Vibrasat Pro Instructions for Use Rev B March 2019

IMPORTANT READ CAREFULLY BEFORE USE KEEP FOR FUTURE CONSULATION

© Möller Medical GmbH All rights reserved. No part of this documentation may be reproduced or translated in any way whatsoever without prior written approval from Möller Medical GmbH. The status of the information, specifications and figures in these instructions for use is indicated by the version number on the last page. Möller Medical GmbH reserves the right to make changes in terms of technology, functions, specifications, design and information at any time and without prior notification. Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany

Vibrasat® Pro Contents

Contents 1

General safety information ... 5

1.1

Explanation of the safety symbols used ... 5 1.1.1

Symbols used in the instructions for use: ... 5

1.1.2

Symbols appearing on the device: ... 5

1.1.3

Symbols appearing on the packaging: ... 6

1.2

Explanation of the format conventions used ... 7

1.3

Manufacturer's responsibility ... 8

1.4

Operator's obligation to exercise diligence ... 8

1.5

Warning notices ... 9

1.6

Non-product-related additional equipment... 9

1.7

Single use ... 9

1.8

Precautionary measures ... 10

1.9

Target group (user) ... 10

2

Intended use ... 11

2.1

Proper use – intended use Vibrasat® Pro ... 11

2.2

Contraindications ... 11

2.3

Complications ... 11

2.4

Essential performance features... 11

2.5

Combination with other products ... 11

3

Product description ... 12

3.1

Vibrasat® Pro Wand (handle) ... 12

3.2

Vibrasat® Pro Console ... 13

3.3

Foot switch... 13

3.4

Cannulas... 13

4

Setup and commissioning... 14

4.1

Unpacking the device and checking the scope of supply ... 14

4.2

Suitable operating environments Vibrasat® Pro ... 14 Page 3 of 34

Vibrasat® Pro Contents 4.3

Setup and commissioning ... 15

4.4

Disassembly ... 17

5

Application and operation ... 18

5.1

Vibrasat® Pro Console description of the operating elements ... 18 5.1.1

5.2

Display ... 19

Operation ... 19 5.2.1

Setting the vibration speed Vibrasat® Pro Wand ... 19

5.2.1.1

Boost function ... 19

5.2.2

Vibration control ... 20

5.2.3

Warning notices ... 20

6

Cleaning and care ... 21

6.1

Vibrasat® Pro Wand... 21

6.2

Vibrasat® Pro Console ... 21

7

Help in the event of a fault... 22

8

Service ... 23

8.1

Software update ... 23

9

Periodic safety checks ... 26

10

Disposal ... 27

11

Appendix ... 28

11.1 Key technical data... 28 11.2 General data ... 29 11.3 Electromagnetic emissions ... 30 11.4 Electromagnetic immunity ... 31 11.5 Recommended safety distances ... 33 11.6 Accessories ... 33

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Vibrasat® Pro General safety information

1 General safety information 1.1 Explanation of the safety symbols used In these instructions for use, important information is indicated visually. These references are prerequisites for preventing hazards to patients, operating personnel and third parties, as well as for avoiding damages or malfunctioning of the device.

1.1.1 Symbols used in the instructions for use: Caution! Hazard for patients, operating personnel and third parties. Information or help

1.1.2 Symbols appearing on the device: Applied part Type B Serial number (the first 4 digits indicate the year and month of manufacture in YYMM format) Conformity in accordance with the Medical Device Directive 93/42 EEC Observe instruction manual Manufacturer Complies with ANSI/AAMI ES 60601-1 CAN/CSA 22.2 No. 60601-1-08 Alternating current Return and disposal as per the WEEE Directive

O

Device switched off

I

Device switched on Device selector switch on / standby Foot switch

Page 5 of 34

Vibrasat® Pro General safety information

Start/stop button

Up button to increase the stroke rate

Down button to lower the stroke rate Device connected to superordinate control unit Control device warning message

1.1.3 Symbols appearing on the packaging: Consult instructions for use

Catalogue number Batch code Serial number (the first 4 digits indicate the year and month of manufacture in YYMM format) Use by YYYY-MM-DD Sterilised using ethylene oxide

Not suitable for use with MRI Single use Do not resterilise Do not use if package is damaged

Stacking limit, do not store more than 4 packs high

Keep dry

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Vibrasat® Pro General safety information

Restriction on relative storage humidity Storage temperature limitation Manufacturer Conformity in accordance with the Medical Device Directive 93/42 EEC Consult instructions for use Applied part Type B Keep in a place protected against sunlight Caution! Observe transport and storage conditions. Attention: Under US federal law, this device may be only sold to a physician or ordered by a physician.

