2352 Generator Instruction Manual V8.0 Jan 2012.pdf
Page 1
Instruction manual
Bipolar Generator
2352
GA-A 121 /
/ Index: 2012--01 V8.0 / ÄM: PDG11--5360
Page 2
Important general notes and instructions for use
Make sure that this product is used only as intended and described in this instruction manual, by
adequately trained and qualified medical personnel, and that maintenance and repair are only car
ried out by authorized experts.
Use the product only in the combinations and with the accessories and spare parts specified in this
instruction manual. Use other combinations, accessories and replacement parts only if they are
expressly intended for the planned application and if the performance characteristics and safety
requirements are met. The product must not be altered in any way.
Reprocess the products in accordance with the manual before every use and before return ship
ment to protect the patient, user and third parties.
Immediately upon receipt, check the product and its accessories for completeness and possible
damage. Should the shipment give right to complaints, please inform the manufacturer or supplier
immediately.
Subject to technical changes!
Due to ongoing developments, the illustrations and technical data may deviate slightly.
GERMANY
RICHARD WOLF GmbH
75438 Knittlingen
Pforzheimerstr. 32
Telephone: +49 70 43 35-0
Telefax:
+49 70 43 35-300
MANUFACTURER
info@richard-wolf.com
www.richard-wolf.com
USA
RICHARD WOLF
Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Toll Free: 001 (800) 323 - 9653
Phone: 001 (847) 913 - 1113
Fax:
001 (847) 913 - 1488
sales@richardwolfusa.com
www.richardwolfusa.com
UK
RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW17 0HB
Telephone: + 44 20 89 44 74 47
Telefax:
+ 44 20 89 44 13 11
admin@richardwolf.uk.com
www.richardwolf.uk.com
BELGIUM / NETHERLANDS
N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
9031 Gent Drongen
Telephone: +32 92 80 81 00
Telefax:
+32 92 82 92 16
FRANCE
RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
F-51100 Reims
Telephone: +33 3 26 87 02 89
Telefax:
+33 3 26 87 60 33
AUSTRIA
RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
A-1160 Vienna
Telephone: +43 14 05 51 51
Telefax:
+43 14 05 51 51 45
france@richard-wolf.com
austria@richard-wolf.com
www.richard-wolf.com
endoscopy@richard-wolf.be
www.richard-wolf.be
Marketing Office
U.A.E
RICHARD WOLF Middle East
P.O. Box 500283
AL Thuraya Tower 1
9th Floor,
Room 904, Dubai
Telephone: + 9 71 43 68 19 20
Telefax:
+ 9 71 43 68 61 12
middle.east@richard-wolf.com
www.richard-wolf.com
GA-A 121
INDIA
RICHARD WOLF India Private Ltd.
JMD Pacific Square
No. 211 A, Second Floor
Behind 32nd Milestone
Gurgaon - 122 001
National Capitol Region
Telephone: + 91 12 44 31 57 00
Telefax:
+ 91 12 44 31 57 05
india@richard-wolf.com
www.richard-wolf.com
0
Page 3
Contents:
1
1.1
1.2
Important Instructions
Levels of danger
Safety instructions
1
1
1
2
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.7.1
2.7.2
2.8
General information
Symbol
Intended use
Indications and field of use
Contraindications
Side effects
Risk
Combinations
Potential equalization
Requirements for the products and components of a combination
Electromagnetic compatibility (EMC)
2
2
3
3
2
3
3
3
3
4a
4b-4c
3
3.1
3.2
3.3
3.4
3.4.1
3.4.2
Fundamental physics of high-frequency surgery
Endogenous effects of electrical current in living biological tissue
Using the thermal effects in surgery
Bipolar surgical techniques
Complications during Coagulation
Adhesion effect
No coagulation effect
5
5
5
9
10
10
10
4
4.1
4.1.1
4.1.2
11
11
11
4.1.3
4.1.4
4.1.5
4.1.6
4.2
4.3
4.4
Risks and safety during high frequency surgery
Accidental burns
Accidental activation of the HF Generator
Unintentional thermal tissue damage as a result of unsuitable and/or faulty
accessories
Unintentional thermal tissue damage due to carelessness
