Belmont Allon User manual

Allon®
User Manual
DDT-063-000 Rev C English

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 2 of 106
Conformity according to the Council Directive 93/42/EEC
Manufacturer’s Name
Belmont Medical Technologies
780 Boston Road
Billerica, MA 01821 USA
Technical Service
885-397-4547 (USA)
[phone] (WORLDWIDE)
www.BelmontMedTech.com
European Representative:
Emergo Europe BV
Prinsessegracht 20
2514 Ap The Hague
The Netherlands
[phone]
Copyright 2020 by Belmont Medical Technologies. All RIGHTS RESERVED
Registered trademarks are the intellectual property of their respective holders.

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 3 of 106
Use of Manual
The purpose of this manual is to help qualified personnel understand and
operate the system. It is important that you read this manual and familiarize
yourself thoroughly with its contents before you attempt to operate the system. If
you do not understand any part of this manual, or if anything is unclear or
ambiguous in any way, please contact your Belmont Medical Technologies
representative for further clarification.
The Allon 2001®system described in this manual has been designed to meet
international safety and performance standards. Only qualified personnel may
operate the system, and these operators must first have a full understanding of
the proper operation of the system.
The information provided in this manual is not intended to replace regular
medical training procedures.
This manual should always accompany the system. All qualified personnel
operating the system should know the location of the manual. For additional
copies of this manual, please contact your Belmont Medical Technologies
representative.
Training
Belmont Medical Technologies or its authorized distributor will provide training
for the system user according to the intended use of the device or system.
It is the responsibility of the end user to ensure that only users trained to use the
equipment efficiently and safely, operate the equipment.
Operator Profile
Connections and device settings should, typically, be performed by a clinician
expert in thermoregulation.
Important Notice
No part of this manual may be reproduced or copied in any form by any graphic,
electronic, or mechanical means - including photocopying, scanning, typing or
information retrieval systems - without advanced written permission from Belmont
Medical Technologies.
Patent Nos. US 6,500,200 B1, US 5,508,831 B1, US 6,685,731 B1
NOTE: All instructions regarding the reusable temperature probes
are NOT applicable for use in the USA market and other
select markets.

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 4 of 106
Disclaimer
Belmont Medical Technologies is not responsible for any consequential or incidental
damages or expenses of any kind, impairment of or damage to other goods caused
by the following:
a. Installed, operated, maintained contrary to Belmont Medical Technologies
instructions, notes, or warnings under this manual.
b. Ignoring any of the warnings, precautions and safety measures indicated in this
manual.
c. Replacement, repair or alteration not performed by Belmont Medical
Technologies or authorized personnel.
d. The use of accessories and other parts or equipment made by other
manufacturers, whether or not warranted by such manufacturers, which have
been attached or connected to the System after installation, unless such
accessories and other parts have been supplied and attached or installed by
Belmont Medical Technologies.
e. Using the system in a contrary manner than indicated in this manual or using the
system for any purpose other than indicated in the manual.