1.2 Explanation of the format conventions used In these instructions for use, different fonts are used to improve orientation. Font

Use

Bold and italics

Buttons in instructions.

Small capitals

Dialogue fields and submenus in running text.

Italics

Device options, buttons and references to chapter and sections in the running text.

The use of the Vibrasat® Pro is subject to thorough knowledge and observance of these instructions for use, which are delivered as part of the product. Store the instructions for use for the Vibrasat® Pro carefully. The device must be used only by persons who have the required training or knowledge and experience.

Page 7 of 34

Vibrasat® Pro General safety information 1.3 Manufacturer's responsibility The manufacturer may only be regarded as responsible for the safety, reliability and suitability for use of the devices if: •

Assembly, expansions, resetting, changes or repairs are performed by individuals authorised by the manufacturer.

•

The electrical installation in the room in question complies with the relevant requirements and regulations (e.g. VDE 0100, VDE 0107 or IEC specifications).

•

The devices are used in accordance with the instructions for use and the country-specific regulations and national deviations are observed.

•

The conditions stated in the technical data are observed.

Any other use exept those described in the operating instruction is not intended and will result in an exclusion of warranty and liability The manufacturer undertakes to accept old devices as per the German Electrical and Electronic Device Act (ElektroG).

1.4 Operator's obligation to exercise diligence The operator is responsible for the proper operation of the medical device. In line with the German Medical Device Operator Ordinance (MPBetreibV), the user must perform a wide range of duties and also assume responsibility when handling medical devices within the framework of his activities. Only qualified personnel may operate the Vibrasat® Pro . Whenever the Vibrasat® Pro is handled and used, precise knowledge and compliance with these instructions for use is necessary. The devices may only be operated by persons with the necessary training or knowledge and experience. The devices are subject to special precautionary measures with respect to electromagnetic compatibility (EMC) and must be installed and operated in accordance with the EMC guidelines. If one of the devices no longer works properly due to a malfunction, the device must not be used any further and must be inspected by the technical service. Performance and safety may be impaired if Original Equipment Manufacturer device parts are not used. All work that requires tools must be performed by the manufacturer's technical service or parties authorised by the latter.

Page 8 of 34

Vibrasat® Pro General safety information 1.5 Warning notices • • • • • • • • • • • • •

The devices must not be modified. No liquids must be allowed to penetrate the current-carrying parts of the device. When cleaning, ensure that no cleaning agent runs into the connector sockets. Disconnect the power cable before cleaning. The housing of the Vibrasat® Pro Console is only connected as functional earth with the earth contact of the power supply. Replace connecting cables of all kinds even if they are only slightly damaged; make sure not to roll over cables. Keep the cables away from heat sources. This prevents the insulation from melting which could cause a fire or an electric shock. Do not use force to push plugs into sockets. When removing plugs, do not pull on the cables. To remove, release the plug lock if necessary. Do not subject the devices to strong heat or fire. Do not subject the devices to hard impacts. If heat, fumes or smoke appear, disconnect the devices from the mains immediately. When reprocessing the devices, observe the reprocessing instructions in order to avoid damaging the products.

1.6 Non-product-related additional equipment Additional equipment which does not belong to the device’s scope of supply and which are connected to the device’s analogue and digital interfaces must be shown to satisfy the relevant EN specifications (e.g. EN 60601 for electromedical devices). Anyone who connects additional devices becomes the system configurator and is thus responsible for ensuring that the valid version of the system requirements as per the standard IEC 60601-1 is observed. If components are used that do not correspond to the original parts, the performance, safety and EMC behaviour may be impaired.

