Medela Thopaz Instructions For Use Manual

Medela Thopaz Instructions For Use Manual

Thoracic drainage system
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Thopaz
Thoracic Drainage System
Instructions for use
EN
Gebrauchsanweisung
DE
Mode d'emploi
FR
Istruzioni per l'uso
IT
Gebruiksaanwijzing
NL
Bruksanvisning
SV
Brugsanvisning
DA
Instrucciones de uso
ES
Instruções de utilização
PT
Instrukcja obsługi
PL
-10 kPa / 5 L/min

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Summary of Contents for Medela Thopaz

  • Page 1 Thopaz ™ Thoracic Drainage System Instructions for use Gebrauchsanweisung Mode d’emploi Istruzioni per l’uso Gebruiksaanwijzing Bruksanvisning Brugsanvisning Instrucciones de uso -10 kPa / 5 L/min Instruções de utilização Instrukcja obsługi...
  • Page 2 Technical specifications – Technische Daten – Données techniques – Specifiche techniche – Technische specificaties – Tekniska specifikatio- ner – Tekniske specifikationer – Especificaciones técnicas – Especificações técnicas – Specyfikacja techniczna Low vacuum H x W x D - 10 kPa 95 x 170 x 235 mm - 75 mmHg 3.74 x 6.69 x 9.25 inch...
  • Page 3: Intended Use

    • to regain or maintain negative pressure in the intrapleural space and to unfold the lungs. Thopaz is intended for use on patients in all stages of the hospital. The unit should only be operated by properly trained staff. These persons must not be hard of hearing or deaf and must have adequate visual faculty.
  • Page 4: Warnings / Safety Instructions

    Thopaz is approved exclusively for use as described in these instructions. Medela can only guarantee the safe functioning of the system when Thopaz is used in combination with the original Medela accessories (canisters, tubing sets, carrying strap, mains adapter, docking sta- tion).
  • Page 5: Initial Start-Up

    Check the condition of the delivery package and that it is complete. Thopaz™ 079.0000 079.0002 079.0003 Mains adapter Thopaz Thopaz CD 077.0148 Instructions for use 079.0035 200.0685 200.0686 200.2004 Do not switch Thopaz on before first charging the battery! Initial startup 1. Select plug...
  • Page 6 Switch Thopaz off with [ ]. Thopaz is ready for use. If Thopaz was switched on before the battery was fully charged (step 2), follow the instructions on the display. Before the first application in accordance with the intended use, an inspection according to IEC 62353 (see Appendix B) is recommended to acquire the reference values.
  • Page 7 Overview of Thopaz Tubing guide Suction port Display Release button Canister (ill. 0.3 L) USB port Mains adapter port Specification plate Carrying handle Vacuum port with seal Bed holder Standard rail holder Battery charging status Run/Standby indicator Power on/off Information field...
  • Page 8 Disposables Canister with/without solidifier 0.3 L and 0.8 L Material: Polypropylene Reading accuracy: +/- 2.5% (in upright position) Solidifier: 0.3 L = 12 g / 0.8 L = 28 g Overflow protection/ Bacteria filter Pressure relief valve Safety chamber Sealing caps Graduation Secretion chamber Capacity 0.3 L...
  • Page 9: Preparation For Use

    Snap in canister Unpack canister, position the openings at the top and attach the bottom part of the canister to the pump. Push the canister into Thopaz until you hear a click.
  • Page 10 Leak in the system; Flow does not decrease: check tubing connections, replace canister and/or tubing 3. Switch to Standby mode: Press 'Standby' (press for > 3 sec.) 4. Thopaz is in Standby mode and is ready for use with the factory settings.
  • Page 11 Remove the inner packaging from the tubing. Usage 1. Switch on Thopaz with [ ] – self-test starts. Do not switch Thopaz on if the patient is already connected. 2. New patient? yes/no. 3. • Switch on pressure by pressing 'on' – the pre-selected pressure is built up and kept constant.
  • Page 12 Indicator only visible in zoom mode at a flow of 0 mL/min catheter clogged? If Thopaz does not show the respiratory movements, request the patient to breathe slowly and deeply.
  • Page 13 1. Close patient tubing with the tube clamp. 2. Switch off pressure by pressing 'Standby' (press for > 3 sec.) – Thopaz switches to standby mode. 3. Release, remove and seal the canister. 4. Dispose of canister and patient tubing in accordance with internal hospital guidelines.
  • Page 14: Replace Canister

    3. 'Standby' (press for > 3 sec.) Thopaz switches to the Standby mode. 4. Release and remove canister. 5. Unpack new canister, position into Thopaz and snap in (Chapter VII). 6. Press 'on'. Pressure is built up. 7. Open the tube clamp.
  • Page 15: Change Settings

    Change settings The settings may only be changed by the physician or on medical orders. Operating mode Change pressure Press simultaneously a) Press [ ] and [ ] simultaneously. The pressure is indicated on the display. b) With the selection buttons set the desired pressure and confirm with 'OK'. c) To activate the gravity mode press the [ ] button and confirm with 'OK'.
  • Page 16: Data Transfer To Pc

    Display Display Display Set as standard Thopaz is delivered with the following factory settings. These settings can be changed and saved as the new standard and are active whenever Thopaz is switched on. To save the selected settings, confirm pa‑...
  • Page 17 Alarms Thopaz distinguishes between warnings, alarms and errors. If Thopaz detects any of these situations, an acoustic warning signal sounds and a description of the problem appears on the display. By pressing the two selection buttons simultaneously, the acoustic alarm is suppressed for 60 seconds and the troubleshooting instructions appear on the display.
  • Page 18 Temperature too Prepare backup Cool Thopaz (for example with high device a fan, hair dryer, etc.). ✔ Do not expose Thopaz to direct sunlight. Battery empty Charge battery – con- ✘ nect Thopaz to mains System clogged • Check that tubing is •...
  • Page 19: Additional Information

    The warning is reactivated under the following conditions: - if Thopaz is switched off and then on again – for example, on replacing the canister. - if the level sensor is not activated for at least 10 minutes.
  • Page 20: Optional Accessories

    (is delivered without mains (not included in scope of delivery) adapter) Cleaning Thopaz with accessories should be cleaned / disinfected after every use. General notes • The internal hospital guidelines take precedence. • Disconnect Thopaz from the mains before cleaning / disinfection.
  • Page 21 Guarantee XVll Thopaz is guaranteed for 2 years after the date of delivery when used in accordance with these instructions. The manufacturer is not liable for any damage or consequential damage caused by incorrect operation, inappropriate use as well as use by unauthorised persons.
  • Page 22 Article numbers and descriptions 079.0000 Thopaz drainage pump with Instructions for use 200.0685 079.0002 Thopaz drainage pump with Instructions for use 200.0686 079.0003 Thopaz drainage pump with Instructions for use 200.2004 Disposables 079.0011 Thopaz canister 0.3 L 079.0012 Thopaz canister 0.3 L with solidifier 079.0016...
  • Page 23 Graphic presentation 9, 11 Gravity mode 14 Technical documentation 1, 23, 24, 25, 26 Guarantee 20 Thopaz CD 4, 15, 21 Guidelines 3, 12, 13, 19, 20, 25, 26 Tube clamp 7 Tube flushing 18 Tubing set 3, 19, 20, 21, 28...

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