Related Manuals for Fahl TRACHEOFIRST PRO
Summary of Contents for Fahl TRACHEOFIRST PRO
- Page 1 Operating Instructions TRACHEOFIRST ® TRACHEOPORT ® English GA1GB.901710.0 E349855 2023-04 Index 02...
-
Page 2: Table Of Contents
Table of contents Introduction ........... . . 4 Notes on operating instructions . - Page 3 Operation ............27 Switching on the device .
-
Page 4: Introduction
This document may only be reprinted, either in part or in whole, with written permission from Andreas Fahl Medizin- technik-Vertrieb GmbH. These operating instructions must always be kept available near the device. -
Page 5: Explanation Of Pictures And Symbols
1.2 Explanation of pictures and symbols In the operating instructions DANGER Warning of a danger that will result in immediate fatal or serious injury. Observe the necessary measures. WARNING Warning of a danger that can cause fatal or serious injury. Observe the necessary measures. - Page 6 Manufacturer Date of manufacture Country of manufacture Distributor Reference number Unique Device Identifier of a medical device Medical device Serial number Batch code Use-by date Protected against ingress of: IP21 • Solid foreign particles Ø ≥12.5 mm • Dripping water from above Type BF applied part Professional disposal Not for reuse (designed for repeated use for a single patient)
- Page 7 Atmospheric pressure limitation Do not use if the packaging is damaged The packaging configuration of this medical device has been changed by the company Andreas Fahl Medizintechnik-Vertrieb GmbH. UDI application identifier (01) UDI-DI: Identification of the manufacturer and the device...
-
Page 8: Intended Purpose
On the mains power unit Protection class II device Professional disposal This product complies with the relevant requirements of the EU Directives. Devices with this symbol may only be used indoors (dry surroundings) Protected against: IP52 • Dust in harmful quantities •... - Page 9 Patient selection • Patients who benefit from suction of the upper and/or criteria: lower respiratory tracts Indications: In cases of damage to respiratory and coughing functions with dysfunctional elimination of tracheal, bronchial, or oral secretion: • suction after tracheotomy • suction after laryngectomy •...
-
Page 10: Function
1.4 Function General description The devices are mobile, portable medical suction devices designed for temporary, preferably spontaneous suction of the upper and lower respiratory tract. The suction material (including secretion, blood, serous fluids, and food particles) is temporarily collected in a collection canister and then disposed of. Principles of operation and its mode of action The devices are electrically operated and take their medical effect by generating vacuum and suction performance. -
Page 11: Scope Of Delivery
Only transport the device in a shipping carton that is padded and offers sufficient protection. If damage occurs during transport: 1. Document and report the transport damage. 2. Get in touch with your contact person at Andreas Fahl Medizintechnik-Vertrieb GmbH. Ambient conditions for transport and storage: •... -
Page 12: Notes For Your Safety
2.0 Notes for your safety The safety of the TRACHEOFIRST PRO and the TRACHEOPORT PRO complies with the ® ® recognised rules of technology and the guidelines of the Medical Devices Act. 2.1 General safety instructions Report all serious incidents that have occurred in connection with this device to the manufacturer and your national competent authority. - Page 13 • Do not operate the device if it has been dropped. In this case, please clean the device and send it in to Andreas Fahl Medizintechnik-Vertrieb GmbH for repair. • Disconnect the device from the mains power supply prior to cleaning or disinfection.
-
Page 14: Avoiding Damage To The Device
Ensure that no liquid penetrates the device. Once liquid has penetrated the device, it may no longer be operated. In this case, please clean the device and send it in to Andreas Fahl Medizintechnik-Vertrieb GmbH for repair. • Always place the device on firm, level surface. The device must always be in a vertical position when you use it. -
Page 15: Setting Up And Starting Up
3.0 Setting up and starting up Please observe that insufficient battery charge can result in damage to the battery. 1. Fully charge the battery for the TRACHEOPORT PRO before using the device. ® 3.1 Device overview 3.1.1 Front/rear view (with TRACHEOFIRST PRO / TRACHEOPORT ®... -
Page 16: Front/Rear View (With Serres Refitting Set)
3.1.2 Front/rear view (with Serres refitting set) ® Front view Control panel Carry handle Vacuum gauge Vacuum regulator (from - to +) Connection for the mains power unit ... -
Page 17: Control Panel
3.1.3 Control panel TRACHEOFIRST ® On/off button Release button Holder for suction hose Connection for hose adapter Operation status indicator TRACHEOPORT ® On/off button Release button ... -
Page 18: Preparing The Device With The Serres Refitting Set
8. Replace a defective mains power unit immediately. 9. For the TRACHEOPORT PRO: The battery must be fully charged; see chapter “3.4 ® Charging the battery” on page 19. 10. Operate the device only when the bacterial and viral filter is inserted and the TRACHEOFIRST PRO / TRACHEOPORT PRO secretion canister is connected. -
Page 19: Charging The Battery
15. Attach the vacuum connection hose to the bacterial and viral filter and to the angle on the external canister of the disposable system. 16. Attach the disposable suction hose to the suction bag. 3.4 Charging the battery The battery’s charge level is shown by the LED battery charge indicator on the control panel. -
Page 20: Connecting/Removing The Secretion Canister Tracheofirst
3.6 Connecting/removing the secretion canister TRACHEOFIRST PRO / TRACHEOPORT PRO and the ® ® hoses 3.6.1 Connecting the TRACHEOFIRST PRO / TRACHEOPORT ® ® secretion canister WARNING Risk of infection from contaminated bacterial and viral filter as well as canister Deadly diseases can be transmitted. - Page 21 4. Check that the TRACHEOFIRST ® / TRACHEOPORT PRO canister lid is ® tightly closed. 5. Check the white seal on the bacterial and viral filter to see whether it is positioned correctly. If the white seal is missing, replace the bacterial and viral filter.
