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Procedure No. 464-20081015-01 ( Major ) Frequency-Doubled Nd-YAG Surgical Lasers

Frequency-Doubled Nd-YAG Surgical Lasers

Procedure No. 464-20081015-01 ( Major )

BiomedicalBenchmark™ © 2011 ECRI Institute. All Rights Reserved. 2

Used For:
Lasers, Nd:YAG, Frequency-Doubled, Surgical [17-729]

Commonly Used In:

Operating rooms, short procedure areas, endoscopy laboratories

Scope:
Applies to general-purpose frequency-doubled Nd:YAG surgical lasers that include contact and/or
noncontact flexible fiberoptic delivery systems (either reusable or disposable), emit visible green light
energy at 532 nm, and can provide sufficient power output to coagulate and vaporize tissue; applies to
low- and high-power frequency-doubled Nd:YAG surgical lasers that are typically used for general
surgery, gastroenterology, bronchopulmonary, neurosurgery, gynecology, and ENT surgery procedures;
does not apply to frequency-doubled Nd:YAG lasers used solely for ophthalmic surgery; also does not
apply to other ophthalmic lasers or to CO2 lasers, Nd:YAG lasers, argon lasers, or other surgical lasers;
however, many of the tests listed herein can be used or modified for these other lasers

Risk Level: High

Type Interval Time Required

Major 12 Months 0 hours

Minor 6 Months 0 hours

Overview:
Frequency-doubled Nd:YAG surgical lasers are normally checked before each use by the laser's power-
on self-test and by user examination of the aiming beam and the delivery system to be used. This
minimizes the need for frequent additional periodic testing.
Manufacturers or outside service vendors often maintain lasers for hospitals. The extent and frequency of
inspection by hospital personnel should be coordinated with these outside services.
Failure of a frequency-doubled Nd:YAG surgical laser can cause patient or staff injury, abrupt
interruption of a surgical procedure, or damage to the laser system. These lasers must be meticulously
maintained to ensure proper and safe operation.
Frequency-doubled Nd:YAG surgical lasers affect tissue by delivering green visible light energy at a
sufficient power density to cause vaporization and/or coagulation. The 532 nm light energy is
preferentially absorbed by hemoglobin and is typically absorbed within 3 mm of the tissue surface.
Frequency-doubled Nd:YAG surgical laser fibers are most often used in contact with or close to tissue to
cause coagulation or vaporization. Moving the fiber tip away from the tissue lowers the power density,
causing less tissue to be vaporized or coagulated.
General-purpose frequency-doubled Nd:YAG surgical lasers direct the beam of an Nd:YAG laser
through a crystal that halves the 1,064 nm wavelength (i.e., doubles the frequency) to 532 nm. (The
Nd:YAG laser uses an yttrium-aluminum-garnet [YAG] crystalline rod that is doped with neodymium
[Nd].) Energy exiting the crystal is typically directed into a flexible optical fiber that transmits the laser
energy to the tissue. The fiber may be used with additional devices (e.g., through an endoscope) and/or
with a laser handpiece or a laser micromanipulator (used to interface the laser with the surgical
microscope). These attachments can focus the energy into a small spot size at a known working distance
and/or a specific beam direction to accomplish special tasks. In addition, frequency-doubled Nd:YAG
lasers can emit a train of pulses or a single pulse.
Like most lasers, frequency-doubled Nd:YAG lasers are inefficient in converting electrical energy into
laser energy. As a result, excess heat is generated in the laser cavity and doubling crystal, requiring a
cooling system. Most frequency-doubled Nd:YAG lasers use water/air cooling systems that are self-
contained, connected to a freestanding chiller system, or connected to a water supply and drain.
With frequency-doubled Nd:YAG surgical lasers, unlike those lasers that use mirror delivery systems
(e.g., articulating arms on CO2 lasers), it is not necessary to periodically verify coincidence of the
aiming and therapeutic beam or to assess the therapeutic beam pattern within the beam or spot. Since the
therapeutic and aiming laser beams are transmitted through a single optical fiber, these two beams are
coincident as they exit the fiber. Any beam pattern distortion at the fiber entrance would be eliminated as
the laser beams travel through the fiber because of internal reflections within the fiber. Misalignment of
the beam at the fiber entrance would result in decreased power output or loss or distortion of the aiming
beam. In a well-aligned system, any significant problem with the therapeutic beam pattern introduced by
an accessory would be apparent by examining the visible aiming beam.

