Instruction Manual

INSUFFLATOR Highflow 45
2235

GA-A 274 / en / 2012-12 V1.0 / PDG 00-0000

 Important general notes and instructions
Make sure that this product is used only as intended and described in this instruction manual, by adequately trained
and qualified medical personnel, and that maintenance and repair are only 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 applic­
ation and if the performance characteristics and safety requirements are not impaired. Do not alter the product in any
way.
Reprocess the products before every application and before returning them for repairs as required by the instruction
manual in order to protect the patient, user and others.
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.
Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the
shipment give right to complaints, please inform the manufacturer or supplier immediately.
Subject to technical changes!
Due to ongoing developments, the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger

Symbols Level of danger
WARNING!
Failure to observe can result in death or serious injury.
CAUTION!
Failure to observe can result in slight injury or damage to the product.
IMPORTANT!
. Failure to observe can result in damage to the product or surroundings.
NOTE!
. Tips for optimum use and other useful information.

GERMANY USA UK
RICHARD WOLF GmbH RICHARD WOLF RICHARD WOLF UK Ltd.
75438 Knittlingen Medical Instruments Corporation Waterside Way
Pforzheimerstr. 32 353 Corporate Woods Parkway Wimbledon
Telephone: +49 70 43 35-0 Vernon Hills, Illinois 60061 SW17 0HB
Telefax: +49 70 43 35-300 Toll Free: 001 (800) 323 - 9653 Telephone: + 44 20 89 44 74 47
MANUFACTURER Phone: 001 (847) 913 - 1113 Telefax: + 44 20 89 44 13 11
[email protected] Fax: 001 (847) 913 - 1488 [email protected]
www.richard-wolf.com [email protected] www.richardwolf.uk.com
www.richardwolfusa.com
BELGIUM / NETHERLANDS FRANCE AUSTRIA
N.V. Endoscopie RICHARD WOLF France S.A.R.L. RICHARD WOLF Austria
RICHARD WOLF Belgium S.A. Rue Daniel Berger Ges.m.b.H.
Industriezone Drongen Z.A.C. La Neuvillette Wilhelminenstraße 93 a
Landegemstraat 6 F-51100 Reims A-1160 Vienna
9031 Gent Drongen Telephone: +33 3 26 87 02 89 Telephone: +43 14 05 51 51
Telephone: +32 92 80 81 00 Telefax: +33 3 26 87 60 33 Telefax: +43 14 05 51 51 45
Telefax: +32 92 82 92 16 [email protected] [email protected]
[email protected] www.richard-wolf.com
www.richard-wolf.be

Marketing Office INDIA

U.A.E RICHARD WOLF India Private Ltd.
RICHARD WOLF Middle East JMD Pacific Square
P.O. Box 500283 No. 211 A, Second Floor
AL Thuraya Tower 1 Behind 32nd Milestone
9th Floor, Gurgaon - 122 001
Room 904, Dubai National Capitol Region
Telephone: + 9 71 43 68 19 20 Telephone: + 91 12 44 31 57 00
Telefax: + 9 71 43 68 61 12 Telefax: + 91 12 44 31 57 05
[email protected] [email protected]
www.richard-wolf.com www.richard-wolf.com

GA-A 274 0
 Contents
1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4 Contraindications and side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4.1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4.2 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5.1 Instruments for INSUFFLATOR Highflow 45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5.2 Potential equalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5.3 Requirements for products / components of a combination . . . . . . . . . . . . . . . . . . . . . . . 7
1.6 Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.7 Connection diagram - in dialog mode (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2 Illustration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1 Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2 Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1 Language settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2 CO2 connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.1 Preparation for CO2 operation with gas bottle/cylinder . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.2 Preparation for CO2 operation using centralized gas supply . . . . . . . . . . . . . . . . . . . . . . 15
3.3 Connecting the insufflation tube set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.3.1 Reprocessable insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3.2 Disposable insufflations tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.4 Highflow insufflation tubes with heating wire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.4.1 Reprocessable highflow insufflation tube with heating wire . . . . . . . . . . . . . . . . . . . . . . . 17
3.4.2 Disposable highflow insufflation tube with heating wire . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.4.3 Disposable tube set for smoke gas evacuation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.1 Visual check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.2 Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.2.1 Device function after switching on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.2.2 Checking the gas supply (status message) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.2.3 Manual checks of the control function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.2.4 Checking the pressure and flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.1 Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2 Controls and modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2.1 Operation and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2.2 Dispaly of remaining CO2 gas supply in the status display . . . . . . . . . . . . . . . . . . . . . . . 22
5.2.3 Gas consumption in status display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2.4 Indicator for gas heating (only 2235021, 2235031 / 2235621, 2235631) . . . . . . . . . . . . 23
5.2.5 Footswitch for smoke gas evacuation (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.2.6 Video on-screen display with dialog function (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.3 Control sequence and menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

GA-A 274 I
5.3.1 Overview - control sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.3.2 Overview - menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.4 Menu levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.5 Menu control and touchscreen functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.6 Selection of main level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.7 Selection of device modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.8 Selection of Richard Wolf profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.8.1 Changing the standard profiles (default profiles) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.9 Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.10 Device parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.10.1 Adjusting the device parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.11 Display of actual and nominal values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.11.1 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.11.2 General service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.12 Operation of INSUFFLATOR Highflow 45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.12.1 Important note for using the reprocessable highflow insufflation tube with heating wire 34
5.12.2 Notes and instruction for using smoke gas evacuation . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.12.3 Creating a pneumoperitoneum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.12.4 Highflow device mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.12.5 Measures after carrying out insufflation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.12.6 Possible alarms during the application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.12.7 Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.12.8 Taking out of service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.13 Overview of operator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.13.1 Structure of operator messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.13.2 Message types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.13.3 Functionality of control elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.13.4 Operator's messages (green) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.13.5 LOW error (turqoise) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.13.6 MEDIUM error (yellow) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.13.7 HIGH error (red) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

6 Operation within the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

6.1 Functional principle within the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.2 Combining and controlling the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.3 Setting the system ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.4 Connection to the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

7 Reprocessing and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

7.1 Reprocessing of device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.2 Reprocessing of reusable insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.2.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.2.2 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.3 Reprocessing of reusable highflow insufflation tube with heating wire . . . . . . . . . . . . . . 44
7.4 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.4.1 Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5 Quarterly check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.1 Measuring and test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.2 Checking the pressure and flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

II GA-A 274
 Contents
7.5.3 Leakage test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

8 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
8.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
8.1.1 Fault in the core system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
8.2 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
8.2.1 Application parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
8.2.2 Pressure and flow values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
8.2.3 Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
8.2.4 Optional device variants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.3 Operating, storage, transport and shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.4 Spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
8.5 Replacing parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
8.5.1 Device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
8.5.2 Disposal of product, packaging material and accessories . . . . . . . . . . . . . . . . . . . . . . . . 51

GA-A 274 III

1 General information

1.1 Symbols
Symbols Designation

Attention, Caution

Follow the instruction manual

OFF (no power supply, separation from mains)

ON (connection to the mains / line voltage)

Potential equalization

Power / Mains fuse

μ Alternating current (AC)

TYPE CF APPLIED PART

Hygiene filter

Gas heating

Alarm

Signal sound

Signal sound switched off

Footswitch

Input connector for smoke gas evacuation / data input

Output connector for insufflation / data output

Recycle the product separately. Do not discard together with other waste.

REF Order number

Lot designation

Manufacturer

Manufacturing date

Quantity

Use-by date

1 GA-A 274
 Symbols Designation

Do not reuse.

Latex-free

Contains phthalates or phthalates are present: Diethylhexyl phthalate (DEHP)

-25_C
+ 50_C
Maximum temperature range for shipment, transport and storage

Sterilized with ethylen oxide

Steam sterilization - fractional method

XX°
Permissible temperature range
XX°
XXhPa
Permissible atmospheric pressure range
XXhPa
XX%
Permissible humidity range
XX%

Do not use mobile phone / radio intercom

A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard
of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (us)

Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or
packaging is marked with this symbol. Products of category IIa and above, as well as sterile products
or products with measuring function of category I, are additionally identified with the code no. of the
notified body (0124).

1.2 Intended use

The INSUFFLATOR Highflow 45 (2235) serves to create and maintain a
pneumoperitoneum using CO2 gas. It can be used for both diagnostic and
surgical laparoscopy.
In conjunction with integrated smoke gas evacuation (2235011/2235031)
and the "Continuous Flow" (2235104) software module, the system also
serves to distend the colon (rectal cavity and lower portion of the sigmoid)
in a pressure-controlled manner for the purpose of Transanal Endoscopic
Microsurgery (TEM).

This product is designed exclusively for use by specialized medical per­

sonnel and may only be applied by medically qualified and adequately
trained doctors.

GA-A 274 2
1.3 Indications and field of use
The INSUFFLATOR Highflow 45 (2235) is primarily used in diagnostic
and surgical laparoscopy but can also be used for TEM using the integ­
rated smoke gas evacuation (2235011/2235031) and the "Continuous
Flow" (2235104) software module. For TEM applications please follow
the latest instruction manual for the TEM system.
On the basis of the patient’s general condition, the user in charge must
decide whether the planned use is possible or not. For further notes and
instructions please refer to the latest medical literature.

CAUTION!
In case of therapeutic applications an adequate backup device with the
same capabilities must be available should the device fail.
CAUTION!
It is not allowed to use mobile phones or similar devices while the INSUF­
FLATOR Highflow 45 is used.

. NOTE!
We recommend reading relevant literature for the planned application.

