Hospitech Respiration AG100s User manual
AG100s
Operator's Manual
Distribuidor exclusivo de
AG100s
Hospitech Respiration Ltd.
Operator’s Manual
BK0001 Rev. 6 Dec 20 2017
SW version 2.3.2
Copyright © 2014 Hospitech Respiration Ltd. All rights reserved.
Hospitech Respiration Ltd. reserves the right to make changes to its products or specifications to
improve performance, reliability, or manufacturability. Information furnished by Hospitech
Respiration Ltd. is believed to be accurate and reliable. However, Hospitech Respiration Ltd.
assumes no responsibility for its use. No license is granted by its implication or otherwise under
any patent or patent rights of Hospitech Respiration Ltd.
No part of this document may be produced or transmitted in any form or by any means, electronic
or mechanical, for any purpose, without the express written permission of Hospitech Respiration
Ltd.
Data is subject to change without notification.
Hospitech Respiration Ltd. has patents and pending patent applications, trademarks, copyrights,
or other intellectual property rights covering subject matter in this document. The furnishing of this
document does not give you any license to these patents, trademarks, copyrights, or other
intellectual property rights except as expressly provided in any written agreement with Hospitech
Respiration Ltd.
Specifications are subject to change without notice.
Table of Contents
ABBREVIATION LIST
1. BEFORE YOU START
Warning
●Read this manual to become familiar with all safety requirements
and operating procedures before attempting to operate the system.
●The AG100s system may only be serviced by Hospitech
Respiration Ltd. authorized personnel.
1.1 Conventions Used in this Manual
The following conventions in the form of notes, cautions and warnings are used
in this manual:
Note
The content of this Note offers general information that is important to
keep in mind.
Caution
ACaution alerts the operator to the possibility of a problem with the
device associated with its use or misuse. Such problems include system
malfunction, failure, and damage to the system or other property. The
caution presents a precautionary action that should be taken to avoid the
potential hazard.
Warning
AWarning alerts the operator to the possibility of injury, death, or serious
adverse reactions associated with the use or misuse of the system.
In many places throughout this manual you will see words or phrases in the text
which are bolded in a sans-serif typeface, such as this. These are words and
phrases that appear on the touch panel display of the system’s control unit. In
addition, references to figures also appear as such throughout this manual.
1.2 Labels and Symbols
The following symbols appear on the AG100s system labels (control unit and
AG connection kit):
AG100s Main Label
AG Connection Kit Label
Symbol Description
Consult Operating Instructions
Serial number
Catalogue number
LOT number
Date of manufacture
Manufacturer
Protection From Electrical Shock
CE Compliance Symbol
MM/YYYY
Discard Product After Expiration Date
Product was Sterilized by Ethylene Oxide Process
Symbol Description
Not for general waste
Single Use Only
Authorized Representative in the European Union
MR Unsafe
1.3 Safety Considerations
The AG100s system was designed to maximize safety for both patients and
personnel. The following are some of the system's preventive safety measures:
1.3.1 Software Safety Features
● Once the system is turned on, the software automatically checks all
safety-related hardware features.
● A watchdog cycle continuously monitors the safe functioning of the
system during operation.
● If an error occurs, the system displays an error message.
1.3.2 System Electrical Grounding
The system is grounded through both the grounding conductor in the
power cable and the internal grounding pin.
1.3.3 Fuse Protection
The system is protected by a surge protection fuse.
1.4 Intended Use Patient Population
1.5 General Precautions
The following precautions must be observed to ensure safe use of the AG100s
system.
● Read this manual thoroughly before attempting to operate the system.
● Do not attempt to service the AG100s system. Only authorized service
personnel may do so. This includes making internal adjustments and
replacing backup battery.
● Only perform maintenance when the system is shut down and disconnected
from the electrical power source. Performing maintenance procedures with
the system powered-up can be hazardous to the operator and/or destructive
to the system.
● Isolation means provided by disconnecting power cord from the mains
● Never leave the system turned on, open or unattended during system
maintenance.
● Always turn o the system when it is not in use.
● Never allow untrained personnel to operate the system.
● The AG connection kit is for single patient, do not reuse.
● Do not use an opened or damaged AG connection kit.
● Use ONLY disposable AG connection kit with the AG100s control unit.
