillrom product, contact Hillrom Technical Support at 1.888.667.8272, [email protected]

9515-183-51-ENG Rev F Revision Date 2020-06

901138 PATIENT MONITOR

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA hillrom.com Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc.

and EU IMPORTER Welch Allyn Limited Navan Business Park, Dublin Road, Navan, Co. Meath C15 AW22 Ireland Authorized Australian Sponsor Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park NSW 2113 Phone 800 650 083

TABLE OF CONTENTS 1. NOTICES ..................................................................................................................................................... 6 MANUFACTURER’S RESPONSIBILITY ....................................................................................................................................6 RESPONSIBILITY OF THE CUSTOMER ....................................................................................................................................6 EQUIPMENT IDENTIFICATION.............................................................................................................................................6 COPYRIGHT AND TRADEMARK NOTICES...............................................................................................................................7 OTHER IMPORTANT INFORMATION.....................................................................................................................................7 NOTICE TO EU USERS AND/OR PATIENTS ............................................................................................................................7 2. WARRANTY INFORMATION ........................................................................................................................ 8 YOUR WELCH ALLYN WARRANTY.......................................................................................................................................8 3. USER SAFETY INFORMATION .....................................................................................................................10 CAUTIONS ...................................................................................................................................................................22 NOTES........................................................................................................................................................................23 4. EQUIPMENT SYMBOLS AND MARKINGS .....................................................................................................25 SYMBOL DELINEATION ...................................................................................................................................................25 NETWORK SYMBOL DELINEATION ....................................................................................................................................27 5. GENERAL CARE ..........................................................................................................................................28 PRECAUTIONS ..............................................................................................................................................................28 INSPECTION .................................................................................................................................................................28 CLEANING ...................................................................................................................................................................28 MAINTENANCE.............................................................................................................................................................31 BATTERY REPLACEMENT.................................................................................................................................................34 6. ELECTROMAGNETIC COMPATIBILITY (EMC) ................................................................................................38 REGULATORY RADIO COMPLIANCE ...................................................................................................................................42 EUROPEAN UNION........................................................................................................................................................44 7. INTRODUCTION .........................................................................................................................................45 GENERAL INFORMATION ................................................................................................................................................45 INTENDED USE (FUNCTIONAL PURPOSE) ...........................................................................................................................45 INDICATIONS FOR USE ...................................................................................................................................................45 PRODUCT DESCRIPTION .................................................................................................................................................46 SYSTEM OVERVIEW .......................................................................................................................................................47 8. INSTALLATION AND SETUP.........................................................................................................................50 UNPACKING AND CHECKING............................................................................................................................................50 INSTALLATION METHODS ...............................................................................................................................................50 POWER ON/OFF ..........................................................................................................................................................51 TO CONNECT FOR CENTRAL STATION COMMUNICATION.......................................................................................................52 TO CONNECT FOR 3RD PARTY EMR SOFTWARE ...................................................................................................................52 9. MAIN SCREEN DISPLAY ..............................................................................................................................54 OVERVIEW ..................................................................................................................................................................54 PARAMETER AREAS.......................................................................................................................................................54 QUICK-ACTION KEY AREA ..............................................................................................................................................56 MESSAGE AREA............................................................................................................................................................58 DEMOGRAPHIC AND STATUS AREA...................................................................................................................................59 1

TABLE OF CONTENTS 10. PATIENT MANAGEMENT ........................................................................................................................60 OVERVIEW ..................................................................................................................................................................60 PATIENT INFORMATION DIALOGUE...................................................................................................................................60 ADMIT........................................................................................................................................................................62 STANDBY MODE...........................................................................................................................................................62 11. REMOTE VIEW AND ALARM NOTIFICATION ............................................................................................65 REMOTE VIEW - OVERVIEW............................................................................................................................................65 REMOTE VIEW CONFIGURATION AND DISPLAY....................................................................................................................66 NETWORK SETUP..........................................................................................................................................................66 SETTING REMOTE VIEW OPTIONS ON THE S12/S19 MONITOR .............................................................................................67 USING REMOTE VIEW....................................................................................................................................................68 REMOTE VIEW ALARM NOTIFICATIONS .............................................................................................................................68 THE REMOTE VIEW NOTIFICATION INDICATOR....................................................................................................................69 OBSERVING AN ALARM NOTIFICATION USING REMOTE VIEW ................................................................................................70 REMOTE VIEW WITHOUT PRESENCE OF AN ALARM NOTIFICATION..........................................................................................71 SILENCED REMOTE ALARMS............................................................................................................................................72 REMOTE VIEW AND ALARM NOTIFICATION TROUBLESHOOTING.............................................................................................73 12. ALARM BEHAVIORS AND MANAGEMENT ...............................................................................................74 GENERAL ALARM BEHAVIOR ...........................................................................................................................................74 PHYSIOLOGICAL ALARMS................................................................................................................................................74 TECHNICAL ALARMS ......................................................................................................................................................74 INFORMATIONAL ALERT MESSAGES..................................................................................................................................74 ALARM NOTIFICATIONS..................................................................................................................................................75 ALARM LATCHING.........................................................................................................................................................78 ALARM DELAY..............................................................................................................................................................79 MULTIPLE ACTIVE ALARMS: HIERARCHY OF DISPLAY ...........................................................................................................79 AUTOMATIC PRINT ON ALARM ........................................................................................................................................79 ADJUSTING ALARM LIMITS .............................................................................................................................................80 ADJUSTING ALARM LEVELS .............................................................................................................................................81 ALARM AUTO SET.........................................................................................................................................................82 ALARM INTERFACES ......................................................................................................................................................83 13. ECG MONITORING .................................................................................................................................84 OVERVIEW ..................................................................................................................................................................84 QUALITY ECG DATA ACQUISITION ...................................................................................................................................84 ELECTRODE LOCATIONS..................................................................................................................................................86 CHECKING THE ECG SIGNAL ...........................................................................................................................................91 ECG WAVEFORM TILE...................................................................................................................................................92 ALL ECG/12-LEAD DISPLAY MODE .................................................................................................................................92 RESTING 12-LEAD ECG INTERPRETATION..........................................................................................................................93 14. ECG/HEART RATE/PULSE RATE MONITORING.........................................................................................95 OVERVIEW ..................................................................................................................................................................95 HEART RATE/PULSE RATE TILE ........................................................................................................................................95 HR/PR ALARM BEHAVIORS............................................................................................................................................95 HEART RATE/PULSE RATE SOURCING ...............................................................................................................................95 SETUP HR/PR DIALOGUE ..............................................................................................................................................96 15. ECG ARRHYTHMIA MONITORING .........................................................................................................101 2

