▪ Do not leave the system on for inappropriately long compressions, as tissue damage may be
produced. A brief interruption every three (3) hours of pressure is recommended during long
compression periods.
▪ Do not use RadiStop Compression Assist Device without the support plate. The support plate
ensures that the venous flow is not obstructed.
General Precautions
▪ Federal (USA) law restricts this device to sale by or on the order of a physician.
▪ Use of RadiStop Compression Assist Device is not intended to replace careful monitoring of
the patient's puncture site.
▪ The patient should not be left completely unattended during the time of compression.
Direction for Use
1.
Place the patient's (left or right) hand into the sterile support plate. The hand should be in
the same direction as the "hand" symbol on the support plate.
2.
Place the distal strap over the palm and distal to the thumb and tighten to a comfortable fit,
see figure 1. Wrap the proximal strap around the patient's forearm, see figure 2. Do not over
tighten the proximal strap as this may cause discomfort.
3.
Center the compression pad directly over the puncture site. Withdraw the introducer sheath
just enough to clear the rim of the compression pad, see figure 3.
CAUTION: To avoid vessel damage: Do not apply pressure to the compression pad until the
introducer sheath is completely removed.
4.
Confirm correct placement through the transparent pad. Positioning directly over the punc-
ture site will help to prevent bleeding from collateral blood supply. Thread the compression
pad strap through the loop on the compression pad rim.
5.
Remove the sheath with one hand and hold the compression pad with the other hand. Hold
the thumb firmly on the compression pad and the fingers securely around the support plate,
see figure 4.
NOTE: The compression pad shall be kept leveled to the skin surface.
6.
Continue to apply manual compression while securing the Velcro part of the compression
pad strap, see figure 5. Adjust the pressure by tightening or loosening the compression pad
strap.
CAUTION: The minimum pressure necessary to achieve hemostasis should be used.
Ideally residual radial pulse should be palpable while manually occluding the ulnar artery. If
complete occlusion of the artery is necessary to achieve hemostasis, the artery should not
be occluded for more than 10 - 15 minutes.
7.
When hemostasis is obtained, check the radial pulse distal to the compression pad.
CAUTION: Pressure should be adjusted until hemostasis and distal radial pulse are ob-
tained. Ideally residual radial pulse should be palpable while manually occluding the ulnar
artery. Excess part of the Velcro strap can be cut or fixed (thread under the compression
pad strap, see figure 6) to prevent the Velcro strap from attaching to other fabrics.
8.
Check hemostasis and patient tolerance.
9.
Maintain pressure for hemostasis for what would be considered the routine duration required
for the specific patient´s anticoagulant level, the interventional procedure performed and the
sheath French size used, e.g. a total of two (2) hours following a diagnostic procedure and
total of four (4) hours following an interventional procedure.
10. Once total hemostasis has been established, remove the device.
11. Dress the wound as per hospital routine. The support plate may be left in place with zero or
very low pressure in order to facilitate maintained hemostasis.
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