IFU Battery Light Sources Instructions For Use

11-2020 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 for use... 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 Correct handling ... 6 3.3 Correct reprocessing ... 6 3.4 Contaminated products ... 6 3.5 Unsterile product ... 6 3.6 Damaged products ... 7 3.7 Failure of systems ... 7 3.8 Combination with other components ... 7 3.9 Risk of explosion... 7 4 Product description ... 8 4.1 Product overview ... 8 4.2 Possible combinations... 8 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 6 Application ... 14 6.1 Using the product ... 14 6.2 Activating and deactivating BOOST mode ... 14 6.3 Charging the battery (11301DE, 11301DF) ... 15 7 Maintenance, servicing, repairs, and disposal... 16 7.1 Maintenance ... 16 7.2 Changing the batteries... 16 7.3 Repairing the product ... 17 7.4 Disposing of the product ... 17 8 Electromagnetic compatibility... 18 8.1 General notes on the operating environment ... 18 8.2 Table 1 – Compliance level for immunity tests ... 18 8.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ... 19 8.4 Table 3 – Test levels for radiated and conducted immunity tests ... 20 8.5 Table 4 – Emission class and group ... 21 8.6 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product ... 22 9 Subsidiaries... 23

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_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 These instructions for use are valid for the following products: Product

Item number

LED battery light source

11301D1 11301D3

LED battery light source, rechargeable

11301DE 11301DF

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 • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Normal use

2 Normal use 2.1 Intended use Battery light sources are used as a mobile light source for intubation endoscopes that do not contain an internal light source. Battery light sources are designed for transient or short-term use in invasive procedures through a body orifice.

2.2 Indications for use The use of intubation endoscopes is indicated if, in the opinion of the responsible physician, a fiberoptic endotracheal intubation or inspection of the oropharyngeal, supraglottic, or subglottic region is indicated or PCT is performed. This includes, amongst other things: –

Endotracheal intubation with a difficult respiratory tract

–

Endoscopic inspection and monitoring of the mouth, nose, and throat region

–

Monitoring of percutaneous tracheostomy

–

Anesthesiological bronchoscopy

–

Bronchial lavage

2.3 Contraindications The use of the intubation endoscope is contraindicated if, in the opinion of the responsible physician, the surgical method is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition. Intubation endoscopes must not be used for interventions in direct contact with the central nervous system (CNS) and central cardiovascular system. No other contraindications are known.

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.

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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 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. Do not overload the product with mechanical stress. 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

3.3 Correct reprocessing Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection. Reprocess the product before use. A validated reprocessing procedure must be followed and the product must be reprocessed in line with the reprocessing instructions.

3.4 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 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.

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Safety

3.6 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the products for damage. Do not use damaged instruments.

3.7 Failure of systems The system may fail during use. Have a replacement system ready for each application.

3.8 Combination with other components Combination of the product with non-suitable 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. Only use approved accessories.

3.9 Risk of explosion The product can generate sparks, which cause combustible or flammable gases and liquids to ignite or explode. This may cause injuries to patients, users, or third parties. The product must not be operated in oxygenated environments. Do not operate the product in explosive atmospheres. Do not operate the product in environments with combustible gases such as inhalation anesthetics and mixtures thereof. Observe the hazard zones:

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview 4

3

8

7

1 5 6

2 Battery light sources 11301D1, 11301D3 1

Light outlet

5

Lid lock

2

Switch (On/Off)

6

Lid

3

Screw connection on endoscope/fiberscope

7

Marker pin: Locked

4

Housing

8

Batteries 2 x 3 V / CR123A

3

4

1

2

5

6

Battery light sources 11301DE, 11301DF 1

Light outlet

4

Housing

2

Switch (On/Off)

5

Serial port for charging the battery

3

Screw connection on endoscope/fiberscope

6

Fixing button for click connection to endoscope/fiberscope

4.2 Possible combinations The battery light sources can be used with the following components: –

Batteries for 11301D1, 11301D3: – Panasonic CR123A with UL Recognized Component Mark (UR) – Duracell DL123A with UL Recognized Component Mark (UR)

