Stryker FLUID SAFE User manual

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ES
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Manual
Manual
Manuel
Handbuch
2016/09 www.stryker.com 1000-400-948-Rev. F

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ES
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DE
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All rights reserved. This manual should not be photocopied,
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completely or in part, without the approval of STRYKER
ENDOSCOPY.
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 topoint out to us any errors or
unclarities in this manual.
Copyright © STRYKER ENDOSCOPY
Este manual contiene informaciones protegidas por el derecho
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microfilm u otros medios y procedimientos.
Debido al desarrollo constante de nuestros productos, nos reservamos
el derecho a llevar a cabo modificaciones técnicas sin aviso previo.
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Asimismo, no pueden sacarse conclusiones del presente manual, sobre
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STRYKER ENDOSCOPY cualquier aviso, indicación u observación con respecto
a posibles fallos, incongruencias o explicaciones poco claras que puedan
encontrarse en el presente manual.
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CE marking according to Directive 93/42/EEC
Identificación CE conforme a la directriz 93/42/CEE
Marquage CE conforme à la directive 93/42/CEE
CE-Kennzeichnung gemäß Richtlinie 93/42/CEE
Stryker Endoscopy
5900 Optical Court, San Jose
CA 95138 (USA)
[phone] [phone]
www.stryker.com
Model/Modelo/Série/Baureihe/
H111M111/1200483/10000019973 00/2016-09/Hahn
0197
Produced for

EN
ES
FR
DE
Symbols Símbolos Symboles Bildzeichen
Refer to instruction
manual Consulte el manual
de instrucciones
Consultez le
manuel d’utilisa-
tion
Gebrauchsanwei-
sung befolgen
Caution Peligro Danger Gefahr
Symbol for type BF
equipment
Símbolo para un
aparato del tipo BF
Symbole pour un
appareil de type BF Symbol für ein Gerät des Typs BF
Symbol for
potential
equalization
Símbolo para la co-
nexión
equipotencial
Fiche
équipotentielle Symbol für den Potentialausgleich
Degrees of protec-
tion provided by
enclosures
(IP-Code)
Grado de protec-
ciónproporcionado
por los envolventes
(Código IP)
Degrés de protec-
tion procurés par
les enveloppes
(Code IP)
Gehäuseschutz-
klasse (IP-Code)
Do not push!
¡No empujar!
Interdit de
pousser ! Schieben verboten
Alternating current Corriente alterna Courant alternatif Wechselstrom
Service Servicio Service Service
Catalog number Número de catá-
logo Numéro du cata- logue Katalognummer
Single use only No reutilizable Usage unique Nicht zur
Wiederverwedung
Do not resterilize No reesterilizar Ne pas restériliser Nicht resterilisie-
ren
Sterilized using EO Esterilizado con EO Stérilisés à l'EO Sterilisiert mit EO
Lot number Denominación
de partida o lote Numéro de lot Chargen- bezeichnung
Serial number Número de serie Numéro de série Seriennummer
Date of
manufacture Fecha de fabricación Date de fabrication
Herstellungsdatum
Use by Utilizable hasta Date limite
d'utilisation Verwendbar bis
Pieces, quantity Piezas, cantidad Pièces, quantité Anzahl, Menge
Quantity Cantidad Quantité Menge
IP 41
REF
STERILE
EO
Stück
pieces
QTY
Symbols/Símbolos/Symboles/Bildzeichen

