Ovesco remOVE DC Impulse User manual

Instructions for use
English
Ref. no. 400.01

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
[phone]
[email protected]
www.ovesco.com

Contents
1How to use these instructions for use .................................................................................................4
2Scope of supply...................................................................................................................................5
3Accessories and replacement parts....................................................................................................5
4Product description .............................................................................................................................6
5Intended use / indication .....................................................................................................................8
6Contraindications ................................................................................................................................8
7Complications......................................................................................................................................8
8General information.............................................................................................................................9
9Warnings 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

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Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020
1How 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
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.

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2Scope 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.
3Accessories 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)
Max. length
Ref. no.
Foot-activated switch with connector cable
2 m
400.03
DC cable
2 m
400.04
Power cable*
2.5 m
400.10.XX
Test instrument for electrical tests**
2.2 m
810101

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Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020
Accessories / replacement part (serial number ≥ 0225)
Foot-activated switch with connector cable
3.5 m
400.06
DC cable
2 m
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
4Product 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.

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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).

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Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020
5Intended 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.
6Contraindications
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.
7Complications
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”.

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8General 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.
9Warnings 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.

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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.