Spacelabs Healthcare 76A90343-04 90343/90347 Digital Telemetry Transmitter User Manual 2

Spacelabs Healthcare, Inc. 90343/90347 Digital Telemetry Transmitter 2

Contents

User Manual 2

EXHIBIT G – User Manual 2
FCC ID CM676A90343-04
SPECIFICATIONS
PARAMETER CHARACTERISTICS
ECG
Maximum Input ±4 mV ( ±10%)
DC Offset — Up to ±300 mV, with no more than
2% signal amplitude degradation
Overdrive Recovery Time — < 1 second circuit
settling time with offset voltage < 500 mV
Noise — < 30 µV p-p, refered to input (rti), at 30
Hz bandwidth
CMRR > 85 dB (monitor mode)
QRS Detection Detects QRS complexes with
amplitudes of 0.2 to 4.0 mV (adult) or 0.15 to
4.0 mV (neonatal)
Defibrillator Protection — Meets IEC
60601-2-27, AAMI EC-13
Resolution — 2.5 µV per LSB, rti
Input Impedance — > 10 M minimum
differential at 10 Hz
Gain Accuracy ±5 %
Pacer Rejection — Baseline shift < 0.2 mV
(measured at ECG x 1,000 output)
Pacer Detection — Detects pacer pulses of ±2
mV to ±700 mV with pulse widths of 0.2 to 2
msec and rise times 10% of width not to
exceed 100 µsec
Signal Bandwidth — 0.05 to 30 Hz ±10% (-3
dB)
Sample Rate — 120 samples per second
Ultraview
Digital
Telemetry
90343, 90347,
90478-Q,-T,-V,
90479-A
602-620 MHz frequency operation,
including 608-614 MHz Wireless Medical
Telemetry Service (WMTS) band
Touchscreen control of all module
functions and compatible with all
Ultraview Care Network monitors
Multi-parameter telemetry monitoring
ECG, SpO2, and NIBP (optional)
Lightweight, water resistant transmitters
Diversity antenna system
Tunable modular receiver
Modular receiver converts bedside
monitors to telemetry operation
Multi-lead ECG with ST segment analysis
option; comprehensive arrhythmia and
ST trending
Module Configuration Manager enables
the hospital to customize the receivers
ECG patient monitoring functions to
specific patient populations, clinical
protocols, or operating preferences
Graded alarm functions enables the
hospital to define high, medium, or low
alarm tones according to critical,
warning, or advisory event severity
Diversity Antenna
System
90217 ABP Monitor
90478 Modular Receiver
90479-A Modular
Receiver Housing
90343
Digital
Telemetry
Multi-parameter
Transmitter
90347
Digital
Telemetry
ECG
Transmitter
(options Q, T, and V)
mmHg
mmHg model 90217
• Install three, fresh “AA cells
( 1.5 Alkaline or NiCad).
Observe polarities.
SPECIFICATIONS
Ultraview
Digital
Telemetry
90343,
90347,
90478-Q,
90478-T,
90478-V,
90479-A
SpO2
SpO2 Sensor Interface
Red LED drive (max): 175 mA peak at 10%
duty cycle
IR LED drive (max): 105 mA peak at 10% duty
cycle
SpO2 Measurement Method Functional
saturation (oxygen saturation of functional
hemoglobin)
SpO2 Measurement Mode
Continuous, episodic (2 minutes, 5 minutes,
and 30 minutes) sampling intervals; factory
default setting is continuous
ST Segment Analysis
Resolution 0.08 mm
Range ±9 mm (1 mV = 10 mm)
Leads ST Segment Analysis continously
performed on up to seven leads
Alarms Single lead or multiple leads; individual
leads can be deselected
Trends Up to 24 hours of trend data can be
displayed in 1.5-, 3-, 6-, 12-, or 24-hour time
tracks
DISPLAY CHARACTERISTICS
ECG Display
Heart Rate Range 30 to 300 bpm; heart rates
> 300 bpm are displayed as +++
Heart Rate Alarm Limits High: 5 to 300 bpm,
Low: 0 to 200 bpm; alarms automatically
enabled over a range of 40 (adult) or 100
(neonatal) to 300 bpm
Accuracy ±1% or ±2 beats per minute
(whichever is greater)
Numeric Update Rate Every 3 seconds or
immediately at the onset of an alarm
Trace Sweep Speeds 50, 25, 12.5 mm/sec
SpO2 Display
Measurement Range 30 to 100% O2
Saturation
Saturation Accuracy: Sensor Dependent
Saturation Resolution ±1%
Pulse Rate Range 30 to 250 bpm
Pulse Rate Resolution 1 bpm
Alarms High and low saturation values; factory
default limits are: high 100%; low 85%
High range: 31% 100%
Low range: 30% 99%
Numeric Update Rate Every 2 seconds for
continuous SpO2 readings
NIBP Display
(Refer to specifications for the 90217 ABP
Monitor)
Measurement Range (adult only)
Systolic: 8.0 35.0 kPa (60 260 mmHg)
Diastolic: 9.0 27.0 kPa (30 200 mmHg)
