Spacelabs Healthcare 76A91341-600 91341-05 User Manual Exhibit G 1
Spacelabs Healthcare, Inc. 91341-05 Exhibit G 1
Contents
- 1. User Manual 1
- 2. User Manual 2
User Manual 1
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| Mirror Download [FCC.gov] | |
| Document ID | 259820 |
| Application ID | kWJIYpt3QfjRCEzP8dIjZg== |
| Document Description | User Manual 1 |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 18.69kB (233647 bits) |
| Date Submitted | 2002-07-30 00:00:00 |
| Date Available | 2002-09-24 00:00:00 |
| Creation Date | 2002-07-23 14:46:10 |
| Producing Software | Acrobat Distiller 5.0 (Windows) |
| Document Lastmod | 2002-07-26 14:28:17 |
| Document Title | Microsoft Word - Exhibit G User Manual 1.doc |
| Document Creator | PScript5.dll Version 5.2 |
| Document Author: | Vicki Albertson |
Exhibit G: User Manual 1 FCC ID: CM676A91341-600 91343 Digital Telemetry Multiparameter Transmitter Ultraview® Digital Telemetry 91341, 91343, 91347, 90478, 90479-A 91341/47 Digital Telemetry ECG Transmitters ■ Operation in the Wireless Medical Telemetry Service (WMTS) bands (608-614, 1395-1400, 1427-1429.5, 1429-1431.5 MHz). ■ Approved to operate under FCC Part 95 rules. ■ ECG and multiparameter transmitter. ■ ECG, SpO2, and NIBP (optional) for ambulatory patients. ■ Touchscreen control of all module functions and compatible with all Ultraview Care Network™ monitors. ■ Lightweight, water resistant transmitters. ■ Tunable 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 receiver’s 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. ■ Expanded central monitoring of ambulatory patients outside central antenna coverage. Diversity Antenna System Ultraview 1030/1050 90479-A Modular Receiver Housing 90478 Modular Receiver 90217 ABP Monitor Page 1 of 6 Ultraview Digital Telemetry 91341, 91343, 91347, 90478, 90479-A 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-v, refered to input (rti), at 30 Hz bandwidth CMRR — > 85 dB (monitor mode) QRS Detection — Detects QRS complexes with durations of 40 to 120mS and 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 MΩ 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 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. Alarms for absolute minimum and maximum ST levels; changes in ST level over the last 5 minutes. Displays — ST values: minimum/maximum/ current ST segment deviation and 5 minute averaged segments for the last 30 minutes. Measurement Points — Adjustable ST, PR, and J Points Trends — Up to 24 hours of trend data can be displayed in 1.5-, 3-, 6-, 12-, or 24-hour time tracks. PATIENT MONITOR 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; heart rates > 300 bpm are displayed as “+++”. 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 Display Bandwidth — Two settiings: 0.5 to 30 Hz ±10% (-3 dB) in monitor mode, and 0.05 to 30 Hz ±25% (-3 dB at 50 mm per second) in extended mode. 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. Page 2 of 6 Ultraview Digital Telemetry 91341, 91343, 91347, 90478, 90479-A SPECIFICATIONS NIBP Display Transmitter Physical Dimensions (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 (91341, 91343, 90347) ECG Transmission — View 2 of 7 available leads from two vectors (91341) or four vectors (91343, 91347) synchronized RF digital signal. Electrode Configuration — Individually replaceable DIN standard safety lead wires. Local lead fault indicators for each lead wire. Multiparameter 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 — 1 mW ERP, typical Spectral Efficiency — 0.11 bps/Hz External Indicator — Yellow LED flashes when battery level is low 91343 (Multiparameter) 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) 91341/47 (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) MODULAR RECEIVER Module Includes: Module Configuration Manager capability (refer to the Module Configuration Manager chapter of the Ultraview Care Network Operations