EN
ES
FR
DE
Symbols/Símbolos/Symboles/Bildzeichen
Pictographs Símbolos Symboles Bildzeichen
Not made with
natural rubber
latex
Producto no produ-
cido con látex de
caucho natural
Ce produit ne
contient pas de
latex de caout-
chouc naturel
Nicht aus Natur-
kautschuklatex
hergestellt
Number of
autoclaving cycles
Número de
esterilizacionespor
autoclave
Paramètres pour la
stérilisation à
l'autoclave
Anzahl der
Autoklavierungen
Do not get wet Proteger contra la
humedad Protéger de l'humidité Vor Nässe schützen
Top-Bottom Arriba-abajo Haut - bas Oben - Unten
Fragile Frágil Fragile Zerbrechlich
Do not use if pack-
age is damaged No utilizar si el en- vase está dañado
Ne pas utiliser les
produits si l'embal-
lage est déterioré
Nicht verwenden,
wenn Verpackung
beschädigt ist
Keep away from
sunlight Proteger de la luz solar Protéger des rayons du soleil Vor Sonnenlicht schützen
On/Off Encendido/
Apagado Marche/Arrêt Ein/Aus
Start/Stop Inicio/Parada Start/Stop Start/Stopp
Menu Menú Menu Menü
Down symbol Decreciente Décroissant Abnehmend
Up symbol Creciente Croissant Zunehmend
Overpressure Sobrepresión Surpression Überdruck
Reset key Tecla puesta
en cero Touche de remise à zéro Reset-Taste
Deficit rate alarm Alarma déficit Alarme déficit Defizitraten-Alarm
Non sterile No estéril Non stérile Nicht steril
UL Symbol Símbolo UL Symbole UL UL-Symbol
Waste
Management Gestión de residuos Élimination des déchets Entsorgung
LATEX
FREE
134 °C
3 bar
5 min
xx
NON
STERILE

EN
ES
FR
DE
Pictographs Símbolos Symboles Bildzeichen
Power connected
Conectado a la red
eléctrica Réseau d'alimenta- tion raccordé Netz angeschlos- sen
Manufacturer Fabricante Fabricant Hersteller
Stryker European
Representative Representante europeo de Stryker Représentant Stryker Europe Vertretung in Europa
This product con-
tains Diethylhe-
xylphthalate
(DEHP)
Este producto con-
tiene dietilhexilfta-
lato (DEHP)
Ceproduitcontient
du diéthylhexyl-
phtalate (DEHP)
Dieses Produkt ent-
hält Diethylhe-
xylphthalat (DEH)
Authorized for Sale
or use by Physician
only
Autorizado sólo
para la venta o el
uso médico
Autorisé seule-
ment pour la vente
ou l’utilisation par
un médecin uni-
quement
Nur für autorisier-
tes Vertriebsperso-
nal oder Arzt
EC
REP
Symbols/Símbolos/Symboles/Bildzeichen

