remOVE DC IMPULSE Instructions for Use Rev 06

remOVE DC Impulse Instructions for use Revision 06 Date 2017-06-19 For remOVE DC Impulse Version 1.XX Ref No.: 400.01 Ovesco Endoscopy AG Dorfackerstr. 26 72074 Tuebingen Germany +49 7071 98979 160 [email protected] www.ovesco.com

Contents 1

About this document ...4

2

Components ...5

3

Accessories / replacement parts ...5

4

Description ...6

5

Intended use / indication ...7

6

Contraindications ...8

7

Complications / warnings / precautions ...8

8

Components and products required for use ...10

9

Preparation...10

10

Use of product ...13

11

Mode of operation ...15

12

Error message...16

13

Cleaning and disinfection ...17

14

Transport and shipping / storage ...18

15

Maintenance / repair ...20

16

Disposal ...21

17

Operating conditions ...21

18

Specifications ...22

19

Electromagnetic compatibility (EMC) ...24

20

Warranty...28

21

Symbols ...29

Appendix 1 ...30

1

About this document These instructions for use refer to the following product: Product

Manufacturer

remOVE DC Impulse Ref. No. 400.01 Version 1.XX

Ovesco Endoscopy AG Dorfackerstr. 26 72074 Tuebingen Germany

The instructions for use are part of the product. When using the instructions for use, please observe the following: 1. Read the instructions for use carefully before first use of the product. Before first use, users should fully understand how the product works, how to handle the product and which possible risks are connected to use of the product. 2. Store the instructions for use in a place accessible to medical staff. 3. Pass on the instructions for use to every subsequent owner or user of the product. 4. Update the instructions for use according to all amendments and revisions issued by the manufacturer. These instructions for use include proprietary information subject to copyright law. It is not permitted to duplicate this document or portions of this document by photocopying or other means of replication without prior written consent by the manufacturer of the product. The manufacturer assesses the right to alter the contents of these instructions for use without prior notice. Due to continuous further development of the product, it is possible that technical specifications and figures in this document are not up-todate. Maintenance and repair may only be performed by the manufacturer or by any person or persons authorized by the manufacturer. Unauthorized opening or performance of services by any non-authorized person or persons voids the warranty and the manufacturer’s liability with regards to operational safety.

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The manufacturer’s warranty does not cover primary or secondary damage and defects resulting from improper or unreasonable use or maintenance, especially resulting from failure to follow the instructions for use.

2

Components

A B C D

remOVE DC Impulse Foot-activated switch with connector cable DC cord Power cord Test instrument for electrical tests

Figure 1: Components of the remOVE DC Impulse (Ref. No. 400.01)

3

Accessories / replacement parts Please only use original parts or parts certified by the manufacturer as compatible with the remOVE DC Impulse as accessories or replacement parts. Otherwise safety and functionality cannot be guaranteed. The following accessories / replacement parts for the remOVE DC Impulse may be ordered separately: Accessory / replacement part Max. length Ref. no. Foot-activated switch with connector cable 2m 400.03 DC cord 2m 400.04 Power cord* 2.5 m 400.10.XX Test instrument for electrical tests** 2.2 m 810101 * When ordering the power cord, please note the country of use. ** The test instrument must be only used during electrical testing. – Non-sterile. – Not suitable for patient cases.

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The remOVE DC Cutter Set 12 / 14 (Ref. no. 400.02.01 / 400.02.02) is not included with the remOVE DC Impulse and has to be ordered separately: Product remOVE DC Cutter Set 12 / 14 (remOVE DC Cutter, remOVE SecureCap 12 / 14, remOVE Grasper, remOVE Shield)

4

Ref. no. 400.02.01 / 400.02.02

Description

1 2 3 4 5

ON/OFF switch ON/OFF display Status display: charge of battery / ready for use / error Connection foot-activated switch Connection DC cord Figure 2: Front view of the remOVE DC Impulse

6 7 8

Name plate Connection to power supply Fuse Figure 3: Back side view of the remOVE DC Impulse

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Figure 4: Name plate of remOVE DC Impulse

5

Intended use / indication The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC ® and FTRD® clips made by Ovesco Endoscopy AG for the digestive tract. Clips produced by Ovesco Endoscopy AG are: Product

Ref. No.

