IMAGE1 S H3 Camera Heads Instructions for Use Ver 1.0 Jan 2021

01-2021 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.

Table of contents

Table of contents 1 General information... 4 1.1 Read the instructions for use ... 4 1.2 Scope... 4 1.3 Description of warning messages... 4 2 Normal use... 5 2.1 Intended use ... 5 2.2 Indications... 5 2.3 Contraindications... 5 2.4 Target user populations ... 5 2.5 Patient groups... 5 3 Safety ... 6 3.1 Serious incidents ... 6 3.2 Unsterile product ... 6 3.3 Dangers from electrical current... 6 3.4 High light intensity ... 6 3.5 Failure of devices ... 6 4 Product description ... 7 4.1 Product overview ... 7 4.2 Possible combinations... 9 4.3 Technical data... 9 4.4 Symbols employed ... 10 4.4.1 Symbols on the packaging ... 10 4.4.2 Symbols on the product ... 11 4.5 Ambient conditions ... 11 5 Preparation... 12 5.1 Unpacking the product ... 12 5.2 Testing the product... 12 5.3 Assembling the product... 12 5.4 Connecting the light cable ... 12 5.5 Connecting the TH106 microscope camera head ... 13 6 Application ... 15 6.1 Using the product ... 15 6.2 Camera head buttons ... 15 7 Maintenance, servicing, repairs, and disposal... 17 7.1 Repairs to the product ... 17 7.2 Disposing of the product ... 17 8 Accessories and spare parts ... 18 8.1 Accessories... 18 9 Electromagnetic compatibility... 19 9.1 General notes on the operating environment ... 19 9.2 Table 1 – Compliance level for immunity tests ... 19 9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 20 9.4 Table 3 – Test levels for radiated and conducted immunity tests ... 21 9.5 Table 4 – Emission class and group ... 22 9.6 Table 5 – Recommended separation distances between portable and mobile HF communications devices and the product ... 23 10 Subsidiaries... 24

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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General information

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

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

2.

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

3.

Observe the instructions for use of products used in combination.

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

1.2 Scope This instruction manual is valid for: Product

Item no.

IMAGE1 S™ H3-Z

TH100

IMAGE1 S™ H3-ZI

TH101

IMAGE1 S™ H3-P

TH103

IMAGE1 S™ H3-ZA

TH104

IMAGE1 S™ H3-M COVIEW®

TH106

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

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Normal use

2 Normal use 2.1 Intended use In combination with the corresponding camera control unit, light source, monitor, and telescopes or microscopes, camera heads are used to display the endoscopic or open operating field in diagnostic or surgical procedures. Camera heads do not have body contact.

2.2 Indications In combination with appropriate accessories, camera heads can be used to display the endoscopic or open operating field in diagnostic or surgical procedures.

2.3 Contraindications No contraindications relating directly to the medical device are currently known. The responsible physician must decide whether the anticipated application is admissible based on the general condition of the patient.

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

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

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Safety

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

Death of a patient, user, or another person

–

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

–

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

3.2 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.

3.3 Dangers from electrical current An improper power supply may cause an electric shock and injure patients, users, or third parties. Make sure that the plug is completely clean and dry. Never allow HF devices to come into contact with the product or system.

3.4 High light intensity The high level of light intensity produced by the light source may lead to permanent eye damage or blindness, and may cause tissue and items facing the light output to heat up. Do not look into the light output. Set the light source output to a level that is just high enough to ensure optimal illumination of the operating area. Make sure the light output is sufficiently far away from tissue and operating accessories.

3.5 Failure of devices The product may fail during use. Have a replacement product ready for each application or plan for an alternative surgical technique.

