Storz INSTRUCTION MANUAL User manual

Instructions for use
ENDOMAT SELECT
UP220
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.
06-2021

Table of contents
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 3
Table of contents
1 General information.......................................................................................................................................6
1.1 Read the instructions for use....................................................................................................................6
1.2 Read the instructions for use of compatible products .............................................................................6
1.3 Scope........................................................................................................................................................6
1.4 Description of warning messages.............................................................................................................6
1.5 Abbreviations ............................................................................................................................................7
2 Normal use....................................................................................................................................................8
2.1 Intended purpose......................................................................................................................................8
2.2 Indications.................................................................................................................................................8
2.3 Contraindications......................................................................................................................................8
2.4 Target user populations ............................................................................................................................9
2.5 Patient groups...........................................................................................................................................9
2.6 Intended application areas on the patient ................................................................................................9
2.7 Intended conditions of use .....................................................................................................................10
3 Safety ..........................................................................................................................................................11
3.1 Serious incidents ....................................................................................................................................11
3.2 Correct handling .....................................................................................................................................11
3.3 Unsterile product ....................................................................................................................................11
3.4 Contaminated products ..........................................................................................................................11
3.5 Disposable products...............................................................................................................................11
3.6 Combination with other components .....................................................................................................11
3.7 Damaged products .................................................................................................................................12
3.8 Dangers from electrical current...............................................................................................................12
3.9 Damage due to ingress of liquid in electrical components.....................................................................12
3.10 Electromagnetic interference ..................................................................................................................13
3.11 Failure of products..................................................................................................................................13
3.12 Observing ambient conditions ................................................................................................................13
3.13 Risks in IT networks................................................................................................................................14
3.14 Modifications to the product...................................................................................................................14
4 Product description ....................................................................................................................................15
4.1 Description of operation .........................................................................................................................15
4.2 Product overview ....................................................................................................................................15
4.3 Touchscreen ...........................................................................................................................................17
4.3.1 Symbols on the user interface..................................................................................................... 18
4.4 Possible combinations............................................................................................................................19
4.5 Operating modes ....................................................................................................................................20
4.6 Technical data.........................................................................................................................................20
4.7 Symbols employed .................................................................................................................................22
4.7.1 Symbols on the packaging .......................................................................................................... 22
4.7.2 Symbols on the product .............................................................................................................. 23
4.8 Ambient conditions .................................................................................................................................24
4.9 System description .................................................................................................................................24
4.9.1 Definition...................................................................................................................................... 24
4.9.2 Application area........................................................................................................................... 25
4.9.3 Combination with non-medical products .................................................................................... 25
4.9.4 Multiple socket outlets................................................................................................................. 25
4.9.5 Permissible system load.............................................................................................................. 25
4.9.6 Reprocessing............................................................................................................................... 25
4.9.7 Maintenance ................................................................................................................................ 26
5 Preparation..................................................................................................................................................27
5.1 Unpacking the product ...........................................................................................................................27

