Welch Allyn Vaginal Specula User Manual

Product #

Electrosurgical Specula L x W

Pederson

88350 Medium 114mm x 22mm

88352 Large 121mm x 26mm

Graves

88346 Medium 113mm x 33mm

88348 Large 125mm x 35mm

Prima Series

®

88338 Medium 113mm x 33mm

88340 Large 125mm x 35mm

INSTRUCTIONS FOR USE

Vaginal Specula

Part # 883383 Revision A

Skaneateles Falls, NY 13153 USA

Phone: [phone]

Toll Free: 800-535-6663

Fax: [phone]

Skaneateles Falls, NY 13153 USA

Phone: [phone]

Toll Free: 800-535-6663

Fax: [phone]

Manufactured for:

Manufactured for:

DESCRIPTION

Vaginal specula are available from Welch Allyn’s line that allow use in almost any situation.

There are single-use and re-usable plastic specula for general office or operating room use, as well as Rose

and Prima Series

™

electrosurgical specula. All of the rose-coated and Prima

™

specula are non-conductive and

autoclavable. Many of the styles include either permanent or disposable smoke evacuator tubing.

INDICATIONS FOR USE

Vaginal specula are indicated whenever a visual examination of the vagina and 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 and 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 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, electrosurgical, cryo or cold knife treatment methods.

7 Follow-up evaluation of treatment of cervical or vaginal lesions.

8 Preoperative 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.

WARNINGS

Inform the patient when the speculum is introduced and removed.

Adjust as necessary to provide improved comfort.

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ETHYLENE OXIDE

n Thorouthly clean specula of all foreign matter prior to sterilization, following steps A and B.

n Follow the manufacturer’s instructions for operation and loading of sterilizer.

During sterilization provide direct exposure to all surfaces of the instruments.

n Sterilize instruments in their “open” position.

n Avoid contact of plastic to bare metal.

RECOMMENDED HOSPITAL EHTYLENE OXIDE CYCLE

Temperature 125-130°F

50% RH (pre-humidity) 60 minutes

-0/+10 minutes

Pre Vacuum 24” Hg ± 2” Hg

Gas Pressure 6-8 psig (550-660 mg/L)

Exposure Time 4 hours -0/+0.25 hours

Post Vacuum 24” Hg 2X ± 2” Hg

Aeration 12-0/+1 hours at 120°F

PRECAUTIONS

The size and shape of the speculum is determined by the patient’s anatomy and need for

surgical procedure. For example, electrosurgery and laser procedures require special instrumentation

and that is not interchangeable. Injury to the patient or examiner can occur if the proper

speculum is not used. The following are some of the recommendations for the use of the

various types of specula.

1 Stainless steel, disposable or reusable plastic

General Exam Colposcopy

Cervical Polypectomy Bipolar Cauterization

Endometrial Biopsy Hysterography

Cryosurgery Conization

2 Prima Series

™

and Rose Coated, specula monopolar electrosurgical

procedures (verify patient is grounded), e.g. electrosurgical procedures

Check the surfaces and coating of these instruments for smoothness and is intact prior to their use.

If any flaws are seen, do not use the instrument. Insert smoke evacuation tubing prior to use in

electrosurgical procedures. It is possible to use these instruments wherever stainless steel specula

are indicated.

Note: Coating wear at pivot points is considered normal in everyday use.

Take care during the procedure to avoid contact with these areas.

3 Laser required in non-reflective procedures i.e. laser.

DIRECTION FOR USE

The size and type of speculum is determined by the patients’ anatomy and planned need

for the 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 forchette. 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. Do not force the introduction of a speculum and verify placement is not 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. Use lubrication if no cytology or colposcopic exam was done.

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STORAGE

Store instruments in a dry, moisture-free area. Store the instruments in a protective tray with partitions.

Protect with cloth or gauze if stored in drawers.

STERILIZATION

Steam Autoclave Sterilization

n Thoroughly clean the instrument of all foreign matter prior to sterilization.

n Follow the manufacturer’s instructions for operation and loading of steam autoclave.

n Direct steam exposure to all surfaces of the instrument during sterilization is required.

n Autoclave temperatures should not exceed 280°F (137°C); pressure should not

exceed 32 p.s.i. (2.2 atmospheres).

n Standard cycle of 270°F (132°C) for 10 minutes will vary depending on autoclave

model, autoclave size, load size, and load configuration.

