Storz DRILLCUT-X II User manual

Instructions for use
DRILLCUT-X II/DRILLCUT-X II-35
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.
03-2020

Table of contents
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................5
1.1 Read the instructions for use.................................................................................................................... 5
1.2 Read the instructions for use of combinable products............................................................................. 5
1.3 Scope........................................................................................................................................................5
1.4 Description of warning messages.............................................................................................................5
2 Normal use....................................................................................................................................................6
2.1 Intended purpose......................................................................................................................................6
2.2 Indications.................................................................................................................................................6
2.3 Contraindications......................................................................................................................................6
2.4 Complications and other undesired side effects ......................................................................................6
2.5 Intended application areas .......................................................................................................................6
2.6 Target user populations ............................................................................................................................ 6
2.7 Patient population.....................................................................................................................................7
3 Safety ............................................................................................................................................................8
3.1 Serious incidents ......................................................................................................................................8
3.2 Warnings ...................................................................................................................................................8
4 Product description ....................................................................................................................................11
4.1 Product overview 40712050 ...................................................................................................................11
4.2 Product overview for applied parts 40712050........................................................................................11
4.3 Product overview 40712035 ...................................................................................................................13
4.4 Product overview for applied parts 40712035........................................................................................13
4.5 Symbols on the packaging .....................................................................................................................15
4.6 Included with delivery .............................................................................................................................16
4.7 Possible combinations............................................................................................................................16
4.8 Technical data.........................................................................................................................................17
4.9 Storage and usage conditions ................................................................................................................17
5 Preparation..................................................................................................................................................19
5.1 Unpacking the product ...........................................................................................................................19
5.2 Assembling the handle (optional)............................................................................................................19
5.3 Connecting the suction and irrigation tubes...........................................................................................20
5.4 Assembling the reusable shaver attachments ........................................................................................20
5.5 Assembling the single-use shaver attachments .....................................................................................22
5.6 Assembling the single-use sinus burr..................................................................................................... 23
6 Operation ....................................................................................................................................................25
6.1 Basic information on operation...............................................................................................................25
7 Disassembly................................................................................................................................................26
7.1 Disassembling the product ..................................................................................................................... 26
7.2 Removing the handle from the handpiece (optional) .............................................................................. 26
8 Maintenance, servicing, repairs, and disposal............................................................................................28
8.1 Servicing and repair ................................................................................................................................ 28
8.2 Repairing the product .............................................................................................................................28
8.3 Disposing of the product ........................................................................................................................28
9 Accessories and spare parts ......................................................................................................................29
9.1 Recommended accessories (not included with delivery)........................................................................29
10 Fault correction ...........................................................................................................................................30
10.1 Troubleshooting ......................................................................................................................................30
11 Electromagnetic compatibility.....................................................................................................................31
11.1 General notes on the operating environment ......................................................................................... 31
11.2 General notes on the operating environment ......................................................................................... 31
11.3 Table 1 – Compliance level for immunity tests .......................................................................................31

Table of contents
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 4
11.4 Table 2 – Test levels for proximity fields from HF wireless communications equipment ....................... 33
11.5 Table 3 – Test levels for radiated and conducted immunity tests ..........................................................34
11.6 Table 4 – Emission class and group .......................................................................................................35
11.7 Table 5 – Recommended separation distances between portable and mobile HF communications
equipment and the product ....................................................................................................................35
12 Subsidiaries.................................................................................................................................................37

