Richard Wolf FLUID CONTROL Lap 2216 User manual

en
Manual
FLUID CONTROL Lap 2216

RICHARD WOLF GmbH
Pforzheimer Straße 32
75438 Knittlingen, Germany
www.richard-wolf.com
CE-Marking according to directive 93/42/EEC
Type: P106
10000021595 01/2020-11/TR
Manufacturer:
GA-A 276 /en/2020-11 V3.0
This manual contains information that is subject to copyright. All
rights reserved. This manual should not be photocopied, duplica-
ted on microfilm or otherwise copied or distributed, completely
or in part, without the approval of RICHARD WOLF GmbH.
We reserve the right to technical changes without prior notification due to
thecontinuous further development of our products. Function or design may
partially differ from the description in the manual. Please contact us for addi-
tionalinformation about this or any of our other products.
Some of the parts and equipment referred to in this manual bear registered
trademarks but are not identified as such. It should therefore not be assumed
that the absence of the trademark indicates that any given designation is not
subject to trademark protection.
Users of this product should not hesitate to point out to us any errors or un-
clarities in this manual.
Copyright © RICHARD WOLF GmbH
en

en
Symbols
Symbols Description
Follow instructions for use
(white image on a blue
background)
Consult instructions for use
Caution
Type BF applied part
Equipotentiality
Degrees of protection pro-
vided by enclosures (IP-
Code)
Alternating current
Service
Catalogue number
Non sterile
Do not resterilize
Do not reuse
Sterilized using ethylene
oxide
Batch code
Serial number
Herstellungsdatum
(JJJJ-MM-TT)
Verwendbar bis
(JJJJ-MM-TT)
Quantity
Number of autoclaving
cycles
Keep dry
Not made with phthalates
Contains DEHP
Top-Bottom
Fragile
Waste management
Manufacturer
Authorized for Sale or use
by Physician only
Suction
Irrigation
Keep away from sunlight
Pro tect from heat a nd
radioactive sources
Recyclablepackaging
(Green dot symbol)
Symbols Description Symbols Description
Temperature limit
Humidity limitation
Atmospheric pressure limi-
tation
Do not use if package is
damaged
Recycling PAP PE
Non-ionizing electro-
magnetic radiation
Protective earth (Ground)
Input/Output
No hazardous substances
contained in the device
Air Out
RFID tag. general

