Atmos S 351 NATAL Operating Instructions Manual
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Summary of Contents for Atmos S 351 NATAL
- Page 1 Operating Instructions ATMOS S 351 NATAL English 0124 GA1GB.210302.0 E349855 2020-06 Index 01...
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Page 2: Table Of Contents
4.11 Changing the secretion canister ................28 4.12 Warning messages ....................28 4.13 Trolley for ATMOS S 351 with standard rail (REF 320.0070.0) ......29 4.14 Trolley for ATMOS S 351 (REF 444.0020.0)............29 4.15 Foot controller ......................30 4.16... - Page 3 Reprocessing ....................31 Safety instructions for reprocessing ..............31 5.1.1 General safety instructions ................31 5.1.2 Danger for users, patients and third parties ..........31 5.1.3 Avoiding damage to the device ................ 31 Preparing and completing reprocessing .............. 32 Preparing surfaces ....................32 5.3.1 Overview ......................
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Page 4: Introduction
ATMOS S 351 NATAL, 115 V 444.0491.2 ATMOS S 351 NATAL, 127 V 444.0491.3 ATMOS S 351 NATAL – basic set, 230 V 444.0490.0 ATMOS S 351 NATAL – basic set, 100 V 444.0490.1 ATMOS S 351 NATAL – basic set, 115 V 444.0490.2... -
Page 5: Explanation Of Pictures And Symbols
ATMOS S 351 NATAL – basic set, 230 V (Medi-Vac®) 444.0492.0 ATMOS S 351 NATAL – basic set, 230 V (Serres®) 444.0493.0 ATMOS S 351 NATAL mobile, 230 V 444.0481.0 ATMOS S 351 NATAL mobile, 100 V 444.0481.1 ATMOS S 351 NATAL mobile, 115 V 444.0481.2... - Page 6 Warning; pay special attention This product complies with the relevant requirements of EU Directives. 0124 This product complies with the relevant requirements of EU Directives. UL Listing Mark MEDICAL — GENERAL MEDICAL EQUIPMENT E349855 AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) CAN/CSA-C22.2 No.
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Page 7: Intended Use
Store in a dry place Protect from sunlight 1.3 Intended use Product name: ATMOS S 351 NATAL Main function: An electric suction pump controlled by a microprocessor generates negative pressure. Due to the controlled negative pressure, parts of the body, in particular the head of a baby, are fixed. - Page 8 Intended use / intend- Vacuum extraction, surgical suction (among others: suction ed purpose: curettage, suction biopsy), bronchial suction in newborns Intended user / user Medical staff (among others: gynaecologists, midwives) profile: Intended patient Generally, female patients of child-bearing age with and group: without restrictions; newborns. Disease state to be Inapplicable diagnosed, treated or...
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Page 9: Function
Warning notes: The following complications can occur during vacuum extrac- tion or suction: • Cerebral haemorrhages • Cephalohaematomas • Skin abrasions on the child’s head • Haematomas • Perineal, vaginal, cervical tears • Bleeding • Injuries to vessels and nerves •... -
Page 10: Scope Of Delivery
1–9 ATMOS S 351 NATAL – basic set, 127 V 444.0490.3 1–9 ATMOS S 351 NATAL – basic set, 230 V (Medi-Vac®) 444.0492.0 1, 2, 3, 4, 5, 6, 12, 13 ATMOS S 351 NATAL – basic set, 230 V (Serres®) 444.0493.0... -
Page 11: Transport And Storage
Only transport the product in a shipping carton that is padded and offers sufficient protection. If damage occurs during transport: 1. Document and report damages in transit. 2. Send the device to ATMOS; see chapter „6.3 Sending in the device“ on page 41. Ambient conditions for transport and storage: • Temperature: −10...+60 °C • Relative humidity: 30...95% without condensation... -
Page 12: Notes For Your Safety
2 Notes for your safety The safety of the ATMOS S 351 NATAL complies with the accepted standards of technolo- gy and the guidelines of the German Medical Devices Act. 2.1 General safety instructions Familiarise yourself with the device in good time so that you are capable of operating it at any time. - Page 13 • Perform a function check after each use. • ATMOS recommends always having another suction device ready at hand. That way you can also perform suctioning if a device should fail. • Please observe the notes on the electromagnetic compatibility (EMC) of the device.