Contents
EN
1 Important User Notes ........................................................................................................................................................... 1
2 Safety Notes .......................................................................................................................................................................... 2
2.1 Dangers and Risks ...................................................................................................................................................................... 3
3 Purpose of the Device ........................................................................................................................................................... 5
3.1 Device-inherent Dangers ......................................................................................................................................................... 6
4 Initial Use of the Device ........................................................................................................................................................ 9
4.1 Mains Connection ...................................................................................................................................................................... 9
4.2 Electromagnetic Compatibility ...............................................................................................................................................10
4.3 Guidelines and Manufacturer's Statement - Electromagnetic Emissions .................................................................11
4.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity .........................................11
4.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity
- for the FLUID SAFE Fluid Management System ...............................................................................................................12
4.6 Recommended Safety Distances Between Portable and Mobile HF Telecommunications Devices
and the FLUID SAFE Fluid Management System ...............................................................................................................13
4.7 Assembly of the Device Combination ...................................................................................................................................14
5 Operating the Device ............................................................................................................................................................18
5.1 Device Front .................................................................................................................................................................................18
5.2 Rear of the Device .......................................................................................................................................................................19
5.3 Inserting the Tube Set ...............................................................................................................................................................20
5.4 Switch on Device .........................................................................................................................................................................22
5.5 Starting and Stopping Pump Operation ..............................................................................................................................24
5.6 Presetting the Nominal Pressure ...........................................................................................................................................24
5.7 Actual Pressure Display ............................................................................................................................................................24
5.8 Presetting Nominal Flow ..........................................................................................................................................................25
5.9 Volume Display ...........................................................................................................................................................................25
5.10 Instrument Detection ................................................................................................................................................................25
5.11 Functions of the Display Unit ..................................................................................................................................................26
5.12 Bag and Container Recognition ..............................................................................................................................................27
5.13 Launching/Configuring the User Menu ...............................................................................................................................28
5.14 Weighing Unit .............................................................................................................................................................................29
5.15 Turning Device Off .....................................................................................................................................................................30
6 Safety Functions ...................................................................................................................................................................31
7 Function Test ........................................................................................................................................................................32
7.1 Preparing the Function Test ....................................................................................................................................................32
7.2 Performing the Pump Unit Function Test ...........................................................................................................................33
7.3 Performing the Balancing Unit Function Test ....................................................................................................................33
7.4 Performing Function Test for Instrument Detection (ID) ...............................................................................................33
7.5 Ending the Function Test .........................................................................................................................................................33
8 Use of the Device during Surgery .........................................................................................................................................34
9 Care and Maintenance ..........................................................................................................................................................35
9.1 Mechanical Component Check ...............................................................................................................................................35
9.2 Cleaning the Device ...................................................................................................................................................................35
9.3 Cleaning the Reusable Tube Set .............................................................................................................................................35
9.4 Disinfecting the Reusable Tube Set .......................................................................................................................................35
9.5 Sterilization of Reusable Tube Set .........................................................................................................................................36
9.6 Manufacturer's Specifications ................................................................................................................................................36
9.7 Maintenance by Authorized Service Technician ...............................................................................................................36
9.8 Replacing the Fuse .....................................................................................................................................................................37
10 Annual Inspection .................................................................................................................................................................38
10.1 Safety Test ....................................................................................................................................................................................38
10.2 Basic Function Test ....................................................................................................................................................................39
10.3 Pressure Measuring Test ..........................................................................................................................................................40
10.4 Pressure Sensor Test ..................................................................................................................................................................41
10.5 Test of the Weighing Unit ........................................................................................................................................................41
11 Accessory List ........................................................................................................................................................................42
12 Technical Data ......................................................................................................................................................................43
13 Error and Warning Messages ...............................................................................................................................................44
14 Glossary ................................................................................................................................................................................48
15 Appendix ...............................................................................................................................................................................49
15.1 Test Record ...................................................................................................................................................................................49
15.2 Warranty .......................................................................................................................................................................................50
15.3 Service and Claims .....................................................................................................................................................................50
16 Index .....................................................................................................................................................................................51

Important User Notes
1
EN
1 Important User Notes
Read the manual carefully and become familiar with the operation and function
of the device and the accessories before use during surgical procedures.
Non-observance of the manual can lead to
• 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 the product.
Please noteThe words DANGER, WARNING and NOTE carry special meanings and they should
be read attentively. Please read this manual completely and follow its
instructions carefully.
The safety and/or health of the patient, user, or a third party is at risk. Comply
with this warning to avoid injury to the patient, user, or third party.
These paragraphs contain information concerning the intended and proper use
of the device or accessory.
Here you will read information about the maintenance of the device or the
accessories.
DANGER
WARNING
NOTE

Safety Notes
2
EN 2SafetyNotes
U.S. federal law
(Only U.S. market) U.S. law stipulates that this device be used only by a physician or under
supervision of a physician.
No liability The manufacturer does not accept any liability for direct or consequential
damages if
• the device or the accessories are used improperly,
• the instructions and rules in the manual are not adhered to,
• the device or the accessories are improperly prepared and maintained,
• non-authorized persons perform repairs, adjustments or alterations to the
device or accessories,
• non-authorized persons open the device,
• the prescribed inspection and maintenance schedules are not adhered to.
Receiving technical documentation from the manufacturer does not authorize
individuals to perform repairs, adjustments, or alterations on the device or
accessories/peripherals.
Caution: No modification of this equipment is allowed.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or
alterations on the device or accessories and use the service menu.
Noncompliance will render the manufacturer’s warranty null and void.
Authorized service technicians are only trained and certified by the
manufacturer.
Intended use This device should be used only in compliance with its intended use.
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. Therefore, test
function and completeness after every service or maintenance activity to ensure
the safety of the patient and user/surgical team are not affected or diminished
in any way.
Brand-new products, as well as repaired products, must be prepared and tested
prior to use.
Contamination Before shipping, decontaminate device and accessories in order to protect
service personnel and to ensure safe transportation of the device. Follow the
instructions listed in this manual.
If this is not possible,
• the product must be clearly marked with a contamination warning and
• double-sealed in safety foil.
The manufacturer has the right to refuse carrying out repairs if the product is
contaminated.
Waste management This symbol indicates that the waste of electrical and electronic equipment must
not be disposed as unsorted municipal waste and must be collected separately.
Please contact the manufacturer or other authorized disposal company to
decommission your equipment.