Table of contents
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 4
5.2 Product installation .................................................................................................................................27
5.3 Connecting the product ..........................................................................................................................28
5.4 Test the product......................................................................................................................................29
5.5 Putting the product into operation..........................................................................................................30
5.6 Selecting the discipline and procedure ..................................................................................................31
5.7 Installing the tubing set...........................................................................................................................33
5.8 Combined operation with CALCUSON (art. no. 27610020)....................................................................36
5.8.1 Install the bottle holder ................................................................................................................ 37
5.8.2 Putting the CALCUSON into operation ....................................................................................... 39
5.9 Combined operation with UNIDRIVE Select (UM600) ............................................................................40
5.9.1 Putting UNIDRIVE Select into operation...................................................................................... 40
5.10 Combined operation with UNIDRIVE S III (art. no.20701020-1) ............................................................41
5.10.1 Putting UNIDRIVE S III into operation.......................................................................................... 41
5.11 Combined operation with UNIDRIVE S III ARTHRO ...............................................................................42
5.11.1 Putting UNIDRIVE S III ARTHRO into operation .......................................................................... 42
5.12 Connecting the tubing set for indirect suction........................................................................................43
5.13 Connecting the tubing set for direct suction ..........................................................................................45
6 Application ..................................................................................................................................................47
6.1 Menu .......................................................................................................................................................47
6.2 Settings...................................................................................................................................................47
6.2.1 Setting the language.................................................................................................................... 48
6.2.2 Other settings .............................................................................................................................. 48
6.2.3 Setting height difference.............................................................................................................. 49
6.3 Event log .................................................................................................................................................50
6.4 Product information ................................................................................................................................51
6.5 Services ..................................................................................................................................................51
6.6 Venting the tubing system ......................................................................................................................52
6.6.1 SURG........................................................................................................................................... 52
6.6.2 HYS/URO/ART/SPINE ................................................................................................................. 52
6.6.3 Suction......................................................................................................................................... 53
6.7 Using ENDOMAT SELECT as an irrigation pump...................................................................................53
6.7.1 Setting the irrigation flow (SURG/VET SURG) ............................................................................. 54
6.7.2 Set the irrigation flow (ENT/NEURO) ........................................................................................... 54
6.7.3 Set irrigation pressure (HYS/URO/ART/SPINE/VET ART) ........................................................... 55
6.7.4 Starting and stopping the irrigation process ............................................................................... 57
6.8 Using ENDOMAT SELECT as a suction pump .......................................................................................58
6.8.1 Setting the suction flow (IBSShaver / RES / HYS / ART / CALCUSON / VETSURG)................ 59
6.8.2 Starting and ending the suction................................................................................................... 60
7 Maintenance, servicing, repairs, and disposal............................................................................................61
7.1 Maintaining the product..........................................................................................................................61
7.1.1 Maintenance ................................................................................................................................ 61
7.2 Alarm and information signals ................................................................................................................61
7.2.1 Alarm signals ............................................................................................................................... 61
7.2.2 Information signals ...................................................................................................................... 62
7.2.3 Checking the excess pressure alarm .......................................................................................... 64
7.2.4 Checking information signals ...................................................................................................... 64
7.3 Safety inspection in accordance with IEC 62353 ...................................................................................65
7.3.1 Visual inspection.......................................................................................................................... 65
7.3.2 Electric measurements ................................................................................................................ 65
7.3.3 Functional test ............................................................................................................................. 65
7.4 Repairing the product .............................................................................................................................65
7.5 Disposing of the product ........................................................................................................................65
8 Accessories and spare parts ......................................................................................................................67
8.1 Accessories.............................................................................................................................................67
9 Electromagnetic compatibility.....................................................................................................................69

Table of contents
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 5
9.1 General notes on the operating environment .........................................................................................69
9.2 Accessories and lines .............................................................................................................................69
9.3 Table 1 – Compliance level for immunity tests .......................................................................................69
9.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment .......................71
9.5 Table 3 – Test levels for radiated and conducted immunity tests ..........................................................71
9.6 Table 4 – Emission class and group .......................................................................................................73
9.7 Table 5 – Recommended separation distances between portable and mobile HF communications
devices and the product .........................................................................................................................73
10 Faults and messages ..................................................................................................................................75
10.1 Troubleshooting ......................................................................................................................................75
10.2 Software messages ................................................................................................................................75
11 Overview of mitigating warnings.................................................................................................................78
12 Subsidiaries.................................................................................................................................................79

