HALO360+Procedure Worksheet for Barrett`s

HALO360+ Procedure Worksheet for Barrett’s Esophagus
NOTE: This guide is not meant to replace physician judgment. Consult Instructions For Use ( IFU )
for complete representation of procedural steps, contraindications, warnings, and precautions.
guidewire
Sticker
Sizing Balloon
Sticker
ablation catheter
Sticker
Energy Density Setting
10J/cm2 for Non-Dysplasia
12J/cm2 for Dysplasia
Total Number of Ablations
First Pass
Second Pass
Procedure Quick Steps (check off items as completed )
P erform endoscopy to identify landmarks – TIM and TGF
Irrigate with N-acetylcysteine (Mucomyst†) (1% in plain water) –
Do not use saline
Record TGF and TIM
Place guidewire
Remove endoscope leaving guidewire in place
Calibrate sizing balloon in plastic sleeve, outside patient
Advance sizing balloon over guidewire
Begin sizing 12cm above the recorded TGF*
Size every 1cm, advancing distally, until an abruptly larger diameter
is indicated
Disconnect and remove sizing balloon keeping guidewire in place
Pass recommended ablation catheter over guidewire
Lightly lube and introduce endoscope for direct visualization
Align the proximal edge of the electrode 1cm above the TIM
Inflate/ablate one time, move distally 3cm, repeat until distal end
of treatment zone overlaps TGF
Withdraw endoscope, ablation catheter and guidewire
together as a unit
Place HALO Cap on endoscope and remove coagulated tissue
Clean catheter outside patient
Repeat ablation process
* If treating more proximally than 12cm above the TGF, beginning measurements
more proximally may be advisable
/
Patient Information:
Distance
from
Biteblock
Balloon
Diameter
Auto-Sizing
Estimate
Location of Each
Recommended Ablation Zone
(3cm vertical
Ablation
length per zone)
Catheter
20cm
mm
mm
21cm
mm
mm
22cm
mm
mm
23cm
mm
mm
24cm
mm
mm
25cm
mm
mm
26cm
mm
mm
27cm
mm
mm
28cm
mm
mm
29cm
mm
mm
30cm
mm
mm
31cm
mm
mm
32cm
mm
mm
33cm
mm
mm
34cm
mm
mm
35cm
mm
mm
36cm
mm
mm
37cm
mm
mm
38cm
mm
mm
39cm
mm
mm
40cm
mm
mm
41cm
mm
mm
42cm
mm
mm
43cm
mm
mm
† Mucomyst diluted to 1% (10% Mucomyst solution = 6 cc of Mucomyst and
44cm
mm
mm
Notes
45cm
mm
mm
54 cc of water, 20% Mucomyst = 3 cc of Mucomyst and 57 cc of water)
/
HALO Cap
Sticker
Identify Landmarks
J Circle and label Top of Gastric Folds (TGF) – TGF measurement
JCircle and label Top of Intestinal Metaplasia (TIM)
(a.k.a. Top of Barrett’s) – TIM measurement
JCircle and label Sizing Start – subtract 12 from the TGF measurement
to determine Sizing Start
Example: TGF –12cm = Sizing Start*
Date:
1
2
3
4
(for pathology, type of catheter used, Prague classification, next appointment, etc.)
For questions regarding this form, contact your local BÂRRX Medical
Representative or call BÂRRX Medical Customer Service at 888-662-2779.
L-0001-01 Rev. E
(ECO #12297, 03/22/2012)
HALO360+ Procedure
RFA Procedure
Worksheet
Worksheet
for Barrett’s Esophagus
Note: For example ONLY – not actual measurements!
Distance
from
Biteblock
Balloon
Diameter
Auto-Sizing
Estimate
Location of Each
Recommended Ablation Zone
(3cm vertical
Ablation
length per zone)
Catheter
20cm
mm
mm
21cm
mm
mm
22cm
mm
mm
23cm
mm
mm
Step 3 •
24cm
mm
mm
Circle location
of Sizing Start
as calculated
12cm above
the TGF and
write “Start”
to the right.
25cm
mm
mm
26cm
mm
mm
Step 2 •
Circle location
of TIM and
write “TIM” next
to measurement
on right as called
out by physician.
27cm
28cm Start
Circle location
of Top of Gastric
Folds (TGF) and
write “TGF” next to
measurement on
right as called out
by physician.
mm
mm
•
22.7 mm
•
22 mm
30cm
22.2 mm
22 mm
32cm
33cm
37.2 mm
34cm
mm
mm
mm
mm
36cm TIM
mm
mm
37cm
mm
mm
38cm
mm
mm
mm
mm
mm
mm
41cm
mm
mm
42cm
mm
mm
43cm
mm
mm
39cm
40cm
•
•
TGF
3
• Step 5
After recording all
sizing and catheter
measurements,
circle the smallest
auto-sizing
measurement
and smallest
recommended
ablation catheter.
mm
44cm
mm
mm
45cm
mm
mm
4
• Step 4
Record auto-sizing
estimate AND the
corresponding
recommended
ablation catheter
side by side in
each column.
22 mm
•
22 mm
22.1 mm
•
22.3 mm
31cm
2
22 mm
22.8 mm
29cm
35cm
Step 1 •
•
1
• Step 6
Mark length of
ablation zone.
•
•
Step 7
Check off the
procedure steps
as completed,
on front page.
Notes
For questions regarding this form, contact your local BÂRRX Medical
Representative or call BÂRRX Medical Customer Service at 888-662-2779.
L-0001-01 Rev. E
(ECO #12297, 03/22/2012)

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