Unintentional thermal tissue damage due to incorrect dosage
Accidental burns caused by hot electrodes
Unintentional thermal tissue damage due to device failure
Danger of explosion
Interference with other electronic device
Notes and instructions on the use of HF surgical devices
12
12
12
12
13
13
13
13a
5
5.1
5.1.1
5.2
5.2.1
Illustration
Front view
Legend
Rear view
Legend
14
14
14
15
15
6
6.1
6.2
Set-up
Connection diagram
Preparation
16
16
17
7
7.1
7.2
7.2.1
7.2.2
7.2.3
7.2.4
7.3
7.4
Checks
Visual check
Function check
Automatic function checks when turning on the power switch
Checking the optical signals - „Test routine 4“
Checking the acoustic signals „Test routine 5“
Function check of bipolar forceps
Automatic error documentation - („Test routine 2“)
ERROR-list
19
19
19
19
19
20
21
21
22
GA-A 121/ 2012-01 V8.0
Page 4
8
8.1
8.2
8.3
8.3.1
8.3.2
8.3.3
8.4
Application
General
Description of controls
Call-up of test routines
Test routine 1 - basic setting
Test routine 3 - limitation of activation time
Test routine 6 - setting the sound volume in 16 steps
Application
24
24
24
27
27
28
29
29
9
9.1
30
9.1.1
9.1.2
9.2
9.3
9.3.1
9.3.2
9.3.3
9.4
Cleaning, Disinfection, Sterilization and Maintenance
Cleaning, disinfection and sterilization of Bipolar Generator and
foot switch
Bipolar Generator
Foot switch
Cleaning, disinfection and sterilization of accessories
Maintenance
Maintenance intervals
Modifications and repairs
Care of the device and the foot switch
Safety checks
10
10.1
10.2
10.2.1
10.2.2
10.2.3
10.2.4
10.2.5
10.2.6
10.2.7
10.2.8
10.2.9
10.3
10.4
10.5
10.6
10.7
10.7.1
10.7.2
10.7.3
18.8
Technical description
Trouble shooting
Installation
Spatial requirements
Possibilities for installation in an operating theatre
Mains/Line connection
Protection against explosions
Protection against moisture
Cooling
HF interference
Receiving inspection
Protection of the environment
Technical data
Operating, storage, transport and shipping conditions
Diagrams
Spare parts
Replacing parts
Fuses in the unit
Taking out of service
Disposal of the product, packaging material and accessories
Accessories list
39
39
40
40
40
11
Literature
41
GA-A 121/ 2012-01 V8.0
30
30
30
30
31
31
31
31
32
33
33
34
34
34
34
34
35
35
35
35
35
36
37
37
Page 5
11
Page 6
2
General information
2.1
Symbol
Symbol
Designation
Attention, Attention!
Follow the instruction manual!
OFF (no connection to the power supply / mains)
ON (connection to power supply / mains)
Potential equalization
Type CF applied part
Footswitch
Bipolar coagulation
Recycle the product separately. Do not discard together with other waste.
Non-ionizing electromagnetic radiation
(increased, possibly hazardous electromagnetic radiation)
A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard
of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (us)
A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as
Medical Electrical Equipment to standard CAN/CSA C 22.2 No. 601.1 (c) and UL 60601-1 (us)
Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or
packaging is marked with this symbol. Products of category IIa and above as well as sterile products or products with measuring function of category I, are additionally marked with the code number
of the notified body (0124).
2.2
Intended use
In combination with bipolar instruments, the bipolar generator is used for bipolar
tubal coagulation and coagulation of adhesions under endoscopic view.
This product is exclusively intended for use by specialized medical personnel and
must only be used by medically qualified and adequately trained persons.
2.3
Indications and field of use
2.4
Contraindications
In conjunction with endoscopic accessories, this product is used for therapy, spe
cifically for tubal sterilisation and hemostasis, in the different medical disciplines
such as gynecology, urology, surgery, ENT.
