remOVE DC IMPULSE Instructions for Use Rev 09

remOVE DC Impulse Instructions for use English; Revision 9 Date 26.02.2020 Ref. no. 400.01 Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 72076 Tübingen Germany +49 (0)7071-98979-160 [email protected] www.ovesco.com

Contents 1

How to use these instructions for use ... 4

2

Scope of supply ... 5

3

Accessories and replacement parts ... 5

4

Product description ... 6

5

Intended use / indication ... 8

6

Contraindications ... 8

7

Complications ... 8

8

General information... 9

9

Warnings and precautions ... 9

10

Components and products required for use ... 11

11

Preparation ... 12

12

Use ... 13

13

Notes on the workings of the product ... 16

14

Fault message ... 16

15

Cleaning and disinfection ... 17

16

Transport, shipping and storage conditions ... 18

17

Maintenance and repairs... 19

18

Disposal... 20

19

Operating conditions ... 20

20

Technical data ... 20

21

Electromagnetic compatibility (EMC) ... 22

22

Guarantee ... 25

23

Explanation of the symbols on the packaging... 26

24

Appendix 1: TSC inspection protocol ... 27

1 How to use these instructions for use These instructions for use apply to the following product: Product

Manufacturer

remOVE DC Impulse Ref. no.: 400.01

Ovesco Endoscopy AG Friedrich-Miescher-Str. 9 72076 Tübingen Germany

The manufacturer accepts no liability for direct or consequential damages resulting from improper use, particularly where these instructions for use are not complied with. These instructions for use are part of the product. When referring to these instructions for use, please note the following: 1. Read through these instructions for use carefully before using the product. Users should fully understand how the product works and how it should be handled, along with any potential hazards associated with its use. 2. Store these instructions for use in a location that can be accessed by medical personnel. 3. Pass these instructions for use on to each successive owner or user of the product. 4. Update these instructions for use with any amendments or changes you receive from the manufacturer. These instructions for use contain proprietary information subject to copyright. These instructions for use may not be copied or reproduced by any other method, in part or in full, without the prior written consent of the manufacturer of the product. The manufacturer accepts no liability for direct or consequential damages resulting from improper use, particularly where these instructions for use are not complied with. Symbols and labels The following symbols indicate notes of particular importance: Symbol

4 / 32

Hazard level

Meaning

WARNING

Failure to observe this warning can result in injury to users and patients or damage to the product or accessories.

NOTE

Particularly important contents to be taken into account when using the product.

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

2 Scope of supply

Figure 1: Scope of supply of the remOVE DC Impulse

A remOVE DC Impulse* B Foot-activated switch with connector cable C DC cable D Power cable E Test instrument for electrical tests * The front view of the remOVE DC Impulse shown may differ slightly from the actual front of the device from serial number 0225.

3 Accessories and replacement parts When purchasing accessories or replacement parts, please ensure that only original components or products that the manufacturer has indicated are compatible are used. This is the only way to ensure safety and functionality. Use of the accessories and replacement parts remOVE accessories and replacement parts, as well as the remOVE DC Cutter, may only be used in conjunction with the remOVE DC Impulse. The following accessories / replacement parts for the remOVE DC Impulse can be ordered separately: Accessories / replacement part (serial number 0010–0224) Foot-activated switch with connector cable

Max. length

Ref. no.

2m

400.03

DC cable

2m

400.04

Power cable*

2.5 m

400.10.XX

Test instrument for electrical tests**

2.2 m

810101

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

5 / 32

Accessories / replacement part (serial number ≥ 0225) Foot-activated switch with connector cable

3.5 m

400.06

DC cable

2m

400.07

Power cable*

2.5 m

400.10.XX

Test instrument for electrical tests**

2.2 m

810101

*Please specify the country when ordering the power cable. ** Observe the following warning. Test instrument only for testing purposes The test instrument is only to be used during electrical testing. – Not sterile – Not suitable for patient use – The remOVE DC Cutter Set 12 / 14 (Ref. no. 400.02.01 / 400.02.02) is not included in the scope of supply and must be ordered separately: Product

