Operation Manual
Neonatal Pulmonary Ventilator
The names and logotypes Intermed® and inter® are trademarks of Intermed
Equipamento Médico Hospitalar Ltda.
São Paulo - Brazil - © 2011
MOP Code 806.00260
2 - Foreword
Operation Manual
!
CAUTION:
Read this manual completely before using Inter NEO on patients.
This equipment and its documents can be changed without any
previous notice to the user.
Skip the steps related to a heated humidifier if it is not being used.
Check the respective instructions when working with other
instruments.
INTERMED®
®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Foreword - 3
Foreword
This Operation Manual provides the necessary information for
the correct use of the neonatal lung ventilator Inter® NEO,
Intermed® brand.
Manufacturer:
Intermed Equipamento Médico Hospitalar Ltda.
Rua Santa Mônica, 980 - Cotia - SP - Brazil - CEP 06715-865
Telephone: +55 (11) 5670 1300 - +55 (11) 4615 9300
Fax: +55 (11) 4615 9310
website: www.intermed.com.br
E-mail: contato@intermed.com.br
CNPJ: 49.520.521/0001-69 - I.E.: 278.188.774.118
After Sales:
0800 770 3357, +55 (11) 5670 1300 or by site.
ANVISA Product Registration:
Technical name: Lung Ventilator Pressure and Volume
Business Name: Neonatal Lung Ventilator Inter® NEO
ANVISA Registration No: 10243240044
Product Classification:
NBR IEC 60601-1:1994 and 1997 amendment;
NBR IEC 60601-1-2:2006; NBR IEC 60601-2-12:2004;
EN 60601-1:1990/A1:1993/A2:1995; EN 60601-1-2:2001/
A1:2004; EN 60601-2-12:2006.
93/42:2003/EEC - Medical Device - IIb rule 9
Equipment Class I/Internally Powered
Type B applied part - IP24 - Constant Operation
Equipment not appropriate for utilization in the presence of a
anesthetic mixture inflammable with air, oxygen or nitrous
oxide.
OBELIS s.a.
Boulevard Général Wahis 53
1030 Brussels, BELGIUM
Tel: +(32) 2.732.59.54
E-Mail: mail@obelis.net
Technical responsible:
Eng. Jorge Bonassa
CREA 137.189/D
INTERMED®
Inter® NEO
Fax: +(32) 2.732.60.03
Legal responsible:
Milton Rubens Salles
Operation Manual code 806.00260 Rev. 07
4 - Foreword
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Table of Contents - 5
Table of Contents
Chapter 1: Introduction .................................................. . 09
Description ......................................................................... 10
Chapter 2: Precautions and Notes ................................... 11
Chapter 3: Controls, Monitors, Indicators and Alarms ... 17
Front Panel ...................................................................... . 18
Controls ............................................................................. 19
Mode A/C ........................................................................... 19
SIMV/CPAP Mode ............................................................... 21
SENSITIVITY L/min / hPa .................................................... 21
INSP. TIME s....................................................................... 22
FLOW L/min ....................................................................... 22
RESP RATE min-1 .................................................................................................................... . 22
PEEP hPa (cmH O) ............................................................. 22
P LIMIT hPa (cmH O) .......................................................... 23
P Support hPa (cmH O) ....................................................... 23
MANUAL CYCLE ................................................................. 24
NEBULIZER / TGI ................................................................ 24
INSP HOLD ......................................................................... 24
EXP HOLD .......................................................................... 25
SILENCE/RESET ................................................................ 25
Alarms............................................................................... 26
Low Press hPa (cmH O) .................................................... . 26
High PEEP ........................................................................ . 26
High Press hPa (cmH O) ..................................................... 27
Low Minute Volume L ......................................................... . 27
Apnea s (back up) ............................................................... 28
Vent Inop ............................................................................ 28
Gas Fail ............................................................................ . 29
Power Fail ........................................................................... 29
Visual Indicators ................................................................ 29
Power ................................................................................. 29
AC Line .............................................................................. 29
DC Line .............................................................................. 30
Int Batt ................................................................................ 30
Batt Charge ......................................................................... 30
2
2
2
2
2
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
6 - Table of Contents
Peak Pressure - Gauge ..................................................... . 31
Effort .................................................................................. 31
Monitors .......................................................................... . 32
I:E Ratio ............................................................................ . 32
Tidal Vol - Resp Rate/ Minute Vol - MAP ............................. . 32
Electronic Gauge................................................................. 33
Hour Meter ................................................................................. 34
Other Controls ................................................................ . 34
Blender ............................................................................... 34
Rear Panel ......................................................................... 35
Rear panel configuration ................................................... 35
AC Power Input ................................................................... 35
Power Switch .................................................................... . 35
DC Power ........................................................................... 36
RS 232.............................................................................. . 37
Alarm Loudness ................................................................ . 37
Inflating Gas Input ............................................................... 37
Oxygen Cell Input .............................................................. . 38
Side Panel .......................................................................... 38
Exhalation valve connection ............................................... . 39
Proximal Line .................................................................... . 40
Nebulizer / TGI .................................................................... 40
Flow Sensor - Flow sensor connection ................................. 41
O SENSOR - Sensor for O analysis ..................................... 42
2
2
Chapter 4: Assembly ......................................................... 43
Circuit Assembly ............................................................... . 45
Diaphragm Positioning ...................................................... . 46
Exhalation valve connection ................................................. 46
Neonatal / Pediatric Patient Circuit and Flow Sensor ....... 47/48
Chapter 5: Operation ........................................................ 49
Introduction ......................................................................... 50
A/C Mode .......................................................................... . 51
SIMV/CPAP Mode ............................................................... 52
Chapter 6: Troubleshooting ............................................ . 53
Chapter 7: Cleaning and Sterilization ............................. . 59
Ventilator and Monitor ........................................................ . 60
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Table of Contents - 7
Cooling air inlet filter .......................................................... . 61
Recommended cleaning processes .................................... . 62
Washing ........................................................................... . 63
Chemical Disinfection by Immersion .................................. . 63
Chemical Sterilization by Immersion ................................... . 63
Autoclave .......................................................................... . 64
ETO - Ethylene Oxide (C2H4O) ............................................. 64
Chapter 8: Accessories, Components and Parts ........... . 65
Chapter 9: Preventive Maintenance ............................. . 69
Functional Verification Test - FVT ..................................... 70
Regular Preventive Maintenance .................................. . 71
Internal batteries ............................................................ . 72
Sealed acid-lead type battery ............................................ . 72
Lithium Battery .................................................................. . 72
Internal Batteries Replacement............................................. 73
Disposal of Internal Battery and other materials .................... 73
Annual Preventive Maintenance - APM ............................. 74
Chapter 10: Technical Description .................................... 75
Classification ..................................................................... . 76
Controls ............................................................................ . 77
Monitors ............................................................................ . 78
Indicators .......................................................................... . 78
Alarms .............................................................................. . 79
Flow Sensors .................................................................... . 80
Concentration Sensor .......................................................... 81
Patient’s Circuit ................................................................. . 82
Power Supply .................................................................... . 83
Pneumatic Inlet ................................................................. . 83
Blender (Air/O2 Mixer) ......................................................... 83
Misty 3 Intermed® Humidifier ................................................ 84
IM300® Intermed® Jar ........................................................ . 84
Physical Characteristics ...................................................... 85
Environmental Specifications ............................................. . 85
Electromagnetic immunity .................................................. . 86
Chapter 11: Warranty...................................................... . 91
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
8 - Table of Contents
Attachment A: Initial Check List ........................................ 93
Attachment B: Symbols and Terminology ........................ 95
Attachment C: Pneumatic Diagram................................. . 99
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 1: Introduction - 9
Chapter 1: Introduction
!
Always use
the Operation
Manual as
reference.
In this Chapter:
!
INTERMED®
Description
Inter® NEO
Operation Manual code 806.00260 Rev. 07
10 - Chapter 1: Introduction
Description
Inter NEO is an electronic, microprocessor-driven ventilator that
incorporates the most up-to-date features of mechanical ventilation
for neonatal and pediatric patients under intensive therapy.
®
The digital flow valve with response time shorter than 10 ms
enables programming the respiratory rate up to 180 min-1.
The Double Exhalation Valve system enables an accurate and safe
pressure control in all types of patients. The joint operation of the
exhalation and flow valves enables patient exhalation during the
inspiratory phase of cycles with controlled pressure, thus reducing
the need of sedatives.
The Tracheal Gas Insufflation feature, synchronized with the
expiratory phase, is useful in handling patients with acute
respiratory failure.
The Inter® GMX graphical monitor enables to verify the curves,
parameters, loops, ventilation trends and to display the alarm
messages on the graphical monitor screen.
Besides volume monitoring, the neonatal and pediatric flow sensors
specially designed and calibrated for each application range are
used to detect the patient’s inspiratory effort through the flow, which
enables synchronizing the patient breathing from 600 grams.
The equipment performs an self calibration and cleaning routine
eliminating eventual existing liquids in the sensor measuring duct,
both in the inspiratory and expiratory branch, and readjusts the zero
flow with regards to the transducer natural variation.
The Inter NEO was designed in fully compliance with the Brazilian
and international guidelines regarding electromedical equipment.
®
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 2: Precautions and Notes - 11
Chapter 2: Precautions and Notes
!
In this Chapter:
! Caution
! Warning
! Notes
Inter® NEO must be handled and operated by qualified and trained
personnel under the direct supervision of a licentiate physician.
You must READ THE OPERATION MANUAL COMPLETELY,
BEFORE using the Inter® NEO on patients.
The use of this equipment before its characteristics and functions
are fully understood may result in risk conditions for the operator, the
patient and even the equipment it self.
All paragraphs preceded by the following terms deserve special
attention:
CAUTION: Indicates those conditions that may adversely affect
the operator or the patient.
!
WARNING: Indicates those conditions that may affect or damage
the equipment or its accessories.
NOTE: Indicates additional information for a better understanding
of the equipment functioning.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
12 - Chapter 2: Precautions and Notes
!
CAUTION:
! CLEAN the ventilator before the first use session and after
using the equipment on each patient (or more frequently, if
needed). DISASSEMBLE and STERILIZE the accessories,
according to Chapter 7.
! Always use MEDICAL GRADE gas (dry and free from
contaminants) to prevent internal damages to the ventilator and
risks to the patient.
! EXPLOSION HAZARD: NEVER USE the ventilator in the
presence of inflammable anesthetic gases.
! Electrical shock hazard: NEVER DISASSEMBLE THE
VENTILATOR CABINET. Contact Intermed® in case of any
problem or difficulty at 0800 770 3357.
! Do not use antistatic or electrically conductive hoses and/or
pipes with the ventilator.
! Use patient circuit and tubes manufactured by Intermed® that
comply with the cytotoxicity, irritation, sensitivity and
hemocompatibility requirements.
! The ventilator must be always CONNECTED to a power mains
with a PROTECTION GROUNDING SYSTEM and outlet
compatible with the equipment’s power plug. NEVER MAKE
INEFFECTIVE THE PLUG GROUNDING TERMINAL. Only use
the cable supplied with the ventilator and make sure that it is in
good operating conditions.
! In case of doubt about the GROUNDING SYSTEM INTEGRITY,
manage the equipment with its internal battery or any other
external battery.
! This equipment functioning may be ADVERSELY AFFECTED
by operating, close to it, other equipment such as HIGH
FREQUENCY surgical apparatus, SHORT WAVES therapy
equipment or others that exceeds the emission limits specified
on NBR IEC 60601-1-2:2006 standard.
! Do not work with the equipment BEFORE adjusting its alarms.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 2: Precautions and Notes - 13
!
CAUTION:
! Check the audible and visible alarms on a daily basis, to ensure
that they are responding properly.
! In case the ventilator is not equipped with the Inter® GMX Slim
monitor, a duly calibrated oxygen analyzer should be used to
ensure that the O2 adjusted values will be supplied to the patient.
! Always use Intermed® ORIGINAL ACCESSORIES,
COMPONENTS AND PARTS to ensure equipment
performance, patient and/or user safety and warranty rights.