2352
The use is contraindicated in the case of inflammations or bacterial contamination
of wounds in the operating field.
Contraindications directly related to the product are presently unknown. On the
basis of the patient's general condition the doctor in charge must decide whether
the planned use is possible or not.
For further notes and instructions please refer to the latest medical literature.
21
Page 7
2.5
Side effects
Z Hemorrhages (mesosalpinx, puncture site, retroperitoneal hematoma,
late intraabdominal Arteria iliaca externa and interna, other vessels)
Z Injuries / lesions of the intestine
Z Technical failure when creating a pneumoperitoneum
Z Burns
Z Tubo--ovarian abscess
Z Postoperative pain
2.6
Risk
2.7
Combinations
Sterilization failure following bipolar tubal coagulation
Causes:
Z Technical fault
' Unsuitable HF generators or generator settings.
' Bipolar instrument and HF generator are not compatible.
Z Methodological errors lead to unwanted pregnancies despite a presumably
correct procedure.
' Tubo-uterine fistulization.
' Incomplete tubal coagulation.
' Recanalization of the tubes due to incomplete coagulation and repair mech
anisms.
.
IMPORTANT!
In addiation to this manual, be sure to follow the manuals of the products
used in combination with this product.
Possible electromagnetic or other interference that may occur between the
product and other products can cause faults or malfunctions.
The bipolar generator must only be used with the instruments and bipolar connec
tion cables listed or referred to in the accessories list in section 10.8.
For products marked UL, under standard conditions, this system must not exceed
a leakage current of 300 A when jointly connected via a (1) power cord.
All devices connected to this system must be UL listed or classified. In addition,
the entire leakage current of the system should be monitored and must not exceed 300 A.
2.7.1
Potential equalization
3
The potential equalization cable establishes a direct connection between a medical electrical device and an equipotential bonding rail.
It serves to equalize differences in potential between enclosures of electrical
equipment and firmly installed conductive parts in the patient environment.
2352
Page 8
2.7.2
Requirements for the products and components of a combination
1.5m
1.5m
The general requirements depend on whether the pro
ducts / components are inside or outside the patient envi
ronment.
1.5m
IEC 60601-1, 3. Ed.
Medically used room
inside the
patient environment
MP
MP
~
~
MP
MP
outside the
patient environment
-
-
Leakage currents to section 16.6
IEC 60601-1:2005 / EN 60601-1:2006 *
Verification of the total patient leakage current
**
~
MP
NMP
~
~
**
NMP
MP
-
Verification of leakage currents
**
~
MP
Requirements / measures
Non-medically
used room
a) additional protective earth connection
(consult the corresponding manufacturer),
-
or
NMP
b) additional isolating transformer for medical applications **
~
MP
NMP
~
MP / NMP
MP
~
**
MP
NMP
~
~
MP
MP / NMP
~
~
additional "isolating transformer" to
IEC/ EN60601-1 **
Functional connection
MP
NMP
*
**
4a
Verification of leakage currents
a) no plugs with metal housing, or
b) additional isolation device (to avoid voltage differentials)
-
~
Verification of leakage currents
a) common protective earth connection, or
b) additional protective earth connection at MP (clarify with the corre
ponding manufacturer), or
c) additional isolation device (to avoid voltage differentials), or
d) no plugs with metal housing in the patient environment
additional isolating device to IEC/
EN 60601-1
Multiple socket strip
Power supply grid
= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 08
= non-medical electrical device in accordance with product-specific IEC/EN/UL standards
When connected via a power bar under standard conditions the earth leakage current of the power bar must not exceed 5 mA.
e.g. Richard Wolf video cart with "isolating transformer"
2352
Page 9
.
2.8
IMPORTANT!
The persons combining products to form a system are responsible for not impairing the system's compliance with
performance and safety requirements, and that the technical data and the intended use are adequately fulfilled.
Possible electromagnetic or other interference that may occur between the product and other products can cause
faults or malfunctions.