Allow longer times for lower temperatures. Allow instruments to cool down from

autoclave to room temperature. Do not immerse in any fluid until the instrument has

been allowed to cool.

Gravity Displacement Cycles

270°—275°F / 10-15 minutes or

250°F / 15-30 minutes

Prevacuum Cycles

270°—275°F / 3-4 minutes

CARE

Thorough maintenance will ensure proper function of these instruments. It is important to

clean and sterilize each instrument immediately after each procedure. Proper maintenance

will also extend the life of the instrument.

n Handle each instrument individually. Do not handle in groups or stacks.

n Keep track of all components when disassembling. Place in tray or tub

corresponding to the instrument. Do not interchange components.

n Keep replacement instruments on hand. Damage to movable parts can

result in substandard performance of the instrument.

n Inspect instruments for integrity of movable parts (jaws, hinges, etc.), signs of

damage (broken or cracked) or missing hardware (screws).

n Check insulation for cuts, voids, cracks, tears, abrasions, etc. on

electrosurgical instruments.

CLEANING

Rinsing and cleaning must take place immediately following the instrument’s use for

decontamination. Adherent particles may resist cleaning or cause staining. Completely clean

instruments 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.

n Follow the instructions under “care” for proper handling of the instruments.

n Wear protective gloves during the cleaning procedure.

n Never use a corrosive cleaning agent (i.e. bleach).

n Fully immerse instruments in cleaning agent.

n Never use a glass sterilizer with electrosurgical or Prima Series

™

instruments.

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.

B Cleaning Agents and Equipment

n Cleaning agents and rinses at or near a neutral pH (7.0) are recommended.

n Use warm water and a mild soap.

n Do not use an abrasive cleaning solution.

n Use a soft bristle brush (toothbrush type).

n Use round bristle brushes to clean inside channels of smoke tubes.

n An enzymatic cleaner is recommended to remove protein deposits on the

instrument. Follow enzymatic manufacturer’s instructions and rinse thoroughly.

Note: Soak and thoroughly rinse the instruments in warm tap water to remove

cleaning agents. A final rinse in distilled water is recommended.

3

C Cleaning Method (after each use)

1 Rinse and/or pre-soak.

2 Manually clean with brushes using a mild soap and warm water.

3 Using a round bristle brush, clean inside the tip channel as follows:

A Warm water B Cleaning agent C Warm water

4 Rinse.

5 Enzymatic cleaner.

6. Rinse.

7 Dry with cloth or gauze and compressed air.

8 Inspection.

9 Prepare for storage and/or sterilization.

Note: Dry instruments completely with compressed air (including inside channels) and/or a dry

oven (maximum temperature 280°F).

Special Electrosurgical Instrument Cleaning

1 Rose Coated instruments are permanently stained by Lugol’s unless they are

immediately cleaned with StainEnder

™

or a similar solution after use. Although stain

resistant, Prima Series

™

specula are stained by Lugol’s, therefore clean in a similar fashion.

2 Wash the instruments immediately after use with hot soapy water. Rinse with hot

water. To minimize the potential of contaminating the StainEnder

™

solution,

use disinfectant prior to inserting them into the cleaning solution.

3 Completely immerse the instrument in undiluted StainEnder

™

. Allow the instruments

to soak until all stains are removed. Lugol’s not immediately removed from the

instrument may either require additional soaking time or result in permanent staining.

Any permanent Lugol stains will appear as a whitish residue after autoclaving.

D Sterilization with an Approved Liquid Chemical Sterilant

Thoroughly clean instruments following steps A,B and C, prior to cold sterilization. Use cold

soak solutions with 2% glutaraldehyde solution for sterilizing the instruments. Fully immerse

instruments. Follow the manufacturer’s instructions for sterilization times. Soak and rinse

thoroughly in two separate sterile, deionized water baths. Dry instruments.

E Reassembly

Reassemble the yoke to the remainder of the speculum assembly using the knurled

nut removed earlier.

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