Venner PneuX TSM 903200 User manual

Venner Medical (Singapore) Pte Ltd
35 Joo Koon Circle, Singapore 629110
www.vennermedical.com
Advena Ltd
Tower Business Centre, 2nd Flr.,
Tower Street, Swatar, BKR 4013 Malta
www.advenamedical.com
en INSTRUCTIONS FOR USE
de BEDIENUNGSANLEITUNG
es INSTRUCCIONES DE USO
pt INSTRUÇÕES DE UTILIZAÇÃO
Venner PneuX TSM™ Cuff Pressure Controller
Venner PneuX™ Extension Tube

3Venner PneuX TSM™ Cuff Pressure Controller and Extension Tube IFU2
Contents
1. Device description 4
1.1 Venner PneuX TSM™ Cuff Pressure Controller 4
1.2 Venner PneuX™ Extension Tube 4
1.3 Technical specifications 5
2. Operating instructions 5
2.1 Preparation for use 5
2.2 Using the device 5
2.3 During use 5
2.4 Disconnection 6
2.5 Shut down 6
3. Alarms, buttons and indicators 6
4. Decontamination 7
5. Service and maintenance 8
5.1 General maintenance 8
5.2 Preventive maintenance 8
6. Warnings and precautions 8
7. Warranty 8
8. Symbols used on labelling 9
9. Technical information 9
These instructions for use are for the following Venner PneuX™ products:
Product code Description Quantity/box
903200 Venner PneuX TSM™ Cuff Pressure Controller 1
903010 Venner PneuX™ Extension Tube (clean, non-sterile) 10
Only Venner PneuX™ ETT and TT are to be used with the Venner PneuX TSM™ Cuff Pressure Controller and Venner
PneuX™ Extension Tube.

5Venner PneuX TSM™ Cuff Pressure Controller and Extension Tube IFU4
1. Device description
1.1 Venner PneuX TSM™ Cuff Pressure Controller
The Venner PneuX TSM™ ( Figures 1a and 1b ) is an
automated cuff pressure controller designed to be used
with the Venner PneuX™ Endotracheal Tube (ETT) and
Tracheostomy Tube (TT) as a complete system.
It is designed for the monitoring, maintenance and
regulation of pressure within the cuffs of the Venner
PneuX™ ETT/TT in adult patients requiring tracheal
intubation for extended periods (not more than 30 days).
It should be used in medical institutions such as
hospitals and extended care facilities by trained
medical professionals.
The Venner PneuX TSM
™ Cuff Pressure Controller has
an attached Mains charger, audible alarms, LED light
indicators and function buttons (refer to Section 3:
Alarms, Buttons and Indicators). It is supplied with four
international plug adapters (Figure 1c), a pole clamp
and two long screws (5 mm x 14 mm) for mounting
purposes if required.
1.2 Venner PneuX™ Extension Tube
The 2-metre single use Venner PneuX
™ Extension Tube
(Figure 2) connects the Venner PneuX TSM
™ with the
Venner PneuX
™ ETT/TT. One end of the tube is a
uniquely designed Luer lock connector for attachment to
the Connector outlet on the Venner PneuX TSM
™ and
the other end is a Luer slip connector which has a
protective sleeve impeding connection to Luer lock
devices for attachment to the pilot valve of the Venner
PneuX
™ ETT/TT.
The Luer lock connector incorporates several features:
• A twist-to-connect one way valve prevents accidental
disconnection with the Venner PneuX TSM™
• Free coupling rotation avoids the potential of tube
kinking
• Turning latch clicks when connected prevents
damage from over torquing
1.3 Technical specifications
Venner PneuX TSM™
Size 1.4 kg (device)
2.0 kg (in box)
Weight 220 x 110 x 115 mm (device)
300 x 285 x 130 mm (in box)
Power input 100-240 V /50-60 Hz / 400 mA
Power output 15V / 1.0A
Power supply Friwo (model: FW7555/15)
Ingress protection IP33
2. Operating instructions
The Venner PneuX TSM™ is calibrated to be accurate
within +/- 5% of the setting.
