Given Imaging Bravo Bedienungsanleitung

Bravo® pH Monitoring System

User Guide

DOC-2033-07

Mar h 2016

logo and Further, Together are trademarks of Medtroni .

TM*

Third party brands are

trademarks of their respe tive owners. All other brands are trademarks of a Medtroni

ompany.

FCC Compliance Statement

This devi e omplies with Part 15 of the FCC. Operation is subje t to the following two

onditions:

1 This devi e may not ause harmful interferen e.

2 This devi e must a ept any interferen e re eived, in luding interferen e that

may ause undesired operation.

Given Imaging

15 Hampshire Street,

Mansfield, MA 02048 USA

[email protected]

Medtronic B.V.

Earl Bakkenstraat 10,

6422 PJ Heerlen, The Netherlands

Rx Only

Table of Contents

Bravo pH Monitoring System i User Guide

Bravo pH MS UGTOC.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

Table of Contents

Introduction......................................................................................................... 1

Description ............................................................................................. 1

Indications for Use ................................................................................. 1

Contraindications ................................................................................... 1

Warnings and Precautions ...................................................................... 2

Storage ................................................................................................... 3

Electromagnetic Compatibility .............................................................. 3

Patient Information Benefits and Risks) ............................................... 4

System Components ............................................................................... 5

System Workflow .................................................................................. 6

Bravo pH Recorder ............................................................................................. 7

Description ............................................................................................ 7

Backlight ................................................................................................ 7

Patient Buttons ....................................................................................... 7

Clinician Buttons and Menus ................................................................. 8

Status LED ............................................................................................. 9

General Guidelines ................................................................................. 9

Charging the Recorder ......................................................................... 10

Turning the Recorder On and Off ........................................................ 10

Setting the Date and Time .................................................................... 11

Choosing Study Settings ...................................................................... 11

Calibrating Capsules ......................................................................................... 13

Existing Data ........................................................................................ 13

Starting Calibration .............................................................................. 13

Performing a Bravo pH Study .......................................................................... 19

Setting up the Vacuum ......................................................................... 19

Starting Recording ............................................................................... 20

Placing the Capsule .............................................................................. 21

Stopping a pH Study ............................................................................ 25

Reviewing Instructions with Patients ................................................... 26

Uploading pH Data ........................................................................................... 28

Recorder Maintenance ...................................................................................... 29

Safety and Technical Checks ............................................................... 29

Cleaning the Recorder .......................................................................... 29

Cleaning the Case and Strap ................................................................ 29

Servicing the Battery ............................................................................ 29

Table of Contents

Bravo pH Monitoring System ii User Guide

Bravo pH MS UGTOC.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

Troubleshooting ................................................................................................ 30

Delivery Device Disassembly Procedure ............................................. 30

Recorder Troubleshooting .................................................................... 32

Appendix A: Technical Data ............................................................................ 35

Bravo pH Recorder .............................................................................. 35

Recorder Servicing ............................................................................... 35

USB Cable ........................................................................................... 36

Charger ................................................................................................ 36

Battery ................................................................................................. 36

FCC Compliance Statement ................................................................. 36

Declaration of Conformity ................................................................... 36

Essential Performance of Bravo Recorder ........................................... 36

Electromagnetic Compatibility Declaration EN / IEC 60601-1-2) .... 37

Bravo pH Capsule Specifications ........................................................ 41

Bravo pH Delivery Device Specifications ........................................... 41

Appendix B: Symbols on Package Labeling .................................................... 42

Bravo pH Monitoring System 1 User Guide

hapter.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

Introduction

Description

The Bravo

pH Monitoring System is intended to be used for gastroesophageal

pH measurement and monitoring of gastric reflux:

•

First, a Bravo pH capsule is calibrated and the Bravo pH recorder an ambulatory,

programmable data recorder) is prepared.

•

Using the delivery device, the capsule is positioned and attached in the patient’s

esophagus, following either endoscopy or manometry.

•

The data is collected by the capsule and transmitted to the recorder for the duration

of the study.

•

The data is then uploaded from the recorder to the software application on the PC or

workstation. The software application is used to record, store, view, and analyze

gastroesophageal pH data, enabling physicians to interpret study results.

Indications for Use

The Bravo pH Monitoring System is intended to be used for gastroesophageal pH

measurement and monitoring of gastric reflux in adults and children from 4 years of age.

The Bravo pH capsule can be attached following either endoscopy or manometry. The

AccuView and Reflux software applications are intended to record, store, view, and

analyze gastroesophageal pH data.

