Bausch & Lomb SofLens daily disposable Contact Lenses - Manual (Page 3)

IMPORTANT:
This package insert has been developed to provide professionals with information covering
characteristics of the Bausch & Lomb SofLens® daily disposable (hilafilcon B) Visibility Tinted
Contact Lens and to illustrate fitting procedures. It is effective as of January 2008 and supersedes
all prior fitting guides for the product described. Please read carefully and keep this information
for future use.
This package insert is intended for the eye care professional, but should be made available to
patients upon request. The eye care professional should provide the patient with the patient
instructions that pertain to the patient’s prescribed lens, and the recommended wearing
schedule.
DESCRIPTION
The Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a
soft hydrophilic contact lens which is available as a spherical lens. The lens is made from the
hilafilcon B material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl
pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This lens is
tinted blue with Reactive Blue Dye 246.
The physical/optical properties of the lens are:
Specific Gravity:
1.119
Refractive Index: 1.4036
Light Transmittance: C.I.E. Y value - approximately 95%
Water Content: 59%
Oxygen Permeability: 22 x 10–11[cm3O2(STP) x cm]/
(sec x cm2 x mmHg) @35˚ C
(Polarographic Method)
The Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens is to be
prescribed for single-use disposable wear.
LENS PARAMETERS AVAILABLE
The Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a
hemispherical shell of the following dimensions:
Diameter:
14.2mm
Center Thickness: 0.05mm to 0.75mm (varies with power)
Base Curve: 8.6mm
Powers (Spherical): +20.00D to -20.00D
HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted
Contact Lens when placed on the cornea acts as a refracting medium to focus light rays on the
retina.
INDICATIONS
The Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens is
indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic
and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less,
that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging
from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each
removal.
CONTRAINDICATIONS (REASONS NOT TO USE)
DO NOT USE the Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted Contact
Lens when any of the following conditions exist:
• Acute and subacute inflammation or infection of the anterior chamber of the eye
• Any eye disease, injury, or abnormality that affects the cornea,conjunctiva, or eyelids
• Severe insufficiency of lacrimal secretion (dry eyes)
• Corneal hypoesthesia (reduced corneal sensitivity)
• Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that may be induced or
exaggerated by wearing contact lenses or use of contact lens solutions
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGS
After a thorough eye examination, including appropriate medical background, patients should
be fully apprised by the prescribing professional of all the risks with contact lens wear. Patients
should be advised of the following warnings pertaining to contact lens wear:
• Problems with contact lenses could result in serious injury to the eye. It is essential that
patients follow their eye care professional’s direction and all labeling instructions for proper
use of lenses. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of
vision.
• Daily wear lenses are not indicated for overnight wear, and patients should be instructed not
to wear lenses while sleeping. Clinical studies have shown that the risk of serious adverse
reactions is increased when daily wear lenses are worn overnight.
• Studies have shown that contact lens wearers who are smokers have a higher incidence of
adverse reactions than nonsmokers.
• If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of the
eye, the patient should be instructed to immediately remove lenses and promptly contact his
or her eye care professional.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investigation of lenses, all refractive
powers, design configurations, or lens parameters available in the lens material are not
evaluated in significant numbers. Consequently, when selecting an appropriate lens design
and parameters, the eye care professional should consider all characteristics of the lens that
can affect lens performance and ocular health, including oxygen permeability, wettability,
central and peripheral thickness, and optic zone diameter.
• The potential impact of these factors on the patient’s ocular health should be carefully
weighed against the patient’s need for refractive correction; therefore, the continuing ocular
health of the patient and lens performance on eye should be carefully monitored by the
prescribing eye care professional.
• Patients who wear aspheric contact lenses, such as the Bausch & Lomb SofLens daily
disposable, to correct presbyopia may not achieve the best corrected visual acuity for either
far or near vision. Visual requirements vary with the individual and should be considered
when selecting the most appropriate type of lens for each patient.
