neoBLUEcozy LED Phototherapy Service Manual Rev A

Caution: Federal Law (U.S.) restricts this device to sale or use by or on the order of a physician (or properly licensed practitioner). Natus is a registered trademark of Natus Medical Incorporated neoBLUE cozy is a trademark of Natus Medical Incorporated BiliBlanket is a registered trademark of Ohmeda. Bili-meter is a trademark of Olympic Medical. © 2006 Natus Medical Incorporated All rights reserved.

This manual may not be reprinted or copied in whole or in part without written consent from Natus Medical Incorporated. The content of this manual may change without notice. Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070 USA Telephone +1 650 802 0400 Fax +1 650 802 0401 Technical Service +1 888 496 2887 Technical Service Fax +1 650 802 8680 E-mail: [email protected] Customer Service +1 888 622 2427 Customer Service Fax +1 650 802 6620 E-mail: [email protected] International Support - Please contact your local Distributor. Distributor locations can be found at www.natus.com Fischer-Zoth Diagnosesysteme, GmbH Walter-Kolbenhoff Str. 34 D-82110 Germering Germany Phone: +49 (89) 89 45 97 3 Fax: +49 (89) 89 45 97 59

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C ONTENTS 1

Product Description ------------------------------------------------------------------------------- 1

2

Routine Maintenance Procedures ------------------------------------------------------------ 4 2.1

Cleaning -----------------------------------------------------------------------------2.1.1 Cleaning the Device --------------------------------------------------------2.1.2 Cleaning the Filter ---------------------------------------------------------2.1.3 Cleaning the Interior of the Light Enclosure ----------------------2.2 Performance Verification -----------------------------------------------------2.2.1 Verifying General Performance ----------------------------------------2.2.2 Adjusting Light Intensity -------------------------------------------------2.3 Safety Testing ----------------------------------------------------------------------

4 4 5 5 6 6 7 8

3

Troubleshooting the neoBLUE cozy light ------------------------------------------------ 10

4

Repair Procedures ------------------------------------------------------------------------------- 15 4.1 4.2 4.3 4.4 4.5 4.6

5

Removing the Plastic Cover ------------------------------------------------Removing the LED PCB -----------------------------------------------------Removing the ON/Standby Switch ---------------------------------------Removing the Temperature Warning LED -----------------------------About the Device Timer ------------------------------------------------------Spare Parts List -----------------------------------------------------------------

15 16 17 18 18 19

Specifications ------------------------------------------------------------------------------------- 20

Appendix A --------------------------------------------------------------------------------------------------- 21

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CHAPTER 1

PRODUCT DESCRIPTION The neoBLUE cozy LED Phototherapy System is a mobile phototherapy light that delivers narrow band high-intensity blue light via Light Emitting Diodes (LEDs) providing treatment for neonatal hyperbilirubinemia. 1.1 Intended Use The neoBLUE cozy LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The neoBLUE cozy light is designed for use within patient enclosures and positioned under the infant. 1.2 General Characteristics The light output is optimized to provide peak intensity of 30-35 µW/cm2/nm. Blue LED components emit light in the range of 400 – 550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective therapy for bilirubin reduction. The light is expected to operate as specified for at least 3,000 hours. LED components have minimal light output degradation over their lifetime when used as specified. Qualified Biomedical Equipment Technicians can adjust the light output. The light is housed in a plastic enclosure. The enclosure accommodates a reusable air mattress. The mattress provides a soft, translucent surface for the infant during treatment. Translucent disposable mattress covers provide a clean surface for the infant during treatment.

Mattress Cover:

neoPAD Mattress:

Light Enclosure:

Timer

Power Supply: Front vent & filter:

Main Device Components

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1.3 Power Information The light operates using a 12V DC medical grade power supply that plugs into the main power source (100 – 240V ~, 50 / 60 Hz). Only a Natus-approved power supply specifically for the neoBLUE cozy device can be used (Natus P/N 600157). A holder for the power supply is provided for attachment to the side of a bassinet or railing. A channel on the bottom of the light enclosure provides for safe routing of the power cord. 1.4 Additional References Note: neoBLUE cozy device User Manual is available separately. Contact Natus Technical Service at +1 (888)-496-2887 (toll-free, USA only) or +1 (650)-802-0400 or Email: [email protected]. (U.S., Asia, Australia, South America) Outside the US, please contact your local distributor for service.

