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Related Manuals for ZELTIQ CoolSculpting Elite
Summary of Contents for ZELTIQ CoolSculpting Elite
- Page 1 User Manual CoolSculpting® Elite System ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 USA www.coolsculpting.com ZELTIQ Customer Service Worldwide: (+1) 925-474-8160 USA: (+1) 888-935-8471 (1-888-ZELTIQ1) CS-UM-CM3-02-EN-D...
- Page 2 Copyright© 2020 ZELTIQ Aesthetics, Inc. All rights reserved. Unauthorized duplication or use is prohibited. COOLSCULPTING®, ZELTIQ®, and FREEZE DETECT® are registered trademarks of ZELTIQ Aesthetics, Inc. The procedures described in this document are covered by U.S. Patent 7,367,341. Additional issued patents and patent applications pending worldwide relate to the products and procedures described in this document.
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Page 3: Table Of Contents
CoolSculpting® Elite System User Manual Table of Contents Customer Service ......................5 Foreword ........................6 Indications for Use..........................6 Contraindications........................... 7 Warnings ............................... 7 Precautions ............................10 Adverse Events ........................... 10 Freeze Detect System ......................... 12 User Documentation..........................12 ....................................13 System Overview ...................... - Page 4 Cleaning .............................. 46 Maintenance ............................47 A P P E N D I X A .................................... 48 ZELTIQ Clinical Studies ....................48 A P P E N D I X B .................................... 61 System Symbols ......................61 A P P E N D I X C .................................... 66 System Specifications ....................
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Page 5: Customer Service
CoolSculpting® Elite System User Manual Customer Service To report issues with the performance or use of your System, contact ZELTIQ Customer Service: • Worldwide: (+1) 925-474-8160 • U.S.A.: 1-888-935-8471 (1-888-ZELTIQ1) • Email: CoolSculpting.support@allergan.com Routine Issues For questions regarding device performance or to report issues that do not interfere with current patient... -
Page 6: Foreword
CoolSculpting® Elite System User Manual Foreword The CoolSculpting® Elite System is a skin cooling or heating device. The system comprises of a control unit, applicators, and supplies such as cards, gelpads, pretreatment skin wipes, liners, foam borders, and comfort straps. The applicators, gelpads, pretreatment skin wipes, liners, foam borders, and comfort straps are patient-applied parts. -
Page 7: Contraindications
• Can be used to provide temporary relief of minor aches, pains, and muscle spasms. • The ZELTIQ Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device with a patient’s skin by mitigating minor variances in device-to-skin contact. - Page 8 Foreword CoolSculpting® Elite System User Manual The effect of performing a CoolSculpting® Elite treatment with a vacuum applicator on a patient who has a hernia in or adjacent to the treatment site has not been studied. The applicator uses vacuum pressure to draw tissue into the applicator cup during the treatment. The vacuum pressure may therefore apply pressure on a pre-existing hernia or pre-existing structurally weak area such as a surgical scar, causing further complications.
- Page 9 CoolSculpting® Elite System User Manual Foreword Table 2: Warnings for Specific Treatment Sites Treatment Site Warning Submental and Cold exposure to the hypoglossal submandibular areas nerve may cause tongue deviation following treatment of the submental and submandibular areas. Hypoglossal nerve Cold exposure to the marginal mandibular nerve may cause lower lip weakness following treatment of...
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Page 10: Precautions
If the operator observes a potential safety issue or operational abnormality during use, the operator should stop the treatment immediately and contact ZELTIQ Customer Service (see page 5). The use of other equipment and supplies with the system has not been tested and may cause unexpected results. - Page 11 CoolSculpting® Elite System User Manual Foreword Table 4: Rare Adverse Events Rare Event Description Paradoxical hyperplasia Visibly enlarged tissue volume within the treatment area, which may develop two to five months after treatment. Surgical intervention may be required. Late-onset pain Late-onset pain may begin several days after a treatment and usually resolves within several weeks.