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 5 of 106
TABLE OF CONTENTS
Disclaimer.................................................................................................................................................4
CHAPTER 1: SAFETY PRECAUTIONS ................................................................................................... 8
Intended Use ............................................................................................................................................8
Warnings ..................................................................................................................................................8
Precautions...............................................................................................................................................9
Labels .....................................................................................................................................................11
CHAPTER 2 SYSTEM DESCRIPTION ...................................................................................................14
General Description ................................................................................................................................ 14
Allon® System ........................................................................................................................................14
External Features ................................................................................................................................... 16
Accessories ............................................................................................................................................24
System Specifications.............................................................................................................................28
SPECIFICATIONS ................................................................................................................................................... 29
CHAPTER 3: INSTALLATION ................................................................................................................32
Pre-installation Requirements ................................................................................................................. 32
Moving the Unit.......................................................................................................................................35
CHAPTER 4: OPERATING INSTRUCTIONS ......................................................................................... 36
Control Panel ..........................................................................................................................................37
Getting Started........................................................................................................................................38
Main Screen............................................................................................................................................43
Menu Options .........................................................................................................................................44
Turning off the System............................................................................................................................60
CHAPTER 5: ORDERING INFORMATION ............................................................................................. 62
Equipment and Accessories.................................................................................................................... 62
CHAPTER 6: MAINTENANCE ................................................................................................................ 65
Introduction.............................................................................................................................................65
Service Information .................................................................................................................................65
Routine Maintenance ..............................................................................................................................65
Cleaning and Disinfection .......................................................................................................................66
Routine Maintenance ..............................................................................................................................67
Cleaning, Disinfecting and Sterilization of the Reusable Temperature Probes ........................................ 70
Filter Replacement..................................................................................................................................71
System Check Service............................................................................................................................ 71
CHAPTER 7: TROUBLESHOOTING ......................................................................................................74
General...................................................................................................................................................74
Troubleshooting Guide............................................................................................................................74
CHAPTER 8: MESSAGES AND ALARMS..............................................................................................82
Technical Messages and Alarms ............................................................................................................ 82
Clinical Messages and Alarms ................................................................................................................ 84
Safety Messages and Alarms ................................................................................................................. 85
Informative Messages.............................................................................................................................86
CHAPTER 9: OPTIONAL CLINILOGGER™ ........................................................................................... 88
INSTALLATION AND OPERATING INSTRUCTIONS............................................................................. 88
Overview and Installation ........................................................................................................................88
Using the CliniLogger™ Viewer Application ............................................................................................ 92
APPENDIX A: CUSTOMER SERVICE.................................................................................................. 104
APPENDIX B: RF SEPARATION.......................................................................................................... 105
APPENDIX C: DECLARATIONS OF COMPLIANCE ............................................................................ 106

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 6 of 106
LIST OF TABLES
Table 1: Label Symbols ..........................................................................................................................12
Table 2: Label Symbols ..........................................................................................................................13
Table 3: ThermoWrap® Sizes.................................................................................................................23
Table 4: Disposable Sensors ..................................................................................................................26
Table 5: Reusable Sensor and Data Provider Input Specifications.......................................................... 26
Table 6: ThermoWrap® Sizes.................................................................................................................62
Table 7: Allon® Accessory Kits ............................................................................................................... 63
Table 8: Accessories Individual Replacement ......................................................................................... 64
Table 9: Inspection and Maintenance Schedule...................................................................................... 66
Table 10: Allon® System (No Message) Troubleshooting Guide............................................................. 75
Table 11: Water Tank Overfilled- Draining the Water Tank ..................................................................... 76
Table 12: Allon® System Messages Troubleshooting Guide................................................................... 77
Table 13: Technical Messages and Alarms.............................................................................................82
Table 14: Clinical Messages and Alarms ................................................................................................84
Table 15: Zoom Tool Buttons..................................................................................................................98
Table 16: Mode Codes..........................................................................................................................100
Table 17: Separation Distances in Meters............................................................................................. 105
Table 18: Electromagnetic Emissions – for all ME Equipment and ME Systems ................................... 106

