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Instructions for use
English
Ref. No. 400.01
remOVE DC IMPULSE
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remOVE DC Impulse
Instructions for use
Revision 08
Date 2019-04-24
For remOVE DC Impulse
Version 2.XX
Ref No.: 400.01
Ovesco Endoscopy AG
Friedrich-Miescher-Straße 9
72076 Tuebingen
Germany
+49 7071 98979 160
service@ovesco.com
www.ovesco.com
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Contents
1 About this document ............................................................................4
2 Components .........................................................................................5
3 Accessories / replacement parts ..........................................................6
4 Description ...........................................................................................6
5 Intended use / indication ......................................................................7
6 Contraindications .................................................................................8
7 Complications .......................................................................................8
8 Warnings / precautions.........................................................................9
9 Components and products required for use ....................................... 11
10 Preparation ......................................................................................... 12
11 Use of product .................................................................................... 14
12 Mode of operation .............................................................................. 17
13 Error message ................................ ................................ .................... 18
14 Cleaning and disinfection ................................................................... 18
15 Transport and shipping / storage ........................................................ 20
16 Maintenance / repair .......................................................................... 21
17 Disposal ............................................................................................. 23
18 Operating conditions .......................................................................... 23
19 Specifications ..................................................................................... 23
20 Electromagnetic compatibility (EMC) ................................................. 25
21 Warranty ............................................................................................. 28
22 Symbols ............................................................................................. 29
Appendix 1 .................................................................................................. 30
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Instructions for use
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English; Version 08 | 2019-04-24
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
Friedrich-Miescher-Straße 9
72076 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.
1.1 Symbols and labels
The warning symbols used in these instructions for use depict the following hazard
levels.
Symbol
Hazard level
Meaning
WARNING
Failure to observe this warning notice may
result in injury to users and patients.
INFORMATION
Particularly important contents to be taken
into account when using the product.
2 Components
A
remOVE DC Impulse
B
Foot-activated switch with connector cable
C
DC cord
D
Power cord
Test instrument for electrical tests
Figure 1: Components of the remOVE DC Impulse (Ref. No. 400.01)
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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
2 m
400.03
DC cord
2 m
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.
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
Ref. no.
remOVE DC Cutter Set 12 / 14 (remOVE
DC Cutter, remOVE SecureCap 12 / 14,
remOVE Grasper, remOVE Shield)
400.02.01 / 400.02.02
4 Description
1
ON/OFF switch
2
ON/OFF display
3
Status display: charge of battery / ready for use / error
4
Connection foot-activated switch
5
Connection DC cord
Figure 2: Front view of the remOVE DC Impulse
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6
Name plate
7
Connection to power supply
8
Fuse
Figure 3: Rear view of the remOVE DC Impulse
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
100.01, 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
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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.
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
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).
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8 Warnings / precautions
Multiple use of the remOVE DC Impulse
The remOVE DC Impulse is designed for multiple use. In doing so,
special cleaning measures and storage conditions are to be observed
(see chapter 14 and section 15.3).
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. Faulty or missing components may result in the product
malfunctioning. For example, flawed insulation on power supply lines may lead
to electrocution of the patient and/or user.
Use of the device in the 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 conversion or realignment of the device.
Use in the vicinity of active HF surgery devices
Do not use in the vicinity of active HF surgery devices. Active HF surgery devices
may not be used when the pulse current is in use.
Use in the vicinity of electrical devices
Use of 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 components, transducers (mains adapters) and cables other than
those specified or provided by the manufacturer of this device can result in increased transient electromagnetic emissions 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.
MRI compatibility of the remOVE DC Impulse
The remOVE DC Impulse is not MRI compatible. It must not be used in an MRI
environment.
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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.
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 sharpedged 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 oesophagus 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
oesophagus:
- 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 cardiolo-
gist 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.
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9 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
remOVE DC Impulse incl. accessories
Ref. No. 400.01
F
remOVE DC Cutter Set 12 / 14 (remOVE DC
Cutter, remOVE SecureCap 12 / 14, remOVE
Grasper, remOVE Shield)
Ref. No. 400.02.01/
400.02.02
Figure 5: Products required for use
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10 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 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. As soon as all eight green LEDs are constantly on, the remOVE DC Impulse
is ready for use.
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11 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.
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.