1.7 Single use Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. Cleaning, disinfection and sterilisation may compromise essential material properties and product parameters leading to device failure.

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Vibrasat® Pro General safety information

Dispose of the used single-use product according to your hygiene requirements.

1.8 Precautionary measures The application results vary depending on the patient’s age, site of intervention and the surgeon’s experience. The application results may or may not be permanent. Sterilise all reusable components of the Vibrasat® Pro as per the reprocessing instructions and replace all the disposable components before using the Vibrasat® Pro on another patient.

1.9 Target group (user) The Vibrasat® Pro is reserved for use by doctors who can demonstrate that they have the necessary expertise through the relevant specialist training or approved, specialist further training.

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Vibrasat® Pro Intended use

2 Intended use 2.1 Proper use – intended use Vibrasat® Pro The Vibrasat® Pro, consisting of the control unit and a handle with a connecting cable has the intended use to vibrate cannulas n particular to support the hand movement of the user.

2.2 Contraindications • • • • • • • •

Clotting disorders or intake of anticoagulant medication Massive hernias Serious heart diseases Serious lung diseases Serious liver damage Serious kidney damage Risk of thrombosis (thrombophilia) Diabetes

2.3 Complications • • • • •

Vascular injuries Nerve injuries Tissue injuries Organ injuries Death

2.4 Essential performance features The Vibrasat® Pro does not have any essential performance features.

2.5 Combination with other products Only accessories that have been specified and approved by the device manufacturer should be used. Please contact the device manufacturer if you are unsure.

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Vibrasat® Pro Product description

3 Product description

Figure 1 1

Vibrasat® Pro Wand handle

9

Foot switch cable

2

Vibrasat® Pro Wand connecting cable

10

On / Off switch

3

Vibrasat® Pro Console control device

11

Connection socket for Vibrasat® Pro Wand

4

Mains cable

12

Connection sockets for foot switch

5

Mains plug

13

Mains input socket

6

Foot switch cable

14

USB socket, service interface

7

Foot switch

15

USB socket

8

Foot switch

16

Vibrasat® QuickLock cannula holder

3.1 Vibrasat® Pro Wand (handle) The Vibrasat® Pro Wand handle (Figure 1, Point 1) transfers very rapid vibrations in an axial direction to a cannula connected to the handle and thus supports the user’s hand movements.

Page 12 of 34

Vibrasat® Pro Product description 3.2 Vibrasat® Pro Console The Vibrasat® Pro Console (Figure 1, Point 3) is the control unit for the Vibrasat® Pro. There is an On / Off switch on the rear of the device for the device standby mode and for the device interfaces for the foot switch (2 foot switches can be operated simultaneously) Vibrasat® Pro Wand and mains plug. All the application parameters are controlled using the capacitive buttons on the front of the Vibrasat® Pro Console . The Vibrasat® Pro Console software can be updated using the USB interface on the rear (Figure 1, Point 14). It must be noted that this is a service interface. The procedure is described in Chapter 8.

3.3 Foot switch

On / Off

Down button

On/Off button

Up button

The foot switches (optionally available as accessories) can be set in the same way as the buttons on the Vibrasat® Pro Console. Both foot switches behave identically. Both connection sockets on the rear are equal.

3.4 Cannulas Only the designated Möller Medical GmbH cannulas may be attached to the Vibrasat® Pro Wand handle. An up-to-date list of the available cannulas can be found in our Brochure or on our website www.moellermedical.com.

Page 13 of 34

Vibrasat® Pro Setup and commissioning

4 Setup and commissioning Make sure that the box is not damaged on delivery to you. The forwarder must be notified immediately of any transport damage. Check all products for damage. Damaged products must not be used. Please contact your supplier immediately.

