Dräger OR-PC 21 Bedienungsanleitung

ALWAYS A STEP AHEAD 3

Table of Contents

1. General notes ....................................................................4

2. Classification and intended use ....................................................4

3. Installation and commissioning....................................................5

3.1 Cable and device connection ..........................................................5

3.2 Device environment, safety and handling instructions ...................................7

3.3 Electromagnetic compatibility (EMC) ...................................................7

3.4 BIOS................................................................................9

3.5 Graphic symbols .....................................................................9

4. Operation.......................................................................10

4.1 Keypad ............................................................................10

5. Maintenance ....................................................................11

5.1 Care and hygiene instructions ........................................................11

5.2 Maintenance intervals and wearing parts ..............................................12

5.3 Malfunctions and alarm signals.......................................................12

5.4 In-house repairs ....................................................................13

5.5 Transport notes for ACL devices ......................................................14

5.6 Environmentally sound disposal ......................................................14

6. Manufacturer contact............................................................15

7. Warranty and guarantee .........................................................15

8. Applicable law...................................................................15

9. Data protection .................................................................15

1. General notes

This manual provides you with an overview of the necessary steps for commissioning and opera-

ting the computer system. Please read them even if you are familiar with the operation of compu-

ter systems.

The term "device" is used below to refer to the OR-PC®21 or OR-PC®24 manufactured by ACL

GmbH for Dräger.

2. Classification and intended use

The device is designed for documentation purposes of data, such as patient-related information

inside and outside operating rooms, intensive care units and similar areas of use. It supports the

local software environment and can be part of the IT data network.

Based on IEC 60601-1:2020, Section 6, the following classification results:

6.2 Protection class I device

6.3 IP20

6.4 The device is not intended for sterilization.

6.5 Operation in an oxygen-enriched environment is not intended.

6.6 The device is suitable for continuous operation.

When connecting devices, it is not permitted to touch the patient and the contacts of connectors

of the signal input or output parts at the same time.

The device is

• a professional ME device as defined in IEC 60601-1-2:2014, para. 3.23,

• suitable for use within the patient environment,

• not suitable for use with direct contact to the patient,

• not intended for operation or maintenance by the patient,

• not approved for use in private households,

• not equipped with fireproof enclosure features according to IEC 60601-1:2020, para. 11.2,

• not explosion-proof, and

• may only be started up, operated or serviced by qualified personnel familiar with the equipment

and this manual.

No information is required on actions to avert dangerous conditions or situations for humans,

animals or the environment.

The connection of third-party devices is permitted under consideration of the restrictions, expla-

nations and case examples cited in Section 3.1.

ALWAYS A STEP AHEAD 5

3. Installation and commissioning

The device was thoroughly cleaned before leaving the factory. However, due to the transport con-

ditions and the transport packaging, neither a sterile nor a disinfected product can be assumed

upon delivery. For the initial cleaning, please observe the instructions provided in Section 5.1.

First check the device and accessories for completeness by comparing with the enclosed delivery

bill.

The device may only be operated in an upright position; operation with an inclination of more than

30° from the normal in one direction is not permitted. Operation in inadmissible positions (upside

down on its head, lying on its back or on its display) is not permitted and may result in damage to

the device.

Only use the screws supplied. Always use all fastening points for safe mounting of the device.

Adequate ventilation is necessary for reliable and continuous operation of the device. Ventilation

protects the device from overheating. Therefore, do not install the device in a location or under

conditions where adequate ventilation of the housing surfaces is not possible. To avoid heat accu-

mulation or interruption of air circulation and to protect the device mounting from possible over-

loads, it is not permitted to place objects or materials on the device or to hang them on the device.

To avoid the risk of injury and damage to the device, all connection cables should be routed so that

no one can step on them, trip over them, or place heavy objects on them. When mounting, ensure

a fixed position and/or stable suspension.

3.1 Cable and device connection

Use only the supplied connection cables.

First connect the potential equalization cable (special green-yellow marking) to ensure sufficient

potential equalization between user and device. Operation in the medical field without connected

potential equalization is not permitted.

Before connecting to a supply network, check the correct voltage and frequency of your power

supply network (see nameplate on the housing). Carefully connect all desired connection cables

(power cable, keyboard, mouse, serial cable, network, etc.) to the device. To avoid the risk of elec-

tric shock, this device must only be connected to a supply network with a protective earth conduc-

tor. Finally, check the tight fit of all cable connections. It is not necessary for the end customer to

attach strain reliefs to the device.

For complete disconnection from the mains, the system mains switch must be actuated or the

mains plug must be pulled out of the socket. When disconnecting from the mains, always grasp

the mains cable by the plug. Do not pull on the cable. Do not place the device in conditions that

make it difficult to disconnect it from the mains power supply.