1.4 Contraindications and side effects

1.4.1 Contraindications
The use of this device is contraindicated whenever laparoscopy is con­
traindicated.
WARNING!
The device has a highflow rate.
The device is not suitable for hysteroscopy.
This device must not be used for distending the cavum uteri.
Contraindications resulting from the patient's general condition and de­
scribed in the relevant literature must be observed.

This device is contraindicated in the case of hysteroscopic insufflation -

do not use this device for intrauterine distension.

Absolute contraindications:
D Hypovolemic shock represents an absolute contraindication with the
exception of laparoscopic surgeons who have adequate experience in
procedures for blood extraction from the abdomen and for finding and
stopping a hemorrhage site and can execute them safely and so can
achieve hemostasis quicker than by laparotomy.
D In the case of severe inflation of the intestine during intestinal obstruc­
tion, increased possibility of adhesions in the pelvis and in the abdomen
as well as in the case of an elevated diaphragm, the required insuf­
flation is contraindicated and the space available for a visualization is
severely limited and the probability of injuring the intestine is severely
increased.
D A further contraindication is the existence of a large mass in the pelvis
or in the area of the pelvis and abdomen (which in general extends to
the umbilicus or above). There is an increased risk of injuring this mass,
and there is a high probability that endoscopic visualization is poor and
that the extension and the nature of the mass cannot be determined. A
mass of this size would probably have to be removed by a laparotomy.

3 GA-A 274
 D A type 4 cardiac decompensation also represents a contraindication as
the insufflation and its positioning could cause irreversible arrhythmia to
the heart which is filled with congested blood and cause cardiac failure.

Relative contraindications:
D Septic peritonitis
D Pelvic abscess
D Multiple interventions in the abdomen
D Diaphragmatic hernia
D Obesity
D Pregnancy

TEM is contraindicated where a general contraindication against surgical

interventions, a severe infection or severe metabolic disorders exist.
On the basis of the patient's general condition the doctor in charge must
decide whether the planned use is possible or not. For further notes and
instructions please refer to the latest medical literature.

GA-A 274 4
1.4.2 Side effects
Warnings:
Metabolic acidosis and the resulting cardiac arrhythmia. Intraabdominal
pressures of more than 20 mmHg (mercury column) for an extended
period of time must be avoided.
This may lead to the following complications:
D Reduced breathing with impaired diaphragm excursion
D Reduced venous backflow
D Reduced cardiac output
D Acidosis
Excessive absorption of CO2 is either due to excessive flow or excessive
pressure. The abdomen can be sufficiently distended with pressures
between 15 - 20 mmHg (mercury column). Hardly ever abdominal pres­
sures of more than 20 mmHg are required. At these values only limited
absorption should occur. Pressures of more than 20 mmHg (mercury
column) are actually never necessary and will lead to increased and
faster absorption. Adequate artificial respiration will help to avoid prob­
lems with regard to CO2.
Z Idiosyncratic reactions. In patients suffering from sickle-cell disease or
pulmonary insufficience the use of these devices can lead to an in­
creased risk of a metabolic imbalance due to excessive CO2 absorp­
tion.
Z Hypothermia. Highflow rates bear the potential risk of hypothermia.
Precautions:
It is strongly recommended using a hydrophobic bacteria filter to prevent
the transmission of microorganisms between patients.

5 GA-A 274
1.5 Combinations
. IMPORTANT!
In addition to this instruction manual, follow the manuals for the products
used in combination with this product.
WARNING!
Danger of life-threatening gas or air embolism.
Purge the connection tubes/hoses with a sufficient amount of CO2 before
use.
The use of devices using additional gaseous media in combination with
the INSUFFLATOR Highflow 45 is exclusively within the responsibility of
the user.
WARNING!
Danger of intrabdominal excess pressure when using a second gas
source.
When using argon plasma coagulators an additional visual or manual
pressure monitoring device of the user is mandatory because the
pressure monitoring function / pressure relief of the INSUFFLATOR High­
flow 45 can be inactive as a result of a kinked insufflation tube or a closed
instrument stopcock.
The preselected gas flow rates of the argon plasma coagulator should not
exceed 2 l/min. Activate the argon plasma coagulator only briefly.

1.5.1 Instruments for INSUFFLATOR Highflow 45

The INSUFFLATOR Highflow 45 can be combined with the instruments
used during a diagnostic and/or surgical laparoscopy and/or TEM.
Follow the instruction manuals of the products used in conjunction with
this product.
On principle, the INSUFFLATOR Highflow 45 can be combined with all
trocar sleeves available in the market.

GA-A 274 6
1.5.2 Potential equalization
The potential equalization cable establishes a direct connection between a medical electrical de­
vice and an equipotential bonding rail.
It serves to equalize differences in potential between enclosures of electrical equipment and firmly
installed conductive parts in the patient environment.

1.5.3 Requirements for products / components of a combination

1.5m
1.5m
1.5m The general requirements depend on whether the products /
components are inside or outside the patient environment.

IEC 60601-1, 3. Ed.

Medically used room Non-medically Requirements / measures

used room
inside the outside the Leakage currents to section 16.6
patient environment patient environment IEC 60601-1:2005 / EN 60601-1:2006 *

MP MP
- - Verification of the total patient leakage current
~ ~
MP MP

~ **

MP NMP
**
~ ~
MP NMP
- Verification of leakage currents
a) additional protective earth connection
**
~ - (consult the corresponding manufacturer),

MP or
NMP b) additional isolating transformer for medical applications **

~
MP NMP

~
MP MP / NMP

**
~

MP NMP Verification of leakage currents

- a) no plugs with metal housing, or
~ ~ b) additional isolation device (to avoid voltage differentials)

Verification of leakage currents

a) common protective earth connection, or
MP MP / NMP b) additional protective earth connection at MP (clarify with the corre­
ponding manufacturer), or
~ ~ c) additional isolation device (to avoid voltage differentials), or
d) no plugs with metal housing in the patient environment

additional "isolating transformer" to IEC/ EN60601-1 additional isolating device to IEC/

Multiple socket strip
** EN 60601-1
Functional connection ~ Power supply grid
MP = medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 08
NMP = non-medical electrical device in accordance with product-specific IEC/EN/UL standards
* When connected via a multiple socket strip under standard conditions the earth leakage current of the power bar must not exceed 5 mA.
** e.g. Richard Wolf video cart with "isolating transformer"

7 GA-A 274
 . IMPORTANT!
The persons combining products to form a system are responsible for not impairing the system's compliance with
performance and safety requirements, and that the technical data and the intended use are adequately fulfilled.
Possible electromagnetic or other interference that may occur between the product and other products can cause
faults or malfunctions.
When selecting the system components, make sure that they meet the necessary requirements of the medical envi­
ronment they are used in, in particular IEC/ EN 60601-1 (3. Edition IEC/EN 60601-1, section 16). In case of doubt
contact the manufacturer(s) of the system components.
Do not touch connectors for electrical connections between various components (such as signal input connectors
and signal output connectors for video signals, data exchange, controls etc.) and the patient at the same time.

1.6 Electromagnetic compatibility (EMC)

Please observe the following:
The device/system in the following referred to as product always related to INSUFFLATOR Highflow 45.
The product does not have any performance features classified as essential performance features in accordance with IEC/EN 60601-1.
Guidelines and manufacturer's declaration - Electromagnetic emissions
The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment.
Emissions measurement / test Compliance Electromagnetic environment - Guidelines
The product uses HF energy for its internal function.
HF emissions to CISPR 11 Group 1 The HF emission level is extremely low and it is not likely to cause any
interference in nearby electronic equipment.
HF emissions to CISPR 11 Class B
The product is suitable for use in all establishments, including domestic
Harmonic emissions
Class A establishments. This also includes establishments directly connected to
to IEC 61000-3-2
the public low voltage power supply network that supplies buildings used
In conformity with IEC 61000-3-3 “Emission of voltage fluctuations for domestic purposes.
/ flicker"

Guidelines and manufacturer's declaration - Electromagnetic immunity

The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment.
Compliance
Immunity tests IEC 60601 test level Electromagnetic environment - Guidelines

 6 KV contact discharge Floors should be wood, concrete or ceramic tile.

Electrostatic discharge (ESD)
Yes With floors made of synthetic material, the relative
to IEC 61000-4-2  8 KV air discharge humidity of the ambient air must be at least 30%.
 2 KV for power supply lines
Electrical fast transience, bursts Mains/line power quality should be that of a typical
 1 KV for input and output Yes
to IEC 61000-4-4 commercial or hospital environment.
lines
 1 KV line to line
Surge voltage (surges) voltage Mains/line power quality should be that of a typical
Yes
to IEC 61000-4-5  2 KV line to ground commercial or hospital environment.
voltage
Voltage dip for 0.5 cycle
> 95% UT * Mains/line power quality should be that of a typical
Voltage dip for 5 cycles commercial or hospital environment. If the user of
Voltage dips, short interruptions and sup­ 60% UT * the product requires continued operation during
ply voltage variations Yes
Voltage dip for 25 cycles power mains/line interruptions it is recommended
to IEC 61000-4-11
30% UT * that the product be powered from an uninterrupti­
Voltage dip for 5 sec ble power supply or battery.
> 95% UT *
Power frequency (50/60 Hz) magnetic Power frequency magnetic fields should be at le­
field, 3 A/m Yes vels characteristic of a typical location in a com­
to IEC 61000-4-8 mercial or hospital environment.
* NOTE: UT is the line / mains voltage prior to application of the test level.

GA-A 274 8
Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting
The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment.
Immunity tests IEC 60601 test level Compliance Electromagnetic environment - Guidelines
Portable and mobile RF communications equipment should
be used no closer to any part of the product, including ca­
bles, than the recommended separation distance calculated
from equation applicable to the frequency of the transmitter.

