INSTRUCTIONS FOR USE
DEVICE DESCRIPTION:
Comfort First, Inc.'s ComfortSpec CS-1100 Speculum Single Use Vaginal Speculum. The Comfort Spec CS-1100 is a one-piece clear cylinder-shaped speculum disposable vaginal speculum.
INTENDED USE:
Vaginal specula are indicated whenever a visual examination of the vagina or cervix is necessary. The instruments are also necessary for visualization of the vagina walls and cervix during pelvic examinations.
CONTRAINDICATIONS:
Refer to hysteroscope or electrosurgical generator manuals.
Warnings and Cautions
WARNING: Inspect each ComfortSpec CS-1100 Speculum box for shipping damage.
WARNING: Inspect speculum prior to use. Do not use if damaged.
WARNING: If a speculum is damaged, do not use any specula from the same case.
WARNING: Specula, when in transit or storage, may be subject to damage beyond the control of the manufacturer or supplier.
WARNING: Never use the speculum with laser equipment.
WARNING: Treat used vaginal specula as biohazardous infectious material. Dispose of used vaginal specula in suitable disposal unit or in accordance with local regulations.
WARNING: The speculum is not compatible with gamma irradiation or autoclave sterilization.
CAUTION: Used by trained personnel only.
CAUTION: Rx Only. U.S. federal law restricts this device to sale by or on the order of a physician, nurse practitioner, or physician assistant.
Warranty
Comfort First, Inc. warrants the speculum to meet Comfort First, Inc. CS-1100 ComfortSpec Speculum specifications for the Product at the time of purchase and to be free from original defects in material and workmanship under normal use and service.
Specula are intended for single use only.
Comfort First should be notified via telephone and/or email of any defective product, and the item should be immediately disposed of in a suitable disposal unit or in accordance with local regulations.
Loss or damage in shipment shall be at the purchaser's risk.
Comfort First, Inc. will not be responsible for loss associated with the use of any Comfort First, Inc. product that has been altered.
THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ANY IMPLIED WARRANTY OR MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE, OR OTHER WARRANTY OF QUALITY, WHETHER EXPRESSED OR IMPLIED. COMFORT FIRST, INC. WILL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES.
Comfort First, Inc. should be notified immediately of any defective units.
MANUFACTURER
Comfort First, Inc. 2225 Lothrop St. Detroit, MI, 48206 1(626) 319-7787
customerservice@comfortfirstinc.com