TABLE OF CONTENTS OVERVIEW ................................................................................................................................................................101 NOISE AND ARTIFACT ..................................................................................................................................................101 ABERRANT BEATS .......................................................................................................................................................102 ATRIAL RHYTHMS .......................................................................................................................................................102 ARRHYTHMIA/ST ALGORITHM LEARNING ........................................................................................................................102 ARRHYTHMIA ANALYSIS METHODOLOGY .........................................................................................................................103 ARRHYTHMIA DEFINITIONS ...........................................................................................................................................104 ARRHYTHMIA SETUP....................................................................................................................................................107 ARRHYTHMIA SETTINGS ...............................................................................................................................................108 16. ECG ST MONITORING ...........................................................................................................................109 OVERVIEW ................................................................................................................................................................109 ENABLE/DISABLE ST ANALYSIS......................................................................................................................................110 ST TILE.....................................................................................................................................................................110 ST ALARM BEHAVIORS ................................................................................................................................................110 ST TILE ALARM BEHAVIORS ..........................................................................................................................................111 ST ALARM DELAY .......................................................................................................................................................111 17. NON-INVASIVE BLOOD PRESSURE MONITORING ..................................................................................116 OVERVIEW ................................................................................................................................................................116 BLOOD PRESSURE TECHNOLOGY ....................................................................................................................................117 NEONATE & PEDIATRIC PATIENT NIBP CONSIDERATIONS...................................................................................................117 HYPERTENSIVE PATIENT CONSIDERATIONS .......................................................................................................................117 NIBP MONITORING PROCEDURE...................................................................................................................................118 NIBP TILE.................................................................................................................................................................118 NIBP ALARM BEHAVIORS ............................................................................................................................................119 NIBP START/STOP QUICK-ACTION KEY ..........................................................................................................................119 SETUP NIBP DIALOGUE ...............................................................................................................................................119 CUFF OVERPRESSURE ..................................................................................................................................................123 18. SPO2 MONITORING .............................................................................................................................124 OVERVIEW ................................................................................................................................................................124 SPO2 MONITORING PROCEDURE ...................................................................................................................................124 SPO2 DISPLAY............................................................................................................................................................125 SPO2 ALARM BEHAVIORS.............................................................................................................................................125 SETUP SPO2 DIALOGUE ...............................................................................................................................................126 SPO2 FUNCTIONAL TESTING..........................................................................................................................................128 19. TEMPERATURE MONITORING ..............................................................................................................129 OVERVIEW ................................................................................................................................................................129 TEMPERATURE MONITORING PROCEDURE.......................................................................................................................129 TEMPERATURE DISPLAY ...............................................................................................................................................129 TEMPERATURE ALARM BEHAVIORS ................................................................................................................................129 SETUP TEMPERATURE DIALOGUE ...................................................................................................................................129 20. RESPIRATION MONITORING.................................................................................................................132 OVERVIEW ................................................................................................................................................................132 RESPIRATION ACQUISITION...........................................................................................................................................132 RESPIRATION ALARM BEHAVIORS...................................................................................................................................132 RESPIRATION DISPLAY..................................................................................................................................................133 SETUP RESPIRATION (RR) DIALOGUE..............................................................................................................................133 3

TABLE OF CONTENTS 21. CO2 MONITORING ...............................................................................................................................136 OVERVIEW ................................................................................................................................................................136 PRINCIPLES OF OPERATION ...........................................................................................................................................136 INTEGRATED PULMONARY INDEX (IPI) PARAMETER...........................................................................................................137 CO2 MONITORING PROCEDURE.....................................................................................................................................138 CO2 DISPLAY .............................................................................................................................................................138 CO2 ALARM BEHAVIORS ..............................................................................................................................................139 SETUP CO2 DIALOGUE.................................................................................................................................................139 22. INVASIVE PRESSURE MONITORING ......................................................................................................143 OVERVIEW ................................................................................................................................................................143 INVASIVE PRESSURE MONITORING PROCEDURE ................................................................................................................143 INVASIVE PRESSURE DISPLAY.........................................................................................................................................144 INVASIVE PRESSURE ALARM BEHAVIORS..........................................................................................................................145 SETUP INVASIVE PRESSURE DIALOGUE ............................................................................................................................145 MEASURING PAWP ...................................................................................................................................................149 OVERLAPPING INVASIVE PRESSURES ...............................................................................................................................152 23. THERMODILUTION CARDIAC OUTPUT ..................................................................................................153 OVERVIEW ................................................................................................................................................................153 CO DISPLAY ..............................................................................................................................................................153 CO ALARM BEHAVIORS ...............................................................................................................................................154 SETUP CO DIALOGUE ..................................................................................................................................................154 24. HEMODYNAMIC CALCULATIONS ..........................................................................................................160 OVERVIEW ................................................................................................................................................................160 HEMODYNAMIC CALCULATION PARAMETERS ...................................................................................................................160 HEMODYNAMIC CALCULATION DIALOGUE .......................................................................................................................160 25. LIST TRENDS.........................................................................................................................................163 OVERVIEW ................................................................................................................................................................163 TRENDS DIALOGUE .....................................................................................................................................................163 26. SETUP ..................................................................................................................................................166 OVERVIEW ................................................................................................................................................................166 PATIENT INFORMATION ...............................................................................................................................................166 PARAMETERS .............................................................................................................................................................166 WAVEFORMS .............................................................................................................................. ...............................167 RECORDER.................................................................................................................................................................169 ARRHYTHMIA .............................................................................................................................. ...............................170 ALARM SUSPEND........................................................................................................................................................171 ALARMS....................................................................................................................................................................172 AUDIO......................................................................................................................................................................173 RESTORE DEPARTMENTAL DEFAULTS ..............................................................................................................................174 ADMINISTRATION .......................................................................................................................................................174 27. PRODUCT SPECIFICATIONS ...................................................................................................................180 GENERAL SPECIFICATIONS ............................................................................................................................................180 ENVIRONMENTAL CONDITIONS......................................................................................................................................180 POWER REQUIREMENTS & BATTERY...............................................................................................................................181 DISPLAY SPECIFICATIONS ..............................................................................................................................................181 4

TABLE OF CONTENTS RECORDER SPECIFICATIONS...........................................................................................................................................182 MOUNTING SPECIFICATIONS .........................................................................................................................................182 TRENDING .................................................................................................................................................................182 28. PARAMETER SPECIFICATIONS...............................................................................................................183 PATIENT POPULATIONS ................................................................................................................................................183 WAVEFORMS .............................................................................................................................. ...............................183 ECG ........................................................................................................................................................................184 ARRHYTHMIA ANALYSIS ...............................................................................................................................................185 ST ANALYSIS..............................................................................................................................................................185 NON-INVASIVE BLOOD PRESSURE (NIBP) .......................................................................................................................186 PULSE OXIMETRY (SPO2) .............................................................................................................................................187 TEMPERATURE ...........................................................................................................................................................187 RESPIRATIONS: VIA ECG IMPEDANCE ............................................................................................................................188 CAPNOGRAPHY (CO2) .................................................................................................................................................188 INVASIVE PRESSURES ...................................................................................................................................................189 CARDIAC OUTPUT.......................................................................................................................................................190 29. PARAMETER ALARM LIMIT RANGES .....................................................................................................191 ADULT PATIENT MODE ................................................................................................................................................191 NEONATE PATIENT MODE ............................................................................................................................................192 PEDIATRIC PATIENT MODE ...........................................................................................................................................194 30. ALARM SPECIFICATIONS.......................................................................................................................196 GENERAL ALARMS ......................................................................................................................................................196 ECG AND HR MESSAGES .............................................................................................................................................196 NON-INVASIVE BLOOD PRESSURE (NIBP) MESSAGES........................................................................................................198 PULSE OXIMETRY (SPO2) MESSAGES..............................................................................................................................199 TEMPERATURE MESSAGES............................................................................................................................................200 RESPIRATION MESSAGES..............................................................................................................................................201 CAPNOGRAPHY (CO2) MESSAGES ..................................................................................................................................202 INVASIVE PRESSURE MESSAGES .....................................................................................................................................203 CARDIAC OUTPUT MESSAGES .......................................................................................................................................204 NETWORK MESSAGES..................................................................................................................................................205 31. TROUBLESHOOTING.............................................................................................................................206 POWER AND BATTERY..................................................................................................................................................206 DISPLAY AND TOUCH SCREEN........................................................................................................................................206 ECG, ARRHYTHMIA, AND ST.........................................................................................................................................207 NON-INVASIVE BLOOD PRESSURE (NIBP) .......................................................................................................................208 PULSE OXIMETRY (SPO2) .............................................................................................................................................208 TEMPERATURE ...........................................................................................................................................................209 RESPIRATIONS: VIA ECG THORACIC IMPEDANCE ..............................................................................................................209 CAPNOGRAPHY (CO2) .................................................................................................................................................209 INVASIVE PRESSURES ...................................................................................................................................................210 CARDIAC OUTPUT.......................................................................................................................................................210 32. ACCESSORIES .......................................................................................................................................211 5