Ref. no.

remOVE DC Cutter Set 12 / 14 (includes remOVE DC Cutter, remOVE SecureCap 12 / 14, remOVE Grasper, remOVE Shield)

400.02.01 / 400.02.02

4 Product description

Figure 2: Front view of the remOVE DC Impulse

1 ON/OFF switch 2 ON/OFF indicator 3 Status display: Charge level / Ready for use / Fault 4 Foot-activated switch connection 5 DC cable connection * The front view of the remOVE DC Impulse shown may differ slightly from the actual front of the device from serial number 0225.

6 / 32

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

Figure 3: Rear view of the remOVE DC Impulse

6 Nameplate 7 Power supply connection 8 Fuse

Figure 4: Nameplate of the remOVE DC Impulse (The nameplate design may differ slightly from the above image for devices up to serial number 0224).

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

7 / 32

5 Intended use / indication The remOVE DC Impulse is a medical electrical device for the fragmentation of Ovesco OTSC® and FTRD® clips in the digestive tract. The following products contain an Ovesco clip: Product

Ref. no.

OTSC® System Set

100.01, 100.02, 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, 100.50

FTRD® System Set

200.70, 200.72, 200.76

OTSC® Proctology

200.60

Fragmentation of other objects The remOVE DC Impulse may only be used for the fragmentation of Ovesco clips. The fragmentation of other objects may result in defects on the remOVE DC Impulse, destruction of the remOVE DC Cutter and permanent connection of the remOVE DC Cutter with the object.

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

7 Complications The following complications may occur when the product is used for its intended purpose: • Damage to the tissue in the digestive tract, particularly: - Thermal damage to the wall of the digestive organ - Haemorrhages resulting from damage - Perforations – these can also arise subsequently after surgery. According to the IEC 60601-1, Section 8.7.3. A14, medical electrical devices carry “the risk of triggering ventricular fibrillation even at the lowest current intensity”.

8 / 32

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

8 General information Multiple uses of the remOVE DC Impulse The remOVE DC Impulse is designed to be used multiple times. In doing so, special cleaning measures and storage conditions must be observed (see Chapter 15 and Chapter 16.3). Damage to the remOVE DC Impulse Prior to using the remOVE DC Impulse, please check that all components are present and that there are no defects. Incomplete or faulty components must be replaced immediately. Defective or missing components may result in the product malfunctioning. For example, defective insulation on power supply lines may lead to electrocution of the patient and/or user. Use of the device in a hospital environment The characteristics of this device determined by emissions allow its use in hospitals (CISPR 11, class A). When used in a home environment (for which class B is usually required according to CISPR 11), this device may not offer sufficient protection from radio services. If necessary, the user must take corrective measures such as repositioning or realignment of the device. Use in the vicinity of active HF surgical devices Do not use in the vicinity of active HF surgical devices or equipment. Active HF surgery devices may not be used when the pulse current is in use.

9 Warnings and precautions Use in the vicinity of electrical devices Using the remOVE DC Impulse in the immediate vicinity of or stacked on other electrical devices should be avoided, as this may lead to malfunctioning. Use of the accessories provided The use of accessories, transducers (mains adapters) and cables other than those specified or provided by the manufacturer of this device may result in increased electromagnetic interference transmission or reduced electromagnetic immunity of the devices and lead to malfunctioning. Use in the vicinity of HF communication devices Portable HF communication devices (e.g. mobile phones, devices with radio function), including their accessories such as aerial leads and external aerials, should be at least 30 cm away from the components indicated by the manufacturer and the cables of the remOVE System. Failure to comply may lead to a drop in product performance. No defibrillation protection The remOVE DC Cutter Set and the remOVE DC Impulse are not defibrillation protected. The instrument must be removed from the patient before a defibrillator procedure. Ignition or explosion of flammable gases due to sparking is possible during use, e.g. at high oxygen concentration in or outside of the digestive tract. Before use, ensure that no flammable gases/materials are in the vicinity of the device or application point. Ensure that live cables/parts do not come into contact with the remOVE DC Cutter. Defective cables can cause an electric shock to the patient/user.