Safety Notes
3
EN
2.1 Dangers and Risks
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
determine the specific technique and procedure that will accomplish the desired
clinical effect.
Factory settings
Check all factory settings. Factory settings are not mandatory settings for the
physician. The physician is responsible for all settings affecting the surgical
procedure.
Original accessories
For your own safety and that of your patient, use only original accessories.
Not explosion-proof
The device is not explosion-proof. Do not use in an area where flammable
anesthetic gases are present.
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device
yourself. Refer servicing to qualified service personnel.
Professional qualification
This manual does not include descriptions or instructions for surgical
procedures/techniques. It is also not intended to introduce to or train physicians
in the use of surgical techniques. Medical accessories and devices may be used
only by physicians and medical assistants under the direction of a physician with
the appropriate technical/medical qualification.
Function test
The function test must be performed prior to each operation.
Sterile mediums and accessories
Always work exclusively with sterile substances and mediums, sterile fluids and
sterile accessories.
Disposal of irrigation fluid
Comply with local hygiene rules and regulations when disposing off the
irrigation fluid.
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER

Safety Notes
4
EN Replacement device and accessories
In case the device or any of the accessories fail during an operation, a
replacement device and replacement accessories should be kept within easy
reach to complete the initiated surgical procedure safely.
Device-inherent dangers
Read the warnings specific to this device in chapter 3.1 Device-inherent Dangers,
page 6.
Device defect
If a device defect is suspected or confirmed, do not use the device. Make sure the
device can no longer be used until a qualified service technician conducts the
appropriate tests and repairs.
Replacing fuse
Replace the fuse only with a fuse of the same type and rating.
Maintenance and calibration
Do not open the device. The device may not be opened or calibrated by the
user/operator. Only authorized service technicians are permitted to repair,
calibrate, or modify the device or its equipment.
Available mains voltage
Check to make sure that the available mains voltage matches the data listed on
the label attached to the back of the device (type plate). Incorrect voltage can
cause errors and malfunctions and may destroy the equipment.
Condensation / water penetration
Protect device from moisture. Do not use if moisture or liquid has penetrated the
device.
Cleaning the device
Do not sterilize the device.
DANGER
DANGER
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

Purpose of the Device
5
EN
3 Purpose of the Device
Intended useThe device is an irrigation pump with a balancing system for hysteroscopies. It is
used to introduce fluids into the uterine cavity. The device may not be used for
other endoscopic procedures. The stand and balancing system may only be used
with the accompanying pump.
IndicationsThe device is indicated for liquid distension of the uterus for diagnostic and
operative hysteroscopic procedures, and monitoring the volume differential
between the irrigation fluid flowing into and out of the uterus. Please comply
with the specific indications and instructions provided in the manual of your
endoscope.
ContraindicationsThe device may not be used to introduce fluids into the uterine cavity when a
hysteroscopy is contraindicated. See the operators manual of your hysteroscope
for absolute and relative contraindications. Relative contraindications to
endometrial ablation:
Surgical skill („Acute Technical“).
Hysteroscopic endometrial ablation, whether by laser or electrosurgery, should
not be undertaken before adequate training, preceptorship, and clinical
experience. Additionally, tissue sampling is required prior to destruction of the
endometrium. The following are clinical conditions that can significantly
complicate hysteroscopic endometrial ablation:
• Adenomatous endometrial hyperplasia
• Uterine leiomyoma
• Severe adenomyosis
• Pelvic pain (subtle PID)
• Uterine anomalies
Relative contraindications to hysteroscopic myomectomy:
• Surgical skill (see above)
• Severe anemia
• Inability to circumnavigate the myoma (re: myoma size)- predominantly
intramural myomas with small submucous components.
Technical application scope of the device The nominal pressure can be preset to ranges between 15 to 100 mm Hg and 100
to 150 mm Hg. The nominal flow can be preset to between 30 and 500 ml/min.
Pressure measuring and regulatingThis device features non-contact pressure readings of the irrigation medium. The
non-contact pressure reading is taken by integrating the pressure chamber into
the tube system. The pressure chamber transfers the tube pressure to the
device’s processing unit via two pressure sensors. The pressure control circuit
continuously compares the actual pressure with the nominal pressure. The
function of the device is to maintain the nominal pressure. If the nominal flow is
set too low, the nominal pressure cannot be reached. Check for possible leaks.

