Pediatric Bronchoscopes and Tracheoscopes Instructions for Use

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Copyright © RICHARD WOLF GmbH

Subject to technical changes! Due to ongoing development, the product descriptions, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local representative.

Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

www.richard-wolf.com

2

GA-G117

Contents 1

General information ...

4

1.1

Safety instructions and levels of danger...

4

1.2

Symbols...

5

2

General safety instructions and guidance for use ...

6

3

Product description...

7

3.1

Features of the individual models...

7

4

Intended purpose ...

8

5

Indications ... 10

6

Contraindications and side effects ... 10

6.1

Contraindications... 10

6.2

Side effects... 10

7

Combinations ... 11

7.1

Overview of permissible combinations and requirements ... 11

8

Illustration ... 12

9

Checks... 14

9.1

Visual check ... 14

9.2

Function check ... 14

9.3

Service life ... 15

10

Use ... 15

10.1 10.1.1 10.1.2 10.1.3 10.1.4 10.1.5

Preparation / Commissioning ... 16 Connecting bronchoscope / tracheoscope tubes to the sampling channel – model ... 16 Jet ventilation – model [ A ] [B] [C] [ D ] ... 17 Inserting the proximal lighting insert – model [A] [D] ... 17 Inserting the telescope adapter – model [ A ] [B] [C] [ D ] ... 18 Connecting or removing the light cable – model [ A ] [B] [ D ] ... 18

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5

General notes and instructions for use... 19 Light... 19 Power ... 19 HF application ... 20 Irrigation fluid ... 21 Laser application ... 21

11

Reprocessing and maintenance ... 22

11.1

Reprocessing sequence ... 25

12

Technical description... 30

12.1

Technical data ... 30

12.2

Usage, storage, transport, and shipping conditions ... 30

13

Spare parts ... 31

14

Disposal of product, packaging material and accessories ... 31

GA-G117

3

1

General information

1.1

Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

4

GA-G117

1.2

Symbols

Symbols

Designation Follow the manual Medical device Product number Serial Number Lot code Manufacturer Manufacturing date Number, amount

Data Matrix Code

CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products or EU regulation 2017/745 on medical products. Only valid if the product and/or the packaging is marked with this identification. Products where a notified body is not involved in the conformity assessment procedure are marked with the CE-identification without the code number of the notified body. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal identical products are described, to the Richard Wolf product with the highest classification. The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

GA-G117

5

2

General safety instructions and guidance for use The product must only be used as intended following the instruction manual by adequately trained and qualified medical personnel. Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the products in accordance with the manual before every use and before return shipment to protect the patient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.

6

GA-G117

3

Product description The bronchoscopes / tracheoscopes and pediatric bronchoscopes / tracheoscopes have the following features: 1. Bronchoscope / tracheoscope tubes ð Lateral expiration attachment ð Sealing cap, blue ð Respiration socket ð Receptacle (conical part) for telescope adapter or accessories ð Tube with scale 2. Respiration adapter with Luer connection part (can be used in respiration sockets)

3.1

Features of the individual models [A] Hemer model bronchoscope / tracheoscope 1. Bronchoscope tube ð Sampling channel and Luer sealing cap ð Respiration slits (not present on the tracheoscope tubes) ð Socket for proximal lighting insert ð Sealing plug 2. Proximal lighting insert (can be used in sockets) [B] Wolf model bronchoscopes ¯ Bronchoscope tube ð Respiration slits ð Light outlet ð Integrated light cable ð Cold light connection part [C] Nicolai-Mantel model pediatric bronchoscopes / tracheoscopes ¯ Bronchoscope tube ð Respiration slits (not present on the tracheoscope tubes) ð Handle recess [D] München model pediatric bronchoscopes / tracheoscopes 1. Bronchoscope tube ð Respiration slits (not present on the tracheoscope tubes) ð Socket for proximal lighting insert ð Sealing plug 2. Proximal lighting insert (can be used in sockets)