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1.5

Safety Symbols Warning! Be aware of the following symbols, which appear on the light/accessories.

Symbol

Meaning Type BF rated for patient-applied parts Double-insulated (Class II) On (power on) Standby (power off) Attention, consult product documentation Consult Instructions for Use Always protect the baby's eyes with eye patches or equivalent Single-use only Do not use in presence of enriched oxygen or flammable gases Ambient Operating Temperature DC Voltage Authorized European Representative Manufacture Date

XXXX

Manufacturer Natus

WEEE Directive (Waste from Electrical and Electronic Equipment Directive) Symbol – Product should not be disposed of in normal waste Hot Surface

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CHAPTER 2

ROUTINE MAINTENANCE PROCEDURES This chapter describes routine maintenance procedures for the neoBLUE cozy device, referred to as the UUT (Unit Under Test) in this chapter: •

Cleaning (Section 2.1)

•

Performance Verification (Section 2.2)

•

Safety Testing (Section 2.3)

These procedures must be performed after any of the following events and/or as prescribed by the institution’s maintenance schedule. • • • •

Initial receipt of the UUT at the institution. Every 6 months for light intensity. UUT has been physically damaged or subjected to mechanical shock (i.e., being dropped). UUT has been submitted for maintenance or scheduled performance verification.

2.1

Cleaning

Cleaning of the UUT should be performed whenever any foreign material or liquid has been deposited on the UUT. Cleaning the UUT requires three tasks: • • •

Cleaning the Exterior of the Light Enclosure and Mattress (Section 2.1.1) Cleaning the Filter (Section 2.1.2) Cleaning the Interior of the Light Enclosure (Section 2.1.3) Warning! Disconnect UUT from AC power before cleaning.

2.1.1

Cleaning the Exterior of the UUT and Mattress

Remove the mattress from the UUT. Remove and discard the disposable mattress cover if necessary. Clean the exterior of the UUT and mattress with a mild solution of detergent and water, non-caustic commercial cleaner, or hospital disinfectant. Caution: Observe the following precautions: • • • • • •

While the UUT is splash resistant to IPX4 standards, avoid spraying liquids directly onto the light, or allow them to seep into the interior. Do not use caustic or abrasive cleaners. Do not clean with alcohol, acetone, or other solvents. Never immerse the UUT, mattress or its component parts. The mattress is not machine washable. The disposable mattress cover is single patient use only and should not be reused.

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2.1.2

Cleaning the Filter

The filter housing is located at the flat end of the UUT and held in place magnetically. Locate the hole on the standoff, indicated in Figure 1. Remove the filter housing from the UUT by inserting a pen or other pointed tool into the hole and pull away from the enclosure.

FIGURE 1 – REMOVING THE FILTER HOUSING

Remove the filter from the housing and rinse under warm water. Initially dry the filter with paper towels, and allow to air dry before placing back into the housing. An extra filter is provided so the UUT can be used while a filter is being cleaned. Place the filter back into the housing ensuring it completely covers all the vents. Place the filter housing back onto the UUT so that it is flush with the enclosure. Warning! 2.1.3

Do not operate the UUT without the filter and filter housing installed.

Cleaning the Interior of the Light Enclosure

Regular filter cleaning will reduce the amount of dust buildup on interior components. However, dust may accumulate over time. A Biomedical Equipment Technician should clean the inside of the UUT using a vacuum appropriate for electronics equipment. Cleaning frequency should be determined by visual inspection of the UUT interior and will vary depending on the environment (the recommended cleaning interval is at least once every 6 months). A soft brush may be used to wipe accumulated dust from the top of the individual LEDs to maximize intensity output.

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2.2

Performance Verification

This section discusses the tests necessary to verify UUT performance. •

Verifying General Performance (Section 2.2.1)

•

Adjusting the Light Intensity (Section 2.2.2)

All tests can be conducted without removing the UUT light enclosure. If the UUT fails to conform or cannot be adjusted to conform, repairs must be made to correct the problem before the instrument is returned to the user.

Tools and Test Equipment

Type

Photometer* Potentiometer Adjustment Tool

Ohmeda BiliBlanket® Meter II or equivalent* GC Electronics 8608 or equivalent Guard Dog Bones glasses (p/n 413BB) are recommended and are available online at www.safetyglasses.com or via phone at 1-800-870-6189.

