Advertisement
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.
8
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.
8. Symbols used on labelling
Caution
Consult Instructions for Use (IFU)
VennerPneuX.com/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.
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
Radiofrequency (RF)
Group 1
emissions
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic Emissions
Class A
IEC 61000-3-2
Voltage fluctuations/flicker
Complies
emissions
IEC 61000-3-3
Venner PneuX TSM™ Cuff Pressure Controller and Extension Tube IFU
Device should be stored and used
+40ºC
between +10°C and +40°C (50°F –
+10ºC
104°F)
Keep dry
Keep away from sunlight
Date of manufacture
Legal manufacturer (EU) and
Manufactured for (US)
Authorised representative in the
EC
REP
European Community
European Conformity mark Notified
Body: BSI Group (0086)
0086
Fragile, handle with care
Catalogue number
Serial number
SN
Electromagnetic environment guidance
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.
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.
9
Advertisement