4.1 Unpacking the device and checking the scope of supply Delivery of the Vibrasat® Pro comprises at least 2 packaging units, depending on the scope of the delivery. Make sure that no parts remain in the packaging when unpacking the Vibrasat® Pro . Packaging unit Vibrasat® Pro Console: •

1 Vibrasat® Pro Console

•

1 mains cable

•

1 USB service interface release key

•

1 instructions for use

Packaging unit Vibrasat® Pro Wand •

1 Vibrasat® Pro Wand

•

1 cannula holder

•

10 O-rings (not sterile)

•

1 reprocessing instructions

It is advisable not to dispose of the packaging and to use it again for any service required. Only send the devices in their original packaging to prevent damage during transportation.

4.2 Suitable operating environments Vibrasat® Pro The Vibrasat® Pro is suitable for environments in the following areas: •

Professional healthcare facilities with specific requirements Clinics (rooms in A+E, hospital rooms, intensive care, operating theatres, except for in the proximity of active facilities of RF surgery devices or outside of the RFshielded room for magnetic resonance imaging, first aid facilities).

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Vibrasat® Pro Setup and commissioning

•

Home healthcare Practices, lodgings (places of residence, nursing homes), hotels, guest houses and stationary vehicles, provided that the devices are not connected to the vehicle's DC power supply.

The Vibrasat® Pro is not approved for use in aircrafts or military applications. The appropriate EMC requirements for these environments have not been tested.

4.3 Setup and commissioning Before commissioning, the Vibrasat® Pro Console must be processed as per the hygiene guidelines (see Chapter 6). The Vibrasat® Pro Wand and the cannula holder must be processed as per the reprocessing instructions provided by the manufacturer. If the devices Vibrasat® Pro Console and Vibrasat® Pro Wand had been exposed to temperature or humidity fluctuations during transport or other change of place, they need to rest for at least 2 hours in the operating environment before restart.

•

Place the Vibrasat® Pro Console on a suitable, stable surface or, if available, use the Vibrasat® Pro fastening kit. Fasten the fastening kit to a standard rail. Put the Vibrasat® Pro Console on the plate and secure it to the fastening kit using the screw supplied.

•

Connect the foot switch (optional) to the Vibrasat® Pro Console using the connecting cable.

•

Insert the mains cable in the designated connector on the Vibrasat® Pro Console and in a socket with a connected earth wire. Observe the voltage indicated on the identification plate.

•

Press the On / Off switch on the rear of the Vibrasat® Pro Console to switch it to standby mode.

•

Remove the sterile Vibrasat® Pro Wand from its packaging under sterile working conditions and connect it to the Vibrasat® Pro Console.

•

Connect the cannula holder to the handle Vibrasat® Pro Wand.

Page 15 of 34

Vibrasat® Pro Setup and commissioning

Figure 2

1. Push the cannula holder (Figure 2, Point 1) onto the fork-shaped pin on the handle (Figure 2, Point 4). The tube connection can be aligned upwards or downwards as required. The alignment of the tube connection can be rotated by 180° if necessary. The O-rings (Figure 2, Point 2 and 5) must be in perfect condition. 2. Attach the cannula holder by tightening the lock nut (Figure 2, Point 3) against the Oring by hand. The cannula holder must be locked into place! The O-ring prevents the nut from becoming loose during use. Do not use tools. The use of tools damages the device.

Figure 3

•

Attach a suitable suction tube (available as an accessory) on the cannula holder. 1. Push the tube through the tube holder on the rear end of the handle (Figure 3, Point 1). 2. Attach the suction tube to the tube connection of the cannula holder (Figure 3, Point 2).

Page 16 of 34

Vibrasat® Pro Setup and commissioning

Figure 4

Figure 5

•

Connect a suitable cannula for the application to the cannula holder. For this, hold the lock (Figure 4, Point 1) pressed down whilst attaching until the square of the cannula hold locks into place. Then push the cannula at the attachment further, beyond the marked line (Figure 5), until it audibly clicks into place.

The Vibrasat® Pro is now ready for use.

4.4 Disassembly •

Press the unlocking button on the cannula attachment and pull the cannula out of the cannula holder.

•

Firstly pull the suction tube out of the cannula holder and then out of the tube holder.

