ComboMap Model 6800 System Operators Manual Ver 1.9.x

ComboMap System

Table of Contents INTERNATIONAL SYMBOLS ... 5 INTRODUCTION ... 7 OVERVIEW ... 10 INTENDED USE ... 10 PRESSURE MEASUREMENTS ... 10 FLOW MEASUREMENTS... 10 GUIDE WIRES ... 10 CLINICAL APPLICATIONS ... 11 CONTRAINDICATIONS ... 11 POSSIBLE ADVERSE REACTIONS ... 11 SYSTEM COMPONENTS ... 12 TOUCHSCREEN MONITOR ... 12 REAR PANEL ... 12 HARD DRIVE ... 17 CD DRIVE ... 18 SPEAKERS... 18 INFRARED WINDOW ... 18 LABEL PRINTER ... 18 REMOTE CONTROL ... 20 CART ... 23 PATIENT INTERFACE MODULE ... 24 GUIDE WIRES ... 25 INTERFACE CABLES ... 25 PC SOFTWARE... 25 SYSTEM PREPARATIONS ... 26 SYSTEM POWER ... 26 PRINTER CONNECTIONS ... 26 PATIENT INTERFACE MODULE CONNECTION ... 26 INPUT CONNECTIONS ... 27 OUTPUT CONNECTIONS... 28 TURN SYSTEM ON ... 29 SYSTEM SETTINGS ... 30 PRESSURE SETTINGS ... 35 FLOW SETTINGS ... 38 PATIENT PARAMETERS ... 44 MEASUREMENTS... 49 AUTOMATIC WIRE CONFIGURATION ... 49 DISPLAY OPTIONS ... 49 PRESSURE MEASUREMENTS ... 50 FLOW MEASUREMENTS... 54 COMBINED PRESSURE/FLOW MEASUREMENTS ... 57 DISPLAY FREEZE/PAUSE ... 61

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DISPLAY PLAYBACK ... 62 SYSTEM SHUTDOWN ... 63 APPENDIX A: TROUBLESHOOTING ... 64 FREQUENTLY ASKED QUESTIONS ... 64 FIELD SERVICE CONTACT INFORMATION ... 66 MESSAGE ALERTS ... 66 ARCHIVING MESSAGES ... 68 ELECTRICAL INTERFERENCE ... 70 APPENDIX B: PHYSIOLOGICAL INFORMATION... 71 PRESSURE MEASUREMENTS AND CALCULATIONS ... 71 FLOW MEASUREMENTS AND CALCULATIONS ... 72 COMBINED PRESSURE & FLOW MEASUREMENTS AND CALCULATIONS ... 76 APPENDIX C: TECHNICAL SPECIFICATIONS ... 77 COMPUTER ... 77 REAR PANEL CONNECTIONS ... 77 PRINTER ... 78 CLASSIFICATIONS... 79 EMC STATEMENT ... 79 ELECTRICAL SAFETY ... 80 FLOWIRE DOPPLER GUIDE WIRE SPECIFICATIONS ... 80 AORTIC TRANSDUCER... 80 ALARA... 80 ENVIRONMENTAL CONDITIONS ... 83 MEASUREMENT ACCURACY ... 83 PACKAGING ... 83 STANDARDS AND REGULATIONS ... 84 APPENDIX D: SERVICE AND MAINTENANCE ... 86 MODEL NUMBERS ... 86 SERVICE ... 86 MAINTENANCE ... 86 DISPOSAL ... 87 APPENDIX E: DISCLOSURES ... 88

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International Symbols WARNING: This device is not intended for use with high frequency electrosurgical units.

WARNING: Before connecting to any device, refer to this Operator’s Manual.

WARNING: This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Attention: Read Operator’s Manual and Instructions For Use prior to using this device. For Manual in native language please contact your local Volcano representative. Type of equipment, Defibrillation Proof, the degree of protection against electrical shock as indicated by this symbol. ® Note: The CF rating of the BrightWire™ and FloWire Guide Wires and the Aortic Transducer input does not depend on the transducer type since the input ports are fully isolated and defibrillation proof. Note: The ComboMap System is protected against the effects of a discharge of a cardiac defibrillator; however, the BrightWire Pressure Guide Wire readings may be affected. Recalibrate the BrightWire Pressure Guide Wire after defibrillator use. Do no use the BrightWire Pressure Guide Wire for patient monitoring.