Recommended separation distance:

d = 1.2 p P
d = 1.2 p P for 80 MHz to 800 MHz
Conducted HF interference 3 Vrms d = 2.3 p P for 800 MHz to 2.5 GHz
to IEC 61000-4-6 150 kHz to 80 MHz
P = Nominal power output rating of the transmitter in watts
Yes
(W)
Radiated HF interference 3 V/m (according to the transmitter manufacturer)
to IEC 61000-4-3 80 MHz to 2.5 GHz
d = recommended separation distance in meters (m)
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey1, should be less than the
compliance level in each frequency range2.
Interference may occur in the vicinity of devices with the
following symbol:

REMARKS:
At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec­
tromagnetic waves is affected by absorption and reflexion from buildings, objects and people.
1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio
and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic
site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance
level above, the product should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product.
2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

Recommended separation distances between portable and mobile HF telecommunication devices and devices which
are not life-supporting
The product is intended for use in an electromagnetic environment where HF disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica­
tions equipment and the product.
Separation distance as a function of transmitter frequency (m)
Rated nominal output power of the­
transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 p P d = 1.2 p P d = 2.3 p P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be
determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W).
REMARKS:
At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of elec­
tromagnetic waves is affected by absorption and reflexion from buildings, objects and people.

9 GA-A 274
1.7 Connection diagram - in dialog mode (option)

1.1

1 2
1.1

Legend

Direct connection
1 CAN BUS connection cable (option)
1.1 CAN BUS termination (option)
2 Video cable to meet the signal requirements of the camera controller used

. IMPORTANT!
The optional dialog function is only possible is only possible with enabled software module 3 of INSUF­
FLATOR Highflow 45.
Connection of the CAN BUS connection cable (1) only with interactive camera controller.
If the CAN BUS connection cable is connected, the free CAN BUS connectors of INSUFFLATOR Highflow 45 and
the camera controller must be terminated with CAN BUS terminating resistors (1.1).

GA-A 274 10
2 Illustration

2.1 Front view

5 4 3 2 1.1 1

Legend
1 Power ON/OFF switch
1.1 Power ON/OFF LED
2 Touchscreen
3 Connector for disposable highflow insufflation tube with heating wire
' only 2235021, 2235031 / 2235621, 2235631
4 Connector for reusable highflow insufflation tube with heating wire
' only 2235021, 2235031 / 2235621, 2235631
5 Connector for insufflation tube
(type CF applied part)
6 Connector for smoke gas evacuation
(type CF applied part)
' only 2235011, 2235031 / 2235611, 2235631

11 GA-A 274
2.2 Rear view

13 14

12
15

11 10 8 7

16

FEDERAL LAW RESTRICTS THIS UNIT TO BE

USED OR SOLD, EXCEPT UNDER THE SUPER-
VISION OF A MEDICAL DOCTOR.

Legend
7 Potential equalization connector
8 Connector for footswitch for smoke gas evacuation
' only 2235011, 2235031 / 2235611, 2235631
9 Service interface
10 Silencer
' only 2235011, 2235031 / 2235611, 2235631
11 Power input connector with fuse holder
12 Fuse plate
13 Device connector for gas supply
14 CAN BUS interface
15 Mounting points for bottle holding bracket
16 Identification plate

GA-A 274 12
3 Setup

WARNING!
The device is not protected against explosions.
Explosion hazard.
Do not operate this device in areas where there is a danger of explosion.
WARNING!
Danger if a power supply without protective earth is used.
Danger of electric shock!
Connect the device only to a power supply with protective earth connec­
tor.
. NOTE!
The line / mains voltage must correspond with the voltage indicated on
the identification plate. Connect the device only via the supplied power
cable or a power cable with the same specifications.
Do not block any ventilation slots!
CAUTION!
Danger of faults and malfunctions.
To guarantee the safety of the user, patient and others, use only acces­
sories and spare parts as specified by the manufacturer of this product.
Other accessories or spare parts can cause the emission of increased
electromagnetic radiation or reduced immunity against interference.
. IMPORTANT!
Medical electrical equipment is subject to special precautions with regard
to electromagnetic compatibility (EMC).
Make sure you follow the notes on EMC for installation and operation.
Medical electrical devices can be influenced by mobile HF communication
devices.
If it is necessary to stack the devices or place them next to each other
and HF interference is observed, make sure that the devices are ope­
rated as specified in the intended use.
WARNING!
Use the device only with the insufflation tubes and filters specified by the
manufacturer. Sterilize the insufflation tube before each use.
Danger of infection due to unsterile accessories and possible malfunction
(loss of gas pressure or gas flow) when using spare parts supplied by
other manufacturers or in the case of wrong assembly.
CAUTION!
Disposable items have been designed for one single use only and are
sterilely packed. Do not use disposable items if:
' the sterile packaging is damaged
' the use-by-date has been exceeded
. NOTE!
For use, place the device on a level surface.
. NOTE!
Remove the protective foil from the touchscreen before the first use.

13 GA-A 274
3.1 Language settings
The language is selected in the Device parameters menu (see section 5).
When switching on the device for the first time (setup) as well as during a
new start after having reset the device to "factory settings", the required
language must be selected.
' Language selection for the “Standard profile”.
' For "User-specific operator profile" it is possible to define a separate
language.
Fig. 1
If a wrong language was selected and it is impossible to select the
language selection menu in this language, proceed as follows:
Z Switch off the device and wait for at least 60 seconds.
Z Switch on the device and press the device name on the touchscreen
until the language selection menu is displayed.
Z Let go of the button and select the required language.
' Language selection for the “Standard profile”.

3.2 CO2 connection

3.2.1 Preparation for CO2 operation with gas bottle/cylinder

WARNING!
Make sure that no liquid CO2 enters the INSUFFLATOR Highflow 45 as a
result of incorrect positioning of the gas bottle/cylinder!
This will endanger the patient as a result of possible malfunctions or fail­
ure of the INSUFFLATOR Highflow 45 during the surgical intervention.
Operate the gas bottle/cylinder only in vertical position with the valve on
top.

. IMPORTANT!
Observe the manual for the pressure reducing valve.

18
Z Use mounting screws (15) to attach the bottle holding bracket (18) to
the device if required
' Optionally, large gas bottles/cylinders can be fastened to a device
cart.
15
. IMPORTANT!
When using gas bottles with more than 2 l of volume, use a separate
holding bracket (do not attach to the INSUFFLATOR Highflow 45) and
secure the gas bottle/cylinder against falling over.

GA-A 274 14
 Z Place the gas bottle (max. 2 l of volume) into the bottle holding bracket
and secure with the belt (18.1).
18.1

20.1 19.1
Z Connect the pressure reducing valve (20) to the gas bottle (19) and
19 tighten the union nut (20.1) with your hand.
20
Z Connect the CO2 pressure tube (21) to the pressure reducing valve
21.1 (20) and tighten the union nut (21.1) with your hand.
Z Open the bottle valve (19.1) by turning counterclockwise.
21

3.2.2 Preparation for CO2 operation using centralized gas supply

Connection to a centralized gas supply

17.1 Z Connect the CO2 pressure tube (17) to the device connector for gas
supply and hand-tighten the union nut (17.1).
' Then connect the CO2 pressure tube (17) to the wall connector for
17 centralized gas supply.

3.3 Connecting the insufflation tube set

CAUTION!
Contamination of the device by a backflow of gas or body fluid.
There must always be a hygiene filter between the device connector and
the insufflation tube.

. IMPORTANT!
To connect and disconnect the insufflation tube always hold it by the con­
nectors.

15 GA-A 274
3.3.1 Reprocessable insufflation tubes
D 8170.101: for Veress cannula/RIWO-ART trocar sleeve, dia. 10 mm
(B1) + further models with luer lock fitting
D 8170.232: for high-flow trocar sleeves, dia. 10 mm (B1, B2)

Cut off the luer lock fitting on the insufflation tube and
connect the end of the tube onto the connecting piece (x).

B2
(X)

B1

B1

B2 B1
B1 B1

B2 B2

3.3.2 Disposable insufflations tube

CAUTION!
The disposable insufflation tube is designed for one single use and is sterilely
packed.
Do not use single-use insufflation tubes if:
- the sterile packaging is damaged
- the use-by date has been exceeded

D 4170.501: for Veress cannula/RIWO-ART trocar sleeve, dia. 10 mm

and high-flow trocar sleeve, dia. 10 mm (B) + others with luer lock
connector

Cut off the luer lock fitting on the insufflation tube and connect
the end of the tube onto the connecting piece (x).

(X)

B B B

GA-A 274 16
3.4 Highflow insufflation tubes with heating wire
Optionally, a reprocessable high-flow insufflation tube with heating wire
as well as a disposable insufflaction tube with heating wire and integrated
hygiene filter can be connected to the device.
The plugs are encoded accordingly and can only be connected to the re­
spective socket provided on the device.
For gas heating mode see section 5.

3.4.1 Reprocessable highflow insufflation tube with heating wire

. IMPORTANT!
After autoclaving, the reprocessable highflow insufflation tube with heat­
ing wire must be allowed to cool down for at least 30 minutes. Otherwise,
an overtemperature alarm is triggered after connecting the high-flow in­
sufflation tube to the device.
The reprocessable highflow insufflation tube with heating wire is encoded
and only allows a limited number of applications.
The Device parameters - Device info menu allows the display of the num­
ber of applications already carried out as well as the maximum permiss­
ible number of applications (counts up, e.g. 100 of 100 = end of service
life).
In order to check the number of applications already carried out, the in­
sufflation tube can plugged on briefly without causing the service life to
end.
For manual control, the reusable/reprocessable insufflation tube is fitted
with tear-off tabs. If there is no tear-off tab left on the tube, the reprocess­
able insufflation tube must not be sterilized again.