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

9 / 32

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 can also arise subsequently after surgery. Partially cut or truncated clips may no longer fulfil their intended purpose if left in the patient‘s body. These clips can also break, resulting in sharp-edged clip fragments that could cause damage to the organs in the digestive tract or other abdominal organs. This damage can also arise subsequently after surgery. Neuromuscular irritation is highly unlikely during use, due to the physical mechanism of action and the technical design of the system, however it cannot be completely ruled out as a matter of principle. During insertion into the oesophagus, there is always a residual risk of neuromuscular irritation, particularly of the heart muscle, as well as interference with active cardiac implants. Use in the oesophagus Please note the following before insertion into the oesophagus: - Clinically relevant disturbances of the electrolyte balance, particularly hypokalaemia, should be compensated for. A cardiologist should be consulted if necessary. - A cardiologist must be consulted for patients with implanted cardioverter defibrillators (ICDs) and consideration must be given to switching off the ICD for the duration of the procedure and under observation of the patient.

MRI safety information Compatibility of the remOVE DC Impulse with magnetic resonance imaging (MRI): Not MR Safe The remOVE DC Impulse is not MRI compatible. It must not be used in an MRI environment.

10 / 32

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

10 Components and products required for use

Figure 5: Products required for use

E

remOVE DC Impulse incl. accessories*

F

remOVE DC Cutter Set 12 / 14 (Includes remOVE DC Cutter (G), remOVE SecureCap 12/14 (H), remOVE Grasper (I), remOVE Shield (J))

Ref. no. 400.01 Ref. no. 400.02.01 / 400.02.02

* The front view of the remOVE DC Impulse shown may differ slightly from the actual front of the device from serial number 0225.

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

11 / 32

11 Preparation Additional devices connected to medical electrical devices must demonstrate their compliance with the relevant IEC or ISO standards. In addition, all configurations must conform to the normative requirements for medical systems (see IEC 60601-1-1 or section 16 of the 3rd edition of the IEC 60601-1 respectively). Any person who connects additional devices to medical electrical devices is considered a system configurator and is therefore responsible for ensuring that the system meets the normative requirements for systems. Please note that local laws take precedence over the aforementioned normative requirements. When setting up the remOVE DC Impulse, ensure that the user has unobstructed, direct view of the status display. When setting up the remOVE DC Impulse, ensure that the ambient conditions allow the user to hear the acoustic signals generated by the remOVE DC Impulse. Only connect the remOVE DC Impulse to a power supply with a protective conductor, to avoid electric shock. The following steps must be performed before use: 1.

Position the device on a stable surface at a suitable distance to the wall so that the device can be disconnected from the power supply immediately if necessary.

2.

Connect the power cable to the remOVE DC Impulse and then connect the power cable to the power supply.

3.

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

4.

Connect the remOVE DC Cutter to the DC cable.

To connect the remOVE DC Cutter with the DC cable, orient the two markings so that the white dot on the plug of the remOVE DC Cutter and the red dot on the plug of the DC cable are aligned; see figure below.

Figure 6: Left: remOVE DC Cutter. Right: DC cable

5.

Switch on the remOVE DC Impulse by pressing the ON/OFF switch. The ON/OFF indicators lights up to signal that the device is switched on.

12 / 32

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

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

Figure 7: Status display indicates the charge level during the charging phase: The LEDs flash green. The number of LEDs indicates the charging progress.

If the remOVE DC Impulse has not been in operation for more than two days, a complete charge will take approx. 10 minutes. If the remOVE DC Impulse was in operation within the last two days, the charging time may be shorter. Successful completion of the charging cycle is indicated through three short acoustic signals in quick succession. The status display indicates operational readiness through continuous illumination of all eight LEDs in green.

