Subscribe to Our Youtube Channel
Related Manuals for AKRUS ak 5010 MBS
Summary of Contents for AKRUS ak 5010 MBS
- Page 1 Mobile Mammography, Biopsy and Stereotaxy Chair ak 5010 MBS Instructions for Use (IFU) 277g001d_ak5010MBS_Rev09_EN.docx 1 / 35 Rev09 / 2024-07-16...
-
Page 2: Table Of Contents
Accumulator holder ......................15 Electric lift (101-016 / 101-017) and foot-controlled switch (277.012003) ......16 Safety switch ........................16 Control lever for chassis ....................17 Operating the ak 5010 MBS ...................... 18 10.1 Ready for use ........................18 10.2 Motor operating time ......................18 10.2.1... - Page 3 Manufacturer ..........................34 Reporting incidents ........................34 CE marking ..........................34 Wiring diagram .......................... 35 277g001d_ak5010MBS_Rev09_EN.docx 3 / 35 Rev09 / 2024-07-16...
-
Page 4: General Information
General information A thorough understanding of these IFU is essential for use of the ak 5010 MBS examination chair (mobile Mammography, Biopsy and Stereotaxy chair). Please familiarise yourself with the contents, paying special attention to instructions on how to use the device safely. - Page 5 Indicates an imminent hazardous situation. Unless avoided, it will result in death or serious injury. Action required 277g001d_ak5010MBS_Rev09_EN.docx 5 / 35 Rev09 / 2024-07-16...
-
Page 6: Symbols Used
1.4.2 Symbols used 277g001d_ak5010MBS_Rev09_EN.docx 6 / 35 Rev09 / 2024-07-16... - Page 7 (1) Product label for ak 5010 MBS Product label for Adapter footrest MBS Product label for Additive Back support MBS Product label for Additive Back support (viscoelastic) (2) Chair weight (2) Option: Chair weight Max. patient weight (135 kg, 330 lbs) Max.
- Page 8 Down (4) Direction on foot lever. The arrows indicate the direction of movement. Symbol Meaning Manufacturer Date of manufacture (YYYY-MM-DD) Reference number Serial number Label identifying the device as a medical device Device identification (data matrix and plain text) Indicates the maximum permitted weight the product can support. General warning sign Indicates that the product can only be used indoors Applied part type B, in accordance with IEC 60601-1...
- Page 9 Symbol Meaning “Do not load” prohibition sign Any load > 200N is prohibited Consult instructions for use. CE marking – symbol indicates compliance with Machinery Directive 2006/42/EC and the Medical Device Regulation 2017/745/EC Disposal in the EU: do not dispose of with household waste Indicates permissible minimum and maximum relative humidity levels during use Indicates minimum and maximum temperatures to which the product can be safely exposed...
- Page 10 Symbol Meaning Do not open with a sharp blade 277g001d_ak5010MBS_Rev09_EN.docx 10 / 35 Rev09 / 2024-07-16...
-
Page 11: Requirements For Safe Operation
Requirements for safe operation Please familiarise yourself with the contents of these IFU before putting into service the device for the first time. WARNING Please check that the product is working correctly before every use. The medical device may only be installed, operated and maintained by personnel who have received detailed training and have the necessary knowledge and experience. -
Page 12: Product Lifetime And Warranty
Section “Technical Data”. If the medical device shows signs of wear, contact the distributor to have it serviced. Contents at delivery The ak 5010 MBS is delivered with the following items: Item Number ak 5010 MBS... -
Page 13: Intended Purpose
The product is suitable for use in immediate proximity to patients. • The ak 5010 MBS is designed for a maximum patient weight of 135 kg (330 lbs). A 250 kg (550 lbs) • version is also available (with a reinforced lift). -
Page 14: Electrical Connections
Description of the device Accumulator The electric motor in the ak 5010 MBS is powered by a rechargeable accumulator. The accumulator has a capacity of approx. 40 operations per charging cycle when used with a typical load profile. CAUTION Keeping a spare, charged accumulator is recommended. -
Page 15: Accumulator Holder
If any of the above occur, please replace the old accumulator with a new accumulator. Please contact your local AKRUS GmbH & Co. KG authorised distributor. The accumulator is only fully charged when the CHARGE LED goes off after completion of charging. -
Page 16: Electric Lift (101-016 / 101-017) And Foot-Controlled Switch (277.012003)
Electric lift (101-016 / 101-017) and foot-controlled switch (277.012003) The ak 5010 MBS is powered by a low voltage To move the chair up and down, press one of the motor. two foot-operated switches on the right or left of the ak 5010 MBS. -
Page 17: Control Lever For Chassis
Control lever for chassis The ak 5010 MBS features a chassis and two control levers on either side of the lower frame. Foot lever in different positions. There are three possible positions. (1) All wheels move freely and rotate (lever horizontal). -
Page 18: Operating The Ak 5010 Mbs
10 Operating the ak 5010 MBS 10.1 Ready for use The ak 5010 MBS is always ready for use with a charged accumulator. It does not have a main switch, but a safety switch, see chapter 9.6. WARNING Please check that the product is working correctly before every use. -
Page 19: Foot Rest Adapter (277.950300)
CAUTION These adapters are NOT designed as a step-in aid. If needed, attach the adapters after the patient is seated in the ak 5010 MBS. To attach a single block: To attach a double block: tilt the block slightly and lock it into place with the first slide the two blocks over each other and then hook. -
Page 20: Adjusting The Head Rest (277.030600 / 277.030700)
The back rest can be freely adjusted from a vertical to a horizontal position. Pressing one of the two spring- loaded levers behind the head rest (arrow) unlocks the mechanism and the back rest will gently move up or down. 10.7 Adjusting the head rest (277.030600 / 277.030700) CAUTION The adjustment mechanism can be damaged if the end positions are forcibly overtightened. -
Page 21: Optional Accessory: Lateral Back Rest (277.032010)
The back rest brings the patient close enough to the examination device while at the same time allowing the patient to relax. 10.10 Trendelenburg The ak 5010 MBS allows the use of the Trendelenburg position. 277g001d_ak5010MBS_Rev09_EN.docx 21 / 35 Rev09 / 2024-07-16... - Page 22 To do so, secure the ak 5010 MBS by holding the foot rest with one hand. To unlock the mechanism, move the red lever under the seat towards the feet and lower the lying surface. To lock it into this position, pull the red lever back towards the head until it clicks into place.
