TEM Combination System LAPARO-CO2-PNEU Instructions for Use V14.0 Aug 2020

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Copyright © RICHARD WOLF GmbH

Subject to technical changes! Due to ongoing development, the product descriptions, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local representative.

Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

www.richard-wolf.com

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Contents 1

Important information ...

8

1.1

General safety instructions and guidance for use ...

8

1.2

Safety instructions and levels of danger...

8

1.3

Structure and handling of this instruction manual ...

9

1.4

Overview diagram for TEM application ... 10

2

Technical description... 11

3

Intended use... 11

3.1

LAPARO-CO2-PNEU (performance characteristics) ... 11

3.2

TEM PUMP (performance characteristics) ... 11

3.3

TEM irrigation cannula ... 11

3.4

TEM tube set ... 12

3.5

TEM stereo telescope and documentation telescope / documentation telescope, eyepiece in 12 o'clock position / PANOVIEW telescope 30° and 50° ... 12

3.6

TEM instrument set ... 13

3.7

TEM accessories ... 14

3.8

Important surgical information ... 15

4

Side effects... 15

4.1

TEM accessories ... 15

5

Indication and scope ... 16

6

Contraindications... 16

7

Combinations ... 17

7.1

Equipotentality ... 18

7.2

Requirements for the products / components of a combination ... 19

7.3

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2007 ... 21

7.4

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014 ... 24

8

Symbols / labeling ... 27

8.1

LAPARO-CO2-PNEU / TEM PUMP / packaging... 27

8.2

LAPARO-CO2-PNEU ... 28

8.3

TEM PUMP... 28

8.4

Packaging... 29

9

Control elements and indicators ... 31

9.1

LAPARO-CO2-PNEU ... 31

9.2

TEM PUMP... 34

10

Device connectors ... 35

10.1

LAPARO-CO2-PNEU ... 36

10.2

TEM PUMP... 36

11

Illustrations ... 37

11.1

TEM irrigation cannula / TEM stereo telescope and documentation telescope / PANOVIEW telescope / TEM instrument set ... 37

11.2

TEM accessories ... 40

12

Commissioning ... 42

12.1

Installation of the TEM combination system ... 45

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12.1.1 12.1.2 12.1.3

Mounting the irrigation bottle holder ... 45 Making electrical (protective ground) and CO2 gas connections ... 45 CO2 connection... 46

12.2

Preparing the TEM irrigation cannula and NaCl plastic bottle with rubber membrane ... 47

12.3 12.3.1 12.3.2 12.3.3 12.3.4

Connecting the tube set for TEM application ... 47 TEM tube set selection ... 47 Before connecting the TEM tubes ... 48 Preparing the TEM PUMP ... 48 Connection diagrams for TEM application ... 50

13

Use ... 53

13.1 13.1.1 13.1.2

TEM application... 53 Operating principle ... 53 Surgical technique ... 54

13.2 13.2.1 13.2.2 13.2.3 13.2.4 13.2.5 13.2.6 13.2.7 13.2.8 13.2.9

Preparing the TEM instrument set... 55 Fastening the U-shaped support arm to the operating table ... 55 Inserting the rectoscope tube with obturator into the rectum ... 56 Inserting the adapter with observation window into the basic part and connecting the double bulb ... 57 Securing the basic part in the U-shaped support arm ... 57 Setting the operating field and securing the TEM instrument set ... 57 Removing the adapter with observation window from the basic part ... 57 Preparing the working insert and silicone sealing insert ... 58 Connecting the silicone sealing insert to the working insert ... 58 Connecting the assembled working insert to the basic part ... 59

13.3 13.3.1 13.3.2 13.3.3

TEM stereo telescope and documentation telescope / documentation telescope / PANOVIEW telescope ... 59 Inserting the adjustable eyepiece part... 59 Inserting the TEM stereo telescope and documentation telescope... 60 Repair instructions / return of the TEM stereo telescope and documentation telescope ... 61

13.4 13.4.1 13.4.2

Use without silicone sealing insert / without camera ... 62 Working without the silicone sealing insert... 62 Working without a camera ... 62

13.5 13.5.1 13.5.2 13.5.3

Video-assisted TEM application ... 63 Camera overview with the corresponding lenses ... 64 Insert with irrigation and insufflation insert and documentation telescope ... 64 Insert with irrigation and insufflation outer tube set and PANOVIEW telescope 30° or 50° ... 65