● The AG connection kit is a disposable device for single use only. Reuse of
the AG connection kit can cause harm to the patient and may result in
improper function.
1.6 High Voltage Hazards
Warning
The system utilizes high-voltage electricity. To avoid injury to
personnel, do not operate the system before ensuring that the
exterior panels are properly closed. Do not attempt to remove or
disassemble the exterior panels.
1.7 MR Unsafe
Warning
The system was not tested in MRI environment and thus is
considered as MRI unsafe. Do not operate the system in MRI
environment.
2 PRODUCT OVERVIEW
2.1 Introduction
The AG100s system is designed to provide cu pressure control to all cuffed
airways, and provide suction/evacuation of subglottic secretions from above the
cuff, to all cuffed airways with a suction port. It also offers controlled suction
capability for general use, e.g. oral and lung suction.
While connected to standard cued airways, the system provides:
• Fixed cu pressure as preset by the user
While connected to cued airways with a suction port, the system
provides:
• Fixed cu pressure as preset by the user
• Timely or on demand suction of subglottic secretions from above the cu
While connected to the multi lumens AnapnoGuard Airway, the system
provides:
• Continuous determination and control of the cu pressure based on readings
of Carbon Dioxide (CO2) leaks around the airway cuff
• Timely or on demand suction, or simultaneous rinsing and suction of
subglottic volume
2.2 Description
The AG100s system consists of a Control Unit and a disposable, single use
connection kit (AG Connection Kit). The Control unit can be mounted on a
dedicated cart on the bed side or mounted on the ICU integrated rack (Boom).
• While connected to the AnapnoGuard airway, the system provides precise
and objective measurements of Carbon Dioxide (CO2) above the cu to
determine the minimal cu pressure required for sealing the trachea.
The existence of a high level of CO2 above the airway's cuff (relative to the
room level) is used as an indicator for leaks. The system uses the
measurement of leaks around the cu to determine the lowest pressure
required for sealing the trachea, in closed loop control.
With this airway, the system also provides controlled and effective
evacuation of subglottic secretions from above the cu and controlled
rinsing of the subglottic volume with saline solution, simultaneously with the
suction operation.
• While connected to any suction tube, the system maintains cu pressure as
preset by the user and timely or on demand suction of subglottic secretions
from above the cu.
• While connected to any standard tube, the system maintains cu pressure
control as preset by the user.
• The system is also equipped with an extra, general suction line which
provides general suction at pre-set levels, to be used for general evacuation
of fluids (such as Deep/lung suction or oral suction).
• System parameters and activity all along the intubation are archived in a
patient log file and can be looked at off-line post disconnection
2.3 Device Users
The Intended user population for the AG100s System includes medical
professional staffs (physicians, nurses and respiratory technicians) which treat
mechanically ventilated patients.
2.4 Indications for Use
The AG100s Respiratory Guard System offers airway management by
oral/nasal intubation, while providing continuous endotracheal cu pressure
control, using non-invasive measurement and monitoring of carbon dioxide
concentration in the subglottic space, and evacuation of secretions from above
the endotracheal tube's cu.
2.5 Contra-indications
• The AG100s system should not be used with infants.
• Use of the AnapnoGuard endotracheal tube in procedures using a laser or
an electrosurgical active electrode in the immediate area of the device, is
contra-indicated.
• Contact between the beam or electrode and the tracheal tubes, especially in
the presence of oxygen-enriched or nitrous oxide-containing mixtures, can
cause rapid combustion of the tube with harmful thermal eects and
emission of corrosive and toxic combustion products including hydrochloric
acid (HCl).
3 AG100SSYSTEM COMPONENTS
The AG100s system (figure 3.1) is comprised of the following two main
components:
• The AG100s Control Unit
• The AG connection kit comprised of Cassette and harness line tubes, for
connecting the EndoTracheal tube and other Accessories to the AG100s
control unit.