When establishing an electrical connection with other devices and when operating the device on a

portable multiple socket outlet, ensure compliance with IEC 60601-1 in the currently valid version.

To maintain conformity with the standard, so-called "decoupled interfaces" are provided for this

case for the RJ-45 port (LAN1) and, depending on the configuration, one or both RS232 ports. Data

can be transmitted via these galvanic isolators without a direct electrical connection. From an elec-

trical point of view, the connection of medical devices is permitted at these decoupled interfaces.

At the same time, a functional unit is created when exchanging data with other devices. This

applies in particular if this functional unit has a medical purpose (e.g. control of infusion pumps by

the device, connection of application parts). The validity of any assured standard conformities and

properties of the device would not extend to the new functional unit. Instead, the person placing

the new functional unit on the market is responsible for its conformity to applicable regulations

and standards.

Should the device be brought into contact with other devices, unforeseen interactions or even

malfunctions may occur on one or both devices.

Illustrations: Connection panels on the underside of the device for different product versions

ALWAYS A STEP AHEAD 7

3.2 Device environment, safety and handling instructions

Please observe the safety instructions compiled below to avoid fire, electric shocks, injuries and

damage to the device.

Protect the unit from

• exposure to strong infrared radiation, such as direct sunlight,

• strong magnetic fields, such as those occurring in the immediate vicinity of an MRI,

• the impact of strong electromagnetic radiation,

• exposure to strong ionizing radiation, such as occurs at the C-arm of an X-ray machine,

• as well as from strong shocks and vibrations over longer periods of time.

The device may only be operated under the following environmental conditions:

Operation Storage

Temperature 0 to 35 °C

32 to 104 °F

-10 to 60 °C

14 to 140 °F

Humidity 10 to 90%

non-condensing

5 to 70%

non-condensing

Height 0 to 3.048 m

0 to 10,000 ft

0 to 12.192 m

0 to 40,000 ft

Pressure 105 to 70 kPa 105 to 19 kPa

Store the device for three hours at its new operating location before commissioning if the tem-

perature difference during transport is more than 10 °C. Rapid temperature changes can cause

damage to the device, e.g. due to condensation.

Avoid displaying the same screen content for an extended period of time. Otherwise, TFT displays

may show afterimages at least temporarily (image sticking effect).

3.3 Electromagnetic compatibility (EMC)

The use of cables and accessories other than those supplied may adversely affect EMC. Under

certain circumstances, this may mean that compliance with the limit values assured at the time of

delivery can no longer be assumed.

Output lines intended for direct connection to lines in the outdoor area are not covered within the

scope of the warranted EMC properties of the device. Additional tests may be necessary for this

purpose.

Stacking devices and mounting them in close proximity to other electrical devices may cause

interference and malfunction of both devices. Ensure sufficient distance or appropriate shielding

between the devices.

The device is intended for operation in an electromagnetic environment with controlled RF dis-

turbances. Electromagnetic interference can be avoided by observing the distances to mobile HF

telecommunication devices (transmitters) specified below to prevent performance degradations.

These minimum distances depend on the output power of the communication device but must not

be closer than 30cm between portable HF telecommunication devices and any point of the unit or

its cables.

Interference emission mea-

surements

Matching Electromagnetic environment - Guidelines

HF emissions according to

CISPR 11

Group 1 The device uses HF energy exclusively for its internal

function. Therefore, its HF emission is very low and

it is unlikely to interfere with adjacent electronic

devices.

HF emissions according to

CISPR 11

Class B tested for both environmental conditions (IEC 60601-

1-2/5.2.1.1)

Emissions of harmonics accor-

ding to IEC 61000-3-2

Class D The device is suitable for use in facilities other than

residential and those directly connected to the public

utility network, which also supplies buildings used for

residential purposes.

Voltage fluctuation/flicker

emissions according to IEC

61000-3-3

complies

Nominal power of the

transmitter in W

Protective distance, depending on the

transmitting frequency in m

150 kHz to <80 MHz 80 MHz to <800 MHz 800 MHz to 2.7 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters whose maximum rated power is not specified in the above table, the recommen-

ded protective distance (d) in meters (m) can be determined using the equation associated with

the respective column, where:

• P is the maximum rated power of the transmitter in watts (W) as specified by the transmitter

manufacturer;

• U1 is the maximum permissible field strength according to IEC 61000-4-6 (3V RMS outside the

ISM bands, 6V RMS in the ISM and amateur radio bands);

• E1 is the maximum permissible field strength according to IEC 61000-4-3.

Note:

These guidelines may not be applicable in all cases. The propagation of electromagnetic quantities

are affected by absorption and reflection of the buildings, objects and people.

