RESPIRONICS 3468ADU-00 LoFlo CO2 Gas Sampling Cannula Instruction Manual
- June 15, 2024
- RESPIRONICS
Table of Contents
**RESPIRONICS 3468ADU-00 LoFlo CO2 Gas Sampling Cannula Instruction Manual
**
Accessories – Instructions for Use
Refer to the Instructions for Use accompanying your host monitor for more
information. Also refer to page 2 and 3 for setup diagrams.
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.
Symbols
These symbols may be found on LoFlo accessories, labels, packaging, and other
documentation.
| Do not reuse| | Consult Instructions for Use
---|---|---|---
| Quantity| | This device complies with Regulation (EU) 2017/745
| Storage humidity| | This device complies with Regulation (EU) 2017/745
| Storage temperature| | Adult only
| U.S. Federal law restricts this device to sale by or on the order of a
physician.| | Adult/Pediatric only
| ETT > 4.0mm Deadspace < 6ml Adult Pediatric| | Pediatric only
| ETT ≤ 4.0mm Deadspace < 1ml Infant Neonatal| | Neonatal/Infant only
| Importer| | Medical device
| Electronic instructions for use|
|
MR Unsafe
| Authorised representative for Switzerland|
Cautions
- Single-use products are not designed to be reused. Reuse may cause a risk of cross-contamination, affect the measurement accuracy and/or system performance, or cause a malfunction as a result of the product being physically damaged due to cleaning, disinfection, re sterilization and/or reuse.
- Verify that the sampling cannula, airway adapter, or sampling line is intact and undamaged.
- For cannulas with an O2 connector, verify oxygen flow prior to use.
- Cleaning and sterilization will compromise system performance.
- Remove sample cell from monitoring system when not in use.
- Do not use on patients that cannot tolerate the removal of 50ml/min from their total minute ventilation.
- Do not position cables or tubing in any manner that may cause entanglement or strangulation.
| Accessory – LoFlo | Intended Use/Indications for Use: |
|---|---|
| C O 2 Sampling Annular, Nasal (3468 A D U-00, 3468 PE D-00, 3468 INF-00) | For |
use with the Lo Flo Sidestream C O2 Sensor when monitoring patients that are
not intubated.
CO 2 Sampling Can nula w/ Dehumidification Tubing, Nasal (3468 A D H-00, 3468
PEH-00, 3468 I N H-00)
CO 2 w/O 2 Cann ula, Nasal (3469ADU-00, 3469PED-00, 3469INF-00)
CO2 w/O 2 Cannula w/ Dehumidification Tubing, Nasal (3469ADH-00, 3469PEH-00,
3469INH-00)
CO2 Sampling Cannula, Oral/Nasal (3470ADU-00, 3470PED-00)
CO2 Sampling Cannula w/ Dehumidification Tubing, Oral/Nasal (3470ADH-00,
3470PEH-00)
CO2 w/O2 Cannula, Oral/Nasal (3471ADU-00, 3471PED-00)
CO2 w/O2 Cannula w/ Dehumidification Tubing, Oral/Nasal (3471ADH-00,
3471PEH-00)
Airway Adapter Kit, ETT >4.0mm, Deadspace <6ml (3472ADU-00)| For use with the
LoFlo Sidestream CO2 Sensor when monitoring patients with an endotracheal tube
size larger than 4.0mm.
Airway Adapter Kit w/ Dehumidification Tubing, ETT >4.0mm, Deadspace <6ml
(3473ADU-00)
Airway Adapter Kit, ETT ≤4mm, Deadspace <1ml (3472INF-00)| For use with the
LoFlo Sidestream CO2 Sensor when monitoring patients with an endotracheal tube
size of 4.0mm or smaller.
Airway Adapter Kit w/ Dehumidification Tubing, ETT ≤4mm, Deadspace <1ml
(3473INF-00)
Sampling Line Kit, Male Luer (3474-00)| For use with the LoFlo CO2 Sensor with
ventilator and anaesthesiacircuits that have an integrated airway adapter with
a female Luer- Lok connector.
Sampling Line Kit w/Dehumidification Tubing, Male Luer (3475-00)
Sample Line, Female Luer Connector (3476-00)| For adapting CapnoTrak
accessories for use with a LoFlo Module.
Disposal
Dispose of in accordance with all applicable federal, state, and local medical
/ hazardous waste practices.
Respiration Econometric , L L C
3000 Minuteman Rd.
And over, MA 01810 USA
Respironics Deutschland GmbH & Co. KG
Gewerbestrasse 17
82211 Herrsching
Germany
+49 8152 93060
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684PC, Best
The Netherlands
Australian Sponsor
Philips Electronics Australia Ltd
65 Epping Road
North Ryde, NSW Australia 2113