General information
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 5
1 General information
1.1 Read the instructions for use
If the instructions for use are not followed, patients, users, 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.
Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products
If the instructions for use of combinable 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 combinable products carefully and follow all the safety
notes and warnings.
1.3 Scope
These instructions for use are valid for:
Product name Item number
DRILLCUT-X II-35 shaver handpiece 40712035
DRILLCUT-X II shaver handpiece 40712050
Handle, adjustable 40712090
Cleaning adaptor 41250RA
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
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Normal use
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 6
2 Normal use
2.1 Intended purpose
Shaver handpiece for DRILLCUTX II AND DRILLCUTX II-35
The shaver handpiece is used to accommodate and drive rotating and oscillating instruments
by mechanically transmitting and converting the speed and torque as well as the rotational
direction for shaver and burr applications. The shaver handpiece is non-invasive and is
designed for transient use in surgically invasive interventions.
Universal handle 40 7120 90
The handle can be fixed on the corresponding handpiece to allow better handling of the
instrument. The handle is designed for transient use in surgically invasive interventions.
2.2 Indications
The ENT motor system accessory is indicated if use of rotary and oscillating instruments is
indicated in the opinion of the attending physician. This includes the following indications,
among others:
– Minimally invasive interventions in ENT surgery and plastic procedures for controlled
excision, morcellation, removal, ablation, and transection of bone/tissue
– Ablation of solid adenoidal masses
– Rhinoplasty
– Resection of soft and bone tissue
2.3 Contraindications
Use of the ENT motor system accessory is contraindicated if, in the opinion of the attending
physician, the device and accessory instruments are not compatible with successful
completion of the planned intervention due to their technical design or the patient is not able to
undergo surgery or anesthesia due to his or her general condition. ENT motor system
accessories must not be used for interventions in direct contact with the central nervous
system (CNS) and central cardiovascular system.
2.4 Complications and other undesired side effects
– Bleeding
– Infections
– Injury to surrounding tissue and bones
– Burns
– Transection or injury to nerves
– Undesirable ablation of tissue
2.5 Intended application areas
The product can be used universally in the ENT, NEURO, and SPINE fields of application.
2.6 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.

Normal use
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 7
2.7 Patient population
There are no restrictions in terms of patient groups for this product.

Safety
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_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 Warnings
WARNING
Read the following safety notes carefully before using the product to avoid endangering
your patients, your personnel, or yourself
WARNING
Risk of infection: These instruments are not sterile when delivered. The use of unsterile
instruments poses a risk of infection for patients, users, and third parties. Inspect
instruments for visible contamination. Visible contamination is an indication that
reprocessing has not been carried out, or has been carried out incorrectly. Reprocess
the instruments before initial use and before and after every subsequent use using
validated procedures.
WARNING
Before using the system, the user must ensure that the individual system components
are functioning correctly and reliably, and are in full working order. Always check the
device before any surgical procedure to ensure that it is working properly. This must be
done at the earliest possible time before starting the surgical procedure on the patient.
WARNING
Risk of injury: Incorrect application of medical instruments poses a risk of injury for
patients. Users of medical instruments must have an appropriate medical qualification
and be acquainted with the application.
WARNING
Risk of injury: Incorrectly assembled and damaged instruments can lead to injuries to the
patient. Instruments and all of the accessories used in combination with them must be
checked immediately before and after every use to ensure that they are complete, free
from damage, and in full working order and have no unintentional rough surfaces, sharp
corners, burred edges, or projecting parts. Care must be taken not to leave missing or
broken-off components inside the patient.
WARNING
Risk of injury for the patient: The sheaths and tips of the blades/burrs must not have any
grooves, scratches, or dents. After cleaning, inspect the handpieces, blades, and burrs
for cleanliness and damage.

