Infinity Acute Care System Medical Cockpit Instructions for Use VG2 Edition 5 Jan 2015

Typographical conventions

1

Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.

 Bullet points indicate individual actions or different options for action. –

Dashes indicate the listing of data, options, or objects.

(A) Letters in parentheses refer to elements in the related illustration. A Letters in illustrations denote elements referred to in the text.

Screen images Schematic renderings of screen images are used, which may differ in appearance or in configuration from the actual screen images.

Use of terms Dräger uses the term "accessory" not only for accessories in the sense of IEC 60601-1, but also for consumable parts, removable parts, and attached parts.

Any text shown on the screen and any labeling on the device are printed in bold and italics, for example, PEEP, Air, or Alarm settings.

Trademarks Trademark

Trademark owner

Infinity®

Dräger

Acute Care SystemTM

Dräger

Medical CockpitTM

Dräger

2

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

Safety information defintions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Abbreviations and symbols Refer to "Symbols" and "Abbreviations" on page 22 for explanations.

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

3

Definition of target groups For this product, users, service personnel, and experts are defined as target groups. These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. The target groups must understand the language of the present document. The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.

Users Users are persons who use the product in accordance with its intended use.

Service personnel Service personnel are persons who are responsible for the maintenance of the product. Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.

Experts Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product.

4

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

Contents

Contents For your safety and that of your patients. . .

7

Technical Data...

47

General safety information...

8

Infinity C500/C700... Infinity C700 for IT...

48 50

Index...

51

Application... 13 Intended use... 14 Environment of use... 14 System overview... 15 Overview... Infinity C500... Infinity C700... Symbols... Abbreviations...

16 17 19 21 22

Hardware features... 23 Overview... 24 Alarm Bar... 24 Rotary knob... 25 Fixed keys... 26 LEDs... 27 Mounting solutions... 28 Operating concept... 29 User interface... 30 Layout elements... 30 Colors... 34 Customizing the display... 35 Cleaning... 37 Safety information... 38 Reprocessing procedure... 38 Maintenance... 41 Overview... 42 Maintenance of the Cockpit... 43 Inspection... 43 Safety inspections... 44 Disposal... 45 Disposing of the medical device... 46

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

5

This page intentionally left blank

6

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

For your safety and that of your patients

For your safety and that of your patients General safety information...

8

Strictly follow these instructions for use... 8 Maintenance... 8 Accessories... 8 Not for use in areas of explosion hazard or oxygen-enriched atmospheres... 9 Connected devices... 9 Safe connection with other electrical equipment... 9 Connection to IT network... 9 Device combinations... 9 Storing the instructions for use... 10 Information on electromagnetic compatibility . . 10 Virus protection... 12

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

7

For your safety and that of your patients

General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this device.

Strictly follow these instructions for use WARNING Risk of incorrect operation and of incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under "Intended use" on page 14. Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Maintenance WARNING Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts. NOTE Dräger will submit all documents needed for repair on request.

Accessories WARNING Risk due to incompatible accessories Dräger has tested only the compatibility of accessories listed in the current list of accessories. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.

8

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

For your safety and that of your patients

Not for use in areas of explosion hazard or oxygen-enriched atmospheres WARNING Risk of fire

For software-related requirements on the connection of devices or networks to these interfaces observe the relevant documents of these applications.

The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur or in oxygenenriched atmospheres.

Device combinations

Connected devices

If a device combination is not approved by Dräger, the safety and the functional state of the individual devices can be compromised. The operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices.

WARNING Risk of electric shock and of device failure Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the instructions for use for all connected devices and device combinations.

This device can be operated in combination with other Dräger devices or with devices from other manufacturers. Observe the accompanying documents of the individual devices.

Device combinations approved by Dräger meet the requirements of the following standards (if applicabale): –

Safe connection with other electrical equipment

IEC 60601-1, 3rd edition (general requirements for safety, device combinations, software controlled functions) –

IEC 60601-1-2 (electromagnetic compatibility)

–

IEC 60601-1-8 (alarm systems)

Or: CAUTION Risk of patient injury Electrical connections to equipment not listed in these instructions for use must only be made when approved by each respective manufacturer.