17 GA-A 274
3.4.2 Disposable highflow insufflation tube with heating wire

The disposable highflow insufflation tube with heating wire is encoded

and only allows one single use.
Go to the Device parameters - Device info menu to display whether the
insufflation tube can still be used (counts up, 1 of 1 = end of service life).

3.4.3 Disposable tube set for smoke gas evacuation

. IMPORTANT!
The disposable tube set for smoke gas evacuation must only be used for
evacuating smoke gas and not for suctioning out liquids.

GA-A 274 18
4 Checks
. IMPORTANT!
Run through the checks before and after each use.
Do not use the products if they are damaged or incomplete or have loose
parts.
Return damaged products together with any loose parts for repair.
Do not attempt to do any repairs yourself.

4.1 Visual check

Z Check the device and accessories for damage, loose or missing parts,
hygiene and completeness.
Z Check all connection cables, tubes and hoses for damage.
Z Any inscriptions, lettering or labeling necessary for the safe intended
use must be legible.
' Missing inscriptions, lettering or labeling leading to wrong handling or
reprocessing must be reinstated.

4.2 Function check

. IMPORTANT!
Before you perform the function checks, make sure that the devices are
in perfect technical condition and are set up correctly. This must also be
guaranteed within the scope of the visual check.
. IMPORTANT!
Before each use, check the INSUFFLATOR Highflow 45 manually for
proper control functions.
This device is equipped with automatic function check routines which
automatically detect and report various types of faults.
The device detects faults and errors that occur during the self test or
during operation.

4.2.1 Device function after switching on the device

Z Switch on the device with the power switch.

' The LED on the power switch lights up.
' When the self test starts also listen to a signal being sounded for
checking the speaker function.
' If during the selftest the gas supply is insufficient, a device message
is displayed and the device is not ready for operation.
' After a successful self test the device is ready for operation.
' The mode selection is displayed.
' Select a suitable profile that suits the mode (see section 5.6).

19 GA-A 274
4.2.2 Checking the gas supply (status message)
Z The CO2 gas supply is displayed in the status display.
' Check that the gas bottle is open and there is sufficient CO2 supply.
' For displaying the fill levels on the status display see section 5.2.2.

4.2.3 Manual checks of the control function

Veress cannula (if used):
Z Check the Veress cannula for patency (free passage) and function
(snap-in mechanism).

Pressure preselection:
Z Change the nominal pressure using the pressure (+) and (-) buttons.
' When insufflation is on, the preselected pressure (nominal value) is
displayed for approx. 2 s.

Flow control (checking the flow):

Z Use the flow (+) and (-) buttons to change the nominal flow.
' The preselected flow rate (nominal value) is displayed for approx. 2 s
when insufflation is switched on.
' In baby mode (option) high flow cannot be selected.

4.2.4 Checking the pressure and flow control

Primary insufflation:
Z Preselect the following nominal pressure: 12 mmHg (mercury column)
Z Connect the hygiene filter and insufflation tube to the insufflation con­
nector.
Z Start insufflation.
' The current flow rate must agree with the preselected flow rate of 1
l/min.
' Permissible tolerance: ¦ 0.5 l/min
Z Close the insufflation tube with your thumb.
' As soon as the current pressure exceeds the preselected pressure,
the device must release pressure.
Z Switch off insufflation and open the insufflation tube.

GA-A 274 20
 Highflow:
Z Nominal pressure to be preselected: 12 mmHg
Flow rate to be preselected: 10 l/min
Z Select highflow.
' First switch on insufflation, then select highflow.
' The current flow rate must agree with the preselected flow rate of 10
l/min.
' Permissible tolerance: ¦ 2.0 l/min
Z Close the insufflation tube with your thumb.
' As soon as the current pressure exceeds the preselected pressure,
the device must release pressure.
Z Open the insufflation tube.
Z Switch back from highflow to primary insufflation.
' After 1.5 s at the latest, a flow rate of 1 l/min ¦0.5 l/min must be dis­
played.
Z Switch off insufflation.

21 GA-A 274
5 Use

5.1 Operating principle

A pneumoperitoneum is established by insufflating CO2 gas into the ab­
dominal cavity. The gas is supplied to the INSUFFLATOR Highflow 45
either from CO2 bottles/cylinders or from a centralized gas supply. The
gas pressure and gas flow rate are controlled by INSUFFLATOR High­
flow 45 in accordance with the specifications of the user.
Microprocessor control and display of the pressure and flow values as
well as several independent safety functions guarantee safe insufflation.
To heat the gas to body temperature, we recommend one of the following
heating tubes (models 2235021, 2235031 / 2235621, 2235631).

5.2 Controls and modes

5.2.1 Operation and display

The device is controlled via the touchscreen and the displays and mes­
sages are also displayed on the touchscreen.

5.2.2 Dispaly of remaining CO2 gas supply in the status display

Z The remaining CO2 gas supply is displayed in the status display.
' If during the selftest the gas supply is insufficient, a device message
is displayed and the device is not ready for operation.

The following fill levels of the gas bottle/cylinder are displayed:

Display Description

Lights up green Sufficient gas supply

Have spare gas bottle/cylinder ready or

Lights up yellow display when connected to centralized
gas supply

Change the gas bottle or in the case of

Blinks red
centralized gas supply: check connection

5.2.3 Gas consumption in status display

The gas consumption is displayed in liters on the touchscreen under

status display and deleted automatically during switch-off (> 1 min).
Reset serves to reset the consumption indicator.

GA-A 274 22
5.2.4 Indicator for gas heating (only 2235021, 2235031 / 2235621, 2235631)

Z When connecting a highflow insufflation tube with heating wire, the

CO2 gas is heated to body temperature.

The following operation modes are displayed in the status display:

Display Description

Blinks green Heating

Lights up green Operating temperature

Blinks red Overtemperature

Errors Heating module deactivated

Symbol empty No heating tube connected

5.2.5 Footswitch for smoke gas evacuation (option)

The footswitch serves to switch smoke gas evacuation ON / OFF.
The smoke gas evacuation pump is only active at pressures > 3 mmHg.

5.2.6 Video on-screen display with dialog function (option)

In conjunction with an interactive (dialog-capable) camera controller, the
dialog function allows the display of device parameters on the monitor.
The above requires a connection between the devices using a CAN BUS
connection cable (see connection diagram in section 1).
For the dialog function optional software module3 must be activated.
The on-screen display of the device parameters on the monitor is the
standard setting (on-screen display can be deactivated in the service
menu).

23 GA-A 274
5.3 Control sequence and menu structure

5.3.1 Overview - control sequence

Mode selection and user-specific profile generated

Switch on the device

Selftest Mode selection Profile selection Main level Menu level

Mode selection and no user-specific profile generated

Switch on the device

Selftest Mode selection Main level Menu level

(standard settings)

GA-A 274 24
5.3.2 Overview - menu structure

User Line/
mains power
ON

Selftest

OK Not OK - error message

Mode selection

Standard profile
Profile selection (option)
User-specific profile

Main level Main parameters

Menu level

Select

Standard profile Selection

Generate new profile Dialog profile name

Change profile name - Dialog profile name

Store profile parameters

Delete profile Delete dialog

Device-specific menu items e.g. parameter control

Device parameters

Display Settings

Audio Settings

Device info Display of device data

Language Settings

Factory setting Dialog resetting

Service

General service Parameters, resets etc.

Authorized persons Device service (protected) Dialog password input

25 GA-A 274
5.4 Menu levels
The device menu is subdivided into 4 areas:
D Main level for user
D Menu level for user
D General service area for user
D Device service for authorized persons - with password only

5.5 Menu control and touchscreen functions

. IMPORTANT!
When controlled via the touchscreen, it is sufficient to touch the monitor
surface slightly.
Do not touch the surface of the touchscreen monitor with sharp,
pointed or contaminated objects as this will lead to reduced image
quality or a damaged surface.
. NOTE!
The illustrations of the user interfaces are only exemplary and vary
depending on the use.

XXXX

XXXX

XXXXXXXX Touchscreen:
The touchscreen monitor is used for information output and the input or
selection of parameters.
XXXXXXXXX - XXXX X

XXXXX

Touchscreen areas:
Area for displays and settings:
When the displayed function is active, the displayed numerical value is
shown in red. The corresponding numerical value is adjusted using the
(+) and (-) buttons or the slide control.
XXXXXXX XXX Status area:
0 100 For approx. 10 s the corresponding status message appears "!" and an
acoustic signal (option) is sounded (e.g. when the lowest or highest
permissible value of the adjustment is reached).
Status area Device parameters:
Indicator for additional parameters, e.g. gas consumption in case of an
Line for main functions insufflator.
Line for main functions:
Calling up the menus, switching on and off device functions, save, delete
etc.

Navigation:
Navigation buttons A = up/down between individual menu items (single
A B steps).
Navigation buttons B = up/down by page or paragraph.
Please note:
The navigation buttons are only active if further menu items can be
called up which are not visible on the first menu page.

GA-A 274 26
 Control elements:

Menu Selected: Button is highlighted, letters are black (button depressed).

Menu Not selected: Button is dark, letters are white (button not depressed).

Menu Selectable: Letters are white.

Menu Not selectable: Letters are gray.

20
Parameter
designation Unit
0 100 Display and parameter setting:
The parameters are displayed as bars and as numbers.
With the (+) and (-) buttons the value can be increased or decreased
and, optionally changed using the slide control (nominal value).
When you keep the (+) / (-) button depressed, the value changes incre­
mentally.
Back

XXXX

XXXX Menu overview - calling up the menus:

XXXXXXXX The Menu button serves to switch from the main level to menu level.
In the menus, any changes in the settings are implemented immediately
after the input.
X mode - Pro­
file
You may exit the menu items with the Back button.
Back

5.6 Selection of main level

The selection on the main level depends on the device version of the
optional software modules and on the device mode. See table in section
8.2.3.
.