CAUTION: All alarms and indicators may have false
positive and false negative errors and should not be
regarded as a substitute for the continuous attention
of a skilled professional.
2.1 Preparation for use
Prior to using the Venner PneuX TSM™, ensure the
patient is intubated with a Venner PneuX™ ETT/TT with
the cuff inflated to a clinical seal. The unique
characteristics of the Venner PneuX™ ETT/TT cuffs
ensure that a low and consistent intracuff pressure is
transmitted to the tracheal wall. An intracuff pressure of
80 cmH2O provides a calculated tracheal wall seal
pressure of approx. 30 cmH2O (~20 mmHg) depending
on the patient’s trachea anatomy and the ventilation
pressures. For details, refer to the Venner PneuX™
ETT/TT IFU.
CAUTION: Due to varying patient anatomies,
requirements for different ventilation pressures and
the Venner PneuX TSM™ accuracy to be within +/-5%
of setting, a clinical seal may be achieved between
80-90 cmH2O.
Position Venner PneuX TSM™ on a suitable flat surface
or on a drip pole. For attachment to a drip pole pierce
through the two target points on the Pole-Mount area
(Figure1b:L) of the device. Attach the clamp to the
device using the long screws provided and thereafter,
secure tightly to the drip pole.
2.2 Using the device
Attach the appropriate international plug adapter
(Figure 1c) to the Mains charger by sliding its vertical
slots through the bottom of the Mains charger
(Figure 1b). Begin operating the Venner PneuX TSM
™
by connecting the Mains charger to a power outlet and
observe a GREEN light appearing on the Mains charger
indicator (Figure 1b:M) to confirm there is power supply.
A RED light from the Standby Power indicator (Figure 1a:I)
should also illuminate. If no light appears on either
indicators, check the connection.
Proceed to attach the Luer lock connector (Figure 2:N)
of the Venner PneuX™ Extension Tube to the Connector
outlet (Figure 1a:A) on the Venner PneuX TSM™, and the
Luer slip connector (Figure 2:O) to the pilot valve of the
ETT/TT. Ensure that there is no accidental pulling or
tugging of the Extension Tube.
Switch on the Venner PneuX TSM
™ by pressing the
Power On/Off button (Figure 1a:G). All LED indicator
lights will flash rapidly five times before adjusting to
the default seal pressure illuminated by the Target Seal
Pressure indicator (Figure 1a:D). The default seal
pressure setting is 20 mmHg (approx. 30 cmH2O) unless
a user change this using the Target Seal Pressure
Selector Keys (Figure 1a:E). During normal operation, all
3 lights (Mains Power indicator (Figure 1a:F), Target Seal
Pressure indicator and Seal Pressure Attained indicator
(Figure 1a:J) will illuminate at all times.
CAUTION: Should any of the three lights not
illuminate, press the Alarm Reset button (Figure 1a:B)
to reset Venner PneuX TSM™. If this does not work, do
not use the Venner PneuX TSM™ and disconnect the
Extension Tube (refer to Section 2.4: Disconnection).
Contact the local distributor for technical support.
2.3 During use
Cuff pressure changes
An increase or decrease in cuff pressure can occur
due to trans-cuff diffusion of gases, or changes in:
• Tracheal compliance
• Location of the cuff within the airway
• The ventilator/patient interactions
The Venner PneuX TSM™ regulates the ETT/TT cuff
pressure, thereby minimising the risk of complications
associated with excessive pressure (necroses) or
inadequate pressure (aspiration pneumonia) exerted
on the tracheal wall.
Patient transfer
The Venner PneuX TSM™ must be disconnected before
moving patients for operative procedures, scans or during
transfer to other departments/hospitals (refer to Section
2.4: Disconnection).
