Environment; Maintenance; Alarms And Safety Devices; Symbols/Abbreviations - Taema OPTI-NO Manuel D'utilisation

Taema OPTI-NO
aqueous alcohol solution
type), then wipe with a damp cloth.
Leave to dry before plugging into the mains.
The surfaces of the assembly (unit + pressure
regulator) are to be disinfected with a
®
spray (Amphospray 41 type) (scrupulously respecting
the manufacturer's instructions for the dosage of the
product in particular) or with wipes impregnated with
an alcohol based disinfectant solution.
Change filters and tubes for each new patient.

5. Environment

Do not use the OPTI-NO in a specifically magnetic
environment (MRI, etc.).
This device complies with the 93/42/CEE European
directive concerning medical devices, which includes
electro-magnetic compatibility, but its operation may
be affected by other devices being used close by,
such as diathermy and electro-surgical equipment,
defibrillators, short wave therapy equipment and
mobile telephones,
electromagnetic interferences which exceed the levels
specified by the EN 60601-1-2 standard.
In the aim of preserving the environment, all devices
must be disposed of by means of the appropriate
waste disposal methods.
Furthermore, as part of the traceability imposed by
the marking, it is mandatory that the Taema
technical department be informed of the serial number
of the device eliminated.

6. Maintenance

By the user:
For each patient, change the filter, pipe and connector
on the two arms (NO injection and inspiration
detection).
By the approved technician:
At least once a year, a check of the operation and
performances of the device must be carried out.
The regulator must be serviced every 5 years. Re-
place it every 10 years.
The technical maintenance manual is available upon
request to technical personnel authorised to repair
this equipment.

7. Alarms and safety devices

Pneumatic safety devices:
• mechanical safety valves
regulator (9 bar for the low pressure stage and 16 bar
for the high pressure stage).
code YL013700
II. USEFUL INFORMATION
marked (Surfanios
marked
and more generally
fitted to the pressure
Version 3.0 12/2001.
• the device is protected by a
®
injection connector (included in the OPTI-NO kits,
ref. KB010600 and KB010500).
Alarms:
• electrical fault: all of the LEDs are extinguished
and the audible alarm sounds continuously.
(minimal duration : 2 minutes).
• low (bottle empty) or high (setting error) pres-
sure varies (± 20 %) from that set on the unit: flashing
red LED accompanied by a beep. This alarm is set on
the front panel of the device by means of the encoder
wheel ("pressure").
• apnoea of the patient or the inspiration detection
arm is not connected correctly
red LED lit and audible alarm sounds constantly.

8. Symbols/abbreviations

: Type B apparatus
: Caution, refer to the accompanying
documents
0459
: Complies with the 93/42/CEE European
directive issued by the notified body
n° 0459.
IPX1
: Protection index against the penetration
of solids and liquids (protected against
drops of water falling vertically)
~ : Alternating current.
: Direct current.
: Do not remove the pressure regulator
Taema
OPTI - NO
from the OPTI-NO casing.

9. Standards and regulations

- EN 60601-1 (1995 edition): Safety of electro-medical
machines.
- EN 60601-1-2 (1993 edition): Electromagnetic
compatibility of electro-medical machines.
- 93/42/CEE European directive concerning
electro-medical machines.
GB
filter fitted onto the NO
(in sequential mode):
7