PFM Medical EWF 600 User manual

Operating Manual
pfm Forceps EWF 600
Please read this operating manual
carefully before using the instrument
for the first time and make certain
that you are familiar with the method
of operation as well as the instrument’s
operating elements to ensure that it
is used in the correct way.
www.pfmmedical.com
Quality and Experience

2pfm Forceps EWF 600 Rev. 2022-04-01
Note
Serial number:
Please enter the serial number of your instrument here.It can be found on the nameplate.
Dear Customer,

time and make certain that you are familiar with the method of operation as well as the
instrument’s operating elements to ensure that it is used in the correct way.
All the information in this operating manual applies to the pfm Forceps EWF 600.
Note

3pfm Forceps EWF 600 Rev. 2022-04-01
Part 1 – Safety instructions 4
1.1 Key to symbols 4
1.2 Intended purpose 6
1.3 User group/user profile 6
1.4 Protective devices 6
1.5 Operating the instrument 6
1.6 General precautions 7
Part 2 – Introduction 8
2.1 View of the pfm Forceps EWF 600 8
2.2 Technical data for the pfm Forceps EWF 600 8
2.3 Scope of delivery 8
Part 3 – Operating instructions 9
3.1 Transportation, unpacking and setting up 9
3.2 Initial operation 10
3.3 Initial recharging of the batteries 10
3.4 Display 11
3.5 Temperature setting 11
3.6 Illumination of the working area 11
3.7 Forceps battery level 12
3.8 Connection signal strength 12
3.9 Menu settings 12
3.10 Factory settings 13
3.11 Replacing the forceps tips 13
3.12 Malfunctions and their correction 13
Part 4 – Maintenance, cleaning and care 14
4.1 Maintenance 14
4.2 Cleaning and care 14
4.3 Cleaning and care of touch screen/display 14
4.4 Returning the pfm Forceps EWF 600 for repair or maintenance 15
4.5 Decontamination 15
4.6 Instrument fuse 15
4.7 Warranty 16
4.8 Declaration of Conformity 16
Part 5 – Accessories 17
Part 6 – Disposal of the pfm Forceps EWF 600 when put out of use 18
Contents

4pfm Forceps EWF 600 Rev. 2022-04-01
Part 1 – Safety instructions
Please read this operating manual carefully before working with the pfm Forceps EWF 600. Make
certain that you are familiar with the instrument‘s controls and method of operation.Always
observe the following precautions during operation of the instrument. Failure to do so is contrary
to the recognised technical regulations and the intended use of the instrument.
In case of infringement, pfm medical ag does not accept any form of liability.
Safety instructions
1.1 Key to symbols
Caution! This symbol indicates a possible danger to life and health.Failing to observe these instruc-
tions can result in severe health impacts, including life-threatening injuries.
Indicates useful information
Indicates a dangerous situation
NOTE
WARNING
Manufacturer
Date of manufacture
Consult operating manual
PLEASE NOTE The up-to-date electronic operating manual can be found on our website:
http://www.pfmmedical.com/downloads
In vitro diagnostic (IVD) medical device
IVD
Catalogue number
REF
Serial number
SN
CE marking

5pfm Forceps EWF 600 Rev. 2022-04-01
Safety instructions
Biohazard warning
The instrument must not be disposed of in normal domestic waste.
It must be collected separately.
Hot surface warning
Dangerous electrical voltage warning
Permissible temperature range at the place of use
+10°C - +40°C
Permissible temperature range for storage and transportation
-10°C - +50°C
Permissible humidity range for storage and transportation, and at the place of use
10% - 80% (non-condensing)
10°C
40°C
-10°C
50°C
10%
80%
Keep dry
Fragile, handle with care
UN3480 – Lithium-ion batteries
UN 3480
Phone:

6pfm Forceps EWF 600 Rev. 2022-04-01
1.2 Intended purpose

forceps for safe transfer and alignment of human and animal
tissue specimens during embedding in the histological

can be used as a diagnostic aid related to an in-vitro
examination within the histopathological process and
may only be operated by appropriately trained personnel.
The product facilitates the preparation of tissue samples
which,after further processing, are diagnosed by a pathologist
and provide information on the physiological or pathological
condition.
1.3 User group/user profile
The pfm Forceps EWF 600 must only be operated by

instrument's method of operation.