GA-G117

7

4

Intended purpose Bronchoscope / tracheoscope tubes with sampling channel (Hemer model) 8214.064

BRONCHOSCOPE TUBE ID 6.5 MM

8214.074

BRONCHOSCOPE TUBE ID 7.5 MM

8214.084

BRONCHOSCOPE TUBE ID 8.5 MM

8214.094

BRONCHOSCOPE TUBE ID 9.5 MM

8214.104

BRONCHOSCOPE TUBE ID 10.5 MM

8214.124

TRACHEOSCOPE TUBE ID 12 MM

8214.126

BRONCHOSCOPE TUBE ID 12 MM

8214.128

TRACHEOSCOPE TUBE ID 12 MM

8214.144

TRACHEOSCOPE TUBE ID 14 MM

The products are used to access the operating field, for inserting auxiliary instruments, conducting gases, and removing analysis gas. Bronchoscope / tracheoscope tubes

8

8214.072

BRONCHOSCOPE TUBE ID 7.5 MM

8214.082

BRONCHOSCOPE TUBE ID 8.5 MM

8214.092

BRONCHOSCOPE TUBE ID 9.5 MM

8214.102

BRONCHOSCOPE TUBE ID 10.5 MM

82514.2716

BRONCHOSCOPE TUBE ID 2.8 MM

82510.3016

BRONCHOSCOPE TUBE ID 3.2 MM

82510.3028

BRONCHOSCOPE TUBE ID 3.2 MM

82510.3520

BRONCHOSCOPE TUBE ID 3.7 MM

82514.3520

BRONCHOSCOPE TUBE ID 3.7 MM

82510.3528

BRONCHOSCOPE TUBE ID 3.7 MM

82514.3528

BRONCHOSCOPE TUBE ID 3.7 MM

82510.4025

BRONCHOSCOPE TUBE ID 4.4 MM

82514.4025

BRONCHOSCOPE TUBE ID 4.4 MM

82510.4030

BRONCHOSCOPE TUBE ID 4.4 MM

82514.4030

BRONCHOSCOPE TUBE ID 4.4 MM

82510.4524

TRACHEOSCOPE TUBE ID 4.7 MM

82514.4524

BRONCHOSCOPE TUBE ID 4.7 MM

82510.4525

BRONCHOSCOPE TUBE ID 4.7 MM

82514.4525

BRONCHOSCOPE TUBE ID 4.7 MM

82510.4530

BRONCHOSCOPE TUBE ID 4.7 MM

82514.4530

BRONCHOSCOPE TUBE ID 4.7 MM

82510.5025

BRONCHOSCOPE TUBE ID 5.2 MM

GA-G117

82510.5030

BRONCHOSCOPE TUBE ID 5.2 MM

82514.5030

BRONCHOSCOPE TUBE ID 5.2 MM

82510.5530

BRONCHOSCOPE TUBE ID 5.7 MM

82514.6030

BRONCHOSCOPE TUBE ID 6.2 MM

82510.6035

BRONCHOSCOPE TUBE ID 6.2 MM

82510.6535

BRONCHOSCOPE TUBE ID 6.7 MM

82514.6535

BRONCHOSCOPE TUBE ID 6.7 MM

The products are used to access the operating field and conduct gases. Telescope adapters 8215.711

ADAPTER FOR TELESCOPE TL 98 MM

8215.713

ADAPTER FOR TELESCOPE TL 211 MM

8215.714

ADAPTER FOR TELESCOPE TL 94 MM

8215.715

ADAPTER FOR TELESCOPE TL 124 MM

8215.716

ADAPTER FOR TELESCOPE TL 174 MM

The products are used to fix endoscopes to bronchoscope / tracheoscope tubes. Sealing caps for bronchoscopes / tracheoscopes / esophagoscopes 8205.13

SEALING CAP

8020.15

UNI. SEALING CAP FOR BRONCH.

8021.18

SEALING CAP FOR BRONCH.