-
Page 22: Notes On The Bacterial And Viral Filter
3.6.2 Notes on the bacterial and viral filter The bacterial and viral filter is located between the device and the TRACHEOFIRST PRO / TRACHEOPORT ® ® PRO secretion canister. This consists of a hydrophobic bacterial and viral filter with a blue support and white seal. -
Page 23: Connecting The Hose Adapter
3.6.5 Connecting the hose adapter 1. Insert the turquoise hose adapter into the opening on the TRACHEOFIRST ® PRO / TRACHEOPORT PRO canister lid. ® 2. Turn the turquoise hose adapter a quarter turn clockwise. 3. Now, check that the hose adapter is connected firmly to the TRACHEOFIRST ®... -
Page 24: Connection
WARNING Insufficient or no vacuum due to incorrect connection. The patient can suffocate. • Observe the manufacturer’s operating instructions for the Serres canister system. ® 3.7.1 Connection 1. Attach the support for the Serres external canister directly to the device. ®... -
Page 25: Removal
3.7.2 Removal 1. Remove the disposable suction hose from the Serres suction bag. ® 2. Close the “patient” connection on the Serres suction bag with the green cap. ® 3. Remove the vacuum connection hose from the Serres external canister. ®... -
Page 26: Notes On The Bacterial And Viral Filter For The Serres
3.7.3 Notes on the bacterial and viral filter for the Serres refitting ® • The bacterial and viral filter is located between the device and the Serres canister system. ® • This consists of a hydrophobic bacterial and viral filter with a blue support and white seal. •... -
Page 27: Operation
4.0 Operation WARNING Risk of infection due to lack of hygiene or damaged components! Deadly diseases can be transmitted. • Always use new consumables for every patient (TRACHEOFIRST PRO / TRACHE- ® OPORT PRO secretion canister, bacterial and viral filter, hose adapter, and suction ®... -
Page 28: Suction
3. Turn the vacuum regulator to the right until the vacuum gauge shows the desired vacuum. 4. To reduce the desired vacuum, turn the vacuum regulator to the left. The vacuum regulator shows the setting range directly (from - to +). ... -
Page 29: After Use
4.5 After use 1. Switch off the device by pressing the on/off button. 2. Clean the device after each use; see chapter “5.0 Cleaning and disinfection” on page 3. Perform a function check after each cleaning; see chapter “6.1 Function check” on page 36. -
Page 30: Cleaning And Disinfection
5.0 Cleaning and disinfection 5.1 Safety instructions for reprocessing 5.1.1 General safety instructions We recommend that you always document all maintenance work and part replacements in writing. It is the responsibility of the user to ensure that the demands for cleaning and disinfection are adhered to. -
Page 31: Preparing/Completing Reprocessing
Damage to the device due to cleaning with fixatives! Soiling will become permanently unremovable. • Do not use aldehydes before and for cleaning. • Do not expose the product to temperatures above 40 °C / 104 °F before and during cleaning. -
Page 32: Prepare Surfaces
5.3 Prepare surfaces 5.3.1 Overview Surface Remarks Housing incl. carry handle As per agent manufacturer’s instructions Vacuum gauge As per agent manufacturer’s instructions Vacuum regulator As per agent manufacturer’s instructions Release button As per agent manufacturer’s instructions Control panel As per agent manufacturer’s instructions 5.3.2 Selecting process chemicals Observe the process chemical manufacturer’s specifications. -
Page 33: Pre-Cleaning
Agent (manufacturer) Active ingredients in 100 g mikrozid® universal 2-propanol 17.4 % / 100 g Wipes x x x x x wipes (Schülke & Ethanol 12.6 % / 100 g Mayr) Bacillol® AF (Bode Alcohols Solution x x x x x Chemie) Ready for use 5.3.3 Pre-cleaning... -
Page 34: Reprocessing The Accessories
5.4 Reprocessing the accessories 5.4.1 Replacing accessories Accessories TRACHEOFIRST® PRO / TRACHEOPORT® PRO secretion canister Suction hose with fingertip Hose adapter Bacterial and viral filter When the device is to be used on another patient, the bacterial and viral filter, the suction hose, the hose adapter as well as the TRACHEOFIRST®... - Page 35 Suction hose To prevent secretion from drying out, the suction hose must be rinsed with clean water after every suction process. The water from a rinsing canister can be suctioned through the fingertip into the secretion canister by means of the suction device. Please fill the secretion canister only about halfway.