13.6 13.6.1 13.6.2 13.6.3 13.6.4 13.6.5

TEM accessories ... 66 Preparation of the titanium clip ... 66 Preparing the TEM clip applicator ... 67 Preparing the needle holder ... 67 Preparing the HF knife ... 68 Preparing the retractable needle ... 68

13.7 13.7.1 13.7.2 13.7.3 13.7.4 13.7.5

General notes and instructions for use... 69 Light... 69 Irrigation fluid ... 69 Electrical current... 70 Image quality ... 70 HF applications... 70

13.8 13.8.1 13.8.2

TEM combination system ... 71 Operating principle ... 71 Selecting the TEM operating mode ... 72

13.9 13.9.1 13.9.2

General notes and instructions for use... 73 Unfolding the rectal cavity ... 73 Control of the irrigation / suction pump via footswitch ... 74

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13.9.3 13.9.4 13.9.5

Possible alarms during the application ... 74 Power failure ... 75 Measures after insufflation has been performed ... 75

13.10 13.10.1

Alarm functions... 75 Setting the alarm tone volume... 76

14

Taking out of service ... 76

15

Checks... 76

15.1 15.1.1 15.1.2 15.1.3 15.1.4

Visual checks ... 77 LAPARO-CO2-PNEU / TEM PUMP ... 77 TEM irrigation cannula ... 77 TEM tube set ... 77 TEM stereo telescope and documentation telescope / documentation telescope, eyepiece in 12 o'clock position / PANOVIEW telescope ... 78 TEM instrument set ... 78 TEM accessories ... 78

15.1.5 15.1.6 15.2 15.2.1 15.2.2 15.2.3 15.2.4 15.2.5 15.2.6

Function checks ... 79 Automatic function checks of the TEM combination system ... 79 Checking the CO2 gas supply ... 80 Manual check of the TEM combination system ... 80 TEM stereo telescope and documentation telescope / documentation telescope, eyepiece in 12 o'clock position / PANOVIEW telescope ... 82 TEM instrument set ... 82 TEM accessories ... 82

16

Reprocessing and maintenance ... 84

16.1

Reprocessing procedure ... 84

16.2 16.2.1

TEM combination system ... 84 Maintenance ... 86

16.3 16.3.1 16.3.2 16.3.3 16.3.4 16.3.5

TEM irrigation cannula ... 89 Preparation / cleaning at the point of use ... 89 Disassembly before cleaning ... 89 Manual reprocessing Figures showing the reprocessing instructions ... 89 Checks... 90 Assembly before sterilization... 90

16.4

TEM reprocessable tube set ... 93

16.5 16.5.1 16.5.2 16.5.3 16.5.4 16.5.5 16.5.6

TEM stereo telescope and documentation telescope ... 94 Disassembly before cleaning ... 94 Manual reprocessing Figures showing the reprocessing instructions ... 94 Machine reprocessing Figures showing the reprocessing instructions ... 94 Checks... 95 Assembly before sterilization... 95 Sterilization ... 95

16.6 16.6.1 16.6.2 16.6.3 16.6.4 16.6.5

TEM instrument set ... 98 Disassembly before cleaning ... 98 Manual reprocessing Figures showing the reprocessing instructions ... 98 Machine reprocessing Figures showing the reprocessing instructions ... 99 Checks... 99 Assembly before sterilization... 99

16.7 16.7.1

TEM accessories (double bulb / disposable filter insert / tube) ...101 Checks...101

16.8 16.8.1 16.8.2

TEM accessories (TEM clip applicator) ...101 Disassembly before cleaning ...101 Manual reprocessing Figures showing the reprocessing instructions ...102

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16.8.3 16.8.4 16.8.5

Care Figures showing the reprocessing instructions...102 Checks...102 Assembly before sterilization...102

16.9 16.9.1 16.9.2 16.9.3 16.9.4

TEM accessories (needle holder)...105 Disassembly before cleaning ...105 Manual reprocessing Figures showing the reprocessing instructions ...105 Care Figures showing the reprocessing instructions...105 Checks...105

16.10 16.10.1

TEM accessories (HF knife, unipolar) ...108 Checks...108

16.11 16.11.1 16.11.2 16.11.3 16.11.4 16.11.5

TEM accessories (retractable needle)...109 Disassembly before cleaning ...109 Manual reprocessing Figures showing the reprocessing instructions ...109 Care Figures showing the reprocessing instructions...110 Checks...110 Assembly before sterilization...110

