4.9.2 Application area........................... 24 4.9.3 Combination with non-medical products .................. 25 4.9.4 Multiple socket outlets......................... 25 4.9.5 Permissible system load...................... 25 4.9.6 Reprocessing.......................... 25 4.9.7 Maintenance .......................... 25 5 Preparation.............................. 27 Unpacking the product ........................... 27 Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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7.3.3 Functional test .......................... 59 Repairing the product .......................... 59 Disposing of the product ........................ 59 8 Accessories and spare parts ........................ 61 Accessories............................. 61 9 Electromagnetic compatibility........................ 63 General notes on the operating environment .................. 63 Accessories and lines .......................... 63 Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ......................... 67 10 Faults and messages .......................... 69 10.1 Troubleshooting ............................ 69 10.2 Software messages .......................... 69 11 Overview of risks and warnings ........................ 75 11.1 Warnings .............................. 75 12 Subsidiaries.............................. 76 Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. NOTICE ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
The device must not be used for the following treatments: – Applications that require a non-pulsatile flow – Administration of medication – Thorax drainage – Magnetic resonance tomography Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Joints in the foot, knee, hip, shoulder, hand or finger SPINE Thoracic and lumbar vertebral column ENT/NEURO Cleaning endoscope lenses 2.7 Intended conditions of use The product may only be used in hospitals and doctors’ offices in suitable ambient conditions. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Mobility Can be moved if placed on a cart. Combination Can be used on the patient at the same time as other devices. Control Can be controlled via the KARL STORZ SCB. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Dispose of disposable products properly after use. 3.6 Combination with other components Combination of the product with unsuitable instruments and devices can result in uncontrolled behavior and injury to patients, users, and third parties. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
All electrical installations of the operating room in which the product is connected and used must meet the applicable IEC standards. Use either the power cord supplied by KARL STORZ or a power cord which has the same properties and which bears a national mark of conformity.
When using explosive narcotic gases: Operate the product outside of the hazard zone. Do not use the product in the presence of flammable anesthetics. The product must not be operated in oxygenated environments. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
The integration of the product in an IT network can interfere with the function of the product or other devices in the IT network. Do not connect the product with an IT network or other devices. Only the KARL STORZ Service may use the interfaces for USB and Ethernet.
Required accessories for the respective software package are listed in chapter Accessories and spare parts [p. 61]. 4.2 Product overview ENDOMAT SELECT – Front view Pump rollers TFT touch screen Light barrier Power switch Pump lever (cartridge locking lever) Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
SCB connectors Power cord socket Connection socket, e.g., for footswitch The KARL STORZ SCB interface, which is based on the CAN fieldbus, permits remote control of device functions and remote display of device parameters. Tubing set for single use 4.3 Touch screen The user interface of the touchscreen is subdivided into the following areas: Instructions for use •...
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10% steps from 10% – 50%. Irrigation/suction display The irrigation or suction function is activated: – Actual value: white bar – Set value: orange marking and number Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
4.3.1 Symbols on the user interface Symbol Meaning Start/stop standby / pump activated Start/stop Suction using footswitch Alarm audio on Alarm audio paused (30 s) Call up menu Cancel Reject changes Confirm Accept changes Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Local regulations take precedence over IEC and ISO standards. If you have any questions, please contact your local KARL STORZ representative or technical customer support.
4.6 Technical data Designation Value Operating voltage (AC) 100–240 V Operating frequency 50/60 Hz Power consumption 72 VA Electrical protection class Degree of protection acc. to IP 21 IEC 60259 Applied part type according to IEC 60601-1 Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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VET SURG – Bottle suction: 300 – 1,000 ml/min; incre- ments: 100 ml/min Operating volume 500 ml/min – 41 dBA | 1,500 ml/min – 65 dBA | 2,500 ml/min – 69 dBA | 3,500 ml/min – 71 dBA Dimensions (L x H x W) 260 x 110 x 305 mm Weight 4.7 kg Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Federal (USA) law restricts this device to sale by or on the order of a physician. Medical device Prevention of pollution by electronic devices Separate collection of electrical and electronic devices. Do not dispose of in household refuse. Manufacturer Date of manufacture Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
4.9.2 Application area Aside from the applied parts, no other parts of the system are suitable for use within the patient environment. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
After the initial assembly of all system components, perform a safety test according to IEC 62353. If the assembly is carried out at the factory, the protocol of the safety test is supplied. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Product description Have the safety check carried out and recorded yearly by an electrician; see chapter Safety inspection in accordance with IEC 62353 [p. 59]. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
This product and the connected accessories may only be used in medical rooms with electrical installations conforming to the applicable national regulations. 5.3 Connecting the product Connect the potential equipotential cable. Connect the power cord. Push the mains plug fully into the power socket. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
CALCUSON or UNIDRIVE S III. Connect the SCB cable. Connect the other end of the SCB cable to a KARL STORZ control device or other SCB devices; see the instructions for use of the KARL STORZ SCB control NEO system. To remove the SCB cable, be sure to pull on the plug. The SCB cable is equipped with a guard to prevent it from being pulled out accidentally.
