85652_fcv.

qxd 7/2/2004 12:46 PM Page 1

BIOTREND®
Oxygen Saturation and Hematocrit System

Operator and Reference Manual

0123

85652 Rev3.0
85652_fcv.qxd 7/2/2004 12:46 PM Page 2

85652 Rev3.0
 BIOENM1.TPG 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)
Bioenm1.book Page 1 Friday, July 2, 2004 12:43 PM

BioTrend® Oxygen Saturation and Hematocrit System

Operator and Reference Manual
Medtronic® BioTrend® Oxygen Saturation and Hematocrit System
consists of these components:
BioTrend® Instrument
BioTrend® Sensor Cables (2)
Power Cord

For use with Tri-optic Measurement Cells1

Tri-optic Measurement Cell .64 cm X .64 cm (1/4 in X 1/4 in)
Tri-optic Measurement Cell .95 cm X .95 cm (3/8 in X 3/8 in)
Tri-optic Measurement Cell 1.27 cm X 1.27 cm (1/2 in X 1/2 in)
Medtronic® and BioTrend® are registered trademarks of Medtronic, Inc.
Users must read and understand this manual completely before operating the BioTrend® Oxygen Saturation and Hematocrit System.

 Medtronic, Inc. 2004

All Rights Reserved
1 Tri-optic Measurement Cells are available uncoated or with a biocompatible coating; contact your Medtronic custromer service representative for more
information.

85652 Rev 3.0

 BIOENM1.TPG 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)
Bioenm1.book Page 2 Friday, July 2, 2004 12:43 PM

85652 Rev 3.0

Blank Inside Title Page—For Position Only

Do Not Print!
 BIOENM1.OPN 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 1 Friday, July 2, 2004 12:43 PM

Symbols on the Product or Packaging Symbol Description

Alternating Current
Symbol Description

Conformité Européenne (European “On” Only for a Part of Equipment

Conformity) This symbol means that the
device fully complies with European Council
Directive 93/42/EEC (14 June 1993,
concerning medical devices). “Off/Standby” Only for a Part of Equipment

! USA For US Audiences Only

Battery Charging Condition

AND LISTED by Underwriters Laboratories Inc. to

LISTED LISTED
US and Canadian safety standards Serial Number

Dangerous Voltage Serial Exposure

Risk of explosion if used in the presence of Date of Manufacture

flammable anesthetics

Attention: See Instructions for Use Catalogue Number

Operator and Reference Manual 1

85652 Rev 3.0

 BIOENM1.OPN 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 2 Friday, July 2, 2004 12:43 PM

Symbol Description Symbol Description

Quantity Type BF Equipment (IEC 601-1)

Do not subject to impact or rough handling

Do not place any object on this instrument

Temperature Limitation

Humidity Limitation

Storage Pressure

Lot Number

2 Operator and Reference Manual

85652 Rev 3.0

BIOENM1.OPN 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 3 Friday, July 2, 2004 12:43 PM

Operator and Reference Manual 3

85652 Rev 3.0

BIOENM1.OPN 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 4 Friday, July 2, 2004 12:43 PM

4 Operator and Reference Manual

85652 Rev 3.0

 BIOENM1.TOC 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 5 Friday, July 2, 2004 12:43 PM

Table of Contents Instrument Setup 17

Instrument Self-Test 19
Operator and Reference Manual 1 System Setup 19
Symbols on the Product or Packaging 1 Calibration 20
On-Line Operation 21
List of Figures 7
Summary of System Setup, Calibration, and
Introduction 9 Operation 23
Indications for Use 9 Interpretation of Results 24
Contraindications 9 Oxygen Saturation Results 24
Cautions 10 Hematocrit Results 24

Warnings 10 Offset Adjustment 25

Hct Correlation 25
Features and Controls 11
SO2 Correlation 26
Special Features 11
Functional Controls 13 Alarms and Warnings 27
Other Design Features 13 Cleaning and Maintenance 28
Theory of Operation 15 General 28
Cleaning 28
Setup and Operation 16
Maintenance 28
Operating Notes 16

Operator and Reference Manual 5

85652 Rev 3.0

 BIOENM1.TOC 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 6 Friday, July 2, 2004 12:43 PM

Voltage Identification 29 Warranty 38

Batteries 29 Disclaimer of Warranty - US Customers 40
Battery Replacement 29
Limited Warranty - Customers Outside US 41
Technical Specifications 30 Medtronic® BioTrend® Instrument Limited
Warranty 41
Order Information 31
Disclaimer of Warranty - Customers Outside US 43
Troubleshooting Guide 32

Instrument Inspection 34
Visual Inspection 34
Functional Inspection 34

Digital Output 35
Connecting to the Data Acquisition Device 35
Output Format 36
Interface Format 37
Mode Settings 37
Pin Definition 37

Limited Warranty - US Customers 38

Medtronic® BioTrend® Instrument Limited

6 Operator and Reference Manual

85652 Rev 3.0

 BIOENM1.LOF 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 7 Friday, July 2, 2004 12:43 PM

List of Figures

Figure 1. Front Display Panel 12

Figure 2. Rear and Side View 14
Figure 3. Cable Connections 18
Figure 4. Tri-optic Measurement Cell (TMC) and Sensor
Cable 22

Operator and Reference Manual 7

85652 Rev 3.0

 BIOENM1.LOF 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 8 Friday, July 2, 2004 12:43 PM

8 Operator and Reference Manual

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 9 Friday, July 2, 2004 12:43 PM