Canadian Standards Association. C22.2 No. 601.1-M90. Applicable for United States and Canada.

Complies with the 93/42/EEC Medical Device Directive concerning medical devices.

Keep dry

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Attention: observe precautions for handling electrostatic discharge sensitive devices.

Sterile (sterilized using ethylene oxide)

Serial Number

Shelf life

Do no reuse. Single use only.

Not to exceed temperatures

Percent relative humidity

Atmospheric pressure range for storage conditions

AC to DC power supply

Equipotentiality for grounding the ComboMap System to an equipotential ground

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Introduction Read and Review Manual before Operation Carefully read and review the entire Volcano Corporation ComboMap® 6800 System Operator’s Manual, as well as any manuals for installed options, before you attempt to operate the system. WARNINGS are used to indicate the possibility of severe personal injury. Follow the instruction or procedure correctly to avoid injury to yourself, the patient, or other personnel. CAUTIONS are used to indicate the possibility of damage to the equipment. Follow the instruction or procedure correctly to avoid damage to the equipment.

For Use only by Trained Medical Personnel Federal (USA) law restricts this device to sale by or on the order of a physician. Only physicians or other persons with adequate medical training in catheter insertion procedures should use the Volcano Corporation ComboMap System. Only those personnel who are familiar with its operation and who have been trained to perform the procedures for which this device is intended should use the system.

Precaution: Perform ultrasound procedures prudently using the principle of ALARA (As Low As Reasonably Achievable), as described in Appendix C.

Installation To ensure proper operation and warranty coverage, the ComboMap system must be installed and tested by following the Device Installation and Operational Qualification that accompanies each device.

Field Service Information The Volcano Corporation ComboMap System contains no user serviceable components. To avoid electric shock, do not remove any panels or covers. In the event of malfunction or system damage, turn the system off, unplug the system from the power receptacle, and contact a qualified service person and Volcano Corporation Field Service:

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Volcano Corporation 2870 Kilgore Road Rancho Cordova, CA 95670 USA Telephone: 800.228.4728 Fax: 916.638.8812 E-mail: [email protected] Authorized European Representative Volcano Europe SA/NV Excelsiorlaan 41 B-1930 Zaventem Belgium Telephone: +32 2 679 10 76 +800 8 VOLCANO (+800 8 865226) Fax: +32 2 679 10 79

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Warranty NOTICE: Manufacturer’s Specifications and Policies Subject to Change. Volcano Corporation reserves the right to make changes in the products described in this manual in order to improve design or performance. Reproduction or distribution of any portion of this manual without the prior written consent of Volcano Corporation is prohibited.

LIMITED WARRANTY Subject to the conditions and limitations on liability stated herein, Volcano Corporation (“VOLCANO”) warrants that the ComboMap System (the “System”) as so delivered shall materially conform to VOLCANO’s then current specifications for the System, for a period of one year from the date of delivery. ANY LIABILITY OF VOLCANO WITH RESPECT TO THE SYSTEM OR THE PERFORMANCE THEREOF UNDER ANY WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY WILL BE LIMITED EXCLUSIVELY TO SYSTEM REPAIR, REPLACEMENT OR, IF REPLACEMENT IS INADEQUATE AS A REMEDY OR, IN THE OPINION OF VOLCANO, IMPRACTICAL, TO REFUND OF THE PRICE PAID FOR THE SYSTEM. EXCEPT FOR THE FOREGOING, THE SYSTEM IS PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF FITNESS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. FURTHER, VOLCANO DOES NOT WARRANT, GUARANTEE, OR MAKE ANY REPRESENTATIONS REGARDING THE USE, OR THE RESULTS OF THE USE, OF THE SYSTEM OR WRITTEN MATERIALS IN TERMS OF CORRECTNESS,ACCURACY, RELIABILITY, OR OTHERWISE. Buyer understands that VOLCANO is not responsible for and will have no liability for any items or any services provided by any persons other than VOLCANO. VOLCANO shall have no liability for delays or failures beyond its reasonable control. Additionally, this warranty does not apply if: 1. The System is operated in other than a manner prescribed by VOLCANO in the Operator’s Manual, and/or supplements. 2. The System is operated in a manner that is not in conformance with purchase specifications and specifications contained in the Operator’s Manual, and/or supplements. 3. The System is not maintained in accordance with procedures in the Operator’s Manual, and/or supplements. 4. The System is repaired, altered, or modified in any way by other than VOLCANO’s authorized personnel, or without VOLCANO’s authorization. Contact VOLCANO Field Service for instructions and issuance of a Return Material Authorization if claims under this warranty become necessary and if the System or components of the System are to be returned. The System or components will not be accepted for warranty purposes unless the return has been authorized by VOLCANO. System parts or components repaired or replaced under warranty bear the same warranty expiration date as the original equipment. Consumable parts (data disks, batteries, among others) are warranted only against defects in materials and workmanship. System parts purchased outside the original warranty period are warranted for a period of 90 days, subject to all of the restrictions contained in this Limited Warranty. Use of unauthorized replacement parts may void the warranty. In all cases, VOLCANO will be the sole judge as to what constitutes warrantable damage.