17

Error message / corrective action...113

17.1

Device errors ...113

17.2

Error messages for LAPARO-CO2-PNEU...113

17.3

Error messages for TEM PUMP ...114

18

Technical data and order data...115

18.1 18.1.1 18.1.2 18.1.3 18.1.4

LAPARO-CO2-PNEU ...115 Application parameters...115 Safety features ...115 Additional options ...116 Interfaces...116

18.2 18.2.1 18.2.2 18.2.3

TEM PUMP...116 Application parameters...116 Safety features ...116 Interfaces...117

18.3

TEM combination system spare parts and accessories ...117

18.4 18.4.1

TEM irrigation cannula ...118 Spare parts ...118

18.5

TEM tube set ...119

18.6

TEM stereo telescope and documentation telescope / documentation telescope / PANOVIEW telescope ...119

18.7 18.7.1

TEM instrument set ...120 Spare parts ...121

18.8

TEM accessories ...122

18.9

Other spare parts and accessories ...125

18.10

Replacing the device fuses ...126

18.11 18.11.1

Operating, storage, transport, and shipping conditions ...127 Disposal of the product, packaging material, and accessories ...127

19

Laparoscopic surgery ...129

19.1

Overview diagram for laparoscopic surgery ...129

19.2 19.2.1 19.2.2 19.2.3 19.2.4

Intended purpose ...130 Technical description...130 Intended use...130 Indication and scope ...130 Contraindications...130

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19.2.5

Combinations ...132

19.3 19.3.1

Commissioning ...133 Connecting the insufflation tube ...133

19.4 19.4.1 19.4.2

Use ...135 LAPARO-CO2-PNEU ...135 General notes and instructions for use...137

19.5 19.5.1

Checks...139 Function check ...139

19.6 19.6.1 19.6.2

Technical data and order data...141 Laparoscopic surgery accessories ...141 Insufflation tubes ...141

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1

Important information

1.1

General safety instructions and guidance for use The product and its accessories must only be used as intended following the instruction manual by adequately trained and qualified medical personnel. Maintenance and repair must be carried 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 still fulfilled. The product must not be altered in any way. Reprocess the products and accessories in accordance with the instruction manual before and after every use and before return shipment to protect the patient, user, and third parties. The instruction manual is an integral part of the product and must be stored in such a way that it is accessible at all times during the entire life cycle. It must be passed on to any subsequent owner or user. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.

1.2

Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

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1.3

Structure and handling of this instruction manual ATTENTION The system described in this instruction manual can be used for both "transanal endoscopic microsurgery (TEM)" and for "laparoscopic surgery". Devices and instruments used: n

n

Transanal endoscopic microsurgery (TEM) – LAPARO-CO2-PNEU with TEM-PUMP in combination with – TEM irrigation cannula – TEM tube set – TEM stereo telescope and documentation telescope / documentation telescope / PANOVIEW telescope – TEM instrument set – TEM accessories Laparoscopic surgery – LAPARO-CO2-PNEU without TEM PUMP in combination with – VERES cannula – RIWO-ART trocar sleeve – High flow trocar sleeve – Insufflation tube set – Laparoscopic accessories

ATTENTION "Laparoscopic surgery" is described in 19 section 19 and must be observed. Indicators and control elements, device functions, illustrations, and operating and handling steps to be performed on the LAPARO-CO2-PNEU are shown and described in TEM in sections 1–18. In some cases, these are also used in "laparoscopic surgery". An overview diagram at the start of 19 section 9 indicates the corresponding chapter in TEM

ATTENTION The TEM or laparoscopy operating mode can only be selected and switched when the LAPARO-CO2-PNEU is ready for operation (Standby mode) in the basic setting. ¶Transanal endoscopic microsurgery (TEM): see section 4 – section 13.8.2 4.8.2 ¶Laparoscopy: see 19 section 9 – section 19.4.1.2 4.1.2

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1.4

Overview diagram for TEM application The overview diagram serves as an aid in preparing for TEM application and at the same time indicates where information can be found in this instruction manual.