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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 sec-
ond cut on the opposite side (2)
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
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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. Turn off the remOVE DC Impulse by pressing the ON/OFF switch.
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12 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.
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.
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13 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.
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.
14 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.
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14.1 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.
14.2 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.
14.3 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.
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15 Transport and shipping / storage
15.1 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.
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.
15.2 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.
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15.3 Transport and storage conditions
When transporting or storing the remOVE DC Impulse, please make sure that the
following environmental requirements are met:
Environmental factors
Storage
Transportation
Temperature
0 °C to +50 °C
-20 °C to +50 °C
Relative humidity
0 % to 90 %, RH
non-condensing
0 % to 90 %, RH
non-condensing
Air pressure
500 to 1060 hPa
500 to 1060 hPa
16 Maintenance / repair
16.1 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.
16.2 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.
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16.3 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:
- 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.
- Electrical installations in the space concerned are in accordance with local
and national rules and regulations.
In your repair request, please include the following information. Correct and complete information ensures quick and successful repair work.
- Complete address
- Order number of remOVE DC Impulse
- Serial number of remOVE DC Impulse
- Describe the problem, the act of use when the problem occurred and all
accessories used.
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17 Disposal
When disposing or recycling the product or its components, please make sure to
follow national rules and regulations.
18 Operating conditions
When using the remOVE DC Impulse, please make sure the following operating
conditions are met:
Environmental factors
Value
Temperature
+10 °C to +40 °C
Relative humidity
25 % to 75 % RH non-condensing
Air pressure
700 to 1060 hPa
Operation level
≤ 4000 m
If the remOVE DC Impulse has been stored or transported at a temperature of less
than + 10 °C, it must be acclimated to room temperature for at least 3 hours.
19 Specifications
Isolation / Classification
EMC
IEC 60601-1-2:2014
Type of protection, through casing
IP 21
Type of protection, through foot-activated switch
IPX8
Type of protection according to EN 60601-1
II with functional earth
Type of applied part according to 60601-1
BF
Compliance with standards
IEC 60601-1: 2005+Cor.: 2006 +Cor.:
2007 + A1 2012
IEC 60601-1-2: 2014
IEC 60601-1-6:2010
ISO 14971: 2007
ISO 13485: 2003 + AC 2009
Classification according to 93/42/EEC
IIb
Symbol
Description
Products with this symbol have to be delivered to a separate collection for electrical and electronic equipment. Inside the European Union, the manufacturer will dispose of the product free of
charge.
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Power input
100V–230 V
Power supply voltage
220V–230 V
100 V–120 V
Power consumption in standby mode once fully
charged
6 W / 17 VA
6 W / 10 VA
Power consumption in standby mode
60 mA
90 mA
Max. power consumption
50 W / 55 VA
50 W / 50 VA
Mains fuse
T 0.8 A H 250 V
T 0.8 A H 250 V
Line frequency
50 / 60 Hz
50 / 60 Hz
Measurements and weight
Measurements of product
340 x 340 x 110 mm
Net weight
5.0 kg
Type of packaging / measurements
Carton 400 x 400 x 300 mm
Gross weight
7.5 kg
Operating conditions
State of charge
Indicated by green flashing LEDs on status display.
Ready for use initial
Indicated by three short acoustic signals in quick succession
and continuous glowing of all LEDs on status display in
green once operating voltage is reached. Initial charge when
device energy storage is completely discharged takes ca. 10
minutes.
Ready for use signal
Indicated by three short acoustic signals in quick succession
once operating voltage is reached or 6 seconds after DC
pulse.
Ready for use visual
Indicated by all LEDs on the status display being lit in green.
On/Off signal
Yes. Green LED display above on/off switch.
Overheating protection
Yes.
Error message
Yes. All LEDs are flashing orange on status display.
Documentation
Log and record of number of uses
Yes. Readout by qualified personnel only.