manual must be read so that the user is familiar with the
method of operation and the operating controls.This is
essential to ensure proper handling.
NOTE
The operating manual should be accessible to everyone.
Safety instructions
1.4 Protective devices
Temperature control and monitoring of the forceps tip via
a wireless connection signal
Connection signal strength indicator
WARNING
Caution! Protective devices must not be removed from the instrument or modified.
The proper functioning of the protective devices must be checked by the user before starting work.
Only use suitable accessories and connecting cables
recommended/supplied by pfmmedical.
Only operate the instrument from power outlets with an
earth conductor.
The external fuse protection must not exceed 16 A.
If the instrument fuse needs to be replaced,the parameters

Observe all warnings.
Warnings on the instrument must not be removed or
obscured.
Do not start up the instrument if it is damaged.
Do not start up the instrument if it has a damaged mains
power cable.
The mains power cable must not come into contact with
the hot forceps tips.
Do not place the forceps on hot surfaces.
Do not open the instrument housing/forceps.
Do not remove the batteries
The instrument must only be opened and repaired by
service technicians trained and authorised by pfmmedical.
For servicing and repair work, the instrument must be

No corrosive, acidic or alkaline solutions should be used
in the vicinity of the instrument, as they could cause
corrosion and damage the instrument and accessories.
1.5 Operating the instrument

7pfm Forceps EWF 600 Rev. 2022-04-01
Please take special note of the following warnings:
1.6 General precautions
WARNING
Caution! Warns of dangerous electrical
voltage.
WARNING
Caution! Warns of a hot surface. The
forceps tips can be very hot in
operating mode.
Beware of explosive gases
The instrument must not be used if dangerous gas
concentrations could occur in the surrounding area.
Risk of infection
When working with infectious materials,appropriate
safety measures must be implemented.The samples used
may potentially be infectious.The general laboratory rules
regarding protection against infections must therefore be
observed.
Risk of radioactivity
When working with radioactive materials, the radiation
protection regulations must be followed. Protective clothing
must be worn in accordance with the rules and regulations
that apply in your laboratory for handling radioactively
contaminated materials.For the disposal of radioactive waste,
the applicable regulations will apply in each instance.
Avoiding malfunctions
To avoid malfunctions,the instrument must not be used
close to radio transmitters, e.g. mobile phones. If the

your dealer.
Caution

please check that the supply voltage/frequency at the place

Protective earthing of the instrument
To avoid the risk of electrocution, the instrument must be
properly connected to an earth conductor.The instrument
is equipped with a mains power plug with earth conductor
(protection class I). It is very important to check that the
mains power outlet used is equipped with an earth
conductor, and that it complies with the regulations of
the International Electrotechnical Commission (IEC).
Risk of chemical substances
Some of the alloys used in the components of this instrument
contain small amounts of lead for improved machining.The

used as intended,the lead in the alloys is not released and
does not represent any risk to the user.

the EU Regulation 1907/2006 (REACH) at:
http://www.pfmmedical.de/downloads
Mains voltage precautions
Never remove any part of the housing.The replacement of
components and any adjustment or calibration must be
carried out by trained service technicians.
Electromagnetic interference
The electromagnetic environment should be assessed
before the pfm Forceps EWF 600 are operated. Do not use
this instrument near strong sources of electromagnetic
radiation (for example, unshielded, intentionally operated
high-frequency sources) because these can interfere with
the proper operation of the instrument.The pfm Forceps

on electromagnetic immunity and emissions.
WARNING
Caution! Switch off the instrument and
disconnect it from the power supply before
opening or removing any part of the housing.
Safety instructions

