Surveyor S12 and S19 Service Manual Rev R Dec 2019

©2019 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. Welch Allyn is a registered trademark of Welch Allyn, Inc. Surveyor™, AM12M™, and VERITAS™ are trademarks of Welch Allyn, Inc. Nellcor™, Covidien™, C-LOCK™, SatSeconds™, OxiMax™, MAX™, Max-Fast™, SoftCare™, Oxiband™, DuraY™, PediCheck™, OxiCliq™, and Durasensor™ are trademarks of Nellcor Puritan Bennett Inc. Smart Capnography™, Smart Breath Detection Algorithm™ (BDA™), Smart Alarm Respiratory Analysis ™ (SARA), Integrated Pulmonary Index™ (IPI), Microstream®, Filterline® and Capnoline® are trademarks or registered trademarks of Oridion Medical Ltd. Edwards® is a registered trademark of Edwards Lifesciences Corporation. Oridion CO2 License Information -- NO IMPLIED LICENSE – Possession or purchase of this bedside monitor does not convey any express or implied license to use the bedside monitor with unauthorized consumable CO2 sampling products which would, alone, or in combination with this bedside monitor, fall within the scope of one or more patents relating to this bedside monitor and/or CO2 sampling consumable products. The capnography component of this product is covered by one or more of the following US patents: 6,428,483; 6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications pending. All other trademarks and registered trademarks are the property of their respective owners. For patent information, please visit www.welchallyn.com/patents For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-us/locations.html Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html 1.888.667.8272, [email protected] 9516-183-50-ENG Rev R Revision Date: 2019-12 901138 PATIENT MONITOR

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA www.welchallyn.com

EU IMPORTER Welch Allyn Limited Navan Business Park, Dublin Road, Navan, Co. Meath C15 AW22 Ireland

TABLE OF CONTENTS TABLE OF CONTENTS 1. NOTICES .................................................................................................................................................. 4 MANUFACTURER’S RESPONSIBILITY ..................................................................................................................... 4 RESPONSIBILITY OF THE CUSTOMER ................................................................................................................... 4 EQUIPMENT IDENTIFICATION ............................................................................................................................4 COPYRIGHT AND TRADEMARK NOTICES ............................................................................................................. 4 OTHER IMPORTANT INFORMATION ..................................................................................................................4 NOTICE TO EU USERS AND/OR PATIENTS ........................................................................................................... 4 2. WARRANTYINFORMATION ................................................................................................................5 YOUR WELCH ALLYN WARRANTY.......................................................................................................................5 3. USERSAFETYINFORMATION ...............................................................................................................7 SAFETY REGULATIONS..........................................................................................................................................7 WARNING(S) ..........................................................................................................................................................7 POWERWARNINGS .....................................................................................................................................................8 ACCESSORIES, CABLES, AND EXTERNAL CONNECTIONS WARNINGS .......................................................................................10 USE WITH ELECTRO SURGERY DEVICES WARNINGS ...........................................................................................................11 INSTALLATION AND MOUNTING WARNINGS....................................................................................................................11 ECG WARNINGS.......................................................................................................................................................11 ECG CALCULATED HEART RATE WARNINGS ................................................................................................................... 12 WARNINGS FOR PATIENTS WITH PACEMAKERS ................................................................................................................13 RESPIRATIONWARNINGS ............................................................................................................................................13 SPO2 WARNINGS .....................................................................................................................................................13 NIBP WARNINGS......................................................................................................................................................15 INVASIVE PRESSURE WARNINGS ...................................................................................................................................16 CO2 WARNINGS.......................................................................................................................................................16 CARDIAC OUTPUT WARNINGS......................................................................................................................................17 CAUTIONS ...............................................................................................................................................................18 NOTES .............................................................................................................................. .................................... 19 4. EQUIPMENTSYMBOLSANDMARKINGS.......................................................................................... 21 SYMBOL DELINEATION .......................................................................................................................................21 5. ELECTROMAGNETIC COMPATABILITY (EMC) ................................................................................. 23 TABLE X-1 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS .................................................. 24 TABLE X-2 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY .................................................. 24 TABLE X-3 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY .................................................. 25 TABLE X-4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT .............................................................................................................................. ............................... 26 6. GENERAL CARE AND MAINTENANCE .............................................................................................. 27 PRECAUTIONS .............................................................................................................................. ....................... 27 INSPECTION.............................................................................................................................. ........................... 27 CLEANING ............................................................................................................................................................27 DISPOSAL .............................................................................................................................. ............................... 29 MAINTENANCE .............................................................................................................................. ...................... 30 SAFETY TESTING .......................................................................................................................................................32 BATTERY REPLACEMENT ....................................................................................................................................35 1