-
Page 23: Equipment Care And Protection Against Contamination
11.1 Warning notice NOTICE NOTICE Before using the chair for the first time, ak 5010 MBS must be prepared according to these instructions. For at-risk patients, patients with skin damage or to reduce possible contamination in general, we recommend covering the device with a cloth (e.g. a sterile surgical cloth). -
Page 24: Reprocessing Instructions
The accumulator must be removed before the device is reprocessed. The device must be completely dry before the accumulator is reinserted. Preparation Remove the accumulator from the ak 5010 MBS. before cleaning Cleaning For manual cleaning, use ready-to-use “Cleanisept Wipes Maxi” by the manufacturer Dr. -
Page 25: Maintenance And Repairs
Servicing and repairs to this product may only be carried out by personnel authorised by the manufacturer. The ak 5010 MBS does not require maintenance by the user. The following spare parts and accessories can be replaced by the user or maintenance personnel if they show... -
Page 26: Technical Data
Electrical information Accumulator 24 (2.9) Volt (Ah) Duration of short-term motor operation (ID 10) ED 1/9 minutes Upholstery electric conductible (optional) Electrical information for charger Weight depends on configuration of ak 5010 MBS 277g001d_ak5010MBS_Rev09_EN.docx 26 / 35 Rev09 / 2024-07-16... - Page 27 Technical Data Value Unit Power cable (charger) 100-240 Volt Charging time approx. Nominal frequency 50 – 60 Nominal current Fuse T 1.25 //250 AH / V Protection category IP 65 Environmental conditions during use (and during storage in unpacked condition) Environmental temperature +10 - +40 °C...
-
Page 28: Troubleshooting
16 Troubleshooting Fault Possible cause Corrective action Does not work at all Accumulator empty Charge accumulator Safety switch on Unlock safety switch (see also Section 9.6) Accumulator seated Check accumulator seated correctly (see incorrectly Section 9.4) Does not work at all, charge Accumulator faulty Phone the distributor’s service technician accumulator... -
Page 29: Electromagnetic Compatibility
The ak 5010 MBS has not been tested for electromagnetic compatibility with strong magnetic fields. The probability of malfunction due to the presence of strong magnetic fields at the point of use is low. Even so, do not place the ak 5010 MBS near sources of strong, high-frequency magnetic fields. - Page 30 Guidelines and manufacturer's declaration - Electromagnetic emissions The ak 5010 MBS is intended for use in an electromagnetic environment, as specified below. The customer or user of the ak 5010 MBS should ensure that it is used in such an environment.
- Page 31 Guidelines and manufacturer's declaration - Electromagnetic immunity The ak 5010 MBS is intended for use in the electromagnetic environment specified below. The customer or user of the ak 5010 MBS should ensure that it is used in such an environment.
- Page 32 Guidelines and manufacturer's declaration - Electromagnetic immunity The ak 5010 MBS is intended for use in the electromagnetic environment specified below. The customer or user of the ak 5010 MBS should ensure that it is used in such an environment.
- Page 33 5010 MBS chair. The ak 5010 MBS is intended for use in an electromagnetic environment in which RF interference is controlled. The customer or user of the ak 5010 MBS can help prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the ak 5010 MBS depending on the output power of the communications equipment, as specified below.
-
Page 34: Reporting Incidents
(info@akrus.com) or to their local distributor. If an examination chair has failed, and may have resulted in or contributed to serious injury to a surgeon, Akrus or the local distributor and the appropriate local competent authority should be notified immediately. -
Page 35: Wiring Diagram
21 Wiring diagram 277g001d_ak5010MBS_Rev09_EN.docx 35 / 35 Rev09 / 2024-07-16...
Need help?
Do you have a question about the ak 5010 MBS and is the answer not in the manual?
Questions and answers