General information
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 6
1 General information
1.1 Read the instructions for use
If the instructions for use are not followed, patients, users, and third parties may be injured or
the product may be damaged.
Read the instructions for use carefully and follow all the safety notes and warnings.
Read the reprocessing instructions carefully and follow all the safety notes and warnings.
The reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering
the item number.
Keep the instructions for use and reprocessing instructions in a safe place.
1.2 Read the instructions for use of compatible products
If the instructions for use of compatible products are not followed, patients, users, and third
parties may be injured or the product may be damaged.
Read the instructions for use of the compatible products carefully and follow all the safety
notes and warnings.
Read the reprocessing instructions of the compatible products carefully and follow all the
safety notes and warnings.
1.3 Scope
This instruction manual is valid for:
Product name Article number
ENDOMAT SELECT UP220
Control cable for combination with UNIDRIVE
S III ARTHRO
UP006
Control cable, length 100cm 20701070
1.4 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.
NOTICE
NOTICE
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

General information
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 7
1.5 Abbreviations
Abbreviation Explanation
ART Arthroscopy
BS Bottle suction
CV Clearvision
CYST Cystoscopy
DS Direct suction
ENT Ear, nose and throat
medicine
ERCP Endoscopic retrograde cholangiopancreatography
FC Flow-controlled
GI Gastrointestinal
GYN Gynecology
HYS Hysteroscopy
IBS Intrauterine BIGATTI Shaver
LAP Laparoscopy
NEURO Neurosurgery
PC Pressure-controlled
PCN Percutaneous nephroscopy
PRO Proctology
RES Resection
SPINE Vertebral column
SURG Surgery
THOR Thoracoscopy
URO Urology
URS Ureterorenoscopy
VET Veterinary medicine

Normal use
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 8
2 Normal use
2.1 Intended purpose
Suction/irrigation pumps
Suction/irrigation pumps and their accessories are used for introducing irrigation fluids into
organs, joints and operating fields as well as for suctioning off irrigation solutions and bodily
fluids, secretions, tissue and gas during diagnostic or therapeutic interventions. Suction/
irrigation pumps and their accessories do not come into contact with the body.
Cable
The connecting cable is used for electrical signal transmission.
2.2 Indications
Suction/irrigation pumps
The product provides irrigation or suction functions for the following disciplines:
– Urology
– Gynecology
– Surgery (thoracoscopy, laparoscopy and proctology)
– Arthroscopy
– Gastroenterology
– Cleaning endoscope lenses
– Spinal surgery
For the product specifications, see chapter Technical data [p.20].
Cable
The connecting cable is used for electrical signal transmission. It does not depend on special
indications.
2.3 Contraindications
Use is contraindicated if, in the opinion of the attending physician, the device is not compatible
with the successful completion of the planned intervention due to its technical design.
The accessories must only be used with the intended devices. In general, medical devices
must not be used on patients who are not part of the defined patient group, or if the operation
itself is contraindicated.
The use of pump systems is contraindicated if, in the opinion of the attending physician, the
surgical method as such is contraindicated, or if the patient is not able to undergo surgery or
anesthesia due to his or her general condition.
Pump systems (pump + associated tubing set) must not come into direct contact with the
central nervous system (CNS) or the central cardiovascular system.
Suction and irrigation modes without pressure monitoring must not be used for the dilatation of
hollow organs or joints.
The device must not be used for the following treatments:
– ERCP
– Cholangioscopy (gastro)

Normal use
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 9
– Spine lumbar (interlaminar access)
– Spine cervical
– Applications that require a non-pulsatile flow
– Administration of medication
– Thorax drainage
– Magnetic resonance tomography
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
This product is intended for the following patient groups:
SURG, URO, ART, SPINE, ENT/NEURO, GI, VET
Patient group Description
Gender No restriction
Age No restriction
Weight >3.5 kg
Nationality No restriction
Medical condition Suitable for endoscopic interventions in the physician's judge-
ment
GYN
Patient group Description
Gender Female
Age No restriction
Weight >3.5 kg
Nationality No restriction
Medical condition Suitable for endoscopic interventions in the physician's judge-
ment
2.6 Intended application areas on the patient
The product can be used on patients in the following areas:
Discipline Application area
SURG Abdomen, thorax, procto
GYN Uterus
URO Lower and upper urinary tract
ART Joints in the foot, knee, hip, shoulder, hand or finger