Introduction battery pack to provide the battery power. Consequently,

the BioTrend instrument can be operated on AC or battery
The BioTrend® Oxygen Saturation and Hematocrit System power.
is an on-line monitoring instrument that combines both A continuous, built-in self-check immediately alerts the
venous (SvO2) and arterial (SaO2) oxygen saturation operator of equipment failure and displays a corresponding
measurement with hematocrit (Hct) measurement. error code.
Using fiber-optic technology, the BioTrend system
continuously measures percent oxygen saturation and Indications for Use
hematocrit and displays the results on large, easy-to-read, The BioTrend system measures percent oxygen saturation
color-coded Liquid Crystal Displays (LCDs). The display and hematocrit of the blood in the extracorporeal circuit.
panel indicates operating status and error messages, and The extracorporeal circuit is used for, but is not limited to,
provides a means for system calibration. cardiopulmonary bypass, closed-chest support, and limb
BioTrend Sensor Cables connect to the BioTrend instrument perfusion.
and the in-line Tri-optic Measurement Cells (TMC) to
transmit optical measurement signals. The TMC is the Contraindications
disposable device in the extracorporeal circuit that provides The BioTrend system is not intended to substitute for
a sealed interface between the blood pathway and the regular patient observation and laboratory testing. Prior to
BioTrend sensor cable. Refer to “System Setup” on page 19 any therapeutic treatment, the oxygen saturation and
and “On-Line Operation” on page 21 for further hematocrit should be determined by laboratory methods.
information regarding the TMC. The BioTrend system has not been tested for Magnetic
The BioTrend sensor cables isolate the patient from the Resonance Imaging (MRI) compatibility and should not be
instrument electronics, providing patient protection. The used in that environment.
BioTrend instrument contains a built-in, rechargeable

Operator and Reference Manual 9

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 10 Friday, July 2, 2004 12:43 PM

Cautions Warnings
The BioTrend system is an on-line monitoring instrument, Read all Warnings, Precautions, and Instructions for Use
not intended to substitute for regular patient observation carefully prior to use. Failure to read and follow all
and laboratory testing. Prior to any therapeutic treatment, instructions, or failure to observe all stated warnings,
the oxygen saturation and hematocrit should be could cause serious injury or death to the patient.
determined by laboratory methods.
Possible explosion hazard—do not use in the presence of
An electrical shock hazard exists when the instrument flammable anesthetics or other explosive gases.
housing is open. Refer servicing to a qualified Medtronic
service representative. Do not autoclave, sterilize, or submerge the instrument in a
liquid.
Cautions:
Federal (USA) law restricts this device to sale by or on Do not autoclave, sterilize, or submerge the sensor cables in
the order of a physician. a liquid.
Oxygen saturation levels are known to be affected by Do not autoclave or resterilize a Tri-optic Measurement Cell
fetal hemoglobin. The effect of fetal hemoglobin on the (TMC). Do not reuse a TMC.
BioTrend system has not been quantified. Do not kink sensor cables.
Do not touch the optical interfaces of the instrument, sensor
cables, or TMC.
Do not drop the instrument.
Do not place any object on this instrument.
Do not attempt any repair of the instrument.

10 Operator and Reference Manual

10

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 11 Friday, July 2, 2004 12:43 PM

Features and Controls Battery Charging — With the power switch in the “On” or
“Off/Standby” position, the BioTrend instrument
Special Features automatically recharges the internal battery whenever it is
plugged into an AC power source.
(Refer to Figure 1 and Figure 2.)
AC or Battery — During operation the instrument will
Display — Large, color-coded liquid crystal display (LCD). automatically switch to battery power when disconnected
■ Oxygen Saturation Venous Value (SvO2) -Blue from an AC power source.
■ Hematocrit Value (Hct) - White
■ Oxygen Saturation Arterial Value (SaO2) - Red
■ Battery, AC - Green
■ Low Battery - Red Border
Self-Test — Automatically tests instrument functions
when instrument is turned on.
Cal — Operator initiated, self-contained calibration of
system.

Operator and Reference Manual 11

11

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 12 Friday, July 2, 2004 12:43 PM

1 2 3 10 4 5 11

Hct SaO2 6
SvO2 STORE

RECALL 7

CAL
8

1. SvO2 (Venous Display) 6. STORE Button

2. Hct (Hematocrit Display) 7. RECALL Button
3. SaO2 (Arterial Display) 8. CAL (Calibration) Button
4. Battery Charging Condition 9. AC Power Indicator
5. Up/Down Arrows 10. Low Battery Warning
11. Store Illuminator

Figure 1. Front Display Panel

12 Operator and Reference Manual

12

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 13 Friday, July 2, 2004 12:43 PM

Functional Controls Other Design Features

On/Standby Switch — Located on the right rear corner of Sealed Touch Sensitive Buttons — These buttons, located
the BioTrend instrument, this switch controls power to the on the front display panel, are splash proof against possible
instrument. Switch to the “ON” position to operate the fluid intrusion, easy to clean, and provide protection to
instrument. The instrument will automatically operate in interior electronics.
either AC or battery mode, with default to the AC power
Easy Access to Batteries — A convenient door located on
when attached to an AC power source. The “STANDBY”
the bottom of the BioTrend instrument allows easy access to
position of the switch provides power to the battery
remove and replace the rechargeable batteries. Removing
charger. The battery will be charging at all times when the
the battery access door does not expose the electronics.
instrument is connected to AC power.
Integrated Pole Clamp — The pole clamp fits poles from
Note: The International Power Switch Symbols are:
1.91 cm to 5.08 cm (0.75 in to 2.0 in) in diameter.
= “On” Only for a Part of Equipment
= “Off/Standby” Only for a Part of Equipment Power Cord — The BioTrend instrument includes a
hospital-grade, detachable power cord that locks securely
CAL Button — Used to activate the system calibration
to the instrument.
during instrument setup.
STORE Button — Stores SvO2 , Hct, and SaO2 captured
values for later retrieval.
RECALL Button — Recalls individual stored values.
▲ Arrows — Used to adjust stored values to
▼ Up/Down
match lab reference results.