27 GA-A 274
5.7 Selection of device modes

Device mode Description

Device operating mode

In a device with several operating modes, the required mode must be selected each
time after the device was started.
The listing only contains the profiles that are assigned to the mode operation.
Optionally, the device modes can be combined (see section 8.2.3).

Default In the case of primary insufflation via a Veress cannula (1l/min).

In the case of minilaparotomy – primary insufflation via Veress cannula is not applica­
Highflow
ble.

Special mode for newborns and babies. Precise pressure and generation of flow in
Baby mode (option)
steps of 0.1 l.

Continuous flow mode with a maximum flow of 8 l/min (only in conjunction with smoke
TEM (option)
gas evacuation).

Continuous flow (option) Continuous flow mode for laparoscopy/thoracic surgery at a maximum flow of 8 l/min.

5.8 Selection of Richard Wolf profiles

Richard Wolf profile Description

Richard Wolf profiles:

The Richard Wolf profiles represent recommended settings for the corresponding field
of application. The listing only contains the profiles that are assigned to the mode of
operation.
Except for the standard profile (default profile), the profiles can be deleted. New self-
created profiles can be incorporated at any time.

Default Recommended settings for standard laparoscopy.

Gynecology Recommended settings for laparoscopic interventions in gynecology.

Urology Recommended settings for laparoscopic interventions in urology.

5.8.1 Changing the standard profiles (default profiles)

Profiles Description

The profiles can be selected in the Operation - Profiles menu.

Standard profiles
After switch-off, the settings are reset to the initial values.

The preconfigured Richard Wolf profiles (e.g. urology, gynecology) can be changed or
Richard Wolf profiles deleted as required. After a reset to the "factory setting", the stored profiles are
reinstated.

Resetting the user-specific During a reset to the factory settings, the custom profiles are deleted and the Richard
profiles Wolf profiles are reinstated.

GA-A 274 28
5.9 Profiles

Standard profile Custom profiles:

1. Dr. Bones In the Profile menu, additional custom profiles can be generated and
2. TEP hernia edited.
Please note:
3. New profile
In order to store changed parameters, open the user profile again (dis­
play in red letters) and confirm the settings with Save profile (see the
following overviews).
Save profile Delete profile Back

Overview - Generating/editing and deleting profiles

Select

Active Single step Up/down by page or paragraph

Selection possible
Not active
Selection not possible

Generate profile Change profile name Delete profile

Standardsetting
Standard profile Standardsetting
Standard profile Standard setting
Standard profile

1. New profile 1. Dr. Bones 1. Dr. Bones

2. New profile 2. TEP hernia 2. TEP hernia

3. New profile 3. New profile 3. New profile

Save profile Delete profile Back Save profile Delete profile Back Save profile Delete profile Back

Please enter profile Please enter profile

Dr. Bones C TEP hernia C
name: name: Do you really want to delete the profile?
1 2 3 4 5 6 7 8 9 0 ´ 1 2 3 4 5 6 7 8 9 0 ´

Q F E C T Z U I O P Ü Q F E C T Z U I O P Ü

A S D F G H Y K L Ö Ä A S D F G H Y K L Ö Ä

Y X C V B N M ,< . - Y X C V B N M ,< . -

OK Cancel OK Cancel OK Cancel

Accept new profile Accept changed profile Cancel

Delete profile
name name delete

Select different profile

Standardsetting
Standard profile

1. Dr. Bones

2. TEP hernia

3. New profile

Save profile Delete profile Back

The selected profile is

accepted.

29 GA-A 274
 Select
Overview - Changing the settings in a profile
Active
Example: Change display brightness Selection possible
Not active
Select Selection not possible
profile

Select Standard profile

Device-specific functions 1. Dr. Bones

Device parameters 2. TEP hernia

3. Dr. Muster

Back Save profile Delete profile Back

Select Display
Device-specific functions Audio
Device parameters Device info

Language

Dr. Bones Dr. Bones

Back Back

Adjust
Display
Adjust brightness
min.
80 max.

brightness
Automatic brightness control

Back

Please note:
After changing a parameter, the setting must be saved
Display
in the "Profile" menu.
Audio
A red profile name and the red "save profile" button
indicate that the changed setting has not yet been Device info
saved. Language
Any settings that haven't been saved are lost when
changing between the profiles or in case of a restart. Dr. Bones

Back

Standard profile Select

1. Dr. Bones Device-specific functions

2. TEP hernia Device parameters

3. Dr. Muster

Dr. Bones

Save profile Delete profile Back Back

Accept setting

GA-A 274 30
5.10 Device parameters

Display

Audio Overview of device parameters:

Device info Via the Device parameters menu, call up the list of submenus for chan­
ging the parameters.
Language
Further parameters, if available, can be displayed using the navigation
buttons.
Back

5.10.1 Adjusting the device parameters

Display
Adjust brightness
min. 80 max.
Adjusting the touchscreen brightness:
In the Display submenu, the brightness or automatic brightness control
of the touchscreen can be selected.
Automatic brightness control The brightness of the touchscreen is adjusted using the (+) and (-) but­
tons or the slide control, respectively.
In the "automatic brightness control" setting manual adjustment is not
possible. In this mode, the brightness of the touchscreen is automatically
Back
adapted to the brightness of the environment. This avoids poor legibility
(too dark) or glare (too bright) of the touchscreen.

Volume
XXX
min. 50 max.
Volume adjustment:
In the Audio submenu, the volume of the key tones, acoustic operator's
notes and alarms can be adjusted.
Acoustic operator's notes
To adjust the volume of the audio signals, use the (+) and (-) buttons or
Button sound the slide control.
With the Key tone button or the acoustic operator's notes button acoustic
signals for the operation of the keys or operator's notes can be switched
Back off and on. The alarms cannot be switched off.

RICHARD WOLF GMBH

Device names: Device number:
Highflow 45 XXXX
MAC address: Device info:
Serial number: XX-XX-XX-XX-XX-XX
XXXXXXXXXX
The device parameters are displayed in the Device info submenu.

Back

31 GA-A 274
 British English

US English
Language selection:
German
The "Language" submenu displays the selected language. Here you may
Français select the required language.
The navigation buttons can be used to select other languages.

Back

Selected menu language:

XXXXX Select language and confirm with OK or return to language selection

using Cancel. If there is no input for 5 seconds the window will close
automatically.

OK Cancel

Factory setting:
Do you want to reset the device to factory
setting? The Factory settings submenu resets all settings to the delivery state.
Confirming the factory settings with OK resets all settings and deletes all
Profiles (custom settings) and automatically the device is restarted.
After the restart the language selection is displayed. This language
setting defines the language of the "Standard profile".
OK Cancel

5.11 Display of actual and nominal values

Display of numerical value in red = actual value

Display of numerical value in gray = nominal value
Bar indicator = actual value

The nominal value cannot be adjusted via this slider.

When touched, the nominal value is displayed in gray as a numerical
value.

The nominal can be adjusted via this slider.

When touched, the nominal value is displayed in gray as a numerical
value.

GA-A 274 32
5.11.1 Service
. NOTE!
All menu screens in the service area are exclusively in English.

General service
General service:
Service area for the user.
Device service (protected)
Device-related display, resets and settings.
Please note:
To leave the service area the device must be switched off and then on
! Message text ! again.
Device service (protected):
Back
Only for authorized persons with a password.

5.11.2 General service

Device info and "Device Info" resets:

Display of device-specific parameters (e.g. type/SN).

Information - Mainboard "Info WXB":

Display of software/hardware information for the mainboard.
Information - Function board "Info FB":
Display of software/hardware information for the function board.
"System Settings":
Setting the system ID for the core system (standard = 1).
Start and implementation of the touchscreen calibration.
"Logfile" protocol:
Certain events are recorded (e.g. resets, updates, faults etc.).
Activation of software modules:
Optional software modules can be activated at a later point in time.
The license code for activation can be obtained from the manufacturer.
For this purpose it is necessary to specify MAC address (Device Info) of
the device. The license code generated by the manufacturer must be
entered via the keyboard.

Calibrating the touchscreen:

Crosshairs appear consecutively in the corners of the display. Try to
press on the crosshairs as precisely as possible.
When all 4 crosshairs have been actuated, the calibration can be saved
with the Confirm Touch Calibration button.
The Restart button serves to restart the calibration.
The Cancel button stops calibration.

33 GA-A 274
5.12 Operation of INSUFFLATOR Highflow 45
CAUTION!
Danger of infection due to unsterile accessories.
Sterilize the reprocessable containers and accessories as described in
section 6.
Discard used disposable items after each use as required by the laws
and regulations valid in your country.
Follow the sterilization rules for the different products!
CAUTION!
The products have only limited strength!
Applying excessive force will lead to damage, impair the function and
endanger the patient.
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.
Do not use the products if they are damaged or incomplete or have loose
parts.
. IMPORTANT!
Before you start laparoscopy observe and carry out the measures de­
scribed in section 3 "Setup" and section 4 "Checks".
. IMPORTANT!
Before each use, check the INSUFFLATOR Highflow 45 manually for
proper control functions.

5.12.1 Important note for using the reprocessable highflow insufflation tube with heating wire
The reprocessable highflow insufflation tube with heating wire heats the
insufflation gas to body temperature.
In the case of low gas flow rates (0.1 l/min - 1 l/min) the tube set temper­
ature on the outside may exceed 50 °C!
The actual gas flow rate depends on the overpressure generated in the
abdomen. The preset maximum nominal gas flow is only reached as long
as no or only a very slight overpressure is measured in the abdomen.
Otherwise, the gas flow is of secondary importance relative to the pres­
sure, i.e. it may be reduced to less than 1 l/min during the operation even
though higher settings were chosen.