Safety Glasses

Use a model appropriate for measuring surface temperature Any non-abrasive non-static surface

Thermometer Work Pad

Note: *If a different photometer is used please refer to the Conversion Chart in Appendix A. If the meter is not listed, please contact Natus Technical Service before adjusting light intensity. Use of a photometer with a HOLD feature is necessary if the photometer display cannot be read while the photometer sensor is faced down. Intensity measurements are based on the patient surface using Natus air mattress and disposable mattress cover. Use of other components may produce unexpected levels of light intensity.

2.2.1

Verifying General Performance

1.

Confirm air vents are not blocked.

2.

Connect the power supply DC power cord to the UUT DC input and the power supply AC cord to a medical grade AC receptacle or an appropriately grounded receptacle. Warning!

Operator Safety - Bright light source: Do not look directly at LED components from above. Sensitive individuals may experience headache, nausea, or mild vertigo when exposed to the illuminated area. Observe from an angle of 15° or greater. To alleviate potential effects, use the UUT in a well-lit area or wear yellow or tinted safety glasses.

3.

Switch the UUT on. Verify the ventilation fan is running and the LED panel lights.

4.

Remove the mattress and mattress cover from the enclosure.

5.

Examine light panel geometry for unlit LED components.

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Note: The UUT can conform to specifications with some components unlit. However, if a large number are unlit, the UUT may not meet minimum values. Light intensity may need to be increased if many components are unlit. Note: Increasing intensity will reduce LED life. 6.

Place the mattress and mattress cover back on the device.

7.

Place the photometer sensor lens facing down, in the approximate center, on top of the mattress/cover. Note:

It is important that the photometer sensor be parallel to the mattress plane.

8.

After a stable reading is attained, move the photometer to establish peak light intensity reading. Peak intensity location should be in the approximate center of the mattress.

9.

If the photometer reading is between 30-35 µW/cm2/nm, skip to step 11.

10.

If the reading is not within range, leave the photometer in position and skip to Section 2.2.2 Adjusting Light Intensity.

11.

If all previous steps generate satisfactory results, the UUT performance has been verified and the UUT can be returned to the user. Switch the UUT to stand-by and return it to service.

2.2.2

Adjusting Light Intensity Light intensity is controlled by a potentiometer located behind the air filter. Refer to Step 2.1.2 for instructions about removing the filter housing.

FIGURE 2 – ADJUSTING THE LIGHT INTENSITY

Warning!

Moving fan parts: The device fan is located behind the filter housing. Beware of moving parts.

Using the potentiometer adjustment tool, adjust the potentiometer to a light intensity of at least 35 µW/cm2/nm by following the instructions below. Prior to adjustment, turn on the UUT a minimum of 5 minutes to allow the LEDs to stabilize. 1.

Place Phototherapy light meter on top of the mattress/cover.

2.

Measure and record the light intensity at 5 Points as shown in Figure 3. Please note that the LEDs only cover the entire patient surface area, not the entire surface area of the device. Take measurements anywhere there are LEDs.

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FIGURE 3 - MEASUREMENT LOCATIONS

EXAMPLE: Point 1: 29µW/cm2/nm Point 2: 33µW/cm2/nm Point 3: 32µW/cm2/nm Point 4: 27µW/cm2/nm Point 5: 25µW/cm2/nm 3.

Place the light meter over the location of the median value and adjust the intensity of this location to 35 µW/cm2/nm. EXAMPLE: Point 1(29µW/cm2/nm) is the median value since there are two points with higher readings and two points with lower readings. Increase Point 1’s measurement until photometer reads 35µW/cm2/nm (29+6).

4.

Adjust clockwise to increase, counterclockwise to decrease intensity. Note: Adjusting the potentiometer so that intensity is greater than 35 µW/cm2/nm will decrease life of the LED components.

5.

If steps 1-4 comply, replace the filter housing and return the UUT to service.

6.

If steps 1-4 do not comply, refer to Chapter 3, Troubleshooting the neoBLUE cozy light.