Figure 8: The status display indicates operational readiness: All eight LEDs are illuminated green.

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

12 Use The user must ensure that the set-up, assembly and use of the remOVE DC Impulse, all accessories and the endoscopic instrument complies with the instructions for use. Only use one DC cable to connect the remOVE DC Cutter to the remOVE DC Impulse. Proper working order of the product is no longer guaranteed if a direct connection is made without a DC cable or when a connection is made with more than one DC cable. Under certain circumstances this may also result in a defect of the remOVE DC Impulse. Ensure that the clip can be removed. If the clip is deeply embedded, measures may need to be taken to expose the surface of 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 surgery. When inserting and removing the remOVE DC Cutter, ensure that neither the endoscope nor the remOVE DC Cutter have been damaged, e.g. through kinking the instrument hose.

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

13 / 32

Winding the remOVE DC Cutter too tightly can lead to the instrument tip bending. This can make it difficult to position the instrument on the clip and to make contact with the clip during use. Before beginning the cutting process, ensure that the remOVE Shield has been affixed to the endoscope lens. 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. The tip of the remOVE DC Cutter can heat to a temperature of up to 130 °C during the cutting process. Touching the instrument tip immediately after use can lead to burns to the skin. Use in a CO2 atmosphere may reduce the effectiveness of the clip fragmentation. Even if the product is used as intended, side 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. Ensure that the foot-activated switch is not continuously actuated. A single cutting procedure is triggered only if the foot-activated switch is pressed following an acoustic contact signal. Continuous operation may lead to unintentional triggering of a cutting process. When removing residual material from the instrument tip using a DC pulse, the instrument tip must be positioned away from patients, users and other parties, as sparks may be generated. If the user has red-green visual impairment, ensure that the user understands the signal display.

Temperature compensation after storage or transport If the remOVE DC Impulse has been stored or transported at temperatures below +10 °C, it must be acclimatised at room temperature for at least 3 hours before it is used. The following steps must be observed during use: 1. Guide the endoscope to the clip to be removed. 2. Then insert the remOVE DC Cutter through the working channel and establish contact with the clip. A continuous audible signal indicates that there is sufficient electrical contact with the clip. 3. When a continuous acoustic signal sounds, trigger the cutting process by pressing the foot switch once. When the cutting process is complete, the acoustic signal stops and the status display flashes green for approx. 6 seconds. This is followed by a short acoustic signal (three tones) and the status display shows that it is ready for use.

14 / 32

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

4. To make clip removal easier, the clip should ideally be severed in two places on opposite sides of the row of teeth.

Figure 9: For the fragmentation of the chosen places on the clip: Make the first cut at (1), and the second cut on the opposite side (2).

5. After the cutting process, the remains of the clip material may be located in the instrument tip of the remOVE DC Cutter and create a conductive contact between the electrodes. This is indicated by a continuous audible signal without clip contact. The remains can be removed by applying a new DC pulse. 6. It is recommended to then withdraw the remOVE DC Cutter from the endoscope and remove the remains by pressing down on the foot switch to trigger a DC pulse. As this can lead to sparking, the instrument tip must be positioned away from patients, users or third parties. 7. Verify that the clip has successfully fragmented in two places by checking the endoscopic image. 8. Remove the endoscope and place the remOVE SecureCap over the endoscope tip. Guide the endoscope with the remOVE SecureCap to the clip fragments to be removed. 9. 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 remOVE Grasper when withdrawing the endoscope. Repeat this procedure for the second clip fragment, or, if necessary, for further clip fragments.

Figure 10: With the clip fragment gripped by the remOVE Grasper in the remOVE SecureCap

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

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

15 / 32

13 Notes on the workings of the product The remOVE DC Impulse is designed to send an electrical DC pulse, typically IS = 155 A, for a duration of 60 ms through the bipolar endoscopic remOVE DC Cutter. This DC pulse flows through the clip segment in contact with the remOVE DC Cutter and causes localised melting of the clip material.