• Eye care professionals should instruct the patient to REMOVE A LENS IMMEDIATELY if an eye
becomes red or irritated.
• Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. The lenses
absorb this dye and become discolored. Whenever fluorescein is used in eyes, the eyes should
be flushed with sterile saline solution that is recommended for in-eye use.
• The patient should be instructed to always discard disposable lenses and lenses worn on a
frequent/planned replacement schedule after the recommended wearing schedule prescribed
by the eye care professional.
• As with any contact lens, follow-up visits are necessary to assure the continuing health of the
patient’s eyes. The patient should be instructed as to a recommended follow-up schedule.
• Aphakic patients should not be fitted with SofLens daily disposable Contact Lenses until the
determination is made that the eye has healed completely.
• The lenses are prescribed for disposable wear, and are to be disposed of once they are
removed from the patient’s eye. It is important that patients be instructed to always have
available a pair of replacement lenses. In the event that a lens must be removed from
the eye because of dust, a foreign body or other contaminant gets on the lens or the lens
becomes dehydrated, the lens should be removed and replaced with a replacement lens.
Eyecare professionals should carefully instruct patients about the following safety precautions. It
is strongly recommended that patients be provided with a copy of the SofLens daily disposable
Patient Information Booklet available from Bausch & Lomb and understand its contents prior to
dispensing the lenses.
Handling Precautions:
• Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions, soaps,
creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before
putting on makeup. Water-base cosmetics are less likely to damage lenses than oil-base
products.
• Be sure that before leaving the eye care professional’s office, the patient is able to remove
lenses promptly or have someone else available to remove them.
• Be certain that the fingers or hands are free of foreign materials before touching lenses, as
microscopic scratches of the lenses may occur, causing distorted vision and/or injury to the
eye.
• Always handle lenses carefully and avoid dropping them.
• Do not touch the lens with fingernails.
• Carefully follow the handling, insertion, removal, cleaning disinfecting, storing and wearing
instructions in the Patient Information Booklet for the SofLens daily disposable Contact Lenses
and those prescribed by the eye care professional.
• Never use tweezers or other tools to remove lenses from the lens container unless specifically
indicated for that use. Pour the lens into the hand.
Topics to Discuss with the Patient:
Who Should Know That the Patient is Wearing Contact Lenses:
• Patients should inform their doctor (health care professional) about being a contact lens
wearer.
• Patients should always inform their employer of being a contact lens wearer. Some jobs may
require the use of eye protection equipment or may require that you do not wear lenses.
ADVERSE REACTIONS
The patient should be informed that the following problems may occur:
• Eyes stinging, burning, itching (irritation), or other eye pain
• Comfort is less than when lens was first placed on eye
• Abnormal feeling of something in the eye (foreign body, scratched area)
• Excessive watering (tearing) of the eyes
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (poor visual acuity)
• Blurred vision, rainbows, or halos around objects
• Sensitivity to light (photophobia)
• Dry eyes
If the patient notices any of the above, he or she should be instructed to:
• Immediately remove lenses.
• If the discomfort or problem stops, then look closely at the lens. If the lens is in any way
damaged, do not put the lens back on the eye. Place the lens in the storage case and contact
the eye care professional. If the lens has dirt, an eyelash, or other foreign body on it, or the
problem stops and the lens appears undamaged, the patient should insert a new lens. After
insertion of a new lens, if the problem continues, the patient should immediately remove the
lenses and consult the eye care professional.
If the above symptoms continue after removal of the lens, or upon insertion of a new lens, the
patient should immediately remove the lenses and contact his or her eye care professional
or physician, who must determine the need for examination, treatment or referral without
delay. (See Important Treatment Information for Adverse Reactions.) A serious condition such
as infection, corneal ulcer, corneal vascularization, or iritis may be present, and may progress
rapidly. Less serious reactions such as abrasions, epithelial stinging or bacterial conjunctivitis
must be managed and treated carefully to avoid more serious complications.
