Respironics 6063-00 Instrucciones De Uso

Airway Adapters - Instructions for Use
Refer to the Instructions for Use accompanying your host monitor.
Note: Sterilization will likely compromise system performance.
Symbols
These symbols may be found on airway adapter labels, packaging, and other documentation.
Pediatric/Adult only
Neonatal/Pediatric only
Consult Instructions for Use
Quantity
Importer
Part number Description
Pediatric/Adult
6063-00 Airway Adapter,
Single use
Neonatal/Pediatric
6312-00 Airway Adapter,
Single use
Pediatric/Adult
Airway Adapter with
6421-00
Mouthpiece,
Single use
Disposal
Dispose of in accordance with all applicable federal, state, and local medical / hazardous waste practices.
NOTE: Any serious incident that has occurred in relation to this device should be reported to Respironics Novametrix and the competent authority of the country in which the user
and/or patient is established.
Respironics Novametrix, LLC
3000 Minuteman Rd.
Andover, MA 01810 USA
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684PC, Best
The Netherlands
This device complies with Regulation (EU) 2017/745
U.S. Federal law restricts this device to sale by or on the
order of a physician.
Electronic instructions for use
Medical device
Authorised representative for Switzerland
Intended Use/Indications for Use
For monitoring Pediatric/Adult patients with
endotracheal tube size greater than 4.0mm
with the CAPNOSTAT CO sensor.
2
For monitoring Neonatal/Pediatric patients
with endotracheal tube size of 4.0mm or
smaller with the CAPNOSTAT CO
For spot-checking non-intubated adult or
appropriate size pediatric patients with the
CAPNOSTAT CO Sensor.
2
Instructions for Use
1. Verify the adapter is intact. Press the CAPNOSTAT CO
It will "click" into place when properly seated.
2. Perform an Airway Zero only if prompted by the monitor (see User's Manual for details).
3. Install at the proximal end of the circuit between the elbow and the ventilator wye. If using
an HME, place adapter between HME and wye. The cord of the CAPNOSTAT CO
should be facing away from the patient. For optimal results, DO NOT place the adapter
between the ET tube and the elbow.
sensor.
2
4. Ensure the integrity of the patient breathing circuit after insertion of the airway adapter.
1. Verify the adapter is intact. Check that the mouthpiece is securely fastened to the
adapter. Press the CAPNOSTAT CO
place when properly seated.
2. Perform an Airway Zero only if prompted by the monitor (see User's Manual for details).
3. The CAPNOSTAT CO
should seal mouth completely around mouthpiece, then breathe normally.
Respironics Deutschland GmbH & Co. KG
Gewerbestrasse 17
82211 Herrsching
Germany
+49 8152 93060
Australian Sponsor
Philips Electronics Australia Ltd
65 Epping Road
North Ryde, NSW Australia 2113
Storage humidity
Storage temperature
Do not reuse
MR Unsafe
2
sensor onto the airway adapter. It will "click" into
2
sensor cable should face away from the mouthpiece. Patient
2
EN
English
sensor onto the airway adapter.
sensor
2
15-Aug-2023
1140047AWverE