Specifications
Instrument type remOVE DC Cutter
Bipolar / direct current
One-time duration of impulse during activation
≤ 65 ms
Output current remOVE DC Cutter
≤ 165 A
Output voltage remOVE DC Cutter
1.3–2.0 V
Interval between activations
≥6 s
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Compatibility
remOVE DC Cutter Set 12 / 14
Art.-Nr. 400.02.01 / 400.02.02
Foot-activated switch
Art.-Nr. 400.03
DC cord
Art.-Nr. 400.04
Power cord
Art.-Nr. 400.10.XX
Environmental conditions for operation,
transport and storage
Operation
Storage
Transportation
Temperature
+10 °C to +40 °C
0 °C to +50 °C
-20 °C to +50 °C
Relative humidity
25 % to 75 % RH,
non-condensing
0 % to 90 % RH,
non-condensing
0 % to 90 % RH,
non-condensing
Air pressure
700 to 1060 hPa
500 to 1060 hPa
500 to 1060 hPa
Operation level
≤ 4000 m
-
-
20 Electromagnetic compatibility (EMC)
Make sure no electronic devices which could be compromised by electromagnetic
fields are present in the vicinity of the remOVE DC Impulse. A compromised device
could lead to malfunction and/or failure of respective device and thus may endanger user and/or patient.
Medical electrical equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided in
the accompanying documents.
Guidance and manufacturer’s declaration
Electromagnetic emissions
The remOVE DC Impulse is intended for use in the electromagnetic environment specified below. The customer or the user of the remOVE DC Impulse should assure that it is used in such
an environment.
Measurements of electromagnetic emissions
Compliance
RF emissions CISPR11
Group 1
RF emissions CISPR11
Class A
Harmonic emissions IEC 61000-3-2
not applicable
Voltage fluctuations / flicker emissions IEC 61000-3-3
complies
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Guidelines and manufacturer's declaration
Electromagnetic immunity
The remOVE DC Impulse is designed for use in an electromagnetic environment as specified below. The user must ensure that the device is operated in such an environment.
Compatibility test
IEC 60601 test level
Compliance level
Electrostatic discharge (ESD) according to IEC 61000-4-2
± 8 kV contact discharge
± 8 kV contact discharge
± 2,4,8 and 15 kV air
discharge
± 2,4 and 8 kV air discharge
Fast transient elec. disturbance
values/bursts according to IEC
61000-4-4
± 2 kV for power cables
± 2 kV power cables
Surges according to 61000-4-5
± 0.5 kV, ± 1 kV line to line
voltage
± 0.5 kV, ± 1 kV line to line
voltage
± 0.5 kV, ± 1 kV, ± 2 kV
line to earth voltage
± 0.5 kV, ± 1 kV, ± 2 kV line
to earth voltage
Short interruptions according to
IEC 61000-4-11
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT; 1 cycle and 70 %
UT; 25/30 cycles
single phase: at 0°
0 % UT; 1 cycle and 70 %
UT; 25/30 cycles
single phase: at 0°
Voltage dips according to IEC
61000-4-11
0 % UT; 250/300 cycle
0 % UT; 250/300 cycle
Power frequency magnetic field
(50/60 Hz) according to IEC
61000-4-8
30 A/m
30 A/m
Please note: UT is the mains voltage prior to applying the test level.
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Guidelines and manufacturer's declaration
Electromagnetic immunity
The remOVE DC Impulse is designed for use in an electromagnetic environment as specified
below. The user must ensure that the device is operated in such an environment.
Compatibility test
IEC 60601-1-2: 2014-02
test level
Compliance level
HF conducted disturbances according
to IEC 61000-4-6
3 V
150 kHz to 80 MHz
6 V a) in ISM bands between 0.15 MHz and 80
MHz
10 V
HF radiated disturbances according to
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz b)
80 % AM at 1 kHz
3 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
a)
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to
40.70 MHz.
b)
Test specifications for immunity of the housing to wireless telecommunications devices:
Test frequency
(MHz)
Band (MHz)
Use
Modulation
Max.
power
(W)
Distance
(m)
Immunity
test level
(V/m)
385
380-390
TETRA 400
Pulse modulation
18 Hz
1.8
0.3
27
450
430-470
GMRS 460,
FRS 460
FM
± 5 kHz deviation
1 kHz sine
wave
2
0.3
28
710
704-787
LTE band 13,
17
Pulse modulation
217 Hz
0.2
0.3
9
745
780
810
800-960
GSM 800/900,
TETRA 800, iDEN 820,
CDMA 850,
LTE band 5
Pulse modulation
18 Hz
2
0.3
28
870
930
1,720
1,700-1,990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE
band 1, 3, 4,
25; UMTS
Pulse modulation
217 Hz
2
0.3
28
1,845
1,970
2,450
2,400-2,570
Bluetooth,
WLAN, 802.11
b/g/n, RFID
2450, LTE
band 7
Pulse modulation
217 Hz
2
0.3
28
5,240
5,100-5,800
WLAN 802.11
a/n
Pulse modulation
217 Hz
0.2
0.3
9
5,500
5,785
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21 Warranty
Ovesco Endoscopy AG, the manufacturer, grants a 24 months warranty on material
and construction of the remOVE DC Impulse, starting from date of purchase.