TABLE OF CONTENTS BATTERY LIFE AND CHARGE TIME..................................................................................................................................35 BATTERYCONDITIONS ................................................................................................................................................36 DECOMMISSIONING AND DISPOSAL ...................................................................................................................36 CALIBRATION ......................................................................................................................................................36 CO2CALIBRATION ....................................................................................................................................................36 INVASIVE PRESSURE CALIBRATION .................................................................................................................................37 NIBP CALIBRATION ...................................................................................................................................................37 S12/S19 PREVENTATIVE MAINTENANCE RECORD...........................................................................................38 8. DEVICESETUP ..................................................................................................................................... 39 OVERVIEW .............................................................................................................................. ............................. 39 PATIENT INFORMATION....................................................................................................................................39 PARAMETERS .............................................................................................................................. ......................... 39 WAVEFORMS.............................................................................................................................. ......................... 40 RECORDER ...........................................................................................................................................................42 ARRHYTHMIA.............................................................................................................................. ........................ 43 ALARM SUSPEND.................................................................................................................................................44 ALARMS ...............................................................................................................................................................44 AUDIO .............................................................................................................................. .................................... 46 RESTORE DEPARTMENTAL DEFAULTS ...............................................................................................................47 ADMINISTRATION ..............................................................................................................................................47 CONFIGURATION.............................................................................................................................. ......................... 48 COMMUNICATIONS ...................................................................................................................................................48 SCREEN CLEANING.....................................................................................................................................................49 ADMINISTRATION SETUP ALARMS DIALOGUE .................................................................................................................. 49 ADMINISTRATION SETUP SYSTEM DIALOGUE ...................................................................................................................51 ADMINISTRATION SETUP SERVICE DIALOGUE...................................................................................................................52 ADMINISTRATION SETUP FACTORY DIALOGUE ................................................................................................................. 52 9. UNIT DISSASSEMBLY ......................................................................................................................... 53 BATTERY REMOVAL & REPLACEMENT..............................................................................................................56 REAR HOUSING REMOVAL & REPLACEMENT ..................................................................................................57 PROCESSOR BOARD REMOVAL & REPLACEMENT ...........................................................................................60 MAIN BOARD REMOVAL & REPLACEMENT .....................................................................................................61 LCDREMOVAL&REPLACEMENTS12 ................................................................................................................63 LCDREMOVAL&REPLACEMENTS19 ................................................................................................................64 REMOVAL AND REPLACEMENT OF THE OPTIONAL THERMAL WRITER (S12 ONLY) ..................................66 OPTIONALTHERMALWRITERFORTHES19 ......................................................................................................69 10. CONFORMANCE TESTING .............................................................................................................. 81 REQUIRED EQUIPMENT:............................................................................................................................. ................. 81 1.0 POWERTESTING ..........................................................................................................................................82 2.0 FUNCTIONALTESTING ...................................................................................................................................82 3.0 DEVICECLEANING ......................................................................................................................................110 4.0 SAFETYTESTING.........................................................................................................................................111 11. PRODUCT SPECIFICATIONS........................................................................................................... 115 GENERAL SPECIFICATIONS ...............................................................................................................................115 ENVIRONMENTAL CONDITIONS.......................................................................................................................115 POWER REQUIREMENTS &BATTERY...............................................................................................................116 DISPLAY SPECIFICATIONS ...............................................................................................................................116 RECORDER SPECIFICATIONS............................................................................................................................. 116 MOUNTING SPECIFICATIONS .........................................................................................................................117 2

TABLE OF CONTENTS TRENDING.............................................................................................................................. ............................ 117 12. PARAMETER SPECIFICATIONS....................................................................................................... 118 PATIENT POPULATION ....................................................................................................................................118 WAVEFORMS.............................................................................................................................. ....................... 118 ECG ....................................................................................................................................................................118 ARRHYTHMIA ANALYSIS...................................................................................................................................119 ST ANALYSIS......................................................................................................................................................120 NON-INVASIVE BLOOD PRESSURE (NIBP) ......................................................................................................121 PULSE OXIMETRY (SPO2).................................................................................................................................121 TEMPERATURE ..................................................................................................................................................122 RESPIRATIONS: VIA ECG IMPEDANCE.............................................................................................................122 CAPNOGRAPHY (CO2) .......................................................................................................................................122 INVASIVE PRESSURES.........................................................................................................................................123 CARDIAC OUTPUT.............................................................................................................................................124 13. PARAMETERALARM LIMIT RANGES ........................................................................................... 126 ADULT PATIENT MODE....................................................................................................................................126 PEDIATRIC PATIENT MODE.............................................................................................................................. 128 14. ALARM SPECIFICATIONS ............................................................................................................. 130 GENERAL ALARMS............................................................................................................................................130 ECG AND HR MESSAGES .................................................................................................................................130 NON-INVASIVE BLOOD PRESSURE (NIBP) MESSAGES ...................................................................................131 PULSE OXIMETRY (SPO2) MESSAGES..............................................................................................................133 TEMPERATURE MESSAGES................................................................................................................................134 RESPIRATION MESSAGES ..................................................................................................................................135 CAPNOGRAPHY (CO2) MESSAGES ...................................................................................................................136 INVASIVE PRESSURE MESSAGES .......................................................................................................................137 CARDIAC OUTPUT MESSAGES...........................................................................................................................138 NETWORK MESSAGES..............................................................................................................................................138 15. TROUBLESHOOTING.................................................................................................................... 139 POWER AND BATTERY......................................................................................................................................139 DISPLAY AND TOUCH SCREEN .........................................................................................................................139 ECG, ARRHYTHMIA, AND ST............................................................................................................................140 NON-INVASIVE BLOOD PRESSURE (NIBP) ......................................................................................................140 PULSE OXIMETRY (SPO2).................................................................................................................................141 TEMPERATURE ..................................................................................................................................................141 RESPIRATIONS: VIA ECG THORACIC IMPEDANCE .........................................................................................141 CAPNOGRAPHY (CO2) .......................................................................................................................................141 INVASIVE PRESSURES.........................................................................................................................................142 CARDIAC OUTPUT.............................................................................................................................................142 WLAN CONNECTIVITY .............................................................................................................................................143 16. MOUNTING ACCESSORIES ........................................................................................................... 147 QUICK DISCONNECT (M-SERIES) WALL MOUNTING COMPONENTS ..............................................................147 VALUE (VESA M-SERIES) WALL MOUNTING COMPONENTS............................................................................ 147 PREMIUM (VHM-25) WALL MOUNT COMPONENTS ....................................................................................148 SURVEYORS12ROLLSTANDCOMPONENTS(NOTTOBEUSEDWITHS19) ....................................................149 3

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, only if article 2 of 93/42/EEC directive is applied, in particular:

•

WARNING: System installation and assembly operations, extensions, readjustments, modifications or

repairs are carried out by personnel authorized by 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.

