2352 Generator Instruction Manual V8.0 Jan 2012

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 [email protected] 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 [email protected] 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 [email protected] 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

[email protected]

[email protected] www.richard-wolf.com

[email protected] 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 [email protected] 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 [email protected] www.richard-wolf.com

0

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

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

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

30

9.1.1 9.1.2 9.2 9.3 9.3.1 9.3.2 9.3.3 9.4

30 30 30 30 31 31 31 31 32

10 Technical description 10.1 Trouble shooting 10.2 Installation 10.2.1 Spatial requirements 10.2.2 Possibilities for installation in an operating theatre 10.2.3 Mains/Line connection 10.2.4 Protection against explosions 10.2.5 Protection against moisture 10.2.6 Cooling 10.2.7 HF interference 10.2.8 Receiving inspection 10.2.9 Protection of the environment 10.3 Technical data 10.4 Operating, storage, transport and shipping conditions 10.5 Diagrams 10.6 Spare parts 10.7 Replacing parts 10.7.1 Fuses in the unit 10.7.2 Taking out of service 10.7.3 Disposal of the product, packaging material and accessories 18.8 Accessories list

39 39 40 40 40

11

41

Literature

GA-A 121/ 2012-01 V8.0

33 33 34 34 34 34 34 35 35 35 35 35 36 37 37

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

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

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

Requirements / measures

Non-medically used room

-

-

Leakage currents to section 16.6 IEC 60601-1:2005 / EN 60601-1:2006 *

Verification of the total patient leakage current

**

~ MP

NMP

~

~

MP

NMP

**

-

Verification of leakage currents

**

~ MP

outside the patient environment

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

.

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

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

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

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

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

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

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

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

Designation

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

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

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