COR equipment cart series Instructions for use Ver 1 Nov 2020

11-2020 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.

Table of contents

Table of contents 1 General information... 5 1.1 Read the instructions for use ... 5 1.2 Scope... 5 1.3 Description of warning messages... 5 2 Normal use... 7 2.1 Intended use ... 7 2.2 Indications... 7 2.3 Contraindications... 7 2.4 Target user populations ... 7 2.5 Patient groups... 7 3 Safety ... 8 3.1 Serious incidents ... 8 3.2 Correct handling ... 8 3.3 Correct reprocessing ... 8 3.4 Dangers from electrical current... 8 3.5 Damage due to ingress of liquid in electrical components... 9 3.6 Electromagnetic interference ... 9 3.7 Failure of devices ... 10 4 Product description ... 11 4.1 Description of operation ... 11 4.1.1 Equipment cart ... 11 4.1.2 Isolation transformer with earth leakage monitor ... 11 4.2 Product overview ... 11 4.2.1 Equipment cart ... 11 4.2.2 Boom package ... 13 4.2.3 Base module... 13 4.2.4 Cover ... 13 4.2.5 Isolation transformer... 14 4.2.6 Earth leakage monitor... 14 4.2.7 Holders for monitors and navigation cameras... 15 4.3 Possible combinations... 16 4.3.1 Shelf... 16 4.3.2 Drawer unit ... 16 4.3.3 Pull-out elements... 16 4.3.4 Holders for endoscopes ... 17 4.3.5 Equipment rails ... 17 4.3.6 Holders for special applications ... 18 4.3.7 Counterweights... 19 4.4 Technical data... 19 4.4.1 Equipment cart ... 19 4.4.2 Boom package ... 20 4.4.3 Base module... 20 4.4.4 Cover ... 20 4.4.5 Drawer unit ... 20 4.4.6 Shelf... 21 4.4.7 Holders for monitor and navigation camera ... 21 4.4.8 Holders for endoscopes ... 21 4.4.9 Holders for special applications ... 21 4.4.10 Pull-out elements... 22 4.4.11 Equipment rails ... 23 4.4.12 Counterweights... 23 4.4.13 Isolation transformer... 23 4.4.14 Earth leakage monitor... 24

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Table of contents

4.5

Symbols employed ... 25 4.5.1 Symbols on the packaging ... 25 4.5.2 Symbols on the product ... 26 4.6 Ambient conditions ... 26 4.7 System description ... 27 4.7.1 Definition... 27 4.7.2 Application area... 27 4.7.3 Combination with non-medical products ... 27 4.7.4 Permissible system load... 27 4.7.5 Multiple socket outlets... 28 4.7.6 Installation of the ME system... 28 4.7.7 Commissioning the ME system ... 28 4.7.8 Maintenance ... 29 5 Preparation... 30 5.1 Assembling the product... 30 5.2 Installing the shelf or drawer... 30 5.3 Setting up the product ... 30 5.3.1 Securing the product ... 30 5.3.2 Securing devices ... 30 5.4 Loading the product ... 31 5.5 Unloading the product ... 31 5.6 Moving the product... 31 5.7 Connecting the product ... 32 5.8 Connecting devices ... 32 5.9 Connecting the earth leakage monitor... 33 5.10 Testing the system with the test plug ... 33 6 Disassembly... 35 6.1 Disconnecting the product from the power supply ... 35 6.2 Removing the shelf or drawer ... 35 7 Maintenance, servicing, repairs, and disposal... 36 7.1 Maintaining the product ... 36 7.1.1 Maintenance ... 36 7.2 Changing the fuse on the isolation transformer... 36 7.3 Safety inspection in accordance with IEC 62353 ... 36 7.3.1 Visual inspection... 37 7.3.2 Electric measurements ... 37 7.3.3 Functional test ... 37 7.4 Repairing the product ... 37 7.5 Disposing of the products... 37 8 Accessories and spare parts ... 39 8.1 Accessories... 39 8.2 Spare parts ... 39 9 Electromagnetic compatibility... 42 9.1 Table 1 – Compliance level for immunity tests ... 42 9.2 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 43 9.3 Table 3 – Test levels for radiated and conducted immunity tests ... 44 9.4 Table 4 – Emission class and group ... 45 9.5 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 46 10 Faults and messages ... 47 10.1 Fault correction ... 47 11 Subsidiaries... 49

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General information

1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, or third parties may be injured. In addition, the product may be damaged. 1.

Read the instructions for use of the product carefully and follow them completely.

2.