When selecting the system components, make sure that they meet the necessary requirements of the medical envi
ronment they are used in, in particular IEC/ EN 60601-1 (3. Edition IEC/EN 60601-1, section 16). In case of doubt
contact the manufacturer(s) of the system components.
Do not touch connectors for electrical connections between various components (such as signal input connectors
and signal output connectors for video signals, data exchange, controls etc.) and the patient at the same time.
Electromagnetic compatibility (EMC)
Please observe the following:
The device/system in the following referred to as product always relates to Bipolar Generator 2352.
The product does not have any performance features classified as essential performance features in accordance with IEC/EN 60601-1.
Guidelines and manufacturer's declaration - Electromagnetic emissions
The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Emissions measurement / test
Compliance
Electromagnetic environment - Guidelines
HF emissions to CISPR 11
Group 1
The product uses HF energy for its internal function.
The HF emission level is extremely low and it is not likely to cause any
interference in nearby electronic equipment.
HF emissions to CISPR 11
Class B
Harmonic emissions
to IEC 61000-3-2
Class A
In conformity with IEC 61000-3-3 “Emission of voltage fluctuations
/ flicker"
The product is suitable for use in all establishments, including domestic
establishments. This also includes establishments directly connected to
the public low voltage power supply network that supplies buildings used
for domestic purposes.
Guidelines and manufacturer's declaration - Electromagnetic immunity
The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Compliance
Immunity tests
IEC 60601 test level
Electromagnetic environment - Guidelines
Electrostatic discharge (ESD)
to IEC 61000-4-2
6 KV contact discharge
8 KV air discharge
Yes
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the re
lative humidity should be at least 30%.
Electrical fast transience, bursts
to IEC 61000-4-4
2 KV for power supply lines
1 KV for input and output
lines
Yes
Mains/line power quality should be that of a typical
commercial or hospital environment.
Surge voltage (surges)
to IEC 61000-4-5
1 KV line to line
voltage
2 KV line to ground
voltage
Yes
Mains/line power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short interruptions and sup
ply voltage variations
to IEC 61000-4-11
Voltage dip for 0.5 cycle
> 95% UT *
Voltage dip for 5 cycles
60% UT *
Voltage dip for 25 cycles
30% UT *
Voltage dip for 5 sec
> 95% UT *
Yes
Mains/line power quality should be that of a typical
commercial or hospital environment. If the user of
the product requires continued operation during
power mains/line interruptions it is recommended
that the product be powered from an uninterrupti
ble power supply or battery.
Power frequency (50/60 Hz) magnetic
field,
to IEC 61000-4-8
3 A/m
Yes
Power frequency magnetic fields should be at le
vels characteristic of a typical location in a com
mercial or hospital environment.
* NOTE: UT is the line / mains voltage prior to application of the test level.
2352
4b
Page 10
Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting
The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Immunity tests
IEC 60601 test level
Compliance
Electromagnetic environment - Guidelines
Portable and mobile RF communications equipment should
be used no closer to any part of the product, including ca
bles, than the recommended separation distance calculated
from equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1.2 p P
Conducted HF interference
to IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Radiated HF interference
to IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
d = 1.2 p P for 80 MHz to 800 MHz
Yes
d = 2.3 p P for 800 MHz to 2.5 GHz
P = Nominal power output rating of the transmitter in watts
(W)
(according to the transmitter manufacturer)
d = recommended separation distance in meters (m)
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey1, should be less than the
compliance level in each frequency range2.
Interference may occur in the vicinity of devices with the
following symbol:
REMARKS:
At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec
tromagnetic waves is affected by absorption and reflexion from buildings, objects and people.
1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio
and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic
site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance
level above, the product should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product.
2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.
Recommended separation distances between portable and mobile HF telecommunication devices and devices which
are not life-supporting
The product is intended for use in an electromagnetic environment where HF disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica
tions equipment and the product.
Rated nominal output power of the
transmitter (Watts)
Separation distance as a function of transmitter frequency (m)
150 kHz to 80 MHz
d = 1.2 p P
80 MHz to 800 MHz
d = 1.2 p P
800 MHz to 2.5 GHz
d = 2.3 p P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be
determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W).