! When adding accessories or other components to the
respiratory system, the operator must ensure that the inspiratory
and expiratory resistances, measured at the patient connection
during the spontaneous breathing and normal operation do not
exceed 6 hPa (cmH2O) for 30 L/min in pediatric use and 6 hPa
(cmH2O) for 6 L/min in neonatal use.
! ALWAYS USE the ventilator IN COMPLIANCE WITH THE
SPECIFICATIONS included in this manual. In case of any doubt,
call Intermed® 0800 770 3357.
! To ensure electrical protection and prevent fire risk, NEVER
replace the fuses. Contact Intermed® at 0800 770 3357 in case
the equipment does not work. An incorrect fuse replacement
voids the warranty and can impair the patient / operator safety
and equipment operation.
! The ventilator is a life-supporting equipment. NEVER entrust the
MAINTENANCE of this equipment to UNAUTHORIZED
PERSONNEL. Contact Intermed® at 0800 770 3357 in case of
any problem or difficulty.
! The RS 232 connector located at the rear panel is intended
exclusively to the communication with a PC or equivalent device.
When it is not being used, keep it protected with its respective
cover.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
14 - Chapter 2: Precautions and Notes
!
CAUTION:
! Keep the control protection cover always closed to assure that
the adjusted parameters are preserved.
! When the ventilator is connected on patients, a QUALIFIED
PROFESSIONAL must be ON THE ALERT to take the
necessary actions in the occurrence of alarms or problems. An
ALARM indicates a situation that requires operator attention
and SHALL NEVER BE IGNORED.
! An alternative ventilation system (ex. manual resuscitator) must
be available whenever the ventilator is being used.
! Provide the cleaning of eventual solid residuals in the flow
sensor measuring duct to avoid affecting the sensor accuracy.
! After locating the equipment for starting operation, lock the
pedestal casters.
! Perform the Functional Verification Test (FVT) described in
Chapter 9 - Preventive Maintenance - before using the
equipment on patients or whenever doubts about the ventilator
operation arise. If any problems are detected during the FVT,
stop using the equipment and ask for a maintenance
attendance.
! All parts and components replaced during the maintenance
processes should be discarded as determined by the local
legislation where the equipment is installed. Special attention
must be given to the internal lead-acid battery that should follow
its manufacturer’s guidelines, described in the side part of the
product.
!
WARNING:
! NEVER STERILIZE THE VENTILATOR. The internal
components are not compatible with sterilization techniques.
! Follow the equipment cleaning and accessory sterilization
instructions, according to Chapter 7 of this manual.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 2: Precautions and Notes - 15
!
WARNING:
! STERILIZING AGENTS CONTAINING phenol, ammonium
chloride, dimethyl and solutions with a glutaraldehyde
concentration greater than 2% CAN DAMAGE the plastic
components.
! The GAS INLET FILTER (AIR AND OXYGEN) located in the rear
panel must be CHECKED BEFORE EACH USE SESSION or
DURING THE USE SESSION, on a periodical basis. Remove
the condensed water at the filter bowl, in order to prevent it from
entering the equipment and impairing its operation.
! THE MAINTENANCE of Inter® NEO must be performed only by
Intermed® Technical Assistance Service.
! The equipment has safety SEALS in the closing screws.
Breaking these seals by non-authorized personnel may void the
equipment WARRANTY.
! NEVER operate the equipment directly exposed to sunlight and
heat.
! NEVER cover or locate the ventilator so as to obstruct the
cooling air inlet.
! Inter® NEO is an equipment that does not generate Negative
Expiratory Pressure.
!
NOTES:
! The circuit diagrams, component lists, technical descriptions,
setting & calibration instructions and other necessary information
for the equipment maintenance can be supplied to the customer
upon request.
! The ventilator is a medical equipment and must be handled and
operated by qualified and trained personnel under the direct
supervision of a physician.
! During the Cleaning and Auto Zero performance period (25
seconds) there is an interval in the monitoring.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
16 - Chapter 2: Precautions and Notes
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 17
Chapter 3: Controls, Monitors,
Indicators and Alarms
!
It is important
to be acquainted
with all the
Inter® NEO
controls.
In this Chapter:
!
!
!
!
!
!
!
!
INTERMED®
Front Panel
Controls
Alarms
Visual Indicators
Monitors
Analog Displays
Other Controls
Rear Panel
Inter® NEO
Operation Manual code 806.00260 Rev. 07
18 - Chapter 3: Controls, Monitors, Indicators and Alarms
Front Panel
Figure 3.1- Front Panel of Inter® NEO
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 19
Controls
This key selects the ventilating modes provided by
the equipment:
" A/C (Controlled Assisted)
" SIMV / CPAP (Synchronized and Intermittent
Mandatory Ventilation / Constant Positive Pressure in
the Airways)
The ventilator provides the following respiratory cycles, depending
on the selected ventilation mode:
Mode
Controlled
Assisted
A/C
x
x
SIMV
x
x
CPAP
Spontaneous
x
x
Controlled cycle: It is started by the ventilator in relation to the
programmed respiratory rate or in the occurrence of an apnea
period that activates the backup system (controlled cycle initiated
by ventilator after apnea adjusted time elapsed).
Assisted cycle: It is started by the patient and follows the same
adjusted parameters as the controlled cycles.
Spontaneous cycle: It is started by the patient. The flow, volume
and time values depend on the flow, the adjusted expiratory
pressure, the breathing mechanics and the patient’s inspiratory
effort level.
AC Mode - Assisted / Controlled
In this mode, the ventilator enables the controlled and assisted
time-cycled ventilation cycles, with limited pressure and continous
flow.
The following parameters must be adjusted:
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
20 - Chapter 3: Controls, Monitors, Indicators and Alarms
PARAMETER
CONTROL
UNIT
Inspiratory Time
INSP TIME
s
Respiratory Rate
RESP RATE
min-1
Inspiratory Flow
FLOW
L/min
Inspiratory Pressure
P LIMIT
hPa (cmH2O)
Expiratory Pressure
PEEP
hPa (cmH2O)
Assisted Sensitivity
SENSITIVITY
L/min
PARAMETER
CONTROL
UNIT
A/C Mode
Inspiratory Pause
Insp Pause
s
Optional
settings
Nebulization
Nebulizer
Tracheal Gas Insufflation
TGI
Apnea Time - Back up
Apnea (Back up)
A/C Mode Mandatory
settings
s
Interdependent
Controls
Limiting
Conditions
Ratio
Inspiratory Time
I:E Ratio > 3:1*
Insp. T. + Exp. T. = Tcycle
Respiratory Rate (s)
T. Exp < 0,3s
Tcycle = 60s/Resp.Rate (1/s)
A/C Mode
Interdependence
in modality:
I:E = 1:Insp T. / Exp T.
* For respiratory rates above 15min-1.
The ventilator will maintain the continuous flow (inspiratory and
expiratory phase) at the adjusted value in the flow control (FLOW).
During the expiratory phase, the ventilator will keep the exhalation
valve in the adjusted PEEP value; likewise, it will close the
exhalation valve during the inspiratory phase, thus limiting the
pressure at the P LIMIT adjusted value.
In this mode, the airway pressure is simply limited and not
controlled. Depending on the inspiratory flow (FLOW) and
Inspiratory Time (INSP TIME) adjusted values, and the patient’s
breathing mechanics, the airway pressure may not reach the
intended Inspiratory pressure value.
Both the expiratory and inspiratory flows remain constant in their
adjusted values. An intense inspiratory effort by the patient may
cause a decrease in the airway pressure in case of insufficient flow.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 21
!
NOTE:
The manual inspiratory pause activation (HOLD) through the
constant pressing of the control button will extend the pause for a
period of up to 15 seconds.
SIMV/CPAP Mode
Synchronized Intermittent and Mandatory Ventilation /
Constant Positive Airway Pressure.
In this mode, the ventilator enables the spontaneous cycles along
with the controlled and assisted cycles. The flow (FLOW) must be
adjusted in order to meet the patient inspiratory demand. The same
parameters as the mode A/C must be adjusted in this case.
SENSITIVITY L/min / hPa
Sensitivity
The ! and " keys determine the patient inspiratory effort level
required for the ventilator to start the assisted cycles, according to
the adjusted parameters.
The Inter® NEO enables the sensitivity adjustment by flow. The
inspiratory effort will be detected when the patient inspired flow
reaches the programmed value at the sensitivity setting.
During the self-calibration and cleaning process, or if the flow
sensor is disconnected, the ventilator will only trigger cycles by
pressure (in hPa), remaining the respective green led lit. The
adjustment of the sensitivity level in hPa is only available during the
self-calibration process or while the sensor is disconnected from
the ventilator.
The visual indicator (led) Effort (Respiratory Effort) is activated
whenever the patient’s effort reaches the adjusted sensitivity level.
The Sensitivity control may be disabled by pressuring the " key
until two traces appear on the display (- -).
SCALE:
Neonatal sensor: 0.2 to 2 L/min; Disabled ( - - )
Pediatric sensor: 0.5 to 5 L/min; Disabled ( - - )
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
22 - Chapter 3: Controls, Monitors, Indicators and Alarms
INSP. TIME s
Inspiratory Time
This control enables inspiratory time adjustment (INSP TIME).
SCALE: 0.10 to 15s
FLOW L/min
Flow
This control enables the continuous flow adjustment during the
inspiratory and expiratory phases.
FLOW SCALE: 2 to 30 L/min
RESP RATE min-1
Respiratory Rate
This control determines:
" The minimum rate of controlled and/or assisted cycles provided
by the ventilator during the assisted/controlled (A/C) mode.
" The total frequency of controlled and assisted cycles during the
SIMV mode.
The zero rate programming enables the CPAP modality in the
SIMV/CPAP modes.
SCALE: 0 to 180 min-1
PEEP hPa (cmH2O)
Final Expiratory Positive Pressure
This control determines the pressure level during the expiratory
phase or the airway constant pressure in the CPAP mode.
SCALE: 0 to 50 hPa (cmH O)
2
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 23
!
NOTE:
The equipment does not allow the sub atmospheric expiratory
pressure values setting (NEEP - Negative End Expiratory
Pressure).
P LIMIT hPa (cmH2O)
Pressure Limit
This control determines the inspiratory pressure limit setting (P
LIMIT).
SCALE: 5 to 70 hPa (cmH O) or with the same minimum value of
the adjusted PEEP.
2
P Support hPa (cmH2O)
Pressure Support
This control determines the pressure support level (P Support).
The pressure support is a method to reduce the respiratory work of
the patient during spontaneous breathing. In the course of
spontaneous cycles in SIMV or CPAP modes, after setting a
pressure support level above of the PEEP, the ventilator will raise
the pressure in the airway up to the pressure support adjusted
value, in a synchronized manner with the patient effort.
This raising in the airway pressure will increase the inspiratory flow
and consequently the volume.
The pressure support will be disabled concluding the inspiratory
phase when any of the following occur:
- The inspiratory flow decreases to a value equal to 25% of the
flow peak obtained at the beginning of the inspiratory phase;
- The inspiratory time reaches the adjusted value in the INSP
TIME control: this is a safety mechanism to enable the conclusion
of the cycle with pressure support even with leakages.
The inspiratory flow during spontaneous cycles with pressure
support may exceed the adjusted value in the INSP FLOW control.
SCALE: 0 to 50 hPa (cmH O) or with the same minimum value of
the adjusted PEEP and the same maximum value of the P LIMIT.
MANUAL CYCLE
2
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
24 - Chapter 3: Controls, Monitors, Indicators and Alarms
Manual Cycle
This key starts a controlled cycle in the selected mode. The
ventilator will skip this command if the key is pressed during the
inspiratory phase or during the 300-ms initial period of the
expiratory phase. The manual cycle occurrence is indicated by the
respective led.
NEBULIZER / TGI - Tracheal Gas Nebulization/Insufflation
By pressing this key, the ventilator will alternate at the following
options:
1. Nebulizer:
- A/C Mode (Nebulizer led lighted):
The ventilator releases a flow of 6 L/min synchronized with the
inspiratory phase at the Nebulizer/TGI outlet.
- SIMV/CPAP Mode (Nebulizer and TGI led lighted):
The ventilator releases a continuous flow of 6 L/min, in both phases,
at the Nebulizer/TGI outlet.