OTSC® System Set

100.03, 100.04, 100.05, 100.06, 100.07, 100.08, 100.09, 100.10, 100.11, 100.12, 100.13, 100.14, 100.27, 100.28, 100.29, 100.30, 100.31

OTSC® Reloader

200.37, 200.38, 200.39, 200.40, 200.41, 200.42, 200.43

FTRD® System Set

200.70

OTSC® Proctology

200.60

It is not permitted to use the remOVE DC Impulse outside of its intended use as specified above. Using the remOVE DC Impulse for fragmentation of objects other than the products specified above may lead to defects and damages to the remOVE DC Impulse, destruction of the remOVE DC Cutter and permanent bonding of remOVE DC Cutter to the object.

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6

Contraindications The remOVE DC Impulse must not be used if flexible endoscopic procedures and/or the fragmentation and removal of an OTSC or FTRD clip manufactured by Ovesco are contraindicated. Fragmentation and removal of a clip are also contraindicated as long as the clinical effect of the clip is still required.

7

Complications / warnings / precautions The complications listed below are possible when using the product for its intended purpose. Damage to the tissue in the digestive tract, particularly: -

Thermal damage to the wall of the respective digestive organ Haemorrhages resulting from damage Perforations; these may also become apparent after medical intervention

According to the official definition in the current standard, the following passage can generally be applied to all medical electrical equipment: “Even the lowest current presents the risk of triggering ventricular fibrillation” (IEC 60601-1, section 8.7.3, A.14). Please check whether the components are complete and/or have any defects before use. Any incomplete or defective components must be replaced. Defective or missing components can lead to malfunctioning of the remOVE System. For example, defective insulation on power lines can cause an electric shock to the patient and/or user. Ignition and/or explosion of flammable gases e.g. due to high oxygen concentration in or outside of the digestive tract are possible during use due to sparking. Before use, ensure that no flammable gases/materials are in reach of the device and/or application point. Electrical conductive cables/parts must not be close or touch the remOVE DC Cutter. Defective lines can cause an electric shock to patient/user. All clip fragments must be removed from the patient's body. If sharp-edged clip fragments are left behind, they could cause damage to the organs in the digestive tract or other abdominal organs. This damage may also become apparent after medical intervention.

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Partially cut and/or truncated clips may no longer fulfil their intended purpose if left in the patient's body. These clips can also break apart, resulting in sharp-edged clip fragments which could cause damage to the organs of the digestive tract or other abdominal organs. This damage may also become apparent after medical intervention. Neuromuscular irritation is highly unlikely during application due to the physical mechanism of action and the technical design of the remOVE System, however it cannot be completely ruled out as a matter of principle. When application takes place in the esophagus there is always a residual risk of neuromuscular irritation, particularly of the heart muscle. Likewise, interference with active cardiac implants cannot be completely ruled out. Please note the following before use in the esophagus: Clinically relevant disturbances of the electrolyte balance, particularly hypokalemia, should be compensated for. A cardiologist should be consulted if necessary. For patients with an implantable cardioverter defibrillator (ICD) a cardiologist must be consulted and it must be considered to disconnect the ICD with monitoring the patient for the duration of the procedure. Applied parts and generator are not protected against defibrillation. Remove instrument before using a defibrillator on the patient. The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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8

Components and products required for use The remOVE DC Impulse may only be used in conjunction with manufacturerapproved accessories and products as detailed in the instructions for use. The use of accessories, cables and transducers, other than those the remOVE DC Impulse was designed for, can significantly increase emissions and reduce immunity of the remOVE DC Impulse against interference.

E F

remOVE DC Impulse incl. accessories remOVE DC Cutter Set 12 / 14 (remOVE DC Cutter, remOVE SecureCap 12 / 14, remOVE Grasper, remOVE Shield)

Ref. No. 400.01 Ref. No. 400.02.01/ 400.02.02

Figure 5: Products required for use

9

Preparation Additional devices to be connected to medical electric devices have to be in compliance with IEC or ISO norms. Additionally, all configurations have to be in compliance with normative requirements for medical systems (see IEC 60601-1-1

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or Section 16 of the third revision of IEC 60601-1, respectively). The person or persons who connect additional devices to medical electric devices are system configurators and are thus responsible for ensuring that the system is in compliance with the normative requirements for systems. Be advised that local law takes precedence over the normative requirements detailed above. When setting up the remOVE DC Impulse please make sure that the user has clear, unobstructed line of sight to the status display. When setting up the remOVE DC Impulse please make sure that environmental factors do not impair the user’s perception of acoustic signals generated by the remOVE DC Impulse. Do not connect the remOVE DC Impulse to the power supply unless a protective earthing conductor is present in order to avoid electrocution. Before use of product please follow the steps detailed below: 1.