1. NOTICES Manufacturer’s Responsibility Welch Allyn, Inc. is responsible for the effects on safety and performance of the patient monitor, as indicated by the label WARNING: System installation and assembly operations, extensions, readjustments, modifications or repairs are carried out by personnel authorized by Welch Allyn, 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 Welch Allyn, 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 Welch Allyn, 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 Welch Allyn, 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. The device product label is applied showing the unique identification numbers along with other important information printed on the label. The serial number format is as follows: YYYWWSSSSSSS YYY = First Y is always 1 followed by two-digit Year of manufacture WW = Week of manufacture SSSSSSS = Sequence number of manufacture The patient monitor product label and UDI label (when applicable) are applied to the back of the monitor. The Lithium Ion Battery label is applied to the battery compartment. AM12M Module Identification The wired Acquisition Module is identified with a product label on the back of the device and will have its own unique serial number and UDI label applied. 6

NOTICES 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 Welch Allyn, Inc. Other Important Information The information in this document is subject to change without notice. Welch Allyn, 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. Welch Allyn, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Welch Allyn, Inc. makes no commitment to update or to keep current the information contained in this document. Notice to EU Users and/or Patients Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. 7

2. WARRANTY INFORMATION Your Welch Allyn Warranty WELCH ALLYN, INC. (hereafter referred to as “Welch Allyn”) warrants that components within Welch Allyn 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 Welch Allyn, 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 Welch Allyn; 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 Welch Allyn; g) Other events outside of Welch Allyn’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 WELCH ALLYN TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Welch Allyn of any alleged defects promptly after discovery thereof within the warranty period. Welch Allyn’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 Welch Allyn’s principal place or any other place as specifically designated by Welch Allyn or an authorized distributor or representative of Welch Allyn, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Welch Allyn is limited and that Welch Allyn does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Welch Allyn 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 Welch Allyn should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Welch Allyn shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. 8

WARRANTY INFORMATION EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN 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 WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL WELCH ALLYN 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. 9

3. USER SAFETY INFORMATION

WARNING: Caution: Note:

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

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 Welch Allyn 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.

10

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 Welch Allyn-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. 11

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 Welch Allyn 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. o Do not use batteries that have been physically damaged. • 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 Welch Allyn 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 or when the Surveyor is not in mobile use. 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 Welch Allyn-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. 12

USER SAFETY INFORMATION • It is the user’s responsibility to use only approved supplies, accessories and internal parts available through Welch Allyn, 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 available through Welch Allyn, 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. • Do not use excessive force on any of 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-term use and should be removed from the patient promptly following testing. • 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. 13

USER SAFETY INFORMATION • 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. • 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. • Welch Allyn-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. • 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. • 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 Welch Allyn Technical Support. • Check the date and integrity of 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 mating device. • Carefully route cables to reduce any possibility of patient entanglement or strangulation. 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. 14

USER SAFETY INFORMATION 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. • 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. • 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. • 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. • Do not mount the S12 on a rolling stand at a height exceeding 110 cm (43”). • The S19 should NOT be mounted on a rolling stand. ECG Warnings • Excessive patient movement could interfere with the operation of the 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 or printed, the respective lead(s) will print out as blank. A lead fail alarm is generated on the patient monitor. • 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. • ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation. • Defibrillation protection is guaranteed when the original Welch Allyn ECG patient cables are used. • 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. • Check ECG cables for cracks or breakage prior to use to ensure adequate defibrillation protection. Do not use damaged, cracked, or broken ECG cables. • 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 Welch Allyn’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. 15

USER SAFETY INFORMATION • 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. • 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. • 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. ECG Calculated Heart Rate Warnings • Heart rate indication is usually not affected by pacemakers with direct cardiac application, ventricular or supraventricular arrhythmias or irregular heart rates; however, in some conditions a 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 pacemaker spike. • 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 IEC 60601-2-27. • Tall and peaked T-waves may affect QRS detection resulting in doubled heart rates. Surveyor rejects tall TWaves less than or equal to 230% of a 1 mV QRS in diagnostic mode, and 70% of a 1 mV QRS in monitoring mode, as well as a Q-T interval of 350 ms measured for both diagnostic and monitoring modes according to IEC 60601-2-27. • The heart rate meter correctly detects all beats of the alternating beat type waveforms considered in IEC 606012-27 Figure 201.101 patterns A1-A4 if the QRS amplitudes exceed the minimum detection threshold set by the user. • Time to tachycardia alarm, as measured according to IEC 60601-2-27 Figure 201.101 patterns B1-B2 is less than 9 seconds. • Heart rate indication is not reliable during episodes of ventricular fibrillation. 16

USER SAFETY INFORMATION

• The summarized performance of the QRS recognition and classification algorithm on standard databases, as defined by ANSI/AAMI EC 57, is as follows:

Performance Measures QRS Detection Sensitivity % QRS Detection Positive Predictivity % PVC Detection Sensitivity % PVC Detection Positive Predictivity % PVC Detection False Positive Rate % Performance Measures QRS Detection Sensitivity % QRS Detection Positive Predictivity % PVC Detection Sensitivity % PVC Detection Positive Predictivity % PVC Detection False Positive Rate %

MIT Database Welch Allyn 99.92 99.87 95.17 97.04 0.220 AHA Database Welch Allyn 99.79 99.91 93.15 98.40 0.154

• Because of noise, artifact and the many different physiological manifestations of the ECG signal, it is inevitable that some beats are not detected or correctly classified by the system. The user is advised not to rely completely on automatic alarm systems for the monitoring of critical patients.

17

USER SAFETY INFORMATION Warnings for Patients with Pacemakers • Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. • 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 slew rate over 1.4 V/s, as measured according to IEC 60601-2-27. • 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 IEC 60601-2-27:2011. • 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 cardiac arrest. • Other than the influence on beat detection as stated above, there is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the system. Respiration Warnings • When using an ECG electrode to 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 components can result in degraded performance and/or device malfunction. • Use pulse oximetry sensors specified for the correct patient mode and for the correct application position. • Pulse oximetry sensors must be checked a minimum of every 4 hours and moved to a new site as necessary. Reposition the sensor at least once every 24 hours to allow the patient’s skin to breathe. • Tissue damage or inaccurate measurements may be caused by incorrect SpO2 sensor application or use, such as 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 to use. • 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 xenon light sources, ambient photodynamic therapy (e.g., Bilirubin lamps), fluorescent lights, infrared heating lamps, direct sunlight. Shield the sensor area as necessary. • SpO2 measurement may be adversely affected by dyes (e.g., methylene blue, indocyanine green, indigo, carmine, fluorescein) introduced into the bloodstream • That factors that may cause inaccurate readings and alarms, decreased perfusion, and or low signal strength include: 18

USER SAFETY INFORMATION Interfering substances: o Carboxyhemoglobin may erroneously increase SpO2 reading. o Methemoglobin (MetHb) usually represents less than 1% of the total Hgb, but in the case of methemoglobinemia that can be congenital or induced by some IV dyes, antibiotics (such as sulphas,) inhaled gases etc. this level increases sharply and thus can confound the SpO2 reading. o Intravascular dyes (such as indocyanine green, methylene blue, etc.). Physiological conditions: o Cardiac arrest o Hypotension o Shock o Severe vasoconstriction o Severe anemia o Hypothermia o Venous pulsations o Ventricular septal defects (VSDs) Sensor placement: o Incorrect sensor placement o Poor sensor fit • Any condition that restricts blood flow such as the use of a blood pressure cuff or supplemental tape, or extremes in systemic vascular resistance may cause inability to determine accurate SpO2 readings. • Certain conditions such as physical movement (patient and imposed motion); diagnostic testing; low perfusion; electromagnetic interference; electrosurgical patient monitors; dysfunctional hemoglobin; and inappropriate positioning of the pulse oximeter sensor may result in pulse oximetry readings that are unreliable. • SpO2 signal inadequacy is indicated by error messages or alarms generated at the Surveyor 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, or sensor 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 patient deoxygenation is indicated, blood samples should be analyzed by a laboratory COoximeter 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 or modules. Discard a damaged sensor or cable immediately. • The performance of the pulse oximetry may be compromised by excessive motion including tremors or shivering. 19

