Dräger Infinity Delta Series Manual del propietario
Supplement
Infinity® Delta Series
Infinity® Patient Monitoring Series
Software VF10.1
WARNING
To properly use this medical device,
read and comply with the instructions
for use and this supplement.
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Supplement for Infinity Delta Series Software
Infinity Delta Series Instructions for use
Software VF10.1
©Drägerwerk AG & Co. KGaA
All rights reserved.
Reproduction in any manner, in whole or in part, in English or in any other languages, except for brief
excerpts in reviews and scientific papers, is prohibited without prior written permission of Dräger.
Before using any Dräger devices, carefully read all the manuals that are provided with your device. Patient
monitoring equipment, however sophisticated, should never be used as a substitute for the human care,
attention, and critical judgment that only trained health care professionals can provide.
ACE®, DrägerService®, MultiMed®, DualHemo®, QuadHemo®, Infinity®, Perseus®, SmartPod®,
Trident®, Pick and Go®, Scio®, and OxiSure® are trademarks of Dräger.
PiCCO®, PULSION®, and PULSIOCATH® are trademarks of PULSION Medical Systems.
CAPNOSTAT® is a trademark of Philips.
A-2000, BIS, BISx, Bispectral Index, Microstream, INVOS, and Nellcor are trademarks and registered
trademarks of a Medtronic company.
CNAP® is a trademark of CNSystems Medizintechnik AG.
Masimo®, Masimo SET®, and Signal Extraction Technology (SET)® are trademarks of Masimo
Corporation.
Dismozon® is a trademark of BODE Chemie.
Oxycide® is a trademark of Ecolab USA.
SILICON SOFTWARE © 1989, 90, 91, 92, 93, 94 Microtec Research Inc.
All rights reserved.
Some graphics courtesy of Covidien.
Unpublished rights reserved under the copyright laws of the United States.
RESTRICTED RIGHTS LEGEND Use, duplication, or disclosure by the Government is subject to
restrictions as set forth in subparagraph (c)(1)(ii) of the Rights in Technical Data & Computer Software
clause at DFARS 252 227:7013.
The capnography component of this product is covered by one of the following US patents: 6,428,483;
6,997,880; 6,437,316; 7,488,229; 7,726,954 and their foreign equivalents. Additional patent applications
pending.
All other brand or product names are trademarks of their respective owners.
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For your safety and that of your patients
Mandatory reporting of adverse events
Serious adverse events with this product must be reported to Dräger and the responsible authorities.
Safety information
Definition of Target Groups
Target groups for this product include users, service personnel, and experts.
These target groups must have received instruction in the use of the product and must have the necessary
training and knowledge to use, reprocess, maintain, or repair the product. Contact Dräger for training
options.
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.
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
equipment or other property.
NOTE
A NOTE provides additional information intended to avoid inconveniences during operation.
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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.
Training
Training for users is available via the responsible Dräger organization (see www.draeger.com).
WARNING
Risk of serious personal injury, death or property damage.
The monitor can detach from the docking station and fall if:
– the mount is faulty
– the monitor is not securely locked in the docking station
If any part of the docking station appears faulty, do not install it or attach a monitor to it. Contact
your hospital’s service personnel.
Follow the installation instructions provided with the mount.
Position the docking station in a safe location away from the patient.
To prevent the monitor from falling, ensure that it is securely locked in the docking station.
When securely locked, the Battery Charge indicator located on the lower-left front panel of the
monitor is lit.
For more information on docking the monitor, see the main IFU.
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Introduction
Changes in Delta VF10.1
Starting with Delta VF10.1, the following VGA Display requirement has been removed from the Display
Unit (Kappa only) table under the Displays heading.