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.

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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. 5

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 A N D W E L C H A L L Y N I S 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. 6

3. USER SAFETY INFORMATION

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

Caution:

Means there is the possibility of damage to the patient monitor.

Note:

Provides information to further assist in the use of the patient monitor.

NOTE: This manual may contain screen shots and pictures. Any screen shots and pictures are provided for reference only and are not intended to convey actual operating techniques. Consult the actual screen in the host language for specific wording. Safety Regulations

• Surveyor is a medical patient monitor.

• Surveyor and its accessories are

labeled, according to European directive 93/42/EEC (MDD), as a class

IIb patient monitor, and class I medical patient monitors respectively.

• Surveyor with all accessories that have a physical or logical connection with it, forms part of a Medical

Electrical System. Surveyor complies with various safety and performance regulations as mentioned in this

manual (Applied Standards).

WARNING(S) • 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. • To ensure the safety of both the patient and the device, 1.5 meters (5’) of open area should surround the patient.

7

USER SAFETY INFORMATION • A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture. Do not mount any part of the device closer than 25 cm from outlets of flammable gases, including oxygen. • For proper operation and the safety of users or patients and bystanders, equipment and accessories must be connected only as described in this manual. • 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. • If additional devices beyond Surveyor are connected to the patient, leakage currents through the patient might add up and should be accounted for. • 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. 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 8

and of transformer overload.

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 attempt to crush or drop the device. 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. • 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. 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.

9

Accessories, Cables, and External Connections Warnings

USER SAFETY INFORMATION

• 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.

• 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.

• Connected devices must stay outside of the patient environment, and must be electrically insulated from the Surveyor by a separation device, or alternatively a permanent additional safety ground must be attached to the Surveyor using the appropriate terminal at the back of the unit. Connecting additional devices to the patient monitor may increase chassis and/or patient leakage currents. To maintain operator and patient safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be measured to confirm no electric shock hazard exists.

• Do not use excessive force on 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.

• 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 manualstogether.

• 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. 10

Use with Electro Surgery Devices Warnings

USER SAFETY INFORMATION

• The Surveyor is approved for use in the presence of electrosurgical (ESU) equipment providing the following precautions are taken: o To minimize the risk of patient burns, only use ESU equipment that monitors the impedance of the ESU return wires. o Users should be properly trained in the operation of the ESU equipment. o The AM12M 12-Lead ECG Acquisition Module should NOT be used when operating ESU equipment. o Keep patient-applied cables (e.g., ECG lead wires) off of earth ground and away from the ESU knife and return wires to prevent burns to measurement sites. o To prevent burns to the patient in the event of a defective neutral ECG electrode of the device, it is necessary to place ECG electrodes far from the neutral electrode, and as equidistant as possible from the blade-neutral axis of the surgical patient monitor. o When activating the ESU device, the ECG signals may be distorted or may disappear, and Lead Fail or Noise alarms might be present. The signal should return once the ESU activation stops. o When activating the ESU device, using the SpO2 parameter as the heart rate source rather than the ECG parameter to determine heart rate may be clinically preferred.

Installation and Mounting Warnings

• Place the Surveyor on a flat and leveled surface or mount it according to the manufacturer’s instructions. 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 potentially create a hazard to patients and hospital personnel. • Only approved rolling stands and wall-mount fixtures should be used with the Surveyor. • 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 Surveyor Central monitoring station

• 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. • Patient cables intended for use with the patient monitor include series resistance (9 Kilo Ohm minimum) in each lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to use. • ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation. 11

USER SAFETY INFORMATION • Defibrillation protection is guaranteed when the original Welch Allyn ECG patient cables are used. • 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™ 12lead 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. • 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. • 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. • For full diagnostic quality, the resting ECG should be printed on the Surveyor Central Station printer and not on the S12 or S19 strip chart recorder. 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 ANSI/AAMI EC13 and IEC60601-2-27. • Tall and peaked T-waves may affect QRS detection resulting in doubled heart rates. Surveyor rejects tall T-Waves less than or equal to 240% of a 1mV QRS in diagnostic mode, and 70% of a 1mV QRS in monitoring mode, as well as a Q-T interval of 350 ms measured for both diagnostic and monitoring modes according to ANSI/AAMI EC13 and IEC 60601-2-27. • The heart rate meter correctly detects all beats of the alternating beat type waveforms considered in ANSI/AAMI EC 13 and IEC 60601-2-27 Figure 201.101 patterns A1-A4 if the QRS amplitudes exceed the minimum detection threshold set by the user. • Time to tachycardia, as measured according to ANSI/AAMI EC13 and IEC 60601-2-27 Figure 201.101 patterns B1-B2 is less than 8 seconds. • Heart rate indication is not reliable during episodes of ventricular fibrillation. • The summarized performance of the QRS recognition and classification algorithm on standard databases, as defined by ANSI/AAMI EC 57, is as follows: 12

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

USER SAFETY INFORMATION

Welch Allyn 99.94 99.87 95.49 97.05 0.220

AHA Database Welch 99.86 99.90 93.49 98.32 0.162

• Because of noise, artifact and the many different physiological manifestations of the ECG signal, it is inevitable that some beats are not detected or correctly classified by the system. The user is advised not to rely completely on automatic alarm systems for the monitoring of critical patients. 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 the ANSI/AAMI EC 13 and IEC 60601-2-27 standards. • When using the AM12M 12-lead ECG Acquisition Module, pacemaker spikes in the range of 0.3 to 1.3 mS, +/2 to +/-700 mV are recognized and rejected according to the ANSI/AAMI EC13 and IEC 60601-227:2011standards. • The pacemaker rejection software can be deactivated by the user. This should not be done for patients with a pacemaker or suspected to have a pacemaker implanted because this can lead to a heart rate indication and failure to alarm for 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.