Contraindications

Patients with bleeding diathesis, strictures, severe esophagitis, varices, obstructions,

pacemakers or implantable cardiac defibrillators are contraindicated.

Warning

Patients are restri ted from undergoing an MRI study for 30 days from

the start of a pH study. The Bravo pH Monitoring System is not

ompatible for use in an MRI magneti field. Use of the Bravo pH

Monitoring System in an MRI magneti field will result in damage to the

system and possible patient injury.

Bravo pH Monitoring System 2 User Guide

hapter.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

Warnings and recautions

•

Bravo pH capsule with delivery device: Potential complications include, but are

not limited to:

• aspiration of the capsule if inadvertently pulled back up into the upper

esophagus by the delivery device. There is a possibility that this may occur in a

procedure in which the capsule did not attach to the esophageal mucosa.

• tears or perforations in the mucosal and submucosal layers of the esophagus

causing bleeding and requiring possible medical intervention.

•gastrointestinal endoscopy: Potential complications include, but are not

limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension,

respiratory arrest, and cardiac arrhythmia or arrest.

•nasal intubation: Potential complications include, but are not limited to: sore

throat, discomfort, and nasopharyngeal damage resulting in bleeding and soft

tissue damage.

•

Bravo pH capsule: Potential complications include, but are not limited to:

• discomfort associated with the capsule, or failure to detach from the esophagus

within several days after placement, either of which may necessitate endoscopic

removal.

• premature detachment of the capsule.

•

The safety and efficacy of the Bravo pH capsule with delivery device has not been

established for pediatric use on patients below the age of 4.

•

The Bravo pH capsule with delivery device is a single-use, disposable device. Reuse

or any other misuse of a Bravo pH capsule with delivery device such as sharp

bending or kinking) results in an increased potential for damage to the delivery

device and capsule, and possible patient injury.

•

Prior to use, all equipment for the pH study should be examined carefully to verify

proper function.

•

Unauthorized maintenance by inadequately trained personnel would result in an

unacceptable risk e.g., excessive temperatures, fire, or explosion).

•

A thorough understanding of the technical principles, clinical applications and risks

associated with the Bravo recorder is necessary before using this product. Read the

entire manual before using the system for the first time.

•

No modification of this equipment is allowed.

•

Patients are restricted from undergoing an MRI study within 30 days of the pH

study.

•

The Bravo capsule contains a trocar needle that is made of stainless steel. Use

caution in patients with known sensitivities or allergies to the metals that are

contained including chromium, nickel, copper, cobalt, and iron. The Bravo pH test

lasts from 48 to 96 hours.

Bravo pH Monitoring System 3 User Guide

hapter.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

•

Prior to the pH study, the patient should not eat or drink for a minimum of 6 hours.

•

If excretion of the Bravo pH capsule from the patient has not been positively

verified, and the patient develops unexplained postprocedure abdominal pain,

vomiting, or other symptoms of obstruction, the patient should contact the physician

for evaluation and possible abdominal X-ray.

•

Undergoing an MRI while the Bravo pH capsule is inside the patient’s body may

result in serious damage to the patient’s intestinal tract or abdominal cavity. If the

patient did not positively verify the excretion of any Bravo pH capsule, the patient

should contact the physician for evaluation and possible abdominal X-ray before

undergoing an MRI examination.

Storage

Store all components in a controlled room temperature environment:

•

capsules at 15–45 °C 59–113 °F)

•

recorder at 0–40 °C 32–104 °F)

Electromagnetic Compatibility

Electrical equipment for medical use requires special electromagnetic compatibility

EMC) precautions and should be installed and serviced according to the documentation

of device. Portable and mobile communication equipment can affect electrical equipment

for medical use. For additional information on electromagnetic compatibility, see

Electromagnetic Compatibility Declaration (EN / IEC 60601-1-2) on page 37.

Bravo pH Monitoring System 4 User Guide

hapter.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

atient Information (Benefits and Risks)

Benefits

Bravo pH monitoring system provides a more tolerable and convenient way to

evaluate your reflux symptoms when compared to catheter-based pH monitoring

systems.

The capsule is temporarily attached to the wall of your esophagus. The capsule

transmits pH information wirelessly to a small recorder that you wear. Data can be

transmitted approximately 2 meters 6 feet), which means that you can take the

recorder off to shower and sleep without interrupting the test.

You can engage in your usual activities during the test, which can provide your

doctor with a more accurate picture of your acid exposure compared to data collected

using catheter-based systems.