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Overview Intended Use The ComboMap 6800 System measures intravascular blood pressure and/or blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. The ComboMap System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures. NOTE: See the label provided with the Volcano Corporation functional measurement guide wire for specific indications, contraindications, and possible adverse reactions.

Pressure Measurements Blood pressure measurements provide hemodynamic information that is useful for the diagnosis and treatment of diseased vessels. To measure intravascular blood pressure, a SmartWire®1 Pressure Guide Wire, PrimeWire™™ Pressure Guide Wire, or ComboWire® Pressure/Flow Guide Wire is connected to the ComboMap System. After the guide wire has been positioned in a patient, a transducer on the distal end of the guide wire receives pressure signals. Those signals are sent to the ComboMap System, which processes and displays them in waveforms and numerical values.

Flow Measurements Blood flow velocity measurements also provide hemodynamic information useful for vessel diagnosis and treatment. To measure blood flow velocity, a FloWire® Doppler Guide Wire or ComboWire Pressure/Flow Guide Wire is connected to the ComboMap System. With the guide wire positioned in the affected blood vessel, the tip-mounted transducer transmits and receives ultrasound signals. The ComboMap System processes these signals, calculates velocity based on the Doppler shift, and displays a spectral waveform as well as measured and other calculated parameters.

Guide Wires The SmartWire Pressure Guide Wire, PrimeWire Pressure Guide Wire , FloWire Doppler Guide Wire, and ComboWire Pressure/Flow Guide Wire have mechanical properties similar to other angioplasty guide wires. The guide wires are for single use only. Caution: Use only the SmartWire, PrimeWire, FloWire, or ComboWire Guide Wires with the Volcano Corporation’s ComboMap System.

1

10

SmartWire® Pressure Guide Wire is sold as BrightWire™ Intravasuclar Guide Wire in some countries.

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WARNING: Avoid conductive contact to the guide wires because patient safety could be degraded.

WARNING: The SmartWire, PrimeWire, FloWire, and ComboWire Guide Wires are not intended for fetal use.

Clinical Applications ƒ ƒ ƒ ƒ ƒ

Measure intravascular blood pressure Measure intravascular blood flow velocity Assess the success of interventional procedures with pre- and post-treatment hemodynamic evaluation Provide additional diagnostic information as an adjunct to or in combination with interventional therapies such as balloon angioplasty or atherectomy Measure blood pressure and flow velocity in the coronary and peripheral vasculature, including these arteries: iliac, femoral, popliteal, tibial, carotid, aortic, subclavian.

Contraindications Use of the ComboMap System is contraindicated wherever tissue or organ damage is a reasonable probability. The ComboMap System is not intended for fetal use.

Possible Adverse Reactions The use of the Volcano Corporation’s guide wires-or any percutaneous intravascular catheter-could result in adverse reactions, including, but not limited to: arterial dissection or occlusion; arterial perforation; embolus or spasm; myocardial infarction; serious arrhythmias; abrupt closure of peripheral vessels.