Place the device on a stable surface in sufficient distance to the wall, ensuring that the device can immediately be disconnected from power supply if necessary.

2.

Connect the power cord to the remOVE DC Impulse and connect the power cord to the power supply.

3.

Connect the foot-activated switch and the DC cord to the remOVE DC Impulse.

4.

Connect the remOVE DC Cutter to the DC cord. In order to connect the remOVE DC Cutter with the DC cord, align the two markings (red and white dot) on both devices in such a way that the white dot on the plug of the remOVE DC Cutter and the red dot on the plug of the DC cord are opposite to each other, see figure below.

Figure 6: left: remOVE DC Cutter; right: DC cord

5.

Activate the remOVE DC Impulse by pressing the ON/OFF switch. The ON/OFF switch lights up to indicate that the device is activated.

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The status display indicates the charge of the remOVE DC Impulse through green flashing LEDs.

Figure 7: Status display indicates charge during charging phase by flashing green LEDs corresponding to the charge level

If the remOVE DC Impulse has not been in use for more than two days, the internal energy storage is fully charged over a time period of about 10 minutes. If the remOVE DC Impulse has been in use in the past two days, the device might charge faster. Successful completion of charging cycle is indicated through three short acoustic signals in quick succession. The status display indicates operational readiness through emitting constant green light from all eight LEDs.

Figure 8: Status display indicates operational readiness through emitting constant green light from all eight LEDs

6.

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As soon as all eight green LEDs are constantly on, the remOVE DC Impulse is ready for use.

Instructions for use

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10 Use of product The user has to make sure that set-up, assembly and use of the remOVE DC Impulse, all accessories and endoscopic instruments are carried out in accordance with the respective instructions for use. Always use a DC cord to connect the remOVE DC Cutter to the remOVE DC Impulse. Proper operational characteristics of the product are no longer guaranteed if making a direct connection without a DC cord or a connection using several DC cords. This may also lead to damage of the remOVE DC Impulse. Make sure the clip can be removed. If the clip is deeply embedded superficial tissue removal may be necessary to bare the clip. When retrieving the clip fragments, ensure that the clip fragment is completely inside the remOVE SecureCap. The protruding sharp-edged parts of a clip fragment can result in damage to the organs in the digestive tract. Perforations can also arise subsequently after intervention. When inserting and removing the remOVE DC Cutter, check that neither the endoscope nor the remOVE DC Cutter have been damaged, e.g. through kinking the instrument hose. Winding the remOVE DC Cutter too tightly can lead to bending of instrument tip. Bending can make positioning/contacting the clip difficult during use. Check that the remOVE Shield is affixed to the lens before the cutting process and keep a minimum distance of 30-40 mm between the endoscope tip and the clip during the cutting process. The endoscope tip can be damaged by sparking during the cutting process. Affixing the remOVE Shield to the lens and maintaining the maximum possible distance between the endoscope tip and instrument tip reduce the risk of damage. Note that the instrument tip of the remOVE DC Cutter can heat up to 130 °C during the cutting process. Moving the instrument tip immediately after use can lead to superficial burns to the skin. Use of the remOVE DC Cutter in a CO2 atmosphere may reduce the effectiveness of the clip fragmentation.

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Even if the product is used as intended, secondary effects may occur. For this reason, Ovesco products should only be used by persons who are qualified and trained to use the product for its intended purpose. Make sure that the foot-activated switch is not permanently pressed. A single DC pulse is only triggered when the foot-activated switch is pressed during an acoustic contact signal. Permanent activation of the foot-activated switch may cause unintended triggering of a DC pulse. When removing material residue from the instrument tip through a DC pulse, the instrument tip must be shielded from patient, user and any third parties because sparks might occur. If user suffers from red-green color blindness, make sure that the user understands the status display. For use of the product, the following steps have to be observed: 1.