8205.12

SEALING CAP

8256.99

SEALING PLUGS TL 25 MM

The products are used for sealing the proximal endoscope outer cone and connection openings. Lighting inserts for bronchoscopes / tracheoscopes / esophagoscopes 8217.12

LIGHTING INSERT

The products are used for connecting endoscope tubes to light sources in order to introduce light into the inside of the body.

User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

GA-G117

9

5

Indications The products are used for therapeutic and diagnostic bronchoscopy in the area of bronchi and the trachea. Patient group The following applies to bronchoscopes / tracheoscopes (8214.xxx): The intended patient group is not limited with regard to ethnicity, age, sex, height, or weight. Before use, the attending physician must make sure that the product in view of its dimensions or settings can be used safely in the patient. The following applies to pediatric bronchoscopes / tracheoscopes (82510.xxx / 82514.xxxx): The use of the products is restricted to patients with small anatomies. There is no restriction regarding ethnicity, gender, or body weight. Before use, the attending physician must make sure that the product in view of its dimensions or settings can be used safely in the patient.

6

Contraindications and side effects

6.1

Contraindications Contraindications directly related to the product are presently unknown. If medical contraindications for the mentioned indications are known, the use of the products is not permitted. On the basis of the patient's general condition the doctor in charge must decide whether or not the planned use is possible.

6.2

Side effects No side effects directly related to the product are known if the product is used as intended.

10

GA-G117

7

Combinations CAUTION Be careful not to combine products incorrectly! Injuries of the user or others as well as damage to the product are possible. n The products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc. are the same. n Also follow the instruction manuals of the products used in conjunction with this product.

7.1

Overview of permissible combinations and requirements The products are used with: ⊳ Light sources and flexible light cables ⊳ Endoscopes ⊳ Respiration systems ⊳ Lasers ⊳ HF surgical devices ⊳ Accessories for endoscopic use; e.g., optical forceps, rigid forceps, electrodes, laser fibers, etc. Models [A] [B] [D] The cold light connection part can be unscrewed and removed to allow the connection of flexible light cables from a different manufacturer, using an appropriate adapter. Ordering information can be found on the relevant catalog pages.

Fig. 1

GA-G117

11

8

Illustration

Fig. 2

12

GA-G117

Item

Designation

Bronchoscope / tracheoscope model

Pediatric bronchoscope / tracheoscope model

Hemer

Wolf

Nicolai-Mantel

München

A

B

C

D

1

Bronchoscope / tracheoscope tubes

●

◦

◦

●

1.1

Lateral expiration attachment

●

●

●

●

1.2

Luer connector (M) – sampling channel

●

◦

◦

◦

1.3

Luer sealing cap

X

◦

◦

◦

1.4

Sampling channel

●

◦

◦

◦

1.5

Scale

●

●

●

●

1.6

Respiration slits (not present on the tracheoscope tubes)

●

●

●

●

1.7

Sealing cap, blue

X

X

X

X

1.8

Socket for proximal lighting insert

●

◦

◦

●

1.9

Conical part

●

●

●

●

1.10

Respiration socket

●

●

●

●

1.11

Designation: Inner tube Ø and total length of the bronchoscope / tracheoscope

●

●

●

●

2

Proximal lighting insert

X

◦

◦

X

2.1

Cold light connection, can be unscrewed

X

X

◦

X

3

Sealing plug

X

◦

◦

X

3.1

O-ring

4

Bronchoscope (with integrated light cable)

◦

◦

4.1

Light outlet

4.2

Lighting attachment

5

Respiration adapter

5.1

Bayonet lock

5.2

O-ring

5.3

Luer connection part

5.4

O-ring

6

◦ ●

X

X

X

X

Telescope adapter

X

X

X

X

7

Bronchoscope tubes (with handle recess)

◦

◦

●

◦

8

Endoscope

X

X

X

X

#

Model no.

