Storz E-BOX Manuel utilisateur
Instructions for use
E-BOX
TP012
en
Copyright ©
All product illustrations, product descriptions, and texts are the intellectual property of
KARLSTORZSE&Co.KG.
Their use and reproduction by third parties require the express approval of
KARLSTORZSE&Co.KG.
All rights reserved.
03-2021
Table of contents
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................4
1.1 Read the instructions for use.................................................................................................................... 4
1.2 Read the instructions for use of combinable products............................................................................. 4
1.3 Scope........................................................................................................................................................4
1.4 Initial commissioning ................................................................................................................................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 population.....................................................................................................................................5
3 Safety ............................................................................................................................................................6
3.1 Serious incidents ......................................................................................................................................6
3.2 Unsterile product ......................................................................................................................................6
3.3 Damaged products ...................................................................................................................................6
4 Product description ......................................................................................................................................7
4.1 Product overview ......................................................................................................................................7
4.2 Possible combinations..............................................................................................................................7
4.3 Technical data...........................................................................................................................................8
4.4 Ambient conditions ...................................................................................................................................8
4.5 Symbols on the packaging ....................................................................................................................... 9
5 Preparation..................................................................................................................................................10
5.1 Unpacking the product ...........................................................................................................................10
5.2 Testing the product.................................................................................................................................10
5.3 Connecting the product ..........................................................................................................................10
6 Disassembly................................................................................................................................................12
6.1 Disassembling the product ..................................................................................................................... 12
7 Maintenance, servicing, repairs, and disposal............................................................................................13
7.1 Repairing the product .............................................................................................................................13
7.2 Safety inspection in accordance with IEC 62353 ................................................................................... 13
7.3 Disposing of the product ........................................................................................................................13
8 Electromagnetic compatibility.....................................................................................................................14
8.1 General notes on the operating environment .........................................................................................14
8.2 Table 1 – Compliance level for immunity tests ....................................................................................... 14
8.3 Table 2 – Test levels for proximity fields from HF wireless communications equipment ....................... 16
8.4 Table 3 – Test levels for radiated and conducted immunity tests .......................................................... 17
8.5 Table 4 – Emission class and group .......................................................................................................18
8.6 Table 5 – Recommended separation distances between portable and mobile HF communications
equipment and the product ....................................................................................................................18
9 Subsidiaries.................................................................................................................................................20
General information
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 4
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 the following products:
E-BOX TP012
1.4 Initial commissioning
This product must be reprocessed before being used for the first time.
Normal use
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 5
2 Normal use
2.1 Intended use
The E-BOX is used for processing and transferring data from an endoscope to KARL STORZ
camera control units. The E-BOX has no direct contact with the human body.
2.2 Indications
The indication is defined by the device that is controlled using the additional operating
elements or for which the additional accessories are used.
2.3 Contraindications
The contraindication is defined by the device that is controlled using the additional operating
elements.
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 population
There are no restrictions in terms of patient groups for this product.
Safety
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 6
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 Damaged products
Damaged products can result in injury to patients, users, or third parties.
Before each use, check all components of the product for damage.
Do not use damaged products.
Product description
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 7
4 Product description
4.1 Product overview
4
1
2
3
5
6
1 Flexible single-use videoendoscope
2 E-BOX
3 Socket for flexible single-use videoendoscope
4 Indicator light
5 C-MAC monitor
6 Connecting cable for CCU
4.2 Possible combinations
The E-BOX TP012 is only suitable for use with the following KARL STORZ products:
Instruments Camera control units
E-BOX
TP012
KARL STORZ single-use videoen-
doscopes 091xxx
C-MAC® monitor 8403ZX (from soft-
ware version 704v302)
C-HUB® II 20290320 (from software
version 1.06)
Product description
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 8
4.3 Technical data
E-BOX TP012
Housing length 175mm
Cable length 200mm
Width 30mm
Depth 24mm
Weight Approx. 93g
Classification Class 1
Input voltage 5V
Power input 950mW
LED status display Green: ready for use
4.4 Ambient conditions
NOTICE
Damage due to ingress of liquid!
Liquid ingress into the product can cause a short-circuit which would damage the product.
Do not store any liquids on, above, or close to the product.
Do not spray the product directly during disinfection.
In the event of ingress of liquid into the product, switch off the product, disconnect it
from the power supply, and allow it to dry completely.
Storage and transport
Ambient temperature - 10° ... + 60°C
Relative humidity 5% ... 95%
Atmospheric pressure 700 ... 1080hPa
Application
Ambient temperature 0° ... 40°C
Relative humidity 30% ... 70%
Atmospheric pressure 700 ... 1080hPa
Product description
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 9
4.5 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Number of products in the product packaging
Unsterile
Temperature limit
Humidity limit
Air pressure limit
Keep dry
Consult instructions for use
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 prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
Preparation
Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR 10
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
Check that the product is functioning properly and is in good working order.
5.3 Connecting the product
NOTICE
Risk of product damage due to unsuitable accessories!
Using the plug-in adapter for the C-MAC® 8401XA in combination with the E-BOX can cause
damage to the product or the connected instrument.
Do not use the E-BOX in combination with the plug-in adapter for the C-MAC® 8401XA.
1. Connect the connecting cable for the flexible single-use videoendoscope to the E-BOX
for X-LINK socket.
2. Connect the connecting cable for the E-BOX for X-LINK to the corresponding port on the
camera control unit (CCU).
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