Purpose of the Device
6
EN 3.1 Device-inherent Dangers
The volume of the irrigation fluid entering and leaving the patient has to be
strictly monitored. When using an irrigation fluid with a low viscosity, a volume
in excess of 2 liters poses an increased risk of dangerous bacteria entering the
patient's body. The procedure should be continued only with increased vigilance.
When using an irrigation fluid with a high viscosity (e.g. Hyskon), an increased
risk of dangerous bacteria entering the patient's body exists already at only 500
ml. Please consult the user notes and instructions for Hyskon to obtain
additional information.
The pressure should be kept as low as possible to allow for a sufficient
intrauterine distension and to reduce the forces that could allow fluid, ambient
air, and/or gas into the circulatory system.
A intrauterine distention is usually possible with pressure values between 35 to
70 mm Hg. A pressure above 75 to 80 mm Hg is required only in rare cases or if
the patient has an excessively high blood pressure.
In accordance with its design purpose, the pump may be used without balancing
system only for diagnostic purposes. Pay attention to the indications for the
pump unit in the separate handbook.
Fluid Overload (Hypotone Hyperhydration)
By passing through the uterus, irrigation fluid could reach the blood system or
the patient’s tissue. This could happen in the cases of overpressure, a lengthy
operation, or a perforation of the uterine cavity. The resulting disruption of the
electrolyte balance could cause TUR syndrome. The doctor bears responsibility
for the monitoring and assessment of the mentioned factors.
The decision to use the instrument detection is at the discretion of the physician.
The irrigation pressure is displayed if the instrument detection function is not
performed or the STOP key is pressed during operation. The status of the
instrument detection function cannot be displayed or loaded during surgery.
The instrument recognition may only be performed outside of the patient and at
a height of ± 10 cm (± 3.94 inches) to the height of the uterus (operation’s
height).
Follow the instructions and order required to perform the instrument detection
exactly as described to prevent the display of false actual values.
Stop the device using the Start/Stop switch if replacing the instrument during
surgery.
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER
DANGER

Purpose of the Device
7
EN
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
vacuum being generated inside of the bottle. Risk of implosion.
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.
Set up the device in such a way as to allow for easy monitoring of the display
values, device functions, and access to the control elements.
Position the device such that it is easy to operate and disconnect.
Endoscope
The device may only be connected with endoscopes designed for and featuring
the technical specification permitting such a combined use. Any utilized
endoscopes must comply with the most recent versions of EC 60601-2-18 and
ISO 8600.
The device can tilt, if unauthorized or unsuitable bags or containers are used, or
if a load on one side is too heavy.
Balancing error
The complete system is composed of the weighing system and the stand system,
each of which include their own components. The individual components may
not touch one another, in order not to compromise exactness of measurement.
Please pay attention that the bag, tubes, container, equipotential cable and
other parts of the weighing system do not come into contact with the pump unit,
the carrier plate, the unit-carrying frame and the roller base. Pay attention that
the load controller and its O-ring do not touch the scale pole. The secretion
containers must hang freely and may not be damaged in any way.
Make sure that neither the mains cable nor the equipotential cable touch the
scale system. The device may only be operated with angular equipotential MC
plugs.
Fluid volume/Sodium concentration
It is necessary to monitor the fluids left in the patient and the concentration of
sodium in the blood serum. The total fluid volume the device has lost is the
deficit amount. Take note of the measurement tolerance of the system.
Estimating the fluid volume remaining in the patient is the doctor’s
responsibility.
DANGER
DANGER
DANGER
WARNING
WARNING
DANGER
DANGER
DANGER
DANGER

