LeMaitre Omniflow II User manual

Omniow® II Vascular Prosthesis
Omniow® II Vascular Prosthesis
Patient Information – English

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Omniow® II Vascular Prosthesis
Patient Information – English
i. Omniow II - Straight Prosthesis
Length 5 mm Diameter 6 mm Diameter 7 mm Diameter 8 mm Diameter
20 cm 751-520 751-620 751-720 751-820
30 cm 751-530 751-630 751-730 751-830
40 cm 751-540 751-640 751-740 751-840
50 cm 751-550 751-650 751-750 751-850
60 cm 751-560 751-660 751-760 751-860
65 cm 751-565 751-665 751-765 751-865
ii. Omniow II - Curved Prosthesis
Length 6 mm Diameter
30 cm 741-630
35 cm 741-635
40 cm 741-640
45 cm 741-645
Intended Use
The Omniow IIVascular Prosthesis is used to replace diseased or damaged blood vessels or used as a conduit for hemodialysis.
Intended Purpose
• The Omniow IIVascular Prosthesis is an innovative graft that is composed of cross-linked ovine collagen and a polyester mesh endoskeleton. The graft
oers a solution for peripheral vessel reconstruction, bypassing or patching.
• When a vein is not available the graft oers a solution for vascular access for hemodialysis.
Intended Patient Population
The graft is designed for patients with variable ages, weights, diagnoses and heath statuses.
Self-Care Instructions
1. Your new device is a foreign body and therefore needs close monitoring and careful observation. It may take 6-8 weeks for full recovery.
2. After placement, the implant area may be swollen and tender for up to a week.
3. Observe for any new redness or tenderness.
4. Observe for any opening in the incisions.
5. Observe for numbness, tingling or pain in the leg, the new graft.
NOTE: If you experience 2-5 above please contact your provider.
6. Do not puncture or manipulate the graft.
7. You may shower according to your provider’s instructions.
8. Swelling in the extremity is expected because of increased blood ow. Move according to your provider’s instructions. If the graft was implanted in
your leg, frequently elevate leg above your heart.
9. It is preferable to have the surgical site covered for the rst week to protect skin and incisions. (Follow your provider’s instructions)
10. Keep bandages or compression bandages on as per your provider’s instructions.
11. If your staples have been removed, you will probably have Steri-Strips (small pieces of tape) across your incision. Wear loose clothing that does not
rub against your incision.
12. You may shower or get the incision wet, once your provider says you can. DO NOT soak, scrub, or have the shower beat directly on them. If you have
Steri-Strips, they will curl up and fall o on their own after a week.
13. DO NOT soak in the bathtub, a hot tub, or a swimming pool. Ask your provider when you can start doing these activities again.
14. Your provider will tell you how often to change your dressing (bandage) and when you may stop using one. Keep your wound dry. If your incision goes
to your groin, keep a dry gauze pad over it to keep it dry.
15. Clean your incision with soap and water every day once your provider says you can. Look carefully for any changes. Gently pat it dry.
16. DO NOT put any lotion, cream, or herbal remedy on your wound without rst discussing with your provider.
17. Bypass surgery does not cure the cause of the blockage in your arteries.Your arteries may become narrow again.
18. Eat a heart-healthy diet, exercise, stop smoking (if you smoke), and reduce stress. Doing these things will help lower your chances of developing a
blocked artery again.
19. Your provider may give you medicine to help lower your cholesterol.
20. If you are taking prescriptions for high blood pressure or diabetes, take them as prescribed.
21. Your provider may ask you to take aspirin or other over-the-counter or prescription medicine to prevent blood clots. DO NOT stop taking them without