USER SAFETY INFORMATION • Nail polish and/or artificial fingernails can affect the accuracy of pulse oximetry and 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 or substitute for ECG-based arrhythmia analysis. • In certain situations such as low perfusion 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 any therapy or intervention. • Always monitor ECG for arrhythmia detection purposes. HR calculated from pulsatile SpO2 waveform may differ significantly from ECG HR measured values. NIBP Warnings • Use only approved blood pressure (BP) cuffs specifically intended for use 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’s arm or not. • When used with neonate patients, ensure that the patient mode is set to neonate such that the cuff inflation is appropriately set. Only models configured with Nellcor SpO2 support the Neonatal patient type. • To provide safe operation, the Surveyor S12 and S19 patient monitors must be manually set by the user to the operating mode appropriate for the patient: “neonatal,” “pediatric,” or “adult.” • 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 of blood 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 or errors. • The pressure measurement might be influenced by patient position, physical conditions, and other factors. • 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 dermatological disease, subcutaneous laceration, or other integumentary compromise as there may exist 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 may be 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 of disease or infection, reusable blood pressure cuffs should be cleaned after each patient use. Disposable blood pressure cuffs should not be used with multiple patients. 20

USER SAFETY INFORMATION • 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 different limbs. • 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 reaction or rashes, immediately remove the cuff. Invasive Pressure Warnings • All invasive procedures involve risks to the patient. Use aseptic technique. Follow catheter manufacturer's instructions and established hospital guidelines. • Ensure that no part of the patient connections touches any electrically conductive material including earth. • Only use invasive pressures transducers that can withstand defibrillation as required by ANSI/AAMI BP22 standard. • Mechanical shock to the invasive blood pressure transducer may cause severe shifts in zero balance and calibration, and cause erroneous readings. CO2 Warnings • Always inspect the airway adapter for a tight connection and proper operation before attaching it to the patient. • Remove the airway sampling line from the patient’s airway while nebulized medications are being delivered. • Route all tubing away from the patient’s throat to 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 may result in damage to the Surveyor. • When using a sampling line for intubated patients with a closed suction system, do not place the airway adapter between the suction catheter and endotracheal tube. This is to ensure that the airway adapter does not interfere with the functioning of the suction catheter. • Loose or damaged connections may compromise ventilation or cause an inaccurate measurement of respiratory 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. Cutting the sample line could lead to erroneous readings. • If too much moisture enters the sampling line (i.e., from ambient humidity or breathing of unusually humid air), the message Clearing FilterLine will appear in the message area. If the sampling line cannot be cleared, the 21

USER SAFETY INFORMATION message FilterLine Blockage will appear in the message area. Replace the sampling line once the FilterLine Blockage message appears. Cardiac Output Warnings • Refer to the catheter package insert provided with each PA catheter for the appropriate computation constant, specific instructions on catheter placement and use, warnings, cautions, and specifications. • Inaccurate Cardiac Output measurements may be caused by: o Incorrect placement or position of the catheter. o Excessive variation in pulmonary artery blood temperature, perhaps caused by bolus drug administration. o Anatomical abnormalities, (for example, cardiac shunts). o Excessive patient movement. o Repeated intermittent flushes of cold fluid through the fluid lumens of the catheter. o Electrocautery or electrosurgical device interference. o Rapid changes in cardiac output. o Using an incorrect computation constant. • Cardiac Output is not available in neonate patient mode. Cautions • Cleaning must be performed with the system turned off. Let all parts dry well before turning the power back on. • Prevent liquids from penetrating the system, components, and transmitters. Do not spray the system with liquid cleaning agents. If liquids have penetrated the system, open by authorized personnel for inspection and let dry completely. Use only indoors. • Do not attempt to clean the patient monitor or patient cables by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting shock, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to the patient monitor. • No user-serviceable parts inside. Screw removal by authorized service personnel only. Damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by authorized service personnel prior to continued use. • The rechargeable internal battery is a sealed lithium ion type. If the battery appears to become defective, refer to Welch Allyn Technical Support. • Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. When not in use, patient cables can be stored. Keep patient cables should be stored off of the floor away from bedrails and wheels to avoid cable damage. Roll the patient cables into a loose loop prior to hanging for storage. 22

USER SAFETY INFORMATION • When necessary, dispose of the patient monitor, its components and accessories (e.g., batteries, cables, electrodes), and/or packing materials in accordance with local regulations. • Do not connect the patient monitor to any unauthorized patient monitors or use any third-party accessories. This may cause inaccurate measurements or harm the patient. Installation and connection to data networks must be performed by properly trained personnel, authorized by Welch Allyn. • Check that all operating and environment conditions such as ambient temperature meet the specifications of the Surveyor. Do not use the Surveyor outside the specified operating and environmental conditions. • Do not exert excessive pressure on the touch panel LCD. Excessive pressure may permanently damage the display. • During MRI scanning, the module must be placed outside the MRI suite. When the module is used outside the MRI suite, EtCO2 monitoring can be implemented using the FilterLine XL. • Use of a CO2 sampling line with H in its name (indicating that it is for use in humidified environments) during MRI scanning may cause interference. The use of non H sampling lines is advised. • Microstream® EtCO2 sampling lines are designed for single patient use, and are not to be reprocessed. Do not attempt to clean, disinfect, sterilize or flush any part of the sampling line as this can cause damage to the monitor. • Dispose of sampling lines according to standard operating procedures or local regulations for the disposal of contaminated medical waste. • Before use, carefully read the Microstream® EtCO2 sampling lines Directions for Use. • Only use Microstream® EtCO2 sampling lines to ensure the monitor functions properly. Notes • The Surveyor’s NIBP parameter is indicated for use with pregnant patients, including those with pre-eclamptic or eclamptic conditions. • The Surveyor’s NIBP parameter includes systolic, diastolic and mean arterial pressure (MAP). This MAP is determined based on the highest point of the oscillometric curve during the cuff deflation. There may be differences between the measured MAP via the oscillometric method and the calculated MAP based on the sometimes used “estimated method” of MAP = Diastolic Blood Pressure + (Pulse Pressure)/3. • Patient movements may generate excessive noise that may affect the quality of signals and derived parameters and waveforms. • Proper patient preparation is important to proper application of sensors and electrodes to ensure the correct operation of the patient monitor. • There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used simultaneously with the patient monitor; however, disturbance to the signal may occur. • If an ECG electrode is not connected properly to the patient, or one or more of the patient cable lead wires are damaged, the display will indicate a lead fault for the lead(s) where the condition is present and if the signal is being printed, the respective lead(s) will print out as blank. 23

USER SAFETY INFORMATION • This patient monitor is intended to be used in a hospital or doctor’s office setting, and should be used and stored according to the environmental conditions specified. • During nebulization or suction for intubated patients, in order to avoid moisture buildup and sampling line occlusion, remove the sampling line luer connector from the monitor. • Replace the sampling line according to hospital protocol or when a blockage is indicated by the device. Excessive patient secretions or a build-up of liquids in the airway tubing may occlude the sampling line, requiring more frequent replacement. • When the caution message “Blockage” appears on the screen, indicating that the FilterLine which is attached to the monitor is blocked, the monitor’s CO2 pump will stop pumping the patient’s breath into the monitor for testing. Follow the instructions that appear in the Troubleshooting section of this manual: First disconnect and reconnect the FilterLine. If the message still appears, disconnect and replace the FilterLine. Once a working FilterLine is attached to the monitor, the pump will automatically resume operation. • Following connection of the CO2 sampling line to the monitor and patient, check that CO2 values appear on the monitor display. • The device is ETL listed: ETL-Listed device in the USA and Canada. • Upon request, Welch Allyn can supply a Service Manual that includes additional calibration and test instructions as well as list of spare parts and accessories that must be used with the Surveyor patient monitors. The S12 recorder may not properly print all characters in all languages. In particular, special characters in certain languages such as accented characters in Polish, Hungarian and Croatian, may not be printed correctly on the recorder and instead be displayed with a “?”. 24

4. EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation

IPX1

WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. In addition, when used on a patient applied part, this symbol indicates defibrillation protection is in the cables. Warning symbols will appear with a grey background in a black and white document.

CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data.

Indicates compliance to applicable European Union directives Indicates device has been tested for safety from vertically dripping water; specifically, it indicates DRIP PROOF, a higher than ordinary level of protection from drips, leaks, and spills Tested for safety by the Intertek according to applicable U.S. and Canadian standards and requirements

Do not dispose as unsorted municipal waste. Requires separate handling for waste disposal according to local requirements as per 2012/19/EU. Defibrillator-proof type CF applied part External power AC/DC power supply; use only Welch Allyn Power Supply; REF 4101-012

Power On/Off switch

Follow instructions/directions for use (DFU) -mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Hillrom for delivery within 7 calendar days.

Local Area Network interface

External alarm interface

ARTWORK IOIOI RIGHT SIDE VIEW Ink Color : Dar k Blue, Pantone 295C Housing, Rear, Sur veyor S12 w-Reocder Pr inted 451-6600-P Rev. 3 Scale 1/1 Zoe Medical, Inc., 460 Boston Street, Topsfield, MA 01983

Interface to external devices – Reserved for future use

Connector for 12-lead ECG parameter using Welch Allyn AM12M

Connector for oxygen saturation parameter

Connector for 3/5 lead ECG parameter

Connector for non-invasive blood pressure parameter

CO

Connector for cardiac output parameter

Connector for invasive pressure 1 & 2 parameters

Connector for invasive pressure 3 & 4 parameters

25

EQUIPMENT SYMBOLS AND MARKINGS

Connector for temperature 1 parameter

Connector for temperature 2 parameter

Connector for CO2 parameter Protective earth

ARTWORK Rear view Ink Color: Dark Blue, Pantone 295C Housing, Rear, Surveyor S12 w-Reocder Printed 451-6600-P Rev. 3 Scale 1/1 Zoe Medical, Inc., 460 Boston Street, Topsfield, MA 01983

Connector for CO2 parameter exhaust port

Contains non-spillable battery

This end up

Keep away from heat

Fragile, handle with care

Keep dry

Humidity limitation

Atmospheric pressure limitation

Storage temperature range Lot number Medical Device Recorder Number Serial Number Global Trade Item Number Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM).

10 rolls of recorder paper per case Non-ionizing electromagnetic radiation Model Identifier Authorized representative in the European Community Manufacturer Alternative Current Prescription only or "For Use by or on the order of a licensed medical professional"

26

Network Symbol Delineation Network Ethernet Connected Network Ethernet Connected No connection to Surveyor Central Network Ethernet Not Connected

EQUIPMENT SYMBOLS AND MARKINGS Network WiFi Not Connected Network WiFi Connected No connection to Surveyor Central Network WiFi Connected – Minimal Signal Strength Network WiFi Connected – Signal Strength Indicator

27

5. GENERAL CARE Precautions • Power off the patient monitor before inspecting or cleaning. • Protect the patient monitor from liquids. • Never immerse the patient monitor in water. • Do not drop the patient monitor or subject to shock and/or vibration. • Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents that may damage equipment surfaces. Inspection Inspect your equipment daily prior to clinical operation. • Verify that all cords and connectors are securely seated. • Check the case and chassis for any visible damage. • Inspect cables, cords, and connectors for any visible damage. • Inspect keys and controls for proper function and appearance. • Check for neat and well-balanced screen images. • Inspect patient accessories such as cuffs, sensors, and wires for any visual damage. • Ensure that auditory and visual alarms are available and working appropriately. WARNING: Do not use the equipment and contact an authorized service representative for servicing if there are visible damages or concerns about integrity of the system. Cleaning The following section provides information on proper cleaning directions for the Surveyor patient monitor and patient accessories. Accessories should be cleaned before they are applied to a new patient. The patient monitor should be cleaned as per facility standard of care. Before cleaning, please refer to the cautions listed below. 28

GENERAL CARE WARNING: Clean and disinfect the monitor and its accessories in accordance with these instructions and your facility’s standards of care for the prevention of nosocomial infection. CAUTION: Always disconnect the Surveyor patient monitor from AC (wall) mains power before cleaning. CAUTION: Do not use harsh chemicals for cleaning. Do not use disinfectants that contain phenol as they can spot plastics. Do not steam autoclave, gas sterilize, irradiate, subject to intense vacuum, or immerse in water or cleaning solution. Be careful to avoid getting cleaning liquids into connectors or the patient monitor. If this occurs, allow the patient monitor to dry in warm air for 2 hours, then check to make sure all monitoring functions are working properly. CAUTION: Take particular care when cleaning the NIBP cuff, NIBP hose, and NIBP connector on the Surveyor patient monitor to prevent fluid from entering the connectors or cuff. Fluid in the NIBP system may affect blood pressure determination accuracy and damage the monitor. CAUTION: Keep the patient accessories off of the floor. Accessories that fall on the floor should be inspected for defects, contamination, proper functionality, and cleaned or discarded according to the approved recommendations. CAUTION: The user has the responsibility to validate any deviations from the recommended method of cleaning and disinfection. 29

Touch screen Display ECG Cables TEMP Cable SpO2 Cable NIBP Hose External Power Supply Power Cord

GENERAL CARE Approved Cleaning Agents • Clean the touch screen with a soft cloth moistened with either a solution of 70% isopropyl alcohol in distilled water or soapy water. Do not spray cleaner directly onto the touch screen. Spray the cleaner onto a lint-free cloth and then wipe the monitor. To clean the touch screen display, 1. Select the Settings sidebar button. 2. Select the Administrative menu. 3. Select the Screen Cleaning mode. This action disables the monitor’s touch screen for 15 seconds for cleaning purposes. After the 15 seconds expires, the touch screen controls are reactivated. Approved Cleaning Agents • Enzymatic detergent such as ENZOL (US) or CIDEZYME (outside the US) • Distilled water • Disinfectant solution (such as CIDEX OPA, or a 10% solution of household bleach (5.25% sodium hypochlorite) in distilled water) • Soft, lint-free cloths and/or soft-bristled brushes • Protective gloves and eyewear Procedure 1. Disconnect the patient monitor from the wall outlet. 2. Put on gloves and protective eyewear. 3. Prepare the enzymatic detergent according to the manufacturer's instructions, and also the disinfectant solution, in separate containers. 4. Apply detergent to product using a soft, lint-free cloth. If material is dried on, allow to sit for 1 minute. Do not immerse cable ends or lead wires in liquid as it can cause corrosion. 5. Wipe smooth surfaces with the cloth. 6. Use a soft-bristle brush on visibly soiled areas and irregular surfaces. 7. Remove detergent from product using cloth dampened in distilled water. 8. Repeat as necessary. 9. Apply disinfectant solution on affected area using a soft cloth. Allow product to sit for 5 minutes. 10. Wipe excess solution and clean product again with cloth dampened in distilled water. 11. Allow 2 hours for drying.