Operator and Reference Manual 13

13

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 14 Friday, July 2, 2004 12:43 PM

8
3

1
7
6
4 5
2

1. Instrument Arterial Connector 5. On/Standby Switch

(Venous Connector on opposite side) 6. Pole Clamp Jaws
2. Calibration Port Locking Tabs 7. Electrical Power Cord
(both sides of instrument)
8. Communication Port
3. Calibration Port
(both sides of instrument) 9. Dust Cap
(both sides of instrument)
4. Pole Clamp Knob

Figure 2. Rear and Side View

14 Operator and Reference Manual

14

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 15 Friday, July 2, 2004 12:43 PM

Theory of Operation compensates for this effect in the calculation of oxygen

saturation. Therefore, the oxygen saturation equation
It has been established that blood oxygen saturation and contains a hematocrit value to increase the accuracy of the
hematocrit can be measured using dual wavelength light oxygen saturation value.
reflectance techniques. The BioTrend system uses
light-emitting diodes (LEDs) to generate the wavelengths % Oxygen Saturation = Function (KV, RATIO, HCT)
required for these measurements. The light is transmitted KV is a calibration factor
via the fiber-optic cables through the TMC wall to the RATIO is the ratio of IR/R
blood. The light is reflected by the blood, generating an HCT is the hematocrit value
optical signal proportional to the percent of oxygen IR is the reflected infrared light wavelength signal
saturation and hematocrit. The reflected signal is returned R is the reflected visible red light wavelength signal
to the instrument by the same fiber-optic cable. This signal
is then converted to an electrical signal by a photosensitive
transistor. To further improve the accuracy and Hematocrit is measured using reflected infrared light from
repeatability of the system, the reflected signal level of each formed particles in the blood. The reflected infrared light
light source has a calibration factor determined during will be proportional to the percent of red cells in the blood.
calibration. These resulting calibration factors are used to
correct each reflected signal prior to calculating oxygen % Hematocrit = Function (IR)
saturation and hematocrit.
Oxygen saturation accuracy has been shown to have a The light source is preset to an intensity that is maintained
dependency on the hematocrit.1 The BioTrend system by a servo control circuit in the BioTrend instrument. The
1 ambient light level at the TMC is monitored and subtracted
Schmitt JM, Mihm FG, Meindl JD. New methods for whole blood oximetry.
Ann Biomed Eng. 1986;14:35-52. from these signals.

Operator and Reference Manual 15

15

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 16 Friday, July 2, 2004 12:43 PM

Setup and Operation Operating Notes

1. Visually inspect the BioTrend instrument and sensor
Important: Each BioTrend system has been fully tested cable(s) for external signs of damage or wear before
prior to shipment and should be used only in accordance operation. The sensor cables can be used
with the procedures detailed in this manual. interchangeably on either the venous or arterial side of
The BioTrend instrument must be used with Medtronic Tri- the instrument.
optic Measurement Cell(s) (TMC) only. 2. Inspect TMC(s) sterile packaging before opening. If the
Any substitution will void performance claims and sterile seal has been broken, DO NOT USE.
warranty. Follow labeling on TMC package.
3. The instrument should not be operated on battery power
until it has been plugged into an AC outlet and allowed
to charge for 24 hours.
4. Users must read and understand this manual completely
before operating the BioTrend system.

16 Operator and Reference Manual

16

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 17 Friday, July 2, 2004 12:43 PM

Instrument Setup
1. Mount the BioTrend instrument on a sturdy intravenous
(IV) pole or pump console pole, using the integral pole
clamp feature. (The BioTrend instrument may also be
placed on a sturdy table or stand.)

2. AC Operation (refer to Figure 3):

Connect the power cord to the BioTrend instrument AC

power receptacle located on the rear of the instrument.
Connect the power cord to a grounded hospital grade
outlet.
Note: Ensure that the outlet used is appropriate for your
BioTrend instrument (see “Voltage Identification” on
page 29).

3. Battery Operation:

The BioTrend instrument should be connected to a

grounded AC power source for 24 hours prior to
operation on battery to obtain maximum battery life.

Operator and Reference Manual 17

17

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 18 Friday, July 2, 2004 12:43 PM

3 8
9
1. Keyed Sensor Cable Connector
2. Sensor Cable Base 5
3. Wide Locking Tab of 6
7
Calibration Port 2
4. Wide Slot of Sensor
Cable Base
4
5. Sensor Cable Knob
6. BioTrend® Sensor Cable
7. Dust Caps
8. AC Power Receptacle
9. Electrical Power Cord

Figure 3. Cable Connections

18 Operator and Reference Manual

18

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 19 Friday, July 2, 2004 12:43 PM

Instrument Self-Test System Setup

When the “ON/STANDBY” switch is turned to “ON,” the 1. Turn on the BioTrend instrument for a 20-minute warm-
BioTrend instrument will automatically go through a up period (note display as indicated in Self-Test section).
sequence of diagnostic tests to determine the operational 2. Place one or two TMC(s) into the extracorporeal circuit
capabilities. using sterile technique. The venous TMC should be
Caution: placed in the venous line before the oxygenator and the
The operator should observe that all regions and arterial TMC should be placed in the arterial line after
segments of the display are illuminated during the the oxygenator. The TMC should be installed into the
power-up period. If all regions and segments do not extracorporeal circuit prior to priming.
illuminate, call your Medtronic service representative Note: The TMC is provided with a protective label over
for assistance. the optical window. This label is to protect the TMC
window during installation into the extracorporeal
When the self-test is completed, the word “CAL” and the circuit and should be removed prior to the TMC being
software’s EPROM revision (in this case, 1.13) will appear connected to the BioTrend sensor cable.
on the front panel display as follows: 3. Remove the dust caps from the BioTrend instrument
cable connection port(s) and the BioTrend sensor cable(s)
C A L 1 1 3 connector.
4. Attach the cable to the instrument by placing the end of
This indicates that the operator may proceed. the sensor cable over the instrument connector and
rotating the sensor cable end clockwise until secure.
Note: The connection is keyed for proper alignment
(refer to Figure 3).