Test Apparatus, Supplies, Parts:

 Electrical safety analyzer

 Laser radiometer (0.01 to 20 W, 0.1 to 100 W, and 0.01 to 10 sec)

 Calibrated flowmeter (optional)

 Outlet test fixture (optional)

Special Precautions:
Inspecting and maintaining lasers is a dangerous but necessary process, and far greater care is required
than with most devices. Personnel who inspect or service lasers should receive special training from the
manufacturer or from a qualified alternative training source.
Laser energy can cause serious injury, particularly when the internal interlock is overridden or in any
other situation in which the energy does not diverge significantly over long distances. Under some
circumstances, the beam may not diverge significantly, even a full room length or more away from the
laser (and can harm tissue or burn material even at this distance). Therefore, exercise great care
whenever a laser beam is accessible. Area security and use of personnel protective devices and practices
should be consistent with hospitalwide laser safety procedures and/or should be approved by the laser
safety committee.
In addition, windows should be covered laser opaque with nonreflective material to prevent transmission
of laser energy to other areas.
Wear appropriate laser safety eyewear at all times whenever the laser is in the operating mode.
WARNING: Do not stare directly into the aiming system beam or the therapeutic laser, even when
wearing laser safety eyewear.Avoid placing the laser beam path at eye level (i.e., when kneeling, sitting,
or standing).
Do not perform these procedures when a patient is present or clinical staff are working, and do not aim
the laser across a path that a person might normally use as a thoroughfare. Furthermore, at minimum,
post doors to the room with appropriate laser safety signs stating that the laser is in use and that it is
unsafe to enter the room without authorization by the service person performing the procedure. A second
person should be present, especially during procedures of recognized risk, to summon help in case of an
accident.
The laser should remain in the off position when not in use. When in use, it should be in the
standby/disabled mode. Do not switch it to the operating mode until the procedure is about to begin and
the laser and its delivery system are properly positioned. If the procedure must be interrupted, disconnect
the laser from line voltage, and remove the laser operation key and store it in a controlled location.
Do not use the laser in the presence of flammable anesthetics or other volatile substances or materials
(e.g., alcohol), or in oxygen-enriched atmospheres, because of the serious risk of explosion and fire.
Remove from the working area or cover with flame-resistant opaque material all reflective surfaces
likely to be contacted by the laser beam. Whenever possible, use a firebrick or other nonflammable
material behind the target material (e.g., black Delrin) when the laser is to be activated. A CO2 fire
extinguisher should be readily available.
Some surgical lasers use high voltages (e.g., 20 kV), which can be lethal. Capacitors may store charges
long after the device has been disconnected from line voltage. Consult the manufacturer's recommended
procedures for servicing high-voltage laser circuits, and avoid contact with any portion of the high-
voltage circuit until you are certain that the charge has been drained. In such instances, a good ground
must be present; preferably, use a redundant ground strap if you must enter the laser cabinet. When
possible, disconnect the laser from line voltage before entering the laser cabinet, and use insulated gloves
for those procedures in which contact with a high-voltage source is possible (and the gloves are not
otherwise contraindicated). Ensure that equipment intended to be used to measure, drain, or insulate high
voltages carries the appropriate insulation rating (e.g., above 20 kV).
Where possible, perform tests with the laser turned off. Because of the presence of high voltage, perform
the Grounding Resistance test before any other test that requires operation of the laser.
WARNING: Lasers may be damaged by switching between normal and reverse polarity while the device
is on. If reverse-polarity leakage current measurements are made, turn off the unit being tested before
switching polarity. Also, lasers powered by three-phase electrical systems may be damaged if proper
electrical phase connections are not made initially and maintained thereafter. Thus, do not switch
conductor connections or wiring configurations for any tests, including leakage current measurement. Do
not conduct electrical leakage current tests with reversed-polarity wiring. Thus, do not conduct reversed-
polarity leakage current testing on three-phase powered lasers.
WARNING: Do not use an anesthesia or other similar bag that may have a mold-release agent (e.g.,
starch, talc) on its inside surface because the agent could contaminate the gas recirculation system of the
laser and ultimately contaminate a patient wound during a subsequent procedure.
Report any laser accident immediately to the laser safety officer or equivalent, as well as to the hospital
risk manager.

