Nonin 7600 Operator's Manual

Operator’s Manual

Model 7600

4-Channel

Regional Oximeter with

Equanox™ Technology

and Bluetooth

®

Wireless

Technology

For Display Software

Revision 11 and 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 Av

enue North

Plymouth, Minnesota 55441-5443

USA

[phone]

[phone] (USA and Canada)

Fa

x +1

[phone]

[e-mail]

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 ow

ned by the Bluetoo

th 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

%rSO

2

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

rSO

2

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

rSO

2

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
e

mission 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 populatio

n. 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
mod

ifications 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.

6

Guide to Symbols

Guide to Symbols

This chapter describes the symbols that are found on the Model 7600
system or packaging. Detailed information about functional symbols can
be found in “Displays, Indicators, and Controls.”

Table 1: Labeling Icons



Symbol Description

Caution!

Consult instructions for use.

Defibrillation-Proof Type BF Applied Part (Patient
isolation from electrical shock).

UL Mark for Canada and the United States with respect
to electric shock, fire, and mechanical hazards only in
accordance with UL 60601-1 30EM and CAN/CSA C22.2
No. 601.1.

Non-ionizing electromagnetic radiation. Equipment
includes RF transmitters; interference may occur in the
vicinity of equipment marked with this symbol.

CE Marking indicating conformance to all applicable
directives, including EC Directive No. 93/42/EEC
concerning medical devices.

Serial Number

Lot Number

Indicates separate collection for waste electrical and
electronic equipment (WEEE).

Authorized Representative in the European Community.

IP32

Protected against vertically falling water drops when
enclosure is tilted up to 15 degrees, per IEC 60529.

Storage/shipping temperature range of -30 °C to 70 °C 
(-22 °F to 158 °F).

!

C

L

A

S

S

I

F

I

E

D

US

C

U

L

0123

SN

EC

REP

+70°C

-30°C

7

Guide to Symbols

Tabl e 2: Display Icons

Symbol Description

%rSO

2

Regional Hemoglobin Oxygen Saturation

HbI

Hemoglobin Index

AUC

Cumulative Saturation Below Reference (Area Under the
Curve)

Sensor Alarm

AC Power Adapter LED

Poor Signal

Pod Communication Lost

Alarm Silence

Low Battery

Adjustable Upper Limit

Adjustable Lower Limit

Reference

Trend

Alarm Volume

Brightness

8

Guide to Symbols

Table 3:

Symbol Description

Button Icons

Table 2: Display Icons (Continued)

Symbol Description

Clear Memory

Factory Defaults

User

Defaults

Nurse Call

ON/STANDBY

Alarm Sile

nce

9

Guide to Symbols

Table 4:

Symbol Description

Soft Button Icons

Limits Menu

Menu

Event Mark

Blu

etooth

Plus

Minus

Next

Save

10

Introduction to the Model 7600

Introduction to the Model 7600

Benefits of the Model 7600 Regional Oximetry
System

The Model 7600 Regional Oximetry System with Equanox™ Technology
is a fully integrated, digital, Bluetooth-enabled system for measuring
regional hemoglobin oxygen saturation (rSO

2

) underneath the sensor. It
can be used in virtually any common clinical environment where rSO2
measurements might improve patient outcomes. The following features
and user-defined parameters allow the clinical team to adjust the system
for the needs of the operating environment.

• 4.5-meter (15-foot) trunk cable and monitor mounting features allow

the

system to be conveniently located for viewing without interfering

with surgical and anesthesiology operations.

• Weighing only 1 kg (2 lbs), this highly mobile system has a 3-hour

battery life and 69 hours of memory, which allows for operational
flexibility.

• Trend graph timescale is adjustable from 7.5 minutes to 24 hours,

making it ideal for virtually all clinical application timeframes, and
allowing the clinical team to track relative saturation changes from
baseline.

• Saturation value trends can be read from across the room, and reflect

the actual percentage of oxygen saturation at that moment.

• Saturation event markers identify critical deviations from acceptable

rSO2 trends and include alphabetical sequencing of events and
associated saturation values.

• Area Under the Curve (AUC) displays the integrated, cumulative time

and saturation value below a channel’s reference setpoint.

• Display brightness adjusts for the lighting conditions in each potential

clinical environment.