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Table of Contents
1 Important User Notes ......................................................................................................................................................... 3
2 General Safety Notes .......................................................................................................................................................... 4
3 General Information ........................................................................................................................................................... 5
3.1 Device Description ................................................................................................................................................................... 5
3.2 Used as Intended and Contraindications .......................................................................................................................... 5
3.2.1 Intended Use.............................................................................................................................................................................. 5
3.2.2 Contraindication....................................................................................................................................................................... 5
3.3 General Warnings and Precautions .................................................................................................................................... 5
3.3.1 General Warnings .................................................................................................................................................................... 5
3.3.2 Precautionary Measures......................................................................................................................................................... 11
4 Device Startup..................................................................................................................................................................... 13
4.1 Delivery Scope ........................................................................................................................................................................... 13
4.2 Setting up and Connecting the Device............................................................................................................................... 13
4.3 Mounting the Pump ................................................................................................................................................................ 15
4.3.1 Mounting on Stand.................................................................................................................................................................. 16
4.3.2 Mounting on Device Cart....................................................................................................................................................... 17
4.4 Front of the Device................................................................................................................................................................... 17
4.5 Rear of the Device .................................................................................................................................................................... 18
5 Operating the Device.......................................................................................................................................................... 19
5.1 Function test.............................................................................................................................................................................. 19
5.1.1 Preparing the Function Test .................................................................................................................................................. 19
5.1.2 Irrigation Test ............................................................................................................................................................................ 19
5.1.3 Suction Test................................................................................................................................................................................ 20
5.2 Use of the Device During Surgery........................................................................................................................................ 20
5.3 Overview of the Usable Tube Sets....................................................................................................................................... 21
5.4 Inserting a Tube Set ................................................................................................................................................................. 22
5.5 Connecting the Irrigation Fluid Bags.................................................................................................................................. 25
5.6 Irrigation ..................................................................................................................................................................................... 25
5.7 Suction......................................................................................................................................................................................... 26
5.8 Replacing the Suction Container ......................................................................................................................................... 27
5.9 Removing a Vacuum Tube System....................................................................................................................................... 27
6 Safety Functions.................................................................................................................................................................. 28
6.1 Pressure Limitation at 400 mmHg ...................................................................................................................................... 28
6.2 Motor Cutout at 500 mmHg................................................................................................................................................. 28
6.3 Device Self-Test ......................................................................................................................................................................... 28
7 Care and Maintenance........................................................................................................................................................ 29
7.1 Cleaning the Device................................................................................................................................................................. 29
7.2 Care and Maintenance of Reusable Tube Set ................................................................................................................... 29
7.2.1 Cleaning the Reusable Tube Set ........................................................................................................................................... 29
7.2.2 Disinfecting the Reusable Tube Set..................................................................................................................................... 29
7.2.3 Sterilizing the Reusable Tube Set......................................................................................................................................... 30
7.3 Care and Maintenance of Reusable Tube Sets ................................................................................................................. 30
7.3.1 Cleaning Reusable Tube Sets................................................................................................................................................. 30
7.3.2 Disinfecting Reusable Tube Sets .......................................................................................................................................... 31
7.3.3 Sterilizing Reusable Tube Sets .............................................................................................................................................. 32
7.4 Annual Inspection .................................................................................................................................................................... 33
7.5 Maintenance by Authorized Service Technician.............................................................................................................. 33
7.6 Changing the Fuse ................................................................................................................................................................... 34
8 Annual Inspection ............................................................................................................................................................... 35
8.1 Safety Test................................................................................................................................................................................... 35
8.2 Irrigation Test ............................................................................................................................................................................ 35
8.3 Suction Test................................................................................................................................................................................ 36
9 Technical Data..................................................................................................................................................................... 37
10 Accessory List ...................................................................................................................................................................... 39
11 Electromagnetic Compatibility........................................................................................................................................... 40
11.1 Impact of Mobile and Portable HF Communication Devices....................................................................................... 40
11.2 Electrical Connections............................................................................................................................................................. 40
11.3 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions .............................................................. 40
11.4 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity ........................................ 41
11.5 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity ........................................ 42
12 Error and Warning Messages.............................................................................................................................................. 44
13 Test Record .......................................................................................................................................................................... 46
13.1 Test Log........................................................................................................................................................................................ 46
13.2 Return Form ............................................................................................................................................................................... 47
14 Glossary............................................................................................................................................................................... 48
Index.................................................................................................................................................................................... 49

Important User Notes
3
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1ImportantUserNotes
Read the instructions for use carefully and become familiar with the operation
and function of the device and the accessories before use during surgical proce-
dures. Non-observance of the instructions listed in this manual can lead
• to life-threatening injuries of the patient,
• to severe injuries of the surgical team, nursing staff or service personnel, or
• to damage or malfunction of device and/or accessories.
Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and
technical data of the product through continued development of its products.
Please noteThe words WARNING, CAUTION, and NOTE carry special meanings. Sections
marked with these words must be given special attention.
DANGER!
The safety and/or health of the patient, user, or a third party are at risk. Comply
with this warning to avoid injury to the patient, user, or third party.
WARNING!
These paragraphs include information provided to the operator concerning the
intended and proper use of the device or accessories.
NOTE!
These paragraphs contain information to clarify the instructions or provide addi-
tional useful information.

4
General Safety Notes
en 2 General Safety Notes
Federal Law (only for U.S. market) CAUTION: Federal Law restricts this device to sale by or on the order of a physi-
cian.
Exclusion of liability The manufacturer is not liable for direct or consequential damages, and the war-
ranty becomes null and void if:
• the device and/or the accessories are improperly used, prepared, or main-
tained;
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the de-
vice or accessories;
• unauthorized persons open the device;
• the prescribed inspection and maintenance schedule is not adhered to.
The handing over of technical documents does not constitute authorization to
make repairs or alterations to the device or accessories.
WARNING: Modifying the device FLUID CONTROL Lap 2216 is not permitted.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or al-
terations on the device or accessories and use the service menu. Any violation will
void the manufacturer's warranty. Authorized service technicians are only
trained and certified by the manufacturer.
Care and maintenance The service and maintenance of the device and its accessories has to be carried
out as per instructions to ensure the safe operation of the device. For the protec-
tion of the patient and the operating team, check that the device is complete and
functional before each use.
Maintenance of the device may not be performed during the operation.
Contamination Before shipping, decontaminate device and accessories in order to protect the
service personnel. Follow the instructions listed in these Instructions for Use. If
this is not possible,
• the product must be clearly marked with a contamination warning and
• must be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
Disposal
This symbol indicates that the waste of electrical and electronic equipment must
not be disposed as unsorted municipal waste and must be collected separately.
For disposal of the device and its accessories, please consult the manufacturer or
an authorized disposal company, in compliance with legal or national regula-
tions.

