S12 and S19 Surveyor Patient Monitors Service Manual Rev G1

Copyright © 2016 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. V1.0 Mortara is a registered trademark of Mortara Instrument, Inc. Surveyor™, AM12M™, and VERITAS™ are trademarks of Mortara Instrument, Inc. Nellcor™, Covidien™, C-LOCK™, SatSeconds™, OxiMax™, MAX™, Max-Fast™, SoftCare™, Oxiband™, DuraY™, PediCheck™, OxiCliq™, and Durasensor™ are trademarks of Nellcor Puritan Bennett Inc. Smart Capnography™, Smart Breath Detection Algorithm™ (BDA™), Smart Alarm Respiratory Analysis ™ (SARA), Integrated Pulmonary Index™ (IPI), Microstream®, Filterline® and Capnoline® are trademarks or registered trademarks of Oridion Medical Ltd. Edwards® is a registered trademark of Edwards Lifesciences Corporation. Oridion CO2 License Information -- NO IMPLIED LICENSE – Possession or purchase of this bedside monitor does not convey any express or implied license to use the bedside monitor with unauthorized consumable 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.

TABLE OF CONTENTS

TABLE OF CONTENTS SERVICE MANUAL ... 1 1.

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

2.

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

3.

WARRANTYINFORMATION ...3 YOUR MORTARA WARRANTY ... 3

4.

USER SAFETY INFORMATION ...5 SAFETY REGULATIONS ... 5 POWER WARNINGS ... 6 ACCESSORIES, CABLES, AND EXTERNAL CONNECTIONS WARNINGS... 8 USE WITH ELECTRO SURGERY DEVICES WARNINGS... 9 INSTALLATION AND MOUNTING WARNINGS ... 9 ECG WARNINGS ... 9 ECG CALCULATED HEART RATE WARNINGS ... 10 WARNINGS FOR PATIENTS WITH PACEMAKERS ... 11 RESPIRATION WARNINGS... 11 SPO2 WARNINGS ... 11 NIBP WARNINGS ... 13 INVASIVE PRESSURE WARNINGS ... 14 CO2 WARNINGS ... 14 CARDIAC OUTPUT WARNINGS ... 14 NOTES ... 17

5.

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

6.

ELECTROMAGNETIC COMPATABILITY (EMC) ... 21 TABLE X-1 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS... 22 TABLE X-2 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 22 TABLE X-3 GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ... 23 TABLE X-4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT ... 24

7.

GENERAL CARE AND MAINTENANCE ... 25 PRECAUTIONS ... 25 INSPECTION ... 25 CLEANING ... 25 MAINTENANCE ... 28 BATTERY REPLACEMENT ... 30 BATTERY LIFE AND CHARGE TIME ... 30 BATTERY CONDITIONS... 31

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TABLE OF CONTENTS

DECOMMISSIONING AND DISPOSAL ... 31 CALIBRATION ... 31 CO2 CALIBRATION ... 31 INVASIVE PRESSURE CALIBRATION... 32 NIBP CALIBRATION ... 32 S12/S19 PREVENTATIVE MAINTENANCE RECORD ... 33 8.

DEVICESETUP ... 34 OVERVIEW ... 34 PATIENT INFORMATION ... 34 PARAMETERS ... 34 WAVEFORMS ... 35 RECORDER ... 37 ARRHYTHMIA ... 38 ALARM SUSPEND ... 39 ALARMS ... 39 AUDIO ... 41 RESTORE DEPARTMENTAL DEFAULTS... 42 ADMINISTRATION ... 42 CONFIGURATION ... 43 COMMUNICATIONS ... 43 SCREEN CLEANING ... 44 ADMINISTRATION SETUP ALARMS DIALOGUE ... 44 ADMINISTRATION SETUP SYSTEM DIALOGUE... 46 ADMINISTRATION SETUP SERVICE DIALOGUE ... 47 ADMINISTRATION SETUP FACTORY DIALOGUE ... 47

9.

UNIT DISSASSEMBLY ... 48 BATTERY REMOVAL & REPLACEMENT ... 51 REAR HOUSING REMOVAL & REPLACEMENT ... 52 PROCESSOR BOARD REMOVAL & REPLACEMENT ... 55 MAIN BOARD REMOVAL & REPLACEMENT ... 56 LCD REMOVAL & REPLACEMENT S12 ... 58 LCD REMOVAL & REPLACEMENT S19 ... 59 REMOVAL AND REPLACEMENT OF THE OPTIONAL THERMAL WRITER (S12 ONLY) ... 61 OPTIONAL THERMAL WRITER FOR THE S19... 64

10.