Australia/China
International plug adapters
Mains charger
Rear view
UK Europe/
South America North America/ Japan/China
Pole-Mount area
Mains charger indicator
M
L
Australia/China
International plug adapters
Mains charger
Rear view
UK Europe/
South America North America/ Japan/China
Pole-Mount area
Mains charger indicator
M
L
Luer lock connector
Luer slip connector
O
N
Figure 1c: International plug adapters for
attachment to the Mains charger
Figure 1b: Venner PneuX TSM™
Front view
Bottom view
Connector outlet (with the
Venner PneuX™ Extension Tube)
Alarm Reset button
Leak/Malposition/Blockage
alarm indicators
Target Seal Pressure indicator
Target Seal Pressure
selector keys
B
A
C
D
E
F
G
H
I
J
K
Mains Power indicator
Power On/Off button
Fault indicator
Standby Power indicator
Seal Pressure Attained
indicator
Ventilation slots
Figure 1a: Venner PneuX TSM™ Figure 2: Venner PneuX™ Extension Tube

7Venner PneuX TSM™ Cuff Pressure Controller and Extension Tube IFU6
Should this occur, disconnect the system (refer to
Section 2.4: Disconnection) and deflate the cuff for
re-intubation using a cuff manometer. Proceed to
reconnect a new Venner PneuX™ ETT/TT to the
Venner PneuX TSM™ (refer to Section 2: Operating
instructions).
CAUTION: A malposition false alarm is possible
if a patient is coughing excessively or experiencing
laboured breathing.
Blockage alarm indicator
This alarm indicator will illuminate RED and produce an
audible alarm if the standard cyclical pressure variability
associated with mechanical ventilation is lost. This may
suggest:
• An occlusion with the Extension Tube or ETT/TT
inflation line. Check to confirm and if so, disconnect
the system (refer to Section 2.4: Disconnection) and
replace with a new Extension Tube or ETT/TT for
reconnection with the Venner PneuX TSM™ (refer to
Section 2: Operating instructions).
• An occlusion with the inflation lumen within the
airway tube due to external compression, e.g.,
an overtightened lock nut or external tie around the
ETT/TT. If so, loosen the lock nut or tie to correct this.
• A blockage of the airway lumen possibly with
secretions, causing the cyclical cuff pressure
changes to be lost. Confirm by other clinical
observations and if so, re-intubate the patient or use
standard techniques to re-establish a patent airway.
CAUTION: A blockage false alarm is possible if the
patient is breathing very gently.
Target Seal Pressure indicator (Figure 1a:D)
This indicator illuminates GREEN next to the seal
pressure being set: 10, 20, 30, 40 or 50 mmHg.
The default seal pressure setting is 20 mmHg (approx.
30 cmH2O) and should not be changed unless
necessary following clinical review. Use the Target Seal
Pressure Selector Keys to change and set the required
seal pressure.
The following situations may require an increase in
seal pressure above 20 mmHg (approx. 30 cmH2O)
temporarily:
• Patients with high intrathoracic pressures who have
a translaryngeal air leak with ventilation (particularly
with high PEEP and peak pressure requirements).
If increased seal pressure is required to prevent a
translaryngeal air leak, check the cuff position for
unintentional carinal or laryngeal placement.
• Patients with abnormal tracheal anatomy
• Patients intubated with an incorrect (smaller)
ETT/TT size (normally size 8.0 mm for a female
and size 9.0 mm for a male)
• A volume recruitment manoeuvre which requires
greater sustained intrathoracic pressure to prevent
a translaryngeal air leak past the cuff (some clinicians
may choose to allow an air leak during recruitment
manoeuvre to create a “PEEP purge” and propel
residual upper airway secretions into the oral cavity
for removal)
• To introduce fluid into the subglottic space at a higher
pressure in order to perform subglottic irrigation
CAUTION: If the seal pressure is set to 40 or
50 mmHg for more than three minutes, its indicator
will flash to visually alert users that the current seal
pressure is higher than normal.
Target Seal Pressure Selector Keys (Figure 1a:E)
The (+) and (-) selector keys allow users to move up
or down to select the five levels of seal pressure setting.
Mains Power indicator (Figure 1a:F)
This indicator illuminates GREEN when the device
is switched on and working normally.
