New Page 3

From: Subject: New Page 3 Date: Mon, 15 Jun 2009 10:52:50 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C9EDA7.6D3AEF30" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C9EDA7.6D3AEF30 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.grimedical.com/IARK%20Directions.htm New Page 3

3D"Directions
3DUp

SHIELS=20 INTUSSUSCEPTION

AIR = REDUCTION=20 SYSTEM

PRECAUTIONS=20

1. =20 Do not use this pneumatic insufflation device with = patients=20 who are in septic shock or have radiographic evidence of bowel=20 perforation.

2. =20 Colonic decompression should be performed by use of = the=20 stopcock handle only. = Do not=20 decompress the colon by turning the circular air release valve on = the=20 insufflator / gauge assembly.

3. =20 If using a pressure relief valve, forceful air = delivery may=20 cause the unit to exceed selected pressure level. Insufflate with = caution=20 when sustaining high pressures during pneumatic reduction.=20

4. =20 Always have an 18 gauge or larger needle immediately = available for peritoneal decompression in the event of bowel=20 perforation.

Caution: Federal law restricts = this device=20 to sale on or by the order of a physician. =

Directions for=20 Use

Shiels Intussusception Air = Reduction=20 System without pressure relief valve

1. =20 Prepare supplies which include air reduction tubing = set,=20 insufflator / gauge assembly, lubricant and tape. To avoid = accidental=20 damage to the pressure gauge, do not connect insufflator / gauge = assembly=20 until enema tip is secured in the rectum.

2. =20 Place enema tip into the rectum and securely tape = the=20 buttocks. The = stopcock handle=20 may be turned to the forward position to prevent reflux of stool = into the=20 tubing set. If = stool should=20 reflux into the tubing set, pump air forward to clear the = tubing. During normal use, stool = will not=20 permeate the filter, nor will it interfere with proper filter=20 function.

3. =20 Using the alignment dots and a clockwise turning = motion,=20 connect the insufflator / gauge assembly to the tubing set. Proper mounting will = place the=20 stopcock handle on the underside of the assembled pneumatic = reduction=20 system. DO NOT = over-tighten=20 the threaded mount, as this will result in suboptimal stopcock = handle=20 placement.

4. =20 Before beginning colonic insufflation, check to be = sure that=20 the stopcock handle is aligned with the sideport, thus insuring = forward=20 air flow for insufflation. = Check to insure that the black circular air release valve = is=20 completely closed and that the gauge is properly calibrated. The zero point for the = gauge=20 needle should be over the small rectangular box at the six o=92clock position on the gauge = dial.=20

5. =20 A quick system check for air leaks can be completed = by=20 folding the tubing closed while pumping a small amount of = air. If an air leak is = encountered,=20 recheck the stopcock handle and insufflator / gauge air release = valve for=20 proper and secure positioning.

6. =20 The underside placement of the stopcock handle = allows for=20 one =96handed operation and fingertip control for colonic=20 decompression. The = stopcock=20 handle is precisely positioned so that the device can be held and = operated=20 in either the right of left hand. During the enema, if the = monitored=20 pressure exceeds the operator=92s desired level, decompression is = instantly=20 accomplished by pulling the stopcock handle backward in a = trigger-like=20 fashion. The = airtight=20 stopcock, when pulled back, will close the gauge, registering the=20 intracolonic pressure at the time of decompression. =

7. =20 The device can be held at any level which = facilitates=20 simultaneous viewing of the pressure gauge and fluoroscopic = monitor.=20

8. =20 Upon completion of the air enema, if the radiologist = desires=20 to add positive contrast media the enema tip need not be = removed. To convert to a positive = contrast=20 enema, simply cut the clear tubing between the filter and enema = tip,=20 attach the =93Christmas tree=94 step connector (included in = package) and=20 connect the positive contrast tubing.

9. =20 Upon completion of the air enema, the entire tubing = system=20 should be discarded. = Do not=20 attempt to sterilize the tubing system for reuse. =

Directions for use=20 with Pressure Relief Valve

1. =20 Follow all instructions for Shiels intussusception = system=20 without relief valve.

2. =20 Attach the valve in between the stopcock and the = insufflater=20 / gauge device.

3. =20 During the enema, if the intracolonic pressure rises = to=20 120mm +/- 10%, the valve opens reducing the risk of unexpected = pressure=20 increase. A hissing = or=20 whistling sound can be heard when the device opens. =

4. =20 Remember: =20 Although this device is equipped with a pressure limiting = device=20 which opens approximately at 120 mmHg forceful air delivery may = cause the=20 unit to exceed this level. = Use caution when inflating the device and inflate = slowly.=20

5. =20 After enema is complete, remove the entire tubing = system=20 retaining the valve and insufflator / gauge. The tubing system is = for=20 single patient use only.