Output resolution:
High resolution mode: 1024 x 768
Medium resolution mode: 800 x 600
Low resolution mode: 640 x 480
System Components
Applicable Software Options (on a memory option card) include:
Options for Delta only:
– Delta second PodPort option – Pod Comm
Delta, Delta XL and Kappa:
– 4 to 5 channel option – Delta 4-5 Channels
– 6 to 8 channel option – Delta 6-8 Channels
– 3-Lead ST-segment analysis option –
ST Monitoring
– ARIES option – Aries S/W
– Hemodynamic Calculations option – Hemodynamic Calculations
– ACE full arrhythmia option – Arrhythmia II
– Hemo/Oxy/Vent Calculations option package – Hemo/Oxy/Vent Calculations
– OR mode option (loaded in the monitor)
– OR Single Unit
– OR Mode option (loaded in the IDS or Kappa Advanced Communication Option II) – OR Site
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Cybersecurity and Network Stability
Corrected vulnerabilities that may cause device to reboot, lose functionality, and/or lose communication.
Base Unit
Monitor Rear View – Delta XL
Monitor Setup
Main Menu Setup
Date & Time is no longer a selection in the Main Menu > Monitor Setup > Monitor Options submenu.
Date and time changes are only permitted by qualified hospital technical personnel or Dräger Service
personnel in the password-protected Service menu.
Unit Manager
The Unit Manager menu lets supervisory personnel configure monitoring functions for the clinical staff.
Access to this menu is restricted by a password.
1External (lead-acid) battery
compartment (not supported
with software VF9.0 or higher)
2Connector for docking station
interface plate
3Connector for AC adaptor
4Slot for etCO2 modules
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Unit Manager Menu
Menu Item Description Available Settings
The Alarm Control 1 and Alarm Control 2 submenus:
This menu allows the unit manager to configure alarm annunciation. Open the Unit Manager menu,
click on Alarm Control 1 or Alarm Control 2, and then follow the procedures outlined in this table to
execute the indicated functions.
All Alarms OFF
Reminder tone
(Alarm Control 1
submenu)
A reminder tone to indicate all alarms are
OFF permanently.
–Enabled (default)
–Disabled
Enabled when the All Alarms OFF
feature is set to Enabled. A
reminder tone sounds every
30 seconds at 50% volume.
Audio OFF
Reminder (Alarm
Control 1
submenu)
Allows you to set a reminder when the Alarm
Volume is set to OFF.
–Enabled (default) - When the
alarm volume is set to OFF, a
reminder tone sounds every
30 seconds at 50% volume.
For monitors in OR mode: At the
end of an alarm silence or an
alarm off period, if the alarm
condition is still active, the
parameter box flashes and a
reminder tone (high, medium, or
low) sounds every 30 seconds
at 50% volume.
–Disabled -There is no reminder
tone when alarm volume is set
to OFF.
The CODE Setup submenu
This menu allows the unit manager to configure the monitor for quick emergency response. Open the
Unit Manager menu, click on CODE Setup, and then select and execute functions as described in this
table.
Audio OFF Allows you to lower the alarm volume to OFF
when you press the Code fixed key.
NOTE: The central station continues to
sound audio alarms after you press the
Code key.
–Yes - Temporarily sets the alarm
volume and the minimum alarm
volume to OFF when you press
the Code key.
–No (default) - The alarm volume
and the minimum alarm volume
settings do not change when
you press the Code key (i.e.,
retains prior settings).
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Device Markings
The following table contains symbols that have been modified or added to the table in the section on
device markings in the main IFU.
Caution: This product contains
natural rubber latex which may
cause an allergic reaction
Manufacturer’s reorder code
Date of manufacture Device serial number
Acceptable storage temerature ECG waveform out
Acceptable atmospheric pressure
range
ECG Sync out
Acceptable humidity range Arterial waveform out
Contains DEHP Medical Device
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Biomed
Quick Reference - Biomed Menu
Menu Item Description Settings/Procedures
Mainstream CO2
Component Log
This read-only field contains information to
assist with system upgrades and diagnosing
field issues.
The display is read-only.
Press the Menu fixed key.
Select Monitor
Setup>Biomed>Logs>
Component Log
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