•

Turn the lock nut of the cannula holder anticlockwise vis-à-vis the handle Vibrasat® Pro Wand and push the released nut up to the handle housing.

•

Pull the cannula holder off the handle.

•

Pull the connecting cable of the Vibrasat® Pro Wand off the Vibrasat® Pro Console.

After each use, the Vibrasat® Pro Console must be processed as per the hygiene guidelines (see Chapter 6) and the Vibrasat® Pro Wand must be processed as per the reprocessing instructions provided by the manufacturer.

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Vibrasat® Pro Application and operation

5 Application and operation Always note: • • • •

• •

The handle may only be loaded in an axial direction. The device switches off for safety reasons if subjected to excessive radial force. Large radial forces will damage the handle. If the cannula holder (connection for suction tube and suction cannula) is subjected to excessive forces, the handle will be damaged. All handling of the device requires precise knowledge and compliance with these instructions for use. The device may only be used by specialist staff.

5.1 Vibrasat® Pro Console description of the operating elements After switching on the device using the On / Off switch on the rear, a brief display test is performed. After starting, the display shows the last set value when the device was switched off (stroke rate per minute = vibration speed). The stroke rate can be set between 3000 strokes per minute and 5000 strokes per minute. The stroke rate can be set in standby mode and in vibration mode in increments of 100. The Vibrasat® Pro features a boost function. A description of this can be found in Chapter 5.2.1.1.

Page 18 of 34

Vibrasat® Pro Application and operation 5.1.1 Display 3

2

6

1

5

4

1. Segment display shows the set stroke rate per minute 2. Start / Stop – vibration button ON/OFF 3. Signal display – connected to the superordinate control unit 4. Minus - button to lower the stroke rate 5. Plus - button to increase the stroke rate 6. Warning – in the event of malfunctions (e.g. handle is not connected)

5.2 Operation To make work as simple and convenient as possible, the Vibrasat® Pro provides various operating options.

5.2.1 Setting the vibration speed Vibrasat® Pro Wand Setting the desired vibration speed in strokes per minute. The setting can be made at any time with one of the following actions: • •

Press the Plus / Minus buttons on the Vibrasat® Pro Console Press the Up / Down buttons on the foot switch

Pressing once increases or reduces the vibration speed by 100 strokes/minute. Pressing for longer increases/lowers the speed automatically.

5.2.1.1 Boost function The boost function can only be activated on the Vibrasat® Pro Wand . Press the button on the Vibrasat® Pro Wand for longer than 2 seconds to start the boost with 6000 strokes per minute for max. 1 minute. The button must remain pressed during this time. The device then switches automatically to the last set vibration speed. Page 19 of 34

Vibrasat® Pro Application and operation 6000 is shown briefly on the Vibrasat® Pro Console. 60 s is then decremented on the display. If during the boost, the foot switch or play button on the Vibrasat® Pro Console is pressed, the vibration is switched off and the 60 s timer is reset. The timer is also reset if the button on the Vibrasat® Pro Wand is released within 60 seconds. Repeat activation of the boost function can cause the temperature of the handle to rise.

5.2.2 Vibration control Switching the cannula vibration on and off: • • •

Press the Start / Stop button on the Vibrasat® Pro Console Press the button on the Vibrasat® Pro Wand Press the On / Off button on the foot switch

If the Vibrasat® Pro Wand is switched on, the ring on the Start / Stop display lights up.

5.2.3 Warning notices If prohibited operating states occur during vibration, the Vibrasat® Pro Wand is switched off and a corresponding warning ID is shown on the display. In addition, the warning symbol is displayed. The error must be acknowledged with the Start / Stop button and the vibration switched on before the Vibrasat® Pro Console switches on the Vibrasat® Pro Wand again. Alternatively switch the Vibrasat® Pro Console off and on again. •

If the prohibited operating states occur repeatedly, contact the Möller Medical GmbH service centre.

Warning displays Warning ID

Error description

100

Motor speed does correspond to set value

106 - 108

Device initialisation failed

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Solution not Reduce the load and check that the Vibrasat® Pro Wand is running smoothly. Contact the service centre.