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Page 12: Freeze Detect System
Note: ZELTIQ reserves the right to modify the content of the user documentation at any time. Retain the most current user documentation and always review it prior to using any component of the system. -
Page 13: System Overview
CoolSculpting® Elite System User Manual System Overview This chapter describes the control unit, the applicators, and supplies such as Card, Gelpad, Gel Trap, Pretreatment Skin Wipe (Skin Wipe), and Comfort Strap. Control Unit The control unit (Figure 1) is a portable device that is used to start, stop, and monitor treatments. Figure 1: Control Unit A: Touchscreen display B: Card slot... - Page 14 System Overview CoolSculpting® Elite System User Manual Touchscreen Display The touchscreen displays system controls, information about the status of the system, information about the treatment, and messages for the operator. You can rotate or tilt the display to accommodate better access. Card Slot The card slot accepts treatment cards.
- Page 15 USB port: The USB port (rectangular) is intended for use with approved software and hardware • provided by ZELTIQ. Chiller tank cap: The cap is for covering the coolant tank. A service technician is required to add coolant to the system. Please contact customer service.
- Page 16 System Overview CoolSculpting® Elite System User Manual Power Cord Clamp The power cord clamp attaches the power cord to the rear of the control unit, and it acts as a strain relief to protect the Power Receptacle if the cord is pulled. Install the power cord clamp before using the system.
- Page 17 CoolSculpting® Elite System User Manual System Overview Soft Power Button The display includes a soft power button at the lower right corner, which is used to power on the system, after turning the power switch on the rear of the system to the “On” position. The soft power button may also be used to power off the system.
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Page 18: Applicators
(Table 6). Clinicians should consider all physical aspects of the area to be treated and use the applicator that will fit best for each patient. ZELTIQ defines a specific combination of treatment temperature and duration for each profile. Typically, a colder treatment temperature is paired with a shorter treatment duration. - Page 19 CoolSculpting® Elite System User Manual System Overview CoolSculpting Curve 240 Large areas Down Up to Skin wipe Manual (C240™) with pinchable massage fat, such as -15°C minutes the flanks and abdomen CoolSculpting Flat 125 Vertical bulges Down Up to Skin wipe Manual massage (F125™)
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Page 20: Supplies
System Overview CoolSculpting® Elite System User Manual As soon as a treatment begins, the status changes to “Treating” and the system begins counting down from the total scheduled time. The remaining time is displayed in large numbers within a “clock” graphic. - Page 21 CoolSculpting® Elite System User Manual System Overview Table 7: Supplies Item Description Card Provides treatments and profiles for use with the system: • Profiles define the number of timed segments of cooling and heating. • For the Solo card, each cycle provides a single treatment for one applicator. •...
- Page 22 System Overview CoolSculpting® Elite System User Manual Item Description Comfort Strap Minimizes movement of the applicator during treatment. 1. Place bonnet on applicator. a. Insert applicator in bonnet. b. Secure bonnet over applicator. Zip the backside of the bonnet. 2. Position Comfort Strap. 3.