8pfm Forceps EWF 600 Rev. 2022-04-01
Part 2 – Introduction
Antenna
Forceps
1
2
2.1 View of the pfm Forceps EWF 600
1
3
4
2
2.2 Technical data for the pfm Forceps EWF 600
Dimensions (W/D/H): 180 × 290 × 250 mm
Temperature range: +30°C to +70°C
Temperature accuracy: +/- 1°C, temperature display in
1 degree steps
Reaching the max. operating temperature (70°C):
after approx. 15 min.
Charging time: approx. 30 min.
Power supply: 110 - 240 V, 50/60 Hz
Fuse: 0.8 A
Weight: 4.8 kg
Pollution degree (according to IEC 61010-1): II
Overvoltage category (according to IEC 61010-1): II
Fluctuations in mains voltage: ±10% of the mains
voltage
Base station
Display
3
4
2.3 Scope of delivery
pfm Forceps EWF 600
REF: 600600
Scope of delivery
Base station
2 Forceps each with one pair of standard tips 2 mm
(REF 600610)
1 Mains power cable
NOTE
The up-to-date electronic operating manual can be found
on our website: http://www.pfmmedical.com/downloads
Introduction

9pfm Forceps EWF 600 Rev. 2022-04-01
Operating instructions
Part 3 – Operating instructions
Before unpacking the instrument,please check that it is
complete and undamaged.
Disassemble the packaging and remove the instrument.
The accessories are packaged separately.
Please read the operating manual carefully before using

The instrument should be placed on a stable,vibrtion-free
table or desk.

surface.

immediate vicinity of the instrument.
The instrument must only be used indoors, and never in
locations where there is a risk of explosion.
Position the instrument so that the power plug is always
accessible.
Room temperature at the installation location of the
instrument between +10°C and +40°C.
Relative humidity at the installation location of the
instrument max.80% (non-condensing).
Ambient temperature during the transportation and
storage of the instrument: between -10°C and +50°C.
Relative humidity during the transportation and storage
of the instrument: max.80% (non-condensing).
3.1 Transportation, unpacking and setting up the instrument
The operator is responsible for checking that the instrument is working properly and safely.The operator shall assume
responsibility for any use of special equipment and/or materials for operating the instrument.
NOTE
If possible, retain the original packaging for the entire lifetime of the instrument so that you can repackage the
instrument correctly if it needs to be sent for servicing.

10 pfm Forceps EWF 600 Rev. 2022-04-01
3.2 Initial operation
Power socket
Instrument fuse
Power switch
1
2
3
1 2 3
Before switching on the pfm Forceps

the supply voltage and frequency


installation location.
Always connect the instrument to an
earthed wall socket.
Plug the power cable into the socket
on the back of the instrument.
The instrument socket also contains
the fuse holder.
Switch on at the mains power switch.
Now switch on at the power switch
on the instrument.
1=ON, 0=OFF
WARNING
Caution! Only use the mains
power cable with ferrite core
supplied with the instrument.
Caution! Do not use an extension
cable.
Caution! If the instrument is
not operated with the mains
power cable supplied, the user
must carry out a safety test
with the new mains power cable
before using the instrument for
the first time.
Caution! If the instrument does
not heat up, or heats up too
much, it should immediately be
taken out of operation. If this
occurs, contact a service
technician.
Operating instructions

completely recharged.
For this purpose, the temperature
setting in the display should be OFF
on delivery, this is already set at the
factory.
Put the respective forceps in the
colour-coded charging station.
Charging the forceps takes approx.
1 hour, the charging status is
indicated on the display.
As soon as the batteries are fully
recharged,the desired temperature
can be set in the display.
When the batteries are completely
discharged (0%),this is indicated by

3.3 Initial recharging of the batteries
Colour-coded charging stations
1
1
WARNING
Caution! If the forceps have not been used for a long period of
time, this initial recharging of the batteries should be carried out
again. By pressing the –button, the temperature setting can be
set to OFF .
Caution! The forceps should always be fully recharged.
Caution! If the battery capacity decreases/reduces or in the event
of malfunctions, the forceps should be taken out of operation. If
this occurs, contact a service technician.
Caution! The handpieces of the forceps must be free of paraffin
before they are put in the respective charging station to recharge.