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Page 14: Avoiding Damage To The Device
Never operate the product in potentially explosive areas or in areas that are oxygen- ated. • Only use original accessories and original spare parts from ATMOS. This applies to the power cable in particular. Tripping hazard due to cables. Injuries and fractures are possible. - Page 15 The device may become damaged. • Ensure that no liquid enters the device. Once liquid has entered the device, it may no longer be used. In this case, clean the device and send it to ATMOS for repair. • Always place the device on firm, level ground. The device must always be in a vertical position when you use it.
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Page 16: Setting Up And Starting Up
3 Setting up and starting up 3.1 Device overview Front view ON / OFF switch Display Support for canister system Bacterial filter Connection for suction hose Secretion canister lid Connection for extraction cup Rear view Pump connection Connection for foot controller Service interface for data read-out Potential equalisation Mains supply... -
Page 17: Secretion Canister
3.1.1 Secretion canister Reusable canister system Locking handle Knurled screw for locking the lid insert and for adjusting the clamping force Release button Fill-level sensor with anti-foaming device Lid rim Aperture for double hose connector Contacts for fill-level monitoring Disposable canister system Serres® canister system Angle (connection for disposable suction hose) Serres®... -
Page 18: Preparing The Device
3. If the device is damaged: document and report the damages in transit. Send the device to ATMOS (chapter „6.3 Sending in the device“ on page 41). 4. If the device is not damaged: place the device on a safe, level surface. -
Page 19: Connecting The Secretion Canister System And Hoses
3.4 Connecting the secretion canister system and hoses 1. The anti-foaming device must be placed on the fill-level sensor for strongly foaming secretion. 2. Slide the secretion canister lid with the release button pointing forward onto the secretion canister. Make sure that the lid rim is under the bead of the secretion canister. -
Page 20: Operation
• Relative humidity: 30 ... 95% without condensation • Atmospheric pressure: 700 ... 1060 hPa 4.2 Control panel S 351 NATAL high vacuum / high ow Button for switching on the automatic vacuum build-up (ON) Button for switching off the automatic vacuum build-up (OFF) LEDs for indicating the active function... -
Page 21: Switching Off The Device
4.4 Switching off the device 1. Turn off the device by pressing the ON / OFF switch. The display takes about 3–4 seconds to turn off. 4.5 Explanation of the display The display shows the current settings of your ATMOS device. Foot controller Connected with trolley SEMI Semi-automatic vacuum extraction mode... -
Page 22: User Menu
4.7 User menu Display Operation Options 1. Press the ON / OFF switch and • Language immediately afterwards the ON • Vacuum unit button (1). • Vacuum » The user menu appears. extraction 2. Press the – button (5) to scroll •... -
Page 23: Vacuum Extraction
Display Operation Options 4.7.3 Vacuum extraction Four parameters can be set in the • Final vacuum vacuum extraction menu. • Increase time 1. Press the + (6) or – (5) button to • Decrease go to the desired parameter. time 2. -
Page 24: Brightness
Display Operation Options 4.7.3.4 Mode 1. Press the + (6) or − (5) button to • SEMI set the desired mode. • AUTO 2. Confirm the value by pressing the MAX button (7). » The mode is set. You are automat- ically redirected to the vacuum extraction menu. To return directly to the vacuum extraction menu, press the OFF button (2). -
Page 25: Vacuum Steps
• For vacuum extraction, we recommend that you use a small secretion canister (1.5 l) so that the required vacuum can be generated with the least possible delay. • During automatic vacuum build-up, the ATMOS S 351 NATAL generates vacuum evenly and final vacuum is reached in the preset time. -
Page 26: Additional Functions