Operator and Reference Manual 19

19

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 20 Friday, July 2, 2004 12:43 PM

Calibration 3. Press the [CAL] button and hold down for approximately
5 seconds. The display message will read:
Notes:
The system calibration must be performed every time a
set-up is initiated. To perform subsequent calibrations, C A L
the instrument must be turned off, then back on.
When using two BioTrend sensor cables, they must be This indicates calibration is in process.
calibrated simultaneously.
Do not kink or disturb the BioTrend sensor cables during 4. When the calibration is completed (using both sensor
calibration. cables) the display message will become:
1. Connect the BioTrend sensor cable(s) to the SvO2 Hct SaO2
CAL PORT(s) on the BioTrend instrument (Figure 3).
00 00 00
Align the slots on the sensor cable connector to the
locking tabs on the CAL PORT and depress and rotate Note: If only one VENOUS or ARTERIAL sensor cable is
the connector knob clockwise until it locks into position. being used or if one sensor cable fails to calibrate, the
display message for that channel will become blank:
Note: The tabs and slots are keyed for proper alignment.
(example using only the venous sensor cable).
2. The display message will read:
SvO2 Hct SaO2
00 00 “blank”
C A L 1 1 3

20 Operator and Reference Manual

20

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 21 Friday, July 2, 2004 12:43 PM

Note: If both VENOUS and ARTERIAL channels fail to On-Line Operation

calibrate, the display message will return to: 1. Remove the protective label from the TMC(s). Ensure
that the cell window is free from defects and smudges.
C A L 1 1 3 Replace the TMC if the cell window has defects. Clean the cell
window with a nonabrasive cloth if smudges are
Refer to the “Troubleshooting Guide” on page 32 of this present.
manual for correction and possible cause of sensor cable 2. Connect venous sensor cable to the TMC in the venous
calibration problems. line, and connect the arterial sensor cable to the TMC in
5. The BioTrend® instrument will automatically enter the the arterial line. Align the slots on the sensor cable to the
run mode at the end of the calibration mode. The locking tabs on the TMC and rotate the connector knob
displayed message will become dashed lines when until it locks into position. Note that the tabs and slots
entering the run mode: are keyed for proper alignment and the instrument is
labeled as to venous and arterial connection ports (refer
SvO2 Hct SaO2
to Figure 4.)
–– –– ––
Caution: The system will operate effectively with only
Note: Dashed lines will continue to be displayed until one TMC connected, but the dust cap for the
the sensor cable(s) is connected to the extracorporeal unconnected cable must be in place, either on the
circuit, and blood is present in the circuit. instrument (if no sensor cable is attached) or on the end
6. Disconnect the sensor cable(s) from the CAL PORT(s) by of the idle sensor cable (if it is attached to the
turning the sensor cable knob counterclockwise until instrument).
disengaged. If numbers are displayed on the unconnected saturation
Note: If cables are disconnected from the instrument display, check dust cap(s) for proper attachment.
connector, they must be recalibrated prior to use.

Operator and Reference Manual 21

21

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 22 Friday, July 2, 2004 12:43 PM

Warning: Do not kink sensor cables. 3. After initiation of blood flow, allow the oxygen
saturation and hematocrit readings to stabilize for 30
seconds.

1 Note: The display may show dashed lines until blood is

flowing in the extracorporeal circuit.
5 Caution: Invalid values may be displayed until blood
and priming fluid are homogenous.
4 2

1. Tri-optic Measurement Cell (TMC)

2. Sensor Cable Base
3. Wide Locking Tab of TMC
4. Wide Slot of Sensor Cable Base
5. Sensor Cable Knob

Figure 4. Tri-optic Measurement Cell (TMC) and Sensor Cable

22 Operator and Reference Manual

22

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 23 Friday, July 2, 2004 12:43 PM

Summary of System Setup, Calibration, and Operation

1. Turn on the instrument and allow for a 20-minute
warm-up period.
2. Remove dust caps from all sensor connections to be
used.
3. Insert TMC(s) into circuit.
4. Attach Cable to instrument.
5. Calibrate instrument:
a. Connect Cable(s) to CAL PORT(s).
b. Press [CAL] button and hold for approximately
5 seconds.
c. Remove Cable(s) from CAL PORT(s).
6. Remove protective label(s) from TMC(s).
7. Connect Cable(s) to TMC(s) in the circuit.
8. Allow readings to stabilize for 30 seconds after the start
of blood flow.

Operator and Reference Manual 23

23

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 24 Friday, July 2, 2004 12:43 PM

Interpretation of Results Hematocrit Results

When initiating an extracorporeal support circuit
The BioTrend system is an on-line monitoring instrument hemodilution occurs, decreasing the percent of hematocrit.
and not intended to substitute for regular patient This decrease in hematocrit will be proportional to the
observation and laboratory testing. Prior to any therapeutic dilution ratio of the blood.
treatment, the oxygen saturation and hematocrit should be
determined by laboratory methods. Caution: Prior to blood transfusion or other therapeutic
treatments, the hematocrit should be determined by
The BioTrend system performance ranges at nominal laboratory methods.
physiological conditions:
Notes:
Oxygen Saturation 40% to 99% The percent of hematocrit should not decrease below
Hematocrit 16% to 38% accepted standards established by your institution.
Note: When the instrument reaches the range limits, the Hct display values will flash at 12%, 13%, 14%, 15%,
display will flash these values. 16%, 38%, 39%, and 40%.
When the Hct range limits of 12% and 40% are exceeded,
Oxygen Saturation Results the front panel displays will indicate dashes:
Note: The SaO2 and SvO2 display values on the BioTrend SvO2 Hct SaO2
instrument will hold and flash at the range limits of 99% –– –– ––
and 40% when oxygen saturation reaches or exceeds
these limits.

24 Operator and Reference Manual

24

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 25 Friday, July 2, 2004 12:43 PM

Offset Adjustment 4. SvO2, SaO2, and Hct remain active displaying current
values.
Users should read and understand the Hct and SO2 correlation 5. Receive sample results from lab.
(described in this section) completely before utilizing as this
feature is timed to button activity.
Hct Correlation
Note: This is an optional feature. The BioTrend
instrument allows the user to adjust none, one, or all of 6. Depress the [RECALL] button one time to retrieve stored
the displayed values. Normal operation of the BioTrend Hct value.
instrument is not dependent on using this feature. 7. Both SO2 displays will blank, leaving only the Hct
Note: If you choose to use the offset feature, it is display visible.
recommended that more than one lab sample be 8. Depress [UP ARROW] button to increment display or
considered when an adjustment is made. depress [DOWN ARROW] button to decrement display in
order to match lab reference result.
1. Initiate normal calibration procedure as described in the
calibration section of Setup and Operation.
2. BioTrend system enters normal run mode.
3. Depress the [STORE] button at the same time the sample
is drawn and sent to lab. This action stores all presently
displayed values.
Note: The “Store” indicator light will illuminate
providing indication that a value has been stored.

