Boston Scientific EXALT D Manual

EXALT Model D
™
F O R U S E W I T H T H E E X A L T C O N T R O L L E R
Single-Use Duodenoscope
M00542420, M00542421
TABLE OF CONTENTS
REUSE WARNING ................................................................... 1
DEVICE DESCRIPTION ............................................................ 1
Contents ............................................................................ 1
Operating Principle ........................................................... 1
Features and Controls ........................................................2
Figure 1. .....................................................................................2
Figures 2 and 3. Main features of the Endoscope ......................3
Figure 4. .....................................................................................4
Figure 5. .....................................................................................5
Articulation Section ...........................................................5
Materials ............................................................................5
User Information................................................................5
Model Numbers .................................................................5
Specifications .....................................................................6
Table 1. Endoscope specifications ......................................6
INTENDED USE/INDICATIONS FOR USE ................................6
Clinical Benefit Statement .................................................6
CONTRAINDICATIONS ............................................................6
WARNINGS .............................................................................6
PRECAUTIONS ....................................................................... 8
ADVERSE EVENTS ................................................................10
CONFORMANCE TO STANDARDS ........................................10
Essential Performance Statement ...................................10
HOW SUPPLIED ....................................................................10
Device Details ..................................................................10
Handling and Storage ......................................................10
DEVICE COMPATIBILITY .......................................................10
OPERATIONAL INSTRUCTIONS ............................................10
Unpack and Inspect the Endoscope.................................10
Attaching the suction and air/water valves ......................11
Attaching the biopsy valves .............................................11
Connect the Endoscope to the Controller and
check the Image ...............................................................11
Figure 6. Inserting the umbilicus connector into the
Controller receptacle ................................................................ 12
Attach Suction and Air/Water Tubing .............................. 12
Test Suction and Air/Water Valves................................... 12
Test Working Channel and Elevator Function .................. 12
Preparation and Insertion of the Endoscope ................... 12
Inserting an Endoscopic Accessory Device into the
Single-Use Endoscope ..................................................... 13
Locking the guidewire ..................................................... 13
Removing an Accessory Device from the Endoscope ...... 13
Removing the Endoscope from the Patient ..................... 13
Disposal ........................................................................... 14
Post-Procedure ................................................................ 14
PATIENT COUNSELING INFORMATION ................................ 14
WARRANTY .......................................................................... 14
SYMBOL DEFINITIONS ......................................................... 14
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order
of a physician.
REUSE WARNING
For single 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.
DEVICE DESCRIPTION
Contents
The package includes:
One (1) EXALT Model D Single-Use Duodenoscope.
Ensure the package contains the components listed below.
Operating Principle
The EXALT Model D Single-Use Duodenoscope (hereafter referred to as
the Endoscope) is a sterile, single-use Endoscope that facilitates access to
the duodenum, delivery of accessories, and live video when connected to
an EXALT Controller (hereafter referred to as the Controller).
Black (K) ∆E ≤5.0