CONFORMANCE TESTING ... 75

REQUIRED EQUIPMENT: ... 75 1.0 POWER TESTING ... 76 2.0 FUNCTIONAL TESTING ... 76 3.0 DEVICE CLEANING ... 105 4.0 SAFETY TESTING... 105 11.

PRODUCT SPECIFICATIONS ... 107

GENERAL SPECIFICATIONS ... 107 ENVIRONMENTAL CONDITIONS ... 107 POWER REQUIREMENTS & BATTERY ... 107 DISPLAY SPECIFICATIONS ... 108 RECORDER SPECIFICATIONS ... 108 MOUNTING SPECIFICATIONS... 109 TRENDING ... 109 12.

PARAMETER SPECIFICATIONS ... 110

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TABLE OF CONTENTS

PATIENT POPULATION ... 110 WAVEFORMS ... 110 ECG ... 110 ARRHYTHMIA ANALYSIS ... 111 ST ANALYSIS ... 112 NON-INVASIVE BLOOD PRESSURE (NIBP) ... 113 PULSE OXIMETRY (SPO2) ... 113 TEMPERATURE ... 114 RESPIRATIONS: VIA ECG IMPEDANCE ... 114 CAPNOGRAPHY (CO2) ... 114 INVASIVE PRESSURES ... 115 CARDIAC OUTPUT ... 116 13.

PARAMETER ALARM LIMIT RANGES ... 118

ADULT PATIENT MODE ... 118 PEDIATRIC PATIENT MODE ... 120 14.

ALARM SPECIFICATIONS ... 122

GENERAL ALARMS ... 122 ECG AND HR MESSAGES ... 122 NON-INVASIVE BLOOD PRESSURE (NIBP) MESSAGES ... 123 PULSE OXIMETRY (SPO2) MESSAGES ... 125 TEMPERATURE MESSAGES ... 126 RESPIRATION MESSAGES ... 127 CAPNOGRAPHY (CO2) MESSAGES ... 128 INVASIVE PRESSURE MESSAGES ... 129 CARDIAC OUTPUT MESSAGES ... 130 15.

TROUBLESHOOTING ... 131

POWER AND BATTERY ... 131 DISPLAY AND TOUCH SCREEN ... 131 ECG, ARRHYTHMIA, AND ST ... 132 NON-INVASIVE BLOOD PRESSURE (NIBP) ... 132 PULSE OXIMETRY (SPO2) ... 133 TEMPERATURE ... 133 RESPIRATIONS: VIA ECG THORACIC IMPEDANCE ... 133 CAPNOGRAPHY (CO2) ... 133 INVASIVE PRESSURES ... 134 CARDIAC OUTPUT ... 134 16.

MOUNTING ACCESSORIES ... 138

QUICK DISCONNECT (M-SERIES) WALL MOUNTING COMPONENTS ... 138 VALUE (VESA M-SERIES) WALL MOUNTING COMPONENTS ... 138 PREMIUM (VHM-25) WALL MOUNT COMPONENTS... 139 SURVEYORS12 ROLLSTAND COMPONENTS (NOTTOBE USEDWITH S19) ... 140

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1. GENERAL STATEMENTS Technical Support and Service

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

European Union Representative Mortara Instrument Europe s.r.l. Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582

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

Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument Germany Bonifaciusring 15 45309 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel: +61 2 8070 9303 Fax: +61 2 9899 9478 Mortara Instrument UK Ltd Units 11 & 12, Scion House Stirling University Innovation Park Stirling FK9 4NF Scotland Tel: +44.1786.444980 Fax: +44.1786.446630

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2. NOTICES Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance of the patient monitor, as indicated by the

    

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

WARNING: System installation and assembly operations, extensions, readjustments,modifications or repairs are carried out by personnel authorized by Mortara Instrument, Inc. only. The patient monitor is used in accordance with the instructions for use. The patient monitor is correctly maintained according to the standards authorized by Mortara Instrument, Inc. using original spare parts. The patient monitor is used with original accessories and supplies that are in compliance with the standard specifications described in this manual. The electrical installation of the relevant room complies with the requirements of appropriate regulations.