11pfm Forceps EWF 600 Rev. 2022-04-01
3.4 Display
WARNING
Caution! Do not operate the
instrument if the display does
not work, shows illogical or
incorrect values, or is damaged.
SET TEMPERATURE
ACTUAL TEMPERATURE
Temperature setting plus +
Temperature setting minus –
1
2
3
4
2
3
4
1
3.5 Temperature setting
The display shows the SET TEMPERATURE and the
ACTUAL TEMPERATURE.
The desired temperature is set by pressing the +or –
button.
This set temperature will be maintained until the next
adjustment is made.
Depending on whether the newly set value is higher or
lower than the current temperature,a rise or a fall to the
programmed temperature can be observed on the display.
The operating temperature can be set between +30°C and
+70°C.
The tips of the forceps are gold-plated for optimal thermal
conductivity.
WARNING
Caution! The tips of the forceps can be very hot.
Caution! If the forceps tips or the forceps
handpieces become too warm, the instrument
should immediately be taken out of operation.
If this occurs, contact a service technician.
3.6 Illumination of the working area
1

1
1
White forceps illumination
1
The pfm Forceps EWF 600 have an
integrated white light in order to
illuminate the work area for better
detection of smaller tissue samples.
The white illumination can be

the corresponding temperature

Operating instructions

12 pfm Forceps EWF 600 Rev. 2022-04-01
Operating instructions
3.9 Menu settings
The pfm Forceps EWF 600 are equipped
with a modern touch screen. Lightly

conveniently switches between the
various display options.
Language
Press the Language button to select

Signal
Press the Signal button to switch the

Brightness
Press the Brightness button to adjust the
brightness of the display.There are
three levels in total.
Service menu
Press the button to enter the
service menu.Access is password-
protected.
1
Connection signal strength
1
1
Blue forceps illumination
1
The set temperature is kept costant via
a wireless connection signal between
the forceps and the base station.The
signal strength is also shown on the
display.The blue diode on the forceps
indicates a stable connection.
WARNING
Caution! Make sure that the
distance between the base
station and the forceps is
always correct. If the distance
is too great, the quality of the
signal strength will decline and
lead to an unstable connection.
A poor connection, or no
connection, is indicated by the
blue forceps light flashing.
3.8 Connection signal strength
3.7 Forceps battery level
1
Forceps battery level
1
The battery level of the forceps is
indicated on the respective display.
Charging the forceps takes approx.
30 minutes.
The memory capacity during
application is approx. 30 minutes.
A low battery level is additionally
indicated in good time by the white

forceps must then be exchanged.
1
White forceps illumination
1

13pfm Forceps EWF 600 Rev. 2022-04-01
3.10 Factory settings
By lightly swiping the screen with the


detailed information on the current

hardware.
3.11 Replacing the forceps tips
To replace the forceps tip, the black
clamping screw on the holder for
the forceps tip must be loosened and
removed.
Then the gold-plated tip of the
forceps can be carefully removed
upwards.
The selected forceps tip is mounted in
reverse order.
Caution: The parallel alignment of
the forceps tips can only be achieved
when the clamping screw is loosened.
Forceps tips
Clamping screw
1
1
2
2
3.12 Malfunctions and their correction
Fault Possible cause Remedy
No display after switching on the
instrument
Mains cable not correctly connected Check the mains cable connection
Mains cable defective Check the mains fuse and replace if necessary
Instrument fuse defective Change the instrument fuse
Forceps tips do not reach the set
temperature
Forceps are not charged Check the battery level,change the forceps
No connection signal Check the connection signal on the forceps
(blue diode)
Check the connection signal on the display
Check the battery level
Check the antenna
Forceps tips cannot be aligned Dirt
Tips position not correctly aligned
Check the clamping screw or clean
Check the adjustment of the forceps tips position
before clamping
Forceps are not charged correctly
or not charged at all
Battery defective Battery must be replaced
Charge contacts unclean Clean the contacts
Forceps not inserted correctly Check the position of the forceps
Connection signal Check
Battery completely discharged



Display does not respond Grease (e.g. from hand cream)
Dirt and dust
Humidity
Display damaged
Check the display for damage or clean it
The display must be dry and free of dirt
Restart the instrument
Operating instructions