Safety
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 9
WARNING
Check the packaging for damage and to ensure the expiration date has not passed. If the
expiration date has passed or if the packaging is damaged, dispose of the instruments.
WARNING
Both sheaths must have the same article number. If the sheaths are assembled
incorrectly, this can generate excessive heat and wear at the tip of the shaver
attachments.
WARNING
If the rotating wheel is not secured to the handle, the patient can be injured by
uncontrolled rotations of the shaver attachment.
WARNING
The UNIDRIVE® S is only designed for intermittent operation (combined with the devices
to be used) (50%, t = 1 min).
WARNING
Risk of burns. A system that is not operated intermittently when working with the motor
or handpiece can increase the instrument, handpiece, and motor temperature.
WARNING
Risk of burns: A lack of suction and irrigation when working with the DRILLCUT-X® II
can result in increased temperature of the handpiece. Always work with suction and
irrigation.
WARNING
When using rotating instruments, ensure that the instruments are sufficiently irrigated
and cooled. Inadequate irrigation can result in contaminated or blocked instruments, or
cause jerky movements. This can generate excessive heat and endanger the user or
patient.
WARNING
The use of an unsuitable operating mode may damage the sinus burr. Only operate the
DRILLCUT-X® II-35 in 35k operating mode with the 35k sinus burrs with red connector
specified for this purpose. Only operate the DRILLCUT-X®II-35 with other (12k) sinus
burrs in 12k operating mode.
WARNING
Only operate the handpiece when the applied parts are visible.
WARNING
The use of this device next to or with other devices should be avoided, as this can result
in incorrect operation. If such use is necessary, this and the other devices should be
observed to ensure that they are operating correctly.
WARNING
Portable HF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30cm (12inches) to any part of the
device, including cables specified by the manufacturer. Otherwise, performance may be
impaired.

Safety
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 10
WARNING
Always keep a spare device at hand in case the first device fails.
WARNING
Do not open the device! Arrange for service work to be carried out by the manufacturer
or by personnel authorized by the manufacturer only. Any opening of the device by non-
authorized personnel will void the warranty.

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 11
4 Product description
4.1 Product overview 40712050
2
1
4
11
356
7
8
9
10
12
1 DRILLCUT-X II handpiece 7 Connector
2 Lock (blade mount) 8 Handle
3 Guide grooves for the handle 9 Rotating wheel
4 Irrigation port 10 Connectors for guide grooves
5 Suction device 11 Clamping jaw
6 Integrated connecting cable 12 Cleaning adaptor
4.2 Product overview for applied parts 40712050
Reusable shaver attachments (applied parts)
straight

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 12
curved 35°/40°
curved 65°
Single-use shaver attachments (applied parts)
straight
curved 35°/40°
curved 65°
Single-use sinus burr (applied parts)
curved 35°/40°

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 13
4.3 Product overview 40712035
4
1
2356
7
8
9
10
11
12
1 DRILLCUT-X II-35 handpiece 7 Connector
2 Lock (blade mount) 8 Handle
3 Guide grooves for the handle 9 Rotating wheel
4 Irrigation port 10 Connectors for guide grooves
5 Suction device 11 Clamping jaw
6 Integrated connecting cable 12 Cleaning adaptor
4.4 Product overview for applied parts 40712035
Single-use sinus burr (applied parts)
curved 15°
curved 40°

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 14
curved 40°
curved 40°
curved 70°
Reusable shaver attachments (applied parts)
straight
curved 35°/40°
curved 65°
Single-use shaver attachments (applied parts)
straight
curved 35°/40°
curved 65°

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 15
4.5 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Unique Device Identifier
Consult instructions for use
Keep dry
Do not use if package is damaged.
Temperature limit
Humidity limit
Air pressure limit
Article no.
Serial number
Number of products in the product packaging
Medical device
Unsterile
Type BF device

