Mui Scientific Rapid Barostat Bag User manual

RAPID BAROSTAT BAG PUMP
REF
P1 –RBB –1
Mui Scientific
Manual P5-K-104, Revised March 1, 2021
CAUTION: Federal Law (U.S.) restricts the sale of this device to, or by the order of a physician.
Mui Scientific
145 Traders Blvd. E., Unit #34
Mississauga, Ontario
Canada L4Z 3L3
Tel: [phone]
Toll Free: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.muiscientific.com
EC REP
Advena Ltd.
Tower Business Centre, 2nd Floor
Tower Street, Swatar, BKR 4013,
Malta
USER MANUAL

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Before Using the Pump 1
Introduction 2
Safety Information 5
Operating Requirements 5
Electrical Requirements 7
General Specifications 7
Wireless Interference Prevention 7
Applicable Standards and Warning Symbols 8
Warning Statements and Warning Symbols 9
Getting Started 10
RBB Pump Components 11
Using the Power Adaptor 15
Remote Control Battery 16
Powering On the RBB Pump 17
Pairing the RBB Remote Control 19
First Time Setup 21
Setting Up Password Protection 21
Default Pump Settings 23
Uploading Hospital Logo 24
Setting the Time and Date 26
Changing Keyboard Language 27
Operating Instructions 28
Patient Information 29
Adding a New Patient Profile 29
Editing Patient Information 30
Before Performing a Test 31
Toggling the Disable Button 31
Connecting the RBB Catheter 32
Performing an RBB Test 33
Starting a New Test 33
Performing a Capacity Test 34
Performing a Sensation Test 38
Navigating a Test Report 41
Viewing a Test Report 41
Hiding Sensation Cycles 43
Changing the Compliance Value 45
Editing Fields 47
Exporting Files 48
Exporting a Test Report to a USB 48
Exporting a Test Report to a Computer 50
Exporting Multiple Test Reports 52
Export Multiple Patients’ Test Reports 53
Taking Screenshots 54
Erasing Data and Default Setting 56
Service and Maintenance 58
Care and Maintenance 59
Volume Verification 60
Resetting Password 64
Updating Software 65
Troubleshooting 67
Replacement Parts 70
Appendices 72
TABLE OF CONTENTS

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1
RAPID BAROSTAT BAG PUMP
Mui Scientific
BEFORE USING THE PUMP

2
The Rapid Barostat Bag (RBB) Pump is a portable, bedside medical device
used for evaluating Rectal Motor and Sensory Function. It provides accurate
and consistent readings of a patient’s rectal capacity, pressure, compliance,
and sensation by performing the RBB Test and categorizing patients as
having hypo-/normal/hyper-sensitivity based on established percentages.
The RBB Test is a simple two-step rectal barostat procedure (streamlined by
Dr. Mark Fox of the University of Zurich) to provide accurate readings of a
patient’s rectal motor and sensory functions within 10 minutes. The RBB Tests
consist of the Capacity Test followed by the Sensation Test. The RBB Pump
and Catheter are used together for the inflation of a Barostat Bag to measure
Rectal Capacity, Pressure, Compliance and Sensitivity. These findings, in
conjunction with normal values established by Dr. Fox can aid in the diagnosis
of anorectal disorders, such as fecal incontinence and constipation, as well as
aid in surgical pre-screening, biofeedback training, and determining rectal
sensitivity of Inflammatory Bowel Disease and Irritable Bowel Syndrome
patients.
The RBB Pump uses a battery-operated air compressor, designed to inflate a
Barostat Bag at the default rate of 120 mL/min. The pump is operated through
a touch screen, which actively displays the data collected during an RBB Test.
At the end of the test, a report is generated by the pump, which can then be
exported to an external USB Mass Storage Device. Raw data collected during
the test can also be exported for research purposes.
The RBB Pump includes a Bluetooth handheld remote control. During the
Sensation Test, patients are requested to identify 3 different sensitivity stages:
Sensation, Urge and Discomfort. Using the remote control, patients can
provide a direct input to the pump, reducing data latency. Operators of the
pump can also provide these inputs directly into the pump for the patients, if
the patients are unable to do so, or if the remote control fails to work.
In an emergency, the pump utilizes a Disable Button that immediately
deactivates all internal components inside the pump. A valve is opened
internally to allow all air from the Barostat Bag to escape, preventing any
potential harm to the patient.
*M. Sauter, H. Heinrich, M. Fox, B. Misselwitz, M. Halama, W. Schwizer, M. Fried, H. Fruefauf. (2014). Validation of High-
Resolution Anorectal Manometry and Rapid Barostat Bag measurements of rectal function. In M. Simren, G. Mawe, J. Galligan
(Eds.). Neurogastroenterology & Motility (vol. 26, pp. 685-695)
INTRODUCTION