2.3

Safety Testing

The safety tests listed below meet the standards of, and should be performed in accordance with, IEC 60601-1, Amendment 1, Amendment 2, and UL 60601-1, for instruments as Class 2 and TYPE BF and ANSI/NFPA Standard 99. Note: The power supply has a functional earth contact for electromagnetic compliance tests. The earth contact does not go to the main device housing. The power supply is double insulated. Applicable tests for these standards are listed below (Tables 2.1, 2.2 & 2.3). Technicians must be familiar with local and national standards applicable to the institution. Test equipment and its application must comply with the applicable standard. •

TABLE 2.1

Power Cord Ground Integrity

•

TABLE 2.2

Earth Leakage Current

•

TABLE 2.3

Main Enclosure Leakage

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Maximum Current Limits are listed below for each test and standard. TABLE 2.1

Power Cord Ground Integrity 100 milliohms or less

TABLE 2.2

Earth Leakage Current

AC Line Cord Polarity Normal Reversed Normal Normal

Line Cord

Neutral Cord

IEC 60601-1

Closed Closed Open Closed

Closed Closed Closed Open

500 µA 500 μA 1000 µA 1000 µA

UL 2601-1 ANSI/NFPA 99 250 µA 250 µA 500 µA 500 µA

TABLE 2.3 Main Enclosure leakage Current AC Line AC Line Cord Cord IEC 60601-1 Ground Neutral Conductor Conductor Normal Closed Closed 100 uA Normal Closed Open 500 uA Normal Open Closed 100 uA Reversed Closed Closed 500 uA Reversed Open Closed 500 uA Reversed Closed Open 500 uA * AAMI/ANSI-ES1 does not include opening the neutral line conductor AC Line Cord Polarity

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UL 2601-1 AMI/ANSIE1 300 uA 300 uA 300 uA* 300 uA 300 uA* 300 uA

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CHAPTER 3 TROUBLESHOOTING THE NEOBLUE COZY LIGHT Warning! Disconnect power cord before opening the light for repair. Warning! Beware of moving fan blades if cover is removed. The following symptoms are discussed in this section: •

Light does not appear when device is turned on

•

Cover has become excessively hot (Above 40°C/104°F)

•

Indicator warning LED turns on, blue light goes off

•

LED string(s) goes out

•

Multiple LED strings go out

•

Cannot attain appropriate intensity / Light does not maintain intensity

•

Excess noise

When opening the neoBLUE cozy to examine the LED Panel, follow the procedures described in chapter 2, Routine Maintenance Procedures and chapter 4, Repair Procedures. The following illustration is provided to help the Biomedical Equipment Technician locate major measurement points.

FIGURE 4 – MAJOR ELECTRICAL TEST POINTS

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TABLE 3.1

Troubleshooting Guide

Warning! Disconnect power cord before opening the light for repair.

SYMPTOM

PROBABLE CAUSE

CORRECTIVE ACTION

No power

Verify that the AC outlet is functioning.

Power switch not in correct position

Ensure that the power switch is in ON (|) position. Check to make sure that the power cord is plugged in all the way to the device socket and on the other end at the AC mains outlet. If the device will still not turn on try another power cord.

Power cord not plugged in all the way; or is defective

If none of the above restores the light, open the main enclosure and check for the following:

Damaged power cable LIGHT DOES NOT APPEAR WHEN DEVICE IS TURNED ON

Plug power cord in, exercising caution due to live circuit (12V DC, up to 5.4A). Check voltage at JP1 for the following values when the switch is in the ON ( | ) position (measure with respect to common on the power jack): Pin 1 +12V ± 5% (11.4 V To 12.6 V) Pin 2 +12V ± 5% If both voltages are incorrect, replace the PCB. If the voltage is correct at Pin 1 but incorrect at Pin 2, verify that the power switch cable is plugged in securely and is not damaged. Replace the cable or switch if necessary. Contact Natus Technical Service or authorized service provider.

Damaged LED PCB

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Plug power cord in, exercising caution due to live circuit (12V DC, up to 5.4A). Check the voltage at the power jack for 12 ± 5% (11.4 V To 12.6 V). If an incorrect voltage is present, remove cable from the jack and check open circuit voltage at the end of the power supply cable connector. If the voltage is still incorrect, replace the power supply. Contact Natus Technical Service or authorized service provider.

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SYMPTOM

PROBABLE CAUSE

Verify that vents are not blocked.