30

GENERAL CARE

Reusable NIBP Cuffs SpO2 Reusable Sensor Disposable: SpO2 Sensors Temperature Probes CO2 Lines

Approved Cleaning Agents • Mild detergent and water • Non-chlorine bleach Procedure 1. Prior to washing, remove any internal cuff bladders and engage the Velcro hook and loop fasteners to prevent lint from collecting in the hooks. 2. For general cleaning of cuffs, use a soft, lint-free cloth lightly moistened with a mild soap and water solution. Be careful not to get liquid inside the tubes. Allow to air dry. 3. For excessive perspiration marks or odor, the exterior of the cuff can be hand-washed under running water with a mild detergent. Do not allow water to enter the cuff. Allow to air dry. 4. If required, the use of non-chlorine bleach is acceptable. Using chlorine bleach solutions will shorten the service life of the cuff. 5. Disinfect the cuff using commercially available disinfectants. Using dark colored disinfectants may stain the cuff material. Test a single cuff to ensure that no damage or staining occurs. Follow the manufacturer’s instructions. Thoroughly rinse each component to remove any residual disinfectants. Once cleaned, wash off all disinfectant material using a cloth dampened with a mild detergent. Failure to remove disinfectants may lead to mild skin irritation on some patients. Allow the components to air dry for a minimum of 2 hours. 6. Cuffs may be sterilized with Ethylene Oxide. Do not autoclave or iron the cuff as the hook and loop fasteners will melt at temperatures above 325 °F (162 °C). 7. Use caution with excess liquid. 8. Do not use excessive drying techniques such as forced heat. 9. Prevent liquid from penetrating the cuff and do not attempt to clean/disinfect the cuff by submerging into liquid, autoclaving, or steam cleaning. Approved Cleaning Agents • 70% isopropyl alcohol Procedure 1. Remove sensor from patient and disconnect from sensor cable. Wipe off with alcohol pad. 2. Allow sensor to dry before placing it on a patient. These items are intended for use with a single-patient and must be properly disposed of after use. Refer to the sensor/probe manufacturer instructions for further details.

Maintenance The following table shows the recommended maintenance procedures for the Surveyor patient monitor and its accessories. The Surveyor S12 and S19 patient monitors should be serviced and calibrated once a year by a Welch Allyn authorized service technician. However, it is good practice to periodically ensure the patient monitor is in proper working order. Perform these checks at least every 12 months by a qualified biomedical engineer or other trained service personnel. To accomplish these steps in their entirety and verify the correct operation of the system, appropriate patient simulators or other equipment may be required. Refer to the service manual for further details.

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GENERAL CARE

Functionality Mechanical Integrity Power LED Speaker Second Speaker ECG / Respiration SpO2 CO2

Procedure Check for cracks, abrasive edges and other signs of damage. Verify that the green power LED is illuminated when the patient monitor is ON or charging. Power-cycle the Surveyor patient monitor and verify that the power-up speaker test tones are generated. Power-cycle the Surveyor patient monitor and verify that the power-up second speaker test tones are generated. • Connect ECG leads to Patient Simulator. • Verify proper heart rate at 30 and 300 bpm (±2 bpm or ±1%). • Verify 1 mV test pulse (Lead II). • Verify proper respiration rate at 15 and 120 bpm (±3 bpm). • Connect to Patient Simulator (select appropriate sensor type). • Verify proper % SpO2 value at 84% and 96% (±2%). • Verify proper PR value at 30 and 240 bpm (±5%). NOTE: Use only certified calibration gas apparatus [See “CO2 Calibration” section below] that has not reached its expiration date. This cal gas can be applied to the Surveyor patient monitor in pulses that simulate patient breaths. 1. Connect an Oridion Microstream FilterLine single-use capnography sample line to the Surveyor monitor’s gas inlet port. 2. Connect with a tight fit, the other end of the Oridion sample line to one of the two open ports on the Cal Gas tubing apparatus. 3. Pulse the calibration gas actuator, holding it depressed for 10 seconds and released for 10 seconds (6 bpm). This will allow enough time for the EtCO2 to stabilize in both inhaled and exhaled states. 4. Verify that the EtCO2 value reads the CO2 concentration stated on the canister ± the accuracy tolerance stated in the product specifications. 5. Verify the FiCO2 value reads 0 ±2 mmHg. NOTE: Factor a ±0.05 correction for every 100 mmHg of ambient barometric pressure above or below sea level respectively. NOTE: The monitor should be returned to the manufacturer for periodic servicing of the CO2 system after 30,000 hours of CO2 use.

32

NIBP Invasive Pressures (P1-P4) Temperature Leakage Currents

GENERAL CARE NOTE: Do not allow system to remain pressurized and stable below 20 mmHg. The monitor will remove this pressure as a zero offset and this will affect the validity of the calibration check. NOTE: The following are required to perform this test: NIBP simulator or sphygmomanometer along with a Y-cable and a hand inflation bulb. Static Pressure Transducer Test: Via the Service settings, put the NIBP in to calibration mode. Set the pressure to 25 mmHg and 225 mmHg respectively and verify that the pressure values reported by the Surveyor patient monitor matches (±2 mmHg) of that reported on the simulator or sphygmomanometer. Release pressure. Overpressure Test: Inflate cuff to 300 mmHg. Verify that the pressure is automatically dumped at 300 ±30 mmHg. Leak Test: Inflate a cuff to 150 mmHg. Allow cuff pressure to settle (thermal effect). Verify that the pressure drops less than 4 mmHg in 1 minute. Verify that the pressure is automatically dumped after 150 seconds of being above 15 mmHg. Set the NIBP back to normal mode. Power cycle the monitor. • Connect static pressure sources at 20 and later at 100 mmHg to IBP sensors P1-P4. Verify correct pressure is displayed for each (±2 mmHg). • Connect a patient simulator with dynamic IBP waveform for radial artery of 120/80. • Verify correct pressure waveform and values are displayed (±2 mmHg). None (self-checking). Connect to Safety Analyzer. WARNING: Follow safety instructions as indicated in the manual for the analyzer. • Verify Patient Lead Leakage (to ground): < 10 µA. • Verify Patient Lead Leakage (inter-lead): < 10 µA. • Verify Patient Lead Leakage (mains applied to leads): < 50 µA. • Verify Leakage to ground (normal): < 500 µA. • Verify Leakage to ground (reversed polarity): < 1000 µA. • Verify Leakage to ground (neutral opened): < 1000 µA.

WARNING: Only Welch Allyn authorized service providers should perform servicing of the Monitor to ensure that the correct maintenance and calibration procedures are followed and that the Monitor returns to proper operation.

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GENERAL CARE

Battery Replacement CAUTION: The battery should be removed from the monitor if the monitor is to be stored for an extended period of time. The battery may need to be replaced if it is no longer holding a charge. Under optimum conditions, the battery lifetime is approximately two years. Replacing the battery should only be done by qualified service personnel. WARNING: Use only APPROVED BATTERIES as listed in the Accessories section. Use of unapproved batteries may cause a hazard and will void the warranty. WARNING: Do not crush, drop, or puncture the battery as this may result in overheating and possible fire. CAUTION: Batteries should only be replaced by trained service personnel.

To replace the battery:

1. Obtain a replacement battery from Welch Allyn (see Accessories section for part number).

2. Power-off the Surveyor patient monitor.

3. On the back of the Surveyor patient monitor, disconnect the external power supply from the monitor.

4. Remove the battery cover with the VESA mounting plate by removing the four screws holding the cover as shown in Error! Reference source not found..

5. Remove the battery by pulling on the top side of the battery as shown in Error! Reference source not found..

6. Insert new battery ensuring that the connector is properly engaged.

7. Carefully reinstall back cover and screws.

8. Properly dispose of the old battery (see Decommissioning and Disposal section).

Figure 1. Removal of battery compartment screws

Figure 2. Battery removal

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GENERAL CARE

Battery Life and Charge Time

Estimated Battery Life

S12: 3 hours* S19: 2 hours*

*Fully charged new batteries at 25 °C for the following conditions: continuous ECG and SpO2, as well as NIBP measurements at every 15-minute interval.