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview 1

2

3

4

5

6

TH100 H3-Z 1

Instrument coupler

4

Scroll down / Activate camera function User control button: for scrolling (downwards) through the menu or activating a camera function

2

Focus ring/Focus wheel

5

Scroll up / Select

3

Zoom ring

6

Call up menu / Select

1

2

3

4

5

6

TH101 H3-ZI 1

Instrument coupler

4

Scroll down / Activate camera function

2

Focus ring/Focus wheel

5

Scroll up / Select

3

Zoom ring

6

Call up menu / Select

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Product description

1

2

3

4

5

TH103 H3-P 1

Instrument coupler

4

Scroll up / Select

2

Focus ring/Focus wheel

5

Call up menu / Select

3

Scroll down / Activate camera function

1

2

3

4

5

6

TH 104 H3-ZA 1

Instrument coupler

4

Scroll down / Activate camera function

2

Focus ring/Focus wheel

5

Scroll up / Select

3

Zoom ring

6

Call up menu / Select

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Product description

1

2

3

4

TH106 H3-M COVIEW® 1

C-MOUNT connection

3

2

Scroll down / Activate camera function 4

Scroll up / Select Call up menu / Select

4.2 Possible combinations The product can be combined with the following camera control units (CCU): –

IMAGE1 S CONNECT® (TC200)

–

IMAGE1 S CONNECT® II (TC201)

–

IMAGE1 HD (22 2020 20-1xx)

–

IMAGE1 HUB™ HD (22 2010 20-1xx)

The camera control units (CCU) can be connected to the following LINK module: –

IMAGE1 S™ H3-LINK (TC300)

The products TH100, TH101, TH103, and TH104 can be connected to endoscopes or adaptors via the following connection: –

Eyepiece connection

The product TH106 can be connected to endoscopes or adaptors via the following connection: –

C-MOUNT connection

4.3 Technical data Description

IMAGE1 S™ H3 camera head

Value

Image sensor

3x 1/3" CCD

Image format

16:9

Image refresh rate

50/60 Hz

Applied part type according to IEC 60601-1

CF

Focal length

TH 100 H3-Z

15–31 mm

TH 101 H3-ZI

15.6 mm

TH 103 H3-P

15–31 mm

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Product description

Description

Dimensions (L x H x W)

IMAGE1 S™ H3 camera head

Value

TH 104 H3-ZA

15–32 mm

TH 106 H3-M COVIEW®

Depending on the TV adaptor used

TH 100 H3-Z

100 x 48 x 38 mm

TH 101 H3-ZI TH 103 H3-P

88 x 47 x 38 mm

TH 104 H3-ZA TH 106 H3-M COVIEW Weight (without cable)

100 x 49 x 39 mm ®

45 x 50 x 60 mm

TH 100 H3-Z

270 g

TH 101 H3-ZI

270 g

TH 103 H3-P

227 g

TH 104 H3-ZA

299 g

TH 106 H3-M COVIEW®

240 g

4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Article no.

Serial number

Number of products in the product packaging

Unique Device Identifier

Consult instructions for use

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Product description

Symbol

Meaning Note for the user to consult the instructions for use for important cautionary information such as warnings and precautions. Unsterile

Keep dry

Fragile, handle with care

Federal (USA) law restricts this device to sale by or on the order of a physician. CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body.

4.4.2 Symbols on the product Symbol

Meaning Applied part type CF defibrillation protection. When used in conjunction with a KARL STORZ camera control unit with a CF-defib symbol on the connection port. CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body. Zoom in

Zoom out

4.5 Ambient conditions Storage/transport conditions Temperature

-10 °C ... 60 °C

Relative humidity

20–95%

Operating conditions Temperature

5 °C ... 35 °C

Relative humidity (non-condensing)

20–95%

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Preparation

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.

5.2 Testing the product 1.

Inspect the product for visible contamination. Do not use if contaminated.

2.

Inspect the product for the following characteristics:

–

Good working order

–

Functionality

–

Correct assembly of the components

–

Completeness

5.3 Assembling the product The product has an integrated instrument coupler and an integrated telescope. 1.

Rotate the outer ring of the coupler clockwise and insert the endoscope eyepiece.

2.

If the endoscope is connected to a pendulum camera head, make sure that the pendulum lock is engaged.

3.

Tighten the outer ring on the grasping mechanism.

4.