14 pfm Forceps EWF 600 Rev. 2022-04-01
Part 4 – Maintenance, cleaning and care
In order to guarantee the reliable function of the pfm
Forceps EWF 600,routine maintenance should be undertaken
by a trained service technician once a year. pfm medical ag
provides maintenance to ensure that your instrument
always remains in perfect condition. Details can be
obtained from your sales representative or directly from
pfm medical ag.We recommend an annual electrical safety
inspection.
4.1 Maintenance
4.2 Cleaning and care
For the instrument to function
reliably, it must be kept clean by the
user. Mild household detergents are
suitable for this purpose. Do not use
any aggressive cleaning agents or
solvents. Do not allow liquids to
penetrate the inside of the charging
stations. It is particularly important to



WARNING
Caution! Before cleaning, switch
off the instrument and remove
the mains power plug.
Caution! When handling
disinfectants and cleaning
agents, always follow the
manufacturer’s instructions
regarding safety, dilution and
exposure time.
Maintenance, cleaning and care
4.3 Touch screen/display cleaning and care
The display and touch screen are made of glas and should
not be touched with hard,sharp or pointy objects.Do not
use any aggressive cleaning agent or solvents for the cleaning.
No glass cleaners or detergent should be used as they
contain aggressive soap solutions that attack and damage the
surface.We recommend cleaning the touch screen without

WARNING
Caution! The display should not be sprayed with
a cleaning agent or disinfectant because there is
a danger that liquid will get between the films or
behind the display, and damage the display.

15pfm Forceps EWF 600 Rev. 2022-04-01
4.5 Decontamination
For the regular disinfection of the work surfaces and other
surfaces of the pfm Forceps EWG 600, we recommend using
single-use disinfectant wipes, for example those recommended
by the RKI (Robert Koch Institute) or the VAH (Association
for Applied Hygiene) list: “Mikrozid AF” and “Bacillol AF”.
Repairs and maintenance work are usually carried out on
site. If this is not possible for any particular reason, the
instrument can be sent to pfm medical ag. Before you
send an instrument to pfmmedical for a service,it must
be suitably cleaned and decontaminated.This also applies
to instruments undergoing a service on site. Contaminat-
ed instruments pose a potential health hazard for anyone
coming into contact with them due to infectious agents,
pathogens or medicinal products.The legal requirements
for the handling of contaminated instruments are specified
in various regulations, including the Occupational Safety
and Health Act (ArbSchG),the Biological Agents Ordinance
(BioStoffV), the Occupational Safety Act (ASiG) and the

the instrument has been decontaminated, please complete


http://www.pfmmedical.com/downloads
4.4 Returning the pfm Forceps EWF 600 for repair or maintenance

completed in advance and enclosed with the instrument.
If it is found that the instrument poses a potential hazard,
we reserve the right to return the instrument to the sender
immediately at the sender’s expense.
WARNING
Caution! Always send the instrument in the
original packaging together with the mains
cable. Remove the forceps from the base station
and carefully package them individually. Please
contact pfmmedical if you no longer have the
original packaging.
Caution! The package must be labelled with a
UN 3480 hazard label prior to dispatch.
Maintenance, cleaning and care
4.6 Instrument fuse
Instrument fuse
1
1
The instrument fuse is located on the
rear of the instrument,and is
integrated into the power switch.
To replace the fuse,the instrument

switch and the mains power plug
must be unplugged.
Open the protective cover with a

the fuse holder.
The fuse can then be replaced with a
new one.
WARNING
Caution! Switch off the
instrument and disconnect it
from the power supply before
replacing the fuse.