Estimated Battery Charge Time

When OFF, 5 hours When ON, S12: 7 hours When ON, S19: 20 hours

Battery Conditions When the Surveyor S12 and S19 monitor’s battery has less than 5 minutes of power remaining, the battery icon flashes, a battery alert message displays, and an audio technical tone is sounded. When the battery power is too low to continue normal operation, the Surveyor S12 and S19 monitor’s screen clears, a Battery Nearly Depleted message displays in the center of the screen, and monitoring is discontinued. When AC power is restored, the battery begins the recharge process and monitoring can resume once the clinician has powered on the monitor. Decommissioning and Disposal Disposal must be in accordance with the following steps: 1. Follow cleaning and disinfection instructions per instructions in this user manual section. 2. Delete all existing data related to patients/hospital/clinic/doctor. Data backup may be performed prior to deletion. 3. Segregate material in preparation for the recycling process • Components are to be disassembled and recycled based on type of material o Plastic to be recycled as plastic waste o Metal to be recycled as Metals • Includes loose components containing more than 90% metal by weight • Includes screws and fasteners o Electronic components, including the power cord, to be disassembled and recycled as Waste of Electrical and Electronic Equipment (WEEE) o Batteries to be dismantled from the device and recycled as per WEEE

Users must adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the user of the device shall first contact Hillrom Technical Support for guidance on safe disposal protocols.

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GENERAL CARE Calibration The Surveyor S12 and S19 patient monitors should be serviced and calibrated once a year by a Welch Allyn authorized service technician. Refer to the service manual for further details. Trained service technicians can perform the following test and calibration procedures via the Setup > Administrator > Service (password required) > Calibration dialogue as shown below. Figure 2 Calibration Dialogue CO2 Calibration The CO2 module within the patient monitor does not require calibration during normal clinical operation. The Surveyor patient monitor displays a “CO2 Calibration Due” message when the manufacturer’s suggested number of operating hours has been reached. Calibrate the CO2 module when this message is displayed. It is recommended to calibrate the CO2 module on an annual basis or after 4000 hours of use, whichever comes first. In the first year, the CO2 module should be calibrated after 1200 hours of use. The number of hours until calibration is due may be found in the Surveyor patient monitor’s event log, which is accessed via the “Administration – System – Show Event Log” menu. NOTE: Calibration should be performed by a trained technician. NOTE: Ensure that the calibration gas and regulator are functioning properly before calibration. NOTE: Calibration of the CO2 module will require a calibrated gas mixture of 5% CO2, 21% O2, with the balance N2. The calibration kit available from Air Liquide (Scott Medical); Part Number T4653ORF-CD contains a canister of the above gas mixture, a T-piece connector and a Calibration Filterline. To calibrate the CO2 module: 1. Select “Start CO2 Calibration” via the “Administration - Service – Calibration” screen. 2. Prior to calibration initiation, connect the CO2 sampling line to the monitor. 3. Attach the calibrated CO2 gas mixture to the CO2 sampling line. 4. Select “Start CO2 Calibration” on the screen. The Surveyor patient monitor displays “CO2 Calibrating” for up to 1 minute. 5. Once completed, the Surveyor patient monitor displays “CO2 Calibration Complete” or “CO2 Calibration Failed”. 6. If the calibration fails, determine the cause of failure appropriate to the displayed error message given then repeat the CO2 calibration procedure. 7. Upon successful completion, remove the calibration gas from the monitor. NOTE: Between calibrations, the calibration gas can be applied to the Surveyor patient monitor in pulses that simulate patient breaths. The EtCO2 value should read 38 ±2 mmHg. The FiCO2 value should read 0 ±2 mmHg and a ±0.05 correction factor for every 100 mmHg ambient pressure above or below sea level respectively. 36

GENERAL CARE Invasive Pressure Calibration The Invasive Pressure interfaces do not require calibration during normal clinical operation. In order to calibrate the Invasive Pressure interfaces, perform the following: 1. Connect a static pressure source, such as ambient air, to pressure transducer that is connected to the P1 invasive pressure interface. 2. Select “Start P1 Calibration” via the “Administration - Service – Calibration” screen (password required to access this screen). 3. Await “P1 Calibration OK” message, or similar if the interface is labeled something other than P1. 4. Repeat for interfaces P2 through P4. NIBP Calibration The NIBP interface does not require calibration during normal clinical operation. The accuracy of the NIBP pressure sensor and overall functionality of the NIBP interface can be verified as detailed in the Maintenance section in this manual. If further calibration is required, contact Welch Allyn Technical Support or your authorized service personnel. 37

6. ELECTROMAGNETIC COMPATIBILITY (EMC)

When using the patient monitor, assess the electromagnetic compatibility with surrounding devices. An electronic device may either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the bedside monitor according to the international standard for EMC for medical bedside monitors (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2). The patient monitor should not be used adjacent to or stacked with other equipment. If the patient monitor is used in this manner, verify the patient monitor operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment may affect the performance of medical equipment. See Table X-4 for recommended separation distances between the radio equipment and the patient monitor. The use of accessories, transducers, and cables other than those specified by Welch Allyn may result in increased emissions or decreased immunity of the equipment. Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.

Emissions Test RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Compliance Group 1 Class A Not Applicable

Electromagnetic Environment: Guidance The Surveyor patient monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment. The Surveyor patient monitor is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Not Applicable

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ELECTROMAGNETIC COMPATIBILITY (EMC) Table X-2 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment: Guidance

Electrostatic discharge (ESD) EN 61000-4-2 Electrical fast transient/burst EN 61000-4-4 Surge IEC 61000-4-5 Voltage fluctuations and interruptions Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

+/- 6 kV contact +/- 8 kV air

+/- 6 kV contact +/- 8 kV air

+/- 2 kV for power supply lines +/- 1 kV for input/output lines +/- 1 kV differential mode +/- 2 kV common mode <5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles <5% UT for 5s 3 A/m

+/- 2 kV for power supply lines +/- 1 kV for input/output lines +/- 1 kV differential mode +/- 2 kV common mode <5% UT for 0.5 cycles 40% UT for 5 cycles 70% UT for 25 cycles <5% UT for 5s 3 A/m

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Note that monitoring is interrupted at the level “< 5% UT for 5s”, but equipment remains safe (as specified in EN 60601-1-2). Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the AC Mains voltage prior to application of the test level.

39

ELECTROMAGNETIC COMPATIBILITY (EMC) Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment.

Immunity Test Conducted RF EN 61000-4-6

IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz

Compliance Level 3 Vrms 150 kHz to 80 MHz

Electromagnetic Environment: Guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

d = 1.2

d = 1.2

80 MHz to 800 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

d = 2.3

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

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ELECTROMAGNETIC COMPATIBILITY (EMC) Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter (W) 0.01 0.1 1 10 100

Separation Distance According to Frequency of Transmitter (m)

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 0.12 m 0.38 m 1.2 m 3.8 m 12.0 m

d = 1.2 0.12 m 0.38 m 1.2 m 3.8 m 12.0 m

d = 2.3 0.23 m 0.73 m 2.3 m 7.3 m 23.0 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

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ELECTROMAGNETIC COMPATIBILITY (EMC) Regulatory Radio Compliance Federal Communications Commission (FCC) This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: • This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna • Increase the distance between the equipment and the receiver • Connect the equipment to an outlet on a circuit different from that to which the receiver is connected • Consult the dealer or an experienced radio/TV technician for help The user may find the following booklet prepared by the Federal Communications Commission helpful: The Interference Handbook This booklet is available from the U.S. Government Printing Office, Washington, D.C. 20402. Stock No. 004-000-0034504. Welch Allyn is not responsible for any radio or television interference caused by unauthorized modification of the devices included with this Welch Allyn product, or the substitution or attachment of connecting cables and equipment other than specified by Welch Allyn. The correction of interference caused by such unauthorized modification, substitution, or attachment will be the responsibility of the user. WLAN Ublox ELLA-W161-A FCC ID: PV7-WIBEAR11N-DF1 42