ALWAYS A STEP AHEAD 9

Electromagnetic immunity test Test level

High frequency electromagnetic fields

acc. 61000-4-3

IEC 60601-1-2:2014 table 4, home care;

IEC 60601-1-2:2014 table 9

ESD (electrostatic discharge) acc. IEC 61000-4-2 IEC 60601-1-2:2014 table 4;

IEC 60601-1-2:2014 table 8

Electrical fast transients / bursts acc. IEC 61000-4-4 IEC 60601-1-2:2014 Table 5

Surge acc. IEC 61000-4-5 IEC 60601-1-2:2014 Table 5

Conducted disturbances induced by RF fields

acc. IEC 61000-4-6

IEC 60601-1-2:2014 Table 5, home care;

IEC 60601-1-2:2014 Table 8, home care

Voltage dips and voltage interruptions

acc. IEC 61000-4-11

IEC 60601-1-2:2014 Table 5

Rated power frequency magnetic fields

acc. IEC 61000-4-8

IEC 60601-1-2:2014 Table 4

Electro surgery interference IEC 60601-2-2 Annex BB, mono cut, monopolar coagu-

lation – spray

3.3.1 FCC Statement

This unit has been tested and found to comply with the limits for a Class B digital device, pursuant

to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against

harmful interference in a residential installation. This unit generates, uses and can radiate radio

frequency energy and, if not installed and used in accordance with the instructions, may cause

harmful interference to radio communications. However, there is no guarantee that interference

will not occur in a particular installation. If this unit does cause harmful interference to other de-

vices, which can be determined by turning the equipment off and on, the user is encouraged to try

to correct the interference by one or more of the following measures:

• Increase the separation between the unit and other devices even beyond the distances listed in

section 3.3 if necessarry.

• Consult the manufacturer at the adress listed in section 6.

3.4 BIOS

The BIOS can be called up with the "Del" key when starting the device. The BIOS settings of the

device are password-protected by default to prevent malfunctions caused by improper settings.

BIOS password ex works: asdf9

3.5 Graphic symbols

Depending on the equipment version of your product, the following symbols and notes may have

been used on your device:

Symbol Meaning Source

CE marking 2006/95/EC Annex III

E500364

MEDICAL – GENERAL MEDICAL EQUIPMENT

AS TO ELECTRICAL SHOCK, FIRE AND MECHA-

NICAL HAZARDS ONLY IN ACCORDANCE WITH

ANSI/AAMI ES60601-1: A1:2012, C1:2009/I2012

und A2:2010/I2012,

CSA CAN/CSA-C22.2 NO. 60601-1:14

Underwriter Laboratories LLC

EAC mark CU TR 004/2011

This equipment has been tested and found

to comply with the limits for a Class B digital

device, pursuant to part 15 of the FCC Rules.

FCC ID: 2AUWB2

47 CFR Part 15

Industrial protection IEC 60529

Observe manual instructions ISO 7010-M002

Do not open device none

AC voltage IEC 60417-5032

and Connection to or disconnection from the

supply network

IEC 60417-5007 resp. IEC 60417-5008

Protective connection, grounding IEC 60417-5019

Potential equalization connection IEC 60417-5021

Fuse rated value EN 60617-2/07-21-01

Manufacturer ISO 15223-1

Date of manufacture ISO 15223-1

WEEE 2002/96/EC Annex IV

ALWAYS A STEP AHEAD 11

4. Operation

The standby button can be used to switch the device on and off. This function corresponds to the

soft start switch of conventional PCs. This does not disconnect the power supply from the mains.

Your device has a capacitive keypad. It is enough to touch the glass pane on the key icon to trigger

the function of the key. To avoid unintentional triggering of the keys during wipe disinfection, the

keys must be pressed for at least 0.5 sec.

To switch off the device, the standby button must be pressed for at least 2.5 sec.

The device confirms all entries with a signal tone.

4.1 Keypad

The device is operated via the front keypad. The assignment of the function keys and LEDs varies

depending on the selected equipment variant.

The following key functions are integrated:

Function keys LED indicators

OEM Dräger Standby Taster, LED seitlich neben Taste

Stand 15.12.2020

OEM Dräger Standby Taster, LED innerhalb des Schlosses

Stand 15.12.2020

Switch on/off

Shutdown in standby

OEM Dräger Standby Taster, LED seitlich neben Taste

Stand 15.12.2020

OEM Dräger Standby Taster, LED innerhalb des Schlosses

Stand 15.12.2020

Deactivate resp. reactivate the touch

ohneNormbezug

Lampeaus

Device off;

disconnected from the mains

ohneNormbezug

Lampeaus

Touch shutdown inactive

ohneNormbezug

Lampeblinkt

Device in standby;

connected to power grid

ohneNormbezug

Lampeblinkt

Touch shutdown active

ohneNormbezug

Lampean

Device switched on

OEM Dräger Standby Taster, LED seitlich neben Taste

Stand 15.12.2020

OEM Dräger Standby Taster, LED innerhalb des Schlosses

Stand 15.12.2020

Illustration: Keypad

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