Prepare TEM products

8170.841 Using TEM reprocessable tube set?

No no

Using ERBE multifunctional instrument TEM?

no

Section 3

Yes

Yes Sterilely prepare hygiene filter

4170.801 Using TEM disposable tube set?

4170.804 Use TEM disposable tube set

Yes

Commission TEM combination system

Yes

Use CO2 connection for gas bottle up to max. 2 l volume

Section 3

Section 5

Section 4

Yes Mount the CO2 gas bottle holder Yes

Connect the CO2 connection to the centralized gas supply

Prepare the TEM irrigation cannula and insert it into the NaCl irrigation bottle Yes Automatic function check / Perform CO2 gas supply check Yes

Alarm functions

Section 4

Troubleshooting / corrective action

Section 7

Is LAPARO-CO2-PNEU ready for operation in basic setting? Signal is sounded

Connect hygiene filter and TEM tube set 8170.841 on device side

no

Yes

Connect TEM tube set 4170.801 or 4170.804 on device side

Error could be fixed

no

Contact R. WOLF service department

Yes Switch off LAPARO-CO2-PNEU and switch on again after approx. 30 s

Section 3

Yes

Perform manual checks

Section 5

Yes Connect TEM tube set on instrument side

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Section 3

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Technical description The mobile system is a tabletop device for transanal endoscopic microsurgery (TEM) consisting of: 1. 2. 3. 4. 5.

LAPARO-CO2-PNEU TEM PUMP TEM irrigation cannula TEM tube set TEM stereo telescope and documentation telescope / documentation telescope, eyepiece in 12 o'clock position / PANOVIEW telescope 6. TEM instrument set 7. TEM accessories

3

Intended use The system is used for pressure-controlled distension of the rectum (rectal cavity and lower part of the sigmoid) with CO2 gas for the purpose of transanal endoscopic microsurgery. The goal is to excise polyps and/or remove tumors, in conjunction with a TEM stereo telescope and documentation telescope, TEM instrument set, and TEM accessories while simultaneously suctioning out blood, secretions, smoke, or CO2 gas from the rectal cavity and to clear the telescope window. The TEM instrument set and its endoscopic TEM accessories must be selected in such a way that the product dimensions correspond to the anatomical conditions. The products are exclusively intended for use by specialized medical experts and may only be used by adequately qualified and trained medical personnel.

3.1

LAPARO-CO2-PNEU (performance characteristics) ⊳ for pressure-controlled distension of the rectum (rectal cavity and lower part of the sigmoid) with CO2 gas.

3.2

TEM PUMP (performance characteristics) ⊳ for continuous measurement of rectal pressure ⊳ for continuous suction of blood, secretions, smoke, or CO2 gas ⊳ for clearing of the telescope window with sterile saline solution

CAUTION Product failure during therapeutic use Interruption of therapeutic use n In therapeutic applications a second product with the same features should be available as a backup.

3.3

TEM irrigation cannula ⊳ for controlling the irrigation fluid flow and for rinsing the stereo or documentation telescope

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3.4

TEM tube set ⊳ for connection or insufflation, rinsing, suction between TEM combination system and TEM instrument set

3.5

TEM stereo telescope and documentation telescope / documentation telescope, eyepiece in 12 o'clock position / PANOVIEW telescope 30° and 50° ¯ TEM stereo telescope and documentation telescope with fixed and adjustable eyepiece part consisting of: TEM basic telescope and documentation telescope with fixed eyepiece part

Adjustable eyepiece part. Covering cap (against current discharge) Covering cap (against external light) TEM basic telescope with fixed and inserted adjustable eyepiece part ⊳ for spatially visualizing the operating area. The interocular distance is adjustable using the adjusting wheel. ⊳ for optics rinsing via Luer connector, small ⊳ for insufflation of CO2 gas via Luer connector, large

Documentation telescope, eyepiece in 12 o'clock position ⊳ for videomonocular visualization of the operating area ⊳ for connection of video camera and work / documentation via the monitor

Covering cap (against current discharge) ⊳ for insulation against electrical conduction during the use of HF due to contact between TEM stereo telescope and the user's nose. The covering cap is not removable.

Covering cap (against external light) ⊳ to protect from external light when working with the TEM stereo telescope without camera. The covering cap is removable. Documentation telescope, eyepiece in 12 o'clock position ⊳ for videomonocular visualization of the operating area ⊳ for connection of video camera and work / documentation via the monitor PANOVIEW telescope 30° and 50° ⊳ for monocular visualization of the operating area ⊳ for connection of video camera and work / documentation via the monitor