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 7 of 106
LIST OF FIGURES
Figure 1: Label Placement for the Allon Device .......................................................................................................... 11
Figure 2: Front View .................................................................................................................................................... 16
Figure 3: Side View ..................................................................................................................................................... 17
Figure 4: Rear View..................................................................................................................................................... 18
Figure 5: Cardiac ThermoWrap® ................................................................................................................................ 21
Figure 6: Universal ThermoWrap® ............................................................................................................................. 21
Figure 7: Universal (Pediatric) ThermoWrap® ............................................................................................................ 21
Figure 8: Infant ThermoWrap®.................................................................................................................................... 21
Figure 9: Measurements ............................................................................................................................................. 22
Figure 10: Disposable Sensor Connections................................................................................................................ 26
Figure 11: Temperature Splitter .................................................................................................................................. 28
Figure 12: Handle Assembly ....................................................................................................................................... 34
Figure 13: Control Panel ............................................................................................................................................. 38
Figure 14: Initial Self-Test Screen ............................................................................................................................... 39
Figure 15: Preheating Water ....................................................................................................................................... 40
Figure 16: Main Screen- Default Normothermia ......................................................................................................... 43
Figure 17: Menu Options............................................................................................................................................. 44
Figure 18: Stand-by Mode........................................................................................................................................... 45
Figure 19: Mode Select ............................................................................................................................................... 46
Figure 20: Select Set Point Temperature.................................................................................................................... 47
Figure 21: “Out of Normothermia” Message ............................................................................................................... 48
Figure 22: Manual Mode Screen ................................................................................................................................. 49
Figure 23: Select Water Out Temperature .................................................................................................................. 49
Figure 24: Temp Graph Mode ..................................................................................................................................... 50
Figure 25: Settings Screen.......................................................................................................................................... 52
Figure 26: All Temp Sensors Alarm Off Indicator........................................................................................................ 53
Figure 27: Adjustable Alarm Limits.............................................................................................................................. 54
Figure 28: Set Date and Time ..................................................................................................................................... 55
Figure 29: Services Screen ......................................................................................................................................... 56
Figure 30: Empty Mode ............................................................................................................................................... 57
Figure 31: Empty Mode ............................................................................................................................................... 57
Figure 32: Tank is Empty ............................................................................................................................................ 58
Figure 33: Thermal Disinfection Mode ........................................................................................................................ 60
Figure 34: Selecting System Check ............................................................................................................................ 72
Figure 35: System Check in Progress......................................................................................................................... 72
Figure 36: ThermoWrap® Connecting Tubes and Special Male Connector............................................................... 76
Figure 37: CliniLogger™ Initialization.......................................................................................................................... 89
Figure 38: CliniLogger™ Installation ........................................................................................................................... 89
Figure 39: CliniLogger™ Agreement........................................................................................................................... 90
Figure 40: Start Installation ......................................................................................................................................... 90
Figure 41: Installation Progress................................................................................................................................... 91
Figure 42: Installation Complete.................................................................................................................................. 91
Figure 43: CliniLogger™ Application Window............................................................................................................. 92
Figure 44: CliniLogger™ Window................................................................................................................................ 93
Figure 45: CliniLogger™ Window................................................................................................................................ 94
Figure 46: “Complete” Message.................................................................................................................................. 94
Figure 47: CliniLogger™ Viewing Panel ..................................................................................................................... 95
Figure 48: Graphics Display Area ............................................................................................................................... 96
Figure 49: Function Selection Area ............................................................................................................................. 97
Figure 50: Example Modes and Errors Area............................................................................................................... 97
Figure 51: Zoom Toolbar............................................................................................................................................. 98
Figure 52: Example of “Modes and Error Area” ........................................................................................................ 100
Figure 53: Selection of Graph Chart ......................................................................................................................... 103

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 8 of 106
CHAPTER 1: SAFETY PRECAUTIONS
Definitions
WARNING!!! Indicates a condition that may endanger the patient or the
system operator.
CAUTION! Indicates a condition that may damage the equipment.
NOTE: Indicates ways in which the system’s operation can be made
more efficient.
Intended Use
Allon®is intended to maintain pre-set body temperature as determined by the physician.
It can also be utilized to maintain normal body temperature during surgical procedures.
This system can be used for adult and pediatric patients.
Warnings
1. The physician must be notified if the patient's temperature does not respond
properly, does not reach the prescribed temperature, or if there is any change in
the prescribed temperature range. Failure to inform the physician may result in
injury to the patient.
2. The patient should be under constant supervision of the medical staff.
3. The misuse of the temperature regulation equipment can be potentially harmful to
the patient.
4. Do not plug wet probes into the sockets of the Allon®device.
5. The user should verify that no fluids are present at the skin/wrap interface during
the procedure. Failure to do so can cause lesions on the patient's skin. Following
the procedure, a pattern resembling the wrap may appear for a short period of
time on the patient's skin.
6. Pressure sores may appear or develop when soft tissue is compressed between a
bony prominence and external surface. The use of the Allon®system does not
prevent this from happening.
7. In order to prevent pressure sores, hospital routine care should be taken during
long thermoregulation procedures.
8. Do not lift or move the patient by means of the Wrap. This may cause tearing and
water leakage from the Wrap.
9. Use only probes or adapters suppliedby Belmont Medical Technologies.
10. The technical principles, clinical applications, and risks associated with