ð After confirmation, a ready signal sounds, see chapter Availability signal [p. 57]. WARNING! Risk of injury! Only use the device if the ready signal was audible. ð The selection of disciplines appears: Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Start the product; see chapter Putting the product into operation [p. 29]. ð The screen for selecting the discipline appears: Human medicine Veterinary medicine Select the discipline. ð The screen for selecting the procedure appears: Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Inspect the product for visible contamination before use. Reprocess the product before initial use and before and after all subsequent applications. Use validated methods. Do not use contaminated products. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Install the tubing set. Make sure that the pump tubing is not crushed. ð If the tubing set and procedure match, the last selected procedure appears, e.g.: ð If the tubing set and the procedure do not match, an error message appears: Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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[p. 30]. Turn the pump lever of the tubing set counter clockwise. Connect the tubing ends with the irrigation bag (puncture needle) or with the irrigation connector on the instrument (LUER-Lock). Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
ENDOMAT SELECT and CALCUSON Observe the instructions for use of the CALCUSON. Observe chapter System description [p. 24]. Observe the package insert of the tubing set (art. no. 97000138). Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Mark the surface of the suspension on the right side of the product (as seen from the front) with a pencil. Maintain a distance of 2 cm from the side rail. Apply the adhesion promoter thinly and evenly to the marked area. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Allow the adhesive to dry sufficiently, as the adhesive develops its full bond strength only after several hours. 10. Hang the bottle holder in the suspension. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
ENDOMAT SELECT. Actuate the second position of the footswitch to activate the CALCUSON. ð The green pilot lamp (1) lights up when ultrasonic energy is emitted. The function is being performed correctly. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
ENDOMAT SELECT. Connect ENDOMAT SELECT and UNIDRIVE S III to the optional control cable (art. no. 20701070). ð The ENDOMAT SELECT can only be controlled with the footswitch of the UNIDRIVE S III. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Activate the shaver on the handpiece. ð The ENDOMAT SELECT increases the intracavity pressure via the "boost" function. The pressure increase compensates for the loss of fluid caused by the suction connected to the shaver. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Place the suction bottle in the bottle stand on the product; see chapter Install the bottle holder [p. 35]. Install the tubing set; see chapter Installing the tubing set [p. 31]. Attach the inflow tube (3) of the tubing set to the suction bottle connection with wire tray. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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If there is a height gradient between the patient and the suction bottle, the suction bottle may run full. Therefore, the suction bottle must be placed at the height of the patient. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Connect the inflow tube (1) to the connector on the instrument. Connect the outflow tube (2) to the collection container. Vent the tubing system; see chapter Venting the tubing system [p. 47]. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
In the Menu screen, tap the Settings sub-menu. ð The Settings screen appears with the following sub-menus: 6.2.1 Setting the language In the Settings screen, tap the Language sub-menu. ð The Language screen appears. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
ü The Advanced or VET software package is installed. In the Settings screen, tap the Other setting sub-menu. ð The Other setting screen appears. Enter the desired setting and confirm with ð The Settings screen appears. Reset settings with Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Service area. A maximum of 200 entries are displayed, and the most recent entry is in the top line on page 1. Each line contains the following event data: Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
6.4 Product information Information on the product can be queried, e.g., serial number, software version, and operating hours. In the Menu screen, tap the Device info sub-menu. ð The Device info screen appears. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Have a collecting container ready to catch irrigant solution as it runs out. Tap the Start/Stop button and let the roller pump run until all of the air has been released from the tubing system. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
ð If the actual value of the irrigation pressure (white bar) exceeds the set value (orange marking), the roller pump stops the irrigation. 6.6.3 Suction Press the footswitch. Close the patient tubing with your finger and check whether a vacuum forms. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
ð The actual value (2) of the irrigation flow is displayed as a white bar. Tap the start/stop button again to deactivate the roller pump. The standard value of the pressure limit without an installed Advanced software package is 500 mmHg. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
For all pressure-controlled procedures, the irrigation pressure can be set between 20 and 150 mmHg, except for VET ART "large animal", for which an irrigation pressure of up to 400 mmHg is possible. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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ð The actual value (2) of the irrigation pressure is displayed as a white bar. Tap the start/stop button or the footswitch button again to activate the roller pump. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
