Nonin 7600 User manual
Operator’s Manual
Model 7600
4-Channel
Regional Oximeter with
Equanox™ Technology
and Bluetooth
®
Wireless
Technology
For Display Software
Revision 11and Higher
English
0123
Nonin® reserves the right to make changes and improvements to this
manual and the products it describes at any time, without notice or
obligation.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443
USA
+1 (763) 553-9968
(800) 356-8874 (USA and Canada)
Fax +1 (763) 553-7807
www.nonin.com
0123
EC
REP
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
References to “NONIN” in this manual shall imply Nonin Medical, Inc.
Nonin is a registered trademark of Nonin Medical, Inc.
The Bluetooth word mark and logos are owned by the Bluetooth SIG,
Inc. and any use of such marks by Nonin Medical, Inc. is under license.
Other trademarks and trade names are those of their respective
owners.
© 2010 Nonin Medical, Inc.
7839-001-01
CAUTION: Federal law (USA) restricts this device to sale by or on the order of
a licensed practitioner.
Consult Instructions for Use.
i
Contents
Indications for Use............................................................. 1
Contraindications ...................................................................... 1
Warnings ................................................................................... 1
Cautions .................................................................................... 2
Declaration of Conformity with FCC and Canadian Ministry
of Health Rules for Electromagnetic Compatibility................... 4
Federal Communications Commission (FCC) Notice................ 5
Guide to Symbols............................................................... 6
Introduction to the Model 7600....................................... 10
Benefits of the Model 7600 Regional Oximetry System.......... 10
Setting Up the Model 7600 Monitor......................................... 11
Sensor Application .................................................................. 12
Bluetooth Technology ............................................................. 13
Battery..................................................................................... 13
Displays, Indicators, and Controls................................. 14
Displays................................................................................... 15
%rSO2 Displays ..................................................................15
Hemoglobin Index (HbI) Display ........................................ 15
Cumulative Saturation Below Reference Display (AUC) ... 15
Indicators and Controls ........................................................... 16
Using the Model 7600 Regional Oximeter Monitor ....... 20
Verifying System Operation .................................................... 20
Connecting Devices with Bluetooth......................................... 20
Event Mark .............................................................................. 21
Operating Modes and Defaults....................................... 22
Limits Mode............................................................................. 22
Reviewing, Setting, or Changing Alarm Limits................... 23
rSO2 Reference ................................................................. 23
Menu Mode ............................................................................. 24
USER Menu Mode .................................................................. 26
Factory Defaults................................................................. 27
User-Defined Defaults........................................................ 28
Nurse Call Feature............................................................. 29
Language Options.............................................................. 30
Alarms............................................................................... 31
High Priority Alarms ................................................................ 31
Medium Priority Alarms ........................................................... 31
Silencing Alarms ..................................................................... 32
Error Codes............................................................................. 32
ii
Memory and Data Output Features ................................ 33
Patient Data Output................................................................. 33
Memory Features .................................................................... 36
Data Management Software ....................................................36
Care and Maintenance..................................................... 37
Cleaning the Model 7600 and7600B/7600PA ......................... 37
Parts and Accessories..................................................... 38
Troubleshooting............................................................... 40
Service, Support, and Warranty...................................... 42
Service and Support................................................................ 42
Warranty.................................................................................. 43
Technical Information...................................................... 44
Manufacturer’s Declaration ..................................................... 44
Testing Summary .................................................................... 48
Principles of Operation....................................................... 48
rSO2 Accuracy Testing ...................................................... 48
Specifications .......................................................................... 49
Transmitter..........................................................................50
External Monitor Installation Instructions..................... 51
Philips VueLink........................................................................ 51
Components....................................................................... 51
Connection Specifications...................................................51
Connecting the 7600 to the Philips Monitor ....................... 51
Alerts.................................................................................. 56
Figures
Figure 1. Model 7600 Regional Oximeter Monitor .................. 11
Figure 2. Setting Up the Monitor (Two-Channel Trunk
Cable Shown) ....................................................................... 12
Figure 3. Model 7600 Controls and Indicators with
Two-Channel Display............................................................ 14
Figure 4. Four-Channel Display .............................................. 14