Power On/Off button (Figure 1a:G)
This button switches the device on or off.
Fault indicator (Figure 1a:H)
This indicator illuminates RED when the device detects
an internal fault. Other display lights may show at the
same time. Should this happen, do not use the device
and contact the local distributor for technical support.
Standby Power indicator (Figure 1a:I)
This indicator illuminates RED when the device is on
standby mode for power on.
Seal Pressure Attained indicator (Figure 1a:J)
This indicator illuminates GREEN after the set seal
pressure has been achieved. It normally illuminates
alongside the Target Seal Pressure indicator and Mains
Power indicator during normal operations.
Mains charger indicator (Figure 1b:M)
This indicator illuminates GREEN when there is power
supply to the Venner PneuX TSM™ once connected
to a power outlet.
4. Decontamination
The Venner PneuX TSM™ must be cleaned and
disinfected before first use and between each patient
use, in accordance with local cleaning regime for
non-autoclavable, non-metallic devices.
Visit www.VennerPneuX.com/IFU for a list of
recommended cleaners and disinfectants.
All Venner PneuX™ ETT/TT and Extension Tube are
single use, they should be disposed of in accordance
with standard departmental practices after use.
Overpressure safety (audible “clicks”)
Should the tracheal wall seal pressure exceed 57 mmHg ,
a safety valve will audibly “click” open and vent the
excess pressure. It will subsequently reset itself with a
second “click”, at 27 mmHg for safe operation. The first
and second “clicks” may be simultaneous and be heard
as a double click.
CAUTION: If persistent clicking of the safety valve is
heard for any reasons other than a user setup error or
substantial patient movement, then there may be a
fault with the Venner PneuX TSM™. Contact the local
distributor for technical support.
ETT/TT pilot valve failure
In the event of a failed pilot valve, the Venner PneuX TSM™
may not be able to maintain an effective seal. Perform
re-intubation with a new Venner PneuX™ ETT/TT as
soon as the clinical circumstance allows.
2.4 Disconnection
Prior to disconnection, perform subglottic secretion
drainage to clear the subglottic space. If required,
proceed to disconnect the ETT/TT from the Luer slip
connector of the Extension Tube and subsequently,
disconnect the Luer lock connector of the Extension
Tube from the Venner PneuX TSM™.
Cuff pressure should be maintained temporarily (at
hourly intervals) with a standard cuff manometer until
a new Venner PneuX™ ETT/TT is reconnected to
Venner PneuX TSM™.
CAUTION: Note that the intracuff pressure is normally
maintained at 80 cmH20 with the Venner PneuX™ ETT/
TT, this is equivalent to 30 cmH20 when using a cuff
manometer, or 20 mmHg on the Venner PneuX TSM™.
Take care when using a cuff manometer or syringe for
inflation due to the potential for variations in pressure.
Positive End-Expiratory Pressure (PEEP) may provide
additional protection during manual cuff pressure
adjustments if it is indicated and deemed clinically safe.
2.5 Shutdown
Press the Power On/Off button to switch off the Venner
PneuX TSM
™ . Disconnect the system properly (refer to
Section 2.4: Disconnection) before unplugging the
Mains charger from the wall outlet.
Dispose of the Extension Tube as a contaminated item
and clean the Venner PneuX TSM™ following the cleaning
instructions (refer to Section 4: Decontamination).
3. Alarms, buttons and indicators
Alarm Reset button (Figure 1a:B)
When pressed, this button will cancel sounding alarms
for about 1-2 minutes and if no intervention has taken
place during this time, the alarms will re-sound to alert
users for attention.
CAUTION: DO NOT ignore alarms or continuously
press the Alarm Reset button.
Leak, Malposition and Blockage alarm indicators
(Figure 1a:C)
These alarm indicators should be checked and
actioned upon immediately if sounded. DO NOT
ignore alarms and they should not replace the need
for continual patient monitoring.
Leak alarm indicator
This alarm indicator will illuminate RED and produce an
audible alarm when an exceptional air leak is detected.