Important Treatment Information for Adverse Reactions
Sight-threatening ocular complications associated with contact lens wear can develop rapidly, and
therefore early recognition and treatment of problems are critical. Infectious corneal ulceration is
one of the most serious potential complications, and may be ambiguous in its early stage. Signs
and symptoms of infectious corneal ulceration include discomfort, pain, inflammation, purulent
discharge, sensitivity to light, cells and flare and corneal infiltrates.
Initial symptoms of a minor abrasion and an early infected ulcer are sometimes similar.
Accordingly, such epithelial defect, if not treated properly, may develop into an infected ulcer.
In order to prevent serious progression of these conditions, a patient presenting symptoms
of abrasions or early ulcers should be evaluated as a potential medical emergency, treated
accordingly, and be referred to a corneal specialist when appropriate. Standard therapy for
corneal abrasions such as eye patching or the use of steroids or steroid/antibiotic combinations
may exacerbate the condition. If the patient is wearing a contact lens on the affected eye when
examined, the lens should be removed immediately and the lens and lens care products retained
for analysis and culturing.
SELECTION OF PATIENTS
The eye care professional should not fit patients who cannot or will not adhere to the
replacement regimen for Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted
Contact Lenses or are unable to place and remove the lenses should not be provided with them.
Failure to follow handling instructions could lead to serious eye infections which might result in
corneal ulcers.
Patient communication is vital because it relates not only to patient selection but also to ensure
compliance. It is also necessary to discuss the information contained in the Patient Information
Booklet with the patient at the time of the initial examination.
Patients selected to wear Bausch & Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted
Contact Lenses should be chosen for their motivation to wear contact lenses, general health and
cooperation. The eye care professional must take care in selecting, examining and instructing
contact lens patients. Patient hygiene and willingness to follow the eye care professional
instructions are essential to their success.
A detailed history is crucial to determining patient needs and expectations. Your patient should
be questioned regarding vocation, desired lens wearing time (full or part time), and desired lens
usage (reading, recreation or hobbies).
Initial evaluation of the lens should be preceded by a complete eye examination, including
visual acuity with and without correction at both distance and near, keratometry and slit lamp
examination.
It is normal for the patient to experience mild symptoms such as lens awareness, variable vision,
occasional tearing (watery eyes) and slight redness during the adaptation period. Although the
adaptation period varies for each individual, generally within one week these symptoms will
disappear. If these symptoms persist, the patient should be instructed to contact his or her eye
care professional.
FITTING PROCEDURE
1. Pre-fitting Examination
A pre-fitting patient history and examination are necessary to:
• determine whether a patient is a suitable candidate for daily wear contact lenses (consider
patient hygiene and mental and physical state),
• make ocular measurements for initial contact lens parameter selection, and
• collect and record baseline clinical information to which post-fitting examination results can
be compared.
A pre-fitting examination should include spherocylinder refraction and VA, keratometry, and
biomicroscopic examination.
2. Initial Lens Power Selection
a. Lens power is determined from the patient’s spherical equivalent prescription corrected to the
corneal plane.
b. Select the appropriate power lens and place the lens on the eye. Allow the lens to remain on
the eye long enough (10 to 20 minutes) to achieve a state of equilibrium. Small variations
in the tonicity, pH of the lens solutions, and individual tear composition may cause slight
changes in fitting characteristics.
c. Allow any increase in tear flow to subside before evaluating the lens. The time required will
vary with the individual.
3. Initial Lens Evaluation
a. To determine proper lens parameters observe the lens relationship to the eye using a slit
lamp
• Movement: The lens should provide discernible movement with:
—Primary gaze blink
—Upgaze blink
—Upgaze lag
• Centration: The lens should provide full corneal coverage.
b. Lens evaluation allows the contact lens fitter to evaluate the lens/cornea relationship in the
same manner as would be done with any soft lens.