Figure 5. Model 7600 Main Menu Screen Buttons.................. 18
Figure 6. Model 7600 Limits Menu Screen Buttons ................ 19
Figure 7. Bluetooth Screen ..................................................... 20
Figure 8. Model 7600 Limits Screen ....................................... 22
Figure 9. Model 7600 Menu Mode Screen.............................. 24
Figure 10. USER Menu Mode Options.................................... 26
Figure 11. RS-232 Serial Data Port .........................................33
Figure 12. 7600 Connection to Philips Monitor ........................52
Figure 13. Philips Indicator on 7600 Display............................54
iii
Tables
Table 1. Labeling Icons ............................................................. 6
Table 2. Display Icons............................................................... 7
Table 3. Button Icons ................................................................ 8
Table 4. Soft Button Icons......................................................... 9
Table 5. Display Indicators and Icons ..................................... 16
Table 6. Front Panel Buttons .................................................. 17
Table 7. Main Menu Buttons ................................................... 18
Table 8. Limits Menu Buttons.................................................. 19
Table 9. Alarm Limit Setting Options....................................... 23
Table 10. Factory Default Alarm Limit Settings.................... 27
Table 11. Nurse Call Setup Options........................................ 29
Table 12. Error Codes............................................................. 32
Table 13. Data Output Format .................................................34
Table 14. Electromagnetic Emissions ..................................... 44
Table 15. Electromagnetic Immunity....................................... 45
Table 16. Guidance and Manufacturer’s Declaration—
Electromagnetic Immunity.................................................... 46
Table 17. Recommended Separation Distances..................... 47
Table 18. Philips Monitor Patient Alarms .................................57
Table 19. Philips Monitor Equipment Alarms ...........................58
1
Indications for Use
Indications for Use
Nonin’s non-invasive Model 7600 4-Channel Regional Oximeter system
is intended for use as an absolute real-time adjunct monitor of regional
hemoglobin oxygen saturation of blood underneath the sensor. It is
intended for spot-checking or continuous monitoring of adult or pediatric
patients weighing greater than 40 kilograms (88 pounds). It is intended for
use in environments including the operating room, surgical recovery,
critical care, emergency room, long-term care, and mobile environments.
Contraindications
Do not use this device in an MR environment.
Explosion Hazard: Do not use in an explosive atmosphere or in the presence
of flammable anesthetics or gasses.
Warnings
This device is intended only as an adjunct device in patient assessment. It
should not be used as the sole basis for diagnosis or therapy decisions. It
must be used in conjunction with other methods of assessing clinical signs
and symptoms.
Use only Nonin-branded oximeter pods, sensors, and accessories. These
sensors are manufactured to meet the accuracy specifications for Nonin
oximeters. Using other manufacturers’ sensors can result in improper
oximeter performance.
Always inspect the device before use. Do not use a damaged device or
sensor. Before using any sensor, carefully read the sensor Instructions for
Use, which contains sensor application information for each sensor.
Protect from exposure to water or any other liquid, with or without AC power.
Use the Model 7600 only with power adapters supplied by Nonin Medical.
As with all medical equipment, carefully route patient cables and connections
to reduce the possibility of entanglement or strangulation.
Use the Model 7600 Monitor only within its designated range (approximately
100 meters (300 feet) spherical radius from 7600 monitor to remote
location). Moving outside this range may cause missing or lost data at the
remote monitoring location.
Memory is cleared if error code E06 appears on the display screen.
This device turns off after approximately 30 minutes when in low battery
condition.
2
Indications for Use
If this device is used adjacent to or stacked with other equipment, the device
should be observed carefully to verify normal operation.
The battery pack must be installed at all times while the device is operating—
even when operating on AC power. Do NOT use the device without batteries.
The use of pods, sensors, accessories, and cables other than those listed in
this manual may result in increased electromagnetic emission and/or
decreased immunity of this device.
The device Nurse Call and Bluetooth features should not be used as the
primary source of alarm notification.
The user must verify the device Bluetooth pairing to ensure the correct
patient is remotely monitored.
Ensure all alarm volumes are set appropriately and are audible in all
situations. Do not cover or otherwise block any speaker openings.
This device is a precision electronic instrument and must be repaired by
qualified technical professionals. Field repair of the device is not possible. Do
not attempt to open the case or repair the electronics. Opening the case may
damage the device and void the warranty.
Cautions
The value of data from the system has not been demonstrated in specific
disease states.
When using this device in an operating room, it must remain outside the
sterile field.
This equipment complies with IEC 60601-1-2 for electromagnetic
compatibility (EMC) for medical electrical equipment and/or systems. This
standard is designed to provide reasonable protection against harmful
interference in a typical medical installation. However, because of the
proliferation of radio-frequency transmitting equipment and other sources of
electrical noise in healthcare and other environments, it is possible that high
levels of such interference due to close proximity or strength of a source
might disrupt the performance of this device. Medical electrical equipment
needs special precautions regarding EMC, and all equipment must be
installed and put into service according to the EMC information specified in
this manual.
Warnings (Continued)
!
3
Indications for Use
Exposure to Radio Frequency Radiation. The radiated output power of the
display device is far below FCC radio frequency exposure limits.