Rotate the outer ring of the instrument coupler counterclockwise to tighten it.

5.4 Connecting the light cable Tighten the knurled screw on the light cable by a quarter turn to connect the light cable.

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Preparation

5.5 Connecting the TH106 microscope camera head A TV adaptor (e.g., KARL STORZ QUINTUS® TV adaptor) is used to connect the IMAGE1 S™ H3-M COVIEW® microscope camera head to a suitable interface on the surgical microscope. Suitable interfaces are optical beam splitters and co-observer connectors. These options are available for all surgical microscopes.

Some surgical microscopes are equipped with a C-MOUNT connection to which the IMAGE1 S™ H3-M COVIEW® camera head can be directly connected. The IMAGE1 S™ H3-M COVIEW® camera head is delivered with a 9 m cable as standard. KARL STORZ recommends detaching the camera head cable from the camera head in order to make installation easier. 1.

To detach the camera cable, unscrew the cable connector from the camera head by turning in the counterclockwise direction and carefully pull out the cable.

2.

Screw the camera head onto the C-MOUNT connection.

3.

Secure the camera head and TV adaptor to the co-observer interface of the surgical microscope.

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Preparation

4.

Align the tip of the cable plug with the recess provided and press the cable onto the camera head.

5.

Tighten the cable connection by turning clockwise.

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Application

6 Application 6.1 Using the product The image display can be impaired by intense laser light. 1.

Ensure that the correct video image is displayed on the monitor before starting the procedure.

2.

Turn the focus ring/focus wheel to adjust the image sharpness on the camera lens.

3.

Turn the zoom ring to adjust the image size.

6.2 Camera head buttons All camera heads feature three buttons for retrieving programmed functions and for menu control: –

Scroll down: Scrolls down the menus or options.

–

Scroll up: Scrolls up the menus or options.

–

Menu/selection: Display of live menu. Activation of highlighted option.

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Application

1

2

1

Scroll down

2

Scroll up

3

3

Menu/selection

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Maintenance, servicing, repairs, and disposal

7 Maintenance, servicing, repairs, and disposal 7.1 Repairs to the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products.

7.2 Disposing of the product The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment (WEEE). Within the scope of application of this directive, KARL STORZ SE & Co. KG is responsible for the proper disposal of this product. 1.

The product must be disposed of in accordance with the applicable national laws and regulations at a suitable collection point for the reprocessing of electrical and electronic equipment.

2.

Contact KARL STORZ SE & Co. KG, a KARL STORZ branch or an authorized dealer to find out the address of the collection point in your area.

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Accessories and spare parts

8 Accessories and spare parts 8.1 Accessories Not all articles are available in all regions. Article

Order no.

Adaptor, autoclavable

533TVA

Dust cap for camera heads

6349190

Sterile covers for KARL STORZ cameras

040113-01, 040114-01, 040115-01, 040112-01

Extension cable, 5.2 m

22220072

Plastic container for sterilization and storage of IMAGE1 S™ H3-Z (TH100), IMAGE1 S™ H3-ZA (TH104), and IMAGE1 S™ H3‑Z FI (TH102) camera heads, autoclavable

39301Z3TS

H3-M COVIEW® camera head cable, 9 m

22220071

Plastic container for sterilization and storage of IMAGE1 S™ H3-ZI (TH101) and IMAGE1 S™ H3-P (TH103) camera heads

39301PHTS

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Electromagnetic compatibility

9 Electromagnetic compatibility 9.1 General notes on the operating environment The product is suitable for use in professional healthcare settings. Professional healthcare facilities include physician offices, dental offices, limited care facilities, freestanding surgical centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms, patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system for MRT). The emission characteristics of this product make it suitable for use in industrial areas as well as in hospitals (CISPR 11 Class A) and other professional healthcare environments. If it is used in a residential environment (for which CISPR 11 Class B is normally required), the product may not offer sufficient protection for radio transmission operation. The user might need to take mitigation measures, such as relocating or re-orienting the product.