●

●

●

●

Symbol legend:

GA-G117

● = applicable ◦ = not applicable X = combinable

13

9

Checks WARNING Injuries by damaged or incomplete products! Injuries of the patient, user and others are possible. n Do not use the products if they are damaged, incomplete or have loose parts. n Run through the checks before and after each use.

ATTENTION Send in damaged or incomplete products together with any loose parts for repair. Repair only by authorized experts.

9.1

Visual check 1. Check the products and accessories for: ð Damage ð Surface changes (e.g., corrosion, cracks) ð Sharp edges not compatible with the intended application ð Loose or missing parts ð Rough surfaces 2. Any inscription, lettering, or labeling necessary for safe use as intended must be legible. 3. Check the respiration adapter (5) for blockages. 4. Check that the respiration slits (1.6) on the bronchoscope (A), (B), (C), (D) are clean.

9.2

Function check 1. 2. 3. 4. 5.

Light quality; remove any soiling on light inlet and light outlet surfaces. Check that the lighting insert (2) engages. Check that the accessories are securely fitted to the conical part. Check the respiration system. Check locking and tight fit of the respiration adapter (5) in the respiration socket (1.10). O-rings (5.2), (5.4) must be fitted. 6. Check the continuity of the respiration adapter (5). 7. Check that the Luer connection part (5.3) is securely fitted in the respiration adapter (5). 8. Check that the individual connections are compatible and fitted securely. 9. Check the entire system for leaks and continuity. 10. Check the irrigation and suction function.

14

GA-G117

9.3

Service life ATTENTION For the service life of the products, careful and gentle handling during use and during the entire reprocessing process is essential When used as intended and following the instructions in the manufacturer's instructions for use, it is not necessary to limit the service life of the medical products. If one or several criteria of the described checks are not passed, the medical product must be replaced or returned for repair (by the OEM or a repair facility authorized by the OEM) if necessary.

10

Use WARNING The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before and after use, check the products for damage, loose parts and completeness. Make sure that no missing instrument parts remain in the patient. n Do not use products which are damaged or incomplete or have loose parts.

Respiration with closed systems

WARNING Insufficient patient respiration! If not all openings on the bronchoscope / tracheoscope tube are closed when ventilating with a closed system, for example, the patient's respiration will be insufficient and the operating room staff may be put at risk. Close all openings on the bronchoscope / tracheoscope tube.

Jet ventilation

WARNING Insufficient patient respiration! If all openings are closed during jet ventilation, expiration by the patient will not be possible. Open the lateral expiration attachment if the proximal tube end is closed.

GA-G117

15

Tracheoscopes

WARNING Insufficient patient respiration! Tracheoscope tubes do not have lateral distal openings. Risk of insufficient respiration if not used as intended.

WARNING The product should only be used and brought to the surgical site under visual control and, if necessary, under X-ray control.

10.1

Preparation / Commissioning The following preparation measures must be carried out for each bronchoscope / tracheoscope model: 1. Check assembly: Section 11.1 Reprocessing sequence. 2. Perform checks: Section 9 Checks. 3. Tighten the cold light connection part (2.1).

10.1.1

Connecting bronchoscope / tracheoscope tubes to the sampling channel – model 1. Connect the connecting tube to the M Luer connection and the monitoring device. 2. Check the sampling channel for damage and blockages.

16

GA-G117

10.1.2

Jet ventilation – model [ A ] [B] [C] [ D ] Observe the following when working with jet ventilation: ⊳ Only use the respiration adapter (5). ⊳ Only to be carried out by specially trained personnel. ⊳ Use suitable monitoring. Connecting the respiration adapter to a jet ventilator with a Luer connection part 1. Tightly screw the Luer connection part to the respiration adapter. ð AIR = Marking on the Luer connection part; only for applications with air 2. Connect the jet respiration device's connection tube to the Luer connection part.