This may suggest:
• A detachment with the connection. Check both
connections of the ETT/TT pilot valve with the Luer
slip connector of the Extension Tube as well as the
Luer lock connector of the Extension Tube with the
Connector outlet on the Venner PneuX TSM™.
Perform reconnection if required.
• A puncture with the Extension Tube or ETT/TT.
The cuff of the ETT/TT will deflate and an air leak with
patient ventilation may be audible. Should this occur,
disconnect the system (refer to Section 2.4:
Disconnection), remove the damaged Extension Tube
or ETT/TT and inflate the cuff with a cuff manometer.
Proceed to reconnect a new Extension Tube and
ETT/TT to the Venner PneuX TSM™ (refer to
Section 2: Operating instructions).
CAUTION: Note that the Venner PneuX™ ETT/TT will
remain inflated for up to an hour without connecting
to the Venner PneuX TSM™, however, cuff pressure
should still be monitored and maintained (where
necessary) with a cuff manometer.
Malposition alarm indicator
This alarm indicator will illuminate RED and produce
an audible alarm if a sustained and increased air
requirement for cuff inflation is detected. The alarm
will trigger for as long as there is an increased air
requirement (until the cuff is fully inflated within the
larynx or stoma).
If an ETT is in place, the cuff may have moved into the
larynx/pharynx resulting in a partial extubation. If a TT
is in place, there could be a withdrawal into an open
stoma or an accidental extubation.

9Venner PneuX TSM™ Cuff Pressure Controller and Extension Tube IFU8
8. Symbols used on labelling
Caution
VennerPneuX.com/IFU
Consult Instructions for Use (IFU)
Non-sterile
Caution: Federal (USA) law restricts this
device to sale by or on the order of a
physician
Type B: Provides a basic degree of
protection against electric shock as
specified in the standard IEC60601-1.
The applied part typically has direct
earth connection
Direct current
Power On/Off button
Protection of equipment against ingress
of solid foreign objects ≥2.5 mm
diameter. Protection against access to
hazardous parts with a tool, thick wire,
etc. Protection against water falling as a
spray at any angle up to 60° from the
vertical shall have no harmful effect.
5. Service and maintenance
5.1 General maintenance
The Venner PneuX TSM™ should be inspected at
regular intervals for visible signs of external damage.
Any other doubts or faults with the device will require
diagnosis by an authorised service centre, contact the
local distributor for technical support.
5.2 Preventive maintenance
The Venner PneuX TSM™ is recommended to be
serviced every two years.
When returning for servicing, pack the device in its
original product box or wrap the device carefully for
protection. The device should be sent to the authorised
service centre as advised by the local distributor.
6. Warnings and precautions
The Venner PneuX TSM™ must only be used with
the Venner PneuX™ ETT/TT and Venner PneuX™
Extension Tube.
The Venner PneuX™ Extension Tube is a single use
device. Reuse may cause cross-infection, reduce
product reliability and functionality.
The Venner PneuX TSM™ alarms operate in the event
of critical conditions such as over-inflation, sudden
deflation or pressure loss. Do not ignore alarms and
take appropriate actions (refer to Section 3: Alarms,
buttons and indicators).
Do not attempt to control the Venner PneuX TSM™ by
pressing multiple buttons at the same time.
In the unlikely event of a complete power failure, the cuff
pressure will be maintained by the Venner PneuX TSM™
provided there are no system leaks. Restart operations
when power is restored (refer to Section 2: Operating
instructions).
In the unlikely event of any indicators and function
buttons ceasing to operate, such as no light illumination
or non-responsive buttons, disconnect the device (refer
to Section 2.4: Disconnection) and contact the local
distributor for technical support.
7. Warranty
PneuX Life Systems warrants the hardware products to
be free from defects in material and workmanship under
normal use and service. PneuX Life Systems’ obligation
under this warranty is limited to correcting the defect in
the product or any part thereof which is defective in
material or workmanship during the warranty period.