To avoid possible injuries of the patient, user or others, make sure that
the following precautions are observed:
D Make sure that the tube set is not connected to the patient for more
than 1 minute.
D Avoid direct contact between the tube set and the patient.
D Before the operation, place the tube set in such a way that it either
does not touch the patient at all or that the contact surface is well insu­
lated (several layers of sterile cloth or gauze between the tube set and
the patient).

GA-A 274 34
5.12.2 Notes and instruction for using smoke gas evacuation

. IMPORTANT!
The disposable tube set for smoke gas evacuation must only be used for
evacuating smoke gas and not for suctioning off liquids.
D Smoke gas evacuation can only be activated in the "Highflow" device
mode.
D Smoke gas evacuation is not available in Baby mode (option).
D The smoke gas evacuation pump is only switched on at pressures > 3
mmHg and is switched off automatically at pressures < 3 mmHg.
D Smoke gas evacuation can be activated and deactivated via the touch­
screen using the Evacuation button or via the footswitch (option).

5.12.3 Creating a pneumoperitoneum

Primarily the hospital's own specifications and routines must be followed
(primary insufflation via Veress cannula or minilaparotomy (open ac­
cess)).

Firstly select the device mode:

"Standard" device mode (access with Veress cannula)
D Start primary insufflation by pressing the Insufflation button.
D Press the Highflow button to switch to highflow insufflation.

"Highflow" device mode (access via minilaparatomy – open access)

D Start highflow insufflation using the Insufflation button.

5.12.4 Highflow device mode

WARNING!
Danger of gas embolism.
The "Highflow" device mode should only be used under endoscopic view.

. NOTE!
If insufflation at a highflow rate is used over a prolonged period of time,
the CO2 gas supply may cool down and cause a transitional drop in the
gas pressure of the supply container. At the same time an operator's note
is displayed.
When insufflation is stopped, the original gas pressure will build up again
in the supply tank/cylinder.

35 GA-A 274
5.12.5 Measures after carrying out insufflation

. IMPORTANT!
Close the gas bottle/cylinder valve after the application. Any leaks at
bottle/cylinder valve or on the connection can cause the gas bottle/cy­
linder to be completely emptied after some time.
Z Close the gas bottle/cylinder valve.
Z Remove and discard the hygiene filter.
Z Discard or reprocess, respectively, the insufflation tube.

5.12.6 Possible alarms during the application

Overpressure alarm:
Possible causes:
D The patient strains muscles as the anesthetic effect gets weaker.
D The user exerts pressure onto the abdomen.
D Additional gas or liquid flow into the abdomen.
Gas supply alarm:
D See section 5.2.2

5.12.7 Power failure

In the case of a power failure (< 30 s), the selected modes of operation
are saved (and remain active). After reestablishing the power supply, you
may continue with the setting previously selected.

5.12.8 Taking out of service

Z To take the device out of service, switch off the power switch and dis­
connect the device from the power supply / mains.

GA-A 274 36
5.13 Overview of operator messages

5.13.1 Structure of operator messages

There are 4 different types of messages.
Message text
The device messages are displayed in the corresponding color together with a
XXX-XXX-XXX symbol and the associated message number, as required by the message type.
optional fault correction
For certain messages the core system will only display the "Follow messages on
device" note.
Please note:
OK In the tables, only the last 3 digits of the message number are displayed.

5.13.2 Message types

Symbol Color Message type Description Alarm sequence

Informs about certain events.

Green Operator's note (Audio signal can be activated/deactivated in the -------
"Audio" menu).

1 alarm pulse
Informs the user about imminent dangers.
Turqoise LOW error Symbol does not
Error of low priority.
blink.

Informs the user about imminent dangers. 3 alarm pulses

Yellow MEDIUM error
Error of medium priority. Symbol blinks

Indicates severe device errors which exclu­

10 alarm pulses
Red HIGH error des any further control of the device.
Symbol blinks
High-priority faults.

5.13.3 Functionality of control elements

Control element Description

No button The message window is displayed until the conditions are fulfilled.

The message window can be exited.

OK
The operation of the device may continue but with limited functions.

The audio alarm signals are activated.

Audio
The audio alarm signals can be switched off by pressing the button.

The audio alarm signals are deactivated.

Audio
Pressing the button switches on the acoustic alarm signals.

Service Once this button is displayed, you can only switch to the "Service" submenu.
The device can no longer be operated.

37 GA-A 274
5.13.4 Operator's messages (green)

Message
Message text Possible cause Corrective action
number
During the runtime a connection
xxx-xxx-005 Connection to core system established to the core system has been ' Status message
established
During the runtime the connection
xxx-xxx-006 Connection to core system disconnected to the core system was inter­ ' Status message
rupted
Language switchover by the core
xxx-xxx-007 Language switchover by core system successful ' Status message
system
xxx-xxx-008 Upper range limit reached ------- ' Status message
xxx-xxx-009 Lower range limit reached ------- ' Status message
Please wait, the device parameters are being
xxx-xxx-010 ------- ' Status message
reset!
xxx-xxx-011 Memory access, please wait ------- ' Status message
xxx-xxx-012 Please wait, profile is being deleted ------- ' Status message
xxx-xxx-013 Please wait, a new profile is generated ------- ' Status message
Maximum number of profile entries is reached
xxx-xxx-014 To generate a new profile, an existing profile must Maximum profile entries reached ' Carry out message
be deleted.
Invalid profile name
xxx-xxx-015 Please enter profile name again. The name must Incorrect profile name input ' Carry out message
contain at least 1 alphanumeric character.
The profile name entered already exists
xxx-xxx-016 Double profile name ' Carry out message
Please enter a different name
To exit the service menu, a device restart is requi­ Message when logging into the
xxx-xxx-018 ' Status message
red. service area
xxx-xxx-019 Wrong service password Password spelling error ' Status message
xxx-xxx-020 Please wait ------- ' Status message
xxx-xxx-021 Function cannot be activated ------- ' Status message
xxx-xxx-027 Please restart device A device restart is necessary ' Carry out message
' Open gas bottle/cylinder or
connect full gas bottle/cylinder
xxx-xxx-436 Insufficient gas supply Gas supply interrupted ' If this message occurs
repeatedly although the gas
xxx-xxx-437 Please check the gas supply CO2 pressure sensor defective
bottle/cylinder is full and the
valve is open, contact the ser­
vice department

5.13.5 LOW error (turqoise)

Message
Message text Possible cause Corrective action
number
' Confirm with OK button -
Profile data not correctly initialized
automatic device restart
xxx-xxx-017 Press "OK" to delete the profile data and set to EEPROM memory error
' If fault occurs again, contact
default values.
service department
' Allow the device to cool
down
xxx-xxx-028 Device temperature too high
Device temperature too high ' Carry out a device restart
xxx-xxx-029 Please allow the device to cool down
' If fault occurs again, contact
service department
Device temperature too low ' Wait until device temperature
Device temperature too low
xxx-xxx-030 (outside the permissible operating meets the required operating
Please allow the device to warm up conditions
conditions)
xxx-xxx-031 Device error - Temperature sensor defective Temperature sensor defective ' Contact service department.

GA-A 274 38
 Message
Message text Possible cause Corrective action
number
Environment light sensor defective
Environment light sensor defec­
xxx-xxx-033 Automatic brightness control of display is swit­ ' Contact service department.
tive
ched off.
xxx-xxx-034 ' Carry out a device restart
Device error - No connection to core system pos­
to Electronics error ' If fault occurs again, contact
sible
xxx-xxx-036 service department
' Carry out recalibration on the
Faulty touchscreen calibration Saved EEPROM values of the service level (general service).
xxx-xxx-037 The default calibration is used, for recalibration touch calibration are not within
the calibration range ' If fault occurs again, contact
switch to service menu.
service department
xxx-xxx-038 ' Carry out a device restart
Device error - Faulty initialization, device is not
to Electronics error ' If fault occurs again, contact
ready
xxx-xxx-042 service department
Software error - Internal data
xxx-xxx-043 Device error - Data transmission ' Contact service department.
transmision
' Carry out a device restart
Internal operating voltages not
xxx-xxx-061 Device error - Device not ready ' If fault occurs again, contact
okay
service department
' Carry out a device restart
Device error - Faulty initialization, device is not Hardware and software versions
xxx-xxx-062 ' If fault occurs again, contact
ready are not compatible
service department
' Carry out a device restart
Device error - No connection to core system pos­
xxx-xxx-063
sible
core processor update faulty ' If fault occurs again, contact
service department
' Carry out a device restart
The type number/model number
xxx-xxx-064 Device error - type number ' If fault occurs again, contact
saved in the device is faulty
service department
' Carry out a device restart
Device error - Initialization failed
xxx-xxx-066 Electronics error ' If fault occurs again, contact
The device is not ready
service department
Software error - Internal data
xxx-xxx-067 Device error - Data transmission ' Contact service department.
transmision
xxx-xxx-400 Device error - Hardware safety activated Device error ' Contact service department.
xxx-xxx-403
to Device error - Pneumatic component Electronics error ' Contact service department.
xxx-xxx-404
xxx-xxx-405 Device error - Pneumatic test Pneumatic component defective ' Contact service department.
' Carry out a device restart
xxx-xxx-406 Device error - Hardware incompatible Electronics error ' If fault occurs again, contact
service department
xxx-xxx-407 Device error - Smoke gas evacuation module Electronics error ' Contact service department.
xxx-xxx-408 Device error - Electronics Electronics error ' Contact service department.
xxx-xxx-409
Device error - Pneumatic component Pneumatic component defective ' Contact service department.
xxx-xxx-410
xxx-xxx-411
Device error - Electronics Electronics error ' Contact service department.
xxx-xxx-412
xxx-xxx-413 Device error - Gas heating module Electronics error ' Contact service department.
xxx-xxx-415 Device error - Electronics Electronics error ' Contact service department.
xxx-xxx-428 Device error - Gas heating module Electronics error ' Contact service department.
' When actuating the OK but­
ton, the gas heating module is
Device error - Data transmission Software error - Internal data
xxx-xxx-433 deactivated
Gas heating module is deactivated transmision
' If fault occurs again, contact
service department