Mean: 5.3 31.0 kPa (40 230 mmHg)
Pressure Accuracy ±2% or ±3 mmHg
(whichever is greater)
Resolution 1 mmHg
Time Between Readings selectable, from 6 to
120 minutes
Alarms High and low alarms for all measured
parameters
High range: 8.0 35.0 kPa
(60 260 mmHg)
Low range: 4.0 27.0 kPa
(30 200 mmHg)
TRANSMITTERS (90343, 90347)
ECG Transmission View 2 of 7 available
leads from four vectors (90343, 90347)
synchronized RF digital signal
Electrode Configuration Individually
replaceable DIN standard safety lead wires
Multi-parameter Transmission (90343) SpO2
(saturation, SpO2 sensor status, pulse rate)
and optional NIBP (systolic, diastolic, mean
pressure, measurement time, alarm
conditions) with the model 90217 ABP monitor
Additional Data Transmitted Patient record,
low battery indicator, pacer flag, patient ID
code, and electrode connection status
Output Power 4 mW ERP, typical
Spectral Efficiency 0.11 bps/Hz
External Indicator Yellow LED flashes when
battery level is low
Battery 9 V battery; refer to Table 1 for battery
life expectancy
Frequency Band Option
-04: 602-608 MHz
-05: 608-614 MHz
-06: 614-620 MHz
TRANSMITTER PHYSICAL DIMENSIONS
90343 (Multi-Parameter)
Height: 5.25 in (13.3 cm)
Width: 2.85 in (7.2 cm)
Depth: 1.18 in (2.9 cm)
Weight (w/out battery): 8.5 oz (241.0 gm)
90347 (ECG-only)
Height: 5.25 in (13.3 cm)
Width: 2.85 in (7.2 cm)
Depth: 0.98 in (2.5 cm)
Weight (w/out battery): 6.78 oz (192.7 gm)
SPECIFICATIONS Ultraview
Digital
Telemetry
90343,
90347,
90478-Q,
90478-T,
90478-V,
90479-A
MODULAR RECEIVER
(90478 Options Q, T, and V)
Module Configuration Manager capability (refer
to the Module Configuration Manager chapter
of the Ultraview Care Network Operations
Manual for complete feature specifications)
Trends (with appropriate mainframe option) 24
hours of trended data can be displayed in 1.5-,
3-, 6-, 12-, or 24-hour segments; data is stored
in 1-minute resolution
High Level Analog Output
ECG 1: Used for defibrillator
synchronization
Connector: 3-conductor TT phone jack
Dynamic Range: ±5 mV (±10%), rti
Gain: ECG x 1000 (±5%)
Bandwidth: 0.05 to 30 Hz ±10% (-3 dB)
Module Parameter Count This module counts
as 1 or 2 parameters when computing
parameter capacity for monitors
1 displayed ECG lead = 1 parameter
2 displayed ECG leads = 2 parameters
Receiver Options
The following system configuration options are
available in the 90478
A Basic Arrhythmia: High and low heart rate,
asystole and ventricular fibrillation (2 leads)
B MultiView I Arrhythmia Enables users to
review trends of abnormals per minute;
provides additional alarms for abnormals per
minute and abnormals in a row (2 leads)
C MultiView II Arrhythmia Enables users to
review the dominant morphology as well as
episodes orclasses of ventricular fibrillation,
ventricular tachycardia (runs), couplets,
single abnormals, tachycardia, pauses,
ventricular and atrio-ventricular pacing;
provides additional alarms for abnormals in a
row, abnormals per minute, and tachycardia
(2 leads)
S ST segment analysis/review/trend (2 leads)
Q Band operation, 608 to 614 MHz
T Band operation, 602 to 608 MHz
V Band operation, 614 to 620 MHz
RECEIVER ELECTRICAL REQUIREMENTS
Power Consumption 5.0 watts
External Indicators LED lights when user
accesses control
RECEIVER PHYSICAL DIMENSIONS
Height: 4.46 in (11.32 cm)
Width: 2.24 in (5.68 cm)
Depth: 7.00 in (17.78 cm)
Weight: 2.4 lbs (1.11 kg)
RECEIVER HOUSING (90479-A)
Accommodates up to 8 modular receivers
HOUSING PHYSICAL DIMENSIONS
Height: 12.0 in (30.5 cm)
Width: 13.5 in (34.3 cm)
Depth: 17.5 in (44.5 cm)
(includes protective cover)
Weight: 32.0 lbs (14.6 kg)
(without modules loaded)
RECEIVER HOUSING POWER
REQUIREMENTS
100120 VAC, 50/60 Hz, 2A; 220240 VAC,
50/60 Hz, 1A
ENVIRONMENTAL REQUIREMENTS
Operating
Temperature: 50o to 104o F (10o to 40o C)
Humidity: 10 to 95% (non-condensing)
Altitude: 0 to 10,000 ft (0 to 3,030.3 m)
Storage
Temperature: -40o to 149o F (-40o to 75o C)
Humidity: 10 to 100% (non-condensing)
Altitude: -500 to 40,000 ft (-151.5 to
12,121.2 m)
Water Resistance Meets EN60529 IPX1
REGULATORY APPROVALS