Procedure:
Be sure that you understand how to operate the equipment, the significance of each control and indicator,
and the alarm capabilities. Before beginning an inspection, carefully read this procedure, the operators
manual, and the inspection and preventive maintenance procedures recommended by the manufacturer
(typically included in the service manual). Use the BiomedicalBenchmark Support Assessment Form to
document a maintenance decision that reflects past experience with this type of equipment and the
environment where it is used. Then use the IPM Procedure Customization Tool to modify this procedure
as needed; the program will generate a documentation form with the corresponding changes.

Qualitative tasks: Chassis/Housing.

Verify that the key has not been left in the laser. (Remove it if it has been, and inform users of the
importance of storing the key in a controlled location.) Examine the exterior of the laser for cleanliness
and general physical condition. Be sure that all housings are intact and properly aligned, that assembly
hardware is present and tight, that any retractable parts slide easily and lock in place if so constructed,
that there are no signs of spilled liquids or other evidence of abuse, and that there are no obvious signs of
water or oil leakage.

Shutters.

If manual shutters for the aiming system or the therapeutic laser are accessible, ensure that they operate
smoothly and correctly. Be sure to leave the shutter in the proper position for normal operation.

Casters/Brakes.
Verify that the correct casters have been supplied with the laser (e.g., size, correct swivel). Verify caster
and brake operation. Check that the casters roll and swivel freely. Check the operation of swivel locks.

Mounts/Holders.

Check that the mounts securely contain any gas cylinders that may be in use. Be sure that mounts or
holders intended to secure the fiber to the fiber support (to protect the fiber when in use) are present, in
good working order, and being used. Similarly, check mounts or holders for other devices (e.g., external
radiometers, footswitches). If the laser is mounted on a stand or a cart, examine the condition of the
mount. Verify that the mounting apparatus is secure and that all hardware is firmly in place.

AC Plug.

Examine the AC power plug for damage. Wiggle the blades to determine whether they are secure. Shake
the plug, and listen for rattles that could indicate loose screws. If damage is suspected, open the plug and
inspect it.

Line Cords.

Inspect line cords for signs of damage. If a cord is damaged, replace the entire cord, or, if the damage is
near one end, cut out the defective portion.

Strain Reliefs.

Examine the strain reliefs at both ends of the line cord. Be sure that they grip the cord securely.

Circuit Breakers/Fuses.

If the laser has a switch-type circuit breaker, check that it moves freely. If the laser is protected by an
external fuse(s), check its value and type against what is marked on the chassis or noted in the instruction
or service manual. Ensure that a spare is provided or readily available.

Tubes/Hoses.

Check the condition of all cooling-system hoses and any other hoses or tubing the laser may have (e.g.,
drain, gas). Check that they are of the correct type; that they have not become cracked and do not show
other signs of significant abuse; that they are connected correctly and positioned so that they will not
leak, kink, trail on the floor, or be caught in moving parts; and that they are secured adequately to any
connectors.

Cables.

Inspect all cables and their channels or strain reliefs for general physical condition. Examine cables
carefully to detect breaks in insulation and to ensure that they are gripped securely in the connectors at
each end to prevent strain on the cable.
Fittings/Connectors.

Examine all optical (e.g., fiber), liquid, and electrical fittings and connectors for general physical
condition. Liquid fittings should be tight and should not leak. Electrical contacts should be straight,
clean, and bright.

Filters.

Check the condition of all liquid and air filters. Some frequency-doubled Nd:YAG surgical lasers require
deionized water, and most require special filtration. Measuring the pressure drop across a liquid filter can
be helpful in determining whether the filter should be replaced. Clean or replace filters according to the
manufacturer's recommendations (e.g., replace if the pressure drop is >5 psi), and indicate this in the
preventive maintenance section of the inspection form. Clean or replace air filters and radiators that are
obviously dirty.

Controls/Switches.

Examine all controls and switches for physical condition, secure mounting, and correct motion. If a
control has fixed-limit stops, check for proper alignment, as well as positive stopping. Check membrane
switches for tape residue and for membrane damage (e.g., from fingernails, pens, surgical instruments).
If you find such evidence, notify users to avoid using tape and sharp instruments. During the inspection,
be sure that each control and switch works properly.