Keep the instructions for use clearly visible next to the product.

3.

Observe the instructions for use of products used in combination.

It is recommended to check the suitability of the products for the planned procedure prior to use.

1.2 Scope This instruction manual is valid for: Product

Article number

Equipment cart, narrow, small

UG110

Equipment cart, narrow, high

UG120

Equipment cart, wide, high

UG220

LC equipment cart

UG230

Equipment cart boom package, high

UG051

Monitor holder

UG500

Monitor holding arm, long

UG520

Isolation transformer 200–240 V, 2,000 VA

UG310

LC equipment cart boom package

UG052

Earth leakage monitor 200–240 V

UG410

Monitor swivel arm

UG540

Monitor holding arm

UG510

Isolation transformer 100–120 V, 2,000 VA

UG300

Equipment cart boom package, small

UG041

Equipment cart boom package, small, 115 V

UG040

Boom package, high, CH version

UG055

Equipment cart boom package, high, 115 V

UG050

Swivel arm for navigation camera

UG530

Earth leakage monitor 100–120 V

UG400

1.3 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger.

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General information

WARNING WARNING Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

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Normal use

2 Normal use 2.1 Intended use Transport system for devices and accessories. –

Duration of use: Short-term; continuous use for ≤ 30 days

–

Invasiveness level: Non-invasive; equipment carts do not come into direct contact with the patient during use

2.2 Indications Based on their intended purpose, equipment carts are not designed for use on people. Indications and contraindications cannot be defined, and therefore cannot be applied to equipment carts.

2.3 Contraindications Based on their intended purpose, equipment carts are not designed for use on people. Indications and contraindications cannot be defined, and therefore cannot be applied to equipment carts.

2.4 Target user populations The medical device may only be used by doctors and medical assistants with a relevant specialist qualification.

2.5 Patient groups There are no restrictions in terms of patient groups for this product.

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Safety

3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): –

Death of a patient, user, or another person

–

Temporary or permanent serious deterioration in the medical condition of a patient, user, or another person

–

A serious threat to public health The manufacturer and appropriate authority must be notified of all serious incidents.

3.2 Correct handling If the product is not handled correctly, patients, users, and third parties may be injured. Only persons with the necessary medical qualification and who are acquainted with the application of the product may work with it. Do not convert or modify the product. Make sure that medical devices do not slide around on the product and fall off. In order to protect persons from falling devices, secure the devices on the product with the stabilizing elements. Only use the product if it is secured with the brakes. Pay attention to the loading capacity of the connected devices, irrespective of the maximum load of the product and its components. When moving the product, look out for baseboards, door frames, protruding cables, etc. as the product could collide with them or they could cause it to tip over. When moving the product, make sure that movable devices do not slide around and monitor arms do not swivel outwards.

3.3 Correct reprocessing Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection. Reprocess the product before use. A validated reprocessing procedure must be followed and the product must be reprocessed in line with the reprocessing instructions.

3.4 Dangers from electrical current An improper power supply may cause an electric shock and injure patients, users, or third parties. Defective cables and plugs may result in smoke and fires. All electrical installations of the operating room in which the product is connected and used must meet the applicable IEC standards. Use either the power cord supplied by KARL STORZ or a power cord which has the same properties and which bears a national mark of conformity. The product may only be operated with the line voltage stated on the rating plate. The product must only be operated with the specified input voltages and input frequencies. Position the product appropriately so that the power cord can be unplugged at any time. The product is only voltage-free when the mains plug has been disconnected.

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Safety

The product’s ground line should be installed by a qualified electrician. Ensure potential equalization according to the applicable national rules and regulations. To ensure reliable protective earth grounding, connect the product to a properly installed socket that is approved for use in the operation room. Routinely inspect the electrical plug and cord and do not use if the inspection reveals damage. Connect the product to a power supply with protective conductor. Do not use any additional multiple socket outlets or extension cables. Do not use freely accessible multiple socket outlets. Multiple socket outlets must not be placed on the floor. In the case of electrical products, individual components or the product itself may be live. Live parts can cause electric shocks in the event of contact and injure patients, users, and third parties. Do not touch the patient and the non-medical electrical devices at the same time. Have servicing carried out by KARL STORZ or a company authorized by KARL STORZ. Failure to observe this will void the guarantee. Always pull out the mains plug before carrying out any cleaning and maintenance work.

3.5 Damage due to ingress of liquid in electrical components In the case of electrical products, individual components or the product itself may be live. Liquid ingress into an electrical product may result in a short circuit or an unintentional transfer of current. The product is damaged as a result and patients, users and third parties may be injured. Do not store liquids near the product or on the product. If liquid has entered the product, pull out the plug and allow the product to dry completely.