General Information
5
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3GeneralInformation
3.1 Device Description
The device FLUID CONTROL Lap 2216 is a pump with an irrigation and suction
function for laparoscopy.
The device itself is non-invasive and designed for use in multi-unit racks (non-
sterile area). It pumps medical sterile irrigation fluid through a sterile tube. This
flushes the corresponding fluids into the body cavity. The device can be used with
electrolyte-free media (such as glycine 1.5% or sorbitol 3.0%) and with isotonic
electrolyte-containing media (such as saline 0.9% or Ringer's Lactate solution).
The device is equipped with a vacuum suction function used to suction off secret-
ed fluids. The secretion liquid is sucked through a tube into the container. The de-
vice functions only with the tube sets described in the accessory list (see chapter
10 "Accessory List").
Essential PerformanceThe essential performance of the device in the laparoscopy indication consists of
providing an irrigation pressure to produce an irrigation flow. Another key per-
formance characteristic of the device is to provide suction pressure to suction the
fluid from the patient.
3.2 Used as Intended and Contraindications
3.2.1 Intended Use
The device FLUID CONTROL Lap 2216 is a suction and irrigation pump for Mini-
mally Invasive Surgeries (MIS). It flushes fluid into and suctions fluid from the ab-
domen.
3.2.2 Contraindication
Do not use the device FLUID CONTROL Lap 2216 for procedures where a specific
pressure has to be preset and reached such as a hysteroscopy or an arthroscopy.
3.3 General Warnings and Precautions
3.3.1 General Warnings
DANGER!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
DANGER!
Do not use this system if a defect is suspected or detected during the function
check. This also applies to obvious defects, especially defects and damage to the
power plug and power cord.
DANGER!
Device Errors
Do not use this device if a defect is suspected or detected during the function
check. It is prohibited to use the device in the case of obvious defects.
DANGER!
An authorized service technician must check the device if the specified parame-
ters and tolerances are exceeded.

6
General Information
en DANGER!
Do not touch
Avoid touching the roller wheel. Risk of injury!
DANGER!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient
and determine if the use of this device is indicated. The physician must deter-
mine the specific technique and procedure that will accomplish the desired clin-
ical effect.
DANGER!
Professional qualification
The Instructions for Use do not include descriptions or instructions for surgical
procedures/techniques. It is not suitable for training physicians in the use of sur-
gical techniques. Medical peripherals and devices may be used only by physi-
cians or medical assistants with the appropriate technical/medical qualifications
working under the direction and supervision of a physician.
DANGER!
Original accessories
For your own safety and that of your patient, use only original accessories.
DANGER!
Make sure the tubes for the suction-irrigation instrument do not have any kinks
when installed. Make sure the tubes are not crimped or clamped off.
DANGER!
Hygiene filter
Use a new filter for each patient. Please use a hydrophobic filter between patient
and device suction. The filter prevents bodily fluids from entering the inside of
the device and possible contaminants from the device reaching the patient.
DANGER!
Replacement device and accessories
In case the device or any of the accessories fail during surgery, a replacement de-
vice and replacement accessories should be kept within close proximity to be
able to finish the operation with the replacement components.
DANGER!
Keep full fluid bags ready for use
Always keep a full fluid bag on hand to replace an empty one. This avoids having
to interrupt surgery due to a lack of irrigation fluid.