All models are ETL listed and meet UL544 or
UL2601-1 standard for electrical safety;
approved by CSA; Models 90343, 90347, and
90478, approved by FCC (47CFR 15.242 and
47CFR) and Industry Canada (RSS - 210,
608-614 MHz operation only)
SPECIFICATIONS
Ultraview
Digital
Telemetry
90343,
90347,
90478-Q,
90478-T,
90478-V,
90479-A
Spacelabs Medical, Inc.
15220 N.E. 40th Street
P.O. Box 97013
Redmond, WA 98073-9713
(425) 882-3700
Ultraview, Ultraview Care Network,
PCMS, and Multiview are trademarks of
Spacelabs Medical, Inc.
Other brands and product names are
trademarks of their respective owners.
All specifications are subject to change
without notice.
© Spacelabs Medical, Inc. 2000
061-0801-00 Rev. D 9/2000
ACCESSORIES
Please refer to the Spacelabs Medical Supplies
Catalog for availability of ECG lead wires and
electrodes, blood pressure cuffs, and SpO2
sensors from Spacelabs Medical
90343/90347 Transmitter Pouch
Part Number: 015-0500-00
DIN Standard Safety ECG Lead Wire Set (5 wire)
24 snap
Part Number: 012-0605-00
Receiver Housing Protective Cover
Part Number: 200-0180-00
Whip Antenna (UHF)
Part Number: 117-0040-00
Belt Clip
Part Number: 344-0020-00
SpO2 Adapter Cable (Nellcor)
Part Number: 700-0014-00
ABP Telemetry Adapter Cable
Part Number: 700-0015-00
ABP Pouch
Part Number: 015-0501-00
ABP Shoulder Strap
Part Number: 016-0262-00
ABP Waist Belt
Part Number: 016-0080-00
ABP Report Management System
Part Number: 90121
ABP Report Management System Adaptor Cable
Part Number: 012-0097-02
ABP Adult Adapter Assembly
Part Number: 714-0017-00
NELLCOR SpO2 SENSOR ACCURACY
AND SENSOR SELECTIONS
Nellcor Reusable SpO2 Sensors
Finger Clip (DS-100A) (P/N 690-0003-00)
70100%, ±3% absolute saturation
OXIBAND A/N (OXI-A/N) (P/N 690-0004-00)
70100%, ±3% absolute saturation
OXIBAND P/I (OXI-P/I) (P/N 690-0039-00)
70100%, ±3% absolute saturation
Nellcor Disposable SpO2 Sensors
Adult (N-25) (P/N 690-0006-00)
70100% ±2% absolute saturation
Neonatal (N-25) (P/N 690-0006-00)
70100% ±3% absolute saturation
Pediatric (D-20) (P/N 690-0007-00)
70100% ±2% absolute saturation
Adult (D-25) (P/N 690-0001-00)
5069% ±3% absolute saturation
70100% ±2% absolute saturation
Nasal (R-15) (P/N 690-0005-00)
80100% ±3.5% absolute saturation
Infant (I-20) (P/N 690-0002-00)
5069% ±3% absolute saturation
70100% ±2% absolute saturation
1 Operational service life (in hours) assuming a new
alkaline battery (minimum 580 mAH capacity) or
lithium battery (minimum 1200 mAH capacity) used
until the local low battery indicator begins to flash.
2 NIBP operations from a 90217 ABP Monitor sending
readings to the 90343 Multi-parameter telemetry
transmitter. The 90217 ABP monitor will inflate a
standard size adult cuff at least 240 times with alkaline
batteries.
Table 1: Transmitter Battery Service Life1 (hours)
Battery
Type 9 Volt Alkaline (ANSI/NEDA 1604A) 9 Volt Lithium (ANSI/NEDA 1604LC)
Load
Con-
ditions2ECG
Only
ECG
and
Con-
tinuous
SpO2
ECG and
2 minute
Episodic
SpO2
ECG and
5 minute
Episodic
SpO2
ECG and
30 minute
Episodic
SpO2 and
NIBP ECG
Only
ECG
and
Con-
tinuous
SpO2
ECG
and 2
minute
Episodic
SpO2
ECG
and 5
minute
Episodic
SpO2
ECG
and 30
minute
Episodic
SpO2
90343 48 24 36 38 40 120 60 100 104 106
90347 52 Not
Applicable Not
Applicable Not
Applicable Not
Applicable 132 Not
Applicable Not
Applicable Not
Applicable Not
Applicable
Medical telemetry spectrum allocations may be assigned to frequencies already allotted to other priority
users. This means that telemetry operations may be exposed to radio frequency interference that may
disrupt or impede telemetry patient monitoring. Additionally, medical telemetry spectrum allocations
may be changed by government action and Spacelabs Medical accepts no responsibility for such
changes, including the possibility that the product may not operate in the modified permissible
spectrum ranges other than those expressly set forth in Spacelabs Medicals published product data
sheets. Spacelabs Medical cannot, and does not, guarantee interference-free telemetry operation.

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