13

USER SAFETY INFORMATION • 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: 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 Severevasoconstriction 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 CO-oximeter to completely understand the patient’s condition. Check that the pulse oximetry waveform is physiological in shape. • To prevent erroneous readings, do not use physically damaged sensors, cables or modules. Discard a damaged sensor or cable immediately. 14

USER SAFETY INFORMATION • The performance of the pulse oximetry may be compromised by excessive motion including tremors or shivering. • 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 cuffs to determine whether a particular cuff fits the patient’s arm or not. • The Surveyor patient monitor is not intended for use with neonates. • Do not fold, clamp, cut, or alter the pressure hose of the cuff or the monitor. • Periodically check the limb connected to the cuff for adequate perfusion, circulation, and function. Repeated NIBP measurements can lead to hematomas, limb ischemia, and other limb injuries. Kinked or blocked hoses can lead to prolonged impairment 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. • 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. 15

USER SAFETY INFORMATION • 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 CO2 Purging Line will appear in the message area. If the sampling line cannot be cleared, the message CO2 occluded line will appear in the message area. Replace the sampling line once the CO2 occluded line message appears. 16

Cardiac Output Warnings

USER SAFETY INFORMATION

• 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 Clot formation on the thermistor port. o Anatomical abnormalities, (for example, cardiac shunts). o Excessive patientmovement. 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.

17

USER SAFETY INFORMATION 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. • 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 agents, failure to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm to users, patients and bystanders, or damage to the 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. • 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 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. 18

USER SAFETY INFORMATION • 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 medicalwaste. • 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. • 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. • 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 frequentreplacement. • 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. 19

• The device is ETL listed:

USER SAFETY INFORMATION

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.

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4. EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation

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;

IPX1

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 Defibrillator-proof type CF applied part External power AC/DC power supply; use only Welch Allyn Power Supply; REF 4101012

Power On/Off switch

Follow instructions/directions (DFU) – mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn 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 3/5 lead ECG parameter

Connector for 12-lead ECG parameter using Welch Allyn AM12M

Connector for non-invasive blood pressure parameter

Connector for oxygen saturation parameter

CO

Connector for cardiac output parameter

Connector for invasive pressure 1 & 2 parameters

Connector for invasive pressure 3 & 4 parameters

Connector for temperature 1 parameter

Connector for temperature 2 parameter

21

Connector for CO2 parameter This end up Fragile, handle with care Storage temperature range Recorder interface (S19 only) Model Identifier

EQUIPMENT SYMBOLS AND MARKINGS

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

Keep away from sunlight

Keep dry

10 rolls of recorder paper per case Medical Device Reorder Number

22

5. ELECTROMAGNETIC COMPATABILITY (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. 23

ELECTROMAGNETIC COMPATABILITY (EMC) 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

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.

Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3

Not Applicable

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 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

IEC 60601 Test Level +/- 6 kV contact +/- 8 kV air

Compliance Level +/- 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

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

24

ELECTROMAGNETIC COMPATABILITY (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

IEC 60601 Test Compliance

Level

Level

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

Conducted RF EN 61000-4-6 Radiated RF IEC 61000-43

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

d = 1.2

d = 1.2

80 MHz to 800 MHz

d =

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.

25

ELECTROMAGNETIC COMPATABILITY (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.

26

6. GENERAL CARE AND MAINTENANCE 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. Do not use the equipment and contact an authorized service representative for servicing if there are concerns about integrity of the system. • Verify that all 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. 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. 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. 27

GENERAL CARE AND MAINTENANCE 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.

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

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.

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

GENERAL CARE AND MAINTENANCE 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. Sterilize 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.

Disposal This product and its accessories must be disposed of according to the local laws and regulations. Do not dispose of this product as unsorted municipal waste. For more specific disposal information see www.welchallyn.com/weee.

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GENERAL CARE AND MAINTENANCE

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.

Functionality

Procedure

Mechanical Integrity

Check for cracks, abrasive edges and other signs of damage.

Power LED Speaker

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.

Second Speaker ECG / Respiration SpO2

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.

CO2

1. NOTE: Between calibrations, the ETCO2performance parameters and tolerance can be verified as needed as well as during preventive maintenance. The calibration gas should be applied to the Surveyor patient monitor in pulses of 5 seconds on and 5 seconds off, to simulate patient breaths of 5-6 RR. Continue long enough for the ETCO2 to stabilize in both inhale and exhale states. 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. 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 5 seconds and released for 5 seconds (5-6 RR). 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 100mmHg 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.

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Functionality NIBP Invasive Pressures (P1-P4) Temperature

GENERAL CARE AND MAINTENANCE Procedure 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. Pressure Accuracy 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 180 seconds. Set the NIBP back to normal mode. Power cycle the monitor. Measurement Accuracy Test: Connect to Patient Simulator and take a NIBP measurement. Verify proper NIBP value at 120/80 (+/- 5 mmHg). • 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 of120/80. • Verify correct pressure waveform and values are displayed (+/- 2 mmHg). None (self-checking).

