Merit Medical Safeguard 24cm IFU User Manual

24cm PRESSURE ASSISTED DEVICE
INSTRUCTIONS FOR USE
Read instructions prior to use. Product not made with natural rubber latex.
DEVICE DESCRIPTION
The SAFEGUARD 24cm is a single use disposable device. SAFEGUARD has a clear medical grade polyurethane window and bladder, a clear medical grade PVC exible ll tube, and a pressure sensitive, self­adhesive peel backing. A luer valve on the end of the ll tube enables a syringe to be connected to inate the central bladder with air to provide pressure to the puncture site. The SAFEGUARD pressure assisted device has a sterile dressing with a clear window that facilitates visibility of the access site without removal or manipulation of the device.
INDICATIONS
The indications for use for the SAFEGUARD 24cm pressure assisted device are to assist in obtaining and maintaining hemostasis. The device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interven tional procedures with an ACT of 140 seconds or less, using a 6 Fr. and smaller sheath size.
CONTRAINDICATIONS
The adhesive portion of the SAFEGUARD device should not be used over excoriated skin.
CAUTIONS Px Only. Caution: Federal (U.S.A.) law restricts this device to sale by or
on the order of a physician. CAUTION: With over-ination i.e., above 40mL’s of air, the bulb may begin to expand radially and could compromise the adhesive properties of the device. CAUTION: Under-ination of device could compromise the ability of the device to assist in obtaining and maintaining hemostasis.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
PRECAUTIONS
• Use proper aseptic techniques while handling product.
• Do not use if package is damaged
• Inspect device prior to use to verify that no damage has occurred during shipping.
POTENTIAL ADVERSE EFFECTS
Possible adverse eects that may result from the use of this device:
• Hematoma
• Local bleeding
• Arterio-venous stula or pseudoaneurysm
SAFETY AND EFFECTIVENESS RESULTS
A clinical trial was conducted to evaluate the safety and eectiveness of the SAFEGUARD Manual Assist Technique (MAT) in reducing active compression time compared to historical manual compression data. (Reduced Vascular Complications After Percutaneous Coronary Interventions with a Non-mechanical Suture Device: Results from the Randomized RACE Study, Sanborn, TA)
SAFEGUARD MAT Manual Compression N=100 Historical Control N=85
Avg. AC/TTH Manual 7.7 ± 3.3 28 Compression (minutes)
Manual Compression SAFEGUARD Historical MAT N=101 Control N=85
Major Complications
Access site bleeding requiring transfusion
Vascular repair or the need for vascular repair (via surgery, ultrasound-guided intervention, transcatheter embolization, or stent-graft)
Any new ipsilateral lower extremity ischemia
­Surgery for access site related nerve injury
Access site-related infection requiring IV antibiotics or extending hospitalization
Diagnostic
Interventional
0 0 0 0
0 1 0 2
0 0 0 0
0 0 0 0
0 0 0 0
Minor Complications * *
Access site hematoma >6 cm (after sheath pull)
Bleeding requiring > 30 minutes to
re-establish hemostasis
Non-treated pseudoaneurysm
Non-treated arteriovenous (AV) stula documented by ultrasound
Skin excoreation at site of Safeguard after removal of dressing
Skin erythema
Allergic reaction to adhesive
Ipsilateral lower extremity arterial emboli, transient loss of lower extremity pulse, or deep vein thrombosis
Access site-related vessel laceration
Transient access-site related nerve injury
Access site wound dehiscence
Localized access site infection treated with intramuscular or oral antibiotics
*None Reported
There is no statistical dierence in the rate of major complications between the control group and the treated group.
1 1 - -
0 0 - ­0 0 - -
0 0 - -
0 0 - -
0 0 - -
0 0 - ­0 0 - -
0 0 - -
0 0 - -
0 0 - ­0 0 - -
0 0 - -
PRE-HEMOSTASIS, or MANUAL ASSIST TECHNIQUE (MAT)
PLACEMENT OF SAFEGUARD
1. Before adhering SAFEGUARD to the patient, be sure skin is clean and dry. Determine the appropriate angle for SAFEGUARD placement to provide easy access to luer inate/deate port and to allow for easy sheath removal.
Note: Placement may require adjustment based on the patient’s anatomy, angle of the puncture site, and the presence or absence of a procedural sheath.