Operator and Reference Manual 25

25

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 26 Friday, July 2, 2004 12:43 PM

SO2 Correlation
9. Depress the [RECALL] button again. The Hct display and
SaO2 display will become blank, leaving only the
previously stored SvO2 value visible. The perfusionist
can now increment or decrement this value. If the recall
button is depressed a third time, the SvO2 and Hct
displays will become blank, leaving only the SaO2
recalled value visible. This SaO2 value can now be
adjusted.

Important: After approximately 15 seconds of no

(button) activity, the BioTrend instrument returns to run
mode and the “Store” light goes off. Values previously
stored when the sample was sent to the lab will no
longer be available. Any adjustments made will be
captured as the instrument returns to the run mode.
Note: If there is no arterial (SaO2) side cable attached,
depressing the recall button will only cycle between the
Hct and SvO2 displays. Conversely, if there is no venous
(SvO2) side cable attached, depressing the recall button
will only cycle between the Hct and SaO2 displays.

26 Operator and Reference Manual

26

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 27 Friday, July 2, 2004 12:43 PM

Alarms and Warnings Error Codes — An error is indicated when the system
detects an abnormal function, which may compromise the
The alarms in the BioTrend instrument are visually measured results. In these cases an alphanumeric error
displayed messages. The messages are presented when message will be shown in the display area.
conditions are detected that may affect the operation of the
Note: Record this alphanumeric error message and
instrument.
contact your Medtronic service representative.
Low Battery — Indicates that the battery power is nearly
Warning: The instrument must be returned for repair
depleted and approximately 30 minutes remain before the
when one of these error messages occurs. DO NOT
system will stop operation. The actual time remaining will
attempt any repair of the instrument.
depend on the condition and age of the batteries. Returning
the unit to AC operation will discontinue the warning and Warning: Should the BioTrend instrument be dropped
recharge the batteries. or otherwise damaged, it is important to contact your
Medtronic service representative immediately to return
Note: When the low battery alarm is activated, a red
the instrument for service.
border will be visible around the battery icon on the
front panel display.

Operator and Reference Manual 27

27

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 28 Friday, July 2, 2004 12:43 PM

Cleaning and Maintenance ■ Do not use alcohol on the sensor cable ends (where
the fiber ends are exposed).
General Warning: Do not sterilize the instrument or immerse it
Periodic maintenance is recommended to ensure accurate in fluids.
performance and reliability.
Note: Service on the BioTrend instrument, except for
battery recharging or replacement, should be referred to Maintenance
qualified Medtronic service personnel. Refer to the All maintenance or service should be performed by a
manual for instructions regarding battery replacement. qualified Medtronic service representative. Contact your
local Medtronic representative for assistance.
Cleaning
Note: The dust covers should be kept attached to the
The BioTrend instrument is designed to be spill resistant. If instrument connectors and sensor cable ends when not
a spill should occur, wipe off the instrument as soon as in use.
possible using a damp cloth or sponge. Use water or a mild
disinfecting detergent not containing cleaning chemicals Important: When returning the BioTrend instrument for
for cleaning (see cautions below). Wipe dry. repair to the factory, the sensor cables must be included
to ensure proper diagnosis and repair.
Cautions:
■ Do not use cleaning chemicals, such as acetone,
benzene, bleach, chlorine, or alcoholic disinfectants
for hands, as they may damage the unit.

28 Operator and Reference Manual

28

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 29 Friday, July 2, 2004 12:43 PM

Voltage Identification Battery Replacement

The BioTrend instrument is made to operate on The BioTrend instrument is designed to allow the operator
100/120 VAC or 220/ 230/ 240 VAC at 50 Hz to 60 Hz. to replace the battery pack. To replace the battery pack:
Refer to the voltage identification label located on the 1. Turn the power off and disconnect from the AC power
bottom of the BioTrend instrument for your unit’s source.
designated operating voltage.
2. Remove the battery by opening the battery door on the
Caution: An electrical shock hazard exists when the bottom of the instrument, disconnecting the battery pack
BioTrend instrument housing is opened. connector.
3. Install the new battery pack and connect to the battery
Batteries pack connector.
The BioTrend instrument contains a nickel-cadmium 4. Replace battery door.
rechargeable battery pack. The battery pack is
5. Plug the instrument into an AC power source and allow
automatically recharged when the instrument is connected
it to charge for 24 hours prior to use.
to an AC power source.
Note: Dispose of old batteries per Country, State,
In the event of reduced battery life, longevity may be
and/or local requirements.
improved by completely discharging and recharging the
instrument several times. If battery replacement is required, Caution: Batteries should be removed from the
contact your local Medtronic representative to obtain BioTrend instrument if it is not likely to be used for an
appropriate replacement batteries. extended period of time.

Operator and Reference Manual 29

29

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 30 Friday, July 2, 2004 12:43 PM

Technical Specifications

Oxygen Saturation Range: 40% to 99% Vertical Pole Mount: Accommodates pole diameter:
Hematocrit Operating Range: 16% to 38% 1.91 cm to 5.08 cm
(0.75 in to 2.0 in)
Display Update: 12 seconds
Weight: 5.9 kg (13 lb)
Power: 100/120 VAC 50 Hz to 60 Hz, 13.2 W, 110 mA
220/230/240 VAC 50 Hz to 60 Hz, 13.2 W, 71 mA Size: Width x Height x Depth
24.77 cm x 9.22 cm x 27.94 cm
Power 100/120 VAC Length: 3 m (9.8 ft)
(9.75 in x 3.63 in x 11.00 in)
Cords: 220/230/240 VAC Length: 2.5 m (8.2 ft)
Environmental Limits:
Battery Life: 6 hours
Operating Temperature 18°C to 33°C (64°F to 92°F)
Batteries: Rechargeable nickel-cadmium Storage Temperature -35°C to 66°C (-31°F to 150°F)
battery pack Operating Humidity 30% to 75%, noncondensing
Storage Humidity 30% to 75%, noncondensing
Battery Recharge: 24 hours to completely recharge Storage Pressure 73 kPa to 101 kPa
when connected to an AC power
source Classification (IEC 601): Class I or internally powered
Type BF
Standards Safety: IEC 601-1 Type BF
Splash proof
Standards EMC: IEC 601-1-2
Intermittent operation
Not anesthetic proof

30 Operator and Reference Manual

30

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 31 Friday, July 2, 2004 12:43 PM

Order Information
Contact your customer service representative for ordering
information.