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Safety Testing

GENERAL CARE AND MAINTENANCE

If the monitor housing was opened for repair or inspection work, the following safety tests should be performed in accordance with the IEC 60601-1 or IEC 62353 methods and limits. The S12 and S19 are considered a Class 1 Type CF devices, intended to be utilized with the Welch Allyn specified patient modules and product accessories.

DC Hi-pot Testing Applies to all of the following optional patient inputs (applied parts) installed on the monitor being tested. Test connectors are required to properly connect test equipment to the applied part inputs to perform Hi-pot testing. The negative (black) connection of the tester should be connected to the DC Power Input via TF0571 (or equivalent). The positive (red) lead wire is connected to the connection defined below.

The ECG input should be tested separately, and the other applied parts (SpO2, Temp, CO) can be connected together via a shorting bar (as shown in the diagram below) to expedite the testing process. This is not a requirement and the tests can be performed separately.

Connection ECG SpO2 Temp 1, Temp 2 Cardiac Output

Test Connector/Method Patient cable 9293-050-60 and shorting bar TF0281 TF0559 TF0558

Item Applied Potential Ramp Time Dwell Time Current High Current Low

Value 5000 3.0 1.0 0.500 0.0

(500 uA)

Unit of Measure Volts DC Seconds Seconds mA mA

Boundary Minimum Minimum Minimum Maximum Minimum

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GENERAL CARE AND MAINTENANCE Nurse call / Ethernet Test: The ports on the back of the device (nurse call/ethernet) are tested at a different voltage as defined below. The negative (black) connection of the tester should be connected to the DC Power Input via TF0571 (or equivalent). The positive (red) lead wire is connected to TF0570.

Connection Nurse Call/Ethernet

Test Connector/Method TF0570

Item Applied Potential Ramp Time Dwell Time Current High Current Low

Value 1000 3.0 1.0 0.500 0.0

(500 uA)

Unit of Measure Volts DC Seconds Seconds mA mA

Boundary Minimum Minimum Minimum Maximum Minimum

AC Hi-pot Testing Applies to all of the following optional patient inputs (applied parts) installed on the monitor being tested. Test connectors are required to properly connect test equipment to the applied part inputs to perform Hi-pot testing. The negative (black) connection of the tester should be connected to both the Line and Neutral on the AC side of the external AC/DC Power Module (Item # 4101-012), typically by utilizing tool TF-0107. The positive (red) lead wire is connected to the connection defined below. The ECG input should be tested separately, and the other applied parts (SpO2, Temp, CO) can be connected together via a shorting bar (as shown in the diagram below) to expedite the testing process. This is not a requirement and the tests can be performed separately.

Connection ECG SpO2 Temp 1, Temp 2 Cardiac Output

Test Connector/Method Patient cable 9293-050-60 and shorting bar TF0281 TF0559 TF0558

Item

Value

Unit of Measure

Applied Potential 3000

Volts AC

Ramp Time

3.0

Seconds

Dwell Time

1.0

Seconds

Current High

0.500 (500 uA)

mA

Current Low

0.0

mA

For Brazil testing, dwell time is increased to 60 seconds.

Boundary Minimum Minimum Minimum Maximum Minimum

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ECG Input Connection Diagram:

GENERAL CARE AND MAINTENANCE

Applied Part Connection Diagram:

Leakage Testing The factory External AC/DC Power Module (Item # 4101-012) and appropriate regional AC power cord should be used to perform the leakage tests defined below. • Earth Leakage • Enclosure Leakage Non-conductive (fully insulated) chassis testing should be performed utilizing 200 cm2 conductive foil or equivalent. • Patient Leakage Applied part – patient input (utilize Welch Allyn patient cable 9293-050-60 or -61) • Patient Leakage (mains on applied part) Applied part – patient input (utilize Welch Allyn patient cable 9293-050-60 or -61) 34

Battery Replacement

GENERAL CARE AND MAINTENANCE

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.

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 the picture below. 5. Remove the battery by pulling on the top side of the battery as shown in Figure 1. 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 Disposal section). Figure 1 Battery Replacement

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 ChargeTime

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

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Battery Conditions

GENERAL CARE AND MAINTENANCE

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

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 incinerate or throw the battery in garbage.

Calibration Welch Allyn recommends Surveyor S12 and S19 patient monitors be serviced annually by an authorized service technician. Please read the calibration section in its entirety before beginning service. CO2 Calibration The CO2 module is calibrated by the manufacturer, therefore a new patient monitor can be put into clinical use without the need of calibration. The Surveyor patient monitor displays a “CO2 Calibration Due” message when the manufacturer’s suggested number of operating hours has been reached. In the first calibration cycle, the CO2 module should be calibrated after 1200 hours of use. Subsequent calibration cycles are alerted after 4000 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: Verify the calibration gas has not expired. NOTE: After calibration, the device’s next-calibration timer automatically resets to 4000 hours, unless the calibration was done prematurely (less than 720 hours after the last calibration), in which case it is reset to 1200 hours. It is therefore recommended to perform calibration only when the device has been displaying the “CO2 Calibration Due” message. 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 T4653ORFCD contains a canister of the above gas mixture, a T-piece connector and a Calibration Filterline.

