Storz ARTip CRUISE UR500B User manual

Instructions for use
ARTip CRUISE™
UR500B, UR500C
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.
03-2021

Table of contents
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................5
1.1 Read the instructions for use.................................................................................................................... 5
1.2 Description of warning messages.............................................................................................................5
1.3 Open-source software requests ...............................................................................................................5
2 Normal use....................................................................................................................................................6
2.1 Intended purpose......................................................................................................................................6
2.2 Indications.................................................................................................................................................6
2.3 Contraindications......................................................................................................................................6
2.4 Target user populations ............................................................................................................................ 6
2.5 User qualifications ....................................................................................................................................6
2.6 Target patient groups ...............................................................................................................................7
2.7 Intended conditions of use .......................................................................................................................7
3 Safety ............................................................................................................................................................8
3.1 Serious incidents ......................................................................................................................................8
3.2 Unsterile product ......................................................................................................................................8
3.3 Combination with other components .......................................................................................................8
3.4 System configuration ................................................................................................................................ 8
3.5 Risks from electrical current .....................................................................................................................8
3.6 Applied part, type BF ................................................................................................................................9
3.7 Correct handling .......................................................................................................................................9
3.8 Replacement system ................................................................................................................................9
3.9 Active safety information ..........................................................................................................................9
4 Product description ....................................................................................................................................11
4.1 Device overview ......................................................................................................................................11
4.2 Symbols on the packaging .....................................................................................................................12
4.3 Symbols on the device ...........................................................................................................................13
4.4 Scope of supply ......................................................................................................................................13
4.5 Possible combinations............................................................................................................................14
4.6 Technical data.........................................................................................................................................14
4.7 Storage and usage conditions ................................................................................................................15
4.8 Standards, directives and regulations ....................................................................................................15
5 Preparation..................................................................................................................................................17
5.1 Unpacking the product ...........................................................................................................................17
5.2 Taking the ARTip CRUISE™ out of the packaging.................................................................................17
5.3 Installing the monitor ..............................................................................................................................20
5.4 Initial commissioning ..............................................................................................................................21
5.5 Installing the VITOM® 3D adaptor ...........................................................................................................24
5.6 Setting up the device ..............................................................................................................................25
5.7 Creating the connections........................................................................................................................25
5.7.1 Operation with HF surgical equipment ........................................................................................ 26
5.8 Putting into service .................................................................................................................................26
5.9 Placing the VITOM® 3D into the holding arm..........................................................................................28
5.10 Securing cables to the holding arm ........................................................................................................ 29
5.11 Connecting the VITOM®3D ....................................................................................................................29
5.12 Configuring the touchscreen settings.....................................................................................................30
5.13 Attaching the IMAGE1 PILOT .................................................................................................................32
5.14 Attaching a sterile drape to the ARTip CRUISE™ ..................................................................................33
5.15 Attaching a sterile drape to the IMAGE1PILOT ....................................................................................35
5.16 Attaching sterile drapes to the ARTip CRUISE™ cart ............................................................................35
6 Operation ....................................................................................................................................................36