Operator and Reference Manual 31

31

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 32 Friday, July 2, 2004 12:43 PM

Troubleshooting Guide
Note: When returning the BioTrend instrument for
repair to the factory, sensor cables must be included to
ensure proper diagnosis and repair.

Problem Cause Correction

Display not illuminated. Instrument power not turned Turn power switch (located on back of instrument) to “ON”
on. position.

Instrument turned “ON,” but Instrument battery supply is Plug power cord into AC outlet and charge the batteries.
display is not illuminated. discharged.

Instrument will not calibrate. Calibration signal is outside of 1. Check connections of sensor cable.
acceptable limits. 2. Hold one end of the sensor cable towards light, observe other
end of cable for light transmission through all fibers.
3. Change or remount the cable and attempt calibration again.
4. Contact your Medtronic service representative.

32 Operator and Reference Manual

32

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 33 Friday, July 2, 2004 12:43 PM

Problem Cause Correction

Display shows “E- _ _” in value Internal instrument failure. Return the instrument to Medtronic, Inc. for repair. Contact your
windows. Medtronic service representative.

“Low Battery” warning Internal battery charge is Plug power cord into hospital-grade outlet.
message. depleted.

Note: In all events, should the suggested correction not

prove effective, contact your Medtronic service
representative for assistance.

Operator and Reference Manual 33

33

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 34 Friday, July 2, 2004 12:43 PM

Instrument Inspection ■ Mechanical damage to the device, accessories, and all

cables and connectors.
This section provides a list of inspection checks on the
BioTrend instrument for technical personnel trained and
skilled in all device functions. Users must read and Functional Inspection
understand this manual completely before operating the ■ Self-test (see Operator and Reference Manual).
BioTrend system and performing these checks. Operating
functions of this device should be checked prior to use as Electrical safety in accordance with IEC 601-1.
stated in this manual. Device instrument inspection, as
described in this section, should be checked at least once
Protective earth resistance < 0.2 Ω
every 12 months. maximum1:
Where the integrity of the external protective earth
Earth leakage current 0.1 mA
conductor arrangement is in doubt, the equipment shall be maximum2:
operated from its internal electrical power source.
Enclosure leakage current 0.1 mA
In all events, should problems occur, contact your maximum:
Medtronic service representative.
Patient leakage current 0.1 mA
Visual Inspection maximum:

■ Operator and Reference Manual. 1Impedance between protective earth terminal of power supply cord and
■ Inscriptions, information, and warning signs properly any accessible metal part.
and completely fixed. 2Manufacturer’s specification for the BioTrend instrument’s maximum earth

leakage current is 0.1 mA. The IEC 601-1 specification is 0.5 mA maximum.

34 Operator and Reference Manual

34

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 35 Friday, July 2, 2004 12:43 PM

Digital Output Notes: Connecting the BioTrend instrument to a data

acquisition device can be done prior to or after
This section describes how to access the communication calibration of the instrument.
port (RS-232) to send digital output to a printer, computer,
or other data acquisition devices. It also describes the The printer or computer data acquisition device
format of the data available to the user. attached to the communication port must comply with
IEC 950.
The communication port allows the user to send hematocrit
and oxygen saturation readings to a data acquisition device Connecting to the Data Acquisition Device
when the BioTrend instrument is operating on either AC or
1. Obtain a BioTrend Communication Port Cable.
battery power.
2. Attach and secure the ends of the communication port
Notes: Accurate digital output readings are dependent cable to the instrument and data acquisition device.
on the BioTrend instrument being calibrated and
operating in the run mode with the TMC(s) connected as Note: Align to match 9-pin connector.
described in the Setup and Operation section of this 3. Operate instrument. Readings will be sent to the data
manual. acquisition device every 12 seconds.

A BioTrend Communication Port Cable is needed to

connect from the BioTrend instrument to a data
acquisition device. To obtain this cable, contact your
Medtronic service representative.

Operator and Reference Manual 35

35

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 36 Friday, July 2, 2004 12:43 PM

Output Format Note: If the self-tests do not pass, the front panel display
will show an error message “E _ _“ in the value
Upon initial power up of the BioTrend instrument, the
windows. Record this number and contact your
digital output will present a message to let you know the
Medtronic service representative.
software’s EPROM revision (for example, 1.13), as well as
the type of power the instrument is using, and a message
that the system tested successfully.
The BioTrend insturment will then send digital output to
the data acquisition device that shows oxygen saturation
Message example - operating on AC power: and hematocrit readings for both arterial (ART) and venous
MEDTRONIC BIOTREND (VEN) parameters when both lines have TMC(s) installed in
the circuit. Digital output will also be sent if only one TMC
Ver 1.13
is connected to the circuit.
AC Power on
All Tests OK The format of the digital output appears similar to that displayed
in the following sample table (shown with both arterial and
venous TMC(s) installed).
Message example - operating on battery power
MEDTRONIC BIOTREND
Ver 1.13 VEN: SO2 = 75 HCT = 24 ART: SO2 = 95 HCT = 24
Batt Voltage = 11.0 (Voltage readings vary) VEN: SO2 = 75 HCT = 24 ART: SO2 = 95 HCT = 24
All Tests OK VEN: SO2 = 76 HCT = 25 ART: SO2 = 96 HCT = 25

36 Operator and Reference Manual

36

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 37 Friday, July 2, 2004 12:43 PM

Interface Format
Communication Port conforms to RS-232 standards.