3
a) Intended Use
The RBB Pump and Catheter are used together for the inflation of a barostat
balloon to measure rectal capacity, as well as rectal volume at points of sensation,
urge, anddiscomfort, to determine hypersensitivity, hyposensitivity, or normal rectal
sensations. Thesedeterminations aid in the diagnosis of anorectal disorders, such
as fecal incontinence and constipation.
TheRBB Pumpshould beusedinamedical settingbymedicalpersonnel who
havereceivedprofessional training in gastrointestinal manometry.
b) Indication for Use
Use of the RBB Pump together with the RBB Catheter is indicated when
there is aneedor suspicion of an anorectal disorder or for evaluating
other Rectal Motor Sensory Function.
c) Contraindication for Use
The presence of anystenosis, structural deformityor disease within the rectum,
that results in an unacceptably increased risk of distention, perforation, or any
other adverse consequence arising from use of this assembly.
d) Warnings
These devices are supplied non-sterile.
Proper aseptic technique and universal barrier precautions (UBP) must apply.
Follow RBB Catheter IFU for correct catheter placement.
The RBB Catheters are designed for single-use only. Attempts to reprocess,
resterilize, and/or re-use may lead to failure of the device and/or cross-
contamination.
Post-procedure RBB catheters are contaminated with body
fluid. Immediately dispose of device to prevent re-use.
Read through entire manual to reduce any possible risks from misuse.
Labels on outer surface of RBB pump may fade from cleaning materials.
Follow instructions in manual.
INTRODUCTION
INTRODUCTION

4
The RBB Pump must be used in a hospital setting and should be operated by a
qualified medical professional trained in gastrointestinal manometry. Placing
the RBB pump or the charging dock on a wet surface may cause short
circuiting of RBB system or short circuiting of lithium batteries.
Spilling water on or in the pump or charging dock may lead to
electric shock to the operator and/or patient, as well as electrical
damage to facility wiring.
Refer to further information under section “Safety Information” for
more specific details regarding operating, electrical, and Bluetooth
requirements to ensure safe and optimal use.
Refer to further warnings under section “Before Performing a Test”
regarding software.
Follow instructions under section “Volume Verification” to ensure
optimal performance of the volume and pressure sensors.
Refer to the RBB Pump’s Operating Manual for more specific
details regarding operating and electrical requirements.
The RBB pump and catheter must not be altered or modified in any
way. Mui Scientific is not liable for personal injury and damage to
property if original Mui Scientific parts are not being used. Instructions
should always be followed as stipulated in the RBB Pump's
Operating Manual.
The RBB Pump has a prescribed lifetime of 10 years.
The RBB Catheter has a prescribed lifetime and shelf life of 2 years.
Dispose of the device safely, in accordance with the local policies
where this device shall be used.
User is to contact the manufacturer or competent authority to report
serious incident involving this device.
Target Populations
There are no specific intended patient populations.
The use for specific patients is at the discretion of the medical personnel who
have received professional training in gastrointestinal manometry.