Table of contents
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 4
6.1 Control options for the holding arm........................................................................................................36
6.2 Function of the various switches ............................................................................................................36
6.3 Visual status displays..............................................................................................................................37
6.4 Acoustic status displays .........................................................................................................................37
6.5 Selecting the initial position of the holding arm......................................................................................37
6.6 Controlling the ARTip CRUISE™ with IMAGE1 PILOT ........................................................................... 39
6.7 Manually controlling the ARTip CRUISE™ .............................................................................................40
6.8 Arm safety lock .......................................................................................................................................40
6.9 Saving a position ....................................................................................................................................41
6.10 Emergency setting ..................................................................................................................................43
6.11 System setup ..........................................................................................................................................44
7 Reprocessing ..............................................................................................................................................52
7.1 General warnings ....................................................................................................................................52
7.2 Manual wipe-down disinfection ..............................................................................................................53
7.3 Assembly, inspection and care...............................................................................................................53
7.4 Reprocessing limits.................................................................................................................................53
8 Maintenance, repair, and disposal..............................................................................................................54
8.1 Servicing and repair ................................................................................................................................ 54
8.2 Safety inspection IEC62353...................................................................................................................54
8.3 Repairing products .................................................................................................................................55
8.4 Infection prevention ................................................................................................................................55
8.5 Disposing of the product ........................................................................................................................55
9 Accessories and spare parts ......................................................................................................................56
9.1 Spare parts .............................................................................................................................................56
10 Electromagnetic compatibility.....................................................................................................................57
10.1 General notes on the operating environment .........................................................................................57
10.2 Table 1 – Compliance level for immunity tests ....................................................................................... 57
10.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ....................... 59
10.4 Table 3 – Test levels for radiated and conducted immunity tests ..........................................................59
10.5 Table 4 – Emission class and group ....................................................................................................... 61
10.6 Table 5 – Recommended separation distances between portable and mobile HF communications
equipment and the product ....................................................................................................................61
11 Appendix.....................................................................................................................................................62
11.1 Dimension sketches................................................................................................................................62
12 Subsidiaries.................................................................................................................................................66

General information
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_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 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.
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.
1.3 Open-source software requests
To obtain a copy of the source code being made publicly available by KARLSTORZ in
connection with the open source software used in this KARLSTORZ device, you should send
your request, along with the equipment part number and serial number, either via email to
[email protected] or by post to
KARL STORZ Imaging, Inc.
Attention: Open Source Software Inquiries
1 S. Los Carneros Goleta,
CA 93117 USA

Normal use
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 6
2 Normal use
2.1 Intended purpose
Intended purpose of the motorized holding arm
Depending on the instrument adaptor selected, the motorized holding arm is used for short-
term flexible positioning and dynamic movement of compatible KARLSTORZ equipment
during open, microsurgical and minimally invasive interventions. The motorized holding arm
does not come into contact with the patient and is therefore non-invasive.
Intended purpose of the exoscope adaptor for motorized holding arm
The exoscope adaptor serves to secure KARL STORZ exoscopes to the motorized holding arm
for short-term use in open, microsurgical and minimally invasive interventions. The exoscope
adaptor does not come into contact with the patient and is therefore non-invasive.
2.2 Indications
The ARTip CRUISE™ is indicated for holding exoscopes or overview cameras during
microsurgical or open interventions in order to guarantee a stable camera image and a stable
view of the site.
USA indications
The motorized holding arm is an accessory for VITOM® exoscopes. It is used for short-term
flexible positioning and dynamic movement of VITOM® exoscopes during open or
microsurgical applications.
The exoscope adapter is used to mount VITOM® exoscope on the motorized holding arm, for
short-term use during open, microsurgical or minimally invasive applications.
2.3 Contraindications
There are no known contraindications relating directly to the equipment. Use of the
ARTipCRUISE™ is contraindicated if, in the opinion of the responsible physician, the patient's
health is endangered through its use.
2.4 Target user populations
The product may only be used by doctors and medical assistants with a relevant specialist
qualification who have received training on the product.
Training may only be provided by persons equipped to do so on the basis of their knowledge.
Your local representative or responsible KARLSTORZ member of staff is available to provide
training and information on other training alternatives.
2.5 User qualifications
Only physicians and medical support staff with a relevant specialist qualification and who have
received training on the product may use the product. Only persons with appropriate specialist
training may provide training. The user profile includes the following characteristics:
– Recognized medical qualification of the user (specialist physician, qualified medical staff)
– Adequate powers of comprehension to rationally assess the current surgical situation
– Adequate language skills in the languages used in the instructions for use
– Completion of thorough instruction in the operation and use of the medical device
– Knowledge of the contents of the instructions for use

Normal use
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 7
– No physical impairments that could diminish perception of activation and alarm signals
(visual and acoustic)
2.6 Target patient groups
Gender No restriction
Age No restriction
Weight No restriction
Medical condition Suitable for the treatment, taking into account the indications
and contraindications, in the opinion of the physician
2.7 Intended conditions of use
The product may only be used in hospitals in suitable ambient conditions. For information on
ambient conditions, see section on storage and usage conditions.