Remote.

Examine the exterior of the control for cleanliness and general physical condition. Be sure that housings
are intact, that assembly hardware is present and tight, and that there are no signs of spilled liquids or
other serious abuse. If the remote control is attached by cable to the laser, ensure that the cable and any
connectors are in good condition. Examine all controls and switches for general physical condition,
secure mounting, correct motion, and intended range of settings. Where a control should operate against
fixed-limit stops, check for proper alignment as well as positive stopping. During the inspection, be sure
to check that each control and switch performs properly.

Footswitch.

Examine the footswitch for general physical condition, including evidence of spilled liquids.
Footswitches for lasers include an internal switch that activates according to the depth of pedal
depression. It is usually possible to feel the vibration caused by closure of the switch, even through a
shoe. Check that the internal switch is operating and that the footswitch does not stick in the on position.
Some footswitches include two internal switches; in this case, verify the operation of both. Some
footswitches also include a switch to operate the liquid- or gas-cooling system. Check to be sure that this
switch operates reliably.
During the procedure, check to be sure that the laser activates consistently when the footswitch is
depressed and that the fiber-coolant system operates properly when the fiber-coolant switch is activated
and deactivated. Flex the cable at the entry to the switch, and, using an ohmmeter, check for internal wire
breaks that cause intermittent operation. Confirm that strain reliefs are secure.
Examine the male and female connectors for attaching the footswitch to the laser cabinet to be sure that
no pins are bent and that no other damage is present. Ensure that the connector secures acceptably to the
laser cabinet.
Pumps/Fans/Compressors.

Check the physical condition and proper operation of these components, if present. If lubrication is
required, note this in the preventive maintenance section of the form. Clean any obvious dust from these
components.

Fluid Levels.

Check all fluid (e.g., coolant) levels. Refill or change the fluid according to the manufacturer's
recommendations, and note this on the preventive maintenance section of the inspection form. If an
external water supply is in use, ensure that the water pressure is properly regulated and at the appropriate
pressure and that the supply and drain system is properly configured (e.g., filters are oriented for proper
flow, drain hoses are positioned in a sink or drain).

Battery.

Inspect the physical condition of batteries and battery connectors, if readily accessible. If a remote
control or display is battery powered, check or replace the battery (periodic prophylactic battery
replacement is often preferred to risking battery failure during use). When it is necessary to replace a
battery, label it with the date.

Indicators/Displays.

During the inspection, verify proper operation of all lights, indicators, meters, gauges, and visual
displays on the laser and remote control. Ensure that all segments of a digital display function. Note any
error messages displayed during the power-on self-test.
If primary and remote-control indicators and displays can be used at the same time or if control can be
switched from one to the other during a procedure, operate the laser in a way that will verify that the
same information (e.g., settings, displays) is indicated on both control panels.
If display screens or digital displays are provided for user prompts or for viewing accumulated
information (e.g., pulse or accumulated energy counter), ensure that each display provides the
information expected. Ensure that user prompts occur in the proper sequence. Store some sample
information, and verify that it is correct. If a feature to manually reset this information is available,
ensure that it works.

Time/Date Settings.

Verify that the time and date settings on the unit are correct.

Alarms/Interlocks.

Operate the laser in a manner that will activate the self-check feature, if present, and verify that all visual
and audible alarms activate according to the manufacturer's documentation. If no self-check feature is
present, operate the laser in a manner that will activate each audible and visual alarm; be sure to test only
those alarms that will not cause damage to the laser or present an unnecessary risk of laser beam
exposure.
If a door or window interlock is used, ensure that it deactivates the laser properly. (Do not disassemble
major parts of the laser to test internal interlocks.) After deactivating the laser and reclosing the door or
window, check to be sure that the laser will restart. Be sure to check the interlocks in all locations where
the laser is used. (For some lasers, the function of the interlocks can be checked using an ohmmeter.)
If the laser is equipped with an emergency "kill" switch, test this feature to be sure that it deactivates the
laser and that the laser will subsequently restart.

Audible Signals.

Operate the laser to activate any audible signals (e.g., laser emission, setting change). Check for proper
operation, and verify that the signal can be heard in the environment in which the laser will be used.

Labeling.