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 9 of 106
circulatory support must be thoroughly understood before using this
product.
11. Read the entire manual before attempting to activate the system.
12. Completion of the training program prior to using the Allon®system is
mandatory.
13. The repair, calibration, and servicing of the Allon®system should be
performed only by Belmont Medical Technologies or authorized agents
trained by Belmont Medical Technologies.
14. Prevent any thermal isolation, such as a pillow or other items,
between the ThermoWrap®and the patient's body.
15. Do not apply heating/cooling to lower extremities during aortic cross
clamping. Thermal injury may occur if heating/cooling is applied to
ischemic limbs.
16. Wraps should not be placed over transdermal patches.
17. Wrap should not come in contact with open wounds.
18. Do not touch the ribbon cable behind the display and the patient
simultaneously.
Precautions
1. Follow the warning notes listed in the various sections of this manual.
2. Only trained personnel, familiar with all system operating procedures
and certified only by Belmont Medical Technologies or authorized
agents of Belmont Medical Technologies are allowed to use the
Allon®system. All hospital personnel using the Allon®system must
complete the Allon® training program.
3. If moisture or leaks are discovered in the connecting hose and/or
Wrap, turn off the Allon®device, disconnect the power cable from its
power source, and correct the problem before proceeding.
4. The desired set-point temperature should be fixed only as prescribed
by and under the order of a physician.
5. The default setting is intended to maintain Normothermia. The system
provides the physician with the option of selecting a body temperature
in the range of 30°C to 40°C (86°F-104°F).

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 10 of 106
6. If the device sounds an alarm and/or presents a display other than the
standard Belmont Medical Technologies display, the operator should
proceed according to the display message and/or the troubleshooting
instructions (see Chapter 7: Troubleshooting).
7. Avoid folds in the Wrap—these may obstruct water flow.
8. Do not block the Allon®device ventilation grilles. Air must be able to
flow freely in and out to keep the device cool.
9. Use sterile or 0.22µ filtered water. Do not use de-ionized water or
water created through reverse osmosis because it may promote
corrosion of the metal components of the system.
10. When X-ray imaging is performed on a patient wearing a Wrap,
shadows from the Wrap may appear on the X-ray film.
11. Avoid inserting any sharp object between the patient and the Wrap.
12. Storage of Wraps is recommended at temperatures 10°C to 27°C and
10%-90% humidity.
EMC Safety
For safe use of the Allon®, it is required to keep the Allon®at a safe distance
from devices emitting radio frequency energy.
Refer to Appendix B for recommended separation distances between the
Allon®and RF source.
WARNING!!! To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth.
CAUTION! Power interrupts affect the functionality of the system,
depending on the mode of operation:
•Interruptions longer than 10 minutes return the
machine to the Start-up Screen. An alarm will sound
when the power is returned to indicate that the
machine has returned to the Startup screen.
•Interruptions shorter than 10 minutes return the
machine to the mode that was operating before the
interruption, but a warning will appear.
NOTE: Make sure to read the messages to ensure correct
reactivation of the machine.
NOTE: Do not position equipment in a location that will make it
difficult to operate equipment.

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 11 of 106
Figure 1: Label Placement for the Allon Device
Improper Use
Improper use of the Allon®system can lead to skin lesions, electrical
hazards, and severe changes in body temperature.
WARNING!!! The technical principles, clinical applications, and risks
associated with circulatory support must be thoroughly
understood before using this product. Read the entire
manual before attempting to activate the system. Completion
of the training program prior to using the Allon® system is
mandatory.
CAUTION! U.S. Federal law restricts this device to sale by or on the
order of a physician.
Labels
Allon®Device Labels

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 12 of 106
Label Symbols
Table 1: Label Symbols
Description Symbol
AC Voltage
Fuse
CE mark of conformity indicates that the product has
received the European approval for MDD 93/42/EEC.
Refer to user manual
Type BF equipment
Recycle for WEEE

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 13 of 106
Table 2: Label Symbols
Description Symbol
Date of manufacture
XX/XX/XXXX
Manufacturer Name
Do not push
Refer to Instruction manual / booklet
Restricts the sale and use of this instrument to qualified
medical personnel only.
Use sterile or 0.22 µ filtered water only. Tap water usage is
not permitted.