At the two modes, this flow must be connected to a nebulizer
located at the inspiratory branch of patient’s circuit.
2. TGI - Tracheal Gas Insufflation (TGI led lighted):
The ventilator releases a flow of 6L/min synchronized with the
expiratory phase at the Nebulizer/TGI outlet.
This flow must be connected to a catheter located at the carina of
the patient to perform the “washing” of CO retained at the airways
during exhalation.
3. Off
2
INSP HOLD
Manual Inspiratory Pause
This key enables the manual inspiratory pause when pressed for
more than 3 seconds. The ventilator will keep the inspiratory pause
while the key is activated for up to 15 seconds.
The key can be pressed anytime and the pause will only be
activated when the inspiratory time of the next controlled or assisted
cycle ends. To facilitate pause detection, the indicator led keeps
blinking from the moment the key is pressed to the start of the
pause, and remains lit during the entire pause period. The plateau
pressure reading can be performed at such occasion, using the
ventilator’s gauge or the graphical monitor.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 25
During the inspiratory pause and without any flow, the equalization
between the alveolar pressure and airway pressure occurs,
monitored in the manometer. Therefore, the alveolar pressure value
can then be checked during the inspiratory pause, directly on the
ventilator’s gauge, at the end of the inspiration period (lung elastic
pressure or plateau pressure).
EXP HOLD
Expiratory Pause
This key enables the performance of the manual expiratory pause.
The pause will be maintained while the key is pressed for up to 15
seconds. The key can be pressed anytime and the pause will only
be activated when the expiratory time ends.
In order to facilitate pause detection, the indicator led keeps
blinking from the moment the key is pressed to the start of pause,
and remains lit during the entire pause period.
At this point, the expiratory pause pressure can be read on the
ventilator’s gauge or the graphical monitor.
During the expiratory pause and without any flow, the equalization
between the alveolar pressure and airway pressure occurs,
monitored on the gauge. Therefore, the alveolar pressure value can
then be checked during the expiratory pause, directly on the
ventilator’s gauge, at the end of the exhalation period.
If the pressure value measured during the expiratory pause is above
the adjusted PEEP expiratory pressure, the auto PEEP occurrence
is verified (hidden PEEP or intrinsic PEEP).
Silence/Reset
This key silences the audible alarm for 60 seconds; the alarm can
be reactivated if the key is pressed again within this period. The
activation of a yellow led light indicates the existence of a silenced
alarm.
This key also acts as a Reset, turning off the alarm visual indicators
after the generating condition no longer exists.
!
NOTE:
The Silence key does not prevent the alarm activation on the
occurrence of another alarm triggering condition.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
26 - Chapter 3: Controls, Monitors, Indicators and Alarms
ALARMS
The Inter® NEO provides medium and high priority alarms
classified according to the urgency required as the operator takes
action.
Medium priority alarm: requires a response without delay. Its
visual indication is an intermittent yellow led with a 3 bip loudness
every 25s.
High priority alarm: requires an immediate response. Its visual
indication is an intermittent red led with 5 bips loudness every 10s.
Low Press hPa (cmH2O)
Low Inspiratory Pressure
The keys ! and " of the Low Press alarm enable adjusting the
minimum pressure value in the airways during the inspiratory phase
of the controlled and/or assisted cycles. If the minimum preset value
is not reached, the equipment will trigger an audible alarm and the
Low Press visual indication in red (high priority).
The low inspiratory pressure alarm enables detecting circuit
disconnection, leakage occurrences or even changes in the
patient’s breathing mechanics.
SCALE: 3 to 70 hPa (cmH O)
2
High PEEP
Constant High Pressure in the Airway
The High PEEP alarm is triggered whenever the pressure in the
airway (PEEP) remains above the value adjusted during the
expiratory phase. The audible and visual alarm in red (high priority)
will be triggered and the respiratory circuit will be depressurized.
Under such conditions, the ventilator fully opens the exhalation valve
at the expiratory branch, the exhalation valve at the inspiratory
branch and the sub-environment valve (the last two within the
ventilator) during 5 seconds. Normal operation is reestablished
after such period.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 27
This alarm is automatically determined by the ventilator and varies
according to the frequency:
Frequency
Alarm activation High Peep
Up to 120 cycles/min
10 hPa (cmH2O) above the adjusted PEEP
From 120 to 180 cycles/min
15 hPa (cmH2O) above the adjusted PEEP
The above values are valid for the following conditions:
The alarm will occur after 3 consecutive cycles in the < 2s expiratory
time.
The alarm will occur after 2 consecutive cycles from 2 to< 5s
expiratory time.
In the 5 or more seconds expiratory time, the alarm will occur if the
pressure rises above the described conditions.
SCALE: 10 to 65 hPa (cmH O)
2
High Press hPa (cmH O)
High Pressure
2
The ! and " keys of the High Press alarm enable to adjust the
maximum pressure limit during the inspiratory phase of the
ventilation cycles.
When the alarm pressure limit is reached during the inspiratory
phase, the ventilator interrupts this phase, cycles to the adjusted
expiratory pressure value (PEEP) and triggers an audible alarm
along with the High Press visual indication in red (high priority).
SCALE: 10 to 80 hPa (cmH O)
2
Low Minute Volume L
Low Minute Volume
The ! and " keys adjust the expiratory minute volume minimum
value upon which the sound and yellow colored (medium priority)
alarm will be activated. The alarm is based on the expiratory minute
volume monitoring through the flow sensor in the patient airway. This
alarm may be disabled by pressing the ! key until two traces
appear on the display.
Values below 0.1L (100 ml) will be displayed on the screen
alternating the indication 0.0 and 5 to 0.05L (50mL).
SCALE: 0.05 to 10L; OFF (- -)
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
28 - Chapter 3: Controls, Monitors, Indicators and Alarms
The Low Minute red (high priority) indicator informs the previous
existance of cycles where no expiratory phase was detected circuit disconection between flow sensor and patient. This alarm
occurs in the following conditions:
3 cycles for Adult and Pediatric sensors
6 cycles for Neonatal sensor
Failure Indicator at the reference flow value:
The activation of the sound/visual alarm Low Minute Volume L
followed by the visual indication AEr on the Tidal Vol L display
indicates a failure at the flow reference value (0 L/min). In this case
stop using the equipment and contact Intermed 0800 770 3357.
®
Apnea s (back up)
Apnea
The ! and " keys of this control establishes the maximum apnea
period allowed.
If the apnea period is reached, the ventilator will start a controlled
cycle according to the adjusted parameters, triggering a momentary
audible alarm and a visual indication in yellow (medium priority).
This alarm may be disabled by pressing the " key until two traces
appear on the display. In this situation, the ventilator will trigger the
audible alarm after 15 seconds without a patient effort, but will not
start any ventilation cycle.
The Apnea control (back up) is a safety ventilation mode, useful
during the SIMV/CPAP modes.
SCALE:
- OFF (15 seconds)
- 1 to 30 seconds
Vent Inop
Inoperative Ventilator
This led (red - high priority) indicates that the ventilator is
inoperative and the electrical and pneumatic controls are inactive.
The inoperative condition is generated in the following cases:
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 29
1. Power Fail power failure;
2. Gas Fail pneumatic supply failure.
3. Electronic failure detected by the ventilator’s safety circuits.
Gas Fail
Gas Failure
This alarm (red led - high priority) indicates the existence of a
failure in the input pressure of the air/oxygen mixture from the
blender, which may be below or above the specified range
(between 300 and 400 kPa).
The alarm will also be triggered when the gas network/source
pressure is < 300kPa or if the ventilator’s internal pressure is
<130kPa, preventing a regular working pressure of 350 kPa.
!
NOTE:
On the occurrence of Vent Inop and Gas Failure, a sub-environment
valve will be activated, allowing the patient to breathe spontaneously
from the environmental air.
Power Fail
Power Failure
This alarm (red led - high priority) indicates power failure arising
from the power supply sources: power outage at the AC or DC
external supply and power outage of the internal battery. Under such
conditions, the ventilator is rendered inoperative and the Vent Inop
alarm is triggered.
VISUAL INDICATORS
Power
The Power visual indicator, in green, lights whenever the equipment
is turned on through the Power (On/Off) switch on the rear panel.
AC Line
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
30 - Chapter 3: Controls, Monitors, Indicators and Alarms
Alternating Current
The AC Line visual indicator, in green, lights whenever the
equipment is connected to the AC power supply.
DC Line
Direct Current
The DC Line visual indicator, in green, lights whenever the
equipment is connected to an alternative power supply of 12 V
direct current and turned on through the POWER (on/off) switch on
the rear panel.
Int Batt
Internal Battery
The Int Batt visual indicator, in yellow, lights whenever the equipment
is disconnected from any of the external power supplies (AC or DC)
and turned on through the Power switch (on/off) on the rear panel.
This led lightning, in yellow, indicates that the equipment is being
powered by its internal battery and if it is blinking in green, the
internal battery is being charged.
!
NOTE:
! If the external supply (AC or DC) is switched to an internal
battery, the equipment will trigger an audible alrm of medium
priority until the Silence/Reset key is pressed, but it will continue
its normal operation. In this case, note the lightning of the Int Batt
(internal battery - in yellow) and Batt Charge (Battery charge)
leds to ensure the adequate charging and provide an alternative
power source.
Batt Charge
Battery Charge
The Batt Charge visual indicator lights whenever the equipment is
turned on by the Power (On/Off) switch on the rear panel, being
supplied by the external source (AC or DC) or the internal battery.
This led should be constantly observed to ensure the adequate
charge if using the battery. The battery charge level is indicated by
the following colors:
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 31
!
COLOR
LEVEL
APPROXIMATE ENDURANCE
GREEN
Full
120 to 60 minutes
ORANGE
Medium
60 to 15 minutes
Intermittent RED
Low
Less than 15 minutes
WARNING:
1. When reaching the low charge condition (maximum endurance of
15 minutes), the Batt Charge led assumes a red color, blinking in an
intermittent form and triggering the audible alarm. Connect the
ventilator to the power mains or to an external DC power supply.
Otherwise, the ventilator will be rendered inoperative, triggering the
Power Fail and Vent Inop alarms.
2. The battery is not recharged with the equipment connected to the
DC network. In such case, for a maximum battery time, connect the
ventilator to the AC power mains for at least 10 hours up to 48 hours
before use. A charge drop can occur after such period, depending
on the battery conditions. If the equipment connected to the DC
source is used for more than 2 hours, connect the ventilator to an
external source (12-volt battery). Use the proper cable (see in this
Chapter: DC Power).
Peak Pressure - Gauge
The ventilator’s gauge keeps the peak pressure indication at each
ventilatory cycle. Such indication is kept for up to 10 seconds in the
absence of any other cycle during this period.
Effort
Respiratory Effort
Indicates (green led) that the patient’s inspiratory effort has reached
the sensitivity level adjusted by the Sensitivity control.
Once the effort is detected, the ventilator will start an assisted or
spontaneous cycle, depending on the selected ventilatory mode.
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Inter® NEO
Operation Manual code 806.00260 Rev. 07
32 - Chapter 3: Controls, Monitors, Indicators and Alarms
MONITORS
I:E Ratio
It displays a digital indication of the ratio between the inspiratory
and expiratory times. For the I:E ratio calculation, both the controlled
cycles and the ones initiated by the patient are considered.
The ratio is presented as follows:
I:E = 1: Exp. T/Insp. T
When the I:E ratio reaches the 3:1 limit (E < 0.33), the I:E Ratio and
INSP TIME displays will start blinking intermittently and the
inspiratory time will be limited in such ratio.
Tidal Vol mL - Resp Rate min-1
Minute Vol L - MAP hPa (cmH2O)
Tidal Volume mL - Respiratory Rate min-1
Minute Volume L - Mean Airway Pressure hPa (cmH O)
2
Depending on the sensor connected to the ventilator, this key
enables selecting the monitoring mode on:
1. Tidal Volume in mL (milliliters) and Total Respiratory Rate
2. Minute Volume L (liters) and Mean Airway Pressure
The Resp Rate display exhibits the total respiratory rate of the
controlled, assisted and spontaneous cycles in which the patient´s
effort reaches the adjusted sensitivity value (SENSITIVITY).