–

IEC 60601-1, 2nd edition (general requirements for safety) –

IEC 60601-1-1 (device combinations)

–

IEC 60601-1-2 (electromagnetic compatibility)

–

IEC 60601-1-4 (software-controlled functions)

–

IEC 60601-1-8 (alarm systems)

Connection to IT network The medical device has interfaces to connect to other devices or components. These interfaces are only suitable for connecting devices or connecting to networks that have the physical characteristics described on page 11 and page 48.

Strictly follow the assembly instructions and instructions for use. The Infinity Acute Care System Infinity Medical Cockpits have no essential performance as defined in IEC 60601-1.

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

9

For your safety and that of your patients

Any essential performance in combination with an application using the Infinity Medical Cockpits is listed in the accompanying user documentation of that application.

Storing the instructions for use CAUTION Risk of incorrect use Instructions for use must be kept accessible to the user.

Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided on page 10. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Risk of electric shock Do not connect connectors with an ESD warning symbol and do not touch their pins without implementing ESD protective measures. Such protective measures can include antistatic clothing and shoes, touching a potential equalization pin before and during connection of the pins, or using electrically insulating and antistatic gloves.

WARNING No hardware modification is allowed without the consent of the manufacturer. Hardware modifications could compromise the safe electrical and functional use of the product. If the software of the product is modified according to these instructions for use, appropriate inspection and testing must be conducted to make sure, the equipment is safe to use. WARNING To ensure that the device is properly grounded, connect the power cable to a hospital-grade outlet. WARNING The Infinity Medical Cockpits are not suitable for use in the presence of oxygen-enriched atmospheres or flammable anesthetic mixtures. WARNING Because of the risk of electric shock, never remove the cover of a device while it is in operation or connected to a mains power socket. WARNING Do not operate the device in areas such as: magnetic resonance imaging (MRI) environments, aircraft, ambulance, home or hyperbaric chambers.

All users concerned must be instructed in these ESD protective measures.

10

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

For your safety and that of your patients

WARNING Connect only equipment to the analog and digital interfaces (signal inputs and outputs) of which the connected circuit has max. 24 VDC (max. 30 VDC for the system cable) and is either a touchable SELV circuit according to IEC 60950 or double insulated against primary circuits according to IEC 60601-1. Connect only passive (not separately energized) USB devices. Any devices, or combination of devices, not complying with the requirements mentioned in these instructions for use may compromise the correct functioning of the Infinity Medical Cockpits. Prior to operating the Infinity Medical Cockpits, consult the respective documentation and instructions for use of all connected devices or combination of devices. Anyone connecting additional devices to the signal input or output may configure a medical electrical system, and is therefore responsible for ensuring that the system complies with IEC 60601-1 (3rd edition, clauses 14 and 16) or IEC 60601-1-1 with IEC 60601-1-4, and IEC 60601-1-2 and IEC 60601-1-8. If you have any questions, contact DrägerService. WARNING The table mount (part number MS13222, IACS monitoring applications only) is not intended for transport. Tilting the table mount beyond 5 degrees can affect the stability of the Infinity Medical Cockpits and cause them to fall. WARNING To avoid short-circuiting and otherwise damaging the device, do not allow fluids to come in contact with the device. If fluids are accidentally spilled on the equipment, remove the affected unit from service as soon as possible and contact the service personnel to verify that patient safety is not compromised.

WARNING Avoid direct contact between the external surfaces of the device and the patient. WARNING When mounting the device, make sure the requirements for maximum load and slope of floor are met. Consult the mounting manufacturer’s documentation for detailed information. CAUTION When placing the device, make sure adequate ventilation exists and prevent overheating by positioning these items with at least 2 inches (5 cm) of space around all sides if possible. CAUTION To avoid damaging the touch-sensitive screen, do not allow sharp instruments to touch the front access panel of the Infinity Medical Cockpits. CAUTION The device should only be operated in surroundings that meet the environmental operating temperatures specified on page 48. CAUTION To prevent overheating, do not place the Infinity Medical Cockpits in direct sunlight or near radiant heaters. CAUTION Do not obstruct or close off the vents on the medical device. Air must be able to enter freely. Otherwise the medical device may become too hot. An alarm is triggered if the medical device overheats during operation. CAUTION After extended exposure in a cold environment, take special care to acclimate the device so condensation does not form on the electronic parts which could lead to damage.