Figure 11: Left: Contacting a clip segment with the remOVE DC Cutter. Right: Cross-section through the contacted clip segment (b) with marking of the current path IS between the electrodes (a).

The remOVE DC Impulse has an internal energy storage system that enables the rapid generation of a DC pulse after charging. This internal energy storage system is charged by the remOVE DC Impulse before generating a DC pulse. The remOVE DC Impulse is designed so that a DC pulse can only be triggered when there is sufficient contact with a clip segment. Sufficient contact is indicated by an acoustic signal. If contact between the remOVE DC Cutter and clip is broken during a DC pulse, the remOVE DC Impulse output is deactivated in less than 500 µs. Contact is broken when, for example, one or both electrodes lose contact or if the clip is successfully fragmented. During a DC pulse, there is a voltage difference between the electrodes of the remOVE DC Cutter of 1.3 V to 2.0 V. During a break in contact, higher voltages up to max. 22 V may occur for a short time (max. 500 µs). These voltages can be transferred to the tissue if both electrodes of the remOVE DC Cutter are in contact with the tissue.

14 Fault message The remOVE DC Impulse is equipped with a fault detection system. A technical fault is indicated on the status display. The fault detection system is designed to prevent risks to users or patients. The housing must not be opened in the event of a fault message on the device. A life-threatening electric shock cannot be ruled out. In order to protect users and/or patients, the device must not continue to be used in the event of a fault message. In the event of a fault, all eight LEDs on the status display flash orange; see figure below.

16 / 32

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

Figure 12: Status display flashes orange in the event of a fault.

If a fault is indicated on the remOVE DC Impulse, the acoustic contact detection between instrument and clip is deactivated. A DC pulse can no longer be triggered and the internal energy storage system of the remOVE DC Impulse is no longer charged. The manufacturer must be contacted in the event of a fault message or if the device is not working.

15 Cleaning and disinfection As part of your responsibility for the hygiene of the product components in the course of their use, always ensure that only suitable devices and product-specific validated procedures are used for cleaning and disinfection. Please observe the relevant country-specific regulations and hygiene requirements for medical practices and hospitals. Disinfection using wipes Please only use cleaning agents and disinfectants approved for cleaning surfaces as directed by the respective manufacturer. Observe any specifications relating to their concentration, temperature and exposure time. Use alcohol-based detergents and disinfectants. Do not use benzyl alcohol-based products or other agents, as these may result in damage to the materials of the remOVE DC Impulse. Instructions 1.

Prepare the cleaning agent/disinfectant according to the respective manufacturer‘s instructions.

2.

Wipe the equipment using a cloth soaked in a surface disinfectant. Begin by cleaning off heavy contamination and then give each surface a uniform clean.

3.

Wipe the surfaces. Ensure that all the surfaces are cleaned equally thoroughly. Comply with any efficacy controls prescribed by the manufacturer of the disinfectant.

4.

Moisten a sponge or cloth in clean water and wipe off the cleaning agent/disinfectant.

5.

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

6.

Check all the surfaces of the equipment with a visual inspection. If any dirt remains, repeat the entire cleaning/disinfection procedure.

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

17 / 32

Safety information Before cleaning, disconnect the remOVE DC Impulse from the power supply. Do not use flammable or explosive cleaning or disinfectant solutions. Ensure that no liquids enter the device. If these specifications are not complied with, this may result in fire and/or electric shock. Only clean and disinfect the product by hand. The product must not be sterilised under any circumstances.

16 Transport, shipping and storage conditions Transport and shipping When transporting the device, ensure that the relevant transport conditions are complied with. If the device needs to leave the hospital environment, disinfect the surfaces and pack the device separately from the shipping packaging before it leaves the hospital environment to prevent the spread of pathogens and infections. Do not damage packaging The packaging must not become damaged, wet or contaminated. Inappropriate transport or shipping may result in product damage or malfunction during use that could endanger users or patients.