General Information
7
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DANGER!
Sterile mediums and accessories
Always work exclusively with sterile substances and mediums, sterile fluids, and
sterile accessories if so indicated.
DANGER!
Reprocessing of sterile disposable products
Infection hazard for patients and/or users and impairment of product function-
ality due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product! Do not reprocess the product.
DANGER!
Sterilize reusable instruments and tubing before surgery to prevent infections.
Check all the single-use/disposable items before removing them from the pack-
age to ensure that the packaging is intact and that the expiration date is still val-
id.
DANGER!
Contamination
Do not use device and/or accessories if signs of contamination are detected.
Make sure the device or/and accessories can no longer be operated until a qual-
ified service technician conducts the appropriate tests and repairs.
DANGER!
Device defect
If a device defect is suspected or confirmed, do not use it. Make sure the device
can no longer be used until a qualified service technician conducts the appropri-
ate tests and repairs.
DANGER!
Disconnect device from power supply
Pressing the ON/OFF key does not disconnect the device from the power supply.
This requires pulling the plug located in the rear of the device.
DANGER!
Replacing fuse
Replace the fuse only with a fuse of the same type and rating.
DANGER!
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device your-
self. Refer servicing to qualified service personnel.
DANGER!
Cleaning the device
Do not sterilize the device.

8
General Information
en DANGER!
The product may be used only by doctors or health care professional in accor-
dance with the intended use. Personnel must have training that qualifies them
to operate laparoscopy pumps. In addition, personnel must read the user manual
and operating instructions and become familiar with handling the device before
first use. Personnel must have mastered handling and operation of the product
before first use during a surgery. This user manual does not include descriptions
or instructions for surgical procedures/techniques. It is also not intended to in-
troduce to or train physicians in the use of surgical techniques.
DANGER!
The vacuum tube sets for this device contain diethylhexylphthalate (DEHP),
which is classified as toxic to reproduction according to the EU Directive 1272/
2008/EEC on Classification, Labeling and Packaging of Dangerous Substances.
DEHP may impair fertility and may cause harm to the unborn child. Therefore,
this product must not be used for unauthorized applications. When applied
within the intended use, the potential risk to pregnant or breastfeeding women
as well as to children resulting from the DEHP contained in this product is not
critical.
DANGER!
Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environ-
ments.
DANGER!
Falls and crashes
Place the device on a stable and level surface. Cables must be laid safely. Tubes
between the device and the patient must not create any obstruction.
DANGER!
Set up the device in such a way as to allow for easy monitoring of the display val-
ues, device functions, and access to the control elements.
DANGER!
Position the device in such a way that it is easy to operate and switch off.
DANGER!
Risk of electrical shock
To avoid the risk of electrical shock, only use this device when connected to a
properly grounded power supply network.
DANGER!
Use only parts and/or devices from ME systems (see chapter 14 "Glossary") in pa-
tient environments in compliance with the standard IEC 60601-1 in the respec-
tive currently valid version

General Information
9
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DANGER!
Connect only items, that have been specified as part of the ME system or speci-
fied as being compatible with ME systems.
DANGER!
Please read the instruction manual for the stand before mounting the pump on
the stand.
DANGER!
The position of the device on the stand can affect the stand's stability. If the de-
vice is mounted too high on the stand, the stand may tilt or topple. The user/op-
erator of the device is responsible for making sure the device cannot be tipped
over or otherwise become unstable.
DANGER!
Please read the instruction manual for the device cart before mounting the
pump on the cart.
DANGER!
The device is only intended for use with flexible fluid containers. Do not use glass
containers as they might break. Fluid cannot flow quickly enough due to the vac-
uum being generated inside of the bottle. Risk of implosion.
DANGER!
Functional test
The functional test must be performed prior to each surgery.
DANGER!
Sterilize reusable instruments and tubing before surgery to prevent infections.
Check all the single-use/disposable items before removing them from the pack-
age to ensure that the packaging is intact and that the expiration date is still val-
id.
DANGER!
The irrigation fluid bags must not be stored on the device or hung up directly
above the device.
DANGER!
Select an irrigation fluid suitable for the subsequent medical procedure.
DANGER!
Checking the warning signals
The warning signals must be checked prior to each operation. The system is to be
set up so that all warning signals can be perceived.