Nevertheless, the device must be used in such a way that the potential for
human contact during normal operation is minimized. To avoid the possibility
of exceeding FCC radio frequency exposure limits, remain at least 20 cm
(8 in.) away from the display unit’s internal antenna during normal operation.
The monitor has been tested and meets allowed limits for exposure.
Portable and mobile RF communications equipment can affect medical
electrical equipment.
Radios and cell phones or similar devices can affect the equipment and must
be kept at least 2 meters (6.5 feet) away from the equipment.
Readings of this device may be affected by the use of an electrosurgical unit
(ESU). Keep electrosurgical/electrocautery instruments away from the
sensors and oximetry pod, as they may cause damage or result in erroneous
readings.
This device is designed to determine regional hemoglobin oxygen saturation
of blood underneath the sensor. Factors that may degrade performance or
affect the accuracy of the measurement include the following:
- excessive ambient light or direct sunlight
- excessive motion
- electrosurgical interference
- metal plate or other foreign object in sensor path
- moisture on the skin
- improperly applied sensor
- incorrect sensor type
- anemia or low hemoglobin concentrations
- cardiogreen and other intravascular dyes
- methemoglobin and other dyshemoglobins
- hemoglobinopathies
- performance has not been verified in the presence of elevated
carboxyhemoglobin or bilirubin
- non-normocapnic conditions or other conditions that affect blood
volume
Batteries are a fire hazard if damaged. Do not damage, mishandle, or
disassemble.
Inspect the sensor application sites at least every 2 to 4 hours to ensure
correct sensor alignment and skin integrity. Patient sensitivity to the sensor’s
adhesive may vary due to medical status or skin condition.
Do not autoclave, sterilize, or immerse this device in liquid or use caustic or
abrasive cleaning agents. Do not use cleaning agents or cleaning products
that contain ammonium chloride.
Cautions (Continued)
!
4
Indications for Use
Declaration of Conformity with FCC and
Canadian Ministry of Health Rules for
Electromagnetic Compatibility
• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota,
55441, declares under its sole responsibility that the Model 7600, to
which this declaration relates, comply with part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) this device may
not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired
operation.
Follow local, state and national governing ordinances and recycling
instructions regarding disposal or recycling of the device and device
components, including batteries. Use only Nonin-approved battery packs.
In compliance with the European Directive on Waste Electrical and
Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as
unsorted municipal waste. This device contains WEEE materials; please
contact your distributor regarding take-back or recycling of the device. If you
are unsure how to reach your distributor, please call Nonin for your
distributor’s contact information.
Data is written continuously when the device is on. If the entire memory is
filled, portions of the oldest record will be overwritten when a new record
begins.
Verify all alarm settings and limits during system startup to ensure that they
are set as intended.
A 2-minute alarm silence is automatically engaged at startup.
A functional tester cannot be used to assess the accuracy of the oximeter
monitor or sensor.
When running on battery power, pairing must be initiated within 2 minutes of
turning the device on or within 2 minutes of pressing the Bluetooth button.
After 2 minutes, the Bluetooth portion of the device turns off to conserve
power.
If this device fails to respond as described, discontinue use until the situation
is corrected by qualified technical professionals.
Cautions (Continued)
!
5
Indications for Use
• Ministry of Health (Canada), Safety Code 6: standards include a
substantial safety margin designed to ensure the safety of all persons,
regardless of age and health. The exposure standard for wireless
mobile phones employs a unit of measurement known as the Specific
Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6W/kg.
Federal Communications Commission (FCC)
Notice
This equipment has been tested and found to comply with the limits for a
class A 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 equipment generates, uses,
and can radiate radio frequency energy. If not installed and used in
accordance with the instructions, it may cause harmful interference to
radio or television reception, 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: (1) Reorient or
relocate the receiving antenna, (2) Increase the distance between the
equipment and the receiver, (3) Connect the equipment to an outlet on a
circuit different from the outlet where the receiver is connected, or (4)
Consult the dealer or an experienced radio/TV technician for assistance.
The Model 7600 is designed and manufactured not to exceed the
emission limits for exposure to radio frequency (RF) energy set by the
Federal Communications Commission of the U.S. Government. These
limits are part of comprehensive guidelines and establish permitted
levels of RF energy for the general population. The guidelines are based
on the safety standards previously set by both U.S. and international
standards bodies. This EUT has been shown to be capable of compliance
for localized specific absorption rate (SAR) for uncontrolled environment/
general population exposure limits specified in ANSI/IEEE Std. C95.1-
2005.
The FCC requires the user to be notified that any changes or
modifications to this device that are not expressly approved by Nonin
Medical, Inc. may void the user’s authority to operate the equipment.
NOTE: No modifications to this device are allowed that in any way affect
or alter its antenna or antenna configuration.
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1
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