• Alarm thresholds and volumes are also adjustable to signal

in

tervention at the clinician’s discretion, and to compensate for ambient

noise in each unique clinical operating environment.

• The Nurse Call feature integrates into standard hospital systems.

• RS-232 serial data port allows the 7600 to connect to a PC or an

external monitoring system via a serial cable.

11

Introduction to the Model 7600

Setting Up the Model 7600 Monitor

Carefully remove the monitor and accessories from the shipping carton.
Save the packaging materials in case the monitor or accessories must be
returned. Compare the packing list with the accessories received to make
sure the shipment is complete. The monitor includes these non-sterile
components:

• 7600, Regional Oximeter Monitor (figure 1)

• 7600TC-1, Two-Channel Trunk Cable

• 7600B or 7600PA, Regional Oximeter Pods (qty 2)

• Operator’s Manual

• 7800 PS, Power Supply, 25W

• eVision Patient Data Management Software
The Four-Channel Accessory Kit includes these components:

• 7600TC-2, Four-Channel Trunk Cable

• 7600B or 7600PA, Regional Oximeter Pods (qty 2)

Figure 1: Model 7600 Regional Oximeter Monitor

Detail A: Pod (oximeter)
with Sensor

Display Trunk Cable Pods (contain oximeter)

Detail A illustrates sensor to
pod connec

12

Introduction to the Model 7600

Figure 2: Setting Up the Monitor (Two-Channel Trunk Cable Shown)

Sensor Application

Refer to the sensor Instructions for Use (IFU) for proper sensor
application sites, and sensor application cautions and warnings.

WARNING: 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 conjunctio n
with other methods of assessing clinical signs and symptoms .

WARNING: As with all medical equipment, carefully route patient

cables and connections to reduce the possibility of entanglement
or strangulation.

13

Introduction to the Model 7600

Bluetooth Technology

Bluetooth allows wireless connections between electronic
communications and computing devices. The technology is based on a
radio link that offers fast and reliable data transmissions. Bluetooth uses
a license-free, globally available frequency range in the ISM band—
intended to ensure communication compatibility worldwide.

Nonin’s use of Bluetooth wireless technology allows regional oxygen
sa

turation information to be transmitted through a Bluetooth radio to a
compatible Bluetooth-enabled device. Nonin’s wireless system removes
the connection from the monitor to a remote monitor location, giving
increased ability to move the monitor freely. Nonin’s 7600 monitor uses an
automatically switchable class I/class II Bluetooth radio with a maximum
range of about 100 meters (328 feet) (spherical radius).

The Model 7600 features point-to-point communications, allowing one
master de

vice (the remote monitor) to be paired to one slave device (the
7600 monitor). Once connected, the 7600 monitor will not connect with
any other Bluetooth-enabled device.

Battery

Battery capacity: 7.2 V Li-ion battery pack, 2.4 Ah when charged with the

Model 7600

Operating life (fully charged battery): 3 h

ours minimum

Storage life: 20 day

minimum

Recharge time to 90% capacity: 2.5 hours

maximum

• Follow local, state and national governing ordinances and
recycling instructions regard

ing disposal or recycling of the

device and device components, including batteries.

• Use only Nonin-approved battery packs.

• Batteries are a fire hazard if damaged. Do not damage,
mishandle,

or disassemble.

CAUTIONS:

!

14

Displays, Indicators, and Controls

Displays, Indicators, and Controls

This chapter describes the displays, indicators, and controls for the 
Model 7600.

Figure 3 shows operation when pods are only connected to channels 
1 and/or 2. If pods are connected to ch

annels 3

and/or 4, the system will
automatically display all four channels (figure 4) (four-channel accessory
kit required).

Trunk Connector

%rSO

2

Channel

Displays

On/Standby

Button

rSO2Trendline

Area

rSO2 Channel Displays

Timescale

rSO2 Trendline

Area

AUC

HbI

Channel 1 & 2

Channel 3 & 4

Figure 3: Model 7600 Controls and Indicators with

Tw o-Channel Display

Figure 4: Four-Channel Display

Blue Soft

Buttons

Alarm Silence

Button

rSO

2

Trendline

Areas

Speaker

AC Power

Adapter LED