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 14 of 106
CHAPTER 2 SYSTEM DESCRIPTION
General Description
The Allon®system maintains desired patient body temperature before, during
and after surgery. The desired patient temperature is set by the clinician and
covers the normothermia to hypothermia range. Most surgical procedures
require normothermia in order to compensate for body heat losses resulting
from general anesthesia, reduced metabolic rate and exposure of body organs
and skin to the cold operating theatre environment.
The system is composed of two elements, the Allon®device and the
ThermoWrap®disposable wrap. The Allon®device performs the functions of
heat pump, water circulating pump, and control unit.
The control unit constantly monitors the patient's core temperature every 133
milliseconds through specific sensors and, using its on-board body
temperature control algorithm, adjusts water temperature to the desired set
point. The heat pump brings the water to the required temperature and the
pump circulates it to the wrap. The touch screen allows the user to change
settings in an easy and convenient way.
The ThermoWrap®wrap is a flexible heat exchanger through which the water
circulates. It is designed to be in close contact with a large area of the body,
thus effecting heat transfer with the body. ThermoWrap are single use,
disposable and come in a variety of shapes and sizes to address various types
of surgical procedures and patient.
The device can prewarm the wrap from 23°C to 37°C in less than 5 minutes.
Allon®System
The Allon®system consists of the following elements:
–Allon®device
–ThermoWrap®
–Accessories

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 15 of 106
Allon®Device
The Allon®device has a microprocessor that controls the water temperature
flowing into the ThermoWrap®worn by the patient. The algorithm to correct the
water temperature is based on the desired set point temperature and the
actual measured patient temperature (Core and Surface).
Water pressure and flow in the wrap is regulated by timed pauses of the flow
during clinical operation.
During the initial phase of regulation, the flow cycle is 12 minutes ON and 1
minute OFF.
In steady state (when the Core Temperature is within the Set Point range), the
cycle is 12 minutes ON and 12 minutes OFF.
The Allon®is equipped with a handle for easy transport.

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 16 of 106
External Features
Front View
Water Level
Indicator
Water-out
Quick Coupling
Connector
Core Sensor
Socket
Adjustable
Control Panel
Handle
Surface Sensor
Socket
Water-In
Quick Coupling
Connector
Water-Tank
Cap
Power Loss
Indicator
Figure 2: Front View

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 17 of 106
Side View
Figure 3: Side View

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 18 of 106
Rear Panel
Figure 4: Rear View

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 19 of 106
ThermoWrap®
General
The ThermoWrap®is a one-piece wrap with one inflow and one return water
connection. It is designed to facilitate the wrapping of individual parts of the
body (chest, arms, thighs, etc.) to maximize surface coverage.
Description and Intended Use
The ThermoWrap® garment is a flexible heat exchanger through which the water
circulates.
ThermoWrap®is:
–Disposable
–Biocompatible
–Latex free
–Antistatic
–Adjustable
Each section of ThermoWrap®is separately wrapped around the appropriate
area of the patient (e.g. chest, arms and thighs) to ensure maximum body
surface coverage.
The water's exit and entrance points are short sections of tubing integrated
with a Quick Coupling Connector (QCC) and welded to convenient locations
on the edges of the ThermoWrap®.
The ThermoWrap®design allows the physician to leave bare different body
parts as dictated by the surgical procedure.
ThermoWrap®is available in a range of sizes and designs (depending on
surgery type) to optimize body coverage.
ThermoWrap®is secured to the patient via pressure sensitive adhesive strips
that adhere to the wrap.
CAUTION!! The wraps are designed for single patient use only.
Reusing may cause cross contamination and/or
irritation.

Allon®User Manual
DDT-063-000 Rev C Belmont Medical Technologies Page 20 of 106
Wrap Material
•Patient side: Non-Woven Polypropylene
•Exterior: Brushed Loop Fabric
Usage Duration
The wrap is durable for up to 28 hours. It is recommended to replace the wrap if
it becomes soiled.