Guide the endoscope to the clip to be removed.

2.

Insert the remOVE DC Cutter through the working channel and establish contact with the clip. A continuous audible signal indicates sufficient electrical contact with the clip.

3.

When a continuous audible signal appears, trigger the cutting process by pressing one time on the foot switch. The audible signal stops and the status display flashes green for about six seconds when the cutting process is complete. Afterwards, the audible signal sounds three times and the status display shows that it is ready for use. To make clip removal easier, the clip should ideally be cut at two spots on opposite sides of the row of teeth.

Figure 9: Spots on the clip for fragmentation: Make first cut at (1), and second cut on the opposite side (2)

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After the cutting process, residues of the clip material can get caught at the instrument tip of the remOVE DC Cutter and create a permanent connection between the electrodes. This is indicated by a constant audible signal without clip contact. The remains can be removed by applying a new DC pulse. It is recommended to withdraw the remOVE DC Cutter from the endoscope first and remove the remains by pressing on the foot switch to trigger a DC pulse. As this can lead to sparking, patients, users or third parties must be shielded from the instrument tip. 4.

Verify that the clip is successfully fragmented at two spots by checking the endoscopic image.

5.

Remove the endoscope and place the remOVE SecureCap on the endoscope tip. Guide the endoscope with the fitted remOVE SecureCap to the clip fragments.

6.

Use the remOVE Grasper to pull the clip fragment into the remOVE SecureCap and retrieve it from the body. Hold the clip fragment firmly with the forceps when withdrawing the endoscope (Fig. 10). Repeat this procedure for the second clip fragment or, if necessary, for further clip fragments.

Figure 10: Clip fragment with remOVE Grasper in the remOVE SecureCap

7.

11

Turn off the remOVE DC Impulse by pressing the ON/OFF switch.

Mode of operation The remOVE DC Impulse is designed to send an electrical direct current pulse of typically IS = 155 A for the duration of 60 ms through the bipolar, endoscopic instrument remOVE DC Cutter. This DC pulse flows through the clip segment the remOVE DC Cutter is establishing contact with, resulting in localized melting of the clip material.

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Figure 11: Left: Establishment of contact between clip segment and remOVE DC Cutter. Right: Cross-section of clip segment to be cut (b) and marking of current path IS between electrodes (a)

The remOVE DC Impulse is equipped with internal energy storage, allowing the device to generate a DC pulse without additional load on the power supply. This internal energy storage is charged before the remOVE DC Impulse generates the DC pulse. The remOVE DC Impulse is designed to ensure that a direct current pulse can only be generated when sufficient contact with a segment of the clip is established. Sufficient contact is indicated through an acoustic signal. Should contact break off between the remOVE DC Cutter and the clip during the application of a DC pulse, the output of the remOVE DC Impulse will be deactivated within less than 500 µs. Breaking-off of contact might occur, for example, if one or both electrodes lose contact with the clip due to successful clip fragmentation. During a DC pulse, the voltage drop between the electrodes of the remOVE DC Cutter is between 1.3 V and 2.0 V. During loss of contact, short-term (max. 500 µs) voltage spikes max. 22 V may occur. These spikes might be transferred into the tissue if both electrodes of the remOVE DC Cutter are in contact with tissue.

12 Error message The remOVE DC Impulse is equipped with a failure detection system. Technical failures are indicated via the status display. Failure detection is implemented to ensure user/patient safety. If a failure message occurs, the device casing may not be opened. Life-threatening electrocution could occur.

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If a failure message occurs, the device may no longer be used in order to ensure the safety of users and/or patients. If a failure occurs, all eight LEDs of the status display are flashing orange, see figure below.

Figure 12: Status display flashes orange during failure message.

If a failure message is displayed by the remOVE DC Impulse, acoustic contact detection between instrument and clip is deactivated. A DC pulse can no longer be generated, and the internal energy storage of the remOVE DC Impulse can no longer be recharged. In the case of failure message or malfunctioning of the device, please contact manufacturer.