• The pump output is increased, if possible, to counteract the leak. • The warning signal stops as soon as vacuum build-up can be continued or after the user cancels the action. The ATMOS S 351 NATAL cannot predict that the extraction cup will tear off. There is no warning for this. 4.8.3 Vacuum drop after final vacuum has been reached •... -
Page 27: Final Vacuum Is Not Reached
The ATMOS S 351 NATAL cannot predict that the extraction cup will tear off. There is no warning for this. 4.8.4 Final vacuum is not reached • If the time for vacuum build-up has elapsed and the final vacuum has not been achieved, the device will wait for about another 35 s and then issue a warning sig- nal: fast flashing of a red LED and a beeping sound synchronised with the blinking LED. • The warning signal indicates a leak in the system which prevents the final vacuum from being achieved. • The warning signal stops as soon as the final vacuum is reached again or after the user cancels the action. -
Page 28: Changing The Secretion Canister
4.11 Changing the secretion canister Change or empty the secretion canister when it is 2/3 full. WARNING Risk of infection. Death or serious injuries from infection. Always wear disposable gloves when changing the secretion canister. 1. Stop the suction process by switching off the pump. 2. Remove the double hose connector from the full secretion canister. 3. -
Page 29: Trolley For Atmos S 351 With Standard Rail (Ref 320.0070.0)
Please provide sufficient too high. cooling. Service is required. Contact ATMOS Service. 4.13 Trolley for ATMOS S 351 with standard rail (REF 320.0070.0) 1. Mount the device on the trolley tray using a screw. 4.14 Trolley for ATMOS S 351 (REF 444.0020.0) 1. -
Page 30: Foot Controller
1. Plug the foot controller into the connection. 2. Connect the suction catheter, suction attachment or suction instruments to the suction hose. 3. Switch on the ATMOS S 351 NATAL. Make sure that the pilot lamp in the ON / OFF switch lights up. 4. Select the desired final vacuum using one of the buttons (5), (6) and (7). Keeping the –... -
Page 31: Reprocessing
5 Reprocessing 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 required results of cleaning and disinfection are achieved. -
Page 32: Preparing And Completing Reprocessing
Unsuitable cleaning agents and disinfectants. The product can become damaged. • Do not use any process chemicals containing the following ingredients on plastic parts: • Chloramides or phenol derivatives • Do not use abrasives. Incorrect mechanical cleaning and disinfection. Corrosion due to moisture. •... -
Page 33: Selecting Process Chemicals
5.3.2 Selecting process chemicals Follow the manufacturer’s instructions for the process chemical. Cleaning agent (manufacturer) Active ingredients in 100 g Type Disinfection Green & Clean SK <1 g dialkyldimethylammonium chloride, <1 g alkyldimethyle- Liquid (Metasys) thylbenzylammonium chloride, <1 g alkyldimethylbenzylammo- nium chloride Dismozon®... -
Page 34: Wipe Cleaning
5.3.3 Wipe cleaning 1. Disconnect the device from the mains power supply. 2. Clean the surface evenly with a suitable cloth and suitable cleaning agent; see chap- ter „5.3.1 Overview“ on page 32. Pay particular attention to hard-to-reach areas. » No more residue is visible. -
Page 35: Secretion Canister System
Cleaning agent (manufacturer) Active ingredients in 100 g Type Disinfectants – Manual reprocessing Gigasept® FF neu (Schülke <5% phosphonates, <5% anionic surfactants, <5% Liquid & Mayr) non-ionic surfactants, perfumes, methylisothiazoli- concentrate nones Cleaning agent (manufacturer) Active ingredients in 100 g Type Cleaning agents –... -
Page 36: Hoses
Mechanical cleaning 1. Empty the secretion canister. and disinfection 2. Clean and disinfect using a suitable programme: Pre-rinse: 1 min • Pre-rinse with cold water Clean: 5 min • Cleaning with cleaning agent 50 °C / 122 °F • Neutralisation with neutralising agent Neutralise: 2 min •... - Page 37 Pre-cleaning Pre-cleaning is only necessary for mechanical cleaning and disinfection. Flushing: 5x / 30 s 1. Clean the accessories evenly under running water. 2. Rinse the hollow spaces and lumina of the accessories thoroughly under running water. Disassembly Not necessary. Mechanical cleaning 1.