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

11

For your safety and that of your patients

Virus protection CAUTION The Infinity Medical Cockpit does not have virus protection software and relies therefore on the firewall of your institution to prevent access to infected files. While setting up IT applications to access web sites, evaluate each web site with regard to possible virus infection.

12

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

Application

Application Intended use... 14 Environment of use... 14

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

13

Application

Intended use The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms

as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

Environment of use WARNING Risk of explosion and fire This medical device is neither approved nor certified for use in areas where oxygen concentrations greater than 25 %, combustible or explosive gas mixtures are likely to occur.

14

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

System overview

System overview Overview... 16 Infinity C500... 17 Front access panel... 17 Back panel... 18 Infinity C700... 19 Front access panel... 19 Back panel... 20 Symbols... 21 Abbreviations... 22

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

15

System overview

Overview These instructions for use provide a general overview of the Infinity Medical Cockpits. Specifically, these instructions for use describe the common user-interface and hardware components for the Infinity Medical Cockpits when used with different application software. Specifically, this document addresses the following topics: –

Common hardware components (for example, the rotary knob and the alarm bar)

–

Common user-interface strategy (for example, navigational tools)

–

Technical specifications

This document does not describe the actual functions of an Infinity Medical Cockpit when it is connected to a specific software application. For such detailed instructions, refer to the instructions for use of the application software. The Infinity Medical Cockpits are the central userinterface and processing center for the various applications of the Infinity Acute Care System. For a dedicated IT solution, the Infinity C700 for IT with a display size of 20 inch (50 cm) is available. NOTE The Infinity C700 for IT is a device that can be used exclusively to run IT applications. Therefore, it is not governed by the same user interface elements used for other IACS applications. For detailed information, see the C700 for IT instructions for use which are shipped with each device.

16

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

System overview

Infinity C500

Front access panel

A

G

F ED

C

C500_Front

H

B

A Alarm bar (use depends on application). Lights up during serious and high-priority alarm conditions in the respective alarm color.

D Battery LED. Indicates battery status (only supported if the medical device features a backup battery).

B Audio pause key (use depends on application).

E AC power LED. Lights up when the device is connected to AC power.

C Rotary knob (use depends on application). The LED inside the rotary knob lights up yellow when you have to press on the rotary knob to confirm an action.

F Power On/Off key G Ambient light sensor (use depends on application). H Power on LED

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

17

System overview

Back panel

A

B

G F E

D

A Alarm bar (use depends on application) B VESA mounting C 3x USB port D 3x Serial communication port RS232 (COM) E 1x Single-link Digital Video Interface (DVI) F 2x LAN 10/100 Mbit/s (RJ45), isolated G 3x USB port

18

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

C500_Back

C

C

System overview

Infinity C700

Front access panel

A

H

C

F ED

B

005

G

A Alarm bar (use depends on application). Lights up during serious and high-priority alarm conditions in the respective alarm color.

D Battery LED. Indicates battery status (only supported if the medical device features a backup battery).

B Audio pause key (use depends on application).

E AC power LED. Lights up when the device is connected to AC power.

C Rotary knob (use depends on application). The LED inside the rotary knob lights up yellow when you have to press on the rotary knob to confirm an action.

F Power On/Off key G Ambient light sensor (use depends on application) H Power on LED

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits

19

System overview

Back panel

A

B

C

C

F E

D 006

G A Alarm bar (use depends on application) B VESA mounting C 3x USB port D 3x Serial communication port RS232 (COM) E 1x Single-link Digital Video Interface (DVI) F 2x LAN 10/100 Mbit/s (RJ45), isolated G 3x USB port

20

Instructions for use Infinity Acute Care System - Infinity Medical Cockpits