The activation of the led indicates which parameters are being
monitored on the displays.
!
NOTE:
When the acronym CAL is shown on the display, the ventilator will
be indicating that a calibration, auto-zero and flow sensor cleaning
process is in progress.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 33
Lithium Battery End-of-Charge Indicator:
The visual indication bAt on the display Resp Rate min-1 (blinking
for 5 seconds every 1 minute) indicates the end-of-charge of the
lithium battery located inside the equipment and responsible for
storing the last parameters adjusted in the ventilator when it is
turned on again by the POWER switch on the rear panel. In this
case, contact Intermed® at 0800 770 3357 immediately to change
the battery.
Electronic Gauge
The airway pressure measurement made at the patient’s “Y”
connection is performed by a piezoelectric transducer, which
converts the pressure signal into an electric signal. Such signal is
exhibited in a glowing point linear display (leds) in green, in
compliance with the measured pressure.
Indicator Calibrating Range
Each point
corresponds to
From -10 hPa (cmH2O) to 80 hPa (cmH2O)
1 hPa (cmH2O)
During the controlled and assisted cycles, the gauge remains the
point that corresponds to the peak inspiratory pressure of each
cycle lightened.
SCALE: -10 to 80 hPa (cmH O)
2
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Inter® NEO
Operation Manual code 806.00260 Rev. 07
34 - Chapter 3: Controls, Monitors, Indicators and Alarms
Hour Meter
The ventilator presents on I:E Ratio (hours) and Low Press
(minutes) displays the total number of hours it has been in
operation. To access these features, turn on the equipment (Power
switch on rear panel) while pressing the Exp Hold key (on front
panel) at the same time. The indication in the format HHHH:MM
remains on the displays for 10 seconds.
OTHER CONTROLS
Blender
Air and O Blender Valve
2
The BLENDER valve enables adjusting the O percentage used in
the ventilation process.
2
SCALE: 21 to 100% O2
!
WARNING:
The BLENDER is provided with an audible indication to prevent low
air or oxygen pressure. The regular gas inlet pressure for blender
running is 350 kPa. If the inlet pressure difference between the two
gases is above 100 kPa, an internal valve opens to supply the lowpressure gas deficiency, connecting the air and oxygen inlet ways
and triggering the audible alarm. The blender is no longer operative
at this moment and the oxygen percentage in the mix will depend on
the inlet pressure of each gas.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 35
REAR PANEL
Figure 3.2 - Rear Panel of Inter® NEO
REAR PANEL CONFIGURATION
AC POWER INPUT
Automatic Commutation Source
The automatic commutation (Full Range) source enables
connecting the ventilator to the AC sources with a voltage
between 100 V and 240 V.
Power Switch
On / Off Switch
The POWER switch (On/Off) enables connecting a power
supply to the ventilator’s control circuits. The following
situations may occur:
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Inter® NEO
Operation Manual code 806.00260 Rev. 07
36 - Chapter 3: Controls, Monitors, Indicators and Alarms
POSITION OF
THE POWER
SWITCH
POWER
SOURCE
EQUIPMENT
BATTERY
ON
AC Line
Source 100-240
V~
ON and ENERGIZED through
the AC power mains
STAND BY,
receiving charge
ON
DC Line
External 12V
source
ON and ENERGIZED through
the continuous external current
source
STAND BY, not
receiving charge
Int Batt
Internal Battery
ON and ENERGIZED by
internal battery, untill the
minimum limit of charge will
render the ventilator
inoperative
In use, no
recharge
AC Line
OFF
Being recharged
or with full charge
ON
OFF
DC POWER INPUT
Direct Current
The input connector of the direct current (DC) power supply enables
connecting the ventilator to an external source of direct current
between 12-and 14-V and 2A current capacity. This external source
must be connected with an adequate cable, according to the
connector pins:
PIN
CONNECTION
1
NEGATIVE POLE ( - )
2
GROUND (GND)
3
POSITIVE POLE ( + )
The Inter® NEO has an optional connecting cable (cod.
031.00613). Contact Intermed® at 0800 770 3357 for special
models.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 37
RS 232
The connector RS 232 is intended exclusively for the connection
with a PC or equivalent device. For further information, contact
Intermed. When the connector is not being used, keep it protected
with the respective cover.
It is used a DB9 type connector with the following connections:
PIN
CONNECTION
1
NOT USED
2
TXD
3
RXD
4
NOT USED
5
GROUND DIGITAL (GND-D)
6
NOT USED
7
NOT USED
8
NOT USED
9
NOT USED
Alarm Loudness
Alarm Volume
The ALARM LOUDNESS control on the rear panel enables
adjusting the audible alarm volume without a full silencing. Use a
small screwdriver to adjust this control.
Inflating Gas Input
Gas Mixing Inlet
The air and oxygen mix inlet from the blender is made through a
coalescent filter, which removes solid particles up to 0.3 µm and
liquid aerosols up to 0.75 µm from the gaseous mixture. The inlet
pressure must be between 300 and 400 kPa and the pneumatic
supplies (air and oxygen) must be capable of providing a 40 L/min
flow at a 350 kPa pressure.
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Inter® NEO
Operation Manual code 806.00260 Rev. 07
38 - Chapter 3: Controls, Monitors, Indicators and Alarms
Oxygen Cell Input
Oxigen Cell Connection
To connect the oxygen cell, place the sensor cable male terminal
from O into the female connector OXIGEN CELL INPUT (Oxygen
cell connection) located on the ventilator rear panel. The sensor of
O must be connected according to the illustration below, at the
inspiratory branch output located an the left side panel of the Inter
NEO.
2
2
®
Figure 3.3: Connection of the O2 sensor on the left side
panel of Inter® NEO
SIDE PANEL
Figure 3.4 - Side Panel of Inter® NEO
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 39
DETAIL OF SIDE PANNEL CONNECTIONS AND TAGS
Figure 3.5 - Side Panel Detail of Inter® NEO
EXHALATION VALVE CONNECTION
1. Place the diaphragm in the EXHAUST exit (side panel) carefully,
with the salience outward.
2. Insert the exhalation valve as shown in the picture, while checking
the fit position. Slightly turn clockwise.
!
CAUTION:
Place correctly the diaphragm in order to guarantee the perfect
functioning of the valve and to avoid damaging the material.
Figure 3.6 - Exhalation valve connection
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
40 - Chapter 3: Controls, Monitors, Indicators and Alarms
PROXIMAL LINE
Purpose
Pressure measurement at “Y” of the patient circuit.
Figure 3.7 - Detail of the connection to patient proximal line.
NEBULIZER / TGI
Tracheal Gas Nebulization/Insufflation Output
Figure 3.8 - Nebulizer/TGI Connection.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 3: Controls, Monitors, Indicators and Alarms - 41
In the A/C mode, the nebulization flow is of 6 L/min synchronized
with the mandatory cycles inspiratory phase. The tracheal
insufflation flow has also a 6 L/min value, but it is synchronized with
the expiratory phase.
In the SIMV/CPAP mode, a continuous 6 L/min flow can be adjusted
at the Nebulizer/TGI output in both phases or only in the expiratory
phase.
Flow Sensor
Flow Sensor Connection
Purpose
Inspiratory and expiratory flow measurement at Y of the patient
through a pneumotachograph with fixed opening.
!
NOTE:
The expiratory flow information can be viewed at the Current
Volume display. For the inspiratory volume visualization, as well as
of inspiratory and expiratory flow peak, use the graphical monitor
Inter GMX Slim.
®
Figure 3.9 - Through this connection, located on the equipment
left side panel, the flow sensor is incorporated to the ventilator.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
42 - Chapter 3: Controls, Monitors, Indicators and Alarms
The tag fixed on the side panel provides guidance for choosing the
most appropriate flow sensor, as per the patient weight:
Weight inferior to 3 kg (BW<3) - neonatal sensor
Weight between 3 and 25 kg (3<BW<25) - pediatric sensor
Figure 3.10 - Sensor indicative label
O SENSOR
Sensor for O analysis
2
2
The O sensor is an electrochemical type (galvanic cell) and must be
connected at the inspiratory branch exit of Inter NEO and at the
OXYGEN CELL connection (oxygen cell) located on the rear panel,
according to Figure 3.3 of this chapter.
2
®
Purpose
Measuring O concentration on gas delivered to the patient.
2
Figure 3.11 - Cable and O sensor.
2
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 4: Assembly - 43
Chapter 4: Assembly
!
In this Chapter:
! Circuit Assembly
Diaphragm positioning
Exhalation valve connection
Neonatal/Pediatric Patient Circuit Assembly
The correct !
assembly of
Inter® NEO is !
essential
!
for the perfect
functioning of the
equipment.
!
CAUTION:
! The assembly of this equipment must be performed by Intermed®
or the Technical Assistance Service.
! Always use Intermed® ORIGINAL ACCESSORIES,
COMPONENTS AND PARTS to ensure equipment
performance, patient and operator safety and warranty rights.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
44 - Chapter 4: Assembly
!
CAUTION:
! When adding accessories or other components to the
respiratory system, the operator must ensure that the inspiratory
and expiratory resistances, measured at the patient connection
during the spontaneous breathing and normal operation, do not
exceed 6 hPa (cmH2O) for 30 L/min in pediatric use and 6 hPa
(cmH2O) for 6 L/min in neonatal use.
! Skip the steps related to a heated humidifier if it is not being
used. Check the respective instructions when working with other
instruments.
! The gas hoses provided by Intermed follow the Brazilian
standard (Air - yellow / O2 - green). In countries that comply with
EN ISO 5359:2008 standard, the hoses are supplied in white
and black colors for Air and white color for O2.
!
NOTES:
! Intermed® recommends the use of misty 3 humidifier or similar
and IM300 jar or similar, whose descriptions are found in
Chapter 10 of this manual.
! The assembly of Inter® GMX Slim monitor must be performed
only by a technician trained and authorized by Intermed®.
! Instructions for use, characteristics and running of the oximetry
can be found in the operation manual of Inter® GMX Slim.
! Maintenance and Functional Verification Test of the O2 analyzer
can be found in the operation manual of Inter® GMX Slim.
! The alarm setting and calibration of O2 monitoring can be found
in the operation manual of Inter® GMX Slim.
! The O2 sensor connection and the cell cable can be found in the
operation manual of Inter® GMX Slim and in the description of
the rear and side panel of Inter® NEO.
! Sensor selection:
- For flows from 0.2 to 9 L/min use neonatal flow sensor.
- For flows from 2 to 24L/min use pediatric flow sensor.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 4: Assembly - 45
! The silicone pipes, patient circuit polysulfone connections,
polycarbonate flow sensors and humidifying jar supplied by
Intermed® are totally latex free and comply with the cytotoxicity,
irritation, sensitivity and hemocompatibility requirements, thus
complying with the biocompatibility standards.
! Intermed® recomends to assemble Inter® Neo on a pedestal
with casters. However, Inter® Neo may be attached to
appropriate supports together to the bed and the circuit
assembling and mechanic stability is the client’s responsibility.
CIRCUIT ASSEMBLY
1. Fix the Inter NEO on the upper
support of the pedestal, using
screws and lock washers. The front
part of Inter NEO should be
slightly inclined upwards.
®
®
2. Fit the Blender (gas mixer) in the
pedestal front support, fitting it and
sliding it downwards.
3. Connect the Air and O inlet
hoses (from the pipeline) to
the Blender.
2
4. Use the pedestal front rail to fit
the humidifier.
Figure 4.1. Circuit assembly
!
WARNING:
! During usage, keep the equipment in an horizontal position with
locked casters.
! During transportation, collect the articulated arm and keep it
directed to the front part of the equipment.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
46 - Chapter 4: Assembly
DIAPHRAGM POSITIONING AND EXHALATION VALVE CONNECTION
In order to guarantee the perfect positioning of the diaphragm and
the exhalation valve, proceed according to the tag fixed in the side
of the equipment:
1. Turn off the ventilator and place carefully the diaphragm
(130.01362) in the EXHAUST output (side panel) with the salience
facing outward:
Figure 4.2 - Diaphragm in Inter® Neo Side Panel
2. Insert perpendicularly the exhalation valve, checking the sockets
positioning. Slightly turn clockwise.
