Olympus A00010A User manual

INSTRUCTIONS FOR USE
HF CABLE
A00010A
A00011A
A00012A
A0335.1
A0355
A0357
A0358
A0391
A0392
A0393
A60000C
A60001C
A60002C
A60003C
O0120.1
WA00013A
WA00014A

Contents
1 Using this document...............................................................5
1.1 User instructions ................................................................. 5
1.2 Conventions throughout this document............................... 5
1.3 Safety-related information in this document........................ 6
1.4 Trademarks ......................................................................... 7
2 Safety information................................................................... 8
2.1 Intended purpose ................................................................ 8
2.2 Contact................................................................................ 9
2.3 General safety notes ......................................................... 10
3 Product description .............................................................. 12
3.1 Scope of delivery .............................................................. 12
3.2 Product functions .............................................................. 12
3.3 Operating elements........................................................... 12
3.4 Symbols ............................................................................ 21
3.5 Warranty............................................................................ 22
4 Before use..............................................................................23
4.1 Inspection.......................................................................... 23
4.2 Attaching the neutral electrode ......................................... 24
4.3 Connecting the HF cable (not for WA00014A).................. 25
4.4 Connecting the HF cable (only for WA00014A) ................ 25
5 Use.......................................................................................... 28
5.1 Safety notes for use .......................................................... 28
5.2 Using the product.............................................................. 30
6 After use ................................................................................ 32
6.1 Disassembly...................................................................... 32
6.2 Preparation for reprocessing at the point of use ............... 32
7 General information for reprocessing................................. 33
7.1 Overview of the reprocessing cycle .................................. 33
7.2 Validated reprocessing methods....................................... 36

8 Cleaning and disinfection .................................................... 39
8.1 Safety notes for cleaning and disinfection......................... 39
8.2 Manual cleaning................................................................ 40
8.3 Manual disinfection ........................................................... 42
8.4 Automated cleaning and thermal disinfection ................... 43
8.5 Inspection.......................................................................... 46
9 Sterilization............................................................................ 48
9.1 Safety notes for sterilization .............................................. 48
9.2 Steam sterilization............................................................. 48
10 Repair, shipment and disposal .......................................... 51
10.1 Repair ............................................................................. 51
10.2 Shipment......................................................................... 51
10.3 Disposal .......................................................................... 52
11 Ordering information .......................................................... 53
12 Compatible equipment ....................................................... 54
13 Technical data ..................................................................... 67
13.1 Dimensions ..................................................................... 67
13.2 Specications.................................................................. 68
13.3 Ambient conditions.......................................................... 68
14 Glossary............................................................................... 69
15 Index..................................................................................... 72

5
Using this document
1 Using this document
This chapter provides a general information on how to use these
instructions for use.
1.1 User instructions
Before use, thoroughly read these instructions for use and the
instructions for use of all other products that will be used during
the procedure.
If the required instructions for use are missing, immediately
contact an Olympus representative.
Keep the instructions for use in a safe, accessible location.
1.2 Conventions throughout this document
Convention Explanation
This is the safety alert symbol. It is used to alert the user to
potential physical injury hazards. Observe all safety messages
that follow this symbol to avoid possible injury.
This symbol indicates additional helpful information.
1.
2.
3.
A numeration indicates a sequence of actions.
●Bullet points indicate individual actions.
–
–
–
Dashes indicate the listing of data, options or objects.
1)
2)
3)
Numbers with right parenthesis name elements in illustrations.

6
Using this document
1.3 Safety-related information in this document
For safe and efcient use of this product it is important to read
the complete instructions for use. The safety related information
of these instructions for use is not only described in this chapter.
All information and instructions in this document are to ensure a
safe and efcient use.
Safety information are described in 3 categories:
– General safety notes
– Specic safety notes
– Safety messages
1.3.1 General safety notes
General safety notes are located at the beginning of the
instructions for use. They address safety issues that apply to the
general use and handling of the product.
1.3.2 Specic safety notes
Specic safety notes are located at the beginning of a chapter
or section. They address safety issues that are specic to the
information and actions described in the chapter or section.
1.3.3 Safety messages
Safety messages focus on unexpected incidents that can occur
during the intended use. They are placed in the context of such
risks and actions. The safety messages are highlighted by a
signal word.
WARNING
Indicates a potentially hazardous situation which, if not avoided,
can result in death or serious injury.

7
Using this document
CAUTION
Indicates a potentially hazardous situation which, if not avoided,
can result in minor or moderate injury.
NOTICE
Indicates a property damage message.
1.4 Trademarks
– STERRAD®
– NX™
– V-PRO®
are trademarks of their respective owner.