ELECTROMAGNETIC COMPATIBILITY (EMC) Industry Canada (IC) Emissions RF Radiation Hazard Warning Using higher gain antennas and types of antennas not certified for use with this product is not allowed. The device shall not be co-located with another transmitter. Cet avertissement de sécurité est conforme aux limites d'exposition définies par la norme CNR-102 at relative aux fréquences radio. This device complies with RSS 210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of this device. L’utilisation de ce dispositif est autorisée seulement aux conditions suivantes: (1) il ne doit pas produire de brouillage et (2) l’ utilisateur du dispositif doit étre prêt à accepter tout brouillage radioélectrique reçu, même si ce brouillage est susceptible de compromettre le fonctionnement du dispositif. This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe B est conform à la norme NMB-003 du Canada. WLAN Ublox ELLA-W161-A IC: 7738A-WB11NDF1 43

ELECTROMAGNETIC COMPATIBILITY (EMC)

European Union

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Welch Allyn tímto prohlašuje, ze tento WLAN device je ve shodě se základními požadavky a dalšími příslušnými ustanoveními směrnice 2014/53/ES. Undertegnede Welch Allyn erklærer herved, at følgende udstyr WLAN device overholder de væsentlige krav og øvrige relevante krav i direktiv 2014/53/EF Bij deze verklaart Welch Allyn dat deze WLAN device voldoet aan de essentiële eisen en aan de overige relevante bepalingen van Richtlijn 2014/53/EC. Hereby, Welch Allyn, declares that this WLAN device is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EC. Käesolevaga kinnitab Welch Allyn seadme WLAN device vastavust direktiivi 2014/53/EÜ põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele. Welch Allyn vakuuttaa täten että WLAN device tyyppinen laite on direktiivin 2014/53/EY oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen. Par la présente, Welch Allyn déclare que ce WLAN device est conforme aux exigences essentielles et aux autres dispositions de la directive 2014/53/CE qui lui sont applicables Hiermit erklärt Welch Allyn die Übereinstimmung des Gerätes WLAN device mit den grundlegenden Anforderungen und den anderen relevanten Festlegungen der Richtlinie 2014/53/EG. (Wien) ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Welch Allyn ΔΗΛΩΝΕΙ ΟΤΙ WLAN device ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 2014/53/ΕΚ Alulírott, Welch Allyn nyilatkozom, hogy a WLAN device megfelel a vonatkozó alapvetõ követelményeknek és az 2014/53/EC irányelv egyéb elõírásainak. Con la presente Welch Allyn dichiara che questo WLAN device è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 2014/53/CE. Ar šo Welch Allyn deklarē, ka WLAN device atbilst Direktīvas 2014/53/EK būtiskajām prasībām un citiem ar to saistītajiem noteikumiem. Šiuo Welch Allyn deklaruoja, kad šis WLAN device atitinka esminius reikalavimus ir kitas 2014/53/EB Direktyvos nuostatas. Hawnhekk, Welch Allyn, jiddikjara li dan WLAN device jikkonforma mal-htigijiet essenzjali u ma provvedimenti ohrajn relevanti li hemm fid-Dirrettiva 2014/53/EC Welch Allyn declara que este WLAN device está conforme com os requisitos essenciais e outras disposições da Directiva 2014/53/CE. Welch Allyn týmto vyhlasuje, ze WLAN device spĺňa základné požiadavky a všetky príslušné ustanovenia Smernice 2014/53/ES. Šiuo Welch Allyn deklaruoja, kad šis WLAN device atitinka esminius reikalavimus ir kitas 2014/53/EB Direktyvos nuostatas. Por medio de la presente Welch Allyn declara que el WLAN device cumple con los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 2014/53/CE

Swedish

Härmed intygar Welch Allyn att denna WLAN device står I överensstämmelse med de väsentliga egenskapskrav och övriga relevanta bestämmelser som framgår av direktiv 2014/53/EG.

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7. INTRODUCTION General Information This User's Guide provides information for users of the Welch Allyn Surveyor S12 and S19 patient monitors. The Surveyor S12 and S19 patient monitors are small, lightweight patient monitors designed to acquire physiological waveforms and parameters, and to transmit this data to the Surveyor Central monitoring station. The terms Surveyor patient monitor, system, patient monitor, monitor, S12, S19, and patient monitor may be used interchangeably in this document to refer to the Welch Allyn Surveyor S12 and S19 patient monitors. Prior to operating the Surveyor patient monitors, read all sections of this User's Guide. Failure to read and understand the instructions may lead to misuse of the Surveyor patient monitor resulting in harm to the clinician and patient. Intended Use (Functional Purpose) The Surveyor Patient Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility. It is designed for continuous monitoring in either stationary or portable applications. It is intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output. Indications for Use The Surveyor Patient Monitor is indicated for use in adult, adolescents and children patient populations for the monitoring of the following parameters: • Non-invasive blood pressure • Impedance respiration • Invasive blood pressure • Temperature • Functional arterial oxygen saturation (SpO2) • End-tidal & inspired CO2 • ECG monitoring with arrhythmia & ST-segment • 12-Lead resting ECG • Cardiac output The Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters: • Non-invasive blood pressure • Impedance respiration • Invasive blood pressure • Temperature • Functional arterial oxygen saturation (SpO2) • End-tidal & inspired CO2 • ECG monitoring with arrhythmia • 12-Lead resting ECG The Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. The ‘Bed to Bed communication’ feature allows remote viewing of monitors when connected to a Surveyor Central Station. 45

Product Description

INTRODUCTION

The Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations. Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, non-invasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO2), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output. The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Surveyor Network, the Surveyor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms. The Surveyor S12, S19, with software version 3.0.1 or later has added Wireless LAN capability that allows remote viewing of monitors when connected to a Surveyor Central Station.

WARNING: The Surveyor S12 and S19 patient monitors do not perform apnea monitoring. The Surveyor patient monitor is not intended for transport applications such as ambulances or aircraft.

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INTRODUCTION System Overview The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications. The Surveyor S19 is intended for continuous monitoring in a stationary application. The S12 has an 11.6 inch display, and the S19 has an 18.5 inch display. Front View - Figure 3 Surveyor Patient Monitor: Front View Example 1 2 3 1. Alarm Light 2. Main Screen Display Area 3. Power On/Off Button and LED The S12/S19 front bezel provides a LED indicator to indicate when the monitor is connected to AC (wall) power. Left Side View - Figure 4 Surveyor Patient Monitor: Left Side Connector Ports The left side of the S12 and S19 contains the patient cable connections for ECG monitoring, SpO2 NIBP, P1-P4, cardiac output, CO2 temperature, and 12-lead resting ECG. NOTE: These cable connection ports are dependent upon the purchased monitor configuration. 1. ECG Connector 2. SpO2 3. NIBP 4. P1 & 2 5. P3 & 4 6. Cardiac Output 7. CO2 Input Port 8. T1 9. T2 10. AM12M 12-Lead ECG Acquisition Module/USB Port 47

INTRODUCTION AM12M Acquisition Module The AM12M includes a DB15 connector to allow connection of an ECG patient cable, such as the 10-wire J-Screw patient cable shown in the picture below, to obtain 12-lead ECG at the Surveyor S12/S19 patient monitor. The AM12M cable is connected to the 12-Lead ECG Acquisition Module USB Port. Right Side View Figure 5 Surveyor Patient Monitor: Right Side View of S12 with Optional Bedside Recorder The right side of the Surveyor S12 may contain the optional integrated dual channel thermal recorder (1). 1 Back View Figure 6 Surveyor Patient Monitor: Top Back View of S12 The top corner of the back of the Surveyor S12 and S19 contains the communication ports, an opening for the audio speaker as well as a connection for CO2 exhaust. This area contains the connections for wired Ethernet, an external alarm indicator, a serial port for other medical device interfaces, and AC power. Power is provided through an external medical-grade power supply or an internal lithium-ion battery. 1 48