39 GA-A 274
5.13.6 MEDIUM error (yellow)

Message
Message text Possible cause Corrective action
number
xxx-xxx-032 Device error - Temperature sensor defective Temperature sensor defective ' Contact service department.
Software error - Internal data
xxx-xxx-044 Device error - Data transmission ' Contact service department.
transmision
Software error - Internal data
xxx-xxx-068 Device error - Data transmission ' Contact service department.
transmision

' When actuating the OK but­

ton, the gas heating module is
Device error - Gas heating module
xxx-xxx-414 Electronics error deactivated
Gas heating module is deactivated
' If fault occurs again, contact
service department
xxx-xxx-417
to Device error - Pneumatic component Electronics error ' Contact service department.
xxx-xxx-419
xxx-xxx-421 Device error - Smoke gas evacuation module Electronics error ' Contact service department.
xxx-xxx-422 Device error - Pneumatic component Pneumatic component defective ' Contact service department.
' Open gas bottle/cylinder or
connect full gas bottle/cylinder
Gas supply interrupted ' If this message occurs
xxx-xxx-424 Device error - No input pressure repeatedly although the gas
CO2 pressure sensor defective
bottle/cylinder is full and the
valve is open, contact the ser­
vice department
xxx-xxx-425 Device error - Pneumatic component Pneumatic component defective ' Contact service department.
xxx-xxx-427 Device error - Electronics Electronics error ' Contact service department.
xxx-xxx-429
Device error - Gas heating module Electronics error ' Contact service department.
xxx-xxx-430

5.13.7 HIGH error (red)

Message
Message text Possible cause Corrective action
number

xxx-xxx-401 Device error - Hardware safety activated Device error ' Contact service department.
Overpressure alarm -
Critical overpressure > 30 mmHg (mercury co­ ' Decrease intraabdominal
xxx-xxx-402 pressure > 30 mmHg (mercury
lumn) pressure
column) for more than 5 s
xxx-xxx-416 Device error - Electronics Electronics error ' Contact service department.
xxx-xxx-420 Device error - Pneumatic component Electronics error ' Contact service department.
xxx-xxx-423 Device error - Electronics Electronics error ' Contact service department.
xxx-xxx-426 Device error - Software Software error ' Contact service department.

GA-A 274 40
6 Operation within the core system

6.1 Functional principle within the core system

In normal operation, the device can be controlled via the core system
using the touchscreen monitor, optional voice control as well as the con­
trols of the device itself.

. IMPORTANT!
Should the core system fail, the device can still be controlled manually via
the controls on the device itself. For a description please refer to the in­
struction manual of the respective device.

6.2 Combining and controlling the device

Via the integrated CAN BUS interface the device can be integrated in the
Richard Wolf core system .
At the CAN BUS interface only the components approved for use with the
core system can be used.
The components must fulfill the requirements in accordance with the cur­
rent instruction manual for the core system, section on "Possible combi­
nations".
The control computer complies with IEC / EN 60601-1 and may therefore
be used in the patient environment.

Further descriptions of use:

D Follow the latest instruction manual for the core system.
D For the operation, menu structure, software updates and configurations
follow the latest version of the core.software manual.
D For a detailed understanding of the device and menu functions, follow
the instruction manuals of the connected devices.

6.3 Setting the system ID

Z Make sure that the same system IDs are set on the insufflator and on
the camera controller as otherwise these devices cannot communicate
with each other.
' The system ID for this device can be found/set in the Device para­
meters - Service - General service - System Settings menu (see sec­
tion 5).

41 GA-A 274
6.4 Connection to the core system

Touchscreen
monitor

RIWO
CONTROL USB
core.control headset connector

CAN BUS

e.g.
INSUFFLATOR
Highflow 45

CAN BUS

e.g.
HIGHLIGHT X300
light projector

CAN BUS

e.g.
Camera

CAN BUS termination

. IMPORTANT!
The device system must be operated via a "galvanically isolated transformer".

. IMPORTANT!
The last device in the CAN BUS chain must be terminated using the supplied terminating resistor.

GA-A 274 42
7 Reprocessing and maintenance

7.1 Reprocessing of device

WARNING!
Prevent humidity from entering the device.
Danger of electric shock!
Before reprocessing switch off and disconnect the device from the power
supply / mains.

Clean the device with a soft cloth moistened with surface disinfectant,
alcohol or spirit.
Follow the disinfectant manufacturer's instructions!

. NOTE!
For a description of the surface cleaning and disinfecting agents for
devices and universal device carts / trolleys and utility carts approved by
Richard Wolf, please refer to manual GA-J020 "Reprocessing of
RICHARD WOLF Heat-stable Instruments".

. IMPORTANT!
Make sure that no humidity enters the device. Do not use any cleaning
agents, scouring agents or solvents on this device.

7.2 Reprocessing of reusable insufflation tubes

. IMPORTANT!
Follow the latest notes and instructions in manual GA-J 020, “Reproces­
sing of RICHARD WOLF heat-stable instruments“.
Do not use disinfectants containing peracetic acid without corrosion
protection, phenols or chlorine components for the reprocessing of Ri­
chard Wolf products.
Strictly adhere to the maximum immersion time in the disinfectants used,
as described by the manufacturers.

WARNING!
Do not reprocess disposable items!
The service life of products marked as disposable i.e. for single use only,
has been designed for only one use in or on a single patient.
If disposable items are reprocessed to be used again, a deterioration of
the product quality cannot be excluded, which will endanger the patient,
the user and others.
In this case, the manufacturer can no longer guarantee product safety
and performance.

43 GA-A 274
7.2.1 Cleaning
Z Rinse out the tubes with a cleaning gun and dry with compressed air.

7.2.2 Sterilization
Steam sterilization:
Z Steam sterilization using a fractional pre-vacuum procedure at 134 C
(272 F).

7.3 Reprocessing of reusable highflow insufflation tube with heating wire

Z For the reprocessing follow the manual of the reprocessable highflow
insufflation tube with heating wire used.

7.4 Maintenance
. IMPORTANT!
In the case of inquiries or in your correspondence please always indicate
the product number and the serial number listed on the identification
plate. Further documentation is available from the manufacturer on re­
quest.

Service hotline: Phone: +49-(0)-7043/35-389

Fax: +49-(0)-7043/35-1209

7.4.1 Maintenance intervals

. IMPORTANT!
To avoid any incidents or damage caused by aging and wear it is neces­
sary to service the product and the accessories at adequate intervals.
Depending on the frequency of use, but at least once a year, have an
expert check the functional and operational safety of the equipment.

7.5 Quarterly check

. NOTE!
A check may only be carried out by qualified operator staff. If the spe­
cified measured values and tolerances are not met, the device must be
checked by an authorized service technician.

. IMPORTANT!
The device must not be used if the specified values are not displayed or
functions are not fulfilled.

7.5.1 Measuring and test equipment

- Insufflation tube (8170.101), original length 2.5 m
- Hygiene filter (4171.111)
- Transparent container (measuring cup)

GA-A 274 44
7.5.2 Checking the pressure and flow control

Primary insufflation:
Z Preselect the following nominal pressure: 12 mmHg (mercury column)
Z Connect the hygiene filter and insufflation tube to the insufflation con­
nector.
Z Start insufflation.
' The current flow rate must agree with the preselected flow rate of 1
l/min.
' Permissible tolerance: ¦ 0.5 l/min
Z Close the insufflation tube with your thumb.
' As soon as the current pressure exceeds the preselected pressure,
the device must release pressure.
Z Switch off insufflation and open the insufflation tube.

Highflow:
D Preselect the following nominal pressure: 12 mmHg (mercury column)
D Preselected the following flow rate: 10 l/min
Z Start insufflation, then switch over to Highflow.
' The current flow rate must agree with the preselected flow rate of 10
l/min.
' Permissible tolerance: ¦ 2.0 l/min
Z Close the insufflation tube with your thumb.
' As soon as the current pressure exceeds the preselected pressure,
the device must release pressure.
Z Open the insufflation tube.
Z Switch back from highflow to primary insufflation.
' After 1.5 s at the latest, a flow rate of 1 l/min ¦0.5 l/min must be dis­
played.
Z Switch off insufflation.

7.5.3 Leakage test

Z Preselect the following nominal pressure: 12 mmHg (mercury column)
Z Fill a transparent container (e.g. measuring cup) with water.
Z Immerse the patient end of the insufflation tube approx. 5 - 10 cm into
the water (5 - 10 cm below the surface).
Z Start insufflation.
' Gas bubbles must be observed at the end of the tube.
Z Switch off insufflation.
' No gas bubbles must emerge from the end of the tube.
Z After the end of the test, the insufflation tube must be removed from
the water container immediately as otherwise vacuum may pull water
into the tube.

45 GA-A 274
8 Technical description

8.1 Troubleshooting
. IMPORTANT!
If the faults cannot be corrected with the help of this table, please contact
our service department or return the device for repair.
'Do not attempt to do any repairs yourself!