9.2 Table 1 – Compliance level for immunity tests Guidelines and manufacturer’s declaration – electromagnetic immunity The product is intended for use in the electromagnetic environment specified below. The user of the product should make sure that it is used in such an environment. Interference immunity tests

Compliance level

Electromagnetic environment – guidelines

Electrostatic dis- ± 8 kV contact discharge (ESD) acc. charge to IEC 61000-4-2 ± 15 kV air discharge

± 8 kV contact discharge

Floors should be made of wood, concrete, or covered with ceramic tiles. If floors are covered with synthetic material, the relative humidity must be at least 30%.

Electrical fast transients/bursts acc. to IEC 61000-4-4

± 2 kV for power lines

± 2 kV for power lines

± 1 kV for input and output lines

± 1 kV for input and output lines

100 kHz repetition

100 kHz repetition

Surges acc. to IEC 61000-4-5

± 1 kV voltage outer ± 1 kV voltage outer The power supply qualconductor – outer con- conductor – outer con- ity should be that of a ductor ductor typical commercial or hospital environment. ± 2 kV voltage outer ± 2 kV voltage outer

Voltage dips, short interruptions, and voltage variations acc. to IEC 61000-4-11

EN/IEC 60601 test level

± 15 kV air discharge

conductor – ground

conductor – ground

Voltage dip:

Voltage dip:

Dip to 0% for 1 cycle at 0° phase angle

Dip to 0% for 1 cycle at 0° phase angle

The power supply quality should be that of a typical commercial or hospital environment.

The power supply quality should be that of a typical commercial or hospital environment. If Dip to 70% for 25/30 Dip to 70% for 25/30 the user of the product cycles at 0° phase an- cycles at 0° phase an- requires continued opgle gle eration in the event of Dropout to 0% for 0.5 Dropout to 0% for 0.5 interruptions to the cycles @ 0°, 45°, 90°, cycles @ 0°, 45°, 90°, power supply network, 135°, 180°, 225°, 270°, 135°, 180°, 225°, 270°, it is recommended that and 315° phase angles and 315° phase angles the product be oper-

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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Electromagnetic compatibility

Interference immunity tests

EN/IEC 60601 test level

Compliance level

Electromagnetic environment – guidelines

Voltage interruption:

Voltage interruption:

100% for 250/300 cycles

100% for 250/300 cycles

ated with an uninterruptible power supply or a battery.

Magnetic field at 30 A/m at 50 Hz / the power fre60 Hz quency (50/60 Hz) acc. to IEC 61000-4-8

30 A/m at 50 Hz / 60 Hz

If image distortion occurs, it may be necessary to install the product further from sources of electromagnetic fields or to install magnetic shielding. Before the product is installed, the electromagnetic field should be measured to ensure that it is sufficiently low.

Immunity test acc. to IEC 61000-4–3 for radiated, radio-frequency electromagnetic fields

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

Immunity to conducted disturbances, induced by radio-frequency fields acc. to IEC 61000-4-6

3 Vrms on 150 kHz to 80 MHz

3 Vrms on 150 kHz to 80 MHz

1 kHz 80% AM modulation

1 kHz 80% AM modulation

6 Vrms in ISM band

6 Vrms in ISM band

* Refer to Table 2 for wireless proximity RF field test levels

9.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment Test frequency MHz

Frequency band MHz

385

380 – 390

TETRA 400

450

430 – 470

GMRS 460, FRS 460

710

704 – 787

800 – 960

745

Radio service Modulation

Immunity test level V/m

Compliance level V/m

Pulse modulation 18 Hz

27

27

FM ± 5 kHz deviation 1 kHz sine wave

28

28

LTE band 13 & Pulse modula17 tion 217 Hz

9

9

GSM 800/900, Pulse modulaTETRA 800, tion iDEN 820, 18 Hz CDMA 850, LTE band 5

28

28

780 810 870 930

Instructions for use • IMAGE1 S™ H3 Camera Heads • NXA595_EN_V1.0_01-2021_IFU_CE-MDR

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