Check that all placards, labels, and instruction cards noted during acceptance testing are present and
legible. Check to see that the instruction manual is kept with the laser or is readily available.

Accessories.

Verify that all necessary accessories are available and in good physical condition. Set up reusable
accessories with the laser to ensure compatibility and proper functioning.
Checking all fibers or accessories during a single inspection and preventive maintenance procedure is
unnecessary as long as accessories are routinely checked by the person(s) responsible for laser setup and
operation. In addition, many of the accessories are sterile and would require resterilization before use,
making the laser potentially unavailable. Be sure to check with the person responsible for scheduling the
use of the laser before beginning the procedure.

Fibers.

For the test fiber and before each use, examine the aperture connector, cable, and tip of each fiber to be
used, as well as the fiber support, for cleanliness and general physical condition. Ensure that the aperture
connector properly seats into the laser aperture in the laser cabinet. Examine the distal end of fibers to
ensure that any connecting mechanisms (e.g., threads) are in proper working order.
If a fiber appears to be dirty or damaged, remove it from service. If a fiber is reusable, notify the
person(s) responsible for fiber repair. The fiber should be repaired and/or cleaned according to the
manufacturer's recommendations. Verify fiber performance.

Handpieces.

Examine each handpiece component (e.g., body, tips, lenses) for cleanliness and general physical
condition. Examine individually only those components that are intended for removal during normal use
and storage. (Do not remove other parts that are press-fit or attached by screws, bolts, or snap-rings.) If
lenses are detachable, be sure not to touch the lens surface; handle lenses by the edges only. Consult the
manufacturer's recommendations for the procedures and cleaning agents to use to clean lenses.
Ensure that major subcomponents of the handpiece, when assembled, are secure. Ensure that the
mechanisms used to connect the handpiece(s) to the fiber are in good working order and that they
reliably secure each handpiece to the fiber.

Microscope Micromanipulator.
Examine the microscope micromanipulator for cleanliness and general physical condition. Be sure to
handle it by the main body; do not hold it by the joystick, and do not touch the reflecting lenses in the
body. Inspect micromanipulators provided by both the laser manufacturer and the laser accessory
manufacturer.
Ensure that the reflecting surfaces and lenses are intact and clean. Consult the manufacturer's
recommendations for the procedures and cleaning agents to use to clean reflecting surfaces and lenses.
Examine the joystick to ensure that it is firmly attached and that it freely moves the reflecting lens. If a
finger rest is present, ensure that it is firmly attached and properly oriented.
If a zoom focus feature is present, be sure that it turns easily and does not slip. Examine each objective
lens to ensure that it is intact and clean. Do not touch the lens surface. Consult the manufacturer's
recommendations for the procedures and cleaning agents to use to clean the objective lenses. Carefully
insert each lens into the micromanipulator, and ensure that it fits snugly.
There should be no visible dirt or residue in the optical path of the laser aperture. Ensure that any
mechanism to close off the fiber laser aperture (fiber port) is clean, operates smoothly, and is in use.
Inspect the mechanism used to attach the micromanipulator to the microscope and to the laserto ensure
that all parts are present and that it is in good working order. Connect the micromanipulator to the
microscope and to the laser to check for a secure connection.

Safety Filters.

Verify operation of safety filters in the microscope and endoscope delivery systems.

Aiming Beam.

Frequency-doubled Nd:YAG surgical lasers typically use an attenuated therapeutic beam as the aiming
beam. Activate the aiming beam (without the therapeutic beam), and verify that it produces a round,
uniformly bright spot, with no halo.

Laser Aperture.

WARNING: Make this inspection with the laser powered off.Remove and inspect the protective window
(e.g., blast shield) behind the laser aperture. It should be clean and undamaged; replace if needed. There
should be no visible dirt or residue in the optical path of the laser aperture.

Quantitative tasks: Grounding Resistance.

Measure the resistance between the grounding pin of the power cord (if so equipped) and exposed
(unpainted and not anodized) metal on the chassis. Grounding resistance should not exceed 0.5 Ω. If the
unit is double insulated, grounding resistance need not be measured. 

Exposure Duration.

