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– 27 –

Wir / 

We

name und Adresse der firma / 

Baldus Medizintechnik Gmbh 

Name and address of manufacturer:

 

Auf dem Schafstall 5  ·  56182 Urbar – Germany

 

 

+49 (0) 261 / 96 38 926 - 0

  

  +49 (0) 261 / 96 38 926 - 22

  

 [email protected] 

  

www.baldus-medizintechnik.de

erklären in alleiniger Verantwortung, dass / 

declare on our own responsibility that: 

the medical device:

 

Baldus® touch 50/60/70 0

2

-n

2

0 Mixer for analgesia  

 

Baldus® Bag t

Seriennummer / 

serial-number: 

siehe Aufkleber auf dem Medizinprodukt / see lable

allen anwendbaren Anforderungen der richtlinie 93/42/eWG, Anhang II entspricht. / 

meets all applicable requirements of the Directive 93/42/EEC Annex II.

Name, Adresse und Kennnummer 

mdc medical device Gmbh 

der Benannten Stelle / 

Kriegerstraße 6   ·  70191 Stuttgart 

Name address and identification 

0483

 

number of Notified body:

 

Konformitätsbewertungsverfahren / 

Conformity assessment procedure:

Anhang II. / Annex II. 
Klasse IIb (MPg) / class IIb (german Medicinal Devices Act) 

Gültigkeitsdauer / 

validity

 

ort, Datum / 

place, date

 

rechtsverbindliche Unterschrift / 

legally binding signature

 

name und funktion / 

name and function

Lisa Baldus, qM Officer

17/12/2020

Urbar, 01/06/2017

10. DEcLARATION OF cONFORMITY

Summary of Contents for Touch 50

Page 1: ...0483 Made in Germany Instructions for use 02 N2 0 Mixer for Analgesia Baldus Touch 50 60 70 Baldus Bag T...

Page 2: ...sedation and medical gases Welcome to Baldus Medizintechnik GmbH Baldus Medizintechnik GmbH Auf dem Schafstall 5 56182 Urbar Germany 49 0 261 96 38 926 0 49 0 261 96 38 926 21 office baldus medizintec...

Page 3: ...g T 11 3 5 Back and side views 11 3 6 Technical specifications 13 4 Scope of delivery and accessories 14 5 Assembly instructions 15 6 Safety and regular controls 18 6 1 General safety instructions 18...

Page 4: ...ed 01 06 2017 0483 Inhalt nicht steril Contents not sterile Physicians using nitrous oxide have given our service a 1 1 4 rating You can trust the specialist in medical gases and inhalation sedation s...

Page 5: ...and con sult your instruction manual and or contact your ser vice partner or the manufacturer Baldus Medizintechnik GmbH 0049 261 96 38 926 0 Do not attempt to per form any repairs yourself or adjust...

Page 6: ...are facilities Take the table under Section 6 on reduc ing ambient air pollution through nitrous oxide into ac count A suction unit is compulsory and should have a suction power of at least 45 l min I...

Page 7: ...effects The general side effects of nitrous oxide are very minor e g vitamin B12 deficiency In case of continuous admin istration over two days Cardiovascular side effects No relevant side effects fr...

Page 8: ...te When creating a medical history please follow the content of the advanced training course Oxygen nitrous oxide mixer Controls and regulates the flow gas flow rate and per centage nitrous gas and ox...

Page 9: ...switched at any time 3 2 Main menu 1 Start sedation with patient ID A menu with letters and numbers appears for adding a patient by name or patient number After clicking Enter the sedation starts imm...

Page 10: ...last 20 error messages of the unit can be viewed and saved The memory can also be deleted All errors are displayed in the maintenance menu 4 7 Recovery time The recovery time can be set here individu...

Page 11: ...eathe in pure oxygen using the full face mask The demand valve of the mask opens on inhalation If a patient is unconscious and no longer breathing independently he can be actively ventilated by pressi...

Page 12: ...ormat FAT32 Possible sizes of up to 64 GB Fig 7 Baldus Touch view of the left side Fig 8 The full Baldus Touch system in the Baldus All in One Cart BACK FRONT All in One Cart N2 O pressure hose O2 pre...

Page 13: ...ation 0 Maximum N2 O concentration 60 Product variant 3 Baldus Touch 50 for installation Minimum O2 concentration 50 Maximum O2 concentration 100 Minimum N2 O concentration 0 Maximum N2 O concentratio...

Page 14: ...cer 16038 1 O2 Pressure Hose 16038 2 N2 O Pressure Hose 15015 3L or 15015 2 3L 3 L Breathing Bag for Adults or 2 3 L Breathing Bag for Children 15016 Baldus Holder for Cylinders e g cylinder trolley 1...

Page 15: ...keep a spare oxygen cylinder on hand For a centralised gas supply the gas cylinders and equip ment are located in a separate room and the gas flows to the treatment rooms through medical copper pipes...

Page 16: ...e used for this As the connectors are different sizes there is no possibility of confusion Assembling the Baldus Touch mixer and Baldus Bag T The Baldus Touch oxygen nitrous oxide mixer is in stalled...

Page 17: ...here 2 2 Now go from the point for the nozzle out 15 mm to the right and 15 mm upwards and draw the second point for the screws there 2 3 Now go from the point for the nozzle out 15 mm to the right an...

Page 18: ...ns and the Or dinance on Hazardous Substances Gefahrstoffverord nung The gas types must be checked after installing the mixer and accessories to rule out any mix up in the gas types To check the gas t...

Page 19: ...tage administer 100 oxygen to your patient to discontinue the nitrous oxide sedation and start the recovery phase If you do not have any ox ygen supply due to the power outage remove the mask from the...

Page 20: ...ow or there is a measure ment section failure The visual Check O2 signal appears in the top right of the sedation display and the O2 bar on the bottom right is shaded red A Check O2 gas supply pop up...

Page 21: ...an cause malfunctions Have annual safety checks and maintenance per formed including filter checks Service staff employees or partners of Baldus Mediz intechnik GmbH can use a service USB stick to acc...

Page 22: ...Leakscanbeeasilycheckedforusingaspecialleakdetec tion spray which is sprayed on all screw joints and con nections on the mixer and pressure reducers The leak detection spray consists of soap and wate...

Page 23: ...rs 5 Now close the oxygen cylinder 6 The Check O2 information signal appears after a short period of time 7 The system is vented Both pressure reducers now show 0 bar 8 You can now switch off the unit...

Page 24: ...n der is changed and at least monthly Close the gas cylinders completely there should be no appreciable drop in pressure for an hour Always open the high pressure valves of the gas cylinder s slowly O...

Page 25: ...the left concentration controller to add nitrous oxide to the mix as learned in the advanced training course Titrate the nitrous oxide individually for each patient To end the nitrous oxide sedation p...

Page 26: ...ople used to be administered a 100 dose of nitrous oxide at carnivals for fun after which they would stagger around the place comically This would make onlookers laugh j Can I sedate a patient with a...

Page 27: ...lable allen anwendbaren Anforderungen der Richtlinie 93 42 EWG Anhang II entspricht meets all applicable requirements of the Directive 93 42 EEC Annex II Name Adresse und Kennnummer mdc medical device...

Page 28: ...Baldus Medizintechnik GmbH Auf dem Schafstall 5 56182 Urbar Germany 49 0 261 96 38 926 0 49 0 261 96 38 926 21 office baldus medizintechnik de www baldus medical com...

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