|
The reported event was inconclusive due to sample condition.Evaluation of the photo sample noted a bruise on the patient.However, it cannot be determine if the bruise was in relation to device function.Additionally, a photo of the device was received.However, device function cannot be assessed without receipt of the physical sample.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿welcome thank you for purchasing the drydoc¿ vacuum station, the vacuum suction to be used with the purewick¿ female external catheter (¿purewick¿ fec¿).Please read all operating instructions, safety information, and warnings before first use of this product.For more information, visit www.Liberatormedical.Com/purewick table of contents page specifications.3 safety information.4 drydoc¿ vacuum station unpack and setup.6 purewick¿ fec instructions for use.8 care and maintenance.10 troubleshooting.11 replacement and accessory items.13 customer support.14 warranty information.15 specifications ac input voltage: 100¿120vac operating environment ac frequency: 60hz temperature: 50°f¿95°f (10°c¿35°c) ac connector: nema 1-15p relative humidity: 5¿70%, non-condensing u.S.Patent no.8,287,508 safety information for drydoc¿ vacuum station ¿ always unplug drydoc¿ vacuum station when not in use.¿ do not immerse in water.As with most electrical devices, electrical parts in this system are electrically live even when the power is off.To reduce risk of electric shock, if the drydoc¿ vacuum station falls into water, unplug immediately.Do not reach into water.¿ if drydoc¿ vacuum station is dropped or tipped over spilling urine, unplug the unit and thoroughly inspect for loose or damaged parts before resuming use.Contact customer support at 1-888-201-1586 if damage is observed.¿ the 16¿ vacuum tubing connecting drydoc¿ vacuum station to collection canister may experience light condensation.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 1-888-201-1586.Some indications that water or urine has streamed into the pump are fluid or stains observed on the bottom exterior of device.¿ empty urine from collection canister regularly to prevent overflow.Failure to empty canister before urine overflow may cause damage to drydoc¿ vacuum station and is not covered under warranty.¿ it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station.¿ do not place drydoc¿ vacuum station or its cord across walkways creating a tripping hazard.To reduce the risk of electrical shock or injury, do not disassemble this unit.Warning: this product can expose you to di(2-ethylhexyl) phthalate (dehp), which is known to the state of california to cause cancer and birth defects or other reproductive harm.For more information, go to: https://www.P65warnings.Ca.Gov drydoc¿ vacuum station unpack and setup ¿ inspect the shipping box for damage.If damage is noticed, contact liberator medical at 1-888-201-1586 immediately.Carefully remove the unit and all contents, including the packing material, from the shipping container and inspect carefully prior to use.¿ place the drydoc¿ vacuum station (a) next to the bed or chair where it will be used.It must be close enough for the 70¿ patient tubing (b) to easily reach the user.* avoid creating a tripping hazard with the patient tubing or drydoc¿ vacuum station.*the drydoc¿ vacuum station should be placed on a stable and even surface at or below the user¿s level.¿ plug the drydoc¿ vacuum station power cord into an electrical outlet.¿ place the collection canister (c) in the drydoc¿ vacuum station base and press down firmly on the lid.Attach the 16¿ vacuum tubing (d) to the drydoc¿ vacuum station connector port (e) and the connector port labeled ¿vacuum¿ (f) on the collection canister lid.¿ attach the 70¿ patient tubing (b) to the connector port labeled ¿patient¿ (g) on the collection canister lid.Connect the other end of the 70¿ patient tubing securely to purewick¿ fec (h).Caution: it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station.¿ turn on the drydoc¿ vacuum station by pressing the on/off switch on top of the drydoc¿ vacuum station.The drydoc¿ vacuum station is functioning when the switch illuminates and the pump makes a soft humming sound.The system is now ready for use.Purewick¿ female external catheter (fec) instructions for use female external catheter tm setup: 1.Connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.If using the drydoctm vacuum station, connect the canister to the unit and turn the unit on.Please consult the drydoctm vacuum station user guide for further information.2.Using standard suction tubing, connect the purewicktm female external catheter to the collection canister.Peri-care and placement: 3.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.4.With soft gauze side facing patient, align distal end of the purewicktm female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewicktm female external catheter is positioned.Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Removal: 5.To remove the purewicktm female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewicktm female external catheter directly outward.Ensure suction is maintained while removing the purewicktm female external catheter.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Maintenance: 6.Replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.External use only purewick¿ female external catheter (fec) instructions for use (continued) indication for use: the purewick¿ female external catheter (fec) is intended for non-invasive urine output management for female patients.Caution: the purewick fec contains dry natural rubber contraindications (not to be used by): ¿ patients who retain urine, or are unable to empty their bladder.Warnings: ¿ do not use the purewick¿ fec with a bedpan or any material that does not allow for sufficient airflow.¿ to avoid potential skin injury, never push or pull the purewick¿ fec against the skin during placement or removal.¿ never insert the purewick¿ fec 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.Precautions: ¿ not recommended for patients who are: ¿ agitated, combative, or uncooperative and might remove the purewick¿ fec ¿ 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¿ fec.Barrier cream may impede suction.¿ not recommended for use on patients with a known latex allergy.¿ 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¿ fec.¿ maintain suction until the purewick¿ fec is fully removed from the patient to avoid urine backflow.Recommendations: ¿ in the home setting, wash hands thoroughly before device placement.¿ properly placing the purewick¿ fec snugly between the labia and gluteus holds the purewick¿ fec in place for most patients.Mesh underwear may be useful for securing the purewick¿ fec for some patients.¿ check device placement and the patient¿s skin at least every 2 hours.¿ replace the purewick¿ fec every 8-12 hours or when soiled with feces or blood.¿ change suction tubing at least every thirty (30) days.Care and maintenance of the drydoc¿ vacuum station inspect the drydoc¿ vacuum station periodically for wear.Do not attempt to open or dismantle the drydoc¿ vacuum station.This may affect performance, create a potential safety hazard, cause personal injury and will void the warranty.Replacing canister and tubing consider replacing the canister and/or tubing if you notice any of the following: ¿ canister or tubing have residual urine build-up ¿ canister or tubing appear cloudy ¿ canister or tubing appear discolored ¿ canister becomes cracked ¿ tubing becomes torn ¿ purewick¿ fec no longer securely connects to patient tubing to order replacement accessories, please contact customer support at 1-888-201-1586.Storage when the drydoc¿ vacuum station is not in use, unplug power cord from its outlet.Troubleshooting symptom check the following the drydoc¿ vacuum station on/off switch does not glow when turned on ¿ check that the power cord is plugged into a functioning outlet.The user¿s skin, clothing, bedding or diaper is slightly damp ¿ check the position of the purewick¿ fec.The user¿s skin, clothing, bedding or diaper is wet and/or the device is not suctioning properly ¿ check to ensure drydoc¿ vacuum station is turned on and plugged into a functioning outlet.When on, the on/ off switch glows and the system makes a humming sound.¿ be certain the overflow stop valve in center of underside of collection canister lid is open.This valve stops the vacuum by floating up to the closed position when the collection canister is full.It also closes when the lid or canister is tipped sideways or upside down.Disconnect vacuum tubing and gently shake the lid to reset the valve down to the open position.Troubleshooting symptom check the following the user¿s skin, clothing, bedding or diaper is wet and/or the device is not suctioning properly (continued) ¿ check tubing connections.Secure ends of vacuum tubing and confirm that (shorter) vacuum tubing is connected from vacuum port in center of collection canister lid to drydoc¿ vacuum station.Confirm that the patient tubing is firmly connected from purewick¿ fec to patient port near edge of collection canister lid.¿ check patient tubing for blockage or flow restriction such as pinched or kinked tubing ¿ check drydoc¿ vacuum station.With both tubes attached to collection canister lid, turn on drydoc¿ vacuum station.If a purewick¿ fec is attached to the end of the patient tubing, remove the purewick¿ fec and hold end of tubing in a cup of water.The system should easily vacuum water into collection canister.If not, check collection canister lid to be certain it is sealed.¿ if water easily flows into collection canister and the patient tubing is not blocked, replace current purewick¿ fec and carefully reposition purewick¿ fec as described on page 8 ¿purewick¿ female external catheter (fec) instructions for use.¿ ¿ make sure barrier creams aren¿t used while using the purewick¿ fec.Barrier creams may impede suction.There are no serviceable parts in the drydoc¿ vacuum station.Adjustments or modifications made will void the warranty (see page 15).".
|