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System Components This manual provides operating instructions for ComboMap System from Volcano Corporation. The main components of the ComboMap System are shown in Figure 1.

Touchscreen Monitor Infrared window for remote control

CD drive

Patient Interface Module (PIM) Printer Remote control System Cart

Figure 1: The ComboMap System

Touchscreen Monitor The primary method for operating the ComboMap System is through the touchscreen monitor. The touchscreen can be used with bare hands, wet hands, gloved hands, or with a pointing device. Blue buttons, green buttons, and the tabs respond to touch input. Gray buttons are inactive and will not respond. The green buttons indicate the most likely button to be used for the screen under normal operating conditions.

Rear Panel The rear panel of the ComboMap System contains the electrical panel and the connector panel. The rear panel is shown in Figure 2. 12

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Figure 2: ComboMap System Rear Electrical and Connector Panel Caution: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the Volcano Corporation Service Department.

WARNING: Do not remove the cover on the left side of the rear connector panel. There are no user-serviceable parts under the cover.

A/C Power Input Connector The female end of the cable is connected to the power input while the plug end is connected to A/C power using a hospital-grade outlet in the cath lab. Caution: The power cord used with the ComboMap System must be supplied by Volcano Corporation or an authorized distributor to ensure compliance with local safety standards.

Caution: For use in North America, all power cords must be marked “Hospital Grade” and must be connected to an equivalent receptacle marked “Hospital Grade” or “Hospital Only.”

Caution: When the ComboMap System is connected to a 240-volt supply system in the United States, the circuit must be a center-tapped, singlephase supply circuit. An enlargement of the connector panel of Figure 2 is shown below to use as reference in the following discussion.

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Power The power switch turns on power to the ComboMap System. NOTE: To turn off the ComboMap System, you should always use the Shutdown button on the bottom left of the screen instead of turning off the power switch or unplugging the system.

Display This rocker switch optimizes screen appearance by changing the brightness of the display in gradual increments. Hold the button down to make subtle changes to the display brightness.

Ground Referenced Ports WARNING: Because most of the rear panel ports are ground referenced, do not touch any of the ground referenced ports while simultaneously touching the patient. The following ports are exempt from this warning because they are isolated and defibrillation proof: Aortic Transducer, Aortic Out, and Distal Out. These isolated ports are marked with either an Attention symbol or a Defibrillation Proof symbol. Refer to pages 7 and 8 for a list of the symbols used on the ComboMap System.

Aortic Transducer You may connect a standard external pressure transducer to the ComboMap System to provide a low-level aortic pressure input. This is required when the hemodynamic system does not have a high-level pressure output or simultaneous ECG and pressure outputs for

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use with ComboWire. Aortic blood pressure measurements are required for the Pa-Pd, Pd/Pa, HSR, HMR, and FFR calculations. NOTE: This is a low-level connection with a standard sensitivity of 5µV/V/mmHg. The port is isolated and protected against cardiac defibrillators. This is a Type CF input.

NOTE: The Aortic Abbott Transpac and Namic Transducers are available from Volcano Corporation by contacting the Customer Service Department.

WARNING: When using an external transducer connected to the ComboMap System, take care to prevent small bubbles and entrapped air within the transducer and connecting tubing. Completely flush the transducer/ connecting tube assembly before connecting it to the patient.

NOTE: While holding the transducer assembly vertically, flush and gently tap the transducer housing to remove all air and bubbles.

WARNING: External pressure transducers are single-use devices only. They cannot be re-sterilized or reused.

Low-level Outputs The ComboMap System has two low-level outputs: Aortic Out and Distal Out. The ComboMap System low-level outputs comply with all applicable requirements of the IEC 60601-1 with Amendments 1 & 2, C22.2 No. 601.1-M90, and UL std. No. 60601-1, IEC 60601-2-34,2 1st edition. WARNING: These standards are met when the ComboMap System is connected to an approved isolated designated pressure port/channel of the cath lab monitoring equipment. The isolated pressure port to which the ComboMap System is connected must meet the following criteria in order for the ComboMap System to comply with the listed standards: Leakage current, isolated patient connections

< 10µA at 100-240VAC, 47-63 Hz

Monitor type

Must be type CF Defibrillation Proof

2

The ComboMap System does not comply with Clause 51.102.1 since the guide wire’s pressure transducer can drift over extended periods of time. It is important that the wire’s reading be verified every 10 minutes and normalized to the aortic reading if drift has occurred. The ComboMap System is not intended for long-term (hours) invasive pressure monitoring but rather is a diagnostic instrument for measuring pressure during catheterization procedures.