The warranty covers any faults occurring in the product due to the materials used
in the manufacturing process or faulty installation by the manufacturer. Faults the
manufacturer is notified of within the warranty period will be fixed free of charge.
The warranty is void if the buyer or non-authorized third parties have interfered with
the device. The warranty does not cover defects due to incorrect handling, use,
storage, transport, force majeure or other external forces.
All other warranty claims are excluded.
Faults corrected under the manufacturer’s warranty will not engender any incidental
expenses. Shipping costs inside the Federal Republic of Germany will be borne by
the manufacturer or distributor.
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22 Symbols
CE-mark and identification number of Notified Body
See instructions for use
Caution: please observe
Serial number
Reference number
Date of manufacture
Manufacturer
When operating this device, electric energy is used, resulting in electromagnetic radiation.
Protection class II device with functional earth
ON/OFF switch
Ready for use
Connection foot-activated switch
DC cord connection
Applied part type BF
Do not use if packaging is damaged
Air pressure limit
Air humidity limitation
Temperature limitation
Marking of electrical and electronic equipment according
to applicable guideline 2012/19/EU (WEEE), see disposal
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Appendix 1
Inspection sheet
Annual technical safety control
Make sure the DC Cord is correctly plugged into the generator.
Do not press the foot-activated switch while testing the device.
Ensure that country-specific regulations and requirements, which include the generally accepted technical standards, as well as valid regulations for occupational safety and accident prevention, will be implemented and complied with during setup, operation and maintenance.
Device: remOVE DC Impulse
Safety classification: II
Article no.: 400.01
Type of applied part: BF
Serial no.:
Equipment:
☐ Inspection before initial start-up (refer-
ence value)
☐ Repeated inspection
☐ Inspection after maintenance
☐ Foot-activated switch
☐ DC Cord
☐ Power cord
☐ Test Instrument for electrical tests
1. Electrical tests (The tests must be executed
when the device is fully charged)
Result
1.1 Are all cable insulations intact?
Insulation must be intact
☐ passed ☐ failed
☐ annex, where appropriate
1.2 Insulation resistance according to the standard
EN 62353:2014 figure 4
☐ passed ☐ failed
☐ annex, where appropriate
1.3 Direct measurement for the device leakage
current according to the standard EN
62353:2014 figure 7
☐ passed ☐ failed
☐ annex, where appropriate
1.4 Direct measurement of the leakage current of
the applied part according to the standard EN
62353:2014 figure 10
☐ passed ☐ failed
☐ annex, where appropriate
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2. Operational test
Result
2.1 Are all components available?
Components must be complete
☐ passed ☐ failed
☐ annex, where appropriate
2.2 Do all LEDs light up correctly? (On/Off display,
status display)
All LEDs must light up according to the in-
structions for use.
☐ passed ☐ failed
☐ annex, where appropriate
2.3 Is the successful completion of the charging
cycle indicated by three short acoustic signals?
Completion of charging cycle must be indi-
cated by three short acoustic signals
☐ passed ☐ failed
☐ annex, where appropriate
Defects/Comments:
Overall evaluation:
☐ No Safety or functional defects were detected.
☐ No direct risk, the detected defects can be fixed shortly.
☐ The device has to be withdrawn from use until the defects are corrected.
☐ The device does not meet the requirements – Modifications/Replacement of com-
ponents/removal from service is recommended.
Contact the manufacturer if there is any deviation, abnormality and/or an indication of error.
The next inspection should be carried out after 12 months.
Name of the inspector
Date / signature
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CE-marking according to
EC directive 93/42 EEC
Ovesco Endoscopy AG
Friedrich-Miescher-Straße 9
72076 Tuebingen
Germany
phone: +49(0)7071-96528-160
fax: +40(0)7071-96528-260
e-mail: service@ovesco.com
website: www.ovesco.com
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