Purpose of the Device
8
EN Filling of the tube and resetting the display are to be done at the doctor’s
discretion. When using the balancing system, follow the exact operating
instructions in this manual. Should the pump be used without the balancing unit
for diagnostic purposes, the corresponding handbook is to be consulted without
fail.
The deficit and inflow values are lost in case of a power loss or „brownout“.
Please pay attention that the containers hang freely and are not supported or in
contact with anything from below, otherwise the weight necessary for
balancing cannot be accurately ascertained.
Do not use this device if a defect is suspected or detected during the function
check. This also applies to obvious defects, especially defects and damage of the
power plug and power cable.
Electrical interference
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 suspect 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.
DANGER
DANGER
DANGER
DANGER
WARNING

Initial Use of the Device
9
EN
4 Initial Use of the Device
Input controlAlways check all parts and accessories of the device immediately after receiving
the shipment. Inspect for external damage as well. The manufacturer considers
only replacement claims that have been immediately submitted or reported to a
sales representative or an authorized service company.
SetupInstall the device on a level surface and in a dry environment. The ambient
temperature has to be between 10°C and 40°C; the relative humidity has to be
between 30% and 75%.
The device is not explosion-proof. Do not use in an area where flammable
anesthetic gases are present.
4.1 Mains Connection
Check to make sure that the available mains voltage matches the data listed on
the label attached to the back of the device (type plate). Incorrect voltage can
cause errors and malfunctions and may destroy the equipment.
Make sure the mains power supply is installed in compliance with DIN VDE or
international rules and regulations. The power cord must be plugged into a
properly installed safety wall plug (see DIN VDE 0107). Read the device label
located in rear of device (type plate) to determine the operating voltage of the
device.
Protective contactTo avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
The power connection has to be grounded. Use the original power cable to
establish a connection between the mains wall socket and the non-heating
device plug located in the rear of the device.
Only for U.S. operatorsOnly use a certified (UL listed), removable mains connection line, type SJT,
minimal 18 AWG, 3 leads. The plugs have to comply with NEMA 5-15 and/or IEC
320/CEE22. Grounding will only be reliable if the equipment is connected to a
corresponding hospital grade socket.
Potential equalizationIntegrate the device into the potential equalization system as specified by local
safety rules and regulations.
Make sure that neither the mains cable nor the equipotential cable touch the
scale system. This could lead to an error in balancing. The device may only be
operated with angular equipotential MC plugs.
DANGER
WARNING
WARNING
DANGER

Initial Use of the Device
10
EN 4.2 Electromagnetic Compatibility
Protective measures Medical devices are subject to special precautionary measures concerning
electromagnetic compatibility (EMC). This device is to be used only for the
purposes described in the manual and has to be installed, set up, and operated in
compliance with the EMC notes and instructions.
4.2.1 Impact of Mobile and Portable HF Communication Devices
The emission of high frequency energy by mobile communication devices may
affect the function of the electrical medical device. Operating such devices (e.g.,
cell phones, GPS phones) in the proximity of the electrical medical device is
prohibited.
4.2.2 Electrical Connections
Do not touch electrical connections identified with this warning label. Do not
establish a connection between these plugs and sockets without first
implementing precautionary ESD (electrostatic discharge) measures.
Precautionary ESD measures The following are ESD precautionary measures:
• Apply potential equalization (PE) to all devices to be connected.
• Use only the listed equipment and accessories.
Employees have to be informed about and trained in ESD precautionary
measures.