Normal use
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 10
Discipline Application area
SPINE Thoracic and lumbar vertebral column
ENT/NEURO Cleaning endoscope lenses
GI Upper and lower gastrointestinal tract
2.7 Intended conditions of use
The product may only be used in hospitals and doctors’ offices in suitable ambient conditions.
Condition Operation
Frequency of use One or more times a day
Length of use Several minutes to several hours a day
Place of installation Positioning on a level, vibration-free surface
Mobility Can be moved if placed on a cart.
Combination Can be used on the patient at the same time as other devices.
Control Can be controlled via the KARLSTORZ HIVE.

Safety
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 11
3 Safety
3.1 Serious incidents
A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or
could have any of the following consequences:
– 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.
Check that the product is suitable for the procedure prior to use.
Check the product for the following properties, for example, before and after every use:
– Completeness
– Good working order
– Correct assembly of the components
– Functionality
3.3 Unsterile product
The product is not sterile when delivered. The use of non-sterile products poses a risk of
infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.4 Contaminated products
Contaminated products pose a risk of infection for users, patients, and third parties.
Comply with national laws and regulations.
Observe the guidelines of the Employer’s Liability Insurance Association and equivalent
organizations.
3.5 Disposable products
Disposable products are no longer safe after use. If disposable products are used again, there
is a risk of infection and injury for patients, users, and third parties.
Do not reprocess disposable products.
Dispose of disposable products properly after use.
3.6 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.

Safety
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 12
Only combine the product with devices and components that are approved for joint use by
the manufacturer.
Connect only devices that comply with IEC 60601 to signal inputs and signal outputs.
Comply with national and local regulations.
3.7 Damaged products
Damaged products can result in injury to patients, users, or third parties.
Before each use, check all components of the product for damage.
Do not use damaged products.
3.8 Dangers 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 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.
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.
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.
Connect the product to a power supply with protective conductor.
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 open the product.
Have servicing carried out by KARLSTORZ or a company authorized by KARLSTORZ.
Failure to do so will void the guarantee.
Always pull out the mains plug before carrying out any cleaning and maintenance work.
Do not touch the output jacks of the product and the patient at the same time during use.
During use, explosive anesthetic gases are used. If sparks occur, this may trigger explosions.
Only connect or disconnect the power plug to or from the power supply outside explosive
atmospheres.
3.9 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.

Safety
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 13
3.10 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 MRI, 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.69].
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.
3.11 Failure of products
The product may fail during use.
Have a replacement product ready for each application or plan for an alternative surgical
technique.
3.12 Observing ambient conditions
If the product is used in an unsuitable environment, patients, users, and third parties may be
injured.
Always operate the product in the prescribed ambient conditions, see Chapter Technical
data [p.20].
2. When using explosive narcotic gases: Operate the product outside of the hazard zone.
Do not use the product in the presence of flammable anesthetics.
The product must not be operated in oxygenated environments.

Safety
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 14
3.13 Risks in IT networks
The integration of the product in an IT network can interfere with the function of the product or
other devices in the IT network.
Do not connect the product with an IT network or other devices. Only the KARLSTORZ
Service may use the interfaces for USB and Ethernet.
3.14 Modifications to the product
Modifications to the product reduce the safety of the product, and the user can be injured by
electric shock as a result.
Do not modify the product.