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3.6

TEM instrument set comprising: 1. Rectoscope tube: ð serves as a working channel 2. Obturator ð for atraumatic insertion of the rectoscope tube into the rectum 3. Basic part ð for fastening the rectoscope tube and the obturator 4. Adapter with observation window ð for sealing, observation, and adjusting the operating field 5. Working insert ð for attaching and fastening – TEM stereo telescope and documentation telescope, irrigation and insufflation insert, irrigation and insufflation outer tube set, silicone sealing insert ð For inserting auxiliary instruments 6. Silicone sealing insert ð for changing instruments of different diameters under minor gas loss with one large and two smaller, flexible passages 7. Irrigation and insufflation insert ð for mounting and fastening the documentation telescope ð for rinsing the documentation telescope via Luer connector, small ð for illuminating the operating area ð for insufflation of CO2 gas in the rectal cavity via Luer connector, large 8. Irrigation and insufflation outer tube set ð for mounting and fastening the PANOVIEW telescope 30° or 50° ð for rinsing the PANOVIEW telescope 30° or 50° via Luer connector, small ð for insufflation of CO2 gas in the rectal cavity via Luer connector, large 9. U-shaped support arm see instruction manual GA-B252 "U-shaped support arm" (GEOMED MedizinTechnik)

U-shaped support arm ⊳ for mounting and fastening the basic part 8840.20 in the universal retractor holder ⊳ for fastening the U-shaped support arm in the desired position by means of a handle on the central joint

Clamp socket, insulated ⊳ for fastening on the rail on the operating table ⊳ for holding and fastening the U-shaped support arm at the desired height

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3.7

TEM accessories 1. Double bulb ð for unfolding the bowel when setting the surgical field under visual view 2. Disposable filter insert ð prevents microorganisms from entering the double bulb 3. TEM clip applicator ð for the application of an initial and final clamp as a knot substitute when creating a continuous wound closure suture using absorbable suture material 4. Titanium clip / connecting part / ejector Titanium clip ⊳ the knot substitute is used to secure the surgical suture used to close surgical wounds until the wound heals or the suture thread is absorbed.

Connecting part ⊳ for removing the titanium clip from the sterile packaging and setting it in the TEM clip applicator. The clip adheres to the profile of the connecting part due to self-locking.

Ejector ⊳ for removing unapplied clips from the TEM clip applicator. Needle holder ⊳ for securing and transferring curved needles, e.g., ETHICON SH 2–0 ⊳ for the creation of surgical sutures HF knife, unipolar ⊳ for coagulation and cutting (e.g., resection and dissection of mucosa and tissue) by means of high-frequency current under endoscopic view Retractable needle ⊳ for the injection of tissue parts to be removed Reprocessing basket ⊳ for safe, gentle exposure of TEM stereo telescope and documentation telescope during – transport – reprocessing – sterilization – storage

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3.8

Important surgical information NOTE The literature listed provides an overview of TEM in recent years. The references listed below are taken from the relevant literature.

⊳ Broad-based adenomas are predominantly found in the rectum and lower sigmoid. ⊳ For lesions that are located in the intraperitoneal recto-sigmoidal region, partial wall excision (separating the annular from the longitudinal muscle layer) is advised to reduce the risk of perforation. Excision of the entire bowel wall thickness is recommended only for lesions in the extraperitoneal rectal region. ⊳ For circularly growing adenomas, segmental resection is recommended. ⊳ CAUTION is advised when removing tumors from the anterior rectal wall. The close proximity of the vagina to the anterior wall increases the risk of rectovaginal fistulas in women or prostate bleeding in men. ⊳ Suture dehiscence is cited as the most common complication of the TEM procedure. ⊳ It is recommended that patients undergo annual follow-up examinations after removal of adenomas or examinations at three-month intervals for the first two years after local excision of carcinomas has been performed. Long-term studies evaluating recurrence rates in the treatment of invasive carcinomas are needed to confirm efficacy.

4

Side effects

4.1

TEM accessories ¯ Titanium clip ð The titanium clip may occasionally become embedded, especially if it is not positioned correctly. ð Artifact formation in imaging procedures, such as MRI.

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5

Indication and scope TEM is indicated for wide-based rectal adenoma and for early rectal carcinoma. Rectal adenoma can be removed with a mucosectomy or the full thickness technique in the extraperitoneal rectal wall. Early carcinomas should always be removed with the full thickness of the wall. In principle, TEM can also be used in the rectum and sigmoid colon, which can be reached with the surgical rectoscope.

NOTE Before the first use, we recommend reading the relevant literature in addition to participating in a surgery course.

