RESPIRONICS 3468ADU-00 LoFlo CO2 Gas Sampling Cannula Instruction Manual

June 15, 2024
RESPIRONICS

**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

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