Responsibility of the Customer The user of this patient monitor is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. This manual must be kept in a safe place to prevent its deterioration and/or alteration. The user and Mortara Instrument, Inc. authorized personnel must have access to this manual at any time. The user of this patient monitor must periodically check the accessories, their functionality and integrity. Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the patient monitor. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated into another language without prior written consent of Mortara Instrument, Inc. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.

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3. WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the number of years specified on documentation accompanying the product, or previously agreed to by the purchaser and Mortara, or if not otherwise noted, for a period of twelve (12) months from the date of shipment. Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date of first use, whichever is sooner. Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions: a) Freight damage; b) Supplies, accessories and internal parts NOT approved byMortara; c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides; d) Accident; e) A disaster affecting the Product/s; f) Alterations and/or modifications to the Product/s not authorized by Mortara; g) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions. THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence there from relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold.

3

WARRANTY INFORMATION

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

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4. USER SAFETY INFORMATION Warning:

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

Caution:

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

Note:

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

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

Surveyor is a medical patient monitor.



Surveyor 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).





This manual gives important information about the use and safety of this patient monitor. Deviating from operating procedures, misuse or misapplication of the patient monitor, or ignoring specifications and recommendations could result in increased risk of harm to users, patients and bystanders, or damage to the patient monitor.



Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient care, and adequately trained in the use of this patient monitor. Patient monitor captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis; however, the data should not be used as a sole means for determining a patient’s diagnosis.



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



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



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



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

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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.

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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 Mortara-provided external power adapter with the Surveyor. Ensure that the power adapter is connected to a properly grounded power terminal and the electrical installation complies with local safety requirements for the environment where it is used.



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

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Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be operated from its internal battery power source.

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Do not use the Surveyor power supply to power other devices, because of the risk of additional leakage currents

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USER SAFETY INFORMATION

and of transformer overload. 

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.

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

Do not immerse the device in water. Do not heat or throw the device in fire. Do not leave the in conditions over 60 ºC or in a heated car. Do not attempt to crush or drop the device. Only use the approved Mortara battery pack with the Surveyor monitor. Follow the instructions in the disposal section of this manual when the Surveyor monitor is taken out of service.

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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.

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The Surveyor produces audible startup tones when powered on (two tones followed by two higher beeps). If a patient monitor does not sound the startup tones when it is powered on, remove the patient monitor from service and contact Mortara Technical Support.

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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.

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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.

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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.

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USER SAFETY INFORMATION

Accessories, Cables, and External Connections Warnings 

The patient monitor is designed to meet applicable specifications when using Mortara-approved patient cables and accessories. Use of non-approved cables and accessories may result in reduced performance and may pose possible patient and user safety concerns.



It is the user’s responsibility to use only approved supplies, accessories and internal parts available through Mortara Instrument, Inc. Product performance and patient safety require the use of supplies, accessories and internal parts that comply with applicable standards. To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient contact must be in compliance with applicable standards including IEC 60601-1, or other IEC standards (e.g., IEC 60950) as appropriate to the patient monitor. Additionally, cables and accessories must comply with all EMC regulations. In Europe, cables and accessories should bear the CE Mark. Only use parts and accessories supplied with the patient monitor and available through Mortara Instrument, Inc.

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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.

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Proper clinical procedure must be employed to prep the electrode and sensor sites and to monitor the patient for excessive skin irritation, inflammation, or other adverse reactions. Electrodes and other sensors are intended for short-term use and should be removed from the patient promptly following testing.

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Conductive parts of the ECG patient cables, electrodes, and associated connections of type CF applied parts, including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground.

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To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with patient monitor or patient cables. Additionally, proper placement of defibrillator paddles in relation to the ECG electrodes is required to minimize harm to the patient.

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To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes, IBP catheters, disposable SpO2 sensors, disposable temperature sensors, single-use blood pressure cuffs, etc.) must not be reused.

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

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

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All accessories including hoses, cables, connectors, hoses and other patient-applied parts supplied with the Surveyor do NOT contain any Latex. If the patient develops an allergic reaction or rashes, immediately remove the accessory and inform Mortara Technical Support.

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

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

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

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USER SAFETY INFORMATION

Use with Electro Surgery Devices Warnings 

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

Installation and Mounting Warnings 

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

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

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Only approved rolling stands and wall-mount fixtures should be used with the Surveyor.

