ergoline ergoselect 10 M User manual

Information
Cleaning and Disinfecting
ergoline Medical Devices
201000641000 • Version 2020-10-05 / Rev 00 • English

Cleaning and Disinfecting ergoline Medical Devices 1
Cleaning and Disinfecting
ergoline Medical Devices
201000641000 • Version 2020-10-05 / Rev 00 • English
This document is a supplement to the Operator‘s Manual supplied with each ergoline product.
The complete device documentation includes both the Operator‘s Manual and this document.
The most recent version of all Operator Manuals for specic products are available for down-
load at the ergoline website www.ergoline.com.
All trademarks appearing in this document are trademarks of their respective owners. Their
protection is acknowledged.
No part of this document may be reprinted, translated or reproduced without the manufacturer‘s
written permission.
This document will not be automatically updated. Please contact the manufacturer for the
latest document revision.
ergoline GmbH
Lindenstrasse 5
72475 Bitz
Germany
Tel.: [phone] - 9894 - 0
Fax: [phone] - 9894 - 128
e-mail: [e-mail]
http: www.ergoline.com

2 Cleaning and Disinfecting ergoline Medical Devices

Contents
1Cleaning/ Disinfection – General Information. . . . . . . . . . . . . . . . . . . . . . . . 5
1.1 Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1.1 Approved Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.1.2 Unapproved Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.2 Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2.1 Approved Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.2.2 Unapproved Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
2Cleaning and Disinfecting the Device Components . . . . . . . . . . . . . . . . . . . 7
2.1 Device Surfaces (Plastic / Metal) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.2 Handlebar / Seat (Saddle) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3 Pedals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.4 Displays of Control Terminals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5 Upholstery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
2.6 Blood Pressure Cu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.6.1 Removing the Microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.6.2 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.6.3 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.6.4 Inserting the Microphone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.6.5 Inspection and Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.7 ECG Electrodes / Suction Leads. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.7.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.7.2 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
2.8 SoftTip SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.8.1 Aids for Cleaning / Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.8.2 Manual Cleaning and Disinfection of the SoftTip Sensors. . . . . . . . . . . . . . 12
2.8.3 Cleaning the Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.8.4 Inspection and Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.9 Ear Clip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Cleaning and Disinfecting ergoline Medical Devices 3
Contents

4 Cleaning and Disinfecting ergoline Medical Devices

1 Cleaning / Disinfection – General Information
Cleaning and Disinfecting ergoline Medical Devices 5
1 Cleaning/ Disinfection – General Information
1.1 Cleaning Agents
1.1.1 Approved Cleaning Agents
• 50% isopropanol (isopropyl alcohol)
• Mild detergent (mild soap)
• Neutral cleaning agent (neutral cleaner)
• All products suitable for cleaning plastic
• All products suitable for cleaning sensitive surfaces
1.1.2 Unapproved Cleaning Agents
The use of products containing any of the following active
ingredients is prohibited:
• Ethanol (90%)
• Acetone
• Hexane
• Scouring powder
• Substances harmful to plastic
• Organic solvents
• Ammonia-based cleaning agents
• Abrasive detergents
1.2 Disinfectants
1.2.1 Approved Disinfectants
• Isopropyl alcohol (70%)
• Propanol (35%)
• Aldehydes (2–4%)
• Ethanol (50%)
B. Braun Melsungen AG:
• Hexaquart plus®(0.5% / 5.0%)
• Hexaquart S®(1.5% / 5.0%)
• Meliseptol®
• Melsept SF®(0.5% / 5.0%)
ECOLAB:
• Incidin Foam®
Paul Hartmann AG:
• Bacillol®30 Foam /Bacillol®30 Tissues (10% propan-1-ol,
15% propan-2-ol, 20% ethanol)
Schülke & Mayr GmbH:
• Antifect®AF, FF, FD 10
• Mikrozid®AF (25% ethanol, 35% propan-1-ol)
• Quartamon Med®
• Terralin®(0.5%)

1 Cleaning / Disinfection – General Information
6Cleaning and Disinfecting ergoline Medical Devices
1.2.2 Unapproved Disinfectants
• 100% alcohol, Virex
• HB Quat®
• Conventional detergents
• Conductive solutions

