Philips Healthcare Inc.

Philips IntelliVue Clinical Information Portfolio Release D.XX, where XX is 00, 01, 02 or 03.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, including states of CA, DC, FL, IL, IN, KY, MA, MD, ME, NJ, NY, OK, RI, TX, VA, VT, and WV; and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and the UNITED KINGDOM.

Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System || Software Version D.00 through D.03.

Software Versions: A.00.48, and A.00.4O

Cardiovascular Devices

2

No

Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates

SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or SPo2, Predictive Temperature, and Recorder || Part Number: 863067 and 453564041491 || The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Software Versions: A.02.33, A.01.18, A.00.34, A.00.28, and A.00.26

Cardiovascular Devices

2

No

Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates

SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time || Part number: 863069,863070,863071,863072,863073,863074,453564041251,453564041261, || 453564041271,453564041281,453564041291, || 453564041301 || The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Software Versions: A.01.51, A.01.45, A.01.42, A.01.40, A.00.58, A.00.55, A.00.52, A.00.51, and A.00.41

Cardiovascular Devices

2

No

Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates

SureSigns Patient Monitors (VM3, VM4. VM6. VM8): || VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display || VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4" display || VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4" display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4" display || VM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2, SPo2 Bedside Patient Monitor with 10" display or 3/5 Lead ECG, NBP, Temp, IPB, SPo2 Bedside Patient Monitor with 10" display || Part number: || VM3: || 863077,453564041661,453564050161, || VM4: || 863063,453564024371,453564021961, || 453564024401,453564021971 || VM6: || 863064,863065,453564024421,453564022001, || 453564024441 || VM8: || 453564022041,863066,863068,453564022081, 453564024461, 453564024481 || The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

S/W Version D.02

Cardiovascular Devices

2

No

MD, RI, WV, and TX Australia Belgium Denmark France Italy Malaysia Singapore Spain Switzerland Taiwan United Arab Emirates United Kingdom and Ireland

IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.