8
Safety information
2 Safety information
This chapter provides general safety information for using the
product. The safety information includes:
– Intended purpose
– Manufacturer information
– General safety notes
2.1 Intended purpose
2.1.1 Intended use and indications
A00010A, A00011A, A00012A, A0335.1, A0355, A0357,
A0358, A0391, A0392, A0393, A60000C, A60001C, A60002C,
A60003C, O0120.1, WA00013A, WA00014A
HF cables for electrosurgical use in laparoscopic, endoscopic,
and open surgery in combination with compatible active
accessories and compatible electrosurgical generators.
2.1.2 Contraindications
There are no known contraindications.
The intended use and contraindications of the equipment used in
combination with the HF cable or adapter must be observed.
2.1.3 Patient target group
Not dedicated to any specic patient population.
2.1.4 Intended user
Medical use
Only for use by a qualied physician or medical personnel under
the supervision of a physician.

9
Safety information
Only for use in an adequate medical environment.
These instructions for use do not explain or discuss clinical
procedures.
Reprocessing
Reprocessing of reusable products may only be performed by
qualied hygiene personnel.
2.1.5 Clinical benets
The device is used as part of a system. The clinical benet of
the device lies in its functionality as described by its intended
purpose.
2.2 Contact
2.2.1 Manufacturer
Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany
Country-specic information
Refer to the contact information for customers included in the
scope of delivery for country-specic information.
2.2.2 Incident reporting
European Union
If a serious incident occurs with the device, report it to the
manufacturer and the relevant national authority.

10
Safety information
Eurasian Economic Union
If an undesirable event occurs with the device, report it to the
manufacturer or the authorized representative.
Other regions
If a serious incident occurs with the device, report it to the
manufacturer and/or the relevant national authority according to
national legislation.
2.3 General safety notes
The following safety information addresses points that apply to
the general handling and use of the product. This information is
to be supplemented by the information given in each chapter of
this document.
Repair and product modications
Unauthorized repairs and product modication can cause injury
to the patient and the user. Repairs may only be performed
by qualied servicing personnel that has been authorized by
Olympus. Refer to the section “Repair” on page 51 for more
details.
Spare equipment
Malfunctions of the product can delay the procedure. To avoid
any delays, always have spare equipment available.
WARNING
Risk of injury to the patient and the user
An insufcient understanding of the dangers, warnings, cautions,
and instructions can result in serious injury and damage to the
product.
●Make sure to have the complete set of instructions for use.
●Before use, thoroughly read these instructions for use and
the instructions for use of all other products that will be used
during the procedure.
● In case of conicting information, follow the dangers,
warnings, cautions, and instructions in this document.

11
Safety information
WARNING
Risk of injury to the patient and the user
The use of damaged equipment, equipment that does not
function properly and equipment with illegible or missing
markings can cause infection, toxic shock, electrical, mechanical
and thermal injury and unintended nerve stimulation.
●Before each use, observe the instructions in the section
“Inspection” on page 23.
●Do not use a damaged product or a product with improper
functioning.
●Replace a damaged product or a product with improper
functioning.
WARNING
Risk of injury to the patient
Improperly assembled equipment can cause infection, electrical,
mechanical and thermal injury and unintended nerve stimulation.
●Observe the assembly instructions in these instructions for
use and the instructions for use of all other products that will
be used during the procedure.
CAUTION
Risk of injury to the patient and the user
Using incompatible equipment can lead to injury of the patient
and the user as well as damage to the product.
●For information on compatible equipment, refer to the chapter
“Compatible equipment” on page 54.

12
Product description
3 Product description
This chapter provides a general overview of the product and its
functions. This includes the following information:
– Scope of delivery
– Product functions
– Operating elements
– Explanation of symbols
– Warranty information
The product is delivered in unsterile condition. Reprocess the
product before rst and each subsequent use.
3.1 Scope of delivery
Before use, check that all items listed below are available.
Contact an Olympus representative or an authorized service
center if any items are missing or damaged.
Contents
– 1 HF cable
– Instructions for use
– Contact information for customers
3.2 Product functions
The HF cable connects the electrosurgical generator to the
instrument or HF-resection electrode for the application of HF
current during laparoscopic, endoscopic procedures and open
surgery.
3.3 Operating elements
This section shows all operating elements of the product and
gives a brief description of the purpose of these elements.

13
Product description
A00010A
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
A00011A
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator

14
Product description
A00012A
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
A0335.1
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator

15
Product description
A0355
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
A0357
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator

16
Product description
A0358
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
A0391
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator

17
Product description
A0392
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
A0393
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator

18
Product description
A60000C
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
A60001C
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator

19
Product description
A60002C
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
A60003C
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator

20
Product description
O0120.1
1) Plug (female)
For instrument
2) Plug (male)
For electrosurgical generator
WA00013A
1) Right angle plug
For working element
2) Straight plug
For working element
3) Plug (male)
For electrosurgical generator