Figure 4.3 - Exhalation valve connection
!
WARNING:
! Place the diaphragm corretly in order to prevent damages to the
material and to guaratee the valve perfect functioning.
! NEVER incline the valve when placing it in the ventilator nor
insert it with the diaphragm already fitted in order to prevent
damages in the material and to guarantee perfect functioning of
the equipment.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 4: Assembly - 47
NEONATAL/PEDIATRIC PATIENT CIRCUIT
Figure 4.4 - Assembly of Neonatal/Pediatric Circuit
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
48 - Chapter 4: Assembly
DETAIL OF FLOW SENSOR ASSEMBLY
PO
LA
FL
OW
SE
RI
ZE
NT
KEEP IN
VERTICAL
POSITION
PA
TIE
NS
VE
R
NT
ILA
TO
R
OR
13
01
0.0
10
Figure 4.5 - Detail of neonatal flow sensor assembly
(code 136.00347) or pediatric flow sensor (code 136.00311)
at patient’s “Y”.
!
NOTE:
Assemble the flow sensor with its polarizer (black or grey strip)
facing the ventilator side.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 5: Operation - 49
Chapter 5: Operation
!
Follow properly
the
instructions
included in
this
manual to
achieve
the best
equipment
performance.
In this Chapter:
! Introduction
! A/C Mode
! SIMV/CPAP Mode
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
50 - Chapter 5: Operation
INTRODUCTION
1. Always perform the initial check list (Attachment A) before using
the equipment on patients.
2. Clean the equipment and sterilize the accessories before the
first use and before/after using the equipment on each patient (or
more frequently, if necessary), clean the equipment and sterelize the
accessories according to this manual’s instructions in Chapter 7.
!
WARNING:
Always use pressure regulation valves when connecting the
ventilator to the air and oxygen pipelines.
3. Connect the ventilator and the humidifier to the AC power mains
with a grounding system for protection, observing the voltages
indicated in the equipment.
4. Fill the humidifier jar with distilled and sterilized water; adjust the
heating control in the proper position.
!
!
CAUTION:
Constantly monitor the airway gas temperature.
NOTES:
! The equipment has a safety system that keeps monitoring
continuously the microprocessors operation, preventing the
equipment from proceeding in case of failure in the process.
! If the external supply is switched (AC or DC) to internal battery,
the equipment will continue its normal operation. In this case,
note the lighting of the Int Batt (internal battery - in yellow) and
Batt Charge (Battery Charge) leds to ensure the adequate
charging and provide an alternative power source.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 5: Operation - 51
MODE A/C - ASSISTED / CONTROLLED
1. Select the A/C modes
2. Adjust the following controls:
Inspiratory Time - INSP TIME s;
Respiratory rate - RESP RATE min-1;
Expiratory pressure - PEEP hPa (cmH O);
Inspiratory pressure limit - P LIMIT hPa (cmH O);
Continuous flow - FLOW.
Sensitivity - Sensitivity L/min/hPa
2
2
!
NOTES:
! If the INSP TIME and I:E Ratio displays are blinking, it means
that the respiratory rate and inspiratory time adjustments resulted
in an I:E ratio higher than 3:1. In this case, decrease the
inspiratory time or the respiratory rate to reduce the I:E ratio.
! The pressure control (P LIMIT) determines the pressure limit
during the inspiratory phase. This limit is not necessarily
reached, however. Depending on the flow and inspiratory time
adjustments, along with the patient’s breathing mechanics, the
pressure peak may be below the adjusted pressure limit.
3. Set the alarms:
Low inspiratory pressure - Low Press hPa (cmH O);
High inspiratory pressure - High Press hPa (cmH O);
Low expired minute volume - Low Minute Volume L;
Apnea - Apnea s
2
2
!
NOTE:
See the functional alarms and controls description in Chapter 3 of
this manual.
4. Press the Silence/Reset key to clear all visual information related
to alarm conditions created during equipment programming. Check
whether any alarm occurs and change the programming if required.
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Inter® NEO
Operation Manual code 806.00260 Rev. 07
52 - Chapter 5: Operation
5. Keep the controls protection cover always closed to assure that
the adjusted parameters are preserved.
SIMV/CPAP Mode
Intermittent and Synchronized Mandatory Ventilation / Constant
Positive Pressure on Airways
1. Select the SIMV/CPAP and Time Cycle modes.
2. Adjust the controls:
Inspiratory Time - INSP TIME s;
Respiratory rate - RESP RATE min-1;
Expiratory pressure - PEEP hPa (cmH O);
Inspiratory pressure limit - P LIMIT hPa (cmH O);
Pressure Support - P Support hPa (cmH O);
Continuous flow - FLOW.
Sensitivity - Sensitivity L/min/hPa
2
2
2
3. Adjust the alarms:
Low inspiratory pressure - Low Press hPa (cmH O);
High inspiratory pressure - High Press hPa (cmH O);
Low expired minute volume - Low Minute Volume L;
Apnea - Apnea s
2
2
!
NOTE:
See the functional alarms and controls description in Chapter 3 of
this manual.
4. Press the Silence/Reset key to clear all visual information related
to alarm conditions created during equipment programming. Check
whether any alarm occurs and change the programming if needed.
5. Keep the control protection cover always closed to assure that
the adjusted parameters are preserved.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 6: Troubleshooting - 53
Chapter 6: Troubleshooting
!
In this Chapter:
! Troubleshooting Matrix
Some
problems can
be easily
solved by
the user.
!
CAUTION:
Whenever a problem cannot be solved, stop using the equipment
and contact Intermed at 0800 770 3357.
®
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
54 - Chapter 6: Troubleshooting
PROBLEM
Inoperative
Ventilator Alarm
(Vent Inop)
blinking
Minimal
Inspiratory
Pressure Alarm
(Low Press)
blinking
POSSIBLE CAUSE
CORRECTIVE ACTION
1. Power failure and internal battery
discharged;
1. Connect the ventilator to an
external source (AC or DC).
2. Gas inlet pressure (air and
oxygen) below 250 kPa.
2. Increase air and/or oxygen inlet pressure
to 350 kPa.
3. Electronic failure
3. Contact Intermed® at 0800 770 3357.
1. Leakage in patient’s circuit
and/or endotracheal tube;
1. Locate and fix the leakage;
2. Change in patient’s respiratory
mechanism: reduced
resistance and/or increased
compliance;
2. Reassess the ventilatory
parameters (volume, inspiratory pressure,
PEEP) and/or the alarm;
3. Obstruction in the
inspiratory branch of
patient’s circuit;
3. Locate and fix the obstruction;
4. Disconnection
of patient’s circuit;
4. Reconnect the patient’s circuit;
5. Damaged or incorrectly
assembled exhalation valve diaphragm;
5. Change or replace CORRECTLY the
diaphragm;
6. The inspiratory flow is not
enough to supply patient’s inspiratory
effort;
6. Increase the inspiratory flow;
7. Incorrectly adjusted alarm;
7. Set the alarm between PEEP
and inspiratory pressure peak of the
cycles presenting the lowest peak value;
8. Failure in the control system of
the exhalation valve.
8. Contact Intermed® at 0800 770 3357.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 6: Troubleshooting - 55
PROBLEM
High
Pressure Alarm
(High Press)
blinking
I:E Ratio and
INSP TIME
displays
blinking
Numeric display
with oscillation in
Exhaled Volume
value
POSSIBLE CAUSE
CORRECTIVE ACTION
1. Change in patient’s respiratory
mechanism: increased
resistance and/or reduced
compliance
1. Reassess volume and flow adjusted
parameters;
2. Obstruction / secretion accumulation in
the endotracheal tube and/or
patient’s airway
2. Clear / aspirate the airway and/or the
endotracheal tube;
3. Obstruction in the expiratory branch of
patient’s circuit and/or exhalation valve
3. Clear the expiratory branch;
4. Incorrectly adjusted alarm.
4. Set the alarm above the peak
pressure or controlled/support
pressure already set.
1. I:E ratio reached the limit 3:1
(I:E Ratio > 3:1), i.e. the inspiratory
time is 3 times higher than the
expiratory time.
1. Reduce the inspiratory time;
reduce the respiratory rate to
increase the expiratory time.
1. Obstruction of pneumotachograph (flow sensor)
1. The pneumotachograph.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
56 - Chapter 6: Troubleshooting
PROBLEM
Apnea alarm
(Apnea)
POSSIBLE CAUSE
CORRECTIVE ACTION
1. The patient could not trigger
the assisted and/or spontaneous cycles.
1. Check if the adjusted sensitivity
(Sensitivity) is compatible with patient’s
inspiratory effort; readjust the sensitivity.
2. The interval between two
consecutive respiratory cycles
reached the limit adjusted in the
apnea alarm.
2. Check if the patient entered into
apnea; reassess the
adjusted ventilation parameters (respiratory
rate, pressure support)
3. Inadequate adjust of the alarm.
3. Reset the apnea interval
according to the respiratory rate.
Resp Rate
display
indicating “bAt”
1. Discharged lithium battery
located inside the equipment.
1. Stop using the equipment
and contact Intermed® at 0800 770 3357.
Low Minute
Volume audible/
visual alarm and
“AEr” visual
indication blinking
intermittently in
Tidal Vol L display
1. Failure in reference (0 L/min)
flow valve.
1. Stop using the equipment
and contact Intermed® at 0800 770 3357.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 6: Troubleshooting - 57
PROBLEM
Visual indication
Int Batt blinking
in yellow
POSSIBLE CAUSE
CORRECTIVE ACTION
1. Ventilator switched the
external AC source (AC Line) to
internal battery (Int Batt) and
requires the operator to
confirm perceiving the
switch.
1. Press the Silence/Reset key to
proceed in normal operation.
1. Inlet gas pressure from
blender is less than 250 kPa.
1. Increase inlet air and/or oxygen
pressure to 350 kPa.
2. Coalescent filter in the gas
inlet is satured.
2. Replace the filter.
3. Blender filter is satured.
3. Contact Intermed® at 0800 770 3357
Visual indication
Batt Charge
blinking in red;
(intermittent
audible alarm)
1. Battery reaching the range of
minimum charge level.
1. Connect the ventilator to power
mains or a 12VDC external source.
Total Resp Rate
Display blinking
“FAN” every
20 seconds
1. Failure in the cooling system
(fan) of the equipment
1. Do not use the equipment and
contact Intermed® at 0800 770 3357.
Visual indication
Gas Fail blinking
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
58 - Chapter 6: Troubleshooting
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 7: Cleaning and Sterilization - 59
Chapter 7: Cleaning and
Sterilization
!
The equipment
and
accessories
durability
depends on
appropriate
cleaning.
!
In this Chapter:
! Inter NEO Ventilator and Inter GMX Slim Monitor
! Air inlet filter for cooling
! Patient’s Circuit
®
®
CAUTION:
! Before using the equipment for the first time and before and after
using it on each patient (and more frequently, if necessary),
CLEAN the equipment and sterilize its accessories.
! After sterilizing, rinse and dry the accessories appropriately to
eliminate any residues.
!
WARNING:
! Sterilized components suffer natural degradation due to the
characteristics of the processes used. Intermed® recommends
no more than 50 cycles for cleaning/sterilizing circuit
components, even if performed according to the conditions
specified in the Indicated Process Table in this chapter.
! Do not reuse components presenting any damage or sign of
wear.
!
NOTE:
Skip the steps related to a heated humidifier if it is not being used.
Check the respective instructions when working with other
instruments.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
60 - Chapter 7: Cleaning and Sterilization
VENTILATOR AND MONITOR
Cleaning and disinfection of the outer part of Inter NEO Ventilator
and Inter GMX Slim Monitor, except for the control panel, can be
done with an appropriate germicidal or bactericidial agent.
®
®
The control panel may be cleaned with a wet gauze with 70%
Isopropyl Alcohol.
Eliminate eventual obstructions in the cooling air inlet filter.
!
WARNING:
! NEVER sterilize the equipment.
! NEVER place the equipment in a liquid solution.