Note: This safety valve is = for releasing=20 the pressure during intussusception procedures. The valve is a=20 spring-loaded system incorporated in the t-connector before the=20 stopcock. The valve = is=20 calibrated to open at 2.5 atm (129mmHG), + / - 10%. This means the circuit = could open=20 anywhere in the range of 116 =96 142 mmHG. Before performing the = procedure=20 it is recommended that you test the valve by closing the stopcock = to the=20 circuit facing the inflator, and pumping the inflator until you = here a=20 hiss. Most = clinicians agree=20 that the maximum pressure for this procedure is 120mm HG when the = child is=20 at rest. Therefore, you must be = vigilant of=20 the pressure gauge as you pump air into this system. Failure to do so could = cause=20 perforation.

The valve can be reused if = desired,=20 since it is at the back end of the .22 micron filter on the = kit.=20

If you have any questions, do = not hesitate=20 to contact GRI at 800-291-9425 or email snider@grimedical.com = =

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http://www.grimedical.com/_themes/pstmdrn/pstm1101.css .mstheme { separator-image: url(poshorsd.gif); list-image-1: url(posbul1d.gif); = list-image-2: url(posbul2d.gif); list-image-3: url(posbul3d.gif); = nav-banner-image: url(posbannd.gif); navbutton-horiz-normal: = url(poshbudd.gif); navbutton-horiz-pushed: url(poshbusd.gif); = navbutton-vert-normal: url(posvbudd.gif); navbutton-vert-pushed: = url(posvbusd.gif); navbutton-home-normal: url(poshombd.gif); = navbutton-next-normal: url(posnexbd.gif); navbutton-prev-normal: = url(posprebd.gif); navbutton-up-normal: url(posupbd.gif) } .mstheme-bannertxt { VERTICAL-ALIGN: middle; COLOR: rgb(102,102,153); FONT-FAMILY: Arial, = Helvetica; TEXT-ALIGN: center } .mstheme-horiz-navtxt { FONT-WEIGHT: bold; VERTICAL-ALIGN: middle; COLOR: rgb(0,0,0); = FONT-FAMILY: Arial, Helvetica; TEXT-ALIGN: center } .mstheme-vert-navtxt { FONT-WEIGHT: bold; VERTICAL-ALIGN: middle; COLOR: rgb(0,0,0); = FONT-FAMILY: Arial, Helvetica; TEXT-ALIGN: center } .mstheme-navtxthome { VERTICAL-ALIGN: middle; COLOR: rgb(0,0,0); FONT-FAMILY: Arial, = Helvetica; TEXT-ALIGN: center } .mstheme-navtxtnext { VERTICAL-ALIGN: middle; COLOR: rgb(0,0,0); FONT-FAMILY: Arial, = Helvetica; TEXT-ALIGN: center } .mstheme-navtxtprev { VERTICAL-ALIGN: middle; COLOR: rgb(0,0,0); FONT-FAMILY: Arial, = Helvetica; TEXT-ALIGN: center } .mstheme-navtxtup { VERTICAL-ALIGN: middle; COLOR: rgb(0,0,0); FONT-FAMILY: Arial, = Helvetica; TEXT-ALIGN: center } UL { LIST-STYLE-IMAGE: url(posbul1d.gif) } UL UL { LIST-STYLE-IMAGE: url(posbul2d.gif) } UL UL UL { LIST-STYLE-IMAGE: url(posbul3d.gif) } A:link { COLOR: rgb(102,51,153) } A:visited { COLOR: rgb(153,51,51) } A:active { COLOR: rgb(255,153,51) } BODY { COLOR: rgb(0,0,153); BACKGROUND-COLOR: rgb(255,255,204) } H1 { COLOR: rgb(0,0,102) } H2 { COLOR: rgb(102,102,153) } MARQUEE { COLOR: rgb(102,102,153) } H3 { COLOR: rgb(102,102,51) } H4 { COLOR: rgb(0,0,102) } H5 { COLOR: rgb(102,102,153) } H6 { COLOR: rgb(102,102,51) } HR { COLOR: rgb(102,102,51) } BUTTON { BORDER-LEFT-COLOR: rgb(102,102,153); BORDER-BOTTOM-COLOR: = rgb(102,102,153); COLOR: white; BORDER-TOP-COLOR: rgb(102,102,153); = BACKGROUND-COLOR: rgb(0,0,102); BORDER-RIGHT-COLOR: rgb(102,102,153) } LABEL { COLOR: rgb(0,0,153) } .MSTHEME-LABEL { COLOR: rgb(0,0,153) } TEXTAREA { BORDER-LEFT-COLOR: rgb(0,0,102); BORDER-BOTTOM-COLOR: rgb(0,0,102); = COLOR: black; BORDER-TOP-COLOR: rgb(0,0,102); BORDER-RIGHT-COLOR: = rgb(0,0,102) } FIELDSET { BORDER-LEFT-COLOR: rgb(0,0,102); BORDER-BOTTOM-COLOR: rgb(0,0,102); = COLOR: black; BORDER-TOP-COLOR: rgb(0,0,102); BORDER-RIGHT-COLOR: = rgb(0,0,102) } LEGEND { COLOR: rgb(102,102,51) } SELECT { BORDER-LEFT-COLOR: rgb(0,0,102); BORDER-BOTTOM-COLOR: rgb(0,0,102); = COLOR: black; BORDER-TOP-COLOR: rgb(0,0,102); BORDER-RIGHT-COLOR: = rgb(0,0,102) } TABLE { BORDER-LEFT-COLOR: rgb(0,0,102); BORDER-BOTTOM-COLOR: rgb(0,0,102); = COLOR: rgb(0,0,153); BORDER-TOP-COLOR: rgb(0,0,102); BORDER-RIGHT-COLOR: = rgb(0,0,102); table-border-color-light: rgb(102,102,153); = table-border-color-dark: rgb(0,0,102) } CAPTION { COLOR: rgb(102,102,51) } TH { BORDER-LEFT-COLOR: rgb(0,0,102); BORDER-BOTTOM-COLOR: rgb(0,0,102); = COLOR: rgb(0,0,153); BORDER-TOP-COLOR: rgb(0,0,102); BORDER-RIGHT-COLOR: = rgb(0,0,102) } TD { BORDER-LEFT-COLOR: rgb(0,0,102); BORDER-BOTTOM-COLOR: rgb(0,0,102); = BORDER-TOP-COLOR: rgb(0,0,102); BORDER-RIGHT-COLOR: rgb(0,0,102) } .mstheme-bannertxt A:active { COLOR: rgb(102,102,153) } .mstheme-bannertxt A:link { COLOR: rgb(102,102,153) } .mstheme-bannertxt A:visited { COLOR: rgb(102,102,153) } .mstheme-bannertxt-g { BACKGROUND-IMAGE: url(posbannd.gif); VERTICAL-ALIGN: middle; COLOR: = rgb(102,102,153); FONT-FAMILY: Arial, Helvetica; TEXT-ALIGN: center } .mstheme-bannertxt-g A:active { COLOR: rgb(102,102,153) } .mstheme-bannertxt-g A:link { COLOR: rgb(102,102,153) } .mstheme-bannertxt-g A:visited { COLOR: rgb(102,102,153) } .mstheme-bannertxt-s { VERTICAL-ALIGN: middle; COLOR: 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.mstheme-navtxtprev A:active { COLOR: rgb(0,0,0) } .mstheme-navtxtprev A:link { COLOR: rgb(0,0,0) } .mstheme-navtxtprev A:visited { COLOR: rgb(0,0,0) } .mstheme-navtxtprev-g { BACKGROUND-IMAGE: url(posprebd.gif); VERTICAL-ALIGN: middle; COLOR: = rgb(0,0,0); FONT-FAMILY: Arial, Helvetica; TEXT-ALIGN: center } .mstheme-navtxtprev-g A:active { COLOR: rgb(0,0,0) } .mstheme-navtxtprev-g A:link { COLOR: rgb(0,0,0) } .mstheme-navtxtprev-g A:visited { COLOR: rgb(0,0,0) } .mstheme-navtxtup A:active { COLOR: rgb(0,0,0) } .mstheme-navtxtup A:link { COLOR: rgb(0,0,0) } .mstheme-navtxtup A:visited { COLOR: rgb(0,0,0) } .mstheme-navtxtup-g { BACKGROUND-IMAGE: url(posupbd.gif); VERTICAL-ALIGN: middle; COLOR: = rgb(0,0,0); FONT-FAMILY: Arial, Helvetica; TEXT-ALIGN: center } .mstheme-navtxtup-g A:active { COLOR: rgb(0,0,0) } .mstheme-navtxtup-g A:link { COLOR: rgb(0,0,0) } .mstheme-navtxtup-g A:visited { COLOR: rgb(0,0,0) } .mstheme-topbar-font A:active { COLOR: rgb(0,0,0) } .mstheme-topbar-font A:link { COLOR: rgb(0,0,0) } .mstheme-topbar-font A:visited { COLOR: rgb(0,0,0) } .mstheme-topbar-font-g { FONT-SIZE: 1px; BACKGROUND-IMAGE: url(posglob.gif); COLOR: rgb(0,0,0); = FONT-FAMILY: Arial, Helvetica } .mstheme-topbar-font-g