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conTenTs

1. important information and intended use

2. indications, contraindications and side effects

3. nitrous oxide system components and technical specifications

3.1 front view and icons

3.2 Main menu

3.3 sedation menu

3.4 Bag T

3.5 Back and side views

3.6 Technical specifications

4. scope of delivery and accessories

5. assembly instructions

6. safety and regular controls

6.1 General safety instructions

6.2 safety features

6.3 information signals and error codes

6.4 regular checks

6.5 ambient air contamination

7. handling and hygiene

8. effective troubleshooting

9. frequently asked questions

10. declaration of conformity

Содержание Bag T

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

Страница 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 medizintechnik de www baldus medical com ...

Страница 3: ...ag 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 6 2 Safety features 19 6 3 Information signals and error codes 20 6 4 Regular checks 21 6 5 Ambient air contamination 23 7 Handling and hygiene 25 8 Effective troubleshooting 26 9 Frequently asked qu...

Страница 4: ...ted 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 systems ...

Страница 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 the mixer Never use the unit without first taking an advanced training course on how to handle and use these units Ensure to careful ly observe the content of the advanced training course from which ...

Страница 6: ...care 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 It must be moni tored using a vacuum control block refer to Section 4 Accessories Vacuum control block can be ordered as an accessory refer to Section 4 Baldus scavenger system accesso ries and instru...

Страница 7: ...e 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 from isolated use Slight decrease in heart rate Slight decrease in heart beat volume Respiratory effects Minimal or no respiratory depression If the effect is insufficient consider other forms of anaes...

Страница 8: ...ete 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 oxygen concentrations Con nector complies with the DISS standard Diameter Index Safety System 3 1 Front view and icons 1 O2 flush button 100 pure oxygen immediately flows into the breathing bag once th...

Страница 9: ...e 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 immediately with a 5 l min total flow and 0 N2 O 100 O2 2 Start sedation with anonymous patient The seda tion display is shown without having entered a patient ID Sedation starts immediately with 5 l mi...

Страница 10: ...e 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 individually as learned during the advanced training course 3 3 Sedation menu 1 Concentration controller 4 Concentration monitor 2 Flow regulator 5 Recovery 3 Mute button 6 Menu 1 Concentration controller Th...

Страница 11: ...reathe 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 pressing the button An oxygen mask is not manda tory with nitrous oxide sedation but it is useful in the practice in case of emergency Use only the Baldus De mand Mask in combination with the Baldus Touch ...

Страница 12: ...format 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 pressure reducer N2 O pressure reducer O2 pressure hose N2 O compressed gas cylinder O2 compressed gas cylinder Oxygen nitrous oxide mixer Breathing bag Scavenger system Gas supply hose spiral hose Vacu...

Страница 13: ...ration 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 concentration 50 Product variant 4 Baldus Bag T Compatible with Baldus Touch 50 60 70 Matrx MDM D Cabinet Mount Digital Flowmeter Porter Digital MDM Porter MXR 1 Cabinet Mounted Flowmeter Porter MXR D Digital Fl...

Страница 14: ...ucer 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 15018 Pulse Oximeter with Alarm Limits e g OxyTrueA 15030 Suction Unit e g mobile nitrous evacuator suction pump dental chair suction unit etc Item no Product 51516160 Leak Detection Spray for finding...

Страница 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 Bal dus Medizintechnik GmbH which is ISO 13485 certified can also install a centralised gas supply 50 litre cylinders are usually used The cylinders must stand securely and be protected from tipping ...

Страница 16: ...re 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 in the Baldus All in One Cart or plasterboard at least 12 5 mm see photos The units must not be in stalled in carts which are not approved by Baldus Fig 13 Pressure reducers connected to gas cylinder...

Страница 17: ...there 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 and 22 mm downwards and draw the third point for the screws there 2 4 Now go from the point for the nozzle out 15 mm to the left and 22 mm downwards and draw the fourth point for the screws there 3 The...

Страница 18: ...ons 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 types open just the oxy gen cylinder and set a total flow e g 5 l min ensur ing that the N2 O concentration is 0 the N2 O cylinder must be kept closed Only oxygen should now flow if everything has bee...

Страница 19: ...utage 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 sedated patient and let him exhale the nitrous oxide through the ambient air Depending on the nitrous oxide concentration administered the patient should only leave the practice after approx 30 60 m...

Страница 20: ...low 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 window appears and must be acknowledged In addition an acoustic information signal is audible This event is recorded in the error memory log The sedation continues but without N2 O and therefore with...

Страница 21: ...can 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 access the Maintenance menu and various information All errors which have arisen can be read and exported for example Furthermore all data relating to sedations can be read and exported number of sedati...

Страница 22: ...y 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 water and bubbles form quickly at the site of any leak This test is performed for each cylinder change and monthly at least also after returning the unit for checking and before initial opera tion All le...

Страница 23: ...ars 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 and loosen the pres sure reducers and pressure hoses by hand if you wish 6 5 Ambient air contamination Nitrous oxide occupational exposure limit value as per TRGS 900 German nitrous oxide occupation...

Страница 24: ...in 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 Opening them quickly can cause the pressure reducers to malfunction Leak at the bag Annual maintenance and inspection Weekly quick check for leaks refer to Regular checks Too much nitrous oxide in the...

Страница 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 press the Recovery button and switch off the unit after a suf ficient recovery phase with pure oxygen The length of the recovery phase depends on the length of sedation and maximum nitrous oxide conce...

Страница 26: ...eople 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 cold Yes but only if you can clear their nasal passages us ing a nasal spray k Do I have to change the mask for every patient Yes Each patient needs a new autoclaved nasal mask 8 Effective troublesho...

Страница 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 GmbH der Benannten Stelle Kriegerstraße 6 70191 Stuttgart Name address and identification 0483 number of Notified body Konformitätsbewertungsverfahren Conformity assessment procedure Anhang II Annex...

Страница 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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