! NEVER use abrasives on equipment surface.
! NEVER allow liquid to enter inside the equipment.
! NEVER use alcohol to clean the rear panel since the lettering
may be damaged.
! THE DISINFECTION is a process capable of destroying
pathogenic microorganisms, BUT IT CANNOT destroy spores.
The spores are only destroyed by STERILIZATION.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 7: Cleaning and Sterilization - 61
COOLING AIR INLET FILTER
Daily, or before use, check and clean the cooling air inlet filter.
1. Pull carefully, through the sides, the filter protection tilting cover
located at the bottom below the equipment front panel.
2. Remove the filter.
3. Wash manually and carefully in warm water and neutral detergent.
4. Rinse well and dry completely.
5. Check for possible damages in the filter, replacing it if necessary.
6. Put back the filter in place.
7. Close the cover, pressing it slightly in the side to lock it.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
62 - Chapter 7: Cleaning and Sterilization
PATIENT’S CIRCUIT
Recommended Processes for Cleaning and Sterilization
Material
Processes
Trachea Silicone Tubes
codes 100.19002; 100.19003
Proximal Pressure Silicone Tube
code 100.00117
“Y” Connector (Polysulfone)
code 100.00113
L+D
90º Elbow (Polysulfone)
code 100.00104
L + EQ
Water Trap (Polysulfone)
code 100.00105
L + AC
Exhalation Valve Body (Polysulfone)
code 150.00550
L+ ETO
Exhalation Valve Diaphragm (Silicone)
code 130.01362
L+D
Flow sensors
codes 136.00311 and 136.00347
L + EQ
L + ETO
Legend:
L
D
EQ
AC
ETO
INTERMED®
: Washing
: Chemical Disinfection by Immersion
: Chemical Sterilization by Immersion
: Autoclave
: Ethylene Oxide
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 7: Cleaning and Sterilization - 63
Washing
BEFORE any disinfection or sterilization process, washing should
be carried out by immersion in a neutral solution with enzymatic
detergent, at a temperature between 35 and 65oC, for
approximately 10 minutes. Rinse with distilled or filtered water to
eliminate high concentration of chemical substances that may affect
the materials. Let it dry in a clean environment before proceeding
with the disinfection or sterilization.
!
WARNING:
DO NOT USE
Phenol (>5%)
Chlorinated Hydrocarbons
Ketones
Aromatic Hydrocarbons
Formaldehyde
Inorganic Acids
Hypochlorite
Quaternary Ammonium Compounds
These solutions may cause cracks in polysulfone components or
disintegration of silicone pipes. Do not use these solutions in
washing processes that precede autoclave sterilization and
pasteurization, since they can accelerate materials deterioration.
Chemical Disinfection by Immersion
Chemical disinfection by immersion can be performed using a 2%
Glutaraldehyde solution (Cidex ) for a period of 40 MINUTES.
Rinse with distilled and sterilized water to eliminate high
concentrations of chemical substances used. Let it dry in a clean
environment.
®
Chemical Sterilization by Immersion
Chemical sterilization by immersion can be performed using a 2%
Glutaraldehyde solution (Cidex ) for a period of 12 HOURS. Rinse
with distilled and sterilized water to eliminate high concentrations of
chemical substances used, letting it dry in a clean environment.
®
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
64 - Chapter 7: Cleaning and Sterilization
Autoclave
The autoclave sterilization procedure shall meet the following
parameters:
CONDITION
PRESSURE
TEMPERATURE
TIME*
Fast
220 kPa (32 PSI)
136ºC (276.8ºF)
4 minutes
Normal
96 kPa (14 PSI)
120ºC (248ºF)
15 minutes
* Sterilization time under temperature and pressure conditions.
ETO - ETHYLENE OXIDE (C2H4O)
A sterilization procedure using Ethylene Oxide gas shall comply with
Standard EN ISO 11135-1:2007.
!
WARNING:
! After sterilizing in Ethylene Oxide, wait from 24 to 48 hours
before using the material, to ensure its aeration and the escape
of any residual gas.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 8: Accessories, Components and Parts - 65
Chapter 8: Accessories,
Components and Parts
!
Always use
original
accessories
and
components.
!
In this Chapter:
! Accessories, Components and Parts
CAUTION:
! Always use Intermed® ORIGINAL ACCESSORIES,
COMPONENTS AND PARTS to ensure equipment
performance, warranty rights and patient and operator safety.
! When adding accessories or other components to the
respiratory system, the operator must ensure that the inspiratory
and expiratory resistances, measured at the patient connection
during the spontaneous breathing and normal operation, do not
exceed 6 hPa (cmH O) for 30 L/min in pediatric use and 6 hPa
(cmH O) for 6 L/min in neonatal use.
2
2
! Never use anti-static or electrically conductive hoses or tubes in
conjunction with the ventilator.
! All patient circuit components supplied by Intermed® (silicone
tubes, polysulfone connections and polycarbonate flow sensors)
comply with all cytotoxicity, irritation, sensitivity and
hemocompatibility requirements and are, therefore, in
accordance with the biocompatibility stardards.
! The patient circuit supplied by Intermed® offers protection
against electric shock (part applied TYPE B) and is defibrillationproof.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
66 - Chapter 8: Accessories, Components and Parts
ACCESSORIES, COMPONENTS AND PARTS
The Inter NEO ventilator accessories, components and parts are
listed below and shown in figures 4.1 to 4.5 of Chapter 4.
®
CODE
152.00000A
DESCRIPTION
®
Inter Neo VENTILATOR
150.01100
Pedestal
131.00950
Blender with Air and O2 Hoses
150.01000
Articulated Arm
MANDATORY ACCESSORIES
100.19000
Neonatal / Pediatric Patient’s Circuit
136.00347
Neonatal Flow Sensor
136.00311
Pediatric Flow Sensor
OPTIONAL/RECOMMENDED ACCESSORIES
151.00000C EP3
Inter® GMX Slim graphic ventilation Monitor
151.00900
Oxygen Cell
134.00000 or
134.00000C
140.00000 or 140.00000C
INTERMED®
Misty 3 Heated Humidifier
Inter® 3500 Compressor
177.01000
Inter® 7 Plus Articulated Arm
177.01100
Inter® 7 Plus Pedestal
100.00202
90º Connector for TGI
158.00000
Neonatal Pulmonary Simulator LS1000
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 8: Accessories, Components and Parts - 67
CODE
DESCRIPTION
COMPONENTS AND PARTS
152.00000A
INTERMED®
Inter® Neo VENTILATOR (ventilator only)
150.01100
Pedestal
131.00950
Blender with Air and O2 hoses
130.01400
Blender (without hoses)
408.00003
F/F Air Hoses
408.00002
F/F Oxygen Hoses
130.01421
O2 Ventilator Hoses
150.01000
Articulated Arm
100.00105
Water Trap
100.00103
22Mx15F Polysulfone Connector
100.00113
“Y” Connection Neo/Ped Circuit
100.19002
45cm Pediatric Silicone Trachea Tube
100.19003
60cm Pediatric Silicone Trachea Tube
100.00117
Neonatal Silicone Proximal Line Tube
150.00550
Exhalation Valve
130.01362
Exhalation Valve Diaphragm
136.00347
Neonatal Flow Sensor
136.00311
Pediatric Flow Sensor
177.01000
Inter® 7 Plus Articulated Arm
177.01100
Inter® 7 Plus Pedestal
100.00202
90º Connector for TGI
100.20000
Neonatal/Pediatric Patient Circuit without Drain
Inter® NEO
Operation Manual code 806.00260 Rev. 07
68 - Chapter 8: Accessories, Components and Parts
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 9: Preventive Maintenance - 69
Chapter 9: Preventive Maintenance
!
Follow the
preventive
maintenance plan
correctly.
!
In this Chapter:
! Functional Verification Test - FVT
! Regular Preventive Maintenance
! Annual Preventive Maintenance - APM
WARNING:
! The ventilator is a life-supporting equipment. Never entrust the
maintenance of this equipment to unauthorized personnel.
Contact Intermed® at 0800 770 3357.
! The equipment has safety SEALS in the closing screws.
Breaking these seals by non-authorized personnel may void the
equipment WARRANTY.
! All parts and components replaced during the maintenance
processes should be discarded as determined by the local
legislation where the equipment is installed. Special attention
must be given to the internal lead-acid battery that should follow
its manufacturer’s guidance, described on the side part of the
equipment.
! Never use the ventilator when it is not operating within the
specifications shown in the manual. Contact Intermed® at 0800
770 3357.
Never disassemble the ventilator cabinet. This situation represents
risk of electric shock.
To ensure electrical protection and to avoid any risk of fire,
never substitute the fuses of this equipment. The undue
replacement of fuses shall render the warranty void and represents
risk to equipment operation and to operator and patient safety.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
70 - Chapter 9: Preventive Maintenance
!
CAUTION:
To prevent premature equipment wearing and to achieve a safe
performance and within the required specifications, the following
should be done:
! Routine Preventive Maintenance
It must be carried out DAILY or before each use, according to this
chapter instructions.
! Functional Verification Test - FVT
It must be performed before using it in patients or in view of doubts
on the equipment operation.
! Annual Preventive Maintenance - APM
Request ANNUALLY equipment checking, adjustment and
calibration, performed solely by Intermed® or Intermed® Technical
Assistance Service.
FUNCTIONAL VERIFICATION TEST - FVT
The FVT is a test which enables to verify if the ventilator is operating
in accordance with specifications and it must be performed by the
operator at least once a month, or in view of doubts on ventilator’s
operation.
Do the FVT according to the steps in the check list fixed on the
pedestal of the equipment.
Whenever a problem cannot be solved during the FVT, stop using
the equipment and contact Intermed® at 0800 770 3357.
!
CAUTION:
! For the FVT performance, the ventilator must be disconnected
from the patient.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 9: Preventive Maintenance - 71
REGULAR PREVENTIVE MAINTENANCE
Daily or before using:
- Check the alarm system;
- Check and remove water from the inlet filter bowl;
- Check the grounding conditions and the integrity of the socket
and equipment’s power supply cable (plug);
- Check the integrity of the air/oxygen supply hoses; Contact
Intermed® at 0800 770 3357 in case of problems;
- Activate the relief valve at the equipment’s rear panel so as to
eliminate possible condensed water in the reservoir;
- Check the integrity of the patient circuit; eliminate possible
leakages due to the assembly or replace the circuit if necessary;
- Check the working of the patient circuit’s sustaining arm and
the caster locks on the pedestal;
- Check and eliminate possible obstructions in the air inlet filter;
- Check the internal battery load level and keep the ventilator
connected to the power mains until the battery is fully charged, if
necessary;
- Check the equipment’s general state so as to ensure that it did
not suffer any falls or damages that might compromise its safe
working; Contact Intermed at 0800 770 3357 in case of doubts
or problems;
- Check the equipment’s cleaning state, proceeding in
accordance with Chapter 7;
- Sterilize the patient circuit according to Chapter 7 and/or
institution’s procedures;
®
- Carry out the Functional Verification Test - FVT. Contact
Intermed at 0800 770 3357 in case of problems.
®
- Request the Annual Preventive Maintenance - APM, including
the equipment verification, adjustment and calibration,
performed exclusively by Intermed® or Intermed® Technical
Assistance Service.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
72 - Chapter 9: Preventive Maintenance
INTERNAL BATTERIES
The Inter Neo is provided with two internal batteries:
®
Sealed acid-lead type battery
This internal battery is protected against leakage and does not
require specific maintenance in addition to precautions to ensure
proper charging and storage conditions.
If the battery is removed or its useful life has expired, the ventilator
will continue working normally provided it is supplied by one of the
other power sources for the equipment.
The internal battery is charged by means of an electronic charging
circuit incorporated to the ventilator, whenever the latter is
connected to the AC power mains, including when the ventilator is
being used.
For a ventilator that is not frequently used, the internal battery must
be recharged at least once every two months and before using the
ventilator.
The maximum load level is reached after approximately 10 hours,
depending on the current load level. See the battery load level in the
led Batt Charge on the front panel (see Chapter 3 of this manual).
!