5
Operating Requirements:
Read all of the information in the user manual before operating the RBB
Pump.
Only perform a test in the presence of authorized medical personnel.
Performing a Sensation Test requires input from the patient. Do not use
this device on infants or patients who cannot communicate their sensation.
Operate the device only as intended. Do not use the device for any other
purposes.
Only use the RBB Catheter with the RBB Pump.
Do not operate the device in the presence of flammable or anaesthetic
gas.
Do not continue to use the device and if the volume and/or pressure
readings are deemed inaccurate, contact Mui Scientific for assistance.
The summary findings and data analysis from the RBB Pump should not
be interpreted as a final diagnosis for the patient.
Ensure the device is cleaned properly before every patient use to ensure
no cross-contamination (refer to pg. 54 for cleaning instructions).
To avoid interference with other wireless devices, follow the
recommended separation distance when operating the device (refer to
Appendix D, pg. 69).
Do not disassemble the RBB Pump under any circumstances. Contact
Mui Scientific for any technical support.
RBB Pump should only be used by trained operators and Mui Scientific is
not responsible about the consequences initialed by untrained personnel.
SAFETY INFORMATION

6
DISCLAIMER:
Depending on jurisdiction, the pump operator may be responsible for the
prevention of unauthorized access and protection of patient data. If this
requirement applies, it is recommended that the pump operator delete
patient data from the pump prior to sending it for servicing. In such a case,
it is the responsibility of the pump operator to back up any patient data.
Mui Scientific is not responsible for maintaining data integrity during pump
servicing, and will not copy, back up, or intentionally manipulate any
patient data that is stored on RBB Pumps that are received for servicing.

7
Electrical Requirements:
Input: 100 –240 VAC, 50/60 Hz, 1.0 –0.5 A
Output: 5 V 5.0 A, 25 W MAX.
North American Type A Power Cord Included
General Specifications:
Overall Pump Dimensions (including charging station):
Height: 28 cm (10 ¾”)
Width: 27 cm (10 ¾”)
Depth: 14 cm (5 ½”)
Weight:2.27 kg (5 lbs)
Operating Environment Ratings:
10 –40C;30 –75 % RH non-condensing; 80 –106 kPa
Wireless Interference Prevention:
The RBB Pump uses Bluetooth 4.1 Technology to communicate with its
handheld remote control device. To prevent the pump or its remote control
from wirelessly interfering with other wireless devices, both devices must
operate within the recommended separation distance requirements specified
in Appendix D (pg. 59).
The RBB Pump and remote control both use the same Bluetooth module that
emits a maximum RF power of 7.5 dBm (5.6 mW) at 2.4 GHz during active
operation, and have an effective communication distance within 6 m of each
other. Using Appendix D for comparison, the pump and remote control are
recommended to have a separation distance of 0.24 m from other wireless
devices during active operation.
SAFETY INFORMATION

8
Applicable Standards:
Standard/Document Name
Description
93/42/EEC
Council Directive concerning medical
devices as amended by Directive
2007/47/EC
EN 1041:2008
Information supplied by the
manufacturer of medical devices
EN ISO 13485:2016
Medical Devices –Quality
Management Systems –
Requirements for Regulatory
Purposes
ISO 14971:2019*
Medical Devices –Application of Risk
Management to Medical Devices
EN ISO 15223-:2016
Medical Devices-Symbols to be used
with medical device labels, labelling
and information supplied-
Part1:General requirements
EN 1041:2008+A1:2013
Information supplied by the
manufacturer of medical devices
EN 60601-1:2015/A1:2013
Medical electrical equipment —
General requirements for basic safety
and essential performance
EN 60601-1-2:2014
Electromagnetic disturbances
requirements and tests (EMC)
IEC 60601-1-6: 2013
General requirements for basic safety
and essential performance: Usability
BS EN 62304:2006+A1:2015
Medical device software –software life
cycle processes
EN 62366-1:2015
Part 1: Application of usability
engineering to medical devices
Equipment Classification:
Class II with respect to protection from electric shock.
Type BF with respect to degree of protection from electric shock.
Ordinary degree of protection against ingress of liquids.
SAFETY INFORMATION