–

Charging units for 11301DE, 11301DF: – Charging unit (11301DG)

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Product description

– Battery charger (094129) – Power cord (094127) –

Endoscopes/fiberscopes: – All KARL STORZ rigid telescopes

4.3 Technical data Battery light sources (11301D1, 11301D3) Characteristic

Value

Dimensions (L x H x W)

95 x 40 x 20 mm

Weight

80 g (without battery)

Color temperature

6,000–6,700°K

Drip-water protection

None, wipeable, disinfectable

Protection class

Internal voltage supply

Power supply (DC)

3V

Battery

2 x CR123A 3 V lithium

Battery light sources (11301DE, 11301DF) Characteristic

Value

Dimensions (L x H x W)

95 x 40 x 20 mm

Weight

Approx. 110 g

Color temperature

6,000–6,700°K

Drip-water protection

None, wipeable, disinfectable

Protection class

Internal voltage supply

Power supply (DC)

Max. 4.2 V

Battery

Li-ion polymer battery, 3.7 V (DC) / 900 mAh / 3.3 Wh

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Product description

4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol

Meaning Number of products in the product packaging

Article no.

Batch code

Medical device

US Federal law (21 CFR 801.109) restricts this device to sale to or on the order of a licensed physician

Manufacturer

Date of manufacture

Unique Device Identifier

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. Fragile, handle with care

Not MR safe

Keep dry

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Product description

4.4.2 Symbols on the product Symbol

Meaning Follow instructions for use

Heat emission

Applied part type BF

Article no.

Batch code

Separate collection of electrical and electronic devices. Do not dispose of in household refuse. 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. Observe the correct battery polarity Power supply

4.5 Ambient conditions Storage/transport conditions Temperature

-20°C ... +60°C

Relative humidity

10–90%

Air pressure

700–1,080 hPa

Operating conditions Temperature

10°C ... 30°C

Relative humidity

30–70%

Air pressure

700–1,080 hPa

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_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 Use a suitable adaptor to screw the product onto the endoscope/fiberscope light inlet: –

11301D1: No adaptor

–

11301D3: Adaptor (495G)

–

11301DE: Adaptor (495F)

–

11301DF: Adaptor (495G)

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Preparation

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Application

6 Application 6.1 Using the product WARNING High energy! Risk of injury! The light source transmits high-energy light that can lead to high surface temperatures. The user or a third party may be startled if they come into contact with the hot light source and then injure the patient by jerking the endoscope/fiberscope. Do not touch the hot light source. Only use the light source with an endoscope/fiberscope. Always switch off the light source before putting it down, and never place it in the vicinity of the patient. WARNING High energy! Risk of fire! The light source transmits high-energy light that can lead to high surface temperatures. Do not cover the light source with cloths or similar objects immediately after use. WARNING High light intensity! Danger of glare! The high light intensity of the light source can permanently damage eyes and cause blindness. Never look directly into the light outlet of the light source. 1.

Use the switch (On/Off) to switch the product on.

2.

Use the switch (On/Off) to switch the product off after use.

The LED flashes several times to signal the end of the battery service life. The flashing repeats at 2-minute intervals until the battery is completely discharged after 5–10 minutes: Model

Service life

11301D1/D3

2h

11301DE/DF

40 minutes

Comment –

2 batteries

–

Rechargeable batteries must not be used.

1,000 charges

6.2 Activating and deactivating BOOST mode The brightness can be increased in BOOST mode. ü

The product is switched on.

1.

To activate BOOST mode, press and hold the switch (On/Off). ð The brightness is increased.

2.

To deactivate BOOST mode, press and hold the switch (On/Off) once again. BOOST mode is then automatically deactivated after a certain amount of time.

ð The nominal brightness is reset.

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Application

6.3 Charging the battery (11301DE, 11301DF) WARNING Rechargeable battery! Risk of injury! Do not touch the patient and the battery charger plug at the same time. Recharge the battery outside the patient environment. ATTENTION Incorrect handling! Damage to the product! Disposable batteries should never be charged in a battery charger. 1.

Charge the battery using the battery charger (094129) or the charging unit (11301DG). See the instructions for use for the lithium-ion battery charger (96056016).