Subject to as yet unknown findings, expert opinion suggests that the following indications may indicate TEM: ⊳ histologically confirmed broad-based adenomas in the rectum and lower sigmoid; ⊳ histologically confirmed, well or moderately differentiated carcinomas whose stage was determined preoperatively to be CSI or T1 carcinoma and that are confined to the submucosa; and ⊳ histologically confirmed, well or moderately differentiated carcinomas whose stage was determined preoperatively to be T2 stage in patients older than 70 years or younger patients with high risk factors.

6

Contraindications TEM is contraindicated in patients who have a general contraindication against surgical procedures, suffer from severe infections, and/or severe metabolic disorders. CJD – Creutzfeldt Jakob Disease or vCJD – Variant of Creutzfeldt Jakob Disease BSE - Bovine Spongiform Encephalopathy; so-called mad cow disease (e.g., Creutzfeldt-Jakob disease) TSE - Transmissible Spongiform Encephalopathy The responsible physician must decide on the basis of the patient's general condition whether the intended use is possible or not. The country-specific laws and regulations must be complied with. For further information, please refer to the most recent medical literature. There are currently no known contraindications directly related to the product. Precautions: It is highly recommended to use a hydrophobic bacteria filter to prevent the transmission of microorganisms between patients.

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Combinations The system is used in conjunction with: 1. 2. 3. 4. 5.

light projectors and fiber light cables video cameras lenses HF surgical devices endoscopic accessories ð 18 Technical data and order data

WARNING Risk of intrarectal excess pressure when using a second gas source! When using argon plasma coagulators, additional visual or manual pressure monitoring by the user is required because the pressure monitoring and ventilation of the LAPARO-CO2-PNEU may be deactivated, e.g., due to a kinked insufflation tube or a closed instrument stopcock. The preselected gas flow rates of the argon plasma coagulator should not exceed 2 l/min. Activate the argon plasma coagulator only briefly.

WARNING Risk of life-threatening gas or air embolism! Purge the connection tubes with a sufficient amount of CO2 before use. The use of devices using additional gaseous media in combination with the TEM combination system or LAPARO-CO2-PNEU is exclusively the responsibility of the user.

CAUTION Incorrect combination of products! Injuries to the patient, user, or others, as well as damage to the product are possible. Different products may only be used together if their intended uses and relevant technical data (working length, diameter, peak voltage, etc.) are the same. The instruction manuals for products used in the product combination must be observed (see section 18 Technical data and order data).

The adapter on the endoscope side can be unscrewed and replaced by other suitable adapters for connecting fiber light cables made by other manufacturers. For order data, please refer to the latest catalog pages.

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7.1

Equipotentality The potential equalization cable represents a direct connection between a medical electrical device and a potential equlization rail. It serves to equalize differences in potential between enclosures of electrical equipment and firmly installed conductive parts in the patient environment.

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7.2

Requirements for the products / components of a combination The general requirements depend on whether the products/components are inside or outside the patient environment.

Medically used room within the patient environment

outside the patient environment -------

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Non-medically used room

Requirements / measures Leakage currents to IEC/EN 60601-1

-------

Measurement of leakage currents a) additional protective earth connection (to be clarified with the corresponding manufacturer), or b) additional isolating transformer **

-------

Measurement of leakage currents a) no plugs with metal housing, or b) additional separating device (to avoid voltage differentials)

19

Medically used room within the patient environment

outside the patient environment

Non-medically used room

Requirements / measures Leakage currents to IEC/EN 60601-1 Verification of leakage currents a) joint protective earth connection, or b) additional protective earth connection at MP (verify with the corresponding manufacturer), or c) additional separating device (to avoid voltage differentials), or d) no plugs with metal housing in the patient environment

additional "isolating transformer with galcanic separation to IEC/EN 60601-1 **

additional isolating device to IEC/ EN 60601-1

Multi-socket strip*

----

Functional connection

Power supply grid

MP

= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1

NMP

= non-medical electrical device in accordance with product-specific IEC/EN/UL standards

*

When connected via the same multiple socket strip under standard conditions, the earth leakage current of the socket strip must not exceed 5 mA.

**

e.g. Richard Wolf video cart with "isolating transformer"

Only connect devices with a safety extra-low voltage of no more than 60 V DC / 42.4 V AC peak to the connectors for electrical connections, i.e. the signal inputs and outputs.

ATTENTION 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 choosing the system components make sure that these meet the necessary requirements for the medical environment they are used in, in particular IEC/EN 60601-1. 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.

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