Product description
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 15
4 Product description
4.1 Description of operation
The ENDOMATSELECT is a roller pump that can be used for irrigation and suction of fluids
during operations in various disciplines of human and veterinary medicine. It is not possible to
combine disciplines of human and veterinary medicine.
The device automatically adapts to suit the type of operation being performed by providing the
optimum operating parameters when a tubing set for a specific discipline is attached, provided
the product is enabled for the area of application. The product can be configured in such a way
that only the areas of application that the user wants to use are displayed. Further disciplines
can be retrofitted, and extended setting options are available with the "Advanced Software
Package".
In urological and arthroscopic applications, the irrigation pressure can also be increased briefly
with a BOOST function. In other applications, either the irrigation flow or the irrigation pressure
can be limited.
The product is operated and controlled via a touch screen. The current operating state can be
checked by displaying the set and actual values of the irrigation pressure or flow. If the set
value deviates continuously, an electronic safety circuit blocks the delivery or suction and
acoustic signals sound. An electronic auto-check system tests the various system components
when the product is started and notifies the operator of any failures detected.
The range of functions of the product varies according to the installed software package.
Required accessories for the respective software package are listed in chapter
Accessories and spare parts [p.67].
4.2 Product overview
4
12
3
5
ENDOMATSELECT – Front view
1 Standby button 4 Light barrier
2 TFT touchscreen 5 Pump rollers
3 Pump lever (cartridge locking lever)

Product description
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 16
4
123 5 6
ENDOMATSELECT – Rear view
1 Connection socket Link, e.g., for
Calcuson
4 Connection socket, e.g., for
footswitch
2 USB service interface 5 Potential equalization connector
3 Ethernet interface (KARLSTORZ
HIVE) for service and UNIDRIVE Se-
lect
6 Mains socket
Tubing set for single use

Product description
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 17
4.3 Touchscreen
4
1
2
3
5
6
1 Discipline name 4 Limitation of pressure
2 Start/stop irrigation/suction 5 Limitation of flow
3 Irrigation/suction display 6 Boost pressure increase
Irrigation or suction display
The irrigation or suction function is activated:
– Actual value: orange-colored line
– Set value: white marking
Limitation of pressure or flow
Whether the flow or pressure can be limited depends on the discipline and the installed
Advanced software package.
Boost pressure increase
Boost pressure increase is only available in the disciplines of arthroscopy and urology. The
boost pressure increase can be set with the button or footswitch in 10% steps from 10% –
50%.

Product description
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 18
4.3.1 Symbols on the user interface
Symbol Meaning
Start/stop Irrigation
Standby/pump activated
Start/stop Suction
Standby/pump activated
Start/stop Footswitch
Suction using footswitch
Lock open/closed
Alarm audio
Alarm audio paused (30s)
Back to procedure level
Cancel on procedure level
Confirm on procedure level
Call up menu
Cancel on menu level

Product description
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 19
Symbol Meaning
Confirm on menu level
Back to menu level
Scroll through the menu
Scroll through pages
4.4 Possible combinations
It is recommended that the suitability of the products for the planned procedure be checked
prior to use. Please note that the products listed here may not yet be available in all countries
due to differences in approval requirements.
Products connected to medical electrical devices must comply with local and national
regulations and IEC or ISO standards. Furthermore, all configurations must satisfy the
requirements for medical electrical systems (IEC 60601-1, Section 16, 3rd edition). If additional
devices are connected to electrical medical devices, a medical system is configured that must
satisfy the requirements for medical electrical systems. Local regulations take precedence over
IEC and ISO standards. If you have any questions, please contact your local KARLSTORZ
representative or technical customer support.
The following devices fulfil the requirements of IEC 60601-1, and the product may only be
combined with these devices:
Product name Article number
CALCUSON 27610020
UNIDRIVE Select UM600
UNIDRIVE S III 20701020-1
UNIDRIVE S III ARTHRO 28723020-1

Product description
Instructions for use • ENDOMAT SELECT • UPP220_EN_V1.0_06-2021_IFU_CE-MDD 20
4.5 Operating modes
1
2
Operation as irrigation pump
1 From the irrigant solution bag 2 To the instrument
1
2
Operation as suction pump
1 From instrument/patient 2 To the collection container
4.6 Technical data
Designation Value
Operating voltage (AC) 100–240V
Operating frequency 50/60Hz
Power consumption 82VA
Electrical protection class I
Applied part type according to IEC60601-1 CF