PureWick™ Flex Female External Catheter
Indications:
The PureWick™ Flex Female External Catheter is intended for non-invasive urine output management in adult users with female anatomy, for conditions such as urinary incontinence.
Contraindications:
Users with urinary retention
Warnings:
The PureWick™ Flex Female External Catheter is designed for single-use only. Trying to wash, sanitize or reuse it may lead to risk of infection or illness. This may damage the product and materials. The product may not work and cause injury or illness. To avoid potential skin injury, never push or rub the product against the skin during placement or removal. Do not block airflow to the product (e.g., blocking the vent hole, bedpan, barrier creams) Do not insert the product into vagina, anus, or other body orifice. Stop use if an allergic reaction occurs. After use, this product may be a potential biohazard. Dispose of in accordance with applicable local, state, and federal laws and regulations. Do not use on users with frequent episodes of stool incontinence without a fecal management system in place. Do not use on users with skin irritation or breakdown at the site. Use with caution on users who had recent surgery of the external female anatomy. Do not use on users with moderate/heavy menstruation who cannot use a tampon.
Precautions:
Use with caution on users who are agitated, combative or uncooperative and might remove the product. Do not use barrier cream on the surfaces where the product will be placed. Barrier cream may reduce suction. Keep suction on while removing the product. This helps prevent leaks during removal.
PureWick™ Female External Catheter
Indications:
The PureWick™ Female External Catheter is intended for non-invasive urine output management in female patients.
Contraindications:
Patients with urinary retention
Warnings:
Do not use the PureWick™ Female External Catheter with bedpan or any material that does not allow for sufficient airflow. To avoid potential skin injury, never push or pull the PureWick™ Female External Catheter against the skin during placement or removal. Never insert the PureWick™ Female External Catheter into vagina, anal canal, or other body cavities. Discontinue use if an allergic reaction occurs. After use, this product may be a potential biohazard. Dispose of in accordance with applicable local, state and federal laws and regulations.
MRI Warnings •
Always disconnect the PureWick™ Flex Female External Catheter from wall suction or the PureWick™ Urine Collection System prior to an MRI procedure. • It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely. Any deviation may result in injury to the user. • Non-clinical testing demonstrated that the PureWick™ Flex Female External Catheter is MR Conditional. A user with one of these PureWick™ Flex Female External Catheters can be scanned safely under the following conditions:
• Static magnetic field of 1.5-Tesla or 3-Tesla only • Maximum spatial gradient magnetic field of 40-T/m (4000-Gauss/cm) • Maximum MR system reported whole body averaged specific absorption rate (SAR) of 2-W/kg for up to 60 minutes of continuous scanning in the Normal Operating Mode • Under the scan conditions defined, the PureWick™ Flex Female External Catheter is expected to produce a maximum temperature rise of 1.5 degrees Celsius after 15-minutes of continuous scanning. • There are no circularly polarized (quadrature-driven) RF coil restrictions.
Precautions:
Not recommended for patients who are: Agitated, combative, or uncooperative and might remove the PureWick™ Female External Catheter. Having frequent episodes of bowel incontinence without a fecal management system in place. Experiencing skin irritation or breakdown at the site. Experiencing moderate/heavy menstruation and cannot use a tampon. Do not use barrier cream on the perineum when using the PureWick™ Female External Catheter. Barrier cream may impede suction. Proceed with caution in patients who have undergone recent surgery of the external urogenital tract. Always assess skin for compromise and perform perineal care prior to placement of a new PureWick™ Female External Catheter. Maintain suction until the PureWick™ Female External Catheter is fully removed from the patient to avoid urine backflow.
PureWick™ Male External Catheter
Indications:
The device is intended for non-invasive urine output management, such as urinary incontinence, in users with male anatomy.
Contraindications:
Users with urinary retention
Warnings:
Do not use on irritated skin. Examples include, but are not limited to, rashes, skin tears, or blisters. Do not cover fresh surgical wounds with the device. Do not use the device with any material or in any position that blocks the vents on the front of the device or does not allow for airflow through the device. Examples include, but are not limited to, tight clothing or briefs. To avoid potential skin injury, never pull the device directly away from the user. Always peel in the direction from head to foot. Stop use if an allergic reaction occurs. After use, this product may be a potential biohazard. Dispose of in accordance with applicable local, state, and federal laws and regulations.
Precautions:
Not recommended for patients who are: Agitated, combative, or uncooperative and might remove the PureWick™ Male External Catheter. Having frequent episodes of bowel incontinence without a fecal management system in place. Experiencing skin irritation or breakdown at the site. Do not use barrier creams, lotions, or ointments on the penis or pubic skin around the base of the penis when using the device. These may impede suction or weaken adhesive. Proceed with caution in users who have had recent surgery of the external male anatomy. Always check skin for irritation or breakdown and clean and dry the skin prior to placement of a new device.
PureWick™ Urine Collection System
Indications:
The PureWick™ Urine Collection System is to be used with the PureWick™ External Catheters which are intended for non-invasive urine output management.
Contraindications:
Do not use the PureWick™ Urine Collection System with PureWick™ External Catheters on individuals with urinary retention.
Safety and Warnings:
Always unplug PureWick™ Urine Collection System before cleaning or when not in use. Do not immerse the PureWick™ Urine Collection System in water. As with most electrical devices, electrical parts in this system are electrically live even when the power is off. To reduce the risk of electric shock, if the PureWick™ Urine Collection System falls into water, unplug immediately. Do not reach into the water to retrieve it. Contains small parts that may cause choking. Keep out of reach of children. Keep cords and tubing out of the reach of children to avoid the risk of strangulation. Discontinue use if an allergic reaction occurs. Not recommended for users who are experiencing skin irritation or skin breakdown in device contact areas. WARNING: This device should not be used in oxygen rich environments or in conjunction with flammable anesthetics. If the PureWick™ Urine Collection System is dropped or tipped over spilling urine, unplug the unit and carefully inspect for loose or damaged parts before resuming use. Contact Customer Support at 1-855-914-2935 if any damage is observed. The pump tubing connecting the PureWick™ Urine Collection System to the collection canister may experience light condensation inside the tube. This is not unusual and does not affect function. However, if urine or water has streamed into the pump, discontinue use and contact Customer Support at 1-855-914-2935. Although the canister can hold up to 2000cc (mL), the urine should be emptied regularly from the collection canister before volume reaches 1800cc (mL). Failure to empty canister before urine overflow may cause damage to the PureWick™ Urine Collection System and is not covered under the warranty. It is important that the port connections be connected correctly for proper operation of the PureWick™ Urine Collection System. Use of this equipment next to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Portable radio frequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30cm) to any part of the PureWick™ Urine Collection System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Use only PureWick™ Urine Collection System accessories with this device. Incompatible parts or accessories can result in degraded performance and will void the warranty. Do not use accessories past expiration date indicated on package labeling. Use only the PureWick™ Urine Collection System A/C power cord with the device. Use of an alternate consumer style A/C power adapter or an extension cord may cause damage to device and electrical shock or injury and will void the warranty. Do not place PureWick™ Urine Collection System or its cord across walkways creating a tripping hazard. For PW200: The battery cells used in this device may present a fire or chemical hazard. To minimize the risk of damaging the battery inside the PureWick™ Urine Collection System, do not use the device outside the indicated operating temperature range of 41°F – 104°F (5°C – 40°C). The battery is not intended to be replaced; replacement could result in a hazard. To reduce the risk of electrical shock or injury, do not disassemble this unit. No modification of this equipment is allowed.