Diagnostic
Interventional
2. Consider the point of maximum pulse, anatomy, angle of puncture and direction of ow to determine the appropriate SAFEGUARD position and verify.
3. Pull the procedural sheath back approximately 1” (2.5cm) so that when SAFEGUARD is adhered to the skin the sheath hub is outside the area of the SAFEGUARD adhesive.
Note: It is recommended that you aspirate the sheath prior to removal to prevent distal embolization from residual clot in sheath.
4. Remove the adhesive backing and place the bulb where you would position your ngers to hold manual compression (for example, in femoral artery procedures, typically the point of maximum femoral pulse). Make sure SAFEGUARD is com pletely adhered to the skin.
5. Attach and completely engage a standard luer lock syringe to inate the desired volume a maximum volume of 40mL’s of air into the bulb to apply pressure on the arteriotomy site. Syringe must be completely engaged in the luer to inate/deate the bulb. Remove syringe.
Note: Maintain pressure on the plunger while detaching syringe from the SAFE GUARD valve. Observe that the desired pressure is achieved and maintained.
6. Remove sheath, then immediately apply manual compression directly over inated bulb.
7. Hold manual compression until hemo stasis has been achieved.*
• Slowly release manual compression.
• Check distal/proximal pulses to assure ow is maintained.
• Conrm hemostasis by viewing the site through the inated bulb window.
* Recommendations (MAT only): Diagnostic patients - minimum 5 minutes Interventional patients - minimum 10 minutes
8. Per hospital protocol, periodically check the site through the bulb window to conrm hemostasis and to manage the bulb volume and resultant pressure as needed. Continue to check distal/ proximal blood ow to assure patency.
9. Deate bulb every two hours to allow for capillary rell and to assess the site. Re-inate the bulb if necessary.
10. Deate the bulb by attaching an appropriately sized luer lock sy ringe to the valve, engage the valve and slowly depress the bulb allowing the syringe to ll with air. Alternatively, remove plunger from the syringe, attach syringe and allow air to slowly release while gently depressing the bulb.
Note: Do not draw negative pressure in the syringe, as this will create a vacuum on the site.
11. Prior to discharge of the patient, remove SAFEGUARD and apply sterile dressing per hospital protocol.
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POST-HEMOSTASIS TECHNIQUE
1. When hemostasis at the access site has been achieved, apply the SAFEGUARD device with the access site visible under the bulb window of the SAFEGUARD device. Consider the point of maximum pulse, anatomy, angle of puncture and direction of ow to determine the appropriate SAFEGUARD position and verify.
Note: Before adhering SAFEGUARD to the patient, be sure skin is clean and dry. Deter mine the appropriate angle for SAFEGUARD placement to provide easy access to luer inate/deate port.
2. Attach an appropriately sized standard luer lock syringe to the valve of the SAFEGUARD device.
Note: Syringe must be completely engaged
in the luer to inate/deate the bulb.
3. Inate the bulb of the SAFEGUARD device with air to the desired volume of air (24cm maximum of 40mL’s) to apply pressure on the arteriotomy site and re move the syringe. Check distal/proximal pulses to assure ow is maintained.
Note: Maintain pressure on the plunger while detaching syringe from the valve of the SAFEGUARD device. Observe that the desired volume is achieved and maintained.
4. Per hospital protocol, periodically check the site through the bulb window to assure hemostasis is maintained and the bulb maintains pressure.
5. Deate bulb every two hours and assess the site. Re-inate the bulb if necessary.
6. Deate the bulb by attaching an appropriately sized luer lock syringe to the valve, engage the valve and slowly depress the bulb allowing the syringe to ll with air. Alternatively, remove plunger from the syringe, attach syringe and allow air to slowly release while gently depressing the bulb.
Note: Do not draw negative pressure in the syringe, as this will create a vacuum on the site.
7. Prior to discharge of the patient, remove the SAFEGUARD device and apply sterile dressing per hospital protocol.
Maintain sterile eld during application.
Keep away from sunlight
Do not Resterilize
Do not Reuse
Do not use if package is damaged
Catalog Number
Lot Number
Use By
Sterilized Using Gamma
Caution: Consult accompanying document
Manufacturer
Authorized Representative
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Manufacturer: Merit Medical Systems, Inc. 1600 West Merit Parkway, South Jordan, Utah 84095 U.S.A. 1-801-253-1600 U.S.A. Customer Service 1-800-356-3748
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www.merit.com ID 010814 400373001/A