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Page 23: Treatment
CoolSculpting® Elite System User Manual Treatment Treatment A treatment is composed of timed segments of cooling and heating. Each treatment is based on a profile, which is contained on the card. Profiles, Treatments, and Cards The profile defines the temperature and duration of a treatment. Table 8 lists the elements that comprise a treatment profile. -
Page 24: Set Up The System
Treatment CoolSculpting® Elite System User Manual 2. Set up the system Materials required: • Treatment Card • Applicator(s) a. Power on the control unit and wait for the touchscreen to display the “Insert Card” prompt. b. Insert card into the slot on the control unit and wait a moment while the card authenticates. Screen should display “Reading Card.”... -
Page 25: Allē Loyalty Program
CoolSculpting® Elite System User Manual Treatment Note: If the system displays an error associated with the card (for example, an expired or incompatible card), find the message code in Table 11 and follow the recommended actions. c. When the system detects that the card is authenticated, tap OK. The next prompt is “Attach Applicator A or B.”... -
Page 26: Select Treatment Area
Treatment CoolSculpting® Elite System User Manual 4. Select Treatment Area On the Select Treatment Area screen, select the appropriate treatment area by tapping the location on the body. The desired treatment area highlights bright yellow and remains highlighted. Note: For cleared indications for use, contraindications, and warnings, see “Foreword.” For warnings related to specific treatment sites, see Table 2. -
Page 27: Prepare The Patient
CoolSculpting® Elite System User Manual Treatment Example: Insert Gel trap on the back side of Applicator A Example: Insert Gel trap in metal plate in front of Applicator A (C80) b. Return to the touchscreen and tap Next. The next screen instructs to apply gelpad. 6. -
Page 28: Turn On Vacuum Using Single Applicator (I.e. Vacuum Or Surface Applicator)
Treatment CoolSculpting® Elite System User Manual Clean the treatment site with an alcohol wipe. Clean the treatment site with a pretreatment skin wipe for 60 seconds. a. Open a gelpad pack and remove the gelpad. Note: Gently grasp two corners on a long side of the gelpad and lift it off the package horizontally. - Page 29 CoolSculpting® Elite System User Manual Treatment The vacuum applicator draws tissue into the applicator cup and holds the tissue against the cooling surfaces of the applicator. Place the applicator over the center of the treatment site. iii. Inspect the gelpad and applicator to ensure that the gelpad extends beyond the borders of the applicator.
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Page 30: Start Treatment
Treatment CoolSculpting® Elite System User Manual 8. Start Treatment Note: If simultaneous treatment is desired, proceed “To perform a simultaneous treatment” step below. a. The next screen prompts to start treatment. After confirming that the gelpad and applicator are positioned correctly, treatment can be started. b. -
Page 31: End The Treatment
CoolSculpting® Elite System User Manual Treatment Example: Treatment for Applicator B b. Go to “Prepare the applicator” and repeat the procedure for Applicator B. Example: Starting Dual treatment for Applicators A and B c. If the treatment times for both the applicators is same, tap A for starting Applicator A first or B for starting Applicator B first. - Page 32 Treatment CoolSculpting® Elite System User Manual • Optional: Gauze soaked in isopropyl alcohol or equivalent wipes a. Place a towel or other absorbent material into the bucket on top of the control unit. b. Grasp the applicator to hold it in position; then tap the OFF button on the touchscreen to toggle the vacuum from ON to OFF.
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Page 33: Clean The Applicator
CoolSculpting® Elite System User Manual Treatment 10. Clean the applicator Materials required: • Cotton towel • Water-based wipe or wet gauze • Gauze soaked in isopropyl alcohol or equivalent wipes The electronic sensors on the cooling surfaces of the applicator are delicate and may be damaged by excessive pressure or unapproved cleaners. -
Page 34: Canceling A Treatment
Treatment CoolSculpting® Elite System User Manual Example: Start another treatment ► To perform another treatment on the same patient: a. At the touchscreen, tap Same Patient. The Select Treatment Area screen displays. b. Go to “Setup the system” and repeat the procedure from that point. ►... - Page 35 CoolSculpting® Elite System User Manual Treatment b. On the confirmation dialog, tap Stop. The confirmation dialog closes, and the system stops cooling. The treatment clock stops at its current time and displays “CANCELED.” The prompt displays the message “Operator canceled treatment.”...