13 Cleaning and disinfection As part of your responsibility to ensure hygiene and cleanliness of all product components during use, please make sure that only suitable devices and procedures validated specifically for this product are used for cleaning and disinfection of the product. Please follow the respective local and/or national legislation as well as hygiene regulations pertaining to medical practices or hospitals. 13.1

Wipe disinfection For cleaning surfaces of the device, please use approved cleaning/disinfection supplies and only in accordance with instructions by the respective manufacturer. Observe specifications regarding concentration, temperature and exposure time. Apply alcohol-based cleaning/disinfection agent. Do not use benzyl-alcohol-based and/or any other agents because it can cause damages to the remOVE DC Impulse materials.

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13.2

13.3

Instructions 1.

Prepare the cleaning/disinfectant agent per the manufacturer’s guidelines.

2.

Wipe down the equipment using a cloth with surface disinfectant. Clean gross contamination first and then uniformly treat all the surfaces.

3.

Wipe the surfaces ensuring that they are uniformly treated. Comply with the action time of the disinfectant specified by the manufacturer.

4.

Wet a sponge or cloth in clean water and wipe off the cleaning/disinfection agent.

5.

Dry the device using a clean, lint-free cloth.

6.

Check by visual inspection all surfaces of the equipment. If soil remains visible, repeat the entire cleaning/disinfection procedure.

Safety Instructions Before cleaning the remOVE DC Impulse, disconnect the device from the power supply. Do not use flammable or explosive cleaning or disinfecting solutions. Make sure no fluids enter the device casing. Non-compliance may result in burning hazard and/or electrocution. Only clean and disinfect the product manually. Do not sterilize the product under any circumstances.

14 Transport and shipping / storage 14.1

Transport and shipping Perform surface disinfection and properly package device for shipping. Add another form of packaging, to avoid bacterial contamination and infections once you leave the hospital. Be advised to transport / ship the remOVE DC Impulse in its original, undamaged packaging.

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Make sure the packaging is not damaged and/or wet. Otherwise, the device might get damaged during transport / shipping, which may lead to malfunction during the next use. This, in turn, may endanger the user/patient. When transporting / shipping the device, make sure to follow the respective terms of transport. 14.2

Storage If the remOVE DC Impulse is not stored properly, customer claims may not be considered. Improper storage may also lead to malfunction, which may endanger the user/patient. It is recommended to store the remOVE DC Impulse in its undamaged original packaging. It is recommended to thoroughly clean the remOVE DC Impulse before storing it. Do not expose the remOVE DC Impulse to direct or indirect sunlight or other types of UV radiation. Do not store the remOVE DC Impulse in the vicinity of chemicals, disinfectants and/or sources of radioactive radiation. Do not place heavy objects on top of the remOVE DC Impulse or its packaging. Make sure to store the remOVE DC Impulse in a dry and clean space, ensuring appropriate storage conditions.

14.3

Transport and storage conditions When transporting or storing the remOVE DC Impulse, please make sure that the following environmental requirements are met: Environmental factors Temperature Relative humidity Air pressure

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Storage 0 °C to +50 °C 0 % to 90 %, RH non-condensing 500 to 1060 hPa

Transportation -20 °C to +50 °C 0 % to 90 %, RH non-condensing 500 to 1060 hPa

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15 Maintenance / repair 15.1

In general After every use of the remOVE DC Impulse and its accessories, please check for damages or defects. Pay special attention to intact isolation of all cords and cables. Never use a damaged remOVE DC Impulse or damaged accessories. Immediately replace defective accessories. Make sure that a safety inspection of the remOVE DC Impulse is performed annually.

15.2

Safety inspection Safety inspections have to be performed annually. Consider that national regulations might call for more frequent safety inspections and make sure to have the inspections performed accordingly. When performing a safety inspection, please make sure all national requirements and rules are met. Safety inspections of the device and its accessories may only be performed by qualified personnel with all required knowledge and experience, who are authorized to perform safety inspections without supervision. The inspector documents all testing results and measurements according to the printable inspection record (see appendix of the instructions for use). If considerable deviations or abnormalities are recorded, please contact the manufacturer.

15.3

Repair If repairs are needed, please contact the manufacturer. Do not attempt to repair the device yourself under any circumstances. Ovesco accepts liability with regards to safety, reliability and functionality of the device under the following circumstances: -

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All instructions with regards to installation and intended use given in this document have been followed properly. Modifications, repairs, etc. were only performed by personnel authorized for these tasks by Ovesco.

Instructions for use

remOVE DC Impulse 400.01

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