Safety
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_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 Unsterile product
The product is not sterile when delivered. The use of unsterile products poses a risk of
infection for patients, users, or third parties.
Before use, reprocess the product in line with the reprocessing instructions.
3.3 Combination with other components
Combination of the product with unsuitable instruments and devices can result in uncontrolled
behavior and injury to patients, users, and third parties.
Only combine the device with instruments and equipment that are approved for joint use.
Observe the instructions for use and interface specifications of the combined devices and
system components.
Only use approved accessories.
3.4 System configuration
Additional equipment that is connected to electrical medical equipment must conform to the
respective IEC or ISO standards (e.g., IEC 60950 for data processing equipment). Furthermore,
all configurations must satisfy the requirements for medical electrical systems (see
IEC60601-1-1 or paragraph16 of the 3rd Ed. of IEC 60601-1). Anyone who connects
additional equipment to electrical medical equipment is configuring a medical system, and is
therefore responsible for ensuring that this system satisfies the requirements for medical
electrical systems. It must be taken into account that local regulations take priority over the
aforementioned requirements. If in doubt, please contact your local representatives or
technical support.
3.5 Risks from electrical current
An improper power supply may cause an electric shock and injure patients, users or third
parties. All electrical installations of the operating room in which the device is connected and
operated must meet the applicable IEC standards.
Do not operate the product in explosive atmospheres.
Make sure there are no materials that are easily flammable or saturated with oxygen
(flammable fabrics, surgical gowns, gauze, etc.) near to the laser beam path.
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.
Ensure potential equalization according to the applicable national rules and regulations.

Safety
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 9
3.6 Applied part, type BF
The ARTip CRUISE™ is a type-BF applied part. If a type CF applied part is combined with a
type-BF applied part, this means that the type CF applied part also complies with the limit
values of type BF.
3.7 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.
Check that the product is suitable for the procedure prior to use.
Check the product for the following points before and after every use:
– Completeness
– Good working order
– Rough surfaces left inadvertently
– Sharp corners
– Burred edges
– Correct assembly of the components
– Functionality
Do not leave broken-off components inside the patient.
Do not overload the product with mechanical stress.
Do not bend bent products back to their original position.
3.8 Replacement system
If the entire system fails during a surgical procedure, it must be ensured that a replacement
system with the corresponding functionality can be introduced within a reasonable timeframe.
3.9 Active safety information
In order to guarantee the safety of persons in the working area of the ARTipCRUISE™ holding
arm, movements of the ARTipCRUISE™ are communicated to the environment at several
levels:
– Via text messages on the touchscreen and operating screen
– Via various acoustic signals
– Via optical signals from the illuminated ring
An overview of the safety information can be found in the table:

Safety
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 10
Activity Text message Optical
signal
Acoustic
signal
When the footswitch is
pressed, the ARTipCRUISE™
can be activated
ARTip CRUISE™ ac-
tive
Illuminated white <Confirmation>
acoustic signal
The user puts the AR-
TipCRUISE™ arm into motion
by inputting a command
ARTip CRUISE™ in
motion
Flashing white <In motion>
acoustic signal
The current position of the
holding arm is saved
The ARTip CRUISE™
position is saved
Flashing green <Confirmation>
acoustic signal
The saved position of the hold-
ing arm is retrieved
ARTip CRUISE™
moves to the saved
position
Flashing white <In motion>
acoustic signal
The saved position of the hold-
ing arm has been reached
ARTip CRUISE™ has
reached the saved
position
Flashing white <Confirmation>
acoustic signal
The maximum movement ra-
dius of the ARTip CRUISE™
has been reached; no further
movement possible in this di-
rection
ARTip CRUISE™ bor-
der reached: move in
opposite direction
Illuminated yel-
low
---
System movement is stopped
(predicted collision etc.)
ARTip CRUISE™
stopped: see ARTip
CRUISE™ monitor
Flashing red ---
System movement has been
stopped by the emergency
stop switch
ARTip CRUISE™:
emergency stop ac-
tive
Flashing red ---
Confirmation by control equip-
ment required to reactivate the
stopped system
ARTip CRUISE™ sys-
tem activation via
footswitch or switch
for manual mode
--- ---