WARNING:
- Storing the ventilator for prolonged periods under temperatures
higher than 27oC or without recharging the battery for periods longer
than two months may reduce the battery’s useful life.
- The battery has a useful life of up to 12 months and depends on
the conditions in which the ventilator is used (frequency and time of
ventilator use and/or the internal battery, temperature and humidity
environmental conditions, etc).
Lithium Battery
The Inter® Neo has a lithium battery that allows storing the last
parameters adjusted in the equipment is ventilator when this is
turned on again by the POWER switch in the rear panel, which is an
important additional safety resourse.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 9: Preventive Maintenance - 73
As soon as the ventilator exhibits the bAt indication on the display
Resp Rate min-1, ask for its replacement to Intermed® or Intermed®
Technical Assistance Service, as described in the Chapter 3 of this
Manual.
Internal Batteries Replacement
The internal batteries should be replaced by Intermed® Technical
Assistance Service. After replacing it, dispose the old battery
according to the tag attached to the product and in compliance with
the local legislation.
Disposal of Internal Battery and other materials:
The Inter NEO ventilator and Inter GMX Slim monitor contain
components (internal batteries and integrated circuit boards with
capacitors and liquid crystal display) that should be disposed
according to the local environmental legislation.
®
®
The internal battery has the following symbol:
SYMBOL
STANDARD
DESCRIPTION
DIRECTIVE
91/157/EEC
SELECTIVE COLLECTION
CONTATINS HEAVY METAL (Pb)
Equipment maintenance should be performed by Intermed®
Technical Assistance Service only, which shall adopt the necessary
procedures for proper disposal of the electro-electronic
components.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
74 - Chapter 9: Preventive Maintenance
ANNUAL PREVENTIVE MAINTENANCE- APM
The Annual Preventive Maintenance - MPA is a unique service
offered by Intermed to extend the durability of the equipment and to
ensure its safe operation within the original specifications and
requirements of standards NBR IEC 60601-1:2004 and 1997
amendment; NBR IEC 60601-2-12:2004; EN 60601-1:1990/
A1:1993/A2:1995 and EN 60601-2-12:2006.
®
APM consists basically of adjustment, calibration and inspecting all
the equipment’s functions and replacement of defective
components presenting wearing or deterioration due to use.
Inspection, adjustment and calibration are carried out by Intermed®
or Intermed® Technical Assistance Service with traceable
measuring equipment to internationally recognized metrological
standards, and in compliance with requirements of the ISO 9001/
2008 Quality System.
APM should be performed following the conditions below:
1. The customer should contact Intermed or Intermed® Technical
Assistance Service after using the equipment for 12 months to
perform the APM - 0800 770 3357;
®
2. APM must be performed at Intermed® facilities or by Intermed®
Technical Assistance Service, the customer being responsible for
freight;
3. When performed within the WARRANTY period, the conditions
established in Chapter 11 of this manual will be applicable.
4. APM is limited to equipment; the accessories are not included.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 75
Chapter 10: Technical Description
!
In this Chapter:
Always use the
Operation
Manual
as reference.
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
!
INTERMED®
Classification
Controls
Monitors
Indicators
Flow Sensors
Oxygen Sensor
Alarms
Electrical Input
Lithium Battery
Pneumatic Input
Blender
Ventilation System / Patient Circuit
Intermed® Misty 3 humidifier
Intermed® IM300 Jar
Physical Characteristics
Environmental Specifications
Electromagnetic interference immunity levels
Inter® NEO
Operation Manual code 806.00260 Rev. 07
76 - Chapter 10: Technical Description
CLASSIFICATION
According to the type of protection
against electric shock
Class I /
Internally Energized Equipment
According to the type of protection
against electric shock
Type B applied part
According to the type of protection
against hazardous water entering
IP24
According to the mode of operation
Continuous Operation
Equipment not suitable for use in the presence of an anesthetic
mixture flammable with air, oxygen or nitrous oxide.
NBR IEC 60601-1:1994/A1:1997; NBR IEC 60601-1-2:2006; NBR IEC 60601-2-12:2004;
EN 60601-1:1990/A1:1993/A2:1995; EN 60601-1-2:2001/A1:2004; EN 60601-2-12:2006
94/42:2003/EEC - Medical Device - Class IIb rule 9
!
Note:
All measured flow and volume values are expressed in BTPS (Body
Temperature and Pressure, Saturated).
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 77
CONTROLS
Modes
RANGE
TOLERANCE
A/C
SIMV/CPAP
Regular: 350 kPa
Range: 300 to 400 kPa
±5%
Inlet Working Pressure
Maximum Working Pressure
80 hPa (cmH2O )
±5%
Minimum Pressure Limiting
(sub-environment)
-10 hPa (cmH2O )
±5%
Minimum 0.10s
Maximum 15s
±5%
Inspiratory Time
Minimum 0 min-1
Maximum 180 min-1
±5%
Respiratory Rate
Minimum 2 L/min
Maximum 30 L/min
±10%
Inspiratory Flow (controled)
Inspiratory Flow (demand)
Expiratory Flow
Minimum 0 L/min
Maximum 30 L/min
±10%
Adjusted inspiratory flow
(from 2 L/min to 30 L/min)
±10%
Minimum 5 hPa (cmH2O)
Maximum 70 hPa (cmH2O)
±5%
Pressure Limit
Minimum 0 hPa (cmH2O)
Maximum 50 hPa (cmH2O)
±5%
Pressure Support
Minimum 0 hPa (cmH2O)
Maximum 50 hPa (cmH2O)
±5%
PEEP/CPAP
Inspiratory Sensitivity by pressure
(disconnected sensor or during self
calibration)
Minimum 0.5 hPa (cmH2O)
Maximum 10 hPa (cmH2O)
±5%
Inspiratory Sensitivity by flow
Neonatal sensor
0.2 L/min to 2 L/min
Disabled ( - - )
±0,2 L/min
Inspiratory Sensitivity by flow
Pediatric sensor
0.5 L/min to 5 L/min
Disabled ( - - )
±10%
O2 Concentration (blender)
21 to 100%
±5%
Manual Inspiratory Pause
Maximum 15 seconds
±5%
Manual Expiratory Pause
Maximum 15 seconds
±5%
AC Mode
6 L/min (inspiratory phase)
±10%
SIMV/CPAP Mode
6 L/min (continuous flow)
±10%
AC Mode
6 L/min (expiratory phase)
±10%
SIMV/CPAP Mode
6 L/min (continuous flow or synchronized)
in the expiratory phase)
±10%
Nebulization
TGI
Apnea Interval
OFF (15 sec.)
4 sec to 30 sec
Manual Cycle
Controlled cycle started by the operator
Silence / Visual Reset
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
78 - Chapter 10: Technical Description
MONITORS
RANGES
TOLERANCE
Tidal Volume
from 0.00 to 999 mL
±10%
Minute Volume
from 0.00 to 99.9 L
±10%
Respiratory Rate
from 0 to 180 min-1
±5%
I :E Ratio
from 1:99 to 9,9:1
±5%
Airway pressure
from -10 to 80 hPa (cmH2O)
±5%
Mean Airway pressure
from 0 to 80 hPa (cmH2O)
±5%
Peak pressure
from 0 to 80 hPa (cmH2O)
±5%
Temperature (humidifier)
from 24 to 40°C
±10%
O2 Analyzer (Inter® GMX)
from 18 to 100%; OFF
±10%
Working Hours
0 to 9999:99
N/A
INDICATORS
Sensitivity (hPa) during self calibration or
sensor disconnected
Green led (see page 21)
Silence (alarm silenced)
Yellow led (see page 25)
Power (On)
Green led (see page 29)
AC Line (AC power source)
Green led (see page 30)
DC Line (DC power source)
Green led (see page 30)
Int Batt (Internal battery)
Yellow led (see page 30) Green Led (see page 30)
Green led (fully charged)
endurance from 120 to 60 minutes
Batt Charge (Battery charge level) see page 30
Orange led (half charge)
endurance from 60 to 15 minutes
Intermittent Red led (low charge)
less than 15 minutes of endurance
Effort (inspiratory effort)
INTERMED®
Green led (see page 31)
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 79
ALARMS
RANGE
TOLERANCE
Low Press
(Low Inspiratory Pressure)
High priority audible
and visual alarm
(red led)
3 to 70 hPa (cmH2O )
±5%
High PEEP
(High Expiratory Pressure)
High priority audible
and visual alarm
(red led)
10 to 65 hPa (cmH2O )
±5%
High Press
(High Inspiratory Pressure)
High priority audible
and visual alarm
(red led)
10 to 80 hPa (cmH2O )
±5%
Low Minute Volume
(Low Minute Volume) /Patient
disconnection
Apnea / Back up
(may be disabled)
Medium priority audible
and visual alarm (yellow led)
OFF; 0.05 to 10L
High priority audible
and visual alarm (red led)
After 3 cycles for Adult/
pediatric patients and 6
for Neonatal patients
Medium priority audible
and visual alarm
(yellow led)
OFF: 15 s
from 1 to
to 30 seconds
±5%
< 130 kPa
±5%
Power Fail (failure
of power)
High priority audible
and visual alarm
(red led)
Gas Fail (failure in
the gas inlet pressure)
High priority audible
and visual alarm
(red led)
Inop Vent
(Inoperative Ventilator)
High priority audible
and visual alarm
(red led)
INTERMED®
Inter® NEO
±10%
Operation Manual code 806.00260 Rev. 07
80 - Chapter 10: Technical Description
FLOW SENSORS
Range
Tolerance
Neonatal Clearance (internal volume): 0.8mL
0.2 to 9
L/min
±5% or 0.2 L/min
Pediatric Clearance (internal volume): 0.8mL
2 to 24
L/min
±5% or 0.5 L/min
Maximum deviation according to gas composition (at
100% of O2 , calibrated sensor to 21% of O2)
< 4%
Maximum deviation according to gas temperature
See the following graph:
Measured Volume / Actual Volume
Volume - Temperature Ratio
Temperature (°C)
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 81
Accessory: O2 concentration sensor
Type of sensor
Galvanic Cell
Measurement Range
from 0 to 100%
for 90% of response
< 15s
for 97% of response
< 25s
Above the range of
operating temperature
2.0%
At constant temperature and pressure
1.0%
Response Time
Accuracy (% of full-scale)
Operating Temperature
0° to 40° C
(32° to 104° F)
Storage Temperature
-15° to 50° C
(5° to 122° F)
Operating Humidity (non-condensed)
0 to 95%
Usage Time
900.000 h / % O2
Stability (above 8 hours of use at constant temperature and pressure)
INTERMED®
Inter® NEO
< 1%
Operation Manual code 806.00260 Rev. 07
82 - Chapter 10: Technical Description
Accessory: Patient´s circuit
Parameter
Inspiratory Resistance
(under normal usage
conditions)
Inspiratory Resistance
(under equipment
failure conditions)
Expiratory Resistance
(under normal usage
conditions)
Expiratory Resistance
(under equipment failure
conditions)
Circuit compliance
without the jar
Circuit compliance
with the jar
Internal Volume Circuit
without the jar
Internal Volume Circuit
with the jar
INTERMED®
Value
Tolerance
Pediatric
Flow of 30 L/min
< 0.2 hPa
± 10%
Neonatal
Flow of 6 L/min
< 0.03 hPa
± 10%
Pediatric
Flow of 30 L/min
< 2 hPa
± 10%
Neonatal
Flow of 6 L/min
< 0.2 hPa
± 10%
Pediatric
Flow of 30 L/min
< 0.3 hPa
± 10%
Neonatal
Flow of 6 L/min
< 0.05 hPa
± 10%
Pediatric
Flow of 30 L/min
< 0.8 hPa
± 10%
Neonatal
Flow of 6 L/min
< 0.06 hPa
± 10%
Pediatric
mL/hPa (cmH2O )
0.60
± 10%
Neonatal
mL/hPa (cmH2O )
0.60
± 10%
Pediatric
mL/hPa (cmH2O )
1.08
± 10%
Neonatal
mL/hPa (cmH2O )
1.08
± 10%
Pediatric
mL
445
± 5%
Neonatal
mL
445
± 5%
Pediatric
mL
845
± 5%
Neonatal
mL
845
± 5%
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 83
POWER SUPPLY
100V ~ 240V
0.22 ~0.50A
Voltage/Current Full Range
Source (automatic switch)
Frequency
50/60Hz
Internal battery (lead-acid)
12V - 2.2 A/h
External power source
12-14V - 2 A/h
Fuse
2A - 250V SB
Internal Power Supply
Type
Lithium battery
Nominal Voltage (V)
3
Nominal Capacity (mA.h)
220
Operating Temperature (oC)
-30 to +60
PNEUMATIC INLET
TOLERANCE
Air and oxygen
300 kPa to 400 kPa
±12 kPa or 4%
±16 kPa or 4%
Always use medical grade gas (dry and free from contaminants),
according to ISO 8573.