10
General Information
en DANGER!
The reusable tube set is made of silicone, polysulfone (PSU), and stainless steel.
For cleaning and disinfection, use only pH-neutral or slightly alkaline cleaning
agents (e.g. neodisher MediClean 2.0 %), disinfectants (e.g. Lysetol V 8 %), and
drying and rinsing agents approved for the tube set materials.
Using unsuitable agents (e.g. neodisher MediKlar rinsing agent) may damage
the tube system and especially the PSU connectors.
DANGER!
Always check the reusable tube set for signs of deterioration before use and after
sterilization. Never use a tube set which shows signs of deterioration, including
cracking, or perforation.
DANGER!
Make sure to connect tubes as indicated by the matching connection pieces (con-
nectors).
DANGER!
The day tube remains connected to the device after each surgery. The patient
tube must be disposed of immediately after surgery. A new sterile cap (included
with the patient tube) must be screwed onto the hygiene connector at the day
tube after each surgery. This sterile protector remains connected to the day tube
until the next surgery.
DANGER!
Do not touch patient and the ON/OFF switch at the same time.
DANGER!
Serum sodium concentration
It is also necessary to monitor the concentration of sodium in the blood of the pa-
tient to prevent electrolyte disturbances. Monitoring of the concentration of so-
dium in the blood must be performed by the physician and is not performed or
supported by the system.
DANGER!
Air Embolisms
An air embolism can be the result of air contained in the tube set or connected
instrument reaching the patient. Make sure that there is always fluid in the bag
to prevent air from being aspirated into the patient.

General Information
11
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DANGER!
Additional equipment
Additional equipment connected to medical electrical devices must be demon-
strated to be compliant with their respective IEC or ISO standards (IEC 60601-1,
IEC 60950 or IEC 62368 for data processing equipment). Furthermore, all config-
urations must comply with the normative requirements for medical systems (see
section 16 of the last valid edition of IEC 60601-1). Anyone who connects addi-
tional devices to medical electrical equipment is a system configurator and as
such is responsible for the system's compliance with the normative require-
ments for systems. Please contact the technical service if you have additional
questions.
DANGER!
Hypothermia (monitoring body temperature)
The continuous flow of the distension liquid may lower the body temperature of
the patient. Lower body temperatures can cause coronary and cardiovascular
problems. Always monitor the patient's body temperature during the entire sur-
gical procedure. Make especially sure that the following, hypothermia promot-
ing, operation conditions are avoided as best as possible:
• longer operating times
• use of cold irrigation fluid.
3.3.2 Precautionary Measures
WARNING!
The pressure chamber diaphragm is fragile and can be replaced if damaged. Re-
placement diaphragms are supplied with reusable tubes. The reusable tube sets
must be prepared before each use. See chapter 7.2 Care and Maintenance of Re-
usable Tube Set for further instructions.
WARNING!
Connecting the tube
The tube outlet may only be connected to instruments which are intended for in-
tra-abdominal fluid suction and irrigation.
WARNING!
The day tube must be replaced at the end of the day of surgery but not later than
after 24 hrs.
WARNING!
The indicated drying time depends on several variables, including the following:
Altitude, humidity, type of packaging, preconditioning, size of chamber, mass of
load, and placement in chamber. Users must verify that the drying time set in
their autoclave yields dry surgical equipment when using the method of saturat-
ed steam sterilization described here.
WARNING!
Connecting the tube
The tube outlet may only be connected to instruments which are intended for in-
tra-abdominal fluid suction and irrigation.

12
General Information
en WARNING!
Patient group
There are no restrictions as to the specification of the patient group when using
the device as intended and its use does not endanger the patient's health.
WARNING!
Electrical Interference
(See chapter 11 "Electromagnetic Compatibility"). Electrical interference with
other devices or instruments was practically eliminated when developing this
devices and none was detected during testing. However, if you still detect or sus-
pect such interference, please follow these suggestions:
• Move this, the other or both devices to a different location
• Increase distance between used devices
• Consult an electro-medical expert
WARNING!
Use of other accessories, other transducers and cables
The use of accessories, transducers, and cables other than those specified, with
the exception of transducers and cables sold by the MANUFACTURER of the ME
EQUIPMENT or ME SYSTEM (see Chapter 14 "Glossary") as replacement parts for
internal components, may result in increased EMISSIONS or decreased IMMUNI-
TY of the ME EQUIPMENT or ME SYSTEM.
WARNING!
Power cables
Any power cables employed by the user that are not provided by the manufac-
turer must meet the safety requirements of the national standards in the respec-
tive current valid version.
WARNING!
Service connection
Access to the service menu is restricted to authorized service personnel.The con-
nected equipment must comply with the standard EN 60950 in the currently val-
id version. Do not connect a device to the service connection during surgery.

