QiVi Lite Male External Catheter

QiVi Lite Male External Urine Management Device Features

• Universal Fit Design: The pouch opening securely fits around the base of the penis and the suprapubic region, accommodating both retracted penis and abdominal pannus
• Adequate Microclimate: Breathable layer and targeted air vents maintain a dry microclimate, preventing IAD, MASD, and infections
• Proprietary one-way valve: Promotes continuous urine drainage, preventing backflow for increased patient comfort
• Enhances patient comfort: Pouch design keeps urinary output isolated and anatomy dry
• Novel Derma-friendly Adhesive: Contours to suprapubic region for secure adhesion. Silicone-based adhesive allows trauma-free removal, effective even with moderate hair follicles
• Advanced Pleated Pouch: Innovative pleated pouch design increases device volume and improves patient comfort

Parts Description

1. An adhesive patch is designed to secure the device to the patient’s anatomy
2. Dual chamber pouch to collect and prevent urine back-flow
3. A drainage tube that connects to an external collection bag where the urine output is diverted

QiVi Lite Male External Catheter User Manual

What to Buy with QiVi Lite Male External Catheter

• Dale Hold-n-Place Foley Catheter Holder
• Urocare Fitz All Fabric Leg Bag Straps With Buttons
• Bard Catheter Plug And Cap

Indications for Use

The QiVi Lite device is indicated for non-invasive urine management in semi and non-ambulatory male patients by diverting and collecting urine away from the patient’s body.

Directions for Use QiVi Lite

1. Preparation of Device

1. In addition to QiVi Lite, an external urine collection bag and the associated tube are required
2. Always wear gloves before handling the patient
3. Unpack the device and set up the station close to the patient

2. Preparation of the Patient

1. Position the patient in a supine position with their legs slightly spread apart
2. Position yourself such that the patient’s urogenital region is clearly visible and easily accessible
3. Perform supra-pubic care and assess skin integrity
4. It is advisable to trim pubic hair to improve product performance

3. Placement of Device

1. Hold the top layer of the device to create space within the pouch lumen
2. Hold the base of the penile shaft and push down against the abdominal wall to expose full-length
3. Carefully slide the penile shaft through the pouch orifice all the way until the orifice is flush at the base of the shaft
4. While holding the device in place, starting from the top, remove the first half of the adhesive liner and smoothly adhere the adhesive over the supra-pubic region
5. While removing the liner towards the bottom, adhere the adhesive around the scrotum such that a tight seal is formed between the skin and the adhesive
6. Repeat the process for the second half of the adhesive liner
7. Connect the device to the external collection bag
8. Ensure all connections are secure
9. The collection bag must be placed a level below the device to initiate gravity-assisted siphon erect
10. Return the patient to a natural position

4. Maintenance of Device

1. Perform skin assessment periodically as per institutional protocol. Ensure the tube is connected at all times while the device is in use
2. Assess the device periodically to ensure proper placement, particularly after turning or repositioning the patient
3. Ensure the collection bag is placed a level below the device for effective drainage through siphon erect
4. Replace the device every 12 to 24 hours or change the shift. Dispose of the device as per institutional protocol
5. Replace the tube and empty and/or replace the external collection bag as per institutional protocol

5. Removal of Device

1. Position the patient in a supine position with their legs slightly spread apart
2. Position yourself such that the patient’s urogenital region is clearly visible and easily accessible
3. Starting from one end, gently remove the adhesive patch
4. Carefully retract the penis from the pouch orifice and remove the device
5. Drain all fluid into the collection bag, disconnect the device, and discard as per institutional protocol
6. Perform supra-pubic care if required

Contraindications

DO NOT use on patients who:

• Have Urinary retention
• Have an allergy to adhesive or any other device material
• Have female anatomy
• Have glans and/or penile shaft complications, including but not limited to open lesions, skin irritations, ulcers, inflammation

Warnings

• Use QiVi Lite-Male External Urine Management device only with the designated energy source, avoiding compression or restricted fluid/air flow
• Prepare the skin before application and removal to prevent potential skin injury-handle with care
• Discontinue use immediately if any allergic reactions are noticed
• After use, treat it as a potential biohazard and dispose of it according to your institution's protocol

Precautions

• It is not recommended for agitated, restless, or uncooperative patients who may remove the device
• Avoid use in patients with skin irritation or breakdown at the application site
• Inappropriate for stool collection
• Use caution in patients who recently underwent surgery in the external urogenital area
• Assess skin integrity and perform supra-pubic care before product placement
• Handle adhesive carefully to prevent paper cuts from the liner
• Ensure secure connections between tubing, device, and collection bag to prevent leakage
• Keep the collection bag positioned below the device for gravity-assisted drainage