36

GENERAL CARE AND MAINTENANCE To calibrate the CO2 module: 1. Prepare the gas apparatus by attaching the sample line to the calibration gas canister. Mate the shorter of the two orange connectors of the sample line with the clear connector found on the larger tubing, all supplied with the calibration kit. Verify that the gas apparatus is functioning properly by very briefly depressing the actuator and listening for gas expulsion. Set aside. 2. Power on the S12/19 device and verify the ETCO2 function is enabled by navigating through the following menus: Setup > Parameters > ETCO2 Enabled = Yes > OK > Close. 3. Connect the CO2 sampling line to the S12/19 device by inserting the orange connector into the Microstream receptacle and turning clockwise half a turn. Do not over tighten. 4. Navigate through the following menus: Setup > Administration > Service > Code Entry 53, 51, 54 > OK > Calibration. 5. Select Start CO2 Calibration on the screen while immediately depressing and holding the gas canister actuator/trigger for approximately 1 minute. The Surveyor patient monitor will display “CO2 Calibrating” at the bottom of the screen. 6. Once completed, the Surveyor patient monitor displays “CO2 Calibration Okay” or “CO2 Calibration Failed”. 7. If the calibration fails, determine the cause of the failure appropriate to the displayed error message given. Repeat the CO2 procedure. If the calibration is unsuccessful after 3 attempts, contact Welch Allyn Technical Support. 8. Upon successful completion, disconnect the calibration gas and hold the power button to power down the S12/19 device. It is not necessary to exit out of the calibration menus. 9. Turn monitor on and reconnect the CO2 sampling line to the S12/19 device in preparation for verifying ETCO2 performance is within specified tolerances. 10. Apply the calibration gas to the Surveyor patient monitor in pulses of 5 seconds on, 5 seconds off, to simulate patient breaths of 5-6 RR. Continue long enough for the ETCO2 to stabilize in both inhale and exhale states, or approximately 1.5-2 sweeps across the screen. 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. Invasive Pressure Calibration The Invasive Pressure interfaces are calibrated by the manufacturer therefore a new patient monitor can be put into clinical use without the need of calibration. Annual Invasive Pressure calibration is recommended after the first year of use. In order to calibrate the Invasive Pressure interfaces, perform the following steps: 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 module is calibrated by the manufacturer therefore a new patient monitor can be put into clinical use without the need of calibration. 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. Based on the results of the verification testing, calibration may be required. If further calibration is required, contact Welch Allyn Technical Support or your authorized service personnel. 37

GENERAL CARE AND MAINTENANCE S12/S19 Preventative Maintenance Record Unit Serial #:

1.0 □

Mechanical Integrity

2.0 □

Device Cleaning

3.1 Functional Testing

Power LED Speaker Test Second Speaker Test ECG/Respiration SpO2 CO2 NIBP

PASS / FAIL (circle)

PASS / FAIL (circle)

PASS / FAIL (circle)

PASS / FAIL (circle)

PASS / FAIL / N/A

(circle)

PASS / FAIL / N/A

(circle)

PASS / FAIL / N/A

(circle)

Pressure Accuracy (+/- 2mmHg) Overpressure Leak Test Measurement Accuracy

25,______mmHg 225, _______mmHg mmHg (300 +/- 30 mmHg) mmHg drop (<4mmHg after 1 min) / mmHg (monitor reading)

IBP (P1-P4) Temperature 4.0 Calibration CO2 IBP (P1-P4) NIBP

PASS / FAIL / N/A PASS / FAIL / N/A

(circle) (circle)

Cal performed / Not performed (circle one) Cal performed / Not performed (circle one) Cal performed / Not performed (circle one)

If calibration was performed, a second test record should be completed to verify proper operation.

5.0 Safety Testing DC Hi-pot Testing (ECG and applied parts) DC Hi-pot Testing (nurse call/ethernet) AC Hi-pot Testing (ECG and applied parts) Leakage Testing (attach test report)

Overall Testing Results

PASS / FAIL

Performed by:

(circle) Date:

PASS / FAIL PASS / FAIL PASS / FAIL PASS / FAIL

/

/

38

8. DEVICE SETUP Overview The Setup quick action key provides access to advanced functions such as arrhythmia settings, alarm settings, and other monitor configuration menus. Example Setup Dialogue Patient Information The Patient Information button provides access to the Patient Information dialogue. Access to this dialogue can also be obtained by selecting the black patient information area located above the system date and time. Information that can be entered includes Last Name, Middle Initial, First Name, ID, Room number, Mode, Gender, Ethnicity, Date of Birth, Height and Weight. Refer to the Patient Information dialogue section in this manual for further details. To access the Patient Information dialogue from the Setup dialogue: 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Patient Information button to access the Patient Information dialogue. Parameters The Setup Parameters dialogue is where the clinician can enable and disable the monitoring of certain parameters. Disabling a parameter removes that parameter from the patient monitor’s main screen. 39

Example Setup Parameters Dialogue

DEVICE SETUP

To enable/disable a parameter: 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Parameters button to access the Setup Parameters dialogue. 3. Locate the parameter label. 4. For ST Enabled, ETCO2 Enabled, and CO Enabled: a. Select Yes to enable the parameter. b. Select No to disable the parameter. 5. For IBP Channels, select the arrow to display the drop-down list box: a. Select 2 to enable P1 and P2. b. Select 4 to enable P1, P2, P3, and P4. c. Select None to disable all invasive pressure channels. 6. For Temperature Display Mode, select the arrow to display the drop-down list box: a. Select T1 only to display only T1 on the main screen. b. Select T1 and T2 to display both temperatures on the main screen. c. Select T1 and L'T to display T1 and L'T on the main screen. 7. Select the OK button to enter that change OR select the Cancel button to cancel the changes. Waveforms The Setup Waveform Area dialogue is where the clinician can choose which waveforms are displayed on the main screen, the size of those waveforms, and the sweep speed of those waveforms. This dialogue is also where the clinician can choose to overlap the invasive pressures on the main screen.