REMARKS:
At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec
tromagnetic waves is affected by absorption and reflexion from buildings, objects and people.
WARNING
Power supply does not have a protective earth connector!
Danger of electric shock!
Connect the device only to a power supply with protective earth.
4c
2352
Page 18
4.1.2
Unintentional thermal tissue damage as a result of unsuitable and/or faulty accessories
CAUTION!
Make sure that only accessories in perfect working order are used for high-fre
quency surgery.
Use only accessories approved by the device manufacturer.
Use only active accessories designed for a maximum rated voltage that is greater
or equal to the maximum HF output voltage (190 V) specified in section 10.3,
Technical data.
All insulations of electrodes, electrode holders, cables, plugs etc. must be flaw
less.
Do not use defective accessory items.
4.1.3
Unintentional thermal tissue damage due to carelessness
4.1.4
Unintentional thermal tissue damage due to incorrect dosage
2352
12
Page 19
4.1.6
Unintentional thermal tissue damage due to device failure
WARNING!
A failure of the HF surgical device can cause an undesirable increase in
the HF power output!
Danger! The patient can suffer unintended tissue damage!
Contact the service department!
4.2
Danger of explosion
4.3
Interference with other electronic devices
13
2352
Page 20
4.4
Notes and instructions on the use of HF surgical devices
Z Avoid touching the patient and, at the same time, metal parts which are grounded/earthed or have considerable capacity relative to ground/earth.
We recommend using antistatic cloths.
Z Avoid skin to skin contact, separate with dry gauze.
Z Apply any monitoring electrodes of physiological monitoring devices as far
away as possible from HF surgical electrodes.
Z Cables of HF surgical electrodes should neither touch the patient nor other
cables or lines.
Z Cardiac pacemakers or other active implants in patients may fail or be damaged. In case of doubt seek expert advice.
WARNING!
If the HF surgical devices fail, an undesirable increase in the output
power may occur.
13a
2352
Page 43
10.3
Technical data
Type/model
2352.001
2352.002
2352.011
Voltage
Frequency
V
Hz
220 - 240
100 - 127
100 - 127
50 / 60
50 / 60
50 / 60
Standby max.
5
130
5
130
5
130
Electromagnetic compatibilitiy (EMC)
Medical Devices Directive 93/42/EEC
Group in accordance with MedGV
Classification
Protection class under IEC/EN 60 601-1 ,
UL 60601-1, CSA C22.2 no. 601.1-for USA
Degree of protection when used in the presence of
flammable mixtures
Dregree of protection against the ingress of fluids
Foot switch
Power
consumption
VA
Power rating
A
Standby
0.03
0.05
0.05
max.
0.6
1.3
1.3
Fuse
T 0.63 L
T 1.6 H
T1.6A, 250 V
IEC / EN 60 601-1-2
Class IIb
I
CF
I
IE
The device is not protected against explosions.
(Do not operate this device in areas where
flammable substances are present.)
IP 20 (not protected)
IP X8
Duty factor
Weight
Dimensions WxHxD
Short-time duty int. 10s / 30s
5 kg
320.5 mm x 120.5 mm x 255 mm
Safety features:
Output error (dosage) monitoring
Automatic limitation of max. HF power
Automatic limitation of max. activation power
Automatic function check
Automatic error recognition
Automatic error message
yes
adjustable in steps of 1 Watt
yes, adjustable via test routine 3
selfcheck after switching on
yes
yes
Automatic documentation
Automatic storage of operater's errors
Automatic storage of function errors
Automatic storage of safety errors
Bipolar coagulation
Form of HF voltage
Nominal frequency of HF voltage
Peak value of HF voltage
HF nominal output
HF power limitation (P HF max )
Adjustment of HF power limitation
Indication of HF power limitation
Accuracy of HF power limitation
Activation of coagulation
HF output socket
2352
yes
yes
yes
unmodulated sine-shaped AC voltage
350 kHz
max. 190 V no-load AC
50 watt at 75 Ohm
from 1 watt to 50 watt in steps of 1 watt
via up/down buttons
7-segment display, 2 digits
+/- 20 %
via foot switch
1, Martin type
36
Page 46
10.6 Spare Parts
Units
Type/model
Designation
1
2440.03
Power cable (Europe) 3 m
1
1
N710006
64 268.004
Power cable (USA) 8.0 ft.