Errors Possible cause Corrective action

Device is not functional Power switch is not on 'Actuate the power switch
Power cable is not connected 'Connect the power cable
Fuse in device is defective 'Replace the fuse
No line voltage/mains 'Check in-house power supply
No gas flow Insufflation not activated 'Switch on insufflation
Gas bottle/cylinder empty or not open 'Replace or open gas bottle/cylinder
Preselected pressure is exceeded As a result of manipulations of the
user, the abdominal pressure increa­ 'Remove cause
ses
Device defective 'Contact the service dept.
Other devices cause a pressure incre­ 'Remove cause
ase
Pressure won't build up Tube system is leaking 'Check tube and connectors
Flow preselection is to low 'Increase flow preselection
Instrument stopcock is closed 'Open instrument stopcock
Smoke gas evacuation won't start Pressure < 3 mmHg 'Generate pressure > 3 mmHg
Evacuation not actuated 'Actuate evacuation
'Open evacuation tube

8.1.1 Fault in the core system

Errors Possible cause Corrective action

'Check connections
'Replace CAN BUS cable
Device is not logged in the core system Data transfer error
'Set to the same system ID
'Contact the service dept.

GA-A 274 46
8.2 Technical data
Voltage Frequency Power Current Fuse
Product no. consumption rating
Vμ Hz VA A A
2235001
100-240 50 / 60 60 0.6 - 0.2 T 3.15 H
2235011
2235021 100-127 /
50 / 60 80 0.8 - 0.3 T 3.15 H
2235031 220-240
2235601 (USA)
100-240 50 / 60 60 0.6 - 0.2 T 3.15 H
2235611 (USA)
2235621 (USA) 100-127 /
50 / 60 80 0.8 - 0.3 T 3.15 H
2235631 (USA) 220-240

Electromagnetic compatibility EMC to IEC / EN 60601-1-2

Medical devices directive 93/42/EEC Class IIb
Protection against electric shock Type CF applied part
Safety class to IEC / EN 60601-1 ;
I
(UL 60601-1 / CSA C22.2 No.601.1 - for USA)
Degree of protection against the ingress of liquids IP 20 (not protected)
Mode / duty factor Continuous operation
Degree of protection when flammable mixtures are This device is not protected against explosions
present (Do not operate this device in ignitable atmosphere)
8.9 kg (19.5 lbs) to 12.8 kg (28.1 lbs)
Weight
(depending on configuration)
Dimensions WxHxD 300 mm x 160 mm x 455

8.2.1 Application parameters

Insufflation medium med. CO2 (degree of purity > 99.5 %)

Input pressures 4 bar to 7.5 bar

3 mmHg to 25 mmHg (¦ 2 mmHg)

Intraabdominal pressure preselectable in increments of 1 mmHg
(mercury column)
Depending on
Gas flow rate, primary filling 1 l/min (¦ 50 %) device mode
Gas flow rate highflow 2 l/min to 45 l/min (¦ 20 %),
selectable in increments of 1 l/min
Consumption indicator 0 l to 999 l (¦ 20 %)
Gas temperature with heating tube 37 ºC ¦ 2 ºC

47 GA-A 274
8.2.2 Pressure and flow values

Device mode Pressure values min. / max. Flow values min. / max.
Primary insufflation (1l/min)
min.: 3 mmHg (mercury column)
Default min.: 2 l/min
max.: 25 mmHg (mercury column)
max.: 45 l/min
min.: 3 mmHg (mercury column) min: 2 l/min
Highflow
max.: 25 mmHg (mercury column) max.: 45 l/min
min.: 3 mmHg (mercury column) min.: 0,1 l/min
Baby mode (option)
max.: 20 mmHg (mercury column) max.: 2 l/min
Primary insufflation (1l/min)
min.: 3 mmHg (mercury column)
TEM (option) min.: 2 l/min
max.: 25 mmHg (mercury column)
max.: 8 l/min
Primary insufflation (1l/min)
min.: 3 mmHg (mercury column)
Continuous flow (option) min.: 2 l/min
max.: 25 mmHg (mercury column)
max.: 8 l/min
Primary insufflation (1l/min)
min.: 3 mmHg (mercury column)
Gynecology min.: 2 l/min
max.: 25 mmHg (mercury column)
max.: 45 l/min
Primary insufflation (1l/min)
min.: 3 mmHg (mercury column)
Urology min.: 2 l/min
max.: 25 mmHg (mercury column)
max.: 45 l/min

8.2.3 Interfaces

Gas connection NIST connector to EN 739 for CO2

Connection for hygiene filter Conical connector, dia.  15.0 mm, DIN ISO 5356 T1
Power supply connection for highflow insufflation tube
5-pin socket, small
with heating wire, reprocessable
Power supply connection for disposable highflow insuf­
5-pin socket, large
flation tube with heating wire
Conical connector, dia. 15.0 mm,
Connector for smoke gas evacuation
DIN ISO 5356 T1
CAN BUS interface Sub-D socket, 9-pin
Service interface RJ 45

GA-A 274 48
8.2.4 Optional device variants

INSUFFLATOR INSUFFLATOR INSUFFLATOR INSUFFLATOR

Highflow 45 Highflow 45 Highflow 45 Highflow 45
BASIC EVAC HEAT EVAC + HEAT
Options (Basic version) (Basic version (Basic version (Basic version
with with with
smoke gas evacuation) gas heating) smoke gas evacuation
and gas heating)
2235001 2235011 2235021 2235031
Software module 1
Connection to core    
(CAN BUS)
Software module 2
   
Baby mode
Software module 3
Video on-screen display with    
dialog
(CAN BUS)
Software module 4
Continuous flow mode    
(TEM + LAP max. 8 l/min)
TEM -----  ----- 
LAP    

Device mode
   
Default
Device mode
   
Highflow
Device mode
 1)  1)  1)  1)
Baby mode *
Device mode
-----  2) -----  2)
TEM
Device mode
 2)  2)  2)  2)
Continuous flow

 = standard equipment  = option  = possible ----- = not possible

 1) = only in conjunction with software module 2  2) = only in conjunction with software module 4
* = In "Baby mode" evacuation and highflow cannot be activated and are masked off.

8.3 Operating, storage, transport and shipping

+ 10ºC to + 40ºC , 30% to 75% rel. humidity
Operating conditions
atmospheric pressure 700 hPa to 1060 hPa
- 20ºC to + 60ºC, 10% to 90% rel. humidity
Storage, transport and shipping conditions
atmospheric pressure 700 hPa to 1060 hPa

. NOTE!
To prevent damage during transport or shipment of the products we recommend using the original
packaging material.

49 GA-A 274
8.4 Spare parts and accessories

Product no. Designation

64268.007 Device fuse T 3.15 H (pack of 10)
2440.03 Power cable (Europe), 3.0 m
8170.101 Insufflation tube, dia.  5.0 mm, length 2.5 m, reprocessable
8170.232 Highflow insufflation tube, dia.  8.0 mm, length 2.5 m, reprocessable
4170.501 Single-use insufflation tube, length 2.5 m, sterile (pack of 10)
Highflow insufflation tube with heating wire, length 3.0 m, reprocessable, only 2235021, 2235031 /
8170202
2235621, 2235631
Disposable highflow insufflation tube with heating wire and integrated hygiene filter, sterile (pack of
4170502
10), only 2235021, 2235031 / 2235621, 2235631
Disposable tube set for smoke gas evacuation, sterile (pack of 10), only 2235011, 2235031 /
4170503
2235611, 2235631
4170504 Smoke gas blow-off filter, sterile (pack of 10)
4171.111 Hygiene filter, single-use item, sterile (pack of 10)
74021.029 CO2 pressure tube, length 1.5 m
74021.030 Connection tube for centralized CO2 gas supply (Dräger), length 5.0 m
74021.035 Connection tube for centralized CO2 gas supply (Air Liquide), length 5.0 m
74007.056 Pressure reducing valve for CO2, ISO 5145
74007.054 Pressure reducing valve for CO2, DIN EN 738-1
74007.055 Pressure reducing valve for CO2, DIN EN ISO 707 (PIN Index)
74002.267 Space seal for bottle/cylinder connection on pressure reducing valve, ISO 5145
2221.951 Bottle holding bracket, houses CO2 bottles, ( 80 to 90 mm)
2221.952 Bottle holding bracket, houses CO2 bottles, ( 100 to 115 mm)
2046.961 0.75 kg CO2 bottle (approx. 350 l CO2) with DIN connector, ( 80 mm)
2030.1031 Single-pedal footswitch for smoke gas evacuation
35100.115 Silencer (pack of 3), only 2235011, 2235031 / 2235611, 2235631
' Further accessories on request

ISO connector (ISO 5145) DIN connector (DIN EN 738-1) PIN Index connector (DIN EN ISO 407)

The products can be combined as required provided the relevant technical data and intended uses are observed. For
the total overview please refer to the latest catalog sheets and brochures or contact Richard Wolf or your representative.

GA-A 274 50
8.5 Replacing parts

8.5.1 Device fuses

CAUTION!
The specifications of the device fuses must correspond with the fuse ra­
tings on the identification plate.
Use only the fuses specified in the spare parts list.

L Power input connector with fuse holder

2 2 3

Z Switch off the device and disconnect the power cable from the wall
socket and from the power input connector of the device.
Z Unscrew the fuse holder [1] using a screwdriver.
Z Take the fuses [2] out of the fuse holder [1] and replace.
Z Reinsert the fuse holder and push until it clicks in place [3].

8.5.2 Disposal of product, packaging material and accessories

For the disposal follow the laws and regulations valid in your country.
' For further information please contact the manufacturer.

51 GA-A 274