Risks

The Bravo pH test is not for everyone. If you have bleeding diathesis, strictures,

severe esophagitis, varices, obstructions, a pacemaker, or an implantable cardiac

defibrillator, you should not undergo a Bravo pH test. Additionally, because the

capsule contains a small magnet, you should not have an MRI study within 30 days

of undergoing the Bravo pH test.

Potential complications include, but are not limited to, the following events:

• perforation

• premature detachment of the pH capsule

• failure of the pH capsule to detach from the esophagus within several days after

placement or discomfort associated with the pH capsule, requiring endoscopic

removal

• tears in the mucosal and submucosal layers of the esophagus, causing bleeding

and requiring possible medical intervention

Potential complications associated with gastrointestinal endoscopy include:

• perforation or hemorrhage

• aspiration

• fever or infection

• hypertension

• respiratory arrest

• cardiac arrhythmia or arrest

Note

All pH testing pro edures arry some risks. This information should not

be used as a substitute for talking with your do tor about diagnosis and

treatment.

Bravo pH Monitoring System User Guide

hapter.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

System Components

The Bravo pH Monitoring System consists of the following items:

1Bravo pH recorder referred to as recorder in this user guide)

2case and shoulder strap

3USB cable

4charger

5AccuView or Reflux software, delivered separately either on media or

pre-installed on a bundled PC workstation referred to as PC in this user guide)

6Bravo pH capsule with delivery device referred to as caps le in this user guide)

7vacuum pump

8pH 1.07 and pH 7.01 calibration buffer solutions

9calibration stand

10 sterile water to be supplied by the user)

Bravo pH Monitoring System 6 User Guide

hapter.fm 3/21/16 4:05 pm

5.5 x 7.75 in hes (140 mm x 197 mm)

System Workflow

When using the Bravo pH Monitoring System, you follow this general workflow:

Charging the battery: you can charge the recorder by connecting the supplied

charger to an electrical outlet or by connecting the supplied USB cable to your PC.

Recorder setup: this includes setting the date and time and defining the default

settings for studies. You only need to do it once though values can be changed later

as needed). See Setting the Date and Time on page 11.

Calibration: this includes making sure that the capsule is correctly reading the pH

levels. You do this for every study. See Calibrating Caps les on page 13.

Capsule placement: this includes performing the procedure of positioning and

attaching the capsule in the patient. See Placing the Caps le on page 21.

Patient instructions: this includes reviewing information about the study with the

patient, such as instructions on using the recorder and filling out the patient diary.

See Reviewing Instr ctions with Patients on page 26.

Study duration: this includes the patient wearing the recorder for the study

duration.

Data upload: this includes transferring the study data from the recorder to the PC

for analysis in the application software. See Uploading pH Data on page 28.

You must also become familiar with the basic workings of the recorder, including normal

maintenance functions such as recharging and cleaning. See Bravo pH Recorder on page 7

and Recorder Maintenance on page 29.

Note

The re order always defaults to the expe ted a tion in the workflow. For

example, if the alibration pro ess has been ompleted su essfully, the

re order menu ursor automati ally points to Start Study. This simplifies the

pro ess and redu es the risk of errors. However, you an manually sele t

another menu option at any time.

Inhaltsverzeichnis

Andere Given Imaging Messgerät Handbücher

Given Imaging

Given Imaging PillCam DR3 Bedienungsanleitung

Beliebte Messgerät Handbücher anderer Marken

Suaoki

Suaoki D40 Bedienungsanleitung

Elster

Elster BK-G1.6 Bedienungsanleitung

Endress+Hauser

Endress+Hauser Deltabar FMD71 Handbuch

Duratool

Duratool D03128 Bedienungsanleitung

Vega

Vega VEGAPULS 65 Bedienungsanleitung

Tonghui

Tonghui TH2618B Bedienungsanleitung

Tenmars

Tenmars TM-801 Bedienungsanleitung

MSR

MSR 145 Bedienungsanleitung

TPS

TPS WP-82 Bedienungsanleitung

ELMETRON

ELMETRON CP-511 Bedienungsanleitung

PCB Piezotronics

PCB Piezotronics 003C30 Bedienungsanleitung

Tenma

Tenma 72-10465 Bedienungsanleitung

Endress+Hauser

Endress+Hauser Proline Promag 50 Technische Daten

Siemens

Siemens SITRANS F Coriolis FCT030 Stücklistenhandbuch

KLINGER

KLINGER CMF V Series Bedienungsanleitung

EXFO

EXFO FTB-2 Bedienungs- und Wartungshandbuch

Keysight

Keysight M8290A Bedienungsanleitung

ADTEK

ADTEK MW-5 Bedienungsanleitung