General Safety Instructions - Taema OPTI-NO Manuel D'utilisation

Taema OPTI-NO
Handling of high pressure bottles:
• Ensure that the bottle is attached (by a clamping
collar or a sleeve for example) to avoid any risk of it
falling.
• Avoid any unnecessary handling of bottles fitted
with a pressure regulator.
• Open the bottle tap slowly, and always stand beside
the bottle, not in front of it when doing so.
• Carefully close the taps after use and when the
bottles are empty.
• In the event of a leak between the pressure
regulator and the bottle tap:
- Do not tighten the connector when it is pressurised.
- Close the bottle tap and wait until the leak stops
(zero pressure reading on the high pressure
manometer) before removing the pressure regulator.
- Change the seal. Only use original spare parts
supplied by Taema.
Each time before commissioning, carry out the
checks listed in the appendix (page 11).
• Audible alarm:
The audible alarm of the OPTI-NO is intended to be
heard by a practitioner situated close to the patient.
It is not designed to alert another person in a
different room.
The maximum distance must therefore be determined
by the user to suit the environmental conditions.
Use of the NO/N mixture:
2
• Check that the gaseous mixture used complies with
the manufacturer's specifications (e.g. 250 and
500 ppm).

GENERAL SAFETY INSTRUCTIONS ... 1

I. DESCRIPTION AND FITTING ............ 2
1. List of the constituent parts of the system ....... 2
2. Fitting the OPTI-NO onto a bottle .................... 2
3. Flushing the OPTI-NO ..................................... 3
4. Operating modes ............................................. 3
5. Determining the settings .................................. 3
6. Installing the OPTI-NO .................................... 4
7. Setting in continuous mode ............................. 5
8. Setting in sequential mode .............................. 5
II. USEFUL INFORMATION ................... 6
1. Alarms and malfunctions ................................. 6
2. Removing the OPTI-NO from a bottle ............ 6
3. Interruption of the treatment ............................ 6
4. Cleaning - disinfection of the pressure
regulator and OPTI-NO casing ............................ 6
5. Environment .................................................... 7
code YL013700
GENERAL SAFETY INSTRUCTIONS
CONTENTS
Version 3.0 12/2001.
• The NO and N levels in the surrounding atmosphere
2
should also be measured.
The OPTI-NO is a device for supplying injection of
a NO/N mixture flow determined by the user. It is
2
not fitted out with the monitoring of the inhaled
gases by the patient (O
tion, ...). The physician has to judge the timeliness
to use OPTI-NO in conjunction with an additional
monitoring system.
• The OPTI-NO must only be adjusted and used on
prescription and under medical control.
• Only persons who have read and understood
this entire manual are authorised to use the
OPTI-NO .
Use and maintenance of the device
In compliance with the EN 60-601-1 standard
( § 6.8.2. b): «The manufacturer, assembler, installer
or importer are not considered to be responsible
themselves for the consequences on the safety,
reliability and characteristics of a device unless:
- The assembly, fitting, extensions, adjustments,
modifications or repairs have been performed by
persons authorised by the party concerned,
- The electrical installation of the corresponding
premises complies with IEC regulations.
- The device is used in accordance with the instruc-
tions for use.»
If the replacement parts used for the periodic servicing
by an approved technician do not comply with the
manufacturer's specifications, the latter is absolved
from all responsibility in the event of an accident.
6. Maintenance .................................................... 7
7. Alarms and safety devices ............................... 7
8. Symbols/abbreviations ................................... 7
9. Standards and regulations .............................. 7
III. TECHNICAL DATA ........................... 8
1. Technical characteristics .................................. 8
2. Bibliography ..................................................... 8
3. Equations for calculating the reduction
pressure to be used ............................................. 9
4. Materials in contact with the medical gas ...... 10
5. OPTI-NO principle diagram ........................... 10
IV. APPENDICES ................................. 11
Check-list for installation/following maintenance
work ................................................................... 11
Start-up check-list .............................................. 11
Service sheet .................................................... 12
GB
, NO and NO concentra-
2 x
1