Asskea proVisio M28 Instructions For Use Manual
Secretion aspirator
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Summary of Contents for Asskea proVisio M28
- Page 1 Instruction for Use ® ASSKEA secretion aspirator proVisio 0843 GA29 / revision D / 04.2016...
- Page 2 Annex I of this directive. ® The ASSKEA secretion aspirator proVisio M28 has been tested in accordance with IEC 62353. The quality management system applied by ASSKEA GmbH is certified in compliance with the relevant international standards. ® The ASSKEA secretion aspirator proVisio M28 is a medical aspirator classified as class lla in accordance with EU Council Directive 93/42/EEC, Annex IX.
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Page 3: Table Of Contents
Startup ............................16 3.2.1 Connecting the reusable secretion canister ..............17 Operation ............................ 19 ® 3.3.1 Control elements and indicators of the ASSKEA secretion aspirator proVisio M28 ..............................19 3.3.2 Setting the vacuum ......................20 3.3.3 Aspiration ..........................20 Decommissioning ........................ - Page 4 Technical data ............................32 EMC information ..........................33 ® Electromagnetic environment in which the ASSKEA secretion aspirator proVisio may be operated ........................34 Handling of electromagnetic interactions ................36 List of all cables and transformers replaceable by the user ..........36 Order information accessories ......................
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Page 5: User Information
Please read the safety instructions (see section 1.6) to avoid hazards. ® This instruction for use forms an integral part of the ASSKEA secretion aspirator proVisio M28. Therefore please keep this instruction for use in an easily accessible place. ®... -
Page 6: Operating Elements
The Protection Class specifies the degree of protection of the device against contact and ingress of liquids. ® The ASSKEA secretion aspirator proVisio M28 is protected against finger access and falling water drops at an inclination of up to 15°. -
Page 7: Purpose
(potentially) come into contact with the aspirate must be cleaned, disinfected and replaced if necessary. Reconditioning may only be performed by ASSKEA GmbH or by a service partner authorized by ASSKEA GmbH. resp. -
Page 8: Contraindications
Basic safety instructions - ATTENTION! Warning of damage due to improper power supply Improper operation causes overvoltage in the device, which may be transmitted to the operator. Ensure prior to startup that the mains supply for connecting the ASSKEA secretion aspirator ® proVisio M28 is suitable at 100V to 240V AC and a mains frequency of 50-60Hz. - Page 9 The use of accessories and spare parts, detachable parts or materials that are not recommended by ASSKEA GmbH and specified in the instruction for use may compromise the safety and function of the device. Any warranty is excluded for damage caused by using accessories and spare parts not recommended or by improper use.
- Page 10 (strong heating of the device) resp. inhalers or steam kettles (excessive air humidity). Do not operate ® such devices and sources in the vicinity of the ASSKEA secretion aspirator proVisio M28. Page 10 of 38...