Fig. 3

ATTENTION Only use the Luer connection part for jet ventilation. 3. Install the respiration adapter. ð The nose inside the respiration socket engages in the groove of the respiration adapter. 4. Lock the respiration adapter: Turn in the direction of the arrow. ð Align the markings on the respiration socket and on the respiration adapter. 5. Remove the Luer connection part and the respiration adapter: Turn in the opposite direction to the arrow.

10.1.3

Inserting the proximal lighting insert – model [A] [D] NOTE Ensure that the proximal lighting insert does not fall down during insertion, adjustment, or removal, and become damaged as a result.

1. Illuminate the bronchoscope / tracheoscope tube: Push the lighting insert in as far as latch point (a). 2. Do not illuminate the bronchoscope / tracheoscope tube: Pull back the lighting insert from latch point (a) to (b). 3. Remove the lighting insert: Pull the lighting insert out of the socket and insert the sealing plug.

Fig. 4

GA-G117

17

10.1.4

Inserting the telescope adapter – model [ A ] [B] [C] [ D ] 1. Attach the appropriate telescope adapter to the conical part. 2. Introduce the endoscope: The clamping handle is in position "I". ð The nose (c) engages in the groove (d). 3. Turn the clamping handle to position "II". ð The endoscope is locked.

Fig. 5

10.1.5

Connecting or removing the light cable – model [ A ] [B] [ D ]

Fig. 6

NOTE In order to achieve optimum light output, we recommend using a flexible light cable from Richard Wolf. The appropriate fiber bundle diameter for the endoscope can be selected based on the model number of the flexible light cable. The codes for the fiber bundle diameter on the cold light connection part must correspond to the two digits after the point.

1. Connect the light cable: Plug into the cold light connection part and connect to a suitable light source. ð The light cable engages. 2. Remove the light cable: Press the button.

Fig. 7

18

GA-G117

10.2

General notes and instructions for use WARNING The products have only limited strength! Applying excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. n Do not use the products if they are damaged, incomplete or have loose parts.

10.2.1

Light WARNING Intense heat due to high light energy! Danger of inadvertent tissue damage - due to insufficient distance between the light exit area and the tissue - due to soiling of the light exit area n Do not touch the light exit area and avoid direct contact with the tissue. n Remove any soiling.

WARNING Risk of injury due to fire! The high heat generation at the area where light is emitted can lead to excessive heating or ignition when the endoscope is put down on heat-sensitive, flammable surfaces (dark cloths, etc.). ⊳ Place the endoscope in a safe place.

10.2.2

Power WARNING Danger of electric shock! Patient leakage currents can add up if the endoscopes are combined with other energetically operated endoscopic accessories. n Make sure that the combinations do not exceed the permissible patient leakage currents.

ATTENTION Use only products with type BF applied parts in conjunction with the endoscope.

GA-G117

19

10.2.3

HF application Observe the "Notes on HF application", order no. GA-S002 and those of the HF device manufacturer.

NOTE In the case of HF applications, interferences may occur in the endoscopic image. This is a normal occurence and does not indicate any malfunction.

CAUTION Thermal tissue injuries due to damaged insulation! On frequently reprocessed and on aged HF instruments the insulation can be damaged. A damaged insulation causes leakage currents leading to thermal tissue injuries of the patient, user or others. n Check the insulation for damage before use. n Do not use HF instruments once the insulation is damaged.

Fig. 8

CAUTION Risk of HF arcing! Too small a distance between parts conducting high-frequency current and other conductive parts can lead to unintentional damage to the tissue and the instrument. When HF power is activated, parts of HF instruments conducting high-frequency current must have a safety distance of at least 10 mm from the distal end of the endoscope. In the event of HF arcing, replace the electrode immediately, check the endoscope for damage, and send it in for repairs if necessary to prevent subsequent damage.

CAUTION Incorrect selection of the HF output power! Injuries to the patient as well as damage to the product are possible. The power setting must be adjusted in accordance with the operator's experience/training with reference to the applicable indication.

20

GA-G117