16 pfm Forceps EWF 600 Rev. 2022-04-01
The instrument has been carefully checked and tested
by us. However, in the event of any defect,apart from
minor defects, occurring in an instrument or spare part
distributed by us up to one year from delivery, we undertake

prejudice to any statutory or other contractual claims,
even where the defect was not present on delivery to the
customer, provided that there has been no unauthorised
interference with the instrument by third parties.This
warranty does not cover normal wear and tear, nor does
it constitute a guarantee of quality or durability of the
instrument.
The remedying of defects under this warranty shall be
carried out, at our discretion,by the replacement or repair
of defective parts. Furthermore, spare parts can be supplied
for 5 years after delivery of the instrument. Any warranty
claims on the part of the customer beyond the above are
hereby excluded,without prejudice to any statutory or
other contractual claims.This applies in particular to any
compensation claims for damage, consequential damage or
costs relating to the defect.The transport of the instrument
to us and return transport during this period shall be at the
customer’s risk.
To assert a claim under this warranty, the instrument
concerned must be sent to us, at the customer’s expense
and risk,with a detailed description of the defect, and
specifying the purchase order number, delivery note
number and invoice number. Our address is:
Wankelstrasse 60, 50996 Cologne, Germany.
Claims under this warranty expire 6 months from assertion
of the claim, but not before the end of the warranty period.
This warranty and any claims,rights and obligations
arising therefrom are subject solely to the material law of
the Federal Republic of Germany, to the exclusion of Private
International Law and the UN Convention on Contracts for
the International Sale of Goods. Our standard terms and
conditions of supply and payment apply in addition.
All serious incidents that occur in connection with the
device must be reported to the manufacturer and the
competent authority of the Member State where the user
and/or patient are located.
4.7 Warranty
4.8 Declaration of Conformity
The current Declaration of Conformity can be found on our
website: http://www.pfmmedical.com/downloads
Maintenance, cleaning and care

17pfm Forceps EWF 600 Rev. 2022-04-01
Tripod forceps
REF 
Part 5 – Accessories
Spare tips box
REF 
Box for storing forceps tips

tips
For convenient storage of the
forceps during operation.
REF     
Size     
Type    round round
Surface smooth ribbed ribbed ribbed ribbed
PU     
2
10.5
1
11.00
4.5
9.5
Ø 1
9.5
Ø 1
9.00
Forceps tips 2 mm
REF 


Surface: smooth
PU: 1 pair
Accessories

18 pfm Forceps EWF 600 Rev. 2022-04-01
Part 6 – Disposal of the pfm Forceps EWF 600 when put out of use
Our Environmental Contribution:
The WEEE directive 2002/96/EC (WEEE = Waste Electrical and Electronic Equipment) was issued in Europe with the aim
of reducing the growing quantity of electronic scrap from discarded electrical and electronic devices and disposing of it in
an environmentally friendly manner. In Germany, the directive was anchored in the 2005 Electrical and Electronic
Equipment Act (ElektroG),which implemented both the WEEE directive and the RoHS (Restriction of Hazardous
Substances in Electrical and Electronic Equipment).
At pfm medical ag,we feel responsible for our products,from the initial concept through to their disposal, and we regard
this as an opportunity for us to make our contribution to the conservation of resources.As the manufacturer, we assume
responsibility for the disposal of the decommissioned instrument on your behalf.
To return the electrical device,please proceed as follows:
1. Contact us using one of the following options
Telephone [phone]
Email: [email protected]
Post: pfm medical ag,Abteilung Histotechnology, Wankelstr. 60, 50996 Cologne, Germany
2. Prepare the device for transportation (please only use the original packaging) and commission a freight forwarder of
your choice with the return transport of the device to the following address:
pfm medical ag
Abteilung Histotechnology
Wankelstr. 60
50996 Cologne, Germany
3. As the manufacturer,we will bear the cost of the disposal.Should nothing to the contrary be agreed to,the owner/user
of the instrument bears the transport and packaging costs
WARNING
Caution! If the device has come into contact with infectious material and cannot be disinfected
or decontaminated, we cannot accept it for disposal.
Disposal

19pfm Forceps EWF 600 Rev. 2022-04-01
For your notes
Notes

Contact
www.pfmmedical.com – For more information about pfm medical ag products IFU200600/Rev.2022-04-01
pfm medical ag
Wankelstrasse 60
50996 Cologne
Germany

DIN EN ISO 13485
Do you have any questions?
Our Customer Solutions Team will be happy to advise you.
[email protected]
[phone]
[phone]