-
Page 36: Maintenance And Service
Periodic tests Comply with the country-specific guidelines regarding regular testing, especially with regard to electrical safety. Andreas Fahl Medizintechnik Vertrieb GmbH recommends performing a test every 24 months in accordance with the Medical Devices Operator Ordinance. 6.1 Function check Perform a function check: •... -
Page 37: Troubleshooting
7.0 Troubleshooting The TRACHEOFIRST PRO or the TRACHEOPORT PRO has been subjected to thorough ® ® quality control in the factory. Nevertheless, if a problem does occur, you can possibly resolve it yourself. Recharging and battery status Error symptom Possible cause Remedy Device cannot be The mains power... - Page 38 Vacuum and suction capacity Error symptom Possible cause Remedy Vacuum is not built Battery is discharged or Charge the battery or send the up or cannot be defective. device in for repair. reached. Hoses or TRACHEOFIRST Check the TRACHEOFIRST PRO / ®...
-
Page 39: Accessories And Consumables
8.0 Accessories and consumables 8.1 Accessories Name Refitting set Serres with external canister for TRACHEOFIRST ® ® 65962 / TRACHEOPORT ® Mains power unit 011.1363.0 8.2 Consumables Name TRACHFLOW LINE PRO 1.3 m 60506 ® TRACHEOFIRST PRO / TRACHEOPORT PRO bacterial and viral filter 60840 ®... -
Page 40: Disposal/Recycling
Do not dispose of devices or batteries in domestic waste. 1. Clean and disinfect the device. 2. In Germany: Send the product back to Andreas Fahl Medizintech- nik-Vertrieb GmbH or your specialist dealer. They will dispose of the device professionally. -
Page 41: Technical Data
10.0 Technical data 10.1 TRACHEOFIRST ® Input voltage 100 – 240 V~ ± 10 %; 50/60 Hz (13,4 VDC mains power unit) Current consumption Max. 1 A Power consumption Max. 37 W Mains power unit Manufacturer: GlobTek, Inc. Model: GTM46402-3713.4 Suction capacity (on pump, during 27 l/min ±... -
Page 42: Tracheoport ® Pro
CE mark ID No. (REF) 67800 TRACHEOFIRST ® * Data may differ depending on elevation above sea level, prevalent air pressure and air temperature. 10.2 TRACHEOPORT ® Voltage 100 - 240 V~ ± 10%; 50/60 Hz (13.4 VDC mains power unit) Current consumption Max. -
Page 43: Bacterial And Viral Filter
Dimensions WxHxD 286 x 243 x 118 mm (with secretion canister) 340 x 253 x 140 mm (with Serres refitting set) ® Weight 3,3 kg (with empty secretion canister) 3,5 kg (with empty Serres refitting set) ® Protection class against electric shock (according to EN 60601-1) Classification of applied parts Application parts type BF... -
Page 44: Notes On Emc
11.0 Notes on EMC Medical electrical equipment is subject to special precautions with regard to EMC and must be installed according to the following EMC notes. Guidance and manufacturer’s declaration – ambient conditions The TRACHEOFIRST PRO and the TRACHEOPORT PRO are suitable for operation in the ®... -
Page 45: Legal Notice
The sale and delivery of all products shall take place exclusively in accordance with the General Terms and Conditions (GTCs) of Andreas Fahl Medizintechnik-Vertrieb GmbH; these can be obtained directly from Andreas Fahl Medizintechnik-Vertrieb GmbH. The manufacturer reserves the right to make product modifications at any time. - Page 46 ATMOS MedizinTechnik GmbH & Co. KG Andreas Fahl Ludwig-Kegel-Str. 16 Medizintechnik-Vertrieb GmbH 79853 Lenzkirch / Germany August-Horch-Str. 4a 51149 Köln - Germany Phone +49 (0) 22 03 / 29 80-0 Fax +49 (0) 22 03 / 29 80-100 vertrieb@fahl.de www.fahl.com...