BLENDER (AIR/O2 MIXER)
Air/O2 inlet pressure
O2
Flow
Accuracy
RANGE
TOLERANCE
from 200 kPa
to 500 kPa
±8 kPa or 4%
±20 kPa or 4%
21 to 100%
-
from 1 L/min to 100 L/min
(For continuous flow in the outlet)
±0,1 L/min or 10%
±10 L/min or 10%
±3%
Visual indication / bypass / O2
Whenever the difference between
air and O2 inlet pressure
exceeds 100 kPa
±6 kPa or 4%
Escape flow
ON: 9 L/min @ 350 kPa OFF: 0 L/min
± 0.9 L/min or 10%
Dimensions
7.6x3.8x7.4cm
Weight
INTERMED®
0.65 kg
Inter® NEO
Operation Manual code 806.00260 Rev. 07
84 - Chapter 10: Technical Description
MISTY 3 INTERMED HUMIDIFIER
Thermal protection on heating
base
max. 93ºC
Accuracy
3%
Flow operating range
> 0 to 120 L/min
Pressure operating range
> 0 to 12 kPa (120 cmH2O)
IM300 INTERMED JAR
Maximum level (useful volume)
280mL
Operational volume
200mL
Minimum level
80mL
full - maximum level: 1mL/kPa
Compliance
minimum level: 3mL/kPa
empty: 4mL/kPa
Pressure drop to 30 L/min
0.01 kPa
Maximum Flow
180 L/min
Maximum operation pressure
INTERMED®
Inter® NEO
150 hPa (15 kPa)
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 85
PHYSICAL
CHARACTERISTICS
PARAMETER
VALUE
Height
160 mm
Width
290 mm
Depth
315 mm
Ventilator
12 kg
Graphic Monitor
1 kg
Pedestal
18 kg
Complete Equipment
31 kg
(including arm and circuits)
Size (ventilator)
Weight
ENVIRONMENTAL SPECIFICATIONS
Operating
RANGE
+5 to +40ºC
Room Temperature
Storage/Transport
-10 to +40ºC*
Operating
15 to 95%
Storage/Transport
10 to 95%
Relative Humidity
Operating
70 to 106 kPa
Storage/Transport
50 to 106 kPa
Atmospheric pressure
!
WARNING:
(*) Storing the ventilator for prolonged periods under temperatures
higher than 27oC or without recharging the battery for periods longer
than two months may reduce the battery’s useful life.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
86 - Chapter 10: Technical Description
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 87
!
Note for Electromagnetic Compatibility:
This equipment was developed, tested and certified in accordance
with the limits established in NBR IEC 60601-1-2:2006 and EN
60601-1-2:2001/A1:2004 for Class I/Internally Powered
electromedical equipment, and 93/42:2003/EEC - Medical Device
Class IIb rule 9, following CISPR 11 standardization.
The limits are intended to offer protection against prejudicial
interference in its installation and operation, according to the
immunity levels defined for the electromagnetic interference for the
equipment connected on patient, as per technical description and
use in compliance with this manual.
This equipment when exposed to adverse situations to its
specification can produce or suffer electromagnetic interference.
In order to avoid prejudicial interferences it is mandatory to:
- Observe the distances between this equipment and other possible
IEM emitters;
- Only connect the equipment to a grounded outlet for protection;
- Never disable the grounding terminal in the power cable plug of
the equipment.
In case of doubts, always call Intermed at 0800 770 3357.
®
Restrictions:
The non-authorized modification of any elements or components
which operation may be affected by electromagnetic fields
invalidates the product warranty and may produce adverse
operating results.
Do not operate the equipment out of the described conditions and
in a magnetic resonance environment or near to high frequency
surgical equipment, defibrillators or short wave therapy equipment.
The electromagnetic interference may jeopardize this equipment
operation.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
88 - Chapter 10: Technical Description
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 10: Technical Description - 89
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
90 - Chapter 10: Technical Description
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Chapter 11: Warranty - 91
Chapter 11: Warranty
!
Read the
warranty
conditions
attentively.
In case of
doubts or
problems,
always
request for
assistance
from the
authorized
representative.
Intermed Equipamento Médico Hospitalar Ltda. products are
warranted against material and manufacturing defects and comply
with the published characteristics. The warranty and technical
assistance are assured by Intermed Equipamento Médico
Hospitalar Ltda. and its Authorized Service in the whole national
territory and in countries where Authorized Service is available.
The equipment has safety SEALS in the closing screws. Breaking
this seals by non-authorized personnel may result in the equipment
WARRANTY loss.
Responsibility for the warranty is limited to replacement, repair and
labor, at the manufacturer’s discretion, for components presenting
defect or not meeting the characteristics published during the
warranty period.
The warranty does not cover defects caused by accident, improper
use, use conditions, improper installation or sterilization, service,
installation, operation or alteration performed by non-authorized or
unqualified personnel.
Parts subject to wearing or normal deterioration from usage,
adverse usage conditions, inadvertent usage or accidents are not
covered by the WARRANTY.
The granted warranty period is 12 months for the equipment, 180
days for the battery and 60 days for accessories, provided that their
original characteristics are maintained, counted as of the
equipment delivery date or according to specific contractual
conditions agreed upon.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
92 - Chapter 11: Warranty
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Attachment A: Initial Check List - 93
Attachment A: Initial Check List
WARNING:
!
Before using the equipment always perform the check list (initial
checking) with the equipment disconnected from the
patient.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
94 - Attachment A: Initial Check List
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Attachment B: Symbols and Terminology - 95
Attachment B: Symbols and
Terminology
Symbols
1.The meaning of standard symbols, printed on the
equipment, is shown below:
Symbol
IP24
Standard
Description
IEC60601-1:1994
Symbol No.
417-5032
Alternating Current
IEC60601-1:1994
Symbol No.
417-5031
Continuous Current
IEC60601-1:1994
Symbol No.
417-5019
Grounding terminal
for
protection
IEC60601-1:1994
Symbol No.
417-5017
General grounding
terminal,
including the functional.
IEC60601-1:1994
Symbol nº.
529
Dip proof equipment when inclinated up to
15º and protected against solid particles
of > 12.5mm diameter P
EN 980:2003
Symbol No.
5.8
Consult Operating Instructions
IEC60601-1:1994
Symbol No.
348
Warning! Consult
ATTACHED DOCUMENTS
IEC60601-1:1994
Symbol nº.
417-5265
Off, only for
a part of the equipment
IEC60601-1:1994
Symbol nº.
417-5264
On, only for
a part of the equipment
IEC60601-1:1994
Symbol nº.
878-02-02
Equipment with
applied part of Type B
IEC60601-1:1994
Symbol No.
878-03-01
INTERMED®
Inter® NEO
Hazardous voltage
Operation Manual code 806.00260 Rev. 07
96 - Attachment B: Symbols and Terminology
2.The meaning of standard symbols, printed on the equipment
package, is given below:
Symbol
INTERMED®
Inter® NEO
Standard
Description
ISO 780:1997(E)
Symbol
No. 1
FRAGILE: The package’s content
is fragile and should therefore
be handled with care.
ISO 780:1997(E)
Symbol
No. 3
THIS SIDE UP: Indicates the
position of the top of package.
ISO 780:1997(E)
Symbol
No. 4
PROTECT FROM SUNLIGHT:
The package should be kept away
from sunlight.
ISO 780:1997(E)
Symbol
No. 6
PROTECT FROM RAIN:
The package should be kept away
from rain.
ISO 780:1997(E)
Symbol
No. 14
MAXIMUM STACKING: Indicates the
maximum number of identical packages
that may be stacked.
ISO 780:1997(E)
Symbol
No. 17
TEMPERATURE LIMIT: Indicates the
limit temperature for
storage and handling the
package as cargo in
transportation.
ISO 7000:1989
(E/F)
Symbol No. 0505
RELATIVE HUMIDITY: Indicates the
relative humidity for
storage and handling the
package as cargo in
transportation.
Operation Manual code 806.00260 Rev. 07
Attachment B: Symbols and Terminology - 97
Symbol
Standard
BS EN 980:2003
Symbol No. 4.6
MANUFACTURING DATE:
Indicates the date when the
equipment was manufactured.
BS EN 980:2003
Symbol No. 5.2
MANUFACTURER:
Indicates the equipment
manufacturer.
BS EN 980:2003
Symbol No. 5.3
LEGAL REPRESENTATIVE:
Authorized Representative in
the European Community
CE COMPLIANCE MARK
INTERMED®
Inter® NEO
Description
CE COMPLIANCE:
Indicates that the system complies with
the European Council Directive 93/42/EEC
for Medical Equipment. The “xxxx” is the
certification number of the Certifier
Agency used by the manufacturer’s
Quality Sytem.
Operation Manual code 806.00260 Rev. 07
98 - Attachment B: Symbols and Terminology
TERMINOLOGY
The main terms used in this manual, defined by NBR IEC 606011:1994 standard and 1997 amendment and EN 60601-1:1990/
A1:1993/A2:1995, are given below:
1 - ATTACHED DOCUMENTS
Documents attached to the equipment or an accessory, that contain
all important information for the user, operator, installer or
assembler of the equipment, mainly related to safety.
2 - CLASS I EQUIPMENT
Equipment in which the protection against electric shock is not
based only on basic insulation, but also incorporates an additional
safety precaution consisting of a feature for connecting the
equipment to the grounding conductor, for protection of the
installation’s fixed wiring, so as to prevent voltage in accessible
metallic components on occurrence of failure in the basic insulation.
3 - TYPE B APPLIED COMPONENTS
Component applied according to instructions specified in NBR IEC
60601-1:1994 standard and amendment of 1997 to provide
protection against electric shock, mainly with respect to allowable
leakage current and marked by the 878-02-02 symbol (NBR
IEC60601-1:1994).
4 - PROTECTIVE GROUNDING TERMINAL
Terminal connected to conductive parts of a class I equipment for
safety purposes, and planned to be connected to an external
protective grounding system, by means of a protective grounding
conductor.
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
5 Reg. Valve
120 kPa
9 AntiAsphyxia
Valve
11 Insp.
Exhalatioin
Valve
15
Unidirectional
Valve
Inter® NEO
Patient
Circuit
6 Pressure
Sensor
120 kPa
1 Valve % O2
8 AntiAsphyxia
Pilot Valve
10
Exhalation
Pilot
Valve
17 Flow
Sensor
12 Exp.
Exhalation
Valve
19 Cleaning
Valve
18 Auto
Zero
Valve
16
Nebulizer
Valve
Attachment C: Pneumatic Diagram - 99
Operation Manual code 806.00260 Rev. 07
13 Pilot 14 Proximal
Pressure Pressure
Sensor
Sensor
Attachment C: Pneumatic Diagram
INTERMED®
7 Flow Valve
2 Inlet Filter
100 - Attachment C: Pneumatic Diagram
INTERMED®
Inter® NEO
Operation Manual code 806.00260 Rev. 07
Intermed Equipamento Médico Hospitalar Ltda.
Rua Santa Mônica, 980
Cotia - SP - Brazil - CEP 06715-865
After Sales: +55 (11) 5670 1300 - +55 (11) 4615 9300
Sales Center: +55 (11) 5112 1300 - +55 (11) 4615 9300
Fax: +55 (11) 4615 9310
Web site: www.intermed.com.br
E-mail: contato@intermed.com.br
Suggestions, doubts or claims:
After Sales:
0800 770 3357 or visit our web site.
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