4. Criteria of a Well-Fitted Lens
If the initial lens selection fully covers the cornea, provides discernible movement after a blink,
is comfortable and provides satisfactory visual performance, it is a well fitted lens and can be
dispensed.
5. Characteristics of a Tight (Steep) Lens
A lens which is much too steep may subjectively and objectively cause distortion which will
vary after a blink. However, if a lens is only marginally steep, the initial subjective and objective
vision and comfort findings may be quite good. A marginally steep lens may be differentiated
from a properly fitted lens by having the patient gaze upward. A properly fitted lens will tend
to slide downward approximately 0.5mm while a steep lens will remain relatively stable in
relationship to the cornea, particularly with the blink.
6. Characteristics of a Loose (Flat) Lens
If the lens is too flat, it will:
— Decenter, especially on post-blink.
— Have a tendency to edge lift inferiorly and sit on the lower lid, rather than positioning
between the sclera and palpebral conjunctiva.
— Have a tendency to be uncomfortable and irritating with fluctuating vision.
— Have a tendency to drop or lag greater than 2.0mm on upgaze post-blink.
7. Follow-up Care
a. Follow-up examinations are necessary to ensure continued successful contact lens wear. From
the day of dispensing, the following schedule is a suggested guideline for follow up.
• 3 or 4 days post-dispensing
• 10 days
• 1 month
• 3 months
• every six months thereafter
At the initial follow-up evaluations the eye care professional should again reassure the patient
that any of the previously described adaptive symptoms are normal, and that the adaptation
period should be relatively brief.
b. Prior to a follow-up examination, the contact lenses should be worn for at least 4 continuous
hours and the patient should be asked to identify any problems which might be occurring
related to contact lens wear.
c. With lenses in place on the eyes, evaluate fitting performance to assure that CRITERIA OF A
WELL-FITTED LENS continue to be satisfied. Examine the lenses closely for surface deposition
and/or damage.
d. After the lens removal, instill sodium fluorescein [unless contraindicated] into the eyes and
conduct a thorough biomicroscopy examination.
1. The presence of vertical corneal striae in the posterior central cornea and/or corneal
neovascularization may be indicative of excessive corneal edema.
2. The presence of corneal staining and/or limbal-conjunctival hyperemia can be indicative
of an unclean lens, a reaction to solution preservatives, excessive lens wear, and/or a
poorly fitting lens.
3. Papillary conjunctival changes may be indicative of an unclean and/or damaged lens.
If any of the above observations are judged abnormal, various professional judgments are
necessary to alleviate the problem and restore the eye to optimal conditions. If the CRITERIA OF
A WELL-FITTED LENS are not satisfied during any follow-up examination, the patient should be
re-fitted with a more appropriate lens.
PROFESSIONAL FITTING SETS
Lenses must be discarded after single use and must not be used from patient to patient.
WEARING SCHEDULE
The wearing and replacement schedules should be determined by the eye care professional.
Regular checkups, as determined by the eye care professional, are extremely important.
Daily Wear:
There may be a tendency for the daily wear patient to over wear the lenses initially. Therefore,
the importance of adhering to a proper, initial daily wearing schedule should be stressed to these
patients. The wearing schedule should be determined by the eye care professional. The wearing
schedule chosen by the eye care professional should be provided to the patient. The lens is to be
prescribed for single-use disposable wear, and is to be discarded after each removal.
MONOVISION FITTING GUIDELINES
1. Patient Selection
A. Monovision Needs Assessment
For a good prognosis the patient should have adequately corrected distance and near visual
acuity in each eye. The amblyopic patient or the patient with significant astigmatism (greater
than one [1] diopter) in one eye may not be a good candidate for monovision with the Bausch &
Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lenses Contact Lens.