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talking to your provider rst.
Intended Performance
• Patient monitoring is essential when the graft is used for vascular access to prevent excessive damage from complications.
• This is your graft and part of your body. If there is any evidence of bulge, redness, tenderness, or skin changes, immediately tell your provider.
Long-term Protection Measures for Your Graft
• Avoid prolonged extreme extension of the arm or leg with the implantation as it could lead to nerve damage.
• Avoid extreme or abrupt movements of the arm, shoulder, or legs during a post-operative period of 1.5 to 2 months. Specically, you should not reach out
in front, raise arms above shoulder level, throw, pull, stride, or twist.
• Avoid sleeping on the graft implantation side of your body or crossing your legs for prolonged periods as it may cause compression.
Electrical and Magnetic Sensitivity
• The device is not aected by electrical, magnetic or electro-magnetic interference. No precautions need to be taken when in the vicinity of these devices.
• There is no interaction of the graft with metal detectors and devices used at airport security checks.
Post-surgical Monitoring
• Check your incision and the rest of the implant extremity (arm or leg) every day. Pay attention to how you feel.
• Call your provider immediately if you have any signs of a blood clot, swelling, unusual skin color or infection such as:
1. Increased pain
2. Swelling, redness, or red streaks
3. Blood or pus draining from the incisions
4. Numbness
5. Fever
• Check for signs of good circulation. Your foot or leg should not be cool, pale, experience pain, change colors, have sudden bulging around the access site, or
have other symptoms similar to pre-surgery. Call your provider if you are experiencing any of these symptoms.
• Check for signs of good circulation. It is a problem if your hand or arm is cool or pale, if it changes color, or if you have sudden bulging around your access.
• Call your provider immediately if bleeding from your access site persists.
• The nature and frequency of regular or preventive examination, monitoring or maintenance will be determined by your provider. This will be based on
your underlying medical condition and the status of your graft.
Additional Post-surgical Monitoring for Hemodialysis
Check your access site for a pulse or“thrill”vibration. To feel it, place your rst two ngers over the graft, or listen with a stethoscope. If you are able to listen
with a stethoscope, you should be able to hear a repetitive whooshing sound. If you do not hear it or feel a pulse, the graft may be malfunctioning. Contact
your provider with any concerns.
Lifetime of the Device
• The lifetime of the device has been shown to be safe and eective up to 6.5 years on average. Proper care and regular medical follow up may extend the
life of the device.
• To ensure your graft functions as intended, follow the guidance of your health care provider.
When to Contact Your Provider
Closely watch for any changes in your health. Seek emergency care anytime you experience:
• Lost consciousness
• Trouble breathing
• Extremity has severe pain or becomes cold, pale, blue, tingly, or numb.
• Pain that does not get better after you take pain medicine.
• Loose stitches, or your incision opens.
• Extensive bleeding from the incision.
• Signs of infection, such as:
1. Increased pain, swelling, warmth, or redness.
2. Red streaks leading from the incision.
3. Pus draining from the incision.
4. A fever over 101°F (38.3°C).
5. You are nauseous or cannot keep uids down.
• You have chest pain, dizziness, problems thinking clearly, or shortness of breath that does not go away when you rest
• You are coughing up blood or yellow or green mucus
• You have chills

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• You experience abdominal pain or bloating
Device Materials
The following materials make up the Omniow II Prosthesis. All materials have passed biocompatibility testing to ensure they are safe to use:
• Ovine brocollagenous tissue reinforced with polyester mesh.
• Low levels of residual Glutaraldehyde.
In Case of an Emergency
Please make sure any serious incident that occurs in relation to the device you have is reported to the manufacturer and to the Therapeutic Goods
Administration (or other local Medical Device regulatory agency); at the address of theTherapeutic Goods Administration website
• Any serious adverse reaction should immediately be reported to your doctor. You may also report the incident to theTherapeutic Goods Administration
via their website (https://www.tga.gov.au/) and the manufacturer, LeMaitreVascular, Inc. ([phone] or; https://www.lemaitre.com/contact-us/
email-us).

R4197-01 Rev. A 02/22
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LeMaitre Vascular, Inc.
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Australian Sponsor
Emergo Australia
Level 20, Tower II, Darling Park
201 Sussex Street
Sydney, NSW 2000, Australia
AUS
LeMaitre and Omniow are registered trademarks of LeMaitre Vascular, Inc.
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