Product description
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 11
4 Product description
4.1 Device overview
4
12
3
5
14
11
13
15
6
7
8
9
10
12
16
17
18
1 VITOM® 3D (not included in the scope of
supply)
10 Bracket for connecting cable
2 VITOM® 3D adaptor 11 Power switch
3 Switch for manual mode 12 Earth leakage monitor display field
4 Illuminated ring status display (UFD) 13 Breaker for earth leakage monitor warn-
ing signal
5 Serial port for illuminated ring cable 14 Holder for footswitch
6 Cable guide 15 Cover flap for connection panel
7 Touchscreen 16 Footswitch
8 Emergency stop switch 17 Air inlet
9 Release button* 18 Air outlet (bottom of equipment)

Product description
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 12
4.2 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Serial number
Article no.
Unsterile
Fragile, handle with care
Keep away from sunlight
Keep dry
Air pressure limit
Humidity limit
Temperature limit
Non-ionizing electromagnetic radiation
Consult instructions for use

Product description
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 13
Symbol Meaning
Medical device
CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable Regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
In accordance with US federal law (21 CFR 801.109), this product may
only be sold to or on prescription from a licensed physician.
4.3 Symbols on the device
Symbol Meaning
Follow instructions for use
Climbing prohibited
Type BF device
User feedback device
Potential equalization connector
Network connection
Power plug (direct current)
Input/output
4.4 Scope of supply
ARTip CRUISE™ SET UR 501 B/C
consisting of:
–ARTip CRUISE™ UR 500 B/C
–VITOM® 3D adaptor UR 002
ARTip CRUISE™ UR 500 B/C
consisting of:
– ARTip CRUISE™ cart with holding arm and monitor
– Footswitch
– Power cord

Product description
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 14
– Ethernet cable
4.5 Possible combinations
ATTENTION
Incompatible accessory! Malfunctions and damage to the device!
Only use the compatible accessories designated by KARLSTORZ.
Required accessories
– VITOM® 3D adaptor UR 002
Other accessories
To enable normal use, the ARTip CRUISE™ requires additional accessories which have their
own instructions for use:
Description Accessory art. no. Instructions for use art. no.
IMAGE1 PILOT* TC 014 97000166
VITOM® 3D TH 200 96206591D
IMAGE1 S CONNECT®
IMAGE1 S CONNECT® II
TC 200
TC 201 **
96206286D
IMAGE1 D3-LINK TC 302 ** 96206286D
Sterile cover for ARTip
CRUISE™
TH 001 97000169
Sterile cover for IMAGE1 PI-
LOT
041150-20 96306019DF
* For attachment to holding systems with KSLOCK
** Not all products are available in all regions
4.6 Technical data
General specification
ARTip CRUISE™ UR 500 B/C
External dimensions (W x H x D) (overall sys-
tem dimensions)
600–1265 x 1460–2360 x 840–1765mm
Arm length (nominal length) 850mm
Weight 175kg
Power input 350VA
Power supply for countries with 110V line
voltage (model UR 500C)
110–115VAC, 50/60Hz
Power supply for countries with 230V line
voltage (model UR 500 B)
220–230VAC, 50/60Hz