Fuse, T1.6 H (pack of 10)
1
1
1
72 315.010
64 268.029
2030.103
Fuse T 1,6 L 250 V - USA
Fuse, T 0.63 L (pack of 10)
Foot switch, AP Version
10.7
Replacing parts
10.7.1 Fuses in the unit
CAUTION!
The values imprinted on the fuses must correspond to the values
indicated on the identification plate. Only use fuses listed in the spare
parts list.
♦ Switch off the device and disconnect the power cable from the power
supply and from power input socket.
♦ Push together clamps (2) of fuse holder (1) with your thumb and index
finger and pull out fuse holder.
♦ Pull out and replace fuses (3).
♦ Reinsert fuse holder and push it in until it snaps into place.
2352
39
Page 47
10.7.2
Taking out of service
10.7.3
Disposal of the product, packaging material and accessories
For the disposal follow the laws and regulations valid in your country.
' For further information please contact the manufacturer.
10.8
Accessories list
To take the device out of service, switch off the power switch and disconnect the
device from the power supply / mains.
Quantity
Type
Designation
1
8108.031
Bipolar connection cable, length 3 m
1
8108.051
Bipolar connection cable, length 5 m
1
8383.23
Bipolar grasping forceps
1
8384.23
Bipolar grasping forceps
1
8383.29
Bipolar coagulation suction tube
1
8384.29
Bipolar coagulation suction tube
1
8383.091
Bipolar coagulation forceps
1
8383.241
Bipolar grasping forceps
1
8383.242
Bipolar grasping forceps
1
8289.24
Bipolar coagulation suction tube
1
8384.24
Bipolar grasping forceps - only USA
1
8384.21
Bipolar grasping forceps - only USA
1
8383.24
Bipolar grasping forceps - only USA
1
8383.21
Bipolar grasping forceps - only USA
Quantity
Type
1
8108.131
Bipolar connection cable with forceps connector, length 3 m
1
8108.151
Bipolar connection cable with forceps connector, length 5 m
1
8211.75
Bipolar forceps
1
8211.80
Bipolar needle
1
8765.601
Bipolar needle
1
8765.611
Bipolar needle
Designation
With regard to possible combinations with Richard Wolf bipolar forceps, please refer to supplementary sheet
BB-E 194 where you will find the latest products as well as information on the intended use of the forceps.
Specifically for tubal sterilization, it is possible to combine the bipolar ERAGON tubal sterilization forceps after
Hasskamp 839300362 (fot this see manual BB-B 241) and the bipolar POWERGRIP tubal sterilization forceps
after Hasskamp 83930.xxx (for this see manual GA-E 209).
Further accessories on request.
2352
40
Page 48
11
Literature
.
IMPORTANT!
We do not gurantee that this literature index is complete.
Users are therefore obliged to always ensure that they keep themselves informed
about the latest findings in this field.
Z IEC 606011; DIN EN 606011; VDE 07501
Medical electrical devices Part 1: General requirements for safety and essential
performance characteristics
Z IEC 6060122; DIN EN 6060122; VDE 075022
Medical electrical devices Part 22: Special requirements for safety and essential
performance characteristics of high-frequency surgical devices and HF surgical
accessories
Z ISO 11197; DIN EN ISO 11197; VDE 0750211
Medical care units
Z IEC 62353; DIN EN 62353; VDE 07511
Medical electrical devices Repeat tests and tests following the repair of medical
electrical devices
Z DIN 577531; VDE 07531
Application rules for high-frequency surgical devices
Z IEC/TR3 60513; DIN VDE 0752 supplementary sheet 1; VDE 0752 supplementary
sheet 1
Basic aspects of safety standards for medical electrical devices