Additional components:
●Cart (see Section 3.3.1)
●Power cord (see Section 3.3.2)
●Vacuum inlet connector (see Section 3.3.3)
●Air lter (see Section 3.3.4)
●Canister (see Section 3.3.5)
●Saline bag (see Section 3.3.6)
Figure 3-1: AG100s Component Overview
3.1 Control Unit Components
The control unit (gure 3.2) is comprised of the following components:
● Power supply
● UPS - backup battery
● Power distributor module
● Host computer (PC)
● Electronic boards
● Suction module - to provide evacuation force to suction and vent lines
● Venting module - air pump with filter to ventilate the area above the cu
● Rinsing module - peristaltic pump that pumps saline to rinse the suction and
CO2venting lumens
● CO2analyzer module - including CO2 analyzer assembly and valves
● Cu pressure module - includes two pressure gauges which monitor cuff
pressure, a miniature air pump and two valves
● Connection panel - for connecting the cassette to the control system.
● Piano valve – a mechanical valve used to configure the cassette routing of
operational procedure.
● Operation buttons – Power On/O and Stand By
Figure 3-2: AG100s Control Unit
3.2 The AG connection kit
The AG Connection Kit (gure 3.3) is designed to connect the AG100s control
unit with the patient’s Endotracheal tube (ETT) and with the exterior accessory
units (canister and saline bag) required for system operation.
Warning
The ETT is a disposable tube, meant for single use only. Do not reuse.
Warning
The outside diameter (OD) of the AnapnoGuard ETT and suction ETT is
on average 0.8-1.0 mm greater in diameter then a standard ETT. This is a
result of the extra suction line and vent line (for AnapnoGuard ETT)
incorporated into the tube design. One should consider choosing an
AnapnoGuard or suction ETT one half size smaller than “usual” if there is
anticipation that the larger OD will be a concern.
The AG connection kit is comprised of an interface module with the AG100s
control unit, encapsulating a cassette comprised of an extension harness of six
PVC line tubes with color coded connectors (table 1); the suction line (yellow),
vent line (green) and cu inate line (clear) are connected to the ETT (when
applicable). The general suction line (orange) is used for low/high suction with
the patient’s cavity or the ETT’s main lumen. The two wide diameter lines are
connected to the secretions canister for vacuum (white connector) and patient
(blue connector).
Table 1: AG connection kit Units
Part Part description Connector color
a Cassette NA
b Rinse (saline) Tube with a Check Valve Clear
c Suction Line Yellow
d Vent Line Green
e Cu Inflation Line Clear
f General Suction Line Orange
g Canister Patient Line Blue
h Canister Vacuum Line White
i Antibacterial filter NA
The AG connection kit is supplied sterile (ETO sterilization) and is intended for
single patient use only.
Note
The AG connection kit is supplied with an accompanying document.
3.3 Additional Components
3.3.1 Cart
The AG100s control unit is secured to the cart by leading rails mounted on
the bottom of the AG100s control unit. The cart includes a bar for the
saline bag and holder for the Canister. The cart wheels include brakes to
prevent accidental movement.
3.3.2 Power Cord
A power cord is supplied with the AG100s control unit. The rating of the
power cord is 10A/250Vac.
Figure 3-3: AG connection kit
3.3.3 Vacuum Inlet Connector
A designated vacuum inlet connector (gure 3-4) is supplied with the
AG100s control unit. It is compatible with a ¼’’ ID tube which connects to
the hospital’s vacuum source.
3.3.4 Air Filter
A sterilized antibacterial hydrophobic air filter (gure 3-5) is supplied with
the AG100s control unit and is situated on its back panel.
3.3.5 Canister
A standard, disposable, single-use secretion canister (up to 1 liter) is
located on the lower part of the cart to collect subglottic secretions for easy
disposal or analysis (figure 3-6). The canister needs to be replaced on a
timely schedule, or when its level becomes high.
Figure 3-4: Vacuum
inlet connector
Figure 3-5: Air filter
Figure 3-6: Canister
Warning
The canister is a consumable meant for single use only. Do no reuse.
Note
Canisters are acquired separately and not included with the AG100s
system.
3.3.6 Saline Bag
When the AG100s system is used in conjunction with the AnapnoGuard
Endo-tracheal tube (AG ETT) standard saline solution (0.9% NaCl
concentration) is used for subglottic rinsing via the Vent line, while suction
is performed via the Suction line. The rinsed saline and secretions
suctioned from the subglottic space above the cu are evacuated into the
suction canister. The Saline solution bag needs to be replaced on a timely
schedule, or when its level becomes low.
Note
Saline bags are acquired separately, and not included with the AG100s
system.
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