Manual [P/N 070-1001-16] 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 Sensitivity — Usable ECG signal to -95 dBm Battery — 9 V battery; refer to Table 1 for battery life expectancy WMTS Frequency Band Option — -05: 608-614 MHz -09: 1395-1400 MHz 1427-1429.5 MHz 1429-1431.5 MHz Page 3 of 6 Ultraview Digital Telemetry 91341, 91343, 91347, 90478, 90479-A SPECIFICATIONS 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 or classes 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, 1395 to 1400 MHz V — Band operation, 1427 to 1431.5 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 100–120 VAC, 50/60 Hz, 2A; 220–240 VAC, 50/60 Hz, 1A ENVIRONMENTAL REQUIREMENTS Operating — Temperature: 50° to 104° F (10° to 40° C) Humidity: 95% (non-condensing) Altitude: 0 to 10,000 ft (0 to 3,030.3 m) Storage — Temperature: -40° to 149° F (-40° to 75° C) Humidity: 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 91341, 91343, 90347, and 90478, approved by FCC and Industry Canada (RSS - 210, 608-614 MHz operation only). 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. 91341/91343/91347 Transmitter Pouch Part Number: 015-0500-00 DIN Standard Safety ECG Lead Wire Set (5 wire) 25.2-inch snap Part Number: 012-0605-00 Receiver Housing Protective Cover Part Number: 200-0180-00 Whip Antenna (UHF) 608 to 614MHz 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 Page 4 of 6 Ultraview Digital Telemetry 91341, 91343, 91347, 90478, 90479-A SPECIFICATIONS Nellcor Disposable SpO2 Sensors — Adult (N-25) (P/N 690-0006-00) 70–100%, ±2% absolute saturation Neonatal (N-25) (P/N 690-0006-00) 70–100%, ±3% absolute saturation ABP Report Management System Part Number: 90121ABP Report Management System Adaptor Cable Part Number: 012-0097-02 ABP Adult Adapter Assembly Part Number: 714-0017-00 Pediatric (D-20) (P/N 690-0007-00) 70–100%, ±2% absolute saturation Adult (D-25) (P/N 690-0001-00) 50–69%, ±3% absolute saturation 70–100%, ±2% absolute saturation Nasal (R-15) (P/N 690-0005-00) 80–100%, ±3.5% absolute saturation Nellcor SpO2 Sensor Accuracy and Sensor Selections Nellcor Reusable SpO2 Sensors — Finger Clip (DS-100A) (P/N 690-0003-00) 70–100%, ±3% absolute saturation OXIBAND A/N (OXI-A/N) (P/N 690-0004-00) 70–100%, ±3% absolute saturation OXIBAND P/I (OXI-P/I) (P/N 690-0039-00) 70–100%, ±3% absolute saturation Infant (I-20) (P/N 690-0002-00) 50–69%, ±3% absolute saturation 70–100%, ±2% absolute saturation Table 1: Transmitter Battery Service Life1 (hours) Battery Type 9 Volt Alkaline (ANSI/NEDA 1604A) 9 Volt Lithium (ANSI/NEDA 1604LC) ECG Only ECG and Continuous SpO2 ECG and 2 minute Episodic SpO2 ECG and 5 minute Episodic SpO2 ECG and 30 minute Episodic SpO2 40 120 60 100 104 106 Not Applicable 132 Not Applicable Not Applicable Not Applicable Not Applicable ECG Only ECG and Continuous SpO2 ECG and 2 minute Episodic SpO2 ECG and 5 minute Episodic SpO2 ECG and 30 minute Episodic SpO2 and NIBP 91343 48 24 36 38 91341/47 52 Not Applicable Not Applicable Not Applicable Load Conditions2 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. NIBP operations from a 90217 ABP Monitor sending readings to the 91343 Multi-parameter telemetry transmitter. The 90217 ABP monitor will inflate a standard size adult cuff at least 240 times with alkaline batteries. 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 Medical’s published product data sheets. Spacelabs Medical cannot, and does not, guarantee interference-free telemetry operation. Page 5 of 6 Ultraview Digital Telemetry 91341, 91343, 91347, 90478, 90479-A Spacelabs Medical, Inc. 15220 N.E. 40th Street P.O. Box 97013 Redmond, WA 98073-9713 Telephone: (425) 882-3700 Fax: (425) 885-4877 Telex: 4740085 SPL UI Ultraview, Ultraview Care Network, 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. www.spacelabs.com © Spacelabs Medical, Inc. 2002 061-1317-00 Rev. A 07/2002 Page 6 of 6
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