Air vents are blocked

MATTRESS SURFACE HAS BECOME EXCESSIVELY HOT (ABOVE 40°C/104°F)

CORRECTIVE ACTION

If the patient surface is above 40°C (104°F), verify that the fan is functioning correctly.

Device not used within specified operating temperature

Operating conditions for the neoBLUE cozy light are 20 – 30°C (68 - 86°F). Verify that temperature is within range, and adjust ambient temperature or move the device to a cooler area.

Excessive heat is being trapped underneath the device

Remove any mattress or cushioning from underneath the device so that the device is operating on a hard, flat surface.

If none of the above corrects the problem, open the main enclosure and check for the following: Fan is not running

The fan is not a user serviceable component. Replace LED PCB. Contact Natus Technical Service or authorized service provider. Verify that vents are not blocked.

Air vents are blocked

INDICATOR LED TRIGGERS (TEMPERATURE CUTOFF POINT REACHED)

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If the infant becomes too warm, verify that the fan is functioning correctly. To reset Indicator LED, turn device off and on again.

Device not used within specified operating temperature

Make sure that the device is not used in ambient temperature greater than 30°C, causing device to turn off to prevent overheating. To reset Indicator LED, turn device off and on again.

Device placed on a soft surface (i.e. mattress, bed)

The device should be placed on a hard surface during operation. The mattress or any soft surface in contact with the center bottom of the device will trap heat, causing the device to overheat, triggering the indicator LED.

Filter has become clogged

Clean filter per Section 2.1.2.

Main enclosure fan is not running

Verify that fan is able to spin freely. If necessary, replace LED PCB (fan is not available separately). Contact Natus Technical Service or authorized service provider.

Component on PCB board has become faulty.

Replace LED PCB (see Chapter 4). Contact Natus Technical Service or authorized service provider.

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SYMPTOM

LIGHT INTENSITY READS BELOW 30 µW/cm2/nm

LIGHT INTENSITY WILL NOT ADJUST TO 35 µW/cm2/nm

PROBABLE CAUSE

CORRECTIVE ACTION

Device needs to be cleaned

Clean the surface of the device per Section 2.1. Replace the disposable cover if soiled and clean or replace the mattress if necessary.

Light intensity needs to be adjusted

Adjust light intensity per Section 2.2.2.

Natus approved mattress / disposable cover not used

The neoBLUE cozy mattress and disposable are specially designed to transmit the greatest intensity possible. Use with alternate materials will decrease the efficacy of the device.

Device requires cleaning

Clean device per Section 2.1.

Damaged PCB

Near the end of life of the LED PCB

Maximum adjustment limit reached

DEVICE DOES NOT OPERATE AT HIGHER TEMPERATURES EVEN THOUGH WITHIN 30°C. INDICATOR LED TRIGGERS.

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Replace LED PCB (see Chapter 4). Contact Natus Technical Service or authorized service provider. LEDs slowly dim as they age and may have exceeded their useful life (> 3,000 operational hours). If the maximum adjustment has been reached, replace LED PCB as part of routine maintenance. Contact Natus Customer Service or authorized service provider to purchase a replacement. Replace LED PCB (see Chapter 4). Contact Natus Technical Service or authorized service provider.

Near the end of life of the LED PCB

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The device has exceeded its useful life (> 3,000 operational hours). As the device ages, the operating temperature decreases due to the increased amount of heat generated by the LED PCB. This poses no danger to the patient as the device will automatically turn off when it reaches an overheat condition, but the device can no longer operate at the higher temperature range. Place the device in a cooler location or, if necessary, replace LED PCB as part of routine maintenance. Contact Natus Customer Service or authorized service provider to purchase a replacement.

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SYMPTOM

PROBABLE CAUSE

CORRECTIVE ACTION

Increase the intensity if necessary. If the device still produces enough light there is no need to replace the panel. ONE OR MORE LED STRINGS GO OUT; CANNOT ATTAIN APPROPRIATE INTENSITY

LED short or open

Damaged LED light panel or Maximum adjustment limit reached

If appropriate intensity cannot be reached, replace LED PCB (see Chapter 4). Contact Natus Technical Service or authorized service provider.

Internal wires are in contact with the fan

Open device and verify that the wires do not come into contact with the internal fan. Route wires away from fan.