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Dielectric withstand, isolated patient connections

>4000VAC, 60 Hz, 1 minute

Dielectric withstand, non-isolated, nonpatient applied parts

≥1500 VAC, 60 Hz, 1 minute

Defibrillation recover time

Accuracy is within 20% in ≤ 5 seconds. Typical: 100% accuracy after 4 seconds.

Aortic Out This is a low-level (5µV/V/mmHg) output of the signal from the low-level aortic pressure transducer; it can also be the high-level signal output from the external physiology monitor if the software is configured for it. This output is intended to connect to an instrument that expects an actual transducer with a sensitivity of 5µV/V/mmHg. NOTE: The port is isolated and will not ground reference any external patient connections that are referenced to it. It is also protected against cardiac defibrillators.

Distal Out This is a low-level (5µV/V/mmHg) output of the distal pressure measured by the guide wire pressure transducer. This output is intended to connect to an instrument that expects an actual transducer with a sensitivity of 5µV/V/mmHg. NOTE: The port is isolated and will not ground reference any external patient connections that are referenced to it. It is also protected against cardiac defibrillators.

Ground Stud The ground stud is available for grounding the ComboMap System to an equipotential ground and is labeled with the equipotentiality symbol. The ground stud is the same ground as the third prong of the power connection, which grounds the entire unit. Depending on the ground scheme of the interfaced physiology equipment, tying the ground stud to the frame ground of the physiology equipment may provide an extra level of caution (although it is usually not necessary if both outlets use a three-prong configuration).

24 VDC Power Out This provides power to the printer through the included cable.

APV/Q This is a high-level output of Average Peak Velocity (APV), unless you have configured the output to be the raw Quadrature (Q) Doppler signal in the Research Settings screen. The actual output voltage depends on the scale factor you select in the Flow Settings screen.

IPV/I This is a high-level output of Instantaneous Peak Velocity (IPV) , unless you have configured the output to be the raw In-phase (I) Doppler signal in the Research Settings

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screen. The actual output voltage depends on the scale factor you select in the Flow Settings screen.

Aortic/Aux 1 Out This is the high-level (1 volt/100 mmHg) output of the aortic pressure reading from the external pressure transducer. If you have configured an Aux 1 input on the Research Settings screen, this output will be the high-level Aux 1 output.

Distal/Aux 2 Out This is the high-level (1 volt/100 mmHg) output of the distal pressure as measured by the guide wire pressure transducer. If you have configured an Aux 2 input on the Research Settings screen, this output will be the high-level Aux 2 output.

USB Ports There are two USB ports on the rear connector panel. The printer interface cable connects to one of the USB ports. You can use the other port for saving screen captures to a memory stick device. NOTE: Do not remove the memory stick device while the ComboMap System is powered. Shutdown before removing the memory stick device to ensure data on the memory stick is not corrupted.

ECG In The ComboMap System can receive and process the patient’s ECG signal to display it as a scrolling waveform on the monitor. ECG input is required to gate the flow data for accurate CFR measurements. Connect the ECG output from the physiology monitor to the ECG in connector. This high-level input has a range of ± 2.5 volts maximum. WARNING: Any device that connects to the ECG input port must have defibrillation protection.

Aortic/Aux 1 In This is a high-level (± 5 volts maximum), ¼-inch phone jack input for aortic pressure, coming in from a physiology monitor. Aortic blood pressure measurements are required for the Pa-Pd, Pd/Pa, HSR, HMR, and FFR calculations. This input can also be configured as an Aux 1 input on the Research Settings screen.

