| Patient population |
Adult and pediatric patients (age 3 and above). |
| Method of measurement |
Oscillometric |
| Initial inflation pressure |
160mmHg +/- 20mmHg |
| Blood pressure range (mmHg) |
60 < Systolic BP < 270, 30 < Diastolic BP < 170 |
| Blood pressure accuracy |
Measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or automated sphygmomanometers. |
| Blood pressure determination time |
35-40 seconds typical for Adult cuff |
| Heart rate range |
30-200 bpm +/- 2% or +/- 3 bpm, whichever is greater |
| Temperature range |
86°F (30.0°C) – 109.4°F (43.0°C) |
| Temperature accuracy |
+/- 0.2°F (+/-0.1°C) |
| Functional oxygen saturation range |
40-100% |
| Functional oxygen saturation accuracy |
70-100% +/- 2 digits (Note: because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be expected to fall within ± 2 digits of the value measured by a CO-oximeter.) |
| Operating conditions |
10°C (50°F) to 40°C (104°F) Less than 90% RH |
| Storage conditions |
-20°C (-4°F) to 55°C (131°F) Less than 90% RH |
| Power |
External power supply for non-battery version: Globtek model: GTM21089-1506-T3 (SunTech part number: 19-0013-00) External power supply for Battery version, rechargeable by Globtek model: GTM21089-1509-T3 (SunTech part number 19-0014-00) |
| Calibration |
Check once per year for BP and Temperature |
| Safety systems |
Independent hardware over-pressure circuit and redundant software overpressure algorithm to limit cuff pressure to less than 330 mmHg. Independent hardware timing circuit and redundant software timer algorithm to limit the duration of a blood pressure cycle to less than 180 seconds. |
| Dimensions |
Length = 5.5 inches, Height = 11.5 inches, Width = 3.8 inches; Length =14.0 cm, Height = 29.2 cm, Width = 9.7 cm |
| Standards |
UL60601-1, CAN/CSA C22.2 601-1 IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-4, ISO 9919, AAMI SP10:2002, ASTM E 1112, EN 12470-3 Meets “Non-invasive Sphygmomanometers — General Requirements & Supplementary Requirements for Electro-Mechanical BP Measuring Systems”, EN 1060-1, EN 1060-3 |
| Classification |
Protection against electric shock: Class II (for non-battery version), Internally Powered Equipment (for battery version); Applied parts: Type BF; Mode of operation: Continuous |