DESCRIPTION
The latex free,
Prima Series
®
Vaginal reusable
specula offers an ideal instrument solution for
almost any situation. The
Prima Series
specula,
available in two sizes [PSV-1L (medium) and PSV-
2L (large)], can be utilized for general office or
operating room procedures, as well as for any
procedures that require non-conductive properties.
The
Prima Series
specula are non-conductive and
can be sterilized in an autoclave.
WARNINGS
•
To avoid electric shock to patient and/or user, use only plastic
or coated specula instruments during a LEEP (electrosurgical)
procedure.
•
The patient should be informed when the speculum is to be
introduced and removed. Adjustments may be necessary to
provide improved comfort.
CAUTION
•
U.S. Federal Law restricts this device to sale by or on the
order of a physician.
•
NON-STERILE: Sterilize before use.
INDICATIONS FOR USE
Vaginal specula are indicated whenever a visual examination of
the vagina or cervix is necessary. The instruments are also
necessary for visualization when treating vaginal/cervical lesions.
Some of the indications include (not a complete list):
1.
General pelvic exam—visualization of the cervix or
vagina, and for obtaining pap smears.
2.
Visualization of cervical or vaginal secretions for obtaining
cultures or wet smears.
3.
Visualization for evaluation of the source of bleeding:
vaginal, cervical, or uterine.
4.
Evaluation of the vagina and/or cervix in presence of
vulvar or perineal viral (Herpes or HPV) lesions.
5.
Visualization of cervix and/or vagina as part of evaluation
and treatment of CIN; abnormal pap, VAIN, HPV or other
cervical lesions.
6.
In conjunction with biopsy, LEEP (non-conductive), cryo
or cold knife treatment methods.
7.
Follow-up evaluation of treatment of cervical or
vaginal lesions.
8.
Pre-operative evaluation of vaginal and uterine supports
relating to descent and prolapse.
9.
Post-operative evaluation of vaginal apex after abdominal
or vaginal hysterectomy.
10.
Post-operative evaluation after vaginal or abdominal
pelvic relaxation surgical procedures.
CONTRAINDICATIONS
Please refer to hysteroscope or electrosurgical generator
manuals.
PRECAUTIONS
The size and shape of the speculum is determined by the
patient’s anatomy and need for surgical procedure. For example,
LEEP and laser procedures require special instrumentation and
cannot be interchanged. Injury to the patient or examiner can
occur if the proper speculum is
not used.
The following are some recommendations for the use of the
various types of specula:
■ Stainless steel or reusable plastic
•
General Exam
•
Colposcopy
•
Cervical Polypectomy
•
Bipolar Cauterization
•
Endometrial Biopsy
•
Hysterography
•
Cryosurgery
•
Conization
■
Prima Series
must be used during LEEP/LLETZ procedures
(monopolar electrosurgical procedures) when the patient
must be grounded.
The surfaces of these specula should be checked for
smoothness and intactness prior to their use. If any flaws
are seen, do not use the instrument. Smoke evacuation tubing
should be inserted prior to use in LEEP procedures.
These specula can also be used wherever stainless steel or
coated specula are indicated.
DIRECTION FOR USE
Sterilize Specula Before Use
The size and type of speculum is determined by the patients’
anatomy and intended use of the instrument. With the patient in
the lithotomy position, a warmed speculum is inserted, usually
without lubrication, in a horizontal fashion holding the instrument
in the dominant hand while the 2nd and 3rd fingers of the non-
dominant hand spread the labia minora and slightly depress the
posterior fourchette. The speculum is gently advanced partially
opened until the cervix is clearly visualized. The speculum is then
opened more fully and fixed with the blade and handle locks
allowing for optimum visualization and patient comfort. The
introduction of a speculum cannot be forced and should not be
painful.
After visualization and completion of the examination or vaginal
surgical procedure(s), the locks are loosened, the speculum
slightly opened further, and then released as the instrument is
gently removed. Lubrication may be used if no cytology or
colposcopic exam will be done.
CARE
Thorough maintenance will ensure proper function of these
specula. It is important to clean and sterilize each instrument
immediately after each procedure. Proper maintenance will also
extend the life of the instrument.
•
Handle each specula individually. Do not handle in groups or
stacks.
•
Keep track of all components when disassembling. Place in
tray or tub corresponding to the specula.
Do not interchange components.
•
Inspect specula for integrity of movable parts (jaws, hinges,
etc.), signs of damage (broken or cracked) or missing hardware
(screws). Replacement parts should be kept on hand. Damage
to movable parts can result in sub-standard performance of the
specula.
•
Check insulation for cuts, voids, cracks, tears, abrasions, etc.
on LEEP or coated specula to be used with an ESU
(electrosurgical unit).
CLEANING
Rinsing and cleaning must take place immediately following the
instrument’s use for decontamination. Adherent particles may resist
cleaning or cause staining. Instruments are to be completely
cleaned of all foreign matter with special attention focused on
channels and movable parts (e.g. smoke tube) in contact with body
tissue and fluid. Thorough cleaning is essential prior to sterilization.
•
Follow the instructions under “CARE” for proper handling of
the instruments.
•
Wear protective gloves during the cleaning procedure.
•
Never use a corrosive cleaning agent (i.e. bleach).
•
Fully immerse instruments in cleaning agent.
•
Never use a glass sterilizer with LEEP or
Prima Series
specula.
A
Disassembly
Remove knurled nut holding the yoke/upper assembly to
lower bill. Separate the two. If disposable smoke tubing was
used, remove tubing and discard per local hazardous waste
procedures.
B
Cleaning Agents and Equipment
•
Cleaning agents and rinses at or near a neutral pH (7.0)
are recommended.
•
Use warm water and a mild soap.
•
Do not use an abrasive cleaning solution.
•
A soft bristle brush (toothbrush type) should be used.
•
Round bristle brushes should be used to clean inside
channels of smoke tube connector.
•
An enzymatic cleaner is recommended to remove protein
deposits on the specula. Follow the manufacturer’s
instructions and rinse thoroughly.
Note:
Soak and thoroughly rinse the specula in warm tap water
to remove cleaning agents. A final rinse in distilled water is
recommended.
35634-DFU • Rev. A • 7/14
PSV-1L and PSV-2L •
Prima Series
®
Vaginal LEEP Specula
Directions for Use (English)