Mode Settings
Parameter Setting
Baud Rate 9600
Parity None
Number of Data Bits 8
Number of Stop Bits 1

Pin Definition
Pin Function
2 Receive data
3 Transmit data
5 Signal ground
6 Data set ready (DSR) -
internally connected to +12 V
8 Clear to send (CTS) -
internally connected to +12 V
Other Not connected

Operator and Reference Manual 37

37

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 38 Friday, July 2, 2004 12:43 PM

Limited Warranty - US Customers provide a functionally comparable replacement

BioTrend at no charge.
Medtronic® BioTrend® Instrument Limited Warranty (2) As used herein, Purchase Price shall mean the lesser
(This Limited Warranty applies only to products sold within the of the net invoiced price of the original, or current
United States of America.) functionally comparable, or replacement BioTrend®.

A. This Limited Warranty1 provides the following B. To qualify for the repair, replacement, or credit set forth
assurance to the purchaser of the BioTrend instrument, in Section A, the following conditions must be met:
hereafter referred to as the “BioTrend”: (1) The BioTrend must be returned to Medtronic within
(1) Should the BioTrend, excluding batteries and sensor 15 days after discovery of the defect, (Medtronic may,
cables, fail to function within normal tolerances due at its option, repair the BioTrend on site).
to a defect in materials or workmanship within a (2) The BioTrend must not have been repaired or altered
period of 1-year, commencing with the delivery of the outside of Medtronic’s factory in any way which, in
BioTrend to the purchaser, Medtronic will at its the judgement of Medtronic, affects its stability and
option: (a) repair or replace any part or parts of the reliability. The BioTrend must not have been
BioTrend; subjected to misuse, abuse or accident.
(b) issue a credit to the purchaser equal to the
Purchase Price, as defined in Subsection A(2), against C. This Limited Warranty is limited to its express terms. In
the purchase of the replacement BioTrend or (c) particular:

1
(1) Except as expressly provided by this Limited
This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic
Parkway, Minneapolis, MN 55432-5604. It applies only in the United States.
Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR
Areas outside the United States should contact their local Medtronic ANY DIRECT, INCIDENTAL OR
representative for exact terms of the Limited Warranty. CONSEQUENTIAL DAMAGES BASED ON ANY
DEFECT, FAILURE OR MALFUNCTION OF THE

38 Operator and Reference Manual

38

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 39 Friday, July 2, 2004 12:43 PM

BIOTREND, WHETHER THE CLAIM IS BASED ON shall be construed and enforced as if this Limited
WARRANTY, CONTRACT, TORT OR OTHERWISE. Warranty did not contain the particular part or term
held to be invalid. This Limited Warranty gives the
(2) This Limited Warranty is made only to the purchaser
purchaser specific legal rights. The purchaser may
of the BioTrend. AS TO ALL OTHERS, MEDTRONIC
also have other rights which vary from state to state.
MAKES NO WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY (4) No person has any authority to bind Medtronic to
IMPLIED WARRANTY OF MERCHANTABILITY, any representation, condition or warranty except this
OR FITNESS FOR A PARTICULAR PURPOSE Limited Warranty.
WHETHER ARISING FROM STATUTE, COMMON
LAW, CUSTOM OR OTHERWISE. NO EXPRESS OR
IMPLIED WARRANTY TO THE PATIENT SHALL
EXTEND BEYOND THE PERIOD SPECIFIED IN
A(1) ABOVE. THIS LIMITED WARRANTY SHALL
BE THE EXCLUSIVE REMEDY AVAILABLE TO
ANY PERSON.
(3) The exclusions and limitations set out above are not
intended to, and should not be construed so as to
contravene mandatory provisions of applicable law.
If any part or term of this Limited Warranty is held to
be illegal, unenforceable or in conflict with applicable
law by a court of competent jurisdiction, the validity
of the remaining portions of the Limited Warranty
shall not be affected, and all rights and obligations

Operator and Reference Manual 39

39

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 40 Friday, July 2, 2004 12:43 PM

Disclaimer of Warranty - US Customers TO ANY REPRESENTATION OR WARRANTY WITH

RESPECT TO THE ACCESSORIES.
(This Disclaimer of Warranty applies only to products sold within
the United States of America.) The exclusions and limitations set out above are not
intended to, and should not be construed so as to
ALTHOUGH THE BIOTREND TRI-OPTIC
contravene mandatory provisions of applicable law. If any
MEASUREMENT CELL AND THE BIO-TREND SENSOR
part or term of this Disclaimer of Warranty is held to be
CABLE, HEREAFTER REFERRED TO AS ACCESSORIES,
illegal, unenforceable or in conflict with applicable law by a
HAVE BEEN MANUFACTURED UNDER CAREFULLY
court of competent jurisdiction, the validity of the
CONTROLLED CONDITIONS, MEDTRONIC HAS NO
remaining portions of this Disclaimer of Warranty shall not
CONTROL OVER THE CONDITIONS UNDER WHICH
be affected, and all rights and obligations shall be construed
THESE ACCESSORIES ARE USED. MEDTRONIC,
and enforced as if this Disclaimer of Warranty did not
THEREFORE DISCLAIMS ALL WARRANTIES, BOTH
contain the particular part or term held to be invalid.
EXPRESS AND IMPLIED, WITH RESPECT TO THE
ACCESSORIES, INCLUDING, BUT NOT LIMITED TO,
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC
SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY
FOR ANY MEDICAL EXPENSES OR ANY DIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES
CAUSED BY ANY USE, DEFECT, FAILURE, OR
MALFUNCTION OF THE ACCESSORIES, WHETHER A
CLAIM FOR SUCH DAMAGES IS BASED UPON
WARRANTY, CONTRACT, TORT OR OTHERWISE. NO
PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC

40 Operator and Reference Manual

40

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 41 Friday, July 2, 2004 12:43 PM

