CooperSurgical RUMI II Handle Manual Del Usario página 2

UTERINE POSITIONING
The RUMI II Handle is always intended to be used with the grip in the upward position (see Figure 1).
TO ANTEVERT or insert into an anteverted uterus (see Figure 2): depress the trigger and turn the grip clockwise lifting the
uterus to achieve the desired degree of anteversion, up to 90°. Release the trigger to lock the desired position.
TO RETROVERT or insert into a retroverted uterus (see Figure 3): depress the trigger and turn the grip counterclockwise.
A counterclockwise rotation of the grip will result in the uterus being lowered to a retroverted position down to 50°. Release
the trigger to lock the desired position.
REPROCESSING INSTRUCTIONS FOR THE RUMI II HANDLES
1. INTRODUCTION
This section is intended to provide detailed instructions for effectively processing reusable RUMI II Handles. All reusable
instruments should be thoroughly cleaned and sterilized to prepare them for use.
CooperSurgical, Inc. has validated the processes provided in these instructions to be capable of effective instrument
processing. Equipment, operators, cleaning agents and procedures all contribute to the efficacy of processing. Healthcare
facilities should ensure that selected processing steps are safe and effective within their systems.
Alternative methods of processing these instruments outside the instructions described in this document may be suitable for
reprocessing; however, these have not been evaluated by CooperSurgical, Inc. Operators and healthcare facilities which
choose to perform processes outside the instructions described in this document must validate these processes before use.
In the event that national or regional government requirements conflict with the recommendations provided here, these shall
override the recommendations of CooperSurgical,Inc., but must be validated before use.
Reusable instruments must be rinsed thoroughly after use and after cleaning to ensure removal of gross soil and residual
cleaners and solvents. Gross soil is damaging to instrument surfaces and inhibits thorough cleaning and subsequent
sterilization. Residual cleaners and solvents can impede further processing and may affect the surface finish of the instrument over time.
2. CLEANING
There are two methods for cleaning that have been validated by CooperSurgical, Inc. Any healthcare facility should be able to perform the manual cleaning
process. For those facilities that use automated washer-disinfectors, an automated method has also been validated.
Personnel are cautioned to use personal protective apparel due to the unknown and potentially hazardous nature of biological fluids and soils present. Specific
detergents or cleaning solutions vary in requirements for concentrations and temperatures required for optimal cleaning performance. Use temperatures in
this document as guidance, to be superseded by the detergent/cleaner manufacturer's directions for use. Any processes outside the recommendations in this
document must be validated before use.
The quality of water used to prepare solutions and rinse reusable instruments can affect the efficacy of the process and the instrument reuse life.
CooperSurgical, Inc. recommends the use of freshly prepared purified water or sterile water for dilutions of solution and rinsing of instruments. Non-purified water
can add mineral deposits and recontaminate instruments with microorganisms. Mineral deposits can impede sterilization and affect the condition of the instrument,
resulting in staining, corrosion, and/or other damage.
Equipment and Materials Required for Manual Cleaning
• Personal protective apparel/equipment as recommended by cleaning solution supplier.
• Cleaning bath, sink, or other vessel large enough to accommodate full immersion of instruments.
• Freshly prepared cleaning solution intended for manual cleaning (use enzymatic, neutral, or alkaline detergents).
• Soft-bristled brushes and sponges.
• Clean, low-lint or lint-free cloth.
Equipment and Materials Required for Automated Cleaning
• Personal protective apparel/equipment as recommended by cleaning solution supplier.
• Legally marketed (FDA-cleared and/or CE-marked ) medical device washer or washer-disinfector.
• Cleaning solution intended for automated cleaning (use enzymatic, neutral, or alkaline detergents).
• Racks and accessories to hold and support instruments during processing.
Point of Use
During and immediately after the clinical procedure, instruments should be treated to reduce and remove gross soil materials. Instruments should be wiped
with low-lint or lint-free absorptive materials, such as low-lint or lint-free wipes to remove solid tissues and the majority of bodily fluids. Immediately after use,
all disposable single-use accessories should be removed and discarded into appropriate biohazardous waste containers. Instruments should be placed into a
transport container that will protect them from damage during transport and should be kept moist.
Transport to Processing Area
Transport the instruments to the processing area as soon as practical. Minimize holding time before removing organic debris. Ensure that lighter instruments are
not mixed with heavier instruments to avoid damage to the instruments due to mechanical abrasion. Seal or enclose the transport container to prevent fluid loss
and the potential for cross-contamination of other areas.
Preparation
• Remove all single-use accessories such as the RUMI Tips or Koh Efficient and discard in an appropriate waste container designed for biohazardous
materials if this has not been performed at point of use.
• The only accessory for the RUMI II Handle that is reusable is the Koh Cup. Refer to specific reprocessing instructions included with the Koh Cup device
packaging.
Cleaning
Cleaning should take place as soon after use as practical. Soils should not be allowed to dry onto the instrument surfaces. The manual process and the
automated process were validated independently and are considered equivalently effective when performed according to the instructions in this document.
Do not use metal-bristled brushes on the instruments.
Manual Cleaning Processes
1. Ensure that all single-use tips and colpotomy attachments are removed from the instrument and discarded in an appropriate biohazardous waste container.
2. Detach the Koh Cup from the RUMI II Handle.
3. Prepare a neutral or alkaline enzymatic detergent specifically designed for manual cleaning of medical instruments. Prepare a fresh solution of detergent at
the detergent manufacturer's recommended concentration using water at the detergent manufacturer's recommended temperature.
4. Ensure that the instruments are fully immersed in the prepared solution. Soak the instrument for a minimum of ten (10) minutes at room temperature
(68-77°F/20-25°C) or longer if indicated on the detergent manufacturer's instructions for use.
2
Antevert
Figure 2
Retrovert
Figure 3