Occupational and environmental visual demands should be considered. If the patient requires
critical vision (visual acuity and stereopsis) it should be determined by trial whether this patient
can function adequately with monovision. Monovision contact lens wear may not be optimal for
such activities as:
(1) visually demanding situations such as operating potentially dangerous machinery or
performing other potentially hazardous activities; and
(2) driving automobiles (e.g., driving at night). Patients who cannot pass their state drivers
license requirements with monovision correction should be advised to not drive with this
correction, OR may require that additional over-correction be prescribed.
B. Patient Education
All patients do not function equally well with monovision correction. Patients may not perform
as well for certain tasks with this correction as they have with bifocal reading glasses. Each
patient should understand that monovision, as well as other presbyopic contact lenses, or other
alternative, can create a vision compromise that may reduce visual acuity and depth perception
for distance and near tasks. During the fitting process it is necessary for the patient to realize the
disadvantages as well as the advantages of clear near vision in straight ahead and upward gaze
that monovision contact lenses provide.
2. Eye Selection
Generally, the non-dominant eye is corrected for near vision. The following test for eye
dominance can be used.
A. Ocular Preference Determination Methods
Method 1— Determine which eye is the “sighting dominant eye.” Have the patient point to an
object at the far end of the room. Cover one eye. If the patient is still pointing directly
at the object, the eye being used is the dominant (sighting) eye.
Method 2— Determine which eye will accept the added power with the least reduction in vision.
Place a trial spectacle near add lens in front of one eye and then the other while the
distance refractive error correction is in place for both eyes. Determine whether the
patient functions best with the near add lens over the right or left eye.
B. Refractive Error Method
For anisometropic corrections, it is generally best to fit the more hyperopic (less myopic) eye for
distance and the more myopic (less hyperopic) eye for near.
C. Visual Demands Method
Consider the patient’s occupation during the eye selection process to determine the critical
vision requirements. If a patient’s gaze for near tasks is usually in one direction correct the eye
on that side for near.
Example: A secretary who places copy to the left side of the desk will usually function best with
the near lens on the left eye.
3. Special Fitting Considerations
Unilateral Lens Correction
There are circumstances where only one contact lens is required. As an example, an emmetropic
patient would only require a near lens while a bilateral myope may require only a distance lens.
Example: A presbyopic emmetropic patient who requires a +1.75 diopter add would have a +1.75
lens on the near eye and the other eye left without a lens.
A presbyopic patient requiring a +1.50 diopter add who is -2.50 diopters myopic in the right eye
and -1.50 diopters myopic in the left eye may have the right eye corrected for distance and the
left uncorrected for near.
4. Near Add Determination
Always prescribe the lens power for the near eye that provides optimal near acuity at the
midpoint of the patient’s habitual reading distance. However, when more than one power
provides optimal reading performance, prescribe the least plus (most minus) of the powers.
5. Trial Lens Fitting
A trial fitting is performed in the office to allow the patient to experience monovision correction.
Lenses are fit according to the directions in the general fitting guidelines.
Case history and standard clinical evaluation procedure should be used to determine the
prognosis. Determine which eye is to be corrected for distance and which eye is to be corrected
for near. Next determine the near add. With trial lenses of the proper power in place observe the
reaction to this mode of correction.
Immediately after the correct power lenses are in place, walk across the room and have the
patient look at you. Assess the patient’s reaction to distance vision under these circumstances.
Then have the patient look at familiar near objects such as a watch face or fingernails. Again
assess the reaction. As the patient continues to look around room at both near and distance
objects, observe the reactions. Only after these vision tasks are completed should the patient be
asked to read print. Evaluate the patient’s reaction to large print (e.g. typewritten copy) at first
and than graduate to news print and finally smaller type sizes.
After the patient’s performance under the above conditions are completed, tests of visual acuity
and reading ability under conditions of moderately dim illumination should be attempted.
An initial unfavorable response in the office, while indicative of a guarded prognosis, should
not immediately rule out a more extensive trial under the usual conditions in which a patient
functions.