Limited Warranty - Customers Outside US B. To qualify for this repair, replacement or credit, the
following conditions must be met:
Medtronic® BioTrend® Instrument Limited Warranty (1) The BioTrend must be returned to Medtronic within
(This Limited Warranty applies only to products sold outside the sixty (60) days after discovery of the defect,
United States of America.) (Medtronic may, at its option, repair the BioTrend on
site).
A. This LIMITED WARRANTY1 provides the following
assurance to the purchaser of the BioTrend instrument, (2) The BioTrend must not have been repaired or altered
hereafter referred to as the “BioTrend” that should the by someone other than Medtronic in any way which,
BioTrend, excluding batteries and sensor cables, fail to in the judgement of Medtronic, affects it’s stability
function within normal tolerances due to a defect in and reliability.
materials or workmanship within a period of 1 year, (3) The BioTrend must not have been subjected to
commencing with the delivery of the BioTrend to the misuse, abuse or accident.
purchaser, Medtronic will at its option: (a) repair or
replace any defective part or parts of the BioTrend; C. This LIMITED WARRANTY is limited to its express
(b) issue a credit equal to the original BioTrend purchase terms. In particular, Medtronic is not responsible for any
price (but not to exceed the value of the replacement incidental or consequential damages based on any use,
BioTrend), against the purchase of the replacement defect or failure of the BioTrend, whether the claim is
BioTrend or (c) provide a functionally comparable based on warranty, contract, tort or otherwise.
replacement BioTrend at no charge. D. The exclusions and limitations set out above are not
intended to, and should not be construed so as to,
1 This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic contravene mandatory provisions of applicable law. If
Parkway, Minneapolis, MN 55432-5604. It applies only outside the United
any part or term of this LIMITED WARRANTY is held
States.
by any court of competent jurisdiction to be illegal,

Operator and Reference Manual 41

41

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 42 Friday, July 2, 2004 12:43 PM

unenforceable or in conflict with applicable law, the

validity of the remaining portion of the LIMITED
WARRANTY shall not be affected, and all rights and
obligations shall be construed and enforced as if this
LIMITED WARRANTY did not contain the particular
part or term held to be invalid.

42 Operator and Reference Manual

42

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 43 Friday, July 2, 2004 12:43 PM

Disclaimer of Warranty - Customers Outside US of the remaining portion of the DISCLAIMER OF

WARRANTY shall not be affected, and all rights and
(This Disclaimer of Warranty applies only to products sold
obligations shall be construed and enforced as if this
outside the United States of America.)
DISCLAIMER OF WARRANTY did not contain the
Although the BioTrend Tri-optic Measurement Cell and the particular part or term held to be invalid.
BioTrend Sensor Cable, hereafter referred to as accessories,
have been carefully designed, manufactured and tested
prior to sale, the accessories may fail to perform their
intended functions satisfactorily for a variety of reasons.
The warnings contained in the accessories labeling provide
more detailed information and are considered an integral
part of this DISCLAIMER OF WARRANTY. Medtronic,
therefore, disclaims all warranties, both express and
implied, with respect to the accessories. Medtronic shall not
be liable for any incidental or consequential damages
caused by any use, defect or failure of the accessories,
whether the claim is based on warranty, contract, tort or
otherwise.
The exclusions and limitations set out above are not
intended to, and should not be construed so as to
contravene mandatory provisions of applicable law. If any
part or term of this DISCLAIMER OF WARRANTY is held
by any court of competent jurisdiction to be illegal,
unenforceable or in conflict with applicable law, the validity

Operator and Reference Manual 43

43

85652 Rev 3.0

 BIOENM1.CH 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 44 Friday, July 2, 2004 12:43 PM

44 Operator and Reference Manual

44

85652 Rev 3.0

85652_bc.fm 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 1 Friday, July 2, 2004 12:43 PM

85652 Rev 3.0

 85652_bc.fm 7/2/04 Medtronic Confidential
UC199402529cEN
8.0 in x 5.0 in (203.2 mm x 127 mm)

Bioenm1.book Page 2 Friday, July 2, 2004 12:43 PM

Europe Asia-Pacific Americas United States

Europe/Africa/Middle East Japan Latin America Manufacturer
Headquarters Medtronic Inc. Medtronic
Medtronic Japan
710 Medtronic Parkway 710 Medtronic Parkway
Medtronic Europe Sàrl Solid Square West Tower 6F
Minneapolis, MN 55432-5604 Minneapolis, MN 55432-5604
Route du Molliau 31 580 Horikawa-cho, Saiwai-ku
USA USA
Case Postale Kawasaki, Kanagawa 210-0913
Internet: www.medtronic.com Internet: www.medtronic.com or
CH - 1131 Tolochenaz Japan
Tel. 763-514-4000 www.heartvalves.com
Switzerland Tel. 81-44-540-6112
Fax 763-514-4879 Tel. 1-763-514-6779
Internet: www.medtronic.co.uk Fax 81-44-540-6200
Fax 1-763-514-2877
Tel. 41-21-802-7000 Canada
Australia Toll-free in the USA:
Fax 41-21-802-7900 Medtronic of Canada Ltd.
Medtronic Australasia Pty. Ltd. 1-800-328-2518, ex. 6779
Medtronic E.C. Authorized Unit 4/446 Victoria Road 6733 Kitimat Road (24-hour consultation service)
Representative Gladesville NSW 2111 Mississauga, Ontario L5N 1W3
Canada Manufacturing Facility
Medtronic B.V. Australia
Tel. 905-826-6020 Medtronic Perfusion Systems
Earl Bakkenstraat 10 Tel. 61-2-9879-5999
Fax 905-826-6620 7611 Northland Drive
6422 PJ Heerlen Fax 61-2-9879-5100
Toll-free in Canada: Minneapolis, MN 55428-9947
The Netherlands
Asia 1-800-268-5346 USA
Tel. 31-45-566 8000
Medtronic International Ltd. Tel. 1-612-944-7784
Fax 31-45-566 8668
Suite 1602 16/F, Manulife Plaza Fax 1-612-944-7557
The Lee Gardens, 33 Hysan Avenue Toll-free in the USA:
Causeway Bay 1-800-328-3320
Hong Kong Technical Support Toll-free:
Tel. 852-2891-4068 1-800-433-4311
Fax 852-2591-0313 Product Orders Toll-free:
1-800-854-3570

© Medtronic, Inc. 2004

*85652C*
All Rights Reserved
85652 Rev. 3.0
June 2004

85652 Rev 3.0

Blank Inside Title Page—For Position Only

Do Not Print!