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Page 38: Maintenance And Service
ATMOS recommends: work should be carried out by an authorised ATMOS service partner. This ensures that repairs and tests are carried out professionally, original spare parts are used and warranty claims remain unaffected. -
Page 39: Function Test
6.2.2 Function test • The device switches on. The power switch lights up green • The extraction mode is set correctly (SEMI / AUTO) • Recognition of the foot controller and trolley (REF 444.0020.0 only), if available, is shown on the display •... -
Page 40: Monitoring
• Suction mode: - Switch on the device. The device is in the preset extraction mode - Press the ‘OFF’ button - The device switches to normal suction mode - The extraction mode symbol disappears from the display - The vacuum can be preset using the ‘+’, ‘−’ and ‘MAX’ buttons - Press the ‘MAX’... -
Page 41: Sending In The Device
5. The product must be well padded and packed in suitable packaging. 6. Place form QD 434 ‘Delivery complaint / return shipment’ and the corresponding Decontamination certificate in an envelope. 7. Affix the envelope to the outside of the package. 8. Send the product to ATMOS or your dealer. Maintenance and service... -
Page 42: Troubleshooting
Check whether the secretion canister the secretion canister and its secretion canister lid have and the device. locked into the holder correctly and whether the ATMOS S 351 NATAL has been screwed correctly to the trolley. Warning message Bacterial filter is blocked. Replace the bacterial filter. during suction (filter... - Page 43 (ATMOS S 351 blocked. NATAL has over- Ambient temperature is Use the ATMOS S 351 NATAL only in heated). too high. the specified temperature range. Try using auto standby (less heat build- up). Fan is defective.
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Page 44: Accessories
Extraction cup – Malmström Ø 50 mm 404.0156.0 Extraction cup – Malmström Ø 60 mm 404.0157.0 ATMOS Cup – extraction cup made of silicone Ø 50 mm 404.0194.0 ATMOS Cup – extraction cup made of silicone Ø 60 mm 404.0193.0 Suction curette, with secondary air pipe, Ø... -
Page 45: Consumables
9 Consumables Consumables Hydrophobic bacterial and viral filter, Ø 11 mm 443.0738.0 Hydrophobic bacterial and viral filter, Ø 8 mm 444.0628.0 Bacterial filter for ATMOS DDS secretion canister, 10 pcs. 340.0054.0 Silicone hose for safety canister – secretion canister 443.0046.0 Silicone hose for connecting nipple – bacterial filter 320.0044.0 Silicone hose for safety canister – secretion canister (trolley) 444.0118.0 Silicone hose for bacterial filter – safety canister 999.0128.0 Suction hose, PVC, Ø 8 mm, L = 2.10 m, 50 pcs. -
Page 46: Disposal
The product does not contain any hazardous materials. 1. Clean and disinfect the product. 2. In Germany: send the product back to ATMOS or your specialist dealer. They will dispose of the product properly. 3. In other countries: Dispose of the product properly and in accordance with country-specific laws and regulations. -
Page 47: Technical Data
11 Technical data Voltage 230 V~ ± 10%; 50/60 Hz Special voltage: • 100 V~ ± 10%; 50/60 Hz • 115 V~ ± 10%; 50/60 Hz • 127 V~ ± 10%; 50/60 Hz Current consumption • max. 0.5 A (230 V~) •... - Page 48 Protective earth conductor max. 0.1 resistance max. 0.5 mA Earth leakage current max. 0.1 mA Housing leakage current max. 0.1 mA Patient leakage current Heat output approx. 135 J/s Noise level < 54 dB (A) @ 1 m (according to ISO 7779) Ambient conditions for transport/storage •...
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Page 49: Notes On Emc
12 Notes on EMC Medical electrical devices are 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 product is suitable for use in the following environments: •... -
Page 50: Notice
13 Notice 50 Notice... -
Page 51: Notice
14 Notice Notice... - Page 52 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch/Germany Phone: +49 7653 689-0 atmos@atmosmed.de www.atmosmed.com...