A:active { COLOR: rgb(0,0,0) } .mstheme-topbar-font-g A:link { COLOR: rgb(0,0,0) } .mstheme-topbar-font-g A:visited { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt A:active { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt A:link { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt A:visited { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt-g { BACKGROUND-IMAGE: url(posvbudd.gif); VERTICAL-ALIGN: middle; COLOR: = rgb(0,0,0); FONT-FAMILY: Arial, Helvetica; TEXT-ALIGN: center } .mstheme-vert-navtxt-g A:active { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt-g A:link { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt-g A:visited { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt-gs { BACKGROUND-IMAGE: url(posvbusd.gif); VERTICAL-ALIGN: middle; COLOR: = rgb(0,0,0); FONT-FAMILY: Arial, Helvetica; TEXT-ALIGN: center } .mstheme-vert-navtxt-gs A:active { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt-gs A:link { COLOR: rgb(0,0,0) } .mstheme-vert-navtxt-gs A:visited { COLOR: rgb(0,0,0) } .mstheme { navbutton-background-color: rgb(255,255,204); top-bar-button: = url(posglob.gif) } .mstheme-topbar-font { FONT-SIZE: 1px; COLOR: rgb(0,0,0); FONT-FAMILY: Arial, Helvetica } BODY { BACKGROUND-IMAGE: url(postextb.gif); FONT-FAMILY: Arial, Helvetica } H1 { FONT-WEIGHT: normal; FONT-SIZE: 24pt; FONT-STYLE: normal; FONT-FAMILY: = Arial, Helvetica } H2 { FONT-WEIGHT: normal; FONT-SIZE: 18pt; FONT-STYLE: normal; FONT-FAMILY: = Arial, Helvetica } H3 { FONT-WEIGHT: normal; FONT-SIZE: 14pt; FONT-STYLE: normal; FONT-FAMILY: = Arial, Helvetica } H4 { FONT-WEIGHT: normal; FONT-SIZE: 12pt; FONT-STYLE: normal; FONT-FAMILY: = Arial, Helvetica } H5 { FONT-WEIGHT: normal; FONT-SIZE: 10pt; FONT-STYLE: normal; FONT-FAMILY: = Arial, Helvetica } H6 { FONT-WEIGHT: normal; FONT-SIZE: 8pt; FONT-STYLE: normal; FONT-FAMILY: = Arial, Helvetica } BUTTON { BORDER-RIGHT: 1pt solid; BORDER-TOP: 1pt solid; FONT-SIZE: 8pt; = BORDER-LEFT: 1pt solid; BORDER-BOTTOM: 1pt solid; FONT-STYLE: normal; = FONT-FAMILY: Arial, Helvetica } LABEL { FONT-SIZE: 8pt; FONT-STYLE: normal; FONT-FAMILY: Arial, Helvetica } .MSTHEME-LABEL { FONT-SIZE: 8pt; FONT-STYLE: normal; FONT-FAMILY: Arial, Helvetica } TEXTAREA { FONT-SIZE: 8pt; BORDER-TOP-STYLE: solid; FONT-STYLE: normal; = FONT-FAMILY: Arial, Helvetica; BORDER-RIGHT-STYLE: solid; = BORDER-LEFT-STYLE: solid; BORDER-BOTTOM-STYLE: solid } FIELDSET { BORDER-RIGHT: 1pt solid; BORDER-TOP: 1pt solid; FONT-SIZE: 8pt; = BORDER-LEFT: 1pt solid; BORDER-BOTTOM: 1pt solid; FONT-STYLE: normal; = FONT-FAMILY: Arial, Helvetica } LEGEND { FONT-SIZE: 8pt; FONT-STYLE: normal; FONT-FAMILY: Arial, Helvetica } SELECT { FONT-SIZE: 8pt; BORDER-TOP-STYLE: solid; FONT-STYLE: normal; = FONT-FAMILY: Arial, Helvetica; BORDER-RIGHT-STYLE: solid; = BORDER-LEFT-STYLE: solid; BORDER-BOTTOM-STYLE: solid } TABLE { FONT-STYLE: normal; FONT-FAMILY: Arial, Helvetica } CAPTION { FONT-SIZE: 14pt; FONT-STYLE: normal; FONT-FAMILY: Arial, Helvetica } TH { FONT-STYLE: normal; FONT-FAMILY: Arial, Helvetica } MARQUEE { FONT-SIZE: 14pt; FONT-FAMILY: Arial, Helvetica } ------=_NextPart_000_0000_01C9EDA7.6D3AEF30--