Device Startup
13
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4 Device Startup
DANGER!
The product may be used only by doctors or health care professional in accor-
dance with the intended use. Personnel must have training that qualifies them
to operate laparoscopy pumps. In addition, personnel must read the user manual
and operating instructions and become familiar with handling the device before
first use. Personnel must have mastered handling and operation of the product
before first use during a surgery. This user manual does not include descriptions
or instructions for surgical procedures/techniques. It is also not intended to in-
troduce to or train physicians in the use of surgical techniques.
NOTE!
Locations
The device is only to be used in a professional facility healthcare enviroment.
4.1 Delivery Scope
• Device FLUID CONTROL Lap 2216
• InstructionsforUse
• Powercord
Delivery inspectionAlways check all parts and accessories of the device immediately after receiving
the shipment. The manufacturer considers only replacement claims that have
been immediately submitted or reported to a sales representative or an autho-
rized service company.
Returning the deviceIf it becomes necessary to return the device, always use the original packaging.
The manufacturer does not take responsibility for damage that has occurred dur-
ing transportation if the damage was caused by inadequate transport packaging.
Please fill out the return form enclosed at the end of the instructions. Enclose the
manual with the device.
Please make sure that all required information has been supplied:
•Nameofowner
• Address of owner
• Device type and model
• Serial number (see identification plate)
• Description of defect
4.2 Setting up and Connecting the Device
Setting upPlace the device on a flat surface free of vibration located in a dry environment.
The ambient temperature and humidity must meet the requirements mentioned
in Chapter 9 "Technical Data".
DANGER!
Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environ-
ments.
DANGER!
Falls and crashes
Place the device on a stable and level surface. Cables must be laid safely. Tubes
between the device and the patient must not create any obstruction.

14
Device Startup
en DANGER!
Set up the device in such a way as to allow for easy monitoring of the display val-
ues, device functions, and access to the control elements.
DANGER!
Position the device in such a way that it is easy to operate and switch off.
DANGER!
Risk of electrical shock
To avoid the risk of electrical shock, only use this device when connected to a
properly grounded power supply network.
DANGER!
Use only parts and/or devices from ME systems (see chapter 14 "Glossary") in pa-
tient environments in compliance with the standard IEC 60601-1 in the respec-
tive currently valid version
WARNING!
The ME device is suitable for arrangement in ME device systems (see chapter14
"Glossary"). Operation of the ME device in close proximity to non-ME devices
may result in the intended use of the ME device no longer being guaranteed.
WARNING!
Equipment should be positioned such that power cord can be easily disconnect-
ed.
WARNING!
Ventilation of the device
Avoid device overheating. Ensure free air circulation especially to the bottom
and rear of the device (rear panel distance of at least 10 cm).
WARNING!
Before switching on the device, sufficient time must have passed to adjust to the
indoor climate.
WARNING!
Place the device outside the sterile field.
WARNING!
Position of the user
To avoid a malfunction, the user must be positioned correctly
• for observation up to 2 m from the front of the device.

Device Startup
15
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Power connection
WARNING!
Check to make sure the available mains voltage matches the data listed on the
type label attached to the back of the device. Incorrect voltage can cause errors
and malfunctions and may destroy the device.
Make sure the connection data and technical specifications of the power supply
comply with DIN VDE or national requirements. The mains connection cable
must be plugged into a properly installed, grounded shockproof safety wall sock-
et.
Protective contactThe power connection must be equipped with ground contact (protective con-
tact). Use the original power cable (included in scope of delivery) to establish a
connection between the mains wall socket and the mains socket located in the
rear of the device.
WARNING!
To avoid the risk of electrical shock, only use this device when connected to a
properly grounded power supply network.
Potential equalizationThe equipotential bonding is used as a protective measure against the failure of
the protective conductor according to requirements of IEC 60601-1 in the respec-
tively valid version. The installation must be according to the relevant local safety
regulations.
4.3 Mounting the Pump
The device is designed to be suspended from a portable stand or for upright
placement on a device cart.

16
Device Startup
en 4.3.1 Mounting on Stand
DANGER!
Please read the instruction manual for the stand before mounting the pump on
the stand.
NOTE!
Make sure the rod of the stand has a diameter of 20-30 mm.
DANGER!
The position of the device on the stand can affect the stand's stability. If the de-
vice is mounted too high on the stand, the stand may tilt or topple. The user/op-
erator of the device is responsible for making sure the device cannot be tipped
over or otherwise become unstable.
1. Slide the pump onto the rod of the stand at the desired height. Please pay at-
tention to sufficient stability.
2. Tighten the toggle screw on the rear of the pump.
Abb. 4-1 Mounting on the stand
h