Replacement shall be determined by PneuX Life
Systems wherein such supplies fail to meet applicable
specifications and were purchased directly from PneuX
Life Systems or an PneuX Life Systems authorised party,
for use with Venner PneuX™ products, and provided the
Buyer or Customer has complied with the handling,
storage and shelf life requirements as specified by
PneuX Life Systems. Any attempts to modify or open up
the device will void its warranty automatically. PneuX Life
Systems shall have no responsibility whatsoever for
consumable supplies purchased from any other source.
THE ABOVE WARRANTIES ARE EXCLUSIVE OF, AND
IN LIEU OF, ALL OTHER WARRANTIES, WRITTEN OR
ORAL, EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE. NO IMPLIED STATUTORY WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE SHALL APPLY. PNEUX LIFE
SYSTEMS SHALL NOT BE LIABLE FOR ANY DAMAGES
SUSTAINED BY BUYER ARISING FROM DELAY IN THE
REPLACEMENT OR REPAIR OF PRODUCTS UNDER
THE ABOVE WARRANTY.
Terms and conditions may change without prior notice.
9. Technical information
The Venner PneuX TSM™ should be used and stored between +10°C and +40°C (50°F – 104°F) with relative
humidity between 30% and 75%.This device is not affected by atmospheric pressure changes.
The Venner PneuX TSM™ conforms to the requirements of the electromagnetic compatibility standard for medical
electrical equipment, EN 60601-1-2 and is intended for use in the electromagnetic environment specified below.
Users should ensure that the Venner PneuX TSM™ is used in such an environment.
Electromagnetic emissions
Emissions test Compliance Electromagnetic environment guidance
Radiofrequency (RF)
emissions
CISPR 11
Group 1 Venner PneuX TSM™ uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Venner PneuX TSM™ is suitable for use in all establishments,
including domestic establishments and those directly connected to
the public low voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
+10ºC
+40ºC
Device should be stored and used
between +10°C and +40°C (50°F –
104°F)
Keep dry
Keep away from sunlight
Date of manufacture
Legal manufacturer (EU) and
Manufactured for (US)
EC REP Authorised representative in the
European Community
0086
European Conformity mark Notified
Body: BSI Group (0086)
Fragile, handle with care
Catalogue number
SN Serial number

11Venner PneuX TSM™ Cuff Pressure Controller and Extension Tube IFU10
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Venner PneuX TSM™ is used exceeds the
applicable RF compliance level above, the Venner PneuX TSM™ should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Venner PneuX TSM™.
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
The Venner PneuX TSM™ is intended for use in the electromagnetic environment in which radiated RF disturbances
are controlled. Users of Venner PneuX TSM™ can help to prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the device as
recommended below, according to the maximum output power of the communication equipment.
Recommended separation distances between portable and mobile RF communications equipment
Rated maximum output
power of transmitter (m)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 1.2√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
STATEMENT: Venner PneuX TSM™ is classed as Medical Electrical Equipment that requires special precautions
to be taken regarding EMC, and needs to be installed and put into service according to the electromagnetic
compatibility information provided in the accompanying documents.
Electromagnetic immunity
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Venner PneuX TSM™ uses RF energy only
for its internal functions. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 2 kV for power supply
lines
There is no input/output
line
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
There is no connection
to earth
Mains power quality should be
that of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
I
EC 61000-4-11
<5% UT (>95% dip in
UT) for 0.5 cycles
40% UT (60% dip in
UT) for five cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT
(>95% dip in
UT ) for five seconds
<5% UT
(>95% dip in
UT ) for 0.5 cycles
40% UT (60% dip in UT)
for five cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in
UT ) for five seconds
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of Venner PneuX TSM™ requires
continued operation during mains power
interruptions, it is recommended that
Venner PneuX TSM™ be powered from an
uninterruptible power supply or battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital
environment.
CAUTION: UT is the a.c. mains voltage prior to application of the test level.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz
to 80 MHz
3 V/m
80 MHz
to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of Venner PneuX TSM™, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey a, should be less than the
compliance level in each frequency range b.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

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