Venous/Aux 2 In This is a high-level (± 5 volts maximum), ¼-inch phone jack input for mean central venous pressure. Set the Venous Input of the Pressure Settings tab to External to read this port. This input can also be configured as an Aux 2 input on the Research Settings screen.

Hard Drive The ComboMap System hard drive can contain at least 49 hours of study file recordings. A study file recording requires approximately 6.4 MB/minute. To ensure a study file can be recorded on a single CD, the maximum study file duration is 90 minutes.

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CD Drive The ComboMap System has a CD drive for archiving patient files recorded to the internal hard drive. The patient studies are stored in proprietary file format. The ComboMap System pcFM (Model 6830) option is available for reading, analyzing, and exporting study files. NOTE: Volcano Corporation recommends the use of CD-R disks for the ComboMap System’s CD-RW drive rather than CD-RW disks due to the greater reliability of the CDR disks.

Speakers The ComboMap System has two speakers for stereo Doppler output. One speaker is for forward flow, the other for reverse flow. The Flow Setup screen allows you to adjust speaker balance and volume. NOTE: The sound direction does not change on the speakers if you change the flow direction between Antegrade and Retrograde.

Infrared Window The infrared window that responds to the remote control operation is located under the monitor of the ComboMap System.

Label Printer The ComboMap System has a thermal label printer so you can document waveforms, charts, and data onto specially treated, adhesive-backed labels without toner or ink cartridges. This printer model is specifically approved to work with power supplied by the ComboMap System 24 VDC power port using the power cable included in the installation kit. The ComboMap System cart has a shelf to hold the label printer. Figure 3 is an illustration of the printer.

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Figure 3: Printer The Playback tab has a Print button to initiate printing at anytime. The Live tab has the Print button available when the screen is frozen. You can also press the Print button on the remote control. An example of a printed label is shown in Figure 4.

Figure 4: Printed Label Press the button on the printer to feed blank paper through the printer. A flashing light indicates the labels are not loaded in the printer. To perform a printer self-test, press and hold the button for ten seconds.

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Labels Use only DYMO® brand refill labels with the ComboMap System printer; third-party substitute labels may have different sensitivity and thus may not print as clearly. Do not leave the labels in direct sunlight or exposed to fluorescent light for an extended period of time because this may cause fading. Do not let the labels come in contact with plasticizers (such as plastic ring binders) because this may cause fading.

Remote Control Besides operating the ComboMap System from the touch screen interface, you can use the remote control that comes with the system to control many of the functions. To use the remote control, point the front end of the device towards the infrared window on the front of the ComboMap System, under the touch screen. The remote has single function buttons to allow you to navigate directly to the specified control. You can also use the remote control’s right and left arrow keys to move to the function on the display that you want to control. Remember that the function is active when a yellow border surrounds the button on the monitor; the white cursor arrow on the display also points to the active button. The remote cannot control buttons on pop-up windows (identifiable by a gray background). The touch screen must be used to control functions on the pop-up windows. When you are at a function that has adjustable values, you can change the value in one of two ways: Select the value of the function (make sure the yellow border in the display is on the box containing the numeric value) and use the + or – keys to step through the available options for that function or to increase or decrease the parameter’s value. Alternately, you can select the up or down arrow key associated with the function (make sure the yellow border is on the button’s up arrow key, for example, if you want to increase the value) and press Enter until the selected value is displayed. The remote control has an auto-repeat mode when you change a parameter’s value in either of the ways described above. When you use the up or down arrow key on the remote control to change the value of the parameter within the yellow border, you can hold the key down to generate repeated increments or decrements of the value instead of having to press the key repeatedly to change the value. When you select the up or down arrow key of the associated parameter on the screen and press Enter to increase or decrease the value, holding the Enter key down will generate repeated increments or decrements of that function’s value. The remote control is shown in Figure 5, and the functions of each button are shown in Figure 6.

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Figure 5: Remote Control The remote control requires two 1.5-volt AAA batteries. To replace the batteries, slide the remote control cover open. Remove the old batteries and insert the new ones, matching the + marking on the batteries with the + marking on the enclosure. You can expect at least six months of normal usage from fresh batteries. Caution: If you will not use the remote control for an extended time, remove the batteries. Dispose of old batteries properly.

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