3.6 Electromagnetic interference Medical electrical products are subject to special precautions regarding electromagnetic compatibility and must be installed and commissioned according to the tables on electromagnetic compatibility. If other products (e.g., for MRT, CT, diathermy, electrocautery, or RFID) emit electromagnetic radiation, the function of the product may be impaired. Highfrequency communication equipment can affect medical electrical products and impair their performance. Do not use the product in the vicinity of a magnetic resonance tomograph (MRT). Do not use the product next to or together with other devices. If such use is required, monitor the product and the other devices, and follow the relevant instructions for use in the event of malfunctions. Portable RF communications equipment including peripheral devices (e.g., antenna cables and external antennas) should be used no closer than 30 cm from the product, including cables specified by the manufacturer. Observe the information on electromagnetic compatibility; see chapter Electromagnetic compatibility [p. 42]. In case of uncertainties, seek expert advice from KARL STORZ. Before use, a clinical/biomedical engineer or an EMC specialist should carry out an ad-hoc test of the electromagnetic radiation. To prevent increased electromagnetic emissions or reduced electromagnetic immunity of the product, only use accessories, transducers, and cables recommended or supplied by the manufacturer.

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Safety

3.7 Failure of devices The components of the product may fail during use. Have replacement products ready for each application or plan for an alternative surgical technique.

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Product description

4 Product description 4.1 Description of operation 4.1.1 Equipment cart The central power supply to the equipment cart is supplied via the energy boom. In the energy boom with a power supply, the power lines of the electrical devices placed on the cart are connected to the isolation transformer and the potential equalization lines are connected to the potential equalization rail.

4.1.2 Isolation transformer with earth leakage monitor The earth leakage monitor is a monitoring/signaling device and is connected via a special plugin connection to the isolation transformer. This ensures the safety of the electrical supply to devices on the equipment cart. The isolation transformer switches off automatically in the event of an overload and returns to operation once the temperature has cooled to 50 °C. The earth leakage monitor monitors the dielectric resistance. If the resistance drops below a value of 50 kΩ, acoustic and visual signals are issued. In addition to the isolation resistance, the operating temperature and power utilization of the isolation transformer are also monitored.

4.2 Product overview 4.2.1 Equipment cart The basic module of the COR equipment cart consists of the following components: cover, base plate with double castors, and boom package. Auxiliary modules can be added to the basic module. In this context, the requirements of CEI/ IEC 60347-7-710 must be observed by the operating organization.

1

2

3 4 5

10

6 7 8

9 UG210 equipment cart 1

Cover

6

Energy boom (boom package)

2

Central power switch

7

Drawer unit

3

Transport handles

8

Base module

4

Shelf

9

Isolation transformer

5

Side boom, right (boom package)

10

Side boom, left (boom package)

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Product description

4.2.1.1 Configuration examples 2 1

4 3

1

Equipment cart, wide, high (UG220)

3

Equipment cart, narrow, small (UG110)

2

LC equipment cart (UG230)

4

Equipment cart, narrow, high (UG120)

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Product description

4.2.2 Boom package 2

1

3

4

1

Energy boom

3

Side boom, left

2

Transport handles

4

Side boom, right

4.2.3 Base module

1

2

3

4

1

Base

3

Locking brake

2

Impact protection

4

Double swivel castor

4.2.4 Cover The cover consists of the following components: –

Frame with main power switch on right

–

Supply line to the distributor box/isolation transformer

–

Cable bushing for earth leakage monitor

–

9 elongated holes for fixing on the energy/side booms

–

Cable opening to the boom

–

Service flap with rubber lips

–

5 positions for monitor holding arms with blind plugs

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Product description

4.2.5 Isolation transformer

2

1

8

7

6

5

4

3

1

Fuse holder for device fuses

5

Potential equalization connector

2

Connection for main power switch

6

Power input connector

3

Connection for earth leakage monitor

7

Allen key

4

IEC connector sockets

8

Connection bridge

4.2.6 Earth leakage monitor

1

2 3 4 1

Control and display element

3

Test plug

2

Evaluation element

4

Connector for isolation transformer

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Product description

4.2.7 Holders for monitors and navigation cameras 4

3

2

1

Monitor swivel arm (UG540) 1

Fastening on the equipment cart

3

Holding arm

2

Swivel arm

4

Holder

4.2.7.1 Holder models 2

1

3

4

5

1

Monitor holding arm (UG520)

4

Monitor holder (UG500)

2

Monitor holding arm (UG510)

5

Monitor holder adaptor (UG501)

3

Monitor swivel arm, navigation camera (UG530)

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Product description

4.3 Possible combinations The COR equipment cart can be combined with the following components, depending on the size and version.