094129

11301DG

ð The charging process takes approx. 1 hour. 2.

After charging, check that the product is functioning properly.

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Maintenance, servicing, repairs, and disposal

7 Maintenance, servicing, repairs, and disposal 7.1 Maintenance Maintenance work may only be carried out by KARL STORZ or a company authorized by KARL STORZ. Interval

Maintenance work

To be performed by

2 times a year

Replace battery

KARL STORZ service technicians

7.2 Changing the batteries 1.

Place your thumb on the lid lock.

2.

Turn the lock counterclockwise and remove the lid.

3.

Remove the old batteries and insert two new batteries. Both batteries must always be replaced at the same time.

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Maintenance, servicing, repairs, and disposal

4.

Replace the lid and turn the lock clockwise as far as it will go.

5.

Check that the battery light source is functioning properly and then switch it off.

7.3 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. 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.

7.4 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 • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Electromagnetic compatibility

8 Electromagnetic compatibility 8.1 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 professional healthcare facilities as well as in a residential environment (CISPR 11 Class B). This product offers adequate protection to radio communication service. In the rare event of interference to the radio transmission operation, the user might need to take mitigation measures, such as relocating or re-orienting the product.

8.2 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

EN/IEC 60601 test level

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

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

± 2 kV for power lines

N/A

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

Surges acc. to IEC 61000-4-5

± 1 kV voltage outer N/A conductor – outer conductor

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

± 15 kV air discharge

± 1 kV for input and output lines 100 kHz repetition

± 2 kV voltage outer conductor – ground Voltage dips, short interruptions, and voltage variations acc. to IEC 61000-4-11

Voltage dip:

N/A

Dip to 0% for 1 cycle at 0° phase angle Dip to 70% for 25/30 cycles at 0° phase angle Dip to 0% for 0.5 cycles @ 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315° phase angles

The power supply quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation in the event of interruptions to the power supply network, it is recommended that the product be oper-

Voltage interruption:

Instructions for use • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Electromagnetic compatibility

Interference immunity tests

EN/IEC 60601 test level

Compliance level

100% for 250/300 cycles

Electromagnetic environment – Guidelines ated with an uninterruptible power supply or a battery.

Magnetic field at power frequency (50/60 Hz) acc. to IEC 61000-4-8

30 A/m at 50 Hz /60 Hz

30 A/m at 50 Hz /60 Hz

Immunity test acc. to IEC 61000-4–3 for high-frequency electromagnetic fields

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

Immunity to conducted interference, induced by high-frequency fields acc. to IEC 61000-4-6

3 Vrms on 150 kHz to 80 MHz

If image distortion occurs, it may be necessary to install the product further away 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.

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

1 kHz 80% AM modulation 6 Vrms in ISM band

8.3 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 • Battery Light Sources • KCC913_EN_V1.0_11-2020_IFU_CE-MDR

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Electromagnetic compatibility

Test frequency MHz

Frequency band MHz

Radio service Modulation

Immunity test level V/m

Compliance level V/m

1,700 – 1,990

GSM 1800, Pulse modulaCDMA 1900, tion GSM 1900, 217 Hz DECT, LTE band 1, 3, 4, 25, UMTS

28

28

2,450

2,400 – 2,570

Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE band 7

Pulse modulation 217 Hz

28

28

5,240

5,100 – 5,800

WLAN 802.11 a/n

Pulse modulation 217 Hz

9

9

1,720 1,845 1,970

5,500 5,785

8.4 Table 3 – Test levels for radiated and conducted 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

EN/IEC 60601 test level

Compliance level

Conducted HF disturbances acc. to IEC 61000-4-6

3 Vrms

3 Vrms

Radiated HF disturbances acc. to IEC 61000-4-3

3 V/m

150 kHz to 80 MHz 3 V/m

80 MHz to 2.5 GHz

Electromagnetic environment – guidelines Portable and mobile HF communications equipment should be used no closer to any part of the product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distances: d = 1.2 √P Where P is the rated power of the transmitter in watts [W] according to the information provided by the transmitter manufacturer and d is the recommended separation distance in meters [m].

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