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Page 11: User Requirements
Training on how to handle the ASSKEA secretion aspirator proVisio M28 is provided by ASSKEA GmbH or an authorized distribution partner of ASSKEA GmbH. Product training takes approximately one to two hours and, among other things, includes an explanation of the design and function of the device, the handling of the device, the cleaning and disinfection as well as the procedure to be followed for each new patient and for disposal. -
Page 12: Product Description
® the ASSKEA secretion aspirator proVisio ® the instruction for use of the ASSKEA secretion aspirator proVisio the power supply unit GlobTek GTM91099-6015-3.0-T2 reusable secretion canister system (incl. suction tube and fingertip) rinsing bottle, reusable (250 ml) ... -
Page 13: Information On The Bacterial Filter
® The ASSKEA secretion aspirator proVisio M28 is operated via the internal battery or via the supplied power supply unit that can also be used to recharge the battery. A rotary vane pump generates the desired vacuum. After 5 minutes of operation, the device switches off automatically to prevent overheating. The device should be left switched off for at least 5 minutes to ensure sufficient cooling of the device. -
Page 14: Information On The Battery
The battery is covered by warranty for 6 months. Wearing parts are excluded from the warranty. ASSKEA GmbH is responsible for impacts on safety, reliability and specific performance only if: original ASSKEA accessories and replacement parts are used, ... -
Page 15: Operation
Switch off the device when emptying the reusable secretion canister. If secretion has been aspirated into the device, it must be properly processed by ASSKEA GmbH or by a service partner authorized by ASSKEA GmbH! Damage of the device due to insufficient acclimatization ... -
Page 16: Startup
Information on the permissible environmental conditions during operation can be found in section 7 `Technical data´. ® Fig. 2 Connection of the ASSKEA secretion aspirator proVisio M28 to patient and accessories Startup Take the device and the accessories out of the packaging. -
Page 17: Connecting The Reusable Secretion Canister
3.2.1 Connecting the reusable secretion canister 1. Fold the moving part of the secretion canister lid slightly upwards and place the secretion canister lid on the secretion canister. Fig. 3 Fig. 4 2. Fold the moving part of the secretion canister lid downwards so that the hooks snap into place and the secretion canister is securely closed. - Page 18 4. Insert the secretion canister into the canister fitting provided on the device by guiding it over the rack on the bottom and pivoting it into the device until it snaps into place. Fig. 8 Fig. 9 5. Connect the suction tube to the port in the middle of the secretion canister lid. In doing so, ensure that the tube is fixed sufficiently tight.
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Page 19: Operation
Operation 3.3.1 Control elements and indicators of the ASSKEA secretion aspirator ® proVisio Vacuum setting `High´ Vacuum setting `Medium´ Vacuum setting `Low´ LED status indicator for battery operation LED status indicator for mains operation On/off button Fig. 11 Symbol Description... -
Page 20: Setting The Vacuum
Symbol Description Meaning of display display illuminates Power supply unit is connected, voltage available. continuously green Incorrect power supply unit is connected, no charging of display blinks red battery possible! button illuminates Device is switched on and ready for use. continuously green Device still runs for 30 sec. -
Page 21: Decommissioning
The reuse of bacterial filters for multiple patients is prohibited for hygiene and safety reasons! For each new patient, processing by ASSKEA GmbH or by an authorized service partner of ASSKEA GmbH is strictly required! After each aspiration, all components that have come into contact with the aspirate must be cleaned, disinfected or disposed of. - Page 22 7. Empty and clean the reusable secretion canister and the lid according to section 4.1.3 resp. 4.2.3. 8. Remove the used bacterial filter before a new patient uses the device or when it has already been used for one patient for 2 weeks. Move the lever that is in the horizontal position a quarter turn counterclockwise so that the lever points vertically downwards subsequently.
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Page 23: Maintenance
The reuse of bacterial filters for multiple patients is prohibited for hygiene and safety reasons! For each new patient, processing by ASSKEA GmbH or by an authorized service partner of ASSKEA GmbH is strictly required! After each aspiration, all components that have come into contact with the aspirate must be cleaned, disinfected or disposed of. -
Page 24: Cleaning And Disinfection Of The Surface Of The Device