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

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

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The S19 should NOT be mounted on a rolling stand.

ECG Warnings 

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

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

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If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the lead(s) where this condition is present and if the signal is being displayed or printed, the respective lead(s) will print out as blank. A lead fail alarm is generated on the 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.

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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.

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

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USER SAFETY INFORMATION

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

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The system captures and presents data reflecting a patient’s physiological condition that when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis. The system is equipped with Mortara’s VERITAS™ 12-lead resting ECG interpretation algorithm. The VERITAS ECG algorithm can provide an over-reading physician with a silent second opinion through diagnostic statements output on the ECG report.



12-lead ECGs acquired through Surveyor will normally use a modified lead system with the limb electrodes positioned on the torso. Although this is a generally accepted practice (e.g., in stress testing), the different electrode positions can cause morphology changes on the ECG, thus influencing their interpretation. Most frequently seen differences are a vertical and rightward axis shift, minor changes of evidence of old inferior infarction and changes in the T-wave in the limb leads. All 12-lead ECGs printed with Surveyor have a warning message that alerts the physician that the ECG might have been acquired with torso positioned limb leads. It is recommended that you place the electrodes as close as possible to the normal limb positions avoiding the possibility of causing artifact. The right arm and left arm electrodes should be placed on the clavicles as close as possible to the arms. The left leg electrode should be placed as close as possible to the left leg without subjecting it to the possibility of motion artifact.

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During periods of lead fail and when a reduced lead set is used for patient monitoring, 12-lead resting ECG interpretation cannot be reliably used in determining a diagnosis.

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

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.

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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.

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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.

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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.

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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.

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Heart rate indication is not reliable during episodes of ventricular fibrillation.

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

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USER SAFETY INFORMATION

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

Mortara 99.94 99.87 95.49 97.05 0.220 AHA Database

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



Mortara 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.

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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.

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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.

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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.

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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.

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Use pulse oximetry sensors specified for the correct patient mode and for the correct application position.

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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.

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Tissue damage or inaccurate measurements may be caused by incorrect SpO2 sensor application or use, such as

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USER SAFETY INFORMATION

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.

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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.

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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 Severe vasoconstriction o Severe anemia o Hypothermia o Venous pulsations o Ventricular septal defects (VSDs) Sensor placement: o Incorrect sensor placement o Poor sensor fit

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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.

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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.

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SpO2 signal inadequacy is indicated by error messages or alarms generated at the Surveyor patient monitors.

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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.

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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.

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To prevent erroneous readings, do not use physically damaged sensors, cables or modules. Discard a damaged sensor or cable immediately.

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The performance of the pulse oximetry may be compromised by excessive motion including tremors or

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USER SAFETY INFORMATION

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 cuff’s to determine whether a particular cuff fits the patient’s arm or not.

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The Surveyor patient monitor is not intended for use with neonates.

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Do not fold, clamp, cut, or alter the pressure hose of the cuff or the monitor.

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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.

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Educate the patient to relax, rest, and lie still during inflation and pressure measurements. Patient movement can lead to artifacts or errors.

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The pressure measurement might be influenced by patient position, physical conditions, and other factors.

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Avoid placing the blood pressure cuff on the arm next to where a patient has had a mastectomy.

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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.

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There may be an increased risk of hematomas in patients with serious coagulation problems.

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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.

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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.

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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.

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USER SAFETY INFORMATION



NIBP measurements may be inaccurate in the presence of arrhythmias, motion artifacts, shivering, or trembling patients.



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.

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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.

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Route all tubing away from the patient’s throat to avoid strangulation.

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Do not apply pressurized air to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.

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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.

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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.

Cardiac Output Warnings 

Refer to the catheter package insert provided with each PA catheter for the appropriate computation constant, specific instructions on catheter placement and use, warnings, cautions, and specifications.



Inaccurate Cardiac Output measurements may be caused by: o Incorrect placement or position of the catheter.

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o o o o o o o o

USER SAFETY INFORMATION

Excessive variation in pulmonary artery blood temperature, perhaps caused by bolus drug administration. Clot formation on the thermistor port. Anatomical abnormalities, (for example, cardiac shunts). Excessive patient movement. Repeated intermittent flushes of cold fluid through the fluid lumens of the catheter. Electrocautery or electrosurgical device interference. Rapid changes in cardiac output. Using an incorrect computation constant.

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