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Page 36: Treatment Stopped By System
Treatment CoolSculpting® Elite System User Manual Treatment Stopped by System If the system detects a condition that requires operator intervention, the system stops the treatment. The treatment clock stops at its current time and displays “STOPPED.” An error message identifies the problem and provides guidance, including an error code. -
Page 37: System Tools
CoolSculpting® Elite System User Manual System Tools System tools include performance logs, diagnostics, and system settings. Controls for System Tools The Tools button provides access to system tools. The Tools button is available in the upper right corner of the screen. Table 9 lists controls related to system tools. ►... -
Page 38: System And Card Log Screens
The time that the event occurred in HH:MM format, where HH = hours and MM = minutes (for example, 12:02 PM) Code The ZELTIQ error code and the Customer Service code in format Z###-### Text The text of the control unit message ►... -
Page 39: Service Screens
CoolSculpting® Elite System User Manual System Tools Service Screens The Service screens allow diagnostics of the vacuum system and the chiller system. Also the service screen allows access to the modem. Example: Service buttons Vacuum ► To view the Vacuum screen: Note: Call Customer Service (page 5) for both chiller and vacuum issues due to available standards for testing. -
Page 40: Settings Menu
System Tools CoolSculpting® Elite System User Manual Modem ► To view the Modem screen: 1. From the Tools menu, tap the Service button. The Service menu appears under the Tools menu. 2. From the Service menu, tap the Modem button. The Modem screen appears. 3. - Page 41 CoolSculpting® Elite System User Manual System Tools 5. Return to the Tools menu or exit the Tools session: a. Tap the Back button to return to the Tools menu. b. Tap the Close button to exit the Tools session and return to the treatment session. Time Zone The Time Zone selects the system’s time zone.
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Page 42: About
System Tools CoolSculpting® Elite System User Manual Language The Language screen allows you to set the system’s language. ► To set the language: 1. From the Tools menu, tap the Settings button. The Settings menu appears under the Tools menu. 2. -
Page 43: System Messages
System Notification Text: See Table 15 • The system messages include a ZELTIQ code and a Customer Service code. These codes are written together using the format Z###-YYY, where: Z### is the ZELTIQ code (Z followed by a three-digit number) •... - Page 44 System Messages CoolSculpting® Elite System User Manual ZELTIQ Code Message text Action Z409 Remove the applicator and gelpad. Thermal event detected. Z409-YYY Do not retreat for at least 24 hours. Remove the applicator and gelpad. Refer to the User Manual.
- Page 45 CoolSculpting® Elite System User Manual System Messages Table 13: Error Messages: System ZELTIQ Code Message text Action For all error messages: • If a system error occurs, treatment Z801 Chiller error. Z801-YYY automatically stops. Contact Customer Service. • Power the control unit off and on.
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Page 46: Cleaning And Maintenance
CoolSculpting® Elite System User Manual Cleaning and Maintenance Perform routine cleaning and maintenance according to your site’s protocols. Cleaning The use of an unapproved cleaning solution or method on the control unit or applicator may result in damage. Always use approved products and follow the guidelines below. Approved Products The following products are approved for cleaning the control unit and applicators: Isopropyl alcohol... -
Page 47: Maintenance
CoolSculpting® Elite System User Manual Cleaning and Maintenance ► To clean the touch screen: 1. Dampen a soft lint-free cloth with isopropyl alcohol or window cleaning fluid. 2. Wipe the touch screen gently. Cleaning the Bucket Approved cleaning products include: •... -
Page 48: Zeltiq Clinical Studies
The ZELTIQ CoolSculpting System has undergone pre-clinical and clinical investigation (data on file at ZELTIQ). The clinical investigation and results pertaining to skin cooling for fat layer reduction in submental and submandibular areas, abdomen, flanks, thighs, and alternate treatment parameters are summarized in this section. - Page 49 CoolSculpting® Elite System User Manual ZELTIQ Clinical Studies Table 17: Treatment Efficacy and Safety Assessments Prior to Day 0 Assessment Day 0 Treatment 1 week 2 months 6 months Consent screening Baseline demographics Phone follow-up Photographs ...
- Page 50 ZELTIQ Clinical Studies CoolSculpting® Elite System User Manual Table 19: Independent Photo Review Results Treatment Number of All Data All Data Group Subjects % Correct ± % SE p-values All Groups 88.6 ± 4.1 < 0.001* Group 1 90.7 ± 5.1 <...
