Storz UG110 User manual

Instructions for use
COR equipment cart series
en

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.
11-2020

Table of contents
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 3
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

Table of contents
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 4
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

General information
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 5
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.

General information
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 6
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.

Normal use
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 7
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.

Safety
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 8
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.

Safety
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 9
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. High-
frequency 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.

Safety
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 10
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.

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 11
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 plug-
in 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.
12
4
3
5
6
7
9
10
8
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)

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 12
4.2.1.1 Configuration examples
4
1
2
3
1 Equipment cart, wide, high (UG220) 3 Equipment cart, narrow, small (UG110)
2 LC equipment cart (UG230) 4 Equipment cart, narrow, high (UG120)

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 13
4.2.2 Boom package
4
123
1 Energy boom 3 Side boom, left
2 Transport handles 4 Side boom, right
4.2.3 Base module
1234
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

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 14
4.2.5 Isolation transformer
4
2
1
35
6
7
8
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
4
1
2
3
1 Control and display element 3 Test plug
2 Evaluation element 4 Connector for isolation transformer

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 15
4.2.7 Holders for monitors and navigation cameras
4
123
Monitor swivel arm (UG540)
1 Fastening on the equipment cart 3 Holding arm
2 Swivel arm 4 Holder
4.2.7.1 Holder models
4
12
3
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)

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 16
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.
124
3 5
1 Placement space 4 Lock
2 Cable slot 5 Tool-free attachment
3 Drawer
4.3.3 Pull-out elements
123
1 Sliding tray holder, narrow (UG610) 3 Keyboard shelf, narrow/wide (UG605/
UG6060)
2 Sliding tray holder, wide (UG611)

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 17
4.3.4 Holders for endoscopes
12 3
1 Flexible endoscopes (29005IFH) 3 Double videoendoscope (13991DET)
2 Videoendoscope (13991ET)
4.3.5 Equipment rails
1
2
1 Equipment rail, short (UG607) 2 Equipment rail, long (UG608)

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 18
4.3.6 Holders for special applications
4
1
23
5
6
7
8
910 11
1512 13 14 16
3
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)

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 19
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
12
1 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

Product description
Instructions for use • COR equipment cart series • KXH353_EN_V1.0_11-2020_IFU_CE-MDR 20
4.4.2 Boom package
Designation UG040 UG041 UG050 UG051 UG055 UG052
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 22.5kg
Side boom
(W x H x D)
55 x 992 x 45mm 55 x 1,154 x 45mm
Power connec-
tion
115V 230V 115V 230V 230V 230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
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
4.4.4 Cover
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
4.4.5 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