6. Adaptation
Visually demanding situations should be avoided during the initial wearing period. A patient
may at first experience some mild blurred vision, dizziness, headaches, and a feeling of slight
imbalance. You should explain the adaptational symptoms to the patient. These symptoms may
last for a brief minute or for several weeks. The longer these symptoms persist, the poorer the
prognosis for successful adaptation.
To help in the adaptation process the patient can be advised to first use the lenses in a
comfortable familiar environment such as in the home.
Some patients feel that automobile driving performance may not be optimal during the
adaptation process. This is particularly true when driving at night. Before driving a motor vehicle,
it may be recommended that the patient be a passenger first to make sure that their vision is
satisfactory for operating an automobile. During the first several weeks of wear (when adaptation
is occurring), it may be advisable for the patient to only drive during optimal driving conditions.
After adaptation and success with these activities, the patient should be able to drive under
other conditions with caution.
7. Other Suggestions
The success of the monovision technique may be further improved by having your patient follow
the suggestions below.
— Having a third contact lens (distance power) to use when critical distance viewing is needed.
— Having a third contact lens (near power) to use when critical near viewing is needed.
— Having supplemental spectacles to wear over the monovision contact lenses for specific visual
tasks may improve the success of monovision correction. This is particularly applicable for
those patients who cannot meet state licensing requirements with a monovision correction.
— Make use of proper illumination when carrying out visual tasks.
Success in fitting monovision can be improved by the following suggestions:
— Reverse the distance and near eyes if a patient is having trouble adapting.
— Refine the lens powers if there is trouble with adaptation.
Accurate lens power is critical for presbyopic patients.
— Emphasize the benefits of the clear near vision in straight ahead and upward gaze with
monovision.
* The decision to fit a patient with a monovision correction is most appropriately left to the
eye care professional in conjunction with the patient after carefully considering the patient’s
needs.
* All patients should be supplied with a copy of the SofLens daily disposable (hilafilcon B)
Visibility Tinted Contact Lens Patient Information Booklet.
HANDLING OF LENSES
Patient Lens Care Directions:
When lenses are dispensed, the patient should be provided with appropriate and adequate
instructions and warnings for lens care handling. The eye care professional should recommend
appropriate and adequate procedures for each individual patient in accordance with the particular
lens wearing schedule.
CARE FOR A STICKING (NONMOVING) LENS
If the lens sticks (stops moving), the patient should be instructed to use a lubricating or
rewetting solution in their eye. The patient should be instructed to not use plain water, or
anything other than the recommended solutions. The patient should be instructed to contact the
eye care professional if the lens does not begin to move upon blinking after several applications
of the solution, and to not attempt to remove the lens except on the advice of the eye care
professional.
EMERGENCIES:
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are
splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH TAP WATER AND THEN REMOVE
LENSES PROMPTLY. CONTACT YOUR EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM
WITHOUT DELAY.
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing Bausch &
Lomb SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lenses or experienced with
the lenses should be reported to:
Bausch & Lomb Incorporated
Rochester, New York 14609
Toll Free Telephone Number
In the Continental U.S., Alaska, Hawaii
1-800-828-9030
In New York State
1-800-462-1720
In Canada
1-888-459-5000
HOW SUPPLIED
Each sterile lens is supplied in a plastic package containing borate buffered saline solution with
poloxamine. Each container is marked with the manufacturing lot number of the lens, diopter
power, and expiration date.
SyMBOL REFERENCE GUIDE FOR LABEL AND CARTONS
Quality System Certification symbol
Fee paid for waste management
Sterile using steam or dry heat
See instruction leaflet
Diameter
Use by date (expiration date)
Batch code
Diopter (lens power)
Authorized representative in European community
Caution: Federal (U.S.A.) law restricts this device to
sale by or on the order of a licensed practitioner.
Base curve
Single Use Only
1 2 3 4 5 6 7 8 9 10 11