9
WARNING: PLEASE FOLLOW THESE SYMBOLS AND INSTRUCTIONS CAREFULLY
TO REDUCE RISK OF FIRE OR EQUIPMENT FAILURE
Equipment not suitable for use in the presence of a flammable anaesthetic mixture.
Ground reliability is only achieved when the equipment is connected to a receptacle
marked “Hospital Only” or “Hospital Grade”.
Do not perform maintenance or service while device is in use.
Keep charging dock and power supply cord in a place free of other equipment –power
supply must be easy to disconnect from the outlet.
Do not modify equipment.
Warnings –Refer to Appendix A, B, C, D (pg. 55)
DO NOT USE IF PACKAGE IS DAMAGED NON STERILE NON-DEHP
When packed for transport from factory, equipment will withstand
Warning Statements and Warning Symbols:
SAFETY INFORMATION
TYPE BF APPLIED
REFER TO INSTRUCTION MANUAL/BOOKLET
ATMOSPHERIC PRESSURE RANGE 50 kPa TO 106 kPa
RELATIVE HUMIDITY RANGE 10 % TO 100 %
AMBIENT TEMPERATURE RANGE 0°C TO + 40°C

10
RAPID BAROSTAT BAG PUMP
Mui Scientific
GETTING STARTED

11
RBB Pump package includes:
RBB Pump and Charging Dock –Front View:
RBB PUMP COMPONENTS
Verification Bag
Power Adaptor
and Power
Cord, Class II
RBB Remote
Control and Dock
RBB Pump and
Charging Dock
Disable Button
Metal Luer
Touch-enabled
Display Window
Power LED
Indicator
Charging LED
Indicator
Demo Tube
Carrying Case

12
RBB Pump and Charging Dock –Back Left View:
RBB Pump and Charging Dock –Back Right View:
RBB PUMP COMPONENTS
Charging Dock
USB Mini
Type B
Connector
Air Vent
Air Vent
Power Button
USB Type A
Connector
Adaptor Jack

13
Power Adaptor and Power Cord, Class II:
RBB Remote Control and Dock:
RBB PUMP COMPONENTS
AC/DC Medical Adaptor
North American Type A
Power Cord (Exchangeable
for other countries)
Power Adaptor Plug
LED Indicators
Tactile Buttons
Remote Control Dock

14
Verification Bag:
Carrying Case:
RBB PUMP COMPONENTS
Demo Tube:
Stop Cap
Mui Scientific

15
Connecting the Power Adaptor:
1) Insert Adaptor Plug into the Adaptor Jack on the bottom right side of the
Charging Dock as illustrated.
2) Plug the Power Adaptor into any standard wall electrical outlet.
3) Both BLUE and RED LED Indicators at the front of the RBB Pump should
light up, indicating that the pump is charging.
4) When the pump is fully charged, the RED LED will automatically turn off.
Disconnecting the Power Adaptor:
1) Unplug the Power Adaptor from the wall electrical outlet.
2) Remove the Power Adaptor from the Charging Dock.
NOTE: The RBB Pump can operate for 4 hours of continuous operation and
its charge can last for 4 months without use. Please charge the pump
overnight before using if it is kept in storage for more than 4 months.
USING THE POWER ADAPTOR
Charging
Fully Charged
WARNING: PLEASE FOLLOW THESE INSTRUCTIONS CAREFULLY
TO REDUCE RISK OF FIRE OR ELECTRIC SHOCK
Use only the authorized RBB Adaptor provided in the package.
For connection to a power supply outside of North America, use the
appropriate Standard Power Cord for the respective country/region.
Do not plug or unplug the power cord into electrical outlet with wet
hands.
Adaptor Plug
Adaptor Jack
Power LED
Indicator
Charging LED
Indicator

16
Installing Remote Control Batteries:
1) Unscrew the Back Screw on the back of the RBB Remote Control Case.
2) Separate the Front Piece of the RBB Remote Control Case.
3) Unscrew the Battery Holder inside the case.
4) Insert 2 AAA Batteries into the
battery compartment. Ensure
that the + and –terminals on the
battery matches with the
polarities labeled in the battery
compartment.
5) Reassemble the Remote
Control by replacing the Battery
Holder, Front Piece and Back
Screw back to their original
position.
REMOTE CONTROL BATTERY
INSTALLATION
Battery Holder
Front Piece
Back Screw
+ Positive
Terminal
AAA Battery
–Negative
Terminal