- Page 51 II to IV. No change in skin pigmentation was observed following a treatment. Based on the clinical data, ZELTIQ recommends that practitioners read this Preface carefully and pay special attention to warnings and cautions throughout the User Manual and Instructions for Use.
- Page 52 16-week follow-up. This is an adverse event that typically resolves spontaneously. The clinical investigations demonstrate that use of the ZELTIQ CoolSculpting System can safely and effectively induce cold-assisted lipolysis in the thigh in the same manner as in the abdomen and flanks.
- Page 53 -15°C for shorter duration treatments with vacuum and surface applicators. Submental Area Study ZELTIQ conducted a clinical investigation to determine the safety and efficacy of the CoolSculpting System for affecting the appearance of visibly localized subcutaneous fat localized in the submental area.
- Page 54 -10°C for 60 minutes. Summary of Upper Arm Study ZELTIQ conducted a clinical investigation to evaluate the safety and efficacy of cryolipolysis for non- invasive reduction of upper-arm fat.
- Page 55 CoolSculpting® Elite System User Manual ZELTIQ Clinical Studies This retrospective study started with the ZA14-002 per-protocol population (n=58) for analysis, excluded one subject due to excessive hair in the submental region, and used the remaining fifty-seven (57) subjects for analysis. Lateral photographic views of the face taken at baseline and at the 12-week post-final treatment visit were included in the analysis.
- Page 56 ZELTIQ Clinical Studies CoolSculpting® Elite System User Manual site specificity. The clinical publications indicate that cryolipolysis is a safe and effective non-surgical procedure for subcutaneous fat reduction. Summary of Clinical Study Publications for the Submental and Submandibular Areas Six clinical publications reported safety and effectiveness of 228 cryolipolysis treatments in 102 patients to include 89 patients with a Body Mass Index (BMI) of up to 46.2 and 27 patients treated in the...
- Page 57 CoolSculpting® Elite System User Manual ZELTIQ Clinical Studies Table 20: Applicator Placement Methods Treatment Reference Treatment Area Placement of the Applicator Cycles (n) Bernstein & Bloom, Submental and Bilateral treatment cycles with 20% overlap 2017 submandibular in the center of the submental area.
- Page 58 ZELTIQ Clinical Studies CoolSculpting® Elite System User Manual Kilmer SL, Burns AJ, Zelickson BD. Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat. Lasers Surg Med. 2015 Nov 26. Seaman SA, Tannan SC, Cao Y, Peirce SM, Gampper TJ. Paradoxical Adipose Hyperplasia and Cellular Effects after Cryolipolysis: A Case Report.
- Page 59 CoolSculpting® Elite System User Manual ZELTIQ Clinical Studies 23. Boey GE, Wasilenchuk JL. Enhanced Clinical Outcome with Manual Massage Following Cryolipolysis Treatment: A 4-Month Study of Safety and Efficacy. Lasers Surg Med. 2014 Jan; 46(1):20-6. 24. Stevens WG, Pietrzak LK, Spring MA. Broad Overview of a Clinical and Commercial Experience with CoolSculpting.
- Page 60 ZELTIQ Clinical Studies CoolSculpting® Elite System User Manual Burns JA, Allison J, Bachelor E, Dover J, Coleman S, Fitzpatrick R, Garden J, Geronemus R, Goldberg D, Kilmer S, Kramer S, Levinson M, Mayoral F, Okamoto E, Tanzi E, Riopelle J, Weiss R, Zelickson B.
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Page 61: System Symbols
CoolSculpting® Elite System User Manual System Symbols A P P E N D I X B System Symbols The following symbols are used on the components of the system and on its supplies and packaging. Table 21: System Symbols STANDARD SYMBOL SYMBOL STANDARD TITLE... - Page 62 System Symbols CoolSculpting® Elite System User Manual STANDARD SYMBOL SYMBOL STANDARD TITLE EXPLANATORY TEXT REFERENCE TITLE Graphical symbols for use ISO 7000-2492 on equipment. Medical devices — Symbols to be used with ISO 15223-1, medical device labels, Clause 5.1.4 Use by Indicates the date after which the labelling and information to date...