Product description
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 15
Monitor specifications
Display size 15.6"
Resolution 1366 x 768
Frequency (horizontal) 30–80kHz
Frequency (vertical) 50–75Hz
Contrast ratio 500:1 typical
Brightness 300cd/m2
Field of view (horizontal/vertical) 160° typical
Number of colors 16.7 million
IP degree of protection IP 52
DV input 24VDC
Dimensions (W x H x D) 392.9 x 242.3 x 48mm
Weight 3.1kg
4.7 Storage and usage conditions
ATTENTION
Improper storage may damage the product.
The described storage and usage conditions must be complied with.
Storage/transport conditions
ARTip CRUISE™ VITOM® 3D adaptor
Temperature -10–60°C
(14–140°F)
-10–60°C
(14–140°F)
Relative humidity
(non-condensing)
5–95% 5–95%
Air pressure 500–1080hPa 500–1080hPa
Operating conditions
ARTip CRUISE™ VITOM® 3D adaptor
Temperature 10–30°C
(50–86°F)
0–40°C
(32–104°F)
Relative humidity
(non-condensing)
20–80% 20–80%
Air pressure 500–1080hPa 500–1080hPa
Max. operating altitude 2000m 2000m
4.8 Standards, directives and regulations
Standard compliance
According to IEC60601-1+ A1, UL60601-1, CSAC22.2 No. 601.1-M90:
– Type of protection against electric shock: Protection Class I

Product description
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 16
– IP degree of protection: IP20
According to IEC60601-1-2, FCC-B:
Please read the Electromagnetic Compatibility information.
Directive compliance
According to the European Medical Device Regulation (MDR) EU
2017/745:
This medical device belongs to Class I
The code number after the CE mark indicates the responsible
notified body.

Preparation
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 17
5 Preparation
5.1 Unpacking the product
1. Carefully remove the product and accessories from the packaging.
2. Check the delivery for missing items and evidence of shipping damage.
3. In the case of damage, hidden defects, and short deliveries, document their nature and
extent and contact the manufacturer or supplier immediately.
4. Keep packaging for further transport.
5.2 Taking the ARTip CRUISE™ out of the packaging
Tools (not included in the scope of supply)
– Allen key
– Open-ended spanner or socket wrench 24 mm
Removing the tightening straps.
1. Open the tightening straps.
2. Remove the tightening straps around the packaging.
Removing the cover
CAUTION
Damage to the device due to falling packaging components!
The packaging cover consists of a wooden ramp for extracting the ARTip CRUISE™.
If the packaging box is removed when the wooden ramp is in place, this could fall and damage
the equipment.
Always remove the wooden ramp before removing the packaging box.
3. Remove the wooden ramp on the box.

Preparation
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 18
4. Lay the wooden ramp onto the front of the pallet. It will be needed later on when
removing the ARTip CRUISE™ from the pallet.
Removing the side parts
The side parts are held together by 3 plastic closures on the front and 3 on the back.
5. Pull the locking tabs upwards and out of the plastic closures.
6. Fold out the closures towards the front.
7. Pull the entire plastic closures out of the packaging box.
ðOnce all plastic closures have been removed from the front and back (3 in each case),
the front part of the packaging box can be removed.

Preparation
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 19
8. Then remove the packaging box at the back.
Removing the accessory boxes and foam parts
9. Remove the accessory boxes. The boxes contain the footswitch, the monitor and other
accessories.
10. The holding arm is secured with 2 securing straps, one on the cart push handle and one
around the entire cart. Undo and remove both securing straps.
11. Also remove the securing strap board.
12. Remove the foam parts attached to protect the ARTip CRUISE™ during transportation. It
is possible to remove the foam parts underneath the holding arm once the holding arm
has been removed from the transport position.
Removing the wheel relief board
13. The wheel relief board is screwed into the pallet with 4 screws. Undo and remove all 4
screws. This reqires an open-ended spanner or socket wrench, size 24 mm (not included
in the scope of supply).

Preparation
Instructions for use • ARTip CRUISE™ • YDZ702_EN_V1.0_03-2021_IFU_CE-MDR 20
14. Then pull the wheel relief board out from under the ARTip CRUISE™ and remove it.
Removing the ARTip CRUISE™ from the pallet
15. Lay the wooden ramp onto the front of the pallet.
16. Unlock the brakes on the wheels of the ARTipCRUISE™.
17. Remove the ARTip CRUISE™ from the pallet via the ramp.
Store the original packaging, since secure transport or shipping of the ARTipCRUISE™
is only guaranteed if the original packaging is used.
5.3 Installing the monitor
The installation of the monitor is performed in 2 steps:
– Attach the cable connections
– Attach the monitor to the monitor holder