Improper fit of the cover

Verify that the device is assembled correctly. Open the device while running and see if the device runs quieter. Reassemble the device. If still noisy, contact Natus Technical Service or authorized service provider.

LED board damaged

Contact Natus Technical Service or authorized service provider.

EXCESSIVE NOISE

BLUE LEDS BLINK / FLICKER

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If the device does not produce enough light, replace the LED light panel. Contact Natus Technical Service or authorized service provider.

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CHAPTER 4

REPAIR PROCEDURES This section presents procedures for repairing the neoBLUE cozy light, referred to as the UUR (Unit Under Repair) in this chapter. Only qualified technical personnel should open the light enclosure, remove and/or replace components or make adjustments. If the medical facility does not have qualified personnel, please contact Natus Technical Service or your authorized service representative for further assistance. Tools Screwdriver -- Phillips, Medium Wire cutter The Biomedical Equipment Technician must complete Performance Verification and Safety Testing procedures listed in Chapter 2 after any repair is completed and the UUR is reassembled. The UUR can be disassembled down to all major component parts, including: •

Removing the Plastic Cover (Section 4.1)

•

Removing the LED PCB (Section 4.2)

•

Removing the ON/Standby Switch (Section 4.3)

•

Removing the Temperature Warning LED (Section 4.4)

Warning! Disconnect the AC power cord before beginning disassembly as high currents can be encountered during disassembly. CAUTION:

Approved anti-static measures must be used anytime the UUR is disassembled.

4.1

Removing the Plastic Cover

1.

Place the UUR on a suitable work surface (non-abrasive, non-static).

2.

Remove the four Phillips head screws along the outer perimeter of the plastic cover. Locations are indicated in Figure 5.

Figure 5 – Screw removal

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3.

The plastic cover is removed by gently pulling it up from the base. Use caution; the cover may fit tightly onto the enclosure.

4.

If you are replacing the plastic cover, obtain the replacement and reverse the previous steps. During replacement, take care to place the cover over the foam cushioning strips. Verify that the foam strips are properly adhered to the base. Press down any strips that may have lifted. Use care when routing switch and LED cables so that they do not interfere with fan operation or become pinched in between cover and base. Recommended torque is 15 in. lbs.

5.

If no further repair is required, return to Chapter 2, and complete Performance Verification and Safety Tests. If further disassembly is required; store the plastic cover in a protected area and proceed to Section 4.2, removing the LED PCB.

4.2

Removing the LED PCB

The procedure in Section 4.1 must be completed before beginning these steps. 1.

Unplug the power connector [JP2], power switch connector [JP1], temperature warning LED connector [JP3], and Fan PCB [JP4] from the board. Note connector orientation for replacement.

2.

Clip and remove the cable tie securing the power connector ferrite from the board.

3.

Remove the four Phillips head screws securing the LED PCB to the light enclosure. Locations are circled in Figure 6.

Figure 6 – Removing the LED PCB

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CAUTION: Do not grasp the LED components to remove the LED PCB from the light enclosure. Pull up from the edges of the PCB, starting from the end under the fan. 4.

If you are replacing the LED PCB, obtain the replacement and place into enclosure.

5.

Reconnect connectors to JP1, JP2, JP3, and JP4 and secure the ferrite with a new cable tie. Note: When reconnecting the LED PCB, verify the JP1, JP2, JP3, and JP4 connectors are mated correctly.

6.

If no further repair is required, reverse all previous steps in Chapter 4, return to Chapter 2, and complete Performance Verification and Safety Tests.

4.3

Removing the ON/Standby Switch

The procedure in Section 4.1 must be completed before beginning these steps. 1.

The switch is held in the light enclosure by spring tabs, two on each side of the switch. See Figure 7.

Figure 7 – Switch Removal 2.

Press the tabs against the switch body while pushing the switch out the top of the light enclosure. Note: During reinstallation, orient the switch so that the outermost terminal is closest to the center of the device as shown in Figure 7. When installed correctly, the device will turn on when the switch is pressed to the right.

3.

Disconnect the quick-connect spade terminals from the power switch. If you are replacing the ON/Standby switch, obtain the replacement and reverse the previous steps.

4.

If no further repair is required, reverse all previous steps in Chapter 4, return to Chapter 2, and complete Performance Verification and Safety Tests.

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