- Page 63 CoolSculpting® Elite System User Manual System Symbols STANDARD SYMBOL SYMBOL STANDARD TITLE EXPLANATORY TEXT REFERENCE TITLE Medical devices — Symbols to be used with ISO 15223-1, medical device labels, Storage Indicates the range of humidity to Clause 5.3.8 labelling and information to humidity which the medical device can be be supplied.
- Page 64 System Symbols CoolSculpting® Elite System User Manual STANDARD SYMBOL SYMBOL STANDARD TITLE EXPLANATORY TEXT REFERENCE TITLE Do Not throw this unit into a municipal Marking of Electrical and trash bin when this unit has reached the Electronic Equipment in Recycle: end of its lifetime.
- Page 65 CoolSculpting® Elite System User Manual System Symbols STANDARD SYMBOL SYMBOL STANDARD TITLE EXPLANATORY TEXT REFERENCE TITLE To identify the control that starts a IEC 60417 Graphical symbols for use function or operation. To identify the Reg. No. 5007 on equipment (Power) control that enables a function or operation to be engaged or activated.
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Page 66: System Specifications
System Specifications CoolSculpting® Elite System User Manual A P P E N D I X C System Specifications This product may contain remanufactured parts or parts that have had incidental use, all of which are equivalent in performance to new parts. Essential Performance Table 22: Performance Characteristics Device State... - Page 67 CoolSculpting® Elite System User Manual System Specifications Dimensions and Weight Table 24: Dimensions and Weight Item Height Depth Width Weight Control unit 53 in. 24 in. 24 in. 150 lbs 135 cm 61 cm 61 cm 68 kg Electrical Specifications Electrical Safety Class I Equipment, Single-Phase AC, Continuous Operation Contains Type BF Patient-applied Parts...
- Page 68 Use ports on the system exactly as instructed in this manual. Any other use of these ports may cause unexpected results. See “System Overview”. Do not use cables or accessories other than those provided by ZELTIQ. The use of other cables or accessories may result in increased electromagnetic emissions or decreased immunity to such emissions.
- Page 69 CoolSculpting® Elite System User Manual System Specifications Table 27: Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions CISPR 11 Group 1 The system uses RF energy only for its internal function; therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
- Page 70 System Specifications CoolSculpting® Elite System User Manual Electromagnetic Immunity Test IEC 60601 Test Level Compliance Level Environment - Guidance 0% U : 0.5 cycle at 0 0% U : 0.5 cycle at 0 Voltage dips, short Mains power quality should be , 90 , 135 , 180...
- Page 71 CoolSculpting® Elite System User Manual System Specifications Electromagnetic Immunity Test IEC 60601 Test Level Compliance Level Environment - Guidance NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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Page 72: Data Module Specifications (Modem And Wi-Fi)
Data Module Specifications (Modem and Wi-Fi) The device includes two data modules (Modem and Wi-Fi). Table 30 lists the specifications for each model. Use each module only with the antenna provided by ZELTIQ. Table 30: Data Module Specifications (Modem and Wi-Fi) - Page 73 System Specifications CoolSculpting® Elite System User Manual United States of America The CoolSculpting® Elite System with the data modem and Bluetooth has been tested and found to comply with the limits for a Class A digital device, pursuant to parts 15 and 18 of the FCC Rules (refer to Table 30 Data Modules Specifications).
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Page 74: Disposal Of Hazardous Materials
Disposal of Hazardous Materials CoolSculpting® Elite System User Manual A P P E N D I X D Disposal of Hazardous Materials Do not dispose system in domestic waste stream. Various components of the system may contain materials whose disposal is subject to regulation. The system contains a lithium battery, which is not serviceable by the customer.