Some laser radiometers can measure pulse duration. If the power meter can react to pulse duration (this
is the preferred circumstance), test the laser at each setting. However, if the radiometer does not measure
pulse duration, use the following less preferable alternative.
Place and secure the laser fiber, handpiece, or micromanipulator with the aiming system focused on the
target material (e.g., black Delrin or a tongue depressor). With the laser set to 10 W and the exposure set
at minimum duration, activate the laser and create a burn. Carefully move the target material to expose a
clean area, maintaining the same distance. Adjust the exposure setting in increments of 0.1 sec or the
next longest duration, and activate the laser at each setting. Continue this process until all exposure
setting have been tested, except continuous. Compare the series of burns to verify that progressively
larger burns occurred as the exposure duration increased.

Repeat Pulse.

If the unit has a repeat pulse feature, which repeats the pulse at a fixed or adjustable rate, test this feature
with the laser set at the minimum, median, and maximum repeat pulse settings. Some laser radiometers
can react quickly enough to be used to test this feature of the laser. With such a radiometer, test the laser
to ensure that the correct power is repeatedly delivered over the correct time period.
If the radiometer cannot be used, use the following alternative test method. Set the laser to about 10 W
and a 0.1 sec exposure duration with the fiber, handpiece, or micromanipulator attached, and verify that
the Repeat Pulse feature operates as expected by moving the Delrin or colored tongue depressor slightly
between each pulse. Be extremely careful to keep hands out of the laser beam path. If the number or
duration between repeat pulses is adjustable, test that setting changes made throughout the range result in
the expected performance. Verify that pulse output is within 10% or that burns of similar density and
size are produced.

Footswitch Exposure Control.

Set the output time for about 5 sec, activate the unit, and release the footswitch after about 1 sec. Verify
that the beam turns off when the footswitch is released.

Power Output.

Select one delivery system (e.g., fiber, handpiece, micromanipulator), and perform the manufacturer's
recommended user calibration procedure. Secure the delivery system at the appropriate distance from the
detector of the laser radiometer to meet spot-size requirements specified in the instructions for the meter.
(Do not focus the beam to a small spot on the laser radiometer. Some laser radiometers require that the
unfocused or a defocused laser beam be projected into the laser radiometer to cover the majority of the
absorber surface. If the laser beam is focused on the detector of such meters, the meter may be damaged.)
WARNING: Accessing the unfocused laser beam may require defeating internal interlocks. Because of
the heightened risk associated with an unfocused, nondiverging laser beam, exercise great care if the
interlocks are to be defeated.
Note: Laser radiometers use different time constants to acquire an acceptable reading. Identify and use
the correct time constant for the radiometer.
Test the laser set at a low (e.g., 10% of full scale), medium (e.g., 50% of full scale), and maximum
output. Activate the laser for a sufficient period to acquire acceptable readings. The measured and
displayed values should be within 10%. If the laser includes a low-power (e.g., mW) feature, test it in a
similar fashion in the radiometer's low-power range. In addition, compare the reading obtained with that
taken during acceptance testing, at the last scheduled inspection, or after the last repair.

Laser Delivery System Calibration.

Some frequency-doubled Nd:YAG surgical lasers include a user-accessible calibration port or radiometer
that allows output calibration and/or testing of the laser fiber. This feature is provided because
transmission of laser energy through a fiber may change as a result of fiber use. Based on the
measurement from the calibration radiometer, the laser may automatically recalibrate itself and/or adjust
displays so that the power indicated to be delivered to the patient will be correct, or it may require the
user to do this manually. Verify that this feature is functioning by using the manufacturer's recommended
calibration procedure to test one delivery system (e.g., fiber, handpiece) that the manufacturer indicates
can be acceptably calibrated using these procedures. A good-quality (e.g., >85% transmissibility,
undamaged sheath) fiber or handpiece should be used for this test.

Preventive Maintenance: General.

Verify that all user preventive maintenance procedures recommended by the manufacturer are carried
out.

Clean.

Clean the exterior. Clean accessible optical components (e.g., blast shield, microscope lenses), if
necessary, using techniques and cleaning solutions recommended by the manufacturer.

Lubricate.

Lubricate any pump, fan, compressor, or printer components as recommended by the manufacturer.

Calibrate/Adjust.

Calibrate any components (e.g., printer) according to the manufacturer's recommendations. Only
appropriately trained personnel should attempt laser adjustments. Ensure that all hoses and tubes are
tight.

Replace.

Replace filters as needed. Check all fluid levels and supplement or replace fluids as needed.