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 16
Symbol Meaning
Separate collection of electrical and electronic devices.
Do not dispose of in household refuse.
In accordance with US federal law (21 CFR 801.109), this product may
only be sold to or on prescription from a licensed physician.
CE marking
With this mark, the manufacturer declares the compliance of the devices
with the applicable standards and directives
The device must not be modified in any way
4.6 Included with delivery
– DRILLCUT-X II shaver handpiece, model 40712050 with integrated connecting cable
– Cleaning adaptor 41250RA
or
– DRILLCUT-X II-35 shaver handpiece, model 40712035 with integrated connecting cable
– Cleaning adaptor 41250RA
Optional accessories
Handle, adjustable, model 40712090, for use with all DRILLCUT-X II shaver handpieces
Required accessories
The DRILLCUTX II/DRILLCUTX II-35 shaver handpiece requires additional accessories for
normal use:
– Motor control unit
– Shaver attachments
– Sinus burr
For compatible accessories, see the chapter on possible combinations.
4.7 Possible combinations
UNIDRIVE
SIII ECO
40701401
UNIDRIVE
SIII ENT
40701601-1
UNIDRIVE
SIII NEURO
40701701-1
Sterilizable
shaver/burr
attach-
ments
Single-use
shaver/
burr
attach-
ments
Handle
40712090
DRILLCUT-
X II
• • • •* •* •
DRILLCUT-
X II-35
• • •* •* •
* For a detailed list of compatible shaver attachments and sinus burrs, please refer to our
ENDOSCOPES AND INSTRUMENTS FOR ENT and NEUROSURGERY catalogs.

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 17
4.8 Technical data
Power input 150 – 200 VA
Operating temperature 10 – 30°C
Operating mode Intermittent duty
Duty cycle 50%; t = 1 min
Weight with cable 371 g
Max. dimensions (W × H × D) 140 × 34 × 13 mm
Average life cycle 200 reprocessing cycles
Shaver rotation speed (DRILLCUT-X II)
Minimum speed 300rpm
Maximum speed 10,000rpm
Start-up maximum speed 4000rpm
Rotation mode Oscillation
Shaver rotation speed (DRILLCUT-X II-35)
Minimum speed 900rpm
Maximum speed 10,000rpm
Start-up maximum speed 4000rpm
Rotation mode Oscillation
Sinus burr 12k rotation speed (DRILLCUT-X II)
Minimum speed 300rpm
Maximum speed 12,000rpm
Start-up maximum speed 12,000rpm
Rotation mode Rotation
Sinus burr 35k rotation speed (DRILLCUT-X II-35)
Minimum speed 1,500rpm
Maximum speed 35,000rpm
Start-up maximum speed 35,000rpm
Rotation mode Rotation
4.9 Storage and usage conditions
NOTICE
Improper storage may damage the product.
The described storage and usage conditions must be complied with.

Product description
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 18
Storage/transport conditions
Temperature -20°C to 60°C
Relative humidity
(non-condensing)
20% to 95%
Air pressure 500 hPa–1,080 hPa
Usage conditions
Temperature 10°C to 30°C
Relative humidity
(non-condensing)
30% to 70%
Air pressure 500 hPa–1,080 hPa

Preparation
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 19
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 Assembling the handle (optional)
NOTICE
Turning the rotating wheel clockwise when the handle is disassembled can damage the
seal.
Do not turn the rotating wheel clockwise while the handle is disassembled.
Depending on the application and desired holding position, the handpiece can either be used
without the handle or with the optional handle.
The handle can be aligned to point either to the front...
...or to the back.
Before assembling ensure that the clamping jaw does not project beyond the guide channel.
1. Insert the handle with the guide in the guide grooves of the DRILLCUTXII/DRILLCUTX
II-35 shaver handpiece and push it into the desired position.

Preparation
Instructions for use • DRILLCUT-X II/DRILLCUT-X II-35 • WWK497_EN_V1.0_03-2020_IFU_CE-MDR 20
2. Fix the handle in place by turning the rotating wheel clockwise as far as it will go.
3. Check that the handpiece is securely fixed in place before use.
5.3 Connecting the suction and irrigation tubes
Prerequisite: The suction and irrigation tubes must be connected to the respective suction/
irrigation pump. Observe the instructions for use for the device used.
1. Connect the irrigation tube to the shaver handpiece’s irrigation port.
2. Connect the suction tube to the shaver handpiece’s suction port.
5.4 Assembling the reusable shaver attachments
WARNING
Both sheaths must have the same article number. If the sheaths are assembled
incorrectly, this can generate excessive heat and wear at the tip of the shaver
attachments.