An activated roller pump can start at any time, and the rollers of the pump can cause crushing. Never reach into the pump. Do not wear loose clothing. Bind long hair together. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
6.8.2 Starting and ending the suction Tap the footswitch button or the start/stop button (RES) to start the suction process. ð The white bar shows the actual value of the suction flow. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Application Tap the footswitch button or the start/stop button again to stop the suction process. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
The alarm is displayed with blue text on a cyan background in the title line. The alarm will overwrite any other text messages. 7.2.1.2 Acoustic alarm signal The alarm signal is a burst of 2 tones lasting for 170 ms each, with a pause of 240 ms: Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
The minimum duration of the display is 5 s. The signals are ordered according to priority. Alarm signals have a higher priority than information signals. Information signals are divided into five different priorities. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Putting the product into operation [p. 29]. The pitch of the availability signal is modulated with a frequency of 1.5 Hz by ± 2 Hz each time. There are 5 different harmonics. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Pump up the leakage tester and generate the following pressure: Uro – CYST / Gyn –HYS = 60 mmHg, SPINE – LUMBAR / ART – Knee / VET ART – small animal = 300 mmHg. ð The visual and acoustic excess pressure warning is output. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Document the results of the safety test. 7.4 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries).
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Maintenance, servicing, repairs, and disposal Contact KARL STORZ SE & Co. KG, a KARL STORZ branch or an authorized dealer to find out the address of the collection point in your area. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Tubing set, suction, DS, reusable, can be UP009 sterilized Tubing set, suction, FS, reusable, can be UP007 sterilized Tubing set, suction, PC, reusable, can be UP008 sterilized Leakage tester 13242XL Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Order no. One-pedal footswitch 20014230 Recommended accessories for boost actuation Article Order no. One-pedal footswitch 20014230 Recommended accessories for Advanced package Article Order no. SCB connecting cable, length 100 cm 20090170 Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
The power supply qual- transients/bursts ity should be that of a ± 1 kV for input and ± 1 kV for input and acc. to IEC typical commercial or output lines output lines 61000-4-4 hospital environment. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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80 MHz 80 MHz bances, induced 1 kHz 80% AM modu- 1 kHz 80% AM modu- by radio-fre- lation lation quency fields acc. 6 V in ISM band 6 V in ISM band to IEC 61000-4-6 Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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– guidelines Conducted HF distur- 3 V 3 V Portable and mobile HF bances acc. to IEC communications equip- 150 kHz to 80 MHz 61000-4-6 ment should be used no closer to any part of the Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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If abnormal perfor- mance is observed, additional measures may be necessary, such as re-orienting or relocating the product. Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/ Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range ap- plies. Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Electromagnetic compatibility The product was tested for compatibility with HF surgical devices in accordance with IEC 60601-2-2 Appendix BB. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
Remove the tubing set h ago, deviation in pressure briefly and then start the values pump again. 150: Pump stopped Communication or pressure Function of the product is in- measurement disrupted terrupted. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Function of the product is in- terrupted. Re-activate the pump if the error message is automatically reset. 254: Default restored File error Information message. Work is possible. Check the time setting if necessary. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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FE: A touch screen activation The text message is part of lasting more than 30 seconds the calibration procedure of has been detected. the touch screen (see text message 500) and is dis- Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Electronics error in the Switch the product on speedometer and off. Contact KARL STORZ Service if the error reoccurs. 0x766: Index moved Electronics error in the Switch the product on speedometer and off. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Error in the monitoring system Switch the product on and off. Contact KARL STORZ Service if the error reoccurs. 0x775: PS error (H on) Error in the monitoring system Switch the product on and off. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
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Contact KARL STORZ Service if the error reoccurs. 0x790: WD task error BE: Program crash Switch the product on and off. Contact KARL STORZ Service if the error reoccurs. Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...
WARNING No modification of this medical electrical (ME) equipment is allowed. WARNING Instructions for use • ENDOMAT SELECT UP210 • MQS390_EN_V1.0_03-2021_IFU_CE-MDR...