2 Cleaning and Disinfecting the Device Components
Cleaning and Disinfecting ergoline Medical Devices 7
2 Cleaning and Disinfecting the Device Components
2.1 Device Surfaces (Plastic / Metal)
Thoroughly inspect the device and the accessories before
cleaning them:
• Check for damage (visual inspection).
• Check keys/buttons and connectors for proper mechani-
cal function.
• Carefully bend the cables and check for damage, heavy
wear, exposed wires, and bent connector pins.
• Check that all connectors mate properly.
• Clean the surface of the device housing and connection
cables by wiping them with a lightly moistened (not wet)
cloth. Where necessary a domestic non-caustic cleaning
agent or a 70% alcohol solution can be used for grease
and nger marks.
• Immediately wipe o all excess cleaning agent.
Wipe the device surface down with a cloth only moistened
with soap water or a disinfectant.
Make sure that the cloth is not dripping wet to prevent
liquid from entering the device.
2.2 Handlebar / Seat (Saddle)
Only a soft, dry or moistened cloth with one of the cleaning
agents listed in section1.1.1 should be used for cleaning.
The parts should be disinfected after each use with one of
the disinfectants listed in section1.2.1.
2.3 Pedals
Only a soft, dry or moistened cloth with one of the cleaning
agents listed in section1.1.1 should be used for cleaning.
The parts should be disinfected after each use with one of
the disinfectants listed in section1.2.1.

2 Cleaning and Disinfecting the Device Components
8Cleaning and Disinfecting ergoline Medical Devices
2.4 Displays of Control Terminals
The lm on the displays should be cleaned with a soft
cloth and vinegar-based household cleaner. Soak the cloth
in the cleaning agent, wring dry and carefully press the
moist cloth onto the display. Then remove soiling in circular
motion. Finally wipe the cleaned surface with a moist cloth
to remove any residue of the cleaning agent. For disinfec-
tion, we recommend using an alcohol-based disinfectant
according to the manufacturer's instructions.
Never use abrasive cleaners/tools such as steel wool or
scouring agents to remove heavy soiling.
2.5 Upholstery
Wipe the upholstery down with a soft cloth moistened
with soap water.
The cloth should only be moist and not dripping wet.
If the cleaning agents and disinfectants used are caustic
or contain alcohol, they may damage and/or discolor the
upholstery.
2.6 Blood Pressure Cu
2.6.1 Removing the Microphone
Pull the end of the cu through the metal clasp and fold
out the cu.
Pull on the short Velcro tab to open the microphone pocket
and carefully remove the microphone.
Figure 2 – 1: Removing the microphone
2.6.2 Cleaning
Clean the cu and tubing with a moist cloth.
You can use a dishwashing liquid or mild soap water.
Clean the microphone with a cloth moistened with alcohol
or mild soap water.
Allow the microphone to dry before reinserting it in its
pocket.
Warning
Equipment Damage
• Cu, microphone and tubing may not under
any circumstances:
• be immersed in liquids,
• be cleaned in a water bath or in running water.

2 Cleaning and Disinfecting the Device Components
Cleaning and Disinfecting ergoline Medical Devices 9
2.6.3 Disinfection
For disinfection, spray a disinfectant sparingly on the cu,
the tubing and the microphone.
After the exposure time indicated by the manufacturer,
wipe all components dry.
The parts should be disinfected after each use with one of
the disinfectants listed in section1.2.1.
Notice
Strictly observe the manufacturer's instructions
foruse.
2.6.4 Inserting the Microphone
Slip the microphone into the pocket, the metal side facing
the arm.
Guide the microphone cable out of the pocket and to the
right of the Velcro tab. Then close the tab.
Fold the end of the cu over and introduce it into the
metal clasp.
Figure 2 – 2: Inserting the microphone
2.6.5 Inspection and Functional Test
Visually inspect the cu and tubing for damage.
Worn, porous, or otherwise damaged cus and tubing
must not be used.

2 Cleaning and Disinfecting the Device Components
10 Cleaning and Disinfecting ergoline Medical Devices
2.7 ECG Electrodes / Suction Leads
2.7.1 Cleaning
ECG electrodes and suction leads should be cleaned after
each use to ensure optimal hygiene and durability.
Take care not to scratch or damage the surface of the
suction electrodes.
The number of cleaning cycles under normal operating
conditions does not adversely aect the service life.
Thorough cleaning ensures constant, high quality signal
transmission and extends the lifetime.
Only a soft, dry or moistened cloth with one of the
cleaning agents listed in section1.1.1 should be used for
cleaning.
Notice
• Strictly adhere to the manufacturer's instructions
for use of the substances, e.g., regarding dosage
and exposure times.
Warning
Equipment Damage
• Use only cleaning agents and disinfectants
recommended by ergoline. Unsuitable products
may damage the device.
• Do not, under any circumstances, immerse the device in
liquids or allow liquid to enter the interior of the device.
2.7.2 Disinfection
To ensure complete disinfection, the manufacturer's direc-
tions must be strictly observed, the prescribed exposure
times being of particular importance.
The parts should be disinfected after each use with one of
the disinfectants listed in section1.2.1.
• Spray the disinfectant onto the exterior of the suction
leads and the suction cups. Observe the exposure time
specied by the manufacturer.
• In the case of heavy soiling of the suction leads and
suction cups, disinfect their exterior with disinfection
wipes or impregnated cleaning tissues.
• Spray the disinfectant on the inside of the electrodes.
Observe the exposure time specied by the manufacturer.
• Disinfect the sealing lips and electrode surfaces with
disinfection wipes or impregnated cleaning tissues.