4.3.1 Shelf

4.3.2 Drawer unit Drawer units come in two different sizes depending on the cart version. The number of drawers can be individually defined and depends on the boom length.

1

2

3

4

5

1

Placement space

4

Lock

2

Cable slot

5

Tool-free attachment

3

Drawer

4.3.3 Pull-out elements

1

2

1

Sliding tray holder, narrow (UG610)

2

Sliding tray holder, wide (UG611)

3 3

Keyboard shelf, narrow/wide (UG605/ UG6060)

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Product description

4.3.4 Holders for endoscopes

2

1

1

Flexible endoscopes (29005IFH)

2

Videoendoscope (13991ET)

3

3

Double videoendoscope (13991DET)

2

Equipment rail, long (UG608)

4.3.5 Equipment rails 1

2

1

Equipment rail, short (UG607)

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Product description

4.3.6 Holders for special applications

3

1 2

4

3

5

7

6 8

9

12

13

14

15

10

16

11

17

1

Footswitch holder for one-pedal footswitch (29005EFH)

10

Multifunctional holder, long (UG623L)

2

Adaptor plates for CO2 bottle holder, twin (UG627)

11

Cable manager (UG619)

3

CO2 bottle holder (UG609)

12

Tube clip (UG631)

4

IV pole (UG616/UG625)

13

Bracket (UG630)

5

IV pole, height adjustable (UG617/ UG626)

14

Footswitch holder for two-pedal footswitch (29005DFH)

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Product description

6

Holder for support element (UG613)

15

Plug receptacle for videoendoscopes (UG618)

7

Camera holder (UG612)

16

Multifunctional holder (UG623)

8

Pump holder (UG624)

17

COR service cover, narrow/wide (UG628/UG629)

9

Camera holder (UG622)

4.3.7 Counterweights 1

1

2

Counterweight plate (UG614)

2

Additional weight (UG615)

4.4 Technical data 4.4.1 Equipment cart Designation

UG110

UG120

UG210

UG220

UG230

Dimensions (W x H x D)

660 x 1,265 x 730 mm

660 x 1,474 x 730 mm

840 x 1,265 x 730 mm

840 x 1,265 x 730 mm

840 x 1,449 x 730 mm

Weight

68 kg

74 kg

78 kg

86 kg

79.5 kg

Boom package

UG40, UG41

UG50, UG51

UG40, UG41

UG50, UG51

UG52

Cover

UG020

UG020

UG021

UG021

UG022

Base module

UG010

UG010

UG011

UG011

UG012

Castor diameter

150 mm

150 mm

150 mm

150 mm

125 mm

Max. total weight

275 kg

275 kg

Max. load

189 kg

189 kg

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Product description

4.4.2 Boom package Designation

UG040

UG041

Energy boom (W x H x D)

580 x 992 x 130 mm

580 x 1,154 x 130 mm

Weight

23.5 kg

25.5 kg

Side boom (W x H x D)

55 x 992 x 45 mm

55 x 1,154 x 45 mm

Power connection

115 V

115 V

Max. load for multiple socket outlet

15 A/110 V 16 A/230 V 15 A/110 V 16 A/230 V 16 A/230 V 16 A/230 V

230 V

UG050

UG051

UG055

UG052

22.5 kg

230 V

230 V

230 V

4.4.3 Base module Designation

UG010

UG011

UG012

Dimensions (W x H x D)

660 x 235 x 730 mm

840 x 235 x 730 mm

840 x 210 x 730 mm

Weight

23 kg

25 kg

24.2 kg

Castor diameter

150 mm

150 mm

125 mm

Equipment cart

Narrow

Wide

LC

Designation

UG021

UG020

UG022

Dimensions (W x H x D)

740 x 85 x 520 mm

560 x 85 x 520 mm

560 x 85 x 520 mm

Weight

15 kg

14 kg

14.2 kg

Equipment cart

Wide

Narrow

LC

4.4.4 Cover

4.4.5 Drawer unit Designation

UG601

UG602

Dimensions (W x H x D)

450 x 126 x 510 mm

630 x 126 x 510 mm

Weight

11.3 kg

13 kg

Max. load for drawer

5 kg

5 kg

Max. load for placement space

60 kg

60 kg

Equipment cart

Narrow

Wide

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