5. Afterwards, rinse the components thoroughly and let them dry. 6. Reinsert the sphere according to fig. 19. ASSKEA GmbH recommends to replace the canister system every 4 weeks if it is used and disinfected frequently! Page 24 of 38... -
Page 25: Cleaning/Disposal Of The Suction Tube
3. Afterwards, rinse the suction tube thoroughly with clear water and let it dry. Even when the suction tube is used for one patient only, ASSKEA GmbH recommends to replace the suction tube at least every 4 weeks since the material may become discolored and brittle due to frequent applications! 4.1.5... -
Page 26: Cleaning And Care In The Homecare Area
However these do not affect the function of the device. If the interior of the device comes into direct contact with liquids or solids, the device must be inspected by ASSKEA GmbH or by a service partner authorized by ASSKEA GmbH. Page 26 of 38... -
Page 27: Hygienic Cleaning And Disinfection Of The Reusable Secretion Canister
15 minutes once a day. 5. Afterwards, rinse the components thoroughly and let them dry. 6. Reinsert the sphere according to fig. 20. ASSKEA GmbH recommends to replace the canister system every 4 weeks if it is used and cleaned/disinfected hygienically frequently! 4.2.4 Hygienic cleaning and disinfection of the suction tube 1. -
Page 28: Further Use Of The Device
All accessories must be cleaned and disinfected before the device is returned. The device itself may be treated with a surface disinfectant. In order to avoid time lags, notify ASSKEA GmbH prior to returning the device and mark the shipping carton of the device with the label `Used Medical Device´. -
Page 29: Inspection Of The Asskea Secretion Aspirator Provisio ® M28
® ASSKEA GmbH neither ensures proper operation for the ASSKEA secretion aspirator proVisio M28 nor is ASSKEA GmbH liable for any resulting property damage or personal injuries if: - original ASSKEA accessories and spare parts are not used, - the user instructions in this instruction for use are not followed, - installation, settings, modifications, enhancements or repairs are not performed by ASSKEA GmbH or by personnel authorized by ASSKEA GmbH. -
Page 30: Troubleshooting
5. Troubleshooting Malfunction Display Probable cause Remedy Connect the power supply Battery is discharged. unit for charging. do not illuminate Connect the correct power Battery is discharged and Device does supply unit, check the blinks red impermissible input voltage. not start power supply. -
Page 31: Transport, Storage And Disposal
`Used Medical Device´ label to the shipping carton! Please notify ASSKEA GmbH of the return in advance. The product return form can be found on the web page of ASSKEA GmbH at www.asskea.de in the service area under product return. -
Page 32: Technical Data
7. Technical data ® Model name ASSKEA proVisio Flow rate* (measuring point at suction 30 l/min ± 2 l/min (high flow) tube nozzle) max. -90 kPa (~ -900 mbar; -675 mmHg) (high vacuum) Vacuum Conversion factor: 1 kPa ~ 7.5 mmHg; 1 kPa ~ 10 mbar... -
Page 33: Emc Information
If the use of the ASSKEA secretion aspirator ® proVisio M28 adjacent to or stacked with other devices is required, the ASSKEA ® secretion aspirator proVisio M28 and the other devices should be monitored in... -
Page 34: Electromagnetic Environment In Which The Asskea Secretion Aspirator Provisio ® M28 May Be Operated
M28 is intended for operation in the electromagnetic environment specified below, in which the RF disturbances are controlled. The customer or the ® user of the ASSKEA secretion aspirator proVisio M28 must ensure that it is operated in such an environment. - Page 35 Power supply DC Phenomenon Test method Immunity test levels Fast transient electrical ±2 kV IEC 61000-4-4 disturbances/bursts 100 kHz repetition frequency ±1 kV line-to-line Impulse voltages/surges IEC 61000-4-5 ±2 kV line-to-ground 0.15 MHz to 80 MHz 6V in ISM bands and amateur Conducted RF disturbances IEC 61000-4-6 radio bands between...
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Page 36: Handling Of Electromagnetic Interactions
® location for the ASSKEA secretion aspirator proVisio M28, if the permissible electromagnetic environment cannot be ensured or if you have observed functioning of the ASSKEA secretion ® aspirator proVisio M28 or of another device in the vicinity that is not intended. -
Page 37: Order Information Accessories
9. Order information accessories Item number Description ® Reusable secretion canister proVisio (1000 ml) 100741 ® Lid for reusable secretion canister proVisio 100742 ® Reusable secretion canister system proVisio 100743 (incl. suction tube and fingertip) Sphere for overflow protection 100278 ®... -
Page 38: Publishing Information
10. Publishing information Created and published by: ASSKEA GmbH Haßlocher Straße 9 99189 Gebesee GERMANY Contact details: Phone: +49-36201-5797-0 Fax: +49-36201-5797-33 E-Mail: info@asskea.de www.asskea.de Page 38 of 38...
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