40

Example Setup Waveform Area Dialogue

DEVICE SETUP

To select a waveform for display on the main screen: 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Waveforms button to access the Setup Waveform Area dialogue. 3. The numbers 1-7 indicate waveform position on the main screen. a. Waveform position #1 is always reserved for an ECG tracing. b. Waveform positions #4-7 are always reserved for an invasive pressure tracing c. The waveform selections are based on monitor options, ECG lead set, and the parameters that have been enabled/disabled in the Setup Parameters dialogue. 4. Choose the desired waveformposition. 5. Select the arrow to display the drop-down list box of available waveform choices. 6. Select the OK button to enter that change OR select the Cancel button to cancel the changes. To select a waveform size for display on the main screen: 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Waveforms button to access the Setup Waveform Area dialogue. 3. Locate the Size label next to the parameter requiring adjustment. 4. Select the arrow to display the drop-down list box of available waveform size choices. a. The choices available are based on the specific waveform parameter. b. Select the desired waveformsize. 5. Select the OK button to enter that change OR select the Cancel button to cancel the changes. To select the sweep speed for waveforms displayed on the main screen: 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Waveforms button to access the Setup Waveform Area dialogue. 3. Locate the Sweep Speed label. 4. Select the arrow to display the drop-down list box (Choices include 6.25 mm/s, 12 mm/s, and 25 mm/s). 5. Select the sweep speed desired. 6. Select the OK button to enter that change OR select the Cancel button to cancel the changes. 41

DEVICE SETUP To enable/disable overlap invasive pressure waveforms: 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Waveforms button to access the Setup Waveform Area dialogue. 3. Locate the Overlap Invasive Pressurelabel: a. Select Yes to overlap all available invasive pressure. b. The invasive pressures will occupy the space of four waveform slots. c. The overlapped invasive pressure have independent waveform sizes. d. Select No to keep the invasive pressure waveforms in separate waveform parameter tiles. 4. Select the OK button to enter that change OR select the Cancel button to cancel the changes. Recorder The Surveyor S12 and S19 patient monitors may have a two-channel thermal bedside recorder as a purchasable option. The Recorder dialogue provides configuration for which two waveforms print, the length of the recording strip, and the recording delay. Example Setup Recorder Dialogue To select the two waveforms to print on the bedside recorder (optional): 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Recorder button to access the Setup Recorder dialogue. 3. Locate the Waveform 1 (prints in top waveform position of the thermal recorder printout) label. 4. Locate the Waveform 2 (prints in the bottom waveform position of the thermal recorder printout) label. 5. Select the arrow to display the drop-down list box (Choices are dependent upon monitor configurations). 6. Select the waveformdesired. 7. Select the OK button to enter that change OR select the Cancel button to cancel the changes. To select the recording length to print on the bedside recorder (optional): 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Recorder button to access the Setup Recorder dialogue. 3. Locate the Recording Time label. 4. Select the arrow to display the drop-down list box (Choices are 5 seconds, 10 seconds, and 16 seconds). 5. Select the recording time desired. 6. Select the OK button to enter that change OR select the Cancel button to cancel the changes. 42

DEVICE SETUP To select the recording delay for the bedside recorder (optional): 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Recorder button to access the Setup Recorder dialogue. 3. Locate the Recording Delay label. 4. Select the arrow to display the drop-down list box (Choices are 0 seconds, 6 seconds, and 10 seconds). 5. Select the recording delay desired. 6. Select the OK button to enter that change OR select the Cancel button to cancel the changes. Arrhythmia Setup Arrhythmia Dialogue To adjust Arrhythmia alarm settings: 1. Select the Setup quick action key on the main screen. 2. Select the Arrhythmia button in the Setup menu. 3. Adjust the Arrhythmia alarm settings as desired. a. To adjust the Alarm Level: • Locate the Alarm Level button. • Select the arrow to display the drop-down list box with choices. • Select the appropriate choice. b. To adjust the Print on Alarm: • Locate the Print On Alarm button. • Select Yes to enable the Print On Alarm. c. Select No to disable the Print On Alarm. 4. Select the OK button to enter that change OR select the Cancel button to cancel the changes. VFib, Asystole and VTach may not be turned off in this dialogue, are only available as high level alarms, and are labeled as LETHAL. 43

DEVICE SETUP To disable all the non-lethal arrhythmias with one action: 1. Select the Setup quick action key on the main screen. 2. Select the Arrhythmia button in the Setup menu. 3. Select the Arrhythmia OFF button. 4. This action disables all the non-lethal arrhythmia alarms. 5. To re-enable a non-lethal arrhythmia, select the individual non-lethal arrhythmia and configure. Alarm Suspend The ability to suspend all alarms is a configurable feature determined by the system administration and is protected behind a password in the Administration Setup Alarms dialogue. Contact the system administrator for further details. WARNING: IF this feature is enabled, suspending all alarms suspends ALL alarm conditions including the lethal arrhythmias (VFib, VTach, and Asystole). Use this feature with extreme caution as alarm checking is suspended for all alarm conditions including the lethal arrhythmias (VFib, VTach, and Asystole). Patients must be closely observed if all alarms are suspended. NOTE: Follow hospital standard of care for the use of this feature. This feature is only intended to be used during end of life situations and only based on the hospital standard of care. NOTE: This feature can be enabled/disable by the system administrator. When this feature is enabled, during an Alarm Suspend mode, an Alarm Suspend message appears in the messaging area of the main screen. Once the Alarm Suspend period ends the audio and visual alarm notifications automatically resume. When this feature is enabled, to enter the All Alarms Suspended Mode and suspend all alarm notifications (including VFib, Vtach, and Asystole): 1. Select the Setup quick action key on the main screen. 2. Select the Alarm Suspend button in the Setup menu. • This displays the “Alarms Suspended” message in the message area on the main screen. • ALL alarms are now suspended including the lethal arrhythmias (VFib, Vtach, and Asystole). 3. Select the Close button to close the Setup menu. When this feature is enabled, to exit the All Alarms Suspended Mode and resume alarm notifications: 1. Select the Setup quick action key on the main screen. 2. Select the Alarm Resume button in the Setup menu. • This removes the “Alarms Suspended” message in the message area on the main screen. • All configured alarms are now active. 3. Select the Close button to close the Setup menu. Alarms The Setup Alarms dialogue is where the clinician can make changes to several parameters are one time as opposed to making changes through each individual numeric parameter’s tile. The Alarm section is pass code protected. The Pass code is: Dial 1 49 Dial 2 48 Dial 3 46 44