2 Cleaning and Disinfecting the Device Components
Cleaning and Disinfecting ergoline Medical Devices 11
2.8 SoftTip SpO2 Sensors
2.8.1 Aids for Cleaning / Disinfection
• Approved, non-protein-xing cleaning agent and disinfec-
tant (preparation in strict respect of the manufacturer's
recommendations).
• Compressed air
• Soft disposable tissues
• Electric cleaning brushes
• Demineralized water
Commercially available cleaning agents and disinfectants
approved for this application based on aldehydes, alcohol,
amines, alkalis, or quaternary ammonium compounds are
suitable for cleaning and disinfecting the SpO2 sensors if
the combination and concentration of active ingredients is
similar to the examples listed below.
Product Name Manufacturer Application
Gigasept Instru AF (glycoderivative) Schülke & Mayr GmbH
www.schuelke-mayr.com
Manual cleaning and disinfection
Gigasept FF (aldehyde) Manual cleaning and disinfection
Perfektan TB Dr. Schumacher GmbH
www.schumacher-online.com
Manual disinfection
Descoton forte (aldehyde) Manual disinfection
Neodisher LM2 Chem. Fabrik Dr. Weigert GmbH & Co. KG
www.drweigert.de
Manual cleaning
Validated alkaline cleaning agents and disinfectants

2 Cleaning and Disinfecting the Device Components
12 Cleaning and Disinfecting ergoline Medical Devices
2.8.2 Manual Cleaning and Disinfection of the SoftTip Sensors
1. After each use and before application on another
patient, the sensor must be carefully cleaned and
disinfected.
It is recommended to reprocess the sensor immediately
after use because dried material is dicult to remove.
2. Disconnect the sensor from the monitor before cleaning
or disinfecting it.
3. Thoroughly rinse the sensor to remove soiling from the
surface.
4. Clean the inner and outer surfaces with a brush or a
disposable tissue impregnated with cleaning agent or
disinfectant (observe manufacturer's instructions). It is
recommended to turn the silicone housing of the sen-
sor inside out for cleaning of the interior. The SoftTip
sensors can be immersed in cleaning solution (see list
of approved cleaning agents).
5. Subsequently rinse the sensor for at least 1 minute in
approx. 200ml of demineralized water. Water must
enter the connector, and the openings in the connector
and socket must be repeatedly ushed and drained.
6. Make sure that the sensor has been throughly cleaned
without any residue.
7. Repeat the entire manual cleaning process if necessary.
8. Manually dry the sensor with a lint-free cloth. Dry the
cavities of sensors with sterile compressed air.
Notice
Safety information
Standards to be complied with
• SoftTip sensors must not be machine-cleaned/
autoclaved.
• SpO2 sensors must not be cleaned in an ultrasonic bath.
Ultrasonic cleaning will destroy the sensors.
• Reprocessing with cleaning agents that react with silicone is
prohibited.
• Instructions for use of the cleaning agent and disinfectant
supplied by the manufacturers must be observed.
• The standard DIN EN ISO 17665-1 2006/11 – Sterilization of
health care products.
• The standard DIN EN 556-1 2002/03 – Sterilization of medi-
cal devices.
• Compliance with hygiene requirements and the relevant,
recognized procedures and regulations.
2.8.3 Cleaning the Cables
• Disconnect the cable from the device.
• Wipe the cables with a moist cloth (soap water) – never
immerse the cables in liquids.
2.8.4 Inspection and Functional Test
Visually inspect the sensors for damage.
Worn, deformed, porous, or otherwise damaged sensors
must not be used.

2 Cleaning and Disinfecting the Device Components
Cleaning and Disinfecting ergoline Medical Devices 13
2.9 Ear Clip
• Wipe the ear clip with a cloth moistened with 70%
isopropyl alcohol.
• After cleaning, wipe the ear clip with a clean cloth
moistened with water.

201000641000 • Version 2020-10-05 / Rev 00 • English
14 Cleaning and Disinfecting ergoline Medical Devices

ergoline GmbH
Lindenstraße 5
72475 Bitz
Germany
Tel.: [phone] - 0
Fax: [phone] - 128
e-mail: [e-mail]
http: www.ergoline.com