Disinfecting before transport Shipping the remOVE DC Impulse in different packaging to the undamaged original packaging may result in damage to the device during transport. Ovesco shall not assume any liability for such transport damage. Storage Store the remOVE DC Impulse in a dry, clean location, taking into consideration the relevant storage conditions. We recommend storing the remOVE DC Impulse in the undamaged original packaging. Do not expose the product to direct or indirect sunlight or other UV radiation. Do not store in the vicinity of chemicals, disinfectants or radioactive radiation. Do not place any heavy objects on the product or its packaging. We recommend thoroughly cleaning the remOVE DC Impulse before storage after use. Ovesco shall not assume any liability for damage to the device due to improper storage. Observing storage conditions Improper storage may result in malfunctions during application that could endanger users or patients. Complaints will not be considered if the remOVE DC Impulse is not stored correctly.

18 / 32

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

Transport and storage conditions The following ambient conditions must be considered when transporting or storing the remOVE DC Impulse: Ambient condition

Storage

Transport

Temperature

0 °C to 50 °C

Relative humidity

0 % to 90 % RH, non-condensing 0 % to 90 % RH, non-condensing

-20 °C to +50 °C

Air pressure

500 to 1060 hPa

500 to 1060 hPa

17 Maintenance and repairs General Check the remOVE DC Impulse and its accessory components for damage or defects after every use. In particular, ensure that the insulation is intact on all cables. Do not use a damaged device or accessories. Immediately replace defective accessories. Carry out the technical safety check (TSC) on the device once per year. Technical safety check (TSC) A technical safety check must be carried out annually. Where applicable, ensure that any shorter TSC intervals prescribed at a national level are complied with. Observe the country-specific rules and regulations during the technical safety check. The device and accessory components should only be checked by individuals with the necessary training, expertise and experience and who can perform the inspection independently. The assessor documents the results of the check and the measured values in accordance with the inspection protocol from the manufacturer (see the appendix to these instructions for use). The inspection protocol is available for download from the manufacturer’s website (www.ovesco.com). The manufacturer must be contacted if serious discrepancies or anomalies are identified. Repairs Repairs to be carried out only by the manufacturer Maintenance and repair work may only be carried out by the manufacturer or by persons authorised to do so by the manufacturer. Opening the product without authorisation or having services carried out by unauthorised persons releases the manufacturer from any liability relating to the operational safety of the product or the product guarantee. In the event of repairs In the event that a repair is required, contact the manufacturer directly. Under no circumstances should you attempt repairs yourself.

Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020

19 / 32

Ovesco accepts liability for the safety, reliability and performance of the device under the following circumstances: - All the instructions relating to installation and proper use, in accordance with these instructions for use, have been strictly followed. - Modifications, repairs, etc. have been carried out only by individuals authorised by Ovesco to perform these tasks. - The electrical installation in the room concerned complies with the local regulations and legal provisions. The following information must be provided in the event of a repair request. A quick and successful repair can only be guaranteed if this information is provided in full. - Complete postal address - Reference number of the remOVE DC Impulse - Serial number of the remOVE DC Impulse - A description of the problem, how the device was being used and the accessories that were being used

18 Disposal The national requirements must be complied with when disposing of or recycling the product or its components. Symbol

Designation A product marked with this symbol must be taken to a separate collection point for electrical and electronic devices. Within the European Union, the manufacturer is responsible for disposing of the product at no charge.

19 Operating conditions The following operating conditions must be observed when using the remOVE DC Impulse: Ambient condition

Value

Temperature

+10 °C to +40 °C

Relative humidity

25 % to 75 % RH, non-condensing

Air pressure

800 hPa to 1060 hPa

Operating height

≤ 2000 m

20 Technical data Insulation / classification EMC

IEC 60601-1-2:2014

Protection class provided by housing

IP 21

Protection class provided by foot-activated switch

IPX8

Protection class according to EN 60601-1 20 / 32

II with functional earth Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020