Example Setup Alarms Dialogue

DEVICE SETUP

To adjust numeric parameter alarm settings: 1. Select the Setup quick action key on the main screen. 2. Select the Alarms button in the Setup menu. 3. Locate the numeric parameter to adjust. Select the Next Page button to scroll to see more numeric parameters (based on monitor configuration). 4. Adjust the numeric alarm settings as desired. a. To adjust the Lower and High alarm limits: • Adjust the Lower alarm limit by selecting the up/down arrows to move the lower alarm limit box until the desired value is reached. • Adjust the Upper alarm limit by selecting the up/down arrows to move the upper alarm limit box until the desired value is reached. b. To Auto adjust the alarm limit values: • Select the Auto button. c. To adjust the Alarm On/Off: • Select Yes to enable that parameters’ alarms. • Select No to disable that parameters’alarms. • The Alarm Off icon displays in that numeric parameter tile. WARNING: Disabling the parameters’ alarm limits means that NO low or high alarm conditions for that parameter will produce alarm notifications. Use this feature with extreme caution. NOTE: The Lower Limit and Higher Limit windows in this dialogue may contain limit values but these alarms ARE disabled if that numeric parameters’ Alarms on button is set to NO. d. To adjust the Print on Alarm: • Locate the Print On Alarm button. • Select Yes to enable the Print On Alarm. • Select No to disable the Print On Alarm. 5. Select the OK button to enter that change OR select the Cancel button to cancel the changes. 45

Audio

DEVICE SETUP

The Setup Audio dialogue is where the speaker volume and the HR/PR tone volume are configured. This area is also where the HR/PR systole beep tone can be enabled and disabled.

Example Setup Audio Dialogue

To adjust the speaker volume: 1. Select the Setup quick action key on the main screen. 2. Select the Audio button in the Setup menu. 3. Locate the Speaker Volume label. 4. The Speaker Volume choices are 1 to 10 in increments of 1. a. Select the Up arrow to increase the speaker volume. b. Select the Down arrow to lower the speaker volume. c. As the volume is adjusted, an audible tone is played to indicate the volume of the speaker. 5. Select the OK button to enter that change OR select the Cancel button to cancel the changes. To adjust the HR/PR systole beep tone volume: 1. Select the Setup quick action key on the main screen. 2. Select the Audio button in the Setup menu. 3. Locate the HR/PR Tone Volume label. 4. The HR/PR Tone Volume choices are 1 to 10 in increments of1. a. Select the Up arrow to increase the HR/PR systole beep volume. b. Select the Down arrow to lower the HR/PR systole beep volume. c. As the volume is adjusted, an audible tone is played to indicate the volume of the HR/PR systole beep. 5. Select the OK button to enter that change OR select the Cancel button to cancel the changes. To enable/disable the HR/PR systole beep tone: 1. Select the Setup quick action key on the main screen. 2. Select the Audio button in the Setup menu. 3. Locate the HR/PR Tone label. a. Select Yes to enable the HR/PR systole beep tone. b. Select No to disable the HR/PR systole beep tone. 4. Select the OK button to enter that change OR select the Cancel button to cancel the changes. 46

Restore Departmental Defaults Restore Departmental Defaults

DEVICE SETUP

To restore the patient monitor back to the departmental default configuration: 1. Select the Setup quick action key on the main screen to access the Setup dialogue. 2. Select the Restore Departmental Defaults button. 3. Select the OK button to enter OR select the Cancel button to cancel the changes. Administration The Administration dialogue contains service and configuration related functions. The functions located on the left of this dialogue do not require a password. The functions located on the right of this dialogue are passwordprotected. Contact the system administration for further details. Example Administration Dialogue

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Configuration

DEVICE SETUP

Selecting this item displays the setup of this Surveyor including its serial number, Ethernet MAC address, internal software version as well as those of accessories and modules integrated with this system. There are no configuration options here but this information is helpful for service personnel when analyzing the system for issues.

Example Setup Configuration Dialogue

Communications

Use this dialogue to configure the communication parameters of the Surveyor including the Bed ID, Unit ID as well

as the network parameters for both the Surveyor Central and this Surveyor patient monitor. This information is

typically defined by authorized installation and service personnel.

The communications are pass code protected. The pass codeis:

Dial 1

53

Dial 2

51

Dial 3

54

Specific configuration parameters include: • Bed ID and Unit ID for interfacing with Surveyor Central. • TCP/IP network parameters including host name, IP address, and port number for Surveyor Central. • Whether dynamic host control protocol (DHCP) is utilized by the Surveyor to obtain IP address information for the bedside monitor. If not, the user can define specific static IP addresses including IP address, subnet mask, gateway address and Domain Name System (DNS) address information.

Example Setup Communications Dialogue

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