Initial Use of the Device
11
EN
4.3 Guidelines and Manufacturer's Statement - Electromagnetic Emissions
The FLUID SAFE Fluid Management System is intended for use in an environment as described below. The user/operator of the
FLUID SAFE Fluid Management System should make sure the device is operated within such an environment.
4.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity
The FLUID SAFE Fluid Management System is intended for use in the electromagnetic environment specified below. The
user/operator of the FLUID SAFE Fluid Management System should make sure the device is operated within such an environment.
*Note: UT is the mains alternating voltage before applying the test levels.
Emitted interference
measurements Compliance Electromagnetic environment guidelines
HF emission according to
CISPR 11
Group 1 The device FLUID SAFE Fluid Management System uses high
frequency energy only for its internal functions. Therefore,
its HF emission is very low and it is unlikely that devices in
close proximity will experience any interference.
HF emission according to
CISPR 11
Class B The FLUID SAFE Fluid Management System is suitable for
use in all facilities including those in residential areas and
those directly connected to a public utility network also
supplying buildings used for residential purposes.
Emission of harmonic oscillations
according to IEC 61000-3-2
Class A
Emission of voltage fluctuations /
flickers according to
IEC 61000-3-3
In compliance
Electromagnetic interference
immunity tests
IEC 60601 test level Compliance Electromagnetic environment
guidelines
Discharge of static electricity
(ESD) according to
IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
In compliance Floors should be made of wood or
concrete or feature ceramic tiles. If
the floor covering consists of
synthetic material, the rel. humidity
should be at least 30%.
Fast electrical transients /
bursts according to
IEC 61000-4-4
± 2 kV for AC power lines
± 1 kV for input and output
lines
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment.
Surges according to
IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode voltage
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment.
Blackouts, brownouts, and
fluctuations of the power
supply according to
IEC 61000-4-11
< 5% UT*(>95% dip in UT) for
½ cycle
40% UT(60% crash of the UT)
for 5 periods
70% UT(30% crash of the UT)
for 25 periods
<5% UT (>95% dip in UT)
for 5 s
In compliance The quality of the supply voltage
should be the same as the voltage of
a typical business or hospital
environment. If the user/operator of
the FLUID SAFE Fluid Management
System requires the continuation of
functionality after power
interruptions/disruptions, it is
recommended to provide the FLUID
SAFE Fluid Management System with
power from an uninterruptible
power supply.
Supply frequency magnetic
field (50/60 Hz) acc. to
IEC 61000-4-8
3 A/m In compliance Magnetic fields of the mains power
frequency should comply with the
typical values of business and
hospital environments.

Initial Use of the Device
12
EN 4.5 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity - for the FLUID SAFE Fluid
Management System
Note 1: The higher frequency range applies at 80 MHz and 800 MHz.
Note 2: These guidelines are probably not realizable in all cases. The distribution and spread of electromagnetic quantities differs
depending on the absorption and reflection of buildings, objects, and people.
a The field strength of stationary transmitters such as base stations of mobile phones and land mobile devices, ham radio
stations, AM and FM radio, and TV broadcasters are theoretically not 100% predictable. A site study is recommended to
determine the electromagnetic environment as it pertains to the stationary transmitters. If the measured field strength at the
proposed FLUID SAFE Fluid Management System installation and operation site exceeds the concordance levels listed above, the
FLUID SAFE Fluid Management System should be monitored to document proper functionality and operation as intended.
Additional measures might become necessary, e.g., modifying orientation or a different location for the FLUID SAFE Fluid
Management System if unusual performance characteristics are observed.
bThe field strength should be less than 3 V/m for the frequency range of 150 kHz to 80 MHz.
Electromagnetic interference
immunity tests
IEC 60601 test level Compliance Electromagnetic environment
guidelines
Conducted RF interference
quantities according to
IEC 61000-4-6
Radiated RF interference
quantities according to
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
In compliance
In compliance
Portable and mobile wireless devices
should not be used in closer
proximity to the FLUID SAFE Fluid
Management System (including
cables/lines) than the recommended
safety distance calculated based on
the transmitting frequency and the
applicable formula. Recommended
safety distance:
d= 1.2 √P for 150 kHz to 80 MHz
d = 1.2√P for 80 MHz to 800 MHz
d = 2.3 √P for 800 MHz to 2.5 GHz
With Pas the rated output of the
transmitter in watts [W] according to
the information provided by the
manufacturer of the transmitter and
das recommended safety distance in
meters [m].
The field strength of stationary
transmitters should remain lower for
all frequencies than the concordance
level tested on sitea. bInterference is
possible in the proximity of devices
featuring the following pictograph.