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Standard Operating Procedure Onecheck Automatic Sphygmomanometer Ref. No.

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UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Page 1 of 15 Valid for: 2 years from approval UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Valid for: 2 years from approval 1. Scope This Standard Operating Procedure (SOP) applies to the staff and students using the OneCHECK Automatic Sphygmomanometer in the Pharmacy Practice Resource Unit (PPRU) at the Pharmacy Department, University of Malta. 2. Objective To describe the procedure for set-up, operation, recording and recalling of results and troubleshooting of the OneCHECK Automatic Sphygmomanometer. 3. Definitions 3.1. Blood Pressure (BP): Pressure exerted on the artery tube while blood flows through the arteries. 3.2. Cuff: Band wrapped around the arm to restrict blood flow during BP measurement. The cuff is suitable for use if the arrow falls within the solid colour line. If the arrow falls outside the solid colour line, a cuff with another circumference is needed. The colour strip indication should be positioned closer to the elbow with the tube pointing in the direction of the arm. 3.3. Diastolic BP: Minimum pressure in the arteries when the heart is at rest. 3.4. Main artery: The aorta; it originates from the left ventricle and extends downwards to the abdomen where it branches into smaller arteries transporting oxygenated blood to all the body. It is located by pressing two fingers approximately 2cm above the bend of the elbow on the inside of the left arm; where the pulse is felt to be the strongest, the main artery is present. 3.5. ON/OFF/START key: Once pressed, all digits will light up, checking the display functions. The checking procedure will be completed in a few seconds. The last measurement values will be shown and after all the symbols appear on the display, a beep will alert the user to take the measurement. 3.6. Pulse Rate: Number of pulsations noted in a peripheral artery per unit of time. 3.7. Systolic BP: Maximum pressure being exerted when the heart is contracting. Page 2 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE Valid for: 2 years from approval ONECHECK AUTOMATIC SPHYGMOMANOMETER 3.8. WHO BP Classification Low BP Systolic Diastolic <100 <60 Normal BP (Green) 100-139 60-89 Types of High BP Mild Medium Serious (Yellow) (Orange) (Red) 140-159 160-179 ≥180 90-99 100-109 ≥110 4. Responsibility 4.1. The members of the Department of Pharmacy (staff and students) are responsible for following this SOP. 4.2. The designated Laboratory Officer or Laboratory Assistant is responsible for ensuring that this SOP is followed. 5. Procedure 5.1. Diagram of OneCHECK Automatic Sphygmomanometer a: Cuff b: Pulse rate c: Pulse indicator d: ON/OFF/START Key e: Diastolic BP f: Systolic BP Page 3 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER 5.2. Set-up 5.2.1. 5.2.2. 5.2.3. 5.2.4. 5.3. Press down and lift the battery cover to open the battery compartment. Install or replace 4 “AA” sized batteries in the battery compartment. Click in the bottom hooks first to replace the battery cover. Push in the top end of the battery cover. Applying the Cuff 5.3.1. 5.3.2. 5.3.3. 5.3.4. 5.3.5. 5.3.6. 5.3.7. 5.3.8. 5.3.9. 5.4. Valid for: 2 years from approval Plug the cuff connecting tube into the unit. Wrap the cuff around the arm. Put left arm through the cuff loop. Turn left palm upwards and place the edge of the arm cuff at approximately 1.5 to 2.5cm above the inner side of the elbow joint (SOP/PD/236_01/A1a). Tighten the cuff by pulling the end of the cuff (SOP/PD/236_01/A1b). Centre the tube over the middle of the arm. Press the hook and loop material together securely allowing room for 2 fingers to fit between the cuff and the arm; Position the artery mark over the main artery on the inside of the arm. Centre the tube over middle of the arm. Lay arm on a table, palm upwards, so that the cuff is at the same level as the heart (SOP/PD/236_01/A2) ensuring that the tube is not kinked. Measurement procedures 5.4.1. 5.4.2. 5.4.3. 5.4.4. Press the ON/OFF/START key. Allow cuff to inflate when the monitor is “Ready to measure” and a flashing “0” appears on the LCD screen. Allow the arm band to deflate after another beep is heard which indicates that the measurement has finished. Record the systolic pressure, diastolic pressure and pulse rate which would be shown simultaneously on the LCD screen. Page 4 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER 5.5. Valid for: 2 years from approval Troubleshooting Symptoms No display when the ON/OFF/START key is pressed Control Have the batteries run down? Are the batteries positioned the wrong way round? EE mark shown on Is the cuff placed display or the blood correctly? pressure value is displayed excessively Did patient talk or low (high) move? Was the cuff shaken when measuring? Refer to SOP/PD/236_01/A3. Page 5 of 15 Correction Replace them with new alkaline batteries. Re-insert the batteries in the correct positions. Wrap the cuff properly so that it is positioned correctly. Measure again, staying still. Keep the wrist steady during measurement. UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER 5.6. Flow Charts 5.6.1. Set-up Start Press down and lift the battery cover to open the battery compartment Install or replace 4 “AA” sized batteries in the battery compartment Click in the bottom hooks first to replace battery cover Push in the top end of the battery cover End Page 6 of 15 Valid for: 2 years from approval UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER 5.6.2. Applying the cuff Start Plug the cuff connecting tube into the device Wrap cuff around the arm Put left arm through the cuff loop Turn left palm upwards and place the edge of the arm cuff at approximately 1.5-2.5cm above the inner side of the elbow joint (SOP/PD/236_01/A1a) Tighten the cuff by pulling the end of the cuff (SOP/PD/236_01/A1b) Centre the tube over the middle of the arm Press the hook and loop material together securely allowing room for 2 fingers to fit between the cuff and the arm; Position the artery mark over the main artery on the inside of the arm Centre the tube over the middle of the arm Lay arm on a table (palm upwards) so the cuff is at the same level as the heart (SOP/PD/236_01/A2) End Page 7 of 15 Valid for: 2 years from approval UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER 5.6.3. Measurement procedures Start Press the ON/OFF/START key Allow cuff to inflate when the monitor is “Ready to measure” and a flashing “0” appears on the LCD screen Allow the arm band to deflate after another beep is heard which indicates that the measurement has finished Record the systolic pressure, diastolic pressure and pulse rate which would be shown simultaneously on the LCD screen End Page 8 of 15 Valid for: 2 years from approval UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Valid for: 2 years from approval 6. Precautions 6.1. 6.2. 6.3. 6.4. 6.5. 6.6. 6.7. 6.8. 6.9. Replace the batteries when the low battery icon appears on the display (SOP/PD/236_01/A3) or when the ‘ON/OFF/START’ key is pressed and nothing appears on display. Do not use rechargeable batteries. Remove the batteries from the device if it is not being used for a long time. The memory is not cancelled when the batteries are removed. Ensure that the tube is not kinked when the cuff is being applied. Ensure that the measurement is taken in a silent room, while not talking or moving and at least an hour after consuming a large meal. Do not use the device on patients under 12 years of age. Do not use thinner, alcohol or petrol to clean the monitor and cuff; Use only a slightly damp, soft cloth. Do not drop or shake the unit. Avoid exposure of the unit to extreme temperatures, humidity, direct sunlight and dust since the unit contains high-precision components which may be affected. 7. Reference OneCHECK® Automatic Arm Blood Pressure Monitor Instruction Manual. Italy: Artsana Group Pic Solution; 2010. Page 9 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Valid for: 2 years from approval 8. Appendices SOP/PD/236_01/A1a – Diagram of application of the cuff on the arm (1) SOP/PD/236_01/A1b – Diagram of application of the cuff on the arm (2) SOP/PD/236_01/A2 – Diagram of the cuff at the same height as the heart SOP/PD/236_01/A3 – Table with icons and their cause/action 9. Revision History Version Number 01 Amendments/ Reasons for change Initial Release Page 10 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Valid for: 2 years from approval SOP/PD/236_01/A1a – Diagram of application of the cuff on the arm (1) Page 11 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Valid for: 2 years from approval SOP/PD/236_01/A1b – Diagram of the application of the cuff on the arm (2) Page 12 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Valid for: 2 years from approval SOP/PD/236_01/A2 – Diagram of the cuff at the same height as the heart Page 13 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE Valid for: 2 years from approval ONECHECK AUTOMATIC SPHYGMOMANOMETER SOP/PD/236_01/A3 – Icons and their cause/action Icons Cause/Action Low battery indicator: appears when batteries should be replaced Management error: Ensure the plug is securely connected to the air socket and measured again calmly. Wrap the cuff correctly and keep arm steady during measurement. If error keeps occurring, return the device to the local agent. Air circuit anomaly: Ensure the plug is securely connected to the air socket and measure again calmly. If error keeps occurring, return the device to the local agent. Pressure exceeding 300mmHg: Switch the unit off and measure again quietly. If error keeps occurring, return the device to the local agent. Data Error: Remove the batteries, wait for 60 seconds, and reload. If error keeps occurring, return the device to the local agent. Page 14 of 15 UNIVERSITY OF MALTA FACULTY OF MEDICINE & SURGERY PHARMACY DEPARTMENT Ref. No. SOP/PD/236_01 STANDARD OPERATING PROCEDURE ONECHECK AUTOMATIC SPHYGMOMANOMETER Valid for: 2 years from approval Exceeding Measurement Range: Measure again calmly. If error keeps occurring, return the device to the local agent. Calibration Indicator: Appears when the monitor requires re-calibration. Recalibration recommended. Page 15 of 15